COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT REPORT Accompanying the document Proposal for a Directive of the European Parliament and of the Council amending Directive 2000/60/EC establishing a framework for Community action in the field of water policy, Directive 2006/118/EC on the protection of groundwater against pollution and deterioration and Directive 2008/105/EC on environmental quality standards in the field of water policy

EN EN
EUROPEAN
COMMISSION
Brussels, 26.10.2022
SWD(2022) 540 final
COMMISSION STAFF WORKING DOCUMENT
IMPACT ASSESSMENT REPORT
Accompanying the document
Proposal for a Directive of the European Parliament and of the Council
amending Directive 2000/60/EC establishing a framework for Community action in the
field of water policy, Directive 2006/118/EC on the protection of groundwater against
pollution and deterioration and Directive 2008/105/EC on environmental quality
standards in the field of water policy
{COM(2022) 540 final} - {SEC(2022) 540 final} - {SWD(2022) 543 final}
Offentligt
KOM (2022) 0540 - SWD-dokument
Europaudvalget 2022
1
Contents
1 INTRODUCTION: POLITICAL AND LEGAL CONTEXT...................................10
2 PROBLEM DEFINITION.........................................................................................13
2.1 What are the problems? ...................................................................................14
2.2 What are the problem drivers?.........................................................................18
2.3 How likely is the problem to persist? ..............................................................21
3 WHY SHOULD THE EU ACT?...............................................................................29
3.1 Legal basis .......................................................................................................29
3.2 Subsidiarity: Necessity of EU action ...............................................................30
3.3 Subsidiarity: Added value of EU action ..........................................................31
4 OBJECTIVES: WHAT IS TO BE ACHIEVED?......................................................32
4.1 General objectives............................................................................................32
4.2 Specific objectives ...........................................................................................32
5 WHAT ARE THE AVAILABLE POLICY OPTIONS?...........................................32
5.1 Methodology to select substances and set the quality standards .....................33
5.2 Description of the policy options.....................................................................37
5.3 Options discarded at an early stage..................................................................42
6 WHAT ARE THE IMPACTS OF THE POLICY OPTIONS AND WHO WILL
BE AFFECTED? .......................................................................................................42
6.1 Impact assessment methodology......................................................................43
6.2 Surface water – impacts of policy options.......................................................47
6.3 Groundwater – impacts of policy options........................................................57
6.4 Monitoring, reporting and administrative streamlining – impacts of options .61
6.5 Administrative burden .....................................................................................68
6.6 Note on impacts for individual MS..................................................................68
7 HOW DO THE OPTIONS COMPARE AND WHAT ARE THE PREFERRED
OPTIONS?.................................................................................................................69
7.1 Surface water ...................................................................................................70
7.2 Groundwater ....................................................................................................78
7.3 Monitoring, reporting and administrative streamlining options ......................82
8 PREFERRED POLICY PACKAGE .........................................................................84
8.1 Preferred options summary..............................................................................84
8.2 Overall magnitude of impacts..........................................................................86
8.3 One In, One Out...............................................................................................87
8.4 REFIT ..............................................................................................................88
9 HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED?........89
9.1 Indicators of success ........................................................................................89
9.2 Monitoring and evaluation under the existing EU water quality legislation ...89
2
9.3 Joint monitoring and evaluation.......................................................................90
ANNEX 1: PROCEDURAL INFORMATION.................................................................92
ANNEX 2: STAKEHOLDER CONSULTATION (SYNOPSIS REPORT).....................96
ANNEX 3: WHO IS AFFECTED AND HOW? PRACTICAL IMPLICATIONS OF
THE INITIATIVE ...................................................................................................116
ANNEX 4: ANALYTICAL METHODS USED IN PREPARING THE IMPACT
ASSESSMENT........................................................................................................125
ANNEX 5: RELATIONS BETWEEN ONGOING INITIATIVES AND THE
PRESENT INITIATIVE..........................................................................................153
ANNEX 6: TECHNICAL PROCESS FOR THE REVISION OF THE LIST OF
PRIORITY SUBSTANCES AND THEIR EQS IN SURFACE WATER..............159
ANNEX 7: TECHNICAL PROCESS FOR THE REVISION OF THE LISTS OF
POLLUTANTS IN GROUNDWATER ..................................................................164
ANNEX 8: RESULTS OF THE QUALITY STANDARD DERIVATION PROCESS
FOR REVISION OF THE ANNEXES TO THE EQSD AND GWD.....................175
ANNEX 9: DETAILED ASSESSMENT OF IMPACTS PER POLICY OPTION ........188
ANNEX 10: POTENTIAL COSTS OF SELECTED SURFACE WATER AND
GROUNDWATER POLLUTION REDUCTION MEASURES ............................216
ANNEX 11: SURFACE WATER MONITORING DATA ............................................222
ANNEX 12: LITERATURE REFERENCES..................................................................228
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Abbreviations
Term or abbreviations Meaning or definition
AA Annual Average
AC Associated Countries
AgNPs Silver (Ag) nano-particles
AMR Antimicrobial Resistance
BAT Best Available Techniques
BPR Biocidal Products Regulation
BREF Best Available Techniques Reference
BWD Bathing Water Directive
CAS Chemical Abstracts Service
CIRCABC Communication and Information Resource Centre for
Administrations, Businesses and Citizens
CIS Common Implementation Strategy
CJEU Court of Justice of the European Union
CLP EU Regulation on Classification, Labelling and Packaging of
chemical substances and mixtures to the Globally Harmonised
System.
CMR Carcinogenic, Mutagenic and Reprotoxic
DNSH Do No Significant Harm
DSD Dangerous Substances Directive
DSUP Directive on Sustainable Use of Pesticides
DWD Drinking Water Directive
DWS Drinking Water Standard
EBM Effect-Based Methods
EC European Commission
ECA European Court of Auditors
ECHA European Chemicals Agency
EDC Endocrine Disrupting Chemical
EEA European Economic Area/European Environment Agency (Context
specific)
4
Term or abbreviations Meaning or definition
EINECS/EC numbers European Inventory of Existing Commercial Chemical Substances
number/European Community number
E-PRTR European Pollutants Release and Transfer Register
EPR Extended Producer Responsibility
EQS(D) Environmental Quality Standards (Directive)
EU European Union
FC Fitness Check
FD Floods Directive
FTE Full-Time Equivalent
GAC Granulated Activated Carbon (GAC)
GES Generic Exposure Scenarios
GQA General Quality Assessment test for groundwater chemical status
GWAAE Groundwater Associated Aquatic Ecosystems
GWD Groundwater Directive
GWDTE Groundwater Dependent Terrestrial Ecosystems
GWQS Groundwater Quality Standards
GWWL Groundwater Watch List
IA Impact Assessment
IED Industrial Emissions Directive
IPCC Intergovernmental Panel on Climate Change
IPM Integrated Pest Management
IUPAC International Union of Pure and Applied Chemistry
JRC European Commission Joint Research Centre
LFR List Facilitating the 6-yearly Review of GWD Annexes I and II
MAC Maximum Allowable Concentration
MS Member State(s)
MSFD Marine Strategy Framework Directive
NAg Nano-Silver (Ag)
ND Nitrates Directive
NPV Net Present Value
5
Term or abbreviations Meaning or definition
nrMs non-relevant Metabolites (pesticide degradation products)
OECD Organisation for Economic Cooperation and Development
OPC Open/Online Public Consultation
PACT Public Activities Coordination Tool
PAH Polyaromatic Hydrocarbon
PBDE Polybrominated Diphenyl Ethers
PBT Persistent, Bioaccumulative and Toxic
PC Participating Countries
PCP Personal Care Products
PFAS Perfluoroalkyl and Polyfluoroalkyl Substances
PFCA Perfluorinated Carboxylic Acids
PFOA Perfluorooctanoic Acid
PFOS Perfluorooctane Sulfonate
PFOSA Perfluorooctanesulfonamide
PHS Priority Hazardous Substance
PMT Persistent, Mobile and Toxic
PNEC Predicted No Effect Concentration
PoMs Programmes of Measures
POP Persistent Organic Pollutant
PRO Producer Responsibility Organisations
PS Priority Substance
RBMP River Basin Management Plan
RBSP River Basin Specific Pollutant
REACH Registration, Evaluation, Authorisation and Restriction of Chemicals
RPF Relative Potency Factor
RoHS Restriction of Hazardous Substances
SCCS Scientific Committee on Consumer Safety
6
Term or abbreviations Meaning or definition
SCHEER Scientific Committee on Health, Environmental and Emerging Risks
SDG Sustainable Development Goals
SSD Sewage Sludge Directive
SUPD Single-Use Plastics Directive
SVHC Substance of Very High Concern
SWD Staff Working Document
TFEU Treaty on the Functioning of the European Union
ToR Terms of Reference
TV Threshold Value
TWI Tolerable Weekly Intake
vPvM Very Persistent and Very Mobile
UWWTD Urban Waste Water Treatment Directive
WB Water Body
WFD Water Framework Directive
WG Working Group
WG GW Working Group for Groundwater
WL Watch List
WWTP Wastewater Treatment Plant
ZPAP Zero Pollution Action Plan
Glossary
Term or acronym Meaning or definition
Antimicrobial Resistance (AMR) AMR occurs when microbes (e.g. fungi and bacteria) transform over
time and no longer respond to antimicrobial substances, in particular
pharmaceuticals but also biocidal products and certain metals (e.g.
silver). The main drivers of the development of drug-resistant
pathogens are misuse and overuse of anti-microbials e.g. antibiotics,
antivirals, antifungals and antiparasitics. AMR has been declared as
one of the top 10 global public health threats facing humanity by the
World Health Organization. (1)
Contaminants of emerging concern According to the Organisation for Economic Co-operation and
Development (OECD) “Contaminants of emerging concern” (CECs)
comprise a vast array of contaminants that have only recently
appeared in water, or that are of recent concern because they have
7
Term or acronym Meaning or definition
been detected at concentrations significantly higher than expected, or
their risk to human and environmental health may not be fully
understood. Examples include pharmaceuticals, industrial and
household chemicals, personal care products, pesticides,
manufactured nanomaterials, and their transformation products’. (2)
Do No Significant Harm (DNSH) In the area of this initiative an activity is considered to be in line with
the ‘do no significant harm’ to the sustainable use and protection of
water and marine resources if it contributes to achieving and
maintaining the good status or the good ecological potential of bodies
of water, including surface water and groundwater, or to the good
environmental status of marine waters.
Effect-Based Methods (EBM) EBM are methods for detecting the presence of substances indirectly,
i.e. without conducting conventional chemical analysis. They use
biological test systems, which can be inside or outside a laboratory,
and capture the presence of chemicals having the same biological
effect, for example estrogenic activity or inhibition of photosynthesis.
Fitness Check of EU Water Law Evaluation of WFD, Environmental Quality Standards Directive,
Groundwater Directive and Floods Directive, published on 10
December 2019 (SWD(2019)439 final).
Groundwater Water which is below the surface of the ground in the saturation zone
and in direct contact with the ground or subsoil.
Microplastics Generally, microplastics are referred to as plastic fragments having at
least one of their dimensions between 0.1 μm−5 mm in size. Note:
according to the European Chemicals Agency (ECHA), ‘the term
“micro-plastic” is not consistently defined, but is typically considered
to refer to small, usually microscopic, solid particles consisting of a
synthetic polymer. They are associated with long-term persistence in
the environment, if released, as they are very resistant to
(bio)degradation.’ The smallest particle size fractions are usually
referred to as nanoplastics (3)
Micro-pollutants Micro-pollutants are defined as synthetic or natural compounds
released from point and nonpoint resources and which end up in the
aquatic environments at low concentration (4), i.e. pollutants, which
exist in very small traces in water (5). Most micro-pollutants are
considered as “Contaminants of emerging concern” (see above).
Nanoplastics Generally, nanoplastics are referred to as plastic fragments with at
least one of their dimensions from 1 to 100 nm. Nanoplastic particles
often present a colloidal behavior and are often unintentionally
produced (i.e. from. the wear-and-tear, abrasion, degradation and the
manufacturing of the plastic objects).
Pesticides Pesticides can be described (with certain minor exceptions) as any
substances or mixtures of substances intended for preventing,
destroying, repelling, or mitigating any pest; any substances or
mixtures of substances intended for use as a plant regulator, defoliant,
or desiccant; any nitrogen stabilizers. (6)
PFAS Per- and polyfluoroalkyl substances (PFAS) are a family of at least
4730 compounds containing carbon-fluorine bonds. Their lack of a
chemically active group makes them very inert and highly resistant to
degradation, both during their use andin the environment. Most PFAS
are also easily transported in the environment covering long distances
8
Term or acronym Meaning or definition
away from their releasing point. PFAS have been frequently observed
to contaminate groundwater, surface water and soil. Cleaning up
polluted sites is technically difficult and costly. These substances are
accumulating in the environment, drinking water and food. (7)
Pharmaceuticals Pharmaceuticals (medicines, medications, drugs) are chemical
substances used in the prevention, diagnosis or treatment of disease.
Precautionary principle The precautionary principle is designed to assist with decision-
making under uncertainty and is a core principle of EU environmental
law, enshrined in Article 191(2) of the Treaty on the Functioning of
the EU. The classic definition of ‘a precautionary approach’ comes
from the 1992 Rio Declaration on Environment and Development,
stating that: "Where there are threats of serious or irreversible
damage, lack of full scientific certainty shall not be used as a reason
for postponing cost-effective measures to prevent environmental
degradation" (UNEP 1992)’. In cases where the precautionary
principle was invoked this was done under the following conditions:
1) an established identification of potentially adverse effects; 2)
evaluation of the scientific data available; 3) a (qualitative)
assessment of the extent of scientific uncertainty.
Population Equivalent (p.e.) 1 p.e. describes the average water pollution load released by one
person in one day
The UWWTD definition: ‘1 p.e. (population equivalent)’ means the
organic biodegradable load having a five-day biochemical oxygen
demand (BOD5) of 60 g of oxygen per day.’ In the UWWTD IA, one
p.e. includes on average 11.18 g/day for total Nitrogen, and 1.68
g/day for Phosphorus.
Priority (Hazardous) Substance
(P(H)S)
Surface water pollutant listed in Annex X of the WFD (later
superseded by Annex I to the EQSD) and for which measures have to
be taken to reduce emissions.
Among these, there are ‘priority hazardous substances’ which means
substances identified as PBT or of equivalent concern and for which
measures have to be taken to phase-out emissions completely.
River Basin Management Plan
(RBMP)
River Basin Management Plans are the key tools for implementing the
Water Framework Directive (WFD). They are drawn up after
extensive public consultation and are valid for a six-year period. (8)
Surface water Inland water, except groundwater, and transitional and coastal waters,
as well as, with respect to chemical status, territorial waters.
TFEU Treaty on the Functioning of the European Union
Article 191(2) of the TFEU states that the “Union policy on the
environment shall aim at a high level of protection taking into
account the diversity of situations in the various regions of the Union.
It shall be based on the precautionary principle and on the principles
that preventive action should be taken, that environmental damage
should as a priority be rectified at source and that the polluter should
pay”.
9
Term or acronym Meaning or definition
Watch List (WL) For surface waters: Mandatory mechanism, established by the 2013
revision of the Environmental Quality Standards Directive (EQSD),
to collect data from MS on surface water pollutants of potential EU-
wide concern.
For groundwaters: Voluntary mechanism, established in the CIS, to
collect data from MS on groundwater pollutants of potential EU-wide
concern.
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1 1 INTRODUCTION: POLITICAL AND LEGAL CONTEXT
The European Green Deal (EGD) is Europe’s growth strategy ensuring that by 2050 the EU
is transformed into a climate neutral, clean and circular economy, optimising resource
management while minimising pollution. Water is an essential resource and therefore an
integral part of the EGD ambition and initiatives, building upon the EU’s comprehensive and
mature water law. Since the 1990s, significant progress has been achieved in improving water
quality through the implementation of many EU laws regulating pollution sources1
. By
reducing pollution at source and by treating water before release into the environment, many
past pollution problems were tackled successfully. However, the EU’s water bodies are still
at risk from certain hazardous substances, which can affect ecosystems and threaten human
health. And new pollutants of concern are emerging.
This initiative is part of the Commission Work Programme 2022 and a key action in the Zero
Pollution Action Plan (ZPAP)2
. This initiative, like all EGD-initiatives, aims at ensuring that
objectives are achieved in the most effective and least burdensome way, and comply with the
‘do no significant harm’ (DNSH) principle (see glossary for the water related details). It fine-
tunes, updates and adapts existing legislation in the context of the EGD. Its focus is on
defining the zero pollution ambition for water pollutants and thereby the level of protection
for human health and natural ecosystems. The measures necessary to achieve this level of
protection are addressed by several other, closely related, initiatives under the European
Green Deal, e.g.3
:
 The Biodiversity and Farm to Fork Strategies, which aim to reduce pesticide use,
nutrient losses, and sales of antimicrobials (by 50%), as well as fertilizer use (by 20%)
by 2030. Much of it is to be achieved by the ongoing revision of the Directive on the
Sustainable Use of Pesticides. The upcoming review of Regulation (EC) No.
1107/20094
concerning the placing of plant protection products (PPPs) on the market
in the European Union could also play a role.
 The EU Plastics Strategy and the upcoming EU microplastics initiative, which aim to
deliver on the ZPAP target to reduce waste, plastic litter at sea (by 50%) and
microplastics released into the environment (by 30%) by 2030;
 The Single Use Plastics Directive (SUPD) which aims to limit the use of single-use
plastic products e.g. by introducing waste management and clean-up obligations for
producers (incl. Extended Producer Responsibility (EPR) schemes), and setting
specific targets including; a 77% separate collection target for plastic bottles by 2025,
increasing to 90% by 2029; as well as incorporating 25% of recycled plastic in PET
bottles from 2025, and 30% from 2030.
 The Circular Economy Action Plan, which announces in particular measures to reduce
microplastics and the evaluation of the Sewage Sludge Directive (SSD), regulating the
1
E.g. Urban Waste Water Treatment Directive, Industrial Emissions Directive and Nitrates Directive
2
Specific commitment to ‘Revise the EQSD and the GWD’ (Action 10, Flagship 3)
3
A comprehensive list of relevant actions also considered in the baseline assessment is available in Annex 5.
4
A plant protection product ("pesticide") usually contains more than one component. The component that works against pests/plant diseases
is called an "active substance". Active substances can be chemicals or micro-organisms. Active substances can only be approved for use in
plant protection products if they fulfil the approval criteria that are laid down in Regulation (EC) No. 1107/2009.
11
quality of sludge used in agriculture; the new Regulation on minimum requirements
for water reuse regulates the quality of waste water if used for agricultural irrigation5
.
 The Chemicals Strategy for Sustainability, which recognises that chemicals are
essential for the well-being of modern society, but aims to better protect citizens and
the environment against their possible hazardous properties;
 The 2019 Strategic Approach to Pharmaceuticals in the Environment (flowing directly
from the 2013 revision of the EQSD) and the Pharmaceuticals Strategy for Europe,
which both underline the environmental and potential health impacts of pollution
from pharmaceutical residues and list a range of actions designed to tackle these
challenges;
 The Industrial Emissions Directive, currently under revision, which regulates
emissions from a large number of installations in the industrial and agricultural sector;
 Internationally, treaties such as the Stockholm Convention on Persistent Organic
Pollutants and the Minamata Convention on Mercury prohibit or restrict the use of a
number of the substances covered by this Impact Assessment. The EU, as a Party to
these treaties, constantly ensure that EU legislation is kept in conformity with
developments agreed in that context. Negotiations on a new global, legally binding
instrument on plastics have been set in motion in 2022.
 This proposal is also consistent with the final report of the Conference on the Future
of Europe and the explicit recommendations it contains from citizens on zero
pollution in general and in particular the proposals on tackling pollution. Especially,
the following final proposals are specifically relevant in this context:
o Proposal 1.4 to: ‘Significantly reduce the use of chemical pesticides and
fertilizers, in line with the existing targets, while still ensuring food security, and
support for research to develop more sustainable and natural based alternatives’;
o Proposal 2.7 to: ‘Protect water sources and combat river and ocean pollution,
including through researching and fighting microplastic pollution’.
It will, however, ultimately be for Member States (MS) to put together the most cost-effective
mix of measures to achieve the objectives set out by this initiative. This is set out in the
WFD, the main policy framework for preserving and restoring the quality of European water
bodies, laying down a common framework for all other water policies within an integrated
planning approach. It aims to ensure that all surface and groundwater bodies achieve “good
status” by a certain deadline and that there is no further deterioration of water quality. For a
surface or groundwater water body (WB) to be classified in overall good status, both
chemical status and either ecological or quantitative status, respectively, must be at least
good. In particular, for surface waters, WFD Article 16(2) requires the establishment of a list
of PS and priority hazardous substances (PHS) which present a significant risk to or via the
aquatic environment. The first such list (constituting Annex X to the WFD) was established
in 2001, and EQS were established in 2008 in the Environmental Quality Standards Directive
(2008/105/EC - EQSD). The list was last revised in 2013 by Directive 2013/39/EU and
currently contains 45 substances including industrial chemicals, pesticides, and metals.
The 2013 revision of the EQSD (Article 8(b)) introduced an obligation to establish a so-
called watch list (WL) of substances for which EU-wide monitoring data are to be gathered to
inform the review of the PS list. The first WL was established by Commission Implementing
Decision (EU) 2015/495 and included macrolide antibiotics (Erythromycin, Clarithromycin
5
Regulation (EU) 2020/741 on minimum requirements for water reuse: https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX%3A32020R0741
12
and Azithromycin, used to treat infections), estrogenic hormones (17-beta-estradiol (E2), and
17-alpha-ethinylestradiol (EE2), mainly used in contraception), neonicotinoid-pesticides (the
insecticides Imidacloprid, Thiacloprid, Thiamethoxam, Clothianidin, Acetamiprid) and
Diclofenac (an anti-inflammatory) were included in the first watch list. The list was updated
in 2018 and 2020.
For groundwaters, pollutants of EU-wide concern and their quality standards are listed in
Annex I to the Groundwater Directive (2006/118/EC - GWD) whereas MS have to consider
setting national threshold values(TVs) for the substances listed in Annex II. Annex II
substances are found only in a limited number of MS therefore no EU-wide action is needed.
Both Annexes were last revised in 2014. Annex I currently includes nitrates and active
substances in pesticides, incl. their metabolites, degradation, and reaction products, whereas
Annex II contains 12 pollutants or pollution indicators. The 2014/80/EU Directive amending
the GWD expressed the need to obtain information on additional substances posing a
potential risk for groundwater (Recital 4). In response to this, in the context of the Common
Implementation Strategy (CIS) supporting the implementation of the EU water acquis, a
voluntary watch list mechanism for pollutants in groundwater was introduced. Under this
Groundwater Watch List (GW WL) process, MS agreed to voluntarily collect data on
groundwater pollutants of potential EU-wide concern, to support the identification of
(emerging) pollutants for which groundwater quality standards or threshold values should be
set. The “Voluntary Groundwater Watch List Concept & Methodology” (9) describes the
identification process of substances to be put on the GW WL.
WFD Article 10 obliges MS to establish relevant emission limit values and ensure that all
point and diffuse source emissions are controlled based on best available techniques (BAT).
In addition, the EQSD and the GWD set out more precisely what ‘good chemical status’
means by defining the level of protection per pollutant and how it is assessed and monitored. .
Article 16(4) of the WFD requires the Commission to regularly review, at intervals of at least
every four years, the list of PS that pose a risk to the aquatic environment, i.e. both surface
and groundwaters. Specifically, for surface water, Article 8 of the EQSD requires the
Commission to review Annex X of the WFD (the PS list), while, for groundwaters, Article
10 of the GWD requires the Commission to review every 6 years Annexes I and II of the
GWD itself. The revision, and this impact assessment, also serve to report to the EP and
Council, as referred to in Article 8 of the EQSD
In 2019, a Fitness Check (FC) evaluation of EU water legislation (10) was completed
covering the WFD, as well as the EQSD and the GWD. The FC concluded6
that, although the
legislation is largely fit for purpose, there is room for improvement in relation to tackling
chemical pollution. The obligation to review the lists of pollutants and their corresponding
standards provides an opportunity to also introduce some of the improvements warranted by
the FC. The changes considered by this initiative (see Chapter 5.4) are linked to the scope of
the lists of substances, the updating process as well as related monitoring and reporting
methods, which are all aimed at improving the regulatory response to emerging
environmental and health risks. Conclusions of the FC related to the slow progress towards
reaching WFD, EQSD and GWD objectives are not directly addressed by the proposed
intervention and are instead being addressed, at this stage, by stepped up enforcement actions.
6
Pages 120-121 (‘emerging challenges’) and 121-123 (‘EQSD and GWD’)
13
A possible revision of the lists of pollutants will also improve marine water quality and the
quality of bathing waters7
. There is also a direct link with soil health, in particular in relation
to the protection of groundwaters. The proposal therefore feeds into the preparations of the
new Soil Health Law foreseen for 2023. In line with the “A Europe fit for the Digital Age”
Communication, the potential benefits of digitalisation will be further explored, as they are
particularly relevant in the water sector. This will help reduce administrative burden.
Finally, the revision of the lists of pollutants directly contributes to achieving the Sustainable
Development Goals (SDGs), specifically SDG 6 on ensuring the availability and sustainable
management of water and sanitation for all8
, SDG 3 on ensuring healthy lives and promoting
well-being9
, as well as SDG 14 on protecting life below water10
.
2 2 PROBLEM DEFINITION
Air, water and soil pollution affect human health and biodiversity. Pollution is transferred
between different water compartments (from groundwater to lakes or rivers and from rivers
to the marine environment) as well as different environmental compartments (air/water/soil).
Tackling water pollution is therefore a cornerstone for achieving the Zero Pollution ambition.
Water pollution is also one of the significant pressures affecting European surface and ground
waters (11). This initiative addresses the identification of new pollutants of concern and
adapts the existing lists of pollutants to the latest scientific and technological progress. This
impact assessment does not address the – current – underachievement of the ‘good chemical
status’ legal objective overall11
, which forms the object of the ongoing assessment, by the
European Commission, of the 3rd
River Basin Management Plans (RBMPs), covering the
crucial 2021-2027 time-period and which all MS should have submitted by March 202212
.
Box 1: Status of EU freshwater bodies as reported in 2nd
River Basin Management Plans
The 2nd
RBMP reporting showed that only 38% of EU surface water bodies are in good chemical status, while 46% are not
achieving good status and the status of 16% is unknown (12). There are substantial differences between MS, as shown in
Figure B1.1. Some report that over 90% of their surface water bodies are in good chemical status, while others report this
for fewer than 10%.
7
And thereby help in the review of the Marine Strategy Framework Directive (MSFD) and of the Bathing Water Directive.
8
Specifically target 6.3: Improve water quality by reducing pollution and minimizing the release of hazardous chemicals and materials by
2030.
9
Specifically target 3.9: Substantially reduce the number of deaths and illnesses from hazardous chemicals and water pollution and
contamination by 2030.
10
Specifically target 14.1: By 2025, prevent and significantly reduce marine pollution of all kinds, in particular from land-based activities,
including marine debris and nutrient pollution.
11 Under the WFD, MS had time until 2015 to ensure good chemical status for their waterbodies, or until 2027 if achieving good status is disproportionally costly.
12 A total of
11 MS have reported their RBMPs by 5 S
eptember 2022
.
14
As regards groundwater, the 2nd
RBMP reporting showed that 75% of EU groundwater bodies are in good chemical status,
while 24% are not achieving good status and only for 1% the status is unknown (12). There are substantial differences
between MS, as shown in Figure B1.2. Some report that 100% of their groundwater bodies are in good chemical status,
while others report this for 3%.
Figure B1.2: Chemical status of all Groundwater bodies per Member State (12)
2.1 2.1 What are the problems?
The problem definition rests mostly on the findings of the 2019 Fitness Check13
(FC) related
to chemical pollution, implementation, administrative simplification, and digitalisation. The
key issue is that the current legislative scope does not sufficiently protect human health and
ecosystems. In addition, several administrative and implementation impediments reduce the
effectiveness of the legislation and raise the administrative burden of the legislation. The FC
concluded that the key area to improve and to achieve better results is on chemicals. While
there is evidence that the WFD, EQSD and GWD have led to reduced chemical pollution of
13
https://ec.europa.eu/environment/water/fitness_check_of_the_eu_water_legislation/documents/Water%20Fitness%20Check%20-
%20SWD(2019)439%20-%20web.pdf
Figure B1.1: Chemical status of all surface water bodies for all priority substances per Member State (12)
15
the EU’s waters, the analysis points to three areas in which the current legislative framework
is sub-optimal:
 the differences between the MS are much larger than what can be explained by national
differences (variability in lists of local pollutants (river basin-specific pollutants and
pollutants posing a risk to groundwater bodies) and the limit values they should not
exceed);
 updating the list of PS (i.e. adding or removing substances and the corresponding quality
standards) is a lengthy process, partly because it takes time to gather the necessary
scientific evidence and partly because of the ordinary legislative procedure;
 the EQSD and GWD evaluate the risk to people and the environment based mainly on
single substances, not taking into account the combined effects of mixtures, and
inevitably cover only a tiny proportion of the substances present in the environment.
Figure 2.1.1 shows the “intervention logic” which links problem drivers, problems,
consequences and specific objectives to the options under consideration. All policy options
are expected to intervene at the driver and problem level. The intervention logic is the same
both when single pollutants are considered and when their combination is at stake.
Figure 2.1.1: Intervention logic
2.1.1 2.1.1 Lack of ecosystem and human health protection from emerging risks
Emissions of pollutants in surface and groundwater are linked to agricultural production and
animal farming activities (pesticides, pharmaceuticals, nutrients), industrial activities
(emissions linked to production of various industrial pollutants), consumption and disposal of
16
products containing pollutants (e.g. PFAS a.k.a. “forever chemicals”, or plasticizers), and
also healthcare (increased consumption, partially due to ageing population). Numerous
ubiquitous and emerging pollutants released from these anthropogenic sources continue to
have detrimental effects on aquatic ecosystems, limit the services they provide (recreation,
drinking water, etc.) and constitute a cause for concern for public health. Significant levels of
concern regarding various surface and groundwater pollutants were also flagged during the
consultation activities (see Box 2), indicating that more needs to be done to reduce their
presence in the aquatic environment.
Box 2: Concerns regarding surface and groundwater pollutants expressed during consultation activities
In the Open Public Consultation (OPC) respondents were asked to rate their concern about the presence of various
emerging pollutants in water bodies on a scale of 1 (not at all) to 5 (very much). For surface water, respondents were most
concerned about pharmaceuticals (average score of 4.2; rated ≥4 by 72% of respondents) as well as pesticides (including
biocides), substances released from household items (e.g. compounds from plastic products, flame retardants, detergents,
disinfectants), and industrial chemicals (e.g. PFAS) (all scored 4.1 on average; rated ≥4 by 72%, 68% and 67% of
respondents, respectively). A slightly lower, although still high, level of concern was expressed regarding metals and
microplastics (both scored 3.9 on average; rated ≥4 by 63% and 59% of respondents respectively).
For groundwater, OPC respondents were most concerned about fertilisers (4.3; 71%) and pesticides (4.2; 76%), closely
followed by industrial chemicals (incl. PFAS) (4.0; 64%), pharmaceuticals (3.9; 63%) substances released from household
items and metals (3.8; 57%). Least concern was expressed regarding microplastics (3.5; 47%).
These substance groups were also of high importance to the water stakeholders and experts, as flagged in the Targeted
Expert Consultation (TEC). Participants in the TEC were most concerned about individual pharmaceutical substances
(61%), (micro)plastics (59%), PFAS (56%), neonicotinoid pesticides (55%) and pyrethroid pesticides (44%).
The current legislative scope covers 53 single substances or groups of substances for surface
water and 14 for groundwater, including pesticides (their relevant metabolites, degradation
and reaction products), various industrial chemicals (e.g. PAHs), (heavy) metals and other
pollutants/indicators (e.g. nitrates and nitrites, ammonium, chloride) (see Annex 8 for the full
lists). Out of the 21 currently listed pollutants considered under this initiative (see section
5.2.1), mercury, nickel, industrial chemicals PBDEs, PAHs (incl. Fluoranthene), Tributyltin
and Nonylphenol are among the top 15 most frequently reported PS causing failure to achieve
good chemical status in surface water bodies (12) and therefore remain highly relevant.
It should be noted that Member State a required to report they meet (pass) or do not meet
(fail) quality standards, not the actual amount of pollutants, their geographical or sectoral
sources, therefore, the EU-wide picture is of actual amounts (Table A11.2 in Annex 11) is
incomplete.
Most of the currently listed pollutants had long been recognised as harmful to, or via, the
aquatic environment; however, they are only a small subset of the thousands of chemicals
found in water bodies. The problem is particularly apparent for PFAS, microplastics and
pharmaceuticals. PFAS have been detected at more than 70% of the groundwater measuring
points in EU MS (13); investigations reveal that existing thresholds are clearly exceeded at a
considerable number of locations. Reported environmental concentrations and associated
risks of microplastics are likely underestimated (14) because most studies fail to detect the
smallest particles. Pharmaceutical contaminants are widely found in surface and ground
waters (15) (16) (17), and several publications (18) (19) (20) (21) show that medicines, (ionic
/nano) silver and antibiotic residues can have negative effects on aquatic organisms and/or
contribute to antimicrobial resistance (AMR).
17
Box 3: PFAS
A main source of PFAS to humans and the environment is their production and use in industrial and professional
installations, e.g. as production of fluoropolymers, use of fire-fighting foams, use in the production of textiles, paints and
printing inks and food contact materials. Another source is the release from consumer products, such as textiles, polishing
and cleaning products, cosmetics and food contact materials, during their use and at the end of their life. Analysis of
sampled products showed that the most commonly detected PFASs in the samples collected in 2016 were PFOA followed
by PFHxA/PFBA, PFDA.14
PFAS can be released to the environment from industrial and municipal waste-water treatment
plants, landfills, recycling and incineration plants and from re-use of contaminated sewage sludge. The number of sites
potentially emitting PFAS has been estimated to be approximately 100 000 in Europe (25). PFAS pollution is found in
surface and groundwater throughout Europe, sometimes in high concentrations, and is also detected in water, sediment and
animals in all seas. Although PFAS-free solutions already exist, these chemicals are still unnecessarily added to many
consumer products creating an irreversible toxic legacy within the EU.
Substances are considered for listing under the EQSD and the GWD based on the scientific
assessment of their toxicity to humans and the aquatic environment, e.g. because they are
directly toxic, limit organisms’ ability to reproduce or because they bio-accumulate in food
chains and have the potential to cause cancer. The key element of this evaluation is
(eco)toxicological data on persistence, bioaccumulation, carcinogenicity, mutagenicity,
reprotoxicity and endocrine disrupting potential of chemicals. Since the adoption of the
existing EQSs in 2008 and 2013, new evidence has become available for some substances
already on the Priority Substance (PS) list. This recognises that the scientific understanding
has advanced considerably, and that the aquatic environment is not protected as well as it
could be, either because the threshold is too high, thus underplaying the risk, or because it is
too low, hence overplaying the risk and potentially drawing resources away from other, more
harmful substances.
Furthermore, without addressing pollutant mixtures, ecosystem and human health protection
will also remain inadequate. It is estimated that hundreds of chemical mixture combinations
occur in water bodies throughout the EU (21). Significant pressures stem from the possible
cumulative effects of pollutant mixtures, as these may be more toxic than individual
compounds comprising the mix.
Finally, the occurrence of certain pollutants within water bodies, such as pesticides, can vary
significantly dependent on, for example, seasonal economic activities. In agriculture, for
example, specific application windows for certain pesticides can result in large temporal
variations of levels in water bodies. Obtaining the peak concentration value is important for
an adequate health and environmental risk assessment.
Box 4: Views on key regulatory issues contributing to surface and groundwater pollution expressed during
consultation activities
During the Open Public Consultation (OPC), stakeholders considered the most important issues to be the lack of
investment for emissions reduction and lack of incentives to take control measures (such as technological improvements)
at the source of pollution (both with average score of 3.8 on a scale from 1 – not at all – to 5 – very much; rated ≥4 by
66% and 65% of respondents, respectively). Many respondents also felt that there was a lack of enforcement and
implementation of existing legislation and lack of use of ‘precautionary’ and ‘polluter pays’ principles when assessing
risks from new emerging substances (both with average score of 3.7; rated ≥4 by 62% of respondents).
14
https://norden.diva-portal.org/smash/get/diva2:1118439/FULLTEXT01.pdf
18
2.1.2 2.1.2 Implementation deficits
The 2019 Fitness Check found that there is a trade-off between the flexibility of the
Directives, which is needed to enable location-specific water management, and the
complexity that this flexibility creates, which forms an impediment to enforceability and
achieving better results. Lack of a harmonised approach among MS to derive EQSs for river
basin-specific pollutants (RBSPs, which are identified by MS as ‘locally’ relevant pollutants,
but do not pose an EU-wide risk) has resulted in significant differences in the number of
identified substances and their corresponding EQS values. In addition, the differences
between national quality standards (QS) set by MS for groundwater polluting substances
under Annex II of the GWD are much larger than could be explained by national disparities
in, for example, chemical use. In many cases, these variations occur due to various other
factors, such as political will, resistance to change or insufficient technical capacity. The lack
of harmonisation was found by the FC to render the comparison between MS difficult for
substances in Annex II, thus hindering the assessment of EU-wide risks.
The administrative burden of data management and reporting, although not disproportionate
given the breadth and complexity of the legislation and the need for it to underpin
implementation and enforcement, remains comparatively high. Reporting systems require a
very large amount of data and are resource-intensive, needing significant human and financial
contributions. Moreover, because reporting only informs whether a water body (WB) is in
good status or not, the insights into the magnitude of exceedances and the related ‘distance to
target’ are severely limited. This leads to opaque decision-making processes on remediation
and policy actions to improve water quality, as it is unclear if the most important problems
and the biggest exceedances are tackled first. Moreover, the data are often outdated, also at
EU level, which reduces the effectiveness of policy making.
Finally, updating the lists of pollutants affecting surface and groundwaters can only be done
via the ordinary legislative procedure. Apart from being resource intensive and time-
consuming, it could also be argued that, for what is essentially adapting to scientific progress,
the ordinary legislative procedure is not the most adequate. The time lag between the initial
risk assessment and subsequent legislative changes slows policy response to emerging
environmental and human health risks.
Box 5: Progress in WFD implementation
The 6th
WFD implementation report reveals improvements in knowledge and reporting on the WFD compared to the
previous cycle15
. MSThe trend of continuous decline of water quality has been stabilised and partly reversed. Although
compliance with the WFD objectives is slowly increasing achieving full compliance with the objectives of EU water
legislation before the end of the third cycle (in 2027) looks very challenging.
2.2 2.2 What are the problem drivers?
The problems described above are largely driven by gaps and inefficiencies of the legal
framework. Findings of the 2019 FC of the WFD and the FD conclude that ubiquitous
pollutants and/or contaminants of emerging concern, pollutant mixtures and seasonal
variations of emissions are not adequately captured under the current legal scope; the existing
flexibilities set out in the legislation are not effective and the reporting system is adequate but
resource intensive.
15
https://ec.europa.eu/environment//water/water-framework/impl_reports.htm
19
2.2.1 2.2.1 Gaps in the legal framework
2.2.1.1 Emerging pollutants
While current regulatory efforts focus on monitoring and assessing various legacy chemicals,
many more anthropogenic chemicals detected in surface waters are currently not included in
the list of priority (hazardous) substances (PS/PHS) set out in Annex I of the EQSD, or in the
list of harmful substances in groundwater laid out in Annexes I & II of the GWD. The
outdated status of the EU legal scope leads to risks for ecosystems and human health.
The technical process underpinning this impact assessment identified an EU-wide risk for 24
substances (or substance groups) for surface water and 3 groups for groundwater,
highlighting the size of the scope gap. Data on the current levels of these pollutants in EU’s
water bodies are reported under the mandatory surface water and voluntary groundwater
watchlist mechanisms, however, the picture is very fragmented, because only a few MS
provide actual measured concentrations under the Surface Water Watch List, despite an
obligation to do so. Existing concentration data have been submitted by 1 to 10 countries (see
Table A11.1 in Annex 11), therefore, data are only available for each new pollutant from a
limited number of countries. On request of the MS, this data has been anonymised, hence it is
not possible to name which MS reported specific values. For groundwater the picture is also
incomplete.
The delay of the process and the scope for identifying emerging pollutants is also of concern.
The SW WL mechanism only addresses a limited number of emerging pollutants, meaning
that the legislation is not up to date with the latest scientific knowledge. This leads to a
delayed response or no response at all to health and environmental risks from emerging
pollutants. Stakeholders support the SW WL, but have no consensus over necessary
monitoring frequencies or the frequency of updating the list of PS with WL substances.
2.2.1.2 Pollutant mixtures
Current monitoring and reporting practices used under the WFD focus only on individual
substances or groups of substances, and do not adequately capture pollutant mixtures.
Individual chemicals may interact additively16
, synergistically17
or antagonistically18
with
each other, and in some cases prove toxic at concentrations below those at which they are
toxic on their own. Exposure to chemical mixtures does not necessarily translate into adverse
biological effects, so that it is not always clear whether mitigation measures are needed.
Thus, adequate monitoring and assessment strategies are essential to provide information on
which mixtures are present and which have associated combined effects. This knowledge is
key for adequate risk evaluations, as currently these are only based on individual risks of
single substances, but not on the combined (cumulative) effects of varying mixtures of
different substances. Chemical monitoring of a few selected individual chemicals is less
informative for identifying the full extent of impacts on water quality, whilst the probability
of overlooking significant risks is high (23).
16
Additive interaction means the effect of two chemicals is equal to the sum of the effect of the two chemicals taken separately.
17
Synergistic interaction means the effects of two chemicals taken together is greater than the sum of their separate effect at the same doses.
18
Antagonistic interaction means that the effect of two chemicals is actually less than the sum of the effect of the two drugs taken
independently of each other.
20
2.2.1.3 Seasonal variation of emissions
Another identified gap is that monitoring does not adequately capture, in some cases,
seasonal variations of emissions. This applies to the monitoring of substances listed under the
WFD/EQSD and the GWD as well as under the SW and GW WL mechanisms. The current
once-per-year monitoring may miss annual peaks of, for example, pesticides with a specific
application window used in agriculture. Consequently, risks may be underestimated and
managing the full extent of the impacts on biological and other water quality elements is
difficult. This is important for example with regard to mercury. Understanding spatial and
temporal trends for mercury is crucial in assessing measures taken both at European and at
global level. It is only by understanding the movement and interaction of mercury within our
environment that this persistent problem can be tackled. This would also allow to monitor the
effects of revised Best Available Technique (BAT) conclusions for large (coal) combustion
plants, and an EU wide ban on dental amalgam.
2.2.2 2.2.2 Inefficiencies of the legal framework
2.2.2.1 Flexibility
Surface and groundwater pollution is a problem in many parts of Europe19
, even if the gravity
and the exact type of pollutants vary between river basins. Although part of this divergence
can be explained by the different natural, geological and hydromorphological conditions of
each river basin, an important contribution comes from anthropogenic activities (from
agriculture, industry, urban areas or other human activities), whose impact on the status of
waters may be of different magnitude and last for variable time lengths. The legislation takes
this fact into account by setting common standards for EU-relevant pollutants while leaving
MS the freedom to set river basin specific standards for other pollutants, which play a role
locally or regionally, but not per se EU-wide. Therefore, limited guidance for setting national
chemical quality standards for RBSPs is prescribed in the WFD (Annex V section 1.2.6).
This inherent flexibility has however resulted in poor comparability of the EQS values
between MSs for RBSPs20
and the corresponding monitoring schemes and regulatory
measures. Furthermore, the contrasting methodologies used to select RBSPs also result in
inconsistent identification of relevant substances. The FC concluded that ‘this is an instance
where the flexibility left to the MS has led to sub-optimal results’.
Similarly, the GWD allows considerable flexibility for MS when setting national threshold
values (TVs) for the pollutants that are only relevant in some MS and therefore listed in
Annex II. The process usually takes into consideration receptors, risks, and pollutant
background levels. The inherent flexibility provided in the GWD has resulted in largely
varied ranges of TVs across the EU21
. For pollutants/indicators with at least 10 nationally
established TVs, the differences range from a factor of 1 to 50. Some of these variations are
logical, as they depend on the natural background levels determined by the geological nature
of the area, but others depend exclusively on the methodologies used to set the TVs. The FC
therefore concluded that the 'national' thresholds route does not work effectively, thus
justifying harmonised EU action. Moreover, the voluntary nature of the Groundwater Watch
19
Of the 146,460 surface water bodies in Europe, 31% is affected by atmospheric pollution, 33% by diffuse sources and 15% by point
sources (EEA).
20
Surface water: Standard types and threshold values for RBSPs [table] and Surface water: Standard types and threshold values for RBSP
[country overview]
21
List (GW WL) limits the evidence gathered of pollutants present in groundwater bodies,
ultimately limiting the development of groundwater regulation and the establishment of TVs.
Substances no longer found
Emissions of some currently listed substances have decreased or ceased and the scientific
consensus (considering legal bans of substances and actual measurements of the concerned
substances) indicates that there may no longer be an EU-wide threat to surface water quality
from some such substances. It stands to reason that the small numbers of MSs reporting
failures, and the exceedances being of a very limited magnitude, that it is justifiable that these
substances are candidates to be proposed for deselection as they no longer pose an EU-wide
risks.
2.2.2.2 Resource intensity
The existing legal framework for updating the lists of pollutants is partially built on the
Watch List system and occurs on a 6-year review cycle. Substances which are identified as
having a significant EU-wide risk are then considered as candidates for the next review of the
PS list. However, the noted time lag between revisions and simultaneous delay in obtaining
conclusive data makes it challenging to have an up-to-date legislative alignment with science
and a quick response to relevant health and environmental risks.
Furthermore, the reporting and data sharing system set up under EU water legislation could
be improved via simplification and automation. Monitoring techniques utilising satellite data,
automated sensing technologies, citizen science and smartphone applications are still under-
implemented in some MS. Although progress has been made towards further digitalisation of
monitoring and reporting, the potential is still far from exploited.
Box 6: Views on ways to improve policy effectiveness expressed during consultation activities
During the OPC, the vast majority of stakeholders supported all improvements listed in the questionnaire. Improved
collection of data on new pollutants in a harmonised format via a common information platform was considered the most
essential (average score of 4.2 on a scale from 1 – not at all – to 5 – very much; rated ≥4 by 77% of respondents). More
swift updates of GWD Annexes (average score of 3.7; rated ≥4 by 62% of respondents) and of the priority substance list
(average score of 3.6; rated ≥4 by 58% of respondents) were considered overall less important in future strategies to
address pollution.
2.3 2.3 How likely is the problem to persist?
The problem of an insufficient level of protection of the ecosystem and human health is
overall likely to persist. The dynamic baseline scenario (Chapter 0) shows that, despite the
implementation of existing legislation and planned new initiatives that address the problem of
pollution at source, pathway and end-of-pipe (IED and UWWTD revisions, PFAS ban, SUPD
revision, etc.), there continues to be a need to track actual progress and identify pollutants of
emerging concern also at the level of surface and groundwater bodies. Consequently, revising
the EU water legislation is necessary to better protect the aquatic environment and public
health from risks related to (emerging) toxic pollutants and their mixtures. All mentioned
groups of pollutants have common problems that arise from legislation not being up to date
22
with science, as well as a lack of harmonisation, inconsistent implementation, and
burdensome data management due to lack of adaptation to digital progress.
2.3.1 2.3.1 Persisting industrial substances and PFAS pollution
In the past decade, scientists identified several industrial substances that act as environmental
contaminants with estrogen-like properties including, dicofol, nonylphenols, PCBs,
endosulfan and Bisphenol-A. Endocrine disruptors are e.g. found in food containers, plastics,
furniture, toys, carpeting and cosmetics. Estrogenic hormones and endocrine disrupting
chemicals (EDCs) are detected at polluting levels in surface waters, e.g. sites close to waste
water treatment facilities, and in groundwater at various sites globally. There is evidence of a
causal relationship between estrogens in the environment and breast cancer and prostate
cancer. Estrogens also perturb fish physiology and can affect reproductive development in
both domestic and wild animals (24).
The group of Per- and polyfluoroalkyl substances (PFAS) is extremely prevalent in Europe’s
water. Some PFAS are classified as Persistent, Bioaccumulative and Toxic (PBT) and very
Persistent and very Bioaccumulative (vPvB)22
. The persistence, mobility and bio
accumulative nature of PFAS leads to negative effects for human health and biodiversity. The
bio-accumulative effects are e.g. illustrated by the results of an EU LIFE project which
showed that Per-fluoro-octane sulfonic acid (PFOS, one of the many PFAS substances, used
in stain repellents, impregnation agents for textiles, paper, and leather; in wax, polishes,
paints, varnishes, cleaning products for general use, in metal surfaces, and carpets)
concentrations in the livers of top predators are severely elevated compared to those present
in the fish they eat.
Apart from PFAS used in firefighting foam, PFAS emissions from coatings of carpets,
clothes, furniture, and paper (incl. food packaging), land spreading of residues from the paper
industry, car wash facilities, etc. will continue to cause water related environmental and
health concerns. Many countries23
currently deal with a myriad of PFAS related problems at
national level, e.g. by introducing PFAS restrictions and/or purification measures. The
increasing number of national measures underlines the need to urgently adopt EU-wide
harmonised quality standards. To avoid shifting the problem by substituting one PFAS
substance by another, a quality standard must be set for PFAS substances as a group. This is
particularly important for substances like (ultra)short-chain per-alkyl acid (such as
trifluoroacetic acid - TFA) of which very little toxicological data are yet available, but which
are rising and are expected to entail the same human health risks as other PFAS substances.
The harmful effects and persistence of PFAS are well-known; thus, several EU policies and
initiatives already partly tackle PFAS pollution, such as the European Chemicals Agency
(ECHA) proposal, under the Chemical Strategy for Sustainability, to ban forever chemicals
like PFAS from firefighting foams (26).
2.3.2 2.3.2 Persisting microplastics pollution
22
Perfluorohexane sulphonic acid (PFHxS) and its salts, perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA) and its salts,
nonadecafluorodecanoic acid (PFDA) and its salts (https://echa.europa.eu/candidate-list-table)
23
Countries like BE, DE, DK, ES, FR, IT, NL, SE and UK introduced (drinking water) standards up to a maximum 2 ng/l for PFAS
substances. Also, Denmark introduced a national ban on PFAS in food packaging.
23
Figure 2.3.1: World fibre production per type in million metric
tonnes between 1980 and 2030.
Microplastic pollution is omnipresent. Microplastics are detected in 80% of our livestock
feed, blood, milk and meat (27), and is also present in human blood (28). Microplastic
pollution spreads across borders, regions, species and ecosystems. An OECD report (29)
echoes the scale of the problem, indicating that "microplastics have been observed in all
surface waters and sediments of EU lakes (30) and rivers, as well as in drinking water”.
Scientists find microplastics practically in every water sample from EU lakes and rivers.
Studies from 2016 on the annual amounts of plastics entering surface and groundwater report
numbers between 1.15-2.41 million metric tons (31), whereas recent studies from 2021
already rate the global annual plastic input at between 9-23 million metric tons (14) (32) (33).
In the absence of action, the amount of plastic waste entering aquatic ecosystems could triple
(34) to around 53 million tonnes per year by 2030 (32) and quadruple by 2050. Recent
research showed that between 31,000 and 42,000 tons of microplastics (or 86–710 trillion
microplastic particles) are spread on EU farmlands every year by the use of sewage sludges
in agriculture. Consequently, an average plot of farmland likely mirrors the microplastic
levels of ocean surface waters (35). Once in the environment, plastic particles break down to
nano-plastics. As a result, concentrations of microplastics will continue to rise for decades
even if all plastic emissions cease now (14). Combined with the continuous degradation of
plastics already in the environment to micro and nano-plastics, this will result in a 50-fold
increase of surface water and ocean (micro) plastic concentrations by 2100. Although EU
initiatives like the Single Use Plastics Directive, the proposed restriction of intentionally
added microplastics (36), the upcoming initiatives on unintentional releases, the Textile
Strategy and other planned EU actions will reduce microplastics at source, their anticipated
effect will only result in an expected reduction of emissions by 10% to 30% at best (see
Chapter 0 and Annex 4). Projected increases in plastic production, road transport volumes
and synthetic textile production in the next decades also predict an exponential growth in
plastic emission levels under the business-as-usual scenario. For unintentional releases of
microplastics from tyre wear, JRC estimates show a 16% increase in driving mileages from
passenger road transport by 2030 and 30% for by 2050. Freight transport mileage is estimated
to increase by 33% by 2030 and 55% by 2050 (37). Climate change effects, e.g. more
frequent heavy rainfall events,
will exacerbate the problems
linked with releases of those
microplastics via urban runoff
and storm water overflows
(SWO), which the upcoming
revision of the UWWTD aims
to at least partly reduce. Also,
projections for unintentional
releases from textile fibre
foresee a 50% increase by 2030
under a business-as-usual
scenario (see Figure 2.3.1).
2.3.3 2.3.3 Persisting pharmaceuticals pollution
Pharmaceutical products (mainly medicinal products, but also other personal care products)
can act as environmental contaminants (38) (39) (40) (41) (42).
24
Personal Care Products (PCPs)
Personal Care Products (PCPs), including disinfectants, conservation agents, fragrances and
UV screens, contain substances that are problematic in the aquatic environment such as
silver, triclosan, microplastics and PFAS. Like pharmaceuticals, PCPs are designed to
maximise their biological activity at low concentrations and produce a prolonged action. The
major point source for PCPs are waste water treatment plants. Partially effective, the effluent
of waste water treatment plants does contain PCP residues, subsequently reaching surface and
groundwater.
Pharmaceuticals
Approximately more than 100,000 tons of medicinal products are consumed every year by
human patients, the European Union (EU) market being the second biggest consumer in the
world after the United States of America (USA) (43) (44). Moreover, 559 active
pharmaceutical ingredients are found in environmental sectors such as surface water,
groundwater, soil etc.
Some pharmaceuticals degrade relatively slowly, and their constant use can lead to
continuous environmental releases exceeding degradation rates. While the EU has a proactive
approach to reduce antibiotic use in animals as growth promotors / feed additives and
preventive use (45), the projected worldwide increase in the use of antibiotics in feed used for
rearing livestock animals (67% by 2030 compared to 2015 levels) (18) could nullify progress
or even potentially aggravate the problem. Ageing populations will also lead to an increased
use of pharmaceutical products increasing sales of medication ‘over the counter’, and a
higher demand for control of health risks for vulnerable age groups. In Germany,
pharmaceutical usage is projected to increase by 43-67% by 2045 as a result (from a baseline
of 2015). It is estimated that around 8-10% of pharmaceutical substances in the environment
originate from improperly disposed medicines - flushed down the toilet, poured into drains,
or otherwise disposed inappropriately in household waste by patients or even by medical
institutions (46) (47). Increasing awareness amongst citizens across the EU can therefore lead
to a change in behaviour that can make a substantial difference; a fact recognised under EU
waste policy. On top of the emissions from unused medicines, between 30-90% of the active
ingredients in pharmaceuticals are excreted unchanged after consumption (48), and enter the
environment via sewage treatment works24
. Alongside metabolites and degradation products,
they contaminate water and soil, threatening wildlife and human health. Incorrect disposal of
unwanted drugs and pollution from pharmaceutical manufacturing plants further compounds
the problem. In Portugal, 1% of the solid waste produced originates from the medicine sector
(49).
Since conventional wastewater treatment plants are not equipped to fully remove
pharmaceuticals from wastewater, concentrations of active pharmaceutical ingredients in
soils, biota, sediments, surface water, groundwater and drinking water are likely to increase,
and thus action at EU level is necessary. The IA underpinning the upcoming revision of the
UWWTD states that pharmaceuticals represent a large share of potentially harmful
substances found in wastewater, corresponding to the toxic environmental load of 264 million
24
https://www.pharmaceutical-technology.com/comment/commentgreen-pharma-the-growing-demand-for-environmentally-friendly-drugs-
5937344/
25
population equivalent (p.e.). Over half of this amount (158 million p.e.) comes from
centralised treatment plants, with the rest emitted by other sources. Pharmaceutical pollution
is also tackled via other EU policies25
and initiatives such as the EU Strategic Approach to
Pharmaceuticals in the Environment which proposed over 30 actions across the life cycle of
pharmaceuticals (see Box 6 for a state of implementation).
Box 7: Status of the implementation of the Strategic Approach to Pharmaceuticals in the Environment
The EQSD, through article 8c of the amended Directive of 2013, required the development of a Strategic Approach to
Pharmaceuticals in the Environment. Since its adoption in 2019, good progress has been made in implementing the 33
actions it contains (see Figure B1.1), with some being well advanced or already completed. Most notably, the possible
revision of Urban Waste Water Treatment Directive (UWWTD) to address the increasing problem of micro-pollutants, is
scheduled for adoption by the Commission this year. The introduction of new pharmaceuticals in the Surface Water Watch
List26
, will increase knowledge about presence of pharmaceuticals in water. Within the same time frame, the revision of
the pharmaceutical legislation, should lead to more effective Environmental Risk Assessment of pharmaceuticals. In
addition, the EU is funding research projects on pharmaceuticals in the environment, e.g. support for the manufacturing of
greener pharmaceuticals.
2.3.4 2.3.4 Persisting pollution from metals
Silver is a rare but naturally occurring metal, often found deposited as a mineral ore in
association with other elements. Emissions from smelting operations, manufacture and
disposal of certain photographic and electrical supplies, coal combustion, and cloud seeding
are some of the anthropogenic sources of silver in the biosphere (CICADS, 2002). Silver is
registered under the REACH Regulation and is manufactured in and /or imported to the
European Economic Area, at ≥ 10 000 to < 100 000 tonnes per annum27
, whereas ECHA
25
Examples of EU legislation are mentioned in (124) and include Regulation (EC) No. 2160/2003 of the European Parliament and of the
Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents; 2013/652/EU: Commission
Implementing Decision of 12 November 2013 on the monitoring and reporting of antimicrobial resistance in zoonotic and commensal
bacteria and Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and
zoonotic agents, etc.
26
Commission Implementing Decision (EU) 2022/1307 of 22 July 2022 establishing a watch list of substances for Union-wide monitoring
in the field of water policy pursuant to Directive 2008/105/EC of the European Parliament and of the Council EUR-Lex - 32022D1307 - EN
- EUR-Lex (europa.eu)
27
https://circabc.europa.eu/ui/group/9ab5926d-bed4-4322-9aa7-9964bbe8312d/library/40a35be9-f2e1-4221-b12b-4d3c3f8fcb9d
61%
24%
15%
Started
Ongoing
Good Progress
Implemented/Achi
eved
Figure B6.1: Status of actions under the Strategic
Approach to Pharmaceuticals in the Environment
26
information from 2018 indicates that the current manufacture and use of silver amounts to
between 100,000 – 1,000,000 tonnes /year28
. The use of silver is steadily increasing (year-on-
year increases vary between 5-13% in recent years)29
.
This substance is used in the following products: metals, welding & soldering products, metal
surface treatment products, adhesives and sealants, biocides (e.g. disinfectants, pest control
products), coating products, laboratory chemicals, lubricants and greases, metal working
fluids and pharmaceuticals. The antibacterial activity of silver has led to an increased use of
silver in an ever wider range of consumer products. The different forms of silver, including
silver salts(e.g. silver nitrate), silver oxides and silver materials appear as silver wires, silver
nanoparticles (Ag-NP) and others, which are used in consumer and medical products. In
medical care, forms of (nano)silver are used, for example in wound dressings and catheters to
reduce infections. In consumer products, forms of (nano)silver are used, for example in sports
and other textiles, washing powders and deodorants, where (nano)silver should reduce odours
producing bacteria.
Products containing silver (in ionic form and as nanoparticles) can act as environmental
contaminants in general and in relation to the development of anti-microbial resistance.
Releases into the environment of silver are likely to occur from industrial use: in the
production of articles and manufacturing of the substance. Other releases to the environment
of silver are likely to occur from: indoor use in long-life materials (e.g. flooring, furniture,
toys, construction materials, curtains, foot-wear, leather products, paper and cardboard
products, electronic equipment) and outdoor use in long-life materials (e.g. metal, wooden
and plastic construction and building materials) (ECHA, 2021). A number of silver
substances are under evaluation under the Biocides Regulation (EU) No 528/2012 (BPR) .
Some of the biocidal product types under which the substances are notified require the
deliberate release of silver into water in order to exert the claimed effects, for example for
human hygiene, disinfection of food and feed areas, disinfection of drinking water or the
prevention of pathogens in cooling systems. Other applications may result in release of silver
into the environment via the sewage system or when exposed to rain outdoor, for example
preservation of paints or preservation of fibre, leather, rubber and polymerised materials.
When evaluating the end-of-life phase of silver containing products, it is assumed that their
waste management (recycling, wastewater treatment, landfilling, and incineration) is similar
to conventional products. Consequently, silver content in non-recycled waste ultimately ends
up in the environment, as waste in landfills, emissions from wastewater treatment plants, or
as residual waste from incineration plants.
According to ECHA information based on REACH dossiers, and tests performed with the
smallest nanoform with the highest specific surface area, have indicated that silver nitrate
(ionic silver) is more toxic than the nanoform of silver (toxicity to algae and long-term
toxicity to aquatic invertebrates) and that silver nitrate is equally or more toxic than the
nanoform of silver (toxicity to soil microorganisms).
28
Substance Evaluation Conclusion as required by the REACH substance evaluation process (Article 48 of REACH Regulation (EC) No
1907/2006) and evaluation report for Silver: EC No 231-131-3
29
https://www.silverinstitute.org/silver-supply-demand/
27
Scientific evidence demonstrates that micro-organisms become resistant against silver. Since
silver exhibits bactericidal activity at concentrations that are not cytotoxic to human cells,
they are important for medical use especially in the context of treatments of multi-resistant
bacteria. Also, silver strongly enhances the antibacterial activity of conventional antibiotics
even against multi-resistant bacteria through synergistic effects30
. Consequently, they are
important as a ‘last’ resort for treating infections with multi-resistant bacteria31
. The
bacterium ‘Acinetobacter baumannii’ (a bacterial pathogen) is listed as the "number one"
critical level priority pathogen because of the significant rise of antibiotic resistance in this
species32
. Currently, silver still has proven bactericidal activity towards this bacterium even
against strains that display multi-drug resistance. Therefore, it is of utmost importance to
avoid /limit silver resistance in bacteria to avoid limiting its effectiveness in treatments for
infectious diseases. With the rise of antibiotic resistant bacteria, there are also serious
concerns of pathogens developing resistance to silver.
An OECD project focusing on availability of vitro methods for the assessment of the
genotoxic potential of nanomaterials, by specific testing of nanomaterials in a stepwise
approach, evaluated the uptake of selected representative nanomaterials and their in vitro
cytotoxicity. For silver it was demonstrated that silver NMs induced cytotoxicity to various
degrees depending on the sensitivity of the used cell line 33
. While resistance to ionic silver is
recognised for many years, many scientific studies also demonstrate increasing bacterial
resistance to silver. Some resistance related mutations in bacteria are uniquely associated
with resistance to NAg, while others are protective against both NAg and ionic silver. These
mutations continued to be detected after the silver exposure had stopped, indicating that
heritable resistance characteristics continue to spread even after discontinued silver use. This
shows that silver cross-resistance occurs, and indicates the importance of avoiding heritable
silver resistance. Avoiding Ag-resistance is extra relevant as scientific evidence demonstrates
that, bacteria pre-exposed to sublethal dose of silver also exhibited increased resistance
toward antibiotics (ampicillin and Pen-Strep) with the half maximal inhibitory concentration
(IC50) elevated by 3 to 13-fold34
. Scientific evidence of silver-driven co-selection of
antibiotic resistance determinants is mounting and indicates that an increasing development
of resistance to silver will additionally increase the resistance to other antibiotics.
Consequently, it is of utmost importance to avoid (further) antibiotic resistances from
emerging through the process of co-selection35
, e.g. by reserving the use of silver based
antimicrobials only for treating infections36
, in order to preserve its efficacy.
30
Bacterial resistance to silver nanoparticles and how to overcome it; Aleš Panáček, Libor Kvítek, Monika Smékalová, Nature
nanoparticles, 2018, volume 13 p.65-71: https://www.nature.com/articles/s41565-017-0013-y
31
Effect of Graphene Oxide and Silver Nanoparticles Hybrid Composite on P. aeruginosa Strains with Acquired Resistance Genes; Povila
Lozovskis et.al., International Journal of Nanomedicine, 17 July 2020, p. 5147-5163: https://pubmed.ncbi.nlm.nih.gov/32764942/
32
Emerging Concern for Silver Nanoparticle Resistance in Acinetobacter baumannii and Other Bacteria; Oliver McNeilly, et.al, Frontiers in
Microbiology 16 April 2021, https://www.frontiersin.org/articles/10.3389/fmicb.2021.652863/full
33
In vitro cytotoxicity and cellular uptake evaluation gold, silica and silver nanoparticles in five different cell lines: Caco-2, A549, CHO,
V79 and TK6; Bogni Alessia et.al., 2022: https://publications.jrc.ec.europa.eu/repository/handle/JRC120791
34
Mechanisms of antibiotic resistance in bacteria mediated by silver nanoparticles; Chitrada Kaweeteerawat, et.al., Journal of toxicological
environmental health 2017; 80 p.1276-1289 https://pubmed.ncbi.nlm.nih.gov/29020531/
35
Emerging Concern for Silver Nanoparticle Resistance in Acinetobacter baumannii and Other Bacteria; Oliver McNeilly, et.al, Frontiers in
Microbiology 16 April 2021, https://www.frontiersin.org/articles/10.3389/fmicb.2021.652863/full
36
Heritable nanosilver resistance in priority pathogen: a unique genetic adaptation and comparison with ionic silver and antibiotics:
Elizabeth Valentin et.al. Nanoscale, 28 January 2020 p.2384-2392: https://pubmed.ncbi.nlm.nih.gov/31930233/
28
The widespread over-use of (nano)silver and has already led to the release and accumulation
of silver in water and sediment, in soil and even, wastewater treatment plants (WWTPs) and
is thus impacting microbial communities in different environmental settings. The resistance
mechanism is also linked to the increasing pools of many antibiotic resistance genes already
detected in samples from different environmental media, which will likely find their ways to
animals and humans. This is worrisome, as the increasingly indiscriminate over-use of silver
in non-essential consumer products further promotes the development of silver resistance in
bacteria. Finally, physical and chemical transformations of silver can shift the diversity and
abundance of microbes, including those that are important in nitrogen cycles and
decomposition of organic matter and other key metabolic processes. All in all, the combined
impacts underline the importance of minimising water related silver-emissions37
.
2.3.5 2.3.5 Persisting pesticide (incl. nrMs) pollution
Use of pesticides in Europe has not decreased in recent years. In 2019 almost 350,000 tonnes
of herbicides were sold in Europe, for use in the agricultural sector. The continued high level
of sales is consistent with measurements of high levels of pesticides in EU surface and
groundwater bodies.
In 2021 the EEA assessed pesticide levels in surface and groundwaters between 2013 and
2019. The findings showed that one or more pesticides or their metabolites were detected
above their effect threshold at 13-30% of all surface water monitoring sites each year.
Exceedances were mainly caused by the insecticides imidacloprid and malathion in surface
waters, and the herbicides MCPA, metolachlor and metazachlor. Exceedances of one or more
pesticides were detected at between 3% and 7% of groundwater monitoring sites, mainly by
atrazine and its metabolites (50). Atrazine, no longer approved for use continued to be found
in groundwater due to its persistence.
Exceedance rates of more than 30% were reported in 13 out of 29 countries for surface waters
and in one out of 22 countries for groundwater. High exceedance rates were mainly reported
at monitoring sites in small and medium-sized rivers.
Pesticides and pesticide degradation products (often classed either as ‘relevant metabolites’,
‘metabolites of no concern’ or ‘non-relevant metabolites’, nrMs)38
, have been identified (51)
in many surface water and groundwater bodies across the EU. New nrMs are emerging,
whilst concentrations of known nrMs are increasing. Also, the impact of cocktail effects on
(ground)water quality, i.e. from mixtures of various substances (incl. nrMs), remains
unaddressed in the absence of EU action. Monitoring results from recent SW WL show
increasing concentrations of pesticides across the EU. For groundwater ecosystems the
37
The impact of silver nanoparticles on microbial communities and antibiotic resistance determinants in the environment, Kevin Yonathan
et.al. Environmental Pollution 15 January 2022, p.293-
38
Sanco guidance (45), which is linked to the pesticide authorization regulation (EC 1107/2009), provides the following definitions:
Relevant metabolite as “a metabolite for which there is reason to assume that it has comparable intrinsic properties as the active substance
in terms of its biological target activity, or that it has certain toxicological properties that are considered severe and unacceptable with regard
to the decision-making criteria described in the text.”
Metabolite of no concern as “a) CO2 or an inorganic compound, not containing a heavy metal; or (b) an organic compound of aliphatic
structure, with a chain length of 4 or less, which consists only of C, H, N or O atoms and which has no "alerting structures" such as epoxide,
nitrosamine, nitrile or other functional groups of known toxicological concern or (c) a substance, which is known to be of no toxicological
or ecotoxicological concern, and which is naturally occurring at much higher concentrations in the respective compartment.”
Non-relevant metabolite as “a metabolite which does not meet the criteria for “relevant metabolites” or that for “metabolites of no
concern”.
Some MS do not differentiate between nrM and relevant metabolites and consider all pesticide metabolites as “relevant metabolites”.
29
situation is also worrying as they are generally more vulnerable to pollutants than freshwater
ecosystems due to slower biological and physical degradation processes combined with
longer residence times for water. This results in prolonged exposure times for groundwater
flora and fauna due to longer persistence of chemicals. Also, given the great difficulty to
restore contaminated groundwater bodies, an increased protection of groundwater ecosystems
is essential. Although pesticide emissions are expected to be partly tackled by upcoming EU
initiatives like the revision of the EU Sustainable Use of Pesticides Directive (SUPD), their
combined anticipated effect in short- to medium-term is modest (an expected emissions
reduction by 10-30% at best; see Chapter 0 and Annex 4) due to legacy pollution, the use of
substitutes and stocks.
2.3.6 2.3.6 Implementation deficits
Most problems referred to under implementation deficits (Chapter 2.1.2) are intimately linked
to the existing EU legislation and, therefore, certain to persist without changes made to it, or
non-legislative measures with the same effect such as voluntary higher frequency reporting
by MS. Issues linked to monitoring, reporting and the processing of data are a mixture of
requirements of EU legislation and voluntary practices developed over the years. While
incremental improvements (e.g. facilitating correct and efficient reporting) are continuously
made, the implementation deficits will by and large persist if no further initiative is taken.
2.3.7 2.3.7 Best practice to reduce water pollution at EU level
The evaluations of the Industrial Emissions Directive (IED) and the EU Pollution Release
and Transfer Register (E-PRTR) concluded that industrial installations covered by the IED
/E-PRTR, account for about 20% of pollutant emissions by mass to water (52). Consequently,
an effective implementation of the IED and E_PRTR, leads to reduced impacts on human
health and the environment through lower emissions to air, water and soil, reduced waste
generation and higher resource efficiency. Figure 3-7 from this evaluation shows that, for a
number of pollutants, an absolute decoupling of the total mass emissions to water from
industry Gross Value Added (GVA) took place. There is a visible declining trend for heavy
metals (Cd, Hg and Pb). In the case of Nitrogen (N), Phosphorous (P) and Total Organic
Carbon (TOC) releases have declined since 2007 as well, although to a lesser extent. At the
same time, figure 3-8 of the same evaluation also shows that, based on 2017 data, despite the
significant reductions seen to date in emissions from industrial activities, they still contribute
a significant proportion of total EU emissions for some important pollutants.
3 3 WHY SHOULD THE EU ACT?
3.1 3.1 Legal basis
The WFD, EQSD and GWD are based on Article 192(1) of the Treaty on the Functioning of
the European Union (TFEU) and so will be the revision proposal. Article 191(2) of the TFEU
states policies shall be based on the precautionary, the polluter pays and the preventive action
principles (see glossary). As recently re-affirmed by the Zero Pollution Action Plan and the
zero-pollution hierarchy explained therein, further action needs to be taken according to these
key provisions. While water quality standards for pollutants are science-based (see Chapter
5.1), the application of the precautionary principle is particularly pertinent for the pollutant
groups of microplastics, PFAS and nrMs. According to the TFEU, the EU shares
30
competences with MS to regulate environment and health in the field of water, while
considering the principles of necessity, subsidiarity and proportionality.
Also, WFD Article 7(3) contains an obligation for MS to ensure the necessary protection for
water bodies to avoid a deterioration of their quality and reducing the level of purification
treatment required in the production of drinking water. This includes setting stricter values at
EU level to ensure harmonised implementation of this requirement and contribute to
compliance with the revised DWD. Finally, EU water legislation includes review clauses that
enable the revision of the relevant annexes to adjust to technical progress and ensure that a
high level of protection is maintained. Currently, the WFD Article 16(4) stipulates the
Commission’s obligation to review, every 6 years, the list of PS that pose a risk to the aquatic
environment. Specifically, for surface water, the requirement to review Annex X of the WFD
(the PS list) is enshrined in Article 8 of the EQSD; while, for groundwater, Article 10 of the
GWD requires a review of Annexes I and II every 6 years.
3.2 3.2 Subsidiarity: Necessity of EU action
Surface and groundwater bodies in the EU are polluted by a range of different contaminants,
ranging from residues of pharmaceuticals, pesticides, microplastics, industrial chemicals,
metals, residues from products used domestically, and nutrients. While existing EU policies
contribute to reducing the emissions at source as well as at pathways, only the setting of
sufficiently strict environmental quality standards allows to check whether, across the EU,
surface and groundwater pollution levels remain below concentrations harmful to the
environment and/or human health – subject to proper monitoring and implementation by MS.
The potential for long-term and irreversible risks to ecosystems and human health from
emerging contaminants necessitates EU measures to halt the bioaccumulation and limit health
risks. While some of these pollutants can in part be addressed through end-of-pipe measures
(such as the UWWTD), upstream solutions are also essential to limit pollutant emissions and
to avoid passing the bill for treatment to the end-user. This is particularly important
considering that Article 7(3) of the WFD (protection of areas used for the abstraction of
drinking water), is ‘under-implemented’ and necessitates drinking water and urban waste
water treatment plant operators to deploy costly treatment methods.
Measures to be taken to reduce the presence of the listed pollutants are often a combination of
EU (e.g. EU product bans or operating standards) and local action (e.g. industrial emission
limits or waste water plant operating conditions adjusted to local circumstances). Addressing
pollution without action at international level would in many cases be prohibitively
expensive, especially for downstream countries. Therefore, action at EU level is of
paramount importance. 60% of European river basin districts are international (either shared
between MS or between a MS and a 3rd
country) and the WFD made cooperation between
countries sharing a basin within the EU mandatory. Pollution often finds its source in part or
entirely in one country, making international cooperation essential to reduce pollution in a
cost-efficient manner. Substances listed under the legislation automatically become part of
the mandatory cooperation (for intra-EU river basins) or of the “endeavours” (for river basins
shared with non-EU countries) MS are required to make according to WFD Article 13.
A failure to address risks from emerging pollutants swiftly via EU wide quality standards can
lead to incorrect risk assessments for groups of substances regulated at EU level. This also
leads to an underestimation of human health and environmental risks associated to certain
31
groups of substances of very high concern. Finally, if unaddressed, the cumbersome reporting
and a lack of data sharing between different legislative areas and between countries will
continue to lead to potentially delayed and inefficient policy measures.
Box 7: Views on the relevance of EU water legislation expressed during consultation activities
OPC respondents considered the water directives and regulations highly relevant for environmental protection (average
score of 4.2 on a scale from 1 – not at all – to 5 – very much), agriculture sector, wastewater treatment and health
protection (each scored at 4.1), and biodiversity protection (4.0), with the relevance deemed highest at EU level (4.3) for
all these areas. Overall, the directives were not seen as relevant for the circular economy (3.6), particularly at a local level
(3.3).
3.3 3.3 Subsidiarity: Added value of EU action
The 2019 FC of EU water legislation confirmed the added value of the WFD, EQSD and
GWD. The Directives have triggered or reinforced action at European level to address the
transboundary pressures on water resources at river basin level, both nationally and
internationally. Experts interviewed during the FC consultation highlighted the power of a
long-term binding policy target and the fact that the Directives’ level of ambition is higher
than what could have been expected without them. Additionally, stakeholders consulted for
this Impact Assessment considered imposing stringent standards at EU level to be more
effective in addressing surface and groundwater pollution than action at national level (see
Box 8).
Box 8: Views on effective strategies to address surface and groundwater pollution expressed during consultation
activities
During the OPC, stakeholders were asked to rate from 1 (not at all) to 5 (very much) the effectiveness of certain strategies
in addressing surface and groundwater pollution. “Regulation of the application and use of pesticides and biocides”
(average rating of 4.3, rated ≥4 by 74% of respondents) was considered to be the most effective, closely followed by
“Regulations at EU level to ensure pollutant presence and exceedance are minimised through stringent standards”,
“Regulation of emissions from UWWTPs” and “Point source-based pollution control through regulation (legally binding)”
(average rating of 4.2, rated ≥4 by 79%, 74% and 72% of respondents respectively). “Regulations at MS level to ensure
pollutant presence and exceedance are minimised through stringent standards” were viewed to be less effective (average
rating of 4.0, rated ≥4 by 68%)..
Specifically in relation to pollutants, the legislation distinguishes between substances most
appropriately legislated at EU level and those to be regulated at river basin or groundwater
basin level. The substances considered for addition to the pollutant lists belong to the first
category as they raise an EU-wide concern (see Chapter 5.1.1 for explanation of how these
are selected). This revision process also identified a small number of existing PS that are no
longer considered substances of EU-wide concern, but which might still need to be addressed
at national level as (RBSPs). Those substances are covered under surface water policy option
4 (possible deselection). For the latter, it supports a mechanism transferring former EU EQSs
to an EU-wide repository of standards, to be applied if the substances are identified as
RBSPs, to safeguard a harmonised approach to the extent possible, and thus contribute to
maintaining a level playing field between MSs.
Market authorisation and risk assessment of many of the substances concerned takes place at
EU level (e.g. pharmaceuticals, pesticides, industrial chemicals) even if national procedures
co-exist, providing for a harmonised and cost-efficient approach, as well as a level playing
field to those who sell and use the substances.
32
4 4 OBJECTIVES: WHAT IS TO BE ACHIEVED?
Having regard to the accelerated need to reduce the presence of toxic chemicals in water in
light of the on-going triple planetary crisis (climate change, biodiversity and pollution), the
aim of this regulatory intervention is to update the lists of substances and their quality
standards set in the Annexes of the EQSD and GWD,whilst clarifying their importance for
future drafting and assessments of RBMPs and modernising the modalities to keep them in
pace with scientific and technological developments. .
4.1 4.1 General objectives
Taking into account the overarching objective of EU water policy, the general objectives of
this initiative are to increase the protection of EU citizens and natural ecosystems in line
with the Biodiversity Strategy and the Zero Pollution ambition embedded in the European
Green Deal, and to increase effectiveness and reduce administrative burden of the
legislation, hence facilitating a quicker response to emerging risks. Both of these are long-
term aims that will see limited positive progress without further action under EU water
legislation. Whilst implementation of other EU and international policies can and will
contribute to lowering the emerging risks to or via the aquatic environment (see dynamic
baseline assessment in section 0 and Annex 4), none of the other initiatives can guarantee an
adequate level of protection is achieved, hence rendering action under EU water legislation
essential.
4.2 4.2 Specific objectives
The specific objectives represent the short-to-medium-term goals set to achieve the general
objectives of this revision, and bring closer the overall aim of EU water legislation described
above. The planned EU intervention would have the following specific objectives:
1. Align the lists of pollutants affecting surface and groundwater with the latest scientific
knowledge.
2. Improve monitoring of the state and evolution of surface and groundwater pollution to
gather more comprehensive evidence for future risk assessments.
3. Harmonise the ways pollutants in surface and groundwater are classified and tackled.
4. Provide a legal framework that can be more swiftly and easily aligned with science and
promptly respond to contaminants of emerging concern.
5. Improve transparency and access to data, thereby facilitating implementation (also of
existing quality standards) in the MS, as well as reducing administrative burden.
Because these objectives aim to address specific shortcomings of the WFD, EQSD and GWD
identified by the Fitness Check, they will not be influenced by other policy initiatives
considered under the dynamic baseline (see section 0 and Annex 4).
5 5 WHAT ARE THE AVAILABLE POLICY OPTIONS?
The policy options were derived taking into account the identified problems and objectives as
described in Chapters 2 and 4, respectively. The intervention logic, introduced in Chapter 2,
explains how the main options are expected to address the problems, their drivers and
consequences while delivering on the specific objectives.
33
This chapter outlines the methodology used to select candidate substances and set their
quality standards (QS), describes the baseline in case of no legislative action in the field of
water policy, and presents the policy options identified for consideration.
5.1 5.1 Methodology to select substances and set the quality standards
This section summarises the key elements of the technical processes carried out to prioritise
substances for listing under EU water legislation and derive their respective QSs. Further
details can be found in Annexes 4 and 5 of this impact assessment.
5.1.1 5.1.1 Substance selection
Identification of new substances to consider listing is based on the risk to or via the aquatic
environment. The risk assessment follows the criteria set out in WFD Article 16(2) and
includes, as a minimum, weighing of:
 the intrinsic hazard of the substance concerned, and in particular its aquatic
ecotoxicity and human toxicity via aquatic exposure routes;
 evidence from monitoring of widespread environmental contamination; and
 other proven factors indicating the possibility of wide-spread environmental
contamination, such as production / use volumes of a substance, and use patterns.
The prioritisation process for surface water serves as a basis for the determination of
substances either to be selected as candidate PS, RBSPs or for inclusion on the SW WL.
Introduced by the amendment of EQSD in 2013, the SW WL has so far resulted in the
adoption of three Commission implementing decisions establishing a list of substances for
Union-wide monitoring in the field of water policy. Under the SW WL, emerging substances
are monitored at selected EU representative monitoring stations for at least 12 months, and up
to 4 years. Monitoring data for pollutants listed in the first two Commission implementing
decisions have been used to derive the candidate PS list for this initiative. The candidate PS
indicate the pollutants for which an EU-wide risk has been established, warranting an EQS
derivation and impact assessment. This process resulted in 24 individual substances and a
group of 24 PFAS being selected.
There is an urgent need to address microplastics at source in view of the ever increasing loads
of microplastics in EU surface and groundwater. A ban on the intentional use of microplastics
in products, including fertilisers, cosmetics, detergents would prevent the release of 500,000
tonnes of microplastics into the environment over a 20-year period. Because of that,
microplastics were considered but were not taken further as candidate PS because there is too
little data to perform an actual risk assessment. Consequently, gaps in relation to the
measurement, monitoring and data collection of the actual concentrations of microplastics in
surface and groundwaters need to be addressed first, to allow setting an actual EQS in a
second stage.
The prioritisation process for groundwater serves as a basis for the determination of
substances to be selected either for the voluntary Groundwater Watch List (GW WL), or for
the List Facilitating the Review (LFR) of Annexes I and II of the GWD. The GW WL
provides a list of substances that MS should consider adding to their monitoring programmes
on the basis that these pollutants may present an obstacle to the achievement of the
34
environmental objectives of the WFD. This is key to obtaining data for new or emerging
pollutants, feeding into the development of the GWD. Under the umbrella of the Working
Group Groundwater (WG GW), the sub-group on the voluntary GW WL has contributed to
assessing data provided by the participating countries and the subsequent compilation of the
LFR for this initiative. Pollutants on the LFR go through the quality standard derivation
process as described below and are then included in the impact assessment. The process
resulted in a group of 10 PFAS, 2 individual pharmaceuticals and a group of 16 nrM
substances being selected (22).
It should be stressed that the prioritisation of substances for listing is based on the conclusion
that they pose a risk at EU level, i.e. in all or most MS. The monitoring required as a result of
the substances proposed for listing will inform future revisions of the lists. In this context, it
should also be noted that the initiative considers various improvements to the monitoring
regime (see Section 5.2.3), thereby improving future data availability.
5.1.2 5.1.2 Setting the limit values
The derivation of quality standards for selected substances (or ‘quality standards derivation
process’) follows scientific methods and is subject to several rounds of scrutiny, as illustrated
in Figure 5.1.1. The technical process of threshold derivation for surface and groundwater
pollutants is carried out by the JRC in collaboration with subgroups of experts and
rapporteurs. The approach used to set the limit values for candidate PS is based on a
Technical Guidance Document on Deriving EQS (53) developed in 2018. It starts with
collecting (eco)toxicity data from EU official reports, stakeholder inputs and peer-reviewed
studies. Then the scientific papers are evaluated for reliability and a selection of critical data
for EQS derivation is made. For substances on the LFR of the GWD, the QSs are drafted
considering specificity of groundwater ecosystems, any national threshold values (TVs) set
by MS, links with the Drinking Water Directive and EQS set for surface water.
35
Figure 5.1.1: Process of setting limit values for surface water and groundwater
pollutants
The support studies and draft quality standards are subject to quality control and validation by
the experts of Common Implementation Strategy (CIS) working groups (WG). Comments
received are addressed by the JRC and the derived QSs are submitted for an independent
review by the Scientific Committee on Health, Environmental and Emerging Risks
(SCHEER). The SCHEER considers whether the EQS have been correctly and appropriately
derived, in the light of the available information and the TGD-EQS; and whether the most
critical EQS (in terms of impact on environment/health) has been correctly identified. Values
endorsed by the SCHEER are used in the impact assessment and the legislative proposal. The
impact assessment incorporates the preliminary or final opinions on each of the substances /
groups of substances, available at this point in time (September 2022). QS for substances for
which no preliminary or final opinions are available, are based on the dossier prepared by the
Commission for SCHEER. The QS for these substances are denoted by square brackets
throughout the Impact Assessment and the Proposal. As opinions arrive, square brackets will
be removed.
What is the baseline from which options are assessed?
The baseline describes a situation where no further changes would be introduced in policies
directly affecting EU water quality (i.e. the WFD, EQSD and GWD). In designing the
baseline, it is assumed that the identified problems would remain, although their scale would
be impacted by external trends influenced by existing and upcoming policy interventions (e.g.
possible chemical substitution of a banned substance) and other non-policy drivers (e.g.
demographic developments). The dynamic baseline therefore reflects the likely changes to
emissions and, by proxy, environmental concentrations in a “business-as-usual” scenario.
To understand how the policy landscape will change the baseline situation, each candidate
substance was assessed against each relevant EU and international policy instrument,
indicating the expected range of impact on emissions. The outcome of this exercise is
provided in Table 5.1.1.
For many of the substances, efforts are already being made under other legislation which
might have a beneficial impact for the aquatic environment. This includes initiatives like the
review of the industrial emissions directive (IED) and the UWWTD, as well as upcoming EU
initiatives on micro-plastics and PFAS. The most significant of these is for PFAS, which have
been a core focus within the EU Green Deal and are reflected across a basket of legislation
(most notably the upcoming REACH initiative to ban non-essential uses). The
Pharmaceutical Strategy should address issues with many pharmaceuticals, however, for non-
prescription medicines like ibuprofen data gaps are larger and controls look weaker,
suggesting emissions will continue to grow in line with affluence, availability, and an ageing
population. The continuous implementation of the existing Programmes of Measures (PoMs)
under the WFD as well as the target under Farm to Fork Strategy to limit use of hazardous
pesticides will likely reduce pesticide releases to the environment. These could have
synergistic benefits for the candidate PS that are pesticides and their non-relevant
metabolites. Only five parent pesticides of the 16 nrMs listed in the LFR are still authorised:
glyphosate, metazachlor, flufenacet, dimethachlor, and fluopicolide. The bans already in
place for the other parent pesticides of the remaining nrMs are expected to entail, over time,
36
significant reductions in the concentrations of nrMs in groundwater. A detailed overview of
the dynamic baseline and the expected contribution of EU initiatives for pollutants is
included in Tables A4.1 and A4.2 in Annex 4.
For four candidate PSs as well as five substances considered for EQS amendment, no
significant decrease or increase in emissions (+/- ≤10%) was found, even in the presence of
other key policies aiming to drive down emissions. The ‘no change’ outcome is the product
of complex issues, such as multiple pathways to the environment, other drivers, or legacy
issues which are likely to prevent real change in emissions to water before 2030 and therefore
necessitating additional measures by MS if their water bodies fail to meet the standards set.
For all five existing PS that have been proposed for deselection, the baseline is also
considered to be no change in the current situation. This is because three of these chemicals
are banned for many years, and emissions of the other two appear to be stable for years.
Table 5.1.1: Outcomes of the dynamic baseline assessment
Policy option
Significant reduction
(30% - ≤50%)
Some reduction
(10% - ≤30%)
No change
(≤10%)
Substances
considered for
addition to PS
list / GWD
Annexes
Pharmaceuticals:
Macrolide antibiotics
(azithromycin,
clarithromycin,
erythromycin)
Industrial chemicals:
PFAS
Pharmaceuticals: Diclofenac,
Carbamazepine, estrogenic hormones
(E1, E2, EE2)
Pesticides: Neonicotinoids
(Acetamiprid, Clothianidin,
Imidacloprid, Thiacloprid,
Thiamethoxam), Pyrethroids
(Bifenthrin, Deltamethrin,
Esfenvalerate, Permethrin),
Nicosulfuron, nrMs
Industrial chemicals: Microplastics
Metals: Silver
Pharmaceuticals: Ibuprofen
Pesticides: Triclosan,
Glyphosate
Industrial chemicals:
Bisphenol A
Substances
considered for
amendment of
existing EQS
Metals: Mercury
Pesticides: Chlorpyrifos, Cypermethrin,
Diuron, Tributyltin
Industrial chemicals: PAHs,
Nonylphenol, PBDEs
Metals: Nickel
Pesticides: Dicofol,
Heptachlor / Heptachlor
oxide, Hexachlorobenzene
Industrial chemicals:
Dioxins, Fluoranthene,
Hexachlorobutadiene,
HBCDD
Substances
considered for
deselection from
PS list
Pesticides: Alachlor,
Chlorfenvinphos, Simazine
Industrial chemicals:
Carbon tetrachloride and
Trichlorobenzenes
Note: Baseline assessment does not account for the revisions of the UWWTD and SSD as
these were premature at the time of analysis.
The dynamic baseline reflects emission rates to water and does not consider the persistence or
residence time in different environmental compartments, which would have a further impact
on ambient concentrations. Furthermore, physical properties and environmental fate will vary
substance by substance, adding uncertainty to this analysis. However, consideration of
emission control under existing or upcoming policy interventions helps understand whether
we could expect the ambient concentrations in water to go up, down, or remain broadly
similar to current levels.
37
5.2 5.2 Description of the policy options
5.2.1 5.2.1 Surface water policy options
Based on the problem definition for surface water and to address specific objective 1 of this
initiative, a total of four policy options were identified (listed in Table 5.2.1 below) that add
substances to the existing PS list, change environmental quality standards or deselect
(remove) currently listed substances. Policy options 1 and 2 focus on the listing of new
candidate substances, i.e. if and how (e.g. individually or as groups39
) they should be listed,
therefore constituting an “either-or” selection as they represent different approaches for the
same candidate substances. Policy options 3 and 4, on the other hand, are independent of all
other options and the choice there is only whether, for each of the substances involved, the
respective option should be implemented. The recommended EQSs for each substance or
group of substances under Options 1, 2 and 3 are listed in Annex 8.
When looking at possible policy measures to address substances that are included in the
substance lists under the Directive, it is important to differentiate between PS and priority
hazardous substances (PHS) since the regime of possible measures is different. Measures for
PS are mainly aimed at reducing emissions in view of complying with the EQS values,
whereas measures for PHS are aimed at phasing out emissions entirely. From all the
candidate substances under consideration, only PFAS and Bisphenol A (BPA) meet the
criteria for PHS status.
Table 5.2.1: Surface water policy options
Policy
option
Description List of substances
Policy
option 1:
Additions. Include each candidate priority
substance individually and set
corresponding individual EQS.
Pharmaceuticals: 17-alpha-ethinyl-estradiol (EE2), 17–beta-
estradiol (E2), estrone (E1), Azithromycin, Erythromycin,
Clarithromycin, Diclofenac, Carbamazepine, Ibuprofen
Pesticides: Nicosulfuron, Acetamiprid, Clothianidin,
Imidacloprid, Thiacloprid, Thiamethoxam, Bifenthrin,
Esfenvalerate, Deltamethrin, Permethrin, Glyphosate,
Triclosan
Industrial chemicals: 24 PFAS, Bisphenol A (BPA)
Metals: Silver and its compounds
Other: microplastics
Note: only PFAS and BPA meet the criteria for designation
as PHS.
Policy
option 2:
Additions. Include candidate priority
substances as groups of substances where
appropriate. Set corresponding EQS using
markers or the sum of substance
concentrations in the case of groups.
Policy
option 3:
Amendments. Revise EQS where necessary
based on new scientific data for existing
priority substances.
Pesticides: Chlorpyrifos, Cypermethrin, Diuron, Dicofol,
Hexachlorobenzene, Heptachlor/Heptachlor epoxide
Industrial chemicals: Dioxins, Fluoranthene,
Hexabromocyclododecane, Hexachlorobutadiene, Nonyl
phenol, PAHs (consisting of following 5 PAHs:
Benzo(a)pyrene (marker for other compounds);
Benzo(b)fluoranthene; Benzo(k)fluoranthene;
Benzo(g,h,i)perylene; Indeno(1,2,3-CD)pyrene), PBDEs,
Tributyltin
Metals: Mercury, Nickel
Policy
Option 4:
Deselection. Remove substances from the
list following agreed deselection criteria.
Pesticides: Alachlor, Chlorfenvinphos, Simazine
Industrial chemicals: Carbon tetrachloride and
39
This covered the possible grouping of the three estrogenic substances, three macrolide antibiotics, five neonicotinoid pesticides, four
pyrethroid pesticides and 24 PFAS substances. Also including pesticides as a group in surface waters is considered as part of option 2, with
a group standard of 0.5 μg/l, i.e. corresponding to that in the GWD and the DWD.
38
Policy
option
Description List of substances
Trichlorobenzenes
It should be noted that the legislation currently provides MS with a period of time to comply
with the newly listed substances and the modified TVs, going beyond the 2027 deadline for
achieving good chemical status set in the WFD. For revised surface water EQS this additional
time was set40
at 6 years (2021, plus 12 more years in case of technical infeasibility or
disproportionate cost). For new surface water substances, it is 12 years (2027, plus 12 more
years in case of technical infeasibility or disproportionate cost).
Box 9: Views on surface water options expressed during consultation activities
Option 1: Overall agreement for including all candidate substances on the Priority Substance list, with ≥55% of TEC
respondents supporting listing PFAS, BPA, Diclofenac, Carbamazepine and Ibuprofen.
Option 2: Clear preference for PFAS and slight preference for macrolide antibiotics to be added as groups rather than
individually.
Option 3: More stringent EQS values were supported for Chlorpyrifos, Diuron (AA/MAC) and PAHs (biota); whereas
current AA/MAC EQS for Nickel and biota EQS for Mercury, Hexachlorobenzene and Hexachlorobutadiene were
considered correct. Views that EQS should be less stringent for Heptachlor/heptachlor epoxide (MAC) and PBDEs (biota)
were expressed.
Option 4: ≥50% of TEC respondents saw no EU-wide risk for Alachlor, Chlorfenvinphos and Simazine.
5.2.2 5.2.2 Groundwater policy options
Three policy options have been developed to address the pollution of groundwater by PFAS,
pharmaceuticals and nrMs. The major policy choice is whether to add these emerging
contaminants to Annex I (as individual substances or groups) or Annex II of the GWD.
Additions to Annex I must be accompanied by an EU-wide groundwater quality standard
(currently covered are nitrates, pesticides and their relevant metabolites), whilst substances
added to Annex II must be considered by MS during the risk assessment phase of river basin
management planning, and appropriate TVs set at national level.
The options, listed in Table 5.2.2, represent an “either-or” choice for each of the substances
(or groups of substances), which are assessed independently of each other under each option.
The SCHEER endorsed quality standards are based on available (eco)toxicological data,
harmonised with surface water quality standards in several cases, and, where necessary, the
precautionary principle. All of the options address specific objective 1 of this initiative.
Table 5.2.2: Groundwater policy options
Policy
option
Description List of substances
Policy
Option 1
Add LFR substances to GWD Annex I
individually or as a group of specific
chemicals, and assign an individual or
a “sum of” EU-wide GW QS
respectively.
Industrial chemicals: PFAS (Group of 24 as for surface water)
Pharmaceuticals: Carbamazepine and Sulfamethoxazole
Pesticides: All nrMs
Policy
Option 2
Add LFR substances to GWD Annex I
as groups of all, and assign an EU-
Industrial chemicals: All PFAS
All Pharmaceuticals
40
At the most recent revision, in 2013; for groundwater the current initiative is the first revision.
39
Policy
option
Description List of substances
wide GW QS for the group “total”. Pesticides: All nrMs
Policy
Option 3
Add LFR substances to GWD Annex
II for MS to consider setting a TV for
specific substances posing a risk to
groundwater bodies (GWBs).
Industrial chemicals: All PFAS
All Pharmaceuticals, Carbemazepine and Sulfamethoxazole are
included in the minimum list of pollutants (part B). Additionally,
as a guideline, a reference to the GWWL is added, which
includes nine pharmaceuticals
Pesticides: All nrMs
Box 10: Views on groundwater options expressed during consultation activities
PFAS addition to Annex I was most strongly supported in the targeted expert survey. Listing a limited number of named
PFAS was favoured by 49% of respondents, whereas 19% preferred including all PFAS with a group ‘total’ standard.
The general consensus for pharmaceuticals was to include them in Annex I (individually - 33% of TEC respondents; all as
a group – 18%). Annex II listing was favoured by 27% of respondents.
Most TEC participants endorsed inclusion of nrMs in Annex I (46% favoured listing a limited number of named nrMs
with individual QSs, whereas 13% preferred including all nrMs with a group ‘total’ standard). Annex II listing was
supported by 23% of respondents. Contrasting views on the quality standards were expressed during all consultation
activities, with industry stakeholders preferring less stringent QS, and MS and drinking water sector representatives noting
the widespread presence of nrMs in groundwater and urging stricter regulation at EU level.
5.2.3 5.2.3 Monitoring, reporting and administrative streamlining options
To address specific objectives 2 to 5 of this initiative, 15 discrete actions were identified.
These were categorised into four groups of policy options based on their subject matter (e.g.
monitoring, reporting) and nature (e.g. voluntary, legislative). Table 5.2.3 lists the four policy
options and the respective specific sub-options considered under each. The four thematic
policy options are not mutually exclusive and all the (sub)options can be implemented in
combination with each other within and across these groupings. All these (sub)options are
complement the surface and groundwater-specific options described above.
Providing / improving guidance and advice on monitoring, including Effect Based Methods
(EBMs), modern instruments, digital techniques etc., is necessary to address the significant
pressures stemming from emerging pollutants (such as microplastics) and possible
cumulative effects of pollutant mixtures. Regarding microplastics, no commonly agreed
standard for measuring their presence in EU freshwaters exists. Such a standard is, however,
a prerequisite for monitoring and taking targeted policy action like setting an EQS/GW QS.
In addition, there are a range of innovative monitoring techniques, including automated
sensing technologies, which could provide important insights into pollutant levels, but which
are yet to be commonly adopted. Improved sharing of knowledge and best-practices among
MS may help facilitate wider implementation of such innovative methods.
Establishing / amending existing obligatory monitoring practices is needed to gather more
specific evidence on the evolution of pollution. Mandatory monitoring would help fill the
existing data gaps (e.g. on the combined effects of estrogenic substances, emerging pollutants
in groundwater, seasonal variations of emissions in surface waters) and inform future risk
assessments.
Actions to harmonise / simplify reporting and classification would improve transparency and
access to data as well as reduce the administrative burden of MS in the medium and long
term.
40
Box 11: Which kind of information are stakeholders interested in?
During the OPC, the majority of respondents indicated a need for access to more information for all of the items listed in
the questionnaire (i.e. average rating ≥3.5 on a scale from 1 – not at all – to 5 – very much). Stakeholders expressed the
most interest (average score of 4.2) in information on the presence and concentration of individual/groups of pollutants
(rated ≥4 by 80% of respondents) as well as sources, nature and associated risks of pollutants (rated ≥4 by 79% of
respondents).
The legislative and administrative changes are needed to enable more effectiveness,
efficiency, coherence, responsiveness and flexibility in the legislation.
41
Table 5.2.3: Policy options related to monitoring, reporting and administrative streamlining
Policy
Option
Description List of sub-options
Objective
addressed
Policy
Option
1
Provide /
improve
guidance and
advice on
monitoring
a) Develop guidelines on applying innovative methods in monitoring procedures,
including continuous/automated monitoring techniques.
Specific
objective 2
b) Follow-up to improve existing guidelines on EBMS in view of setting application
‘trigger values’ in practice to improve monitoring of groups/mixtures of pollutants
by using EBMs, and trigger values.
c) Develop a harmonised measurement and monitoring methodology and guidance
for microplastics, as a basis for mandatory MS reporting on microplastics and a
future listing under EQSD/GWD.
Specific
objectives
2, 3
d) Develop guidelines on sampling frequency for PS and RBSPs.
Specific
objective 2
e) Provide a repository for sharing best practices from MS regarding available
monitoring techniques, and foster cooperation to implement these.
Policy
Option
2
Establish /
amend
obligatory
monitoring
practices
a) Include an obligation in the EQSD to use EBMs to monitor estrogens.
b) Establish an obligatory GW WL mechanism analogous to that for surface waters41
and drinking water, and provide guidance as necessary on the monitoring of the
listed substances.
Specific
objectives
2, 3
c) Improve the monitoring and review cycle of the SW WL so that there is more time
to process the data before revising the list.
Suggested improvements consist of a) increasing the monitoring frequency for
pollutants with seasonal emission patterns (e.g. pesticides); b) extending the
obligatory monitoring period from 12 to 24 months; and c) increasing the review
frequency from 24 to 36 months (by modifying WFD Article 8b).
Specific
objective 2
Policy
Option
3
Harmonise /
simplify
reporting and
classification
a) Establish an automated data delivery mechanism for the EQSD and the WFD to
ensure easy access at short intervals to monitoring/status data to streamline and
reduce efforts associated with current reporting, and to allow access to raw
monitoring data.
Specific
objective 5
b) Introduce a reference list (repository of standards) of EQS for RBSPs as an annex
to the EQSD and modify Annex V of WFD section 1.2.6 (Procedure for the setting
of chemical quality standards by MS) accordingly, and incorporate RBSPs into the
assessment of chemical status for surface waters
Specific
objectives
3, 5
Policy
Option
4
Legislative
and
administrative
aspects
a) Use an annex in the EQSD instead of Annex X to the WFD to define the list of PS,
and update the lists of SW and GW substances by Comitology or delegated acts.
Specific
objective 4
b) Change the status of the ‘eight other pollutants’ added to the EQSD from the
former Dangerous Substances Directive (76/464/EEC) to that of PS/PHS.
Pesticides: Aldrin, Dieldrin, Endrin, Isodrin, DDT (all to PHS); Industrial chemicals:
Tetrachloroethylene, Trichloroethylene (to PHS), Carbon tetrachloride
Specific
objective 3
c) Change the status of some existing PS to that of PHS where it fulfils the criteria of
the POP Regulation and/or Article 57 of REACH Regulation.
Industrial chemicals: 1,2-Dichloroethane, Fluoranthene, Octylphenol,
Pentachlorophenol; Metals: Lead
Specific
objective 1
41
The maximum number of substances that can be included for monitoring might differ for the surface and the groundwater watch lists.
EN EN
5.3 5.3 Options discarded at an early stage
For the identification of possible policy measures, a two-step approach was used. In a first
step, a wide range of possible measures were identified. For each problem, different solutions
were envisaged, ranging from soft approaches - mainly based on non-binding guidance to MS
- up to stricter regulatory measures. In a second step, based on a 'feasibility’ screening, a
selected number of possible policy measures were retained for further analysis.
The option of not updating other aspects of this legislation that are not directly linked to
chemical pollution was discarded early on, given the outcomes of the FC and the political
commitment not to seek a change in the WFD in the short run. Also rejected was the option
in relation to targeted substances to directly ban certain pharmaceuticals, pesticides or other
chemicals. In all these cases the EU has a well-functioning system of risk-screening before
market authorisation for their intended use. Therefore, while possibly effective from an
environmental standpoint, these options would be inconsistent with the established policy
approaches. As regards substitutes for potential new substances, the impact assessment did
not consider substitutes that are over 3.5 times more costly than the original substance, as
beyond this price difference they are no longer regarded as a realistic substitute (substitutes
considered are detailed in Annex 10).
6 6 WHAT ARE THE IMPACTS OF THE POLICY OPTIONS AND WHO WILL BE AFFECTED?
This section describes the impact assessment methodology, discusses the impacts of policy
options and stakeholders particularly affected by them. The assessment of the addition or
removal of substances or groups of substances selected through the methodology described in
Chapter 5.1 has been based on the distance to target, including application of the dynamic
baseline, and an assessment of additional measures that might be needed to achieve the
recommended quality standards (listed in Annex 8).
Note that EU water legislation does not specify exact measures to be taken to reach a given
water quality standard. Therefore, the assessment of possible costs and benefits of policy
options is based on the potential measures that MS might take because of this initiative,
additionally to the existing measures and any requirements imposed by other EU
legislation.
It is not possible, in this impact assessment, to identify the isolated cost and benefit of listing
substances since this will depend on measures chosen by MS and on distance to target in the
concerned water bodies. Moreover, water legislation works in sync with other legislation
(waste water treatment, source control, international requirements, etc). Figures in this
section and in section 8 are therefore often related to estimated costs / benefits from groups of
substances with similar characteristics or effect (eg cost of removing all PFAS, or all health
effects of hormone disturbing chemicals) but are not to be understood as costs and benefits
solely associated with this initiative.
A more detailed overview of impacts, for each of the surface water and groundwater options,
can be found in Annex 9.
EN EN
Box 12: Implications of listing a substance under the water legislation
For surface water, MS might need to:
 Monitor concentrations to obtain representative information of the water body and its chemical status.
 In case of EQS exceedances MS must act (source control measures take priority over others).
 If a substance is persistent, mobile and toxic (PMT) and/or very persistent, very mobile (vPvM) and thus also bio-
accumulates, then it is classified as priority hazardous substance (PHS).
 For priority substances (PS) MS must implement measures to progressively reduce pollution, for PHS MS must implement
measures to cease or phase out emissions completely.
 Include new substances in the national inventory of emissions, containing a timetable for cessation or phase-out, and
reduction.
For groundwater, MS might need to:
 Implement measures necessary to lower concentrations of any pollutant in groundwater and therefore progressively reduce
pollution.
 Take all measures necessary to prevent inputs into groundwater of any hazardous substances covered by the groundwater
quality standards in Annexes I and II of the GWD.
6.1 6.1 Impact assessment methodology
6.1.1 6.1.1 Distance to target
An important factor to understand the impacts of adding new substances to the lists of
pollutants or amending existing EQS values is the ‘distance to target’. This refers to the size
of the gap between the baseline situation and the target considered within the policy option.
The indicative assessment of the potential exceedances above the envisaged limit values
helps evaluate the likely extent of measures required to address the issue.
The ‘distance to target’ assessment followed a two-step process. First, the substances
considered under each option were assigned to groups (large / medium / small) based on the
predicted geographic scale (i.e. how many water bodies might fail chemical status; how many
MS might need to take measures) and the magnitude (i.e. how far above the thresholds do
concentrations rise) of the current gap. The general criteria for these groupings is shown in
Table 6.1.1 with further caveats (e.g. specificities for SW and GW assessment) explained in
Annex 4.
Table 6.1.1: General scale and magnitude criteria for the distance to target
assessment
Distance to
target group
Scale criteria (based on monitoring data)
Magnitude criteria (based on exceedances
compared to new quality standards)
Small Predicted exceedances in ≤33% of MS
Mean monitored concentrations ≥0 and ≤33% over the
new QS
Medium Predicted exceedances in >33 and ≤66% of MS
Mean monitored concentrations >33 and ≤66% over
the new QS
Large Predicted exceedances in >66% of MS
Mean monitored concentrations >66% over the new
QS
There is currently not enough detailed information to allow the distance to target to be
determined for each Member State vis-à-vis each substance or group of substances under
consideration. Indeed, the monitoring data underpinning such measurement (typically
gathered from the SW WL, the GW WL and the WFD reporting) are in a number of cases
incomplete. In such cases, extrapolation considering authorisation, use and emission data, and
EN EN
expert judgement are used to obtain an indication of the existing scale and magnitude of
pollution (see Annex 4 for details).
Secondly, the dynamic baseline assessment (described in Chapter 0) was taken into account
to reflect the expected change in emissions due to other (policy) drivers. The final distance to
target, therefore, reflects the additional EU-wide effort that may be required to tackle
the pollution caused by the candidate substances. Where there are no EU-wide measures
introduced by other policy initiatives, MS will have to take action nationally, and the (large /
medium / small) distance to target indicates the average relative effort required to tackle the
relevant substances. Results of the distance to target assessment are presented in dedicated
surface and groundwater sections below.
6.1.1.1 Surface water
The distance to target for surface water Option 1 (addition to PS list individually) and Option
2 (addition to PS list as groups) has been determined using a combination of monitoring data
gathered from the SW WL and the assessment conducted within the EQS dossiers. The
baseline situation is represented by the current concentrations measured in surface water,
whereas the target is the value considered protective of human health and the aquatic
ecosystem (i.e. the scientifically recommended EQS; see Annex 8).
An overall relatively large distance to target was estimated for 3 pharmaceuticals (17 alpha-
ethinylestradiol (EE2), Diclofenac, Carbamazepine), Silver, 5 pesticides (Bifenthrin,
Deltamethrin, Esfenvalerate, Permethrin, Glyphosate) and 2 industrial chemicals (PFAS,
Bisphenol A).
An overall medium distance to target was estimated for 4 pharmaceuticals (17 beta-estradiol
(E2), Estrone (E1), Azithromycin, Ibuprofen), 2 pesticides (Imidacloprid and Triclosan) and
1 metal (silver and its compounds).
An overall small distance to target was estimated for 2 pharmaceuticals (Clarithromycin,
Erythromycin), and 5 pesticides (Acetamiprid, Clothianidin, Thiacloprid, Thiamethoxam and
Nicosulfuron).
A slightly amended approach was used to assess the distance to target for surface water
Option 3 (EQS amendment), because the impact assessment looked at possible additional
efforts required to tackle these substances once their EQS is amended. The baseline situation
is, therefore, represented by the current gap between concentrations measured in surface
water and existing EQS, whereas the target is the new scientifically recommended EQS.
The scale and magnitude of the current gap has been determined using a combination of
monitoring data gathered from the WFD reporting and the assessment conducted within the
EQS dossiers. Then, based on the new recommended EQS (where available, see Annex 8)
and guidance from the JRC, an assessment has been made as to whether the size of the gap
would increase, decrease, or stay the same following EQS amendment. Afterwards, as for
other policy options, the impacts of the dynamic baseline (see Chapter 0) were taken into
account to re-group substances.
An overall relatively large distance to target was estimated for 1 industrial chemical group
(PBDEs) and 2 metals (Mercury, Nickel).
EN EN
An overall medium distance to target was estimated for 4 pesticides (Chlorpyrifos,
Cypermethrin, Diuron, Tributyltin) and 2 industrial chemical groups (Dioxins and furans,
PAHs).
An overall small distance to target was estimated for 3 pesticides (Dicofol, Heptachlor /
Heptachlor epoxide, Hexachlorobenzene) and 3 industrial chemicals (Fluoranthene,
Hexachlorobutadiene, Nonylphenol).
6.1.1.2 Groundwater
Unlike the surface water situation, an EU-wide monitoring network of emerging groundwater
pollutants does not exist. Therefore, the likely current day status of groundwater bodies
(GWBs) with respect to the LFR pollutants is needed to understand how much effort might
be required to reach the targets proposed by the various policy options. This baseline
assessment was made by reviewing the most recent reported status of GWBs (i.e. 2nd
River
Basin Management Plans covering the 2015-2021 period) and the chemicals leading to failure
with similar emission characteristics and environmental fate along pathways to groundwater.
The scale was represented by % of MS likely to report failure, whereas the magnitude was
defined as the level of exceedance above TVs already used by MS for the proxy substances.
Then, the expected distance to target was assessed based on expert judgement and the
indication of the likely level of exceedance over the potential PFAS, pharmaceuticals and
nrMs TVs. The level of exceedance is estimated by calculating the proportion of monitoring
locations and MS reporting concentrations above the targets stipulated in the policy options.
Afterwards, the impacts of the dynamic baseline (see Chapter 0) and the lag-time of
groundwater ecosystems were taken into account to adjust the grouping. For example,
although PFAS emissions are expected to reduce significantly due to other policy
interventions, this will be reflected in groundwater concentrations much later, therefore
having no impact on distance to target before 2030.
An overall relatively large distance to target was estimated for PFAS under all options as
well as nrMs under Option 1 (all individually in Annex I).
An overall medium distance to target was estimated for pharmaceuticals under Option 2
(group of all in Annex I), and nrMs under Option 2 and Option 3 (addition in Annex II).
An overall small distance to target was estimated for pharmaceuticals under Option 1
(carbamazepine and sulfamethoxazole in Annex I) and Option 3 (group in Annex II,
considering Primidone).
6.1.2 6.1.2 General considerations for all surface and groundwater options
Impacts of the policy options related to the (de)listing of surface water and groundwater
substances are dependent on the specific measures taken to reduce the presence of pollutants.
Measures come in four groups: source control (e.g. substitution, bans, emission prevention at
production stage), pathway disruption (physical barriers preventing/reducing pollution to
surface and ground-waters), end-of-pipe42
(in this case treatment measures
42
End-of-pipe treatment indicates the separate treatment of the generated pollutants before entering the environment. This usually occurs
either directly after the production process and/or after the use phase.
EN EN
preventing/reducing pollution at the waste water stage) and finally monitoring and risk
attenuation at water bodies’ level.
Key sectors likely to be impacted by groups of measures were identified. In many cases, the
same measures are effective for addressing multiple substances in a complementary fashion.
The importance of different measure categories varies depending on the substance. Table 6.1.2
provides a quick reference for how the measure categories relate to the substance categories.
Then, an overview of stakeholders possibly impacted by the implementation of identified
measures is presented in .
Table 6.1.2: Overview of measure categories and substance categories
Control Option Pharmaceuticals
Pesticides
Industrial
chemicals
Metals
Plant Protection
Products
Biocides
Intervention at source
    
Pathway disruption *  *** 
End-of-pipe    
Risk containment,
monitoring, and natural
attenuation
** 
*Relates to agricultural runoff from farmed animals only **Legacy uPBT pesticides only
***related to run-off from road only
Table 6.1.3: Overview of stakeholders likely impacted by measures identified (surface
and groundwater)
Pharmaceuticals Pesticides (incl. nrMs)
Industrial Chemicals
(incl. PFAS)
Metals
Pharmaceutical and Personal Care Products
manufacturers and distributors (ranging
from SMEs to multinationals) (EPR)
Pesticide manufacturers
and distributors
Manufacturing e.g. of
raw chemicals, clothing,
cosmetics textiles,
printing
Mining operations sector
Healthcare sector Healthcare sector
Manufacturing and use of
chemicals, disinfectants
(multiple sectors)
Manufacturing industries
– particularly smelting
and use in electronics /
automotive.
Farmers and veterinary applications –
farmed animals and horses
Farmers (ranging from
SMEs to multinationals)
and landowners
Infrastructure and roads
Healthcare sector e.g.
biocidal applications
Society - costs to consumers/
Veterinary applications –
particularly biocides,
farmed animals and
domestic pets
Society - costs to
consumers
Society - costs to
consumers
Wastewater and drinking water companies
(mainly SMEs)
Society - costs to
consumers
Wastewater and drinking
water companies (mainly
SMEs)
Wastewater and drinking
water companies (mainly
SMEs)
Member State Authorities – guidance and
enforcement
Wastewater companies
(biocides) (EPR) and
drinking water companies
Member State
Authorities – guidance
and permitting
Member State
Authorities – mine
drainage and landfill
EN EN
Pharmaceuticals Pesticides (incl. nrMs)
Industrial Chemicals
(incl. PFAS)
Metals
sites.
Member State Authorities
– guidance and
enforcement
Waste disposal (Landfill)
6.2 6.2 Surface water – impacts of policy options
This section provides a summary of the associated environmental, economic and social
impacts of individual policy options. The evaluations of the Industrial Emissions Directive
(IED) and the EU Pollution Release and Transfer Register (E-PRTR), pieces of legislation
with which the WFD interacts strongly, notably on water management, concluded that
industrial installations, covered by the IED /E-PRTR, account for about 20% of pollutant
emissions by mass to water this includes among others the main groups of pollutants covered
by this evaluation (pharmaceuticals, industrial substances, and metals). For pesticides the
picture is different since the main emitter of those substances is the agricultural sector who is
the end-user of the products produced by industry.
6.2.1 6.2.1 Policy option 1 – listing candidate PS individually
Option 1 applies to all substance categories (industrial/pharmaceuticals/pesticides/metals).
Industrial chemicals (PFAS and Bisphenol-A)
Important sources of PFAS emissions are the primary manufacturers of manufacturers of
fluorochemicals and/or fluoropolymers, as well as cardboard and paper mills producing
PFAS coated paper for a myriad of applications. The number of PFAS production sites in
Europe is between 12 and 25 plants (25). Also, based on Eurostat data on the basis of NACE
codes, nine additional industrial activities where PFAS are likely used (textiles, leather,
carpets, paper, paints and varnishes, cleaning products, metal treatments, car washes,
plastic/resins/rubber) were identified. Also, regarding environmental discharges from paper
mills, it is estimated that a “typical” paper mill that produces 825 tons of PFAS-coated paper
per day and discharges 98.4 million liters of water per day which release more than 100,000
ppt of PFAS in the wastewater effluent (55). Consequently, paper mill companies estimated a
release of 43 to 102 kg of PFAS per day in their wastewater43
. With 743 EU paper mills (56)
this results in daily PFAS emissions between 31 to 76 tonnes. Companies also state that for
10 kg of PFAS going from the manufacturing process into wastewater treatment, 9 kg end up
in biosolids and 1 kg is released into surface waters (57). That means the amount of PFAS
ending up in sludges across the EU ranges from 310 to 760 tonnes/day. PFAS can only be
effectively removed from wastewater by reverse osmosis with operating costs of €0.4 /litre. A
cost model calculating the capital costs for building PFAS drinking water remediation
resulted in baseline capital cost of $712,752 plus $2,070,142 per million gallons/day (MGD)
which is simplified to $2 million per MGD which equals €520/m3/day. Measures at source
would thus avoid costs at least €39.4 million EU-wide related to a complete removal of PFAS
43
Information obtained by EDF through a Freedom of Information Act request to the US Food and Drug Administration for PFAS used to
produce PFAS coated paper and board which is among others used for food contact applications.
EN EN
from paper mills effluents/sludges. Note: the EU has comparatively limited information on
(industrial) point sources of PFAS emissions from production and manufacturing sites
because many industrial installations do not have to monitor PFAS under their discharge
permits. Consequently, US information (58) (59) (60) (61) was used.
In 2018, a car wash facility in the US state of New Hampshire was cited as one of the sources
of PFAS contamination in wells serving several nearby towns (62). Investigators tested wells
on the car wash property and found levels for PFAS higher than expected – up to 158.8 ppt,
compared to the USEPA lifetime advisory level of 70 ppt. The facility will be required to
take measures to prevent the contamination from continuing. According to the International
Car Wash Association 79,000 car wash facilities are operating in Europe. These are likely to
be SMEs employing less than 250 workers (63). It is not known how many of these use
products containing PFAS.
The industrial chemical Bisphenol-A (BPA), is produced in large quantities for use primarily
in the production of polycarbonate plastics. It is found in various products including
shatterproof windows, eyewear, water bottles, and epoxy resins that coat some metal food
cans, bottle tops, and water supply pipes. For the environment, contaminated landfill leachate
is an important source for both SW and GW. Consequently, an improved capture of landfill
leachate combined with wastewater treatment could prevent in the order of 246MT of
leachate being emitted. Annual costs associated to this measure are estimated to amount
around €103.7 million, with an assumed 25-year asset lifetime. Avoided economic health
related costs for avoided BPA exposure in relation to childhood obesity are estimated to
amount to around €183144
million (64). Recent findings from EHCA (65) also support a
further restriction of BPA emissions. For human health, BPA in food and beverages accounts
for the majority of daily human exposure. BPA can leach into food from the protective
internal epoxy resin coatings of canned foods and from consumer products such as
polycarbonate tableware, food storage containers, water bottles, and baby bottles. Lowering
human health risks comes at little to no costs, since exposure can be easily limited by
behavioural changes such as not microwaving polycarbonate plastic food containers,
reducing the use of canned foods, and when possible, opt for glass, porcelain or stainless steel
containers, particularly for hot food or liquids and finally choosing to use (baby) bottles that
are BPA free.
Pharmaceuticals
Source control measures like restricting/reducing the use of candidate pharmaceuticals within
the human population, e.g. by substituting the most harmful pharmaceuticals by less harmful
alternatives (greening pharmacy), or by changing from over-the-counter to prescription-only
systems, will be important to limiting their emissions. Additionally, the management of
unused, expired medicines /medicine containers to prevent the substance entering wastewater
systems and/or landfills (see Box 13) could also be improved. Furthermore, new EU Ecolabel
criteria for cosmetics and animal-care products (adopted in October 2021) offer proof to
consumers that they purchase products with MSverified environmental excellence, along the
44
Based on an exchange rate of 1 EUR = 1.09 USD
EN EN
entire life cycle45
. Price impact for consumers will be limited since alternatives to listed
substances are available at little or no additional cost.
The use of pathway disruption measures like buffer strips (costs €160 per hectare) or natural
constructed wetlands (costs €43.7 per m3
) are identified as potential cost-effective measures
for reducing the entry of estrone (E1) and 17-beta estradiol (E2) into the environment. Under
a worst-case scenario, a maximum of 5% of all pastoral farmland would be assumed to
require measures (buffer strip /constructed wetland / additional fencing. End of pipe measures
directly relate to the revision of the UWWTD. The costs to remove micro-pollutants from
waste water under that legislation are shown in Table 6.2.1: Overview of measure categories
and substance categories.
Table 6.2.1: Overview of measure categories and substance categories
Preferred option in the UWWTD
revision SWD
Costs
(Million
€/year)
Toxic load
avoided (p.e.)
Avoided Toxic
load
in areas at risk
(p.e.)
Additional GHG (Million t
CO2e/year)
All plants >100 k p.e. + plants 10 k
to 100 k in areas at ’risk’46 1 185.51 68 198 41 836 0 to 4.97
As regards pharmaceuticals, depending on policy measures at national level, choice of
specific medication may be limited through different prescription policy.
For carbamazepine, diclofenac and ibuprofen a range of (cheaper) alternatives exist.
Technical challenges related to manufacturing and supply chains (increasing supply of
alternatives), and issues related to the prescription of alternatives exist for some substances.
Also, for specific individual patients the substitution of specific medicines might not be
feasible and could thus limit the impact on emission reductions. For veterinary uses, pathway
disruption could also help reduce diffuse emissions to surface water.
End of pipe measures to remove pharmaceuticals from waste water are relatively costly and
thus not preferred, but could be helpful for ibuprofen and carbamazepine. Ozonation could
help to remove macrolide antibiotics. Diclofenac is more costly to remove. The revision of
the UWWTD IA shows that the deployment of enhanced water treatment technology results
in considerable additional resource and energy costs (resulting in a significant increase of the
associated carbon footprint). Also, the undesired formation of bromide as unwanted
breakdown product is relevant for some substances. Annex 10 contains overview tables with
pharmaceutical substances, potential alternatives and the costs of each as well as tables with
an overview of the most common end-of-pipe measures and their cost per substance.
Increasing interest for surface and groundwater pollution by pharmaceuticals is fuelling
interest in developing new pharmaceuticals – or re-designing existing ones – to be more
environmentally friendly, or ‘benign by design.’ This includes drugs that are better absorbed
by the human body, or that biodegrade more rapidly in the environment. For example, by
structurally modifying propranolol – a commonly used and highly persistent beta blocker –
45
Currently, three out of four PCP sold in the EU display some kind of environmental claim or label, yet many of these claims are
untransparent about assessment criteria used, and/or difficult to understand or confusing for the consumer.
46
In this IA, it was assumed that 70% of facilities between 10 000 and 100 000 p.e. with a dilution rate of 10 or less would be considered as
‘at risk’- see UWWTD SWD Annex 4.
EN EN
researchers have been able to synthesise a derivative that breaks down much more easily in
the environment than its parent compound47
.
Green Pharmacy initiatives are already operating in a large number of MS. New Green
Pharmacy initiatives and actions, e.g. consisting of return schemes for unused and disposed
medicines, will expectedly strongly benefit SMEs and start-ups. Cost of those initiatives are
estimated to range between €1-10 million per MS. Local pharmacies / chemists and research
institutes are important players in such initiatives that boost innovation and employment
including in SMEs. In the pharmaceutical sector, SMEs drive innovation and play a major
role in the development of new medicines. More than 4 out of 10 medicines selected for
Environmental Medicine Agency priority medicines scheme were from SMEs48
. Therefore,
the push for substitutes will likely benefit those SMEs in the pharmaceutical sector.
In the cosmetics and personal care products sector, SMEs also play an important role. In 2020
France had 840 small and medium-sized enterprises (SMEs) specialized in the manufacturing
of cosmetic products followed by Italy (735), Poland (606), Spain (515), Germany (348)49
.
Also, the EU-funded research projects such as ‘Implementation of Research and Innovation
on Smart Systems Technologies’ (IRISS) have helped innovation and supported EU efforts to
extend competitive advantages of European research institutes and industry (e.g. the Institute
for Sustainable Chemistry, the Fraunhofer Institute, Starlab Barcelona, Siemens, Hitachi and
other partners) related to Smart Systems research e.g. to help reduce hazardous substances in
production in the textile and plastics industries (66). Such projects, illustrate that ‘Safe by
Design’ concepts increasingly find their way into politics and the chemical / pharmaceutical
and personal care products industry (67).
Pesticides
For pesticides, emissions are best limited by a combination of use restrictions, replacement
by less harmful alternatives, pathway disruption (e.g. buffer strips) and end-of-pipe measures.
The most important pathway to the (aquatic) environment is run-off from fields.
Consequently, on-farm measures are the most effective. Currently 1472 active substances,
safeners and synergists are registered in the EU pesticides database (68). This implies that
there are numerous approved authorised active substance that can be used to identify less
harmful substitutes to replace more harmful pesticides.
Less toxic chemical alternatives for pyrethroids are limited (often other pyrethroids). For
imidacloprid and triclosan (neonicotinoids) the primary uses relate to the use as a biocide and
associated losses to the aquatic environment often to sewer. Imidacloprid is used to controls
fleas and ticks in domestic pets. Primary chemical alternatives for imidacloprid are likely
pyrethroids, which may present some issues for certain animals sensitive to them (69).
Triclosan is mainly used in medicated soaps / disinfectants, for which substitution by less
harmful alternatives is realistic. Silver is commonly used as a substitute, but also has risks.
Annex 10 lists several pesticides, potential alternatives, and estimated costs of alternatives.
47
https://www.pharmaceutical-technology.com/comment/commentgreen-pharma-the-growing-demand-for-environmentally-friendly-drugs-
5937344/
48
https://www.ema.europa.eu/en/human-regulatory/overview/support-smes
49
https://www.statista.com/statistics/579043/number-of-smes-in-the-cosmetic-industry-in-europe-by-country/
EN EN
The use of physical barriers is not at saturation level in the EU yet and could thus be
envisaged by MS. Calculations undertaken to help derive indicative (orders of magnitude) of
costs attributed to the use of pathway disruption for pesticides is included in Annex 10.
Box 13: Implications of the Urban Wastewater Treatment Directive revision – advanced treatment to be applied over time
The impact assessment for the revision of the Urban Wastewater Treatment Directive looks amongst others at the the increasing
quantities and variety of micro pollutants (mainly pharmaceuticals). The impact assessment suggests a phased approach to
implementation of more advanced treatment, including:
 2025: setting up extended producer responsibility schemes.
 2030: identification of areas at risk (facilities from 10-100k people equivalent) and interim targets for facilities above
100k people equivalent.
 2035: all facilities greater than 100k people equivalent equipped with advanced treatment and interim targets for areas at
risk.
 2040: all facilities at risk equipped with advanced treatment.
For biocidal uses, particularly within indoor settings, the potential wash-off or rinsing to
drains during cleaning and maintenance is an issue. Consequently, end-of-pipe measures for
those specific uses can have an added value. Annex 10 provides the results of indicative cost
estimates for the removal of several substances in use as biocides. The IA for the revision of
the UWWTD indicates that ozonation could be reasonably cost effective to remove
imidacloprid. Removing triclosan requires reverse osmosis (RO) which is costly and
challenging to implement at local level. Removing Acetamiprid, Thiamethoxam, Permethrin
requires Granulated Activated Carbon (GAC) which is also expensive. Reverse osmosis
investment costs are estimated around €100,000 to €10,000,000 per plant, with operating
costs of €0.4 per dm3
(71). Also, RO results in an additional 20% water extraction needed to
prepare drinking water (due to the requirement for membrane flushing/cleaning), which will
add to existing water shortage pressure in many MS.
The main costs in relation to the reduction of pesticides in surface- and groundwater are
expected to be covered by the implementation of the revised legislation on the sustainable use
of pesticides directive (SUPD). According to the SUPD evaluation there have been no
remarkable drops in pesticide sales, or losses since 2009.
Reducing concentrations of pesticides and chemicals overall in GW and SW will reduce costs
of the drinking water purification sector, an important share of which are SMEs. SMEs are
for example active in monitoring and testing of (drinking) water and data analysis. EU wide
treatment costs amount to 510 million EUR per year. If, in line with the targets of the F2F
strategy, pesticide use is decreased by 50%, treatment costs decrease accordingly by 205
million/year. Corresponding costs savings for consumers are then around EUR 5-10 per
person/year (see Annex 3 for more details).
According to the progress report from the European Commission on the implementation of
the EU Pollinators initiative (72) the economic value of pollinating insects to crop production
in the EU is at least 3.7 billion EUR per year. New research shows pesticides are contributing
to the decline in pollinators. In particular the neonicotinoids are very toxic and persistent and
contribute to the loss of honeybees. Quite a number are known to be directly toxic for bees
and co-responsible for bee poisoning and bee death, like e.g. Imidacloprid, Clothianidin,
EN EN
Thiacloprid, Thiamethoxam, Dinotefuran, Nitenpyran, Fipronil, and Oleofin. Neonicotinoids
are extremely toxic to bees. LD50 rates (the rate at which half of the exposed population dies)
for clothianidin are 22-44 nanograms per bee for direct contact and 2.8-3.7 nanograms per
bee for oral ingestion. In other words, a single corn kernel with neonicotinoid seed treatment
potentially contains enough active ingredient to kill over 80,000 honey bees (73) (74). Some
scientific studies show that bumblebees exposed to neonicotinoids have at least 10% smaller
colonies than those not exposed to the insecticide, others report a 57% decline in
reproduction rates (75), with pesticide exposure having the greatest impact on nesting activity
and the number of offspring the bees produced. Assuming that between 10% or 50% of the
economic losses from pollinator decline are attributed to pesticide toxicity50
, this results in
mean annual benefits of EU and MS action on such pesticides (one of which is the current
proposal) from 370 million to 1.85 billion EUR (see Annex 3 for more details).
Pesticides users are almost exclusively SMEs (farmers, landscapers, etc). As regards the
production and production and marketing side, while a large number of SMEs are active here
as well (fastest growing segment companies with 50-250 employees, the sector is dominated
by very large companies, with 88% of the market share for the top 7 crop protection
companies in the EU51
. Impacts will depend heavily on the types of measures taken by MS to
ensure compliance with the legislation. If users need to revert to alternative pest management
methods or alternative pesticides this may lead to lower yields or higher costs. If the policy
measures lead to a drive for innovation, both SMEs and large companies on the development
and production side will profit.
Metals
For silver and its compounds, a myriad of sources and pathways to environment exist. For
anthropogenic activities like smelting, combustion of coal, manufacturing of silver containing
products, source control options consist of increased abatement and monitoring. Silver is used
widely as antibacterial agent in medicinal, personal care and other consumer products. The
widespread use of silver has already led to the release and accumulation of the AgNPs in
water and sediment, in soil and even, wastewater treatment plants (WWTPs) and is thus
impacting microbial communities in different environmental settings. Scientific evidence of
silver-driven co-selection of antibiotic resistance determinants is also numerous.
The resistance mechanism for nanosilver (NAg) is linked to indicated to increasing
environmental antibiotic resistance gene pools indicated by the many antibiotic resistance
genes already detected in samples from different environmental settings. These antimicrobial
resistance genes could ultimately find their ways to animals and humans. This is worrisome,
as the increasingly indiscriminate use of NAg could further promote the development of
silver resistance in bacteria. The bacterium ‘Acinetobacter baumannii’ (a bacterial pathogen)
was recently listed as the "number one" critical level priority pathogen because of the
significant rise of antibiotic resistance in this species52
. Currently, NAg still has proven
50
In the United Kingdom, 54% honeybee population lost in the last decades. In the US 30–40% disappearance of the honeybee colonies
attributed to colony collapse disorder.
51
Study supporting the REFIT Evaluation of the EU legislation on plant protection products and pesticides residues
52
Emerging Concern for Silver Nanoparticle Resistance in Acinetobacter baumannii and Other Bacteria; Oliver McNeilly, et.al, Frontiers in
Microbiology 16 April 2021, https://www.frontiersin.org/articles/10.3389/fmicb.2021.652863/full
EN EN
bactericidal activity towards this bacterium (A. Baumannii) even against strains that display
multi-drug resistance. Therefore, it is of utmost importance to avoid silver resistance
developing in this bacterium also in the light of scientific reports on heavy metal-driven co-
selection of antibiotic resistance. Consequently, the widespread use of NAg in commercially
available products promotes a prolonged microorganism exposure to bioavailable silver,
which enhances the advance of multi resistant bacteria / micro-organisms.
Finally, NAg and its transformed products are toxic to environmental microbes. Microbial
and gene abundance shifts are observed in various environmental settings. Physical and
chemical transformations of NAg can shift the diversity and abundance of microbes,
including those that are important in nitrogen cycles and decomposition of organic matters.
The combined ecological impacts of NAg call for a prudent use of silver and AgNPs and
minimising their water related emissions 53
.
Source control could include pre-treatment or onsite waste water treatment by reverse
osmosis (RO) prior to direct discharges or releases to sewer, amounting to an estimated cost
of 0.1% of the industry’s annual turnover54
. Alternatively, urban waste water treatment plants
would need to invest in reverse osmosis to clean such effluents. Assuming that between 1-5%
UWWTPs would have to deploy reverse osmosis, costs for EU taxpayers would be between
€2,184,600 and €109,230,000. Assuming the benefits of reducing silver related AMR to
equal between 50% to 100% of the AMR costs for antibiotics, this results in EU-benefits of
between €22 to €63 billion55
(2014 data, subsequently corrected for inflation between 2014
and 2021).
Pathway disruption measures consist of capturing and treating of mine drainage water before
it reaches water bodies. A targeted plan of action to tackle emission might be needed on a MS
by MS basis.
As detailed in Annex 9, table A9.1, the social impact of listing additional substances
mentioned in this paragraph concerns better protection of health in particular through
addressing the health and environmental effects of nanosilver, including the role of silver in
antimicrobial resistance, food security and ecosystem services such as avoided impact on
pollinators.
53
The impact of silver nanoparticles on microbial communities and antibiotic resistance determinants in the environment, Kevin Yonathan
et.al. Environmental Pollution 15 January 2022, 293: https://pubmed.ncbi.nlm.nih.gov/34793904/
54
An extrapolation of the RO costs based on the number of EU non-ferrous metals production facilities 84754
in 2019, assuming that around
5% - 10% of effluents need treatment, would potentially result in EU wide costs ranging from €423,500 to €8,470,000. In relation to the
annual turnover of the EU non-ferrous metals industry (120 billion54
) this would equal 0.1%.
55
Costs are converted using an average of USD 1 = EUR 0.75 for 2014, and then using an average inflation rate of 1.95% per year between
2014 and 2021, producing a cumulative price increase of 14.5%
EN EN
Box 14: Views on positive impacts of listing new PS expressed during consultation activities
When asked to estimate the significance of economic, health, social and environmental benefits / impacts resulting from the
inclusion of new candidate PS, the respondents generally found all impacts to be cumulatively positive (i.e. % selecting minor,
moderate or major benefit outweighed the % rating as ‘no benefit’). Benefits from improved surface water quality, lower risk
of damage to natural resources and benefits from improved environment and human health protection were valued most
(respectively 34%, 32% and 30% of respondents selecting ‘major’ benefits). The impacts of new candidate substances on the
quality of process water for agriculture and industry received the greatest number of ‘no benefit’ responses (16%). Impacts
regarding employment opportunities were identified as being largely unknown, indicated by the large share of ‘I do not know/no
opinion’ responses (57%).
6.2.2 6.2.2 Policy option 2 – listing candidate PS as a group
Under this policy option substances would be added under family groupings: PFAS56
,
estrogenic hormones, macrolide antibiotics, neonicotinoids and pyrethroids. This could limit
the burden on MS as well as disincentivise substitution with another similarly hazardous
substance in the same group. A group approach also helps better address overall cumulative
risks of substances with similar toxicity and modes of action and can help capture
degradation products of the substances with the same effects.
There are 9,000+ per- and polyfluoroalkyl substances (PFAS) in existence, which makes
regulating PFAS individually infeasible. It is estimated that an EU PFAS ban in firefighting
foams may cost society €390 million per year over a 30-year period (26). For surface water
the major pathway is fire-fighting foams providing significant losses directly to the
wastewater system. The environment of oil-drilling sites and airports (due to drills and
exercises) is typically highly contaminated, with potential remediation costs of €0.6-2.5
billion for the 85057
larger airports in Europe58
or even €18.3 billion when all EU military and
small airports59
are included. Economic benefits from avoiding PFAS ending up in water
include the potential for water reuse, including for irrigation purposes in line with the new
Regulation on minimum requirements for water reuse. Benefits (avoided costs) of PFAS
removal in waste water are considerable: at least €9.13 billion/year60
. Moreover, PFAS
removal processes create large additional amounts of waste (brine) – approximately 25% of
treated water (76) requires separate treatment and subsequent re-mineralisation to create
drinking water. Estimates of the avoided cost for reverse osmosis, specifically, to prepare
drinking water amount to over €1/m³ equalling circa €200 per household per year (77),
equalling avoid water treatment costs of 39.1 billion annually, if applied to all 195 million
EU households. Also, not having to use RO to produce drinking water will result in 20%
savings of water extraction volumes compared to a situation in which RO would be required.
Total annual health-related costs, for three different levels of exposure, were found to be at
least EUR 52 to EUR 84 billion in the EEA countries. Non-health-based costs environmental
PFAS remediation totalling EUR 821 million to EUR 170 billion (EEA/EU), with plausible
best estimate EUR 10–20 billion. In addition, measures at source would avoid costs of at least
56
Note PFAS substances include around 4,000 to 7,000 substances (depending on definition), so addition always requires grouping
approaches. Consequently, in this initiative PFAS are grouped using a grouping metric (PFOA-equivalents) and relative potency factors
(RPFs).
57
Eurostat : https://appsso.eurostat.ec.europa.eu/nui/setupDownloads.do
58
https://ourairports.com/continents/EU/
59
If counting all military and recreational airstrips the total number increases to 6106 airports: https://ourairports.com/continents/EU/
60
Results from the ZeroPM project (EU funded Horizon 2020) identified PFAS in 100% of the wastewater samples across the EU
https://zeropm.eu/ and https://www.ngi.no/eng/Projects/ZeroPM
EN EN
€39.4 million EU-wide related to a complete removal of PFAS from paper mills effluents and
sludges.
Health costs of hormone disrupting chemicals, including estrogenic hormones, are estimated
at €150 billion a year61
. Studies also show strong toxicological evidence for male infertility
attributable to EDC exposure, with a 40-69% probability of causing 618,000 additional
assisted reproductive technology procedures, costing €4.71 billion annually (78) (79) (80).
The effects of the exposure such endocrine disrupting substance (EDCs) have been linked to
reproductive problems (e.g. with declining sperm counts), some cancers, impaired
intelligence, obesity and diabetes, but also with effects on animals, with invertebrates being
the most sensitive (81). Studies concluded an EDC causation for IQ loss and associated
intellectual disability, attention-deficit hyperactivity disorder, childhood obesity, adult
obesity, adult diabetes, cryptorchidism, male infertility, and mortality associated with reduced
testosterone, e estimated to cost of €157 billion (corresponding to 1.23% of EU gross
domestic product) annually (82). For macrolide antibiotics, measures across the life cycle of
medication are required. As an example, many pharmaceuticals but also PFAS, can harm
reproduction, reproductive success, and population health not only for aquatic species, but
indirectly also for humans. Therefore, benefits are also expected for the aquaculture sector
through avoided costs associated with losses of fish and shellfish populations in aquaculture
farms. Some of the most affected species are trout (2019 EU production value €677 million),
seabass (€491 million), crustaceans (€1.05 billion) and salmon (€1.34 billion) (83). Assuming
that 5% -10% of the production value can be related to EDC exposure results in annual EU
wide avoided costs ranging from €177 - €355 million.
Social impacts of the policy option assessed in this paragraph are, as mentioned in Annex 9,
table A9.3, limited to more effective management of the substances when grouped as
opposed to individual listing.
6.2.3 6.2.3 Policy option 3 – revising EQS for certain existing PS
The assessment finds that, for the substances concerned, the additional effort to be made by
MS to reach the EQS will be small to relatively large (see Chapter 6.1.1 and Annex 4).
For cypermethrin, a combination of source control, substitution by less harmful alternatives,
and end-of-pipe measures are likely needed as the substance is commonly used as pesticide
and wood preserving chemical. Costs to remove cypermethrin in UWWTPs are estimated at
€26.2 (per population equivalent, per year). PBDEs and Di-2-ethylhexyl phthalate (DEHP)
and its compounds are associated with health effects such as cognitive deficits, (testicular)
cancer and cryptorchidism as well as adult obesity, adult diabetes, and reproductive effects
for females (endometriosis) (84). Mercury and its compounds and organophosphate
pesticides are associated with cognitive deficits resulting from exposure (85).
For diuron and chlorpyrifos, market authorisations expired recently, meaning remaining
stockpiles will be used up and exemptions (emergency authorisations) will drive emissions.
Other topics relate to legacy issues resulting from the persistence of such substances. For
61
https://www.bbc.com/news/health-31754366 and https://www.theguardian.com/environment/2015/mar/06/health-costs-hormone-
disrupting-chemicals-150bn-a-year-europe-says-study and https://www.endocrine.org/news-and-advocacy/news-room/2015/estimated-costs-
of-endocrine-disrupting-chemical-exposure-exceed-150-billion-annually-in-eu
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diuron a possible remediation measure could be removing and replacing obsolete
contaminated wood-based infrastructure. In some instances, the use of dredging may be
appropriate for the removal of substances bound to the sediment in waterbodies, which can be
relatively cheap or very costly, depending on the level of after treatment required.
The social impacts of this option are principally in greater human health protection from the
chronic or bio accumulative nature of the pollutants concerned. Details can be found in
Annex 9, table A9.4.
6.2.4 6.2.4 Policy option 4 – deselection of priority substances
These substances were identified to no longer pose an EU-wide risk to the environment and
public health. Alachlor, Simazine and Chlorfenvinphos (herbicides) have banned in the EU
for many years, and concentrations above the EQS are identified in a very limited number of
water bodies (table A11.2). Therefore, the overall risk to the environment is considered to be
low.
Use of Trichlorobenzenes (solvents and chemical intermediates) is ongoing, and the
substances are acutely toxic to the aquatic environment. The rates of EQS exceedance are not
very high, but deselection is more questionable than for the other substances given the degree
of risk they post and their relevant for the MSFD.
Carbon tetrachloride is not recognised as a POP and the rates of EQS exceedances are low
with declining trends, indicating localised issues and no EU-wide risk. Also, the ongoing use
of this substance is directly or indirectly controlled and monitored under other policies like
REACH, IED, the Regulation for the Classification and Labelling of Chemicals (CLP),
therefore deselection from the PS list would not result in a negative environmental or societal
impact.
All substances have in common that, even if they were removed from the PS list, they might
still be relevant as RBSPs, and MS could decide to continue monitoring them at national level
where needed. Deselection could free up resources that can be reallocated to emerging risks,
e.g. due to saved monitoring costs (between €4 and €12 million annually at EU level).
Deselection as assessed in option 4 is not expected to have negative social impacts since the
risk of exposure to the substances concerned is very low. A possible negative effect, in
relation to trichlorobenzenes and carbon tetrachloride, may be that less monitoring would
reduce the information base for deciding on reduction measures. Hence for these substances
an approach at River Basin level should be considered.
Box 15: Views on impacts of deselection expressed during consultation activities
Deselection of Alachlor, Chlorfenvinphos and Simazine was considered by most (respectively 47%, 46% and 45%) of the TEC
respondents to have no negative impacts for either the environment or human health, whereas only 8% thought so for Carbon
tetrachloride. The biggest concern raised for deselection was a loss of monitoring data to track trends. However, one respondent
highlighted that if there was a concern a substance could be retained as an RBSP.
Many (i.e. 48-64%) respondents ‘didn’t know/had no opinion’ regarding the economic benefits of deselection, however, the
remaining responses indicate deselection to have at least some economic benefits for all substances considered (28-45%).
Note: Trichlorobenzenes were not included in the consultation surveys due to their late addition to the candidate list for
deselection.
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6.3 6.3 Groundwater – impacts of policy options
A key aspect of understanding the potential impact of the groundwater policy options is
defining the “gap” between the baseline situation and meeting the proposed GW QS or likely
national TVs set at MS level for pollutants listed in Annex II of the GWD. Subsequently this
assessment was used as the basis for determining the types and potential level of uptake of
measures needed to get to good chemical status, and how their implementation would impact
stakeholders. Likely environmental, economic and social impacts were assessed, and various
impacts of the options described (incl. the administrative burden on responsible authorities).
It needs to be noted however that the quality of the data for groundwater in Europe are, for
several reasons62
, of a lower quality compared to surface water. Consequently, the outcomes
of the distance to target assessment and the comparison of the impacts of the policy options
are subject to a higher level of uncertainty.
Measures to address PFAS, nrMs or pharmaceuticals can be remediation of soil or the
groundwater (e.g. in case of polluted fire-fighting sites), source control (bans or restrictions
on use, substitutes, guidance on proper use, avoiding production losses) and end-of-pipe/
pathway disruption (wastewater or landfill leachate treatment, incineration or landfilling).
Costs vary strongly depending on the type of measure. Examples can be found in Annex 10.
6.3.1 6.3.1 Policy option 1 – listing LFR substances individually or as group of
specific chemicals in GWD Annex I
PFAS
The main additional expense for most MS will be the costs of laboratory analysis, and in
particular Option 1 (a group of 24 PFAS in Annex I and assigned a GW QS of 4.4 ng/l PFOA
equivalent), where a “sum of” methodology or very low concentrations need to be analysed
and are likely to require more effort, and 2 (all PFAS in Annex I with a GW QS for “PFAS
total” of 0.5 µg/l). The measures likely to be used by MS are similar for all options (aside
from Option 3).
A cheap source measure to reduce future emissions of one of the 24 specific PFAS would be
to use other PFAS substitutes not used yet. This would however potentially trigger new
legacy issues in the future because of PFAS persistence. For the regulated PFAS (PFOS,
PFOA, PFHxS, PFHxA and the C9-C14 carboxylic acids) stringent measures that restrict
emissions are already in place; it is likely that, for the remaining group of 10 substances,
which overlap with the DWD substances and the EQSD proposed substances, further controls
should be instigated at the EU level with cost to industry.
Pathway disruption measures like the capture of contaminated sludge, containing and
incineration are very costly due the energy intensiveness, so these measures are suitable only
in extreme circumstances. Guidance on the best practise use of waste and wastewater by-
products in agriculture would be a cheaper option. However, this will ultimately result in
62
For the 15,930 GWBs reported by the EU27 in 2016, a large number of water bodies have no monitoring results. This means their status is
assessed through grouping of characteristics including pressures and risk, extrapolation of evidence, and expert judgement. Generally, the
GW WL data is of much lower quality compared to surface water watch list data for reasons like the voluntary nature of data collection and
inconsistent reporting formats used.
EN EN
PFAS accumulating in agricultural soils. Instead of using pathway disruption measures, it is
more likely that for Options 1 and 2 actions to restrict use of PFAS and better management of
waste streams are used, as well as groundwater or soil remediation.
Pharmaceuticals
As regards Option 1 (adding Carbamazepine and Sulfamethoxazole to Annex I), this would
likely lead to some administrative burden on those MS which do not yet monitor these
substances. A worst-case estimate is €2 million per year at EU level.
nrMs
The costs of adding nrMs to the monitoring networks are likely to be limited, since the
existing framework for assessing risk to groundwater from ‘parent’ pesticides and their
relevant metabolites are already in place. A small increase in costs is likely for Option 1
(adding all nrMs to Annex I as individual substances with a GW QS of 0.1 µg/l), since it
requires, at least for those countries which are not already doing this, that “all nrMs” are
included in the analysis.
The implementation of the EU Farm to Fork Strategy will likely lead to reductions in the use
of any permitted parent pesticides of the nrMs considered. This will be delivered in part
through the planned revision of the Directive on the Sustainable Use of Pesticides and
national action plans for pesticide use reduction. This will limit what additional measures
need to be taken to protect their water bodies. By including all nrMs in Annex I under
Options 1 and 2, the administrative burden may be progressively reduced further as the
legislation would be “future proofed”.
Environmental benefits are rather similar for all the nrM options but options covering all
nrMs and setting a GW QS at EU level (i.e. Option 1 and 2) are expected to generate greater
benefits. Benefits include reduction and possibly reversal of impacts on groundwater biota,
benefits for ecosystems services provided by the groundwater and linked surface water,
increased quality process water from groundwater / surface water for drinking water,
agriculture and industry.
6.3.2 6.3.2 Policy option 2 – listing LFR substances as groups of substances in GWD
Annex I
By grouping similar pollutants, with a GW QS for the total group, legislation can deal with
large substance groups with rapidly changing information on the impacts which would, in a
sense, “future proof” legislation.
PFAS
The main additional expense under Option 2 (all PFAS in Annex I with a GW QS for “PFAS
total” of 0.5 µg/l) for most MS will be the costs of laboratory analysis.
Pharmaceuticals
The main administrative benefit of Option 2 (adding all pharmaceuticals as a group to Annex
I) is that it “future proofs” the listing by including substances which may become problematic
in future and stimulates the modernisation of analytical techniques. The latter would result in
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considerable cost savings as soon as modern techniques have become more commonplace.
Under Option 2b direct analytical costs will be around €5.5 million per year, with potential
administrative costs taking this up to a total of €11 million per year. For Option 2c (adding all
pharmaceuticals as a group to Annex II for MS to consider setting a TV), the analytical costs
will vary between MS depending on the TVs adopted and the monitoring strategy used, but
the impact on administrative burden to MS would be smaller.
Estimated costs of measures for Option 2 are shown in Annex 10. Many of these are
considered cost-effective and acceptable for society. The main environmental costs of adding
pharmaceuticals to the GWD would be implementation of measures to deal with wastewater
/biosolids containing pharmaceuticals which can be energy intensive and require the use of
chemicals. The incineration /landfilling of biosolids is suggested as a last resort measure as
there is currently no viable treatment to remove pharmaceuticals from these media.
Environmental benefits of adding substances largely consist of lower risk of (irreversible)
damage to natural ecosystems. These benefits are greatest under Option 2, due to the wider
range of pharmaceuticals addressed.
Under Option 2 the understanding of the impact of pharmaceuticals on groundwaters is most
pronounced. Also, the aim of the Pharmaceuticals Strategy to reduce the level of anti-
microbial resistance is best supported by this option.
nrMs
The costs of adding nrMs to the monitoring networks are likely to be limited, since the
existing framework for assessing risk to groundwater from ‘parent’ pesticides and their
relevant metabolites are already in place. A small increase in costs is likely for Option 2
(adding all nrMs to Annex I with a group GW QS of 10 µg/l), since it requires, at least for
those countries which are not already doing this, that “all nrMs” are included in the analysis.
Environmental benefits are rather similar for all the nrM options but options covering all
nrMs and setting a GW QS at EU level (i.e. Option 1 and 2) are expected to generate greater
benefits. Benefits include reduction and possibly reversal of impacts on groundwater biota,
benefits for ecosystems services provided by the groundwater and linked surface water,
increased quality process water from groundwater / surface water for drinking water,
agriculture and industry.
6.3.3 6.3.3 Policy option 3 – listing LFR substances in GWD Annex II
PFAS
Option 3 for PFAS would lead to TVs being set by individual MS using drinking water
standards and likely focusing on point source pollution rather than on diffuse pollution. The
most likely measures to deal with pollution point sources could be to initiate soil remediation
measures, e.g. for pollution hotspots like firefighting sites. This option would moreover lead
to diverging national TVs and thus be detrimental to the objective under Art. 7 WFD to
setting uniform EU quality standards for groundwater. Setting a uniform GW TV at EU level
would, on the contrary, lead to savings in treatment costs.
EN EN
Costs for all PFAS inclusion in Annex II for MS to consider setting a TV (Option 3) will be
the lowest, given the DWD requirements and additional data collated. This is especially the
case for the MS which are already monitoring PFAS and carrying out risk assessments for
groundwater.
Pharmaceuticals
Option 3 will have significantly less environmental benefits compared to Options 1 and 2 and
distortion of the ‘level playing field’.
nrMs
The costs of adding nrMs to the monitoring networks are likely to be limited, since the
existing framework for assessing risk to groundwater from ‘parent’ pesticides and their
relevant metabolites are already in place. The administrative burden of Option 3 (adding all
nrMs to Annex II for MS to consider setting a TV) will be smaller at EU level but higher at
MS level, because of the need to set TVs at national level.
Additional measures that could be considered by MS would mainly focus on the amenity
/legacy pollution including substitution through less harmful substances, remediation of
existing / historical sources and use of other weed control methods for amenity use.
If measures taken by MS to reduce nrMs in groundwater would include source control such
as restrictions on use this would have an impact on the farming sector and possibly also on
crop yields. Estimated costs of using substitution products are shown in Annex 10: it should
be in particular stressed that less toxic alternatives do exists for at least the five permitted
parent pesticides, with similar cost ranges.
For Option 3 (TV set at MS level) greater variance in environmental benefits is expected
between MS. Benefits include reduction and possibly reversal of impacts on groundwater
biota, benefits for ecosystems services provided by the groundwater and linked surface water,
increased quality process water from groundwater / surface water for drinking water,
agriculture and industry.
As specified in tables A9.7 through A9.9 social impacts are mostly related to better protection
of health due to lower exposure to substances, in particular from the PFAS group and
pesticides. Indirect social benefits are generated through improved ecosystem services (better
protected water sources, recreation, less polluted fish etc). Possible negative effects include
lower yields increased costs in farming or higher costs, as well, in relation to antibiotics, a
limited reduction of choice in available antibiotics options.
Impacts on SMEs under the groundwater options follow the same pattern as under the surface
water options.
EN EN
Box 16: Views on positive impacts of listing groundwater pollutants expressed during consultation activities
Majority of TEC respondents were unsure about the significance of benefits of listing new groundwater pollutants (32-56%
indicating ‘I don’t know / No opinion’). Overall, cumulative positive impacts were perceived for all categories included in the
questionnaire, with the following significance levels most widely chosen:
 Major benefits from improved water quality, improved environment and human health protection (35%), lower
production and maintenance costs through availability of cleaner raw water (32%), improved well-being (2%).
 Moderate benefits associated with availability of clean GW for abstraction (24%).
 Minor benefits from increased resource efficiency through reuse and recovery of materials (32%), climate change through
reduced energy use (29%), lower risk of (irreversible) damage to natural resources (21%).
Views on the significance of benefits from increased potential employment opportunities were inconclusive (major and minor
levels each selected by 18%). Respondents were most sceptical about benefits from reduced risk of water-related illnesses and
premature deaths (21% selecting ‘No benefit’), benefits for agriculture and industry as well as wastewater treatment (15%).
6.4 6.4 Monitoring, reporting and administrative streamlining – impacts of
options
The impacts of all policy options related to monitoring, reporting and administrative
streamlining are described below. Clear synergies exist between this initiative, the Zero
Pollution Outlook, and the Commission proposal for a Regulation of the Industrial Emissions
Portal (IEPR, former E-PRTR), the EU Strategy for Data, the INSPIRE Directive, and the
Directive on Public Access to Environmental Information. In particular, data collected under
policy options 3, 4, 6 and 7 would lead to better water quality data in shorter than the current
6-years intervals. This water related data could complement and be cross referenced with
publicly available data on emissions from industrial installations covered by the IEPR and
help monitor the effects of the implementation of new Best Available Techniques on the
aquatic environment surrounding such installations. Vice versa, an improved digital data
collection on geographical and seasonal pesticides use under the envisaged revised
Sustainable Use of Pesticides Regulation, would be highly valuable input for an improved
implementation of legislation like the WFD and the EQSDs, as well as the EU Biodiversity
Strategy 2020, the common agricultural policy (CAP), and the Thematic Strategy on Soils.
Finally, for practically all of (sub)options, related to digitalisation, improved monitoring etc.,
existing EU research projects funded through FP7, H2020 and Horizon Europe can support a
further practical development, and outcomes of past and ongoing Research & Innovation
(R&I) projects could consequently also help reduce costs of an increased digitalisation .
Box 17: Views on monitoring, reporting, and administrative streamlining options expressed during consultation activities
Regarding monitoring approaches, varying views were provided on guidelines to alternative monitoring methods, noting that
innovative approaches (such as EBM) could improve freshwater quality yet may result in a greater monitoring burden to actors.
Respondents voted the increase in monitoring frequency of substances in the Surface Water Watch List as the most effective
method for improving the risk response and management (average score of 3.2 on a scale from 1 - not at all – to 5 – very much).
However, the responses received displayed significant polarity: 26% (n=12, represented by a mix of business associations,
companies and MS competent authorities) rating the measure as non-effective (i.e. 1) and another 28% (n=13, mostly
representatives of MS authorities and academic research) as highly effective (i.e. 5).
On data management, most benefits were perceived for guidelines to standardise data collection and reporting formats. Overall,
the responses indicated that a combination of approaches may be more suitable in achieving the desired harmonization of the RBSP
thresholds rather than just one specific measure.
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6.4.1 6.4.1 Policy option 1 – Guidance and advice on monitoring
Sub-option (a): Develop guidelines on applying innovative methods in monitoring
procedures, including continuous / automated monitoring techniques
The impacts of Sub-option 1a are limited since it would summarise best practise examples
and use those to detail how approaches can be implemented. The expected costs are limited,
but the potential impacts and associated benefits for MS monitoring programmes can be
significant if properly implemented and would lead towards harmonised monitoring and
measurement approaches for contaminants of emerging concern. The costs for developing EU
guidelines ranges from around €290,000 for simple guidance documents to around €500,000
for more elaborate documents (see Annex 10). Based on the assumption that around 1 or 2
guidance documents on innovative monitoring methods would be required, total EU costs
range from €580,000 to €1 million.
Sub-option (b): Improve existing EBM guidelines to improve monitoring of
groups/mixtures of pollutants by using EBMs, and define trigger values for assessing
the status of a water body.
The impacts of Sub-option 1b involve the further development of guidelines on the types of
effect-based methods, and deriving trigger values63
for mixture pollutants to be applied in
practise. Effect-based trigger (EBT) values establish the likelihood of adverse impacts on
water quality and are used to differentiate good from poor water quality. EBT values for in
vitro bioassays can be used to assess if a water body is in good or poor status based on the
effects on the aquatic organisms. Also, by dividing bioanalytical responses by their respective
EBT values, effect-based risk quotients can be obtained, which can then be summed per
location to assess the cumulative ecotoxicological risks. Consequently, they are important for
surface water quality monitoring while considering mixture toxicity, but of course in close
alignment with EQSs for individual chemicals. Costs for the further development of EBM
guidelines are comparable to those of a simple guidance document and are estimated at
€290,000.
Sub-option (c): Develop a harmonised measurement and monitoring method and
guidance for microplastics in surface water and groundwater, as a basis for MS
reporting on microplastics and a future listing under EQSD and GWD.
Overall cost to society of microplastics is estimated between €10.8 to €19.1 billion (36) (86).
One major microplastics category the EU intends to address (others are textiles, pellets,
paints, geotextiles, detergents capsules) is tyres. A recent revision of the Tyre Approval
Regulation has removed the worst performing tyres from the market (87) while EU labelling
of tyres according to their abrasion rates is a strong incentive to push the market to the best
performing tyres amongst those left on the market. Physical barriers to avoid microplastics
ending up in surface waters would be effective measures as well (so called gully pots to
capture particles or microplastic filters in washing machines (88) as foreseen in the EU
microplastics initiative. End-of-pipe treatments for microplastics could be effective too, at a
cost between €0.08-0.20 per cubic metre of wastewater treated per year (see upcoming
63
Bioassay responses are compared to effect-based trigger values to identify potential ecotoxicological risks in water bodies (126).
EN EN
UWWTD revision, whereby the application of tertiary level treatment in WWT plants is
being proposed for larger agglomerations at risk). This treatment will trigger knock-on
problems with the plastic-contaminated sludge, which are being assessed in the ongoing
Evaluation of the SSD
The impacts of Sub-option 1c involve the costs of development of a harmonised
measurement standard and guidelines for monitoring. As a relatively unchartered territory,
initial costs may be higher than for traditional chemical substances or groups of substances.
Based on expert judgement from the JRC related to developing a harmonised measurement
and monitoring method for microplastics in drinking water, and information from EU funded
projects supporting the EU Plastic Strategy64
, the development of a harmonised measurement
and monitoring methodology for microplastics and the accompanying guidance is estimated
to cost between €290,000 to €500,00065
. Once the method is developed, the annual EU costs
for measuring and monitoring microplastics are estimated to range from €7.3 to €13.4
million66
.
A harmonised measurement and monitoring method for microplastics is a vital prerequisite
for monitoring by MS and future development of policies to reduce emissions to surface
water, groundwater and coastal waters. Mandatory monitoring according to a harmonised
methodology will provide a wealth of monitoring data on types and quantities of
microplastics occurring in surface water, groundwater and coast waters. Firstly, this is
paramount for improving the current limited understanding of the environmental fate and
behaviour of microplastics. Secondly, this supports follow-up studies like the Bleu2 study
(89), and allows developing and validating future simulation models (no microplastics
simulation model was found in the EC Modelling Inventory (MIDAS)). Finally, obtained
monitoring results could facilitate the assessment of effectiveness of other EU policies
dealing with microplastics (e.g. the upcoming initiatives on controlling unintentional
releases).
Sub-option (d): Develop guidelines on sampling frequency for PSs and RBSPs.
Sub-option 1d involves the development of a guidance document for MS on best-practice
sampling approaches for PSs and how to integrate such approaches into water-quality
assessments and monitoring strategies. This sub-option will require limited administrative
effort, particularly at EU level, while benefits relate to increased harmonisation of sampling
frequencies across the EU, and therefore greater comparability of data between countries and
river basins, allowing for more targeted policy interventions. Costs to develop these
guidelines are expected to be between €290,000 to around €500,000 (Annex 10). The Fitness
Check of EU environmental reporting and monitoring acquis (10) estimated the approximate
annual administrative burden related to reporting to MS for the EQSD to be moderate (i.e.
within the range of €30,000 and €100,000 per MS). The estimated additional costs of aligning
sampling frequencies to the developed guidance is expected not to exceed more than 5-10%
of those costs.
64
Horizon 2020 EUROqCHARM project works towards validated harmonised methods for monitoring & assessing macro-, micro- and
nanoplastics in environment: https://www.euroqcharm.eu/en
65
Estimate based on development of microplastics methodology for Drinking Water Directive and the qualification of guidance documents
from Annex 10 Table A10.5.
66
Based on the assumption that each MS will designate one of its water analysis laboratories as national laboratory of excellence for
measuring microplastics. Between 5% and 10% of the total number of surface water bodies and groundwater bodies would be sampled.
Estimates of CAPEX and OPEX costs were taken from literature.
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Sub-option (e): Provide a repository for sharing best practices from MS regarding
available monitoring techniques, and foster cooperation to implement these.
Option 4 foresees the development of an online repository of standards and best-practice
approaches to improving MS monitoring techniques. This would build upon and complement
option 1, providing a living, online location to allow consistent updates on monitoring
techniques and providing a forum for actors to facilitate knowledge transfer. This option will
require a limited administrative effort, particularly at EU level. Cost of developing and
hosting a simple repository of best practices is similar to those for drafting guidance
documents and ranges from €290,000 to €500,000 (Annex 10, Table A10.5).
6.4.2 6.4.2 Policy option 2 – Obligatory monitoring practices
Sub-option (a): Include an obligation in the EQSD to use EBMs to monitor estrogens.
Option 2a involves the mandatory use of EBMs to monitor estrogens in practice (90).
Commercially available bioassays (e.g. ER-CALUX, A-YES and others) are important tools
for assessing the toxicity of water samples (91). License-free versions of this type of assay
are commercially available and are covered by international inter-laboratory trials. ISO
19040-3 defines validity criteria covering further cell-line-based reporter gene assays. Also,
sample preparations do not require special treatment, and extraction / concentration methods
are based Solid Phase Extraction (also used for analytical methods) which is very cheap. If
performed in-house, costs of around €60/sample (incl. costs for personnel and consumables)
are possible. If using commercial labs, costs are around €60-200 euros per sample. Standard
Operating Procedures (SOPs) for this type of in vitro EBMs are available and three assays are
even ISO standardised. Standardisation has already driven down costs, but future further
validation and inter-laboratory studies for other bioassays, used to evaluate effects from
estrogenic compounds, would provide a wider choice of methods and result in a further
decrease of costs in the coming years. EBM related costs can also be reduced by reusing
outcomes of FP7 funded research projects like ‘Solutions’. Solutions already developed
chemical, effect‐based and ecological tools for monitoring and assessing the presence and
effects of mixtures including contaminants of emerging concern (92).
Sub-option (b): Establish an obligatory Groundwater Watch List mechanism analogous
to that for surface waters and drinking water, and provide guidance as necessary on the
monitoring of the listed substances.
Impacts of this sub-option are comparable to those of the existing SW WL and consist of
annual sampling and analysing, by MS, of a limited number of substances. The information
gathered would be collected and analysed at EU level, at an approximate annual cost below
€1 million. The administrative cost at MS level are comparable to those of the EQSD (see
option 1 sub-option d), i.e. between €30,000 and €100,000 per MS per year. The benefit,
compared to the existing voluntary watch list, is in achieving a much-improved data set,
allowing more targeted and effective policy interventions at both EU and national level.
Sub-option (c): Improve the monitoring and review cycle of the Surface Water Watch
List so that there is more time to process the data before revising the list.
The sub-option would require, for some substances, an increased frequency of
sampling/analysis for monitoring, which would however be compensated by an extension of
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the watch list review cycle from 2 to 3 years. Therefore, it is expected that the cost impact
will be neutral. The major benefit is in capturing substances that have strong seasonal
fluctuations, rendering the watch list results more accurate.
6.4.3 6.4.3 Policy option 3 – Reporting and classification
Sub-option (a): Establish an automated data delivery mechanism for the EQSD and the
WFD.
Currently, the minimum frequency of monitoring of priority substances in surface water is
once per month. However, the aggregated data are only reported every six years. The benefits
of sub-option 3a are in obtaining more frequent accessibility of monitoring and status data,
allowing to show to the public and policy makers at EU and MS level intermediate progress.
It is expected that this will require a significant administrative effort both at EU and MS
level. On the EEA side, the costs of facilitating an increased "digitalisation" to accommodate
this option will require additional staff at EEA plus EUR 50-100K / year for IT consultancy
and hardware. Preparedness for an automated data delivery mechanism varies across MS
authorities. While MS maintain their own data sources, data is not usually aligned in terms of
spatial coverage and temporal trends and thus requires harmonisation. Also, the system of
‘pass /fail’ does not provide much insight in the magnitude of exceedances and thus hampers
focusing policy responses on pollution hotspots. If concentration data would be reported, this
would yield valuable information to investigate the nexus between better water quality and
improved human health by using data from the water quality monitoring and evaluation.
Expected efforts needed to streamline reporting will, in the long-term, be compensated by
reduced administrative burdens, with costs also likely to reduce in the medium to long term.
In addition, through digitalisation and automated data reporting, MS data and metadata can
be more easily and more frequently accessed and compared, and made available via an
online, centralised platform, making them more transparent and up to date. This intervention
is coherent with the Zero Pollution Monitoring and Outlook as it improves the basis for better
Water Pollution Outlooks reports and introduces co-benefits for the ‘1-substance-1-
assessment’ work by ECHA.
The harmonised digital automated data delivery will simplify reporting on inventory of
emissions and increase links with the revised Industrial Emissions Portal. This is beneficial
for the obligation for MS, according to Article 5 of the EQSD, to establish an inventory of
emissions, discharges and losses of all PS and pollutants listed in Part A of Annex I the
Directive. This is also coherent with the recent Commission proposal establishing an
Industrial Emissions Portal (93), as it can improve the exchange of data between the EU
European Pollutant Release and Transfer Register (E-PRTR) and the inventories of industrial
emissions. This will enhance the implementation and policy making (including at EU level)
through more transparent and real time data enabling focussed decision making and effective
control. This would also be beneficial for an increased compliance by MS with the provisions
of the EU INSPIRE, and Access to Environmental Information Directives. It also increases
coherence with the proposed EU Data Act (94). Whilst there may be an initial administrative
burden resulting from the instalment of interoperable data sets which can be accessed by the
EC and the relevant EU Agencies, considerable gains, including a reduced administrative
burden for MS, are expected in the medium and long run.
EN EN
Sub-option (b): Introduce a reference list (repository of standards) of environmental
quality standards (EQS) for RBSPs as an annex to the EQSD, and incorporate RBSPs
into the assessment of chemical status for surface waters.
Creating a repository assists MS in deriving national EQS, in turn allowing EU standards to
be developed and included in the repository following adoption by comitology. This aligns to
a proposal under the Chemicals Strategy, which envisages the development of a wider
repository of all EU standards for chemical substances. EQS data could feed directly into that
work. A harmonised repository would lower the overall administrative burden.
A common repository of standards would secure that knowledge stays accessible to MS and
stakeholders. According to EEA data, MS have reported around 150 RBSPs under the 2nd
RBMPs. This data would be transferred to the EEA / JRC in a one-off migration to the newly
created EU repository. This facilitates quality assurance and measures for RBSPs at River
Basin Districts (RBDs) level. One-off costs for developing a repository of standards are
comparable to those for developing guidance (€290,000 to €500,000). For hosting and
maintenance 0.5 FTE plus EUR 10-20K / year for IT consultancy/hardware are required.
The second part of this option aims at ensuring that, when assessing the chemical status, the
results of the RBSPs assessment are included in the assessment of the overall chemical status
of a SWB (currently the results are assessed as part of the ecological status assessment). This
will improve the consistency within the WFD. This is a relatively significant change for MS
and stakeholders and would result in a one-off alignment of reporting systems. Benefits
would consist of removing the bias in the status of a SWB since it would be based on
harmonised EQSD for RBSPs as currently some MS might have implemented too strict or too
lax standards for their RBSPs. Another expected side-effect is that the number of WBs in
good ecological status would increase, since possible exceedances due to RSBPs have less
effects on achieving good chemical status as they are generally in worse status.
6.4.4 6.4.4 Policy option 4 – Legislative and administrative aspects
Sub-option (a): Use an annex in the EQSD instead of Annex X to the WFD to define the
list of PS, and update the lists of SW and GW substances by Comitology or delegated
acts.
This option would allow for a significant acceleration of the time required to update the lists
of substances under the EQSD and the GWD. The main impact in administrative terms is on
EU Institutions, which would be called to act via delegated acts rather than through the
ordinary legislative procedure. In environmental and public health terms, it will allow a
swifter policy reaction to emerging pollutants, and a faster delisting if pollutants are no
longer a threat, in line with the latest scientific progress and knowledge. Administrative costs
will be lower at EU level while at Member State level no significant impact is expected.
Sub-option (b): Change the status of the ‘eight other pollutants’ added to the EQSD
from the former Dangerous Substances Directive (76/464/EEC) to that of PS/PHS.
The eight pollutants concerned (pesticides Aldrin, Dieldrin, Endrin, Isodrin, DDT, and
industrial chemicals Tetrachloroethylene, Trichloroethylene, Carbon tetrachloride) are listed
in Annex I of the EQSD and have EQSs derived, but it is stated in footnote 7 of the Annex
that these substances are not Priority Substances. This creates confusion with WFD Article
EN EN
16.7. Their existing EQS monitoring feeds into surface water chemical status assessment. The
results of the assessment show that seven out of eight substances either a) are covered by
Regulation (EU) 2019/1021 on persistent organic pollutants (the POPs Regulation) obliging
MS to put into place and maintain inventories for such substances; b) show EQS value
exceedances in freshwater (no declining emission trends); or c) are covered by the DWD.
Therefore, these substances should be recognised as PS to avoid incoherencies with other EU
legislation. Specifically, this concerns the cyclodiene pesticides (Aldrin, Dieldrin, Endrin and
Isodrin), DDT, Tetrachloroethylene and Trichloroethylene. Marking them as PS will create
greater policy coherence, help track their presence in water and inform subsequent risk
assessments. Formally assigning them PS status is merely administrative and entails no costs.
Furthermore, it is not clear why some of these substances have not been designated as PHS67
under Annex II of the EQSD. Aldrin, Dieldrin, Endrin, Isodrin, DDT are POPs and
Trichloroethylene is SVHC, hence fulfilling the criteria for PHS status. The result of that is
that most of them (all except of carbon tetrachloride) are Persistent Organic Pollutants
(POPs) or should be marked as priority hazardous substances for other legislative or
toxicological reasons.
Consequently, with the exception of carbon tetrachloride which is proposed for deselection
(see SW option 4), all substances should be formally recognised as PS under EQSD Annex I
and some also as PHS under Annex II. Assigning PS/PHS status is merely an administrative
change without further negative impacts, but formalisation is preferred to continue their
monitoring.
Sub-option (c): Change the status of some existing PS to that of PHS where it fulfils the
criteria of the POP Regulation and/or Article 57 of REACH Regulation.
Since the last EQSD revision in 2013, five existing priority substances have been identified
as PHS:
 1,2-Dichloroethane is classed as SVHC under Article 57 of REACH Regulation.
 Fluoranthene PBT vPvB and is classed as SVHC under Article 57 of REACH
Regulation
 Lead is classed as SVHC under Article 57 of REACH Regulation
 Octylphenol ethoxylates (OPEs) are toxic to aquatic organisms even at low
concentrations and show edocrine disrupting properties. They break down easily to
octylphenols which are more harmful, not readily biodegradable and meet the criteria
for persistence or high persistence in the environment. Consequently, OPEs are
considered as SVHC requiring authorisation for specific use in the EU according to
Annex XIV of the REACH Regulation.
 Pentachlorophenol (PCP) is covered by the POPs Regulation.
67
PHS are a subset of PS that are identified as “toxic, persistent and liable to bio-accumulate, and other substances or groups of substances
which give rise to an equivalent level of concern” (WFD article 2(29)). Substances identified by the following processes and legislations are
relevant: Substances of Very High Concern (SVHC) under REACH, Persistent Organic Pollutants (POPs) under the Stockholm Convention
and substances identified as Persistent, Bio-accumulative and Toxic (PBTs) under Regulation (EEC) No.793/93.
EN EN
6.5 6.5 Administrative burden
As indicated in Chapter 6.4 the approximate annual administrative burden related to reporting
ranges from €30,000 to €100,000 per MS. The impact assessment estimated the additional
monitoring costs as €15-36 million per year for the whole EU. Costs of €2-4 million per year
for the EU were estimated for a database and the costs to develop technical specifications for
monitoring were estimated at <€0.2 million per year for the whole EU (10). However, the
Fitness Check on the EU environmental reporting and monitoring acquis also concluded that
the benefits of reporting obligations significantly exceed the costs, as without reporting
obligations the Commission cannot verify a correct implementation. This is even more
pertinent in light of the revamped impulse provided by the European Green Deal and the co-
legislators’ agreement to put in place an encompassing Environmental Monitoring
Framework under the 8th
Environmental Action Programme (95). In particular, the outputs
from this policy intervention would feed into the Zero Pollution Monitoring and Outlook
Framework announced by the ZPAP.
The costs related to putting in place an obligatory monitoring method for microplastics are
calculated to range from €7,298,800 to €13,362,700.
The administrative burden associated to the groundwater options is limited. For nrMs and
pharmaceuticals, these range between €2 and 11 million depending on the level of ambition,
with no significant additional administrative costs for risk /status assessments of substances.
For PFAS the EU costs are higher, and estimated between €15 and 48 million, depending on
the level of ambition, with no significant additional administrative costs for risk /status
assessments of substances. All options benefit from the focus on PFAS in the recast DWD,
triggering more attention for monitoring relevant substances in source water.
In the implementation of the WFD, EQSD and GWD, the Commission intends to concentrate
all work related to the identification and prioritisation of pollutants, including their risk
assessment, for inclusion in future revisions of the legislation and in the watchlists for surface
water and groundwater, at ECHA. This will require reinforcement of the staff table of ECHA,
though it should be noted that at the same time there will be some reductions in
administrative expenses in the Commission.
6.6 6.6 Note on impacts for individual MS
The differences in impacts across MS will vary depending on national measures already in
place and/or newly proposed and the extent of pressure-exerting activities (agriculture,
industry). For pharmaceuticals, for example, many MS already have compulsory or voluntary
return programmes in place (Belgium, Czech Republic, Denmark, France Greece, Italy,
Netherlands, Spain, Sweden), and/or launched environmental classification schemes for
pharmaceuticals (Finland) and/or started other Green Pharmacy initiatives (Finland,
Netherlands, Portugal, Sweden) and/or participate in EU funded projects in this area (the EU
#Medsdisposal campaign68
and the EU project "Priorisation and Risk Evaluation of
Medicines in the Environment"69
). The best practice paper on Green and Sustainable
68
EU Medsdisposal: is a pan-European interdisciplinary stakeholder collaboration campaign to raise awareness on the appropriate disposal
of expired or unused medicines in Europe and includes associations representing European healthcare, industry and student organisations:
http://medsdisposal.eu/
69
https://cordis.europa.eu/project/id/875508
EN EN
Pharmacy in Europe70
lists these as examples. In the abovementioned MS the potential
impacts of proposed quality standards for pharmaceuticals will likely be less, than in MS who
have not taken these (or other equivalent) measures.
The impacts also vary depending on the distance to target. As explained in section 6.1.1, it
was not possible to conduct this assessment for each Member State, hence the distance to
target indicates the situation at EU level. However, it can be considered that in MS and river
basin districts where the water already (mostly) meets the proposed standards, the impacts
will be less than in MS and river basin districts where the distance to target is still (relatively)
large. Generally, areas of intensive agriculture and pesticide use (DE, FR, ES and IT account
for 2/3 of sales of pesticides in the EU), those where domestic wastewater is not centrally
collected and therefore less connected to treatment networks (e.g. areas with low population
densities), as well as areas where the legislation on UWWT is not complied with (e.g. BG
and RO and parts of IT, ES, PT), and water bodies with a limited flow (i.e. less dissolution of
pollutants) would see the highest impact.
In summary, the EU water legislation does not specify exact measures to be taken to reach a
given water quality standard, meaning that the respective efforts required by MS are largely
dependent on the current status of pollution and individual choices (beyond what is required
under EU legislation) of MS to address the situation with country specific measures.
7 7 HOW DO THE OPTIONS COMPARE AND WHAT ARE THE PREFERRED OPTIONS?
The comparison, where relevant, and evaluation of proposed surface and groundwater policy
options is structured around the pollutants being assessed, i.e. the following:
 Pollutants considered for addition to the Priority Substance list (surface water options
1 and 2);
 Pollutants considered for existing EQS amendment (surface water option 3);
 Pollutants considered for deselection from the Priority Substance list (surface water
option 4);
 Pollutants considered for addition to the GWD Annexes I and II (groundwater options
1, 2 and 3);
The evaluation of proposed monitoring, reporting and administrative streamlining options is
structured around the policy elements being assessed, i.e. the following:
 Policy elements addressing monitoring guidelines;
 Policy elements addressing obligatory monitoring practices;
 Policy elements addressing reporting and classification;
 Policy elements addressing legislative and administrative aspects.
The assessment is presented below, with tables summarising the overall magnitude of
impacts (considering the economic, environmental, and societal costs and benefits set out in
Chapter 6, Annexes 3 and 9).
In addition, the efficiency, effectiveness and coherence of each of the policy options has been
assessed and the results are summarised in throughout the tables in this section.
70
https://www.pgeu.eu/wp-content/uploads/2019/11/PGEU-Best-Practice-Paper-on-Green-and-Sustainable-Pharmacy-in-Europe.pdf
EN EN
Quantitative and qualitative factors were considered in assigning the rankings for each
criterion. The scale outlined below shows how "+" and "-" are attributed to positive and
negative impact expectations.
Very
large
negative
impact
Large
negative
impact
Medium
negative
impact
Small
negative
impact
Balanced
impact
Small
positive
impact
Medium
positive
impact
Large
positive
impact
Very
large
positive
impact
---- --- -- - +/- + ++ +++ ++++
The multi-criteria evaluation made of impacts, effectiveness, efficiency and coherence of the
policy options provides support for the preferred policy package.
7.1 7.1 Surface water
The substances in the surface water options were grouped into three different categories. A
first category in which the benefits of adding candidate substances to the PS list clearly
outweigh the costs (with a sub-category for micro and nanoplastics). A second category
where the costs and benefits are more balanced (in these cases a clear set of benefits have
been identified, meaning that adding them is worthwhile, but there is a closer balance
between the costs and benefits). For the third category, the costs outweigh the benefits.
7.1.1 7.1.1 Pollutants considered for addition to the PS list
The individual (SW option 1) and group (SW option 2) additions of candidate priority
substances were compared, where possible, and the preferred option selected for relevant
substances. More detailed information about the comparison of environmental, economic and
social impacts of these options can be found in Annex 9.
Benefits clearly outweigh the costs for: industrial chemicals - PFAS (all 24 named substances
plus the total of all PFAS) (96); pesticides (Glyphosate, Triclosan); neonicotinoid pesticides
(Acetamiprid, Imidacloprid, Thiacloprid, Thiamethoxam); pyrethroid pesticides
(Deltamethrin, Permethrin, Bifenthrin, Esfenvalerate); pharmaceuticals (Carbamazepine,
Diclofenac); macrolide antibiotics (Azithromycin, Clarithromycin; Erythromycin); estrogenic
hormones (17-Alpha-Ethinyl estradiol (EE2), 17-Beta estradiol (E2), Estrone (E1)).
As detailed in Annex 9, benefits largely relate to avoided healthcare costs stemming from an
expected reduced exposure to harmful substances – to be noted this is exposure through all
environmental media, not only groundwater or surface water. Specifically, for PFAS, the
avoided health costs thanks to reduced exposure (via consumer products, background levels)
a result of all EU and Member States policies addressing PFAS – therefore not only those
linked to this initiative – are estimated at €52-84 billion/year. According to the Centre for
Disease Control and Prevention (CDC), antimicrobial resistance adds a 20-billion-dollar
surplus in direct healthcare costs in the United States, which is exclusive of about 35 billion
dollars in loss of productivity annually. Numbers for the EU are comparable. The threat of
antimicrobial resistance is of particular importance in the category of antibiotic resistance in
EN EN
bacteria. The European Union has an annual mortality rate of 27,000 attributable to AMR.
This is comparable to the United States where 2 million people are affected every year by
AMR and about 23,000 die as a result71
. Worldwide, 700.000 people die annually from
resistant infections and this means that if no action is taken, the estimated annual deaths
attributable to AMR will be 10 million by 2050 (a 14-fold increase). Water can be a reservoir
of bacteria resistant to pharmaceuticals due to the presence of pharmaceuticals as pressure,
and/or bacteria that are co-resistant to both antibiotics and silver (bacteria share the same
mechanism of the resistance). OECD analyses from 2018 found that investing just EUR 1.5
per capita per year in a policy package to tackle AMR is effective and cost-saving, avoiding
27 000 deaths and saving around EUR 1.5 billion each year in EU/EEA countries72
. Without
action AMR related costs will likely also increase 14-fold by 2050 which could then result in
annual AMR related costs of around 21 billion by 2050. The EU benefits from an enhanced
protection against the development of AMR is estimated at around €1.5 billion/year based on
healthcare costs and productivity losses (relevant e.g. for the substances Azithromycin;
Clarithromycin; Erythromycin). The annual benefits from a reduced exposure to endocrine
disruptors are estimated at €163 billion. This is due to the fact that endocrine disruptors in
Europe contribute substantially to neurobehavioral deficits and diseases, as well as to
childhood obesity, costing costs €1.54 billion annually.
Avoided/reduced impacts on pollinators and agriculture (Acetamiprid, Clothianidin,
Imidacloprid, Thiacloprid, Thiamethoxam, Bifenthrin, Deltamethrin Esfenvalerate,
Permethrin) account for approximately €14.6 billion annually. Costs for packages of
measures such as source control, pathway disruption and end-of-pipe are significant, but they
tend to be lower after initial investment or one-off costs, while health and environmental
benefits are recurring. Examples of costs are pathway disruption for glyphosate (buffer
strips), estimated at around €285 million. Additional controls and treatment for farmed
animal use of deltamethrin could cost around €185 million.
The following substances have “balanced” impacts: Ibuprofen, Nicosulfuron, Clothianidin,
Bisphenol A, and Silver and are suggested for inclusion.
For silver, costs of listing are expected to be high but comparable to the benefits. This is in
particular related to its role in avoiding antimicrobial resistance of bacteria (see also
pharmaceuticals sections related to AMR). Water can be a reservoir of bacteria resistant to
the silver due to the presence of silver as pressure, and/or bacteria that are co-resistant to both
antibiotics and silver (bacteria share the same mechanism of the resistance). Since silver has
antimicrobial effects comparable to pharmaceuticals similar costs are assumed to occur for
silver73
(around €1.5 billion/year based on healthcare costs and productivity losses). Similar
to pharmaceuticals, without action AMR related costs will likely increase also increase 14-
fold by 2050, resulting in annual AMR related costs of around 21 billion by 2050. Therefore,
this substance is also suggested for inclusion on the PS list.
71
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6929930/
72
https://www.oecd.org/health/Antimicrobial-Resistance-in-the-EU-EEA-A-One-Health-Response-March-2022.pdf
73
State of the art on the contribution of water to antimicrobial resistance: Sanseverino eta al., 2018,
https://publications.jrc.ec.europa.eu/repository/handle/JRC114775
EN EN
These benefits and costs apply do not arise exclusively from this initiative, but would be the
result of joint EU and Member State action, based on all policy instruments that address these
pesticides and antimicrobials.
Table 7.1.1: Pollutants considered for addition to the Priority Substance list – preferred
option
Substances Policy option Environmental
impacts
Economic
impacts
Social
impacts
Effectiveness
Efficiency
Coherence
Justification
Pref
erre
d
opti
on
Estrogenic
hormones
17-alpha-ethinyl-
estradiol (EE2), 17–
beta-estradiol (E2),
estrone (E1)
Policy Option
1
(individual
addition)
+
+
+
+/
-
-
+
+
++
+
+
Estrogenic impacts on environment are of
EU-wide concern. Pharmaceutical strategy
covers this in part but no other regulatory
drivers. Listing in the EQSD would be an
effective and efficient means to address the
issue and place onus on source control.
Yes
Policy Option
2
(group
addition)
+
+
+
+/
-
-
+
+
++
++
--
The potency, pathway to environment, and
treatment options vary significantly across
the three substances. A group listing would
likely have negative effects for coherence.
No
Macrolide
antibiotics
Azithromycin,
Clarithromycin,
Erythromycin
Policy Option
1
(individual
addition)
+
+
- --
+
+
+
++
+
++
The pharmaceutical strategy highlights
strong concerns over anti-microbial
resistance (AMR). The strategy largely
address use and control at source.
Environmental monitoring is a weaker
element. Addition to the EQSD would
address this issue and therefore has positive
elements for effectiveness, efficiency, and
coherence. Alternatives exist but can assume
negative impacts for society from more
limited access and use
Yes
Policy Option
2
(group
addition)
+
+
- --
+
+
++
+
++
The potency, and treatment options vary
significantly across the three substances. A
group listing would likely mean
compromise on treatment and reduced
effectiveness.
No
Other
pharmaceutical
Carba-
mazepine
Policy Option
1
(individual
addition)
+
+
+
+/
-
+/
-
+
+
+
++
+
+
Distance to target is large, with the EQS
dossier highlighting EU-wide concerns. This
suggests a large positive impact from listing.
Alternatives do exist (although many are
more expensive), suggesting control of
releases through limitations on use should
be cost neutral. Environmental monitoring
likely key to help manage and control the
issues. Suggests strong positives for
effectiveness and efficiency.
Yes
Diclofenac
Policy Option
1
(individual
addition)
+
+
+
+
+/
-
+
+
+
++
+
+
Targeted consultation suggests that this
substance is the highest environmental
concern of all candidate pharmaceuticals.
Strong environmental benefits of listing.
Alternatives exist and treatment options
look reasonable. Similar to carbamazepine
environmental monitoring needed to help
track and control the issue. Strong benefits
for effectiveness and efficiency of listing
under the EQSD.
Yes
EN EN
Substances Policy option
Environmental
impacts
Economic
impacts
Social
impacts
Effectiveness
Efficiency
Coherence
Justification
Pref
erre
d
opti
on
Ibuprofen
Policy Option
1
(individual
addition)
+
+/
-
-
+
+
+
++
+
+
Distance to target is set at medium, with the
environmental benefits of listing suggesting
a small positive benefit. Other alternatives
are available on the market suggesting costs
could be neutral. The bigger concern is that
use is increasing suggesting environmental
concentrations may also increase. A listing
could be an effective and efficient means of
tracking and controlling release and
environmental concentrations.
Yes
Neonicotinoid
pesticides
Acetamiprid,
Clothianidin,
Imidacloprid,
Thiacloprid,
Thiamethoxam
Policy Option
1
(individual
addition)
+
+
-
+/
-
+
+
++
+
++
++
Primary concern for neonicotinoids relates
to pollinators. However, impacts on aquatic
species, particularly crustaceans is a
concern. Wider protection of the aquatic
environment would be beneficial. Actions
have already been taken under other
legislation, meaning strong positives for
coherence, particularly the farm to fork
strategy. Where other activities are already
underway and primary concern is
pollinators, expect the effectiveness to have
medium benefits.
Yes
Policy Option
2
(group
addition)
+
+
-
+/
-
+ ++ ++
The regulatory status of the individual
neonicotinoids varies. This means a group
listing would mask some of the granular
data and reduce both effectiveness and
coherence.
No
Pyrethroid
pesticides
Bifenthrin,
Deltamethrin,
Esfenvalerate,
Permethrin
Policy Option
1
(individual
addition)
+
+
+
+
-- -
+
+
+
++
+
++
+
Distance to target was large with the EQS
dossier predicting widespread failures due to
the highly toxic nature of the substances for
aquatic environment. Expect very large
positive benefits for environment. Limited
options for alternatives and high costs for
WWTW expected suggesting medium
negative economic costs. Some of the
substances are already no longer approved
for plant protection products, while there
would be positive coherence outcomes with
the farm to fork strategy.
Yes
Policy Option
2
(group
addition)
+
+
+
+
-- - + + ++
The regulatory status of the four substances
varies, as does the treatment options at
WWTWs. Suggests a group listing would
impact effective management, efficiency,
and coherence negatively.
No
Other
pesticides
Glyphosate
Policy Option
1
(individual
addition)
+
+
+
-
+/
-
+
+
++ +/-
Distance to target is large, noting that this
substance is one of the highest volume
pesticide actives in Europe. The EQS
threshold is based on risks to drinking water
and humans given how widely it is used.
Expect strong environmental benefits. The
effectiveness and efficiency of listing
predicts medium benefits on the grounds
that better monitoring data could help
characterise the issues more fully, but no
specific coherence benefits identified.
Yes
Nicosulfor Policy Option + +/ +/ + ++ + Distance to target is small, primary concern Yes
EN EN
Substances Policy option
Environmental
impacts
Economic
impacts
Social
impacts
Effectiveness
Efficiency
Coherence
Justification
Pref
erre
d
opti
on
on 1
(individual
addition)
- - + could be application by boom-sprayers and
spray drift. Assume small benefits to
environment from listing. Improved
monitoring data could help identify control
options. Assume medium benefits for
effectiveness and efficiency, and small
benefits for coherence with farm to fork
strategy.
Triclosan
Policy Option
1
(individual
addition)
+
+
+/
-
+/
-
+
+
+
++
+
++
+
Remaining use of triclosan is very limited,
however, environmental persistence and
impacts are a concern. Suggesting medium
benefits for environment to better control
the issues. The issues posed largely relate to
existing environmental impacts, suggesting
a listing in the EQSD could be appropriate
and effective. Also adds coherence to the
wider legislative landscape that has aimed to
phase-out use.
Yes
PFAS
Policy Option
1
(individual
addition)
+
+
+
+
--
-
-- - --- --
Approximately 6,000 PFAS substances
exist. A total of 24 were identified as
potential markers. In this case approaching
them individually may be labour intensive
and counter intuitive. Including negative
coherence impacts for how these substances
have been managed under the drinking
water directive.
No
Policy Option
2
(group
addition)
+
+
+
+
--
-
--
+
+
++
+
+/-
Distance to target is large, with significant
environmental concerns, suggesting strong
environmental benefits for listing. Control
and treatment options for WWTWs likely
very costly, suggesting strong negative
economic impacts. However, given that
PFAS largely impacts the aquatic
environment a group listing in the EQSD
could be effective and a more efficient way
to manage the issue than individual listings.
Yes
Bisphenol A
Policy Option
1
(individual
addition)
+
+
+
+/
-
+/
-
+
+
+
++
+
++
+
Distance to target is large, suggesting
strongly positive benefits for environment
with an EQSD listing. Within the wider
legislative network controls are already in
place under REACH and IED, but the issue
may relate to in-use stocks. A listing in the
EQSD would therefore have coherence
benefits, and likely reflect strong positive
aspects for effectiveness and efficiency in
terms of tracking and controlling releases
and concentrations within the aquatic
environment.
Yes
Silver
Policy Option
1
(individual
addition)
+ - --
+
+
+/- +/-
Distance to target was small, suggesting
small environmental benefits. The diffuse
nature of use and pathway to environment
could pose challenges for control, while loss
of some uses (e.g., biocidal) could have
negative impacts for society. The issue is
further complicated by naturally occurring
silver, and the form of silver monitored for
EQS. Questionable about how efficient a
No
EN EN
Substances Policy option
Environmental
impacts
Economic
impacts
Social
impacts
Effectiveness
Efficiency
Coherence
Justification
Pref
erre
d
opti
on
listing would be in terms of addressing the
issues, and no coherence benefits identified
with other legislation. As assume efficiency
and coherence are neutral, but a listing in
the EQSD would at least address some of
the issues, and therefore assume medium
benefits for effectiveness.
As indicated in Chapter 6, there are various reasons to use grouping approaches when adding
substances to the priority substance list.
The assessment shows that, out of the four possible groups identified under this option
(noting that the addition of PFAS as a group has already been included as part of Option 1)
only for the macrolide antibiotics benefits outweigh the costs. Adding these substances as a
group would ensure greater coherence in the approach to AMR. Also, correlations in use,
pathways to environment and measures will result in significant cost savings if managed as a
group. If grouped, possible measures by MS would likely be based on the EQS for
Azithromycin as is expected to show the biggest distance to target.
A grouping approach is not recommended for estrogenic hormones, the neonicotinoid and
pyrethroid pesticides.
For PFAS, the use of a relative potency factor (RPF74
) approach was considered for setting a
group EQS but the scientific justification for that is still too uncertain to be introduced in the
legislation. Consequently, a sum of all PFAS approach analogous to the DWD (see Annex 7
for more information) seems a more appropriate way forward.
7.1.2 7.1.2 Pollutants considered for existing EQS amendment
The assessment resulted in two categories of substances. A first category of substances for
which the re-assessment of the threshold concluded that the benefits of an improved
protection outweigh the costs, or where a less stringent threshold value has only limited
impacts. For those an amendment of the EQS is preferable. The second category consists of
substances for which the review and reappraisal of EQS concluded that additional measures
may be warranted. In this case costs are higher but considered proportionate to the risks. For
this category amendment is still considered preferable.
74
PFOA-equivalent relative potency factors are an indication of the relative toxicity of a PFAS substance compared to PFOA.
EN EN
Table 7.1.2: Pollutants considered for existing EQS amendment – preferred option
Substances
Environmental
impacts
Economic
impacts
Social
impacts
Effectiveness
Efficiency
Coherence
Justification
Prefer
red
option
Pesticides
Chlorpyrif
os
+++ +/- +
++
+
+
+
+
++
+
Evolving science and nomination as POP under the Stockholm
Convention suggests the proposed threshold is appropriate.
Would confer strong environmental benefits, while further use of
EQSD to support other legislation (particularly the POPs
Regulation), would suggest strong benefits for effectiveness,
efficiency, and coherence.
Yes
Cypermet
hrin
+++ -- +
++
+
+
+
+/-
Proposed EQS thresholds are lower than existing ones, leading to
strong environmental benefits. No specific new coherence
benefits identified.
Yes
Diuron +++ - +
++
+
+
+
+
+
Proposed EQS thresholds lower than the existing ones, leading to
strong environmental benefits. Approval of diuron as a pesticide
ended in September 2020, so small coherence benefits from
reducing the EQS threshold.
Yes
Dicofol +/- +
+/
-
+/-
+/
-
+/-
Proposed threshold for dicofol higher than the existing one. Rates
of exceedance are already low so little impact for environment.
Possibly small economic benefits for being able to use analytical
equipment with higher LOD.
Yes
Hexachlor
obenzene
+/- +
+/
-
-
+/
-
+/-
Proposed threshold for higher than the existing one. Rates of
exceedance already low so little impact for environment.
Possibly small economic benefits for being able to use analytical
equipment with higher LOD.
Yes
Heptachlo
r /
Heptachlo
r epoxide
+/- +
+/
-
-
+/
-
+/-
Proposed threshold is higher than the existing one. Rates of
exceedance already low so little impact for environment.
Possibly small economic benefits for being able to use analytical
equipment with higher LOD.
Yes
Industrial
chemicals
Dioxins + - + +/-
+/
-
++
Proposed biota threshold is more strict. Dioxins are already
addressed by a range of legislation (particularly POPs
Regulation). Stricter controls have coherence benefits with aims
of POPs Regulation and provide environmental and societal
benefits (food-chain) from a reduced EQS.
Yes
Fluoranth
ene
+/- +
+/
-
+/-
+/
-
+/-
Proposed threshold is higher than the existing one. Rates of
exceedance are already low so expect little impact for
environment. Possibly small economic benefits for being able to
use analytical equipment with higher LOD.
Yes
Hexabrom
ocyclodod
ecane
+/- +/-
+/
-
+/-
+/
-
+/-
Amendment of EQS justified through latest evidence. In reality it
will not have a material impact on environmental protections,
economics, or society.
Yes
Hexachlor
obutadien
e
++ +/-
+/
-
+/-
+/
-
+/-
Amendment would lower EQS. This would provide
environmental benefits. The current distance to target is small but
could be expected to include a wider number of waterbodies with
exceedances. Assume the benefits would be medium positive.
Yes
Nonyl
phenol
+ +
+/
-
+/-
+/
-
+/-
Amendment would lower EQS. This would provide
environmental benefits. Current distance to target small but could
be expected to include a wider number of waterbodies with
exceedances. Assume benefits will be medium positive.
Yes
PAHs ++ - + +/-
+/
-
++
Amendment would lower EQS. Distance to target already
medium, therefore medium positive environmental benefits.
Given potential for PAHs to bioaccumulate better controls would
have societal benefits (food-chain). Also expect small negative
economic benefits if more advance analysis is needed to achieve
the LOD/LOQ.
Yes
PBDEs + - + +
+/
-
+
Amendment would lower EQS for biota (via secondary
poisoning). Distance to target already large, with other legislation
listing proposals to also reduce critical thresholds. In particular
the low POP content for waste under the POPs Regulation. Small
Yes
EN EN
Substances
Environmental
impacts
Economic
impacts
Social
impacts
Effectiveness
Efficiency
Coherence
Justification
Prefer
red
option
positive benefits for coherence, and societal (food-chain).
Tributylti
n
+ +/-
+/
-
+
+/
-
+/-
Proposed EQS more strict than the existing one. Therefore
positive benefits for environment, and effectiveness of the
EQSD.
Yes
Metals
Mercury +++ --
+
+
+ + +/-
Amendment would add an annual average EQS (currently only
MAC). Distance to target large, and greater control to manage
the issues needed. Would lead to strong environmental benefits
because it provides more granularity. Medium benefits for
society through improved protections, small benefits for
effectiveness and efficiency, because annual average EQS
threshold aligns mercury with other priority substances.
Yes
Nickel ++ --
+/
-
+
+/
-
+/-
Amendments for nickel would lower thresholds. Existing
distance to target is medium, with potentially more water bodies
failing to meet good chemical status. Medium positive benefits
for environment expected, and small benefits for improved
effectiveness. Negative economic impacts for greater use of
controls and POMs.
Yes
For the following substances the benefits of an EQS amendment outweigh the costs: Dicofol;
Diuron; Heptachlor/heptachlor epoxide; Hexachlorobenzene; Tributyltin; Dioxins and furans;
Fluoranthene; Hexachlorobutadiene; Nonyl Phenol; PBDEs.
For the substances Chlorpyrifos; Cypermethrin; PAHs; Mercury and Nickel the impact
assessment showed that the overall balance of costs and benefits will be neutral. This is
because the revised EQS is significantly more stringent and thus yields benefits from
increased protection (currently risks are underestimated and therefore additional effort is
warranted) but could also trigger a need for new measures to help achieve the new EQS.
7.1.3 7.1.3 Pollutants considered for deselection from the Priority Substance list
Under this option two different categories are identified: 1) deselection would have more
benefits than costs; 2) the costs and benefits are more balanced.
Table 7.1.3: Pollutants considered for deselection from the PS list – preferred option
Substances
Environmental
impacts
Economic
impacts
Social
impacts
Effectiveness
Efficiency
Coherence
Justification Prefe
rred
optio
n
Pesticides Alachlor +/- + + + + +/
-
Fully meets deselection criteria, which would assume no
negative impacts for the environment if deselected. Small
positive benefits in cost savings, and for society, effectiveness,
and efficiency (redeployment of resources for other
substances).
Yes
Chlorfen +/- + + + + +/ Fully meets deselection criteria, so no negative impacts for the Yes
EN EN
Substances
Environmental
impacts
Economic
impacts
Social
impacts
Effectiveness
Efficiency
Coherence
Justification Prefe
rred
optio
n
vinphos - environment if deselected. Small positive benefits in cost
savings, as well as for society, effectiveness, and efficiency
(redeployment of resources for other substances).
Simazin
e
+/- + + + + +/
-
Fully meets deselection criteria, so no negative impacts for the
environment if deselected. Small positive benefits in cost
savings, as well as for society, effectiveness, and efficiency
(redeployment of resources for other substances).
Yes
Industria
l
chemicals
Carbon
tetrachlo
ride
+/- + + + + +/
-
Fully meets deselection criteria, so no negative impacts for the
environment if deselected. Small positive benefits in cost
savings, as well as for society, effectiveness, and efficiency
(redeployment of resources for other substances).
Yes
Trichlor
obenzen
es
+/- + + + + +/
-
Largely meet deselection criteria but still in use. Based on very
low exceedance rates deselection would have neutral impacts
for the environment. Also provide benefits in terms of cost
savings and redeployment to other substances. Potential issue
due to loss in the time series if releases increased in the future.
No
The substances Alachlor, Simazine and Chlorfenvinphos (herbicides) are placed in the first
category. They are banned in the EU for many years, and concentrations above the EQS are
identified in only a limited number of water bodies. The overall risk to the environment is
considered to be low. Deselection could free up resources that can be reallocated to emerging
risks. The deselection of substances is likely to bring cost savings estimated at €3.8 m- €11.7
million per year.
Trichlorobenzenes (solvents and chemical intermediates) are placed in the second category.
Their use is ongoing, and the substances are acutely toxic to the aquatic environment. The
rates of exceedance are not very high, but deselection is more questionable than for the other
substances given the risk quotient RQ and its MSFD relevance. To maintain protection, this
substance could be monitored as a RBSP where needed. Consequently, trichlorobenzenes are
not proposed for deselection.
All substances have in common that, even if they were removed from the PS list, they might
still be relevant as RBSPs, and MS could decide to continue monitoring them at national level
where needed.
7.2 7.2 Groundwater
Table 7.2.1: Pollutants for addition to GWD Annexes I and II – preferred option
EN EN
Substances
Environmental
impacts
Economic
impacts
Social
impacts
Effectiveness
Efficiency
Coherence
Justification
Prefer
red
option
PFAS
Policy
Option 1
(Annex I
addition as
group of
specific
substances)
Soils:
+++
Carbo
n: --
---
(mitig
ation
meas
ures)
+++
(avoi
ded
costs
DW,
health
care)
++++ ++ ++++ ++++
Carbon intensive remediation and
reduced low cost organic material
for soils are negative, whilst
improved ecosystem health and
reduced soil pollution are
environmental benefits.
Economically the cost of disposal
is high, but balances with the cost
of avoided health treatment and
drinking water treatment for the
listed PFAS. Socially health
impacts are very large, but this is
only effective and efficient for the
specific PFAS. Strong coherence
with the DWD / EQSD.
Yes
Policy
Option 2
(Annex I
addition as
group of all)
Soils:
++++
Carbo
n: ---
----
(mitig
ation
meas
ures)
++++
(avoi
ded
costs
DW,
health
care)
+/- +++ +++ +++
Carbon intensive remediation and
reduced low cost organic material
for soils are negative, whilst
improved ecosystem health and
reduced soil pollution are
environmental benefits.
Economically the cost of disposal
is high, but balances with the cost
of avoided health treatment and
drinking water treatment for all
PFAS. Socially health impacts
are very large (more than Policy
Option 1). Strong coherence with
legislation but goes further.
No
Policy
Option 3
(Annex II
addition)
---- +/-
Healt
h &
Equin
e
indust
ry: --
AMR
/
Chro
nic
ingest
ion:
++
Miner
al
water
: ++
-- +/- +
Environmentally effective only
where included in GW risk is
identified and will not provide the
same level of protection at the
Europe wide level. The ubiquitous
nature of PFAS suggests that this
will not be an effective policy
option. Not coherent with other
legislation.
No
Phar
mace
utical
s
Policy
Option 1
(individual
Annex I
addition)
+ -
Healt
h: ---
Fishe
ries:
+
Miner
al
water
: ++
-/+ + +
Small scale environmental and
economic impacts restricted to the
listed substances. Social impact
on health & Equine industry
(restriction in use) versus
potential for reduction in chronic
ingestion and AMR. Effectiveness
uncertain as human health may be
more important than impacts.
Coherence with aims of EU Green
Deal reductions in AMR.
Yes
EN EN
Substances
Environmental
impacts
Economic
impacts
Social
impacts
Effectiveness
Efficiency
Coherence
Justification
Prefer
red
option
Policy
Option 2
(Annex I
addition as
group of all)
+++ -- +/- ++ +++ +
Large scale environmental impact
and moderate economic impact
from investment in green
pharmacy measures. Social
impact human health and
veterinary medicines (restriction
in use) versus health benefits of
reduction in chronic ingestion and
AMR. Supported by returns
schemes but effectiveness
uncertain as human health may be
more important than impacts.
Coherence with aims of EU Green
Deal reductions in AMR in soils.
No
Policy
Option 3
(Annex II
addition)
--- +/-
Farmi
ng: -
Miner
al
water
: ++
-- +/- +
Little impact on reducing levels in
GW across Europe and little
change in terms of economic
impact. Social impacts will be
localised to where an issue has
been identified.
Only
for
primid
one
nrMs
Policy
Option 1
(individual
Annex I
addition)
++ -
Farmi
ng: -
Miner
al
water
: +++
++ ++++ +++
Environmental impacts include
reduced drinking water treatment,
healthier GW ecosystems (and
services such a denitrification).
Economic impacts will be the
costs of finding new parent
products and legacy clean up.
Social impacts will include the
challenge to pesticide industry
and farming for authorisations and
restriction of use, whilst the water
bottling and fisheries sectors will
benefit. Efficient for group
identified. Coherent with EU
Green Deal but goes beyond
DWD.
Yes
Policy
Option 2
(Annex I
addition as
group of all)
+++ -- +/- +++ + +++
Environmental impacts include
reduced drinking water treatment,
healthier GW ecosystems (and
services such a denitrification).
Economic impacts will be the
costs of finding new parent
products and legacy clean up.
Social impacts will include the
challenge to pesticide industry
and farming for authorisations and
restriction of use, whilst the water
bottling and fisheries sectors will
benefit. Efficiency is uncertain
due to the GW timelag. Coherent
with EU Green Deal but goes
beyond DWD.
No
Policy
Option 3
(Annex II
---- +/- +/- -- +/- +++
Small impact on reducing levels
at European scale means
environmental impacts are low
No
EN EN
Substances
Environmental
impacts
Economic
impacts
Social
impacts
Effectiveness
Efficiency
Coherence
Justification
Prefer
red
option
addition) with minimal change to
investment in analysis and
mitigation measures. Localised
social impacts where used is
restricted. Coherent with the
DWD but not with the EU Green
Deal. Option is ineffective and
inefficient at dealing with the
issue at the EU scale.
Of all options, Option 3 (all PFAS in Annex II, TVs to be possibly set at MS level) not only
provides the weakest protection of groundwater, but would also result in a fragmented
approach per MS. Given the widespread pollution of PFAS in groundwater and the societal
and environmental impacts, EU harmonised action is essential.
For Option 1 (group of 24 PFAS in Annex I) the distance to target is large, meaning that the
concentrations in a large number of locations will likely exceed the proposed GW QS in a
large number of MS. While the distance to target is similar for Option 2, a simple sum of all
PFAS approach is suggested in order to future-proof the legislation. As the distance to target
is similar, the types of implementing measures (requiring action on both point and diffuse
pollution) would be similar for both options and costs and benefits would also be within the
same ranges.
Option 2 are considered in line with the current DWD, but Option 2 would not “future proof”
the legislation in terms of the remaining PFAS substances and is therefore not considered
protective enough of public health. On this basis Option 1 is selected as the preferred option
for PFAS. The latest EFSA opinion on the maximum tolerable intake also points in this
direction.
The assessment, the SCHEER opinion and the results of the stakeholder consultation give a
preference to Option 1 (add carbamazepine and sulfamethoxazole to Annex I, with individual
GW QS). This option has generally smaller costs than Option 2 (adding the two substances as
a group). Option 1 will lead to a reduced pollution of groundwater and positive impact on
shellfish and fisheries where groundwater inputs to rivers and estuaries are of considerable
importance. Product substitution is considered as a viable option for Sulfathemoxazole, but
less for Carbamazepine. MS will likely not take measures such as the treatment of biosolids
only for these two pharmaceuticals as that would be disproportionately expensive but rather
turn to ‘Green Pharmacy’75
initiatives or other source control and pathway disruption
measures.
The assessment also showed that there is enough evidence for Primidone76
to be added to
Annex II77
(i.e. partly implementing Option 3), which would not have a large impact on costs
75
Green pharmacy – a narrative review: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6296717/#b1-cm-91-391
76
During the period of the SCHEER review, the Groundwater Watch List dataset was supplemented with additional data following a
SCHEER request.
EN EN
or benefits. Adding Primidone means that MS have to establish suitable threshold values for
this substance at national level.
Most of the parent pesticides of the 16 nrMs identified are already banned. For the remaining
parent pesticides, a number of strategies and legislation at EU level will drive down pesticide
use, as well as national action plans under the SUPD78
. Stakeholder feedback suggests that
there is a common understanding that nrMs are widely found in groundwater in worrying
concentrations and that the emissions of the parent substances need to be limited.
The distance to target assessment suggests that options 3b (all nrMs as a group in Annex I)
and 3c (all nrMs as a group in Annex II) are likely to maintain the status quo and no
additional measures beyond those identified under the dynamic baseline scenario are needed.
Option 3e (all nrMs in Annex I with lower GW QS) are coherent with that. Given that the 16
nrMs are already detected in groundwater, there is a risk of further substances detected in
future at levels of concern. Option 3e extends the more stringent GW QS to all nrMs of
pesticides and thus future proofs legislation, whilst following the precautionary principle: it
should therefore be selected.
7.3 7.3 Monitoring, reporting and administrative streamlining options
Error! Reference source not found. summarises the impacts of implementing the
monitoring, reporting and administrative streamlining options, compared to the status quo.
The options presented are not mutually exclusive.
Table 7.3.1: Monitoring, reporting and administrative streamlining – preferred options
Policy
option
Sub-option
Environmental
impacts
Economic
impacts
Social
impacts
Effectiveness
Efficiency
Coherence
Justification
Preferr
ed
option
Option 1:
Provide /
improve
guidance
and
advice on
monitorin
g
a) Guidelines on
applying
innovative
methods.
+/- +/- + +/- +/- ++++
Impacts on environment / economy
neutral as depending on uptake from
MS. Similarly, effectiveness and
efficiency will depend on the extent of
investment and uptake. Option coherent
with provisions of WFD
No
b) Improve
existing
guidelines on
EBMS.
+/- +/- + +/- +/- ++++ As above Yes
c) Harmonised
monitoring
methodology
and guidance
for
+/- +/- + +/- +/- ++++ As above Yes
77
During the March 2022 stakeholder workshop, participants concluded that from the 9 pharmaceutical substances (Clopidol, Cortamiton,
Amidozoic Acid, Sulfadiazine, Primidone, Sotalol, Ibuprofen, Erythromycin, Clarithromycin) considered on the Groundwater Watch List
only for Primidone there was enough evidence to consider inclusion at this point in time.
78
COM(2022) 305, proposal for a regulation on the sustainable use of plant protection products.
EN EN
Policy
option
Sub-option
Environmental
impacts
Economic
impacts
Social
impacts
Effectiveness
Efficiency
Coherence
Justification
Preferr
ed
option
microplastics.
d) Guidelines on
sampling
frequency for
PS and
RBSPs.
+/- +/- + +/- +/- ++++ As above No
e) Repository
for sharing
best available
monitoring
technique
practices MS.
+ ++ ++ +/- +/- ++++
Impacts on environment / economy and
social positive as it enables knowledge
sharing. Efficiency positive as long term
benefits outweigh investment due to
savings in unsuccessful approaches.
Effectiveness depends on use of MS.
Coherent with WFD
No
Option 2:
Establish
/ amend
obligator
y
monitorin
g
practices
a) Obligation in
EQSD to use
EBMs to
monitor
estrogens.
+++ - +++ ++++ +/- ++++
Economic impacts high but benefits to
environmental and society significant.
Effectiveness very high, whereas the
cost/benefit ratio means a neutral rating.
Coherent with WFD
Yes
b) Obligatory
Groundwater
Watch List
mechanism.
+++ - +/- ++++ ++ ++++
Obligation for monitoring would inquire
costs, but have significant
environmental benefits in short term,
and likely social in long term.
Effectiveness and efficiency very
positive as monitoring stations already
in place. Option coherent with WFD
Yes
c) Improve
monitoring
and review
cycle of
Surface
Water Watch
List
++ +/- +/- ++ + ++++
Significant environmental benefits and
reduced reporting burden likely
outweigh possible costs of monitoring.
As such, effectiveness considered
medium. Efficiency small positive as
administrative costs are compensated by
decrease in frequency of updating list.
Option coherent with WFD
Yes
Option 3:
Harmonis
e
reporting
and
classificat
ion
a) Harmonised
digital
reporting /
automated
data delivery
mechanism.
+ - + +++ + ++++
Significant benefits in the long run,
however substantial cost implications
involved. As such, the effectiveness is
high but the efficiency remains positive,
but small as the benefits would
outweigh cost but only through time.
The option is coherent with provisions
of the WFD
Yes
b) Reference list
of EQS for
RBSPs and
incorporate
RBSPs into
assessment of
chemical
status
+/- -- +++ +++ ++ ++++
Negative impact due to substantial costs
MS for implementation and costs for
economic actors taking measures.
However, positive impacts through
harmonization allowing more effective
measures and providing equal standard
of water resource leads to high
effectiveness. Benefits will outweigh
costs thus efficiency also positive.
Yes
EN EN
Policy
option
Sub-option
Environmental
impacts
Economic
impacts
Social
impacts
Effectiveness
Efficiency
Coherence
Justification
Preferr
ed
option
Option 4:
Legislativ
e and
administr
ative
aspects
a) Update lists
of SW and
GW
pollutants by
delegated
acts.
+++ +/- +++ + +++ ++++
Cost of measures to be taken and minor
costs associated to delegated acts but
balanced by stimulating innovation and
possible improvement in
competitiveness. Environmental and
social impacts very positive leading to
positive efficiency rating. Effectiveness
will depend on which pollutants are
actually integrated.
Yes
b) Change status
of ‘eight other
pollutants’ to
that of
PS/PHS.
+ - ++ ++ ++ ++++
Five of eight other pollutants are POPs
under Stockholm Convention, therefore
option increases consistency and
improve efficiency and effectiveness
with their management. Three other
substances are solvents with known
CMR properties, for which water
protection currently not addressed.
Addition tri and tetrachloroethylene
would have strong coherence benefits to
REACH and solvent emissions
directive.
Yes,
except
carbon
tetrachl
oride
(see SW
option
4)
c) Change status
some existing
PS to that of
PHS.
n/a n/a n/a ++++
PHS status coherent as follows: PCP
(to become PHS along with other POP
under Stockholm Convention);
Fluoranthene (grouped with other
PAHs recognised as POPs under the
Convention on Long-Range
Transboundary Air Pollution); .
Lead (other metals of similar class are
already PHS); 1,2 dichloroethane
(‘sufficient concern at community level’
as in REACH); the two Octylphenol
substances (coherence REACH and
sufficient concern at community level)
Yes
8 8 PREFERRED POLICY PACKAGE
8.1 8.1 Preferred options summary
The preferred policy options are aggregated in Table 8.1.1 below. The package of options all
surface and groundwater options and the digitalisation, administrative streamlining and better
risk management options marked as preferred in the preceding chapter.
EN EN
Table 8.1.1: Preferred policy initiatives
Surface water
Option 1: Addition to PS list as an individual
substance with EQS set for each individually
24 individual substances:
17-Beta estradiol (E2); Acetamiprid; Azithromycin; Bifenthrin;
Bisphenol A; Carbamazepine; Clarithromycin; Clothianidin;
Deltamethrin; Diclofenac; Erythromycin; Esfenvalerate; Estrone (E1);
Ethinyl estradiol (EE2); Glyphosate; Ibuprofen; Imidacloprid;
Nicosulfuron; Permethrin; Silver; Thiacloprid; Thiamethoxam;
Triclosan, Silver
Option 2: Addition to PS list as a group with
EQS set for “total” and/or “sum of”
PFAS (sum of 24 named substances)
Option 3: Amendment of existing EQS
14 substances to more stringent:
Chlorpyrifos; Cypermethrin; Dicofol; Dioxins; Diuron; Fluoranthene;
Hexabromocyclododecane (HBCDD); Hexachlorobutadiene;
Mercury; Nickel; Nonyl Phenol; PAHs; PBDEs; Tributyltin
2 substances to less stringent:
Heptachlor/heptachlor epoxide; Hexachlorobenzene,
Option 4: Deselection
4 substances: Alachlor; Carbon tetrachloride; Chlorfenvinphos;
Simazine
Groundwater
Option 1: Addition to Annex I with GW QS
set for each individually
2 pharmaceutical substances: Carbamazepine and Sulfamethoxazole
All nrMs with individual GW QS of 0.1 µg/l
Option 2: Addition to Annex I with GW QS set
for “total” and/or “sum of”
PFAS (sum of 24 named substances)
Option 3: Addition to Annex II 1 substance: Primidone
Digitalisation, administrative streamlining and better risk management
Option 1: Provide guidance and advice
on monitoring
b
Improve existing EBM guidelines to improve monitoring of
groups/mixtures of pollutants by using EBMs. .
c
Develop a harmonised measurement standard and guidance for
microplastics in water as a basis for MS reporting and a future listing
under EQSD and GWD.
Option 2: Establish/amend obligatory
monitoring practices
a Include an obligation in the EQSD to use EBMs to monitor estrogens.
b
Establish an obligatory Groundwater Watch List analogous to that of
surface waters and drinking water and provide guidance on the
monitoring of the listed substances.
c
Improve the monitoring and review cycle of the Surface Water Watch
List so that there is more time to process the data before revising the
list.
Option 3: Harmonise reporting and
classification
a
Establish automated data delivery mechanism to ensure easy access at
short intervals to monitoring/status data to streamline and reduce
efforts associated with current reporting, and to allow access to raw
monitoring data.
b
Introduce a repository of environmental quality standards for the
RBSPs as an Annex to the EQSD, and incorporate RBSPs into the
assessment of surface waters’ chemical status.
Option 4: Legislative and administrative
aspects
a
Use EQSD instead of WFD to define the list of Priority Substances,
and update the lists of SW and GW pollutants by Comitology or
delegated acts.
b
Change the status of Aldrin, Dieldrin, Endrin, Isodrin, DDT,
Tetrachloroethylene and Trichloroethylene from ‘other pollutants’ to
that of Priority Substances.
c
Change the status of 1,2 dichloroethane, fluoranthene, lead,
octylphenol ethoxylates and pentachlorophenol to that of Priority
Hazardous Substances.
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8.2 8.2 Overall magnitude of impacts
The proposed policy package ensures that legislative changes remain proportionate, i.e. that
societal and environmental benefits are larger than economic costs incurred and that the
issues are best addressed at EU level. An overview of direct and indirect costs and benefits
associated with the options is provided in Annex 3.
As set out in the introduction to section 6 it is not possible, in this impact assessment, to
identify the isolated cost and benefit of listing substances since this will depend on measures
chosen by MS and on distance to target in the concerned water bodies. Moreover, water
legislation works in sync with other legislation (waste water treatment, source control,
international requirements, etc). Figures mentioned are therefore often related to estimated
costs / benefits from groups of substances with similar characteristics or effect.
For surface water, significant direct adjustment costs are expected for instance from the fact
of adding ibuprofen, glyphosate, PFAS, Bisphenol-A and Silver to the PS list, as well as from
the amended EQS of PAHs, mercury and nickel. In relation to groundwater, the most
significant costs are expected for PFAS, associated with the restriction of use (e.g. in fire-
fighting foams - up to €390 million/year per substitute use) and the management of
contaminated bio-solids (up to €755 million/year for incineration and €201 million/year for
landfilling at EU level). The cumulative costs of the preferred digitalisation, administrative
streamlining and better risk management options are of an administrative nature, initially
materialising at EU level and generally low (below €1 million), with the possible exception
of the automated data delivery mechanism.
It is worth noting that costs cannot be attributed solely to this initiative, due to inevitable
interactions and synergies with many other EU policies tackling the same substances. The
costs of pollution are mostly internalised through the IED and the UWWTD, the future ban
on all PFAS except in essential uses, the implementation of the microplastics initiatives and
others. For example, the revision of the UWWTD will boost the upgrade of many UWWTPs,
and introduce extended producer responsibility (EPR) to cover the costs, which will
significantly reduce the load of micropollutants (like pharmaceuticals and microplastics)
entering surface and groundwaters.
The proposed initiative will contribute to the benefits of water policy primarily by reducing
concentrations of acutely toxic and/or persistent chemicals in surface and groundwater. It will
also improve the value of the aquatic ecosystems and of the services they deliver. However,
the valuation of these benefits is challenging. First, this is because it is difficult to attribute
benefits to specific measures. Many measures are multifunctional and have multiple benefits
that contribute to the objectives of several policies. A second challenge is that the evaluation
of benefits requires taking account of various non-quantifiable and location-specific factors,
which limits the potential for aggregation and accurate monetisation (this is the case in
particular for ecosystem services).
Nevertheless, this impact assessment concludes that overall benefits for society outweigh
costs considerably, based on reduced impacts on the environment, human health, pollinators
and agriculture, as well as avoided costs of water treatment. For example, annual healthcare
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costs related to endocrine disruptors’ exposure are estimated to be €163 billion, whereas
hypertension brought about by background PFAS exposure contributes to an estimated €10.7-
35 billion of annual health costs. The annual health benefits from lowering the risks of PFAS
exposure are estimated to be at least €52-84 billion in the EEA countries. The annual avoided
costs from not using reverse osmosis to remove PFAS from DW are estimated to be at least
€9.13 billion. Not having to use reverse osmosis would also lower by 20% the amount of
water extraction needed to produce drinking water. In addition, the annual costs associated
with treating BPA-containing leachate from landfills are estimated at around €103.7 million
(assuming 25-year lifetime), whilst the costs of end-of-pipe removal of microplastics from
waste water are estimated to be between €0.76-3.14 billion per year. Regulating background
levels of these chemicals in surface and groundwater bodies is important to drive down
emissions, hence avoiding or significantly reducing these costs. When assessing the annual
health benefits from the health and environmental effects of nanosilver79
the possible role of
silver in antimicrobial resistance is a relevant issue and is therefore included.
These costs and benefits should be understood as the joint result of all policy actions by EU
and Member States that address the concerned pollutants, and should therefore not be seen as
the result of this initiative alone.
The preferred policy package will result in water quality improvements contributing to the
achievement of the main objective of this review, in line with the Zero Pollution and
Biodiversity targets. As water quality issues (especially those caused by emerging pollutants)
have a clear cross-border dimension, they need to be addressed at EU level to ensure a
uniform level of protection for EU citizens and ecosystems. Considerations of proportionality
have been embedded into the legislative review so that decisions are guided by the presence
(or absence) of an EU-wide risk. Where no such risk was identified, flexibility was left for
MS to set their own TVs.
8.3 8.3 One In, One Out
In the context of the ‘one in, one out’ approach to which the Commission committed, it is
important to pay specific attention to the costs and implications to business, especially small
and medium sized enterprises. Costs to business, including the agriculture sector related to
this initiative include: (i) administrative costs; (ii) costs related to fertiliser and pesticide
management, adjusted feed techniques and sampling, and waste water treatment; (iii) taxes
and fees for the cost recovery of water services and activities with a significant impact on the
environment; and (iv) in certain cases, costs of substitution. Costs on business and
administration will be felt more upstream due to the need to limit emissions during
production or find substitutes for certain substances. Benefits may be felt rather by business
downstream, such as the waste water treatment sector and the drinking water producers, as
well as water users such as farmers and building sector.
Administrative costs cannot be assessed at the level of businesses, since MS will take very
different measures to comply, considering the characteristics of the water body and the
distance to target of the substances proposed for listing. Administrative expenses at EU level,
79
Based on scientific opinions of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on ‘Nanosilver:
safety, health and environmental effects and role in antimicrobial resistance’ (https://health.ec.europa.eu/system/files/2016-
11/scenihr_o_039_0.pdf) from 2014 and SCCS (2018) opinions
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in particular those linked to the monitoring, reporting and administrative simplification
options, are specified in section 6. Those costs range from € 1.9 to 2.3 million for the
guidances (effect based methods), methodology for microplastics, repository of RBSPs and
groundwater watchlist analysis, of which €1 million is annually recurring. Administrative
expenses at MS level associated with monitoring pollution are overall expected to increase,
due to the increased number and different nature (like microplastics and groundwater) of
substances covered by the legislation. Cumulative costs are estimated between €9 and 15.1
million annually across the EU-27 (thus estimated at around 0.33 million to €0.55 million per
year per MS). Both the European Environment Agency and the European Chemicals Agency
will be tasked to carry out tasks on the water quality data access and the risk assessment of
pollutants respectively, leading to annually recurring costs in the form of additional staff.
8.4 8.4 REFIT
In line with the FC of 2019 and with the more holistic Monitoring Framework put in place by
the 8th
Environmental Action Programme, several elements of the existing Directives will be
clarified and simplified in the legislative proposal on the basis this IA. This concerns notably
the requirements related to reporting and data sharing. An improved collection of digital
information at EU level which allows improved understanding of pollutants in EU waters
(and so better targeting of measures), is likely to reduce the administrative burden of MS in
the medium-long term. In addition, through digitalisation the comparability of MS data can
be more closely aligned, ultimately increasing the transparency of data by publishing them on
an online, centralised platform. This would also be beneficial for increased compliance of MS
with provisions of the EU INSPIRE Directive, e.g. by using the INSPIRE Geoportal for this
purpose. Digitalisation also helps to act independently of reporting timeframes, thus making
data available more often and closer to real time. This would be beneficial for MS authorities,
to demonstrate progress at national scale, and better empower civil society too.
The revised Directives will introduce monitoring obligations for the newly listed substances
while removing the obligations related to deselected substances. The extent to which the
monitoring obligations trigger follow-up actions to reduce the emissions of those substances
is limited to water bodies that are not in good status already (currently 59% of surface waters
(11) (97)). In these cases, MS are obliged to take additional measures to ensure their surface
water bodies achieve good chemical status.
The Impact Assessment has differentiated this picture by assessing the expected ‘distance to
target’ according to the type of pollutants (see Chapter 0). This revealed that for 13 of the 24
substances or substance groups included in the preferred policy package as additions and for
10 of the 15 substances or substance groups for which a change in EQS values is proposed,
the expected distance to target is small to medium. Consequently, for these substances only
limited or no additional measures are expected.
A relatively large distance to target is expected only for 10 of 24 (groups of) substances
proposed for addition, namely PFAS, four pyrethroid insecticides (Deltamethrin,
Esfenvalerate; Permethrin; Bifenthrin), Glyphosate (herbicide), Bisphenol-A (industrial
chemical), Silver, and three pharmaceuticals (Carbamazepine, Diclofenac, Ethinylestradiol
(EE2)). The same is also expected for Mercury and the flame-retardants Polybrominated
diphenyl ethers (PBDEs) for which a change in EQS values is proposed. For Mercury it needs
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to be noted that this is a ubiquitous substance which is already causing failure to achieve
good status in a large number of water bodies, so a revision of its EQS will likely not
deteriorate the compliance situation significantly.
9 9 HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED?
9.1 9.1 Indicators of success
The following success indicators were identified for the general objectives of this initiative to
help compare the merits of the policy options and facilitate monitoring and evaluation.
1. Increase the protection of EU citizens and natural ecosystems
 Declining concentrations of PS / PHS and ultimately achieving good chemical status
for all EU surface waters, groundwaters and coastal waters.
 An agreed EU measuring and monitoring method for microplastics in place by 2025
 A more effective surface and groundwater watchlist mechanism (e.g. introduction of
an obligatory GW WL mechanism by 2025)
2. Increase effectiveness and reduce administrative burden
 Introducing automated data delivery mechanisms for reporting water monitoring data
 Using delegating acts for future revisions of the list of water pollutants
These indicators will support, and feed into the integrated monitoring of pollution that has
been created by the Commission’s Zero Pollution Action Plan.
9.2 9.2 Monitoring and evaluation under the existing EU water quality legislation
The existing WFD has a 6-yearly reporting cycle. In every cycle, MS report on the state of
water in each river basin to the Commission, through the EEA. The EEA utilises this data to
produce a State of Water report. The monitoring results for individual PS/ PHS feed into
chemical status assessments (pass/fail) per WB. The Commission uses the information to
assess the RBMPs and as a basis to assess compliance with the legislation. MS are required to
report the specific measures they have taken to reduce pressures on water quality. As such
success can be heterogeneous between different WBs. This heterogeneity learns that success
factors also relate to measures in other policy areas. Measures to address mercury levels in
surface water largely depend on measures to tackle Hg-emissions from the combustion of
coal in large combustion plants, and pesticide emissions relate to DSUP measures.
The monitoring and reporting obligations under the WFD will remain the key indicators to
track progress against the objectives of this revision. For surface and groundwater, the
timeliness, and the completeness of reporting, broken down by MS, pressure source and
pollutants, will be the main tools to evaluate and continuously monitor progress. However,
more frequent periodic (and obligatory) reporting and sharing of information by MS will be
introduced as a result of the preferred policy package (e.g. by the mandatory GW WL).
Currently, data reach the public domain with considerable delays. For example, the 2018
EEA State of Water report is based on 2012-2014 data and is, at the time of writing, the most
up to date information publicly available at EU level. While acknowledging that an
assessment of good status (ecological or chemical) is dependent on many different data put
together, better uptake of modern monitoring and digital reporting would allow generating
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those overviews with a higher frequency than every 6 years, feeding into the 8th
EAP
Monitoring Framework and the bi-yearly Zero Pollution Monitoring and Outlook Reports. It
should also be possible to produce data on individual quality elements. This is in line with
digitalisation, administrative streamlining and better risk management options 4 (a repository
for sharing best practices regarding available monitoring techniques and their
implementation) and 5 (an automated data delivery mechanism to ensure shorter intervals of
monitoring, while streamlining reporting).
9.3 9.3 Joint monitoring and evaluation
In addition to the monitoring established under the WFD and the improvements proposed in
this initiative, monitoring of water pollutants in EU laws that address pollution is crucial. In
particular, the monitoring provisions included in the revised Industrial Emissions Portal
(formerly: E-PRTR), UWWTD and other relevant legislation will be used to assess the policy
effectiveness. Currently, the E-PRTR does not require reporting of PFAS emissionsHowever,
PFAS is one category of substances that is envisaged to be added to the Industrial Emissions
Portal Regulation based on the Commission proposal for revision. Automated links with the
most recent lists of water polluting substances under this initiative are envisaged.
This initiative is related to many other work strands under the ZPAP which are ongoing or
only starting to deliver results. By 2025 the Commission will take stock of the degree of
implementation of the ZPAP action plan, building on the second Zero Pollution Monitoring
and Outlook Report. The water quality monitoring in the MS will help evaluate the success of
the present initiative, which will realistically only start to become visible after 2027.
Combining the output and outcome indicators of those pieces of legislation with the impact
indicators set by assessing “good chemicals status” will give a measure of whether the health
and ecosystem benefits have been achieved or where there are gaps in implementation.
Proper monitoring and reporting is key to ensure compliance with the Directive and to allow
EU and MS to adjust policies in case these appear not to deliver the desired effects. In order
for the legislative changes to become operational and effective, compliance at MS level must
be secured. An important part of compliance assurance will be done through sectoral
legislation (IED, UWWTD, Sustainable Use of Pesticides, REACH, Mercury Regulation,
etc.) setting requirements for polluters, but also through the Environmental Liability
Directive and Environmental Crime Directive which are currently under revision. The
existing WFD contains several provisions that, in combination with the above-mentioned
legislation, lay down a comprehensive compliance assurance mechanism. The more
continuous availability of monitoring and status data (a combined effect of policy options 2a,
2b, 5 and 6) both to the European Commission and the general public will increase the
overall enforceability of the legislation. The creation of a mandatory groundwater watch list
(Option 7) will lead to a more structured involvement of stakeholders in prioritising action on
the most harmful substances, likely enhancing their interest in compliance.
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ANNEX 1: PROCEDURAL INFORMATION
1. LEAD DG, DECIDE PLANNING/CWP REFERENCES
The preparation of this impact assessment was led by Unit C1 Sustainable Freshwater
Management within DG Environment, with support from DG Joint Research Centre, Unit D2
Water and Marine Resources. The file concerns the revision of the lists of pollutants and
corresponding regulatory standards under the WFD, EQSD and GWD. These Directives were
evaluated according to Better Regulation guidelines. The Decide planning number is
PLAN/2020/8554 - Revision of lists of pollutants affecting surface and groundwaters.
2. ORGANISATION AND TIMING
2.1. COMMISSION INTERNAL PROCESS - INTER SERVICE STEERING GROUPS
The Inception Impact Assessment Roadmap (98) was published on 23 October 2020 with
feedback period closed on 20 November 2020.
The inter-service steering group (ISSG) for the impact assessment is the same one as for the
Evaluation. It is a shared group with other water and pollution related files: the revision of the
UWWTD, the Evaluation of the SSD and the back-to-back Evaluation and impact assessment
of the Bathing Water Directive. The ISSG includes members from the following DGs: AGRI
(Agriculture), CLIMA (Climate Action), ENER (Energy), FISMA (Financial Stability,
Financial Services and Capital Markets Union), GROW (Internal Market, Industry,
Entrepreneurship and SMEs), HOME (Migration and Home Affairs), JRC (Joint Research
Centre), JUST (Justice and Consumers), MARE (Maritime Affairs and Fisheries), RTD
(Research and Innovation), REGIO (Regional and Urban Policy), SANTE (Health and Food
Safety), SG (Secretariat General), SJ (Legal Service), TAXUD (Taxation and Customs
Union) as well as the EEA (European Environment Agency).
Seven meetings of the ISSG were organised between October 2020 and September 2022, the
final meeting being held on 22 September 2022. The ISSG has been consulted on all major
deliverables for this file, including the inception impact assessment, the stakeholder
consultation, including stakeholder consultation workshops, open public consultation and
targeted experts survey and key deliverables for the support study prior to its submission to
the Regulatory Scrutiny Board. The ISSG that was consulted during this process is identical
to the one involved in the REFIT Evaluation of the Directives.
3. CONSULTATION OF THE RSB
On 15 July 2021 an upstream meeting with the Regulatory Scrutiny Board (RSB) took place.
The RSB provided several comments in relation to this file, centred on the following:
 Need to prevent pollution at the source, enforceability and monitoring of the changes
to the Priority Substances list and clarifications on the applicability of the
precautionary principle;
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 Need to establish a Dynamic Baseline Scenario, allowing to account for implications
of existing and planned EU legislative initiatives (e.g. Human Pharmaceuticals
legislation, Drinking Water Directive, UWWTD, etc.).
The IA was submitted to the RSB on 25 May 2022 and discussed on 22 June. On 24 June the
RSB issued its positive opinion with reservations. The points have been addressed as follows:
RSB ‘What to improve’ How the comment has been addressed
(1) The design of options should allow the
identification of impacts, separately for each option or
their combination. The options and their presentation
should be simplified, and purely technical elements
moved to the Annexes. The report should provide
more aggregated and more relevant options and sub-
options. Options linked to administrative
simplification and burden reduction should be grouped
together.
Presentation of the policy options has been simplified
in section 5 and onwards. In particular the options
aimed at monitoring, reporting and administrative
streamlining have been aggregated to four main
options with sub-options. The link with the overall
objectives has been clarified, in particular in section 5.
(2) The analysis of the impacts on SMEs and citizens
should be further developed. The report should
elaborate on the impacts on SMEs, including in terms
of the compliance costs and administrative burden,
and present the results of the application of the
proportionate SME test. The impacts on consumers
should also be further analysed (indicatively, in
relation to pharmaceuticals, personal care products,
consumers’ health, cost of water services) and the
evidence should be clearly presented for the
conclusions reached. The report should be more
explicit on the implementation deficits in the problem
analysis and examine the different possible impacts
across MS. It should map out the respective efforts
required from different MS to meet the targets set.
The impacts on SMEs has been further developed
throughout the text, from the perspective of the
different groups of pollutants. The SME test has been
used as a guidance but could not be applied in full
because of missing data and the context-specific
nature of the measures to be taken by MS in response
to the legislation.
Information on impacts on consumers for several
categories of products (including personal care
products) has been addressed, in sections 2 and 6.
As regards efforts required from MS, Annex 4
provides more information where the distance to target
is largest and Annex 11 indicates for each substance
which MS have measured exceedances at present.
(3) The report should critically examine the validity of
the benefit and cost estimates presented as the
examples of the potential impacts, provide more detail
on the scope and methods used and indicate how
relevant the examples are to this initiative.
It should strengthen a summary of the results of the
cost benefit analysis, taking into account all qualitative
and quantitative evidence and indicating the overall
order of magnitude of the expected impacts of the
preferred option. Given the link with many existing
and ongoing initiatives, the report should discuss the
relevance and attribution of costs and benefits to this
initiative. Annex 3 should be simplified to integrate in
a concise manner the qualitative and quantitative
evidence. The analysis should reflect any changes to
the options’ structure.
It has been clarified in sections 6 and 8 how the
examples of benefits and costs need to be interpreted,
to avoid the impression that the costs and benefits
quoted are solely linked to measures following from
this initiative.
Annex 5 shows the approximate effect of existing and
future policies on the substances proposed as part of
this initiative.
(4) The report should clarify the costs and cost savings
in scope of the One In, One Out approach. The
dedicated section and Annex 3 seem incomplete. All
costs and benefits related to the One In, One Out
approach should be identified and clearly presented.
The paragraph on One In, One Out in section 8 has
been supplemented with information on the costs of
the monitoring, reporting and administrative
streamlining options. Relevant information has also
been included in Annex 3.
(5) The report should systematically integrate the Section 7 now includes a summary assessment of
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criteria of effectiveness, efficiency and coherence in
the comparison of options.
effectiveness, efficiency and coherence for the options
and sub-options, including a justification for a
particular score on these criteria.
A large number of other improvements have been made as well, in reaction to more detailed
RSB comments as well as other corrections deemed necessary.
4. EVIDENCE, SOURCES AND QUALITY
To support the impact assessment, the European Commission awarded a contract to external
experts. The revision of the lists of pollutants under EQSD, GWD and WFD was prepared by
the Commission’s Joint Research Centre (JRC) which elaborated dossiers for each individual
substance. To draft the scientific dossiers JRC collected data from available EU official
reports (ECHA, RIVM, INERIS, UBA, OEKOTOXZENTRUM, etc.) and collections of data
send by experts and stakeholders. In most cases such dossiers were prepared in consultation
with working groups consisting of experts from MS and stakeholders, allowing each to bring
their expertise to bear on the content of the dossier. In a next step, the Commission consulted
stakeholders through the relevant CIS-working groups. Finally, the Scientific Committee on
Health and Environmental and Emerging Risks (SCHEER) expressed an independent
scientific opinion on the proposed EQSs for each of the dossiers. Preliminary SCHEER
opinions for substances of the "Draft Environmental Quality Standards (EQS) for priority
substances under the WFD and GWD" are published for a 4-week commenting period.
During this period comments were collected and considered, if relevant they were addressed
directly by SCHEER in the final opinion. All substance dossiers both for new candidate PS
and EQS revision substances were submitted to SCHEER for scientific opinion. Below is an
overview of the progress of the work by the SCHEER.
1. Preliminary SCHEER opinions are available for the following substances:
• Nonylphenol, Glyphosate, Nickel, Fluoranthene.
2. Opinions being finalized (comments from public consultation period being processed):
• Ibuprofen
3. Final SCHEER opinions are completed for the following substances:
• Pesticides (Nicosulfuron), Pesticides-Pyrethroids (Bifenthrin, Esfenvalerate,
Permethrin, Deltamethrin); Pesticides-Neonicotoids (Acetamiprid, Clothidianidin,
Thiamethoxam, Thiacloprid, Imidacloprid); Macrolide antibiotics (Azithromycin,
Clarithromycin, Erythromycin); Estrogenic hormones (17-Alpha-Ethinyl-Estradiol
(EE2), 17-Beta-Estradiol (EE2), Estrone (E1)), Metals (Silver), Diclofenac, PFAS,
Cypermethrin, Groundwater (PFAS, Pharmaceuticals & nrMs), Carbamazepine,
Chlorpyrifos, Bisphenol-A, Hexachlorobenzene, Diuron.
4. Pending SCHEER Opinions:
• For the following dossiers for new candidate substances the SCHEER has not yet
published a preliminary option: Triclosan.
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• For the following dossiers for existing candidate substances for a revised EQS the
SCHEER has not yet published a preliminary option: Mercury, PAHs,
Hexachlorobutadiene, Heptachlor, PBDEs, Dioxins, Tributyltin, Tetrachloromethane.
For substances proposed for deselection: Alachlor, Simazine, Carbon tetrachloride there was
no need for a SCHEER opinion.
A summary of the stakeholder consultations that were carried out (Open Public Consultation
and Expert Survey) is included in Annex 2 Stakeholder Consultation (Synopsis report).
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ANNEX 2: STAKEHOLDER CONSULTATION (SYNOPSIS REPORT)
1. INTRODUCTION
The Impact Assessment accompanying the revision of the lists of pollutants affecting surface
and groundwaters and the corresponding regulatory standards in the Environmental Quality
Standards, Groundwater and WFD was subject to a thorough consultation process that
included a variety of different consultation activities. During the process, the Priority
substances proposed for revision were consulted with stakeholder through the sub-groups of
experts relevant to each substance and overall in the WG Chemicals, WG Groundwater and
Strategic Consultation Groups. Furthermore, an Open Public Consultation has been
conducted, as well as a Targeted Experts Survey and two Stakeholder workshops.
2. CONSULTATION STRATEGY & ACTIVITIES
2.1. Purpose of the online public consultation and targeted consultation
Consultations for the impact assessment of the possible revision of the lists of pollutants
affecting surface and groundwaters and the corresponding regulatory standards in the
Environmental Quality Standards, Groundwater and WFD were conducted with the aim of
gathering the opinion of the general public and experts.
The scope of the consultations primarily concerned three key water policy domains in the
EU: the WFD, the EQSD and the GWD. The WFD aims to ensure that all surface and
groundwater bodies (including transitional and coastal zones) achieve “good status”. For a
water body to be classified in overall good status, both the chemical status and the ecological
or (for a groundwater body) quantitative status must be at least good. Regarding chemical
status (the focus of this consultation)- a process to analyze substances which pose a
significant EU-wide risk to the environment and require further action (Priority Substances)
is enshrined in the WFD. The EQSD establishes standards for these Priority Substances-
ensuring that MS do not surpass thresholds which pose a threat to the environment and
human health. The GWD expands WFD requirements for groundwater quality and protection
through providing a list of relevant pollutants and groundwater quality standards.
Furthermore, the GWD establishes a list of substances which MS should consider when
setting national threshold values for pollutants.
The key objectives of the consultation process were (i) to confirm the scope of the impact
assessment and (ii) to collect information on potential impacts of proposed options and
measures- particularly on potential costs and benefits.
2.2. Consultation strategy
The consultation strategy was developed at the start of the study, in collaboration with the
European Commission. The consultation methods and tools outlined in the strategy have been
followed, as described in more detail in the following sections. Table A2.1 presents the
stakeholder groups mapped to each consultation activity.
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Table A2.1: Stakeholder groups consulted by each consultation approach
Stakeholder type
Consultation approach
Open Public
Consultation
Targeted consultation
survey
Targeted consultation
meetings
EU institutions X X
General Public X
EU MS’ Authorities X X X
Third-country stakeholders X X X
Businesses and trade associations X X X
Non-governmental organisations X X X
International organisations X X X
2.3. Methods of stakeholder engagement
The main consultation activities for the study were the following:
 Feedback received on the Impact Assessment roadmap;
 Open public consultation (OPC);
 Targeted stakeholder engagement through a and expert survey;
 Targeted stakeholder meetings (2 workshops and dedicated interviews).
2.3.1. Impact Assessment Roadmap
The European Commission published the roadmap on ‘Integrated water management –
revised lists of surface and groundwater pollutants’ (98) to offer the opportunity for interested
parties to provide feedback on the scope of the Impact Assessment. The roadmap received 19
pieces of feedback, which are synthesised in section 3.1 of this annex.
2.3.2. Open Public Consultation
The open public consultation included questions tailored to examine three distinctive
components which outlined potential measures to be analysed:
 Protect the aquatic environment and human health from chemical pollution through
achieving good surface water chemical status by controlling emissions of PS and
ceasing/phasing out emissions, discharges and losses of PHS;
 Ensure a high and equal level of protection of groundwater resources including their
connected or dependent ecosystems and their uses;
 To continuously improve knowledge and decision-making on sufficient, correct,
robust and transparent monitoring and reporting information.
The questionnaire was made available in all EU languages and uploaded to the EU Survey
tool. The consultation period started on 26th
July 2021 and ended on 1st
November 2021. The
OPC received a total of 151 responses. An analysis of the feedback received is presented in
section 3.2 of this report. A factual summary was published on the Commission’s Have Your
Say pages (98).
2.3.3. Target stakeholder consultation - survey
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An online survey tailored towards stakeholders with a detailed technical knowledge of
surface water and groundwater substances and current EU legislation was developed. The
survey targeted stakeholder groups including public authorities responsible for implementing
and/or enforcing the Directives, industry and sectoral associations representing companies
concerned, monitoring organisations, environmental and consumer NGOs, universities and
research institutes, and any other organisations interested in responding to the survey. The
survey was made available between 27th
July 2021 and 19th
October 2021.
The survey addressed the three topic areas: surface waters, groundwaters and the
digitalisation, administrative streamlining and better risk management options. The policy
options were based on:
 Addition of substances and/or groups of substances to the list of Priority Substances
(PS) in surface waters (Annex X to the WFD) and the setting of corresponding
Environmental Quality Standards (EQS) in the EQSD;
 Possible amendment of EQS / deselection of existing PS from Annex X to the WFD
and Annex I to the EQSD;
 Designation of some PS as Priority Hazardous Substances (PHS) in Annex X to the
WFD; re-designation of the eight “other pollutants” in Annex I of the EQSD:
conversion to PS, deselection, or retention as ”other pollutants”;
 Addition of substances to the lists of groundwater pollutants (Annexes I and II to the
GWD), with corresponding quality standards in the case of Annex I;
 A set of complementary options aiming to encourage the use of new monitoring
methods and improve current monitoring approaches, improve risk assessment and
the translation into risk management, and enhance data management transparency and
utilization.
The targeted survey received a total of 124 responses.
3. METHODOLOGY AND TOOLS USED TO PROCESS THE DATA
3.1. Open Public Consultation (OPC)
The approach taken included:
 Respondents were asked to respond to stand-alone open-ended questions in
combination with elaborating their answers in open text fields. .
 Based on the responses to questionnaire data graphics were created to summarise and
present the outcomes.
 Finally, any attachments, links, or other materials submitted by stakeholders were
analysed and incorporated.
3.2. Targeted stakeholder consultation - survey
The analysis steps were:
 Questionnaire raw data was imported and cleaned in an Excel template.
 Graphics were created to summarise and present the outcomes.
 Respondents were asked to respond to stand-alone open-ended questions in
combination with elaborating their answers in open text fields.
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 Finally, any attachments, links, or other materials submitted by stakeholders were
analysed and incorporated.
Due to the low number of responses and a general lack in EU wide representation it was not
possible to interpret Member State specific response patterns in the obtained answers. As
such, the analysis focuses on a general overview of respondents’ opinions regarding the
matter, without concluding broadscale national or sector specific positions/opinions.
3.3. Targeted stakeholder consultation - workshop and interviews
Throughout the course of the project, two thematic workshops were held. The workshops
focused on specific core subjects of interest, as highlighted in Table A2.2 below.
Table A2.2: Workshops summary
Workshop Topic
Number of
participants
1: 21st
May, 2021
Primary objective: gather feedback from stakeholders on the policy
options presented. The workshop was split into three distinct
components to align with the types of options considered in the Impact
Assessment, namely: surface waters, groundwaters and digitalisation,
administrative streamlining and better risk management options
247
participants
registered.
2: 18th
March, 2022
Primary objective was to gather feedback on the elaborated set of policy
options and the cost-benefit assessment. The workshop was split into a
groundwater and a surface water session, and a session to discuss the
digitalisation, administrative streamlining and better risk management
options.
250
participants
registered
3.3.1. Workshop 1
The workshop was split into three distinct components to align with the types of options
considered for the impact assessment, namely: surface waters, groundwaters and
digitalisation, administrative streamlining and better risk management options.
For surface water, four topic areas of options formed the basis of the discussion: addition of
candidate substances to the PS list; amendment of EQS for existing PS; designation of the
eight “other pollutants” (included in Annex I of the EQSD) as PS; and deselection of existing
PS which no longer present an EU-wide risk.
For groundwater, three topic areas of options would form the basis of the discussion within
the group: adding PFAS substances to Annex I or II of the GWD; adding pharmaceuticals to
Annex I or II of the GWD; and, adding (potentially) harmful degradation products from
pesticides (nrMs) to Annex I or II of the GWD.
Finally, the digitalisation, administrative streamlining and better risk management option
segment of the workshop focussed on measures identified in the FC of the WFD and
Daughter Directives (10). The digitalisation, administrative streamlining and better risk
management measures session of the workshop focussed on three topics that aimed to
maximize the (cost) effectiveness of procedures, namely: monitoring approaches; risk
assessment and the translation into risk management; and data management.
3.3.2. Workshop 2
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The second workshop took place on 18 March 2022, when the work both on the substance
dossiers and the impact assessment background study had advance considerably. The meeting
was used to present the results of the stakeholder consultation activities so far, in particular
the expert survey and open public consultation. The lionshare of the meeting was however
devoted to the review of the first results of the assessment of environment / social / economic
costs and benefits of the options developed. To this end, a separate session was organized on
surface water options, groundwater options and the range of digitalisation, administrative
streamlining and better risk management options. Participants received a background
document containing the core results of the assessment and an extensive powerpoint
presentation.
4. SUMMARY OF RESULTS OF THE STAKEHOLDER CONSULTATION
The key findings overarching all consultation activities can be summarized as follows:
 Stakeholders noted concerns about contaminants of emerging concern, their impacts
and how these are being addressed. PFAS, microplastics and pharmaceuticals stood
out as concerning substances that require attention in both surface waters and
groundwaters.
 In surface waters, stakeholders did not provide a clear preference across consultation
activities as to whether specific substances should be added as groups (rather than
separate entries), except for PFAS. Overall, stakeholders were uncertain, or had no
opinion on this, given the varying potencies of specific substances within broad
groups, the threat of losing the granularity over specific substance risks, or the
required modes of action on substances.
 For groundwater, results across consultation activities were coherent and indicated
that PFAS should be added to GWD Annex I with a standard 0.10 ug/l. Also,
pharmaceuticals (Carbamaxepine and Sulfamethocazole) should be added as
individual substances Annex I. Consultation activities indicated that stakeholders
agree that metabolites from pesticides should be added, however there were
conflicting observations regarding whether the addition should be to Annex I or
Annex II.
 There was a strong recognition from stakeholders that upstream measures in the form
of the precautionary principle and the application of polluter pays principles are
needed to be considered when addressing risks of contaminants of emerging concern.
 Finally, stakeholders indicated that the revision of pollutants and their EQS’s need to
be coherent with other directives (e.g. DWD, UWWTD and agricultural policies), and
there must be improvements of data collection and transparency of monitored data.
4.1. Impact Assessment Roadmap
Feedback on the Impact Assessment Roadmap was provided by 19 stakeholders, with one
document not included in the analysis due to duplication. 10 responses were from business
associations, whereas 2 were from EU citizens, NGOs, company/business organization and
‘other’. One response was received from a public authority. The key themes in the feedback
included:
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 Stakeholders noted that stronger coherence between the WFD and other EU
legislation is required- in particular with EQSD (n=2, other, public authority), GWD
(n=2, other, public authority), DWD (n=3, Public authority, other, business
association), agricultural policy (n=4, other, business association, company/business
organization, public authority), and REACH (n=1, other);
 Stakeholders also noted the need for stronger upstream prevention and control to force
prevention at source (n=4, NGO, 3 Business associations);
 More focus on substances of emerging concern is needed, in addition regarding
pollutant mixtures (n=3, NGO, Company/business organization, Business
association), in addition to pharmaceuticals, (micro) plastics and PFAS (per and
polyfluoroalkyls) (n=1, other);
 Local conditions should be considered when establishing EQS values- particularly,
Priority Substances should be carefully assessed to see if there is a risk to the EU as a
whole, or only of local relevance (n=5, 4 Business associations, 1 company/business
organisation);
 A number of stakeholders reiterated the need to identifying new Priority Substances
and setting their EQS based on sound science (n=2, Business associations);
 Transparency- 2 stakeholders noted the need for greater transparency relating to
monitoring data (NGO) and dossier outputs (Business association).
5. OPEN PUBLIC CONSULTATION
Here we present the most relevant results from the OPC, identifying the percentage of
responses in relation to each answer.
5.1. Respondents’ profiles
Although in total 151 respondents filled in the questionnaire during the consultation period, it
should be noted that the number of responses to each specific question has varied throughout
the survey. Due to the non-mandatory nature of most questions, it is typical that fewer than
151 responses have been provided to certain questions. From the 151 respondents, Germany
(n=40; 26%), Belgium (n=25; 17%) and France (n=19; 13%) were the primary countries of
origin. In total, from the 151 respondents 144 (95%) were from EU-27 countries. The
remaining 7 were from Morocco (n=1), Norway (n=2), Switzerland (n=1), and the United
Kingdom (n=3). The most common stakeholders to reply (Figure A2.1) were business
associations (n=34; 23%), EU citizens (n=33; 22%) and companies/business organisations
(n=29; 19%). Stakeholders who selected the ‘other’ option (n=16; 11%) and provided a
response included: civil society organization (n=1), MS competent authority (n=3), water
services and utility company (n=1), international organization (n=2).
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Figure A2.1: Stakeholder types
Figure A2.2 provides an overview of the scope of each stakeholder type. As shown, the
majority of business associations, EU citizens, NGOs, Public Authorities,
Academics/research institutions and consumer organisations had a national scope. The
majority of company/business organisations had an international scope.
Figure A2.2: Stakeholder scope
In relation to organisation size, the majority of respondents stated they were from large (i.e.
>250 employees) (n=46; 40%), followed by those from micro (n=30; 26%), small (n=25,
22%) and medium (n=15; 13%) organisations.
Finally, stakeholders indicated their sector of activity (Figure A2.3). The highest number of
responses indicated activity in the water industry and/or management (n=30; 21%), and
biodiversity and/or environment (n=26; 18%). Stakeholders who responded ‘other’ included
mining and extractive industries (n=4), education (n=1), paper industries (n=1).
EN EN
Figure A2.3: Stakeholder sector of activity
5.2. Presence of substances
Stakeholders were asked how concerned they were with the presence of pharmaceuticals,
microplastics, substances from household items, pesticides, industrial chemicals and metals
in both surface and groundwaters. Stakeholders were asked to rate their concerns on a scale
of 1 (not at all) to 5 (very much). For both surface waters and groundwaters, stakeholders
designated a minimum average score of 3.5 (for groundwater microplastics) for the
substances listed, indicating that stakeholders are concerned about the presence of all
substances listed. Figure A2.4 below outlines the average scores for each substance.
Figure A2.4: Responses to the question: “How concerned are you about the presence of
these substances in European surface water (L) and groundwater (R) bodies? Please
rate your concerns on a scale of 1 (not at all) to 5 (very much)”
5.3. Regulatory measures to combat water body pollution
Stakeholders were asked which regulatory measures contributed to WB pollution, and to rate
their contribution on a scale of 1 (not at all) to 5 (very much). The average rating for each of
the measures listed was above 3.0, indicating that stakeholders harbored at least some
concern of their contribution to water pollution. As shown in Figure A2.5 below, “lack of the
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use of ‘precautionary’ and ‘polluter pays’ principles…”, “lack of investment/incentives for
emission reduction” and “lack of incentives to take control measures at the source of
pollution” all received an average score of 3.8, whilst the last measure listed received the
greatest number of ‘5’ responses (n=61, 41%).
5.4. EU actions/strategies to address pollution
Stakeholders were asked to outline which policy actions/ strategies could more effectively
address surface and ground- water pollution. Three options were presented, where
stakeholders could indicate on a scale of 1 (not at all) to 5 (very much) which options should
be improved. As shown in Figure A2.6 below, option c ‘improve collection of data on new
pollutants…’ received the highest average score of 4.2. Stakeholders elaborated in open text,
stating that there is a need for more transparent, publicly accessible data (n=6) to assist in
making science-based decision making.
Figure A2.5:
Responses to the
question:
“Regarding
regulatory
measures and
their
implementation,
in your opinion,
to what extent do
the following
issues contribute
to surface water
and groundwater
pollution? Please
rate each option
below on a scale
of 1 (not at all) to
5 (very much)”
EN EN
Figure A2.6: Responses to the question: What in your opinion should the European
Commission improve to ensure its policy actions / strategies address more effectively
surface and groundwater pollution? Please rate each option below on a scale of 1 (not at
all) to 5 (very much)
Finally, according to the OPC respondents, the following issues were not included in the
OPC-questionnaire, but should be addressed by the European Commission:
 Need to develop a shared list of priority and watch list substances across policies: water
policy (groundwater, surface water, marine MFSD), CAP, sewage sludge, Fertilising
Products (FPR), REACH, IED.
 Overall, a more strict and integrated system to reduce emissions of harmful substances
should be implemented, by connecting REACH, IED, UWWTD and WFD, via
restrictions of emissions & substances of very high concern (SVHC's).
 Water protection must be pursued according to the precautionary and polluter pays
principles. End-of-pipe solutions are neither a holistic nor a sustainable solution;
extended producer responsibility (EPR) must be applied to cover costs.
 Addition of so-called ‘non-relevant’ metabolites (nrMs) of pesticides to Annex I of the
GWD, together with relevant metabolites. The pesticides total value should include
nrMs.
 Data collection for additional pollutants should be driven at the EU level.
 Need to enhance the protection of groundwater as an ecosystem (including better
protection of organisms responsible for self-purification of groundwater) in line with
recital 20 of GWD, and inclusion of non-material indicators like biology and
temperature.
6. TARGETED STAKEHOLDER CONSULTATION - SURVEY
6.1. Respondents profiles
All 124 respondents provided replies to the ‘About you’ section of the survey. As seen in the
figure below, the highest number of respondents came from Germany (n=31). This was
followed by Belgium (n=22), Czech Republic (n=9), and France (n=8). Thereafter, Member
State representation was generally lower. Figure A2.7 shows all EU-27 represented countries.
There were also several non-EU respondents, including from the United States (n=1),
Norway (n=1), Switzerland (n=4) and Turkey (n=1).
As a follow-up, respondents indicated the country where their organisation is located. The
trends seen in Figure A2.8 do not significantly deviate from Figure A2.8: the most significant
number of respondents identified their organisations based in Germany (n=33), followed
again by Belgium (n=25), Czech Republic (n=8), and France (n=8). Respondents could only
choose EU27 countries as their organisation base or were given the opportunity to write the
answer in. Three respondents noted that their organisation was based in Switzerland, and one
in Turkey.
EN EN
FigureA2.7: Responses to: Country of Origin
Figure A2.8: Responses to: Which country are you or your organisation based?
When asked about the scope which the respondents organizations covered, the majority
indicated working at a national scale (n=64). A similar number of respondents indicated
working at regional (n=26) or EU wide level (n=20), and a significant number (n=10) also
indicated working for organisations with an international scope. Five respondents indicated
‘Other’ scope, of which three expressed that they worked at regional scales (naming the
region of their Member State).
Responses did not indicate a wide distribution of stakeholder groups. Most of the participants
represented MS competent authorities (n=46), followed by business associations (n=31) and
academic/research institutions (n=13) (Figure A2.9). A number of respondents identified
themselves as ‘Other’ (n=11). Those that provided details, identified themselves as
‘Candidate country competent authority’ (n=1), ‘Non-profit association of expert
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organisations’ (n=1), ‘Competent authority for water’ (n=1) and ‘Groundwater Expert
Consultant’ (n=1).
Figure A2.9: Responses to: I am giving my contribution as…
Finally, respondents were asked to indicate the sector they represent (Figure A2.10). Here the
distribution of representation was wider, with biodiversity and/or environment and the water
industry sectors having the highest representation (n=34 and n=33 respectively).
Interestingly, a number of respondents (n=20) indicated ‘Other’ sectors. Two respondents
indicated to be working for national water authorities, three indicated working in
groundwater monitoring and protection, three indicated working in water and environmental
monitoring of pollutants and hazardous substances, and one indicated working in petroleum
refineries. The sectors of energy, investment and finance, pharmaceuticals, plastics, textiles
and urban planning had no respondents.
Figure A2.10: Responses to: Please indicate the sector(s) you are active in:
Respondents had the opportunity to respond to surface water, groundwater and
complementary questionnaires. They could choose to answer as many as they felt familiar
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with. A total of 101 indicated an interest in answering surface water questions, with 65 and
78 participants selecting groundwater and complementary questionnaires, respectively. Note
that this does not represent the total number of responses received per question, as
respondents were not obliged to answer any questions.
6.2. Surface water
6.2.1. Addition of candidate Priority Substances
For all of the candidate substances listed, stakeholders indicated a preference to including
them as Priority Substances (Figure A2.11). Regarding whether specific substances should be
added as groups (rather than separate entries), the responses did not present such a clear
preference (Figure A2.12). Macrolide antibiotics (n=19; 31%) and PFAS (n=34; 52%)
received a greater number of ‘yes’ responses than ‘no’- indicating a preference to add
substances as a group with a set of joint EQS values. Conversely, Neonicotinoids (n=24;
38%) and Pyrethroids (n=23; 36%) received a greater proportion of ‘no’, indicating a
preference not to group such substances.
Figure A2.11: Responses to: Should the substances in the table below be added as
Priority Substance?
EN EN
Figure A2.12: Responses to: Please indicate whether you think the substances should be
added as groups.
When asked to estimate the significance of economic, health, social and environmental
benefits / impacts resulting from the inclusion of new candidate PS, the respondents generally
found all impacts to be positive (i.e. rated at minor, moderate or major benefit). Benefits from
improved surface water quality, lower risk of damage to natural resources and benefits from
improved environment and human health protection were valued most (Figure A2.13). The
impacts of new candidate substances on the quality of process water for agriculture and
industry received the greatest number of ‘no benefit’ responses (n=8; 16%). Impacts
regarding employment opportunities were identified as being largely unknown, indicated by
the large share of ‘I do not know/no opinion’ responses (n=31; 57%).
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Figure A2.13: Responses to: Can you please provide your estimate of significance of
economic, (human) health and social, as well as environmental benefits/ impacts
resulting from the inclusion of new candidate priority substances?
For the majority of benefits listed, respondents were unable to provide cumulative estimates
of their potential economic, health, social or environmental impacts. Lower production and
maintenance costs through the availability of cleaner raw water received the fewest number
of ‘I do not know/no opinion’ responses, where 7% (n=3) estimated costs above €10,000,000
and 2% (n=1) at €501,000-€1,000,000.
6.2.2. Change of status of the “eight other pollutants”
DDT received the greatest number of ‘fully added as a PS’ responses (n=15; 23%), followed
by Trichloroethylene (n=6; 10%) and Tetrachloroethylene (n=5; 8%). Isodrin, Endrin,
Dieldrin and Carbon tetrachloride all received 38% of responses for them to be removed from
EQSD entirely, whilst DDT received the greatest number of responses to retain it as a ‘other
pollutant’ (n=18; 28%).
6.2.3. Revision of existing EQS
Stakeholders were asked whether they believed the Annual Average (AA), Maximum
Allowable Concentration (MAC), and/or biota EQS values are too high, too low, or assigned
correctly to a selection of Priority Substances. Here, a summary of the responses (excluding
‘I do not know/ no opinion’ answers) is presented.
Regarding AA concentrations, Chlorpyrifos (n=11; 20%) and Diuron (n= 6; 11%) received
the greatest number of ‘too high’ responses, whilst Nickel (n=14, 25%) received the greatest
number of ‘correct’ responses. PAHs (based on Benzo[a]pyrene) (n=14; 30%) and
Fluoranthene (n=12; 27%) received the greatest number of ‘too low’ responses.
Regarding MAC, the majority of responses indicated that Chlorpyrifos (n=15; 27%) and
Diuron (n=14; 25%) values were ‘too high’, EQS values for MAC are ‘correct’ for Nickel
(n=13; 25%) and ‘too low’ for Heptachlor and Heptachlor epoxide (n=6; 12%).
Finally, biota concentrations were regarded as ‘too high’ for PAHs (n=6; 12%), ‘correct’ for
Hexachlorobenzene (n=5; 10%), Hexachlorobutadiene (n=4; 9%), Mercury and its
compounds (n=5; 10%), and ‘too low’ Brominated diphenyl ethers (n=10; 20%) by the
majority of respondents.
6.2.4. Deselection of existing Priority Substances
Stakeholders were asked to comment on which existing PS no longer pose an EU-wide risk.
Except for Hexachlorobenzene, all the substances identified for deselection during the
technical work80
received a greater number of ‘yes’ (deselect) than ‘no’ (keep as PS)
responses. Alachlor received the greatest number of ‘yes’ responses (n=34; 54%), followed
by Chlorfenvinphos (n=32; 53%).
80
Substances targeted for deselection at the time: Alachlor, Chlorfenvinphos, Simazine, Benzene, Hexachlorobenzene and
Hexachlorobutadiene
EN EN
For all substances listed, the majority of responses indicated that respondents ‘don’t
know/have no opinion’ regarding the economic benefits of deselection. All substances
received a greater proportion of ‘yes’ responses than ‘no’, with Alachlor (n=25; 45%),
Chlorfenvinphos (n=24; 44%) and Simazine (n=22; 41%) receiving the greatest number of
responses indicating economic benefits of deselection.
6.3. Groundwater
6.3.1. Additions to GWD Annexes
Stakeholders were asked to select which option for adding PFAS to the GWD annexes would
be preferred. Option A (Add 10 PFAS with a ‘group of 10’ (i.e. ‘Sum of PFAS’) standard of
0.10 µg/l to Annex I of the GWD (based on DWD recast)) received the greatest proportion of
responses (n=17; 46%), followed by Option F (None of the above / Business as usual (BAU))
(n=9; 24%). Option B (Add 10 PFAS with a ‘group of 10’ standard (i.e. ‘Sum of PFAS’) to
Annex I of the GWD but with a different GW QS to Option A) garnered the lowest
preference by stakeholders (n=1; 3%).
In relation to adding Carbamazepine and Sulfamethoxazole to the GWD annexes, Option A
(Add the two named pharmaceuticals to Annex I with the following indicative GWQS:
Carbamazepine 0.5 µg/l; Sulfamethoxazole 0.1 µg/l) received the greatest number of
responses (n=10; 30%), followed by Option E (n=9; 27%). Option D (Add pharmaceuticals
as a group to Annex I, but with a different value for the GWQS to Option C) received the
lowest number of responses (n=0).
Finally, responses for adding harmful breakdown products (metabolites) from pesticides
(nrMs) to the GWD Annexes indicated that Option A (Add the 16 harmful breakdown
products (metabolites) from pesticides (nrMs) to Annex I with individual GWQS of 1 µg/l for
each substance) (n=13; 37%) was the preferred option.
6.3.2. Benefits/impacts
Stakeholders were asked to identify which economic, (human) health and social, and
environmental impacts related to groundwaters provided the most significant benefits. The
results are shown in Figure A2.14. Stakeholders identified ‘benefits from improved water
quality’ and ‘benefits from improved environment and human health protection’ as providing
the greatest positive impacts (n=12; 35%), followed by ‘lower production and maintenance
costs through availability of cleaner raw water, reducing pre-treatment needs / avoided costs
of drinking water (pre)treatment as a result of improved quality of groundwaters used for
drinking water abstraction’ (n=11; 32%). Very few monetised estimates could be provided by
respondents. Those which were provided, estimated high costs above €10,000,000 related to
lower risk of damage to natural resources and lower production and maintenance costs
through availability of cleaner raw water, receiving 4% (n=1) and 12% (n=3) of total
responses respectively.
EN EN
Figure A2.14: Responses to: Can you please provide your estimate of significance of
economic, (human) health and social, as well as environmental benefits/ impacts?
6.4. Monitoring, reporting and administrative streamlining options
6.4.1. Guidance documents
Respondents were asked to rank on a scale of 1 - not at all - to 5 - extensively used to inform
decisions - which past guidance documents (of relevance to the legislation under the scope of
the Impact Assessment) have been used in their MS. Guidance related to ‘risk assessment’
were deemed the most extensively used (average score of 4.6), closely followed by ‘guidance
on reporting’, ‘guidelines on water quality analytical methods’ (4.3) and ‘Guidelines on
Environmental Quality Standards’ (4.2). ‘Guidelines for public participation and
transparency’ received the lowest average score of 3.2, indicating that they are not
extensively used to inform decisions.
Stakeholders were also asked which additional guidance documents would be deemed useful
(Figure A2.15). ‘Guidelines on the characterization on groups/mixtures of pollutants and their
possible toxicity’ and ‘Guidelines on applying innovative methods in monitoring procedures’
received the highest average scores and highest number of ‘very useful’ responses (n=25;
53% and n=26; 55% respectively).
EN EN
Figure A2.15: Responses to: In your opinion, how useful would the following additional
guidance documents be?
6.4.2. Surface Water Watch List
Respondents voted the increase in monitoring frequency of substances in the Surface Water
Watch List as the most effective method for improving the risk response and management
(average score of 3.2). However, the polarity of the responses received for this measure was
also significant. In total, 26% (n=12) voted the measure as non-effective (rating 1) and
another 28% (n=13) rated it as highly effective (rating 5). Respondents that voted the
measures as highly effective represented mostly MS authorities (n=8) and academic research
(n=2), while those that related the measures as non-effective represented a mix of business
associations (n=3), companies (n=2) and MS competent authorities (n=3). A similar polarity
exists for the measure of increasing the frequency in which WL substances are incorporated
as Priority Substances (30% rated 1, 30% rated 5). The main consensus is evident for the
possible increase in reporting frequency obligations, for which half the respondents very
clearly indicated that they did not see such a measure improving the risk response.
6.4.3. Harmonisation of RBSP thresholds
All measures presented to assist in the harmonization of the RBSP thresholds had very
similar rating scores around 3.2. The highest rated (average 3.3) was to provide a
recommended range for thresholds for reference RBSPs under the EQSD, while the lowest
rated (3.0) was the guidance on monitoring needs for RBSPs. Generally, all measures had
very similar distributions in response ratings, indicating that there may be a combination of
approaches that may assist in achieving the desired harmonization rather than just one
specific measure.
6.4.4. Data management
Stakeholders were asked to rate (on a scale of 1 (not at all) to 5 (very much)) measures aimed
at achieving data management, transparency and utilization were important from their
EN EN
perspective. ‘Standardise data collection and reporting methods to improve comparability of
data’ was noted as the measure with the highest average rating of 4.1, closely followed by
‘Optimise the coordination of data-sharing practices with other policy sectors’ (average rating
of 4.0).
6.5. Targeted stakeholder consultation - workshops
Here we present the most relevant results from the two targeted workshops. The primary
objective of the workshops was to inform stakeholders of a set of proposed policy options
and gather their inputs relating to these options. The first sessions of both workshops split
participants based on their expertise relating to surface waters and groundwaters. The second
session of the day reconvened all participants to discuss measures relating to digitalisation,
administrative streamlining and better risk management options. The key outcomes of these
distinctive sessions are presented in turn below.
6.5.1. Surface water session
The first topic area theme ascertained which candidate substances stakeholders would like to
see added to the PS list as separate entries, or added as groups of substances. Estrogenic
hormones (n=56; 62%), PFAS (n=61; 73%) and neonicotinoids (n=40; 52%) all received a
majority of votes by stakeholders indicating a preference to add as groups. The majority of
participants noted that antibiotics should be added as individual substances (n=38; 46%). The
second topic area sought stakeholder views on amendments to EQS for existing PS and other
pollutants. Stakeholders noted that EQS for PBDEs (n=27; 41%), mercury (n=22; 33%) and
heptachlor (n=19; 29%) in particular, should be reviewed. The final topic area looked at the
potential of deselecting existing PS. Stakeholders here showed a preference to deselecting all
the listed substances (Alachlor, Chlorfenvinphos, Simazine, Benzene, Hexachlorobenzene
and Hexachlorobutadiene) (n=28; 55%).
6.5.2. Groundwater session
Topic area one of the session discussed adding PFAS substances to Annex I or II of the
GWD. Stakeholders showed preference to adding PFAS to Annex II (to allow MS to deal
with local conditions) (n=22; 42%). Participants notes that if PFAS quality standards were
listed under Annex I, standards should be established at 0.10 µg/l (n=30; 52%). The second
topic area asked stakeholders for their views on adding pharmaceuticals to Annex I or II of
the GWD- with 67% (n=39) of participants showing preference to add these as individual
substances. Finally, topic area three focused on the addition of pollutants consisting of
degradation products from pesticides (nrMs) to Annex I or II of the GWD. The majority of
participants stated a preference to add nRMs to Annex II (n=29; 56%).
In targeted stakeholder feedback industry stakeholders indicated that a GWQS for the 16
nrMs of 9 µg/l could be calculated using a Threshold of Toxicological Concern approach
(99), whereas other stakeholders noted that the EFSA methodology explicitly states that this
approach should not be used for substances for which EU food/feed legislation requires the
submission of toxicity data or when sufficient data are available for a risk assessment. The
position from the non-industry stakeholder was that Europe wide legislation is needed to
ensure that the levels of nrMs reduced in groundwater and that more sensitive biota in
EN EN
groundwater ecosystems were protected. MS and representatives from the drinking water
industry states that there is widespread detection of nrMs in groundwater and that this
situation needs to be addressed, while noting that the GWD requires that inputs of hazardous
substances need to be limited in their entry into groundwater, and nrMs fall within this group.
Consequently, further regulation of the entry of nrMs to groundwater is needed to deliver on
this requirement.
6.5.3. Session on monitoring, reporting and administrative streamlining options
This session centred on three topics that aimed to maximize the (cost) effectiveness of
procedures, namely: monitoring approaches; risk assessment and the translation into risk
management; and data management. Regarding monitoring approaches, stakeholders
provided contrasting views on guidelines to alternative monitoring methods - noting that
innovative approaches (such as effect-based monitoring) could improve freshwater quality
yet may result in a greater monitoring burden to actors. In the topic area two discussions,
stakeholders noted that deriving harmonized EQS values for RBSPs were challenging due to
changes in values from knowledge development and a lack of current harmonised approaches
between MS. Finally, on data management stakeholders noted that guidelines to standardise
data collection and reporting formats could be beneficial.
116
ANNEX 3: WHO IS AFFECTED AND HOW? PRACTICAL IMPLICATIONS OF THE INITIATIVE
1. SUMMARY OF COSTS AND BENEFITS
I. Overview of Benefits (total for all provisions) – Preferred Option
Description Amount Comments
Direct benefits
Improved
surface water
quality
Additions: total benefits not quantified for EU27, but:
- Avoided/reduced environmental impacts and potential toxic effects on aquatic species. E.g.
Carbamazepine (impacts on fertility and reproduction);ibuprofen potential toxic effects for some
aquatic species including fertility effects ; Nicosulfuron has aquatic toxicity and concerns over
carcinogenicity as a secondary poisoning. Diclofenac potential toxic effects on avian populations
via surface water species. Estrone E1, 17- Beta estradiol (E2), Ethinyl estradiol (EE2) are
associated with chronic ecosystem level impacts from exposure to hormones and EDC. PFAS has a
widespread and very long-lasting environmental effects while Bisphenol A as an endocrine causes
disrupting chemical for aquatic organisms. Triclosan is toxic for aquatic organisms particularly
larvae and fish eggs. Acetamiprid, Clothianidin, Imidacloprid, Thiacloprid, Thiamethoxam
Bifenthrin, Deltamethrin Esfenvalerate and Permethrin are associated with toxic aquatic effects
against invertebrates, arthropods, and crustaceans with wider environmental concerns for terrestrial
pollinators. Glyphosate is associated with harm to aquatic environments given the very high usage
rates and risks for loss to water.
- Avoided/reduced human health impacts via reduced exposure through drinking water, from
specific exposure to Neonicotinoids, EDC and (potential) carcinogenic effects. E.g. Annual costs
related to endocrine disruptors exposure were estimated to be €163 billion (above €22 billion with
a 95% probability and above €196 billion with a 25% probability) (84).. Protection against AMR
has clear societal benefits and avoided costs to healthcare from protection against the development
of AMR : estimated AMR costs in EU €1.5 billion per year in healthcare costs and productivity
losses81
(64) (101) (102).
- The long term benefit of adding antimicrobials and silver onto the lists is limiting antimicrobial
resistance, allowing current and future antimicrobials to retain their positive effect on patients.
- Assuming that between 1-5% UWWTPs would have to deploy reverse osmosis, costs for EU
taxpayers would range between €2,184,600 and €109,230,000.
- Benefits /avoided costs of reducing AMR from antibiotics in relation to infections from multi-drug
resistant bacteria are estimated to add up to a total of €41 billion (2014 data).
- The EU benefits / avoided costs of removing silver to reduce the risk for AMR and other risks are
estimated to range between €20 to €41 billion (2014 data).
- Avoided/reduced impacts on pollinators and agriculture. E.g. across Europe, crop pollination by
insects accounted for approximately €14.6 billion annually (103).
- Avoided costs of water treatment for drinking water, agriculture and industry E.g. in 2015,
approximately €0.5 billion was spent annually to remove pesticides in wastewater treatment plants
(WWTP) in Europe (104).
- Economic benefits for aquaculture from improved food quality
- Innovation for development of alternative chemicals and technologies (e.g. Bisphenol A)
Amendments: total benefits not quantified for EU27, but:
- Updated EQS based on new science and re-appraisal of risk would provide more appropriate
protections (all substances)
- Improved protections for human health particularly in relation of POP substances, issues around
bioaccumulation (dioxins and furans, chlorpyrifos, hexachlorobutadiene, HBCDD), EDC (diuron,
chlorpyrifos), exposure to chronic pollutants (mercury, nickel). E.g. chlorpyrifos and PBDE as
endocrine disruptors were associated with attention deficit hyperactivity disorder (ADHD) and
with other cognitive deficiencies. The productivity loss caused by these disorders is estimated to be
€124 billion annually in EU. Additionally, prenatal exposure to chlorpyrifos across the EU would
cost an additional €21.4 billion in social costs. The neurotoxicity of chlorpyrifos is estimated to be
70 to 100% according to the epidemiological and toxicological evidence, which corresponds to a
social cost of €46.8 billion and €195 billion annually in the EU (100). It was also estimated that the
cognitive deficits caused by chlorpyrifos and methylmercury would cost the EU €177 billion and
€9.89 billion, respectively
- Reduced environmental concentrations, improved environmental protections for ecosystem
services (cypermethrin, nonylphenols, PAHs)
- Avoided health costs for aquaculture (cypermethrin, tributyltin, mercury, nickel)
- Cost savings and efficiencies: the proposed EQS is less stringent for heptachlor/heptachlor oxide,
hexachlorobenzene, PBDEs and fluoranthene, meaning resources can be reallocated and costs
saved from measures no longer needed.
81
Based on an exchange rate of 1 EUR = 1.09 USD
117
I. Overview of Benefits (total for all provisions) – Preferred Option
Description Amount Comments
Other eight pollutants: total benefits not quantified for EU27, but:
- Three of the four cyclodiene pesticides (aldrin, dieldrin, endrin;,isodrin is an isomer of aldrin) are
listed as POPs under the Stockholm Convention and have been banned in the EU for many years.
The rate of EQS exceedance suggests environmental risk is low, and benefits of continued
monitoring may be limited. However, monitoring data are needed anyway under the POPs
Regulation and could inform decontamination measures.
- DDT is also a recognised POP. Use in EU has long since ceased and rate of EQS exceedance is
extremely low. Maintaining the monitoring time-series would support the tracking of DDT in the
environment, and link with monitoring of, e.g. imported foods.
While tetrachloroethylene and trichloroethylene are still in use, and health concerns well founded, the
monitoring data shows exceedances in only 6 and 3 surface water bodies out of 97,000 suggesting a very low
environmental risk at present. However, these substances are still of concern in groundwater and drinking
water, and in marine waters.
Deselection: total benefits not quantified for EU27, but
 Deselection of substances that no longer represent an EU-wide risk could free up resources for
reallocation by Competent Authorities to the monitoring and/or management of emerging
pollutants, including watch-list substances and the new priority substances.
 The pesticides alachlor, simazine and chlorfenvinphos are clearly hazardous but no longer
approved for use; the risk of exposure is very low and would be expected to remain so.
Improved
groundwater
quality
PFAS: total benefits not quantified for EU27, but
 Lower risk of (irreversible) damage to natural resources such as groundwater and connected
surface waters and ecosystems (i.e. reduced impact on sensitive water bodies such as wetlands and
rivers, and fish);
 Avoided illness / death through low level exposure through drinking water / food to PFAS:
estimated the annual health expenditure due to kidney cancer €12.7 to €41.4 million in the EEA
countries; hypertension in the EEA countries estimated at €10.7 to 35 billion per year (based on
207.8 million population);
 Improved availability of clean raw groundwater for abstraction and lower production and
maintenance costs (for drinking water, irrigation, livestock watering)
 Benefits to sectors requiring a high quality of groundwater such as bottled water and other water
uses (angling, swimming, etc).
 Avoided costs of (pre)treatment as a result of improved quality for potable water and process water
for drinking water supply, agriculture and industry (GAC treatment costs € millions per site) in the
case of source control and pathway disruption measures
 Reduced energy costs and related process costs for wastewater treatment to tackle PFAS (in the
case of source control and pathway disruption measures)
 Increased knowledge and understanding of the risks of PFAS posed to the water environment.
 Consistent approach to data collection at EU level and improved knowledge (more data collected)
on the impact of
PFAS.
Pharmaceuticals: total benefits not quantified for EU27, but
 Reduced pollution of groundwater and connected aquatic ecosystems with reduced impact on
sensitive habitats.
 Increased reuse and recovery of pharmaceutical-free materials (e.g. use of sludge, treated
wastewater).
 Reduction in AMR likely to be small (mainly covered by baseline measures) - Reduction in AMR
through control of anti-biotic use (costs avoided of €1.5 billion to the EU)
 The long term benefit of adding antimicrobials onto the lists is limiting antimicrobial resistance,
allowing current and future antimicrobilal to retain their positive effect on patients.
 Small increase in well-being from reduced risk of chronic ingestion in drinking water / improved
ecosystem health.
 Positive impact on shellfish and fisheries where groundwater inputs to rivers and estuaries is
significant
 Reduced energy, carbon emissions and chemicals use associated with reduced treatment of
drinking water (in the case of source control and pathway disruption measures)
 Improved efficiency - specific risks to groundwater are investigated and dealt with locally rather
than through EU wide schemes which may be too high level to be effective
 Consistent approach to data collection at EU level and improved knowledge (more data collected)
on the impact of these two pharmaceuticals.
nrMs: total benefits not quantified for EU27, but
 Reduced risk of damage to natural resources such as groundwater and connected ecosystems
 Benefits to sectors requiring a high quality of groundwater such as bottled water or aquaculture
and other water uses (angling, swimming, etc.).
 Increased availability of clean raw groundwater for abstraction (for drinking water, irrigation,
118
I. Overview of Benefits (total for all provisions) – Preferred Option
Description Amount Comments
livestock watering)
 Avoided costs of (pre)treatment as a result of improved quality for potable water and process water
for agriculture and industry
 Increased ecosystems services from groundwater biota not impacted by nrMs and cocktail effects
 Climate change impacts through reduced energy use (e.g. due to changes to wastewater and
drinking water treatment processes) (in the case of source control and pathway disruption
measures).
 Increased knowledge and understanding of the risks of metabolites of pesticides posed to the water
environment.
 plus reduced impacts on groundwater biota
 Consistent approach to data collection at EU level and improved knowledge (more data collected)
on nrMs in groundwater leading to better understanding of risks.
 Improved knowledge and better data for use during pesticide parent authorisation process.
 The main costs in relation to the reduction of concentration levels of pesticides in surface- and
groundwater are expected to be covered by the implementation of the revised legislation on the
sustainable use of pesticides directive (SUPD). According to that evaluation, costs related to
training, inspections, Integrated Pest Management (IPM) will mainly fall on the professional users
of pesticides, in particular farmers, who on the other hand have little or no direct economic benefit
from implementing SUPD provisions, except for the reduced expenses on (expensive pesticides).
The SUPD evaluation also showed that since 2009 there have been no remarkable drops in
pesticide sales, or losses in terms of forgone sales.
 In the Netherlands, the costs associated with the treatment of water from pesticides and their
transformation products corresponds to approximately 18 million EUR per year, which
corresponds to around 1 million per million inhabitants. Extrapolated to the EU this corresponds to
510 million EUR per year in treatment costs. If, in line with the targets of the F2F strategy,
pesticide use is decreased by 50%, treatment costs would be expected to decrease correspondingly
and by 205 million/year. In Wallonia, Belgium, the additional costs to consumers passed on by
water treatment utilities due to pesticide pollution are currently around EUR 0.2 to 0.4 per m³,
primarily caused by the costs for activated carbon filters. These costs to consumers would likely
also decrease by 50% : On average, 144 litres of water per person per day is supplied to
households in Europe , corresponding to 52m3 per year. Costs savings for consumers would thus
be around EUR 5-10 per person/year.
 Economic value of pollinating insects to crop production in the EU is at least €3.7 billion per year.
It is clear that pesticides (and in particular the neonicotinoids) are very toxic and persistent and
contribute to the loss of honeybees.
 Bumblebees that were fed the neonicotinoids at the same level found in treated rape plants and
found that these colonies were about 10% smaller than those not exposed to the insecticide
 Assuming that between 10% or 50% of the economic losses from pollinator decline are attributed
to the toxicity of pesticides, this results in mean annual benefits from €370 million to 1.85 billion.
Indirect benefits
Monitoring,
reporting and
administrative
streamlining
options
Option 1 (Guidelines on the monitoring of groups/mixtures of pollutants): not quantified for EU27, but
the guidance document itself has limited impact, however a provision for monitoring estrogens with EBM
could have substantial positive impacts.
Option 2b (An obligatory Groundwater Watch List): not quantified for EU27, but positive impacts due to
better decision-making processes regarding substances posing risks and better comparability of data.
Option 3d (Repository of standards of EQSs for the RBSPs): not quantified for EU27, but positive impact
through harmonization of EU-wide standards allowing more effective measures. Positive impacts for social
well-being and health, providing equal standard of water resource across EU.
Option 4a (Flexible adaptation to scientific progress and knowledge by updating the lists of pollutants
and their EQS (under both EQSD and GWD) by delegated acts): not quantified for EU27, but positive
impact due to quicker actions to address new substances. Positive impacts as innovation and research will
lead to possible employment opportunities.
Administrative cost savings related to the ‘one in, one out’ approach*
(direct/indirect) Deselection of existing PS: €3.8 million - €11.7 million per year (monitoring of 5 substances).
119
II. Overview of costs – Preferred option
Cost type
Citizens /
Consumers
Businesses Administrations
One-off Recurrent One-off Recurrent One-off Recurrent
Surfac
e
water
Direct
adjustm
ent
costs
Not
applicabl
e - €0
Not
applicabl
e - €0
Additions: Not quantified for EU27, but:
Significant costs to ensure compliance with proposed EQS for
Ethinyl estradiol (EE2), Ibuprofen, Clothianidin, Imidacloprid,
Thiamethoxam, Bifenthrin, Deltamethrin, Esfenvalerate,
Permethrin, Glyphosate, Triclosan, PFAS and Bisphenol A
implementing a range of source control, pathway disruption,
targeted end of pipe treatment measures. E.g. the cost of a take-
back scheme for unused pharmaceuticals in France is €10
million. The 2022 Annex XV restriction report for the proposed
restriction of PFASs in firefighting foams estimates that the ban
is estimated to cost society €6.8 billion over a 30-year period or
€390 million per year (26). Costs of pathway disruption
measures (e.g. buffer strips) is €472 million per year for
pharmaceuticals; for pesticides these range from €162 million
for clothianidin and imidacloprid to €285 million for glyphosate.
Wastewater treatment range is €10- €32 per population
equivalent, per annum (technology dependent).
Moderate/Small costs to ensure compliance for Estrone E1, 17-
Beta estradiol (E2), Diclofenac, Carbamazepine, Azithromycin,
Clarithromycin, Erythromycin, Acetamiprid, Thiacloprid,
Nicosulfuron due to small distance to target, availability of
source control and pathway disruption measures and/or positive
impact of forthcoming revision of the UWWTD on quaternary
end of pipe treatment. E.g. costs of pathway disruption measures
(e.g. buffer strips) for pesticides range from €1.6 million for
acetamiprid to €12.8 million for nicosulfuron. Wastewater
treatment cost range is €10- €20 per population equivalent, per
annum (technology dependent).
Amendments:
Not quantified for EU27, but:
Significant costs to ensure compliance for Cypermethrin,
Chlorpyrifos, Diuron, PAHs, Mercury, Nickel implementing a
range of source control, pathway disruption, targeted end of pipe
treatment measures. E.g. the restriction proposal which would
ensure that granules or mulches (in particular from end-of-life
tyres) are not placed on the market for use or used as infill
material in synthetic turf pitches or similar applications if they
contain more than 20 mg/kg in total of the eight indicator-PAHs
would cost €45m (105) over a 10-year period. Costs of
additional controls and treatment for farmed animal use of
cypermethrin are €27.6 m82
. Wastewater treatment (Mercury,
Nickel, PAH, Cypermethrin) - €1.17- €26.2 per population
equivalent, per annum (technology dependent).
Mine drainage (Mercury) - €100,000 -€10,000,000 per plant and
€0.4 per dm3
operating costs.
Moderate/Small costs to ensure compliance for Dioxins and
furans, Hexachlorobutadiene, Nonyl Phenol, Tributyltin due to
small distance to target and/or limited scope for additional
measures (likely to be natural attenuation and baseline end of
pipe treatment (under the revised UWWTD)). E.g. the costs of
restricting nonylphenol (NP) and its ethoxylates (NPE) in
Not
quantifie
d
Not
quantified
82
Cost calculation is based on the average cost of dip pens and containment areas to allow drying €1,120 as a one-off cost multiplied by the
number of sheep farms in Eurostat (24,600) rounded to three significant figures.
120
II. Overview of costs – Preferred option
Cost type
Citizens /
Consumers
Businesses Administrations
One-off Recurrent One-off Recurrent One-off Recurrent
textiles was estimated to cost the EU €3.2m per annum for a
reduction of 15 tonnes of NP/NPE released to surface water
(105).
No additional costs for Dicofol, Heptachlor/ Heptachlor oxide,
Hexachlorobenzene, Fluoranthene, PBDEs.
Other 8 pollutants: Not quantified, but minor additional
compliance costs (extremely low current exceedances).
Surfac
e
water
Direct
adminis
trative
costs
Not
applicabl
e - €0
Not
applicabl
e - €0
Not quantified Not quantified Not
quantified
Not quantified
Surfac
e
water
Direct
regulato
ry fees
and
charges
Not
applicabl
e - €0
Not
applicabl
e - €0
Not quantified Not quantified Not
applicabl
e - €0
Not applicable
- €0
Surfac
e
water
Direct
enforce
ment
costs
Not
applicabl
e - €0
Not
applicabl
e - €0
Not quantified Not quantified Not
quantified
Additions:
Not quantified
for EU27 but
additional
analytical costs
range from
€11-100 per
sample for all
substances
except for
PFAS ( €250).
Amendments:
Not quantified,
but
amendments
for
Chlorpyrifos
and Dioxins
and furans
could lead to
additional
analytical costs
Other 8
pollutants: Not
quantified, but
cyclodiene
pesticides,
DDT,
tetrachloroethy
lene and
trichloroethyle
ne have an
EQS that
warrants
monitoring and
analysis by
MS.
121
II. Overview of costs – Preferred option
Cost type
Citizens /
Consumers
Businesses Administrations
One-off Recurrent One-off Recurrent One-off Recurrent
Surfac
e
water
Indirect
costs
Additions:
Not quantified but
additions of new
substances could lead
to societal impacts
from less use
(contraceptive pill,
HRT, hormone
treatments)
- Similar /restricted
use of Diclofenac,
Carbamazepine,
Ibuprofen and
increased costs for
other types of
medicine (including
prescription only
medications)
- Possible food
security issues if loss
of use without
chemical/non-
chemical alternatives
in place (Bifenthrin,
Deltamethrin
Esfenvalerate,
Permethrin)
- Societal impacts for
domestic pet owners
if use of
Imidalcoprid is
restricted
Not quantified Not quantified Not
applicabl
e - €0
Not applicable
- €0
Groun
dwater
Direct
adjustm
ent
costs
Not
applicabl
e - €0
Not
applicabl
e - €0
PFAS: Not quantified for EU27, but:
- Restriction of use: €6.8 billion over a 30-year period or €390
million per year (26) per substitute use.
- Management of contaminated biosolids (water industry): €201
million/yr (landfilling) to €503-€755 million/yr high temperature
incineration of 10% of all biosolids
- Paper manufacturing: €77 million/yr (landfilling) to €192 -€288
million/yr high temperature incineration of paper mill wastes
Pharmaceuticals: Not quantified for EU27, but:
- Returns program / Green Pharmacy initiatives in a small number
of MS (<€1-10 million per MS)
nrMs: Not quantified for EU27, but:
- Costs to pesticide sector through loss of approved substances,
costs of product development and product substitution to the
farming sector.
PFAS:
Not
quantified
for EU27,
but:
- Contamin
ated soil
remediati
on €5
million -
€760
million
- Legacy
pollution
landfill
sites –
€690,000
up to €77
million
per site
Not quantified
Groun
dwater
Direct
administr
ative
costs
Not
applicable
- €0
Not
applicable
- €0
Not quantified Not quantified Not
quantified
Not quantified
but no
significant
additional
costs for risk /
status
assessments
122
II. Overview of costs – Preferred option
Cost type
Citizens /
Consumers
Businesses Administrations
One-off Recurrent One-off Recurrent One-off Recurrent
Direct
regulator
y fees
and
charges
Not
applicable
- €0
Not
applicable
- €0
Not quantified Not quantified Not
applicable
- €0
Not applicable
- €0
Direct
enforcem
ent costs
Not
applicable
- €0
Not
applicable
- €0
Not quantified Not quantified Not
quantified
Additional
analytical costs
for EU27:
PFAS: €45-48
million
Pharma: €2
million
nrMs: €4-5
million
Indirect
costs
Not quantified but
proposals could lead
to:
- Possible societal
impacts from loss
of use of
pharmaceuticals -
Restricting use
could impact on
health and well-
being of people
and animals
where
alternatives have
side effects /
different efficacy.
Not quantified but proposals could lead to:
Pharmaceuticals:
- additional costs associated with substitution of
pharmaceuticals and availability of alternatives (product
substitution viable for Sulfathemoxazole but unlikely for
Carbamazepine)
nrMs:
- Restrictions on use impact on farming sector and crop
yields. Substitute pesticides are available and can be
cheaper or up to 100 times more costly that permitted
parent pesticides
- Un-intentional impacts for example glyphosate is used
to destroy cover crops, which are used to mitigate
nutrients in run-off / leaching from agricultural fields
over winter
- Increased data requirements could make gaining
authorisation of new products more challenging.
Not
applicable
- €0
Not applicable
- €0
Digital
isation,
admini
strativ
e
stream
lining
and
better
risk
manag
ement
option
s
Direct
adjustme
nt costs
Not
applicable
- €0
Not
applicable
- €0
Not quantified for EU27, but:
Option 2 (Guidelines on the monitoring of groups/ mixtures of
pollutants): Costs due to monitoring of estrogen are low, but
possible measure to be taken due to monitoring results may be
substantial.
Policy option 3 – Reporting and classification - sub-option (a):
Establish an automated data delivery mechanism for the EQSD
and the WFD. This option makes best use of the European
Environment Agency’s (EEA) and IPBES’s DPSIR frameworks.
Contributes to a more streamlined, simplified, modern, digital
monitoring and reporting as well as uptake of new digital and
earth observation technologies resulting in real-near time data
flows Consequently, it will also contribute to a streamlined and
effective (bi)annual presentation of monitoring results.
Option 8 (Repository of standards of EQSs for the RBSPs):
agreeing on RBSPs EQSs would likely lead to substantial costs for
MS for implementation of substantive measures where necessary.
Option 9 (Allowing flexible adaptation to scientific progress and
knowledge by updating the lists of pollutants and their EQS
(under both SWD and GWD) by way of delegated acts
Not
quantified
for EU27,
but:
Option 2
(Guidelines
on the
monitoring
of
groups/mix
tures of
pollutants):
Limited
cost to
develop the
guidance
document.
Not quantified
for EU27, but:
Option 6 (An
obligatory
groundwater
watchlist):
Additional cost
for monitoring
and reporting
Monit
oring,
reporti
ng and
Direct
administr
ative
costs
Not
applicable
- €0
Not
applicable
- €0
Not
quantified
Not quantified
123
II. Overview of costs – Preferred option
Cost type
Citizens /
Consumers
Businesses Administrations
One-off Recurrent One-off Recurrent One-off Recurrent
admini
strativ
e
stream
lining
option
s
Direct
regulator
y fees
and
charges
Not
applicable
- €0
Not
applicable
- €0
Not quantified Not quantified NA NA
Direct
enforcem
ent costs
Not
applicable
- €0
Not
applicable
- €0
Not quantified Not quantified Mon Not quantified
for EU27, but:
Option 1
(Guidelines on
the monitoring
of groups/
mixtures of
pollutants):
Minor
monitoring
costs of
estrogens.
Option 2b (An
obligatory
groundwater
watchlist):
Additional cost
for monitoring
and reporting.
Option 3d
(Repository of
standards of
EQSs for the
RBSPs):
substantial
costs for MS
for
implementatio
n of
monitoring
(following the
agreement on
RBSPs EQSs).
Indirect
costs
Substitutio
n
Prices
NA NA
Costs related to the ‘one in, one out’ approach
Total
Direct
adjustme
nt costs
NA NA NA NA NA NA
Indirect
adjustme
nt costs
NA NA NA NA NA NA
Administ
rative
costs (for
offsetting
)
NA NA NA NA NA NA
124
1. RELEVANT SUSTAINABLE DEVELOPMENT GOALS
III. Overview of relevant Sustainable Development Goals (SDG) – Preferred Option(s)
Relevant SDG Expected progress towards the Goal Comments
Goal 6: Ensure access to water and sanitation for all
SDG target 6.1:
By 2030, achieve universal and equitable
access to safe and affordable drinking
water for all
Decreased levels of pollution of the main sources of
drinking water. By applying the most cost efficient
solution (usually prevention / action at source) costs of
drinking water should remain affordable.
This initiative will increase the
quality both in terms of human
health and environmental
aspects of surface and
groundwater, and will thus also
increase the safety of the two
by far largest sources for
producing drinking water.
SDG 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
The legislation will lead to an expanded and updated list
of pollutants, where MS need to ensure compliance with
for their groundwater and surface water. Limit values are
set so as to minimise risk on health and environment.
Water and sludge recycling rates are dependent on the
degree of pollution. By focusing on upstream /
preventive action recycling will be facilitated.
This initiative will improve
water quality by setting stricter
environmental quality
standards and bring more
hazardous substances under
control and thus contributes to
minimising the release of
hazardous substances into
surface and groundwater.
Indicator 6.3.2: Proportion of bodies of
water with good ambient water quality
More categories of pollutants, at stricter limit values will
be set. By introducing more adequate methodologies, it
will allow for more focused policy intervention, in the
longer run leading to a larger number of water bodies in
good quality.
This legislation will further
incentivise action against a
larger range of pollutants, at
stricter norms. In the longer
run
Goal 12: Ensure sustainable consumption and production patterns
SDG Target 12.4:
By 2020, achieve the environmentally
sound management of chemicals and all
wastes throughout their life cycle, and
significantly reduce their release to air,
water and soil in order to minimize their
adverse impacts on human health and the
environment
More pollutants and groups of pollutants will be covered,
at stricter limit values. This will require more integrated
chemicals management, in particular leading to more
action upstream / at source. In particular to facilitate
circularity and avoid undue energy use e.g. for sludge
management, preference will often go to upstream
solutions.
This initiative will allow a
more adequate, future proofed
management of chemicals in
the aquatic environment. It will
allow more effective and
targeted interventions when
risk to the environment and
health is identified.
Goal 14: Conserve and sustainably use the oceans, seas and marine resources
SDG target 14.1
By 2025, prevent and significantly reduce
marine pollution of all kinds, in particular
from land-based activities, including
marine debris and nutrient pollution
Reductions can be expected for pharmaceuticals,
industrial chemicals, pesticides and – in the longer run –
microplastics, combining both source and end of pipe
measures. Ultimately less pollutants will be transported
to the marine environment.
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ANNEX 4: ANALYTICAL METHODS USED IN PREPARING THE IMPACT ASSESSMENT
1. Dynamic baseline
A dynamic baseline reflects the likely changes to emissions and by-proxy environmental
concentrations in a business-as-usual / do nothing scenario covering the short-to-medium
term picture until 2030. External drivers that may affect emissions and environmental
concentrations can be policy or non-policy related, as described below.
1.1. Policy drivers
The timing of changes in emissions to the environment depends on timing or focus of
legislation or strategies. Therefore, for PFAS which are banned and no longer used for a
specific purposes (e.g. fire-fighting foams) the trend decreases sooner than for PFAS which
exist in products such as textiles where they will continue to be released to the environment
even if use is phased-out. For nrMs with a banned parent compound, their formation and
release to the environment will depend on the rate of degradation of the parent compound
which is a function of environmental factors such as temperature, sunlight, moisture content,
presence of co-metabolites and micro-organisms capable of breaking down the parent
compound. The decrease in emissions will be faster than for those whose parent compounds
are not banned.
Innovation and digitalisation
The implementation of the INSPIRE Directive 2007/2/EC may also have impacts on
monitoring and reporting. The Directive lays down the rules establishing the infrastructure
for spatial information in the European Union in support of Union environmental policies and
policies or activities that may have an impact on the environment (Art. 1(1)). The aim is to
deliver useful, standardised and high-quality data in order to formulate, implement, monitor
and evaluate European, national and local policy. The Directive does not set requirements for
the collection of new data, or for reporting to the Commission but, rather, lays down a
number of rights and obligations regarding the sharing of spatial data sets. Annex I to the
Directive lists 34 data themes which are covered under INSPIRE, including data that is
commonly reported under the Water Information System for Europe (WISE). The set-up of
INSPIRE is aimed at facilitating data-harvesting and reaping benefits of technological
developments, reducing burdens of environmental monitoring and reporting while enabling
information to be collected and utilized. In addition to the Implementing Rules, non-binding
Technical Guidance documents describe detailed implementation aspects and relations with
existing standards, technologies, and practices. As such, the INSPIRE Directive not only
requires MS to disclose their national data that must be collected on the bases of other
environmental policy frameworks (including the WFD), but also sets a standard for reporting
data and making it publicly accessible. The INSPIRE Directive was set to come into full
force by 2021.
In the context of the Chemicals Strategy for Sustainability, and building on the Information
Platform for Chemical Monitoring (IPCheM), the Commission is looking at establishing a
data-harvesting system for chemical monitoring and toxicity data. This could introduce
provisions for a harmonised approach to data harvesting across a range of chemicals-related
policy sectors.
126
One caveat is that, as the policy landscape continues to evolve, there are likely to be further
changes in decision making and implementation, making it hard to quantitatively predict the
impacts of the dynamic baseline.
1.2. Non-policy drivers
Climate change
Climate change is leading to more unpredictable weather events with greater extremes
including both increased rainfall (intensity) and increased duration and frequency of dry
seasons and droughts. More frequent and heavier rainfalls can increase urban run-off and
storm water overflows from sewer systems, thus placing additional pollutant-load pressure on
water bodies, whereas an increase in the duration and frequency of dry seasons and droughts
can result in reduced dilution of pollutants in surface waters. Both phenomena can
significantly affect the status of water bodies. Dry periods often translate into increased
abstraction for many uses of both surface and groundwaters, which can put chemical status at
risk. Furthermore, droughts can cause additional stress on freshwaters used as drinking water
sources, in particular groundwater aquifers. The impacts of climate change can thus be
expected to make existing pollution-related problems worse.
Growth in urbanisation and ageing populations
Trends in the current development of society are likely to have an impact on water resources,
primarily through increased pressures. Two particularly important social developments that
may impact surface and groundwater resources are urbanisation and the aging of populations.
Urbanisation is defined as the process by which natural or semi-natural land is converted into
urban uses. The urban environment is largely impervious to water, resulting in the water
transport having to occur through artificial means (e.g. sewer networks). Due to the
impermeability of urban areas, water retained and collected, often to reduce flood risk, can
contain several pollutants from different sources, and therefore present a risk to water bodies
when discharged. As a result, an increasing degree of urbanisation will have a direct impact
on the quantity of contaminants entering the environment. Studies have projected that
between 2015 and 2030, built-up areas within the EU will grow to occupy 7% of EU territory
and by 2050 it is estimated that 83.7% of the EU population will be living in urban areas
(106).
In addition, demographic changes (in relation to population size and age) may also have an
impact on contaminant release and therefore increase the pressure on water treatment
facilities. For instance, projected population trends that show an increase in the share of
elderly people, relative to the total population, may have an impact on the consumption of
pharmaceuticals in the future. The consequent release of pharmaceutical compounds into
waste water collection and treatment facilities is likely to increase the pressure on those
facilities, as well as on the environment as pollutant loads increase.
Innovation and digitalisation
Innovation and digitalisation are key priorities for the water sector in order to align the sector
with EU ambitions such as those set out in the European Green Deal. In the context of water
management, the metering of water supply/consumption, and the monitoring and reporting of
water quality, are increasingly modernising by automation processes, remote sensing and
remote data transmission. For example, the fitting of waste water treatment plants with smart
127
remote monitoring technologies that allow telemetric can reduce operating costs, improve
plant lifetimes and facilitate the switching of plant operations depending on different
conditions. The increased use of multi-parameter (fluid) sensor technologies is another
example. Furthermore, technologies are evolving rapidly that could facilitate data processing
and information sharing in the water sector.
1.3. Results of the dynamic baseline exercise for surface and groundwater pollutants
A qualitative analysis of the dynamic baseline for surface water is presented in Table A4.1,
whereas substances proposed for listing in Annex I and Annex II of the GWD are covered in
Table A4.2. The tables provide an overview of the relevant legislation and the best
understanding of how it is evolving, an overview of how this evolution may impact the
emissions of candidate and existing priority substances as well as substances on the List
Facilitating Review of the GWD Annexes. Note that the dynamic baseline situation, in terms
of production, use and emissions, is in most cases subject to significant uncertainty.
128
Table A4.1: Dynamic baseline for surface water pollutants
Substance Main Uses
Non-policy
underlying
drivers
Policy
(potentially)
driving emission
reduction
Examples of specific
initiatives / actions
for emission
reduction
Overall
outcome
Possible addition of priority (hazardous) substances
Estrogenic
substances (E1,
E2, EE2)
Used as
medication, e.g.
in hormonal
birth control,
menopausal
hormone
therapy,
treatment of
hormone-
sensitive
cancers.
Aging population
with potential
increase in use of
HRT.
Aging population
decrease use of
contraceptive pill.
Industrial
Emissions
Directive (IED);
Strategic Approach
to Pharmaceuticals
in the Environment
(PiE);
Classification and
Labelling of EU
Pharmaceutical
Strategy; Urban
Wastewater
Treatment
Directive
(UWWTD), but
possibly not before
2030, Directive on
the Sustainable
Use of Pesticides
(DSUP),
Classification,
Labelling and
Packaging (CLP)
of chemical
substances and
mixtures
Regulation
Changes under UWWTD
could have an impact, but
unlikely to be widely
implemented before
2030.
Some
emissions
minimisation
s
(10-30%)
Macrolide
antibiotics
(azithromycin;
clarithromycin;
erythromycin)
Used in animal
farming and as
medication to
treat various
infections.
Changes to way
antibiotics are used
in farmed animals.
Rate of human use
difficult to predict in
future years. EU
Population is largely
static albeit aging.
IED; Pharma
legislation
(veterinary); PiE;
EU Pharmaceutical
Strategy;
UWWTD; Farm to
fork strategy (F2F).
Pre-emptive use of
antibiotics for farmed
animals ceased end of
2019.
Pharmaceutical strategy
specifically includes
initiatives to address anti-
microbial resistance
Significant
emissions
reductions
(30-50%)
Carbamazepine Used as
medication to
treat trigeminal
neuralgia,
diabetic
neuropathy and
bipolar disorder.
No specific
underlying drivers
identified.
IED; PiE; EU
Pharmaceutical
Strategy; UWWTD
EU pharmaceutical
Strategy could assess
alternative medicines.
Some
emissions
reductions
(10-30%)
Diclofenac Used as
medication to
treat mild to
moderate pain,
or signs and
symptoms of
osteoarthritis or
rheumatoid
arthritis.
Aging population,
potential increase in
use, depending on
national approaches.
PiE; EU
Pharmaceutical
Strategy; UWWTD
No specific initiatives
identified.
Some
emissions
reductions
(10-30%)
Ibuprofen Used as
medication to
reduce fever
and treat pain or
inflammation
caused by many
conditions such
Aging population,
potential increase in
use, depending on
national approaches.
PiE ; EU
Pharmaceutical
Strategy; UWWTD
No specific initiatives
identified.
No change.
(+/- 10%
current
emissions)
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Substance Main Uses
Non-policy
underlying
drivers
Policy
(potentially)
driving emission
reduction
Examples of specific
initiatives / actions
for emission
reduction
Overall
outcome
as headache,
toothache, back
pain, arthritis,
menstrual
cramps, or
minor injury.
Neonicotinoids
(Acetamiprid;
Clothianidin;
Imidacloprid;
Thiacloprid;
Thiamethoxam
)
Used to control
insect pests in
agriculture
(crops,
vegetables,
fruits), animal
farming (e.g. for
invertebrate
pest control in
fish farming).
Use as plant
protection products
(PPPs) now largely
banned; however
very few chemical
alternatives, so
emergency
authorisations have
been used. Uses as
biocides still
approved for four
out of five neonics.
Usage rates not
expected to increase
significantly up to
2030.
EQSD; GWD;
DWD; Biocidal
Products
Regulation (BPR);
Plant Protection
Products
Regulation
(PPPR);
Sustainable Use of
Pesticides
Directive (SUPD)83
F2F could be important,
but the point was made
that the approvals for use
as a pesticide have been
removed for four
neonicotinoids, and strict
controls for acetamiprid.
Therefore, difficult to
further control use.
Primary driver for
emission reduction will
be PoMs under WFD
with synergistic benefits
to other pesticides.
Acetamiprid,
clothianidin, and
imidacloprid are all
candidates for
substitution under BPR
which should aid phase-
out.
Some
emissions
reductions
(10-30%)
Pyrethroids
(Bifenthrin;
Deltamethrin;
Esfenvalerate;
Permethrin)
Used to control
insect pests in
agriculture,
public health
and animal
farming.
Approvals in place
under both PPPR
and BPR, but
consistency would
need to be ensured in
the best possible
way. Very limited
choice of chemical
alternatives. Use
could increase in the
future for a variety
of reasons.
EQSD, GWD,
DWD; BPR; F2F;
PPPR; SUPD
F2F sets targets to reduce
the use of pesticides
which could aid
emissions.
Under BPR Bifenthrin is
a candidate for
substitution which aid its
phase-out.
Some
emissions
reductions
(10-30%)
Nicosulfuron Used as an
herbicide to
control weeds.
Difficult to predict; a
range of chemical
alternatives exist.
Assume usage rates
remain broadly
stable.
EQSD, GWD,
DWD; PPPR;
SUPD
No specific initiatives
identified.
Some
emissions
reductions
(10-30%)
Glyphosate Used as an
herbicide to
control weeds
and grasses.
Current approval
expires December
2022. Based on
communication with
Commission
approval is likely to
be extended at least
12 months while
review continues.
Further extension
possible.
Usage rates are
already high, could
assume continued
EQSD, GWD,
DWD; PPPR;
SUPD
The assessment of
glyphosate is ongoing, at
present continued
authorisation is expected.
It is not directly
mentioned in the F2F
strategy, and based on
current usage rates and
EU policy, emissions are
assigned to the category
‘no change’.
No change.
(+/- 10% of
current
emissions)
83
Revision of SUPD is ongoing.
130
Substance Main Uses
Non-policy
underlying
drivers
Policy
(potentially)
driving emission
reduction
Examples of specific
initiatives / actions
for emission
reduction
Overall
outcome
rates at a similar
level. Question of
whether high usage
rates lead to
tolerance, and
greater use of
alternatives or co-
mixtures with
glyphosate?
Triclosan Used as an
antibacterial
and antifungal
agent in some
consumer
products, e.g.
toothpaste,
soaps,
detergents, toys,
surgical
cleaning
treatments. Also
added to other
materials, such
as textiles, to
make them
resistant to
bacteria.
Remaining use as a
biocide in limited
range of
applications.
Candidate for
substitution. Expect
future use to decline.
EQSD, GWD,
DWD, BPR;
Cosmetics
Candidate for substitution
under BPR.
Some
emissions
reductions
(10-30%)
PFAS Used in stain-
and water-
resistant fabrics
and carpeting,
cleaning
products, paints,
and fire-fighting
foams.
The PFAS market
has been through
successive step
changes as EU and
global policy has
intervened. Expect
further
diversification, and
role of
fluoropolymer as a
replacement for at
least some non-
polymeric
applications. Legacy
issues will from
continued pollution
from substitution
and from already
polluted hot spots
will remain. Those
will still creating
future problems for
surface and
groundwater
concentrations levels
if unaddressed.
Therefore, policy
actions under the
WFD, EQSD and
GWD will remain
necessary.
IED, EQSD;
GWD; DWD;
REACH, Food
contact materials
(FCM); REACH;
Waste legislation;
Chemicals Strategy
for Sustainability
(CSS); expect
revised UWWTD
to have further
impacts, but
possibly not before
2030.
Restriction on the use of
PFAS. Development of
analytical standards under
DWD.
Significant
emissions
reductions
(30-50%)
Bisphenol A Used in the
manufacture of
various plastics,
including for
Some restrictions on
Bisphenol A already
in place, and
substitution from the
IED; DWD;
REACH; FCM
New standard adopted
under DWD, which could
aid emission reduction
earlier in the life-cycle.
No change.
(+/- 10% of
current
emissions)
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Substance Main Uses
Non-policy
underlying
drivers
Policy
(potentially)
driving emission
reduction
Examples of specific
initiatives / actions
for emission
reduction
Overall
outcome
shatterproof
windows,
eyewear, water
bottles, and
epoxy resins
that coat some
metal food cans,
bottle tops, and
water supply
pipes.
same family in use.
Many of the issues
for emissions may
now relate to legacy
aspects
(polycarbonate and
epoxy resins).
Assume usage rates
broadly stable.
However, given the
complex issues at play,
expect limited impact.
Assume emissions are
largely unchanged.
Micro-plastics Intentionally
added to a range
of products
including
fertilisers, plant
protection
products,
cosmetics,
household and
industrial
detergents,
cleaning
products, paints
and products
used in the oil
and gas
industry. Also
used as the soft
infill material
on artificial turf
sports pitches.
Two issues –
intentional use of
micro-plastics and
secondary micro-
plastics from use of
plastic more widely.
Controls likely for
intentional use,
expect usage rates to
decline by 2030.
Legacy issues84
will
from continued
pollution from
continued pollution
and from loads of
plastics already
present in the
environment will
remain. Those will
still creating future
problems for surface
and groundwater
concentrations levels
if unaddressed.
Therefore, policy
actions under the
WFD, EQSD and
GWD will remain
necessary
UWWTD;
REACH; Waste
legislation; Marine
Strategy
Framework
Directive (MSFD),
EU Plastics
Strategy (incl.
upcoming EU
initiatives on
micro-plastics),
product design
requirements under
the Ecodesign
Directive,
Sustainable
Textiles Strategy
and other
Sustainable
Products Initiative
(SPI) actions.
REACH restriction on the
intentional use of micro-
plastics.
EU initiatives on micro-
plastics will tackle
unintentional releases.
Some
emissions
reductions
(10-30%)
Silver Used in coins,
silverware,
jewellery,
mirrors and
windows as
well as in
various
industrial and
electrical
applications,
medicine (in
surgical
equipment,
wound
dressings,
ointments) and
even film
photography.
Complex issue as
this is a naturally
occurring substance
but also used in
silver containing
biocides and PCP.
There will also be
legacy issues (e.g.,
mine drainage,
landfill, etc.). Some
usage rates can be
assumed to be
broadly stable while
others like the use of
silver as anti-
bacterial agent and
in a wide range of
products is
IED; DWD; BPR;
Waste legislation
ECHA Biocides
committee rejected
approval of four silver
containing active
substances85
due to
unacceptable risks for
human health when used
as part of activated
carbon water filters.
Possibility for silver to be
selected as key
performance indicator
under IED BREF process.
Some
emissions
reductions
(10-30%)
84
Plastics degrade slowly (often over hundreds to thousands of years) and absorb persistent organic pollutants. Consequently, microplastics are
classified as PHS. Specific surface degradation rates (SSDR) are sued to extrapolate half-lives. Mean SSDRs for high density polyethylene (HDPE) in
the marine and aquatic environments lead to estimated half-lives ranging from 58 years (bottles) to 1200 years (pipes) (125).
85
https://echa.europa.eu/-/biocides-committee-proposes-not-to-approve-four-silver-containing-active-substances
132
Substance Main Uses
Non-policy
underlying
drivers
Policy
(potentially)
driving emission
reduction
Examples of specific
initiatives / actions
for emission
reduction
Overall
outcome
increasing. Finally, it
must also be
considered that
silver is the basis for
important
nanomaterials.
Possible amendment of existing priority (hazardous) substances
Chlorpyrifos Past use as an
insecticide to
control foliage
and soil-borne
insect pests on a
variety of food
and feed crops.
Use is banned in the
EU, and recently
nominated as a POP
under the Stockholm
Convention.
EQSD; GWD;
DWD
Persistent Organic
Pollutants (POPs)
Regulation
Already banned in the
EU. Nominated as a POP
to the Stockholm
Convention in 2021.
Some
emissions
reductions
(10-30%)
Cypermethrin Used as an
insecticide to
control a range
of pests in
arable and
livestock
farming, homes
and gardens,
and in public
and commercial
buildings.
Also used as a
medication to
treat parasitic
skin diseases.
Approved as both a
PPP and biocide,
with approvals to
2029 and 2030
respectively. Expect
usage rates to
increase as pressure
on other pyrethroids
drives substitution.
EQSD; GWD;
DWD; F2F; SUPD
F2F may provide some
positive impacts for
emission reduction of
pesticidal use. Biocidal
use unaffected.
Some
emissions
reductions
(10-30%)
Dioxins Mainly by-
products of
industrial
practices, e.g.
production of
some
chlorinated
organic
compounds,
chlorine
bleaching of
pulp and paper.
Also formed
during
combustion
processes
(including
smoking).
No commercial use.
Major emission
sources are now
largely under control
(metals, incineration,
power generation).
Emissions in the EU
now largely static,
and further reduction
challenging.
IED; POPs
Regulation
No specific initiatives
identified.
No change.
(+/- 10% of
current
emissions)
Diuron Past use as a
pre-emergence
herbicide for
general weed
control on
noncroplands
and also to
control weeds
and algae in and
around water
bodies and as a
component of
marine anti-
fouling paints.
Approval ended
September 2020.
Expect all remaining
stocks to be
exhausted in near
term.
EQSD; GWD;
DWD
Use ceased recently, but
the very high persistence
in soil, could create
legacy issues that limit
the emission reduction up
to 2030.
Some
emissions
reductions
(10-30%)
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Substance Main Uses
Non-policy
underlying
drivers
Policy
(potentially)
driving emission
reduction
Examples of specific
initiatives / actions
for emission
reduction
Overall
outcome
Fluoranthene Used as a
fluorescent
agent for non-
magnetic metal
surface
inspection,
synthesizing
yellow and blue
vat dyes, and
manufacturing
medicine.
PAH family member
found in crude oil
and distillates. Used
in some
manufacturing
processes relating to
oils, dyes, and
speciality chemicals.
No specific
underlying drivers
identified; assume
use is stable.
EQSD; GWD;
DWD; REACH
No specific initiatives
identified.
No change.
(+/- 10% of
current
emissions
PAHs Occur naturally
in coal, crude
oil, and
gasoline.
Released during
combustion
processes
(including
smoking).
No commercial use.
Formed as mixtures
within fossil fuels
and crude oil.
IED; EQSD Further emission
reduction under IED and
EQSD.
Some
emissions
reductions
(10-30%)
Heptachlor /
Heptachlor
epoxide
Past use as an
insecticide to
control various
insect pests, and
for soil and seed
treatment, wood
protection.
Banned in the EU 40
years ago, but highly
persistent.
EQSD, POPs
Regulation
No specific initiatives
identified.
No change.
(+/- 10% of
current
emissions)
Hexachloro-
benzene
Past use as a
fungicide for
seed treatment,
especially on
wheat to control
the fungal
disease bunt.
Banned in the EU 45
years ago, but highly
persistent.
EQSD, POPs
Regulation
No specific initiatives
identified.
No change.
(+/- 10% of
current
emissions)
Hexachloro-
butadiene
Used in the
manufacture of
rubber
compounds, in
the production
of lubricants, as
a fluid for
gyroscopes, as a
heat transfer
liquid, and in
hydraulic fluids.
Not intentionally
used in the EU since
end of the 1980s.
Possible
contamination of
imported products.
But addition to
Stockholm
Convention will
drive down use.
EQSD, POPs
Regulation
Added to Stockholm
Convention in 2017.
However, EU use ceased
in 1980s, emissions
should already be very
low.
No change.
(+/- 10% of
current
emissions
Mercury Wide range of
uses e.g. in
thermometers,
barometers,
manometers,
blood pressure
meters, float
valves, mercury
switches,
mercury relays,
fluorescent
lamps and other
devices.
Natural occurring
substance. Wide
range of uses but
significant steps over
the last decade to
control emissions.
No specific non-
policy drivers
identified.
EQSD, GWD,
DWD; IED; SSD;
Restriction of
Hazardous
Substances (RoHS)
Directive, Mercury
Regulation,
Minamata
Convention
Priority for emission
reduction to support
EQSD. Including Key
Performance Indicator
under IED, controls under
Mercury Regulation, and
waste legislation.
Reductions from new
provisions for Large
Combustion Plans and
decarbonising industry.
Significant
emissions
reductions
(30-50%)
Nickel Used to make
stainless steel
and other
Similar issues as for
other metals,
naturally occurring
EQSD; GWD;
DWD; IED;
REACH
Possible work under IED
BREF process.
Some
emissions
reductions
134
Substance Main Uses
Non-policy
underlying
drivers
Policy
(potentially)
driving emission
reduction
Examples of specific
initiatives / actions
for emission
reduction
Overall
outcome
alloys, for
plating, foundry
and batteries.
substance. No
specific underlying
drivers identified.
(10-30%)
Nonylphenol Used for
industrial
processes (e.g.
for washing and
dying of yarns
and fabrics) and
in consumer
laundry
detergents,
personal
hygiene,
automotive,
latex paints, and
lawn care
products.
Intentional use has
ceased. Imported
textiles still an issue
and likely to
continue to be the
case in future.
EQSD; GWD;
DWD; REACH;
UWWTD, but
unlikely before
2030
UWWTD revision could
tackle this issue;
otherwise EQSD will be
the main driver.
Some
emissions
reductions
(10-30%)
PBDEs Used as flame
retardants in
plastics,
furniture,
upholstery,
electrical
equipment,
electronic
devices, textiles
and other
household
products.
Use has largely
ceased. Primarily a
legacy issue for in-
use stock and
landfill.
IED; POPs
Regulation; Waste
legislation
Low POP content
threshold for PBDEs
planned to be reduced.
Some
emissions
reductions
(10-30%)
Tributyltin Past use as a
biocide in anti-
fouling paint
applied to
commercial
vessels,
pleasure craft
and mariculture
equipment.
No longer used, but
diffuse sources exist
from past use.
EQSD, GWD,
DWD,
International
Convention on the
Control of Harmful
Anti-fouling
Systems on Ships
(AFS) (the HAFS
Convention)
EQSD would be the main
driver for emission
reduction.
Some
emissions
reductions
(10-30%)
Dicofol Past and some
current use for
ornamental
plants and fruits
Dicofol containing
DDT under severe
restriction in Europe
Stockholm
Convention, EQSD
No change.
(+/- 10% of
current
emissions
Hexabromo-
cyclododecane
Used as flame-
retardant within
insulation
boarding,
plastics, and
textiles
Not produced or
imported into
Europe
Stockholm
Convention Annex
A EQSD
No change.
(+/- 10% of
current
emissions
135
Table A4.2: Dynamic baseline for groundwater pollutants
Substance Legislation or strategy driving change Overall outcome
Pharma-
ceuticals
Pharmaceutical legislation & strategy
The Veterinary Medicinal Products
Directive 2001/82/EC; Directive
2001/83/EC — Community code relating
to medicinal products for human use
+ from drive to reduce anti-microbial resistance in the
environment which reduces use as veterinary
medicines
EC pharmaceutical strategic approach
Various guidelines on Environmental Risk
Assessment for pharmaceuticals
0 Environmental risk assessment process may be too
weak to have an impact on wider groundwater
pollution meaning a limited change from EU
pharmaceuticals strategy
Industrial emissions Directive (IED) + at manufacturing sites for pharmaceuticals and
future expansion of scope to include intensive cattle
farming
EQSD + Carbamazepine, Erythromycin and Clarithromycin
under consideration as PS
PFAS GWD ++ for PFAS based on prevent and limit requirements
and TVs.
REACH Regulation + relevant PFAS (HFPO-DA (better known as
GenX86
) has replaced PFOA as processing aid for
producing fluoropolymers and PFBS) for future
manufacturing
Persistent Organic Pollutants (POPs)
Regulations
+ for relevant PFAS (PFOS has already been
restricted in the EU for more than 10 years)
Food Contact Materials Regulation (EC)
No 1935/2004; and Commission
Regulation (EU) No 10/2011
+ for PFAS (PFOA, PFECA and ADONA) not
permitted for use in food contact materials. EFSA
threshold for PFAS TWI of 4.4 ng/kg)
Industrial Emissions Directive (IED) + at manufacturing sites for PFAS
Drinking Water Directive (DWD) recast ++ in the long term
EQSD + in long term for GWBs connected to SWBs. PFOS
is already a Priority Substance with an EQS of
0.00065 µg/l.
nrMs of
pesticides
GWD ++ based on measures to address pesticides through
Annex I and Annex II listing and TVs
Regulation No 1107/2009 concerning the
placing of plant protection products on the
market
++ for nrMs with banned parent compounds.
++ where permitted parent compound is reviewed in
light nrMs in groundwater
Directive 2009/128/EC, establishing a
framework for community action to
achieve the sustainable use of pesticides
(SUPD)
+ for nrMs with reduction in use of parent product.
SUPD supports the Farm to Fork initiative, which
aims to reduce hazardous pesticide use by 50% by
2030.
Biocidal Products Regulation + for Tolylfluanid and Dichlofluanid
Stockholm Convention + for nrMs derived from POPs parent compounds
Drinking Water Directive (DWD) recast + for nrMs
MS drinking water standards + for nrMs
EQSD + in long term for GWBs connected to SWBs.
Glyphosate (nrM parent) is under consideration as PS
86
In 2019, GenX was identified as a Substance of Very High Concern (SVHC): https://echa.europa.eu/registry-of-svhc-intentions/-
/dislist/details/0b0236e1832708a2
136
2. Distance to target
As explained in the main text of the SWD (in particular section 6.1.1), the distance to target
cannot be determined for each Member State vis-à-vis each substance or group of substances
under consideration because the monitoring data underpinning such measurement are either
anonymised, incomplete or both. For the candidate priority substances, data from the surface
water watch list is obtained from the JRC in an anonymised format, in which data reported by
individual MS are separate but the counties are not named (e.g. it is clear which data belong
to Country 1, but no indication of which MS it is). In the case of existing PS, data to inform
the distance to target assessment is largely obtained from the WFD reporting, where reporting
measured concentrations is voluntary, leading to a fragmented dataset. In the case of
emerging groundwater pollutants, the voluntary nature of monitoring under the Groundwater
Watch List limits the amount of data available. In addition, the measurements are reported in
concentration ranges (e.g. <LOQ, ≥LOQ-0.05 µg/L, 0.05-0.1 µg/L etc.), therefore it is not
possible to know exact concentrations (22).
Considering the above, it was necessary to adapt the distance to target methodology keeping
in mind the specific data availability for new PS, existing PS and LFR substances. The
sections below explain the approaches taken to assess the scale and magnitude of the gap
between the current concentrations in surface and groundwater and the new quality standards
considered for each pollutant.
2.1. Substances for addition to PS list
Criteria shown in Table A4.3 were developed to assess the ‘distance to target’ for candidate
priority substances (PS). They allow for a pathway 1 (data -rich) or a pathway 2 (data -poor)
assessment, depending on the number of MS (MS) reporting data. The criteria evaluate two
metrics: the scale of the problem (i.e. how wide-spread geographically are exceedances of the
proposed EQS, and, in the case of pathway 2, the temporal spread (i.e. how frequently do we
see exceedances occur consistently year on year?), and the magnitude of the problem (i.e.
how large are the exceedances above the EQS?). Substances within each pathway are listed in
Table A4.4 below. It is worth to note that the uncertainty in the results for substances
assessed under pathway 2 will be bigger than for those under pathway 1. For the available
monitoring data see Table A11.1 in Annex 11.
Table A4.3: Criteria used to assess the size of the gap in EQS compliance
Size of gap
Decision tree pt 1. Monitoring data exists for ≥14 MS
(assumed to include EU27+NO). Use these criteria.
Decision tree pt 2. Monitoring data exists for ≤14 MS
(assumed to include EU27+NO). Use these criteria.
Small
Scale: Predicted exceedances in ≤33% of MS based on
the monitoring data available.
Predicted exceedance is infrequent over the temporal trend
demonstrating a ‘patchy’ picture. Additionally, there are a
high level of non-detects in the sample set (>50%), and
scale of the exceedance for any one year for AA or MAC is
≤50% of the predicted threshold. (i.e. maximum AA /MAC
is 1.5 x the EQS).
Magnitude: Based on AA & MAC exceedances
compared to predicted EQS + scale of non-detects as a
measure of how widespread the problem is nationally
and how significant the scale of the exceedances.
Medium
Scale: Predicted exceedances in ≥33% but ≤66% of MS
based on monitoring data available.
Predicted exceedances occur consistently year on year
across the temporal trend for available monitoring data.
Volume of non-detects in the sample is below 30%, scale of
the exceedance for AA and/or MAC is up to 30% for all
years.
Magnitude: Based on AA & MAC exceedances
compared to predicted EQS + scale of non-detects as a
measure of how widespread the problem is nationally
and how significant the scale of the exceedances.
Large
Scale: Predicted exceedances in ≥66% of MS based on
monitoring data available.
Predicted exceedances occur consistently year on year
across the temporal trend for available monitoring data.
Volume of non-detects in the sample is below 30%, scale of
the exceedance for AA and/or MAC is above 50% for all
Magnitude: Based on AA & MAC exceedances
137
compared to predicted EQS + scale of non-detects as a
measure of how widespread the problem is nationally
and how significant the scale of the exceedances.
years. (i.e. maximum AA/MAC is 1.5 x EQS for all years).
Table A4.4: Data-rich and data-poor candidate priority substances
The methodology followed a 2-stage process. For each substance, the screening criteria were
used to rank the substance in a category defining the distance to target (i.e. compliance with
the new EQS). This defines the distance to target as ‘large’, ‘medium’, or ‘small’. Then, the
dynamic baseline was applied to assess whether the scale and magnitude of the exceedances
would be altered by expected changes or effects in other policy areas and mean that some
substances need to be re-assigned. The completion of this process did identify a small number
of substances, where as a result of emission reduction under the dynamic baseline the size of
the gap could be expected to shrink in the coming years, meaning that substances could be
demoted to a lower group. No substances were identified against the dynamic baseline where
they needed to be promoted up a group in terms of the size of the gap increasing.
Table A4.5: Summary of the distance to target assessment for candidate priority substances
Substance
category
Substance
Current Distance to Target87
Expected emission
change (Dynamic
Baseline)
Overall
expected
Distance to
Target
Scale
% of MS with
exceedances
against total no. of
MS providing
monitoring data
Magnitude
% of MS with
mean monitored
concentration
>30% of
recommended
EQS
Estrogenic
hormones
(pharmaceuticals)
17 alpha-
ethinylestradiol (EE2)
Large (83%) Large (94%)
Some reduction (10%
- ≤30%)
Relatively
large
17 beta-estradiol (E2) Medium (54%) Medium (58%) Medium
Estrone (E1) Medium (65%) Large (69%) Medium
Macrolide Azithromycin Medium (54%) Medium (54%) Significant reduction Medium
87
Based on data from JRC substance dossiers submitted to the SCHEER, supplemented by data from JRC
Pathway 1 (data rich)
No. of MS providing
monitoring data (last 10
years)
Pathway 2 (data poor)
No. of MS providing
monitoring data (last 10
years)
Estrone (E1) 26 Ibuprofen 8
17-Beta estradiol (E2) 24 Nicosulfuron 7
Ethinyl estradiol (EE2) 18 Bifenthrin 2
Diclofenac 26 Deltamethrin 4
Azithromycin 24 Permethrin 5
Clarithromycin 25 Esfenvalerate 4
Erythromycin 25 Glyphosate 13
Carbamazepine 15 Triclosan 10
Acetamiprid 22 PFAS 6
Clothianidin 22 Silver 9
Imidacloprid 25
Thiacloprid 24
Thiamethoxam 21
Bisphenol A 15
138
Substance
category
Substance
Current Distance to Target87
Expected emission
change (Dynamic
Baseline)
Overall
expected
Distance to
Target
Scale
% of MS with
exceedances
against total no. of
MS providing
monitoring data
Magnitude
% of MS with
mean monitored
concentration
>30% of
recommended
EQS
antibiotics
(pharmaceuticals)
Clarithromycin Small (16%) Small (32%) (30% - ≤50%) Small
Erythromycin Small (4%) Small (4%) Small
Other
pharmaceuticals
Diclofenac Large (80%) Large (84%)
Some reduction (10%
- ≤30%)
Relatively
large
Carbamazepine Large (100%) Large (100%)
Relatively
large
Ibuprofen Small (26%) Medium (40%)
No change (≤10%)
Medium
Triclosan
Large (100%)
(very small data-
set)
Medium (40%) Medium
Neonicotinoid
pesticides
Acetamiprid Medium (36%) Medium (36%)
Some reduction (10%
- ≤30%)
Small
Clothianidin
Medium88
(41%)
to small (12%)
Small (18%) Small
Imidacloprid Medium (64%) Large (72%) Medium
Thiacloprid
Medium (58%)89
to Small (29%)
Small (29%) Small
Thiamethoxam Small (14%) Small (19%) Small
Pyrethroid
pesticides
Bifenthrin Large (100%) (very small data-set)
Some reduction (10%
- ≤30%)
Relatively
large
Deltamethrin Large (100%) (very small data-set)
Relatively
large
Esfenvalerate Large (100%) (very small data-set)
Relatively
large
Permethrin Large (100%) (very small data-set)
Relatively
large
Other pesticides
Glyphosate Large (92%) Large (92%) No change (≤10%)
Relatively
large
Nicosulfuron
Large (71%)90
to
Medium (40%)
Medium (40%)
Some reduction (10%
- ≤30%)
Medium
Industrial
chemicals
PFAS Large (100%) (very small data-set)
Significant reduction
(30% - ≤50%)
Relatively
large
Bisphenol A Large (100%) (very small data-set)
Some reduction (10%
- ≤30%)
Relatively
large
Metals Silver
Large (89%91
) to medium (40%) (very
small data-set)
Some reduction (10%
- ≤30%)
Medium
2.2. Substances considered for EQS amendment
88
Data used for the scientific dossier on Clothianidin, jointly prepared by the JRC and the WG Chemicals, based on a data set of more than
12000 samples from 22 Member States, showed exceedances corresponding to 41% of the samples
89
Data used for the scientific dossier on Thiacloprid, jointly prepared by the JRC and the WG Chemicals, based on a data set of more than
15000 samples from 24 Member States, showed exceedances corresponding to 58% of the samples
90
Data used for the scientific dossier on Nicosulfuron, jointly prepared by the JRC and the WG Chemicals, based on a data set from
Member States, showed exceedances corresponding to 71% of the samples
91
Data used for the scientific dossier on Silver, jointly prepared by the JRC and the WG Chemicals, based on a data set of more than 11000
samples from 24 Member States, showed exceedances corresponding to 89% of the samples.
139
The assessment for the amended EQS has largely been completed using a combined
quantitative and qualitative approach. Quantitative monitoring data were used where
available and supplemented by data from the EEA dashboards providing details around the
current rate of exceedances for named substances, based on number of water bodies and MS
(noting that a total of 137,000 surface water bodies are identified in the EEA data). Data from
the EQS dossiers (where available) include data from monitoring samples from a large
number of Member States allowing the calculations of exceedance rates. In communication
with the Joint Research Centre, a two-stage process has been followed. Firstly, the data from
the EEA dashboard for the number of waterbodies with exceedance and number of MS states
with an exceedance has been used to assess the magnitude and scale of the issue in order to
assign an existing ‘size of the problem’ (see Table A11.2 in Annex 11).
Then as a second step based on the proposed EQS (where available) and guidance from the
JRC, an assessment has been made as to whether the size of the gap would be worse, better,
or the same following amendment of the EQS. Combined with the expected changes due to
dynamic baseline, an overall distance to target has been determined, as shown in Table A4.6.
Table A4.6: Summary of the distance to target assessment for existing PS substances considered for EQS
amendment
Substance
category
Substance
Current Distance to
Target 92
Change in
distance to
target due
to new
EQS
Expected emission
change (Dynamic
Baseline)
Overall
expected
Distance to
Target
Scale Magnitude
Pesticides
Chlorpyrifos Medium Small Increase
Some reduction
(10% - ≤30%)
Medium
Cypermethrin Medium
(assumed)
Medium
(assumed)
Increase Medium
Diuron Medium Small Increase Medium
Heptachlor and
Heptachlor epoxide
Small
(assumed)
Small
(assumed)
Decrease
No change (≤10%)
Small
Hexachlorobenzene Medium Small Decrease Small
Tributyltin
Large Medium Increase
Some reduction
(10% - ≤30%)
Medium
Industrial
chemicals
Dioxins and furans Medium
(assumed)
Medium
(assumed)
Increase
No change (≤10%)
Medium
Fluoranthene Medium Medium Decrease Small
Hexachlorobutadiene Medium Small Increase Small
Nonylphenol Medium Small Increase
Some reduction
(10% - ≤30%)
Small
PAHs Large Medium Increase Medium
PBDEs
Medium Large Increase
Relatively
large
Metals
Mercury
Large Large Increase
Significant
reduction (30% -
≤50%)
Relatively
large
Nickel
Large Medium Increase
Some reduction
(10% - ≤30%)
Relatively
large
2.3. Role of the ‘One-Out-All-Out’ approach
92
Based on data from JRC substance dossiers submitted to the SCHEER
140
Despite the observation that the estimated ‘gap size’ for an individual pollutant can vary from
relatively large, medium or small, this is only a rough and indicative approach with a wide
range of limitations. The ‘one-out-all-out’ (OOAO) principle that is embedded in the WFD,
means that a WB can only achieve good status if this status is achieved for all pollutants. In
other words, if the water does not achieve good status for one or more of the existing
pollutants included in the assessment of the chemical status, the addition of a new PS does
not make a difference. The current list of PS under the EQSD contains 53 priority
(hazardous) substances. So only if a WB achieves good status for all those 53 pollutants,
which is the case only for 38% of all WBs, the addition of a single new PS/PHS could make a
difference between pass / fail. Thus, in the theoretical situation where 100% of the WBs in all
MS would fail to achieve good status based on this single pollutant, the maximum
contribution to the chance for a WB to fail to achieve good status could be 1.9% (1/53 *
100%), based on a significant exceedance of the EQS for this new PS/PHS. To estimate the
likely indicative contribution of adding a single substance to the PS list, the maximum 1.9%
must first be multiplied by 38% (the no. of WBs currently achieving good status) and
subsequently also with the average of the size of the predicted exceedances (16.5% for the
‘small’ category; 49.5% for the ‘medium’ category; and 83% for the ‘large’ category). This
would result in the following maximum contribution to the chance to fail for a single
substance added:
 Small: 1.9% *16.5% *38%= 0.14% indicative contribution per substance
 Medium: 1.9% *49.5% *38% = 0.36% indicative contribution per substance
 Large: 1.9% *83% *38% = 0.59% indicative contribution per substance
Multiplying the obtained values with the number of polluting substances under each distance
to target category mentioned in Tables A4.5 and A4.7 results in the overall cumulative
contribution of the new and revised EQSs to the chance to fail to achieve good status of
14.44%:
 Small: 13 (no. of new and existing substances in small category) *0.14% = 1.82%
indicative estimation of the additional contribution to failure to reach good status
 Medium: 12 (no. of new and existing substances in medium category) *0.36% = 4.32%
indicative estimation of the additional contribution to the gap size
 Large: 13 (no. of new and existing substances in large category) *0.59% = 7.67%
indicative estimation of the additional contribution to the gap size
Although this estimate cannot be directly translated into the efforts required by each
individual Member State, it provides a good indication of the ‘worst-case’ additional good
chemical status failures. In more concrete terms, this means that there is a 14.44% chance
exceedances of the new and amended EQSs cause failure to achieve good chemical status in
any surface water body.
Microplastics are excluded from these calculations at this stage since they can only be added
to the PS list after monitoring results, obtained following the development and
implementation of the proposed harmonised EU methodology, have become available.
2.4. Groundwater
The lack a Europe-wide risk assessment based on monitoring data for the LFR pollutants
means that an estimation of the likely current day status of GWBs in relation to PFAS,
pharmaceuticals and nrMs is needed to understand how the problem would evolve. To
estimate the proportion of the circa 13,746 GWBs reported on by the EU27 which are
141
potentially at risk of being at poor status due to these pollutants, the following assumptions
were made:
 The majority of MS will set a TVs based on the current day Drinking Water Standard
(DWS) as this is the most commonly used criteria for TV setting. Although there are
EQS for PFAS (PFOA and PFOS), pharmaceuticals and pesticide metabolites, this is
less likely to be used unless the GWB supports an aquatic ecosystem.
 The most likely used chemical status test would be the General Chemical Assessment
(GCA)93
test (the remaining tests are not relevant or would need more detailed
datasets).
Criteria shown in Table A4.7 were developed to assess the ‘distance to target’ for
groundwater options. The emissions, pathways and detection in groundwater were used to
estimate the scale of pollution and whether this would trigger a failure of the General
Chemical Assessment (GCA) test. Estimates were benchmarked by comparison to the
number of GWBs at risk for substances with similar emissions, pathways and environmental
fate which are listed in the GWD Annexes or lead to poor status of GWBs.
Table A4.7: Criteria for the distance to target assessment for groundwater options
Size of gap Criteria for scale of distance to target
Small
Scale: Predicted GWB failure in ≤33% of MS reporting data (based on baseline impact and
difference between GWQS and use of DWS)
Magnitude: Extrapolation of GW WL results – 0-33% of monitoring points in the GW WL
exceed the GWQS (or DWS if option is for an Annex II listing)
Medium
Scale: Predicted exceedances 33% to 66% of MS reporting data (based on baseline impact
and difference between GWQS and current day use of DWS)
Magnitude: Extrapolation of GW WL results – where 33-66% of monitoring points in the
GW WL would exceed the GWQS (or DWS if option is for an Annex II listing)
Large
Scale: Predicted exceedances in over 66% of MS reporting data (based on baseline impact
and difference between GWQS and current day use of DWS)
Magnitude: Extrapolation of GW WL results – where 66% to 100% monitoring points in the
GW WL would exceed the GWQS (or DWS if option is for an Annex II listing)
Note that the likely time for changes in observed pollutant levels in groundwater is strongly
controlled by the lag (residence) time in aquifers. Most shallow, rapid recharge aquifers have
a residence time of between 10-30 years (e.g. gravel aquifers linked to river systems), whilst
deeper, thicker, more consolidated aquifers can have residence times of 10 to 100 years. For
some of the LFR substances which are already banned or whose use is restricted (PFOA,
PFOS and the parent products of some nrMs), concentrations may already start decreasing in
groundwater, whilst for others like pharmaceuticals they are increasing. To avoid further
deterioration of the quality and to reduce the level of purification treatment required in the
production of drinking water, setting quality standards remains essential.
93
The general chemical assessment (GCA) identifies significant pollution and requires that the pollutant(s) must be present at sufficient
number of monitoring points to indicate either that the entire GWB is at risk (average concentrations exceed GWQS or TV) or that a
significant proportion of the GWB is at risk (defined in CIS Guidance 18 as 20% or more of the area of a GWB).
142
Table A4.8: Summary of the distance to target assessment for groundwater options
Substance
group
Policy Option
Current Distance to Target
Impact of change
in emissions &
aquifer lag time
Overall
expected
Distance to
Target
Scale
% of reporting
MS with
predicted
exceedances
Magnitude
% of
monitoring
points with
predicted
exceedances
Options included in the main report
PFAS
Option 1 (Annex I - list of
24 with PFOA-equivalent
4.4 ng/l GW QS)
Large (90%) Large (68%) 30% - ≤50%
reduction due to
dynamic baseline,
but long aquifer lag
times limit short- &
medium-term
impact.
Large
Option 2 (Annex I - sum of
all at 0.5 µg/l GW QS)
Large (70%) Large (75%) Large
Option 3 (Annex II -
assuming TVs set using
DWS)
Medium
(35%)
Large
(2.5%)*
Large
Pharma-
ceuticals
Option 1 (Annex I -
Carbamazepine at 0.1 µg/l,
Sulfamethoxazole at 0.5
µg/l GW QS)
Small (37%
and 12.5%,
respectively)
Small (8%
and 0.43%,
respectively)
10% - ≤30%
reduction due to
dynamic baseline
Small
Option 2 (Annex I - group
at 0.5 µg/l)
Medium
(47%)
Medium
(50%)
Medium
Option 3 (Annex II - group,
considering Primidone;
assuming TVs set using
DWS)
Small (17%) Small (1%) Small
Non-relevant
metabolites of
pesticides
(nrMs)
Option 1 (Annex I - all
individually at 0.1 µg/l GW
QS)
Large (93%)
Medium
(59%)
10% - ≤30%
reduction due to
dynamic baseline
Large
Option 2 (Annex I - group
of all at 10 µg/l GW QS)
Large (87%) Small (6%) Medium
Option 3 (Annex II -
assuming TVs set using
DWS)
Medium
(40%)
Small (2%)* Medium
Other options considered
PFAS
List of 10 PFAS identified
by the GW WL in Annex I
at 0.1 µg/l GW QS
Large (70%) Large (75%)
30% - ≤50%
reduction due to
dynamic baseline,
but long aquifer lag
times limit short- &
medium-term
impact.
Large
nrMs
List of 16 nrMs identified
by the GW WL individually
at 1 µg/l GW QS
Large (80%) Small (29%)
10% - ≤30%
reduction due to
dynamic baseline
Medium
List of 16 nrMs identified
by the GW WL individually
at 0.1 µg/l GW QS
Large (93%)
Medium
(59%)
Large
*Magnitude is represented by % of groundwater bodies failing based on proxy substance.
2.4.1. PFAS
European emissions
PFAS are manufactured in a small number of locations in Europe and although they will be
present at these manufacturing sites, their specific manufacture in the EU is restricted through
the Stockholm Convention on persistent organic pollutants (POPs). As concern has risen
around human health impacts, the use of some PFAS compounds has been restricted or
143
banned. POPs Regulation (2019/1021/EU) implements the Stockholm Convention on POPs
and bans/restricts the manufacturing, marketing and use of POPs in the EU (applicable to
PFOS, PFOA, PFHxS). PFOS and PFOA are listed under Annex A (full ban) and so are
restricted globally and PFHxS has also been approved for listing under Annex A. Several
PFAS (incl. PFOA, PFECA and ADONA) are not permitted for use in food contact materials
under the Food Contact Materials Legislation (EC1935/2004) and Commission Regulation
(10/2011) on plastic materials and articles intended to come into contact with food.
Therefore, the production or import within the EU of several PFAS on the LFR is currently
restricted or banned. However, as PFAS are persistent they will continue to be in circulation
in products and further releases to the environment will take place and the main source is
likely to already be in the environment. PFAS will also be present within many
environmental media where they can migrate into groundwater within recharge.
Pathways to groundwater
The widespread use of PFAS in domestic and industrial settings leads to entry to groundwater
via many pathways including:
 direct emissions to ground (biosolid (including anaerobic digestate) and paper /
industrial process sludge spreading to agricultural land, landfill disposal, sewage
effluent discharges to ground);
 diffuse emissions from use of PFAS products (ski wax, personal care products,
waterproof clothing, food packaging etc.) and aerial deposition of particulates
leaching to groundwater;
 unintended emissions (fire-fighting foams, industrial use such as in chrome plating);
and
 leakage from surface water (wastewater effluent discharges or aerial deposition).
To date large scale groundwater pollution requiring remediation has been identified as due to
the use of fire-fighting foams at airfields and fire training stations, and from landfill waste
from industries using PFAS.
Emissions via soils have been shown to lead to shorter chain PFAS reaching groundwater as
longer chain substances are absorbed by soil particles until the absorption capacity is
exhausted, after which also the longer chain substances will reach groundwater. This leads to
longer lag-times for detection in groundwater and means that it is a matter of time until PFAS
substances that are already found in surface water will appear in groundwater through both
natural and artificial aquifer recharge. The persistent nature of PFAS and long residence time
in some aquifers means that they are key groundwater pollutants already, or likely to become
key groundwater pollutants in the future.
Predicted current day risk and GWB status
To estimate the number of GWBs potentially at risk of being at poor status due to PFAS
pollution it was assumed that the majority of MS would set a TV for PFAS based on the
current day DWS (i.e. sum of 20 PFAS with a limit of 0.1 µg/l).
For PFAS the there is no direct comparison with the existing Annex I substances or the
minimum list of substances listed in Annex II of the GWD. The only substances which may
behave in a similar manner are the chlorinated solvents (tetra- and trichloroethene) in that
they are persistent and mobile organic pollutants. However, the main sources for chlorinated
solvents in groundwater are leaks and spills at industrial sites and dry cleaners, rather than
144
chronic emissions through sewage disposal or airfields. Additionally, the diffuse sources of
PFAS (land spreading, aerial deposition) will not be matched. Therefore, PFAS pollution
could follow patterns similar to these chlorinated solvents but may be as widespread as
pesticide pollution (land spreading of man-made chemicals) due to the wide range of source
terms and pathways to groundwater.
Based on the large number of sources, pathways to groundwater, plus known persistence and
the reported detection by 40% of MS at around 25% of monitoring points (for PFOA)
provided for the GW WL, it is likely that PFAS will lead to a number of failures of the GCA
test. An estimate of the likely number could sit close to the impact of pesticides, i.e. 2.5% of
GWBs with 38%. However, this assumes that all MS would set TVs for PFAS under Annex
II, and therefore under the current GWD, the picture for PFAS could be closer to that for
Tetrachloroethylene (0.9% GWBs at poor status and 35% of MS reporting a problem).
Table A4.9: Benchmarking for PFAS GWB current day risk and status.
Substance leading
to RBC2 GWB
failure
GWBs
failing (No.)
MS
reporting
failures (No.)
Characteristics of pollutant Relevance to PFAS
Nitrate 8.2% (1137) 96% (25)
Emissions: widespread agricultural
use and human wastewater, and is
naturally occurring (organic matter
breakdown).
Pathway: persistent
GWQS – human health based
(relatively high compared to man-
made chemicals)
Gives a worst case for
any new listed substance
(based on current
knowledge) due to
widespread use and
persistent behaviour.
PFAS likely to have a
lower impact on GWBs
due to relatively smaller
area of emissions.
Total Pesticides
(including
metabolites)
2.5% (341) 38% (10)
Emissions: widely used in
agriculture sector but also in
amenity use
Pathway: some legacy pesticides
can be persistent, permitted
substances typically have low
persistence in soils but once in
groundwater can persist.
Similar scale of
emissions / group of
chemicals but with
different characteristics
and pathways to
groundwater.
Tetrachloroethylene
(PCE) 0.9% (123) 35% (9)
Emissions: An industrial chemical,
widely used in the past for
engineering / manufacturing works
/ dry cleaning, typically linked to
point sources
Pathway: persistent in aerobic
groundwater systems
Relevance due to
industrial source, but
PCE does not have as
many pathways to the
environment as it is not
expected to be in
domestic wastewater /
sludge.
2.4.2. Pharmaceuticals
European emissions
Carbamazepine is an anticonvulsant medication used primarily in the treatment of epilepsy
and neuropathic pain caused by diabetes/condition called trigeminal neuralia. It may also be
used to treat bipolar disorder. There are several suppliers /manufacturers and exporters in the
EU including in Germany, Poland and Portugal. The route of administration appears to be
oral only in the form of tablets and by prescription only. It is also less used as a veterinary
medicine to treat seizures (epilepsy), chronic pain (primarily nerve pain), to treat aggression,
to treat head shaking in horses although its use has decreased94
. The number of people with
epilepsy in the EU (6 million95
) is likely to far outweigh the number of horses with
94
Carbamazepine | VCA Animal Hospitals (vcahospitals.com)
95
euro_report.pdf (who.int)
145
headshaking (circa 5 million tame horses in the EU of which 1% (107) are estimated to have
photic head shaking symptoms i.e. 50,000 cases). Therefore the main emission route will be
through human prescribed use.
Sulfamethoxazole is an antibiotic used to treat bacterial infections such as urinary tract
infections, bronchitis, and prostatitis. As a veterinary medicine it is commonly used as an
antibiotic in combination as Sulfamethoxazole/Trimethoprim. It is used for cats, dogs, birds,
reptiles, and small mammals to treat certain infections such as bladder and prostate
infections, Nocardia infections, or parasitic infections. It has been used prophylactically in
livestock to prevent infections in herds and subsequently detected in manures and their
anaerobic digestates which are spread to land, potentially resulting in increased antimicrobial
resistance of soils (108). The introduction of restrictions in 2019 on prophylactic use of
veterinary medicines in livestock husbandry is likely to reduce this later source term. One
manufacturer of sulfamethoxazole is identified in the EU (Italy).
Pathways to groundwater
The European Union Strategic Approach to Pharmaceuticals in the Environment identifies
that the largest source of pharmaceuticals entering the environment is through their use. The
main pathways to groundwater will therefore differ depending upon whether human or
veterinary use is involved. It also states that “the chemical and/or metabolic stability of some
pharmaceuticals means that up to 90% of the active ingredient is excreted (or washed off) in
its original form. Wastewater treatment varies in its ability to eliminate pharmaceutical
residues96
, depending upon the substance and the level of treatment; in some cases,
substantial amounts are removed, in others, only a small percentage; but even the best, most
expensive, current treatments are not 100% effective. The release of veterinary medicines to
the environment tends to come from untreated diffuse sources such as the spreading of
manure.”
The main routes for all pharmaceuticals to groundwater are through sewage effluent
discharge (including excreted pharmaceuticals and unused products disposed of to the sewage
system despite the existence of collection schemes) and spreading of animal manure. Other
pathways include:
 the discharge of effluent from manufacturing plants;
 the spreading of sewage sludge containing pharmaceuticals removed from waste water;
 grazing livestock and spreading of manures / digestates to land;
 the treatment of pets with run-off from excreta or washed off topical applications;
 improper disposal into landfill of unused pharmaceuticals and contaminated waste;
 recharge from surface water containing pharmaceuticals from wastewater discharge.
Predicted current day risk and GWB status
Pharmaceutical pathways to groundwater are mainly limited to wastewater streams and the
spreading of animal manures and biosolids derived from the wastewater treatment regime.
Depending on their individual properties, these substances may preferentially partition into
the solid or liquid phases (i.e. be retained in sewage sludge and biosolids or the effluent
(109)). The pathway from land spreading of biosolids and manures is likely to provide a
96
Metabolites (conversion products) may have lower biological activity (see case studies in http://ec.europa.eu/health/human-
use/environment-medicines/index_en.htm) but may, e.g. if conjugated, be converted back to the parent pharmaceutical during sewage
treatment, or have similar biological activity.
146
diffuse source of pollution to groundwater, whilst wastewater discharges to ground or surface
water are more likely to provide point sources of pollution. Following the benchmarking
approach, pharmaceuticals could be compared to current day GWB status of parameters such
as boron, ammonium or phosphate which are indicators or sewage and listed on Annex II,
although the latter two will have a number of other sources (Table A4.10). Based on this
assessment the probable number of GWBs at poor status and MS reporting failures due to
pharmaceuticals is likely to be low: probably less than 1% of GWBs and perhaps up to 10%
of MS reporting a failure.
Table A4.10 Benchmarking for GWB status due to pharmaceuticals
Substance
leading to
RBMP2
GWB failure
GWBs
failing
(No.)
MS
reporting
failures
(No.)
Characteristics of pollutant Relevance to Pharmaceuticals
Ammonium
1.9%
(265) 58% (15)
Emissions: Indicator of sewage,
contaminated land and denitrification of
nitrate (latter may be natural
background)
Pathway: rapidly transformed to nitrate
in aerobic conditions so failure of
GWBs suggests large source term or
anaerobic conditions.
An indicator of sewage and
animal manure inputs, but has a
higher DWS (100 times).
Probably overstates
pharmaceutical status as
ammonium is linked to most
landfills, and to some
contaminated land sites.
Boron
0.12%
(17) 8% (2)
Emissions: naturally occurring but also
an indicator of domestic sewage
Boron occurs naturally).
An indicator of sewage but biased
to only 2 MS and has a much
higher DWS
Phosphate 0.2% (33) 19% (5)
Emissions: use in agricultural and high
levels in wastewater discharges
Pathway: could demonstrate surface
water pathway connection
An indicator of sewage but biased
to only 5 MS. No DWS.
2.4.3. Non-relevant metabolites of pesticides (nrMs)
European emissions
Non-relevant metabolites from pesticides (nrMs) are not manufactured products, forming in
the water environment through degradation of a parent pesticide compound. The pathway to
groundwater is depends on the use / release of the parent compound. The predominant parent
compound use is for plant protection by the agricultural sector as herbicides or fungicides,
but may include amenity purposes and as a biocide. The parent compounds Tolylfluanid and
Dichlofluanid are fungicides that are registered as biocides. N,N-Dimethylsulfamid (DMS)
and Chlortalonil-SA are also fungicides. The majority of parent compounds are not approved
for use in the EU. Whilst the source term for nrMs is most likely to be diffuse from the
leaching of the parent product, point sources of nrMs will also occur from leakages around
pesticide handling areas (equipment washing) and accidental spills or illegal storage of
banned parent substances.
The SANCO guidance (45) sets out a five step process for assessment of the relevance of
metabolites, ending with a refined risk assessment for substances in groundwater identified as
nrMs. The guidance is designed for use by organisations applying for authorisation of
substances under EC 1107/20997
(the plant protection products regulations) and building a
body of evidence which will then be reviewed by rapporteur MS and EFSA. New
authorisations of substances listed under EC 1107/209 are valid for 10 years, whilst renewed
97
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.
147
authorisations can be granted for up to 15 years. The review of authorised substances is
expected to include new data / modelling. For the parent compounds of LFR nrMs not
approved for use in the EU the presence of their metabolites is likely to be related to
historical use leading to a legacy issue, although illegal use cannot be ruled out. Some of the
parent compounds have not been authorised for use for many years, such as atrazine,
indicating the persistence of the nrM and / or the parent compound.
Pathways to groundwater
The main pathway to groundwater for nrMs is mainly the leaching from soils following use
of parent pesticides and transport downwards in recharging water to groundwater either as the
parent compound or as the metabolite.
Predicted current day risk and GWB status
Given the source of nrMs, the obvious worst case scenario for the likely current day impact
on GWB status would be the number of GWB that fail due to pesticide pollution. As the TVs
that would be set at the current day are unlikely to be lower than the pesticide GW QS (based
on reported TVs used by MS for nrMs) the number of reported fails is likely to be smaller
than for total pesticides or the individual parent substance (Table A4.11), especially as some
failures for pesticides are likely to be for substances without nrMs on the LFR. The estimated
impact on current day status is likely to be between 0.5% and 2% of GWBs with up to 40%
of MS reporting a failure.
Table A4.11: Benchmarking for GWB status due to nrMs of pesticides
Substance leading to
RBC2 GWB failure
No.
GWBs
failing
No. MS
reporti
ng
failures
Characteristics of pollutant
Relevance to
nrMs
Total Pesticides
(including metabolites)
2.5%
(341)
38%
(10)
Emissions: widely used in agriculture sector but
also in amenity use.
Pathway: some legacy pesticides can be
persistent, permitted substances typically have
low persistence in soils but once in groundwater
can persist.
Includes the
parent
products so
could provide
worst case.
Alachlor 4% (1)
Parent products or relevant metabolites of LFR
nrMs.
Includes the
parent
products and
some
metabolites so
could provide
a reasonable
worst case
impact.
Alachlor ESA 0.5% (63) 4% (1)
Alachlor OA 4% (1)
Atrazine 0.4% (55) 27% (7)
Chloridazon 4% (1)
Deisopropyldeethylatraz
ine
0.1% (12) 8% (2)
Desethylatrazine 0.5% (69) 19% (5)
Desisopropylatrazine
Glyphosate 8% (2)
Metazachlor ESA 0.4% (58) 4% (1)
Metolachlor 0.1% (14) 12% (3)
Metolachlor ESA 12% (3)
3. Cost-benefit analysis
Since the options do not specify the exact measures to be taken to attain the set quality
standard, the assessment of the potential costs and benefits of measures themselves (as
compared with the costs and benefits of additional guidance or monitoring) can only be based
148
on the potential measures that might be taken at EU or MS level as a result of the proposal. In
addition, realisation of some of the benefits would be in the long-term. Benefits to health are
extremely difficult to quantify, being dependent on many factors in addition to exposure and
intrinsic hazard of the substances themsleves.
3.1. Identification of possible measures and impacted stakeholders
Completion of this part of the impact assessment has utilised in part the steps outlined within
the Better Regulation Toolbox #16. This involves developing a (dynamic) baseline (for
means of comparison), compiling a wide range of policy options (and underlying practical
measures), screening of policy options (e.g. addition, amendment) and associated measures
and then detailed analysis of the associated impacts of the screened set. On that basis the
following steps have been undertaken.
Step 1 – Measures identification
The first step in the process was to identify all possible measures associated with different
policy options (addition, amendment). This was treated as a ‘blue skies’ approach with no
measure excluded from the assessment. For each substance (included under additions and
amendments) based on the profile developed (including manufacture, use, and pathway to
environment) all possible measures were identified that could intervene at all stages of the
life-cycle to help achieve good chemical status. The measures identified included technical
options such as restrictions and bans on usage, other options to limit emissions of all groups
of substances and/or abatement and wastewater treatment. Additionally, for persistent
chemicals or chemicals already banned presenting legacy issues, measures were considered
that could be applied directly to the natural environment as a means of intervention to achieve
good chemical status (e.g. contaminated site remediation).
Step 2 – Screening
Following the development of the ‘long list’ under step 1 a screening round was applied,
largely using expert judgement, but again drawing upon the criteria listed under the Better
Regulation Toolbox #16 (see pp114 and 115 of the toolbox). The measures were assessed
based on technical, economic, and legal feasibility, and societal acceptance. For some
substances a total ban might be highly effective, but if the economic costs and societal impact
would be disproportionate, this would affect the suitability score of the option. In this process
a number of options were screened out. This resulted in a shorter list of measures that could
be practically employed to help achieving good chemical status.
Step 3 – Identification of impacted sectors
Based on the preceding steps, using the screened list of measures, the key sectors likely to be
impacted by the costs of implementing the measures from step 2 were identified.
Table A4.12 provides a high-level matrix of the screened measures for the substances
(grouped into pharmaceuticals, pesticides/biocides, industrial chemicals, and metals) side by
side. This should help illustrate where the same measure could be used for multiple
substances in a complimentary fashion. Very broadly the measures identified can be grouped
into one of four overarching categories:
 Source control. This means intervention at the point of manufacture and/or use. It
can include technical measures such as improved abatement, on-site treatment, or
149
other forms of emission control. It can also relate to policy measures such as
restrictions/bans, or encouragement for substitution to safer alternatives.
 Pathway disruption. This category relates to barriers in the environment that prevent
egress to surface water, which are largely covered by technical options such as buffer
strips, constructed wetlands, amendment of combined sewer overflows (CSOs) etc.
 End of pipe options. This category relates to treatment at the waste phase, again,
largely using technical options such as quaternary technologies for wastewater
treatment, and improved landfill leachate capture systems etc.
 Monitoring and natural attenuation. The final category relates to a limited set of
substances with long lasting legacy impacts, where the best option may be natural
attenuation. This is on the basis that dredging is high cost and can potentially make
water concentrations worse.
Table A4.12: Possible policy measures to identify and subsequently limit emissions of PS and PHS
respectively to identify costs and benefits (the possible burden).
Type Pharmaceuticals Pesticides Industrial Chemicals Metals
Industry Manufacture Manufacture Mining
Agriculture - farmyard
animals/ meat
producing – natural/
drug use
Pesticides - Agriculture -
fruits & veg/ grains/
potatoes and legumes/
professional greenhouses
Manufacturing - Primary Manufacture -
smelting / remelting
Agriculture - Equines –
natural/ drug use
Pesticides - Agriculture -
Emergency authorisations
Manufacturing - Poly
carbonate
Power generation -
coal
Veterinary - domestic Pesticides - Amenity uses
(e.g., parks, pavements,
etc)
Manufacturing - epoxy
resins, paints, and
polishes
Electronics -
soldering
Hospital applications Biocides - veterinary -
agricultural uses (e.g.
sheep)
Adhesives and
sealants
Wastewater treatment
works
Biocides - veterinary -
domestic uses (e.g. cats
and dogs)
Manufacturing Biocidal products -
solids
Energy from waste
(incineration)
Biocides – professional –
outdoor/ indoor/ directly
to timer applications
Fire-fighting Biocidal
applications -
liquids
Biocides – amateur –
outdoor/indoor/directly to
timer applications
Textiles, furniture Textile applications
- incl. jewellery
Wastewater treatment
works
Paper and cardboard -
food packaging
Lubricants and
greases
Construction Pharmaceutical
manufacture
Automotive Wastewater
treatment works
Electronics - incl. cabling
Personal care products
Plant protection products
Aviation
Medical applications
Water distribution - pipes
Wastewater treatment
works
150
Type Pharmaceuticals Pesticides Industrial Chemicals Metals
Social Health impacts: Food related impacts: Loss of consumer
items/articles
Loss of consumer
items/articles
i) quality of life effects
(loss of medication/ less
effective medication)
i) loss of crop yields Choice of consumer
items/articles
Choice of consumer
items/articles
ii) loss of life ii) food security issues Infrastructure - range of
issues
Infrastructure -
adhesives, sealants,
lubricants, greases
iii) food pricing issues Petroleum industry -
safety - firefighting
Potential health
impacts from loss of
biocidal
applications
Additional pressures on
health services
Infrastructure - timber Impacts for social and
health care where PFAS is
used
Agri/horticultural
impacts - loss of
biocidal
applications
Loss of worker days to
other businesses
Pet care - health of pets Possible impacts for food
production
Alternatives - cost,
efficacy, emissions,
env. Impact
Environment Landfill Landfill Landfill Naturally occurring
Legacy sites of former
manufacture
Legacy sites of former
manufacture
Current sites of
manufacture
Landfill
Spray drift Diffuse from automotive Legacy sits of
former manufacture
Diffuse from construction
Legacy concentrations
already in water
3.2. General cost considerations
The majority of costs are economic, described below based on the relevant impacted actors,
which would include:
 To MS Competent Authorities responsible for meeting the obligations set out in the
EQSD (i.e., monitoring and analysis, reporting, development of PoMs, and overseeing
implementation of PoMs) and GWD.
 To companies, following polluter pays principles and need for greater emission
control or substitution of substances.
 To water company operators, assuming that managing some of the issues associated
with PS/PHS, Annex I and Annex II substances will fall upon water companies to an
extent (monitoring and analysis, reporting, treatment, etc.)
 To users, this would include both within industrial and professional settings. Again,
this could follow the polluter pays principle, as well as transition to alternatives/
changes in process etc.
 To consumers, assuming that there could also be the need to share the burden of costs
associated with treatment with consumers (i.e. through water bills, willingness to pay,
etc.) or through impacts associated with substitution (i.e. more expensive alternatives,
more expensive food, loss of products from the market, etc.).
3.3. Environmental benefits
151
The most significant environmental benefit from addition of candidate substances to the
EQSD list (under Option 1 (add individually), 2 (add as groups), 3 (amend existing PS/PHS),
4 (change in status), 5 (deselect)) or GWD Annex I or Annex II is that it promotes action
across the EU, in particular bilateral co-operation for MS with shared rivers and water bodies
(60% of EU waters are transboundary). The use of standardised EQS, GW QS or an approach
to derivation of quality standards at EU-level provides a foundation for MS to work
collectively towards protection of the aquatic environment. Which would mean the efforts
deployed would be more effective and efficient at managing chemical risks than MS working
in isolation.
Building upon the point above, regular monitoring of additional PS substances (under Option
1, 2, 3 and 4 in surface water and Annex I and II substances in groundwater) has the added
benefit of increased knowledge of the extent of water pollution across the EU. This allows the
assessment of the effectiveness of the measures taken under the WFD and other sectoral
legislation to limit substance emissions and trigger action if measures are insufficent; this
benefit would not be achieved under the other sectoral legislation alone. It should be noted
that monitoring of the substances in surface water option 3 and 4 already occurs, and that
EQS for them already exist, but that changes in the EQS for some of those substances could
act as a driver for continued improvement of monitoring and analytical standards and
approaches. For surface water Option 5 (deselection), data and knowledge would be lost on
these substances if removed from the PS list.
Measures employed to deal with new or amended PS and related EQS and with GWD Annex
I and Annex II substances and to further limit chemical emissions should help to improve
biodiversity (even beyond the immediate aquatic ecosystem) and thus result in a more
resilient aquatic ecosystem, enhancing its capacity to deliver ecosystem services such as the
processing of excess nutrients (Cardinale 2011). Indirectly, this will also translate into better
human health protection through a cleaner aquatic environment and cleaner drinking water.
Cleaner sediments should result in less potential for re-dissolution of pollutants in the water
column and reduced uptake of harmful substances by plants and animals.
3.4. Economic benefits
The EQSD and GWD provide a mechanism for monitoring and managing substances that
represent an EU-wide risk. The addition of substances to the PS list / Annex I list provides a
standardised level playing field with which to manage the issue. This is important for surface
water and groundwater bodies that cross political boundaries and provides impetus for
neighbouring MS to tackle issues in a consolidated fashion, which has economic benefits for
all parties.
Where a given substance/s is identified as a PS, or Annex I or Annex II substance it
promotes the need for innovative measures to address the issues presented. If the substance is
presented as an issue at EU-wide scale, there are potential economic benefits for MS
authorities, water companies, chemical manufacturers and other relevant stakeholders to pool
resources. This would equate to a cost saving compared to the same stakeholders working in
isolation at national level.
Cleaner sediment negating the need for remediation or dredging. This recognises that a
number of the candidate substances are less soluble and likely to concentrate within
suspended solids, and then within sediments and biota in the natural environment.
152
Promotion of advancements in treatment technologies and innovation within the EU to deal
with new PS and Annex I / Annex II substances.
3.5. Social and public health benefits
The following social and public health benefits have been identified:
 Additional information will be available to the public on the PS/PHS, Annex I and
Annex II substances and the quality of the aquatic environment;
 Reduced bioaccumulation of hazardous chemicals in humans, reduced exposure
(occupational and other) if less hazardous substitutes are used;
 Potential improvements in quality of fish and shellfish from commercial fisheries,
aquaculture and recreational fishing (which would confer economic benefits in
managing resources more sustainably). These improvements will also benefit the push
for a significantly increase organic aquaculture sector, and the use of less
antimicrobials in the sector98
, which is again supportive to public health and building
a sustainable food system99
.
 Improved amenity value of water bodies (tourism, angling, etc), and reduced exposure
for humans using them for bathing, surfing and other water sports;
 Cleaner water for livestock where surface water or groundwater is used directly,
resulting in reduced accumulation in meat and milk, hence reduced human exposure
to hazardous substances, likewise, less accumulation in meat, surface waters,
groundwaters and and drinking water;
 Reduced potential for accumulation of hazardous substances in crops when untreated
water is used for irrigation.
98
Strategic guidelines for a more sustainable and competitive EU aquaculture for the period 2021 to 2030” (COM(2021) 236 final
99
Farmed seafood has a comparatively low-carbon footprint in comparison to (intensive) livestock farms.
153
ANNEX 5: RELATIONS BETWEEN ONGOING INITIATIVES AND THE PRESENT INITIATIVE
Initiative
Brief description of the
initiative
Potential interactions and added value of
the preferred option
Expected impact on
this policy initiative
(specified per group of
substances)
Evaluation of
the Sewage
Sludge
Directive
This Directive regulates the use
of sludge in agriculture and
includes limit values (mainly for
heavy metals) when sewage
sludge is used in agriculture. The
Directive is under evaluation
before deciding on its possible
revision.
Measures aiming at better controlling pollution
at source notably for non-domestic pollution
will contribute to improve the quality of the
sludge, making it more suitable for agriculture.
Actions to better capture and treat storm water
overflows and urban runoff are expected to
allow capturing more micro-plastics and
increase their presence in sludge. Moving
towards energy neutrality will only happen if
more sludge is digested (production of biogas).
Evaluation of the SSD
has been excluded from
the impact (dynamic
baseline) assessment as
at the time of analysis it
was still at early stages
of the better regulation
process.
Revised
Industrial
Emission
Directive
The Industrial Emission
Directive (IED) regulates water
and air emissions from large
industrial facilities. Commission
proposal adopted on 6 April
2022.
The revised IED will contribute to better
control emissions to air and water from large
industrial facilities notably for what relates to
non-domestic pollution. The inclusion of cattle
farming under the scope of the Directive will
result in limited to weakly positive impacts on
water quality. Besides nutrients, this concerns
also veterinary pharmaceuticals. Monitoring of
substances on the PS list will help evaluate the
effectiveness of measures introduced under the
IED.
Also the revision of the lists of polluting
substances and the reporting thresholds under
the Industrial Emissions Portal Regulation
(IEPR, former E-PRTR), will include new
emerging pollutants like PFAS, which will
help to better assess the actual emissions in the
future (provided the legislator does not change
these elements)
Pharmaceuticals used
in animal farming: 10-
30% emission
reduction
Pesticides: no impact
nrMs: n/a
Silver: no impact
PFAS: 10-30%
emission reduction
BPA: 10-30% emission
reduction
Revised
Drinking Water
Directive
The Drinking Water Directive
(DWD) concerns the quality of
water intended for human
consumption. Its objective is to
protect human health from
adverse effects of any
contamination of water intended
for human consumption by
ensuring that it is wholesome
and clean. The revised DWD
was formally adopted on 16
December 2020 and entered in
force on 12 January 2021.
The recast DWD is particularly relevant to the
GW WL and LFR because it sets out drinking
water standards for a minimum list of 20
PFAS substances and commits the EC to
developing an analytical methodology for
these substances by 2024.
Measures aiming at better controlling pollution
at source will improve quality of surface and
groundwater, which in turn contributes to
lower costs of (pre)treatment as a result of
improved quality for potable water and process
water for drinking water supply.
Pharmaceuticals: no
impact
Pesticides: no impact
nrMs: 10-30% emission
reduction
Silver: no impact
PFAS: 10-30%
emission reduction
BPA: 10-30% emission
reduction
Marine Strategy
Framework
Directive
The Marine Strategy Framework
Directive (MFSD) obliges MS to
achieve Good Ecological Status
in all marine waters by 2020. It
will be revised (Commission
Proposal planned for 2023).
The MFSD GES includes (through the
‘descriptors’) reducing the presence of
contaminants in the aquatic environment,
including in seafood. Given the strong links
between the marine and the freshwater
environment, a reduction of contaminants in
either is mutually beneficial (e.g. for migrating
fish and generally in waterbodies connecting
river and sea like estuaries). Moreover, the
WFD and the MSFD overlap geographically as
the regards the first nautical mile off the coast.
N/A
154
Initiative
Brief description of the
initiative
Potential interactions and added value of
the preferred option
Expected impact on
this policy initiative
(specified per group of
substances)
Listing of substances, especially for surface
water, will lead to reduction of these
substances in the linked marine waters.
Revised Urban
Waste Water
Treatment
Directive
The UWWTD obliges collection
and treatment of waste water
from agglomerations. It is
currently under revision
(adoption planned for July 2022)
The revised UWWTD is likely to bring a range
of important improvements in the period up to
2020. The better management of storm water
overflow should reduce plastic pollution. The
increased connection of UWWTPs below
2000pe in combination with lowering the
threshold for reporting to a wastewater
treatment to 1000 inhabitant equivalent and a
stricter inspection of ‘individually appropriate
systems’ should reduce diffuse pollution of all
types and their monitoring. Specifically, to
reduce pollutants ending up in effluents
producer responsibility schemes will be set up
and advanced treatment will become
mandatory for areas at risks and in bigger
agglomerations. The resulting waste water
sludge will, as result, contain more pollutants.
Revised Directive
assessed to lead to 44%
reduction of toxic load
(which includes the
substances considered
in this initiative) of
which 64% are in areas
of risk.
Revision of the
UWWTD has been
excluded from the
impact (dynamic
baseline) assessment as
at the time of analysis it
was still at early stages
of the better regulation
process.
Proposal for
Nature
Restoration
Regulation
(NRR)
The proposal for a Nature
Restoration Regulation,
scheduled for 20 June 2022,
aims at restoring ecosystems in
the EU, including aquatic
ecosystems.
The NRR will directly contribute to increase
the green areas in the cities and therefore the
capacities of urban soils to absorb rainwater.
In case heavy rains, less ‘clean’ rainwater will
be mixed to polluted waters in the urban
collecting systems and less untreated water
will be sent to the environment. Outside cities,
the NRR will lead to more natural river and
lake systems, allowing water to be retained
longer and restoring the capacity of
ecosystems to purify water. The precise effects
on water absorption of the NRR will depend
on the very local circumstances, but both
legislations will act in a synergetic way.
In the long term (2050)
the gradual increased
restoration of
ecosystems will
increase the
purification capacity of
nature, leading to lower
emissions to water for
all substances.
Mercury
Regulation
The 2017 Mercury Regulation
prohibits the export and import
of mercury containing products
and phases out its uses
The Mercury Regulation will reduce
significantly any new emission of mercury to
water. However, mercury deposition (eg as a
result of burning coal) will continue and
mercury currently in the aquatic environment
is extremely persistent.
Significant impact on
new emissions except
those deposited through
the air; limited impact
on mercury
concentrations given
large legacy
concentrations.
Ban on all but
the essential
uses of PFAS
The Chemicals Strategy for
Sustainability announced a ban
on all but the essential uses of
PFAS. Commission proposal for
a ban on placing on the market
of PFAS expected end of 2024.
Depending on the final definition of ‘essential
use’, this should over time significantly impact
on new emissions to water. Existing products
containing PFAS will however continue to
emit PFAS over the years to come.
Significant legacy
PFAS pollution
remains, new emissions
will gradually decrease,
depending on the scope
of the PFAS ban.
Regulation on
the Sustainable
Use of Plant
Protection
Products (SUR)
A proposal for a Regulation on
the Sustainable Use of Plant
Protection Products (SUR) is
scheduled for adoption by the
Commission on 20 June 2022.
The SUR will introduce a binding target at EU
level of 50% pesticide use and risk reduction,
and require MS to set nationally appropriate
binding targets. It will also prohibit the use of
any pesticide in urban areas and vulnerable
zones under nature legislation (eg Natura 2000
sites) and water legislation (for WFD the
Achieving the 50%
reduction will only be
partially the result of
the SUR – other factors
are change of crops,
nature protection,
substitution. The SUR
155
Initiative
Brief description of the
initiative
Potential interactions and added value of
the preferred option
Expected impact on
this policy initiative
(specified per group of
substances)
drinking water protection zones). Once
implemented this should significantly reduce
especially pesticide pollution from diffuse
sources, while in urban areas it will
complement the results of the modified
UWWTD.
An improved digital data collection on use,
quantities, geographical application and
seasonal pesticides use, under the envisaged
revised Sustainable Use of Pesticides
Regulation, would provide hugely valuable
input for an improved implementation of
legislation like the WFD and the EQSD, as
well as the EU Biodiversity Strategy 2020, the
common agricultural policy (CAP), and the
Thematic Strategy on Soils.
alone will likely have a
limited negative impact
on the concentrations of
pesticides in water.
An improved data
collection on pesticide
use at farm level will
improve the data
quality on pesticides
which will not only
reduce costs related to
data assessment related
to setting future EQSs,
but also speed up the
identification of
emerging health and
environmental risks and
the revision of
standards to scientific
progress.
Veterinary
pharmaceuticals
legislation
The Veterinary Pharmaceutical
legislation regulates the placing
on the market, manufacturing,
import, export, supply,
distribution, pharmacovigilance,
control and use of veterinary
medicinal products.
The Veterinary Pharmaceutical legislation
requires an environmental risk assessment to
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. Relevant to
water, a guidance on the environmental risk
assessment of medicinal products for use in
aquaculture including, where appropriate,
recommendations for risk management
measures is being develop. Once ready, this
would promote a more prudent and responsible
use of veterinary medicines.
ERA and guidelines are
expected to lead to a
limited effect on
emissions of relevant
veterinary
pharmaceuticals,
particularly in rural
areas.
Revision of
Human
Pharmaceuticals
Legislation
The Human Pharmaceuticals
Legislation regulates the placing
on the market as well as
authorisation, supervision and
phar-macovigilance of medicinal
products for human
consumption. A Proposal for
revision is scheduled for 2022.
The Human Pharmaceuticals Legislation
requires Environmental Risks Assessment
(ERA) of pharmaceuticals to be placed on the
EU market. However such ERA are not
required for many of the pharmaceuticals
currently on the market. Requiring ERA may
not prevent active pharmaceutical ingredients
reaching the aquatic environment; they would
however provide national authorities with
information useful to manage emissions and
impacts.
Very limited impact; if
any, it will be from
increased
pharmacovigilance
following stricter
application of ERA for
relevant human
pharmaceuticals,
particularly in urban
areas.
Initiative on
micro-plastics
The Micro-plastics initiative is
expected to reduce non-
intentional micro-plastics
emissions from some sources
such as textiles and geotextiles,
tyres, plastic pellets, paints, and
detergent capsules.
With the planned initiative and in the mid-
term, lower emissions of micro-plastics from
these sectors could be expected in urban waste
waters. However even if all possible measures
are taken to reduce emissions at source, there
will always be residual emissions. Micro-
plastics are well captured in wastewater
treatment plants (between 80% up to 99%
when tertiary treatment is in place). The
Overall EU target of
30% reduction by 2030
(cf ZP Action Plan).
Mix of measures as yet
not established (impact
assessment ongoing).
156
Initiative
Brief description of the
initiative
Potential interactions and added value of
the preferred option
Expected impact on
this policy initiative
(specified per group of
substances)
proposed measures under the UWWTD will
improve the abilities of capturing more micro-
plastics in the collecting and treatment system.
The proposed monitoring of microplastics in
surface water will be complementary to this
initiative.
EU Strategy for
Plastics in a
Circular
Economy
The EU Strategy for Plastics in a
Circular Economy proposes
action along four strands: 1)
restrictions to intentional
addition of microplastics to
products via REACH, 2) actions
on unintentional release of
microplastics, 3) measures to
reduce plastic pellet spillage and
4) use of UWWTD to capture
and remove microplastics
The planned initiative support the efforts to
reduce plastics in water by developing a
methodology and a mechanism to monitor
presence of microplastics in the aquatic
environment. On the other way around, the EU
plastics strategy and its related actions will
drive down the presence of such plastics.
Thus, the two initiatives are working
complementarily.
Strategy will support
action to achieve the
30% reduction target
for microplastics by
2030 cf ZP Action Plan
Ecodesign for
Sustainable
Products
Regulation
The proposal aims to reduce the
negative life cycle
environmental impacts of
products and improve the
functioning of the internal
market via significantly
improving product circularity,
energy performance and other
environmental sustainability
aspects.
The push for product circularity under the
Ecodesign Regulation will promote reduction
and/or phase-out of some hazardous chemicals
which currently may hinder the circularity
potential of the product. This will reduce the
manufacturing and end-of-life releases of such
substances into the environment, including
water bodies.
Longer term effect on
emissions (in use and
end-of-life) of
industrial chemicals,
including PFAS.
EU Ecolabel
The updated EU Ecolabel
criteria now applies to all
cosmetic products, as defined
under the EU Cosmetic
Regulation. Previous EU
Ecolabel requirements only
covered a limited range of so-
called ‘rinse-off’ products such
as body wash, shampoo and
conditioner. The updated rules
include ‘leave-on’ cosmetics
such as creams, oils, skin-care
lotions, deodorants and anti-
perspirants, sunscreens, as well
as hairstyling and make-up
products. In the animal-care
sector, the EU Ecolabel can be
awarded to rinse-off products,
such as soaps and shower
preparations.
The new EU Ecolabel criteria for cosmetics
and animal-care products (adopted in October
2021), offers consumers across the EU the
benefit of trusted proof for genuine green
brands. The EU Ecolabel is a reliable third
party verified label of environmental
excellence, which takes into account the
environmental impact of a product throughout
its entire life-cycle, from the extraction of raw
materials to final disposal. Consequently the
uptake of the EU ecolabel for this category of
products can drive down emissions. Today,
three out of four care products sold in Europe
display an environmental claim or label, and
yet many of these claims are difficult to
understand or confusing for the consumer.
Limited positive
impact; if any, but an
increased uptake could
reduced emissions from
pharmaceuticals (e.g.
conservation agents,
substances with
endocrine disrupting
effects, microplastics
and PFAS) contained in
personal care products.
EU Strategy for
Data, the
INSPIRE
Directive, and
the Directive on
Public Access
to
Environmental
The strategy for data aims at
creating a single market for data
that will boost the Europe’s
global competitiveness and data
sovereignty. Common European
data spaces will ensure that more
data becomes available for use in
the economy and society, while
keeping the companies and
Water related data could complement and be
cross referenced with publicly available
environmental data on emissions from
industrial installations covered by the IEPR
and e.g. help monitor the effects of the
implementation of new Best Available
Techniques on the aquatic environment
surrounding such installations. This also
benefits data made available under the EU
Limited positive
impact; as data is
collected once and
reused many times,
thus generating clear
synergies and reducing
costs, while boosting
innovation in the data
economy, like e.g.
157
Initiative
Brief description of the
initiative
Potential interactions and added value of
the preferred option
Expected impact on
this policy initiative
(specified per group of
substances)
Information individuals who generate the
data in control. Data driven
applications will among others
be aimed at improving health
care, create safer and cleaner
transport systems, generate new
products and services, reduce the
costs of public services (by
reusing data multiple times) and
improve sustainability and
energy efficiency. As part of its
data strategy the Commission
has proposed a Regulation on
European data governance.
INSPIRE Directive
Clear synergies exist between this initiative,
the Zero Pollution Outlook, and the
Commission proposal for a Regulation of the
Industrial Emissions Portal (IEPR, former E-
PRTR), the. Especially, data collected under
policy options 3, 4, 6 and 7 would lead to
better water quality data in shorter than the
current 6-years intervals
close to real time
environmental
monitoring data for
authorities and citizens.
Textile Strategy
The EU strategy for sustainable
and circular textiles addresses
the production and consumption
of textiles and aims that all
textile products placed on the
EU market are durable,
repairable and recyclable, to a
great extent made of recycled
fibres, free of hazardous
substances, produced in respect
of social rights and the
environment.
The Textile Strategy will harmonise EU
Extended Producer Responsibility rules for
textiles and economic incentives to make
products more sustainable. It will also address
the unintentional release of micro-plastics
from synthetic textiles.
Effect on microplastics
and industrial
chemicals including
PFAS used in textiles
production
Liability
Directive
The Environmental Liability
Directive, currently under
revision, sets the EU framework
for environmental liability,
including compensation.
The Environmental Liability Directive could
lead to compensation for water damage caused
by pollution (including the pollutants to be
added under this initiative) from IED
installations or discharges to water in breach of
WFD
If implemented as
proposed, small
negative effect on
emissions /
abstractions.
Environmental
Crime Directive
The Environmental Crime
Directive, currently under
revision, sets the framework for
environmental crime.
The Environmental Crime Directive would, in
situations where the damage is the result of a
breach and intentional, give rise to criminal
sanctions.
If implemented as
proposed, small
negative effect on
emissions /
abstractions.
Commission
Communication
‘Strategic
guidelines for a
more
sustainable and
competitive EU
aquaculture for
the
period 2021 to
2030’
The annex to this
Communication also proposes
specific actions by the
Commission, the EU Member
States and the Aquaculture
Advisory Council to make
progress in various areas to the
make the aquaculture sector
more sustainable while ensuring
its competitiveness. The
guidelines reinforce the specific
aquaculture targets from the
Farm to Fork Strategy, in
particular the reduction of sales
of antimicrobials and a
significant increase in organic
aquaculture.
In the process of implementation of the
“Strategic guidelines for a more sustainable
and competitive EU aquaculture for the period
2021 to 2030”, the Commission plans to
develop a guidance document on
environmental performance in the aquaculture
sector. This will include, among other issues,
the mapping of good practices for the “use of
chemicals and medicines” at governmental and
industry level. In the guidelines, the
Commission highlighted the necessity to
develop solutions to reduce the use of
veterinary products and other substances (e.g.
anti-fouling agents), through, for example,
appropriate husbandry practices.
If implemented as
foreseen a small
positive effect on
emissions.
158
Initiative
Brief description of the
initiative
Potential interactions and added value of
the preferred option
Expected impact on
this policy initiative
(specified per group of
substances)
Stockholm
Convention
(POPs)
The Stockholm Convention on
Persistent Organic Pollutants
regulates POPs by either
prohibiting their presence on the
market or reducing / regulating
their use.
The EU and MS are a party to the Convention
and have to implement its decisions in the EU
/ MS
Implementation of the
Convention will drive
down emissions of
POPs. If further POPs
are added in the future,
corresponding
measures will have to
be taken by EU and
MS.
Minamata
Convention
The Minamata Convention
regulates Mercury mining,
storage and use.
The EU and MS are a party to the Convention
and have to implement its decisions in the EU
/ MS
Implementation of the
Convention will drive
down emissions of
mercury. If further uses
are regulated /
prohibited through the
Convention, EU / MS
will have to implement
this as well.
Global Plastics
Agreement
The UN Environment Assembly
agreed, in 2022, to launch
negotiations towards a globally
binding agreement on plastics
While still many years before such an
agreement will enter into force, it is likely to
have significant impacts on what plastics stay
on the market and in what quantities these will
reach the environment
Monitoring methods
and regulation of
plastics in water is
relatively new area and
this initiative may
inspire what rules are
agreed in the global
instrument.
159
ANNEX 6: TECHNICAL PROCESS FOR THE REVISION OF THE LIST OF PRIORITY
SUBSTANCES AND THEIR EQS IN SURFACE WATER
1. Introduction
The review of the list of priority substances (PS) in surface waters under the Water WFD
considered which substances should be added to the list of PS, the environmental quality
standards (EQS) that should be set for them in the EQS Directive (EQSD), the
deselection of existing PS, the revision of EQS for some others, and the designation of
priority hazardous substances (PHS). PHS are a subset of PS that are identified as being
“toxic, persistent and liable to bio-accumulate, and other substances or groups of
substances which give rise to an equivalent level of concern” (WFD article 2(29)). In this
context, the substances identified by the following processes and legislations are
relevant: Substances of Very High Concern (SVHC) under REACH, Persistent Organic
Pollutants (POPs) under the Stockholm Convention and substances identified as
Persistent, Bio-accumulative and Toxic (PBTs) under Regulation (EEC) No.793/93.
The prioritisation exercise (to identify new PS) was based on the criteria set out in the
WFD Article 16(2), and the derivation of EQS followed the 2018 Technical Guidance
Document for deriving EQS (53). Thresholds are usually set one substance at the time,
except for cases where adding substances in groups (of substances with similar effects)
has a clear added value. The multi-dimensionality of water pollutants and their effects is
addressed by the fact that for each substance, where possible, EQSs are derived for
different types of media (inland surface waters, other surface waters, and biota) and
different concentrations/ multivariate thresholds (Annual Average (AA) and Maximum
Allowable Concentration (MAC)).
2. Technical process underpinning the selection of substances
The technical work for the review was led by the Joint Research Centre (JRC) and DG
ENV, in close cooperation with subgroups of experts and members of the Working
Group (WG) Chemicals under the Common Implementation Strategy (CIS) for the WFD.
The membership of WG Chemicals consists of Commission DGs, MS and stakeholder
organisations including a range of European industry associations, NGOs and
intergovernmental organisations. The steps of the review process are described below.
2.1. Preparatory phase
During this phase data were collected (including monitoring and hazard data) and a
prioritisation process for identifying candidate PS was carried out. Figure A6.1 illustrates
the prioritisation process.
Whether a compound is “discharged in significant quantities” is commonly decided
based on the substance’s exposure level, referred to as Predicted Environmental
Concentration (PEC). This in turn is compared to an ecological safety threshold
expressed as PNEC. PEC/PNEC risk ratios above 1 would trigger the substance’s
inclusion in the routine monitoring and the derivation of a legally-binding EQS.
160
Figure A6.1: Substance selection process for surface water
Subsequently, individual draft substance dossiers for prioritised surface water
contaminants were prepared by subgroups of experts, with rapporteurs, under WG
Chemicals, and consultants contracted by the Commission. The subgroups included
experts from MS, industry actors and NGOs alike. For the prioritised substances, EQSs
were derived for individual substances or groups of substances based on the
aforementioned 2018 Technical Guidance for deriving EQS. The document provides
detailed information on criteria and issues to be considered. Those relevant to setting
EQSs are mentioned below:
 Data acquiring, evaluation, selection and quality assessment of data;
 Risk assessments to be performed, and relations with (pesticide) risk assessments
under other pieces of legislation;
 Calculations, extrapolation and expression of QSs;
 Deriving quality standards for water abstracted for drinking water;
 Standards to protect water quality;
 Derivation of standards protecting aquatic species and wildlife from (secondary)
poisoning;
 Protection of humans against adverse health effects from consuming
contaminated fisheries;
 Limitations in experimental data – use of non-testing approaches;
 Calculation of QS for substances occurring in mixtures;
 Implementation of EQSs.
161
2.2. Validation stage
During this stage the draft dossiers for the candidate PS, in particular their draft EQSs,
were reviewed/commented and validated by the MS (MS) and other members of the WG
Chemicals, and were publicly available in CIRCABC.
2.3. Independent review stage
During this stage independent scientists of the Scientific Committee on Health,
Environmental and Emerging Risks (SCHEER) reviewed the EQS in the substance
dossiers and provided an independent scientific opinion on their appropriateness.
2.4. Commenting period on the SCHEER preliminary scientific opinions
During this phase, the preliminary SCHEER opinions on the EQS derived for each
candidate PS were published for commenting during 4 weeks, allowing all stakeholders
to make additional/final comments, and in particular the submitter. These comments were
collected, discussed and addressed when relevant by the SCHEER to inform its final
scientific opinions. The final opinions are published on its website100
. For some
substance dossiers, the SCHEER is still in the process of formulating preliminary or final
opinions, and commenting periods on a few others are still ongoing. This means that the
review is still in process and that some EQSs might need to be modified to take the final
SCHEER opinions into account.
2.5. Outcome of the Prioritisation exercise
The prioritisation exercise resulted in 24 possible new PS for surface water, including
PFAS as a group. The candidate substances included in this revision process are shown
below.
Figure A6.2: Candidate substances for setting new EQSs for surface water.
2.6. Input from Surface Water Watch List monitoring
100
https://ec.europa.eu/health/scientific-committees/scientific-committee-health-environmental-and-emerging-risks-scheer/scheer-
opinions_en
162
The obligation introduced into the EQSD in 2013 to establish a surface water watch list
has so far resulted in the adoption of the following three Commission implementing
decisions establishing a watch list of substances for Union-wide monitoring in the field
of water policy (in chronological order): 2015/495/EU, 2018/840/EU and 2020/1161/EU.
Monitoring results from the 3rd
WL are not yet available, but the data collected for
substances listed in the first two Commission implementing decisions have resulted in
the following substances now being proposed for inclusion in the PS list: 17-Alpha-
ethinylestradiol (EE2); 17-Beta-estradiol (E2); Estrone (E1); Diclofenac; Macrolide
antibiotics; and Neonicotinoids (Imidacloprid, Thiacloprid, Thiamethoxam, Clothianidin,
and Acetamiprid).
3. Designation of priority hazardous substances
The review considered whether the candidate substances are SVHCs and/or POPs, and
thus whether they should be designated as PHS. For PHS, the aim is to completely phase
out emissions to the aquatic environment. Also, if a substance/ RBSP is classified a PHS
the risk is expected to be an EU-wide risk, whereas for PS the risk can be a non EU-wide
risk.
4. Amendment of EQS for existing PS, and review of status
The updated (2018) version of the Technical Guidance Document for Deriving EQS was
applied to check and revise the EQS for all existing PS, also taking into account any new
scientific findings. Based on this process, 15 substances were identified as candidates for
EQS amendment, as summarised below.
Consideration was also given to changing the status of some existing PS, with
Octylphenols being a possible candidate for designation as a PHS.
163
Figure A6.3: PS for possible revision of existing EQS for surface water.
5. Deselection of existing PS
The JRC drafted a document on criteria for the deselection of existing PS, and proposed a
list of candidates for deselection. The final version took into account comments from
members of the WG Chemicals and comments submitted by stakeholders through the
Impact Assessment consultation process. It is published in CIRCABC101
.
5.1. Criteria for deselection
As mentioned before, the potential deselection of existing PS (excluding those recently
added) was done by following the ‘deselection’ criteria listed in the document. The
agreed criteria for the deselection were extensively discussed with the experts. The JRC
started drafting the first version of deselection criteria in 2016. Briefly the main criteria
were: i) the inclusion of only banned substances, and ii) no exceedance in more than
three MS based on monitoring data available at that time, covering the period 2006-2014.
5.2. Substances proposed for deselection
Application of the criteria resulted in the proposed deselection of the following PS:
Alachlor, Chlorfenvinphos, Simazine, and Carbon-tetrachloride.
101
https://circabc.europa.eu/ui/group/9ab5926d-bed4-4322-9aa7-9964bbe8312d/library/a953a59a-b899-4b8e-9815-
0fee9006239f/details
164
ANNEX 7: TECHNICAL PROCESS FOR THE REVISION OF THE LISTS OF POLLUTANTS IN
GROUNDWATER
1. Introduction
Article 10 of Directive 2006/118/EC (review clause) requires the Commission to review
Annexes I and II of the GWD every six years. The last review led to amendment of
Annex II via Directive 2014/80/EU. Following this, the Commission introduced the first
list facilitating the review of Annexes I and II (LFR) in 2014 and published its results
(22). This LFR summarised the main output of the Voluntary Groundwater Watch List
process described in the Groundwater Watch List Concept & Methodology. In 2021,
under the umbrella of the Working Group Groundwater (WG GW), the sub-group on the
Voluntary GW Watch List was reactivated102
. The membership of both the WG GW and
GW WL sub-groups consists of Commission DGs, MS and stakeholder organisations
including a range of European industry associations, NGOs and intergovernmental
organisations.
Furthermore, Article 3(5) of the GWD requires MS to publish information on the TVs
they have established in their RBMPs. The 2014 GWD amendment updated these
detailed reporting specifications. CIS Guidance Document No. 35 (110) further specifies
how the reporting of TVs is to be operationalised (111).
CIS Guidance Document No. 18 (112) provides recommendations and considerations for
Member State administrations on how to set and use TVs. It explains the links between
TVs and the ‘prevent or limit’ objective of GWD Article 6. The document also defines
some important terminology, the scale and location of TV application, and the general
methodology for establishing them, including the different aspects of groundwater
chemical status to consider. Finally, the Guidance Document elaborates how TVs fit into
the groundwater chemical status assessment process using the five pertinent tests for
chemical groundwater status.
2. Technical process underpinning the selection of substances
The technical work for the review was led by the subgroups of experts and members of
the Working Group (WG) Groundwater under the Common Implementation Strategy
(CIS) for the WFD. The steps of the substance prioritisation process are described in
Figure A7.1 below.
102
https://circabc.europa.eu/ui/group/9ab5926d-bed4-4322-9aa7-9964bbe8312d/library/a53f1d54-0cd9-4de6-b370-
2cbb14004986?p=1&n=10&sort=name_ASC
165
Figure A7.1: Substance selection process for groundwater
The data collection was primarily focused on substances causing risk and/or failure of
good chemical status. Data were collected on MS level only; no differentiation into
RBDs or GWBs was made. Depending on availability, MS provided GQA-TVs for 2nd
RBMP (most values) or 3rd
RBMP (some values). In total 20 MS submitted data for 100
pollutants. Of these, 21 substances reported by at least 4 MS were selected for further
assessment. Although only GQA-TVs are considered, there is still a wide range in TVs.
Data provided for TVs, CVs (for drinking water and “other uses”) and NBLs as well as
complementary remarks allowed in most cases for explaining the wide range. It turned
out that wide ranges are not only caused by particularly high NBLs, but also by
particularly low NBLs. Apart from NBLs also CVs for DW substantially account for the
GQA-TVs reported. As provision of CVs was incomplete, not all TVs could be
explained.
The substances proposed for inclusion in the LFR by GW WL group, and their
corresponding quality standards were validated by the WG GW. By analogy with the SW
process, the resulting proposals for including them in the Annexes to the GWD were
independently reviewed by scientists of the Scientific Committee on Health and
Environmental Emerging Risks (SCHEER). The substances identified were:
pharmaceuticals, PFAS and degradation products of pesticides (often referred to as non-
relevant Metabolites (nrMs)), as outlined below.
166
Figure A7.2: Substances proposed for inclusion in the Annexes to the GWD.
2.1. Input from Groundwater Watch List monitoring
2.1.1. PFAS
PFAS have been detected in groundwater in many MS 103
. Data reviewed through the
GW WL process from 11 PC included only around 30 reliably reported from an initial
target list of 52 PFAS substances. Within this group, 10 PFAS substances met the criteria
for inclusion on the LFR (present in more than 10 locations in more than 4 PC). A further
three PFAS remain on the GW WL because insufficient information was identified to
justify their inclusion on the LFR. Results of the GW WL review are set out in Table
A7.1 and indicate the widespread nature of the PFAS detections.
Table A7.1: PFAS detected in groundwater in more than 4 PC and at more than 10 sites
Substance Name Acronym CAS #
No
of
PC
No. of sites
monitored
No. of sites
>LOQ
% of sites
>LOQ
PC with
detections
Status
103
Voluntary Groundwater Watch List Process Study on Per- and Poly-fluoroalkyl substances (PFAS) – Monitoring Data Collection
and Initial Analysis – Draft V.2.3 / 23 February 2020
167
Substance Name Acronym CAS #
No
of
PC
No. of sites
monitored
No. of sites
>LOQ
% of sites
>LOQ
PC with
detections
Status
Perfluorooctane
Sulfonamide
PFOSA 754-91-6 6 1,715 22 1.3 4
GW
WL
Perfluoroundecanoic
Acid
PFUnA 307-55-1 7 2,598 39 1.5 6
GW
WL
Perfluorododecanoic
Acid
PFDoA
2058-94-
8
7 2,830 62 2.2 6
GW
WL
Perfluorodecanoic
Acid
PFDA 335-76-2 8 2,945 173 5.9 7 LFR
Perfluorononanoic
Acid
PFNA 375-95-1 8 3,752 195 5.2 7 LFR
Perfluorobutanoic
Acid
PFBA 375-22-4 5 1,189 552 46.4 5 LFR
Perfluorobutane
Sulfonate
PFBS 375-73-5 7 2,209 577 26.1 5 LFR
Perfluoropentanoic
Acid
PFPeA
2706-90-
3
7 2,452 701 28.6 7 LFR
Perfluoroheptanoic
Acid
PFHpA 375-85-9 9 4,224 817 19.3 8 LFR
Perfluorohexane
Sulfonate
PFHxS 432-50-8 8 2,328 873 37.5 7 LFR
Perfluorohexanoic
Acid
PFHxA 307-24-4 9 4,662 1,175 25.2 8 LFR
Perfluorooctane
Sulfonate
PFOS
1763-23-
1
11 6,971 1,435 20.6 11 LFR
Perfluorooctanoic
Acid
PFOA 335-67-1 11 6,429 1,553 24.2 11 LFR
2.1.2. Pharmaceuticals
The two pharmaceuticals on the LFR are Carbamazepine and Sulfamethoxazole. A
further 9 substances were put on the GW WL so that more information could be collected
on their distribution in groundwater. These were: Clopidol, Crotamiton, Amidozoic acid,
Sulfadiazin, Primidone, Sotalol, Ibuprofen, Erythromycin and Clarithromycin. In 2022 at
the WG GW meeting and the final stakeholder workshop of this project it was indicated
that there was sufficient evidence available to support the inclusion of Primidone (a beta
blocker)104
on the LFR. This was discussed at WG GW Plenary in March 2022 and also
in the 2nd Stakeholder Workshop in March 2022. In addition, the proposed Option 3
includes adding 8 further pharmaceuticals from the GW WL to Annex II for
consideration by MS.
For the GW WL process, 13 PC provided groundwater datasets for review. The review
found around 300 pharmaceutical substances have been monitored by PCs but only a
small number of these were detected in more than 4 countries. Only 2 pharmaceuticals,
Sulfamethoxazole and Carbamazepine, were present in both 4 or more PC and at 10 or
more sites in each of these countries and were put forward on the LFR.
104
Primidone is a beta blocker / barbiturate medication used as an anticonvulsant or to treat partial and generalized seizures as well as
essential tremors. It is available as a generic medication. In 2017, it was the 238th most commonly prescribed medication in the
United States, with more than two million prescriptions.
168
2.1.3. Non-Relevant Metabolites (nrMs) of Pesticides105
Through the GW WL process, 17 countries provided groundwater data on the nrM
compounds for review. The data indicate that nrMs were widely detected in European
groundwater above limits of quantification (LoQ). The nrM monitoring results show 16
substances were detected in four or more PC and at 10 or more sites in each of these
countries (see Table A7.2). These substances fulfilled the criteria for addition to the LFR.
From the assessment, WG GW concluded that there is enough evidence of a Europe-wide
presence of nrMs in groundwater. Therefore, these 16 nrMs were put forward in a LFR
and it was recommended that other nrMs are not added to the GW WL.
Table A7.2: The 16 non-relevant metabolites on the List Facilitating Review of the GWD Annexes
nRM substance CAS
Parent
Compound
Use
Status (EU pesticides
database)
1 Desphenylchloridazon
(metabolite B)
6339-19-1 Chloridazon Herbicide
Not approved
(EC1107/2009)
2 Methyl-desphenyl-chloridazon
(Metabolite B1)
17254-80-7 Chloridazon Herbicide
Not approved
(EC1107/2009)
3
2,6-Dichlorbenzamid (2,6-D,
BAM, M01, AE C653711)
2008-58-4
Dichlobenil
Fluopicolide
Herbicide
Fungicide
Not approved
(EC1107/2009)
Approved
4 Aminomethylphosphonic acid 1066-51-9 Glyphosate Herbicide Approved
5 Metazachlor-acid (OXA) (BH
479-4)
1231244-
60-2
Metazachlor Herbicide Approved
6 Metazachlor ESA Metazachlor-
SA (BH 479- 8)
(Metazachlorsulfone acid,
Metazachlorsulfonic acid (ESA)
172960-62-
2
Metazachlor Herbicide Approved
7
Atrazine-2-hydroxy 2163-68-0 Atrazine Herbicide
Not approved since
2004
8
N,N-Dimethylsulfamid (DMS) 3984-14-3
Tolylfluanid,
Dichlofluanid
Fungicide
Not approved (EC
1107/2009)
9 s-Metolachlor-acid, (OXA,
CGA 51202, CGA 351916)
152019-73-
3
S-metolachlor Herbicide
Not Approved (EC
1107/2009)
10 Chlorthalonil-SA (R417888 or
VIS-01 / M12)
(Chlortalonilsulfone acid)
1418095-
02-9
Chlorothalonil Fungicide Not registered
11 Metolachlor-Ethanesulfonic
acid (ESA, CGA 380168, CGA
354743)
171118-09-
5
S-metolachlor Herbicide
Not Approved (EC
1107/2009)
12
Dimethenamid-ESA
205939-58-
8
Dimethenamid Herbicide Not approved
13 Flufenacet-sulfonic acid (ESA)
201668-32-8
Flufenacet Herbicide Approved
14
Alachlor-t-sulfonic-acid (ESA)
142363-53-
9
Alachlor Herbicide Not approved
15
S-Metolachlor NOA 413173 or
VIS-01 (Chlortalonilsulfone
acid) Metabolite
1418095-
19-8
Chlorothalonil
S-metolachlor
Herbicide
Not registered
Not Approved (EC
1107/2009)
105
Desphenyl-chloridazon (Metabolite B); Methyl-desphenyl-chloridazon (Metabolite B1); 2,6-Dichlorbenzamid (2,6-D, BAM, M01,
AE C653711); Aminomethylphosphonic acid (AMPA); Metazachlor-acid (OXA) (BH 479-4); Metazachlor ESA Metazachlor-SA
(BH 479- 8) (Metazachlor-sulfonic acid (ESA); Atrazine-2-hydroxy; N,N-Dimethylsulfamid (DMS); s-Metolachlor-acid, (OXA,
CGA 51202, CGA 351916); Chlorthalonil-SA (R417888 or VIS-01 / M12) (Chlorthalonil sulfonic acid); Metolachlor-sulfonic acid
(ESA, CGA 380168, CGA 354743); Dimethenamid-ESA; Flufenacet-sulfonic acid (ESA) 201668-32-8; Alachlor-t-sulfonic-acid
(ESA); S-Metolachlor NOA 413173 or VIS-01 (Chlortalonilsulfone acid) Metabolite; Dimethachlor CGA 369873 1418095-08-5.
169
nRM substance CAS
Parent
Compound
Use
Status (EU pesticides
database)
16 Dimethachlor CGA 369873
1418095-08-5
Dimethachlor Herbicide Approved
3. Derivation of groundwater quality standards
3.1. Annex I or Annex II?
Under the GWD substances can be added to Annex I or Annex II. Inclusion of a
substance in Annex I needs to be accompanied by an EU-wide groundwater quality
standard (GW QS). Substances added to Annex II must be considered by MS during the
risk assessment phase of river basin management planning, and appropriate threshold
values (TVs) must be set at national level, also considering the background
concentrations of naturally occurring substances. The choice of Annex is likely to reflect
the extent of the problem and could influence the effort needed to meet the
environmental objectives for groundwater.
3.2. Links with the Drinking Water Directive
Although the PFAS listed for surface water and in the recast of the Drinking Water
Directive were selected using criteria related to human health and ecotoxicity, new
scientific evidence became available towards the end of the adoption process. One
example of this is the 2020 scientific opinion from the European Food Safety Authority
(EFSA), outlining risks to human health arising from PFAS in human food are higher
than previously assumed. This information arrived too late in the process to be reflected
in the revised DW standards. In light of the ever-increasing evidence of the harmful
effects of PFAS to human health, this new information is included in the scientific
process to derive the EQS.
3.3. Links with the derivation of EQS for PS
Regarding PFAS, the situation of standard setting based on groundwater monitoring data
is slightly diverging from the situation for surface waters. This is primarily caused by the
fact that different PFAS substances are identified in surface waters compared to those
found in groundwater due to the long lag times associated with adsorption processes in
soil layers. Once the adsorption capacity is exhausted however, the same substances will
start to appear in GW as well, which is potentially highly problematic since groundwater
is the primary source for producing drinking water in the EU.
Group of 10 PFAS106
was originally proposed for groundwater, differing from the 24
PFAS substances proposed for surface water.
3.4. Opinions of the SCHEER107
The SCHEER was asked to evaluate groundwater quality standards for proposed
additional pollutants, including pollutant groups, in the annexes to the GWD. To do so,
106
Perfluorobutanoic Acid, Perfluorobutane Sulfonate, Perfluorodecanoic Acid, Perfluoroheptanoic Acid, Perfluorohexanoic Acid,
Perfluorohexane Sulfonate, Perfluorononanoic Acid, Perfluorooctanoic Acid, Perfluorooctane Sulfonate, Perfluoropentanoic Acid.
107
https://ec.europa.eu/health/publications/groundwater-quality-standards-proposed-additional-pollutants-annexes-groundwater-
directive-2006118ec_en
170
the SCHEER discussed the specificity of groundwater ecosystems, the relationship
between quality standards for surface waters (freshwaters) and groundwater, the risk
assessment of mixtures, and the harmonisation of quality standards in MS.
General conclusions:
 uniform EU-wide quality standards should be set for the groundwater body for
chemicals with no natural background concentrations,
 it is appropriate to apply freshwater EQSs to groundwater given that these would
have included an AF to account for the considerable surface freshwater
biodiversity,
 groundwater quality standards should not exceed the concentrations put forward
as quality standards for surface waters (AA-EQS),
 quality standards set for groundwater should be less strict than those for drinking
water,
 for harmonising principles, drinking water QS may be used as GW standards,
unless lower specific EQS exist, such as, for pharmaceuticals.
For PFAS:
 similar quality standards should be used for freshwater and groundwater,
 the relative potency factor (RPF) approach could be used for QSs of PFAS, and
that the value of 4.4 ng/L for PFOA equivalents can be adopted as a quality
standard for GW. The SCHEER did not agree with an EU group quality standard
of “PFAS-30 total” of 0.50 μg/L.
For Pharmaceuticals:
 the value of 0.5 μg/L proposed as a groundwater quality standard for
carbamazepine may not be sufficiently protective.
 the proposal for a sulfamethoxazole groundwater quality standard of 0.1 μg/L
may not be sufficiently protective for human health, ecosystems and for antibiotic
resistance,
 a general standard of 0.5 μg/L for all pharmaceuticals would not be sufficiently
protective,
 there is no scientific reason to consider moving pharmaceuticals as a group to
Annex II.
For non-relevant metabolites of plant protection products:
 a uniform approach should be followed in the evaluation of nrMs,
 not all sixteen metabolites were correctly identified as “non-relevant”,
 the proposal to use a uniform quality standard(s) for individual nrMs and for total
nrMs does provide adequate protection for human health and dependent
ecosystems,
 a group total quality standard for nrMs of 10 μg/L is not supported,
 a value of 0.75 μg/L for all non-relevant metabolites should protect human health
if no additional relevant toxicological information is made available, e.g., ED
effects. However, the SCHEER recommends to use a value of 0.1 μg/L as an
interim quality standard for nrMs in the groundwater body, protecting exposed
groundwater biota,
 the approach should not be limited to the 16 nrMs currently identified but also
applied to other nrMs identified in the future.
171
3.5. Groundwater option selection
Following the comments of the Regulatory Scrutiny Board stating that the groundwater
option design was complex and too technical, an attempt to re-arrange and simplify the
available policy choices and their presentation in the main report was made. Instead of
aggregating options per each substance group (i.e. PFAS, pharmaceuticals and nrMs), the
design was changed to better reflect the legislative choices (i.e. Annex I or Annex II?;
listing individually or as groups?). This presentation also aligns with surface water option
design and increases the coherence within the IA report.
Table A7.3 shows all the options for the LFR substances, presented in the arrangement of
Annex I/Annex II policy choices as in the main report, but including the original
numbering as in the support study. The opinions of the SCHEER are also indicated as
they were the main driver for selection of one option over another concerning the same
substance within the same policy option. The differences among these choices relate to
the scope of addition (i.e. substances included as group of some listed compounds or all)
and the proposed quality standard. The rationale of selection among the original options
for PFAS and nrMs concerning their Annex I listing individually is explained below.
Table A7.3: Transposition of groundwater options from the IA support study to the SWD main text
Policy
option
Description
Option No. in
support study
& SCHEER
opinion
Included in
main text of
IA SWD?
Option 1 Add LFR substances to GWD Annex I individually or as group of specific chemicals
PFAS
PFAS (Group of 10) included in Annex I and assigned a GW QS of
0.10 µg/l as “sum of” the 10 PFAS.
1a No
PFAS (Group of 24 as for SW) included in Annex I and assigned a
GW QS of 4.4 ng/l sum of PFOA-equivalents.
1d (SCHEER
recommended)
Yes
Pharma-
ceuticals
Carbamazepine and Sulfamethoxazole added to Annex I and assigned
GW QS of 0.5 and 0.1 µg/l respectively (protective of human health).
2a (SCHEER
endorsed)
Yes
nrMs
nrMs (Group of 16) added to Annex I as individual substances with a
GW QS of 1 µg/l.
3a No
nrMs (Group of 16) added to Annex I as individual substances with a
GW QS of 0.1 µg/l (protective of human health and groundwater
biota).
3d (SCHEER
recommended)
No
All nrMs added to Annex I as individual substances with a GW QS of
0.1 µg/l (protective of human health and groundwater biota).
3e (SCHEER
recommended
+ future
proofing)
Yes
Option 2 Add LFR substances to GWD Annex I as groups of all substances
PFAS
All PFAS added as group to Annex I with a GW QS for “PFAS total”
of 0.5 µg/l (again following the drinking water standard for PFAS
total).
1b Yes
Pharma-
ceuticals
Pharmaceuticals added as a group to Annex I and assigned a GW QS
of 0.5 µg/l.
2b Yes
nrMs
All nrMs added to Annex I as a group and assigned a group GW QS
of 10 µg/l (analogous with the existing group value for “pesticides”).
3b Yes
Option 3 Add LFR substances to GWD Annex II
PFAS
All PFAS added as a group to Annex II for MS to consider setting a
TV for specific substances posing a risk to groundwater bodies
(GWBs).
1c Yes
Pharma-
ceuticals
All pharmaceuticals added as a group to Annex II for MS to consider
setting a TV for substances that pose a risk to their GWBs. The
specific pharmaceuticals on the LFR are included in the minimum list
for consideration, with a guideline to include Primidone.
2c Yes
nrMs All nrMs added to Annex II for MS to consider a TV for substances 3c Yes
172
Policy
option
Description
Option No. in
support study
& SCHEER
opinion
Included in
main text of
IA SWD?
that pose a risk to their GWBs.
For PFAS:
Option 1a is based on the findings from the GW WL which indicates 10 PFAS for
addition to the LFR (see Table A7.1). The proposed QS is based on the drinking water
standard for 20 identified PFAS108
– the 10 PFAS would be a subset of the 20. This
option was not endorsed by the SCHEER.
Option 1d was proposed by the SCHEER in their Preliminary Opinion on groundwater
quality standards REF. This option entails an individual standard of 4.4 ng/l PFOA-
equivalent for the 24 listed PFAS in line with surface water EQS. The concentration of
each listed PFAS would be calculated using the relative potency factor (RPF) compared
to PFOA. For PFAS not included on the PS list, the PFOA RPF would be used to
calculate the GW QS. If no RPF exists, then the RPF of PFOA should be assumed and a
GW QS of 4.4 ng/l applied. For some reservations regarding this approach, see section
3.6 below.
For nrMs:
Option 3a is based on reported TVs used by MS which range from 0.1 µg/l to 1 µg/l
(with an exceptional case of 4.5 µg/l for one particular nrM) and a uniform value of 1
µg/l is proposed by analogy with the existing uniform value for individual “pesticides” in
Annex I of the GWD. Commission guidance (2003 and 2021) suggests a case-by-case
assessment but with an (individual) upper limit of 10 µg/l and a value of 0.75 µg/l if a
risk assessment has been performed but is incomplete. This option was not endorsed by
the SCHEER.
The SCHEER recommendations for nrMs were translated into Options 3d and 3e. The
difference between these two options is the number of nrMs covered: the 16 individual
compounds as identified by the GW WL (see Table A7.2) or all nrMs. The wider scope
of Option 3e contributes to future-proofing the legislation as it sets a limit for any nrM
compound found in groundwater even if not explicitly mentioned in the legislation.
Therefore, out of the two SCHEER proposals, Option 3e was selected to represent the
Annex I individual listing policy choice in the main text of this document.
3.6. Considerations around the possible use of Relative Potency Factors for
PFAS
A number of governmental bodies in the EU (EFSA) and the United States have
proposed health-based standards or guidelines for PFAS in water and/or food based on
108
This refers to the following compounds: Perfluorooctanoic acid (PFOA) (CAS 335-67-1), Perfluorooctane sulfonic acid (PFOS)
(CAS 1763-23-1), Perfluorohexane sulfonic acid (PFHxS) (CAS 355-46-4), Perfluorononanoic acid (PFNA) (CAS 375-95-1),
Perfluorobutane sulfonic acid (PFBS) (CAS 375-73-5), Perfluorohexanoic acid (PFHxA) (CAS 307-24-4), Perfluorobutanoic acid
(PFBA) (CAS 375-22-4), Perfluoropentanoic acid (PFPeA) (CAS 2706-90-3), Perfluoropentane sulfonic acid (PFPeS) (CAS 2706-91-
4), Perfluorodecanoic acid (PFDA) (CAS 335-76-2), Perfluorododecanoic acid (PFDoDA or PFDoA) (CAS 307-55-1),
Perfluoroundecanoic acid (PFUnDA or PFUnA) (CAS 2058-94-8), Perfluoroheptanoic acid (PFHpA) (CAS 375-85-9),
Perfluorotridecanoic acid (PFTrDA) (CAS 72629-94-8), Perfluoroheptane sulfonic acid (PFHpS) (CAS 375-92-8), Perfluorodecane
sulfonic acid (PFDS) (CAS 335-77-3), Perfluorononane sulfonic acid (PFNS) (CAS 68259-12-1), Perfluoroundecane sulfonic acid
(PFUnDS) (CAS 749786-16-1), Perfluorododecane sulfonic acid / 10:2 Fluorotelomer sulfonic acid (PFDoS or PFDoDS) (CAS
120226-60-0) and Perfluorotridecane sulfonic acid (PFTrDS or PFTriS) (CAS 791563-89-8).
173
one or more relatively better-studied PFAS such as PFOA or PFOS (EFSA bases its limit
on epidemiologic results for the sum of four PFAS) (113) (114). To this is compared the
sum of concentrations of a small number of PFAS including some that are less well
studied but are thought likely to have similar pharmacokinetics and toxicity. This
summing approach is concentration additive. A refinement of this approach using relative
potency factors (RPFs) has also been proposed (115), but this additional step is not yet
warranted for legislative purposes.
Concentration addition (CA) is based on the idea that compounds “work together” to
bring about a biological effect. The simplest form of CA is RPFs in which all compounds
in the system are assumed to have the same concentration-response curve differing only
in potency. The concentrations of compounds are multiplied by their potency relative to a
reference compound – generally the one best studied – and summed. The sum is then
inserted into the concentration-response function of the reference compound.
The best known RPF system is for dioxin-like compounds where the RPFs are called
TEFs and 2,3,7,8-TCDD is the reference compound (117). The TEF system has been
widely tested. Its validity depends in part on the fact that dioxin-like compounds are
believed to act via the AhR, a cellular receptor. Here the AhR acts as the molecular
initiating event (MIE). Assuming that downstream biological effects are a function of the
signal arising from the MIE, the RPF model (indeed other mixtures effects) should still
apply at downstream biological effects even if the concentration-response curve has
changed (116).
There are two main problems with applying a RPF system to PFAS:
1) There may be more than one MIE. PFAS can bind to a number of receptors, e.g.
(118). Although it is possible that key sensitive biological outcomes might depend
on a single MIE, the biology is not well enough understood to know this yet or
which one. When there is more than one MIE it is more difficult to predict the
downstream mixture effects. Converging AOPs may or may not lead to CA
downstream, although CA might be the more protective default position.
2) PPARα is one of the better studied MIEs for PFAS and may be involved with
effects in the liver and elsewhere. A recent paper (118) studied concentration-
response curves for a number of PFAS using a reporter-cell line and compared
mixture results with several different models. They found that PFAS can differ in
both potency and efficacy (i.e., maximal effect), violating an assumption of the
RPF model. Consequently, the RPF model did worse at predicting mixture effects
than other more general models that do not make this assumption.
While research into RPF models for PFAS is worthwhile, it is premature to use them as a
basis for regulation as it would place more confidence in the values of the RPFs than is
warranted at this time. Consequently, one or both of the following options are preferred:
1) The current system of summing a small number of PFAS for which there are some
data appears to be a reasonable first step. While one can think of this procedure as
assuming the same RPF (one) for all compounds, it makes the uncertainty behind
this assumption explicit. One problem with this approach is that it can ignore other
PFAS. To limit the risks of that an additional uncertainty factor to take this into
account is considered.
2) Another approach could examine extractable organic fluorine (EOF). Typically there
is a gap between the total EOF in a sample of water, serum, and other media and that
which can be explained by measured PFAS, e.g. (119). The identity of the
174
uncharacterized EOF is not known and is a current area of research. Although it is
unlikely that all of the compounds in a sample that contribute to EOF have the same
kind of toxicity, such an approach might serve as a warning sign.
175
ANNEX 8: RESULTS OF THE QUALITY STANDARD DERIVATION PROCESS FOR REVISION OF THE ANNEXES TO THE EQSD AND GWD
ANNEX I to Directive 2008/105/EC
ENVIRONMENTAL QUALITY STANDARDS (EQS) FOR PRIORITY SUBSTANCES IN SURFACE WATERS
Note: Where an EQS is listed between [] this value is subject to confirmation in the light of the opinion requested from the Scientific Committee on
Health, Environmental and Emerging Risks.
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13)
N° Name of substance Category of
substances
CAS
number (1
)
EU number
(2
)
AA-EQS (3
)
Inland
surface
waters (4
)
[µg/l]
AA-EQS (3
)
Other surface
waters
[µg/l]
MAC-EQS
(5
)
Inland
surface
waters (4Error!
Bookmark not
defined.
)
[µg/l]
MAC-EQS
(5
)
Other
surface
waters
[µg/l]
EQS
Biota (6
)
[µg/kg wet
weight]
or EQS
Sediment
[µg /kg dry
weight]
where so
indicated
Identified as
priority
hazardous
substance
Identified as
Ubiquitous
Persistent,
Bioaccumul
ative and
Toxic
(uPBT)
substance
Identified
as
substance
that tends
to
accumula
te in
sediment
and/or
biota
(2) Anthracene Industrial
substances
120-12-7 204-371-1 0,1 0,1 0,1 0,1 X X
(3) Atrazine Herbicides 1912-24-9 217-617-8 0,6 0,6 2,0 2,0
(4) Benzene Industrial
substances
71-43-2 200-753-7 10 8 50 50
(5) Brominated
diphenylethers
Industrial
substances
not
applicable
not
applicable
0,14 (7
) 0,014 (7
) [0,00028]
(7
)
X (8
) X X
176
(6) Cadmium and its
compounds
(depending on water
hardness classes) (9
)
Metals 7440-43-9 231-152-8 ≤ 0,08 (Class
1)
0,08 (Class
2)
0,09 (Class
3)
0,15 (Class
4)
0,25 (Class
5)
0,2 ≤ 0,45 (Class
1)
0,45 (Class
2)
0,6 (Class 3)
0,9 (Class 4)
1,5 (Class 5)
≤ 0,45 (Class
1)
0,45 (Class
2)
0,6 (Class 3)
0,9 (Class 4)
1,5 (Class 5)
X X
(7) C10-13 Chloroalkanes (10
) Industrial
substances
85535-84-
8
287-476-5 0,4 0,4 1,4 1,4 X X
(9) Chlorpyrifos
(Chlorpyrifos-ethyl)
Organophosp
hate
pesticides
2921-88-2 220-864-4 0, 00046 4,6 10-5
0,0026 0,00052 X X X
(9a) Cyclodiene pesticides:
Aldrin
Dieldrin
Endrin
Isodrin
Organochlori
ne pesticides 309-00-2
60-57-1
72-20-8
465-73-6
206-215-8
200-484-5
200-775-7
207-366-2
Σ = 0,01 Σ = 0,005 not
applicable
not
applicable
X
(9b) DDT total (11
) Organochlori
ne pesticides
not
applicable
not
applicable
0,025 0,025 not
applicable
not
applicable
X
para-para-DDT 50-29-3 200-024-3 0,01 0.01 not
applicable
not
applicable
X
(10) 1,2-Dichloroethane Industrial
substances
107-06-2 203-458-1 10 10 not
applicable
not
applicable
X
(11) Dichloromethane Industrial
substances
75-09-2 200-838-9 20 20 not
applicable
not
applicable
(12) Di(2-ethylhexyl)-
phthalate (DEHP)
Industrial
substances
117-81-7 204-211-0 1,3 1,3 not
applicable
not
applicable
X X
(13) Diuron Herbicides 330-54-1 206-354-4 0,049 0,0049 0,268 0,054
177
(14) Endosulfan Organochlori
ne pesticides
115-29-7 204-079-4 0,005 0,0005 0,01 0,004 X
(15) Fluoranthene Industrial
substances
206-44-0 205-912-4 7,62 10-4
7,62 10-4
0,012] 0,012 6,1 X X X
(16) Hexachlorobenzene Organochlori
ne pesticides
118-74-1 204-273-9 0,5 0,05 19,63 X X
(17) Hexachlorobutadiene Industrial
substances
(solvents)
87-68-3 201-765-5 0,44 0,044 0,6 0,6 24,5 X X
(18) Hexachlorocyclohexane Insecticides 608-73-1 210-168-9 0,02 0,002 0,04 0,02 X X
(19) Isoproturon Herbicides 34123-59-
6
251-835-4 0,3 0,3 1,0 1,0
(20) Lead and its compounds Metals 7439-92-1 231-100-4 1,2 (12)
1,3 14 14 X X
(21) Mercury and its
compounds
Metals 7439-97-6 231-106-7 0,07 0,07 [0,255] X X X
(22) Naphthalene Industrial
substances
91-20-3 202-049-5 2 2 130 130
(23) Nickel and its
compounds
Metals 7440-02-0 231-111-4 2 (12
) 3,1 8,2 8,2
(24) Nonylphenols (13
)
(4-Nonylphenol)
Industrial
substances
84852-15-
3
284-325-5 0,037 0,00182 2,0 0,17 X
(25) Octylphenols (14
)
((4-(1,1',3,3'-
tetramethylbutyl)-
phenol))
Industrial
substances
140-66-9 205-426-2 0,1 0,01 not
applicable
not
applicable
X
(26) Pentachlorobenzene Industrial
substances
608-93-5 210-172-0 0,007 0,0007 not
applicable
not
applicable
X X
(27) Pentachlorophenol Organochlori
ne pesticides
87-86-5 201-778-6 0,4 0,4 1 1 X
178
(28) Polyaromatic
hydrocarbons (PAHs)
(15
)
Combustion
products
not
applicable
not
applicable
not
applicable
not applicable not
applicable
not
applicable
Sum of
Benzo(a)p
yrene
equivalents
[0.6] (16
)
X X X
Benzo(a)pyrene 50-32-8 200-028-5 0,27 0,027 [0,6]
Benzo(b)fluoranthene 205-99-2 205-911-9 0,017 0,017 see
footnote 16
Benzo(k)fluoranthene 207-08-9 205-916-6 0,017 0,017 see
footnote 16
Benzo(g,h,i)perylene 191-24-2 205-883-8 8,2 10-3
8,2 10-4
see
footnote 16
Indeno(1,2,3-cd)pyrene 193-39-5 205-893-2 not
applicable
not
applicable
see
footnote 16
Chrysene 218-01-9 205-923-4 0,07 0,007 see
footnote 16
Benzo(a)anthracene 56-55-3 200-280-6 0,1 0,01 see
footnote 16
Dibenz(a,h)anthracene 53-70-3 200-181-8 0,014 0,0014 see
footnote 16
(29a) Tetrachloroethylene Industrial
substances
127-18-4 204-825-9 10 10 not
applicable
not
applicable
(29b) Trichloroethylene Industrial
substances
79-01-6 201-167-4 10 10 not
applicable
not
applicable
X
(30) Tributyltin compounds
(17
) (Tributyltin-cation)
Biocides 36643-28-
4
not
applicable
0,0002 0,0002 0,0015 0,0015 [1,3] (18
) X X X
(31) Trichlorobenzenes Industrial
substances
(solvents)
12002-48-
1
234-413-4 0,4 0,4 not
applicable
not
applicable
(32) Trichloromethane Industrial
substances
67-66-3 200-663-8 2,5 2,5 not
applicable
not
applicable
179
(33) Trifluralin Herbicides 1582-09-8 216-428-8 0,03 0,03 not
applicable
not
applicable
X
(34) Dicofol Organochlori
ne pesticides
115-32-2 204-082-0 [4,45 10-3
] [0,185 10-3
] not
applicable
(19
)
not
applicable
(19
)
[5.45] X X
(35) Perfluorooctane sulfonic
acid and its derivatives
(PFOS)
Industrial
substances
1763-23-1 217-179-8 See substance 65 (Per- and poly-fluorinated alkyl substances (PFAS) – sum of 24)
(36) Quinoxyfen Plant
protection
products
124495-
18-7
not
applicable
0,15 0,015 2,7 0,54 X X
(37) Dioxins and dioxin-like
compounds (20
)
Industrial
byproducts
not
applicable
not
applicable
not
applicable
not
applicable
Sum of
PCDDs+
PCDFs+
PCB-DLs
equivalents
[3,5 10-5
]
(21
)
X X X
(38) Aclonifen Herbicides 74070-46-
5
277-704-1 0,12 0,012 0,12 0,012
(39) Bifenox Herbicides 42576-02-
3
255-894-7 0,012 0,0012 0,04 0,004
(40) Cybutryne Biocides 28159-98-
0
248-872-3 0,0025 0,0025 0,016 0,016
(41) Cypermethrin (22
) Pyrethroid
pesticides
52315-07-
8
257-842-9 [3 10-5
] [3 10-6
] 6 10-4
6 10-5
X
(42) Dichlorvos Organophosp
hate
pesticides
62-73-7 200-547-7 6 10-4
6 10-5
7 10-4
7 10-5
180
(43) Hexabromocyclododeca
ne (HBCDD) (23
)
Industrial
substances
See
footnote
Error!
Bookmar
k not
defined.3
See
footnote 23
[4.6 10-4
] [2 10-5
] 0,5 0,05 [3.5] X X X
(44) Heptachlor and
heptachlor epoxide
Organochlori
ne pesticides
76-44-8 /
1024-57-3
200-962-3/
213-831-0
[1,7 10-7
] [1,7 10-7
] 3 10-4
3 10-5
[0,013] X X X
(45) Terbutryn Herbicides 886-50-0 212-950-5 0,065 0,0065 0,34 0,034
(46) 17 alpha-ethinylestradiol
(EE2)
Pharmaceutic
als
(Estrogenic
hormones)
57-63-6 200-342-2 1,7 10-5
1,6 10-6
not derived not derived
(47) 17 beta-estradiol (E2) Pharmaceutic
als
(Estrogenic
hormones)
50-28-2 200-023-8 0,00018 9 10-6
not derived not derived
(48) Acetamiprid Neonicotinoi
d pesticides
135410-
20-7 /
160430-
64-8
603-921-1 0,037 0,0037 0,16 0,016
(49) Azithromycin Pharmaceutic
als
(Macrolide
antibiotics)
83905-01-
5
617-500-5 0,019 0,0019 0,18 0,018 X
(50) Bifenthrin Pyrethroid
pesticides
82657-04-
3
617-373-6 9,5 10-5
9,5 10-6
0,011 0,001 X
(51) Bisphenol-A (BPA) Industrial
substances
80-05-7 201-245-8 [0.46] [0.46] [129] [31] X
(52) Carbamazepine Pharmaceutic
als
298-46-4 206-062-7 2,5 0,25 1,6 103
160
181
(53) Clarithromycin Pharmaceutic
als
(Macrolide
antibiotics)
81103-11-
9
658-034-2 0,13 0,013 0,13 0,013 X
(54) Clothianidin Neonicotinoi
d pesticides
210880-
92-5
433-460-1 0,01 0,001 0,34 0,034
(55) Deltamethrin Pyrethroid
pesticides
52918-63-
5
258-256-6 1,7 10-6
1,7 10-7
1,7 10-5
3,4 10-6
X
(56) Diclofenac Pharmaceutic
als
15307-86-
5 / 15307-
79-6
239-348-5 /
239-346-4
0,04 0,004 290 29 X
(57) Erythromycin Pharmaceutic
als
(Macrolide
antibiotics)
114-07-8 204-040-1 0,5 0,05 1 0,1 X
(58) Esfenvalerate Pyrethroid
pesticides
66230-04-
4
613-911-9 1,7 10-5
1,7 10-6
0.0085 0.00085 X
(59) Estrone (E1) Pharmaceutic
als
(Estrogenic
hormones)
53-16-7 200-164-5 0,00036 0,000018 not derived not derived
(60) Glyphosate Herbicides 1071-83-6 213-997-4 0,1109
90110
9 398,6 39,86
(61) Ibuprofen Pharmaceutic
als
15687-27-
1
239-784-6 0,22 0,022] X
(62) Imidacloprid Neonicotinoi
d pesticides
138261-
41-3 /
105827-
78-9
428-040-8 0,0068 0,00068 0,057 0,0057
109
For freshwater used for the abstraction and preparation of drinking water
110
For freshwater not used for the abstraction and preparation of drinking water
182
(63) Nicosulfuron Herbicides 111991-
09-4
601-148-4 0,0087 0,00087 0,23 0,023
(64) Permethrin Pyrethroid
pesticides
52645-53-
1
258-067-9 0,00027 2.7 10-5
0,0025 0,00025 X
(65) Per- and poly-
fluorinated alkyl
substances (PFAS) –
sum of 24 (24
)
Industrial
substances
not
applicable
not
applicable
Sum of
PFOA
equivalents
0,0044 (25
)
Sum of PFOA
equivalents
0,0044 (25
)
not
applicable
not
applicable
Sum of
PFOA
equivalents
0,077 (25
)
X X X
(66) Silver Metals 7440-22-4 231-131-3 0,01 0,006 (10%
salinity)
0,17 (30%
salinity)
0,022 not derived
(67) Thiacloprid Neonicotinoi
d pesticides
111988-
49-9
601-147-9 0,01 0,001 0,05 0,005
(68) Thiamethoxam Neonicotinoi
d pesticides
153719-
23-4
428-650-4 0,04 0,004 0,77 0,077
(69) Triclosan Biocides 3380-34-5 222-182-2 0,02 0,0156 0,02 0,0156
(70) Total of active
substances in pesticides,
including their relevant
metabolites, degradation
and reaction products
(26
)
Plant
protection
products and
biocides
0.5 (27
) 0.5 (27
)
(1
) CAS: Chemical Abstracts Service.
(2
) EU number: European Inventory of Existing Commercial Substances (EINECS) or European List of Notified Chemical Substances (ELINCS).
(3
) This parameter is the EQS expressed as an annual average value (AA-EQS). Unless otherwise specified, it applies to the total concentration of all substances and isomers.
(4
) Inland surface waters encompass rivers and lakes and related artificial or heavily modified water bodies.
(5
) This parameter is the EQS expressed as a maximum allowable concentration (MAC EQS). Where the MAC EQS are marked as "not applicable", the AA EQS values are
considered protective against short-term pollution peaks in continuous discharges since they are significantly lower than the values derived on the basis of acute toxicity.
(6
) If an EQS biota is given, it, rather than the water EQS, shall be applied, without prejudice to the provision in Article 3(3) of this Directive allowing an alternative biota taxon, or
another matrix, to be monitored instead, as long as the EQS applied provides an equivalent level of protection. Unless otherwise indicated, the biota EQS relate to fish. For
substances numbered 15 (Fluoranthene) and 28 (PAHs), the biota EQS refers to crustaceans and molluscs. For the purpose of assessing chemical status, monitoring of
183
Fluoranthene and PAHs in fish is not appropriate. For substance number 37 (Dioxins and dioxin-like compounds), the biota EQS relates to fish, crustaceans and molluscs, in line
with Commission Regulation (EU) No 1259/2011* Annex Section 5.3.
(7
) For the group of priority substances covered by brominated diphenylethers (No 5), the EQS refer to the sum of the concentrations of congener numbers 28, 47, 99, 100, 153 and
154.
(8
) Tetra, Penta, Hexa, Hepta, Octa and Decabromodiphenylether (CAS numbers 40088-47-9, 32534-81-9, 36483-60-0, 68928-80-3, 32536-52-0, 1163-19-5, respectively).
(9
) For Cadmium and its compounds (No 6) the EQS values vary depending on the hardness of the water as specified in five class categories (Class 1: <40 mg CaCO3/l, Class 2: 40
to <50 mg CaCO3/l, Class 3: 50 to <100 mg CaCO3/l, Class 4: 100 to <200 mg CaCO3/l and Class 5: ≥200 mg CaCO3/l).
(10
) No indicative parameter is provided for this group of substances. The indicative parameter(s) must be defined through the analytical method.
(11
) DDT total comprises the sum of the isomers 1,1,1 trichloro 2,2 bis (p chlorophenyl) ethane (CAS 50 29 3, EU 200 024 3); 1,1,1 trichloro 2 (o chlorophenyl) 2 (p chlorophenyl)
ethane (CAS 789 02 6, EU 212 332 5); 1,1-dichloro 2,2 bis (p chlorophenyl) ethylene (CAS 72 55 9, EU 200 784 6); and 1,1 dichloro 2,2 bis (p chlorophenyl) ethane (CAS 72
54 8, EU 200 783 0).
(12
) These EQS refer to bioavailable concentrations of the substances.
(13
) Nonylphenol (CAS 25154-52-3, EU 246-672-0) including isomers 4-nonylphenol (CAS 104-40-5, EU 203-199-4) and 4-nonylphenol (branched) (CAS 84852-15-3, EU 284-
325-5).
(14
) Octylphenol (CAS 1806-26-4, EU 217-302-5) including isomer 4-(1,1',3,3'-tetramethylbutyl)-phenol (CAS 140-66-9, EU 205-426-2).
(15
) Benzo(a)pyrene (CAS 50-32-8) (RPF 1), benzo(b)fluoranthene (CAS 205-99-2) (RPF 0,1), benzo(k)fluoranthene (CAS 207-08-9) (RPF 0,1), benzo(g,h,i)perylene (CAS 191-24-
2) (RPF 0), indeno(1,2,3-cd)pyrene (CAS 193-39-5) (RPF 0,1), chrysene (CAS 218-01-9) (RPF 0,01), benzo(a)anthracene (CAS 56-55-3) (RPF 0,1), and dibenz(a,h)anthracene
(CAS 53-70-3) (RPF 1). The PAHs anthracene[, fluoranthene] and naphthalene are listed separately.
(16
) For the group of polyaromatic hydrocarbons (PAHs) (No 28), the biota EQS refers to the sum of the concentrations of seven of the eight PAHs listed in footnote 17 expressed
as.benzo(a)pyrene equivalents based on the carcinogenic potencies of the substances relative to that of benzo(a)pyrene, i.e. the RPFs in footnote 15. Benzo(g,h,i)perylene does
not need to be measured in biota for the purposes of determining compliance with the overall EQS biota.
(17
) Tributyltin compounds including tributyltin-cation (CAS 36643-28-4).
(18
) Sediment EQS
(19
) There is insufficient information available to set a MAC-EQS for these substances.
(20
) This refers to the following compounds:
7 polychlorinated dibenzo-p-dioxins (PCDDs): 2,3,7,8-T4CDD (CAS 1746-01-6, EU 217-122-7), 1,2,3,7,8-P5CDD (CAS 40321-76-4), 1,2,3,4,7,8-H6CDD (CAS 39227-28-6),
1,2,3,6,7,8-H6CDD (CAS 57653-85-7), 1,2,3,7,8,9-H6CDD (CAS 19408-74-3), 1,2,3,4,6,7,8-H7CDD (CAS 35822-46-9), 1,2,3,4,6,7,8,9-O8CDD (CAS 3268-87-9)
10 polychlorinated dibenzofurans (PCDFs): 2,3,7,8-T4CDF (CAS 51207-31-9), 1,2,3,7,8-P5CDF (CAS 57117-41-6), 2,3,4,7,8-P5CDF (CAS 57117-31-4), 1,2,3,4,7,8-H6CDF
(CAS 70648-26-9), 1,2,3,6,7,8-H6CDF (CAS 57117-44-9), 1,2,3,7,8,9-H6CDF (CAS 72918-21-9), 2,3,4,6,7,8-H6CDF (CAS 60851-34-5), 1,2,3,4,6,7,8-H7CDF (CAS 67562-
39-4), 1,2,3,4,7,8,9-H7CDF (CAS 55673-89-7), 1,2,3,4,6,7,8,9-O8CDF (CAS 39001-02-0)
12 dioxin-like polychlorinated biphenyls (PCB-DLs): 3,3’,4,4’-T4CB (PCB 77, CAS 32598-13-3), 3,3’,4’,5-T4CB (PCB 81, CAS 70362-50-4), 2,3,3',4,4'-P5CB (PCB 105,
CAS 32598-14-4), 2,3,4,4',5-P5CB (PCB 114, CAS 74472-37-0), 2,3',4,4',5-P5CB (PCB 118, CAS 31508-00-6), 2,3',4,4',5'-P5CB (PCB 123, CAS 65510-44-3), 3,3’,4,4’,5-
P5CB (PCB 126, CAS 57465-28-8), 2,3,3',4,4',5-H6CB (PCB 156, CAS 38380-08-4), 2,3,3',4,4',5'-H6CB (PCB 157, CAS 69782-90-7), 2,3',4,4',5,5'-H6CB (PCB 167, CAS
52663-72-6), 3,3’,4,4’,5,5’-H6CB (PCB 169, CAS 32774-16-6), 2,3,3',4,4',5,5'-H7CB (PCB 189, CAS 39635-31-9).
(21
) For the group of Dioxins and dioxin-like compounds (No 37), the biota EQS refers to the sum of the concentrations of the substances listed in footnote 20 expressed as toxic
equivalents based on the World Health Organisation 2005 Toxic Equivalence Factors.
(22
) CAS 52315-07-8 refers to an isomer mixture of cypermethrin, alpha-cypermethrin (CAS 67375-30-8, EU 257-842-9), beta-cypermethrin (CAS 65731-84-2, EU 265-898-0),
theta-cypermethrin (CAS 71691-59-1) and zeta-cypermethrin (CAS 52315-07-8, EU 257-842-9).
(23
) This refers to 1,3,5,7,9,11-Hexabromocyclododecane (CAS 25637-99-4, EU 247-148-4), 1,2,5,6,9,10- Hexabromocyclododecane (CAS 3194-55-6, EU 221-695-9), α-
Hexabromocyclododecane (CAS 134237-50-6), β-Hexabromocyclododecane (CAS 134237-51-7) and γ- Hexabromocyclododecane (CAS 134237-52-8).
(24
) This refers to the following compounds, listed with their CAS number, EU number and Relative Potency Factor (RPF)::
184
Perfluorooctanoic acid (PFOA) (CAS 335-67-1, EU 206-397-9) (RPF 1), Perfluorooctane sulfonic acid (PFOS) (CAS 1763-23-1, EU 217-179-8) (RPF 2), Perfluorohexane
sulfonic acid (PFHxS) (CAS 355-46-4, EU 206-587-1) (RPF 0,6), Perfluorononanoic acid (PFNA) (CAS 375-95-1, EU 206-801-3) (RPF 10), Perfluorobutane sulfonic acid
(PFBS) (CAS 375-73-5, EU 206-793-1) (RPF 0,001), Perfluorohexanoic acid (PFHxA) (CAS 307-24-4, EU 206-196-6) (RPF 0,01), Perfluorobutanoic acid (PFBA) (CAS 375-
22-4, EU 206-786-3) (RPF 0,05), Perfluoropentanoic acid (PFPeA) (CAS 2706-90-3, EU 220-300-7) (RPF 0,03), Perfluoropentane sulfonic acid (PFPeS) (CAS 2706-91-4, EU
220-301-2) (RPF 0,3005), Perfluorodecanoic acid (PFDA) (CAS 335-76-2, EU 206-400-3) (RPF 7), Perfluorododecanoic acid (PFDoDA or PFDoA) (CAS 307-55-1, EU 206-
203-2) (RPF 3), Perfluoroundecanoic acid (PFUnDA or PFUnA) (CAS 2058-94-8, EU 218-165-4) (RPF 4), Perfluoroheptanoic acid (PFHpA) (CAS 375-85-9, EU 206-798-9)
(RPF 0,505), Perfluorotridecanoic acid (PFTrDA) (CAS 72629-94-8, EU 276-745-2) (1,65), Perfluoroheptane sulfonic acid (PFHpS) (CAS 375-92-8, EU 206-800-8) (RPF 1,3),
Perfluorodecane sulfonic acid (PFDS) (CAS 335-77-3, EU 206-401-9) (RPF 2), Perfluorotetradecanoic acid (PFTeDA) (CAS 376-06-7, EU 206-803-4) (RPF 0,3),
Perfluorohexadecanoic acid (PFHxDA) (CAS 67905-19-5, EU 267-638-1) (RPF0,02), Perfluorooctadecanoic acid (PFODA) (CAS 16517-11-6, EU 240-582-5) (RPF 0,02), and
Ammonium perfluoro (2-methyl-3-oxahexanoate) (HFPO-DA or Gen X) (CAS 62037-80-3) (RPF 0,06), Propanoic Acid / Ammonium 2,2,3-trifluoro-3-(1,1,2,2,3,3-hexafluoro-
3-(trifluoromethoxy)propoxy)propanoate (ADONA) (CAS 958445-44-8) (RPF 0,03), 2- (Perfluorohexyl)ethyl alcohol (6:2 FTOH) (CAS 647-42-7, EU 211-477-1) (RPF 0,02),
2-(Perfluorooctyl)ethanol (8:2 FTOH) (CAS 678-39-7, EU 211-648-0) (RPF 0,04) and Acetic acid / 2,2-difluoro-2-((2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-
yl)oxy)- (c604) (CAS 1190931-41-9) (RPF 0,06)
(25
) For the group of PFAS (No 65), the EQS refer to the sum of the concentrations of the 24 PFAS listed in footnote 24 expressed as PFOA-equivalents based on the potencies of the
substances relative to that of PFOA, i.e. the RPFs in footnote 24.
(26
) ‘Pesticides’ means plant protection products and biocidal products as defined in Article 2 of 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 in Article 3 of 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, respectively.
(27
) ‘Total’ means the sum of all individual pesticides detected and quantified in the monitoring procedure, including their relevant metabolites, degradation and reaction products.
ANNEX I to Directive 2006/118/EC
GROUNDWATER QUALITY STANDARDS
(1) (2) (3) (4) (5) (6)
No
Name of
substance
Category of
substances
CAS number
(1
)
EU number
(2
)
Quality Standard (3
)
[µg/l unless otherwise
indicated]
1 Nitrates Nutrients not
applicable
not applicable 50 mg/l
2 Active
substances in
Pesticides not
applicable
not applicable 0,1
185
(1) (2) (3) (4) (5) (6)
pesticides,
including their
relevant
metabolites,
degradation and
reaction
products (4
)
0,5 (total) (5
)
3 Per- and poly-
fluorinated
alkyl substances
(PFAS) - sum
of 24 (6
)
Industrial
substances
See footnote
6
See footnote
6
0.0044 (7
)
4 Carbamazepine Pharmaceuticals 298-46-4 not applicable 0.25
5 Sulfamethoxazo
le
Pharmaceuticals 723-46-6 not applicable 0.01
6 Pharmaceutical
active
substances –
total (8
)
Pharmaceuticals not
applicable
not applicable 0.25
7 Non-relevant
metabolites of
pesticides
(nrMs)
Pesticides not
applicable
not applicable 0,1 (9
) or 1 (10
)
0,5 (9
) or 5 (10
)(total)
(11
)
(1
) CAS: Chemical Abstracts Service.
(2
) EU number: European Inventory of Existing Commercial Substances (EINECS) or European List of Notified Chemical Substances (ELINCS).
(3
) This parameter is the QS expressed as an annual average value. Unless otherwise specified, it applies to the total concentration of all substances and isomers.
(4
) ‘Pesticides’ means plant protection products and biocidal products as defined in Article 2 of 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 in Article 3 of 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, respectively.
(5
) ‘Total’ means the sum of all individual pesticides detected and quantified in the monitoring procedure, including their relevant metabolites, degradation and reaction products.
186
(6
) This refers to the following compounds, listed with their CAS number, EU number and Relative Potency Factor (RPF): Perfluorooctanoic acid (PFOA) (CAS 335-67-1, EU 206-
397-9) (RPF 1), Perfluorooctane sulfonic acid (PFOS) (CAS 1763-23-1, EU 217-179-8) (RPF 2), Perfluorohexane sulfonic acid (PFHxS) (CAS 355-46-4, EU 206-587-1) (RPF
0,6)), Perfluorononanoic acid (PFNA) (CAS 375-95-1, EU 206-801-3) (RPF 10), Perfluorobutane sulfonic acid (PFBS) (CAS 375-73-5, EU 206-793-1) (RPF 0,001),
Perfluorohexanoic acid (PFHxA) (CAS 307-24-4, EU 206-196-6) (RPF 0,01), Perfluorobutanoic acid (PFBA) (CAS 375-22-4, EU 206-786-3) (RPF 0,05), Perfluoropentanoic
acid (PFPeA) (CAS 2706-90-3, EU 220-300-7) (RPF 0,03), Perfluoropentane sulfonic acid (PFPeS) (CAS 2706-91-4, EU 220-301-2) (RPF 0,3005), Perfluorodecanoic acid
(PFDA) (CAS 335-76-2, EU 206-400-3) (RPF 7), Perfluorododecanoic acid (PFDoDA or PFDoA) (CAS 307-55-1, EU 206-203-2) (RPF 3), Perfluoroundecanoic acid (PFUnDA
or PFUnA) (CAS 2058-94-8, EU 218-165-4) (RPF 4), Perfluoroheptanoic acid (PFHpA) (CAS 375-85-9, EU 206-798-9) (RPF 0,505), Perfluorotridecanoic acid (PFTrDA)
(CAS 72629-94-8, EU 276-745-2) (1,65), Perfluoroheptane sulfonic acid (PFHpS) (CAS 375-92-8, EU 206-800-8) (RPF 1,3), Perfluorodecane sulfonic acid (PFDS) (CAS 335-
77-3, EU 206-401-9) (RPF 2), Perfluorotetradecanoic acid (PFTeDA) (CAS 376-06-7, EU 206-803-4) (RPF 0,3), Perfluorohexadecanoic acid (PFHxDA) (CAS 67905-19-5, EU
267-638-1) (RPF 0,02), Perfluorooctadecanoic acid (PFODA) (CAS 16517-11-6, EU 240-582-5) (RPF 0,02), Ammonium perfluoro (2-methyl-3-oxahexanoate) (HFPO-DA or
Gen X) (CAS 62037-80-3) (RPF 0,06), Propanoic Acid / Ammonium 2,2,3-trifluoro-3-(1,1,2,2,3,3-hexafluoro-3-(trifluoromethoxy)propoxy)propanoate (ADONA) (CAS
958445-44-8) (RPF 0,03), 2- (Perfluorohexyl)ethyl alcohol (6:2 FTOH) (CAS 647-42-7, EU 211-477-1) (RPF 0,02), 2-(Perfluorooctyl)ethanol (8:2 FTOH) (CAS 678-39-7, EU
211-648-0) (RPF 0,04) and Acetic acid / 2,2-difluoro-2-((2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl)oxy)- (c604) (CAS 1190931-41-9) (RPF 0,06).
(7
) The QS refers to the sum of the 24 PFAS listed in footnote 6 expressed as PFOA-equivalents based on the potencies of the substances relative to that of PFOA, i.e. the RPFs in
footnote 6.
(8
) ‘Total’ means the sum of all individual pharmaceuticals detected and quantified in the monitoring procedure, including relevant metabolites and degradation products.
(9
) Applicable to ‘data-poor substances’, i.e. ‘substances which are not data rich’
(10
) Applicable to ‘data-rich’ substances, i.e. substances where the QS can be derived from a species sensitivity distribution with an assessment factor of one, on the basis of chronic
and acute toxicity studies covering at least one species of algae, of invertebrates and of fish in fresh and saltwaters.
(11
) ‘Total’ means the sum of all data-poor or data-rich individual nrMs detected and quantified in the monitoring procedure.
187
Minimum list of pollutants and their indicators for which MS have to consider
establishing threshold values in accordance with Article 3 (ANNEX II to GWD)
1. Substances or ions or indicators which may occur both naturally and/or as a result of
human activities
Arsenic
Cadmium
Lead
Mercury
Ammonium
Chloride
Sulphate
Nitrites
Phosphorus (total)/Phosphates 111
2. Synthetic substances
Primidone
Trichloroethylene
Tetrachloroethylene
3. Parameters indicative of saline or other intrusions 112
Conductivity
111
MS may decide to establish threshold values either for phosphorus (total) or for phosphates.
112
With regard to saline concentrations resulting from human activities, MS may decide to establish threshold values either for sulphate and
chloride or for conductivity.
188
ANNEX 9: DETAILED ASSESSMENT OF IMPACTS PER POLICY OPTION
1. Surface water options
1.1. Option 1: Include each candidate priority substance individually and set
corresponding individual EQS
Option 1 provides the impact assessment for the addition of candidate substances to the
priority substance list individually with individual EQSs, with the caveat that PFAS will
be assessed as a group (due to the very large number of substances involved). The
assessment has been based on the EQS dossiers and monitoring data to derive a distance
to target, apply a dynamic baseline, and assess what measures might be needed to
achieve good chemical status. The distance to target can be relatively large (67-100%
expected exceedance), medium (33-66% expected exceedance) or small (0%-32%
expected exceedance).
Additionally, as part of the impact assessment consideration has been given to the
economic, environmental, and societal benefits of adding the identified candidates to the
priority list of substances. Where these are in balance with the costs, an addition to the
priority substance list is still worthwhile but that there is a closer balance between the
costs and benefits.
Based on this analysis the majority of substances fall into the first category where
benefits outweigh costs, which helps validate the prioritisation of substances in the first
instance. The neutral category is made up of a smaller set of substances (ibuprofen,
nicosulfuron, clothianidin, bisphenol A, and microplastics). As an example, the costs of
helping achieve good chemical status for bisphenol A are really very challenging, given
that source control alone is unlikely to be sufficient and that management of diffuse
sources as pathway disruption and end-of-pipe treatment will also be needed. However,
again, where bisphenol A has been identified to have endocrine disrupting effects for
both humans (particularly on childhood development), and aquatic species, and where the
monitoring data suggests the problem is widespread with a high level of exceedances
geographically (distance to target is large), there are very strong benefits to addressing
the issues. In this case it could be argued that managing bisphenol A is ‘high cost, high
benefit’, and therefore it belongs in the neutral category.
As silver is used in many products. Its antibacterial properties are driving many medical
applications, including e.g. silver-coated medical devices including urinary and vascular
catheters and for the treatment of burn wounds by silver containing creams and ointments
and by the application of silver sheets. Silver nanoparticles (nanosilver (NAg); are widely
produced and used nanoparticles thanks to their unique characteristics and diverse
antimicrobial mechanisms113
. Often, silver is one of few remaining available treatments
to protect the body for heavy bacterial infections. Numerous studies have demonstrated
the antimicrobial efficacy of NAg against many viral, fungal, parasitic, and bacterial
organisms114 115
. As a result, the healthcare sector is probably the largest market for NAg,
113
Silva, G. A. (2004). Introduction to nanotechnology and its applications to medicine. Surg. Neurol. 61, 216–220. doi:
10.1016/j.surneu.2003.09.036: https://pubmed.ncbi.nlm.nih.gov/14984987/
114
Rai, M., Deshmukh, S., Ingle, A., and Gade, A. (2012). Silver nanoparticles: the powerful nanoweapon against multidrug-resistant
bacteria. J. Appl. Microbiol. 112, 841–852. doi: 10.1111/j.1365-2672.2012.05253.x: https://pubmed.ncbi.nlm.nih.gov/22324439/
189
with nanoparticles being widely used as a coating agent in medical devices, such as
intravenous catheters, wound dressings, and organ/dental implants to inhibit bacterial
colonisation116 117
. Worryingly, NAg is also used into many ordinary consumer products,
like in household appliances, textiles /clothing, cosmetics, childcare products, food
packaging and containers118
.
The widespread use of NAg has raises concerns related to the rise of silver-resistant
bacteria 119
. Over several years, a multitude of studies describe the increasing resistance
in bacteria exposed to different forms of silver, including NAg. Silver resistance has been
reported in A. baumannii and many other important pathogenic bacteria 120 121 122 123 124
125
. Evidence also shows that NAg also promotes the co-emergence of antibiotic
resistance in bacteria126 127 128
. In combination with the fact that, in Europe, 6.5% of
patients in acute care hospitals develop at least one healthcare-associated infection129
thus
affecting millions of patients every year, is a worrying and challenging concern.
In this case the distance to target was identified as ‘medium’. While acknowledging that
the specific form of silver plays a key role in its bioavailability and impacts, it is also
undisputed that (surface) water is a pool/ reservoir of bacteria with various forms of
115
Ge, L., Li, Q., Wang, M., Ouyang, J., Li, X., and Xing, M. M. (2014). Nanosilver particles in medical applications: synthesis,
performance, and toxicity. Int. J. Nanomedicine 9, 2399–2407. doi: 10.2147/IJN.S55015: https://pubmed.ncbi.nlm.nih.gov/24876773/
116
Khan, I., Saeed, K., and Khan, I. (2017). Nanoparticles: properties, applications and toxicities. Arab. J. Chem. 2017, 1–24. doi:
10.1016/j.arabjc.2017.05.011: https://www.sciencedirect.com/science/article/pii/S1878535217300990?via%3Dihub
117
Rai, M., Yadav, A., and Gade, A. (2009). Silver nanoparticles as a new generation of antimicrobials. Biotechnol. Adv. 27, 76–83.
doi: 10.1016/j.biotechadv.2008.09.002: https://pubmed.ncbi.nlm.nih.gov/18854209/
118
State of the art in human risk assessment of silver compounds in consumer products: a conference report on silver and nanosilver
held at the BfR in 2012: https://pubmed.ncbi.nlm.nih.gov/23779146/
119
Gunawan, C., Teoh, W. Y., Marquis, C. P., and Amal, R. (2013). Induced adaptation of Bacillus sp. to antimicrobial nanosilver.
Small 9, 3554–3560. doi: 10.1002/smll.201300761: https://pubmed.ncbi.nlm.nih.gov/23625828/
120
Gupta, A., Matsui, K., Lo, J.-F., and Silver, S. (1999). Molecular basis for resistance to silver cations in Salmonella. Nat. Med. 5,
183–188. doi: 10.1038/5545: https://pubmed.ncbi.nlm.nih.gov/9930866/
121
Gunawan, C., Teoh, W. Y., Marquis, C. P., and Amal, R. (2013). Induced adaptation of Bacillus sp. to antimicrobial nanosilver.
Small 9, 3554–3560. doi: 10.1002/smll.201300761: https://pubmed.ncbi.nlm.nih.gov/28339182/
122
Muller, M., and Merrett, N. D. (2014). Pyocyanin production by Pseudomonas aeruginosa confers resistance to ionic silver.
Antimicrob. Agents Chemother. 58, 5492–5499. doi: 10.1128/AAC.03069-14: https://pubmed.ncbi.nlm.nih.gov/25001302/
123
Panáček, A., Kvítek, L., Smékalová, M., Večeřová, R., Kolář, M., Röderová, M., et al. (2018). Bacterial resistance to silver
nanoparticles and how to overcome it. Nat. Nanotechnol. 13, 65–71. doi: 10.1038/s41565-017-0013-y:
https://pubmed.ncbi.nlm.nih.gov/29203912/
124
Hosny, A. E.-D. M., Rasmy, S. A., Aboul-Magd, D. S., Kashef, M. T., and El-Bazza, Z. E. (2019). The increasing threat of silver-
resistance in clinical isolates from wounds and burns. Infect. Drug Resist. 2019, 1985–2001. doi: 10.2147/IDR.S209881:
https://pubmed.ncbi.nlm.nih.gov/31372006/
125
Valentin, E., Bottomley, A. L., Chilambi, G. S., Harry, E., Amal, R., Sotiriou, G. A., et al. (2020). Heritable nanosilver resistance
in priority pathogen: a unique genetic adaptation and comparison with ionic silver and antibiotic. Nanoscale 12, 2384–2392. doi:
10.1039/C9NR08424J: https://pubmed.ncbi.nlm.nih.gov/31930233/
126
Ma, Y., Metch, J. W., Yang, Y., Pruden, A., and Zhang, T. (2016). Shift in antibiotic resistance gene profiles associated with
nanosilver during wastewater treatment. FEMS Microbiol. Ecol. 92:fiw022. doi: 10.1093/femsec/fiw022:
https://pubmed.ncbi.nlm.nih.gov/26850160/
127
Chen, Q.-L., Zhu, D., An, X.-L., Ding, J., Zhu, Y.-G., and Cui, L. (2019b). Does nano silver promote the selection of antibiotic
resistance genes in soil and plant? Environ. Int. 128, 399–406. doi: 10.1016/j.envint.2019.04.061:
https://pubmed.ncbi.nlm.nih.gov/31078874/
128
Pietsch, F., O’Neill, A. J., Ivask, A., Jenssen, H., Inkinen, J., Kahru, A., et al. (2020). Selection of resistance by antimicrobial
coatings in the healthcare setting. J. Hosp. Infect. 106, 115–125. doi: 10.1016/j.jhin.2020.06.006:
https://pubmed.ncbi.nlm.nih.gov/32535196/
129
Widmer, A.F. et.al. Long-term antimicrobial effectiveness of Ag-impregnated foil on high-touch hospital surfaces... Antimicrobial
Resistance & Infection Control 2021, Vol. 10: https://aricjournal.biomedcentral.com/articles/10.1186/s13756-021-00956-1
190
antimicrobial resistance (AMR)130
. As a result, bacterial genes encoding for AMR can
easily maintain and spread through such reservoirs also to pathogenic bacteria. The
widespread over-use of silver also leads to the selection of silver resistant bacteria and
may be genotoxic to mammalian cells. Other reports indicate adverse effects of silver
nanoparticles on reproduction of experimental animals, as well as neurotoxic effects on
cognitive functions131
.
The cost for the removing silver from effluents via UWWTPs is considerable (source
control could include pre-treatment or onsite wastewater treatment by reverse osmosis
(RO) prior to direct discharges or releases to sewer), amounting to an estimated cost of
0.1% of the industry’s annual turnover132
. Alternatively, urban wastewater treatment
plants would need to invest in reverse osmosis to clean such effluents. Assuming that
between 1-5% UWWTPs would have to deploy reverse osmosis, costs for EU taxpayers
would be between €2,184,600 and €109,230,000. The benefits of removing silver to
reduce the risk for AMR and other risks, similar to the benefits of reducing AMR from
antibiotics, are also large. In 2014, it was estimated that infection from antibiotic-
resistant / multi-drug resistant bacteria in the United States resulted in a loss of over $20
billion in direct economic costs, and $35 billion through decline in societal
productivity133134
, adding up to a total of $55 billion, which corrected for inflation would
result in 63 billion in 2021135
. In 2021 this would translate to costs of $0,19 billion per
million inhabitants136
. Assuming comparability in US and EU rates of AMR and their
related avoided costs / benefits this translates to €84 billion of EU wide AMR-related
avoided costs (benefits)137
. When assuming that the benefits of reducing silver related
AMR would amount to between 50% to 100% of the AMR costs for antibiotics, this
translates to EU-benefits of between €42 to €84 billion.
Where there are multiple sources and pathways to environment including mine drainage,
manufacturing, use of products, run-off, end-of-pipe treatment, it means that a very
targeted plan of action will be needed on a Member State by Member State basis. This
makes judging the actual costs per Member State challenging, but it can be reasoned that
where the issue will need to tackle both point source and diffuse emissions the package
of measures will need to be comprehensive, and therefore likely balance the benefits
identified.
130
Gunawan, C. et.al. Widespread and Indiscriminate Nanosilver Use: Genuine Potential for Microbial Resistance. ACS Nano, 2017
Apr 25;11(4):3438-3445. Doi: 10.1021/acsnano.7b01166. Epub 2017 Mar 24. https://pubmed.ncbi.nlm.nih.gov/28339182/
131
Anna Maria Świdwińska-Gajewska, Sławomir CzerczakNanosilver - harmful effects of biological activity:
https://pubmed.ncbi.nlm.nih.gov/25902699/
132
An extrapolation of the RO costs based on the number of EU non-ferrous metals production facilities 847132
in 2019, assuming that
around 5% - 10% of effluents need treatment, would potentially result in EU wide costs ranging from €423,500 to €8,470,000. In
relation to the annual turnover of the EU non-ferrous metals industry (120 billion132
) this would equal 0.1%.
133
Zhen, X., Lundborg, C. S., Sun, X., Hu, X., and Dong, H. (2019). Economic burden of antibiotic resistance in ESKAPE organisms:
a systematic review. Antimicrob. Resist. Infect. Control 8:137. doi: 10.1186/s13756-019-0590-7:
https://pubmed.ncbi.nlm.nih.gov/31417673/
134
Golkar, Z., Bagasra, O., and Pace, D. G. (2014). Bacteriophage therapy: a potential solution for the antibiotic resistance crisis. J.
Infect. Dev. Ctries. 8, 129–136. doi: 10.3855/jidc.3573: https://pubmed.ncbi.nlm.nih.gov/24518621/
135
https://www.in2013dollars.com/us/inflation/2014?endYear=2021&amount=55
136
In 2021 the number of US inhabitant was 332 million: https://www.worldometers.info/world-population/us-population/
137
No. of EU inhabitants in 2021: 447 million (https://european-union.europa.eu/principles-countries-history/key-facts-and-
figures/life-eu_en)
191
Option 1 has assessed the candidate substances as individual additions. Further
discussion on the possible application of grouping strategies is further covered in Option
2.
192
Table A9.1: Surface water option 1 – summary of impacts
Substance
Dista
nce
to
targe
t
Environmental
impact
Economic Impact
Social impact
Overall
balance of
costs and
benefits
Cost Benefits
Estrone
E1
Medi
um
Chronic
ecosystem level
impacts from
exposure to
hormones and
EDC effects can
be avoided.
Some potential for
source control and end-
of-pipe treatment. Costs
look broadly
comparable with risk.
Potential avoided
environmental
impacts and human
health via exposure
through
environment.
Ecosystem benefits,
included health of
aquaculture and
fishing.
Societal benefits
from greater
health
protections,
food security,
and ecosystem
services.
The benefits of
addition to the
PS list
outweigh the
costs.
17- Beta
estradiol
(E2)
Medi
um
Chronic
ecosystem level
impacts from
exposure to
hormones and
EDC effects can
be avoided.
Some potential for
source control and
end-of-pipe
treatment. Costs
look broadly
comparable with
risk.
Potential avoided
environmental impacts
and human health via
exposure through
environment.
Ecosystem benefits,
included health of
aquaculture and
fishing.
Societal
benefits from
greater health
protections,
food security,
and ecosystem
services.
The benefits of
addition to the
PS list
outweigh the
costs.
Ethinyl
estradiol
(EE2)
Larg
e
Environmental
impacts for aquatic
species likely
stronger than the
other two
estrogenics, with
clear benefits for
avoided impacts.
The EQSD dossier
indicates risk of
potential
biodiversity
impacts from
concentrations
above the EQS.
Cost of management
would be challenging
requiring a basket of
measures likely at
higher costs.
Impacts on
pharmaceutical
industries if use is
restricted / banned,
and limited options
for chemical
alternatives.
Potential avoided
environmental impacts
and human health via
exposure through
environment.
Ecosystem benefits,
included health of
aquaculture and
fishing.
Societal
benefits from
avoided health
impacts
relating to
EDC and
carcinogen
effects.
Possible
societal
impacts from
loss of use
(contraceptive
pill, HRT,
hormone
treatments if
restricted/bann
ed).
The benefits of
addition to the
PS list
outweigh the
costs.
Azithromy
cin
Medi
um
Primary concerns
relate to build up of
antibiotics within
the environment
leading to anti-
microbial resistance
(AMR).
Potential
toxicological
effects at elevated
doses, likely to be
site specific / hot-
spots dependent on
releases.
Very limited selection
of alternatives, loss of
macrolide antibiotics
through restriction
would lead to
increased healthcare
costs.
Largely end of pipe
measures only. But
Ozonation is effective
and costs already
captured by
Forthcoming revised
UWWT Directive.
Avoid costs to
healthcare from
protections against the
development of AMR
within health settings.
Protection
against AMR
has clear
societal
benefits.
The benefits of
addition to the
PS list outweigh
the costs.
Clarithro
mycin
Smal
l
The benefits of
addition to the
PS list outweigh
the costs.
Erythromy
cin
Smal
l
The benefits of
addition to the
PS list outweigh
the costs.
Diclofena
c
Larg
e
Highlighted as one
of the highest
concern
pharmaceuticals for
environmental
impacts. Potential
toxic effects on
avian populations
via surface water
Source control options
look viable (range of
alternatives); end-of-
pipe measures could
also be considered to
address risks. Note
possible economic costs
on pharmaceutical
industry if
Economic benefits for
aquaculture from
improved food quality.
Improved ecosystem
services from
protection of the
aquatic environment.
Societal
impacts from
loss of use
/restricted use
if controls
implemented.
Additional
costs for
society on
The benefits of
addition to the
PS list outweigh
the costs.
193
Substance
Dista
nce
to
targe
t
Environmental
impact
Economic Impact
Social impact
Overall
balance of
costs and
benefits
Cost Benefits
species. restricted/banned but
expect production to
switch to alternatives.
willingness to
pay and
advanced
WWTWs.
Carbamaz
epine
Larg
e
Population effects
for aquatic species
through impacts on
fertility and
reproduction
(particularly
crustaceans).
Source control options
look viable (range of
alternatives although
care needed as patient-
to-patient viability is
unclear); while end-of-
pipe measures could
also be considered to
address risks. Note
possible economic costs
on pharmaceutical
industry if
restricted/banned but
expect production to
switch to alternatives.
Economic benefits for
aquaculture from
improved food quality.
Improved ecosystem
services from
protection of the
aquatic environment.
Societal
impacts from
loss of use
/restricted use
if controls
implemented.
Additional
costs for
society on
willingness to
pay and
advanced
WWTWs.
The benefits of
addition to the
PS list outweigh
the costs.
Ibuprofen
Medi
um
High volume use,
with potential toxic
effects for some
aquatic species.
This includes
fertility effects
(hormone levels) in
fish.
Potential impacts from
restriction/increased
control of use.
Including economic
costs for manufacturers
and retailers as
alternatives are more
expensive. WWTWs
options more
challenging and likely
costly.
Economic benefits for
aquaculture from
improved food quality.
Improved ecosystem
services from
protection of the
aquatic environment.
Societal cost
from
loss/restriction
of ibuprofen
and increased
costs for other
types of
medicine.
Including
prescription
only
medications.
Benefits and
costs assessed as
neutral.
(Medium cost /
Medium
benefit)
Nicosulfur
on
Smal
l
Nicosulfuron has
aquatic toxicity
(particularly to
flora) and concerns
over
carcinogenicity as a
secondary
poisoning issue.
Environmental
concentrations in
decline over the last
five years.
Primarily intervention
relates to source control
and pathway disruption.
Chemical alternatives
are available and in use
(primarily glyphosate).
Pathway disruption
costs are balanced with
the risks.
Economic benefits for
aquaculture from
improved food quality.
Improved ecosystem
services from
protection of the
aquatic environment.
Societal
benefit from
protection of
exposure and
secondary
poisoning
action as a
potential
carcinogen.
Benefits and
costs assessed as
neutral.
(Small cost /
small benefit)
Acetamipr
id
Smal
l
Toxic aquatic
effects against
invertebrates,
arthropods, and
crustaceans. Wider
environmental
concerns for
terrestrial
pollinators.
Wide-range of
alternatives and options
for source control,
including biocidal use.
Pathway disruption
costs look reasonable
based on the scale of
exceedance. End-of-
pipe would require
GAC, which is costly.
Impacts for
manufacturers, farmers,
wastewater companies,
and general public.
Avoided drinking
water treatment costs.
Economic benefits for
aquaculture from
improved food quality.
Avoided economic
impacts for agriculture
(pollinators).
Avoided
human health
impacts from
exposure to
Neonicotinoids
.
The benefits of
addition to the
PS list outweigh
the costs.
Clothianid
in
Smal
l
Toxic aquatic
effects against
invertebrates,
arthropods, and
crustaceans. Wider
Use as pesticide has
ceased. Use as biocide
ongoing. Pathway
disruption costs may be
significant. End-of-pipe
Avoided drinking
water treatment costs.
Economic benefits for
aquaculture from
improved food quality.
Avoided
human health
impacts from
exposure to
Neonicotinoids
Benefits and
costs assessed as
neutral.
(Small cost /
small benefit)
194
Substance
Dista
nce
to
targe
t
Environmental
impact
Economic Impact
Social impact
Overall
balance of
costs and
benefits
Cost Benefits
environmental
concerns for
terrestrial
pollinators.
technologies based on
Ozonation. Costs could
be considerable to
manage run-off from
biocidal use in field.
Avoided economic
impacts for agriculture
(pollinators).
.
Imidaclop
rid
Medi
um
Toxic aquatic
effects against
invertebrates,
arthropods, and
crustaceans. Wider
environmental
concerns for
terrestrial
pollinators.
No use as a pesticide,
but ongoing use as a
biocide including
veterinary use for
animals and domestic
pets. Limited chemical
alternatives, more
significant cost and
effort for source control
or end-of-pipe.
Avoided drinking
water treatment costs.
Economic benefits for
aquaculture from
improved food quality.
Avoided economic
impacts for agriculture
(pollinators).
Avoided
human health
impacts from
exposure to
Neonicotinoids
.
Societal
impacts for
domestic pets
if use is
restricted.
The benefits of
addition to the
PS list outweigh
the costs.
Thiaclopri
d
Smal
l
Toxic aquatic
effects against
invertebrates,
arthropods, and
crustaceans. Wider
environmental
concerns for
terrestrial
pollinators.
Environmental
concentrations look
stable despite use
ceasing. Some use
issues with emergency
authorisations. Multiple
chemical alternatives
and options to manage
as source control in a
cost-effective fashion.
Avoided drinking
water treatment costs.
Economic benefits for
aquaculture from
improved food quality.
Avoided economic
impacts for agriculture
(pollinators).
Avoided
human health
impacts from
exposure to
Neonicotinoids
.
The benefits of
addition to the
PS list outweigh
the costs.
Thiametho
xam
Smal
l
Toxic aquatic
effects against
invertebrates,
arthropods, and
crustaceans. Wider
environmental
concerns for
terrestrial
pollinators.
No pesticide approval
but use as a biocide.
Limited options for
source control. pathway
disruption not relevant.
End-of-pipe would
require GAC advanced
treatment, likely to be
costly.
Avoided drinking
water treatment costs.
Economic benefits for
aquaculture from
improved food quality.
Avoided economic
impacts for agriculture
(pollinators).
Avoided
human health
impacts from
exposure to
Neonicotinoids
.
The benefits of
addition to the
PS list outweigh
the costs.
Bifenthrin
Larg
e
Highly toxic to the
aquatic
environment even
at low
concentrations.
Possible risk of
population level
impacts.
Limited chemical
alternatives, meaning
restriction / ban
would likely mean
loss of crop yield, or
implementation of
integrated crop
management.
Measures linked to
source control and
pathway disruption,
with the latter set of
measures carrying
significant cost given
distance to target.
Avoided drinking
water treatment costs.
Economic benefits for
aquaculture from
improved food quality.
Avoided economic
impacts for agriculture
(pollinators).
Avoided
human health
impacts where
these
substances are
identified as
EDC. Avoided
impacts on
pollinators.
Possible food
security issues
if loss of use
without
chemical/non-
chemical
alternatives in
place.
The benefits of
addition to the
PS list outweigh
the costs.
Deltameth
rin
Larg
e
Highly toxic to the
aquatic
environment even
at low
concentrations.
Possible risk of
population level
impacts.
Use as both pesticide
and biocide. Limited
chemical alternatives,
meaning restriction /
ban would likely mean
loss of crop yield, or
implementation of
integrated crop
management. Will need
a package of measures
Avoided drinking
water treatment costs.
Economic benefits for
aquaculture from
improved food quality.
Avoided economic
impacts for agriculture
(pollinators).
Avoided
human health
impacts where
these
substances are
identified as
EDC. Avoided
impacts on
pollinators.
Possible food
The benefits of
addition to the
PS list outweigh
the costs.
195
Substance
Dista
nce
to
targe
t
Environmental
impact
Economic Impact
Social impact
Overall
balance of
costs and
benefits
Cost Benefits
source control, pathway
disruption and end-of-
pipe. Costs likely to be
significant.
security issues
if loss of use
without
chemical/non-
chemical
alternatives in
place.
Esfenvaler
ate
Larg
e
Highly toxic to the
aquatic
environment even
at low
concentrations.
Possible risk of
population level
impacts.
Limited chemical
alternatives, meaning
restriction / ban would
likely mean loss of crop
yield, or
implementation of
integrated crop
management. Measures
linked to source control
and pathway disruption,
with the latter set of
measures carrying
significant cost given
distance to target.
Avoided drinking
water treatment costs.
Economic benefits for
aquaculture from
improved food quality.
Avoided economic
impacts for agriculture
(pollinators).
Avoided
human health
impacts where
these
substances are
identified as
EDC. Avoided
impacts on
pollinators.
Possible food
security issues
if loss of use
without
chemical/non-
chemical
alternatives in
place.
The benefits of
addition to the
PS list outweigh
the costs.
Permethri
n
Larg
e
Highly toxic to the
aquatic
environment even
at low
concentrations.
Possible risk of
population level
impacts.
Use as both pesticide
and biocide. Limited
chemical alternatives,
meaning restriction /
ban would likely mean
loss of crop yield, or
implementation of
integrated crop
management. Will need
a package of measures
source control, pathway
disruption and end-of-
pipe. The end-of-pipe
options likely to be
limited and costly (PAC
advanced treatment)
Overall costs likely to
be significant.
Avoided drinking
water treatment costs.
Economic benefits for
aquaculture from
improved food quality.
Avoided economic
impacts for agriculture
(pollinators).
Avoided
human health
impacts where
these
substances are
identified as
EDC. Avoided
impacts on
pollinators.
Possible food
security issues
if loss of use
without
chemical/non-
chemical
alternatives in
place.
The benefits of
addition to the
PS list outweigh
the costs.
Glyphosat
e
Larg
e
Potential harm to
aquatic
environments given
the very high usage
rates and risks for
loss to water,
including non-
target aquatic flora.
Exceedance rate
based on potential
EQS was high.
Range of alternatives
available, although
likely more costly.
Source control and
pathway disruption
measures likely needed
will be costly.
Avoided health
impacts related to very
wide use and drinking
water. Avoided costs
of water treatment for
use as both drinking
water and agriculture
use.
Protection of
drinking water
would be a key
societal benefit
given usage
rates of
glyphosate.
Avoided
health impacts
will be key.
The benefits of
addition to the
PS list outweigh
the costs.
Triclosan
Medi
um
Toxic for aquatic
organisms
(particularly larvae
and fish eggs).
Effects identified
on a range of
aquatic species
including
amphibians. Some
Intervention is either as
source control or end-
of-pipe. Use as a
biocidal agent in soaps.
Some alternatives and
options for direct source
control. End-of-pipe
advanced treatment
likely costly.
Avoided costs of
drinking water
treatment. Economic
benefits for
aquaculture from
improved food quality
Avoided
health impacts
for human
health via
exposure.
The benefits of
addition to the
PS list outweigh
the costs.
196
Substance
Dista
nce
to
targe
t
Environmental
impact
Economic Impact
Social impact
Overall
balance of
costs and
benefits
Cost Benefits
evidence of anti-
microbial resistance
issues.
PFAS
Larg
e
Widespread and
very long-lasting
environmental
effects. PFAS
dubbed ‘forever
chemicals’ with
good reason.
Complex issue likely
needing an integrated
basket of measures at
all stages of life-cycle.
Costs are likely to be
very significant.
Primarily avoided
health costs from
chronic exposure to
pathway. Avoided
environmental impacts
with benefits for
aquaculture, and
farming.
Health
concerns are
well founded
with human
biomonitoring
data
highlighting
societal
impacts that
need to be
minimised.
The benefits of
addition to the
PS list outweigh
the costs.
Bisphenol
A
Larg
e
Population level
effects as an
endocrine
disrupting
chemical for
aquatic organisms.
Multiple uses and
pathways to
environment. Major
issue is manufacture
and use of epoxy resins
and losses from
polycarbonate and PVC
articles. Package of
measures needed as
source control, pathway
disruption and end-of-
pipe. Diffuse sources
problematic and costs
of achieving
compliance likely very
significant.
Avoided costs of
drinking water
treatment. Avoided
environmental impacts
for aquaculture.
Innovation for
development of
alternative chemicals
and technologies.
Avoided
health impacts
from exposure.
Benefits from
protection of
aquatic
environment
as ecosystem
services.
Benefits and
costs assessed as
neutral.
(High cost /
high benefit)
Microplast
ics
Not
asses
sed
Chronic ecosystem
level effects from
physical and
pathological
impacts of micro-
plastics for aquatic
species and
accumulation at
higher trophic tiers.
Primary source is for
secondary
microplastics are
brake and tyre wear,
emissions to sewer
from laundry
activities, land
spreading for sludges.
Management via
pathway disruption
and end-of-pipe likely
to be costly.
Avoided costs of
drinking water
treatment. Avoided
environmental impacts
for aquaculture.
Innovation for
development of
alternative chemicals
and technologies.
Benefits from
protection of
aquatic
environment
as ecosystem
services.
Benefits and
costs assessed as
neutral.
(High cost /
high benefit)
Silver
Medi
um
Chronic aquatic
toxicity effects,
primarily for
crustaceans.
Nanoform of silver
is the primary issue.
Ionic form of silver
is most probably
the primary issue.
Multiple pathways
and sources to
environment with a
package of measures
spanning source
control, pathway
disruption, and end-
of-pipe needed to help
achieve compliance.
Given the ‘small’
distance to target
would expect
prioritisation of
sources nationally.
Avoided
environmental impacts
for human health
(water can be the
reservoir of bacteria
resistant to the silver
due to the presence of
silver as pressure) and
aquaculture.
Innovation for
development of
alternative chemicals
and technologies.
Benefits from
avoided health
impacts e.g.
resulting from
exposure to
bacteria that
are co-resistant
to the
antibiotics and
silver together
(since they
share the same
mechanism of
the resistance).
No societal
impacts
identified.
Benefits and
costs assessed as
neutral.
(High cost /
high benefit)
Costs outweigh
the benefits of
addition
197
Table A9.2: Examples of monetized impacts for surface water Option 1
Environmental impact Economic Impact Social impact
Avoided/reduced environmental
impacts and potential toxic effects on
aquatic species. E.g. Carbamazepine
has population effects for aquatic
species through impacts on fertility
and reproduction (particularly
crustaceans). Silver also has chronic
aquatic toxicity effects, primarily for
crustaceans. Ibuprofen exhibits
potential toxic effects for some
aquatic species including fertility
effects (hormone levels) in fish while
nicosulfuron has aquatic toxicity
(particularly to flora) and concerns
over carcinogenicity as a secondary
poisoning issue. Diclofenac is one of
the highest concern pharmaceuticals
for environmental impacts with
potential toxic effects on avian
populations via surface water species.
Estrone E1, 17- Beta estradiol (E2),
Ethinyl estradiol (EE2) are associated
with chronic ecosystem level impacts
from exposure to hormones and
EDC. PFAS has a widespread and
very long-lasting environmental
effects while Bisphenol A causes
population level effects as an
endocrine disrupting chemical for
aquatic organisms. Triclosan is toxic
for aquatic organisms particularly
larvae and fish eggs with effects
identified on a range of aquatic
species including amphibians.
Acetamiprid, Clothianidin,
Imidacloprid, Thiacloprid,
Thiamethoxam Bifenthrin,
Deltamethrin Esfenvalerate and
Permethrin are associated with toxic
aquatic effects against invertebrates,
arthropods, and crustaceans with
wider environmental concerns for
terrestrial pollinators (with
Bifenthrin, Deltamethrin
Esfenvalerate, Permethrin being
highly toxic to the aquatic
environment even at low
concentrations). Glyphosate is
associated with potential harm to
aquatic environments given the very
high usage rates and risks for loss to
water, including non-target aquatic
flora.
Microplastics: chronic ecosystem
level effects from physical and
pathological impacts of micro-
plastics for aquatic species and
accumulation at higher trophic tiers.
Primary source for secondary
microplastics are brake and tyre
wear, emissions to sewer from
laundry activities, land spreading for
sludges.
Significant costs to ensure compliance with proposed EQS for
Ethinyl estradiol (EE2), Ibuprofen, Clothianidin, Imidacloprid,
Thiamethoxam, Bifenthrin, Deltamethrin, Esfenvalerate, Permethrin,
Glyphosate, Triclosan, PFAS and Bisphenol A implementing a range
of source control, pathway disruption, targeted end of pipe treatment
measures. E.g. the cost of a take-back scheme for unused
pharmaceuticals in France is €10 million. The 2022 Annex XV
restriction report for the proposed restriction of PFASs in firefighting
foams estimates that the ban is estimated to cost society €6.8 billion
over a 30-year period or €390 million per year. Costs of pathway
disruption measures (e.g. buffer strips) is €472 million per year for
pharmaceuticals; for pesticides these range from €162 million for
clothianidin and imidacloprid to €285 million for glyphosate.
Wastewater treatment range is €10- €32 per population equivalent,
per annum (technology dependent). For instance, use of GAC at 20%
of UWWTPs at or above 50,000 P.E. would equate to annualised
costs of €2 billion per year (25 year lifetime) and would close
distance to target for Thiamethoxam.
Silver: Multiple pathways and sources to environment with a
package of measures spanning source control (abatement upgrades,
restricted use, capture and treat for mine drainage), pathway
disruption (estimated as €103 million per annum), and end-of-pipe
(estimated as €2.5 billion per annum for reverse osmosis in 33% of
all UWWTPs serving ≥50K P.E.) needed to help achieve
compliance.
Moderate/Small costs to ensure compliance for Estrone E1, 17-
Beta estradiol (E2), Diclofenac, Carbamazepine, Azithromycin,
Clarithromycin, Erythromycin, Acetamiprid, Thiacloprid,
Nicosulfuron due to small distance to target, availability of source
control and pathway disruption measures and/or positive impact of
forthcoming revision of the UWWTD on quaternary end of pipe
treatment. E.g. costs of pathway disruption measures (e.g. buffer
strips) for pesticides range from €1.6 million for acetamiprid to
€12.8 million for nicosulfuron. Wastewater treatment cost range is
€10- €20 per population equivalent, per annum (technology
dependent). For instance, use of ozonation on all UWWTPs at or
above 50,000 P.E. would equate to annualised costs of €318 million
per year (25 year lifetime) and would close distance to target for
Estrone E1, 17- Beta estradiol (E2), Azithromycin, Clarithromycin,
Erythromycin, Diclofenac, Carbamazepine.
Monitoring costs: range from €11-100 per sample for all substances
except for PFAS. For PFAS analytical costs are up to €250 per
sample.
Avoided/reduced impacts on pollinators and agriculture
(Acetamiprid, Clothianidin, Imidacloprid, Thiacloprid,
Thiamethoxam, Bifenthrin, Deltamethrin Esfenvalerate, Permethrin).
E.g. across Europe, crop pollination by insects accounted for
approximately €14.6 billion annually.
Economic benefits for aquaculture from improved food quality
(Estrone E1, 17- Beta estradiol (E2), Ethinyl estradiol (EE2),
Acetamiprid, Clothianidin, Imidacloprid, Thiacloprid,
Thiamethoxam Bifenthrin, Deltamethrin Esfenvalerate, Permethrin,
Diclofenac, Carbamazepine, ibuprofen, Nicosulfuron, triclosan,
PFAS, bisphenol A).
Avoided costs of water treatment for drinking water, agriculture and
industry (Acetamiprid, Clothianidin, Imidacloprid, Thiacloprid,
Thiamethoxam Bifenthrin, Deltamethrin Esfenvalerate, Permethrin,
glyphosate, triclosan, bisphenol A, PFAS, microplastics) (in the case
of source control and pathway disruption measures). E.g. in 2015,
approximately €0.5 billion was spent annually to remove pesticides
in wastewater treatment plants (WWTP) in Europe.
Innovation for development of alternative chemicals and
technologies (e.g. Bisphenol A).
Avoided/reduced human health impacts
from Glyphosate, Triclosan, PFAS,
Bisphenol A via reduced exposure
through drinking water (Bisphenol A is
associated with childhood obesity
which could cost the EU around €1.8
billion); from Neonicotinoids
(Acetamiprid, Clothianidin,
Imidacloprid, Thiacloprid,
Thiamethoxam), EDC (Bifenthrin,
Deltamethrin Esfenvalerate,
Permethrin, EE2) and (potential)
carcinogenic effects (Ethinyl estradiol
(EE2), Nicosulfuron). E.g. Annual costs
related to endocrine disruptors exposure
were estimated to be €163 billion. This
is due to the fact that endocrine
disruptors in Europe contribute
substantially to neurobehavioral deficits
and disease, with a high probability of
>€150 billion costs annually as well as
childhood obesity which costs €1.54
billion annually.
Protection against AMR has clear
societal benefits and avoided costs to
healthcare from protections against the
development of AMR within health
settings (Azithromycin, Clarithromycin,
Erythromycin). E.g. It is estimated that
AMR costs the EU €1.5 billion per year
in healthcare costs and productivity
losses.
Specific to PFAS the annual health
expenditure due to kidney cancer
caused by PFAS exposure estimated to
be €12.7 to €41.4 million in the EEA
countries. The study also estimated
around €10.7 to €35 billion of annual
health costs due to hypertension
brought about by background exposure
(exposed via consumer products,
background levels).
Possible societal impacts from loss of
use (contraceptive pill, HRT, hormone
treatments if Ethinyl estradiol (EE2) is
restricted/banned.
Societal impacts from loss of use
/restricted use of Diclofenac,
Carbamazepine, Ibuprofen if controls
implemented and increased costs for
other types of medicine (including
prescription only medications).
Possible food security issues if loss of
use without chemical/non-chemical
alternatives in place (Bifenthrin,
Deltamethrin, Esfenvalerate,
Permethrin).
Societal impacts for domestic pet
owners if use of Imidalcoprid is
restricted.
Increased prices of goods and services
as a result of source control measures.
198
1.2. Option 2: Include candidate PS as groups of substances where appropriate.
Set corresponding EQS using markers or the sum of substance
concentrations in the case of groups.
The second option also focusses on the candidate substances to add to the PS list, but as
groups. There can be good reasons to rationally consider the possibility of using grouping
approaches when adding substances to the priority substance list. This option identified four
possible groups – estrogenic hormones, macrolide antibiotics, neonicotinoid pesticides,
pyrethroid pesticides (noting that the addition of PFAS as a group has already been confirmed
and included as part of Option 1).
Table A9.3 provides the outcome of the impact assessment and balance of costs and benefits.
There are a series of metrics which can strengthen of weaken the argument for whether a
grouping approach is sensible and adds value to the way that the substances are managed.
Based on the analysis of these metrics three out of the four possible grouping approaches
(estrogens, neonicotinoids, and pyrethroids) have multiple problems which mean that in the
balance of costs and benefits a grouping approach is not recommended.
The final possible grouping (macrolide antibiotics) showed a great deal of benefits for using a
grouping approach, with the one major issue being the variation in potency. In this case the
proposed EQS values vary significantly (Azithromycin AA and MAC 0.019 µg/L;
Clarithromycin AA and MAC 0.13 µg/L; Erythromycin AA and MAC 0.5 µg/L). In this case
the use of a relative potency factor (RPF) approach (similar to what has been proposed for
PFAS) aligned to the equivalency of azithromycin could warrant further investigation. If this
proved not possible/unfruitful, the variations in potency would suggest a single EQS entry
would be unwise.
Table A9.3: Surface water option 2 – summary of impacts
Substance
group
Environmental
impacts
Economic impacts
Social impacts
Overall balance
of costs and
benefits
Cost Benefit
Estrogenic
hormones
Possible
incoherence issues
linked to difference
in potency.
Incoherence issues
could affect
measure selection
and negative cost
impacts.
More consistent
approach to
managing selection
of alternatives and
substitution where
needed.
Lack of granular
data for E1, E2,
EE2 in aquatic
environment could
lead to less
effective
management with
negative societal
consequences.
The potential
costs outweigh
the benefits.
Grouping not
recommended
Macrolide
antibiotics
Greater coherence
in the approach to
AMR if grouped.
Azithromycin has a
greater distance to
target, if grouped,
would measures
have to work to the
worst member
substance (i.e.,
greater
unnecessary cost?)
Correlation on use,
pathway to
environment and
measures, could
mean cost savings is
managed as a group.
Greater coherence
in the approach to
AMR if grouped.
Benefits could
outweigh costs.
But variation in
potency an issue
for investigation.
Neonicoti-
noids
Greater coherence
in the approach to
protection of
pollinators if
grouped.
Variations in use,
pathways, and
measures.
Grouping could
create incoherence
in measures and
No economic
benefits identified.
Greater coherence
in the approach to
protection of
pollinators if
grouped.
The potential
costs outweigh
the benefits.
Grouping not
recommended.
199
unnecessary costs.
Pyrethroids
Uses and pathways
to environment
vary. Grouping
could create
coherence issues
that would
negatively impact
environmental
protections.
Loss of granular
(substance by
substance) data
impacts measure
selection and
effectiveness of
measures.
Very limited
alternatives,
grouping approach
could mean a more
holistic approach
avoiding regrettable
substitution and
associated costs.
No costs or
benefits identified.
The potential
costs outweigh
the benefits.
Grouping not
recommended.
1.3. Option 3: Revise EQS where necessary based on new scientific data for
existing PS.
Option 3 is based on the fact that the scientific data available has evolved since the original
analysis and risk assessment for pre-existing EQS values. Where the proposed EQS
amendments reflect a robust and thorough investigation of the new and emerging science to
re-appraise the EQS values it can be expected that the proposed amendments already reflect
environmental benefits to address the risks more appropriately. Equally where the proposed
EQS amendments also include a relaxation of the thresholds where the existing threshold is
deemed overly cautious, it is possible to see that there would also be economic benefits in the
fact that measures may no longer be needed and the resources can be reallocated in a more
effective fashion to target other issues.
The impact assessment has also recognised that for pre-existing EQS substances, there will be
a distance to target based on the current situation (baseline) and based on the proposed EQS
the distance target may remain unchanged, get bigger, or get smaller. Table A6.5 provides the
results of this impact assessment. Similarly, to option 1 the relative balance of costs and
benefits resulted in three possible outcomes - it has been possible for the benefits to outweigh
the costs, the costs to outweigh the benefits, and the costs and benefits being balanced (i.e. a
neutral result).
For the majority of the substances targeted for amendment of EQS the benefits outweigh the
costs, either through greater environmental protections, or more accurate EQS allowing
suitable prioritisation of risks and measures. For a smaller set of substances, the impact
assessment draws a neutral result (chlorpyrifos, cypermethrin, mercury, nickel, and PAHs).
This is because the revised EQS is significantly more stringent and will determine new
measures are likely needed to help achieve good chemical status. However, based on the new
risk assessment it can also be determined that the risks to date have been underestimated, and
therefore the additional effort is warranted.
Based on the analysis of substances in the neutral category, the most uncertain will be nickel.
The proposed EQS amendment is likely to create a new wave of exceedances, with
potentially an extensive package of measures needed to achieve good chemical status. Given
the potential uncertainties involved, this may be the one substance where, depending on the
specific measures implemented, the costs outweigh the benefits. However, the margins in this
case are very tight and overall, the impact assessment assesses that the balance of costs and
benefits will be neutral.
200
Table A9.4: Surface water option 3 – summary of impacts
Substa
nce
Distan
ce to
target
*
Environmenta
l impact
Economic Impact
Social
impact
Overall balance of
costs and benefits
Cost Benefits
Chlorp
yrifos
Mediu
m
Updated EQS
based on new
science and re-
appraisal of risk,
would provide
more appropriate
protections.
The proposed EQS is
considerably lower than
the existing one. Possible
additional analytical costs.
Where Chlorpyrifos is no
longer approved, measures
will likely target diffuse
sources and legacy issues.
Potential additional costs.
Limited
economic
benefits
identified.
Possible
advances in
analytical
techniques
could bring
down the cost of
analysis over
time.
Improved
protections
for human
health.
Particularly
given the
recent
nomination
as a POP and
issues
around
bioaccumula
tion.
Based on the review
and reappraisal of
EQS additional
measures may be
warranted. Costs are
considered
proportionate to the
addressed risks.
Option assessed as
neutral
(Medium cost /
medium benefit)
Cyper
methri
n
Mediu
m
Updated EQS
based on new
science and re-
appraisal of risk,
would provide
more appropriate
protections.
Proposed EQS is more
stringent. May need
additional measures
targeting timber treatment,
including in-use stocks.
Costs likely significant.
Avoided health
costs for
aquaculture and
ecosystem
services.
Improved
environment
al
protections
for
ecosystem
services.
Based on the review
and reappraisal of
EQS additional
measures may be
warranted. Costs are
considered
proportionate to the
addressed risks.
Option assessed as
neutral
(Medium cost /
medium benefit)
Dicofol Small
Updated EQS
based on new
science and re-
appraisal of risk,
would provide
more appropriate
protections.
Proposed EQS is more
stringent, but only a minor
alteration to AA and biota.
No expected additional
costs.
Proposed EQS is
more stringent,
but only a minor
alteration to AA
and biota. No
expected
additional
economic
benefits.
No social
impacts
identified.
On the basis that new
scientific evidence has
been used to re-assess
the EQS and no/limited
impacts identified.
Amendment is
preferrable.
Diuron
Mediu
m
Updated EQS
based on new
science and re-
appraisal of risk,
would provide
more appropriate
protections.
Proposed EQS is
significantly more
stringent. Use as a
pesticide and biocide has
ceased. Additional
measures likely to address
industrial uses as
restrictions / improved
abatement. Also legacy
issues from contaminated
sites.
Potential
innovation
opportunity to
remove use as an
intermediate in
manufacture of
rubber products.
Improved
human
health
protections
given diuron
is an EDC.
On the basis that new
scientific evidence has
been used to re-assess
the EQS and risks
understated. The
benefits still outweigh
the additional costs.
Amendment is
preferrable.
Heptac
hlor/
heptach
lor
oxide
Small
Updated EQS
based on new
science and re-
appraisal of risk,
would provide
more appropriate
protections.
The proposed EQS is less
stringent. No additional
costs expected.
The proposed
EQS is less
stringent,
meaning
resources can be
reallocated and
costs saved from
measures no
longer needed.
No specific
social
impacts
identified.
On the basis that new
scientific evidence has
been used to re-assess
the EQS and no/limited
impacts identified.
Amendment is
preferrable.
Hexach
loro-
benzen
Small
Updated EQS
based on new
science and re-
The proposed EQS is less
stringent. No additional
costs expected.
The proposed
EQS is less
stringent,
No specific
social
impacts
On the basis that new
scientific evidence has
been used to re-assess
201
Substa
nce
Distan
ce to
target
*
Environmenta
l impact
Economic Impact
Social
impact
Overall balance of
costs and benefits
Cost Benefits
e appraisal of risk,
would provide
more appropriate
protections.
meaning
resources can be
reallocated and
costs saved from
measures no
longer needed.
identified. the EQS and no/limited
impacts identified.
Amendment is
preferrable.
Tributy
ltin
Mediu
m
Updated EQS
based on new
science and re-
appraisal of risk,
would provide
more appropriate
protections.
Proposed EQS is more
stringent for biota. Given
use has ceased. Likely
measures include upgrade
of WWTWs and natural
attenuation. The costs of
the former will be
captured by the revised
UWWT Directive.
Avoided health
costs for
aquaculture and
ecosystem
services.
No specific
social
impacts
identified.
On the basis that new
scientific evidence has
been used to re-assess
the EQS and no/limited
impacts identified.
Amendment is
preferrable.
Dioxins
and
furans
Mediu
m
Updated EQS
based on new
science and re-
appraisal of risk,
would provide
more appropriate
protections.
Reduction in the proposed
EQS for biota could lead
to additional analytical
costs. Limited scope for
additional measures likely
natural attenuation.
No economic
benefits
identified from
amendment of
the EQS.
Some
additional
society
benefits in
tackling
environment
al
concentratio
ns given
bioaccumula
tion
potential.
On the basis that new
scientific evidence has
been used to re-assess
the EQS and no/limited
impacts identified.
Amendment is
preferrable.
Fluora
n-thene
Small
Updated EQS
based on new
science and re-
appraisal of risk,
would provide
more appropriate
protections.
The proposed EQS is less
stringent. No additional
costs expected.
The proposed
EQS is less
stringent,
meaning
resources can be
reallocated and
costs saved from
measures no
longer needed.
No specific
social
impacts
identified.
On the basis that new
scientific evidence has
been used to re-assess
the EQS and no/limited
impacts identified.
Amendment is
preferrable.
Hexach
loro-
butadie
ne
Small
Updated EQS
based on new
science and re-
appraisal of risk,
would provide
more appropriate
protections.
Proposed EQS is more
stringent, likely to trigger
some additional
exceedances, but grouping
will still be ‘small’.
Limited number of
sources, which would
target manufacturing and
end-of-pipe. Costs are
considered proportionate
to the addressed risks.
No specific cost
benefits
identified.
Improved
protections
for human
health.
Particularly
given
HBCDD is a
POP and
issues
around
bioaccumula
tion.
On the basis that new
scientific evidence has
been used to re-assess
the EQS and no/limited
impacts identified.
Amendment is
preferrable.
Nonyl
Phenol
Small
Updated EQS
based on new
science and re-
appraisal of risk,
would provide
more appropriate
protections.
Proposed EQS has a more
stringent AA and less
stringent MAC. Primary
issue is imported clothing.
Expect end-of-pipe
measures to address much
of the issue.
No specific cost
benefits
identified.
Improved
human
health
protections
from
additional
controls.
Improved
ecosystem
services.
On the basis that new
scientific evidence has
been used to re-assess
the EQS and no/limited
impacts identified.
Amendment is
preferable.
PAHs Mediu
Updated EQS
based on new
The proposed EQS could
be expected to trigger a
No specific cost
benefits
Improved
health
Based on the review
and reappraisal of
202
Substa
nce
Distan
ce to
target
*
Environmenta
l impact
Economic Impact
Social
impact
Overall balance of
costs and benefits
Cost Benefits
m science and re-
appraisal of risk,
would provide
more appropriate
protections.
new wave of exceedances,
including promotion of
the distance to target.
Measures will likely need
to target source-control on
combustion and
metallurgy and pathway
disruption for run-off
from road and field. Costs
could be significant.
identified. protection
from
avoiding
exposure to
PAHs.
Improved
ecosystem
services.
EQS additional
measures may be
warranted. Costs are
considered
proportionate to the
addressed risks.
Option assessed as
neutral
(High cost / high
benefit)
PBDEs Large
Updated EQS
based on new
science and re-
appraisal of risk,
would provide
more appropriate
protections.
The proposed EQS is less
stringent. No additional
costs expected.
The proposed
EQS is less
stringent,
meaning
resources can be
reallocated and
costs saved from
measures no
longer needed.
No specific
social
impacts
identified.
On the basis that new
scientific evidence has
been used to re-assess
the EQS and no/limited
impacts identified.
Amendment is
preferrable.
Mercur
y
Large
Updated EQS
based on new
science and re-
appraisal of risk,
would provide
more appropriate
protections.
Amendment of the EQS
will likely trigger the need
for additional source
controls and pathway
disruption. Costs are likely
to be significant.
Avoided costs of
health impacts
for aquaculture.
Avoided costs on
impacts to
ecosystem
services.
Greater
human
health
protections
on exposure
to mercury
as a chronic
pollutant.
The distance to target
was already large with
mercury responsible
for the highest number
of EQS failures.
The amendment of
biota EQS and
addition of AA EQS
will likely trigger a
new wave of
exceedances with
significant cost for
compliance. However,
the benefits are
equally as important.
Option assessed as
neutral
(High cost / high
benefit)
Nickel
Mediu
m
Updated EQS
based on new
science and re-
appraisal of risk,
would provide
more appropriate
protections.
Proposed EQS is
significantly more
stringent and likely to
trigger a wave of
exceedances. Primarily
measures will need to
target source-controls
(fossil fuel combustion,
metal manufacture, basic
organics, and surface
treatments), pathway
disruption (mine drainage),
and end of pipe treatments.
Avoided costs of
health impacts
for aquaculture.
Avoided costs on
impacts to
ecosystem
services.
Greater
human
health
protections
on exposure
to nickel as a
chronic
pollutant.
The proposed amended
EQS is likely to trigger
a new wave of
exceedances with
application of extensive
measures to achieve
compliance. This will
carry significant costs.
However, based on the
review of new evidence
the benefits from
avoiding impacts are
also more significant
than previously
thought.
Option assessed as
neutral
(High cost / high
benefit)
* Bold and red denotes a change in group based on amended EQS.
203
Table A9.5: Examples of monetized impacts for surface water Option 3
Environmental
impact
Economic Impact Social impact
Updated EQS based
on new science and
re-appraisal of risk
would provide more
appropriate
protections (all
substances).
Reduced
environmental
concentrations,
improved
environmental
protections for
ecosystem services
(cypermethrin,
nonylphenols,
PAHs).
Avoided health costs
for aquaculture
(cypermethrin,
tributyltin, mercury,
nickel)
Potential innovation
opportunity to
remove use as an
intermediate in
manufacture of
rubber products
(diuron).
Significant costs to ensure compliance for Cypermethrin, Chlorpyrifos,
Diuron, PAHs, Mercury, Nickel implementing a range of source control,
pathway disruption, targeted end of pipe treatment measures. Wastewater
treatment (end of pipe) related measures for heavy metal removal, generally
relates to primary treatments (usually primary settling followed by an
activated sludge process). Although, conventional treatment of wastewater
already significantly reduces the toxicity exposure from inorganic
constituents (including heavy metals) on freshwater and seawater, recent
available data on heavy metal speciation and removal shows that, during
primary settling, sorption technologies may cost effectively enhance the
removal of Cu and Ni, while coagulation may be efficient for Cd, Cr, Cu,
Pb, Zn and Hg removal (but not as efficient for Ni removal) 138 139
. Also,
scientific results show that Apatite can be suitable material to remove
cadmium, copper, nickel, cobalt and mercury from water140
.
For PAHs, e.g. the restriction proposal which would ensure that granules or
mulches (in particular from end-of-life tyres) are not placed on the market
for use or used as infill material in synthetic turf pitches or similar
applications if they contain more than 20 mg/kg in total of the eight
indicator-PAHs would cost €45m over a 10-year period. Run-off disruption
from roads would cost €75 million to install gully pots. Data suggests that
gully pots cost €50 per item to install and to be effective should be placed 50
metres apart. Based on the total length of all EU27 motorways (75,000 km),
around 1,500,000 gully pots should be installed. Also, water from the road
surface from motorways is typically channelled into surface water untreated.
Minor roads/city roads on the other hand are often connected to a Combined
Sewer Overflow (CSO) system and go to WWTWs. Therefore, minor roads
were excluded from the calculations.
Costs of additional controls and treatment for farmed animal use of
cypermethrin are €27.6 m. Wastewater treatment (Mercury, Nickel, PAH,
Cypermethrin) - €1.17- €26.2 per population equivalent, per annum
(technology dependent).
Mine drainage (Mercury / Nickel) - €100,000 -€10,000,000 per plant and
€0.4 per dm3
operating costs.
Moderate/Small costs to ensure compliance for Dioxins and furans,
Hexachlorobutadiene, Nonyl Phenol, Tributyltin due to small distance to
target and/or limited scope for additional measures (likely to be natural
attenuation and baseline end of pipe treatment (under the revised
UWWTD)). E.g. the costs of restricting nonylphenol (NP) and its
ethoxylates (NPE) in textiles was estimated to cost the EU €3.2m per annum
for a reduction of 15 tonnes of NP/NPE released to surface water.
No additional costs for Dicofol.
Monitoring: Amendments for Chlorpyrifos and Dioxins and furans could
lead to additional analytical costs (due to the proposed EQS being
considerably lower).
Cost savings and efficiencies: the proposed EQS is less stringent for
heptachlor/ heptachlor oxide, hexachlorobenzene, PBDEs and fluoranthene-
resources can be reallocated and costs saved from measures no longer
needed. For PBDEs it needs to be noted that the avoided costs for human
health will also decrease if a less stringent EQS would be implemented.
Improved protections for
human health particularly in
relation of POP substances,
issues around
bioaccumulation (dioxins
and furans, chlorpyrifos,
hexachlorobutadiene), EDC
(diuron, chlorpyrifos),
exposure to chronic
pollutants (mercury, nickel).
E.g. chlorpyrifos and PBDE
as endocrine disruptors
were associated with
attention deficit
hyperactivity disorder
(ADHD) and with other
cognitive deficiencies. The
productivity loss caused by
these disorders is estimated
to be €124 billion annually
in EU. Additionally,
prenatal exposure to
chlorpyrifos across the EU
would cost an additional
€21.4 billion in social costs.
The neurotoxicity of
chlorpyrifos is estimated to
be 70 to 100% according to
the epidemiological and
toxicological evidence,
which corresponds to a
social cost of €46.8 billion
and €195 billion annually in
the EU. It was also
estimated that the cognitive
deficits caused by
chlorpyrifos and
methylmercury would cost
the EU €177 billion and
€9.89 billion, respectively.
138
Heavy metal removal from wastewater using various adsorbents: a review: https://iwaponline.com/jwrd/article/7/4/387/28171/Heavy-metal-
removal-from-wastewater-using-various
139
https://www.researchgate.net/publication/350998245_Removal_of_Heavy_Metals_during_Primary_Treatment_of_Municipal_Wastewater_and_Possi
bilities_of_Enhanced_Removal_A_Review
140
Removal of cadmium, copper, nickel, cobalt and mercury from water by Apatite: https://pubmed.ncbi.nlm.nih.gov/21871722/
204
1.4. Option 4: Review possible deselection of substances shortlisted following
agreed deselection criteria.
The final option within the surface water category relates to the potential deselection of PS
that no longer present an EU-wide risk to the environment. A set of deselection criteria were
used to identify candidates for deselection. Deselected substances could and should still be
addressed as RBSPs at national level where a risk still exists.
The outcome of the impact assessment, which concluded that the identified substances could
be deselected from the PS list with the economic and environmental benefits outweighing any
potential costs. This includes consideration of the risk that use might recommence/increase.
Table A9.6: Surface water option 4 – summary of impacts
Substance Environmental impacts
Economic impacts
Social impacts
Overall
balance of
costs and
benefits
Cost Benefit
Alachlor
Banned in the EU for
many years, only 5 water
bodies out of 97,000
exceed the EQS. Risk to
environment is low.
Continued
monitoring
could be
expected
to utilise
finite
economic
resources
with more
limited
benefit.
Deselection
could free
up resources
that could be
reallocated
to
monitoring
and
controlling
emerging
risks.
Cost savings
€3.8 - €11.7
million Euro
per year
(monitoring
of 5
substances).
While the health hazards
of alachlor are clearly
documented, risk of
exposure is very low and
would not be expected
to increase.
Deselection
would have
more benefits
than costs.
Simazine
Banned in the EU for
many years, only 4 water
bodies out of 97,000
exceed the EQS. Risk to
environment is low.
While the health hazards
of simazine are clearly
documented, risk of
exposure is very low and
would not be expected
to increase.
Deselection
would have
more benefits
than costs.
Chlorfenvinphos
Banned in the EU for
many years, only 6 water
bodies out of 97,000
exceed the EQS. Risk to
environment is low.
While the health hazards
of chlorfenvinphos are
clearly documented, risk
of exposure is very low
and would not be
expected to increase.
Deselection
would have
more benefits
than costs.
Trichlorobenzenes
Still in use, and these
substances are acutely
toxic to the aquatic
environment. However, the
rate of exceedance is very
low. Possible to maintain
protection by designating
as a RBSP where needed.
Less monitoring would
reduce the information
available to assess
exposure and decide on
measures to reduce
emissions, but MS
should assess whether
these substances should
be designated and
managed as RBSPs.
Deselection
would have
more costs
than benefits.
Carbon
tetrachloride
Still in use but, is not a
POP, and as noted under
option 4, the rate of
exceedance is extremely
low and the risk to the
environment is equally
low. Possible to maintain
protection by designating
as a RBSP where needed.
Deselection
would have
more benefits
than costs.
2. Groundwater options
Tables A9.7 to A9.9 below summarise the impacts of implementing the groundwater policy
options, compared to the status quo. The options presented are mutually exclusive for each
substance group under consideration. More detailed economic costs of potential measures are
205
included in Annex 10. A note on the impacts of options not analysed in the main report is
included below.
Note on impacts of groundwater options not analysed in the main report
As shown in Annex 7 Table A7.3, three groundwater options were not discussed in the main
report in order to simplify the presentation and better reflect the key policy choices available.
These options were:
 a group of 10 PFAS included in Annex I and assigned a GW QS of 0.1 µg/l;
 group of 16 nrMs added to Annex I as individual substances with a GW QS of 1 µg/l;
 group of 16 nrMs added to Annex I as individual substances with a GW QS of 0.1
µg/l.
For transparency, and to report all analysis done, the impacts of these options are included in
the tables below and some explanatory text is also provided here.
PFAS
Costs for a group of 10 PFAS included in Annex I and assigned a GW QS of 0.1 µg/l will be
lowest, given the DWD requirements and additional data collated. This is especially the case
for the MS which are already monitoring PFAS and carrying out risk assessments for
groundwater.
Pathway disruption measures like the capture of contaminated sludge, containing and
incineration are very costly due the energy intensiveness, so these measures are suitable only
in extreme circumstances. Guidance on the best practise use of waste and wastewater by-
products in agriculture would be a cheaper option. However, this will ultimately result in
PFAS accumulating in agricultural soils. Instead of using pathway disruption measures, it is
more likely that for a group of 10 PFAS included in Annex I and assigned a GW QS of 0.1
µg/l actions to restrict use of PFAS and better management of waste streams are used, as well
as groundwater or soil remediation.
nrMs
The costs of adding nrMs to the monitoring networks are likely to be limited, since the
existing framework for assessing risk to groundwater from ‘parent’ pesticides and their
relevant metabolites are already in place. This is particularly the case for adding a group of
16 nrMs to Annex I with a GW QS of 1 µg/l and adding a group of 16 nrMs to Annex I with
a GW QS of 0.1 µg/l.
The implementation of the EU Farm to Fork Strategy will likely lead to reductions in the use
of any permitted parent pesticides of the nrMs considered. This will be delivered in part
through the planned revision of the Directive on the Sustainable Use of Pesticides and
national action plans for pesticide use reduction. This will limit what additional measures
need to be taken to protect their water bodies. By including all nrMs in Annex I under, the
administrative burden may be progressively reduced further as the legislation would be
“future proofed”.
Environmental benefits are rather similar for the 5 assessed options for nrMs but options
covering all nrMs and setting a GW QS at EU level are expected to generate greater benefits.
206
2.1. Option 1: Add LFR substances to GWD Annex I individually, and assign an individual
EU-wide GW QS
Table A9.7: Groundwater Option 1 – summary of impacts and preferred option
Description
Administrati
ve burden
Economic Impacts Environmental Impacts Societal Impacts Prefe
rred
optio
n?
Costs Benefits Costs Benefits Costs Benefits
PFAS (Group
of 10)
included in
Annex I and
assigned a
GWQS of 0.10
µg/l (based on
the drinking
water standard
for 20
identified
PFAS – the 10
PFAS would
be a subset of
the 20)
Costs - €15-
16 million
(Europe)
Benefits from
the DWD
implementati
on
Cost of
remediation of
legacy
pollution (to
taxpayer
where polluter
pays principle
cannot be
enforced).
From landfill
sites this could
amount to €0.7
million on
average, and
up to €77
million per
site.
Environmental
PFAS
remediation
totalling €821
million to
€170 billion
(EEA/EU),
with plausible
best estimate
of €10–20
billion.
Cost of high
temperature
incineration of
biosolids -
€5000-7500
million/yr (EU
level).
Cost of landfill
- €2000
million/yr (EU
level).
Restriction of
use: €390
million per
year per
substitute use.
Reduce
d energy
costs
and
related
process
costs for
wastewa
ter
treatme
nt to
tackle
PFAS.
Avoided
costs of
(pre)trea
tment as
a result
of
improve
d
quality
for
potable
water
and
process
water
for
drinking
water
supply,
agricult
ure
(irrigati
on,
livestoc
k
waterin
g taken
directly
from a
GWB)
and
industry
(GAC
treatme
Energy
intensive
measures
including
high
temperat
ure
incinerati
on of
biosolids
and other
PFAS
containin
g waste
materials.
Loss of
organic
materials
to spread
to land
by
farming
communi
ty.
Reduced energy
use for
wastewater
treatment to
tackle PFAS.
Increased
knowledge and
understanding of
the risks of PFAS
posed to the
water
environment.
Consistent
approach to data
collection at EU
level and
improved
knowledge (more
data collected)
on the impact of
PFAS.
Reduced
pollution of
groundwater.
Lower risk of
(irreversible)
damage to
natural resources
such as
groundwater and
connected
surface waters
and ecosystems
(i.e. reduced
impact on
sensitive water
bodies such as
wetlands and
rivers, and fish).
Loss
of
organi
c
materi
als to
spread
to land
by
farmin
g
comm
unity.
Avoided illness /
death through
lower exposure
to PFAS via
drinking water /
food. In the EEA
countries, health-
related costs
could reduce by
up to €52-84
billion per year
(based on
population of
207.8 million).
A healthy
ecosystem
(fishing,
swimming, etc.).
Sectors requiring
a high quality of
groundwater
such as bottled
water or
aquaculture.
Clean raw
groundwater for
abstraction (for
drinking water,
irrigation,
livestock
watering).
Avoided costs of
(pre)treatment as
a result of
improved quality
for potable water
and process
water for
agriculture and
industry.
Increased
knowledge and
understanding of
the risks of PFAS
posed to the
water
environment.
No –
prote
cts
again
st
curre
nt
know
n
PFAS
but
not
future
pollut
ion.
207
Description
Administrati
ve burden
Economic Impacts Environmental Impacts Societal Impacts Prefe
rred
optio
n?
Costs Benefits Costs Benefits Costs Benefits
PFAS (Group
of 24
proposed as
additions to
the surface
water
Priority
Substance
list) included
in Annex I and
assigned a GW
QS of 4.4 ng/l
PFOA-
equivalent. If
no RPF exists,
then the RPF
of PFOA
should be
assumed and a
GW QS of 4.4
ng/l applied.
€45-48
million
Highest
burden due to
need to use
RPFs
Benefits from
the DWD
implementati
on
nt costs
millions
of € per
site).
As above but
improved
targeting on more
potent PFAS.
Yes –
future
proof
ed /
huma
n
healt
h
focus
Carbamazepi
ne and
Sulfamethoxa
zole added to
Annex I and
assigned GW
QS of 0.5 and
0.1 µg/l
respectively.
Costs of
monitoring -
€2 million
(no
significant
additional
administrativ
e costs for
risk / status
assessments)
Generally
smaller than
under Option 2
due to the
focus on two
substances.
Product
substitution
viable for
Sulfathemoxaz
ole but
unlikely for
Carbamazepin
e - costs
associated
with
substitution of
pharmaceutica
ls and
availability of
alternatives.
Green
Pharmacy
initiatives in a
small number
of MS (<€1-10
million per
MS).
Treatment of
biosolids /
manures
unlikely to be
used
(disproportion
ately
expensive).
More
data
collecte
d to
understa
nd the
impact
of these
two
pharmac
euticals
Consiste
nt
approac
h to data
collectio
n at EU
level.
Reduce
d
pollutio
n of
ground
water
Impacts
from
substituti
on of
other
pharmace
uticals
with
increased
productio
n
As for
pharmaceuticals
under Option 2,
but with much
reduced scale as
only addressing
two pollutants.
Restric
ting
use
could
impact
on
health
and
well-
being
of
people
and
animal
s
where
alterna
tives
have
side
effects
/
differe
nt
efficac
y
Reduction in
AMR likely to be
small (mainly
covered by
baseline
measures)
Small increase in
well-being from
reduced risk of
chronic ingestion
in drinking water
/ improved
ecosystem health.
Positive impact
on shellfish and
fisheries where
groundwater
inputs to rivers
and estuaries is
significant
Yes
208
Description
Administrati
ve burden
Economic Impacts Environmental Impacts Societal Impacts Prefe
rred
optio
n?
Costs Benefits Costs Benefits Costs Benefits
nrMs (Group
of 16) added
to Annex I as
individual
substances
with a GW QS
of 1 µg/l.
€4-5 million
Costs of
monitoring
(no
significant
additional
administrativ
e costs for
risk / status
assessments)
Costs to
pesticide
sector through
loss of
approved
substances,
costs of
product
development
and product
substitution to
the farming
sector.
Substitute
pesticides are
available and
can be cheaper
(up to 3 times)
or up to 100
times more
costly than
permitted
parent
pesticides.
Cost of legacy
pollution from
landfill sites –
average of
€0.7 up to €77
million per
site.
Increased data
requirements
could make
gaining
authorisation
of new
products more
challenging.
Increase
d
availabil
ity of
clean
raw
ground
water
for
abstracti
on (for
drinking
water,
irrigatio
n,
livestoc
k
waterin
g).
Avoided
costs of
(pre)trea
tment as
a result
of
improve
d
quality
for
potable
water
and
process
water
for
agricult
ure and
industry
.
Better
data for
use
during
pesticid
e parent
authoris
ation
process.
Using
substitute
s that
have an
impact on
other
environm
ental
compart
ments.
Un-
intention
al
impacts
for
example
glyphosat
e is used
to destroy
cover
crops,
which are
used to
mitigate
nutrients
in run-off
/ leaching
from
agricultur
al fields
over
winter.
Reduced risk of
damage to
natural resources
such as
groundwater and
connected
ecosystems.
Increased
ecosystems
services from
groundwater
biota not
impacted by
nrMs and
cocktail effects.
Consistent
approach to data
collection at EU
level and
improved
knowledge (more
data collected)
on nrMs in
groundwater
leading to better
understanding of
risks.
Increased
knowledge and
understanding of
the risks of
metabolites of
pesticides posed
to the water
environment.
Improved
knowledge and
better data for
use during
pesticide parent
authorisation
process.
Climate change
benefits through
reduced energy
use (e.g. due to
changes to
wastewater and
drinking water
treatment
processes) (in the
case of source
control and
pathway
disruption
measures).
Potenti
al for
margin
al cost
increas
es in
food
produc
tion
due to
more
limited
choice
in
pestici
des.
A healthy
ecosystem
(fishing,
swimming, etc.)
Benefits to
sectors requiring
a high quality of
groundwater
such as bottled
water or
aquaculture.
Clean raw
groundwater for
abstraction (for
drinking water,
irrigation,
livestock
watering).
Avoided costs of
(pre)treatment as
a result of
improved quality
for potable water
and process
water for
agriculture and
industry.
Increased
knowledge and
understanding of
the risks of
metabolites of
pesticides posed
to the water
environment.
No
nrMs (Group
of 16) added
to Annex I as
individual
substances
As above but
more stringent.
As above
but more
stringent.
As above plus
reduced impacts
on groundwater
biota.
As
above
but
more
stringe
No
209
Description
Administrati
ve burden
Economic Impacts Environmental Impacts Societal Impacts Prefe
rred
optio
n?
Costs Benefits Costs Benefits Costs Benefits
with a GW QS
of 0.1 µg/l.
nt.
All nrMs
added to
Annex I as
individual
substances
with a GW QS
of 0.1 µg/l.
As above but
with future
proofing.
Yes
2.2. Option 2: Add LFR substances to GWD Annex I as groups, and assign an EU-wide GW
QS for the group “total” or “sum of”.
Table A9.8: Groundwater Option 2 – summary of impacts and preferred option
Descripti
on
Admin
istrativ
e
burden
Economic Impacts Environmental Impacts Societal Impacts Prefe
rred
optio
n?
Costs Benefits Costs Benefits Costs Benefits
All PFAS
added as
group to
Annex I
with a
GWQS
for
“PFAS
total” of
0.5 µg/l
(again
following
the
drinking
water
standard
for PFAS
total).
€45-48
million
Benefit
s from
the
DWD
implem
entatio
n.
Cost of
remediation of
legacy pollution
(to taxpayer
where polluter
pays principle
cannot be
enforced).
Cost of high
temperature
incineration of
biosolids €5000-
7500 million/yr
(EU level).
Cost of landfill
€2000 million/yr
(EU level).
Reduced
energy costs
and related
process
costs for
wastewater
treatment to
tackle
PFAS.
Avoided
cost of
drinking
water
treatment.
More data
collected to
understand
the impact
of these two
PFAS.
Consistent
approach to
data
collection at
EU level.
Reduced
pollution of
groundwate
r.
Energy
intensiv
e
measure
s
includin
g high
tempera
ture
incinera
tion of
biosolid
s and
other
PFAS
containi
ng
waste
material
s.
Loss of
organic
material
s to
spread
to land
by
farming
commu
nity.
Avoided costs of
availability of clean
raw groundwater
for abstraction.
Lower production
and maintenance
costs through
availability of
cleaner raw potable
groundwater.
Lower risk of
(irreversible)
damage to natural
resources such as
groundwater and
connected surface
waters and
ecosystems (i.e.
reduced impact on
sensitive water
bodies such as
wetlands and rivers,
and fish).
Benefit (avoided
costs) associated
with availability of
clean raw
groundwater for
abstraction (for
irrigation, livestock
watering taken
directly from a
GWB).
Loss of
organic
material
s to
spread
to land
by
farming
commu
nity.
A healthy
ecosystem
(fishing,
swimming, etc).
Sectors requiring a
high quality of
groundwater such
as bottled water or
aquaculture
Clean raw
groundwater for
abstraction (for
drinking water,
irrigation,
livestock
watering)
Avoided costs of
(pre)treatment as a
result of improved
quality for potable
water and process
water for
agriculture and
industry
Increased
knowledge and
understanding of
the risks of PFAS
posed to the water
environment.
No –
GW
QS
not
suffic
iently
preca
ution
ary /
prote
ctive,
altho
ugh it
future
proof
s
legisl
ation.
210
Descripti
on
Admin
istrativ
e
burden
Economic Impacts Environmental Impacts Societal Impacts Prefe
rred
optio
n?
Costs Benefits Costs Benefits Costs Benefits
All
pharmac
euticals
added as
a group to
Annex I
and
assigned a
GW QS
of 0.5
µg/l.
Costs
of
monitor
ing
plus
additio
n
adminis
trative
costs
€5.5
million
to €11
million.
Product
substitution / ban
use in animals
(viable for
Sulfathemoxazol
e but unlikely for
Carbamazepine -
€140,000
average cost of
alternative to
carbamazepine in
animals).
Returns program
/ Green
Pharmacy
initiatives –
focused on two
pharmaceuticals
(less than €1-€10
million per MS)
Capture of
biosolids – EU
level €2 to 7500
billion to landfill
or incinerate
Capture and
treatment of
animal manures
– EU level
Treatment of
wastewater
(baseline
measure – no
cost).
More data
collected for
pharmaceuti
cals in
groundwate
r leads to
better
understandi
ng of risks.
Consistent
approach to
data
collection at
EU level.
Future
proofed
legislation
leads to
reduction in
pharmaceuti
cals in
groundwate
r and
informs
industry /
permitting
of new
substances.
Energy
use to
capture,
store
and
destroy
biosolid
s and
animal
manures
to
prevent
leaching
to
ground
water.
Reduced pollution
of groundwater and
connected aquatic
ecosystems with
reduced impact on
sensitive habitats.
Reduced energy,
carbon emissions
and chemicals use
associated with
reduced treatment
of drinking water
(in the case of
source control and
pathway disruption
measures).
Increase reuse and
recovery of
pharmaceutical-free
materials (e.g. use
of sludge, treated
wastewater).
Increased
knowledge and
understanding of
environmental
behaviours of
pharmaceuticals.
Reduction in AMR
likely to be small
(mainly covered by
baseline measures)
- Reduction in
AMR through
control of anti-
biotic use (costs
avoided of €1.5
billion to the EU).
Restricti
ng use
could
impact
on the
health
and
well-
being of
animals
where
alternati
ves have
side
effects /
different
efficacy.
Capture
of
biosolid
s /
incinera
tion of
manures
has
impact
on
farming
sector
with
loss of
low cost
soil
improve
r /
fertiliser
.
Reduction in
AMR through
control of
Sulfamethoxazole
is small in
comparison to
baseline measure
of restricting
prophylactic use in
animals.
Increased
knowledge and
understanding of
environmental
behaviours of
pharmaceuticals
Small increase in
well-being from
reduced risk of
chronic ingestion
in drinking water /
improved
ecosystem health.
Benefits from
impact on shellfish
and fisheries
where
groundwater
inputs to rivers
and coastal
estuaries is
significant.
No
All nrMs
added to
Annex I
as a group
and
assigned a
group
GW QS
of 10
µg/l.
€4-5
million
Costs
of
monitor
ing (no
signific
ant
additio
nal
adminis
trative
costs
for risk
/ status
assess
ments).
Restrictions on
use of parent
pesticides across
specific sensitive
GWBs / drinking
water protected
areas (if not
statutory may
require
compensation for
lost crop yield).
Unlikely to
lead to loss
of parent
pesticides.
Using
substitut
es that
have an
impact
on other
environ
mental
compart
ments.
More data collected
for nrMs in
groundwater leads
to better
understanding of
risks.
Consistent approach
to data collection at
EU level.
Better data for use
during pesticide
parent authorisation
process.
Future proof for
other (unlisted)
nrMs.
Potentia
l for
cost
increase
s due to
lower
crop
yields.
As for nrMs under
Option 1 but in
restricted areas
only.
No
2.3. Option 3: Add LFR substances to GWD Annex II for MS to consider setting a TV for
specific substances posing a risk to groundwater bodies.
211
Table A9.9: Groundwater Option 3 – summary of impacts and preferred option
Option
Administra
tive burden
Economic Impacts Environmental Impacts Societal Impacts Preferr
ed
option?
Costs
Benefit
s
Costs Benefits Costs
Benefit
s
All PFAS
added as a
group to
Annex II for
MS to
consider for
the
development
of a TV for
specific
substances
posing a risk
to GWBs.
Less than
all other
options for
PFAS.
Benefits
from the
DWD
implementa
tion.
As for PFAS
under Option
1 but fewer
sites to
remediate.
As for
PFAS
under
Option
1, but
reduced
consiste
ncy /
less
data
collecti
on.
As for
PFAS
under
Option 1,
but
reduced
extent.
As for PFAS under
Option 1.
As for
PFAS
under
Option 1,
but
reduced
extent.
As for
PFAS
under
Option
1.
No - too
variable
and will
not
address
pollutio
n of
groundw
ater at
the EU-
wide
level.
All
pharmaceuti
cals added as
a group to
Annex II -
guideline to
include
carbamazepi
ne,
sulfamethoxa
zole and
primidone.
Costs
negligible
and
absorbed
into
baseline. If
all MS
added
Primidone
via Annex
II, the
additional
costs would
be half of
Option 1 for
pharmaceuti
cals.
Returns
program /
Green
Pharmacy
initiatives –
focused on
two
pharmaceutica
ls (less than
€1-10 million
per MS)
Treatment of
wastewater
(baseline
measure – no
cost).
Unkno
wn –
likely to
be
much
smaller
scale
than for
pharma
ceutical
s under
Options
1 and 2.
As for
pharmace
uticals
under
Option 2
but scale
depends
on how
far MS
impleme
nt
monitori
ng and
measures
.
Specific risks to
groundwater are
investigated and
dealt with locally
rather than through
EU wide schemes
which may be too
high level to be
effective.
Monitoring data
collected for at risk
pharmaceuticals with
a tailored approach.
As for
pharmaceu
ticals
under
Option 2
but scale
depends
on how far
MS
implement
monitorin
g and
measures.
As for
pharma
ceutical
s under
Option
2 but
scale
depends
on how
far MS
implem
ent
monitor
ing and
measure
s.
Yes,
only for
Primido
ne
All nrMs
added to
Annex II for
MS to
consider for
the
development
of a TV for
substances
that pose a
risk to their
GWBs.
Costs
negligible
and
absorbed
into
baseline.
Dependant
on risks
identified
from nrMs
by each
MS.
Inconsistent
approach
between MS.
Does not
influence
pesticide
approval
process.
More
data
collecte
d (but
less
than for
Annex I
listing).
Few
additiona
l costs
(uncertai
n) as the
extent of
these
impacts
will
depend
on the
TV
adopted
per MS.
The extent of these
impacts will depend
on the TV adopted.
Could improve
efficiency - specific
risks to groundwater
are investigated and
dealt with locally
rather than through
EU wide schemes
which may be too
high level to be
effective.
Few
additional
costs
(uncertain)
.
Limited
program
me of
measure
s
required
.
No
212
3. Monitoring, reporting and administrative streamlining policy options
Table A9.11 below depicts the additional impacts of implementing the monitoring, reporting
and administrative streamlining options, compared to the status quo. The options presented
are not mutually exclusive, and can co-exist. As illustrated in the main text, the proposed
policy options have significantly different economic, environmental and social impacts. An
overall assessment of the impacts is summarised below, whereby the options were
categorised as having (overall): no impact; positive impacts; negative impacts; or neutral
impacts.
Sub-options under Policy Option 1 include the drafting of (additional) guidance documents.
For the economic impacts of these sub-options, the primary cost will be the development of
the guidance document itself. To estimate the costs of developing a guidance document, it is
important to note that these are largely dependent on the scope of the guidance, its breadth
and the process followed. Extensive guidance documents that involve a lot of technical input
(e.g. Best Available Technique Reference Documents under the Industrial Emissions
Directive) are an example of costly guidance documents that take years to develop. Within a
process like the WFD Common Implementation Strategy guidance, such documents are not
envisaged. The primary difference between the two cost estimates stems from the effort
required in establishing the guidance document. One-off estimates of costs for the
development of several types of guidance documents are presented in Table A9.10 below.
Under the WFD CIS, only simple to more elaborate technical guidance documents are
drafted, thus not exceeding €500,000 per document.
Table A9.10: Categories for estimating cost of guidance documents
Type of guidance Range of cost per guidance (€)
Simple Up to €290,000
Elaborate €290,000 – €500,000
Extensive €5 million – €10 million
213
Table A9.11: Monitoring, reporting and administrative streamlining policy options – summary of impacts
Option description
Impacts
Overall balance of
costs and benefits
Environmental
impact
Economic
impact
Social impact
Option 1 – Provide / improve guidance and advice on monitoring
Option 1a: Develop
guidelines on applying
innovative methods in
monitoring procedures,
including
continuous/automated
monitoring techniques.
Neutral impact: depending
on the measures that will be
described in the document.
Limited cost
(≤€500,000) to develop
the guidance document.
Other costs to MS
depend on uptake of
measures.
Likely to have
positive social
impacts depending
on uptake of
measures.
Depending on
uptake of measures.
Option 1b: Follow -up to
improve existing guidelines
on EBMS in view of setting
application ‘trigger values’
in practice to improve
monitoring of
groups/mixtures of
pollutants by using EBMs,
and trigger values.
Guideline impacts would be
neutral, and dependent on
uptake of measures.
Limited cost
(≤€500,000) to develop
the guidance document.
Likely to have
positive social
impacts depending
on uptake of
measures.
Option 1c: Develop a
harmonised measurement
and monitoring
methodology and guidance
for microplastics, as a basis
for mandatory MS reporting
on microplastics and a
future listing under
EQSD/GWD.
Positive impact in the longer
run, allowing for monitoring
and ultimately regulating
microplastics levels in
water.
Limited cost
(≤€500,000) to develop
the guidance document.
In the longer run,
positive health
impacts from
preventing exposure
to microplastics, as
well as reduction of
costs of water
treatment
downstream.
Benefits clearly
outweigh costs
Option 1d: Develop
guidelines on sampling
frequency for PS and
RBSPs.
Neutral impact: depending
on the measures that will be
described in the document.
Limited cost
(≤€500,000) to develop
the guidance document.
Other costs to MS
depend on uptake of
measures.
Likely to have
positive social
impacts depending
on uptake of
measures.
Depending on
uptake of measures.
Option 1e: Provide a
repository for sharing best-
practices from MS regarding
available monitoring
techniques, and foster
cooperation to implement
these.
Possible positive impacts,
but depending on uptake of
knowledge and
implemented actions.
Minimal economic
costs, with significant
benefits to knowledge
sharing and innovation.
Likely to have
positive social
impacts through
more accurate
monitoring.
Benefits outweigh
initial costs due to
knowledge sharing
and development.
Option 2 – Establish / amend obligatory monitoring practices
Option 2a: Include an
obligation in the EQSD to
use EBMs to monitor
estrogens.
Provision on monitoring
estrogens will have positive
impacts.
Costs due to
monitoring of estrogen
are low, but possible
measures to be taken
due to monitoring
results may be
substantial.
Monitoring of
estrogen will have
positive impacts by
allowing better
targeting of policy
measures.
Costs of monitoring
estrogens are
outweighed by
significant benefits.
Option 2b: Establish an
obligatory groundwater
watch list mechanism
analogous to that of surface
waters and drinking water,
and provide guidance as
necessary on the monitoring
of the listed substances.
Positive impacts due to
better decision-making
processes regarding
substances posing risks and
better comparability of data.
Additional cost for
monitoring and
reporting, balanced by
benefits of more
comparable and
coherent data to
implement efficient
measures to improve
groundwater status.
Neutral impacts
Benefits through
enhanced data
comparability and
cohesion out-weigh
costs of monitoring.
214
Option description
Impacts
Overall balance of
costs and benefits
Environmental
impact
Economic
impact
Social impact
Option 2c: Improve the
monitoring and review cycle
of the surface water watch
list so that there is more
time to process the data
before revising the list.
Neutral impacts as they
depend on the actions
implemented (i.e. which
substances added to Priority
Substance list), but expected
to be positive
Neutral impacts due to
administrative costs for
additional and more
frequent monitoring,
compensated by
decrease in frequency
of updating the list
Neutral impacts
Significant
environmental
benefits and reduced
reporting burden
likely to outweigh
the possible costs of
monitoring
frequency- yet this
is dependent on the
measures
implemented
following enhanced
monitoring
procedures.
Option 3 – Harmonise reporting and classification
Option 3a: Establish an
automated data delivery
mechanism for the EQSD
and the WFD to ensure easy
access at short intervals to
monitoring/status data to
streamline and reduce
efforts associated with
current reporting, and to
allow access to raw
monitoring data.
Positive impacts by
improving accessibility of
spatial/temporal knowledge
for more effective actions.
Initial cost for aligning
data and establishing
harvesting
mechanisms, but
outweighed by benefits
of data-sharing and
long-term cost savings
for reduced reporting.
Positive impacts due
to accessibility of
information.
Significant long-
term benefits
outweighing initial
costs.
Option 3b: Introduce a
reference list (repository of
standards) of EQS for
RBSPs as an annex to the
EQSD and modify Annex V
of WFD section 1.2.6
(Procedure for the setting of
chemical quality standards
by MS) accordingly, and
incorporate RBSPs into the
assessment of chemical
status for surface waters.
Positive impact through
harmonization of EU-wide
standards allowing more
effective measures
Negative impact due to
agreeing on RBSPs
EQSs likely leading to
substantial costs for
MS for implementation
of monitoring and costs
for economic actors
taking measures where
necessary
Positive impacts for
social well-being and
health, providing
equal standard of
water resource across
EU
Significant
environmental and
social benefits
outweigh the
possible costs
incurred by MS and
economic actors.
Option 4 – Legislative and administrative aspects
Option 4a: Use an annex in
the EQSD instead of Annex
X to the WFD to define the
list of PS, and update the
lists of SW and GW
substances by Comitology
or delegated acts.
Positive impact due to
quicker actions to address
new substances.
Neutral impact due to
cost of measures to be
taken by economic
actors and minor costs
associated to delegated
acts, but balanced by
stimulating innovation
and possible
improvement in market
competitiveness.
Positive impacts as
innovation and
research will lead to
possible employment
opportunities.
Significant
environmental,
economic, and
social benefits that
out-weigh possible
costs.
Option 4b: Change the
status of the ‘eight other
pollutants’ added to the
EQSD from the former
Dangerous Substances
Directive (76/464/EEC) to
that of PS/PHS.
Pesticides: Aldrin, Dieldrin,
Endrin, Isodrin, DDT (all to
The cyclodiene pesticides
Aldrin, Dieldrin are
suspected to be
Carcinogenic and
recognised as POP. Endrin
is recognised as POP and
toxic for the nervous
system. Isodrin is very toxic
to aquatic life with long
lasting effects. For DDT, the
Minor additional
compliance costs
(extremely low current
exceedances).
The societal benefits
of monitoring
tetrachloroethylene
and trichloroethylene
within the water
environment may be
a valuable addition
to help track
emissions and
possible human
Benefits outweigh
the costs.
215
Option description
Impacts
Overall balance of
costs and benefits
Environmental
impact
Economic
impact
Social impact
PHS)
Industrial chemicals:
Tetrachloroethylene,
Trichloroethylene (to PHS)
Note: Carbon tetrachloride
is deselected under surface
water option 4, hence is not
considered here.
isomer 111 -trichloro -22 bis
(p - chlorophenyl) ethane is
recognised as POP and is
suspected to be
carcinogenic. DDTs are also
known endocrine disruptors.
Tetrachloroethylene and
Trichloroethylene are
mutagenic and carcinogenic.
The rate of EQS exceedance
suggests environmental risk
is low.
Greater coherence in the
policy landscape would
have societal benefits for
how these substances are
addressed.
exposure via the
environment.
Option 4c: Change the
status of some existing PS to
that of PHS where it fulfils
the criteria of the POP
Regulation and/or Article 57
of REACH Regulation.
Industrial chemicals: 1,2-
Dichloroethane,
Fluoranthene, Octylphenol,
Pentachlorophenol
Metals: Lead
Greater coherence in the
policy landscape would
have environmental benefits
for how these substances are
addressed.
No costs –
administrative change
only.
Greater coherence in
the policy landscape
would have societal
benefits for how
these substances are
addressed.
Benefits outweigh
the costs
216
ANNEX 10: POTENTIAL COSTS OF SELECTED SURFACE WATER AND GROUNDWATER
POLLUTION REDUCTION MEASURES
Surface water measures
Within the pharmaceuticals category, possible measures MS could take is trying to
reduce the demand and or the production of the most harmful substances by encouraging
producers to switch to manufacturing alternatives. This could lead to an increase in
demand for alternatives that fill a similar function to the original substance. For the
pharmaceuticals, an illustrative list of potential alternatives is presented in the table
below with a range of costs. Where the information was available, data on the average
costs of a prescription for each pharmaceutical has been supplied. Note, it is not possible
to extract information on the size of each prescription. Furthermore, there will be
differences in the typical effectiveness of each substance. As a result, the total cost of
treating a given condition using either the original pharmaceutical or the alternative will
vary from the values given in Table A10.1.
Table A10.1: Pharmaceutical substances, potential alternatives, and the costs of each
Original substance
Cost per prescription of
substance (EUR)*
Alternative substance
Cost range for the
prescription of
alternatives
(EUR)*
17-Beta estradiol (E2) 9.87
Tibolone, Clonidine,
Sertraline
10.42 to 23.29
Azithromycin 13.75
Clarithromycin,
Erythromycin
3.99 to 33.02
Clarithromycin 3.99 Azithromycin 13.75
Erythromycin 33.02
Clarithromycin,
Azithromycin
3.99 to 13.75
Carbamazepine 7.45
Pregabalin, Gabapentin,
Phenytoin
4.36 to 23.40
Diclofenac 11.93
Aspirin, Celecoxib,
Indometacin, Naproxen,
Etoricoxib, Ibuprofen
4.00 to 8.93
Ibuprofen 8.93
Aspirin, Celecoxib,
Etoricoxib, Diclofenac
4.00 to 11.93
* Only possible substitute substances within a price range of max 3.5x the costs of the original substance are included in the table.
Costs are 2021 values and converted from GBP using an average of 1 GBP = 1.15 EUR over period from 2 January 2020 to 31
December 2021.
For pesticides and biocides, the best approach for limiting emissions to environment (and
therefore environmental concentrations) is to restrict use in specific settings or ban use
entirely (assuming priority hazardous substance status). This requires looking into
possible alternatives that might be available instead. The table below provides an
overview of possible alternatives to the candidate priority/priority hazardous substances”
(non-exhaustive analysis of alternatives to pesticides). Where many alternatives exist, it
is possible to identify alternatives with similar efficacy and cost. Therefore, a restriction /
ban could be used as a viable measure with the price differential affecting farmers, vets,
society, and manufacturers of pesticides/biocides. An online marketplace was used to
establish estimates for the wholesale cost of the relevant pesticides and their alternatives,
and the application rates of these substances, it was possible to derive estimates for the
217
costs per hectare of application associated with each in Table A10.2 below. It should be
noted that the costs were obtained from estimations based on sales prices of bulk
chemicals. The values provided should therefore be viewed with this in mind.
Table A10.2: Pesticides, their possible alternatives, and the estimated costs
Pesticide substance
(type in brackets:
H:Herbicide;
F:Fungicide:
I:Insecticide)
Candidate priority
substance
Cost (EUR) per
hectare*
Possible alternative
Cost range for
possible alternative
substances
Cost (EUR) per
hectare*
Acetamiprid (I) 3.43
Fludioxonil, Spirotetramat,
Tebufenozide, Flonicamid, Avermectin
0.03 to 4.58
Clothianidin (I) 0.82 Pyriproxyfen 0.55
Thiacloprid (I) 0.61 See alternatives to acetamiprid
Thiamethoxam (I) 0.92 No likely alternatives identified yet
Bifenthrin (I) 0.24 Cypermethrin 0.07
Esfenvalerate (I) Lambda-cyhalothrin 0.03
Deltamethrin (I) 0.06 Lambda-cyhalothrin, Pirimicarb 0.03 to 0.33
Nicosulfuron (H) 0.27 Mesotrione, Tembotrione, Glyphosate 0.62 to 1.53
Glyphosate (H) 1.53
Penoxsulam, Florasulam, Oxyfluorfen,
Propaquizafop, Clethodim, Metribuzin,
Dicamba, Diflufenican, Bentazone,
Propyzamide, Bifenox, Chlorotoluron
0.02 to 4.12
* Only possible substitute substances within a price range of max 3.5x the costs of the original substance are included in the table.
Costs are converted using an average of USD 1 = EUR 0.8619 for the period between 6 April 2021 to 6 April 2022.
For pesticides in particular a major pathway to environment is run-off from fields, with
spray-drift as secondary pathway. This assumes that good farming practices should
already limit the risks associated with spray drift from use of pesticides in boom-
sprayers, back-pack sprayers, and crop dusting. Participants in the stakeholder workshops
indicated that the use of physical barriers is not at saturation level and more can be done.
Consequently, calculations have been undertaken to derive indicative (orders of
magnitude) costs attributed to the application of pathway disruption141
for pesticides
using physical barriers (see Table A10.3 below). The footnote to the table provides
further details on how these calculations have been made, but it should be noted that
there is a high level of uncertainty in the estimates, and the values in table should only be
used for comparative purposes and orders of magnitude only. In line with the polluter
pays principle, it is assumed that these costs would be borne by farmers either through
implementation of barriers on the land (e.g., buffer strips), or through additional activities
relating to biocides (capture and management of wastes contaminated with biocides).
From these estimations, it appears that the use of physical barriers for the treatment of
glyphosate would come at the highest cost, but this reflects its very high usage rates
across the EU. A possible compromise position could be a combination of source control
(reduce use through greater application of alternatives) and reduced need for pathway
disruption options.
141
The values in the table can only be used for comparative purposes and orders of magnitude. In line with the polluter pays principle,
it is assumed that these costs would be borne by farmers either through the setting up of barriers on the land (e.g., buffer strips), or
through additional activities relating to biocides (capture and management of wastes contaminated with biocides).
218
Table A10.3: Pesticides for which the use of physical barriers could possibly be further increased, and
associated costs of such measures
Substance Measure
Total cost*
(€), million
Acetamiprid Physical barriers to surface water buffer strips (see notes to right) 1.6
Clothianidin
Potential to create physical barriers to surface water seems particularly
high in the intensive rearing of poultry sector due to use as biocide.
Additional emission controls for farm waste.
162
Imidacloprid
Potential to create physical barriers to surface water seems particularly
high in the intensive rearing of poultry sector due to use as biocide.
Additional emission controls for farm waste.
162
Nicosulfuron Physical barriers - buffer strips 12.8
Deltamethrin
Physical barriers - additional controls and treatment for farmed animal
use
184.6
Esfenvalerate Physical barriers to surface water buffer strips No data
Glyphosate Physical barriers to surface water buffer strips 284.7
*Cost calculations for buffer strips: data has been gathered on tonnes of pesticide used per annum as well as application rates per
hectare. Based on previous section for pharmaceuticals again assume that the vast majority of arable land is away from rivers and
water courses with limited risk of run-off. On that basis assume that 10% of arable land is at risk as a worst-case scenario, and then
apply buffer strips at €160 per hectare.
Cost calculations for biocidal use in farms (chicken coops and stables): data has been gathered from Eurostat for numbers of
animals, and excretion rates 1,000 chickens produce 65 tonnes of litter per annum. Assume all litter and wastes will need to be
retained and incinerated. All washings retained and sent for further treatment (e.g., ozonation/GAC/PAC etc.) and not washed
directly to drain, costs per dm3
applied.
For pesticides used in agricultural settings the pathway via end of pipe is less relevant,
although use of pesticides in amenity areas with hard surfaces that allow wash-off/run-off
to storm drains will be important. Conversely, the use of biocides, can be carried out both
in outdoor settings (e.g., sheep-dips), and indoor settings (stables, coops, domestic
homes, work-places, etc.). Therefore, for biocidal uses, particularly within indoor
settings, the potential was wash-off or rinsing to drains during cleaning and maintenance
is an issue. Based on work already completed by the JRC to support the revision of the
urban wastewater directive and further implementation of quaternary treatment
technologies, an analysis of technologies, unit prices, and efficacies for the possible
removal of specific substances was made. The same methodology as outlined in the
previous sub-section for pharmaceuticals has been used to help identify options and costs
for end-of-pipe measures for those substances with biocidal uses. Table A10.4 below
provides these results.
Table A10.4: Estimated costs of end-of-pipe measures for biocides
Substance Measure
Cost (€ per population
equivalent/ per yr)
Efficacy (%)
Clothianidin, Imidacloprid,
Deltamethrin
WWTWs - Ozonation 10 From 90 – to 99
Triclosan
WWTWs - Reverse
Osmosis
20.7 90-100
Acetamiprid, Thiamethoxam,
Permethrin
WWTWs - GAC 26.2 to 32 From 83 to 99
* Costs for EU27 in € / year - costs are amortised (assuming 25 year asset lifetime)
219
Groundwater measures
Table A10.6: Costs of selected measures to address groundwater pollution by PFAS
Measure
Type of
measure
Unit Unit cost Comment on calculation
Soil remediation
Receptor
remediation
EU level
€5 to €760 million
at EU level (one
off cost)
Remediation of point sources based on an
assumed total of 10-20 airfields / fire
training stations sites at EU level identified
for remediation.
Soil remediation costs per site are given for
low (2,700 m3
) and high (28,125 m3
)
volumes of contaminated soils:
 Soil incineration - €0.5-18 million per
site
 Landfill – €2.5-38 million per site
Groundwater pump and treat costs per site
is €2.9-30.3 million over a 30-year period
of construction, operation and maintenance
(120). Annual equivalent costs are €0.17
million-€1.75 million per site respectively.
Groundwater
remediation
Receptor
remediation
EU level
€1.7-€35 million /
yr at EU level
(annualised over
30 years)
Capture of
biosolids for
treatment
End of pipe
control -
WWT
EU level
€201 million per
year to send to
landfill
€503-755
million/yr for high
temperature
incineration
High temperature sludge incineration: Total
sludge generated in EU:
441 million (population) x 0.0782 kg per
person/day (dry weight) = 34,398 tonne/day
or 12.6 million tonnes /yr.
Assume 10% requires incineration – 1.26
million tonnes /yr at a cost of €400-
600/tonne = €500-755 million/yr.
Cost to send to landfill of the 1.26 million
tonnes/yr (2013 highest landfill gate fee and
tax of €160 per tonne (121)) - €201 million
per year.
Capture of
industrial waste,
e.g. in paper mills
Source control
- WWT
EU level
Landfill - €76.72
million / yr
High temperature
incineration -
€191.8 to €287.7
million / yr.
The 894 paper mills in the EU recycled
47,950,000 tonnes of paper in 2020 (122).
10% ends up as recycling paper sludge
waste with potential for spreading to land
i.e. 4,795,000 tonnes/yr available. Assume
that a further 10% of this sludge waste is
contaminated with PFAS i.e. 479,500
tonnes per year requires treatment.
Cost to send the same volume to landfill
(using the highest gate fees in 2013 of
€160/t) is €76.72 million/yr.
High temperature incineration (as for
biosolids) - €191.8 to €287.7 million/yr.
Not costed – the loss to the farming sector
of cheap soil improver.
Landfill leachate
treatment
Source control Per site
Between €530 and
€358 million
Capex and Opex for two pass reverse
osmosis system with pre-treatment and
evaporation ponds dealing with 17.5 m3
/yr
leachate (123).
Guidance on
proper use of
PFAS containing
products which
could be spread to
land
Source control
(Behavioural)
One set of
European
level
guidance
or per MS
€50,000
Take back
schemes/
incentives to
replace domestic
products that may
contain PFAS
Source control
(Behavioural)
per MS Millions
See see Section 6.2.1 and table A9.7 for
derivation
220
Measure
Type of
measure
Unit Unit cost Comment on calculation
Restriction of use
of PFAS in one
sector (fire-
fighting foams)
Source control EU level
€390 million / yr
over 30 years (per
use)
Cost of restriction on PFAS in fire-fighting
foams, based on estimated cost on placing
on the market and after use / sector specific
transitional periods (see Section 6.2.1 and
table A9.7 for derivation).
Cost is for use of PFAS. Other key sectors
are personal care products, food packaging,
chrome metal plating, building materials,
electronics – assuming replacement in 10
further uses - €3,900 million/yr over 30
years.
Table A10.7: Costs of selected measures to address groundwater pollution by pharmaceuticals
Measure
Type of
measure
Sulfamethoxazole
Carbamazpine
Primidone
Unit Unit cost Comments
Ban use in
agricultural
animals
Source control
(animals)
Y N Y 0 0
Sulfamethoxazole - Assume
no cost difference for many
alternatives available but risk
of swapping pollutant is
possible.
Product substitution deemed
not feasible for
carbamazepine in animals
(costs of €140,000).
Provide guidance
on proper disposal
Source control
(prescribing)
Y Y Y
One set of
European
level
guidance
or per MS
€50,000 circa
Improved returns
program for
unused drugs
Source control
(prescribing)
Y Y Y MS level
Less than €1-
10 million
Represents better investment /
expansion of a returns scheme
to more substances (based on
France Cyclamide scheme -
population circa 60 million).
Establish national
returns programs
(if non-existent)
Source control
(prescribing)
Y Y Y MS level €1-10 million
Costs based on France
Cyclamide scheme – (actual
costs will depend on
population of MS - FR
population circa 60 million).
Innovation in
green pharmacy –
allow medicine
experts to
promote prudent
use and correct
disposal of
pharma -
Source control
(prescribing)
Y Y Y MS level €1-10 million
Tailoring drug
dosage/ providing
a range of
package sizes
Source control
(prescribing)
Y Y Y MS level 0
Likely to be cost neutral /
administrative costs / start up
but will use less of the active
ingredient.
Improved sludge
management at
wastewater
treatment works
End-of-pipe /
pathway
disruption
Y Y Y EU level
€201 million
per year to
send to
landfill
€503-755
million//yr for
high
High temperature sludge
incineration. Total sludge
generated in EU:
441 million (population) x
0.0782 kg per person/day (dry
weight) = 34,398 tonnes/day
or 12.6 million tonnes/yr.
221
Measure
Type of
measure
Sulfamethoxazole
Carbamazpine
Primidone
Unit Unit cost Comments
temperature
incineration
Assume 10% is highly
contaminated and requires
incineration - 1.26 million
tonnes/ year at a cost of €400-
600/tonne= €503-755
million/yr.
Cost to send to landfill of the
12.6 million tonnes /yr (2013
highest landfill gate fee and
tax of €160 per tonne (121)) -
€201 million per year.
Note EU requirement to
reduce landfill to 10% by
2035 and the high energy
costs of incineration so this
measure is not coherent.
Table A10.8: Costs of selected measures to address groundwater pollution by nrMs
Measure
Type of
measure
Unit Unit cost Comment
Ban / restrict
agricultural
uses of parent
pesticide (use
substitute)
Source control
Cost
difference of
use of
substitute per
hectare
Flufenacet can be 3 times
cheaper
Fluopicolide – 30 to 100
times more costly
Glyphosate similar or up to
40 times more expensive
Metazachlor – one eight to
half the cost
Costs of permitted parent
substitute pesticides –
dimethachlor substitute is
metazachlor so not
appropriate
Historical
landfill
remediation to
deal with
pesticide
contamination
End of pipe /
pathway
disruption
EU level
No EU estimate /
extrapolations available only,
limited indicative data from 1
Member State
Irish EPA expenditure on
landfill remediation in 2019
at 122 sites €158.4 million
ranging from €690,000 to
€77 million to per site.
222
ANNEX 11: SURFACE WATER MONITORING DATA
Table A11.1: Monitoring data for candidate PS
Substance Main uses / sources of pollution
Indication of
current
concentrations in
surface water
mean (min and
max) µg/L
MS providing
surface water
concentration data
Pharmaceuticals
Estrogenic
hormones
Estrone (E1)
Used as medication, e.g. in hormonal birth
control, menopausal hormone therapy,
treatment of hormone-sensitive cancers.
1.59 (0.0003-
24.49)
CZ, ES
17-eta-estradiol (E2)
0.00095 (0.0003-
0.0033)
CZ, RO
Ethylestradiol (EE2)
0.000882
(0.00005-0.005)
CZ, RO
Macrolide
antibiotics
Azithromycin
Used in animal farming and as medication
to treat various infections
41.5 (0.01-
3,145.38)
CZ, ES
Clarithromycin 15.4 (0.01-391) CZ, ES, DE
Erythromycin 17.2 (0.01-200) CZ, ES, DE
Other
Carbamazepine
Used as medication to treat trigeminal
neuralgia, diabetic neuropathy and bipolar
disorder.
0.053 (0.005-1.85) CZ, DE, ES, LU, NL
Diclofenac
Used as medication to treat mild to
moderate pain, or signs and symptoms of
osteoarthritis or rheumatoid arthritis.
15.1 (0.005-3,998) CZ, DE, ES, LU, RO
Ibuprofen
Used as medication to reduce fever and
treat pain or inflammation caused by many
conditions.
0.0740 (0.005-10) CZ, DE
Pesticides
Neonicotinoids
Acetamiprid
Used to control insect pests in agriculture
(crops, vegetables, fruits), animal farming
(e.g. for invertebrate pest control in fish
farming).
0.0055 (0.000195
– 0.0644)
Data anonymised
Clothianidin 1.45 (0.005-25) CZ, ES, SE
Imidacloprid
2.83 (0.00005-
400)
CZ, DE, ES, IT, NL,
SE
Thiacloprid 1.02 (0.0005-88) CZ, ES, FI, IT, SE
Thiamethoxam
0.0437 (0.0005 –
2.7135)
Data anonymised
Pyrethroids
Bifenthrin
Used to control insect pests in agriculture,
public health and animal farming.
0.1125 (0.0338 –
0.436)
Data anonymised
Deltamethrin
0.0535 (0.001 –
0.19)
Data anonymised
Esfenvalerate
0.0430 (0.004 -
0.1495)
Data anonymised
Permethrin 0.162 (0.0005-20) CZ, FI, FR, IT, SE
Other
Glyphosate
Used as an herbicide to control weeds and
grasses. Current approval expires December
2022, but likely to be extended.
0.525 (0.001-790)
CZ, DE, ES, FI, FR,
IE, IT, NL, SE, SK
Nicosulfuron Used as an herbicide to control weeds.
0.0160 (0.00206-
3)
DE
Triclosan
Used as an antibacterial and antifungal
agent in some consumer products, including
toothpaste, soaps, detergents, toys, and
surgical cleaning treatments. Also added to
other materials, such as textiles, to make
them resistant to bacteria.
0.0142 (0.0001-
0.458)
CZ, DE
223
Substance Main uses / sources of pollution
Indication of
current
concentrations in
surface water
mean (min and
max) µg/L
MS providing
surface water
concentration data
Industrial
chemicals
Bisphenol A
Used in the manufacture of various plastics,
including for shatterproof windows,
eyewear, water bottles, and epoxy resins
that coat some metal food cans, bottle tops,
and water supply pipes.
0.623 (0.0005-
1,300)
CZ, DE, ES, FI, IT,
LT, SK
PFOA and PFOS
and its derivatives
(PFAS)
Used in stain- and water-resistant fabrics
and carpeting, cleaning products, paints,
and fire-fighting foams.
0.288 (0.00003-
120)
CZ, DE, ES, FR, IT
Metals
Silver
Nanosilver and other forms of (ionic) silver
are widely used nowadays for their
antibacterial activity, e.g. in silver
containing personal care products (PCP),
medical products and a wide range of other
consumer products. It is noted that
currently, products that contain forms of
(nano)silver are difficult to track since they
are marketed under numerous brand names,
and, with a few exceptions, current
labelling regulations do not specifically
require listing nanomaterials as a
constituent.
In some areas silver is also a naturally
occurring substance e.g. around metal
mines.
0.524 (0.003-25)
CZ, DE, FR, IE, IT,
LU, NL, PL, RO
224
Table A11.2: Monitoring data for existing PS
Substance
Main uses / sources of
pollution
Curre
nt
EQS
for
inlan
d
surfa
ce
water
s
µg/L
No. of
WBs
with
EQS
excee
dance
No. of
MS with
at least 1
WB in
exceedan
ce142
(pass
/fail)
MS
reportin
g
exceeda
nces (as
pass/fail
status)
Indication of
current
concentrations
in surface
water
mean (min and
max) µg/L
MS providing
concentration
data
Substances considered for EQS amendment
Pesticides
Chlorpyr
ifos
Past use as an insecticide to
control foliage and soil-borne
insect pests on a variety of
food and feed crops. Not
approved since 2019. No
ongoing commercial use.
AA:
0.03
MAC:
0.1
523 9
BE, CY,
CZ, DE,
ES, FR,
IT, NL,
SK
0.187 (0-500)
AT, BE, BG,
CY, CZ, DE,
ES, FI, FR, HR,
IE, IT, LT, LU,
MT, NL, PL,
PT, RO, SK
Cyperme
thrin
Used in the protection of
wood against wood-destroying
insects, applied as an
insecticide in agriculture and
topically in veterinary
applications. Ongoing
commercial use.
AA: 8
10-5
MAC:
6 10-4
9 1 CZ
(<LOQ (0.01) –
0.0864)
ES, CZ, DE,
FR
Dicofol
Not approved since 2008. No
ongoing commercial use.
AA:
1.3
10-3
MAC:
n/a
0 0 -
All below LOQ
(0.0004)
CY, CZ, DE,
ES, FR, IT
Diuron
Past use as a pre-emergence
herbicide for general weed
control on non-croplands, in
and around water bodies and
as a component of marine
anti-fouling paints. Not
approved for pesticide use
since 2020. Still used within
industrial chemicals.
AA:
0.2
MAC:
1.8
1,509 11
BE, CZ,
DE, EL,
ES, FR,
HU,IT,
NL, NO,
SK
0.390 (0-2,295)
AT, BE, CY,
CZ, DE, DL,
ES, FI, FR, HR,
IE, IT, LT, LU,
MT, NL, PL,
PT, RO, SE,
SK
Pesticides
Heptachl
or /
Heptachl
or
epoxide
Past use as an insecticide to
control various insect pests,
and for soil and seed
treatment, wood protection.
Banned in the EU since 1984.
No ongoing commercial use.
AA: 2
10-7
MAC:
0.000
3
39 6
CY, DE,
ES, FR,
HR, IT
0.546 (0-20)
BE, CY, CZ,
DE, EL, ES, FI,
FR, HR, IT,
LT, NL, PT,
SK
Hexachlo
ro-
benzene
Past use as a fungicide for
seed treatment, especially on
wheat to control the fungal
disease bunt. Banned in the
EU since the early 1980s. No
ongoing commercial use.
AA:
n/a
MAC:
0.05
868 14
AT, CZ,
DE,
EL,ES,
FR, IT,
LT, NL,
NO, PL,
RO, SE,
SK
0.123 (0-1,000)
AT, BE, CY,
CZ, DE, ES, FI,
FR, HR, IE, IT,
LT, LV, LU,
MT, NL, PL,
PT, RO, SK
Tributylt
in
Past use as a biocide in anti-
fouling paints on ships and
boats. Banned. No ongoing
commercial use.
AA:
0.000
2
MAC:
0.001
5
1,988 18
AT, BE,
CZ, DE,
EL, ES,
FI, FR,
IT, LT,
LV, NL,
NO, PL,
PT, SE,
SI, SK
0.261 (0-100)
BE, CZ, DE,
ES, FR, LU,
MT, NL, PL,
SK
142
Based on pass/fail data reported by MS under the 2nd
RBMPs
225
Substance
Main uses / sources of
pollution
Curre
nt
EQS
for
inlan
d
surfa
ce
water
s
µg/L
No. of
WBs
with
EQS
excee
dance
No. of
MS with
at least 1
WB in
exceedan
ce142
(pass
/fail)
MS
reportin
g
exceeda
nces (as
pass/fail
status)
Indication of
current
concentrations
in surface
water
mean (min and
max) µg/L
MS providing
concentration
data
Industrial
chemicals
Dioxins
Mainly by-products of
industrial practices, e.g.
chlorine bleaching of pulp and
paper. Also formed during
combustion processes
(including smoking). No
commercial use.
AA:
n/a
MAC:
n/a
Unkno
wn
Unknown
Unknow
n
0.843 (0-580)
BE, BG, CY,
DE, EL, ES,
FR, HR, IT, IU,
NL, RO, SK
Fluorant
hene
PAH family member found in
crude oil and distillates. Use
as a binding agent in industrial
processes, in consumer
products such as clay pigeons,
and activated carbon, and in
professional uses such as road
construction. Ongoing
commercial use.
AA:
0.006
3
MAC:
0.12
2,367 17
BE, CZ,
DE, EL,
ES, FR,
HU, IT,
LT, LU,
MT, NL,
NO, PL,
RO, SE,
SK
0.552 (0-5,350)
AT, BE, BG,
CY, CZ, DE,
EL, ES, FI, FR,
HR, IE, IT, LT,
LU, LV, MT,
NL, PL, PT,
RO, SK
Hexabro
mo-
cyclodod
ecane
Used as flame-retardant within
insulation boarding, plastics,
and textiles.
AA:
0.001
6
MAC:
0.5
8 2 CZ, DE
(<LOQ (0.0001)
– 0.056)
CZ, DE
Hexachlo
ro-
butadien
e
Unintentional by-product of
the chemicals industry, e.g.
the manufacture of chlorinated
solvents, magnesium
production and incineration.
AA:
n/a
MAC:
0.6
811 11
BG, CZ,
DE, EL,
ES, FR,
IE, IT,
NL, NO,
SK
0.530 (0-100)
AT, BE, CY,
CZ, DE, ES, FI,
FR, HR, IE, IT,
LT, LU, MT,
NL, PL, RO,
SK
Nonyl
phenol
Past use in industrial processes
(e.g. for washing and dying of
yarns and fabrics) and in
consumer laundry detergents,
personal hygiene, automotive,
latex paints, and lawn care
products. Production and
majority of uses have been
restricted since 2003. No
ongoing intentional use but
imported textiles still an issue.
AA:
0.3
MAC:
2
986 11
CZ, DE,
EL, ES,
FR, HU,
IT, NO,
PT, SE,
SK
0.0863 (0.005-
0.15)
(based on only 4
data entries by 1
MS)
DE
Industrial
chemicals
PAHs
Unintentional by-products
from incomplete combustion
of organic materials. Oil
residues containing PAHs are
added to rubber and plastics as
a softener or extender.
Ongoing commercial use and
unintentional formation.
AA:
0.001
7
MAC:
0.27
3,926 19
AT, BE,
CZ, DE,
EL, ES,
FR, HU,
IE, IT,
LT, LU,
LV, NL,
NO, PL,
RO, SE,
SK
0.221 (0-2,180)
AT, BE, BG,
CY, CZ, DE,
ES, FI, FR, HR,
IE, IT, LT, LU,
LV, MT, NL,
PL, PT, RO,
SK
226
Substance
Main uses / sources of
pollution
Curre
nt
EQS
for
inlan
d
surfa
ce
water
s
µg/L
No. of
WBs
with
EQS
excee
dance
No. of
MS with
at least 1
WB in
exceedan
ce142
(pass
/fail)
MS
reportin
g
exceeda
nces (as
pass/fail
status)
Indication of
current
concentrations
in surface
water
mean (min and
max) µg/L
MS providing
concentration
data
PBDEs
Used as flame-retardants in
plastics, furniture, upholstery,
electrical equipment,
electronic devices, textiles and
other household products. Use
of lower order homologues
was banned internationally in
2004 and use of DecaBDE
should have ceased by 2021.
Primarily a legacy issue for in-
use stock and landfill.
AA:
n/a
MAC:
0.14
23,800 9
BE, CZ,
DE, EL,
FR, IT,
LV, SE,
SK
0.0465 (0-5)
DE, ES, FR,
LU, MT, PL,
SK
Metals
Mercury
Naturally occurring substance.
Wide range of uses, e.g. in
thermometers, barometers,
manometers, blood pressure
meters, float valves, mercury
switches, mercury relays,
fluorescent lamps and other
devices. Also forms during
combustion of fossil fuels.
Ongoing commercial use and
unintentional formation.
AA:
n/a
MAC:
0.07
46,780 25
AT, BE,
BG, CY,
CZ, DE,
EE, EL,
ES, FI,
FR, HU,
IE, IT,
LT, LU,
LV, MT,
NL, NO,
PL, RO,
SE, SI,
SK
3.54 (0-5,800)
AT, BE, BG,
CY, CZ, DE,
EE, EL, ES, FI,
FR, HR, HU,
IE, IT, LT, LU,
LV, MT, NL,
PL, PT, RO,
SE, SK
Nickel
Naturally occurring substance.
Used to make stainless steel
and other alloys, for plating,
foundry and batteries.
Ongoing commercial use.
AA: 4
MAC:
34
1,840 22
BE, BG,
CY, CZ,
DE, EE,
EL, ES,
FI, FR,
HU, IE,
IT, LV,
MT, NL,
NO, PL,
PT, RO,
SE, SK
627 (0-2 106
)
AT, BE, BG,
CY, CZ, DE,
EE, EL, ES, FI,
FR, HR, HU,
IE, IT, LT, LV,
MT, NL, PL,
PT, RO, SE,
SK
Substances considered for deselection143
Pesticides
Alachlor
Past use as an herbicide to
control grasses and weeds. No
longer approved for use in the
EU.
AA:
0.3
MAC:
0.7
488 10
BE, CY,
CZ, DE,
EL, ES,
FR, IT,
RO, SK
0.0674 (0.0003
100)
AT, BE, CY,
CZ, DE,ES, FI,
FR, HR, IT,
LU, MT, NL,
PL, PT, RO,
RS, SK
Chlorfen
-vinphos
Insecticide to control ticks and
biting insects for protection of
livestock. It has also been used
as an insecticide to protect
ground crops, such as potatoes
and vegetables. No longer
approved for use in the EU.
AA:
0.1
MAC:
0.3
809 7
EL, ES,
FR, IT,
PL, SE,
SK
0.122 (0.0005
500)
BE, CY, CZ,
DE, ES, FI, FR,
HR, IT, LU,
MT, NL, PL,
RO, RS, SK
143
Information in columns on the ‘No. of WBs with EQS exceedances’ and ‘No. of MS with at least 1 WB in exceedance’ is based on information
from the corresponding EEA dashboard(s)
227
Substance
Main uses / sources of
pollution
Curre
nt
EQS
for
inlan
d
surfa
ce
water
s
µg/L
No. of
WBs
with
EQS
excee
dance
No. of
MS with
at least 1
WB in
exceedan
ce142
(pass
/fail)
MS
reportin
g
exceeda
nces (as
pass/fail
status)
Indication of
current
concentrations
in surface
water
mean (min and
max) µg/L
MS providing
concentration
data
Simazine
Past use as an herbicide to
control grasses and weeds. No
longer approved for use in the
EU.
AA: 1
MAC:
4
1,292 5
DE, ES,
FR, IT,
SK
0.106 (0.00001 -
100)
AT, BE, BG,
CY, CZ, DE,
EL, ES, FI, FR,
HR, IE, IT, LT,
LU, MT, NL,
PL, RO, RS,
SK
Industrial
chemicals
Carbon
tetrachlo
ride
Primarily used as a solvent for
oils, waxes, resins, and runner.
Also used as an intermediate
in the manufacture of
refrigerants and propellants
for aerosol cans. Ongoing
commercial use.
AA:
12
MAC:
n/a
1,206 4
DE, FR,
IT, SK
1.206 (0.0002 -
87.58)
IT, PL, ES, DE,
BE, CY, CZ,
FR, HR, IE,
LU, NL, MT,
SK,
Trichlor
o-
benzenes
Family of chemicals primarily
used as solvents and chemical
intermediates for other
compounds. Sectors of use
include as solvent degreaser
(primarily for oils and waxes),
and to produce dyes and
textiles. Ongoing commercial
use.
AA:
0.4
MAC:
n/a
785 6
CZ, DE,
ES, FR,
IT, SK
0.510 (0.0001 -
100)
AT, BE, CY,
CZ, DE,EL,
ES, FR, HR,
IE, IT, LU,
MT, NL, PL,
RO, SK
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