EUROPEAN COMMISSION

Brussels, 26.10.2022

COM(2022) 540 final

2022/0344(COD)

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

(Text with EEA relevance)

{SEC(2022) 540 final} - {SWD(2022) 540 final} - {SWD(2022) 543 final}

EXPLANATORY MEMORANDUM

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(4) 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:

(1)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 ;

(2)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.

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

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

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

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

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

•Consistency with other Union policies

·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

•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

•Choice of the instrument

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).

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.

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

•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 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.

•Fundamental rights

4.BUDGETARY IMPLICATIONS

5.OTHER ELEMENTS

•Implementation plans and monitoring, evaluation and reporting arrangements

•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(4) 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.

2022/0344 (COD)

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

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee 33 ,

Having regard to the opinion of the Committee of the Regions 34 ,

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1)Chemical pollution of surface and groundwater poses a threat to the aquatic environment, with effects such as acute and chronic toxicity in aquatic organisms, accumulation of pollutants in the ecosystem and loss of habitats and biodiversity, as well as to human health. Setting environmental quality standards helps to implement the zero pollution ambition for a toxic-free environment.

(2)Pursuant to Article 191(2), second sentence, of the Treaty on the Functioning of the European Union (TFEU), Union policy on the environment is to be based on the precautionary principle and on the principles that preventive action is to be taken, that environmental damage is, as a priority, to be rectified at source and that the polluter is to pay.

(3)The European Green Deal 35 is the Union’s strategy to ensure, by 2050, a climate-neutral, clean and circular economy, optimising resource management while minimising pollution. The EU Chemicals Strategy for Sustainability 36 and the Zero Pollution Action Plan 37 specifically address pollution aspects of the European Green Deal. Other particularly relevant and complementary policies include the 2018 EU Plastics Strategy 38 , the 2021 Pharmaceuticals Strategy for Europe 39 , the Biodiversity Strategy 40 , the Farm to Fork Strategy 41 , the EU Soil Strategy for 2030 42 , the EU’s Digital Strategy 43 and the EU’s Data Strategy 44 . 

(4)Directive 2000/60/EC of the European Parliament and of the Council 45  establishes a framework for the protection of inland surface waters, transitional waters, coastal waters and groundwater. That framework involves the identification of priority substances amongst those that pose a significant risk to, or via, the aquatic environment at Union level. Directive 2008/105/EC of the European Parliament and of the Council 46  lays down Union-wide environmental quality standards (EQS) for the 45 priority substances listed in Annex X to Directive 2000/60/EC and eight other pollutants that were already regulated at Union level before Annex X was introduced by Decision No 2455/2001/EC of the European Parliament and of the Council 47 . Directive 2006/118/EC of the European Parliament and of the Council 48 lays down Union-wide groundwater quality standards for nitrates and for active substances in pesticides and criteria for establishing national threshold values for other groundwater pollutants. It also sets out a minimum list of 12 pollutants and their indicators for which Member States are required to consider establishing such national threshold values. The groundwater quality standards are set out in Annex I to Directive 2006/118/EC.

(5)Substances are considered for listing in Annex X to Directive 2000/60/EC or in Annex I or Annex II to Directive 2006/118/EC based on an assessment of the risk they pose to humans and the aquatic environment. The key components of that assessment are knowledge of the environmental concentrations of the substances, including information collected from watch-list monitoring, and of the (eco)toxicology of the substances, as well as of their persistence, bioaccumulation, carcinogenicity, mutagenicity, reprotoxicity and endocrine disrupting potential.

(6)The Commission has conducted a review of the list of priority substances in Annex X to Directive 2000/60/EC in accordance with Article 16(4) of that Directive and with Article 8 of Directive 2008/105/EC, and a review of the lists of substances in Annexes I and II to Directive 2006/118/EC in accordance with Article 10 of that Directive and has concluded, in the light of new scientific knowledge, that it is appropriate to amend those lists by adding new substances, setting EQS or groundwater quality standards for those newly added substances, revising the EQS for some existing substances in line with scientific progress and setting biota EQS for some existing and newly added substances. It has also identified which additional substances are likely to accumulate in sediment or biota, and clarified that trend monitoring of such substances should be conducted in sediment or biota. The reviews of the lists of substances have been supported by an extensive consultation with experts from the Commission services, Member States, stakeholder groups and the Scientific Committee on Health, Environmental and Emerging Risks.

(7)A combination of source-control and end-of-pipe measures is required to effectively deal with most pollutants across their life cycle, including, as relevant, chemical design, authorisation or approval, control of emissions during manufacturing and use or other processes, and waste handling. The setting of new or stricter quality standards in water bodies therefore complements and is coherent with other Union legislation that addresses or could address the pollution problem at one or more of those stages, including Regulation (EC) No 1907/2006 of the European Parliament and of the Council 49 , Regulation (EC) No 1107/2009 of the European Parliament and of the Council 50 , Regulation (EU) No 528/2012 of the European Parliament and of the Council 51 , Regulation (EU) 2019/6 of the European Parliament and of the Council 52 , Directive 2001/83/EC of the European Parliament and of the Council 53 , Directive 2009/128/EC of the European Parliament and of the Council 54 , Directive 2010/75/EU of the European Parliament and of the Council 55 and Council Directive 91/271/EEC 56 .

(8)The new scientific knowledge points to a significant risk from several other pollutants found in water bodies, in addition to those already regulated.  In groundwater, a particular problem has been identified through voluntary monitoring for per- and polyfluoroalkyl substances (PFAS) and pharmaceuticals. PFAS have been detected at more than 70% of the groundwater measuring points in the Union and existing national thresholds are clearly exceeded at a considerable number of locations, and pharmaceutical substances are also widely found. In surface waters, perfluorooctane sulfonic acid and its derivatives are already listed as priority substances, but other PFAS are now also recognised to pose a risk. Watch-list monitoring under Article 8b of Directive 2008/105/EC has confirmed a risk in surface waters from a number of pharmaceutical substances which should therefore be added to the priority substances list.

(9)Directive 2000/60/EC requires Member States to identify water bodies used for the abstraction of water intended for human consumption, to monitor them, and to take the necessary measures to avoid deterioration in their quality and to reduce the level of purification treatment required in the production of water that is fit for human consumption. In this context, micro-plastics have been identified as a potential risk to human health, but more monitoring data are required to confirm the need for setting an environmental quality standard for micro-plastics in surface and groundwaters. Micro-plastics should therefore be included in the surface and groundwater watch lists and should be monitored as soon as the Commission has  identified suitable monitoring methods. In this context , account should be taken of the methodologies for monitoring and assessing the risks from micro-plastics in drinking water, developed under Directive (EU) 2020/2184 of the European Parliament and of the Council 57 .

(10)Concern has been expressed about the risk of antimicrobial resistance developing from the presence of antimicrobial resistant microorganisms and antimicrobial resistance genes in the aquatic environment, but little monitoring has taken place. Relevant antimicrobial resistance genes should also be included in the surface and ground water watch lists and monitored as soon as suitable monitoring methods have been developed. This is in line with the 'European One Health Action Plan against Antimicrobial Resistance’, adopted by the Commission in June 2017, and with the Pharmaceutical Strategy for Europe, which also addresses this concern.

(11)Considering the growing awareness of the relevance of mixtures and therefore of effect-based monitoring for determining chemical status, and considering that sufficiently robust effect-based monitoring methods already exist for estrogenic substances, Member States should apply such methods to assess the cumulative effects of estrogenic substances in surface waters over a period of at least two years. This will allow the comparison of effect-based results with the results obtained using the conventional methods for monitoring the three estrogenic substances listed in Annex I to Directive 2008/105/EC. That comparison will be used to assess whether effect-based monitoring methods may be used as reliable screening methods. Using such screening methods would have the advantage of allowing the effects of all estrogenic substances having similar effects to be covered, and not only those listed in Annex I to Directive 2008/105/EC. The definition of EQS in Directive 2000/60/EC should be modified to ensure that it may, in the future, also cover trigger values that might be set for assessing the results of effect-based monitoring.

(12)The evaluation of Union water legislation 58 (the ‘evaluation’) concluded that the process for identifying and listing pollutants affecting surface and groundwater and setting or revising quality standards for them in the light of new scientific knowledge could be accelerated. If those tasks were to be carried out by the Commission, rather than in the framework of the ordinary legislative procedure as currently provided for in Articles 16 and 17 of Directive 2000/60/EC and Article 10 of Directive 2006/118/EC, the functioning of the surface and groundwater watch-list mechanisms, in particular in terms of timing and sequence of listing, monitoring and assessing results, could be improved, the links between the watch-list mechanism and the reviews of the lists of pollutants could be strengthened, and changes to the lists of pollutants could take account of scientific progress more swiftly. Therefore, and given the need to amend the lists of pollutants and their EQS promptly in the light of new scientific and technical knowledge, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Annex I to Directive 2008/105/EC with regard to the list of priority substances and corresponding EQS set out in Part A of that Annex and to amend Annex I to Directive 2006/118/EC with regard to the list of groundwater pollutants and quality standards set out in that Annex. In this context, the Commisison should take account of the results of the monitoring of substances on the surface and groundwater watch lists. As a consequence, Articles 16 and 17 of Directive 2000/60/EC and Annex X to that Directive, as well as Article 10 of Directive 2006/118/EC, should be deleted.

(13)The evaluation also concluded that there is too much variation between Member States as regards the quality standards and threshold values set at national level for river basin specific pollutants and groundwater pollutants respectively. Until now, river basin specific pollutants not identified as priority substances under Directive 2000/60/EC have been subject to national EQS and been counted as physico-chemical quality elements supporting the assessment of ecological status in surface waters. In groundwaters, it has also been possible for Member States to set their own threshold values, even for man-made synthetic substances. This flexibility has led to sub-optimal results in terms of comparability of the status of water bodies between Member States, and in terms of environmental protection. Therefore, it is necessary to provide for a procedure that allows for an agreement at Union level on EQS and threshold values that are to be applied for those substances if they are identified as being of national concern and to establish repositories of the applicable EQS and threshold values. 

(14)Furthermore, integrating river basin specific pollutants into the definition of chemical status in surface waters ensures a more coordinated, coherent and transparent approach in terms of monitoring and assessment of chemical status of surface water bodies and of related information to the public. It also facilitates a more targeted approach to identifying and implementing measures to address all ‘chemical related’ issues in a more holistic, effective and efficient way. Therefore, the definitions of ‘ecological status’ and ‘chemical status’ should be modified and the scope of ‘chemical status’ should be widened to cover also the river basin specific pollutants, hitherto part of the definition of ‘ecological status’ in Annex V to Directive 2000/60/EC. As a result, the concept of EQS for river basin specific pollutants and related procedures should be included in Directive 2008/105/EC.

(15)In order to ensure a harmonised approach and level playing field in the Union, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Part B of Annex II to Directive 2006/118/EC by adapting the list of pollutants for which Member States have to consider establishing national threshold values.

(16)Given the need to swiftly adapt to scientific and technical knowledge and to ensure a harmonised approach and level playing field in the Union in respect of river basin specific pollutants, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to adapt Annex II to Directive 2008/105/EC with regard to the list of categories of pollutants set out in Part A of that Annex and to adapt Part C of Annex II with regard to the harmonised EQS for river basin specific pollutants or groups thereof. Those harmonised EQS should be applied by Member States in assessing the status of their surface water bodies when a risk has been identified from those pollutants.

(17)The review of the list of priority substances in Part A of Annex I to Directive 2008/105/EC has concluded that several priority substances are no longer of Union wide concern and should therefore no longer be included in Part A of Annex I to that Directive. Those substances should therefore be considered as river basin specific pollutants and included in Part C of Annex II to Directive 2008/105/EC together with their corresponding EQS. Considering that those pollutants are no longer considered to be of Union wide concern, the EQS need only be applied where those pollutants could still be of national or regional or local concern.

(18)In order to ensure a level playing field and allow comparability of water body status between Member States, there is a need to harmonise national threshold values for some groundwater pollutants. Therefore, a repository of harmonised threshold values for groundwater pollutants of national, regional or local concern should be introduced as a new Part D in Annex II to Directive 2006/118/EC. The harmonised thresholds set out in that repository need to be applied only in those Member States where the pollutants subject to those thresholds affect groundwater status. For the sum of the two synthetic pollutants trichloroethylene and tetrachloroethylene, there is a need to harmonise the national threshold values since not all Member States where the pollutants are relevant apply a threshold value for the sum of these pollutants and the national threshold values set are not all the same. The harmonised threshold value should be consistent with the parametric value set for the sum of those pollutants in drinking water under Directive (EU) 2020/2184.

(19)In order to ensure a harmonised approach and level playing field in the Union, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Part D of Annex II to Directive 2006/118/EC in order to adapt the repository of harmonised threshold values as regards the pollutants included and the harmonised threshold values to technical and scientific progress.

(20)All provisions of Directive 2006/118/EC relating to the assessment of groundwater chemical status should be adapted to the introduction of the third category of harmonised threshold values in Part D of Annex II to that Directive, in addition to the quality standards set out in Annex I to that Directive and the national threshold values set out in accordance with the methodology set out in Part A of Annex II to that Directive.

(21)To ensure effective and coherent decision-making and develop synergies with the work carried out in the framework of other Union legislation on chemicals, the European Chemicals Agency (‘ECHA’),  should be given a permanent and clearly circumscribed role in the prioritisation of substances to be included in the watch lists and in the lists of substances in Annexes I and II to Directive 2008/105/EC and Annexes I and II to Directive 2006/118/EC, and in the derivation of appropriate science-based quality standards. The Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC) of ECHA, should facilitate the carrying out of certain tasks conferred on ECHA by providing opinions. ECHA should also ensure better coordination between various pieces of environmental law through increased transparency as regards pollutants on a watch list or the development of Union wide or national EQS or thresholds, by making relevant scientific reports publicly available.  

(22)The evaluation concluded that more frequent and streamlined electronic reporting is necessary to foster better implementation and enforcement of the Union water legislation. In view of its role also to more regularly monitor the state of pollution as described in the Zero Pollution Action Plan, the European Environment Agency (EEA) should facilitate such more frequent and streamlined reporting by the Member States. It is important that environmental information on the status of Union surface water and groundwater is made available to the public and to the Commission in a timely manner. Member States should therefore be required to make available to the Commission and the EEA the monitoring data collected in the framework of Directive 2000/60/EC, making use of automated reporting and data delivery mechanisms by using Application Programming Interface or equivalent mechanisms. The administrative burden is expected to be limited insofar as Member States are already required to make publicly available spatial data themes within the scope of Directive 2007/2/EC of the European Parliament and of the Council 59  as well as under Directive (EU) 2019/1024 of the European Parliament and of the Council 60 . Those spatial data themes include the location and operation of environmental monitoring facilities, related measurements of emissions and the state of environmental media.

(23)Better integration of data flows reported to the EEA under the Union water legislation and, in particular, of the inventories of emissions required by Directive 2008/105/EC, with the data flows reported to the Industrial Emissions Portal under Directive 2010/75/EU and Regulation (EC) No 166/2006 of the European Parliament and of the Council 61 , will make the inventory reporting in accordance with Article 5 of Directive 2008/105/EC simpler and more efficient. At the same time, it will reduce administrative burden and peak work load in the preparations of the river basin management plans. In combination with the abolition of interim reporting on the progress of programmes of measures, which did not prove effective, this simplified reporting will allow Member States to put more effort into reporting emissions that are not covered by the legislation on industrial emissions but which are covered by the emissions reporting under Article 5 of Directive 2008/105/EC.  

(24)The Treaty of Lisbon introduced a distinction between powers delegated to the Commission to adopt non-legislative acts of general application to supplement or amend certain non-essential elements of a legislative act (delegated acts), and the powers conferred upon the Commission to adopt acts to ensure uniform conditions for implementing legally binding Union acts (implementing acts). Directives 2000/60/EC and 2006/118/EC should be aligned to the legal framework introduced by the Lisbon Treaty.

(25)The empowerments in Article 20(1), first subparagraph, of Directive 2000/60/EC and in point 1.4.1(ix) of Annex V to that Directive which provide for the use of the regulatory procedure with scrutiny fulfil the criteria in Article 290(1) TFEU, since they concern adaptations of the Annexes to that Directive and adoption of rules supplementing it. They should therefore be converted to empowerments for the Commission to adopt delegated acts. 

(26)The empowerment in Article 8 of Directive 2006/118/EC which provides for the use of the regulatory procedure with scrutiny fulfils the criteria in Article 290(1) TFEU, since it concerns adaptations of the Annexes to that Directive. It should therefore be converted to an empowerment for the Commission to adopt delegated acts.

(27)It is of particular importance that the Commission carry out appropriate consultations during the preparation of delegated acts, its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as the Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(28)The empowerment in Article 8(3) of Directive 2000/60/EC which provides for the use of the regulatory procedure with scrutiny fulfils the criteria in Article 290(2) TFEU, since it concerns the adoption of technical specifications and standardised methods for analysis and monitoring of water status and therefore aims at ensuringuniform conditions for the harmonised implementation of that Directive. It should therefore be converted to an empowerment for the Commission to adopt implementing acts. In order to ensure comparability of data, the empowerment should also be extended to include the establishment of formats for reporting monitoring and status data in accordance with Article 8(4). The powers conferred on the Commission should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council 62 .

(29)In order to ensure uniform conditions for the implementation of Directive 2000/60/EC, implementing powers should be conferred on the Commission to adopt technical formats for reporting monitoring and water status data in accordance with Article 8(3) of Directive 2000/60/EC. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. 

(30)In order to ensure uniform conditions for the implementation of Directive 2008/105/EC, implementing powers should be conferred on the Commission to adopt standardised formats for the reporting of point source emissions not covered by Regulation (EU) …/… of the European Parliament and of the Council 63 + , to the EEA. Those powers should be exercised in accordance with Regulation (EU) No 182/2011.

(31)It is necessary to take into account scientific and technical progress in the area of monitoring of the status of water bodies in accordance with the monitoring requirements set out in Annex V to Directive 2000/60/EC. Therefore, Member States should be allowed to use of data and services from remote sensing technologies, earth observation (Copernicus services), in-situ sensors and devices, or citizen science data, leveraging the opportunities offered by artificial intelligence, advanced data analysis and processing.  

(32)Considering the increases in unforeseeable weather events, in particular extreme floods and prolonged droughts, and in significant pollution incidentsresulting in or exacerbating transboundary accidental pollution, Member States should be required to ensure that immediate information on such incidents is provided to other potentially affected Member States and effectively cooperate with potentially affected Member States to mitigate the effects of the event or incident. It is also necessary to reinforce cooperation between Member States and streamline procedures for transboundary cooperation in case of more structural, i.e. non accidental and longer term transboundary issues which cannot be solved at Member State level, in accordance with Article 12 of Directive 2000/60/EC. In case European assistance is necessary, competent national authorities may send requests for assistance to the Emergency Response Coordination Centre of the Commission, which will coordinate possible offers of assistance and their deployment through the Union Civil Protection Mechanism, in accordance with Article 15 of Decision 1313/2013 of the European Parliament and of the Council 64 . 

(33)Directives 2000/60/EU, 2006/118/EC and 2008/105/EC should therefore be amended accordingly.

(34)Since the objectives of this Directive, namely to ensure a high level of environmental protection and an improvement of the environmental quality of European freshwaters, cannot be sufficiently achieved by Member States alone but can rather, by reason of the transboundary nature of water pollution, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives, 

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Amendments to Directive 2000/60/EC

Directive 2000/60/EC is amended as follows:

(1)in Article 1, the fourth indent is replaced by the following:

‘— achieving the objectives of relevant international agreements, including those which aim to prevent and eliminate pollution of the marine environment, by Union action to cease or phase out discharges, emissions and losses of priority hazardous substances, with the ultimate aim of achieving concentrations in the marine environment near background values for naturally occurring substances and close to zero for man-made synthetic substances.’;  

(2)Article 2 is amended as follows:

(a)point (24) is replaced by the following:

‘(24) ‘Good surface water chemical status’ means the chemical status required to meet the environmental objectives for surface waters set out in Article 4(1), point (a), of this Directive, that is the chemical status achieved by a body of surface water in which concentrations of pollutants do not exceed the environmental quality standards for priority substances listed in Part A of Annex I to Directive 2008/105/EC of the European Parliament and of the Council* and the environmental quality standards for river basin specific pollutants set in accordance with Article 8(2), point (c), and Article 8d(1) of that Directive.

(b)point (30) is replaced by the following:

‘(30) ‘Priority substances’ means substances listed in Part A of Annex I to Directive 2008/105/EC, that is substances which present a significant risk to or via the aquatic environment in a high proportion of Member States.’;

(c)the following points (30a) and (30b) are inserted:

‘(30a) ‘Priority hazardous substances’ means priority substances which are marked as ‘hazardous’ on the basis that they are recognised in scientific reports, in relevant Union legislation, or in relevant international agreements, as being toxic, persistent and liable to bio-accumulate or as giving rise to an equivalent level of concern, where this concern is relevant to the aquatic environment.

(30b) ‘River basin specific pollutants’ means pollutants that are not or no longer identified as priority substances but which Member States have identified, on the basis of the assessment of pressures and impacts on surface water bodies carried out in accordance with Annex II to this Directive, as posing a significant risk to or via the aquatic environment within their territory.’;

(d)point (35) is replaced by the following:

‘(35) ‘Environmental quality standard’ means the concentration of a particular pollutant or group of pollutants in water, sediment or biota not to be exceeded in order to protect human health and the environment or a trigger value for the adverse effect on human health or the environment of such a pollutant or group of pollutants measured using an appropriate effect-based method.’;

* Directive 2008/105/EC of the European Parliament and of the Council on the prevention and control of surface water pollution, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84).’;

(3)in Article 3, the following paragraph 4a is inserted:

‘4a. In the case of exceptional circumstances of natural origin or force majeure, in particular extreme floods and prolonged droughts, or significant pollution incidents, which could affect downstream water bodies situated in other Member States, Member States shall ensure that the competent authorities for downstream water bodies in such Member States, as well as the Commission, are immediately informed and that the necessary cooperation is set up to investigate the causes and address the consequences of the exceptional circumstances or incidents.’;

(4)Article 4(1) is amended as follows:

(a)in point (a), point (iv) is replaced by the following:

‘(iv) Member States shall implement the necessary measures to progressively reduce pollution from priority substances and river basin specific pollutants, and to cease or phase out emissions, discharges and losses of priority hazardous substances.’; 

(b)in point (b)(iii), the second subparagraph is replaced by the following:

‘Measures to achieve trend reversal shall be implemented in accordance with Article 5 of Directive 2006/118/EC and Annex IV to that Directive, subject to the application of paragraphs 6 and 7 of this Article and without prejudice to paragraph 8 of this Article.’;

(5)in Article 7, paragraph 2 is replaced by the following:

‘2. For each body of water identified under paragraph 1, in addition to meeting the objectives of Article 4 in accordance with the requirements of this Directive, for surface water bodies including the quality standards established at Union level, Member States shall ensure that under the water treatment regime applied, and in accordance with Union legislation, the resulting water will meet the requirements of Directive (EU) 2020/2184 of the European Parliament and of the Council*.  

* Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (OJ L 435, 23.12.2020, p. 1)’;

(6)Article 8 is amended as follows:

(a)paragraph 3 is replaced by the following:

‘3. The Commission is empowered to adopt implementing acts to set out technical specifications and standardised methods for analysis and monitoring of water status in accordance with Annex V and for establishing formats for reporting monitoring and status data in accordance with paragraph 4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21(2).’;  

(b)the following paragraphs 4 and 5 are added:

‘4. Member States shall ensure that the available individual monitoring data collected in accordance with point 1.3.4 of Annex V and the resulting status in accordance with Annex V are made available to the public and to the European Environment Agency (EEA) at least once a year electronically in a machine-readable format in accordance with Directive 2003/4/EC of the European Parliament and of the Council*, Directive 2007/2/EC of the European Parliament and of the Council** and Directive (EU) 2019/1024 of the European Parliament and of the Council***. For those purposes, Member States shall use the formats established in accordance with paragraph 3 of this Article.

5. The EEA shall ensure that the information made available in accordance with paragraph 4 is regularly processed and analysed for the purpose of making it available, via relevant Union portals, for reuse by the Commission and relevant Union agencies and for the purpose of providing the Commission, the Member States and the public with up-to-date, objective, reliable and comparable information, in particular on status, in accordance with Regulation (EC) No 401/2009 of the European Parliament and of the Council****.

* Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26).

** Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (OJ L 108, 25.4.2007, p. 1).

*** Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data and the re-use of public sector information (OJ L 172, 26.6.2019, p. 56).

**** Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23 April 2009 on the European Environment Agency and the European Environment Information and Observation Network (OJ L 126, 21.5.2009, p. 13).’;

(7)Article 10 is amended as follows:

(a)paragraph 2 is replaced by the following:

‘2. For the purpose of complying with the objectives, quality standards and thresholds established pursuant to this Directive, Member States shall ensure the establishment and implementation of the following:

(a) emission controls based on best available techniques;

(b) relevant emission limit values;

(c) in the case of diffuse impacts, controls including, as appropriate, best environmental practices as set out in:

–Directive 2009/128/EC of the European Parliament and of the Council*;

–Directive 2010/75/EU of the European Parliament and of the Council**;

–Council Directive 91/271/EEC***;

–Council Directive 91/676/EEC****;

–any other Union legislation relevant for addressing point source or difuse pollution.

* Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, p. 71).

** Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (OJ L 334, 17.12.2010, p. 17).

*** Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40).

**** Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources, (OJ L 375, 31.12.1991, p. 1).’;

(b)paragraph 3 is replaced by the following:

‘3. Where a quality objective, quality standard or threshold, whether established pursuant to this Directive, to Directives 2006/118/EC or 2008/105/EC, or pursuant to any other Union legislation, requires stricter conditions than those which would result from the application of paragraph 2, more stringent emission controls shall be set accordingly.’;

(8)in Article 11(3), point (k) is replaced by the following:

‘(k) measures to eliminate pollution of surface waters by priority hazardous substances and to progressively reduce pollution by other substances which would otherwise prevent Member States from achieving the environmental objectives for the bodies of surface waters set out in Article 4;’;

(9)Article 12 is replaced by the following:

‘Article 12

 Issues which cannot be dealt with at Member State level

1. Where a Member State identifies an issue which has an impact on the management of its water but cannot be resolved by that Member State, it shall notify the issue to the Commission and any other Member State concerned and make recommendations for the resolution of it.

2. The Member States concerned shall cooperate to identify the sources of the issues referred to in paragraph 1 and the measures required for addressing those issues.

Member States shall respond to each other in a timely manner, and no later than 3 months after notification by another Member State in accordance with paragraph 1.

(10)3. The Commission shall be informed of, and invited to assist in, any cooperation referred to in paragraph 2. Where appropriate, the Commission shall, taking into account the reports established pursuant to Article 13, consider whether further action needs to be taken at Union level in order to reduce the transboundary impacts on water bodies.’;

(11)in Article 15, paragraph 3 is deleted;

(12)Articles 16 and 17 are deleted;

(13)Article 18 is amended as follows:

(a)in paragraph 2, point (e) is replaced by the following:

‘(e) a summary of any proposals, control measures and strategies to control chemical pollution or cease or phase out hazardous substances;’; 

(b)paragraph 4 is deleted;  

(14)Article 20 is replaced by the following:

‘Article 20

Technical adaptations and implementation of this Directive

‘1. The Commission is empowered to adopt delegated acts in accordance with Article 20a to amend Annexes I and III and section 1.3.6 of Annex V in order to adapt the information requirements related to competent authorities, the content of the economic analysis and the selected monitoring standards, respectively, to scientific and technical progress.

2. The Commission is empowered to adopt delegated acts in accordance with Article 20a to supplement this Directive by determining the values established for the Member State monitoring system classifications in accordance with the intercalibration procedure set out in point 1.4.1 of Annex V.

3. The Commission is empowered to adopt implementing acts to set out the technical formats for the transmission of the data referred to in Article 8(4). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21(2). When establishing those formats, the Commission shall be assisted, where so required, by the EEA’;

(15)the following Article 20a is inserted:

‘Article 20a

Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 20(1) shall be conferred on the Commission for an indeterminate period of time from [OP please insert the date = the date of entry into force of this Directive].

3. The delegation of power referred to in Article 20(1) may be revoked at any time by the European Parliament and by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of the delegated acts already in force.

4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to Article 20(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’;

(16)Article 21 is replaced by the following:

‘Article 21

Committee procedure

1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council*.

2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.

* Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).’;

(17)in Article 22, paragraph 4 is replaced by the following:

 ‘4. The environmental objectives in Article 4, the environmental quality standards set out in Part A of Annex I to Directive 2008/105/EC and the thresholds for river basin specific pollutants established pursuant to Articles 8 and 8d of that Directive shall be regarded as environmental quality standards for the purposes of Directive 2010/75/EU.’;

(18)Annex V is amended in accordance with Annex I to this Directive;

(19)in Part A of Annex VII, point 7.7. is replaced by the following:

‘7.7. a summary of the measures taken to reduce the emissions of priority substances and to phase out the emissions of priority hazardous substances;’;  

(20)Annex VIII is amended in accordance with Annex II to this Directive;  

(21)Annex X is deleted.

Article 2

Amendments to Directive 2006/118/EC

Directive 2006/118/EC is amended as follows:

(1)the title is replaced by the following:

‘Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the prevention and control of groundwater pollution’;

(2)in Article 1, paragraph 1 is replaced by the following:

‘1. This Directive establishes specific measures to prevent and control groundwater pollution with the aim of achieving the environmental objectives set out in Article 4(1), point (b), of Directive 2000/60/EC. Those measures include the following:

(a) criteria for the assessment of good groundwater chemical status;

(b) criteria for the identification and reversal of significant and sustained upward trends and for the definition of starting points for trend reversals.’;

(3)in Article 2, point (2) is replaced by the following:

‘(2) ‘threshold value’ means a groundwater quality standard established by Member States in accordance with Article 3(1), point (b), or at Union level in accordance with Article 8(3);’; 

(4)Article 3 is amended as follows:

(a)in paragraph 1, first subparagraph, the following point (c) is added:

‘(c) threshold values established at Union level in accordance with Article 8(3) and listed in Part D of Annex II to this Directive.’;

(b)paragraph 2 is replaced by the following:

‘2. Threshold values referred to in paragraph 1, point (b), may be established at the national level, at the level of the river basin district or the part of the international river basin district falling within the territory of a Member State, or at the level of a body or a group of bodies of groundwater.’;

(c)paragraph 5 is replaced by the following:

‘5. All threshold values referred to in paragraph 1 shall be published in the river basin management plans to be produced under Article 13 of Directive 2000/60/EC, together with a summary of the information set out in Part C of Annex II to this Directive.

Member States shall, by [OP please insert the date = the first day of the month following 18 months after the date of entry into force of this Directive], inform the European Chemicals Agency (ECHA) of the national threshold values referred to in paragraph 1, point (b). ECHA shall make that information publicly available.’;

(d)in paragraph 6, the first subparagraph is replaced by the following:

‘Member States shall amend the list of threshold values applied in their territories whenever new information on pollutants, groups of pollutants, or indicators of pollution indicates that a threshold value needs to be set for an additional substance, that an existing threshold value needs to be modified, or that a threshold value previously removed from the list needs to be re-inserted. If relevant threshold values are established or amended at Union level, Member States shall adapt the list of threshold values applied in their territories to those values. ’;

(5)in Article 4(2), point (b) is replaced by the following:

‘(b) the values for the groundwater quality standards listed in Annex I and the threshold values referred to in Article 3(1), points (b) and (c), are not exceeded at any monitoring point in that body or group of bodies of groundwater; or’;

(6)the following Article 6a is inserted:

‘Article 6a

Watch list

1. The Commission is empowered to adopt implementing acts to establish, having regard to scientific reports prepared by ECHA, a watch list of substances for which Union-wide monitoring data are to be gathered by the Member States and to lay down the formats to be used by the Member States for reporting the results of that monitoring and related information to the Commission. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 9(2).

The watch list shall contain a maximum of five substances or groups of substances and shall indicate the monitoring matrices and the possible methods of analysis for each substance. Those monitoring matrices and methods shall not entail excessive costs for the competent authorities. The substances to be included in the watch list shall be selected from amongst those substances for which the information available indicates that they may pose a significant risk at Union level to, or via, the aquatic environment and for which monitoring data are insufficient. This watch list shall include substances of emerging concern.

As soon as suitable monitoring methods for micro-plastics and selected antimicrobial resistance genes have been identified, those substances shall be included in the watch list.

ECHA shall prepare scientific reports to assist the Commission in selecting the substances for the watch list, taking into account the following information:

(a)Annex I to Directive 2008/105/EC of the European Parliament and of the Council* and the results of the most recent review of that Annex ;

(b)the watch lists established in accordance with Directive 2008/105/EC and Directive (EU) 2020/2184 of the European Parliament and of the Council**;

(c)requirements to address soil pollution, including related monitoring data;

(d)Member States’ characterisation of river basin districts in accordance with Article 5 of Directive 2000/60/EC and the results of monitoring programmes established in accordance with Article 8 of that Directive;

(e)information on production volumes, use patterns, intrinsic properties (including mobility in soils and, where relevant, particle size), concentrations in the environment and adverse effects to human health and the aquatic environment of a particular substance or group of substances, including information gathered in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council***, Regulation (EC) No 1107/2009 of the European Parliament and of the Council****, Regulation (EU) No 528/2012 of the European Parliament and of the Council*****, Regulation (EU) 2019/6 of the European Parliament and of the Council******, Directive 2001/83/EC of the European Parliament and of the Council******* and Directive 2009/128/EC of the European Parliament and of the Council********;

(f)research projects and scientific publications, including information on trends and predictions based on modelling or other predictive assessments and data and information from remote sensing technologies, earth observation (Copernicus services), in-situ sensors and devices, or citizen science data, leveraging the opportunities offered by artificial intelligence, advanced data analysis and processing;

(g)recommendations from stakeholders.

ECHA shall every three years prepare a report summarizing the findings of the scientific reports established under the fourth subparagraph and shall make that report publicly available. The first report shall be made available by X [OP please insert the date = the first day of the twenty first month after the date of entry into force of this Directive].

2. A first watch list shall be established by .. [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Directive]. The watch list shall be updated every 36 months thereafter.

When updating the watch list, the Commission shall remove any substance or group of substances from the existing watch list, for which it considers it possible to assess its risk for the aquatic environment without additional monitoring data. When the watch list is updated, an individual substance or group of substances may be kept on the watch list for another period of three years where additional monitoring data are needed to assess the risk to the aquatic environment. The updated watch list shall also include one or more additional substances for which the Commission considers, having regard to the scientific reports of ECHA, that there could be a risk to the aquatic environment.

3. Member States shall monitor each substance or group of substances in the watch list at selected representative monitoring stations over a 24-month period. The monitoring period shall commence within six months of the establishment of the watch list.

Each Member State shall select at least one monitoring station, plus the number of stations equal to its total area in km2 of groundwater bodies divided by 60 000 (rounded to the nearest integer).

In selecting the representative monitoring stations, the monitoring frequency and the seasonal timing for each substance or group of substances, Member States shall take into account the use patterns and possible occurrence of the substance or group of substances. The frequency of monitoring shall be no less than once per year.

Where a Member State is in a position to generate sufficient, comparable, representative and recent monitoring data for a particular substance or group of substances from existing monitoring programmes or studies, it may decide not to undertake additional monitoring under the watch list mechanism for that substance or group of substances, provided that the substance or group of substances was monitored using a methodology that is compliant with the monitoring matrices and the methods of analysis referred to in the implementing act establishing the watch list.

4. Member States shall make available the results of the monitoring referred to in paragraph 3 of this Article in accordance with Article 8(4) of Directive 2000/60/EC and with the implementing act establishing the watch list as adopted pursuant to paragraph 1. They shall also make available information on the representativeness of the monitoring stations and on the monitoring strategy.

5. ECHA shall review the monitoring results at the end of the 24-month period referred to in paragraph 3 and assess which substances or groups of substances need to be monitored for another 24-month period and therefore are to be kept in the watch list and which substances or groups of substances can be removed from the watch list.

Where the Commission, having regard to the assessment by ECHA referred to in the first subparagraph, concludes that no further monitoring is required to further assess the risk to the aquatic environment, that assessment shall be taken into account in the review of Annex I or II referred to in Article 8.

* Directive 2008/105/EC of the European Parliament and of the Council on the prevention and control of surface water pollution, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84).

** Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (OJ L 435, 23.12.2020, p. 1).

*** Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (OJ L 396, 30.12.2006, p. 1).

**** Regulation (EC) No 1107/2009, of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market (OJ L 309, 24.11.2009, p. 1).

***** Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).

****** Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products (OJ L 4, 7.1.2019, p. 43).

******* Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

******** Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, p. 71).

(7)Article 8 is replaced by the following:

‘Article 8

Review of Annexes I to IV

1. The Commission shall review, for the first time by … [OP: please insert the date = six years after the date of entry into force of this Directive] and every six years thereafter, the list of pollutants set out in Annex I and the quality standards for those pollutants set out in that Annex, as well as the list of pollutants and indicators set out in Part B of Annex II.

2. The Commission is empowered to adopt delegated acts, in accordance with Article 8a, to amend Annex I to adapt it to technical and scientific progress by adding or removing groundwater pollutants and quality standards for those pollutants set out in that Annex and to amend Part B in order to adapt it to technical and scientific progress by adding pollutants or indicators for which Member States have to consider establishing national thresholds.

3. The Commission is empowered to adopt delegated acts, in accordance with Article 8a, to amend Part D of Annex II in order to adapt it to scientific and technical progress by adding or amending harmonised threshold values for one or more pollutants listed in Part B of that Annex.

4. When adopting delegated acts as referred to in paragraphs 2 and 3, the Commission shall take the scientific reports prepared by ECHA pursuant to paragraph 6 of this Article into account.

5. The Commission is empowered to adopt delegated acts in accordance with Article 8a to amend Parts A and C of Annex II and Annexes III and IV in order to adapt them to scientific and technical progress.

6. For the purpose of assisting the Commission with regard to the review of Annexes I and II, ECHA shall prepare scientific reports. Those reports shall take account of the following:

(a) the opinion of the Committee for Risk Assessment and the Committee for Socio-Economic Analysis of ECHA;

(b) the results of the monitoring programmes established in accordance with Article 8 of Directive 2000/60/EC;

(c) the monitoring data collected in accordance with Article 6a(4) of this Directive;

(d) the outcome of the reviews of the Annexes to Directive 2008/105/EC and Directive (EU) 2020/2184;

(e ) information and requirements to address soil pollution;

(f) Union research programmes and scientific publications, including information resulting from remote sensing technologies, earth observation (Copernicus services), in-situ sensors and devices and/or citizen science data, leveraging the opportunities offered by artificial intelligence, advanced data analysis and processing;

(g) comments and information from relevant stakeholders.

6. ECHA shall, every six years, prepare and make publicly available a report, summarizing the findings of the review referred to in paragraphs 2 and 3. The first report shall be submitted to the Commission on … [OP: Please insert the date = five years after the date of entry into force of this Directive].

(8)the following Article 8a is inserted:

’Article 8a

Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 8(1) and (2) shall be conferred on the Commission for an indeterminate period of time from [OP please insert the date = the date of entry into force of this Directive].

3. The delegation of power referred to in Article 8(1) and (2) may be revoked at any time by the European Parliament and the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of the delegated acts already in force.

4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Marking.

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to Article 8(1) or (2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’;

(9)Article 9 is replaced by the following:

‘Article 9

Committee procedure

1. The Commission shall be assisted by a Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council*.

2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.’; 

* Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).’; 

(10)Article 10 is deleted;

(11)Annex I is replaced by the text in Annex III to this Directive; 

(12)Annex II is amended in accordance with Annex IV to this Directive;

(13)in Annex III, point 2(c) is replaced by the following:

‘(c) any other relevant information including a comparison of the annual arithmetic mean concentration of the relevant pollutants at a monitoring point with the groundwater quality standards set out in Annex I and with the threshold values referred to in Article 3(1), points (b) and (c).’;

(14)in Annex IV, part B, point 1, the introductory sentence is replaced by the following:

‘the starting point for implementing measures to reverse significant and sustained upward trends will be when the concentration of the pollutant reaches 75 % of the parametric values of the groundwater quality standards set out in Annex I and of the threshold values referred to in Article 3(1), points (b) and (c), unless:’.

Article 3

Amendments to Directive 2008/105/EC

Directive 2008/105/EC is amended as follows:

(1)the title is replaced by the following:

’Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on the prevention and control of surface water pollution, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council’;

(2)Article 3 is amended as follows:

(a)in paragraph 1a, first subparagraph, the following point (iii) is added:

‘(iii) the substances numbered 5, 9, 13, 15, 17, 21, 23, 24, 28, 30, 34, 37, 41, 44 in Part A of Annex I, for which revised EQS are set, and the newly identified substances numbered 46 to 70 in Part A of Annex I, with effect from … [OP please insert the date = the first day of the month following 18 months after the date of entry into force of this Directive], with the aim of preventing deterioration in the chemical status of surface water bodies and of achieving good surface water chemical status in relation to those substances.’;

(b)paragraph 2 is replaced by the following:

‘2. With regard to substances for which a biota EQS or a sediment EQS is laid down in Part A of Annex I, Member States shall apply such biota EQS or sediment EQS.

With regard to substances other than those referred to in the first subparagraph, Member States shall apply the water EQS laid down in Part A of Annex I.’;  

(c)in paragraph 6, first subparagraph, the first sentence is replaced by the following:

‘Member States shall arrange for the long-term trend analysis of concentrations of those priority substances identified in Part A of Annex I as substances that tend to accumulate in sediment and/or biota, on the basis of monitoring in sediment or biota as part of the monitoring of surface water status carried out in accordance with Article 8 of Directive 2000/60/EC.’;

(d)paragraph 7 is deleted;

(e)paragraph 8 is replaced by the following:

’8. The Commission is empowered to adopt delegated acts in accordance with Article 9a to amend Part B, point 3, of Annex I in order to adapt it to scientific or technical progress.’;

(3)Article 5 is amended as follows:

(a)paragraph 1 is replaced by the following:

‘1. On the basis of the information collected in accordance with Articles 5 and 8 of Directive 2000/60/EC, and other available data, Member States shall establish an inventory, including maps, if available, of emissions, discharges and losses of all priority substances listed in Part A of Annex I to this Directive and all pollutants listed in Part A of Annex II to this Directive for each river basin district or part of a river basin district lying within their territory, including their concentrations in sediment and biota, as appropriate.

The first subparagraph shall not apply to emissions, discharges and losses reported to the Commission electronically in accordance with Regulation (EU) .../… of the European Parliament and of the Council 65+. ’;

(b)paragraphs 2 and 3 are deleted;

(c)paragraph 4 is replaced by the following:

‘4. Member States shall update their inventories as part of the reviews of the analyses specified in Article 5(2) of Directive 2000/60/EC and shall ensure that the emissions not reported to the Industrial Emissions Portal established under Regulation (EU) .../…++, are published in their river basin management plans as updated in accordance with Article 13(7) of that Directive.

The reference period for the establishment of values in the updated inventories shall be the year before the year in which the analyses referred to in the first subparagraph are to be completed.

For priority substances or pollutants covered by Regulation (EC) No 1107/2009, the entries may be calculated as the average of the three years before the completion of the analysis referred to in the first subparagraph.

For point source emissions not reported in accordance with Regulation (EU) ../… +++, because they do not fall under the scope of that Regulation or because they are below the annual reporting thresholds set out in that Regulation, the reporting obligation set out in the first subparagraph of this Article shall be fulfilled by electronic reporting to the Industrial Emissions Portal established under that Regulation.

The Commission shall, assisted by the European Environment Agency , adopt an implementing act establishing the format, level of granularity and frequency of the reporting referred to in the fourth subparagraph. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 9(2).’;

(d)paragraph 5 is deleted;

(4)In Article 7a(1), the first subparagraph is replaced by the following:

‘1. For priority substances that fall within the scope of Regulation (EC) No 1907/2006, Regulation (EC) No 1107/2009, Regulation (EU) No 528/2012, Regulation (EU) 2019/6 of the European Parliament and of the Council*, or within the scope of Directive 2001/83/EC of the European Parliament and of the Council**, Directive 2009/128/EC of the European Parliament and of the Council*** or Directive 2010/75/EU, the Commission shall, as part of the report referred to in Article 18(1) of Directive 2000/60/EC, assess whether the measures in place at Union and Member State level are sufficient to achieve the EQS for priority substances and the cessation or phasing-out objective for discharges, emissions and losses of priority hazardous substances in accordance with Article 4(1), point (a), of Directive 2000/60/EC.

* Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).

** Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

*** Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, p. 71).;

(5)Article 8 is replaced by the following:

‘Article 8

Review of Annexes I and II

‘1. The Commission shall review, for the first time by … [OP: Please insert the date = six years after the date of entry into force of this Directive] and every six years thereafter, the list of priority substances and the corresponding EQS for those substances set out in Part A of Annex I and the list of pollutants set out in Part A of Annex II.

2. The Commission is empowered to adopt delegated acts, having regard to the scientific reports prepared by the European Chemicals Agency (ECHA) pursuant to paragraph 6 of this Article, in accordance with Article 9a to amend Annex I in order to adapt it to scientific and technological progress by:

(a)    adding or removing substances from the list of priority substances;

(b)    designating or undesignating selected substances as priority hazardous substances and/or as ubiquitous Persistent Bio-accumulative and Toxic substances (uPBTs) and/or as substances that tend to accumulate in sediment and/or biota in that list;

(c)    setting corresponding EQS for surface water, sediment or biota, as appropriate.

3. The Commission is empowered to adopt delegated acts, having regard to the scientific reports prepared by ECHA pursuant to paragraph 6 of this Article, in accordance with Article 9a to amend Annex II in order to adapt it to scientific and technological progress by:

(a)adding or removing pollutants from the list of categories pollutants set out in Part A of Annex II;

(b)updating the methodology set out in Part B of Annex II;

(c)listing in Part C of Annex II to this Directive those river basin specific pollutants for which it has established that EQS set at Union level are to be applied, where relevant, to ensure a harmonised and science-based implementation of the objectives set out in Article 4 of Directive 2000/60/EC, and by listing the corresponding EQS for those pollutants in Part C of Annex II to this Directive.

4. When identifying river basin specific pollutants for which it could be necessary to set EQS at Union level, the Commission shall take into account the following criteria:

(a) the risk posed by the pollutants, including their hazard, their environmental concentrations and the concentration above which effects might be expected;

(b) the disparity between the national EQS set for river basin specific pollutants by different Member States and the degree to which such disparity is justifiable;

(c) the number of Member States already implementing an EQS for the river basin specific pollutants under consideration.

5. Priority substances which have, as a result of the review referred to in paragraph 1, been removed from the list of priority substances because they are no longer posing a Union-wide risk, shall be included in Part C of Annex II, listing the river basin specific pollutants and related harmonised EQS which are to be implemented where the pollutants are of national or regional concern, in accordance with Article 8d.

6. For the purpose of assisting the Commission with regard to the review of Annexes I and II, ECHA shall prepare scientific reports. Those scientific reports shall take account of the following:

(a) the opinions of the Committee for Risk Assessment and the Committee for Socio-Economic Analysis of ECHA;

(b) the results of the monitoring programmes established in accordance with Article 8 of Directive 2000/60/EC;

(c) the monitoring data collected in accordance with Article 8b(4) of this Directive;

(d) the outcome of the reviews of the Annexes to Directive 2006/118/EC of the European Parliament and of the Council* and Directive (EU) 2020/2184 of the European Parliament and of the Council**;

(e ) requirements to address soil pollution, including related monitoring data;

(f) Union research programmes and scientific publications, including information resulting from remote sensing technologies, earth observation (Copernicus services), in-situ sensors and devices, and/or citizen science data, leveraging the opportunities offered by artificial intelligence, advanced data analysis and processing;    

(e) comments and information from relevant stakeholders.

7. ECHA shall every six years prepare and make publicly available a report summarizing the findings of the scientific reports established under paragraph 6. The first report shall be submitted to the Commission on … [OP: Please insert the date = five years after the date of entry into force of this Directive].

* Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the prevention and control of groundwater pollution (OJ L 372, 27.12.2006, p. 19).

** Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (OJ L 435, 23.12.2020, p. 1).’;

(6)Article 8a is replaced by the following:

‘Article 8a

Specific provisions for certain substances

1. In the river basin management plans produced in accordance with Article 13 of Directive 2000/60/EC, without prejudice to the requirements of Section 1.4.3 of Annex V to that Directive regarding the presentation of the overall chemical status and the objectives and obligations laid down in Article 4(1), point (a), of that Directive, Member States may provide additional maps that present the chemical status information for one or more of the following substances separately from the information for the rest of the substances identified in Part A of Annex I to this Directive:

(a)substances identified in Part A of Annex I as substances behaving like ubiquitous PBTs;

(b)substances newly identified in the latest review in accordance with Article 8;

(c)substances for which a stricter EQS has been set in the latest review in accordance with Article 8.

Member States may present the extent of any deviation from the EQS value for the substances referred to in the first subparagraph, points (a), (b) and (c), in the river basin management plans produced in accordance with Article 13 of Directive 2000/60/EC. Member States providing additional maps as referred to in the first subparagraph shall seek to ensure their inter-comparability at river basin and Union level and shall make the data available in accordance with Directive 2003/4/EC, Directive 2007/2/EC of the European Parliament and of the Council* and Directive (EU) 2019/1024 of the European Parliament and of the Council**.

2. Member States may monitor substances identified in Part A of Annex I as substances behaving like ubiquitous PBTs less intensively than is required for priority substances in accordance with Article 3(4) of this Directive and Annex V to Directive 2000/60/EC, provided that the monitoring is representative and a statistically robust baseline is available regarding the presence of those substances in the aquatic environment. As a guideline, in accordance with Article 3(6), second subparagraph, of this Directive, monitoring should take place every three years, unless technical knowledge and expert judgment justify another interval.

3. Member States shall, from … [OP please insert the date = the first day of the month following 18 months after the date of entry into force of this Directive], for a period of two years, monitor the presence of estrogenic substances in water bodies, using effect-based monitoring methods. They shall conduct the monitoring at least four times during each of the two years at locations where the three estrogenic hormones 7-Beta estradiol (E2), Estrone (E1) and Alpha-Ethinyl estradiol (EE2) listed in Part A to Annex I to this Directive, are being monitored using conventional analytical methods in accordance with Article 8 of Directive 2000/60/EC and Annex V to that Directive. Member States may use the network of monitoring sites identified for the surveillance monitoring of representative surface water bodies in accordance with point 1.3.1 of Annex V to Directive 2000/60/EC.

* Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE), OJ L 108, 25.4.2007, p. 1).

** Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data and the re-use of public sector information, OJ L 172, 26.6.2019, p. 56).’;

(7)Article 8b is replaced by the following:

’Article 8b

Watch list

‘1. The Commission is empowered to adopt implementing acts to establish, having regard to scientific reports prepared by ECHA, a watch list of substances for which it is necessary to gather Union wide monitoring data from the Member States and to lay down the formats to be used by the Member States for reporting the results of that monitoring and related information to the Commission. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 9(2).

The watch list shall contain a maximum of 10 substances or groups of substances at any one time, and shall indicate the monitoring matrices and the possible methods of analysis for each substance. Those monitoring matrices and methods shall not entail excessive costs for the competent authorities. The substances to be included in the watch list shall be selected from amongst the substances for which the information available indicates that they may pose a significant risk at Union level to, or via, the aquatic environment and for which monitoring data are insufficient. The watch list shall include substances of emerging concern.

As soon as suitable monitoring methods for micro-plastics and selected antimicrobial resistance genes have been identified, those substances shall be included in the watch list.

ECHA shall prepare scientific reports to assist the Commission in selecting the substances for the watch list, taking into account the following information:

(a)the results of the most recent regular review of Annex I to this Directive;

(b)recommendations from the stakeholders referred to in Article 8 of Directive 2008/105/EC; 

(c)Member States’ characterisation of river basin districts in accordance with Article 5 of Directive 2000/60/EC and the results of monitoring programmes established in accordance with Article 8 of that Directive;

(d)information on production volumes, use patterns, intrinsic properties (including, where relevant, particle size), concentrations in the environment and adverse effects to human health and the aquatic environment of a substance, including information gathered in accordance with Regulation (EC) No 1907/2006, Regulation (EC) No 1107/2009, Regulation (EU) No 528/2012, Regulation (EU) 2019/6, Directive 2001/83/EC and Directive 2009/128/EC;

(e)research projects and scientific publications, including information on trends and predictions based on modelling or other predictive assessments and data and information from remote sensing technologies, earth observation (Copernicus services), in-situ sensors and devices, or citizen science data, leveraging the opportunities offered by artificial intelligence, advanced data analysis and processing.

ECHA shall every three years prepare a report summarizing the findings of the scientific reports established under the fourth subparagraph and shall make that report publicly available. The first ECHA report shall be made available by … [OP: please insert the date = first day of the twenty first month after the date of entry into force of this Directive].

2. The watch list shall be updated by X [OP please insert date = the last day of the twentythird month after the date of entry into force of this Directive], and every 36 months thereafter. When updating the watch list, the Commission shall remove any substance from the existing watch list for which it considers it possible to assess its risk for the aquatic environment without additional monitoring data. When the watch list is updated, an individual substance or group of substances may be kept on the watch list for another period of maximum three years where additional monitoring data are needed to assess the risk to the aquatic environment. Each updated watch list shall also include one or more new substances for which the Commission considers, on the basis of the scientific reports of ECHA, that there is a risk for the aquatic environment.

3. Member States shall monitor each substance or group of substances in the watch list at selected representative monitoring stations over a 24-month period. The monitoring period shall commence within six months of the inclusion of the substance in the list.

Each Member State shall select at least one monitoring station, plus one station if it has more than one million inhabitants, plus the number of stations equal to its geographical area in km2 divided by 60 000 (rounded to the nearest integer), plus the number of stations equal to its population divided by five million (rounded to the nearest integer).

In selecting the representative monitoring stations, the monitoring frequency and the seasonal timing for each substance or group of substances, Member States shall take into account the use patterns and possible occurrence of the substance or group of substances. The frequency of monitoring shall be no less than twice per year, except for substances that are sensitive to climatic or seasonal variabilities, for which the monitoring shall be carried out more frequently, as set out in the implementing act establishing the watch list adopted pursuant to paragraph 1.

Where a Member State is able to generate and provide the Commission with sufficient, comparable, representative and recent monitoring data for a particular substance or group of substances from existing monitoring programmes or studies, it may decide not to undertake additional monitoring under the watch list mechanism for that substance or group of substances, provided that the substance or group of substances was monitored using a methodology that is compliant with the monitoring matrices and the methods of analysis referred to in the implementing act establishing the watch list, as well as with Directive 2009/90/EC*.

4. Member States shall make available the results of the monitoring referred to in paragraph 3 of this Article in accordance with Article 8(4) of Directive 2000/60/EC and with the implementing act establishing the watch list adopted pursuant to paragraph 1. They shall also make available information on the representativeness of the monitoring stations and on the monitoring strategy.

5. ECHA shall review the monitoring results at the end of the 24-month period referred to in paragraph 3 and assess which substances or groups of substances need to be monitored for another 24-month period and therefore are to be kept in the watch list and which substances or groups of substances can be removed from the watch list.

Where the Commission, having regard to the assessment by ECHA referred to in the first subparagraph,, concludes that no further monitoring is required to further assess the risk to the aquatic environment, this assessment shall be taken into account in the review of Annex I or II referred to in Article 8.’

* Commission Directive 2009/90/EC of 31 July 2009 laying down, pursuant to Directive 2000/60/EC of the European Parliament and of the Council, technical specifications for chemical analysis and monitoring of water status (OJ L 201, 1.8.2009, p. 36).’;

(8)the following Article 8d is inserted:

‘Article 8d

River Basin Specific Pollutants

‘1. Member States shall set and apply EQS for the river basin specific pollutants covered by the categories listed in Part A of Annex II to this Directive, where those pollutants pose a risk to water bodies in one or more of their river basin districts based on the analyses and reviews under Article 5 of Directive 2000/60/EU, in accordance with the procedure set out in Part B of Annex II to this Directive.

Member States shall, by [OP please insert the date = the first day of the month following 18 months after the date of entry into force of this Directive], inform ECHA of the EQS referred to in the first subparagraph. ECHA shall make that information publicly available.

2. Where EQS for river basin specific pollutants have been set at Union level and listed in Part C of Annex II, in accordance with Article 8, those EQS shall take precedence over EQS for river basin specific pollutants established at national level in accordance with paragraph 1. Those EQS set at Union level shall also be applied by the Member States to establish whether the river basin specific pollutants listed in Part C of Annex II pose a risk.

3. Compliance with the applicable national EQS or EQS set at Union level, where relevant, is required for a water body to be in good chemical status, in accordance with the definition set out in Article 2(24) of Directive 2000/60/EC.’;  

(9)Article 10 is deleted;

(10)Annex I is amended in accordance with Annex V to this Directive;

(11)Annex II, as set out in Annex VI  to this Directive, is added.

Article 4

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [OP please insert the date = the first day of the month following 18 months after the date of entry into force of this Directive].

2. They shall forthwith communicate to the Commission the text of those provisions. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive

Article 5

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 6

This Directive is addressed to the Member States.

Done at Brussels,

LEGISLATIVE FINANCIAL STATEMENT for the
ZERO POLLUTION PACKAGE

FRAMEWORK OF THE PROPOSAL/INITIATIVE

Title of the proposal/initiative

Policy area(s) concerned 

The proposal/initiative relates to:

 a new action 

 a new action following a pilot project/preparatory action 66  

 the extension of an existing action 

 a merger or redirection of one or more actions towards another/a new action 

Objective(s)

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Indicators of performance

Grounds for the proposals / initiatives

Requirement(s) to be met in the short or long term including a detailed timeline for roll-out of the implementation of the initiative