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}



Contents 1Introduction: Political and legal context 2Problem definition 2.1What are the problems? 2.2What are the problem drivers? 2.3How likely is the problem to persist? 3Why should the EU act? 3.1Legal basis 3.2Subsidiarity: Necessity of EU action 3.3Subsidiarity: Added value of EU action 4Objectives: What is to be achieved? 4.1General objectives 4.2Specific objectives 5What are the available policy options? 5.1Methodology to select substances and set the quality standards 5.2Description of the policy options 5.3Options discarded at an early stage 6What are the impacts of the policy options and who will be affected?

6.1Impact assessment methodology 6.2Surface water – impacts of policy options 6.3Groundwater – impacts of policy options 6.4Monitoring, reporting and administrative streamlining – impacts of options 6.5Administrative burden 6.6Note on impacts for individual MS 7How do the options compare and what are the preferred options? 7.1Surface water 7.2Groundwater 7.3Monitoring, reporting and administrative streamlining options 8Preferred Policy Package 8.1Preferred options summary 8.2Overall magnitude of impacts 8.3One In, One Out 8.4REFIT 9How will actual impacts be monitored and evaluated? 9.1Indicators of success 9.2Monitoring and evaluation under the existing EU water quality legislation 9.3Joint monitoring and evaluation Annex 1: Procedural information

Annex 2: Stakeholder consultation (Synopsis report) Annex 3: Who is affected and how? Practical implications of the initiative Annex 4: Analytical methods used in preparing the Impact assessment Annex 5: Relations between ongoing initiatives and the present initiative Annex 6: Technical process for the revision of the List of Priority Substances and their EQS in Surface Water Annex 7: Technical process for the revision of the Lists of Pollutants in Groundwater Annex 8: Results of the quality standard derivation process for revision of the Annexes to the EQSD and GWD Annex 9: Detailed assessment of impacts per policy option Annex 10: Potential costs of selected surface water and groundwater pollution reduction measures Annex 11: Surface water monitoring data Annex 12: Literature References



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) 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 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 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 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 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”. 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.





11 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 sources. 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). 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.: ·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. 1107/2009 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 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 irrigation. ·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: oProposal 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’; oProposal 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 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 concluded 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. A possible revision of the lists of pollutants will also improve marine water quality and the quality of bathing waters. 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 all, SDG 3 on ensuring healthy lives and promoting well-being, as well as SDG 14 on protecting life below water. 22 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 overall, 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 2022. 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%. Figure B1.1: Chemical status of all surface water bodies for all priority substances per Member State (12) 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) 2.12.1 What are the problems? The problem definition rests mostly on the findings of the 2019 Fitness Check (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 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 2.1.12.1.1 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 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). 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. 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). 2.1.22.1.2 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 cycle. 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. 2.22.2 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. 2.2.12.2.1 Gaps in the legal framework

2.2.1.1Emerging 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. 2.2.1.2Pollutant 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 additively, synergistically or antagonistically 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). 2.2.1.3Seasonal 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. 2.2.22.2.2 Inefficiencies of the legal framework 2.2.2.1Flexibility Surface and groundwater pollution is a problem in many parts of Europe, 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 RBSPs 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 EU. 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 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. 2.2.2.2Resource 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.

2.32.3 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 with science, as well as a lack of harmonisation, inconsistent implementation, and burdensome data management due to lack of adaptation to digital progress. 2.3.12.3.1 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). 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 countries 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). 2.3.22.3.2 Persisting microplastics pollution 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 ). 2.3.32.3.3 Persisting pharmaceuticals pollution Pharmaceutical products (mainly medicinal products, but also other personal care products) can act as environmental contaminants (38) (39) (40) (41) (42). 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 works. 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 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 policies 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 List, 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. Figure B6.1: Status of actions under the Strategic Approach to Pharmaceuticals in the Environment

2.3.42.3.4 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 annum, whereas ECHA information from 2018 indicates that the current manufacture and use of silver amounts to between 100,000 – 1,000,000 tonnes /year. The use of silver is steadily increasing (year-on-year increases vary between 5-13% in recent years). 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). 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 effects. Consequently, they are important as a ‘last’ resort for treating infections with multi-resistant bacteria. 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 species. 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 . 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-fold. 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-selection, e.g. by reserving the use of silver based antimicrobials only for treating infections, in order to preserve its efficacy. 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-emissions. 2.3.52.3.5 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), 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 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. 2.3.62.3.6 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. 2.3.72.3.7 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. 33 Why should the EU act?

3.13.1 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 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. 3.23.2 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 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). 3.33.3 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. 44 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. . 4.14.1 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.

4.24.2 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). 55 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. 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. 5.15.1 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. 5.1.15.1.1 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 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. 5.1.25.1.2 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. 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, 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. 5.25.2 Description of the policy options 5.2.15.2.1 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 groups) 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 (