(1)

On 28 July 2010, the United Nations General Assembly recognised the right to safe and clean drinking water and sanitation as a human right that is essential for the full enjoyment of life and all human rights. To fully realise that right in the Union, Member States should improve access to clean water and sanitation, in particular by improving the quality of both surface water and groundwater used for the abstraction of drinking water by implementing Directive 2000/60/EC (3), and through the effective implementation of Directives (EU) 2020/2184 (4) and (EU) 2024/3019 (5) of the European Parliament and of the Council.

(2)

Chemical pollution of surface water 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.

(3)

According to the European Environment Agency’s report entitled ‘Europe’s state of water 2024’, in 2021 Member States reported that around 90 % of the area of groundwater bodies was in good quantitative status, and around 75 % was in good chemical status, while 40 % of surface water bodies were in good or high ecological status, and 38 % in good chemical status. As outlined in the Commission’s 7th Implementation Report (2024), assessing the third river basin management plans, the reasons for this are manifold. As regards chemical status, some positive trends are masked by historic, widespread contamination by mercury and other ubiquitous, bioaccumulative and toxic pollutants or are overshadowed by new, emerging pollution challenges. As regards ecological status, there has been some improvement in certain biological quality elements. However, rivers, lakes and coastal waters in the Union are still subject to significant pressures and, even when effective measures are taken, progress may not be visible over the short term in the monitoring results because nature needs sufficient time to recover.

(4)

Overall, the conclusions of the 2019 Fitness Check of Directives 2000/60/EC, 2006/118/EC (6), 2007/60/EC (7) and 2008/105/EC (8) of the European Parliament and of the Council (the ‘Fitness Check’) indicate that those Directives are broadly fit for purpose, with some scope for improvement. The conclusions indicate that those Directives have so far generally led to a higher level of protection of water bodies and better flood risk management. However, they also point out that currently more than half of all European water bodies are subject to exemptions under Directive 2000/60/EC, which indicates that Member States face a very substantial challenge to achieve the objective of good water status, and in particular to comply with the environmental quality standards (EQS) for priority substances, within the given deadlines. In addition, the Fitness Check concluded that the slow progress made as regards achieving the objectives of those Directives can, amongst other things, be attributed to slow implementation, in part due to a lack of sufficient financial resources as well as insufficient integration of environmental objectives into sectoral legislation.

(5)

As reported in the Commission assessment of 4 February 2025 on the implementation of Directive 2000/60/EC based on the Member States’ third river basin management plans, the Union’s water resources remain under severe pressure due to structural mismanagement, unsustainable land use, hydro-morphological changes, pollution, climate change, increased demand for water and urbanisation. The most significant pressures on surface water bodies in all reporting Member States are, in descending order of the percentage of water bodies affected: pollution from atmospheric deposition, hydro-morphological changes stemming from drainage and irrigation for agriculture, hydropower, flood protection, navigation or drinking water supply, and pollution from agriculture. Similarly, the biggest pressures on groundwater bodies are, first, diffuse agricultural pollution, for example from the use of pesticides and fertilisers, and second, in descending order, abstraction for public water supply, for agriculture, for industrial use and for other purposes. Addressing those combined pressures is essential to ensure the sustainable management and protection of water bodies. This requires integrated approaches that promote the reduction of pollution at source and the remediation of existing pollution, the restoration of ecosystems, the adoption of efficient water-use technologies, and the implementation of sustainable practices across sectors. Member States should strengthen the coordination between water and sectorial policies to reduce negative impacts on water resources and support the achievement of good ecological, quantitative and chemical status as set out in Directive 2000/60/EC.

(6)

Pursuant to Article 191(2) 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.

(7)

In seeking to achieve a high level of environmental protection and in implementing the Zero Pollution Action Plan set out in the communication of the Commission of 12 May 2021 on the Pathway to a Healthy Planet for All – EU Action Plan: ‘Towards Zero Pollution for Air, Water and Soil’, the Union should take account of the diversity of situations in the different regions of the Union, the impact on food security, food production and food affordability, as well as healthy and sustainable diets.

(8)

The Commission’s communication of 11 December 2019 on the European Green Deal sets out a strategy to ensure, by 2050, a climate-neutral, clean and circular economy, optimising resource management while minimising pollution. The communication of the Commission of 14 October 2020 on the Chemicals Strategy for Sustainability Towards a Toxic-Free Environment and the Zero Pollution Action Plan specifically address pollution aspects of the European Green Deal. Other particularly relevant and complementary policies are set out in the communications of the Commission of 16 January 2018 on a European Strategy for Plastics in a Circular Economy, of 19 February 2020 on Shaping Europe’s digital future, of 19 February 2020 on a European strategy for data, of 20 May 2020 on a Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system, of 20 May 2020 on the EU Biodiversity Strategy for 2030 Bringing nature back into our lives, of 25 November 2020 on the Pharmaceutical Strategy for Europe, of 17 November 2021 on the EU Soil Strategy for 2030 Reaping the benefits of healthy soils for people, food, nature and climate and of 4 June 2025 on the European Water Resilience Strategy.

(9)

The objectives of achieving ‘good status of water bodies’ and of ensuring water availability are cross-cutting and are often not pursued in a sufficiently coherent way. Sustainable water management should be mainstreamed across all Union policies concerning water-using sectors.

(10)

Directive 2000/60/EC 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 lays down Union-wide EQS for the 45 priority substances previously listed in Annex X to Directive 2000/60/EC and eight other pollutants that were already regulated at Union level before that Annex was introduced by Decision No 2455/2001/EC of the European Parliament and of the Council (9). Directive 2006/118/EC 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 indicators of pollution 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.

(11)

It should be ensured that the discharges, emissions and losses of priority hazardous substances cease or are phased out within an appropriate timeline and, in any case, not later than 20 years after a given priority substance is listed as hazardous in Part A of Annex I to Directive 2008/105/EC. That timeline should apply without prejudice to the application of stricter timelines in any other applicable Union legislation.

(12)

Substances are considered for listing in Part A of Annex I to Directive 2008/105/EC or in Annex I or Part B of 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 the (eco)toxicity of the substances, as well as their persistence, bioaccumulation, mobility, carcinogenicity, mutagenicity, reprotoxicity and endocrine-disrupting potential.

(13)

The Commission has conducted a review of the list of priority substances previously in Annex X to Directive 2000/60/EC in accordance with Article 16 thereof and with Article 8 of Directive 2008/105/EC, and a review of the lists of substances in Annex I and Part B of Annex II to Directive 2006/118/EC in accordance with Article 10 thereof 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 or sediment EQS for some existing and newly added substances. The Commission 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.

(14)

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 Directive 2001/83/EC of the European Parliament and of the Council (10), Regulations (EC) No 1907/2006 (11) and (EC) No 1107/2009 (12) of the European Parliament and of the Council, Directives 2009/128/EC (13) and 2010/75/EU (14) of the European Parliament and of the Council, Regulations (EU) No 528/2012 (15) and (EU) 2019/6 (16) of the European Parliament and of the Council and Directive (EU) 2024/3019. In order to achieve the environmental objectives laid down in Article 4 of Directive 2000/60/EC in the most cost-effective way possible, the Commission and the Member States should prioritise, where possible, in their actions and programmes of measures, respectively, source-control measures, as well as their enforcement. Coherence between all pieces of Union and national legislation addressing pollutant emissions at source should be ensured in order to reduce pollution to levels no longer considered harmful to health and natural ecosystems.

(15)

New scientific evidence 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 threshold values are clearly exceeded at a considerable number of locations. A subset of specific PFAS should therefore be added to the list of groundwater pollutants. In surface waters, perfluorooctane sulfonic acid (PFOS) and its derivatives are already listed as priority substances, but other PFAS are now also recognised as posing a risk. A subset of specific PFAS should therefore be added to the list of priority substances. Voluntary monitoring in groundwater and watch-list monitoring under Article 8b of Directive 2008/105/EC have also confirmed a risk in groundwaters and surface waters from a number of pharmaceutical substances which should therefore be added, as relevant, to the list of pollutants in Annex I to Directive 2006/118/EC or to the priority substances list in Annex I to Directive 2008/105/EC. In groundwater, the Commission should consider addressing the cumulative risk from pharmaceuticals, by setting quality standards for the sum(s) of selected pharmaceuticals, potentially based on mode of action, at the next review. For that reason, ‘sum(s) of selected pharmaceuticals by mode of action’ should be added to Annex V to Directive 2006/118/EC. In surface water, the cumulative risk from estrogenic pharmaceuticals should be addressed by effect-based monitoring and, taking into account data from more recent and ongoing watch-list monitoring, the Commission should consider setting standards for the sum(s) of selected pharmaceuticals, potentially based on mode of action, at the next review; for that reason ‘sum(s) of selected pharmaceuticals by mode of action’ should be added to Annex III to Directive 2008/105/EC. The Commission should also consider setting standards for total pharmaceuticals, supported by appropriate monitoring methods. Member States are encouraged to monitor also the totality of PFAS (‘PFAS Total’) in groundwater using the guidance adopted under Article 13(7) of Directive (EU) 2020/2184. The Commission should consider the guidance and the results obtained by Member States in defining a monitoring method for PFAS Total specifically in groundwater and encourage Member States to apply it. The Commission should adapt that monitoring method to facilitate the monitoring of PFAS Total in surface water and encourage the Member States to apply it. The Commission should also consider setting quality standards for PFAS Total in groundwater and surface waters during the next review of the lists of pollutants set out in Annex I to Directives 2006/118/EC and Annex I to Directive 2008/105/EC.

(16)

Bisphenol-A should be added to the list of substances in Annex I to Directive 2008/105/EC and designated as a priority hazardous substance. Scientific evidence shows that bisphenols other than Bisphenol-A have endocrine-disrupting potential, and thus that replacing the use of one by the use of another might not have the intended benefit. Further, mixtures of bisphenols could pose a cumulative risk. The Commission should therefore review the listing of bisphenols in general at the next review, and consider the establishment of an EQS for the totality of bisphenols (‘Bisphenols Total’) or at least for the sum of selected bisphenols (‘Sum of Bisphenols’), including at least Bisphenol-B and Bisphenol-S, supported by appropriate monitoring methods. The ‘Sum of Bisphenols’ should therefore be listed in Annex III to Directive 2008/105/EC. Furthermore, Member States should give particular consideration to whether to identify and monitor at least Bisphenol B and Bisphenol S as river basin specific pollutants, where potentially relevant, and to reporting the data in accordance with Article 8(4) of Directive 2000/60/EC to ensure that the risk from the sum of those bisphenols and Bisphenol A can be properly assessed at the next review. The Commission should also consider establishing quality standards for ‘Bisphenols Total’ and ‘Sum of Bisphenols’ in Directive 2006/118/EC.

(17)

Taking into account that groundwater is the main source of drinking water in the Union, it is essential to ensure that the quality standards set in Directive 2006/118/EC support the achievement of the parametric values set for drinking water under Directive (EU) 2020/2184. Although it might be appropriate to harmonise the standards for PFAS, it has recently been demonstrated that the parametric value relating to the sum of the 20 PFAS, as listed in Part B, point 3, of Annex III to Directive (EU) 2020/2184, is not in line with the latest scientific developments with respect to the list of PFAS to be given priority consideration, the toxicity of these substances and the variability of toxicity between the substances in this family. In the absence of a complete and final agreement on PFAS standards, a quality standard for the group of 20 PFAS, as listed in Part B, point 3, of Annex III to Directive (EU) 2020/2184, is set out in Annex I of Directive 2006/118/EC, by way of reference to the parametric value for that group in Directive (EU) 2020/2184 in order to ensure that any change to the composition of that group or that value be automatically incorporated into Directive 2006/118/EC. To take account of the most recent scientific knowledge, a quality standard for the sum of the four most problematic PFAS should be added to Annex I to Directive 2006/118/EC in accordance with the value proposed by the European Food Safety Authority (EFSA). For the same reason, it is of utmost importance that the parametric values for PFAS in Directive (EU) 2020/2184 be promptly reviewed and revised as appropriate and, in such a case that the quality standards in Annex I to Directive 2006/118/EC also be aligned.

(18)

Considering the toxicity of trifluoroacetic acid (TFA), its persistence and prevalence in the environment, and its many sources, including the use of PFAS pesticides and fluorine-containing refrigerant gases, it is extremely important to address its presence in both surface water and groundwater. For surface water, TFA should therefore be included in a sum of 25 PFAS with an EQS in Annex I to Directive 2008/105/EC. At the next review, the Commission should consider establishing a separate EQS for TFA in Annex I to Directive 2008/105/EC. For groundwater, the Commission should also consider establishing a quality standard for TFA, whether separate or as a part of a sum, in Annex I to Directive 2006/118/EC, taking into account the most recent scientific knowledge on TFA, including work carried out by the European Chemicals Agency (ECHA), EFSA and the World Health Organization (WHO). Future amendments of Directive (EU) 2020/2184 should also be taken into account.

(19)

There is a need to gather more knowledge about the presence, importance and sensitivity of groundwater ecosystems in order to properly protect them. Additional scientific research should therefore be encouraged, funded and conducted, and the findings should be disseminated, and, where necessary, taken into account, along with existing knowledge, when implementing or revising Directives 2000/60/EC and 2006/118/EC. The Commission should work with Member States under the Common Implementation Strategy for Directive 2000/60/EC to establish a methodology for identifying groundwater ecosystems. As soon as a reliable methodology is available, Member States should, where relevant, apply that methodology, and set stricter standards where necessary to protect those ecosystems.

(20)

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 that 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 quality standards for micro-plastics in surface water and groundwater. Micro-plastics should therefore be included in the surface water and groundwater watch lists and should be monitored as soon as suitable monitoring methods are available. In that context, account should be taken of the methodologies, developed under Directive (EU) 2020/2184, for monitoring and assessing the risks from micro-plastics in drinking water.

(21)

It is estimated that in 2019, between 900 000 and 1,7 million deaths around the world were attributable to antimicrobial resistance (AMR) infections. At the same time, 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. Appropriate indicators for the presence, evolution or transmission of antimicrobial resistance should also be included in the surface water and groundwater 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 Commission communication of 25 November 2020 entitled ‘Pharmaceutical Strategy for Europe’, which also addresses that concern.

(22)

Directives 2006/118/EC and 2008/105/EC should each contain an annex listing selected substances, groups of substances, and indicators to be considered by the Commission in the next review of those Directives, pending development of reliable monitoring methodologies and appropriate quality standards or trigger values and final confirmation that they pose a risk to or via groundwater or surface water. That confirmation could, if necessary, be obtained by including the substances, groups of substances, or indicators in the relevant watch list.

(23)

The conventional chemical analytical methods used for monitoring substances under Directives 2000/60/EC, 2006/118/EC and 2008/105/EC cannot, in general, determine the cumulative risk from mixtures of substances. 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 effect-based monitoring 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 pharmaceutical substances listed in Annex I to Directive 2008/105/EC. For that purpose, the Commission should adopt an implementing act setting out the technical specifications for the monitoring of estrogenic substances using effect-based monitoring methods. The Commission should also publish a report on the comparison of effect-based results with the results obtained using the conventional methods, and an analysis of it should be used to assess whether effect-based monitoring methods deliver data that are robust and accurate enough to allow those methods to 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, not only those listed in Annex I to Directive 2008/105/EC, and could also replace substance-by-substance monitoring at many locations. The concept of effect-based trigger values should be defined. The definition of good surface water chemical status in Directive 2000/60/EC should be modified to ensure that it could, in the future, also cover trigger values that might be set for assessing the results of effect-based monitoring.

(24)

Whereas the risk from mixtures of pesticides is to some degree covered in Directive 2006/118/EC by the quality standard for total pesticides, the risk from such mixtures is not addressed in Directive 2008/105/EC. To at least partly address that cumulative risk, an EQS should therefore be set for the sum of the pesticides that are already included in the list of priority substances that are to be monitored in water, and that EQS should be taken into account when assessing chemical status. To take better account of mixture risk in the future, the Commission should consider setting standards for the sum(s) of selected pesticides, potentially based on mode of action and possibly covering more pesticides than those listed individually in Annex I to Directive 2008/105/EC, at the next review. For that reason, the ‘sum(s) of selected pesticides by mode of action’ should be included in a new annex to that Directive. The Commission should also consider whether a risk-based approach could be taken to establishing an EQS for total pesticides, supported by an appropriate monitoring method. Because the generic quality standards of 0,1 μg/L and 0,5 μg/L for individual and total pesticides in groundwater specified in Annex I to Directive 2006/118/EC were established in the 1980s, and limited by the sensitivity of the analytical methods available at that time, they may not be sufficiently protective of human health or the environment. The Commission should therefore review those values at the next review of the list of pollutants in groundwater.

(25)

As a result of its review of the list of substances in Part A of Annex I to Directive 2008/105/EC, the Commission identified a number of substances that it could remove from the list because they no longer pose a widespread risk to or via the aquatic environment within the Union. However, because those substances still pose a risk in some Member States, it is appropriate to include them, with their EQS, in a new annex to Directive 2008/105/EC. Member States should continue to monitor those substances if they identify them as pollutants of national, regional or local concern, and to apply the EQS accordingly. Some other substances were considered for deselection but have been retained in the list because of the need to determine whether their concentrations are showing a downward trend. For some of them, monitoring under Directives 2000/60/EC and 2008/105/EC also contributes to fulfilling monitoring obligations under the Stockholm Convention on persistent organic pollutants (17) (‘Stockholm Convention’), signed in Stockholm on 22 May 2001, and Regulation (EU) 2019/1021 of the European Parliament and of the Council (18).

(26)

In accordance with the Stockholm Convention and Regulation (EU) 2019/1021, Member States are obliged to ensure the protection of human health and the environment from persistent organic pollutants. Member States are required to monitor the presence of persistent organic pollutants in the environment in accordance with Article 13(1), point (d), of Regulation (EU) 2019/1021 implementing the requirements of Article 11(1) of the Stockholm Convention.

(27)

Until now, river basin specific pollutants that are 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. That 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 threshold values in Annex II to Directive 2006/118/EC and of the applicable EQS in a new annex to Directive 2008/105/EC. The harmonised EQS and threshold values should only be applied by Member States in assessing the status of their water bodies in the river basin districts where a risk has been identified from those substances.

(28)

Furthermore, integrating river basin specific pollutants into the definition of chemical status of 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. The status of a water body should not be considered as having deteriorated merely because of that change.

(29)

The surface water and groundwater watch list mechanisms aim to gather information on the presence and distribution of substances of potential concern in the aquatic environment, which, to date, have been poorly documented and for which there are often no standardised analytical methods available. In addition, for substances listed in Annex I to Directive 2006/118/EC and in Annex I to Directive 2008/105/EC, the analytical methods available on the market are not always sensitive enough to achieve the proposed quality standards. Developing new methods and monitoring an increased number of substances, groups of substances, or indicators is challenging and generates increased costs but also a need for strengthened administrative capacity in the Member States, especially those with fewer resources. Therefore, the establishment of a joint monitoring facility for managing the monitoring requirements, when so requested by the Member States, could help them in carrying out that challenging task, easing their financial and administrative burdens. The Commission should assess the options for the establishment, financing and functioning of such a monitoring facility. The use of such a facility should be voluntary, accessible to all interested Member States and without prejudice to arrangements already in place at national level.

(30)

Several judgments of the Court of Justice of the European Union have clarified the concept of deterioration of status. A definition of deterioration of status should therefore be introduced into Directive 2000/60/EC. As referred to in Annex V to that Directive, the status of a surface water body comprises both its ecological and chemical status and the status of a groundwater body comprises both its quantitative and chemical status. Instead of referring to each of those elements separately in the definition, reference should be made simply to Annex V to that Directive. If the status of a quality element for surface water assessed as ‘bad’ or ‘failing to achieve good’ or the status of a quality element for groundwater assessed as ‘poor’ deteriorates further, that deterioration should also be considered as a deterioration of the status of the water body.

(31)

The judgments of the Court of Justice of the European Union, combined with additions to the lists of substances as well as stricter standards for existing pollutants, have rendered the application of the non-deterioration principle of Directive 2000/60/EC more challenging, in particular for projects that have a negative short-term impact on water bodies or projects and activities that have a negative impact on water bodies due to relocation of water or sediments containing pollutants. In the case of projects causing a negative short-term impact on one or more quality elements of a water body, it is essential to confirm that the negative impact on those quality elements is no longer detectable after one year or, for biological quality elements, after a maximum of three years. To ascertain that the negative impact is no longer present, it should be possible for Member States to use existing monitoring arrangements. However, such arrangements might not be sufficient, for instance where status is usually determined by extrapolation, or if the affected quality elements are different from those considered most sensitive to routine pressures and impacts, and thus not regularly monitored. In those cases, the ex-post verification should be done through supplementary and tailored monitoring. In the case of projects or activities having a negative impact on water bodies due to relocation of polluted water or sediments, the pollutant concentrations in the source-water body might decrease and those in the receiving water body might increase despite there being no overall change in pollutant mass balance. Such activities include the discharge of contaminated drainage water from construction works or the relocation of dredged sediments for flood protection or navigation and should be allowed, provided that several criteria are met. Those criteria should include a requirement that all practicable steps, including treatment, be taken to mitigate any adverse impact and that the receiving surface water body is already in less-than-good chemical status with respect to most of the substances relocated, and in particular with respect to the most persistent and bioaccumulative substances, such as PFAS, and that information relating to the criteria, and reasons for the relocation, are provided in the relevant river basin management plan. The criteria are intended to ensure that the overall level of protection of human health and the environment provided by Directive 2000/60/EC is maintained. The relocation of polluted water or sediment should not detract from the quality of drinking water resources, and a zone should therefore be established adjacent to any drinking water abstraction point where stricter precautions are needed. If Member States have already established safeguard zones under Article 7 of Directive 2000/60/EC, or Article 8 of Directive (EU) 2020/2184, those zones might serve the purpose.

(32)

The green transition and other activities of public interest, such as in the areas of security and defence, require significant investments in and development of new technologies, which can be challenging to reconcile with the objectives of Directive 2000/60/EC, for example if they require the mining and use of critical raw materials which result in emissions of substances of emerging concern. It is important to assess potential risks to the environment or human health from those substances. This should be taken into account when listing substances on the watch lists. It is equally important to identify the potential conflicts between those overall objectives and develop appropriate responses to them. This could be done as part of the implementation report drawn up by the Commission in accordance with Article 18 of Directive 2000/60/EC.

(33)

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 Parts A and C of Annex II and Annexes III and IV to Directive 2006/118/EC concerning guidelines for the establishment of threshold values by Member States, information to be provided by Member States with regard to the pollutants and indicators of pollution for which threshold values have been established, the assessment of groundwater chemical status and the identification and reversal of significant and sustained upward trends.

(34)

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 the procedure on how to derive EQS for river basin specific pollutants, 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 2008/105/EC.

(35)

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 that Annex. Those substances should therefore be considered as river basin specific pollutants and included in a new annex to Directive 2008/105/EC together with their corresponding EQS.

(36)

In order to ensure a level playing field in the Union and allow comparability of water body status between Member States, there is a need to harmonise national threshold values for some man-made synthetic groundwater pollutants. Threshold values should be established as necessary at Union level for pollutants which have an anthropogenic origin or for the products of their degradation or decomposition, provided that those pollutants and degradation products either do not occur naturally in groundwater, or, if identical natural counterparts exist, provided that their natural background levels are, at most, low. Those threshold values should be included in the repository of harmonised threshold values for man-made synthetic substances in groundwater of national, regional or local concern in a new Part D of Annex II to Directive 2006/118/EC. A harmonised threshold value for individual pharmaceuticals should be included for application by Member States to any pharmaceutical active substance identified as posing a risk at national level unless a stricter standard or threshold value has been set specifically for that substance at Union or national level.

(37)

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 a new 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.

(38)

To ensure effective and coherent decision-making and develop synergies with the work carried out in the framework of other Union legislation on chemicals, 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 threshold values, by making relevant scientific reports publicly available. When deriving threshold values for pharmaceutical substances, ECHA should liaise with the European Medicines Agency (EMA).

(39)

The Fitness Check concluded that more frequent and streamlined electronic reporting is needed to foster better implementation and enforcement of 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 of monitoring data by Member States. It is important that this essential environmental information be made available to the public and to the Commission in a timely manner. Without prejudice to the monitoring frequency obligations in Directives 2000/60/EC, 2006/118/EC and 2008/105/EC, and insofar as the monitoring obligations under those Directives have led to the generation of new monitoring data, Member States should make the following data available to the public and to the EEA: (i) every three years, monitoring data on biological quality elements in surface waters collected and validated during the preceding three years; and (ii) every two years, monitoring data on chemical quality elements in surface water and groundwater collected and validated during the preceding two years. This should take place through the existing electronic data delivery mechanisms, such as the EEA’s Reportnet system, with data submission facilitated by automation, aligned with the relevant Water Information System for Europe State of the Environment data flows. Member States are encouraged to make available to the public and to the EEA the monitoring data on chemical quality elements annually. The reporting of status will continue to take place in the six-yearly river basin management plans. The administrative burden is expected to be limited insofar as Member States are already required to make spatial data themes publicly available under Directive 2007/2/EC of the European Parliament and of the Council (19) as well as under Directive (EU) 2019/1024 of the European Parliament and of the Council (20).

(40)

The status assessment under Directive 2000/60/EC is based on the one-out-all-out-principle and it should remain so. It is therefore important that Member States take all possible measures to achieve good status or potential, as appropriate, in relation to each relevant individual quality element. At the same time, to ensure that progress or lack thereof on individual quality elements is visible, even when not all of them reach good status or potential, and that progress or lack thereof across the Member States can be compared, indicators of progress should be developed and harmonised at Union level for the uniform presentation and reporting by Member States of the status or potential of those individual quality elements in a disaggregated way. Those indicators of progress should be interpreted without prejudice to the conclusions drawn from applying the one-out-all-out principle.

(41)

Better integration of data flows reported to the EEA under 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 (EU) 2024/1244 of the European Parliament and of the Council (21), 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 workload in the preparation of the river basin management plans. In combination with the abolition of interim reporting on progress on the implementation of programmes of measures, which did not prove effective, this simplified reporting will allow Member States to put more effort into reporting emissions which until recently were not covered by the legislation on industrial emissions although they were covered by the emissions reporting under Article 5 of Directive 2008/105/EC.

(42)

The Treaty of Lisbon amending the Treaty on European Union and the Treaty establishing the European Community (22), signed at Lisbon on 13 December 2007, introduced a distinction between powers delegated to the Commission to adopt delegated acts, that is non-legislative acts of general application to supplement or amend certain non-essential elements of a legislative act, and the powers conferred upon the Commission to adopt implementing acts, that is acts to ensure uniform conditions for implementing legally binding Union acts. Directives 2000/60/EC and 2006/118/EC should be aligned to the legal framework introduced by that Treaty.

(43)

The empowerment in Article 20(1), first subparagraph, of Directive 2000/60/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 and adoption of rules supplementing it. It should therefore be converted to an empowerment for the Commission to adopt delegated acts. The empowerment in Section 1.4.1(ix) of Annex V to Directive 2000/60/EC, which provides for the use of the regulatory procedure with scrutiny, fulfils the criteria in Article 291(2) TFEU since it concerns uniform conditions for implementing that Directive. It should therefore be converted to an empowerment for the Commission to adopt implementing acts.

(44)

The empowerment in Article 8(1) 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 Parts A and C of Annex II and Annexes III and IV to that Directive. It should therefore be converted to an empowerment for the Commission to adopt delegated acts.

(45)

It is of particular importance that the Commission carry out appropriate consultations during its preparatory work on delegated acts, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (23). 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.

(46)

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 291(2) TFEU, since it concerns the adoption of technical specifications and standardised methods for analysis and monitoring of water status and therefore aims at ensuring uniform 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) of Directive 2000/60/EC. The implementing powers conferred on the Commission should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (24).

(47)

Member States’ experts should continue to be involved in the regular cooperation facilitated by the Common Implementation Strategy for Directive 2000/60/EC and in particular in the working groups established under it, and thus closely involved especially in the revision of the watch lists, the updates of the lists of pollutants and the establishment of the reporting formats.

(48)

In order to ensure uniform conditions for the implementation of Directive 2000/60/EC, implementing powers should be conferred on the Commission to set out technical specifications and standardised methods for analysis and monitoring of water status in accordance with Annex V to that Directive, to establish formats for the reporting of monitoring and status data, to adopt the results of the intercalibration exercise and the values established for the Member State monitoring system classifications in accordance with Section 1.4.1(ix) of Annex V to that Directive and to adopt indicators of progress allowing comparison of the progress made by Member States towards achieving the good status or potential of their water bodies. Those powers should be exercised in accordance with Regulation (EU) No 182/2011.

(49)

In order to ensure uniform conditions for the implementation of Directive 2006/118/EC, implementing powers should be conferred on the Commission to adopt a groundwater watch list and to establish a list of relevant and non-relevant metabolites of pesticide substances. Those powers should be exercised in accordance with Regulation (EU) No 182/2011.

(50)

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) 2024/1244 and of diffuse emissions to the EEA. Those powers should be exercised in accordance with Regulation (EU) No 182/2011.

(51)

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 data and services from remote sensing technologies, earth observation, such as Copernicus services, in situ sensors and devices, online water-quality monitoring systems, or citizen science data, leveraging the opportunities offered by artificial intelligence, advanced data analysis and processing. In accordance with the EU Digital Strategy, including its objectives for increased digitalisation of public services and businesses, Member States are encouraged to tap the potential of digitalisation for water management and in particular for water quality monitoring. It is important to assess the technical and economic feasibility of using online systems for the continuous, precise and real-time monitoring of water quality, and develop, if appropriate, guidance on their application. This could be done in the context of the Common Implementation Strategy for Directive 2000/60/EC, with the aim of assisting Member States to digitalise, where possible and appropriate, their water quality monitoring techniques. Member States that have taken measures to digitalise monitoring techniques are encouraged to include a summary of those measures in their river basin management plans.

(52)

Member States should encourage deployment of digital tools such as remote sensing technologies and earth observation, such as Copernicus services.

(53)

The competent authorities should support training, skills development programmes and investment in human capital to support the effective implementation of the best technologies and innovative solutions within the framework of Directive 2000/60/EC.

(54)

In accordance with the Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters (25), signed in Aarhus on 25 June 1998, members of the public concerned are to have access to justice in order to contribute to the protection of the right to live in an environment which is adequate for personal health and well-being. Therefore Member States should ensure access to justice under Directive 2000/60/EC in accordance with that Convention. Moreover, according to settled case law of the Court of Justice of the European Union, it is for the courts of the Member States to ensure judicial protection of a person’s rights under Union law. Furthermore, Article 19(1) of the Treaty on European Union (TEU) requires Member States to provide remedies sufficient to ensure effective judicial protection in the fields covered by Union law.

(55)

Considering the increases in unforeseeable weather events, in particular extreme floods and prolonged droughts, and in significant pollution incidents resulting in or exacerbating transboundary accidental pollution, Member States should be required to ensure that information on such incidents is provided without delay to other potentially affected Member States and effectively cooperate with such 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 the 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. Where Member States have already established effective cooperation, this should be taken into account. If Union assistance is necessary, competent national authorities can send requests for assistance to the Emergency Response Coordination Centre of the Commission, which will facilitate the coordination of the provision of the required assistance through the Union Civil Protection Mechanism, in accordance with Article 15 of Decision No 1313/2013/EU of the European Parliament and of the Council (26). Moreover, considering that river basin districts can also extend beyond the territory of the Union, it is important to ensure that Member States effectively implement Directive 2000/60/EC within their respective territories. Member States should also endeavour to establish appropriate coordination with the relevant third countries which would contribute to the fulfilment of the objectives set out in that Directive for those specific river basin districts.

(56)

The Commission should report on the possibility of including an extended producer responsibility mechanism in Directive 2000/60/EC. That report should take into account experience gained in particular from implementing the provisions concerning extended producer responsibility in the Union legislation on urban waste-water treatment, waste, and single-use plastics.

(57)

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

(58)

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 TEU. 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,

(1)

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

;

(2)

Article 2 is amended as follows:

(3)

Article 4 is amended as follows:

(4)

Article 7(2) is replaced by the following:

(5)

Article 8 is amended as follows:

(6)

Article 10 is amended as follows:

(7)

Article 11 is amended as follows:

(8)

Article 12 is replaced by the following:

(9)

the following Article is inserted:

(*13)   OJ L 124, 17.5.2005, p. 4, ELI: http://data.europa.eu/eli/convention/2005/370/oj.’;"

(10)

in Article 15, paragraph 3 is deleted;

(11)

Article 16 is replaced by the following:

(*14)  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, ELI: http://data.europa.eu/eli/dir/2001/83/oj)."

(*15)  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 (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj)."

(*16)  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj)."

(*17)  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, ELI: http://data.europa.eu/eli/reg/2012/528/oj)."

(*18)  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, ELI: http://data.europa.eu/eli/reg/2019/6/oj)."

(*19)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).’;"

(12)

in Article 17, paragraphs 4 and 5 are deleted;

(13)

in Article 18, paragraph 4 is deleted;

(14)

the following Article is inserted:

(15)

Articles 20 and 21 are replaced by the following:

(*20)  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, ELI: http://data.europa.eu/eli/reg/2011/182/oj).’;"

(16)

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

(17)

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

(18)

in Part B of Annex VII, the following point is added:

;

(19)

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

(20)

Annexes IX and X are deleted.

(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:

(3)

Article 2 is amended as follows:

(4)

Article 3 is amended as follows:

(5)

Article 4 is amended as follows:

(6)

the following Article is inserted:

(*23)  Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, 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, ELI: http://data.europa.eu/eli/dir/2008/105/oj)."

(*24)  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, ELI: http://data.europa.eu/eli/dir/2001/83/oj)."

(*25)  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 (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj)."

(*26)  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, ELI: http://data.europa.eu/eli/dir/2009/128/oj)."

(*27)  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, ELI: http://data.europa.eu/eli/reg/2019/6/oj)."

(*28)  Regulation (EU) 2022/2379 of the European Parliament and of the Council of 23 November 2022 on statistics on agricultural input and output, amending Commission Regulation (EC) No 617/2008 and repealing Regulations (EC) No 1165/2008, (EC) No 543/2009 and (EC) No 1185/2009 of the European Parliament and of the Council and Council Directive 96/16/EC (OJ L 315, 7.12.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/2379/oj)."

(*29)  Regulation (EU) 2024/1244 of the European Parliament and of the Council of 24 April 2024 on reporting of environmental data from industrial installations, establishing an Industrial Emissions Portal and repealing Regulation (EC) No 166/2006 (OJ L, 2024/1244, 2.5.2024, ELI: http://data.europa.eu/eli/reg/2024/1244/oj)."

(*30)  Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial and livestock rearing emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17, ELI: http://data.europa.eu/eli/dir/2010/75/oj).’;"

(7)

Article 8 is replaced by the following:

(8)

the following Article is inserted:

(9)

Article 9 is replaced by the following:

(*31)  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, ELI: http://data.europa.eu/eli/reg/2011/182/oj).’;"

(10)

Article 10 is deleted;

(11)

Annex I is replaced by the text set out 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:

;

(14)

in Annex IV, Part B, point 1, the introductory wording is replaced by the following:

;

(15)

the text set out in Annex V of this Directive is added as Annex V.

(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 environmental quality standards and 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)

in Article 2 the following point is added:

;

(3)

Article 3 is amended as follows:

(4)

Article 5 is replaced by the following:

(*32)  Regulation (EU) 2024/1244 of the European Parliament and of the Council of 24 April 2024 on reporting of environmental data from industrial , establishing an Industrial Emissions Portal and repealing Regulation (EC) No 166/2006 (OJ L, 2024/1244, 2.5.2024, ELI: http://data.europa.eu/eli/reg/2024/1244/oj).’;"

(5)

in Article 7a, paragraph 1 is replaced by the following:

(*33)  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, ELI: http://data.europa.eu/eli/dir/2001/83/oj)."

(*34)  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 (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj)."

(*35)  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj)."

(*36)  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, ELI: http://data.europa.eu/eli/dir/2009/128/oj)."

(*37)  Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial and livestock rearing emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17, ELI: http://data.europa.eu/eli/dir/2010/75/oj)."

(*38)  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, ELI: http://data.europa.eu/eli/reg/2012/528/oj)."

(*39)  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, ELI: http://data.europa.eu/eli/reg/2019/6/oj).’;"

(6)

Articles 8, 8a and 8b are replaced by the following:

(*40)  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, ELI: http://data.europa.eu/eli/dir/2006/118/oj)."

(*40)  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, ELI: http://data.europa.eu/eli/dir/2006/118/oj)."

(*41)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj)."

(*42)  Regulation (EU) 2022/2379 of the European Parliament and of the Council of 23 November 2022 on statistics on agricultural input and output, amending Commission Regulation (EC) No 617/2008 and repealing Regulations (EC) No 1165/2008, (EC) No 543/2009 and (EC) No 1185/2009 of the European Parliament and of the Council and Council Directive 96/16/EC (OJ L 315, 7.12.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/2379/oj)."

(*43)  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, ELI: http://data.europa.eu/eli/dir/2009/90/oj).’;"

(7)

the following Article is inserted:

(8)

Article 9a is amended as follows:

(9)

Article 10 is deleted;

(10)

Annex I is amended in accordance with Annex VI to this Directive;

(11)

the text set out in Annex VII to this Directive is added as Annex II;

(12)

the text set out in Annex VIII to this Directive is added as Annex III.