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

Glossary

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 1 . By reducing pollution at source and by treating water before release into the environment, many past pollution problems were tackled successfully. However, the EU’s water bodies are still at risk from certain hazardous substances, which can affect ecosystems and threaten human health. And new pollutants of concern are emerging.

This initiative is part of the Commission Work Programme 2022 and a key action in the Zero Pollution Action Plan (ZPAP) 2 . This initiative, like all EGD-initiatives, aims at ensuring that objectives are achieved in the most effective and least burdensome way, and comply with the ‘do no significant harm’ (DNSH) principle (see glossary for the water related details). It fine-tunes, updates and adapts existing legislation in the context of the EGD. Its focus is on defining the zero pollution ambition for water pollutants and thereby the level of protection for human health and natural ecosystems. The measures necessary to achieve this level of protection are addressed by several other, closely related, initiatives under the European Green Deal, e.g. 3 :

·The Biodiversity and Farm to Fork Strategies, which aim to reduce pesticide use, nutrient losses, and sales of antimicrobials (by 50%), as well as fertilizer use (by 20%) by 2030. Much of it is to be achieved by the ongoing revision of the Directive on the Sustainable Use of Pesticides . The upcoming review of Regulation (EC) No. 1107/2009 4 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 5 .

·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 6 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 7 . 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 8 , SDG 3 on ensuring healthy lives and promoting well-being 9 , as well as SDG 14 on protecting life below water 10 .

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 11 , 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 12 .

2.12.1    What are the problems? 

The problem definition rests mostly on the findings of the 2019 Fitness Check 13 (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.

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).

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.

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.

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 16 , synergistically 17 or antagonistically 18 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 19 , 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 20 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 21 . 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.

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) 22 . The persistence, mobility and bio accumulative nature of PFAS leads to negative effects for human health and biodiversity. The bio-accumulative effects are e.g. illustrated by the results of an EU LIFE project which showed that Per-fluoro-octane sulfonic acid (PFOS, one of the many PFAS substances, used in stain repellents, impregnation agents for textiles, paper, and leather; in wax, polishes, paints, varnishes, cleaning products for general use, in metal surfaces, and carpets) concentrations in the livers of top predators are severely elevated compared to those present in the fish they eat.

Apart from PFAS used in firefighting foam, PFAS emissions from coatings of carpets, clothes, furniture, and paper (incl. food packaging), land spreading of residues from the paper industry, car wash facilities, etc. will continue to cause water related environmental and health concerns. Many countries 23 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

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 24 . 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 25 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).

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 27 , whereas ECHA information from 2018 indicates that the current manufacture and use of silver amounts to between 100,000 – 1,000,000 tonnes /year 28 . The use of silver is steadily increasing (year-on-year increases vary between 5-13% in recent years) 29 .

This substance is used in the following products: metals, welding & soldering products, metal surface treatment products, adhesives and sealants, biocides (e.g. disinfectants, pest control products), coating products, laboratory chemicals, lubricants and greases, metal working fluids and pharmaceuticals. The antibacterial activity of silver has led to an increased use of silver in an ever wider range of consumer products. The different forms of silver, including silver salts(e.g. silver nitrate), silver oxides and silver materials appear as silver wires, silver nanoparticles (Ag-NP) and others, which are used in consumer and medical products. In medical care, forms of (nano)silver are used, for example in wound dressings and catheters to reduce infections. In consumer products, forms of (nano)silver are used, for example in sports and other textiles, washing powders and deodorants, where (nano)silver should reduce odours producing bacteria.

Products containing silver (in ionic form and as nanoparticles) can act as environmental contaminants in general and in relation to the development of anti-microbial resistance. Releases into the environment of silver are likely to occur from industrial use: in the production of articles and manufacturing of the substance. Other releases to the environment of silver are likely to occur from: indoor use in long-life materials (e.g. flooring, furniture, toys, construction materials, curtains, foot-wear, leather products, paper and cardboard products, electronic equipment) and outdoor use in long-life materials (e.g. metal, wooden and plastic construction and building materials) (ECHA, 2021). A number of silver substances are under evaluation under the Biocides Regulation (EU) No 528/2012 (BPR) . Some of the biocidal product types under which the substances are notified require the deliberate release of silver into water in order to exert the claimed effects, for example for human hygiene, disinfection of food and feed areas, disinfection of drinking water or the prevention of pathogens in cooling systems. Other applications may result in release of silver into the environment via the sewage system or when exposed to rain outdoor, for example preservation of paints or preservation of fibre, leather, rubber and polymerised materials.

When evaluating the end-of-life phase of silver containing products, it is assumed that their waste management (recycling, wastewater treatment, landfilling, and incineration) is similar to conventional products. Consequently, silver content in non-recycled waste ultimately ends up in the environment, as waste in landfills, emissions from wastewater treatment plants, or as residual waste from incineration plants.

According to ECHA information based on REACH dossiers, and tests performed with the smallest nanoform with the highest specific surface area, have indicated that silver nitrate (ionic silver) is more toxic than the nanoform of silver (toxicity to algae and long-term toxicity to aquatic invertebrates) and that silver nitrate is equally or more toxic than the nanoform of silver (toxicity to soil microorganisms).

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 30 . Consequently, they are important as a ‘last’ resort for treating infections with multi-resistant bacteria 31 . 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 32 . Currently, silver still has proven bactericidal activity towards this bacterium even against strains that display multi-drug resistance. Therefore, it is of utmost importance to avoid /limit silver resistance in bacteria to avoid limiting its effectiveness in treatments for infectious diseases. With the rise of antibiotic resistant bacteria, there are also serious concerns of pathogens developing resistance to silver.

An OECD project focusing on availability of vitro methods for the assessment of the genotoxic potential of nanomaterials, by specific testing of nanomaterials in a stepwise approach, evaluated the uptake of selected representative nanomaterials and their in vitro cytotoxicity. For silver it was demonstrated that silver NMs induced cytotoxicity to various degrees depending on the sensitivity of the used cell line  33 . While resistance to ionic silver is recognised for many years, many scientific studies also demonstrate increasing bacterial resistance to silver. Some resistance related mutations in bacteria are uniquely associated with resistance to NAg, while others are protective against both NAg and ionic silver. These mutations continued to be detected after the silver exposure had stopped, indicating that heritable resistance characteristics continue to spread even after discontinued silver use. This shows that silver cross-resistance occurs, and indicates the importance of avoiding heritable silver resistance. Avoiding Ag-resistance is extra relevant as scientific evidence demonstrates that, bacteria pre-exposed to sublethal dose of silver also exhibited increased resistance toward antibiotics (ampicillin and Pen-Strep) with the half maximal inhibitory concentration (IC50) elevated by 3 to 13-fold 34 . 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 35 , e.g. by reserving the use of silver based antimicrobials only for treating infections 36 , 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 37 .

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) 38 , have been identified (51) in many surface water and groundwater bodies across the EU. New nrMs are emerging, whilst concentrations of known nrMs are increasing. Also, the impact of cocktail effects on (ground)water quality, i.e. from mixtures of various substances (incl. nrMs), remains unaddressed in the absence of EU action. Monitoring results from recent SW WL show increasing concentrations of pesticides across the EU. For groundwater ecosystems the 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.

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).

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

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 39 ) they should be listed, therefore constituting an “either-or” selection as they represent different approaches for the same candidate substances. Policy options 3 and 4, on the other hand, are independent of all other options and the choice there is only whether, for each of the substances involved, the respective option should be implemented. The recommended EQSs for each substance or group of substances under Options 1, 2 and 3 are listed in Annex 8.

When looking at possible policy measures to address substances that are included in the substance lists under the Directive, it is important to differentiate between PS and priority hazardous substances (PHS) since the regime of possible measures is different. Measures for PS are mainly aimed at reducing emissions in view of complying with the EQS values, whereas measures for PHS are aimed at phasing out emissions entirely. From all the candidate substances under consideration, only PFAS and Bisphenol A (BPA) meet the criteria for PHS status.

Table 5.2.1: Surface water policy options

It should be noted that the legislation currently provides MS with a period of time to comply with the newly listed substances and the modified TVs, going beyond the 2027 deadline for achieving good chemical status set in the WFD. For revised surface water EQS this additional time was set 40 at 6 years (2021, plus 12 more years in case of technical infeasibility or disproportionate cost). For new surface water substances, it is 12 years (2027, plus 12 more years in case of technical infeasibility or disproportionate cost).

5.2.25.2.2    Groundwater policy options

Three policy options have been developed to address the pollution of groundwater by PFAS, pharmaceuticals and nrMs. The major policy choice is whether to add these emerging contaminants to Annex I (as individual substances or groups) or Annex II of the GWD. Additions to Annex I must be accompanied by an EU-wide groundwater quality standard (currently covered are nitrates, pesticides and their relevant metabolites), whilst substances added to Annex II must be considered by MS during the risk assessment phase of river basin management planning, and appropriate TVs set at national level.

The options, listed in Table 5.2.2 , represent an “either-or” choice for each of the substances (or groups of substances), which are assessed independently of each other under each option. The SCHEER endorsed quality standards are based on available (eco)toxicological data, harmonised with surface water quality standards in several cases, and, where necessary, the precautionary principle. All of the options address specific objective 1 of this initiative.

Table 5.2.2: Groundwater policy options

5.2.35.2.3    Monitoring, reporting and administrative streamlining options

To address specific objectives 2 to 5 of this initiative, 15 discrete actions were identified. These were categorised into four groups of policy options based on their subject matter (e.g. monitoring, reporting) and nature (e.g. voluntary, legislative). Table 5.2 . 3 lists the four policy options and the respective specific sub-options considered under each. The four thematic policy options are not mutually exclusive and all the (sub)options can be implemented in combination with each other within and across these groupings. All these (sub)options are complement the surface and groundwater-specific options described above.

Providing / improving guidance and advice on monitoring, including Effect Based Methods (EBMs), modern instruments, digital techniques etc., is necessary to address the significant pressures stemming from emerging pollutants (such as microplastics) and possible cumulative effects of pollutant mixtures. Regarding microplastics, no commonly agreed standard for measuring their presence in EU freshwaters exists. Such a standard is, however, a prerequisite for monitoring and taking targeted policy action like setting an EQS/GW QS. In addition, there are a range of innovative monitoring techniques, including automated sensing technologies, which could provide important insights into pollutant levels, but which are yet to be commonly adopted. Improved sharing of knowledge and best-practices among MS may help facilitate wider implementation of such innovative methods.

Establishing / amending existing obligatory monitoring practices is needed to gather more specific evidence on the evolution of pollution. Mandatory monitoring would help fill the existing data gaps (e.g. on the combined effects of estrogenic substances, emerging pollutants in groundwater, seasonal variations of emissions in surface waters) and inform future risk assessments.

Actions to harmonise / simplify reporting and classification would improve transparency and access to data as well as reduce the administrative burden of MS in the medium and long term.

The legislative and administrative changes are needed to enable more effectiveness, efficiency, coherence, responsiveness and flexibility in the legislation.

Table 5.2.3: Policy options related to monitoring, reporting and administrative streamlining

5.35.3    Options discarded at an early stage

For the identification of possible policy measures, a two-step approach was used. In a first step, a wide range of possible measures were identified. For each problem, different solutions were envisaged, ranging from soft approaches - mainly based on non-binding guidance to MS - up to stricter regulatory measures. In a second step, based on a 'feasibility’ screening, a selected number of possible policy measures were retained for further analysis.

The option of not updating other aspects of this legislation that are not directly linked to chemical pollution was discarded early on, given the outcomes of the FC and the political commitment not to seek a change in the WFD in the short run. Also rejected was the option in relation to targeted substances to directly ban certain pharmaceuticals, pesticides or other chemicals. In all these cases the EU has a well-functioning system of risk-screening before market authorisation for their intended use. Therefore, while possibly effective from an environmental standpoint, these options would be inconsistent with the established policy approaches. As regards substitutes for potential new substances, the impact assessment did not consider substitutes that are over 3.5 times more costly than the original substance, as beyond this price difference they are no longer regarded as a realistic substitute (substitutes considered are detailed in Annex 10).

66    What are the impacts of the policy options and who will be affected? 

This section describes the impact assessment methodology, discusses the impacts of policy options and stakeholders particularly affected by them. The assessment of the addition or removal of substances or groups of substances selected through the methodology described in Chapter 5.1 has been based on the distance to target, including application of the dynamic baseline, and an assessment of additional measures that might be needed to achieve the recommended quality standards (listed in Annex 8).

Note that EU water legislation does not specify exact measures to be taken to reach a given water quality standard. Therefore, the assessment of possible costs and benefits of policy options is based on the potential measures that MS might take because of this initiative, additionally to the existing measures and any requirements imposed by other EU legislation.

It is not possible, in this impact assessment, to identify the isolated cost and benefit of listing substances since this will depend on measures chosen by MS and on distance to target in the concerned water bodies. Moreover, water legislation works in sync with other legislation (waste water treatment, source control, international requirements, etc). Figures in this section and in section 8 are therefore often related to estimated costs / benefits from groups of substances with similar characteristics or effect (eg cost of removing all PFAS, or all health effects of hormone disturbing chemicals) but are not to be understood as costs and benefits solely associated with this initiative.

A more detailed overview of impacts, for each of the surface water and groundwater options, can be found in Annex 9.

6.16.1    Impact assessment methodology

6.1.16.1.1    Distance to target

An important factor to understand the impacts of adding new substances to the lists of pollutants or amending existing EQS values is the ‘distance to target’. This refers to the size of the gap between the baseline situation and the target considered within the policy option. The indicative assessment of the potential exceedances above the envisaged limit values helps evaluate the likely extent of measures required to address the issue.

The ‘distance to target’ assessment followed a two-step process. First, the substances considered under each option were assigned to groups (large / medium / small) based on the predicted geographic scale (i.e. how many water bodies might fail chemical status; how many MS might need to take measures) and the magnitude (i.e. how far above the thresholds do concentrations rise) of the current gap. The general criteria for these groupings is shown in Table 6.1 . 1 with further caveats (e.g. specificities for SW and GW assessment) explained in Annex 4.

Table 6.1.1: General scale and magnitude criteria for the distance to target assessment

There is currently not enough detailed information to allow the distance to target to be determined for each Member State vis-à-vis each substance or group of substances under consideration. Indeed, the monitoring data underpinning such measurement (typically gathered from the SW WL, the GW WL and the WFD reporting) are in a number of cases incomplete. In such cases, extrapolation considering authorisation, use and emission data, and expert judgement are used to obtain an indication of the existing scale and magnitude of pollution (see Annex 4 for details).

Secondly, the dynamic baseline assessment (described in Chapter 0) was taken into account to reflect the expected change in emissions due to other (policy) drivers. The final distance to target, therefore, reflects the additional EU-wide effort that may be required to tackle the pollution caused by the candidate substances. Where there are no EU-wide measures introduced by other policy initiatives, MS will have to take action nationally, and the (large / medium / small) distance to target indicates the average relative effort required to tackle the relevant substances. Results of the distance to target assessment are presented in dedicated surface and groundwater sections below.

6.1.1.1Surface water

The distance to target for surface water Option 1 (addition to PS list individually) and Option 2 (addition to PS list as groups) has been determined using a combination of monitoring data gathered from the SW WL and the assessment conducted within the EQS dossiers. The baseline situation is represented by the current concentrations measured in surface water, whereas the target is the value considered protective of human health and the aquatic ecosystem (i.e. the scientifically recommended EQS; see Annex 8).

An overall relatively large distance to target was estimated for 3 pharmaceuticals (17 alpha-ethinylestradiol (EE2), Diclofenac, Carbamazepine), Silver, 5 pesticides (Bifenthrin, Deltamethrin, Esfenvalerate, Permethrin, Glyphosate) and 2 industrial chemicals (PFAS, Bisphenol A).

An overall medium distance to target was estimated for 4 pharmaceuticals (17 beta-estradiol (E2), Estrone (E1), Azithromycin, Ibuprofen), 2 pesticides (Imidacloprid and Triclosan) and 1 metal (silver and its compounds).

An overall small distance to target was estimated for 2 pharmaceuticals (Clarithromycin, Erythromycin), and 5 pesticides (Acetamiprid, Clothianidin, Thiacloprid, Thiamethoxam and Nicosulfuron).

A slightly amended approach was used to assess the distance to target for surface water Option 3 (EQS amendment), because the impact assessment looked at possible additional efforts required to tackle these substances once their EQS is amended. The baseline situation is, therefore, represented by the current gap between concentrations measured in surface water and existing EQS, whereas the target is the new scientifically recommended EQS.

The scale and magnitude of the current gap has been determined using a combination of monitoring data gathered from the WFD reporting and the assessment conducted within the EQS dossiers. Then, based on the new recommended EQS (where available, see Annex 8) and guidance from the JRC, an assessment has been made as to whether the size of the gap would increase, decrease, or stay the same following EQS amendment. Afterwards, as for other policy options, the impacts of the dynamic baseline (see Chapter 0) were taken into account to re-group substances.

An overall relatively large distance to target was estimated for 1 industrial chemical group (PBDEs) and 2 metals (Mercury, Nickel).

An overall medium distance to target was estimated for 4 pesticides (Chlorpyrifos, Cypermethrin, Diuron, Tributyltin) and 2 industrial chemical groups (Dioxins and furans, PAHs).

An overall small distance to target was estimated for 3 pesticides (Dicofol, Heptachlor / Heptachlor epoxide, Hexachlorobenzene) and 3 industrial chemicals (Fluoranthene, Hexachlorobutadiene, Nonylphenol).

6.1.1.2Groundwater

Unlike the surface water situation, an EU-wide monitoring network of emerging groundwater pollutants does not exist. Therefore, the likely current day status of groundwater bodies (GWBs) with respect to the LFR pollutants is needed to understand how much effort might be required to reach the targets proposed by the various policy options. This baseline assessment was made by reviewing the most recent reported status of GWBs (i.e. 2nd River Basin Management Plans covering the 2015-2021 period) and the chemicals leading to failure with similar emission characteristics and environmental fate along pathways to groundwater. The scale was represented by % of MS likely to report failure, whereas the magnitude was defined as the level of exceedance above TVs already used by MS for the proxy substances.

Then, the expected distance to target was assessed based on expert judgement and the indication of the likely level of exceedance over the potential PFAS, pharmaceuticals and nrMs TVs. The level of exceedance is estimated by calculating the proportion of monitoring locations and MS reporting concentrations above the targets stipulated in the policy options. Afterwards, the impacts of the dynamic baseline (see Chapter 0) and the lag-time of groundwater ecosystems were taken into account to adjust the grouping. For example, although PFAS emissions are expected to reduce significantly due to other policy interventions, this will be reflected in groundwater concentrations much later, therefore having no impact on distance to target before 2030.

An overall relatively large distance to target was estimated for PFAS under all options as well as nrMs under Option 1 (all individually in Annex I).

An overall medium distance to target was estimated for pharmaceuticals under Option 2 (group of all in Annex I), and nrMs under Option 2 and Option 3 (addition in Annex II).

An overall small distance to target was estimated for pharmaceuticals under Option 1 (carbamazepine and sulfamethoxazole in Annex I) and Option 3 (group in Annex II, considering Primidone).

6.1.26.1.2    General considerations for all surface and groundwater options

Impacts of the policy options related to the (de)listing of surface water and groundwater substances are dependent on the specific measures taken to reduce the presence of pollutants. Measures come in four groups: source control (e.g. substitution, bans, emission prevention at production stage), pathway disruption (physical barriers preventing/reducing pollution to surface and ground-waters), end-of-pipe 42 (in this case treatment measures preventing/reducing pollution at the waste water stage) and finally monitoring and risk attenuation at water bodies’ level.

Key sectors likely to be impacted by groups of measures were identified. In many cases, the same measures are effective for addressing multiple substances in a complementary fashion. The importance of different measure categories varies depending on the substance. Table 6.1.2 provides a quick reference for how the measure categories relate to the substance categories. Then, an overview of stakeholders possibly impacted by the implementation of identified measures is presented in .

Table 6.1.2: Overview of measure categories and substance categories

*Relates to agricultural runoff from farmed animals only **Legacy uPBT pesticides only ***related to run-off from road only

Table 6.1.3: Overview of stakeholders likely impacted by measures identified (surface and groundwater)

6.26.2    Surface water – impacts of policy options 

This section provides a summary of the associated environmental, economic and social impacts of individual policy options. The evaluations of the Industrial Emissions Directive (IED) and the EU Pollution Release and Transfer Register (E-PRTR), pieces of legislation with which the WFD interacts strongly, notably on water management, concluded that industrial installations, covered by the IED /E-PRTR, account for about 20% of pollutant emissions by mass to water this includes among others the main groups of pollutants covered by this evaluation (pharmaceuticals, industrial substances, and metals). For pesticides the picture is different since the main emitter of those substances is the agricultural sector who is the end-user of the products produced by industry.

6.2.16.2.1    Policy option 1 – listing candidate PS individually

Option 1 applies to all substance categories (industrial/pharmaceuticals/pesticides/metals).

Industrial chemicals (PFAS and Bisphenol-A)

Important sources of PFAS emissions are the primary manufacturers of manufacturers of fluorochemicals and/or fluoropolymers, as well as cardboard and paper mills producing PFAS coated paper for a myriad of applications. The number of PFAS production sites in Europe is between 12 and 25 plants (25). Also, based on Eurostat data on the basis of NACE codes, nine additional industrial activities where PFAS are likely used (textiles, leather, carpets, paper, paints and varnishes, cleaning products, metal treatments, car washes, plastic/resins/rubber) were identified. Also, regarding environmental discharges from paper mills, it is estimated that a “typical” paper mill that produces 825 tons of PFAS-coated paper per day and discharges 98.4 million liters of water per day which release more than 100,000 ppt of PFAS in the wastewater effluent (55). Consequently, paper mill companies estimated a release of 43 to 102 kg of PFAS per day in their wastewater 43 . With 743 EU paper mills (56) this results in daily PFAS emissions between 31 to 76 tonnes. Companies also state that for 10 kg of PFAS going from the manufacturing process into wastewater treatment, 9 kg end up in biosolids and 1 kg is released into surface waters (57). That means the amount of PFAS ending up in sludges across the EU ranges from 310 to 760 tonnes/day. PFAS can only be effectively removed from wastewater by reverse osmosis with operating costs of €0.4 /litre. A cost model calculating the capital costs for building PFAS drinking water remediation resulted in baseline capital cost of $712,752 plus $2,070,142 per million gallons/day (MGD) which is simplified to $2 million per MGD which equals €520/m3/day. Measures at source would thus avoid costs at least €39.4 million EU-wide related to a complete removal of PFAS from paper mills effluents/sludges. Note: the EU has comparatively limited information on (industrial) point sources of PFAS emissions from production and manufacturing sites because many industrial installations do not have to monitor PFAS under their discharge permits. Consequently, US information (58) (59)  (60)  (61) was used.

In 2018, a car wash facility in the US state of New Hampshire was cited as one of the sources of PFAS contamination in wells serving several nearby towns (62). Investigators tested wells on the car wash property and found levels for PFAS higher than expected – up to 158.8 ppt, compared to the USEPA lifetime advisory level of 70 ppt. The facility will be required to take measures to prevent the contamination from continuing. According to the International Car Wash Association 79,000 car wash facilities are operating in Europe. These are likely to be SMEs employing less than 250 workers (63). It is not known how many of these use products containing PFAS.

The industrial chemical Bisphenol-A (BPA), is produced in large quantities for use primarily in the production of polycarbonate plastics. It is found in various products including shatterproof windows, eyewear, water bottles, and epoxy resins that coat some metal food cans, bottle tops, and water supply pipes. For the environment, contaminated landfill leachate is an important source for both SW and GW. Consequently, an improved capture of landfill leachate combined with wastewater treatment could prevent in the order of 246MT of leachate being emitted. Annual costs associated to this measure are estimated to amount around €103.7 million, with an assumed 25-year asset lifetime. Avoided economic health related costs for avoided BPA exposure in relation to childhood obesity are estimated to amount to around €1831 44 million (64). Recent findings from EHCA (65) also support a further restriction of BPA emissions. For human health, BPA in food and beverages accounts for the majority of daily human exposure. BPA can leach into food from the protective internal epoxy resin coatings of canned foods and from consumer products such as polycarbonate tableware, food storage containers, water bottles, and baby bottles. Lowering human health risks comes at little to no costs, since exposure can be easily limited by behavioural changes such as not microwaving polycarbonate plastic food containers, reducing the use of canned foods, and when possible, opt for glass, porcelain or stainless steel containers, particularly for hot food or liquids and finally choosing to use (baby) bottles that are BPA free.

Pharmaceuticals

Source control measures like restricting/reducing the use of candidate pharmaceuticals within the human population, e.g. by substituting the most harmful pharmaceuticals by less harmful alternatives (greening pharmacy), or by changing from over-the-counter to prescription-only systems, will be important to limiting their emissions. Additionally, the management of unused, expired medicines /medicine containers to prevent the substance entering wastewater systems and/or landfills (see Box 13) could also be improved. Furthermore, new EU Ecolabel criteria for cosmetics and animal-care products (adopted in October 2021) offer proof to consumers that they purchase products with MSverified environmental excellence, along the entire life cycle 45 . Price impact for consumers will be limited since alternatives to listed substances are available at little or no additional cost.

The use of pathway disruption measures like buffer strips (costs €160 per hectare) or natural constructed wetlands (costs €43.7 per m3) are identified as potential cost-effective measures for reducing the entry of estrone (E1) and 17-beta estradiol (E2) into the environment. Under a worst-case scenario, a maximum of 5% of all pastoral farmland would be assumed to require measures (buffer strip /constructed wetland / additional fencing. End of pipe measures directly relate to the revision of the UWWTD. The costs to remove micro-pollutants from waste water under that legislation are shown in Table 6.2 . 1 : Overview of measure categories and substance categories .

Table 6.2.1: Overview of measure categories and substance categories

As regards pharmaceuticals, depending on policy measures at national level, choice of specific medication may be limited through different prescription policy.

For carbamazepine, diclofenac and ibuprofen a range of (cheaper) alternatives exist. Technical challenges related to manufacturing and supply chains (increasing supply of alternatives), and issues related to the prescription of alternatives exist for some substances. Also, for specific individual patients the substitution of specific medicines might not be feasible and could thus limit the impact on emission reductions. For veterinary uses, pathway disruption could also help reduce diffuse emissions to surface water.

End of pipe measures to remove pharmaceuticals from waste water are relatively costly and thus not preferred, but could be helpful for ibuprofen and carbamazepine. Ozonation could help to remove macrolide antibiotics. Diclofenac is more costly to remove. The revision of the UWWTD IA shows that the deployment of enhanced water treatment technology results in considerable additional resource and energy costs (resulting in a significant increase of the associated carbon footprint). Also, the undesired formation of bromide as unwanted breakdown product is relevant for some substances. Annex 10 contains overview tables with pharmaceutical substances, potential alternatives and the costs of each as well as tables with an overview of the most common end-of-pipe measures and their cost per substance.

Increasing interest for surface and groundwater pollution by pharmaceuticals is fuelling interest in developing new pharmaceuticals – or re-designing existing ones – to be more environmentally friendly, or ‘benign by design.’ This includes drugs that are better absorbed by the human body, or that biodegrade more rapidly in the environment. For example, by structurally modifying propranolol – a commonly used and highly persistent beta blocker – researchers have been able to synthesise a derivative that breaks down much more easily in the environment than its parent compound 47 .

Green Pharmacy initiatives are already operating in a large number of MS. New Green Pharmacy initiatives and actions, e.g. consisting of return schemes for unused and disposed medicines, will expectedly strongly benefit SMEs and start-ups. Cost of those initiatives are estimated to range between €1-10 million per MS. Local pharmacies / chemists and research institutes are important players in such initiatives that boost innovation and employment including in SMEs. In the pharmaceutical sector, SMEs drive innovation and play a major role in the development of new medicines. More than 4 out of 10 medicines selected for Environmental Medicine Agency priority medicines scheme were from SMEs 48 . Therefore, the push for substitutes will likely benefit those SMEs in the pharmaceutical sector.

In the cosmetics and personal care products sector, SMEs also play an important role. In 2020 France had 840 small and medium-sized enterprises (SMEs) specialized in the manufacturing of cosmetic products followed by Italy (735), Poland (606), Spain (515), Germany (348) 49 .

Also, the EU-funded research projects such as ‘Implementation of Research and Innovation on Smart Systems Technologies’ (IRISS) have helped innovation and supported EU efforts to extend competitive advantages of European research institutes and industry (e.g. the Institute for Sustainable Chemistry, the Fraunhofer Institute, Starlab Barcelona, Siemens, Hitachi and other partners) related to Smart Systems research e.g. to help reduce hazardous substances in production in the textile and plastics industries (66). Such projects, illustrate that ‘Safe by Design’ concepts increasingly find their way into politics and the chemical / pharmaceutical and personal care products industry (67).

Pesticides

For pesticides, emissions are best limited by a combination of use restrictions, replacement by less harmful alternatives, pathway disruption (e.g. buffer strips) and end-of-pipe measures.

The most important pathway to the (aquatic) environment is run-off from fields. Consequently, on-farm measures are the most effective. Currently 1472 active substances, safeners and synergists are registered in the EU pesticides database (68). This implies that there are numerous approved authorised active substance that can be used to identify less harmful substitutes to replace more harmful pesticides.

Less toxic chemical alternatives for pyrethroids are limited (often other pyrethroids). For imidacloprid and triclosan (neonicotinoids) the primary uses relate to the use as a biocide and associated losses to the aquatic environment often to sewer. Imidacloprid is used to controls fleas and ticks in domestic pets. Primary chemical alternatives for imidacloprid are likely pyrethroids, which may present some issues for certain animals sensitive to them (69). Triclosan is mainly used in medicated soaps / disinfectants, for which substitution by less harmful alternatives is realistic. Silver is commonly used as a substitute, but also has risks. Annex 10 lists several pesticides, potential alternatives, and estimated costs of alternatives.

The use of physical barriers is not at saturation level in the EU yet and could thus be envisaged by MS. Calculations undertaken to help derive indicative (orders of magnitude) of costs attributed to the use of pathway disruption for pesticides is included in Annex 10.

For biocidal uses, particularly within indoor settings, the potential wash-off or rinsing to drains during cleaning and maintenance is an issue. Consequently, end-of-pipe measures for those specific uses can have an added value. Annex 10 provides the results of indicative cost estimates for the removal of several substances in use as biocides. The IA for the revision of the UWWTD indicates that ozonation could be reasonably cost effective to remove imidacloprid. Removing triclosan requires reverse osmosis (RO) which is costly and challenging to implement at local level. Removing Acetamiprid, Thiamethoxam, Permethrin requires Granulated Activated Carbon (GAC) which is also expensive. Reverse osmosis investment costs are estimated around €100,000 to €10,000,000 per plant, with operating costs of €0.4 per dm3 (71). Also, RO results in an additional 20% water extraction needed to prepare drinking water (due to the requirement for membrane flushing/cleaning), which will add to existing water shortage pressure in many MS.

The main costs in relation to the reduction of pesticides in surface- and groundwater are expected to be covered by the implementation of the revised legislation on the sustainable use of pesticides directive (SUPD). According to the SUPD evaluation there have been no remarkable drops in pesticide sales, or losses since 2009.

Reducing concentrations of pesticides and chemicals overall in GW and SW will reduce costs of the drinking water purification sector, an important share of which are SMEs. SMEs are for example active in monitoring and testing of (drinking) water and data analysis. EU wide treatment costs amount to 510 million EUR per year. If, in line with the targets of the F2F strategy, pesticide use is decreased by 50%, treatment costs decrease accordingly by 205 million/year. Corresponding costs savings for consumers are then around EUR 5-10 per person/year (see Annex 3 for more details).

According to the progress report from the European Commission on the implementation of the EU Pollinators initiative (72) the economic value of pollinating insects to crop production in the EU is at least 3.7 billion EUR per year. New research shows pesticides are contributing to the decline in pollinators. In particular the neonicotinoids are very toxic and persistent and contribute to the loss of honeybees. Quite a number are known to be directly toxic for bees and co-responsible for bee poisoning and bee death, like e.g. Imidacloprid, Clothianidin, Thiacloprid, Thiamethoxam, Dinotefuran, Nitenpyran, Fipronil, and Oleofin. Neonicotinoids are extremely toxic to bees. LD50 rates (the rate at which half of the exposed population dies) for clothianidin are 22-44 nanograms per bee for direct contact and 2.8-3.7 nanograms per bee for oral ingestion. In other words, a single corn kernel with neonicotinoid seed treatment potentially contains enough active ingredient to kill over 80,000 honey bees (73) (74). Some scientific studies show that bumblebees exposed to neonicotinoids have at least 10% smaller colonies than those not exposed to the insecticide, others report a 57% decline in reproduction rates (75), with pesticide exposure having the greatest impact on nesting activity and the number of offspring the bees produced. Assuming that between 10% or 50% of the economic losses from pollinator decline are attributed to pesticide toxicity 50 , this results in mean annual benefits of EU and MS action on such pesticides (one of which is the current proposal) from 370 million to 1.85 billion EUR (see Annex 3 for more details).

Pesticides users are almost exclusively SMEs (farmers, landscapers, etc). As regards the production and production and marketing side, while a large number of SMEs are active here as well (fastest growing segment companies with 50-250 employees, the sector is dominated by very large companies, with 88% of the market share for the top 7 crop protection companies in the EU 51 . Impacts will depend heavily on the types of measures taken by MS to ensure compliance with the legislation. If users need to revert to alternative pest management methods or alternative pesticides this may lead to lower yields or higher costs. If the policy measures lead to a drive for innovation, both SMEs and large companies on the development and production side will profit.

Metals

For silver and its compounds, a myriad of sources and pathways to environment exist. For anthropogenic activities like smelting, combustion of coal, manufacturing of silver containing products, source control options consist of increased abatement and monitoring. Silver is used widely as antibacterial agent in medicinal, personal care and other consumer products. The widespread use of silver has already led to the release and accumulation of the AgNPs in water and sediment, in soil and even, wastewater treatment plants (WWTPs) and is thus impacting microbial communities in different environmental settings. Scientific evidence of silver-driven co-selection of antibiotic resistance determinants is also numerous.

The resistance mechanism for nanosilver (NAg) is linked to indicated to increasing environmental antibiotic resistance gene pools indicated by the many antibiotic resistance genes already detected in samples from different environmental settings. These antimicrobial resistance genes could ultimately find their ways to animals and humans. This is worrisome, as the increasingly indiscriminate use of NAg could further promote the development of silver resistance in bacteria. The bacterium ‘Acinetobacter baumannii’ (a bacterial pathogen) was recently listed as the "number one" critical level priority pathogen because of the significant rise of antibiotic resistance in this species 52 . Currently, NAg still has proven bactericidal activity towards this bacterium (A. Baumannii) even against strains that display multi-drug resistance. Therefore, it is of utmost importance to avoid silver resistance developing in this bacterium also in the light of scientific reports on heavy metal-driven co-selection of antibiotic resistance. Consequently, the widespread use of NAg in commercially available products promotes a prolonged microorganism exposure to bioavailable silver, which enhances the advance of multi resistant bacteria / micro-organisms.

Finally, NAg and its transformed products are toxic to environmental microbes. Microbial and gene abundance shifts are observed in various environmental settings. Physical and chemical transformations of NAg can shift the diversity and abundance of microbes, including those that are important in nitrogen cycles and decomposition of organic matters. The combined ecological impacts of NAg call for a prudent use of silver and AgNPs and minimising their water related emissions  53 .

Source control could include pre-treatment or onsite waste water treatment by reverse osmosis (RO) prior to direct discharges or releases to sewer, amounting to an estimated cost of 0.1% of the industry’s annual turnover 54 . Alternatively, urban waste water treatment plants would need to invest in reverse osmosis to clean such effluents. Assuming that between 1-5% UWWTPs would have to deploy reverse osmosis, costs for EU taxpayers would be between €2,184,600 and €109,230,000. Assuming the benefits of reducing silver related AMR to equal between 50% to 100% of the AMR costs for antibiotics, this results in EU-benefits of between €22 to €63 billion 55 (2014 data, subsequently corrected for inflation between 2014 and 2021).

Pathway disruption measures consist of capturing and treating of mine drainage water before it reaches water bodies. A targeted plan of action to tackle emission might be needed on a MS by MS basis.

As detailed in Annex 9, table A9.1, the social impact of listing additional substances mentioned in this paragraph concerns better protection of health in particular through addressing the health and environmental effects of nanosilver, including the role of silver in antimicrobial resistance, food security and ecosystem services such as avoided impact on pollinators.

6.2.26.2.2    Policy option 2 – listing candidate PS as a group

Under this policy option substances would be added under family groupings: PFAS 56 , estrogenic hormones, macrolide antibiotics, neonicotinoids and pyrethroids. This could limit the burden on MS as well as disincentivise substitution with another similarly hazardous substance in the same group. A group approach also helps better address overall cumulative risks of substances with similar toxicity and modes of action and can help capture degradation products of the substances with the same effects.

There are 9,000+ per- and polyfluoroalkyl substances (PFAS) in existence, which makes regulating PFAS individually infeasible. It is estimated that an EU PFAS ban in firefighting foams may cost society €390 million per year over a 30-year period (26). For surface water the major pathway is fire-fighting foams providing significant losses directly to the wastewater system. The environment of oil-drilling sites and airports (due to drills and exercises) is typically highly contaminated, with potential remediation costs of €0.6-2.5 billion for the 850 57 larger airports in Europe 58 or even €18.3 billion when all EU military and small airports 59 are included. Economic benefits from avoiding PFAS ending up in water include the potential for water reuse, including for irrigation purposes in line with the new Regulation on minimum requirements for water reuse. Benefits (avoided costs) of PFAS removal in waste water are considerable: at least €9.13 billion/year 60 . Moreover, PFAS removal processes create large additional amounts of waste (brine) – approximately 25% of treated water (76) requires separate treatment and subsequent re-mineralisation to create drinking water. Estimates of the avoided cost for reverse osmosis, specifically, to prepare drinking water amount to over €1/m³ equalling circa €200 per household per year (77), equalling avoid water treatment costs of 39.1 billion annually, if applied to all 195 million EU households. Also, not having to use RO to produce drinking water will result in 20% savings of water extraction volumes compared to a situation in which RO would be required. Total annual health-related costs, for three different levels of exposure, were found to be at least EUR 52 to EUR 84 billion in the EEA countries. Non-health-based costs environmental PFAS remediation totalling EUR 821 million to EUR 170 billion (EEA/EU), with plausible best estimate EUR 10–20 billion. In addition, measures at source would avoid costs of at least €39.4 million EU-wide related to a complete removal of PFAS from paper mills effluents and sludges.

Health costs of hormone disrupting chemicals, including estrogenic hormones, are estimated at €150 billion a year 61 . Studies also show strong toxicological evidence for male infertility attributable to EDC exposure, with a 40-69% probability of causing 618,000 additional assisted reproductive technology procedures, costing €4.71 billion annually (78) (79) (80). The effects of the exposure such endocrine disrupting substance (EDCs) have been linked to reproductive problems (e.g. with declining sperm counts), some cancers, impaired intelligence, obesity and diabetes, but also with effects on animals, with invertebrates being the most sensitive (81). Studies concluded an EDC causation for IQ loss and associated intellectual disability, attention-deficit hyperactivity disorder, childhood obesity, adult obesity, adult diabetes, cryptorchidism, male infertility, and mortality associated with reduced testosterone, e estimated to cost of €157 billion (corresponding to 1.23% of EU gross domestic product) annually (82). For macrolide antibiotics, measures across the life cycle of medication are required. As an example, many pharmaceuticals but also PFAS, can harm reproduction, reproductive success, and population health not only for aquatic species, but indirectly also for humans. Therefore, benefits are also expected for the aquaculture sector through avoided costs associated with losses of fish and shellfish populations in aquaculture farms. Some of the most affected species are trout (2019 EU production value €677 million), seabass (€491 million), crustaceans (€1.05 billion) and salmon (€1.34 billion) (83). Assuming that 5% -10% of the production value can be related to EDC exposure results in annual EU wide avoided costs ranging from €177 - €355 million.

Social impacts of the policy option assessed in this paragraph are, as mentioned in Annex 9, table A9.3, limited to more effective management of the substances when grouped as opposed to individual listing.

6.2.36.2.3    Policy option 3 – revising EQS for certain existing PS

The assessment finds that, for the substances concerned, the additional effort to be made by MS to reach the EQS will be small to relatively large (see Chapter 6.1.1 and Annex 4).

For cypermethrin, a combination of source control, substitution by less harmful alternatives, and end-of-pipe measures are likely needed as the substance is commonly used as pesticide and wood preserving chemical. Costs to remove cypermethrin in UWWTPs are estimated at €26.2 (per population equivalent, per year). PBDEs and Di-2-ethylhexyl phthalate (DEHP) and its compounds are associated with health effects such as cognitive deficits, (testicular) cancer and cryptorchidism as well as adult obesity, adult diabetes, and reproductive effects for females (endometriosis) (84). Mercury and its compounds and organophosphate pesticides are associated with cognitive deficits resulting from exposure (85).

For diuron and chlorpyrifos, market authorisations expired recently, meaning remaining stockpiles will be used up and exemptions (emergency authorisations) will drive emissions. Other topics relate to legacy issues resulting from the persistence of such substances. For diuron a possible remediation measure could be removing and replacing obsolete contaminated wood-based infrastructure. In some instances, the use of dredging may be appropriate for the removal of substances bound to the sediment in waterbodies, which can be relatively cheap or very costly, depending on the level of after treatment required.

The social impacts of this option are principally in greater human health protection from the chronic or bio accumulative nature of the pollutants concerned. Details can be found in Annex 9, table A9.4.

6.2.46.2.4    Policy option 4 – deselection of priority substances

These substances were identified to no longer pose an EU-wide risk to the environment and public health. Alachlor, Simazine and Chlorfenvinphos (herbicides) have banned in the EU for many years, and concentrations above the EQS are identified in a very limited number of water bodies (table A11.2). Therefore, the overall risk to the environment is considered to be low.

Use of Trichlorobenzenes (solvents and chemical intermediates) is ongoing, and the substances are acutely toxic to the aquatic environment. The rates of EQS exceedance are not very high, but deselection is more questionable than for the other substances given the degree of risk they post and their relevant for the MSFD.

Carbon tetrachloride is not recognised as a POP and the rates of EQS exceedances are low with declining trends, indicating localised issues and no EU-wide risk. Also, the ongoing use of this substance is directly or indirectly controlled and monitored under other policies like REACH, IED, the Regulation for the Classification and Labelling of Chemicals (CLP), therefore deselection from the PS list would not result in a negative environmental or societal impact.

All substances have in common that, even if they were removed from the PS list, they might still be relevant as RBSPs, and MS could decide to continue monitoring them at national level where needed. Deselection could free up resources that can be reallocated to emerging risks, e.g. due to saved monitoring costs (between €4 and €12 million annually at EU level).

Deselection as assessed in option 4 is not expected to have negative social impacts since the risk of exposure to the substances concerned is very low. A possible negative effect, in relation to trichlorobenzenes and carbon tetrachloride, may be that less monitoring would reduce the information base for deciding on reduction measures. Hence for these substances an approach at River Basin level should be considered.

6.36.3    Groundwater – impacts of policy options 

A key aspect of understanding the potential impact of the groundwater policy options is defining the “gap” between the baseline situation and meeting the proposed GW QS or likely national TVs set at MS level for pollutants listed in Annex II of the GWD. Subsequently this assessment was used as the basis for determining the types and potential level of uptake of measures needed to get to good chemical status, and how their implementation would impact stakeholders. Likely environmental, economic and social impacts were assessed, and various impacts of the options described (incl. the administrative burden on responsible authorities).

It needs to be noted however that the quality of the data for groundwater in Europe are, for several reasons 62 , of a lower quality compared to surface water. Consequently, the outcomes of the distance to target assessment and the comparison of the impacts of the policy options are subject to a higher level of uncertainty.

Measures to address PFAS, nrMs or pharmaceuticals can be remediation of soil or the groundwater (e.g. in case of polluted fire-fighting sites), source control (bans or restrictions on use, substitutes, guidance on proper use, avoiding production losses) and end-of-pipe/ pathway disruption (wastewater or landfill leachate treatment, incineration or landfilling).

Costs vary strongly depending on the type of measure. Examples can be found in Annex 10.

6.3.16.3.1    Policy option 1 – listing LFR substances individually or as group of specific chemicals in GWD Annex I

PFAS

The main additional expense for most MS will be the costs of laboratory analysis, and in particular Option 1 (a group of 24 PFAS in Annex I and assigned a GW QS of 4.4 ng/l PFOA equivalent), where a “sum of” methodology or very low concentrations need to be analysed and are likely to require more effort, and 2 (all PFAS in Annex I with a GW QS for “PFAS total” of 0.5 µg/l). The measures likely to be used by MS are similar for all options (aside from Option 3).

A cheap source measure to reduce future emissions of one of the 24 specific PFAS would be to use other PFAS substitutes not used yet. This would however potentially trigger new legacy issues in the future because of PFAS persistence. For the regulated PFAS (PFOS, PFOA, PFHxS, PFHxA and the C9-C14 carboxylic acids) stringent measures that restrict emissions are already in place; it is likely that, for the remaining group of 10 substances, which overlap with the DWD substances and the EQSD proposed substances, further controls should be instigated at the EU level with cost to industry.

Pathway disruption measures like the capture of contaminated sludge, containing and incineration are very costly due the energy intensiveness, so these measures are suitable only in extreme circumstances. Guidance on the best practise use of waste and wastewater by-products in agriculture would be a cheaper option. However, this will ultimately result in PFAS accumulating in agricultural soils. Instead of using pathway disruption measures, it is more likely that for Options 1 and 2 actions to restrict use of PFAS and better management of waste streams are used, as well as groundwater or soil remediation.

Pharmaceuticals

As regards Option 1 (adding Carbamazepine and Sulfamethoxazole to Annex I), this would likely lead to some administrative burden on those MS which do not yet monitor these substances. A worst-case estimate is €2 million per year at EU level.

nrMs

The costs of adding nrMs to the monitoring networks are likely to be limited, since the existing framework for assessing risk to groundwater from ‘parent’ pesticides and their relevant metabolites are already in place. A small increase in costs is likely for Option 1 (adding all nrMs to Annex I as individual substances with a GW QS of 0.1 µg/l), since it requires, at least for those countries which are not already doing this, that “all nrMs” are included in the analysis.

The implementation of the EU Farm to Fork Strategy will likely lead to reductions in the use of any permitted parent pesticides of the nrMs considered. This will be delivered in part through the planned revision of the Directive on the Sustainable Use of Pesticides and national action plans for pesticide use reduction. This will limit what additional measures need to be taken to protect their water bodies. By including all nrMs in Annex I under Options 1 and 2, the administrative burden may be progressively reduced further as the legislation would be “future proofed”.

Environmental benefits are rather similar for all the nrM options but options covering all nrMs and setting a GW QS at EU level (i.e. Option 1 and 2) are expected to generate greater benefits. Benefits include reduction and possibly reversal of impacts on groundwater biota, benefits for ecosystems services provided by the groundwater and linked surface water, increased quality process water from groundwater / surface water for drinking water, agriculture and industry.

6.3.26.3.2    Policy option 2 – listing LFR substances as groups of substances in GWD Annex I

By grouping similar pollutants, with a GW QS for the total group, legislation can deal with large substance groups with rapidly changing information on the impacts which would, in a sense, “future proof” legislation.

PFAS

The main additional expense under Option 2 (all PFAS in Annex I with a GW QS for “PFAS total” of 0.5 µg/l) for most MS will be the costs of laboratory analysis.

Pharmaceuticals

The main administrative benefit of Option 2 (adding all pharmaceuticals as a group to Annex I) is that it “future proofs” the listing by including substances which may become problematic in future and stimulates the modernisation of analytical techniques. The latter would result in considerable cost savings as soon as modern techniques have become more commonplace. Under Option 2b direct analytical costs will be around €5.5 million per year, with potential administrative costs taking this up to a total of €11 million per year. For Option 2c (adding all pharmaceuticals as a group to Annex II for MS to consider setting a TV), the analytical costs will vary between MS depending on the TVs adopted and the monitoring strategy used, but the impact on administrative burden to MS would be smaller.

Estimated costs of measures for Option 2 are shown in Annex 10. Many of these are considered cost-effective and acceptable for society. The main environmental costs of adding pharmaceuticals to the GWD would be implementation of measures to deal with wastewater /biosolids containing pharmaceuticals which can be energy intensive and require the use of chemicals. The incineration /landfilling of biosolids is suggested as a last resort measure as there is currently no viable treatment to remove pharmaceuticals from these media.

Environmental benefits of adding substances largely consist of lower risk of (irreversible) damage to natural ecosystems. These benefits are greatest under Option 2, due to the wider range of pharmaceuticals addressed.

Under Option 2 the understanding of the impact of pharmaceuticals on groundwaters is most pronounced. Also, the aim of the Pharmaceuticals Strategy to reduce the level of anti-microbial resistance is best supported by this option.

nrMs

The costs of adding nrMs to the monitoring networks are likely to be limited, since the existing framework for assessing risk to groundwater from ‘parent’ pesticides and their relevant metabolites are already in place. A small increase in costs is likely for Option 2 (adding all nrMs to Annex I with a group GW QS of 10 µg/l), since it requires, at least for those countries which are not already doing this, that “all nrMs” are included in the analysis.

Environmental benefits are rather similar for all the nrM options but options covering all nrMs and setting a GW QS at EU level (i.e. Option 1 and 2) are expected to generate greater benefits. Benefits include reduction and possibly reversal of impacts on groundwater biota, benefits for ecosystems services provided by the groundwater and linked surface water, increased quality process water from groundwater / surface water for drinking water, agriculture and industry.

6.3.36.3.3    Policy option 3 – listing LFR substances in GWD Annex II

PFAS

Option 3 for PFAS would lead to TVs being set by individual MS using drinking water standards and likely focusing on point source pollution rather than on diffuse pollution. The most likely measures to deal with pollution point sources could be to initiate soil remediation measures, e.g. for pollution hotspots like firefighting sites. This option would moreover lead to diverging national TVs and thus be detrimental to the objective under Art. 7 WFD to setting uniform EU quality standards for groundwater. Setting a uniform GW TV at EU level would, on the contrary, lead to savings in treatment costs.

Costs for all PFAS inclusion in Annex II for MS to consider setting a TV (Option 3) will be the lowest, given the DWD requirements and additional data collated. This is especially the case for the MS which are already monitoring PFAS and carrying out risk assessments for groundwater.

Pharmaceuticals

Option 3 will have significantly less environmental benefits compared to Options 1 and 2 and distortion of the ‘level playing field’.

nrMs

The costs of adding nrMs to the monitoring networks are likely to be limited, since the existing framework for assessing risk to groundwater from ‘parent’ pesticides and their relevant metabolites are already in place. The administrative burden of Option 3 (adding all nrMs to Annex II for MS to consider setting a TV) will be smaller at EU level but higher at MS level, because of the need to set TVs at national level.

Additional measures that could be considered by MS would mainly focus on the amenity /legacy pollution including substitution through less harmful substances, remediation of existing / historical sources and use of other weed control methods for amenity use.

If measures taken by MS to reduce nrMs in groundwater would include source control such as restrictions on use this would have an impact on the farming sector and possibly also on crop yields. Estimated costs of using substitution products are shown in Annex 10: it should be in particular stressed that less toxic alternatives do exists for at least the five permitted parent pesticides, with similar cost ranges.

For Option 3 (TV set at MS level) greater variance in environmental benefits is expected between MS. Benefits include reduction and possibly reversal of impacts on groundwater biota, benefits for ecosystems services provided by the groundwater and linked surface water, increased quality process water from groundwater / surface water for drinking water, agriculture and industry.

As specified in tables A9.7 through A9.9 social impacts are mostly related to better protection of health due to lower exposure to substances, in particular from the PFAS group and pesticides. Indirect social benefits are generated through improved ecosystem services (better protected water sources, recreation, less polluted fish etc). Possible negative effects include lower yields increased costs in farming or higher costs, as well, in relation to antibiotics, a limited reduction of choice in available antibiotics options.

Impacts on SMEs under the groundwater options follow the same pattern as under the surface water options.

6.46.4    Monitoring, reporting and administrative streamlining – impacts of options

The impacts of all policy options related to monitoring, reporting and administrative streamlining are described below. Clear synergies exist between this initiative, the Zero Pollution Outlook, and the Commission proposal for a Regulation of the Industrial Emissions Portal (IEPR, former E-PRTR), the EU Strategy for Data, the INSPIRE Directive, and the Directive on Public Access to Environmental Information. In particular, data collected under policy options 3, 4, 6 and 7 would lead to better water quality data in shorter than the current 6-years intervals. This water related data could complement and be cross referenced with publicly available data on emissions from industrial installations covered by the IEPR and help monitor the effects of the implementation of new Best Available Techniques on the aquatic environment surrounding such installations. Vice versa, an improved digital data collection on geographical and seasonal pesticides use under the envisaged revised Sustainable Use of Pesticides Regulation, would be highly valuable input for an improved implementation of legislation like the WFD and the EQSDs, as well as the EU Biodiversity Strategy 2020, the common agricultural policy (CAP), and the Thematic Strategy on Soils. Finally, for practically all of (sub)options, related to digitalisation, improved monitoring etc., existing EU research projects funded through FP7, H2020 and Horizon Europe can support a further practical development, and outcomes of past and ongoing Research & Innovation (R&I) projects could consequently also help reduce costs of an increased digitalisation .

6.4.16.4.1    Policy option 1 – Guidance and advice on monitoring

Sub-option (a): Develop guidelines on applying innovative methods in monitoring procedures, including continuous / automated monitoring techniques

The impacts of Sub-option 1a are limited since it would summarise best practise examples and use those to detail how approaches can be implemented. The expected costs are limited, but the potential impacts and associated benefits for MS monitoring programmes can be significant if properly implemented and would lead towards harmonised monitoring and measurement approaches for contaminants of emerging concern. The costs for developing EU guidelines ranges from around €290,000 for simple guidance documents to around €500,000 for more elaborate documents (see Annex 10). Based on the assumption that around 1 or 2 guidance documents on innovative monitoring methods would be required, total EU costs range from €580,000 to €1 million.

Sub-option (b): Improve existing EBM guidelines to improve monitoring of groups/mixtures of pollutants by using EBMs, and define trigger values for assessing the status of a water body.

The impacts of Sub-option 1b involve the further development of guidelines on the types of effect-based methods, and deriving trigger values 63 for mixture pollutants to be applied in practise. Effect-based trigger (EBT) values establish the likelihood of adverse impacts on water quality and are used to differentiate good from poor water quality. EBT values for in vitro bioassays can be used to assess if a water body is in good or poor status based on the effects on the aquatic organisms. Also, by dividing bioanalytical responses by their respective EBT values, effect-based risk quotients can be obtained, which can then be summed per location to assess the cumulative ecotoxicological risks. Consequently, they are important for surface water quality monitoring while considering mixture toxicity, but of course in close alignment with EQSs for individual chemicals. Costs for the further development of EBM guidelines are comparable to those of a simple guidance document and are estimated at €290,000.

Sub-option (c): Develop a harmonised measurement and monitoring method and guidance for microplastics in surface water and groundwater, as a basis for MS reporting on microplastics and a future listing under EQSD and GWD.

Overall cost to society of microplastics is estimated between €10.8 to €19.1 billion (36) (86). One major microplastics category the EU intends to address (others are textiles, pellets, paints, geotextiles, detergents capsules) is tyres. A recent revision of the Tyre Approval Regulation has removed the worst performing tyres from the market (87) while EU labelling of tyres according to their abrasion rates is a strong incentive to push the market to the best performing tyres amongst those left on the market. Physical barriers to avoid microplastics ending up in surface waters would be effective measures as well (so called gully pots to capture particles or microplastic filters in washing machines (88) as foreseen in the EU microplastics initiative. End-of-pipe treatments for microplastics could be effective too, at a cost between €0.08-0.20 per cubic metre of wastewater treated per year (see upcoming UWWTD revision, whereby the application of tertiary level treatment in WWT plants is being proposed for larger agglomerations at risk). This treatment will trigger knock-on problems with the plastic-contaminated sludge, which are being assessed in the ongoing Evaluation of the SSD

The impacts of Sub-option 1c involve the costs of development of a harmonised measurement standard and guidelines for monitoring. As a relatively unchartered territory, initial costs may be higher than for traditional chemical substances or groups of substances. Based on expert judgement from the JRC related to developing a harmonised measurement and monitoring method for microplastics in drinking water, and information from EU funded projects supporting the EU Plastic Strategy 64 , the development of a harmonised measurement and monitoring methodology for microplastics and the accompanying guidance is estimated to cost between €290,000 to €500,000 65 . Once the method is developed, the annual EU costs for measuring and monitoring microplastics are estimated to range from €7.3 to €13.4 million 66 .

A harmonised measurement and monitoring method for microplastics is a vital prerequisite for monitoring by MS and future development of policies to reduce emissions to surface water, groundwater and coastal waters. Mandatory monitoring according to a harmonised methodology will provide a wealth of monitoring data on types and quantities of microplastics occurring in surface water, groundwater and coast waters. Firstly, this is paramount for improving the current limited understanding of the environmental fate and behaviour of microplastics. Secondly, this supports follow-up studies like the Bleu2 study (89), and allows developing and validating future simulation models (no microplastics simulation model was found in the EC Modelling Inventory (MIDAS)). Finally, obtained monitoring results could facilitate the assessment of effectiveness of other EU policies dealing with microplastics (e.g. the upcoming initiatives on controlling unintentional releases).

Sub-option (d): Develop guidelines on sampling frequency for PSs and RBSPs.

Sub-option 1d involves the development of a guidance document for MS on best-practice sampling approaches for PSs and how to integrate such approaches into water-quality assessments and monitoring strategies. This sub-option will require limited administrative effort, particularly at EU level, while benefits relate to increased harmonisation of sampling frequencies across the EU, and therefore greater comparability of data between countries and river basins, allowing for more targeted policy interventions. Costs to develop these guidelines are expected to be between €290,000 to around €500,000 (Annex 10). The Fitness Check of EU environmental reporting and monitoring acquis (10) estimated the approximate annual administrative burden related to reporting to MS for the EQSD to be moderate (i.e. within the range of €30,000 and €100,000 per MS). The estimated additional costs of aligning sampling frequencies to the developed guidance is expected not to exceed more than 5-10% of those costs.

Sub-option (e): Provide a repository for sharing best practices from MS regarding available monitoring techniques, and foster cooperation to implement these.

Option 4 foresees the development of an online repository of standards and best-practice approaches to improving MS monitoring techniques. This would build upon and complement option 1, providing a living, online location to allow consistent updates on monitoring techniques and providing a forum for actors to facilitate knowledge transfer. This option will require a limited administrative effort, particularly at EU level. Cost of developing and hosting a simple repository of best practices is similar to those for drafting guidance documents and ranges from €290,000 to €500,000 (Annex 10, Table A10.5).

6.4.26.4.2    Policy option 2 – Obligatory monitoring practices

Sub-option (a): Include an obligation in the EQSD to use EBMs to monitor estrogens.

Option 2a involves the mandatory use of EBMs to monitor estrogens in practice (90). Commercially available bioassays (e.g. ER-CALUX, A-YES and others) are important tools for assessing the toxicity of water samples (91). License-free versions of this type of assay are commercially available and are covered by international inter-laboratory trials. ISO 19040-3 defines validity criteria covering further cell-line-based reporter gene assays. Also, sample preparations do not require special treatment, and extraction / concentration methods are based Solid Phase Extraction (also used for analytical methods) which is very cheap. If performed in-house, costs of around €60/sample (incl. costs for personnel and consumables) are possible. If using commercial labs, costs are around €60-200 euros per sample. Standard Operating Procedures (SOPs) for this type of in vitro EBMs are available and three assays are even ISO standardised. Standardisation has already driven down costs, but future further validation and inter-laboratory studies for other bioassays, used to evaluate effects from estrogenic compounds, would provide a wider choice of methods and result in a further decrease of costs in the coming years. EBM related costs can also be reduced by reusing outcomes of FP7 funded research projects like ‘Solutions’. Solutions already developed chemical, effect‐based and ecological tools for monitoring and assessing the presence and effects of mixtures including contaminants of emerging concern (92).

Sub-option (b): Establish an obligatory Groundwater Watch List mechanism analogous to that for surface waters and drinking water, and provide guidance as necessary on the monitoring of the listed substances.

Impacts of this sub-option are comparable to those of the existing SW WL and consist of annual sampling and analysing, by MS, of a limited number of substances. The information gathered would be collected and analysed at EU level, at an approximate annual cost below €1 million. The administrative cost at MS level are comparable to those of the EQSD (see option 1 sub-option d), i.e. between €30,000 and €100,000 per MS per year. The benefit, compared to the existing voluntary watch list, is in achieving a much-improved data set, allowing more targeted and effective policy interventions at both EU and national level.

Sub-option (c): Improve the monitoring and review cycle of the Surface Water Watch List so that there is more time to process the data before revising the list.

The sub-option would require, for some substances, an increased frequency of sampling/analysis for monitoring, which would however be compensated by an extension of the watch list review cycle from 2 to 3 years. Therefore, it is expected that the cost impact will be neutral. The major benefit is in capturing substances that have strong seasonal fluctuations, rendering the watch list results more accurate.

6.4.36.4.3    Policy option 3 – Reporting and classification

Sub-option (a): Establish an automated data delivery mechanism for the EQSD and the WFD.

Currently, the minimum frequency of monitoring of priority substances in surface water is once per month. However, the aggregated data are only reported every six years. The benefits of sub-option 3a are in obtaining more frequent accessibility of monitoring and status data, allowing to show to the public and policy makers at EU and MS level intermediate progress. It is expected that this will require a significant administrative effort both at EU and MS level. On the EEA side, the costs of facilitating an increased "digitalisation" to accommodate this option will require additional staff at EEA plus EUR 50-100K / year for IT consultancy and hardware. Preparedness for an automated data delivery mechanism varies across MS authorities. While MS maintain their own data sources, data is not usually aligned in terms of spatial coverage and temporal trends and thus requires harmonisation. Also, the system of ‘pass /fail’ does not provide much insight in the magnitude of exceedances and thus hampers focusing policy responses on pollution hotspots. If concentration data would be reported, this would yield valuable information to investigate the nexus between better water quality and improved human health by using data from the water quality monitoring and evaluation. Expected efforts needed to streamline reporting will, in the long-term, be compensated by reduced administrative burdens, with costs also likely to reduce in the medium to long term. In addition, through digitalisation and automated data reporting, MS data and metadata can be more easily and more frequently accessed and compared, and made available via an online, centralised platform, making them more transparent and up to date. This intervention is coherent with the Zero Pollution Monitoring and Outlook as it improves the basis for better Water Pollution Outlooks reports and introduces co-benefits for the ‘1-substance-1-assessment’ work by ECHA.

The harmonised digital automated data delivery will simplify reporting on inventory of emissions and increase links with the revised Industrial Emissions Portal. This is beneficial for the obligation for MS, according to Article 5 of the EQSD, to establish an inventory of emissions, discharges and losses of all PS and pollutants listed in Part A of Annex I the Directive. This is also coherent with the recent Commission proposal establishing an Industrial Emissions Portal (93), as it can improve the exchange of data between the EU European Pollutant Release and Transfer Register (E-PRTR) and the inventories of industrial emissions. This will enhance the implementation and policy making (including at EU level) through more transparent and real time data enabling focussed decision making and effective control. This would also be beneficial for an increased compliance by MS with the provisions of the EU INSPIRE, and Access to Environmental Information Directives. It also increases coherence with the proposed EU Data Act (94). Whilst there may be an initial administrative burden resulting from the instalment of interoperable data sets which can be accessed by the EC and the relevant EU Agencies, considerable gains, including a reduced administrative burden for MS, are expected in the medium and long run.

Sub-option (b): Introduce a reference list (repository of standards) of environmental quality standards (EQS) for RBSPs as an annex to the EQSD, and incorporate RBSPs into the assessment of chemical status for surface waters.

Creating a repository assists MS in deriving national EQS, in turn allowing EU standards to be developed and included in the repository following adoption by comitology. This aligns to a proposal under the Chemicals Strategy, which envisages the development of a wider repository of all EU standards for chemical substances. EQS data could feed directly into that work. A harmonised repository would lower the overall administrative burden.

A common repository of standards would secure that knowledge stays accessible to MS and stakeholders. According to EEA data, MS have reported around 150 RBSPs under the 2nd RBMPs. This data would be transferred to the EEA / JRC in a one-off migration to the newly created EU repository. This facilitates quality assurance and measures for RBSPs at River Basin Districts (RBDs) level. One-off costs for developing a repository of standards are comparable to those for developing guidance (€290,000 to €500,000). For hosting and maintenance 0.5 FTE plus EUR 10-20K / year for IT consultancy/hardware are required.

The second part of this option aims at ensuring that, when assessing the chemical status, the results of the RBSPs assessment are included in the assessment of the overall chemical status of a SWB (currently the results are assessed as part of the ecological status assessment). This will improve the consistency within the WFD. This is a relatively significant change for MS and stakeholders and would result in a one-off alignment of reporting systems. Benefits would consist of removing the bias in the status of a SWB since it would be based on harmonised EQSD for RBSPs as currently some MS might have implemented too strict or too lax standards for their RBSPs. Another expected side-effect is that the number of WBs in good ecological status would increase, since possible exceedances due to RSBPs have less effects on achieving good chemical status as they are generally in worse status.

6.4.46.4.4    Policy option 4 – Legislative and administrative aspects

Sub-option (a): Use an annex in the EQSD instead of Annex X to the WFD to define the list of PS, and update the lists of SW and GW substances by Comitology or delegated acts.

This option would allow for a significant acceleration of the time required to update the lists of substances under the EQSD and the GWD. The main impact in administrative terms is on EU Institutions, which would be called to act via delegated acts rather than through the ordinary legislative procedure. In environmental and public health terms, it will allow a swifter policy reaction to emerging pollutants, and a faster delisting if pollutants are no longer a threat, in line with the latest scientific progress and knowledge. Administrative costs will be lower at EU level while at Member State level no significant impact is expected.

Sub-option (b): Change the status of the ‘eight other pollutants’ added to the EQSD from the former Dangerous Substances Directive (76/464/EEC) to that of PS/PHS.

The eight pollutants concerned (pesticides Aldrin, Dieldrin, Endrin, Isodrin, DDT, and industrial chemicals Tetrachloroethylene, Trichloroethylene, Carbon tetrachloride) are listed in Annex I of the EQSD and have EQSs derived, but it is stated in footnote 7 of the Annex that these substances are not Priority Substances. This creates confusion with WFD Article 16.7. Their existing EQS monitoring feeds into surface water chemical status assessment. The results of the assessment show that seven out of eight substances either a) are covered by Regulation (EU) 2019/1021 on persistent organic pollutants (the POPs Regulation) obliging MS to put into place and maintain inventories for such substances; b) show EQS value exceedances in freshwater (no declining emission trends); or c) are covered by the DWD. Therefore, these substances should be recognised as PS to avoid incoherencies with other EU legislation. Specifically, this concerns the cyclodiene pesticides (Aldrin, Dieldrin, Endrin and Isodrin), DDT, Tetrachloroethylene and Trichloroethylene. Marking them as PS will create greater policy coherence, help track their presence in water and inform subsequent risk assessments. Formally assigning them PS status is merely administrative and entails no costs.

Furthermore, it is not clear why some of these substances have not been designated as PHS 67 under Annex II of the EQSD. Aldrin, Dieldrin, Endrin, Isodrin, DDT are POPs and Trichloroethylene is SVHC, hence fulfilling the criteria for PHS status. The result of that is that most of them (all except of carbon tetrachloride) are Persistent Organic Pollutants (POPs) or should be marked as priority hazardous substances for other legislative or toxicological reasons.

Consequently, with the exception of carbon tetrachloride which is proposed for deselection (see SW option 4), all substances should be formally recognised as PS under EQSD Annex I and some also as PHS under Annex II. Assigning PS/PHS status is merely an administrative change without further negative impacts, but formalisation is preferred to continue their monitoring.

Sub-option (c): Change the status of some existing PS to that of PHS where it fulfils the criteria of the POP Regulation and/or Article 57 of REACH Regulation.

Since the last EQSD revision in 2013, five existing priority substances have been identified as PHS:

·1,2-Dichloroethane is classed as SVHC under Article 57 of REACH Regulation.

·Fluoranthene PBT vPvB and is classed as SVHC under Article 57 of REACH Regulation

·Lead is classed as SVHC under Article 57 of REACH Regulation

·Octylphenol ethoxylates (OPEs) are toxic to aquatic organisms even at low concentrations and show edocrine disrupting properties. They break down easily to octylphenols which are more harmful, not readily biodegradable and meet the criteria for persistence or high persistence in the environment. Consequently, OPEs are considered as SVHC requiring authorisation for specific use in the EU according to Annex XIV of the REACH Regulation.

·Pentachlorophenol (PCP) is covered by the POPs Regulation.

6.56.5    Administrative burden 

As indicated in Chapter 6.4 the approximate annual administrative burden related to reporting ranges from €30,000 to €100,000 per MS. The impact assessment estimated the additional monitoring costs as €15-36 million per year for the whole EU. Costs of €2-4 million per year for the EU were estimated for a database and the costs to develop technical specifications for monitoring were estimated at <€0.2 million per year for the whole EU (10). However, the Fitness Check on the EU environmental reporting and monitoring acquis also concluded that the benefits of reporting obligations significantly exceed the costs, as without reporting obligations the Commission cannot verify a correct implementation. This is even more pertinent in light of the revamped impulse provided by the European Green Deal and the co-legislators’ agreement to put in place an encompassing Environmental Monitoring Framework under the 8th Environmental Action Programme (95). In particular, the outputs from this policy intervention would feed into the Zero Pollution Monitoring and Outlook Framework announced by the ZPAP.

The costs related to putting in place an obligatory monitoring method for microplastics are calculated to range from €7,298,800 to €13,362,700.

The administrative burden associated to the groundwater options is limited. For nrMs and pharmaceuticals, these range between €2 and 11 million depending on the level of ambition, with no significant additional administrative costs for risk /status assessments of substances. For PFAS the EU costs are higher, and estimated between €15 and 48 million, depending on the level of ambition, with no significant additional administrative costs for risk /status assessments of substances. All options benefit from the focus on PFAS in the recast DWD, triggering more attention for monitoring relevant substances in source water.

In the implementation of the WFD, EQSD and GWD, the Commission intends to concentrate all work related to the identification and prioritisation of pollutants, including their risk assessment, for inclusion in future revisions of the legislation and in the watchlists for surface water and groundwater, at ECHA. This will require reinforcement of the staff table of ECHA, though it should be noted that at the same time there will be some reductions in administrative expenses in the Commission.

6.66.6    Note on impacts for individual MS 

The differences in impacts across MS will vary depending on national measures already in place and/or newly proposed and the extent of pressure-exerting activities (agriculture, industry). For pharmaceuticals, for example, many MS already have compulsory or voluntary return programmes in place (Belgium, Czech Republic, Denmark, France Greece, Italy, Netherlands, Spain, Sweden), and/or launched environmental classification schemes for pharmaceuticals (Finland) and/or started other Green Pharmacy initiatives (Finland, Netherlands, Portugal, Sweden) and/or participate in EU funded projects in this area (the EU #Medsdisposal campaign 68 and the EU project "Priorisation and Risk Evaluation of Medicines in the Environment" 69 ). The best practice paper on Green and Sustainable Pharmacy in Europe 70 lists these as examples. In the abovementioned MS the potential impacts of proposed quality standards for pharmaceuticals will likely be less, than in MS who have not taken these (or other equivalent) measures.

The impacts also vary depending on the distance to target. As explained in section 6.1.1, it was not possible to conduct this assessment for each Member State, hence the distance to target indicates the situation at EU level. However, it can be considered that in MS and river basin districts where the water already (mostly) meets the proposed standards, the impacts will be less than in MS and river basin districts where the distance to target is still (relatively) large. Generally, areas of intensive agriculture and pesticide use (DE, FR, ES and IT account for 2/3 of sales of pesticides in the EU), those where domestic wastewater is not centrally collected and therefore less connected to treatment networks (e.g. areas with low population densities), as well as areas where the legislation on UWWT is not complied with (e.g. BG and RO and parts of IT, ES, PT), and water bodies with a limited flow (i.e. less dissolution of pollutants) would see the highest impact.

In summary, the EU water legislation does not specify exact measures to be taken to reach a given water quality standard, meaning that the respective efforts required by MS are largely dependent on the current status of pollution and individual choices (beyond what is required under EU legislation) of MS to address the situation with country specific measures.

77    How do the options compare and what are the preferred options? 

The comparison, where relevant, and evaluation of proposed surface and groundwater policy options is structured around the pollutants being assessed, i.e. the following:

·Pollutants considered for addition to the Priority Substance list (surface water options 1 and 2);

·Pollutants considered for existing EQS amendment (surface water option 3);

·Pollutants considered for deselection from the Priority Substance list (surface water option 4);

·Pollutants considered for addition to the GWD Annexes I and II (groundwater options 1, 2 and 3);

The evaluation of proposed monitoring, reporting and administrative streamlining options is structured around the policy elements being assessed, i.e. the following:

·Policy elements addressing monitoring guidelines;

·Policy elements addressing obligatory monitoring practices;

·Policy elements addressing reporting and classification;

·Policy elements addressing legislative and administrative aspects.

The assessment is presented below, with tables summarising the overall magnitude of impacts (considering the economic, environmental, and societal costs and benefits set out in Chapter 6, Annexes 3 and 9).

In addition, the efficiency, effectiveness and coherence of each of the policy options has been assessed and the results are summarised in throughout the tables in this section.

Quantitative and qualitative factors were considered in assigning the rankings for each criterion. The scale outlined below shows how "+" and "-" are attributed to positive and negative impact expectations.

The multi-criteria evaluation made of impacts, effectiveness, efficiency and coherence of the policy options provides support for the preferred policy package.

7.17.1    Surface water

The substances in the surface water options were grouped into three different categories. A first category in which the benefits of adding candidate substances to the PS list clearly outweigh the costs (with a sub-category for micro and nanoplastics). A second category where the costs and benefits are more balanced (in these cases a clear set of benefits have been identified, meaning that adding them is worthwhile, but there is a closer balance between the costs and benefits). For the third category, the costs outweigh the benefits.

7.1.17.1.1    Pollutants considered for addition to the PS list

The individual (SW option 1) and group (SW option 2) additions of candidate priority substances were compared, where possible, and the preferred option selected for relevant substances. More detailed information about the comparison of environmental, economic and social impacts of these options can be found in Annex 9.

Benefits clearly outweigh the costs for: industrial chemicals - PFAS (all 24 named substances plus the total of all PFAS) (96); pesticides (Glyphosate, Triclosan); neonicotinoid pesticides (Acetamiprid, Imidacloprid, Thiacloprid, Thiamethoxam); pyrethroid pesticides (Deltamethrin, Permethrin, Bifenthrin, Esfenvalerate); pharmaceuticals (Carbamazepine, Diclofenac); macrolide antibiotics (Azithromycin, Clarithromycin; Erythromycin); estrogenic hormones (17-Alpha-Ethinyl estradiol (EE2), 17-Beta estradiol (E2), Estrone (E1)).

As detailed in Annex 9, benefits largely relate to avoided healthcare costs stemming from an expected reduced exposure to harmful substances – to be noted this is exposure through all environmental media, not only groundwater or surface water. Specifically, for PFAS, the avoided health costs thanks to reduced exposure (via consumer products, background levels) a result of all EU and Member States policies addressing PFAS – therefore not only those linked to this initiative – are estimated at €52-84 billion/year. According to the Centre for Disease Control and Prevention (CDC), antimicrobial resistance adds a 20-billion-dollar surplus in direct healthcare costs in the United States, which is exclusive of about 35 billion dollars in loss of productivity annually. Numbers for the EU are comparable. The threat of antimicrobial resistance is of particular importance in the category of antibiotic resistance in bacteria. The European Union has an annual mortality rate of 27,000 attributable to AMR. This is comparable to the United States where 2 million people are affected every year by AMR and about 23,000 die as a result 71 . Worldwide, 700.000 people die annually from resistant infections and this means that if no action is taken, the estimated annual deaths attributable to AMR will be 10 million by 2050 (a 14-fold increase). Water can be a reservoir of bacteria resistant to pharmaceuticals due to the presence of pharmaceuticals as pressure, and/or bacteria that are co-resistant to both antibiotics and silver (bacteria share the same mechanism of the resistance). OECD analyses from 2018 found that investing just EUR 1.5 per capita per year in a policy package to tackle AMR is effective and cost-saving, avoiding 27 000 deaths and saving around EUR 1.5 billion each year in EU/EEA countries 72 . Without action AMR related costs will likely also increase 14-fold by 2050 which could then result in annual AMR related costs of around 21 billion by 2050. The EU benefits from an enhanced protection against the development of AMR is estimated at around €1.5 billion/year based on healthcare costs and productivity losses (relevant e.g. for the substances Azithromycin; Clarithromycin; Erythromycin). The annual benefits from a reduced exposure to endocrine disruptors are estimated at €163 billion. This is due to the fact that endocrine disruptors in Europe contribute substantially to neurobehavioral deficits and diseases, as well as to childhood obesity, costing costs €1.54 billion annually.

Avoided/reduced impacts on pollinators and agriculture (Acetamiprid, Clothianidin, Imidacloprid, Thiacloprid, Thiamethoxam, Bifenthrin, Deltamethrin Esfenvalerate, Permethrin) account for approximately €14.6 billion annually. Costs for packages of measures such as source control, pathway disruption and end-of-pipe are significant, but they tend to be lower after initial investment or one-off costs, while health and environmental benefits are recurring. Examples of costs are pathway disruption for glyphosate (buffer strips), estimated at around €285 million. Additional controls and treatment for farmed animal use of deltamethrin could cost around €185 million.

The following substances have “balanced” impacts: Ibuprofen, Nicosulfuron, Clothianidin, Bisphenol A, and Silver and are suggested for inclusion.

For silver, costs of listing are expected to be high but comparable to the benefits. This is in particular related to its role in avoiding antimicrobial resistance of bacteria (see also pharmaceuticals sections related to AMR). Water can be a reservoir of bacteria resistant to the silver due to the presence of silver as pressure, and/or bacteria that are co-resistant to both antibiotics and silver (bacteria share the same mechanism of the resistance). Since silver has antimicrobial effects comparable to pharmaceuticals similar costs are assumed to occur for silver 73  (around €1.5 billion/year based on healthcare costs and productivity losses). Similar to pharmaceuticals, without action AMR related costs will likely increase also increase 14-fold by 2050, resulting in annual AMR related costs of around 21 billion by 2050. Therefore, this substance is also suggested for inclusion on the PS list. 

These benefits and costs apply do not arise exclusively from this initiative, but would be the result of joint EU and Member State action, based on all policy instruments that address these pesticides and antimicrobials.

Table 7.1.1: Pollutants considered for addition to the Priority Substance list – preferred option

As indicated in Chapter 6, there are various reasons to use grouping approaches when adding substances to the priority substance list.

The assessment shows that, out of the four possible groups identified under this option (noting that the addition of PFAS as a group has already been included as part of Option 1) only for the macrolide antibiotics benefits outweigh the costs. Adding these substances as a group would ensure greater coherence in the approach to AMR. Also, correlations in use, pathways to environment and measures will result in significant cost savings if managed as a group. If grouped, possible measures by MS would likely be based on the EQS for Azithromycin as is expected to show the biggest distance to target.

A grouping approach is not recommended for estrogenic hormones, the neonicotinoid and pyrethroid pesticides.

For PFAS, the use of a relative potency factor (RPF 74 ) approach was considered for setting a group EQS but the scientific justification for that is still too uncertain to be introduced in the legislation. Consequently, a sum of all PFAS approach analogous to the DWD (see Annex 7 for more information) seems a more appropriate way forward.

7.1.27.1.2    Pollutants considered for existing EQS amendment

The assessment resulted in two categories of substances. A first category of substances for which the re-assessment of the threshold concluded that the benefits of an improved protection outweigh the costs, or where a less stringent threshold value has only limited impacts. For those an amendment of the EQS is preferable. The second category consists of substances for which the review and reappraisal of EQS concluded that additional measures may be warranted. In this case costs are higher but considered proportionate to the risks. For this category amendment is still considered preferable.

Table 7.1.2: Pollutants considered for existing EQS amendment – preferred option

For the following substances the benefits of an EQS amendment outweigh the costs: Dicofol; Diuron; Heptachlor/heptachlor epoxide; Hexachlorobenzene; Tributyltin; Dioxins and furans; Fluoranthene; Hexachlorobutadiene; Nonyl Phenol; PBDEs.

For the substances Chlorpyrifos; Cypermethrin; PAHs; Mercury and Nickel the impact assessment showed that the overall balance of costs and benefits will be neutral. This is because the revised EQS is significantly more stringent and thus yields benefits from increased protection (currently risks are underestimated and therefore additional effort is warranted) but could also trigger a need for new measures to help achieve the new EQS.

7.1.37.1.3    Pollutants considered for deselection from the Priority Substance list

Under this option two different categories are identified: 1) deselection would have more benefits than costs; 2) the costs and benefits are more balanced.

Table 7.1.3: Pollutants considered for deselection from the PS list – preferred option

The substances Alachlor, Simazine and Chlorfenvinphos (herbicides) are placed in the first category. They are banned in the EU for many years, and concentrations above the EQS are identified in only a limited number of water bodies. The overall risk to the environment is considered to be low. Deselection could free up resources that can be reallocated to emerging risks. The deselection of substances is likely to bring cost savings estimated at €3.8 m- €11.7 million per year.

Trichlorobenzenes (solvents and chemical intermediates) are placed in the second category. Their use is ongoing, and the substances are acutely toxic to the aquatic environment. The rates of exceedance are not very high, but deselection is more questionable than for the other substances given the risk quotient RQ and its MSFD relevance. To maintain protection, this substance could be monitored as a RBSP where needed. Consequently, trichlorobenzenes are not proposed for deselection.

All substances have in common that, even if they were removed from the PS list, they might still be relevant as RBSPs, and MS could decide to continue monitoring them at national level where needed.

7.27.2    Groundwater

Table 7.2.1: Pollutants for addition to GWD Annexes I and II – preferred option

Of all options, Option 3 (all PFAS in Annex II, TVs to be possibly set at MS level) not only provides the weakest protection of groundwater, but would also result in a fragmented approach per MS. Given the widespread pollution of PFAS in groundwater and the societal and environmental impacts, EU harmonised action is essential.

For Option 1 (group of 24 PFAS in Annex I) the distance to target is large, meaning that the concentrations in a large number of locations will likely exceed the proposed GW QS in a large number of MS. While the distance to target is similar for Option 2, a simple sum of all PFAS approach is suggested in order to future-proof the legislation. As the distance to target is similar, the types of implementing measures (requiring action on both point and diffuse pollution) would be similar for both options and costs and benefits would also be within the same ranges.

Option 2 are considered in line with the current DWD, but Option 2 would not “future proof” the legislation in terms of the remaining PFAS substances and is therefore not considered protective enough of public health. On this basis Option 1 is selected as the preferred option for PFAS. The latest EFSA opinion on the maximum tolerable intake also points in this direction.

The assessment, the SCHEER opinion and the results of the stakeholder consultation give a preference to Option 1 (add carbamazepine and sulfamethoxazole to Annex I, with individual GW QS). This option has generally smaller costs than Option 2 (adding the two substances as a group). Option 1 will lead to a reduced pollution of groundwater and positive impact on shellfish and fisheries where groundwater inputs to rivers and estuaries are of considerable importance. Product substitution is considered as a viable option for Sulfathemoxazole, but less for Carbamazepine. MS will likely not take measures such as the treatment of biosolids only for these two pharmaceuticals as that would be disproportionately expensive but rather turn to ‘Green Pharmacy’ 75 initiatives or other source control and pathway disruption measures.

The assessment also showed that there is enough evidence for Primidone 76 to be added to Annex II 77 (i.e. partly implementing Option 3), which would not have a large impact on costs or benefits. Adding Primidone means that MS have to establish suitable threshold values for this substance at national level.

Most of the parent pesticides of the 16 nrMs identified are already banned. For the remaining parent pesticides, a number of strategies and legislation at EU level will drive down pesticide use, as well as national action plans under the SUPD 78 . Stakeholder feedback suggests that there is a common understanding that nrMs are widely found in groundwater in worrying concentrations and that the emissions of the parent substances need to be limited.

The distance to target assessment suggests that options 3b (all nrMs as a group in Annex I) and 3c (all nrMs as a group in Annex II) are likely to maintain the status quo and no additional measures beyond those identified under the dynamic baseline scenario are needed. Option 3e (all nrMs in Annex I with lower GW QS) are coherent with that. Given that the 16 nrMs are already detected in groundwater, there is a risk of further substances detected in future at levels of concern. Option 3e extends the more stringent GW QS to all nrMs of pesticides and thus future proofs legislation, whilst following the precautionary principle: it should therefore be selected.

7.37.3    Monitoring, reporting and administrative streamlining options 

Error! Reference source not found. summarises the impacts of implementing the monitoring, reporting and administrative streamlining options, compared to the status quo. The options presented are not mutually exclusive.

Table 7.3.1: Monitoring, reporting and administrative streamlining – preferred options

88     Preferred Policy Package 

8.18.1    Preferred options summary

The preferred policy options are aggregated in Table 8.1 . 1 below. The package of options all surface and groundwater options and the digitalisation, administrative streamlining and better risk management options marked as preferred in the preceding chapter.

Table 8.1.1: Preferred policy initiatives

8.28.2    Overall magnitude of impacts

The proposed policy package ensures that legislative changes remain proportionate, i.e. that societal and environmental benefits are larger than economic costs incurred and that the issues are best addressed at EU level. An overview of direct and indirect costs and benefits associated with the options is provided in Annex 3.

As set out in the introduction to section 6 it is not possible, in this impact assessment, to identify the isolated cost and benefit of listing substances since this will depend on measures chosen by MS and on distance to target in the concerned water bodies. Moreover, water legislation works in sync with other legislation (waste water treatment, source control, international requirements, etc). Figures mentioned are therefore often related to estimated costs / benefits from groups of substances with similar characteristics or effect.

For surface water, significant direct adjustment costs are expected for instance from the fact of adding ibuprofen, glyphosate, PFAS, Bisphenol-A and Silver to the PS list, as well as from the amended EQS of PAHs, mercury and nickel. In relation to groundwater, the most significant costs are expected for PFAS, associated with the restriction of use (e.g. in fire-fighting foams - up to €390 million/year per substitute use) and the management of contaminated bio-solids (up to €755 million/year for incineration and €201 million/year for landfilling at EU level). The cumulative costs of the preferred digitalisation, administrative streamlining and better risk management options are of an administrative nature, initially materialising at EU level and generally low (below €1 million), with the possible exception of the automated data delivery mechanism.

It is worth noting that costs cannot be attributed solely to this initiative, due to inevitable interactions and synergies with many other EU policies tackling the same substances. The costs of pollution are mostly internalised through the IED and the UWWTD, the future ban on all PFAS except in essential uses, the implementation of the microplastics initiatives and others. For example, the revision of the UWWTD will boost the upgrade of many UWWTPs, and introduce extended producer responsibility (EPR) to cover the costs, which will significantly reduce the load of micropollutants (like pharmaceuticals and microplastics) entering surface and groundwaters.

The proposed initiative will contribute to the benefits of water policy primarily by reducing concentrations of acutely toxic and/or persistent chemicals in surface and groundwater. It will also improve the value of the aquatic ecosystems and of the services they deliver. However, the valuation of these benefits is challenging. First, this is because it is difficult to attribute benefits to specific measures. Many measures are multifunctional and have multiple benefits that contribute to the objectives of several policies. A second challenge is that the evaluation of benefits requires taking account of various non-quantifiable and location-specific factors, which limits the potential for aggregation and accurate monetisation (this is the case in particular for ecosystem services).

Nevertheless, this impact assessment concludes that overall benefits for society outweigh costs considerably, based on reduced impacts on the environment, human health, pollinators and agriculture, as well as avoided costs of water treatment. For example, annual healthcare costs related to endocrine disruptors’ exposure are estimated to be €163 billion, whereas hypertension brought about by background PFAS exposure contributes to an estimated €10.7-35 billion of annual health costs. The annual health benefits from lowering the risks of PFAS exposure are estimated to be at least €52-84 billion in the EEA countries. The annual avoided costs from not using reverse osmosis to remove PFAS from DW are estimated to be at least €9.13 billion. Not having to use reverse osmosis would also lower by 20% the amount of water extraction needed to produce drinking water. In addition, the annual costs associated with treating BPA-containing leachate from landfills are estimated at around €103.7 million (assuming 25-year lifetime), whilst the costs of end-of-pipe removal of microplastics from waste water are estimated to be between €0.76-3.14 billion per year. Regulating background levels of these chemicals in surface and groundwater bodies is important to drive down emissions, hence avoiding or significantly reducing these costs. When assessing the annual health benefits from the health and environmental effects of nanosilver 79  the possible role of silver in antimicrobial resistance is a relevant issue and is therefore included.

These costs and benefits should be understood as the joint result of all policy actions by EU and Member States that address the concerned pollutants, and should therefore not be seen as the result of this initiative alone.

The preferred policy package will result in water quality improvements contributing to the achievement of the main objective of this review, in line with the Zero Pollution and Biodiversity targets. As water quality issues (especially those caused by emerging pollutants) have a clear cross-border dimension, they need to be addressed at EU level to ensure a uniform level of protection for EU citizens and ecosystems. Considerations of proportionality have been embedded into the legislative review so that decisions are guided by the presence (or absence) of an EU-wide risk. Where no such risk was identified, flexibility was left for MS to set their own TVs.

8.38.3    One In, One Out

In the context of the ‘one in, one out’ approach to which the Commission committed, it is important to pay specific attention to the costs and implications to business, especially small and medium sized enterprises. Costs to business, including the agriculture sector related to this initiative include: (i) administrative costs; (ii) costs related to fertiliser and pesticide management, adjusted feed techniques and sampling, and waste water treatment; (iii) taxes and fees for the cost recovery of water services and activities with a significant impact on the environment; and (iv) in certain cases, costs of substitution. Costs on business and administration will be felt more upstream due to the need to limit emissions during production or find substitutes for certain substances. Benefits may be felt rather by business downstream, such as the waste water treatment sector and the drinking water producers, as well as water users such as farmers and building sector.

Administrative costs cannot be assessed at the level of businesses, since MS will take very different measures to comply, considering the characteristics of the water body and the distance to target of the substances proposed for listing. Administrative expenses at EU level, in particular those linked to the monitoring, reporting and administrative simplification options, are specified in section 6. Those costs range from € 1.9 to 2.3 million for the guidances (effect based methods), methodology for microplastics, repository of RBSPs and groundwater watchlist analysis, of which €1 million is annually recurring. Administrative expenses at MS level associated with monitoring pollution are overall expected to increase, due to the increased number and different nature (like microplastics and groundwater) of substances covered by the legislation. Cumulative costs are estimated between €9 and 15.1 million annually across the EU-27 (thus estimated at around 0.33 million to €0.55 million per year per MS). Both the European Environment Agency and the European Chemicals Agency will be tasked to carry out tasks on the water quality data access and the risk assessment of pollutants respectively, leading to annually recurring costs in the form of additional staff.

8.48.4    REFIT 

In line with the FC of 2019 and with the more holistic Monitoring Framework put in place by the 8th Environmental Action Programme, several elements of the existing Directives will be clarified and simplified in the legislative proposal on the basis this IA. This concerns notably the requirements related to reporting and data sharing. An improved collection of digital information at EU level which allows improved understanding of pollutants in EU waters (and so better targeting of measures), is likely to reduce the administrative burden of MS in the medium-long term. In addition, through digitalisation the comparability of MS data can be more closely aligned, ultimately increasing the transparency of data by publishing them on an online, centralised platform. This would also be beneficial for increased compliance of MS with provisions of the EU INSPIRE Directive, e.g. by using the INSPIRE Geoportal for this purpose. Digitalisation also helps to act independently of reporting timeframes, thus making data available more often and closer to real time. This would be beneficial for MS authorities, to demonstrate progress at national scale, and better empower civil society too.

The revised Directives will introduce monitoring obligations for the newly listed substances while removing the obligations related to deselected substances. The extent to which the monitoring obligations trigger follow-up actions to reduce the emissions of those substances is limited to water bodies that are not in good status already (currently 59% of surface waters (11) (97)). In these cases, MS are obliged to take additional measures to ensure their surface water bodies achieve good chemical status.

The Impact Assessment has differentiated this picture by assessing the expected ‘distance to target’ according to the type of pollutants (see Chapter 0). This revealed that for 13 of the 24 substances or substance groups included in the preferred policy package as additions and for 10 of the 15 substances or substance groups for which a change in EQS values is proposed, the expected distance to target is small to medium. Consequently, for these substances only limited or no additional measures are expected.

A relatively large distance to target is expected only for 10 of 24 (groups of) substances proposed for addition, namely PFAS, four pyrethroid insecticides (Deltamethrin, Esfenvalerate; Permethrin; Bifenthrin), Glyphosate (herbicide), Bisphenol-A (industrial chemical), Silver, and three pharmaceuticals (Carbamazepine, Diclofenac, Ethinylestradiol (EE2)). The same is also expected for Mercury and the flame-retardants Polybrominated diphenyl ethers (PBDEs) for which a change in EQS values is proposed. For Mercury it needs to be noted that this is a ubiquitous substance which is already causing failure to achieve good status in a large number of water bodies, so a revision of its EQS will likely not deteriorate the compliance situation significantly.

99    How will actual impacts be monitored and evaluated? 

9.19.1    Indicators of success

The following success indicators were identified for the general objectives of this initiative to help compare the merits of the policy options and facilitate monitoring and evaluation.

1.Increase the protection of EU citizens and natural ecosystems

·Declining concentrations of PS / PHS and ultimately achieving good chemical status for all EU surface waters, groundwaters and coastal waters.

·An agreed EU measuring and monitoring method for microplastics in place by 2025

·A more effective surface and groundwater watchlist mechanism (e.g. introduction of an obligatory GW WL mechanism by 2025)

2.Increase effectiveness and reduce administrative burden

·Introducing automated data delivery mechanisms for reporting water monitoring data

·Using delegating acts for future revisions of the list of water pollutants

These indicators will support, and feed into the integrated monitoring of pollution that has been created by the Commission’s Zero Pollution Action Plan.

9.29.2    Monitoring and evaluation under the existing EU water quality legislation

The existing WFD has a 6-yearly reporting cycle. In every cycle, MS report on the state of water in each river basin to the Commission, through the EEA. The EEA utilises this data to produce a State of Water report. The monitoring results for individual PS/ PHS feed into chemical status assessments (pass/fail) per WB. The Commission uses the information to assess the RBMPs and as a basis to assess compliance with the legislation. MS are required to report the specific measures they have taken to reduce pressures on water quality. As such success can be heterogeneous between different WBs. This heterogeneity learns that success factors also relate to measures in other policy areas. Measures to address mercury levels in surface water largely depend on measures to tackle Hg-emissions from the combustion of coal in large combustion plants, and pesticide emissions relate to DSUP measures.

The monitoring and reporting obligations under the WFD will remain the key indicators to track progress against the objectives of this revision. For surface and groundwater, the timeliness, and the completeness of reporting, broken down by MS, pressure source and pollutants, will be the main tools to evaluate and continuously monitor progress. However, more frequent periodic (and obligatory) reporting and sharing of information by MS will be introduced as a result of the preferred policy package (e.g. by the mandatory GW WL).

Currently, data reach the public domain with considerable delays. For example, the 2018 EEA State of Water report is based on 2012-2014 data and is, at the time of writing, the most up to date information publicly available at EU level. While acknowledging that an assessment of good status (ecological or chemical) is dependent on many different data put together, better uptake of modern monitoring and digital reporting would allow generating those overviews with a higher frequency than every 6 years, feeding into the 8th EAP Monitoring Framework and the bi-yearly Zero Pollution Monitoring and Outlook Reports. It should also be possible to produce data on individual quality elements. This is in line with digitalisation, administrative streamlining and better risk management options 4 (a repository for sharing best practices regarding available monitoring techniques and their implementation) and 5 (an automated data delivery mechanism to ensure shorter intervals of monitoring, while streamlining reporting).

9.39.3    Joint monitoring and evaluation

In addition to the monitoring established under the WFD and the improvements proposed in this initiative, monitoring of water pollutants in EU laws that address pollution is crucial. In particular, the monitoring provisions included in the revised Industrial Emissions Portal (formerly: E-PRTR), UWWTD and other relevant legislation will be used to assess the policy effectiveness. Currently, the E-PRTR does not require reporting of PFAS emissionsHowever, PFAS is one category of substances that is envisaged to be added to the Industrial Emissions Portal Regulation based on the Commission proposal for revision. Automated links with the most recent lists of water polluting substances under this initiative are envisaged.

This initiative is related to many other work strands under the ZPAP which are ongoing or only starting to deliver results. By 2025 the Commission will take stock of the degree of implementation of the ZPAP action plan, building on the second Zero Pollution Monitoring and Outlook Report. The water quality monitoring in the MS will help evaluate the success of the present initiative, which will realistically only start to become visible after 2027. Combining the output and outcome indicators of those pieces of legislation with the impact indicators set by assessing “good chemicals status” will give a measure of whether the health and ecosystem benefits have been achieved or where there are gaps in implementation.

Proper monitoring and reporting is key to ensure compliance with the Directive and to allow EU and MS to adjust policies in case these appear not to deliver the desired effects. In order for the legislative changes to become operational and effective, compliance at MS level must be secured. An important part of compliance assurance will be done through sectoral legislation (IED, UWWTD, Sustainable Use of Pesticides, REACH, Mercury Regulation, etc.) setting requirements for polluters, but also through the Environmental Liability Directive and Environmental Crime Directive which are currently under revision. The existing WFD contains several provisions that, in combination with the above-mentioned legislation, lay down a comprehensive compliance assurance mechanism. The more continuous availability of monitoring and status data (a combined effect of policy options 2a, 2b, 5 and 6) both to the European Commission and the general public will increase the overall enforceability of the legislation. The creation of a mandatory groundwater watch list (Option 7) will lead to a more structured involvement of stakeholders in prioritising action on the most harmful substances, likely enhancing their interest in compliance.

Annex 1: Procedural information

1.Lead DG, Decide Planning/CWP references

The preparation of this impact assessment was led by Unit C1 Sustainable Freshwater Management within DG Environment, with support from DG Joint Research Centre, Unit D2 Water and Marine Resources. The file concerns the revision of the lists of pollutants and corresponding regulatory standards under the WFD, EQSD and GWD. These Directives were evaluated according to Better Regulation guidelines. The Decide planning number is PLAN/2020/8554 - Revision of lists of pollutants affecting surface and groundwaters.

2.Organisation and timing

2.1.Commission internal process - Inter Service Steering Groups

The Inception Impact Assessment Roadmap (98) was published on 23 October 2020 with feedback period closed on 20 November 2020.

The inter-service steering group (ISSG) for the impact assessment is the same one as for the Evaluation. It is a shared group with other water and pollution related files: the revision of the UWWTD, the Evaluation of the SSD and the back-to-back Evaluation and impact assessment of the Bathing Water Directive. The ISSG includes members from the following DGs: AGRI (Agriculture), CLIMA (Climate Action), ENER (Energy), FISMA (Financial Stability, Financial Services and Capital Markets Union), GROW (Internal Market, Industry, Entrepreneurship and SMEs), HOME (Migration and Home Affairs), JRC (Joint Research Centre), JUST (Justice and Consumers), MARE (Maritime Affairs and Fisheries), RTD (Research and Innovation), REGIO (Regional and Urban Policy), SANTE (Health and Food Safety), SG (Secretariat General), SJ (Legal Service), TAXUD (Taxation and Customs Union) as well as the EEA (European Environment Agency).

Seven meetings of the ISSG were organised between October 2020 and September 2022, the final meeting being held on 22 September 2022. The ISSG has been consulted on all major deliverables for this file, including the inception impact assessment, the stakeholder consultation, including stakeholder consultation workshops, open public consultation and targeted experts survey and key deliverables for the support study prior to its submission to the Regulatory Scrutiny Board. The ISSG that was consulted during this process is identical to the one involved in the REFIT Evaluation of the Directives.

3.Consultation of the RSB

On 15 July 2021 an upstream meeting with the Regulatory Scrutiny Board (RSB) took place. The RSB provided several comments in relation to this file, centred on the following:

·Need to prevent pollution at the source, enforceability and monitoring of the changes to the Priority Substances list and clarifications on the applicability of the precautionary principle;

·Need to establish a Dynamic Baseline Scenario, allowing to account for implications of existing and planned EU legislative initiatives (e.g. Human Pharmaceuticals legislation, Drinking Water Directive, UWWTD, etc.).

The IA was submitted to the RSB on 25 May 2022 and discussed on 22 June. On 24 June the RSB issued its positive opinion with reservations. The points have been addressed as follows: