REGULATORY SCRUTINY BOARD OPINION Proposal for a Regulation of the European Parliament and of the Council on detergents and surfactants, amending Regulation (EU) No 2019/1020 and repealing Regulation (EC) No 648/2004

EUROPEAN COMMISSION
Brussels, 16.09.2022
SEC(2023) 170 final
REGULATORY SCRUTINY BOARD OPINION
Proposal for a Regulation of the European Parliament and of the Council
on detergents and surfactants, amending Regulation (EU) No 2019/1020 and repealing
Regulation (EC) No 648/2004
{COM(2023) 217 final}
{SWD(2023) 113 final}
{SWD(2023) 114 final}
{SWD(2023) 115 final}
Offentligt
KOM (2023) 0217 - SEK-dokument
Europaudvalget 2023
________________________________
This opinion concerns a draft impact assessment which may differ from the final version.
Commission européenne, B-1049 Bruxelles - Belgium. Office: BERL 08/010. E-mail: regulatory-scrutiny-board@ec.europa.eu
EUROPEAN COMMISSION
Regulatory Scrutiny Board
Brussels,
RSB
Opinion
Title: Impact assessment / Revision of the Detergents Regulation
Overall opinion: POSITIVE
(A) Policy context
The Detergents Regulation provides for the free movement of detergents and surfactants on
the internal market. It aims to ensure a high level of protection of the environment and
human health and covers both consumer and industrial detergents. The Regulation applies
in all EU Member States and countries of the European Economic Area (i.e. Iceland,
Lichtenstein, Norway). Since its entry into force in 2004, the Regulation has been amended
multiple times to reflect market innovations and safety concerns including in 2008 to align
with the Regulation on classification, labelling and packaging of substances and mixtures.
This initiative aims to revise the Detergents Regulation to reflect new challenges including
new market developments and simplification opportunities. The impact assessment
explores options to cover refill sales as a sustainable new practice and microbial cleaning
products as innovative products. It also posits changes to labelling requirements and
ingredient data sheets by reaping the benefits of digital solutions
(B) Summary of findings
The Board notes the additional information provided in advance of the meeting and
commitment to make changes to the report. The Board gives a positive opinion. The
Board also considers that the report should further improve with respect to the
following aspects:
(1) The report does not sufficiently explain the scope of the initiative for refills and
microbial detergents. The analysis does not provide a sufficient explanation of
what success would look like.
(2) The report lacks clarity on the impacts on SMEs. In particular, it does not
provide a clear description of the evidence of the acceptability of costs to fulfil the
risk management requirements for microbial products.
Ares(2022)6405072 - 16/09/2022
2
(C) What to improve
(1) The report should clarify the scope of the initiative for refills and microbial detergents.
The analysis should better elaborate how serious the problems related to refill sales and
microbial products are, and whether facilitation of refill sales is a primary or secondary
objective. The report should clarify upfront that the overarching aims of the intervention
are safety for citizens and the environment, as well as the level playing field for EU
businesses.
(2) The report should better explain what success would look like. The analysis should
include necessary benchmarks to measure the accomplishment of the objectives. The report
should reflect these in the monitoring and evaluation arrangements, the operational
objectives and the monitoring indicators.
(3) The report should better explain the impacts of each option on SMEs. Given that most
of the producers of microbial detergents are SMEs, the report should analyse the impacts
on different categories of them, especially microenterprises. The report should better
explain why and how the SMEs would ‘strongly benefit’ from digital labelling.
(4) The report needs better reasoning behind the ‘acceptability’ of EUR 200,000 costs for
SMEs to fulfil the risk management requirements for microbial products. It should further
detail what this cost includes and why it may vary from one company to another. It should
better present the evidence to support this assumption and clarify the uncertainty of the
calculations.
The Board notes the estimated costs and benefits of the preferred option(s) in this
initiative, as summarised in the attached quantification tables.
Some more technical comments have been sent directly to the author DG.
(D) Conclusion
The DG may proceed with the initiative.
If there are any changes in the choice or design of the preferred option in the final
version of the report, the DG may need to further adjust the attached quantification
tables to reflect this.
Full title Proposal for a regulation of the European Parliament and the
Council Amending Regulation (EC) No 648/2004 of the
European Parliament and the Council of 31 March 2004 on
detergents
Reference number PLAN/2021/10270
Submitted to RSB on 20 July 2022
Date of RSB meeting Written procedure
3
ANNEX – Quantification tables extracted from the draft impact assessment report
The following tables contain information on the costs and benefits of the initiative on
which the Board has given its opinion, as presented above.
If the draft report has been revised in line with the Board’s recommendations, the content
of these tables may be different from those in the final version of the impact assessment
report, as published by the Commission.
I. Overview of Benefits (total for all provisions) – Preferred Option
Description Amount Comments
Direct benefits
Reduced
administrative burden
for manufacturers of
detergents due to
elimination of
duplications, digital
labelling and
abolishment of
ingredient data sheets
€7 million - abolishment of ingredient
data sheets for hazardous detergents
Savings due to elimination of
duplications in the labelling
requirements and digital labelling - non
quantifiable.
Digital labels are easier to update and
less costly compared to physical labels.
Moving certain information to the
digital labels allows for less relabelling.
The introduction of digital
labelling is on a voluntary basis
and manufacturers of detergents
are already required to maintain a
website with a full ingredient list.
Users enjoying greater
ease of use and
increased awareness of
key information (e.g.
ingredients, safety
information).
Non-monetary benefit Evidence from the consultations
highlights that increased
awareness about product
information on labels and more
informed decision-making is
likely to reduce risks to health and
safety.
Public authorities also benefit
from simplified labels and digital
labels render enforcement easier
(information online will be easy to
navigate and searchable).
Improved functioning
of the internal market
Non-monetary benefit Legal clarity and certainty for
microbial cleaning products and
refill sales. Harmonised
requirements for microbial
cleaning products and facilitation
of refill sales also through
(optional) digital labelling.
Reduced risks to health
and safety of users
Non-monetary benefit Improved label readability would
lead to increased consumer safety.
Consumers receive complete
information on refilled detergents
and are allowed to make informed
4
choices for their health and the
environment. Ingredient data
sheet for non-hazardous
detergents is maintained.
Optimised protection
of the environment
Non-monetary benefit Simplified dosage instructions and
detailed information on e-labels
ensures proper use and prevents
overdosing. Consumers receive
information on use of refilled
detergents and microbial cleaning
products.
Indirect benefits
Reduced disposal of
plastic waste (refill
sales)
Impact not quantified; the baseline
savings estimated at €3.3 million
The facilitation of refill sales
would lead to a reduction of
disposed plastic waste and
consequent cost savings. These
savings could increase based on
the expected growth of refill sales.
Potential reduction in
the disposal of unused
labels due to digital
labelling
Not quantifiable Digital labels are easier to update
and less costly compared to
physical labels. Moving certain
information to the digital labels
allows for less relabelling.
Administrative cost savings related to the ‘one in, one out’ approach*
Annual direct
administrative savings
- abolishment of
ingredient data sheets
for hazardous
detergents
€7 million
Potential additional
administrative costs
savings due to
voluntary digitalisation
of labels
Not quantifiable The benefits would stem from the
digitalisation of some information
compared with the current
physical-only labelling
requirements.
Given the voluntary nature of the
preferred option, no costs would
be imposed on businesses.
Businesses would only provide
digital labelling if they perceive
the potential to enjoy reduced
costs (or if they perceived
sufficient other business benefits
to justify any cost increase).
Cost savings would arise through
reducing the frequency of
disposing of and redesigning
5
physical labels. There would also
be economies of scale in that more
languages could fit on physical
labels. All types of firms (SMEs
and large enterprises) would be
able to benefit from digitalisation.
II. Overview of costs – Preferred option
Citizens/Consumers Businesses Administrations
One-off Recurrent One-off Recurrent One-off Recurrent
Action
(a)
Direct
adjustment
costs
Not
relevant
Not relevant
€72,000
Total
familiarisati
on costs
(€25.7/h, 4
man hours
per
company)
€200.000*
(tests for
microbial
cleaning
products)
Not
relevant
Not
relevant
Direct
administrative
costs
Not
relevant
Not relevant
voluntary
digital
labelling -
minor costs
for updating
websites
Not relevant
Not
relevant
Not
relevant
Direct
regulatory fees
and charges
Not
relevant
Not relevant Not relevant Not relevant
Not
relevant
Not
relevant
Direct
enforcement
costs
Not
relevant
Not relevant Not relevant Not relevant
Not
relevant
Possible
slight
increase of
enforcemen
t costs – not
quantifiable
Indirect costs Not
relevant
Not relevant Not relevant Not relevant Not
relevant
Not
relevant
Costs related to the ‘one in, one out’ approach
Total Direct
adjustment
Not
relevant
Not relevant Not relevant Not relevant
6
costs
Indirect
adjustment
costs
Not
relevant
Not relevant Not relevant Not relevant
Administrative
costs (for
offsetting)
Not
relevant
Not relevant Not relevant Not relevant
* It should be noted that this an upper bound estimate, taking into account the highest
number of batches reported by stakeholders during the interviews. The costs related to
proving the lack of antibiotic resistance can range from €0 (in cases where the relevant
data is already available in EUCAST1
) to €335 per strain of microorganism used (in cases
where this needs
1
European Committee on Antimicrobial Susceptibility Testing
Electronically signed on 16/09/2022 14:21 (UTC+02) in accordance with Article 11 of Commission Decision (EU) 2021/2121