COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT REPORT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures

EN EN
EUROPEAN
COMMISSION
Brussels, 19.12.2022
SWD(2022) 435 final
PART 1/5
COMMISSION STAFF WORKING DOCUMENT
IMPACT ASSESSMENT REPORT
Accompanying the document
Proposal for a Regulation of the European Parliament and of the Council
amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council
on classification, labelling and packaging of substances and mixtures
{COM(2022) 748 final} - {SEC(2022) 452 final} - {SWD(2022) 434 final} -
{SWD(2022) 436 final}
Offentligt
KOM (2022) 0748 - SWD-dokument
Europaudvalget 2022
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Table of contents
1 INTRODUCTION ................................................................................................................................ 4
1.1 Policy context .................................................................................................... 4
1.2 Legal context (see Annex 5 for more details) ................................................... 5
2 PROBLEM DEFINITION .................................................................................................................... 7
2.1 The problem - Insufficient health and environment protection from
hazardous substances in the internal market for chemicals............................... 7
2.2 The problem drivers .........................................................................................15
2.3 How likely is the problem to persist?...............................................................17
3 WHY SHOULD THE EU ACT? ........................................................................................................ 19
3.1 Legal basis........................................................................................................19
3.2 Subsidiarity: Necessity of EU action................................................................19
3.3 Subsidiarity: Added value of EU action...........................................................20
4 OBJECTIVES: WHAT IS TO BE ACHIEVED? ............................................................................... 20
4.1 General objectives ............................................................................................20
4.2 Specific objectives............................................................................................20
5 WHAT ARE THE AVAILABLE POLICY OPTIONS? .................................................................... 21
5.1 What is the baseline from which options are assessed? ...................................22
5.2 Description of the policy options .....................................................................27
5.3 Options discarded at an early stage ..................................................................34
6 WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? ........................................................... 35
6.1 Classification of chemical hazards (Policy Option 1) ......................................35
6.2 Communication of chemical hazards (Policy Option 2) ..................................40
6.3 Addressing main legal gaps and ambiguities (Policy Option 3) ......................41
7 HOW DO THE OPTIONS COMPARE?............................................................................................ 44
7.1 Classification of chemical hazards (Policy Option 1) ......................................44
7.2 Communication of chemical hazards (Policy Option 2) ..................................44
7.3 Addressing main legal gaps and ambiguities (Policy Option 3) ......................45
8 PREFERRED OPTION ...................................................................................................................... 49
8.1 Description of combined preferred option .......................................................49
8.2 Potential for burden reduction and simplification............................................51
8.3 Application of the ‘one in, one out’ approach..................................................52
9 HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED?.................................. 52
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ANNEX 1 – PROCEDURAL INFORMATION............................................................................................. 55
ANNEX 2 – STAKEHOLDER CONSULTATION (SYNOPSIS REPORT) ................................................. 63
ANNEX 3 – WHO IS AFFECTED AND HOW? ........................................................................................... 83
ANNEX 4 – ANALYTICAL METHODS ...................................................................................................... 88
ANNEX 5 – THE CLP REGULATION AND OTHER PIECES OF CHEMICAL LEGISLATION........... 142
ANNEX 6 – SUMMARY OF THE FINDINGS OF THE FITNESS CHECK ON CHEMICAL
REGULATIONS (EXCEPT REACH) .......................................................................................................... 147
ANNEX 7 – BASELINE, DISCARDED MEASURES AND ASSESSMENT OF POLICY MEASURES. 150
ANNEX 8 – NEW HAZARD CLASSES...................................................................................................... 187
ANNEX 9 – HARMONISED REFERENCE VALUES ............................................................................... 242
ANNEX 10 – ALLOWING COM TO INITIATE CLH & IMPROVING PRIORITISATION OF CLH..... 262
ANNEX 11 - CONVERGENCE OF SELF-CLASSIFICATION.................................................................. 279
ANNEX 12 – HAZARD LABELLING ........................................................................................................ 325
ANNEX 13 – DIGITAL LABELLING......................................................................................................... 363
ANNEX 13A – STAKEHOLDER CONSULTATION – SYNOPSIS REPORT (DIGITAL LABELLING)423
ANNEX 13B – FACTUAL SUMMARY OF THE RESPONSES TO THE OPEN PUBLIC
CONSULTATION (DIGITAL LABELLING) ............................................................................................. 455
ANNEX 13C – LEGAL ANALYSIS (DIGITAL LABELLING)................................................................. 474
ANNEX 13D – OVERVIEW OF COSTS AND BENEFITS UNDER THE PREFERRED OPTION ......... 497
ANNEX 13E – DESCRIPTION OF THE ANALYTICAL METHODS USED IN PREPARING THE
IMPACT ASSESSMENT (DIGITAL LABELLING)................................................................................... 499
ANNEX 14 – EXEMPTION FROM THE SCOPE OF CLP FOR CERTAIN PRODUCTS ........................ 504
APPENDIX – EXEMPTION FROM THE SCOPE OF CLP FOR CERTAIN PRODUCTS:
LEGISLATIVE ANALYSIS AND LITERATURE REVIEW ..................................................................... 514
ANNEX 15 – INFORMATION ON ONLINE SALES OF CHEMICALS................................................... 562
ANNEX 16 – INFORMATION GAPS FOR POISON CENTRES............................................................... 608
ANNEX 17 – BIBLIOGRAPHY................................................................................................................... 626
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Glossary
Term or acronym Meaning or definition
CLP Regulation (EC) No 1272/2008 on the Classification,
Labelling and Packaging of Substances and Mixtures
CMR Carcinogenicity, mutagenicity, reproductive toxicity
D Driver
ECHA European Chemicals Agency
ED Endocrine Disruptor
EU European Union
GHS (United Nations) Globally Harmonized System of
Classification and Labelling of Chemicals
NGO Non-governmental organisation
REACH Regulation (EC) No 1907/2006 on the Registration,
Evaluation, Authorisation and Restriction of Chemicals
PBT and/ vPvB Persistent, Bioaccumulative and Toxic and/ very Persistent
and very Bioaccumulative
PMT and/ vPvM Persistent, Mobile and Toxic and/ very Persistent, very
Mobile
PO Policy Option
SME Small and medium-sized enterprise
SVHC Substance of Very High Concern (under REACH)
SDG Sustainable Development Goals (United Nations)
TFEU Treaty on the Functioning of the European Union
VAT Value-Added Tax
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1 INTRODUCTION
1.1 Policy context
Chemicals are the building blocks of all materials and products we produce and use and are
therefore important determinants of their overall safety and sustainability. All European citizens are
exposed in their daily life to chemicals; many may also use chemicals at work.
The EU is the second largest producer of chemicals in the world with €499.1 billion sales turnover
in 2020 (7.0% of EU manufacturing by turnover) and 14.4% of global sales1
. Within the EU, two
thirds of these sales are generated in four Member States: Germany (32.1%), France (13.5%), Italy
(10.7%) and the Netherlands (8.9%). Around 50% of chemicals, in terms of sales, produced by the
EU27 plus the UK, supply the other industrial manufacturing sectors (e.g., textiles, construction,
agriculture, transport, health, hygiene, housing, food).
The European Green Deal2
is the European Union’s growth strategy to set the EU on a course to
become a climate neutral, clean and circular economy by 2050. It has also set a goal to step up
protection of human health and the environment from hazardous chemicals and to move towards a
zero pollution ambition for a toxic-free environment, for which the Chemicals Strategy for
Sustainability3
adopted by the European Commission in 2020 was the first step, followed by the EU
Action Plan: ‘Towards Zero Pollution for Air, Water and Soil’4
. The Chemicals Strategy for
Sustainability defines a 2030 vision and objectives where all chemicals will be produced and used
safely and sustainably, so that their negative impacts on health and environment are avoided, while
their benefits for the economy and society can be fully exploited. The EU’s New Industrial Strategy
for Europe supports those objectives through a set of measures for the twin transition to a green and
digital economy, with a particular focus on strengthening the resilience of the single market,
supporting the EU’s strategic autonomy and business cases for the twin transition. That strategy
also entails building capacity and supporting SMEs in their transition to sustainability.
Given the very cross-cutting nature of chemicals, which constitute the basic elements of virtually
every material and product that we produce and use, the objectives of the Chemicals Strategy for
Sustainability are closely linked to the other goals of the European Green Deal, in particular climate
neutrality, circularity, biodiversity protection and the green and digital transition of the EU
industry. Those objectives also contribute to the achievement of the United Nations Sustainable
Development Goals (SDGs), of which 4 are directly relevant for chemicals: SDG #3 Good health
and well-being, SDG #6 Clean water and sanitation, SDG #9 Industry, innovation and
infrastructure, SDG #12 Ensure sustainable consumption and production patterns (see Annex 3 for
more details).
The Chemicals Strategy for Sustainability announced the revision of the Regulation on the
Classification, Labelling and Packaging of Substances and Mixtures (CLP), the Regulation on the
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as well as a
number of pieces of product sectorial legislation containing provisions on chemicals (e.g.
cosmetics, toys, food contact materials, etc.). In particular, the Chemicals Strategy for
Sustainability calls for the REACH and CLP Regulations to be reinforced as the EU’s cornerstones
1
CEFIC, Facts and Figures of the European Chemical Industry, 2022.
2
COM(2019) 640.
3
COM(2020) 667.
4
COM(2021) 400.
5
for regulating chemicals, and to be complemented by coherent approaches to assess and manage
chemicals in existing sectorial legislation, especially in relation to consumer products.
The targeted revision of CLP, as part of the Chemicals Strategy for Sustainability, was welcomed
by the Council5
and the European Parliament6
. It echoed former calls from the European Parliament
on tackling chemicals with endocrine disrupting properties. Industry positively responded to the
Chemicals Strategy for Sustainability7
while strongly calling for additional support and a
collaborative approach to deliver on chemical sustainability in the EU. Non-governmental
associations (NGOs) welcomed the targeted revision in the consultation on the Inception Impact
Assessment (see Annex 2).
This impact assessment focuses on the revision of the CLP and is based on the shortcomings
identified in recent evaluations8,9
of the CLP and of its interfaces with other EU legislation
regulating chemicals. It will assess how different measures can help achieving the goal of a toxic-
free environment while fostering the internal market for chemicals and competitiveness of the EU
industry10
. Since CLP provides for a horizontal approach to identify and classify the hazards related
to chemicals, its revision is a first necessary step for several elements of the revisions of REACH
and other sectorial legislation.
1.2 Legal context (see Annex 5 for more details)
The objectives of CLP are to protect human health and the environment from hazardous chemicals
and to facilitate the free movement of chemicals in the European market.
CLP focuses on the identification and classification of the intrinsic hazards of chemicals, i.e. the
hazardous effects of chemicals on human health or the environment, and on communicating them to
users of chemicals and decision makers (consumers, industry and authorities). Identifying the
intrinsic hazardous properties of substances to derive a hazard classification is the first step in
assessing chemical risks. The second step aims at quantifying at which dose the adverse effects
5
Council Conclusions on Sustainable Chemicals Strategy of the Union, 2021.
6
European Parliament, Resolution of 10 July 2020 on the Chemicals Strategy for Sustainability, 2020.
7
CEFIC, Chemical Strategy for Sustainability, consulted 3/4/2022.
8
SWD(2019) 199.
9
SWD(2020) 251.
10
Also in line with the EU Industrial Strategy COM(2021) 350 final and COM(2020) 102 final.
CLP in brief
CLP requires manufacturers, importers and downstream users to classify hazardous substances and
mixtures. CLP contains rules on how to classify chemicals. A classification can be harmonised and
applied across the EU to all duty holders. Such classification is adopted at EU level according to a
regulatory procedure. Where such harmonised classification does not exist, duty holders have to
assess and classify according to available data (‘self-classification’).
The hazard classification determines, amongst others, the appropriate labelling and packaging of
the chemicals in the supply chain, in particular to protect workers, consumers and the environment
(see Annex 5). Hazard communication also relies on notifications of substances which are self-
classified by industry and included in the CLP classification and labelling inventory, a public
database managed by ECHA. CLP also covers the notifications self-classifications of mixtures of
chemicals to poison centres, to provide adequate emergency health response.
6
happen, whose outcome is a reference value, and is currently performed outside CLP. Risk
management measures are adopted under REACH and relevant sectorial pieces of legislation (e.g.
cosmetics, toys, waste, detergents etc., see Figure 1 below. More details are available on the
interaction between legislation in Annex 5).
Figure 1: Mapping of the pieces of legislation according to the different steps of hazard and risk assessments
CLP follows the United Nations’ Globally Harmonized System (GHS) of classification and
labelling of chemicals setting up criteria for classification and communication of physicochemical,
health, and environmental hazards. GHS is partly established on a “building blocks” approach,
whereby each jurisdiction has the option to implement a GHS block into its own legislation11
. So
far, 83 countries worldwide implement the GHS12
. CLP implements the GHS criteria into EU
legislation, but complements them with certain elements from former EU legislation (Dangerous
Substances Directive13
and Dangerous Preparations Directive14
).
CLP, together with other pieces of EU legislation, was evaluated in 201915
. An additional and more
targeted Fitness Check was also published on endocrine disruptors16
. Those evaluations,
summarised in Annex 6, identified important issues and weaknesses holding CLP back from
delivering its full potential. These evaluations pinpointed nine potential areas of intervention:
 Introducing criteria for five outstanding new hazard classes (Annex 8)
 Providing harmonised reference values in addition to harmonised classification (Annex 9)
 Improving harmonised classification (Annex 10)
 Improving and streamlining industry’s self-classifications (Annex 11)
 Clarifying rules for hazard (physical) labelling (Annex 12)
 Introducing digital labelling (Annex 13)
 Reviewing the exemption of a number of chemical products from CLP (Annex 14)
 Addressing low compliance rate for online sales of chemicals (Annex 15)
 Closing notification gaps for poison centres (Annex 16)
11
Global implementation map of GHS, September 2021.
12
GHS Implementation, last updated 19 October 2021.
13
Directive 67/548/EEC.
14
Directive 1999/45/EC.
15
SWD(2019) 199.
16
SWD(2020) 251.
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2 PROBLEM DEFINITION
2.1 The problem - Insufficient health and environment protection from hazardous
substances in the internal market for chemicals
The chemicals Fitness Check concluded that the EU has the most advanced knowledge base on
chemicals globally. The EU has been overall successful in creating an efficiently functioning
internal market for chemicals and in reducing the risks to humans and the environment posed by
certain hazardous chemicals. However, the weaknesses identified in CLP hinder the capacity of all
market actors – in particular consumers, businesses and authorities - to base their decisions on
robust and relevant knowledge on the intrinsic properties of chemicals. The problem manifests
itself in three main areas, described in Table 1 and in the three following sections.
2.1.1 Hazardous chemicals are not comprehensively identified and classified
Hazardous chemicals cause harm to human health and the environment. While not all hazardous
chemicals raise the same concerns, certain chemicals cause for example cancers or affect the
immune, respiratory, endocrine, reproductive or cardiovascular system17,18,19
. Human biomonitoring
studies in the EU point to a high number of different hazardous chemicals present in human blood
and body tissue20,21
, including more than 200 synthetic chemicals identified in umbilical cord
blood. In addition, chemical pollution is one of the key drivers putting the environment at risk22
,
impacting and amplifying planetary crises such as climate change, degradation of ecosystems or
loss of biodiversity23
. In the EU, reports from the European Environment Agency provide the extent
of chemical contamination in water, soil and air compartments24
. 84% of Europeans are worried
about the impact of chemicals present in everyday products on their health, and 90% are worried
about their impact on the environment25
.
17
C&en, Linking pollution and infectious disease, 2019.
18
Science Daily, Environmental toxins impair immune system over multiple generations, 2019.
19
Substances such as PFOS and PFOA are associated with reduced antibody response to vaccination; EFSA, Scientific
opinion on PFAS.
20
European Commission, Study for the Strategy for the Non-Toxic Environment, p. 123.
21
European Human Biomonitoring Data.
22
L. Persson, B. M. Carney Almroth, C. D. Collins, S. Cornell, C. A. de Wit, M. L. Diamond, P. Fantke, M. Hassellöv,
M. MacLeod, M. W. Ryberg, P. Søgaard Jørgensen, P. Villarrubia-Gómez, Z. Wang, and M. Zwicky Hauschild,
Outside the Safe Operating Space of the Planetary Boundary for Novel Entities, 2022.
23
Examples include negative effects on pollinators, insects, aquatic ecosystems and bird populations.
24
European Environment agency, Chemical risk estimates, 2019. Adapted from Malaj et al, 2014. Organic chemicals
jeopardize the health of freshwater ecosystems on the continental scale. Organic chemicals were likely to exert acute
lethal and chronic long-term effects on 14 to 42% of over 4000 monitored sites.
25
Eurostat, Eurobarometer, 2020.
8
Table 1: Problem tree
A functional internal market for chemicals delivering a sub-optimal protection of human health
or the environment
Problems
Hazardous chemicals are
not comprehensively
identified and classified
D1. Missing provisions for identification of critical hazards
Regulatory/administrative
drivers
D2. Inefficient procedures for hazard assessment and
classification
Sub-optimal
communication on
chemical hazards
D3. Complexity of some labelling provisions
D4. Some chemicals are not labelled according to CLP
D5. Current labelling rules do not sufficiently exploit new digital
tools
High level of non-
compliance (online sales
and poison centres)
D6. Rules are inadequate to keep pace with new means of sale
D7. Unclear provisions on notifications to poison centres
The chemicals Fitness Check found that the EU’s regulatory framework on chemicals does not
allow a complete and consistent identification and classification of chemical hazards. The main
issues concern the identification of the most critical hazards, and the overall quality of the
information on the substances that have been identified and classified.
2.1.1.1 Most critical hazards
Over the last 15 years, scientists have raised particular concerns on the following hazards:
 Endocrine disrupting (ED) properties have been the focus of increasing scientific
research, and the accumulated knowledge identifies EDs as a concern to public and wildlife
health26,27
. The high and increasing incidence of many endocrine-related disorders in
humans – such as asthma, birth defects, neurodevelopmental disorders, cancer, diabetes and
obesity in children or adults – have important parallels in some wildlife populations. Some
links have become apparent (e.g. polychlorinated biphenyls’ exposure as a risk factor in
breast and prostate cancers) while more research is necessary on the associations between
EDs and other endocrine-related diseases17,28
.
 Substances with persistent, bioaccumulative and toxic (PBT) and very persistent, very
bioaccumulative (vPvB) properties do not easily break down in the environment and tend
to accumulate in living organisms across the food web. Experience has shown that the
accumulation of these substances in the environment is difficult to reverse, as cessation of
emission does not readily result in lowering their concentration, and the effects of this
accumulation are unpredictable in the long-term. Moreover, PBT/vPvB substances have the
potential to contaminate remote pristine areas. They also pose particular challenges to the
26
United Nations Environment Programme, State of the Science of Endocrine Disputing Chemicals - IPCP-2012.
27
L.N. Vandenberg & J.L. Turgeon, Endocrine disrupting chemicals: Understanding what matters. In L. N.
Vandenberg, & J. L. Turgeon (Eds.), Endocrine-Disrupting Chemicals, 2021.
28
Kahn et al., Endocrine-disrupting chemicals: implications for human health, The Lancet. Diabetes & endocrinology,
8(8), 703–718, 2020.
9
reliability of quantitative risk assessment, as a safe concentration in the environment cannot
be established with the available methodologies29
.
 Substances with persistent, mobile and toxic and very persistent, very mobile
(PMT/vPvM) properties pose grave concerns because they can enter the water cycle,
including drinking water, and spread over long distances, making the determination of their
impacts very challenging30
. Many PMT/vPvM substances are only partly removed by
wastewater treatment processes and can even break through the most advanced purification
processes at drinking water treatment facilities. Their incomplete removal coupled with
ongoing emissions means that their concentrations in the environment increase over time.
CLP currently does not oblige manufacturers to identify those intrinsic properties. Substances with
ED, PBT/vPvB properties are only identified through REACH on an ad-hoc basis and through the
pesticide and biocide regulations. Substances with PMT/vPvM are only identified via REACH. The
identification criteria in EU legislation are not harmonised (see driver 2.2.1 and Annex 8).
Therefore, manufacturers only have to identify ED, PBT/vPvB and PMT/vPvM properties for
REACH-registered substances, and not for other substances. Several Member States31
, the
European Parliament and NGOs32
have frequently called for addressing those hazards coherently at
EU level, and some Member States are taking individual actions on one or more of these hazards.
Different national criteria for the missing hazard classes would seriously impair the current well-
functioning single market for chemicals.
Consequences
According to ECHA, only 67 substances have ED, PBT/vPvB and PMT/vPvM properties
confirmed under REACH (see Table 2 and Annex 8) since 2008 and 1,113 are under assessment.
This is in contrast with the minimum of 1,650 substances that, according to ECHA estimates, could
have one of the three hazard properties.
Table 2: Number of substances identified, in the process of being identified or candidates for ED, PBT, PMT, vPvB,
vPvM hazards (ECHA: registered substances under REACH, 2021. See Annexes 4 and 8).
Already identified Under assessment Possible candidates
ED HH & ENV** 24 434 1,012
PBT and vPvB 34 324 396
PMT and vPvM 9 355 231
*ECHA’s guestimates (subject to very high uncertainty) on how many substances could have the same hazard(s) among the
remaining REACH registered substances ** ED category 1 only
Consumers and workers are widely exposed to those chemicals33
in particular through consumer
products (e.g., toys, food contact materials, cosmetics, furniture, textiles, etc.) or during
29
Guidance on the Application of the CLP Criteria. Guidance to Regulation (EC) No 1272/2008 on classification,
labelling and packaging (CLP) of substances and mixtures. ECHA-17-G-21-EN. Version 5.0 – July 2017. European
Chemicals Agency, 2017.
30
Hale et al., Persistent, mobile and toxic (PMT) and very persistent and very mobile (vPvM) substances pose an
equivalent level of concern to persistent, bioaccumulative and toxic (PBT) and very persistent and very
bioaccumulative (vPvB) substances under REACH, Environ Sci Eur 32, 155, 2020.
31
Five Member States (Belgium, Denmark, France, The Netherlands and Sweden) launched a website in June 2020
having the aim of informing stakeholders about the current status of substances identified as EDs to increase the
knowledge base on them. Those Member States call for action at EU level. France already adopted a decree on ED
identification (Article L541-9-1 of the French Public Health Code).
32
Chemical Watch, “NGO coalition urges EU Commission to publish EDC Strategy”.
33
In 2022, an analysis of the registration dossiers looked at uses mentioned in dossiers for substances identified as
candidates for the new hazard classes. Paints, adhesives, washing and cleaning products and inks and toners are
10
professional uses. Release of those substances into the environment during their use phase or at end
of life disposal can have long-term and large-scale environmental impacts on terrestrial and marine
environment.
It is not possible to quantify fully the impact on human health and the environment of chemicals
with the most critical hazards. However, exposure to certain EDs has been associated to IQ loss and
intellectual deficiencies with a probability of causation of 70% to 100%, with moderate to high
strength of human evidence. EDs are also suspected to cause male infertility, obesity, diabetes and
other health issues with varying probabilities of causation and strength of human evidence34
.
Researchers estimated that exposure to EDs leads to substantial health-related societal costs
between 46 and 288 billion Euro per year35
(see also Annex 8). Persistent chemicals do not break
down in the natural environment. The risk is that concentrations will build up in nature such that
levels of exposures to humans and other biota are irreversible. Some 3.5 million sites around
Europe are already contaminated by hazardous and persistent substances. Contamination of natural
resources has severe economic consequences, ranging from the extremely high costs of remediation
to loss of natural resources such as drinking water, land, soils and fish stocks from productive use36
.
2.1.1.2 Quality of information on classified substances
The chemicals Fitness Check also highlighted a particularly high number of incorrect or obsolete
classifications of substances as well as diverging classifications for the same substance in the
CLP classification and labelling inventory. In 2017, 59% of companies had multiple notified
classifications for a single substance37
. Companies also reported their difficulties to notify or update
their notification on the substances they self-classify. The current process was overall assessed as
bringing excessive costs and administrative burden, with companies - especially SMEs - needing
specific trainings or to sub-contract tasks due to the complexity of the procedures and/or the lack of
user-friendly IT tools8
. More recently, ECHA concluded that the situation on diverging
classifications had improved, as, in 2021, 78.4% of the 205,900 notified substances have only one
self-classification38
(see Figure 3).
respectively the 3rd
, 4th
, 5th
and 6th
most frequently reported uses. VVA et al, 2022, Background document – Workshop
on the extension of the generic approach to risk management under the REACH regulation (21 March 2022).
34
Kahn, L. G., Philippat, C., Nakayama, S. F., Slama, R., & Trasande, L. (2020): Endocrine-disrupting chemicals:
implications for human health. The Lancet. Diabetes & endocrinology, 8(8), 703–718. https://doi.org/10.1016/S2213-
8587(20)30129-7
35
I. Rijk, M. van Duursen, and M. van den Berg, Health cost that may be associated with Endocrine Disrupting
Chemicals — An inventory, evaluation and way forward to assess the potential health impact of EDC-associated health
effects in the EU, Institute for Risk Assessment Sciences, University of Utrecht, 2016.
36
European Commission, Study for the Strategy for the Non-Toxic Environment, p. 123.
37
Amec Foster Wheeler et al., A Study to gather insights on the drivers, barriers, costs and benefits for updating
REACH registration and CLP notification dossiers, 2017.
38
ECHA’s presentation at ad-hoc CARACAL of 14 December 2021.
11
Consequences
Missing, incomplete and/or incorrect hazard identification and characterisation of chemicals leads
to incomplete information for users of chemicals, which may increase their exposure to those
chemicals. Furthermore, with hazard identification under CLP as the starting point for product
specific risk assessments (e.g., for cosmetic products) and assessments under REACH, companies
and authorities may not be able to set adequate risk management measures. This leads to an
insufficient level of protection of consumers, workers and the environment, and causes the
inefficient use of resources for authorities and companies who are forced to act with sub-optimal
information or simply cannot take any action. Especially SMEs rely on hazard identification data
for their chemicals classification. Moreover, incorrect data hampers competition between the
businesses that identify correctly and those who do not.
2.1.2 Sub-optimal communication on chemical hazards
Labels are the primary means of communication to inform consumers and workers about the
hazards of the chemicals they purchase, use or dispose. The specification of those labels is provided
by CLP (see pictograms in Figure 4). A Eurobarometer survey in 201639
found that, while 70% of
EU citizens find information on the hazards of chemicals on the label useful, only 45% of the
respondents feel well informed about the potential dangers of the chemicals contained in
consumer products. Respondents in particular felt that they had a relatively low level of
understanding of certain pictograms, labels and precautionary statements on chemicals, especially
due to limited readability of labels due to extended amount of information, the technical language
and to the often too small font size. Consumer understanding of chemical labels is also very
heterogeneous across Europe, with Northern Europeans reported feeling more informed compared
with Southern Europeans. Understanding also varies between consumers and professional and
industrial workers, as professional and industrial workers are generally trained to understand the
information on the safety label. In the framework of this impact assessment, it is possible to broadly
estimate an average level of 55% EU citizens considering not to be well informed about the
potential dangers of the chemicals contained in consumer products (see Annex 12).
39
Special Eurobarometer 456, 2017.
Figure 3: Diverging notified classifications per notified substances (left) or per notifications (right)
12
Secondly, complex and overloaded labels bring along also high compliance costs for industry,
especially SMEs40
. Ambiguous or difficult rules to apply in practice are not evenly implemented by
companies or enforced between the Member States, hence hampering the level playing field (see
also under 2.1.3. below). Feedback from the open public consultation showed that current labelling
exemptions under CLP do not always provide practical solutions for an effective hazard
communication via labelling and that simplification may be possible whilst providing the same or
even better level of safety41
. Most respondents considered that significant savings can be achieved
by exempting certain very small products42
(e.g. writing instruments) and certain chemicals sold in
bulk to consumers (e.g. fuels), by extending the scope of fold-out labels and by introducing digital
labelling43
.
Figure 4: Pictograms provided by CLP
Finally, for some categories of products, which are exempted from the scope of CLP – cosmetics,
human and veterinary medicinal products, medical devices and food and feed stuff –, the
communication to consumers on the environmental hazards of the substances present in those
products is sub-optimal (see Annex 14). These products are exempted, based on the premise that
the exempted sectorial legislations lay down more specific rules on classification and labelling.
While for medicinal products and medical devices, warnings and use instructions to users may
cover environmental hazards, these hazards are not addressed in the legislation concerning cosmetic
products. Literature provides evidence that some of the exempted products (e.g., pharmaceuticals or
rinse-off cosmetic products and sunscreens) and their ingredients (e.g., plastic microbeads,
siloxanes, or UV filters) end up in the environment in significant quantities where they may cause
damage to the aquatic environment 44,45,46
. An ongoing study47
also identified hazardous substances
reaching urban wastewater treatment plants and linked their release to pharmaceuticals and personal
care products amongst other products. However, the supporting study did not directly identify CLP
labelling as having an impact on consumer behaviour. Also, several relevant initiatives (e.g. the
Proposal for Ecodesign for Sustainable Products Regulation, the revision of the Cosmetic Products
Regulation, industry self-standards, see Annex 14) are currently under way and may significantly
change the availability of information of environmental impacts, as well as the impact itself, of the
40
SWD to the chemicals Fitness Check, p.62. The chemicals Fitness Check estimated that the average cost of
redesigning and modifying labels to be compliant with CLP was €388 per substance and €475 per mixture.
41
Summary in CARACAL CA/11/2021.
42
Where the inner packaging of products contain up to 10ml of chemicals.
43
Certain chemical industries, in particular the detergents industry, face a relatively high administrative burden to
comply with labelling requirements and hence more innovative communication approaches to labelling could be
explored; Annex 2 and 13.
44
N.A. Vita, C.A. Brohem, A. D. P. M. Canavez, C. F. S. Oliveira, O. Kruger, M. Lorencini & C.M. Carvalho,
Parameters for assessing the aquatic environmental impact of cosmetic products, Toxicology letters, 287, 70-82, 2018.
45
S. Bom, J. Jorge, H.M. Ribeiro & J. Marto, A step forward on sustainability in the cosmetics industry: A review,
Journal of Cleaner Production, 225, 270-290, 2019.
46
C. Juliano and G.A. Magrini, Cosmetic Ingredients as Emerging Pollutants of Environmental and Health Concern. A
Mini-Review, Cosmetics, 4, 11-29, 2017.
47
Wood, Study supporting the Evaluation of Directive 91/271/EEC concerning urban waste water treatment, 2019.
13
exempted products. Therefore, this problem cannot be adequately addressed through this revision.
Follow up discussions will continue with all relevant actors and more evidence would be needed.
Consequences
Sub-optimal communication on chemicals may hamper consumers’ ability of making informed
choices and can lead to the inappropriate use of chemicals, harming their health as well as the
environment. Considering the increasing interest of consumers in the environmental impact of the
products they buy48
, sub-optimal communication on environmental hazards limits their ability to
lower their environmental footprint and, thereby, contribute to the EU Green Deal’s goal of
sustainable consumption.49
Unnecessarily complex or ambiguous labelling provisions also lead to
avoidable compliance costs by companies and an uneven level playing field due to different
implementation by companies and enforcement by Member States (see also under 2.1.3. below).
2.1.3 High level of non-compliance (online sales and poison centres)
Imported chemicals and online sales represent a particular challenge and the Chemicals
Strategy for Sustainability identifies them as a priority area for action50
. Almost 30% of the alerts
on dangerous products on the market involve risks due to chemicals, with almost 90% of those
products coming from outside the EU51
. Many products that are sold online in the EU but
manufactured outside the EU do not meet the EU product safety and chemical legislation
requirements52
. The volume of online sales is expected to grow, hence increasing the problem. A
study on cross-border online sales observed a 14.4% increase in e-commerce revenues in 2019
compared to 201853
. Business models and intermediary services that did not yet exist in 2008 - e.g.
social media, online marketplaces - nowadays connect online sellers and buyers worldwide54
.
48
Megatrends, Supporting policy with scientific evidence, Consumers wish to be increasingly aware of the
environmental performance of the products they buy; see megatrends in sustainable consumption.
49
The European Green Deal sets the ambition to empower consumers to make informed purchase choices and play an
active role in the ecological transition.
50
COM(2020) 667, p 17.
51
RAPEX web reports.
52
KEMI, Increased e-commerce – increased chemicals risks? A mapping of the challenges of e-commerce and
proposed measures. Report of a government assignment, 2021.
53
Cross-Border Commerce Europe (2020): Cross-Border Commerce Europe publishes the second edition of the “Top
500 cross-border retail Europe”: an annual ranking of the best 500 European cross-border online shops. Other
estimations show an increase of 1.1% between online sales from 2020 to 2021 and thus it can be expected that the
number of non-compliant items sold will increase over time unless action is taken.
14
Figure 5: Imported goods in the EU based
on product amounts
Non-compliance with the provisions of CLP on online advertisement very frequent, especially
for chemicals sold online, both by EU and non-EU actors. International research projects49

found that the rate of non-compliance with CLP provisions was 75% of 2,752 inspected products in
29 EEA countries and 82.4% of 1,314 inspected products in 15 EU countries54
. Based on
estimations, non-compliances of non-EU sellers with CLP are higher than those of EU sellers in
relative terms55
, and amount to yearly 7.3 million non-compliant products sold directly from non-
EU actors to consumers (see Annex 15). A specific issue in terms of implementation relates to
notifications that businesses have to submit to poison centres for emergency health response.
Poison centres across the EU answer over half a million calls for support per year56
, therefore, it is
essential that they have all the necessary information on e.g. the composition of mixtures in order to
provide the appropriate advice to consumers or health carers. Although notifications significantly
improved over the years for trade within Member States and imported chemicals, there are still two
situations where implementation is sub-optimal as businesses fail to notify: in the case of intra-EU
cross-border trade and/or re-branding/re-labelling. The estimation of mixtures currently not notified
under those two scenarios is between 252,500 – 637,500 out of a total of 1.4 million mixtures
notified in 2021 (see Annex 16).
Consequences
As a result of the issues described above, consumers and workers are often confronted with
chemicals with no or incorrect labelling and packaging, in particular when buying online directly
from non-EU sellers (and to a lesser extent when buying from intra-EU sellers). As online offers
and advertisements often do not display hazardous information, consumers may not be able to make
informed choices, or correctly use, store or dispose of mislabelled chemicals such as detergents or
paints, leading to risks for their health and/or the environment. Furthermore, the lack of compliance
with or enforcement of CLP rules for imports also leads to an uneven level playing field, including
a competitive advantage of non-EU actors operating online compared to EU actors – such as
importers, downstream users, distributors and manufacturers - who must comply with CLP
(especially of SMEs who merely operate within Europe). Finally, the lack of the submission of
correct emergency health response information to poison centres leads to insufficient health
54
Non-compliant with Article 48(2) on advertisement of mixtures, ECHA, Final report on the Forum Pilot Project on
CLP focusing on control of internet sales, 2018.
55
For CLP the suggestion is 1.37 times higher.
56
European Commission’s webpage on https://ec.europa.eu/growth/sectors/chemicals/poison-centres_en.
15
responses or patients’ overtreatment57
(see Annex 16) as well as an uneven level playing field for
businesses who correctly submit the correct emergency health response information. This affects
their competitiveness compared to non-compliant companies58
.
2.2 The problem drivers
The problem and its manifestations are driven by several regulatory failures.
2.2.1 Missing provisions for the identification of critical hazards
CLP provides that, for hazards of highest concern, classification and labelling of substances should
be harmonised throughout the EU. However, the hazards currently defined under CLP — the same
defined under (UN) Globally Harmonized System (GHS) — are not exhaustive and horizontal
identification criteria and hazard classes are missing for some of the most critical hazards, in
particular EDs, PBT and vPvB, PMT and vPvM. While identification criteria do not yet exist in EU
legislation for PMT/vPvM substances, some criteria and provisions to identify EDs and PBT/vPvB
exist in some pieces of EU legislation (e.g. the Plant Protection Products Regulation59
and the
Biocidal products Regulation60
) or as an international standard61
(Annex 8 provides more details on
the gaps and inconsistencies in the regulatory framework). However, a horizontal and systematic
approach to identification is still missing across EU legislation62
(see Annex 5). The lack of
horizontal criteria for EDs was already identified as a priority area for action in the EU's 7th
Environmental Action Plan as well as in the Fitness Check on endocrine disruptors, and the lack of
progress has been regularly criticised, including by the European Parliament and the Council (see
Annex 2).
2.2.2 Inefficient procedures for hazard characterisation and classification
The Chemicals Fitness Check and the study conducted for this impact assessment have evaluated
the performance of the procedures to classify chemicals hazards, both via harmonised classification
as well as industry’s self-classification. It concluded that classification procedures are not fully
efficient, and that there is room for improvement both in terms of speed of the processes as well as
in terms of reduction of administrative burden for authorities and companies. Stakeholders also
confirmed that improvements would be beneficial8
.
Almost all dossiers for harmonised classification are developed by Member States63
. The situation
reported in the chemicals Fitness Check reflects the amount of resources needed at Member State
level – in terms of staff as well as expert capacity - for preparing a classification dossier, combined
with reductions in resources and budgets allocated for this work. Considerable variation exists
between Member States in their capacity and willingness to initiate harmonised classification
57
According to the chemicals Fitness Check, hospitalisation costs amount from €960 to €15,600 for severe accidents.
58
Currently 252,500 – 637,500 mixtures are not notified; assessments how much such legal ambiguities would affect
competitiveness is not known.
59
Regulation (EC) No 1107/2009.
60
Regulation (EU) No 528/2012.
61
such as the World Health Organisation (WHO) definition for EDs
62
For example, there are 22,930 registered substances in 101,787 dossiers and 212,425 notified substances in the
Classification and Labelling Inventory.
63
Manufacturers, importers and downstream users are also entitled to submit harmonised classification and labelling
dossiers in certain cases.
16
dossiers, with just about half of them carrying most of the burden64
. It is also understood that the
committee65
assessing proposed harmonised classification currently operates at its maximum
capacity, with some 60 opinions delivered per year (see Annex 10). Interviewed stakeholders
respondents also noted the lack of a prioritisation of substances for classification and some
competent authorities highlighted the lack of adequate resources in ECHA for classification
processes.
The main weaknesses of the self-classification processes relate to its capacity to ensure convergent
and updated information on the substances self-classified by industry and included in the CLP
inventory maintained by ECHA. The divergence seems to be due to different elements intrinsic to
the process. First, there is currently no legal requirement for notifiers to come to an agreement on
self-classifications, only an obligation to ‘make every effort’. The lack of transparency in the CLP
inventory regarding the identity of notifiers also prevents communication between notifiers of the
same substance, creating an additional barrier66
. ECHA has recognised the issue of incorrect,
diverging, or obsolete information in the inventory for some time67
and has developed a process to
encourage notifiers to communicate with one another in an effort to increase convergence.
Although the process68
has helped to improve the correctness of information in the inventory, there
are hardly any incentives for agreeing on classifications after notifications are submitted to the
inventory.
Finally, diverging reference values for a substance come from the absence of a harmonised
methodology69
or different toxicity data sets (see Annex 9). For the purpose of harmonising the
safety assessment of chemicals, including methodologies and reference values, the Chemicals
Strategy for Sustainability also envisages a ‘One substance, one assessment’ process (see also
baseline in 5.1.).
2.2.3 Complexity of some labelling provisions
The chemicals Fitness Check shows that the complexity of the CLP labelling rules results in
unsatisfactory implementation by companies, in particular SMEs, as well as high level of non-
compliance on labelling.70
The general labelling requirements can become even more complex
when multiple pieces of legislation apply. In addition, there are some exemptions from the CLP
labelling rules due to the practical constraints triggered by e.g. the size, shape or type of the
packaging which can also induce complexity and have proven difficult to apply in practice. This
complexity is also reflected in the relatively high level of non-compliance with CLP labelling
requirements, which was found to range from 33.5% to 71%71
,72
in particular for chemicals placed
64
ECHA, Transparent progress in addressing substances of concern. Integrated Regulatory Strategy annual report,
2021.
65
The Risk Assessment Committee is composed of 45 experts from Member States and 5 co-opted ones appointing
intuitu personae. They perform amongst other tasks the EU peer-review of proposed harmonised classification.
66
CARACAL Document CA/77/2020 described ways to improve and re-design the CLP inventory to address some of
the difficulties faced by the notifiers.
67
ECHA, C&L inventory: convergence in self-classification ppt. CARACAL – 17 - 26th March 2015, 2015.
68
ECHA, How to prepare a classification and labelling notification, October 2021
69
Such as Derived No-Effect Levels (DNELs) or Predicted No–Effect Concentrations (PNECs). Diverging human and
environmental reference values, have been identified in different REACH registration dossiers for a substance.
70
Implementation complexity includes the specific labelling derogations applicable to certain products laid down in
section 1.3. of Annex I of CLP.
71
ECHA, REF-6 project report - Classification and labelling of mixtures, 2019.
72
ECHA REF-8 project report on enforcement of CLP, REACH and BPR duties related to substances, mixtures and
articles sold online, 2021.
17
on the market for refill (e.g., detergents), or chemicals with very small packaging (e.g., pens), or
sold in bulk to consumers (e.g., fuel at filling stations)8
.
2.2.4 Current labelling rules do not sufficiently exploit new digital tools
Since the entry into force of the CLP, digitalisation has led to the development of new labelling
technologies which are not adequately captured by the current scope of the regulatory framework.
The chemicals Fitness check already pointed out that the existing CLP provisions and requirements
on labelling do not consider the opportunities offered by digitalisation, which could help reach
consumers more effectively and reduce compliance costs for companies73
. In particular, no mention
is made in CLP of the possibility to use digital labelling solutions to improve hazard
communication and other relevant pieces of information to users of chemicals (see Annex 13).
2.2.5 Rules are inadequate to keep pace with new sales channels
CLP has not sufficiently been adapted to some current societal and technological trends such as the
increase in online sales (see 2.1.3). CLP does not apply to non-EU based economic actors, who can
today more easily than in the past reach and sell directly to consumers in the EU. CLP does not
consider situations in which consumers become de facto and de jure importers as they buy online
directly from non-EU economic operators. In addition, the CLP is very ambiguous about online
offers, online advertisements, the obligation to display labelling information in online offers and to
mention certain hazard information (see Annex 15).
2.2.6 Unclear provisions on notifications to poison centres
CLP provides the obligation to downstream users and importers to submit relevant information for
emergency health response – but not to distributors or any other suppliers placing mixtures on the
market. This loophole leads to information loss for poison centres in two cases. Firstly, in the case
of cross-border distribution within the EU: if a distributor purchases a product in one Member State
and sells it in another, e.g., in the cases of intra-EU trade (no imports from outside the EU
involved). Secondly, in the case of re-branding/re-labelling: if the original supplier or a downstream
supplier places the mixture on the market in the same Member State but then re-brands or re-labels
it74
. Consulted stakeholders raised the issue of diverging interpretations of duty holders who are
obliged to submit poison centres notifications. An ad-hoc meeting of the expert group of Competent
Authorities for REACH and CLP also highlighted these differences75
.
2.3 How likely is the problem to persist?
Without any policy intervention (soft or hard law measures), the problems will subsist or worsen,
especially in light of current trends in the production and consumption of chemicals and products
(see also section 5.1.3).
73
SWD(2019) 199.
74
E.g., the estimation of currently not notified mixtures falling under those two scenarios is between 101,000 - 255,000.
75
The appointed bodies of four Member States agreed that there should be greater clarity on the inclusion of re-
branders/re-labellers and (other) distributors. However, the appointed bodies of other three Member States stated that
they already consider re-branders/re-labellers as downstream users whereas other Member States apply the proposed
interpretation of ECHA that distributors should comply with and in certain cases notify by virtue of Art. 4(10) so that in
practice the problem is solved. Ad-hoc Meeting of the CAs for the REACH and CLP Regulations (CARACAL) on
Annex VIII. Available at: https://circabc.europa.eu/ui/group/a0b483a2-4c05-4058-addf-
2a4de71b9a98/library/9872d680-66c6-4f01-ba97-942980734fb0/details
18
2.3.1 Hazardous chemicals are not comprehensively identified and classified
Without policy intervention, the identification of EDs, PBT/vPvB will continue to be done
differently across plant protection and biocidal products legislation, and REACH. It is also likely
that Member States will address concerns from emerging hazards individually. PBT/vPvB,
PMT/vPvM, and ED substances will continue to be identified under REACH on a case-by-case
basis76
. However, the pace of identification will remain largely dependent on the resources
allocated for the process to identify substances of very high concern, and on the follow up
processes to fill information gaps which can often take up to several years77
. A systematic
assessment of PBT/vPvB will be limited to substances above 10 tonnes/year under REACH
representing only 50% of the registered substances78
and only 5% of the substances notified in the
CLP classification and labelling inventory. At the end of 2020, there were around 1,860 substances
of potential concern needing further data generation, an increase of approximately 20% compared
to 2019.
The number of chemicals identified as needing a (revision of their) harmonised classification
increased over the last years79
. The trend is expected to continue (see Annex 10) following more
thorough checks by ECHA and the rolling out of other actions under the Chemicals Strategy for
Sustainability, such as more knowledge being generated on registered substances.
Furthermore, other future actions identified in the European Green Deal and the Chemicals Strategy
for Sustainability will trigger additional regulatory actions and risk management measures for
critically hazardous chemicals in downstream regulations. Such measures would be based on
harmonised classification. Moreover, the number of diverging self-classifications is also likely to
persist and even increase due to the addition of new hazard classes.
2.3.2 Sub-optimal communication on chemical hazards
Problems related to complex and impractical labelling requirements, will remain very significant
at EU level or get worse. Although appropriate guidance how to implement those provisions in the
CLP already exists80
, it will not entirely solve the problem. For example, by 2040 it is expected that
the market for refill chemicals will increase up to over 265,000 t/year and that between 6.62 and
66.2 million purchases of refill chemicals may happen without appropriate labelling in the absence
of policy intervention. Also, labelling issues with chemicals placed on the market in very small
packaging (e.g. writing instruments, lighters, essential oils) are expected to remain due to an
estimated slight increase of the number of those products placed on the market by 204081
. The trend
of consumers wanting to know the environmental impact of chemicals is also expected to continue,
as part of the overall megatrends on consumers’ willingness in making more informed sustainable
purchase choices82
. Moreover, digitalisation trends will continue and expand and the problem of
CLP not keeping adequate pace with technological solutions will aggregate and CLP risks of
missing out on remaining key instrument for consumers to make informed choices.
76
Via substances of very high concern (SVHC) identification.
77
ECHA, Transparent progress in addressing substances of concern. Integrated Regulatory Strategy annual report,
2021, pp.17-19.
78
See ECHA statistics on registration: 58c2d7bd-2173-4cb9-eb3b-a6bc14a6754b (europa.eu)
79
This number has been multiplied by 7 between 2018 and 2021.
80
ECHA guidance on labelling and packaging was first issued in 2011 and revised several times.
81
Those products are broadly commercialized and purchased in EU: between about 734 to 898 billion units are placed
on the EU market every year. See Annex 12.
82
Supporting policy with scientific evidence, Megatrends, Consumers wish to be increasingly aware of the
environmental performance of the products they buy; see megatrends in sustainable consumption.
19
2.3.3 High level of non-compliance
In future, safety of chemicals purchased online will be positively affected by new EU legislation
related to product safety, market surveillance, digital services and customs (see baseline 5.1.). The
Digital Services Act83
and the General Product Safety Regulation84
will significantly help solving
implementation or compliance problems on online sales related issues. They will, however, not
entirely solve issues of legal gaps or ambiguities specifically within CLP, especially when the
proportion of online sales and imported products is increasing (see baseline in 5.1.) and the
resources allocated by Member States for enforcement activities are not expected to increase
substantially.
For poison centres, the problem will slightly increase given that distributors are expected to sell
more across EU borders, and hence also re-branding. Due to legal ambiguities in CLP, some
distributors will continue arguing that the currently applicable provisions do not oblige them to
notify in certain cases where information to poison centres would be paramount.
3 WHY SHOULD THE EU ACT?
3.1 Legal basis
The EU has the right to act and maintains the same legal base in the revision as for the adoption of
the original act, Article 114 of the Treaty on the Functioning of the European Union (TFEU). This
revision entails further harmonisation of the internal market in the field of classification, labelling
and packaging of chemicals and will take as a basis a high level of health, safety, environmental,
and consumer protection. This revision takes into account other relevant provisions of the TFEU,
i.e. Titles XIV on Public Health, XV on Consumer Protection and XX on Environment.
Following Article 4(2) TFEU, the EU has shared competence in the policy areas of internal market,
environment, consumer protection and common safety concerns in public health matters. Therefore,
the subsidiarity principle applies. The EU’s compliance with the subsidiarity principle is ensured by
explaining why Union action is necessary and Member States’ actions are not enough to achieve
the set objectives, and through following the procedure under Protocol No 2 of the TFEU by
consulting national Parliaments widely.
3.2 Subsidiarity: Necessity of EU action
Measures at Union level to further improve classification, labelling and packaging of chemicals are
necessary and relevant to improve the achievement of the main objectives in the CLP Regulation:
ensure a high level of protection of human health and the environment as well as the free movement
of substances, mixtures and certain articles.
Action at Member States’ level or at a more local level to achieve those objectives is not enough for
the following reasons:
 Most problems (e.g., diseases and pollution through hazardous substances, insufficient
compliance) result in costs for society and the general public (negative externalities) and
their intensity may vary across the European regions, but they exist everywhere in the EU to
83
Proposal for a Regulation on a Single Market for Digital Services, COM(2020) 825 final.
84
Proposal for a Regulation on general product safety, COM(2021) 346 final.
20
a certain extent; to adopt a coherent approach tackling such problems, EU action is
necessary;
 Most problems are transboundary in nature, or even have an international dimension and
touch upon customs related matters, which cannot be sufficiently addressed by single
Member States in isolation. To further improve the free movement of substances and
mixtures and enable an even better functioning internal market, Member States cannot act
alone, they need an overarching framework regulating such movement;
 Apart from different enforcement levels in the Member States, the problem drivers are the
same (see list above), so that EU action addresses the problem drivers best;
 Certain Member States have already initiated national actions to fix missing hazard classes
before awaiting for any EU action on the matter; this could lead to the undesirable effect of
heavily fragmenting the internal market. Also, Member States’ behaviour would not seem to
be fully in line with the Treaty providing for the general principle that Member States shall
not exercise their competence if the Union did already (subsidiarity principle and TFEU on
the approximation of laws85
). EU action would hence make the overall system more
coherent.
3.3 Subsidiarity: Added value of EU action
One action at Union level will be less costly and more efficient than twenty-seven different actions
to solve the same problems (economies of scale exist), and therefore EU action brings added value.
CLP replaced different national policies harmonising the rules at EU level, which has proven to be
a success8
. EU action would aim at addressing the shortcomings of an already existing framework
which will help achieving the objectives of CLP.
4 OBJECTIVES: WHAT IS TO BE ACHIEVED?
4.1 General objectives
The general objective of this initiative is to ensure a well-functioning single market for chemicals
and a high level of protection of human health and of the environment from hazardous chemicals.
This initiative also aims at modernising and simplifying the classification and labelling of
hazardous chemicals - where this is feasible, e.g., through the opportunities offered by
digitalisation, and at eliminating unnecessary burdens (especially for SMEs) without undermining
the objectives and benefits of the legislation.
4.2 Specific objectives
The initiative should achieve, at the end of the 20-year period considered to identify the impacts,
three specific objectives detailed below linked to the three problems and their respective drivers:
4.2.1 Ensure that chemicals are classified adequately and in line with the severity of
their hazards
The first specific objective is to ensure that all chemical hazards are adequately identified and
characterised, through both harmonised classification and self-classification as well as through the
harmonisation of reference values. This would also allow streamlining hazard assessments currently
performed in other legislation86
. In particular, this initiative would aim at:
85
Article 2(2) TFEU.
86
like the Biocidal Product Regulation and the Plant Protection Products Regulation.
21
 Ensuring comprehensive identification and classification of EDs, PBT/vPvB, PMT/vPvM
substances and mixtures containing them;
 Increasing the number of substances with harmonised classification by 1/387
;
 Improving self-classification and the CLP classification and labelling inventory to achieve
agreed self-classification per substances, freeing the harmonised classification process for
substances with critical hazards and reducing the need to solve divergence via a harmonised
classification;
 Developing a scheme to harmonise and publish harmonised reference values for industrial
chemicals, where divergence is identified. CLP would not only cover hazard identification
but also hazard characterisation (see Figure 1).
4.2.2 Ensure comprehensive and comprehensible communication on chemical
hazards
The second specific objective is to ensure that information on hazardous chemicals placed on the
market is communicated to all market actors, in particular consumers, in a comprehensive and
comprehensible manner. This also includes the related objective of increasing consumer
understanding of CLP labels and, therefore, their awareness of the potential dangers of hazardous
chemicals and of the safety precautions to be followed. The achievement of this objective would be
measured by an increase of the percentage of EU citizens feeling well informed through CLP
labelling on the dangers of hazardous chemicals.
4.2.3 Address main legal gaps and ambiguities of CLP rules
The third specific objective is to ensure that all businesses fully apply CLP rules, in particular
where there is evidence on high non-compliance at the moment. This specifically concerns ensuring
that CLP labelling is shown in online offers and online advertising – including B2C online (offers
and) sales of chemicals – and ensuring that businesses submit the required emergency health
response information to poison centres.
The achievement of these objectives would be measured by:
 The reduction of non-compliance rates on online advertising and offering of chemicals;
 The reduction of the relative non-compliance rate between non-EU and EU sellers;
 The reduction of the overall non-compliance rate for all online sales;
 An increased number of correct emergency health submissions to the poison centres.
5 WHAT ARE THE AVAILABLE POLICY OPTIONS?
Table 3 presents an overview of the intervention logic, highlighting the link between identified
problems and drivers and suggested specific objectives and policy options.
87
This would cover both new harmonised classifications and updated ones.
22
5.1 What is the baseline from which options are assessed?
The baseline includes a brief description of the wider socioeconomic context, the evolution of the
macro-aggregates of the EU chemical industry and the assumptions on the continuation of the
existing legal framework and scope. A 20-year period (2023-2042) is considered adequate for the
projections under the baseline scenario and the impact assessment of the proposed options. Its
length has been decided in consideration of the expected time-span for the realisation of impacts,
especially for some adverse effects which only materialised in the (absence of) progeniture of
parents exposed to hazardous chemicals.
5.1.1 Socioeconomic context
Although growth in 2022 is set to be better than previously forecast, the outlook for 2023 is
significantly weaker for growth and higher for inflation compared to the European Commission's
Summer interim Forecast. Amid elevated uncertainty, high energy price pressures, erosion of
households' purchasing power, a weaker external environment and tighter financing conditions are
expected to tip the EU, the euro area and most Member States into recession in the last quarter of
the year. Still, the potent momentum from 2021 and strong growth in the first half of the year are
set to lift real GDP growth in 2022 as a whole to 3.3% in the EU (3.2% in the euro area) - well
above the 2.7% projected in the Summer Interim Forecast. As inflation erodes households'
disposable incomes, the contraction of economic activity is set to continue in the first quarter of
Table 3: Overview of the policy options and their link to identified problems and drivers
Problems Drivers Specific objectives Policy options
Hazardous
chemicals are
not
comprehensive
ly identified
and classified
D1. Missing provisions for
identification of critical
hazards
1. Ensure chemical
s are
classified adequatel
y and in line with
the severity of their
hazards
PO1a: New hazard classes
PO1b: Consistent self-classification and
improving transparency
D2. Inefficient procedures
for hazard assessment and
classification
PO1c: More and prioritised harmonised
classifications
PO1d: Complementing hazard
identification with hazard quantification
Sub-optimal
communicatio
n on chemical
hazards
D3. Complexity of some
labelling provisions 2. Ensure
comprehensive and
comprehensible
labelling on
chemical hazards
PO2a: Update/prepare guidance
D4. Some chemicals are not
labelled according to CLP
PO2b: Improving and making more
flexible existing labels
D5. Current labelling rules
do not sufficiently exploit
new digital tools
PO2c: Digital labelling
High level of
non-
compliance
(online sales
and poison
centres)
D6. Rules are inadequate to
keep pace with new means
of sale 3. Addressing main
legal gaps and
ambiguities
PO3a: Awareness campaigns
PO3b: Provisions and clear
responsibilities for online sales and
imports
D7. Unclear provisions on
notifications to poison
centres
PO3c: Clarifying provisions for
notifications to poison centres
23
2023. Growth is expected to return to Europe in spring, as inflation gradually relaxes. However,
economic activity is set to be subdued, with GDP growth reaching 0.3% in 2023 as a whole in both
the EU and the euro area. By 2024, economic growth is forecast to progressively regain traction,
averaging 1.6% in the EU and 1.5% in the euro area. The OECD long-term projections forecast the
GDP of the Euro Area (17 countries) to pass from USD2015 13.97 billion (EUR2015 12.59 billion) in
2020 to USD2015 18.65 billion (EUR2015 16.81 billion) in 2040 (33.5% growth)88,89
. There are signs
that this might be impacted by the Russian war in Ukraine and that this could lead to an inflation
increase, but figures are still uncertain.
On the social dimension, the EU27’s population is projected to increase from 447.7 million in
2020 and peak to 449.3 million in 2026, then gradually decrease to 446.8 million in 204088
. Both
the size and the proportion of older people in the total population are expected to increase89
, with
the share of the elderly (65 years and over) projected to grow from 21% in 2020 to 27% in 2040.
Increasing demographic imbalances90
, such as the ageing population, pose challenges for public
expenditure in relation to pensions, health care and long-term care costs.
At the same time, the acceleration of technological change and hyperconnectivity will also have
a strong influence on all aspects of human life in the next decades. The fifth generation of mobile
connectivity (5G), edge computing, next-generation batteries, precision sensors and quantum
computing will enable innovation, in particular towards human augmentation91
. This will empower
consumers to be better informed when they purchase or use hazardous chemicals thanks to, for
example, easier, faster, and more tailored information.
Finally, at the European but also global scale, climate change92 and environmental degradation93
are affecting human activities at multiple levels: degraded ecosystems are not longer able to provide
the services on which human life depend, such as food, availability of clean water94
.
5.1.2 The chemical industry
In 2020, the EU chemical production dropped by 1.9% compared to 2019 levels, but it is expected
to bounce back in 2021 (expected growth of 3%) and 2022 (2% growth). The long-term response of
the industry to the economic impacts of the COVID-19 pandemic remains uncertain. The EU share
of global sales continue to decrease (from 19.3% in 2010 to 14.4% in 2020, and projected to be
10.5% in 2030), but the global chemicals market is expected to keep growing markedly (from €3.5
trillion in 2020 to €6.2 trillion in 2030) resulting in an absolute growth of EU sales between 2020
and 2030 of around 30% (from €499.1 billion to €651 billion). The industry spent €9.4 billion in
88
Eurostat, Population on 1st January by age, sex and type of projection, 2021.
89
Eurostat, Population Projections in the EU, 2020.
90
Supporting policy with scientific evidence, Megatrends, Consumers wish to be increasingly aware of the
environmental performance of the products they buy; see megatrends in sustainable consumption (one of the 14 ‘long-
term global driving forces that are observable in the present and are likely to continue to have a significant influence for
a few decades’ — monitored by the European Commission for foresight exercises. The other 13 are: accelerating
technological change and hyperconnectivity, aggravating resource scarcity, changing nature of work, changing security
paradigm, climate change and environmental degradation, continuing urbanisation, diversification of education and
learning, widening inequalities, expanding influence of East and South, growing consumption, increasing demographic
imbalances, increasing influence of new governing systems, increasing significant migration, shifting health challenges.
91
Gartner, Human Augmentation, ‘Cognitive and physical improvements as an integral part of the human body’.
92
IPCC, 2022: Summary for Policymakers [H.-O. Pörtner, D.C. Roberts, E.S. Poloczanska, K. Mintenbeck, M. Tignor,
A. Alegría, M. Craig, S. Langsdorf, S. Löschke, V. Möller, A. Okem (eds.)]. In: Climate Change 2022: Impacts,
Adaptation, and Vulnerability.
93
EEA Report No 21/2019: Healthy environment, healthy lives.
94
EEA Report No 1/2020: Is Europe living within the limits of our planet?
24
research and innovation (around 7.4% of added value). The sector included around 57,000
companies contributing roughly to €309 billion in Gross Added Value and employing over 1.6
million people. Chemicals are used in all aspects of modern life, and virtually all manufacturing
sectors and many downstream sectors rely on chemical products, from agriculture to automotive
and aerospace. The industry generates over 3.6 million indirect jobs. SMEs account for 96.7% of
the number of enterprises in the chemical manufacturing sector and 16.1% of the total turnover95
.
5.1.3 Continuation of the existing legal framework and scope
As mentioned in section 2.3, the problems that have been identified are assumed to remain, if CLP
were to remain as it currently stands. On-going actions considered under the baseline include
updating existing guidance documents (e.g., on poison centres), improving IT platforms (e.g., IT
tools by ECHA on self-classification), encouraging voluntary improvements of the current
processes (e.g., to promote convergence of self-classifications) and enhancing market surveillance
(e.g. through ECHA Forum on enforcement). In addition, the following assumptions were adopted
to define the baseline (more details are provided in Annex 7):
Identification and classification of chemical hazards: Table 4 below summarises the estimated
number of substances and mixtures with ED, PBT/vPvB, PMT/vPvM properties that would be
identified by REACH or pesticide or biocide regulations via an ad hoc assessment performed by
competent authorities under the baseline. Discussions have started to complement REACH
information requirements in the area of endocrine disruption, broadening the amount of data
available to authorities, onto which CLP-classification would be based. Under REACH, this would
allow identifying more EDs as substances of very high concern (see section 5.1.4). The same
happens for PMT and vPvM substances96
.
Table 4: Estimated number of substances and mixtures with ED, PBT/vPvB, PMT/vPvM properties that would be
identified under the baseline
2022 2032 2042
Number of substances*
ED 13 210 290
PBT/vPvB 15 210 310
PMT/vPvM 7 70 110
Total 35 490 710
Number of mixtures**
ED 100 – 300 2,300 – 5,100 3,200 – 7,300
PBT/vPvB 200 – 400 2,400 – 5,300 3,400 – 7,700
PMT/vPvM 100 – 200 700 – 1,700 1,200 – 2,700
Total 400 – 900 5,300 – 12,200 7,800 – 17,700
Notes: *rounded to the nearest tens; **rounded to the nearest hundreds. As of March 2022, only 13 EDs, 15
PBT/vPvB and 7 PMT/vPvM SVHCs are still registered, and therefore on the market.
Hazard classification: The systematic and comprehensive identification and classification of EDs,
PBT/vPvB, PMT/vPvM imposed by the introduction of those hazard classes in CLP would increase
the number of identified substances and mixtures having ED, PBT/vPvB or PMT/vPvM properties.
The table below presents the estimate of the number of substances with harmonised classification
that could be expected in 2032 and 2042 without the new hazard classes. Plant protection and
biocide active substances would represent the largest share (see Annex 10):
95
Eurostat, PRODCOM, 2021
96
M. Neumann and I. Schliebner, Protecting the sources of our drinking water: The criteria for identifying persistent,
mobile and toxic (PMT) substances and very persistent and very mobile (vPvM) substances under EU Regulation
REACH (EC) No 1907/2006, Text 127/2019, Umweltbundesamt, 2019.
25
Table 5: Estimates of the number of harmonised classification and labelling substances in 2032 and 2042
2022 2032 2042
Linear forecast 4,385 4,450* 4,600*
Note: Value rounded to the nearest fifties
On self-classifications, divergence currently affects around 22% of notified substances. Also, 69%
of notifications diverge, but this figure is reduced to 23% once the agreement within group
notifications – where one company notifies on behalf of others - is taken into account. The situation
is believed to stay the same over the period under consideration. To be also noted that ECHA and
the European Commission initiated a redesign of the CLP classification and labelling inventory in
2019 (see Annex 11), with the aim to improve how data are displayed, structured and overall
improve its ease of use. The re-design is expected to be launched by 2023 but, although it is
expected to increase transparency, it will not directly address the drivers of diverging
classifications.
Types of chemicals with (most) labelling issues: Chemicals placed on the market for self-refill
(mostly detergents and home care products) account for about 179,000 t/year and they are estimated
to concern a range of 8.95 million to 89.5 million individual sales per year. By 2040 it is expected
that this practice will increase up to over 265,000 t/year accounting for about 13.25 million to 132.5
million individual sales per year for self-refill chemicals. Chemicals placed on the market in bulk
concern mostly fuel for transportation purposes purchased at fuel stations. Currently over 235,578
Kt per year of fuel are placed on the EU market. By 2040, this is expected to decrease to less than
100,000 Kt per year (due mostly to the development of electric cars). For chemicals placed on the
market in very small packaging (e.g. writing instruments, lighters, essential oils), between about
734 to 898 billion units are placed on the EU market every year. By 2040, this number is expected
to slightly increase, with an estimate from 367 up to 449 billion units.
Online sales: Online sales and their revenues are fast increasing year by year97
. Based on
estimations for 2021, instances of non-compliance related to chemicals sold online are high both for
EU and non-EU sales, but relatively higher for non-EU sales98
. Based on estimations, 16.6 million
out of 111 million (EU sales), compared to 7.3 million out of 32.4 million (non-EU sales) of
cleaning products or personal hygiene products were not CLP compliant in 202199
. Horizontal
ongoing EU initiatives – i.e. the proposal for the Digital Services Act100
, draft General Product
Safety Regulation101
, together with the Market Surveillance Regulation102
, and Consumer Rights
Directive103
- will partially address some of the problems. Therefore, the baseline is dynamic and
non-compliance rates may decrease in the years to come, but the decrease is difficult to estimate.
Poison centres: the baseline is the currently applicable regulatory framework, i.e., obligations for
duty holders104
and clarifications of those obligations enshrined in ECHA guidance. Based on
estimates, intra-EU distributors place between 220,000 – 560,000 products per year on another
Member State’s market and re-branders/re-labellers place between 32,500 and 77,500 products on
their Member State’s market, which amounts to a total between 252,500 – 637,500 cross-border or
97
See Annex 13 and section 2.1.3.
98
1.37 times higher, see Annex 13.
99
Annex 13.
100
Proposal for a Regulation on a Single Market for Digital Services, COM(2020) 825 final.
101
Proposal for a Regulation on general product safety, COM(2021) 346 final.
102
Regulation 2019/1020, OJ L 169, p. 1.
103
Directive 2011/83/EU, OJ L 304, p. 64.
104
Obligations by downstream users and importers as per Article 45, by distributers and other supplier types as per
Article 4(10)
26
re-branded/re-labelled distributed products. Based on estimates, 50% of those products are
currently notified thanks to distributors adhering to other CLP provisions105
. It can be assumed as
well that not all distributors change their product portfolio each year, so that the number of non-
notified mixtures is smaller than the 50% left.
5.1.4 Other policy developments
Several policy developments in interconnected areas and legislation will influence the evolution of
the problem, making it in some cases more pronounced, while in others contributing to address it
through complementary measures:
 The ongoing revisions of REACH and product legislation (e.g., cosmetics, toys, food
contact materials): on the side of data available which classification processes could use,
REACH is assessing a possible extension of data requirements for ED identification and for
substances placed in lower volumes. This means more information on ED hazard will be
available for adequate classification during the period considered in this impact assessment.
On the side of risk management, REACH and product legislation are under revision to adapt
their generic risk management which relies on harmonised classification as a starting basis.
Some legislation based on pre-market authorisations may also depend on harmonised
classification in the way plant protection products and biocides legislation do. Those
revisions will very likely increase the reliance on harmonised classification for the most
critical hazards, so that appropriate risk management measures can be adopted106
.
 The ‘One substance, one assessment’ process launched by the Chemicals Strategy for
Sustainability is providing a platform to improve harmonisation and ensure transparency of
the safety assessments of chemicals, including through a new horizontal legal proposal on
the transparency of chemical data and a common open data platform, including for reference
values. More data will be available to foster accurate harmonised and self-classifications
under CLP. Setting up CLP as the recipient for reference values would also harmonise this
step across regulations (see section 4.2.1 and Annex 5). Even if multiple sectorial
methodologies may still coexist, this would embody the part ‘one substance, ‘one hazard
assessment’ of this process.
 A number of policy initiatives coming from the European Green Deal will ensure that
consumers have access to updated information on the impact of consumer products on
human health and/or the environment. The Commission proposal for Ecodesign for
Sustainable Products Regulation107
introduces provisions to regulate consumer products on
a number of sustainability dimensions. The proposal also improves the provision of product
information via digital tools, in particular by a Digital Product Passport that will gather
data on a product and its value chain. This Passport is particularly relevant for the
introduction of digital labelling because it foresees the mandatory adoption of digital ways
of communicating product information. However, chemical safety is excluded from the
scope of this proposal. This means CLP should address the digitalisation of hazard
communication for chemicals. This would improve the efficiency of such communication
and adjust CLP to technological and societal changes.
105
Article 4(10) of CLP. See Annex 16.
106
Under CLP, the decision to classify a substance or a mixture is exclusively based on existing available information.
The need to generate any additional data requirements is regulated by REACH. Any impacts arising from that situation
will be assessed in the context of the revision of REACH.
107
Proposal for a Regulation of the European Parliament and of the Council establishing a framework for setting
ecodesign requirements for sustainable products and repealing Directive 2009/125/EC, COM(2022) 142 final.
27
 The on-going revision of the General Product Safety Directive108
and the proposal for the
Digital Services Act109
are part of the baseline for this impact assessment, as well as with
already applicable new pieces of legislation such as the Market Surveillance Regulation110
or the Consumer Rights Directive on distance contracts111
. These horizontal initiatives and
regulations will help addressing ambiguities related to online sales, but not solve the
problem outlined above entirely. Provisions on online marketplaces in draft General Product
Safety Regulation will apply to CLP and will help consumers to make informed choices
when they purchase chemicals online. However, the measures on mandatory economic actor
in the EU responsible for compliance, already introduced by Market Surveillance
Regulation and proposed by draft General Product Safety Regulation, do not cover CLP,
hence will not solve the problem of chemicals being sold directly to consumers from outside
EU via online sales. Therefore, it would be for CLP itself to address the problem of ensuring
chemicals sold from outside the EU are safe.
 On enforcement and compliance of chemicals and products legislation, the revision of
REACH is looking into ways to address shortcomings on a number of aspects related to
both CLP and REACH, as enforcement authorities cover in most cases both these two
regulations112
. The REACH revision will look in particular at establishing an Audit Capacity
to verify and strengthen the effectiveness of Member States’ control systems on chemicals,
the role and tasks of ECHA’s Forum on enforcement, interlinks on customs-related issues
and collaboration with customs authorities.
5.2 Description of the policy options
The policy options have been constructed by selecting from a comprehensive list of potential policy
measures based on the evaluations of the existing legislation and on the input received from
stakeholders (see Annexes 8 to 16 for more details). These measures were screened113
to identify
those that should be retained for further analysis. The screening process resulted in a list of 22
measures retained for the impact assessment (see Table 6). Each measure is mainly relevant for
a single problem area/objective. Measures which are of a legislative nature bear a “*”.
108
Proposal for a Regulation on general product safety, COM(2021) 346 final.
109
Proposal for a Regulation on a Single Market for Digital Services, COM(2020) 825 final.
110
Regulation 2019/1020, OJ L 169, p. 1.
111
Directive 2011/83/EU, OJ L 304, p. 64.
112
https://echa.europa.eu/about-us/who-we-are/enforcement-forum
113
Screening (see Annex 7) was developed in accordance with Tool #17 of the Better Regulation Toolbox. The longlist
of measures were assessed against eight criteria provided there.
28
Table 6: Retained policy measures (brought forward for the impact assessment)
Measures Description Addressees
Classification of chemical hazards (Policy Option 1)
#1 New hazard classes* Add new hazard classes in CLP for the most critical hazard
properties: ED, PBT, vPvB, PMT, vPvM.
Companies to identify, classify and label their ED, PBT, vPvB, PMT, vPvM
substances. Companies to update their notification if their substance is identified
as ED, PBT, vPvB, PMT, vPvM. Member States or companies to submit
harmonised classification and labelling dossiers for the new hazard classes if they
justify that there is an interest for the EU.
#2 Prioritise new hazard
classes*
Prioritise the new hazard classes (ED, PBT, vPvB, PMT, vPvM)
for harmonised classification, considering the new hazard
classes are of highest concern (same concern as for substances
that are carcinogenic, mutagenic or toxic to reproduction).
Member States competent authorities and/or companies to submit harmonised
classification and labelling dossiers for the new hazard classes. ECHA’s Risk
Assessment Committee to assess the dossier and adopt an opinion to be forwarded
to the Commission. Commission to decide after consultation of expert group.
#3 Justified divergences* Request and make available in ECHA’s classification inventory
the reasons for diverging notified self-classifications.
Companies to update their notification where necessary. ECHA to modify the
CLP classification and labelling inventory to allow for publication of the
justification for diverging classifications for a substance and for reviewing
notifications.
#4 Transparent notifiers* Request publication of names of legal persons notifying their
self-classifications to ECHA.
ECHA to make notifiers’ names public and review confidentiality requests.
Companies to make confidentiality requests in justified cases
#5 Swift notification
updates*
Require notification of updated self-classifications within a
certain deadline after new pieces of evidence is available.
Companies to monitor the availability of new data, update their classifications and
notify them to ECHA at the latest 6 months after new data inducing the change
become available. Companies re-labelling and modifying safety information
provided to users if needed. ECHA to monitor the level of divergence between
notified self-classifications.
#6 Regular notification
updates *
Require update of all notifications every 2 years. Companies to update their notification systematically every two years and re-
classify/re-label/update their safety information114
provided to users if need be.
ECHA to monitor the level of divergence between notified self-classifications
114
Safety Data Sheet in line with REACH Annex 2.
29
#7 Early prioritisation for
harmonised classification
dossiers
Develop prioritisation criteria115
and submit harmonised
classification and labelling dossiers according to a list drawn
from those criteria.
ECHA to use the new hazard classes as additional criteria when screening
registered substances. Commission, ECHA and Member States to develop
prioritisation criteria (including for new hazard classes) and apply them to
substances identified for harmonised classification. Member States to submit
harmonised classification and labelling dossiers according to the prioritisation list
agreed at the Risk Management and Evaluation platform (RIME+)116
#8 EU agreement on
prioritised harmonised
classification dossiers
Member States to agree on the list of future harmonised
classification and labelling dossiers, according to prioritisation
criteria.
Commission, ECHA and Member States to develop prioritisation criteria
(including for new hazard classes). Member States’ competent authorities to
review intentions of harmonised classification and labelling dossiers and agree on
those meeting the prioritisation criteria.
#9 Commission’s mandate
for harmonised
classification and
labelling*
Allow the Commission to initiate and fund more harmonised
classification and labelling dossiers, including by a mandate to
ECHA.
Commission to identify substances where a harmonised classification and
labelling dossier is outstanding. Commission to fund and mandate ECHA and/or
to contract out to Member States’ agencies and/or consultancies for the
development of a harmonised classification and labelling dossier. Commission to
submit the harmonised classification and labelling dossier to ECHA.
#10 Harmonised reference
values *
CLP to not only provide for hazard identification but also for the
setting of toxicity values.
Member States’ competent authorities to submit dossiers for harmonised toxicity
values. ECHA’s Committee for Risk Assessment to assess the dossiers.
Commission to decide after consultation of the Committee.
Communication of chemical hazards (Policy Option 2)
#11 Guidance on labelling ECHA to update guidance to clarify the applicability of the CLP
Regulation and the corresponding rules for chemicals supplied in
very small packaging (e.g. pens), to consumers in bulk (e.g.
fuels) and via refill of containers (e.g. detergents).
Companies to follow new or revised guidance on labelling.
115
Criteria laid down in CLP Art. 36 of CLP set a first level of prioritisation based on the type of hazards. There is a need for additional criteria as a high number of substances meet
those criteria and a harmonised classification cannot be set for all of them over the considered period.
116
RiME+ is an informal forum where ECHA and competent authorities from Member States (Risk Management and Evaluation) platform - RiME+ (Risk Management and Evaluation)
platform - ECHA (europa.eu)
30
#12 Improving
readability*
The Commission to introduce general provisions for a minimum
font size and other provisions to improve the readability of the
label.
Companies to relabel accordingly, to apply the mandatory font size if that font
size is not yet applied.
#13 Voluntary digital
labelling*
Allow some supplemental information to go digital only where
their physical availability on the label is not instrumental for the
protection of health and the environment. In addition, this
measure would create a framework for further digital labelling of
this information. Yet, information that is obligatory under GHS
would remain on the physical label.
Companies to consider the harmonised requirements in case they wish to
digitalise CLP label (on top or instead of the physical CLP label).
#14 Facilitating refill sales
through proper labelling
and other related
requirements*
Provide legal clarity to retailers on the applicable rules for
labelling of containers of refill chemicals. To avoid an
unacceptable risk for health and the environment (e.g. risks of
serious incident during the refill process or later use at home),
refill practice would also be limited to less harmful chemicals.
Retailers to comply with the labelling and packaging rules when selling refill
products. Refill sales to be limited to less hazardous chemicals.
#15 Facilitating the use of
fold-out labels*
Amend labelling provisions to allow for a broader use of fold-
out labels or tie-on tags to increase the effectiveness of hazard
communication whilst facilitating the free movement of
chemicals in the internal market.
Companies allowed using multilingual fold-out labels in more cases.
#16 Labelling exemptions
for chemicals sold in bulk
to consumers and in very
small packaging*
Amend labelling provisions to include a labelling derogation for
chemicals sold in bulk to consumers at filling station (labelling
on the pump will suffice) and for small packaging (e.g. pens).
Companies to benefit from these exemptions and Member States’ competent
authorities to take into account the conditions for the application of derogations.
Closing legal gaps and ambiguities (Option 3)
#17 Rules for online
offerings and
advertisings*
Amend CLP provisions to make them explicitly apply to online
offerings and online advertising and to clarify that labels need to
be provided also for online sales.
Online platforms and online traders to comply with online offering and
advertising rules in CLP and in line with horizontal EU legislation, which is in
place already or currently at draft stage.
#18 Responsible economic Introduce a responsible economic actor by default for imports of Non-EU based actors will be able to place chemicals on the market only when a
31
actor * non-EU goods. responsible economic actor in the EU has ensured that these chemicals meet the
requirements of CLP. The responsible economic actor would be a supplier, acting
in course of a commercial activity (therefore, excluding consumers).
#19 Full notifications to
poison centres*
Request suppliers of chemicals to always notify their mixtures to
poison centres.
All distributors to notify to poison centres.
#20 Notifications to
poison centres by re-
branders and re-labellers*
Define the role of re-branders and re-labellers under CLP and
oblige them to notify to poison centres.
Re-branders/re-labellers would have to notify to poison centres (whilst cross-
border distributors would not have to notify).
#21 Targeted notifications
to poison centres*
Suppliers notify their mixtures to poison centres in case of
information loss, i.e. cross-border distribution or re-branding/re-
labelling.
Distributors (including re-branders/re-labellers) to notify under certain
circumstances.
#22 Awareness campaigns
on online sales
Periodically run awareness campaigns on the display of labelling
elements online.
ECHA or other entities to run such campaigns.
32
The above individual policy measures retained have been packaged into 3 policy options and
(alternative) sub-options which address the three problems and related drivers.
Policy option 1 - Classification of chemical hazards
Policy option 1 (PO1) includes 10 measures, grouped into 4 sub-options, aimed at ensuring
comprehensive identification and classification of chemical hazards (see Table 7).
Table 7: PO1 Classification for chemical hazards
Policy options Drivers addressed by the options
PO1a: New hazard classes (measure #1 New hazard classes)
PO1a would introduce new hazard classes in CLP for substances
with the most critical hazards: EDs, PBT/vPvBs, PMT/vPvMs.
D1. Missing provisions for identification
of critical hazards
PO1a would allow for a systematic
identification of the most critical hazards
(across legislation).
PO1b: Consistent self-classification and improving
transparency (measures #3 Justified divergences, #4 Transparent
notifiers, and #5 Swift notification updates or #6 Automatic
updates)
PO1b aims at improving companies’ self-classification of
substances and at introducing stronger incentives and provisions for
companies to appropriately classify. Measures #5 and #6 are two
different alternatives to ensure timely updates of notifications.
D2. Inefficient procedures for hazard
classification and characterisation
PO1b would improve self-classification
processes, focusing on transparency and
convergence of self-classifications.
PO1c: More and prioritised harmonised classifications
(measures #2 Prioritise new hazard classes, #7 Early prioritisation
of harmonised classification or #8 EU agreement on prioritised
harmonised classification, #9 Commission mandate for harmonised
classification)
PO1c aims at boosting the efficiency and effectiveness of
harmonised classification processes, including for the most critical
hazards. Measures #7 and #8 are alternative options to prioritise
future harmonised classifications.
D2. Inefficient procedures for hazard
assessments and classification
PO1c would improve harmonised
classification processes by making them
faster and more targeted to the most
critical hazards.
PO1d: Complementing hazard identification with hazard
characterisation (measure #10 Harmonised reference values)
PO1d could be complementary to PO1a and PO1b. As part of the
vision and process on “One substance, one assessment”, CLP
would allow for the harmonisation of reference values in order to
be able to quantify the toxicity of hazardous substances, to
complement the identification of their hazards.
D2. Inefficient procedures for hazard
assessments and classification
PO1d aims to help ensuring that
methodologies are made more coherent
and to the extent possible, harmonised, in
particular to ensure convergence of hazard
assessments.
33
Policy option 2 - Communication of chemical hazards
Policy option 2 includes 6 measures (#11 to #16), grouped into 3 sub-options, aiming at ensuring
fully functional communication of chemical hazards (see Table 8).
Table 8: PO2 Communication of chemical hazards
Policy measures Drivers
PO2a: Update/prepare guidance (measure #11 Guidance on
labelling)
PO2a would lead to updating and/or developing on refill
chemicals, chemicals sold in bulk to consumers, chemicals in very
small packaging and on digital labelling.
D3: Complexity of some labelling
provisions
PO2 would aim at supporting
companies in addressing the
complexity of labelling provisions
through clarifying guidance.
PO2b: Improving and making more flexible existing labels
(measures #12 Minimum font size Improving readability, #14
Facilitating refill sales through proper labelling and other related
requirements, #15 Facilitating the use of fold-out labels, #16
Labelling exemptions for chemicals sold in bulk to consumers and
in very small packaging)
PO2b aims at simplifying and complementing current labelling
requirements through provisions that would improve readability
of the labels and clarify the scope of the labelling requirements.
D3: Complexity of some labelling
provisions
Similar to PO2a, PO2a aims at
addressing the complexity of the
labelling rule, but by clarifying their
provisions as well as their scope and
facilitating new forms of trade without
lowering the level of safety.
PO2c: Digital labelling (measure #13 Voluntary digital labelling)
Some supplemental information would go digital only where their
physical availability is not instrumental for the protection of
health and the environment. In addition, PO2c would create a
framework for further digital labelling of this information. Yet,
information that is obligatory under GHS would remain on the
physical label.
D5. Current labelling rules do not
sufficiently exploit new digital tools
PO2c aims at exploiting the potential
of digital labelling while remaining
flexible (see discarded measures on
mandatory digital labelling).
Policy option 3 - Closing legal gaps and ambiguities of CLP provisions
Policy option 3 includes 7 measures (#17 to #22), grouped into three sub-options, aimed at
addressing the legal gaps and ambiguities concerning online sales and poison centre notifications,
and therefore improving compliance (see Table 9).
Table 9: PO3 Addressing the main legal gaps and ambiguities
PO3a: Awareness campaigns (#22 Awareness
campaigns)
PO3a aims at raising consumer awareness on the
chemical risks of buying online.
D6: Rules are inadequate to keep pace with new
means of sale
PO3a aims at increasing the awareness of consumers
on the risks of buying online sale chemicals which
lack hazard information.
PO3b: Provisions and clear responsibilities for
online sales and imports (measures #17 Rules for
online offerings and advertisings, #18 Responsible
economic actor )
D6: Rules are inadequate to keep pace with new
means of sale
PO3b would ensure that CLP rules clearly apply to
online sales and imports of chemicals.
34
PO3b would ensure legal clarity by addressing
shortcomings in CLP provisions on online sales.
PO3c: Clarifying provisions for notifications to
poison centres (measures #19 Full notifications to
poison centres or #20 Notifications to poison centres
by re-branders and re-labellers or #21 Targeted
notifications to poison centres)
PO3c would ensure legal clarity by addressing
shortcomings in CLP provisions on notifications to
poison centres. The three measures are alternative
ways to provide legal clarity.
D7. Unclear provisions on notifications to poison
centres
PO3c would ensure that poison centres receive
updated information also in case of intra-EU
distribution and re-branding/re-labelling, so that
appropriate health response can be taken for people
exposed to hazardous chemicals.
5.3 Options discarded at an early stage
Annex 7 provides the full list of measures that have been considered but discarded and the rationale
behind their screening out from further assessment. The justification for the most relevant discarded
measures is summarised below:
Await new hazard classes at the international level (UN GHS): several industrial stakeholders
were of the view that new hazard classes should be first introduced in GHS, and only after in CLP,
in order to ensure a level playing field and global harmonisation of rules. However, the lack of new
hazard classes was long identified by scientists and stakeholders as an area where urgent action is
needed, and it is one of the high priorities identified in the Chemicals Strategy for Sustainability.
The option was discarded on three main grounds: i) GHS is based on a ‘building block’ system,
leaving margins of flexibility to what their parties can require internally; ii) discussions and
agreements at UN level are very lengthy processes, and former Commission’s and/or EU Member
States’ suggestions of new hazard classes were not successful. EU legislation and standards on
chemicals have traditionally been the driver for higher international standards, including for GHS
and the EU criteria for the new hazard classes would be again the starting basis for a global
discussion; iii) introducing new classes in CLP before GHS could lead to non-tariff barriers to
trade, but, on the basis of modelling from past studies, the impact on international trade was
estimated not be significant and that other variables – such as energy prices – are much more
relevant. Moreover, from a competitiveness angle, acting at EU level first will strengthen the EU’s
role as a global front-runner in health and environmental standards, driving the EU industry’s
leadership in producing and using sustainable chemicals, levelling the playing field, and thereby
giving the EU industry a competitive advantage allowing it to increase its global market share for
chemicals and safer alternatives.
Digital labelling as full alternative to physical label/mandatory digital labelling: these options
were dismissed because of the expected significant costs that they would entail for businesses –
SMEs in particular – and for the difficulties of access for groups of EU citizens due to lack of
access to digital tools, lack of digital skills and/or lack of internet connection. Those options were
also not widely supported by stakeholders, particularly national authorities, as they would deviate
from commitments of the EU under GHS.
35
6 WHAT ARE THE IMPACTS OF THE POLICY OPTIONS?
The impacts were assessed for each policy option proposed, and detailed explanation, including on
the methodology, is provided in Annexes 8 to 16. In chapters 6 and 7 below and in Annex 3, the
impacts have been combined by policy option.
All of the below cost calculations are annual or annualised estimates for a 20-year period, starting
in 2023 and taking into account where necessary a discount rate of 3%, unless stated otherwise.
When possible, lower-bound and upper-bound costs are provided to picture the uncertainties
associated with the estimates provided. Amongst measures under PO1, most of the impacts will
trigger costs for SMEs which are expected to be proportionally higher than those of large
companies. However, for Classification and Labelling Inventory related measures, SMEs are
expected to grasp the benefits of the measure to a greater extent than the large companies.
6.1 Classification of chemical hazards (Policy Option 1)
6.1.1 Economic impacts
6.1.1.1 Administrative costs on businesses and conduct of business and possible benefits on
society
Table 10: Summary of cost and benefits of policy option 1a
Costs - businesses
Total one-off costs over a 20-year period x11 (9%-25%)117
: €587M - €1,253M
PV of one-off costs (20 years; 3%)
of which:
x11 (9%-25%): €39M - €84M
- Direct adjustment costs x11 (9%-25%): €26M - €73M
- Direct administrative costs x11 (9%-25%): €13M - €11M
- Direct regulatory fees and charges -
- Indirect costs x11 (9%-25%): €0.3M - €0.2M
Average cost (PV: 20y; 3%) per person
employed (SMEs)
x11 (9%-25%): €4-€9
Average cost (PV: 20y; 3%) per person
employed (large enterprises)
x11 (9%-25%): €20-€43
Benefits - Society
Number of statistical cases to be avoided per
substance
x11 (9%-25%): 0.62 – 4.97
Benefits per kg PBT/vPvB or PMT/vPvM to
offset PO1 costs
Minimum €0.2 – 0.7
PO1a (New hazard classes) may allow the identification of around 2,320 substances and around
25,520 chemical products containing those substances which would need to be relabelled and/or
voluntarily reformulated (see Annex 8). The annual costs for industry would be €39.4 million -
€84.2 million118
over a 20y period. The average administrative burden per person employed per
year for a large enterprise is €20.1 while for SMEs is €4 (see Annex 8, especially Table 60 page
172).
117
11 mixtures per substance, 9%-25% of substances substituted and 9%-25% of mixtures reformulated.
118
Based on 11 mixtures per substance and a reformulation rate of, respectively, 9% and 25%.
36
Without the new hazard criteria being prioritised, there is a risk of an uneven level playing field
because of diverging self-classifications amongst manufacturers of the same substances. The
changes may temporarily affect EU exports of chemicals classified according to the new hazard
classes. The discrepancy with other main global players is expected to last some years, for the
development of equivalent UN GHS criteria and their following uptake in the national legislation.
This would lead to non-tariff barriers to trade, but, on the basis of modelling from past studies, the
impact on international trade was estimated to not be significant and that other variables – such as
energy prices – are much more relevant.
The European Chemical Industry Council (Cefic) commissioned a study119
to document the
economic impact of various actions announced in the Chemicals Strategy for Sustainability. The
authors concluded that CLP could be responsible for the reduction of 1% of the total potentially
affected portfolio, equivalent to around €5.8 billion.120
However, this figure should be considered
as an illustration of the size of the sectors involved rather than an indicator of economic losses,121
and it is therefore not comparable with the estimates provided in this impact assessment.
Estimating the magnitude of the benefits of the introduction of new hazard classes in CLP and their
complete monetary valuation is confounded by a number of problems, including the possibility of
estimating the attributable fraction of disease incidence, prevalence and mortality to certain
chemical products. Due to the limitation in the availability of data and the large uncertainties
surrounding the monetary evaluation of the health and environmental benefits of the policy action,
a break-even approach was adopted to weigh up the likely relative advantages and drawbacks: for
illustrative purposes, a ‘statistical health outcome case’ was constructed by aggregating the values
of four possible outcomes of EDs’ exposure. The value of the statistical case was then compared
with the total costs, obtaining the number of statistical cases to be avoided per substance identified.
The same approach was used for obtaining the required level of benefits per kg of PBT/vPvB or
PMT/vPvM substances withdrawn from the market to offset the total costs of the policy action. The
socioeconomic burden associated to EDs’ exposure was estimated by different authors as ranging
between tens to hundreds of billions of euros per year. Estimates carried out in the context of this
study for a subset of four health outcomes — among the over 80 health endpoints which have been
associated in the literature to EDs’ exposure — put the socioeconomic burden in over €300 million
per year. How much of the overall burden can be avoided through the CLP revision is unknown,
but considering that the introduction of identification and classification criteria for the new hazard
classes is a prerequisite for the delivery of benefits — directly and indirectly through other
legislative mechanisms — these estimates suggest that, if all attributable impacts were considered,
the benefits are very likely to exceed significantly the costs of the policy option.
PO1b (Consistent self-classification and improving transparency) covers various measures
aiming at improving the inventory of notified self-classification. The direct costs of those measures
are specific (see Annex 11) but the indirect costs such as relabelling, updating the registry and/or
documentation are considered equivalent to other measures. The additional administrative costs
would equate to between €3.99 million and €10.1 million with measure #6 included, of which,
between €1.50 million and €3.84 million would apply to SMEs. These costs would be reduced to
119
Ricardo (2021) Economic Analysis of the Impacts of the Chemicals Strategy for Sustainability – Phase 1 Report
(ED 14790 – Issue number 1, 18/11/2021)
120
Information provided by Cefic in response to a request by the European Commission.
121
A better measure would be the ‘value added foregone’, since it provides an estimate of the Industry’s profits that
would have been earned during the loss period would there be no intervention. This estimate can be calculated by
subtracting the cost of all inputs except capital and labour from the production value. But even this measure is difficult
to take as a proxy of the costs in a cost-benefit analysis or cost-effectiveness analysis, since it is not comparable to
compliance costs. Whether the ‘value added foregone’ is a cost depends on whether the production factors (capital and
labour) can be productively re-employed or not.
37
between €1.96 million and €8.07 million when considering measure #5 as an alternative to measure
#6. Only €1.99 million of those costs are one-off ones. Savings from a quicker navigation in the
CLP classification and labelling inventory could equate to around €8.7 million (including €2.2
million for SMEs), based on a general improvement. The overall impact of PO1b with measure #5
would be between savings up to €4.97 million and costs of €0.93 million. No quantification of
adjustment costs was possible as granular-enough data were missing.
PO1c (More and prioritised harmonised classification) leads to both administrative and
adjustment costs (but no specific ones). No robust quantification of adjustment and administrative
costs was possible in the absence of sufficiently granular data. These measures may have more
impacts on SMEs in relative terms which benefit less from economies of scale and have less
capacity to absorb costs.
PO1d (Complementing hazard identification with hazard quantification) would bear no direct
administrative costs for industry. However, there may be voluntary updates by REACH registrants,
but those adjustment costs are considered outside the scope of this impact assessment.
Table 11: Summary of the economic costs to European businesses (annualised and annual recurrent costs,
central estimates, € million, period: 20y)
Policy option Administrative costs Adjustment costs
PO1a 13.04 (one-off costs) 26.40 (one-off costs)
PO1b 9.43 (of which, 5.14 are recurrent
costs and 4.29 one-off ones)
Existing but not possible to quantify
PO1c Existing but not possible to quantify Existing but not possible to quantify
PO1d (1.00 for authorities) -
6.1.1.2 Public authorities: Change in costs to the Commission, ECHA and Member States
Competent Authorities
PO1a will not entail significant additional costs for ECHA, Member States Competent Authorities
and the Commission. Tasks like identification of PBT substances would be moved from REACH,
plant protection product and biocide regulations to CLP, mostly leading to reshuffling in
resources122
.
Under PO1b, as explained in the baseline, ECHA is already reshaping the IT system for improving
the CLP classification and labelling inventory, and that could also include an IT screening tool.
Manual follow-ups to the IT screening will be needed but it is understood that such resources could
be found via internal reallocation and no additional staff for this task would be required. Measure
#6 (Regular notification updates) and #3 (Update to justify divergences) would however need
additional resources. Lower additional costs are forecasted for measures #4 (Transparent notifiers)
and none for #5 (Swift notification updates).
When considering an early prioritisation step informally at EU level (#8 EU agreement on
prioritised harmonised classification dossiers), costs of PO1c would range from €0.6 million to
€1.1 million to the EU budget. The difference in costs lies in the organisation required to develop
122
e.g. ECHA’s PBT expert group or resources in the Member States Committee assigned for PBT identification.
38
harmonised classification dossiers. The most expensive option — where ECHA is mandated by the
Commission to develop CLH dossiers — is factored in. But as each dossier is different, the most
cost efficient and qualitative process depends on the substance or group of substances at stake.
When it comes to prioritisation, many Member States authorities voiced concerns about the
effectiveness of a formal EU decision on intentions for new dossiers. Therefore, the additional costs
of this option for competent authorities, ECHA and the Commission are not quantified.
The administrative burden related to PO1d (Harmonised reference values) is estimated for Member
States at €0.6 million. Costs to ECHA amount to €0.6 million.
6.1.2 Impact on the environment and on human health
There is no comprehensive evidence available to quantify the impacts on human health and the
environment of the policy packages of PO1. The benefits of all policy packages can however be
qualified.
PO1a would allow to identify more than twice the number of substances than currently under
REACH or pesticide and biocide regulations. Voluntary substitution of chemicals with the most
critical hazard properties (up to 25% of impacted mixtures) would also significantly reduce the
exposure of consumers, workers and the environment (see Annex 8). The reduction of the exposure
to the self-classified hazardous substances would start earlier, but possibly for a lower number of
chemicals than the ones which would fall under harmonised classification, where all manufacturers
would apply the same classification. The consequent reduction of the costs of exposure to EDs for
the EU public health services cannot be fully monetised. However, proper identification,
classification and labelling of EDs, PBTs, vPvBs, PMTs, vPvMs would alleviate part of the ED-
related costs of €46 billion per year. Avoiding between 853 and 1,919 ED-related human outcomes
between 2023 and 2043 would offset PO1 costs for ED substances. This equates to 0.62 to 4.97
cases/outcomes to be avoided per possible candidate substance (see Annex 8).
A reduction of the emissions of ED, PBT, PMT substances into the environment would decrease
the costs of depolluting urban wastewater from micro-pollutants, which currently equal €1.2 billion
per year. If the benefits of withdrawing PBT/vPvB and PMT/vPvM substances are €0.7 or above,
then PO1a would be justified from an environmental point of view.
PO1b and PO1c would enhance the accuracy of hazard information communicated to consumers,
professional users and industrial workers, which will lead to their increased protection from
hazardous substances and mixtures and ensure they dispose of the chemicals in a safe way. This is
expected to have a positive impact on the appropriateness of risk management and waste disposal
measures in the workplace, thus leading to improved environmental protection. This would be
expected to positively reduce pollution affecting aquatic species, surface and ground water and land
contamination. However, this impact would be milder than the one generated by PO1a.
PO1d is not expected to trigger significant direct benefits, as it would be up to sectorial
downstream legislation to provide for the uptake of harmonised reference values. However, as an
illustrative comparison, the harmonised value for N,N-dimethylformamide solvent determined
under REACH was 60% lower than an existing sectorial value. Implementing this harmonised
value would contribute to lower the exposure of workers to that solvent, which is classified as toxic
to reproduction.
39
6.1.3 Social impact
Under PO1a and PO1c, some substances classified according to the new hazard classes (either
through self- or harmonised classification) may be voluntarily phased-out by industry from some
mixtures, in particular those with consumer uses, and replaced by less hazardous alternatives when
possible. The availability of alternatives varies from substance to substance and there is very high
uncertainty on the substances that may be classified for the new hazard classes. It is therefore not
possible to determine the proportion of substances and mixtures that may be withdrawn from the
market because of a lack of alternatives123
.
For PO1b, companies with very large substance portfolios may have to increase their number of
regulatory staff to accommodate the additional regulatory burden (adjustments to diverging
classifications, updates of incorrect classifications). Whilst the estimated costs may not cause
discontinuation of business, levels of employment may increase and the impact is expected to be
weakly positive. As an example, measure #6 would entail about 20,000 working days over 2023-
2040.
No social impact was identified for PO1d.
6.1.4 Stakeholders view on PO1
The introduction of new hazard classes was not disputed and generally strongly supported, even if
industry clearly indicated their preference to propose them at UN level directly (see discarded
options below). It also addresses strong calls from the co-legislators5,6
. The need to improve self-
classification by improving the CLP inventory was shared by the stakeholders in general, though
there were diverging views regarding the way to realise those improvements. However,
stakeholders rated the measures assessed amongst the most appropriate ones in 2017. Public
authorities were not very supportive of measure #6 Automatic updates, doubting that benefits
would balance the costs of revamping the inventory. There was mixed feedback from industry side.
Measure #3 Justified divergences was agreed on content but views diverged when it comes to its
practical feasibility. Regarding measure #4 Transparent notifiers, there were also split views, with
reservations regarding confidentiality needs, especially for substances used for research.
The majority of stakeholders welcomed the measures proposed to improve the number of
harmonised classification and labelling dossiers (measures #7, #8 and #9). However, all categories
of stakeholders pointed that those measures should not add complexity to an already complex
system, nor restrain the Member States’ right of initiative. Several stakeholders also considered that
more resources, specifically at ECHA’s level, should be tapped into the classification processes. A
minority of stakeholders raised the issue of possible complication when the Commission would
disagree with an opinion diverging from the harmonised classification and labelling dossier they
would have initiated. Most of stakeholders also believed that CLP is not the right tool for the
123
Based on the survey of 100 large chemical manufacturers, Ricardo (2021) estimates that businesses may be able to
substitute and reformulated one third of the portfolio, in terms of turnover, likely affected by the changes to the CLP
Regulation and the extension of the generic approach to risk management. According to Ricardo, for around 10% of the
likely affected portfolio it may be possible to apply and obtain derogations, and for 30% of the portfolio, businesses
would have to face increased regulatory burden. The remaining 40% is the net reduction of the likely affected portfolio
in terms of turnover. Such portfolio reduction may have repercussion in terms of competitiveness and employment
levels. However, it is not possible to attribute how much of the reduction would depend on changes to CLP and how
much to the extension of the GRA. Moreover, Ricardo (2021) considers more hazard classes than those proposed in
PO1a. Finally, it is not possible to triangulate this information. In any case, the figures on ‘affected turnover’ or
‘affected portfolio’ provided in Ricardo (2021) should be considered as illustrations of the size of the sectors involved
rather than indicators of economic losses (see discussion above).
40
harmonisation of human and environmental reference values (measure #10). Stakeholders do see
with favour, however, the creation of a new framework for harmonised human and environmental
reference values.
6.2 Communication of chemical hazards (Policy Option 2)
6.2.1 Economic impact
The business impacts of PO2a (New or revised guidance) – drawing from the experience gathered
through the six updates already done by ECHA on the CLP guidance - would be low, both in terms
of costs as well as expected benefits. In particular, benefits for business are expected to be very
limited where legal provisions are unclear or can be interpreted differently.
PO2b (Improving labelling and packaging and making labelling more flexible) is overall
expected to reinforce label readability, ensure that packaging is appropriate and provide legal
clarity and certainty for economic operators and competent authorities compared to the baseline
under which the high non-compliance rate would stay. It would bring limited additional
administrative costs for businesses, and to a larger extent to those, mostly SMEs, selling refill
chemicals and that are not yet complying with the current rules, for an annualised one-off cost
between €23,320 and €40,670124
. It would also provide recurring savings to industry between €20-
59 million per year, because of increased legal certainty and labelling flexibility which would help
to reduce compliance costs.
Allowing digital labelling through a voluntary scheme, under PO2c, would lead to overall positive
economic impacts, as it would provide a harmonised and predictable framework, and, therefore,
administrative burdens for industry would decrease. Digital labels would also allow business to
target consumer groups better, thus offering business opportunities.
Table 12: Summary of PO2 economic costs to European businesses (one-off annualised and annual recurrent
costs, central estimates € million, period: 20y)
Policy option Administrative costs Adjustment costs
PO2a Existing but not possible to quantify -
PO2b 1.72 (of which 1.66 are recurrent
costs and 0.06 are one-off ones)
-
PO2c - Existing but not possible to quantify
6.2.2 Environment and health impacts
The environmental and health impacts of PO2a – drawing from the experience gathered through
the six updates already done by ECHA on the CLP guidance – are expected to be low.
The impact of the clarification of labelling provisions for refills under PO2b (Improving labelling
and making it more flexible) would be positive on public health effects, as consumers would have
complete information and could take informed choices for their health and the environment. It is
understood that their capacity to understand the labelling of chemicals can only improve with the
124
This does not take into account the cost of improving the readability.
41
changes brought under policy option 2. However data available in the supporting study do not allow
for a more granular qualification, especially regarding a detailed analysis of consumer behaviour.
Refill practices have large environmental benefits for the reuse of packaging and related reduction
of resources needed to produce new packaging as well as the consequent reduction in packaging
waste. Simplifying labelling and making it more flexible is expected to also have a small positive
impact in terms of (reduced) packaging waste. In addition, prohibiting the refill sales of chemicals
displaying hazardous properties (such as corrosivity) will limit exposure of consumers and reduce
the likelihood of damage to the environment. Improved readability criteria are expected to increase
the effectiveness of hazard communication for both human health and environment.
For PO2c, additional digital labelling would lead to positive social impacts in terms of increased
understanding of chemical labels and effectiveness of hazard communication for both human health
and environment. Through more comprehensive communication, it could in particular reduce
adverse effects on consumer health stemming from inadequate use of products. As the physical
label as it is today will remain mandatory to a large extent, there will be no negative impact for
population groups without or with limited access to digital tools or the internet. At the same time,
digital labels could have significant positive impacts for vulnerable groups like those with visual or
other impairments (e.g. through the aid of read-out-loud digital labels). Digital labels would also
allow to integrate additional language versions for those users that are not sufficiently fluent with
the official languages of the Member State where they live. Data available in the supporting study
or other impact assessment on digitalisation125
do not unfortunately allow for a more granular
qualification.
6.2.3 Stakeholders views on PO2
With regard the PO2, respondents to the open public consultation generally welcomed a broader
use of multilingual fold-out labels and introduction of tailored labelling rules where there is
insufficient space on the packaging (such as derogations). Most respondents to the open and
targeted consultations emphasised the importance of proper arrangement of content on labels –
effectively using small packaging space by prioritising visual information, reducing the volume of
information on the label, etc. Furthermore, most emphasised the importance of proper CLP
labelling for refill chemicals, in particular to ensure that customers get all relevant safety
information. Similar concerns were raised in the discussions with the Competent Authorities for
REACH and CLP (CARACAL) expert group.
Most stakeholders highlighted the importance and opportunities of digital labelling as innovative
means for hazard communication. However, some respondents – including competent authorities -
expressed concern on digital labels becoming the only means for hazard communication, as citizens
without access to digital technologies or skills would be put in a disadvantaged position. Allowing
digital labelling of a very specific set of information is an overall preferred measure by
stakeholders, as this would also allow for the necessary simplification, while avoiding digital
divides (see more details in Annex 8).
6.3 Addressing main legal gaps and ambiguities (Policy Option 3)
6.3.1 Economic impacts
The costs of PO3a (awareness campaigns) are associated with the operation of a consumer
awareness campaign on online sales. This could be included within existing campaigns (such as the
European Interactive Digital Advertising Alliance) or could be standalone. As the intended target of
125
42
such a campaign would be online consumers, operation of a digital campaign would be the method
of choice, making it relatively inexpensive to operate. Assuming €150,000 in staff costs (3 full-time
equivalents) and €150,000 for equipment and operational costs would imply costs of around
€300,000 per year to the EU budget.
PO3b (Provisions and clear responsibilities for online sales and imports) would not require a
change to the physical label or the packaging to which it is attached. Information would need to be
included in future online adverts/offerings. The costs of such actions would already be borne by
online traders and platforms in order to comply with the General Product Safety Regulation, once
adopted. Sellers based outside the EU would have to sell via a new or already established EU based
responsible economic actor and are likely to have to pay a commission to that responsible actor.
These same costs (to outside sellers) would bring benefits for the newly established responsible
economic actors in the EU. Based on estimations, approximately 32.4 million products subject to
CLP requirements reach EU consumers from outside the EU (see Annex 15). At a value of €20 for
each product (consistent with the €22 VAT free cut-off that applied until July 2021) and a
commission of 2%, this equates to an EU benefit of around €12.96 million per year for chemicals
subject to CLP. A commission of 5% would equate to benefits to the EU of around €32.4 million
per year. Moreover, sellers from outside the EU would have to bear the compliance cost of adhering
to the CLP rules and this would level the playing field between sellers from in and outside the EU,
with sellers from inside the EU benefitting from the resulting fairness in competition. In particular
SMEs relying on online platforms to trade their products would benefit from this adjustment. It was
impossible to assess quantitatively how much it costs to comply with CLP rules, or how much the
EU-based sellers would gain from enhanced competitiveness. Costs for enforcement authorities
would already be partially alleviated by the draft General Product Safety Regulation even if they
would have to check on the responsible actors.
Also national enforcement authorities would have costs to check if responsible actors are appointed
and goods are indeed sold via the responsible actor. These costs will be much lower if rules for
online offerings and savings include a reference to or information on the responsible actor
(combination of #17 and #18, full PO3b).
PO3c (Clarifying provisions for notifications to poison centres) covers three mutually exclusive
measures that would have moderately to high negative impacts on the administrative burden on
businesses (one-off and annualised costs), and neutral to moderate negative impacts on public
authorities. Under PO3c, all policy measures are likely to have a positive market impact in levelling
the playing field across the EU and in improving human health protection. The kind of impacts are
the same, albeit with different magnitudes. Asking all distributors to notify the classification of
their mixtures to poison centres raises annualised one-off costs between €1.5 million and €11.4
million. This can be reduced to €0.05 million and €0.4 million if notifications are required only in
case of information loss. The last option targeting re-branders and re-labellers would cost between
€0.4 million and €3.5 million. The latter would however make the current system more complex by
setting up new actors or roles. As part of the portfolio is reformulated every year, recurrent costs
would amount to 25% of the one-off costs just described (see also Annex 16). The overall cost can
be expected to be less than that of large enterprises, given that SMEs do not distribute cross-border.
Also, companies do not have to pay submission fees to poison centres except for three Member
States126
.
Costs for enforcement authorities under PO3c will increase in order to carry out compliance checks
with the new provisions. Costs for national authorities would be alleviated by ECHA providing a
126
Belgium, Greece, Italy; ECHA overview table of Annex VIII implementation by Member States.
43
centralised dispatch mechanism and searchable database to which Member States can have access
for free (they would just have to adapt their national IT systems to receive the data). Nevertheless,
national authorities could have an increase in costs for poison centres receiving more data and
running their systems. Such adaptation of national IT systems is proportionate with the number of
notifications.
Table 13: Summary of PO2 economic costs to European businesses (one-off annualised and annual recurrent
costs, central estimates € million, period: 20y)
Policy option Administrative costs Adjustment costs
PO3a - -
PO3b -
Existing savings but not possible to
quantify
PO3c 0.4 (recurring cots) Existing but not possible to quantify
6.3.2 Social and environmental impacts
Social (human health) and environmental impacts of PO3a and PO3b are all positive, although the
magnitude of the positive impact varies. Those benefits are associated with a reduction of non-
compliant products circulating in the EU, either because they were sold intra-EU or imported. The
consequence of more compliant products sold online translates into consumers being better
informed about the products they use and better management of their hazards, ultimately limiting
the risk of accidental exposure of consumers and the environment (less spillage, less emissions, less
pollution, safer disposal) to wrongly classified and labelled chemicals127
. The estimated number of
non-compliant items in the EU would be reduced to between 2.4 million and 4 million products per
year depending on the measures, and even more considering synergies between those measures (see
Annex 15).
Regarding the social impacts of PO3c, savings up to €1.12 million are identified as a reduced
number of consumers would be harmed by non-compliant chemicals (see Annex 16). From a
qualitative point of view, clarifying the scope of obligations under Article 45 of CLP (regarding
notification to poison centres) will lead to better and more timely medical advice being given, thus
reducing the number and severity of cases of ill health, and instances where overtreatment is given.
It has been estimated that on average poison centres receive and treat 600,000 calls per year (almost
1,700 calls per day, mostly related to exposure of children to chemicals) and the number of
fatalities related to chemical exposure in the EU is more than 400 per year128
. No negative or
positive environmental impacts are expected from PO3c since Article 45 does not target
environmental hazards.
6.3.3 Stakeholders view on PO3
All stakeholders – industry (including SMEs), national authorities, NGOs - unanimously agreed
that action is needed to adapt CLP to online sales, to ensure safe purchase and use both for goods
originating from in and outside the EU. They stressed that this would further improve consumer and
127
It was impossible to carry out a quantitative estimation of the benefits of fewer non-compliant chemicals circulating.
128
Study on the harmonisation of the information to be submitted to Poison Centres, according to Article 45 (4) of the
Regulation (EC) No. 1272/2008 (CLP Regulation), DocsRoom - European Commission (europa.eu)
44
environmental safety and ensure competitiveness between online and traditional sales. 93% of all
respondents to the open public consultation shared the need to apply the same rules regardless of
the sales’ channel, 99% of all respondents agreed that the display of the hazard information is
essential when purchasing online and 90% agreed that there is need to have a responsible actor in
the EU for chemicals bought online from outside the EU directly reaching the consumer.
Stakeholders also broadly supported measures to solve issues of non-compliance or legal voids in
order to improve information provision on hazardous mixtures to poison centres. Industrial
stakeholders, whether during the open public consultation or via targeted stakeholders surveys,
raised the issue of diverging interpretations by various duty holders, which cause a non-harmonised
approach and an uneven level playing field. National authorities similarly commented at a
dedicated expert group meeting that the current approach is not uniform.
7 HOW DO THE OPTIONS COMPARE?
7.1 Classification of chemical hazards (Policy Option 1)
The different options are complementary.
PO1a is expected to help achieve a comprehensive identification of hazardous substances, with the
extension of CLP to new hazard classes (see Table 14). This will allow increased harmonisation of
classification of hazardous chemicals and hence contribute to the objective of a fully harmonised
internal market for chemicals. It may temporarily affect EU exports of chemicals as the process to
develop equivalent criteria at the international level (UN GHS) and their following uptake in
national law will take some years. On the other hand, if and when these criteria will be integrated in
the UN GHS, and implemented nationally or regionally, it will allow for a wide harmonisation and
related benefits. PO1b focuses on available and transparent up-to-date notification and information
from notifiers. This would reinforce the level playing field in a dynamic way. Companies such as
downstream users often rely on information provided in the CLP classification and labelling
inventory on the substances they use to produce their mixture, in order to classify their mixture.
PO1c completes PO1b by fostering and extending the scope of harmonised classification. It brings
additional costs, counterbalanced by additional added values (e.g., more harmonised classification).
PO1d extends the scope of CLP to hazard assessment. While harmonised human and
environmental reference values are useful, CLP cannot provide for their use in other chemical
legislation, bringing additional costs and little added value.
The best set of measures comes for the combination of PO1a, PO1b and PO1c. There is no
significant added value and almost no support for option PO1d.
7.2 Communication of chemical hazards (Policy Option 2)
The different options are complementary.
PO2a is expected to deliver some benefits in terms of clarifications, especially for topics lacking
specific guidance. Guidance is assessed as ineffective in case the legal text lacks clarity (such as on
the labelling of online offers or on broader use of fold-out labels). Although ECHA guidance on
CLP has been updated several times, some issues are still creating difficulties in terms of
implementation and enforcement. Guidance in itself will, therefore, not suffice to address the
problem. PO2b proposes to strengthen the minimum requirements for hazard communication
introducing obligatory formatting rules such as minimum font size or establishing labelling
obligations. Those requirements partially would result in increased costs for economic operators
and in increased benefits for human health and the environment. Overall, this option results in
45
positive benefits with medium efficiency. PO2c considers measures to simplify the burden of
economic operators in terms of hazard communication without compromising current levels of
safety. Most of the economic benefits are related to a broader use of multilingual fold-out labels.
Overall, this option has a highly positive costs and benefits ratio with a high efficiency. From the
comparison of the options, PO2c displays an effective economic, social and environmental impacts
and benefit/cost ratio.
7.3 Addressing main legal gaps and ambiguities (Policy Option 3)
Amongst PO3c including the mutually exclusive measures #19 (Full notifications to poison
centres), #20 (Notifications to poison centres by re-branders and re-labellers) and #21 (Targeted
notifications to poison centres), #21 would cater for preventing both cases of information loss
without obliging each distributor to notify by default. First the distributor would have to check if a
notification is required and only then it would have to notify. To carry out such checks, a good
supply chain communication with the upstream supplier(s) is paramount for both (i) alleviating the
downstream supplier’s burden of notification and (ii) providing poison centres the utmost detailed
information (as a last resort, they may end-up with a minimal information set). #19 has more
economic impacts on business and administration than #21 and results in the same strongly positive
social impact. #20 would have a weakly negative impact on businesses and administration and be
better than #21 from an economic impact point of view, but worse from a social impact perspective
since it does not cater a solution for cross-border distribution. More, #20 would bring incoherence
to the CLP/REACH framework, since it would result in having a definition of re-branders/re-
labellers in CLP which is not provided for in REACH, leading to inconsistencies between the two
frameworks that should be avoided129
.
Between the alternative options PO3b and PO3a, PO3b is more effective and holistic to address
problems related to online sales. Clarifying the rules for online offerings and advertisings is more
effective than awareness campaigns to make consumers aware about chemical hazards when buying
online since it will help ensuring that online traders and platforms abide by their obligations of
providing chemical safety information when offering or advertising. Consumers might not
remember the content of the awareness campaigns when buying online. Ensuring that there is a
responsible economic operator is the only viable measure for ensuring the compliance of chemicals
sold from outside EU via online sales with CLP requirements and making that economic actor
liable in the EU in cases where imported products directly reach the consumer.
In addressing legal gaps and ambiguities on online sales related matters, PO3b including measures
#17 and #18 is the strongest option given that they are more effective and efficient than PO3a.
In addressing legal ambiguities for poison centres, PO3c and measure #21 is the best option.
129
See recital 12 of CLP advocating for a consistent use of the terms and definitions under REACH and CLP. Based on
REACH Guidance for downstream users, re-branders, which are actors who affix their own brand to a product that
somebody else has manufacturer, are distributors.
46
Table 14: Comparison of measures to improve the hazard classification of chemicals (annualised one-costs and annual recurrent ones, € million)
Options Effectiveness
Key impacts Benefit/cost
ratio
Efficiency Coherence
Consistency with climate
objectives
Economic Social Environmental
PO1a New hazard
classes
High, more than
twice more
substances
identified
compared to the
current
situation.
Negative: costs for industry
between €39.4 and €84.2 million.
Possible temporary impact on
chemical trade
Positive: EU chemical industry at
the global forefront for
sustainable chemistry
Highly positive,
considering the
number of identified
substances and
voluntary substituted
mixtures
Highly positive,
considering the
number of identified
substances and
voluntary
substituted mixtures
High Medium
(without
prioritisation
of the new
hazard
classes, see
PO1c)
Strong (high
level of
protection of
human health
and of the
environment)
No inconsistencies.
Relabelling (recalling
chemicals in the supply chain
to label them and shipping
them again) may generate
some CO2 emissions.
Chemicals which are
voluntarily substituted may
be destroyed, generating
some CO2 emissions.
A mandatory biennial update
may generate some CO2
emissions without added
value (see effectiveness)
Identification of hazardous
substances may slightly
contribute to an environment
more resilient to climate
changes
PO1b Consistent
self-classification
and improving
transparency
Medium (large
companies) to
very high
(SMEs)
Slightly negative to positive:
Between a cost €0.93 million and
savings up to €4.97 million,
mainly for SMEs
Improve the level playing field in
the internal market for chemicals.
SMEs will benefit from this more
than larger companies
Slightly positive (as
the number of agreed
and possibly more
accurate self-
classifications will
increase)
Slightly positive (as
the number of
agreed and possibly
more accurate self-
classifications will
increase)
High Medium Strong
(improved
internal market),
PO1c More and
prioritised
harmonised
classification
Low (in case of
late
prioritisation) to
high (in case of
early
prioritisation)
Negative: costs between €0.75
and 4.71 million euros
Fostering the level playing field
as harmonised classification
applies to all companies of the
same substance, whether SMEs or
larger companies
Slightly positive to
very positive
depending on the
number of substances
with accurate
harmonised
classification
Slightly positive to
very positive
depending on the
number of
substances with
accurate harmonised
classification
High High (as
building up on
increased
benefits from
self-
classification
and the new
hazard
classes)
Strong
(harmonisation
at EU level)
PO1d
Complementing
hazard identification
with hazard
quantification
Medium Neutral, up to slightly positive if
industry uses the harmonised
reference values
Slightly positive Slightly positive Weakly
positive
Weak Weak
47
Table 15: Comparison of policy options for hazard communication.
Options Effectiveness
Key impacts
Benefit/cost
ratio
Efficiency Coherence
Consistency with climate
objectives
Economic Social Environmental
PO2a
Update/prepare
guidance
Limited
extension of
clarifications
Neutral to weakly
positive as (existing)
guidance is not always
implemented
Minimal positive Minimal positive Very limited
benefits with
very limited
costs
Low Neutral Neutral as minimal changes
are foreseen
PO2b Improving
and making
more flexible
existing rules
High – in
tackling
absence of
labels and
increased
readability and
burden
reduction and
cost savings
Highly positive: the
limited negative impacts
are offset by savings (up
to €59 million) from
labelling simplification.
The savings may be
higher for larger
companies than SMEs.
Highly positive (increased
safety information
available to users and
simplification provided
without significantly
lowering safety)
Slightly positive (e.g.
through increased
awareness of impacts of
dispersion of harmful
substances in the natural
environment)
Highly positive High Highly
positive
In the long term, it would
reduce CO2 emissions thanks
to legislative streamlining.
Refilling would bring benefits
in terms of packaging waste
reduction, hence energy saved.
PO2c Digital
labelling
Weakly
positive
Weakly positive, as the
application would be
voluntary (application
where companies’
benefits outweigh their
costs). The volunteer
companies would be
digital/future proofed
front-runners
Highly positive (digital
information complements
the information on labels)
Weakly positive Highly positive
(companies
would
implement this
on a voluntary
basis, meaning
in cases where
their benefits
outweigh their
costs)
Neutral Highly
positive
Neutral
48
Table 16: Comparison of policy options to address the non-compliance of online sales of chemicals and insufficient information to poison centres
Options
Effectivenes
s
Key impacts
Benefit/cost
ratio
Efficiency Coherence
Consistency with climate
objectives
Economic Social Environmental
PO3a
Awareness
campaigns
Very low Very small to moderately
negative
Weakly positive. Weakly positive Limited
benefits/small
costs
Rather low Coherent with
Digital Agenda
Neutral
PO3b
Provisions and
clear
responsibilities
for online sales
and imports
High for
PO3b.
Positive – limited costs for
EU industry and online actors
while providing a level
playing field between EU and
3rd
country actors.
Positive – increased
level of information
and enforceability,
reinforcing the
protection of citizens
Positive – increased level
of information and
enforceability, reinforcing
the protection of the
enviroment
High as there
are no costs but
some benefits
high Coherent with
Digital Agenda
and with the
competitiveness
of EU online
and brick and
mortar actors.
Neutral
PO3c Clarifying
provisions for
notifications to
poison centres
Highly
effective but
very
burdensome
Very negative for industry,
negative for national
authorities;
Positive N/A High costs/high
benefits
Moderate N/A Neutral
Solves only
part of the
problem
Moderately negative for
industry and authorities
Positive Moderate
costs/moderate
benefits
Moderate
High Negative for industry, neutral
to moderately negative for
authorities
Moderately positive Moderate
costs/high
benefits
High
49
8 PREFERRED OPTION
8.1 Description of combined preferred option
Table 17 below lists the options and list of measures retained in the preferred policy
package.
Table 17: Preferred policy options and related measures
Classification of chemical hazards
PO1a,
PO1b and PO1c
 Add new hazard classes in CLP for substances with ED, PBT, vPvB, PMT,
vPvM properties and prioritise them for harmonised classification
 Request and make available in ECHA’s classification and labelling inventory
the reasons for diverging notified self-classifications and make the names of
notifiers public
 Require updates of notifications of self-classifications within a certain deadline
 Reinforce prioritisation for harmonise classification at an early stage
 Allow the Commission to initiate and fund more harmonised classification and
labelling dossiers, including by mandate to ECHA
Communication of chemical hazards
PO2b and
PO2c
 Explicitly address the concept of refill and labelling obligation of chemicals in
the CLP and limit this practice to mild hazards only
 Increase readability of CLP labels for chemicals introducing specific
formatting requirements for CLP labels as currently already outlined in
guidance
 Allow some supplemental information to go digital only where their physical
availability on the label is not instrumental for the protection of health and the
environment. In addition, this measure would create a framework for further
digital labelling of this information. Yet, information that is obligatory under
GHS would remain on the physical label.
 Allow broader use of fold-out labels for chemicals traded in several EU
countries
 Provide derogation from labelling requirements for chemicals sold to
consumers in bulk (e.g. fuel) and in very small packaging (e.g. writing
instruments)
Addressing main legal gaps and ambiguities
PO3b and
PO3c
 Clarify rules for online offerings and advertisings
 Introduce a responsible economic actor by default
 Targeted notifications to poison centres
50
The preferred policy package will generate significant and positive health and
environmental impacts (especially from PO1a and PO2b) and incur limited negative
economic impacts (considering all retained policy options). Overall costs will be largely
outweighed by the benefits, whilst the problems identified by the previous policy
evaluations would be comprehensively addressed. The package would strongly
contribute to achieving the EU’s ambition embedded in the European Green Deal and the
Chemicals Strategy for Sustainability in terms of moving toward a toxic free-
environment, as well as to supporting the green and digital transition of industry, as
defined in the Industrial Strategy. Also, an overall improvement of certain legal
provisions and the closure of identified legal gaps would lead to better implementation,
simplification and compliance (expected through PO3b and PO3c but also by
simplification/clarification of labelling provisions under PO2b and c) bringing about
environment/health benefits as well as fostering the level playing field for EU
companies and thereby enhancing competitiveness (including for SMEs). The impact
assessment concludes that policy options 1d, 2a and 3a and some measures within PO3c
(measures #19 and 20) will not materialise in benefits and increased effectiveness. Those
options are dropped, even if they do not contain significant costs.
Health and environmental benefits would stem in particular from ensuring that
adequate provisions exist for identifying and classifying for the most critical hazards, so
that other actors can take adequate risk management measures, and so that processes can
deliver outcomes faster (e.g. through the mandate to the Commission to initiate
harmonised classifications dossiers). Other relevant expected benefits for health and the
environment would stem from the expected improvement in the consumers’
understanding of the health and environmental hazards of chemicals (and ultimately of
their ability to make informed choices), thanks to improved labelling. This includes a
voluntary and harmonised scheme to facilitate and promote digital labelling - as well as
addressing legal gaps and ambiguities in the CLP rules for online sales and imports.
Further benefits on health would be guaranteed by ensuring that comprehensive
information on chemical hazards effectively reaches poison centres.
Economic impacts are estimated to be significant for industry and authorities, in
particular for PO1. Inevitably, the new hazard classes will come along with additional
costs for the industry compared with status quo (direct costs, which will be borne
progressively as substances to be classified for the new hazard classes are identified,
mainly thanks to REACH, BPR and PPPR, and indirect costs such as voluntary
substitution). The European chemicals industry is ready to bear those costs130
, as long as
the EU policy maker ensures investment predictability on which chemicals will
undergo regulatory measures and when. The identification will be coordinated and
communicated at EU level, in order to provide investment predictability in the single
market. Targeted initiatives by the Commission will ensure such predictability131
.
Concerning costs for authorities, PO1 will imply certain costs which would amount to
between €39.4 and 84.2 million (central estimates) also for them to adapt to changes
involving classification criteria for new hazard classes (minor costs), improvements of
the classification and labelling inventory (moderate costs) and the prioritisation schemes
(moderate costs).
130
CEFIC, Chemicals Strategy for Sustainability - cefic.org.
131
E.g., see the planned transition pathway for chemicals that CEFIC fully supports; CEFIC, Chemicals
Transition Pathway.
51
Efficiency gains – for authorities as well as for companies - would be generated by an
overall improvement of the classification processes, but also by the simplification and
clarification of the labelling requirements. This will warranty a fully harmonised internal
market for chemicals. Labelling requirements will become easier to apply translating into
less compliance costs for industry abiding by the rules as well as into easier
enforceability by authorities of non-compliant competitors. The preferred package under
PO1 would also significantly promote synergies and coherence of EU legislation on
chemicals, in line also with the overall process of ‘One substance, one assessment’
initiated with the Chemicals Strategy for Sustainability across EU legislation and aimed
at harmonising safety assessments on chemicals. In particular, harmonised identification
and classification for the most critical hazards, but also ensuring stronger convergence of
self-classifications by industry as well as greater transparency, are essential to achieve
this goal.
Furthermore, actions on digital labelling under PO2 and online sales under PO3 will
encourage the use of digital tools for improving consumer awareness on chemicals
hazards, while at the same time managing the challenges posed by increased
digitalisation and globalisation and new trends in sales of consumer products.
The overall impact of the preferred option is summarised in Annex 3.
8.2 Potential for burden reduction and simplification
Measures included in PO1b and PO2c, in particular, are expected to bring high benefits
in terms of burden reduction and cost savings for industry, as well as stronger basis
for Member States’ Enforcement Authorities. They are indeed expected to simplify the
burden of economic operators in terms of hazard classification (without lowering on
safety), in particular through a simplified and easy to search inventory (savings estimated
slightly less than €9 million). On the side of hazard communication, a broader use of
multilingual fold-out labels (savings estimated to about €48.5 million considering the
detergent industry only) and introducing exemptions to labelling requirements for some
chemicals (savings amounting to more than €10 million) will also add up. This preferred
option will therefore also contribute to the ‘one in, one out’ commitment of the European
Commission. As experience and confidence is gained, increasing the amount of
information available digitally may further increase the simplification potential for
industry, provided that this possibility exists without violating EU commitments under
GHS.
Measures related to self-classification under PO1b, i.e. to improve the Classification and
Labelling Inventory will bring about simplification. Strengthened rules to come to an
agreed entry will level the playing field also for the vast majority of substances that do
not have a harmonised classification. This is particularly important for SMEs who notify
substances that are not subject to REACH registrations because they are manufacturing
or importing them below one ton. Hence, the data provided in the inventory regarding
those notifications is the only benchmark for SMEs dealing with the same substance.
Indeed, if notifiers know each other’s name, they will spend less time navigating the
inventory. Also, providing a maximum of 6 months to update a notification after a change
of classification has been decided, will trigger a burden reduction and simplification as
companies are given more time to re-notify. Measures under PO1a do not directly imply
a burden reduction for companies, but they might if one would take into account the costs
of non-Europe. A coherent, EU-wide framework will prevent national initiatives putting
at risk the internal market for chemicals, which we have already seen from some Member
52
States, and which would no doubt proliferate if the Commission would remain inert132
.
Also, pushing the EU model on new hazard classes forward at GHS will translate into the
EU industry being the global front-runner in health and environmental standards, driving
the EU industry’s leadership in producing and using sustainable chemicals, and thereby
giving it a competitive advantage allowing it to increase its global market share for
chemicals. In the long run, this should be a burden reduction.
Measures under PO3b on online sales will not directly reduce the burden for EU industry,
but they will protect it from non-EU free-riders undermining competitiveness. Whilst EU
industry will not have any additional burden, non-EU actors will have to appoint a
responsible economic actor in the EU if they want to continue placing their chemicals on
the market. In other words, the burden will be levelled.
8.3 Application of the ‘one in, one out’ (OIOO) approach
The recurrent and one-off costs and savings for businesses, citizens and public authorities
are presented below:
Table 18: Administrative costs for businesses, citizens, and public authorities for the preferred policy
option
New Recurrent
costs (m€)
Savings in
recurrent costs
(m€)
New-one off
costs (Total in
m€)
One-off savings
(Total in m€)
Within the scope of ‘one-in-one-out’
Business 23.2 57.4 258.7 13.5
Citizens 8.6 0.0 0.0 0.0
Total 31.8 57.4 258.7 13.5
Outside of the scope of ‘one-in-one-out’
Public
authorities
1.0 0.3 13.5 0.00
The preferred option would create net savings in recurrent administrative costs on
businesses and citizens of 25.6 million EURO per annum. The preferred option would
however impose net (total) one-off administrative costs on businesses and citizens of
245.2 million EURO. Public authorities will be expected to have slightly increased
recurrent administrative costs of 0.7 million EURO and additional one-off administrative
costs of 13.5 million EURO.
9 HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED?
The Chemicals Strategy for Sustainability recognises the need to improve knowledge on
chemicals and commits to develop by 2024 a ‘framework of indicators to monitor the
drivers and impacts of chemical pollution and to measure the effectiveness of chemicals
132
Five Member States (Belgium, Denmark, France, The Netherlands and Sweden) launched a website in
June 2020 having the aim of informing stakeholders about the current status of substances identified as
EDs to increase the knowledge base on them (https://edlists.org/about-this-site). Those Member States call
for action at EU level (https://www.wemos.nl/wp-
content/uploads/2016/06/Measures_against_endocrine_disrupting_chemicals_June2016.pdf). France
already adopted a decree on ED identification (Article L541-9-1 of the French Public Health Code).
53
legislation’. The development of this framework is currently ongoing, with the close
involvement of the expertise of all relevant services, in particular the European
Environment Agency (EEA) and ECHA. This framework of indicators under
development is flexible in the medium to long term and will be able to align with
ongoing revisions of the chemicals legislation, in order to ensure that specific objectives
of those can be duly monitored. A number of areas and potential indicators have been
identified for further technical work amongst which the following are relevant for the
CLP revision, in addition to the existing ones on consumption and production of
hazardous chemicals:
 Production and consumption of chemicals, including in terms of turnover,
consumer expenditure etc., with a focus on SMEs, online sales, and non-EU sales;
 Safe and sustainable by design chemicals including key performance indicators
on the industrial transition to safe and sustainable chemicals;
 Consumption footprint, chemicals in products and in the Circular Economy;
 Environmental and human (bio)monitoring;
 Enforcement of REACH and CLP.133
This framework will be fully aligned – as well as complementing - the Monitoring and
Outlook Framework for the EU Zero Pollution Action Plan and the monitoring
framework of the Environmental Action Programme to 2030 (8th
EAP).
In terms of some specific objectives of the CLP revision, a number of additional streams
will also be extremely relevant and would feed into a future evaluation of the revised
CLP:
 Identification and classification of hazards: It is foreseen to periodically (once
a year) assess via the Integrated Regulatory Strategy performed by ECHA the
number of substances for which harmonised classification is needed for the most
critical hazard classes and take stock of the number of substances for which the
classification was harmonised. The Classification and Labelling Inventory will be
analysed periodically to identify the level of harmonisation of self-classification,
the number of updated notifications as well the number of substances newly
classified for the new hazard classes. Compliance check of registration dossiers
performed under REACH could also be used to assess the adequacy of the
classification of registered substances for the new hazard classes.
 EU barometer surveys: Eurobarometer surveys provide very useful information
on how citizens/consumers feel well informed about the dangers and safety of
chemicals and on their level of understanding of labelling. As the last
Eurobarometer survey found that about 55% of the interviewers felt not well
informed, it is proposed that after 5 years from the entry into force of the new
measures a new survey includes questions to assess progress on the level of
knowledge and understating on the safety of chemicals.
 EU enforcement projects: the level of compliance with CLP rules is regulatory
monitored by ECHA’s Forum for Exchange of Information on Enforcement (the
Forum), a body of the Agency that constitutes a network of authorities
133
Although purely enforcement related matters of CLP will not be dealt with in this impact assessment as
outlined under 5.1.4.
54
responsible for the enforcement of REACH, CLP, the ‘Prior Informed Consent
Regulation’134
, the ‘Persistent Organic Pollutants Regulation’135
and the ‘Biocidal
Product Regulation’. The Forum has been driving in the past years a number of
EU wide enforcement studies (led by ECHA’s secretariat), which have been
instrumental to identify the level of non-compliance of CLP across EU Member
States. Those studies were also widely used for the evidence collected for this
impact assessment, in particular to identify the communication gaps on labelling
and the implementation gaps for online sales and imported articles. As the
Chemicals Strategy for Sustainability also prioritises those areas for further action
by Member States and the Forum, it is proposed to monitor progress on those
through targeted Forum activities. Those data will also feed into the overall
enforcement and compliance indicators as part of the future framework of
indicators on chemicals (currently under development).
134
Regulation (EU) No 649/2012.
135
Regulation (EU) 2019/1021.


EN EN
EUROPEAN
COMMISSION
Brussels, 19.12.2022
SWD(2022) 435 final
PART 5/5
COMMISSION STAFF WORKING DOCUMENT
IMPACT ASSESSMENT REPORT
Accompanying the document
Proposal for a Regulation of the European Parliament and of the Council
amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council
on classification, labelling and packaging of substances and mixtures
{COM(2022) 748 final} - {SEC(2022) 452 final} - {SWD(2022) 434 final} -
{SWD(2022) 436 final}
Offentligt
KOM (2022) 0748 - SWD-dokument
Europaudvalget 2022
466
Q18. To what extent could the information of fertiliser be removed from the on-pack
label and transferred to a digital label?
First of all, the majority of the respondents across all stakeholder groups are of an opinion that
for the production date1
, and the function of the product2
, all information should remain on
the on-pack label.
Then, regarding the possibility to move some information on a digital label, the majority of
the respondents think that the information from the on-pack label should be transferred to a
digital label concerning: coating agents (for coated fertilisers)3
, Low in cadmium statements4
,
Poor in chloride statements5
, and the List of ingredients6
.
In addition, respondents provided that at least basic information could be provided on pack
and more details on a digital label for the following category of information7
: solubility of
phosphorus; reference to inhibitors, chelating and complexing agents; measures to mitigate
risks; product storage instructions; and product use instructions.
In regards to the other parts of the information, the respondents had different views on what
kind of information should remain on the on-pack label, should be kept on the on-pack label
and more details provided via a digital label, or transferred to a digital label completely. The
full overview of the responses to this question is provided in the table below.
1
55 out of 100 total responses.
2
58 out of 103 total responses.
3
50 out of 92 total responses.
4
58 out of 95 total responses.
5
51 out of 95 total responses.
6
56 out of 103 total responses.
7
Based on the combined answers given for “basic information should be kept on pack and more details provided
via a digital label” and “information should move to a digital label”.
467
However, regarding the answers given specifically by stakeholders representing consumers,
the answers are more divided and no consensus can be found regarding a category of
information that should move completely to a digital label. According to the answers given by
this stakeholder group, information could be moved online if basic information are kept on
pack and only more information are provided on a digital label, for the following categories of
information8
: product use instructions; product storage instructions; nutrients content, organic
carbon / dry matter content; poor in chloride; low in cadmium; references to inhibitors,
chelating and complexing agents; solubility of phosphorus; and coating agents.
Q18a-e. To what extent could the information of a fertilising product mentioned below
be removed from the on-pack label and transferred to a digital label?
Overall, the analysis did find substantial differences, and answers were consistent among the
different fertilising products.- Respondents agreed that the following information needed to
stay on pack for all products: quantity (and granulometry/volume where relevant) and the
function of the product. In addition, other categories of information relevant for:
1 liming material: the calcium oxide and magnesium oxide, as well as reactivity of the
product;
2 soil improver: dry matter content, pH value, nutrients content and organic Carbon
(Corg) content;
3 growing medium: the production date;
8
Based on the combined answers given for “basic information should be kept on pack and more details provided
via a digital label” and “information should move to a digital label”.
42%
56%
46%
41%
31%
28%
25%
22%
22%
20%
55%
22%
29%
14%
46%
35%
42%
21%
40%
48%
47%
23%
24%
19%
30%
36%
25%
32%
12%
9%
12%
39%
29%
25%
27%
54%
54%
61%
15%
42%
46%
54%
0% 25% 50% 75% 100%
Quantity, form of the physical unit, granulometry
Function of the product
Nutrients content
Organic carbon / dry matter content
Product use instructions (including application rates, timing…
Product storage instructions
Measures to mitigate risks, including environmental…
List of ingredients
Poor in chloride
Low in cadmium
Production date
References to inhibitors, chelating and complexing agents…
Solubility of phosphorus (where relevant)
Coating agents (for coated fertilisers)
All information should remain on the on-pack label
Basic information should be kept on the on-pack label and more details provided via a digital label
Information should move to a digital label
468
4 biostimulant: the physical form, production date and expiry date.
Were indicated to be kept on-pack.
Regarding information that could be moved to a digital label, respondents indicated for all
types of fertilising products that the list of ingredients and poor in chloride could be moved
digitally. In addition, for liming material, respondents indicated the information on
neutralising value cold be moved online.
Finally, respondents also indicated a consensus for all products categories to keep some basic
information on pack, and provide more details via a digital label for the following categories
of information: the product use instructions, the products storage instructions, and the
measure to mitigate risks, including environmental statements.
Compared to the stakeholders from the industry, consumer representatives were, in general,
less keen to transfer from the on-pack label and to digital label. These stakeholders supported
keeping the information on pack, especially for the inhibitors, soil improvers and, generally,
the information regarding the quantity and the function of the products, and keeping basic
information on the on-pack label and having more details provided via a digital label,
particularly for bio stimulants and, generally, product storage instructions of fertilising
products.
Q19. To what extent do you think that the following pieces of information could be
removed from the on-pack label of a detergent and transferred to a digital label?
The majority of the respondents believe that the name of the product should remain on the
on-pack label9
, while for use instructions the majority of the respondent indicated that basic
information should be kept on the on-pack label and more details could be provided via a
digital label10
. Similarly, the majority of the respondents stated that basic information on
special precautions, where required, should be kept on pack while the details should be moved
to a digital label.
In regards to the other parts of the information, the respondents had different views on what
kind of information should remain on the on-pack label, should be kept on the on-pack label
and more details provided via a digital label, or transferred to a digital label completely. For
none of the items there was a majority to move all information to a digital label though for the
list of ingredients this group was particular large. The full overview of the responses to this
question is provided in the table below.
9
102 out of 151 total responses.
10
79 out of 150 total responses.
469
This finding needs to be mitigated by the aswers given specifically by consumer
representatives, who were in general less inclined to move information online.Within this
stakeholder group, the majority of respondents indicated that all information should remain on
pack for the following categories of information: name of the product11
, instructions for use12
,
dosage recommendations13
, nominal quantity of mixtures14
, and special precautions15
. Finally,
consumer representatives expressed different/mixed views regarding the following pieces of
information: address and telephone number of the manufacturer16
and list of ingredients17
.
Q19a. For information that you would like to see listed on-pack, please explain why this
is:
There was no clear consensus among the respondents on the key reasons why certain
information should be listed on-pack, however the most popular option between the
respondents was “Because this information allows me to use the product safely”18
.
Among consumer representatives, the most popular option was “because this information
helps me make a purchase decision”19
, followed by “because this information allows me to
use the product safely”20
, and “because I consider some ingredients to be
dangerous/harmful”21
.
11
33 out of 52 answers within this stakeholder group.
12
29 out of 52 answers within this stakeholder group.
13
30 out of 52 answers within this stakeholder group.
14
27 out of 51 answers within this stakeholder group.
15
27 out of 52 answers within this stakeholder group.
16
N=52, 19 answered that “All information should remain on pack”; 19 answered that “basic information should
remain on pack and more details provided via a digital label”; and 14 answered that “Information should move to
a digital label”.
17
N=51, 21 answered that “All information should remain on pack”; 14 answered that “basic information should
remain on pack and more details provided via a digital label”; and 16 answered that “Information should move to
a digital label”.
18
122 out of 413 total choices.
19
41 out of 52 answers.
20
39 out of 52 answers.
21
34 out of 52 answers.
68%
44%
39%
47%
47%
25%
40%
30%
36%
53%
42%
32%
30%
48%
2%
20%
8%
11%
21%
45%
13%
0% 25% 50% 75% 100%
Name of the product
Address and telephone number of the manufacturer
Instructions for use
Dosage recommendations
Nominal quantity of the mixture
List of ingredients
Special precautions, where required
All information should remain on the on-pack label
Basic information should be kept on the on-pack label and more details provided via a digital label
Information should move to a digital label
470
Q20. To what extent could the following ingredients be removed from the on-pack label
of a detergent and transferred to a digital label?
Around half of the stakeholders (mostly industry stakeholders) believe that the information
from the on-pack label of a detergent should be moved to the digital label for the following
ingredients: Enzymes22
; Aliphatic hydrocarbons23
; Polycarboxylates24
; Soap25
; Zeolites26
;
NTA and its salts27
; EDTA and its salts28
.
In regards to the other ingredients, the respondents had different views on what kind of
information should remain on the on-pack label, should be kept on the on-pack label and more
details provided via a digital label, or transferred to a digital label completely. The full
overview of the responses to this question is provided in the table above.
However, the answers given by citizens and consumer organisations indicates less willingness
to move information to a digital label. No categories of information received a majority of
answers to move information online. The only consensus expressed within this stakeholder
category is the need to keep allergenic fragrances on pack.29
Q20a. For information that you would like to see listed on the on-pack label, please
explain why this is:
22
66 out of 125 total responses.
23
61 out of 123 total responses.
24
66 out of 122 total responses.
25
65 out of 126 total responses.
26
67 out of 123 total responses.
27
66 out of 124 total responses.
28
63 out of 124 total responses.
29
29 out of 47 answers.
26%
22%
25%
29%
19%
19%
24%
18%
17%
19%
26%
22%
27%
25%
22%
23%
20%
22%
27%
48%
28%
30%
41%
40%
30%
28%
28%
28%
32%
27%
28%
28%
28%
28%
29%
34%
31%
39%
36%
35%
46%
48%
34%
31%
51%
53%
49%
54%
52%
54%
47%
50%
45%
47%
50%
43%
49%
39%
37%
17%
0% 25% 50% 75% 100%
Phosphates and phosphonates
Surfactants
Oxygen based bleaching agents
Chlorine based bleaching agents
EDTA and its salts
NTA and its salts
Phenols
Zeolites
Soap
Polycarboxylates
Paradichlorobenzene
Aliphatic hydrocarbons
Aromatic hydrocarbons
Halogenated hydrocarbons
Enzymes
Disinfectants
Optical brighteners
Perfumes
Preservatives
Allergenic fragrances
All information should remain on the on-pack label
Basic information should be kept on the on-pack label and more details provided via a digital label
Information should move to a digital label
471
There was no clear consensus among the respondents on the key reasons why certain
ingredients should be listed on-pack, however, the most popular option between the
respondents was “Because this information allows me to use the product safely”30
.
It must be noted that the most popular option among respondents from citizens and consumer
organisations was “because I consider some ingredients to be dangerous/harmful”31
, followed
by “because this information helps me make a purchase decision”32
.
Q21. In what ways do you think that the information on the detergents label could be
simplified: (multiple choice possible)
Likewise, there also was no clear consensus among the respondents on the ways that the
information on detergents label could be simplified. Nevertheless, the most popular option
between the respondents also for respondents from citizens and consumer organisations33
was
“Avoiding that the same ingredient is listed multiple times on the label34
”,
Q22. To what extent could the following ingredients be removed from the on-pack label
of a chemical product (such as a glue, lamp oil, paint, solvent, etc.) and be transferred to
a digital label?
The majority of the respondents, including consumer representatives35
think that all
information should remain on the on-pack label concerning the: identification code for
poison centers36
; hazard statement or signal word37
; and pictogram showing the risk38
.
In regards to the other sources of information, the respondents (including consumer
representatives) had different views on what kind of information should remain on the on-
pack label, should be kept on the on-pack label and more details provided via a digital label,
or transferred to a digital label completely. The full overview of the responses to this question
is provided in the table below.
30
84 out of 304 total choices.
31
38 out of 44 answers.
32
35 out of 44 answers.
33
45 out of 53 answers.
34
113 out of 522 total choices.
35
39 out of 50 answers for “pictogram showing the risk”; 35 out of 49 answers for hazard statement or signal
word”; and 31 out of 50 answers for identification code for poison centers”.
36
106 out of 158 total responses.
37
109 out of 156 total responses.
38
121 out of 157 total responses.
472
SPECIFIC QUESTIONS FOR PROFESSIONALS AND INDUSTRY
In this part of the questionnaire, all industry stakeholders were asked to answer the questions
related to the practicalities of using digital labelling.
Q23. Industry stakeholders were asked to give more information about the type of
organisation they represent, and in which sectors (multiple choice is possible).
Most industry representatives indicated their organisation was active in the sector of ‘other’
chemical products39
(in other words, ‘other to fertilising products or detergents’), followed by
fertilising products40
, while least were active in the detergents41
sector. Please see more details
in the table below on the different types of industry stakeholders:
The following questions were asked to all industry stakeholders responding to the
survey:
39
182 out of 368 total choices (49%) across the 10 terms.
40
154 out of 368 total choices (42%) across the 10 terms.
41
32 out of 368 total choices (9%) across the 10 terms.
77%
70%
36%
30%
34%
67%
22%
26%
48%
37%
33%
19%
1%
4%
16%
33%
34%
14%
0% 25% 50% 75% 100%
Pictogram showing the risk
Hazard statement or signal word
Precautionary statements on how to store, dispose, prevent
accidents, etc.
The name of the chemicals causing the hazard
Additional specific labelling information
Identification code for poison centers
All information should remain on the on-pack label
Basic information should be kept on the on-pack label and more details provided via a digital label
Information should move to a digital label
3%
6%
6%
6%
8%
11%
9%
14%
26%
50%
48%
42%
43%
44%
39%
56%
45%
22%
42%
33%
49%
52%
52%
50%
53%
33%
45%
65%
32%
17%
0% 25% 50% 75% 100%
Manufacture or produce
Blend
Sell
Import/Export
Repackage/Relabel
Representative
Distribute
Use
Other
None of the above/cannot answer
Detergents Fertilising products Other chemical products
473
Q24. Do you currently provide any product information via IT solutions or digital tools?
The majority of the industry stakeholders (74%42
) do provide information about their products
via IT solutions or digital tools. Almost half of the respondents from the industry provide
additional/complimentary information to an on-pack label, while around one-quarter of the
respondents provide the same information online that was presented on the on-pack label.
Q25. What are the main reasons for providing information online? (multiple choice
possible)
There was no clear consensus among the industry stakeholders on the key reasons to provide
information online, however, the most popular option between the respondents was
“Improved customer service”43
.
Q26. Please rate the main benefits of introducing a regulatory framework on digital
labelling of chemicals for your organisation?
The majority of the industry stakeholders have rated all of the listed benefits44
as moderately
beneficial or extremely beneficial with the benefit called “Better management of fast
changing label information” as the most beneficial45
, followed by ”, “Increased ease of
complying with labelling requirements”46
, “Better targeted communication”47
, and “Cost
savings” as the least beneficial” option48
.
Q27. How would you see the following challenges if digital labelling was introduced?
Around half of the industry stakeholders have assessed the challenges associated with the
“Increased costs associated with training”49
and “Increased costs associated with changes to
design /packaging”50
as a little challenging or not challenging at all, while around half of
the respondents have rated the challenge of “Implementing IT solutions”51
as moderately or
extremely challenging. The opinion of the stakeholders on other challenges proved to be
more diverse and marginalised. However, only a minority of respondents considered the
introduction of digital labelling as extremely challenging.
42
123 out of 167 total responses.
43
97 out of 390 total choices.
44
The listed benefits included: “Better management of fast changing label information”, increased ease of
complying with labelling requirements”, better targeted communication” and “cost savings”.
45
111 out of 124 respondents (90%) have selected options “Extremely beneficial” or “Moderately beneficial”.
46
106 out of 125 respondents (85%) have selected options “Extremely beneficial” or “Moderately beneficial”.
47
106 out of 125 respondents (85%) have selected options “Extremely beneficial” or “Moderately beneficial”.
48
65 out of 117 respondents (56%) have selected options “Extremely beneficial” or “Moderately beneficial”.
49
61 out of 122 total responses (50%).
50
66 out of 128 total responses (52%).
51
63 out of 127 total responses (49.5%).
474
Q28. Would your organisation implement digital labelling if it were an option under the
revised regulations?
More than two-thirds of the industry stakeholders (94 out of 135) think that their
organisations would implement digital labelling if it were an option under the revised
regulations.
Q29. In your view, how should any label information presented via IT solutions be
organised?
The majority of the industry stakeholders (56%, 89 out of 156) would prefer a decentralised
database, operated individually by each manufacturer following standardised templates or
guidelines
Annex 13c - Legal Analysis (digital labelling)
This Annex provides a summary of existing labelling requirements under Classification,
Labelling and Packaging Regulation (CLP) and Detergents Regulations, including labelling
examples and the identification of duplications and legislative overlaps between different
pieces of EU legislation.52
The analysis of the relevant regulation, in conjunction with the exchanges incurred with the
Commission, also allowed the research team to define a “baseline” label53
to be used in the
behavioural experiment as described in Annex 4.
52
CLP, Detergents Regulation, Cosmetic Products Regulation and Biocidal Products Regulation.
53
The baseline label is a regulatory-compliant test label which will be tested in the experiment to assess the
behaviour and understanding of consumers of specific products (in this experiment detergents and glues) under
the currently applicable legislation.
10%
15%
9%
10%
10%
15%
20%
32%
20%
22%
41%
35%
24%
18%
22%
34%
22%
29%
30%
33%
42%
30%
22%
15%
15%
3%
8%
4%
5%
7%
0% 25% 50% 75% 100%
Managing different data formats
Managing changes in labelling processes
Implementing IT solutions
Increased costs associated with implementing
technological aspects
Increased costs associated with changes to design
/packaging
Increased costs associated with training
Not challenging at all A little challenging Neither challenging nor easy
Moderately challenging Extremely challenging
475
GENERAL OVERVIEW
Labelling obligations for substances and mixtures fall under the Classification, Labelling and
Packaging Regulation (Regulation (EC) No 1272/2008) in case a substance or mixture is
classified as hazardous.
The manufacturers, importers, downstream users (including formulators) and distributors
(including retailers) must label and package any hazardous substance or mixture before it is
placed on the market in accordance with Titles III and IV of the CLP (CLP Article 4(4))54
.
Following the rules of the CLP a substance or mixture contained in packaging must be
labelled in accordance with the CLP rules when:
the substance or the mixture itself is classified as hazardous; or
if it is a mixture containing one or more substances classified as hazardous above the
concentrations referred to in Part 2 of Annex II to the CLP, even if the mixture itself is not
classified overall as hazardous. In this case, the supplemental labelling as set out in Part 2 of
Annex II to the CLP applies (CLP Article 25(6)); and
if it is an explosive article as described in Part 2.1 of Annex I of the CLP.
The hazard classifications are set out in parts 2 to 5 of Annex I to the CLP. In general, there is
an obligation to classify substances and mixtures for their physical, health or environmental
hazards. Each class includes one or more hazard categories. For example, explosives,
flammable gases, flammable aerosols, and aerosols are classified under CLP Physical hazards
class. Some examples under Health hazards class are “acute toxicity”, “skin
corrosion/irritation”, “serious eye damage/eye irritation”, “respiratory or skin sensitisation”.
Under Environmental hazards class fall “Hazardous to the aquatic environment” and
“Hazardous to the ozone layer” classifications.55
The CLP is the primary basis for identifying hazards, providing hazard classification across
almost all other pieces of EU legislation as well as labelling and other risk and hazard
communication measures. The aim of the CLP is that consumers56
, industrial57
and
professional users58
should be provided with relevant and adequate information that allows
them to recognise the real hazard of a product and get relevant safe use guidance.
The labelling requirements of the Detergents Regulation is the primary means by which the
Regulation aims to achieve its objective of ensuring the protection of human health. The
information included in detergents labels serves as a means of communicating information on
the content of detergents59
(e.g., fragrance allergens, enzymes, disinfectants, optical
54
‘Where a substance or mixture is classified as hazardous, suppliers shall ensure that the substance or mixture is
labelled and packaged in accordance with Titles III and IV, before placing it on the market.’
55
The Hazard class table, available at https://www.reach24h.com/en/service/chemical-service/eu-clp.html
provides full information for all CLP Hazard Classes and Categories.
56
The consumer is a member of the general public who may primarily be exposed to hazardous substances or
mixtures by using a consumer product.
57
Industrial users – people involved in manufacturing, handling and/or packaging of actives or products in
industry.
58
Professional users – people using end-products outside industry.
59
There are eighteen specific constituents listed in the Annex VII A to the Detergents Regulation, which must be
stated on the label if present as a constituent in the detergent at greater than 0.2% by weight for example all
surfactant types, phosphates and aliphatic hydrocarbons.
476
brighteners, perfumes, and preservation agents) and use instructions to consumers thus
allowing them to make more informed choices.
Whether a particular product falls within the scope of the Detergents Regulation depends on
its purpose (cleaning function or not) and not on its composition (containing surfactants or
not).60
Further, the labelling of ingredients according to the Detergents Regulation is not
dependent on whether these ingredients are hazardous or non-hazardous.
The labelling and packaging of all detergent products (i.e., both those intended for consumer
use and those intended for professional and industrial use) must comply with the requirements
of the Detergent Regulation. All detergent products which are classified as hazardous must
be hazard labelled in accordance with CLP. Where the detergent has a biocidal function61
or contains a preservation agent, the packaging must also contain labelling information as
required by the Biocidal Products Regulation (BPR)62. In addition, the Detergents
Regulation makes reference to the Cosmetics Products Regulation (CPR)63
for the labelling of
allergenic fragrances64.
Labelling elements under CLP Regulation
Under the CLP (Article 17(1)) in case a substance or mixture is classified as hazardous the
mandatory pieces of information the label has to provide to users are:
identification and contact details of the supplier(s);
the quantity of hazardous substance/mixture (on the label or on the package), and
the product identifier.
Depending on the hazard severity (hazard category) the label may include:
 hazard pictograms;
 signal words;
 precautionary statement; and
 a section for supplemental information:
60
Questions and agreed answers concerning the correct implementation of Regulation (EC) No 648/2004 on
detergents, 6.1 Criteria for deciding whether a product falls within the scope of the Regulation, p. 11. Available
at: https://ec.europa.eu/docsroom/documents/33168/attachments/1/translations/en/renditions/pdf
61
A biocidal function, by analogy with the definition of a biocidal product, means the function of destroying,
deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful
organism by any means other than mere physical or mechanical action. CA-Sept13-Doc.5. i.e., “Note for
guidance Subject: Frequently asked questions on treated articles”, answer to Q. 10, p. 6. Available at:
https://circabc.europa.eu/sd/a/d7363efd-d8fb-43e6-8036-5bcc5e87bf22/CA-Sept13-
Doc%205.1.e%20%28Rev1%29%20-%20treated%20articles%20guidance.doc
62
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the
making available on the market and use of biocidal products. Available at https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=celex%3A32012R0528
63
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on
cosmetic products, available at https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32009R1223
64
According to Annex VII A of the Detergents Regulation, the allergenic fragrances as listed by the 7th
amendment (2003/15/EC) of Directive 76/768/EEC shall be mentioned on the label if they have been added to
detergents sold to the general public at concentrations exceeding 0.01% by weight. This list of allergenic
fragrances, to be found in Annex III, Part 1 of Regulation (EC) No 1223/2009 can be adapted to technical
progress.
477
 obligatory: information which comprise of hazard statements provided
for in other parts of the CLP 65
and/or taken over from previous
chemical legislation, e.g., EUH001 Explosive when dry and EUH204
“Contains isocyanates. May produce an allergic reaction”; and
 non-obligatory: not part of the legal labelling requirements under CLP,
for example, instructions for use. Such information must not distract
from nor contradict the obligatory label elements and statements, for
example “non-toxic” or “non-polluting” must not be used;
a Unique Formula Identifier (UFI66
), if applicable, must also be added to, i.e., printed
on or affixed to, the label of mixtures falling under the scope of Article 45 and Annex
VIII to the CLP on poison centres.
The CLP implements the use of the hazard statements, precautionary statements, and
pictograms provided for by the United Nations Globally Harmonised System (GHS). The
CLP also includes the use of the two GHS signal words “Danger” and “Warning” to indicate
the severity of a hazard.
Section 1.2 of Annex I to CLP defines the label size, setting out minimum dimensions for the
label, with the pictogram size being linked to these minimum dimensions. Nevertheless, the
label should be large enough to contain all the label elements defined by the CLP while
remaining legible. As a result, the label may need to be larger than the minimum area
specified. The table below demonstrates the minimum dimensions of labels and pictograms
under the CLP. The size of the pictogram relates here to the dimensions of the pictogram
itself, and not to the size of the virtual square into which the pictogram is placed.
Table 156: Minimum dimensions of labels and pictograms under the CLP Regulation67
Capacity of the package Dimensions of the label
(in millimetres) for the
information required by
CLPArticle 17
Dimensions of the
pictogram (in
millimetres)
≤ 3 litres If possible, at least 52 x 74 Not smaller than 10 x 10
If possible, at least 16 x 16
> 3 litres but ≤ 50 litres At least 74 x 105 At least 23 x 23
> 50 litres but ≤ 500 litres At least 105 x 148 At least 32 x 32
> 500 litres At least 148 x 210 At least 46 x 46
The CLP requires that the label elements as referred to in CLP Article 17(1) be of such size
and spacing as to be easily read68
. Readability is determined by the combination of font size,
letter spacing, spacing between lines, stroke width, type colour, typeface, width-height ratio of
65
For example, the listing of surfactants and perfumes according to the Regulation (EC) No 648/2004 on
detergents, as amended; the authorisation number of the biocidal product according to the Biocidal Products
Regulation (EU) No 528/2012.
66
Mixtures for consumer or professional use must be submitted before 1 January 2021. Mixtures for industrial
use are due three years later, by 1 January 2024.
67
Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008, Version 4.2, March
2021.
68
CLP, Article 31(3) The label elements referred to in Article 17(1) shall be clearly and indelibly marked. They
shall stand out clearly from the background and be of such size and spacing as to be easily read.
478
the letters, the surface of the material and significant contrast between the print and the
background69
.
The exact size of the letters of the signal words, hazard statements, precautionary statements
and any supplemental information is not further defined in the legal text, i.e., it is up to the
supplier to determine the size of the letters that allows the label elements to be easily read.
However, the minimum letter size of 1.2 mm (‘x-height’) can be used as a reference70
. A
supplier may decide whether to increase the letter size with the overall volume of the
packaging and dimensions of the label, or to fix it more or less for all volumes and labels.
Similarly, a supplier may decide whether to have larger letter sizes for certain label elements
while others are presented in smaller letters71
.
The labelling elements described above must be clearly and indelibly marked on the labels.
The labels should be firmly affixed to one or more surfaces of the packaging immediately
containing the hazardous substance or mixture (CLP Article 31). They should be readable
horizontally when the package is set down normally.
A label may accommodate more language(s) than those required by the Member State where
the substance or mixture is placed on the market. As long as the label complies with the
(minimum) dimensions set out in Table 2 above and as long as legibility of the text elements
is warranted, the decision on the number of languages is at the discretion of the respective
supplier.
All hazard statements must appear on the label unless there is obvious duplication or
redundancy. The colour and presentation of the labels must allow the hazard pictogram and its
background to be clearly visible. Hazard pictograms are the shape of a square set at a point
(diamond shape) and must have a black symbol on a white background with a red border
(section 1.2.1 of Annex I to CLP). The CLP links the size of the hazard pictograms to the
minimum dimensions of the label. Each hazard pictogram should cover at least one fifteenth
of the minimum surface area of the label, but the pictogram area for the smallest capacity of
the package should be at least 16 mm x 16 mm, if possible, but must never be less than 1cm2
.
It is important to note that in order to reduce the number of substance (‘chemical’) names
on the label, no more than four names should be provided on the label for a mixture, unless
necessary due to the nature and severity of the hazards72
. If the trade name or the designation
of the mixture already includes the name(s) of the substance(s) contributing to the
classification of the mixture as defined in paragraph 3(b) of CLP Article 18, they do not need
to be repeated. Moreover, if the supplemental information on the label already contains
the chemical name of the substance, e.g., in the list of allergens and preservatives
required by Regulation (EC) No 648/2004 on detergents, it is advisable to use the same
name73.
69
Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008, Version 4.2, March
2021.
70
Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008, Version 4.2, March
2021, p.45.
71
Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008, Version 4.2, March
2021.
72
CLP, Article 18 (3)
73
Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008, Version 4.2, March
2021.
479
Article 32 of CLP provides some limited rules defining the location of information on the
label. However, further details as to how label elements are arranged are left to the discretion
of the person responsible for compiling the label. As a general rule, the information should be
structured in a way that is easy to read and understand or in other words the labels may be
organized in any way that leads to best clarity. However, the hazard pictograms, signal
word, hazard statements and precautionary statements should be kept together on the
labels. The supplier may decide the order of the hazard and precautionary statements.
Normally it is required to group them together on the label by language (CLP Article 32). In
case more than one language is used on the label, the hazard and precautionary statements of
the same language should be treated as one package and grouped together on the label. This
should allow the reader to find all relevant hazard and safety information in one place.
480
Table 157: CLP labelling requirements versus discretion of the supplier
CLP requirement (Article 32) Example of decision left to the discretion of
the supplier
The hazard pictograms, signal word, hazard
statements and precautionary statements must
be kept together on the label.
The supplier is free to choose the
arrangement of the pictograms.
Hazard statements must be grouped together
on the label.
The supplier may choose the order of the
hazard statements.
The supplier may choose whether these
groups are to be presented on the left, on the
right or elsewhere on the label.
Precautionary statements must be grouped
together on the label.
The supplier may choose the order of the
precautionary statements but should ensure
that they are grouped with the hazard
statements.
The supplier may choose whether these
groups are to be presented on the left, on the
right or elsewhere on the label.
In case more than one language is used on the
label, the hazard and precautionary
statements of the same language must be
grouped together on the label.
Where the supplier needs to use alternative
means to meet the requirements of CLP
Article 31 in relation to the language(s)
required in a particular Member State, he may
choose whether to accomplish this using fold-
out labels, tie-on tags or on an outer
packaging, in accordance with section 1.5.1
of Annex I to CLP.
Any supplemental information as referred to
in CLP Article 25 must be included in the
section for supplemental labelling and placed
alongside the label elements referred to in
CLP Article 17(1)(a)–(g).
The supplier may choose how to visibly
separate this section from the section
containing the label elements referred to in
CLP Article 17(1)(a)-(g). He may also decide
to place this information in more than one
location on the label.
The label elements must be easily readable
(Article 31(3)).
It is recommended to keep full sentences
together and in one line, if possible. The font
size and spacing must be large enough and in
relation to the dimensions of the label.
Principles of precedence
For hazard pictograms
Where the classification of a substance or mixture would result in more than one pictogram on
the label, rules of precedence are applied to reduce the number of pictograms required (CLP
Article 26). As a general rule, the label must include those pictograms which indicate the
481
most severe hazard category of each hazard class. This would also apply in case a
substance has both harmonised74
and non-harmonised75
classifications (CLP Article 26(2)).
In case a substance or mixture is assigned the supplemental hazard statement EUH071
(“Corrosive to the respiratory tract”), a corrosivity pictogram (GHS05) may be assigned (see
Note 1 of Table 3.1.3 in Annex I to CLP). Where this is done, the pictogram GHS07
(exclamation mark) for specific target organ toxicity SE category 3 (“Respiratory tract
irritation”) must be omitted from the label, as well as the hazard statement H335 (“May cause
respiratory irritation”).
For hazard statements
If a substance or mixture is classified within several hazard classes or differentiations of a
hazard class, all hazard statements resulting from the classification shall appear on the label,
unless there is evident duplication or redundancy (CLP Article 27). For example, if the hazard
statement H314 (“Causes severe skin burns and eye damage”) is assigned, H318 (“Causes
serious eye damage”) may be omitted. Similarly, if the hazard statement H410 (“Very toxic to
aquatic life with long lasting effects”) is assigned, H400 (“Very toxic to aquatic life”) may be
omitted.
Duplication or redundancy should also be avoided for a substance or mixture that is assigned
the supplemental hazard statement EUH071 “Corrosive to the respiratory tract”. In this case,
the hazard statement H335 (“May cause respiratory irritation”) for STOT SE category 3
(“Respiratory tract irritation”) should be omitted from the label.
For precautionary statements
Not more than six precautionary statements shall appear on the label, unless more are
necessary to reflect the severity of the hazards. To provide flexibility in the application of
precautionary phrases, combinations or consolidations of precautionary statements are
encouraged to save label space and improve readability. If the substance or mixture requires
labelling and is to be sold to the general public, the label must include one precautionary
statement on the disposal of the substance or mixture, as well as the disposal of the
packaging (CLP Article 28).
Exemptions from labelling and packaging requirements
In general substances and mixtures, especially those supplied to the general public, should be
supplied in packaging together with the necessary labelling information. Labelling
information and other relevant hazard information are provided through other means than a
label where unpackaged materials are supplied to professional users, usually in the Safety
Data Sheets (SDS). SDS are the main hazard communication tool aside from product labelling
74
Harmonised classification applies to substances only.
75
Under the CLP, a substance must be self-classified by manufacturers, importers or downstream users when it
has no harmonised classification in Annex VI to the CLP and it presents hazardous properties. This classification
and labelling information for the substances to be placed on the market is then notified by manufacturers and
importers to the Classification and Labelling Inventory (CLI) held by European Chemicals Agency. Mixtures
must always be self-classified before being placed on the market, as they are not subject to harmonised
classification and labelling.
482
required and regulated under REACH76
. Annex II of the Regulation sets out detailed
information which must be provided in a SDS under 16 required headings.
In exceptional circumstances, substances and mixtures may also be supplied to the general
public unpackaged. In case the substance or mixture is listed in Part 5 of Annex II to CLP
(currently only cement and concrete in the wet state), a copy of the labelling elements is
always required, for example on an invoice or bill (CLP Article 29(3), Part 5 of Annex II to
CLP).
Small packages where the contents do not exceed 125 ml
CLP Article 29(1) and section 1.5.1 of Annex I to CLP provide derogations for a packaging
that is so small or in such a shape or form that it is impossible to meet the requirements of
CLP Article 31 (General rules for the application of label). In this case the label elements may
be provided in one of the following ways: (a) in fold-out labels; (b) on tie-on tags; or (c) on an
outer packaging. The label on any inner packaging shall contain at least hazard pictograms,
the product identifier and name and telephone number of the supplier of the substance or
mixture.
The hazard statements and the precautionary statements linked to hazard categories may be
omitted from the label elements 1) where the contents of the package do not exceed 125 ml
and 2) the substance or mixture is classified in one or more of 17 hazard categories (section
1.5.2.1.1. of Annex I to CLP). Amongst them fall “Skin irritation” of category 2 and “Eye
irritation” of category 2.
The pictogram, the signal word, the hazard statement, and the precautionary statement linked
to hazard categories may be omitted from the label elements where 1) the contents of the
package do not exceed 125 ml and 2) the substance or mixture is classified as “Corrosive to
metals” hazard categories.
The label elements may be omitted from soluble packaging intended for single use where 1)
the content of each soluble packaging does not exceed a volume of 25 ml; 2) the
classification of the contents of the soluble packaging is exclusively one or more of the hazard
categories in 1.5.2.1.1 (b), 1.5.2.1.2 (b) or 1.5.2.1.3 (b); and 3) the soluble packaging is
contained within outer packaging that fully meets the requirements of Article 17 CLP.
The label elements may be omitted from the inner packaging where 1) the contents of the
inner packaging do not exceed 10 ml; 2) the substance or mixture is placed on the market for
supply to a distributor or downstream user for scientific research and development or quality
control analysis; and 3) the inner packaging is contained within outer packaging that meets
the requirements of Article 17 CLP.
The below figure presents an example of hazard label for supply to general public
demonstrating the required elements according to the CLP.
Figure 89: Example of Hazard Label for Supply77
76
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a
European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No
793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC.
483
Labelling of Detergents
The labelling of detergents follows three separate regulations: Detergents Regulation
648/2004, CLP Regulation 1272/2008 and Biocidal Products Regulation 528/2012.
A difference exists in the terminology regarding the hazard communication in form of
labelling between CLP and the labelling requirements of Detergents Regulations. The CLP
refers to a label on the packaging, while Detergents Regulation refers to information that
has to appear on the packaging78. The CLP Regulation, Article 17(1) states that if a
substance or mixture is classified as hazardous (and contained in packaging), the label shall
include the elements described in letters (a) to (h). The Detergents Regulation, Article 11(2)
elaborates the information that must appear on the packaging in which the detergents are put.
However, the different terminology does not have any impact or consequences on the
labelling of detergents and the communication of the relevant and adequate information to
consumers, allowing them to recognise the real hazard of a product, get relevant safe use
guidance and make more informed choices.
The labelling information on the packaging of detergents that are put up for sale to consumers
include:
77
Source: Hazard Labelling & Packaging according to the CLP Regulation Information Sheet. Available at
https://www.hsa.ie/eng/Publications_and_Forms/Publications/Chemical_and_Hazardous_Substances/CLP_info_
sheet.pdf
78
Support to the Evaluation of Regulation (EC) No 648/2004 (Detergents Regulation), p. 72. Available at:
https://op.europa.eu/en/publication-detail/-/publication/ad2fa114-e952-11e8-b690-01aa75ed71a1
484
A section dedicated to the CLP Regulation labelling requirements and elements;
A section for the additional labelling information according to the Detergents
Regulation; and
A section for the labelling requirements of the Biocidal Products Regulation, where
relevant79
.
In particular, the section related to the Detergents Regulation includes the following:
the name and trade name of the product;
the name or trade name or trademark and full address and telephone number of the
party responsible for placing the product on the market;
the address, email address, where available, and telephone number from which the
ingredient datasheet can be obtained80
;
a list of specific constituents if present in concentrations >0.2% in the product e.g.,
phosphates, aliphatic hydrocarbons. A weight percentage range must be provided;
names of any enzymes, disinfectants, perfumes, optical brighteners, preservatives
irrespective of the concentration in which they are found in the product;
names of any allergenic fragrances (as listed in Annex III of the Cosmetics Products
Regulation)81
;
the indication of instructions for use and special precautions;
dosage instructions82
;
website of the manufacturer where the ingredient datasheet is available83
.
Detergents might also contain voluntary information (not required under different EU pieces
of legislation) such as safe use icons and phrases. The International Association for Soaps,
Detergents and Maintenance Products (A.I.S.E) has developed a set of safe use icons
complemented with related sensible advice text in order to improve and further develop clear
messages for consumers on how to use A.I.S.E. consumer products84
. These safe use icons
and phrases intend to help the consumers to use and store household detergents and
maintenance products safely. They can be found on the label and provide safe use instructions
in a simple and user-friendly way85
. In addition, there are voluntary icons and tips providing
information to consumers how to clean more sustainably saving water, energy, CO2 and
money.86
The Guidance on Labelling and Packaging in accordance with Regulation (EC) No 1272/2008
(Version 4.2 – March 2021)87
provides an example of a single language label for a mixture
79
For detergents disinfectants and detergents that are also treated articles and which fulfil the labelling
requirements of BPR.
80
Detergents Regulation, Article 11.
81
If present at greater than 0.01% by weight (or at a replacement limit), for example Citral, d-Limonene, Oak
moss and tree moss extract and Linalool.
82
The packaging of consumer laundry detergents and consumer automatic dishwasher detergents shall bear the
information provided for in section B of Annex VII to Detergents Regulation.
83
“The website address, from which the list of ingredients mentioned in section D of Annex VII can be obtained,
shall be given on the packaging.” Annex VII A to Detergents Regulation as amended by COMMISSION
REGULATION (EC) No 907/2006 of 20 June 2006 amending Regulation (EC) No 648/2004 of the European
Parliament and of the Council on detergents, in order to adapt Ann exes III and VII thereto. Available at
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32006R0907
84
https://www.aise.eu/documents/document/20140129161815-
final_draft_aise_safe_use_guidelines_revjan2014.pdf
85
https://www.cleanright.eu/en/safe-use.html#safe-use
86
Such examples can be found at https://www.cleanright.eu/en/sustainable-use.html
87
https://echa.europa.eu/documents/10162/23036412/clp_labelling_en.pdf
485
containing both obligatory and non-obligatory supplemental information (supplied to the
general public). The example label given below illustrates the supply and use label for a
typical consumer product (detergent).
All obligatory labelling information is shown, i.e., the product identifiers (trade name and
designation of the mixture; one of them would have been sufficient), the identity of the
supplier, the signal word, the UFI code, the hazard and precautionary statements in
accordance with CLP and the obligatory supplemental information, in accordance with
Detergents Regulation. The supplemental labelling information according to the CLP is
grouped together. The UFI can alternatively be placed outside the label (e.g., printed or
affixed on the inner packaging) but in proximity to the other obligatory CLP label elements.
As the product is supplied to the general public, its nominal quantity is also provided on the
label. Beyond the obligatory supplemental information, also non-obligatory supplemental
information is shown. The non-obligatory supplemental labelling information, the content of
which is at the discretion of the supplier, is not part of the labelling requirements under the
CLP88
. No P-statement on disposal is given as this is not required for a mixture classified as
eye irritant.
The label shown is primarily drafted for inner packaging. If the chemical is contained in
combination (= inner + outer) packaging, the same information has to be shown on the outer
packaging, unless the information on the inner packaging can be seen through the outer
packaging.
88
Suppliers may need to include certain elements on the label that are not obligatory but are necessary for the
handling and use of the product, for example specific product information, basic instructions for use or P-
statements that do not arise directly from the classification of the product (e.g., “Read label before use” or “Do
not get in eyes” for eye irritant mixtures).
486
Figure 90: Example of detergent label. Hazard class “Eye Irritation”89
The below figure presents an example of the regulatory requirements according to CLP and
Detergents Regulations for a product bleaching detergent supplied to the general public
(consumers). The text in the pink boxes relates to the labelling elements required for
89
Guidance on Labelling and Packaging in accordance with Regulation (EC) No 1272/2008 (Version 4.2 –
March 2021); p. 63.
487
detergents under CLP while the text in the yellow boxes relates to information requirements
under Detergents Regulation.
Figure 91: Example of detergent label. Hazard class “Serious eye damage/skin irritation”90
Detergents labelling under Biocidal Products Regulations
There are two types of detergents falling under the scope of Biocidal Products Regulations:
detergents that are also disinfectants (biocidal products) and detergents containing an in-can
90
HSA Detergent Labelling & Packaging Requirements, available at:
https://www.hsa.ie/eng/Your_Industry/Chemicals/Legislation_Enforcement/Detergents/Detergent_Labelling_Pa
ckaging_requirements/
488
preservative91
(treated articles), both subject to different definitions and different labelling
provisions. The rules apply to both laundry and dishwasher detergents as well as other
detergent types, covering detergents for consumer, professional and industrial use.
Article 3.1(a) of BPR defines as ‘biocidal product’ any substance or mixture of it “capable of
preventing the action” or carrying out a control action on any harmful organism by any means
other than mere physical or mechanical action. In brief, biocides are products that destroy
harmful organisms through chemical/biological processes.
Article 3.1(l) of BPR defines ‘treated article’ as “any substance, mixture or article which has
been treated with, or intentionally incorporates, one or more biocidal products.” The
definition refers to the explanation of biocidal product in Article 3.1(a) of BPR and it is
important to note that the definition of a biocidal product indicates that: a treated article that
has a primary biocidal function shall be considered a biocidal product. A liquid laundry
sanitizer (with a biocidal claim e.g., kills bacteria) is an example of a treated article with
primary biocidal function.
In addition to the requirements specified in the Detergent Regulation the labelling information
on the packaging of detergents that contain biocidal active substance/s92
(e.g., disinfectant,
antimicrobial or sanitising product) should contain all the relevant elements specified in
Article 69 of the BPR. The label of a detergent that is also a biocide namely with a biocidal
function such as antibacterial, antimicrobial, antifungal, sanitizing, and disinfectant etc. “must
show clearly and indelibly the following information”:
 the name(s) of the biocidal active ingredient(s) and its concentration in the product93
;
 the notification or approval number (e.g., PCS 9xxxx or IE/BPA 7xxxx)94
. Only
notified or approved biocides have such a number;
 the type of product formulation95
;
 what the product is approved for96
;
 the formulation batch number or designation and the expiry date relevant to normal
conditions of storage97
;
 details of any restricted users i.e., for general public or professional/industrial use
only98
;
 instructions on handling, storage, application, use and disposal of the biocide99
;
 details of any protective clothing or equipment which must be worn when using the
biocide; and
 whether access to treated areas needs to be restricted100
.
91
Used to preserve water-based formulations such as laundry detergents, surface cleaners, hand dish washing
liquids, etc…
92
Biocidal substances are incorporated into detergents to give them antibacterial, antimicrobial, disinfecting or
sanitizing properties with the intention to destroy, make harmless or control harmful organisms such as bacteria
or viruses by means other than mere physical or mechanical action.
93
BPR, Article 69 (2) (a) the identity of every active substance and its concentration in metric units;
94
BPR, Article 69 (2) (c) the authorisation number allocated to the biocidal product by the competent authority
or the Commission;
95
BPR, Article 69 (2) (e) the type of formulation;
96
BPR, Article 69 (2) (f) the uses for which the biocidal product is authorised;
97
BPR, Article 62 (2) (k);
98
BPR, Article 69 (2) (m) where applicable, the categories of users to which the biocidal product is restricted;
99
BPR, Article 69 (2) (g), (j),
100
BPR, Article 69 (2) (l).
489
The figure below presents the information that must be contained on the package of a
detergent that is also a biocide. The text in the green boxes relates to the information
requirements for biocidal detergent products (BPR), the text in the pink boxes relates to the
labelling elements required for detergents under CLP while the text in the yellow boxes
relates to information requirements under Detergents Regulation.
490
Figure 92: Example of the information that must be contained on a Detergent package containing a Biocide101
A laundry liquid detergent formulated with an in-can preservative102
having a preserving
function103 in the final product is an example of a detergent that is also a treated article in
accordance with BPR.
101
https://www.hsa.ie/eng/Publications_and_Forms/Publications/Chemical_and_Hazardous_Substances/Detergen
ts_Info_Sheet.pdf
102
For example, under the brand names vinkocide, grotan®, grotanol®, parmetol®.
103
A preservative's function is to ensure that products are safe to be used by consumers over a long period of
time and to maintain the appearance of the product.
491
According to the Commission guidance on treated articles104
, detergents, containing an
additive, which had an in-can preservative added in order to protect it during storage, where
this preservative has no further preserving function in the final product are not
considered as treated articles and are not a subject to the BPR labelling provisions listed in
Article 58(3). According to the same guidance document detergents, containing what are
often referred to as “carry over” preservatives i.e., preservatives that were not added by the
manufacturer as such but by a supplier to protect a specific ingredient used for the formulation
of a detergent) and which are found in the detergent in very small concentrations are also not
subject to BPR labelling provisions. However, Annex VII A of the Detergents Regulation
stipulates that “if added, preservation agents shall be listed, irrespective of their
concentration”. Thus, even if under BPR some treated articles might not be labelled, under the
Detergents Regulation they would always be labelled irrespective of the concentration in
which they are added in the detergent.
In case the treated articles for which the active substance meets the criteria to be classified as
a skin sensitizer category 1 or sub-category 1A in accordance with CLP, the provisions of
BPR Article 58(3) should apply105
. This specific labelling provision will be imposed through
the substance approval decision.
The requirements for labelling information for treated articles placed on the market are
elaborated in BPR Article 58(3) and are different from the information the label of biocidal
product must show106
. Treated articles have to be labelled according to Article 58(3) in case
that:
 A claim is made about the biocidal properties of the treated article e.g., biocide is
added intentionally, with claim and/or market positioning regarding its biocidal
properties gained from using biocides (e.g., mould resistant polish);107
 When the conditions associated with the approval of the active substance concerned
require specific labelling provisions.
The label of the placed on the market detergent product (in case of treated articles) must
provide:
a statement that the treated article incorporates biocidal products;
the biocidal property attributed to the treated article, where substantiated;
the name of all active substances contained in the biocidal products;
the name of all nanomaterials contained in the biocidal products, followed by the word ‘nano’
in brackets108
;
any relevant instructions for use, including any precautions to be taken because of the biocidal
products with which a treated article was treated or which it incorporates109
.
104
Appendix 1; Commission note on guidance on treated articles, CA-Sept13-Doc.5. I.e., (Revision 1, December
2014).
105
Commission note CA-May15-Doc.6.1-Final.
106
BPR, Article 69.
107
It should be pointed out that the majority of ‘regular/ normal’ detergents & cleaning products are not subject
to this requirement.
108
Preservatives for products during storage PT6 biocidal products are very unlikely to contain nanomaterials.
492
Identified overlaps, duplications, and inconsistencies
As mentioned in the previous section legal analysis shows a difference in the terminology
regarding the hazard communication in form of labelling between CLP and the labelling
requirements of Detergents Regulations. The Detergents Regulation refers to placing
information “on the packaging” of the detergent product (e.g., Article 11(2)), while CLP
refers to placing information “on the label”. However, no evidence has been found for any
practical consequences or impact of the different terminology on the hazard communication to
consumers, professional or industrial users.
The Detergents Regulation is clear on the fact that its labelling provisions are “without
prejudice” to the provisions of the CLP, i.e., they come in addition to CLP requirements. For
example, where applicable110
, the section containing the labelling elements dedicated to the
CLP might include on the label hazard pictograms, signal words, hazard statements and
precautionary statements that, to some extent, overlap with Article 11(3) of the Detergents
Regulation specifying that “the packaging of detergents shall indicate […] instructions for use
and special precautions, if required”.
In practice, the compliance with the labelling provisions of CLP (hazard pictograms, hazard
statements, precautionary statements, etc.) has as an effect to, in part, fulfil the requirements
of the Detergents Regulation, Article 11(3), although this is not explicitly stated in the legal
text of the Regulation. It might be noted that the CLP and Detergents Regulation complement
each other in the sense that both Regulations aim to protect the health of consumers, industrial
and professional users 111
. If a substance is regulated or presents a hazard, then there are
standard phrases under CLP that can be used to warn consumers, industrial and professional
users.
Detergents Regulation, Article 9(3) obliges manufacturers placing on the market the mixtures
covered by this Regulation to make available, upon request, without delay and free of charge,
to any medical personnel, an ingredient datasheet as stipulated in Annex VII C112
. For
mixtures (such as detergents, paints, and household chemicals) subject to submission
requirements under Article 45 and Annex VIII to CLP, a unique formula identifier (UFI) must
be provided. The poison centres can identify the exact product and its composition through
the submitted UFI. In this regard there is a duplication between these requirements in the
sense that the ingredient data sheet under the Detergents Regulation serves a similar purpose
as the harmonised information provided to poison centres under the Annex VIII to the CLP.
Further, a certain inconsistency exists between the Detergents Regulation and REACH
regarding the information that needs to be included in the safety data sheet for industrial and
institutional detergents. This inconsistency results from the fact that the safety data sheet is
compiled in accordance with the requirements stipulated in REACH, which are different from
the labelling requirements of the Detergents Regulation.
109
The CLP Regulation requirements for informing and warning users about potential hazards and related
precautions to be taken - for example H317 “May cause an allergic skin reaction” and EUH 208 “Contains …
May produce an allergic reaction”.
110
If a substance is regulated or presents a hazard.
111
COMMISSION STAFF WORKING DOCUMENT Evaluation of Regulation (EC) No 648/2004 of the
European Parliament and of the Council of 31 March 2004 on detergents.
https://ec.europa.eu/docsroom/documents/36289
112
Annex VII C requires “The common chemical name or IUPAC name, the CAS number, and, where available,
the INCI name, and the European Pharmacopoeia name, shall be given for each ingredient”. However, this
requirement only applies for the ingredient datasheet (to be provided on request).
493
The listing of allergens (fragrances and preservatives) “on the packaging” of the detergent
product aims to protect and inform all end-users on hazards, including those already
sensitized. The Evaluation of Regulation (EC) No 648/2004 of the European Parliament and
of the Council of 31 March 2004 on detergents113
reveals some legislative overlaps between
the Detergents Regulation and the CLP with regard to the labelling of allergenic fragrances.
Other overlaps also exist e.g., on the labelling of surfactants114
and allergenic preservatives
when CLP thresholds are met.
Under CLP, ingredients that present a chemical hazard should be included on the product
label using the chemical name (e.g., MEA-dodecylbenzene sulfonate), whereas under the
Detergents Regulation ingredients can be listed under a generic name (e.g., anionic
surfactant). Complying with the labelling requirements of both Regulations results in the
labelling of the same ingredient twice, and in some cases using different names.
In the public consultation of 2014 the Commission proposed, among others, to Amend Annex
III to the CPR (‘List of substances which cosmetic products must not contain except subject to
the restrictions laid down’) by submitting additional 62 contact allergens to the obligation of
individual labelling, in addition to the 25115
allergens already listed in Annex III. Should the
Commission introduce the obligation to label additional 62 fragrance ingredients the number
of fragrance allergens to be labelled would increase to 87 substances. The labelling of
additional fragrance allergens will have an impact on products regulated by the Detergents
Regulation116
resulting in more allergens being listed on the packaging.
The Detergents Regulation requires the label to include the allergenic fragrances listed in
Annex III to the CPR and which are added to detergents at concentrations exceeding 0.01%
by weight on detergents’ labels. The labelling of these fragrances shall be done by using the
International Nomenclature of Cosmetic Ingredients ("INCI names")117
.
In parallel, the CLP requires the inclusion of skin sensitisers118
(i.e., allergenic substances like
preservatives and fragrances) in the list of ingredients that need to figure on the product label
when they are present above certain thresholds.119
These thresholds are different from the
113
Commission Staff Working Document Evaluation of Regulation (EC) No 648/2004 of the European
Parliament and of the Council of 31 March 2004 on detergents. Available at:
https://ec.europa.eu/docsroom/documents/36289
114
The word “surfactant” is an abbreviation of the phrase ‘surface active agent’. A surfactant is a chemical
compound that reduces the interfacial tension between water and other liquids such as fats and oils. Surfactants
are common ingredients in topical products, which can cause both irritant and allergic contact dermatitis.
115
One of the 26 allergens currently subject to labelling HICC (3 and 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-
ene-1-carbaldehyde) have been excluded from these calculations as it was banned by Regulation 2017/1410 of 2
August 2017. Transition periods for the ban end on 23 August 2019 (for placing the substance on the market)
and 23 August 2021 (for making it available on the market).
116
Inception impact assessment - Ares (2018)6241542. Available at: https://ec.europa.eu/info/law/better-
regulation/have-your-say/initiatives/2009-Labelling-fragrance-allergens_en
117
The International Nomenclature Cosmetic Ingredients (INCI) name is mandatory in the European Union (EU)
according to Regulation (EC) No 1223/2009 for labelling the names of ingredients on cosmetic products. Article
19(1)(g) of the Regulation requires the labelling information on cosmetic products to include a list of ingredients.
The ingredients are to be expressed using the common ingredient name set out in a glossary compiled and
updated by the Commission pursuant to Article 33 of that Regulation. The glossary takes account of
internationally recognised nomenclatures including the International Nomenclature of Cosmetic Ingredients.
Since 2004, the INCI system is mandatory in the EU for labelling of preservatives and allergenic perfume
ingredients according to the Detergents Regulation (EC) No 648/2004.
118
A skin sensitizer is "a substance that will induce an allergic response following skin contact".
119
Under CLP, skin sensitisers must be indicated on the label if added at concentrations exceeding 1.0% (skin
sensitiser Category 1), 0.1% (skin sensitiser Category 1A) and 1.0% (skin sensitiser Category 1B).
494
thresholds provided in the Detergents Regulation. As most allergenic fragrance ingredients
under the Cosmetic Products Regulation are also classified as skin sensitisers under the CLP
this may lead to the labelling of the same substance twice, once following the Detergents
Regulation and once following the CLP.
In addition to the different thresholds for the labelling of allergenic fragrances between the
Detergents Regulation and the CLP two more differences exist, namely:
The product identifier of the substance, i.e., the name (and identification number) under
which the allergenic fragrance is to be labelled, is different under these two Regulations: as
the Detergents Regulation refers to the Cosmetic Products Regulation for the labelling of
allergenic fragrances, the latter are listed on detergents' labels with their INCI name. Contrary
to that, the CLP requires that substances are labelled with either the name and
identification number given in Part 3 of Annex VI to the CLP Regulation120
or, in case the
substance is not part of the list of substances provided therein, with the name and
identification number given in the classification and labelling inventory. If neither of these
product identifiers exists, then the substance is labelled either with its CAS121
number
together with its IUPAC122
name or only the IUPAC name in case that the substance doesn't
have a CAS number. Finally, under certain conditions, substances can also be listed with their
EC names123
.
For mixtures not classified as sensitising but containing at least one skin sensitiser (e.g., an
allergenic fragrance) above a pre-defined concentration threshold, (as is commonly the case
for detergents), the CLP requires that a EUH208 statement124
is included in their label.
Based on the above it appears that one and the same allergenic fragrance contained in a
detergent is very likely to be indicated twice on the detergent's label and in some cases under
different names.
The example below demonstrates that there can be duplication between – on the one hand –
the product identifier of the mixture or EUH statement and – on the other hand – the
supplemental information mandated by the Detergents Regulation (i.e., the list of allergens
and preservatives, which may be referred to by an INCI name also included in the
Classification and Labelling Inventory).
Figure 93: Example of dual labelling of ingredients.
120
Part 3 of Annex VI to the CLP provides a table on the harmonised classification and labelling of hazardous
substances.
121
CAS Registry Number is a unique numerical identifier assigned by the Chemical Abstracts Service (CAS) to
every chemical substance described in the open scientific literature.
122
The IUPAC nomenclature of organic chemistry is a systematic method of naming organic chemical
compounds as recommended by the International Union of Pure and Applied Chemistry (IUPAC).
123
The EC number, i.e., EINECS, ELINCS or NLP, is the official number of the substance within the European
Union.
124
EUH 208 ‘Contains (name of sensitising substance). May produce an allergic reaction’.
495
It should be noted that three EU regulations guide the labelling of (sensitizing) preservatives:
the Detergents Regulation, BPR and CLP.
The Detergents Regulation requires information on the presence of preservative/s regardless
of the concentration and BPR requires information on the preservative/s used in the ‘treated
article’. The BPR requirement for the label to provide (in case of treated articles) the name of
all active substances contained in the biocidal products is already covered by the Detergents
Regulation labelling requirements: name of the in-can preservative(s) is listed on the label
(INCI name).
The CLP requires hazard statement for Induction H317 “May cause an allergic skin reaction”
and “(substance name)” or Elicitation EUH208 “Contains (substance name). May produce
an allergic reaction”. If a EUH statement needs to be included, then the same allergenic
fragrance is labelled thrice, i.e., twice under the CLP (product identifier + EUH statement)
and once under the Detergents Regulation.
The below figure is an example of a typical detergent label highlighting the duplication and
inconsistencies between CLP and Detergents Regulations125
.
125
The detergents regulation and opportunities to improve communication of safety information to consumers;
GIULIA SEBASTIO International Association for Soaps, Detergents and Maintenance Products (A.I.S.E.),
496
Figure 94: Typical Detergent Label and a Highlight of the Duplication and Inconsistency
497
Annex 13d – Overview of costs and benefits under
the preferred option
Overview of Benefits (total for all provisions) – Preferred Option
Description Amount Comments
Direct benefits
Improved consumer safety and label
readability
N/A Possibility to move supplemental
labelling information126
under CLP,
and labelling requirements127
under
the Detergents Regulation to digital
labels, would simplify the labels
overall and would improve the well-
being of consumers with visual
impairments.
Benefits for the manufacturers N/A Benefits for the manufacturers
include:
Better management of fast
changing label information,
and;
More space on physical
labels for multiple
languages which would
allow for more cost-
effective product
distribution across EU
markets.
Administrative cost savings related to the ‘one in, one out’ approach
Possibility to reduce the frequency of
changes in physical labels
N/A Currently, annual costs related to the
disposal of labels reaches around 1 %
of manufacturers’ annual turnover
with the frequency of disposing the
labels around 3-4 times per year.
Under Policy Option 3, these costs
would likely to be reduced, however,
quantification of such theoretical
reduction is not possible.
126
EUH statements as per sections 1.1. and 1.2. of Annex II (Art. 25(1)); Other supplemental labelling
information than that in paragraphs (1) and (2) of Art. 25 (Art. 25(3)); EUH statements as per Part 2 of Annex II
for certain mixtures (Special rules for supplemental label elements for certain mixtures, Art. 25(6)).
127
Detailed dosage instructions, with only simplified dosage instructions kept on pack; Some categories of
ingredients (e.g. surfactants) while other categories are kept on pack (e.g. enzymes, bleach); Other labelling
information such as the address and telephone number of the manufacturer.
498
Citizens/Consumers Businesses Administrations
Type of cost One-off Recurrent One-off Recurrent One-off Recurrent
Familiarisation
activities
N/A N/A N/A Three to four FTEs
who would need 10 to
20 working days to
conduct
familiarisation
activities (e.g.
training, consulting) at
the company level.
N/A N/A
Disposal of labels N/A N/A One-time cost of
disposing the labels to
comply with the new
regulatory
requirements under
Policy Option 3 is
estimated to reach
0.25% to 0.33% of
companies’ annual
turnover.
Currently, annual costs
related to the disposal
of labels reaches
around 1 % of
manufacturers’ annual
turnover with the
frequency of disposing
the labels around 3-4
times per year. Under
Policy Option 3, these
costs would likely to
be reduced, however,
quantification of such
theoretical reduction is
not possible.
N/A N/A
Enforcement
costs
N/A N/A N/A N/A N/A The information which
will be provided
digitally will not be a
point of compliance
check by the
authorities. Under
Policy Option 3, the
provision of a digital
label will be in
voluntary basis.
499
Annex 13e – Description of the analytical methods
used in preparing the impact assessment (digital
labelling)
This Annex provides a description of an approach to the prospective analysis whose results
are described in the main body of this report. The aim of the prospective analysis was to (1)
assess the problems identified and its drivers, provide the reasons for the EU action, set
general and specific objectives of the new initiative, develop policy options tackling these
objectives, assess the developed policy options in terms of their economic, social, and
environmental impacts and, finally, compare the policy options under effectiveness,
efficiency, and coherence criteria.
OVERVIEW OF THE METHODS
The prospective analysis was carried out between December 2021 and March 2022. The work
was structured around seven main tasks, each of them containing various activities. This part
summarises the work under the key evidence-gathering and analysis activities.
Problem Tree Definition
The definition of the problem and its problem tree were identified and refined based on
information collected at the Inception Phase of the study and discussions with the
Commission. The final version of the problem tree containing the key drivers behind the
problems identified and the consequences of these problems to the environment, consumers,
and the industry is presented in Chapter 2.
Subsidiarity analysis
Each of the key problems identified as part of the problem tree definition were carefully
assessed with respect to subsidiarity, more specifically, the necessity and added value of EU
action.
Policy Objectives Identification
Following the definition of the problems, and the necessity and added value of EU action, the
objectives of the policy action were defined, including the general objectives covered in this
study, namely:
CLP Regulation: to ensure a high level of protection of human health and the environment as
well as the free movement of chemical substances, mixtures and certain specific articles,
while enhancing competitiveness and innovation;128
Detergent Regulation: to achieve the free movement of detergents and surfactants for
detergents in the internal market while, at the same time, ensuring a high degree of protection
of the environment and human health.
And the specific objectives of this study, namely:
128
Recital 1 CLP Regulation.
500
 SO1: to improve consumer understanding and awareness of labels, by simplifying and
streamlining the existing labelling requirements in the Detergents regulation;
 SO2: to set up a future-proof regulatory framework allowing the use of digital tools to
communicate product information.
Definition of the policy options
The definition of the policy options started with defining the baseline policy option based on
a projection of the status quo. The definition of the baseline scenario involved understanding,
qualifying, quantifying, and monetising (to the extent possible) the key elements of the
current situation concerning the critical developments in the EU population, technological
uptake of consumers and enterprises and the size of the chemical industry in the EU.
Subsequently, the data collected combined with the results of the problem definition and the
opinions provided by stakeholders under targeted stakeholder consultation contributed to
refining the five policy options developed to tackle these objectives.
Assessment of the policy options
In alignment with the Better Regulation Toolbox, the first step in the assessment of impacts
was the identification of all relevant impacts under the different policy options. The
identification of the impacts was based on data and information collected during the previous
tasks (i.e. interviews, behavioural experiment, surveys, and analysis of OPC responses). The
research collected qualitative information and quantitative data on social, economic and
environmental impacts related to the identified policy options.
Socio-economic and environmental impacts identified were categorized according to the
following criteria:
 Economic impacts, in particular focusing on the conduct of business (BR Tools #21-
25), sectoral competitiveness, trade and investment flows (BR Tools #21, 27), impact
on the SMEs (BR Tool #21), technological development / digital economy (BR Tool
#28), and impact to public authorities (BR Tool #58);
 Social impacts, focusing on consumers and households (BR Tool #33);
 Environmental impacts, in particular focusing on sustainable consumption and
production (BR Tool #36).
The impacts that were taken into account for this analysis were considered to be the most
relevant and the ones for which consulted stakeholders were able to provide insights. A
dedicated survey targeting public authorities, consumer organisations and industry
representatives (associations and businesses) presented the individual policy options and
asked participants to provide direct feedback. The opinions of stakeholders were triangulated
with other data sources used in the study. The impacts were modelled in quantitative terms
(and monetary terms, whenever possible), and in qualitative terms. The modelling of the
impacts involved assessing each option against the baseline scenario, based on the expected
evolution of key external trends in the absence of any new policy measures.
501
Comparison of the policy options
As a final step of the impact assessment, after assessing the identified socio-economic and
environmental impacts of each policy option, policy options were compared under
effectiveness, efficiency, and coherence criteria.
Concerning the effectiveness criteria, policy options were assessed vis-à-vis the two specific
objectives of this study, and economic, social, and environmental impacts identified
previously. In the analysis, a comparison of the policy options vis-à-vis each specific
objective and socio-economic and environmental impact was illustrated in the following
method:
Table 158: Colour coding
Colour
coding
-- - O + ++ U
Qualitative
Strongly
negative
Weakly
negative
No or
limited
impact
Weakly
positive
Strongly
positive
Undefined
In terms of efficiency, the analysis consisted of two parts:
Presentation and comparison of monetizable costs and benefits identified in this study, and;
Presentation and comparison of stakeholder perception on the costs-benefits ratio under each
policy option.
In terms of coherence, the criteria used for the assessment of the policy options were:
Coherence between CLP and Detergents regulations;
Coherence with digitalisation trends in the economy and other EU level and international
initiatives on the topic;
Overall assessment of stakeholders’ opinion on the policy options.
Following the comparison of the options, the preferred policy option was selected, namely –
Policy Option 3: Revision of the labelling rules in the regulations, introducing optional digital
labelling: keep basic information of labelling requirements on physical labels, and move
certain labelling requirements on the digital label only.
LIMITATIONS ENCOUNTERED AND MITIGATION MEASURES
Limited availability of updated, EU-level, comparable quantitative data
The limitations of quantitative data were the most evident concerning data related to the
operational costs i.e. set-up and maintenance of systems supporting digital labelling. Using
this data in the assessment and comparison of the policy options would have been really
useful, in particular, for monetising the economic impact (conduct of business) and the
expected costs to the chemical industry under Policy Options 3, 4, and 5. The majority of the
consulted industry stakeholders mentioned that they do not have this information available
and the timeline to collect it at company level was too short. Furthermore, although, during
the targeted stakeholder consultation, businesses identified specific benefits of transferring
502
information from physical to digital labels, these potential benefits could not be estimated
quantitatively due to the wide range of variables affecting labels (e.g. size of the label,
number of ingredients, type of chemical product, etc.). The combination of these factors
resulted in a limited cost-benefit and cost-effectiveness analysis of the policy options that
include the use of digital labels.
Similarly, although consulted public authority stakeholders provided input concerning the
cost-benefit ratio for national authorities for each policy option, during the course of the
study, no concrete quantifiable data was found concerning, for example, additional FTEs
needed from public authorities under each policy option to perform enforcement and
monitoring activities. It is difficult to estimate the costs each policy option would include to
public authorities, especially considering the current lack of clarity on the digital
infrastructure that would be used to store the information on digital labels129
.
The analysis of impacts on consumers focused on assessing the impact on safety (i.e. safe use
of products) and label readability. The study gathered valuable qualitative input from the
targeted stakeholder consultation. However, the perception on these issues from stakeholders
representing consumers (i.e. consumer organisations) is not complete due to the lack of
responses from such stakeholders to the survey on the policy options. Nonetheless, data
triangulation and the use of other data sources (i.e. OPC, interviews, and behavioural
experiment) countered this problem to an extent.
Likewise, the assessment of the environmental impacts also was essentially qualitative and
focused on the impact on the awareness of consumers about the impacts of dispersion of
substances in the natural environment. Thus, the analysis did not include an estimate of waste
(i.e. disposal of waste) generated by regulatory changes. In this case, however, policy options
include, where relevant, long enough transition periods during which old labels and
packaging can be used to avoid costs for duty holders and the creation of waste. Hence,
quantitative estimation of the impact on the environment was considered not relevant.
In conclusion, the limitations on quantitative data constrained the strength of the argument on
the scale of some identified problems and implications of future policy options. In some
cases, estimations were corroborated by existing evidence underpinning the key assumptions
through alternative data. In addition, for some options where quantification of costs and
benefits was not feasible, a qualitative approach was chosen instead.
The low response rate from consumer stakeholders regarding the survey on policy
options
Response rate across all consultation activities, across all major stakeholder categories
(industry, public authority, and consumers) was high. Hence, the findings from these
activities can be considered, overall, representative. Nonetheless, the most important source
of data for the impact assessment part – the online survey on the policy options, had
limitations in terms of representativeness. This is particularly the case for stakeholders
representing consumers, and, to a lesser extent, public authorities. The survey received a
significant number of responses from industry stakeholders (n=67), but a relatively small
number from public authorities (n=13), and an insignificant number of responses from
consumer organisations (n=2). The low number of responses from consumer organisations
129
Possible options would include EU centralised database of e-labels held by EU wide public
authority/provider; EU centralised database of e-labels held by third-party provider; Independent providers of e-
label services (EU or national); Manufacturers' websites with e-labels of own products.
503
resulted in an overall lower level of representation of consumers in terms of assessing the
impact on consumer safety (i.e. safe use of products), and label readability. To counter this
issue, other sources of data (i.e. OPC, interviews, and the behavioural experiment) were used
to add to overall representativeness.
Several factors explain the low response rate from consumer stakeholders consulted for this
study, notably: the timeline of the assignment, the overlap with other consultation activities
on the same topic (i.e. interviews, behavioural experiment, public consultation), resulting in
stakeholder fatigue. The lack of interest from the consumer stakeholders in this initiative,
especially compared to the response rate from the chemical industry, was noticeable in other
stakeholder consultation activities as well. To boost the response rate of the online survey, the
study team sent reminders to consumer organisations to complete this survey, however, this
did not result in a significantly higher participation rate.
504
Annex 14 – Exemption from the scope of CLP for
certain products
CONTEXT
The 2019 Fitness Check on chemicals reports that, during consultation activities, some
Member States and NGOs pointed to potential gaps and inconsistencies regarding
identification and communication of hazards in some sectorial legislation such as cosmetic
products, medical devices, food and feed additives. For instance, these stakeholders
emphasised that in the case of Cosmetic Products Regulation (CPR), the focus on human
health protection could result in not considering environmental hazards and fate of cosmetic
ingredients. Additional discussions on this topic took also place at the REACH and CLP
competent authorities meeting in 2013130
.
Relevant SDG
SDG #6 Clean water and sanitation – Target 6.3 ‘By 2030, improve water quality by reducing
pollution, eliminating dumping and minimizing release of hazardous chemicals and materials,
halving the proportion of untreated wastewater and substantially increasing recycling and
safe reuse globally’;
SDG #12 Responsible consumption and production – Target 12.4 ‘By 2020, achieve the
environmentally sound management of chemicals and all wastes throughout their life cycle,
in accordance with agreed international frameworks, and significantly reduce their release to
air, water and soil in order to minimize their adverse impacts on human health and the
environment’.
Societal trends:
Consumers and professional users concerned about hazardous chemicals
Growing environmental awareness of society, move towards more sustainable products
PROBLEMS
The hazards of certain chemical substances and mixtures are not optimally communicated
The CLP Regulation provides that all substances and mixtures displaying hazardous
properties must be labelled and packaged according to their classification (see also Annex 12
on labelling); this aims to protect human health and the environment and to ensure free
movements of chemicals in the single market. Through the identification and communication
of the hazards of substances and mixtures, the CLP Regulation provides key information
thereby enabling professional users and consumers to adopt all necessary precautions during
its use, storage and disposal; in addition, this allows them to make informed decisions when
purchasing a product.
130
Document CA/40/2013, 13th Meeting of Competent Authorities for REACH and CLP (CARACAL), 26-28
November 2013
505
The CLP Regulation generally covers all chemicals supplied in the EU, including products
sold to consumers. It also addresses a full range of hazards to human health and to the
environment, as well as physical hazards (e.g. flammability, explosiveness). However, Article
1(5) of CLP exempts a number of substances and mixtures, in the finished state and intended
for the final user, from its scope. These scope exemptions concern human131
and veterinary132
medicinal products, medical devices133
, cosmetics products134
, and food and feeding stuffs135
.
Recital 11 of CLP further clarifies that these exemptions are based on the premise that the
exempted sectorial legislations lay down more specific rules on classification and labelling.
The exempted product categories have a paramount impact on human health because they
enter, or come into close contact with, the human body, e.g. by ingestion or application to
skin. Therefore, the sectorial legislation exempted by Article 1(5) of CLP is primarily
oriented at the protection of health, and uses different measures to assess and ensure the
safety for users (e.g. negative and positive lists of substances that can be used in products,
risk assessments and authorisation processes, pre-defined lists of products that can be placed
on the market, classifications of products according to their complexity and inherent risks to
human health, etc.). These legislations may also include the possibility to provide warnings or
instructions for safe use to the user through labelling or packaging inserts, but usually
information on the hazards of a product is not available to the customer.
While all exempted legislations require a safety assessment for human health, and
communication on necessary precautions is covered by the respective legislation,
environmental aspects are addressed only in some of those areas. The quality and quantity of
evidence about the negative environmental impacts of the chemical products exempted from
CLP varies substantially. However, the analysis136
shows that all exempted product
categories (except food and feed where there is no solid evidence) can cause a certain degree
of environmental damage. It is important to note here that in some cases adverse
environmental effects may be caused by illegal or inappropriate disposal practices (e.g.,
flushing or pouring pharmaceuticals down the drain), while in other cases it is just the
consequence of their use (excretion of medicines).
There is solid quantitative evidence that human and veterinary medicinal products can
negatively affect the environment due to their hazardous properties137
, use and overuse but
also users’ inappropriate disposal practices (e.g., flushing unused or expired medicines
directly to household sewers).
Medical devices is a diverse product category with an estimated 5,000 to 24,000 different
types of products (most of which are articles and thus not subject to CLP provisions). There
is currently not enough evidence to identify the full spectrum of environmental issues that
may be caused by their use, storage and disposal for the whole group of medical devices.
131
as defined in Directive 2001/83/EC
132
as defined in Directive 2001/82/EC
133
as defined in Directives 90/385/EEC and 93/42/EEC, which are invasive or used in direct physical contact
with the human body, and in Directive 98/79/EC
134
as defined in Directive 76/768/EEC
135
as defined in Regulation (EC) No 178/2002 including when they are used (i) as a food additive in foodstuffs
within the scope of Directive 89/107/EEC; (ii) as a flavouring in foodstuffs within the scope of Directive
88/388/EEC and Decision 1999/217/EC; (iii) as an additive in feeding stuffs within the scope of Regulation
(EC) No 1831/2003; (iv) in animal nutrition within the scope of Directive 82/471/EEC.
136
Annex 7 of RPA report
137
Zhou et al. (2019). Environment international, 128, 1-10; O’Flynn et al. (2021). Analytical Methods, 13(5),
575-594; Barbosa et al. (2016). Water Research, 94, 257-279.
506
However, human health and environmentally hazardous substances can be used in some
medical devices when their use is justified and the benefits clearly outweigh the risks.138
While there are examples of hazardous substances being used in medical devices (e.g.
octylphenol ethoxylate), no comprehensive evidence has been found on the environmental
hazards and effects of in-vitro diagnostics and other medical devices composed of substances
and mixtures.
A number of extensive literature reviews139
highlight that cosmetics that contain ingredients
hazardous to the environment may have a substantial impact on the environment. Release into
the environment occurs in particular from rinse-off products that enter the wastewater system
and sunscreen products that are directly released into surface waters. Some cosmetic
products, such as personal care products containing plastic microbeads, siloxanes, synthetic
fragrances, and UV filters or triclosan, have negative effects on the environment due to their
hazardous properties and their releases to the environment during use.
Searching the ECHA registered substances database for substances with notified uses in
Product Category (PC) 28 ‘Perfumes, fragrances’ and PC39 ‘Cosmetics, personal care
products’ returns 3,248 substances. Around 8% of the substances have CLH for different
hazard classes. Fifty-six (56) substances have CLH for acute aquatic toxicity and 111 for
chronic aquatic toxicity. When self-classifications are included, ca 35% of substances with
notified uses in the above product categories have self-classifications for environmental
hazards, based on REACH registration data.
An ongoing study140
which assesses the feasibility of an extended producer responsibility
(EPR) scheme for micropollutants141
in the context of the revision of the Urban Waste Water
Treatment Directive (UWWTD) identified pharmaceuticals and personal care products
(PCPs) as the main sources of micropollutants reaching urban waste water treatment plants,
albeit the contribution from PCPs was lower than from pharmaceuticals. It was estimated that
PCPs constitute 26% of the total PNEC toxicity load (pharmaceuticals 66%).
There is solid evidence of adverse environmental effects arising from food waste, which, in
turn, originates from improper use, storage and disposal of food products. However, the
problem of food waste is not related to the environmental hazardous properties of food, but
rather the volume of food waste. Scientific peer-reviewed papers discuss the environmental
hazards of some food antioxidants (e.g., synthetic phenolic antioxidants142
). In 2015,
butylated hydroxytoluene (BHT) was included in the first Watch List for potential pollutants
of surface and ground waters in the EU143
.
138
EC, (2019). Why are potential dangerous phthalates allowed in medical devices, and who decides if their use
is warranted? Available at:
https://ec.europa.eu/health/sites/default/files/scientific_committees/docs/citizens_phthalates_en.pdf
139
Vita et al. (2018). Toxicology letters, 287, 70-82; Bom et al. (2019). Journal of Cleaner Production, 225, 270-
290; Juliano and Magrini (2017). Cosmetics, 4, 11-29; Brausch and Rand (2010). Chemosphere, 82, 1518-1532
140
Bioinnovation Service, 2022. Feasibility of an EPR system for micro-pollutants. Study for DG ENV, Unit C2
(under publication, exact ref to be added)
141
Micropollutants are substances found in water bodies or waste water with some toxic activity to humans or
ecosystems; some of them are toxic even in small concentrations (e.g. endocrine disruptors) and there is concern
about their chronic effect and about so-called cocktail effects when combining diffuse exposition to multiple
pollutants.
142
Wang et al. (2021). Environmental Research, 111531.
143
Negrão De Carvalho, R. et al. (2015). Publications Office of the European Union; 2015. JRC95018.
507
Problem drivers: Exemption of human and veterinary medicines, medical devices, cosmetics
and food and feed from the scope of CLP
The CLP Regulation provides information about the environmental hazards of substances and
mixtures to their recipients, i.e., professional users and consumers. The sectorial legislation
covers environmental aspects to a varying degree, but generally does not provide hazard
information to the users as it is required by the CLP Regulation on environmental endpoints.
The products which are exempted from CLP are equally exempted from the provisions in
REACH concerning information in the supply chain (Title IV), which i.e. provides that
professional users can request a safety data sheet, which could provide information on
hazardous properties of a mixture.
Human and veterinary medicinal products
The effects of human medicinal products (HMPs) and veterinary medicinal products
(VMPs) on the environment are addressed in the environmental risk assessment which
must be submitted as part of the marketing authorisation dossier. In cases where the
environmental risk assessments identifies a potential risk to the environment that
cannot be avoided, the applicant has to propose a risk mitigation strategy, including
information about the environmental risks of the medicinal product, appropriate use,
storage and disposal indicated on the label or in the package leaflet.144
However, the
environmental hazards of HMPs and VMPs are not communicated as such as it is
required for other chemical products in the scope of the CLP Regulation.
The review of evaluation studies, as well as scientific and technical reports, did not
find any conclusive evidence that more extensive labelling of medicines (based on
CLP environmental hazards) would substantially contribute to the mitigation of the
environmental hazards of pharmaceuticals. Furthermore, the systematic literature
reviews did not identify a clear link between environmental awareness and positive
change in consumer behaviour145
and indicated that more factors – e.g., availability of
medicine take-back programme, advice by doctors and pharmacists etc. shape the
behaviour of consumers with regard to the proper disposal of medicines146
.
Medical devices
The relevant legislation on Medical Devices and In Vitro Medical Devices147
does not
explicitly focus on environmental hazards; however, some safety requirements
addressing the safety of disposal of and emissions from medical devices (incl. in vitro
medical devices) might be relevant to the protection of the environment. Professional
users and consumers do not have access to information about environmental hazards
of medical devices, although some information on the environmental hazards is
provided for in vitro medical devices containing substances or mixtures which may be
considered dangerous. The labels and instructions for use of medical devices
144
EMA (2018). Guideline on the environmental risk assessment of medicinal products for human use.
Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-environmental-risk-
assessment-medicinal-products-human-use-revision-1_en.pdf
145
Kusturica et al. (2016). Reviews of Environmental Contamination and Toxicology, 240, 71-104.
146
Makki et al. (2019). Pharmacy, 7(2), 61.
147
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical
devices, OJ L 117, 5.5.2017, p. 1–175; Regulation (EU) 2017/746 of the European Parliament and of the
Council of 5 April 2017 on in vitro diagnostic medical devices, OJ L 117, 5.5.2017, p. 176–332
508
communicate relevant information on safe use, storage, handling and disposal of the
devices, where necessary.
Cosmetic products
The Cosmetic Products Regulation (CPR)148
does not contain any specific
requirements related to the identification, and assessment of the environmental
hazards of cosmetic ingredients or products, nor on the communication related to such
hazards. As stated in Recital (5) of CPR, the environmental concerns for cosmetics
products are to be addressed by REACH. While the Annexes of CPR prescribes
labelling for certain ingredients, including specific instructions for use, these are
limited to the human health related aspects under the scope of this legislation.
According to REACH, manufacturers and downstream users are obliged to assess
identified uses, including in cosmetic products, in a chemical safety report. Moreover,
REACH can place restrictions on certain uses of substances, including on cosmetic
ingredients. However, only a limited number of relevant cosmetic ingredients have
yet been addressed through restrictions under REACH (e.g.
Octamethylyclotetrasiloxane (D4) and Decamethylcyclopentasiloxane (D5),
microplastics (under development)).
Studies about environmental concerns and cosmetics purchasing behaviour show
multiple interacting factors that shape consumer behaviour. In the systematic review
of 80 research papers published in 2011-2017, One publication149
showed different
types of motivational factors and their interplay in purchasing decisions of green
personal care products and colour cosmetics. According to the study, in buying green
personal care products, health concerns are the main deciding factor that also
influences other motivational factors, such as internal (environmental attitudes,
values, environmental consciousness and attitude towards environmental
consumption), social (social pressure, family, friends’ attitudes etc.) and external
(environmental awareness, price, supply, etc.). Differently, when buying colour and
styling cosmetics, which is considered a luxury product, brand and quality play a
dominant role and influence other motivational factors.
Food and feed stuffs
In food legislation, the Regulation on genetically modified food and feed150
requires
the identification of environmental hazards is a part of the environmental risk
assessment. Other food legislation does not directly cover environmental risk
assessment, although some legal acts specify that environmental factors may be
considered, if relevant, in the approval of authorisation applications or as a part of
scientific risk assessments. All analysed animal feed legal acts provide an explicit
requirement for animal feed and animal feed additives to be safe for the environment.
The analysis of the effects on the environment must be provided in authorisation
applications. The review of the food and feed legislation did not find any specific
labelling requirements addressing the environmental hazards covered by CLP.
148
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on
cosmetic products, OJ L 342, 22.12.2009, p. 59–209
149
Liobikienė, G. and Bernatonienė, J. (2017). Journal of Cleaner Production, 162, 109-120.
150
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on
genetically modified food and feed, OJ L 268, 18.10.2003, p. 1–23.
509
How likely is the problem to persist?
Human and veterinary medicinal products
Pharmaceutical consumption is growing worldwide. In the EU, due to an aging population,
the consumption of drugs to treat ageing-related and chronic diseases is expected to remain
significant, although a reduction in the consumption of all pharmaceuticals has been observed
since 2015. Due to the inappropriate management, treatment, and disposal, discharges of
pharmaceuticals and their metabolites into the environment are expected to increase151
. The
European Commission has a number of ongoing initiatives to address environmental
pollution from medicinal products. The Strategic approach to pharmaceuticals in the
environment and the Farm to Fork Strategy aim to mitigate the environmental issues caused
by both human and veterinary medicines. To tackle the presence of pharmaceuticals and their
negative effects on the environment, in 2019 the European Commission has adopted the
Strategic approach to pharmaceuticals in the environment, which aims to mitigate the
environmental issues caused by human and veterinary medicines. The strategy provides many
measures for improving the environmental risk assessment of medicinal products and raising
public awareness about proper use and disposal.
Cosmetics
The global market for cosmetics has grown at an average rate of 4% in the period 2011-
2019.152
The European market is expected to follow the global trends, both in terms of
growth of the different business segments (skincare, haircare, makeup, fragrances and
hygiene products) and channels (strong growth of online sales).
There are ongoing regulatory initiatives that can have an impact on mitigating the
environmental risks of chemicals including cosmetic products:
Currently, the CPR is being reviewed to align the current rules on cosmetics with the
objectives of the Chemicals Strategy for Sustainability.
The Sustainable Product Initiative (SPI), a legislative framework, announced in 2020 in the
Circular Economy Action Plan, targets the environmental performance of goods and services.
By revising the Ecodesign Directive, high environmental performance will be ensured for all
products (i.e. covering cosmetic products as well) on the EU market. For this purpose,
specific environmental requirements and sustainability principles will be developed. SPI will
address the current lack of reliable sustainability information about the products. By offering
relevant solutions, such as e.g., digital tagging, digital product passports, it will improve
communication of the environmental performance of the product to consumers and enable
them to make informed decisions when buying a product. The revision is planned to be
completed in the first quarter of 2022.
The Introduction of new hazard classes in CLP (intervention area 1), in conjunction with the
revision of REACH in 2022 which i.e. aims at extending the use of the Generic approach to
risk management
151
González Peña et al. (2021). Int. J. Environ. Res. Public Health 2021, 18, 2532.
152
L’Oreal, Cosmetics Market 2020. https://www.loreal-finance.com/en/annual-report-2020/cosmetics-market-
2-1-0/
510
The ongoing revision of UWWTD included a feasibility study of establishing an Extended
producer responsibility (EPR) scheme for products responsible for introducing contaminants
of emerging concern into waste water. Following the polluter-pays principle, this would
ensure that those who place the concerned products on the EU market (producers, importers,
retailers, etc.) are responsible for the complete lifecycle of the products, including reduction
of discharges into the environment. Such a scheme could improve product composition so
that their environmental impacts at the end of life is eliminated or reduced, and/or finance
additional costs for removing pollutants from waste water by additional cleaning steps.
There is a growing interest in the environmental performance of products in general and
providing consumer with transparent information in particular. In 2021, the European
Commission revised the EU Ecolabel criteria for cosmetics. The revised criteria for awarding
the EU Ecolabel now apply both to rinse-off and leave-on cosmetic products and include i.a.
toxicity to aquatic organisms and biodegradability of rinse-off products and leave-on
products, specific exclusions and restrictions of hazardous ingredients, packaging and
sustainable sourcing of certain oils. Growing interest in getting the EU Ecolabel has been
recently observed. According to the European Commission, 2,057 licences have been
awarded for 83,590 products in the EU. Of those, the share of 21% (118) of licenses were
awarded to rinse-off cosmetic products with 3% (2,575) of products in this group granted the
EU Ecolabel (EC, 2021g).
Cosmetics Europe argues in its environmental sustainability report153
that many members of
the association have been systematically reporting their environmental performance on their
websites and provides some examples of environmental performance assessment in some
cosmetics companies. Finally, in 2021, a global consortium of cosmetic manufacturers
launched an initiative to develop an environmental impact assessment and scoring system for
cosmetics products. The assessment and scoring systems will be based on a common product
lifecycle assessment methodology for measuring the environmental impacts of a product,
common database of environmental impacts and tools to calculate them in line with a
harmonized system for scoring the environmental performance.154
This initiative is under
preparation and in a recent press release155
(23 February 2022) the consortium announced that
“A footprinting and scoring prototype is targeted for end of 2022, providing the
environmental scoring for a selection of product categories at first.”
Stakeholders’ views
According to the findings of two recent Eurobarometer surveys, the European citizens are
highly concerned about the environmental issues and would like to be informed about them.
A recent survey on the attitudes of Europeans towards the environment has shown that most
Europeans (94%) think that protecting the environment is important to them personally, while
over half (53%) believe that it is very important. Moreover, 90% of Europeans are worried
about the impact of chemicals present in everyday products on the environment156
. The
Eurobarometer survey on chemical safety demonstrated that slightly less than half Europeans
feel well-informed about chemicals contained in products such as paints, detergents,
153
Cosmetics Europe, 2019
154
Unilever, 2021
155
ecobeautyscore-consortium--pr--english-version.pdf (loreal.com)
156
Kantar (2020). Special Eurobarometer 501: attitudes of European citizens towards the environment.
Available at: https://europa.eu/eurobarometer/surveys/detail/2257
511
cosmetics, etc. Yet, the main sources about potential dangers of chemicals in products are
product labels (for 70% of respondents) and the media (for 53%)157
.
A recent behavioural experiment158
assessed the objective understandability of labels by
Europeans from selected countries. It concluded that when the label information was
available the majority of participants were able to identify less harmful products much better
than in cases when there was no label information. Similarly, when the label information was
available the experiment participants performed much better in correctly identifying the
hazards of a product than when no label information was presented.
A large group of OPC respondents, including citizens, public authorities and civil societies
felt that the provision of information on the environmental hazards of veterinary medicines,
medical devices, cosmetics, and food or feed, was ‘an issue which should be immediately
solved’ (see also synopsis report in Annex 2). Differently from other respondents, business
entities and associations felt that there is an issue to be immediately solved only for human
medicines, while for other exempted products there is no issue at all. Opinions on the
regulatory gaps in addressing the environmental hazards borne by the products exempted
from the CLP Regulation gathered through the TSS vary. Business entities and associations
are of the view that the environmental hazards of the exempted products are properly covered
by sectorial legislation. Public authorities believed that the environmental hazards are
insufficiently addressed by the sectorial legislation regulating human and medicinal products,
as well as medical devices, but they considered that the sectorial legislation adequately
addresses the environmental hazards of cosmetics, food and feed products. It should be noted
that a very low number of public authorities and NGOs participated in the TSS to confidently
draw conclusions about predominant view within these groups.
The analysis of the position papers in the OPC has shown a very low number of position
papers dedicated to the issue of CLP scope exemptions. The findings from the analysis of
open questions in TSS demonstrated conflicting opinions on the problem in this intervention
area. While some respondents believed that the sectorial legislation regulating the exempted
products is fit for purpose, others indicated that the exempted products are not properly
regulated under sectorial legal acts. However, in the latter case, no substantial argument was
provided on the gaps in the sectorial legislation. Many interviewees commented that the
measures to address the potential environmental hazards of the exempted products are in
place, although they are risk-based rather than hazard-based.
POTENTIAL POLICY MEASURES
The problem that consumers (as well as professional users of certain products) do not receive
optimal information on the hazards of certain chemical substances could be addressed by
amending Article 1(5)(a) of CLP to revoke the exemption for the labelling for the hazards of
these products. Sub-options of this measure would be to selectively revoke the exemption for
a certain product area i.e. human medicinal products, veterinary medicinal products, medical
devices, cosmetic products or food and feeding stuff.
157
TNS opinion & social (2017). Special Eurobarometer 456: chemical safety. Available at:
https://europa.eu/eurobarometer/surveys/detail/2111
158
VVA Economics & Policy, ConPolicy, Ecorys (2021). Impact assessment study on the simplification of the
labelling requirements for chemicals and the use of the e-labelling. Available at: in press.
512
SCREENING AND ASSESSMENT OF THE POTENTIAL MEASURES
The option to extend the human health labelling to chemicals that are currently excluded from
the scope of CLP was discarded as the analysed legislation contains comprehensive
provisions to assess hazards and risks to human health and to provide relevant information
and instructions to users. Therefore, additional labelling for human health hazards according
to CLP would not contribute to an increased level of protection
The option of amending Article 1(5)(a) of CLP to revoke the exemption for the labelling of
the environmental hazards of all or individual exempted product categories was discarded and
not further pursued in the impact assessment on the following grounds:
Human and veterinary medicinal products
There is abundant evidence on the presence of pharmaceuticals in the environment, and for
their negative effects. The relevant legislation already contains provisions for environmental
risk assessment, risk mitigation and provision of information and instructions to users. To
mitigate the environmental issues caused by both human and veterinary medicines, the
Commission adopted the Strategic approach to pharmaceuticals in the environment159
in
2019, which includes numerous measures for improving the environmental risk assessment of
medicinal products and for raising public awareness about proper use and disposal. The
analysis done (see Appendix to this Annex) did not reveal any solid evidence that hazard
labelling according to CLP would substantially contribute to the mitigation of the
environmental hazards of pharmaceuticals. The current provisions on environmental hazard
assessment and communication to consumers in the relevant legislation, as well as already
ongoing initiatives, sufficiently address the problem and that the extension of additional
classification and labelling measures under CLP is unlikely to provide a significant added
value.
Medical devices
While environmental hazardous substances are used in some medical devices, there is no
solid evidence for a significant environmental impact from the diverse group of medical
devices (most of which are not substances and mixtures). The relevant legislation addresses,
to a certain degree, environmental effects and the provision of information to users.
Therefore, labelling for environmental hazards according to CLP is not expected to have a
significant added value.
Cosmetic products
A number of regulatory initiatives, including the revision of the CPR itself, as well as
revision of other legislations that may have an influence on the environmental hazard of
cosmetic products (Sustainable Product Initiative, Revision of the Urban Waste Water
Treatment Directive), make it difficult to conclude at this point in time on the possible
impacts and the appropriateness of revoking the exemption from CLP for cosmetic products.
There is solid evidence for negative environmental impacts from certain ingredients. The
relevant legislation does not provide for assessment of or information on environmental
159
Communication from the Commission to the European Parliament, the Council and the European Economic
and Social Committee. European Union Strategic Approach to Pharmaceuticals in the Environment. Available
at: https://ec.europa.eu/environment/water/waterdangersub/pdf/strategic_approach_pharmaceuticals_env.PDF
513
aspects. While environmental risks posed by cosmetic ingredients can be addressed by the
horizontal provisions of REACH, there is a regulatory gap in relation to information on
environmental hazards to users, which may be closed by removing the exemption in CLP for
cosmetic products. However, the impact of CLP labelling on consumer behaviour (use,
purchasing choices) is uncertain. Furthermore, a number of relevant initiatives are currently
under way, including the revision of the CPR itself, revision of other legislations that may
have an influence on the environmental hazard of cosmetic products (Sustainable Product
Initiative, Revision of the Urban Waste Water Treatment Directive), as well as actions of the
concerned industry to assess the environmental impact of products. These initiatives may
significantly change the availability of information on environmental impacts, as well as the
impact itself, of cosmetic products. Therefore, it is currently difficult to assess the likely
effect of labelling for environmental hazards according to CLP, and not possible to conclude
whether removing the exemption for cosmetic products in CLP is a suitable option.
Food and feeding stuff
There is no solid evidence for a negative environmental impact of such products.
Furthermore, the relevant legislation addresses, to a certain degree, environmental effects and
the provision of information to users. Therefore, labelling for environmental hazards
according to CLP is not expected to have a significant added value for most of these
products. However, regarding feed additives, the current revision of Feed Additive
Regulation addresses the environmental safety of feed additives as well as labelling issues
(EC, 2020e).
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Appendix – Exemption from the scope of CLP for
certain products: Legislative Analysis and
Literature Review160
INTRODUCTION
The objective of this evidence collection exercise is to support the review of the scope of
exemptions from the CLP Regulation. According to Article 1(5) of the CLP Regulation, it
covers all chemicals placed on the market except for those excluded from its scope.
Veterinary and human medicinal products and medical devices fall out of the scope of the
CLP Regulation, as well as cosmetics products, feed and food (senso largo). As provided by
Recital 11 of CLP, this exemption is based on the assumption that sectorial legislation
provides for specific classification and labelling rules (“This Regulation should, as a general
principle, apply to all substances and mixtures supplied in the Community, except where
other Community legislation lays down more specific rules on classification and labelling
…"). However, the hazards borne by those excluded products, especially environmental
hazards, may not be covered to the extent provided by the CLP Regulation. Moreover, it may
not be clear how the exclusion provisions must be applied in all cases, because some
definitions diverge between the CLP Regulation and specific products legislation (in
particular the wording of ‘in the finish state’ and ‘intended for the final user’) and for other
reasons.
In consultation activities carried out for the supporting study to the Fitness Check of
chemicals legislation (RPA et al., 2017), Member State authorities and NGOs have identified
gaps and inconsistencies in identification and communication of health and environmental
hazards caused by cosmetic products, food and feeding additives and medical devices.
However, the Fitness Check of chemicals legislation did not cover all exempted areas. Only
the CPR and the Medical Devices Directives were extensively covered by the analysis. Few
other legal acts concerning human and veterinary medicines and food additives were briefly
considered without a thorough examination.
The following research questions are investigated:
RQ1: Does the sectorial legislation that regulates the exempted products provide the same
level of protection from the environmental hazards borne by these products as the CLP
Regulation?
RQ2: Do the definitions in the CLP Regulation and sectorial legislation covering the
exempted products (particularly those related to ‘in the finished state’ and ‘intended for the
final user’) provide sufficient clarity to decide whether the CLP exemptions apply to a
product?
For several reasons, this study does not cover health hazards borne by the products that are
exempted from the CLP Regulation. All exempted products have a paramount impact on
human health because of close contact with and use by humans. Therefore, the sectorial
160
Performed in the context of the Service contract “Technical and Scientific Support to the Commission’s
Impact Assessment for the revision of the Regulation on Classification, Labelling and Packaging of substances
and mixtures” (group led by RPA Europe). See Annex 1
515
legislation covered by Article 1(5) of the CLP Regulation is specifically oriented at the
protection of health and uses a lot of different measures for this purpose comparable to
classification and labelling – e.g., negative and positive lists of substances that could be used
in products, extensive risk assessments and rigorous authorisation processes, the pre-defined
lists of products that could be placed on the European market, extensive classifications of
products in according to the complexity and inherent risks to human health, etc. So far,
previous review and evaluation activities of chemical legislation do not provide any solid
quantitative evidence of gaps in protecting human health from the hazards borne by the
exempted products.
For the reasons outline above, this analysis is focused on the classification and labelling
requirements related to the environmental hazards borne by the products exempted from the
CLP Regulation.
Article 1(5) of the CLP Regulation states:
This Regulation shall not apply to substances and mixtures in the following forms, which are
in the finished state, intended for the final user:
(a) medicinal products as defined in Directive 2001/83/EC;
(b) veterinary medicinal products as defined in Directive 2001/82/EC;
(c) cosmetic products as defined in Directive 76/768/EEC;
(d) medical devices as defined in Directives 90/385/EEC and 93/42/EEC, which are
invasive or used in direct physical contact with the human body, and in Directive
98/79/EC;
(e) food or feeding stuffs as defined in Regulation (EC) No 178/2002 including when
they are used:
(i) as a food additive in foodstuffs within the scope of Directive 89/107/EEC;
(ii) as a flavouring in foodstuffs within the scope ofDirective 88/388/EEC and
Decision 1999/217/EC;
(iii) as an additive in feeding stuffs within the scope of Regulation (EC) No
1831/2003;
(iv) in animal nutrition within the scope of Directive 82/471/EEC.
To answer the research questions two methodological approaches – analysis of legislation
and rapid literature review of the evidence available in the scientific peer-reviewed and grey
literature sources – are applied.
METHODOLOGY
To answer the research questions outlined in the introduction specific methodological
approaches were developed. Each research question was detailed into relevant sub-questions,
tasks necessary to collect relevant evidence, methods to collect the evidence and data sources.
Figure 95 shows the structural scheme of the suggested research methodology.
516
Figure 95: Structural scheme of research methodology
RQ1 was divided into two sub-questions, investigating:
the differences/commonalities in provisions related to identification and communication of
hazards of the exempted products in the sectorial legislation and the CLP Regulation
(RQ1.1);
whether the differences identified in answering RQ1.1 could cause gaps in the protection
from the environmental hazards borne by the exempted products (RQ1.2).
To answer RQ1.1, the sectorial legislation regulating the exempted products was analysed.
For each product type, the legislative framework has been identified by consulting the
thematic websites of the European Commission. Regulations, Directives and guidelines were
screened for general safety requirements, product market authorisation and environmental
risk assessment procedures, including labelling requirements. Twenty-two relevant legal acts
were identified and analysed (see Table 158).
Table 159: Legal acts regulating the exempted products
Product Legal acts
517
Table 159: Legal acts regulating the exempted products
Human
and
veterinary
medicinal
products
Regulation 726/2004 laying down Community procedures for the authorisation and supervision
of medicinal products for human and veterinary use and establishing a European Medicines
Agency (Regulation on Authorisation and Supervision of Medicinal Products)
Medicinal Products Directive 2001/83/EC
Veterinary Medicinal Products Regulation 2019/6 (will come into force on 28 January 2022)
Cosmetics Cosmetics Regulation 1223/2009
Medical
devices
The Medical Devices Regulation 2017/745
In Vitro Medical Devices Regulation 2017/746
Food and
feed
General:
Regulation 178/2002 laying down the general principles and requirements of food law,
establishing the European Food Safety Authority and laying down procedures in matters of
food safety (Regulation on food law)
Regulation 1829/2003 on genetically modified food and feed (Regulation on GM food and
feed)
Regulation 1830/2003 of the European Parliament and of the Council of 22 September 2003
concerning the traceability and labelling of genetically modified organisms and the traceability
of food and feed products produced from genetically modified organisms (Regulation on
traceability and labelling of GMO in food and feed)
Food–specific obligations and procedures:
Regulation 1169/2011 on the provision of food information to consumers (Regulation on Food
Information to Consumers)
Regulation 2019/1381 on the transparency and sustainability of the EU risk assessment in the
food chain
Regulation 1331/2008 establishing a common authorisation procedure for food additives, food
enzymes and food flavourings (Regulation on a common authorisation procedure)
Specific food products:
Regulation 2015/2283 on novel foods
Regulation 2017/2468 laying down administrative and scientific requirements concerning
traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the
European Parliament and of the Council on novel foods (Traditional Foods Regulation)
Regulation 2017/2469 laying down administrative and scientific requirements for applications
referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the
Council on novel foods (Regulation 2017/2469 on requirements for novel foods applications)
Regulation 1333/2008 on food additives (Food Additives Regulation)
Regulation 1332/2008 on food enzymes and amending Council Directive 83/417/EEC, Council
Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and
Regulation (EC) No 258/97 (Food Enzymes Regulation)
Regulation 1334/2008 on flavourings and certain food ingredients with flavouring properties
for use in and on foods (Food Flavourings’ Regulation)
Feed:
Regulation 767/2009 on the placing on the market and use of feed (Feed Regulation)
Regulation 429/2008 on detailed rules for the implementation of Regulation (EC) No
1831/2003 of the European Parliament and of the Council as regards the preparation and the
presentation of applications and the assessment and the authorisation of feed additives
(Regulation on the Implementation rules)
Regulation 1831/2003 on additives for use in animal nutrition (Regulation on additives in
animal nutrition)
518
To answer RQ1.2, in the first place, the European Commission legislation evaluations and
checks as well as other studies conducted for and by other European institutions were
analysed. This analysis was necessary to understand if any regulatory gaps on hazard
identification and communication in the sectorial legislation (as detected through the
legislation analysis) could lead to issues in protection from the environmental hazards of the
exempted products. Furthermore, where relevant we identified the EU policy documents
supported by evidence and used them as a source for evidence collection (e.g., Strategic
Approach to Pharmaceuticals in the Environment, Farm to Fork Strategy, etc.). The analysis
of the relevant EU documents and studies was followed by the investigation of scientific
peer-reviewed and grey literature publications. For each exempted product, the analysis
followed four main steps, shown in Figure 96.
Figure 96: Main steps of analysis to answer RQ1.2
At each step, the quality of evidence was assessed to understand whether available evidence
is sound. For this purpose, the guidance provided by Better Regulation Tool #4 (EC, 2021c)
combined with the hierarchy of evidence suggested by Evans (2003) was used. The quality of
the evidence is understood as its strength in terms of the influence of the research design on
the generalizability and argumentation of research results. For instance, the results of
international cross-sectional quantitative survey could be representative of the European
Union if it covers relevant countries, while the findings of a national survey could not. The
following grading framework has been applied:
Excellent – large-scale studies that cover international datasets of substantial quantity and
diversity. E.g., systematic literature reviews, international cross-sectional quantitative surveys
(e.g., for studying attitudes, perceptions and behaviour).
Good – results obtained by direct observation or survey studies of a lesser scale, such as, e.g.,
national quantitative surveys.
Fair – studies that do not cover large audiences even at national level and/or does not provide
a reproducible quantitative methodology. These are for instance, narrative literature reviews
(i.e. without a systematic approach to collection and selection of evidence), qualitative
research (focus groups, interviews).
519
Poor – expert opinions expressed in expert working groups, dedicated events or through
stakeholder surveys, case studies with a qualitative methodology.
N/A – legal acts, guidelines and policy documents were not assessed for the quality/strength
of evidence.
Evidence assessment matrix for all evidence sources used in this study is provided in
Appendix 1 to Annex 4.
To answer RQ2, it was divided into two sub-questions (detailed motivation is provided in the
analysis section):
RQ2.1: what issues are faced by the duty holders as a result of the absence of definitions of
‘in the finished state’ and ‘intended for the final user’ in Article 1(5) of the CLP Regulation?
RQ2.2: Whether legislation on the products exempted from the CLP Regulation provides any
concepts related to ‘in the finished state’ and ‘intended for the final user’ that could facilitate
decisions on the application of the CLP exemption provisions?
To answer RQ2.1, annual reports on the activities of national helpdesks published by ECHA
in 2018, 2019 and 2020 were analysed to understand what the most frequent and relevant
questions to the helpdesks are. Furthermore, questions related to the definitions in ECHA’s
Q&A section were investigated.
To collect evidence on RQ2.2, an analysis of definitions in the sectorial legislation regulating
the exempted products was conducted. The quality of available evidence was evaluated based
on the recommendations of Better Regulation Tool #4 (EC, 2021c).
The main limitation of the evidence analysis is that it does not give an exhaustive evidence
review on each product exempted from the CLP Regulation. Due to the broadness of topics
addressed (i.e. human and veterinary medicinal products, cosmetics, medical devices, food
and feed), a thorough systematic literature review on each exempted product is not possible
within the scope of this supporting study. Therefore, this evidence collection exercise aimed
to identify the main trends and evidence sources related to each product. The evidence
search was focused on several types of sources:
systematic literature reviews,
narrative literature reviews, where systematic ones were not available,
EU-wide quantitative surveys, and
national surveys or case studies if the sources covering EU were not available.
This approach was adopted from the hierarchy of evidence by Evans (2003); in his model,
systematic literature reviews are the best sources of evidence in terms of effectiveness,
appropriateness, and feasibility. Systematic literature reviews provide a transparent and
reproducible methodology for including publications under analysis and assessing their
quality. They cover substantial periods and number of publications (usually, from 5-10 years
and several dozens to hundreds of publications) to reflect the main trends in scientific
knowledge and gaps. Similarly, international surveys provide stronger evidence than national
surveys and case studies.
520
MEDICINAL AND VETERINARY MEDICINAL PRODUCTS
Legislative framework
Three legal acts focused on veterinary medicinal products (VMP) and medicinal products for
human use (HMP) were identified (see Table 159). A market authorisation is needed for
placing these types of products on the market. Common market authorisation procedures for
veterinary medicinal products and medicinal products for human use are laid out in
Regulation 726/2004 on Authorisation and Supervision of Medicinal Products. Specific
requirements for each type of medicinal product are provided in Medicinal Products Directive
2001/83/EC and Veterinary Medicinal Products Directive 2001/82/EC. Regulation 2019/6
lays down rules for the placing on the market, manufacturing, import, export, supply,
distribution, pharmacovigilance, control and use of veterinary medicinal products. This
repeals Directive 2001/82/EC and amends the provisions of Regulation (EU)
726/2004 relating to the authorisation and supervision of veterinary medicines, which
currently governs the centralised marketing authorisation procedure for both human and
veterinary medicines. Regulation 2019/6 will apply since 28 January 2022; therefore, the
Directive 2001/82/EC was not included in the analysis.
Table 160: Overview of medicinal and veterinary medicinal products legislation
Type of products Legislation
Medicinal and
medicinal veterinary
products
Regulation 726/2004 laying down Community procedures for the authorisation and
supervision of medicinal products for human and veterinary use and establishing a
European Medicines Agency (Regulation on Authorisation and Supervision of
Medicinal Products)
Medicinal products for
human use
Medicinal Products Directive 2001/83/EC
Veterinary medicinal
products
Veterinary Medicinal Products Regulation 2019/6 (will come into force on 28
January 2022)
Legal acts’ search identified several specific regulations on medicinal products, namely,
Regulation 141/2000 on medicinal products for rare diseases, Regulation on medicinal
products for children 1901/2006 and Regulation on advanced therapy medicinal products
1394/2007. These regulations complemented the requirements set in Regulation 726/2004,
Directive 2001/83/EC and did not contain any additional provisions focused on the
identification, classification and communication of the environmental hazards, so these are
not covered in this mapping exercise.
Identification and classification of environmental hazards
In medicinal and veterinary medicinal products legislation, environmental hazards of
products are identified in the environmental risk assessment (ERA), which is carried out as a
part of activities in preparing a dossier for marketing authorisation. Marketing authorisation
can be granted through various procedures, such as centralised, mutual recognition,
decentralised or national procedure. However, an ERA is required for all new marketing
authorisation applications for a medicinal product through all these procedures (EMA, 2018).
The common procedure for marketing authorisation of medicinal (HMPs – human medicinal
products) and veterinary medicinal products (VMPs) is laid out in Regulation 726/2004,
while Medicinal Products Directive 2001/83/EC and Veterinary Medicinal Products’
Regulation 2019/6 provide specific requirements. For both HMP and VMP, an
environmental risk assessment is therefore required for placing a product on the market.
521
Applicants who intend to place either HMP or VMP on the market are obliged to submit an
environmental risk assessment as a part of the authorisation dossier. Table 160 summarises
provisions regarding the environmental risk assessment found in the legal acts.
Table 161: Provisions regarding identification and classification of environmental hazards in medical
devices
Legislation Provisions
Regulation
726/2004 on
Authorisation
and
Supervision of
Medicinal
Products
Article 6(2) states that in the case of a medicinal product for human use containing or
consisting of genetically modified organisms within the meaning of Article 2 of Directive
2001/18/EC, the application shall be accompanied by:
(a) a copy of the competent authorities' written consent to the deliberate release into
the environment of the genetically modified organisms for research and
development purposes where provided for in Part B of Directive 2001/18/EC or in
Part B of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release
into the environment of genetically modified organisms (1);
(b) the complete technical dossier supplying the information required by Annexes III
and IV to Directive 2001/18/EC;
(c) the environmental risk assessment in accordance with the principles set out in
Annex II to Directive 2001/18/EC; and
(d) the results of any investigations performed for the purposes of research or
development.
Article 31(2) specifies that in the case of a veterinary medicinal product containing or
consisting of genetically modified organisms within the meaning of Article 2 of Directive
2001/18/EC, the application shall also be accompanied by:
a copy of the written consent of the competent authorities to the deliberate release into the
environment of the genetically modified organisms for research and development purposes,
as provided for in Part B of Directive 2001/18/EC or in Part B of Directive 90/220/EEC;
the complete technical file supplying the information required under Annexes III and IV to
Directive 2001/18/EC;
the environmental risk assessment in accordance with the principles set out in Annex II to
Directive 2001/18/EC; and
the results of any investigations performed for the purposes of research or development.
Medicinal
Products
Directive
2001/83/EC
Under Article 6(1), no medicinal product may be placed on the market of a Member State
unless a marketing authorisation has been issued by the competent authorities of that
Member State in accordance with this Directive or an authorisation has been granted in
accordance with Regulation (EC) No 726/2004, read in conjunction with Regulation (EC)
No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on
medicinal products for paediatric use ( 2 ) and Regulation (EC) No 1394/2007.
According to Article 8(3), the application for a marketing authorisation of a medicinal
product must be accompanied by:
(ca) evaluation of the potential environmental risks posed by the medicinal product.
This impact shall be assessed and, on a case-by-case basis, specific arrangements to limit it
shall be envisaged.
(g) reasons for any precautionary and safety measures to be taken for the storage of the
522
Table 161: Provisions regarding identification and classification of environmental hazards in medical
devices
Legislation Provisions
medicinal product, its administration to patients and for the disposal of waste products,
together with an indication of potential risks presented by the medicinal product for
the environment.
(iaa) The risk management plan describing the risk management system which the
applicant will introduce for the medicinal product concerned, together with a summary
thereof.
Annex I, Part I, Module I, 1.6 specifies that where applicable, applications for marketing
authorisations shall include a risk assessment overview evaluating possible risks to the
environment due to the use and/or disposal of the medicinal product and make
proposals for appropriate labelling provisions. The environmental risk connected with
the release of medicinal products containing or consisting of GMOs (Genetically Modified
Organisms) within the meaning of Article 2 of Directive 2001/18/EC of the European
Parliament and of the Council of 12 March 2001 on the deliberate release into the
environment of modified organisms and repealing Council Directive 90/220/EEC ( 1 ) shall
be addressed.
Veterinary
Medicinal
Products
Regulation
2019/6
Article 5(1) states that a veterinary medicinal product shall be placed on the market only
when a competent authority or the Commission, as applicable, has granted a marketing
authorisation for that product in accordance with Article 44, 47, 49, 52, 53 or 54.
Article 8(1) specifies the requirements to the content of a marketing authorisation. It refers
to Annex I of the Regulation for the documentation requirements. Article 8(2) defines
additional requirements for antimicrobial medicinal products as follows:
(a) documentation on the direct or indirect risks to public or animal health or to the
environment of use of the antimicrobial veterinary medicinal product in animals;
(b) information about risk mitigation measures to limit antimicrobial resistance
development related to the use of the veterinary medicinal product.
Annex I sets the requirements for the particulars and documents accompanying an
application for marketing authorisation.
Title I of Annex I, Requirements for veterinary medicinal products other than
immunological veterinary medicinal products, Part 3: Safety and residues tests, Section 6:
Environmental risk assessment describes the procedure of the environmental risk
assessment for products containing/not containing genetically modified organisms. Sub-
section 6.1 states that an environmental risk assessment shall be performed to assess the
potential harmful effects, which the use of the veterinary medicinal product may cause to
the environment and to identify the risk of such effects. The assessment shall also identify
any precautionary measures which may be necessary to reduce such risk. Sub-section 6.2
outlines that in the case of a veterinary medicinal product containing or consisting of
genetically modified organisms the application shall also be accompanied by the documents
required under Article 2 and Part C of Directive 2001/18/EC.
Title II of Annex I, Requirements for immunological veterinary medicinal products, Part D.
Environmental risk assessment, Part 3: Safety tests, Section D. Environmental risk
assessment describes the procedure of the environmental risk assessment. It states that
the purpose of the environmental risk assessment is to assess the potential harmful
effects, which the use of the product may cause to the environment and to identify any
precautionary measures, which may be necessary to reduce such risks.
523
The requirements and process of the environmental risk assessment of medicinal products for
human use are described in the guidelines by the European Medical Agency (EMA, 2018).
According to EMA (2018) ‘It is mandatory for the dossier for the marketing authorisation of
HMP to include an ERA. This ERA is based on the use of the product and the
physicochemical, ecotoxicological, and fate properties of its active substance’. The ERA
should be updated if there is an anticipated increase in environmental exposure. It is
important to stress that the ERA focuses on the properties of the active substance. EMA
(2018) clarifies that ‘excipients do not generally require an ERA unless there is a specific
toxicological effect to suggest an environmental risk under the product’s conditions of use.’
All medicinal products, in principle, require an ERA and a PBT assessment. An ERA may
also consist of a justification for not submitting ERA studies. The ERA consists of two
phases: in Phase I, ‘the potential for environmental exposure is assessed based on the nature
of the active substance and the intended use’ and ‘products that require a more extensive
Phase II risk assessment – either standard or tailored - are identified’.
ERA Phase I results in a predicted environmental concentration in surface water (PECSW)
value. If the value is above 0.01 μg/L, the medicinal product active substance needs to
undergo ERA Phase II. Phase II requires the determination of the physicochemical properties,
fate and ecotoxicity. These need to be determined by applying GLP tests following OECD
test guidelines. A number of methods are based on methods described in REACH and the
Water Framework Directive Environmental Quality Standards. Phase II results in the
calculation of predicted no-effect concentration (PNEC) values for different environmental
compartments and risk quotients (RQ = PEC / PNEC). If RQ is equal to or above 1, the risk
to the environmental compartment cannot be excluded and therefore the applicant should
propose adequate precautionary and safety measures to protect soil ecosystems.
The PBT assessment follows the criteria for the identification of PBT and vPvB substances
specified in Annex XIII of the REACH Regulation.
Finally, for active substances with a specific mode of action (e.g. antibiotics and endocrine
active substances), EMA (2018) requires tailored assessments.
ERA results in assigning a medicinal product to one of the following categories that lead to
specific labelling requirements:
No significant risk to the environment or Current ERA data does not suggest a
potential risk to the environment.
ERA has identified a potential risk to the environment.
In cases, when ERA identified a potential risk to the environment and it cannot be avoided,
the applicant should propose a risk mitigation strategy, including information about the
environmental risks of the medicinal product, appropriate use, storage and disposal indicated
on the label or in the package leaflet. Provision of such information on the label or in the
packaging leaflet considered on case-by-case basis depending on the specific risk (EMA,
2018).
ERA of the veterinary medicinal products (VMPs) is a two-phase process that is detailed in
the guidelines describing the requirements and content of each phase (EMA, 2000). Similarly
to HMPs, ERA considers only the use of the VMP and physicochemical, ecotoxicological
524
and fate properties of its active substance. The results of ERA trigger specific risk mitigation
measures and appropriate labelling to inform users and professionals.
Phase I is focused on the assessment of the environmental exposure of a VMP and determines
if an ecotoxicological assessment is necessary. Phase I assessment considers active substance
and other constituents (excipients) of a VMP, its methods of administration, target species
and proposed pattern of use. This assessment is mandatory for all VMPs. The decision if
Phase II assessment is necessary is taken based on the predicted environmental concentration
of a VMP in soil for the terrestrial compartment and environmental introduction
concentration for the aquatic compartment and intended use and intrinsic properties of a
VMP. For VMPs with predicted environmental concentrations below 100 µg/kg or
environmental introduction concentration 1 µg/L, Phase II assessment is not required.
However, because of concerns related to the intrinsic properties of a VMP and their effects on
the environment, a tailored risk assessment might be needed.
Phase II covers a three-tiered ecotoxicological assessment, which is based on risk quotient
(RQ), which is a ratio between predicted environmental concentration and predicted no-effect
concentration in terrestrial and aquatic compartments. If RQ is lower than 1, no further
testing is needed, while if the RQ is equal or above one, assessment moves to tier B to
generate more data on the environmental compartments where RQ is higher than one. If the
tier-B assessment concludes that a VMP poses a risk to the environment, tier-C assessment
based on more realistic scenarios is required. Physicochemical properties, environmental fate
and environmental effects studies should be performed following the OECD guidelines and
by applying Good Laboratory Practice. If Phase II assessment concludes that a VMP poses an
unacceptable risk to the environment, the applicant should propose measures to reduce the
risk to an acceptable level.
The guidelines for specific aspects of assessing veterinary medicinal products are under
development. In the recent concept paper, the European Medicines Agency acknowledged
that ‘while the available guidance documents (see above for details) provide detailed
information on how to estimate the environmental exposure of VMPs intended for use in
terrestrial animals, they do not provide comprehensive guidance on how to perform an ERA
for VMPs intended for use in aquaculture facilities’ (EMA, 2021a).
Labelling and communication of the environmental hazards of the products to
downstream users
In all legal acts ‘labelling’ is treated broadly as any information provided on the outer or
immediate packaging of the products (see Table 161). HMPs and VMPs are also
accompanied by a package leaflet that may also contain important information about the
safety of the products, their disposal or any precautionary measures to be taken.
Table 162: Labelling and related definitions
Legislation Definitions
Regulation
726/2004 on
Authorisation
and Supervision
of Medicinal
Products
Article 2 specifies that the definitions laid down in Article 1 of Directive 2001/83/EC and
those laid down in Article 1 of Directive 2001/82/EC shall apply for the purposes of this
Regulation.
Veterinary
Medicinal
Products
Article 4 provides the following definitions:
(24) ‘labelling’ means information on the immediate packaging or the outer packaging;
(25) ‘immediate packaging’ means the container or any other form of packaging that is in
525
Regulation
2019/6
direct contact with the veterinary medicinal product;
(26) ‘outer packaging’ means packaging in which the immediate packaging is placed;
(27) ‘package leaflet’ means a documentation leaflet on a veterinary medicinal product
which contains information to ensure its safe and efficacious use;
Medicinal Products Directive 2001/83/EC indicates that the label must contain specific
precautions relating to the disposal of unused medicinal products or waste derived from them.
However, such requirement is absent in the newer Veterinary Medicinal Products Regulation
2019/6.
Table 163: Provisions on the communication of product hazards to the environment to users*
Legislation Provisions
Regulation
726/2004 on
Authorisation
and Supervision
of Medicinal
Products
No specific requirements related to the environmental hazards are mentioned.
Medicinal
Products
Directive
2001/83/EC
Article 54 specifies the content of the medicinal product label. Among other required
content it must contain:
(g) a special warning, if this is necessary for the medicinal product;
(i) special storage precautions, if any;
(j) Specific precautions relating to the disposal of unused medicinal products or
waste derived from medicinal products, where appropriate, as well as reference to any
appropriate collection system in place.
Annex I, Part I, Module I, 1.6 specifies the content requirements of the risk assessment
and indicates that applications for marketing authorisations shall include a risk assessment
overview evaluating possible risks to the environment due to the use and/or disposal
of the medicinal product and make proposals for appropriate labelling provisions.
Article 62 states that the outer packaging and the package leaflet may include symbols or
pictograms designed to clarify certain information mentioned in Articles 54 and 59(1) and
other information compatible with the summary of the product characteristics which is
useful for the patient, to the exclusion of any element of a promotional nature.
According to Article 63(1), the particulars for labelling listed in Articles 54, 59 and 62
shall appear in an official language or official languages of the Member State where the
medicinal product is placed on the market, as specified, for the purposes of this Directive,
by that Member State.
Veterinary
Medicinal
Products
Regulation
2019/6
Recital (52): In order to reduce administrative burden and maximise the availability of
veterinary medicinal products in the Member States, simplified rules should be laid
down as to how their packaging and labelling are to be presented. The textual
information provided should be reduced and, if possible, pictograms and abbreviations
could be developed and used as an alternative to such textual information. Pictograms and
abbreviations should be standardised across the Union. Care should be taken so that
those rules do not jeopardise public or animal health or environmental safety.
Article 10(1) specifies the requirements for information on the immediate packaging of
veterinary medicinal products. Among other required information it must contain (g)
special storage precautions, if any.
Article 14(1) sets the requirements for information provided in the package leaflet of a
veterinary medicinal product. Among other required information it must contain (i)
526
Table 163: Provisions on the communication of product hazards to the environment to users*
Legislation Provisions
information essential for safety or health protection, including any special precautions
relating to use and any other warnings.
NOTE: *User may include professional users and consumers
Table 162 shows that some legal acts put requirements to provide information related to
storage precautions, special warnings and disposal of the product. However, other
environmental hazards identified through risk assessment may not be necessarily displayed.
According to the VMP Regulation, information on the label and leaflet as well as special
precautions for the protection of the environment and other product features are provided in
the summary of product characteristics (Article 33(1), Article 35(1)). Summaries of product
characteristics are provided in the Union VMP database which is accessible to the general
public (Article 55(1) and (2); Article 56(3)).
Evidence on the gaps in protection from the environmental hazards
Firstly, evaluation, impact assessment and technical and scientific studies that related to HMP
and/or VMP legislation were identified and screened to find evidence of potential gaps in
protection from the environmental hazards borne by human and/or veterinary medicinal
products.
The research presented in the studies recognised that inappropriate use and disposal of
medicinal products and gaps in the environmental risk assessment are among the reasons
why medicines occur in the environment. The pharmaceuticals used by humans and animals
are excreted with the urine, veterinary medicinal products occur in the environment with
animal feed surplus, while human medicines are often disposed of through household sewers
or trash bins. The rates of human medicines’ consumptions are high. For instance, in 2008,
the consumption of active pharmaceutical ingredients in the EU varied from 50 to 150 g of
API per capita annually (with average world consumption of 15 g of API per capita). High
quantities of veterinary medicinal products were also reported in the EU farms
(BioIntelligence Service, 2013; Deloitte, INERIS, Mileu, LSE, 2016). Trends in sales of
veterinary antimicrobial agents have been systematically reported by the European Medicines
Agency (EMA). According to the recent report, 5577.8 tonnes of antimicrobial veterinary
medicines were sold in 31 European countries in 2020 with the largest amounts of penicillins
(with proportion of 31.1% of total amounts sold in mg per population correction unit),
tetracyclines (26.7%) and sulfonamides (9.9%). However, a substantial decrease (43.2%) in
sales, especially in high selling countries was observed between 2011 and 2020 (EMA,
2021c).
The evidence for pharmaceuticals in the environment was collected through extensive
literature reviews in scientific and technical reports (BioIntelligence Service, 2013; Deloitte,
INERIS, Mileu, LSE, 2016; European Commission, 2014). The recent report also focused on
the feasibility aspects of the environmental risk assessment of pharmaceuticals (Schwonbeck
et al., 2021).
The effects on the environment vary by individual pharmaceuticals, among documented
impacts are decreasing vulture population due to poisoning with diclofenac, impaired
reproduction of fish due to contraceptive Ethinylestradiol, and many others (BioIntelligence
527
Service, 2013). Based on the growing scientific evidence on the presence of pharmaceuticals
in the environments, some of them have been monitored as potential pollutants in surface
and groundwaters under the Watch List of priority substances in the field of water policy
(European Parliament and Council, 2013) that aims to determine the risks of these substances
to the aquatic environment across the EU. The Watch List has been periodically updated. The
first Watch List was published in 2015 and contained one synthetic and two natural
hormones, a pain killer diclofenac, and three macrolide antibiotics (EC, 2015b). The Watch
List was revised in 2018 and covered two new antibiotics – amoxicillin and ciprofloxacin,
while the pain killer diclofenac was removed (EC, 2018d). In 2020, the Watch List was
updated for the third time and included several new pharmaceuticals – antibiotics
(sulfamethoxazole and trimethoprim), antidepressant venlafaxine and its metabolite O-
desmethylvenlafaxine, and three azole pharmaceuticals (clotrimazole, fluconazole and
miconazole) (EC, 2020f). Substances for the watch list have been selected based on various
criteria, including scientific evidence and expert consultations. Proposals of substances and
related evidence are documented in the reports by the Joint Research Centre (Gomez Cortes
et al., 2020; Loos et al., 2018; Negrão De Carvalho et al., 2015). The Watch List is an
important measure for identifying the emerging pollutants and gathering reliable data for
identifying their risk posed across the EU.
Scientific literature provides abundant evidence about the occurrence of both human
and veterinary pharmaceuticals in the environment and their adverse effects. The volume
of literature (including literature reviews) is very high; therefore, only some examples of
relevant systematic literature reviews are discussed here:
O’Flynn et al. (2021) examined over 100 scientific publications covering the 2009-2020
period, to understand the whole lifecycle and the concentrations of six pharmaceuticals
(azithromycin, ciprofloxacin, sulfamethoxazole, gemfibrozil, diclofenac, and venlafaxine) in
the EU surface waters. The researchers emphasised that azithromycin, ciprofloxacin and
sulfamethoxazole are of particular concern due to their ability to encourage the growth of
antimicrobial-resistant organisms in an environmental setting. Various factors, such as
obesity, population growth and an ageing population led to the increased usage of many
pharmaceuticals such as gemfibrozil, diclofenac and venlafaxine.
According to the systematic literature review of papers published in 1998-2016 that analysed
pharmaceuticals in the environment by Zhou et al. (2019), approximately 60% (284) of the
analysed substances were positively detected in one or more of 33 European countries. Forty-
five analysed compounds showed a potential environmental risk to aquatic ecosystems, 12 of
them were indicated to have high environmental risk in aquatic environments, while 17 and 7
compounds showed moderate and small-scale environmental risks.
In the systematic literature review, Barbosa et al. (2016) summarised the occurrence, adverse
effects on the environment and removal in aqueous matrices of 10 substances and group of
substances listed in the Second EU Watch List and discussed in the research papers published
in 2005-2015. Among the discussed substances – steroid hormones (EE2, E2 and E1),
diclofenac, and macrolide antibiotics.
In the systematic literature review of 1166 scientific publications, Tim aus der Beek et al.
(2015) analysed the global occurrence of human and veterinary pharmaceuticals. Residues of
16 human and/or veterinary pharmaceutical substances were detected in the surface, drinking,
and groundwater of all analysed regions. Diclofenac was the most widely available
pharmaceutical due to its frequent use for humans and animals. However, other
528
pharmaceuticals, such as carbamazepine (antiepileptic), sulfamethoxazole (antibiotic),
ibuprofen, and naproxen (both analgesics) were found almost as often as diclofenac.
With regard to veterinary medicinal products, the recent scientific review paper by the
European Medicines Agency found that the environmental risk assessment of 108 VMPs in
the EU conducted during the centralised authorisation procedure was terminated after Phase I
assessment in 95% of cases. Only one negative opinion for a VMP – LONGRANGE, was
issued due to a serious long-term risk for dung fauna that could not be mitigated to an
acceptable level. The authorisations veterinary medicines containing zinc oxide and
Pharmasin were withdrawn because of their environmental risks (Fabrega & Carapeto, 2020).
Considering the abundant evidence on the presence of pharmaceuticals and their negative
effects on the environment, the Strategic approach to pharmaceuticals in the environment
was adopted by the European Commission in 2019, which aims to mitigate the environmental
issues caused by both human and veterinary medicines (EC, 2019g). To implement the
Strategic approach to pharmaceuticals in the environment many measures for improving the
environmental risk assessment of medicinal products and raising public awareness about
proper use and disposal of them were foreseen. Table 163 provides examples of measures to
ensure protection from the environmental hazards borne by pharmaceuticals that have been
implemented within the Strategic approach to pharmaceuticals in the environment.
529
Table 164: Overview of measures related to the environmental risk assessment and public awareness of the
environmental hazards of pharmaceuticals, compiled from European Commission, 2020
Measure Status
Action 5.1.1 Promote the development of guidelines for healthcare professionals on the prudent
use of pharmaceuticals posing a risk to or via the environment.
Ongoing
Action 5.1.4 Foster best-practice exchanges between the Member States on how environmental
considerations are taken into account in the advertising and prescription of medicinal products
and the choice of therapy more generally, where appropriate.
Ongoing
Action 5.3.1a In collaboration with the European Medicines Agency and the Member States:
Seek to improve the level of environmental expertise in the Committees and networks involved
in the environmental risk assessment of medicinal products.
Ongoing
Action 5.3.1b In collaboration with the European Medicines Agency and the Member States:
Consider developing guidance on the environmental risk assessment of medicinal products for
use in aquaculture including, where appropriate, recommendations for risk management
measures.
Started
Action 5.3.1c In collaboration with the European Medicines Agency and the Member States:
Examine how to improve public access to the main environmental risk assessment results and
relevant toxicological thresholds for medicinal products while respecting data-protection rules.
Ongoing
Action 5.3.1d In collaboration with the European Medicines Agency and the Member States:
Emphasise to applicants the importance of submitting a completed assessment by the time of the
authorisation for marketing human medicinal products, so that adequate risk management
measures can be established and published.
Ongoing
Action 5.3.2 Pursuant to the newly adopted Regulation on veterinary medicinal products, report
on the feasibility of setting up an EU-wide review system based on active pharmaceutical
ingredients, or similar, to support the environmental risk assessment of veterinary medicinal
products at the Union level.
Started
Action 5.3.3 Initiate a systematic catching-up procedure for veterinary medicinal products
without an (adequate) environmental risk assessment, as provided for in the Regulation on
veterinary medicinal products, and take stock of the results of research under the Innovative
Medicines Initiative in relation to human medicinal products.
Ongoing
Action 5.4.1b In collaboration with the Member States and the European Medicines Agency:
Facilitate the exchange of best practices among healthcare professionals on the environmentally
safe disposal of medicinal products and clinical waste, and the collection of pharmaceutical
residues as appropriate.
Ongoing
Action 5.4.2 Assess the implementation of collection schemes for unused pharmaceuticals and
consider how their availability and functioning could be improved, how to increase public
awareness of the importance of using them, and how extended producer responsibility could
play a role in reducing inappropriate disposal.
Good
progress
According to the recent Inception Impact Assessment (EC, 2021e), the ongoing evaluation
and revision of pharmaceuticals’ legislation cover the improvements in the environmental
risk assessment.
Some of the identified reports focused on the measures to protect the environment from the
hazards borne by pharmaceuticals. For instance, the study supporting the Strategic approach
to pharmaceuticals in the environment proposed a revision of the CLP Regulation to remove
the exemptions on medicinal products (EC, 2019h). However, this option was mainly based
on the stakeholder consultation findings (Deloitte, 2017). It is important to note that only
20% of the respondents to public consultation believed that clear labelling of environmental
risks to allow informed choices of equivalent therapeutic options were most effective actions
to limit negative environmental impacts of medicines. Similarly, the expert workshop
organised in 2009 by the European Environment Agency came up with a proposal to classify
environmental hazards and improve the labelling of pharmaceuticals (EMA, 2010). Again,
this proposal was based on the expert opinion of the workshop participants. However, the
analysis of review, evaluation and revision studies, as well as scientific and technical
530
reports, did not reveal any solid quantitative evidence that more extensive labelling of
medicines will substantially contribute to the mitigation of the environmental hazards of
pharmaceuticals.
Controversial views on the environmental hazards of human and veterinary medicines were
collected in consultation activities. A large group of business entities and associations (53%,
94) felt that the provision of information on the environmental hazards of human medicines
was ‘an issue which should be immediately solved’ (see Annex 2 for OPC response analysis).
Similarly, in TSS consultation, business entities and associations were of the view that the
environmental hazards of the exempted products are properly covered by sectorial legislation.
However, the OPC findings showed that in the groups of citizens and civil societies different
opinions prevailed. Fifty-seven per cent (134) of citizens and 67% (42) of civil societies felt
that provision of information on the environmental hazards of human medicines is not an
issue. Differently, in case of veterinary medicines, 54% (127) of citizens and 65% (40) of
civil societies believed that the provision of information on the environmental hazards of
VMP requires an immediate solution. The group of respondents representing public
authorities was too small both in OPC and TSS to draw any conclusions. This was also the
case for citizens respondent group in TSS.161
Furthermore, to understand the links between classification and labelling of pharmaceuticals
mitigation of their environmental hazards, a search of scientific and grey literature was
performed by using Google Scholar and PubMed search engines for scientific publications.
This search focused on the studies of consumer behaviours regarding pharmaceuticals and
means to prevent medicines to occur in the environment.
Many studies focused on human pharmaceuticals are available; however, most focus on the
non-European countries where the legislative framework and consumer behaviour may
substantially differ from the European Union. Therefore, only fourteen studies related to the
EU in general and the specific Member States were included. Five of them were grey
literature reports published by the international (e.g., OECD) and national (e.g., German
Environment Agency, Finnish Environment Institute, etc.) bodies, while nine – scientific
peer-reviewed publications. Furthermore, reports and papers published earlier than 2010 were
not included as well, since consumer habits, as well as regulatory and non-regulatory
measures, evolve.
Surveys of consumers of HMP in various countries (Dias-Ferreira et al., 2016; Rogowska et
al., 2019; Vellinga et al., 2014; Zorpas et al., 2018; Finnish Environment Institute, 2020;
noPILLS, 2015) and systematic literature reviews of such studies (Kusturica et al., 2016;
Makki et al., 2019) revealed significant differences in storage and disposal of HMP by
consumers. High awareness and proper disposal of HMP was observed in Sweden, Finland,
Portugal, and France, while the behaviour of disposing of HMP through household sewage or
trash bins was more common in Poland, Latvia, Lithuania, Ireland and Cyprus. However, the
surveys were conducted in different periods, so cannot be compared. Different methodologies
were used, e.g., questionnaire surveys and interviews. Most national studies were not
representative of the whole country because they focused on particular regions (e.g., Vellinga
et al., 2014) or applied non-probability sampling (e.g., Rogowska et al., 2019; Zorpas et al.,
2018). The systematic literature reviews did not identify a clear link between
161
As for all other intervention areas, OPC and TSS results need to be interpreted with caution. Both
surveys did not apply a random sampling approach, and the number of respondents in each stakeholder group
varies substantially, meaning that the results are not representative for each group of stakeholders.
531
environmental awareness and positive change in consumer behaviour (Kusturica et al.,
2016) and indicated that more factors – e.g., availability of medicine take-back
programme, advice by doctors and pharmacists etc. shape the behaviour of consumers
with regard to proper/inappropriate disposal of medicines (Makki et al., 2019). In some
cases, environmental awareness did not preclude the inappropriate disposal of medicines
(Rogowska et al., 2019). Surveys of pharmacies in Romania (Bungau at al., 2018) revealed
that pharmacies may play a significant role – the findings showed that due to unclear
regulatory framework and responsibilities, pharmacies refused to collect unused medicines
from citizens. The findings of the survey of the European authorities whose work is related to
medical waste indicated that combined measures of raising awareness of the citizens would
be applied to reduce the streams of household pharmaceutical waste (Vollmer, 2010).
Several studies referred to the example of classification of environmental hazards of
pharmaceuticals introduced in Sweden and used for advising healthcare professionals on
prescribing the medicines (OECD, 2019; Büro für Technikfolgen-Abschätzung beim
Deutschen Bundestag, 2019; UBA, 2014). However, all these reports did not provide any
reliable evidence of the contribution of this approach to changing the behaviour of Swedish
consumers.
The literature search did not detect any studies on the disposal behaviours related to VMP in
the EU. The scarcely available studies focused on the USA and UK (e.g., Vatovec, 2021;
Lam et al., 2018; Higham et al., 2018). Therefore, no conclusions can be made for consumer
behaviour related to VMP.
To summarise, the current studies show that the issues underlying the occurrence of
pharmaceuticals in the environment to a large extent relate to their use. However, the proper
use and disposal of human medicinal products depend on multiple factors that include the
availability of collection systems for pharmaceuticals, literacy and motivation of consumers
to dispose of medicines in appropriate ways as well as active engagement and advice to
consumers from other actors – e.g., pharmacists, healthcare professionals. Current activities
to mitigate the challenges caused by pharmaceuticals in the environment cover a variety of
regulatory and non-regulatory measures to raise public awareness of the issue and influence
consumer behaviour as well as to improve the environmental risk assessment of VMP and
HMP. Therefore, it can be concluded that the current provisions on environmental
hazard assessment and communication to consumers are sufficiently addressed in the
current legislation and that there is no evidence that the extension of additional
classification and labelling measures under CLP Regulation would provide benefits.
COSMETIC PRODUCTS
Legislative framework
The Cosmetics Regulation 1223/2009 is the main legal act that establishes rules for cosmetic
products available on the EU market. The Regulation aims to ensure the functioning of the
internal market and a high level of protection of human health.
Identification and classification of environmental hazards
Before being placed on the market, a cosmetic product must undergo a safety assessment
based on potential human health effects (Article 10). Annex I of the Regulation sets the
requirements to the content of a safety assessment report. Several annexes of the Regulation
list substances that are authorized for specific uses or that are prohibited or restricted under
certain conditions:
532
Annex II lists substances that are prohibited in cosmetic products;
Annex III lists the substances that cosmetic products must not contain except subject
to specified restrictions;
Annex IV lists the substances allowed to be used as colourants;
Annex V lists the substances allowed to be used as preservatives; and
Annex VI –lists the substances allowed to be used as UV filters.
There are no specific requirements related to the identification and classification of the
environmental hazards in the Cosmetics Regulation. As stated in Recital (5) the
environmental concerns for cosmetics products are addressed by the REACH Regulation.
Table 165: Provisions regarding identification and classification of environmental hazards in medical
devices
Legislation Provisions
Cosmetics
Regulation
1223/2009
Recital (5): The environmental concerns that substances used in cosmetic products may
raise are considered through the application of Regulation (EC) No 1907/2006 of the
European Parliament and of the Council of 18 December 2006 concerning the Registration,
Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a
European Chemicals Agency, which enables the assessment of environmental safety in a
cross-sectoral manner.
The content and requirements to a cosmetic product safety report are specified in Annex 1 of
Regulation 1223/2009. The annex does not contain specific provisions for assessing the risk
of cosmetic products to the environment.
Labelling and communication of the environmental hazards of the products to
downstream users
In compliance with Recital 5, the Cosmetics Regulation 1223/2009 does not define specific
provisions for classification and labelling for environmental hazards; otherwise, there are
substantive labelling requirements for cosmetic products in the Regulation. The analysis of
the legal requirements did not identify specific provisions on the communication of the
environmental hazards to cosmetics users. In addition to information placed on the label,
Recital (53) and Article 21 outlines conditions when the users can access relevant
information about cosmetic products. However, it does not consider specific information
about environmental hazards.
533
Table 166: Provisions on the communication of environmental hazards of cosmetic products to users*
Legislation Provisions
Cosmetics
Regulation
1223/2009
Annex V Preamble Point 2: All finished products containing formaldehyde or substances in
this Annex and which release formaldehyde must be labelled with the warning ‘contains
formaldehyde’ where the concentration of formaldehyde in the finished product exceeds
0.05 %.
Recital (53): In addition to the labelled information, consumers should be given the
possibility to request certain product-related information from the responsible person in
order to make informed product choices.
Pursuant to Article 21, without prejudice to the protection, in particular, of commercial
secrecy and of intellectual property rights, the responsible person shall ensure that the
qualitative and quantitative composition of the cosmetic product and, in the case of perfume
and aromatic compositions, the name and code number of the composition and the identity
of the supplier, as well as existing data on undesirable effects and serious undesirable
effects resulting from use of the cosmetic product are made easily accessible to the
public by any appropriate means.
The quantitative information regarding composition of the cosmetic product required
to be made publicly accessible shall be limited to hazardous substances in accordance
with Article 3 of Regulation (EC) No 1272/2008. (Article 21).
NOTE: *User may include professional users and consumers
Evidence on the gaps in protection from the environmental HAZARDS
Studies on evaluation, impact assessment as well as supporting studies that cover Cosmetics
Regulation were identified and screened to find evidence of potential gaps in protection from
the environmental hazards borne by cosmetics products. Only two studies address the
environmental hazards of cosmetic products. “Study on the regulatory fitness of the
legislative framework governing the risk management of chemicals (excluding REACH), in
particular, the CLP Regulation and related legislation” (RPA, European Commission, 2017)
provides the opinion of some public authorities in the Member States and NGOs on the lack
of classification and labelling requirements for environmental hazards under the Cosmetics
Regulation. “Study for the strategy for a non-toxic environment of the 7th Environment
Action Programme” (2017) discusses the environmental effects of chemicals used in
cosmetic products. The report reviewed the negative environmental effects of siloxanes that
are often used in cosmetic products. However, it should be noted that a proposal for
restriction of the following siloxanes – Octamethylcyclotetrasiloxane (D4)
Decamethylcyclopentasiloxane (D5) Dodecamethylcyclohexasiloxane (D6) (ECHA, 2019a)
based on the negative effects on the environment was adopted.162
Furthermore, studies supporting initiatives by the European Commission regarding protection
of the environment by raising customer awareness through labelling have been identified.
The first initiative was the EU Ecolabel, a voluntary environmental labelling scheme. The EU
Ecolabel is granted to the products for their environmental excellence, covering high
environmental performance of a product at different stages of its lifecycle (e.g.,
manufacturing, distribution, disposal, etc.). The EU Ecolabel Regulation sets the rules for
establishing and applying this scheme. In 2021, the Joint Research Centre carried out a
technical study to support the revision of EU Ecolabel criteria for rinse-off cosmetic products.
It outlined several criteria for granting Ecolabel based on the environmental performance of a
cosmetic product. For the purposes of formulating criteria, the CLP Regulation and REACH
162
https://echa.europa.eu/substances-restricted-under-reach
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were consulted. Based on the findings, the European Commission revised the EU Ecolabel
criteria for cosmetics and extended them to substances or mixtures that fall under the scope of
Cosmetics Regulation and “intended to be placed in contact with the external parts of the
human body, or with the teeth and the mucous membranes of the oral cavity, with a view
exclusively or mainly to cleaning them, perfuming them, changing their appearance,
protecting them, keeping them in good condition or correcting body odours” (EC, 2021g,
Article 1). The revised criteria for awarding the EU Ecolabel now apply both to rinse-off and
leave-on cosmetic products. They contain the following:
toxicity to aquatic organisms: critical dilution volume (CDV) of rinse-off products,
biodegradability of rinse-off products,
aquatic toxicity and biodegradability of leave-on products,
excluded and restricted substances,
packaging,
sustainable sourcing of palm oil, palm kernel oil and their derivatives,
fitness for use,
information on EU Ecolabel.
Growing interest in getting the EU Ecolabel has been recently observed. According to the
European Commission, 2,057 licences have been awarded for 83,590 products in the EU. Of
those, the share of 21% (118) of licenses were awarded to rinse-off cosmetic products with
3% (2,575) of products in this group granted the EU Ecolabel (EC, 2021g).
The further literature search identified abundant research on the environmental issues of
microplastics and especially plastic micro beads in cosmetic products as well as regulatory
initiatives to ban and/or reduce their use (Anagnosti et al., 2021). For instance, Eunomia
(2016) estimations that microplastics from cosmetic products contribute up to 4.1% or
between 2,461 and 8,627 tonnes of microplastics entering the marine environment from
Europe every year. However, according to the authors of the report, this estimate was very
uncertain due to the limited availability of data. The intentional use of microbeads in
cosmetic products was also discussed in the report “Intentionally added microplastics in
products” delivered at the request of the European Commission (Scudo et al., 2017). Based
on Eunomia (2016) research and other sources, the study estimated that 1250-1910 tonnes of
intentionally added plastic microbeads (5 mm or less) that are water insoluble plastic particles
are used in personal care products annually. However, this estimate is also uncertain due to
substantial gaps in data. The study usefully distinguished between rinse-off and leave-on
cosmetic products. Rinse-off products are washed off shortly after their application and enter
the environment via wastewater streams or by direct human uptake, while leave-on products
can also enter the environment via solid waste pathways (Scudo et al., 2017).
The issue of the environmental pollution by microplastics (including by plastic microbeads in
cosmetic products) was addressed in A European Strategy for Plastics in a Circular Economy
in 2018. Intentional use of plastic microbeads was also voluntarily reduced by the cosmetics
industry and microbeads were subject to national bans (EC, 2018g
). In January 2019,
ECHA proposed a wide-ranging restriction on microplastics in products placed on the
EU/EEA market to avoid or reduce their release to the environment. ECHA’s Committee for
Risk Assessment (RAC) adopted its opinion on the proposal in June 2020 with some
recommendations, while the Committee for Socio-economic Analysis (SEAC) – in December
2020. The European Commission decision is currently under preparation.163
According to the
163
https://echa.europa.eu/hot-topics/microplastics
535
estimations of the impact assessment study on intentionally added microplastics in products,
a restriction on the use of all synthetic polymers in personal care products could affect
approximately 18% of all EU personal care products (Scudo et al., 2017).
As the reports of the European Commission and other institutions lacked information on the
environmental issues of cosmetic products, scientific peer-reviewed and grey literature
searches were conducted to identify adverse effects of cosmetic products on the environment.
Several extensive literature reviews (Vita et al., 2018; Bom et al., 2019) highlight that
personal care - especially rinse-off - products that contain ingredients hazardous to the
environment may have a substantial impact on the environment because they could be
found in the household sewage shortly after their application. Some personal care products,
such as sunscreens, enter the aquatic compartment directly because of their use (e.g., use of
sunscreens during recreational activities) (Vita et al., 2018; Bom et al., 2019).
There is a growing interest of researchers in the environmental impacts of UV filters (Huang
et al., 2021) and their occurrence in water compartments (Cadena-Aizaga et al., 2020).
Currently, 45 UV filters are allowed in cosmetic products (ECHA, 2021e). Specific organic
UV filters in different concentrations were found on the seacoasts in Spain and the
Netherlands (Cadena-Aizaga et al., 2020), in the North and Baltic seas (Apel et al., 2018),
and French Mediterranean beaches (Labille et al., 2020). One of the widely used substances
in sunscreens, a sun blocking agent 2-Ethylhexyl 4-methoxycinnamate (EHMC), was
included in the EU Watch List of potential water pollutants (EC, 2015b). According to the
scientific evidence collected by the Joint Research Centre, EHMC was ubiquitous in the
European environment and was detected in surface water, sediment and biota (Negrão De
Carvalho et al., 2015). According to the JRC report, EHMC was included in the Draft
Community Rolling Action Plan (CoRAP) with several reasons of concern, such as
environment/suspected PBT, potential endocrine disruptor, wide dispersive use,
environmental exposure and high (aggregated) tonnage. In the systematic literature review,
Barbosa et al. (2016) noted that previous studies documented the presence of EHMC in the
lake and rivers sediments and concentrations in diverse organisms. According to Barbosa et
al. (2016), little is known about the removal of EHMC from aquatic environments.
The literature search identified four papers that experimented with the classification of the
ingredients of personal care products and sunscreens by applying the criteria of the CLP
Regulation (for details see Appendix 1 to Annex 4). The papers addressed the classification
of the environmental hazards of UV filters (Sobek et al., 2013) and personal care products
(Klaschka, 2012; Klaschka, 2015; Klaschka, 2016). All papers were case studies that applied
either classification and labelling criteria for investigating ingredients of cosmetic products or
used information on ingredients available in Classification and Labelling Inventory. The
studies stressed that some of the analysed ingredients were hazardous for the environment;
however, this information was not properly communicated to consumers of the cosmetic
products. Although all studies were based on empirical data collection, they were qualitative
small-scale case studies, so they do not provide enough evidence to cover different groups of
cosmetic products and ingredients.
To understand the role of hazard communication through labelling information, a search
was performed for relevant consumer research. Studies of the role of labelling information
about the environmental hazards of cosmetic products in their purchasing or use behaviour
are rare and mostly qualitative. For instance, Labille et al. (2020) conducted interviews of
471 visitors at three different Mediterranean beaches in France to analyse their habits of using
sunscreens, while Anderson et al. (2016) carried out four focus groups with 20 participants to
536
understand the perceptions considering microplastics in cosmetic products. However, the
studies provided quite different results. Labille et al. (2020) found that most of the
respondents (60±6%) were aware of the environmental effects of the sunscreens they used,
but there were no products labelled as eco-friendly among those they used. Although the
composition of the sunscreen was an important selection criterion for the respondents, 19% of
consumers cared about the composition of the product because of the possible effects on their
health, while only 3% of them expressed environmental concerns. Differently, Anderson et
al. (2016) found varying levels of awareness of the participants about the environmental
effects of plastic microbeads in cosmetic products and their readiness to change their
behaviour after getting information about the environmental hazards. However, as noted by
Anderson et al. (2016) the sense of urgency of the environmental issue also depended on
other factors: “Microbeads were seen as competing for attention with a number of other
environmental and societal issues and relatively low down the list of the public's priorities”.
More general studies about environmental concerns and cosmetics purchasing behaviour
show multiple interacting factors that shape consumer behaviour. For instance, in the
systematic review of 80 research papers published in 2011-2017, Liobikiene and
Bernatoniene (2017) showed different types of motivational factors and their interplay that
stimulate a decision to purchase green personal care products and colour cosmetics instead of
selecting non-green cosmetics. According to the study, in buying green personal care
products, health concerns are the main deciding factor that also influences other motivational
factors, such as internal (environmental attitudes, values, environmental consciousness and
attitude towards environmental consumption), social (social pressure, family, friends’
attitudes etc.) and external (environmental awareness, price, supply, etc.). Differently, when
buying colour and styling cosmetics, which is considered a luxury product, brand and quality
play a dominant role and influence other motivational factors.
When asked about possible gaps in information provision on the hazards of cosmetic
products (‘when buying or using the product categories listed below, you might not be
informed that they could be hazardous to the environment. What is your opinion?’), most
citizens (61%), public authorities (67%) and civil societies (69%) who participated in the
open public consultation considered that this issue should be immediately solved.
To summarise several conclusions can be made:
 The screened studies provided sufficient evidence that some cosmetic products have a
negative effect on the environment due to hazardous properties of their ingredients.
The environmental effect of some of them has been addressed by REACH
restrictions. Scientific peer-reviewed sources show that there are environmental issues
caused by specific cosmetic products, such as, e.g., sunscreens containing UV filters
and personal care products, that favour their release into household sewage or directly
into water compartments. REACH restrictions have been issued or are on the way on
the grounds of their harm to the environment for siloxanes and plastic microbeads that
have been used in cosmetics.
 The adverse effects of cosmetic product to the environment result from their use,
while appropriate measures of storage, safe use or disposal do not play a substantial
role in reducing their harm to the environment. Leave-on and rinse-off cosmetic
products follow similar ways to the environmental compartments through wastewater
and/or solid waste streams for leave-on cosmetics or may directly enter the
537
environment because of their use (e.g., in case of sunscreens). Often the only way to
avoid harm to the environment is to refuse using the product.
 Information about properties of the cosmetic products or its environmental
performance does not play a dominant role in consumer purchasing behaviour.
Although some qualitative studies highlight consumer opinions about the importance
of awareness about environmental effects of the cosmetic products, the studies of
consumer behaviour show that purchasing decisions are shaped by multiple factors.
There is a lack of evidence on how these factors interact and whether the informed
choice based on the awareness about the environmental hazards would result in
purchasing environmentally sustainable cosmetic products. It should also be noted
that current sources on green purchases emphasize that environmental awareness does
not play yet a dominant role.
The evidence search did not provide any additional data to change the conclusion made by
the Commission in the Staff working document on the evaluation of chemicals legislation:
“the focus of the Cosmetic Products Regulation solely on human health aspects was
identified as a legal gap by NGO stakeholders. While it may impact consumer ability to
differentiate between products in terms of their environmental performance (due to the lack
of labelling requirements on environmental hazards) and, therefore, to make better informed
purchases, in principle, any potential environmental risks arising from cosmetic ingredients
are addressed under REACH, for example, via authorisations or restrictions.” (European
Commission, 2019: p. 78-79).
MEDICAL DEVICES
Legislative framework
The term ‘medical device’ covers a wide range of products that could be instruments,
equipment, appliances, software, chemicals, etc. That are intended to be used for human
beings in order to fulfil certain medical purposes, such as diagnosis, prevention, monitoring,
treatment of disease or injury, alleviation or compensation for a disability, investigation or
modification of different physiological or pathological conditions or processes, in vitro
examinations of specimens derived from the human body (see Medical Devices Regulation
2017/745).
Different types of medical devices could be distinguished. Some medical devices are
composed of substances or combination of substances (i.e., mixtures). For classification
purposes, the Medical Devices’ Regulation (MDR) introduced the notion of “medical devices
composed of substances or combination of substances” (see MDR, Annex VIII, Chapter III.
Classification rules, Section 7. Special rules, rule 21). Based on it, medical devices as
substances and mixtures could be distinguished from medical devices that are articles.
Examples of medical devices composed of substances or mixtures include saline nasal drops
or sprays, dental fillings, disinfectants (e.g., iodine solution), syrups or throat sprays,
lubricants, artificial tear drops, bone cement, etc. Such medical devices are distinguished
from medicinal products based on their mode of action. Medical devices achieve the
intended result by physicochemical means (e.g., mechanical action, physical barrier, etc.),
while medicinal product reach the intended effect by pharmacological, immunological or
metabolic means (EC, 2015d; Racchi & Govoni, 2020). Furthermore, medical devices
composed of substances and mixtures should be distinguished from medical devices that are
articles, i.e. where the function of such device is determined by their shape, surface or design
538
rather than chemical composition. Examples of medical devices that are articles include
contact lenses, catheters, blood glucose meters and many others (Mereu & Lantres, 2022).
According to Article 1(5) of the CLP Regulation, only medical devices that are substances
and mixtures which are invasive or used in direct physical contact with the human body and
are in the finished form and intended for the final user are exempted from the CLP
Regulation.
The search for legislation identified two legal acts regulating medical devices in the EU:
The Medical Devices Regulation 2017/745 sets rules concerning the placing on the market,
making available on the market or putting into service medical devices for human use and
accessories for such devices in the Union. It also applies to clinical investigations concerning
such medical devices and accessories conducted in the Union. The Regulation came into
force on 26 May 2021, following a four-year transition period.
In Vitro Medical Devices Regulation 2017/746 lays down rules concerning the placing on the
market, making available on the market or putting into service of in vitro diagnostic medical
devices for human use and accessories for such devices in the Union. This Regulation also
applies to performance studies concerning such in vitro diagnostic medical devices and
accessories conducted in the Union. The Regulation 2017/746 will apply from 26 May 2022,
following a five-year transition period. Currently, manufacturers can opt to place in-vitro
diagnostic devices on the market under Directive 98/79/EC or under the new Regulation if
they fully comply with it (EMA, 2021b). In this mapping exercise, we will not consider the
Directive 98/79/EC.
Under Regulations 2017/745 and 2017/746, medical devices must undergo a conformity
assessment to demonstrate their safety and ability to perform as intended. Environmental
hazards are not explicitly considered by both legislations.
Identification and classification of environmental hazards
Under Regulations 2017/745 and 2017/746, medical devices must undergo a conformity
assessment to demonstrate their safety and ability to perform as intended. Some of the safety
requirements consider the safe disposal of these devices. The Regulation 2017/745 also
contains a provision on emissions from medical devices.
According to Article 51 of (MDR), all medical devices are classified considering their
intended purpose and inherent risks. The devices could be divided into classes I, IIa, IIb and
III in accordance with Annex VIII of the MDR. In addition, and according to Article 52(7)(a),
(b) and (c), Class I devices can be further subdivided into Is – sterile condition, Im –
measuring function and Ir – reusable surgical. Although all devices must comply with all
relevant obligations of the MDR; some requirements depend on the device classification
(MDCG, 2021).
Similarly, in accordance with Article 47 of In Vitro Medical Devices Regulation (IVDR),
devices are divided into classes A, B, C and D, based on the intended purpose of the devices
and their inherent risks. Specific procedures of conformity assessment depend on the
classification of a device (MDCG, 2020).
Safety assessment is an important part of the conformity assessment of the device in both
Regulations. As outlined in Annex I of Regulation 2017/745 on Medical Devices and in
539
Annex I of Regulation 2017/746 on In Vitro Medical Devices, safety relates to the safety of
patients, safety and health of users and where applicable other persons. It means that both
regulations are not explicitly focused on environmental concerns.
Table 167: Provisions regarding identification and classification of environmental hazards in medical
devices
Legislation Provisions
Regulation on
Medical
Devices
2017/745
Article 5 specifies the conditions that a medical device must satisfy to be placed on the
market. Following Article 5(2), a device shall meet the general safety and performance
requirements set out in Annex I which apply to it, taking into account its intended purpose.
In Annex 1 General Safety and Performance Requirements, Chapter I General
Requirements, environmental hazards/risks are not explicitly mentioned:
Paragraph 1: Devices shall achieve the performance intended by their manufacturer and
shall be designed and manufactured in such a way that, during normal conditions of use,
they are suitable for their intended purpose. They shall be safe and effective and shall not
compromise the clinical condition or the safety of patients, or the safety and health of users
or, where applicable, other persons, provided that any risks which may be associated with
their use constitute acceptable risks when weighed against the benefits to the patient and are
compatible with a high level of protection of health and safety, taking into account the
generally acknowledged state of the art.
However, some safety requirements specified in Annex 1 are relevant to the protection of
the environment. For instance, Annex 1, Chapter II Requirements to design and
manufacture:
Paragraph 10.4.1. indicates that devices shall be designed and manufactured in such a way
as to reduce as far as possible the risks posed by substances or particles, including wear
debris, degradation products and processing residues, that may be released from the
device.
Paragraph 14.7 specifies that devices shall be designed and manufactured in such a way as
to facilitate their safe disposal and the safe disposal of related waste substances by the
user, patient or other person. To that end, manufacturers shall identify and test procedures
and measures as a result of which their devices can be safely disposed of after use.
Regulation on
In vitro
Medical
Devices
2017/746
Article 5 specifies the conditions that an in vitro medical device must satisfy to be placed on
the market. Following Article 5(2), a device shall meet the general safety and performance
requirements set out in Annex I which apply to it, taking into account its intended purpose.
In Annex 1 General Safety and Performance Requirements, Chapter I General
Requirements, environmental hazards/risks are not explicitly mentioned:
Devices shall achieve the performance intended by their manufacturer and shall be designed
and manufactured in such a way that, during normal conditions of use, they are suitable for
their intended purpose. They shall be safe and effective and shall not compromise the
clinical condition or the safety of patients, or the safety and health of users or, where
applicable, other persons, provided that any risks which may be associated with their use
constitute acceptable risks when weighed against the benefits to the patient and are
compatible with a high level of protection of health and safety, taking into account the
generally acknowledged state of the art.
However, some safety requirements specified in Annex 1 are relevant to the protection of
the environment. For instance, Annex 1, Chapter II Requirements regarding performance,
design and manufacture, Paragraph 13.6 specifies that devices shall be designed and
manufactured in such a way as to facilitate their safe disposal and the safe disposal of
related waste substances by users, or other person. To that end, manufacturers shall
identify and test procedures and measures as a result of which their devices can be safely
540
Table 167: Provisions regarding identification and classification of environmental hazards in medical
devices
Legislation Provisions
disposed of after use.
However, under safety requirements in both regulations, manufacturers should ensure that
medical devices are manufactured in such a way that facilitates their safe disposal as well as
safe disposal of related substances by users or other persons. Furthermore, MDR Regulation
2017/745 indicates that devices shall be designed and manufactured in such a way as to
reduce as far as possible the risks posed by substances or particles, including wear debris,
degradation products and processing residues, that may be released from the device.
However, all safety requirements are targeted at the protection of the patients, users and other
persons involved in the use and disposal of the devices.
Compliance with the general safety requirements is supported with CEN-EN ISO 14971:2019
Medical devices — Application of risk management to medical devices. This standard aims to
assist manufacturers of medical devices to identify hazards related to a medical device, carry
out assessment, mitigate, and control the associated risks. ISO 14971:2019 applies to all
phases of life cycle of a medical device and covers both in vitro diagnostic medical devices
and medical devices. Risk management activities include identification of hazards and
hazardous situations associated with a medical device, risk assessment, risk control,
monitoring the effectiveness of the risk control measures. During the risk identification and
evaluation stages, hazards and hazardous situations are determined, and it is analysed to what
types of harm they may lead. In turn, ‘harm’ is defined as “injury or damage to the health of
people, or damage to property or the environment”. So, the environmental safety aspects are
considered; however, in Annex C that informs about hazards, hazardous situations and harm,
the focus on health aspects of harm prevails. The standard refers to the environment in a
sense of immediate surroundings or space where a medical device has been exploited – e.g.,
‘use environment’, ‘inappropriate environmental conditions’ (CEN, 2019).
Currently, in accordance with the Commission’s standardisation request M575, the standard
has been aligned with the medical device legislation; therefore, now CEN-EN ISO
14971:2019 does not apply to medical devices (EC, 2021h).
Labelling and communication of the environmental hazards of the products to
downstream users
Both regulations use the same definition for “label”, meaning the written, printed or graphic
information appearing either on the device itself or on the packaging of each unit or the
packaging of multiple devices (Regulation 2017/745, Article 2(13); Regulation 2017/746,
Article 2(13)).
Information communicated to users on the label mainly considers safe use, storage and
handling of the devices. Information of their safe disposal and related precautions are
provided in the instructions for use. According to the MDR, devices of class I and IIa may be
supplied without instructions for use if such devices can safely be used without the
instructions and no other provisions of Annex I Section 23 state otherwise (MDCG, 2021).
541
Table 168: Provisions on the communication of product hazards to the environment to users*
Legislation Provisions
Regulation on
Medical
Devices
2017/745
Devices shall be designed and manufactured in such a way as to facilitate their safe disposal
and the safe disposal of related waste substances by the user, patient or other person. To that
end, manufacturers shall identify and test procedures and measures as a result of which their
devices can be safely disposed of after use. Such procedures shall be described in the
instructions for use (Annex I, Chapter II, Paragraph 14.7).
According to Annex I, Chapter III, Section 23.1, the label must contain:
(k) an indication of any special storage and/or handling condition that applies;
(m) warnings or precautions to be taken that need to be brought to the immediate attention
of the user of the device, and to any other person. This information may be kept to a
minimum in which case more detailed information shall appear in the instructions for use,
taking into account the intended users;
Following Annex I, Chapter III, Section 23.4, this information should be provided in the
instructions for use:
(v) warnings or precautions to be taken in order to facilitate the safe disposal of the device,
its accessories and the consumables used with it if any. This information shall cover, where
appropriate:
— infection or microbial hazards such as explants, needles or surgical equipment
contaminated with potentially infectious substances of human origin, and
— physical hazards such as from sharps.
If in accordance with Section 23.1(d) no instructions for use are required, this information
shall be made available to the user upon request.
According to Article 32(1), for implantable devices and for class III devices, other than
custom-made or investigational devices, the manufacturer shall draw up a summary of
safety and clinical performance.
Pursuant to Article 32(2)(h), the summary of safety and clinical performance, must
include, among other requirements, information on any residual risks and any undesirable
effects, warnings and precautions.
Regulation on
In vitro
Medical
Devices
2017/746
According to Article 29(1), for class C and D devices, other than devices for performance
studies, the manufacturer shall draw up a summary of safety and performance. The
manufacturer shall mention on the label or instructions for use where the summary is
available.
Pursuant to Article 29(2)(h), the summary on safety and performance must include,
among other required elements, information on any residual risks and any undesirable
effects, warnings and precautions.
Following Annex I, Chapter II, Section 20.1(i), in the case of devices containing a
substance or a mixture which may be considered as being dangerous, taking account of
the nature and quantity of its constituents and the form under which they are present,
relevant hazard pictograms and labelling requirements of Regulation (EC) No
1272/2008 shall apply. Where there is insufficient space to put all the information on the
device itself or on its label, the relevant hazard pictograms shall be put on the label and the
other information required by Regulation (EC) No 1272/2008 shall be given in the
instructions for use.
Annex I, Chapter II, Section 20.2 lists information that must be provided on the label.
Among other requirements, it includes:
(k) an indication of any special storage and/or handling condition that applies;
(m) warnings or precautions to be taken that need to be brought to the immediate attention
of the user of the device or to any other person. This information may be kept to a minimum
542
Table 168: Provisions on the communication of product hazards to the environment to users*
Legislation Provisions
in which case more detailed information shall appear in the instructions for use, taking into
account the intended users;
In accordance with Chapter II, 13.6, devices shall be designed and manufactured in such a
way as to facilitate their safe disposal and the safe disposal of related waste substances by
users, or other person. To that end, manufacturers shall identify and test procedures and
measures as a result of which their devices can be safely disposed of after use. Such
procedures shall be described in the instructions for use.
Following the provisions of Annex I, Chapter III, Section 20.4.1, the following information
should be provided in the instructions for use:
(ac) warnings or precautions to be taken in order to facilitate the safe disposal of the
device, its accessories, and the consumables used with it, if any. This information shall
cover, where appropriate:
(i) infection or microbial hazards, such as consumables contaminated with potentially
infectious substances of human origin;
(ii) environmental hazards such as batteries or materials that emit potentially hazardous
levels of radiation;
(iii) physical hazards such as explosion.
NOTE: *User may include professional users and consumers
Warning or precautions related to the environmental hazards are required in the instruction
for use by the IVD Regulation 2017/746. For in vitro medical devices that contain substances
or mixtures that may be considered dangerous, Regulation 2017/746 already requires
applying hazard pictograms and labelling requirements of the CLP Regulation.
Storage and handling precautions and other information that requires the immediate attention
of the user of a medical device or any other person involved must be provided on the label.
Information and precautions related to the safe disposal of the device must be given in the
instructions for use.
Additional sources of information are so-called summaries of safety and clinical performance
of the device.
Evidence on the gaps in protection from the environmental hazards
The literature search identified only one study on the review of chemical legislation prepared
for the European Commission that mentioned the environmental hazards of medical devices
and potential gaps in legislation. The study drew attention to the gap in hazard
communication in the legislation on medical devices, where hazards are communicated
through safety data sheets that may not be understandable to the user. However, this finding
was based on the opinion of NGOs and Member States authorities in the stakeholder
consultation (RPA et al., 2017). Furthermore, the search did not detect any scientific and
technical reports or peer-reviewed scientific papers that discuss this issue. Therefore, an
overview of available literature that highlights environmental issues and their possible
reasons is provided.
543
The EU market for medical devices is worth €140 billion. The EU medical device industry is
composed of over 33,000 companies (of which 95% are SMEs) employing over 760,000
people. It is characterised by a high rate of innovation, ranking first among the sectors filing
patent applications, around 9% more than the computer and technology industries and 66%
more than the pharmaceutical industry.164
The medical devices’ industry is very diverse in
terms of complexity, purposes of use and features of the devices that may range from simple
products, such as syringes, catheters, face masks, to complex products, e.g. ultrasound and
CT scanners, anaesthesia machines equipment, etc. According to the WHO, there are between
5,000 to 24,000 types of medical devices under different classification and nomenclature
systems (WHO, 2021). MedTech Europe refers to over 500,000 medical technologies
available in hospitals, community care and household settings.165
Therefore, not all issues and
solutions apply to each type of medical device.
There is growing attention to the sustainability and environmental impact of medical devices
(Arun Kumar, 2021; Sousa et al., 2021; WHO, 2016; McGain & Naylor, 2014; Dalenstam et
al., 2012). However, the scientific literature search (+”medical devices” +environment)
revealed that the papers focus on medical devices that are articles, while the research
specifically addressing the environmental hazards or impact of medical devices
composed of substances or mixtures is not available. Lifecycle assessment studies have
been conducted to evaluate the environmental impacts of specific medical devices (Sousa et
al., 2021; Dalenstam et al., 2012). Environmental impacts and related costs have also been
investigated in case studies (see e.g., Piccoli et al., 2015).
Different sources emphasised that a large amount of solid waste is generated by medical
devices, in particular single-use devices (Sousa et al., 2021; WHO, 2016; McGain & Naylor,
2014). For instance, the WHO highlights that every year an estimated 16 billion injections are
administered worldwide, but not all of the needles and syringes are properly disposed of
afterwards (WHO, 2018).
According to WHO, about 85% of waste generated in healthcare activities is not hazardous
and can be recycled, while 15% constitutes infectious, chemical, or radioactive waste (WHO,
2018). Furthermore, reprocessing of specific single-use medical devices is allowed by Article
7 of the Medical Devices Regulation 2017/745. Complementing Regulation 2020/1207 on
reprocessing of single-use medical devices laid out common specifications for such activities.
When asked about possible gaps in information provision on the hazards of medical devices
(‘when buying or using the product categories listed below, you might not be informed that
they could be hazardous to the environment. What is your opinion?’), many citizens (55%),
public authorities (44%) and civil societies (67%) who participated in the open public
consultation considered that this issue should be immediately solved. However, qualitative
inquiries about medical devices in targeted stakeholder questionnaire and interviews did not
result in specific examples or references to the environmental hazards or effects of medical
devices on the environment.
To summarise the analysis of the available evidence, several conclusions can be made:
Available scientific and technical reports as well as peer-reviewed scientific papers
do not provide any information about the environmental hazards and,
164
Information provided by MedTech Europe.
165
https://www.medtecheurope.org/wp-content/uploads/2021/06/medtech-europe-facts-and-figures-2021.pdf
544
consequently, impacts of medical devices that are composed of substances or
mixtures. Most research focuses on medical devices that are articles. Therefore,
currently, it is not possible to provide any sound argument about the hazards of
medical devices that are substances or mixtures.
To get sound evidence on the environmental hazards and effects of medical devices
composed of substances and mixtures a targeted systematic literature search and
review is necessary based on the exhaustive lists of such medical devices and search
keywords derived from specific groups/names of specific devices that are substances
or mixtures.
Similarly, although medical devices enter the streams of healthcare waste, the study did not
identify any evidence about the share of medical devices that are substances/mixtures in
this type of waste and their impact to the environment. Furthermore, the review of the
available literature did not allow to identify estimates of the volumes and composition of
medical device waste and its environmental impacts in Europe.
FOOD AND FEEDING STUFFS
Legislative framework
Sixteen legal acts that cover the issues of identification and communication of the
environmental hazards in food and feed were identified through the analysis of the European
Commission websites and EUR-Lex database (see Table 168).
Table 169: Overview of food and feed legislation
Type of products Legislation
Food & feed
General
Regulation 178/2002 laying down the general principles and requirements of food
law, establishing the European Food Safety Authority and laying down procedures
in matters of food safety (Regulation on food law)
Regulation 1829/2003 on genetically modified food and feed (Regulation on GM
food and feed)
Regulation 1830/2003 of the European Parliament and of the Council of 22
September 2003 concerning the traceability and labelling of genetically modified
organisms and the traceability of food and feed products produced from genetically
modified organisms (Regulation on traceability and labelling of GMO in food and
feed)
Food
Focused on specific obligations and procedures
Regulation 1169/2011 on the provision of food information to consumers
(Regulation on Food Information to Consumers)
Regulation 2019/1381 on the transparency and sustainability of the EU risk
assessment in the food chain
Regulation 1331/2008 establishing a common authorisation procedure for food
additives, food enzymes and food flavourings (Regulation on a common
authorisation procedure)
Focused on specific food products
Regulation 2015/2283 on novel foods
Regulation 2017/2468 laying down administrative and scientific requirements
concerning traditional foods from third countries in accordance with Regulation
(EU) 2015/2283 of the European Parliament and of the Council on novel foods
(Traditional Foods Regulation)
Regulation 2017/2469 laying down administrative and scientific requirements for
applications referred to in Article 10 of Regulation (EU) 2015/2283 of the
European Parliament and of the Council on novel foods (Regulation 2017/2469 on
545
Table 169: Overview of food and feed legislation
Type of products Legislation
requirements for novel foods applications)
Regulation 1333/2008 on food additives (Food Additives Regulation)
Regulation 1332/2008 on food enzymes and amending Council Directive
83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC,
Council Directive 2001/112/EC and Regulation (EC) No 258/97 (Food Enzymes
Regulation)
Regulation 1334/2008 on flavourings and certain food ingredients with flavouring
properties for use in and on foods (Food Flavourings’ Regulation)
Feed
Regulation 767/2009 on the placing on the market and use of feed (Feed
Regulation)
Regulation 1831/2003 on additives for use in animal nutrition (Feed additives
Regulation)
Regulation 429/2008 on detailed rules for the implementation of Regulation (EC)
No 1831/2003 of the European Parliament and of the Council as regards the
preparation and the presentation of applications and the assessment and the
authorisation of feed additives (Regulation on the implementation rules)
Regulation 2019/4 on the manufacture, placing on the market and use of medicated
feed (Medicated feed Regulation)
Three legal acts give general provisions that are relevant to other food and feed
legislation. Regulation 178/2002 on food law is focused on common principles and
responsibilities, organisational arrangements and procedures in the field of food and feed
safety. Regulation 1829/2003 on GM food and feed sets out the procedures for authorisation
of and supervision of as well as labelling of genetically modified food and feed. Regulation
1830/2003 on traceability and labelling of GMOs in food and feed establishes a framework
for tracing the products that contain GMOs, and food and feed produced from GMOs to
facilitate labelling, monitoring the environmental and human health effects, risk management
and, if necessary, withdrawal of products.
Nine legal acts cover the food domain. Three of them relate to specific obligations and
procedures, such as the provision of food information to consumers (Regulation 1169/2011),
risk assessment in the food chain (Regulation 2019/1381), and authorisation of food products
(1331/2008). Another three legal acts lay out specific provisions relevant to food additives,
food flavourings and food enzymes. The rest three regulations cover novel foods that include
any food that was not used for human consumption to a significant degree within the Union
before 15 May 1997, irrespective of the dates of accession of Member States to the Union,
and that falls under at least one of the categories provided in Article 3(2)(a) of Regulation
2015/2283. Novel foods also include traditional foods from third countries (Regulation
2017/2468).
Search and review of relevant websites identified four legal acts related to animal feed.
Regulation 767/2009 covers placing on the market and use of feed. Regulation 1831/2003 on
additives in animal nutrition (a legislative proposal revising this Regulation is under
preparation) sets out a procedure for authorising the placing on the market and use of feed
additives, while Regulation 429/2008 (discussions on amendments to this Regulation are
ongoing) provides detailed rules for the implementation of Regulation 1831/2003. Regulation
1831/2003 also lays down rules for the supervision and labelling of feed additives and
546
premixtures. Finally, Regulation 2019/4 sets out specific provisions regarding medicated feed
and intermediate products.
Furthermore, two legal acts identified by search were excluded from the analysis. It is
Directive 2002/32 on undesirable substances in feed and Regulation 183/2005 on feed
hygiene. According to Article 2(l) of the Directive 2002/32, undesirable substance is “any
substance or product, with the exception of pathogenic agents, which is present in and/or on
the product intended for animal feed and which presents a potential danger to animal or
human health or to the environment or could adversely affect livestock production”.
Undesirable substances may occur in feed products in different ways, e.g., because of
environmental or other contamination in food and feed chain. However, these substances are
not intentionally added to feed products; therefore, they are out of the scope of this analysis.
Regulation 183/2005 lays down the general rules for feed hygiene that is understood as “the
measures and conditions necessary to control hazards and to ensure fitness for animal
consumption of a feed, taking into account its intended use” (Article 3(a), Regulation
183/2005). However, hazard control is associated with specific operations by feed businesses
that may cause hazards (e.g., contamination of feed): “Feed business operators responsible
for primary production of feed shall ensure that operations are managed and carried out in
such a way as to prevent, eliminate or minimise hazards with the potential to compromise
feed safety” (Regulation183/2005, Annex 1, Part A, Section I). However, the Regulation
183/2005 does not address hazards of chemical substances/mixtures; therefore, it is out of the
scope of this study.
Identification and classification of environmental hazards
Regulation 178/2002 on food law lays out general requirements to risk analysis and
assessment of food. However, it explicitly mentions the protection of human health and life
as an objective to be reached through these actions (Article 6). Other food legislation
mentions environmental factors in different contexts (see Table 169).
547
Table 170: Provisions regarding identification and classification of environmental hazards in food
Legislation Provisions
General food legislation
Regulation on
Food Law
178/2002
Article 14 lays out general food safety requirements. Pursuant to Article 14(1), food
shall not be placed on the market if it is unsafe.
Regulation
1829/2003 on
genetically
modified food
and feed
Article 4(1) specifies that
(a) food referred to in Article 3(1) must not have adverse effects on human health,
animal health or the environment.
no person shall place on the market a GMO for food use or food referred to in Article
3(1) unless it is covered by an authorisation granted in accordance with this Section and
the relevant conditions of the authorisation are satisfied;
no GMO for food use or food referred to in Article 3(1) shall be authorised unless the
applicant for such authorisation has adequately and sufficiently demonstrated that it
satisfies the requirements of paragraph 1 of this Article.
Article 5 lays out provisions for applications for authorisations. Article 5(5) specifies
that in the case of GMOs or food containing or consisting of GMOs, the application shall
also be accompanied by:
the complete technical dossier supplying the information required by Annexes III
and IV to Directive 2001/18/EC and information and conclusions about the risk
assessment carried out in accordance with the principles set out in Annex II to Directive
2001/18/EC or, where the placing on the market of the GMO has been authorised under
part C of Directive 2001/18/EC, a copy of the authorisation decision;
a monitoring plan for environmental effects conforming with Annex VII to Directive
2001/18/EC, including a proposal for the duration of the monitoring plan; this duration
may be different from the proposed period for the consent.
Regulation
1830/2003 on
traceability and
labelling of
GMO in food
and feed
N/A
Specific food legislation
Regulation
2015/2283 on
novel foods
Recital (2): A high level of protection of human health and of consumers' interests and
the effective functioning of the internal market needs to be assured in the pursuit of
Union food policies, whilst ensuring transparency. A high level of protection and
improvement of the quality of the environment are among the objectives of the Union
as established in the Treaty on European Union (TEU). It is important that all relevant
Union legislation, including this Regulation, take those objectives into account.
Recital (29): New technologies and innovations in food production should be
encouraged as they could reduce the environmental impact of food production,
enhance food security and bring benefits to consumers as long as the high level of
consumer protection is ensured.
Traditional
foods
Regulation
2017/2468
The Regulation does not contain any explicit links to the assessment of the
environmental risks. Only health risks to consumers are considered in the Regulation.
Regulation
2017/2469 on
requirements for
novel foods
applications
The Regulation does not contain any explicit links to the assessment of the
environmental risks. Only health risks to consumers are considered in the Regulation.
Regulation on a Recital (14): It is recognised that, in some cases, scientific risk assessment alone
548
Table 170: Provisions regarding identification and classification of environmental hazards in food
Legislation Provisions
General food legislation
common
authorisation
procedure
1331/2008
cannot provide all the information on which a risk management decision should be
based, and that other legitimate factors relevant to the matter under consideration
may be taken into account, including societal, economic, traditional, ethical and
environmental factors and the feasibility of controls.
Food Additives'
Regulation
1333/2008
Article 4(1) specifies that only food additives included in the Community list in
Annex II may be placed on the market as such and used in foods under the conditions of
use specified therein.
Article 4(2) provides that only food additives included in the Community list in
Annex III may be used in food additives, in food enzymes and in food flavourings under
the conditions of use specified therein.
Pursuant to Article 6(1), a food additive may be included in the Community lists in
Annexes II and III only if it meets the following conditions and, where relevant, other
legitimate factors, including environmental factors:
(a) it does not, on the basis of the scientific evidence available, pose a safety concern to
the health of the consumer at the level of use proposed;
(b) there is a reasonable technological need that cannot be achieved by other
economically and technologically practicable means; and
(c) its use does not mislead the consumer.
Food
Flavourings'
Regulation
1334/2008
The Regulation does not contain any explicit links to the assessment of the
environmental risks. Only health risks to consumers are considered in the Regulation.
Food Enzymes
Regulation
1332/2008
Recital (6): Food enzymes should be approved and used only if they fulfil the criteria
laid down in this Regulation. Food enzymes must be safe when used, there must be a
technological need for their use and their use must not mislead the consumer. Misleading
the consumer includes, but is not limited to, issues related to the nature, freshness,
quality of ingredients used, the naturalness of a product or of the production process, or
the nutritional quality of the product. The approval of food enzymes should also take
into account other factors relevant to the matter under consideration including societal,
economic, traditional, ethical and environmental factors, the precautionary principle
and the feasibility of controls.
Regulation 1829/2003 requires genetically modified food and feed to be safe for the
environment. The authorisation dossiers must contain environmental risk assessment and
monitoring plans for environmental effects in accordance with this legal act.
Regulation 2015/2283 on novel foods refers to the goal of a high level of protection of the
environment in recitals, however, protection of the environment is not referenced elsewhere
in this regulation. In a similar vein, there are no references to the protection of the
environment in other legal acts regulating novel foods (i.e. Regulations 2017/2468 and
2017/2469).
Regulation on a common authorisation procedure 1331/2008 specifies in the recital part that
environmental factors may be considered where relevant. The same references are found in
Food Additives’ (1333/2008) and Food Enzymes Regulations (1332/2008). Other food legal
549
acts do not contain explicit links to the environment and identification of the environmental
hazards.
Animal Feed Regulation 767/2009 explicitly states that only feed that does not have a direct
adverse effect on the environment or animal welfare can be placed on the market (Article
4(1)). Annex III provides a list of restricted or prohibited materials for use for animal
nutritional purposes. In turn, feed intended for particular nutritional purposes may only be
marketed as such if its intended use is included in the list of intended uses established by the
Commission in the Regulation (EU) 2020/354. The list can be updated by submitting to the
Commission an application demonstrating that a feed product has no adverse effects on
animal health, human health, the environment or animal welfare.
Feed legislation that regulates genetically modified organisms in the feed also sets a general
requirement for feed products to be safe and do not have adverse effects on human health,
animal health or the environment. The compliance with these requirements is to be proved by
the results of the risk assessment (including environmental risk assessment).
Table 171: Provisions regarding identification and classification of environmental hazards in animal feed
Legislation Provisions
General feed legislation
Regulation
178/2002 on Food
Law
Article 15 sets out general safety requirements for animal feed. According to Article
15(1), feed shall not be placed on the market or fed to any food-producing animal
if it is unsafe.
Animal Feed
Regulation
767/2009
Article 4(1) lays out the requirements for animal feed to be placed on the market.
According to Article 4(1), feed may only be placed on the market and used if: (a) it is
safe, and (b) it does not have a direct adverse effect on the environment or animal
welfare.
The requirements set out in Article 15 of Regulation (EC) No 178/2002 shall apply,
mutatis mutandis, to feed for non-food producing animals
Pursuant to Article 6(1), feed shall not contain or consist of materials whose placing on
the market or use for animal nutritional purposes is restricted or prohibited. The list of
such materials is set out in Annex III.
Following Article 9, feed intended for particular nutritional purposes may only be
marketed as such if its intended use is included in the list of intended uses established
in accordance with Article 10 and if it meets the essential nutritional characteristics for
the respective particular nutritional purpose outlined in that list.
According to Article 10(2), the list of intended uses can be updated by the submission
to the Commission of an application by a natural or legal person established in the
Community or by a Member State. A valid application shall include a dossier
demonstrating that the specific composition of the feed fulfils the particular
intended nutritional purpose and that it has no adverse effects on animal health,
human health, the environment or animal welfare.
Regulation
1829/2003 on
genetically
modified food and
feed
Article 16 specifies that:
Feed referred to in Article 15(1) must not: (a) have adverse effects on human health,
animal health or the environment;
No person shall place on the market, use or process a product referred to in Article
15(1) unless it is covered by an authorisation granted in accordance with this Section
and the relevant conditions of the authorisation are satisfied.
No product referred to in Article 15(1) shall be authorized unless the applicant for such
authorisation has adequately and sufficiently demonstrated that it satisfies the
requirements of paragraph 1 of this Article.
550
Table 171: Provisions regarding identification and classification of environmental hazards in animal feed
Legislation Provisions
General feed legislation
Article 17(5) specifies that in the case of GMOs or feed containing or consisting of
GMOs, the application shall also be accompanied by:
the complete technical dossier supplying the information required by Annexes III
and IV to Directive 2001/18/EC and information and conclusions about the risk
assessment carried out in accordance with the principles set out in Annex II to
Directive 2001/18/EC or, where the placing on the market of the GMOs has been
authorised under part C of Directive 2001/18/EC, a copy of the authorisation decision;
a monitoring plan for environmental effects conforming with Annex VII to
Directive 2001/18/EC, including a proposal for the duration of the monitoring plan;
this duration may be different from the proposed period for the consent.
Regulation
1830/2003 on
traceability and
labelling of GMO
in food and feed
N/A
Specific animal feed legislation
Regulation
1831/2003 on
Additives in
Animals Nutrition
Article 5 sets the requirements to feed additives to be placed on the market. Pursuant to
Article 5(2)(a), a feed additive must not have an adverse effect on animal health,
human health or the environment.
Article 7(3)(d) indicates that a copy of the studies which have been carried out and any
other material which is available to demonstrate that the feed additive satisfies the
criteria laid down in Article 5(2) and (3) must be submitted as a part of an authorisation
application.
Regulation
429/2008 on the
implementation
rules of
Regulation
1831/2003
Annexes II and III set requirements for the dossier accompanying the application for
authorisation and studies to be included in it.
The general requirements of Annex II specify that safety assessment is to be based on
studies intended to demonstrate the safety of the use of the additive in relation to <…>
(e) the environment, as a result of the additive itself or products derived from the
additive, either directly and/or as excreted by animals.
Annex II, Section III: Studies concerning safety of the additive, part 3.4 describes that
to determine the environmental impact of additives, a stepwise approach shall be
followed. All additives have to be assessed through Phase I to identify those additives
which do not need further testing. For other additives, a second phase (Phase II)
assessment is needed to provide additional information, based upon which further
studies may be considered necessary. These studies shall be conducted according to
Directive 67/548/EEC [= replaced by the CLP Regulation – author note]
<…>Paragraph 3.4.1. The purpose of Phase I assessment is to determine if a significant
environmental effect of the additive or its metabolites is likely and whether a Phase
II assessment is necessary.
<…>Paragraph 3.4.2. The aim of Phase II is to assess the potential for additives to
affect non-target species in the environment, including both aquatic and terrestrial
species or to reach groundwater at unacceptable levels.
Medicated feed
Regulation
(2019/4)
No additional requirements are provided. However, all general requirements laid out in
feed legislation apply.
Pursuant to Article 1, the provisions of Medicated feed Regulation are additional to
Union legislation on feed and apply without prejudice in particular to Regulations (EC)
No 1831/2003, (EC) No 183/2005 and (EC) No 767/2009 and Directive 2002/32/EC.
551
Regulation 1831/2003 on Feed additives specifies in Article 5 that to be placed on the market
a feed additive must not have an adverse effect on animal health, human health or the
environment. In turn, Regulation 429/2008 sets the requirements for authorisation dossiers
to be submitted by applicants intending to place a feed additive on the market.
The guidance on the safety assessment of feed additives by the EFSA details that an
environmental risk assessment (ERA) should be conducted for (1) terrestrial compartment
(via spreading of animal manure contaminated with feed additives on agricultural soils), (2)
the aquatic compartment (via drainage and run-off from agricultural fields to surface water,
via a direct discharge of waste water from land-based fish farms to surface water, or via
excreta from fish farmed in cages to sediment), and (3) the groundwater compartment (via
leaching from the soil) (Bampidis et al., 2019) (see Paragraphs 3.4.1.1. and 3.4.1.2. of Annex
II, Section III).
If the EFSA’s opinion concludes that the additive is not safe for the environment, one of the
conditions for authorising the additive (laid down in Article 5 of Regulation 1831/2003) is
not met and the measure to be adopted by the Commission on the basis of Article 9 must take
it into account (cf Article 9(1) of Regulation 1831/2003), either by denying the requested
authorisation or by requiring specific conditions/restrictions linked to the authorisation.
No specific additional REQUIREMENTS were set in Regulation 2019/4 on Medicated feed.
Labelling and communication of the environmental hazards of the products to
downstream users
Following the review of food and feed legislation two definitions of labelling were identified:
Regulation 1169/2011 on food information to consumers: ‘label’ means any tag, brand, mark,
pictorial or other descriptive matter, written, printed, stencilled, marked, embossed or
impressed on, or attached to the packaging or container of food (Article 1(i)); ‘labelling’
means any words, particulars, trademarks, brand name, pictorial matter or symbol relating to
food and placed on any packaging, document, notice, label, ring or collar accompanying or
referring to such food (Article 1(j)).
Animal Feed Regulation 767/2009: ‘labelling’ means the attribution of any words,
particulars, trademarks, brand name, pictorial matter or symbol to a feed by placing this
information on any medium referring to or accompanying such feed, such as packaging,
container, notice, label, document, ring, collar or the Internet, including for advertising
purposes (Article 3(2)(s)); ‘label’ means any tag, brand, mark, pictorial or other descriptive
matter, written, printed, stencilled, marked, embossed, impressed on, or attached to the
packaging or the container of feed (Article 3(2)(t)).
It is important to note that Regulation 178/2002 on Food Law specifies in Articles 14(1) and
15(1) that no food or feed products must be placed on the market if they are not safe.
Regulation 1169/2011 and 767/2009 provide extensive guidance on labelling food and feed
products, respectively:
Regulation 1169/2011 on food information to consumers specifies that the provision of food
information shall pursue a high level of protection of consumers’ health and interests by
providing a basis for final consumers to make informed choices and to make safe use of food,
552
with particular regard to health, economic, environmental, social and ethical considerations
(Article 3(1)).
Regulation 767/2009 sets the objective to harmonise the conditions for the placing on the
market and the use of feed, to ensure a high level of feed safety and thus a high level of
protection of public health, as well as to provide adequate information for users and
consumers and to strengthen the effective functioning of the internal market. In Articles 15-
22 it sets extensive requirements for labelling of feed products; however, the Regulation
767/2009 does not provide specific required label elements for addressing the environmental
hazards of feed.
Regulations related to specific feed products, such as feed additives and medicated feed
provide some label elements that may potentially address the environmental hazards:
 Regulation 1831/2003 on Additives in Animals Nutrition provides one labelling
requirements that can potentially relate to communication of the environmental
hazards. Pursuant to Article 16(1)(e), “directions for use, and any safety
recommendations regarding the use” must be provided on the label of feed additives
and premixtures.
 Regulation 2019/4 on medicated feed lays out specific labelling provisions in Article
9(1), which indicates that medicated feed must comply with the labelling
requirements listed in Annex III. In turn, Annex III gives a list of specific particulars
that must be present on the label. Among various elements, the label must include
“information that inappropriate disposal of medicated feed poses serious threats to the
environment and may, where relevant, contribute to antimicrobial resistance” (Annex
III, Specific labelling requirements referred to in Article 9(1), (10)).
The review of legal acts did not find any substantial and systematic approach to
labelling requirements for communicating the environmental hazards of the food and
feed.
Evidence on the gaps in protection from the environmental hazards
Evaluation, impact assessment and technical and scientific studies that related to food and
feed legislation were identified and screened to find evidence of potential gaps in the
protection from the environmental hazards borne by food and/or feed products. The Farm to
Fork Strategy (EC, 2020g) highlighted several environmental issues throughout the whole
food chain. Analysis of the evaluation and other relevant reports revealed several topics
related to the environmental hazards of food and/or feed products:
Shortcomings in public communication about risks caused by food/feed products by EFSA
(EC, 2018e; EC, 2018f). This criticism originated from the public consultation with the
stakeholders in the course of the re-fit evaluation of the General Food Law. Public authorities
and citizens expressed opinions on the lack of clarity and adjustment to different needs of
target audiences in communication, in some cases, communicating contradictory information
as well as the lack of transparency in some communication processes. This issue relates to the
effectiveness of communication of EFSA but it does not consider that risk communication
has specific shortcomings due to regulatory gaps.
The Farm to Fork Strategy (EC, 2020g) highlighted sustainability challenges in the food
production chain, including the use of chemical pesticides and nutrients that cause air, water
553
and soil pollution and harm to plants and animals, greenhouse gas emissions in the course of
agricultural activities, excessive use of antimicrobials in animals. Similarly, a recent
Eurobarometer survey (2019) showed that EU citizens are well-aware and concerned about
such issues as antibiotic, hormone or steroid residues in meat (44%), pesticide residues in
food (39%), environmental pollutants in fish, meat or dairy (37%). Forty-three per cent of
Europeans (43%) think that food products are full of harmful substances (Kantar, 2019).
The Food waste issue is in part pre-conditioned by wasteful behaviour of consumers and has
been caused by misunderstanding of food date (‘best before’ and ‘use by’) labels (EC, 2020h;
Purnhagen & Schebesta, 2019; Anthesis et al., 2018; EC, 2015c; European Court of Auditors,
2016). EC (2020h) referred to the findings of the Eurobarometer survey 2015, which
suggested that less than one in two consumers understand the meaning of date marking: “use
by”, which indicates the ultimate food safety date, and “best before”, which refers to the date
food retains its optimal quality. The study performed by Anthesis et al. (2018) for the
Commission concluded about 10% of all food waste generated in the EU could be related to
date marking on the product labels. The Joint Research Centre study carried out for the
Commission in 2020 indicated that the effect of labels on the consumer decision may lessen
when several concurrent labels (e.g., environmental and nutrition) are presented on the
package. Furthermore, JRC pointed out that the environmental effect of food labels has not
been widely researched. The review of date marking on labels has been included within the
scope of the revision of Regulation (EU) No 1169/2011 on the provision of food information
to consumers (EC, 2020h).
Insufficient information to professionals and end-users of food and feed on the hazards
borne by these products (RPA et al., 2017). The findings of the stakeholder survey in the
report supporting the impact assessment of chemicals legislation (except REACH) revealed
that public authorities and NGOs considered that current information on labels of food and
feed is not sufficient to disclose hazards of these products to their users. This opinion was not
supported by any quantitative evidence.
The analysis of the European Commission policy documents and studies showed that the
issues of sustainability in the food chain and food waste are not related to the scope of
the CLP Regulation because the reason of the environmental harm is not due to hazardous
properties of food, but the peculiarities of food production activities, volumes of food waste
produced by inappropriate consumer behaviour and other reasons.
Similarly, the issues of food-wasting behaviour of consumers and labelling are associated
with the volumes of produced waste that becomes an environmental problem. The scientific
papers and grey literature dedicated to the food-wasting behaviour of consumers are
voluminous. This search concentrated on literature reviews and European level quantitative
studies. The search identified four extensive systematic literature reviews covering the period
of 1980 – 2019 and between 112 to 309 papers (Principato et al., 2021; Boulet et al., 2021;
Schanes et al., 2018; Hebrok et al., 2017), one quantitative modelling research of the datasets
of Eurobarometer surveys (Toma et al., 2020) and two legislation and literature reviews
(Bremmers & Purnhagen, 2018; Wunder et al., 2018). Although all these analyses consider
consumer food-wasting behaviour and labelling, they do not attribute food-wasting
behaviour to the lack of or inappropriate food hazard communication to the consumer.
When asked about possible gaps in information provision on the hazards of food or feed, such
as additives (‘when buying or using the product categories listed below, you might not be
informed that they could be hazardous to the environment. What is your opinion?’), many
554
citizens (59%), public authorities (45%) and civil societies (69%) who participated in the
open public consultation considered that this issue should be immediately solved.
DEFINITIONS RELEVANT TO THE APPLICATION OF EXEMPTIONS
Problem and its scope
The initial research hypothesis for this study was that “it is not always clear how the
exclusion provisions must be applied, inter alia, because some definitions diverge between
CLP and specific products legislation (in particular the wording of ‘in the finish state’ and
‘intended for the final user’)”.
According to the reports on the national helpdesk activities published by ECHA, in 2018,
2019 and 2020, the theme ‘scope and exemptions of CLP’ was in the list of ten hot topics that
cover most asked questions by the customers of helpdesks. There is no uniform system for
tracking questions to national helpdesks, so the annual reports are compiled by surveys of
national representatives of helpdesks and the answers reflect their opinion and practical
experiences. In 2018, 2019 and 2020 (in 2019 and 2020 the theme was combined with
another topic ‘general questions on CLP’) this topic was the fifth on the list (ECHA, 2021b,
2020, 2019b). The available evidence does not allow to confidently conclude that the
issues of CLP scope exemptions were among the most significant for duty holders who
contacted helpdesks.
When addressing this issue, it is important to consider that:
In Article 1(5) addressing the application of exemptions, the CLP Regulation does not define
the legal wordings ‘in the finish state’ and ‘intended for the final user’, although they are
intended to serve for making a distinction between products that are exempted from the CLP
Regulation or those that must comply with it. This circumstance poses a problem for making
a proper distinction between the above-mentioned products.
Scopes and objectives of the legislation regulating the exempted products are broad and cover
a lot of issues within and beyond hazard identification and communication. Therefore, the
concepts applied in the CLP Regulation may diverge and be used differently or not used at
all.
Based on these observations, two questions need to be answered to clarify the issue of the
application of the CLP exemption provisions:
What issues are faced by the duty holders because of the absence of definitions of ‘in the
finished state’ and ‘intended for the final user’ in Article 1(5) of the CLP Regulation?
Does on the products exempted from the CLP Regulation provide any concepts related to ‘in
the finished state’ and ‘intended for the final user’ that could facilitate decisions on the
application of the CLP exemption provisions?
Analysis of relevant definitions
To answer the questions introduced in the previous section the following research was
performed:
Analysis of the practical examples of uncertainties that might occur in deciding whether in
some cases the CLP Regulation applies to the products listed in Article 1(5) (medicinal and
555
veterinary medicinal products, cosmetics, food and feed, medical devices). Practical
examples and their interpretations were collected from the Questions & Answers section by
ECHA (see Appendix 2 to Annex 4).
Analysis of definitions related to products ‘in the finished state’ and/or ‘intended for the final
user’ in the legislation regulating the exempted products.
The analysis of practical examples related to the application of the CLP Regulation to the
products listed in Article 1(5) has shown two major uncertainty areas: a) changes to the
product that determine its finished/unfinished condition; b) circumstances that should
be considered as (non)final use situation. Interpretation of practical examples by ECHA
suggests that a product is in its finished state when no alterations to its chemical composition
occur. Following this approach, for instance, bulk cosmetics or medicinal products are in the
finished state, even if they are further processed by packaging. In turn, a product is intended
for the final user when it is placed on the market to be sold to professional end-users or
consumers, but not other business entities that could further process it for developing other
products. Depending on circumstances, the same product may be interpreted as intended or
not intended for the final users. For instance, essential oils may be offered to end-users as a
cosmetic product or may be used as an ingredient for cosmetic products. In the first case,
essential oils are intended for the final users, while in the second case – not.
Based on the practical understanding of the CLP references to products ‘in the finished state’
and ‘intended for the final user’, the legal acts regulating the exempted products were
analysed to find relevant definitions (see Table 171).
556
Table 172: Definitions of the product condition and uses in the exempted products’ legislation
Regulation Definition
Product users
Cosmetics Regulation
1223/2009
‘End user’ means either a consumer or professional using the cosmetic
product (Article 2(1)(f)).
Regulation on Medical
Devices 2017/745 and
Regulation on In vitro
Medical Devices 2017/746
‘User’ means any healthcare professional or lay person who uses a device
(Article 2(37) of the Regulation 2017/745 and Article 2(30) of the Regulation
of 2017/746).
Regulation 178/2002 on
General Food Law
‘Final consumer’ means the ultimate consumer of a foodstuff who will not
use the food as part of any food business operation or activity.
Food Additives’ Regulation
1333/2008
Distinguishes between ‘food additives not intended for sale to the final
consumer’ (Article 21) and ‘food additives intended for sale to the final
consumer’ (Article 23), but does not provide a definition
Food Flavourings'
Regulation 1334/2008
Distinguishes between ‘flavourings not intended for sale to the final
consumer’ (Article 14) and ‘flavourings intended for sale to the final
consumer’ (Article 17), but does not provide a definition
Food Enzymes Regulation
1332/2008
Distinguishes between ‘food enzymes and food enzyme preparations
not intended for sale to the final consumer’ (Article 10) and ‘food
enzymes and food enzyme preparations intended for sale to the final
consumer’ (Article 12)
Regulation 1831/2003 on
Additives in Animal
Nutrition
‘Premixtures’ means mixtures of feed additives or mixtures of one or more
feed additives with feed materials or water used as carriers, not intended for
direct feeding to animals (Article 2(2)(e).
Product state or condition
Medicinal Products
Directive 2001/83/EC
According to Article 3(4), this Directive shall not apply to intermediate
products intended for further processing by an authorized manufacturer
(Article 3(4)).
Veterinary Medicinal
Products Regulation 2019/6
According to Article 2(7)(e), this Regulation shall not apply to medicated
feed and intermediate products as defined in points (a) and (b) of Article
3(2) of Regulation (EU) 2019/4.
Regulation 2019/4 provides the following definition of ‘intermediate
products’ that is focused on medicated animal feed (Article 3(2)(b)):
‘Intermediate product’ means a feed, which is not ready to be directly fed
to animals without further processing, consisting of a homogenous mixture of
one or more veterinary medicinal products with feed materials or compound
feed, exclusively intended to be used for the manufacture of medicated feed.
Regulations of most products, except legal acts on medicinal products, define a user and refer
to final/end-use situations. In legislation on cosmetics and medical devices users are
understood as professionals and consumers/lay persons. The most extensive definition of the
final consumer that could be useful for understanding the conditions for CLP exemptions
under Article 1(5) is the definition of the final consumer in the Regulation on General Food
Law. It emphasises that the situation of the final consumption excludes any use of a product
in business operations or activities. ECHA recognised the usefulness of this definition in
practice when deciding whether a specific product should be treated as an exemption from the
557
CLP Regulation.166
The definition of the final user in the Regulation on General Food Law
applies to other sectorial food and feed legislation. Subsequently, food and feed legal acts
distinguish between products intended/not intended for the final user. This distinction serves
various purposes, for instance, in food legislation different labelling requirements are
provided for food additives, flavourings and enzymes in cases when they are intended or not
intended for a final consumer.
In the inception impact assessment of the Feed additives Regulation 1831/2003 the
insufficient legal clarity with the CLP Regulation was mentioned with regard to feed
additives and premixtures that may lead to contradictory directions when both regulations
apply simultaneously (European Commission, 2020). The lack of legal clarity and application
of both regulations to feed additives and premixtures is going to be addressed in evaluation of
the Feed additives Regulation. The consultation activities to support the revision of the CLP
Regulation, including expert interviews, did not demonstrate any issues for the duty holders
in this domain.
Veterinary and medicinal products legislation introduces a concept of intermediate products.
This definition serves the purpose of defining the products to which the legal acts do not
apply. Intermediate products are those that require further processing of a product before
being used by a final consumer (e.g., before being directly fed to animals). Although this
definition brings more clarity, it, however, does not refer to the nature of processing that a
product undergoes. Analysis of ECHA questions and answers indicates that the nature of
processing activities is important for deciding whether a product must comply with the CLP
Regulation.
In sum, the definitions provided in the exempted products legislation do not bring more
clarity for understanding, which legislation applies to a product. In the exempted products’
legislation, the definitions that can potentially relate to the concepts ‘in the finished state’ and
‘intended for the final user’ serve different purposes than linking with the provisions of the
CLP Regulation.
CONCLUSIONS
In this section, the information is organised in form of answers to the two research questions.
RQ1: Does the sectorial legislation that regulates the exempted products provide the
same level of protection from the environmental hazards borne by these products as the
CLP Regulation?
The analysis revealed that identification of the environmental hazards is addressed in the
legislation referring to human and veterinary medicinal products, genetically modified food
and feed, and animal feed in general. In all these legal acts, environmental risk assessment,
which combines the assessment of hazards and exposure, is required. In food legislation,
environmental factors may be considered, if relevant. The legal acts concerning cosmetic
166
CLP: scope and exemptions under CLP. Questions & Answers. Available at:
https://echa.europa.eu/support/qassupport/browse?p_p_id=journalqadisplay_WAR_journalqaportlet&p_p_lifecy
cle=0&_journalqadisplay_WAR_journalqaportlet_topic=CLP&_journalqadisplay_WAR_journalqaportlet_scop
e=Scope+and+exemptions+under+CLP&_journalqadisplay_WAR_journalqaportlet_backURL=https%3A%2F
%2Fecha.europa.eu%2Fsupport%2Fqassupport%2Fbrowse%3Fp_p_id%3Djournalqadisplay_WAR_journalqap
ortlet%26p_p_lifecycle%3D0%26p_p_state%3Dnormal%26p_p_mode%3Dview [Accessed on: 30 November
2021]
558
products, medical devices and food (as well as food additives) do not have a special focus on
the identification of the environmental hazards. However, in legislation on medical devices
and food some environmental hazards may be still considered if relevant. In addition,
Environmental concerns for cosmetic ingredients are tackled by REACH (e.g. via restrictions
based on hazard and risks for the environment). For a summary see Table 172.
Regarding communication of the environmental hazards, specific precautions or warnings
related to the safe use, storage and disposal are required for human and veterinary medicinal
products on the label or in the instructions for use, while communication of the
environmental hazards related to safe disposal of in vitro medical devices is required as well.
For other products, the analysis of legal acts has not identified specific labelling
requirements, except for feed additives and medicated feed. For a summary see Table 172.
Table 173: A summary of environmental hazard identification and communication in the legislation on the
products exempted from the CLP Regulation
Product
Identification of
environmental hazards
Communication of environmental hazards
Medicinal
products for
human use
Required through ERA Precautions on use, storage, disposal on the label
Veterinary
medicinal
products
Required through ERA
Precautions on use, storage or any other important
information on the label or in the instruction for use
Medical
devices
No specific focus on the
environmental hazards
For in vitro medical devices, warnings or precautions
related to environmental hazards that facilitate the safe
disposal of the device must be provided in the instructions
for use. In case a device contains a substance or a mixture
that may be considered dangerous, relevant hazard
pictograms shall be put on the label and the other
information required by Regulation (EC) No 1272/2008
shall be given in the instructions for use.
Food
Required through ERA for
genetically modified food.
May be considered where
relevant in risk assessments
and application dossiers for
food additives and food
enzymes
No specific requirements
Animal feed Required through ERA
No specific requirements, except for feed additives
(directions for safe use) and medicated feed (disposal
recommendations)
Cosmetics
Reference to REACH for
environmental
considerations (e.g. REACH
restriction)
No specific requirements
In summary, the following requirements apply to the different types of exempted products:
Human and veterinary medicinal products. The effects of HMPs and VMPs on the
environment are addressed in the environmental risk assessment, which must be submitted as
a part of the marketing authorisation dossier. The assessment of environmental risks
considers the evaluation of environmental hazards of chemicals and their environmental
exposure. The outcomes of the environmental risk assessment of a HMP or a VMP lead to
specific labelling requirements and risk mitigation measures. Hazard communication
requirements for HMPs and VMPs cover use, storage and disposal precautions. In some
559
cases, information can be provided in the instructions for use. Therefore, labels of such
products do not provide information on the environmental hazards of the products to the
extent as in the CLP Regulation.
Cosmetics. The CPR does not address the identification and communication of the
environmental hazards by explicitly stating in Recital 5 that the environmental concerns are
addressed under REACH in a cross-sectoral manner.
Medical devices. The Regulations on Medical Devices (2017/745) and In Vitro Medical
Devices (2017/746) does not explicitly focus on environmental hazards; however, some
safety requirements to medical devices (incl. in vitro medical devices) addressing the safety
of disposal and/or emissions might be relevant to the protection of the environment. It is
important to note, however, that the safety assessment of medical devices is focused on the
protection of the health of patients, users and other persons involved in the use and disposal
of a device. Differently from the CLP Regulation, the label or instruction for use of a medical
device, following the regulations 2017/745 and 2017/746, communicates information
relevant to safe use, storage, handling and disposal of the device. So, the professional user or
a consumer does not have access to information about environmental hazards on the label. An
exception are in vitro medical devices containing substances or mixtures, which may be
considered dangerous. In such cases, hazard pictograms are put on the label and other
information under the CLP Regulation should be provided in the instructions for use.
Food and feed. In food legislation, the identification of environmental hazards is a part of the
environmental risk assessment required by Regulation 1829/2003 on genetically modified
food and feed. Other food legislation does not cover environmental risk assessment, although
some legal acts, e.g., Regulation on a common authorisation procedure 1331/2008, Food
Additives’ (1333/2008) and Food Enzymes (1332/2008) Regulations specify that
environmental factors may be considered if relevant in the approval of authorisation
applications (Regulations 1333/2008 and 1332/2008) or as a part of scientific risk
assessments (Regulation 1331/2008). All analysed animal feed legal acts provide an explicit
requirement for animal feed and animal feed additives to be safe for the environment. The
analysis of the effects on the environment must be provided in authorisation applications. The
analysis of food and feed legislation did not detect any specific labelling requirements
addressing the environmental effects, except general safe use recommendations in Feed
Additives Regulation (1831/2003) and disposal precautions in Medicated feed Regulation
(2019/4).
Analysis of the available evidence revealed that some exempted product types may have
adverse effects on the environment (see Table 173 for a summary of evidence analysis). For
medicinal products and food, there is solid quantitative evidence on the negative effects
on the environment. However, food waste or sustainability gaps in the food production
chain are not caused by hazardous properties of food. Scientific peer-reviewed studies
and some grey literature reports reveal the adverse effects of plastic microbeads (to be
mentioned that those ingredients are affected by the REACH restriction on microplastics) and
UV filters both used in personal care cosmetic products. However, no estimate of the overall
environmental impact of cosmetic products on the environment was found. No evidence
about the environmental hazards of medical devices could be found.
Table 174: A summary of the findings of an analysis on potential gaps in protection from the environmental
hazards
Question HMP & VMP Cosmetics Medical devices Food and feed
560
Are there any
environmental
issues caused by the
exempted products?
Yes, pollution of
aquatic
environments by
pharmaceuticals
No solid and
quantitative
evidence of all
issues: UV filters
and plastic
microbeads are
visible in the
research
No evidence,
difficult to
distinguish
common issues for
a highly diverse
group of devices
Food waste
No evidence for
issues caused by
feed
Are the identified
environmental
issues caused by
hazards of the
exempted products?
Yes
At least for UV-
filters and plastic
microbeads used in
cosmetic products,
there is some
evidence
No evidence
No evidence, food
waste is a problem
mainly due to its
volume
Are the identified
environmental
issues caused by the
lack of
communication
about the hazards of
the exempted
products?
No evidence No evidence No evidence No evidence
Could the
environmental
issues be solved by
enhancing
identification or
communication of
hazards as laid out
in the CLP
Regulation?
No evidence,
although hazard
communication by
label information
could be one of the
measures
No evidence No evidence No evidence
The adverse environmental effects of the medicinal products (intended for human use in
particular) are caused by the hazardous properties of these products and mostly result from
the inappropriate disposal behaviour of such products in households. However, the studies of
disposal behaviours are fragmented and non-representative. Besides, the available empirical
research of consumer behaviour does not prove the link between the lack of
awareness/information about the environmental effect of medicines as a cause of
inappropriate disposal habits. Instead, controversial results from different research suggest
that medicine disposal behaviour depends on multiple interrelated factors and is not limited to
the level of environmental awareness. Interestingly, the research about consumer behaviour
in purchasing cosmetic products and consumer food-wasting behaviour also indicate that
there is no direct causal link between the level of awareness of the environmental issue and
purchase and use behaviour, which is affected by multiple complex factors.
Furthermore, it is useful to mention that regulatory initiatives aimed at improving the
environmental risk assessment and influencing medicines’ disposal behaviour are foreseen in
the forthcoming revision of pharmaceutical legislation. Similarly, a restriction proposal for
plastic microbeads has been submitted by ECHA, also covering cosmetic products.
RQ2: Do the definitions in the CLP Regulation and sectorial legislation covering the
exempted products (particularly those related to ‘in the finished state’ and ‘intended for
561
the final user’) provide sufficient clarity to decide whether the CLP exemptions apply to
a product?
There is no solid evidence that the application of the CLP exemptions under Article 1(5)
causes uncertainties or issues to the duty holders. The only source about duty holders’
concerns – annual reviews of national helpdesks activities published by ECHA – do not allow
to conclude that duty holder experience any issues related to the concepts of ‘in the finished
state’ and ‘intended for the final user’. Sectorial legislation on the exempted products
provides some definitions related to the final use or finished state of the product, however,
these definitions serve different purposes than making a link with the CLP Regulation. The
Question & Answer section maintained by ECHA provides all necessary explanations to duty
holders how to interpret Article 1(5).
The lack of legal clarity and inconsistencies between the Feed Additives Regulation and the
CLP Regulation have been addressed by the Commission in the ongoing evaluation of the
Feed Additives Regulation 1831/2003 in order to avoid regulatory gap and to bring
regulatory simplification.
Therefore, there is no evidence to justify the need for a regulatory action.
562
Annex 15 – Information on online sales of chemicals
CONTEXT
The objective of the matter described in this annex to adapt CLP to online sales and to ensure
safe purchase and use of chemicals sold online is closely linked to Green Deal’s goal of
having a green and digital transition of the EU industry whilst ensuring consumer and
environmental protection. It also links to SDGs #3 Good health and well-being and SDG #9
Industry, innovation and infrastructure as outlined under Section 1.1. of the SWD.
The relevance of online sales has been steadily growing both for individuals and businesses.
According to Eurostat, in 2020, 73% of Internet users in the EU shopped online, while online
purchases increased by 20% in comparison to 2010. Thirty-one per cent (31%) of online
shoppers bought goods from sellers in other EU countries (Eurostat, 2021).167
According to
the EU consumer survey, in 2018, 18.4% of Europeans purchased services or goods online
outside of the EU (GfK Belgium, 2018). One in five EU enterprises made online sales in
2020, amounting to 18% of total turnover of companies that employ 10 or more people168
.
The trend of increased online sales, in particular to consumers, is also noted in UN's Global
Chemicals Outlook (UNEP, 2019).169
The Fitness check of the most relevant chemicals legislation (excluding REACH) states that:
“Regarding online chemicals sales, several enforcement surveys show that various non-
authorised chemicals and related products are increasingly being offered for sale via the
Internet. As chemicals legislation does not distinguish between different types of trade, all
provisions regulating chemicals apply in principle also to Internet trade. Currently, however,
access to websites and relevant information on transactions, vendors or service providers for
monitoring authorities is difficult and therefore hampers their investigations”170
.
The findings to the Fitness check171
report that “articles imported into the EU, including via
online sales, still represent a particular challenge for market surveillance authorities for
ensuring both overall consumer protection as well as fair competition”.
Section 2.3.2. of the Chemicals Strategy for Sustainability (CSS) mentions that “currently
almost 30% of the alerts on dangerous products on the market involve risks due to chemicals,
with almost 90% of those products coming from outside the EU and imported articles and
online sales representing a particular challenge”. And further that “The Commission is
considering which additional measures could be put in place to strengthen the enforcement of
REACH at the EU’s borders, as well as to promote cooperation with online market
platforms” as well as “the Commission will: […] target known areas of high risk of non-
compliance, in particular online sales, imported articles, classification and labelling and
restrictions”.
167
Eurostat (2021). E-commerce statistics for individuals. Available at: https://ec.europa.eu/eurostat/statistics-
explained/index.php?title=E-commerce_statistics_for_individuals#General_overview
168
European Commission, Online sales continue to grow among EU enterprises - Products Eurostat News -
Eurostat (europa.eu)
169
United Nations Environment Programme, Global Chemicals Outlook II – From Legacies to Innovative
Solutions: Implementing the 2030 Agenda for Sustainable Development, 2019, p. 550-551.
170
Commission’s Staff Working Document, SWD(2019) 199 final/2, p. 19.
171
COM(2019)264.
563
For the purpose of clarity of this annex, the term chemicals refers to substances and mixtures
covered under CLP.
PROBLEM DEFINITION, PROBLEM DRIVERS, CONSEQUENCES
Two problems were identified in relation to closing communication gaps for online sales.
First (problem 1), consumers are unable to make informed choices when purchasing
chemicals online, since online offers/advertisements do not have to display all labelling info
and the consumer is not immediately made aware of the hazards, in comparison to brick-and-
mortar sales. This leads to an uneven level playing field between companies offering
chemicals online and companies offering them in traditional shops, whereby online shops
have a competitive advantage over traditional shops, as well as to insufficient protection of
consumers who may only be able to check the labels once they receive the chemical, i.e. only
after the termination of the sale.
The concepts of offers and advertisements need to be distinguished. The former is intended to
conclude a purchase contract so that when the offer is accepted by the buyer the sale is
concluded, while the latter covers promoting messages before the offer and the actual sale.
Offers should contain more hazard information than advertisements given the different
purpose of the two. CLP currently only provides for a provision on advertising for all types of
sale and does not mention online offers explicitly.
Incompliances of online advertisements with advertisement provisions of CLP (Article 48,
advertisement172
) amount to very high numbers. Strictly speaking, incompliances with CLP
provisions in the case of online offers, on the other hand, could not possibly be researched in
the first place, given that currently CLP does not provide for any explicit obligation on how
to display labelling information when offering online. Hence, the best available benchmark to
reveal the scale of the problem is data on advertisement incompliances. Findings of
international e-commerce enforcement projects suggest that non-compliance with CLP
provisions regarding advertisements is found in chemicals sold both by EU and non-EU
actors online. International research projects focused on online sales by the Forum for
Exchange of Information on Enforcement, responsible for enforcement of chemical
legislation, found173
that 75% of 2752 inspected products in 29 EEA countries were non-
compliant with Article 48 (ECHA, 2021e), 82.4% of 1314 inspected products in 15 EU
countries were non-compliant with Article 48(2) on advertisement of mixtures (ECHA,
2018). A collaborative project by national enforcement authorities of Sweden, Norway,
Finland and Denmark revealed that 75% (25 products) of 33 chemicals inspected for
compliance with Article 48(2) of the CLP Regulation174
were not compliant (Klar et al.,
172
Article 48: 1. Any advertisement for a substance classified as hazardous shall mention the hazard classes or
hazard categories concerned.
2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) which allows a member
of the general public to conclude a contract for purchase without first having sight of the label shall mention the
type or types of hazard indicated on the label.
The first subparagraph shall be without prejudice to Directive 97/7/EC of the European Parliament and of the
Council of 20 May 1997 on the protection of consumers in respect of distance contracts (1).
173
The most recent study (ECHA, 2021e) declared in the methodology that many EU countries adopted a risk-
based approach to the check, meaning that they targeted products for which risks could be high. This resulted in
higher rates of non-compliance being found.
174
Risk-based approach to product sampling for investigation was applied (i.e. products that posed higher risks
as experienced in previous research were included), which means that the sample is not generalisable to the
whole market.
564
2020). However, in this case, the number of inspected products was very low to reflect the
situation in the countries covered by the project. Those projects did not differentiate between
online sales made by sellers outside the EU and sellers in the EU.
Second (problem 2), consumers are exposed to chemicals with no or incorrect classification,
labelling and packaging when buying from non-EU actors shipping chemicals directly into
the EU. CLP does not apply to those non-EU actors.. Thus, when they directly ship chemicals
to the EU consumers there is no intermediary in the EU who qualifies as importer with the
result that the consumer becomes the importer175
. This again leads to an uneven level playing
field, i.e. to a competitive advantage for non-EU actors operating online and a disadvantage
for EU actors such as importers (the latter not including consumers, as their purchases do not
qualify as commercial transactions), downstream users, distributors and manufacturers who
have to comply with CLP, as well as to insufficient protection of consumers, human health,
and the environment.
Incompliances with CLP of chemicals purchased from non-EU sellers are expected to be high
considering the available data from the enforcement reports indicated above on Article 48 of
CLP, which, however, do not specifically distinguish between intra-EU and imported
chemicals (see above). From an example given in ECHA’s enforcement report on REACH
restrictions, incompliances of goods coming from outside the EU are even higher and there is
no indication that for CLP such tendencies would be different176
. Based on estimations, 7.3
million incompliant products from outside the EU directly reached the EU consumer in
2021177
.
Regarding both problems 1 and 2, the findings of consultation activities show that all
stakeholders indicate problems arising in online sales of chemicals. In the open public
consultation, the overwhelming majority of respondents (93%, with agreement across all
stakeholder groups) believed that there is a great need to apply the same CLP obligations
(e.g., labelling, classification and notifications to poison centres) to hazardous chemicals
purchased online. In the targeted stakeholder survey, all groups of stakeholders ‘strongly
agreed’ or ‘agreed’ that the lower level of protection from hazards of chemicals sold online
hinders the ability of the CLP Regulation to reach its goals. Similarly, the interview
respondents indicated that non-compliance with classification and labelling as well as
Article 48 requirements of the CLP Regulation is a problem in online sales of chemicals. The
interviewees stressed that non-EU traders, especially small business entities engaged in e-
commerce, are common sources of the problem. CARACAL members and observers
acknowledged the problem of non-compliance of chemicals sold online with the CLP
Regulation in their written feedback to the meeting on this topic.
The problem driver of both problems is that CLP is not sufficiently equipped for keeping
pace with globalisation, technological development and new means of sale such as online
sales. According to OECD (2019), in 2015 there were, for example, over 2 million sellers
worldwide on Amazon marketplace, while the eBay online platform operated almost 30
international websites in 2018. E-commerce enables traders to introduce products that comply
175
Among the issues are difficulties in identifying responsible persons for compliance of the substance/mixture
sold online with the legislation, applying enforcement measures to companies located outside the EU,
identifying non-compliance cases in vast streams of online content, as these issues were reported by public
authorities (Kemi, 2021; Klar et al., 2020; Kemi, 2018; feedback by CARACAL members).
176
For example, of all incompliances found for non-compliant products containing lead, 60% of the online
marketplaces were not established in the EU. See ECHA enforcement report, Ref. 8, p. 30.
177
See baseline section below.
565
with the legal requirements of a non-EU country where they were manufactured to be sold to
global markets, where product safety and chemical legislation requirements may substantially
differ (Kemi, 2021). In EU28 countries many small and medium enterprises have been
actively engaging in e-commerce activities as an easy way to access new markets and expand
customer reach (OECD, 2019). The share of turnover from business-to-consumer web sales
in EU28 countries in 2017 was higher in small firms (43%) compared to 41% in large firms
and 34% in medium-sized ones. New business models, including variety of intermediary
services (e.g., social media, online marketplaces) that connect online sellers and buyers,
increase the engagement in e-commerce of even more diverse players worldwide (Kemi,
2021). The findings of a 2015 Eurobarometer survey (TNS Political & Social, 2015) show
that EU companies do not see the lack of knowledge as a major problem for getting engaged
in online sales. Not knowing the rules that a company must follow in online sales was not
perceived as a problem by 56% of respondents that sold online to other EU countries in the
past or at the time of the survey, while only 15% of them considered it a major problem.
As mentioned above, CLP does not apply to non-EU based economic actors, who can today
easily reach and sell directly to consumers in the EU and does not take into account that in
those situations consumers become de jure and de facto importers by buying online from
non-EU actors. Moreover, current CLP provisions do not, or do not exhaustively, address
online offers or advertisements, i.e. they do not impose an obligation to display labelling
information in online offers and they do not sufficiently clarify obligations for online
advertisements.
In the future, the two specific problems will be positively affected by horizontal draft and
already applicable legislation related to product safety, digital services and customs
legislation as well as by non-regulatory initiatives. Although this legislation will have a
positive impact on ensuring that consumers are better able to make informed choices upon
purchase and use of chemicals sold online, they will not entirely eliminate the problem, in
particular as the number of online sales is increasing (see figures in the baseline heading
below).
Baseline
Data underpinning the trend of increased online sales
Concerning the uptake of e-commerce services by consumers, an increased number of
consumer purchases are made online, therefore, chances rise that consumers will be affected
by non-compliant chemicals sold online. Data from the EU annual survey on the use of
Information and Communication Technologies (ICT) in households and by individuals show
that in 2020 and 2021178
around 8% of all individuals in the EU27 who have used the internet
in the three months prior to the survey bought cleaning products or personal hygiene products
online179
.
Online shopping behaviour of consumers was also explored by business entities. For instance,
in 2018, a research commissioned by Dynamic Parcel Distribution (DPD) to Kantar covered a
survey of 24,328 respondents from 21 European countries, while the survey performed by
178
These are the only years for which data are provided.
179
Eurostat database: Internet purchases – goods or services (2020 onwards)
[ISOC_EC_IBGS__custom_2139201]. This is the only product category reported in the survey which is subject
to CLP requirements. The statistics shows large differences between countries, with 24% of Dutch individuals in
2021 having purchased cleaning products or personal hygiene products online, against 1% of all individuals in
Bulgaria.
566
Ipsos for PayPal covered 34,000 customers in 31 countries. The findings of these researches
are in line with the data by Eurostat and also provide additional insight into consumer
behaviour:
According to PayPal research, 43% of shoppers in Western Europe and 44% in Eastern
Europe180
shop online domestically, while 9% and 10% are, respectively, engaged only in
cross-border shopping. Over 50% of Western and Eastern Europeans prefer large global
stores (e.g., Amazon or eBay) when purchasing from another country (PayPal & Ipsos,
2018).
According to Dynamic Parcel Distribution research, 19% of online shoppers in Europe
purchased goods from foreign websites. However, in some countries the number of online
shoppers buying from foreign countries is much higher, e.g., in Croatia – 29.6%, Ireland –
28.6%, Latvia – 27.9%, Portugal – 27.6%, and Slovenia – 27.5%. 13% of online shoppers in
Europe in 2018 purchased online at least once per week (DPD Group & Kantar, 2018).
Also the number of EU companies using e-commerce increases constantly, and web sales
through websites, online sales apps, and online marketplaces play an increasingly important
role. According to Eurostat, in the period 2010–2019, the number of enterprises with e-sales
increased from 15% in 2010 to 21% in 2019. The turnover of enterprises generated from e-
sales grew from 13% in 2010 to 20% in 2019. Fifteen percent (15%) of EU enterprises
conducted e-sales using only websites or apps, while 3% used only electronic data
interchange (EDI) for sales and another 3% used both.
Chemicals industry is increasingly engaged in trading via online marketplaces. The
evolution of chemical online marketplaces could be tracked back to 1996 with the
establishment of such platforms as EC Plaza in 1996. According to Accenture, early chemical
online marketplaces were mainly business-to-business services, while much later generalist
online marketplaces, such as Alibaba.com started to offer chemical products to consumers
(Elser & Radel, 2020181
). In its annual chemical marketplaces report, Chembid listed 61
online platforms. According to Chembid182
, chemical online marketplaces usually offer up to
10,000 products from up to 25,000 suppliers (Chembid, 2020183
).
The following trends could be retrieved from a study on cross-border online sales (Cross-
Border Commerce Europe, 2020)184
:
Growing revenues in cross-border online retail sales. The study observed a 14.4% increase in
e-commerce revenues compared to 2018 (excluding travel sector). In 2019 the cross-border
share was 23.55% of total online sales in Europe (EU16).
180
Russian Federation was also included in the group of Eastern European countries.
181
Elser, B. & Radel, T. (2020). Why digital marketplaces deserve a chance in chemicals. In Accenture
Chemicals and Natural Resources Blog. Available at: https://www.accenture.com/us-en/blogs/chemicals-and-
natural-resources-blog/elser-radel-digital-marketplaces-deserve-a-chance-in-chemicals
182
Chembid is an online metasearch engine and intelligence platform for chemical business that compiles a
yearly chemical marketplaces report that reviews and compares emerging online platforms.
183
Chembid (2020). The chemical marketplaces report 2021. Available at:
https://f.hubspotusercontent40.net/hubfs/6037596/chembids%20Chemical%20Marketplaces%20Report%20202
1.pdf
184
The analysis was based on the data from 16 countries from Western Europe and Scandinavia that put
limitations on the findings of this study in terms of generalising its result to the EU.
567
The market share of EU and non-EU players in online retail is almost equal: 55% is generated
by the EU traders and 45% by non-EU retailers. In 2019, the market share of the EU traders
increased by 3% compared to 2018.
Online marketplaces play a significant role in online sales. In cross-border trade within the
EU, 25 online marketplaces had a turnover of €10.5 billion in 2019 or 26.4% of total sales
and an increase of 17% compared to 2018. According to the study, online marketplaces grow
faster than the average market. In online trade by non-EU retailers, 80% of cross-border sales
are generated through online marketplaces, with Amazon as a leader with € 32 billion from
sales.
Estimations of incompliant chemicals related to the problems outlined above
Data on the CLP incompliances of online chemicals’ sales in and outside the EU that are
relevant for problem 1 and data on imports that are relevant for problem 2 is not available.
The figures below are established based on estimations which bring some uncertainty on the
place of origin of sellers (it must be assumed that in reality even more chemicals originate
from outside the EU although they are sold by domestic platforms), the overall chemicals’
incompliance rate compared to mere samples, the number of consumers exposed to
incompliant chemicals185
.
With respect to CLP non-compliant items from online sellers within the EU:
In 2021, 251 million consumers in the EU purchased goods online from sellers within the
EU. These consumers purchased 111 million items from categories of goods for which CLP
requirements are relevant for some of the goods.
Based on estimations, 16.6 million of the 111 million items purchased by these consumers
from sellers within the EU were not compliant with CLP requirements.
Based on estimations, in 2021, 9.6 million consumers purchased one CLP non-compliant
item from sellers within the EU and a further 3.5 million consumers purchased two CLP non-
compliant products from sellers within the EU – making a total of 16.6 million CLP non-
compliant items purchased from sellers within the EU.
With respect to CLP non-compliant items from sellers outside the EU:
In 2021 there were some 69.5 million consumers in the EU who purchased goods online from
sellers outside the EU. These consumers purchased 32.4 million items from categories of
goods for which CLP requirements are relevant for some of the goods.
Based also on estimations, 7.3 million of the 32.4 million items purchased by these
consumers from sellers outside the EU were not compliant with CLP requirements.
Following the same logic as before, in 2021, 4.2 million consumers purchased one CLP non-
compliant item from sellers outside the EU and a further 1.6 million consumers purchased
two CLP non-compliant products from sellers outside the EU – making a total of 7.3 million
CLP non-compliant items purchased from sellers outside the EU.
185
See detailed description of the methodology used in the Appendix.
568
The number of non-compliant items and consumers of those items is summarised in the table
below for all three scenarios (lower, central and upper).
Table 175: Number of non-compliant items and consumers of those items
Non-compliance
issue
Location of
seller
Number of
non-
compliant
items
purchased per
year (million)
Number of consumers
purchasing
one non-
compliant
item per year
(million)
two non-
compliant items
per year
(million)
Lower scenario
REACH
restriction non-
compliant items
within EU 42.5 24.5 9.0
outside EU 17.0 9.8 3.6
CLP non-
compliant items
within EU 11.1 6.4 2.3
outside EU 4.4 2.6 0.9
Central scenario
REACH
restriction non-
compliant items
within EU 70.8 40.9 14.9
outside EU 31.0 17.8 6.6
CLP non-
compliant items
within EU 16.6 9.6 3.5
outside EU 7.3 4.2 1.6
Upper scenario
REACH
restriction non-
compliant items
within EU 110.0 63.6 23.2
outside EU 64.3 36.9 13.7
CLP non-
compliant items
within EU 33.3 19.2 7.0
outside EU 19.5 11.2 4.1
Short description of draft and already applicable EU legislation relevant for solving the
problems
Taking into account the dynamic baseline, here is a short description of the horizontal draft
and already applicable legislation to be considered: the draft Digital Services Act186
, the draft
General Product Safety Regulation187
, the already applicable Market Surveillance
Regulation188
, the Consumer Rights Directive189
and customs legislation190
.
186
Proposal for a Regulation of the European Parliament and of the Council on a Single Market For Digital
Services (Digital Services Act) and amending Directive 2000/31/EC, COM(2020) 825 final.
187
Proposal for a Regulation of the European Parliament and of the Council on general product safety,
amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council, and repealing Council
Directive 87/357/EEC and Directive 2001/95/EC of the European Parliament and of the Council, COM(2021)
346 final.
188
Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market
surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No
765/2008 and (EU) No 305/2011, OJ L 169, p. 1.
189
Directive 2011/83/EU on consumer rights, OJ L 304, p.64.
190
Regulation (EU) No 952/2013 laying down the Union Customs Code (“UCC”), OJ L 269 10.10.2013, p. 1;
amendments made in 2019 and 2020 to the UCC Delegated Regulation (EU) 2015/2446 of 28 July 2015
supplementing Regulation (EU) No 952/2013 of the European Parliament and of the Council as regards detailed
rules concerning certain provisions of the Union Customs, OJ L 343 29.12.2015, p. 1; Implementing Regulation
569
Customs legislation – relevant for problem 2
Given that in problem 2 consumers are exposed to chemicals with no or incorrect
classification, labelling and packaging when buying from non-EU actors shipping
chemicals directly into the EU, who do not have to comply with CLP, customs legislation
becomes relevant as, before reaching consumers, those chemicals have to pass through
customs and be released for free circulation. Before goods are released for free circulation in
the EU, a customs declaration needs to be submitted by the importer or its representative
according to the Union Customs Code191
. The importer under customs legislation can be a
consumer or other natural or legal person, depending on the applicable rules for low value
consignments, other consignments, etc.192
. So, when the consumer is the importer under
customs legislation, chemicals pass through customs, are released for free circulation and
directly reach the “natural person responsible for import” in the EU, i.e. the consumer.
The dynamic baseline takes into account:
The recently adopted VAT e-commerce package that introduced a financial liability for the
online platforms which facilitate the sale of low value goods dispatched from a third country
to consumers in the EU for the collection of VAT on those sales, applicable as of 1 July 2021.
Draft General Product Safety Regulation (GPSR)/Market Surveillance Regulation
(MSR) – both relevant for problems 1 and 2
Considerations relevant to solve problem 2
In order to ensure that chemicals sold on-line by non-EU actors are properly labelled and
packaged (following proper classification), one option would be to introduce the obligation to
have a responsible economic actor in the EU by default, so that an economic actor in the EU,
who should always ensure compliance with CLP requirements before chemicals reach
consumer, is inserted in the supply chain. Draft GPSR and MSR already contain similar
provisions which however do not cover CLP and would hence not solve the problem.
MSR provides for the need to have a person responsible for compliance by default in the EU
for listed pieces of legislation, but does not include CLP in that list193
. Draft GPSR
(EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of
Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs
Code, OJ L 343 29.12.2015, p. 558.
191
Article 127, Article 158 of the UCC.
192
For low value consignments of goods with a value not exceeding EUR 22, new VAT and customs e-
commerce rules are applicable for their import as of 1 July 2021 to ensure fair competition for EU businesses
and reduce the VAT losses resulting from the importation of low value consignments from third countries. The
VAT exemption for imported goods below EUR 22 is abolished and an import declaration will be required for
all goods entering the EU, regardless of their value.
Further, the UCC Delegated Regulation (EU) 2015/2446 of 28 July 2015 was modified in 2019 and 2020 to
adapt to a new form of customs declaration for release for free circulation of goods in consignments not
exceeding EUR 150 (super-reduced dataset) to facilitate and speed up the process of dealing with a high volume
of parcels. This customs declaration is available to any person (consumers, business, postal or express
operators).
According to the guidance on “Importation and Exportation of low value consignments – VAT E-Commerce
Package” the customs’ importer could be a private or legal person who declared for itself or uses a
representative who may act in the name and on behalf of the person represented (direct representation) or in
his/her own name and on behalf of the person represented (indirect representation).
193
See Article 4(5) of CLP MSR.
570
establishes the principle of having a responsible person to ensure product safety and extends
it to all products194
. However, that particular provision is not applicable to CLP, since it
excludes Union harmonisation legislation - including CLP - from its scope195
. A change of
MSR to extend the responsible person for compliance by default to CLP would be quite
complicated since the definitions in both legislations of actors (importers, distributors etc.)
and of placing on the market are different and do not match exactly.
To sum up, CLP is not covered by either MSR or draft GPSR in relation to having a person
responsible for compliance in the EU by default (other than the consumer). Therefore, it
would be for CLP itself to address the problem of ensuring chemicals sold from outside the
EU are safe by means of another economic actor in the EU who would bear compliance
obligations. Consequently, such action would not be part of the dynamic baseline.
Considerations relevant to solve problem 1 on online offering
In contrast to problem 2, Chapter III, Section 2 and Chapter IV of draft GPSR (Online
marketplaces) apply to CLP and help consumers to make informed choices when they
purchase chemicals online (problem 1). Rules are provided for economic operators to indicate
product safety information in online offers196
as well as for online marketplaces to design and
organise their online interface in a way that enables traders to provide useful information197
.
194
Chapter III, Section 1 of draft GPSR provides for the obligations of economic operators and sets forth the
need of having a person responsible for compliance in the EU (Article 15, Responsible person for products
placed on the Union market) by default.
195
Following Article 2(1) of the draft GPSR, Union harmonisation legislation as listed under Annex I of MSR –
that includes CLP – is excluded from the applicability of Chapter III, Section 1 of draft GPSR, see draft GPSR,
Article 2 (Scope):
1. This Regulation shall apply to products defined in Article 3(1), placed or made available on the market in so
far as there are no specific provisions with the same objective in rules of Union law which regulate the safety of
the products concerned. Where products are subject to specific safety requirements imposed by Union
legislation, this Regulation shall apply only to the aspects and risks or categories of risks not covered by those
requirements. In particular, as regards products subject to specific requirements imposed by Union
harmonisation legislation as defined in Article 3(25),
(a) Chapter II shall not apply insofar as the risks or categories of risks covered by Union harmonisation
legislation are concerned;
(b) Chapter III, Section 1, Chapters V and VII, Chapters IX to XI shall not apply.
196
Chapter III, Section 2, Article 18 of draft GPSR, which isapplicable to CLP states that “where products are
made available on the market online or through other means of distance sales by the relevant economic
operators, the relevant offer of the product shall clearly and visibly indicate at least the following information:
[…] (d) any warning or safety information that is to be affixed on the product or to accompany it in accordance
with this Regulation or the applicable Union harmonisation legislation in a language which can be easily
understood by consumers”.
197
Chapter III (rules for online marketplaces) Art. 20(5) draft GPSR: For the purpose of the requirements of
Article 22(7) of Regulation (EU) […/…] on a Single Market for Digital Services (Digital Services Act) and
amending Directive 2000/31/EC, online marketplaces shall design and organise their online interface in a way
that enables traders to provide the following information for each product offered and ensures that it is displayed
or otherwise made easily accessible by consumers on the product listing:
(a) name, registered trade name or registered trade mark of the manufacturer, as well as the postal or electronic
address at which they can be contacted;
(b) where the manufacturer is not established in the Union, the name, address, telephone number and electronic
address of the responsible person within the meaning of Article 15 (1);
(c) information to identify the product, including its type and, when available, batch or serial number and any
other product identifier;
571
Those obligations, applicable to economic actors and online marketplaces, will be taken into
account as a baseline scenario for the CLP revision. This impact assessment will examine
whether CLP requires a specific reference to the applicable provisions to enhance compliance
and for coherence between the different legislations.
Draft DSA (relevant for problems 1 and 2) and E-Commerce Directive198, Consumer
Rights Directive (relevant for problem 1)
Considerations relevant to solve problem 1
Draft DSA, the E-Commerce Directive and the Consumer Rights Directive contain provisions
on online advertisement and offers that help solving problem 1 and ensuring correct
communication of hazards to consumers.
Draft DSA provides for obligations of online platforms to trace their traders when they
promote messages or offer products to consumers (see Article 22 draft DSA). Further, it
contains a provision on online advertising transparency (Article 24). Draft DSA also defines
“advertisement” as “information designed to promote the message of a legal or natural
person, irrespective of whether to achieve commercial or non-commercial purposes, and
displayed by an online platform on its online interface against remuneration specifically for
promoting that information”199
. This definition should also be used under CLP to cover
online advertisements and to clearly distinguish advertisement from offers.
The E-Commerce Directive provides for rules that (advertising) information to be provided
for commercial communications must follow (Article 6), to clearly identify its commercial
content200
.
Further, also the Consumer Rights Directive contains rules on information requirements for
distance and off-premises contracts, including online sales, which also apply to CLP201
.
CLP should take into account all those applicable rules and this assessment should examine
the need of making cross-references to those pieces of legislation and providing that any rules
under CLP are without prejudice to these provisions of the other pieces of legislation (this
would also include an update of the reference to Directive 97/7/EC on the protection of
consumers in respect of distance contracts under Article 48 which was repealed by the
Consumer Rights Directive).
Hence, those provisions are part of the dynamic baseline.
Considerations relevant to solve problem 2
(d) any warning or safety information that is to be affixed on the product or to accompany it in accordance with
this Regulation or the applicable Union harmonisation legislation in a language which can be easily understood
by consumers.
198
Directive 2000/31/EC, OJ L 178/1.
199
Article 2(n) draft DSA.
200
The E-Commerce Directive provides that national governments must ensure that advertising follows certain
rules: - it is clearly identifiable as advertising; - the person or company responsible for it is clearly identifiable; -
promotional offers, games or competitions are clearly identifiable, and the conditions are easily accessible and
presented in clear and simple terms.
201
See Article 6 of the Consumer Rights Directive.
572
Pursuant to Chapter II of the draft DSA (Liability of providers of intermediary services), the
liability of intermediary services, such as online platforms202
, is conditional. For instance,
they can only be held liable for the illegal content on their websites if they were made aware
of such illegal content and they did not remove it. Also, under Article 15 of the E-Commerce
Directive, Member States are not allowed to introduce a general obligation of intermediary
service providers to monitor the information they store or transmit for non-compliance with
legal requirements.
CLP does not provide for any specific obligations of online platforms regardless if they are
established in or outside the EU. Those platforms would only have obligations under CLP if
they met the definitions of the CLP actors, i.e. importers, manufacturers, distributors
(including retailers), downstream users and this is very unlikely. Thus, if a non-EU actor sells
directly to an EU consumer even via a platform established in the EU, that platform would
neither have an obligation under CLP to comply with it (while the non-EU sellers themselves
would also have no such obligation), nor any liability under the draft DSA or the E-
Commerce Directive. Hence, the problem of supplying unsafe chemicals from outside the
EU to consumers persists.
This impact assessment takes into account the general liability exemption under draft
DSA and the E-commerce Directive and will not deviate from that general principle.
Therefore, the option to have a responsible actor in the EU by default and include online
platforms as such an actor will be discarded (see below).
Other initiatives
The baseline also takes into account already existing measures at EU level to ensure
compliance of online sales, such as:
Product Safety Pledge: This voluntary initiative was issued by the European Commission in
2017 and signed by large online marketplaces. It includes voluntary commitments to consult
the Product Safety Gate (former RAPEX) for information on recalled/dangerous products,
react within two working days on government notices about unsafe products and cooperate
with EU Member State authorities in identifying dangerous products203
.
The platforms committed to collaborate with public authorities and contribute to
identifying and removing non-compliant products. Key performance indicators to
monitor the implementation of commitments were developed and are reported by
online platforms (Table 175).
Table 176: Examples of performance data of online marketplaces under the Product Safety Pledge
Key performance indicator 1: product listings removed based on governmental notices
Reporting period Online platforms
No. of governmental
notices
No. of removed
product listings
1 December 2020 to
31 May 2021
AliExpress, Allegro, Amazon,
CDiscount, eBay, Rakuten France,
Wish, eMag and bol.com
2,732 13,555
1 June 2020 to 30 AliExpress, Amazon, eBay, Rakuten 2,033 12,267
202
See Article 2(f) of draft DSA which defines the different intermediary services and further distinguishes
between “mere conduit”, “caching” and “hosting”. “Online platforms” are hosting service providers.
203
Online marketplaces participating are: Joom, Etsy, bol.com eMAG Wish.com, AliExpress, Amazon, eBay,
Rakuten France, Allegro and Cdiscount.
573
Table 176: Examples of performance data of online marketplaces under the Product Safety Pledge
November 2020 France, Allegro and CDiscount
Key performance indicator 2: product listings removed based on the monitoring of recall websites
Reporting period Online platforms
No. of detected
alerts
No. of removed
product listings
1 December 2020 to
31 May 2021
AliExpress, Allegro, Amazon,
CDiscount, eBay, Rakuten France,
Wish, eMag and bol.com
885 27,717
1 June 2020 to 30
November 2020
AliExpress, Amazon, eBay, Rakuten
France, Allegro and CDiscount
1,760 70,273
Sources: Progress reports on the implementation of the product safety pledge. 2021 report available at:
https://ec.europa.eu/info/sites/default/files/5th_progress_report_product_safety_pledge.pdf
2019 report available at: https://ec.europa.eu/info/sites/default/files/4th_progress_report_product_safety_pledge_-
_final_0.pdf
However, the performance data of online marketplaces show that safety pledge
commitments could hardly provide any substantial contribution to solving the
problem of non-compliance of chemicals with the CLP Regulation. The performance
data refers to all product safety non-compliances with different pieces of legislation.
To compare, in 2015-2019 Member States performed 288,280 controls of compliance
with the CLP Regulation and identified 68,898 cases of non-compliance (Milieu
Consulting, 2020).
EU Product Compliance Network (EUPCN): This network aims to structure the coordination
and cooperation between market surveillance authorities in EU countries, and streamline
market surveillance practices within the EU that facilitate the implementation of joint
enforcement activities by member state authorities, such as joint investigations. Amongst the
initiatives or activities listed by the EUPCN’s work programme 2021-2022 is the introduction
of a web crawler, i.e. a computer programme that automatically searches information on the
web and can hence be used to identify information on incompliant products. It is highly
unlikely that such an initiative would solve the problem of non-compliance of chemicals with
the CLP Regulation, due to its broad scope.
DESCRIPTION OF POLICY MEASURES
To solve problem 1, the following policy measures were identified:
#17: Amend or update CLP to refer to horizontal provisions on online offering
and advertisement (e.g. draft GPSR, draft DSA, E-Commerce Directive and
Consumer Rights Directive)
This would entail either an amendment of Article 48 (Advertisement) of the CLP when
it comes to referring to the horizontal provisions on advertisement or mentioning those
horizontal provisions in a recital with regards to distance contracts.
Article 48 could also be revised to lay out the same requirements for substances and
mixtures to be provided when advertising (currently they are different, provided under
par. 1 and 2 respectively) as suggested by stakeholders in the different consultations204
.
204
For substances any advertisement shall mention the hazard class and categories and for mixtures the type or
types of hazard indicated on the label if a member of the general public concludes a contract before having first
sight of the label. See Article 48 CLP.
574
This would also entail addressing online offers in CLP, for instance by adding an
article that the rules in the draft GPSR, and in particular rules imposing obligations on
economic operators to display product safety information (Article 18 draft GPSR) and
on online marketplaces to allow traders to provide that information (Article 22 draft
GPSR), need to be adhered to (e.g. add Article 48a on online offers).
#22: Periodically run consumer awareness raising campaigns on chemicals
offered and advertised online
This would entail running campaigns at Union wide level making consumers aware
that they need to pay particular attention when buying chemicals online and they could
be organised by ECHA. This measure is aimed at reaching out to consumers with the
purpose of providing information about hazard identification and communication
requirements for products sold online. To be effective such measures use various
communication media and provide information in an attractive and simple way205
.
To solve problem 2, the following policy measures were identified:
#18: Introduce the obligation to have a responsible economic actor in the EU by
default under CLP
This would entail a change of the CLP in order to introduce the obligation of always
having a responsible economic actor for CLP compliance in the EU. Such actor
should carry out a commercial activity (and therefore would not include the
consumer), and could be a natural or legal person. Except for the case outlined above
under problem 2, where the consumer buys directly from a seller outside the EU and
there is no economic actor in the EU involved in commercial activity, in all other
cases (of imports) such an economic actor is already established in the EU.
DM 13: Introduce the obligation to have a responsible economic actor in the EU
and include online platforms as such responsible actors
This would entail the same change under CLP as measure 1, with the difference that
online platforms established in the EU would be explicitly qualified as responsible
economic actors for compliance in case non-EU actors sell chemicals to EU via online
means.
Taking into account the general liability exemption of online platforms under draft
DSA and E-Commerce Directive, this measure is discarded.
Below a table outlining the different policy measures:
Table 177: Policy measures
Specific objective Policy measure Regulatory
or non -
regulatory?
Alternative
option?
Preference?
Retained
or
discarded?
Why
retained or
discarded?
1 Ensure comprehensive
communication for online
offers/advertising
#17 Amend or update
CLP to cross-refer to
horizontal provisions
regulatory #22 - PO. Retained
205
Similar measures are discussed in OECD (2016) and EC (2015).
575
on online offering and
advertisement (e.g.
draft GPSR,
Consumer Rights
Directive)
#22 Raise consumer awareness
campaigns on chemicals offered
and advertised online
non-
regulatory
#22 Retained
2 Ensure products sold on-
line by non-EU economic
actors reaching directly EU
consumers are properly
labelled and packaged
(following proper
classification)
#18 Introduce the
obligation to have a
responsible economic
actor in the EU by
default under CLP
regulatory #18 - PO Retained
#DM13 Introduce
obligation to have a
responsible economic
actor in the EU and
make online platforms
such responsible
actors
regulatory #18 Discarded Not in line
with draft
DSA and E-
Commerce
Directive
Description of impacts
Social and health impacts
The social and health benefits of the measures are associated with both a reduction in the
number of CLP and REACH non-compliant products purchased online and a consequent
reduction in the exposure of individuals and the environment to potential hazards.
#22 and #17 relating to consumer awareness and CLP cross-referencing reduce non-
compliance for both intra-EU and import sales. The table below provides the central estimate
of the impact of these two options on reducing the sale of non-CLP compliant items and
products that are CLP relevant and are also non-compliant with REACH restrictions.
Table 178: PO8: Reduction in number of non-compliant items and exposed consumers per year for CLP
referencing and consumer awareness measures based on 2021 figures*
Number of items
purchased per year
(number)
Number of consumers purchasing
one item per year
(number)
two items per year
(number)
#17 CLP cross-referencing
REACH
restriction non-
compliant items
Within EU 1 109 816 (1.6%) 641 456 (1.6%) 234 180 (1.6%)
Imports 243,306 (0.8%) 139,619 (0.8%) 51,843 (0.8%)
CLP non-
compliant items
Within EU 3,329,449 (20%) 1,924,369 (20%) 702,540 (20%)
Imports 729,918 (10%) 418,858 (10%) 155,530 (10%)
REACH
restriction non-
compliant items
Total 1,353,122 (1.3%) 781,075 (1.3%) 286,023 (1.3%)
CLP non-
compliant items
Total 4,059,367 (17%) 2,343,227 (17%) 858,070 (16.9%)
#22 Consumer awareness
REACH Within EU 554,908 (0.8%) 320,728 (0.8%) 117,090 (0.8%)
576
restriction non-
compliant items
Imports 243,306 (0.8%) 139,619 (0.8%) 51,843 (0.8%)
CLP non-
compliant items
Within EU 1,664,725 (10%) 962,184 (10%) 351,270 (10%)
Imports 729,918 (10%) 418,858 (10%) 155,530 (10%)
REACH
restriction non-
compliant items
Total 798,214 (0.8%) 460,347 (0.8%) 168,933 (0.8%)
CLP non-
compliant items
Total 2,394,643 (10%) 1,381,042 (10%) 506,800 (10%)
* Values are calculated based on sales of online goods in 2021. There was 1.1% growth in online sales between 2020
and 2021. Thus, the annual values in this table could be expected to increase over time.
The responsible economic actor obligation (measure #18) affects only import sales (and not
online purchases from sellers within the EU). The table below provides the central estimate
of the impact of the responsible economic actor obligation on options on reducing the sale of
non-CLP compliant items and products that are CLP relevant and are also non-compliant
with REACH restrictions. Estimates of the reduction in the number of consumers exposed to
non-compliant products are also provided.
577
Table 179: PO8: Reduction in number of non-compliant imported items and exposed consumers per year for
the responsible economic actor measure based on 2021 figures*
Number of items
purchased per
year (number)
Number of consumers
purchasing
one item per
year
(number)
two items per
year (number)
#18 Responsible economic actor obligation
Import of REACH restriction
non-compliant items
811,020 (0.8%)
465,398
(0.8%)
172,811 (0.8%)
Import of CLP non-compliant
items
2,433,059 (10.2%)
1,396,194
(10.1%)
518,433 (10.2%)
* Values are calculated based on sales of online goods in 2021. There was 1.1% growth in online sales
between 2020 and 2021. Thus, the annual values in this table could be expected to increase over time.
Environmental impacts
It was not possible to assess environmental impacts quantitatively. However, from a
qualitative point of view, positive environmental impacts are expected from all sub-measures,
albeit with different magnitudes in terms of their effectiveness. It is plausible that especially
the expected reduction in imports of non-CLP compliant products will have a quite
substantial positive impact. The more incompliant chemicals purchased and used are reduced,
the better for the environment, because this implies less spillage, fewer emissions, less
pollution from wrongly classified substances.
Economic impacts
#17 CLP cross-referencing: The option would not require a change to the physical label or
the packaging to which it is attached. Rather, information from the label would need to be
included in future online adverts/offerings and this might, for example, be achieved simply
by including a photograph of the label/information in the series of photos already provided on
most online adverts/offerings or by copying and pasting the information into the item
description. Such actions are unlikely to have any perceptible impact on the costs.
Regardless, such costs would need to be borne already by online traders and platforms in
order to comply with draft GPSR (see above). This sub-measure would just better link the
CLP obligations with the ones under draft GPSR to ensure coherence and clarity. Costs for
enforcement authorities would already be alleviated by the draft GPSR because they would
be better able to check compliance.
#22 Consumer awareness raising campaigns: The costs of the measure are associated with
the operation of a consumer awareness campaign. This could be included within existing
campaigns (such as the European Interactive Digital Advertising Alliance) or could be
standalone. As the intended target of such a campaign would be online consumers, operation
of a digital campaign would be the method of choice, making it relatively inexpensive to
operate. Assuming €150,000 in staff costs (3 FTEs) and €150,000 for equipment and
operational costs would imply costs of around €300,000 per year.
#18 Responsible economic actor obligation: Sellers based in the EU would not incur any
costs, but sellers based outside the EU would have to sell via a new or already established EU
based responsible economic actor and are likely to have to pay a commission to that
578
responsible actor. These same costs (to outside sellers) would bring benefits to the existing or
newly established responsible economic actors in the EU. With 7.3 million items at a value of
€20 each (consistent with the €22 VAT free cut-off that applied until July 2021) and a
commission of 2%, this equates to an EU benefit of around €2.9 million per year for items
that are non-compliant at present. A commission of 5% would equate to benefits to the EU of
around €7.3 million per year. As requirements would also apply to products that currently
comply with CLP (as well as those that don’t), such values should be regarded as minimum
and conservative estimates.
Moreover, sellers from outside the EU would have to bear the compliance cost of adhering to
the CLP rules and this would level the playing field between sellers from in and outside the
EU, with sellers from inside the EU benefitting from the resulting fairness in competition. It
was impossible to quantitatively assess how much it costs to comply with CLP rules or how
much the EU-based sellers would gain from enhanced competitiveness.
COMPARISON OF IMPACTS AND PREFERRED OPTION
CLP cross-referencing (#17) does not imply any additional economic costs for both online
traders/platforms and market surveillance authorities. Those costs would be inexistent due to
the measures in draft GPSR. Societal and environmental impacts of the measure are positive
as they would grant certainty to consumers regarding various aspects of online sales (from
advertisement to offers) and thus allow consumers to be better informed. Consumer
awareness raising campaigns (#22) are not so costly either, but they would have a lesser
positive societal and environmental impact than #17. The responsible economic actor
obligation (#18) has no negative economic impacts for EU actors. To the contrary, (i) it levels
the playing field between EU and non-EU actors and (ii) brings new job opportunities to the
EU. Sub-measure 2.1. also has positive environmental and social impacts since it reduces the
number of incompliant products circulating in the market, leading to consumers being less
exposed to incompliant products and to less spillage or pollution from wrongly classified
chemicals in the environment.
The preferred options are measures #17 (CLP cross-referencing) and measure #18 (introduce
a responsible economic actor obligation).
APPENDIX
The evolution of the problem of non-compliance of chemicals sold online with the CLP
Regulation over time will be shaped by the development in e-commerce and regulatory and
non-regulatory initiatives that have been already undertaken by the Commission.
No specific data are collected on the actual number of online sales, the location of sellers or
the products sold. However, Eurostat does produce an e-commerce dataset that describes the
percentage of (all individuals) across the EU that have made purchases in the preceding 3
months. These data are organised into different data areas including:
Percentage of individuals that have purchased items within the last three months from
sellers within their nation, from another EU Member State, from sellers in the rest of
the world (RoW) or where country is not known;206
206
https://ec.europa.eu/eurostat/databrowser/view/isoc_ec_ibos/default/table?lang=en
579
Percentage of individuals making 1-2, 3-5, 6-10 or more than 10 online purchases in a
three-month period;207
Percentage of individuals making purchases of different value categories in the three-
month period; and
Percentage of individuals that have purchased each of 16 different types of physical goods
and 13 different types of services.208
The organisation and presentation of some of these sets (notably identity of items purchased)
is different and more expansive/explicit for the years 2020 and 2021 compared with the
preceding years.
Total number of online purchases/transactions
Whilst, as noted, no specific data on the volume of sales are available, using the Eurostat data
it is possible to develop best estimates of the number of items sold online by multiplying the
relevant percentages of (all individuals) by the total number of individuals (i.e. the
population). Table 179 provides the total number of online purchases/transactions over three
months (all types of purchase) implied by the data. The table provides data for the full suite
of categories of online purchases, including those that are not CLP (or REACH) relevant.
This is to allow the total numbers of purchases derived by consideration of Eurostat data on
individual product categories (in Table 179) to be compared with total numbers of purchases
derived from other statistical breakdowns produced by Eurostat (such as numbers of
purchases made). In this way, the comparison provides a means to assess the consistency and
reasonableness of the estimates of items purchased (including CLP relevant products).
207
Eurostat, Internet purchases by individuals (2020 onwards), available at:
https://ec.europa.eu/eurostat/databrowser/view/isoc_ec_ib20/default/table?lang=en
208
https://ec.europa.eu/eurostat/databrowser/view/isoc_ec_ibgs/default/table?lang=en
580
Table 180: Implied total number of online purchases/transactions over three months (all types of purchase)
Percentage of
individuals
making online
purchases within
a three-month
period
Implied number of
purchases/transactions
within a three-month period
2020 2021 2020 2021
Clothes (including sport clothing),
shoes or accessories
33% 38% 147,615,572 170,314,137
Sports goods (excluding sport
clothing)
11% 13% 49,205,191 58,265,363
Children toys or childcare items 9% 11% 40,258,792 49,301,461
Furniture, home accessories or
gardening products
15% 16% 67,097,987 71,711,216
Music as CDs, vinyls etc. 4% 3% 17,892,797 13,445,853
Films or series as DVDs, Blu-ray etc. 4% 3% 17,892,797 13,445,853
Printed books, magazines or
newspapers
14% 14% 62,624,788 62,747,314
Computers, tablets, mobile phones or
accessories
14% 13% 62,624,788 58,265,363
Consumer electronics or household
appliances
10% 10% 44,731,992 44,819,510
Medicine or dietary supplements such
as vitamins (online renewal of
prescriptions is not included)
12% 11% 53,678,390 49,301,461
Deliveries from restaurants, fast-food
chains, catering services
15% 17% 67,097,987 76,193,166
Food or beverages from stores or from
meal-kits providers
10% 10% 44,731,992 44,819,510
Cosmetics, beauty or wellness
products
14% 15% 62,624,788 67,229,265
Cleaning products or personal hygiene
products
8% 8% 35,785,593 35,855,608
Bicycles, mopeds, cars, or other
vehicles or their spare parts
5% 5% 22,365,996 22,409,755
Other physical goods 10% 11% 44,731,992 49,301,461
Online purchases (3 months) from
private persons: any physical goods
18% 18% 80,517,585 80,675,117
Music as a streaming service or
downloads
13% 14% 58,151,589 62,747,314
Films or series as a streaming service
or downloads
17% 17% 76,044,386 76,193,166
e-books, online-magazines or online-
newspapers
7% 7% 31,312,394 31,373,657
Games online or as downloads for
smartphones, tablets, computers or
consoles
9% 9% 40,258,792 40,337,559
Computer or other software as 9% 9% 40,258,792 40,337,559
581
Table 180: Implied total number of online purchases/transactions over three months (all types of purchase)
Percentage of
individuals
making online
purchases within
a three-month
period
Implied number of
purchases/transactions
within a three-month period
downloads including upgrades
Apps related to health or fitness
(excluding free apps)
4% 4% 17,892,797 17,927,804
Other apps (e.g. related to learning
languages, travelling, weather)
(excluding free apps)
4% 4% 17,892,797 17,927,804
Tickets to sport events 3% 1% 13,419,597 4,481,951
Tickets to cultural or other events 12% 5% 53,678,390 22,409,755
Subscriptions to the internet or mobile
phone connections
8% 7% 35,785,593 31,373,657
Subscription to electricity, water or
heating supply, waste disposal or
similar services
6% 5% 26,839,195 22,409,755
Household services (e.g. cleaning,
babysitting, repair work, gardening)
2% 2% 8,946,398 8,963,902
Total 1,261,442,16
3
1,263,910,17
3
Notes: Based on combination of EUROSTAT population data
(https://ec.europa.eu/eurostat/databrowser/view/demo_pjan/default/table?lang=en) of 447 319 916 for 2020 and
448 195 097 for 2021 and E-Commerce and digital economy and society data
(https://ec.europa.eu/eurostat/databrowser/view/isoc_ec_ibgs/default/table?lang=en)
Clearly, the values in Table 179 are derived from the number of individuals who have
purchased at least one of each of the listed items in the three-month period. As many
consumers may have made more than one purchase in that period, the numbers of items as
calculated in Table 179 may represent a minimum. However, Eurostat also provide data on
the percentage of (all) individuals making:
1 to 2 (average 1.5) online purchases within three months;
3 to 5 (average 4) online purchases within three months;
6 to 10 (average 8) online purchases within three months; and
More than 10 online purchases within three months.209
Applying these percentages to the number of individuals and number of purchases provides a
second estimate of the total number of purchases/transactions in a three-month period for
comparison with the total numbers of purchases of 1.264 billion (2021) and 1.261 billion
(2020) from Table 179. For three of the four frequency categories the number of purchases is
established. However, for the category of ‘more than 10 purchases’, the number is not
defined but can be varied in the calculations to adjust the returned number of transactions
from the frequency data until it matches the totals given in Table 179. Cross-checking the
209
Eurostat, Internet purchases by individuals (2020 onwards), available at:
https://ec.europa.eu/eurostat/databrowser/view/isoc_ec_ib20/default/table?lang=en
582
numbers in this way suggests that the ‘more than 10’ category would have to equate to an
average of around 14 purchases in three months for the two sets of numbers to agree. This, in
turn, equates to a weighted average of 2.8 purchases per individual across all individuals
making purchases within the three-month period.
As, from the cross-checking, this does not seem unreasonable it is assumed that the
calculation total number of purchases/transactions across all categories of purchases in Table
179 is relatively unaffected by the possibility that multiple individuals may have made
multiple purchases from the same category of product. Applying a ‘common sense’
approach, for multiple purchases from the same individuals to significantly affect the data
and the estimate of the total number of purchases/transactions, multiple individuals would
have to be making multiple purchases of the same category of item. Whilst this is possible,
the numbers in Table 179 represent the best available estimate of online
purchases/transactions, and it is assumed that the estimates in relation to the CLP (and
REACH) relevant categories are a reasonable reflection of the reality.
Online purchases from sellers outside the EU
Eurostat also produce data describing the percentage of (all) individuals who have made an
online purchase from sellers in their own nation or in different country categories.210
The
data for 2020 and 2021 are provided in Table 180. These data can be used to describe both
the percentage of (all) individuals making purchases from EU versus non-EU sellers and also
the fraction of items sold by EU versus non EU sellers. Concerning the implied origin of
products, this is only an assumption one can make given that online platforms in one Member
State may very well sell goods not originating from that Member State but from a third
country. So, in reality, the number of products originating from third countries might be
much higher.
Table 181: Purchases made from sellers in different locations
Percentage of
individuals making
purchases (from
EUROSTAT)
Fraction of items
from sellers in
different locations
types*
2020 2021 2020 2021
Online purchases: from national sellers
over three months
47% 47% 59% 56%
Online purchases: from sellers from other
EU countries over three months
17% 18% 21% 21%
Online purchases: from sellers from the
rest of the world (non-EU) over three
months
12% 12% 15% 14%
Online purchases: from sellers with
unknown country of origin over three
months
4% 7% 5% 8%
Notes: * These percentages are calculated from the percentage of individuals data
Source: Eurostat data https://ec.europa.eu/eurostat/databrowser/view/isoc_ec_ibos/default/table?lang=en
Number of individuals ‘exposed’
210
https://ec.europa.eu/eurostat/databrowser/view/isoc_ec_ibos/default/table?lang=en
583
From Table 180, at least211
12% of (all) individuals made a purchase from the RoW in 2020
and 12% in 2021. By the same token, at least 4% of (all) individuals made a purchase from an
unknown country in 2020 and 7% in 2021. Some individuals in the statistics may have made
purchases from both a country in the RoW and an unknown country and some individuals
may have only made purchases from either the RoW or from an unknown country. Thus, the
total percentage of (all) individuals making purchases from the RoW or an unknown country
for 2021 ranges between 12% (based on all individuals making in one or both so the
maximum of the two categories applies) and 19% (based on all individuals making either
purchases from RoW or from an unknown country so the total applies = 12% + 7%).
Applying the percentages and approaches to the number of individuals provides the total
number of individuals in the EU making purchases from sellers within and outside the EU in
Table 181. Whilst the numbers in the table are derived from three-month statistics, for the
purpose of the IA it will be assumed that they represent the total number of people making
purchases annually. This would be to assume that the individuals making purchases in each
of the four three-month blocks are the same individuals, a fair assumption given that
assuming that they are all different would produce annual numbers larger than the EU
population.
Thus, the numbers in Table 181 provide the total EU population purchasing goods coming
from territories outside the EU in 2020 and 2021. A proportion of these consumers will be
exposed to inaccurate and/or incomplete information in advertisements/offers and/or
exposure to substances that are restricted in the EU.
Table 182: Number of individuals making online purchases from within and outside the EU
2020 2021
Online purchase from outside the EU
Online purchases: from sellers from the rest of the world (non-EU) 53,678,390 53,783,412
Online purchases: from sellers with unknown country of origin 17,892,797 31,373,657
Total assuming different people between two categories 71,571,187 85,157,068
Total assuming same people some of whom also make purchases from both
categories
53,678,390 53,783,412
Total individuals making extra EU purchases (assuming average of the
two cases above)
62,624,788 69,470,240
Online purchases from within the EU
Online purchases: from national sellers 210,240,361 210,651,696
Online purchases: from sellers from other EU countries 76,044,386 80,675,117
Total assuming different people between two categories 286,284,746 291,326,813
Total assuming same people some of whom also make purchases from both
categories
210,240,361 210,651,696
Total individuals making EU purchases (assuming average of the two
cases above)
248,262,553 250,989,254
Source: Based on combination of EUROSTAT population data
(https://ec.europa.eu/eurostat/databrowser/view/demo_pjan/default/table?lang=en) and E-Commerce and digital
economy and society data
https://ec.europa.eu/eurostat/databrowser/view/isoc_ec_ibos/default/table?lang=en
Number of products from outside versus inside the EU
211
Because the statistics are over a three-month period
584
In Table 180 the percentage of individuals making purchases in different locations has been
used to derive the implied distribution of products by origin. Whilst it could be argued that
the statistics by individual do not explicitly describe the proportion of purchases made by
location, there is no better data on which to base the assessment and the resulting percentage
split between locations so derived seems plausible.
The resulting percentages (in Table 180) have been applied to the total number of purchases
of physical goods in a three-month period (in Table 179) to make a split between purchases
of physical goods from EU sellers and extra EU sellers. The resulting values have been
multiplied by four to convert them from three-month figures to annual figures and are
provided in Table 182. As can be seen from the table, certain physical goods (such as
deliveries from restaurants) are unlikely to have been purchased from outside the EU and this
has been accounted for in the calculations.
The resulting total number of physical items purchased online from outside the EU is
estimated as around 583 million in 2020 and 693 million in 2021. In terms of comparison of
this with other data points, in 2017 it was estimated that around 150 million small
consignments imported free of VAT into the EU each year212
. The number of online
purchases/transactions has increased since that time. Using available and comparative data
from EUROSTAT for 2017 and 2021 suggests a multiplier of 1.375 to convert the 2017
estimate of 150 million into a 2021 estimate of around 206 million small VAT free
consignments for 2021. This represents some 30% of the 693 million total number of items.
In other words, the comparison would suggest that, in 2021, 30% of online purchases from
sellers outside the EU would be of a value less than €22 (the VAT free cut-off that applied
until July 2021). This does not seem unreasonable.
A further sense check of the data on both the number of purchases and the number of
consumers (in Table 181) is provided by calculating the average number of purchases per
consumer suggested by the data. As can be seen from Table 182, this comparison suggests
around 11 purchases per consumer per year on average for purchases from EU countries and
9 or 10 per consumer per year for extra EU purchases. This, gain, does not seem
unreasonable. Given the sense checks, the data in Table 182 are taken to be a fair
representation of the numbers and flow of physical goods to consumers from online
purchases and the number of consumers.
212
European Commission, Memo 2017 - Modernising VAT for e-commerce
https://ec.europa.eu/commission/presscorner/detail/en/MEMO_16_3746
585
Table 183: Purchases of physical goods online from within versus outside the EU (purchases/items per year)
Within EU Outside EU
2020 2021 2020 2021
Clothes (including sport
clothing), shoes or
accessories
472,369,831 527,162,805 118,092,45
8
154,093,74
3
Sports goods (excluding
sport clothing)
157,456,610 180,345,170 39,364,153 52,716,280
Children toys or childcare
items
128,828,136 152,599,759 32,207,034 44,606,083
Furniture, home accessories
or gardening products
214,713,560 221,963,286 53,678,390 64,881,576
Music as CDs, vinyls etc. 57,256,949 41,618,116 14,314,237 12,165,295
Films or series as DVDs,
Blu-ray etc.
57,256,949 41,618,116 14,314,237 12,165,295
Printed books, magazines or
newspapers
200,399,322 194,217,875 50,099,831 56,771,379
Computers, tablets, mobile
phones or accessories
200,399,322 180,345,170 50,099,831 52,716,280
Consumer electronics or
household appliances
143,142,373 138,727,054 35,785,593 40,550,985
Medicine or dietary
supplements such as
vitamins (online renewal of
prescriptions is not included)
171,770,848 152,599,759 42,942,712 44,606,083
Deliveries from restaurants,
fast-food chains, catering
services
268,391,950 304,772,666 0 0
Food or beverages from
stores or from meal-kits
providers
178,927,966 179,278,039 0 0
Cosmetics, beauty or
wellness products
200,399,322 208,090,581 50,099,831 60,826,477
Cleaning products or
personal hygiene products
114,513,898 110,981,643 28,628,475 32,440,788
Bicycles, mopeds, cars, or
other vehicles or their spare
parts
71,571,187 69,363,527 17,892,797 20,275,492
Other physical goods 143,142,373 152,599,759 35,785,593 44,606,083
Total purchases 2,780,540,598 2,856,283,32
5
583,305,17
0
693,421,84
3
Total individuals making
online purchases
248,262,553 250,989,254 62,624,788 69,470,240
Average purchases per
consumer per year
11.2 11.4 9.3 10.0
Number of non-compliant transactions
While not all of the categories of physical goods set out in Table 182 are entirely relevant
from the perspective of EU safety standards in general or requirements on chemicals under
CLP and REACH specifically, some are relevant.
586
A proportion of these goods will have been non-compliant, and the objective of the
interventions is to address this and ensure greater compliance in the future. For the IA, then,
an estimate of the percentage/number of REACH/CLP non-compliant online products needs
to be established for the following types of relevant products listed in Table 182 to establish a
baseline for the assessment:
Clothes (including sport clothing), shoes or accessories
Children toys or childcare items
Furniture, home accessories or gardening products
Computers, tablets, mobile phones or accessories
Consumer electronics or household appliances
Cosmetics, beauty or wellness products
Cleaning products or personal hygiene products
Bicycles, mopeds, cars, or other vehicles or their spare parts
To inform this estimation of non-compliance, available surveillance information on online
products has been gathered from a variety of consumer reports and enforcement projects.
Data on notifications to Safety Gate/RAPEX that was previously compiled for the IA of
GPSD has also been reviewed for relevance. However, as the GPSD IA Staff Working
Document identifies that only 25% of the notifications in the period from 2013 to 2019
included reference to a ‘chemical risk’ it was concluded that the data were not useful for the
current analysis.
The results of surveillance studies on online products have been collated as Table 183:. The
table provides information on reasons for non-compliance where this includes both
chemically relevant variables (relating to, for example, presence/concentration of restricted
substances or hazard information) and also other non-compliance issues (such as electrical
safety, choking hazards, etc.).
587
Table 184: Collated information on online product non-compliance
Product
Reference
number/
Number
tested/assessed
Non-
compliant
Non-
compliant
(%)
Requirement/reason Source Year
Non-compliance with chemicals related requirements
Online Cosmetics 21% Non-compliant - often owing to
lack of information on alergens
DGCCRF (Direction
générale de la
Concurrence, de la
Consommation et de la
Répression des fraudes)
2020 survey
2020
Online Cosmetics for
adults
39 22 56% No list of ingredients and
company information
BEUC report 2021
Online Cosmetics for
adults
39 1 3% Illegal substances BEUC report 2021
Online Teeth whitening
products
11 7 64% Hydrogen peroxide limits BEUC report 2021
Online Teeth whitening
products
11 11 100% Labelling and no
manufacturer/batch labels
BEUC report 2021
Online Children's
make-up
11 1 9% 425 x legal limit for lead BEUC report 2021
Online Children's
make-up
11 2 18% Legal limits on antimony BEUC report 2021
Online Children's
make-up
11 3 27% Legal limits substances BEUC report 2021
COSMETICS - average 37% Restrictions
Online Toys 193 18 9% Pthalate levels June 2020 Toy industry
survey
2020
Online Toys 193 7 4% Boron migration June 2020 Toy industry
survey
2020
588
Table 184: Collated information on online product non-compliance
Product
Reference
number/
Number
tested/assessed
Non-
compliant
Non-
compliant
(%)
Requirement/reason Source Year
Online Toys 82 12 15% Noncompliance with restriction:
Entry 51: Phthalates (DEHP,
DBP, BBP,
ECHA Ref 8 report 2020
Online Toys 94 2 2% Noncompliance with restriction:
Entry 52: Phthalates (DINP,
DIDP,
ECHA Ref 8 report 2020
Online Balloons 5 5 100% nitrosamines and/or nitrosatable
substances
BEUC report 2021
Online Balloons 5 2 40% 15 x limit for nitrosamines, 27 x
limit for nitrosatable substances
BEUC report 2021
Soft plastic toys 29 9 31% Above legal limits for one or
more Phthalates
BEUC report 2021
Online Acoustic toys 23 0 0% Legal limits on substances BEUC report 2021
Online Acoustic toys 23 4 17% German limits on PAHs BEUC report 2021
Online Toys and
childcare items
24% Not conforming to restrictions on
substances (KEMI enforcememnt
2014-2019)
Kemi - Increased e-
commerce – increased
chemicals risks?
2016
Online Toys and
childcare items
23% Not conforming to restrictions on
substances (Nordic e-commerce
project 2019)
Kemi - Increased e-
commerce – increased
chemicals risks?
2016
Online Childcare
articles
24 0 0% Noncompliance with restriction:
Entry 51: Phthalates (DEHP,
DBP, BBP,
ECHA Ref 8 report 2020
Online Childcare
articles
28 0 0% Noncompliance with restriction:
Entry 52: Phthalates (DINP,
DIDP,
ECHA Ref 8 report 2020
589
Table 184: Collated information on online product non-compliance
Product
Reference
number/
Number
tested/assessed
Non-
compliant
Non-
compliant
(%)
Requirement/reason Source Year
TOYS AND CHILDCARE ITEMS - average 20% Restrictions
Online Electrical
products
31% Not conforming to restrictions on
substances (KEMI enforcememnt
2014-2019)
Kemi - Increased e-
commerce – increased
chemicals risks?
2016
Online Electrical
products
57% Not conforming to restrictions on
substances (Nordic e-commerce
project 2019)
Kemi - Increased e-
commerce – increased
chemicals risks?
2016
ELECTRICAL PRODUCTS - average 44% Restrictions
Solder (for use in
soldering) - inside EU
40% Restrictions on lead ECHA Ref 8 report 2020
Solder (for use in
soldering) - outside EU
60% Restrictions on lead ECHA Ref 8 report 2020
Online Jewellery 340 79 23% Noncompliance with restriction:
Entry 23: Cadmium
ECHA Ref 8 report 2020
Online Jewellery 302 16 5% Noncompliance with restriction:
Entry 27: Nickel in jewellery
ECHA Ref 8 report 2020
Online Jewellery 337 31 9% Noncompliance with restriction:
Entry 63 Lead
ECHA Ref 8 report 2020
Online Jewelery 7 5 71% nickel and or cadmium BEUC report 2021
JEWELERY - average 27% restrictions
Online Leather articles 1 0 0% Noncompliance with restriction:
Entry 43: Azocolourants and
azodyes
ECHA Ref 8 report 2020
Online Leather articles 76 6 8% Noncompliance with restriction:
Entry 47. 5-7: Chromium VI in
leather articles
ECHA Ref 8 report 2020
590
Table 184: Collated information on online product non-compliance
Product
Reference
number/
Number
tested/assessed
Non-
compliant
Non-
compliant
(%)
Requirement/reason Source Year
Online Textiles 31 0 0% Noncompliance with restriction:
Entry 43: Azocolourants and
azodyes
ECHA Ref 8 report 2020
LEATHER AND TEXTILES – average 3% Restrictions
Online Plastic material 6 2 33% Noncompliance with restriction:
Entry 23: Cadmium
ECHA Ref 8 report 2020
Online Binoculars 17 16 94% Chlorinated paraffins, phthalates,
PAHs
BEUC report 2021
Online products
(substances, mixtures,
artcles)
5,730 5,047 88% Noncompliant for one or more
reasons
REF-8 (2020)* as
reported in ECHA Ref 8
report
2020
Online products
(substances, mixtures,
artcles)
3,391 1,398 41% Noncompliant for one or more
reasons
REF-6[2] (2018)* as
reported in ECHA Ref 8
report
2018
Online products
(substances, mixtures,
artcles)
2,629 2,042 78% Noncompliant with REACH
restrictions
ECHA Ref 8 report 2020
Online products
(substances, mixtures,
artcles)
5,625 1125 22% Noncompliant with REACH
restrictions
REF-411 (2016)* as
reported in ECHA Ref 8
report
2016
Online products
(substances, mixtures,
artcles)
1,225 211 17% Noncompliant with REACH
restrictions
Cooperation with
customs 2 project [1]
(2019)* as reported in
ECHA Ref 8 report
2018
Online
Substances/mixtures
1,974 1,876 95% Non compliance with restriction ECHA Ref 8 report 2020
Online Articles 655 164 25% Non compliance with restriction ECHA Ref 8 report 2020
591
Table 184: Collated information on online product non-compliance
Product
Reference
number/
Number
tested/assessed
Non-
compliant
Non-
compliant
(%)
Requirement/reason Source Year
Online Articles 7 2 29% Noncompliance with restriction:
Entry 63 Lead
ECHA Ref 8 report 2020
REACH (RESTRICTIONS) Online products
(substances, mixtures, artcles) - average
49%
Online products
(substances, mixtures,
artcles) from EU
marketplace
98% REACH restrictions ECHA Ref 8 report 2023
Online products
(substances, mixtures,
artcles) from NON-EU
marketplace
84% REACH restrictions ECHA Ref 8 report 2024
Online Articles from
marketplace
45% Non compliance with restriction ECHA Ref 8 report 2020
Online Arictles from
Webshop
18% Non compliance with restriction ECHA Ref 8 report 2020
Online products
(substances, mixtures,
artcles)
54% Noncompliant with CLP Article
48 (2)
REF-8 (2020)* as
reported in ECHA Ref 8
report
2020
Online products
(substances, mixtures,
artcles)
1,314 1,083 82% Noncompliant with CLP Article
48 (2)
e-commerce project[3]
(2017)* as reported in
ECHA Ref 8 report
2016
Online products
(substances, mixtures,
artcles)
2,752 2,065 75% non-compliant with CLP (Article
48(1) and (2))
ECHA Ref 8 report 2020
Online products
(substances, mixtures,
2,752 1,321 48% No hazard informtion CLP
(Article 48(1) and (2))
ECHA Ref 8 report 2020
592
Table 184: Collated information on online product non-compliance
Product
Reference
number/
Number
tested/assessed
Non-
compliant
Non-
compliant
(%)
Requirement/reason Source Year
artcles)
Online hazardous
mixture
1,335 92 7% Information provided was not
complete (e.g. missing hazard
statements, H-codes only instead
of full hazard statements)
ECHA Ref 8 report 2020
Online hazardous
mixture
1,335 626 47% No hazard information provided ECHA Ref 8 report 2020
Online hazardous
mixture
1,335 718 54% No or incomplete hazard
information
ECHA Ref 8 report 2020
Online hazardous
mixture
1,083 902 83% No information provided on
hazard statements and/or
supplementary hazard statements
ECHA Final report on the
Forum Pilot Project on
CLP focusing on control
of internet sales (2017)
2017
Online hazardous
mixture
1,083 55 5% The information on the hazard
statements provided is not
complete (e.g. H-codes instead of
phrases)
ECHA Final report on the
Forum Pilot Project on
CLP focusing on control
of internet sales (2017)
2017
Online hazardous
mixture
1,083 98 9% The text of the hazard statements
is not in the official language of
relevant MSs which are addressed
with the Article 48(2)
advertisement
ECHA Final report on the
Forum Pilot Project on
CLP focusing on control
of internet sales (2017)
2017
Online hazardous
mixture
1,083 172 16% Other non-compliance ECHA Final report on the
Forum Pilot Project on
CLP focusing on control
of internet sales (2017)
2017
CLP INORMATION Online products (substances, 70%
593
Table 184: Collated information on online product non-compliance
Product
Reference
number/
Number
tested/assessed
Non-
compliant
Non-
compliant
(%)
Requirement/reason Source Year
mixtures, articles) - average
Online products
(substances, mixtures,
artcles) from EU
marketplace
73% CLP ECHA Ref 8 report 2027
Online products
(substances, mixtures,
artcles) from NON-EU
marketplace
100% CLP ECHA Ref 8 report 2028
Online products
(substances, mixtures,
artcles)
956 49 5% REACH SDS (Article 31) ECHA Ref 8 report 2020
Online products
(substances, mixtures,
artcles) from EU
marketplace
16% READ SDS ECHA Ref 8 report 2025
Online products
(substances, mixtures,
artcles) from NON-EU
marketplace
0% READ SDS ECHA Ref 8 report 2026
Online products
(substances, mixtures,
artcles)
42% Non- compliant with BPR
Articles 17 and 89
REF-8 (2020)* as
reported in ECHA Ref 8
report
2020
Online products
(substances, mixtures,
artcles)
7% Non- compliant with BPR
Articles 17 and 89
REF-6[2] (2018)* as
reported in ECHA Ref 8
report
2018
Online products 1,153 891 77% Non compliant with BPR ECHA Ref 8 report 2020
594
Table 184: Collated information on online product non-compliance
Product
Reference
number/
Number
tested/assessed
Non-
compliant
Non-
compliant
(%)
Requirement/reason Source Year
(substances, mixtures,
artcles)
Online products
(substances, mixtures,
artcles) from EU
marketplace
89% BPR ECHA Ref 8 report 2029
Online products
(substances, mixtures,
artcles) from NON-EU
marketplace
100% BPR ECHA Ref 8 report 2030
Online products
(substances, mixtures,
artcles) from
marketplace
95% Non compliant with BPR,
REACH or CLP
ECHA Ref 8 report 2021
Online products
(substances, mixtures,
artcles) from webshop
65% Non compliant with BPR,
REACH or CLP
ECHA Ref 8 report 2022
Non-compliance with other (non-chemical related) requirements
Online Toys 58% Non-compliant only DGCCRF (Direction
générale de la
Concurrence, de la
Consommation et de la
Répression des fraudes)
2020 survey
2020
Online Toys 23% Non-compliant and dangerous
(suffocation, strangulation and
small parts)
DGCCRF (Direction
générale de la
Concurrence, de la
2020
595
Table 184: Collated information on online product non-compliance
Product
Reference
number/
Number
tested/assessed
Non-
compliant
Non-
compliant
(%)
Requirement/reason Source Year
Consommation et de la
Répression des fraudes)
2020 survey
Online Toys 193 55 28% Containing small parts June 2020 Toy industry
survey
2020
Online Toys 193 36 19% Packaging thickness June 2020 Toy industry
survey
2020
Online Toys 193 24 12% Shape and size June 2020 Toy industry
survey
2020
Online Toys 193 10 5% Access to stuffing material June 2020 Toy industry
survey
2020
Online Toys 193 10 5% Sharp points June 2020 Toy industry
survey
2020
Online Toys 193 7 4% Small ball release June 2020 Toy industry
survey
2020
Online Toys 193 6 3% Long cords June 2020 Toy industry
survey
2020
Online Toys 193 5 3% Suction cups June 2020 Toy industry
survey
2020
Online Toys 193 5 3% Short circuit June 2020 Toy industry
survey
2020
Online Toys 193 8 4% Other reason June 2020 Toy industry
survey
2020
Online Toys for <3 year
olds
21 19 90% Any aspect BEUC report 2021
Online Toys for <3 year
olds
21 12 57% Small parts BEUC report 2021
596
Table 184: Collated information on online product non-compliance
Product
Reference
number/
Number
tested/assessed
Non-
compliant
Non-
compliant
(%)
Requirement/reason Source Year
Online Toys for <3 year
olds
21 4 19% Choking hazard BEUC report 2021
Online Toys for <3 year
olds
21 2 10% Strangulation hazard BEUC report 2021
Online Toys for <3 year
olds
21 1 5% Accessible stuffing BEUC report 2021
Online Toys for <3 year
olds
21 2 10% Packaging issues BEUC report 2021
Online Toys for <3 year
olds
21 1 5% Battery accessible BEUC report 2021
Online Toys for <3 year
olds
21 2 10% Suffocation hazard BEUC report 2021
Online Teething toys 8 6 75% Small parts broke off in tests BEUC report 2021
Online Smoke detectors 9 4 44% Non-compliant only DGCCRF (Direction
générale de la
Concurrence, de la
Consommation et de la
Répression des fraudes)
2020 survey
2020
Online Smoke detectors 9 5 56% Non-compliant and dangerous DGCCRF (Direction
générale de la
Concurrence, de la
Consommation et de la
Répression des fraudes)
2020 survey
2020
Online Smoke detectors 4 4 100% Detection BEUC report 2021
597
Table 184: Collated information on online product non-compliance
Product
Reference
number/
Number
tested/assessed
Non-
compliant
Non-
compliant
(%)
Requirement/reason Source Year
Online Carbon
monoxide alarms
7 7 100% Detection and/or safety BEUC report 2021
Online Power banks 12 7 58% Electrical/fire safety BEUC report 2021
Online USB travel
adapters
12 11 92% Electrical/fire safety BEUC report 2021
Online USB chargers 12 8 67% Electrical/fire safety BEUC report 2021
Online Christmas tree
lights
13 12 92% Electrical/fire safety BEUC report 2021
Online Jewellery 38% Non-compliant and dangerous DGCCRF (Direction
générale de la
Concurrence, de la
Consommation et de la
Répression des fraudes)
2020 survey
2020
Online Chilrens
clothing
16 14 88% Safety requirements BEUC report 2021
Online Electrical
products
87% Electrical safety DGCCRF (Direction
générale de la
Concurrence, de la
Consommation et de la
Répression des fraudes)
2020 survey
2020
Online Motorcycle
helmets for children
3 2 67% Safety standards BEUC report 2021
Online consumer
products 2018-19
274 157 57% No manufacturer General Product Safety
Directive IA_SWD2021
2019
598
Table 184: Collated information on online product non-compliance
Product
Reference
number/
Number
tested/assessed
Non-
compliant
Non-
compliant
(%)
Requirement/reason Source Year
Online consumer
products 2018-19
274 100 36% No brand General Product Safety
Directive IA_SWD2021
2019
Online consumer
products 2018-19
274 80 29% No type/model General Product Safety
Directive IA_SWD2021
2019
Online consumer
products 2018-19
274 138 50% No batch number/barcode General Product Safety
Directive IA_SWD2021
2019
Online consumer
products 2018-19
274 35 13% None of the four General Product Safety
Directive IA_SWD2021
2019
NOT online consumer
products 2018-19
3,590 1,280 36% No manufacturer General Product Safety
Directive IA_SWD2021
2019
NOT online consumer
products 2018-19
3,590 700 19% No brand General Product Safety
Directive IA_SWD2021
2019
NOT online consumer
products 2018-19
3,590 451 13% No type/model General Product Safety
Directive IA_SWD2021
2019
NOT online consumer
products 2018-19
3,590 667 19% No batch number/barcode General Product Safety
Directive IA_SWD2021
2019
NOT online consumer
products 2018-19
3,590 17 0.5% None of the four General Product Safety
Directive IA_SWD2021
2019
599
It is important to note that almost all of the surveillance information provided in Table
183: relates to products sold online generally and does not distinguish between points of
origin in the EU versus outside the EU. Some of the information data relates to specific
products or product types and some of the information is more general, relating to ‘online
products’ consisting of substances, mixtures or articles. Average values for percentage
non-compliance with REACH Restrictions and CLP for different products/types of
product have also been provided in Table 183: and these are summarised in Table 184.
Table 185: Average of surveillance data values for products (from Table 183: overleaf)
CLP non-
compliance
REACH non-
compliance
(Restrictions)
COSMETICS - average
No data/not
applicable
37.3%
TOYS AND CHILDCARE ITEMS -
average
No data/not
applicable
20.4%
ELECTRICAL PRODUCTS - average
No data/not
applicable
44.0%
JEWELERY - average
No data/not
applicable
27.3%
LEATHER AND TEXTILES - average
No data/not
applicable
2.6%
Online products (substances, mixtures,
articles)
69.7% 49.4%
When reflecting on the averages derived from the surveillance data (Table 183: and
Table 184), it is worth noting that the approaches adopted in the surveillance are biased
towards specific products where the likelihood of non-compliance (or the risk) is likely to
be highest. As such, surveillance and enforcement does not adopt a representative
sampling approach of, for example, ‘toys’ but, rather, focuses on certain types (such as
‘soft plastic toys’) where non-compliance is most likely to be found and/or the
risk/exposure of the consumer/end user is highest. Regardless of this, these non-
compliance statistics provide the only basis from which to begin to attribute levels of
non-compliance to the various categories of products sold online.
Table 185 provides average non-compliance data from the surveillance reports (from
Table 183: and Table 184) mapped onto the most relevant product categories listed in in
the Eurostat e-commerce data. As can be seen from the table, there are no relevant
surveillance data that would apply to the categories ‘Furniture, home accessories or
gardening products’ and ‘Bicycles, mopeds, cars, or other vehicles or their spare parts’.
What values are available from the surveillance data are high for the reasons outlined
above (i.e. sampling approaches biased to high non-compliance risk products).
600
Table 186: Mapping of average surveillance data onto EUROSTAT e-commerce product categories
EUROSTAT e-
commerce data
category
Category from
surveillance data
Relevant average non-
compliance value from
surveillance data
CLP
REACH
(RESTRICTION)
Clothes (including
sport clothing), shoes
or accessories
LEATHER AND
TEXTILES - average
No data/not
applicable
3%
Children toys or
childcare items
TOYS AND
CHILDCARE ITEMS -
average
No data/not
applicable
20%
Furniture, home
accessories or
gardening products
No comparable category
in surveillance data
No data No data
Computers, tablets,
mobile phones or
accessories
ELECTRICAL
PRODUCTS - average
No data/not
applicable
44%
Consumer electronics
or household
appliances
ELECTRICAL
PRODUCTS - average
No data/not
applicable
44%
Cosmetics, beauty or
wellness products
COSMETICS - average
No data/not
applicable
37%
Cleaning products or
personal hygiene
products
Online products
(substances, mixtures,
articles) from EU
marketplace
70% 49%
Bicycles, mopeds, cars,
or other vehicles or
their spare parts
No comparable category
in surveillance data
No data No data
Expanding on and being informed by the values from surveillance reports, Table 186:
provides three baseline scenarios (Lower, Central and Upper) for percentage non-
compliance of online products sourced from sellers within the EU with CLP and REACH
requirements.
There is some evidence and some suspicion that products purchased directly from outside
the EU have higher levels of non-compliance than products purchased from within the
EU. Regarding CLP, the information from the Ref 8 report suggested 73% non-
compliance from products sourced from sellers within the EU compared with 100% non-
compliance for outside the EU. Thus, for CLP this would suggest levels of compliance
are 1.37 times higher than those within the EU (100/73).
601
Table 187: Mapping of average surveillance data onto Eurostat e-commerce product categories
EUROSTAT e-
commerce data
category
Category from
surveillance data
CLP
REACH
(RESTRICTION)
Clothes (including
sport clothing), shoes
or accessories
LEATHER AND
TEXTILES - average
No data/not
applicable
3%
Lower scenario - 2%
Central scenario - 3%
Upper scenario - 5%
Children toys or
childcare items
TOYS AND
CHILDCARE ITEMS -
average
No data/not
applicable
20%
Lower scenario - 3%
Central scenario - 5%
Upper scenario - 10%
Furniture, home
accessories or
gardening products
No comparable category
in surveillance data
No data No data
Lower scenario - 1%
Central scenario - 2%
Upper scenario - 3%
Computers, tablets,
mobile phones or
accessories
ELECTRICAL
PRODUCTS - average
No data/not
applicable
44%
Lower scenario - 5%
Central scenario - 8%
Upper scenario - 10%
Consumer electronics
or household
appliances
ELECTRICAL
PRODUCTS - average
No data/not
applicable
44%
Lower scenario - 5%
Central scenario - 8%
Upper scenario - 10%
Cosmetics, beauty or
wellness products
COSMETICS - average
No data/not
applicable
37%
Lower scenario - 3%
Central scenario - 5%
Upper scenario - 8%
Cleaning products or
personal hygiene
products
Online products
(substances, mixtures,
articles) from EU
marketplace
70% 49%
Lower scenario 10% 2%
Central scenario 15% 5%
Upper scenario 30% 10%
Bicycles, mopeds,
cars, or other vehicles
or their spare parts
No comparable category
in surveillance data
No data No data
Lower scenario - 1%
Central scenario - 2%
Upper scenario - 3%
For REACH compliance the available evidence is conflicting. One of the data points in
Table 183: from the Ref 8 report suggests 98% non-compliance for ‘online products’
sourced from sellers within the EU compared with 84% non-compliance for outside the
602
EU. In contrast, the only other data point (for lead in solder, also from the Ref 8 report)
suggests 40% non-compliance for the EU compared with 60% non-compliance for
outside the EU (i.e. 1.5x).
Considering thee values, lower, central and higher scenario assumptions for increased
levels of non-compliance with CLP and REACH are applied in the analysis. The
multipliers applied are provided in Table 187 and the resulting percentage non-
compliance in the scenarios by application of these to the scenarios in Table 186 are
provided in Table 188.
Table 188: Non-compliance of products sources from sellers outside the EU relative to sellers within
(multipliers)
CLP REACH (RESTRICTION)
Lower scenario 1.37 1.37
Central scenario 1.5 1.5
Upper scenario 2 2
603
Table 189: Resulting scenarios for levels of non-compliance of online products for the assessment
Within EU Outside EU
CLP
REACH
(RESTRIC
TION)
CLP
REACH
(RESTRIC
TION)
Clothes (including
sport clothing), shoes
or accessories
Lower scenario - 2% - 3%
Central
scenario
- 3% - 5%
Upper scenario - 5% - 10%
Children toys or
childcare items
Lower scenario - 3% - 4%
Central
scenario
- 5% - 8%
Upper scenario - 10% - 20%
Furniture, home
accessories or
gardening products
Lower scenario - 1% - 1%
Central
scenario
- 2% - 3%
Upper scenario - 3% - 6%
Computers, tablets,
mobile phones or
accessories
Lower scenario - 5% - 7%
Central
scenario
- 8% - 12%
Upper scenario - 10% - 20%
Consumer electronics
or household
appliances
Lower scenario - 5% - 7%
Central
scenario
- 8% - 12%
Upper scenario - 10% - 20%
Cosmetics, beauty or
wellness products
Lower scenario - 3% - 4%
Central
scenario
- 5% - 8%
Upper scenario - 8% - 16%
Cleaning products or
personal hygiene
products
Lower scenario 10% 2% 14% 3%
Central
scenario
15% 5% 23% 8%
Upper scenario 30% 10% 60% 20%
Bicycles, mopeds, cars,
or other vehicles or
their spare parts
Lower scenario - 1% - 1%
Central
scenario
- 2% - 3%
Upper scenario - 3% - 6%
Resulting numbers of non-compliant online products
The resulting total numbers of online products purchased and the number of CLP and
REACH non-compliant products for 2021 and 2022 and all of the three scenarios are
provided in Table 189. A breakdown of these numbers by product type for the year 2021
is provided for the central scenario in Table 190.
604
Table 190: Total number of online products purchased and number of CLP and REACH non-compliant
products purchased (millions of products) under each scenario
Location of
seller
Year
Total
purchases
(million)
Total
number of
consumers
(million)
CLP non-
compliant
(millions)
REACH
Restriction non-
compliant
(million)
Lower scenario
Within EU 2020 1,545.9 248.3 11.5 41.7
Outside EU 2020 386.5 62.6 3.9 14.3
Within EU 2021 1,609.2 251.0 11.1 42.5
Outside EU 2021 470.4 69.5 4.4 17.0
Central scenario
Within EU 2020 1,545.9 248.3 17.2 69.6
Outside EU 2020 386.5 62.6 6.4 26.1
Within EU 2021 1,609.2 251.0 16.6 70.8
Outside EU 2021 470.4 69.5 7.3 31.0
Upper scenario
Within EU 2020 1,545.9 248.3 34.4 106.9
Outside EU 2020 386.5 62.6 17.2 53.5
Within EU 2021 1,609.2 251.0 33.3 110.0
Outside EU 2021 470.4 69.5 19.5 64.3
605
Table 191: Breakdown of the online products purchased in 2021 for the Central Scenario
Total
purchases
(million)
CLP non-
compliant
(millions)
REACH
Restriction
non-compliant
(million)
Within EU - 2021
Clothes (including sport clothing), shoes or
accessories
527.2 0.0 15.8
Children toys or childcare items 152.6 0.0 7.6
Furniture, home accessories or gardening
products
222.0 0.0 4.4
Computers, tablets, mobile phones or
accessories
180.3 0.0 14.4
Consumer electronics or household
appliances
138.7 0.0 11.1
Cosmetics, beauty or wellness products 208.1 0.0 10.4
Cleaning products or personal hygiene
products
111.0 16.6 5.5
Bicycles, mopeds, cars, or other vehicles or
their spare parts
69.4 0.0 1.4
Total (million) 1,609.2 16.6 70.8
Total number of consumers (million) 251.0
Average purchases per consumer per
year
6.4
Outside EU - 2021
Clothes (including sport clothing), shoes or
accessories
154.1 6.9
Children toys or childcare items 44.6 0.0 3.3
Furniture, home accessories or gardening
products
64.9 0.0 1.9
Computers, tablets, mobile phones or
accessories
52.7 0.0 6.3
Consumer electronics or household
appliances
40.6 0.0 4.9
Cosmetics, beauty or wellness products 60.8 0.0 4.6
Cleaning products or personal hygiene
products
32.4 7.3 2.4
Bicycles, mopeds, cars, or other vehicles or
their spare parts
20.3 0.0 0.6
Total (million) 470.4 7.3 31.0
Total number of consumers (million) 69.5
Average purchases per consumer per
year
6.8
Interpretation and conclusions on the situation in 2021
The discussion in the following text focusses on the estimates for 2021 under the central
scenario. Here, the estimates in Table 189 and Table 190 would suggest the following:
 With respect to REACH restriction non-compliant items from sellers within the
EU:
606
In 2021 there were some 251 million consumers in the EU who purchased
goods online from sellers within the EU.
From sellers within the EU, these consumers purchased 1 609.2 million items
from categories of goods for which REACH restrictions are relevant for some
of the goods. This equates to an average of 6.4 products for each of the 251
million consumers.
70.8 million of the 1 609.2 million items purchased by these consumers from
sellers within the EU were not compliant with REACH restrictions.
This equates to an absolute maximum number of 70.8 million consumers
purchasing REACH non-compliant items from EU sellers (assuming one non-
compliant item per consumer) and an absolute minimum of 11 million
consumers purchasing REACH non-compliant items from EU sellers
(assuming that all 6.4 items on average purchased by these 11 million
consumers are REACH non-compliant products).
The average of these two estimates of consumers (70.8 million and 11 million)
would suggest 40.9 million consumers purchase an average of 1.7 REACH
non-compliant items per year from sellers within the EU. This is equivalent to
the following conclusion:
In 2021 40.9 million consumers purchased one REACH non-compliant item
from sellers within the EU and a further 14.9 million consumers purchased two
REACH non-compliant products from sellers within the EU – making a total
of 70.8 million REACH non-compliant items purchased from sellers within the
EU.
 With respect to REACH restriction non-compliant items from sellers outside the
EU:
In 2021 there were some 69.5 million consumers in the EU who purchased
goods online from sellers outside the EU. These consumers purchased 470.4
million items from categories of goods for which REACH restrictions are
relevant for some of the goods.
31 million of the 470.4 million items purchased by these consumers from
sellers outside the EU were not compliant with REACH restrictions.
Following the same logic as above, in 2021, 17.8 million consumers purchased
one REACH non-compliant item from sellers outside the EU and a further 6.6
million consumers purchased two REACH non-compliant products from
sellers outside the EU – making a total of 31 million REACH non-compliant
items purchased from sellers outside the EU.
 With respect to CLP non-compliant items from sellers within the EU:
o In 2021 there were some 251 million consumers in the EU who purchased
goods online from sellers within the EU. These consumers purchased 111
million items from categories of goods for which CLP requirements are
relevant for some of the goods.
o 16.6 million of the 111 million items purchased by these consumers from
sellers within the EU were not compliant with CLP requirements.
o Following the same logic as before, in 2021, 9.6 million consumers
purchased one CLP non-compliant item from sellers within the EU and a
further 3.5 million consumers purchased two CLP non-compliant products
from sellers within the EU – making a total of 16.6 million CLP non-
compliant items purchased from sellers within the EU.
607
 With respect to CLP non-compliant items from sellers outside the EU:
In 2021 there were some 69.5 million consumers in the EU who purchased
goods online from sellers outside the EU. These consumers purchased 32.4
million items from categories of goods for which CLP requirements are
relevant for some of the goods.
7.3 million of the 32.4 million items purchased by these consumers from
sellers outside the EU were not compliant with CLP requirements.
Following the same logic as before, in 2021, 4.2 million consumers purchased
one CLP non-compliant item from sellers outside the EU and a further 1.6
million consumers purchased two CLP non-compliant products from sellers
outside the EU – making a total of 7.3 million CLP non-compliant items
purchased from sellers outside the EU.
The number of non-compliant items and consumers of those items is summarised in
Table 191 for all three scenarios (lower, central and upper).
Table 192: Number of non-compliant items and consumers of those items
Non-compliance
issue
Location of
seller
Number of
non-
compliant
items
purchased per
year (million)
Number of consumers
purchasing
one non-
compliant
item per year
(million)
two non-
compliant items
per year
(million)
Lower scenario
REACH
restriction non-
compliant items
within EU 42.5 24.5 9.0
outside EU 17.0 9.8 3.6
CLP non-
compliant items
within EU 11.1 6.4 2.3
outside EU 4.4 2.6 0.9
Central scenario
REACH
restriction non-
compliant items
within EU 70.8 40.9 14.9
outside EU 31.0 17.8 6.6
CLP non-
compliant items
within EU 16.6 9.6 3.5
outside EU 7.3 4.2 1.6
Upper scenario
REACH
restriction non-
compliant items
within EU 110.0 63.6 23.2
outside EU 64.3 36.9 13.7
CLP non-
compliant items
within EU 33.3 19.2 7.0
outside EU 19.5 11.2 4.1
608
Annex 16 – Information Gaps for Poison Centres
CONTEXT
Appointed bodies responsible for receiving information relating to emergency health
response, colloquially known as “poison centres”, can provide only sub-optimal
emergency health response because they do (possibly) not have all available information
on mixtures in case of (i) cross-border distribution and/or (ii) re-branding/re-labelling.
This matter does not originate from the CSS or the Fitness Check. By implementing
Annex VIII to CLP regarding harmonised information to poison centres213
, it was
observed and discussed that certain relevant information is lacking and/or that there is
ambiguity on how to correctly implement Annex VIII.
PROBLEM
What is/are the problems?
Available information to poison centres in case of cross-border distribution and re-
branding/re-labelling
Article 45 of the CLP Regulation provides the obligation for downstream users and
importers to submit relevant information for emergency health response – but not for
distributors or any other type of supplier – in those Member States where they place
mixtures on the market. This legal structure, which excludes some actors in the supply
chain, could bring information loss for poison centres in the following cases:
Cross-border distribution: A distributor purchases a product in one Member State and
places it on the market in another one. In the original Member State information to the
national poison centre would have been submitted by the duty holder further up in the
supply chain. However, as it is not sufficiently clear from the current CLP text whether
distributers have the obligation to notify, no information would be available in the
receiving Member State.
Re-branding/re-labelling: The original supplier or a downstream supplier places the
mixture on the market in the same Member State but they just re-brand or re-label it
(without changing the composition or packaging). In such case, the mixture could only be
identified via the UFI and not via the brand name/label whereas the latter would be the
most obvious reference for consumers in case of an emergency. Explaining and looking
for the UFI on the label in a stressful situation may cost valuable time and is only
possible if the packaging is actually at hand.
Poison Centres across the European Union answer over half a million calls for support
per year, and approximately half of the cases are related to accidental exposures
involving children.214
Information loss for poison centres means having incomplete
emergency health response databases at national level, which results in not being able to
or provide incorrect/incomplete responses, leading to patients’ overtreatment or sending
them to the hospital/first aid.
213
Commission Delegated Regulations 2020/1676, 2020/1677, OJ L 379, p. 1 and 3.
214
https://ec.europa.eu/growth/sectors/chemicals/poison-centres_en
609
Following a Commission’s interpretation proposed in ECHA guidance, distributors and
any other types of supplier) are already bound to submit relevant information for medical
response in those cases where poison centres would otherwise be pre-empted from
carrying out their tasks by virtue of Article 4(10) providing for a general obligation to
comply with the CLP Regulation. Based on that interpretation certain distributors may
notify already (by following Art. 4(10)), hence reducing the scale of the problem from
significant to relatively significant.
Available information to poison centres on substances
Article 45 of the CLP Regulation does not provide for the obligation to submit
information on substances to appointed bodies (poison centres). Information to provide
emergency health response could be needed for substances too since not having that
information leads to the same consequences as outlined above.
Based on the consultations carried out, not submitting information on substances is
actually not a problem because poison centres retrieve data on substances from other
sources (e.g. data is available through the registered substance database, the classification
and labelling inventory, the product label), and cases where substances are the origin of a
poisoning incident are significantly less frequent. E.g., the German poison centre
indicated that between 2-4% of its 200 daily calls are estimated to be related to
substances, whereas data from the German Federal Institute for Risk Assessment (BfR),
who are collecting information on around 8 000 poisoning incidents at workplaces each
year, found that in 2020, for 23% of cases it was documented that a substance was the
causative agent. For this relatively high figure of 23%, additional factors which might
alleviate any concerns should be taken into account. In workplace situations typically
more information on response is available from the safety data sheet (SDS), hence there
is less need of information on substances. Also, the 23% figure refers to all incidents and
not only those where a poison centre was needed. Belgium reported that 350 out of
13,000 calls relate to substances and that for those cases poison centres do not have
difficulties to identify the substances. During the consultation of the expert group
CARACAL, experts of the competent authorities raised the issue that data additionally
submitted data on substances would overload their systems, which might already contain
substance-related information and make relevant information more difficult to retrieve.
What are the problem drivers?
Hazard communication across the supply chain is insufficient, therefore, many
downstream suppliers who do not have all available information on hazardous mixtures
are not able to notify the full set of information to poison centres (regulatory failure).
Article 45 and Annex VIII of the CLP Regulation do not specifically cater for the cases
of information loss mentioned above, whereas the obligation under Article 4(10) is very
generic. ECHA guidance provides clarification to the generic obligation under
Article 4(10) to comply with CLP and for distributors to submit in certain cases.
However, ECHA guidance is not legally binding and thus distributors might not consider
the obligations under Article 4(10), read in combination with ECHA’s guidance, binding.
Therefore, due to some ambiguity in the legislation, outcomes are sub-optimal. Either
mixture distributors might be aware of the applicable provisions but do not consider them
stringent/clear enough to comply with, or they might not even be aware of them (results
in insufficient supply chain communication). Legal clarity is needed for distributors to
comply with the applicable rules and to assure that all distributors obey to the same
obligations in order to create a level-playing field in the EU.
610
How likely is the problem to persist?
The problem is likely to persist since distributors will continue placing on the market
mixtures with a cross-border dimension and/or re-branding/re-labelling them. Data from
Eurostat215
shows that in 2020 intra-EU sales of chemicals accounted for EUR 496 billion
in 2020 (up from EUR 207 billion in 2002), which made up 17% of all intra-EU sales.
Without EU intervention, the scale of the problem may increase over time, mainly driven
by the growing trend in intra-EU sales. This applies in particular to countries with a high
number of EU borders as well as to small countries where cross-border distribution
happens or where chemicals are re-labelled to comply with the language requirements.
What is to be achieved - objectives
General objectives
The overall objective of improving submissions to poison centres is the protection of
human health as well as ensuring a good functioning of the internal market by enabling a
level-playing field for the supply of chemical mixtures in the EU.
Specific objectives
The CLP revision should improve legal clarity and compliance of the requirements
related to poison centre notifications by distributers and other supplier types.
To effectively and efficiently protect consumers, national poison centres (or appointed
bodies) need the best available information on chemicals placed on the market to which
users could be exposed and for which adequate and swift emergency health response is
needed. This objective is in line with SDG 3 good health and well-being.
Legislation should be drafted in a clear, simple and accurate manner to improve its
efficiency allowing duty holders to properly comply with it. This objective is in line with
SDG 16 peace, justice and strong institutions.
Poison centres should not be overwhelmed with unnecessary or duplicated information.
Hence, the need to only cater for those cases where information is currently not available
(no need for double-notifications if importers or downstream users already notified the
same mixture under the same brand/label in the same Member State). Also, there is no
need to submit information on substances if poison centres already have sufficient access
to such information.
WHAT ARE THE AVAILABLE POLICY OPTIONS?
What is the baseline from which options are assessed?
The baseline from which policy options are assessed is the currently applicable
regulatory framework, i.e. obligations by downstream users and importers as per
Article 45, by distributers and other supplier types as per Article 4(10), and clarifications
of those obligations enshrined in ECHA guidance. ECHA guidance already address the
problem the best way possible, therefore, improving ECHA guidance was not explored as
non-regulatory policy option (“no-policy-change” scenario). To solve the problem, no
not yet adopted legislation is relevant, so that only the applicable legislation and
guidance should be taken into account for addressing the problem. Based on
215
https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Intra-EU_trade_in_goods_-
_main_features#Intra-EU_trade_in_goods_by_main_product_groups
611
assumptions, a max. of 50% of distributors who should have to comply by virtue of
Article 4(10) adhere to the rules in reality. This reality scenario is not going to change
drastically within the next 20 years without any legislative intervention, thus the problem
continues existing.
The number of Notifications to Poison Centres (PCNs) received in 2021 was 1,444,290,
but submissions to multiple Member States can be made in a single notification.
Expanding the number of notifications to include all multiple submissions results in the
figures presented in the table below (almost 7.7 million notifications).
Table 193: Summary of population of EU Member States and notifications received by PCNs
Member State Population (2021) Number of Poison Centre submissions in 2021
Germany 83,155,031 583,493
France 67,439,599 478,053
Italy 59,257,566 604,775
Spain 47,394,223 414,199
Poland 37,840,001 444,448
Romania 19,186,201 244,333
Netherlands 17,475,415 316,837
Belgium 11,566,041 214,877
Czech Republic 10,701,777 268,901
Greece 10,682,547 251,609
Portugal 10,298,252 446,018
Sweden 10,379,295 250,240
Hungary 9,730,772 142,749
Austria 8,932,664 332,514
Bulgaria 6,916,548 221,832
Denmark 5,840,045 245,333
Finland 5,533,793 188,175
Slovakia 5,459,781 222,649
Ireland 5,006,907 218,503
Croatia 4,036,355 240,974
Lithuania 2,795,680 251,670
Slovenia 2,108,977 219,211
Latvia 1,893,223 223,510
Estonia 1,330,068 205,451
Cyprus 896,005 153,681
Luxembourg 634,730 116,029
Malta 516,100 199,217
Source: ECHA (2022) and Eurostat (2021).
See: https://ec.europa.eu/eurostat/databrowser/view/tps00001/default/table?lang=en
Number of distributors and distributed products
In order to quantitatively assess how many mixtures should be notified to prevent
information loss, estimations were carried out which might have their limitations or bring
about some levels of uncertainty.
612
To estimate the number of distributors in the EU, data from Eurostat was used on the
number of enterprises in the G46.12 (Agents involved in the sale of fuels, ores, metals
and industrial chemicals) and G46.75 (Wholesale of chemical products) codes. This gave
an estimate of 41,300 distributors.
To calculate the number of products placed on the market by each distributor, data on the
number of PCNs received during 2021 (1,444,290) was combined with data on the
number of manufacturers (28,168) and distributors (41,337) in the EU-27. Dividing the
number of PCNs with the combined number of manufacturers and distributors results in a
figure of approximately 20 products per company. This estimate assumes that all
distributors are complying with their requirements under Article 45. To provide an
estimate where there is zero compliance from distributors, the number of PCNs
(1,444,290) was divided by the number of manufacturers (28,168) to give an estimate of
approximately 50 products per company. If it is assumed the average portfolio size of
distributors is similar to the rest of the chemical industry, this gives an approximate
estimate of 825,000 – 2,100,000 products placed on the EU market by distributors each
year (41,337 x (20 – 50) = 825,000 – 2,100,000).
The following limitations are recognised with this approach:
 The number of PCNs submitted in 2021 only reflects notifications submitted due
to new products being brought to market or changes to existing products. It does
not provide an estimate of the total number of products each company currently
places on the market. It, therefore, underestimates the number of products per
company. However, historical data on PCNs submissions from ECHA is not
available.
 ECHA data does not provide the number of notifiers responsible for the
notification received, so broad assumptions have had to be made.
Number of distributors and distributed products traded intra-EU-27
To estimate the number of distributors purchasing chemical products from one Member
State and selling them in another, the following methodology was applied. For
distributors, data for the number of companies involved in imports and/or exports was
not available at the NACE Rev. 2 four-digit level – that is, for sectors G46.12 and
G46.75. Their number was estimated using available data in the following way:
1. The EU-27 total number of enterprises in each of the two distributing sectors
related to chemicals products (46.12 and 46.75) and in their 3-digit parent sector
(46.1 and 46.7) was taken from the Survey of Business Statistics
(SBS_NA_DT_R2), and the percentages of each of the 4-digit sectors over their
respective 3-digit sector was computed.
Table 194: Number of enterprises
NACE Number of enterprises
Percentage of parent
NACE
G46.7 239,260 100%
G46.1 547,112 100%
G46.75 26,455 11%
G46.12 16,559 3%
613
2. The number of enterprises involved in intra-EU-27 “imports”216
and the number
of enterprises involved in intra-EU-27 “exports” at the three-digit level was taken
from EXT_TEC09. That data covers only 15 EU-27 countries217
, so it was
rescaled using the percentages that these countries represent for the overall
number of companies in those two sectors (59% in sector 46.1 and 68% in sector
46.7). The largest number of companies between importing and exporting
companies was chosen under the assumption that there will be a large and
unknown overlap between companies doing imports and exports. However, the
final number of companies will likely be underestimated, if there are companies
that only do imports and companies that only do exports.
Table 195: Number of enterprises importing
NACE
Number of enterprises importing intra-EU
EU-15 EU-27
G46.7 57,150 84,083
G46.1 47,017 80,206
3. The percentage of enterprises involved in intra-EU-27 imports and in exports was
estimated by applying the percentage of total number of enterprises in the 4-digit
level sectors over the 3-digit parent sectors to the estimated number of companies
involved in imports and in exports at the 3-digit level sectors (see step 1).
Table 196: Number of enterprises importing intra-EU
NACE
Number of
enterprises
importing intra-
EU-27 in parent
NACE
Percentage of
parent NACE
Number of
enterprises
importing intra-
EU-27
G46.75 84,083 (G46.7) 11% 9,297
G46.12 80,206 (G46.1) 3% 2,428
Total
164,289 (G46.7 +
G46.1)
- 11,725
In total 11,725 distributors were estimates to trade chemicals products intra-EU-27,
which is 27% of the total number of distributors. 2019 data was used for this estimate, as
2020 data was incomplete. Applying this percentage to the number of distributors in
2020 (see Table 195) gives a figure of 11,160.
To calculate the number of intra-EU-27 traded products placed on the market, the
estimate of 20 – 50 products per company calculated earlier was applied to the estimate
of 11,160 distributors that import products intra-EU-27. Multiplying this data together
gives an approximate total of 220,000 – 560,000 products that are sold intra-EU.
Number of re-branders/re-labellers and re-labelled/re-branded products
216
Imports should be read as cross-border sales. Reference to import/export in this context is only made to
clarify the movement of goods entering and exiting another Member State.
217
The 15 countries covered are Belgium, Czechia, Germany (until 1990 former territory of the FRG),
Spain, France, Latvia, Lithuania, Luxembourg, Netherlands, Austria, Poland, Portugal, Romania, Slovenia
and Slovakia.
614
The information gap surrounding re-labellers and re-branders is due to mixtures being
purchased from suppliers and placed on the market in the same Member State as that in
which it was purchased, but with a different label or branding. Re-branders and re-
labellers are a type of distributor, so the starting point for estimating the number of re-
branders and re-labellers was estimated the number of distributors operating in a single
Member State.
Data from Cefic (2021) shows that 15% of the production value of chemical sales were
home sales (occurred in one Member State only). Applying this percentage to the number
of distributors in the EU-27 (41,337) gives a figure of 6,200 home sale distributors.
Multiple this by the average number of product per company (20 – 50) gives a total of
130,000 – 310,000, however only a proportion of these products will have been re-
branded or re-labelled. The exact proportion is unknown, but an estimate of 25% is
considered realistic, which would equate to 32,500 – 77,500.
Cost of non-Europe
As outlined below in heading 4.1, the entire poison centres format and notification
system was already significantly simplified without lowering the level of safety by
adopting the latest versions of Annex VIII on poison centres in 2020218
via delegated act.
Before adopting Annex VIII, a study by Kirhensteine et al. (2015) estimated that net cost
savings across the EU of €550 million per annum (equivalent to €40,000 per company)
could be achieved through harmonisation of the CLP Regulation (cost of Europe non
acting).
Conclusion
To summarise, estimates conclude that intra-EU distributors place between 220,000 –
560,000 products on another Member States’ market and re-branders/re-labellers
between 32,500 – 77,500 on their Member States’ market. This amounts to between
252,500 – 637,500 products distributed that should be notified. In reality a certain
percentage of that range will be notified already due to distributors adhering to
Article 4(10) of CLP, hence the number of not notified mixtures leading to information
loss will be lower than the range from 252,500 – 637,500 products.
Description of the policy measures
To solve the problem of having sub-optimal emergency health response for poison
centres due to insufficient information provided, the following measures were identified:
#21: Include in Article 45 an obligation for distributers and other types of suppliers
(including re-branders/re-labellers) to submit a notification in cases where no
notification was submitted yet by another actor in the supply chain to the relevant poison
centre in the Member State where the product will be placed on the market.
This regulatory measure is particular relevant in cases of:
- Cross-border distribution: A distributor purchases a product in one Member State
and places it on the market in another one. No information would be available in
the latter Member State.
- Re-branding/re-labelling: The original supplier or a downstream supplier place
the mixture on the market in the same Member State but they re-brand or re-label
218
Commission Delegated Regulations 2020/1676 and 2020/1677, OJ L 379, p. 1 and 3.
615
it219
. Then the mixture could only be identified via the UFI and not via the brand
name/label.
Including this obligation means that distributers and other suppliers need to make sure
that notifications exist already for the Member States in which they place their mixtures
on the market. This requires good supply chain communication with the upstream
supplier(s) who have detailed information about mixture compositions. Notification by
the upstream supplier (manufacturer, downstream user, importer) for all Member States
where their distributors place on the market is recommended, since then distributors may
simply refer to that notification. Instead, if no supply chain communication takes place
and if the distributor does not have access to the full composition information, it may opt
to, or, if the notification does not exist yet, has to notify the information contained in the
safety data sheet, which is less detailed. That way poison centres have less granular
information available.
This measure would cater for preventing both cases of information loss without obliging
each distributor to notify. A good supply chain communication is needed but can only be
recommended, otherwise poison centres end-up with having the least granular
information available (SDS information).
#19: Include in Article 45 a default obligation for distributers and other types of
suppliers to submit a notification, regardless whether poison centres already have the
relevant information.
Equally as for the previous measure, without a good supply chain communication poison
centres would end-up with having the least granular information available (SDS
information) as well as all distributors having the burden to notify.
#20: Introduce a new definition of re-brander/re-labeller in CLP under Article 2 and
include these actors in Article 45(3)
Currently CLP actor definitions are consistent with REACH and both legislations do not
contain the definition of re-brander. REACH guidance provides that a re-brander is an
“actor who affixes his own brand to a product that somebody else has manufactured” and
specifies that those actors fall under the definition of distributors220
.
This measure would misalign the actor definitions under REACH and CLP and hence be
incompatible with the overall principles that REACH and CLP should be as much as
possible aligned due to their closed interlinks221
. It would solve the problem of re-
branding/re-labelling but not of cross-border distribution (which concerns all
distributors). So it would bring about inconsistencies with REACH and provide only one
solution to two problems.
219
If they changed the composition or packaging in addition to re-branding/re-labelling, they would be
downstream users and needed to notify in any event.
220
See ECHA guidance for downstream users, table 8: Identification of roles – roles other than
downstream user or manufacturer/importer.
221
See Recital (12) of CLP stating that “The terms and definitions used in this Regulation should be
consistent with those set out in Regulation (EC) No 1907/2006 of the European Parliament and of the
Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of
Chemicals (REACH) (13), with those set out in the rules governing transport and with the definitions
specified at UN level in the GHS, in order to ensure maximum consistency in the application of chemicals
legislation within the Community in the context of global trade”.
616
DM14: Change the entire system and allow submissions via the ECHA portal only with
information storage in ECHA’s database and access by all Member States
Currently Article 45 sets forth that each Member State is responsible for the data notified
to their national appointed bodies only and the emergency response in their territory.
With this new measure, no distinction would be made as to which Member State
notifications should be sent and which Member State is ultimately responsible to keep
the data confidential. Member States would have to renounce on their national
submission systems and all notifications would run via ECHA to the Member States
(who could not collect national submission fees anymore). ECHA would become the data
owner and maintain responsibility for its confidentiality.
This measure was discarded given that both Member States and industry stakeholders did
not support it for the following reasons:
Disproportionate impact on existing databases and national notification systems, in
particular strong concerns that this would be very disruptive for a relatively recently
introduced system that works overall for relatively little added value
Strong concerns that language needs could be an issue;
The measure would not solve the issue of re-branding/re-labelling.
SCREENING OF POLICY MEASURES – WHAT ARE THE IMPACTS OF THE POLICY
MEASURES?
In order to quantitatively assess the impacts of the different policy measures, estimations
were carried out which might have their limitations or bring about some levels of
uncertainty.
The kind of economic, social and environmental impacts of measures #21, #19, #20 are
the same, albeit with different magnitudes (see comparison).
Economic impacts
All policy measures would have moderately negative impacts on the administrative
burden on businesses and public authorities, and potentially high negative impacts on the
operating costs and the conduct of business. All policy measures are likely to have a
positive market impact in levelling the playing field across the EU.
Administrative burden on business
Administrative burden on business depends on how well supply chain communication
works. Distributors who get the UFI from their upstream supplier bear much less costs
than distributors who start a notification from scratch. Costs per notification can amount
to 70 EUR for those suppliers carrying over the UFI code or communicating well with
their upstream supplier (lower bandwidth)222
. Starting notifications from scratch is much
more costly. The Commission’s Study on the harmonisation of the information to be
submitted to Poison Centres, according to article 45 (4) of the regulation (EC)
222
Study on the harmonisation of the information to be submitted to Poison Centres, according to article 45
(4) of the regulation (EC) No. 1272/2008 (CLP Regulation), DocsRoom - European Commission
(europa.eu), p. 61. The cost of an SDS submission under the national system amounts to 70EUR , which
can be taken as a reference value for a notification knowing the UFI.
617
No 1272/2008 (CLP Regulation)223
, estimated that an average notification cost of a
harmonised notifications should be €220 (upper bandwidth).
One-off and annualised costs
Estimates show that approximately 11,725 distributors supply chemicals intra-EU-27 of
the total number of chemicals distributors (approx. 41,337). Based on estimations,
distributors have a product portfolio between 20-50 mixtures224
.
By not calculating twice cross-border distributors and re-branders/re-labellers, estimates
of the latter regarded only re-labellers/re-branders operating in their Member State. Data
from Cefic (2021) shows that 15% of the production value of chemical sales were home
sales (occurred in one Member State only). Applying this percentage to the number of
distributors in the EU-27 (41,337) gives a figure of 6,200 home sale distributors.
Multiple this by the average number of product per company (20 – 50) gives a total of
130,000 – 310,000, however only a proportion of these products will have been re-
branded or re-labelled. The exact proportion is unknown, but an estimate of 25% is
considered realistic, which would equate to 32,500 – 77,500 re-branders/re-labellers who
have to notify.
Based on a reality assumption of the current and evolving baseline, 50% of distributors
will already comply with Article 4(10) of CLP, hence, they notify in cases where poison
centres’ access to information would jeopardise their activities (relevant for all measures
#21, #20, #21). Therefore, the following table contains two columns (figures with no and
a 50% compliance rate).
223
Ibid.
224
To calculate the number of products placed on the market by each distributor, data on the number of
PCNs received during 2021 (1,444,290) was combined with data on the number of manufacturers (28,168)
and distributors (41,337) in the EU-27. Dividing the number of PCNs with the combined number of
manufacturers and distributors results in a figure of approximately 20 products per company. This estimate
assumes that all distributors are complying with their requirements under Article 45. To provide an
estimate where there is zero compliance from distributors, the number of PCNs (1,444,290) was divided by
the number of manufacturers (28,168) to give an estimate of approximately 50 products per company.
618
Table 197: One-off and annualised cost
Submissions
Cost (in million
EUR) –
compliance rate
of 50%*
Annualised
Cost (in
million EUR )
– no
compliance
rate**
Annualised
#21
252,500 –
637,500 (no
compliance
rate)
8.9 – 22.3 (lower
bandwidth)
27.8 – 70.2 (upper
bandwidth)
0.6 – 1.5 (lower
bandwidth)
1.9 – 4.7 (upper
bandwidth)
17.7 – 44.6
(lower
bandwidth)
55.5 – 140.3
(upper
bandwidth)
1.2 – 3.0 (lower
bandwidth)
3.8 – 9.4 (upper
bandwidth)
#19
826,740 –
2,066,850 (no
compliance
rate)
28.9 – 72.3 (lower
bandwidth)
90.9 – 227.4
(upper bandwidth)
1.9 – 4.9 (lower
bandwidth)
6.1 – 15.3
(upper
bandwidth)
57.9 – 144.7
(lower
bandwidth)
181.7 – 454.7
(upper
bandwidth)
3.8 – 9.8 (lower
bandwidth)
12.2 – 30.6 (upper
bandwidth)
#20
32,500 – 77,500
(no compliance
rate)
1.1 – 2.7 – lower
bandwidth
3.6 – 8.5 – upper
bandwidth
0.07 – 0.18
(lower
bandwidth)
0.2 – 0.6 (upper
bandwidth
2.3 – 5.4 –
(lower
bandwidth)
7.2 – 17.1 –
(upper
bandwidth)
0.14 – 0.36 (lower
bandwidth)
0.5 – 1.1 (upper
bandwidth)
*Cost calculated for lower bandwidth: 70 EUR per submission; **Costs for upper bandwidth: 220 EUR per submission
Recurrent costs
The 2018 Evaluation of the Detergents Regulation estimates that half of all consumer
detergent products are reformulated every two years, while the other half are
reformulated every five years. If we take this as representative of all products, this
equates to 35% of products being reformulated each year. The Evaluation also estimates
that the product label is updated 60% to 70% of the time when consumer detergent
products are reformulated. This implies that in the remaining 30 - 40% of cases, changes
are not significant enough to trigger relabelling or submitting updated notifications to
poison centres. Taking the midpoint (65%) and applying this to the 35% of products
reformulated each year, equates to approximately 23% of products which would require
new PCNs each year. Therefore, this table presents recurrent costs as 23% of the one-off
costs.
619
Table 198: Recurrent costs
Submissions
Cost (in
million EUR)
– compliance
rate of 50%
Annualised225
Cost (in
million EUR )
– no
compliance
rate
Annualised226
#21
58,075 –
146,625 (no
compliance
rate)
2.0 – 5.1
(lower
bandwidth)
6.4 – 16.1
(upper
bandwidth)
2.7 – 6.9
(lower
bandwidth)
8.6 – 21.6
(upper
bandwidth
4.1 – 10.3
(lower
bandwidth)
12.8 – 32.3
(upper
bandwidth)
5.4 – 13.8
(lower
bandwidth)
17.2 – 43.2
(upper
bandwidth)
#19
190,150 –
475,375 (no
compliance
rate)
6.7 – 16.6
(lower
bandwidth)
20.9 – 52.3
(upper
bandwidth)
9.0 – 22.3
(lower
bandwidth)
28.0 – 70.3
(upper
bandwidth)
13.3 – 33.3
(lower
bandwidth)
41.8 – 104.6
(upper
bandwidth)
18.0 – 44.6
(lower
bandwidth)
56.0 – 140.6
(upper
bandwidth)
#20
7,475 –
17,825 (no
compliance
rate)
0.3 – 0.7 –
lower
bandwidth
0.8 – 2.2 –
upper
bandwidth
0.4 – 0.9 –
lower
bandwidth
1.1 – 3.0 –
upper
bandwidth
0.5 – 1.2 –
lower
bandwidth
1.6 – 3.9 –
upper
bandwidth
0.8 – 2.0 –
lower
bandwidth
2.2 – 6.0 –
upper
bandwidth
Operational costs to Member States
These relate to the increase in annual running costs of poison centres (IT systems etc.)
and more staff needs to review the notifications. This is alleviated by ECHA providing a
centralised dispatch mechanism and searchable database to which Member States is
gained access for free (they would just have to adapt their national IT systems to receive
the data).
Concerning the burden for SMEs, the overall cost can be expected to be less than that of
large enterprises given that SMEs do not distribute cross-border. However, they might re-
brand/re-label and those costs may be greater in relative terms to their income from the
sale of these products.
Social impacts
Regarding the social impacts, no quantitative estimates were possible to make due to lack
of data.
225
Annualised costs are the same as the recurring costs because we apply a 4% discount rate, but we
assume a 4% inflation figure.
226
Annualised costs are the same as the recurring costs because we apply a 4% discount rate, but we
assume a 4% inflation figure.
620
From a qualitative point of view, clarifying the scope of obligations under Art. 45 will
lead to better and more timely medical advice being given, thus reducing the number of
severity of cases of ill health, and instances where overtreatment is given.
It has been estimated through contact with the EU Poison Centres that on average these
services receive and treat 600,000 calls per year (almost 1,700 calls per day, mostly
related to child exposure) and the number of fatalities related to chemical exposure is
more than 400 per year227
. Further breakdown of these calls to identify trends within
specific products groups as well as the volume and nature of more serious incidents is
also covered as part of the work of these centres. For example, an indicative breakdown
of call volume by severity includes228
:
Germany - Poisoning cases related to chemicals exposure from one of the German Poison
Centres were 11,470 in 2013 and they had 120 severe symptoms and 6 fatalities (this
centre represents ~ 16% of Germany). Scaling this up assuming full proportionality and
representativeness results in around 70,000 calls, 750 cases with severe symptoms and
around 40 fatalities for the whole of Germany.
Italy - The Milan Poison Centre reported 16,000 cases in 2009 including 6 fatalities. By
extrapolation, this suggests there could be approximately 21,000 cases for the whole of
Italy and 8 fatalities (the Milan Poison Centre covers around 75% of the country).
France – The Nancy Poison Centre reported that for France as a whole the French Poison
Centres attended to 85,000 call per annum. There were also around 300 fatalities per
annum as a result of exposure to hazardous chemicals.
The Netherlands received 43,334 calls in 2013, of which 2,882 (or 12%) concerned
chemical products.
Spain - In 2014 the Spanish PC (INTCF) received about 71,000 calls for actual exposure
(other consultations are excluded; e.g. preventive measures). Accidental exposure to
chemicals: accounted for about 29,000 calls.
Quantitatively, the Fitness Check provides average economic costs for society of €16,618
(€967 for hospitalisation + €15,651 for severe eye impairment) for a severe incident and
€70.50 – €306 (example for a day of respiratory symptoms) for a minor incident.
Economic analysis undertaken by the National Chemical Emergency Centre (NCEC) in
the UK provide some justification for the estimate provided in the Fitness Check. The
analysis found that each emergency call brought health benefits of approximately €8,100
based on avoidance of fatal and non-fatal injury, incidents of ill-health, and savings in
hospital visits, ambulance call-outs, and doctor consultations. As well as the benefits
from avoiding cases of injury and ill-health, there is the reduction in the time spent by
emergency services, delays to road users from emergency services, and avoided
productivity losses to businesses. 2019-2020 data from the NCEC estimates a benefit of
around €1,075 saving per emergency call for time spent by emergency services, a €3,175
saving in time lost by road users per call, and a €530 saving in health costs to businesses
per call. These additional benefits equalled €4,780, meaning the total benefits per
227
Study on the harmonisation of the information to be submitted to Poison Centres, according to article 45
(4) of the regulation (EC) No. 1272/2008 (CLP Regulation), DocsRoom - European Commission
(europa.eu)
228
Ibid.
621
emergency call are €12,880. All estimates were converted to Euros and adjusted to 2021
prices229
.
Environmental impacts
No negative or positive environmental impacts are expected from the policy measures
since Article 45 does not target environmental hazards.
A summary of the costs and benefits of each of the three policy options is provided
below:
Summary of cost and benefits of policy options #19, #20, and #21
Policy measure #19 Policy measure
#20
Policy measure
#21
Costs - businesses
Total one-off costs over a 20-year
period
€28,900,000 –
€227,400,000 (mid-
estimate:
€128,150,000)
€1,100,000 –
€8,500,000 (mid-
estimate:
€4,800,000)
€8,900,000 –
€70,200,000
(mid-estimate:
€39,550,000)
Recurring costs every 1 year €6,700,000 –
€52,300,000 (mid-
estimate:
€29,500,000)
€300,000 –
€2,200,000 (mid-
estimate:
€1,250,000)
€2,000,000 –
€16,100,000
(mid-estimate:
€9,050,000)
Total recurring costs over a 20-year
period
€127,300,000 –
€993,700,000 (mid-
estimate:
€560,500,000)
€5,700,000 –
€41,800,000
(mid-estimate:
€23,750,000)
€38,000,000 –
€305,900,000
(mid-estimate:
€171,950,000)
PV of one-off costs (20 years; 3%) €38,850,679 –
€305,697,038 (mid-
estimate:
€172,273,859)
€1,478,746 –
€11,426,670
(mid-estimate:
€6,452,708)
€11,964,396 –
€94,370,853
(mid-estimate:
€53,167,625)
PV of one-off costs (20 years; 3%)
(annualised)
€1,942,534 –
€15,284,852 (mid-
estimate:
€8,613,693)
€73,937 –
€571,334 (mid-
estimate:
€322,635)
€598,220 –
€4,718,543
(mid-estimate:
€2,658,381)
PV of recurring costs (20 years; 3%) €171,131,192 –
€1,335,844,973
(mid-estimate:
€753,488,082)
€7,662,591 –
€56,192,332
(mid-estimate:
€31,927,461)
€51,083,938 –
€411,225,699
(mid-estimate:
€231,154,818)
Total PV – costs - businesses €209,981,871 –
€1,641,542,011
(mid-estimate:
€925,761-941)
€9,141,336 –
€67,619,002
(mid-estimate:
€38,380,169)
€63,048,334 –
€505,596,553
(mid-estimate:
€284,322,443)
Costs – public authorities
Total one-off costs over a 20-year
period
Recurring costs every 1 year
Total recurring costs over a 20-year
period
PV of one-off costs (20 years; 3%)
PV of recurring costs (20 years; 3%)
229
24/7 chemical helpline - NCEC (the-ncec.com)
622
Total PV – costs – public authorities
Total PV cost of policy option #19 €209,981,871 –
€1,641,542,011 (mid-
estimate: €925,761-
941)
€9,141,336 –
€67,619,002
(mid-estimate:
€38,380,169)
€63,048,334 –
€505,596,553
(mid-estimate:
€284,322,443)
Benefits (cost savings) - businesses
PV benefits - businesses
Benefits (cost savings) – public
authorities
PV – benefits – public authorities
Benefits - society
PV - benefits - society
Total OV - benefits
Net Present Value - NPV (PV
benefits – PV costs)
-€209,981,871 – -
€1,641,542,011
(mid-estimate: -
€925,761-941)
-€9,141,336 – -
€67,619,002
(mid-estimate: -
38,380,169)
-€63,048,334 –
-€505,596,553
(mid-estimate: -
€284,322,443)
A summary of the present value (3% discount) costs and benefits of each policy measure are
presented below.
Summary of costs and benefits (PV; 20 years; 3%) of policy measure #19 by type
Costs
Businesses Administrations Society
Direct adjustment
costs
Direct
administrative costs
€209,981,871 –
€1,641,542,011 (mid-
estimate: €925,761-
941)
Direct regulatory
fees and charges
Indirect costs
Benefits
Description Businesses Administrations Society
Direct benefits
Summary of costs and benefits (PV; 20 years; 3%) of policy measure #20 by type
Costs
Businesses Administrations Society
Direct adjustment
costs
Direct
administrative costs
€9,141,336 –
€67,619,002 (mid-
estimate: €38,380,169)
Direct regulatory
fees and charges
Indirect costs
Benefits
623
Description Businesses Administrations Society
Direct benefits
Indirect benefits
Summary of costs and benefits (PV; 20 years; 3%) of policy measure #21 by type
Costs
Businesses Administrations Society
Direct adjustment
costs
Direct
administrative costs
€63,048,334 –
€505,596,553 (mid-
estimate: €284,322,443)
Direct regulatory
fees and charges
Indirect costs
Benefits
Description Businesses Administrations Society
Direct benefits
Indirect benefits
624
Summary of impacts
Table 199: Summary of impacts
Economic impact Env Social PO
Business Administration
One-off Recurrent
Total
annualised
One-off Recurrent
Total
annualised
#21 Provide obligation for
distributors to notify in case
of information loss (cross-
border distribution or re-
branding/re-labelling).
Weakly
negative
Weakly
negative
Weakly
negative
Weakly
negative
Weakly
negative
Weakly
negative
No / limited
impact
Strongly
positive
Y
#19 Include default
obligation to submit for
suppliers (all distributors) in
Article 45
Strongly
negative
Weakly
negative
Weakly
negative
Strongly
negative
Strongly
negative
Strongly
negative
No / limited
impact
Strongly
positive
N
#20
Introduce new definition of
re-brander/re-labeller under
Art. 2 and include them in
the scope of Article 45
Weakly
negative
Weakly
negative
Weakly
negative
Weakly
negative
Weakly
negative
Weakly
negative
No / limited
impact
Weakly
positive (no
solution for
cross-border
distributions)
N
625
PREFERRED OPTION
Preferred measure
#21 is the preferred measure. #21: This measure would cater for preventing both cases of
information loss without obliging each distributor to notify by default. First the
distributor would have to check if a notification is required and only then it would have
to notify. To carry out such checks, a good supply chain communication with the
upstream supplier(s) is paramount for both (i) alleviating the downstream supplier’s
burden of notification and (ii) providing poison centres the utmost detailed information
(as a last resort, they may end-up with the SDS information). #19 has more economic
impacts on business and administration than measure #20 and results in the same
strongly positive social impact. Measure #20 would have a weakly negative impact on
businesses and administration and be better than #21, but worse from a social impact
perspective since it does not cater a solution for cross-border distribution. More, it would
bring incoherence to the CLP/REACH framework.
REFIT (simplification and improved efficiency)
In order to make the provision of information requirements for poison centres optimal
and not merely sub-optimal, no further simplification is possible given that , the entire
poison centres format and notification system was already simplified and made workable
by adopting the latest version of Annex VIII in 2020230
via delegated act. However,
SM(a) is the best available measure without disrupting the system. The mainly regulatory
failure at hand could not be addressed at the time via delegated act. Yet, the overall
achievements in terms of simplification and efficiency obtained with the delegated act
should be considered when overall comparing the additional economic costs with the
health benefits. I.e., the assessment should be cost savings due to harmonisation minus
additional costs for distributors compared to overall health benefits. Before introducing
harmonised requirements to notify information on emergency health response, the
Commission review revealed that multiple submissions needed to be provided, diversity
lead to inconsistencies in the information available for poison centres, and a cost and
benefit study of the Commission confirmed that the harmonisation would overall lead to
significant cost savings (overall, harmonisation could lead to savings of perhaps 900
million EUR per year for companies and the introduction of the UFI could lead to total
costs of around 340 million EUR per year with total net savings of 550 million EUR per
year, cost of “non-Europe”). Although the introduction of the new measure for
distributors and other types of suppliers will lead to additional costs, the impact
assessment demonstrated that those will not outweigh the overall savings and benefits of
the system and make it even more coherent and complete.
230
Commission Regulation 1676/2020 and 1677/2020, OJ L379/1 and /3.
626
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REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE
COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE
COMMITTEE OF THE REGIONS Findings of the Fitness Check of the most relevant
chemicals legislation (excluding REACH) and identified challenges, gaps and weaknesses
(COM/2019/264 final): https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1561530857605&uri=COM:2019:264:FIN
Results on the performance of the Simplified Label with QR code may be found further
COMMISSION STAFF WORKING DOCUMENT FITNESS CHECK of the most relevant
chemicals legislation (excluding REACH), as well as related aspects of legislation applied to
downstream industries Accompanying the document REPORT FROM THE COMMISSION
TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC
AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Findings of
the Fitness Check of the most relevant chemicals legislation (excluding REACH) and
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EN EN
EUROPEAN
COMMISSION
Brussels, 19.12.2022
SWD(2022) 435 final
PART 2/5
COMMISSION STAFF WORKING DOCUMENT
IMPACT ASSESSMENT REPORT
Accompanying the document
Proposal for a Regulation of the European Parliament and of the Council
amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council
on classification, labelling and packaging of substances and mixtures
{COM(2022) 748 final} - {SEC(2022) 452 final} - {SWD(2022) 434 final} -
{SWD(2022) 436 final}
Offentligt
KOM (2022) 0748 - SWD-dokument
Europaudvalget 2022
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Annex 1 – Procedural information
LEAD DG, DECIDE PLANNING/CWP REFERENCES
The preparation of this Impact Assessment Report was led by DG Environment (ENV) and DG
Internal Market, Industry, Entrepreneurship and SMEs (GROW).
The agenda planning reference is PLAN/2021/10629.
The initiative, to which this impact assessment relates, is referenced in the 2022 Commission
Work Programme1
, under the policy objective 1. Zero pollution package.
ORGANISATION AND TIMING
The revision of the CLP Regulation (Regulation (EC) No 1272/2008 on the classification,
labelling, and packaging of substances and mixtures) is a core deliverable under the European
Green Deal and the Chemicals Strategy for Sustainability.
The Inception Impact Assessment was published on the “Have your say” website on
4 May 2021 with a feedback period until 1 June 20212
. 182 comments were received and taken
into account to develop the impact assessment.
The Inter Service Steering Group (ISSG) for the Impact Assessment was set up by DG ENV
and DG GROW, who are co-responsible for CLP. It included the following DGs and services:
BUDG (Budget), CLIMA (Climate Action), COMP (Competition), CONNECT
(Communications Networks, Content and Technology), ECFIN (Economic and Financial
Affairs), EEAS (European External Action Service), EMPL (Employment, Social Affairs and
Inclusion), ENER (Energy), Eurostat, FPI (Foreign Policy Instruments), INTPA (International
Partnerships), JRC (Joint Research Centre), JUST (Justice and Consumers), MARE (Maritime
Affairs and Fisheries), MOVE (Mobility and Transport), NEAR (European Neighbourhood
and Enlargement Negotiations), OLAF (European Anti-Fraud Office), REGIO (Regional and
Urban Policy), RTD (Research and Innovation), SANTE (Health and Food Safety), SG
(Secretariat-General), TAXUD (Taxation and Customs Union), TRADE, as well as ECHA
(European Chemicals Agency) and EFSA (European Food Safety Authority). A total of 7
meetings of the ISSG were organised between spring 2021 and spring 2022: more specifically,
meetings were held on 31/05/21, 15/10/21, 18/01/22, 17/02/22, 14/03/22, 28/03/2022 and
06/04/2022.
The ISSG meetings discussed the main milestones in the process, in particular the following:
the Inception Impact Assessment, evidence gathering, coherence with other ongoing draft
legislative initiatives, the consultation strategy and main stakeholder consultation activities.
An open public consultation, intended to gather opinions on the revision, was open for a
duration of 14 weeks from 9 August 2021 to 15 November 2021. Moreover, a targeted
stakeholder survey was open for a duration of 6 weeks, from 10 November to 22 December
2021. The latter was intended to gather opinions on the CLP revision from Member State
1
COM(2021) 645
2
European Commission, Revision of EU legislation on hazard classification, labelling and packaging of
chemicals, available at: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12975-Revision-
of-EU-legislation-on-hazard-classification-labelling-and-packaging-of-chemicals_en
56
authorities/competent bodies, representatives of EU industry associations/EU- and national-
level worker representative groups/trade unions, NGOs/environmental charities and consumer
associations, academics/experts, as well as SMEs and retail.
In addition, the progress and updates of the impact assessment activities were presented at the
following open session meetings of the Competent Authorities for REACH and CLP
(CARACAL)3
expert group: CARACAL-40 (29-30 June 2021) and CARACAL-42 (17-18
November 2021). These meetings were attended by Member State Competent Authorities and
accredited stakeholder organisations, and in their framework discussions were held and
feedback was given.
Furthermore, extensive discussions on specific issues of CLP revision were held in 4 ad hoc
meetings of CARACAL on CLP revision, with wide Member State and stakeholder
participation: CARACAL on Persistent, Mobile and Toxic, very Persistent and very Mobile,
Persistent, Bioaccumulative and Toxic, very Persistent and very Bioaccumulative (PMT, vPvM
and PBT, vPvB) substances (30 September 2021), CARACAL on Annex VIII (Poison Centres)
and Online Sales (27 October 2021), CARACAL on harmonised classification and labelling
(CLH) prioritisation, Predicted No-Effect Concentration (PNEC), Derived No-Effect Level
(DNEL), Derived Minimal Effect Level (DMEL) and Labelling (6 December 2021) and
CARACAL on New Hazard Classes, More than One Constituent Substances (MOCS) and Self-
classification, (14 December 2021). Relevant discussions on specific topics covered by this
Staff Working Document were also held previously in CARACAL meetings (e.g. self-
classification, labelling, poison centres) or in meetings of specific groups as e.g. the Competent
Authorities Sub-Group on Endocrine Disruptors and the ECHA PBT Expert Group where
stakeholder representatives were also present. Finally, a stakeholder workshop on the
simplification and digitalisation of labelling requirements for chemicals was held on 26
November 2021.
CONSULTATION OF THE RSB
An informal upstream meeting with the RSB took place on 6 October 2021. The feedback after
this this meeting is provided below. It will be deleted and replaced with the opinion that will
be delivered after the meeting with the Board on 11 May 2022.
Context
 The IA needs to differentiate between the political context emerging from the
Chemicals Strategy and the available evidence of the problems, which the initiative
aims to tackle. The impact assessment should be based on robust evidence.
 The interrelationship of the different pieces of upstream and downstream legislation
and their respective roles should be well described in the IA report.
 The report should be very clear on the correlation and links of this proposal with
REACH and other legislation and initiatives, including on digital services. The
correlation of this proposal with the initiative on digital labelling and simplification (for
CLP, fertilisers and detergents) should be spelled out.
3
REACH Competent authorities, available at:
https://ec.europa.eu/environment/chemicals/reach/competent_authorities_en.htm
57
Problem definition
The report should provide robust evidence showing that consumers demand more
comprehensive chemical information and, as there is incomplete information, this impacts their
consumer behaviour (as stated in the intervention logic).
Policy options
The baseline should not be presented as a policy option and should be seen as dynamic
evolution of the current situation. It could, for example, already include possible non-regulatory
measures, currently conceived as option 2. The baseline should cover all existing and proposed
legislation at the time of finalising the impact assessment.
Options should bring out clearly what choices have to be made and what alternatives are
available.
The currently presented option 3 may need to be unbundled. Options can be designed per
problem area and integrated in packages which can contain regulatory and non-regulatory
measures. Options should address all problems identified.
The simplification and burden reduction potential should be thoroughly assessed, given the
REFIT nature of the initiative.
Analysis and impacts
The impact analysis should assess unavoidable impacts (costs and benefits) on downstream
legislation following the proposed changes in the CLP. If discretion is possible in the revision
of downstream legislation, this should be clearly indicated.
The report should assess how the changes in the CLP legislation will impact industry and sales
and if this will lead to less or more use of hazardous substances. How will the success look
like? (a decrease in demand for products with high health and environmental hazard?)
The impact of changing a label on consumer behaviour should be assessed.
The impact on international competitiveness should be assessed, in particular when EU rules
deviate from internationally agreed standards. When international standards are followed, this
should be justified.
Specific attention should be drawn on impacts for SMEs and possible ways to mitigate these
impacts.
The administrative burden should be analysed quantitatively with a view to the one-in-one-
out approach.
All suggestions above from the RSB were taken into account when developing this Staff
Working Document.
Table 1 below provides an overview of the RSB suggestions at the Upstream meeting and
how they have been addressed.
Table 1: Overview of the RSB suggestions and follow-up
58
RSB suggestions on draft IA Follow-up of RSB suggestions in the IA
Distinguish with CSS and provide robust
evidence
Envisaged measures were impact assessed
and preferred option determined on that basis
Description of interrelationship with
upstream and downstream legislation
See Annex 5
Correlation with other legislative initiatives
(REACH, digital services, digital
labelling…)
See point 5.1.4., further detailed in Annex 5
and in Annex 8 (REACH), Annex 13
(digital labelling) and Annex 15 (on-line
sales)
Consumer demand more information and
this impacts their behaviour
There are no measures proposed which are
expected to increase the level of consumer
information compared to the current legal
text; However desk research performed on
the scope of CLP did not identify a possible
impact from CLP on consumer behaviour.
Therefore this problem will not be
addressed by this assessment.
Baseline should not include policy option We have taken care of describing a dynamic
baseline (Section 5 and Annex 7)
Options to be clear on choices made and
available alternatives
Where alternatives were available and not
pursued, these have been clearly motivated
Option 3 should be unbundled - options can
be designed per area and integrated in
packages
Policy options were unbundled and packed
again – See intervention logic
Options should address all problems
identified
See new version of the intervention logic
Simplification and burden reduction
potential (REFIT initiative)
See section 8.2
Unavoidable impacts (cost/benefits) on
downstream legislation + indication if
discretion is possible in revision of
downstream legislation
See chapter 6 and 7 and Annex 8 and 10
Impact on industry and sales – less or more
use of hazardous substances
Impacts on industry have been assessed in
all annexes– the impact on use of hazardous
substances has been assessed in Annex 8
and 10. Direct administrative costs,
adjustment costs and impact on trade are
reported in sections 6 and 7.
Impact of changing a label on consumer
behaviour
This is covered by the study on digital
labelling, which is reported in Annex 13, as
well as Annexes 2 and 4.
International competitiveness impact to be
assessed (when international standards are
deviated from)
See Chapter 6.1.1 and Annex 8
In case international standards are followed
this should be justified
This is the case for ED criteria which have
be designed using WHO standards. This is
59
also the case for the starting point on digital
labelling. Elements required by the GHS on
a physical label would not be moved to a
digital one.
Impacts on SMEs and ways to mitigate them The impacts on SMEs have been assessed –
mitigating measures in case of increased
burden will consist essentially in additional
support, which could be implemented in the
framework of EU SME tools developed
within DG GROW and support by ECHA
Quantitative analysis of administrative
burden (one-in-one-out-approach)
Impact on administrative burden for industry
and authorities has been assessed.
Following the RSB opinion on 11 May 2022, DG ENV and GROW updated this SWD in the
following areas:
Table 2: Overview of the RSB comments and follow-up
RSB suggestions on the SWD Follow-up of RSB suggestions in the
revised SWD
(1) The analysis of the costs and benefits
should be presented in a clear and transparent
manner. The totals, bringing together all
quantified costs and benefits, should be set
out in the report in present values and
annualised. The figures in the annexes and
the main report should be clearly referenced
and coherent with each other. The report
should be clearer on the methodology of the
cost benefit analysis including explaining
why the 20-year appraisal period was chosen.
The revised SWD now contains more
information about how the costs and benefits
break down (see e.g. Table 10 in section
6.1.1.1). Each section under section 6 holds a
table with a grand total per policy option.
Annexes now report clearer quantifications
of both costs and benefits, where impacts can
be quantified (see, e.g., section on economic
impacts of policy measure 1a, p. 175 Annex
8).
When it comes to benefits, we now provide
various calculations to frame the possible
positive impacts on human health and on the
environment (see pages 175 to 199 Annex 8
and more specifically tables 69 and 70). This
order of scale is reported in the body of this
SWD.
The justification of the 20-year appraisal
period is better developed (see section 5.1).
A new heading in annex 4 (p. 90) summarises
the general principles applied for the cost
(and savings) analysis. Specific details for
each measure or group thereof are provided
in the respective annexes (see e.g.,
(2) The report should transparently present
the distributional impacts across all affected
groups. In particular, this should cover the
overall impact on businesses including a
We updated tables 14 to 16. We now provide
the same level of information, including on
SMEs, consumers and competitiveness,
where possible.
60
separate analysis of the impacts on SMEs.
The report should clarify the expected impact
of labelling on consumer behaviour. It should
also provide more detail on the impact on the
competitiveness of EU businesses. A
dedicated section of the administrative costs
and savings in scope of the ‘one in, one out’
approach should be further clarified. It
should differentiate between one-off and
recurrent costs and cost savings and the
figures should be recalculated to eliminate
the mistakes.
Since the study could not be extended to fully
cover consumer behaviour, we can only
report guestestimate on the impact on the
consumer behaviour. This is clarified in
section 6.2.2.
The section on OIOO has been revised,
developed and checked. The period of
analysis is clarified and justified. Annex 3
reports the analysis developed for the OIOO
calculator for both 10 years and 20 years.
(3) The report should explain why it is not
possible to quantify the expected significant
health and environment benefits. Even if
causality cannot be demonstrated, the report
should provide qualitative evidence that the
exposure of users and of the environment to
the identified hazardous substances will
decrease as a result of this initiative. The
report should provide a robust qualitative
analysis of the expected benefits, including
an indication of the order of magnitude of
these benefits, to justify the conclusion that
the benefits outweigh the costs for this
initiative.
See changes implemented for comment (1)
above.
When it comes to benefits, we now provide
various calculations to frame the possible
positive impacts on human health and on the
environment (see pages 175 to 187 Annex 8
and more specifically tables 69 and 70). This
order of scale is reported in the body of this
SWD.
(4) The report should make greater use of the
cost-benefit analysis, both quantitative and
qualitative, and strengthen the justification of
the preferred option.
See changes introduced to address comment
(1) as well.
(5) The report should clearly describe the
links and overlaps of the CLP Regulation
with other chemical legislation, notably
REACH, articulate its purpose and pinpoint
the remaining regulatory gaps compared to
related measures, such as the General
Product Safety Regulation, the Market
Surveillance Regulation and the Digital
Services Act.
Improved link and references between
sections 7 and 8.
Figure 1 deleted and Figure 2 updated in
Section 1 of the SWD. Section 5.1.4
describes in more details the on-going
changes and how they cover or not CLP-
related issues. Clarification is brought in
Annex 5.
Some more technical comments have been
sent directly to the author DGs.
The report was improved according to the
comments received.
EVIDENCE, SOURCES AND QUALITY
Two studies were contracted to update, confirm and gather more information on the findings
of the two Fitness Checks published in 2019 and 2020. For more information, see annex 6.
61
CLP revision study
The Commission was assisted by an external contractor through a service contract on specific
aspects of the CLP revision,4
both for the data collection and the analysis phase of the different
policy options in the impact assessment.
The tasks of the contractor were the following:
Provide support in defining the problems (including the scale of the problems and scope
of those affected, the subsidiarity and the EU dimension) that the revision of CLP
intends to solve, and the intervention logic of the impact assessment.
Refine the baseline and further develop the policy options.
Compile information from previous and ongoing studies.
Process and analyse the outcome of the open public consultation.
Conduct targeted consultations with representatives from Small and Medium sized
Enterprises, retailers/importers and other sectors of the chemical industry.
Analyse the impact of the refined options taking into account solutions identified from
the consultation strategies.
Draft a synopsis report of all consultation activities.
The contractor participated in the ISSG meetings that were held after the signature of the
contract as well as in the CARACAL meetings. In addition, the contractor worked in close
cooperation with the Commission throughout the different phases, particularly in the latter
stages of assembling a coherent evidence base and in assessing and adjusting policy options.
On this basis, evidence was compiled by the contractor for the seven potential intervention
areas: new hazard classes (hazard identification); toxicity reference values and harmonised
classification and labelling; self-classification; labelling; CLP scope exemptions; online sales
of chemicals; poison centres.
For two of these areas – new hazard classes (hazard identification) and CLP scope exemptions
– extensive supporting studies were carried out. These supporting studies used the following
methods: rapid literature review methodology (also known as rapid evidence assessment) for
data collection and interpretation, legislative document analysis (for the CLP scope
exemptions) and data analysis (for the new hazard classes).
Evidence was also collected from the various consultation activities, by means of the following
methods: questionnaire survey, for the general public and experts, including the main
stakeholders; semi-structured interviews with civil society associations, public authorities,
academia, and business entities and associations; as well as observation and document analysis
for collecting the opinions of CARACAL and its sub-group members and observers.
Annex 4 provides detailed descriptions of the methodology used for the collection and analysis
of the evidence. Moreover, detailed information regarding the evidence compiled by the
external contractor, is given in the respective Annexes that address the respective intervention
areas.
4
Service contract “Technical and Scientific Support to the Commission’s Impact Assessment for the revision of
the Regulation on Classification, Labelling and Packaging of substances and mixtures”, under the framework
contract No. ENV.B.2/FRA/2020/0010 (group led by RPA Europe S.R.L.), “Scientific and technical assistance
for the implementation of chemicals legislations on REACH, CLP, PIC and POPs”.
62
Digital labelling study
Regarding digital labelling, the Commission launched a different contract than the service
contract mentioned above on the “simplification of labelling and the use of IT tools to
communicate hazard and safety information on chemicals as well as use instructions to
consumers”5
.
This led to the initiative on “simplification and digitalisation of labelling requirements” with
an inception impact assessment commenting period lasting from 14 July to 20 September 2021
and the open public consultation from 24 November 2021 to 17 February 20226
.
CLP relevant parts of this initiative are part of this impact assessment.
In addition to the evidence gathering above mentioned for the CLP revision study (stakeholders
surveys etc.), the study on simplification and digitalisation of labelling requirements included
a behavioural experiment (see Annex 4 – Analytical Methods, Part VI).
Annex 4 provides detailed descriptions of the methodology used for the collection and analysis
of the evidence. Moreover, detailed information regarding the evidence compiled by the
external contractor is given in the respective Annexes that address the respective intervention
areas.
5
https://ted.europa.eu/udl?uri=TED:NOTICE:363150-2019:PDF:EN:HTML
6
Chemicals – simplification and digitalisation of labelling requirements (europa.eu)
63
Annex 2 – Stakeholder consultation (Synopsis
report)
The synopsis report summarises the results of all consultation activities (open public
consultation, targeted stakeholder consultation, interviews and workshops) conducted as part
of ‘Technical and Scientific Support to the Commission’s Impact Assessment for the Revision
of the Regulation on Classification, Labelling and Packaging of Substances and Mixtures
(CLP)’ on the one hand and of ‘Impact Assessment Study on the Simplification of the Labelling
Requirements for Chemicals and the Use of e-Labelling’ on the other hand. The aim is twofold:
To inform policymaking on the outcome of all consultation activities;
To inform stakeholders on how their input was taken into account.
As this impact assessment also relies on another initiative on digital labelling of chemicals,
including detergents, a separate consultation with its own strategy has been conducted and is
included in this annex.
OUTLINE OF THE CONSULTATION STRATEGY
The aim of the consultation activities was to gather stakeholder opinions on the revision of the
CLP, and to ensure that stakeholders’ views, practical experience and data were considered in
the policy development process, ensuring higher quality and balanced analysis of arguments
from different sources, and greater transparency for the policy development process.
Information was sought in relation to seven intervention areas. The consultation activities
covered the following intervention areas:
Hazard identification.
Toxicity reference values and harmonised classification and labelling.
Self-classification.
Labelling.
Digital labelling.
CLP scope exemptions.
Online sales of chemicals.
Poison centres.
For each area, the study team collected opinions about the nature of problems in an area,
possible measures to tackle the problem, impacts of measures to various target audiences,
benefits and costs of the measures.
The information collected on the respondents’ profile included stakeholder type, geographical
location, organisation size, level of knowledge of the Regulation.
In the case of the open public consultations (OPC), different questions were provided for
experts and non-experts, to ensure that the questions were appropriately targeted to the
different audiences. In the case of the targeted stakeholder surveys (TSS), question logic was
applied to ensure that questions displayed were relevant to the given stakeholder group. The
interview templates were developed to complement, validate and enrich data collected
through quantitative surveys. Finally, the behavioural experiment investigated consumers’
understanding of chemical and detergents labels, the importance of different label elements as
64
well as their interpretation with respect to safe use. Furthermore, the experiment tested
potentials ways to simplify labels and whether the introduction of digital tools could support
consumers.
Table 2 below summarises the consultation tools and strategies applied by stakeholder group.
Table 2: Consultation tools and strategies applied for by stakeholder groups
Stakeholder group Consultation tools and strategies applied
General public/consumers OPC, behavioural experiment, online survey
Representatives of the
Commission and EU agencies (e.g.,
European Medicines Agency, European
Food Safety Authority, etc.),
relevant EU committees (e.g., CARACAL
and its CASG sub-committee), experts
(e.g., academic institutions, CARACAL
observers, etc.)
Targeted consultation, in-depth interviews
and ad-hoc consultation, online surveys
Relevant Member State Authorities
OPC, targeted consultation, follow-up
interviews, online surveys
Representatives of EU industry
associations/CLP consortia
OPC, targeted consultation, interviews,
online surveys
EU and national-level worker
representative groups/trade unions
OPC, targeted consultation, interviews,
online surveys
Interested NGOs/environmental charities
and consumer associations,
academics/experts
OPC, targeted consultation, interviews,
online surveys
Consultation activities
The planning of the consultation activities was informed by the general principles and
minimum standards for consultation of interested parties by the Commission.7
The OPC on CLP was open for 14 weeks from 9 August 2021 to 15 November 2021. The
OPC questionnaire was prepared by the Commission and distributed using the EU Have Your
Say portal. The aim of the OPC was to gather opinions on the revision of the CLP Regulation
from a broad range of stakeholders. The OPC was open to anyone interested in CLP e.g.; EU
(and non-EU) citizens, researchers, businesses (including small and medium-sized enterprises
(SMEs)), industry, industrial/business associations and trade bodies, governmental and non-
governmental organisations (international, European, national and local), as well as social
partners and actors. Respondents were able to provide a response to the questionnaire on behalf
of organisations/institutions (i.e. as one of the organisations stated above), or as individuals.
Respondents registered with the EU Survey portal were able to submit additional position
papers to supplement their answers. Several additional papers were submitted via email without
providing a questionnaire response. The questionnaire was split into two sections, one
7
EC (2002): Communication from the Commission. Towards a reinforced culture of consultation and dialogue -
General principles and minimum standards for consultation of interested parties by the Commission. Brussels,
11.12.2002 COM(2002) 704 final.
65
containing 11 questions for the general public, and one containing 37 questions for experts in
the subject matter. Both sections allowed respondents to provide position papers.
The OPC on simplification and digitalization of labels on chemicals was open for 12 weeks. It
aimed to gather experiences and opinions on a possible introduction of digital labelling of many
daily used products such as glues, laundry and dishwashing detergents and fertilising products,
under CLP, the Detergents Regulation and the Fertilising Products Regulation. The findings
presented in this synopsis report and integrated in the report represents an analysis of the
responses collected on 17 February, with 205 respondents. For the purpose of this synopsis
report, only the answers to the questions related to CLP have been taken into account. The full
analysis integrating findings to the questions related to detergents products will be presented
in the next report. These answers have been divided by stakeholder categories: 141 from the
private sector (companies, business associations, trade unions), 11 from public authorities, and
53 from consumers’ representatives (48 citizens, 4 consumer association and 1 NGO).
Similarly as the interview analysis, the imbalance of representation among stakeholders groups
and their different interests has been taken into account when processing the answers.
The TSS on CLP was open for six weeks from 10 November to 22 December 2021. It was
uploaded in a questionnaire format and was distributed using Alchemer®. The aim of the TSS
was to gather opinions on the revision of the CLP from an expert audience, e.g., MSCAs
involved in the implementation and enforcement of the Regulation, duty-holders and their
representing associations, NGOs and academics active on chemical risk management and the
regulatory framework. A stakeholder mapping exercise was performed to identify key target
groups. The list included those stakeholders that provided feedback to the inception impact
assessment report, as well as key stakeholders in relevant sectors that have previously
participated in similar consultations (e.g., Consultation on the regulatory fitness of chemicals
legislation (excluding REACH)). Additional stakeholder sources included National CLP
Helpdesks, poison centres and competent authorities. The mapping exercise identified a total
of 548 stakeholders, of which 80% were companies and business associations, ten percent were
public authorities, and the remaining ten percent were stakeholders from the civil society.
Particular effort was put to identify companies and business associations, given the broad range
of sectors impacted by the Regulation. The questionnaire was split into two sections depending
on the stakeholder type: one section containing questions for companies/business associations
and civil society (all other stakeholders), and one containing questions for public authorities.
The section for companies/business associations and civil society (all other stakeholders)
contained 61 questions (36 closed and 25 open text questions) and the section for public
authorities contained 58 questions (33 closed questions and 25 open questions); both sections
allowed respondents to provide position papers.
Two online surveys, one on policy options for digitalization and for information from
professionals and industry users, were conducted. The consultation on policy options aimed at
gathering the opinion of the various stakeholders (consumers, professional and non-
professional product users, industry, civil society organisations, national authorities and any
other interested stakeholders) on the latest version of policy options analysed in this study. This
survey allowed stakeholders to provide a punctual opinion on the measures taken into
consideration for this analysis. The answers have been divided by stakeholder category: 12
Member State authorities, 1 consumer organisation, 43 industry representatives (industry
associations, businesses). The online survey for professionals and industry users collected
information from the stakeholders representing professionals and the industry on the
importance of having certain pieces of information1 on the packaging of the specific chemical
66
products8
as well as the easiness to understand the information concerning these elements in
these products.
Between September and December 2021, the Commission organised CARACAL and CASG
ad-hoc consultations on the different intervention areas, discussing problems and possible
ways forward. One-day long events were organised on:
CASG ad-hoc consultation on endocrine disruptors (13/09/2021).
CARACAL ad-hoc consultation on PMT/vPvM and PBT/vPvB (30/09/2021).
CARACAL ad-hoc consultation on Annex VIII CLP (Poison centres) and online sales
(27/10/2021).
CARACAL ad-hoc consultation on CLH prioritisation, PNEC, DNEL, DMEL,
labelling, including digital labelling (06/12/2021).
CARACAL on new hazard classes, MOCS, self-classification (14/12/2021).
It should be noted that some of the issues have been discussed by CARACAL for a number of
years (e.g., criteria on endocrine disruptors). The study team observed the discussions during
each meeting and reviewed all written feedback provided by CARACAL and CASG members
to get a more comprehensive understanding of the problems, their drivers as well as possible
measures to tackle the problems and their impacts. The study team followed up with some of
the CARACAL members through semi-structured interviews.
Twenty-two interviews were conducted between December 2021 and February 2022. The aim
was to complement the findings of the TSS and OPC and the views provided by CARACAL
members and observers. Interviews were targeted to representatives from a sufficiently diverse
group of stakeholders, while also eliciting participation from those stakeholder categories
underrepresented in OPC and TSS responses.
METHODOLOGIES AND TOOLS TO PROCESS DATA
The OPC and TSS surveys were designed and launched via online survey tools (EUSurvey
for the OPC and Alchemer for the TSS). These online survey tools enable surveys to be
distributed and read widely online (including via smartphones), offer a variety of question types
and ensures flexible access by allowing participants to save their contribution as a draft and
continue at a later date. The accessibility mode was also activated on EUSurvey to enable the
format to be adapted for the visually impaired. Results were downloaded in Excel spreadsheets,
and then added to an analytical master spreadsheet to create statistical summaries (via tables
and graphs) of the responses received. The statistical summaries were anonymised and
aggregated per stakeholder group and Member State.
All data were checked for campaigns prior to analysis to prevent the overall results being
skewed to a particular interest group. The study team used the qualitative data analysis software
NVivo® to calculate the level of similarity between the responses (by assessing the Jaccard
correlation of word similarity to produce coefficients between responses) and to ensure a
systematic approach to identifying campaigns. Where text was identified as having a high level
of correlation (between 0.5 to 1), responses were grouped for manual review and an analysis
of the campaigns identified was provided separately for both the OPC and the TSS. The total
8
Laundry detergents; Cleaning detergents; Glues; Paints; Sealants or fillers.
67
number of identified answers had to be equal or above five percent (≥ 5%) of the total number
of responses to be considered as a campaign.
All position papers received in the OPC and the TSS were read manually; themes identified
were coded in Excel and a summary of position paper responses was provided (in an
anonymised format) for both the OPC and TSS separately. To ensure an efficient approach,
where identical papers had already been provided by respondents under the OPC, or where
themes had already been covered, these were not taken forward for analysis in the TSS.
Interviews were carried out employing virtual platforms (Ms Teams and Webex). To develop
a sufficiently diverse expert sample, the study team combined convenience and purposive
sampling. Experts were identified by analysing the answers to the consultation surveys and by
area of expertise —through the analysis of initiatives and projects, publications and
membership to expert groups. The semi-structured interview approach was applied to achieve
the maximum level of detail on each topic and get comparable results from different interviews.
For interpretation of the interviews, thematic analysis was applied. Questions were provided to
all participants in advance. All interviews were recorded, and transcripts automatically
generated by MS Teams® were cleaned and analysed thematically. The main limitation is the
limited number of interviews carried out on each intervention area, as these are complex and
cover a wide range of topics. As mitigation measure, interviewees were asked to comment on
several areas and to submit their views in writing where appropriate.
RESULTS OF CONSULTATION ACTIVITIES FOR THE CLP REVISION (EXCLUDING
DIGITAL LABELLING)
Number of respondents and respondent profiles
Open Public Consultation for the CLP
All responses were clustered according to the following broad stakeholder categories to
facilitate visualisation:
Companies – companies and business associations;
Citizens – EU and non-EU;
Public authorities; and
Civil society (all other stakeholders) consisting of academic/research institutions; consumer
organisations; environmental organisations; Non-Governmental Organisations (NGOs); trade
unions; and other.
Under the stakeholder group ‘Civil society (all other stakeholders)’, respondents were grouped
together due to the comparatively low response rates, to ensure meaningful conclusions could
be drawn from the data. A total of 625 responses to the OPC were received, most from
companies and business associations (45%), and EU and non-EU citizens (39%) (Figure 1).
68
Figure 1: Number of responses to the OPC by stakeholder categories – Total: 625
Figure 2 provides a breakdown of the 383 responses from businesses by company size. SMEs
provided almost 69% of responses.
Figure 2: Number of OPC responses from businesses by company size – Total business responses: 383
Figure 3 shows the total number of OPC responses by country. Most responses were received
from France (28%) and Germany (20%). No campaigns were identified in these Member
States.
69
Figure 3: Number of OPC responses per country (worldwide and Europe) – Total: 625
Position papers
The OPC participants uploaded 144 position papers. Of these, four were duplicates and were
therefore removed from the analysis. Subsequently, there were 140 valid position papers which
the study team reviewed manually and checked for key themes. Figure 4 shows the number of
position papers submitted by different stakeholders.
70
Figure 4: Position papers received per stakeholder group – Total: 140 valid position papers
Campaigns
The analysis of the OPC results revealed only one campaign. In total 47 responses were
identified as having high levels of similarity across their responses and were referred to as
‘Campaign 1’. Campaign 1 primarily consisted of business associations (49%) and companies
(47%). Additional members of this campaign were from academic/research institutions (2%),
and ‘other’ (2%). There were no consistencies across their countries of origin, and businesses’
responses part of Campaign 1 were provided by companies of different size: micro (21%),
small (26%), medium (9%), and large (45%). While no information on the industry sector was
collected through the questionnaire, from the screening of the organisation names, it was
possible to broadly define the campaign as originating from a business association relating to
chemical products, comprising from large chemical manufacturers to smaller formulators of
household chemical products. This cluster was identified as a complex campaign, as the
positions held in each area of interest often differed according to sectors.
Targeted Stakeholder Survey
The TSS received a total of 167 responses. Figure 5 (overleaf) shows the number of responses
to the TSS per stakeholder group and the breakdown of business responses (82) by company
size. Almost 60% (64 out of 108) of the businesses and industry associations indicated that
their primary business sector is the manufacturing of chemicals and chemical products. Over
18% (32 out of 108) were active in downstream sectors (e.g. manufacture of textiles and other
manufacturing), over 6% (7 out of 108) in upstream sectors (e.g. manufacture of coke and
refined petroleum products and manufacture of basic chemicals), and five contributions (4.6%)
came from businesses/associations which final products are exempted by CLP (manufacturing
of food products and manufacturing of basic pharmaceutical products and pharmaceutical
preparations). Three responses (2.8%) were provided by entities in retail trade and two (1.8%)
from entities in other professional, scientific and technical activities. When asked about their
activities in relation to chemical products (to understand the type of duty-holders), 43% (58 out
of 136) indicated to be active in the manufacture of chemical substances, 74% (101 out of 136)
in the manufacture of mixtures, 63% (86 out of 136) in the import of chemical substances and
mixtures, 54% (74 out of 136) in the distribution of substances and mixtures, 51% (70 out of
136) in the use of chemical products.
71
Figure 5: Number of TSS responses by stakeholder category – Total: 167 and number of TSS business
responses by company size – Total business responses: 82
Two responses were provided by national helpdesks, one from a poison centre, five from
competent authorities for the implementation of CLP, two from authorities competent for the
enforcement of CLP and one from a competent authority on workers’ health and safety. Figure
6 shows the number of responses received in response to the TSS by Member State. Eighteen
responses were received by organisations operating EU-wide and 10 responses from
organisations outside the EU. The results show a large number of responses from Germany
(33% of the total), which include a campaign of German industry associations (additional
details are provided in the subsection ‘campaigns’).
Figure 6: Number of TSS responses by country – Total: 167
72
Position papers
A total of 39 documents were uploaded in response to the TSS. Each document was reviewed
for key information. Around 30 documents were already provided during the OPC and were
therefore excluded from the analysis. The remaining 9 documents were submitted by 8 business
associations and one NGO.
Campaigns
Overall, 4 main campaigns (48 replies in total) originating from industry associations were
identified based on similarities of replies to the open text questions (using NVivo and applying
a Jaccard coefficient larger than 0.5). Three of the campaigns (A, B and C) met the criteria of
more than 5% of the total number of replies. However, one further campaign was identified
(D) with six replies and was included for transparency. Campaign A consisted of 19 replies,
and originated from European chemicals associations. Campaign B consisted of 15 replies,
and originated from German industry associations. Campaign C consisted of 8 replies
originating from European and German paint associations and companies. Campaign D
consisted of 6 replies originating from cosmetics associations and industries.
Interviews
The study team carried out 22 semi-structured interviews with experts who represented: public
authorities (5), EU agencies (2), business entities and associations (10), civil societies (3),
academic researchers (1), professional organisations (1). Nine conversations were group
interviews, while 13 – individual interviews.
CONSULTATION ACTIVITIES ON DIGITAL LABELLING OF CHEMICALS
Interviews
Firstly, the study team conducted 10 scoping interviews with EU and international experts on
labelling requirements and the use of digital tools to communicate hazard and safety
information and instructions to users. Scoping interviews help to familiarise further with the
topic and understand its main challenges. The objectives of the scoping interviews were to:
Ensure that the study team is aware of all relevant background documentation and latest
regulatory developments in the field;
Collect contact details of relevant stakeholders to be contacted during the data
collections exercises (i.e., identifying potential future interviewees);
Raise awareness among stakeholders of the study and its benefits and enlist their future
cooperation.
In a second phase, interviews were conducted with various types of stakeholders involved in
labelling requirements of chemicals and the use of digital tools to communicate hazard and
safety information and instructions to users.
The objectives of the interviews were to collect stakeholders’ feedback on different topics
related to the labelling of chemical products and e-labelling, including:
Perceived current understanding of chemical labels by different categories of users;
The usefulness and relevance of information provided currently on chemical labels;
The assessment of labelling requirements and needs of users;
73
The analysis of existing IT solutions available for e-labelling;
Identification of information that should remain on the physical label and suggestions of
information to put on an e-label for chemical products.
In total 41 interviews have been conducted with the following categories of stakeholders:
5 European and national authorities;
11 NGOs, including 8 consumer associations;
25 Business representatives (from business associations and companies).
While all categories of stakeholders targeted for this stakeholder consultation have been
reached, it must be noted that, among the respondents, a majority of them are representing the
interests of the industry. This imbalance and the interests represented by this category of
stakeholders have been taken into account in the analysis of the findings of the interviews.
Behavioural experiment
The aim of the behavioural experiment was to investigate consumers’ understanding of
chemical and detergents labels, the importance of different label elements as well as their
interpretation with respect to safe use. Furthermore, the experiment tested potentials ways to
simplify labels and whether the introduction of digital tools could support consumers.
Therefore, a state-of-the-art online experiment was designed that included six treatments, i.e.
two different products (laundry detergent and glue) as well as three different labelling options
(Status Quo Label in accordance with current regulation, Simplified Label with QR-Code and
No Label Baseline). Participants were incentivised for taking part in the study as well as for
their decisions in the different tasks. Furthermore, the treatment assignment was fully
randomised.
Although representative products and labels were used in the experimental design and
participants were tracked when consulting the labels presented on screen, it must be noted that
the experiment can only mimic reality, i.e. a situation of consulting a label in everyday life.
Main data collection was conducted in four Member States, i.e. DE, EL, FR and RO, and a
total of 4,003 consumers took a part in the study.
Participants were recruited from an actively managed online panel and quotas to reach
representativeness of the country-specific samples were used.
Open Public Consultation - Simplification and digitalisation of labels on chemicals
The findings presented in this Annex represents an analysis of the responses collected on 17
February, with 205 respondents. Only the answers to the questions related to the CLP-
regulation have been taken into account.
These answers have been divided by stakeholder categories: 141 from the private sector
(companies, business associations, trade unions), 11 from public authorities, and 53 from
consumers’ representatives (48 citizens, 4 consumer association and 1 NGO). Similarly as the
interview analysis, the imbalance of representation among stakeholders groups and their
different interests has been taken into account when processing the answers.
74
Online survey on policy option
This consultation, run by VVA, aimed at gathering the opinion of the various stakeholders
(consumers, professional and non-professional product users, industry, civil society
organisations, national authorities and any other interested stakeholders) on the latest version
of policy options analysed in this study. This survey allowed stakeholders to provide a punctual
opinion on the measures taken into consideration for this analysis.
The answers have been divided by stakeholder category: 12 Member State authorities, 1
consumer organisation, 43 industry representatives (industry associations, businesses).
Online survey for professionals and industry users
The aim of the survey was to collect information from the stakeholders representing
professionals and the industry on the importance of having certain pieces of information9
on
the packaging of the specific chemical products10
as well as the easiness to understand the
information concerning these elements in these products.
STAKEHOLDERS’ VIEWS
Area 1: Hazard identification
The OPC results show that opinions about the introduction of new hazard classes
substantially varied between different stakeholder groups:
Civil societies, public authorities and citizens were in favour of ‘a sub-categorisation for
chemicals with a high level of certainty on their endocrine-disrupting properties’, while 63%
of companies and business associations were not in favour.
Most respondents (69% overall) did not believe that a category for suspected PBT (and one for
suspected vPvB) would be needed. However, citizens were polarised in their responses (44%
yes, 56% no). Stakeholders’ views also varied regarding whether categories for suspected PMT
and vPvM would be needed: companies and business associations were mostly not in favour
(75%), while most respondents of the other stakeholder groups were in favour (civil society,
79%; citizens, 62%; and public authorities, 53%).
Of all respondents, 36% considered developing a hazard class or criteria for immunotoxicity
‘very relevant’, whilst 21% are ‘neutral’ and 16% consider it ‘somewhat relevant’. Thirty-six
percent (36%) of all respondents consider the development of a separate specific hazard class
or criteria for neurotoxicity ‘very relevant’. Companies and business associations were most
likely to consider the issue ‘very irrelevant’ (25%), while public authorities responded neutrally
or ‘somewhat relevant’.
9
Name of the product; Address and telephone number of the supplier; Instructions for use; Dosage
recommendations; Marketing information; Quantity; List of ingredients contained in the product, such as
allergens, preservatives or enzymes; Weblink to receive full ingredients list; Information relevant in case of
intoxication e.g. poison centre telephone number; UFI-code etc.; Hazard pictogram; Signal word, i.e., “Warning”
or “Danger”; Statements on the products hazards for human health environment and physical hazards; Statements
on the precautions to be taken on the use, storage and disposal of the product; Statements on how to prevent and
minimise adverse effects when accidentally exposed.
10
Laundry detergents; Cleaning detergents; Glues; Paints; Sealants or fillers.
75
TSS responses analysis confirmed that business entities and associations were, mostly, not in
favour of introducing new hazard classes. The key argumentations were that it will cause
information overload in hazard communication, distort the level playing field in international
trade and lead to an increase in costs for various activities, including hazard assessment,
classification and reclassification of substances, labelling and relabelling of substances and
mixtures, update and distribution of revised safety data sheets (SDS), packaging, reformulation
of mixtures, update of IT systems and training the staff. They also pointed to overlaps in hazard
classes and other problems in hazard class definitions, which are still premature from a
scientific point of view. In this regard, the common arguments against new hazard classes,
many of them advocated by business entities, were as follows:
 Endocrine disrupting properties of chemicals refer to a mode of action, not a hazard.
Also, properties such as persistency, mobility and similar are not necessarily related to
hazards, i.e. they do not automatically mean that a chemical is hazardous.
 The existing hazard classification in the CLP Regulation already covers the hazards of
endocrine-disrupting substances.
Consultees provided counterarguments, for instance, for treating endocrine disrupting
properties as a mode of action. They stated that EDs affect various organisms in very different
ways; therefore, one cannot speak of a single mode of action. Similarly, some
counterarguments were available in the written responses of CARACAL members on
PBT/vPvB/PMT/vPvM properties. For instance, some CARACAL members highlighted those
substances with a combination of specific properties, e.g., very persistent and very mobile or
persistent, mobile and toxic pose a threat to drinking water sources. Such combinations of
properties increase the chances of chemicals passing natural and artificial barriers in
wastewater treatment facilities.
Supporters of the introduction of new hazard classes highlighted reduced exposure to
hazardous chemicals, safer workplaces, substitution and better control of hazardous chemicals
as the key reasons for having new hazard classes in CLP. On the other side, opponents pointed
to the issues in international trade, the potential for regrettable substitutions as well as the
increased costs and burdens for businesses as the main arguments for not including new hazard
classes.
Area 2: Toxicity reference values and harmonised classification and labelling
Stakeholders’ views on harmonising toxicity reference values in the CLP Regulation ranged
from neutral to negative in the different consultation activities. With regards to the importance
of harmonising toxicity reference values (i.e., DNEL, DMEL, PNEC) under CLP, responses to
the OPC among the stakeholder types remained broadly neutral, with some variation between
companies and business associations who were more likely to respond ‘not important’, and
public authorities and citizens who were more likely to respond ‘important’. Sixty per cent of
the TSS respondents did not consider the inclusion of toxicity reference values in harmonised
classifications particularly important. Many stressed that the issue of hazard quantification,
and therefore the establishment of harmonised toxicity reference values, is out of the
scope of the CLP Regulation.
Most respondents of the OPC and TSS supported the prioritisation system in the harmonised
classification and labelling (CLH). Sixty-eight percent (68%) of the OPC respondents and 54%
of TSS respondents agreed that the CLH system should allow for the prioritisation of
substances raising high level of concern.
76
However, opinions about providing the Commission with the right to initiate CLH varied.
Forty-six per cent of the OPC respondents strongly agree with such an option, while 20% -
strongly disagree. Civil society, public authorities and citizens were more likely to strongly
agree with this statement than companies and business associations.
Strong support (89% of TSS respondents - ‘very important’/’fairly important’, except civil
societies) was expressed for the provision of the right to propose modifications to existing
CLH to manufacturers, importers and downstream users subject to specific conditions,
including priority assessment by the Commission.
Regarding the CLH process, two opposite opinions dominated: some respondents consider the
CLH process as inefficient (e.g., in terms of time, organisation of procedures, etc.); others
believe that the process is organised properly and does not require improvements. Some
interviewees noted the lack of scientific quality and fair prioritisation of substances for CLH.
Importantly, some CARACAL members highlighted that ECHA and RAC work at maximum
capacity.
Area 3: Self-classification
Consultees believe that ECHA should be able to remove incomplete, incorrect or obsolete
notifications from the Classification and Labelling Inventory (CLI) after having informed the
notifier.
Around 70% of TSS respondents stressed that it is important to improve ECHA’s digital tools
for classification and labelling notification. Seventy-two percent (72%) of respondents to the
OPC believed that the obligation to agree on a CLI entry should be strengthened.
While many respondents acknowledged that the Inventory contains obsolete information and
errors and diverging self-classifications of the same substance, they do not see these as major
problems. Some do think that the quality of the information is not good and the CLI cannot be
trusted, but these issues do not have any major impact on stakeholders.
Area 4: Labelling
Mixed views were received from respondents concerning how clear and easy to understand
chemical labels are in general. The only respondent stakeholder group to indicate that labels
are generally ‘clear/understandable’ were public authorities, with the remaining stakeholder
groups indicating somewhere between ‘unclear and hard to understand’ and
‘clear/understandable’, suggesting room for improvement.
When given the option to provide less but clearer information on labels or ‘as much information
as possible’ (making the label more difficult to read in some cases), most respondents (80%)
indicated that they would prefer less but clearer information on labels. This was true across
all the stakeholder groups, although responses from civil society were more evenly split (52%
would prefer less information, 48% would prefer as much information as possible).
A varying level of support for digital labels was expressed by OPC and TSS respondents.
Ninety-two percent (92%) of business entities and associations who responded to the TSS
welcomed digital labelling as a complementary hazard communication measure. Thirty-eight
percent (38%) of the OPC respondents chose digital labels as the best options for receiving
information on hazards and safety instructions when buying re-fill detergents. It was
77
highlighted that care must however be taken as not all product users may have access to digital
information.
With regard to the labelling of chemical products provided in small packages, companies
and business associations felt that this is beneficial only when the presence of a hazardous
substance has a realistic chance to cause actual harm to the user.
Furthermore, business entities and associations who responded to the TSS strongly
supported other labelling measures, such as derogation from labelling requirements for
substances and mixtures supplied in bulk (71% rated as ‘very important’/’fairly important’),
derogation from labelling requirements for substances and mixtures contained in very small
packaging (90% rated as ‘very important’/’fairly important’), and the use of fold-out labels to
provide information in the EU languages (76% rated as ‘very important’/’fairly important’).
In the OPC, all stakeholder groups agreed that there would be significant cost savings from
the following four policy options: exempting small products (pens, lighters) from certain
labelling requirements, allowing a wide use of multilanguage labels/fold-out labels, providing
certain obligatory labelling information digitally instead of on the label, and providing
additional information digitally. Public authorities were the most likely to suggest that
obligatory provision of information via digital labelling instead of the traditional label could
have significant negative health, safety and environmental impacts. Business entities and
associations were more likely to see some cost savings as a result of labelling derogations for
smalls products and bulk chemicals, application of digital labelling and fold-out labels, as well
as using symbols instead of multilingual texts on the label.
Interviewees consider that the lack of information through labels for re-fill chemicals as a
significant gap. The insufficient granularity of opinions was observed with regards to
chemicals sold in bulk, which were mainly treated as fuels. In the open text responses to the
TSS, businesses expressed different opinions regarding bulk chemicals. Some respondents
draw attention to the fact that hazards of chemicals sold in bulk (fuels in particular) are not
communicated, while others emphasised that fuels are sold to trained users who are well-aware
of the product and buy it repeatedly. Similar concerns were voiced by CARACAL members.
Area 5: digital labelling
Views on consumers’ understanding of chemical labels: A majority of stakeholders from
both the business sectors (22 out of 24) and consumer associations (6 out of 10) believes that,
the chemical labels as they are now, are not well understood by consumers, for a variety of
reasons. First of all, the main arguments highlighted that would explain a poor understanding
of chemical labelling by consumers rely on the fact that consumers do not spend enough time
reading the label (only a few seconds, except in case of accidents), and interpret them quickly
and intuitively. Moreover, the overloaded character of labels and the long texts in small prints
(as highlighted by all categories of stakeholders) reduce the readability and understanding of
labels. Stakeholders from all categories have also underlined the use of technical terminology
(e.g. chemical names) as an obstacle for consumers’ understanding. While stakeholders from
the business sector also argued that GHS pictograms are not well understood by consumers,
stakeholders representing national authorities and consumers associations underlined the fact
that consumers know pictograms and that they are better understood than texts.
Views on usefulness of information provided on chemical products labels in general:
During interviews, stakeholders have been asked to discuss, among the information currently
78
provided on labels, which information they found particularly important to be provided for
consumers’, and which information they deemed non-essential. Stakeholders from all
categories agreed that hazard information (notably the hazard statements) was one of the most
useful information to be conveyed to consumers. However, they also noted that in some cases
there could be an overlap or a redundancy of information given between the hazard statements
and the precautionary statements, and that this redundancy could be addressed to simplify and
optimise space on the label.
Communicating information on the safe and appropriate use of products to consumers – notably
through precautionary statements – was agreed by all stakeholders to be the most important
type of information to be communicated on chemical labels, including information related to
the safe use (e.g. purpose of product, how to use the product, and with which equipment),
information on safe storage of the products (e.g. keep away from children), and information in
case of emergency situations.
There was a consensus among stakeholders that pictograms on chemical labels are favoured
over texts. On the other hand, a couple of stakeholders from the industry and national
authorities raised doubts about consumers’ understanding of GHS pictograms. Nonetheless,
several consumer associations pointed out that their usefulness also lies in the fact that they are
important for catching the consumers’ attention and prompt them to read the hazard statement.
The presence of the recently added UFI code was also deemed useful to be communicated on
chemical labels.
Perspectives on multilingual labels: Business representatives explained that multilingual
labels are used to achieve economies of scale, and one business association also mentioned e-
commerce which must accommodate the needs of consumers coming from a wide range of
countries. According to businesses and business associations multilingual labels allow the
industry to produce one label for several countries, which is particularly useful when businesses
have to distribute a product in countries with a low population and different languages. They
also mention that scale through multilingual packs saves money and materials, allows a bigger
flexibility in planning, and reduces scrapping. The business sector further explained that if
companies had to produce quantities of products separately for all markets, the exercise would
be so complex that companies might abandon smaller markets, thus depriving consumers from
future innovations. The business sector explained that the simplification of labels, in other
words the optimisation of labels with less information provided on pack was essential in their
opinion.
On the other hand, national authorities explained that featuring multiple languages makes labels
hard to read at the expense of communicating important safety and hazard information. In their
view reducing languages on the label would allow more room for presenting essential
information in a clear and legible manner. Consumer associations had similar views in this
regard, highlighting also that the purpose of multi-lingual labels would be to meet consumers’
needs in the specific countries, and proposing to add additional languages only if there is
adequate space left on the label after essential information for safety and hazard was included
in a readable manner in the official language(s) required.
Feedback on the potential use of IT tools for chemical labelling: The perceived readiness
of consumers to use digital tools to access information on chemicals was very heterogeneous
among stakeholders. The majority of stakeholders from the industry argued that consumers
seem ready now to use IT tools to access information on a digital environment. To this regard,
79
they pointed out the high awareness of QR codes (especially since the COVID-19 crisis and
the increase in their use in day-to-day activities to limit physical contact).
On the other hand, several stakeholders from all categories have argued that consumers were
not ready to shift their habits and use IT tools in their day-to-day lives when it comes to buying
and using chemical products. First of all, they have pointed out that consumers’ readiness can
vary widely depending on age groups (young people being more ready than older consumers),
on country, education, and training. Moreover, several other issues have been highlighted, such
as the lack of internet coverage in some geographical areas, the fact that not every consumer
owns a smartphone or has an easy access to internet at home, as well as the need to educate
consumers at national level about the possibilities to access information digitally and benefit
from the presence of e-labels.
Overall, the behavioural experiment shows that the Status Quo and Simplified Label with QR-
code perform better than the No Label Baseline w.r.t. labelling understanding. Furthermore,
the Status Quo and Simplified Label perform equally well. Although, it must be noted that
average understanding of labels is generally not good. Subjective risk interpretation of the
Status Quo and Simplified Label is in line with the actual dangers of products. Furthermore,
subjective ratings of understandability and ease to find of label elements are not different
between the Status Quo and Simplified Label.
The majority of the respondents11
indicated that, in the context of the below chemical products,
removing some of the information from the on-pack label to the digital labels would have a
moderately positive or a very positive effect overall:
11
125 out of 180 respondents who have answered to a part on the other chemical products such as glues, lamp
oils, paints, solvents, etc., 112 out of 165 respondents who have answered to a part on the detergents, and 103 out
of 153 respondents who have answered to a part on the fertilising products.
80
Table 3: Analysis of replies on effect of removing some of the information from the on-pack label to the digital
labels
Respondents: N = 153 for Fertilising Product, N= 165 for Detergents, and N = 180 for other chemicals.
The majority of the respondents, including consumer representatives12
indicated that
information should remain on the on-pack label (for a chemical product such as a glue,
lamp oil, paint, solvent, etc.) concerning the: identification code for poison centers13
; hazard
statement or signal word14
; and pictogram showing the risk15
.
In regards to the other sources of information, the respondents (including consumer
representatives) had different views on what kind of information could move to a digital label.
The full overview of the responses to this question is provided in the table below:
Table 4: Replies of the information to be moved to a digital label
Area 6: CLP scope exemptions
A large group of the OPC respondents (43%-49%), consisting mostly of citizens, public
authorities and civil societies felt that the provision of information on the environmental
hazards of veterinary medicines, medical devices, cosmetics, and food or feed, was ‘an
12
39 out of 50 answers for “pictogram showing the risk”; 35 out of 49 answers for hazard statement or signal
word”; and 31 out of 50 answers for identification code for poison centres”.
13
106 out of 158 total responses.
14
109 out of 156 total responses.
15
121 out of 157 total responses.
12%
13%
12%
12%
10%
10%
21%
26%
27%
46%
42%
43%
0% 25% 50% 75% 100%
Fertilising Products
Detergents
Other chemical products such as glues,
lamp oils, paints, solvents, etc.
Very negatively Moderately negatively
Neither positively nor negatively Moderately positively
Very positively Other
77%
70%
36%
30%
34%
67%
22%
26%
48%
37%
33%
19%
1%
4%
16%
33%
34%
14%
0% 25% 50% 75% 100%
Pictogram showing the risk
Hazard statement or signal word
Precautionary statements on how to store,…
The name of the chemicals causing the hazard
Additional specific labelling information
Identification code for poison centers
All information should remain on the on-pack label
Basic information should be kept on the on-pack label and more details provided via a digital label
Information should move to a digital label
81
issue which should be immediately solved’. Differently from other respondents, business
entities and associations felt that there is an issue to be immediately solved only for human
medicines (53% of business respondents), while for other exempted products there is no issue
at all.
Opinions on the regulatory gaps in addressing the environmental hazards borne by the
products exempted from the CLP Regulation gathered through the TSS vary. Business
entities and associations (60%-66%) are of the view that the environmental hazards of the
exempted products are properly covered by sectorial legislation. Public authorities believed
that the environmental hazards are insufficiently addressed by the sectorial legislation
regulating human and medicinal products, as well as medical devices, but they considered that
the sectorial legislation adequately addresses the environmental hazards of cosmetics, food and
feed products. It should be noted that a very low number of public authorities and NGOs
participated in the TSS to confidently judge the predominant view within these groups.
Many interviewees commented that the measures to address the potential environmental
hazards of the exempted products are in place, although they are risk-based rather than
hazard-based.
Area 7: Online sales of chemicals
The findings of consultation activities show that all stakeholders agree that online sales of
chemicals pose challenges and problems. In the OPC, the overwhelming majority of
respondents (93%, with agreement across all stakeholder groups) believed that there is a great
need to apply the same CLP obligations (e.g., labelling, classification and notifications to
poison centres) to chemical products sold online. In the TSS, all groups of stakeholders
‘agreed’ (average answer in all groups – 4 ‘agree’) that the current gaps in the CLP Regulation
considering online sales hinders its ability to protect human health and the environment and its
ability to ensure the free movement of chemicals.
Interviewees indicated that non-compliance of online sales of chemicals with classification
and labelling as well as CLP Article 48 requirements is a problem, pointing in particular to
non-EU traders and small business entities engaged in e-commerce.
Area 8: Poison centres
Most responses were not descriptions of the problem as perceived by the respondents, but rather
reactions to potential actions or measures that the respondents foresaw (e.g., the lack of
information in poison centres was equated with actions on increasing the clarity of Article 45
of the CLP Regulation).
The analysis of open-text responses and position papers in the OPC allows us to conclude
that the problem of ambiguous obligations in Article 45 was recognised by the stakeholders, as
most of them welcomed the clarification of obligations. However, most OPC respondents
(67%) think that it is ‘not useful’ to submit poison centres notifications on substances.
Some TSS respondents believed that the problem is in the diverging interpretation of Article
45 by the Member States leading to specific national requirements. In case of introducing
notification obligation for distributors in Article 45 and notification obligation for substances,
business entities and associations felt that their costs of updating IT systems and training
the staff might increase.
82
83
Annex 3 – Who is affected and how?
1 PRACTICAL IMPLICATIONS OF THE INITIATIVE
Classification of chemical hazards
First on new hazard classes, industry will be required to review the data available for the
substances and mixtures they placed on the market. They should identify, classify, notify and
label their ED, PBT, vPvB, PMT, vPvM substances and mixtures. Some companies would
phase out the identified substances in their portfolio and/or as ingredients of their chemical
products. The exposure of users and of the environment to the identified hazardous substances
will decrease, thanks to adequate hazard information communicated to the users of chemicals
and by voluntary reformulation from some companies.
Second, the changes introduced to improve self-classifications will request companies to
swiftly update their self-classification once new data is identified. They should also justify their
self-classification when diverging from existing ones. They should also submit confidentiality
requests to ECHA when publishing their names would disclose business confidential
information. They would then update their notification to ECHA’s Inventory, where
appropriate. An inventory where information is easier to access will save time and foster
accurate (mixtures) self-classification. ECHA would need to check the confidentiality requests
as well as whether updates have been performed within the required timeline.
Third, more harmonised classifications will focus on substances with carcinogenic, mutagenic,
toxic to reproduction, endocrine disrupting, PBT, vPvB, PMT and/or vPvM properties.
Companies should update their classifications, notifications and relabel their substances and
mixtures, where appropriate. Some companies may phase out the identified substances in their
portfolio and/or as ingredients of their chemical products. When it comes to carcinogenic,
mutagenic, reprotoxic substances, current risk mitigation measures laid down in REACH or
sectorial regulations would apply. The exposure of users and of the environment to the
identified hazardous substances will decrease, thanks to adequate hazard information
communicated to the users of chemicals and by voluntary or compulsory reformulation from
some companies. ECHA, Member States, maybe with the help of consultant, would develop
more dossiers for ECHA to assess. It is not clear how ECHA would deliver on this increased
stream of dossiers.
Communication of chemical hazards
Companies would have to update their label and relabel their products where necessary. With
the use of fold-out labels, companies could access the market of multiple Member States.
Companies placing on the market fuels in bulk or chemicals in very small packaging will gain
certainty on alternatives to physical labels for hazard communication. Retailers will need to
adapt their refill stations and chemical portfolio for refill sales. Duty-holders may take the
opportunity to digitalise part of their labelling.
Closing gaps and ambiguities
Companies placing chemicals on the EU market without an economic actor established in the
EU will need to authorise a representative or contract a fulfilment service provider. Distributors
84
(including re-branders and relabellers) would notify their self-classification of mixtures to
poison centres.
2 SUMMARY OF COSTS AND BENEFITS
The tables below present the overview of the costs and benefits identified for the preferred
option. These figures are estimates, based on the sometimes limited data available. In sub-
sections I and II, figures are drawn up against a period of 20y as some benefits may only arise
in more than one generation.
The One-In-One-Out analysis is presented in tables III and IV. The figures for one-off costs
are not annualised.
I. Overview of Benefits (total for all provisions) – Preferred Option – 20y basis
Description Amount Comments
Direct benefits
Labelling Reduction Costs €9.91 million
Annual or annualised savings for
businesses (fuels and chemicals in very
small packaging, including pens).
Labelling Reduction Costs €39.50 million
Annual savings for businesses (fold-out
labels).
Reduced ED sickness and
negative impacts on the
environment
It is not possible to precisely quantify the
benefits. However indicative calculations
are provided in Annex 8, pages 186 to 199.
Potential savings are in the same order of
magnitude as the costs. They could be
higher than the costs.
Indirect benefits
Easier navigation in the
Classification and Labelling
Inventory
€8.94 million
Annual savings for businesses (cost saving
of navigating the CLI).
Reduced compliance checks
by market surveillance
authorities
€0.29 million Reduced enforcement costs.
(1) Estimates are gross values relative to the baseline for the preferred option as a whole (i.e. the impact of
individual actions/obligations of the preferred option are aggregated together); (2) Please indicate which
stakeholder group is the main recipient of the benefit in the comment section;(3) For reductions in regulatory
costs, please describe details as to how the saving arises (e.g. reductions in adjustment costs, administrative
costs, regulatory charges, enforcement costs, etc.;); (4) Cost savings related to the ’one in, one out’ approach
are detailed in Tool #58 and #59 of the ‘better regulation’ toolbox. * indirect benefits are excluded
85
II. Overview of costs (in €) – Preferred option – annualised according to 20y basis
Citizens/Consumers Businesses Administrations
One-
off
Recurrent One-off Recurrent One-off Recurrent
Classification
of chemical
hazards
PO1a, PO1b
(with
measure #5)
and PO1c
(with
measure #8)
Direct adjustment costs - - 26.40 million - - -
Indirect adjustment
costs
- - - - - -
Direct administrative
costs
- - 12.89 million 3.85 million 0.91million -
Direct regulatory fees
and charges
- - - - - -
Direct enforcement
costs
- - - - - -
Indirect costs - - 7.76 million 1.29 million - -
Hazard
labelling
Direct adjustment costs - -
None
quantified
- - -
Direct administrative
costs
- - 0.06 million 1.64 million - -
Direct regulatory fees
and charges
- - - - - -
Direct enforcement
costs
- - - - - 0.1 million
Indirect costs - 8.61 million - 0.03 million - -
Poison
centres
Online Sale
Direct adjustment costs - - - - - -
Direct administrative
costs
- - - 0.4 million - -
Direct regulatory fees
and charges
- - - - - -
Direct enforcement
costs
- - - - - -
Indirect costs - - - - - -
(1) Estimates (gross values) to be provided with respect to the baseline; (2) costs are provided for each identifiable
action/obligation of the preferred option otherwise for all retained options when no preferred option is specified;
(3) If relevant and available, please present information on costs according to the standard typology of costs
(adjustment costs, administrative costs, regulatory charges, enforcement costs, indirect costs;). (4)
Administrative costs for offsetting as explained in Tool #58 and #59 of the ‘better regulation’ toolbox. The total
adjustment costs should equal the sum of the adjustment costs presented in the upper part of the table
(whenever they are quantifiable and/or can be monetised). Measures taken with a view to compensate
adjustment costs to the greatest extent possible are presented in the section of the impact assessment report
presenting the preferred option.
86
III. Overview of Benefits (total for all provisions) – Preferred Option
Description Amount Comments
Direct benefits
Administrative cost savings related to the ‘one in, one out’ approach*
Costs associated with
changes to labelling and
packaging.
57.4 million EURO per annum Savings in recurrent administrative costs on
businesses
Costs associated with
changes to labelling and
packaging.
13.5 million EURO (one-off) One-off administrative cost savings for
business related to labelling
IV. Overview of costs – Preferred option (million EURO)
Citizens/Consumers Businesses Administrations
One-off Recurrent One-off Recurrent One-off Recurrent
Costs related to the ‘one in, one out’ approach
Administrative costs 0.0 8.6 258.7 23.2
The preferred option would create net savings in recurrent administrative costs on businesses and
citizens of 25.6 million EURO per annum. The preferred option would however impose net (total) one-
off administrative costs on businesses and citizens of 245.2 million EURO.
87
3 RELEVANT SUSTAINABLE DEVELOPMENT GOALS
V. Overview of relevant Sustainable Development Goals – Preferred Option(s)
Relevant SDG Expected progress towards the Goal Comments
SDG #3 Good health and
well-being
Reduction of exposure of humans and the
environment to hazardous substances as
meeting one of the existing hazard classes
(improvement of self and harmonised
classifications) or new ones for EDs and
PMT, vPvM, PBT and vPvB substances.
Around 2,250 substances may be identified
by 2030. Furthermore, between 2,200 and
14,000 mixtures may be voluntarily
reformulated to remove substances newly
identified as hazardous over the same period.
Specific Target 3.9 ‘By 2030,
substantially reduce the number of
deaths and illnesses from hazardous
chemicals and air, water and soil
pollution and contamination’
SDG #6 Clean water and
sanitation
Identification of PMT and vPvM substances,
which are difficult to remove from waste
waters will help to reducing the pollution of
water bodies. By 2030, 35 substances may
be identified as PMT or vPvM substances.
Up to 220 mixtures may be voluntarily
reformulated to remove the newly hazardous
substances
Specific Target 6.3 ‘By 2030, improve
water quality by reducing pollution,
eliminating dumping and minimising
release of hazardous chemicals and
materials, halving the proportion of
untreated wastewater and substantially
increasing recycling and safe reuse
globally’
SDG #9 Industry,
innovation and
infrastructure
Setting criteria to identify hazardous
substances and improving both the self and
harmonised classification processes will
allow the European chemical industry to
transition to more sustainable and future-
proofed chemicals. Voluntary substitutions
of substances classified as hazardous as such
or in mixtures will also foster innovation in
the chemical industry. Measures to improve
classification processes are expected to
contribute to SDG #3, #6 and 12, albeit
indirectly.
Specific Target 9.4 ‘By 2030, upgrade
infrastructure and retrofit industries to
make them sustainable, with increased
resource-use efficiency and greater
adoption of clean and environmentally
sound technologies and industrial
processes, with all countries taking
action in accordance with their
respective capabilities’
SDG #12 Ensure
sustainable consumption
and production patterns
Information on chemical hazards will be
improved so consumers and users of
chemical can not only protect themselves
better but also make informed choices. Self-
refill chemicals will be better regulated to
allow only refill of mildly hazardous
substances. When it comes to online sales of
chemicals, customers will have access to
more comprehensive information on
chemical hazards. Voluntary substitution of
hazardous substances in mixtures will also
help producing more sustainable chemical
products.
Specific Target 12.4 ‘By 2020, achieve
the environmentally sound management
of chemicals and all wastes throughout
their life cycle, in accordance with
agreed international frameworks, and
significantly reduce their release to air,
water and soil in order to minimise their
adverse impacts on human health and
the environment’
88
Annex 4 – Analytical Methods
This Annex reports the following methodologies used in this SWD.
 Methodology developed by ECHA to screen registered substances meeting specific
hazard criteria;
 Methodology used for the behavioural study;
 Methodology to derive quantified administrative costs and savings.
OVERVIEW
The research carried out by the project teams follows the Better Regulation Policy Guidelines
for the impact assessment and uses various methods to collect and analyse evidence necessary
for the impact assessment of the CLP Regulation. Figure 7 summarises how project research
tasks supporting the development of the impact assessment report in line with Better Regulation
requirements.
Figure 7: Overview of the tasks supporting the impact assessment study
89
Project tasks 1 and 5 support the implementation of the project, while the research programme
of the study is implemented in tasks 2, 3 and 4. Analytical methods used for completing the
latter tasks will be overviewed in the following sections.
EVIDENCE COLLECTION METHODS
Evidence gathering (Task 2) aimed to collect, analyse and evaluate the available evidence that
is relevant for the impact assessment of the CLP Regulation, in particular, for developing
problem definitions, policy options, assessment of the impact of these as well as developing
questions for open public consultation. Evidence collection covered the seven problem areas
defined in the Terms of Reference for this study:
1 new hazard classes (hazard identification);
2 toxicity reference values and harmonised classification and labelling;
3 self-classification;
4 labelling;
5 CLP scope exemption;
6 online sales of chemicals;
7 poison centres.
A rapid literature review methodology (also known as rapid evidence assessment – REA)
was used for data collection and interpretation. Rapid reviews are widely used for the analysis
of the broad spectrum of topics or issues, which is the case of this study. They are based on the
main principles of systematic literature reviews, which contributes to their robustness;
however, rapid reviews do not develop sophisticated methodologies for evidence weighting
and inclusion as well as for quantitative analysis designs for the presentation of findings. The
absence of extensive and complex research methodologies substantially reduce time needed to
conduct a literature review. Rapid reviews give comprehensive qualitative narrative overviews
of the selected domain. Collection and evaluation of robustness of evidence followed Better
Regulation Tool #4.
For two problem areas – new hazard classes (hazard identification) and CLP scope exemptions,
extensive supporting studies were carried out. In addition to rapid literature review these
studies used other method – legislative document analysis (CLP scope exemptions) and data
analysis (new hazard classes).
CONSULTATION METHODS
Consultation activities (Task 3) ensured that stakeholders’ views, practical experience and data
were taken into account in the policy development process, ensuring higher quality analysis
and support for implementation. All information gathered in Task 3 was fed into the wider
impact assessment regarding the analysis of policy options and any associated impacts.
Several methods were used in consultation for data collection – questionnaire surveys, semi-
structured interviews and document analysis.
General public and experts, including the main stakeholders, such as citizens, public
authorities, business entities and associations, civil societies, academic researchers were
reached by launching two questionnaire surveys – open public consultation and targeted
stakeholder consultation. Following Better Regulation Tool #52, open public consultation
survey aimed to enable the public and stakeholders to freely contribute to the impact
90
assessment study with their opinions, while targeted consultation survey addressed main
stakeholders of the study. Two data analysis methods were applied to interpret the results of
both surveys: descriptive statistics and thematic analysis. Descriptive statistics was used to
analyse closed quantitative responses to the surveys, while thematic analysis was applied to
interpret answers to open questions and the content of the position papers. Thematic analysis
is a data interpretation method that allows systematic approach to categorising qualitative
unstructured input by stakeholders into the hierarchy of topical categories. Thematic analysis
was supported by Nvivo software package. Thematic category maps were developed for data
visualisation by using open-source software Free Mind.
To complement and cross-check with the findings of quantitative surveys and evidence
collection in Task 2 semi-structured interviews were carried out with civil societies, public
authorities, academia, and business entities and associations. For making the study more
inclusive to opinions of the stakeholders the study team conducted both individual and group
interviews. The study team used thematic analysis for data interpretation supported with
thematic category maps for visualisation of the findings.
Furthermore, the study team applied observation and document analysis for collecting the
opinions of CARACAL and its CASG sub-group members and observers. Observation of the
CARACAL meeting was carried out by non-intrusive observation of CARACAL discussions
and making notes that were later used for the study purposes. Document analysis was used for
processing the written feedback submitted after each meeting by the CARACAL members and
observers.
IMPACT ASSESSMENT METHODS
Impact assessment provided the core output of the study with the assessment of the economic,
social and environmental impacts of each of the policy options identified. It brought together
data gathered through evidence collection and consultation activities. Impact assessment (Task
4) followed the methodology specified in the Better Regulation Guidelines and consisted of six
sub-tasks.
91
Figure 8: Task 4 workflow
Problem analysis aimed to identify and analyse the key problems to be addressed in the report
supporting the impact assessment of the CLP Regulation. It was carried out following the
methodology suggested in Better Regulation Guidelines, Tool #13 “How to analyse problems”.
Following Better Regulation Tool #16, baseline, i.e. “no policy change” scenario, was
developed. It provided a reference point for assessing changes and impacts, as it establishes a
basis for comparing the situation before and after an intervention.
A set of policy measures was developed to solve the problems in each of the seven areas that
were investigated in the study. Following the recommendations of Tool #16, policy measures
were grouped into several policy option packages. The long-list of policy options was
screened and some of the measures contained in policy option packages were discarded.
Impacts of all retained policy options were assessed. The main direct impacts were quantified
and monetised (both the baseline and the policy options under consideration). Furthermore,
indirect impacts were quantified, where possible, and if not then they were assessed
qualitatively with a clear indication of their nature and likely magnitude. Costs and benefits
were disaggregated, as far as possible, according to each identifiable action under the different
options and identified according to the standard typology of costs (e.g., administrative,
enforcement) and benefits (Tool #58 and #59). The assessment was undertaken in line with the
Better Regulation Guidelines and, in particular, Chapter 8 (“Methodologies for analysing
impacts in impact assessments, evaluations and fitness checks”).
The options were compared both to the baseline scenario and to each other and provide the
Commission with a recommended option or combination of options. This sub-task brought
92
together both quantitative and qualitative findings to present a coherent set of conclusions and
recommendations. Policy options were compared based on their effectiveness (i.e., the
potential to deliver on the objectives), efficiency and coherence, against the objectives of the
CLP and specific options defined in the earlier tasks.
SCREENING REGISTERED SUBSTANCES
Databases considered
The focus was on the REACH registered substances, including biocidal and pesticidal active
substances. Cosmetics have only been included if they are present in one of these inventories.
Regarding biocides and pesticides only active substances that can currently be used in the
market were kept, e.g. biocide active substances that have been assessed and not approved for
any product type were excluded.
With regard to the REACH registered substances ECHA used the recently published chemical
universe (https://echa.europa.eu/universe-of-registered-substances). Substances present in
more than one inventory (duplicates) were identified based on the presence of at least one
common identifier (EC number, CAS number or substance names). The combined substance
inventory contains 23751 unique substances, out of which 23043 are only registered under
REACH, 379 are only active pesticides, 98 are only active biocides and 231 are in more than
one inventory (most of which are registered under REACH). There are 2264 substances
registered according to Annex X of REACH (this number is used for the projections of basket
3). 12239 substances have at least one active registration according to Article 10 and an
additional 509 substances are active pesticides and/or biocides. The remainder of the 23751
substances are intermediates registered under REACH, NONs (claimed or unclaimed) that have
not been updated under REACH or only have registrations that are currently ceased. The
inventory of substances is provided as a separate dataset (substance_inventory.xlsx, see annex).
It does not include substances that are only notified to the CLP inventory but have not been
registered.
Identification of registered substances
For each endpoint16
, substances have been divided into 3 baskets:
Basket 1 - Substances with confirmed hazard(s): For endpoints included in CLP these are
based on either their harmonised classification (inclusion in Annex VI to CLP) or the reported
self-classification in the registration dossier17
. For other endpoints these are based on
identification as SVHCs (inclusion in the Candidate List), identification under BPR or agreed
in the ED/PBT Expert Groups. Hazard(s) are based on available information; lists as well as
numbers of substances are provided.
Basket 2 - Substances where the hazard(s) are under consideration: These are substances
with on-going data generation or assessments; lists as well as numbers of substances are
16
ED, PBT, vPvB, PMT and vPvM
17
Certain entries on Annex VI to CLP are conditional (e.g. the classification only applies if certain impurities are
present). These have been removed from the analysis. In addition, self-classification can be impacted by the
presence of impurities. In this analysis, no attempt has been made to identify and remove substances if the self-
classification is based on impurities.
93
provided; it includes also an estimate on how many would likely turn out positive (based on
past experience).
Basket 3 - Guestimate on how many substances could have the same hazard(s) among the
remaining REACH registered substances: Numbers provided were extrapolated to all
REACH registered substances using the frequencies of the hazards in Basket 1 and 2. The
numbers provided are associated with a very high uncertainty. It is not possible to provide lists
of substances as these are extrapolations and no substance specific data have been considered.
Each substance in the analysis has been assigned to either Basket 1 or 2 (see above) for a given
hazard property. Substances have been assigned to Basket 1 on the basis of the criteria set out
above.
Basket 2 has been compiled using a number of input lists for each hazard property: e.g.
CORAP18
substances, substances under ongoing assessment by ED or PBT Expert Groups, etc.
It is expected that only a proportion of the substances in basket 2 will have the hazard confirmed
and consequently move to Basket 1 in the future. Different weighting factors have been
assigned to the input lists, based on the likelihood that the hazard will be confirmed as follows:
Low likelihood that the hazard will be confirmed - weighting factors between 0-0.3;
Medium likelihood that the hazard will be confirmed - weighting factors between 0.4-0.6;
High likelihood that the hazard will be confirmed weighting factors between 0.7-1.
If a substance appears in more than one input list, it is counted only once considering the highest
weighting factor/highest probability that the hazard will be confirmed. In basket 2, the total
number of substances expected to have the hazard confirmed, and consequently move to basket
1 in the future, is calculated by adding up all the weighting factors for the substances in each
endpoint basket19
. It should be recognised that uncertainties apply to the use of these weighting
factors but in most cases the number of substances in question is relatively limited. Therefore,
the size of the weighting factor will not have a significant bearing on the overall number of
substances predicted to fall in Basket 1.
Basket 3 represents an estimation based on the assumption that the same proportion of
hazardous substances exists regardless of the ‘Annex’ registered i.e. regardless of their tonnage.
The starting point for the estimations is
 the number of substances with the hazard confirmed (Basket 1) and
 the number of Basket 2 substances which are estimated to be confirmed with the
respective hazard (see above).
For Annex X substances it is considered that the hazards are already known (Basket 1) or under
investigation (Basket 2) - in other words “dealt with”. As the proportion of Annex X substances
registered at annex X of REACH is about 9% of the substances in scope of this exercise20
, the
18
Community Rolling-out Action Plan
19
For example, if 5 substances were in basket 2 for a particular endpoint, each with a weighting of 0.2, 1 substance
(5 x 0.2) would be expected to be confirmed as having the hazard property in question.
20
There are 2264 Annex X substances
94
figure for annex X was simply multiplied by a factor of 11 to derive the projections for basket
3.
It is however noted that the estimations for basket 3 have a high degree of uncertainty and
should be used only as very basic indicative numbers. Moreover, these estimations do not
consider whether there is sufficient information available for those substances to enable
deciding on the hazardous properties (e.g. substances registered with Annex VII and VIII have
in general a very limited data set).
BEHAVIOURAL EXPERIMENT FOR DIGITAL LABELLING
The aim of the behavioural experiment was to investigate consumers’ needs with respect to
the labelling of chemical substances. Therefore, a state-of-the-art behavioural experiment
was designed and conducted to collect data on consumers’ cognition and preferences.
Research Questions
Overall, the experiment answers five research questions:
What is the level of understanding of chemical and detergents labels?
What is the importance of different elements contained in labels? Which information is
considered essential?
How do consumers interpret labels with respect to hazards and safe use?
Does label simplification and the introduction of digital tools positively or negatively affect
consumers’ understanding and perceptions?
Do consumers prefer information to remain on the physical label or to be communicated via
digital tools?
In the subsequent section the methodological approach is presented on how the behavioural
experiment design informs the research questions. Hereafter the results from the main data
collection are summarized.
Methodology
In the following, the experiment design including products, treatments, main variables as well
as further methodological considerations are presented. The general structure of the
experiment is summarised in Table 5.
95
Table 5: General Structure of the Behavioural Experiment
Online behavioural experiment + supporting consumer survey
Duration 15 Minutes
Target audience:
Consumers;
Nationally
representative for
age and gender (hard
quotas) and
education and
income (soft quotas)
Incentives:
Flat-fee payment
and additional
incentives for
questions on
objective
understanding
Pilot:
To test experiment
before launch of
main fieldwork with
n=101 in DE
Sample size main
data collection:
N=4,003 with
n 1,000 collected
in each of DE, FR,
EL, RO
Test method: Randomised controlled trials using various types of treatments for robust
and generalisable results.
In order to answer the research questions a randomised controlled trial-design was
implemented that systematically varied types of labelling-treatments (see section 1.1.3). In
addition, a supporting consumer survey was designed in order to collect further insights on
non-behavioural variables. Furthermore, the experiment was incentivised (see section 1.1.5).
In preparation of main data collection, a pilot was implemented in July 2021. It included n=101
observations from Germany and aimed at investigating the correct functioning of the
experimental set-up and programming. Therefore, timing to complete the study as well as
randomisation of treatment assignment was thoroughly checked. Furthermore, in the pilot
study it was assured that “don’t know”- or “other”-frequencies for questions were not a
problem and that participants were able to understand tasks (open question at the end of the
pilot). After minor revisions of the experimental design and questionnaire, the main data
collection script was programmed and the study was fully translated.
Main data collection was performed in September and October 2021 in four Member States,
i.e. Germany, France, Greece and Romania with a total of 4,003 participants. The target
audience was consumers in general, recruiting for representative general population samples
per country. The complete experiment script has been provided to the EC after sign-off in
September 2021.
Overview of Modules
The experiment consisted of five subsequent modules that are displayed in Table 6. Each
participant went through the same sequence of modules and completed several tasks on label
understanding, interpretation as well as preferences regarding labelling elements and their
communication channels.
96
Table 6: Overview of Modules in Behavioural Experiment
Module 1 Screening and introduction
 Achieve representative sample
 Explanations on study objectives
Module 2 Label understanding and interpretation
Objective understanding of labels
Perception of labels
Behaviour given label information
Module 3 Rating of information contained in labels
Importance of label elements
Understandability of labels
Ease to find information on labels
Module 4 Comparative Choice
1) Ability to select less harmful product
Module 5 Label preferences, socio-demographic aspects and attitudes
2) Preference for analogue versus digital labelling
3) Experience with chemicals, chemical worker, training
4) Digital readiness
5) Behavioural variables, i.e. trust and risk aversion
Products
At the heart of the experiment stand two products containing chemical substances that fall
either exclusively under the CLP Regulation or under both the CLP and the Detergents
Regulations21
. The two products were carefully selected so that they cover products consumers
are familiar with and frequently handle in their personal life. A further requirement for product
selection was that products differ in their degree of potential harmfulness, i.e. with respect to
their physical, health-related as well as environmental hazards. Following desk research on
representative product types available on consumer markets, the choice fell on a laundry
detergent and a glue.
In order to design the experiment as realistic as possible, further desk research was performed
and representative products were identified. These representative products were replicated
for the purpose of the experiment and can be purchased in supermarkets, drugstores or DIY-
stores. Hence, the experimental products are replica of actual laundry detergents and glues
consumers handle in their everyday life. Furthermore, desk research was performed to identify
substances usually contained in the products, to ensure that the ingredients were realistic. The
same applies to the labelling information on hazards as well as precautions on the selected
products. To avoid behavioural bias from brand familiarity and personal product preferences,
the products were given a fictive name. Similarly, the manufacturer’s name and company
information were fictive and framed in a neutral way.
21
Given that detergents’ labelling falls by default under these two pieces of EU chemicals legislation.
97
Treatments
Following product selection, different types of labels were designed for the laundry detergent
and glue. Overall, the experiment tested three different types of labels which are presented in
the following.
Status Quo Label
The first label was the Status Quo Label which comprises labelling requirements from current
legislation. It contained all informational elements necessary, i.e. dosage information,
ingredients, UFI-code, GHS-pictogram, signal words as well as hazard and precautionary
statements. Figure 9 displays the Status Quo Label for the laundry detergent and Figure 10
displays the variant for the glue.
Figure 9: Status Quo Label – Laundry Detergent Figure 10: Status Quo Label – Glue
Simplified Label with QR Code
Following the main research questions, an objective of the experiment was to test whether
labels of chemical products can be simplified and whether digital tools could support
consumers’ understanding. Hence, the second treatment included the Simplified Label with a
QR Code.
In the case of the laundry detergent, the simplification consisted of reducing the dosage table,
i.e. instead of the full dosage table including separate rows for different degrees of water
hardness, the Simplified Label only contained one row for medium water hardness.
Furthermore, the list of ingredients was removed from the package label. The reduced /
removed information was made available via a website which could be accessed via a QR Code
added to the packaging. Hence, the full dosage table for different degrees of water hardness
and the list of ingredients was available on the website. Furthermore, the label was amended
by further pictograms that were taken from A.I.S.E. (International Association for Soaps,
98
Detergents and Maintenance Products).22
The GHS-pictogram, signal word and hazard and
precautionary statements remained on the label in accordance with current legislation. Figure
11 displays the label for the laundry detergent as well as the website to be opened when
scanning the QR code.23
Figure 11: Simplified Label with QR Code – Laundry Detergent
In a similar way, the simplified label of the glue was designed. Information on the ingredients
was removed from the package and moved to a website to be accessed via a QR code.
Additionally, A.I.S.E. icons were added to the packaging while information on hazards and
precautions, pictograms and signal word remained in accordance with current regulation (status
quo). Figure 12 displays the Simplified Label for the glue as well as the website on ingredients.
22
A.I.S.E. (2021). Safe Use Icons. Retrieved from: https://www.aise.eu/library/artwork/safe-use-icons.aspx
(30.06.2021)
23
Please note that scanning the QR-code was mimicked in the experimental design by a pop-up to be opened in
the browser. More information on this aspect may be found in section 0.
99
Figure 12: Simplified Label with QR Code – Glue
No Label Baseline
Lastly, one of the tested treatments displayed only the front packaging of the two products.
Hence, it is referred to as the No Label Baseline. It was introduced as a methodological control
in order to robustly test whether labelling information in the other two treatments indeed
informs consumers’ understanding. Participants in the No Label Baseline answered the same
set of questions as in the other treatments but without consulting the labels, i.e. responses were
based on the experience consumers have with the products. Figure 13 and Figure 14 display
the image for the laundry detergent and glue.
Figure 13: No Label Baseline – Laundry Detergent Figure 14: No Label Baseline – Glue
Randomisation, Variables and Tasks
At the beginning of the experiment participants were randomly assigned to one of the two
products, i.e. either laundry detergent or glue, and to one of the three treatments, i.e. either
Status Quo Label, Simplified Label or No Label Baseline. They remained within their treatment
for the whole course of the experiment and underwent several tasks and questions.
The main variables elicited in the experiment were:
Objective understanding of labels;
100
Ability to identify a less harmful product given label information;
Perception of labels;
Anticipated behaviour given label information;
Rating of importance of label elements as well as understandability and ease to find
information.
The exact framing of questions and tasks was provided with the scripting document. For all
label-related questions participants saw the image of the product on the left side of the screen.
The question text was displayed on the right side of the screen. Furthermore, in some of the
treatments, participants were able to enlarge labelling information which is described in the
subsequent paragraph.
Behavioural Variables when Consulting Labels
In testing consumers’ understanding and appreciation of labels, an important aspect is whether
they indeed consult the label. In reality, consumers have a physical packaging in front of them
and whenever they need information contained in the label, they take the packaging and read
the relevant labelling section. Ideally, the experiment would allow tracking whether the
participant actually looked at the label at display – which for example could be done by
implementing eye-tracking during the tasks. As eye-tracking was not in scope of the underlying
study, the experiment design included a technical featured that mimicked “zooming” on
(looking at) the label. This zooming-function allowed participants to hover with their mouse
cursor over the label image in order to open a pop-up of the enlarged label. While the whole
packaging was by default displayed in small size, i.e. relevant information on hazards and
precautions was in very small font, the zoomed-label was of readable size. Figure 15 and Figure
16 display zooming (pop-up) for the Status Quo Label for the laundry detergent as well as the
glue.
101
Figure 15: Zooming on Status Quo Label – Laundry Detergent
Figure 16: Zooming on Status Quo Label – Glue
The experiment set-up allowed recording individual zooming of participants at all points of the
survey, i.e. for each question referring to the label elements. Nevertheless, it must be noted that
this experimental feature can only serve as an indication of whether participants indeed read
the label thoroughly. Furthermore, in reality consumers might have different motives to consult
the label, e.g., to minimise adverse effects when an accident occurs. This cannot be mimicked
in the underlying design.
102
As introduced above, one treatment was a simplified label that also introduced a digital
element, i.e. a QR code to a website containing further information (see section 0). In reality
consumers would open a QR code by using their smartphone. As this actual scanning of a QR
code was not feasible in the experimental environment, the experiment introduced an open-
website-function. By hovering over a link displayed at the bottom of the screen a pop-up of
the website opened on screen. Again, the opening behaviour was tracked for all relevant
questions.
The last behavioural variable that was elicited over the course of the experiment was the time
spent on answering each question. This variable could serve as a control for reading time, i.e.
the longer participants spent on screen, the higher the probability of reading and consulting the
labelling information.
Comparative Choice Task
As indicated above, the aim of the experiment was also to measure consumers’ ability to
identify a potentially less harmful product by reading and understanding labelling
information. Therefore, the experiment included a comparative choice task where participants
were presented with two variants of the product, i.e. the product “original” and its “twin”. The
product twins were constructed in parallel to their original versions and differed only with
respect to the potential hazards for human health and the environment.24
For the laundry
detergent the product original was less harmful than its twin, while for the glue the original
was more harmful than the twin.
Within the task, participants saw both the original and the twin next to each other on screen
and had to select the potentially less harmful variant. The alignment to either right or left
was fully randomised. Furthermore, participants repeated the task for both the laundry
detergent as well as the glue (order was randomised as well).
Each participant remained within the treatment they were assigned to at the beginning of the
study, i.e. when assigned to the Status Quo Label, the participant also answered the
comparative choice task on the Status Quo Label. Additionally, the comparative choice task
included the zooming-feature for the Status Quo and Simplified Label as described above. In
order to enlarge labelling details, participants were able to hover over both of the label images
of the original and twin and a pop-up opened. Figure 17–Figure 22 display the original and
twin product for the laundry detergent and glue in the Status Quo Label, Simplified Label and
No Label Baseline treatment.
24
Furthermore, the fictious brand and company information differed.
103
Figure 17: Comparative Choice Task for Status Quo Label – Laundry Detergent
Figure 18: Comparative Choice Task for Status Quo Label – Glue
104
Figure 19: Comparative Choice Task for Simplified Label – Laundry Detergent
Figure 20: Comparative Choice Task for Simplified Label – Glue
105
Figure 21: Comparative Choice Task for No Label Baseline – Laundry Detergent
Figure 22: Comparative Choice Task for Simplified Label – Glue
Since for the No Label Baseline the package images only contained the front of the packaging
without any information on product hazards, participants that were assigned to the treatment
not only were allowed to choose between either of the two products at display but also were
able to choose “don’t know / I would need more information to make that choice”. This
measure was introduced after the pilot analysis.
Further Variables
Following the experimental tasks where labels were at display, the last part of the experiment
consisted of a consumer survey. The purpose of the survey was two-fold. On the one hand,
preferences for receiving labelling information (on-pack versus digital) were elicited. On
the other hand, participants’ characteristics were collected. These include personal or
professional experience with chemical products, digital readiness as well as trust and risk
attitudes.
106
Incentives
As it is common practice in behavioural science, participants were incentivised in the
experiment in two ways. Firstly, they received a flat fee for their overall time spent on the
tasks. By that it was ensured that they reciprocate by paying attention and providing answers
to their best knowledge and ability.
Secondly, the questions on objective understanding of labelling information were incentivised
by paying an additional amount per correct answer. This methodological measure was
applied to ensure that participants paid specific attention to the task itself and were motivated
to solve the questions correctly. Nevertheless, it must be noted that this procedure only mimics
the incentives of consulting a chemical label in the real world. If an accident occurs, consumers
are inherently motivated to reduce the negative health impacts and pay attention to the label.
This scenario and the inherent motives cannot be replicated by the experimental set-up.
Overview on the Data Set
The experiment was conducted with 4,003 participants in September and October 2021. Data
collection took place in four Member States, i.e. Germany (1,000), France (1,001), Romania
(1,000) and Greece (1,002) and the median time to complete the experiment was 17 minutes.
Sample description
Participants were recruited from an actively-managed online-panel and hard quotas on age and
gender were applied in order to reach representativeness. Furthermore, soft quotas on education
and income were applied. Table 7 gives an overview on the sample characteristics per country.
Table 7: Sample Description
DE
(N=1,000)
FR
(N=1,001)
RO
(N=1,000)
EL25
(N=1,002)
Age mean (s.d.) 50.26 (16.53) 49.53 (16.94) 47.98 (16.11) 46.05 (14.89)
Gender (male /
female /
other-diverse)
49.3% /
50.7% /
0%
48.2% /
51.8% /
0.1%
48.4% /
51.6% /
0%
49.0% /
50.6% /
0.4%
Education26
(low /
Medium /
high)
19% /
53% /
28%
9% /
55% /
36%
20% /
57% /
22%
8% /
46% /
46%
Income27
(low /
medium /
high)
34.0% /
31.6% /
34.0%
34.0% /
35.5% /
30.6%
43.1% /
50.6% /
6.2%
31.0% /
40.6% /
28.4%
25
Given that quotas on age in Greece were difficult to reach, in the analysis individual weights for Greek
participants were used in order to draw upon representative results. The reason was that especially elderly
participants are challenging to recruit for online studies given limited access to devices.
26
As can be seen from the sample description consumers with lower educational level are slightly
underrepresented in the sample. Especially in Greece the share of participants holding a university degree is
comparatively large.
27
Please not that income categories were defined within each country, i.e. using different tertile cut-off values for
each country, because income distribution in absolute monetary terms differs per country.
107
Treatment assignment
As described in the methodological section, participants were randomly assigned to one of two
products, i.e. either laundry detergent or glue, and to one of three labelling treatments, i.e. either
Status Quo Label, Simplified Label (QR) or No Label Baseline. Table 8 displays the number
of observations per product-treatment-combination.
Table 8: Treatment Assignment
Laundry Detergent Glue
Status Quo Label 16.7% 16.7%
Simplified Label (QR) 16.7% 16.7%
No Label Baseline 16.6% 16.6%
Furthermore, in the comparative choice task participants were randomly assigned to the order
of products to be displayed, i.e. either laundry detergent first, then glue or glue first, then
laundry detergent. Within the task the alignment of product variants was additionally
randomised, i.e. original left and twin right or twin left and original right. Again, data reveals
that for both order and variant alignment randomisation worked well (50% of the sample in
each display condition).
RQ 1: What is the level of understanding of chemical and detergents labels?
To answer the first research question on consumers’ understanding, the experiment included
several questions which are presented in the following. All results are based on a comparison
of the Status Quo Label and the No Label Baseline in order to confirm whether current
legislation indeed enhances consumers’ understanding.28
Objective Understanding of Product Hazards
Based on the desk research performed to design the two products, different hazards apply to
the laundry detergent and glue. These include, for example: “Causes serious eye irritation”
(H319) or “Toxic to aquatic life with long lasting effects” (H411).29
The question was presented
as a set of correct as well as incorrect hazard statements and participants were asked to identify
the correct ones (additional payment for correct answer).
Figure 23 displays the percentage of participants that correctly answered the question on
product hazards by product.30
For the Status Quo Label of the laundry detergent 54% of the
participants answered the question on hazards correctly while only 8% in the No Label
Baseline were successful. The difference between the two conditions is highly significant
(p<0.001)31
.
28
Results on the performance of the Simplified Label with QR code may be found further below, i.e. section on
the fourth research question.
29
Please note that the hazards differed by product. As described in the methodological section the laundry
detergent was designed to be less harmful, while the glue included more hazards. The actual statements are
representative for products to be found in supermarkets, drugstores and DIY-stores. A complete list may be found
on the label-images provided in the methodological section.
30
For better readability, in the following results are rounded to the nearest whole number. Hence, it might be
possible that shares do not add up to 100%.
31
If not otherwise specified, the statistical tests were Chi-2-test analysing the relationships between answer
behaviour and categorial variables, i.e. treatments.
108
The same pattern can be observed for the glue – although objective understanding was lower
than for the laundry detergent. In the Status Quo Label treatment 29% of the participants
answered the question correctly while the percentage in the No Label Baseline was only 6%.
Again, the difference between the two labelling treatments is highly significant. An explanation
for the worse performance of the glue compared to the laundry detergent might be that the
product itself was constructed in a way to be more harmful, i.e. more hazard statements apply
to the product.
Figure 23: Objective Understanding of Product Hazards by Treatment
Notes: The question was: “Please select all statements that are true about the product displayed on the left:”
(Status Quo Label) and “Thinking about a [laundry detergent / glue], please select all statements that are usually
true about such a product:” (No Label Baseline).
Number of observations: N=1,333 (LD), N=1,335 (G)
Source: ConPolicy analysis of the experiment and survey data.
Furthermore, data reveals that 73% of the participants in the Status Quo treatment of the
laundry detergent zoomed in on the label, i.e. took a closer look at it. Of those who zoomed,
70% were able to answer the question on hazards correctly, while only 12% of those who did
not zoom were successful. The difference is again highly significant (p<0.001). The same may
be observed for the glue where 78% of the participants in the Status Quo treatment zoomed in
on the label. Of those who zoomed, 36% answered the question on hazards correctly, while
the share among those who did not zoom was only 4% (p<0.001).
The time spent to answer the question in the Status Quo treatment was on average 62 seconds
for the laundry detergent and 78 seconds for the glue. For both products a positive, significant
relationship between time spent to answer and performance in the question can be found (0.49
for laundry detergent and 0.48 for glue, both p<0.001). I.e. the more time participants spent on
the questions, the higher are the chances that they answer the question on product hazards
correctly.
In summary, the results show that providing labelling information and reading it helps
consumers to understand hazard information. Certainly not all consumers who were
provided with a label under current legislation (Status Quo Label) performed equally well but
compared to a situation where information is not available, they performed significantly better.
When consumers solely answered based on their personal experience of chemical products (No
Label Baseline) understanding was overall poor. Furthermore, participants were motivated
to consult labelling information in the experiment and when they did, they also performed
significantly better than when they did not actively read the label.
54%
8%
29%
6%
0%
10%
20%
30%
40%
50%
60%
Status Quo
Label
.
.
No Label
Baseline
Status Quo
Label
No Label
Baseline
Hazards (Percentage Correct)
Laundry Detergent Glue
109
Objective Understanding of Precautionary Measures
Similarly, different precautionary statements apply to the two products. These included for
example: “Keep out of reach of children” (P102) or “IF IN EYES: Rinse cautiously with water
for several minutes” (P305+P351).32
Again, the question was presented as a set of correct as
well as incorrect precautionary statements and participants were asked to identify the correct
ones (additional payment for correct answer).
Figure 24 displays the percentage of participants that correctly answered the question on
product precautions by product. It can be seen that the Status Quo Label again performs better
than the No Label Baseline. For both products the difference is highly significant (p<0.001).
For the laundry detergent 17% in the Status Quo Label treatment and 1% in the No Label
Baseline answered correctly. For the glue 12% in the Status Quo Label treatment and 0% in
the No Label Baseline answered correctly.
Figure 24: Objective Understanding of Precautions by Treatment
Notes: The question was: “From your reading of the label, when using this product would you: (Select all that
apply)” (Status Quo Label) and “When using a [laundry detergent / glue] would you: (Select all that apply)” (No
Label Baseline).
Number of observations: N=1,333 (LD), N=1,335 (G)
Source: ConPolicy analysis of the experiment and survey data.
When looking at zooming behaviour, 63% of the participants in the Status Quo Label of the
laundry detergent took a closer look at the label. Of those who zoomed on the label 26%
answered the question correctly while those who did not zoom only answered the question on
precautions correctly in 1% of the cases (difference highly significant, p<0.001). The same
pattern may be observed for the Status Quo Label of the glue where 66% of the participants
took a closer look at the label. Of those who zoomed 18% answered the question correctly,
while those who did not zoom only answered the question correctly in 2% of the cases
(difference highly significant, p<0.001).
Overall, participants in the Status Quo treatment spent 53 seconds to answer the question on
the laundry detergent and 68 seconds for the glue. Again, a positive significant correlation
between time spent and performance can be detected (0.40 for laundry detergent and 0.39 for
32
Again, these precautionary statements are only examples, and the complete list of applicable precautions may
be found in the methodological section of the report.
17%
1%
12%
0%
0%
10%
20%
30%
40%
50%
60%
Status Quo
Label
.
.
No Label
Baseline
Status Quo
Label
No Label
Baseline
Precautions (Percentage Correct)
Laundry Detergent Glue
110
glue, both p<0.001). I.e. the more time participants spent on the question, the higher are the
chances that they answer the question on product precautions correctly.
In summary, objective understanding of the precautions applicable to chemical products
follows the same pattern as for hazards. Receiving labelling information as defined by current
regulation (Status Quo Label) resulted in significantly better performance than answering
on experience (No Label Baseline). Overall, the understanding of precautions was poor and
on average worse than for hazards. This might be due to the amount of precautions to be taken
for safe use (especially for the glue, for which, as a more harmful product, legislation requests
a long list of precautionary statements). Similarly, the results show that the majority of
participants were motivated to consult labelling information in the experiment, and if they
did, they also had a better objective understanding.
Objective Understanding of Ingredients
Lastly, a question on the ingredients was presented. It was only asked of participants that were
assigned to the laundry detergent. Again, the question was presented as a set of correct, e.g.
“enzymes” or “perfumes”, and incorrect answer items and participants were asked to select the
correct ones (additional payment for correct answer).33
Figure 25 displays the percentage of participants that correctly answered the question on
product ingredients for the laundry detergent. It can be seen that 41% in the Status Quo Label
treatment answered the question on ingredients correctly, while the share was only 10% in the
No Label Baseline. The difference between groups is statistically highly significant (p<0.001).
33
The list of ingredients may be found on the label-images contained in the methodological section of the report.
111
Figure 25: Objective Understanding of Product Ingredients by Treatment
Notes: The question was: “From your reading of the label, which ingredients are contained in this product?
(Select all that apply)” (Status Quo Label) and “From you experience with laundry detergents which ingredients
are usually contained in such a product? (Select all that apply)” (No Label Baseline).
Number of observations: N=1,333
Source: ConPolicy analysis of the experiment and survey data.
Again, zooming behaviour is indicative for performance. Overall, 74% of the participants
zoomed in on the label. Among those who took a closer look the share of participants
answering correctly was 54%, while the share was only 3% among those who did not zoom
(p<0.001).
In addition, data reveals that in the Status Quo treatment participants spent on average 43
seconds to answer the question. The correlation between time spent and performance is positive
and significant (0.53, p<0.001), i.e. the more time participants took to answer the question, the
higher the chance of answering the question on product ingredients correctly.
In summary, the results confirm previous findings and show that labelling information
enhanced consumers understanding of ingredients as well. Again, participants in the
experiment were overall willing to consult the label and if they did, they performed
significantly better.
Ability to Identify a Less Harmful Product
Further evidence on consumers’ understanding of labelling information can be taken from the
comparative choice task. Participants were asked to identify the less harmful product
among two products which differed with respect to their properties.
For the laundry detergent, the product original was less harmful than its twin, i.e. less hazards
and precautions applied. Furthermore, the GHS pictogram and signal word differed. Further
information on the product labels presented in the task may be found in the methodological
section of the report.
Figure 26 displays the percentage of participants correctly identifying the original product to
be less harmful than its twin. As can be seen 64% in the Status Quo treatment answered the
question correctly. In the No Label Baseline performance was significantly worse because
participants were asked to answer the question based on their experience without any further
information. Since the No Label Baseline only included the front packaging without any
41%
10%
0%
10%
20%
30%
40%
50%
60%
Status Quo
Label
No Label
Baseline
Ingredients
(Percentage Correct)
112
information on hazards (pictogram, statements), the majority of participants (56%) selected
that they don’t know the answer or would need more information to make the choice. 16%
chose the correct product and 28% chose the wrong product. Again, the difference between the
treatments is statistically highly significant (p<0.001).
Figure 26: Comparative Choice Task Laundry Detergent by Treatment
Notes: The question was: “Please take a look at the two laundry detergents. Taking into consideration the
information available here, which product is less harmful, i.e. less hazardous for human health or the
environment?”. “Don’t know”-category only available for No Label Baseline.
Number of observations: N=1,340 (Status Quo Label), N=1,328 (No Label Baseline)
Source: ConPolicy analysis of the experiment and survey data.
72% of the participants zoomed on both labels at display, 20% on one of the two and 9%
did not zoom. Of those who zoomed on both 67% of the participants answered the question
correctly, of those who zoomed on one 56% answered correctly and of those who did not zoom
58% answered correctly (difference is significant, p=0.002).
For the glue, the product original was more harmful than its twin, i.e. more hazards and
precautions applied to it. Furthermore, the number of GHS-pictograms differed. Further
information on the product labels presented in the task may be found in the methodological
section of the report.
Figure 27 displays the percentage of participants correctly identifying the twin product to be
less harmful than the original. Again, the same pattern may be observed. In the Status Quo
Label treatment, the majority of 68% selected the correct product. In the No Label Baseline
the majority of 66% indicated that they did not know the answer and needed more
information for making their choice. The share of choosing the correct product was 16% and
the share of choosing the incorrect product was 18%. Again, the difference between the two
treatments is statistically highly significant (p<0.001).
64%
16%
36%
28%
56%
0%
20%
40%
60%
80%
100%
Status Quo Label No Label Baseline
Comparative Choice:
Laundry Detergent
Original Twin don't know
113
Figure 27: Comparative Choice Task Glue by Treatment
Notes: The question was: “Please take a look at the two glues. Taking into consideration the information available
here, which product is less harmful, i.e. less hazardous for human health or the environment?”. “Don’t know”-
category only available for No Label Baseline.
Number of observations: N=1,340 (Status Quo Label), N=1,328 (No Label Baseline)
Source: ConPolicy analysis of the experiment and survey data.
Regarding zooming behaviour, it can be found that 68% of the participants in the Status Quo
Label treatment took a closer look at both products at display, 25% looked at one of the two
and 7% looked at none. Of those who zoomed on both products 71% were able to correctly
identify the less harmful product, among those who looked at one product the share of correct
answers was 64% and of those who did not zoom the share was 61% (p=0.03).
In conclusion, results are confirmative of the findings from the previous sections. When
labelling information was available (Status Quo Label), the majority of consumers were
able to identify a less harmful product. In contrast, when labelling information was not
available, i.e. CLP information was not provided (No Label Baseline), consumers were not
able to correctly identify the less harmful product but rather indicated that they would need
more information to make their choice. Again, it can be observed that experiment-participants
were willing to consult the label for further information and when they did, they at least
slightly performed better than without zooming in on information. Nevertheless, it must be
noted that even without zooming on further information such as a readable list of hazards and
precautionary statements, the packaging was already indicative of the degree of harmfulness,
i.e. the GHS-pictograms on the packaging for example already showed which product is more
harmful.
Lastly, it must be noted that results only provide information on consumers’ objective
understanding and not whether labelling information also causes consumers to purchase the
less harmful product. Furthermore, results also cannot demonstrate whether better objective
understanding also causes consumers to behave more appropriately in case of an accident, i.e.
whether they would follow instructions to minimise adverse effects. Therefore, the follow-up
questionnaire of the experiment can shed further light on consumers’ behaviour (see section on
the third research question).
32%
18%
68%
16%
66%
0%
20%
40%
60%
80%
100%
Status Quo Label No Label Baseline
Comparative Choice:
Glue
Original Twin don't know
114
Rating of Understandability of Relevant Label Elements
Next to the objective questions on label understanding, the experiment contained a subjective
understanding question. Participants were asked to indicate the perceived understandability
of different label elements such as the hazard and precautionary statements, GHS-pictograms,
ingredient lists or dosage instructions. The question was elicited on a 5-point-Likert-scale from
“very easy to understand” to “very difficult to understand”.
Figure 28 displays the subjective understandability of the Status Quo Label for the laundry
detergent. All aspects related to the CLP Regulation performed well and were perceived as
at least rather understandable by the vast majority of participants (above 70%). The only
aspect that stands out to be different is marketing information. Here only 48% of the
participants rated information as understandable.
Figure 28: Rating of Understandability of Label Elements (Status Quo Label, Laundry Detergent)
Notes: The question was: “Still looking at this label, how easy to understand do you find each piece of
information?”.
Number of observations: N=670
Source: ConPolicy analysis of the experiment and survey data.
Figure 29 displays the subjective understandability of ingredients information of the Status
Quo Label for the laundry detergent. Compared to the previous results on CLP-related labelling
elements the rating was lower. Nevertheless, the majority of the participants indicated that
specific ingredient information was (rather) easy to understand.
36%
33%
31%
44%
40%
33%
24%
32%
45%
18%
42%
40%
39%
38%
45%
42%
42%
40%
39%
38%
39%
43%
40%
30%
44%
44%
40%
34%
12%
17%
16%
10%
13%
15%
21%
15%
11%
33%
11%
11%
14%
16%
3%
4%
6%
3%
3%
5%
8%
6%
2%
8%
1%
3%
3%
5%
1%
1%
3%
1%
2%
5%
3%
1%
1%
3%
0%
0%
1%
3%
3%
3%
3%
2%
3%
3%
5%
2%
2%
8%
2%
2%
3%
4%
0% 20% 40% 60% 80% 100%
Statements to prevent adverse effects
Statements on precautions
Statements on products hazards
Signal word
Hazard pictogram
Information relevant in case of intoxication
Weblink to receive full ingredients list
List of ingredients
Quantity
Marketing information
Dosage recommendations
Instructions for use
Supplier contact information
Name of the product
Very easy to understand Rather easy to understand
Neither easy nor difficult to understand Rather difficult to understand
Very difficult to understand Don’t know
115
Figure 29: Rating of Understandability of Label Elements on Ingredients (Status Quo Label, Laundry Detergent)
Notes: The question was: “Still looking at this label, how easy to understand do you find the specific information
on the ingredients contained in the product?”.
Number of observations: N=670
Source: ConPolicy analysis of the experiment and survey data.
Lastly, Figure 30 displays the subjective understandability of the Status Quo Label for the glue.
Again, the ratings of CLP-related information are good with a majority of over 70%
indicating that information was very or rather easy to understand. The only aspect that stands
out is marketing information which received a lower understandability rating (48%).
Figure 30: Rating of Understandability of Label Elements (Status Quo Label, Glue)
Notes: The question was: “Still looking at this label, how easy to understand do you find each piece of
information?”.
Number of observations: N=670
Source: ConPolicy analysis of the experiment and survey data.
In conclusion, the data shows that overall consumers perceived relevant labelling elements
as (rather) understandable. Nevertheless, it must be emphasised that this result is based on
24%
22%
29%
28%
20%
32%
35%
42%
32%
32%
24%
22%
19%
21%
21%
11%
11%
5%
12%
15%
4%
6%
2%
4%
7%
4%
4%
3…
3%
5%
0% 20% 40% 60% 80% 100%
Preservatives
Allergens
Perfumes
Enzymes
Surfactants
Very easy to understand Rather easy to understand
Neither easy nor difficult to understand Rather difficult to understand
Very difficult to understand Don’t know
42%
40%
42%
53%
48%
34%
31%
38%
17%
40%
32%
39%
41%
41%
41%
34%
37%
36%
36%
40%
31%
42%
34%
36%
11%
11%
12%
7%
9%
14%
19%
12%
31%
11%
18%
17%
3%
5%
2%
3%
3%
6%
9%
3%
9%
4%
6%
4%
0%
0%
1%
0%
1%
6%
3%
3%
2%
1%
5%
2%
2%
3%
2%
2%
2%
4%
2%
4%
10%
2%
6%
3%
0% 20% 40% 60% 80% 100%
Statements to prevent adverse effects
Statements on precautions
Statements on products hazards
Signal word
Hazard pictogram
Information relevant in case of intoxication
List of ingredients
Quantity
Marketing information
Instructions for use
Supplier contact information
Name of the product
Very easy to understand Rather easy to understand
Neither easy nor difficult to understand Rather difficult to understand
Very difficult to understand Don’t know
116
an individual and subjective self-assessment. When looking at the objective understanding of
safe use information contained on labels performance was rather poor.
Rating of Ease to Find Relevant Label Elements
In order to understand label information, it is also important that consumers are able to find all
the information contained on a label in an easy way. Hence, the experiment included a question
on the subjective ease to find relevant label elements. The question was elicited on a 5-point-
Likert-scale from “very easy to find” to “very difficult to find”.
Figure 31 displays the rating of the ease to find label elements for the Status Quo Label of the
laundry detergent. Over 60% of the participants indicated that CLP-related information was
very or rather easy to find. Additionally, dosage recommendations provided as a table on the
label were perceived as very or rather easy to find by 85% of the participants. On the other
hand, marketing information was perceived as easy to find by only 48% of the participants.
Figure 31: Rating of Ease to Find Label Elements (Status Quo Label, Laundry Detergent)
Notes: The question was: “Still looking at this label, how easy is it to find each piece of information?”.
Number of observations: N=670
Source: ConPolicy analysis of the experiment and survey data.
Figure 32 displays the rating of the ease to find label elements for the Status Quo Label of the
glue. Again, all CLP-related elements were very or rather easy to find (above 60%) while
marketing information stands out with a lower rating (36%).
33%
30%
27%
44%
45%
28%
22%
37%
46%
19%
45%
41%
36%
36%
42%
39%
40%
37%
33%
34%
35%
42%
38%
29%
40%
39%
37%
35%
16%
17%
18%
12%
13%
19%
22%
14%
10%
29%
10%
13%
16%
14%
4%
8%
7%
3%
5%
9%
9%
4%
3%
8%
2%
3%
5%
7%
1%
3%
5%
2%
2%
7%
7%
1%
1%
6%
1%
1%
1%
4%
3%
3%
3%
2%
2%
4%
5%
2%
2%
8%
2%
3%
4%
4%
0% 20% 40% 60% 80% 100%
Statements to prevent adverse effects
Statements on precautions
Statements on products hazards
Signal word
Hazard pictogram
Information relevant in case of intoxication
Weblink to receive full ingredients list
List of ingredients
Quantity
Marketing information
Dosage recommendations
Instructions for use
Supplier contact information
Name of the product
Very easy to find Rather easy to find
Neither easy nor difficult to find Rather difficult to find
Very difficult to find Don’t know
117
Figure 32: Rating of Ease to Find Label Elements (Status Quo Label, Glue)
Notes: The question was: “Still looking at this label, how easy is it to find each piece of information?”.
Number of observations: N=670
Source: ConPolicy analysis of the experiment and survey data.
In conclusion, results on the ease to find label elements on the packaging given current
regulations are positive. The majority of the participants indicated that the relevant elements
are (rather) easy to find.
Conclusion
Taken the results from the previous section together, it can be shown that labelling
information under current regulation (Status Quo Label) performs systematically better
than when consumers are not provided with CLP- and Detergent-relevant information.
Overall, objective understanding is rather poor and performance of consumers is dependent on
the amount of information that needs to be processed, i.e. is displayed on the label. For a more
harmful product, legislation requires more text to be displayed on the label, which might be
especially problematic on small packaging. Nevertheless, participants in the experiment were
motivated to consult the label and were partially able to find relevant information.
As flagged in the methodology section, the experiment was only able to mimic consumers’
decision context, i.e. they found themselves in an artificial environment and were paid
monetary incentives for their performance in the tasks. Nevertheless, when it comes to the
actual health of consumers and their relatives, one would expect that they are even more
motivated to read and understand the specifics of chemical substances. In that manner, the
results support that current legislation is helpful for consumers’ understanding.
One other aspect that makes the experimental set-up different is the time spent on the label, or
at least, the time spent on answering questions on objective understanding. Data reveals that
participants take rather sufficient time to answer questions and there also exists a positive
correlation between time spent on the question and performance. On the one hand, this is a
39%
38%
39%
50%
55%
29%
38%
38%
17%
37%
29%
40%
39%
39%
40%
32%
30%
35%
37%
37%
29%
43%
35%
35%
15%
14%
13%
9%
8%
14%
15%
13%
28%
11%
18%
15%
4%
5%
4%
5%
3%
8%
5%
4%
12%
5%
7%
4%
1%
2%
2%
1%
2%
10%
3%
4%
5%
2%
7%
3%
2%
2%
2%
2%
2%
4%
2%
3%
9%
2%
3%
3%
0% 20% 40% 60% 80% 100%
Statements to prevent adverse effects
Statements on precautions
Statements on products hazards
Signal word
Hazard pictogram
Information relevant in case of intoxication
List of ingredients
Quantity
Marketing information
Instructions for use
Supplier contact information
Name of the product
Very easy to find Rather easy to find
Neither easy nor difficult to find Rather difficult to find
Very difficult to find Don’t know
118
positive result as it confirms that consulting a label supports consumers’ understanding. On the
other hand, spending that much time on a label of a chemical substance or detergent is rather
uncommon (e.g. in shopping situations labels are not consulted this thoroughly and in the case
of an accident induced stress could also lower consultation times).
Lastly, results show that consumers subjectively rate the Status Quo Label in a positive way.
Overall, CLP- and Detergent-relevant information items are rated as both easy to
understand as well as easy to find. This stands in contrast to the rather poor objective
understanding and might be because subjective understanding is self-reported, i.e.
consumers overestimate their understanding. One aspect that systematically stands out in the
results was marketing information provided on the packaging. It was rated as more difficult to
understand and to find on the packaging. Certainly marketing information is not regulated by
CLP, however, in practice it takes a comparatively large space on the packaging of products
and competes with information relevant for safe use.
RQ 2: What is the importance of different elements contained in labels? Which
information is considered essential?
In order to answer the second research question on consumers’ perceived importance of label
elements, the experiment contained two questions which are presented in the following
sections. The first question was asked at the beginning of the experiment before the participants
saw the label images on screen, i.e. it was solely based on consumers’ experience with chemical
labels. By that the general label appreciation was elicited. The second question was asked at
a later stage of the experiment when the participants were already familiar with the labelling
content, i.e. they had already answered questions on objective understanding and label
interpretation. By that the label appreciation under current regulation was elicited.
Rating of Importance of Label Elements Without Seeing a Label
As indicated above, the importance of different label elements was elicited without label
display at the beginning of the experiment. Hence, the overall rating for the whole sample is
displayed regardless of treatment assignment. The question was elicited on a 5-point-Likert-
scale from “Absolutely essential” to “Not important at all”.
Figure 33 displays the rating of the importance of label elements for the laundry detergent.
CLP- and Detergent relevant information such as the hazard pictogram, signal word,
statements on hazards and precautions and dosage instructions were rated as either absolutely
essential or very important by more than 70% of the participants. The weblink to receive
the full ingredient list received a share of 44% and supplier contact information of 34%. The
lowest rating was assigned to marketing information with only 24% who indicated the
information to be absolutely essential or very important.
119
Figure 33: Rating of Importance of Label Elements Without Label (Status Quo Label, Laundry Detergent)
Notes: The question was: “Please think about your last purchase or use of a laundry detergent: In general, on
the packaging of a laundry detergent how important do you rate having the following pieces of information?”
Number of observations: N=4,003
Source: ConPolicy analysis of the experiment and survey data.
displays the rating of the importance of label elements for the glue. Again, the same patterns
may be observed. CLP-relevant information received high ratings of above 70%
(absolutely essential or very important). Supplier contact information received a lower rating
of 31% and the lowest importance was again attached to marketing information were 17% of
the participants rated the information to be absolutely essential or very important.
36%
33%
37%
37%
34%
42%
16%
37%
37%
7%
36%
36%
13%
30%
36%
37%
36%
33%
33%
29%
28%
33%
40%
17%
37%
32%
21%
30%
17%
19%
18%
17%
19%
17%
28%
18%
17%
32%
18%
19%
27%
24%
5%
6%
5%
7%
8%
6%
14%
7%
2%
22%
4%
7%
19%
9%
3%
3%
3%
4%
4%
4%
11%
4%
1%
19%
3%
5%
18%
6%
1%
1%
1%
2%
2%
2%
2%
1%
1%
3%
1%
1%
2%
1%
0% 20% 40% 60% 80% 100%
Statements to prevent adverse effects
Statements on precautions
Statements on products hazards
Signal word
Hazard pictogram
Information relevant in case of intoxication
Weblink to receive full ingredients list
List of ingredients
Quantity
Marketing information
Dosage recommendations
Instructions for use
Supplier contact information
Name of the product
Absolutely Essential Very Important Of Average Importance
Of Little Importance Not Important At All Don’t know
120
Figure 34: Rating of Importance of Label Elements Without Label (Status Quo Label, Glue)
Notes: The question was: “Please think about your last purchase or use of a glue: In general, on the packaging
of a glue how important do you rate having the following pieces of information?”
Number of observations: N=4,003
Source: ConPolicy analysis of the experiment and survey data.
Overall, the appreciation of different CLP- and Detergent-relevant label elements was
high. Even without seeing a label at display, consumers indicated that information on hazards
and precautions are highly important.
Rating of Importance of Label Elements When Seeing a Label
Participants assigned to the Status Quo Label treatment were asked the rating question a
second time, i.e. after they completed several experimental tasks and were familiar with the
labels. Again, the question was elicited on a 5-point-Likert-scale from “Absolutely essential”
to “Not important at all”.
Figure 35 displays the rating of the importance of label elements for the Status Quo Label of
the laundry detergent. The patterns are in accordance with the previous results. It can be found
that CLP- and Detergent relevant elements received ratings well above 70%. The weblink
to receive the full ingredients list was rated absolutely essential or very important by 50% of
the participants and supplier contact information by 45%. The lowest rating again may be found
for marketing information. Only 25% of the participants rated this type of information as
absolutely essential or very important.
40%
38%
38%
41%
38%
43%
35%
34%
8%
43%
16%
29%
34%
36%
34%
33%
34%
30%
34%
40%
19%
34%
25%
33%
16%
18%
18%
16%
17%
16%
19%
19%
34%
15%
28%
25%
4%
4%
4%
6%
6%
5%
6%
4%
20%
4%
16%
8%
3%
3%
3%
3%
3%
4%
4%
2%
17%
3%
13%
5%
2%
2%
2%
2%
2%
2%
2%
1%
3%
2%
2%
2%
0% 20% 40% 60% 80% 100%
Statements to prevent adverse effects
Statements on precautions
Statements on products hazards
Signal word
Hazard pictogram
Information relevant in case of intoxication
List of ingredients
Quantity
Marketing information
Instructions for use
Supplier contact information
Name of the product
Absolutely Essential Very Important Of Average Importance
Of Little Importance Not Important At All Don’t know
121
Figure 35: Rating of Importance of Label Elements With Label (Status Quo Label, Laundry Detergent)
Notes: The question was: “Looking at this label, how important do you rate having the following pieces of
information?”.
Number of observations: N=670
Source: ConPolicy analysis of the experiment and survey data.
Figure 36 displays the rating of the importance of label elements for the Status Quo Label of
the glue. Again, the results are in accordance with the previous results. While CLP-relevant
information such as hazard and precautionary statements or the pictogram received shares of
above 80% (absolutely essential or very important), marketing information was rated less
relevant. Only 26% of the participants indicated that it is absolutely essential or very important.
41%
35%
36%
40%
37%
41%
18%
34%
27%
8%
32%
38%
16%
24%
41%
40%
44%
39%
41%
38%
32%
39%
43%
17%
47%
41%
29%
32%
13%
18%
14%
15%
17%
15%
33%
21%
22%
30%
17%
16%
31%
27%
3%
4%
4%
3%
3%
3%
11%
4%
4%
29%
3%
2%
17%
11%
1%
1%
1%
1%
1%
1%
4%
1%
2%
13%
0%
0%
5%
5%
2%
2%
2%
2%
2%
2%
2%
2%
2%
3%
2%
2%
2%
1%
0% 20% 40% 60% 80% 100%
Statements to prevent adverse effects
Statements on precautions
Statements on products hazards
Signal word
Hazard pictogram
Information relevant in case of intoxication
Weblink to receive full ingredients list
List of ingredients
Quantity
Marketing information
Dosage recommendations
Instructions for use
Supplier contact information
Name of the product
Absolutely Essential Very Important Of Average Importance
Of Little Importance Not Important At All Don’t know
122
Figure 36: Rating of Importance of Label Elements With Label (Status Quo Label, Glue)
Notes: The question was: “Looking at this label, how important do you rate having the following pieces of
information?”
Number of observations: N=670
Source: ConPolicy analysis of the experiment and survey data.
Hence, the results are confirmative and show that CLP- and Detergent-relevant label
elements are perceived as very important by consumers.
Conclusion
Taken the results together it can be shown that label elements that support consumers with the
safe use of chemical substances, i.e. hazard and precautionary information, are essential.
Furthermore, aspects relevant under Detergent regulation, e.g. dosage instructions, are
perceived as essential. Marketing information, on the other hand, systematically stands out as
less important. The later aspect should also be discussed in the light of results from the first
research question, where consumers indicated that marketing information is less
understandable and easy to find on packaging. In general, this result appears not to be
problematic as marketing information is not necessary for consumers’ understanding of safe
use and therefore, there exists no objective need for improvement. Nevertheless, in practice
marketing information takes a lot of space on the packaging of chemical products and therefore,
competes with the space available for CLP-relevant information which is rated as more
important by consumers.
RQ 3: How do consumers interpret labels with respect to hazards and safe use
instructions?
The third research question regards the interpretation of labels given provided information.
Therefore, several questions were included in the experiment. The first set of questions
focussed on the products’ risk perception while the second investigated behaviour induced
by the labels.
51%
48%
46%
50%
49%
48%
42%
22%
8%
52%
20%
26%
36%
38%
39%
36%
35%
33%
36%
37%
18%
34%
27%
33%
9%
10%
11%
9%
11%
13%
16%
28%
33%
10%
30%
25%
1%
1%
2%
2%
2%
3%
4%
9%
25%
1%
16%
11%
1%
0%
0%
0%
1%
1%
1%
3%
13%
1%
5%
4%
2%
2%
2%
2%
2%
2%
2%
2%
3%
2%
2%
2%
0% 20% 40% 60% 80% 100%
Statements to prevent adverse effects
Statements on precautions
Statements on products hazards
Signal word
Hazard pictogram
Information relevant in case of intoxication
List of ingredients
Quantity
Marketing information
Instructions for use
Supplier contact information
Name of the product
Absolutely Essential Very Important Of Average Importance
Of Little Importance Not Important At All Don’t know
123
Risk Perception Induced by Label
The experiment design included two different products that differed in their degree of
potential harmfulness. Among other aspects, the labels at display differed in the amount of
GHS-pictograms presented (one versus three), the signal word (“warning” versus “danger”) as
well as the amount and severity of the included hazard and precautionary statements. More
information on the product specifics may be found in the methodology section.
Risk perception was investigated by three different questions, i.e. on the general risk
perception of use, risk following wrong application as well as risks attached to different
hazards. It must be noted that the purpose of the questions was not to interpret the average
rating of each of the products, i.e. it is not relevant whether a laundry detergent or glue is
perceived as “dangerous” or “harmless”. The questions aimed at investigating whether
displayed information causes participants to rate the glue as more harmful than the laundry
detergent. Hence, the analysis aims at comparing the ratings by product type.
Risk Perception of Use
The question on general risk perception of use was elicited on a 5-point-Likert-scale ranging
from “very dangerous” to “completely harmless”. Figure 37 shows the results by product type.
It can be seen that the glue indeed was rated as more dangerous than the laundry detergent. For
the glue 39% of the participants indicated the product to be very dangerous while the share
for the laundry detergent is only 9%. The difference in danger ratings between the two
products is highly statistically significant (p<0.001).
Figure 37: Risk Perception of Use by Product (Status Quo Label)
Notes: The question was: “In general, how dangerous do you rate using this product?”
Number of observations: N=670 (LD), N=670 (G)
Source: ConPolicy analysis of the experiment and survey data.
Subsequently, participants rating product use as very or somewhat dangerous were asked to
indicate their reasons for their danger perception. Figure 38 displays the replies by product.
It can be seen that for both products the hazard and precautionary statements on the label
were the most relevant reason for rating the product as dangerous (69% for both product
types). Similarly, the hazard pictograms were rated as relevant information for indicating
9%
39%
38%
42%
35%
13%
12%
3%
1%
0%
4% 3%
0%
20%
40%
60%
80%
100%
Laundry Detergent Glue
Very dangerous Somewhat dangerous
Neither dangerous nor harmless Rather harmless
Completely harmless Don't know
124
the products to be dangerous (56% for both product types). The ingredients contained in the
product were a reason for 37% of the participants, while only 17% and 10% named other
information and personal experience.
Figure 38: Reasons for Risk Perception by Product (Status Quo Label)
Notes: The question was: “You indicated that you rate using this product as somewhat or very dangerous. Why?”
(multiple answers)
Number of observations: N=313 (LD), N=543 (G)
Source: ConPolicy analysis of the experiment and survey data.
Hence, the results show that under current regulation (Status Quo Label) consumers were
indeed able to interpret the provided information correctly and attached more risk to an
objectively riskier product. The result confirms findings from the comparative choice task (see
section on the first research question). Furthermore, consumers indicated that CLP-relevant
information contained on the labels causes this perception.
Risk Perception of Wrong Application
The question on general risk perception of wrong application was elicited on a 5-point-Likert-
scale ranging from “very dangerous” to “completely harmless”. Figure 39 shows the results by
product type. Again, consumers rated the wrong application of the products differently. For the
glue 44% indicated wrong use as very dangerous while the share for the laundry detergent
was only 15%. The difference between product variants is statistically highly significant
(p<0.001).
1%
0%
40%
18%
11%
71%
58%
2%
2%
31%
16%
7%
65%
53%
0% 20% 40% 60% 80%
Don't know
Other
Because I identified some of the
ingredients to be harmful for my
health or the environment
Because of other information I
have received/found
Because of my personal
experience and use of the product
Because of the text on hazards or
precautions displayed on the label
Because of the hazard pictograms
displayed on the label
Laundry Detergent Glue
125
Figure 39: Risk Perception of Wrong Application by Product (Status Quo Label)
Notes: The question was: “In general, how dangerous do you rate the wrong application of this product, e.g.
when an accident occurs?”
Number of observations: N=670 (LD), N=670 (G)
Source: ConPolicy analysis of the experiment and survey data.
Hence, it can be concluded that labelling information induces the correct perception of
application dangers as well.
Risk Perception of Different Hazards
Lastly, a question on the risk perception of different specific hazards was elicited. It focused
on risks attached to the product getting into eyes or being inhaled or swallowed. Again, a 5-
point-Likert scale ranging from “very dangerous” to “completely harmless” was used.
Figure 40 displays the results by hazard category and product. For all categories the glue was
on average rated as more dangerous (p<0.001). Furthermore, the rating of product getting into
eyes was comparatively large for both product types. This is in accordance with the actual
information displayed on the labels, i.e. a specific hazard statement is included on the
packaging. Dispersing the product into the water systems or the environments was rated more
threatening for the glue. Again, this is in accordance with the information contained on the
specific labels, i.e. specific hazard statement as well as a GHS pictogram included on the
packaging. The same applies to the products being used next to fire, where the glue received a
higher rating than the laundry detergent. Similarly, a reason for this difference might be the
actual hazard statements and GHS pictogram included on the packaging (the glue was
constructed to be flammable while the laundry detergent was not).
15%
44%
53%
42%
19%
9%
7%
2%
1% 0%
4% 3%
0%
20%
40%
60%
80%
100%
Laundry Detergent Glue
Very dangerous Somewhat dangerous
Neither dangerous nor harmless Rather harmless
Completely harmless Don't know
126
Figure 40: Risk Perception of Different Hazards by Product (Status Quo Label)
Notes: The question was: “From your reading of the label, please rate how dangerous each of the following would
be:”
Number of observations: N=670 (LD), N=670 (G)
Source: ConPolicy analysis of the experiment and survey data.
Additionally, it may be concluded that consumers not only correctly interpret the general risk
of products, but also specific risks that may differ by product.
Behaviour Induced by Label Information
The second set of questions focussed on the behaviours induced by label information. It
included questions on the motivation to read and follow instructions, behaviour in case of
an accident as well as on dosage behaviour.
It must be noted that objectively there are no wrong answers for these questions. Nevertheless,
from a policy perspective reading the information on package is relevant to avoid adverse
effects or dose the product correctly, whereas the need to ask other people for help or consulting
external sources would be less desirable. Similarly, bringing the packaging to a doctor or
applying first aid measures in the case of an accident could be interpreted as positive, while the
71%
71%
42%
42%
16%
36%
74%
14%
54%
13%
12%
5%
21%
56%
19%
19%
42%
38%
38%
45%
18%
19%
29%
35%
22%
17%
45%
34%
5%
6%
10%
12%
28%
13%
5%
26%
7%
28%
28%
30%
19%
6%
3%
2%
2%
3%
11%
3%
1%
16%
3%
10%
18%
23%
8%
1%
0%
1%
1%
1%
5%
1%
1%
14%
1%
6%
12%
20%
3%
1%
2%
2%
3%
4%
4%
3%
2%
12%
5%
7%
8%
5%
3%
2%
0% 20% 40% 60% 80% 100%
If it was used next to open fire
If the product was inhaled or
swallowed
If the product was dispersed into
the environment
If the product got into the
water/sewage system
If the product got onto surfaces
If the product got onto skin
If the product got into eyes
Glue
If it was used next to open fire
If the product was inhaled or
swallowed
If the product was dispersed into
the environment
If the product got into the
water/sewage system
If the product got onto surfaces
If the product got onto skin
If the product got into eyes
Laundry Detergent
Very dangerous Somewhat dangerous
Neither dangerous nor harmless Rather harmless
Completely harmless Don't know
127
need to additionally consult a search engine would indicate that information on the packaging
is not sufficient.
Motivation to Read and Follow Instructions
Results regarding consumers’ motivation to read and follow instructions may be found in
Figure 41. The results show that over 80% of the participants (regardless of product) would
indeed read the label and follow the relevant instructions on dosage, use and precautions.
Trying to find further information only applies to 37% of the participants and asking for
further help either from relatives or friends or the retailer is only applicable to 19% and 22%
respectively.
Figure 41: Motivation to Read and Follow Instructions by Product (Status Quo Label)
Notes: The question was: “Does this label motivate you to:”
Number of observations: N=670 (LD), N=670 (G)
Source: ConPolicy analysis of the experiment and survey data.
84%
85%
85%
21%
16%
28%
24%
38%
84%
80%
81%
84%
12%
14%
16%
15%
36%
81%
11%
10%
10%
69%
71%
62%
65%
50%
11%
14%
14%
11%
79%
77%
75%
74%
54%
13%
5%
5%
5%
10%
12%
10%
11%
12%
5%
6%
5%
5%
9%
10%
10%
11%
10%
5%
0% 20% 40% 60% 80% 100%
Follow instructions to prevent
adverse effects
Follow instructions on use, storage
and disposal
Follow instructions for application
and dosage
Not use the product
Return the product
Ask a retailer for help
Ask a relative or friend for help
Try to find further information
Read the label
Glue
Follow instructions to prevent
adverse effects
Follow instructions on use, storage
and disposal
Follow instructions for application
and dosage
Not use the product
Return the product
Ask a retailer for help
Ask a relative or friend for help
Try to find further information
Read the label
Laundry Detergent
Yes No Don't know
128
In conclusion, results show that consumers are motivated to apply appropriate steps related
to labelling information. Especially reading the label and following instructions appears to
be relevant whereas there is no indication that provided information was insufficient and
consumers would need further information or help.
Behaviour in Case of an Accident
Results regarding consumers’ behaviour in case of an accident are displayed in Figure 42. The
results show that consumers indeed would be willing to take appropriate actions. The
majority indicated performing first aid measure, bringing the packaging to the doctor and
calling a doctor. In contrast, only 11% indicated that they would need to consult further
sources, i.e. via a search engine or the website of the manufacturer.
Figure 42: Behaviour in Case of an Accident by Product (Status Quo Label)
Notes: The question was: “Imagine an accident occurs while using this product. This could be that you or a
member of your household swallows the product or the product splashes into someone’s eyes. What would you
do? (Select all that apply)”
Number of observations: N=670 (LD), N=670 (G)
Source: ConPolicy analysis of the experiment and survey data.
The results confirm previous findings and show that consumers would take the appropriate
measures in case of an accidents. Furthermore, they did not indicate a need for further
information by consulting additional resources.
3%
4%
1%
0%
11%
72%
63%
11%
47%
38%
53%
3%
2%
0%
1%
10%
72%
54%
11%
51%
36%
49%
0% 20% 40% 60% 80%
Don't know
All of the above
None of the above
Other
Consult the internet
Perform first aid measures
Bring packaging or picture of label
to doctor
Consult website of manufacturer
Read label instructions
Call a poison centre
Call a doctor
Laundry Detergent Glue
129
Dosage Behaviour
As highlighted before, there is no “good” or “bad” behaviour when it comes to dosing the
product. Nevertheless, dosage information following legislation considers several relevant
aspects such as the water hardness and degree of soiling that determine the optimal amount of
a product. Furthermore, tools such as a measuring cup or the product lid are helpful in order to
avoid over-dosing. On the other hand, measuring from experience would only be appropriate
if a consumer uses a product that he/she used before (and already considered relevant dosage
information).
Figure 43 displays the results on dosage behaviour for the laundry detergent.34
Results show
that indeed relevant measures were claimed to be taken by at least 40%, whereas only 25%
of the participants would rely on their personal experience of using such a product. Lastly,
only 1% of the participants indicated to take none of the presented actions.
Figure 43: Dosage Behaviour for Laundry Detergent (Status Quo Label)
Notes: The question was: “Imagine you would like to use this product. Which aspects do you consider and which
tools would you use when dosing the product? (Select all that apply)”
Number of observations: N=670
Source: ConPolicy analysis of the experiment and survey data.
Again, results demonstrate that consumers would follow relevant instructions included in the
dosage table of a product. Therefore, both water hardness as well as degree of soiling would
be considered. Similarly, consumers indicated that they would measure the product by using a
tool instead of basing their decision on experience alone.
Conclusion
Taken the results on the third research question together consumers are (subjectively) able to
interpret chemical labels under the current legislation/regulations. They draw appropriate
34
Dosage behaviour was not elicited if a participant was assigned to the glue treatments.
3%
4%
1%
25%
51%
49%
50%
49%
42%
0% 20% 40% 60%
Don't know
All of the above
None of the above
Measure from experience
Use lid
Use measuring cup
Consider the amount of laundry
Consider degree of soiling
Consider water hardness
130
conclusions from the given information at display, i.e. the questions on risk ratings uniformly
show that consumers attach more risk to an objectively riskier product. Furthermore, they are
able to interpret specific label elements on hazards and process them correctly. In addition, the
results show that CLP-relevant label elements are the ones consumers base their perception on,
i.e. the GHS pictogram as well as hazard and precautionary statements. In the light of the
second research question on the importance of labelling elements, results are confirmative.
Hence, consumers not only rate CLP elements as important but also base their risk perception
on them.
Next to the interpretation of labels it is also important that labelling induces appropriate
behaviour. Hence, labelling should be constructed so that consumers take the correct measures
in case of an accident and it should be assured that no further information is lacking. The results
show that indeed consumers would take appropriate measures and do not indicate a need
for further information or help. Additionally, consumers are motivated to read instructions
and consider dosage aspects as instructed. It must be noted that results are not based on actual
behaviour but rather self-reported. Nevertheless, it is in the best interest of consumers to follow
instructions in order to promote safe use and prevent adverse effects that may arise from
chemical substances.
RQ 4: Does label simplification and the introduction of digital tools positively or
negatively affect consumers’ understanding and perceptions?
The fourth research question aimed at investigating whether labels could be simplified. As
described in the methodology section based on desk research a third treatment was introduced
that was a simplification of the Status Quo Label. While most CLP-related information was
maintained, certain aspects were reduced and moved to a website that could be accessed via a
QR code. In the following, we refer to the third label as Simplified Label with QR Code and
investigate how it performs compared to the No Label Baseline as well as the Status Quo Label.
Therefore, several questions on understanding as well as consumer perceptions are presented.
Objective Understanding
The first set of questions that aimed at investigating the performance of the different labelling
treatments regarded the objective understanding of label information. Therefore, participants
were asked to reply to three objective questions on hazards, precautions as well as
ingredients that applied to the products.
Figure 44 displays the results for product hazards. 55% of the participants in the Simplified
Label treatment of the laundry detergent were able to correctly answer the question on
hazards. The share of correct answers in the Status Quo treatment was 54% and in the No Label
Baseline 8%. When comparing performance by treatment the difference between the
Simplified Label and No Label Baseline is highly statistically significant (p<0.001).
Performance between the Simplified and Status Quo Label on the other hand is not (p=0.61).
The same pattern may be observed for the glue. In the Simplified Label treatment 28% of the
participants answered the question correctly, in the Status Quo Label treatment the share was
29% and for the No Label Baseline it was only 6%. Again, the difference between the
Simplified and Status Quo Label is not significant (p=0.79) while it is highly significant for the
Simplified Label and the No Label Baseline (p<0.001).
Figure 44: Objective Understanding of Product Hazards by Treatment
131
Notes: The question was: “Please select all statements that are true about the product displayed on the left:”
(Status Quo Label & Simplified Label (QR)) and “Thinking about a [laundry detergent / glue], please select all
statements that are usually true about such a product:” (No Label Baseline).
Number of observations: N=2,001 (LD), N=2,002 (G)
Source: ConPolicy analysis of the experiment and survey data.
Furthermore, data reveals that 75% of the participants assigned to the Simplified Label of the
laundry detergent zoomed in on the label. Of those who took a closer look 70% answered the
question on hazards correctly, while the share of correct answers among those who did not
zoom was only 11%. The difference between the groups is statistically highly significant
(p<0.001). The same pattern emerges for the glue. Overall, 80% of the participants in the
Simplified Label treatment zoomed in on the label. Among those who zoomed the share of
correct answers was 34%, while it was only 5% among those who did not take a closer look at
the label. Again, the difference is highly statistically significant (p<0.001).
Overall, participants in the Simplified Label treatment of the laundry detergent spent on
average 78 seconds to answer the question on hazards. For those assigned to the glue the
average was 89 seconds. Furthermore, the data reveals that there exists a positive and
significant correlation between time spent on the question and performance (0.43 for the
laundry detergent and 0.41 for the glue, both p<0.001).
Figure 45 displays the results for precautionary statements that apply to the products. As can
be seen on the left (laundry detergent), the share of participants who correctly answer the
question in the Simplified Label treatment was 15%. For the Status Quo Label it was 17%
and for the No Label Baseline 1%. The difference between the Simplified Label and the No
Label Baseline is highly statistically significant (p<0.001), while it is not when comparing the
Simplified and the Status Quo Label (p=0.31).
The same picture emerges when considering the glue (right side of the figure below). 11% in
the Simplified Label treatment answered the question correctly. The share for the Status Quo
Label was 12% and for the No Label Baseline it was 0%. The difference between the Simplified
Label and the No Label Baseline is again highly statistically significant (p<0.001), while it is
not when comparing the Simplified and Status Quo Label (p=0.61).
Figure 45: Objective Understanding of Precautions by Treatment
54% 55%
8%
29% 28%
6%
0%
10%
20%
30%
40%
50%
60%
Status Quo
Label
Simplified
Label (QR)
.
.
No Label
Baseline
Status Quo
Label
Simplified
Label (QR)
.
.
No Label
Baseline
Hazards (Percentage Correct)
Laundry Detergent Glue
132
Notes: The question was: “From your reading of the label, when using this product would you: (Select all that
apply)” (Status Quo Label & Simplified Label (QR)) and “When using a [laundry detergent / glue] would you:
(Select all that apply)” (No Label Baseline).
Number of observations: N=2,001 (LD), N=2,002 (G)
Source: ConPolicy analysis of the experiment and survey data.
With respect to taking a closer look at the Simplified Label (zooming) the following results
emerge: In the Simplified Label treatment of the laundry detergent 64% of the participants
zoomed in on the label. Of those who zoomed 22% answered the question on precautionary
statements correctly, while the share of those who did not take a closer look was only 2%
(difference statistically significant, p<0.001). Similarly, 68% in the Simplified Label treatment
of the glue zoomed in on the label. Among those participants who took a closer look 16%
answered the question correctly and among those who did not zoom the share was 1%
(difference statistically significant, p<0.001).
Furthermore, the time spent to answer the question was on average 53 seconds for the laundry
detergent and 69 seconds for the glue. The more time participants spent to answer the question,
the higher were chances of answering the question correctly (correlation 0.37 for laundry
detergent and 0.31 for glue, both p<0.001).
Lastly, Figure 46 displays the results for ingredients contained in the laundry detergent.
Participants in the Simplified Label treatment answered the question correctly in 36% of the
cases. The share of correct answers in the Status Quo Label treatment was 41% and in the No
Label Baseline it was 10%. Performance in the Simplified Label treatment was significantly
better than in the No Label Baseline (p<0.001). Similarly, performance in the Status Quo Label
treatment was weakly, significantly better than in the Simplified Label treatment (p=0.05).
Nevertheless, the effect size of the performance is negligible (Cohen’s d = 0.11).
17%
15%
1%
12% 11%
0%
0%
10%
20%
30%
40%
50%
60%
Status Quo
Label
Simplified
Label (QR)
.
.
No Label
Baseline
Status Quo
Label
Simplified
Label (QR)
.
.
No Label
Baseline
Precautions (Percentage Correct)
Laundry Detergent Glue
133
Figure 46: Objective Understanding of Product Ingredients by Treatment
Notes: The question was: “From your reading of the label, which ingredients are contained in this product?
(Select all that apply)” (Status Quo Label & Simplified Label (QR)) and “From you experience with laundry
detergents which ingredients are usually contained in such a product? (Select all that apply)” (No Label
Baseline).
Number of observations: N=2,001
Source: ConPolicy analysis of the experiment and survey data.
Information regarding the ingredients was not included on the actual packaging of the
Simplified Label but only could have been accessed via the QR code and the corresponding
website (pop-up to be shown on screen). Overall, 63% of the participants accessed the website
with the ingredients list. Among those who accessed the website the share of answering the
question on ingredients correctly was 54% while it was only 4% for those who did not access
the website (p<0.001). Hence, consulting information enhances objective understanding by
consumers.
Furthermore, participants on average took 48 seconds to answer the question. Again, there
exists a positive and significant relationship between time spent to answer the question and
performance (0.38, p<0.001).
In conclusion, the data shows that the Simplified Label with a QR Code performs
significantly better than the No Label Baseline, i.e. receiving relevant information induced
consumers to better understand safe use information compared to simply answering on
experience with chemical products. Furthermore, the Status Quo Label and the Simplified
Label perform equally with respect to hazards and precautions. Objective understanding of
the ingredients contained in the product was – at least weakly significantly – worse in the
Simplified Label treatment compared to the Status Quo Label, but the effect size was
negligible. An explanation for this could be that ingredient information in the Simplified Label
treatment was moved to a separate website to be accessed via a QR-code (pop-up on screen).
Accessing this website might be causing additional effort on the side of the consumer and
hence, not taking this further step on average negatively affects objective understanding.
Lastly, the data on actively consulting the label, i.e. zooming, confirms previous results. The
majority of participants were willing to take a closer look at the label in the experiment and
if they consulted the label their understanding was also better than when they did not consult
the label.
41%
36%
10%
0%
10%
20%
30%
40%
50%
60%
Status Quo
Label
Simplified Label
(QR)
No Label
Baseline
Ingredients
(Percentage Correct)
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Ability to Identify a Potentially Hazardous Product
In addition to the questions on objective understanding, the comparative choice task carried
out in the experiment may be taken as further evidence on consumers’ understanding of
labelling information. Participants were asked to identify the potentially less harmful
product among two.
As described previously for the laundry detergent, the original product was less harmful than
its twin. Figure 47 displays the results by treatment. It can be observed that the majority of the
participants (62%) in the Simplified Label treatment were able to correctly identify the less
harmful product. The share among participants in the Status Quo Label was 64% and in the No
Label Baseline it was 16%. When comparing the treatments with respect to correct answers, it
can be found that the distribution of the Simplified Label and the No Label Baseline is highly
statistically different (p<0.001). The difference between the Simplified Label and Status Quo
Label, on the other hand, is not statistically significant (p=0.46).
Figure 47: Comparative Choice Task Laundry Detergent by Treatment
Notes: The question was: “Please take a look at the two laundry detergents. Taking into consideration the
information available here, which product is less harmful, i.e. less hazardous for human health or the
environment?”. “Don’t know”-category only available for No Label Baseline.
Number of observations: N=4,003
Source: ConPolicy analysis of the experiment and survey data.
Furthermore, the data from the comparative choice task shows that 72% of the participants
zoomed in on both labels displayed on screen. 21% consulted one of the two labels and 8%
did not zoom. Among those who zoomed in on both labels 66% were able to correctly identify
the less harmful product. The share among those who only consulted one of the two labels was
55% and among those who zoomed in on none it was 47% (difference highly statistically
significant, p<0.001).
The comparative choice task for the glue was designed such that the original product was more
harmful than its twin. Hence, correctly interpreting labelling information would lead
participants to choose the twin product. Figure 48 displays the results by treatment. Again, the
majority of participants (69%) in the Simplified Label treatment were able to make the
correct choice. The share for the Status Quo Label is 68% and for the No Label Baseline it is
16%. When comparing the distribution of correct answers by treatment it can be found that the
Simplified Label treatment and the No Label Baseline are highly statistically different
64% 62%
16%
36% 38%
28%
56%
0%
20%
40%
60%
80%
100%
Status Quo Label Simplified Label (QR) No Label Baseline
Comparative Choice:
Laundry Detergent
Original Twin don't know
135
(p<0.001). The difference between the Simplified Label and the Status Quo Label, on the other
hand, is not significant (p=0.77).
Figure 48: Comparative Choice Task Glue by Treatment
Notes: The question was: “Please take a look at the two glues. Taking into consideration the information available
here, which product is less harmful, i.e. less hazardous for human health or the environment?”. “Don’t know”-
category only available for No Label Baseline.
Number of observations: N=4,003
Source: ConPolicy analysis of the experiment and survey data.
With respect to zooming behaviour the data shows that 71% of the participants in the
Simplified Label treatment consulted both labels, 25% consulted one of the two and 5%
consulted none. Among those who consulted both labels, 70% answered the question correctly,
among those who zoomed on one of the two labels the share was 65% and among those who
did not zoom the share was 65% (differences not statistically significant, p=0.24).
In conclusion, the results from the comparative choice task confirm the findings from the
previous question on objective understanding. The Simplified Label performs significantly
better than the No Label Baseline, i.e. having label information allows consumers to make
the correct choice. Similarly, the Simplified Label and the Status Quo Label perform
equally well. Lastly, consumers were willing to consult the label to gather relevant
information and zooming in on the label partially helped consumers to make a better choice.
Rating of understandability and ease to find
As presented in the section on the first research question, consumers rated the Status Quo Label
on average as rather or very easy to understand. Similarly, the individual label elements such
as GHS-pictograms, hazard and precautionary statements were on average rated as rather or
very easy to find on the packaging. In the following the rating of understandability and ease to
find of the Simplified Label with QR-code is presented. Furthermore, the difference between
the two labelling variants is statistically analysed.
The question on understandability was rated on a scale from “very easy to understand” (1) to
“very difficult to understand” (5). The average rating over both products and all information
elements was 2.00 for the Simplified Label which corresponds with “rather easy to
understand”. The average rating of the Status Quo Label was slightly better with 1.94 which
also corresponds with “rather easy to understand”. Although the difference between the
32% 31%
18%
68% 69%
16%
66%
0%
20%
40%
60%
80%
100%
Status Quo Label Simplified Label (QR) No Label Baseline
Comparative Choice:
Glue
Original Twin don't know
136
Simplified and Status Quo Label is weakly statistically significant (p=0.04) the absolute
difference is rather negligible.
The question on ease to find the relevant label elements was rated on a scale for “very easy to
find” (1) to “very difficult to find” (5). The average rating over both products and information
elements was 2.06 for the Simplified Label which corresponds with “rather easy to find”.
The average of the Status Quo Label was slightly better with 2.00 which also corresponds with
“rather easy to find”. Although the difference between the two label variants is weakly
statistically significant (p=0.05), it again appears not very large.
As noted above, the Simplified Label was constructed such that the dosage table on-pack was
reduced and the full table was available on a separate website to be accessed via the QR code.
Furthermore, the list of ingredients was removed from the package label and moved to the QR
code website. Hence, the analysis investigates the ease to find for those two label elements in
more detail and compares the ratings between the Status Quo and Simplified Label. The
average rating of the ease to find the dosage table was 1.70 for the Status Quo Label and 2.10
for the Simplified Label, i.e. “rather easy to find”. Although the difference is statistically
significant (p<0.001), the effect size is low (Cohen’ d = 0.43). Similarly, the ease to find-rating
of the list of ingredients was on average 1.90 for the Status Quo Label and 2.19 for the
Simplified Label. The difference is statistically significant (p<0.001), but again, the effect size
is only small (Cohen’s d = 0.32).
Hence, both the results from subjective understanding and ease to find relevant label elements
show that the Simplified and the Status Quo Label are rated equally well by consumers.
Nevertheless, it must me noted that the rating questions are subjective and self-reported and
hence, the appreciation of the labels could be over-rated by participants. Especially, because
the overall performance in the questions on objective understanding is poor. But both
subjective ratings and objective performance point in the same direction, i.e. the Status Quo
Label and the Simplified Label perform equally.
Conclusion
In conclusion, the results on the fourth research question show that the Simplified Label with
QR code performs significantly better than the No Label Baseline. Hence, providing this
type of labelling information can inform consumers with respect to relevant measures on safe
use. Additionally, the Simplified Label performs equally well as the Status Quo Label, with
the exception of ingredients information where the Status Quo Label performs slightly better.
An explanation for the later finding may be that the effort of receiving ingredients
information is larger for the Simplified Label, i.e. information is moved to a separate website
to be accessed via the QR-code. It must be noted that the experiment was only able to mimic
access behaviour, i.e. opening the QR code in the experiment was comparatively easy and
consumers could access the website as a pop-up directly on screen. In reality consumers would
need to take their smartphone and scan the QR code in order to receive relevant information
which might require more effort. Furthermore, accessing the QR code is only possible for
consumers that own a smartphone and have access to mobile data.
Lastly, both labels are also subjectively rated very positive, i.e. with respect to subjective
understanding and ease to find relevant labelling elements. The Status Quo Label under current
regulation is rated slightly better than the Simplified Label. Nevertheless, the difference is not
great and hence, both labels should be interpreted as equally good.
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RQ 5: Do consumers prefer information to remain on the physical label or to be
communicated via digital tools?
The fifth research question focusses on consumers’ preferences regarding the ways to
communicate CLP- and Detergents-relevant information. As the previous section
demonstrated, both the Status Quo Label under current regulation and the Simplified Label
with a QR code performed equally well with respect to objective understanding of hazards and
precautions. Although the understanding of ingredients and ratings of subjective
understandability and ease to find were slightly lower for the Simplified Label, the results are
not conclusive regarding whether analogue or digital labelling is preferred by consumers.
Hence, the final set of questions asked participants to indicate their willingness to consult
labelling information via different means. Furthermore, participants were asked to choose
between physical and digital communication for CLP- and Detergents-relevant labelling
aspects.
Reading Behaviour
As a first step, participants were asked about their reading behaviour of chemical labels, i.e.
the point in time when they would usually read safety information. Figure 49 displays the
results. The most frequent answers with 44% and 43% respectively indicated reading the label
before first use or before purchase. 33% said to read it when in doubt and 17% every use.
13% indicated to read it in case of an accident and only 8% said not to read the label.
Figure 49: Reading Behaviour of Labels
Notes: The question was: “When do you usually read the safety information on a label of a chemical product such
as a laundry detergent or glue? (Select all that apply)”
Number of observations: N=4,003
Source: ConPolicy analysis of the experiment and survey data.
Hence, the point in time when consumers usually consult labelling information is either at
purchase (before buying the product) or before using the product at home. Hence, the means
of communicating relevant information on safe use, ingredients and dosage should be tailored
to these situations. The share of consulting the label in case of an accident was comparatively
low which might be because not too many consumers “usually” experience accidents with
3%
8%
13%
33%
17%
44%
43%
0% 10% 20% 30% 40% 50%
Don't know
Usually do not read
In an accident
When in doubt
Every use
Before first use
Before purchase
138
chemical products. When looking at the results from the third research question, it can be seen
that consulting the label in case of an accident is indeed a relevant measure to prevent adverse
effects.
Information Channels
The second question focusses on the general willingness to consult chemical labels by
different analogue and digital means. Therefore, participants were asked to indicate whether
they would actively consult label instructions and safe use information via the package label,
different types of websites as well as digital tools such as QR-codes or smartphone apps.
Figure 50 displays the results by information channel. The vast majority of participants (75%)
indicated that they would consult labelling information via the physical packaging. All other
means were less popular. 18% chose the manufacturer’s website, 13% digital tools such as QR-
or barcodes, 11% an online store website and 6% an in-store scanning station or smartphone
app. The percentage of consumers who are willing to consult at least one digital tool is 35%.35
Figure 50: Willingness to Consult Labelling Information via different Information Channels
Notes: The question was: “When purchasing or using a chemical product such as a laundry detergent or glue,
would you actively consult use instructions, information on hazards or precautions via any of the following means:
(Select all that apply)”
Number of observations: N=4,003
Source: ConPolicy analysis of the experiment and survey data.
In conclusion, the results are a first indication that physical labelling is the preferred option.
The vast majority indicated to be willing to consult information via the packaging of the
product. Nevertheless, it must also be noted that approx. one third of the consumers are at
least willing to consider digital means.
Preference for Communicating Label Elements (analogue versus digital)
Following the previous results on the general willingness to consult labelling information via
different means, the subsequent question asked participants to indicate their preference
35
The binary variable groups those consumers who selected either the manufacturer’s website, online store
website, in-store scanning station, digital tools (QR- / barcode), smartphone app or a combination of the digital
tools versus those who did not select any digital tool.
4%
7%
0%
6%
13%
6%
11%
18%
75%
0% 20% 40% 60% 80%
Don't know
None of the above
Other
Smartphone app
Digital tools (QR-/barcode)
In-store scanning station
Online store website
Manufacturer's website
Package
139
between physical and digital labelling for different CLP-related information elements such
as hazard pictograms, ingredients, and instructions for safe use.
Figure 51 shows that for all types of labelling elements the majority of over 80% prefers
physical labelling over digital tools.
Figure 51: Preference for Communicating Label Elements (analogue versus digital)
Notes: The question was: “Thinking of a product label for a chemical product such as a laundry detergent or
glue, how would you like to receive the following product information: You can either choose to have it on the
package label or to access it through / by using a digital tool such as websites, QR-codes or apps. Please select
one answer per row”
Number of observations: N=4,003
Source: ConPolicy analysis of the experiment and survey data.
Furthermore, the question was repeated for ingredients contained in detergent products.
Participants again were asked to choose among physical or digital labelling for a list of specific
laundry detergent ingredients. Again, the results confirm previous findings (see Figure 52). For
all different types of specific ingredients potentially contained in detergents, approx. 80%
preferred the physical label over digital means.
Figure 52: Preference for Communicating Ingredient Information (analogue versus digital)
83%
82%
80%
89%
88%
82%
81%
89%
92%
12%
13%
15%
7%
7%
12%
14%
7%
5%
5%
5%
5%
5%
5%
6%
6%
3%
3%
0% 20% 40% 60% 80% 100%
Statements to prevent adverse
effects
Statements on precautions
Statements on products hazards
Signal word
Hazard pictogram
Information relevant in case of
intoxication
List of ingredients
Dosage recommendations
Instructions for use
On-Package Digital Tool Don't know
140
Notes: The question was: “Thinking of a product label for a laundry detergent in specific, how would you like to
receive the information on certain / some of the ingredients contained in the product:”
Number of observations: N=4,003
Source: ConPolicy analysis of the experiment and survey data.
The findings show that the preferences of consumers are clear. When having the choice
between either analogue or digital means, the analogue communication was strictly
preferred. This holds true for all CLP- and Detergent-relevant labelling elements.
Furthermore, the preference for analogue versus digital labelling was analysed with respect to
two socio-demographic aspects, i.e. age and digital readiness. The preference in favour of
digital labelling is negatively correlated with age (–0.28, p<0.001). Nevertheless, the
correlation is rather low. Furthermore, the preference for digital labelling is positively
correlated with digital readiness (0.25, p<0.001), hence, again rather low.
Conclusion
The results on the fifth research question on the preference between physical and digital
labelling can be summarised as follows: Firstly, the survey data shows that consumers usually
read labelling information either before first use or before purchase. Therefore, all means
of communication should be accessible in both situations, i.e. not only when consumers are at
home but also when they are in the shop deciding upon a product. When considering digital
tools, it is therefore relevant that consumers either have a personal device to access information
or the retailer provides an accessible way to gather information.
Overall, approximately a third of consumers is open to consult labelling information via
digital tools such as websites, scanning stations or their phone. It must be noted that especially
in-store scanning stations as well as specific smartphone apps for labelling information are
currently rather uncommon. Hence, consumers do not have experience with using such tools,
but their general openness shows that at least some would consider them.
Nevertheless, the results demonstrate that when consumers would need to decide between
either physical labelling on the packaging or digital tools, their preferences are clear. The
majority prefers physical over digital labelling when it comes to relevant CLP- and
Detergents-information. A potential explanation could be consumers’ age and their digital
readiness. Nevertheless, the analysis only indicates the effects to be small.
79%
84%
83%
76%
77%
14%
10%
12%
16%
15%
7%
6%
6%
8%
8%
0% 20% 40% 60% 80% 100%
Preservatives
Allergens
Perfumes
Enzymes
Surfactants
On-Package Digital Tool Don't know
141
Assumptions for the estimation of economic impacts
The EU Standard Cost Model has served as the basis for estimating administrative costs to
industry and public authorities. It estimates the costs of reporting as:
Administrative cost = Σ P x Q
P (Price) = Tariff x Time
Q (Quantity) = Number of businesses x Frequency
In relation to the reporting required under the policy options considered here, the costs elements
are:
 Tariff = hour salary for staff;
 Time = hours to perform the activity;
 Frequency = annual expectation for activity;
 Number of businesses = number of duty-holders that have to classify, label, use suitable
packaging and/or notify to poison centres.
The tariff used in all subsequent calculations is 40 EUR/hour, as reported in the Fitness Check
(EC, 2019e) as the hourly rate for a professional. The administrative costs have been calculated
according to the costs accrued by the companies individually where possible. If the total
number of companies affected is not known, the total cost across all companies is shown. The
activities can comprise of one-off and recurrent costs. The one-off costs relate to the initial
adjustment to a new requirement, such as the (re-)classification of substances to consider the
new hazard classes. The recurrent costs encompass the repeated requirements to update, e.g.
CLI notifications. When it comes to costs for administration, including ECHA, a full-time
equivalent was used. The cost of such an FTE, including 19% of over-head costs is equal to
€170,000 per year.
Where possible and accurate to do so the impacts have been assessed quantitatively, otherwise
a qualitative approach has been taken. The impacts have been categorised according to their
direction (Positive (+)/Neutral (o)/Negative (-)), their causation (Direct/Indirect) and their
frequency (One off/Recurrent).
Where appropriate, separate consideration has been given to SMEs compared to larger
companies. In this respect, efforts were made to ensure SME views are represented, for
example, through discussions with relevant European associations (SMEunited, CIHEF) and
separate analysis of cost information provided by SMEs where relevant.
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Annex 5 – The CLP Regulation and other Pieces of
Chemical Legislation
THE CLP REGULATION
Introduction
The CLP is a legal instrument that provides for obligations on duty-holders to classify, label
and package substances and mixtures, and in some cases pertains to articles. However, not all
duty-holders have the same obligations. Downstream users e.g. can use the labelling
information from their supplier provided they do not change the composition of the substance
or mixture that had been supplied to them. Notification to Poison Centres is required only from
importers and downstream users of mixtures.
Figure 53: Breaking down the risk-assessement and hazard communication related parts.
Hazard identification, evaluation and classification
The first step to determine whether a substance or a mixture is hazardous is to identify and
evaluate, based on available data, whether they correspond to the classification criteria as
provided for in Annex I of CLP. In that Annex, each of the hazard classes (e.g. carcinogenicity,
chronic aquatic toxicity) is described with the criteria to be fulfilled and the type of evidence
to be provided, as well as, the category/ies within each hazard class – the latter reflects the
‘severity’ of a hazard (e.g. carcinogenic 1A is more severe than carcinogenic 2). Sometimes,
such evaluation needs to weigh different pieces of evidence against each other (‘weight of
evidence’ approach) and is based on expert judgment. Once the evaluation is performed and it
is concluded that a substance or mixture fulfils the criteria of one or more hazard
classes/categories, the duty-holder has to ‘classify’ its substance or mixture. It may happen
that such classification is warranted only for a particular endpoint (e.g. the inhalation route
only). Classification of substances may be based on ‘self-classification’ or on ‘harmonised
classification’. The latter is possible and required only when a classification has been
143
harmonised, which in practice means that an entry exists in Table 3 of Part 3 of VI to CLP.
That table is regularly updated via the ‘Adaptations to Technical and Scientific progress’ which
are in the form of ‘Commission Delegated Regulations’. Those Regulations group many entries
on which ECHA has delivered an Opinion and which it transmits to the Commission for
decision-making, in accordance with the procedure in Article 37 of CLP.
Hazard communication
Labelling
Once a substance or mixture has been classified, such classification information needs to be
communicated so that each actor in the supply chain is aware of the potential hazards of the
substance or mixture. That communication is usually performed via the label, which displays
hazard pictograms as well as hazard statements and precautionary statements. More detailed
information is provided in the Safety Data Sheets, developed according to the REACH
provisions (in particular Article 31 and Annex II to REACH). In case of harmonised
classification, most of the labelling elements pertaining to the hazards will also be harmonised
and hence duty holders have no choice but applying the labelling information corresponding to
each respective substance included in Table 3 of Part 3 of Annex VI. In case no harmonised
classification exists – which is the case for mixtures and most of the substances - it will be up
to the duty holder to check the labelling information triggered by its classification decision.
Notification to the classification and labelling inventory
CLP also provides for the obligation for manufacturers, importers and downstream users to
notify certain information to ECHA, which will feed into the CLI (database). The inventory
was set up with the view to ensure a harmonised level of protection for the general public (in
particular persons who come into contact with certain substances) and to ensure proper
functioning of legislation relying on classification and labelling. Notifiers need to update their
notifications in case of changed classifications and they are required to make every effort to
come to an ‘agreed entry’, meaning a classification of a substance on which all notifiers agree
- which does not prevent that in certain cases divergent classifications may be justified because
e.g. the presence of an impurity.
Notifications to poison centres
Another aim CLP pursues is to ensure that information on mixtures is available in case of
poisoning accidents. Poison centres will collect the information that is notified to them, which
will enable them to give the most appropriate advice to carers in emergency situations.
Importers and downstream users need to communicate the composition of their mixture which
will feed into the poison centre’s databases (which is either a national database or the EU
database managed by ECHA).
Packaging
CLP contains a number of packaging provisions, to ensure that the packaging of hazardous
substances and mixtures is sufficiently resistant under normal conditions of use. A few generic
provisions are included in the main text of CLP, which refers to more specific provisions which
apply depending on the type of hazards or product (e.g. packaging of substances and mixtures
containing 3% or more of methanol will require a child resistant fastening).
144
The United Nations’ Globally Harmonised System (UN-GHS)
The CLP is based on the UN-GHS classification and labelling system and is implementing it.
The aim is to have globally harmonised classification and labelling rules, in order to allow for
classification and labelling of the same substances and mixtures in the same way at global (UN)
level. It needs to be noted that the UN-GHS is a system that operates through the so called
‘building block approach’, meaning that Members may implement some parts of the UN-GHS
rules or follow a stepwise approach. It also needs to be noted that the UN-GHS harmonises
rules and criteria but there are no ‘UN wide classified substances’ as the actual harmonised
classification process is performed by each member individually and endeavours to come to a
‘global list’ have not been very successful so far.
MAPPING LINKAGE FROM CLP TO OTHER PIECES OF CHEMICALS LEGISLATION
Data generation
Chemical risk assessment involves the analysis of the inherent hazardous properties of a
substance or a mixture and the extent of exposure to that substance or mixture. The human
health and environmental risks related to exposure to hazardous chemicals are addressed via
the hazard and risk assessment procedures and requirements set out in the different key pieces
of the EU chemicals legislation such as the CLP, the Plant Protection Products and Biocidal
Products Regulations, etc. To be noted that, while additional information requirements in
REACH could lead to additional animal testing, there is no data requirement under CLP with
regards animal testing. The decision to classify a substance or a mixture is exclusively based
on existing available information.
Figure 53: Interaction between CLP and other pieces of legislation (from figure 1 in the SWD)
Regulations using hazard identification from CLP
The main steps of a chemical risk assessment involve:
hazard identification (based on toxicity tests and other relevant information);
dose (concentration) – response (effect) assessment;
exposure assessment – exposure scenarios (based on models and measurements of the
occurrence of the chemical);
145
risk characterisation; and
risk estimation.
Risk management measures – which can be policy-based and/or technical in nature - are then
decided in light of the identified hazards and/or risks. Risk management measures can range
from (and involve a mix of) a total ban to any condition to the manufacture, use or placing on
the market of chemicals (such as setting emission/concentration/migration limits, obligations
to communicate hazards and risks, labelling requirements, obligations to use personal
protection equipment, etc.).
Regulations using hazard identification from CLP
There are two basic approaches to risk management often used in combination, in the EU
chemicals acquis: one based on specific risk assessment (SRA) and the other one based on
generic risk considerations (GRC).
The main difference between these two approaches is the point in time when the exposure
assessment is considered and the specificity of the exposure assessment. For risk management
based on GRC, the potential exposures and risks are considered generically, prior to the
adoption of legislation. The GRC-based approach is built into the legislation in the form of an
automatic trigger of pre-determined risk management measures (e.g. packaging requirement,
communication requirement, restrictions, bans, etc.) based on the hazardous properties of the
chemical, without the need or possibility to assess and take into account specific exposure
levels for a specific situation or use. For example, under the Cosmetic Products Regulation any
substance classified as carcinogenic, mutagenic or toxic for reproduction (CMR) categories
1A/B and 2, shall be banned from use in cosmetics (subject to strict derogations), given the fact
that direct exposure of humans is taking place through the application of a cosmetic product on
the external parts of the human body (or teeth or mucous membranes of the oral cavity). Similar
approaches have been taken for active ingredients in plant protection products and biocides,
for substances in toys, etc.
The decision to link particular hazard properties (e.g. CMR, persistent bioaccumulative and
toxic substances (PBT), endocrine disruptors (EDs)) to automatic risk management measures
without the intervening step of a specific risk assessment is done on the basis of generic risk
consideration without prejudice to performing also a full risk assessment for the other
properties of the substances which are not linked to the related hazard properties. In the
legislation evaluated in this Fitness Check, the generic risk consideration approach is typically
applied for the following use applications and the following substances:
Use applications:
when there is a need to obtain and pass on information to enable
[further/specific] risk assessment or risk management (e.g. labelling obligations
under CLP, labelling requirements and use instructions under the Plant
Protection Products and the Biocidal Products Regulations).
for use in widely dispersive or open applications which result in a significant
exposure of humans or the environment (e.g. plant protection products).
for use in applications where the exposure is considered to be more difficult to
control and monitor (e.g. plant protection products).
for use in applications resulting in exposure of vulnerable groups (e.g. children).
146
for use to prioritise the risk assessment of certain chemicals and under certain conditions (e.g.
food contact materials).
Substances:
for substances with hazard properties that result in severe adverse effects on
human health or the environment should exposures occur (e.g. CMR, PBT, EDs,
chemicals with Single Target Organ Toxicity (STOT) properties); and
for substances where it is difficult/impossible to identify a safe threshold and, therefore, where
most specific risk assessments are likely to identify risks that lead to a need for risk
management measures (e.g. PBT, vPvB, respiratory sensitisers).
The Commission Staff Working document on the Fitness Check of the most relevant chemicals
legislation (excluding REACH)36
contains an Annex (Annex 4) that provides a summary of
legislation of hazard/risk assessment chemicals legislation that distinguished between
legislation that relies or not on the hazard assessment according to CLP.
36
COMMISSION STAFF WORKING DOCUMENT FITNESS CHECK of the most relevant chemicals legislation
(excluding REACH), as well as related aspects of legislation applied to downstream industries Accompanying
the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE
EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Findings of the
Fitness Check of the most relevant chemicals legislation (excluding REACH) and identified challenges, gaps and
weaknesses, p 164-178, https://ec.europa.eu/info/sites/default/files/swd_2019_0199_en.pdf .
147
Annex 6 – Summary of the findings of the Fitness
Check on Chemical Regulations (except REACH)
This annex sums up the findings of the Fitness Check performed on the most relevant pieces
of chemical legislation (excluding REACH). Only CLP-relevant findings are reported below.
The development of EU legislation on chemicals started with the adoption of the Dangerous
Substances Directive in 1967, followed by the Dangerous Preparations Directive in 1988,
which were the forerunners of the CLP harmonizing the criteria for classification, labelling and
packaging of substances and mixtures. The CLP identifies hazardous chemicals and provides
criteria how to classify those chemicals (either via self-classification or harmonised
classification). Based on the classification, the CLP provides rules on their labelling and
packaging.
The Commission decided to undertake this Fitness Check to see what elements of the European
chemicals acquis work well and what needs to be improved, both in terms of meeting the policy
objectives and in terms of reducing regulatory burden. An assessment of the CLP framework
is part of that Fitness Check.
Overall, the Fitness Check concludes that EU Chemicals legislation, including CLP, meets its
objectives in terms of hazard assessment and management.
The linkages between the different pieces of EU chemicals legislation are generally well-
established and functioning reasonably well. The EU legal framework on chemicals is
generally designed to make science- and evidence-based decisions. The approach allows it to
deliver in an effective, efficient and coherent way. The added value of policy action at the EU
level is high and remains relevant. Significant benefits in terms of avoided health and
environmental impacts (e.g. healthcare costs, productivity losses, suffering and premature
deaths, remediation costs, and degradation of environmental/eco-system services) could be
registered. Also quality and the availability of data needed to perform robust risk assessments
and to make sound risk management decisions has improved considerably in recent years.
Remaining challenges, gaps and weaknesses identified by the Fitness Check – and relevant for
CLP – are the following:
Implementation and enforcement
The correct functioning of the EU chemicals legislation relies heavily on the availability of the
resources of public authorities in charge of its implementation and enforcement but variations
between the capacity, available resources and expertise of Member States’ competent
authorities present significant challenges for implementation and enforcement and the systems’
overall effectiveness and efficiency.
Resource constraints at national level affect the capacity to carry out different enforcement
activities, such as inspections and other controls including market surveillance activities or
reporting. There is also a considerable lack of information on the level of compliance with the
existing EU chemicals legislation, particularly with respect to consumer products.
148
Duplication, burdens and pace of procedures
Scientific advice and risk assessment are provided to the Commission by different agencies
and scientific committees depending on their areas of intervention and their competencies.
Ensuring good and effective cooperation among the EU agencies and the rules of procedure
governing the functioning of the existing committees is a must and could be improved. The
substance-by-substance approach could be improved as well, especially in view of assessing
chemicals with similar hazard, risk or function as a group a more holistic approach should be
considered.
Communication of hazard and safety information:
A survey found that 45% of correspondents feel well informed about the potential dangers of
chemicals contained in products. The relatively low level of understanding of certain labels
and statements is partly due to the overload of information or to the overlaps in legal
requirements. This makes it difficult for downstream users and consumers to focus on the
essential hazard information. At the same time, the lack of some information on consumer
goods (labelling requirements on environmental hazards for cosmetic products) impacts the
consumers’ ability to make informed choices. The communication of hazard and safety
information to consumers can thus be improved and simplified, including by using digital
technologies such as Q-R codes. Also ECHA’s classification and labelling inventory (C&L)
could be improved so as to reduce the number of different entries for the same substance.
Consistency of risk management measures
A potential important gap is the lack of an overarching approach to the protection of vulnerable
groups. Reference to vulnerable groups is not systematic across the legislation and risks to
these groups are not always addressed in a consistent manner across product, risk, or sector
specific legislation.
Due to different risk management decisions of various legislations, inconsistencies exist for
substances that are endocrine disruptors, persistent, bio-accumulative, toxic, very persistent
and very bio-accumulative and fulfil the classification criteria for specific target organ toxicity.
The potential added value of introducing new hazard classes in the CLP Regulation (e.g.
terrestrial toxicity, neurotoxicity, immunotoxicity, endocrine disruption, persistent
bioaccumulative and toxic, very persistent very bioaccumulative) could be explored.
Risk assessment, knowledge gaps and challenges in keeping up with science
The proper functioning of the EU chemicals legislation and its capacity to respond to future
challenges depends on the ability of the EU and Member States to make their decisions based
on robust and relevant up-to-date data. Important knowledge gaps remain regarding exposure
to hazardous chemicals, their use and their impacts on humans and the environment, including
on biodiversity and ecosystems’ resilience.
Moreover, there are still barriers to the use and acceptance of alternative (non-animal) test
methods for regulatory purposes, partially linked to gaps in the available test guidelines.
Lack of knowledge about substances in articles is increasingly concerning as the EU is in the
process of shifting towards a more circular economy, therefore, a life-cycle assessment is
needed and information on recyclability.
149
Global competitiveness, innovation and sustainability
Globalisation, a strong growth in the production of chemicals in other parts of the world and
rapid technological change are the main challenges for the EU chemicals industry. Significant
efforts will be needed by all interested parties at all levels and most importantly by industry
itself to maintain and reinforce Europe's industrial leadership (main assets of the EU chemicals
industry are a high level of technological development, a skilled and talented workforce and a
world-class science base).
The internal market is another asset that the EU and Member States authorities as well as the
EU industry can build upon such as digitalisation, IT tools and other smart technologies. Smart
technologies offer better communication of chemical hazard and safety information to
consumers and digitalisation means potential burden reduction for SMEs.
Additional support to the development of smart, innovative, and sustainable chemicals and to
encourage ‘green chemistry’ will be critical to ensure sustainability as well as the
competitiveness of the EU chemicals industry for the future.
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Annex 7 – Baseline, discarded measures and
assessment of policy measures
1 BASELINE
The baseline has been defined to allow for the assessment of the environmental, economic and
social impacts of the policy options considered. It includes a brief description of the wider
socioeconomic context, the evolution of the macroaggregates of the EU chemical industry and
the assumptions on the continuation of the existing legal framework and scope. The latter is
described in more detail by the seven intervention areas.
Box 1 – Choice of the appraisal period
The 2023-2042 period (20 years) is considered adequate for the projections under the
baseline scenario and the impact assessment of the proposed options. Its length has been
decided in consideration of the expected time-span for the realisation of impacts: the policy
options considered are expected to entail one-off and recurring costs for businesses and
Member State competent authorities. It is important to stress that even the one-off costs are
expected to be borne gradually over a number of years rather than all in year one: for
example, the costs of classifying and labelling chemical substances and mixtures as
endocrine disruptors depend on a number of factors:
The introduction of information requirements on endocrine disruption in REACH;
The generation of data by REACH registrants through the required testing: some of the tests
require two to three years to generate results;
The quality of the data generated and the follow-up activities by ECHA and Member State
competent authorities to fill data gaps and improve the overall information quality.
Also the benefits and cost savings of the policy options considered are expected to be
obtained over a number of years: while some of the cost savings may be generated relatively
shortly after the implementation of the measures (e.g. benefits accruing from the
improvements to the CLI, changes in the labelling requirements), human health and
environmental benefits of the introduction of new hazard classes to CLP may be obtained
only in the long term. To account for the long latency of some of the relevant health
outcomes, a sensitivity analysis was performed, considering a longer discounting period (40
years).
Finally, the 20-year period is also consistent with the period considered by Ricardo (2021).
Context
1.1.1 Socioeconomic context
The short-term economic outlook for the EU is positive, as the economy is rebounding from
the crisis onset by the COVID-19 pandemic faster than expected. Households’ spending is
recovering but supply’s growth is hindered by labour shortages, challenges in global logistics,
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shortages in the production of key raw materials and microprocessors, and surging energy
prices37
. The OECD long-term projections forecast the GDP of the Euro Area (17 countries) to
pass from USD201513.97 billion (EUR201512.59 billion) in 2020 to USD201518.65 billion
(EUR201516.81 billion) in 2040 (33.5% growth).38
The EU27’s population is projected to increase from 447.7 million in 2020 and peak to 449.3
million in 2026, then gradually decrease to 446.8 million in 204039
. Both the size and the
proportion of older persons in the total population are expected to increase40
, with the share of
elderly persons (65 years and over) projected to grow from 21% in 2020 to 27% in 204041
.
Increasing demographic imbalances42
, such as the ageing population, pose challenges for
public expenditure in relation to pensions, health care and long-term care costs.
Accelerating technological change and hyperconnectivity is also expected to have a strong
influence on all aspects of human life in the next decades. The fifth generation of mobile
connectivity (5G), edge computing, next-generation batteries, precision sensors and quantum
computing are expected to enable innovation, in particular towards human augmentation43
(EY,
2020). This includes empowering consumers through enhanced decision-making thanks to, for
example, easier, faster and more tailored information. New disruptive technologies challenge
existing regulations but may also enable new regulatory approaches.
Climate change and environmental degradation is affecting human activities at multiple
levels: ecosystems’ degradation is decreasing their ability to provide the services on which
human life depend on, such as food, availability of clean water, absorption and retention of
carbon dioxide, clean air and shelter. Climate change is likely to amplify other long-term
driving forces, such as significant migration and social inequalities.
The expanding influence of countries in the East and South of the world, fuelled by their
young populations and growing living standards, is driving the global economy to increased
protectionism, which may result in trade and investment flows becoming more regional. The
37
Autumn 2021 Economic Forecast: From recovery to expansion, amid headwind, available at:
https://ec.europa.eu/info/business-economy-euro/economic-performance-and-forecasts/economic-
forecasts/autumn-2021-economic-forecast-recovery-expansion-amid-headwinds_en
38
GDPVD, Gross Domestic Product, volume in USD, at constant 2015 purchasing power parities. Source:
https://www.oecd-ilibrary.org/economics/data/oecd-economic-outlook-statistics-and-projections/long-term-
baseline-projections-no-109-edition-2021_cbdb49e6-en
2015 Exchange rate 1 USD – 0.9015 EUR. Source: https://www.exchangerates.org.uk/USD-EUR-spot-exchange-
rates-history-2015.html
39
https://ec.europa.eu/eurostat/databrowser/view/proj_19np/default/table?lang=en
40
https://ec.europa.eu/eurostat/statistics-explained/index.php?title=People_in_the_EU_-
_population_projections&oldid=497115
41
https://ec.europa.eu/eurostat/databrowser/view/proj_19np/default/table?lang=en
42
One of the 14 global megatrends — ‘long-term global driving forces that are observable in the present and are
likely to continue to have a significant influence for a few decades’ — monitored by the European Commission
and regularly used in foresight exercises. The other 13 are: accelerating technological change and
hyperconnectivity, aggravating resource scarcity, changing nature of work, changing security paradigm, climate
change and environmental degradation, continuing urbanisation, diversification of education and learning,
widening inequalities, expanding influence of East and South, growing consumption, increasing demographic
imbalances, increasing influence of new governing systems, increasing significant migration, shifting health
challenges. Source: https://knowledge4policy.ec.europa.eu/foresight/tool/megatrends-hub_en
43
Gartner, Human Augmentation, ‘Cognitive and physical improvements as an integral part of the human body’.
152
pandemic has also exposed the fragility of the global supply chains, which is encouraging
companies — but also governments — to explore more resilient systems.
1.1.2 The chemical industry
The EU27 chemical manufacturing industry accounts for approximately 7% of the total EU
industrial production (EC, 2019e). In 2020, chemical production dropped by 1.9% compared
to 2019 levels, but it is expected to bounce back in 2021 (expected growth of 3%) and 2022
(2% growth). The long-term response of the industry to the economic impacts of the COVID-
19 pandemic remains uncertain.44
Chemical sales accounted for €499 billion, contracting by
8.1% (€44 billion). The EU share of global sales continue to decrease (from 19.3% in 2010 to
14.4% in 2020, and projected to be 10.5% in 2030), but the global chemicals market is expected
to keep growing markedly (from €3.5 trillion in 2020 to €6.2 trillion in 2030) resulting in an
absolute growth of EU sales between 2020 and 2030 of around 30% (from €499.1 billion to
€651 billion). The industry spent €9.4 billion in R&I (around 7.4% of added value).45
Table 9 provides an overview of the main economic aggregates (turnover, value added at factor
cost, number of enterprises and number of persons employed) of the chemical sector
(manufacturers, formulators and distributors):46
around 57,000 companies contributing roughly
to €309 billion in Gross Added Value and employing over 1.6 million people. Chemicals are
used in all aspects of modern life, and virtually all manufacturing sectors and many downstream
sectors rely on chemical products, from agriculture to automotive and aerospace. The industry
generates over 3.6 million indirect jobs.47
Table 9: Forecast of main aggregates for C20 Manufacture of chemicals and chemical products; G46.12
Agents involved in the sale of fuels, ores, metals and industrial chemicals; G46.75 Wholesale of chemical
products
2018 2020 2032 2042
C20 Manufacture of chemicals and chemical products
Enterprises - number 27,986 28,168 31,469 34,221
Turnover or gross premiums written - million euro 600,000 588,578 735,051 857,111
Value added at factor cost - million euro 130,000* 146,077 221,768 284,843
Persons employed - number 1,200,000 1,147,873 1,288,314 1,405,349
G46.12 Agents involved in the sale of fuels, ores, metals and industrial chemicals & G46.75 Wholesale of
chemical products
Enterprises - number 43,413 41,337 30,591 21,636
Turnover or gross premiums written - million euro 198,268 200,906 205,727 209,744
Value added at factor cost - million euro 20,381 22,763 31,003 37,869
Persons employed - number 248,356 247,995 265,618 280,303
Source: Eurostat Annual detailed enterprise statistics for industry (NACE Rev. 2, B-E) – 2018 data
Notes: *2017 data; cells in light blue are linear forecasts based on Eurostat 2011-2018 values
SMEs account for 96.7% of the number of enterprises in the chemical manufacturing sector
and 16.1% of the total turnover (Eurostat data).
44
CEFIC, Facts and Figures of the European Chemical Industry, 2022.
45
See CEFIC above.
46
It should be noted that many other companies categorised by Eurostat with other NACE codes may have CLP
duties. In other words, there may be companies which primary business activity is e.g. the ‘manufacture of rubber
and plastic products’ and therefore included in NACE code C22, that may have to classify substances and label
and package chemical products according to CLP requirements.
47
SWD(2019) 199.
153
Baseline by policy area
The baseline, or ‘no-policy-change’ scenario assumes the realistic implementation and
enforcement of the existing legislation. The following subsections describe the key
assumptions on the policies and measures contained in the baseline. These are presented by the
seven intervention areas identified for the revision of the CLP Regulation:
Area 1: Hazard identification;
Area 2: Toxicity reference values and harmonised classification and labelling;
Area 3: Classification and Labelling Inventory and self-classification;
Area 4: Labelling;
Area 5: CLP scope exemptions;
Area 6: Online sales;
Area 7: Poison centre notifications.
1.1.3 Area 1: Hazard identification
As explained in Section 2, CLP is the horizontal reference point for the identification and
classification of the physical, health and environmental hazards of chemical substances and
mixtures for most EU chemicals and chemicals-related legislation. However, the hazards
defined under CLP — and the UN GHS — are not exhaustive, resulting in lack of
communication on the hazards not covered by CLP.
As CLP does not contain hazard identification criteria for substances with ED, PBT/vPvB and
PMT/vPvM properties, under the baseline these substances will keep being identified through
REACH (ED, PBT/vPvB and PMT/vPvM substances), BPR and PPPR (ED, PBT/vPvB
substances). The BPR and the PPPR have established identification criteria for EDs. While
REACH does not contain identification criteria for EDs, these can be identified as SVHCs on
a case-by-case basis following the IPCS/WHO definition and the assessment of the “equivalent
level of concern” carried out by the REACH Member State Committee. REACH requires
registrants to carry out a PBT assessment for substances placed on the market in quantities of
10 tonnes or more per year. Any substance under the scope of REACH can be identified
according to the criteria listed in Annex XIII of REACH as PBT or vPvB and, as for EDs, may
be identified as SVHCs (article 57 of REACH). The BPR refers to REACH Annex XIII criteria,
and the PPPR contains PBT/vPvB identification criteria. Neither REACH nor any other
legislative framework have identification criteria for substances with PMT/vPvM properties,
but they can be identified as SVHCs under REACH.
ECHA’s integrated regulatory strategy brings together the various regulatory processes of
REACH and CLP. It is based on the efficient selection of substances and groups of substances
that raise potential concern, so that information needed to assess their safety is generated and
any remaining concerns addressed through the most suitable regulatory risk management
measures. ECHA and MSCAs carry out the following substance-specific activities: data
generation and assessment (dossier evaluation, substance evaluation, informal hazard
assessment of PBT/vPvB/ED properties); assessment of regulatory needs (ARN); and
regulatory risk management (harmonised classification and labelling, SVHC identification,
restriction).48
48
Planned, ongoing or completed activities are listed in the Public Activities Coordination Tool (PACT).
154
Under the baseline, it is assumed that these activities will keep contributing to the identification
of ED, PBT/vPvB and PMT/vPvM substances. The assessment of regulatory needs may be
based on sufficient available information or on data generated on missing hazard information
following compliance checks, testing proposals and substance evaluation. In addition, the ED
and PBT expert groups assuport the identification of ED and PBT/vPvB substances.
ECHA and MSCAs select substances that are to be evaluated to clarify whether their use poses
a risk to human health or the environment. The selection is carried out on the basis of risk-
based criteria. The substances selected for substance evaluation (Chapter 2 of the REACH
Regulation) are included in the community rolling action plan (CoRAP) following the opinion
of the Member State Committee. The evaluation of each substance is carried out by a
designated Member State by assessing all registration dossiers from all registrants specific to
the same substance or group of substances, considering other sources of information and by
requesting and assessing new data from the registrants, typically going beyond the standard
REACH information requirements. Following the assessment of all information, if the
evaluating Member State considers that the use of the substance poses a risk, it may proceed
by proposing: harmonised classification and labelling for certain hazards, identification of the
substance as SVHC, an EU-wide restriction, EU-wide occupational exposure limits, national
measures or voluntary industry actions.
As of February 2022, the CoRAP includes 392 unique substances/entries (Figure 53).49
Between 2012 and 2023, Member States evaluated, are evaluating or plan to evaluate 90
substances for their suspected ED properties and 151 substances for their suspected PBT/vPvB
properties. Additionally, 23 substances are undergoing an ED assessment under the BPR.50
No
data could be found on the number of substances undergoing an ED or PBT/vPvB assessment
under the PPPR.51
So far, no substances have been included in the CoRAP to investigate
suspected PMT/vPvM properties.
49
Note that ECHA webpages may indicate a slightly lower number of substances/entries than those listed in the
downloadable list, also because group entries are split in different rows. Source:
https://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-table
50
https://echa.europa.eu/ed-assessment
51
It should be noted that the review under BPR and PPPR is systematic, but limited to ED category 1.
155
Figure 53: Number of substances with suspected ED or PBT/vPvB properties or other hazards per planned
evaluation year - Note: substances can be evaluated for multiple suspected hazards - Source: CoRAP
Following data generation (or the evaluation of the available information considered sufficient
for the purpose), the regulatory needs of substances and groups of substances are assessed.52
The outcome can be that either there is no need for action or that regulatory risk management
at EU level is required. The follow-up regulatory actions are: harmonised classification and
labelling, SVHC identification, restriction, or action through other EU legislation. The
assessment can also result in a request for additional data (e.g. through substance evaluation).
As of February 2022, the candidate list of substances of very high concern for authorisation
includes 444 entries, of which 113 were included because of their ED properties, 114 because
of their PBT/vPvB properties and 21 because of their PMT/vPvM properties. It is assumed that
Member States or ECHA would keep proposing substances to be identified as SVHCs at the
same rhythm. It should be noted that the group approach may result in higher numbers of
substances being identified as EDs or with PBT/vPvB or PMT/vPvM properties. Substances
and groups of substances can also be identified for restriction rather than authorisation. The
effect of the inclusion of groups of substances could be large: for example, the announced
intention to submit a restriction proposal for PFAS would affect more than 6,000 substances,53
although only around 2,000 are currently registered.54
Finally, biocidal and plant protection
active substances that exhibit ED or PBT/vPvB properties should not be approved, in
52
As of February 2022, the ARN registry (https://echa.europa.eu/assessment-regulatory-needs) lists 754 entries
between substances and groups of substances, for a total of 2,116 substances. In the downloadable spreadsheet,
group entries are split in different rows. However, not all groups are split (e.g. PFAS has one single row) and
therefore the total number of unique substances is larger. The need for regulatory action, if any, can be identified
for the whole group, a subgroup or a single substance.
53
Dutch Ministry of Health, Welfare and Sport, Official start to ban PFAS in Europe, available at:
https://www.rivm.nl/en/pfas/official-start-to-ban-pfas-in-europe
54
ECHA Page on Perfluoroalkyl chemicals (PFAS), available at:
https://echa.europa.eu/hot-topics/perfluoroalkyl-chemicals-pfas
156
principle,55
for their use in biocidal and plant protection products, in accordance with the BPR
and PPPR.56
By forecasting numbers of substances through linear regression using the known values for the
period 2008-2022, in 2032 the candidate list would include 799 substances, of which 206 for
ED properties, 214 for PBT/vPvB properties and 67 for PMT/vPvM properties. In 2042, the
candidate list would include 1,126 substances, of which 293 for ED properties, 306 for
PBT/vPvB properties and 110 for PMT/vPvM properties (Figure 54).
Figure 54: Number of substances included in the candidate list of SVHCs for ED, PBT/vPvB or PMT/vPvM
properties or other hazards per year - Source: ECHA Candidate list (projections of the authors)
As most of the substances may be used in more than one mixture, it is necessary to estimate
the number of mixtures that would be impacted by the identification of a substance with one
or more of the considered properties. Estimating this is difficult for several reasons:
There is no central repository that compiles information on the number of mixtures for
the entire EU;
Some of the possible information sources are not publicly available, such as the information
provided to Poison centres for medical emergency57
or the German Federal Institute for Risk
Assessment (BfR).58
Ricardo (2021) estimated that 16,969 substances (including UVCBs) and 190,702 mixtures
would be impacted by the extension of the generic approach to risk management to the
following hazard classes: ED, PBT/vPvB, PMT/vPvM, respiratory sensitisation Cat. 1, 1A and
55
Derogations are foreseen.
56
The reasons for non-approval of active substances are not easily retrieved from ECHA and EFSA databases, if
not by checking the opinions one-by-one.
57
https://poisoncentres.echa.europa.eu
58
See e.g. https://www.bfr.bund.de/en/notification_of_products-10144.html, accessed November 2021.
157
1B, STOT RE/SE Cat. 1 and 2, immunotoxicity, neurotoxicity, CMR Cat. 2, Skin Sensitisation
Cat. 1, 1A and 1B, aquatic chronic 1 and 2 (Ricardo, 2021, p.50). These estimates imply an
average number of mixtures per substance of around 11.
An alternative estimate was derived by analysing the SPIN (Substances of Preparations in
Nordic Countries) and extrapolating the result to the EU.59
The average of five mixtures per
substance was multiplied by a factor of five for projection to the entire EU, resulting in an
average of 25 mixtures placed on the EU market per single substance. This is consistent with
the estimates in the 2017 Fitness Check, which used figures of 99,000 substances and 2.5
million mixtures subject to reclassification, labelling and safety data sheets preparation to
produce an average of about 25 mixtures per substance.
Applying these two estimates (11 and 25 mixtures per substance) to the numbers of SVHCs in
2022 and the estimated number of SVHCs in 2032 and 2042 produces the estimates for the
total numbers of mixtures in the table below.
Table 11: Estimated number of mixtures containing SVHCs with ED, PBT/vPvB, PMT/vPvM
properties
2022 2032 2042
Number of mixtures based on 11 mixtures per substance
ED 100 2,300 3,200
PBT/vPvB 200 2,400 3,400
PMT/vPvM 100 700 1,200
Total 400 5,300 7,800
Number of mixtures based on 25 mixtures per substance
ED 300 5,100 7,300
PBT/vPvB 400 5,300 7,700
PMT/vPvM 200 1,700 2,700
Total 900 12,200 17,700
More accurately, the totals provided in the table relate to the number of classifications for
mixtures rather than the number of mixtures. This is because some mixtures may meet the
classification criteria for more than one of the hazards.
The table below the estimates of the numbers of substances and mixtures with ED, PBT/vPvB,
PMT/vPvM properties that would be identified and classified under the baseline.
Table 12: Estimated number of substances and mixtures with ED, PBT/vPvB, PMT/vPvM properties that
would be identified and classified under the baseline
2022 2032 2042
Number of substances*
ED 13 210 290
PBT/vPvB 15 210 310
PMT/vPvM 7 70 110
Total 35 490 710
Number of mixtures**
ED 100 – 300 2,300 – 5,100 3,200 – 7,300
PBT/vPvB 200 – 400 2,400 – 5,300 3,400 – 7,700
PMT/vPvM 100 – 200 700 – 1,700 1,200 – 2,700
Total 400 – 900 5,300 – 12,200 7,800 – 17,700
Notes: *rounded to the nearest tens; **rounded to the nearest hundreds
59
The methodology and the results are detailed in Annex 1.
158
1.1.4 Toxicity reference values and harmonised classification and labelling
Already some initiatives or measures may be envisaged as developing harmonised toxicity
reference values. For example, the restriction of the aprotic solvent N,N-dimethylformamide60
involved the derivation of a ‘harmonised DNEL’ for workers (inhalation and dermal) by RAC.
However, harmonisation in this context only relates to the REACH Regulation and other
reference values remain in place, such as the IOELV established by Commission Directive
2009/161/EU of 17 December 2009 (15 mg/m3
as opposed to the ‘harmonised DNEL’ of 6
mg/m3
) that is also legally binding limit value established under OSH legislation in many EU
MS. For companies, the different reference or limit values are confusing and the ‘harmonised
DNEL’ does not resolve the differences between REACH-DNELs and OELs.
The differences between legislations are also evident in other examples. In the case of nonyl-
and octylphenols, EQS were derived under the Water Framework Directive. These may be
considered ‘harmonised reference values’. However, based on the RAC statement related to
the corresponding nonylphenol and octylphenol ethoxylates (ECHA, 2017), it appears
questionable that these EQS may be accepted as a threshold in applications for authorisation.
The same is true is even true within a single regulatory area. For example, the DNEL derived
by RAC for dibutyl phthalate (DBP) in 2013 may be considered a ‘harmonised DNEL’. With
the addition of DBP to REACH Annex XIV for endocrine disrupting properties (human health),
the validity of this reference value is unclear and RAC was not in a position to derive a DNEL
for these effects (ECHA, 2021). Again, diverging OELs are legally in place in several EU MS.
As noted in Annex 4 to this report, reference values established by regulatory agencies are not
necessarily lower than those derived e.g. by registrants under REACH. For example, different
studies were often available to REACH registrants for deriving PNECs compared to the ones
available to the competent authority for the same substance under the BPR. In some cases,
REACH registrants have derived lower PNECs than authorities under the BPR and it may not
be the most meaningful approach to establish the latter as ‘harmonised PNECs’.
It is assumed that the Commission would establish the repository of toxicity reference values
as for its commitment as part of the OSOA approach in the CSS, with the aim of promoting the
reuse of the values among EU risk assessors and managers. It is also assumed that EU agencies
would establish a central coordination mechanism, which would ensure better distribution and
coordination of tasks and access to all data by all agencies, as advocated by ECHA and EFSA
in their joint position paper.
In the period 2016-2020, there has been a steady increase of CLH for CMR substances (71 in
total), leading to the adoption of further RMMs to minimise workers’ exposure (ECHA,
2021c). The IRS has accelerated the screening of registered substances and the identification
of those requiring the generation of further data or risk management. Without intervention in
the coming years, the performance of the IRS and the rhythm of CLH adoption is assumed to
stay constant, as ECHA and RAC work at full capacity and MSCAs’ resources remain limited.
Also, the workload is assumed to remain uneven, with just a few MSCAs carrying most of the
burden.
60
https://echa.europa.eu/de/registry-of-restriction-intentions/-/dislist/details/0b0236e18213ec9e
159
As of 2022, 4,335 entries61
have harmonised classifications. Harmonised classifications and
labelling of hazardous substances are introduced and updated through the Adaptations to
Technical Progress (ATPs), which are issued yearly by the European Commission. Table 12
accounts substances for which the CLH has been revised by subsequent ATPs in the ATP
introducing the CLH for the first time.
Table 13: Number of substances with CLH (2008-2022)
ATP Entry into force No. of substances
CLP00 2008 3,368*
ATP01 2010 758**
ATP03 2012 11
ATP05 2012 22
ATP06 2014 14
ATP07 2016 19
ATP09 2018 26
ATP10 2018 24
ATP13 2020 16
ATP14 2021 17
ATP15 2022 37
Source: Analysis of all CLH from: https://echa.europa.eu/information-on-chemicals/annex-vi-to-clp
Notes: *Harmonised classifications implemented under Directive 67/548/EEC; ** ATP01 brought the
entries from the 30th ATP & 31st ATP of Directive 67/548/EEC into Annex VI of CLP
RAC has adopted between 50-60 opinions on CLH since 2017 (previously the average was 35
per year). These cover both CLH for new substances and revisions of existing CLH. In the last
10 years (2012-2022), 209 new substances have received CLH (median of 20.5 per year). Sixty
is considered as the maximum number of CLH dossiers that RAC and the ECHA team
supporting the CLH procedure can process with the current capacity.62
Following the adoption
of the opinion on the CLH of a substance by the RAC, the European Commission takes a
decision and publishes the updated list in an ATP. Table 13 presents the estimate of the number
of substances with CLH that could be expected in 2032 and 2042, calculated as the linear
forecast of the number of substances with CLH based on the values from ATP03 to ATP17
(2012-2022).63
Table 14: Estimates of the number of CLH substances in 2032 and 2042
2022 2032 2042
Linear forecast 4,385 4,450* 4,600*
Notes: *rounded to the nearest 50s.
1.1.5 Self-classification and the CLI
As of 30th
November 2021, 751,436 notifications have been submitted to the CLI on 205,903
substances, the majority coming from C&L notifications (656,741) and the remainder coming
from REACH Registrations (94,695). Most substances (89%) notified to the CLI originate
61
Some of the entries of Annex VI are group of substances (e.g. the metal compounds), so the number of
substances is higher.
62
ECHA and RAC estimates.
63
CLP00 and ATP01 introduced the CLHs that were adopted according to the previous legislation. Not all ATPs
introduce or revise CLHs.
160
exclusively from CLP notifications, with 11% originating from REACH registrations.
Notification submitters (excluding group members) amount to 22,745 legal entities, of which
14,888 are from REACH Registrations and 12,244 are from CLP notifications. Around 11,055
actual notification submitters are SMEs (48.6% of the total).
A single C&L notification, described as a granular C&L notification, contains a combination
of the following:
Substance;
Substance variant (e.g. physical state / form; chemical hydration; composition with an
impurity / additive etc);
Classification;
Labelling;
Legal entity.
C&L notifications can be submitted by one legal entity on behalf of a group of manufacturers
and importers. For example, the notification submitted on behalf of 50 group members would
resolve into 50 granular C&L notifications, and if the group notification contained two
substance variants, it would resolve into 100 granular notifications. When the number of
granular C&L notifications is taken into account, over 10 million unique notifications have
been submitted to the CLI, which come mainly from expanding the group notifications into
their constituent C&L notifications from the different group members. Data provided by ECHA
shows that on average a group notification contains 44 group members.
The large number of granular C&L notifications that come from group notifications
demonstrates that a significant amount of collaboration between duty-holders is already taking
place to agree on a single classification, which is illustrated in the graphics below. Figure 55
shows the level of agreement for different classifications and labelling combination for
substances in the CLI that have 5 or fewer distinct classifications and labelling combinations.
161
Figure 55: Level of consensus based on individual and lead submissions - Source: ECHA data
Figure 56 factors in the agreement within group notifications is taken into account there is a
much higher level of consensus. It also just shows divergence caused by differences in
classification only, rather than divergence caused by different combinations of classification
and labelling, as substances with the same classification can have two distinct labelling blocks.
Figure 56: Level of consensus factoring in M/I groups - Source: ECHA data
162
However, the level of divergence in Figure 56 is not currently displayed in the existing data
structure of the CLI. The summaries of notified classification and labelling entries are ordered
by number of notifiers, but this only counts M/I groups as one notifier.
78% of substances and 31% of notifications are aligned with a single classification, although
divergence amongst the remaining 22% of substances and 69% of notifications can be due to
legitimate reasons, such as differences in physical form, presence of impurities etc. ECHA also
reports that there is significant agreement for the majority classification (classification most
commonly notified) provided for around a quarter of substances with more than one
classification. This means that for these substances there is a clear preference for one
classification over others. When looking at the level of alignment in granular C&L
notifications, which considers agreement within M/I groups, 77% of the 10 million granular
C&L notifications agree on a classification.
The data shows that classification divergence affects around 22% of notified substances. Sixty-
nine percent (69%) of notifications diverge, but this figure is reduced to 23% once the
agreement within group notifications is taken into account, although this is not visible in the
CLI public portal.
A redesign of the CLI was initiated in 2019 with the aim to improve how data in the CLI is
displayed, structured and made available, in order to bring additional value and improve its
ease of use. While this initiative will not directly address the drivers of diverging classifications
in the CLI, it aims to provide transparency on the reasons for divergence and aims to make
consensus classifications prominent. The redesign is also expected to display agreement within
group notifications. When considering the outcome of the changes in the redesign, if the
changes are made as described, it is expected for the additional information and the prioritising
of consensus classifications to reduce the impacts of the problem. These changes will not
address the source of the divergence. However, the changes, if implemented as described, could
help users prioritise the information in the CLI and subsequently find the most relevant data
reducing the impact of the incorrect classifications. The outcome of the redesign cannot be
fully assessed currently, based on CARACAL discussions, because the redesigned Inventory
is expected to be launched in 2023.
1.1.6 Labelling
This subsection presents the expected evolution of the baseline up to 2042 for each of the four
categories of products that are affected by the problems investigated, namely:
Substances/mixtures supplied in very small packaging (< 10ml);
Substances/mixtures supplied in bulk;
Substances/mixtures supplied via re-fill; and
Substances/mixtures supplied with very small font size and fold out labels.
Substance/Mixtures Supplied in Very Small Packaging (< 10ml)
How would the problem evolve?
There are two drivers contributing to the problem of hazardous substances/mixtures in very
small packaging being unlabelled or incorrectly labelled when placed on the market. The first
163
of these is the impracticality of labelling chemical products in small containers due to the lack
of economically feasible exemptions under the CLP Regulation for the labelling of substances
and mixtures supplied in small packaging and the complexity they introduce for suppliers of
these chemicals. The labelling requirements outlined in the CLP Regulation for bulk and refill
chemicals are expected to remain the same in the baseline scenario, and as there is no financial
incentive for suppliers to change their behaviour, and given that no change in the level of
enforcement surrounding labelling obligations is also expected, the level of non-compliance is
expected to remain the same.
The second driver is the existence of regulatory overlaps in labelling provisions of EU
chemicals legislation, such as those existing between the CLP Regulation and the Detergents
Regulation. The labelling requirements outlined in the CLP Regulation are expected to remain
the same in the baseline scenario. However, in light of the ongoing Impact Assessment into the
revision of the Detergents Regulation, there is a possibility that changes may be made to
labelling requirements applicable to detergents. Ensuring coherence with the CLP Regulation
is one of the aims of the Detergents Regulation Impact Assessment, but as of yet there is no
final decision as to how the interaction between the two on labelling will be addressed. In the
Draft Final Report to the Impact Assessment Study on the simplification of the labelling
requirements for chemicals and the use of e-labelling (VVA et al 2022), four policy options are
being assessed to allow for alignment of CLP and the Detergents Regulation regarding physical
labelling.
One of the policy options is to align the two regulations to address inconsistencies, overlaps
and duplications in labelling requirements. No intervention would occur in the CLP Regulation
but in the Detergents Regulation: ingredients would only be labelled once, either following
CLP or Detergents Regulation rules, which ever is stricter; or removal of all overlapping
provisions. Therefore, it is possible that compliance with labelling provisions for hazardous
substances/mixtures in very small packaging could become easier for detergent products.
However, detergents were not one of the product categories identified as being supplied in very
small packaging. It should also be noted that compliance is an issue with packaging of less than
125ml and consultation with industry as part of this study revealed that labelling is difficult to
fit on packages of up to 200ml in size. In summary, no significant impact on the size of the
problem is expected from the removal of regulatory overlaps in labelling provisions in the
baseline scenario.
The sales of products supplied in packaging smaller than 10ml that are included in our analysis
are expected to slightly increase to 2042, thus maintaining the scale of the problem. This
projection is based on data obtained from Prodcom on annual production quantity dating back
to 2008 and uses the typical mass per product shown in Figure 5. The compound annual growth
rate (CAGR) between 2008 and 2019 was assumed to continue to 2042 for each of the product
categories, resulting in an annual growth rate of 1.1% for pens and writing instruments, -5.4%
for lighters, 1.2% for essential oils, -3.1% for inks, 4.0% for superglues, and -6.0% for
ammunitions. These trends seem to reflect a transition to digital versus printed documents in
certain contexts and the decreasing smoking rates. Additionally, an incompliance rate of 50%
with labelling requirements has been assumed based on enforcement data from ECHA.
Evidence on poisoning from chemicals in very small packaging is not reported by poison
centres, but consultation with the Croatian poison centre provided a datapoint for this in 2021
that has enabled the assumption that each incompliant product sold leads to a rate of 49
poisonings per million products sold. This rate, in the absence of further evidence of the
relationship between product labelling and poisoning incidence, will be treated as a permanent
164
relationship that will define the baseline, with the given baseline compliance level, and the
policy scenario, with its own compliance level.
The baseline projection of sales of products that include substances and mixtures in very small
packaging (< 10 ml) is shown in Figure 57 below, along with the resulting incidence rate of
poisonings involving products in very small packaging in the EU-27.
165
Figure 57: Past series and future projection of the sales of products containing substances/mixtures supplied
in very small packaging (< 10ml) by product category and overall, and baseline projection of poisoning cases
from products in very small packaging (right axis), 2008-2042.
Substances/Mixtures Supplied in Bulk (i.e. fuels)
How would the problem evolve?
The problem of fuels supplied at fuel stations being unlabelled is caused by unclear labelling
requirements under the CLP Regulation for substances supplied in bulk. The lack of specific
provisions (i.e. specific rules or exemptions) in the CLP Regulation for bulk substances leads
to misinterpretation of the requirements which will not change unless action is taken to amend
the legal text of the CLP Regulation, or ECHA guidance on labelling and packaging is updated
to clarify labelling rules for how fuels should be labelled under the CLP Regulation. However,
it should be noted that the update of guidance may have limited impact on the labelling of bulk
chemicals without an explicit mention in the legal text, as it may be viewed as voluntary and
would be difficult to enforce. The current level of provision of CLP labelling of fuels at fuel
stations is not expected to change without regulatory pressure to do so. This is because
provision of labelling represents an addition business cost, and so there is no financial incentive
to provide labelling information. Therefore, without any change to the legal text of the CLP
Regulation to provide clarity on how fuels should be labelled, no change to the scale of the
problem is expected.
While no change in the scale of the problem is expected, the amount of unlabelled fuel placed
on the market is expected to decrease, which is expected to have a subsequent impact on the
number of poisoning incidents involving fuels.The baseline projection for how the size of the
market for fuels used for road and maritime transport will develop up to 2042 will be
determined by environmental objectives and fuel regulations in the road transport sector.
Building from the historic series of final consumption of fuels in road transport64
, the latest
64
Eurostat (2021). Supply, transformation and consumption of oil and petroleum products [nrg_cb_oil]. Available
at: https://appsso.eurostat.ec.europa.eu/nui/show.do?dataset=nrg_cb_oil
0
2
4
6
8
10
12
0,0
0,5
1,0
1,5
2,0
2,5
3,0
3,5
4,0
4,5
Thousand
incidents
Sales
(Million
tonnes)
Ammunitions Pens and writing instruments
Essential oils Lighters
Inks Superglues
Total <10 ml Baseline poisoning cases EU-27
166
projections of oil demand in the EU from the International Energy Agency (IEA, 2021)65
were
used as a reference for the projection of the baseline scenario of substances and mixtures
supplied in bulk. Other candidates considered for the projection of the historic series into the
future were: (a) IEA’s projections of oil demand for passenger cars in advanced economies,
discarded on the grounds that past 2030 oil demand for heavy duty transport will be of higher
relevance than for passenger cars and probably will follow a different path from them; (b)
IEA’s projections of energy consumption in road transport in the EU, discarded due to the
expected change in the energy mix composition of road transport over the next 20 years.
On the contrary, oil demand in the EU is expected to closely follow oil demand in road
transport, being the main source of oil consumption in advanced economies. According to
Eurostat66
48% of oil consumption in the EU belongs to road transport alone, followed by
consumption of oil for non-energy use (14%), for air transport (9%) and water transport (9%).
Thus, using current series of final (energy and non-energy) consumption of oil products in road
transport in the EU-27 and building from the projected scenario for oil demand in the EU
defined by the IEA in its Announced Pledges Scenario, the resulting growth rates between 2020
and 2042 were used to project a baseline for substances and mixtures supplied in bulk. The
projection for the overall EU-27 is shown in the figure below. This projection highlights that
without any regulatory intervention, the amount of unlabelled fuel being placed on the market
is expected to decrease, such that in 2042 less than half the amount of unlabelled fuel will be
placed on the market than 2019 levels.
Figure 58 below shows the past series and future projection of consumption quantity of oil
products in the road transport sector (i.e., substances/mixtures supplied in bulk) and estimated
number of related poisoning incidents in the EU-27 according to the assumed incidence rate
calculated.
Figure 58: Past series and future projection of consumption quantity of oil products in the road transport
sector (i.e., substances/mixtures supplied in bulk) and estimated number of related poisoning incidents in the
EU-27 (right axis), 2008-2042.
65
International Energy Agency (2021). World Energy Outlook 2021.
66
Eurostat (2021) Oil and petroleum products - a statistical overview https://ec.europa.eu/eurostat/statistics-
explained/index.php?title=Oil_and_petroleum_products_-_a_statistical_overview#Consumption_in_sectors
0,0
0,5
1,0
1,5
2,0
2,5
3,0
3,5
4,0
0
50
100
150
200
250
300
Thousand
incidents
Final
consumption
(Mt)
Final consumption - transport
sector - road
Poisoning incidents, EU-27
167
Another factor contributing to the problem is the emergence and increasing trend of consumers
purchasing chemicals via re-fill. Refill sales of chemicals are valued for their potential to
contribute to sustainability and the circular economy by reducing the amount of packaging
waste generated. This is an area of innovation not foreseen when the CLP Regulation was
adopted in 2008 and which the Regulation has not kept pace with. A recent study by Eunomia
provided a first high-level attempt at assessing market trends of packaging free shops, reporting
a central estimate for the EU total turnover from bulk good sales in 2030 of approximately €1.2
billion, and a ‘best case scenario’ of over €3.5 billion. The authors acknowledged that if radical
shifts in the economy or consumer behaviour are also considered, the accurate projections made
on the future scale of the bulk and refill sale sector could be greater. Based on these findings,
the re-fill sale sector is an area with strong predicted growth over the next 10 years. The number
of re-fill chemicals accompanied without correct labelling and packaging and the level of non-
compliance by economic operators are only likely to increase if no action is taken.
Substances/Mixtures Supplied via Re-fill
How would the problem evolve?
The problem of re-fill chemicals being unlabelled or labelled incorrectly is caused by unclear
labelling requirements under the CLP Regulation for these chemicals. The lack of specific
provisions (i.e. specific rules or exemptions) in the CLP Regulation for re-fill chemicals leads
to misinterpretation of the requirements which will not change unless action is taken to amend
the legal text of the CLP Regulation, or ECHA guidance on labelling and packaging is updated
to clarify labelling rules for how re-fill chemicals should be labelled under the CLP Regulation.
However, it should be noted that the update of guidance may have limited impact on the
labelling of re-fill chemicals without an explicit mention in the legal text, as it may be viewed
as voluntary and would be difficult to enforce. The current level of provision of CLP labelling
of re-fill chemicals is not expected to change without regulatory pressure to do so. This is
because provision of labelling represents an addition business cost, and so there is no financial
incentive to provide labelling information.
The labelling requirements outlined in the CLP Regulation for re-fill chemicals are expected
to remain the same in the baseline scenario. In light of the ongoing Impact Assessment into the
revision of the Detergents Regulation, there is a possibility that changes may be made to the
rules for refill detergents. Previous studies have identified problems with the Detergents
Regulation not keeping pace with technical and/ or other developments, such as the increase in
refill sales of detergents. Ensuring coherence with the CLP Regulation is one of the aims of the
Detergents Regulation Impact Assessment, but as of yet there is no final decision as to how the
interaction between the two on labelling will be addressed. In the Draft Final Report to the
Impact Assessment Study on the simplification of the labelling requirements for chemicals and
the use of e-labelling (VVA et al 2022), four policy options are being assessed to allow for
alignment of CLP and the Detergents Regulation regarding physical and digital labelling. These
include:
1. No change in the current mandatory regulatory framework but the setting of non-
mandatory standard on the voluntary use of electronic labels. This option does not allow
manufacturers to replace (partially or totally) physical labels with electronic labels.
2. Aligning the two regulations to address inconsistencies, overlaps and duplications. No
intervention would occur in the CLP Regulation but in the Detergents Regulation:
168
ingredients would only be labelled once, either following CLP or Detergents Regulation
rules, which ever is stricter; or removal of all overlapping provisions.
3. Revision of the labelling rules to introduce digital labelling, whereby manufacturers
could use electronic labels, on a voluntary basis, to provide specific pieces of
information as an alternative to having this information on physical labels. This option
foresees the regulatory interventions discussed under Policy Option 2 to streamline the
regulatory framework.
4. Revision of the labelling rules in the regulations to introduce digital labelling in order
to further simplify physical label, and move the majority of information on the e-label.
5. Revision of the labelling rules in the regulations to introduce digital labelling which
provides all information in the form of an e-label, for specific products. Under the CLP
Regulation it is envisaged that this would refer to re-fill chemicals (fuels to be filled in
containers (not tanks), paints etc.); writing instruments and under the Detergents
Regulation, refill detergents.
Therefore, without any change to the legal text of the CLP Regulation to provide clarity on
how re-fill chemicals should be labelled, no change to the scale of the problem is expected
except for that caused by market forces and consumer behaviour.
The volume of re-fill chemicals that are placed is expected to increase as there is a growing
trend of consumers purchasing chemicals via re-fill. Refill sales of chemicals are valued for
their potential to contribute to sustainability and the circular economy by reducing the amount
of packaging waste generated. This is an area of innovation not foreseen when the CLP
Regulation was adopted in 2008 and which the Regulation has not kept pace with. A recent
study by Eunomia provided a first high-level attempt at assessing market trends of packaging
free shops, reporting a central estimate for the EU total turnover from bulk good sales in 2030
of approximately €1.2 billion, and a ‘best case scenario’ of over €3.5 billion. The authors
acknowledged that if radical shifts in the economy or consumer behaviour are also considered,
the accurate projections made on the future scale of the bulk and refill sale sector could be
greater. Based on these findings, the re-fill sale sector is an area with strong predicted growth
over the next 10 years. The number of re-fill chemicals accompanied without correct labelling
and packaging and the level of non-compliance by economic operators are only likely to
increase if no action is taken.
Looking specifically at re-fill detergents, discussions with industry stakeholders provided
insights and access to the growth expectations for the market of re-fill detergents for the next
6 years in a subset of EU-27 countries. Those were extrapolated to the whole EU-27 by criteria
of proximity and current observed prevalence of re-fill sales of detergents, also provided by
the detergents industry. For years 2027-2042, the compound annual growth rate expected
between 2020 and 2026 was used to project future growth. The projected growth is positive
and around 2% per year, leading to a steady and moderately growing sector.
169
Figure 59: Average growth rates for sales of re-fill detergents as reported by the industry’s projected sales in
five EU-27 Member States for 2020-2026.
Additionally, an average size per refill was estimated to be 2.9 kg, taking into account the most
common bottle sizes for detergents. The series of refills in overall EU-27 is shown in the figure
below. This projection highlights that without any regulatory intervention, the scale of the
problem of unlabelled detergent being placed on the market will increase, such that in 2042
approximately an additional 30 million refills of detergent will be placed on the market that
may be incorrectly labelled or not labelled at all, when compared to 2019 figures (a 50% overall
increase). The resulting number of poisoning incidents involving re-fill detergents is also
displayed based on the incidence rate calculated.
Figure 60: Projection of production quantity of substances/mixtures supplied via re-fill, 2019-2042
Multilingual labels and font size
How would the problem evolve?
0
1
2
3
4
5
6
7
8
Growth
2019-2020
Growth
2020-2021
Growth
2021-2022
Growth
2022-2023
Growth
2023-2024
Growth
2024-2025
Growth
2025-2026
%
gowth
rate
Average growth rates for sales of re-fill
detergents in the EU-27, 2020-2026
0
100
200
300
400
500
600
700
0
10
20
30
40
50
60
70
80
90
100
Number
of
incidents
Estimated
consumption
of
refills
(ktonnes)
Projected sales of re-fill detergents in the EU-27, 2019-2040
Packages sold Incidents
170
There are two drivers contributing to the problem of multilingual labels having poor
readability. The first is the restricted use of multi-lingual fold-out labels. The labelling rules
outlined in the CLP Regulation for multi-lingual fold-out labels are expected to remain the
same in the baseline scenario. Given that there is no financial incentive for limiting the number
of languages on a label and producing a separate label for each destination country, the
readability issues regarding multilingual labels are expected to remain.
The second driver is the existence of regulatory overlaps in labelling provisions of EU
chemicals legislation, such as those existing between the CLP Regulation and the Detergents
Regulation. The labelling requirements outlined in the CLP Regulation are expected to remain
the same in the baseline scenario. However, in light of the ongoing Impact Assessment into the
revision of the Detergents Regulation, there is a possibility that changes may be made to
labelling requirements applicable to detergents. Ensuring coherence with the CLP Regulation
is one of the aims of the Detergents Regulation Impact Assessment, but as of yet there is no
final decision as to how the interaction between the two on labelling will be addressed. In the
Draft Final Report to the Impact Assessment Study on the simplification of the labelling
requirements for chemicals and the use of e-labelling (VVA et al 2022), four policy options are
being assessed to allow for alignment of CLP and the Detergents Regulation regarding physical
labelling.
One of the policy options is to align the two regulations to address inconsistencies, overlaps
and duplications in labelling requirements. No intervention would occur in the CLP Regulation
but in the Detergents Regulation: ingredients would only be labelled once, either following
CLP or Detergents Regulation rules, whichever is stricter; or removal of all overlapping
provisions. With a reduction in the amount of information legally required, the readability of
multilingual labels on detergents could improve under the baseline scenario.
Data from Cefic (2021)67
presented in Table 14 shows the trend in sales between Member
States in the EU27 (intra-EU27 sales) has increased steadily from 2009. This suggests that the
number of products sold between Member States is also increasing and highlights the growing
international market for chemical products. Therefore, the sale of chemicals products in
multiple Member State markets is expected to grow, along with the number of multilingual
labels with poor readability and non-compliant with official language requirements.
67
CEFIC, Facts and Figures of the European Chemical Industry, 2022.
171
Table 15: Trends in chemical sales
Year EU27 Total Sales EU27 Home
Sales
Intra-EU27 Sales EU27 Foreign
Sales
2009 100% 26.2% 44.5% 29.2%
2010 100% 26.5% 44.5% 29.1%
2011 100% 26.1% 45.4% 28.5%
2012 100% 25.6% 44.7% 29.7%
2013 100% 24.8% 45.7% 29.5%
2014 100% 22.3% 47.7% 30.0%
2015 100% 19.8% 48.9% 31.4%
2016 100% 16.5% 50.6% 32.9%
2017 100% 19.4% 49.2% 31.4%
2018 100% 16.0% 52.3% 31.7%
2019 100% 15.0% 52.3% 32.7%
Source: Cefic Facts and Figures 2021
Area 5: CLP scope exemptions
Table 15 shows the main economic aggregates for the sectors currently exempted from CLP
and the forecast for 2032 and 2042.
172
Table 16: Main economic aggregates (2018 data) for the sectors currently exempted from CLP
2018 2020 2032 2042
No. of enterprises
C10 Manufacture of food products 260,257 255,933 251,211 247,276
C10.9 Manufacture of prepared animal feeds 5,196 5,133 5,572 5,938
C20.42 Manufacture of perfumes and toilet
preparations
5,888 6,192 9,206 11,717
C21 Manufacture of basic pharmaceutical
products and pharmaceutical preparations**
4,263 4,455 5,609 6,570
Turnover – million euro
C10 Manufacture of food products 940,137 966,390 1,94,385 1,384,381
C10.9 Manufacture of prepared animal feeds 73,511.7 75,015 84,354 92,137
C20.42 Manufacture of perfumes and toilet
preparations
48,093.9 52,821 79,041 102,878
C21 Manufacture of basic pharmaceutical
products and pharmaceutical preparations**
277,391 299,581 432,721 543,670
Value added at factor cost – million euro
C10 Manufacture of food products 182,684.0 188,339 249,166 299,855
C10.9 Manufacture of prepared animal feeds 9,300.5 9,776 12,953 15,601
C20.42 Manufacture of perfumes and toilet
preparations
14,000 15,117 25,834 34,764
C21 Manufacture of basic pharmaceutical
products and pharmaceutical preparations**
112,511.1 115,415 180,350 234,462
Persons employed – number
C10 Manufacture of food products 4,100,000 4,051,567 4,556,534 4,977,340
C10.9 Manufacture of prepared animal feeds 123,395 125,287 148,180 167,258
C20.42 Manufacture of perfumes and toilet
preparations
173,891 179,791 274,672 352,987
C21 Manufacture of basic pharmaceutical
products and pharmaceutical preparations**
605,315 611,363 788,223 935,606
Notes: Eurostat database – Structural Business Statistics
*2017 data; **include manufacture of in vitro diagnostics (NACE 21.20); ***2016 data
Without policy action, the environmental hazards of human medicinal products (HMPs) and
veterinary medicinal products (VMPs) will keep being identified through the environmental
risk assessments required by the relevant legislation. HMPs and VMPs are accompanied by
package leaflets that may also contain important information about the safety of the products,
their disposal or any precautionary measures to be taken, but environmental hazards identified
through risk assessment may not be necessarily displayed.
In 2016, around 3,000 active pharmaceutical substances were authorised on the EU market
(Deloitte et al., 2016). The Union register of medicinal products68
lists around 12,370 items,
between centrally authorised and nationally authorised medicinal products for human and
veterinary use and orphan designations. The EMA recommends for authorisation a median of
39 new active substances for human and veterinary medicinal products per year and 97 new
human and veterinary medicinal products per year.69
Table 16 shows the estimates of the
68
https://ec.europa.eu/health/documents/community-register/html/reg_index_inn.htm
69
Based on the number of HMPs and VMPs (active substances and products) recommended for authorisation by
the EMA between 2015-2020. Source: https://www.ema.europa.eu/en/about-us/annual-reports-work-programmes
173
cumulative number of HMPs and VMPs (active substances and products) recommended for
authorisation by EMA in the period 2015-2020.
Table 17: Estimates of the cumulative number of HMPs and VMPs (active substances and products) on the
EU market
2020 2032 2042
Human and veterinary medicinal products
New medicines* 12,100 13,350 14,300
New active substances* 3,150 3,650 4,050
Notes: *Rounded to the nearest 50
To tackle the presence of pharmaceuticals and their negative effects on the environment, in
2019 the European Commission has adopted the Strategic approach to pharmaceuticals in the
environment, which aims to mitigate the environmental issues caused by human and veterinary
medicines. Table 17 provides examples of measures to ensure protection from the
environmental hazards borne by pharmaceuticals that have been implemented within the
Strategic approach to pharmaceuticals in the environment.
174
Table 18: Overview of measures related to the environmental risk assessment and public awareness of the
environmental hazards of pharmaceuticals, compiled from European Commission, 2020
Measure Status
Action 5.1.1 Promote the development of guidelines for healthcare professionals
on the prudent use of pharmaceuticals posing a risk to or via the environment.
Ongoing
Action 5.1.4 Foster best-practice exchanges between the Member States on how
environmental considerations are taken into account in the advertising and
prescription of medicinal products and the choice of therapy more generally,
where appropriate.
Ongoing
Action 5.3.1a In collaboration with the European Medicines Agency and the
Member States: Seek to improve the level of environmental expertise in the
Committees and networks involved in the environmental risk assessment of
medicinal products.
Ongoing
Action 5.3.1b In collaboration with the European Medicines Agency and the
Member States: Consider developing guidance on the environmental risk
assessment of medicinal products for use in aquaculture including, where
appropriate, recommendations for risk management measures.
Started
Action 5.3.1c In collaboration with the European Medicines Agency and the
Member States: Examine how to improve public access to the main
environmental risk assessment results and relevant toxicological thresholds for
medicinal products while respecting data-protection rules.
Ongoing
Action 5.3.1d In collaboration with the European Medicines Agency and the
Member States: Emphasise to applicants the importance of submitting a
completed assessment by the time of the authorisation for marketing human
medicinal products, so that adequate risk management measures can be
established and published.
Ongoing
Action 5.3.2 Pursuant to the newly adopted Regulation on veterinary medicinal
products, report on the feasibility of setting up an EU-wide review system based
on active pharmaceutical ingredients, or similar, to support the environmental
risk assessment of veterinary medicinal products at the Union level.
Started
Action 5.3.3 Initiate a systematic catching-up procedure for veterinary medicinal
products without an (adequate) environmental risk assessment, as provided for in
the Regulation on veterinary medicinal products, and take stock of the results of
research under the Innovative Medicines Initiative in relation to human medicinal
products.
Ongoing
Action 5.4.1b In collaboration with the Member States and the European
Medicines Agency: Facilitate the exchange of best practices among healthcare
professionals on the environmentally safe disposal of medicinal products and
clinical waste, and the collection of pharmaceutical residues as appropriate.
Ongoing
Action 5.4.2 Assess the implementation of collection schemes for unused
pharmaceuticals and consider how their availability and functioning could be
improved, how to increase public awareness of the importance of using them, and
how extended producer responsibility could play a role in reducing inappropriate
disposal.
Good
progress
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Currently, ‘the environmental concerns that substances used in cosmetic products may raise
are considered through the application of REACH’ (Recital 5 of the CPR). Chemical
substances used as cosmetic ingredients with adverse effects to the environment can be, for
example, subject to authorisations or restrictions. Without policy action, the labelling of the
environmental hazards of cosmetic products is not required and, therefore, the only way for
consumers to check this information is by consulting the list of ingredients and searching for
data online.
The CPR is being reviewed to align the current rules on cosmetics with the objectives of the
CSS and ensure better protection of human health and environment in line with boosting
innovation. Simplification and digitisation of product label information is one of the possible
options to be analysed (European Commission, 2021).70
Searching the ECHA registered substances database for substances with notified uses in
Product Category (PC) 28 ‘Perfumes, fragrances’ and PC39 ‘Cosmetics, personal care
products’ returns 3,248 substances.
Table 19: Registered substances with product categories PC28 ‘Perfumes, fragrances’ and PC39 ‘Cosmetics,
personal care products’ per tonnage band
Tonnage band Number of registered substances
1-10 tonnes per year 895
10-100 tonnes per year 719
100-1,000 tonnes per year 618
1,000-10,000 tonnes per year 499
10,000-100,000 tonnes per year 248
100,000-1,000,000 tonnes per year 106
1,000,000-10,000,000 tonnes per year 56
10,000,000-100,000,000 tonnes per year 16
Cease manufacture 48
No longer valid 25
Tonnage data confidential 9
Intermediate use only 9
Total 3,248
Source: registered substances database
https://echa.europa.eu/information-on-chemicals/registered-substances
According to these data, a quantity between 229,648,885 and 2,296,488,850 tonnes71
of
substances used as ‘perfumes, fragrances’ and ‘cosmetics, personal care products’ is
manufactured or imported on the EU market every year. Table 19 shows the classification of
registered substances with notified uses in product categories PC28 ‘Perfumes, fragrances’ and
PC39 ‘Cosmetics, personal care products’.
70
European Commission, EU Chemicals Strategy for Sustainability - Revision of the Cosmetic Products
Regulation, 2021.
71
The minimum and maximum quantities are obtained by multiplying the number of substances for the lower-
bound and upper-bound of the tonnage band. The average is 1,263,000,000 tpa.
176
Table 20: Classification of registered substances with product categories PC28 ‘Perfumes, fragrances’ and
PC39 ‘Cosmetics, personal care products’
Registered substances with product categories PC28 ‘Perfumes,
fragrances’ and PC39 ‘Cosmetics, personal care products
Number
Total 3,248
With CLP Notification C&L data for environmental hazards 1,553 (47.8%)
With REACH Registration C&L data for environmental hazards 1,132 (34.9%)
With CLH for any hazard 274 (8.4%)
With CLH for environmental hazards 167 (5.1%)
With recognised properties of concern* 83 (2.6%)
Included in the Candidate list (Art. 57 intrinsic properties) 14 (0.4%)
Source: registered substances database
https://echa.europa.eu/information-on-chemicals/registered-substances
Notes: *Recognised as: carcinogenic or mutagenic or toxic to reproduction or respiratory sensitiser or skin
sensitiser or persistent, bioaccumulative and toxic or endocrine disrupting or persistent organic pollutants;
**ECHA restriction list (February 2022) contains 71 entries including 2,169 substances.
Some cosmetic products, such as personal care products containing plastic microbeads,
siloxanes, synthetic fragrances, UV filters or triclosan, have negative effects on the
environment due to their hazardous properties and their releases to the environment during use.
Around 8% of the substances (274 out of 3,248) have CLH for different hazard classes. Fifty-
six (56) substances have CLH for acute aquatic toxicity and 111 for chronic aquatic toxicity.
Some of the environmental hazards of cosmetics ingredients have been and are being addressed
through restrictions under the REACH Regulation, such as the restriction of cyclopentasiloxane
(D5) and cyclotetrasiloxane (D4), microplastics, etc. (see the supporting study in Annex 4).
It should be noted that there is a growing interest in the environmental performance of
products in general and in providing consumers with transparent information in
particular. Actions such as the Sustainable Products Initiative, Ecolabel and the
EcoBeautyScore Consortium72
can influence communication of the environmental hazards of
cosmetic products.
The Sustainable Product Initiative (SPI) was announced by the European Commission in 2020
in the Circular Economy Action Plan. It revises the Ecodesign Directive and covers the
environmental performance of goods and services. The aim is to ensure high environmental
performance for all products (including cosmetic products) on the EU market. For this purpose,
specific environmental requirements and sustainability principles are being developed,
addressing the lack of reliable sustainability information about the products. By providing
suitable solutions, such as digital product passports, it will improve communication of the
environmental performance of the products to consumers and enable them to make informed
decisions when buying a product. The revision is planned to be completed in the first quarter
of 2022 (European Commission, 2020).73
In 2021, the European Commission revised the EU Ecolabel criteria for cosmetics and extended
them to substances or mixtures that fall under the scope of the CPR and “intended to be placed
72
https://www.cosmeticsdesign-europe.com/Article/2021/09/20/Henkel-L-Oreal-LVMH-Natura-Co-Unilever-
forming-consortium-for-cosmetics-environmental-impact-system
73
European Commission (2020). Sustainable Products Initiative. Available at:
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12567-Sustainable-products-
initiative_en
177
in contact with the external parts of the human body, or with the teeth and the mucous
membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming
them, changing their appearance, protecting them, keeping them in good condition or
correcting body odours” (EC, 2021g, Article 1). The revised criteria for awarding the EU
Ecolabel now apply both to rinse-off and leave-on cosmetic products. They include:
Toxicity to aquatic organisms: critical dilution volume (CDV) of rinse-off products;
Biodegradability of rinse-off products;
Aquatic toxicity and biodegradability of leave-on products;
Excluded and restricted substances;
Packaging;
Sustainable sourcing of palm oil, palm kernel oil and their derivatives;
Fitness for use;
Information on EU Ecolabel.
The European Commission has observed a growth in interest in obtaining the EU Ecolabel,
mirroring the increasing interest on green products by consumers. According to the European
Commission, 2,057 licences have been awarded for 83,590 products in the EU. Twenty-one
percent (21%) (118 out of 2,057) were awarded to rinse-off cosmetic products, covering 2,575
products (around 3% of the total number of awarded products) (EC, 2021g).
Figure 61: Licences and products
Finally, in 2021, Henkel, L’Oréal, LVMH, Natura &Co, and Unilever launched a global
consortium, open to all cosmetics company, to develop an environmental impact assessment
and scoring system for cosmetics products. This initiative aims at providing consumers with
comparable and transparent information about the environmental impact of cosmetic products.
The assessment and scoring systems will be based on a common product lifecycle assessment
methodology for measuring the environmental impacts of a product, common database of
environmental impacts and tools to calculate them in line with a harmonized system for scoring
the environmental performance (Unilever, 2021).74
The initiative has just been launched and it
is therefore too early to judge its scope and potential results.
74
Unilever, New cosmetics consortium to co-design environmental impact assessment and scoring system, 2021.
178
1.1.7 Online sales of chemicals
The evolution of the problem of non-compliance of chemicals sold online with the CLP
Regulation over time will be shaped by the development in e-commerce and regulatory and
non-regulatory initiatives that have been already undertaken by the Commission.
Data underpinning the trend of increased online sales
Concerning the uptake of e-commerce services by consumers, an increased number of
consumer purchases are made online, therefore, chances rise that consumers will be affected
by non-compliant chemicals sold online. Data from the EU annual survey on the use of
Information and Communication Technologies (ICT) in households and by individuals show
that in 2020 and 202175
around 8% of all individuals in the EU27 who have used the internet
in the three months prior to the survey bought cleaning products or personal hygiene products
online76
.
Online shopping behaviour of consumers was also explored by business entities. For instance,
in 2018, a research commissioned by Dynamic Parcel Distribution (DPD) to Kantar covered a
survey of 24,328 respondents from 21 European countries, while the survey performed by Ipsos
for PayPal covered 34,000 customers in 31 countries. The findings of these researches are in
line with the data by Eurostat and also provide additional insight into consumer behaviour:
According to PayPal research, 43% of shoppers in Western Europe and 44% in Eastern
Europe77
shop online domestically, while 9% and 10% are, respectively, engaged only in cross-
border shopping. Over 50% of Western and Eastern Europeans prefer large global stores
(e.g., Amazon or eBay) when purchasing from another country (PayPal & Ipsos, 2018).
According to Dynamic Parcel Distribution research, 19% of online shoppers in Europe
purchased goods from foreign websites. However, in some countries the number of online
shoppers buying from foreign countries is much higher, e.g., in Croatia – 29.6%, Ireland –
28.6%, Latvia – 27.9%, Portugal – 27.6%, and Slovenia – 27.5%. 13% of online shoppers in
Europe in 2018 purchased online at least once per week (DPD Group & Kantar, 2018).
Also the number of EU companies using e-commerce increases constantly, and web sales
through websites, online sales apps, and online marketplaces play an increasingly important
role. According to Eurostat, in the period 2010–2019, the number of enterprises with e-sales
increased from 15% in 2010 to 21% in 2019. The turnover of enterprises generated from e-
sales grew from 13% in 2010 to 20% in 2019. Fifteen percent (15%) of EU enterprises
conducted e-sales using only websites or apps, while 3% used only electronic data interchange
(EDI) for sales and another 3% used both.
Chemicals industry is increasingly engaged in trading via online marketplaces. The
evolution of chemical online marketplaces could be tracked back to 1996 with the
75
These are the only years for which data are provided.
76
Eurostat database: Internet purchases – goods or services (2020 onwards)
[ISOC_EC_IBGS__custom_2139201]. This is the only product category reported in the survey which is subject
to CLP requirements. The statistics shows large differences between countries, with 24% of Dutch individuals in
2021 having purchased cleaning products or personal hygiene products online, against 1% of all individuals in
Bulgaria.
77
Russian Federation was also included in the group of Eastern European countries.
179
establishment of such platforms as EC Plaza in 1996. According to Accenture, early chemical
online marketplaces were mainly business-to-business services, while much later generalist
online marketplaces, such as Alibaba.com started to offer chemical products to consumers
(Elser & Radel, 202078
). In its annual chemical marketplaces report, Chembid listed 61 online
platforms. According to Chembid79
, chemical online marketplaces usually offer up to 10,000
products from up to 25,000 suppliers (Chembid, 202080
).
The following trends could be retrieved from a study on cross-border online sales (Cross-
Border Commerce Europe, 2020)81
:
Growing revenues in cross-border online retail sales. The study observed a 14.4% increase in
e-commerce revenues compared to 2018 (excluding travel sector). In 2019 the cross-border
share was 23.55% of total online sales in Europe (EU16).
The market share of EU and non-EU players in online retail is almost equal: 55% is generated
by the EU traders and 45% by non-EU retailers. In 2019, the market share of the EU traders
increased by 3% compared to 2018.
Online marketplaces play a significant role in online sales. In cross-border trade within the EU,
25 online marketplaces had a turnover of €10.5 billion in 2019 or 26.4% of total sales and an
increase of 17% compared to 2018. According to the study, online marketplaces grow faster
than the average market. In online trade by non-EU retailers, 80% of cross-border sales are
generated through online marketplaces, with Amazon as a leader with € 32 billion from sales.
Estimations of incompliant chemicals related to the problems outlined above
Data on the CLP incompliances of online chemicals’ sales in and outside the EU that are
relevant for problem 1 and data on imports that are relevant for problem 2 is not available. The
figures below are established based on estimations which bring some uncertainty on the place
of origin of sellers (it must be assumed that in reality even more chemicals originate from
outside the EU although they are sold by domestic platforms), the overall chemicals’
incompliance rate compared to mere samples, the number of consumers exposed to incompliant
chemicals82
.
With respect to CLP non-compliant items from online sellers within the EU:
In 2021, 251 million consumers in the EU purchased goods online from sellers within the EU.
These consumers purchased 111 million items from categories of goods for which CLP
requirements are relevant for some of the goods.
78
Elser, B. & Radel, T. (2020). Why digital marketplaces deserve a chance in chemicals. In Accenture Chemicals
and Natural Resources Blog. Available at: https://www.accenture.com/us-en/blogs/chemicals-and-natural-
resources-blog/elser-radel-digital-marketplaces-deserve-a-chance-in-chemicals
79
Chembid is an online metasearch engine and intelligence platform for chemical business that compiles a yearly
chemical marketplaces report that reviews and compares emerging online platforms.
80
Chembid (2020). The chemical marketplaces report 2021. Available at:
https://f.hubspotusercontent40.net/hubfs/6037596/chembids%20Chemical%20Marketplaces%20Report%20202
1.pdf
81
The analysis was based on the data from 16 countries from Western Europe and Scandinavia that put limitations
on the findings of this study in terms of generalising its result to the EU.
82
See detailed description of the methodology used in the Appendix.
180
Based on estimations, 16.6 million of the 111 million items purchased by these consumers from
sellers within the EU were not compliant with CLP requirements.
Based on estimations, in 2021, 9.6 million consumers purchased one CLP non-compliant item
from sellers within the EU and a further 3.5 million consumers purchased two CLP non-
compliant products from sellers within the EU – making a total of 16.6 million CLP non-
compliant items purchased from sellers within the EU.
With respect to CLP non-compliant items from sellers outside the EU:
In 2021 there were some 69.5 million consumers in the EU who purchased goods online from
sellers outside the EU. These consumers purchased 32.4 million items from categories of goods
for which CLP requirements are relevant for some of the goods.
Based also on estimations, 7.3 million of the 32.4 million items purchased by these consumers
from sellers outside the EU were not compliant with CLP requirements.
Following the same logic as before, in 2021, 4.2 million consumers purchased one CLP non-
compliant item from sellers outside the EU and a further 1.6 million consumers purchased two
CLP non-compliant products from sellers outside the EU – making a total of 7.3 million CLP
non-compliant items purchased from sellers outside the EU.
The number of non-compliant items and consumers of those items is summarised in the table
below for all three scenarios (lower, central and upper).
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Table 21: Number of non-compliant items and consumers of those items
Non-compliance
issue
Location of
seller
Number of
non-
compliant
items
purchased per
year (million)
Number of consumers
purchasing
one non-
compliant
item per year
(million)
two non-
compliant items
per year
(million)
Lower scenario
REACH
restriction non-
compliant items
within EU 42.5 24.5 9.0
outside EU 17.0 9.8 3.6
CLP non-
compliant items
within EU 11.1 6.4 2.3
outside EU 4.4 2.6 0.9
Central scenario
REACH
restriction non-
compliant items
within EU 70.8 40.9 14.9
outside EU 31.0 17.8 6.6
CLP non-
compliant items
within EU 16.6 9.6 3.5
outside EU 7.3 4.2 1.6
Upper scenario
REACH
restriction non-
compliant items
within EU 110.0 63.6 23.2
outside EU 64.3 36.9 13.7
CLP non-
compliant items
within EU 33.3 19.2 7.0
outside EU 19.5 11.2 4.1
Description of draft and already applicable EU legislation relevant for solving the problems
Taking into account the dynamic baseline, the following EU legislation should be considered:
the draft Digital Services Act83
, the draft General Product Safety Regulation84
, the already
applicable Market Surveillance Regulation85
, the Consumer Rights Directive86
and customs
legislation87
.
83
Proposal for a Regulation of the European Parliament and of the Council on a Single Market For Digital Services
(Digital Services Act) and amending Directive 2000/31/EC, COM(2020) 825 final.
84
Proposal for a Regulation of the European Parliament and of the Council on general product safety, amending
Regulation (EU) No 1025/2012 of the European Parliament and of the Council, and repealing Council Directive
87/357/EEC and Directive 2001/95/EC of the European Parliament and of the Council, COM(2021) 346 final.
85
Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market
surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008
and (EU) No 305/2011, OJ L 169, p. 1.
86
Directive 2011/83/EU on consumer rights, OJ L 304, p.64.
87
Regulation (EU) No 952/2013 laying down the Union Customs Code (“UCC”), OJ L 269 10.10.2013, p. 1;
amendments made in 2019 and 2020 to the UCC Delegated Regulation (EU) 2015/2446 of 28 July 2015
supplementing Regulation (EU) No 952/2013 of the European Parliament and of the Council as regards detailed
rules concerning certain provisions of the Union Customs, OJ L 343 29.12.2015, p. 1; Implementing Regulation
(EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of
Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs
Code, OJ L 343 29.12.2015, p. 558.
182
A description of the interface of those pieces of legislation with the analysed policy options
is provided in Annex 15 on online sales (baseline section).
1.1.8 Poison Centers
The baseline from which policy options are assessed is the currently applicable regulatory
framework, i.e. obligations by downstream users and importers as per Article 45, by
distributers and other supplier types as per Article 4(10)88
, and clarifications of those
obligations enshrined in ECHA guidance. ECHA guidance already address the problem the
best way possible, therefore, improving ECHA guidance was not explored as non-regulatory
policy option (“no-policy-change” scenario). To solve the problem, no not yet adopted
legislation is relevant, so that only the applicable legislation and guidance should be taken into
account for addressing the problem. Based on assumptions, a max. of 50% of distributors who
should have to comply by virtue of Article 4(10) adhere to the rules in reality. This reality
scenario is not going to change drastically within the next 20 years without any legislative
intervention, thus the problem continues existing.
Notifications received by ECHA in 2021
The number of Notifications to Poison Centres (PCNs) received in 2021 was 1,444,290, but
submissions to multiple Member States can be made in a single notification. Expanding the
number of notifications to include all multiple submissions results in almost 7.7 million
notifications. Submission numbers for the next years are expected to be lower given that 2021
was the first applicability date to notify information on consumer mixtures under the new
requirements of Annex VIII on poison centres89
.
Trends in chemicals intra-EU trade
In the years to come, intra-EU chemicals sales (and hence distribution as well) are expected to
grow, which translates into increasing the scale of the problem of having information loss in
certain cases. Figure 62 shows the trend in sales between EU Member States have increased
steadily from 44.5% of all chemical sales in 2009 to 52.3% of all chemical sales in 2019.
88
Article 4(10) of CLP provides for the general obligation to comply with CLP. Based on ECHA guidance, a
distributor placing on the market a hazardous mixture, which would jeopardise an appointed body’s access to
relevant information, would run the risk of breaching Article 4(10) that substances and mixtures can only be
placed on the market if they comply with CLP.
89
Commission Delegated Regulations 2020/1676 and 2020/1677, OJ L 379, p. 1 and 3.
183
Figure 62: Trend in sales between EU Member States
Data from Eurostat79
shows that in 2020 intra-EU sales of chemicals accounted for €496 billion
in 2020 (up from €207 billion in 2002), which made up 17% of all intra-EU sales.
Number of distributors and distributed products and re-branders/re-labellers and relabelled
products
In order to quantitatively assess how many mixtures should be notified to prevent information
loss, estimations were carried out which might have their limitations or bring about some levels
of uncertainty (see Annex 16).
Estimates further described in Annex 16 conclude that intra-EU distributors place between
220,000 – 560,000 products on another Member States’ market and re-branders/re-labellers
between 32,500 – 77,500 on their Member States’ market. This amounts to between 252,500 –
637,500 products distributed that should be notified. In reality a certain percentage of that range
will be notified already due to distributors adhering to Article 4(10) of CLP, hence the number
of not notified mixtures leading to information loss will be lower than the range from 252,500
– 637,500 products.
Cost of non-Europe
It is worth mentioning that the entire poison centres format and notification system was already
significantly simplified without lowering the level of safety by adopting the latest versions of
Annex VIII on poison centres in 202090
via delegated act. Before adopting Annex VIII, a study
by Kirhensteine et al. (2015) estimated that net cost savings across the EU of €550 million per
annum (equivalent to €40,000 per company) could be achieved through harmonisation of the
CLP Regulation (cost of Europe non acting).
90
Commission Delegated Regulations 2020/1676 and 2020/1677, OJ L 379, p. 1 and 3.
184
2 DISCARDED MEASURES
Table 21 in Annex 7 provides the full list of measures that have been considered but discarded and the rationale behind their screening out from
further assessment.
Table 22: Discarded measures on the basis of initial screening
Problem area Discarded measure Justification for discarding
Identification and
classification of
chemical hazards
DM1 Promote the harmonisation of criteria for the new
hazard classes (ED, PBT, vPvB, PMT, vPvM) at the UN
level (GHS) before introducing them in the CLP
Several industries were of the view that new hazard classes should be first
introduced in GHS, and only after in CLP, in order to ensure a level playing field
and global harmonisation of rules. However, the lack of new hazard classes was
long identified by scientists and stakeholders as an area where urgent action is
needed, and it is one of the high priorities identified in the Chemicals Strategy.
The option was discarded on three main grounds: i) GHS is based on a ‘building
block’ system, leaving margins of flexibility to what their parties can require
internally; ii) discussions and agreements at UN level are very lengthy processes,
and former Commission’s and/or EU Member States’ suggestions of new hazard
classes were not successful. EU legislation and standards on chemicals have
traditionally been the driver for higher international standards, including for GHS
and the EU criteria for the new hazard classes would be again the starting basis
for a global discussion; iii) introducing new classes in CLP before GHS could
lead to non-tariff barriers to trade, but, on the basis of modelling from past
studies, the impact on international trade was estimated not be significant and that
other variables – such as energy prices – are much more relevant. Moreover, from
a competitiveness angle, acting at EU level first will strengthen the EU’s role as a
global front-runner in health and environmental standards, driving the EU
industry’s leadership in producing and using sustainable chemicals, levelling the
playing field, and thereby giving the EU industry a competitive advantage
allowing it to increase its global market share for chemicals and safer
alternatives.
DM2 create a repository of toxicity reference values Part of the baseline, this measure will be implementted within the One substance,
one assessment process initiated by the Chemicals Strategy.
DM3 create a central coordination mechanism to harmonise
toxicity reference values across different chemical
regulatory framework
To be assessed by a study focusing on the one substance, one assessment
approach. Such a central coordination mechanism, proposed in the ECHA and
EFSA Joint position paper on one substance - one assessment,[1] would include a
coordinated problem formulation phase (i.e. identifying the correct scientific
question that needs to be answered) which would enhance predictability for
industry. This may include a public EU coordination registry, potentially
developed from ECHA’s PACT (Public Activities Coordination Tool), to
185
increase transparency and predictability on substance-specific activities by
authorities across different chemical regulatory frameworks.
DM4 Risk Assessment Committee opinions include the
derivation of point of departures (NOAEL/NOAEC) when
performing the review of harmonised classification dossiers
for the hazard classes under the scope of the harmonised
classification dossier
It does not appear meaningful to derive a point of departure without a
consideration of the complete toxicological profile of a substance.
Communication of
chemical hazards
DM5 Revoke the exemption for the labelling of the human
health hazards of medicinal products
Effectiveness and proportionality: Legislation contains comprehensive provisions
to assess hazards and risks to human health and to provide relevant information
and instructions to users. Additional labelling for human health hazards according
to CLP would not contribute to an increased level of protection.
DM6 Revoke the exemption for the labelling of the
environmental hazards of medicinal products
Effectiveness and proportionality: Ample evidence for negative environmental
impacts, but legislation contains comprehensive provisions for environmental risk
assessment, risk mitigation and provision of information and instructions to users.
Ongoing initiatives aiming to further mitigate the environmental impact of
medicinal products. Therefore, labelling for environmental hazards according to
CLP is not expected to have a significant added value.
DM7 Revoke the exemption for the labelling of the
environmental hazards of veterinary medicinal products
Effectiveness and proportionality: Ample evidence for negative environmental
impacts, but legislation contains comprehensive provisions for environmental risk
assessment, risk mitigation and provision of information and instructions to users.
Ongoing initiatives aiming to further mitigate the environmental impact of
medicinal products. Therefore, labelling for environmental hazards according to
CLP is not expected to have a significant added value.
DM8 Revoke the exemption for the labelling of the
environmental hazards of medical devices
Relevance and effectiveness: No solid evidence for a negative environmental
impact of products. Relevant legislation addresses environmental effects and the
provision of information to users. Labelling for environmental hazards according
to CLP is not expected to have a significant added value.
DM9 Revoke the exemption for the labelling of the
environmental hazards of cosmetic products
Effectiveness: Solid evidence for negative environmental impacts from certain
ingredients. The relevant legislation does not provide for assessment of or
information on environmental aspects. While environmental risks posed by
cosmetic ingredients can be addressed by the horizontal provisions of REACH,
there is a regulatory gap in relation to information on environmental hazards to
users, which may be closed by removing the exemption in CLP for cosmetic
products. However, the impact of CLP labelling on consumer behaviour (use,
purchasing choices) is uncertain, and a number of relevant initiatives (see Annex
14) are currently under way that may significantly change the availability of
information of environmental impacts, as well as the impact itself, of cosmetic
products. Therefore, it is currently difficult to assess the impact of labelling for
186
environmental hazards according to CLP, and not possible to conclude whether
removing the exemption for cosmetic products in CLP is a suitable option.
DM10 Revoke the exemption for the labelling of the
environmental hazards of food or feeding stuffs
No solid evidence for a negative environmental impact of products. Relevant
legislation addresses environmental effects and the provision of information to
users. Labelling for environmental hazards according to CLP is not expected to
have a significant added value.
DM11 Introduce digital labelling as an alternative to CLP
physical label
Significant costs for businesses (SMEs in particular) to implement the new
measures (one off and maintenance costs) associated with incomplete access to
digital means by EU citizens. This was not widely accepted by stakeholders,
particularly National Authorities as this would further deviate from the UN GHS
significantly.
DM12 Introduce mandatory digital labelling for CLP labels Significant costs for businesses (SMEs in particular) to implement such a
measure. This option cannot exclude that some product users, particularly
consumers, would not be able to access digital product information due to lack of
access to digital tools, lack of digital skills and lack of internet connection.
Implementation of
CLP rules
DM13 Introduce obligation to make online platforms the
responsible actors for compliance in the EU
Not in line with the draft Digital Services Act91
as well as the E-Commerce
Directive92
providing for a conditional liability exemption of online platforms.
DM14: Change the entire system and allow submissions via
the ECHA portal only with information storage in ECHA’s
database and access by all Member States
Very disruptive measure for a system that is only applicable as of 2020; no
support from either Member States or stakeholders; measure would solve the
problem only partially (not for re-branders/-relabellers).
DM15 Amend CLP to make online platforms the
responsible actor in the EU by default
Too disruptive measure for a just recently introduced system, not appreciated by
any Member State nor stakeholder.
DM16 Improving ECHA guidance on notifications to
poison centres
ECHA guidance has been assessed as already addressing the problem, but
improvements could not solve the main issues, as distributors continue placing on
the market hazardous mixtures supplied cross-border and re-branded.
91
Proposal for a Digital Services Act and amending Directive 2000/31/EC, COM(2020) 825 final.
92
Directive 2000/31/EC, OJ L 178/1.
187
Annex 8 – New Hazard Classes
CONTEXT
The CSS calls for the strengthening CLP and, more specifically, states that the Commission
will ‘propose new hazard classes and criteria in CLP to fully address environmental toxicity,
persistency, mobility and bioaccumulation’ and ‘ensure that the CLP is the central piece for
hazard classification and allows the Commission to initiate harmonised classifications’93
. The
CLP revision will be closely followed by the revision of REACH and other chemical legislative
acts (EC, 2020c94
) that will benefit from the CLP revision as classification of substances and
mixtures trigger legislative actions or direct obligation under downstream legislation.
Several Sustainable Development Goals (SDG) are linked to this problem, especially:
 SDG #3 Good health and well-being – Target 3.9 ‘By 2030, substantially reduce the
number of deaths and illnesses from hazardous chemicals and air, water and soil
pollution and contamination’: the inclusion of new hazard classes on EDs will
contribute to this goal by better protecting human health.
 SDG #6 Clean water and sanitation – Target 6.3 ‘By 2030, improve water quality by
reducing pollution, eliminating dumping and minimizing release of hazardous
chemicals and materials, halving the proportion of untreated wastewater and
substantially increasing recycling and safe reuse globally’: all new hazard classes will
also participate to this goal, in particular the new hazard classes on PMT and vPvM.
 SDG #9 Industry, innovation and infrastructure – Target 9.4 ‘By 2030, upgrade
infrastructure and retrofit industries to make them sustainable, with increased resource-
use efficiency and greater adoption of clean and environmentally sound technologies
and industrial processes, with all countries taking action in accordance with their
respective capabilities’: the new hazard classes will help in the identification of
sustainable alternatives.
 SDG #12 Responsible consumption and production – Target 12.4 ‘By 2020, achieve
the environmentally sound management of chemicals and all wastes throughout their
life cycle, in accordance with agreed international frameworks, and significantly reduce
their release to air, water and soil in order to minimize their adverse impacts on human
health and the environment’: the new hazard classes will have downstream
consequences, which will at the end impact the full life cycle of this products.
93
COM(2020) 667.
94
COM(2020) 667.
188
DESCRIPTION OF THE PROBLEMS AND THE CURRENT BASELINE
Description of the problems
During the development of the CLP, the intention was to keep the classification and labelling
criteria as close as possible to the UN GHS, to facilitate worldwide trade while protecting
human health and the environment (CLP recitals 5 to 8, 12, 13, 15 and 42). However, the
Fitness Check of chemicals legislation other than REACH95
found shortcomings in the
legislative framework with respect to its coherence, because of the lack of horizontal
identification criteria for certain hazard properties. This has resulted in the following identified
problems:
 hazard properties not covered by CLP and the UN GHS, not being identified, classified
and communicated to downstream users, linked to hazardous substances and mixtures
not identified and causing diseases and pollution and consumers and professional users
not provided with sufficient information;
 inconsistencies in risk mitigation measures adopted for substances with the same
hazards but regulated by different pieces of legislation, linked to insufficient
compliance and excessive administrative burden (in particular SMEs);
 failings in triggering risk management provisions in downstream sector-specific
regulations and directives referring to CLP hazard classification,96
linked to hazardous
substances not identified and causing diseases and pollution;
 inefficiencies in the use of limited resources, as the same hazard properties are assessed
multiple times for the same substances according to different regulations, linked to
inefficient procedures for hazard classification and insufficient compliance and
excessive administrative burden (in particular SMEs).
Ultimately, these inconsistencies undermine the protection of human health and the
environment and have been acknowledged by the CSS which lists, amongst other actions:, to
‘propose to establish legally binding hazard identification of endocrine disruptors, based on the
definition of the WHO, building on criteria already developed for pesticides and biocides, and
apply it across all legislation’;, ‘propose new hazard classes and criteria in the CLP to fully
address environmental toxicity, persistency, mobility and bioaccumulation’; and ‘propose to
introduce, adapt or clarify criteria/hazard classes in UN GHS’ (EC, 2020a97
).
Endocrine disruption
The World Health Organisation defines an endocrine disruptor (ED) as ‘an exogenous
substance or mixture that alters function(s) of the endocrine system and consequently causes
95
SWD(2019) 199.
96
Around 20 different legislative acts referring to CLP classifications were identified and analysed in RPA et al.
(2017b).
97
COM(2019) 640 final. Brussels, 11.12.2019
189
adverse health effects in an intact organism, or its progeny, or (sub)populations’ (IPCS,
2002).98
Over the last 30 years, the endocrine disrupting properties of chemicals have been the focus of
increasing scientific research, and the accumulated knowledge identifies EDs as a concern to
public and wildlife health (WHO/UNEP, 2013;99
Vandenberg LN, Turgeon JL, 2021). The
high and increasing incidence of many endocrine-related disorders in humans – such as asthma,
birth defects, neurodevelopmental disorders, cancer, diabetes and obesity in children and
cardiovascular diseases, cancer, diabetes and obesity, allergic and autoimmune diseases in
adults – have important parallels in some wildlife populations. Evidence on the roles played in
the disease outcomes by environmental and other non-genetic factors, including chemical
exposure, is growing. Some links have become apparent (e.g. polychlorinated biphenyls’
exposure as a risk factor in breast and prostate cancers; relationships between perfluoroalkyl
substances and child and adult obesity, impaired glucose tolerance, gestational diabetes,
reduced birthweight, reduced semen quality, polycystic ovarian syndrome, endometriosis, and
breast cancer) while more research is necessary on the associations between EDs and other
endocrine-related diseases (WHO/UNEP, 2013; Kahn et al., 2020).
The interaction between EDs and other environmental stressors is also under investigation,
with some research pointing to potential emerging problems (for example, Wu et al., 2022
report on the negative impact on fish populations of the synergetic action of increasing water
temperatures due to climate warming and endocrine disruption from plastic pollution).
Importantly, only a small proportion of the chemicals on the market have been tested for
endocrine effects and the disease risk due to EDs’ exposure may be significantly
underestimated (WHO/UNEP, 2013). Shaffer et al. (2019) identifies EDs as a high priority
class of environmental health risk factors for inclusion in the future iterations of the Global
Burden of Disease (GBD) study.100
Since 1999, the European Commission has been working on prioritising suspected EDs for
evaluation, monitoring exposures and effects, develop and validate new testing methods and
increase public awareness on EDs (EC, 2018b101
).
Identification of known or presumed endocrine disruptors (EDs) is required for actives
substances by the Plant Protection Products Regulation (PPPR)102
and for actives substances
and products by the Biocidal Products Regulation (BPR)103
according to criteria established,
respectively, in 2017 and 2018. REACH does not contain identification criteria for EDs, but
these are identified as substances of very high concern (SVHCs) on a case-by-case basis
98
International Programme on Chemical Safety. (2002). Global assessment on the state of the science of endocrine
disruptors. World Health Organization. https://apps.who.int/iris/handle/10665/67357
99
UNEP State of the Science of Endocrine Disputing Chemicals - IPCP-2012, available at:
https://www.unep.org/resources/publication/state-science-endocrine-disputing-chemicals-ipcp-
2012?_ga=2.148289463.183897156.1643356524-1526509983.1643356524
100
Shaffer RM et al. (2019): Improving and Expanding Estimates of the Global Burden of Disease Due to
Environmental Health Risk Factors. Environmental Helath Perspectives 127(10) October 2019. Available at:
https://doi.org/10.1289/EHP5496
101
COM(2018) 734 final.
102
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning
the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and
91/414/EEC. OJ L 309, 24.11.2009.
103
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the
making available on the market and use of biocidal products. OJ L 167 27.6.2012.
190
following the IPCS/WHO definition and the assessment of the “equivalent level of concern”
carried out by the REACH Member State Committee. It should be noted that the same
definition and guidelines are used by REACH, BPR and PPPR.
Sector-specific legislation on cosmetic products, medical devices, food contact materials,
detergents, toys or on any other chemical products does not require the identification of EDs.
However, the use of potential endocrine disrupting substances may be subject to the scientific
opinion of expert advisory bodies. For example, while Regulation (EC) No 1223/2009 on
cosmetic products104
(CPR) does not have specific provision for endocrine disruptors, it does
ban the use of substances that are toxic to reproduction (which may for some substances also
be toxic via an endocrine disrupting mode of action); the scientific committee on consumer
safety (SCCS) addresses scientific concerns about the endocrine-disrupting properties (as well
as reprotoxicity and other properties of concern) of cosmetic ingredients through specific risk
assessments.
Because the lack of CLP on EDs is not filled by systematic identification in other regulations,
there is incomplete information on the human health and environmental hazards of these
substances. It should also be noted that EDs are not included at UN GHS. As substances and
mixtures with ED properties are not systematically identified and classified, these properties
are not communicated to downstream users, limiting downstream users’ ability to make
informed purchase choices and to adopt suitable risk management measures. The lack of
identification criteria in CLP may also result in the failure to define risk management
provisions in downstream sector-specific regulations and directives referring to CLP hazard
classification. Moreover, substances suspected of having ED properties may be assessed
multiple times according to different regulations, contributing to the inefficient use of limited
resources.
The inclusion of horizontal criteria for the identification and classification of EDs was
identified as an area for action in the EU's 7th EAP and their absence has been criticized by
many stakeholders (EC, 2020b;105
EC, 2019e106
).
It should be noted though that some stakeholders who participated to the consultation activities
in the framework of the Fitness Check on endocrine disruptors argue that ‘endocrine disruption
is a mode of action, while GHS/CLP focus on adverse effects. Adverse effects triggered by
endocrine activity are already covered by existing GHS/CLP hazard classes. ED classification
would be redundant’. However, not all adverse effects of EDs — for example the effects of
obesogens — can be identified within the current existing hazard classes of CLP.
PBT/vPvB properties
Substances with persistent, bioaccumulative and toxic (PBT) and very persistent, very
bioaccumulative (vPvB) properties do not easily break down in the environment and tend to
bioaccumulate. Even at low toxicity, they have the potential to cause severe harm, because they
build up, for example in the adipose tissue of mammals, increasing their concentration over
time. Once in the food chain, they magnify at each level, leading to higher concentrations in
top predators and humans. Experience has shown that the accumulation of these substances in
104
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on
cosmetic products (Text with EEA relevance).
105
SWD(2020) 251.
106
SWD(2019) 199.
191
the environment is difficult to reverse, as cessation of emission does not readily result in
lowering their concentration, and the effects of this accumulation are unpredictable in the long-
term: in the case of vPvB substances, ‘even if no toxicity is demonstrated in laboratory testing,
long-term effects might be possible since high but unpredictable levels may be reached in man
or the environment over extended time periods’ (ECHA, 2017a107
). Moreover, PBT/vPvB
substances have the potential to contaminate remote pristine areas. They also pose particular
challenges to the reliability of quantitative risk assessment, as a “safe” concentration in the
environment cannot be established with the available methodologies (ECHA, 2017a).
To a certain extent, PBT and vPvB substances are already regulated by REACH: organic
substances placed on the market in quantities of 10 tonnes or more per year have to undergo a
chemical safety assessment (article 14 of REACH), including a PBT/vPvB assessment
according to the identification criteria listed in Annex XIII of REACH. However, any
substance, even those that have not been registered, can be identified as PBT/vPvB and
included in the Candidate List of substances of very high concern (Annex XIV of REACH) for
authorisation of their continued use(s) (article 57 of REACH).
PBT/vPvB substances meeting the criteria set out in paragraph 1 of Annex D to the Stockholm
Convention108
are controlled through the adoption of appropriate measures (article 3(3) of
Regulation 2019/1021 on persistent organic pollutants)109
. Except for explicit exemptions, the
manufacturing, placing on the market and use of substances — on their own, in mixtures or in
articles — is prohibited or restricted if the substances are included respectively in Annex I or
II of the POPs Regulation.
Substances used in veterinary medicinal products and in medicinal products for human use
(both outside the scope of CLP) undergo PBT screening according to European Medicines
Agency’s guidelines110
which refer to REACH Annex XIII criteria. Also the BPR refers to
REACH Annex XIII criteria, but PBT and vPvB substances used in plant protection products
are identified according to the criteria listed in the PPPR. This creates a potential for
inconsistent PBT/vPvB hazard identification, due to differences in the assessment procedures
applied by each legal framework, the interpretation of the criteria, variations in the use of a
weight of evidence approach, the availability of data for the assessment and the regulatory
consequences. This is in particular the case for substances with PBT/vPvB properties near the
trigger values (Rauert et al, 2014; RPA et al. 2017a). Under PPPR, a working Document on
”Evidence Needed to Identify POP, PBT and vPvB Properties for Pesticides”111
has been
developed which follow a different approach than the ones followed in other legislations.
So far, PBT assessments carried out according to the BPR and PPPR have resulted in only one
substance being inconsistently identified as a PBT: acetamiprid112
was identified as “very
107
Guidance on the Application of the CLP Criteria. Guidance to Regulation (EC) No 1272/2008 on classification,
labelling and packaging (CLP) of substances and mixtures. ECHA-17-G-21-EN. Version 5.0 – July 2017.
European Chemicals Agency, 2017.
108
Stockholm Convention on persistent organic pollutants (POPs), available at:
http://chm.pops.int/TheConvention/Overview/TextoftheConvention/tabid/2232/Default.aspx
109
Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent
organic pollutants. Available at: https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX:32019R1021
110
Respectively EMA (2015) and EMA (2018).
111
https://ec.europa.eu/food/system/files/2016-10/pesticides_ppp_app-proc_guide_fate_evidence_identify-pop-
pbt-vpvb-props.pdf
112 EC number: 603-921-1; CAS number: 135410-20-7.
192
persistent” and “toxic” under the BPR and therefore included in the list of candidates for
substitution and approved for seven years only, while it was not identified as “persistent” under
the PPPR and approved for 15 years (EC, 2019e).
The possibility of labelling for PBT/vPvB substances was raised by some MS during the co-
decision process leading to the adoption of CLP and supported by some political groups of the
European Parliament. The proposal did not gain sufficient support, but the legislator decided
to add article 53(2): ‘Member States and the Commission shall, in the manner appropriate to
their role in the relevant UN for a, promote the harmonisation of the criteria for classification
and labelling of persistent, bioaccumulative and toxic (PBT) and very persistent and very
bioaccumulative (vPvB) substances at the level of the UN’ (UN, 2009).113
In 2009, the EU put
forward a proposal to include PBT/vPvB hazard classes and criteria in the UN GHS, but the
UN GHS expert sub-committee concluded that the existing hazard classes for aquatic toxicity
would capture any substance with PBT or vPvB properties and ensure adequate classification
and labelling (EC, 2019e).
It should be noted that hazard classification as intended in CLP and the UN GHS does not
foresee, at the moment, the combination of properties as in PBT or vPvB. ‘Such combinations
of properties are used to trigger specific actions in terms of risk assessment and risk
management’ (UN, 2009). Indeed, while PBT/vPvB substances elicit the same level of concern
as for example CMRs in REACH, CLP and the UN GHS do not provide for horizontal
identification criteria. As a consequence, substances manufactured and imported in quantities
below ten tonnes per year with PBT/vPvB properties — and the mixtures containing these
substances — are not systematically identified and classified and their PBT/vPvB properties
are not communicated to downstream users, limiting their ability to adopt suitable risk
management measures and make informed purchase choices. Moreover, substances suspected
of having PBT/vPvB properties may be assessed multiple times according to different
regulations, contributing to the inefficient use of limited resources. The lack of identification
criteria in CLP results in the failure to define risk management provisions in downstream
sector-specific regulations and directives referring to CLP hazard classification.
PMT/vPvM properties
Substances with PMT/vPvM properties pose grave concerns because they can enter the water
cycle, including drinking water, and spread over long distances, making the determination of
their impacts very challenging114
. Many PMT/vPvM substances are only partly removed by
wastewater treatment processes and can even breakthrough the most advanced purification
processes at drinking water treatment facilities. Their incomplete removal coupled with
ongoing emissions means that their concentrations in the environment increase over time.
Despite progress, current analytical measurements are inadequate, and monitoring may
therefore not detect some of these substances (Hale et al., 2020).
Examples of PMT/vPvM substances are perfluorobutanesulfonic acid (PFBS) and its salts, and
GenX115
, which are compounds belonging to the class of per- and polyfluoroalkyl substances
113 UN committee of experts on the transport of dangerous goods and on the globally harmonized system of
classification and labelling of chemicals, UN/SCEGHS/18/INF.4, available at
https://unece.org/fileadmin/DAM/trans/doc/2009/ac10c4/UN-SCEGHS-18-inf04e.pdf
114
https://enveurope.springeropen.com/articles/10.1186/s12302-020-00440-4
115
Tradename of HFPO-DA (3: 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoic acid) its salts and its acyl
halides.
193
(PFAS). In consideration of ‘the large number of cases of contamination of soil and water -
including drinking water - in the EU and globally, the number of people affected with a full
spectrum of illnesses and the related societal and economic costs’, the CSS stresses that PFAS
require special attention.
The Member State Committee identified two groups of substances (HFPO-DA and PFBS116
)
(2019) and one substance (1,4-dioxane) (2021) as SVHCs and included in the Candidate list
for authorisation according to article 57(f) of REACH, because their individual properties as
well as the combination of their properties elicit an equivalent level of concern, having probable
serious effects to human health and the environment. Hale et al. (2020) applied 16 assessment
criteria117
to three case studies118
to demonstrate that PMT/vPvM substances elicit an
equivalent level of concern of PBT/vPvB substances.
However, neither REACH nor any other legislative framework have identification criteria for
substances with PMT/vPvM properties. Since 2009, the German Environment Agency (UBA)
has been working on the development of identification criteria119
.
Drivers of the problems
The main drivers of the above problems are:
Missing provisions for identification of critical hazards;
Inefficient procedures for hazard classification.
The missing information about critical hazards to human health and the environment is driven
by the lack of horizontal identification criteria and specific hazard classes coupled with
insufficient information on modes of action and fate of the substances. These drivers are
regulatory failures. As CLP does not require the generation of new information (article 8), the
latter driver should be addressed by the revision of the REACH Regulation.
The consequences of having missing information on the hazards of substances and mixtures
are that downstream-users may adopt inconsistent and/or inadequate risk management
measures. Moreover, they can make purchase choices based on partial information. There is a
failure in the functioning of the generic approach to risk management used in many pieces of
legislation, which refer directly to CLP hazard classification for triggering certain risk
116
Remarks: The combined intrinsic properties justifying the inclusion for the Member State Committee as a
substance for which there is scientific evidence of probable serious effects to human health and the environment
which give rise to an equivalent level of concern are the following: persistence, mobility, potential for long-range
transport, observed adverse effects (at least the following probable effects for human health: effects on the liver,
the kidney, and the haematological and immune systems and effects on development; at least the following
probable effects for the environment: population relevant effects on birds and mammals); as well as low adsorption
potential and high water solubility rendering the substance fully bioavailable for uptake via (drinking) water.
Together, these elements lead to a very high potential for irreversible effects
117
Serious effects to human health (Pose a threat to human health; Irreversible health effects; Delayed health
effects; Impaired quality of life). Serious effects to the environment (Irreversible exposure; Irreversible effect;
Intergenerational exposure and effect; Unknown/uncertain spatial scale; Disparity between point of release and
point of effect; Unknown/uncertain temporal scale; Uncertain/difficult to predict long term fate and toxic effects;
Harmful to the aquatic environment; Potential to reach pristine areas). Other effects (Increased societal costs;
Negative effect on resources; Need for minimisation of emissions).
118
PFBS, Gen X and 1,4-dioxane.
119
Umweltbundesamt, PMT and vPvM substances under REACH, https://www.umweltbundesamt.de/en/PMT-
substances
194
management measures. Finally, the lack of horizontal identification criteria contributes to the
inefficient use of the limited resources available.
If the current situation persists, BPR and PPPR will still provide for a systematic identification
of endocrine disrupting active substances according to the criteria established in the BPR and
PPPR. Without policy intervention, the identification of endocrine disruptors used in other
product categories would not be systematic but would still be identified as SVHCs on a case-
by-case basis following the IPCS/WHO definition and the assessment of the “equivalent level
of concern” carried out by the REACH Member State Committee.
PBT/vPvB substances placed on the market in quantities of 10 tonnes or more per year would
be identified according to the criteria listed in Annex XIII of REACH. Even those that have
not been registered could be identified as PBT/vPvB and included in the Candidate List of
substances of very high concern (Annex XIV of REACH) for authorisation of their continued
use(s) (article 57 of REACH).
There are no identification and classification criteria for substances with PMT/vPvM properties
in REACH or any other legal framework, even if under PPPR and BPR specific risk
assessments is triggered for mobile substances. PMT/vPvM substances would be identified
following the assessment of the “equivalent level of concern” carried out by the REACH
Member State Committee according to Article 57(f) of REACH.
The pace of identification under REACH of substances with ED, PBT/vPvB or PMT/vPvM
properties would be largely dependent on resources allocated to SVHC identification. As a
follow-up to the SVHC Roadmap, the IRS started in 2016 with the aim to speed up the
identification of substances of concern, having as a target the assessment of all registered
substances by 2027, to conclude on whether they are a priority for data generation or whether
enough information is available to determine their priority for regulatory risk management
(ECHA, 2021b). As revealed by the exercise carried out by ECHA to provide numbers of
substances that could potentially be identified and classified with ED, PBT/vPvB and
PMT/vPvM properties, for a large number of substances there would be the need for further
data generation, as substances registered with Annexes VII and VIII have in general a very
limited data set.
Based on ECHA work, ‘[at] the end of 2020, there were around 1,860 substances of potential
concern needing further data generation. […] The generation of the data can take anywhere
from less than a year up to several years.’ Further details on this exercise and its methodology
is available in Annex IV.
CLP works as reference for a number of pieces of legislation, and without the introduction of
new hazard classes in CLP, some RMMs which are triggered by harmonised classification and
labelling would not be adopted.
Description of the current baseline
CLP is the horizontal reference point for the identification and classification of the physical,
health and environmental hazards of chemical substances and mixtures for most EU chemicals
and chemicals-related legislation. However, the hazards defined under CLP — and the UN
GHS — are not exhaustive, resulting in lack of communication on the hazards not covered by
CLP.
195
As CLP does not contain hazard identification criteria for substances with ED, PBT/vPvB and
PMT/vPvM properties, under the baseline these substances will keep being identified through
REACH (ED, PBT/vPvB and PMT/vPvM substances), BPR and PPPR (ED, PBT/vPvB
substances). The BPR and the PPPR have established identification criteria for EDs. While
REACH does not contain identification criteria for EDs, these can be identified as SVHCs on
a case-by-case basis following the IPCS/WHO definition and the assessment of the “equivalent
level of concern” carried out by the REACH Member State Committee.
REACH requires registrants to carry out a PBT assessment for substances placed on the market
in quantities of 10 tonnes or more per year. Any substance under the scope of REACH can be
identified according to the criteria listed in Annex XIII of REACH as PBT or vPvB and, as for
EDs, may be identified as SVHCs (article 57 of REACH). The BPR refers to REACH Annex
XIII criteria, and the PPPR contains PBT/vPvB identification criteria.
Neither REACH nor any other legislative framework have identification criteria for substances
with PMT/vPvM properties, but they can be identified as SVHCs under REACH.
ECHA’s integrated regulatory strategy brings together the various regulatory processes of
REACH and CLP. It is based on the efficient selection of substances and groups of substances
that raise potential concern, so that information needed to assess their safety is generated and
any remaining concerns addressed through the most suitable regulatory risk management
measures. ECHA and MSCAs carry out the following substance-specific activities: data
generation and assessment (dossier evaluation, substance evaluation, informal hazard
assessment of PBT/vPvB/ED properties); assessment of regulatory needs (ARN); and
regulatory risk management (harmonised classification and labelling, SVHC identification,
restriction).120
Under the baseline, it is assumed that these activities will keep contributing to the identification
of ED, PBT/vPvB and PMT/vPvM substances. The assessment of regulatory needs may be
based on sufficient available information or on data generated on missing hazard information
following compliance checks, testing proposals and substance evaluation. In addition, the ED
and PBT expert groups support the identification of ED and PBT/vPvB substances.
ECHA and MSCAs select substances that are to be evaluated to clarify whether their use poses
a risk to human health or the environment. The selection is carried out on the basis of risk-
based criteria. The substances selected for substance evaluation (Chapter 2 of the REACH
Regulation) are included in the community rolling action plan (CoRAP) following the opinion
of the Member State Committee. The evaluation of each substance – under substance
evaluation – is carried out by a designated Member State by assessing all registration dossiers
from all registrants specific to the same substance or group of substances, considering other
sources of information and by requesting and assessing new data from the registrants, typically
going beyond the standard REACH information requirements. Following the assessment of all
information, if the evaluating Member State considers that the use of the substance poses a risk,
it may proceed by proposing: harmonised classification and labelling for certain hazards,
identification of the substance as SVHC, an EU-wide restriction, EU-wide occupational
exposure limits, national measures or voluntary industry actions.
120
Planned, ongoing or completed activities are listed in the Public Activities Coordination Tool (PACT).
196
As of February 2022, the CoRAP includes 392 unique substances/entries.121
Between 2012 and
2023, Member States evaluated, are evaluating or plan to evaluate 90 substances for their
suspected ED properties and 151 substances for their suspected PBT/vPvB properties.
Additionally, 23 substances are undergoing an ED assessment under the BPR.122
No data could
be found on the number of substances undergoing an ED or PBT/vPvB assessment under the
PPPR.123
So far, no substances have been included in the CoRAP to investigate suspected
PMT/vPvM properties.
Following data generation (or the evaluation of the available information considered sufficient
for the purpose), the regulatory needs of substances and groups of substances are assessed.124
The outcome can be that either there is no need for action or that regulatory risk management
at EU level is required. The follow-up regulatory actions are: harmonised classification and
labelling, SVHC identification, restriction, or action through other EU legislation. The
assessment can also result in a request for additional data (e.g. through substance evaluation).
As of February 2022, the candidate list of substances of very high concern for authorisation
includes 444 entries, of which 113 were included because of their ED properties, 114 because
of their PBT/vPvB properties and 21 because of their PMT/vPvM properties. It is assumed that
Member States or ECHA would keep proposing substances to be identified as SVHCs at the
same rhythm. It should be noted that the group approach may result in higher numbers of
substances being identified as EDs or with PBT/vPvB or PMT/vPvM properties. Substances
and groups of substances can also be identified for restriction rather than authorisation. The
effect of the inclusion of groups of substances could be large: for example, the announced
intention to submit a restriction proposal for PFAS would affect more than 6,000 substances,125
although only around 2,000 are currently registered.126
Finally, biocidal and plant protection
active substances that exhibit ED or PBT/vPvB properties should not be approved, in
principle,127
for their use in biocidal and plant protection products, in accordance with the BPR
and PPPR.128
By forecasting numbers of substances through linear regression using the known values for the
period 2008-2022, in 2032 the candidate list would include 799 substances, of which 206 for
ED properties, 214 for PBT/vPvB properties and 67 for PMT/vPvM properties. In 2042, the
candidate list would include 1,126 substances, of which 293 for ED properties, 306 for
PBT/vPvB properties and 110 for PMT/vPvM properties (Figure 64).
121
Note that ECHA webpages may indicate a slightly lower number of substances/entries than those listed in the
downloadable list, also because group entries are split in different rows. Source:
https://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-table
122
https://echa.europa.eu/ed-assessment
123
It should be noted that the review under BPR and PPPR is systematic, but limited to ED category 1.
124
As of February 2022, the ARN registry (https://echa.europa.eu/assessment-regulatory-needs) lists 754 entries
between substances and groups of substances, for a total of 2,116 substances. In the downloadable spreadsheet,
group entries are split in different rows. However, not all groups are split (e.g. PFAS has one single row) and
therefore the total number of unique substances is larger. The need for regulatory action, if any, can be identified
for the whole group, a subgroup or a single substance.
125
https://www.rivm.nl/en/pfas/official-start-to-ban-pfas-in-europe
126
https://echa.europa.eu/hot-topics/perfluoroalkyl-chemicals-pfas
127
Derogations are foreseen.
128
The reasons for non-approval of active substances are not easily retrieved from ECHA and EFSA databases, if
not by checking the opinions one-by-one.
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Figure 64: Number of substances included in the candidate list of SVHCs for ED, PBT/vPvB or PMT/vPvM
properties or other hazards per year
Source: ECHA Candidate list (projections of the authors)
As most of the substances may be used in more than one mixture, it is necessary to estimate
the number of mixtures that would be impacted by the identification of a substance with one
or more of the considered properties. Estimating this is difficult for several reasons:
 There is no central repository that compiles information on the number of mixtures for
the entire EU;
 Some of the possible information sources are not publicly available, such as the
information provided to Poison centres for medical emergency129
or the German
Federal Institute for Risk Assessment (BfR).130
Ricardo (2021) estimated that 16,969 substances (including UVCBs) and 190,702 mixtures
would be impacted by the extension of the generic approach to risk management to the
following hazard classes: ED, PBT/vPvB, PMT/vPvM, respiratory sensitisation Cat. 1, 1A and
1B, STOT RE/SE Cat. 1 and 2, immunotoxicity, neurotoxicity, CMR Cat. 2, Skin Sensitisation
Cat 1, 1A and 1B, aquatic chronic 1 and 2 (Ricardo, 2021, p.50). These estimates imply an
average number of mixtures per substance of around 11.
An alternative estimate was derived by analysing the SPIN (Substances of Preparations in
Nordic Countries) and extrapolating the result to the EU.131
The average of five mixtures per
substance was multiplied by a factor of five for projection to the entire EU, resulting in an
average of 25 mixtures placed on the EU market per single substance. This is consistent with
the estimates in the 2017 Fitness Check, which used figures of 99,000 substances and 2.5
million mixtures subject to reclassification, labelling and safety data sheets preparation to
produce an average of about 25 mixtures per substance. Applying these two estimates (11 and
129
https://poisoncentres.echa.europa.eu
130
See e.g. https://www.bfr.bund.de/en/notification_of_products-10144.html, accessed November 2021.
131
The methodology and the results are detailed in the section on the policy options.
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25 mixtures per substance) to the numbers of SVHCs in 2022132
and the estimated number of
SVHCs in 2032 and 2042 produces the estimates for the total numbers of mixtures in Table 26.
Table 27: Estimated number of mixtures containing SVHCs with ED, PBT/vPvB, PMT/vPvM properties
2022 2032 2042
Number of mixtures based on 11 mixtures per substance
ED 100 2,300 3,200
PBT/vPvB 200 2,400 3,400
PMT/vPvM 100 700 1,200
Total 400 5,300 7,800
Number of mixtures based on 25 mixtures per substance
ED 300 5,100 7,300
PBT/vPvB 400 5,300 7,700
PMT/vPvM 200 1,700 2,700
Total 900 12,200 17,700
More accurately, the totals provided in the table relate to the number of classifications for
mixtures rather than the number of mixtures. This is because some mixtures may meet the
classification criteria for more than one of the hazards.
Table 27 summarises the estimates of the numbers of substances and mixtures with ED,
PBT/vPvB, PMT/vPvM properties that would be identified and classified under the baseline.
Table 28: Estimated number of substances and mixtures with ED, PBT/vPvB, PMT/vPvM properties that would
be identified and classified under the baseline
2022 2032 2042
Number of substances*
ED 13 210 290
PBT/vPvB 15 210 310
PMT/vPvM 7 70 110
Total 35 490 710
Number of mixtures**
ED 100 – 300 2,300 – 5,100 3,200 – 7,300
PBT/vPvB 200 – 400 2,400 – 5,300 3,400 – 7,700
PMT/vPvM 100 – 200 700 – 1,700 1,200 – 2,700
Total 400 – 900 5,300 – 12,200 7,800 – 17,700
Notes: *rounded to the nearest tens; **rounded to the nearest hundreds
POTENTIAL POLICY MEASURES
Policy measure 1: Adding new hazard classes.
This measure aims at increasing coherence in the legislation by providing horizontal
identification and classification criteria and providing the opportunity to develop CLH dossiers
for substances classified for these new hazard classes, in order to promote the adoption of
adequate and consistent RMMs for different substance uses, triggering risk evaluations and
restrictions in downstream legislation and lowering exposure to hazardous chemicals in a
timely manner through increasing the number of CLH substances. A detail of can be found in
Table 28.
132
As of March 2022, only 13 EDs, 15 PBT/vPvB and 7 PMT/vPvM SVHCs are still registered, and therefore on
the market.
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Table 29: PO1: Adding new hazard classes.
Policy measure Category Description
Adding ED, PBT/vPvB, PMT/vPvM hazard classes
Add HH and ENV EDs Cat. 1/2
hazard classes
Hard,
legally
binding
rules
The Commission to include HH and ENV EDs Cat. 1/2
hazard classes and identification criteria to Annex I of CLP.
The requirement should enter into force at the same time of
the changes to REACH Annexes to include testing
requirements for endocrine disruption.
Add PBT/vPvB hazard class to
CLP Annex I
The Commission to include PBT/vPvB hazard classes and
identification criteria to Annex I of CLP. The requirement
should enter into force at the same time of the changes to
REACH Annexes to include testing requirements for
PBT/vPvB.
Add PMT/vPvM hazard class to
CLP Annex I
The Commission to include PM/vPvM hazard classes and
identification criteria to Annex I of CLP. The requirement
should enter into force at the same time of the changes to
REACH Annexes to include testing requirements for
PMT/vPvM.
Including ED, PBT/vPvB, PMT/vPvM for CLH
Include HH and ENV EDs
among the substances subject to
CLH
Hard,
legally
binding
rules
The Commission to amend Article 36 of CLP to prioritise
CLH to be proposed for EDs.
Include PBT/vPvB substances
among those subject to CLH
The Commission to amend Article 36 of CLP to prioritise
CLH to be proposed for PBT/vPvB substances.
Include PMT/vPvM substances
among those subject to CLH
The Commission to amend Article 36 of CLP to prioritise
CLH to be proposed for PMT/vPvM substances.
Options discarded
All options involving neurotoxicity and immunotoxicity hazard classes and substances toxic to
the terrestrial environment were discarded at this stage. Indeed, the scale of the problems
caused by these hazards need further investigation, before deciding on the best way to tackle
the problems linked.
Stakeholders consultation
In open text responses to OPC, TSS and in interviews, stakeholders provided different opinions
with regards to policy options listed in this section. It should be noted that stakeholders
provided comments on specific policy options and measures, while some policy options and
measures were not in the focus of stakeholders or were not addressed.
Considering the addition of ED, PBT/vPvB, PMT/vPvM hazard classes, stakeholders were
cautious about the alignment of the new hazard classes with GHS. Mostly business entities
emphasised that the diverging approaches to hazard classes in the EU will put the EU
businesses in disadvantaged competitive position in the global trade because of increasing costs
to adjust to differences in classification and labelling of costs in the EU and in other countries.
Furthermore, stakeholders provided comments about the necessity for clarity in defining
category 2 hazard classes for endocrine disruptors. Business entities highlighted that
communication of hazards of ‘suspected’ endocrine disruptors under category 2 will lead to
so-called black-listing effect of some products. In turn, it could result in reformulation of
products and in some cases, regrettable substitution. Multiple comments with varying opinions
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about legal wording of category 2 were provided by the members of CASG sub-committee of
CARACAL.
Estimation of the number of substances that may be classified as EDs, PBT/vPvB
substances and PMT/vPvM substances
The methodological approach described in Annex IV estimates the number of substances
expected to be classified for ED, PBT/vPvB or PMT/vPvM properties based on information on
23,751 substances in a combined inventory. It is important to reiterate that there are significant
uncertainties on the estimates of the number of substances that may be classified for the new
hazard classes.
Number of ED substances
Based on ECHA WF approach, 80 of the 272 substances corresponding to tonnage level of
Annex X to REACH in basket 2 with potential ED properties are expected to have these
properties confirmed. This estimate implies that ED properties are not confirmed for 192
Annex X substances in basket 2. With the 12 Annex X substances from basket 1, 92 Annex X
substances are expected to be classified as ED substances. This figure is multiplied by 11 to
obtain the projected number of 1,012 ED substances among all substances in the inventory.
ECHA approach estimates the number of substances for which ED properties are already
confirmed (basket 1) or are likely to be confirmed (a subset of basket 2). The total of 1,012
substances is therefore expected to represent confirmed (i.e. Cat. 1) ED substances.
Subsequent analyses aim at differentiating ED Cat. 1 and Cat. 2 and assigning substances to
the envisaged new hazard classes ED HH & ED ENV.
The WFs applied by ECHA to give a point estimate for basket 2 substances likely to be
identified as ED Cat. 1 can be used for deriving lower and upper end estimates of the number
of substances likely to be identified as ED Cat. 1 by using different WF cut-off values. The
lower and upper end estimates do not differ from the ECHA estimate with respect to basket 1
substances but only with respect to basket 2 substances.
Table 29 shows the assignment of ED Cat. 1 to the WF assigned by ECHA. Note again that
this assignment is performed in this impact assessment and was not done by ECHA. The lower
end estimate (AA-1) identifies less substances as ED than the upper end estimate (AA-2).
Table 30: WF assigned by ECHA and derivation of lower and upper end estimates
Substance-specific WF (all possible values)
Substance assigned to category
AA-1 (lower end) AA-2 (upper end)
0.2 Not ED Not ED
0.25 Not ED ED Cat. 1
0.5 ED Cat. 1 ED Cat. 1
0.6 ED Cat. 1 ED Cat. 1
0.8 ED Cat. 1 ED Cat. 1
In the alternative analyses, each substance in basket 1 and basket 2 is identified as being ED
Cat. 1 or as being not ED. This is a major difference with ECHA approach that does not require
the identification of specific substances. The number of substances assigned to each category
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are counted and can be compared to ECHA’s estimate. Table 30 summarises the results of the
estimates.
Table 31: Estimated number of substances expected to be identified as ED Cat. 1
Approach ED Cat. 1
AA-1 836
ECHA 1,012
AA-2 1,276
These numbers represent projections based on the 23,751 unique substances in ECHA’s
combined inventory. Substances identified as ED (ED Total) represent 4.3% (ECHA approach
and central estimate) of the total number of substances in the combined inventory, with a lower-
end estimate representing 3.5% (AA-1) and upper-end estimate representing 5.4% (AA-2).
These analyses suggest a relatively narrow range of the number of substances expected to be
identified as ED.
Categorisation (ED cat. 1 and ED cat. 2)
The new ED hazard classes currently under discussion between experts will involve a
categorisation into ED Cat. 1 and ED Cat. 2. Estimating the number of ED Cat. 2 substances is
associated with a higher uncertainty than the estimate of ED Cat. 1 substances, since there are
no data on which it could be based.
Nonetheless, classifications for reproductive toxicity were evaluated to derive these estimates.
Reproductive toxicity is chosen because:
- Endocrine-mediated effects may result in reproductive toxicity; and
- Classifications for reproductive toxicity differentiate between confirmed (Repr. 1A and 1B)
and suspected (Repr. 2) effects.
It is acknowledged that endocrine-mediated effects may also result in effects on other organ
systems and e.g. manifest themselves in repeated dose toxicity. However, classifications for
repeated dose toxicity (i.e. STOT RE) do not differentiate confirmed and suspected effects.
Harmonised classifications for reproductive toxicity were extracted from Annex VI of the CLP
and the number of self-classifications in REACH registration dossiers was taken from
Karamertzanis et al. (2019). This latter source provides numbers of substances classified either
as Repr. 1A/1B or Repr. 2 at the end of each quarter (i.e. four values per year). The most recent
figures from this publication were used (as per 31 December 2017), but all figures after the
second REACH registration deadline (31 May 2013) show an identical fraction of substances
classified as Repr. 2 (57%) among all those classified for reproductive toxicity). Table 31
shows the results of these evaluations.
Table 32: Fraction of substances classified as Repr. 2 among all those classified for reproductive toxicity
CLH Self-classifications in registration dossiers Total
Repr. 1A/1B 206 464 670
Repr. 2 148 603 751
Total 354 1067 1,421
Fraction of Repr. 2 42% 57% 53%
Repr. 2 / Repr. 1A/1B 0.718 1.30 1.12
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The data show that the fraction of Repr. 2 classifications among all substances with Repr.
classifications is lower in CLH (42%) than it is in registration dossiers (57%). This finding is
not unexpected, since CLH may have a higher focus on confirmed reproductive toxicants while
self-classifications may tend to Repr. 2 classifications, possibly due to a lower degree of
conservatism being applied. Consequently, less substances are classified as Repr. 2 than are
classified as Repr. 1A/1B in CLH, while the opposite is true in self-classifications from
registration dossiers.
The total numbers (i.e. the weighted mean of both datasets) indicate that the number of
substances classified as Repr. 2 is 1.12-times the number of those classified as Repr. 1A/1B.
This figure is taken to estimate the number of substances expected to be classified as ED Cat.
2. For example, the figure of 1,012 substances identified as ED Cat. 1 in the ECHA estimate is
multiplied by 1.12, resulting in 1,133 substances estimated to be ED Cat. 2.
Table 33: Number of substances assigned ED Cat. 1 and ED Cat. 2
Approach ED Cat. 1 ED Cat. 2 Total ED
AA-1 836 936 1,772
ECHA 1,012* 1,133 2,145
AA-2 1,276 1,429 2,705
Notes: * Only this figure was estimated by ECHA (2021a); all other numbers in this row are derived as
explained in the text.
Differentiation by ED effects by impact area (human health, environment)
Two datasets are used to analyse the fraction of substances identified as EDs for the impact
areas of human health (HH) or environmental organisms (ENV) among those identified as ED
(without impact area):
All substances in ECHA basket 1 (including Annex X substances);
Substances assessed as being ED in ECHA’s ED Assessment List. Since this information was
also used in ECHA’s evaluation (i.e. there is a strong overlap between the ED Assessment List
and ECHA’s basket 1), only substances from the ED Assessment List that are not included in
basket 1 are considered for these analyses.
Note that substances identified as having ED effects in both impact areas (HH & ENV) are
assigned to both groups (HH and ENV), since only two hazard classes are envisaged. This
approach is meaningful for estimating the fractions assigned to the two intended hazard classes
ED HH and ED ENV.
Table 33 presents the number of substances per impact area as well as the corresponding
fraction of the total number identified as ED (in brackets) for each of the two datasets. The
second last column shows the sum of the number of substances from the two datasets and the
corresponding fractions. The last column provides estimated fractions that are roughly based
on the fractions obtained for both datasets combined. The last row of the table also indicates
the number of substances in each dataset that is included in each of the two impact areas.
Table 34: Derivation of the fractions of ED substances per impact area
Impact area All ECHA basket 1
substances
ED Assessment List Total Estimate
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HH 13 (41%) 2 (40%) 15 (41%) 40%
ENV 19 (59%) 3 (60%) 22 (59%) 60%
HH & ENV* 8 2
Notes: * Number of substances included in HH and ENV, since these substances are identified as being ED in
both impact areas.
Final estimates
The fractions per impact area derived in the previous section are assigned to the numbers of
substances per category estimated above. The same fraction of 40% (HH) and 60% (ENV) is
assigned in each category.
Table 34 provides the number of substances expected to be identified as ED differentiated by
ED category and impact area among all substances (ECHA basket 3). The last column shows
the total number of substances identified as ED already reported above. As noted earlier, the
impact areas used here are not mutually exclusive: in other words, any given substance may be
counted in HH and ENV.
Table 35: Estimated number of substances expected to be identified as ED with categorisation and
differentiation by impact area
Type of estimate ED Cat. 1 ED Cat. 2 ED Total
HH ENV HH ENV HH ENV All
Lower end (AA-1) 334 502 374 562 708 1,064 1,772
Central estimate (ECHA approach)* 405 607 453 680 858 1,287 2,145
Upper end (AA-2) 510 766 572 857 1,082 1,623 2,705
Notes: * Note again that ECHA only derives the ED Cat. 1 estimate and does not differentiate by impact area.
The sum of 1012 ED Cat. 1 substance is included in ECHA (2021a), but the assignment to HH (N=405) and
ENV (N=607) is performed in this study.
Based on the total number of 23,751 unique substances in ECHA’s combined inventory, the
central estimate of 1,012 substances identified as ED Cat. 1 represents 4.3%. Using the derived
factor of 1.12, an additional 1,133 substances are estimated to be identified as ED Cat. 2 (4.8%
of the combined inventory). In total, 2,145 substances (9.0%) are identified as ED in the central
estimate.
Overall, the high uncertainty of the estimated figures reflects the fact that the data required for
the classification as ED (including categorisation and differentiation by impact area) are not
yet available. It must also be stressed that – even if the estimated numbers prove to be close to
the real numbers – they would only materialise if all necessary studies have been conducted
for all substances. Importantly, information generated by the new Annex VII requirements for
ED testing that may be included in REACH following its revision cannot identify ED category
1 and 2: substances that will have positive in vivo mechanistic information in the follow-up
will not be classified as ED cat 1 or 2 according to CLP. Classification requires both endocrine
activity and adversity: in vivo positive substances will not meet the CLP criteria for ED
category 1 or 2 because data on adversity is missing. However, the new Annex VII
requirements would enable the identification of potential EDs (even if not
classified/classifiable as EDs) and therefore prevent regrettable substitutions, as industry would
be unlikely to substitute a known ED with a substance that as in vivo endocrine activity, i.e. a
very likely ED.
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Moreover, the number of 1,012 potential ED substances was estimated by ECHA by
extrapolating to the full registration database of over 23,000 substances, whereas new
information requirements about ED properties may affect only a subset of the overall number,
leading to the identification and classification of a lower number of substances, and
consequently mixtures.
Number of PBT/vPvB substances
Table 36 summarises the relevant numbers included in ECHA (2021a).
Table 36: Summary of the estimated number of PBT/vPvB substances by ECHA
Annex X substances All substances
Basket 1 Basket 2 total Basket 2* PBT/vPvB total** PBT/vPvB total
PBT 1
vPvB 3
PBT & vPvB 7
PBT/vPvB
Total
11 99 25 36 396
Notes: * Application of the ECHA WF approach (see above). ** Sum of basket 1 and basket 2.
Subsequent analyses are based on the following assumptions:
The size of the WF assigned by ECHA is assumed to be indicative of whether a
substance is identified as PBT/vPvB. This assumption is implicit in the statistical
approach applied by ECHA to derive point estimates of the total number of substances
having this property.
Direct application of WF cut-offs to differentiate PBT/vPvB substances from those that are not
PBT/vPvB at the substance-specific level (rather than in a statistical approach) is valid to derive
lower and upper end estimates. This appears a reasonable assumption, since it directly reflects
the general approach taken by ECHA.
Table 36 shows the assignment of PBT/vPvB categories in this impact assessment to the WF
assigned by ECHA. Note again that this assignment is performed in this impact assessment and
was not done by ECHA. The lower-end estimate (AA-1) identifies less substances as
PBT/vPvB than the upper-end estimate (AA-2).
Table 37: WF assigned by ECHA and resulting classification
Substance-specific WF (all possible values)
Substance assigned to category
AA-1 (lower end) AA-2 (upper end)
0.12 Not PBT/vPvB Not PBT/vPvB
0.3 Not PBT/vPvB PBT/vPvB
0.8 PBT/vPvB PBT/vPvB
The number of substances identified as PBT/vPvB is counted and can be compared to the
ECHA estimate. Table 37 provides the estimates for all three approaches.
Table 38: Estimated number of substances expected to be identified as PBT/vPvB
Approach PBT/vPvB
AA-1 143
205
ECHA 396
AA-2 847
Based on the total number of 23,751 unique substances in ECHA’s combined inventory,
substances identified as PBT/vPvB represent 1.7% (ECHA approach) with a range of 0.60%
(AA-1) to 3.6% (AA-2). These analyses suggest a relatively wide range of the number of
substances expected to be identified as PBT/vPvB (factor 6 between minimum and maximum
estimate). This relatively wide range results from the fact that the majority of the 99 basket 2
substances in the evaluation (N=64, 65%) is assigned a WF of 0.3. These 64 substances are
identified as not PBT/vPvB in AA-1, while they are assigned to the PBT/vPvB group in AA-
2.
Assignment to hazard classes
The ECHA approach does not differentiate PBT and vPvB properties for basket 2 substances.
Since the number of substances per envisaged hazard class (PBT and vPvB) are useful for the
impact assessment, the approach for identifying fractions follows the one applied to assign ED
substances to impact areas. In the case of PBT/vPvB properties, the following datasets are
evaluated:
All substances in ECHA basket 1 (including Annex X substances);133
Substances assessed as being PBT and/or vPvB in ECHA’s PBT Assessment List.134
As noted for ED properties, there is substantial overlap between these datasets, since the PBT
Assessment List was also used as an input for ECHA’s basket 1 evaluation. Therefore,
substances from the PBT Assessment List were only used in this evaluation, if they are not
included in basket 1. Substances identified in these list as being PBT & vPvB (i.e. possessing
both properties) are assigned to each of the two intended hazard classes. Their numbers are
provided in the last row of Table 38. For example, 17 of the 23 substances identified as PBT
among the basket 1 substances are also identified as vPvB. Table 38 summarises the outcome
of these evaluations. The percentages given in brackets are the ones for the hazard class as a
fraction of the sum of both hazard classes.135
Table 39: Fractions of PBT and vPvB substances among those identified as PBT/vPvB
Impact area ECHA basket 1 substances PBT Assessment List Total Estimate**
PBT 23 (45%) 6 (46%) 29 (45%) 45%
vPvB 28 (55%) 7 (54%) 35 (55%) 55%
PBT & vPvB* 17 2
Notes: * Number of substances included in PBT and vPvB, since these substances are identified as being both
PBT and vPvB. ** Roughly based on fraction obtained in the evaluation of all three datasets.
The data show that more than half of the substances identified as PBT are also identified as
vPvB (see ECHA basket 1 substances). This is not true for the substances from the PBT
133
As noted above, the ECHA evaluation of substances in basket 2 does not differentiate by impact area.
134
https://echa.europa.eu/de/pbt, accessed 6 November 2021.
135
Since substances with both PBT and vPvB properties are assigned to both hazard classes, the theoretical number
of ‘substances’ in these evaluations are higher than they actually are. Thus, there are 11 Annex X substances in
basket 1: 1 PBT, 3 vPvB and 7 PBT & vPvB). The 7 substances are assigned to both hazard classes, resulting in
8 PBT and 10 vPvB substances. This results in 18 theoretical ‘substances’, of which 8 (44%) are PBT and 10
(56%) are vPvB.
206
Assessment List that are not already included in basket 1, but in this case the sample size is
very small. The estimated percentages in the last column of the table are used as a pragmatic
approach to assign substances to the envisaged new hazard classes PBT and vPvB, since the
fractions obtained in the two datasets are practically identical. However, these fractions involve
a high uncertainty, since they are based on small samples. The estimated fractions are assigned
to the total number identified as PBT/vPvB, resulting in a final estimate of the number of
substances for these hazard classes.
Final estimates and discussion
Table 39 summarises the final estimates, providing the split into the two envisaged hazard
classes for the central estimate representing the total number of expected PBT/vPvB substances
derived in ECHA (2021a) (N=396) as well as a lower-end (N=143) and an upper-end estimates
(N=847). It is important to note that ECHA did not provide separate estimates for PBT and
vPvB substances. This allocation was carried out by the consultants supporting the impact
assessment.
Table 40: Final estimate on the number of substances expected to be classified as PBT and vPvB
Type of estimate PBT vPvB PBT/vPvB total
Lower end (AA-1) 64 79 143
Central estimate (ECHA approach) 178 218 396
Upper end (AA-2) 381 466 847
These numbers represent very rough estimates. As already noted, the apparent accuracy of the
estimates is spurious. The calculated numbers are provided to increase transparency and to
allow cross-checking of the calculations. The uncertainties of these estimates relate to the
following issues:
ECHA (2021a) considers basket 3 estimate (i.e. the figure of 396 substances expected to be
identified as PBT/vPvB) as a guestimate and therefore highly uncertain.
Bioaccumulation in air-breathing (terrestrial) animals is currently not fully assessed since
assessment approaches are still under development. Substances that do not bioaccumulate in
aquatic organisms may do so in terrestrial mammals, potentially increasing the number of
PBT/vPvB substances. Also, further developments in bioaccumulation assessment of ionisable
substances may also result in changes of the number of substances to be considered as ‘B’ (both
issues are also stated in ECHA (2021a) as limitations).
ECHA evaluation is largely based on sources listing substances with on-going assessments for
PBT/vPvB properties. The listing of possible PBT/vPvB is presumably often based on
screening criteria and the concerns may not be confirmed upon further investigation. For
example, the PBT/vPvB properties of 52 substances assessed by the PBT Expert Group
between 2012 and 2018 were only confirmed in 15 cases (29%) (ECHA, 2019a). This is likely
to be the reason for the low WFs (0.12 or 0.3) assigned in the ECHA evaluation for many of
the sources included.
The split among the two envisaged hazard classes appears robust based on the datasets
evaluated. However, it must be noted that the total number of substances in these datasets is
small and the assignment to the two hazard classes therefore includes an additional element of
uncertainty.
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Based on the total number of 23,751 unique substances in ECHA’s combined inventory, the
396 substances identified as PBT/vPvB in the central estimate represent 1.7% with a range of
0.60%-3.6%. An earlier screening approach noted a fraction of PBT/vPvB substances of about
3%-5% among 95,000 chemicals (Strempel et al., 2012). Simple screening approaches may
identify a higher fraction of substances as PBT/vPvB substances than will be identified upon
further investigation.136
The findings of this screening exercise may therefore not be in
contradiction with the numbers estimated here. Finally, the PBT assessment in REACH
registration dossiers currently identifies 8,279 entries as not PBT/vPvB and 97 as PBT/vPvB.137
The latter constitute 1.2% of the total (N=8,376), a figure that falls within the estimated range
and close to the central estimate of 1.7%. The assignment to the two envisaged hazard classes
is uncertain.
Number of PMT substances
Table 41 summarises the relevant numbers included in ECHA (2021a).
Table 41: Summary of the estimated number of PMT/vPvM substances by ECHA
Annex X substances All substances
Basket 1 Basket 2 total Basket 2* PMT/vPvM total** PMT/vPvM total
PMT 0
vPvM 0
PMT & vPvM 0
PMT/vPvM Total 0 84 21 21 231
Notes: * Application of the ECHA WF approach (see above). ** Sum of basket 1 and basket 2*.
Subsequent analyses follow the same approach as described above for PBT/vPvB properties.
Table 41 shows the assignment of PMT/vPvM categories in this impact assessment to the WF
assigned by ECHA. Note again that this assignment is performed in this impact assessment and
was not done by ECHA.
Table 42: WF assigned by ECHA and resulting classification
Substance-specific WF (all possible values)
Substance assigned to category
AA-1 (lower end) AA-2 (upper end)
0.1 Not PMT/vPvM Not PMT/vPvM
0.3 Not PMT/vPvM PMT/vPvM
0.8 PMT/vPvM PMT/vPvM
The number of substances identified as PMT/vPvM can be compared to the ECHA estimate.
Table 42 provides the estimates for all three approaches.
136
This suggestion also corresponds to the experience of the PBT Expert Group, in which a PBT/vPvB concern
identified based on screening approaches was not confirmed.
137
Based on a simple evaluation of the information given in ECHA’s database on registered substances:
https://echa.europa.eu/information-on-chemicals/registered-substances, evaluated on 15 November 2021. Entries
can be filtered by the ‘PBT assessment outcome’ and the resulting numbers were extracted for the entries rated as
‘PBT/vPvB’ and ‘not PBT/vPvB’. These numbers only relate to substances for which a PBT assessment according
to the REACH Regulation is required. Furthermore, other possible results of the PBT assessment (e.g. when
further information is necessary) were not considered.
208
Table 43: Estimated number of substances expected to be identified as PMT/vPvM
Approach PMT/vPvM
AA-1 0
ECHA 231
AA-2 693
The alternative analysis AA-1 does not identify any substance as being PMT/vPvM, since:
 No Annex X substance with these properties is included in ECHA’s basket 1; and
 No substance with a WF of 0.8 exists among Annex X basket 2 substances.138
While it
is entirely unrealistic that no substance will be classified for PMT/vPvM properties, the
approach applied in this study does not allow estimating the respective number.
Consequently, no lower-end estimate can be provided.
These analyses suggest a relatively wide range of the number of substances expected to be
identified as PMT/vPvM (none or almost 700 substances). Like for PBT/vPvB properties, this
relatively wide range results from the fact that the majority of the 84 basket 2 substances in the
evaluation (N=63, 75%) is assigned a WF of 0.3. These 63 substances are identified as not
PMT/vPvM in AA-1, while they are assigned to the PMT/vPvM group in AA-2.
Impact of the log Koc cut-off values and assignment to hazard classes
The current139
proposal by the European Commission for the mobility assessment suggests a
decrease of the cut-off values proposed by the German UBA from log Koc < 4 to log Koc < 3
(‘M’ criterion) and from log Koc < 3 to log Koc < 2 (‘vM’ criterion).140
The impact of such a
change is discussed here in the context of the allocation of the number of substances to the two
envisaged hazard classes PMT and vPvM.
ECHA evaluation does not differentiate PMT and vPvM properties for basket 1 or basket 2
substances. Furthermore, an assessment based on an ECHA list (as shown above according to
the PBT Assessment List) is not possible, since a ‘PMT Assessment List’ does not exist.
Therefore, an evaluation like the one performed for PBT/vPvB properties is not feasible.
Therefore, analyses based on log Koc are performed, which is currently proposed as the sole
parameter for the mobility assessment. In principle, such evaluations could be based on log
Koc values reported in ECHA’s database on registered substances. However, there are several
limitations to such an approach:
 For any given substance, several log Koc values may exist. In such situations, the data
would need to be evaluated and a single value (or an adequate range) be derived.
 The log Koc values reported may be predicted values in a substantial number of cases
and log Koc predictions may also be reported for substances that are outside the
applicability domain of the models used. Again, an evaluation/curation step would be
necessary prior to using such values for the purpose of this study.
138
A WF of 0.8 is only assigned to two substances in basket 2 that are not registered under REACH Annex X.
139
As of December 2021.
140
Referred to as ‘UBA criteria’ and ‘COM criteria’ below.
209
Based on these limitations and the timeframe of this study, a different approach is applied that
uses a dataset of substances registered under REACH. This dataset was previously evaluated
for a study on emerging chemical risks in the food chain for the European Food Safety
Authority (Oltmanns et al., 2019; Oltmanns et al., 2020).141
The dataset of 2,336 substances
(hereinafter ‘EFSA dataset’) was generated from all substances registered under REACH,
excluding intermediate registrations and NONS (considered registered under REACH). The
dataset was further limited to substances that have an assigned CAS number and are likely to
be within the applicability domain of the models used in the EFSA study to predict
biodegradation and bioaccumulation in food or feed. The data curation and evaluation steps
excluded metals, metalloids, organometallic substances, inorganic and ionisable substances
and ensured that a reliable SMILES notation was available.
The SMILES notations of these 2,336 substances were used to predict log Koc in the KOCWIN
(v. 2.01) module of the US EPA’s EpiSuite (US EPA, 2011). Both KOCWIN models were
used: one being based on log Kow and the second one being based on the molecular
connectivity index (MCI), resulting in two log Koc values for each of the 2,336 substances.
For each substance, the minimum and the maximum value were derived. The following
evaluations are performed for both the minimum and the maximum log Koc value per
substance. Furthermore, experimental log Koc data in this software were extracted and
analysed.
In a first evaluation, the substances identified as M/vM in the EFSA dataset were compared
with respect to the origin of the log Koc and the two different criteria for the cut-off. Table 43
provides the results of this evaluation, showing that 66%-75% of the substances have a
predicted log Koc <4 and would be considered M/vM according to the UBA criteria. When
experimental log Koc values are used, this fraction increases to 80%. These percentages are
slightly lower than the fraction quoted in ECHA (2021a) (81%) based on running QSAR
models on a very large database (performed by the Dutch RIVM; no further details are
provided). The data also show that 49%-62% of the substances have predicted log Koc values
<3 and would therefore meet the Commission’s criteria. Again, these fractions are somewhat
lower than the fraction quoted in ECHA (2021a) (65%), which in turn is lower than the one
based on experimental values.
Reducing the log Koc (as in the Commission proposal) results in a decrease of the substances
identified as M/vM by 11-25%. While the effect is less pronounced for the experimental log
Koc values (from EpiSuite), the dataset is comparatively small (N=136). Giving less weight to
this lower percentage, a reduction of the fraction of M/vM substances due to the lower log Koc
cut-offs proposed by the European Commission is likely to be in the range of about 15-25%
(rounded). This finding is similar to preliminary estimates quoted in ECHA (2021a) from
which a reduction by about 20-35% can be inferred.142
In contrast to the preliminary and
unpublished findings quoted in the report, however, the data presented here are based on a
single dataset using three different sets of log Koc values.
141
The full dataset, including SMILES notations is available at: https://zenodo.org/record/2613616#.YYaDJ7oo-
Uk, accessed 5 November 2021.
142
The report quotes unpublished evidence that about 81% of chemicals have log Koc < 4, while 65% have a log
Koc < 3 and 41% have a log Koc < 2. Thus, lowering the log Koc cut-off from 4 to 3 results in 16% less chemicals
being identified as ‘M’ (a reduction by 16%. A higher reduction can be inferred for vM properties.
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Table 44: Summary of substances identified as M/vM based on the EFSA dataset
Basis UBA criteria* COM criteria* Reduction by**
Minimum predicted log Koc 1,755 (75%) 1,449 (62%) 306 (17%)
Maximum predicted log Koc 1,534 (66%) 1,145 (49%) 389 (25%)
Experimental (from EpiSuite) log Koc 109 (80%) 97 (71%) 12 (11%)
Notes: * These percentages refer to the fraction of the total dataset (N=2336; N=136 for experimental data).
** These percentages refer to the reduction by applying the COM criteria (e.g. 306 / 1755 = 17%).
For more detailed analyses, each of the 2,336 substances was rated as ‘M’ or ‘vM’ according
to the different sources (minimum, maximum or experimental log Koc) and the two
classification schemes (i.e. different cut-offs for log Koc). Table 44 summarises the results of
these analyses and highlights the fraction of substances considered only mobile (M, but not
vM) among those considered M/vM. It also shows the total numbers already provided in Table
43.
Table 45: Summary of the mobility assessment of the EFSA dataset according to log Koc criteria and source
of the value
Basis UBA criteria COM criteria
Minimum predicted log Koc
vM 1,449 936
M 306 513
Total M/vM 1755 1,449
M (but not vM), fraction of total M/vM 17% 35%
Maximum predicted log Koc
vM 1,145 642
M 389 503
Total M/vM 1,534 1,145
M (but not vM), fraction of total M/vM 25% 44%
Experimental (from EpiSuite)
log Koc
vM 97 51
M 12 46
Total M/vM 109 97
M (but not vM), fraction of total M/vM 11% 47%
Weighted mean M (but not vM), fraction of total M/vM 21% 39%
Overall estimate
M (but not vM), fraction of total
M/vM
20% 40%
vM (but not M), fraction of total
M/vM
80% 60%
Use of the maximum log Koc increases the fraction of substances considered ‘M’ (but not
‘vM’) compared to use of the minimum log Koc. This finding is not surprising, since a
substance with – for example – a minimum log Koc of 1.5 and a maximum log Koc of 2.5 will
move from the ‘vM’ group to the ‘M’ group under the Commission’s criteria. The same trend
is observed if the UBA criteria are applied.
Lowering the log Koc cut-offs by one log unit in the Commission’s criteria (when compared
with the UBA criteria) also has the expected effects of a lower number of substances identified
as M/vM and a higher fraction of substances considered ‘M’ (but not ‘vM’) among those
identified as M/vM. The experimental log Koc show a similar pattern, but the small number of
experimental data limit the findings of this evaluation. Overall, the fraction of substances to be
considered ‘M’ (but not ‘vM’) among those identified as either ‘M’ or ‘vM’ is 20% if the UBA
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criteria are applied and is 40% if the Commission’s criteria are applied. Consequently, 80% of
these substances are considered ‘vM’ according to the UBA criteria, and 60% are considered
‘vM’ according to the Commission’s criteria. Combining both the impact of lowering the log
Koc cut-offs and assigning substances identified as PMT/vPvM to either of the two envisaged
hazard classes is a complex issue. We apply the following approach:
 Although ECHA estimate of the number of substances identified as PMT/vPvM is
apparently largely based on the UBA criteria, the total number of 231 is not reduced.
This approach accounts for the suggestion in ECHA (2021a) that the number of basket
2 substances ‘may to some extent underestimate the number of potential PMT/vPvMs’.
The assignment to either of the two hazard classes is performed based on the fractions derived
above with respect to the Commission’s criteria and the UBA criteria. Using the Commission’s
criteria, 40% of the 231 substances identified as PMT/vPvM (N=92) are assigned to the PMT
group, while 60% (N=139) are assigned to the vPvM group in the ECHA approach.
Table 45 summarises the resulting split between PMT and vPvM substances.143
Table 46: Estimated number of substances expected to be classified as PMT and vPvM based on the
Commission’s criteria and comparison with UBA criteria
Approach PMT vPvM
EC UBA EC-UBA EC UBA EC-UBA
ECHA 92 46 +46 139 185 -46
AA-2 277 139 +138 416 554 -138
Applying the Commission’s criteria for log Koc therefore results in a shift of 46 substances
from the vPvM group to the PMT group in the ECHA approach (139 substances in the AA-2
approach).
The key assumption in using the figures to differentiate between ‘M’ and ‘vM’ substances for
these estimates is that a shift from ‘vM’ to ‘M’ equals a shift from vPvM to PMT. This
assumption is not entirely valid, since it may concern substances that are not toxic.
Consequently, such substances would rather move from the ‘vPvM’ hazard class to no hazard
class. This assumption cannot be verified based on the approach of this study since the
projections do not relate to specific substances. Such evaluations would in principle be possible
for basket 2 substances, but this would require an analysis of log Koc values (see discussion
above) as well as a review and evaluation of the toxicity data for each substance. These analyses
are not possible given their resource-intensive nature and the timeframe of this study.
Data from a UBA study (Arp and Hale, 2019) aiming to predict the number of substances that
would be identified as PMT/vPvM are therefore used to further analyse this issue. This study
estimated the number of REACH registered substances (as of 2017) that would be identified
as PMT (N=58), vPvM (N=47) and PMT & vPvM (N=155), resulting in a total of 260
substances. If the group PMT & vPvM is added to both the PMT and the vPvM group, 213
substances (51%) are assigned to the PMT group and 202 substances (49%) to the vPvM group
(percentages relate to the total of 415 theoretical substances). In contrast to the approach based
on the EFSA dataset, these figures better reflect all properties (i.e. persistence, mobility and
toxicity) and the underlying dataset also includes some substances excluded from the EFSA
143
As explained above, no lower end (AA-1) estimate can be provided.
212
dataset (e.g. ionisable substances). However, mobility in this study was assessed on the basis
of the UBA criteria for log Koc.
Figure 65 illustrates the division into the two hazard classes for the 231 substances identified
as PMT/vPvM in the ECHA approach (left plot) and for the 693 substances from the upper end
(AA-2) approach. In both plots:
 the left columns show the estimates derived in this study using the split to PMT and
vPvM of 40% and 60%, respectively, derived from dataset of 2,336 substances using
the Commission’s criteria for log Koc cut-offs;
 the central columns show the estimates derived in this study using the split to PMT and
vPvM of 20% and 80%, respectively, derived from dataset of 2,336 substances using
the UBA criteria for log Koc cut-offs; and
 the right columns show the estimates derived in this study using the split to PMT and
vPvM of 51% and 49%, respectively, derived from the UBA study (Arp and Hale,
2019).
Figure 65: Number of substances assigned to the two hazard classes. Left: total number of PMT/vPvM
substances based on ECHA estimate (N=231); right: total number of PMT/vPvM substances based on upper
estimate AA-2 (N=693)
The split into PMT and vPvM according to the UBA criteria results in 1.3 times more vPvM
substances than the one based on the Commission’s criteria, because of the differences noted
in the evaluation of the dataset of 2,336 substances (i.e. 80% vs. 60%; see above). The number
of PMT substances is consequently lower. In both cases, this split is derived from an evaluation
of the EFSA dataset that only addresses log Koc as the mobility criterion with the limitation
discussed above. The split from the Arp and Hale (2019) covers all three relevant properties as
well as some groups of substances not covered by the EFSA dataset, but is based on the UBA
criteria for log Koc. The number of substances assigned to the vPvM group is lower in the
UBA split than in both other approaches, reflecting the lower fraction of 49% compared to 60%
and 80% based on Commission’s and UBA criteria (see above). Table 46 shows the number of
substances plotted in Figure 65 for easier reference.
Table 47: Estimated number of substances expected to be classified as PMT and vPvM based on different splits
between PMT and vPvM
Approach PMT vPvM
EC criteria UBA criteria UBA
split
EC criteria UBA criteria UBA
split
ECHA
(N=231)
92 46 119 139 185 112
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AA-2
(N=693)
277 139 356 416 554 337
Notes: Unrounded percentages were used for splitting all PMT/vPvM substances between the two hazard
classes.
These evaluations demonstrate that the numbers assigned to PMT and vPvM hazard classes
based on the Commission’s criteria range between those derived with the UBA criteria and the
ones calculated using the split derived from the UBA study. The numbers resulting from the
split using the COM criteria are used in this study for the following reasons:
They range between the other two approaches but are closer to the numbers derived by using
the split from the UBA study than the ones derived using UBA criteria on the EFSA dataset.
The split derived from the UBA study may be considered somewhat less uncertain than the
ones derived from the EFSA dataset (using Commission’s or UBA criteria for the log Koc cut-
offs). However, the UBA split is based on UBA criteria for log Koc cut-offs, and the number
derived using this split are not taken directly. The fact that the numbers estimated using the
Commission’s criteria are closer to the ones calculated with the UBA split than the ones using
the UBA criteria supports the derivation used here.
The central estimate based on the total number of 231 expected to be classified as PMT/vPvM,
as derived in ECHA (2021a), results in a lower number of vPvM substances based on the
Commission’s criteria (N=139) compared to the UBA criteria for log Koc (N=185).144
However, the upper end estimate derived in this study for this hazard class based on
Commission’s criteria (N=416) is more than 2-times higher.
Final estimates
Table 47 summarises the final estimates, providing both a central estimate representing the
total number of expected PMT/vPvM derived in ECHA (2021a) (N=231) as well as an upper-
end estimate (N=693) and the split into the two envisaged hazard classes as derived above.
Possible ranges for the split are indicated in brackets but are not used in the impact assessment.
Table 48: Final estimate on the number of substances expected to be classified as PMT and vPvM
Type of estimate PMT/vPvM PMT vPvM
Central estimate (ECHA approach) 231 92 (46-119) 139 (112-185)
Upper-end estimate (AA-2 approach) 693 277 (139-356) 416 (337-554)
These numbers represent very rough estimates. As noted earlier, the apparent accuracy of the
estimates is spurious, but the numbers are provided to increase transparency and to allow cross-
checking of calculations. The uncertainties of these estimates relate to the following issues:
 ECHA (2021a) considers the basket 3 estimate (i.e. the figure of 231 substances
expected to be identified as PMT/vPvM) as a guestimate and therefore highly uncertain.
 For PMT/vPvM properties, the ECHA assessment is largely based on lists compiled by
other authors with most substances coming from a study by the Danish Technical
University (DTU) that almost exclusively relied on predicted data with respect to
persistence, mobility and toxicity (Holmberg et al., 2021). In fact, all Annex X
144
Note that the 46 substances move from the vPvM to the PMT group under the COM criteria.
214
substances in basket 2 used to estimate the upper end (N=63 substances, multiplied by
11, resulting in 693 substances) come from this source. Predicted properties are
considered uncertain (as is also suggested by the low WF assigned). The upper-end
estimate may therefore turn out to be an overestimate.
The log Koc values used in the analyses of this study also represent predicted values and the
above analyses illustrate the differences between e.g. the use of minimum and maximum log
Koc values. The associated uncertainty has an impact on:
 the comparison of Commission’s criteria for the mobility assessment with those
proposed by UBA;
 the fraction assigned to the envisaged hazard classes PMT and vPvM.
It must be noted, however, that other approaches to estimate the number of PMT/vPvM
substances also largely rely on predicted log Koc values. In fact, the DTU study employed
three different prediction models to assess mobility, together with two persistence models and
several approaches to assess toxicity (Holmberg et al., 2021).
The evaluation of log Koc values in this study and their impacts on the mobility assessment
using different cut-offs as well as the assignment to the two envisaged hazard classes is limited
by the fact that it covers almost exclusively mono-constituent neural organic substances. This
limitation also applies to the DTU study as noted in ECHA (2021a). The complexity of the
mobility assessment e.g. for ionisable substances and UVCBs is therefore not covered by this
assessment.
The 231 substances identified as PMT/vPvM in the central estimate represent 1% of the total
number of 23,751 unique substances in ECHA’s combined inventory. This estimate is in line
with an earlier estimate by the German UBA that 260 of the 15,469 REACH registered
substances (around 1.7%) would be identified as PMT/vPvM substances (Arp and Hale, 2019).
If the information from the UBA study is linearly extrapolated to the 23,751 substances in
ECHA’s combined inventory, 399 substances would be identified as PMT/vPvM substances.
This value is substantially lower than the upper end estimate used in this study (N=693). This
comparison increases the confidence in the estimates derived in this study.
The DTU study (Holmberg et al., 2021) produces several different outcomes depending on the
models chosen to assess persistence and mobility (both entirely based on predictions). The
number of substances identified in this screening exercise as potential PMT/vPvM substances
in a dataset of 2,073 REACH registered mono-constituent chemicals ranged from 53 (2.6%) to
262 (13%). These fractions are substantially higher than estimated here or in the UBA study
(Arp and Hale, 2019). Most likely, this difference is due to the sole reliance of predicted values.
Holmberg et al. (2021) considered a set of 29 substances as deserving scrutiny by regulatory
agencies, since these substances were identified in the DTU approach as well as in an earlier
UBA study performed by the Norwegian Geotechnical Institute (NGI). If these 29 substances
are taken as an indication of the substances that would be classified as PMT/vPvM (out of the
2,073 substances evaluated) in the future, the resulting fraction of 1.4% is in line with the
estimates presented above.
However, according to Holmberg et al. (2021), the substances identified as PMT/vPvM
differed in most cases from the ones by NGI in in the earlier UBA study. The differences noted
are due to differences in substance selection and methodological differences in data generation
and evaluation. However, even if only substances included in the NGI list and the DTU list are
considered, only about one fourth of the substances identified as PMT/vPvM in the NGI list
215
are also identified by DTU as PMT/vPvM (the 29 substances mentioned above). This
comparatively low level of agreement is due to the different methods in predicting PMT/vPvM
properties.
Overall, given the uncertainties discussed and the different approaches applied to estimate the
number of PMT/vPvM, the alignment of the estimates in this study with the ones in the UBA
study is noteworthy. The upper-end estimate provided here – although not specifically
addressing these uncertainties – may be considered a reflection of the high overall uncertainty
in deriving figures for the number of substances with PMT/vPvM properties and the assignment
to the two envisaged hazard classes.
SCREENING AND ASSESSMENT OF THE POTENTIAL MEASURES
Economic, social and environmental impacts of policy option 1a: adding new hazard
classes
Direct and indirect costs of the introduction of new hazard classes in CLP
A cost-benefit analysis requires that the relevant costs (those with policy action minus the costs
of the baseline) accruing to any agent affected by the policy — including manufacturers and
importers of chemicals, downstream users, public authorities and consumers — are estimated.
Cost also relates to any loss of human wellbeing: for example, if the actors substitute the newly
classified chemicals with alternatives that are safer from a human health perspective but are
less efficient from a technical perspective, then the loss of beneficial use of the chemicals
constitutes a cost. Ideally, understanding and calculating who bears the costs involve a dynamic
general equilibrium model of the chemicals sector and beyond. Such a detailed model is not
available, and therefore costs are estimated rudimentary by multiplying number of chemical
products (substances and mixtures) to be classified, notified and labelled, and the unit costs for
classification, notification and labelling. These are referred to as the direct costs of CLP.
Table 49 provides the total number of substances under low, main, and high estimate scenarios
that are:
Already known to meet the proposed criteria for classification for each hazard;
Are expected to be identified by ongoing assessment (mainly under REACH) as meeting the
proposed criteria; and
Are expected to be identified in the future by a combination of further information generation
under REACH and/or prioritisation processes yet to be applied to the substances.
The methodological approach to estimating the number of substances expected to be classified
for ED, PBT/vPvB or PMT/vPvM properties has been summarised in the sections above. As
already mentioned, these numbers have been derived to inform the impact assessment and are
associated with substantial uncertainty owing to the fact that the final criteria required for the
classification as ED (including categorisation and differentiation by impact area) and for
mobility are not yet fully available. Separate legislative proposals to alter the information
requirements under REACH to include ED are being examined in the separate study ‘Gather
further information to be used in support of an Impact Assessment of potential options, for the
update of REACH Annexes for inclusion of data requirements on endocrine disruption’. It
216
must be stressed that – even if the estimated numbers prove to be close to the real numbers –
they would only materialise if all necessary studies have been conducted for all substances.
Table 49: Estimated number of substances expected to be identified as ED (with
categorisation), PBT/vPvB and PMT/vPvM
Type of estimate
Lower end
(AA-1)
Central estimate
(based on ECHA
approach)
Upper end
(AA-2)
ED Cat. 1 HH 334 405 510
ENV 502 607 766
ED Cat. 2 HH 374 453 572
ENV 562 680 857
ED Total HH 708 858 1 082
ENV 1 064 1 287 1 623
All* 1 772* 2 145* 2 705*
PBT 64 178 381
vPvB 79 218 466
PBT/vPvB tot. 143 396 847
PMT 46** 92 277
vPvM 112** 139 416
PMT/vPvM
tot. 158** 231 693
As noted in Ricardo (2021), ‘the inclusion of new hazard classes in CLP will not result in an
immediate EU-harmonization of classifications to the new hazard classes. The process will
take place gradually, following the harmonised classification and labelling (CLH) processes
and subject to the existing or newly generated evidence necessary to support classification, as
well as resource availability from authorities’.
It is assumed that policy option 1a would enter into force in 2023 and, as a consequence, those
substances already identified as entailing these hazards would have to be classified and labelled
accordingly. As presented in the baseline, 113 substances have been identified as having ED
properties, but only 13 are still registered and therefore on the market, although for some
substances currently classified as toxic to the reproductive system there may be already
sufficient information for a classification as EDs. While CLP requirements cover all
substances, including those not registered, the main driver to the identification of EDs will be
the inclusion of additional testing requirements in REACH and the follow-up activities to the
screening of the chemical universe of registered substances to identify substances of concern
carried out in the framework of the IRS by ECHA and MSCAs. It is assumed that the inclusion
of ED testing requirements in REACH would result in the identification of ED substances over
time, as registrants submit testing proposals and generate information, and ECHA carries
compliance check, testing proposal examination and substance evaluation and ask for
additional data. Indeed, many substances would be identified through follow-up activities by
ECHA and MSCAs, e.g. asking for additional or different tests. It is assumed that the new
hazard classes — or better, the new endpoints — will be included among those endpoints145
for which scoping review, compliance check and request of missing information are always
145
So-called ‘super endpoints’: genotoxicity, repeated-dose toxicity, pre-natal development toxicity, reproduction
toxicity, carcinogenicity, long-term aquatic toxicity, biodegradation and bioaccumulation.
217
performed. As illustrative examples, a typical PBT battery of simulation, bioaccumulation and
aquatic toxicity may take between three to five years to carry out. A basic Extended One-
Generation Reproductive Toxicity Study (EOGRTS) study takes minimum two years and
requires assessment prior to testing and again afterwards to check test compliance. Moreover,
companies may face limited laboratory capacity to contract the testing, further delaying the
generation and checking of data.146
It is likely that also for PMT/vPvM substances there will be generation of new data, following
the revision of REACH information requirements to ensure adequate data for classification.147
For PBT/vPvB properties, it is assumed that the REACH Annex XIII identification criteria are
moved to Annex I of CLP, but the requirement for a PBT/vPvB assessment remain for
substances manufactured or imported in quantities of 10 tonnes or more per year per registrant
(Article 14 of REACH).
In summary, the substances that are expected to be (self-)classified, labelled and notified for
the new hazard classes will be identified through the generation of new data because of new
information requirements and follow up activities by ECHA and MSCAs. Table 50 shows the
lower end, central, and upper end estimates of the number of substances that could have the
considered properties
Table 50: Number of substances expected to be classified for the new hazard classes
ED PBT/vPvB PMT/vPvM
Number of substances – lower end estimate 1,772 143 158
Number of substances - central estimate 2145 396 231
Number of substances – upper end estimate 2,705 847 693
More accurately, Table 50 relates to the number of classifications for substances rather than
the number of substances. This is because some substances may meet the classification criteria
for more than one of the hazards. To account for such overlap, ECHA’s estimates for the Basket
1 (confirmed) and Basket 2 (pending conclusion) substances have been examined. For these
Basket 1 and 2 substances the identity of substances is known and hence it is possible to identify
which substances meet (or are being considered may meet) classification for one, two or three
of the hazards (ED, PBT/vPvB and PMT/vPvM). The extent of this overlap is described in
Table 51. This suggests that, of the 936 substances identified in Basket 1 or 2 by ECHA, 801
meet (or may meet) criteria for one hazard, 128 for two of the hazards and 7 for three. Thus,
for 801 of the substances, a single hazard is captured in any cycle of re-classification for a
substance, for 128, two hazards are captured in any cycle of reclassification and for 7, three
hazards are captured resulting in an average of 1.15 hazards per substance. To account for this
overlap when calculating costs per hazard identified, costs of the actions required have been
adjusted to 87% of the unit costs.
Table 51: Overlap in substances meeting one or more hazard criteria
Number of substances
on Basket 1 or 2
Number of hazards
considered
Number with one new hazard classification 801 1
146
See the final report of the supporting study to ‘Gather Further Information to be Used in Support of an Impact
Assessment of Potential Options, for the Update of REACH Annexes for Inclusion of Data Requirements on
Endocrine Disruption’.
147
Currently information requirements for simulation tests in soil and sediment and adsorption desorption can be
waived if the substance is not adsorptive.
218
Number with two new hazard classifications 128 2
Number with three new hazard classifications 7 3
Total substances/hazards 936 1,078
Hazards per substance 1.15
Adjustment factor 0.87 (1/1.15)
Economic impacts of PO1a
PO1a: Administrative costs on businesses and conduct of business
Under PO1a, manufacturers and importers of substances meeting classification for one or more
of the hazards would be required to classify the substances accordingly. Action would also be
required to provide a notification to the CLI and communicate to downstream users by means
of labelling and revised SDS. In turn, formulators that are incorporating the substance into
mixtures would have to carry out mixture classification and label mixtures accordingly and
provide necessary documentation to SDS. Depending on the outcomes, mixtures might also be
reformulated. The unit costs of these activities are provided in Table 51 and adjusted by the
factor of 0.87 for correct application to information on the number of substances identified with
each hazard (see Table 50). The cost of classification and SDS revision of PBT/vPvB
substances is not accounted for, as PBT/vPvB assessment is already obligatory under REACH,
although it applies to substances manufactured and imported in quantities above 10 tonnes per
year per registrant only. Also for EDs, the cost of classification and SDS revision is not
accounted for, as ‘the inclusion of a substance in the Candidate List for authorisation due to
concerns for endocrine disrupting effects triggers additional provisions for risk assessment
(Chemical Safety Report) and risk communication (Safety Data Sheet)’ (EC, 2020b).
Table 52: Unit costs of actions for manufacturers and importers of substances (per substance par company)
Cost Element
Base value
used in
calculations
As adjusted
(87%)
Euro (2022)
Classification of a single substance according to CLP € 400 € 347.31 € 378
Cost of re-labelling in line with CLP € 388 € 336.89 € 367
Cost of notification* € 7.20 € 6.25 € 7.4
Total cost of classification, labelling and notification of
PMT/vPvM substances
€ 795 € 752
Total cost of labelling of ED and PBT/vPvB substances € 395 € 367.54 € 374
Cost of updating and distributing revised SDS € 250 € 217.07 € 237
Source: RPA et al. (2017b, p. 72)
Notes: *0.18 hours at €40.5 per hour
For ED and PBT/vPvB substances, the information is already required to be included in the
SDS, so this cost is not accounted for.
Total cost of classification, labelling and notification of substances
The unit costs of classification, labelling and notification are expressed on a per substance per
company basis and so require consideration of the number of companies
manufacturing/importing each substance. The ECHA information on the identity of the Baskets
1 (confirmed) and 2 (pending) substances has been compared with REACH registration
database data on the number of active registrations. From these data, the average number of
registrants by company size can be extracted for each of the hazards. These data are provided
219
in Table 52 and suggest that there are 11.19 companies on average for substances with ED
properties, 6.14 for PBT/vPvB and 6.7 for PMT/vPvM.
Table 53: Average number of companies (and percentage) with an active registration per substance by
company size
Micro Small Medium Large Total
ED 0.16 (1.4%) 0.32 (2.9%) 0.68 (6.0%) 10.03 (89.7%) 11.19
PBT/vPvB 0.04 (0.6%) 0.21 (3.3%) 0.42 (6.9%) 5.47 (89.2%) 6.14
PMT/vPvM 0.05 (0.7%) 0.24 (3.6%) 0.54 (8.1%) 5.87 (87.6%) 6.70
Overall 0.09 (1.1%) 0.27 (3.2%) 0.56 (6.7%) 7.38 (89.0%) 8.30
The data on the number of substances expected to meet each hazard criterion, the average
number of companies for each hazard type (Table 52) and unit costs of the activities (Table 51)
provides estimates of the total cost of classification, labelling and notification for each one of
the three scenarios (Table 53).
Table 54: Total cost of classification, labelling and notification (and SDS revision)
ED PBT/vPvB PMT/vPvM Total
Lower end estimate €7,421,125.99 €329,100.23 €1,047,288.48 €8,797,514.70
Central estimate €8,983,247.89 €911,354.49 €1,531,162.27 €11,425,764.65
Upper end estimate €11,328,524.72 €1,949,285.99 €4,593,486.81 €17,871,297.52
Total cost of PO1a for substances
Table 54 provides the total cost of all activities in relation to PO1 for manufacturers and
importers of substances, combining cost from updating and distributing revised SDS and cost
of classification, labelling and notification, assuming that all the substances expected to meet
the criteria for classification according to the new hazard classes will be identified over a period
of 20 years. Table 54 provides the present value — discount rate of 3% — of the total costs for
companies of different size and in total for the number of substances meeting the criteria.
Table 55: Present value of the total cost of PO1-a for substances - (20 years, discount rate: 3%)
Lower end (AA-1) Micro Small Medium Large Total
Lower end € 8,000 €17,000 € 36,000 €530,000 € 591,000
Central estimate € 5,000 €26,000 € 53,000 €685,000 € 768,000
Upper end € 9,000 €43,000 € 97,000 € 1,052,000 € 1,201,000
Costs of PO1a to manufacturers and importers of mixtures
Manufacturers and importers of mixtures containing substances identified as meeting
classification for ED and/or PBT/vPvB and/or PMT/vPvM would have to carry out mixture
classification and label mixtures accordingly. For PMT/vPvM substance, manufacturers and
importers would have to revise and provide necessary documentation in SDS. Depending on
the outcomes, mixtures might also be reformulated.
Number of mixtures per substance
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Table 55 shows the estimates of the number of mixtures containing substances identified with
ED, PBT/vPvB and/or PMT/vPvM properties, obtained by applying the two factors (11 and 25
mixtures per substance) presented in the baseline.
Table 56: Number of mixtures for all substances with new hazard class
Factor: 11 ED PBT/vPvB PMT/vPvM
Lower end estimate 19,492 1,573 1,738
Central estimate 23,595 4,356 2,541
Upper end estimate 29,755 9,317 7,623
Factor: 25 ED PBT/vPvB PMT/vPvM
Lower end estimate 44,300 3,575 3,950
Central estimate 53,625 9,900 5,775
Upper end estimate 67,625 21,175 17,325
Unit costs
The unit costs of the CLP activities in relation to mixture manufacturers and importers are
provided in Table 56 and adjusted by the 0.87 factor to account for the overlap created by some
substances having more than one identified hazard. The costs of the activities are largely
expressed per mixture per company. For the purpose of this assessment, it has been assumed
that each mixture is manufactured uniquely by one company. Thus, all cost expressed per
mixture per company are applied on a per mixture basis. The cost of the classification of
mixtures containing ED and PBT/vPvB substances and the cost of updating and distributing
revised SDS is not accounted for, as part of the baseline.
Table 57: Unit costs for mixtures
Cost Element
Base value used
in calculations
As adjusted
(87%)
Euro
(2022)
Classification of a single mixture according to CLP € 200 € 174.00 € 190
Cost of re-labelling in line with CLP € 475 € 412.43 € 449
Cost of updating and distributing revised SDS € 250 € 217.07 € 237
Cost of classification, labelling and SDS of mixtures
containing PMT/vPvM substances
€ 925 € 803.5 € 876
Cost of classification and labelling of mixtures containing
ED, PBT/vPvB substances
€ 675 € 586.43 € 639
Re-formulation of mixtures due to changes in hazard
classification
€ 15,000 € 13,024 € 14,182
Source: RPA et al. (2017b, p. 72)
Notes: it is assumed that classifying mixtures requires half of the time of classifying substances, as it entails the comparison
of concentration limits.
The introduction of new hazard classes in CLP also entails indirect costs for businesses, in the
form of substitution of chemical substances and reformulation of mixtures and withdrawal from
the market of substances and mixtures that may be classified.
As noted by Ricardo (2021), ‘These reclassifications could also have indirect impacts, for
example, companies may consider product discontinuation or substitution (e.g., as seen for
CMR in fast moving consumer goods, fluorinated substances in food packaging in Denmark,
etc.). This is driven by non-legislative pressures such as the SIN-list, pressure from retailers,
expectations from consumers and professionals, ecolabelling schemes, etc.’.
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There are two basic approaches to risk management often used in combination, in the EU
chemicals acquis: one based on specific risk assessment and the other one based on generic
risk considerations (GRC). The main difference between these two approaches is the point in
time when the exposure assessment is considered and the specificity of the exposure
assessment. For risk management based on GRC, the potential exposures and risks are
considered generically, prior to the adoption of legislation. The GRC-based approach is built
into the legislation in the form of an automatic trigger of pre-determined risk management
measures (e.g. packaging requirement, communication requirement, restrictions, bans, etc.)
based on the hazardous properties of the chemical determined under CLP, without the need or
possibility to assess and take into account specific exposure levels for a specific situation or
use. Companies consulted in the context of the Ricardo (2021) study estimated that around
43% of their product portfolio would be affected by the inclusion of new hazard classes to CLP
and the extension of the GRC-based approach. Indeed, substances and mixtures reclassified for
the new hazard classes would be affected by the application of the GRC-based approach, where
a CLH triggers the restriction or ban of a classified substance for some specific or all uses. This
impact should be accounted for by the parallel studies supporting the revision of the REACH
Regulation.148
Some products will not be directly affected by changes to the application of the GRC-based
approach, but CLP classification and labelling for the new hazard classes may still put pressure
for market withdrawal or substitution and reformulation. The “total potentially affected
portfolio” considers the inclusion of hazard classes for immunotoxic and neurotoxic substances
in addition to ED, PBT/vPvB and PMT/vPvM, and also the extension of the GRC-based
approach to consumer and professional uses via REACH restriction and sector specific
legislation to respiratory sensitisers and STOT RE/SE, immunotoxic and neurotoxic
substances, skin sensitisers 1, 1A and 1B, CMR 2 and substances toxic to the aquatic
environment with long lasting effects (chronic) 1 and 2. The portion of the products that is
affected by changes to CLP and not the GRC-based approach is estimated as 31% of the total
potentially affected product portfolio in terms of turnover (Ricardo, 2021, p.59).
Moreover, Ricardo (2021) assumes that a quarter (25%) of the products not affected by the
GRC-based approach but directly by CLP would face indirect market pressure to substitute and
reformulate or withdraw from the market (Ricardo, 2021, p.59). Participants to the bespoke
survey of Cefic business members in the context of the Ricardo (2021) study reported that they
would be able to substitute and/or reformulate around 35% of the products (in terms of
turnover) that may be affected by the changes to the GRC-based approach application and CLP.
These two percentages are used as lower (9%)149
and upper (25%) bounds of the number of
mixtures that would be reformulated as a result of the classification for ED, PBT/vPvB and
PMT/vPvM properties.
Ricardo (2021) estimates that CLP could be responsible for the reduction of 1% of the total
potentially affected portfolio, equivalent to around €5.8 billion.150
However, this figure should
be considered as illustration of the size of the sectors involved rather than an indicator of
economic losses. A better measure would be the ‘value added foregone’, which could be
estimated by subtracting the cost of all inputs except capital and labour from the production
148
In particular, the “Study to support the impact assessment for potential amendments of the REACH Regulation,
to extend the use of the generic risk management approach to further hazard classes and uses, and to reform
REACH authorisation ad restriction” (GRO/IMA/21/2123/12108).
149
35% of 25% of mixtures.
150
Information provided by Cefic in response to a request by the European Commission.
222
value. But even this measure cannot be treated as costs in a cost-benefit analysis or cost-
effectiveness analysis, and it is certainly not comparable to compliance costs. Whether the
‘value added foregone’ is a cost depends on whether the production factors (capital and labour)
can be productively re-employed or not.
Cost of classification, labelling, SDS revision and reformulation for mixtures
The cost of classification, labelling and SDS revision for mixtures is calculated by combining
the estimates of the number of mixtures in Table 55 with the unit costs for mixtures in Table
56. A range between 9% and 25% of the total number of mixtures are assumed to be
reformulated. This provides the estimated costs in thousands of euros (Table 58) for numbers
of substances identified.
Table 58: Total cost of classification, labelling, SDS revision and reformulation of mixtures
Factor: 11
Reformulation: 9%
ED PBT/vPvB PMT/vPvM Total
Lower end estimate €405,081,092.00 €17,931,330.74 €24,143,460.76 €447,155,883.49
Central estimate €490,349,290.25 €49,655,992.81 €35,298,350.85 €575,303,633.91
Upper end estimate €618,365,888.18 €106,208,651.28 €105,895,052.55 €830,469,592.01
Factor: 11
Reformulation: 25%
ED PBT/vPvB PMT/vPvM Total
Lower end estimate €877,537,246.96 €38,845,087.86 €48,932,209.57 €965,314,544.38
Central estimate €1,062,255,866.10 €107,571,012.53 €71,540,129.18 €1,241,367,007.80
Upper end estimate €1,339,581,406.90 €230,082,443.46 €214,620,387.53 €1,784,284,237.89
Factor: 25
Reformulation: 25%
ED PBT/vPvB PMT/vPvM Total
Lower end estimate €920,638,845.44 €40,753,024.40 €54,871,501.72 €1,016,263,371.56
Central estimate €1,114,430,205.12 €112,854,529.10 €80,223,524.66 €1,307,508,258.89
Upper end estimate €1,405,377,018.58 €241,383,298.36 €240,670,573.99 €1,887,430,890.93
Factor: 25
Reformulation: 25%
ED PBT/vPvB PMT/vPvM Total
Lower end estimate €1,994,402,834.00 €88,284,290.58 €111,209,567.20 €2,193,896,691.78
Central estimate €2,414,217,877.50 €244,479,573.92 €162,591,202.67 €2,821,288,654.10
Upper end estimate €3,044,503,197.50 €522,914,644.23 €487,773,608.02 €4,055,191,449.75
Total cost of PO1a for mixtures
Table 58 provides the total cost of all activities in relation to PO1a for manufacturers and
importers of mixtures, combining cost from updating and distributing revised SDS and cost of
classification and labelling, assuming that a range between 9% and 25% of the total number of
mixtures will be reformulated.
Table 59 provides the present value — discount rate of 3% — of the total costs for companies
of different size and in total for the number of mixtures meeting the criteria.
Table 59: Present value of the total cost of PO1-a for mixtures (20 years, discount rate: 3%) – rounded to the
nearest thousand
Factor: 11
Reformulation: 9% Micro Small Medium Large Total
Lower end estimate € 424,000 € 860,000 € 1,814,000 € 26,958,000 € 30,056,000
Central estimate € 230,000 € 1,294,000 € 2,650,000 € 34,496,000 € 38,669,000
Upper end estimate € 409,000 € 1,999,000 € 4,527,000 € 48,885,000 € 55,821,000
Factor: 25
Reformulation: 9% Micro Small Medium Large Total
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Lower end estimate € 963,000 €1,954,000 € 4,124,000 € 61,268,000 € 68,309,000
Central estimate € 522,000 €2,941,000 € 6,023,000 € 78,399,000 € 87,885,000
Upper end estimate € 930,000 €4,543,000 €10,289,000 € 111,103,000 € 126,865,000
Factor: 11
Reformulation:
25% Micro Small Medium Large Total
Lower end estimate €914,000 € 1,856,000 € 3,917,000 € 58,197,000 € 64,884,000
Central estimate €495,000 € 2,792,000 € 5,719,000 € 74,433,000 € 83,439,000
Upper end estimate €880,000 € 4,294,000 € 9,727,000 €105,031,000 €119,932,000
Factor: 25
Reformulation:
25% Micro Small Medium Large Total
Lower end estimate €914,000 € 1,856,000 €3,917,000 € 58,197,000 € 147,464,000
Central estimate €495,000 € 2,792,000 €5,719,000 € 74,433,000 € 189,635,000
Upper end estimate €880,000 € 4,294,000 €9,727,000 € 105,031,000 € 272,573,000
Grand total costs of PO1
The grand total cost of the inclusion of the new hazard classes is the sum of the costs of
classification, labelling, notification and SDS revision of substances and mixtures and the
reformulation of mixtures. The central estimate of the present value (discount rate: 3%) is in
the range €39M - €190M, with a lower end estimate of €30M and an upper end estimate of
€273M.
Table 60: Present value of the grand total costs of CLP activities on PO1-a (discount rate: 3%)
Reformulation: 9% of mixtures Reformulation: 25% of mixtures
Based on 11
mixtures per
substance
Based on 25
mixtures per
substance
Based on 11
mixtures per
substance
Based on 25
mixtures per
substance
Total – Lower end €30,647,000 € 68,900,000 €65,475,000 € 148,055,000
Total - Central estimate €39,437,000 € 88,653,000 €84,207,000 € 190,403,000
Total - Upper end €57,022,000 € 128,066,000 € 121,133,000 € 273,774,000
Notes: rounded to the nearest million
The cost estimates are sensitive to the assumptions made on the number of mixtures per
substance and the percentage of mixtures that would be reformulated.
Public authorities: Change in costs to the Commission, ECHA and MSCAs
In the coming years, the Commission, ECHA and MSCAs are expected to keep the current
level of resources dedicated to chemical risk management. The introduction of new hazard
classes in the CLP Regulation — in itself — does not entail a cost for administration but will
result in a higher number of substances identified as EDs or with PBT/vPvB and PMT/vPvM
properties being subject to further regulatory risk management actions, ‘competing’ with
substances classified for other hazards of concern.
This subsection presents a discussion over the amount of resources that would be required to
prepare CLH dossiers for the number of substances that could be identified as EDs or with
PBT/vPvB and PMT/vPvM properties.
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ECHA has made an estimate of the resources required for development of CLH dossiers
including the average time and other resources required per dossier. The development of a CLH
dossier for ED/PMT/PBT hazard classes is of higher complexity than the average CLH. This
is summarised in Table 60 and results in an estimated average cost per CLH of €120,500.
In the notes supporting its estimate, ECHA identify that ‘dossier development’ cost component
has two key stages:
- the collection of data for proposing the hazard classes; and
- the drafting of the dossier.
ECHA identifies that the first stage of collecting the data will be the most challenging in respect
of time management and experience in literature searching and data collection as it will require
the need to acquire/access proprietary data and maybe the necessary access rights to do this.
The second stage of drafting the report is identified as being more manageable.
Table 61: ECHA’s estimate of resources for supporting the preparation of a complex CLH dossier
ECHA estimate for CLH
Dossier development 0.5 FTE
RAC opinion making 0.1 FTE
Support services 0.05 FTE
Total FTE 0.65
1 FTE staff costs including 19% overhead cost and infrastructure €170,000
Total cost of the above €110,500
Contribution to RAC organisation cost €10,000
Total €120,500
The estimate of the average cost of developing CLH for a substance can now be applied to the
number of substances. According to the analysis, the following estimated numbers of
substances may be identified as meeting classification for each of the identified hazards. As
noted earlier, there is overlap between the proposed hazard classes such that some substances
may have more than one classification. In earlier parts of the analysis, it was estimated that, on
average, each substance may be identified with 1.15 hazard classifications151
. Thus, the number
of substances implied is adjusted to provide the estimated number of CLH dossiers, giving a
central estimate of 2,407 (ranging between 1,800 and 3,686). This assumes that there is no
grouping of substances, and each substance would require its own CLH dossier. It also does
not take account of the fact that some of the substances may already have a hazard classification
that requires that a CLH dossier is developed (such as CMR 1A/1B).
Table 62: Number of substances for CLH
Lower end (AA-1)
Central estimate (ECHA
approach)
Upper end (AA-2)
ED Total 1,772 2,145 2,705
PBT/vPvB total 143 396 847
PMT/vPvM 158 231 693
Total hazard / substance
combinations
2,073 2,772 4,245
Implied substances 1,800 2,407 3,686
151
It is important to note that, considering hazard classes other than ED, PBT/vPvB and PMT/vPvM, the average
number of hazard classes covered by a CLH dossier is three (analysis of CLH up to CLP ATP17).
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The resulting cost estimates are provided in Table 62. It should be noted that, whilst the costs
provide an estimate of the financial cost of the undertakings, they do not consider the
practicality of producing such large numbers of CLH proposals within a framework that
currently produces 50 to 60 CLH dossiers per year. Here ECHA notes that the feasibility of
the work needs to be seen in the light of resources that would be available to ECHA as
opposed to the total amount of activities (under REACH and CLP) that are foreseen for
ECHA to carry out.
ECHA also notes that the estimates are of limited scalability, meaning that in case of a
relatively high demand (e.g. additional >10 CLH per year) additional overhead will need to be
looked at.
Table 63: Costs of CLH proposal development under PO1-c
Number of Substances /
CLH proposals
ECHA estimate
for CLH cost
Present value (20
years, 3%)
Lower end (AA-1) 1,800 € 198,900,000 € 13,400,000
Central estimate (ECHA approach) 2,407 € 266,000,000 € 17,900,000
Upper end (AA-2) 3,686 € 407,300,000 € 27,400,000
Considering a 20-year period, dossier submitters (ECHA, MSCAs and industry actors)152
would have to prepare additional 120 CLH dossiers per year (central estimate; 90-184 CLHs
per year), and ECHA and RAC would have to process them. Annualised costs (20-year period,
3% discount rate)153
would sum up to €17.9 million. In terms of human resources, to prepare
and process the additional number of CLH dossiers in 20 years, dossier submitters would
require additional 60 FTEs per year (ECHA estimate) (CI: 45-92 FTEs), ECHA support
services would require 6 FTEs (CI: 5-9 FTEs) and RAC would require additional 12 FTEs per
year (CI: 9-18 FTEs).
To put these numbers in perspective with the current capacity, with the current rate of dossier
of 50 per year, on the period 2023-2042 (20 years), only 1,000 dossiers will be produced.
Assuming that 50% of all CLH dossiers in the next 20 years will cover one or more new hazard
classes, dossier submitters would require 13 FTEs per year, ECHA support services would
require 1 FTE per year and RAC would require additional 3 additional FTEs per year. The
present value is €3.7M (period: 20 years; discount rate: 3%).
In addition, the ED and PBT hazard classes are expected to impact the BPC work on the
approval of biocidal active substances. The BPC, based on the peer review of the conclusion
of the biocide evaluating Competent Authority, is concluding on ED/PBT identification of
biocidal active substances. After the introduction of ED and PBT hazard classes, the hazard
identification would rely on the harmonised classification under CLP, at least for the cases
where there is a trigger for classification. This would be similar to what happens for CMR
classification.
In the review programme there are approximately 200 biocidal active substances that still
require ED assessment. The BPC is progressing with the evaluation, and it expects to review a
152
The number of CLH dossiers submitted by industry actors is very small.
153
As recommended by Tool #64 of the Better Regulation Toolbox (EC, 2021c, p.555).
226
minimum of 15 substances per year. Assuming that the new hazard classes are introduced in
2023, there may be still around 175 substances154
for review of ED properties. For some
substances, the entry in BPC peer review may be delayed awaiting the harmonised ED and
PBT classification. The BPC will have to ensure a smooth interplay with the CLH process.
The BPR only refers to substances having endocrine-disrupting properties (article 5(1)(d)), but
it is assumed that in analogy with other hazard classifications, only Cat. 1 will be considered
for exclusion criteria. For PBT, the confirmation of two criteria (out of the three P, B or T) is
enough for being identified as candidate for substitution.
This impact assess for the BPC will impact in a similar way EFSA which asses endocrine-
disrupting properties and PBT for active substances in PPP. Moreover, the revision of REACH
will touch upon other tasks of public authorities and of RAC. Synergies will be identified. This
is why no costs are entitled for PO1a when it comes to public authorities, including ECHA.
Territorial impacts (specific regions)
During the consultation activities for this supporting study, stakeholders have highlighted that
some chemical products produced in specific regions of the EU may come within the scope of
classification as ED category 2.155
Many are mainly consumer products, and stakeholders fear
that a classification as ED would result in a drastic decrease in the demand for these products,
with very severe socio-economic impacts on the economy of the interested regions.
Impacts on SMEs
The overall cost of PO1a according to the different assumptions used (reformulation rate and
number of mixtures per substance) has been assessed against the number of persons employed
in each enterprise per company size (Table 63),156
to obtain an ‘average cost per employee’
(the ‘SME test’)157
.
Table 64: Main aggregates of NACE code C20 Manufacture of chemicals and chemical products per company
size
Micro Small Med. Large Total
Number of enterprises 19,447 5,242 2,504 793 27,986
Turnover € 10,133M €34,648M € 118,957M €414,870M €600,000M
Persons employed 47,000 119,331 278,071 735,156 1,200,000
Turnover per person employed 215,596 290,353 427,794 564,330 500,000
The average administrative burden of PO1a per person employed per year for a large enterprise
is €20.1 while for SMEs is €4, assuming a reformulation rate of 9% and 11 mixtures per
substance. Assuming a reformulation rate of 25% and 25 mixtures per substance, the average
administrative burden of PO1 per person employed per year for a large enterprise would be of
€97.2 per year, while for SMEs would of €19.6.
Table 65: Average cost (central estimate) per person employed per company size
154
There may be 2-3 new active substances per year, although only a fraction of these substances may have
positive triggers for ED/PBT harmonised classification.
155
For example, see Ramsey et al. 2019; Kalyan S, 2007; Dean CJ, 2007.
156
Eurostat Structural business statistics – Industry by employment size class (NACE Rev. 2, B-E) – NACE code
C20 Manufacture of chemicals and chemical products.
157
In line with Better Regulation Guideline’s Tool #23.
227
Assumptions / company size Micro Small Medium-
sized
Large
Reformulation 9% - 11 mixtures per substance € 1.3 € 3.3 € 7.6 € 20.1
Reformulation 25% - 11 mixtures per substance € 2.7 € 7 € 16.3 € 43
Reformulation 9% - 25 mixtures per substance € 2.9 € 7.3 € 17.1 € 45.3
Reformulation 25% - 25 mixtures per substance € 6.2 € 15.8 € 36.8 € 97.2
The underlying cost estimates suggest no disproportionate effects on SMEs versus large
enterprises. It should be noted that small and medium-sized formulators (manufacturers of
mixtures), depending on their product portfolio and market (industrial users vs professional
users vs consumers) may be significantly affected by the inclusion of the new hazard classes.
Concerns have been raised on the inclusion of a category 2 for ‘suspected’ EDs, which may
capture a high number of consumer chemical products put on the market by SMEs, often
concentrated in specific EU regions. Such a classification may result in drastic decrease in the
demand for these products, with very severe socio-economic impacts on the economy of the
interested regions.
Employment, sectoral competitiveness, trade and investment flows
With regard to impacts on particular sectors, despite the fact that cosmetic products are
exempted from CLP, the introduction of the ED hazard classes may create a conflict with the
CPR, as substances used as cosmetic ingredients only cannot resort to animal testing for
classification.
Regarding impacts on trade, the introduction of new hazard classes in CLP prior to their
introduction in the UN GHS could pose non-tariff barriers to trade for most sectors and for
companies within and outside the EU. GHS follows a “building block approach”, aiming at
ensuring a certain degree of flexibility with the hazard classes and categories to be implemented
while meeting the requirements regarding cut-off values, concentration limits and label
elements. RPA et al. (2017c) reported some key differences in:
The adoption of the building blocks;
The transition times for adoption of GHS and GHS biennial revisions;
The labelling and packaging requirements; and
The classification requirements across the countries or regions that have implemented GHS.
All these differences are constraints to the goal of global harmonisation and, effectively,
constitute non-tariff barriers to trade. Over 70% of the industry stakeholders participating to
the consultation activities carried out in the context of the RPA et al. (2017) study indicated
that differences in labelling requirements across countries are key drivers of costs.
There is a vast empirical literature in the environmental economics field investigating the
effects of asymmetric environmental regulations on key aspects of firms’ competitiveness,
including trade, industry location, employment, productivity, and innovation. The first major
review on the topic (Jaffe et al, 1995)158
concluded that ‘there is relatively little evidence to
158
Jaffe AB, Peterson SR, Portney PR, Stavins RN (1995): Environmental Regulation and the Competitiveness
of U.S. Manufacturing: What does the evidence tell us? Journal of Economic Literature, Vol. 33, No. 1
(Mar., 1995), 132-163.
228
support the hypothesis that environmental regulations have had a large adverse effect on
competitiveness, however that elusive term is defined’.
Thanks to the growing number of environmental policies worldwide and the availability of
high-quality data, their findings have been tested multiple times around the world. A review of
these studies by Dechezleprêtre and Sato (2017)159
found that the conclusion of Jaffe et al
(1995) ‘has only become more robust’. Moreover, ‘the cost burden of environmental policies
has often been found to be very small. The recent evidence shows that taking the lead in
implementing ambitious environmental policies can lead to small, statistically significant
adverse effects on trade, employment, plant location, and productivity in the short run,
particularly in pollution- and energy-intensive sectors. However, the scale of these impacts is
small compared with other determinants of trade and investment location choices such as
transport costs, proximity to demand, quality of local workers, availability of raw materials,
sunk capital costs, and agglomeration’.
These findings have also been confirmed by a study commissioned in 2014 by the European
Chemical Industry Council (Cefic) to investigate the prospects of the competitiveness of the
European chemical industry.160
Oxford Economics applied constant-market share analysis to
chemical exports coupled with econometric analysis. The authors found that the decrease in
extra-EU export market share observed in the preceding two decades is due to declining
competitiveness rather than slow-growing destination markets, in particular in the production
of petrochemicals and polymers. The change in competitiveness was found to be strongly
associated with energy prices, labour costs and research and development intensity. The
regulatory burden was not found to be an important driver (no strong statistical relationship).
Finally, the UN GHS has not yet been adopted fully by all countries, nor adopted in a
harmonised manner by those who have adopted it (for example, there is no implementation of
GHS for consumer products in North America). Therefore, significant differences in labelling
requirements continue to exist.
Social and environmental impacts
The ideal model
The benefits of including new hazard classes in CLP are expected to arise from the availability
of hazard information and the role that this plays in hazard communication, providing
incentives towards the use of safer alternatives and the reduction of exposure to hazardous
chemical products. The main benefits for human health and the environment will stem from a
reduction in exposures of people and the environment to ED, PBT/vPvB and PMT/vPvM
substances — and therefore avoidance of future cases of disease and environmental damage —
through risk management measures triggered under various pieces of downstream legislation
and, where applicable, under REACH. These will be delivered through:
Improved cohesion with other legislation, such as REACH, BPR and PPPR;
Improved communication of the hazards of substances and mixtures to downstream
users;
159
Dechezleprêtre and Sato (2017): The Impacts of Environmental Regulations on Competitiveness. Review of
Environmental Economics and Policy, volume 11, issue 2, Summer 2017, pp. 183–206.
160
Oxford Economics (2014): Evolution of competitiveness in the European chemical industry: historical trends
and future prospects. Report for Cefic – October 2014. Available at:
https://cefic.org/app/uploads/2019/02/OXFORD_ECONOMICS_competitiveness_chemind_2014.pdf
229
Incentives to shift to safer alternatives; and
For some mixtures, reformulation (leading to reductions in exposure and risk of workers and
consumers).
The ideal model — ignoring the availability of relevant data — to assess the benefits of the
introduction of new hazard classes requires:161
Policy effect on exposure. An assessment of the extent to which the CLP revision will reduce
human and environmental exposure to chemicals. Refer to this change as X where X refers
to exposure. In reality, X is a vector of many different chemicals. For those that are withdrawn
completely from the market as a result of the introduction of new hazard classes, X = 100%.
Exposure-response relationship. The effect on human health can be referred to as H, which
is a vector of many different health outcomes. Because there may be differences in the
monetary valuation, H can be distinguished in reduced occupational risks (HO) and reduced
public health risks (HP). The effect on the environment can be referred to as E. The overall
impact is therefore: I = HP + HO + E
Economic values. Monetary values are used to reconcile the different impacts. These shadow
prices162
(P) reflect individuals’ willingness to pay for avoiding the ill-health or negative
environmental impact associated with chemicals.
Time and discount factor. Because individuals have time preferences, changes in the future
are valued less than near-term changes. To compare monetary values in the future with present
values (PV), a discount factor (DF) of 3% is used.163
Timing is important because the costs of
classifying, labelling and possibly substituting/withdrawing chemical products are entailed
before the point in time when exposure is reduced, and negative health outcomes are avoided.
Location. Human health and environment impacts are location-specific (e.g. the benefits of
risk reduction are higher in heavily populated areas). For convenience, the geographical
variation in exposure reduction is ignored and EU averaged values are used instead.
The present value of the benefits of the revision of CLP is:
PV (B) =  i, j, t I I, t (X j, t) x DF
Where i: different health and environmental outcomes and j: different chemical products
The CLP revision would pass the cost-benefit test if the PV (B) > PV (C).
The problem with the ideal model is that the following parameters are not known:
The effects of the CLP revision on exposure (X), since this is dependent on the behavioural
reaction of producers, users, and regulators to changes in the classification and labelling of
chemical products.
161
Adapted from Pierce and Koundouri (2003): The social cost of chemicals. The Cost and Benefits of Future
Chemicals Policy in the European Union. A WWF Chemicals and Health campaign report.
162
Prices that would be attached to the reduced risk if there was an overt market in risk reduction.
163
As recommended by the Better Regulation guidelines.
230
The health and environmental exposure-response functions (I(X)) for the chemical
products that may be classified for the new hazard classes, the split between occupational and
public health effects and when the reduction of exposure may be realised.
Because of the limitations in the availability of data, another method needs to be devised, which
is determining a benchmark, i.e. how large the benefits need to be for the CLP revision to
pass a cost-benefit test. This procedure requires a range of assumptions, detailed in the
following subsections.
The approach to quantifying and monetising the benefits involves:
Estimating how many substances are identified as having ED, PBT/vPvB and
PMT/vPvM properties;
Identifying the disorders, diseases and impacts that are associated with each of those
hazardous properties;
Applying appropriate economic metrics for the single cases avoided or units of
environmental area improved for each type of hazardous properties (in €s); and
Estimating the number of cases of these diseases, disorders and impacts that would have to be
reduced in order for the benefits of each information option to outweigh the costs.
A range of disorders, diseases and impacts can be associated with each of the hazardous
properties to which can be applied appropriate economic metrics to provide a monetary value
for the associated damages. Valuing damages in this way provides a means of estimating the
benefits of each option in terms of the damage costs avoided through identification of
hazardous properties and appropriate risk management. At the same time, the range of possible
outcomes from exposure and environmental releases is much larger than the range of available
metrics. As such, valuation must rely on selected ‘representative’ outcomes.
Estimating the magnitude of such benefits and a complete monetary valuation is confounded
by a number of problems, including the possibility of estimating the attributable fraction of
disease incidence, prevalence and mortality to certain chemical products. There is a lack of
detailed health statistics and monitoring data, and the long latency period — measured in
years/decades — of some health outcomes between exposure to a causative agent — such as
an ED — and diagnosis of disease is an additional complicating factor, with the effect that the
benefits of any reduction in exposure achieved via CLP and other chemicals regulation will not
be manifested until some point in the future. For the environmental component, very few
metrics are available, and this limits the ability of the analysis to assess the full breadth and
depth of possible impacts. Thus, by default, assessment of the benefits will tend to
underestimate the ‘true’ environmental benefit.
A break-even approach is adopted to weigh up the likely relative advantages and drawbacks of
option 1a and judge whether it is likely to be ‘justified’ considering the costs. The aim is to
answer the following questions:
 What level of benefit would be required to offset the costs?
 What is the minimum number of cases/outcomes that would need to be avoided to
achieve this level of benefit?
 Is this minimum number cases/outcomes avoided a plausible outcome of the option?
In order to estimate the economic value of the potential human health damage costs avoided, a
cost-of-illness approach has been adopted. This considers medical treatment costs,
231
productivity/earnings losses and, where available, individual’s willingness to pay (WTP) to
avoid the outcome under consideration.
The following subsections provide an overview of the possible health and environmental
outcomes of the exposure to substances with ED, PBT/vPvB and PMT/vPvM properties, and
their economic metrics.
Endocrine disruptors
Despite all uncertainties and information gaps, researchers agree that exposure to EDs may
lead to substantial societal costs, with estimates in the range of billions of euros for the EU on
a yearly basis, with some studies estimating costs in the range of €46-288 billion per year (Rijk
et al, 2016).164
Assuming that the overall burden is broadly correct, the grand total cost of PO1
is approximately one to three thousandths of the overall burden. However, there is a lot of
uncertainty associated with the causal link between health effects and EDs’ exposure and the
corresponding health-related costs. Moreover, only a few ED-associated health effects have
been quantified, and therefore any estimate need to be interpreted with care.
Due to the large uncertainties surrounding the monetary evaluation of the health and
environmental impacts of EDs, a break-even approach is used to provide an illustration of the
number of specific health outcomes that policy option 1 would have to contribute to avoid
justifying its costs. This is complemented by an additional benchmark approach, comparing
the benefits calculated through predefined population attributable fractions to the costs of the
policy option.
Human and environmental exposure to EDs — through multiple routes — is the result of their
presence in a wide variety of products, including food packaging, pharmaceuticals, cosmetics
and personal care products, pesticides, fabrics and upholstery, electronics, plastic bottles, metal
food cans, detergents and toys (Kassotis et al., 2020). EDs can mimic or interfere with the
body’s endocrine system, and associated effects include impacts on male and female
reproduction, breast development and cancer, prostate cancer, neuroendocrinology, thyroid,
metabolism and obesity, and cardiovascular endocrinology.165
Vulnerable groups, such as
young children, are particularly affected by exposure to EDs, which can have life-long impacts
and exhibit in adulthood. Rijk et al. (2016) identified more than 80 different health endpoints
which have been potentially associated to exposure to EDs. Table 65 reproduces health
outcomes attributable to exposure to specific EDs — with strength of human evidence and
probability of causation — as reported by Kahn et al. (2020).
Table 66: Strength of evidence and probability of causation for outcome-exposure associations
Outcome Strength of human evidence Probability of causation
Perinatal outcomes
Low birthweight Not assessed Not assessed
Preterm birth Not assessed Not assessed
Reduced anogenital distance Not assessed Not assessed
Neurodevelopmental
IQ loss and intellectual disability Moderate to high 70-100%
164
I. Rijk, M. van Duursen, and M. van den Berg, Health cost that may be associated with Endocrine Disrupting
Chemicals — An inventory, evaluation and way forward to assess the potential health impact of EDC-associated
health effects in the EU, Institute for Risk Assessment Sciences, University of Utrecht, 2016.
165
National Institute of Environmental Health Sciences. (n.d.) Endocrine Disruptors.
https://www.niehs.nih.gov/health/topics/agents/endocrine/index.cfm
232
Table 66: Strength of evidence and probability of causation for outcome-exposure associations
Outcome Strength of human evidence Probability of causation
Attention-deficit disorder Low to moderate 20-69%
Autism spectrum disorder Low 20-39%
Metabolic
Childhood obesity Moderate 40-69%
Adult obesity Low 40-69%
Adult diabetes Low 40-69%
Reproductive outcomes
Cryptorchidism Low 40-69%
Low testosterone, resulting in
increased early mortality
Low 40-69%
Male infertility, resulting in
increased use of assisted
reproductive technology
Low 40-69%
Endometriosis Low 20-39%
Fibroids Low 20-39%
Testicular cancer Very low to low 0-19%
Semen quality Not assessed Not assessed
Polycystic ovarian syndrome Not assessed Not assessed
Breast cancer Not assessed Not assessed
Notes: Kahn et al. (2020) report strength of evidence and probability of causation per specific EDs and time of exposure
(prenatal, pregnancy, adult, lifetime). This table reproduces only the highest strength of human evidence and probability
of causation among specific EDs and time of exposure.
Kahn et al. (2020) is part of a series of papers published by Trasande and colleagues starting
in 2015166
estimating the socioeconomic impacts of health outcomes attributable to EDs’
exposure. These papers use the population attributable fraction methodology and calculate the
attributable costs as the product of disease rate, attributable fraction, population size and cost
per case. The cost per case includes health care direct costs, rehabilitation costs and lost
productivity. To establish the probability of causation, the authors adapted the
Intergovernmental Panel on Climate Change (IPCC) approach, combining the assessment of
the strength of the epidemiological and toxicological evidence. Bond and Dietrich (2017) have
criticised the methodology used in this series of papers, pointing to a number of criticalities:
skewed and non-transparent selection of experts for the panels establishing probability
causation for each outcome-exposure association; limited evidence for certain outcome-
exposure association; non-transparent selection of the literature evaluated; monetisation of
health outcomes with low to moderate probability of causation; insufficient number of experts
in the panels. It should be noted that Trasande and colleagues have responded to the
criticisms,167,168
defending their methodology and maintaining that the economic estimates are
likely to be conservative.
For the purpose of this assessment, a subset of four health outcomes was selected — one
outcome for each outcome category:
166
Trasande et al. (2015); Bellanger et al. (2015); Hauser et al. (2015); Legler et al. (2015); Hunt et al. (2016);
Trasande et al. (2016)
167
Hunt et al. (2016): Response to the Letter by G. M. H. Swaen and R. Otter. The Journal of Clinical
Endocrinology & Metabolism, Volume 101, Issue 11, 1 November 2016, Pages L110–
L111, https://doi.org/10.1210/jc.2016-3294
168
Bellanger et al. (2015): Response to the Letter by Middlebeek and Veuger. The Journal of Clinical
Endocrinology & Metabolism, Volume 100, Issue 6, 1 June 2015, Pages L54–
L55, https://doi.org/10.1210/jc.2015-2221
233
Low birth weight (perinatal outcomes);
IQ loss and intellectual disability (neurodevelopmental);
Childhood obesity (metabolic);
Male infertility (reproductive outcomes).
A very low weight at birth can have consequences on development, including an increased
prevalence of neurosensory problems, behavioural and social competence problems, and
intellectual and learning disabilities. As noted in ECHA (2016c), the actual outcomes
associated to very low birth weight cannot be known in advance. Alberini and Ščasný (2014)
value that the prevention of one case of very low birth weight at €2012405,000 (equal to
€2021450,000)169
from a public perspective.
Neurodevelopmental disabilities have been associated with IQ productivity losses and other
associated health and societal costs. A number of authors170 171 172
have estimated the cost of
an IQ point lost as USD201019,269 (equal to EUR202130,500) in discounted lifetime costs.
Honeycutt et al. (2004) report average lifetime costs per case of intellectual disability of
USD20031,014,000 (equal to €20211,690,000).173
Obesity presents significant healthcare costs to society and can result in various related
conditions and subsequent reductions in life expectancy. Direct costs considered include drugs,
hospitalisations, monitoring and obesity-associated pathologies. Indirect costs are productivity
losses, in terms of both presenteeism and absenteeism.174
Hamilton and Dee (2017) value the
total lifetime excess cost per obese child as €2021160,000.175
There are significant individual and societal costs associated with male reproductive health
problems, with costs including medical and fertility treatment. Alberini and Ščasný (2014)
estimated the value of a statistical pregnancy among the general population in €201237,900
(equal to €202142,000).
With regard to the environmental impacts of EDs’ exposure, while there is strong evidence in
specific cases (endocrine disruption in fish), there is limited understanding of the causal
associations between EDs and effects on individual animals and wider wildlife populations
(Jobling, S., Tyler, C. R., 2006).
Illustrative benefit calculations – EDs
Number of cases to be avoided to justify the costs
169
Rounded to the nearest ten thousand.
170
Attina TM, Trasande L (2013): Economic costs of childhood lead exposure in low and middle-income
countries. Environ Health Perspect 121:1097-1102
171
Trasande L, Liu Y (2011): Reducing the Staggering Costs of Environmental Disease in Children, Estimated at
$76.6 Billion In 2008. Health Affairs 30:863-870
172
Bellanger et al. (2013): Economic benefits of methylmercury exposure control in Europe: monetary value of
neurotoxicity prevention Environmental Health 12
173
Converted using the purchasing power parities and inflation rates reported by the OECD
(https://data.oecd.org/conversion/purchasing-power-parities-ppp.htm) and
(https://stats.oecd.org/index.aspx?queryid=82174)
174
Presenteeism refers to the lost productivity that occurs when employees are not fully functioning in the
workplace because of an illness, injury, or other condition. Absenteeism occurs when people are sick, injured,
unwell or are unable to come to work due to circumstances.
175
Rounded to the nearest ten thousand.
234
The benefits of PO1 are equal to the number of adverse human health and environmental
outcomes avoided multiplied by the cost (or value) of each of those outcomes. Regarding the
value of the outcomes avoided, the range of possible outcomes from human exposure and
environmental releases to EDs is much larger than the range of available metrics. The valuation
of the benefits relies on selected ‘representative’ outcomes which capture some of the possible
outcomes. Thus, by default, any assessment of the benefits will tend to underestimate the ‘true’
benefit. There is no means of predicting how many avoided cases PO1 would result in, and
therefore there is no ‘case multiplier’ to calculate the benefits.
In order to simplify the analysis, the values of the multiple possible outcomes of EDs’ exposure
have been aggregated to provide a single statistical value, using a weighted average approach
based on assumed equal frequency of outcomes (Table 66). The weighted average value has
been annualised using a 40-year period to account for the long latency of the considered health
outcomes — i.e. the long time that passes between being exposed and having symptoms — and
for the fact that some of the health outcomes affect the offspring of the exposed population.
Table 67: Aggregation of values for substances with outcomes
Substance
properties
Valuation metric Monetary value Relative frequency /
weight
Weighted average
value to be applied
Endocrine
disruption
Low birth weight €450,000 25% €585,500
PV = € 25,330 (40y,
3%)
Intellectual disability €1,690,000 25%
Childhood obesity €160,000 25%
Male infertility €42,000 25%
The minimum number of cases/outcomes that would need to be avoided to offset PO1a costs
for ED substances is estimated to range between 1,325 – 2,981 in the case of 9% of the
substances classified for ED properties being withdrawn from the market because of CLP
classification. This equates to 0.6 to 1.4 cases/outcomes to be avoided per substance (Table
67).
Table 68: Illustrative benefits for ED substances
PV total cost of PO1a for ED substances - (9% market withdrawal) €33,560,000 - €75,510,000
(CI: €27M - €95M)
PV total cost of PO1a for ED substances - (25% market withdrawal) €72,000,000 - €162,880,000
(CI: €59M - €205M)
Statistical case
PV (40 years; 3%) of weighted average value of statistical outcome €25,330
Total number of cases to be avoided to justify PO1a costs for EDs - (9% market
withdrawal)
1,325 – 2,981
(CI: 1,095 – 3,759)
Total number of cases to be avoided to justify PO1a costs for EDs - (25% market
withdrawal)
2,843 – 6,430
(CI: 2,348 – 8,109)
Number of cases to be avoided per substance - (9% market withdrawal) 0.62 – 1.39
Number of cases to be avoided per substance - (25% market withdrawal) 4.97 – 11.24
Low birth weight
PV (40 years; 3%) of weighted average value of statistical outcome €19,468
Total number of cases to be avoided to justify PO1a costs for EDs - (9% market
withdrawal)
1,724 – 3,879
(CI: 1,424 – 4,891)
Total number of cases to be avoided to justify PO1a costs for EDs - (25% market
withdrawal)
3,699 – 8,366
(CI: 3,055 – 10,551)
Number of cases to be avoided per substance - (9% market withdrawal) 0.8 – 1.81
Number of cases to be avoided per substance - (25% market withdrawal) 6.47 – 14.63
Intellectual disabilities
PV (40 years; 3%) of weighted average value of statistical outcome €73,113
235
Total number of cases to be avoided to justify PO1a costs for EDs - (9% market
withdrawal)
459 – 1,033
(CI: 379 – 1,302)
Total number of cases to be avoided to justify PO1a costs for EDs - (25% market
withdrawal)
958 – 2,228
(CI: 814 – 2,809)
Number of cases to be avoided per substance - (9% market withdrawal) 0.21 – 0.48
Number of cases to be avoided per substance - (25% market withdrawal) 1.72 – 3.89
Childhood obesity
PV (40 years; 3%) of weighted average value of statistical outcome €6,922
Total number of cases to be avoided to justify PO1a costs for EDs - (9% market
withdrawal)
4,849 – 10,909
(CI: 4,006 – 13,757)
Total number of cases to be avoided to justify PO1a costs for EDs - (25% market
withdrawal)
10,402 – 23,530
(CI: 8,593 – 29,674)
Number of cases to be avoided per substance - (9% market withdrawal) 2.26 – 5.09
Number of cases to be avoided per substance - (25% market withdrawal) 18.19 – 41.14
Male infertility
PV (40 years; 3%) of weighted average value of statistical outcome €1,817
Total number of cases to be avoided to justify PO1a costs for EDs - (9% market
withdrawal)
18,471 – 41,558
(CI: 15,259 – 52,407)
Total number of cases to be avoided to justify PO1a costs for EDs - (25% market
withdrawal)
39,628 – 89,640
(CI: 32,737 – 113,042)
Number of cases to be avoided per substance - (9% market withdrawal) 8.61 – 19.37
Number of cases to be avoided per substance - (25% market withdrawal) 69.28 – 156.71
Table 67 also provides the total number of cases and the number of cases per substance to be
avoided to justify the costs of PO1a considering each one of the four health outcomes that have
been associated with exposure to EDs. This allows to compare the total number of cases to be
avoided with the prevalence of each one of the health outcomes:
Low birth weight: in the EU in 2018, 1 in 15 babies (6.6%) weighed less than 2,500 grammes
at birth.176
There were 4,245,710 live births in the EU27,177
meaning that around 280,217
babies had a low birth weight according to the WHO definition. The total number of low birth
weight cases to be avoided to justify PO1a costs ranges from 1,724 to 8,366 (central estimate),
i.e. between 0.6% and 3% of the number of low birth weight cases in 2018.
Intellectual disabilities: McKenzie et al. (2016) report the prevalence of intellectual
disabilities at one percent.178
Considering an average of 4 million live births per year,179
around
40,000 babies with intellectual disabilities are born every year. The total number of intellectual
disabilities cases to be avoided to justify PO1a costs ranges from 459 to 2,228 (central
estimate), i.e. between 1.1% and 5.6% of the number of low birth weight cases every year.
176
OECD/European Union (2020): Health at a Glance: Europe 2020: State of Health in the EU Cycle, OECD
Publishing, Paris, https://doi.org/10.1787/82129230-en (Figure 3.15)
177
Eurostat: All data > Population and social conditions > Demography, population stock and balance >
Fertility (national level) > Live births (total) by month (DEMO_FMONTH)
178
McKenzie, K., Milton, M., Smith, G. et al. (2016): Systematic Review of the Prevalence and Incidence of
Intellectual Disabilities: Current Trends and Issues. Curr Dev Disord Rep 3, 104–115.
https://doi.org/10.1007/s40474-016-0085-7
179
Eurostat: All data > Population and social conditions > Demography, population stock and balance >
Fertility (national level) > Live births (total) by month (DEMO_FMONTH)
236
Childhood obesity: ‘Nearly one in eight children (12%) aged 7-8 is obese on average in EU
countries’.180
There are around 4,500,000 eight years old each and every year,181
meaning that
around 540,000 eight years old children are obese in the EU each and every year. The total
number of childhood obesity cases to be avoided to justify PO1a costs ranges from 4,849 to
23,530 (central estimate), i.e. between 0.9% and 4.4% of the number of childhood obesity cases
every year.
Male infertility: According to Agarwal et al. (2015),182
the prevalence of male infertility in
Europe is around 7.5% of the male population. In 2020, there were 2,089,615 male live births
in the EU27.183
This means that, by applying the prevalence rate, there were 156,721 man born
with reduced semen quality resulting in infertility. The fertility ratio in the EU27 is 1.50461,
so the number of children that will not be born naturally due to reduced semen quality is
235,804. The total number of male infertility cases to be avoided to justify PO1a costs ranges
from 18,471 to 89,640 (central estimate), i.e. between 7.8% and 38% of the number of male
infertility cases every year.
Predefined population attributable fractions
While the evidence between exposure to endocrine disruptors and negative health outcomes is
convicing (although varying in strength), the estimate of the population attributable fractions
is associated with large uncertainties, due to their multifactorial nature. WHO/UNEP (2012)184
attributes 24% of human diseases and disorders globally to environmental factors. Prüss-Ustün,
et al. (2016) suggest that around 22% of GBD could be attributed to environmental risks using
a range of methods of expert elicitation. How much of this proportion could be attributed to
chemicals’ exposure — or EDs’ exposure — is unclear and subject to intense research. As
illustrative example, Olsson et al. (2014)185
used three different ‘etiological fractions’: 1%
(low), 20% (medium) and 40% (high), recognising that other environmental factors play a role
(e.g. dietary factors, body mass index and waist circumference, obesity, smoking, degree of
physical activity and alcohol consumption). Rijk et al. (2016) used 1%, 2.5% and 10%,
considering that the first two point estimates are within the lower ranges of fractions
attributable to environmental factors — and more specifically to chemicals — presented in
WHO and OECD papers. The 10% point estimate is used as high end of the range, which is
still conservative if compared to the range used by Olsson et al. (2014). Indeed, Rijk et al.
(2016) recognise that ‘for some diseases the role of environmental factors in stronger than for
other diseases’.
180
OECD/European Union (2018): Health at a Glance: Europe 2018: State of Health in the EU Cycle, OECD
Publishing, Paris/European Union, Brussels, https://doi.org/10.1787/health_glance_eur-2018-en (Figure 4.15).
181
Eurostat: All data > Population and social conditions > Demography, population stock and balance >
Population (national level)
182
Agarwal, A., Mulgund, A., Hamada, A., & Chyatte, M. R. (2015): A unique view on male infertility around
the globe. Reproductive biology and endocrinology : RB&E, 13, 37. https://doi.org/10.1186/s12958-015-0032-1
183
Eurostat: All data > Population and social conditions > Demography, population stock and balance >
Fertility (national level) > Live births by mother's age and newborn's sex (DEMO_FASEC)
184
WHO/UNEP (2012) State of the science of endocrine disrupting chemicals 2012. Edited by Åke Bergman,
Jerrold J. Heindel, Susan Jobling, Karen A. Kidd and R. Thomas Zoeller.
185
Olsson et al. (2014): The Cost of Inaction. A socioeconomic analysis of costs linked to effects of endocrine
disrupting substances on male reproductive health. TemaNord 2014:557. Nordic Council of Ministers.
237
Under this approach, the costs attributable to exposure to EDs are taken as a proxy of the
benefits. Table 69 (overleaf) presents the discounted costs (40-year period; 3%) per year of
cases attributable to exposure to EDs for four health outcomes. Using a predefined population
attributable fraction of 2.5%, the total costs per year amount to over €300 million. The one-off
cost estimates of policy option 1a for EDs range between €33 million and €163 million, or
around 10% to 50% of the costs of cases of ill-health attributable to EDs’ exposure per year.
How much of these costs will be saved by the CLP revision only is unknown, but the
introduction of identification and classification criteria for EDs in CLP is the prerequisite for
the delivery of all benefits, including through the extension of the generic approach to risk
management (foreseen in the revision of REACH) and, more in general, through the
enhancement of risk management measures to minimise exposure. Moreover, considering that
over 80 health endpoints have been associated to exposure to EDs and that the estimates
presented refer to a subset of only four health outcomes, hence an underestimation, the omitted
benefits are very likely to result in the total benefits being much greater than the costs of this
policy option. Environmental impacts have also not been accounted for, although an attempt
for PBT/vPvB and PMT/vPvM substances is presented in the following subsection.
238
Table 69: Discounted costs per year of cases attributable to EDs’ exposure for four health outcomes
Health
outcome
Lifetime
cost per case
Discounting
period
Discount
rate
Discounted
lifetime cost
per case Prevalence Population Cases PAF
Cases attributable
to EDs per year
Cost per year
Low birth
weight
€450,000
40 3
€
19,468.07 6.60% 4,245,710 280,217 2.5% 7,005 € 136,382,036
Intellectual
disabilities
€1,690,000
40 3
€
73,113.42 1% 4,000,000 40,000 2.5% 1,000 € 73,113,419
Childhood
obesity
€160,000
40 3
€
6,921.98 12% 4,500,000 540,000 2.5% 13,500 € 93,446,736
Male
infertility
€42,000
40 3
€
1,817.02 7.50% 2,089,615 235,804 2.5% 5,895 € 10,711,522
Total € 313,653,713
239
Illustrative benefit calculations - PBT/vPvB and PMT/vPvM substances
A core methodological difficulty for estimating (and valuing) the benefits of action to curb or
cease emissions of PBT/vPvB (or otherwise address risks) is that ‘safe’ concentrations of
PBT/vPvB and PMT/vPvM substances in the environment cannot be established with
reliability. Target compartments and species at risk cannot be identified with sufficient levels
of accuracy and, owing to the long-term presence of these substances in the environment,
secondary poisoning and multi-generational effects in wildlife cannot be readily predicted.
The inability to estimate the monetary benefits of actions to curb emissions from PBT/vPvB is
evidenced by the lack of benefit estimations in the EU REACH restriction dossiers for
PBT/vPvB regulated thus far under EU REACH. Few stated preference-based studies have
been undertaken with the aim of developing monetary estimates of people’s WTP to adopt a
precautionary approach with respect to PBT and vPvB. As noted by ECHA (2014), the lack of
information on changes in impacts makes it difficult to develop credible change scenarios
which could leave survey respondents unclear as to what they are being asked to value.
The most relevant ‘off the shelf’ estimates are those associated with restrictions brought into
force under EU REACH, expressed as costs per kg/tonne of emissions reduced/to be reduced.
These are reported in ECHA’s (2021) report on the “Costs and benefits of REACH restrictions
proposed between 2016 to 2020”186
but are often simply costs of switching to alternatives.
Rarely, restriction dossiers have costs of clean-up in different countries (e.g. Australia with
PFAS). None of the available information, then, explicitly values the impacts.
For these reasons, a break-even approach is used to provide an illustration of the quantity of
PBT/vPvB and PMT/vPvM substances substituted/withdrawn from the market that policy
option 1 would have to contribute to justifying its costs.
The illustrative benefits of the inclusion of PBT/vPvB and PMT/vPvM hazard classes in CLP
were calculated assuming that the quantity of PBT/vPvB or PMT/vPvM substances substituted
or withdrawn from the market due to CLP classification is equal to 345 tonnes on average per
substance. This weighted average was calculated by multiplying the tonnage band distribution
shares of basket 1 and basket 2 PBT/vPvB and PMT/vPvM substances multiplied for the lower
end of the tonnage bands:
31% of the substances that could be classified for PBT/vPvB or PMT/vPvM properties
are currently registered in quantities above 1,000 tonnes per year. This share has been
multiplied for 1,000 tonnes;
36% of the substances are registered in quantities above 100 tonnes per year. This share
has been multiplied for 100 tonnes;
21% of the substances are registered in quantities above 10 tonnes per year. This share
has been multiplied for 10 tonnes;
12% of the substances are registered in quantities above 1 tonne per year. This share has been
multiplied for 1 tonne.
The estimate of 345 tonnes per year as the statistical average quantity of each PBT/vPvB and
PMT/vPvM substance on the market is very conservative, as it assumes that all substances are
186
ECHA Costs and benefits of REACH restrictions proposed between 2016-2020 February 2021, available at:
https://echa.europa.eu/documents/10162/13630/costs_benefits_reach_restrictions_2020_en.pdf/a96dafc1-42bc-
cb8c-8960-60af21808e2e
240
manufactured or imported at the lowest end of the REACH registration tonnage band and does
not account for multiple registrants per substance. The present value of the total cost of
including hazard classes for PBT/vPvB and PMT/vPvM properties ranges from €5M to €27M
(depending on the assumption on the number of mixtures containing one substance), which
equate to €0.2-0.74 per kg of PBT/vPvB or PMT/vPvM substances. If the benefits of
withdrawing PBT/vPvB and PMT/vPvM substances are €0.7 or above, then PO1 would be
justified.
Table 70: Illustrative benefits for PBT/vPvB and PMT/vPvM substances (per year)
Statistical average quantity of each PBT/vPvB and PMT/vPvM
substance on the market
345,000 kg
Number of substances withdrawn from the market due to CLP
classification – (9% of all classified PBT/vPvB and PMT/vPvM
substances)
56
Number of substances withdrawn from the market due to CLP
classification – (25% of all classified PBT/vPvB and PMT/vPvM
substances)
156
Total kg PBT/vPvB and PMT/vPvM withdrawn – 9% 19,468,350 kg
Total kg PBT/vPvB and PMT/vPvM withdrawn – 25% 54,078,750 kg
PV total cost of PO1a for PBT/vPvB and PMT/vPvM substances €5,870,000 - €12,200,000 (based on
11 mixtures per substance)
€13,140,000 - €27,520,000 (based
on 25 mixtures per substance)
Benefits per kg PBT/vPvB or PMT/vPvM to offset PO1a costs Minimum €0.2 – 0.7
As noted by SEAC, “data on P, B and T properties does not often allow for quantitative
assessment of the human health or environmental impacts. The valuation of benefits via the
assessment of the impacts on the environment and human health – the standard ‘impact
pathways’ approach to benefits assessment for chemicals – is therefore not possible, and other
options for benefits assessment need to be considered”.187
Accordingly, SEAC has pursued the
approach of establishing a benchmark for the proportionality/disproportionality of action to
reduce emissions of PBTs considering the cost of past action. Oosterhuis and Brouwer (2015)
gathered information on the costs of PBT emission reduction or reductions in the use or
exposure to PBT/vPvB substances. In addition, they applied a ‘revealed preferences’ approach
to value the public willingness to pay for such reduction. The authors found that the maximum
willingness to pay is difficult to determine, but the ‘largest minimum’ willingness to pay
implied by spent or budgeted investment on PFOS removal is at least €35,000 per kg.
Considering potential further investment, this minimum value might increase to between
€200,000 and €300,000 per kg. The study identifies values ranging from €1,000 to €50,000 per
kg PBT substituted, remediated or emission reduced. The proportionality of these costs
depends on the damage potential of the PBT/vPvB substances, which in turn depends on their
environmental fate/distribution, characteristics, size and dynamics of the stocks and flows in
the environment, the exposure ad hazard potential. Oosterhuis and Brouwer (2015) stress that
cost estimates for clean-up / remediation are much higher than cost estimates for substitution,
with the values ranging from less than one euro to several millions of euros per kilogramme.
Cost estimates for substitution depend on the availability and production costs of suitable
alternatives and are specific to the end uses of the substance to be substituted. Moreover, costs
187
Evaluation of restriction reports and applications for authorisation for PBT and vPvB substances in SEAC.
SEAC/31/2016/05 Rev.1 (Agreed at SEAC 31). Helsinki, 9 June 2016.
241
per kilogrammes vary hugely depending on the total amount or concentration of the PBT/vPvB
substance and whether it is contained in a closed/confined space or widely dispersed.
Nevertheless, comparing the ‘grey zone’ of proportionality with the cost of €0.2-0.7 per kg of
PBT/vPvB or PMT/vPvM substance substituted suggests that the classification of PBT/vPvB
and PMT/vPvM substances through CLP is likely to justify the total costs.
RPA & ARCHE (2019)188
report several examples of costs of remediating sites where
contamination of groundwater and soil has occurred due to past use of PFAS: Weber (2016)189
reports costs of upgrading wastewater treatment works to reduce PFAS concentration in
drinking water in the Ruhr and its tributaries of around €100 million, with the works taking
several years. The costs of remediating the contamination of Dusseldorf airport due to the use
of fire-fighting foams containing PFAS during fire-fighting practices were estimated at €100
million, and the cost of exchanging soil for a different site estimated between €1 billion to €3
billion. Remediation costs for two other PFAS-contaminated airports in Norway were reported
at €5.1 million (Evenes airport) and €3.1 million (Oslo Gardermoen airport) (Alling et al.
(2017).190
188
RPA & ARCHE (2019): Socio-Economic Assessment of PFHxS and PFHxS-related substances. Final report
for the Norwegian Environment Agency.
189
Weber R (2016): Some lessons learned from PFOS/PFAS management in Germany, Sciene and Policy of
Organohalogens pre-Dioxin Symposium, 28 August 2016, Firenze, Italy.
190
Alling, Vanja, Hartnik, Thomas, & Bjærtnes, Olaug (2017). Two case studies for remediation of PFAS
contaminated fire-fighting sites in Norway. Proceedings of the 7th International Contaminated Site Remediation
Conference, (p. 633). Australia.
242
Annex 9 – Harmonised Reference values
CONTEXT
The REFIT evaluation of REACH and Fitness Check of other chemical legislation identified
several issues/shortcomings that are related to the components of ‘one substance – one
assessment process’ and that affect proper functioning of the chemical legislation as regards its
effectiveness, efficiency or coherence. Addressing these shortcomings together with the
experience gained by the Commission and Agencies’ staff through past and on-going
assessments, while taking into account already on-going activities to improve the assessment
processes, will pave the way towards one substance – one assessment process.
As indicated in the chemical strategy for sustainability “The ‘one substance, one assessment’
approach aims to ensure that methodologies are made more coherent and to the extent possible
harmonised” and to “promote reuse and harmonisation of human and environmental health-
based limit values among EU risk assessors and managers through a centralised and curated
EU repository;”.
To this extent, the Commission will ensure that the CLP Regulation strengthens its role as the
cornerstone for hazard classification. To reach this aim, the Commission will introduce new
hazard criteria, for Endocrine Disruptors, PBTs/vPvBs and other potential SVHCs (e.g., PMT,
vPvM). In addition, in order to ensure that regulatory hazard characterization methodologies
are applied in a coherent and, to the extent possible, harmonised way, the Commission proposes
to add a procedure under CLP to derive and publish harmonised human and environmental
toxicological reference values.
The overall goal in harmonising human and environmental toxicological reference values in
CLP is to offer a unique reference value that could be used by downstream legislation, when
deemed appropriate. These values should support EU risk assessors and duty holders in their
specific regulatory framework. This is intended to be particularly relevant for the SDG #3 Good
health and well-being – Target 3.9 ‘By 2030, substantially reduce the number of deaths and
illnesses from hazardous chemicals and air, water and soil pollution and contamination’.
PROBLEMS AND DRIVERS
Problems
The risks to the human health and the environment deriving from the exposure to hazardous
chemicals are identified and addressed through the assessment procedures set out in the
legislation. The main steps of the chemical risk assessment and management process (Figure
66) involve different European agencies and expert committees.
243
Figure 66: Main steps of the chemical risk assessment and management process – Source: EC (2019e)
When considering the chemical risk assessment and management process, CLP provides only
for the first step: hazard identification and classification. Hazard characterization (or dose-
response assessment) involves the setting of human and environmental reference values, which
expresses the concentration of a substance below which no adverse effects on human health or
the environment are expected in case of threshold-substances or the risks are considered
acceptable in case of non-threshold substances. There are toxicity reference values which are
derived exclusively based on scientific data and considerations, and values which take into
account also socio-economic, technical feasibility and other considerations. These include
regulatory limits on the concentration in specific products. Table 69 provides a non-exhaustive
list of reference values.
Table 70: Non-exhaustive list of toxicity reference values
Derived No-Effect Level (DNEL)
Derived Minimal Effect Level (DMEL)
Predicted No Effect Concentration (PNEC)
Environmental Quality Standard (EQS)
Acceptable or Tolerable Daily/Weekly Intake (ADI or TDI/TWI)
Tolerable Upper Intake Level (UL)
Acute Reference Dose (ARfD)
Acceptable Operator Exposure Level (AOEL)
Acute Acceptable Operator Exposure Level (AAOEL)
Occupational Exposure Limit (OEL)
Indicative Occupational Exposure Limit Value (IOELV)
Binding Occupational Exposure Limit Value (BOELV)
Maximum Residue Level (MRL)
Threshold of Toxicological Concern (TTC)
Maximum Tolerable Dose (MTD)
Average Requirement (AR)
Population Reference Intake (PRI)
Adequate intake (AI)
Maximum Tolerable Daily Intake (MTDI)
Acceptable Intake
Health based exposure limit (HBEL)
Permitted Daily Exposure (PDE)
Source: Call for tenders ENV/2021/OP/0019 - Designing EU repository of health-based limit values and collating
information for the first version of the repository
244
These are derived by companies, competent authorities, EU Commission or international
organisations under REACH or other pieces of legislation. Table 70 provides a non-exhaustive
list of legislation under which toxicity reference values are set.
Table 71: Non-exhaustive list of legislation under which HBLVs are set
REACH Regulation (EC) 1907/2006
Plant Protection Products Regulation (EC) 1107/2009
Biocidal Products Regulation (EU) 528/2012
Cosmetic Products Regulation (EC) 1223/2009
Food Contact Materials Regulation (EC) 1935/2004
Regulation on contaminants in food (EEC) 315/93
Directive on undesirable substances in animal feed (2002/32/EC)
Food improvement agents Regulation (EC) 1331/2008
Regulation on food additives (EC) 1333/2008
Regulation on food enzymes (EC) 1332/2008,
Regulation on flavourings (EC) 1334/2008
Regulation 234/2011 implementing Regulation (EC) No 1331/2008
Feed additives Regulation (EC) 1831/2003
Maximum Residue Levels of pesticides Regulation (EC) 396/2005
Water Framework Directive (2000/60/EC)
Environmental Quality Standards Directive (2008/105/EC)
Groundwater Directive (2006/118/EC)
Drinking Water Directive (EU) 2020/2184
Marine Strategy Framework Directive (2008/56/EC)
Carcinogens and Mutagens Directive (2004/37/EC)
Chemicals Agents Directive (98/24/EC)
Asbestos at Work Directive (2009/148/EC)
Regulation (EU) 37/2010 on pharmacologically active substances and their classification
regarding maximum residue limits in foodstuffs of animal origin
Source: Call for tenders ENV/2021/OP/0019 - Designing EU repository of health-based limit values and
collating information for the first version of the repository
Differences between DNELs for the same substance
With the ECHA Guidance on Information Requirements and Chemical Safety Assessment, R.8
(ECHA, 2012) a detailed methodological guidance for deriving DNELs is available.
Nevertheless, in a study on behalf of the Dutch RIVM, the authors found substantial differences
depending on the body deriving the DNELs (Schenk et al., 2014). Schenk et al. (2015) noticed
large differences in DNELs for 20 substances from registration dossiers, when comparing it to
Swedish OELs and to DNELs derived for these substances by the authors themselves, based
on the R.8 Guidance document. Differences up to several orders of magnitude were observed.
In many cases the authors observed differences in the dose descriptor used (i.e. differences in
selection of key study and leading effect).
A statistical approach has been used to further analyse the issue. The DNEL List of the German
Social Accident Insurance Association (DGUV)191
was downloaded that contains inhalation
DNELs for workers (long-term, local and systemic effects) as of November 2020. This list
191
GESTIS DNEL List, Hazardous substance information system of the German Social Accident Insurance,
available at: https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp
245
contains 6,611 entries relating to 5,804 unique chemicals. Of these 5,804 unique chemicals,
5,390 (93%) only have one entry in the DNEL list. In most cases, this entry relates to a DNEL
for system effects only, but there are cases for which only a DNEL for local effects is available
or a DNEL for local and systemic effects. Among the remaining 414 unique chemicals, the
majority has two entries (N=319, 77%) and 90% have between two and four entries (N=374).
Two or more entries may result e.g. from different toxicological summaries provided in
IUCLID by the lead registrant and members of a consortium or from different submissions.
They may still contain identical DNELs and only differ in other respects. If two entries for a
substance exist, up to four DNELs may exist (two for local and systemic effects in both entries),
but only a local DNEL may exist in one entry and a systemic DNEL in the other entry (which
is in fact the case for a substantial number of substances).
An evaluation done on unique chemicals with two (identical or different) workers long-term
inhalation DNELs for systemic effects has been performed for the impact assessment. This
covers most of the chemicals with more than one entry and the exclusion of DNELs for local
effects is acceptable.192
In total, 214 comparisons are available, i.e. 214 unique chemicals with
two workers long-term inhalation DNELs for systemic effects, for which the higher DNEL can
be compared with the lower DNEL. For 12 of these substances (5.6%), the two DNELs are
identical. This low number is not surprising, since there is no reason to provide diverging
toxicological summaries if the DNELs (and all other information) are identical. Large
differences of several orders of magnitude are observed in rare cases and the highest difference
between the higher and the lower DNEL is by a factor of almost 40,000.193
This very high value
has a large impact on the mean difference between the higher and lower DNEL, as shown in
the following table.
Table 72: Summary statistics for the comparison of the higher and the lower DNEL per substance
N 214
AM 204 (18)*
MEDIAN 3.0
GM 4.4
MIN 1.0
MAX 39,837
Higher and lower DNELs within
a factor of 2 80 (37%)**
a factor of 5 134 (63%)**
a factor of 10 166 (78%)**
Notes: * Value in brackets after exclusion of the maximum value. ** Percentages relate to the total dataset (N=214)
The data suggest that DNELs in REACH registration documents may differ substantially in a
few cases, but that they do not differ by more than one order of magnitude for more than three-
fourth (78%) of the cases for which two DNELs are available. As noted above, more than one
DNEL entry exists only for 7% of the substances on the DNEL list, indicating that the problem
192
Note that if a substance has four entries with two relating only to local DNELs and two to systemic DNELs,
the substance was included in the evaluation.
193
The two DNELs are 0.49 mg/m3
and 12.3 ng/m3, respectively, for ammonium 2-mercaptopropionate (EC no.
236-526-4). No reason for these diverging DNELs is apparent from the disseminated registration dossier. The
experimental data suggest that the higher DNEL is more adequate. Furthermore, there is only a single registrant,
and no specific compositions are identified that could explain the lower values. The lower DNEL therefore likely
represents an erroneous entry.
246
is limited to few substances overall. This evaluation has some limitations. For example, it is
based on the DNEL list provided by DGUV (as of November 2020) and may include some
outdated information. For example, individual cases were noted where one of the DNELs was
provided in the dossier by a registrant who in the meanwhile ceased manufacture. Furthermore,
this analysis was limited to substances with only two DNELs and other outcomes may be
obtained if all substances are included. Finally, substance-specific evaluations of the
differences could not be performed due to time constraints. There may be good reasons for
differences in DNELs, such as differences in the composition and/or impurity profile of a
substances. Therefore, the differences noted above do not necessarily indicate inconsistencies.
Apart from different DNELs in REACH registration dossiers, DNELs derived by registrants
may also differ from the ones established by RAC for use in applications for authorisation
under REACH. In the following table substances are listed, for which RAC recommended
DNELs for use in authorisation dossiers. The DNELs as derived in the respective registration
dossiers are listed for comparison. For some of the substances, large differences in the
numerical values are obvious.
Table 73: RAC reference DNELs194
and DNELs from registration dossiers for substances in Annex XIV
Substance EC No. CAS No. DNEL -
Workers -
inhalation
(mg/m3)*
DNEL - General
population - oral
(mg/kg bw/d)*
RAC Dossier
**
RAC Dossier
**
Trixylyl phosphate
(TXP)
246-
677-8
25155-
23-1
0.08 2.96 0.008 0.15
1-bromopropane 203-
445-0
106-94-
5
6.2 0.029**
*
0.32 -
Diglyme (bis(2-
methoxyethyl)ether
203-
924-4
111-96-
6
1.68 26.8 0.09 1.04
Benzyl butyl phthalate
(BBP)
201-
622-7
85-68-7 9.9 4.36 0.5 0.5
Dibutyl phthalate
(DBP)
201-
557-4
84-74-2 0.13 0.13 0.007 0.007
Bis(2-ethylhexyl)
phthalate (DEHP)
204-
211-0
117-81-
7
0.88 1.6 0.034 0.036
Notes: * DNELs relate to long-term exposure (see text for details). ** REACH Registration dossier. *** DMEL for
carcinogenic effects.
Differences between DNELs and OELs/IOELVs
The restriction under REACH of the aprotic solvent N,N-dimethylformamide195
to fix a
‘harmonised DNEL’ for workers (inhalation and dermal) that shall be used by registrants of
this substance in their chemical safety report in order to determine the relevant risk
management measures for worker protection. However, harmonisation in this context only
relates to the REACH Regulation and other reference values remain in place, such as the
IOELV established by Commission Directive 2009/161/EU of 17 December 2009 (15 mg/m3
as opposed to the ‘harmonised DNEL’ of 6 mg/m3
) that is also legally binding limit value
194
https://echa.europa.eu/de/applying-for-authorisation/evaluating-applications
195
See REACH restriction undefined (europa.eu)
247
established under OSH legislation in many EU member states. For companies, the different
reference or limit values are confusing and the ‘harmonised DNEL’ does not resolve the
differences between REACH-DNELs and OELs.) that is also legally binding limit value
established under OSH legislation in many EU member states.
A large body of work investigating differences between OELs and DNELs is available. As
larger assessment factors are suggested to be used for DNELs (see below), DNELs are expected
to be lower than OELs for the same substance. This was observed by Schenk and Johanson
using the ECHA R.8 Guidance for several substances and comparing the resulting DNELs with
existing OELs as derived by the former Committee on Occupational Exposure Limits (SCOEL)
(Schenk and Johanson, 2011). For the example of styrene, Kreider and Spencer Williams
(2010) also concluded that the worker long-term DNEL according to the REACH Guidance
would be lower than OELs. However, when authors compared national OELs with existing
DNELs from registration dossiers no such differences were found. Partly, existing OELs were
used instead of deriving own DNELs (Nies et al., 2013; Schenk et al., 2015; Schenk et al.,
2014; Tynkkynen et al., 2015).
These analyses are primarily based on comparisons of DNELs with national OELs (from
Sweden, Finland and Germany). Therefore, additional analyses were performed by comparing
long-term DNELs from REACH registration dossiers (taken from the DGUV list mentioned
above) with EU IOELVs. After data curation, 103 substances remained in the analysis. The
following table summarises the results of this evaluation and shows similar comparisons of
DNELs and IOELVs in two of the studies that also evaluated national OELs.
Table 74: Comparison of DNELs from REACH registration dossiers and IOELVs
This study Tynkkynen et al.
(2015)
Nies et al.
(2013)
N (total dataset) 103 87 95
DNEL = IOELV 58 56% 64 74% 71 75%
DNEL ≠ IOELV 45 44% 23 26% 24 25%
Of those with different DNELs and IOELVs
DNEL < IOELV 32 71% 18 78% 14 58%
DNEL > IOELV 13 29% 5 22% 10 42%
Combined evaluation of total dataset
DNEL ≤ IOELV 90 87% 82 94% 85 89%
DNELs < IOELV 32 31% 18 21% 14 15%
This comparison demonstrates that (a) 15-31% of the DNELs are lower than the IOELVs and
(b) 87-94% of the DNELs are equal to or lower than the IOELVs. This result contrasts the
findings of the studies cited above. The most likely but implicit explanation is that national
OELs from Sweden, Finland and Germany are lower than the IOELVs in many cases, but these
studies did not compare national OELs with IOELVs.
The quantitative analysis of non-identical IOELVs and DNELs shows that:
 If IOELVs are higher than DNELs (N=32), the difference is substantial (up to a factor
96) in several cases. For one third of the substances (11/32, 34%), the IOELV is more
than 5-times higher than the DNEL;
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 If DNELs are higher than IOELVs (N=13), the difference is only about a factor of two
on average and a factor of 5 as a maximum.
The following table summarise the results of this evaluation:
Table 75: Comparison of DNELs with IOELVs for non-identical values
IOELV >
DNEL
DNEL >
IOELV
N 32 13
AM 9.1 2.2
MEDIAN 2.7 1.7
GM 3.7 1.9
MIN 1.0* 1.0*
MAX 96 5.0
Number of substances with a > 5-times higher value 11 0
Notes: * Rounded to two significant figures (exact values are slightly higher than 1)
These evaluations support the notion that DNELs are generally equal to or lower than IOELVs.
The high level of agreement between DNELs and IOELVs may signal the use of IOELVs as
DNELs by registrants rather than deriving DNELs based on the REACH methodology (ECHA,
2012). Such an approach is in agreement with provisions in ECHA (2012) allowing registrants
‘to use an IOEL as a DNEL for the same exposure route and duration, unless new scientific
information that he has obtained in fulfilling his obligations under REACH does not support
the use of the IOEL for this purpose’ (ECHA, 2012). In such a case, the application of
assessment factors as specified in ECHA, 2012. becomes obsolete. As noted by Tynkkynen et
al. (2015), ‘registrants have taken advantage of the opportunity to use the IOELV as a DNEL
value as such. It can be assumed that at least in some cases, the DNEL would have been
significantly lower than the IOELV if the default assessment factors published in the REACH
guidance (ECHA, 2012) had been applied.’
The finding that most of the DNELs differing from an existing IOELV are lower than the
IOELV further supports the notion that the application of larger assessment factors will result
in DNELs that are lower than IOELVs. However, DNELs derived under REACH may also
reflect more recent data that may potentially result in a revision of DNELs (presumably towards
lower values in many cases). National OELs may also be lower than IOELVs and a difference
between DNELs and national OELs may therefore not be evident statistically.
Differences between DNELs and values in other regulatory areas (AELs, AOELs, ADIs/TDIs)
AOELs (Acceptable Operator Exposure Levels) and AELs (Acceptable Exposure Levels) are
derived for workers exposed to pesticides and biocides, respectively, and have similar
definitions as DNELs (EC, 2006; ECHA, 2017f)). However, several important differences in
their derivation methodology are obvious. For example, no allometric scaling is recommended
in the draft guidance for setting AOELs (EC, 2006) and is recommended only as a second tier
approach for biocides (ECHA, 2017f). In addition, a higher assessment factor for intraspecies
variability (10) is used in these frameworks compared to REACH (5 for workers in ECHA R.8
Guidance, lower values in national OEL frameworks and in the ECETOC documentation
(ECETOC, 2003; 2010)). Finally, AOELs and AELs for workers are generally derived as a
dose (in mg/kg bw/d; exceptions apply e.g. for local effects), while workers DNELs for
249
inhalation exposure are typically given as a concentration in mg/m3
(Schneider and Dilger,
2019). For a detailed assessment of differences, we refer to the results from the BAuA research
project F2437.196
Similarly, also ADI or TDI values derived for substances in food are derived using a 10 times
10 assessment factor for inter- and intraspecies variability (100 in total), which is numerically
in accordance with the factors recommended by ECHA in the R.8 Guidance for DNELs, oral,
long-term for the general population, if the POD comes from a chronic rat study. However, for
smaller (e.g. mice) or larger species (e.g. rabbit) different factors would result. Nickel salts are
an example for substances, for which values are derived both under REACH and by EFSA
regarding their role as food contaminants. Recently, EFSA proposed a long-term TDI value of
13 µg Ni/kg bw/day.197
A similar long-term oral DNEL for the general population of 11 µg
Ni/kg bw/day was derived in the registration dossier for nickel dichloride.
To obtained more insight into different reference values in different regulatory areas, worker
DNELs derived under REACH were compared with A(O)ELs derived under the BPR for a
larger number of substances. Only long-term inhalation reference values were evaluated for
this purpose. In addition, the corresponding reference values for the general population were
also evaluated as were PNECs for the freshwater (PNECfw) compartment. The following table
shows the results of these evaluations. Cells are empty, when no numerical value has been
derived. In many cases, a reason is provided in the corresponding documentation.
196
BAUA, Derivation of occupational exposure limits for airborne chemicals - Comparison of methods and
protection levels, available at: https://www.baua.de/EN/Tasks/Research/Research-projects/f2437.html
197
EFSA, Scientific Opinion, Update of the risk assessment of nickel in food and drinking water, 2020, available
at https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2020.6268
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Table 76: Comparison of reference values for substances used as industrial chemicals (REACH) and biocides (BPR)
Substance name CAS no. Workers (mg/m3) General population (mg/kg x d) PNECfw (mg/L)
DNEL A(O)EL DNEL ADI/AEL REACH BPR
Acrylaldehyde
(acrolein)
107-02-8 0.2 0.019 7 x 10-5
1.02 x 10-4
Piperonyl butoxide 51-03-6 1.6 1.4 0.221 0.2 0.001 0.00148
3-iodo-2-
propynylbutylcarbamat
e (IPBC)
55406-53-6 0.023 1.4 0.2 0.001 0.0005
Benzoic acid 65-85-0 0.1 (LOC), 3
(SYS)
35§ 16.6 5 0.34 2.5
Biphenyl-2-ol 90-43-7 19.25 2.8 0.4 0.001 0.0006
Boric acid (as mg B) 10043-35-3 1.45 0.7 0.17 2.9 0.18
Bromoacetic acid 79-08-3 2.8 0.054 0.05 0.026 0.01 0.010
Calcium dihydroxide 1305-62-0 1 (LOC) 0.49 0.491
Calcium magnesium
oxide
37247-91-9 1 (LOC) 0.32 0.491
Chlorocresol 59-50-7 6.289 2.1§ 0.892 0.3 0.015 0.015
Coco
alkyltrimethylammoniu
m chloride
(ATMAC/TMAC)
61789-18-2 1 (LOC) 0.00068
Formaldehyde 50-00-0 0.375 (LOC);
9 (SYS)
0.12 (AEC,
LOC)
4.1 No ADI (AEL:
0.15)**
0.44 0.0104
Hydrogen cyanide 74-90-8 0.78 0.7 0.018 No ADI (AEL:
0.1)
0.005 4 x 10-5
Hydrogen peroxide 7722-84-1 1.4 (LOC) 1.25 (LOC) 0.013 0.0126
Mixture of 5-chloro-2-
methyl-2H- isothiazol-
3-one and 2-methyl-
2H-isothiazol-3-one
55965-84-9 0.02 (LOC) 0.02 (AEC) 0.09 0.004 3.39 x 10-3
4.9 x 10-5
251
Peracetic acid 79-21-0 0.56 0.5 (AEC) 1.25 0.002
(intermittent
release)
6.9 x 10-5
Potassium sorbate 24634-61-5 17.63 93.8§ 2 13.4 1
Propan-1-ol 71-23-8 268 64.4 61 9.2 6.83 2.3
Propan-2-ol 67-63-0 500 125 26 10.7 140.9 2.82
Notes: AEC: Acceptable exposure concentration, LOC: local effects, SYS: systemic effects
* AEL in mg/kg x d multiplied by 70 kg and divided by 10 m3/d; rate and extent of absorption via relevant pathways considered as given in assessment report (100% for both pathways assumed,
if no specific data given). ** Non-professional primary use excluded. § ADI derived for non-professional user. No AEL derived for workers.
252
These comparisons of substances assessed both under the BPR and under REACH and
biocides can be summarised as follows:
Reference values derived under REACH (DNELs/PNECs) exist for more substances
than reference values under the BPR. This finding is likely due to the fact that such
values are derived under the BPR only if they are needed. For example, an ADI is
generally derived under the BPR only, if exposure via food or feed is likely.
While some identical (or very similar) values are derived under the two regulatory
frameworks, DNELs and PNECs are generally higher than the corresponding
reference values derived under the BPR. This applies to 75% (workers), 80%
(general population) and 56% (PNECs) of the cases.
Larger differences with the reference value derived under REACH being more than
10-times higher than the one derived under the BPR occur in 13% (workers), 20%
(general population) and 31% (PNECs) of the cases.
For each substance, a substance-specific assessment would be needed to gain further insight
into the reasons for the differences.
It must be noted that A(O)ELs are derived as body doses in most cases and conversions to
inhalation exposure concentrations were necessary for this comparison with respect to
workers. This conversion was done in a generic way based on the summary absorption rates
given in the BPR assessment reports. A substance-specific assessment may have resulted in
different outcomes. Interestingly, for the two substances, for which an AEC was reported in
the BPR assessment report, these values are practically identical to the DNELs derived
under REACH.
Consequences
Companies may use various toxicity values or develop their own where EU-reviewed
reference values may already be available. Moreover, within the same reference or limit
values, there are often various limit values differentiated by factors such as workers and
general populations, adults and children, short- and long-term effects, local and systemic
effect and different routes of exposure.
Risk assessment conclusions for the same substance may hence differ depending on the
input reference value used and may be perceived as inconsistent even when they are
justified. In addition, reference values may be derived using different methodologies, which
may lead to incoherent outcomes.
Diverging DNELs or PNECs in different REACH registration dossiers for a substance have
been identified. Though the evaluations for worker DNELs do not suggest that the problem
is widespread, such divergence seems to come from deviations from the relevant ECHA
guidance (Schenk et al., 2015; Schenk et al., 2014). This could lead to incoherent outcomes
as these end-points are passed on throughout the supply chain and downstream users may
be prevented to place their products on the market as wrongly assumed as not safe or place
them on the market, where the use of them is eventually not safe.
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Drivers
Different toxicity reference values for the same substances may lead to inconsistencies in
the outcomes of risk assessments and to the inefficient use of limited resources. The
existence of different values depends on a range of justified and less justified reasons:
differentiation by workers and general populations, adults and children, short- and
long-term effects, local and systemic effect and different routes of exposure;
use of different methodologies;
availability, access and use of different studies;
visibility of EU-reviewed reference values, which may be ignored by companies and/or
authorities deriving their own values.
How likely is the problem to persist?
The CSS highlights the “one substance, one assessment” (OSOA) approach as a possible
way to produce more coherent results. The Commission committed to create a repository of
toxicity reference values to promote their reuse and harmonisation among EU risk assessors
and managers. However, a repository can only be the first step, as the various methodologies
for deriving reference values in different regulatory areas have been developed historically
and may not be easily harmonised. For example, methodologies for deriving OEL values at
the EU and Member State levels differ as do DNELs derived under REACH and OELs.
Furthermore, even DNELs or PNECs derived by registrants under REACH may differ,
because of different assessment factors or points of departure.
EFSA, the Commission and ECHA have already made some efforts to compile and make
toxicity reference values available. ECHA has developed and operates the EU Chemicals
Legislation Finder (EUCLEF)198
, an online service offering the possibility to navigate
through the EU chemicals legislative framework, providing substance-based information
from 56 pieces of EU chemicals legislation. EUCLEF lists some health-based limit values
derived and applicable under these legislative pieces. EFSA maintains the OpenFoodTox
database199
, which summarises the outcomes of all hazard identification and
characterisation performed by EFSA on plant protection products and contaminants, food
improvement agents and feed additives for human health, animal health and the
environment. The Commission (DG SANTE) maintains the EU pesticides database200
,
which is the official source for pesticide MRLs in food products. The database also lists
AOELs, ARfDs and ADIs.
POTENTIAL POLICY MEASURES
Baseline
Already some initiatives or measures may be envisaged as developing harmonised toxicity
reference values and more may be expected in the future. For example, the restriction under
REACH of the aprotic solvent N,N-dimethylformamide201
to fix a ‘harmonised DNEL’ for
198
https://echa.europa.eu/information-on-chemicals/euclef
199
EFSA, Chemical Hazards Database, available at: https://www.efsa.europa.eu/en/data-report/chemical-
hazards-database-openfoodtox
200
Pesticides Data base, available at https://ec.europa.eu/food/plants/pesticides/eu-pesticides-database_en
201
See REACH restriction: undefined (europa.eu)
254
workers (inhalation and dermal) that shall be used by registrants of this substance in their
chemical safety report in order to determine the relevant risk management measures for
worker protection.
The differences between legislations are also evident in other examples. In the case of nonyl-
and octylphenols, EQS were derived under the Water Framework Directive. These may be
considered ‘harmonised reference values’. However, based on the RAC statement related to
the corresponding nonylphenol and octylphenol ethoxylates (ECHA, 2017), it appears
questionable that these EQS may be accepted as a threshold in applications for authorisation.
The same is true is even true within a single regulatory area. For example, the DNEL derived
by RAC for dibutyl phthalate in 2013 may be considered a ‘harmonised DNEL’. With the
addition of this substance to REACH Annex XIV for endocrine disrupting properties
(human health), the validity of this reference value is unclear and RAC was not in a position
to derive a DNEL for these effects (ECHA, 2021). Again, diverging OELs are legally in
place in several EU MS.
The reference values established by regulatory agencies are not necessarily lower than those
derived e.g. by registrants under REACH. For example, different studies were often
available to REACH registrants for deriving PNECs compared to the ones available to the
competent authority for the same substance under the BPR. In some cases, REACH
registrants have derived lower PNECs than authorities under the BPR and it may not be the
most meaningful approach to establish the latter as ‘harmonised PNECs’.
It is assumed that the Commission would establish the repository of toxicity reference values
as for its commitment as part of the OSOA approach in the CSS, with the aim of promoting
the reuse of the values among EU risk assessors and managers. It is also assumed that EU
agencies would establish a central coordination mechanism, which would ensure better
distribution and coordination of tasks and access to all data by all agencies, as advocated by
ECHA and EFSA in their joint position paper202
.
Policy options
The purpose of harmonising reference limit values is to support EU risk assessors in their
specific regulatory framework. They are based on findings that different reference values
may exist for a given substance under different regulatory frameworks (or even within the
same as for example of different DNELs in registration dossiers). This situation not only
lacks transparency for interested stakeholders but may also indicate inefficiency since
reference values for the same purpose (e.g. workers protection) may have been derived by
different bodies in parallel. Ultimately, different reference values for the same substance
may result in different risk assessment conclusions that may be perceived as inconsistent
and are difficult to communicate even if they are justified.
Against this background, the OSOA approach has been highlighted in the EU chemicals
strategy for sustainability as a possible way to produce more coherent results. In this wider
context, harmonised reference values may be an element to support an OSOA approach for
use by different bodies in different regulatory areas. Such harmonised reference values may
reduce inconsistencies and result in more efficient and effective use of resources.
202
https://www.efsa.europa.eu/en/corporate/pub/osoa
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A detailed discussion of the differences in methodologies for deriving DNELs and PNECs
(as well as related reference values) is provided above, including evaluations of substance-
specific reference values under different regulatory frameworks and statistical evaluations.
For example, methodologies for deriving OEL values in the EU and in Member States differ.
In addition, the methodologies for deriving DNELs under REACH are different from the
ones applied in OEL derivation in Member States. Furthermore, even DNELs or PNECs
derived by registrants under REACH may differ, e.g. by using different assessment factors
or points of departure. It is also noted that it may not be meaningful to harmonise all
approaches and the CSS specifically notes that the OSOA approach (emphasis added) ‘aims
to ensure that methodologies are made more coherent and to the extent possible
harmonised’.
Since the Commission proposal considers harmonised DNELs and PNECs particularly
valuable for substances with widespread uses in different regulatory areas, the
considerations above may serve as a critical appraisal of the proposal. It is also noted that
the EFSA/ECHA joint position paper on OSOA does not propose any form of harmonised
reference values, but rather three organisational pillars for the OSOA approach by EU
agencies (central coordination mechanism, better distribution/coordination of tasks and
access to all data by all agencies).
Some CARACAL members suggested to include harmonised NOAELs for toxicological
effects and NOECs for ecotoxicological effects in the CLP Regulation rather than DNELs
and PNECs. This suggestion is based on the consideration that different assessment factors
are used in different regulatory frameworks.
In most regulatory frameworks, reference values are calculated considering results from
different key studies by (a) adjusting the experimental POD (point of departure; e.g. a
NOAEL, NOEC) to human/environmental exposure and (b) applying assessment factors.
The study resulting in the lowest reference value will ultimately be used for deriving the
reference value. This may - depending on the substance and the available data – involve
many studies for different endpoints, in some cases also a differentiation of local and
systemic toxicological effects. Since the approach involves several steps, the study resulting
in the lowest reference value may not have the lowest NOAEL/NOEC.
If a harmonised NOAEL is included in the CLP Regulation, different reference values may
still be derived under different regulatory frameworks because of non-harmonised
methodologies (e.g. different adjustments for human exposure and/or assessment factors
being applied). In fact, RAC and SCOEL recognised in their joint report on OEL derivation
that in addition to diverging assessment factors ‘the way in which the adjustment of the
POD for exposure was carried out could be more critical to the final result than previously
thought’ (ECHA/RAC-SCOEL, 2017).
The most suitable key study and POD may will also depend on the specific reference value
it will be used for. If an inhalation reference value is to be derived for a given substance,
preference will generally be given to a key study involving inhalation exposure due to the
limitations of route-to-route extrapolation (Schneider and Dilger, 2019). If the same
substance is used e.g. in food contact materials and a reference value needs to be derived,
preference will generally be given to a key study involving oral exposure.
256
Provision of NOAELs or NOECs – in some sense – make matters more complicated than
inclusion of reference values. For example, benchmark doses (rather than NOAELs) are
increasingly used for toxicological endpoints. Benchmark doses may be derived as a central
estimate (BMD) or the lower bound of the confidence interval (BMDL). The extent of using
benchmark doses and the specific POD used (BMD, BMDL)203
differ between different
regulatory frameworks (Schneider and Dilger, 2019).
These considerations demonstrate that a POD (e.g. a NOAEL) does not exist in a vacuum
but must always be seen in the context of its intended application. In some cases, both an
inhalation and an oral POD would be needed, and the underlying key studies may differ
substantially (e.g. an epidemiological study for the inhalation POD and a study in
experimental animals for an oral OEL). The POD may be given as a NOAEL for some
substances and as a benchmark dose for other substances. Consequently, substantial
contextual information would need to be provided in addition to the value as such.
Even if a single NOAEL could be provided for a given substance, different reference values
(e.g. a DNEL under REACH and an A(OEL) under the BPR) may still result due to
differences in methodology and/or scientific assessment. Therefore, the OSOA principle
appears as not being fulfilled. Ultimately, these considerations suggest that the OSOA
principle cannot be simply implemented by providing single values (as long as
methodologies are not harmonised), which is also suggested by the proposals of the
EFSA/ECHA joint position paper on OSOA.
On the basis of the problem described above as different agencies and expert committees
derive toxicity reference values with different methodologies and using different studies:
the following policy measures have been identified:
 Provide harmonised toxicity reference values (DNELs/PNECs or N/LOAEC and/or
N/LOAEL) in CLP Annex VI (CLH) or new annex;
 RAC opinions include the derivation of point of departures (NOAEL/NOAEC)
when performing the review of CLH dossiers for the hazard classes under the scope
of the CLH dossier.
 Create a repository of toxicity reference values;
 Create a central coordination mechanism to harmonise toxicity reference values
across different chemical regulatory frameworks.
Stakeholders’ views
With regard to toxicity reference values, the analysis of the Open Public Consultation
position papers has shown a very high variation in opinions with some of them clearly out
of the scope this issue. For instance, some respondents discussed the issues of hazard
identification or animal testing. Such variance demonstrates that the problem is not
sufficiently visible, discussed or understood by the stakeholders. In open questions of the
TSS, the respondents were focused on toxicity reference values; however, many of them
pointed out that the issue of hazard quantification is out of the scope of the CLP Regulation.
It should be noted, however, that the views of business entities were mostly represented in
the TSS due to a very low participation rates of public authorities and non-governmental
203
As an additional element, the benchmark response (also called critical effect size) associated with a BMD
or BMDL must be provided, but this issue is not discussed here further.
257
organisations. In the interviews, the respondents also indicated that the issue is out of CLP
scope. However, the interviewees commented that different toxicity reference values
emerge due to various reasons (e.g., data or knowledge available as well as different
methodology, different levels of scientific quality, etc.).
Similarly, although in general, CARACAL members were supportive to harmonisation of
toxicity reference values, they did not see how the issue of diverging toxicity reference
values fit the CLP Regulation.
SCREENING AND ASSESSMENT OF THE POTENTIAL MEASURES
Discarded policy options
Include in RAC opinions the derivation of point of departures (NOAEL/NOAEC) when
performing the review of CLH dossiers for the hazard classes under the scope of the CLH
dossier. While this may entail a lower workload due to the limitation to selected endpoints
— although falling on RAC rather than dossier submitters — such an approach has several
limitations:
CLH dossiers are usually limited to a consideration of specific endpoints/hazard classes
(e.g. CMR properties, respiratory sensitisation and ED properties in the future). The point
of departure will only relate to these endpoints. The NOAEL/NOAEC values for other
endpoints (i.e. the ones not subject to the CLH dossier) may differ from (and in some cases
may be lower than) the one derived under this option. Consequently, the point of departure
derived under this option may not be used in the derivation of reference values, which
requires a consideration of all endpoints. In essence, providing a point of departure in a CLH
dossier will always involve the uncertainty of whether consideration of other endpoints
would result in lower points of departure or reference values).
Since CLH dossiers focus on endpoints that are considered (by RAC and other EU
institutions) to reflect non-threshold effects in many/most cases (e.g. carcinogenicity,
endocrine disruption), deriving a simple point of departure may not be feasible. In such
cases, exposure-risk (or dose-response) relationships will need to be established and it will
remain unclear how these relate to points of departures for other endpoints.
There may be a complex relationship between pathways of exposure, mechanisms of action
and the endpoints considered (e.g. non-threshold carcinogenicity following inhalation, but
not dermal, exposure and threshold-based reproductive toxicity involving all pathways of
exposure in the case of hexavalent chromium).
Overall, it does not appear meaningful to derive a point of departure without a consideration
of the complete toxicological profile of a substance.
Create a repository of toxicity reference values: Assumed to be part of the baseline. The
Commission has launched a call for tenders for designing the repository and collating
information. This belongs to the baseline.
Create a central coordination mechanism to harmonise toxicity reference values across
different chemical regulatory frameworks: This is to be assessed by a study focusing on the
one substance, one assessment approach. Such a central coordination mechanism, proposed
258
in the ECHA and EFSA Joint position paper on one substance - one assessment would
include a coordinated problem formulation phase (i.e. identifying the correct scientific
question that needs to be answered) which would enhance predictability for industry. This
may include a public EU coordination registry, potentially developed from ECHA’s PACT
(Public Activities Coordination Tool), to increase transparency and predictability on
substance-specific activities by authorities across different chemical regulatory frameworks.
Retained policy options
The harmonisation of methodologies is a difficult endeavour and is outside the scope of the
CLP Regulation. However, the measures under consideration propose to add a procedure to
the CLP Regulation to derive and publish harmonised human and environmental
toxicological reference values along the following lines:
‘Introduction of the possibility to insert in a CLP CLH dossier or in a stand-alone dossier a
proposal for a harmonised value of human and environmental toxicological reference values
when considered appropriate by the dossier submitter (e.g. REACH data are available etc.).
The dossier will be assessed by the Agency in the usual way. Once an opinion is provided
including a proposal for a harmonised human and environmental toxicological reference
values, the Commission will consider its insertion in Annex VI or in a new Annex.
Downstream regulation might want to refer to the harmonised CLP human and
environmental toxicological reference values in their specific framework. However, it will
be left to these legislations to assess any direct link or specific requirement to follow CLP
harmonised values’.
Description of Impacts - Administrative burden on businesses and public authorities
The harmonisation of reference values would lead to increased administrative costs on
dossier submitters, and therefore in particular on public authorities. Based on the experience
with CLH, it can be assumed that economic operators would only rarely submit dossiers for
harmonised DNELs/PNECs or N/LOAECs and/or N/LOAELs. Moreover, businesses
wishing to submit proposals may not have access to the same level of data accessible by
public authorities.
The following table summarise workload estimates for the dossier submitter under the
assumption that a stand-alone dossier is submitted. The workload may be lower if a
combined CLH/harmonised DNEL/PNEC dossier is submitted, but this can only be judged
on a case-by-case basis and most likely only affects human health. The workload estimates
do not change if NOAELs and NOECs are derived instead of DNELs and PNECs. The
question whether harmonised DNELs are derived in a stand-alone dossier or together with
a CLH dossier. In the latter case, the workload for harmonised DNELs (but not PNECs)
may be lower depending on the extent to which the relevant studies for classification and
DNEL derivation overlap. However, it is estimated that the additional workload for RAC
to derive NOAELs and NOECs for the hazard classes under the scope of the CLH dossier
under AARAC assessment is low.
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The impact of the factors mentioned above is far higher than the workload associated with
the actual derivation of DNELs and PNECs. Furthermore, resulting reference values need
to be calculated anyway for selection of the most adequate NOAEL/NOEC.
Table 77: Workload estimates (in person-days) to derive harmonised DNELs and PNECs or NOAELs and
NOECs (derivation only)
Available
dataset
Harmonised
DNELs*
Harmonised
PNECs**
Total person-days (FTEs)
Low 5 5 10 (0.045 FTE)
Medium 15 12 27 (0.123 FTE)
High 25 20 45 (0.205 FTE)
Notes: * Workers (inhalation and dermal, long-term, systemic effects) and general population (inhalation, dermal and
oral, long-term, systemic effects). ** All compartments envisaged in ECHA (2008).
Due to the various factors affecting the workload, these figures have a high degree of
uncertainty, and the ‘high’ values should not be taken as maximum values. The figures
presented in the table above are the estimated additional resources required to derive these
reference values by the dossier submitters. Through the analysis of the database of CLHs
maintained by ECHA, it is not possible to identify how many CLHs have been submitted
by industry and how many by MSCAs. However, a close proxy can be derived through the
analysis of the registry of intention for CLHs, which reveals that industry actors submit 2%
of CLH dossiers. By considering an average of 55 CLH dossiers being submitted per year,
the administrative burden for MSCAs is estimated at 6.8 FTEs per year (or present value of
€0.6 million; discount rate: 3%; period: 2023-2043). As noted above, the support services
by ECHA and the development of the RAC opinion need to be accounted for. The necessary
resources are considered proportional to the time required to derive DNELs and PNECs or
NOAELs and NOECs, and are therefore extrapolated from the estimates provided by ECHA
on the support and RAC opinion development on CLH dossier.
Table 78: Workload estimates including ECHA support services and RAC opinion development
DNELs/PNECs or
NOALEs/NOECs
derivation
FTEs % of required resources
to develop a CLH
dossier (0.35 FTE)
RAC opinion
development
ECHA
support
services
Low 0.045 13% 0.013 FTE 0.007 FTE
Medium 0.123 35% 0.035 FTE 0.018 FTE
High 0.205 58% 0.058 FTE 0.029 FTE
The additional burdens of 1.9 FTE per year (CI: 0.7 – 3.2 FTEs) for the RAC to develop an
opinion on the derived reference values and 1 FTE per year (CI: 0.4 – 1.6 FTE) for ECHA
CLP support team to support the process, although low, would impact on the already
strained capacity of the RAC and ECHA CLP support team. The present value (discount
rate: 3%; 2023-2043) of the costs for RAC opinion development are estimated at €0.4
million and for ECHA support services at €0.2 million.
Harmonised DNELs have the potential of ensuring a more consistent application of the
methodology established under REACH. While the derivation of harmonised
DNELs/PNECs may reduce the issue of diverging values observed in REACH registration
dossiers (Schenk et al., 2015; Schenk et al., 2014), they would need to be accompanied by
260
additional (regulatory and non-regulatory) clarifications to tackle inconsistencies across
different legislative frameworks. In particular, there is the risk that legally binding reference
values may contradict legally binding national values under other legislation (e.g. DNELs
vs. national OELs based on EU IOELVs), and non-legally binding values may cause
confusion, as there may be already legally binding values under different legislation.
However, it should be noted that having derived POD (NOAEL, PNEC) by RAC could
represent a good starting point for both economic operator or competent authorities to derive
their reference values.
If harmonised DNELs or PNECs are derived for substances relevant under REACH and
other several regulatory areas (workplace, biocides, plant protection products, food
contaminants etc.), for which legislations and guidelines for assessment are in place, the
following relevant issues are identified:
Regulatory clarification would be required regarding the status and relevance of harmonised
DNELs and PNECs for these regulatory areas. Already under the existing legal framework
the obligation to derive DNELs when an OEL is established was identified as a problem for
companies (RPA et al., 2017). While the Commission proposal suggests that ‘downstream
regulation might want to refer‘ to such harmonised DNELs/PNECs, the legal character
would need to be clearly defined:
If e.g. harmonised DNELs are legally binding, it may contradict legally
binding national OELs (based e.g. on an EU IOELV);
If harmonised DNELs/PNECs are not legally binding, it may cause confusion since the
classification for the same substance is legally binding.
Harmonised DNELs and PNECs would automatically gain special importance and attention.
Therefore, harmonisation of the methods to derive similar health-based values in the various
regulatory areas would become necessary to avoid inconsistencies. Setting harmonised
DNELs/PNECs or NOAELs/NOECs may then be seen as an incentive to harmonise
methodologies across regulatory frameworks. However, if such a methodological
harmonisation is not taking place, different values will continue to exist. It may therefore
be argued that harmonisation of methodologies – where meaningful – is a prerequisite to
obtain more coherent reference values rather than a consequence of harmonised
DNELs/PNECs/ NOAELs/NOECs.
The evaluations show that:
IOELVs cannot be taken directly as a basis for harmonised DNELs, since the methodology
for their derivation deviates from the DNEL methodology. Noteworthy, DNELs are equal
to or lower than IOELVs in 15-31% of the cases based on evaluations performed in this
study and by others (Nies et al., 2013; Tynkkynen et al., 2015)
AELs and PNECs derived under the BPR – while derived using similar methods as applied
under REACH – often differ from DNELs and PNECs derived under REACH. Illustrative
cases of PNEC derivation under both regulatory frameworks suggest that differences are
not due to differences in methodology (e.g. the application of assessment factors), but rather
result from the use of different studies for PNEC derivation. This observation suggests that
study/data availability is an element to consider in addition to harmonisation of
methodologies as was also noted in the EFSA/ECHA joint position paper on OSOA.
261
Numerical values of DNELs are subject to changes when new data becomes available.
Although harmonised classifications may also require updates with new information
becoming available, numerical values are expected to be more likely subject to changes than
the qualitative evidence on e.g. CMR endpoints. In contrast to qualitative evidence for
classification, harmonised DNELs/PNECs would need to be checked for newly available
data and for the potential need for updates on a regular basis (e.g. every two years).
The update of reference values is expected to happen more frequently than updates to CLH
dossiers and it would therefore be more difficult. Moreover, their inclusion in Annex VI or
separate Annex would not necessarily result in one value for one substance. While it could
be an incentive to harmonise methodologies, harmonised methodologies are a pre-requisite
to more coherent reference values. In addition, data availability to the dossier submitter
needs to be considered.
In summary, it is concluded that the inclusion of reference values in CLP would not add
sufficient benefits, if considered against the increased effort required by dossier submitters,
ECHA and RAC.
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Annex 10 – Allowing COM to initiate CLH &
Improving prioritisation of CLH
CONTEXT
CLP is the primary basis for most chemical hazard assessment and classification in the EU.
According to the Chemical Fitness Check, the CLP Regulation is effective and is considered
by the majority of stakeholders as an improvement over the earlier Directives that it replaced
in 2008. Some issues, however, were identified with respect to the pace and focus of
harmonised classifications.
The harmonised classification is an important instrument for achieving the safe use and
enhancing the substitution of hazardous chemicals204
. Such classifications are compulsory
throughout the EU to ensure adequate information and risk management. It is also linked
with various processes laid down in other sectorial regulations, which need a certain and
EU-wide harmonised classification as a basis. As an example, the approval processes for
plant protection product (PPP) and biocidal product (BP) active substances require a
harmonised classification for all hazard classes under the CLP Regulation.
Article 36 of the CLP Regulation requests that substances that fulfil the identification
criteria for carcinogenicity, mutagenicity, reproductive toxicity category 1A, 1B or 2 and
respiratory sensitisation category 1, substances that are biocidal or plant protection product
active substances should be classified and labelled in a harmonised way in the EU. Other
substances may also bear a harmonised classification on a case-by-case basis for justified
reasons. A harmonised classification (i.e., CLH) dossier may be submitted in order solve
diverging self-classifications identified in the Classification and Labelling Inventory (CLI)
(see Annex CLI). The procedure for the preparation and submission of CLH proposals is
laid out in Article 37 and described below.
The CLH process is usually initiated by an MSCA or manufacturer, importer or downstream
user, by submitting a CLH intention, although the latter is not a formal requirement. This is
followed by the submission of the CLH dossier – a document that contains sufficient
information to allow an independent assessment of physical, health and environmental
hazards of a substance. The CLH procedure consists of four main steps:
initiation of the CLH process;
preparation of a CLH dossier for the RAC;
development of RAC opinion; and
Commission’s decision concerning the inclusion of the substance and the CLH in
Part 3 of Annex VI to the CLP Regulation.
These are preceded by preparatory work (screening/grouping, regulatory risk assessment
and generation of further information and assessment) to make the CLH process more
targeted and to identify relevant substances for CLH (Figure 68). A more detailed overview
of the steps and their efficiency is provided in Annex V.
204
See chemical Fitness Check, SWD(2019) 199.
263
Figure 68: CLH procedure – Adapted from ECHA
DESCRIPTION OF THE PROBLEM
According to the chemicals Fitness Check197
, the number of assessments for harmonised
classifications under the CLP Regulation is relatively low compared to the likely number of
chemicals which merit a harmonised classification205
. The speed of the procedures for CLH
was assessed as slightly to mostly satisfactory. All categories of stakeholders agreed that
there is still rooms for improvement.
Considering harmonised classification and labelling, the feedback to the open questions as
well as position papers in the OPC have shown that the respondents206
did not have a clear
understanding about the nature of problems in this area. Such outcome is due to CLH being
a specific process that requires certain knowledge to make judgements on it. In the TSS that
mostly represented the views of businesses, the latter disagreed in their conclusions about
CLH. Two opposite opinions dominated in open comments to the TSS with some
respondents considering CLH an inefficient process (e.g., in terms of time, organisation of
procedures, etc.), while others believed that CLH is properly organised and shows a good
performance. In interviews, some respondents noted the lack of scientific quality and fair
prioritisation of substances for CLH, while others were completely satisfied with the CLH
procedure. In their written feedback about CLH, some CARACAL members highlighted
that ECHA and RAC work to maximum capacity that may indicate the lack of additional
resources for CLH.
Limited capacity working at full speed
205
ECHA ''Authorities to focus on substances of potential concern – Roadmap for SVHC identification and
implementation of REACH management measures – Annual report' (2018) p. 13
206
It was noted that many Member State Competent Authorities favoured providing input to the ad-hoc
CARACAL consultation rather than replying the Open Public Consultation.
Preparatory work facilitating the
development of CLH dossiers
Generation
of new data
Regulatory
Management
Option
Analysis
Screening
/
Grouping
264
Firstly, RAC has been processing around 50 to 60 dossiers every year since 2017, close to
full capacity. ECHA estimates that 60 dossiers are the maximum the ECHA CLH team and
RAC can process with the current capacity of 50 members and 5 co-opted members207
. The
timeline and regulatory deadlines for the CLH procedure208
are always met by RAC, except
for 10 opinions in 2020 which were delayed because of the COVID-19 pandemic. The
current speed also reflects the need to ensure that all the relevant opinions, including
stakeholder views, are taken into account. The transparency with which RAC opinions are
developed was highlighted in the Chemical Fitness Check.
The availability of limited resources working at full capacity results in a slow increase of
the number of harmonised classifications in Annex VI of the CLP Regulation (Table 78).
As of 2022, 4,335 entries209
have harmonised classifications. Harmonised classifications
and labelling of hazardous substances are introduced and updated through the Adaptations
to Technical Progress (ATPs), issued yearly by the European Commission. The adoption of
the RAC opinions and the inclusion of CLH in Annex VI by the Commission also requires
resources and an increase in CLH may result in bottlenecks also at this final step.
Table 79: Number of new substances with CLH (2008-2022)
ATP Application date No. of substances
CLP00 2008 3,368*
ATP01 2010 758**
ATP03 2012 11
ATP05 2012 22
ATP06 2014 14
ATP07 2016 19
ATP09 2018 26
ATP10 2018 24
ATP13 2020 16
ATP14 2021 17
ATP15 2022 37
Source: Analysis of all CLH from: https://echa.europa.eu/information-on-chemicals/annex-vi-to-clp
Notes: *Harmonised classifications implemented under Directive 67/548/EEC; ** ATP01 brought the entries from
the 30th ATP & 31st ATP of Directive 67/548/EEC into Annex VI of CLP
It should be noted that ECHA and RAC have identified the limited resources of RAC as a
bottle neck for CLH output200
. They have come up with the following improvements that
are already in place. In 2018, a fast track procedure was introduced by RAC for identifying
non‐controversial endpoints ahead of the plenary, saving time in the plenary to focus on
points that are more difficult. ECHA indicated that since this was introduced, 65% of
classification proposals for such endpoints went through without a plenary discussion. In
2021, ECHA set up a working group to RAC for the assessment of CLH dossiers. This gives
more room for detailed discussion. The plenary meeting would then decide on a more
mature draft opinion; again saving time.
207
See presentation by RAC at CARACAL 43. It should be noted that currently RAC operates with ony 44
members in total.
208
Article 37(4) of the CLP Regulation states that RAC should ‘adopt an opinion on any proposal submitted
pursuant to paragraphs 1 or 2 within 18 months of receipt of the proposal, giving the parties concerned the
opportunity to comment.’
209
Some of the entries of Annex VI are group of substances (e.g. the metal compounds), so the number of
substances is higher.
265
Secondly, most of the CLH dossiers submitted are developed by Member State Competent
Authorities. When covering plant protection product or biocide active substances, only
MSCAs can submit CLH dossiers. There are limited resources of Member States resulting
also an uneven and limited contribution to CLH proposal submission (see Figure 69:).
(Milieu Consulting, 2020; ECHA, 2021b). The situation reported in 2019 (fitness check) is
a reflection of the high resource needs (staff/expert capacity) at Member State level for
preparing a CLH dossier, combined with reductions in resources and budgets allocated for
this work in many Member States, in particular following the 2008 financial crisis. There is
also considerable variation between Member States in their capacity and willingness to
initiate CLH dossiers with just a few Member States carrying the majority of the burden
(see Figure 69:). It is understood that the situation has not improved during the COVID
pandemic.
Figure 69: Number of dossiers submitted per Member State in 2008-2020. Source: reproduced from ECHA
(2021b). Notes: *Member State until 31 January 2020
Out of 27 Member States, only 22 submitted a CLH since the CLP Regulation was adopted.
A smaller subset of 13 submitted CLH dossiers for industrial chemicals indicating that out
of 27 Member States, only some have resources to perform this task. Only 11 out of the
current 27 Member States submitted more than 1 CLH dossier on average per year and 6 of
them managed to submit more than 2 per year.
On a more positive note, in 2020, CLH procedures were initiated for a substantial number
of substances (100), but even a higher number (125) was pending the initiation of CLH
process, which is far more than what RAC can handle if all intentions are transformed into
submitted dossiers.
A high number of substances which deserve a harmonised classification
266
First, the number of industrial chemicals, which are identified as deserving a harmonised
classification according to the current hazard classes in the CLP Regulation, increased every
year (see Figure 70). From the figures reported, this development is quicker than what the
CLH process can deliver. ECHA’s integrated regulatory strategy (IRS)210
screening and
grouping system has resulted in the identification of a long list of substances proposed for
regulatory risk management action, including CLH. Significant progress – a ten-fold
increase in the number of screened substances per year compared to 2014-2018 – was
achieved in 2020 due to the introduction of the grouping approach (ECHA, 2020; ECHA,
2021b).
Figure 70: Number of industrial substances requiring CLH identified through the IRS – Source: data
provided by ECHA
Red line: 60 RAC opinions per year maximum, grey line: 33 RAC opinions per year maximum for industrial
chemicals.
Second, the number of substances for which a CLH dossier is needed may further increase,
following deeper checks of available information by ECHA. The rolling out of the following
actions from the Chemicals Strategy for Sustainability211
(CSS) may also increase the
number of CLH dossiers. First, more knowledge information may be requested and
generated for low-tonnage registered substances. Furthermore, additional hazard classes are
proposed to be included in the CLP Regulation. In addition, there is the need of harmonised
classifications to apply generic risk management approach under REACH and other
sectorial legislation. The consequence is that more suspected substances of concern may
receive harmonised classifications with additional delay in the future, resulting in
inconsistencies in risk management measures adopted by the actors along the supply chains
but also in a further delayed application of the regulatory Risk Management Measures
210
Integrated Regulatory Strategy (IRS), which ECHA has been implementing since 2016 as a follow-up to
the SVHC Roadmap. The IRS aims “to accelerate data generation, identification of groups of substances of
concern, and regulatory action”. The goal is “to clarify by 2027 which registered substances are a high priority
for regulatory risk management or data generation, and which are currently a low priority for further regulatory
action” (ECHA, 2021b).
211
COM/2020/667 final
25
70
103
178
0
20
40
60
80
100
120
140
160
180
200
2018 2019 2020 oct-21
267
(RMMs), because of the failure in triggering RMMs in vertical legislation referring to CLP
hazard classification.
Second, a large part of the CLH dossiers cover active substances used in plant protection
and biocidal products (see Figure 71). This explains the fact that relatively few harmonised
classifications have been developed for REACH-registered industrial chemicals and almost
none for chemicals not registered under REACH. As shown below, CLH dossiers for active
substances represent 45 % of the submitted dossiers. Interestingly, the share of submitted
dossiers which don’t meet provisions of either Article 36 (1) (CMR or respiratory sensitising
substances) or Art 36 (2) (PPP or BP active substances) increased steadily to 16.5 % in
2021. So far, no submitted CLH dossier has been rebutted for not meeting the criterion in
Article 36 (3), as justification was always assessed as sufficiently relevant by ECHA and
RAC.
Figure 71: Number of CLH intentions according to the justification according to Art. 36 for CLH
(Note: withdrawn intentions out or CLH dossiers submitted without prior intention) ECHA’s CLH Registry
of Intention, consulted on 24/2/2021)
The main consequence of this ‘slow’ pace is that not all hazardous industrial chemicals are
identified and/or identified in an unambiguous way (see section CLI). This hence may
prolong exposure of EU citizens and environment to such hazardous chemicals.
In the period 2016-2020, there has been a steady increase of CLH dossiers for CMR
substances (71 in total) (ECHA, 2021c). The IRS has accelerated the screening of registered
substances and the identification of those requiring the generation of further data or risk
management. Without intervention in the coming years, the rhythm of CLH adoption is
assumed to stay constant, as ECHA and RAC work at full capacity and MSCAs’ resources
remain limited. Also, the workload is assumed to remain uneven, with just a few MSCAs
carrying most of the burden.
Beyond the question on the too small annual volume of opinions, there is a question whether
there are synergies to be identified in the current and/or future CLH process. Recently
ECHA has improved their screening process by grouping related substances. Such grouping
0
100
200
300
400
500
600
700
800
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
Active substance CMR Other justification
268
is based on read-across and chemical similarity. The same reasoning could also be applied
to CLH dossiers, which could be developed for a group of substances. CLH dossiers take
advantage on the approaches mentioned above by using information on similar substances
but so far a very limited number of dossiers for grouped substances has been submitted. In
2020 and 2021, RAC issued two opinions on small groups of substances, one for 2-
ethylhexanoic acid212
and its salts and one for 3 lithium salts213
. It should be noted that so
far, grouping under CLH process has been limited to substances sharing the same toxic
moiety. The European Commission will soon contract the development of a larger CLH
dossier for 40 phthalates, called for by the Roadmap214
for restriction. If this grouping
approach can be applied to CLH processes, the increased pace of IRS will also be addressed
by CLH dossiers submitted for groups of substances.
RAC opinions cover both CLH for new substances and revisions of existing CLH. In the
last 10 years (2012-2022), 209 new substances have received CLH (median of 20.5 per
year). Following the adoption of the opinion on the CLH of a substance by the RAC, the
European Commission takes a decision and publishes the updated list in an ATP. Table 79
presents the estimate of the number of substances with CLH that could be expected in 2030
and 2040, calculated as the linear forecast of the number of substances with CLH based on
the values from ATP03 to ATP17 (2012-2022).215
Table 80: Estimates of the number of CLH substances in 2030 and 2040
2022 2030 2040
Linear forecast 4,385 4,450* 4,600*
Notes: *rounded to the nearest 50s.
POTENTIAL POLICY MEASURES
According to Recital 16 of CLP, harmonised classification should be available for
substances of highest concern and for other substances on a case-by-case basis. Harmonised
classification should apply to all manufacturers, importers and downstream users. It also
initiates specific and additional risk mitigation measures in downstream regulations, such
as additional risk assessment, ban from consumer products.
The objective is to increase the number of harmonised classification entries, not only of
substances which are supposed to meet the existing hazard criteria but also for substances
which would meet the criteria of the possible new hazard classes over a reasonable period
of time. To also deliver increased benefits, the submitted CLH dossiers should target
identified substances where the need of a CLH dossier has been prioritised.
It is important to focus the resources of the authorities and therefore prioritise the
development of CLH dossiers on 'substances of the highest concern with regard to health
and to the environment’, in line with Recital 52 of the CLP Regulation. A first level of
prioritisation criteria is established in Article 36 of CLP, but this is not sufficient. They need
to be expanded, also in consideration of the hazard endpoints discussed in Annex 8.
212
RAC opinion on 2-EHA metal salts
213
RAC opinion on 3 lithium salts
214
Competitiveness Council on 19 February 2013 (europa.eu)
215
CLP00 and ATP01 introduced the CLHs that were adopted according to the previous legislation. Not all
ATPs introduce or revise CLHs.
269
Additional or refined criteria could also improve the pace at which hazardous substances
are identified.
Two alternative measures are assessed:
#7 Develop the discussion on prioritisation of candidate substances for CLH dossiers
at RIME+;
#8 Prioritise intentions of CLH dossiers at CARACAL level.
Aside an improved focus on the substances that most deserve a harmonised classification,
there may be ways to increase the number of CLH dossiers. This would require either a
diversion of resources from other processes or an increase in resources. However, due to
various factors (level of expertise and qualifications required for RAC members;216
transparency and independence;217
efforts to reach consensus;218
need to give stakeholders
the opportunity to provide information and comments), the number of dossiers that can be
processed by RAC is inherently limited by the complexity of opinion development, and an
increase of resources may not result in a proportional increase of adopted opinions.
The purpose of providing the Commission with the right of initiative for the submission of
CLH proposals is to speed up the CLH process and overcome the limited availability of
MSCAs’ capacity to support the process.
An additional measure, which is complementary, was considered:
#9 Allow the Commission to initiate and fund more CH dossiers, including via a mandate
to ECHA;
Under policy measure #9, the Commission would identify substances or groups of
substances considered as priorities, where MSCAs have no interest. The Commission would
either mandate ECHA to develop such CLH dossiers for those substances or contract such
tasks to consultancy. The Commission’s right of initiative would not apply to plant
protection and biocidal active substances.
SCREENING AND ASSESSMENT OF THE POTENTIAL MEASURES
Again, it is important to stress that the feasibility of the work needs to be seen in the light
of resources that will be available to ECHA versus the total amount of activities (in
particular, under REACH and CLP) that are foreseen for ECHA to carry out. In addition,
these estimates are of limited scalability, meaning that in case of a relatively high demand
(e.g. >10 CLH dossiers per year) additional overhead will need to be looked at. One can
216
‘Member States shall transmit to the Agency the names of experts with proven experience in the tasks
required by Article 77, who would be available to serve on working groups of the Committees, together with
an indication of their qualifications and specific areas of expertise’ (Article 87(2) of REACH).
217
The members of RAC should declare any conflicts of interest that affect their independence as experts (see
Articles 87(1)) and 88(3) of REACH).
218
Article 85(8) of REACH emphasises that ‘when preparing an opinion, each Committee [including RAC,
NoA] shall use its best endeavours to reach a consensus. If such a consensus cannot be reached, the opinion
shall consist of the position of the majority of members, including their grounds. The minority position(s),
including their grounds, shall also be published’.
270
also note that the CSS calls for a strengthening of the governance of the European Chemicals
Agency and an increase the sustainability of its financing.
Prioritising substances for which a CLH dossier is submitted
On prioritisation, under measure #8 ECHA would be asked to screen the registry of
intentions for new CLH proposals and to propose a prioritisation list, based on the agreed
criteria, on a regular basis. It is assumed that ECHA staff would be able to screen ten
substances per day against the agreed prioritisation criteria (e.g. hazard class, tonnage,
widespread use, etc.), including the request for additional information to the dossier
submitters and the organisation of a discussion at CARACAL level per year. These tasks
would require 0.04 FTE per year at ECHA219
. Again, it is important to note that, since the
development of the IRS, the proportion of CLH dossiers that were submitted as a follow-up
to previous activities has grown, from 23% during 2010-2015 to 68 % in 2020 (see Table
81). Therefore, the screening of CLH intentions and the request for further information is
not expected to bring significant added value as criteria are already integrated in the IRS
screening. Furthermore, the effectiveness of such screening at intention level, where part of
the work preparing for a CLH dossier has already been undertaken should be put into
question. Finally, some stakeholders, amongst them, a lot of the Member States, voiced that
such a measure would undermine the right of initiative of Member States. This would hence
not be in line with a balanced subsidiarity between Member States and the European
Commission.
Table 81. Source of CLH dossiers in 2020
Activity Proportion
REACH compliance check 44%
REACH substance evaluation 32%
RMOA 12%
Group assessment 32%
At least one activity 68%
Source: reproduced from ECHA (2021b)
Policy measure #7 derives from the same starting basis, i.e. the agreement with the MSCAs
on a set of prioritisation criteria, but instead of mandating the prioritisation to the
Commission (through ECHA), they provide for the development of guidance on the
application of the criteria by the dossier submitters. Policy measure #7 would require dossier
submitters to illustrate the application of the criteria in their CLH intentions. It is assumed
that, at first, the Commission and ECHA would provide a proposal on the prioritisation
criteria, to be discussed and agreed upon during subsequent CARACAL meetings. While
this process is not expected to entail significant costs, it may overcome the negative
feedback on Policy measure #6. Such criteria, when available, would be used to identify the
best Regulatory Management Option Analysis (RMOA) in Risk Management and
Evaluation (RIME+220
) platform. There is no additional costs entailed with this change of
criteria to be used by RIME+.
219
Six days per year to screen CLH intentions and request additional information and four days to organise a
CARACAL discussion (10 days = 0.04 FTE).
220
https://echa.europa.eu/fr/rime
271
Most respondents of the OPC and TSS supported the establishment of a prioritisation
mechanism for the development of CLH dossiers. Some stakeholders suggested that the
publication of a list of substances of concern to be prioritised could be used to stimulate
updating of self-classifications with better information. The prioritisation mechanism
should be in line with ECHA’s IRS, based on scientific arguments and focus on the hazards
that matter the most to ensure high level of protection of human health and environment.
The assessment of regulatory needs should be used to identify the best management option
prior to the CLH process, when appropriate. The process should consider the various
regulatory processes that exist and initiation of multiple, overlapping processes should be
avoided.
Some MSCAs noted that if the prioritisation mechanism were to conflict with the right of
initiative of the Member States, it would not be acceptable.
ECHA considered that ‘an informal and integrated process (with other prioritisation
activities) is very likely not only to be less resource intensive and less costly but will also
provide more coherent and consistent outcome of the overall chemicals management system
while transparency can still be safeguarded’.
Increasing the number of CLH dossiers submitted to ECHA
ECHA has estimated the resources required for the development of CLH dossiers, including
the average time and other resources required per dossier. A CLH dossier for a REACH-
regulated chemical substance can cover a number of different scenarios and dossier types.
They vary in the number of hazard classes, the complexity of the hazard classes and whether
it is a data rich substance or of a poor quality/data-lacking substance with incomplete or
missing studies inside/outside EU and of low quality/reporting with poor robust study
summaries (RSS).
The number and type of hazard classes and the type/quality of available data will together
define the quality and the complexity of the dossier preparation and together will effect the
resources required for preparing the dossier.
Again, it is important to stress that the feasibility of the work needs to be seen in the light
of resources that will be available to ECHA versus the total amount of activities (in
particular, under REACH and CLP) that are foreseen for ECHA to carry out (see above).
272
Table 82. ECHA’s estimate of resources for supporting the preparation of a complex CLH dossier
ECHA estimate for CLH
Dossier development 0.35 FTE
RAC opinion making 0.1 FTE
Support services 0.05 FTE
Total FTE 0.5
1 FTE staff costs including 19% overhead cost and infrastructure (2021
value)
€170,000
Total cost of dossier development, support services and RAC opinion
making
€85,000
Contribution to RAC organisation cost €10,000
Total (2021 value) €95,000
The ‘dossier development’ cost component has two key stages:
the collection, validation and evaluation of data for proposing the hazard classes;
and
drafting of the dossier.
ECHA considers that the first stage of collecting and assessing the data will be the most
challenging in respect of time management and experience in literature searching and data
collection as it will require the need to acquire and access proprietary data, which may
require the input of the Legal Affairs Unit regarding confidentiality and use of data. The
second stage of drafting the report is identified as being more manageable. To estimate the
resources necessary to develop a CLH dossier, ECHA has surveyed MSCAs and contractors
about the time and financial resources required for the preparation of three ‘types’ of
dossiers:
Simple: the preparation of a dossier with only one to three hazard classes and the
less complex hazard classes, such as physical hazards, irritation, or one aspect of
environmental hazards.
Medium: the preparation of a dossier with three to six hazard classes and more
complex such as CMR and Environment.
Difficult: the preparation of a dossier with seven or more hazard classes including
those of a more difficult nature.
On measure #9, the establishment of a team/unit of five FTEs in charge of preparing CLH
dossiers at ECHA could be able to develop around 225 dossiers (both simple and complex
ones) over the period 2023 – 2040 (see Table 82). This can be summed up as on average 2.5
dossiers per FTE per year.
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Table 83: Estimated number of CLH dossiers over a period of 1-5 years and 1-10 years
Work years FTE Dossiers /yr Total dossiers
prepared for
the period
Cumulative
Total of dossiers
prepared in
1- 10 yrs
Cumulative total
if an increase in
complex/
difficult dossiers
2023-2028 1 3 15
3 9 45
5 15 75
2029-2034 1 4 20 35 20-27
3 12 60 105 60-80
5 20 100 175 100-140
2035-2040 1 4 28 67
3 12 84 189
5 20 140 315
Weighted grand total (2023-2042) 250
Source: ECHA
The present value of the cost of such a team is €1.1 million. ECHA expects that over time
— e.g. three to five years — its resources would acquire experience and would therefore be
able to prepare more dossiers. However, if the new hazard classes were to be introduced in
CLP, ECHA staff may have to prepare CLH dossiers which are considered to require more
time because of their complexity, cancelling out any gain in capacity.
The development of additional CLH dossiers by ECHA would also have an impact on RAC
and its secretariat in terms of additional work. The additional burden would be lower in case
of CLH developed outside of ECHA. As RAC is currently already running at maximum
capacity, any increase of workload would have to be accompanied by a reform of RAC and
its membership to cope with additional work. For CLH dossiers, rapporteurs are RAC
members and employed as officials by a Member State. Their work is not reimbursed,
contrary to other tasks performed by RAC, such as restrictions, applications for
authorisation and Occupational exposure limits (OEL) work. Therefore, the financial costs
are almost limited to the organisation of the meetings. As another consequence, no co-opted
members can be deployed to CLH work as a consequence of the lack of reimbursement.
In addition to the resources needed to develop the CLH proposals and RAC opinion making,
there are other ECHA resources that support this work, such as the RAC secretariat, the
legal affairs unit, the library services for literature searching, HR, finance, etc. Any
additional activity also needs to make a proportionate contribution to the overall
administrative costs of running the Agency (building rent, heating, IT infrastructure, etc.).
To account for these, ECHA added 19% overhead cost, obtaining a figure of 0.15 FTE per
dossier to support the RAC opinion making and administrative overhead (ca. 0.04 FTEs for
meeting organisation, 0.06 FTEs for supporting rapporteurs in opinion drafting and 0.05 for
other support activities like HR, finance, legal support and library services for literature
searching), for a cost of €25,000 (including the 19% overhead cost) plus €10,000 in
operational costs to organise the committee meetings (assuming around 50% are remote
meetings). Assuming an average of 12.5 CLH dossiers per year (prepared by a team of five
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FTEs), over the considered period the present value of these additional costs amounts to
€0.3 million.
The Commission could provide additional funding for the preparation of CLH dossiers to
contractors, or directly to MSCAs. As noted, also for MSCAs the time to develop one CLH
dossier may vary significantly depending on the complexity of the substance (e.g.
grouping/read-across), how many hazard classes are evaluated (targeted vs. full), but also
on the experience of the staff working on the dossier. The EU27 average labour cost for
employees in professional, scientific and technical activities is €71,300. Therefore, the cost
of one CLH dossier developed by MSCAs’ staff is approximately €28,500. Considering
additional 0.15 FTE required for literature searching, HR, finance, etc., the total cost of one
CLH dossier developed by MSCAs is approximately €40,000.
External contractors have supported the preparation of CLH proposals for a number of
years, typically for CMR endpoints, but also for other hazard classes, such as acute toxicity
and STOT RE. Contractors or ECHA’s new team are usually asked to carry out the
following tasks:
 Literature search;
 Evaluation of information and drafting the CLH dossier;
 CLH dossier update after accordance check;
 Preparation and possible update of RCOM after consultation;
 Support following RAC rapporteur requests/RAC process.
The last task is mostly carried out by the dossier submitter (the supporting MS), although
contractors may be asked for some input. Usually, for CMR hazard classes, CLH dossiers
require comprehensive summaries of the available information and detailed study
descriptions of the key studies and a discussion of all relevant mechanistic, toxicokinetic or
other information crucial for the evaluation process. A detailed comparison of the data with
the CLP criteria including all arguments pro and con the proposed classification leads to
conclusions on the proposed hazard category. One of the main problems faced by
contractors is the accessibility of all relevant information from the key studies. Study
summaries in the registration dossiers are often not detailed enough to prepare sufficiently
robust study summaries for the CLH dossiers and requesting the study reports from the
registrant(s) may be time-consuming. In some cases, a separate read-across justification
document may need to be prepared as part of the CLH dossier. The average cost of
outsourcing the preparation of one CLH dossier is €33,600 (based on the 2020 contracts),
although for complex dossiers may arrive to €61,700.
In addition, ECHA and the sponsoring MSCA spend around 0.05 FTE per dossier to
organise meetings with the contractors, to contact industry about the full studies, to check
the studies, to search data available to ECHA but not to the contractors, to support the public
consultation and as a general follow-up and project management. The total cost of
outsourcing the preparation of one CLH dossier is therefore approximately €40,000 (33,600
+ 6,300 for 2x 0.05 FTE).
As noted, any increase of workload would have to be accompanied by a reform of RAC and
its membership to cope with additional work, as a mere provision of additional resources
may not take advantage of the synergies of the current setting. Such a reform needs to take
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onboard the ongoing revision of REACH, and in particular of the authorisation and
restriction mechanisms as well as the organisation and financing of ECHA foreseen in the
CSS. Since March 2021, the RAC established a Working Group to handle CLH dossiers. Its
mandate is to support the work of the rapporteurs in discussing the CLH proposals and
review opinions for efficient agreements by the plenary meetings of the RAC. The same
approach for new hazard classes or specific issues could support RAC.
Summary of the economic impacts
Administrative burden for public authorities:
Mandating the Commission to initiate CLH dossiers entails increased administrative
costs for ECHA. The present value of the cost of establishing and maintaining a team/unit
of five FTEs in charge of preparing CLH dossiers — which could be able to develop around
250 dossiers over the period 2023 – 2042 (2.5 dossiers per FTE per year) is €1.1 million
(discount rate: 3%). Considering that an ECHA staff FTE costs 170,000€, including 19%
overhead cost and infrastructure, such ECHA developed CLH dossier would cost 68,000€.
Alternatively, the Commission could provide additional funding for the preparation of CLH
dossiers to contractors, or directly to MSCAs following calls of interest. The total cost of
outsourcing to external contractors or for funding MSCAs is approximately €40,000 per
CLH dossier.
The development of additional CLH dossiers would also have an impact on RAC and its
secretariat. As RAC is currently already running at maximum capacity, any increase of
workload would have to be accompanied by a reform of RAC and its membership to cope
with additional work. Such a reform needs to be thought in the context of the ongoing
revision of REACH, and in particular of the authorisation and restriction mechanisms or the
identification of Substances of Very High Concern (SVHCs) on the ground of PBT
properties or equivalent level of concern (ED properties or PMT properties). The recently
set up Working Group for CLH has already improved the flow of CLH assessments.
Transforming the existing ECHA WGs on EDs and PBTs into WGs attached to RAC for
those properties may also help the development of RAC opinions covering those new hazard
classes.
In addition to the resources needed to develop the CLH proposals and RAC opinion making,
there are other ECHA resources that support this work, such as the RAC secretariat, the
legal affairs unit, the library services for literature searching, HR, finance, etc. These have
been estimated in 0.15 FTE per dossier, for a cost of €25,000 plus €10,000 in operational
costs. Assuming an average of 12.5 CLH dossiers per year, over the period 2023 – 2042,
the present value of these additional costs amounts to €0.3 million (discount rate: 3%).
The costs for the action of the Commission to transform the RAC opinions into a delegated
act ATP are supposed to remain equal to the baseline, for as long as the volume of RAC
opinions per year is manageable with one annual ATP. Increased consultations with
stakeholders or REACH registrants are rather small compared to the CLH development
costs.
Table 84: Costs and effectiveness of various options to develop 12.5 CLH dossiers per year (discount rate: 3%)
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Who develops
CLH dossiers
ECHA with
COM mandate
MSCAs with
COM funding
Contractors with
COM budget
Contractors
with COM
mandate
Cost per dossier
(in thousand €)
68 40 33.6 (up to 61.7) 33.6 (up to
61.7)
Additional cost
(coordination
meetings, support
provided,
contracting)**
0* 0.025 FTE MSCA
0.025 FTE ECHA
0.025 FTE
ECHA
Present value of
the costs for 250
dossiers
1.1m€ 0.7m€ 0.7m€ 0.6m€
Effectiveness
(timing, quality)
+++ ++ + ++
Note: * No additional cost foreseen for ECHA as ECHA would work independently. Reports may take place during CARACAL
meetings, with no additional cost.
** Additional costs to the Commission are not reported as the measures do not create any new tasks or trigger such additional
workload that new staff should be hired.
The introduction of a mandatory prioritisation mechanism or the improvement of the
current one under CLP for the assessment of CLH dossiers intends to increase effectiveness
and ensure the allocation of the limited resources in line with the priorities. The mechanism
would complement the prioritisation criteria listed in Article 36 of CLP. Indicatively, the
additional prioritisation criteria could be:
Hazard class and category;
Groups of substances vs single substances.
Tonnage;
Exposure (e.g. consumer exposure, widespread dispersive uses);
Divergence in self-classifications.
It should be noted that, currently, ECHA and MSCAs already prioritise substances and
groups of substances after the IRS screening stage in the informal meetings RIME+. The
prioritisation mechanism would be additional to the IRS step and would act on the CLH
intentions as expressed to the registry by the dossier submitters (MSCAs or industry). The
indication of the intention to submit a CLH dossier in ECHA’s registry of intentions could
be made obligatory (at the moment it is voluntary). This additional cost is not significant
compared to other costs and hence not reported here.
The prioritisation mechanism would consider, under measure #9, RAC capacity to process
CLH dossiers and would result in a list of prioritised CLH intentions to be discussed and
confirmed in CARACAL. Those CLH intentions not included in the prioritisation
programme would be considered of low priority and placed in a list for further consideration.
Additional costs triggered by such additional discussions in CARACAL are expected as
Member States have voiced concerns about the limitations to their right of initiative such a
measure would bring.
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ECHA would be asked to screen the registry of intentions for new CLH proposals and to
propose a prioritisation list, based on the agreed criteria, on a regular basis. It is assumed
that ECHA staff would be able to screen ten substances per day against the agreed
prioritisation criteria (e.g. hazard class, tonnage, widespread use, etc.), including the request
for additional information to the dossier submitters and the organisation of one ad-hoc
CARACAL meeting per year. These tasks would require 0.04 FTE per year.221
Again, it is
important to note that, since the development of the IRS, the proportion of CLH dossiers
that were submitted as a follow-up to previous activities has grown, from 23% during 2010-
2015 to 2016-2020. Therefore, the screening of CLH intentions and the request for further
information is not expected to require a significant amount of time.
Table 85: Source of CLH dossiers in 2020
Activity Proportion
Compliance check 44%
Substance evaluation 32%
RMOA 12%
Group assessment 32%
At least one activity 68%
Source: reproduced from ECHA (2021b)
Policy measure #8 moves from the same starting basis, i.e. the agreement with the MSCAs
on a set of prioritisation criteria, but instead of mandating the prioritisation to the
Commission (through ECHA), they provide for the development of guidance on the
application of the criteria by the dossier submitters. Dossier submitters should illustrate the
application of the criteria in their CLH intentions. It is assumed that, at first, the Commission
and ECHA would provide a proposal on the prioritisation criteria, to be discussed and agreed
upon during subsequent CARACAL meetings. While this process is not expected to entail
significant costs, it may overcome the resistance of some MSCAs, which during past
CARACAL meetings have voiced their concern over a possible conflict between the
Commission’s mandate to prioritise CLH intentions and the right of MS to initiate CLH
dossiers. ECHA considered that ‘an informal and integrated process (with other
prioritisation activities) is very likely not only to be less resource intensive and less costly
but will also provide more coherent and consistent outcome of the overall chemicals
management system while transparency can still be safeguarded’.
There are also some expected benefits from harmonising classification and providing a
level-playing field amongst manufacturers of the substances with harmonised classification
and mixtures containing such substances.
221
Six days per year to screen CLH intentions and request additional information and four days to organise
one ad-hoc CARACAL meeting (10 days = 0.04 FTE).
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Summary of the health and environmental benefits
Article 1 of CLP identifies the establishment of a list of substances with harmonised
classifications and labelling elements at the Community level as being one of the key actions
that help ensuring a high level of protection of human health and the environment.
Harmonised classifications and labelling are the triggers for risk management in much of
the downstream legislation and act therefore as one of the key cornerstones of the EU
chemicals legislative framework. As an example, harmonised classification for CMR
substances of categories 1A or 1B trigger a REACH-based ban in consumer products,
preventing exposure of those consumers to CMR substances.
There is also a positive direct impact of harmonised classification for CMR substances,
hence replacing possible less critical self-classifications. This would trigger relabelling and
possible reformulation to replace the substances at stake, further reducing the exposure of
consumers and professional users to hazardous substances. However, quantification or
qualification of this positive impact is difficult and uncertain.
Allowing the Commission to initiate CLH dossiers may speed up the process and ensure
that the substances of the highest concern are addressed in a timely manner, bringing
forward the expected benefits.
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Annex 11 - Convergence of Self-Classification
CONTEXT
The improvement of the Classification and Labelling inventory as an important tool for
notification of self-classifications is linked to other actions in the Chemicals Strategy in so
far as more accurate and reliable hazard information on chemical substances would allow
better risk management.
As to other objectives of the European Green Deal, the initiative is expected to contribute
to the zero pollution objective and to a certain extent also the circular economy. Indeed,
better knowledge of environmental hazards, if followed by risk management measures, will
allow better protection of the environment, whether at the production, use or recycling stage.
At the same time, better classification of substances is expected to trigger more appropriate
labelling, as both obligations are linked under CLP. As an example, a substance that is
classified as acutely hazardous to the aquatic environment should be labelled as ‘very toxic
to aquatic life’. It should also bear the precautionary statements ‘Avoid release to the
environment’, as well as ‘Dispose of contents to/container to…’
In terms of SDG, the envisaged measures are expected to address SDG 9 as well as,
indirectly SDG 3, 6 and 12. In general, it must be admitted that the link with these objectives
is expected to be mainly indirect, as, to grasp all potential benefits they will require
additional actions as e.g. risk management measures, labelling etc. To conclude, these
measures will be a necessary, but not a sufficient condition to meet the above mentioned
objectives.
PROBLEMS
Article 4 of CLP requires manufacturers, importers and downstream users to classify
hazardous substances or mixtures (self-classification) before placing them on the EU
market. Self-classification applies only if there is no harmonised classification and labelling,
i.e. for those hazard classes or differentiations (i.e. distinction within hazard classes
depending on the route of exposure or the nature of the effects) which are outside the scope
of that harmonisation. Duty-holders must consider all available information and evaluate
the reliability and applicability against the classification criteria for physical, human health
and environmental endpoints. They also have to review the classification of substances and
mixtures where new scientific or technical developments exist (article 15).
Article 40 of CLP requires duty-holders to notify ECHA a number of classification and
labelling data regarding their hazardous substance as well as their identity, to be included
in the Classification and Labelling Inventory. The Classification and Labelling Inventory is
maintained by ECHA and contains classification and labelling information, whether
provided directly by manufacturers or importers, or indirectly via the REACH registration
dossiers. In December 2021, the inventory contained ca. 206.000 substances, 4,500 of which
had a harmonised classification and the rest being self-classified. The Classification and
Labelling Inventory is a publicly available database that receives an average of 16,000 views
daily and supports downstream users who otherwise would depend solely on substance
safety data sheets (a sheet which is required under REACH and which contains information
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on the substance, amongst others on its classification and labelling. It has to be transmitted
throughout the supply chain to recipients, being downstream users and distributors).
Table 85 provides an overview of the information that must be notified to ECHA (Article
40) and the information that is publicly available on the Classification and Labelling
Inventory (Article 42).
Table 86. Differences between Article 40 (notified information( and Article 42 (publicly available information)
Information to be notified
to ECHA under Article 40 C&L Notification
Information published
in the Classification and Labelling Inventory
according to Article 42
Identity of notifier Not included
Identity of substance(s) EINECS name, where applicable
IUPAC name set out in Article 119(1)(a) of
REACH
Other numerical identifiers where appropriate
and available
Classification of substance(s) in accordance
with Article 13
Classification of substance(s) in accordance
with Article 13
Labelling elements specified in Article
(17)(1) points (d)-(f)
Labelling elements specified in Article (17)(1)
points (d)-(f)
Specific Concentration Limits (SCL) or M-
Factors
Not included
Where a substance has been classified in
some but not all hazard classes or
differentiations, an indication of whether this
is due to lack of data, inconclusive data, or
data which are conclusive but insufficient for
classification
Not included
The notified information is not subject to review or verification, although the information
provided via REACH, which is subject to review and verification, has been used to revise
classifications and enhance the reliability of the Inventory. In addition, Article 41 provides
that when notifications for the same substance differ, the notifiers or registrants must work
together to come to an agreed entry. Article 16 acknowledges that a substance may be
classified differently than previously submitted classifications and, if so, the reasoning for
this difference must be submitted with the notification. However, this justification does not
need to be published according to Article 42 and is not publicly available.
The problem and its scale
In terms of intervention logic, the specific problems described below fall under the more
general problem of ‘Hazardous chemicals are not comprehensively identified and
classified’. This Annex covers only the inefficiencies linked to self-classification, which are
all linked to the Classification and Labelling Inventory. Annex 10 covers the harmonised
classification process. One of the aims of the Chemicals Strategy for Sustainability is to
coordinate and simplify actions across EU chemicals legislation. This requires a review of
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the interoperability and accessibility of chemical data, including the self-classification
process and the Classification and Labelling Inventory which have been highlighted as areas
for improvement.
The Staff working document drafted in the framework of the Fitness Check of the most
relevant chemicals legislation (excluding REACH)222
highlighted the following key issues
relating to the quality of data held in the Classification and Labelling Inventory:
As self-classifications are made by the duty holders themselves, there is a possibility of
divergence in classifications across actors. In some cases, such divergence may be justified,
such as those related to differences in self-classification as a result of impurities, physical
state or differentiations. Some divergences are, however, due to differences in data used for
classification or lack of agreement between duty-holders on self-classification.
The absence of a tonnage threshold for data requirements for classification can lead to duty
holders basing their classification on different levels of toxicological data, particularly in
the absence of testing requirements. As there is no quality check, the robustness of
information provided is questionable.
As ECHA is not entitled to correct or delete self-classifications that may be incorrect or, in
the case of substances which are no longer placed on the market, obsolete, the CLI may end
up containing incorrect or irrelevant self-classifications.
Data provided by ECHA found that 78% of substances in the Classification and Labelling
Inventory have a single classification, which highlights the potential scale of the issue but
further examination of the CLI is needed to determine how many of the remaining
substances have incorrect or diverging classifications (see also Figure 72 below).
Furthermore, Amec Foster Wheeler et al.223
, investigated the divergence of classifications
of the same substance in the Classification and Labelling Inventory. Based on the responses
of companies to a stakeholder consultation questionnaire, the study found multiple reasons
for divergence. These include difficulty in interpreting study results, conflicting study
results, a lack of agreement amongst companies over how to correctly apply the
classification criteria, a need for companies to harmonise classifications based on product
ranges with similar substances, and difficulty in consistently filling in the hazard classes in
the IUCLID database.
222
Commission Staff Working Document. Fitness Check of the most relevant chemicals legislation (excluding
REACH), as well as related aspects of legislation applied to downstream industries, accompanying the
document “Report from the Commission to the European Parliament, the Council, the European Economic
and Social Committee and the Committee of the Regions. Findings of the Fitness Check of the most relevant
chemicals legislation (excluding REACH) and identified challenges, gaps and weaknesses”. SWD(2019) 199
final/2. Brussels, 18.7.2019.
223
Amec Foster Wheeler et al. (2017): A Study to gather insights on the drivers, barriers, costs and benefits
for updating REACH registration and CLP notification dossiers. Available at:
https://echa.europa.eu/documents/10162/22931011/study_drivers_and_obstacles_reach_clp_updates_en.pdf/
7b21b25e-9a11-ef05-30ce-e09a60aa204f
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The information available from previous studies combined with the analysis of 2021
Classification and Labelling Inventory data can help determine the scale of incorrect,
diverging or obsolete self-classifications in the Classification and Labelling Inventory.
The stakeholder consultation conducted for the Amec Foster Wheeler et al. study224
found
that 59% of companies using the Classification and Labelling Inventory had seen multiple
classifications for a single substance. The main reason for these differences was the lack of
agreement between companies (28%), with the existence of impurities seen as the second
most influential factor.
Most respondents to the targeted stakeholder consultation believe that the obligation of
duty-holders to come to an agreed entry in the Classification and Labelling Inventory should
be strengthened. Furthermore, there was consensus that diverging and/or erroneous self-
classifications and obsolete information in the Classification and Labelling Inventory may
hinder the ability of the CLP Regulation to protect human health and the environment.
According to the 2021 data on the Classification and Labelling Inventory provided ECHA
provided to the study team of the study underlying this Staff Working Document, 78.39%
of substances in the Classification and Labelling Inventory had a single classification and
97.64% have five or fewer classifications (Figure 72). It should be noted that a substance
can have multiple classifications for legitimate reasons, such as differences in composition
or physical form of the substance. ECHA225
lists the following justifiable reasons for
classifications in the Classification and Labelling Inventory to vary:
Different hazardous impurities, additives or ingredients might be present;
Properties such as the physical form, the pH, the flash point might be different;
Suppliers need to interpret scientific studies when they classify a chemical, and different
suppliers might reach a different conclusion, which is sometimes justifiable.
Figure 72. Percentages of substances and notifications with multiple classifications - Source: ECHA data
The divergence can be analysed further to understand the possible implications, according
to the hazards associated with substances holding more than one classification. Figure 73
points to the fact that the majority of the differences in classifications relate to health hazards
224
See footnote 3.
225
ECHA, Tips for users of Chemicals in the workplace, A short guide for users of chemicals in the workplace
on how to get the most from the classification and labelling information you receive, 2016.
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(over 80%). This suggests that the divergence in classifications in the CLI has the greatest
impact on the (mis)communication of hazards relating to human health.
Figure 73. Estimated percentage of substances with multiple classifications due to variation in the hazards
listed, in the CLI as of 30th November 2021 - Source: ECHA data
ECHA has recognised the issue of incorrect, diverging or obsolete information in the
Classification and Labelling Inventory for some time. Notifiers have been encouraged to
communicate with one another to discuss varying self-classification and labelling entries
for the same substance, in an effort to obtain consensus on the applicable self-classification
(Article 41). Furthermore, ECHA has previously attempted to facilitate these discussions
through the introduction of a Classification and Labelling platform. In 2015 ECHA
undertook a pilot project on that platform with support from a pilot project team.
Approximately 3,985 companies, that had notified 97 substances, were individually
contacted and invited to start a discussion using the C&L platform. Prior to the pilot, 25%
of all self-classified substances were found to have diverging classifications and the
platform was not actively used. It was found that although the number of notifications
decreased by close to 1,000 during the pilot, the overall aim to get duty holders to agree on
a single self-classification for a certain hazard was not achieved because the number of
classifications did not decrease. Less than five percent (5%) of the notifiers contacted used
the platform, and the number of classifications did not decrease. The platform was
discontinued as a result of lack of use and the pilot was discontinued.
The number of incorrect, diverging or obsolete self-classifications have been identified
as a key problem of the Classification and Labelling Inventory.
These classifications have a negative impact on the reliability and usefulness of information
in the Classification and Labelling Inventory and limit the effectiveness of the inventory as
a hazard communication tool. Self-classifications determine the labelling of the substances
in the supply chain and the labelling of products (which when under the scope of under CLP
are mainly mixtures) containing the substances when placed on the market. The hazard
classification of a substance also determines the appropriate risk management measures that
should be applied when using the substance, which aim to control risk by preventing, and
protecting against, harmful exposure.
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Consequently, the inclusion of incorrect, diverging (if not justified) or obsolete self-
classifications in the Classification and Labelling Inventory can lead to negative human
health and environmental impacts and a biased internal market for chemicals, because of:
 Decreased value of the Classification and Labelling Inventory as a hazard collection
and communication tool; and
 Insufficient risk management measures applied as a result of incorrect
classifications.
The problem drivers
The identified problem is a result of four underlying drivers, which represent regulatory
and/or technical failures:
No legal basis for ECHA to remove or de-emphasise inactive notifications or correct /
delete erroneous notifications and inability for notifiers to remove obsolete
Classification and Labelling entries. This driver relates to the lack of a process to remove
incorrect or inactive notifications, but they differ with respect to the party involved. Articles
15 and 40 of the CLP Regulation place legal obligations on notifiers to update their
notification(s) whenever they become aware of new and reliable information which changes
the classification and labelling of their substance(s). Notifiers can inform ECHA if the
manufacture or import of the substance has ceased. This will change the notification to
“Inactive” but notifiers are not entitled to themselves modify/remove their notification from
the inventory as it is ECHA which maintains the Classification and Labelling Inventory.
The inventory is automatically updated when a notifier submits data to ECHA. There is no
legal basis for ECHA to correct or delete obvious mistakes as it is not expected from ECHA
to know the exact classification of each substance under self-classification. There is also no
legal basis for ECHA to remove entries by companies which no longer exist or for
substances which are no longer placed on the market (especially below 1t/y), or to contact
notifiers/registrants to initiate these corrections. Finally there is also no obligation for the
manufacturer/importer to check the quality of the information being notified. Feedback
received on CARACAL Document CA/77/2020 on the improvement and re-design of the
CLP inventory suggested that multiple classifications for the same substances are to a
significant extent caused by the inability to remove classification and labelling entries for
substances that are no longer of interest to a notifier. However, when a notifier indicates to
cease manufacture/import, the C&L is removed from the public inventory (so in effect it
appears as removed).
Shortcomings in ECHA’s IT tools for Classification and Labelling notifications,
leading to high administrative costs and burden for companies. Notifications to the
Classification and Labelling Inventory must be submitted electronically, either through the
REACH-IT portal or IUCLID. Previously, the bulk notification tool (Bulk XML) could be
used to submit bulk notifications, but this method has recently been replaced with IUCLID
cloud and a soon to be released system-to-system platform. The choice of which tool is used
to submit a notification to the Classification and Labelling Inventory depends on whether
you have a substance with multiple constituents, if a notifier wants to keep the IUPAC226
name confidential when submitting the notification, or the number of substances to be
226
IUPAC: International Union of Pure and Applied Chemistry.
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notified. A report on the review of ECHA found shortcomings with ECHA’s IT tools (Amec
Foster Wheeler et al., 2017227
), which may act as a deterrent for companies when it comes
to updating their Classification and Labelling Inventory notifications, particularly for SMEs.
These included:
Frequent IUCLID updates, leading to adaptation costs primarily due to
training and increased administrative burdens for companies;
Lengthy and sometimes too complex guidance for IUCLID;
REACH-IT not being accessible on weekends and Finnish public holidays;
IT tools not translated into every EU language; and
Complexity and lack of user-friendliness of the software, particularly IUCLID, leading to
time consuming processes and the need for SMEs to use external consultants.
However, it needs to be noted that the three first shortcomings listed above have meanwhile
been addressed by ECHA’s IUCLID cloud.
Lack of transparency in the Classification and Labelling Inventory regarding the
identity of notifiers preventing communication between notifiers of the same
substance. The public Classification and Labelling Inventory does not publish the identity
of notifiers, and therefore notifiers are unable to identify who has submitted classifications
and why they are possibly differing from their own. This lack of transparency regarding the
notifier identity acts as a barrier for discussions amongst notifiers. However, ECHA figures
(see above) show that the problem is not as huge as originally suspected, especially as many
notifiers are part of a ‘group’ (see next para.) and hence they know the group members’
identity. The notifier that submits a notification with a group of companies has to upload a
file with the names of the companies, meaning it knows the name of the companies in that
group.
No compulsory legal requirement for notifiers to come to an agreement on self-
classifications. Article 41 of CLP states that for notifications for the same substances “the
notifiers and registrants shall make every effort to come to an agreed entry to be included
in the inventory”. However, there is no legal obligation for notifiers and registrants to come
to an agreement. Data provided by ECHA on the Classification and Labelling Inventory
highlighted that collaboration is already happening to a certain extent. Around one third of
notifications are coming from groups of manufacturers and importers, with an average of
44 manufacturers/importers per group. This leaves around two thirds of notifications
coming from individuals who are likely to be self-classifying their substances in isolation.
However, based on the high usage of the Classification and Labelling Inventory, many are
likely to be classifying similarly to already existing notifiers, even if not actively discussing
with them. So while the Classification and Labelling Inventory is unlikely to bring existing
notifiers to change what they already notified, it is likely to serve as a source for new
notifiers. Moreover, some of ECHA’s submission tools (online dossier tool, subsequently
IUCLID cloud) suggest existing classifications when submitting a notification for a
substance already in the Classification and Labelling Inventory.
227
Amec Foster Wheeler et al., A Study to gather insights on the drivers, barriers, costs and benefits for
updating REACH registration and CLP notification dossiers, 2017, Available at:
https://echa.europa.eu/documents/10162/22931011/study_drivers_and_obstacles_reach_clp_updates_en.pdf/
7b21b25e-9a11-ef05-30ce-e09a60aa204f .
286
It has been noted by ECHA that the Classification and Labelling Inventory primarily
provides transparency on how substances on the EU market have been self-classified by
companies and it is not a tool that creates harmonisation after companies have notified their
classifications to the inventory. There is no incentive for agreeing on classifications after
notifications are submitted to the inventory.
Stakeholders’ views228
Stakeholder mostly approached the problems from the perspective of actions or measures
that could be taken to tackle them. Therefore, most responses were not descriptions of the
problems as perceived by the respondents, but rather reactions to potential actions or
measures.
With regards to Classification and Labelling Inventory, few reactions were received in
position papers and open text responses both in the OPC and Targeted Stakeholders Survey
that may indicate less interest of the respondents in this problem. Furthermore, the Targeted
Stakeholders Survey respondents (who mostly represented business entities) explicitly
stated in their open text comments that they do not see any significant problems in
Classification and Labelling Inventory, although acknowledged that the Inventory contains
obsolete information and errors and self-classification of the same substance/mixture may
diverge. However, the latter could be often justified. Similarly, the interview respondents
pointed to the quality of CLI Classification and Labelling Inventory information as well as
diverging self-classifications as problems, although as reported such problems did not have
any significant effect on stakeholders.
Very few instances of written feedback following the CARACAL meeting on self-
classification has been available mostly from the observers.
The baseline
As of 30th November 2021, 751,436 notifications have been submitted to the Classification
and Labelling Inventory on 205,903 substances, the majority coming from C&L
notifications (656,741) and the remainder coming from REACH Registrations (94,695).
Most substances (89%) notified to the Classification and Labelling Inventory originate
exclusively from CLP notifications – e.g. due to tonnage thresholds or exemptions -, with
11%229
originating from REACH registrations.
Actual notification submitters (excluding group members) amount to 22,745 legal entities,
of which 14,888 from REACH Registrations and 12,244 from CLP notifications. Around
11,055 actual notification submitters are SMEs (48.6% of the total).
A single Classification and Labelling notification, described as a granular C&L notification,
contains a combination of the following:
 Substance;
228
See also Annex IV.
229
According to ECHA, 2% of substances in the CLI get their data from REACH registrations only. 9% of
substances get their data both from C&L notifications and REACH registrations (the logical explanation is
that some companies are below 1 tonne).
287
 Substance variant (e.g. physical state / form; chemical hydration; composition with
an impurity / additive etc);
 Classification;
 Labelling;
 Legal entity.
Classification and Labelling notifications can be submitted by one legal entity on behalf of
a group of manufacturers and importers. For example, the notification submitted on behalf
of 50 group members would resolve into 50 granular Classification and Labelling
notifications, and if the group notification contained two substance variants, it would resolve
into 100 granular notifications. When the number of granular notifications is taken into
account, over 10 million unique notifications have been submitted to the Classification and
Labelling Inventory, which come mainly from expanding the group notifications into their
constituent Classification and Labelling notifications from the different group members.
Data provided by ECHA to the study team of the study underlying this Staff Working
Document shows that on average a group notification contains 44 group members.
The large number of granular Classification and Labelling notifications that come from
group notifications demonstrates that a significant amount of collaboration between duty-
holders is already taking place to agree on a single classification, which is illustrated in the
graphics below. Figure 75 shows the level of agreement for different classifications and
labelling combination for substances in the Classification and Labelling Inventory that have
5 or fewer distinct classifications and labelling combinations.
288
Figure 75: Level of consensus based on submissions by individual notifiers and notifiers representing group
notifications - Source: ECHA data
Figure 76 shows that if the agreement within group notifications is taken into account there
is a much higher level of consensus. It shows divergence caused by differences in
classification only, rather than divergence caused by different combinations of classification
and labelling, as substances with the same classification can have two distinct labelling
blocks.
Figure 76: Level of consensus factoring in manufactturers/importers groups - Source: ECHA data
289
However, the level of convergence within group notifications is not currently displayed in
the existing data structure of the Classification and Labelling Inventory. The summaries of
notified classification and labelling entries are ordered by number of notifiers, but this only
counts M/I groups as one notifier.
As highlighted above 78% of substances and 31% of notifications are aligned with a single
classification and divergence amongst the remaining 22% of substances and 69% of
notifications can be due to legitimate reasons, such as differences in physical form, presence
of impurities etc. Moreover, although sixty-nine percent (69%) of notifications diverge, this
figure is reduced to 23% once the agreement within group notifications is taken into account
- although this is not visible in the Classification and Labelling Inventory public portal.
This means that, when looking at the level of alignment in granular Classification and
Labelling notifications, which considers agreement within manufacturers/importers groups,
77% of the 10 million granular C&L notifications agree on a classification.
The data shows that classification divergence affects around 22% of notified substances.
ECHA and the European Commission initiated a redesign of the Classification and
Labelling Inventory in 2019. The aim is to improve how data are displayed, structured and
made available in the Inventory, in order to bring additional value and improve its ease of
use. Discussions held during CARACAL meetings highlighted the difficulties around
locating the relevant data from the inventory when small discrepancies lead to multiple
entries. CARACAL members noted that the current format highlights the differences and
does not focus on the similarities. The redesign of the Inventory is expected to streamline
the data set, enhance the data available and provide tools to tailor the results.
The suggested improvements are based on years of operational feedback from MSCAs,
users, and Classification and Labelling experts, and work done on other disseminated
datasets. The improvements would focus on:
 Improving structure and display of data to make consensus Classification and
Labelling data more prominent – the ability to use filtering logic is envisaged to
assist with removing erroneous entries and corrupt data230
regularly associated with
group self-classifications;
 Clarifying the source of divergence – this would involve processing and
publishing data on the physical form of a substance and the existence of impurities.
This granularity could help users understand why classifications legitimately differ
from one another;
 Publication of notifier names to encourage convergence; and
 Revising data access formats (download, Application Programming Interface).
230
According to ECHA the data corruptions mostly came from the now discontinued Bulk XML tool, and are
not related with the groups (even if also groups have notified with this tool). ECHA is undertaking a project
to resolve the corruptions as far as possible; results will be available in the new platform.
290
It has also been proposed to add the functionality of a “notifiers dashboard” for companies
to have an overview of their notifications, the possibility to access them, do modifications
in bulk and update when necessary. Another proposal was to eliminate a notification once
the notifier has submitted a REACH dossier, as the C&L of the dossier must always have
precedence. The latter measure is already in place in the meantime.
The redesigned inventory was initially planned to become operational in 2022. However,
ECHA experienced a number of problems with the current dissemination platform, which
impacted on the data within the CLI, with instances of some of the publicly available data
disappearing. This meant that ECHA has had to delay its roadmap for improving the CLI to
focus its resources on “life support” of the current platform to keep it operational. ECHA is
currently looking to develop a new data availability solution to host future dissemination
activities. Work has begun to scope out the construction of this solution, as an architecture
study is currently underway to determine how the new dissemination platform that will be
used to host the redesigned CLI will be built. According to ECHA the cost of the redesign
is dependent on the findings of this study, which is due for completion in Q3 2022. The
resources for the redesign are currently coming out of the ECHA budget. The first version
of the new dissemination platform aiming to be made available in 2023, therefore, the
redesign of the CLI is expected to be delayed until at least 2023.
In general, it is expected that the new platform will be more stable, more easily maintained
(e.g. towards changes in data formats), have improved data access methods (not only visual,
but also computer methods). Data flows in the new platform will also be more generic. E.g.
identity of submitters will be a standard information element for any type of dossier. Hence,
the decision to publish it (for any type of dossier, but also C&L) should not require
significant new development in the future platform, as it would have required in the current
one.
Specific requirements for C&L data need to be identified, but for example, the following
idea exists beyond visually promoting the most common C&L and explaining reasons for
divergence:
Making available the most common Classification and Labelling to new/existing submitters
preparing dossiers in the various submission tools, in the final data format. This promotes
harmonisation, reduces burden of submission, reduces mistakes by avoiding retyping.
Although that initiative will not directly address the drivers of diverging classifications in
the CLI, it aims to provide transparency on the reasons for divergence and aims to make
consensus classifications more prominent, which is expected to allow users to find the most
relevant and accurate data with ease. The redesign is also expected to display agreement
within group notifications. When considering the outcome of the changes in the redesign, if
the changes are made as described, it is expected that the additional information and the
prioritising of consensus classifications will reduce the impacts of the problem. These
changes will not necessarily address the source of the divergence. However, the changes, if
implemented as described, could help users prioritise the information in the CLI and
subsequently find the most relevant data reducing the impact of the incorrect classifications.
The outcome of the redesign cannot be fully assessed currently, as, based on discussion at
CARACAL, the redesigned Inventory is expected to be launched in 2023.
While incorrect or diverging self-classifications may still be notified in the coming years,
the redesign of the Classification and Labelling Inventory is expected to emphasise
291
converging self-classifications as described above and classifications derived from REACH
registration dossiers. It will highlight the justifications provided for diverging
classifications, promote convergence and ease access to the inventory by revising the IT
features. All of these improvements are expected to positively address some of the issues
discussed so far, although this is dependent on notifier’s engagement with the platform231
.
If notifiers make use of the new features it can be predicted that these changes will aid the
improvement of the CLI data. The redesign will not address the lack of legal basis for ECHA
to remove incorrect or obsolete notifications so this issue will remain, even though the
redesign will de-emphasise these notifications. In addition, without stricter enforcement of
the requirement for notifiers to come to an agreement on self-classifications of the same
substance it is unlikely the increased usability of the CLI will reduce this issue of
divergence. Although the convergence will be promoted by the need to provide details and
justifications, further encouragement – e.g. enforcement actions - may be required.
In addition the EU platform which the Commission plans to develop is expected to contain
different inventories, such as the CLI. It is expected that further adaptation of the CLI will
be needed to ensure its optimal integration in the EU platform.
POSSIBLE POLICY MEASURES
Figure 77 below is an excerpt from a study performed for ECHA in 2017232
showing which
were the respondents’ preferred ways to solve the issue of diverging classifications.
Measures # 3 (Require notifiers with classifications that diverge from the entry agreed by
most notifiers to update their notifications with a justification for any divergence) and
measure #4 (make notifiers name public) try to address the most frequently suggested way
forward. Indeed, measure #4 aims to increase transparency and #3 increases the clarity of
how the information is displayed.
231
If some notifiers do not use the new CLI when preparing their notifications or notification updates, but
derive their information from other sources, then for their notifications it will not matter however much ECHA
improves the prominence of most common C&L, or make available the data in a ready-to-use format etc.
232
Amec, Foster, Wheeler, 2017, “A study to gather insights on the drivers, barriers, costs and benefits for
updating REACH registration dossiers and CLP notification dossiers”, p.46.
292
Figure 77: Feedback from stakeholders on the best options to solve the issue of diverging classification
ECHA has implemented a number of measures to modernise submission systems, make
inventory data easier to understand and facilitate the re-use of data both by IT
improvements. The simplified submission systems should benefit especially less
experienced notifiers. Further improvements will be done, especially to display more
prominently certain classifications (e.g. those that have a harmonised classification and
labelling, those which are supported by a group or that have been updated in REACH
registration dossiers). Ongoing or planned improvements also relate to mentioning elements
allowing to better understand the reason for divergence (e.g. data sources REACH/CLP,
differences related impurity, grade, form). Some of these improvements are mentioned in
Table 86 below (without bold) but they are not subject to this impact assessment as they
belong to the dynamic baseline.
293
Table 87: Overview of possible measures (the measures not in bold belong to the baseline)
The C&L
Inventory
contains
incorrect,
diverging or
obsolete
information on
self-
classification,
that cannot be
removed by
ECHA,
impacting the
reliability and
usefulness of
information in
the C&L
Inventory
ECHA has no legal
mandate to remove
inactive
notifications or
correct / delete
erroneous
notifications
#6 Require notifiers to
validate/update entries in the C&L
Inventory every 2 year(s)
PO1-b
Improving the
CLI and
promoting
convergence of
self-
classifications
Redesign the CLI to emphasise up to
date C&L notifications and aligned
classifications
#5 Swift notification updates
Require notification of updated
self-classifications within a certain
deadline after new pieces of
evidence are available
Shortcomings in
ECHA’s IT tools for
C&L notifications
Add a notifier dashboard to give
companies an overview of their
notifications and allow ease of access
and update. Extend the ‘cease of
manufacture and import’ functionality
for registrants in REACH-IT to C&L
notifiers
Ensure that when a C&L notifier
submits a registration dossier, the
C&L data provided in the registration
dossier replaces any earlier data
provided in a C&L notification
Notifiers’ identities
are not published
#4 Publish contact information for
submitted classifications so that
notifiers can contact the notifiers of
the same substances
Notifiers are not
required to come to
an agreement on
self-classifications
#3 Require notifiers with
classifications that diverge from the
entry agreed by most notifiers to
update their notifications with a
justification for any divergence
294
Table 88: Impact assessed measures
#6 Require notifiers to
validate/update entries in
the C&L Inventory every 2
year(s)
Hard,
legally
binding
rules
The Commission to amend Article 40 of CLP to
introduce the requirement for notification update.
Notifiers are the only actors that can guarantee
their notifications stay up to date. The requirement
should come into force with the launching of the
redesigned CLI platform.
#4 Publish contact
information for submitted
classifications so that
notifiers can contact the
notifiers of the same
substances
Hard,
legally
binding
rules
The Commission to amend Article 42 of CLP.
#3 Require notifiers with
classifications that diverge
from the entry agreed by
most notifiers to update
their notifications with a
justification for any
divergence
Hard,
legally
binding
rules
The Commission to amend Article 41 of CLP to
require justification of diverging classifications
from classifications backed up by REACH
registration dossiers or from classifications
notified the most. The requirement should come
into force with the launching of the redesigned
CLI platform.
#5 Swift notification
updates Require notification
of updated self-
classifications within a
certain deadline after new
pieces of evidence are
available
Hard,
legally
binding
rules
The Commission to amend Article 40(2) to add a
deadline after which an update is required (from
the moment
ECHA has implemented a number of measures to modernise submission systems, make
inventory data easier to understand and facilitate the re-use of data both by IT
improvements. The simplified submission systems should benefit especially less
experienced notifiers. Further improvements will be done, especially to display more
prominently certain classifications (e.g. those that have a harmonised classification and
labelling, those which are supported by a group or that have been updated in REACH
registration dossiers). Ongoing or planned improvements also relate to mentioning elements
allowing to better understand the reason for divergence (e.g. data sources REACH/CLP,
differences related impurity, grade, form). Some of these improvements are mentioned in
Table 86 above (without bold) but they are not subject to this impact assessment as they
belong to the dynamic baseline.
295
SCREENING AND ASSESSMENT OF THE POTENTIAL MEASURES
Economic Impact
#4 Publication of the identity of notifiers (i.e. company names and contact details) in the
CLI.
One of the policy options to address the lack of convergence of self-classifications analysed
below belongs to the measures initially envisaged by the Commission. The Commission at
the time, had proposed to systematically publicise the identity of notifiers and make them
visible to anyone consulting the C&L inventory. However, before implementing such
measure, it was decided to assess its potential impacts in order to check whether it would
be relevant to maintain the measure as planned or to modify it and if a change in the legal
provisions was necessary – inter alia as ECHA was not planning to implement that measure
any more. Hence, though strictly speaking one could argue that this measure belongs to the
baseline, it is analysed to check whether this is the best option to address the problem, also
in view of other planned new developments in ECHA’s tasks.
Table 88 below provides an overview of the costs linked to the measure.
Table 89: Policy measure #4 Publication of the identity of notifiers (i.e. company names and
contact details) in the CLI
Impact
Category
Impact Positive or
negative
Direct or
indirect
Monetised
impacts
One off or
recurrent
PV
Annualised
impacts
Administr
ative
burdens on
business
Cost of
updating
contact
details
(o) Direct Negligible One off Negligible
Cost of
submitting
confidential
ity requests
(-) Direct
Total cost
of €270,000
One off €18,148
Cost of
navigating
the CLI
(+) Indirect
Cost saving
of
€1,750,000
(€1,300,00
for LEs and
€450,000
for SMEs)
Recurrent
(annual)
€2,352,550
(€1,747,608
for LEs and
€362,965
for SMEs)
Positions
of SMEs
Increased
ability to
collaborate
(+) Indirect
See
Administrat
ive Burdens
on Business
Recurrent -
Sectoral
competitiv
eness,
trade and
investment
flows
Increased
visibility of
company
activities
(o) Indirect
Not
quantified
Recurrent -
Public
Authorities
Cost of
reviewing
(o) Direct
Not
quantified
Recurrent -
296
Table 89: Policy measure #4 Publication of the identity of notifiers (i.e. company names and
contact details) in the CLI
Impact
Category
Impact Positive or
negative
Direct or
indirect
Monetised
impacts
One off or
recurrent
PV
Annualised
impacts
confidential
ity requests
Administrative Costs
Cost of updating contact details
Policy measure #4 requires notifiers of single notifications or lead notifiers of group
notifications to update their notifications with their company name and contact details.
However, these details are already included in the submission when creating a user account
and therefore no time or costs are required for the updating of the notifications.
Cost of submitting confidentiality requests
Article 77(2)(e) of REACH tasks ECHA with making the information identified in Article
119(1) and (2) in the database(s) publicly available, free of charge, and over the Internet.
The same Article 77(2)(e) explicitly mentions the Classification and Labelling Inventory.I
as one of the databases concerned233
. On this basis, the Commission Services’ concluded
that the identity of notifiers can be made public234
. However, Article 77(2) also allows
notifiers to the Classification and Labelling Inventory. to have the opportunity to make
confidentiality claims if they are considered justified.
Based on discussions at the meeting of the Competent Authorities on REACH and CLP
expert group235
, confidentiality requests are expected for around 1% of C&L notifications,
based on the rates of claiming confidentiality under REACH. Applying this percentage to
the number of notifications received via Classification and Labelling notification (656,741),
rather than via REACH registration dossiers (94,695), this would equate to roughly 6,600
confidentiality requests. This percentage is not applied to notifications from REACH
Registration dossiers because according to ECHA confidentiality claims made under
REACH Registrations would carry over to the Classification and Labelling Inventory.
Under REACH, confidentiality requests must be submitted with a well-substantiated
justification for why information should be confidential. Possible justifications for Classifi-
cation and Labelling notifications can include:
Natural person
Product and Process Oriented Research and Development (PPORD) activities
Scientific R&D activities
Non-hazardous substance
Revealing company strategic information
233
See: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A32006R1907
234
European Commission, 2020, 37th Meeting of Competent Authorities for REACH and CLP (CARACAL)
CA/77/2020
235
See Footnote 234.
297
Revealing the formulation of products
Revealing involvement in specialty chemicals production
Breaching a non-disclosure agreement
To provide a well-substantiated justification, it is assumed that confidentiality requests will
need to be individual to each substance, with limited possibility of grouping substances. The
study team for the study underlying this Staff working document considered a reasoned
estimate of the time to provide a justification to be one hour. Assuming an hourly rate of
€41.126, this leads to a total cost among registrants of approximately €270,000 (6,600 x
€41.126 = €271,432).
It should be noted that the number of confidentiality requests under REACH are low, partly
because of the significant fee for claiming confidentiality236
and partly because of the
experience companies have in that confidentiality requests are only accepted if they are well
substantiated (20-25% of confidentiality requests overall are not accepted, although the
success rate is higher for requests on company names). Therefore, there is the possibility
that the rates of claiming confidentiality may be higher for Classification and Labelling
notifications.
Cost of navigating the Classification and Labelling Inventory.
Each of the three policy measures under consideration aim to address the problem of
incorrect, diverging or obsolete information on self-classification in the CLI, in order to
make data in the Inventory easier to understand and use. Therefore, an expected benefit to
the conduct of business is a reduction in the time taken by Inventory users to find the most
relevant and reliable data. The time saving is expected to be greatest amongst inexperienced
users, such as SMEs.
Based on stakeholder feedback, the 2017 Fitness Check237
found 36% of manufacturers,
formulators, distributors and importers use the Classification and Labelling Inventory
multiple times a week. On average, it was estimated that a large company spends 2 hours
per month (24 hours per year) checking the inventory, with a cost of €987 per year (based
on an hourly rate of €41.126). SMEs were estimated to spend half the time, and thus incur
half the cost (€493.50 per year).
The reduction in time spent using the CLI Classification and Labelling Inventory is
dependent on the effectiveness of policy measure #4 in addressing the problem of incorrect,
diverging or obsolete information on self-classification in the inventory . Policy measure #4
does not have a direct impact on the improvement of self-classification in the inventory, as
it relies on companies using published contact details to collaborate. Previous initiatives
aimed at promoting collaboration have also achieved limited results. Therefore, the cost
saving is expected to be small. A small time saving of about 10% could be possible which
would equate to a cost saving of €98.7 per large company and €49.3 per SME. Multiplying
236
The fee for claiming confidentiality on legal identity information in an SDS ranges between €163 for
individual submissions for micro enterprises to €3,261 for individual submissions for large enterprises. See:
https://eur-lex.europa.eu/legal-content/en/TXT/HTML/?uri=CELEX:02008R0340-20180715&from=EN
237
Study on the regulatory fitness of the legislative framework governing the risk management of chemicals
(excluding REACH), in particular the CLP Regulation and related legislation, Ref. Ares(2017)1390364 -
16/03/2017.
298
these figures by the total number of large companies and SMEs gives total annual cost
saving of approximately €1,300,000 (€98.70 x 13,485 = €1,330,970) for large companies,
€450,000 (€49.35 x 9,260 = €456,518) for SMEs, and a total annual cost saving to all
companies of €1,750,000.
SMEs
The costs associated with self-classifications are often high and unaffordable to SMEs,
meaning they rely on classification done by larger companies - when they exist. If the names
of notifiers are displayed it will be easier for SMEs to contact larger companies – which
may be interesting if they have a very similar or same substance. Also for SMES which are
often users or importers of mixtures it is beneficial to have more certainty regarding the
hazard of the substances – through the fact that notifiers can more easily get into contact
with each other – they will use in the mixture as this will ease the classification of their
mixture.
Sectoral competitiveness, trade and investment flows
The additional information and transparency on the identity of notifiers is expected to aid
competitiveness of EU industry, particularly the competitiveness of SMEs. However, the
impact of the measure on its own, is expected to be weak, as its effect relies on companies
using published contact details to collaborate. Previous initiatives aimed at promoting
collaboration amongst duty holders have also produced very limited results. On the other
hand it is not excluded that the measure acts as an incentive for notifiers to contact each
other and come to an agreed entry. Moreover, there was agreement to that proposed measure
by the Competent Authorities on REACH and CLP expert group, except for substances used
for product and process orientated research and development (PPORD).
Public Authority Costs
Cost of reviewing confidentiality requests
At the 37th Competent Authorities for REACH and CLP expert group meeting it was
explained that there are no fees for confidentiality requests in C&L notifications, and
therefore no resources are expected for ECHA to assess the requests. Also, given the high
number of requests that are predicted, it would not be feasible to manually assess them.
Therefore, the proposed approach was to provisionally accept all confidentiality requests
made, with possible follow-up actions to be agreed later, as required. IT screenings or spot
checks would be considered by ECHA as mechanisms to avoid or spot any misconduct. The
system to be put in place for updating Classification and Labelling notifications, would
recommend that notifiers make confidentiality requests only where needed and would
highlight the information needed to justify a request, and which types of reasons are
considered invalid. ECHA did not plan to hire additional staff if it were to perform such
tasks. Hence, the measure would require ECHA resources to be diverted from other tasks.
As the proposed measure was generally supported by the Competent Authorities on REACH
and CLP expert group and because the legal text is not clear on that point, such measure
would require the legal text to be clarified. The measure would allow ECHA to disclose the
identity of notifiers, either generally or upon request, subject to a duly motivated
confidentiality request by a notifier.
299
A summary of the costs and benefits of policy measure #4 are provided below.
Summary of cost and benefits of policy measure #4
Costs - businesses
Total one-off costs over a 20-year period €270,000
Recurring costs every 1 year
Total recurring costs over a 20-year period
PV of one-off costs (20 years; 3%) €362,965
PV of one-off costs (20 years; 3%) (annualized) €18,148
PV of recurring costs (20 years; 3%)
Total PV – costs - businesses
Costs – public authorities
Total one-off costs over a 20-year period
Recurring costs every 1 year
Total recurring costs over a 20-year period
PV of one-off costs (20 years; 3%)
PV of recurring costs (20 years; 3%)
Total PV – costs – public authorities
Total PV cost of policy measure #4 €362,965
Benefits (cost savings) - businesses €33,250,000
PV benefits - businesses €44,698,446
Benefits (cost savings) – public authorities
PV – benefits – public authorities
Benefits - society
PV - benefits - society
Total OV - benefits
Net Present Value - NPV (PV benefits – PV costs) €44,335,481
A summary of the present value (3% discount) costs and benefits of policy measure #4 are
provided below.
Summary of costs and benefits (PV; 20 years; 3%) of policy measure #4 by type
Costs
Businesses Administrations Society
Direct adjustment
costs
Direct
administrative costs
€362,965
Direct regulatory
fees and charges
Indirect costs
Benefits
Description Businesses Administrations Society
Direct benefits
300
Direct cost savings €44,698,446
Indirect benefits
#6 Require notifiers to validate/update entries in the C&L Inventory every 2 year(s)
Another measure that has been considered as possibly improving the data submitted to the
Classification and Labelling Inventory is to oblige notifiers to update their notification on
a regular basis, e.g. every two years. They would have to look at the data they had submitted
before and update, correct or confirm any information from their previous notification.
However, in the view of ECHA, this would not trigger an improvement as Classification
and Labelling notifications usually do not need regular updates and having permanent
updates would not allow to have a stable version of the Classification and Labelling
Inventory .
The costs of such measure have been analysed and are provided hereinafter. The benefits
are analysed in a separate heading, together with the benefits of the other options.
Table 90: #6 Require notifiers to validate/update entries in the C&L Inventory every 2 year(s)
Impact
Category
Impact Positive
(+);
negativ
e (-);
neutral
(o)
Direct
or
indirect
Monetised
impacts
One off or recurrent PV
annualised
impacts
Administrative
burdens on
business
Cost of
checking
notifications
(-) Direct Total cost of
€4,900,000
Recurrent
(biannual)
€3,293,570
Cost of re-
classification
(-) Direct Total cost of
€10,400,000 -
€20,800,000
Total cost of
€1,040,00 -
€2,080,000
One-off
Recurrent (biannual
)
€699,044 -
€1,398,087
Cost of
updating and
distributing
revised Safety
Data Sheet
(SDS)
(-) Indirect Total cost of
€17,900,000 -
€34,800,000
Total cost of-
€1,790,000 -
€3,480,000
One-off
Recurrent (biannual
)
€1,196,440
-
€2,406,322
Cost of re-
labelling in line
with re-
classification
(-) Indirect Total cost of
€102,000,000
-
€200,000,000
One-off €6,856,002
-
€13,443,14
2
301
Total cost of
€10,200,000 -
€20,000,000
Recurrent
(biannual)
Cost of
navigating the
CLI
(+)
Indirect
Cost saving of
€8,950,000
(€2,300,000
for SMEs)
Recurrent (annual)
from year 2
€12,031,61
2
(€3,091,923
for SMEs)
Positions of
SMEs
Additional
burden on
SMEs
(-) Indirect See
Administrativ
e Burdens on
Business
Recurrent
-
Sectoral
competitiveness
, trade and
investment
flows
Impact on
competitivenes
s of businesses
(+) Indirect Not
quantified
Recurrent
-
Public
Authorities
The reviewing
of C&L
notifications
(o) Direct Not
quantified
Recurrent
-
Administrative Costs
Cost of checking notifications
Policy measure #6 requires notifiers to check their notification submissions to the CLI to
verify that their self-classifications are correct and up to date. If any self-classification is
incorrect or not up to date, either because new adequate and reliable scientific or technical
information has become available that affects the classification, or if the notifier no longer
manufactures, imports or uses the substance which has been notified, then action will need
to be taken to update the notification. This action will either involve re-classification of the
substance (see next paragraph) or removal of the notification.
This policy measure will require every notification in the Classification and Labelling
Inventory to be validated by the notifier or the lead notifier of a group notification and
updated if necessary (the updating costs are presented in the next paragraph). Data on the
Classification and Labelling Inventory that was provided by ECHA for the purpose of the
study underlying this Staff Working Document, shows that as of 30th November 2021, there
were 751,436 notifications in the Inventory. Some 13% of the overall notifications come
directly via REACH registration dossiers. REACH registrants would then update those
94,965 notifications via REACH. Hence they are out of the scope of measure #6 (and
measure #5 as well).
Therefore, a total of 656,741 notifications were submitted to the C&L Inventory directly
from 12,244 notifiers. The data provided by ECHA also provides a breakdown of the
number of C&L notifications from large companies (405,713) and SMEs (251,028). This
gives an average of 54 notifications per notifier. Dividing these figures by the number of
large notifiers (5,931) and SME notifiers (6,313) gives an average number of 68
notifications submitted by each large company and 40 notifications submitted by each SME.
302
The 2017 Fitness Check238
of CLP estimated the average time to submit lower complexity
notifications to the Classification and Labelling Inventory was 0.18hrs, which equates to
roughly 11 minutes. This was considered a reasonable proxy of the time that would be
needed to validate a notification, which does not require any update. In line with the Fitness
Check, an hourly rate of €41.126 has been assumed for staff involved in compliance
activities. This equates to a cost per notification of €7.40, and an average cost of €400 (€7.40
x 54 notifications) per company, €503 (€7.40 x 68 notifications) per large company, and
€296 per SME (€7.40 x 40 notifications). The total biennial cost to large companies would
be approximately €3,000,000 (€503 x 5,931 = €2,983,293), €1,900,000 (€296 x 6,313 =
1,868,648) to SMEs and a total biennial cost to all companies of approximately €4,900,000.
This cost is based on the assumption that all checks confirm the existing classification.
Where a notification should be updated, costs below apply.
Cost of re-classification
The 2017 Fitness Check estimates the average cost of undertaking re-classification activities
to be €400, based on feedback from industry stakeholders. This estimate excludes the cost
of any associated testing.
Data on the Classification and Labelling Inventory that was provided by ECHA to the study
team for the study underlying this Staff Working Document, shows that 3-5% of the 10,000
REACH Registration dossiers that are updated each year provide a change in classification
and labelling as one of the reasons for update. The statistics rely purely on the declaration
of the registrant as regards the reason for update, as no validation is made by ECHA to
determine whether the classification was actually changed. Therefore, there is a degree of
uncertainty in this figure.
It is assumed that a similar percentage would apply to all notifications submitted to the
Classification and Labelling Inventory (656,741) and which are not regularly updated239
.
1% of notified substances are already updated regularly (and re-classified where
appropriate), so by taking this into account (3-5% minus 1%), it gives an estimate of
approximately 13,000 - 26,000 notifications requiring re-classification each year, which
when divided by the number of companies that have submitted C&L notifications (12,244),
gives an estimate of 1.06 – 2.12 notifications per company. This means that on average each
company would incur a re-classification cost of €424 - €848, and a total annual cost to all
companies of approximately €5,200,000 - €10,400,000 (€424 - €848 x 12,244). In the two
year period between updates proposed by this policy measure, the total cost to all companies
would be approximately €10,400,000 - €20,800,000.
By taking the 2-4% range and applying it to the number of notifications submitted by large
companies (405,713) and SMEs (251,028), this gives an estimate of approximately 8,100-
16,200 notifications and 5,000-10,000 notifications requiring re-classification by large
companies and SMEs respectively each year. This means that on average each large
company would have 1.37-2.73 notifications requiring re-classification (8,100-16,200 /
5,931 large companies) and each SME would have 0.79-1.58 notifications requiring re-
classification (5,000-10,000 / 6,313 SMEs) and incur a re-classification costs of €548-1,092
(€400 x 1.37-2.73) and €316-632 (€400 x 0.79-1.58) respectively. The total annual costs to
238
See footnote 16.
239
ECHA informed that 1% of the notified classifications are updated per year.
303
large companies are approximately €3,250,000 - €6,500,000 (€548-1,092 x 5,931 =
€3,250,188-€6,476,652) and approximately €2,000,000 - €4,000,000 to SMEs (€316-632 x
6,313 = €1,994,908-€3,989,816). In the two year period between updates proposed by this
policy measure, the total cost to large companies would be approximately €6,500,000 -
€13,000,000 and €4,000,000 - €8,000,000 for SMEs.
Cost of updating and distributing revised Safety Data Sheet (SDS)
Following any re-classifications, companies will be required to update and distribute revised
Safety Data Sheet to reflect the new classification. The 2017 Fitness Check estimated an
average cost of €250 per substance or mixture of updating an SDS due to a change in
classification. SDS help ensure that those who use chemicals in the workplace use them
safely without risk of harm to users or the environment. Only companies supplying
hazardous substances and mixtures to other companies (downstream users, distributors) are
required to provide a SDS, meaning that not all notifiers who re-classify their substances
will have to produce a revised SDS. Therefore, only a proportion of notifications requiring
re-classification will also require a subsequent revised SDS. A recent economic analysis of
the Impacts of the Chemicals Strategy for Sustainability240
found that just over a quarter of
the products identified in the data gathering exercise had an industrial end use and were
classified under the following hazard classes: CMR, PBT, vPvB. EDC, respiratory
sensitisation, STOT RE, STOT SE, skin sensitisation, aquatic chronic toxicity,
immunotoxicity, or neurotoxicity. Although this does not include products classified under
all hazard classes, and includes products classified under some hazard classes not currently
under CLP, this sample is considered large enough to be representative of the end uses of
all hazardous products. This means that approximately 3,250 – 6,500 of the re-classified
substances would require an SDS after each year (2,025 – 4,050 for large companies and
1,250 – 2,500 for SMEs), which would lead to a cost per company of €66.25 - €132.50,
€85.63 - €170.63 per large company, and €49.38 - €98.75 per SME (these calculations take
the average number of notifications per company / large company / SME requiring
reclassifications presented in the paragraph above, divide by four and multiple by the unit
cost of €250 per SDS). SDS may also need an update for mixtures containing the reclassified
substances, where the substance concentration in the mixture would be above the general
concentration limit. Such limits vary by several order of magnitude. It was estimated from
Annex 8 that for each substance, 11 mixtures are manufactured. To test the variability,
frequencies of updates of mixture SDS 10, 30 and 50% were used, though these figures
contain uncertainties. This gives total annual costs of approximately €8,900,000 -
€17,900,000 (3,250-6,500 x €250 x 11) for all companies, €5,600,000 – €11,100,000 (2,025
– 4,050 x €250 x 11) for large companies, and €3,400,000 - €6,900,000 (1,250 – 2,500 x
€250 x 11) for SMEs. In the two year period between updates proposed by this policy
measure, the total cost to all companies would be approximately €17,900,000 - €35,800,000,
€11,200,000 - €22,200,000 to large companies, and €6,800,000 - €13,800,000 for SMEs.
Cost of re-labelling in line with re-classification
To ensure that customers receive information on hazards, suppliers of substances and
mixtures should ensure that they are labelled in accordance with the classification derived
240
Cefic, Economic Analysis of the Impacts of the Chemicals Strategy for Sustainability – Phase 1 Report,
2021.
304
for each substance and mixture. CLP labels must include hazard pictograms, hazard and
precautionary statements, and signal words derived from a hazard classification. Therefore,
a change in classification will require a change in labelling to ensure compliance with
labelling provisions under the CLP Regulation and accurate communication of hazard
information to users of substances.
Labels are the only tool for direct communication to consumers, but they may also serve to
draw the attention of workers to the more comprehensive information on substances or
mixtures provided in safety data sheets (SDS). Labelling applies to all substances and
mixtures, with the exception of those substances used exclusively in products that are
exempt from CLP, such as cosmetics. It is not known what percentage of substances in the
Classification and Labelling Inventory are exempt, but the proportion is considered to be a
minority, so for the purposes of this analysis all notifications that are updated with revised
classifications are assumed to require subsequent re-labelling. However, as mentioned
previously one quarter of substances are assumed to be supplied to industrial uses and
therefore would not need consumer labelling.
The 2017 Fitness Check241
estimated the average cost of re-labelling to be €388 per
substance and €475 per mixture. Assuming 75% of notifications requiring re-classification
each year would result in relabelling, would equate to 9,750 – 19,500 (13,000 – 26,000 *
0.75) for all companies, 6,000 – 12,000 (8,100-16,200 * 0.75) for large companies, and
3,750 – 7,500 (5,000 – 10,000 * 0.75) for SMEs. Again, assuming 11 mixtures are
manufactured for each substance, this would equate to annual costs of €51,000,000 –
€100,000,000 for all companies, €31,400,000 – €62,700,000 for large companies, and
€19,600,000 – 39,200,000 for SMEs.242
In the two year period between updates proposed
by this policy measure, the total cost to all companies would be approximately €102,000,000
- €200,000,000, €62,800,000 – €125,400,000 for large companies, and €39,200,000 –
€78,400,000 for SMEs.
Cost of navigating the Classification and Labelling Inventory
Each of the three policy measures under consideration aim to address the problem of
incorrect, diverging or obsolete information on self-classification in the Classification and
Labelling Inventory, in order to make data in the Inventory easier to understand and use.
Therefore, an expected benefit to the conduct of business is a reduction in the time taken by
Inventory users to find the most relevant and reliable data. The time saving is expected to
be greatest amongst inexperienced users, such as SMEs.
Based on stakeholder feedback, the 2017 Fitness Check found 36% of manufacturers,
formulators, distributors and importers use the Classification and Labelling Inventory
multiple times a week. On average, it was estimated that a large company spends 2 hours
per month (24 hours per year) checking the Inventory, with a cost of €987 per year (based
on an hourly rate of €41.126). SMEs were estimated to spend half the time, and thus incur
half the cost (€493.50 per year).243
241
See Footnote 16.
242
See Footnote 237.
243
See Footnote 237.
305
The reduction in time spent using the Classification and Labelling Inventory is dependent
on the effectiveness of policy measure #6 in addressing the problem of incorrect, diverging
or obsolete information on self-classification in the inventory. However, if policy measure
#6 led to users of the inventory spending half the time navigating the inventory due to
improvements in self-classifications, this would equate to a cost saving of €493.50 per large
company and €246.75 per SME. Multiplying these figures by the total number of large
companies and SMEs gives total costs of approximately €6,650,000 for large companies,
€2,300,000 for SMEs, and a total cost of €8,950,000.
Total administrative burden on businesses
Policy measure #6 foresees that notifications should be reviewed and updated every 2 years.
After the first review, the subsequent reviews are expected to incur smaller recurring costs.
This is because significantly fewer reclassifications, and subsequent re-labelling and
provision of updated safety data sheet, will be required in following reviews, and most are
expected to have been performed during the first review. The total cost for the first two-year
review period is €125,840,000 – €261,500,000, central estimate: €51,250,000, which is the
combined total of the following costs:
cost of validating/updating notifications: €4,900,000
cost of re-classification: €10,400,000 - €20,800,000
cost of re-labelling: €102,000,000 - €200,000,000
cost of providing updated SDS: €17,900,000 – €35,800,000
The total annual recurring cost of subsequent two-year review periods are expected to be
the same as the cost of reviewing notifications plus the cost of reclassifying a small number
of substances. It is assumed that only 10% of the number of substances that required
reclassification the first time would require reclassification during subsequent reviews.
Therefore, the total annual recurring cost of subsequent two-year review periods is
€17,930,000 – €30,560,000, which is the combined total of the following costs:
cost of validating/updating notifications: €4,900,000
cost of re-classification: €1,040,000 - €2,080,000
cost of re-labelling: €10,200,000 - €20,000,000
cost of providing updated SDS: €1,790,000 - €3,580,000
The cost of time saved navigating the Classification and Labelling Inventory would be
realised every year, and is expected to remain the same, pending the 3% discount rate.
Assuming the obligation under policy measure #6 occurs every 2 years, the total (recurring)
cost with a discount rate of 3%, €343,284,062 (central estimate), where the savings from
navigating the CLI would equal to €216,569,010 (discount rate 3%).
It needs to be noted however, that, legally speaking, companies are required to update their
notifications and communicate to ECHA ‘…when… a decision to change the classification
and labelling of the substance has been taken’ (Article 40(2) of CLP). The costs associated
with the update need therefore to take into account the obligation that notifiers have
currently to update their notification when, following a new evaluation of data, they have
decided to change the classification. Any subsequent cost triggered by such updating
obligation, in terms of re-notification, re-classification and re-labelling should not only be
306
attributed to the obligation to update every two years but also to the existing updating
obligation.
For measure #5 – swift Classification and Labelling Inventory update, the same type of
costs would apply but only to 4% of notified substances were new data are available as
described above. 1% of the notified substances are already regularly updated (and re-
classified where appropriate). The costs of measure #5 are those of measure #6 without the
notification check for 97% of the notified substances (i.e the cost of validation/updating
notifications is avoided). Therefore, the central estimate is €277,412,668. The savings
would be the same as for measure #6.
SMEs
The average number of notifications per SME (40) is not much less than the average number
of notifications per large company (68). Therefore, there is only a small difference between
the cost estimates per company presented above for SMEs and large enterprises.
Considering the substantial differences in the profits of SMEs and large companies, the costs
of policy measure #6 will be disproportionately felt amongst SMEs. This in turn may
negatively impact the competitiveness of SMEs.
Conversely, SMEs rely on public information sources such as the CLI more heavily than
larger companies, and therefore improved access to information will benefit the smaller
companies more compared to larger companies. Under policy measure #6 SMEs could see
a reduction in compliance costs and a subsequent increase in their competitiveness in the
long-term.
Sectoral competitiveness, trade and investment flows
The updating and reviewing of notifications aims to harmonise classifications and improve
the quality of the CLI data, which in turn will benefit all businesses and increase
competitiveness, especially SMEs who rely on public information sources such as the
Classification and Labelling Inventory more heavily than larger companies. However, in
the short-term the competitiveness of SMEs may be hindered due to the additional burden
for smaller companies when reviewing and updating their self-classifications. A weak
positive impact is expected.
Public Authority Costs
Cost of reviewing C&L notifications
Based on discussions held at the Competent Authorities for REACH and CLP expert group
on the re-design of the CLI, it was stated that ECHA does not have enough available
resources for manual screening of C&L data or contacting notifiers. Therefore, they rely on
automated IT screening of obvious internally inconsistent data. Discussions between ECHA
and the study team revealed that although ECHA would not be checking new notifications,
their submission would represent an additional administrative burden to process the
notifications (more submissions lead to more company support (technical, regulatory) as
well as more IT incidents). ECHA and the Commission are not planning to hire any
additional staff for these tasks so this policy measure would result in resources being shifted
away from other priorities. This shift of resources may impact ECHA’s other activities, for
307
example the redesigning of the CLI. As no increase in staffing levels is expected, the
employment costs to ECHA of reviewing C&L notifications will be negligible, however the
impact to the organisation and other activities could be significant.
A summary of the costs and benefits of policy measure #6 are provided below.
Summary of cost and benefits of policy measure #6
Costs - businesses
Total one-off costs over a 20-year period €130,200,000 –
€256,600,000 (mid-estimate:
€193,400,000)
Recurring costs every 1 year €8,960,000 – €15,280,000
(mid-estimate: €12,120,000)
Total recurring costs over a 20-year period €166,180,000 –
€279,940,000 (mid-estimate:
€223,060,000)
PV of one-off costs (20 years; 3%) €175,029,703 –
€344,951,011 (mid-estimate:
€259,990,357)
PV of one-off costs (20 years; 3%) (annualized) €8,751,485 – €17,247,551
(mid-estimate: €12,999,518)
PV of recurring costs (20 years; 3%) €223,398,126 –
€376,327,304 (mid-estimate:
€299,862,715)
Total PV – costs - businesses €398,427,828 –
€721,278,315 (mid-estimate:
€559,853,072)
Costs – public authorities
Total one-off costs over a 20-year period -
Recurring costs every 1 year -
Total recurring costs over a 20-year period -
PV of one-off costs (20 years; 3%) -
PV of recurring costs (20 years; 3%) -
Total PV – costs – public authorities -
Total PV cost of policy measure #6 €398,427,828 –
€721,278,315 (mid-
estimate: €559,853,072)
Benefits (cost savings) - businesses €161,100,000
PV benefits - businesses €216,569,010
Benefits (cost savings) – public authorities -
PV – benefits – public authorities -
Benefits - society -
PV - benefits - society -
Total OV - benefits -
308
Net Present Value - NPV (PV benefits – PV costs) €181,858,818 –
€504,709,305 (mid-estimate:
€343,284,062)
A summary of the present value (3% discount) costs and benefits of policy measure #6 are
provided below.
Summary of costs and benefits (PV; 20 years; 3%) of policy measure #6 by type
Costs
Businesses Administrations Society
Direct adjustment
costs
- - -
Direct
administrative costs
€6,587,139 - -
Direct regulatory
fees and charges
- - -
Indirect costs €332,556,435 –
€655,406,922 (mid-
estimate €493,981,678)
- -
Benefits
Description Businesses Administrations Society
Direct benefits
Direct cost savings €216,569,010 - -
#3 Require notifiers with classifications that diverge from the entry agreed by most
notifiers to update their notifications with a justification for any divergence
Another measure that could be useful for notifiers to understand the reason for divergence
in the classification and labelling information would be to require notifiers with
classifications that diverge from the entry agreed by most notifiers to update their
notifications with a justification for any divergence. The update would be a one off measure.
This measure will be eased by ECHA’ s planned improvements of the IT tool – belonging
to the baseline - i.e. to improve the visibility of the reason for divergence with the
information currently available in the C&L inventory. This reason for divergence is
however not always known to the notifier: it might be in case the reason is e.g. impurity,
additive or form). When the reason is something else (underlying data or interpretation of
data), the notifier will not be able to provide such a reason as they would need to know the
details of how others derived their classifications.
309
Table 91: Policy measure #3 Require notifiers with classifications that diverge from the entry agreed by the
majority of notifiers to update their notifications with a justification for any divergence in classification
Impact Category Impact Positive
or
negative
Direct or
indirect
Monetised
impacts
One off or
recurrent
PV
annualised
impacts
Administrative
burdens on
business
Cost of
justifying
diverging
notifications
(-) Direct
Total cost of
€1,800,000
across all
notifiers
One off
€120,988
Cost of re-
classification
(-) Indirect
Total cost of
€5,200,000 -
€10,400,000
(mid-point of
€7,000,0000
One off
€349,522 -
€699, 043
(mid-point:
€524,283)
Cost of
updating and
distributing
revised Safety
Data Sheet
(SDS)
(-) Indirect
Total cost of
€8,900,000 -
€17,900,000
(mid-point of
€13,400,000
One off
€598,220 -
€1,203-161
(mid-point of
€900,690
Cost of re-
labelling in line
with re-
classification
(-) Indirect
Total cost of
€51,000,000 –
€100,000,000
(mid-point of
€75,500,000
One off
€3,428,001 -
€6,721,571
(mid-point of
€5,074,786)
Cost of
navigating the
CLI
(+) Direct
Cost saving of
€8,950,000
(€2,300,000 for
SMEs)
Recurrent
(annual)
from year
2
€12,031,612
(€3,091,923
for SMEs)
Positions of
SMEs
Operation of
SMEs
(o) Indirect Not quantified Recurrent -
Sectoral
competitiveness,
trade and
investment flows
Additional
information and
clarity on self-
classifications
(+) Indirect Not quantified Recurrent -
Public
Authorities
Cost of
reviewing C&L
notifications
(o) Indirect Not quantified Recurrent -
Administrative Costs
Cost of justifying diverging notifications
Policy measure #3 requires notifiers that have classifications which differ from the
consensus classification, to update their notifications with a justification for the divergence
or remove the notification if it diverges because it is incorrect. Possible reasons for
divergence include:
Different hazardous impurities, additives or ingredients might be present;
Properties such as the physical form, the pH, the flash point might be different;
310
Suppliers need to interpret the data from scientific studies when they classify a chemical,
and different suppliers might reach a different conclusion, which is sometimes justifiable.
Data on the Classification and Labelling Inventory that was provided by ECHA to the
study team of the study underlying this Staff Working Document, shows the level of
divergence in the inventory. 21.61% of substances have more than one classification which
equates to 68.9% (517,739) of notifications. An estimate of 5 minutes to provide a
justification has been assumed by the study team. This is the case when the legitimate
reasons for divergence in classifications are well known and it would not be necessary to
provide a lengthy explanation. At a recent ad-hoc meeting of the Competent Authorities for
REACH and CLP205
, ECHA mentioned that they already hold data on this, such as the
presence of impurities / additives, physical states, and hydrated forms, although it is not
published in the public CLI244
. Therefore, a significant number of notifications that diverge
may not require any review, and therefore no administrative cost will be incurred.
The maximum total cost of justifying divergence is calculated to be approximately
€1,800,000 based on all the 517,739 notifications requiring justification, a time estimate of
5 minutes, and an hourly rate of €41.126. Data on the number of notifiers from which the
517,739 diverging notifications were submitted was not available, so an average cost per
company was not able to be reliably calculated.
The aim of the planned re-design of the Classification and Labelling Inventory is to provide
clarity on data held in the inventory, which will include publishing the reason for
divergence. Therefore, providing information that justifies a diverging classification may
become a very efficient tick-box exercise representing a negligible administrative burden to
notifiers. In discussions with the study team in charge of the study underlying this Staff
working document, ECHA has also highlighted that they already hold information on
physical form and impurities, so for those notifiers that have already provided this
information, no action from them would be required.
Cost of re-classification
As explained previously, around 2-4% (mid-point of 3%) of C&L notifications are expected
to require re-classification each year, which gives an estimate of just over 13,000 – 26,000
notifications. Based on estimates from the Fitness Check245
that the average cost of
undertaking re-classification activities is €400, this gives an approximate total cost range of
€5,200,000 - €10,400,000 (mid-point of €7,800,000). However, it should be noted that if
only 1% of notifications are being updated regularly, there may be a greater percentage of
notifications that would require re-classification.
Although only a proportion of notifications will require review under this policy measure,
it is expected that the estimated 13,000 – 26,000 notifications requiring re-classification
would come from this subset of notifications.
Cost of updating and distributing revised Safety Data Sheet (SDS)
244
ECHA publish the fact that a classification is indicated to depend on an impurity/additive. It is assumed
that companies systematically indicate this when notifying.
245
See Footnote 237.
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Following any re-classifications, companies will be required to update and distribute revised
SDS to reflect the new classification. The 2017 Fitness Check estimated an average cost of
€250 per substance or mixture of updating a safety data sheet due to a change in
classification. Safety data sheets help ensure that those who use chemicals use them safely
without risk of harm to users or the environment.246
According to Article 31 of REACH,
only companies supplying hazardous substances and mixtures to ‘recipients’ – defined as
downstream users or distributors (Article 3 (34) of REACH - will be required to supply
SDS, meaning that not all notifiers who re-classify their substances will have to produce a
revised SDS. Therefore, only a proportion of the 13,000 – 26,000 notifications requiring re-
classification will also require a subsequent revised SDS. A recent economic analysis of the
Impacts of the Chemicals Strategy for Sustainability247
found that just over a quarter of the
products identified in the data gathering exercise had an industrial end use and were
classified under the following hazard classes: CMR, PBT, vPvB. EDC, respiratory
sensitisation, STOT RE, STOT SE, skin sensitisation, aquatic chronic toxicity,
immunotoxicity, or neurotoxicity. Although this does not include products classified under
all hazard classes248
, and includes products classified under some hazard classes not
currently under CLP249
, it is considered large enough to be representative of the end uses of
all hazardous products. This means that approximately 3,250 – 6,500 of the 13,000 – 26,000
re-classified substances would require a safety data sheet each year, which would lead to a
cost per company of €66.25 - €132.50, €85.63 - €170.63 per large company, and €49.38 -
€98.75 per SME. This gives total annual costs of approximately €8,900,000 - €17,900,000
(3,250-6,500 x €250 x 11) for all companies, €5,600,000 – €11,100,000 (2,025 – 4,050 x
€250 x 11) for large companies, and €3,400,000 - €6,900,000 (1,250 – 2,500 x €250 x 11)
for SMEs.
Cost of re-labelling in line with re-classification
To ensure that customers receive information on hazards, suppliers of substances and
mixtures should ensure that they are labelled in accordance with the classification derived
for each substance and mixture. CLP labels must include hazard pictograms, hazard and
precautionary statements, and signal words derived from a hazard classification. Therefore,
a change in classification will require a change in labelling to ensure compliance with
labelling provisions under the CLP Regulation and accurate communication of hazard
information to customers.
Labels are the only direct tool for communication to consumers, but they may also serve to
draw the attention of workers to the more comprehensive information on substances or
mixtures provided in safety data sheets (SDS). Labelling applies to all substances and
mixtures, with the exception of those substances used exclusively in products that are
exempt from CLP, such as cosmetics. It is not known what percentage of substances in the
Classification and Labelling Inventory are exempt, but the proportion is considered to be a
minority, so for the purposes of this analysis all notifications that are updated with revised
classifications are assumed to require subsequent re-labelling.
246
See Footnote 237.
247
See Footnote 240.
248
According to Article 31(a) of REACH a SDS is required for all substances and mixtures meeting the CLP
criteria for classification as hazardous.
249
EDs, PBTs e.g.
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The Fitness Check of CLP estimated the average cost of re-labelling to be €388 per
substance and €475 per mixture. Assuming 75% of notifications requiring re-classification
each year would result in relabelling, would equate to 9,750 – 19,500 (13,000 – 26,000 *
0.75) for all companies, 6,000 – 12,000 (8,100-16,200 * 0.75) for large companies, and
3,750 – 7,500 (5,000 – 10,000 * 0.75) for SMEs. Again, assuming 11 mixtures are
manufactured for each substance, this would equate to annual costs of €51,000,000 –
€100,000,000 for all companies, €31,400,000 – €62,700,000 for large companies, and
€19,600,000 – 39,200,000 for SMEs.
Cost of navigating the Classification and Labelling Inventory
Each of the three policy measures under consideration aim to address the problem of
incorrect, diverging or obsolete information on self-classification in the CLI, in order to
make data in the Inventory easier to understand and use. Therefore, an expected benefit to
the conduct of business is a reduction in the time taken by Inventory users to find the most
relevant and reliable data. The time saving is expected to be greatest amongst inexperienced
users, such as SMEs.
Based on stakeholder feedback, the 2017 Fitness Check found 36% of manufacturers,
formulators, distributors and importers use the Classification and Labelling Inventory
multiple times a week. On average, it was estimated that a large company spends 2 hours
per month (24 hours per year) checking the Inventory, with a cost of €987 per year (based
on an hourly rate of €41.126). SMEs were estimated to spend half the time, and thus incur
half the cost (€493.50 per year).
The reduction in time spent using the CLI is dependent on the effectiveness of policy
measure #3 in addressing the problem of incorrect, diverging or obsolete information on
self-classification in the CLI. It is expected that measure #3 will have a positive impact on
reducing the number of diverging classifications and improving transparency on the
remaining divergence. Therefore, it is realistic to expect that policy measure #3 could lead
to users of the CLI to spend half the time navigating the CLI due to improvements in self-
classifications, this would equate to a cost saving of €493.50 per large company and €246.75
per SME. Multiplying these figures by the total number of large companies and SMEs gives
total costs of approximately €6,650,000 for large companies, €2,300,000 for SMEs, and a
total cost of €8,950,000.
Total administrative burden on businesses
The total one-off administrative cost of policy measure #3 is €24,215,000 – €32,825,000
(cost of providing justifications + cost of reclassification + cost of relabelling + cost of
providing SDS). The recurring cost would apply to new notifications and therefore this cost
is expected to be budgeted into the cost of preparing new notifications. However, the cost
of time saved navigating the Classification and Labelling Inventory would be realised every
year, which needs to be factored into the recurring cost, which equates to €9,950,000.
As in the case of the bi-yearly updates measure described above, it needs to be noted
however, that, legally speaking, companies are required to update their notifications and
communicate to ECHA ‘…when… a decision to change the classification and labelling of
the substance has been taken’ (Article 40(2) of CLP). The costs associated with the update
need therefore to take into account the obligation that notifiers have currently to update their
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notification when, following a new evaluation of data – e.g. because they become aware
that they have to re-classify because they had not duly taken into account an impurity - they
have decided to change the classification. Any subsequent cost triggered by such updating
obligation, in terms of re-notification, re-classification and re-labelling should not only be
attributed to the obligation to update in order to display the reason for divergence more
clearly but also to the existing updating obligation.
Position of SMEs
Operation of SMEs
Information on the number of diverging classifications per SME and large enterprise was
not available. However, assuming a similar distribution amongst SMEs and large enterprises
as was observed in the whole dataset of the Classification and Labelling Inventory, the
average number of diverging notifications per SME can be expected to be not much smaller
than the average number of diverging notifications per large enterprise. Therefore, only a
small difference between the cost incurred for SMEs and large enterprises is expected.
Considering the substantial differences in the profits of SMEs and large companies, the costs
of policy measure #3 would be disproportionately felt amongst SMEs, which in turn may
negatively impact the competitiveness of SMEs.
Conversely, SMEs rely on public information sources such as the Classification and
Labelling Inventory more heavily than larger companies, and therefore improved access to
information will benefit the smaller companies significantly compared to larger companies.
Under policy measure #3 SMEs could see a reduction in compliance costs and a subsequent
increase in their competitiveness in the long-term. Due to both the positive and negative
impacts, overall a limited impact is expected.
Sectoral competitiveness, trade and investment flows
The obligation to review and justify diverging classifications aims to improve the
harmonisation of classifications and improve the quality of the Classification and Labelling
Inventory data, which in turn will benefit all businesses and increase competitiveness,
especially SMEs who rely on public information sources such as the Classification and
Labelling Inventory more heavily than larger companies. However, in the short-term the
competitiveness of SMEs may be hindered due to the additional burden felt by smaller
companies when reviewing and updating their self-classifications. A weak positive impact
is expected.
Public Authority Costs
Cost of reviewing C&L notifications
Discussions between ECHA and the study team in charge of the study underlying this Staff
working document revealed that ECHA would not have sufficient resources to do manual
screening of Classification and Labelling data. IT screening would be more feasible, but
would also cost resources as such screening results would need follow-up to generate any
effect.
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ECHA and the Commission have not planned to hire any additional staff for this task, so
this policy measure would result in resources being shifted away from other priorities. As
no increase in staffing levels is expected, the employment costs to ECHA of reviewing
Classification and Labelling notifications will be negligible but ECHA’s other activities are
expected to be impacted.
It is envisaged that an additional field would be added to IUCLID (format used for both
C&L notification and REACH registration) to allow notifiers to provide their justifications.
In discussions with the study team of the study performed for the purposes of this Staff
Working Document, ECHA highlighted that this would not represent a significant cost.
Environmental Impacts
Each of the three policy measures under consideration aims to improve the accuracy,
transparency, and ease-of-use of information in the CLI. Each measure is therefore expected
to result in similar environmental and human health impacts although their magnitude is
expected to differ based on their effectiveness.
Improvements in the Classification and Labelling Inventory will enhance the
communication of hazard information to consumers, professional users and industrial
workers via the inventory, which will allow them to make better decisions on how they use
hazardous substances. An increase in the accuracy of self-classifications will also feed into
the accurate labelling of hazardous substances and mixtures supplied to consumers,
professional users and industrial workers. This is expected to have a positive impact on the
appropriateness of risk management and waste disposal measures in the workplace, thus
leading to improved environmental protection –. This would be expected to positively
reduce pollution affecting aquatic species, surface and ground water and land
contamination.
More accurate labelling of consumer products may also reduce sales of environmentally
harmful chemicals to consumers, as better information will empower consumers to make
more informed decisions on their product purchases. Knowing the true hazards of
environmentally harmful chemicals might deter consumers from purchasing them in favour
of less harmful alternatives.
The environmental benefits from the policy measures are indirect impacts as more accurate
information on classification does not automatically lead to improved environmental
protection. Subsequent action on re-labelling products and introducing workplace safety
measures are required for any benefit to be realised. Therefore, it is not possible to
accurately quantify the scale of the environmental benefits from each policy measure.
However, the positive impact is expected to be weak for both policy measure #6 and #3 due
to the indirect nature of any improvements to environmental protection. Policy measure #4
is also expected to have a limited impact as publication of notifier details relies on
subsequent collaboration amongst duty holders and previous initiatives aimed at promoting
collaboration have had limited results.
However, the fact that the positive impact on the environment of each of these measures in
itself is expected to be low should not constitute a sufficient reason for them not be pursued,
as in fact the exact benefits are unknown in view of the uncertainty of the further measures
they need to be combined with.
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Table 92: Environmental impacts
Impact Category Impact Positive
or
negative
Direct or
indirect
One off or
recurrent
The likelihood or scale of
environmental and climate
risks
Impact on environmental
protection
(+) Indirect Recurrent
Social impacts
The measures under consideration aim to reduce the level of divergence and improve the
transparency of information in the Classification and Labelling Inventory. Each measure is
therefore expected to have the same human / social impacts, although their magnitude is
expected to differ based on the effectiveness of each policy measure.
Table 93: Social impacts
Impact
Category
Impact Positive
or
negative
Direct
or
indirect
One off or
recurrent
Employment
Impact on industry jobs (+) Indirect One off
Impact on public authority jobs (o) Indirect One off
Consumers and
households Impact on consumer awareness (+) Indirect Recurrent
Innovation
Impact on innovation (+) Indirect Recurrent
Public health
and safety and
health systems
Impact on protection of human health (+) Indirect Recurrent
Working
conditions, job
standards and
quality
Impact on worker protection (+) Indirect Recurrent
Employment
Impact on industry jobs
Companies with a large number of self-classifications may have to increase their number of
regulatory staff to accommodate the additional regulatory burden. However, the cost
estimates of each policy measure are not significant enough to cause any discontinuation of
business, and therefore each policy measure is expected to have a weakly positive impact
on the levels of employment within the EU chemical sector. In addition, the impacts of the
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policy measures by themselves are not large enough to predict to what extent substitution
of hazardous substances with less harmful (non-hazardous) substances will take place.
Policy measures #6 and #3 involve the most significant economic costs and are expected to
have the most positive impacts on employment.
Impact on public authority jobs
Based on discussion between ECHA and the study team of the study underlying this Staff
Working Document, no increase in staff within ECHA is foreseen under any of the policy
measures. Therefore, based on this assumption, all policy measures will have no
impact. However, the measures is expected to have an impact on ECHA’s overall workload
- in particular to keep the old dissemination platform operational and in parallel rebuild a
new dissemination platform - and hence may require shifting of priorities.
Consumers and households
Impact on consumer awareness
Information on self-classifications in the Classification and Labelling Inventory is used by
downstream users to complete their labelling obligations under the CLP Regulation for
products they place on the market. Improvements in the accuracy and clarity of self-
classifications in the inventory is therefore expected to improve the accuracy of labelling
elements of consumer products (provided they are not excluded from the scope of CLP in
accordance with Article 1(5) of CLP and the product specific legislation does not refer to
CLP labelling provisions). This will ensure consumers are correctly informed on the hazards
associated with a product and can make more-informed decisions on product purchases.
Making the identity of the notifiers public – subject to duly motivated confidentiality
requests - will increase transparency.
Innovation
Impact on innovation
A vast and credible data set of hazard information will provide industry with useful
information to guide their innovation and the confidence to make innovation decisions
without having to conduct expensive research internally. A weakly positive impact on
innovation is expected.
Public health and safety and health systems
Impact on protection of human health
Improvements in the accuracy of classifications will lead to the use of improved consumer
product labels and thus will ensure that consumers are correctly informed on the hazards
associated with the products they purchase. This is expected to lead to the safer use, storage,
and disposal of chemical products, thus resulting in improvements in the protection of
human health.
In addition, the enhanced accuracy of the information in the Classification and Labelling
Inventory will be used by poison centres to provide more valuable medical advice. When
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notifying mixtures to poison centres, notifiers must include the classification of each
substance within the composition. Often, formulators rely on the information and
classifications provided by the substances’ suppliers. However, different suppliers of the
same substance can provide differing classifications, which can be the result of impurities
within the substance, differing access to data, or lack of agreement on self-classification. In
these cases, it is difficult for the notifiers to select one dataset over another. ECHA’s current
practice is to advise notifiers to go back to their suppliers to reconcile these differences.
However, this is unlikely to be a practical solution and can be time consuming.
These conflicting classifications for identical substances could result in inconsistent medical
advice given for exposure incidents involving the same substance(s), within the same
Member State or across Member States. For example, two product notifications that have
identical formulations (except minor concentration differences) submitted by two different
companies, could result in a poison centre advising specific medical advice for one product
and not for the other, based on diverging classifications of substances within the product’s
formulation. Therefore by improving the data in the Classification and Labelling Inventory,
poison centres can use the inventory to resolve these differences and deliver consistent and
reliable medical advice.
The human health benefits from the policy measures are indirect impacts as more accurate
information on classification does not automatically lead to improved protection for human
health. Subsequent action on re-labelling products and introducing workplace safety
measures are required for any benefit to be realised. Therefore, it is not possible to
accurately quantify the scale of the human health benefits from each policy measure. The
positive impact is nevertheless expected to be weak. Policy measure #4 is expected to have
a limited impact in itself as publication of notifier details relies on subsequent collaboration
amongst duty holders and previous initiatives aimed at promoting collaboration have had
limited results. However, it is expected to still have a positive impact if combined with
collaboration.
Impact on worker health
Improvements in the accuracy and clarity of self-classifications in the Classification and
Labelling Inventory are also expected to improve the accuracy of labelling elements of
chemicals supplied to industrial and professional users. This may lead to more appropriate
risk management measures being implemented in the workplace, leading to greater
protection of worker health.
However, it is not because the positive impact on human health of each of the measures on
its own is weak that it should not be pursued, because the exact benefits are unknown in
view of the uncertainty of the further measures they need to be combined with.
Transparency
Making the identity of notifiers public will have a certain benefit for transparency. However
that impact will be limited as there are around 10 million companies in the groups (not all
different companies - still associated with notified substances), whereas only 750,000,000
notifier names would become public.
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It will also allow aligning with substances registered under REACH - for which the names
of the registrants are public, subject to duly motivated confidentiality requests.
There were several reasons which drove ECHA, supported by the Commission, to make the
registrant’s names public under REACH, inter alia as it was justified by reference to Article
119(2) (d) of REACH according to which ECHA should give access to any information
included in the Safety Data Sheet (SDS) – subject to a duly motivated confidentiality request
– which SDS includes the name of registrants. The objective of REACH regarding
transparency with regard to risks and hazards of substances and industry responsibility in
managing such risks also justified such interpretation. That transparency objective fits with
the access to environmental information under the Aarhus Convention, which encompasses
information of an administrative nature.
To be noted that Article 77(2) of REACH which provides for ECHA’s competence in
establishing and maintaining REACH and CLP databases, refers to Article 119(1) and (2)
of REACH regarding the obligation to make information of these databases publicly
available. This supports that a parallel measure to REACH would be implemented. Recital
58 of CLP confirms that information provided for the CLI and under REACH should benefit
from the same degree of accessibility and protection of information.
A summary of the costs and benefits of policy option #3 are provided below.
Summary of cost and benefits of policy option #3
Costs - businesses
Total one-off costs over a 20-year period €66,900,000 - €130,100,000
(mid-estimate: €98,500,000)
Recurring costs every 1 year
Total recurring costs over a 20-year period
PV of one-off costs (20 years; 3%) €89,314,851 - €174,275,506
(mid-estimate:
€131,795,178)
PV of one-off costs (20 years; 3%) (annualized) €4,496,731 - €8,744,764
(mid-estimate: €6,620,747)
PV of recurring costs (20 years; 3%) -
Total PV – costs - businesses -
Costs – public authorities
Total one-off costs over a 20-year period -
Recurring costs every 1 year -
Total recurring costs over a 20-year period -
PV of one-off costs (20 years; 3%) -
PV of recurring costs (20 years; 3%) -
Total PV – costs – public authorities -
Total PV cost of policy option #3 €89,314,851 - €174,275,506
(mid-estimate:
€131,795,178)
Benefits (cost savings) - businesses €161,100,000
PV benefits - businesses €216,569,010
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Benefits (cost savings) – public authorities -
PV – benefits – public authorities -
Benefits - society -
PV - benefits - society -
Total OV - benefits -
Net Present Value - NPV (PV benefits – PV costs) €41,673,739 – €126,634,393
(mid-estimate: €84,154,066)
A summary of the present value (3% discount) costs and benefits of policy measure #3 are
provided below.
Summary of costs and benefits (PV; 20 years; 3%) of policy measure #3 by type
Costs
Businesses Administrations Society
Direct adjustment
costs
- - -
Direct
administrative costs
€2,419,765 - -
Direct regulatory
fees and charges
- - -
Indirect costs €89,314,851 –
€174,275,506 (mid-
estimate:
€131,795,178)
- -
Benefits
Description Businesses Administrations Society
Direct benefits
Direct cost savings €216,569,010 - -
Stakeholder Opinions
#6 Require notifiers to validate/update entries in the Classification and Labelling
Inventory every 2 year(s)
Of the stakeholders that responded to policy measure #6 one Trade Association was
supportive in suggesting a general improvement in creating a legal obligation to delete
inactive entries, for example after 2-3 years of inactivity. However a public authority also
noted that under the proposed policy measure #6 there would be significant time and cost
investment required from individual members of group submissions, which the public
authority has suggested is responsible for the majority of notifications to the C&L inventory.
The requirement for group members to take action could result in a need for a “complete
restart of the inventory”. Furthermore a Public Authority and a Member State Competent
Authority have indicated that from their experience regular updates don’t necessarily
provide any benefit to the accuracy of the Inventory or even provide any new relevant
information. One industry association suggested a softer approach with a simple update
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mechanism rather than a full re-submission, as full re-submissions should only be required
as a last resort.
#4: Publication of the identity of notifiers (i.e. company names and contact details) in the
CLI
Of the two stakeholders that responded in support of this measure, one industry association
noted that they understand the concerns in regard to protecting confidential business
information, especially with activities relating to research and development such as Product
and Process Oriented Research and Development (PPORD) and SR&D substances.
Nevertheless, they do support the publication of names as long as there is a provision to
protect confidentiality where appropriate or provide exemptions, this specific provision to
the measure is also supported by a group of industry representatives and one trade
association. A Member State Competent Authority who is in support of the measure
indicated that the measure would facilitate communication between submitters and the
supply chain, so long as the names were made in direct relation to the submitted
classification and labelling, else there would be less added value to publishing submitter’s
names.
Overall the majority of stakeholders against the measure cite confidentiality reasons. For
example and in line with the above concern regarding research and development substances,
an industry association explained that the publication of a notifiers name against substances
could imply the research and development portfolio of the notifier, which is considered
confidential business information and its indirect publication could discourage innovation.
Furthermore, one trade association, one public authority and one Member State Competent
Authority all suggested that there would be little added benefit or limited usage to this
measure, which one trade association suggesting it would come with additional IT costs that
could otherwise be spent on more effective measures.
A Public Authority recommended to simply publish the identity of the individual data
submitter where groups have agreed on single classifications, because the requirement of
every member would involve significant overall investments on their behalf.
#3: Require notifiers with classifications that diverge from the entry agreed by the
majority of notifiers to update their notifications with a justification for any divergence
in classification
Stakeholders were largely in support of this measure but provided further suggestions to
focus on. Two Member State Competent Authorities agreed that it is important to address
the legitimate differences such as the physical state or impurity/additive profile of a
substance and its influence on classification and labelling and supports the making available
of contextual information. Furthermore, in cases where there are legitimate reasons for
deviation that results in a more stringent classification, then the visibility of data sources
should be considered, because if outlier classifications are added via a drop-down menu,
then they may been deemed of lower reliability. It is noted however that the self-
classification by industry may be correct and more stringent than the harmonised
classification because Member States may not have the resources to update the harmonised
classification (example environmental classification of some cobalt compounds). It was also
suggested that the registrant may not classify based on absence of data, where a notifier may
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have data resulting in classification. Therefore, the approach should be clear to the user of
the inventory and the consequences explained.
Of the stakeholders that were unsupportive of the measure, the question of value in
providing these justifications was raised. A Public Authority indicated that ECHA would
not have the resources or information to decide what represents a good or bad justification.
One Member State is of the opinion that before making any new requirements, industry
should wait for the new version of ECHA database to be published. Additionally, one
industry association believes that the usefulness of this measure depends on the percentage
of substances affected and that other higher impact measures should be prioritised. Other
suggestions for improvements to the C&L Inventory include:
Alignment of new entries:
 A Trade Association has suggested a simple system to improve the alignment of new
entries with existing ones could be of benefit for new notifications e.g. a comparable
approach to REACH-registrations and the stricter technical implementation of the
one substance one assessment principle. With that, in practice, a new notifier could
only join an existing group of notifiers and accept their C&L-entry or opt-out. For
an opt-out there could be a pull-down-menu with the most common reasons for
divergences (e.g. impurity, additive or other data), from which they could pick and
which would then be visible in the public CLI.
Quality Control:
 A Trade Association has also suggested that quality could be improved by letting
users of the CLI act as reviewers e.g. a correction button could be installed into the
CLI directly and if the user disagrees with a specific entry, he could flag it to ECHA
and/or the notifier. To avoid abuse of this system, only registered users would get
the role as reviewers.
 Three Industry representatives have supported the implementation of some simple
validation rules for new notifications. An Industry Association has also commented
on the quality of notifications and the need for this to be assessed. They have
proposed to work along the modalities used in the Horizon Europe Framework,
where the Commission has established a system where participants interested in
joining a call for projects could give their availability without naming the existing
consortia, and the consortia get a notification and can decide to reply. In other words,
the system allows people to get in contact without disclosing identities. Something
similar could be set up:
o The tool could include a possibility for registrants to click on an existing
notification to indicate that they would like to discuss/address the
divergences;
o The notifiers behind those notifications get an automatic alert via ECHA and
they can decide to get in contact with consortia that would like to address the
divergency;
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o This could be combined with a flagging system to publicly display which
notifications have been challenged, regardless of whether they have accepted
or not to reply to the request for discussion;
o To avoid misuse of this system, the flag could be implemented if raised by
the notifiers with the majority of aligned notifications. In other words,
majority groups have the possibility to publicly flag problematic minority
positions, not the opposite.
 One Industry Association has suggested that obvious errors in the Classification and
Labelling Inventory should be corrected or deleted directly by ECHA. If there are
legal reasons to the contrary, ECHA could contact the respective notifier in order to
initiate a correction, as only ECHA has the necessary information available.
Furthermore, entries that are not updated any more as the notifying companies do
not exist any longer, or respective products are not on the market anymore, should
systematically be deleted or inactivated. An easy-to-use process to flag obsolete
entries should be established.
Data download options:
 One Industry Association expressed concern regarding the proposal to make every
part of the Inventory available to be freely downloadable in a structured re-usable
format. They suggested that such provision of data can only take place if there is no
link or connection between the information and the data of the respective notifiers.
Otherwise it will provide a full overview of the portfolio of those companies that
notified to the Classification and Labelling inventory, including those substances
that are manufactured or imported for the purposes of Scientific R&D (SR&D) or
product and process oriented research and development (PPORD) and which are
exempted from registration under REACH. This means that confidential business
information would be revealed by ECHA and would be available for anyone to see.
Notifiers dashboard:
 One Industry Association has highlighted the need for companies to have an
overview of their notifications, access them, and do modifications in bulk, update
when necessary, etc. This could be achieved via a notifiers dashboard.
Consensus classification and labelling:
 One Member State Competent Authority has noted that the document defines the
consensus classification and the consensus labelling as the most consistent
groupings of classification and of labelling data. The word consensus may suggest
that all the notifiers agreed to the same classification. Therefore, some other wording
is suggested such as “dominant” or “majority” unless there is real consensus. It is
also unclear whether “consensus” is based on individual hazard classes or overall
classification. A minimum level (%) should be considered to justify including a
“consensus” classification.
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COMPARISON OF THE MEASURES, REGARDING THEIR RESPECTIVE IMPACT.
Economic impacts
Administrative burden on businesses and public authorities:
All policy measures would lead to increased administrative costs on duty holders who use
substances that meet the classification for one or more of the hazards and are required to
classify them accordingly, and who have the obligation to notify these classifications to the
Classification and Labelling Inventory. Under policy measure #4, notifiers would need to
provide contact details in the inventory or submit confidentiality requests. This policy
measure presents the lowest administrative burden on businesses and is expected to lead to
a small, annualised cost saving of €1.74 million due to time saved by users of the inventory
in finding the relevant information. Policy measure #6 and #5 are also expected to lead to a
small, annualised cost saving of up to €1.79 million, or an annualised cost of 0.36 million,
depending on the effectiveness of the policy measure. Policy measure #3 would lead to the
greatest increase in administrative costs, which are estimated to be approximately €7 million
to – €7.5 million of annualised cost.
Under all policy measures, ECHA would be required to divert resources from other
priorities, such as the ongoing re-design of the inventory. The need for resources would be
highest in policy option #6 and #3, followed by #4 and #5.
Impacts on SMEs:
Under policy measure #6 SMEs are expected to benefit from the time saved spent trying to
find relevant information in the Classification and Labelling Inventory and could see a
subsequent increase in their competitiveness in the long-term. Under policy measure #4, it
is expected that SMEs will benefit from the publication of notifier contact details more than
larger companies, as it is expected that SMEs are less likely to notify as a group. Policy
measure #3 is expected to be disproportionately felt amongst SMEs, which in turn may
negatively impact the competitiveness of SMEs, although there is some uncertainty as
information on the number of diverging classifications per SME and large enterprise was
not available.
Sectoral competitiveness, trade and investment flows:
All policy measures aim to harmonise classifications and improve the quality of the
Classification and Labelling Inventory data, which in turn will benefit all businesses and
increase competitiveness. They are therefore expected to have a positive impact on
sectoral competitiveness.
Social and environmental impacts
The three measures are expected to have positive impact on human health and the
environment from the provision of more accurate information on human health and
environmental hazards of classified substances. This is turn would lead to more appropriate
workplace risk management measures being implemented and more accurate information
communicated down the supply chain and to end-users. However, these impacts would be
324
indirect and therefore their magnitude is not possible to quantify. A weak positive impact is
expected on employment levels from the increased regulatory requirements.
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Annex 12 – Hazard labelling
CONTEXT OF HAZARD LABELLING
Labels provide essential information on safety to chemicals users (both consumers and
workers). The compulsory labelling of hazardous chemicals is the most important element
in CLP to communicate this information. The label includes essential information on the
potential harmful effects on people and/or on the environment that could be caused by a
specific chemical; in addition, it includes information on how to store, dispose and use the
chemical safely, as well as information on how to react in case of poisoning or accidental
exposure. They also facilitate emergency health response by medical staff in case of
exposure or intoxication. Where applicable, they provide contact information of services
that can provide further assistances (Poison centres).
Since the introduction of CLP labels are based on the United Nations’ Globally Harmonized
System of Classification and Labelling of chemicals (GHS250
). At the same time, the CLP
Regulation retains some of the labelling requirements taken over from former legislation on
chemicals251
, such as the small packaging exemptions. In order to accommodate certain
hazard information not yet covered by the GHS, as well as further label elements that are
required by other EU legislation, CLP introduces also the concept of “supplemental
information” to be put on the label.
CLP labels play an important role to ensure the free movement of chemicals in the single
market but also on a global basis: alignment between CLP and GHS ensures reduced
compliance costs, as industry can use the same classification and labelling principles when
exporting chemicals, thereby increasing the competitiveness of EU industry and
international trade of goods.
According to CLP, labelling of hazardous substances and mixtures must contain the
following relevant information, as set out in Article 17 and detailed further in Articles 18 to
28:
 Name, address and telephone number of the supplier(s);
 Product identifiers (i.e. name of the substance or mixture and/or identification
number);
 Nominal quantity of the substance or mixture in the package made available to the
general public (unless specified elsewhere on the package);
 Hazard pictograms (graphics that combine symbols and other elements to denote the
type(s) of hazard associated with a chemical);
250
See UNECE, About GHS, https://unece.org/about-ghs
251
Such as the Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and
administrative provisions relating to the classification, packaging and labelling of dangerous substances, OJ
196, 16.8.1967, p. 1–98 (http://data.europa.eu/eli/dir/1967/548/oj) or Directive 1999/45/EC of the European
Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and
administrative provisions of the Member States relating to the classification, packaging and labelling of
dangerous preparations, OJ L 200, 30.7.1999, p. 1–68 (http://data.europa.eu/eli/dir/1999/45/oj)
326
 Hazard statements (a set of standardised phrases about the hazards of chemical
substances and mixtures);
 Precautionary statements (a set of standardised phrases indicating how the chemical
should be handled to minimise risks to the user, others and the environment);
 Signal words for the level of hazard (‘warning’ or ‘danger’); and
 Supplemental information (as necessary for special cases, including also information
required by other legislation).
Figure 78 provides an example of a typical CLP label.252
Figure 78: Example of a typical CLP label
PROBLEMS AND DRIVERS RELATED TO HAZARD LABELLING
Problems
The chemicals Fitness Check identified some problems in which CLP labelling does not
provide sufficient information, including due to:
frequent non-compliance with the CLP labelling provisions or ambiguity of the text in CLP,
resulting in the absence of a label in certain cases, such as chemicals in very small packaging
252
ECHA guidance on CLP labelling and packaging:
https://echa.europa.eu/documents/10162/2324906/clp_labelling_en.pdf/89628d94-573a-4024-86cc-
0b4052a74d65
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(e.g. writing instruments containing hazardous inks), chemicals supplied to consumers in
bulk (e.g. fuel for cars) or chemicals placed on the market for self-refill (e.g. detergents),
inefficient hazard communication resulting from a limited readability of the labels, for
example due to the amount of information to be affixed on the label, or a small font size, or
chemical names that are not meaningful to consumers,
insufficient compliance and unnecessary administrative burden (in particular for SMEs)
leading to poor application of labelling rules such as absence of CLP labelling in cases
where the obligations are clear (i.e. other than the cases listed above) and leading to a limited
use of fold out labels, thus not exploiting the full benefits of the single market.
The above problems can directly harm public health or the environment since consumers or
workers could be exposed to hazardous chemicals in the absence of the required safety
information (for instance the label can inform on the need to use of gloves for a corrosive
substance or how to correctly dispose a chemical that is toxic to the aquatic environment).
The insufficient level of compliance can also have negative effects on the internal market
competitiveness since non-compliant economic operators could have undue competitive
advantages versus compliant companies (e.g. better market perception due to the absence
of CLP label and pictograms, lower internal costs for labelling etc.). At the same time, the
lack of some information on consumer goods affects the consumers’ ability to make
informed choices.
There is evidence showing that the size of the problem is related to the level of non-
compliance with the CLP labelling requirements. The evidence reported below is the result
of European enforcement projects carried out by several EU countries under the
coordination of the European Chemical Agency (see ECHA FORUM website for additional
information253
); the following quantitative data on compliance levels are available:
2019 European Chemicals Agency FORUM Report on the Pilot project on cooperation
with customs in enforcement of REACH restrictions and CLP labelling254. Compliance
with CLP labelling duties was checked for 150 products in 9 EU countries, 107 of the
inspected products (corresponding to 71% non-compliance rate) had labelling issues. The
most common violation was the absence of the use of national language on the label,
followed by wrong or absent pictograms and signal words, and by the absence of a CLP
label altogether.
2018 European Chemicals Agency FORUM REF-6 Project Report Classification and
labelling of mixtures255. The Forum conducted the REF-6 enforcement project that focused
on controlling CLP duties. 27 EU and EEA countries and Switzerland reported on the results
of inspections. The project checked the hazard labels of mixtures for compliance with CLP.
In total, 1,732 inspections were conducted and 3,189 mixture labels were checked. 1,067 of
253
See ECHA FORUM https://echa.europa.eu/about-us/who-we-are/enforcement-forum
254
ECHA FORUM Report on the pilot project on cooperation with customs in enforcement of REACH
restrictions and CLP labelling, Operational Phase: March–November 2019, available at:
https://echa.europa.eu/documents/10162/13555/customs2_project_report_en.pdf/5a2c3795-7ed9-5900-fe28-
540228abc7c1
255
See https://echa.europa.eu/documents/10162/17088/ref-6_project_report_en.pdf/bfa9fc69-fdfd-2f52-bf96-
5174d7e29cf8?t=1576499164990
328
the labelling elements of the checked mixtures, labelling information was missing and/or
had errors or deficiencies (corresponding to 33.5% non-compliance rate).
2018 Sub section Forum REF-6 Project on labelling exemptions (mixtures in small
packaging, fold out labels etc). 17 EU countries conducted checks on 355 mixtures. Despite
the use of fold-out labels, tie-on tags or an outer packaging, in 32.1 % of the checked
mixtures the full labelling information was not provided. For mixtures in small packaging
(below 125 ml) about 10% of the checks found non-compliances and for mixtures in very
small packaging (less than 10 ml) 9 out of 14 mixtures had labelling issues (corresponding
to about 60% non-compliance rate).
These EU enforcement projects found a high level of non-compliance in terms of CLP
labelling (from 33.5% up to 71%). Therefore, in the framework of this Impact Assessment,
it is possible to broadly estimate an average level of non-compliance in terms of CLP
labelling of about 50% of all chemicals placed on the EU market.
Furthermore, the chemicals Fitness Check pointed out that the existing provisions and
requirements do not take into account opportunities offered by digitalisation which could
help reaching consumers more effectively (see Annex XIII on digital label for further
elements).
Additional evidence on the effectiveness of hazard communication via the CLP label was
assessed via two recent large Eurobarometer surveys:
A 2016 Eurobarometer survey on chemicals safety256
indicated that 70% of EU
citizens find information on the hazards of chemicals on the label useful.
However, the 2017 Eurobarometer survey on environment257
also found that less than half
of the respondents (45%) feel well informed about the potential dangers of the chemicals
contained in consumer products.
Therefore, in the framework of this Impact Assessment, it is possible to broadly estimate
that an average level of about 55% EU citizens consider that they are not well informed
about the hazards of the chemicals contained in consumer products.
The above information provides strong evidence on the magnitude of the problem and of its
European dimension. The problems described above are affecting:
Actors that are responsible for implementing the labelling rules;
Consumers and workers using the CLP label to obtain safety information on the
hazards related to a chemical;
Competent authorities in charge of enforcing CLP.
Drivers
The main drivers of the problems in hazard labelling are:
Regulatory failure driver due to poor application of current rules due to complexity of
labelling provisions - Certain CLP labelling requirements are difficult to apply which
256
2016 Special Eurobarometer 456 https://data.europa.eu/euodp/data/dataset/S2111_86_3_456_ENG
257
2017 Special Eurobarometer 468 https://europa.eu/eurobarometer/surveys/detail/2156
329
sometimes results into a failure to label certain chemicals. This concerns in particular
chemicals placed on the market in very small packaging (e.g. writing instruments, lighters,
super glues), chemicals supplied to consumers in bulk (e.g. car or boat fuel at filling
stations). The labelling requirements are also not sufficiently clear for modern sales
practices (e.g. refill of detergents by the consumer).
Market failure driver due to inconsistent hazard communication across the supply chain
- Many companies are placing chemicals on the market in multiple countries and, therefore,
provide the information on the label in a number of different languages. This often results
in very small font sizes (i.e. reducing readability) or making a suboptimal use of novel form
of labelling such as fold out labels. This can result into an inefficient hazard communication
and consumers and, subsequently, workers are not sufficiently informed on the hazards
related to a chemical and/or face difficulties in reading and understanding the content of the
label.
How likely is the problem to persist? / Baseline
The main problems identified above are:
 Consumers and workers do not have sufficient information due to the absence of
CLP labelling for certain chemicals or inefficient communication.
 Insufficient compliance and unnecessary administrative burden.
The rules on classification, labelling and packaging of hazardous chemicals are harmonised
at EU level via the CLP Regulation. Therefore, the above problems will continue to persist
in absence of EU action. In addition, the evidence collected via the 2019 chemicals Fitness
check, 2016 and 2017 Eurobarometer surveys and the European FORUM enforcement
projects clearly indicates a European dimension of the described labelling issues.
Considering the long-term developments and trends, the following paragraphs contain an
assessment of how the problems will persist in the absence of EU policy intervention:
Labelling and packaging issues with chemicals placed on the market for refill – This
refers to a novel practice of offering unpackaged consumer chemicals in stores where the
consumers brings its own reusable container into which the chemical is filled, thus reducing
packaging waste. This practice is already more common for food but this is also introduced
for chemicals, so far mostly detergents and home care products and corresponds to about
2% of total market for those products (about 179,000 t/year). This figure encompasses refill
detergents made available to all users; considering the average range of delivered quantity
per transaction can be estimated to range from 89.5 million to 8.95 million individual sales
per year for refill of chemicals. By 2040 it is expected that this practice will increase up to
over 265,000 t/year accounting for about 132.5 million to 13.25 million individual sales per
year for self-refill of chemicals. Therefore, assuming a rate of non-compliance of 50% for
CLP labelling, it can be assumed that by 2040 from 6.62 to 66.2 million purchases of refill
chemicals will happen in absence of the appropriate labelling information and further
hamper the effectiveness of hazard communication, thus increasing the risk of consequences
for health or the environment. In addition, there is concern that this practice would not only
be limited to chemicals with less severe hazards. Allowing this practice for corrosive
chemicals such as drain cleaners could result in severe accidents, for example, involving
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consumers at the point of sale. However, restricting the refill to less hazardous chemicals
requires modifications in CLP.
Labelling issues with chemicals placed on the market with multi-language labels – The
European Chemicals Agency estimated that on average each chemical is placed on the
market in 5 EU countries. The Agency also determines those Member States where the scale
of the problem is likely to be greatest. Member States with the greatest number of
neighbouring countries such as Germany (9 neighbours), France (8) and Hungry (7) will
likely experience the export and sale of chemicals products to other Member States to a
greater degree than those with fewer borders. Data from the chemicals industry shows that
the trend in sales between Member States has increased steadily from 2009. This suggests
that the number of products sold between Member States is also increasing and highlights
the growing EU market for chemical products. Therefore, the sale of chemical products in
multiple Member State markets is likely to grow, along with the scale of the problem of
poorly readable multilingual labels and high rates of non-compliance with official language
requirements.
Labelling issues with chemicals placed on the market for consumers in bulk (without
packaging) - This concerns mostly fuel for transport purposes purchased at filling stations
and pumped directly into a tank of a vehicle. To a lesser extent, this also concerns the supply
of fuel additives (e.g. “Ad-blue”) and other fluids for use in vehicles. The difference to the
refill scenario described above is that the chemicals are directly pumped into a tank from
where it is not intended to be removed again by the consumer. Therefore, there is a smaller
risk of exposure or accidents, and that unsuitable receptacles are used. This is also not a
novel practice. Currently over 235,578 Kt per year of fuel are placed on the EU market,
considering the significant development of alternative mobility solutions (electric cars), by
2040 it is expected to decrease to less than 100,000 Kt per year. This remains a very
significant quantity of chemicals placed on the market in bulk every year in EU with sub
optimal or no CLP labelling. The current levels of non-compliance vary significantly
between Member States. Some Member States have set up guidelines on how the labelling
requirements are to be applied in those cases (i.e. established a requirement to put the label
on the fuel pump) and in those Member States there are high levels of compliance. Other
Member States have not acted on this and fuel pumps are typically not labelled.
Labelling issues with chemicals placed on the market with small packaging (e.g. writing
instruments, lighters, essential oils). Those products are broadly commercialised and
purchased in the EU: between about 734 to 898 billion units are placed on the EU market
every year. By 2040 this number is expected to slightly increase. Considering a level of non-
compliance of CLP labels of about 50%, from 367 up to 449 billion units of chemicals in
small packaging might be placed on the market every year with sub optimal or no CLP
labelling. The CLP Regulation requires that those items must have the labelling on the
packaging but in practice items like writing instruments using hazardous inks or lighters are
often sold without packaging. Given the parallel objective of reducing packaging waste, a
balanced approach is needed between the need for appropriate hazard communication and
circular economy objectives.
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For labelling issues, it is likely that the size of the problem will increase or at best will
continue to be significant at EU level. Guidance on Labelling258
was first issued in 2011 by
the European Chemicals Agency and has been updated six times. Despite appropriate
guidance documents and multiple updates the above problems continue to be significant.
Therefore, it cannot be expected that guidance will suffice to address the problems.
DESCRIPTION OF POLICY OPTION AND/OR SUB-OPTIONS FOR HAZARD LABELLING
The following policy options have been assessed to facilitate compliance with the CLP
Regulation and to improve the protection of health and the environment.
258
See https://echa.europa.eu/documents/10162/2324906/clp_labelling_en.pdf/89628d94-573a-4024-86cc-
0b4052a74d65
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Table 94: PO2a and PO2b – Hazard communication and labelling
PO2 Hazard communication and labelling
Policy measure Category Description
PO2a Update and prepare guidance
#11 Guidance on
labelling
Soft
regulation
The European Chemicals Agency to update guidance
to clarify the applicability of the CLP Regulation and
the corresponding rules for chemicals supplied:
in very small packaging (e.g. writing instruments);
to consumers in bulk (e.g. fuels);
via refill of containers (e.g. detergents).
PO2b Improving labelling and making it more flexible
#12 Improving
readability
Hard, legally
binding rules
The Commission to amend Section 1.2 Annex I to
introduce general provisions for a minimum font size
and other provisions to improve the readability of the
label, based on current ECHA guidance.
#14 Facilitating
refill sales through
proper labelling
and other related
requirements
Hard, legally
binding rules
The Commission to address the new practice of refill
sales explicitly in the CLP Regulation to provide
clarity to retailers on the applicable rules for labelling,
thus providing flexibility and legal certainty and
boostering a sales method that contributes to circular
economy objectives. To avoid that this leads to an
unacceptable risk for health and the environment by
doing so (e.g. risks of serious incident during the refill
process or later use at home), the practice should be
limited to chemicals with less severe hazards.
#15 Facilitating the
use of fold-out
labels.
Hard, legally
binding rules
The Commission to amend Article 29(1) and section
1.5.1.1 of Annex I of CLP to allow for a broader use
of fold out labels or tie-on tags to increase the
effectiveness of hazard communication whilst
facilitating the free movement of chemicals in the
internal market.
#16 Labelling
exemptions for
chemicals sold in
bulk to consumers
and in very small
packaging
Hard, legally
binding rules
The Commission to amend:
 Article 23 to include a labelling derogation for
chemicals sold in bulk to consumer at filling
station indicating that in such cases a label on
the pump will suffice.
 Article 23 and Annex I Section 1.3 to extend
the current exemption under Article 29 and
Annex I Section 1.5 for the inner packaging of
contents not exceeding 10ml from chemicals
used for scientific R&D or quality control
analysis to all hazardous chemicals that have
less severe hazards (the inner packaging must
be contained within outer packaging that
meets the requirements of Article 17).
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SCREENING AND ASSESSMENT OF THE POTENTIAL MEASURES FOR HAZARD
LABELLING
Description of impacts
The areas of intervention that have been assessed against the policy options are the
following:
Improving label readability
Facilitating refill sales through proper labelling and other related requirements
Facilitating the use of fold-out labels.
Labelling exemption for chemicals sold to consumers in bulk (e.g. fuel at filling stations).
Labelling exemption for chemicals sold in very small packaging (e.g. writing instruments,
lighters, super-glue).
POLICY MEASURE #14: REFILL CHEMICALS
Economic impacts
Next to improvements for health and the environment, policy measure #14 aims at
facilitating the introduction of this rather novel distribution method to support circular
economy objectives and to encourage more actors to exploit business opportunities. An
explicit mentioning of this distribution method in CLP will clarify the rules for how re-fill
chemicals should be labelled, packaged and limit this sales method to chemicals that have
less severe hazards.
Currently, no guidance or legal requirements for the labelling of refill chemicals exist under
the CLP framework. Therefore, chemicals sold this way are at risk of having no or an
incorrect label and not being suitably packaged. Policy measure #14 would reaffirm that
also re-fill chemicals need to comply with the requirements of CLP for labelling and
packaging (e.g. suitable packaging material). There are several options for how compliance
could be achieved. For example, labelling could be provided via stickers that can be applied
to containers brought by consumers, or a copy of the label could be provided with the
receipt. Suitable and properly labelled containers may also need to be provided at the point
of sale at a cost to the supplier. The supplier may be obliged to update labels on containers
brought in by consumers. There are currently no indications that this sales method would
be used for chemicals with more severe hazards, although it can be expected that this would
become practice given the increasing no-packaging trend. Therefore, for action at this point
there should be no or only very limited cost linked to those policy measure.
The chemicals Fitness Check estimated that the average cost of redesigning and modifying
labels to be compliant with CLP was €388 per substance and €475 per mixture. The
chemicals Fitness Check also cites an impact assessment supporting the adoption of GHS
and implementation of CLP, and further work carried out for International Association for
Soaps, Detergents and Maintenance Products (AISE), which estimated the average cost of
re‐designing and modifying labels to be compliant with CLP to be around €300 per
formulation, based on experiences under the Dangerous Preparations Directive. However,
334
for SMEs these figures may be higher as a significant number of companies (11% and 24%
of companies for the cost of classify substances and mixtures respectively) consulted during
the chemicals Fitness Check gave costs between €500 and €1,000 per substance/mixture,
and these companies tended to be SMEs.
Detergents are one of the most common types of re-fill chemicals, with the growth of this
sector being acknowledged in the Commission’s Evaluation of the Detergents
Regulation259
. The Evaluation estimated the one-off cost, per detergent product, of
producing new labels (to comply with the Detergents Regulation) to be between €200 and
€3,000. Based on both estimates, a figure of €1,000 is assumed, which sits at the upper end
of the Fitness Check estimate and the middle of the estimate provided in the Evaluation of
the Detergents Regulation.
RPA et al. (2018) states that there were between 31,500 and 51,500 consumer detergent
products that had to be relabelled as a result of the Detergents Regulation. It was also
estimated that re-fill detergents make up just over 2% of the overall market of detergent
products. Therefore, it is estimated that there are between 630 – 1,030 re-fill products on
the EU market. Considering an assumed rate of non-compliance with the CLP label of 50%,
the estimated amount of re-fill products impacted by the measure is 315-515 re-fill products
on the EU market. This would lead to a total one-off cost of between €315,000 and €515,000
that would be necessary to return to compliance.
RPA et al. (2017a) give a total one-off cost of throwing label stock away of €3.2 million to
€9 million. Applying the estimate of 2% of detergent market being re-fill detergents and a
50% rate of non-compliance gives a cost estimate of €32,000 – €90,000 for throwing re-fill
label stock away. This leads to a total one-off cost of €347,000 – €605,000. However,
changes in the labelling requirements come with transition periods during which existing
stock can be consumed to avoid the disposal of old labels.
In summary ensuring compliance with existing requirements could result in total one-off
cost of €347,000 – €605,000 and recurring costs of €15,500 – €36,000 per year.
Estimates provided earlier assessed the quantity of re-fill detergents sold in the EU to be
approximately 179 million kilograms per year. This figure encompasses re-fill detergents
made available to all end-users. It is expected that a typical sale of re-fill detergent would
range from 2L – 20L, although large quantities would be purchased during business-to-
business sales. This would provide a range of 89.5 million to 8.95 million individual sales
per year. Considering those figures, it can be calculated that the costs for the sellers of re-
fill chemicals to return into compliance are:
Scenario (89.5 million transactions)
One off costs per year and transaction €0.0038 – €0.0067
Recurrent costs per year and transaction €0.00017 – €0.0004
Scenario (8.95 million transactions)
 One off costs per year and transaction €0.038 – €0.067
 Recurrent costs per year and transaction €0.0017 – €0.004
259
RPA et al. (2018) Evaluation of the Detergents Regulation
335
In the highest range the increase of costs due to one off and recurrent costs is expected to
be less than €0.07 per transaction (only the first year), in the following years the recurring
costs are expected to be less than €0.004 per transaction. Considering the relatively higher
market price for refill products compared to the traditional products it is expected that the
estimated increase will have very limited impact on businesses.
A negative impact on market size and profitability could only be postulated for the new
restriction of refill sales for chemicals with more severe hazards. However, as this market
currently does not seem to have developed yet, such cost should be minor and not
significant. At the same time, an improved legal framework may offer business
opportunities.
For the reasons outlined above, there should be no noteworthy impact on the operation of
SMEs unless they are currently not complying with the existing rules.
Policy measure #14 should not have a noteworthy impact on consumers and households
price of consumer goods. The measure should not place additional costs on suppliers of
refill chemicals in ensuring their products are appropriately labelled and packaged, unless
they are currently not complying with the existing rules. Cost to return into compliance may
be borne by the supplier, or alternatively they may be passed onto consumers through
increased price of consumer goods. The resulting impact on the price of consumer goods
cannot be assessed at this stage since it will depend on business decisions. Nevertheless, the
additional cost per transaction has been estimated to be rather small (less than €0.07 per
transaction only the first year, less than €0,004 per transaction in the following years).
There is currently a perceived lack of clarity on the labelling obligations for refill chemicals
under CLP. Therefore, enforcement activities in this area are not likely to be high. With #14
the supply of refill chemicals may become an area in need of enforcement. Consequently,
enforcement cost of public authorities is expected to increase slightly under policy
measure #14. The ECHA (2019f) REACH-EN‐FORCE‐6 (REF 6) project on classification
and labelling of mixtures carried out 85 inspections as part of an optional module on rules
applicable to Liquid Laundry Detergent Capsules (LLDC). An enforcement project of
similar magnitude would be likely to be sufficient for enforcing the rules for refill chemicals.
Therefore, the number of inspections carried out on Liquid Laundry Detergent Capsules is
a proxy to estimate the cost of enforcement of re-fill chemicals. This gives a recurring cost
of €74,715 (85 x €879). It is not expected that a specific enforcement project on refill
chemicals would occur every year and, therefore, the annual cost would be even lower (a
factor 3 is applied providing a cost of €25,000 per year per enforcement project).
Policy measure #14 is expected to have a positive impact on the functioning of the internal
market and competitiveness. It will clarify the applicable rules for refill chemicals, which
will help ensure that all Member States take the same approach regarding compliance of
refill chemicals with CLP. This is expected to help level the playing field for businesses
across the EU by ensuring they all incur the same (unit) compliance costs.
Table 95: Comparison of impacts
Impact
Category
Impact Positive or
negative
Direct or
indirect
Monetised
Impact
One off or
recurrent
Conduct of
Business
Labelling
Costs
(-) Direct
Annual
recurring
Recurrent
and one off
336
costs
(disposing of
old label
stock):
€7,500 –
€21,000
One-off cost
(re-labelling
disposing of
old label
stock) of
€347,000 to
€605,000.
Annual
recurring
cost (re-
labelling):
€8,000 to
€15,000
Packaging
Cost
(-) Direct Negligible Recurrent
Impact on
market size
(-) Indirect Negligible Recurrent
Public
Authority
Costs
Enforcement
Costs
(-) Direct
Approx.
€25,000 per
enforcement
project
Recurrent
Functioning
of the
Internal
Market and
Competition
Level of
Enforcement
across
Member
States
(+) Indirect
Not
quantified
Recurrent
Position of
SMEs
Operation of
SMEs
(-) Indirect
Not
quantified
Recurrent
Consumers
and
Households
Price of
Consumer
Goods
(-) Indirect
Not
quantified
Recurrent
Environmental impacts
Currently there is no guidance or legal requirements that deals specifically with refill
chemicals Therefore these chemicals are often not labelled or labelled incorrectly (about
one out of two refill chemicals are expected to have no or insufficient hazard information)
and wrongly packaged. This poses risks for to the environment as consumers and workers
are not provided with information on the environmental hazards of the products they are
purchasing, e.g. on how to properly dispose them. Policy measure #14 aim to ensure that
337
suppliers of refill chemicals label and package them correctly. Therefore, this will have a
significant positive impact on the protection of the environment.
Policy measure #14 is expected to have a slightly negative impact on resource use, as they
foresee the requirement for suppliers of refill chemicals to ensure their products are
appropriately labelled and packaged. This means suppliers of refill chemicals who supply
labels, will increase resource use and packaging waste, if they are not in compliance yet.
Estimates provided earlier assessed the quantity of refill detergents sold in the EU to be
approximately 179 million kilograms and policy measure #14 could result in impacting
about 45 to 4.5 million transactions every year This figure encompasses refill detergents
made available to all end-users, consumers and workers. At the same time, refill practices
are likely to have environmental benefits due to the reuse of packaging and related reduction
of resources needed to produce new packaging. It could be argued that the benefits of
reusing a packaging can offset the impacts related to the use of resources to produce new
CLP compliant labels.
Table 96: Environmental impacts
Impact
Category
Impact Positive or
negative
Direct or
indirect
Monetised
Impacts
One off or
recurrent
Sustainable
consumptio
n and
production
Impact on
Resource
Use
(neutral) Indirect
Not
quantified
Recurrent
Impact on
the
protection of
the
environment
(+) Indirect
Not
quantified
Recurrent
Social impacts
No guidance or legal requirements for the labelling of refill chemicals is currently provided.
Therefore, these refill chemicals are often not labelled or labelled incorrectly and not safely
packaged. This negatively affects public health and safety and health systems as
consumers and workers are not provided with information on the human health hazards of
the products they are purchasing and using. The policy measures could result in providing
the necessary information on safety of a high number of hazardous chemicals (up to 4.5
million products placed on the market every year). Policy measure #14 aims to ensure that
suppliers of refill chemicals label and package correctly. Therefore, the policy measure will
have a positive impact on the protection of human health, but the quantification is
problematic and was not quantified in terms of public health.
Policy measure #14 is expected to have a slightly positive impact on employment levels in
the refill sector. Making the existing requirements explicit will provide legal certainty to
this novel sector and likely provide a more level playing field for actors. This is likely to
encourage more businesses to engage in the refill sector, also beyond the detergents sector
that is currently starting to exploit this option.
338
Policy measure #14 is likely to have a slightly positive impact on the number of public
authority jobs, as clearer labelling rules for re-fill chemicals will lead to a new area
requiring enforcement, which may increase the number of enforcement officers required.
Table 97: Social impacts
Impact
Category
Impact Positive or
negative
Direct or
indirect
Monetised
impacts
One off or
recurrent
Public
health and
safety and
health
systems
Impact on
the
protection of
human health
(+) Direct
Not
quantified
Recurrent
Employmen
t
Impact on
industry jobs
in the re-fill
chemical
sector
(+) Indirect
Not
quantified
Recurrent
Impact on
public
authority
jobs
(+) Indirect
Not
quantified
Recurrent
A summary of the costs and benefits of policy measure #14 are provided below.
Summary of cost and benefits of policy measure #14
Costs - businesses
Total one-off costs over a 20-year period 347,000 – 605,000 (mid-
estimate: 476,000)
Recurring costs every 1 year 15,500 – 36,000 (mid-
estimate: 25,750)
Total recurring costs over a 20-year period 294,500 – 684,000 (mid-
estimate: 489,250)
PV of one-off costs (20 years; 3%) 466,477 – 813,310 (mid-
estimate: 639,894)
PV of one-off costs (20 years; 3%) (annualized) 23,324 – 40,666 (mid-
estimate: 31,995)
PV of recurring costs (20 years; 3%) 395,901 – 919,511 (mid-
estimate: 657,706)
Total PV – costs - businesses 862,378 – 1,732,821 (mid-
estimate: 1,297,599)
Costs – public authorities
Total one-off costs over a 20-year period -
Recurring costs every 1 year 25,000
Total recurring costs over a 20-year period 475,000
PV of one-off costs (20 years; 3%) -
PV of recurring costs (20 years; 3%) 638,549
339
Total PV – costs – public authorities -
Total PV cost of policy measure #14 1,500,927 – 2,371,370 (mid-
estimate: 1,936,148)
Benefits (cost savings) - businesses -
PV benefits - businesses -
Benefits (cost savings) – public authorities -
PV – benefits – public authorities -
Benefits - society -
PV - benefits - society -
Total OV - benefits -
Net Present Value - NPV (PV benefits – PV costs) -1,500,927 – -2,371,370
(mid-estimate: -1,936,148)
A summary of the present value costs (3% discount) for policy measure #14 are provided
below.
Summary of costs and benefits (PV; 20 years; 3%) of policy measure #14 by type
Costs
Businesses Administrations Society
Direct adjustment
costs
- - -
Direct
administrative costs
€1,500,927 –
€2,371,370 (mid-
estimate: €1,936,148)
€638,549 -
Direct regulatory
fees and charges
- - -
Indirect costs - - -
Benefits
Description Businesses Administrations Society
Direct benefits
- - -
POLICY MEASURE #15: FOLD-OUT LABELS
Policy measure #15 would allow the use of fold-out labels also for chemicals with normal
size packaging (currently this applies only to small packaging and packaging in special
forms). Currently, suppliers of chemicals delivered into multiple Member States put several
languages on the same label to exploit economies of scale. This often leads to a small font
size, often becoming almost illegible, in particular for consumers and workers with visual
impairments. Furthermore, this also leads to overloaded labels, where consumers experience
difficulties in finding the information relevant to them. If suppliers of chemicals in multiple
Member States want to overcome this, they would currently have to produce containers with
different labels for the various markets. Considering that policy measure #12 would
introduce minimum requirements, the problem would be further aggravated and could lead
to competitive disadvantages. In turn allowing the use of fold-out labels also for chemicals
340
with normal packaging sizes, would compensate the impact of policy measure #12 and allow
the use of multilingual labels whilst improving the readability of the label in line with policy
measure #12. There is to same degree a trade-off between the inconvenience of a fold-out
label and the improvement of the readability, so overall the impact on the safety level is
probably neutral. Improvements in the technology and reliability of fold-out labels give
sufficient assurance that they are equally reliable as classical labels and is now acceptable
not only in exceptional cases. The possibility of using more language versions could also
be used to include languages which are widely spoken in a Member State but not official
languages. This could cater in particular communities with a migration background and may
provide business opportunities.
Figure 79: Example of a multi-lingual fold-out label
Source: European Chemicals Agency guidance on CLP labelling
Options to extend the scope of multilingual fold-out labels have been previously discussed
at CARACAL260
where it was also suggested to include certain related quality requirements
either in Annex II of CLP or in ECHA guidance to ensure the quality, readability and
accessibility of information (as now included in policy measure #12). While the majority of
Member States were in favour of extending the scope of multi-lingual fold-out labels, some
proposed certain restrictions should be considered, including minimum readability
requirements on top of those in the ECHA guidance.
Economic impacts
For estimating the Conduct of Business cost it is important to note that policy measure #15
will not mandate the use of a fold-out label. It will only provide an option to use it.
Therefore, the use of a fold-out label versus a standard label would be a voluntary business
choice of the relevant supplier. It is likely that suppliers will only opt for a fold-out label
where it actually is economically beneficial for them. The following information about cost
is, therefore, informative but actually, it can be assumed that the economic benefits of using
fold-out labels will practically always outweigh the associated cost.
260
See CA/05/2015, CA/51/2015, CASG-LP/03/2015
341
An initial cost for transitioning to fold-out labels would be incurred. The chemicals Fitness
Check estimates the average cost of re-labelling each substance and mixture to be €388 and
€475 respectively. Due to the increased size and material use of fold-out labels as opposed
to standard on-pack labels, the cost of producing fold-out labels is likely to be higher. In the
chemicals Fitness Check, a significant number of companies indicated re-labelling costs of
between €500 - €1,000 per product, which is considered to be more likely to be
representative of the cost of producing fold-out labels. The number of products that are sold
across Member States is not known so it is not possible to quantify the total cost of
transitioning to fold-out labels.
The use of fold-out labels could provide significant economic advantages: the greater the
maximum number of languages allowed, the higher the saving in labelling costs. Assuming
a maximum number of six languages to be affixed, the maximum saving in labelling cost
would equate to the need to only produce one fold-out label, rather than 6 on-pack labels.
Taking the re-labelling costs represented in the Fitness Check, the average cost of producing
6 on-pack labels would be €2,328 – €2,850 (depending on whether they are for substance
or mixtures), whereas the cost of producing a fold-out label has been estimated to be in the
region of €500 to €1,000. This represents a long-term cost saving of between €1,328 –
€2,350 per product.
Information from poison centre notifications suggest that, on average, hazardous mixtures
are supplied to five Member States. Based on the calculations above, this would mean each
company on average would have a cost saving of €1,375 to €1,875 (5 x €475 minus €500
to €1,000).
Consultation with a large supplier of chemical products indicated that their most widely sold
products require 15-16 different labels on average. For large enterprises, this is likely to be
representative of most products in their portfolios, whilst the estimate of five different labels
provided above is likely to be more representative of SME, as most are likely to sell in fewer
Member States. If wider use of fold-out labels was introduced, with a maximum number of
six languages per label, large enterprises could see the number of different labels required
to place each product on the market reduced to 3, while SMEs could use a single label per
product. This would lead to a cost saving of €4,125 – €5,625 (15 x €475 minus (€500 to
€1,000 x 3)).
Taking the detergents industry as a case study, the Evaluation of the Detergents Regulation
provides an estimate of the number of large enterprises and SMEs and the number of
consumer detergent formulations each places on the market on average. This data has been
used to calculate the cost saving per enterprises from wider use of multilingual labels and
the total cost for all enterprises.
Table 98: Savings estimations based on broader use of fold out labels
342
Enterprise
Type
No.
of
Enterprises
No.
of
Consumer
Detergent
Formulation
per
Enterprise
Average
No.
of
Labels
Required
per
Product
Average
No.
of
multilingual
labels
Required
per
Product
Cost
Saving
per
Product
Total
Cost
Saving
per
Enterprise
Total
Cost
Saving
Annualised
Cost
Saving
Large
enterprise
50 150-
250
15 3 €4,125
–
€5,625
€618,750 –
€1,406,250
€30,937,500
–
€70,312,500
€11,834,000
–
€26,895,000
SME 600
–
650
40 – 60 5 1 €1,375
–
€1,875
€55,000 –
€112,500
€33,000,000
–
€73,125,000
€12,623,000
–
€27,970,000
Total 650
-
700
31,500
–
51,500
- - - €64,000,000
–
€144,000,000
€24,000,000
–
€55,000,000
Using the detergents sector as an example, multilingual labels with a maximum of five
languages would require large enterprises to use three different labels required for each
product on the market instead of 15, while SMEs could use one label instead of five (one
per product). This is estimated to reduce costs savings (annualised) for the detergents sector
only by €24,000,000 to €55,000,000. About half of those savings are related to SMEs
(€12,623,000 – €27,970,000).
The baseline information show that intra-EU sales of chemical products are in the hundreds
of billions of Euros and represent the majority of total sales in the EU. Therefore, it can be
assumed that a large number of products are sold across multiple Member States and would
benefit from wider use of fold-out labels. The cost savings are thus expected to be significant
and a strong positive impact on administrative costs to business is likely.
Data from Eurostat261
shows that across the EU-27, on average 56% of intra-EU exports of
goods for each Member State were supplied to their three largest EU partners. For
Luxembourg and Portugal, 71% and 72% of their intra-EU exports of goods respectively
are to their three largest EU partners, while Germany exports only 38% of its intra-EU goods
to its three largest EU partners. This highlights that a fold-out label accommodating up to
five languages would cover the majority of each Member State’s intra-EU traded goods.
No change in public authority costs enforcement costs is expected under policy measure
#15 as enforcement is already carried out to check compliance of fold-out labels and
compliance of labels with official language requirements, for example as part of various
enforcement projects of the European Chemicals Agency.
Policy measure #15 is expected to have a positive impact on the functioning of the internal
market and competition as it will establish readability criteria on labels and clearer rules
on multilingual labels and help ensure their implementation is harmonised across all
Members States. Allowing wider use of multilingual labels will also level of the cost of
261
See https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Intra-EU_trade_in_goods_-
_main_features#Intra-EU_trade_in_goods_by_Member_State
343
business across the EU by reducing the administrative burden on companies, which will
have a positive impact on competitiveness of EU businesses and promote the free movement
of goods.
The wider user of fold-out multilingual labels would bring the greatest benefit to companies
operating across many Member States, which are typically large companies. The position
of SME operation was discussed during a 2014 workshop organised by the European
Commission on the safe use of chemicals by SMEs. This addressed the challenges related
to the implementation of CLP by SMEs: The restricted use of multi-lingual fold-out labels
was mentioned by stakeholders as an important challenge for SMEs because of the high
administrative burden posed by the frequent re-labelling required when distributing a
product in multiple Member States. This indicates that wider use of fold-out labels would
also bring significant benefit to SMEs: about half of total savings are related to SMEs
(€12,623,000 – €27,970,000).
As regards to consumers and households price of consumer goods, consumers currently
are confronted with the high levels of non-compliance with the requirement under Article
17(2) that labels “shall be written in the official language(s) of the Member State(s) where
the substance or mixture is placed on the market” (see explanations above). Although the
reason for the infringements of Article 17(2) are not known, this may be in part due to the
cost of re-labelling a product sold in multiple Member States being perceived as too high.
Wider use of fold-out multilingual labels would reduce label costs, which is expected to
make it easier for companies to comply with the requirement under Article 17(2). Greater
compliance with official language requirements coupled with the establishment of minimum
readability criteria will improve communication of hazard information to consumers and
empower EU consumers and professional users through better access to more relevant and
understandable product information, leading to more informed decision making on the
purchase and use of chemical products.
Table 99: Economic impacts
Impact
Category
Impact Positive or
negative
Direct or
indirect
Monetised
Impact
One off or
recurrent
Conduct of
Business
Labelling
Costs
(+) Direct
€24-55
million
annualised
Recurrent
Public
Authority
Costs
Enforcement
Costs
(o) Direct
Not
quantified
Recurrent
Functioning
of the
Internal
Market and
Competition
Level of
Enforcement
across
Member
States
(+) Indirect
Not
quantified
Recurrent
Free
Movement of
Goods
(+) Indirect
Not
quantified
Recurrent
Position of
SMEs
Operation of
SMEs
(+) Direct
€12-27.9
million
Recurrent
344
Consumers
and
Households
Consumer
Information,
Knowledge,
Trust or
Protection
(+) Direct
Not
quantified
Recurrent
Environmental impacts
Greater use of fold-out multilingual labels coupled with improved readability criteria
improve the protection of environment. This is because that would allow a greater number
of languages to be provided on product labels, which would increase the comprehension
rate of labels. Multilingual labels are important in ensuring that purchasers of products on-
line from other Member States, and EU workers and citizens in Member States other than
their own, receive information on environmental hazards of products in their native
language. Policy measure #15 is expected to have a neutral impact on resource use. Fold-
out labels consist of multiple pages and subsequently use more paper in their manufacture
than on-pack labels. However, as discussed below, fold-out labels improve planning and
reduce the amount of surplus labelling and packaging stock.
Greater use of fold-out labels is expected to lead to a reduction in labelling and packaging
waste, as on-pack labels would not have to be re-designed when products are sold in
multiple Member States. Greater flexibility in planning and logistics resulting from a single
label, as opposed to multiple labels, would result in less labelling and packaging being
scrapped. At the same time, a fold-out label can also replace several traditional labels. At
previous discussions at CARACAL in 2015 262
on the quality and design of fold-out labels,
there was agreement on the importance of ensuring sufficient quality of fold-out labels, with
the exact manner in which the quality and robustness is ensured left to the duty holder. It
was agreed that guidance should state that the fold-out label should be durable (e.g. by using
plasticised pages) and that it should be attached to the packaging in a robust way. Therefore,
some level of plasticisation of fold-out labels would be required, which would increase
plastic waste. It should also be noted that fold-out labels consist of multiple pages and
subsequently will use more paper in their manufacture. Overall, policy measure #15 is
expected to have a neutral or small positive impact on labelling and packaging waste.
Table 100: Environmental impacts
Impact
Category
Impact Positive or
negative
Direct or
indirect
Monetised
impacts
One off or
recurrent
Sustainable
consumptio
n and
production
Impact on
Resource
Use
(o) Direct
Not
quantified
Recurrent
Impact on
the
protection of
the
environment
(+) Indirect
Not
quantified
Recurrent
262
European Commission (2015): 18th Meeting of Competent Authorities for REACH and CLP (CARACAL)
– 23 – 24 June 2015 CA/51/2015
345
Waste
production,
generation
and
recycling
Impact on
Labelling
and
Packaging
Waste
(o) Direct
Not
quantified
Recurrent
Social impacts
The impact of the more frequent use of fold-out labels on the public health and safety and
health systems is likely to be positive. During previous discussions at CARACAL, the
value of multilingual labels has been expressed by several group members, due to the
increasing amount of international internet sales and the growing number of workers active
across borders within the EU. Multilingual labels are important in ensuring that purchasers
of products on-line from other Member States, and EU workers and citizens in Member
States other than their own, receive information on the human health hazards of products in
their native language. Greater use of fold-out multilingual labels would allow a greater
number of languages to be provided on product labels, which would increase the
comprehension rate of labels and thereby improve the protection of human health.
Policy measure #15 is unlikely to have implications on employment.
Table 101: Social impacts
Impact
Category
Impact Positive or
negative
Direct or
indirect
Monetised
impacts
One off or
recurrent
Public
health and
safety and
health
systems
Impact on
human health
(+) Direct
Not
quantified
Recurrent
Employmen
t
Impact on
industry and
public
authority
jobs
(o) Indirect
Not
quantified
Recurrent
A summary of the cost and benefits of policy option #15 are presented below.
Summary of cost and benefits of policy measure #15
Costs - businesses
Total one-off costs over a 20-year period €64,000,000 – €144,000,000
(mid-estimate:
€104,000,000)
Recurring costs every 1 year €24,000,000 – €55,000,000
(mid-estimate: €39,500,000)
Total recurring costs over a 20-year period €456,000,000 –
€1,045,000,000 (mid-
estimate: €750,000,000)
346
PV of one-off costs (20 years; 3%) €86,036,106 – €193,581,238
(mid-estimate:
€139,808,672)
PV of one-off costs (20 years; 3%) (annualized) €4,301,805 – €9,679,062
(mid-estimate: €6,990,434)
PV of recurring costs (20 years; 3%) €613,007,253 –
€1,404,808,289 (mid-
estimate: €1,008,907,771)
Total PV – costs - businesses €699,043,359 –
€1,598,389,527 (mid-
estimate: €1,148,716,443)
Costs – public authorities
Total one-off costs over a 20-year period
Recurring costs every 1 year
Total recurring costs over a 20-year period
PV of one-off costs (20 years; 3%)
PV of recurring costs (20 years; 3%)
Total PV – costs – public authorities
Total PV cost of policy measure #15 €699,043,359 –
€1,598,389,527 (mid-
estimate: €1,148,716,443)
Benefits (cost savings) - businesses
PV benefits - businesses
Benefits (cost savings) – public authorities
PV – benefits – public authorities
Benefits - society
PV - benefits - society
Total OV - benefits
Net Present Value - NPV (PV benefits – PV costs) €699,043,359 –
€1,598,389,527 (mid-
estimate: €1,148,716,443)
A summary of the present value costs (3% discount) for policy measure #15 are provided
below.
Summary of costs and benefits (PV; 20 years; 3%) of policy option #14 by type
Costs
Businesses Administrations Society
Direct adjustment
costs
Direct
administrative costs
699,043,359 –
1,598,389,527 (mid-
estimate:
1,148,716,443)
347
Direct regulatory
fees and charges
Indirect costs
Benefits
Description Businesses Administrations Society
Direct benefits
POLICY MEASURE #12: IMPROVING READABILITY
Note: Policy measure #12 is linked but not limited to policy measure #15.
CLP only includes general instructions concerning the formatting of the label. Article 31
only specifies that:
the colour and presentation of any label shall be such that the hazard pictogram stands out
clearly.
The label elements referred to in Article 17(1) shall be clearly and indelibly marked. They
shall stand out clearly from the background and be of such size and spacing as to be easily
read.
Guidance263
by the European Chemicals Agency explains that readability is determined by
the combination of font size, letter spacing, spacing between lines, stroke width, type colour,
typeface, width-height ratio of the letters, the surface of the material and significant contrast
between the print and the background.
Readability has continuously been point for discussion, as highlighted by the chemicals
Fitness Check which found evidence to indicate that labels can become overloaded with
information. That makes it difficult for consumers and workers to focus on essential hazard
and use information, reducing the effectiveness of hazard communication, particularly on
products supplied in small packaging and when multilingual labels are required. It was
found that consumers and workers are often faced with unattractive labels with too much
text in too small font size, in particular in relation to multilingual labels restricts the
comprehensibility of the information displayed.
In the Commission Expert Group on REACH and CLP further suggestions were made to
improve the readability of labels such as grouping information by language, or mandating a
logical order of the languages (e.g. alphabetical).
The unspecific rules also hamper enforcement efforts as different interpretations are
possible e.g. of what “size and spacing as to be easily read” actually means. Despite the
existing guidance, the problem persist, as the guidance is not legally binding. Without
further action, the problem will persist or even increase.
263
Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008, Version 4.2
March 2021, https://echa.europa.eu/documents/10162/2324906/clp_labelling_en.pdf/89628d94-573a-
4024-86cc-0b4052a74d65
348
Policy measure aims to improve the readability of the label, thus improving hazard
communication, by introducing legally binding rules in CLP. To this extent it is possible
Commission to amend Section 1.2 Annex I to introduce general provisions for a minimum
font size and other provisions to improve the readability of the label, based on current ECHA
guidance.
Economic impacts
The impacts of this measure have not been separately assessed but in conjunction with
policy measure 15. As outlined therein, formatting requirements would come together with
allowing a wider use of fold-out labels. However, they would also apply to standard labels.
The aim of CLP is to ensure both a well-functioning single market for chemicals and a high
level of protection of human health and of the environment. To achieve this, information on
the hazards and safe use of chemicals must be effectively communicated to consumers and
end-users of chemical products, the primary vehicle for which is labelling. To ensure the
free circulation of chemicals in the internal market, labelling of chemical products must not
be too onerous or represent an undue administrative burden, and labelling requirements
must be harmonised across the EU and internationally to prevent the need for different labels
for each national market. Setting clearer formatting rules for labels will provide a more level
playing field and limit competition over safety.
Adjusting to a new labelling format would incur initial conduct of business cost. However,
as policy measure 12 is not a stand-alone measure, the cost will occur anyway as a result of
other changes. Potential cost could also be compensated by taking advantage of the wider
possibilities to use fold-out labels. It is not likely that policy measure 12 would have an
impact on the market size.
Public Authority Cost are more likely to decrease because policy measure 12 will facilitate
enforcement with its clear rules. Clear rules also mean that there is less likelihood for non-
compliance.
The functioning of the internal market and competition is likely to improve once policy
measure #12 enters into force. There may be a slightly positive impact due to an improved
level playing field.
SME did not express a particular opinion on policy measure #12.
Price of consumer goods are unlikely to be significantly influenced by policy measure #12.
Table 102: Economic impacts
Impact Category Impact Positive or
negative
Direct or
indirect
Monetised
Impact
One off or
recurrent
Conduct of Business
Labelling Costs (o) Direct Not quantified Recurrent
Impact on
market size
(o) Indirect Not quantified Recurrent
Public Authority
Costs
Enforcement
Costs
(-) Direct Not quantified Recurrent
349
Functioning of the
Internal Market
and Competition
Level of
Enforcement
across Member
States
(+) Indirect Not quantified Recurrent
Position of SMEs
Operation of
SMEs
(-) Indirect Not quantified Recurrent
Consumers and
Households
Price of
Consumer
Goods
(-) Indirect Not quantified Recurrent
Environmental impacts
Labels that are difficult to read pose a threat to the environment, as consumers and workers
may not be able to take note of the use and disposal instructions. In particular if they have
visual impairments. While, it is not possible to quantify this effect, it is likely that improved
readability will have a neutral or slightly positive impact on the environment and resource
use.
Table 103: Environmental impacts
Impact Category Impact Positive or
negative
Direct or
indirect
Monetised
impacts
One off or
recurrent
Sustainable
consumption and
production
Impact on
Resource Use
(o) Direct Not quantified Recurrent
Impact on the
protection of
the
environment
(+) Indirect Not quantified Recurrent
Waste production,
generation and
recycling
Impact on
Labelling and
Packaging
Waste
(o) Direct Not quantified Recurrent
Social impacts
Poorly legible labels negatively affect public health and safety and health systems as
consumers and workers may not be able to take not of information on the human health
hazards of the products they are purchasing and using. In particular when they are having
visual impairments. Policy measure #12 aims to ensure labels are legible. Therefore, the
policy measure will have a positive impact on the protection of human health, but the
quantification is problematic and was not quantified in terms of public health.
Policy measure #12 is unlikely to have a noteworthy impact on employment and equally
unlikely to have a noteworthy impact on the number of public authority jobs.
Table 104: Social impacts
Impact Category Impact Positive or
negative
Direct or
indirect
Monetised
impacts
One off or
recurrent
Public health and
safety and health
systems
Impact on
human health
(+) Direct Not quantified Recurrent
350
Employment
Impact on
industry and
public
authority jobs
(o) Indirect Not quantified Recurrent
POLICY MEASURE #16 CHEMICALS SOLD IN BULK TO CONSUMERS
Note: policy measure #16 includes actions on labelling exemption for chemicals sold in bulk
to consumers and in very small packaging. This chapter only addressed chemicals sold in
bulk to consumers. The labelling exemption for very small packaging is addressed in the
next chapter.
Policy measure #16 grants a derogation from labelling obligations under the CLP
Regulation for chemicals sold in bulk to consumers, such as fuel sold at filling stations. This
concerns cases where the chemical is directly pumped into a receptacle (such as a vehicle’s
fuel tank) from where it is not intended to be removed by the consumer and where the
consumer cannot get in touch with the chemical due to the way the chemical is transferred
(i.e. nozzle entering the receptacle). Under this derogation, it would suffice to provide a
label on the pump for each of the chemicals dispensed via the related nozzles (e.g. one label
for petrol and one label for diesel at a fuel pump).
Economic impacts
Policy measure #16 aims to clarify the rules how unpackaged chemicals supplied in bulk to
consumers should be labelled. While CLP does not discriminate between forms of sale,
currently there is no guidance or dedicated legal requirements for the labelling of
unpackaged chemicals sold to consumers (except for those covered by Article 29(3) which
currently only covers ready mixed cement and concrete in a wet state). Therefore, these
chemicals are often not labelled or labelled incorrectly, also because the current provision
are difficult to apply to such forms of sales given the absence of a packaging. Policy measure
#16 would require suppliers of bulk chemicals to ensure compliance with any specific CLP
labelling requirements. As policy measure #16 represents additional conduct of business
cost for those suppliers that are currently chemicals in bulk to consumers and not complying
to current rules. The assessment of economic impacts below focuses on quantifying the
impacts of fuel labelling as a case study. This is believed to be by far the largest share of the
market but does not quantify the total impacts of labelling all unpackaged chemicals
supplied in bulk (i.e. not including other fluids provided in bulk to consumers such as
“AdBlue”).
A cost-effective option would be providing labelling as an extension to a receipt. However,
this may not be sufficient as consumers do not always choose to take a receipt and in these
instances, consumers would not receive labelling information. Although this could be
combated by removing the option to decline a receipt being issued, this could face backlash
from consumers who are moving away from receipt due to environmental concerns. Instead,
within CARACAL, the provision of a sticker at a fuel pump with the correct label elements
was deemed to represent a sufficient solution, and it would be left to the consumer to take
note of the sticker, or take home a copy of the sticker. It was stated at CARACAL that self-
service filling stations should not be required to verify that every customer uses the sticker
on their jerry can, but they would be required to at least make the sticker available. It is
351
relevant to note that in some Member States it is already obligatory to label the pumps
accordingly.
As of the end of 2018, there were approximately 67,000 filling stations in the EU-27
(FuelsEurope, 2019), the number of individual fuel pumps being several times greater.
A recent impact assessment by the UK Department of Transport (UK DOT, 2019) on the
adoption of standard labels for the type and biofuel content of road transport fuels in
response to the EU's Alternative Fuels Infrastructure Directive (AFID) provides a central
estimate of 239,212 for the number of fuel nozzles in the UK in 2019, based on information
provided by associations from the automotive and fuel industry. The impact assessment
provided a cost range of €0.14 – €1.36 to label a single fuel nozzle, with a mid-point of
€0.75 (estimates converted to Euros and 2021 prices).
As of 2019, the UK had a population of 66,647,112, which is approximately 15% that of the
EU-27 (446,446,444) (Eurostat, 2019). If we use this proportion to extrapolate the number
of fuel nozzles in the UK to give as estimate of the number in the EU, it gives an estimate
of approximately 1,520,000 million fuel nozzles. When dividing this figure of the number
petrol stations in the EU-27 from FuelsEurope, it gives an average of roughly 24 fuel nozzles
per station, which based on 3 nozzles per fuel pump (2 petrol; 1 diesel), would give a figure
of 8 pump per stations on average, which is considered a realistic estimate. 1.6 million fuel
nozzles would give a relabelling cost of €212,800 - €2,067,200 based on the costs provided
above, with a central estimate of €1,200,000. The costs of new fuel nozzle labels are
expected to be one off cost. Following initial labelling, replacement labels would be factored
into maintenance of branding schedules with only marginal additional costs expected.
An additional cost incurred by fuel retailers would be the integration of the labels into their
existing point of sale branding. Estimates form the UK DOT (2019) give a cost of €374 per
fuel station (estimate converted to Euros and 2021 prices), although it notes that smaller
filling stations will spend significantly less and not choose to incorporate labels into existing
branding. Therefore, a median estimate of €155 per fuel station is provided (estimate
converted to Euros and 2021 prices). This would be a cost of €10,385,000, based on 67,000
fuels stations across the EU. However, including the label in existing branding would be a
voluntary business choice, in addition to a simple label that would suffice to comply with
policy measure 16. Therefore, this cost is informative but not relevant for this impact
assessment.
A further cost highlighted by the UK DOT (2019) is the cost of training staff to understand
the labelling information and help answer any queries from fuel pump customers. Using the
time taken for training legal and accounting staff as a proxy for training sales and customer
service occupations, the UK DOT arrived at a central estimate of €16.75 per fuel station
(estimate converted to Euros and 2021 prices). Based on 67,000 fuel stations across the EU,
this would equate to a cost of approximately €1,122,250.
The cost outlined above would only occur in Member States that do not already require a
labelling of the pump and only where multinational chains do not label their pumps anyway
as part of their corporate policy. Furthermore, it needs to be taking into account that policy
measure #16 would not mandate a label per nozzle. Typically, one label of petrol and one
label for diesel on the pump would suffice, independent of the number of actual nozzles per
fuel type. Therefore, those cost estimations constitute a maximum.
352
Public authorities’ enforcement cost are influenced by the fact that there are currently no
dedicated labelling obligations for chemicals sold in bulk to consumers under the CLP
Regulation. Therefore, enforcement activities in this area are currently dependent on
national rules. If labelling obligations are imposed though amendment of the legal text of
the CLP Regulation, the supply of fuels will become an additional area in need of
enforcement in Member States that do not have such rules yet. Consequently, the level of
resources needed by enforcement authorities is expected to increase under policy measure
#16.
The ECHA (2019f) REACH-EN‐FORCE‐6 (REF 6) project on classification and labelling
carried out 194 inspections as part of an option module on exemptions from labelling and
packaging requirements. This optional module targeted mixtures supplied in small
packaging, which have specific labelling rules under CLP. If specific labelling rules for
chemicals sold in bulk to consumers are established, a similar level of enforcement is likely
to be sufficient as that carried out on mixtures supplied in small packaging. Therefore, we
can use the number of inspections carried out on mixtures supplied in small packaging as a
proxy to estimate the cost of enforcement of re-fill chemicals. This gives a recurring cost of
€170,526 (194 x €879 per on-site inspection). It is not expected that a specific enforcement
project on refill chemicals would occur every year and, therefore, the annual cost would be
even lower (a factor 3 is applied providing a cost of approximately €57,000 per year per
enforcement project).
Policy measure #16 is expected to have a positive impact on the functioning of the internal
market and competitiveness. The policy measure aims to clarify rules on the labelling of
chemicals sold in bulk to consumers, which will help ensure that all Member States take the
same approach regarding compliance of bulk chemicals with CLP. This is expected to help
level the playing field for businesses across the EU by ensuring they are all subject to the
same compliance costs. The positive impact is expected to be very weak as the oil sector
(NACE C19.2) is dominated by a few large companies, with the average turnover in 2018
being €562,000,000 (Eurostat, 2018). Therefore, the compliance costs are not expected to
be significant to competition.
Labelling chemicals sold in bulk to consumers is not expected to have a negative impact on
the operation of SME as suppliers of fuel are typically, but not exclusively, large
multinational companies or cooperatives and therefore SMEs are not expected to be
significantly or disproportionately impacted.
Table 105: Economic impacts
Impact
Category
Impact Positive or
negative
Direct or
indirect
Monetised
Impact
One off or
recurrent
Conduct of
Business
Labelling
Costs
(-) Direct
Fuels
One-off cost
of
€11,700,000
–
€13,700,000
One-off
Public
Authority
Costs
Enforcement
Costs
(-) Direct
Approx.
€57,000 per
Recurrent
353
enforcement
project
Functioning
of the
Internal
Market and
Competition
Level of
Enforcement
across
Member
States
(+) Indirect
Not
quantified
Recurrent
Position of
SMEs
Operation of
SMEs
(o) Indirect
Not
quantified
Recurrent
Environmental impact
So far, legal clarity on the labelling of unpackaged chemicals is only provided by Article
29(3) and guidance by the European Chemicals Agency on labelling and packaging related
to that provision. Since no specific provisions exist for fuels and similar cases, these
chemicals are often not labelled or labelled incorrectly. This increases the environmental
impact of such sales as consumers are not provided with information on the environmental
hazards of the products they are purchasing. Policy measure #16 would require all suppliers
of bulk chemicals to ensure they are labelled and packaged correctly. Thereby, policy
measure #16 will have a slightly positive impact on the protection of the environment.
Policy measure #16 is expected to have a neutral impact on sustainable consumption and
resource use, as it foresees the requirement for suppliers of chemicals in bulk to ensure
their products are appropriately labelled and packaged. As this would happen once at the
level of fuel pump, it is not expected to create a noteworthy impact in the resource use and
packaging waste.
354
Table 106: Environmental impacts
Impact
Category
Impact Positive or
negative
Direct or
indirect
Monetised
impacts
One off or
recurrent
Sustainable
consumptio
n and
production
Impact on
Resource
Use
(neutral) Indirect
Not
quantified
Recurrent
Impact on
the
protection of
the
environment
(+) Indirect
Not
quantified
Recurrent
Social impacts
Currently public health and safety and health systems can be negatively affected because
there is no dedicated guidance or legal requirements for the labelling of chemicals sold to
consumers in bulk. Therefore, these chemicals are often not labelled or labelled incorrectly.
This reduces the level of protection for human health as consumers are not provided with
information on the human health hazards of the products they are purchasing.
Policy measure #16 is not likely to have any significant impact on employment levels. The
additional cost of conducting business is expected to be negligible.
A summary of the costs and benefits of introducing labelling for fuels is provided below
Summary of cost and benefits of policy measure #16 (fuel labelling)
Costs - businesses
Total one-off costs over a 20-year period €11,700,000 – €13,700,000
(mid-estimate: €12,700,000)
Recurring costs every 1 year
Total recurring costs over a 20-year period
PV of one-off costs (20 years; 3%) €15,728,476 – €18,417,104
(mid-estimate: €17,072,790)
PV of one-off costs (20 years; 3%) (annualized) €786,424 – €920,855 (mid-
estimate: €853,639)
PV of recurring costs (20 years; 3%)
Total PV – costs - businesses €15,728,476 – €18,417,104
(mid-estimate: €17,072,790)
Costs – public authorities
Total one-off costs over a 20-year period
Recurring costs every 1 year €57,000
Total recurring costs over a 20-year period €1,083,000
PV of one-off costs (20 years; 3%)
PV of recurring costs (20 years; 3%) €1,455,892
PV of recurring costs (20 years; 3%) (annualized) €76,626
Total PV – costs – public authorities
355
Total PV cost of policy measure #16 (fuel labelling) €17,260,994 – €19,949,622
(mid-estimate: €1,455,892)
Benefits (cost savings) - businesses
PV benefits - businesses
Benefits (cost savings) – public authorities
PV – benefits – public authorities
Benefits - society
PV - benefits - society
Total OV - benefits
Net Present Value - NPV (PV benefits – PV costs) €17,260,994 – €19,949,622
(mid-estimate: €1,455,892)
A summary of the present value (3% discount) costs and benefits of introducing labelling
for fuels is provided below.
Summary of costs and benefits (PV; 20 years; 3%) of policy measure #16 (labelling fuels)
by type
Costs
Businesses Administrations Society
Direct adjustment
costs
Direct
administrative costs
€15,728,476 –
€18,417,104 (mid-
estimate: €17,072,790)
€1,455,892
Direct regulatory
fees and charges
Indirect costs
Benefits
Description Businesses Administrations Society
Direct benefits
POLICY MEASURE #16 CHEMICALS IN VERY SMALL PACKAGING
Note: policy measure #16 includes actions on labelling exemption for chemicals sold in bulk
to consumers and in very small packaging. This chapter only addresses the labelling
exemption for very small packaging. The labelling exemption for chemicals sold in bulk to
consumers is addressed in the previous chapter.
CLP currently requires that chemicals in very small packaging should be labelled and the
environmental hazards communicated to end-users. However, the applicability of CLP to
some chemicals in very small packaging is contested by some industry actors. For example,
EWIMA is of the opinion that writing instruments (e.g. single-use pens/markers) are
considered as articles according to the definition laid down in the EU regulation REACH,
and, therefore, CLP would not apply (EWIMA, 2017). Whereas it is of the understanding
356
of the European Chemicals Agency and the Commission that writing instruments are
‘mixtures in containers’, following a discussion in the 27th
Meeting of Competent
Authorities for REACH and CLP264
, “COM replied that it is of the opinion that writing
instruments are mixtures in a container and that the container constitutes packaging
pursuant to Article 2(36) of CLP. However, the notion of packaging under CLP does not
necessarily spill over in the Waste Packaging Directive”. The Commission subsequently
followed up by stating that they would not re-open this discussion in CARACAL as long as
no new information becomes available which could change COM’s conclusion.
Policy measure #16 grants an exemption from labelling obligations under the CLP
Regulation for the inner packaging of chemicals supplied in very small packaging (below
10 ml), by extending the current exemption provided under Article 29, which currently only
applies to chemicals used for scientific R&D or quality control analysis, to all chemicals
that exhibit less severe hazards. As it is currently already the case for chemicals used for
scientific R&D or quality control analysis, the exemption would be granted subject to the
condition that the inner packaging is contained within an outer packaging that meets the
requirements of Article 17. Writing instruments and other chemicals supplied in very small
packaging that contain chemicals that exhibit more severe hazards remain covered by all
current obligations in CLP (i.e. Article 29). However, it is assumed that only a small
proportion of writing instruments contain chemicals that exhibit more severe hazards.
Economic impacts
A position paper by EWIMA (2017) provided information on the cost of conducting
business, in response to discussion held previously on the labelling of writing instruments
at CARACAL. The paper reports that manufacturers of writing instruments would have one-
off costs of between €500,000 – €7,000,000 and annual recurring costs of €4,000,000 –
€14,000,000 to comply with CLP labelling provisions.
Assuming the costs identified for writing instruments would apply to other products
containing hazardous chemicals in very small packaging that are currently unlabelled,
policy measure #16 would lead to a cost saving estimate of between €500,000 - €14,000,000
per manufacturer.
Data received from the Open Public Consultation estimated the number of products placed
on the market which contain hazardous chemicals in very small packaging to be between
735 million and 898 million, which would all not require labelling under this policy option.
Over 95% of these are writing instruments, such as pens. Therefore, a labelling exemption
will significantly reduce labelling costs.
EWIMA (2017) also reports that because of the low sale price of pens, typically around
€0.15 per pen, and the long-term practice of selling them as single items, labelling and
packaging costs would be too expensive and would mean that certain single-sold writing
instruments would have to be withdrawn from the market.
Public authority cost are the result of enforcement activities that are currently carried out
to check the compliance of chemicals sold in small packaging. For example, the REF-6
264
European Commission (2018): 27th Meeting of Competent Authorities for REACH and CLP (CARACAL)
–18 June 2018 CA/72/2018
357
enforcement project carried out 194 checks on mixtures sold in small packaging. If an
exemption was granted for these products, enforcement in this area could be reduced and
resources could be diverted to areas of higher relevance for health and the environment.
Based on the cost estimate of €879 for carrying out an on-site inspection, the REF-6 project
on mixtures in small packaging is estimated to cost approximately €170,000, which would
present the cost saved on enforcement under policy measure #16. It is not expected that a
specific enforcement project on refill chemicals would occur every year and, therefore, the
annual cost would be even lower (a factor 3 is applied providing a cost of €57,000 per year
per enforcement project).
The introduction of a labelling exemption and a clarification of the applicable rules
chemicals in very small packaging is expected to have a positive impact on the functioning
of the internal market, as labelling rules would be more harmoniously applied across all
Member States. The removal of the labelling obligation would also reduce the cost of
business and reduce barrier to trade, particular for small items such as pens sold in multiple
Member States, as it is practically not possible to apply multilingual labels to the inner
packaging of such small items due to the limited space.
The position of SME is that the costs of complying with current CLP labelling provisions
are significant, and place a very high administrative burden on any SME. Policy measure
#16 provides an exemption from labelling and would, therefore, have a significant positive
impact on SMEs.
As mentioned previously, the cost of complying with current CLP labelling provisions
would lead to an increase in the price of writing instruments and could see certain writing
instruments withdrawn from the market and no longer available to consumers. Policy
measure #16 would, therefore, have a positive impact on the price of consumer goods as
price increases would no longer be necessary. Price increases for other products containing
chemicals in small packaging (e.g. essential oils, superglues, lighters, printing inks) have
higher price points and therefore are not expected to be impacted by increased consumer
prices, and the increased production costs due to labelling can be more easily absorbed.
358
Table 107: Economic impacts
Impact
Category
Impact Positive or
negative
Direct or
indirect
Monetised
Impact
One off or
recurrent
Conduct of
Business
Labelling
Costs
(+) Direct
One-off cost
saving of
€500,000 –
€7,000,000
per
manufacturer
Annual cost
savings of
€4,000,000 –
€14,000,000
One-off &
Recurrent
Product
Withdrawal
(+) Direct
Not
quantified
Recurrent
Public
Authority
Costs
Enforcement
Costs
(+) Direct
Approx.
€57,000 cost
saving
Recurrent
Functioning
of the
Internal
Market and
Competition
Level of
Enforcement
across
Member
States
(+) Indirect
Not
quantified
Recurrent
Position of
SMEs
Operation of
SMEs
(+) Indirect
Not
quantified
Recurrent
Consumers
and
households
Price of
Consumer
Goods
(+) Indirect
Not
quantified
Recurrent
Environmental impact
Policy measure #16 would have a positive impact on resource use and packaging and
labelling waste, as the use of stickers, leaflets, blister cards, and additional packaging would
in most cases no longer be needed to meet CLP labelling provisions. Information presented
in previous sections estimated that between 734 and 898 million products containing
chemicals in very small packaging were placed on the EU market in 2019. Over 95% of
these are pens and writing instruments. Although the quantity of these products that are
currently sold as single unpackaged and unlabelled items is not known, if this was even a
small percentage of the total, a significant amount of additional packaging and labelling
material would be required for them to remain on the market without policy measure #16.
The CLP Regulation currently requires that all chemicals in very small packaging should
be labelled and the environmental hazards communicated to consumers. Policy measure #16
sets exemptions for certain chemicals meaning information on environmental hazards will
no longer be communicated in cases where environmental hazards are relevant (unless the
hazards of the chemical in question exhibits severe hazards), which might reduce the level
of protection for the environment, as end-users would have limited information on safe use
359
and disposal. This may have a slight negative impact on environmental protection is
expected. However, this impact is expected to be small in reality because these items are
already today largely sold without a label and the quantities in question are small (although
accumulated, e.g. over all writing instruments, not insignificant). Furthermore, the
exemption would not apply for chemicals with more severe hazards. On the flip-side, this
small reduction of the level of protection for the environment is probably offset by the
significant savings on resource use and waste that would be necessary when ensuring
compliance with CLP without policy measure #16. As policy measure #16 would clarify
rules on these chemicals and, therefore, a greater rate of labelling is expected for the
chemicals that remain subject to labelling because they exhibit more severe hazards. This
means better communication of information on environmental hazards, which will increase
the level of protection for the environment, as end-users will have more information on safe
use and disposal. Furthermore, producers or producers of writing instruments that contain
chemicals with more severe hazards might be encouraged to substitute those chemicals due
to market pressures. Therefore, overall, a positive impact on environmental protection is
expected.
Table 108: Environmental impacts
Impact
Category
Impact Positive or
negative
Direct or
indirect
Monetised
impacts
One off or
recurrent
Sustainable
consumptio
n and
production
Impact on
Resource
Use
(+) Direct
Not
quantified
Recurrent
Impact on
the
protection of
the
environment
(+) Indirect
Not
quantified
Recurrent
Waste
production,
generation
and
recycling
Impact on
Packaging
and
Labelling
Waste
(+) Direct
Not
quantified
Recurrent
A summary of the costs and benefits of exempting labelling of items in very small packaging
are presented below:
Summary of cost and benefits of policy measure #16 (labelling of very small packaging)
Costs - businesses
Total one-off costs over a 20-year period
Recurring costs every 1 year
Total recurring costs over a 20-year period
PV of one-off costs (20 years; 3%)
PV of recurring costs (20 years; 3%)
Total PV – costs - businesses
Costs – public authorities
Total one-off costs over a 20-year period
360
Recurring costs every 1 year
Total recurring costs over a 20-year period
PV of one-off costs (20 years; 3%)
PV of recurring costs (20 years; 3%)
PV of recurring costs (20 years; 3%) (annualized)
Total PV – costs – public authorities
Total PV cost of policy measure #16 (labelling of very small
packaging)
Benefits (cost savings) - businesses €76,500,000 – €273,000,000
(mid-estimate:
€174,750,000)
PV benefits - businesses €102,840,033 –
€366,997,763 (mid-estimate:
€234,918,898)
PV benefits – businesses (annualized) €5,142,002 – €18,349,888
(mid-estimate: €11,745,945)
Benefits (cost savings) – public authorities €1,083,000
PV – benefits – public authorities €1,455,892
Benefits - society
PV - benefits - society
Total OV - benefits
Net Present Value - NPV (PV benefits – PV costs) €104,295,925 –
€368,453,656 (mid-estimate:
€236,374,790)
A summary of the present value (3% discount) costs and benefits of exempting labelling of
items in very small packaging are presented below:
Summary of costs and benefits (PV; 20 years; 3%) of policy measure #16 (labelling fuels)
by type
Costs
Businesses Administrations Society
Direct adjustment
costs
Direct
administrative costs
Direct regulatory
fees and charges
Indirect costs
Benefits
Description Businesses Administrations Society
Direct benefits
361
Direct
administrative cost
savings
€102,840,033 –
€366,997,763 (mid-
estimate: €234,918,898
€1,455,892
STAKEHOLDERS VIEWS ON POLICY OPTION 2
With regard the policy options 2 related to hazard communication, the respondents to the
open public consultation generally welcomed the consideration to allow a broader use of
multilingual fold-out labels and introduce tailored labelling rules where there is insufficient
space on the packaging. The open public consultation, targeted stakeholder surveys and
interview respondents emphasised the importance of proper arrangement of content on
labels – effectively using small packaging space by prioritising visual information, reducing
the volume of information on the label, etc.
Furthermore, targeted stakeholder surveys and interview respondents emphasised the
importance of proper CLP labelling of refill chemicals to ensure that customers get all safety
information. Similar concerns were raised in the discussion during CARACAL meeting and
in the written feedback.
STAKEHOLDERS VIEWS ON SPECIFIC PRODUCTS: CLP LABELLING OF
AMMUNITION
Under the public consultation, the defence industry sector provided a position paper related
to CLP labelling of ammunition and requested to:
 Have a general exemption to place UFI code(s) on ammunition since there would be
no added value in terms of providing emergency health response;
 Adjust the labelling requirements for ammunition in order not to label the immediate
packaging layer containing it, but the outer one, to ensure good functioning and
security;
 Provide for a CLP labelling exemption in deployment scenarios of camouflage
needs;
 Better regulate the SDS requirements applying to articles by proposing a specific
format.
The Commission did not assess the specific impacts of this request since it wanted to keep
policy options at a general basis – and not sector limited – as well as due to time constraints.
Moreover, the Commission understands that this request is very sector specific and does not
have impacts on the overall CLP labelling system.
MONITORING
For some specific objectives of the revision of the CLP Regulation, a number of additional
streams will also be important:
362
EU barometer surveys: these surveys provide very useful information on how well informed
citizens/consumers feel about the dangers and safety of chemicals and on their level of
understanding of labelling. As the last EU barometer survey found that about 55% of the
interviewers felt not well informed, it is proposed that after 5 years from the entry into force
of the new measures a new survey includes corresponding questions to assess progress.
EU enforcement projects: the level of compliance with CLP rules is regularly monitored by
the Forum for Exchange of Information on Enforcement (the Forum), a network of
authorities responsible for the enforcement of the REACH, CLP, PIC, POP and Biocidal
Product regulations. The Forum has been driving in the past years a number of EU wide
enforcement studies (led by the European Chemical Agency), which have been instrumental
to identify the level of non-compliance with the CLP Regulation across Member States.
Those studies were also widely used for the evidence collected for this impact assessment,
in particular to identify the communication gaps on labelling and the implementation gaps
for online sales and imported articles. As the Chemicals Strategy for Sustainability also
prioritises those areas for further action by Member States and the Forum, monitoring
progress on those areas through targeted Forum’s activities should take place. Those data
will also feed the overall enforcement and compliance indicators that are currently under
development as part of the future framework of indicators on chemicals.
PRACTICAL IMPLICATIONS OF THE OPTION OR SUB-OPTION
Summary of costs and benefits
Table 109: Comparison of measures for hazard communication.
Options Effectiveness
Key impacts Benefit/cost
ratio
Efficiency Coherance
Economic Social Environmental
PO2a
Update/prepare
guidance
Limited
extension of
clarifications
Minimal
positive
Minimal
positive
Minimal
positive
Very limited
benefits with very
limited costs
Low Not relevant
PO2b
Improving and
making more
flexible existing
labels
High – in
tackling absence
of labels and
improved hazard
communication
Negative costs
for business
€0.34-0.6
million
Negative
impacts for font
size
(undetermined)
Highly
positive
(increased
safety
information
available to
users)
Slightly
positive (more
information
available to
users)
Positive High Not relevant
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Annex 13 – Digital labelling
INTRODUCTION & CONTEXT
On top of the detailed section on labelling (Annex 12), this Annex focusses specifically on
a new area of amendment to the CLP Regulation, which looks at possibilities of providing
certain labelling elements digitally. As this area of labelling intervention was supported by
a comprehensive and separate Impact Assessment supporting study, it is presented in a
stand-alone Annex.
Context
During the course of 2019, the European Commission published the Fitness Check of the
most relevant chemicals legislation265
(excluding REACH, hereafter ‘the Fitness Check’).
This evaluation provides a comprehensive assessment regarding the performance of the EU
chemicals legislation in light of its objectives of protecting human health and the
environment, ensuring the efficient functioning of the single market and enhancing
competitiveness and innovation. While concluding that legislation is overall fit for purpose,
it also pointed to several issues with current labelling requirements and hazard
communication measures. Certain findings (among others) showed that:
1. there is room for simplification in the communication of hazard and safety
information to consumers and for improvement in terms of its effectiveness and
efficiency; and
2. the use of innovative digital tools for the communication of such information is
currently suboptimal.
3. there are some regulatory overlaps, which lead to confusing and overloaded labels.
Digital labelling under the CLP Regulation was investigated in the broader context of the
European Green Deal266
, the European Union’s strategy to set up a sustainable climate
neutral and circular economy by 2050 and the EU industrial strategy267
for a competitive,
green and digital Europe which published on 10 March 2020 to address the twin challenge
of the green and the digital transformation. Further, this initiative aims to contribute to the
high level European Commission priority (2019-2024) of a ‘Europe fit for the digital age’,
as the Commission is determined to make this Europe's “Digital Decade”. As a priority,
265
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE
EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS
Findings of the Fitness Check of the most relevant chemicals legislation (excluding REACH) and identified
challenges, gaps and weaknesses (COM/2019/264 final): https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1561530857605&uri=COM:2019:264:FIN
266
European Commission, 2019, The European Green Deal. Available at: https://eur-
lex.europa.eu/resource.html?uri=cellar:b828d165-1c22-11ea-8c1f-
01aa75ed71a1.0002.02/DOC_1&format=PDF.
267
European Commission, 2020, A New Industrial Strategy for Europe. Available at: https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020DC0102
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Europe is strengthening its digital sovereignty and setting standards with a focus on data,
technology, and infrastructure.
Further, in the context of the European Green Deal, the European Union’s strategy to set up
a sustainable climate neutral and circular economy by 2050, the EU industrial strategy for
a competitive, green and digital Europe was published on 10 March 2020 to address the
twin challenge of the green and the digital transformation. Also in the context of the
European Green Deal, the Chemicals Strategy on Sustainability was published on 14
October 2020 and it sets objectives to ensure a better protection of human health and the
environment from hazardous chemicals, as well as to boost innovation for safe and
sustainable chemicals, and to enable a transition to chemicals that are safe and sustainable
by design. In order to further achieve the goals of the European Green Deal, the Circular
Economy package and the proposal for a Regulation on Eco-design for Sustainable Products
was adopted on 30 March 2022268
. The proposal establishes a Digital Product Passport
(DPP) which will hold information on all regulated products and their value chains. The
objective of the DPP is to support sustainable production, to enable the transition to circular
economy, to provide new business opportunities to economic actors, to support consumers
in making sustainable choices and to allow authorities to verify compliance with legal
obligations. This initiative is particularly relevant for digital labelling under CLP, because
it foresees the mandatory adoption of digital ways of communicating information about
products, including those covered by CLP.
The safe and sustainable use of chemicals within the Sustainable Development Goals
Improving the regulatory framework of chemicals to better protect human health and the
environment is also in line with larger economic, societal and environmental challenges and
objectives, such as the United Nations’ 2030 Agenda for Sustainable Development which
defines the Sustainable Development Goals (SDGs).
Firstly, protecting consumer health as set out in the European Union’s Chemical Strategy
for Sustainability, contributes to the SDG 3 which aims to ensure healthy lives and promotes
well-being for all, at all ages. More specifically, target 3.9 sets a goal to substantially reduce
the number of deaths and illnesses from hazardous chemicals and air, water, and soil
pollution and contamination by 2030. Digitalisation offers opportunities to reach more and
in particular vulnerable consumer better. Digital labels would facilitate the integration of
labelling information in digital tools that assist e.g. elderly or disabled consumers.
Digitalisation also offers opportunities to provide more language versions of labels, in
addition to those that are obligatory on the physical label.
Secondly, the objectives of the Chemical Strategy for sustainability is to better protect the
environment also relate to SDG 6 which aims to ensure the availability and sustainable
management of water and sanitation for all, and more specifically to target 6.3, to improve
water quality by, among other things, eliminating dumping and minimizing the release of
hazardous chemicals and materials by 2030.
Finally, the regulatory framework for chemicals should also contribute to the fulfilment of
SDG 12, to ensure sustainable consumption and production patterns, and more specifically,
268
European Commission, 2022, Communication on making sustainable products the norm. Available at:
https://ec.europa.eu/environment/publications/communication-making-sustainable-products-norm_en
365
to target 12.4 which aims for environmentally sound management of chemicals throughout
their cycle and to reduce their release into air, water, and soil in order to minimize adverse
impacts on human health and the environment.
The importance of chemicals and waste management to achieve the SDGs is also aligned
with the overall objective of the Strategic Approach to International Chemicals
Management (SAICM).269
Supported by the United Nations Environment Programme, the
SAICM is an international policy framework to promote chemical safety around the world,
and support the sound management of chemicals throughout their life cycle to minimise
their adverse impacts on the environment and human health.
Legal basis:
Article 114 of the Treaty on the Functioning of the European Union (TFEU)270
confers upon
the EU institutions the competence to lay down appropriate provisions which have as their
object the establishment and functioning of the internal market.
Regarding consumer protection, Article 169 TFEU provides that, to promote the interests
of consumers and ensure a high level of consumer protection, the Union shall contribute to
protecting the health, safety and economic interests of consumers, as well as to promoting
their right to information, education and to organise themselves in order to safeguard their
interests, and that these objectives can be reached through measures adopted pursuant to
Article 114 in the context of the completion of the internal market.
Therefore, according to Article 114 TFEU introducing any digital labelling under the CLP
regulation is subject to the shared competence of the EU. In this situation, Article 5 TEU
and the principle of subsidiarity271
provide that the Union shall act only if, and in so far as,
the objectives can be better achieved at Union level than by Member States. Since the
objectives of the regulations concerned in this study necessitate common provisions
throughout the EU, Article 114 TFEU can serve as the appropriate legal basis for this
initiative.272
Subsidiarity: Necessity of EU Action
The simplification of labelling requirements for chemicals and the use of digital labelling
aim at improving consumer understanding and awareness of chemical labels, by making
optimal use of digital tools to communicate product information. The overarching objectives
are to ensure that all consumers in the EU enjoy a high level of protection when using
chemical products while taking into account the current digitalisation trend.
270
Treaty on the Functioning of the European Union. Available at: https://eur-
lex.europa.eu/resource.html?uri=cellar:2bf140bf-a3f8-4ab2-b506-
fd71826e6da6.0023.02/DOC_2&format=PDF.
271
Treaty on European Union. Available at: https://eur-lex.europa.eu/resource.html?uri=cellar:2bf140bf-a3f8-
4ab2-b506-fd71826e6da6.0023.02/DOC_1&format=PDF.
272
Recital 2 of the CLP Regulation provides that “the efficient functioning of the internal market for
substances, mixtures and those articles can be achieved only if the requirements applicable to them do not
differ significantly between Member States”. This reasoning can also be find in Recital 2 of the Detergents
Regulation.
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Currently, there is room for improvement in terms of the understanding and awareness of
chemical labels across the EU. Especially as the classification, labelling and packaging of
substances and mixtures under the CLP Regulation is harmonised at Union level, it is
appropriate that the digital labelling under the same regulation continue to be regulated at
EU level to achieve their objectives, i.e. to increase the protection of consumers while
ensuring the free movement of chemicals in the internal market.
At the same time, national action and/or absence of EU level action could create inequalities
and asymmetries between the protection of consumers in different Member States. It could
also increase costs for industry to adapt to different labelling requirements in different
Member States and hinder the good functioning of the internal market for chemical
products. Differing approaches would also make it more difficult for consumer to obtain the
relevant information.
EU action is also needed because of the strong cross-border dimension of the problem: as
explained above, Europe is the second largest chemicals producer in the world and
chemicals products supply almost all sectors of the economy. It is estimated that around 543
€ billion worth of chemicals are produced annually and move freely within the EU thanks
in part to the CLP Regulation, and to sector-specific regulations such as the Detergents
Regulation. The magnitude and cross-border nature of the sector indicate that action in this
sector should be taken at EU level.
Subsidiarity: Added value of EU action
The added value of EU action is to improve the current legislative framework at the EU
level to address the problems identified in this Annex, while also taking into account the
current market developments of the sector.
Specifically, the digital readiness of the EU regulatory framework surrounding chemical
products cannot be efficiently tackled at national level and needs to be harmonised in order
for industry to reap the benefits of digitalisation in the communication of product
information. Also EU action will ensure that consumers have the same access to information
wherever they purchase or use chemical products in the EU. The use of digital tools is not
limited to a single Member State, and rules fit for the digital age are needed across all of
Europe to foster cross-border activity and competition. Digital improvements to the current
legislation, such as including the possibility for some labelling requirements to be provided
digitally, could improve the functioning of the internal market and the protection of
consumers if they are undertaken at EU level.
Finally, the added value of EU action also lies in the existence of economies of scale in the
chemical industry. The harmonisation of labelling requirements across the EU allows
manufacturers to use multi-lingual labels and to distribute the same products (with the same
label) in more than one Member State.
PROBLEMS AND DRIVERS
As demonstrated by the Fitness Check, even if chemicals legislation is overall fit for
purpose, there are still several issues with current labelling requirements, reducing the
effective communication of hazard and safety information.
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The link between problems identified their drivers and consequences is visualised in the
problem tree below:
Figure 80: Problem tree
Findings of the Fitness Check
The Findings of the Fitness Check showed that chemical legislation is overall fit for purpose,
but proposed several suggestions for improvement, including in the communication of
hazard and safety information. Based on the Special Eurobarometer survey273
number 456
the Fitness Check reports that “a low level of understanding of certain pictograms, labels,
and precautionary statements partially due to the overload of information”274
.
The level of understanding is influenced by the amount of information on chemical labels.
This is affected by having too much text or technical language that consumers are not
familiar with, text in multiple languages, as well as repeating text caused by overlaps in
legal requirements (e.g. between, CLP and Detergents Regulation and/or the Cosmetic
Products Regulation). The Fitness Check also pointed out that the current approach to the
labelling of allergens could be improved so that consumers are better protected and informed
in case of allergies. The Fitness Check further identified the opportunity to improve the
communication of product information by including the use of technologies such as QR
codes. Potential burden reduction for SMEs, were also presented as potential benefits of
273
Special Eurobarometer 456, 2017. Available at: https://europa.eu/eurobarometer/surveys/detail/2111.
274
Findings of the Fitness Check of the most relevant chemicals legislation (excluding
REACH) and identified challenges, gaps and weaknesses, p.9. Available at: https://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:52019DC0264&from=EN
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increased use of digital technologies. Potential burden reduction for SMEs, as well as an
improvement of enforcement and compliance by the relevant competent authorities (e.g.
Market Surveillance Authorities, customs) were also presented as potential benefits of such
improvements.
Problem drivers
Three key problem drivers to the current labelling requirements of CLP, in the context of
digital labelling have been identified:
1. Market development:
Since the entry into force of the CLP regulation, digitalisation has led to the development
of new labelling technologies which are not adequately captured by the current scope of the
regulatory framework. Currently no mention is made in the regulation of the possibility to
use e-labelling solutions to communicate product information to users. This is despite the
increasing use in Europe of mobile devices and internet.275
The digital readiness of the
regulatory framework surrounding chemical products needs to be addressed in order for
industry and consumers to reap the benefits of digitalisation in the communication of
product information.
2. Sub-optimal framing of information on labels, discouraging consumers from reading
and using it:
A second driver identified in this study is the sub-optimal framing of the information on
chemical labels discouraging consumers from looking at the information and using it.
In particular, two characteristics have been identified: the complexity of information
provided for the average consumers, and the use of multi-lingual labels leading to the need
for small font size.
Some of the information provided on chemical labels contains technical and scientific
terminology, not used in the day-to-day lives of consumers. This creates a lack of
understanding of the link between this chemical terminology and their meaning in the
context of the label (i.e. their properties in the product). In particular, the use of chemical
names can sometimes be seen as an obstacle for consumer understanding of chemical labels.
At the same time, the behavioural experiment conducted for this study shows that, overall,
consumers are able to interpret the Status Quo Label correctly (i.e. regarding hazards) and
that CLP-relevant information items are rated as both easy to understand as well as easy to
find. These results can also be explained by the fact that in the experiment, consumers were
incentivised to read the label, thus increasing their understanding in comparison to day-to-
day situations. This suggests that one attention is paid to finding the relevant labelling
elements and reading them carefully, overall they are effective. Digitalisation could help
with that by moving less critical information from the physical label to the digital label, so
that information can better be found.
Secondly, the Fitness Check pointed out that consumers and workers do not understand
some of the CLP pictograms (in particular GHS04 – gas cylinder and GHS07 – exclamation
275
Eurostat, Digital Society statistics at regional level. https://ec.europa.eu/eurostat/statistics-
explained/index.php?title=Digital_society_statistics_at_regional_level#Internet_users
369
mark pictograms). Similarly, in the Special Eurobarometer participants were least familiar
with the serious health hazard symbol – 20% reported having seen the symbol before – and
only 17% understood the exclamation mark symbol. This was confirmed by some
stakeholders during the interviews for this study. At the same time, it should be noted that
the purpose of pictograms is to catch attention and complement the text on the label. They
also work, to a certain degree, on their own, for people that are illiterate, so that they realise
that they may have to seek more information. Therefore, it is not necessary that the
pictogram is fully understood. Additionally, for professional users who should be more
knowledgeable about pictograms, they can provide a quicker means of communication
compared to reading the text.
Furthermore, under the CLP Regulation, the legal requirements specify that information on
labels should be available in the official language(s) of the country in which the product is
distributed. While this makes multilingual labels mandatory only in countries with more
than one official language, such labels are a common practice in the industry across all EU
countries.
Multilingual labels are used to achieve economies of scale, by allowing the industry to
distribute one product with the same label across several countries. This is especially useful
in smaller countries (e.g. in the Baltic countries). Thus, multilingual labels save money and
material, they allow for flexibility in planning, and they reduce waste. In addition, it was
highlighted that separate production for each market might be so complex that companies
could decide to abandon smaller markets. However, the use of several languages to comply
with labelling requirements also takes more space on labels and leads to a smaller font size
to be used to communicate information, and makes information more difficult to find.
3. Regulation overlaps, duplications and inconsistencies
The third driver concerns legal overlaps, duplications, and inconsistencies between the
CLP and Detergents regulations276
. These issues are due to the fact that the Detergents
Regulation was designed before GHS was developed by the United Nations, and therefore,
before the CLP Regulation entered into force. These overlaps are explained below to
extensively illustrate the problem of understanding chemicals labels, however, it should be
noted that such overlaps will be addressed in the sectorial legislation (i.e. in this case in the
Detergents Regulation277
) and not in the horizontal regulation (CLP).
This driver can be divided into 3 issues:
First of all, under the CLP, ingredient substances that present certain hazards must be
included on the product label using a chemical name (e.g., MEA-dodecylbenzene
sulfonate), whereas under the Detergents Regulation ingredients can be listed under a
generic name (e.g., anionic surfactant). Complying with the labelling requirements of both
Regulations results in the listing of the same ingredient twice, and in some cases using
different names.
276
A full legal analysis was conducted during this study and is available in Annex 13c.
277
Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on
detergents. Available at: https://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32004R0648&from=EN.
370
Secondly, the Detergents Evaluation revealed some legislative overlaps between the
Detergents Regulation and the CLP with regard to the labelling of allergenic fragrances.
Other overlaps also exist e.g., on the labelling of surfactants278
and allergenic preservatives
when CLP thresholds are met.
Thirdly, the Detergents Regulation requires the label to include the allergenic fragrances
listed in Annex III to the CPR and which are added to detergents at concentrations exceeding
0.01% by weight. The labelling of these fragrances shall be done using the International
Nomenclature of Cosmetic Ingredients ("INCI names"). In parallel, the CLP requires the
inclusion of skin sensitisers279
(i.e., allergenic substances like preservatives and fragrances)
in the list of ingredients that need to figure on the product label when they are present above
certain thresholds.1
These thresholds are different from the thresholds provided in the
Detergents Regulation. As most allergenic fragrance ingredients under the Cosmetic
Products Regulation are also classified as skin sensitisers under the CLP, this may lead to
the labelling of the same substance twice, once following the Detergents Regulation and
once following the CLP.
The three drivers above lead to three overarching problems:
The potential of electronic labels is not fully exploited in the market of chemical products
and detergents.
There is a certain lack of awareness and understanding of chemical labels in the EU,
which can be an issue for consumer health.
Chemical labels can become overloaded with information and they could be streamlined
and simplified to facilitate their understanding and reduce the administrative burden for
industry related to labelling requirements.
Each of these problems are described below.
Problem definition
Problem 1: The potential of electronic labels is not fully exploited in the market of chemical
products and detergents.
Due to the lack of regulations or incentives in the chemical legislative framework to use
digital tools, the use of electronic labels is currently inferior to is potential use in the market
of chemical products and detergents.
Indeed, besides the obligation for manufacturers to provide a full ingredient list on a website
under the detergents regulation, the CLP and the Detergents regulations do not include the
possibility to use digital labelling solutions to communicate product information to users.
Therefore, the current use of digital labelling for chemical products, including detergents,
is only limited to ad hoc voluntary initiatives by manufacturers, and it remains
unharmonised across Europe.
278
A full legal analysis was conducted during this study and is available in Annex 13c.
279
Special Eurobarometer 456, 2017. Available at: https://europa.eu/eurobarometer/surveys/detail/2111.
371
Problem 2: Difficulty for consumers to understand the hazard and safety communication on
chemical labels
One of the problems that needs to be tackled is the current low understanding of chemical
labels among consumers in Europe, with significant variation across user groups and
Member States.
In Special Eurobarometer 456, less than half of respondents (45%) felt informed about the
potential dangers of chemicals in consumer products. In consultations carried out for this
study, all stakeholder groups (except public authorities) indicated that the clarity and
understanding of chemical labels could be improved. Similarly, during interviews, a
majority of stakeholders from both the business sectors and consumer associations stated
that chemical labels as they are now are not well understood by consumers, for a variety of
reasons.
Furthermore, consumer understanding of chemical labels is very heterogeneous across
Europe. Indeed, in the Special Eurobarometer survey, Northern Europeans reported feeling
more informed compared with Southern Europeans. This heterogeneity was also highlighted
during the interviews where, for example, two stakeholders from both the business and
consumer sectors highlighted the fact that in Denmark there is a high awareness and
understanding of chemical labels among consumers. This can be explained by a highly-
educated population, consumer associations and national authorities that actively inform
consumers, and a high-level of digital literacy with consumers willing to look for further
information online.
Finally, understanding of chemical labels also varies between consumers and professional
users and industrial workers. All categories of stakeholders pointed out that there is a clear
difference in understanding of hazard and safety instructions communicated on chemical
labels between these different user groups. This difference is explained by the fact that
professional and industrial workers are trained to understand the information on the label
and that they have access to additional tools (e.g. the Safety Data Sheet). Moreover, around
two-thirds of companies also provide additional training on chemical products or
substances, e.g. on hazards or precautions of safely using these products. A combination of
these measures explains the higher level of understanding of chemical labels among
professional users and industrial workers compared to the consumers.
Problem 3: Labels overloaded with information
Sub-problem 1: Overlapping and duplicated ingredients
The current labelling requirements in the CLP Regulation can lead, in some cases, to an
overlap or a redundancy of information between ingredients. Under CLP, ingredients
that present a chemical hazard should be included on the product label using the chemical
name (e.g., MEA-dodecylbenzene sulfonate), whereas under the Detergents Regulation
ingredients can be listed under a generic name (e.g., anionic surfactant). Complying with
the labelling requirements of both Regulations results in the labelling of the same ingredient
twice, and in some cases using different names.
The Detergents Regulation requires the label to include the allergenic fragrances listed in
Annex III to the CPR and which are added to detergents at concentrations exceeding 0.01%
372
by weight on detergents’ labels. The labelling of these fragrances shall be done by using the
International Nomenclature of Cosmetic Ingredients ("INCI names").
In parallel, the CLP requires the inclusion of skin sensitisers (i.e., allergenic substances like
preservatives and fragrances) in the list of ingredients that need to figure on the product
label when they are present above certain thresholds. These thresholds are different from
the thresholds provided in the Detergents Regulation, the latter being lower than the former.
As most allergenic fragrance ingredients under the Cosmetic Products Regulation are also
classified as skin sensitisers under the CLP this may lead to the labelling of the same
substance twice, once with its INCI name following the Detergents Regulation and once
following the CLP with its chemical name.
Addressing this redundancy could increase the efficiency of hazard and safety
communication on chemical labels and improve their understanding, and reduce
administrative burden.
A full analysis of the legal overlaps, inconsistencies and duplications can be found in Annex
10c.
Sub-problem 2: A lot of information communicated through written texts
In addition to legal inconsistencies, the sub-optimal framing of information as described in
driver 2 also contributes to overloaded labels because a lot of information is communicated
through written text which takes a lot of space on labels.
Information overload makes it difficult for users to focus on the most relevant information
on the label. In particular, the long hazard (H) and precautionary (P) statements on multi-
lingual labels can result in a significant amount of information that can become difficult to
read and understand. In addition, the overload of labels lead to texts being written in very
small print/font size which hampers readability. While multi-lingual labels foster the single
market and they can be beneficial economically for businesses, the overloaded label clashes
with consumer protection by hindering labels’ readability.
Furthermore, while a lot of information are written on the labels, it can be argued that
consumers spend little time reading the information provided on chemical labels. According
to a study commissioned by A.I.S.E, consumers spend 22 seconds on average to read
chemical labels, irrespective of the content.280
Interviews conducted for this study
confirmed that consumers usually spend only a few seconds reading labels, except in case
of accidents. In comparison, the behavioural experiment for this study showed that, on
average, 62 seconds for laundry detergent and 78 seconds for the glue were required for
consumers to answer a set of questions about the content of the label. For both products,
there was a positive and significant relationship between the time spent reading the label
and the chances of a correct answer to questions on product hazards. In summary, without
an incentive to do so, consumers do not spend sufficient time reading the current chemical
labels to understand them. This can lead to gaps in consumer protection, especially in
280
Maggie Geuens, Dominic Byrne, Geert Boeije, Virginie Peeters and Bert Vandecasteele, 2021,
“Investigating the effectiveness of simplified labels for safe use communication: The case of household
detergents”. International Journal of Consumer Studies, DOI: 10.1111/ijcs.12662.
373
conjunction with some labelling requirements, such as long written statements, that are
difficult to understand quickly.
Magnitude and EU dimension of the problem
The magnitude of the problems described above can be first assessed by looking at the size
of the chemicals sector in Europe, and therefore at the size of the market of impacted
products. Europe is the second largest chemicals producer in the world with 499 billion
euros (7,5% of EU manufacturing by turnover ) and 14,4% of global sales. In terms of
allocation across Europe, two thirds of these sales are made in four Member States:
Germany (32,1%), France (13,5%), Italy (10,7%) and the Netherlands (8,9%). In addition,
the sector is responsible for the direct employment of about 1,2 million people in Europe
and it supplies almost all sectors of the economy (textiles, construction, agriculture,
transport, health, hygiene, housing, food…) because 56% of EU chemicals are sold as an
input to other industrial sectors.
The important place of the chemical sector in the European economy and the use of
multilingual labels to allow for economies of scale and to foster the internal market in
Europe contribute to the EU dimension of the problems described above. More information
on the size of the market of chemical products in EU is provided under the description of
the baseline in Chapter 5.
The extent to which European consumers are impacted by the above mentioned problems
also needs to be considered. According to the Special Eurobarometer 456, less than half of
respondents (45%) felt informed about the potential dangers of chemicals in consumer
products. Similarly, the behavioural experiment shows that for the current label, the
objective understanding of product hazards, precautionary measures and ingredients were
rather poor.
Finally, since only voluntary industry initiatives exist at EU level to use digital labels, there
are only ad hoc practices by manufacturers, and therefore a very limited and inconsistent
use of such labels across all EU Member States.
Stakeholders affected by the problem
The (sub)problems identified lead to a variety of consequences:
Consumers: the apparent lack of understanding of the information on chemical labels is a
significant issue as these are the primary tool for communicating the hazards associated with
the use of certain products. Misunderstanding of their meaning may lead to the inappropriate
use of products, potentially resulting in negative impacts to human health and/or the
environment. Indeed, the main sources of information for consumers on the potential
dangers of chemicals are product labels (used by 70%) and the media (53%).281
A lack of
understanding of chemical labels by consumers, leads to a lack of awareness about the
dangers of chemicals, with a potential detriment for their health and safety.
Environment: in addition to the impacts on consumers’ health, the inappropriate use of
products can have negative effects on the environment, especially if the rules on dosage or
281
Special Eurobarometer 456, 2017. Available at: https://europa.eu/eurobarometer/surveys/detail/2111.
374
disposal of the product, as communicated on the label, are not respected. Understanding of
chemical labels is therefore of primordial importance to ensure a sustainable use of chemical
products in the environment.
Industry: a cumulative costs assessment study found that certain chemical industries, in this
case the detergents industry, faces a relatively high administrative burden to comply with
EU legislation compared with other sub-sectors within the EU chemicals industry.282
Further, an evaluation of the detergents regulation283
found that labelling requirements are
an important part of such administrative burdens and concluded that, in light of the above
challenges, there may be a need to consider more innovative communication approaches to
reduce information overload and to enable consumers to access additional information on
the properties of products and on their safe use. In particular, the use of digital tools was put
forward as a possible solution.
How will the problem evolve?
Without any interventions, the problems described above will continue to exist, and to have
social, economic, and environmental consequences.
The foreseen revisions of CLP and the Detergents Regulation could have a positive impact
and contribute to diminishing the problems related to the understanding of hazard and safety
information by consumers and labels overloaded with information in the future. However,
without any interventions to regulate and promote digital labelling, its use will remain
inferior to its potential, with dispersed ad hoc practices by manufacturers across Europe.
The description of how the problems will evolve in the future without intervention is further
expanded in the Chapter 5, in the description of policy option 0.
The ongoing developments in the context of the Digital Product Passport and the
development of a GHS framework for digitalisation means that eventually there would the
risk of future inconsistencies or shortcomings in EU legislation.
OBJECTIVES
The general objective of the digitalisation of labelling requirements under the CLP
regulation is to ensure and improve consumer safety, in light of the digitalisation trend.
In other words, the policy options developed under this initiative must ensure a higher or at
least the same level of safety for consumers using chemical products, while allowing
industry and society to reap the benefits of digitalisation for chemical labels.
This general objective is in line with the objectives of the CLP Regulation, to ensure a high
level of protection of human health and environment as well as the free movement of
282
European Commission, 2016, Cumulative cost assessment for the EU Chemical Industry. Final Report.
https://ec.europa.eu/docsroom/documents/17784/attachments/1/translations/en/renditions/pdf. See also
A.I.S.E Factsheet, Findings for the detergents and maintenance products industry.
https://www.aise.eu/documents/document/20161024164027-
cumulative_cost_assessment_aise_factsheet_oct_2016_final.pdf
283
Commission Staff Working Document, Evaluation of Regulation (EC) No 648/2004 of the European
Parliament and of the Council of 31 March 2004 on detergents:
https://ec.europa.eu/docsroom/documents/36289
375
chemical substances, mixtures and certain specific articles, while enhancing
competitiveness and innovation.284
This general objective is also aligned with the general Treaty-based objective of good
functioning of the internal market and protection of consumers as enshrined in the TFEU
and with the Commission’s long-term objective to make Europe fit for the digital age,
allowing citizens and businesses in Europe to seize the potential of digitalisation.285
More specifically, the objective of this annex is to explore the possibilities of setting up a
future proof regulatory framework allowing the use of digital tools, and to improve
consumer understanding and awareness through improved communication of product
information.
The public consultation on the revision of the CLP Regulation found that respondents across
all stakeholder groups believe the inclusion of digital labels such as QR codes to be useful,
and agreed that there would be cost savings from providing some mandatory information
digitally rather than physically on the packaging. In particular, respondents providing
position papers across all stakeholder groups (except for ‘EU and Non-EU citizens’)
supported digitalisation of labels to improve communication of relevant product
information, even though it was highlighted that care must be taken as not all users may
have access to digital information.
Furthermore, concerning chemical labelling in general, the public consultation on the
revision of the CLP Regulation found that, when given the option to provide less but clearer
information on labels or ‘as much information as possible’, most respondents (80%)
indicated that they would prefer less but clearer information. In addition, companies and
business associations in particular (but also some citizens, public authorities and civil
society organisations) expressed concern that hazard and precautionary statements need to
be simplified.
BASELINE
Establishing a baseline
The baseline scenario allows for a comparison of the expected effects of the identified policy
options against environmental, economic and social trends, as well as legal and political
developments, including on global level. In particular, the implementation, in the European
Union, of the latest GHS revision and the activities stemming from the Strategic Approach
to International Chemical Management, in particular related to waste management.
For the forecast analysis, a 20-year period for the projections has been considered.
The following chapters describe the current situation concerning the critical developments
in the EU population, technological uptake of consumers and enterprises and the size of the
chemical industry in the EU.
284
Recital 1 of the CLP Regulation.
285
European Commission, A Europe fit for the digital age. https://ec.europa.eu/info/strategy/priorities-2019-
2024/europe-fit-digital-age_en
376
Population
Developments in the EU population described in the paragraph below are highly important
to this study considering the prospects of using digital labels in the future by vulnerable
consumers. Analysis of using digital labels needs to be performed in terms of considering
the impact of digital labels to the consumers with visual, hearing and mobility impairments
as well as older consumers, or consumer with limited to no access to the internet.
Concerning vulnerable consumers, the population of the European Union is ageing rapidly.
According to Eurostat data, physical and sensory functional limitations increase by age
group: on an average 26.8% of population experience a form of limitation (e.g. seeing,
hearing or walking). This share increases to 37.1% for the age group above 75 years old286
.
As an example, at current projections, assuming a constant share of over 75 years olds with
physical and sensory functional limitations, the number of EU citizens affected would
increase from 16.2 million in 2020, to 20 million in 2030 and 25 million in 2040. This trend
is in line with one of the “megatrends” identified Commission’s Megatrends Hub namely
“Increasing demographic imbalances”287
According to Eurostat projections, the overall population in the EU27 is expected to slightly
decrease in the 20-year period taken into account, from around 447,7 million (2020) to 446,7
(2040). However, more significant changes are expected in terms of age composition. In
particular, the share of the population above 65 years old, which in 2020 accounts for 21%
of the overall population, is expected to increase to 28% in 2040. In particular, the
population above 75 years old, which today accounts for 45 million citizens, should increase
by 11 million by 2040.
Figure 71: Physical and sensory functional limitations by sex, age and educational attainment level
Source: Eurostat ([hlth_ehis_pl1e]), VVA elaboration
Technological uptake of consumers
Technological uptake is relevant for the analysis of a regulatory intervention that would
entail the use of electronic labels on chemical products. For this analysis we have considered
statistics on the use of the internet in the last 3 months. The trends that are described in more
286
Most recent Eurostat data available for the year 2014.
287
See: Increasing demographic imbalances | Knowledge for policy (europa.eu)
0,0
10,0
20,0
30,0
40,0
Seeing Hearing Walking
Total From 45 to 54 years From 55 to 64 years
From 65 to 74 years 75 years or over
377
detail in the paragraphs below correspond to one of the megatrends in the Commission’s
Megatrends Hub namely “Accelerating technological change and hyperconnectivity”.
According to the latest Eurostat data288
, the percentage of individuals increased
considerably in the last 10 years, going from 72% of the EU27 population in 2012 to 89%
in 2021. This technology update has seen a strong increase also amongst older groups of
citizens. The percentage of individuals in the age group between 55 and 64 years old
increased by 34% between 2012 and 2021 and doubled the percentage of individuals in the
age group between 65 and 74 years old (from 28% in 2011 to 61% in 2021). According to
this trend, it is expected that in the next 10 to 20 years nearly the whole EU27 population
will use the internet regularly. Further, digital inclusion is an EU-wide effort to ensure that
everybody can contribute to and benefit from the digital world. The EU is fostering digital
inclusion through several policy areas, including digital skills and social inclusion. The use
of electronic labels could be of particular relevance for online purchases. According to most
recent data on e-commerce , the share of European population that reported having made
an online purchase in the previous 12 months, in 2021 was 66%. A share that decreases
from an average of 81% for the age groups between 16 and 34 years old, to 54% for the
age group 55-64 and around 35% for the age group 65-74. According to a trend analysis,
however, it is expected that, at this rate, the share should increase up to 100% in less than
15 years from now.
Another relevant aspect of the technological uptake relevant for the definition of the baseline
for this study is the percentage of EU27 population that uses a smartphone. This is
particularly relevant if the proposed electronic labels would require the use of these devices
able to scan and access data provided online.
According to the latest available data289
the percentage of EU27 population that accessed
internet with the use of a mobile phone was 71%. Lower shares for older groups of citizens
(i.e. 45% in the age group 55-74 years old). Also this indicator has shown a steady increase
in the last 10 years. However, the data in this case are also strongly influenced by the
availability on the market of mobile devices with internet capabilities.
These trends suggest that, in the next 10-20 years, the share of the population accessing the
internet via mobile phone will increase substantially. This assumption, however, does not
necessarily imply universal access or smartphone use: as mentioned by a consumer
organisation, people living in remote areas where internet is not available, or economic
reasons may mean that some population groups remain digitally excluded. Any regulatory
change, must therefore ensure that safety standards are not lowered, for any category of
stakeholder.
Technological uptake of enterprises
Digitalisation of businesses is a critical aspect for the uptake of electronic labels by
enterprises. As for consumers, the trends described below are related to the Commission’s
Megatrends Hub namely “Accelerating technological change and hyperconnectivity” .
Statistics show a small, but steady, increase of the share of companies that have a website.
More importantly, is the data on the percentage of enterprises that use their website to
288
Eurostat, Individuals - internet use [isoc_ci_ifp_iu]
289
Eurostat, Individuals - mobile internet access [isoc_ci_im_i]
378
provide description of goods and services and price lists amounts to 62% across all sectors,
and 76% for chemical manufacturers. This is a good indicator of the potential readiness of
businesses for the uptake of electronic labels.
Figure 81: Digitalisation of enterprises
Moreover, data from 2021 shows that 78%290
of businesses use websites to provide
information about their products or services and their prices. This share increases to 94%
amongst manufacturers of chemical products291
. In addition, 76% of manufacturers in the
chemical sector, provide online descriptions of their goods and/or price lists.
For what concerns digital tools and innovative communication methods, it is important to
take into account the following aspects:
1. Industry experience with online ingredient information: according to the
Detergents Regulation, manufacturers already have the obligation to publish on a
website the ingredient datasheet of their products. This means that manufacturers
already deliver activities related to the collection of information and publication of
these data online. The costs related to the collection of these information should not
be additional for the provision of electronic labels;
2. Increased market penetration of digital tools such as barcodes, QR codes and
websites to convey product information. This trend has increased the awareness of
consumers on the use of these tools. In particular, during the recent pandemic, QR
codes have been widely used, for example as an integral part of the EU Digital
COVID certificate. It can, therefore, be assumed that a large share of the population
is familiar with the use of this technology;
3. The GHS has embarked on defining a framework for digital labelling which
would be followed by implementation at EU level. Discussions started in 2019
regarding the possibility of digitalisation of information for chemical products.
Thus, even in the absence of a direct intervention at EU level now, digital labels
might eventually be introduced in the EU market through a revision of GHS
standards. Preparing EU businesses early will allow spreading investments over a
290
Digital economy and society statistics, Enterprises with a website [isoc_ciweb]
291
Digital economy and society statistics, Enterprises with a website [isoc_ciweb], Manufacture of chemicals
and chemical products (10 or more employees and self-employed persons).
0
10
20
30
40
50
60
70
80
90
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
Enterprises with a website (%)
Enterprises where the website provided description of goods or services, price lists (%)
379
longer period of time and provide a competitive advantages once the relevant GHS
standards become applicable;
4. Increased rules at EU level on communication of product information via
digital tools (i.e. for the labelling of wine , electronic instructions for use of medical
devices and digital labelling for batteries ), as well as the upcoming Digital Product
Passport (under the Sustainable Products Initiative) will set out the rules for digital
provision of suitability criteria of products. These parallel initiatives on the
introduction of digital labels in the EU suggest that electronic labelling would be
introduced for chemical products even if not directly related to a revision of the CLP
or Detergents regulations; and
5. The industry is already starting to voluntarily develop and use digital labels which
could lead to market fragmentation (i.e. a multitude of different systems at national
level or even at company level) if no common framework is established.
Chemical Sector Statistics
Analysis of the current size and magnitude of the chemical industry in the EU is crucial to
understand the market that is affected by the problems outlined in Chapter 2 and would be
subject to the policy options. The size and structure of this market will have a strong impact
on the economic costs and benefits that any regulatory intervention entails. As described in
more detail in the tables below, throughout the EU, there are over 21 thousand chemical
enterprises, directly employing over a million of EU citizens and generating over a billion
EUR of turnover annually. These statistics, however, do not take into account the businesses
that are indirectly linked to the chemical industry, either up- or downstream in the supply
chain (e.g. retailers) and should therefore be seen as a very conservative estimate of the
market size.
For the analysis conducted in this study, in particular concerning impacts on costs, the
sectors in scope are the ones subject to CLP and Detergents Regulations, in particular
manufacturers of chemicals and chemical products (NACE C20), manufacturers of coke
and refined petroleum products (NACE C19), manufacturers of rubber and plastic products
(NACE C22).
In particular, according to the NACE rev.2 classification, the sectors in scope are:
Manufacture of refined petroleum products (CLP)
Manufacture of other inorganic basic chemicals (CLP)
Manufacture of other organic basic chemicals (CLP)
Manufacture of plastics in primary forms (CLP)
Manufacture of synthetic rubber in primary forms (CLP)
Manufacture of paints, varnishes and similar coatings, printing ink and mastics
(CLP)
Manufacture of soap and detergents, cleaning and polishing preparations (CLP and
Detergents)
Manufacture of explosives (CLP)
Manufacture of glues (CLP)
Manufacture of essential oils (CLP)
Manufacture of other chemical products n.e.c (CLP).
380
Manufacture of basic iron and steel and of ferro-alloys (CLP)
The table below presents market data in terms of the number of enterprises, turnover,
production value, value added and persons employed.
381
Table 110: Chemical sector statistics 2018
Enterpr
ises -
number
Turnove
r -
million
euro
Production
value -
million euro
Value added at
factor cost -
million euro
Persons
employed -
number
Manufacture of refined
petroleum products
814 457.631,
4
381.931 30.119,7 161.678
Manufacture of other
inorganic basic chemicals
912 26.166,5 24.620 7.651,0 63.508
Manufacture of other organic
basic chemicals
1.885 185.876,
6
159.483 44.264,4 224.137
Manufacture of plastics in
primary forms
2.263 99.386,4 92.239 18.892,0 133.112
Manufacture of synthetic
rubber in primary forms
179 4.755,5 4.569 1.167,2 7.225
Manufacture of paints,
varnishes and similar coatings,
printing ink and mastics
3.356 41.987,8 37.859 11.266,8 150.384
Manufacture of soap and
detergents, cleaning and
polishing preparations
3.877 21.903,4 19.855 5.904,9 85.544
Manufacture of explosives 501 2.080,6 1.936 830,2 12.983
Manufacture of glues 481 4.360,8 3.962 1.152,7 13.977
Manufacture of essential oils 773 7.379,7 7.085 2.257,7 20.655
Manufacture of other chemical
products n.e.c.
3.968 62.203,8 52.499 15.230,5 119.762
Manufacture of basic iron and
steel and of ferro-alloys
2.616 161.636,
4
159.856 29.308,0 331.670
Source: Eurostat
Amongst the sectors in scope, the manufacture of chemicals and chemical products is the
largest with a total number of enterprises close to 28.000 in 2018. Most of these companies
are SMEs as shown in the table below.
382
Table 111: Number of enterprises by size (2018)
Enterprise number Total From 0 to
9 persons
employe
d
From 10
to 19
persons
employe
d
From 20
to 49
persons
employe
d
From 50
to 249
persons
employe
d
250
persons
employe
d or more
Manufacture of coke and
refined petroleum products
868 522 92 97 78 79
Manufacture of chemicals
and chemical products
27.986 19.447 2.732 2.510 2.504 793
Manufacture of basic
chemicals, fertilisers and
nitrogen compounds,
plastics and synthetic
rubber in primary forms
8.346 5.549 813 793 861 330
Manufacture of paints,
varnishes and similar
coatings, printing ink and
mastics
3.356 1.998 468 408 364 119
Manufacture of soap and
detergents, cleaning and
polishing preparations,
perfumes and toilet
preparations
9.765 7.568 793 617 609 178
Manufacture of other
chemical products
5.723 3.863 586 607 549 119
Source: Eurostat
Baseline scenario
Under the baseline scenario no further policy intervention would be introduced. The purpose
of the baseline is to have a comparison for the estimate for the impacts of the other policy
options and assess the costs and benefits of the “status quo” to which other policy options
are compared to.
The findings of a legal analysis, the interviews, and the behavioural experiment, conducted
under the VVA 2021 study on digital labelling292
, findings indicate that the labelling
requirements of the CLP Regulation are still relevant in fulfilling their objective of
communicating hazard and safety information as well as use instructions to users. More
specifically, the legal analysis shows that the labelling provisions of the Detergents
Regulation are “without prejudice” to the provisions of the CLP and, where applicable, they
will be added to the CLP requirements.
For what concerns digital tools and innovative communication methods, it is important to
take into account the following aspects:
292
VVA (2022) Impact Assessment Study on the simplification of the labelling requirements for chemicals
and use of e-labelling
383
1. The increased market penetration of digital tools such as barcodes, QR codes and
websites to convey product information. This trend has increased the awareness of
consumers on the use of these tools. In particular, during the recent pandemic, the
use of QR codes has been widely used, for example as integral part of the EU Digital
COVID certificate.293
2. The GHS has embarked on defining a framework for digital labelling. Potentially,
in case of a definition of an international GHS framework on digital labelling, a
subsequential implementation at EU level would follow up. Discussions have started
in 2019 regarding the possibility of digitalisation of information for chemical
products.294
Development on this topic suggest that, even in absence of a direct
intervention at EU level, the use of digital labels will have to be introduced in the
EU market though a revision of the GHS standards.
3. Increased rules at EU level of the communication of product information via digital
tools (i.e. for the labelling of wine295
, electronic instructions for use of medical
devices296
and digital labelling for batteries297
), as well as the upcoming Digital
Product Passport (under the Sustainable Products Initiative)298
which will set out the
rules of digital provision of suitability criteria of products. Parallel initiatives on the
introduction of digital labels in EU suggest that electronic labelling could be
introduced in EU for chemical products even if not directly related to a revision of
the CLP or Detergents regulations;
4. The industry is already starting to develop and use digital labels which could lead to
market fragmentation (i.e. a multitude of different systems at national level or even
at company level) if no common framework is established.
All of these developments point towards the fact that digital labels will be necessary in the
future to present and/or sell products online, and that therefore, the costs to develop these
293
EU Digital Covid Certificate: https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/safe-
covid-19-vaccines-europeans/eu-digital-covid-certificate_en
294
(AC.10/C.4) ECOSOC Sub-Committee of Experts on the Globally Harmonized System of Classification
and Labelling of Chemicals (38th session). Report available at: https://unece.org/info/events/event/19153
295
Regulation (EU) 2021/2117 of the European Parliament and of the Council of 2 December 2021 amending
Regulations (EU) No 1308/2013 establishing a common organisation of the markets in agricultural products,
(EU) No 1151/2012 on quality schemes for agricultural products and foodstuffs, (EU) No 251/2014 on the
definition, description, presentation, labelling and the protection of geographical indications of aromatised
wine products and (EU) No 228/2013 laying down specific measures for agriculture in the outermost regions
of the Union, available at: https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX%3A32021R2117&qid=1645715904558
296
COMMISSION IMPLEMENTING REGULATION (EU) 2021/2226, of 14 December 2021, laying down
rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards
electronic instructions for use of medical devices, available at: https://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32021R2226
297
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
concerning batteries and waste batteries, repealing Directive 2006/66/EC and amending Regulation (EU) No
2019/1020, COM/2020/798 final, available at: https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX%3A52020PC0798&qid=1639045049210
298
Work in progress, for more information please see: https://ec.europa.eu/info/law/better-regulation/have-
your-say/initiatives/12567-Sustainable-products-initiative_en
384
digital labels will occur in any event. However, without a common framework at EU level,
the market fragmentation would likely lead to higher costs.
Regarding the use of e-labels, this policy option would foresee no changes in the status quo
meaning that industry would continue to provide mandatory information on physical labels.
Manufacturers would continue to adopt e-labels according to their own preferences and with
no specific measure regarding the type of IT solution to be used, or the quality of
information provided.
Physical vs electronic label under the baseline
In the current regulatory framework, the use of electronic labels is not regulated, thus,
manufacturers are not allowed to replace (partially or totally) the physical labels with
electronic ones.
The use of e-labels is voluntary and not regulated. As previously mentioned, however, some
requirements already exist for duty holders that are relevant for our analysis, in particular:
Safety Data Sheets that need to contain the labelling information of the CLP Regulation
pursuant to Article 31 of the REACH Regulation need to be provided by suppliers who place
a substance or mixture on the market299
; This is increasingly (but not always) done in an
electronic manner;
Under Article 40 of CLP, manufacturers or importers, or a group of manufacturers or
importers, are obliged to notify information to the European Chemicals Agency (ECHA) on
the substances they place on the market;
Under Article 45 of CLP, downstream users and importers are obliged to notify nationally
or to ECHA relevant information to provide emergency health response, which shall be
received by national appointed bodies (poison centres).
These processes involve largely or fully the digital processing and/or communication of
labelling elements. Therefore, we assume that there is already an “administrative burden”
related to notifications to be carried out electronically for duty holders due to the provision
of information under CLP Articles 40 and 45 to a public authority. This implies at least that
duty holders have the relevant labelling elements on the substances and mixtures they place
on the market already available in an electronic format and that it is unlikely that additional
significant cost for digitalisation of physical labels will occur.
Description of Policy Measures
The legal analysis, the interviews and the behavioural experiment provided the basis for the
identification of the policy options to simplify and streamline current labelling
requirements, and to introduce the use of digital tools for parts of the labels falling within
the scope of CLP and the Detergent Regulations.
299
See Article 31 of the REACH Regulation read in combination with Annex II of that Regulation.
385
Policy measure 0: No new policy actions
Under this measure, no further policy intervention would be introduced. The purpose of the
baseline is to establish a benchmark against which the impacts of the other policy options
can be compared,
The findings of the legal analysis, the interviews, and the behavioural experiment, indicate
that the labelling requirements of CLP are still relevant in fulfilling their objective of
communicating hazard and safety information to users. The legal analysis suggests that the
labelling requirements of the two Regulations (detergents and CLP) complement each other
as both Regulations aim to protect the health of consumers, industrial and professional users.
Indeed, as described above, the European chemical legislation is spearheaded by the
REACH Regulation and the CLP Regulation which are setting the science-based horizontal
legislative framework, and complemented by sector specific legislation (e.g. the Detergents
Regulation), using the general framework to establish risk management measures as
necessary.
However, some legislative overlaps between the CLP and the Detergents Regulations exist,
notably regarding the labelling of allergenic fragrances, the labelling of surfactants and
allergenic preservatives when CLP thresholds are met. These overlaps may create
duplications in labelling requirements and consequently, redundant information that reduce
the readability of a label and confuse users. For instance, labels of detergents, falling by
default under both regulations, contain a duplication in labelling of substances (e.g.
allergenic fragrances), and in addition they need to be indicated under different names (INCI
names for preservatives and allergenic perfume ingredients according to Detergents
Regulation, and chemical names according to CLP). More details on the regulatory overlaps
are provided in the regulatory analysis in Annex 3.
Regarding the use of digital labels, this policy option would foresee no changes in the status
quo meaning that industry would continue to provide mandatory information on physical
labels. Manufacturers would continue to adopt digital labels according to their own
preferences and with no specific measure regarding the type of IT solution to be used, or
the quality of information provided, possibly even using proprietary systems that are
incompatible with other systems used.
Physical vs electronic label under the baseline (option 0)
In the current regulatory framework, the use of electronic labels is not regulated, thus,
manufacturers are not allowed to replace (partially or totally) the physical labels with
electronic ones.
The use of digital labels is voluntary and not regulated. As previously mentioned, however,
some requirements already exist for duty holders300
that are relevant for our analysis, in
particular: the Safety Data Sheets, notifications to ECHA, providing information for
emergency health response and the obligations under the Detergents Regulation to make
some information available on a website.
300
Manufacturers, suppliers, importers, and downstream users of the products defined in the CLP and
Detergents Regulations.
386
These processes involve largely or fully the digital processing and/or communication of
labelling elements. Therefore, we assume that there is already an “administrative burden”
related to notifications to be carried out electronically for duty holders due to the provision
of information under CLP Articles 40 and 45 to a public authority and a substantive cost of
setting up a dedicated website due to Annex VII to the Detergents Regulation.
Furthermore, it is expected that the Digital Product Passport will already lead to the
development of relevant databases and communication platforms that could be re-used for
digital labelling elements under CLP and the Detergents Regulation.
Table 112: Policy measure 1: Non-legislative measures: Physical labels and voluntary use of e-label
Summary
Policy Measure 1: Non-legislative intervention which foresees no changes in the current mandatory regulatory
framework.
The intervention of the European Commission would be limited to the provision of a guidance document which would
set non-mandatory standards (e.g. on how to present information) on the voluntary use of electronic labels (e.g. with
recommended practices for better readability of information on the electronic label).
Manufacturers would not be allowed to replace (partially or in total) physical labels with electronic ones.
This option might also include the promotion of information campaigns on chemicals in consumer products to improve
consumer understanding of dangers and information available on labels.
Intervention:
Policy measure: to create a new section/heading under ECHA’s Labelling and Packaging Guidance with
recommendations on the implementation of existing labelling requirements and effective communication for
digital labelling.
Under Policy Measure 1, only non-legislative action to set out common practices in the
implementation of existing labelling requirements will be taken. It should be noted that
guidance documents were already developed by ECHA on the CLP Regulation301
. While
this guidance is appropriate it may be necessary to widen the communication efforts about
the guidance to stipulate its use. In the next review of the guidance it could also be explored
to elaborate further on the interaction between CLP and other relevant legislation such as
the Detergent Regulation.
Commission or ECHA guidelines could provide more practical examples and informal notes
on how to convey obligatory information (under the CLP Regulation) on the label without
overwhelming users, in particular consumers, for example by simplifying and streamlining
labels. However, such solutions would not remove any regulatory overlaps or
inconsistencies as such. Furthermore, such guidelines could include best practices examples
of the interplay between the CLP and the Detergent Regulations regarding labelling
provisions. Nevertheless, such solution would not remove any regulatory overlaps or
inconsistencies as such.
Regarding the use of digital labelling, the current legal labelling requirements do not allow
duty holders to provide information only digitally, and digital communication on product
labels is done only on a voluntary basis and supplementary to the physical label. Considering
301
ECHA, Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008, March
2021. https://echa.europa.eu/documents/10162/23036412/clp_labelling_en.pdf/89628d94-573a-4024-86cc-
0b4052a74d65
387
the opinions expressed so far in the Sub-Committee of the GHS, it likely that this will remain
the norm for CLP.
However, guidelines and good practices examples on effective communication for digital
labelling could support the industry in the uptake of digitalisation on a voluntary basis, e.g.
to respond to market demands.
Regarding how to provide the above mentioned guidelines on how to convey obligatory
information on the label and on effective communication for digital labelling, Policy
Measure 1 considers to create a new section/heading under ECHA’s Labelling and
Packaging Guidance302, designed to assist manufacturers in the effective application of the
CLP Regulation, with new recommendations. As they are now, these guidelines provide a
general overview of the CLP Regulation with explanations of the requirements for labelling
and packaging, as well as practical examples illustrating different situations that may be
encountered when designing labels. With this policy measure, this document could be
completed with additional recommendations, especially on how to convey obligatory
information without overwhelming users (and especially consumers), thus increasing the
efficiency of the hazard communication to users without modifying the legal requirements.
This additional guidance would aim to tackle the issue of the overloaded character of labels
and the long texts in small prints, which, as highlighted by a majority of stakeholders during
the interviews, reduce the readability and understandability of labels.303 In addition,
ECHA’s Labelling and Packaging guidance could also include practical examples of
effective communication for digital labelling, in order to incentivise a voluntary but
standardised way of communicating information digitally. This part of the policy measure
would address the objective (SO2) of setting up a framework allowing the use of digital
tools to communicate product information. However, it must be noted that with this policy
measure, this guidance would constitute a non-regulatory framework. Policy Measure 2:
Revision of the labelling rules in the regulations: align the two regulations and address
inconsistencies on the physical label only.
302
ECHA, Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008, March
2021. https://echa.europa.eu/documents/10162/23036412/clp_labelling_en.pdf/89628d94-573a-4024-86cc-
0b4052a74d65
303
See Annex 1, Stakeholder consultation - Synopsis report, findings from the interviews.
388
Table 113: Policy Measure 2: Revision of the labelling rules in the regulations
Summary
Policy Measure 2: This policy measure would entail a regulatory intervention when revising the Detergents
regulations to address inconsistencies, overlaps and duplications (also with CLP).
This policy measure would not entail any possibility for manufacturers to replace (partially or in total) physical labels
with electronic ones and the use of electronic labels would remain voluntary and with the provision, at EU level, of
guidelines on the use of digital tools.
 Interventions on CLP Regulation: None.
 Interventions on Detergents Regulation:
o Sub-measure 2a: the Detergents Regulations provides that the identified overlapping provisions are
to be labelled only once, either following the CLP or Detergents Regulation, based on the stricter
rules;
Sub-measure 2b: all overlapping provisions are removed from the Detergents Regulation.
This policy measure would entail a regulatory intervention when revising the Detergents
Regulation to address the identified legal overlaps, inconsistencies and duplications. This
policy option contribute to the achievement of the first specific objective identified (SO1),
to improve consumer understanding and awareness of labels, especially for vulnerable
consumers, by simplifying and streamlining the existing labelling requirements in the
Detergents Regulation only.
This policy measure would not entail any possibility for manufacturers to replace (partially
or in total) physical labels with digital ones, and the use of digital labels would remain
voluntary and with the provision, at EU level, of guidelines on the use of digital tools (as
described under Policy measure 1).
This policy measure would not necessitate any regulatory interventions on the CLP
Regulation. The legal overlaps, inconsistencies and duplications identified would be
addressed with a regulatory intervention when revising the Detergents Regulation. Although
no regulatory changes would be made to the CLP regulation, addressing the issues in the
Detergents Regulation, will address overlaps identified in both Regulations.
First, labelling requirements under the Detergents Regulation that would need to be
streamlined to avoid overlaps, inconsistencies and duplications with the CLP Regulation.
These regulatory changes include the following:
Where labelling provisions of CLP (hazard pictograms, hazard statements, precautionary
statements, etc.) fulfil the requirements of the Detergents Regulation, Article 11(3), the
standard phrases under the CLP Regulation would be used to warn consumers, industrial
and professional users;
Ensure that for mixtures the provisions of Annex VII C of the Detergents Regulation do not
duplicate those of Article 45 and Annex VIII of the CLP;
Secondly, this policy measure aims to simplify and clarify the rules on labelling of allergenic
fragrance ingredients in a way that the same fragrance ingredient falling within the scope of
both Regulations is not labelled twice or thrice on the same label. This simplification should
also consider the existing differences between the two Regulations in the identification of a
389
substance, i.e., the name (and identification number) under which the sensitising fragrance
is to be labelled. To this purpose, this policy option is declined under two sub-options, as
follows:
Sub-measure 2a: the Detergents Regulations provides that the remaining overlapping
provisions are to be labelled only once, either following the CLP or Detergents Regulation,
based on the stricter rules;
Sub-measure 2b: all overlapping provisions are removed from the Detergents Regulation.
These overlaps concerns the inclusion of skin sensitisers (i.e. allergenic substances like
preservatives and fragrances) in the list of ingredients that need to figure on the product
label when they are present above certain thresholds, considering that most allergenic
fragrance ingredients under the Cosmetic Products Regulation are also classified as skin
sensitisers under CLP. These thresholds in CLP are lower than those provided in the
Detergents Regulation. Therefore, according to sub-measure 2a, when these substances are
present in a detergent, they should be labelled according to the stricter rules provided in the
Detergents Regulation (i.e. labelled as soon as the lowest threshold is reached). However,
in the sub-measure 2b, the labelling requirements concerning the allergenic fragrance
ingredients will be removed from the Detergents Regulation and when these substances are
present in a detergent, they would be labelled according to the CLP Regulation. To this
regard, in sub-measure 2b, less allergenic substances would be labelled (due to higher
thresholds to reach).
The analysis and impacts of this policy measure are included in the parallel Staff Working
Document of the Detergents Regulation targeted revision.
Policy measure 3: Revision of the labelling rules in the regulations, introducing digital
labelling: keep basic information of labelling requirements on physical labels, and move
certain labelling requirements on the digital label only.
390
Table 114: Policy measure 3
Summary
Policy measure 3: This policy measure would entail a regulatory intervention to allow manufacturers to use
electronic labels, on a voluntary basis, to provide specific pieces of information to users in alternative to physical labels.
This policy measure does not allow for a complete replacement of the physical label. Still, it will enable manufacturers
to provide some mandatory details online while keeping basic mandatory information on the physical label.
From Policy measure 3 onwards, the policy options would also include the regulatory interventions discussed under
Policy measure 2 to streamline the regulatory framework under the Detergents Regulation.
In addition, this policy measure would entail the introduction of a common framework for digital labelling in each
piece of legislation (i.e. in the CLP and Detergents Regulation, but also in other legislation such as the Fertilising
Product Regulation). This common framework for digital labelling would need to be kept aligned between the relevant
legislation. Such a framework would include mandatory principles on the provisions of this information to ensure
higher consumer protection standards. Such principles would need to be common to all digital labelling solutions.
Labelling requirements under the CLP regulation that would be allowed to be moved on a digital label under Policy
measure 3:
o Supplemental labelling information:
a) EUH statements as per sections 1.1. and 1.2. of Annex II (Art. 25(1))
b) Other supplemental labelling information than that in paragraphs (1) and (2) of Art. 25 (Art. 25(3))
c) EUH statements as per Part 2 of Annex II for certain mixtures (Special rules for supplemental label
elements for certain mixtures, Art. 25(6))
This policy measure is the first to introduce the possibility for duty holders to partially
replace physical labels with digital labels for the provisions of some specific pieces of
information which are currently mandatory. Providing information electronically would
remain voluntary.
From Policy measure 3 onwards, the policy options also include the regulatory interventions
foreseen under Policy measure 2 in the Detergents Regulation, which are needed to
streamline the regulatory framework and remove inconsistencies and duplications.
It must be noted that the framework for digital labelling would need to be introduced in each
piece of legislation (i.e. in the CLP and Detergents Regulation, but also in other legislation
such as the Fertilising Product Regulation). This common framework for digital labelling
would need to be kept aligned between the legislation. Alternatively, the framework for
digital labelling could also be included in CLP, with downstream legislations (e.g. the
Detergents Regulation) making reference to these overarching rules. This option would
allow the digital labelling framework to remain consistent over time and the potential
revisions without having to amend each downstream legislations.
The possibility for manufacturers to adopt digital labels would also require the introduction
of mandatory principles on the provisions of this information to protect end-users and to
ensure the accessibility and the availability of the digital information. Such principles
should ensure accessibility of information and further assist in enforcing the rules.
Digital labelling should at least comply with the following general requirements:
391
The obligation for the digital label to include the full set of labelling information (i.e. there
should not be a split of information between the physical and digital label), to ensure that
the information provided online is meaningful;
The obligation to provide all digital data in one place, separately from other commercial
information (e.g. the mandatory information shall not be displayed together with other
information intended for sales or marketing purposes). Coherence should also be sought
with other digital provision of information of products (e.g. under the Digital Products
Passport);
The format of the data provided digitally must be appropriate (e.g. rules on font size, the
content of the digital label must be searchable);
The protection of personal data (e.g. prohibition of collecting and tracking user data or using
that information for commercial purposes) in accordance with Regulation (EU) 2016/679304
;
Accessibility of the data both in terms of ease of access (e.g. “two-click” maximum rule to
access the information), and in terms of accessibility for users (e.g. also for users with
disabilities). Access to the digital label must be free and without a need for prior registration
or a password, or prior download of applications. Access limitations for certain user groups
(e.g. geo-blocking in accordance with Regulation (EU) 2018/302305
) are not allowed;
Minimum technical requirements are to be complied with, in order to ensure technological
neutrality of IT solutions used. The IT solution must be easily readable via widely used
digital technologies. It must be ensured that the data can be accessed, navigated and read
on, and is compatible with all major operating systems and browsers. Information must also
be available for old browser version and operating systems;
The information must be provided equally in all official languages of the EU Member States
in which the product is marketed. Additional languages are permitted; Users must have the
possibility to select their language of choice, regardless of their physical location.
Appropriate alternative ways of providing information must be available in case of lack of
digital tools or skills, or in the absence of network access (e.g. a print-out label at the point
of sale);
The IT solution must be printed or placed physically, visibly and legibly on the product.
When appropriate under the overall labelling requirements of the product in question, where
this is not possible or not warranted on account of the nature and size of the product, the IT
solution shall be affixed to the documents accompanying the product.
304
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection
of natural persons with regard to the processing of personal data and on the free movement of such data, and
repealing Directive 95/46/EC (General Data Protection Regulation): https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX%3A02016R0679-20160504
305
Regulation (EU) 2018/302 of the European Parliament and of the Council of 28 February 2018 on
addressing unjustified geo-blocking and other forms of discrimination based on customers' nationality, place
of residence or place of establishment within the internal market and amending Regulations (EC) No
2006/2004 and (EU) 2017/2394 and Directive 2009/22/EC: https://eur-lex.europa.eu/legal-
content/EN/ALL/?uri=CELEX%3A32018R0302
392
The data contained under the digital label must remain accessible as long as the product that
it refers to, are sold and used in the European Union, or as long as the conformity assessment
documentation is required to be kept, where relevant. The data present on the digital label
must remain available even after the bankruptcy, the liquidation or the cessation of activity
in the EU of its originator;
Further, the overarching principle that guides the selection of what information could be
moved to an online label is to ensure that it does not lower the level of safety and therefore
decrease consumer protection. In this regard, the results of the behavioural experiment show
that a simplified label can perform, in terms of consumers’ safety, as well as the current
physical labels.
Commitments of the EU under GHS limit the option to move information exclusively to the
digital label because GHS mandates the use of a physical label. Statements made during the
discussions on a digitalisation framework suggest that the presence of the information on a
physical label is considered essential for safety and it is currently considered unlikely that
the future GHS framework on digitalisation would change that.
Labelling requirements under the CLP regulation that would theoretically be allowed to
be moved on a digital label under Policy measure 3 are the supplemental labelling
information306
, as provided in Article 25 of the CLP Regulation (as this information as not
covered by GHS). More specifically, these would include:
 EUH statements as per sections 1.1. (physical properties) and 1.2. (health properties)
of Annex II of the CLP regulation. These include statements that shall be assigned
in accordance with Article 25(1) to substances and mixtures classified for physical,
health, or environmental hazards.
 Other supplemental labelling information, in accordance with Article 25(3). These
include supplemental information included by the supplier to provide further details
on the label elements referred to in Article 17(1) (a) to (g), i.e. the name, address,
and telephone number of the supplier(s), the nominal quantity of the substance or
mixture, the product identifiers, the hazard pictograms, the signal words, the hazard
statements, and the appropriate precautionary statements.
 According to Article 25(6), EUH statements as per Part 2 of Annex II for certain
mixtures containing any substance classified as hazardous.
However, it must be noted that this does not concern the supplemental information coming
from other legislation (e.g. biocides, ODS).
Policy measure 4: Revision of the labelling rules in the regulations, introducing digital
labelling: further simplify physical label, and move additional information on the digital
label
Table 115: Policy measure 4
306
This does not include the supplemental information coming from other legislation (e.g. Biocidal Product
Regulation).
393
Summary
Policy measure 4: Similar to policy measure 3, policy measure 4 would entail a regulatory intervention to allow
manufacturers to use electronic labels, on a voluntary basis, to provide specific pieces of information to users in
alternative to physical labels.
As provided under Policy Measure 3, Policy measure 4 would also include the regulatory interventions discussed under
Policy measure 2 to streamline the regulatory framework under the Detergents Regulation.
In addition, as under Policy Measure 3, this policy option would entail the introduction of a common framework for
digital labelling in each pieces of legislation, as well as common principles on the provisions of this information to
ensure higher consumer protection standards.
This policy measure does not allow for a complete replacement of the physical label. Still, it will enable manufacturers
to provide mandatory details online while keeping basic mandatory information on the physical label.
Policy measure 4 would be a further extension of the possibilities offered to manufacturers under policy option 3 to
provide additional information on a digital label.
Regarding the labelling requirements under the CLP Regulation, Policy Measure 4 foresees that in addition to the
information allowed to be provided online under Policy Measure 3, the list of information that could be provided only
online is extended to:
Hazard statements (Art. 21 CLP);
Precautionary statements (Art. 22 CLP).
The Policy Measure would also include the regulatory interventions discussed under Policy
measure 2 to streamline the regulatory framework under the Detergents Regulation.
This policy option foresees the possibility for manufacturers to introduce additional
information, further to that specified under Policy measure 3.
From a legal point of view and in the context of the CLP Regulation, Policy measure 4
would deviate from the GHS quite significantly in the context of CLP labelling. Therefore,
it must be emphasised that this policy option is included in order to assess the impacts of its
policy measures, as put forward by stakeholders, but is unlikely to be implemented under
the revision for the CLP regulation.
As provided under Policy measure 3, this policy measure would entail the introduction of a
framework for digital labelling in each pieces of legislation (i.e. in the CLP and Detergents
Regulation, but also in other legislation such as the Fertilising Product Regulation). This
common framework for digital labelling would need to be kept aligned between the
legislation.
The possibility for manufacturers to adopt digital labels would also require the introduction
of mandatory principles on the provisions of this information to ensure higher consumer
protection standards. Such principles (as developed in Policy measure 3) would need to be
common to all digital labelling solutions.
Regarding the information that could be provided digitally, Policy measure 4 includes the
labelling information as provided and described in Policy measure 3. In addition, under
Policy measure 4, the list of labelling requirements from the CLP Regulation that could be
provided only online is extended to the following:
 The relevant hazard statements, as per Article 21 of CLP;
 The relevant precautionary statements, as per Article 22 of CLP.
394
Policy measure 5: Revision of the labelling rules in the regulations, introducing digital
labelling: In specific cases, option of providing all information on digital label
Table 116: Policy measure 5
Summary
Policy measure 5: This policy measure entails the possibility for manufacturers of providing
mandatory information exclusively on electronic labels in specific cases and/or specific products
(e.g. products which are sold without original container, or products for which a container is too
small to physically include all mandatory information).
As provided under policy measure 3, Policy measure 5 would also include the regulatory
interventions discussed under Policy measure on 2 to streamline the regulatory framework under
the Detergents Regulation.
In addition, similarly to policy measure 3, this policy measure would entail the introduction of a
common framework for digital labelling in each piece of legislation, as well as mandatory
principles on the provisions of this information to ensure higher consumer protection standards.
Regarding the products falling under the CLP Regulations, this option should be assessed only
for:
 Re-fill chemicals (e.g. , detergents, fuels to be filled in jerry-cans (not in tanks), paints
etc.)
 Writing instruments including hazardous inks (pens, highlighters etc.)
 Lighters
Under Policy Measure 5, in addition to the previous policy option, manufacturers would be
allowed, for some specific products or types of sale, to provide the mandatory information
under the CLP and Detergents Regulations exclusively on digital labels.
As provided under Policy measure 3, this policy option would also include the regulatory
interventions discussed under Policy measure 2 to simplify and streamline the regulatory
framework under the Detergents Regulation. It also entails the introduction of a framework
for digital labelling in each pieces of legislation (i.e. in the CLP and Detergents Regulation,
but also in other legislation such as the Fertilising Product Regulation). This common
framework for digital labelling would need to be kept aligned between the legislation.
The possibility for manufacturers to adopt digital labels would also require the introduction
of mandatory principles on the provisions of this information to ensure higher consumer
protection standards. Such principles (as developed in Policy measure 3) would need to be
common to all digital labelling solutions.
This policy measure applies only to products where the packaging is either in such a shape
or form or is so small that it is impossible to meet the labelling elements under Article 17
(products falling under Art. 29(1) of CLP, where the label elements may be provided on
fold-out labels, tie-on tags, outer packaging”). Such a change would require a specific
labelling provision for those products. In practice these products are currently very often
not labelled at all, despite the legal obligations due to practical difficulties to comply with
the rules. While allowing for digital labelling in those cases would not offer the same level
of protection compared to a physical label, it would increase the safety level compared to
the de-facto absence of a label.
395
As these products usually contain only very small amounts of hazardous substances and
contact with them is limited, a digital label may be an acceptable compromise between
consumer protection and the additional cost to ensure appropriate labelling, which would in
the end result into higher consumer prices. In addition, enforcing proper labelling would in
most cases mean that the products would need to be individually packaged thus creating a
huge amount of packaging waste that may in turn increase the environmental and climate
footprint of the product.
Regarding the labelling requirement set up in the CLP, Policy measure 5 considers the
possibility to provide all mandatory labelling requirements digitally for the following
specific products only:
 Re-fill chemicals: detergents, fuels to be filled in containers (not in tanks), paints;
 Writing instruments (e.g. pens, highlighters etc.);
 Lighters.
The problems related to the labelling of those items are discussed exhaustively in Annex
12. This policy measure will, therefore, be significantly influenced by the policy option and
measure selected under that the general CLP labelling rules.
DESCRIPTION OF IMPACTS
In alignment with the provisions of the Better Regulation Toolbox, the first step in the
assessment of impacts is the identification of all relevant impacts under the different policy
options. The identification of the impacts is based on data and information collected during
the previous tasks (i.e. interviews, behavioural experiment, survey and analysis of OPC
responses). The research collected qualitative information and quantitative data on social,
economic and environmental impacts related to the identified policy options.
Socio-economic and environmental impacts identified have been categorized according to
the following criteria:
 Economic impacts, in particular focusing on conduct of business (BR Tools #21-
25), sectoral competitiveness, trade and investment flows (BR Tools #21, 27),
impact to the SMEs (BR Tool #21), technological development / digital economy
(BR Tool #28), and impact to public authorities (BR Tool #58);
 Social impacts, focusing consumers and households (BR Tool #33);
 Environmental impacts, in particular focusing on sustainable consumption and
production (BR Tool #36).
The impacts that have been taken into account for this analysis are considered to be the most
relevant and the ones for which consulted stakeholders were able to provide insights. A
dedicated survey targeting public authorities, consumer organisations and industry
representatives (associations and businesses), presented the individual policy options and
asked participants to provide a direct feedback. The opinions of stakeholders have been
triangulated with other data sources used in the study.
This section provides an assessment for each identified impact that is relevant to the
assessment of the options and the identification of a preferred option.
Table 117: Assessment of impacts
396
Colour
coding
-- - O + ++ U
Qualitative
Strongly
negative
Weakly
negative
No or
limited
impact
Weakly
positive
Strongly
positive
Undefined
Policy measure 0: No new policy measures
The status quo has been extensively discussed in the previous chapters. This analysis
highlighted the following issues:
There are a number of overlaps and inconsistencies in the labelling requirements
between CLP, Detergents and other relevant legislative acts;
In some cases, there are difficulties for consumers to understand information
provided by labels.
In addition, the current legal (mandatory) requirements do not incentivise the use of more
innovative techniques and digital tools (i.e. digital labelling) and when it happens, industry
uses these digital tools on a voluntary and unharmonised basis, in addition to the physical
labels required by law.
This policy measure would not address any of the problems identified in Chapter 2 and it
would continue to lead to improper use of detergents by consumers, burdensome
administrative activities for businesses and a wrongful disposal of chemical products that
can be harmful for the environment. Moreover, this policy measure is not in parallel with
recent market developments and ongoing initiatives in the EU described in more detail in
chapter 5.1.4, “other policy developments” of the SWD, that aim to promote the use of
digital labels and reduce the severity of some of the problems identified in Chapter 2.
Taking into consideration the previously mentioned issues, stakeholders have been
consulted regarding their overall assessment of the current regulatory framework (CLP and
Detergents) with the objective of having a benchmark to assess the proposed policy options.
The overall opinion of the consulted stakeholders on the status quo is not particularly
positive, with public authorities having a slightly more positive view than industry
stakeholders307
.
Table 118: Economic impact assessment Policy Measure 0
Type of impact Assessment Score
Conduct of business
(Tools #21-25)
Based on the findings from the behavioural experiment, according to 90% of
consulted representatives of Public Authorities and 70% of industry
representatives, the information currently provided on labels and SDS are
adequate to ensure a safe use of products. Very few respondents (6%) gave a
negative opinion. Findings from the online survey for professionals and industry
users strongly support this argument as 74% of respondents from industry think
that information currently provided on labels is easy to understand and only 10%
of professional and industry users think that information provided on product
packaging is difficult to understand. Taking into consideration of these results,
Weakly
negative
307
Based on the findings from the online survey on Policy Options. On a scale from -5 to 5, 12 survey
respondents belonging to public authorities, on average, have rated the current framework as fairly positive
(2.5), while 54 respondents from the industry, on average, have rated the status quo as fairly negative (-1.5).
397
Type of impact Assessment Score
professional users are overall content with the pieces of information currently
available on the labels and the understandability of this information.
Industry respresentative pointed out that frequent legislative changes incur
annual cost for disposal of old labels which are considered by a large majority
of the industry stakeholders (70%, 27 out of 38) as high or very high. Companies
that have provided estimates mentioned that, in total, these costs reach up to 1
% of annual turnover. I should be noted though that changes in CLP that affect
the classification of chemicals always come with a transition period during
which old labels can still be consumed. Furthermore, labelling changes are not
only triggered by legislation but also done for marketing purposes. The
information provided did not allow to distinguish what factors exactly are
causing the costs mentioned.
Sectoral
competitiveness,
trade and investment
flows (Tool #21, 27)
This policy measure should have no particular impact for the competitiveness of
the industry considering that it would not entail any regulatory change and the
provision of information would still remain on physical labels and safety data
sheets.
Neutral
SMEs (Tool #21) This policy measure does not have any specific impact on SMEs as cost of
conducting business for SMEs would remain unchanged.
Neutral
Technological
development /
Digital economy
(Tool #28)
Amongst industry respondents to our survey comparing the policy options (in
large part, large enterprises), 60% indicated to be using a form of digital tool
(e.g. QR codes) to provide information to consumers and 90% see the use of
such tools positively.
Businesses in the chemical industry are already highly involved in using digital
tools to provide information to the consumers. The absence of regulatory support
to foster the transition towards digital labelling tools could thus have negative
consequences on the development of the digital economy.
Under Policy measure 0, in the same survey, stakeholders were asked to indicate
their preference on the form of database providing electronic labels. Public
authorities expressed a general preference either for a centralised EU database
provided by an EU wide authority/provider, but they also responded positively
to electronic labels handled by manufacturers through their websites for their
own products. For industry respondents, on the other hand, the preferred option
would be to have an electronic label directly on their own website in order to
have greater control about the information provided to consumers. However, it
is important to consider that most industry respondents in the study were large
enterprises.
Creation of the online database, particularly the decentralised database, would
be aligned with the aims of the Digital Product Passport (DPP) since, according
to the Sustainable Products Initiative, it will be mandatory for companies to
adopt digital ways of communicating information about products. Hence, under
the adoption of DPP, companies will have to handle additional costs anyway to
comply with this measure and communicate the information about their products
online. Therefore, when calculating the costs for the companies to place their
digital labels online (if the decentralised database approach was selected) it is
important to highlight that development costs would be mandatory under the
DPP and, thus, only the costs of adding the CLP module in their databases should
be taken into account.
Weakly
negative
Public authorities
(Tool #58)
This policy measure would have no impact on public authorities. Neutral
Table 119: Social impact assessment Policy measure 0
Type of
impact
Assessment Score
Consumers
and
households
(Tool #33)
Based on the findings from the survey on the policy measures, the consulted public
authorities in general reported a very positive opinion on the importance of information
currently required on the labels308
(on a scale from -5 to +5 the average response was 4)
apart from ingredients that, despite the wide range of opinions, on average scored only
moderately positive in terms of the safe use of products.
Weakly
negative
308
General product information, Ingredients, Hazard communication (including pictograms and statements),
Precautionary statements, Signal words, Dosage.
398
Type of
impact
Assessment Score
Industry stakeholders (associations and companies) thought that the most important
information in terms of safe use of products are the general product information and the
signal words, followed by the hazard communication information and the precautionary
statements. Dosage information imposed by the Detergents Regulation follows with a
moderately positive score. As above, ingredients scored lowest among industry
stakeholders.
Table 120: To what extent is the current information provided to consumers on labels
able to ensure safe use of the products? (Please consider -5 as the least appropriate ; 0
as neutral and +5 as the most appropriate.)309
Public
authorities
Industry
representatives
General product information310
4 3
Ingredients311
2 -3
Hazard communication (including
pictograms and statements)312
4 2,5
Precautionary statements313
4 2,5
Signal words314
4 3
Dosage (Detergents Regulation)315
4 2
Considering the importance of these pieces of information present in the label, the
consulted stakeholders were asked to assess how problematic current labels can be for
consumers with vision, colour blindness, cognitive/learning and mobility or physical
impairments. According to 58% or respondents of public authorities and 64% of
respondents from industry, current labels are problematic for consumers with vision
impairment316
. 45% of respondents from public authorities and 41% from industry,
report a negative impact on consumers with colour blindness.317
Current labels are
considered also problematic by half of respondents (both public authorities and
industry representative) for consumers with learning/cognitive impairments. More
neutral the opinion for consumers with other impairments.
309
Results provided in the table represent average rating of the piece of information in terms of its importance
to ensure safe use of the products
310
12 responses from public authorities, and 46 responses from the industry representatives.
311
12 responses from public authorities, and 52 responses from the industry representatives.
312
13 responses from public authorities, and 53 responses from the industry representatives.
313
13 responses from public authorities, and 51 responses from the industry representatives.
314
12 responses from public authorities, and 48 responses from the industry representatives.
315
12 responses from public authorities, and 37 responses from the industry representatives.
316
Based on the findings from the online survey on Policy Options. Seven out of 12 respondents belonging to
public authorities, and 30 out of 47 respondents representing the industry.
317
Based on the findings from the online survey on Policy Options. Five out of 11 respondents belonging to
public authorities, and 20 out of 49 respondents representing the industry.
399
Table 121: Environmental impact assessment Policy Measure 0
Type of impact Assessment Score
Sustainable
consumption and
production (Tool
#36)
Concerning environmental aspects, the analysis is limited to awareness of
consumers about the impacts of dispersion of substances in the natural
environment. The analysis does not include an estimate of waste generated by
regulatory changes since legislative revisions include, where relevant, long
enough transition periods during which old labels and packaging can be used to
avoid costs for duty holders and the creation of waste. Under the Baseline Policy
Option, digital labelling would remain voluntary, and no such waste in this case
should not apply anyway.
Based on the findings from the survey, both public authorities and industry
representatives believe that current labels have a positive or very positive impact
on the awareness of consumers about the impact of dispersion of harmful
substances in the natural environment (82% of public authorities, 50% of
industry representative318
).
Weakly
positive
Policy measure 1: Non-legislative measures: Physical labels and guidelines for the
voluntary use of digital label
Overall assessment
There were opposing views among stakeholders on the introduction of industry guidelines
for the use – albeit voluntary – of electronic labels. In general, while consumer organisations
and public authorities see this policy measure positively, this assessment was not shared by
industry representatives.
More specifically, policy measure 1 would entail interventions on the CLP regulation,
summarised in:
 Policy measure: Create a new section/heading under ECHA’s Labelling and
Packaging Guidance with recommendations;
Regarding this policy measure, public authorities, on average, responded positively to the
adaptation of the guidelines (80% gave a positive score), while industry representatives, on
average, saw this intervention slightly negative. Industry representatives argue that this
Policy measure does not address the requirements on the safety use of the physical labels
nor does it incentivise companies to use digital labels (60% of the industry stakeholders).
The views gathered concerning this policy measure by stakeholders is similar to the
preceding policy measure: on average public authorities responded positively to the
adoption of guidelines (89% gave a positive score), while industry representatives expressed
overall a negative appreciation (56% gave a negative score). Overall, industry
representatives provided that this policy measure would not incentivise manufacturers’
adoption of digital tools for those who do not already use them (60% answered negatively).
Table 122: Economic impact assessment Policy measure 1
318
Based on the findings from the online survey on Policy Options. 10 out of 12 respondents from public
authorities, and 25 out of 51 respondents from the industry.
400
Type of impact Assessment Score
Conduct of business
(Tools #21-25)
Compared with PM0, this policy option should have no particular impact for
professional users considering that it would not entail any regulatory change
and the provision of information would still remain on physical labels and
safety data sheets. The cost of conducting business remain the same as per the
baseline scenario.
Weakly
negative
Sectoral
competitiveness,
trade and investment
flows (Tool #21, 27)
This policy option should have no particular impact for the competitiveness of
the industry considering that it would not entail any regulatory change and the
provision of information would still remain on physical labels and safety data
sheets.
Neutral
SMEs (Tool #21) Just as with professional users, PM1 would have no impact on SMEs. The cost
of conducting business remain the same as per the baseline scenario.
Neutral
Technological
development /
Digital economy
(Tool #28)
According to 45% of public authorities, the use of guidelines is considered
strongly positive (on average, the option received a score of 8/10 in terms of
digitalisation).
Industry stakeholders thought that such guidelines would not be very coherent
with the digitalisation trends and assign an average score of 2/10.
Neutral
Public authorities
(Tool #58)
In this specific policy option, considering that the intervention would mean
updating the ECHA guidance for CLP and the FAQ for detergents, no specific
enforcement costs for public authorities were considered.
Public authorities and industry associations indicated that updating guidelines
carries relatively low costs. None of the participating stakeholders indicated a
high cost for the development of such guidelines.
Neutral
401
Table 123: Social impact assessment Policy measure 1
Type of
impact
Assessment Score
Consumers
and
households
(Tool #33)
The update of guidelines – according to public authorities - would have a marginal, yet
positive, impact on consumer awareness. Indeed, public authorities responding to the
survey thought that the introduction of guidelines might have a positive impact in terms of
increased safety for consumers, awareness and consumer choice.
However, for more than half of industry respondents, the use of guidelines would have no
impact on consumer safety.
Regarding the impact on vulnerable consumers, for a third of public authorities and half of
industry representatives, PM1 would have no impact on this group with slightly positive
effects, according to public authorities, for consumers with visual and cognitive/learning
impairments. Only a third of industry participants to the survey consider PM1 as potentially
having a positive impact on consumers with visual impairments, colour-blind and with
cognitive/learning difficulties.
The analysis included also the assessment of potential alternative solutions. In general,
consulted stakeholders from industry reported an overall preference for the availability in
store of information on products (either digitally or physically). This option is considered
the most feasible by stakeholder but also the most costly. The most cost-effective solution
would be a dedicated telephone line providing the required product information, while the
least cost-effective solution being the use of SMS with product information.
Figure 82: Stakeholders assessment of backup solutions (responses from the industry
and public authorities)
Weakly
positive
0,0
2,0
4,0
Feasibility Cost Effectiveness Overall assessment
Responses from industry
Product information available digitally or physically in store
SMS with product information
Dedicated telephone line providing product information
Dedicated smartphone application
0,0
2,0
4,0
6,0
Feasibility Cost Effectiveness Overall assessment
Responses from the public authorities
Product information available digitally or physically in store
SMS with product information
Dedicated telephone line providing product information
Dedicated smartphone application
402
Table 124: Environmental impact assessment Policy measure 1
Type of impact Assessment Score
Sustainable
consumption and
production (Tool
#36)
Regarding the impact of PM1 on consumer awareness about the impact of
dispersion of harmful substances in the natural environment, the survey shows
that both public authorities and industry representatives consider this policy
option as relatively neutral. Half of participating public authorities believe the
guidelines might have a minor positive effect, while 84% of industry respondents
consider PM1 as potentially having a neutral or slightly positive effect.
Neutral
Policy measure 2: Revision of the labelling rules in the regulations: align the two
regulations and address inconsistencies in the Detergents Regulation on the physical
label only
Overall assessment
The consulted stakeholders had an overall positive view about the alignment of the two
regulations and the revision of the Detergents Regulation to address inconsistencies,
overlaps and duplications on the physical label. All of the stakeholders representing public
authorities (11) assessed policy measure 2 as positive with eight out of 11 stakeholders
assessing the policy measure as very positive and rating the assessment of the policy
measure as 4 or 5 out of 5. On the other hand, industry representatives had a slightly less
positive opinion on the policy measure, with 62% of these stakeholders (16 out of 26)
assessed policy measure 2 as positive.
The legal intervention foreseen under Policy measure 2 to streamline the labelling
requirements between the CLP Regulation and the Detergents Regulation between the two
regulations was agreed by all categories of stakeholders during the interviews, especially by
industry representatives who insisted on the benefits of this intervention to remove
duplications of information on chemical labels and thus create more space for other
information to be conveyed in a more readable manner.
First, labelling requirements under the Detergents Regulation would need to be streamlined
to avoid overlaps, inconsistencies and duplications with the CLP Regulation. In addition,
policy measure 2 aims to simplify and clarify the rules on labelling of allergenic fragrance
ingredients in a way that the same fragrance ingredient falling within the scope of both
Regulations is not labelled twice or thrice on the same label. This simplification should also
consider the existing differences between the two Regulations in the identification of a
substance, i.e., the name (and identification number) under which the sensitising fragrance
is to be labelled.
For this purpose, this policy measure is declined under two sub-options, as follows:
 Sub-measure 2a: the Detergents Regulations provides that the remaining
overlapping provisions are to be labelled only once, either following the CLP or
Detergents Regulation, based on the stricter rules;
 Sub-measure 2b: all overlapping provisions are removed from the Detergents
Regulation.
403
Regarding the assessment of these two sub-options in the survey, it must be noted that public
authorities and consumer organisations had no particular preference on either of these sub-
options, while industry representatives expressed a slight preference for sub-measure 2b
arguing that sub-measure 2b would be more straightforward to apply for industry. However,
it must be noted that removing the overlaps between the two regulations would also mean
that the thresholds for labelling some allergenic fragrances would be higher, thus indicating
a potential concern that consumers might be less informed about the presence of these
substances in detergents.
In addition, one of the findings from the Open Public Consultation was that stakeholders, in
general, believe that the most effective method to increase the communication of
information on labels of chemicals is by simplifying the text on labels319
, while, on the other
hand, one of the least effective ways to increase the communication, according to the
respondents, was having more detailed information provided on the on-pack label (e.g. more
detailed use instructions, etc.)320
. Moreover, the most popular response to the question on
how the information on detergents label could be simplified was “Avoiding that the same
ingredient is listed multiple times on the label”321
, which stresses the importance of
simplifying physical labels and avoiding the duplications due to overlaps between the CLP
and Detergent Regulations.
Provides information about the impact of Policy measure 2. However, as outlined above,
these impacts will occur due to changes in the Detergents Regulation, not due to changes in
CLP. The impacts are, therefore, not considered for this impact assessment and provided
here only for information. The changes in the Detergents Regulation will address the issues
identified in the chemicals Fitness Check.
319
Most popular option among the stakeholders with 24% of the votes (160 out of 675 total votes)
320
Third least popular option among the stakeholders with 3% of the votes (19 out of 675 total votes)
321
Most popular option among the stakeholders with 22% if the votes (113 out of 522 total votes)
404
Table 125: Economic impact assessment Policy measure 2
Type of impact Assessment Score
Conduct of business
(Tools #21-25)
Based on the findings from the survey on the policy options, around 80% of the
consulted stakeholders from public authorities think that addressing the
inconsistencies, overlaps and duplications on the physical label would have a
positive impact on professional users in terms of label readability, and overall
safety of products dedicated to professional and industrial users. On the other
hand, only around half of the industry stakeholders believe that this policy
measure would bring positive impact to professional users concerning these
aspects.
Concerning the costs, according to the large majority (around 80%) of consulted
industry stakeholders, the costs or benefits of the revisions under policy measure
2 would generate none to very low impact on enterprises. More specifically,
around 50% of industry stakeholders believe that the clarifications under policy
measure 2 would not generate relevant costs for companies, and 31% consider
that such revisions would generate low costs. Consulted stakeholders from the
companies that sell detergents argue that the costs associated with policy
measure 2 would be one-off cost related to the disposal of the non-compliant
labels, however, companies would not face any recurring annual costs after this
has been done. These costs, although low in scale, would vary greatly depending
on the size of the production and the timeline designated for the implementation
of the regulatory changes.
In terms of benefits, only 20% of industry respondents consider the revisions
under policy measure 2 to provide economic benefits to businesses arguing that
although the communication of the safe use of the product would increase under
the policy measure, all impacted product physical labels would still need to be
updated to comply with the new regulation, therefore, increasing costs even if
low. In the long term, however, industry stakeholders see the possibility of less
re-labelling in the future due to new fragrances falling under CLP Sub
measure 2b. This way, there is a potential for less re-labelling and recreation of
labels for skin sensitisers (i.e. sensitising) substances like preservatives and
fragrances as fewer of these substances would need to be labelled.
Neutral
Sectoral
competitiveness,
trade and investment
flows (Tool #21, 27)
Large part of consulted stakeholders could not provide an opinion on the
expected impact of policy measure 2 on competitiveness. Amongst respondents,
according to 45% of consulted public authorities, policy measure 2 would not
have an effect on competitiveness of European companies. 26% of industry
representatives also consider that policy measure 2 would not have an impact on
competitiveness of enterprises, while 10% of respondents consider the
possibility that policy measure 2 would have a negative impact. In conclusion,
consulted stakeholders generally estimate that the impact of policy measure 2 on
competitiveness would be minimal and negligible.
Neutral
SMEs (Tool #21) According to consulted stakeholders, the majority (both public authorities and
industry representatives) consider that the provisions under policy measure 2
would not impact SMEs disproportionately in comparison to larger enterprises.
Neutral
Technological
development /
Digital economy
(Tool #28)
Policy measure 2 is a regulatory alignment of the Detergents Regulation and it
does not include the use of digital labels. Therefore, there is no information on
the alignment with digitalisation trend.
Neutral
Public authorities
(Tool #58)
The majority of consulted stakeholders (82%) estimate that the provisions of
policy measure 2 would not generate costs – or very low costs – for public
authorities. On the other hand, nearly half (45%) of consulted public authorities
reported that policy measure 2 would generate a benefit thanks to the
simplification and streamlining of the regulatory framework. Representatives
from the public authorities argue that changes under policy measure 2 would not
require extra surveillance from them, yet, aligning the regulations and
inconsistencies could make it more simple for end users and consumers to read
and understand the label of certain products, which would in turn simplify the
guidance of national authorities.
Strongly
positive
405
Table 126: Social impact assessment Policy measure 2
Type of impact Assessment Score
Consumers and
households (Tool
#33)
In terms of the impact of the proposed policy measure 2 on the awareness of
consumers, addressing inconsistencies, overlaps and duplications on the
physical label – according to both public authorities and industry representatives
– would have an overall positive impact on consumers.
More specifically, label readability would be improved according to a large
majority of public authorities (90%, 11 out of 12) and of industry representatives
(85%, 22 out of 26).
Weakly
positive
Table 127: Environmental impact assessment Policy measure 2
Type of impact Assessment Score
Sustainable
consumption and
production (Tool
#36)
Based on the survey findings, the majority of public authorities (55%) answered
that addressing the inconsistencies overlaps and duplications on the physical
label would bring a positive impact to the awareness of consumers on the effects
of dispersion of harmful substances in the natural environment. However, a
majority of the industry representatives (over 80%) think that this Policy Option
would not bring any positive impact to the environment. Stakeholders from
industry claim that current overlaps between CLP and Detergents Regulation do
not specifically consider environmentally hazardous substances.
Neutral
Policy measure 3: Revision of the labelling rules in the regulations, introducing
optional digital labelling: keep basic information of labelling requirements on physical
labels, and move certain labelling requirements on the digital label only.
Overall assessment
According to consulted stakeholders, the average assessment of Policy measure 3 for both
public authorities and business representatives is positive. Public authorities have, on
average, a more positive view with half of respondents reporting a very high score for Policy
measure 3. Industry representatives, on average, also reported an overall positive position
with more than 80% of participants in the survey assessing the policy option positively.
More specifically, policy measure 3 entails specific provisions affecting CLP (e.g. the
possibility to provide overlapping information between precautionary statements and hazard
statements and supplemental labelling information online), and the proposal of principles
of application of digital labels. During interviews, stakeholders from all categories agreed
that hazard information (encompassing notably the hazard statements) was one of the most
useful information to be conveyed to consumers. However, they also noted that in some
cases there could be an overlap or a redundancy of information given between the hazard
statements and the precautionary statements, and that this redundancy could be addressed
to simplify and optimise space on the label. This findings was confirmed by the feedback
collected in the survey where, according to public authorities, this intervention on the CLP
Regulation under Policy Measure 3, is considered positively by 73% of participants. A large
majority of industry representatives (82%) also confirmed this positive assessment.
However, the study did not identify any noteworthy overlap.
In the survey, consulted stakeholders were also asked to provide an assessment of the
proposed principles for the use of digital labels. The overall feedback is that all the proposed
406
principles are highly relevant. As shown in the chart below, the principles with the highest
agreement are:
1. Accessibility of data in terms of ease of access (i.e. “two-click” maximum rule to
access the information) and accessibility for users with disabilities;
2. Technological neutrality of IT solutions (i.e. minimum technical requirements to be
complied with in order to ensure technological neutrality); and
3. Protection of personal data.
Figure 83: Feedback of consulted stakeholders on digital labelling principles322
Source: Online survey on the policy options.
Stakeholders had mixed opinions regarding the obligation to provide all data in one place
and on the format to be used for the provision of digital data (i.e. font size) with around 20%
of industry respondents expressing a negative view on the mentioned principles. However,
overall also for this principle there was overall support.
Some industry representatives also expressed a negative view about a centralised EU
database for providing information digitally. Such a database would force companies to
adopt a digital solution, the structure of which would be managed externally. Since
companies work differently, it could take a long time to establish such a centralised
database.
322
Protection of personal data of consumers accessing e-labels: PA = 9, industry = 35 ; Accessibility of the
data both in terms of ease of access and in terms of accessibility for users with disabilities: PA = 10, industry
= 34; Technological neutrality of IT solutions: PA = 8, industry = 35; The obligation to provide all data in
one place: PA = 12, industry = 33; A ban on mixing mandatory information with marketing information: PA
= 13, industry = 34; The format of the data provided digitally (i.e. font size): PA = 12, industry = 35;
Alternative ways of providing information: PA = 11, industry = 31.
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
PA Industry PA Industry PA Industry PA Industry PA Industry PA Industry PA Industry
Protection of
personal data of
consumers accessing
e-labels
Accessibility of the
data both in terms of
ease of access and in
terms of accessibility
for users with
disabilities
Technological
neutrality of IT
solutions
The obligation to
provide all data in
one place
A ban on mixing
mandatory
information with
marketing
information
The format of the
data provided
digitally (i.e. font
size)
Alternative ways of
providing
information
Very low Low Neutral High Very high
407
Furthermore, based on the findings from the Open Public Consultation, the majority of the
consulted stakeholders323
think that, in the context of detergents, fertilising products, and
other chemical products, removing some of the information from the on-pack label to the
digital labels would have a moderately positive or a very positive effect overall.
Figure 84: In the context of the below chemical products, how would you evaluate it if some information was
removed from the on-pack label and could only be obtained via digital labels?
Source: Open Public Consultation. Respondents: N = 153 for Fertilising Product, N= 165 for Detergents, and N = 180
for other chemicals.
However, citizens and consumer organisations had mixed views on moving the information
from physical to digital labels as around half of the stakeholders representing consumers
supported the process of moving the information, while the other half opposed this action.324
In terms of the benefits associated with digital labelling, the majority of the respondents
rated all the listed benefits325
as moderately beneficial or extremely beneficial with “Better
management of fast changing label information” considered most beneficial326
, and “cost
savings” as least beneficial”.327
323
125 out of 180 respondents who have answered to a part on the other chemical products such as glues, lamp
oils, paints, solvents, etc., 112 out of 165 respondents who have answered to a part on the detergents, and 103
out of 153 respondents who have answered to a part on the fertilising products.
324
For ‘other chemicals’, 25 out of 52 respondents expressed a very negatively or a moderately negatively
impact, and 24 out of 52 expressed a moderately positively or very positively impact. For detergents, 21 out
of 49 respondents expressed a very negatively or a moderately negatively impact, and 22 out of 48 expressed
a moderately positively or very positively impact. For fertilising products, 23 out of 47 respondents expressed
a very negatively or a moderately negatively impact, and 18 out of 47 expressed a moderately positively or
very positively impact.
325
The listed benefits included: “Better management of fast changing label information”, increased ease of
complying with labelling requirements”, better targeted communication” and “cost savings”.
326
111 out of 124 respondents (90%) have selected options “Extremely beneficial” or “Moderately beneficial”.
327
65 out of 117 respondents (56%) have selected options “Extremely beneficial” or “Moderately beneficial”.
12%
13%
12%
12%
10%
10%
21%
26%
27%
46%
42%
43%
0% 25% 50% 75% 100%
Fertilising Products
Detergents
Other chemical products such as glues, lamp
oils, paints, solvents, etc.
Very negatively Moderately negatively
Neither positively nor negatively Moderately positively
Very positively Other
408
Concerning challenges, around half of respondents assessed “Increased costs associated
with training”328
and “Increased costs associated with changes to design /packaging”329
as
little challenging or not challenging at all, while around half of the respondents rated the
“Implementing IT solutions”330
as moderately or extremely challenging. Overall, only a
minority of respondents considered the introduction of digital labelling as extremely
challenging.
Table 128: Economic impact assessment Policy measure 3
Type of impact Assessment Score
Conduct of business
(Tools #21-25)
Regarding the possible impacts of policy measure 3 measures on professional
users, the opinion of consulted stakeholders changes marginally in comparison
to the assessment for consumers.
More specifically, the survey finds that around 60% of PA respondents consider
the possibility to provide on digital labels only overlapping information on p-
statements (Art. 22 CLP) with H-statements (Art.21 CLP) as positive for
professional user safety (30% estimate a negative impact). A large share of
industry representatives reported a neutral position on this measure (39% of
industry respondents) and 57% indicated a positive impact on safe use of
professional users. In addition, 71% of professional users view the possibility of
using online electronic labels for chemical products positively.
Overall, stakeholders expect a generally positive impact of PO3 CLP
measures.
In terms of costs, industry stakeholders generally (66%) believe costs for
individual manufacturers to comply with policy measure 3 would be slightly
higher than the benefits (59%) and this holds true for both the revisions in CLP
and Detergents Regulations.
Although it is difficult to estimate the costs of introducing a digital label and
moving some of the information online, stakeholders from the industry
explained that it would take around three to four FTEs who would need 10 to
20 working days to conduct familiarisation activities (e.g. training,
consulting) at the company level. It is important to highlight though that under
policy measure 3, businesses would have to decide themselves if they want to
turn to digital labelling as it would be done on a voluntary basis.
In regards to other costs that are related to the compliance with the regulatory
changes (implementation of IT solutions, maintaining website for the e-labels,
managing different data formats, costs associated with changes to
design/packaging, etc.), currently, manufacturers are already providing a digital
version of their products information, either on the digital versions of the SDS
or for the information obligations towards the poison centres. In addition, market
data show that a large majority of businesses already have an online website
which could host such information. In addition, once set up and automated
maintenance costs would be expected to be minimal. Thus, even if the potential
operational costs and benefits under policy measure 3 could not be monetised,
the overall assessment suggests that the costs would be negligible or low.
In addition, market practices suggest that, in most cases, enterprises out-source
and use third-party software for the management of information on labels.
Therefore, third-party software would be likely to financially benefit from this
policy measure.
In terms of the benefits of the revisions under policy measure 3, industry
stakeholders consider the possibility to reduce the frequency of changes in
physical labels, and better management of fast changing label information. These
potential benefits, however, could not be estimated quantitatively due to the wide
Weakly
positive
328
61 out of 122 total responses (50%).
329
66 out of 128 total responses (52%).
330
63 out of 127 total responses (49.5%).
409
Type of impact Assessment Score
range of variables affecting labels (e.g. size of the label, number of ingredients,
type of chemical product, etc.).
Sectoral
competitiveness,
trade and investment
flows (Tool #21, 27)
A large share of stakeholders could not provide an opinion on the expected
impact of policy measure 3 on competitiveness (72% of public authorities, 71%
of industry representative).
Amongst respondents, according to 27% of consulted public authorities, policy
measure 3 would have a positive effect on competitiveness of European
companies. 17% of industry representatives believed policy measure 3 would
have a positive effect on competitiveness of EU enterprises while 12% of
respondents believe that these measures would have a negative impact.
Neutral
SMEs (Tool #21) Regarding the impact of policy measure 3 on SMEs, a large share of respondents
could not provide an answer. According to most industry representatives (65%),
the introduction of digital labels would not have a disproportionate impact on
SMEs in comparison to large enterprises. However , amongst public authorities,
the number of those expecting higher costs for SMEs is higher than those that
would expect no difference.
Neutral
Technological
development /
Digital economy
(Tool #28)
In general, the opinion of consulted stakeholder about the coherence of policy
measure 3 with market digitalisation trends is particularly high for both PA
respondents (6,5/10 score) and industry representatives (7/10 score).
Industry respondents were also asked if, under policy measure 3, they would see
an incentive for businesses to use digital labels. There was a positive response
from 75% of respondents.
Strongly
positive
Public authorities
(Tool #58)
According to the majority of consulted stakeholders (75%), the provisions of
policy measure 3 would not generate costs – or very low costs – for public
authorities. Nonetheless, only around one-third (30%) of consulted public
authorities reported that policy measure 3 would generate a benefit for
monitoring activities of Market Surveillance Authorities. Hence, impact to
public authorities is negligible.
Neutral
410
Table 129: Social impact assessment Policy measure 3
Type of impact Assessment Score
Consumers and
households (Tool
#33)
Concerning the provision of supplemental labelling information on digital labels,
the opinion of a large majority of stakeholders is positive: 78% of PA and 83%
of industry representatives.
The use of digital labels could have a negative impact on the well-being of
groups of population without access to these digital tools (e.g. smartphone,
internet access or other technical difficulties). According to consulted
stakeholders, the majority (54%) of consulted public administrations and
industry representatives considered this an important drawback to be taken into
account. However, for those population groups the physical label with all critical
information on it would remain available as today.
The use of digital labels for the provision of product information is considered,
by a majority of the consulted stakeholders, a solution that could improve the
well-being of consumers with visual impairments. According to 70% of PA
respondents and 64% of industry representatives, the impact on this group of
consumers could be positive.
According to stakeholders, the effect of electronic labels could be positive also
for people affected by colour-blindness (40% of PA respondents and 57% of
industry representatives). More neutral is the position of the majority of
respondents regarding the potential impact of policy measure 3 and the use of
digital labels on the well-being of consumers with other types of impairments
(cognitive/learning and physical/mobility disabilities or others).
Strongly
positive
Table 130: Environmental impact assessment Policy measure 3
Type of impact Assessment Score
Sustainable
consumption and
production (Tool
#36)
Regarding the potential effects of policy measure 3 on consumer awareness
about the impact of dispersion of harmful substances in the natural environment,
half (50%) of PA respondents would expect a partially positive impact, while
30% had a neutral view. Similar views were expressed by industry respondents,
where 61% would expect a positive impact and 35% had a neutral position.
Weakly
positive
Policy measure 4: Revision of the labelling rules in the regulations, introducing digital
labelling: further simplification of physical labels, and move additional information
on the digital label
Overall assessment
The overall assessment of policy measure 4 is mixed and varies considerably between public
authorities and industry representatives. While for public authorities the possibility for
manufacturers to provide additional mandatory information exclusively on e-labels would
have a quite negative impact, the average feedback from industry representatives is very
positive.
According to participating public authorities, the assessment of the intervention under
Policy measure 4 on the CLP Regulation is negative while a positive average assessment is
reported by industry representatives. During interviews, stakeholders from all categories
agreed that hazard information (encompassing notably the hazard statements) was one of
the most useful information to be conveyed to consumers. In addition, communicating
information on the safe and appropriate use of products to consumers – notably through
precautionary statements – was also agreed by all stakeholders to be the most important type
of information to be communicated on chemical labels. Therefore, findings from the
411
interviews rather point to the fact that stakeholders from all categories would asses
negatively the possibility to provide this information exclusively on a digital label.
Furthermore, it must be noted that, according to the findings of the behavioural experiment,
for both products tested (glues and detergents), the hazard and precautionary statements on
the label were the most relevant reason for rating the product as dangerous (69% for both
product types) for consumers, which suggests that they are indeed most useful for
consumers to be provided on pack.
Table 131: Economic impact assessment Policy measure 4
Type of impact Assessment Score
Conduct of business
(Tools #21-25)
The opinion of stakeholders regarding the impact on professional users is similar
to the views provided in general for consumers. Based on the survey findings, a
majority of public authorities see the impact on professional users negatively
while industry representatives see the provisions under PO4 as potentially
positive. In fact, 71% of the professional and industry users view the possibility
of using the online electronic labels for chemical products positively. More
specifically, concerning the P-statements (Art. 22 CLP) and H-statements
(Art.21 CLP), around 70% of the professional and industry users think that
moving these pieces of information from physical to digital label would have no
detrimental effects to workers’ safety. Therefore, the opinion on the impact of
PO 4 to the professional users has been marginalised across different categories
of stakeholders as consumers and public authorities view the provisions under
PO4 as negative.
Concerning the costs, according to the large majority of consulted industry
stakeholders, the proposed measures under PO4 would generate a high cost for
companies (68%) which would however be compensated by larger benefits
(79%).
The costs for the implementation of a digital solution for individual companies
under Policy measure 4 do not differ from the calculations made under Policy
measure 3. Thus, the same type of costs should be considered for the assessment
of this policy option. Nevertheless, the share of companies that would transfer
some of the information from physical to digital labels would be larger as using
digital labels would no longer be voluntary but mandatory.
Thus, as under Policy Measure 3, industry stakeholders explained that it would
take around three to four FTEs who would need 10 to 20 working days to
conduct familiarisation activities (e.g. training, consulting) at the company
level. In regards to other costs that are related to the compliance with the
regulatory changes (implementation of IT solutions, maintaining website for the
digital labels, managing different data formats, costs associated with changes to
design/packaging, etc.), even if the potential operational costs and benefits under
PO 4 could not be monetised, the overall assessment would suggest that size of
the costs would be negligible or low.
In regards to the benefits, according to consulted stakeholders, in addition to
already mentioned benefits under Policy measure 3 (reducing the frequency of
changes in physical labels, and better management of fast changing label
information) Policy measure 4 would increase the share of information provided
only on digital labels which would allow for more space on physical labels for
multiple languages. This would allow for more cost-effective product
distribution across EU markets and thus a larger benefit under Policy measure 4
than under Policy measure 3. These potential benefits, however, could not be
estimated in monetary terms due to the wide range of variables affecting labels
(e.g. size of the label, number of ingredients, type of chemical product, etc.).
Weakly
positive
Sectoral
competitiveness,
trade and investment
flows (Tool #21, 27)
A large share of stakeholders could not provide an opinion on the expected
impact of Policy measure 4 on competitiveness.
There is no clear position of industry representatives on the effect on
competitiveness of Policy measure 4 with half of respondents estimating a
positive effect and another half estimating a negative effect. The position of
Neutral
412
Type of impact Assessment Score
public authorities is clearer with 67% estimating a positive effect on
competitiveness of EU enterprises under Policy measure 4.
SMEs (Tool #21) Regarding the impact of Policy measure 4 on SMEs, the opinion of consulted
stakeholders is similar to Policy measure 3. Most public authorities would expect
a disproportionate impact on costs for SMEs in comparison to larger enterprises
because larger companies have more resources to successfully implement digital
labels and, thus, have an advantage in providing information and marketing
through digital labels when compared to SMEs.
For industry representatives, no clear position is expressed, with half of
respondents estimating disproportionate costs for SMEs and the other half
estimating that there would be no difference between SMEs and larger
companies.
Weakly
negative
Technological
development /
Digital economy
(Tool #28)
Both public authorities and industry representatives agree that Policy measure 4
is in line with digitalisation trends. While for public authorities the assessment
of Policy measure 4 in terms of digitalisation is not higher than PO3, for industry
representatives Policy measure 4 measures represent a higher level of alignment
to digitalisation trends.
Strongly
positive
Public authorities
(Tool #58)
According to around one-fourth of the public industry stakeholders (23%), the
provisions of Policy measure 4 would generate high or very high costs for public
authorities. Nonetheless, only 9% of consulted public authorities reported that
Policy measure 4 would generate a benefit for the monitoring activities of MSAs.
According to the consulted public authorities, the benefits for public authorities
would concentrate on the simplification and clarification of labelling
requirements which would make the monitoring and the inspection process for
the public authorities and the compliance process for the businesses equally
easier. The benefit, however, is considered to be minimal even though the costs
are not considered to be very high as well.
Strongly
negative
413
Table 132: Social impact assessment Policy Measure 4
Type of impact Assessment Score
Consumers and
households (Tool
#33)
In general, policy measure 4 is considered as potentially negative or very
negative according to 70% of participating public authorities. In contrast
industry stakeholders estimate the expected impact on consumer safety as
strongly positive (78%). Overall, stakeholders from the public authorities331
and
industry332
both expressed support for the proposed interventions on the
Detergents Regulation rather than the CLP regulation under Policy Measure 4.
Moreover, respondents were asked to provide an individual assessment of the
potential impact of CLP measures on consumer safety. The possibility of
allowing H-statements and P-statements exclusively on digital labels is
considered negatively by a large majority of public authorities: 78% against H-
statements on digital labels and 64% against P-statements on digital labels. The
position of public authorities on the possibility of providing supplemental
labelling information on digital labels is mixed with only a third of respondents
having a negative view on this possibility.
The view of industry stakeholders is largely in favour of the CLP revisions under
Policy measure 4. 73% of respondents are in favour of placing H-statements on
digital labels, 70% in favour of P-statements on digital labels and 77% in favour
of supplemental information on digital labels. In general, around a fifth of the
consulted industry representatives see the possibility of having H and P
statements exclusively on digital labels as being potentially negative for
consumer’ safety.
Similarly to Policy measure 3, the opinion of all the consulted stakeholders is
that the possibility of having digital labels would have a positive impact on
consumers with visual impairments (50% approval rate from the public
authorities and 76% approval rate from the industry representatives).
Weakly
negative
Table 133: Environmental impact assessment Policy measure 4
Type of impact Assessment Score
Sustainable
consumption and
production (Tool
#36)
According to 60% of the consulted public authorities, the provisions under
Policy measure 4 would have a negative impact on the disposal of harmful
substances in the environment arguing that the awareness impact of the
consumer is dependent on end-user knowledge of the changes and where to
find information, and consumers are not trained to understand all the chemical
information and they do not have the same awareness as professional users.
Industry stakeholders had the opposite view with 64% of respondents (18 out
of 28) considering Policy measure 4 having a positive impact on consumer
awareness on disposal of harmful substances.
Neutral
331
Five out of nine stakeholders from public authorities viewed the interventions on the Detergents Regulation
as positive, while only three out of nine stakeholders from the public authorities viewed the interventions on
the CLP as positive.
332
15 out of 18 stakeholders from the industry viewed the interventions on the Detergents Regulation as
positive, while 24 out of 31 stakeholders from the industry viewed the interventions on the CLP as positive.
414
Policy measure 5: Revision of the labelling rules in the regulations, introducing
optional digital labelling: in specific cases, providing all information on the digital
label
Overall assessment
Concerning Policy measure 5, stakeholders were consulted on the possibility for
manufacturers of providing mandatory information exclusively on electronic labels in
specific cases and/or specific products. This concerns
products which are sold to consumers in bulk (i.e. without a container), such as fuels at
filling stations
products for which the label or packaging is too small to physically include any or all
mandatory information, such as writing instruments (e.g. pens, highlighters).
It must be noted that this concerns product which are already subject to labelling today. The
fact that they are currently often not labelled due to practicalities associated with the
labelling constitutes a non-compliance. Costs associated with Policy measure 5 are part of
the baseline. They are assessed as policy option due to stakeholder interventions.
Overall, based on the findings from the online survey on the Policy measures, public
authorities had a slightly positive opinion on Policy measure 5 and its proposed
interventions on the CLP Regulation and on the Detergents Regulation333
. Similarly,
industry stakeholders also expressed a positive opinion on Policy measure 5 (83% assessed
Policy measure 5 positively334
), preferring the interventions proposed on the CLP
Regulation335
to the interventions proposed on the Detergents Regulation336
.
Table 134: Economic impact assessment Policy measure 5
Type of impact Assessment Score
Conduct of business
(Tools #21-25)
Policy measure 5 does not consider the impact the policy measures of Policy
measure 5 would have on the professional users.
In terms of costs and benefits, around a third of consulted stakeholders consider
that policy measure 5 measures would generate benefits that exceed the costs
of the option. In particular due to the interventions under the CLP, a majority of
respondents (78%) believed that the policy option would bring benefits and less
than half (43%) think that compliance with the regulatory changes under policy
measure 5 would carry costs for them.
Costs for implementation of a digital solution for individual companies under
policy measure 5 do not differentiate from the calculations made under policy
measure 3 or policy measure 4. Thus, same type of costs should be considered
for the assessment of this policy measure. Nevertheless, the share of companies
that would transfer some of the information from physical to digital labels would
be larger compared to policy measure 3 as using digital labels would no longer
be voluntary but mandatory. In addition, the share of information that would
Strongly
positive
333
Six out of 10 stakeholders from the public authorities have assessed PO 5 as positive, seven out of nine
stakeholders have assessed the proposed interventions on the CLP Regulation under Policy Option 5 as
positive, and five out of nine stakeholders have assessed the proposed interventions on the Detergents
Regulation under Policy Option 5 as positive.
334
25 out of 30.
335
21 out of 26 (81%)
336
Nine out of 14 (64%)
415
Type of impact Assessment Score
have to be placed on the digital labels would also increase compared to policy
measure 4, therefore, costs337
and benefits stemming from policy measure 5
should be higher than the ones from policy measure 4.
Although it is difficult to estimate the costs of introducing digital labels and
moving information on specific products online in monetary terms, stakeholders
from the industry explained that it would take around three to four FTEs who
would need 10 to 20 working days to conduct familiarisation activities (e.g.
training, consulting) at the company level.
For other costs that are related to the compliance with the regulatory changes
(implementation of IT solutions, maintaining website for the e-labels, managing
different data formats, costs associated with changes to design/packaging, etc.),
even if the potential operational costs and benefits under policy measure 5 could
not be monetised, the overall assessment would suggest that size of the costs
would be negligible or low.
For the benefits, according to consulted stakeholders, in addition to already
mentioned benefits under policy measure 3 and 4 (reducing the frequency of
changes in physical labels, better management of fast changing label
information, improving the possibility of increasing the amount of information
only on electronic labels) policy measure 5 would allow better understanding of
the hazard classification, and an improved and faster way of communicating
changes in hazard classification. These potential benefits, however, could not be
estimated quantitatively due to the wide range of variables affecting labels (e.g.
size of the label, number of ingredients, type of chemical product, etc.).
Sectoral
competitiveness,
trade and investment
flows (Tool #21, 27)
A large share of consulted stakeholders (both public authorities and industry
representatives) believe that the measures under policy measure 5 would not
have competitiveness impacts.
Neutral
SMEs (Tool #21) Regarding the impact of policy measure 5 on SMEs, the opinion of consulted
stakeholders diverges considerably between public authorities and industry
representatives. While the large majority of PAconsider policy measure 5 having
a disproportionate effect on SMEs in comparison to larger companies, less than
a third of industry representatives share a similar view (thought it should be
noted that the majority of industry respondents were from larger companies).
Neutral
Technological
development /
Digital economy
(Tool #28)
Similarly to other policy measure that include the use of digital labels, according
to the majority of public authorities and industry, policy measure 5 would have
a positive impact on coherence with digitalisation.
Strongly
positive
Public authorities
(Tool #58)
Considerably small group of consulted public authorities (three out of 12, or
25%), estimate the provisions of policy measure 4 would generate high or very
high costs – for public authorities. Nonetheless, only one stakeholders reported
that policy measure 5 would generate a benefit for the monitoring activities of
MSAs. According to the consulted public authorities, the benefits for the public
authorities would concentrate on the simplification and clarification of the
labelling requirements which would make the monitoring and the inspection
process for the public authorities and the compliance process for the businesses
equally easier. The benefit, however, is considered to be minimal even though
the costs are not considered to be very high as well.
Strongly
negative
337
Operational costs, although at the low level, should increase, however, costs related to the familiarisation
activities should remain the same.
416
Table 135: Social impact assessment Policy measure 5
Type of impact Assessment Score
Consumers and
households (Tool
#33)
The possibility for manufacturers to provide mandatory information on
electronic labels in specific cases and/or specific products would fill a current
information gap (since this information is currently not provided on physical
labels for these products). Industry representatives (around 70%) believe that
this policy option would have a positive impact on general consumer safety.
The majority of industry stakeholders (around 60%) and 40% of stakeholders
from public authorities think that Policy measure 5 would have a positive impact
on visually impaired consumers because communication on digital labels can
transfer all the relevant information online in an easily readable way rather than
have all this information in small letters in a very limited space on a can, tin or
a tube.
Weakly
positive
Table 136: Environmental impact assessment Policy measure 5
Type of impact Assessment Score
Sustainable
consumption and
production (Tool
#36)
According to the majority of the public authorities (55%), this measure would
have a negative impact on the awareness of consumers on the effects of
dispersion of harmful substances in the natural environment. Around half of
industry representatives think that this policy measure would have no impact on
the environment.
Weakly
negative
COMPARISON OF IMPACTS AND PREFERRED OPTION
Overall comparison of the assessment criteria
The analysis in the previous chapter allows for an overall comparison of the proposed policy
measures for digital labelling. The following tables summarise the assessments of the policy
measures described in the previous section. Each impact is colour-coded as shown in Table
136. Description of the analytical methods used in preparing the impact assessment
measures together with the robustness and limitations of the analysis presented in this
chapter is available in Annex 13e.
Effectiveness
To assess the effectiveness of each Policy Measure, firstly, we need to assess them vis-à-
vis two specific objectives of digital labelling, namely:
SO1: improve consumer understanding and awareness of labels, by simplifying and
streamlining the existing labelling requirements in the Detergents regulation.
SO2: set up a future proof regulatory framework allowing the use of digital tools to
communicate product information.
Note: The impacts under SO1 will be incurred by the Detergents regulation, not by CLP.
The impacts are presented here for information only and for transparency reasons.
417
Table 137: Assessment of the Policy measures vis-à-vis the specific of objectives of the study
Specific
objective
Policy
measure 0
(baseline)
Policy
measure 1
Policy
measure 2
Policy
measure 3
Policy
measure 4
Policy
measure 5
SO 1 No or
limited
impact
No or
limited
impact
Weakly
positive
Strongly
positive
Strongly
negative
Weakly
positive
SO 2 No or
limited
impact
No or
limited
impact
No or
limited
impact
Strongly
positive
Strongly
positive
Strongly
positive
Based on the findings from the survey, public authorities and industry representatives have
expressed a very positive opinion on the impact policy measure 3 would have on the overall
consumer and end-user label readability, and safe use of the products for consumer in
comparison to the current situation. According to the consulted stakeholders, Policy
measures 2 and 5 would have a slightly positive and Policy measures 0 and 1 would have
limited or no impact on the readability and safe-use of the products. Considering Policy
measure 4, stakeholders mentioned that this policy measure would entail the possibility for
manufacturers to provide H and P statements on online labels. This possibility is considered
by public authorities and consumer representatives as potentially dangerous for consumers
and users in general. For this reason, the assessment is strongly negative.
When it comes to the distinction of the impact from the Policy measure to the CLP and
Detergents Regulations, the interventions foreseen under policy measures 3 and 5
concerning consumer understanding and awareness of labels are seen positively both for
CLP and Detergents with no significant differences in the level of support from
stakeholders. In regards to Policy measure 4, stakeholders from public authorities and
industry both expressed support for the proposed interventions on the Detergents
Regulation rather than the CLP regulation under Policy Measure 4.
The second part of the assessment of effectiveness consists of analysing economic, social,
and environmental impacts.
Table 138: Assessment of the Policy measures vis-à-vis economic, social, and environmental impacts
Type of
impact
Policy Measure
1
Policy Measure
2
Policy
Measure 3
Policy Measure
4
Policy
Measure 5
Economic No or limited
impact
No or limited
impact
Weakly
positive
No or limited
impact
Weakly
positive
Social
impacts
Weakly
positive
Weakly
positive
Strongly
positive
Weakly
negative
Weakly
positive
Environme
ntal
No or limited
impact
No or limited
impact
Weakly
positive
No or limited
impact
No or
limited
impact
418
In terms of the economic impacts338
, none of the Policy Measures would bring strongly
positive economic impact. Nonetheless, Policy Measures 3 and 5 received the highest score
of all options. The full overview of the assessment of economic impacts is available in the
table below.
Table 139: Assessment of the Policy measures vis-à-vis specific economic impacts
Economic impacts Policy
Measure 1
Policy
Measure 2
Policy
Measure 3
Policy
Measure 4
Policy
Measure 5
Conduct of
business
Weakly
negative
No or
limited
impact
Weakly
positive
Weakly
positive
Strongly
positive
Sectoral
competitiveness,
trade and
investment flows
No or
limited
impact
No or
limited
impact
No or
limited
impact
No or
limited
impact
No or
limited
impact
Impact to the
SMEs
No or
limited
impact
No or
limited
impact
No or
limited
impact
Weakly
negative
No or
limited
impact
Technological
development /
digital economy
No or
limited
impact
No or
limited
impact
Strongly
positive
Strongly
positive
Strongly
positive
Impact to public
authorities
No or
limited
impact
Strongly
positive
No or
limited
impact
Strongly
negative
Strongly
negative
In terms of social impacts339
, Policy Measure 3 scored highest as stakeholders considered
this Policy Measure to have an overall positive impact on the safe use of products by the
consumers. There was a preference for the revisions to the CLP compared to the Detergents
Regulation. Meanwhile, Policy Measure 1, 2, and 5 received a positive feedback from public
authority stakeholders, and neutral or negative feedback from industry stakeholders. Policy
Measure 4 received the lowest score in this assessment because - even though industry
stakeholders estimated an overall positive impact on consumer safety under Policy Measure
4 - this option would entail the possibility for manufacturers to provide H and P statements
on online labels. This possibility is considered by public authorities and consumer
representatives as potentially dangerous for consumers and users in general, hence, the
lower score for Policy Measure 4 in terms of its impact on consumers.
Considering the environmental impact, none of the Policy Measure received very positive
feedback from the consulted stakeholders. However, industry and public authorities had an
overall positive opinion on Policy Measure 3 in terms of its impact on the awareness of
consumers of the impact of dispersion of harmful substances in the natural environment.
Public authorities estimate a positive impact of Policy Measure 2 and a negative impact of
Policy Measure 4 on the environment, while industry stakeholders hold the exact opposite
338
Conduct of business (BR Tools #21-25), Sectoral competitiveness, trade and investment flows (BR Tools
#21, 27), Impact to the SMEs (BR Tool #23), Technological development / digital economy (BR Tool #28),
and Impact to public authorities (BR Tool #58)
339
Impact to consumers and households (BR Tool #33).
419
view. Policy Measure 1 is considered to have no effect to the environment, while Policy
Measure 5 is considered to have a negative impact on the environment by both types of
stakeholders.
Efficiency
The assessment provides information regarding the potential costs and cost-effectiveness
for businesses. It should be noted that monetisation of costs was not feasible in all cases. In
particular, operational costs related to introducing and maintaining digital labels (costs
related to the implementation of IT solutions, maintaining website for the e-labels,
managing different data formats, costs associated with changes to design/packaging, etc)
could not be quantified. There was a similar challenge with regard to the benefits of
introducing digital labelling which could not be estimated due to the wide range of variables
affecting labels (e.g. size of the label, number of ingredients, type of chemical product, etc.).
A table describing the above mentioned costs in detail is provided below.
Table 140: Analysis of the quantifiable costs
Businesses Policy
Measure 1
Policy
Measure 2
Policy
Measure 3
Policy
Measure 4
Policy
Measure 5
Familiarisation
activities
(digital
labelling)
Undefined Undefined Three to four
FTEs who
would need 10
to 20 working
days to
conduct
familiarisation
activities (e.g.
training,
consulting) at
the company
level.
Note: under
Policy
measure 3,
businesses
would have to
decide
themselves if
they want to
turn to digital
labelling as it
would be done
in a voluntary
basis
Three to four
FTEs who
would need 10
to 20 working
days to
conduct
familiarisation
activities (e.g.
training,
consulting) at
the company
level.
Note: under
Policy
measure 4,
familiarisation
activities
would be
mandatory.
Three to four
FTEs who
would need 10
to 20 working
days to
conduct
familiarisation
activities (e.g.
training,
consulting) at
the company
level.
Note: under
Policy
measure 5,
familiarisation
activities
would be
mandatory.
Source: Survey on Policy Options
Most policy measures entail non-mandatory measures (i.e. the use of electronic labels is
always a choice of individual manufacturers and – by definition – if a company choses to
invest in the use of a digital tool such as an electronic label, the expected benefits would
420
outweigh the costs). Stakeholder perception on the costs-benefits ratio340
under each Policy
Measure is presented in the table below.
Table 141: Stakeholder perception on the cost-benefits ratio per policy option
Type of
stakeholder
Policy
measure 1
Policy
measure 2
Policy
measure 3
Policy
measure 4
Policy
measure 5
Industry Undefined Undefined Overall: -7%
CLP: -77%
Detergent: -
3%
Overall: 14%
CLP: 14%
Detergent:
7%
Overall: 34%
CLP: 35%
Detergent:
11%
Public
authorities
Undefined Overall: 27% Overall: 0% Overall: -
14%
Overall: -
16%
Source: Survey on Policy Options
Coherence
In terms of coherence, the criteria for the assessment of the policy measures are:
Coherence between CLP and Detergents regulations;
Coherence with digitalisation trends in the economy and other EU level and international
initiatives on the topic341
.
Table 142: Assessment of coherence sub-criteria
Effectiveness criteria Policy
measure 1
Policy
measure 2
Policy
measure 3
Policy
measure 4
Policy
measure 5
Coherence between
CLP and Detergents
No or
limited
impact
Strongly
positive
Strongly
positive
Weakly
positive
Strongly
positive
Digitalisation trend Weakly
positive
Undefined Strongly
positive
Strongly
positive
Strongly
positive
Concerning the first criterion, one of the specific objectives of the regulatory intervention
is to streamline and reduce overlaps or duplications due to incoherence between the two
regulations. The legal analysis, in Annex 13c, presents inconsistencies affecting physical
labels. All policy options, except Policy Measure 1, entail a streamlining of the two
regulations leading to increased coherence of the overall regulatory framework.
Regarding the comparison of the proposed policy options in terms of coherence with market
digitalisation trends, Policy Measure 1 and Policy Measure 2, the ones that do not entail the
possibility for manufacturers to provide information exclusively on electronic labels, score
340
Ratio of stakeholders who have indicated that cost and benefits under the Policy Option are high or very
high. If the ratio is negative it means stakeholders estimate higher costs than benefits under the option.
341
Results on the stakeholders’ perception on the coherence with the digitalisation trends is also included as
one of the economic impacts, namely “Technological development / Digital economy (Tool #28)”.
421
lower in comparison to options that allow the use of electronic labels to replace (even if
only partially) physical labels. From Policy Measure 3 onwards, the possibility to use
electronic labels would be coherent with other similar initiatives of the European
Commission related to the digitalisation of product information (i.e. the sustainable product
initiative and the digital product passport), but also with recent discussion of the GHS about
the possibility for a digital communication of hazards for chemical products.
A table comparing the overall assessment of key stakeholders and the median rating (from
-5 to +5) of the Policy Measures is presented in the table below.
Table 143: Stakeholders' opinion on the Policy Measures
Type of
stakeholder
Policy
measure 1
Policy
measure 2
Policy
measure 3
Policy
measure 4
Policy
measure 5
Public
authorities
Overall: 4
CLP: 4
Detergents 4
Overall: 4
Sub-option
2(a): 4
Sub-option
2(b): 4
Overall: 4
CLP: 3
Detergents 4
Overall: -2
CLP: -1
Detergents 2
Overall: 2
CLP: 1
Detergents 1
Industry Overall: -3.5
CLP: -3
Detergents: -
3
Overall: 1.5
CLP: 3
Detergents 4
Overall: 3
CLP: 2
Detergents 3
Overall: 5
CLP: 4
Detergents 5
Overall: 3
CLP: 3
Detergents
2.5
Source: Survey on Policy Options
The preferred policy option
According to the analysis performed, Policy Measure 3 is the overall preferred option
because it combines the necessary and widely requested simplification and streamlining
interventions foreseen under Policy Measure 2 with the possibility for businesses to adopt
digital labels. This solution as a first step,is considered positively by the majority of the
consulted stakeholders and strongly in line with the digitalisation trends. Summary of the
costs and benefits under the preferred option are in line with the Better Regulation
Guidelines, and is available in Annex 13d.
Policy Measure 3 is the only option that would have a strongly positive impact on both
specific objectives (SO) of this initiatve, namely:
SO1: improve consumer understanding and awareness of labels, by simplifying and
streamlining the existing labelling requirements in the Detergents regulation.
SO2: set up a future proof regulatory framework allowing the use of digital tools to
communicate product information.
In terms of effectiveness, Policy Measure 3 was ranked as the most effective Policy Measure
in terms of addressing social, and environmental impacts. Concerning social impacts,
consulted stakeholders consider the revisions under Policy Measure 3 to have an overall
positive impact on the safe use of products (with a preference for revisions to the Detergents
422
Regulation compared to the CLP). Moreover, Policy Measure 3 is as effective as Policy
Measure 5 in terms of its economic impacts.
In terms of the efficiency, industry stakeholders considered Policy Measures 4 and 5 as
more cost-effective than Policy Measure 3. Nonetheless, when it comes to public
authorities’ perception on costs and benefits of the Policy Measures that promote the use of
digital labels, Policy Measure 3 was the only option that did not receive an overall negative
assessment.
Most importantly, Policy Measure 3 was the only Policy Measure that received a very
positive overall assessment (median ≥ 3) from industry and public authority stakeholders.
Public authorities assessed the overall impact of Policy Measure 1, 2, and 3 as strongly
positive, while the industry had a general preference towards Policy Measure 3, 4, and 5.
Therefore, Policy Measure 3 is the only option that was assessed positively both by the
industry and public authorities.
To conclude, the analysis has shown that Policy Measure 3 is the overall preferred option.
It scores the highest overall in effectiveness and coherence, and is the most cost-effective
Policy Measure promoting the use of the digital labels according to the public authority
stakeholders.


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EUROPEAN
COMMISSION
Brussels, 19.12.2022
SWD(2022) 435 final
PART 4/5
COMMISSION STAFF WORKING DOCUMENT
IMPACT ASSESSMENT REPORT
Accompanying the document
Proposal for a Regulation of the European Parliament and of the Council
amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council
on classification, labelling and packaging of substances and mixtures
{COM(2022) 748 final} - {SEC(2022) 452 final} - {SWD(2022) 434 final} -
{SWD(2022) 436 final}
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KOM (2022) 0748 - SWD-dokument
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455
Annex 13b – Factual Summary of the responses to
the Open Public Consultation (digital labelling)
Disclaimer: This document should be regarded solely as a summary of the contributions
made by stakeholders during the public consultation on the Impact Assessment study on the
simplification of the labelling requirements for chemicals and the use of e-labelling. It
cannot in any circumstances be regarded as the official position of the Commission or its
services. Responses to the consultation activities cannot be considered as a representative
sample of the views of the EU population.
INTRODUCTION
The objective of the public consultation, which ran between November 2021 and February
2022 was to gather experiences and opinions from various stakeholders (consumers,
professional and non-professional product users, industry, civil society organisations,
national authorities and any other interested stakeholders) on a possible introduction of
digital labelling of many daily used chemical products such as glues, laundry and
dishwashing detergents and fertilising products, under the Regulation on Classification,
Labelling and Packaging of substances and mixtures (‘CLP’)1
, the Detergents Regulation2
and the Fertilising Products Regulation3
.
The consultation was available and respondents could reply in any of the 24 official EU-
languages.
The Public Consultation (PC) questionnaire was divided into four major parts.
The first part concerned the questions about the background of the surveyed stakeholders.
The second part included the general questions on the knowledge, habits, preferences, and
opinions of the stakeholders on certain elements of (digital) labelling.
The third part focused on the specific questions for products users regarding fertilisers,
detergents, and chemicals.
The last part included specialist questions for professionals and industry concerning digital
labelling.
1
Regulation (EC) No 1272/2008 of the European Parliament and of the Council, of 16 December 2008 on
classification, labelling and packaging of substances and mixtures, amending and repealing Directives
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
2
Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents
3
Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules
on the making available on the market of EU fertilising products and amending Regulations (EC) No
1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003
456
BACKGROUND OF THE PARTICIPANTS
In total, 205 stakeholders have participated in the public consultation. The following is an
overview of the respondents regarding the type and the size of the organisations they
represent as well as the country they are from.
Which type of organisation do you represent?
Among the 205 respondents to the public consultation, 133 respondents are representatives
of the chemical industry (96 companies/business organisations, 36 business associations,
and 1 trade union), 53 can be considered as consumer representatives (3 consumer
organisations, 47 EU citizens, 2 non-EU citizens, and 1 NGO), 10 are public authorities,
and 9 identified as Other.
Respondents: N = 205
Organisation size
Among the 156 respondents to this question, almost half of them are from a large
organisation with more than 250 employees (76 respondents), while the three other
categories are evenly represented.
Respondents: N = 156
Which country are you from?
Among the 205 respondents to the public consultation, more than 1 out of 4 are from
Germany, followed by France, Belgium, Spain and the Netherlands being the most
represented countries. Bulgaria, Estonia, Greece and Luxembourg were the least
0,5%
0,5%
1,0%
1,5%
4,4%
4,9%
17,6%
22,9%
46,8%
Non-governmental organisation (NGO)
Trade union
Non-EU citizen
Consumer organisation
Other
Public authority
Business association
EU citizen
Company/business organisation
15%
17%
19%
49%
Medium (50 to 249 employees) Small (10 to 49 employees)
Micro (1 to 9 employees) Large (250 or more)
457
represented of the EU Member States, while no participant to the survey was from Croatia,
Cyprus, Ireland, Latvia, Malta and Slovenia.
Respondents: N = 205
GENERAL QUESTIONS
In this part of the questionnaire, the respondents were asked to share their experience on
their knowledge, habits, preferences, and opinions on certain elements of (digital) labelling.
Q1. What is your age group?
Among the 61 stakeholders who have provided information concerning their age group,the
majority were 45 years old or older (67%), 45-54 years old age group being the largest
compared to the other age groups in size.
0,5%
0,5%
0,5%
0,5%
0,5%
0,5%
0,5%
0,5%
1,0%
1,0%
1,0%
1,0%
1,5%
1,5%
2,0%
2,4%
2,9%
3,4%
3,4%
3,9%
3,9%
3,9%
4,4%
6,3%
6,8%
9,8%
10,2%
25,9%
0,0% 5,0% 10,0% 15,0% 20,0% 25,0% 30,0%
Bulgaria
Canada
Estonia
French Polynesia
Greece
Luxembourg
Norway
Romania
Lithuania
Slovakia
United Kingdom
United States
Israel
Switzerland
Hungary
Austria
Finland
Portugal
Sweden
Czechia
Denmark
Poland
Italy
Netherlands
Spain
Belgium
France
Germany
458
Respondents: N = 61
Q2. Please rate your knowledge of the following
The majority of the respondents declared having an expert or a good knowledge on the
interaction between CLP Regulation and other Regulations (61%, 119 out of 196), and on
the CLP Regulation (76%, 149 out of 196). However, the majority of the respondents
indicated having average to no knowledge of the Fertilising Products Regulation (64%, 114
out of 178), as well as average to no knowledge of the Detergents Regulation (51%, 92 out
of 179).
3%
15% 15%
39%
21%
7%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
18-24 years
old
25-34 years
old
35-44 years
old
45-54 years
old
55-64 years
old
65-74 years
old
18%
27%
10%
10%
19%
16%
4%
9%
15%
20%
10%
20%
23%
15%
29%
26%
25%
22%
47%
35%
0% 25% 50% 75% 100%
Fertilising Products Regulation
Detergents Regulation
CLP Regulation
The interaction between CLP Regulation and
other Regulations
No knowledge/ understanding Little knowledge/ understanding
Average knowledge/ understanding Good knowledge/ understanding
Expert knowledge/ understanding
459
Q3. Do you usually understand the information provided on the label of a:
Respondents: N=186 for “Chemical product such as a glue or paint”, N=177 for “Detergent”, and N=171 for
“Fertilising Product”
The majority of the respondents understand the information provided on the label to some
or a full extent for all of the products mentioned in the graph above.
The analysis of the answers given specifically by citizens4
also leads to the same conclusion,
with 69% of respondents answering “Yes” or “Yes to some extent” for chemical products5
,
71% for detergents6
, and 53% for fertilising products7
.
Q4. In which ways, do you consider that the communication of information on labels
of chemicals could be improved (multiple options available):
Respondents believe (mostly industry stakeholders) that the most effective method to
increase the communication of information on labels of chemicals is by simplifying the text
on labels, having less information on the on-pack label and instead of providing full details
via digital labels, and by using more pictograms or graphic symbols instead of text8
.
In addition, answers given by consumer representatives9
and public authorities10
show that
reducing the number of additional languages on labels would be most effective to improve
the communication of information.11
On the other hand, the least effective ways to increase the communication, according to the
respondents, were having more detailed information provided on the on-pack label (e.g.
more detailed use instructions, etc.), having all information only provided via IT solutions
4
EU and non-EU citizens, respondents : N=49.
5
34 out of 49 answers.
6
35 out of 49 answers.
7
26 out of 49 answers.
8
These options have collected 407 out of 675 (61%) votes out of the total choices.
9
31 out of 53 respondents representing consumers (citizens and consumer associations).
10
Four out 10 respondents (40%) representing public authorities.
11
31 out of 53 respondents representing consumers (citizens and consumer associations).
15% 6%
14%
12%
14%
28%
22%
64%
55%
63%
0% 25% 50% 75% 100%
Fertilising Product
Detergent
Chemical product such as a glue or paint
I do not use such products Not at all Some of it Yes, to some extent Yes
460
and not on the on-pack label, and/or not doing any changes and keeping the current situation
as it is12
.
Q5. Do you currently access any product information via IT solutions or digital tools?
The majority of the respondents (124 out of 174) have currently accessed product
information via IT solutions or digital tools. More specifically, around 78% of respondents
from the industry answered positively to this question13
, and 62% of respondents
representing consumers14
.
Q6. How often do you look for product information online (for any product)?
The majority of the respondents look for product information online (for any product) daily
or weekly15
. Only two respondents look for product information online (for any product)
once a year or less.
This finding can be mitigated when looking specifically at answers given by consumer
representatives where just about a third of them look for product information online only a
few times a year.16
Q7. In the context of the below chemical products, how would you evaluate it if some
information was removed from the on-pack label and could only be obtained via digital
labels?
The majority of the respondents17
think that, in the context of the below chemical products,
removing some of the information from the on-pack label to the digital labels would have a
moderately positive or a very positive effect overall.
12
These options have collected 37 out of 675 (6%) votes out of the total choices.
13
85 out of 109 answered “Yes”.
14
31 out 50 answered « Yes ».
15
73 out of 121 (61%) respondents who have answered these questions have selected either of these two
options.
16
11 out of 31 respondents (while 5 answered “daily”, 8 ”weekly”, and 7 “monthly”).
17
125 out of 180 respondents who have answered to a part on the other chemical products such as glues, lamp
oils, paints, solvents, etc., 112 out of 165 respondents who have answered to a part on the detergents, and 103
out of 153 respondents who have answered to a part on the fertilising products.
461
Respondents: N = 153 for Fertilising Product, N= 165 for Detergents, and N = 180 for other chemicals.
However, the analysis of answers given by citizens and consumer organisations reveal
mixed views within this category group, with respondents being equally divided for each of
the abovementioned chemical products, between a negative or a positive impact of moving
some information on a digital label.18
Q8. If labelling information of a product would be available via IT solutions, what
device would you prefer to use to access this information? (multiple choice possible)
The most popular choices by all stakeholder groups, to access the labelling information via
IT solutions were smartphones, laptops, tablets, and desktop computers19
.
Q9. What digital solution would you prefer to use, to access the information online?
Close to two-thirds of the respondents (258 out of 398 ) from all stakeholder groups would
prefer to use QR codes and website addresses to access the information online20
, while
around 13% of the respondents do not have a preference for the digital solution as long as
it would work with their preferred device.
Q10. In your view, what would be the main benefits of presenting some label
information via IT solutions?
There was no clear consensus among the respondents of any of the stakeholder groups on
the main benefits of presenting some label information via IT solutions as the opinions on
this question were rather marginalised. This illustrates the respondents’ opinion that there
are multiple and diverse benefits regarding the presentation of some label information via
IT solutions.
18
For ‘other chemicals’, 25 out of 52 respondents expressed a very negatively or a moderately negatively
impact, and 24 out of 52 expressed a moderately positively or very positively impact. For detergents, 21 out
of 49 respondents expressed a very negatively or a moderately negatively impact, and 22 out of 48 expressed
a moderately positively or very positively impact. For fertilising products, 23 out of 47 respondents expressed
a very negatively or a moderately negatively impact, and 18 out of 47 expressed a moderately positively or
very positively impact.
19
These options have collected 536 out of 615 (87%) votes out of the total choices.
20
These options have collected 258 out of 398 (65%) votes out of the total choices.
12%
13%
12%
12%
10%
10%
21%
26%
27%
46%
42%
43%
0% 25% 50% 75% 100%
Fertilising Products
Detergents
Other chemical products such as glues, lamp oils,
paints, solvents, etc.
Very negatively Moderately negatively
Neither positively nor negatively Moderately positively
Very positively Other
462
Respondents: N= 200
Q11. In your opinion, what would be the main challenges of presenting some label
information via digital labels?
The majority of the stakeholders (mostly industry stakeholders) responded that the biggest
challenges of presenting some label information via digital labels would be: the difficulty
to access information (e.g. poor internet connection, lack of electricity); potential
differences between the information displayed on the on-pack label and via digital labels
(e.g. due to updates, inconsistencies), and creating inequalities for certain population
groups.21
The analysis of answers given by consumer representatives and public authorities found the
same three main challenges of presenting some information via digital labels. However,
within this stakeholder group, the possibility of creating inequalities for certain population
groups was the most common answer.22
SPECIFIC QUESTIONS FOR PRODUCT USERS
In this part of the questionnaire, all the respondents (all users of relevant products) were
first asked to indicate which chemical products they use (i.e. ‘other chemicals’, detergents,
fertilising products), and then they were asked to share their experiences about the ones they
had indicated to use.
21
These options have collected 339 out of 491 (69%) votes out of the total choices.
22
40 out of 53 respondents representing consumers, and 9 out of 10 respondents representing public
authorities.
4%
8%
10%
11%
13%
13%
13%
14%
14%
0% 2% 4% 6% 8% 10% 12% 14% 16%
Other
Cost savings
Environmental benefits
More relevant/targeted information
The possibility to provide information in additional languages
The possibility to have updated information (e.g. for products purchased a
long time ago)
Ease of accessing information (e.g. quick searches, zooming in on text, etc.)
The possibility to provide all relevant information also in cases where the
packaging is too small to have all information on the on-pack label
The possibility to provide more detailed information
463
Q12. Do you use the following:
91% of respondents indicated they use ‘other products’ and 91% indicated they use
detergents, while 65% of respondents use fertilising products in some capacity (at work or
at home).
Q12a. Which type of fertilising product/s do you use? (multiple choice possible)
The most popular choice of fertilising product used by the respondents was fertiliser23
followed by growing medium24
. The least popular selected type of fertilising product was
the inhibitor25
.
Q13-14-15 When do you read the label of a fertilising, detergent and other chemical
products? (multiple choice possible)
The respondents read the label of ‘other chemicals’, detergent or fertilising product at
different times. In all three cases, the option “Before purchase”26
was slightly preferred,
followed by “After purchase but before using the product”27
, and “In case of
problems/accidents”28
.
23
107 out of 314 votes out of the total choices.
24
55 out of 314 votes out of the total choices.
25
21 out of 314 votes out of the total choices.
26
121 out of 328 votes out of the total choices for the chemical products, 96 out of 287 votes out of the total
choices for the detergents, 88 out of 212 votes out of the total choices for the fertilising products.
27
104 out of 328 votes out of the total choices for the chemical products, 86 out of 287 votes out of the total
choices for the detergents, 70 out of 212 votes out of the total choices for the fertilising products,
28
78 out of 328 votes out of the total choices for the chemical products, 76 out of 287 votes out of the total
choices for the detergents, 44 out of 212 votes out of the total choices for the fertilising products,
35%
9%
9%
42%
65%
53%
11%
5%
12%
13%
22%
25%
0% 25% 50% 75% 100%
Fertilising Products
Detergents
Other Chemical Products (e.g. glues paints, lamp
oils, solvents, etc.)
No Yes, I use them at home Yes, I use them at work Yes, I use them at home and at work
464
Q16. Thinking about the last time you used a Detergent product - in your opinion, does
the information on a Detergent label… (see possible answer options below):
The majority of the respondents think that the information on a detergent label:
 Allows to use the product properly (e.g. correct dosage, wear protective equipment,
etc.) (126 out of 149)29
;
 Motivates to take appropriate preventative measures to avoid accidents (96 out of
146)30
;
 Properly informs about safe use (126 out of 147)31
;
 Properly informs about the dangers or risks associated with using the product (123
out of 150)32
.
However, the majority of the respondents also think that the information on a Detergent
label does not:
Prevent from using the product (125 out of 143)33
;
Encourage to select a less hazardous product (114 out of 143)34
.
Q17. Thinking about the last time you used a chemical product (like a glue, paint, lamp
oil, solvent, etc.) - in your opinion, does the information on a label … (see possible
answer options below):
Likewise, as per the previous question, the majority of the respondents think that the
information on a chemical product label:
29
126 out of 149 respondents (85%) have selected options “Yes” or “Yes, to some extent”.
30
97 out of 146 respondents (66%) have selected options “Yes” or “Yes, to some extent”.
31
126 out of 147 (86%) respondents have selected options “Yes” or “Yes, to some extent”.
32
123 out of 150 (82%) respondents have selected options “Yes” or “Yes, to some extent”.
33
125 out of 143 (87%) respondents have selected options “Not at all” or “Not always”.
34
114 out of 143 (80%) respondents have selected options “Not at all” or “Not always”.
33%
30%
32%
42%
33%
37%
21%
26%
24%
0% 25% 50% 75% 100%
Fertiliser
Detergent
Chemical
After purchase but before using the product After the first use of the product
Before purchase In case of problems/accidents
Never Other
465
Allows to use the product properly (e.g. correct dosage, wear protective equipment,
etc.)35
;
Motivates to take appropriate preventative measures to avoid accidents36
;
Properly informs about safe use37
;
Properly inform about the dangers or risks associated with using the product38
.
The majority of the respondents also think that the information on a chemical product label
does not:
Prevent from using the product39
;
Encourage to select a less hazardous product40
.
35
123 out of 158 respondents (78%) have selected options “Yes” or “Yes, to some extent”.
36
110 out of 156 respondents (71%) have selected options “Yes” or “Yes, to some extent”.
37
133 out of 157 (85%) respondents have selected options “Yes” or “Yes, to some extent”.
38
125 out of 157 (86%) respondents have selected options “Yes” or “Yes, to some extent”.
39
126 out of 151 (83%) respondents have selected options “Not at all” or “Not always”.
40
115 out of 154 (75%) respondents have selected options “Not at all” or “Not always”.


EN EN
EUROPEAN
COMMISSION
Brussels, 19.12.2022
SWD(2022) 435 final
PART 3/5
COMMISSION STAFF WORKING DOCUMENT
IMPACT ASSESSMENT REPORT
Accompanying the document
Proposal for a Regulation of the European Parliament and of the Council
amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council
on classification, labelling and packaging of substances and mixtures
{COM(2022) 748 final} - {SEC(2022) 452 final} - {SWD(2022) 434 final} -
{SWD(2022) 436 final}
Offentligt
KOM (2022) 0748 - SWD-dokument
Europaudvalget 2022
423
Annex 13a – Stakeholder consultation – Synopsis
report (digital labelling)
INTRODUCTION & CONSULTATION STRATEGY
Data collection for this study has been performed using the following tools: legal review,
desk research, interviews (scoping interviews and stakeholder interviews), online surveys
and behavioural experiments. The results of the public consultation run by the European
Commission has also been integrated in the analysis.
Stakeholder consultation activities were conducted at different stages of the study:
Interviews (April-December 2021): to collect information related to the current
understanding of chemical labels, the usefulness of information provided to users, the
assessment of labelling requirements and needs of users, as well as the existing digital
solutions available for e-labelling.
Behavioural experiment (September-October 2021): to investigate consumers’
understanding of chemical and detergents labels, the importance of different label elements
as well as their interpretation with respect to safe use.
Inception Impact Assessment
Public Consultation (November 2021-February 2022): It must be noted that only the
findings of this consultation related to the CLP Regulation (e.g. chemical products in
general) are presented in this synopsis report.
Online surveys (Two online surveys are conducted for the purpose of this study: a survey
for industrial and professional users and a survey for the assessment and comparison of
policy options.
Regarding the country coverage, the consultation covered the EU-27, except for the
behavioural experiment which has been conducted in four EU Member States (Germany,
France, Romania and Greece).
CONSULTATION ACTIVITIES AND TOOLS
Interviews
Firstly, the study team conducted 10 scoping interviews with EU and international experts
on labelling requirements and the use of digital tools to communicate hazard and safety
information and instructions to users. Scoping interviews help to familiarise further with the
topic and understand its main challenges. The objectives of the scoping interviews were to:
Ensure that the study team is aware of all relevant background documentation and
latest regulatory developments in the field;
Collect contact details of relevant stakeholders to be contacted during the data
collections exercises (i.e., identifying potential future interviewees);
424
Raise awareness among stakeholders of the study and its benefits and enlist their future
cooperation.
In a second phase, interviews were conducted with various types of stakeholders involved
in labelling requirements of chemicals and the use of digital tools to communicate hazard
and safety information and instructions to users.
The objectives of the interviews were to collect stakeholders’ feedback on different topics
related to the labelling of chemical products and e-labelling, including:
Perceived current understanding of chemical labels by different categories of users;
The usefulness and relevance of information provided currently on chemical labels;
The assessment of labelling requirements and needs of users;
The analysis of existing IT solutions available for e-labelling;
Identification of information that should remain on the physical label and suggestions of
information to put on an e-label for chemical products.
In total 41 interviews have been conducted with the following categories of stakeholders:
 European and national authorities;
 11 NGOs, including 8 consumer associations;
 25 Business representatives (from business associations and companies).
While all categories of stakeholders targeted for this stakeholder consultation have been
reached, it must be noted that, among the respondents, a majority of them are representing
the interests of the industry. This imbalance and the interests represented by this category
of stakeholders have been taken into account in the analysis of the findings of the interviews.
Behavioural experiment
The aim of the behavioural experiment was to investigate consumers’ understanding of
chemical and detergents labels, the importance of different label elements as well as their
interpretation with respect to safe use. Furthermore, the experiment tested potentials ways
to simplify labels and whether the introduction of digital tools could support consumers.
Therefore, a state-of-the-art online experiment was designed that included six treatments,
i.e. two different products (laundry detergent and glue) as well as three different labelling
options (Status Quo Label in accordance with current regulation, Simplified Label with QR-
Code and No Label Baseline). Participants were incentivised for taking part in the study as
well as for their decisions in the different tasks. Furthermore, treatment assignment was
fully randomised.
Although representative products and labels were used in the experimental design and
participants were tracked when consulting the labels presented on screen, it must be noted
that the experiment can only mimic reality, i.e. a situation of consulting a label in everyday
life. Main data collection was conducted in four Member States, i.e. Germany, France,
Romania and Greece, and a total of N=4,003 consumers took a part in the study.
Participants were recruited from an actively managed online panel and quotas to reach
representativeness of the country-specific samples were used.
425
Public Consultation - Simplification and digitalisation of labels on chemicals
This consultation, run by the European Commission, aims to gather experiences and
opinions from various stakeholders (consumers, professional and non-professional product
users, industry, civil society organisations, national authorities and any other interested
stakeholders) on a possible introduction of digital labelling of many daily used products
such as glues, laundry and dishwashing detergents and fertilising products, under the
Regulation on Classification, Labelling and Packaging of substances and mixtures (‘CLP’),
the Detergents Regulation and the Fertilising Products Regulation.
The findings presented in this synopsis report and integrated in the report represent an
analysis of the responses collected on 17 February, with 205 respondents.
These answers have been divided by stakeholder categories: 141 from the private sector
(companies, business associations, trade unions), 11 from public authorities, and 53 from
consumers’ representatives (48 citizens, 4 consumer association and 1 NGO). Similarly as
the interview analysis, the imbalance of representation among stakeholders groups and their
different interests has been taken into account when processing the answers.
Online survey on policy options
This consultation, run by VVA, aimed at gathering the opinion of the various stakeholders
(consumers, professional and non-professional product users, industry, civil society
organisations, national authorities and any other interested stakeholders) on the latest
version of policy options analysed in this study. This survey allowed stakeholders to provide
a punctual opinion on the measures taken into consideration for this analysis.
The answers have been divided by stakeholder category: 1414 member state authorities,
6767 industry representatives (industry associations, businesses).
Online survey for professionals and industry users
The aim of the survey was to collect information from the stakeholders representing
professionals and the industry on the importance of having certain pieces of information1
on the packaging of the specific chemical products2
as well as the easiness to understand
the information concerning these elements in these products.
In total, 50 stakeholders participated to this survey: 11 Member States authorities, 10
industry associations, 28 enterprises, and 1 consumer organisation.
1
Name of the product; Address and telephone number of the supplier; Instructions for use; Dosage
recommendations; Marketing information; Quantity; List of ingredients contained in the product, such as
allergens, preservatives or enzymes; Weblink to receive full ingredients list; Information relevant in case of
intoxication e.g. poison centre telephone number; UFI-code etc.; Hazard pictogram; Signal word, i.e.,
“Warning” or “Danger”; Statements on the products hazards for human health environment and physical
hazards; Statements on the precautions to be taken on the use, storage and disposal of the product; Statements
on how to prevent and minimise adverse effects when accidentally exposed.
2
Laundry detergents; Cleaning detergents; Glues; Paints; Sealants or fillers.
426
MAIN STAKEHOLDER FEEDBACK PER CONSULTATION ACTIVITY
Interviews
Consumers’ understanding of chemical labels
First of all, during the interviews, stakeholders were asked about their perspectives on the
current level of understanding of chemical and detergents labels by the various categories
of product users (e.g. consumers, industrial workers, professional users).
A majority of stakeholders from both the business sectors (22 out of 24) and consumer
associations (6 out of 10) believes that, the chemical labels (including detergents) as they
are now, are not well understood by consumers, for a variety of reasons. First of all, the
main arguments highlighted that would explain a poor understanding of chemical labelling
by consumers rely on the fact that consumers do not spend enough time reading the label
(only a few seconds, except in case of accidents), and interpret them quickly and intuitively.
Moreover, the overloaded character of labels and the long texts in small prints (as
highlighted by all categories of stakeholders) reduce the readability and understanding of
labels. Secondly, stakeholders from all categories have also underlined the use of technical
terminology (e.g. chemical names) as an obstacle for consumers’ understanding. Finally,
while stakeholders from the business sector also argued that GHS pictograms are not well
understood by consumers, stakeholders representing national authorities and consumers
associations underlined the fact that consumers know pictograms and that they are better
understood than texts. However, it must be noted that consumers’ understanding of chemical
labels can be very heterogeneous across Europe, with, for example, two stakeholders from
Denmark highlighting the fact that there is a high awareness and understanding of chemical
labels among consumers, especially thanks to a highly-educated population, consumer
associations and national authorities actively informing consumers.
Secondly, understanding of chemical labels can be very heterogenous between on one hand
consumers, and on the other hand professional users and industrial workers. Indeed,
stakeholders from all categories have pointed out a clear difference in understanding of
hazard and safety instructions communicated on chemical labels. This difference is
explained by the fact that professional and industrial workers get training to understand
information and have access to additional tools in addition to chemical labelling (e.g. the
Safety Data Sheet).
Usefulness of information provided on chemical products labels in general
During interviews, stakeholders have been asked to discuss, among the information
currently provided on labels, which information they found particularly important to be
provided for consumers’ use and safety, and which information they deemed non-essential.
This section discusses the feedback received from stakeholders on the usefulness of
different types of information provided on chemical labelling in general, meaning for all
types of chemicals according to the labelling requirements provided in the CLP Regulation.
First of all, stakeholders from all categories agreed that hazard information (encompassing
notably the hazard statements) was one of the most useful information to be conveyed to
consumers. However, they also noted that in some cases there could be an overlap or a
redundancy of information given between the hazard statements and the precautionary
427
statements, and that this redundancy could be addressed to simplify and optimise space on
the label, by testing for example if only one of the statements is enough to convey safe use
instructions to consumers, or if a more meaningful combination of hazard and precautionary
statements could be put in place.
Indeed, communicating information on the safe and appropriate use of products to
consumers – notably through precautionary statements – was agreed by all stakeholders to
be the most important type of information to be communicated on chemical labels, including
information related to the safe (and sustainable) use (e.g. purpose of product, how to use the
product, and with which equipment), information on safe storage of the products (e.g. keep
away from children), and information in case of emergency situations. However, it was also
argued by several industry representatives that the pictograms developed by A.I.S.E and
used on a voluntary basis on chemical products could replace or complement a number of
precautionary statements, and communicate the required information as effectively (or
more), while also avoiding the issue of translating. The idea is that pictograms
communicating certain risks are very important because consumers notice them first and
can be seen as precautionary statements but in an improved format. Indeed, some
stakeholders from both the business sectors and consumer associations explained that, as
they are now, some precautionary statements are presented on the label as long sentences in
small font, which are not easy to read and or understand, and could therefore be displayed
differently (better wording, illustration with pictograms…). Overall, regarding
precautionary statements, the main idea emerging from interviews is that, while their
content constitutes one of the main information to be communicated to consumers (safe use
of the products), the form could be improved.
Thirdly, the presence of pictograms on chemical labels reached a consensus among
stakeholders about their usefulness and therefore the need to be favoured over texts. A
couple of stakeholders from the industry and national authorities raised doubts about
consumers’ understanding of GHS pictograms. Nonetheless, several consumer associations
pointed out that their usefulness also lies in the fact that they are important for catching the
consumers’ attention and prompt them to read the hazard statement.
Regarding the communication on chemical labels of the ingredient lists and information on
ingredients, all types of stakeholders agreed about the importance to communicate classified
ingredients to consumers, especially sensitizing substances when contained in some specific
product categories. However, concerning the communication of the full list of ingredients,
stakeholders from the industry suggested that not all consumers are interested in chemical
ingredients, read, or understand them. Therefore, it was suggested that the ingredients
information may not be the most useful element on the physical label and could be better
provided on an e-label together with additional explanations about why they trigger
classification and what are their properties. To the opposite, it has also been suggested by a
consumer association that the full ingredients list should be disclosed on chemical labels (as
is the case for cosmetics), as it is very important for consumers and for the authorities to be
able to know exactly which chemicals are contained in which products. If maybe most
consumers indeed do not look at the list, but it is still important for them to know that there
is a full disclosure accessible on the physical label of the product, and to have access to it
in case of emergency.
Then, the presence of the recently added UFI code was deemed most useful to be
communicated on chemical labels. Indeed, if alone it does not give any information to the
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consumers, when there is an accident, it is essential for consumers to be able to find it easily
to be able to communicate it to the poison centre.
Finally, the role of the marketing information on chemical products was also debated. As
mentioned above, it is very important for the industry to dedicate significant space to this
type of information, however several consumer associations put in evidence that it reduces
the room for other more important information about safe use. They suggested that, in the
first place, it should be ensured that all the essential information for the safe and appropriate
use of the product should be presented in clear and legible manner (with the possibility to
have a minimum font size), and then the remaining room would be dedicated to marketing
information.
Usefulness of information detergents’ labels
This section will discuss the feedback received from stakeholders on the usefulness of
different types of information specifically on detergents, where additional requirements can
exist on top of those provided in the CLP Regulation coming from the Detergents
Regulation.
First of all, the dosage instructions were considered most useful by all types of stakeholders
to be conveyed to consumers, in order to guide appropriate use of the product, since this can
have an impact on the product performance and also on the environment (risk of
overdosing). However, it has also been suggested that it could be simplified compared to
how it is presented now (e.g., the obligation to have a dosage grid based on water hardness),
for example by providing on the physical label one example of dosage for the general use
of the product, and provide more detailed information online (such as instructions for
different machines, load and water), and to adapt standard dosing advice to the current use.
Secondly, information on allergens and sensitisers which can be contained in detergents,
was also considered to be of the utmost importance by most stakeholders. Indeed, the
information about the presence of allergens and sensitisers in a product is deemed essential
also by business operators because it would be well understood by the concerned consumers.
Contrary to average consumers, persons concerned by an allergy or a sensitivity to a specific
substance will look for the presence of these substances and most likely understand the
information on the label. However, stakeholders from business the sector argued that
concerning the communication of ingredients information, there is no need to have other
requirements in addition to the ones from the CLP Regulation (e.g. the Detergents
Regulation requires to name the substance group such as anionic surfactants, or the
amount/percentage of substances in the product). A couple of representatives of national
authorities agreed to some extent to this point, to the exception of allergenic fragrances in
the case that they are not already labelled according to CLP, since lower concentration limits
are set under the Detergents Regulation, information on whether detergents contain added
perfumes. This point showed a divergence of opinions among consumer associations.
Indeed, a couple of them agreed that the list of all substances and ingredients communicated,
especially on detergents due to additional requirements, is too long, never read and not
understood, and therefore could be simplified. However, other consumer associations
argued that the full ingredient lists (as for cosmetics) are needed and getting information on
ingredients should be a common way for products, easily accessible. For now, they pointed
out that consumers do not even know that this information is accessible on manufacturers’
websites (for detergents, according to the Detergents Regulation).
429
Finally, some products can also contain biocidal substances and therefore need to comply
with the requirements of both the Biocidal Products Regulation and the Detergents
Regulation. In these cases, biocidal information was also considered as most useful by
stakeholders to be conveyed on chemical labels.
Feedback on chemical labels design (including detergents)
The quantity of information on the label is not the only factor that can have an impact on
consumers’ understanding and appreciation of chemicals’ labels. To this regard, during
interviews, stakeholders have been asked to give their opinions on label design (e.g. font,
colour, size…) and in particular to suggest what could be removed, changed, or added to
improve users’ understanding and appreciation of labels.
First of all, all types of stakeholders have pointed out the issue of font size and colour of
texts on chemical labels. Indeed, texts are often written in small prints on packages and/or
in different colours, which can hamper their readability. To this regard, stakeholders from
consumer associations and national authorities have pointed out that mandatory rules on
minimum font size, and to some extent regarding text and background colours, contrast, or
bold text, could be useful for the overall readability of labels. Moreover, it has been argued
that rules on minimum font size for texts on chemicals’ labels could also be useful to reduce
the abusive addition of languages by industry representatives.
Secondly, all types of stakeholders have also highlighted the possibility to use more
pictograms, and/or to make them bigger, especially since they are attracting the eyes of the
consumers to read the label. In particular, stakeholders from the industry have argued that
the pictograms developed by A.I.S.E communicating hazard and safety information are well
understood by consumers and could be put forward.
Finally, stakeholders have also made several suggestions regarding the structure of safety
and hazard information on labels, such as the possibility to develop dedicated areas for
communicating safety and hazard information vs. safe use instructions, to make safety and
hazard information more prominent, or to make website links (or other data carrier to a
digital environment) more noticeable to encourage consumers to seek complementary
information. It has also been suggested by a consumer association that grouping information
by languages is also a good way to improve readability, since consumers would not have to
look at different places on the label to get all the information provided.
Perspectives on multilingual labels
The legal requirements under the CLP Regulation specify that information on labels should
be available in the official language(s) of the country in which the product is distributed.
This makes multilingual labels mandatory in countries with more than one official language.
Nonetheless, multilingual labels are a common practice in the industry across all countries.
Business representatives explained that multilingual labels are used to achieve economies
of scale, and one business association also mentioned e-commerce which must
accommodate the needs of consumers coming from a wide range of countries. According to
businesses and business associations multilingual labels allow the industry to produce one
label for several countries, which is particularly useful when businesses have to distribute a
product in countries with a low population and different languages (e.g., Baltic countries).
430
They also mention that scale through multilingual packs saves money and materials, allows
a bigger flexibility in planning, and reduces scrapping. In addition, stakeholders from the
business sector explained that if companies had to produce quantities of products separately
for each and every market, the exercise would be so complex that companies might abandon
smaller markets, thus depriving consumers from future innovations.
However, it must also be noted that a couple of stakeholders from the chemical industry
acknowledged the issue caused by too many languages on chemical labels, leading to their
illegibility, and called for more guidelines and/or rules, for example on required font size,
or on a maximum number of languages authorised. The latter suggestion was strongly
opposed by other stakeholders from the business sector, who have argued for a freedom of
the industry on this point as long as the principles of accessibility and readability are
respected.
Finally, in order to reduce this tension between the ultimate objective to communicate
effectively hazard and safety information as well as use instructions to consumers, and their
need to produce multi-lingual labels, stakeholders from the business sector explained that
the simplification of labels, in other words the optimisation of labels with less information
provided on pack was essential in their opinion.
On the other hand, national authorities put in evidence that featuring multiple languages
makes labels hard to read at the expense of communicating important safety and hazard
information. In their view reducing languages on the label would allow more room for
presenting essential information in a clear and legible manner. For this reason, they also
suggested establishing rules on how many languages can be presented on labels. One
advisory authority believes regulation should focus on specifying the minimum font size
rather than directly limit the number of languages. Moreover, these stakeholders pointed out
that while they acknowledge situations where multi-lingual labels are interesting and needed
for consumers (e.g. second and third languages spoken in Germany are Turkish and Arabic),
often, in reality, when manufacturers put multi-lingual, it is only driven by economic
reasons, and not to help consumers. In their opinion, while it is true that multi-lingual labels
contribute to further complete the single market and can be beneficial economically, when
it clashes with readability and conveying safety information, the functioning of the single
market has to take a step back.
Consumer associations had similar views to those of the national authorities in this regard,
highlighting also that the purpose of multi-lingual labels would be to meet consumers’ needs
in the specific countries, and proposing to add additional languages only if there is adequate
space left on the label after essential information for safety and hazard was included in a
readable manner in the official language(s) required. Furthermore, while understating what
are the needs of the industry with multi-lingual labels, stakeholders from consumer
associations suggested to limit the number of languages to be provided on chemical labels
(in between 2 or 3 depending on stakeholders).
Feedback on the potential use of IT tools for chemical labelling
Finally, the second part of the interviews focused on the potential use of IT tools to
communicate hazard and safety information to consumers. We have discussed with
stakeholders about the different IT tools existing for e-labelling and which ones would be
the most interesting to use for chemicals, including both data carriers such bar codes, 2D
431
codes (QR codes and data matrix), NFC and RFID, or image recognition and virtual reality,
and end-users touch points such as websites, web applications or mobile applications.
About digital carriers, it emerges from the interviews that bar codes and 2D codes (QR
codes and data matrix) were recognised by stakeholders as the most popular and probable
to be used for e-labelling of chemicals. On one hand, bar codes have the benefits of being
already on the products’ labels, cost effective to develop and easy to use. On the other hand,
QR codes were also praised for their cost-effectiveness, growing awareness among
consumers and ease of use. Because QR codes are bigger than data matrix, they are easier
to find on the labels and to scan. However, data matrix, being smaller, can be put on labels
with ease and have the benefits of being used for logistics purposes. Whether it is for bar
codes or 2D codes, it has been pointed out that digital carriers must be designed in a way to
direct consumers directly to the information on the digital environment, and not to a home
page, to avoid drop-out.
Regarding the use of wireless IT tools for e-labelling, such as RFID/NFC, despite the fact
that they are popular in some countries (e.g. in Denmark to pay for example), it has mostly
been pointed out that they are expensive for manufacturers and raise concerns for
recyclability.
Finally, the use of more innovative technologies such as image recognition and augmented
reality was also discussed, but were mostly deemed to be not attractive, because chemical
labelling needs to fulfil the purpose of informing consumers (not ‘play with bottles’), and
could be inconvenient in practice for manufacturers since sometimes they do not change the
packaging, but change the formula. Therefore, a code would be preferable rather than
information based on packaging.
Considering end-user touch points, stakeholders from all categories pointed out the growing
development of mobile applications, with the benefits they present for e-labelling: high-use
of smartphones, easy to scan bar codes or QR codes, advantages of for visually impaired
people for example (consumer-friendly presentation, easy to zoom etc.), and possibility to
customise information provided according to consumer’s needs (if specific consumer profile
created in the app). However, with the proliferation of mobile applications in Europe over
the last years, it is also needed to ensure that accurate and scientifically based information
are reaching consumers.
Finally, the question of a database to store the data contained on e-labels was also put
forward by some stakeholders from the industry side, mainly arguing that a centralised
European database with all information for chemicals e-labels would not be the way to go,
because companies would be forced to go with a digital solution for which the structure is
managed externally, and therefore dependent on the people managing it. Moreover, since
all companies are working differently, it could therefore take a long time to establish such
a centralised database.
Stakeholders also put forward additional considerations concerning the use of digital tools
for chemicals’ labelling, such as the need to follow industry standards to encourage
consistent reporting/provision of information in a standard form. In this regard, GS1 is a
non-profit organisation, well-implemented in Europe, which does not provide data carriers
themselves, but a GS1 standard based web enabled syntax, which is applied to, and therefore
works in conjunction with existing data carriers printed on product packaging (EAN/UPC
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barcodes, 2D barcodes, RFID/NFC, digital watermarks…). Furthermore, industry
representatives argued that they should be free to choose which digital solutions they want
to use (option approach). Indeed, e-labelling solutions are evolving quickly, new tools are
continuously being designed, and it is therefore essential to remain flexible. If now,
barcodes and QR codes are the most commonly used ones, in the future it could very well
be NFC, RFID, watermarks (companies are creative and continuously find new ways to use
IT tools). Moreover, some companies are more interested to go in this direction than others,
and therefore the solution needs both direction and flexibility to accommodate them all. To
this regard, a good e-labelling solution would not focus on the technology being used, but
on a list of information that should be provided with this tool (meeting the requirements of
informing the customer properly).
The perceived readiness of consumers to use digital tools to access information on chemicals
was very heterogeneous among stakeholders. The majority of stakeholders from the industry
argued that consumers seem ready now to use IT tools to access information on a digital
environment. To this regard, they pointed out the high awareness of QR codes (especially
since the COVID-19 crisis and the increase in their use in day-to-day activities to limit
physical contact). This claim has been supported by a couple of stakeholders from consumer
associations, also highlighting the role of the COVID-19 crisis in speeding up the process
of the transition to digital tools, as well as the popularity of e-labels in other sectors
(cosmetics, food and beverages).
However, several stakeholders from all categories have argued that consumers were not
ready to shift their habits and use IT tools in their day-to-day lives when it comes to buying
and using chemical products. First of all, they have pointed out that consumers’ readiness
can vary widely depending on age groups (young people being more ready than older
consumers), on country, education, and training. Moreover, several other issues have been
highlighted, such as the lack of internet coverage in some geographical areas, the fact that
not every consumer owns a smartphone or has an easy access to internet at home, as well as
the need to educate consumers at national level about the possibilities to access information
digitally and benefit from the presence of e-labels. Ultimately, in order to avoid inequalities
between consumers regarding access to information, these stakeholders argued that only
complementary information could be provided on e-labels (keeping therefore all essential
information on hazard and safety on physical labels), and that strong backup solutions for
more vulnerable consumers should be developed (e.g. scanning devices to access digital
information in shops).
Benefits and drawbacks of e-labelling
Considering all the points discussed above, stakeholders were asked to provide their views
on what information could be included on an e-label, and what information should remain
on the chemicals’ packaging. In this regard, it must firstly be noted that a couple of
stakeholders (1 business association and 1 consumer association) argued that all information
provided now on chemicals’ labels (according to CLP Regulation) are necessary and should
not be removed. Rather, it is the form that could be simplified and improved in order to
better convey the information and improve their understanding.
Considering what should remain on the physical label, stakeholders from all categories
agreed that the most important is to have information needed to make an informed choice
to buy the product, as well as to use the product safely and efficiently. In other words, it is
433
essential to have the right information at every stage: information about the function of the
product when buying, then about the risks and risks management measures before using (as
well as how to use).
Then, there were several suggestions coming from stakeholders of the business sectors, to
move some information only to the e-label in order to simplify and reduce the overload
character of the physical label, including:
 To move the full ingredient list online, with only some categories of ingredients to
be provided on pack (e.g. allergens, sensitisers). For detergents, the additional
information required by Detergents Regulation (e.g. full lists of preservatives,
anionic surfactants) could be moved online, because if they are classified as
sensitisers under the CLP Regulation, they would be already mentioned.
 To move some of the P-statements online, when they duplicate the information given
by the H-statements, because they are sometimes displayed with long sentences in
small font which are not easy to comprehend.
 To move detailed information related to product use (e.g. detailed dosage
instructions, while keeping a simplified version on pack), since they are looked at
only after purchase and therefore with an easier access to online information than in
a store).
Furthermore, it was argued that e-labelling must bring added value to consumers rather than
just putting information online because there is not enough space on pack. E-labelling
should be used to bring more information to consumers, such as:
Information customised to consumer needs (e.g. for people with allergies very interested in
function of ingredients, with personalised profiles on a mobile application);
Detailed instructions on product use, especially for products with small packaging. For
example, for certain use instructions (e.g. glues), the explanations on correct use have to be
a bit broader. Short description on the mode of use (on the physical label) and then a longer
description on the internet (additional use);
Information on product sustainability or sustainable use and package recycling: additional
information to be provided online, because these issues are complex and multi-factorial and
need space to be explained properly;
the list of ingredients (as mandatory), but with additional information and explanations, for
example with toxicological information explaining why some precautionary statements are
there, of with explanations on voluntary certifications provided on the physical labels.
However, business representatives also underlined some pitfalls of e-labelling. Firstly, all
information going on a digital environment would have to be based on scientific research,
and not be too simplified. Secondly, there is also a risk of putting too much information
online, which leads to labelling overload and unreadability for consumers. E-labelling
should be consumer-friendly.
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To summarise, there are several benefits for the industry. Firstly, they would avoid frequent
reprinting of labels due to carrying out less changes of the physical label by adapting to
regulatory changes. Secondly, the use of e-labels to improve consumers’ understanding
about the safe and appropriate use of products, including the opportunities for digital tools
to provide better explanations (video, animation…), would enable manufacturers to
customise the access to information, and to improve accessibility to all consumers (e.g.
those blind or with low vision). To sum it up, digital labelling should not just be seen as
replication of on pack labelling but instead as an improvement that would allow for
intelligent use of the data that is made available: an online repetition of this information
would also likely be ignored while there is an opportunity to improve hazard and safety
communication for consumers.
On the other hand, stakeholder representatives of consumer associations and national
authorities mainly emphasised the idea that e-labels must feature additional information
complementing the physical label, in other words that it should give extra-information, in
addition to the essential elements currently provided on pack. Examples of ways to use e-
labels to bring added value to consumers given by these stakeholders were the following:
To customise information according to consumers’ needs: if a consumer is allergic to some
ingredients, they can put it on their profile, and then, when scanning products, this
information is specifically highlighted;
To provide information already on the physical label also online, in order to allow for better
readability (bigger letters, possibility to zoom in etc.);
To support the same information of the label but presented in a more consumer-friendly
way;
To have complementary information for interested people who want to know more
(information that is not on the label), such as complementary information about the
ingredients’ purpose in the products, environmental impact of the product etc.
Overall, for consumer associations, digital tools can be useful to improve the
communication of hazard and safety information to consumers. However, as a first step
label elements should not shift from physical to digital, but rather work at least until digital
means demonstrate to be trustable and effective. In other words, the first step of e-labels
should be to support the physical label, and once this step is solid, it can maybe go further
(gradual approach).
Behavioural experiment
Overall, the behavioural experiment shows that the Status Quo and Simplified Label with
QR-code perform better than the No Label Baseline w.r.t. labelling understanding.
Furthermore, the Status Quo and Simplified Label perform equally well. Although, it must
be noted that average understanding of labels is generally not good. Subjective risk
interpretation of the Status Quo and Simplified Label is in line with the actual dangers of
products. Furthermore, subjective ratings of understandability and ease to find of label
elements are not different between the Status Quo and Simplified Label.
The full analysis of the results by research questions can be found in Annex 3.
435
Public Consultation - Simplification and digitalisation of labels on chemicals
The analysis of the answers provided to the public consultation show that, when asked if
they usually understand the information provided on the label of a chemical product, over
two-thirds of stakeholders answered “Yes” or “Yes to some extent” (115/141 of
stakeholders representing the private sector, and 38/53 of stakeholders representing
consumers), showing a relative good understanding of the current chemical labels. The OPC
also focussed on products falling under the Detergents Regulation. To the question
regarding the understandability of the labels on detergent products, a large majority of
stakeholders replied positively (97/129 of stakeholders representing the private sector and
36/50 stakeholders representing consumers).
436
Figure 85: Do you usually understand the information provided on the label of a:
Source: Open public consultation for the Impact Assessment Study on the simplification of the labelling requirements for
chemicals and the use of e-labelling
More specifically, the understanding of information on chemical labels can be broken down
into different categories of information.
Regarding the chemical products, first of all, the majority of stakeholders from both
categories estimate that the information on chemical label properly inform them about:
the dangers or risks of the product (89/141 stakeholders representing the private sector and
39/53 of stakeholders representing consumers answered “yes” or “yes to some extent”);
safe use of the product (81/141 stakeholders representing the private sector and 34/53 of
stakeholders representing consumers answered “yes” or “yes to some extent”);
incentives to take preventive measures (75/141 stakeholders representing the private sector
and 29/53 of stakeholders representing consumers).
However, a majority of stakeholders answered either ‘not always’ or ‘not at all’ to whether
information on chemical labels help them select less hazardous products (70/141
stakeholders representing the private sector and 42/53 stakeholders representing
consumers), and to whether it would prevent them from using the product (81/141
stakeholders representing the private sector and 40/53 stakeholders representing
consumers), suggesting room for improvements in the communication of these information.
To the question of whether they are currently accessing any product information via IT
solutions or digital tools, the majority of stakeholders across all stakeholder groups gave a
positive answer (90/141 of stakeholders representing the private sector, and 30/53 of
stakeholders representing consumers), showing an apparent readiness and interest of
respondents to e-labelling of chemical products.
This conclusion can be moderated by the answers provided to the following question, when
ask how they would evaluate if some information was removed from on-pack label and
14%
12%
28%
22%
55%
63%
0% 25% 50% 75% 100%
Detergent
Chemical product such as a glue or paint
I do not use such products Not at all Some of it Yes, to some extent Yes
437
could be obtained via digital tools, views are mixed among stakeholder groups. On one
hand, over two-thirds of stakeholders representing the industry (98/141) evaluate it either
‘very positively’ or ‘moderately positively’. On the other hand, views are mixed among
stakeholders representing consumers, with 24 consumers answering either ‘very positively’
or ‘moderately positively’, 25 consumers answering either ‘moderately negatively’ or ‘very
negatively’ and 3 consumers answering ‘neither positively nor negatively’. These findings
can indicate the need to pay specific attention to which information are removed from on-
pack label and accessible via digital tools in order to not lower consumer protection.
To this regard, respondents were asked to evaluate to what extent different kind of
information could be removed from the on-pack label of a chemical product and be
transferred to a digital IT solutions.
On one hand, some categories of information were assessed as necessary to remain on pack,
such as:
 pictograms showing the risk of the product (45/69 stakeholders representing the
private sector, and 29/40 stakeholders representing consumers);
 hazard statements or signal words (43/69 of stakeholders representing the private
sector and 25/42 stakeholders representing consumers);
 identification code for poison centers (43/69 stakeholders representing the private
sector and 22/42 of stakeholders representing consumers).
On the other hand, mixed views were given concerning precautionary statements on how to
store, dispose, prevent accidents etc., the majority of stakeholders representing the private
sector indicated the need to keep basic information on pack and provide more detailed online
(35/69), which was agreed by a third of stakeholders representing consumers (17/42), while
13/42 of stakeholders representing consumers expressed the need to keep it on pack, agreed
by 18/69 of stakeholders from the private sector.
Finally, the majority of stakeholders from both categories provided that information on the
name of chemicals causing the hazard could be moved online, either fully (19/67
stakeholders representing the private sector, and 16/42 stakeholders representing
consumers) or with a combination of basic information being kept on pack and more details
provided online (31/67 stakeholders representing the private sector, and 11/42 stakeholders
representing consumers).
Overall, respondents believe that the most effective method to increase the communication
of information on labels of chemicals is by simplifying the text on labels, having less
information on the on-pack label and instead of providing full details via digital labels, and
by using more pictograms or graphic symbols instead of text. In addition, answers given by
consumer representatives show that reducing the number of additional languages on labels
would be most effective to improve the communication of information.
The majority of the respondents (124 out of 174) have currently accessed product
information via IT solutions or digital tools. More specifically, around 78% of respondents
from the industry answered positively to this question , and 62% of respondents representing
consumers.
438
The majority of the respondents look for product information online (for any product) daily
or weekly . Only two respondents look for product information online (for any product)
once a year or less. This finding can be mitigated when looking specifically at answers given
by respondents representing consumers. Indeed, about a third of those look for product
information online only a few times a year.
The most popular choices for the products to use to access the labelling information via IT
solutions were smartphones, laptops, tablets, and desktop computers . The analysis of
answers given by consumer representatives also found the same most popular choices within
this stakeholder group. Regarding touch-end technologies, close to two-thirds of the
respondents would prefer to use QR codes and website address to access the information
online, while around 13% of the respondents do not have a preference for the digital solution
as long as it would work with their preferred device. The analysis of answers given by
consumer representatives also found the same most popular digital solutions within this
stakeholder group.
It must however be noted that the majority of the stakeholders also assessed that the biggest
challenges of presenting some label information via digital labels would be the difficulty to
access information (e.g. poor internet connection, lack of electricity), the potential
differences between the information displayed on the on-pack label and via digital labels
(e.g. due to updates, inconsistencies), and, and creating inequalities for certain population
groups.
Concerning detergents labels only, the majority of the respondents believe that the name of
the product should remain on the on-pack label , while for use instructions, the majority of
the respondent indicated that basic information should be kept on the on-pack label and
more details could be provided via a digital label . Similarly, the majority of the respondents
stated that basic information on special precautions, where required, should be kept on pack
while the details should be moved to a digital label.
In regards to the other parts of the information, the respondents had different views on what
kind of information should remain on the on-pack label, should be kept on the on-pack label
and more details provided via a digital label, or transferred to a digital label completely. For
none of the items there was a majority to move all information to a digital label though for
the list of ingredients this group was particular large. The full overview of the responses to
this question is provided in the table below.
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Table 144: Overview of responses
This finding needs to be mitigated by the answers given specifically by consumer
representatives only, less inclined to move information online. Indeed, within this
stakeholder group, the majority of respondents indicated that all information should remain
on pack for the following categories of information: name of the product , instructions for
use , dosage recommendations , nominal quantity of mixtures , and special precautions .
Finally, consumer representatives had different views on whether to keep on pack, provide
basic information on pack and more details digitally, or completely move to a digital label
the following information: address and telephone number of the manufacturer and list of
ingredients.
Around half of the stakeholders believe that the information from the on-pack label of a
detergent should be moved to the digital label for the following ingredients: Enzymes;
Aliphatic hydrocarbons; Polycarboxylates; Soap; Zeolites; NTA and its salts; EDTA and its
salts.
In regards to the other ingredients, the respondents had different views on what kind of
information should remain on the on-pack label, should be kept on the on-pack label and
more details provided via a digital label, or transferred to a digital label completely. The full
overview of the responses to this question is provided in the table below.
68%
44%
39%
47%
47%
25%
40%
30%
36%
53%
42%
32%
30%
48%
2%
20%
8%
11%
21%
45%
13%
0% 25% 50% 75% 100%
Name of the product
Address and telephone number of the…
Instructions for use
Dosage recommendations
Nominal quantity of the mixture
List of ingredients
Special precautions, where required
All information should remain on the on-pack label
Basic information should be kept on the on-pack label and more details provided via a
digital label
Information should move to a digital label
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Table 145: Overview of responses
However, the analysis of answers given by citizens and consumer organisations indicates
less willingness to move information to a digital label. No categories of information
received a majority of answers to move information online. The only consensus expressed
within this stakeholder category is the need to keep allergenic fragrances on pack.
Online survey for professionals and industry users
In total, the survey has collected responses from 206 stakeholders from four countries
(France, Germany, Greece, and Romania) and three sectors (construction, hotels &
restaurants, and manufacturing). More than half of the survey respondents3
were from micro
& small companies (less than 49 employees), around one-quarter4
were from medium size
companies (between 50 and 249 employees), and the remaining respondents5
represented
large companies (more than 250 employees).
80% of the respondents (164 out of 206) have answered that the companies they represent
are involved in preparing the definitions of the usage guidelines of chemical products used
3
114 out of 206.
4
54 out of 206.
5
36 out of 206.
26%
22%
25%
29%
19%
19%
24%
18%
17%
19%
26%
22%
27%
25%
22%
23%
20%
22%
27%
48%
28%
30%
41%
40%
30%
28%
28%
28%
32%
27%
28%
28%
28%
28%
29%
34%
31%
39%
36%
35%
46%
48%
34%
31%
51%
53%
49%
54%
52%
54%
47%
50%
45%
47%
50%
43%
49%
39%
37%
17%
0% 25% 50% 75% 100%
Phosphates and phosphonates
Surfactants
Oxygen based bleaching agents
Chlorine based bleaching agents
EDTA and its salts
NTA and its salts
Phenols
Zeolites
Soap
Polycarboxylates
Paradichlorobenzene
Aliphatic hydrocarbons
Aromatic hydrocarbons
Halogenated hydrocarbons
Enzymes
Disinfectants
Optical brighteners
Perfumes
Preservatives
Allergenic fragrances
All information should remain on the on-pack label
Basic information should be kept on the on-pack label and more details provided via a digital label
Information should move to a digital label
441
by workers. In addition, around one third of the respondents (136 out of 204) mentioned
that have received training on chemical products or substances, e.g. on hazards or
precautions of safely using these products.
When asked to indicate the three most-used products at work, respondents have identified
cleaning detergents6
as the most often used products at work followed by paints or lacquers7
,
and glues8
.
Figure 86: Could you please indicate the 3 mostly used products at work? (multiple choices question)
When asked to identify the time when do they usually read the safety information on a label
of a chemical product, the majority of the respondents answered that they typically read the
safety information on a label either before they use the product for the first time9
or before
they purchase the product10
.
6
116 out of 417 total choices.
7
81 out of 417 total choices.
8
80 out of 417 total choices.
9
121 out of 334 total choices.
10
85 out of 334 total choices.
4%
14%
16%
19%
19%
28%
0% 5% 10% 15% 20% 25% 30%
Other chemical products
Sealants or fillers (any type – for indoor or
outdoor)
Laundry detergents (any type - powder,
liquid or capsules)
Glues (any type - glue bottle or superglue)
Paints or lacquers (any type – for walls,
wood or other surfaces)
Cleaning detergents (any type – bathroom
cleaner, floor cleaner, cleaning sprays)
442
Figure 87: When do you usually read the safety information on a label of a chemical product? (multiple
choices question)
In terms of rating the importance of certain pieces of information concerning the packaging
of the afore mentioned products, the respondents have rated the signal words11
(i.e.,
“Warning” or “Danger”) and instructions for use12
as the most important elements of
information on the package of the product, whilst marketing information13
seems to be of
the least importance to the respondents. According to the results from the survey, in general,
having all the pieces of information seems to be most essential to laundry detergents14
, while
having all of the pieces of information on the package present in the glues15
seem to be the
least essential overall. More detailed results concerning the importance of having certain
pieces of information in the different categories of chemical products is available in the
table below.
11
Across the five products, respondents have rated the importance of this piece of information as “Absolutely
Essential” or “Very Important” 350 out of 400 times.
12
Across the five products, respondents have rated the importance of this piece of information as “Absolutely
Essential” or “Very Important” 349 out of 401 times.
13
Across the five products, respondents have rated the importance of this piece of information as “Absolutely
Essential” or “Very Important” 175 out of 397 times.
14
Across the 14 pieces of information, respondents have rated the importance of the pieces of information to
this product as “Absolutely Essential” or “Very Important” 761 out of 934 times.
15
Across the 14 pieces of information, respondents have rated the importance of the pieces of information to
this product as “Absolutely Essential” or “Very Important” 795 out of 1085 times.
6%
16%
17%
25%
36%
0% 5% 10% 15% 20% 25% 30% 35% 40%
When an accident occurs
Every time I use the product
Whenever I have a doubt about how to use
the product correctly
Before I purchase the product
Before I use the product for the first time
443
Table 146: In general, on the packaging of the chemical products mentioned below how important do you rate
having the following pieces of information? 16
Piece of information Laundr
y
deterge
nt
Cleani
ng
deterge
nt
Glue Paint Sealant
or filler
Avera
ge
Signal word, i.e., “Warning” or
“Danger”
93% 90% 86% 85% 82% 87%
Instructions for use 93% 89% 80% 86% 88% 87%
Dosage recommendations 87% 86% 86% 86% 82% 86%
Hazard pictogram 90% 83% 83% 79% 75% 82%
Statements on the products
hazards for human health
environment and physical
hazards
88% 85% 78% 75% 81% 81%
List of ingredients contained in
the product, such as allergens,
preservatives or enzymes
90% 82% 78% 75% 81% 81%
Statements on how to prevent
and minimise adverse effects
when accidentally exposed
88% 84% 77% 81% 74% 81%
Quantity 79% 78% 76% 83% 81% 79%
Statements on the precautions
to be taken on the use, storage
and disposal of the product
85% 80% 78% 79% 74% 79%
Name of the product 80% 76% 75% 81% 81% 79%
Information relevant in case of
intoxication e.g. poison centre
telephone number, UFI-code
etc.
84% 80% 76% 77% 75% 78%
Address and telephone number
of the supplier
64% 76% 63% 72% 72% 69%
Weblink to receive full
ingredients list
75% 74% 62% 55% 70% 67%
Marketing information 47% 41% 37% 44% 56% 45%
Total 81% 79% 74% 76% 77% 77%
16
% of survey respondents who have rated the following piece of information as “Absolutely Essential” or
“Very Important”.
444
Concerning the easiness to read the afore mentioned pieces of information in these products,
respondents to the survey think that name of the product17
is usually the most easy to
understand piece of information of the product, while marketing information18
seems to be
the most difficult piece to understand. According to the respondents, the products that are
most easy to understand concerning the information on the package are laundry detergents19
,
while the most difficult to understand are glues20
. More detailed results concerning the
easiness to understand certain pieces of information in the different categories of chemical
products is available in the table below.
Table 147: From your experience with labels of the products mentioned below, how easy to understand do
you find each piece of information typically included on the packaging? 21
Laundry
detergen
t
Cleaning
detergen
t
Glues Paints Sealants
or fillers
Average
Name of the product 94% 90% 92% 89% 88% 91%
Quantity 91% 85% 82% 80% 88% 85%
Instructions for use 87% 81% 83% 83% 86% 84%
Signal word, i.e., “Warning” or
“Danger”
87% 82% 81% 80% 79% 82%
Dosage recommendations 85% 78% 75% 78% 75% 78%
Address and telephone number of the
supplier
83% 82% 66% 74% 70% 75%
Statements on the products hazards for
human health environment and
physical hazards
79% 76% 71% 74% 74% 75%
Hazard pictogram 85% 72% 70% 71% 72% 74%
Statements on the precautions to be
taken on the use, storage and disposal
of the product
75% 70% 73% 79% 67% 73%
Information relevant in case of
intoxication e.g. poison centre
telephone number, UFI-code etc.
73% 70% 69% 64% 74% 70%
Statements on how to prevent and
minimise adverse effects when
accidentally exposed
76% 68% 62% 75% 67% 69%
Weblink to receive full ingredients list 69% 70% 62% 67% 71% 68%
List of ingredients contained in the
product, such as allergens,
preservatives or enzymes
60% 64% 61% 73% 72% 66%
Marketing information 59% 64% 56% 59% 61% 60%
Total 79% 75% 72% 75% 74% 74%
17
Across the five products, respondents have rated the easiness to understand of this piece of information as
“Very easy to understand” or “Rather easy to understand” 361 out of 399 times.
18
Across the five products, respondents have rated the easiness to understand of this piece of information as
“Very easy to understand” or “Rather easy to understand” 233 out of 388 times.
19
Across the 14 pieces of information, respondents have rated the importance of the pieces of information to
this product as Very easy to understand” or “Rather easy to understand” 729 out of 926 times.
20
Across the 14 pieces of information, respondents have rated the importance of the pieces of information to
this product as Very easy to understand” or “Rather easy to understand” 793 out of 1107 times.
21
% of survey respondents who have rated the following piece of information as “Very easy to understand”
or “Rather easy to understand”.
445
Regarding the respondents’ opinion on the possibility of use of an online electronic label
for chemical products, the majority of the respondents22
view this possibility positively or
very positively.
Moreover, the majority of the respondents think that moving all of the pieces of information
currently available on physical labels to the online electronic labels would not impact
detriment to workers’ safety, with address and telephone number of the supplier23
, and
marketing information24
gaining the highest, and information relevant in case of intoxication
e.g. poison centre telephone number, UFI-code etc., and dosage recommendations gaining
the lowest support by the respondents25
.
Figure 88: In case of use of an online electronic label of the chemical products that your company uses, in
your opinion which piece of information currently on physical labels could be moved without detriment to
workers’ safety?
22
147 out of 206 respondents have selected options “Positively” or “Very positively”.
23
168 out of 204 respondents have selected option “Yes”.
24
157 out of 195 respondents have selected option “Yes”.
25
Option “Yes” have been selected 123 out of 199 times for both pieces of information.
446
Online survey on policy measures (also referred to as ‘options’ in this section)
In total, the survey has collected responses from 81 stakeholders from 22 countries26
.
Because of the significant differences in the number of responses collected from different
type of stakeholders, the answers have been divided by stakeholder category: 14
respondents belonged to member state authorities, and 67 were industry representatives
(industry associations, businesses).
Overall assessment of the Policy Options
Stakeholders were asked to rate their overall preference for the Policy Options of this study
(for the description of the Policy Options, please see chapter 5). A rating of -5 is considered
26
Public authorities: 1 respondent each from Austria, Cyprus, Denmark, Finland, Norway, Poland, Portugal,
Romania, Slovakia; 2 respondents from Slovakia; 3 respondents from Lithuania.
Industry: 1 participant each from Bulgaria, Croatia, Czech Republic, Finland, Lithuania, Slovakia,
Switzerland; 2 participants from the Netherlands, 3 participants each from France and the United Kingdom, 5
participants from United States, 9 participants from Belgium, 10 participants from Spain, and 28 participants
from Germany.
18%
19%
26%
28%
30%
30%
34%
35%
35%
35%
36%
37%
38%
38%
82%
81%
74%
72%
71%
70%
66%
65%
65%
65%
64%
63%
62%
62%
0% 25% 50% 75% 100%
Address and telephone number of the
supplier
Marketing information
Weblink to receive full ingredients list
Statements on the products hazards for
human health environment and physical…
Name of the product
Statements on how to prevent and minimise
adverse effects when accidentally exposed
Statements on the precautions to be taken on
the use, storage and disposal of the product
Quantity
List of ingredients contained in the product,
such as allergens, preservatives or enzymes
Signal word, i.e., “Warning” or “Danger”
Instructions for use
Hazard pictogram
Information relevant in case of intoxication
e.g. poison centre telephone number, UFI-…
Dosage recommendations
No Yes
447
as least favourable, 0 as neutral, and +5 as most favourable. The analysis described in detail
in the paragraphs below consists of the median rates given to the Policy Option by
stakeholders.
Public authority stakeholders generally preferred Policy Options 1, 2, and 3 with no
preference on proposed interventions either on CLP or Detergents Regulation considering
Policy Options 1 and 2, and preference towards the proposed interventions on Detergents
regarding Policy Option 3. Out of all the Policy Options considered, public authority
stakeholders had the most negative opinion about Policy Option 4.
On the other hand, stakeholders from industry expressed their preference towards Policy
Option 4 with a preference for proposed interventions on the Detergents Regulation. In
addition, Policy Options 3 and 5 also received a positive feedback with a preference for the
proposed interventions on the Detergents Regulation under Policy Option 3 and a slight
preference for the proposed interventions on the CLP Regulation under Policy Option 5.
448
Table 148: Stakeholders' opinion on the Policy Options27
Type of
stakeholder
Policy
Option 0
Policy
Option 1
Policy
Option 2
Policy
Option 3
Policy
Option 4
Policy
Option 5
Public
authorities
Overall: 2.5 Overall: 4
CLP: 4
Detergents 4
Overall: 4
Sub-option
2(a): 4
Sub-option
2(b): 4
Overall: 4
CLP: 3
Detergents 4
Overall: -2
CLP: -1
Detergents 2
Overall: 2
CLP: 1
Detergents 1
Industry Overall: -1 Overall: -3.5
CLP: -3
Detergents: -
3
Overall: 1.5
CLP: 3
Detergents 4
Overall: 3
CLP: 2
Detergents 3
Overall: 5
CLP: 4
Detergents 5
Overall: 3
CLP: 3
Detergents
2.5
Impact on the awareness of consumers about safe use of products and label readability
Stakeholders were asked to rate the impact of the Policy Options from very negative (-2) to
very positive (+2)28
. The analysis described in detail in the paragraphs below consists of the
median rates given to the Policy Option by the stakeholders.
Concerning the impact of the policy options on the awareness of consumers about safe use
of products and label readability, public authorities had an overall positive opinion about
Policy Options 1, 2, and 3 (besides neutral opinion the impact from the proposed
interventions on Detergents Regulation). Public authorities had an overall negative opinion
concerning Policy Options 4 and 5.
Industry stakeholders had an overall positive opinion about each Policy Options with the
exception of Policy Option 1, which would have no impact on consumer safety. The
proposed interventions under Policy Option 3 on the Detergents Regulation received the
highest support from industry stakeholders as its impact on consumer safety was estimated
as very positive.
27
Public authorities: 12 respondents for Policy Option 0, 10 respondents for Policy Option 1 overall, and 9
each for CLP and Detergents, 11 respondents for Policy Option 2 overall and Sub-option 2(a), and 12 for Sub-
option 2(b), 11 respondents for all the options under Policy Option 3, 11 respondents for Policy Option 4
overall, and 9 for CLP and Detergents, 11 respondents for Policy Option 4 overall, and 10 for CLP and
Detergents, 11 respondents for Policy Option 4 overall, and 10 for CLP and Detergents.
Industry: 54 respondents for Policy Option 0, 38 respondents for Policy Option 1 overall, and 33 each for CLP
and Detergents, 26 respondents for Policy Option 2 overall, 23 for Sub-option 2(a), and 21 for Sub-option
2(b), 38 respondents for Policy Option 3 overall, and 33 for CLP and Detergence, 31 respondents for Policy
Option 4 overall, and 29 for CLP and Detergents, 30 respondents for Policy Option 4 overall, and 28 for CLP
and Detergents, 30 respondents for Policy Option 4 overall, and 28 for CLP and Detergents.
28
-2 =very negative, -1 = slightly negative, 0 = neutral, +1 = slightly positive, +2 = very positive.
449
Table 149: Impact on consumer safety and label readability29
Type of
stakeholder
Policy Option
1
Policy Option
2
Policy Option
3
Policy Option
4
Policy Option
5
Public
authorities
Overall:
Slightly
positive
Overall:
Slightly
positive
Overall:
Slightly
positive
Overall:
Slightly
negative
Overall:
Slightly
negative
CLP:
Slightly
positive
Detergents
: Neutral
Industry Overall:
Neutral
Overall:
Slightly
positive
Overall:
Slightly
positive
Overall:
Slightly
positive
Overall:
Slightly
positive
CLP:
Slightly
positive
Detergents
: Very
positive
Impact on the well-being of consumers with impairments
In terms of the impact of the Policy Options on the well-being of consumers with the
impairments, public authorities considered Policy Option 1 as the most positive for
consumers who are impaired. In particular, Policy Option 1 was considered to have a very
positive impact on consumer who have cognitive/learning impairments. On the other hand,
public authorities estimate an overall neutral or negative impact from the other Policy
Options with the exception of Policy Option 4 and its impact on visually impaired
consumers.
Industry stakeholders considered Policy Options 3 and 4 as most positive for impaired
consumers. In particular, industry stakeholders estimated a very positive impact under
Policy Option 4 for visually impaired consumers. On the other hand, industry stakeholders
estimate an overall neutral or negative impact from the rest of the Policy Options with an
exception of the positive impact on visually impaired consumers under Policy Options 1
and 5. In addition, none of the options were estimated to have an overall positive impact on
consumers with mobility or physical impairments.
29
Public authorities: 11 respondents for Policy Option 1, 12 respondents for Policy Option, 11 respondents
for all the options under Policy Option 3, 11 respondents for Policy Option 4, 11 respondents for Policy Option
5.
Industry: 41 respondents for Policy Option 1, 26 respondents for Policy Option 2, 36 respondents for Policy
Option 3 overall, and 33 for CLP and Detergence, 29 respondents for Policy Option, 28 respondents for Policy
Option 5.
450
Table 150: Impact on the well-being of consumers with impairments30
Type of
stakeholder
Type of impairment Policy
Option 0
Policy
Option 1
Policy
Option 3
Policy
Option 4
Policy
Option 5
Public
authorities
Vision: 25% 55% 64% 45% 45%
Colour blind: 27% 62% 36% 18% 27%
Cognitive/Learning 36% 70% 27% 18% 27%
Mobility/Physical 18% 64% 31% 27% 27%
Industry Vision: 13% 53% 65% 77% 61%
Colour blind: 12% 29% 56% 50% 37%
Cognitive/Learning 13% 33% 52% 53% 32%
Mobility/Physical 11% 23% 27% 21% 25%
Impact on the awareness of consumers about the effects of dispersion of harmful substances
in the natural environment
Stakeholders were asked to rate the impact of the Policy Options from very negative (-2) to
very positive (+2)31
. The results described in detail in the paragraphs below consist of the
median ratings given to the Policy Option by the stakeholders.
Public authorities consider Policy Options 0, 1, and 2 as having an overall positive impact
on consumer awareness about the effects of dispersion of harmful substances in the natural
environment. Policy Options 4 and 5 are estimated to have a negative impact and Policy
Option 3 is considered to have no impact in this area.
Industry stakeholders consider Policy Options 3 and 4 as having an overall positive impact
on consumer awareness about the effects of dispersion of harmful substances in the natural
30
Public authorities: Policy Option 0, Vision n=3 out of 12; Colour blind – 3 out of 11, Cognitive/Learning
– 4 out of 11, Mobility/Physical 2 out of 11. Policy Option 1, Vision n=6 out of 11; Colour blind – 8 out of
13, Cognitive/Learning – 7 out of 11, Mobility/Physical 7 out of 11, Policy Option 3, Vision n=7 out of 11;
Colour blind – 4 out of 11, Cognitive/Learning – 3 out of 11, Mobility/Physical 4 out of 13, Policy Option 4,
Vision n=5 out of 11; Colour blind – 2 out of 11, Cognitive/Learning – 2 out of 11, Mobility/Physical 3 out
of 11, Policy Option 5, Vision n=5 out of 11; Colour blind – 3 out of 11, Cognitive/Learning – 3 out of 11,
Mobility/Physical 3 out of 11.
Industry: Policy Option 0, Vision n=6 out of 47; Colour blind – 6 out of 49, Cognitive/Learning – 6 out of
48, Mobility/Physical 5 out of 47. Policy Option 1, Vision n=21 out of 40; Colour blind – 12 out of 42,
Cognitive/Learning – 13 out of 39, Mobility/Physical 9 out of 39, Policy Option 3, Vision n=20 out of 31;
Colour blind – 18 out of 32, Cognitive/Learning – 16 out of 31, Mobility/Physical 8 out of 30, Policy Option
4, Vision n=24 out of 31; Colour blind – 15 out of 30, Cognitive/Learning – 15 out of 30, Mobility/Physical
6 out of 28, Policy Option 5, Vision n=17 out of 28; Colour blind – 10 out of 27, Cognitive/Learning – 9 out
of 28, Mobility/Physical 7 out of 28.
31
-2 =very negative, -1 = slightly negative, 0 = neutral, +1 = slightly positive, +2 = very positive.
451
environment, while the remaining Policy Options are estimated to have no impact in this
area.
Table 151: Impact on the awareness of consumers on the effects of dispersion of harmful substances in the
natural environment32
Type of
stakeholder
Policy
Option 0
Policy
Option 1
Policy
Option 2
Policy
Option 3
Policy
Option 4
Policy
Option 5
Public
authorities
Slightly
positive
Slightly
positive
Slightly
positive
Neutral Slightly
negative
Slightly
negative
Industry Neutral Neutral Neutral Slightly
positive
Slightly
positive
Neutral
Coherence with the digitalisation trends of the market
Stakeholders were asked to rate each Policy Option in term of its coherence with the
digitalisation trends in the market. A rating of 0 is considered as the least coherent, 5 as
neutral, and 10 as most coherent. The results described in detail in the paragraphs below
consist of the median ratings given to the Policy Option by the stakeholders.
Public authorities considered Policy Option 1 as the most coherent with the digitalisation
trends in the market. Policy Options 3, 4 and 5 also received overall positive feedback, while
Policy Option 2 was estimated to have no impact on coherence with digitalisation trends in
the market.
Industry stakeholders considered Policy Option 4 as most coherent with digitalisation.
Policy Options 3 and 5 also received overall positive feedback, while Policy Options 1 and
2 were estimated to have negative impact on the coherence with the digitalisation trend.
Table 152: Coherence with the digitalisation of the market33
Type of
stakeholder
Policy
Option 1
Policy
Option 2
Policy
Option 3
Policy
Option 4
Policy
Option 5
Public
authorities
8 5 6.5 7 7.5
Industry 2 1 7 9 7
32
Comparison of median results. Stakeholders were asked to rate the coherence from very negative (-2) to
very positive (+2)
Public authorities. 12 respondents, in total, under Policy Option 0, 12 respondents, in total, under Policy
Option 1, 12 respondents, in total, under Policy Option 2, 13 respondents, in total, under Policy Option 3, 11
respondents, in total, under Policy Option 4, 11 respondents, in total, under Policy Option 5.
Industry. 51 respondents, in total, under Policy Option 0, 41 respondents, in total, under Policy Option 1, 19
respondents, in total, under Policy Option 2, 35 respondents, in total, under Policy Option 3, 28 respondents,
in total, under Policy Option 4, 27 respondents, in total, under Policy Option 5.
33
Public authorities. 12 respondents, in total, under Policy Option 1, 12 respondents, in total, under Policy
Option 2, 12 respondents, in total, under Policy Option 3, 11 respondents, in total, under Policy Option 4, 12
respondents, in total, under Policy Option 5.
Industry. 44 respondents, in total, under Policy Option 1, 29 respondents, in total, under Policy Option 2, 35
respondents, in total, under Policy Option 3, 25 respondents, in total, under Policy Option 4, 27 respondents,
in total, under Policy Option 5.
452
Impact on the competitive position of EU firms with respect to non-EU competitors
Stakeholders were asked to rate the impact of the Policy Options from very negative (-2) to
very positive (+2)34
. The results described in detail in the paragraphs below consist of the
median ratings given to the Policy Option by the stakeholders.
Public authorities consider Policy Option 3 as having an overall positive impact with regards
to the competitive position of EU firms with respect to non-EU competitors. Policy Option
5 is estimated to have a negative impact and Policy Options 2 and 4 are considered to have
no impact in this area.
Industry stakeholders estimate that none of the Policy Options would have any impact on
the competitive position of EU firms with respect to non-EU competitors.
Table 153: Impact to competitive position of EU firms with respect to non-EU competitors35
Type of
stakeholder
Policy
Option 2
Policy
Option 3
Policy
Option 4
Policy
Option 5
Public
authorities
Neutral Slightly
positive
Neutral Slightly
negative
Industry Neutral Neutral Neutral Neutral
Impact on SMEs
Stakeholders were asked to rate the impact of the Policy Options from very negative (-2) to
very positive (+2). The results described in detail in the paragraphs below consist of the
median ratings given to the Policy Option by the stakeholders.
Public authorities consider Policy Options 3, 4 and 5 as having an overall positive impact
on addressing disproportionate costs for SMEs in comparison to larger enterprises, while
Policy Option 2 is considered to have no impact on SMEs in this regard.
Industry stakeholders consider Policy Option 4 as having an overall positive impact on
addressing disproportionate costs for SMEs in comparison to larger enterprises, while
Policy Options 2, 3 and 5 are considered to have no impact on SMEs in this regard.
34
-2 =very negative, -1 = slightly negative, 0 = neutral, +1 = slightly positive, +2 = very positive.
35
Public authorities. 3 respondents each under Policy Options 2, 3, and 4, 1 respondents under Policy Option
5. Note: responses “I don’t know” were not taken into consideration under the analysis here.
Industry. 26 respondents, in total , under Policy Option 2, 16 respondents, in total, under Policy Option 3, 11
respondents, in total, under Policy Option 4, 18 respondents, in total, under Policy Option 5. Note: responses
“I don’t know” were not taken into consideration under the analysis here.
453
Table 154: Impact on SMEs36
Type of
stakeholder
Policy
Option 2
Policy
Option 3
Policy
Option 4
Policy
Option 5
Public
authorities
Neutral Slightly
positive
Slightly
positive
Slightly
positive
Industry Neutral Neutral Slightly
positive
Neutral
In terms of the stakeholder perception on the costs-benefits ratio37
under each Policy Option,
public authorities consider Policy Option 2 as the most cost-effective Policy Option, while
Policy Option 3 is estimated to be neutral in this regards, and Policy Options 4 and 5 appear
to bring considerably more costs than benefits regarding the activities of the market
surveillance authorities.
On the other hand, industry stakeholders estimate high benefits and low costs under Policy
Options 4 and 5, while for Policy Option 3, industry stakeholders estimate that the costs
under this option will slightly outweigh the benefits.
36
Public authorities: 6 respondents, in total , under Policy Option 2, 4 respondents, in total, under Policy
Option 3, 4 respondents, in total, under Policy Option 4, 5 respondents, in total, under Policy Option 5. Note:
responses “I don’t know” were not taken into consideration under the analysis here.
Industry. 13 respondents, in total , under Policy Option 2, 16 respondents, in total, under Policy Option 3, 11
respondents, in total, under Policy Option 4, 11 respondents, in total, under Policy Option 5. Note: responses
“I don’t know” were not taken into consideration under the analysis here.
37
Ratio of stakeholders who’ve indicated that cost and benefits under the Policy Option are high or very high.
If the ratio is negative it means stakeholders estimate higher costs than benefits under the option.
454
Table 155: Stakeholders' perception on the cost-benefits ratio under the Policy Options38
Type of
stakeholder
Policy Option 1 Policy Option 2 Policy Option 3 Policy Option 4 Policy Option 5
Public
authorities
Undefined Overall: 27% Overall: 0% Overall: -
14%
Overall: -
16%
Industry Undefined Undefined Overall: -7%
CLP: -7%
Detergent: -
3%
Overall: 14%
CLP: 14%
Detergent:
7%
Overall: 34%
CLP: 35%
Detergent:
11%
38
Public authorities: Under Policy Option 2, 2 out of 12 stakeholders estimate high or very high costs, 5 out
of 12 stakeholders estimate high or very high benefits. Under Policy Option 3, 3 out of 10 stakeholders
estimate high or very high costs, 3 out of 10 stakeholders estimate high or very high benefits. Under Policy
Option 4, 3 out of 11 stakeholders estimate high or very high costs, 1 out of 11 stakeholders estimate high or
very high benefits. Under Policy Option 5, 3 out of 12 stakeholders estimate high or very high costs, 1 out of
12 stakeholders estimate high or very high benefits.
Industry: Under Policy Option 3, overall, 17 out of 26 stakeholders estimate high or very high costs, 19 out
of 32 stakeholders estimate high or very high benefits. Under CLP, 17 out of 26 stakeholders estimate high or
very high costs, 19 out of 32 stakeholders estimate high or very high benefits. Under Detergents Regulation,
8 out of 23 stakeholders estimate high or very high costs, 8 out of 25 stakeholders estimate high or very high
benefits. Under Policy Option 4, overall, 16 out of 24 stakeholders estimate high or very high costs, 21 out
of 26 stakeholders estimate high or very high benefits. Under CLP,16 out of 24 stakeholders estimate high or
very high costs, 21 out of 26 stakeholders estimate high or very high benefits. Under Detergents Regulation,
8 out of 20 stakeholders estimate high or very high costs, 10 out of 21 stakeholders estimate high or very high
benefits. Under Policy Option 5, overall, 9 out of 20 stakeholders estimate high or very high costs, 18 out of
23 stakeholders estimate high or very high benefits. Under CLP,9 out of 21 stakeholders estimate high or very
high costs, 18 out of 23 stakeholders estimate high or very high benefits. Under Detergents Regulation, 5 out
of 18 stakeholders estimate high or very high costs, 7 out of 18 stakeholders estimate high or very high
benefits.