Explanatory Memorandum to COM(2022)540 - Amendment of Directive 2000/60/EC on water policy, Directive 2006/118/EC on pollution of groundwater and Directive 2008/105/EC on quality standards in water policy

Please note

This page contains a limited version of this dossier in the EU Monitor.

dossier COM(2022)540 - Amendment of Directive 2000/60/EC on water policy, Directive 2006/118/EC on pollution of groundwater and Directive ...
source COM(2022)540 EN
date 26-10-2022


1. CONTEXT OF THE PROPOSAL

• Reasons for and objectives of the proposal

EU water legislation shares an overarching objective of protecting human health and the environment from the combined effects of toxic and/or persistent pollutants. This initiative concerns Directive 2000/60/EC 1 (the Water Framework Directive, or WFD) and its two ‘daughter’ directives, Directive 2006/118/EC 2 (the Groundwater Directive, or GWD) and Directive 2008/105/EC 3 (the Environmental Quality Standards Directive, or EQSD), which together focus on the protection of groundwater and surface waters 4 . They complement other relevant pieces of water legislation, i.e. Directive (EU) 2020/2184 (the Drinking Water Directive, or DWD) 5 , Council Directive 91/271/EEC 6 (the Urban Waste Water Treatment Directive, or UWWTD), Directive 2008/56/EC 7 (the Marine Strategy Framework Directive, or MSFD), Directive 2006/7/EC 8 (the Bathing Water Directive or BD), Directive 2007/60/EC 9 (the Floods Directive, or FD) and Council Directive 91/676/EEC 10 (the Nitrates Directive, or ND).


The legislation includes lists of pollutants and quality standards, and includes requirements for their regular review 11 . Article 16 i of the WFD requires the Commission to regularly review, at intervals of at least every 4 years, the list of priority substances 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 to the WFD (the list of priority substances) while for groundwaters, Article 10 of the GWD requires the Commission to review every 6 years Annexes I and II to the GWD itself. This revision, and the impact assessment, also serve to report to the European Parliament and the Council, as referred to in Article 8 of the EQSD.


The need to update the lists was confirmed in the 2019 fitness check 12 , which also concluded that other improvements to the legislation would increase its effectiveness, efficiency and coherence. 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 13 and the Zero Pollution Action Plan 14 , both embedded in the European Green Deal 15 ;

increase the effectiveness and reduce the administrative burden of the legislation, to enable the EU to repond more quickly to emerging risks.

Chemical exposure through drinking water can lead to a variety of short- and long-term health effects. Chemicals also endanger the aquatic environment, resulting in changes in dominant species and a decrease in or loss of biodiversity. Setting and controlling environmental quality standards (EQS) for chemicals in water bodies complements source and pathway legislation, by pushing for stricter production, emission or use standards where necessary, and reducing the costs of treating drinking water.


The specific objectives of this initiative are to:

Contents

1.

1.update the lists of pollutants affecting surface and groundwater by adding and removing substances and updating existing quality standards;


2.

2.improve the monitoring of chemical mixtures to better assess combination effects and take account of seasonal variations in pollutant concentrations;


3.

3.harmonise, wherever relevant, how pollutants in surface and groundwater are addressed across the EU;


4.

4.ensure that the legal framework can be more swiftly aligned with scientific findings to more promptly respond to contaminants of emerging concern;


5.

5.improve the access to, transparency and re-use of data, to enhance compliance, reduce administrative burden and improve coherence with the wider EU legal framework dealing with chemicals.


The ultimate aim of the initiative is to set new standards for a series of chemical substances of concern to address chemical pollution in water, to facilitate enforcement based on a simplified and more coherent legal framework, to ensure dynamic and up-to-date information on water status, facilitated by the European Environment Agency (‘EEA’), and create a more flexible framework for addressing pollutants of emerging concern. This would be based on wide stakeholder involvement as well as sound scientific support from the European Chemicals Agency (‘ECHA’) to ensure maximum synergies and coherence across EU laws on chemicals.

• Consistency with existing policy provisions in the policy area

The proposal is fully consistent with other legislation on water. As regards the Urban Waste Water Treatment Directive (UWWTD), for which a proposal for revision is presented at the same time as this proposal, micro-pollutants are a key challenge. The need to remove them at waste water treatment facilities drives up the cost of treatment, and removal is not always possible. This proposal therefore aims to stimulate more action upstream by reducing emissions at source. Waste water treatment will be particularly important for some categories of pollutants: pharmaceuticals and substances in personal care products as they are discharged mostly in an urban environment.

By avoiding water pollution, the proposal will also benefit the potential for water reuse, including for irrigation purposes in line with the new Regulation on minimum requirements for water reuse Regulation (EU) 2020/741 16 .

This proposal is also consistent with the recently revised Drinking Water Directive (DWD), which has to be transposed across all EU Member States by January 2023. By tackling surface and groundwater pollution, this proposal will protect vital drinking water sources and reduce treatment costs. The DWD and this proposal address a wide range of pollutants, in particular pesticides, pharmaceuticals and the group of per- and polyfluoroalkyl substances (PFAS). As regards PFAS it should be noted that this proposal has, unlike the revised DWD, benefitted from the most recent EFSA advice on PFAS adopted on 9 July 2020. Like the DWD, this proposal also targets microplastics not immediately but after a methodology for monitoring has been developed. This proposal will be taken into account in the ongoing evaluation of the Bathing Water Directive (BWD) and should the BWD be revised, it will be part of the baseline constructed for the BWD impact assessment.

The proposal is also consistent with the recent Commission proposals 17 to revise EU measures to address pollution from large industrial installations which, in addition to widening the scope of the Industrial Emissions Directive (IED), also seek to improve resource efficiency and ensure that permitting requirements are better controlled and more integrated, including by clarifying rules applicable to the indirect release of polluting substances into water through urban wastewater treatment plants. The proposals further aim at fostering innovation to address persistent chemical substances and substances newly identified as being of concern, including PFAS, micro-plastics and pharmaceuticals. The ‘exchange of information’ process under the revised IED to draw up and review best available technique reference documents will take account of the identification of substances of concern under EU water law, including substances on the ‘watch lists’ for surface and groundwater, as well as substances posing a significant risk to or via the aquatic environment at EU level.

• Consistency with other Union policies

This initiative is part of the 2022 Commission work programme and a key action in the Zero Pollution Action Plan. Like all initiatives under the European Green Deal, it aims to ensure that objectives are achieved in the most effective and least burdensome way and comply with the ‘do no significant harm’ principle. It fine-tunes, updates and adapts existing legislation in the context of the Green Deal. Its focus is on defining the zero pollution ambition for water pollutants and thereby the level of protection for human health and natural ecosystems. Many measures necessary to achieve are addressed by other, closely related, European Green Deal initiatives. These include:

·The Biodiversity Strategy and the Farm to Fork Strategy 18 , which aim to reduce pesticide use, fertilizer use, nutrient losses and the sales of antimicrobials by 2030. Much of the reduction in pesticide use is to be achieved by the Commission’s proposal 19 for a Regulation of the European Parliament and of the Council on the sustainable use of plant protection products and amending Regulation (EU) 2021/2115. A future review of Regulation (EC) No 1107/2009 20 concerning the placing of plant protection products (PPPs) on the market could also play a role;

·The EU Plastics Strategy 21 and the upcoming EU micro-plastics initiative, which aim to deliver on the Zero Pollution Action Plan targets to reduce waste, plastic litter at sea and micro-plastics released into the environment by 2030;

·Directive (EU) 2019/904 22 (the Single Use Plastics Directive, or SUPD), which aims to limit the use of single-use plastic products, for example by introducing waste management and clean-up obligations for producers (including extended producer responsibility schemes);

·The Circular Economy Action Plan 23 , which announces in particular measures to reduce micro-plastics and an evaluation of Council Directive 86/278/EEC 24 (the Sewage Sludge Directive, or SSD), regulating the quality of sludge used in agriculture;

·The Chemicals Strategy for Sustainability 25 , 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 Strategy also sets the objective to move towards a ‘one substance, one assessment’ approach by improving the efficiency, effectiveness, coherence and transparency of safety assessments of chemicals across all relevant legislation. For this reason, this proposal assigns a central role to ECHA to undertake the role of scientific support to future identification of water pollutants as well as proposing relevant quality standards;The 2019 Strategic Approach to Pharmaceuticals in the Environment 26 (flowing directly from the 2013 revision of the EQSD) and the Pharmaceuticals Strategy for Europe 27 , 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 upcoming revision of the legislation on human medicinal products is expected to provide appropriate follow-up. Similarly, by listing several antimicrobial drugs as well as the metal silver, this proposal is consistent with the EU’s strategy in the area of antimicrobial resistance;

·The European Strategy for Data 28 , which underlines that data generated by the public sector should be available for the common good, so that they can be appropriately used, for instance by researchers, other public institutions, and small and medium-sized enterprises (SMEs).

·This proposal is also consistent with 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. 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’.:

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

• Legal basis

The legal basis for this proposal is Article 192 of the Treaty on the Functioning of the European Union (TFEU). In accordance with Articles 191 and 192(1) TFEU, the EU is required to contribute to the pursuit of preserving, protecting and improving the quality of the environment; promoting measures at international level to deal with regional or worldwide environmental problems; and combating climate change.

• Subsidiarity (for non-exclusive competence)

Surface and groundwater bodies in the EU are polluted by a range of pollutants. Pollution travels downstream and underground, and 60% of European river basin districts are international (either shared between Member States or between a Member State and a non-EU country). For this reason, cooperation between Member States is essential and action at EU level necessary to address pollution and other transboundary impacts by setting harmonised standards and establishing harmonised data collection and sharing systems. Without action at EU level, it would become prohibitively expensive, especially for downstream Member States, to address pollution.

The 2019 fitness check of EU water legislation confirmed that the WFD and its two daughter directives have triggered or reinforced action to address the transboundary pressures on water resources at river basin level, both nationally and internationally.

Specifically in relation to pollutants, the legislation distinguishes between substances considered to present a risk at EU level and substances of regional or national concern, and addresses them differently. This initiative seeks to improve how substances of regional and national concern are dealt with by the Member States.

Where EU environmental quality standards are set, the EU introduces common objectives to achieve the zero pollution ambition on the basis of scientific evidence, but leaves Member States the flexibility to decide on the most cost-effective way to achieve these objectives, taking into account relevant EU source-based legislation. In doing so (common objectives with flexibility for achieving those), it creates a link with the source-based legislation at EU level (such as the sustainable use of pesticides) and helps ensure an effective delivery of the aims set in that legislation.

• Proportionality

The proposal revises the existing lists of surface and groundwater pollutants and sets or updates environmental quality standards for Member States to meet, whilst relying to a large extent on other EU legislation addressing the source of pollution or regulating their emissions during production and use (such as restrictions on the use of certain substances under REACH 29 or emission limit values set out in permits of industrial installations under the IED) and leaving the choice of specific measures to the Member States. As each water body in the EU has its own specific characteristics (climate, flow, geological conditions, etc.) and is not necessarily subject to the same pressures as other water bodies, leaving the choice of measures to the Member States’ water authorities is correct from a proportionality standpoint.

The 2019 fitness check of EU water legislation confirmed the added value of the WFD, EQSD and GWD. The impact assessment for this proposal confirms that the substances considered for addition to the pollutant lists with EU-wide quality standards present a risk at EU level. A small number of already listed substances were identified that are no longer considered substances of EU-wide concern, but which might still need to be addressed at national level. This proposal sets out a procedure enabling the European Commission to address inconsistences in how Member States decide on substances to regulate at national level and on the quality standards to set for them.

• Choice of the instrument

The initiative takes the form of a directive because this is the most appropriate legal instrument to make amendments to the existing, relevant directives.

A directive requires Member States to transpose the provisions into their national substantive and procedural legal systems and implement measures that will achieve the objectives. This approach gives Member States more freedom than a regulation, as Member States can choose the most appropriate measures to achieve the agreed result obligations.

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

• Ex-post evaluations/fitness checks of existing legislation

In 2019, a fitness check evaluation of EU water legislation was completed covering the WFD, the EQSD, the GWD and the FD. The fitness check concluded that, although the legislation is largely fit for purpose, there is room for improvement in relation to tackling chemical pollution. The fitness check found that, overall, there are three reasons why only limited progress has been made towards achieving the overall objectives of the legislation:

inadequate integration of water objectives into other relevant policies;

inadequate investment in Member States in water-related projects and programmes;

inadequate implementation efforts.

As regards implementation, several deficits were highlighted in relation to chemical pollution: the large diversity in quality standards for nationally relevant pollutants, the administrative burden associated with reporting, the lack of specificity and timeliness of reported information and the resource-intensive, time-consuming process for updating the lists of pollutants. This proposal addresses these deficits. In addition, it takes account of relevant findings from the 2019 fitness check of the most relevant chemicals legislation 30 and the commitments made in the Chemicals Strategy for Sustainability. In particular, it takes a step towards more holistic (mixture) monitoring by introducing the use of effect-based methods, and includes provisions to improve the timeliness, efficiency and coherence of hazard and risk assessment (for example by facilitating data-sharing and the application of the ‘one substance, one assessment’ approach).

6.

Regulatory fitness and simplification (REFIT)


The Impact Assessment considered options for simplification and burden reduction. The removal of substances, from the list of surface water pollutants, constitutes a limited reduction of burden, as does changing the revision of the watchlist to every three years rather than two, and the revision of the lists of surface water and groundwater pollutants through delegated acts rather than through co-decision. The creation of an automatic data delivery mechanism under WFD and EQSD will reduce reporting burden on the Member States, as will the abolition of the interim report on the programme of measures under Article 15(3) of the WFD. Improving the existing guidelines for Effect-Based Methods and developing a harmonised methodology for monitoring microplastics will simplify Member States’ work in these areas.

In developing the Impact Assessment, the basic characteristics of the SME-test have been applied and results noted in particular in section 6. SMEs are active in the production and use of the relevant pollutants. It should be noted that precise identification and quantification of impacts is generally not possible due to the fact that impact will depend on measures that Member States take to achieve the objectives of the legislation.

7.

Opinion of the Regulatory Scrutiny Board


The Regulatory Scrutiny Board issued, on 24 June 2022, a positive opinion with reservations. It requested changes to rectify in particular three aspects: (1) the design of the options, which was considered to be overly complex and not bringing out clearly the key policy choices; (2) the impacts on SMEs and on citizens which were not considered to be analysed sufficiently, with the report not assessing how individual Member States may be affected; (3) the report was not considered to be clear about the order of magnitude of the expected impacts, not to critically assess the validity of the illustrative benefit and cost estimates and their relevance to the initiative, and the comparison of options not thought to be based on their effectiveness, efficiency and coherence.

In response, the policy options have been simplified, by reducing the number of options and aggregating options. The impacts on SMEs have been developed further throughout the text, as was information on impacts on consumers and on Member States. The interpretation of cost and benefit figures has been clarified to avoid the impression these can be interpretated as solely linked to this initiative. The text on One In, One Out has been completed. Finally the assessment of effectiveness, efficiency and coherence for the options has been added to the text.

• Stakeholder consultations

Extensive stakeholder consultation took place to support the preparation of this proposal. Based on the Commission’s Better Regulation guidelines, both an open public consultation and an expert survey took place in 2021, with results feeding into the impact assessment for this proposal. The permanent network of Member States and stakeholders supporting the implementation of the WFD and its daughter directives was kept informed, and in particular the Working Groups on Chemicals and Groundwater were consulted extensively.

For the individual substances and groups of substances identified for listing as surface water pollutants, extensive technical dossiers were prepared by the Commission’s Joint Research Centre (JRC), supported by sub-groups of Member State and stakeholder experts. Finally, as part of the review by the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER), preliminary opinions were published (while observing a four week commenting during period), with results feeding into the SCHEER opinion. For a few substances, the review is not finalised. The proposed values have therefore been marked as ‘subject to confirmation in the light of the opinion requested from the SCHEER’. All final proposed values will be fully consistent with the scientific advice.

• Collection and use of expertise

Internal expertise was provided by the JRC, in particular for the selection of surface water pollutants and the derivation of environmental quality standards (EQS). External technical expertise, including on groundwater pollutants, was provided by experts from the Chemicals and Groundwater Working Groups. The Commission’s impact assessment was supported by a study prepared by external consultants, which reviewed the economic, social and environmental impacts of a range of potential policy options, taking account of the expected impacts of existing and planned policies at EU level and inputs from stakeholders. The JRC substance dossiers, reports from the Groundwater Working Group, the consultants’ study report and stakeholder workshop reports are available in CIRCABC 31 .

• Impact assessment

The impact assessment examined the three groups of options, i.e. options relating to surface waters, options relating to groundwaters, and cross-cutting options. For surface waters, it assessed the impact of adding a range of substances (from among reviewed pharmaceuticals, pesticides, industrial chemicals and metals) to the list of priority substances, and thus of setting EU-wide EQS for them. For several existing priority substances, it reviewed the impact of changing their EQS (on the basis of new scientific evidence). For some other existing priority substances, it examined the impact of removing them from the list. For groundwaters, the impact assessment reviewed the impact of adding specific (groups of) substances to the list, namely PFAS, non-relevant metabolites of pesticides (nrMs) and pharmaceuticals. Lastly, the impact assessment reviewed a range of options to improve digitalisation, administrative streamlining and risk management in the area of water pollution.

The main sources of pollution for the identified substances are chemical production processes (direct emissions resulting from production of wood, pulp, steel, combustion, textiles, plastics etc.); waste water discharges including pharmaceuticals and chemicals as a wash-off of fabrics, consumer products, cleaning products, personal care products; indirect discharges resulting from pesticides, biocides and pharmaceuticals’ use in agriculture; chemicals used in road construction; the deposition of mercury from fossil fuel combustion plants and of PFAS from fire-fighting foams. All these sources and pathways are subject to legislation, including the Industrial Emissions Directive 2010/75/EC (under revision), the Urban Waste Water Treatment Directive 91/271/EEC (under revision), Directive 2009/128/EC on the sustainable use of pesticides (under revision), Directive 2001/83/EC on medicinal products for human use, Regulation (EU) 2019/6 on veterinary medicinal products, the REACH Regulation No 1907/2006, Regulation (EC) No 1107/2009 on plant protection products, Regulation (EU) No 528/2012 on biocidal products; and Regulation (EC) No 1223/2009 on cosmetics. By setting maximum concentration limits for these substances, this proposal aims to reinforce the effect and implementation of EU source and pathway legislation and, where so required for the purpose of protecting health or the environment, push for the adoption of stricter source/pathway measures at Member State level.

The options were reviewed against their environmental, social and economic costs and benefits, resulting in the following package of preferred options:

Surface water
Option 1: Addition to PS list as an individual substance with EQS set for each individually23 individual substances:

17-Beta estradiol (E2); Acetamiprid; Azithromycin; Bifenthrin; Bisphenol A; Carbamazepine; Clarithromycin; Clothianidin; Deltamethrin; Diclofenac; Erythromycin; Esfenvalerate; Estrone (E1); Ethinyl estradiol (EE2); Glyphosate; Ibuprofen; Imidacloprid; Nicosulfuron; Permethrin; Thiacloprid; Thiamethoxam; Triclosan, Silver.
Option 2: Addition to PS list as a group with EQS set for “sum of”PFAS (sum of 24 named substances)
Option 3: Amendment of existing EQS14 substances to more stringent:

Chlorpyrifos; Cypermethrin; Dicofol; Dioxins; Diuron; Fluoranthene; Hexabromocyclododecane (HBCDD); Hexachlorobutadiene; Mercury; Nickel; Nonyl Phenol; PAHs; PBDEs; Tributyltin

2 substances to less stringent:

Heptachlor/heptachlor epoxide; Hexachlorobenzene
Option 4: Deselection4 substances: Alachlor; Carbon tetrachloride; Chlorfenvinphos; Simazine
Groundwater
Option 1: Addition to Annex I with GW QS set for each individually2 pharmaceutical substances: Carbamazepine and Sulfamethoxazole

All nrMs with individual GW QS of 0.1 µg/l
Option 2: Addition to Annex I with GW QS set for “sum of”PFAS (sum of 24 named substances)
Option 3: Addition to Annex II1 substance: Primidone
Digitalisation, administrative streamlining and better risk management
Option 1: Provide guidance and advice on monitoringbImprove existing EBM guidelines to improve the monitoring of groups/mixtures of pollutants by using EBMs.
cDevelop a harmonised measurement standard and guidance for microplastics in water as a basis for MS reporting and a future listing under EQSD and GWD.
Option 2: Establish/amend obligatory monitoring practicesaInclude an obligation in the EQSD to use EBMs to monitor estrogens.
bEstablish an obligatory Groundwater Watch List analogous to that of surface waters and drinking water and provide guidance on the monitoring of the listed substances.
cImprove the monitoring and review cycle of the Surface Water Watch List so that there is more time to process the data before revising the list.
Option 3: Harmonise reporting and classificationaEstablish an automated data delivery mechanism for the EQSD and the WFD to ensure easy access at short intervals to monitoring/status data to streamline and reduce efforts associated with current reporting, and to allow access to raw monitoring data.
bIntroduce a repository of environmental quality standards for the RBSPs as an Annex to the EQSD, and incorporate RBSPs into the assessment of surface waters’ chemical status.
Option 4: Legislative and administrative aspectsaUse EQSD instead of WFD to define the list of priority substances, and update the lists of SW and GW pollutants by Comitology or delegated acts.
bChange the status of Aldrin, Dieldrin, Endrin, Isodrin, DDT, Tetrachloroethylene and Trichloroethylene from ‘other pollutants’ to that of priority substances.
cChange the status of 1,2 dichloroethane, fluoranthene, lead, octylphenol ethoxylates and pentachlorophenol to that of priority hazardous substances.


The proposed policy package ensures that legislative changes remain proportionate, with economic, social and environmental benefits larger than the corresponding costs, and that they focus on issues that are best addressed at EU level.

Quantifying the costs, and especially the benefits, of this initiative is difficult, given its interaction with (and reliance on) other policy initiatives for certain EU-wide measures. Furthermore, Member States can largely choose which measures they implement to achieve compliance: these will thus vary according to national/local circumstances.

For surface water, significant direct costs are expected for instance from adding ibuprofen, glyphosate, PFAS and bisphenol A to the priority substances list, as well as from amending the EQS for polyaromatic hydrocarbons (PAHs), mercury and nickel. This is likely to cause product development costs for industry and substitution costs for users of those substances, including in the agricultural sector.

In relation to groundwater, the most significant costs are likely to arise from adding quality standards for PFAS. Costs may be related to restricting the use of pesticides or industrial chemicals, for example, to managing contaminated bio-solids and stepping up the treatment of waste water. The costs of the preferred digitalisation, administrative streamlining and better risk management options are of an administrative nature, would initially materialise at EU level and generally be low, with the possible exception of the automated data delivery mechanism. Costs cannot be attributed solely to this initiative, due to inevitable interactions and synergies with many other EU policies tackling the same substances. The pollution costs are mostly internalised through the IED and the UWWTD, the future ban on all PFAS except in essential uses, the implementation of the upcoming micro-plastics initiative and others. For example, the revision of the UWWTD will boost the upgrade of many UWWTPs, and introduce extended producer responsibility to cover the costs, which will significantly reduce the load of micro-pollutants entering surface and groundwaters.

The proposed initiative will contribute to reducing concentrations of acutely toxic and/or persistent chemicals in water. It will also improve the value of the aquatic ecosystems and of the services they deliver. Benefits thus include reduced impacts on human health, nature, pollinators and agriculture, as well as avoided costs of water treatment. Making the chemical monitoring data easily available, accessible and re-usable will significantly improve the coherence of safety assessment, and will be an important step in moving towards the ‘one substance, one assessment’ approach committed to in the EGD.

8.

Sustainable Development Goals


The proposal has positive effects on the achievement of Sustainable Development (SDG) goals 6 (water), 12 (consumption and production) and 14 (oceans). As regards SDG 6, lower levels of pollution of drinking water sources are expected, a better chemical quality of surface and groundwater, and the proportion of water bodies with good ambient quality should increase, over time, as Member States will take and implement measures to reduce concentrations of pollutants. In relation to SDG 12, it is expected that the measures taken, both at EU level (for instance through the Sustainble Production Initiative or the forthcoming ban on all-but-essential uses of PFAS) and at Member State level will lead to the use of different, less toxic ingredients in products. Finally for SDG 14 it is important to note the directe effect on transitional water bodies and marine water bodies (1 nautical mile from the coast) that are covered by the WFD. In addition the freshwater that reaches seas and oceans through the rivers will gradually contain lower concentrations of the substances regulated through this initiative.

9.

Climate consistency check and Energy Efficiency First Principle


The proposal is consistent with climate neutrality objective set out in the European Climate Law and the Union 2030 and 2050 targets. The most significant impact on climate mitigation efforts of the proposal is through the removal of substances in waste water treatment plants, which are energy intensive processes. Depending on the measures taken by Member States to reduce or phase out presence of substances in water, impact should be positive (when substances are addressed at source and therefore do not require removal from waste water), neutral (in case substances are replaced by substitutes that require the same removal effort in waste water treatment plants) or negative if Member States decide to predominantly rely on waste water treatment. However the latter scenario is unlikely as at-source intervention is generally cheaper and more effective. Moreover, the revision of the Urban Waste Water Treatment Directive requires climate neutrality for waste water treatment plans by 2040, excluding net negative effects of this proposal through increased treatment.

The Energy Efficiency First Principle, as put forward in the recast of the Energy Efficiency Directive, is considered in this proposal. Along the same lines as for climate consistency check, policy options can be expected, in combination with the revision of the Urban Waste Water Treatment Directive, to be at least neutral in terms of energy efficiency.

The Regulatory Scrutiny Board gave a positive opinion with reservations on 24 June 2022 32 .

• Fundamental rights

The proposal has no implications for the protection of fundamental rights.

4. BUDGETARY IMPLICATIONS

The annexed financial statement relates to the zero pollution package, including the current proposal, the proposal for revision of the Urban Waste Water Treatment Directive and the Air Quality Directive. It shows the budgetary implications and the human and administrative resources required. The proposal will have budgetary implications for the Commission, the European Environment Agency (EEA) and the European Chemicals Agency (ECHA) in terms of human and administrative resources required.

The Commission’s implementation and enforcement workload will slightly increase as a result of listing more substances and seeking to harmonise quality standards and threshold values for substances of national concern.

The Commission will furthermore benefit from the re-assignment of scientific tasks to the ECHA, which will consistently assist the Commission with the prioritisation of substances and mixtures, the setting of quality standards and threshold values, the identification of appropriate analytical methods and the assessment of relevant monitoring data. The scientific support from ECHA would require eleven full-time-equivalent staff.

The EEA will have an increased workload as a result of the increased and more frequent reporting required of Member States, and the slight increase in the number of substances listed, requiring in total four additional full-time-equivalent staff on top of the three and a half staff full-time equivalent staff already involved.

5. OTHER ELEMENTS

• Implementation plans and monitoring, evaluation and reporting arrangements

The River Basin Management Plans reported every six years to the Commission and the voluntary electronic reporting under the Common Implementation Strategy to the EEA will remain the key source of information to verify effective implementation of the proposal, in particular of compliance with new or revised quality standards for surface and groundwater.

The improved watch list mechanisms, which oblige Member States to monitor substances of emerging concern, will make it possible for the Commission, with the assistance of ECHA and the Member States, to identify the need for further or stricter quality standards. The more regular reporting of also actual monitoring data, and its analysis by the EEA, will enable the EU Institutions, Member States and the public at large, to obtain a more accurate and up-to-date picture of the status of surface and groundwater bodies in the EU.

Thanks to synergies with the improved E-PRTR, due to be replaced by the new online electronic database, i.e. the ‘Industrial Emissions Portal’, the inventories of emissions, currently only reported every six years, will be replaced by a far more regular and coherent overview of total releases of pollutants per sector. This will enable the Member States to focus implementation efforts.

The Annexes of both Surface and Groundwater Directives will be reviewed regularly in the light of scientific and technical progress. The more flexible procedures for adopting quality standards for substances of concern, in combination with the central roles given to the EEA, for the analysis of more regular monitoring data, and to the ECHA, for continuous scientific support, will allow to better evaluate the accuracy of current standards and the need for new ones, to swiftly address substances of emerging concern. The involvement of both Agencies complies with the objective under the Chemicals Strategy to move towards ‘one substance, one assessment’ approach resulting in more efficient, effective and coherent safety assessments of chemicals across all relevant EU legislation, thereby also triggering more effective and cross-cutting implementation measures and proposals for new standards.

The analysis of more regular monitoring and status data will effectively feed into the broader Zero Pollution Monitoring and Outlook framework, to be published every 2 years from 2022. This will help evaluate the impact of reduced pollution of water bodies as a result of a wider set of harmonised quality standards being implemented across the EU.

• Explanatory documents

The proposal requires explanatory documents, because these are key for assessing conformity and verify that the transposing texts reflect the letter and the spirit of the Directive. This is important and necessary, as the proposal covers amendments to three directives, possibly transposed in different pieces of national legislation. Also, since the proposal primarily aims at amending existing or introducing new quality standards, a careful verification can be facilitated through explanatory documents.

• Detailed explanation of the specific provisions of the proposal

(1)Amendments to Directive 2000/60/EC

Articles 1, 7(2), 11(3)(k), 4(1) and Annexes V (points 1.4.3, 2.3.2 and 2.4.5) and VII (point 7.7) are amended to take into account the proposed deletion of Articles 16 and 17 (see below).

Article 2 on definitions is amended to update the definitions of ‘Good surface water chemical status’, ‘Priority Substances’ and ‘Environmental quality standards’ and introduce the definitions of ‘Priority hazardous substances’ and ‘River basin specific pollutants’. These changes are necessary to: 1) take account of the proposal to replace the current co-decision procedure for adopting EQS with delegated acts; 2) widen the scope of the notion of ‘chemical status’ to cover also the ‘river basin specific pollutants’, hitherto part of the definition of ‘ecological status’ under Annex V; 3) take into account the possible future effect-based trigger values as part of the definition of ‘environmental quality standards’.

Article 3 on administrative coordination within river basin districts is amended to introduce an obligation, in case of exceptional circumstances of natural origin or force majeure, in particular extreme floods, prolonged droughts, or significant pollution incidents, for competent authorities of all possibly affected water bodies including in downstream Member States, to alert each other and cooperate to minimize damage and address consequences.

Next to the above-mentioned adjustment to take account of the deletion of Article 16, Article 4 on objectives is amended to ensure that its paragraph (a)(iv) includes an explicit obligation for Member States to progressively reduce pollution from river basin specific pollutants too, not just from priority substances.

Article 8, paragraph 3 on methods for analysing and monitoring the water status is amended to align the comitology procedure to the Lisbon Treaty by replacing the former ‘regulatory procedure with scrutiny’ with the ‘examination procedure’ set out in Article 21. In addition, a new empowerment is introduced in the same paragraph to allow for the adoption of implementing acts to set further details as regards the new obligations to make available to the EEA monitoring data, as well as to make status data available on a more regular basis, in accordance with new paragraphs 4 and 5. These amendments are fully in line with existing obligations under Directive 2007/2/EC (Inspire), which obliges Member States to make publicly available spatial data sets, including on the location and operation of environmental monitoring facilities, related emission measurements and the state of the environmental media (air, water, soil). To reduce administrative burden, data dissemination should be further streamlined too, in accordance with the EU Digital Strategy, Directive (EU) 2019/1024 on open data and the ‘one substance one assessment’ approach under the Sustainable Chemicals Strategy.

Article 10 on the combined approach for point and diffuse sources is amended to update the references to various directives addressing point source and diffuse pollution (further to their repeal and replacement).

Article 12 on issues that cannot be dealt with by one Member State is modified to strengthen and formalise the procedure for cooperation between Member States.

Article 15(3) on the three yearly, interim reporting of progress on programmes of measures is deleted, as the resulting administrative burden is considered disproportionate compared to the gains in terms of better implementation control and steering.

Articles 16 and 17 on the procedure by which the Commission was required to establish legislative proposals for listing and identifying EQS for surface water bodies and groundwater bodies are deleted, as they have become obsolete.

Article 18(2)(e) is amended to take into account the proposed deletion of Article 16, whereas Article 18 i is amended to take into account the proposed deletion of Article 15(3).

Article 20 on technical adaptations is amended to: 1) replace with the delegated acts procedure the current regulatory procedure with scrutiny for modifying Annexes I and III; 2) replace with the examination procedure the current regulatory procedure for adopting guidelines on the implementation of Annexes II and V and for establishing formats for the transmission and processing of data.

The new Article 20a introduces the provisions related to the procedure for adopting delegated acts, in accordance with the Lisbon Treaty.

The amendment to Article 21 on the Committee procedure aims at replacing the reference to the former ‘comitology decision’ with the currently applicable ‘comitology regulation’.

Article 22 on repeals and transitional provisions is amended to update the references taking into account the proposed changes to relevant Annexes to Directives 2000/60/EC and 2008/105/EC.

Next to the above-mentioned adjustments to take account of the deletion of Article 16, Annex V is amended to: 1) take out the river basin specific pollutants from the definitions of ecological status and include them in the definition of chemical status, with a view to ensure that the monitoring of both priority substances and river basin specific pollutants is carried out not only where these pollutants are discharged into water, but also where they are deposited through air; 2) grant powers to the Commission to adopt the results of the intercalibration exercise by delegated acts; 3) enable Member States to make use of new monitoring techniques, including earth observation and remote sensing.

Annex VIII on an indicative list of main pollutants is amended to include micro-plastics and antimicrobial resistance genes.

Annex X is deleted, as the list contained therein is replaced by that in Part A of Annex I of Directive 2008/105/EC.

(2)Amendments to the Groundwater Directive 2006/118/EC (GWD)

The title is amended to clarify that this Directive only concerns the pollution and not the quantitative status of groundwaters.

Article 1 on the Directive’s purpose is amended to take out the reference to Article 17 of the WFD, given that it formed the basis for adopting the GWD itself and is thus obsolete.

Article 2 on the definitions is amended to include the definition of threshold values set at EU level, next to those set at Member State level.

Article 3 on criteria for assessing groundwater chemical status is amended to take into account the new definition of ‘threshold values set at EU level’.

Article 4 on the procedure for assessing groundwater chemical status is amended for the same reason as Article 3.

A new Article 6a is inserted to make the ‘Watch List Mechanism’ for groundwater bodies mandatory, consistently with the provision set by Article 8b of the EQSD. This mechanism establishes a three yearly process whereby the Commission, with input from ECHA and in close consultation with Member States, prioritises substances for monitoring in groundwater. The resulting information will feed into the six yearly revision of quality standards for inclusion in Annex I. The provision also includes an obligation for ECHA to make the scientific reports prepared in relation to the Watch List publicly available.

Article 8 on technical adaptations is amended to: 1) replace the procedure for implementing acts with that for delegated acts for adapting to scientific and technical progress Parts A and C of Annex II as well as Annexes III and IV; 2) grant the Commission delegated powers for listing new groundwater pollutants in Annex I and for establishing new EU-wide quality standards for these, as well as for listing, in part B of Annex II, pollutants for which Member States have to consider setting national threshold values; 3) grant the Commission delegated powers to set, where necessary and even for pollutants or groups of pollutants which are not of EU-wide concern, threshold values at EU level, to enhance the level of human health and environmental protection and achieve a more harmonised implementation; 4) clarify the central role of ECHA in this framework, and the obligation for ECHA to make scientific reports in relation to potential amendments publicly available.

A new Article 8a is inserted to introduce the provisions related to the procedure for the adoption of delegated acts, in accordance with the Lisbon Treaty.

Article 9 on the Committee procedure is amended to replace the former ‘comitology decision’ with the more recent ‘comitology regulation’.

Article 10 on the review of Annexes I and II by means of the co-decision procedure is deleted, to take account of the new procedure for delegated acts set out in Articles 8 and 8a.

Annex I on EU wide quality standards for groundwater pollutants is amended to insert new groundwater pollutants and related quality standards for some per- and poly-fluorinated alkyl substances (PFAS), pharmaceuticals and non-relevant metabolites of pesticides (nrMs).

Annex II on national threshold values for groundwater pollutants is amended to: 1) insert the pharmaceutical substance primidone in the list of synthetic substances for which Member States shall consider setting national threshold values; 2) clarify that its Parts B and C only relate to the mechanism for setting thresholds at national level; 3) ensure that Member States inform ECHA so as to enable the latter to make that information publicly available and 4) add a new Part D to include harmonised threshold values for the group of substances ‘sum of Trichloroethylene and Tetrachloroethylene’.

Annex III on the assessment of groundwater chemical status and Annex IV on the identification and reversal of significant and sustained upward trends are amended to take into account the new concept of ‘threshold values set at EU level’.

(3)Amendments to the Environmental Quality Standards Directive 2008/105/EC (EQSD)

The title is amended to clarify that the Directive concerns the pollution of surface waters.

Article 3 on environmental quality standards is amended to clarify the dates of application for the new and revised EQS. The obligations for monitoring in biota in paragraph 2 and for long-term trend assessments in paragraph 6 are simplified too, by clarifying their scope in the Annex. Its paragraph 7 is deleted to take into into account the proposed replacement of the co-decision procedure with that for delegated acts for changing the list of priority substances.

Article 5 on inventories of emissions is amended to simplify the reporting obligation and streamline it, where possible, with that under the EU legislation to address emissions from large industrial installations (currently under revision) and to allow for simplified reporting to the Industrial Emissions Portal, with details to be set via a future implementing act. Reporting in the framework of the River Basin Management Plans will therefore only continue to apply to diffuse emissions.

Article 7a on the coordination between various pieces of EU chemicals law is amended to include a reference to EU pharmaceuticals law, and take into into account the proposed replacement of the co-decision procedure with that for delegated acts for updating or setting new EQS.

Article 8 is amended to: 1) grant delegated powers to the European Commission to revise every six years Annex I in order to consider listing new priority substances and related EQS, based on input by ECHA; 2) grant delegated powers to the Commission to regularly revise the list of categories of river basin specific pollutants which are now included in Part B of the new Annex II (this Annex II replaces for this purpose point 1.2.6 and Annex VIII of the WFD, which will be modified accordingly to take out the river basin specific pollutants from the definition of ecological status and make them part of the regime applicable to chemical status); 3) grant delegated powers to the Commission to adopt, where necessary, EU-wide EQS for river basin specific pollutants and list these in Part C of Annex II (the proposal lists in that Part C four priority substances which were previously included in Annex I but have been ‘de-listed’ because no longer considered to be of EU wide concern); 4) clarify the central role to be played by the ECHA in devising EQS, in close cooperation with Member States and stakeholders, and its obligation to make scientific reports related to the amendment of the Annexes publicly available.

Article 8a is amended to: 1) simplify the way in which Member States may present chemical status for ubiquitous PBTs separately from the overall chemical status; 2) allow Member States to carry out less intensive monitoring for some substances; 3) require Member States to carry out effect-based monitoring to assess the presence of estrogenic hormones in water bodies, in view of possible future setting of effect-based trigger values.

Article 8b is amended to: 1) improve the monitoring and review cycle of the Watch List mechanism, setting a three year instead of the current two year cycle. This will give more time to process the data before revising the list, jointly with the proposed extension of the monitoring cycle from 12 to 24 months to allow better consideration of different frequencies for pollutants with seasonal emission patterns (e.g. pesticides/biocides); 2) allow including micro-plastics and selected antimicrobial resistance genes in the next Watch List, subject to suitable monitoring and analysis methods being identified, with input from ECHA.

The new Article 8d includes the obligation for Member States to set EQS for the river basin specific pollutants listed in Part A of the new Annex II. This replaces the obligation currently formulated in point 1.2.6 of Annex V to the WFD, in tune with the proposal to secure that river basin specific pollutants become part of assessing the chemical, rather than the ecological, status of surface water bodies. The provision also aims at ensuring that, where EU-wide EQS have been established for certain river basin specific pollutants, these shall take precedence over the EQS established at national level. Finally the amendment obliges Member States to inform ECHA to enable the latter to publicize any intention in respect of listing pollutants and/or setting EQS, to increase transparency and synergies.

Article 10 which clarifies that Annex X to the WFD is to be replaced by the text set out in Annex II to Directive 2008/105/EC, is deleted because Annex II to Directive 2008/105/EC did not exist and because Annex X is deleted further to the inclusion, in Directive 2008/105/EC, of a procedure for delegated acts for adapting the list of priority substances and setting corresponding EQS.

The title of Annex I is modified to take out the notion of ‘other pollutants’ which has become obsolete, as it referred to substances that were covered by other legislation prior to the adoption of the EQSD; there is no longer a need to distinguish between priority substances and those ‘other pollutants’. Part A, which lists the substances and their EQS, is replaced with a new Annex listing now additional 23 substances to the list of priority substances: pharmaceuticals, industrial substances, pesticides and metals. The Annex also indicates the substances that are hazardous, those that are ubiquitous PBTs as well as those that require long-term trend assessment.

A new Annex II is inserted, setting out in Part A an indicative list of river basin specific pollutants for which Member States must consider setting EQS and apply these where they are causing concern. Part B includes the general principles and refers to guidance for doing so, whereas Part C includes a repository of harmonised EQS for river basin specific pollutants. The latter will be adapted via future delegated acts through which the Commission will establish harmonised EQS for certain other river basin specific pollutants where this would prove necessary to ensure a sufficient and harmonised protection of the environment, even for pollutants which are not or not yet of EU-wide concern.