(-1)

Water is not a commercial product like any other but, rather, a common good and a heritage, which needs to be protected, and treated as such, in order to ensure that ecosystems are preserved and that there is universal access to clean water. [Am. 1]

(-1a)

The United Nations General Assembly recognised, on 28 July 2010, 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. Following the success of the 2014 European Citizen’s Initiative entitled ‘Right2Water’ a proposal for the revision of the Directive on drinking water was adopted by the Commission in 2018 and the corresponding amended Directive entered into force on 12 January 2021. That Directive lays down an obligation for Member States to improve access to water intended for human consumption while relying, inter alia, on the knowledge gained and actions carried out under Directive 2000/60/EC. Member States should also ensure the effectiveness of the right to clean water and sanitation by improving the quality of both surface water and groundwater. [Am. 2]

(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 , one of the priority goals of the 8th Environmental Action Programme (3) . [Am. 3]

(1a)

According to the European Environment Agency, around 90 % of the area of groundwater bodies is reported to be in good quantitative status, around 75 % of the groundwater body area is in good chemical status, 40 % of surface water bodies are in good or high ecological status, and 38 % of surface water bodies are in good chemical status, while the European Environment Agency’s report of 4 December 2019 entitled ‘The European environment – state and outlook 2020: Knowledge for transition to a sustainable Europe’ found that reduced pollution has improved water quality, but that the Union was far from achieving good ecological status for all water bodies by 2020. [Am. 4]

(1b)

The 2019 Fitness Check of the Water Framework Directive (‘the Fitness Check’) concluded in its evaluation that the next round of programmes of measures will play a key role in ensuring the necessary progress towards achieving the environmental objectives of Directive 2000/60/EC by the 2027 deadline, and stated that currently more than half of all European water bodies are exempt under Directive 2000/60/EC, which makes the challenges for Member States to achieve the Environmental Quality Standards for priority substances within the given deadline, more than substantial. In addition, the Fitness Check concluded that the environmental objectives have not been reached fully largely due to insufficient funding, slow implementation and insufficient integration of environmental objectives in sectoral policies, and not due to a deficiency in the legislation. [Am. 5]

(1c)

Due to geographical and socioeconomic factors, some populations, including indigenous peoples, are more vulnerable to water pollution. The mining sector in the European Union is expected to grow to ensure the development of the net zero industry. As stated in Report 09/2021 from the European Environmental Agency (4), the mining sector directly impacts water quality and quantity. It is, therefore, necessary to better implement the existing legislative frameworks and to plan and control water use and discharge also in mining operations. [Am. 6]

(1d)

Many territories in the Union are subject to large and increasing water constraints. The significant and persistent droughts of recent years, especially in the Mediterranean regions, are putting agricultural production at risk and causing a serious decline in surface and groundwater reserves (5). [Am. 7]

(1e)

Water is a public good for the benefit of all which, as an essential natural resource that is irreplaceable and indispensable to life, needs to be carefully considered in the light of its social, economic and environmental dimensions. Climate change, including the increased frequency of natural disasters and extreme weather events, and the degradation of biodiversity, both negatively affect water quality and quantity, leading to pressure on sectors dependent on the availability of water, particularly agriculture. [Am. 8]

(1f)

While in its 2018 Report on ‘European waters - assessment of status and pressures’, the European Environment Agency (EEA) identified certain agricultural practices as obstacles to achieving good chemical status of groundwater in the Union, leading to nitrate and pesticide pollution, a steady decrease in use of mineral fertilisers and in nutrient surpluses has been observed in the Union over the last decades (6). Other significant sources of pollution are discharges that are not connected to a sewerage system, contaminated sites or abandoned industrial sites. [Am. 9]

(1g)

Good status of water bodies and efficient management of water resources represents a priority for agriculture, since farmers rely on water to conduct their activity, and as such, have a vested interest in the sustainable use of such resources. [Am. 10]

(1h)

In order to facilitate a transition to a more sustainable and productive agricultural sector that is resilient as regards water constraints, incentives should be put in place for farmers to improve water management and modernisation of irrigation systems and techniques. [Am. 11]

(1i)

Pesticide use can severely affect water quality and the quantity of water available for agricultural use, leading to negative impacts on both aquatic and terrestrial biodiversity. It is therefore appropriate to monitor the impact and ecotoxicological fate of pesticides and their metabolites in water bodies. [Am. 12]

(1j)

It is essential to consider the efforts achieved so far in sectors such as agriculture, where it has already been possible to reduce phytosanitary contamination by 14 % compared to 2015-2017 and by 26 % if considering the most harmful pollutants. The figures, therefore, show a continuous reduction in the use and risk of chemicals, with 2020 being the second consecutive year in which there has been a significant reduction in the use of pesticides, especially the most dangerous (7). [Am. 13]

(1k)

Chemical pollution of surface and groundwater also poses a threat to agriculture by limiting the availability of water suitable for crop irrigation, and further aggravating water scarcity. The Union and Member States should, therefore, increase support for research and innovation to rapidly deploy solutions to tackle surface and groundwater scarcity and pollution, including digitalisation, precision agriculture, optimised irrigation and modernisation of irrigation and a circular use of resources, for improved climate-resilient water management and a more targeted application of pesticides and fertilisers for crops, less polluting and safer alternatives to agricultural inputs, more resistant and nutrient-efficient varieties of crops and increased usage of treated wastewater for agricultural irrigation. This should contribute to achieving a sustainable and resilient Union food system while reducing diffuse pollution from agriculture and the need for agricultural abstraction. [Am. 14]

(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.

(2a)

In seeking to achieve a high level of environmental protection and in implementing the Zero Pollution Action Plan, 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. [Am. 15]

(3)

The European Green Deal (8) 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 (9) and the Zero Pollution Action Plan (10) specifically address pollution aspects of the European Green Deal. Other particularly relevant and complementary policies include the 2018 EU Plastics Strategy (11), the 2021 Pharmaceuticals Strategy for Europe (12), the Biodiversity Strategy (13), the Farm to Fork Strategy (14), the EU Soil Strategy for 2030 (15), the EU’s Digital Strategy (16) and the EU’s Data Strategy (17).

(3a)

The objectives of achieving ‘good status of water bodies’ and ensuring water availability are cross-cutting and are often not pursued in a sufficiently coherent way. Good water management should be mainstreamed in all Union policies concerning water-using sectors. [Am. 16]

(3b)

The Fitness Check pointed out that better integration of water objectives in agricultural policy was necessary. The new CAP introduced measures making water management more sustainable. In order to have enhanced coherence between agriculture and water policy, Member States should make full use of the opportunities available in the new CAP and integrate water issues fully in their strategic plans, including use of Agricultural Knowledge and Innovation Systems (AKIS), and facilitate the development of advisory services to promote best practices concerning water management. [Am. 17]

(4)

Directive 2000/60/EC of the European Parliament and of the Council (18) 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 (19) 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 (20). Directive 2006/118/EC of the European Parliament and of the Council (21) 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 establish such national threshold values. The groundwater quality standards are set out in Annex I to Directive 2006/118/EC. [Am. 18]

(4a)

Member States should ensure that pollution through the discharge, emission or loss of priority hazardous substances ceases or is 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. [Am. 19]

(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, toxicity, mobility, carcinogenicity, mutagenicity, reprotoxicity and endocrine disrupting potential. [Am. 20]

(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 should 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 (22), Regulation (EC) No 1107/2009 of the European Parliament and of the Council (23), Regulation (EU) No 528/2012 of the European Parliament and of the Council (24), Regulation (EU) 2019/6 of the European Parliament and of the Council (25), Directive 2001/83/EC of the European Parliament and of the Council (26), Directive 2009/128/EC of the European Parliament and of the Council (27), Directive 2010/75/EU of the European Parliament and of the Council (28) and Council Directive 91/271/EEC (29). In order for the Member States to achieve the environmental objectives laid down in Article 4 of Directive 2000/60/EC in the best and most cost-effective way possible, they should ensure, when establishing their programmes of measures, that source-control measures are prioritized over end-of-pipe measures and that those measures are in accordance with relevant Union sectoral legislation on pollution. When there is a risk of source-control measures failing to achieve good status of the water bodies, end-of-pipe measures should be applied. The Commission should develop guidance on best practices for source-control measures and the complementarity of end-of-pipe measures. [Am. 21]

(7a)

Water pollution is mainly the result of industrial and agricultural activities, sewage discharges, and urban runoff, including storm water. The Commission and the Member States should prioritise in their actions measures reducing pollution at source, as well as their enforcement. To this end, 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. [Am. 22]

(7b)

In order to ensure the legislation intended for preventing pollution of surface water and groundwater is up to date in relation to the fast-evolving pace of new and emerging chemicals that have the potential, as pollutants, to cause significant risks to human health and the aquatic environment, policy mechanisms to detect and assess such substances of emerging concern should be strengthened. In this regard, an approach that allows monitoring and analysis of additional numbers of such substances or groups of substances under the watch lists for surface water and groundwater should be devised. The substances or group of substances to be placed on the watch list should be selected from amongst those substances for which the information available indicates that they could pose a significant risk at Union level to, or via, the aquatic environment, and for which the monitoring data are insufficient. The number of such substances or groups of substances to be monitored and analysed under the watch lists for surface water and groundwater should not be limited. [Am. 23]

(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. A subset of specific PFAS as well as of PFAS total should therefore be added to the list of groundwater pollutants. 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. A subset of specific PFAS as well as of PFAS total should therefore be added to the list of priority substances. 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 Annex I to Directive 2006/118/EC by setting a quality standard for PFAS total. Watch-list monitoring under Article 8b of Directive 2008/105/EC has also confirmed a risk in surface waters from a number of pharmaceutical substances which should therefore be added to the priority substances list. [Am. 24]

(8a)

Glyphosate is the most frequently used herbicide within the Union for agricultural use. As an active substance, it has raised serious concerns in terms of its impact on human health and aquatic toxicity. In December 2022, the Commission decided to grant a temporary extension of the glyphosate marketing authorisation for one additional year, pending the European Food Safety Authority’s reassessment of the active substance due in July 2023. Various recent scientific studies (30) suggest, however, that an environmental quality standard (EQS) lower than 0,1 μg /L for all surface water bodies should be considered based on the aquatic toxicity of glyphosate, AMPA and glyphosate-based herbicides. Considering the ongoing assessments by competent Union regulators and the scientific findings of relevant studies regarding the impacts of glyphosate on aquatic life, and for the purpose of ensuring the good chemical status of the majority of Union waters, based on the precautionary principle, a common and unified AA-EQS for inland surface waters and, separately, for other surface waters, should be adopted in relation to glyphosate. [Am. 25]

(8b)

Atrazine is a herbicide used for annual broad-leaved weeds and annual grasses in cereals. The use of atrazine in plant protection products is no longer authorised within the Union pursuant to Commission Decision 2004/248/EC (31). Atrazine has been proven to be an endocrine disruptor, with evidence that it interferes with reproduction and development, and it could be a cause of cancer. The European Environmental Agency, assessing pesticides against effect or quality thresholds between 2013 and 2020, found that exceedances of one or more pesticides, mainly exceedances of atrazine and its metabolites, were detected at between 4 % and 11 % of groundwater monitoring sites. Considering its persistent presence in Union surface and groundwater and in order to ensure the threshold values for atrazine do not exceed the total pesticides and metabolites EQS, the threshold value for atrazine in Annex I to Directive 2008/105/EC should be adjusted, also in accordance with the threshold value for the same substance set in Directive (EU) 2020/2184 (32). [Am. 26]

(8c)

According to SCHEER (33)and EMA (34), the generic quality standard of 0,1 μg/L and 0,5 μg/L for groundwater, suggested for individual pesticides and for the sum of all pesticides respectively, as specified in Directive 2006/118/EC, was established in the 1980s, based on the chemical-analytical sensitivity available at that time. The default value of 0,1 μg/L for individual pesticides is not proven to be sufficiently protective for human health and the groundwater ecosystem, and is sometimes significantly higher in comparison to threshold values for many pesticides and fungicides on the list of priority substances in Annex I to Directive 2008/105/EC. Taking into consideration also SCHEER's opinion that no groundwater threshold values should be higher than the EQS for surface water, the Commission should review the threshold values for individual pesticides and the sum of all pesticides, including their relevant metabolites, in Annex I to Directive 2006/118/EC by applying modern analytical methods and comparing them in relation to the best available toxicological knowledge. Pending this review, and in line with the precautionary approach expressed by drinking water providers in the European Groundwater Memorandum (35), interim threshold values, based on best available scientific knowledge, should be established. [Am. 27]

(8d)

Bisphenol-A should be treated as a priority hazardous substance and should be added to the list in Annex I to Directive 2008/105/EC. Scientific reports show that also bisphenols other than bisphenol-A have proven endocrine-disrupting potential and mixtures of those bisphenols represent an ecotoxicological risk. Given that those scientific findings raise concerns regarding the safe use of alternatives to bisphenols that might have a negative impact on human health and the environment, the Commission should establish a 'Bisphenols Total' parameter and an appropriate EQS for the total of bisphenol substances. [Am. 28]

(8e)

According to the European Medicines Agency (EMA) (36), groundwater ecosystems are fundamentally different and therefore can be more vulnerable to stressors than surface water ecosystems as they lack the ability to recover from perturbations. Therefore, a precautionary approach should be applied when setting groundwater threshold values to protect human health, groundwater ecosystems and groundwater-dependent ecosystems. In line with advice from EMA, as a result of this vulnerability, the threshold values applicable to groundwater should normally be 10 times lower than the corresponding threshold values for surface waters. However, where the actual risk posed to the groundwater eco-systems can be established, it could be appropriate to set threshold values for groundwater at a different level. [Am. 29]

(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 (37).

(9a)

Pursuant to applicable Union law, Member States are obliged to identify affected and at-risk waters, designate nitrate-vulnerable zones, develop action programmes and implement relevant measures. In this regard, there is still a need for an improvement in the harmonisation of control measures and water quality measurement systems between Member States, so as to allow for harmonised standards across the Union that make comparability between Member States possible, thus avoiding competition problems in the European agricultural sector, resulting in disturbances to the internal market. [Am. 30]

(10)

It is estimated that in 2019, between 900 000 and 1,7 million deaths around the world were attributable to antimicrobial resistance (AMR) infections (38). 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. 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. [Am. 31]

(10a)

Commission Implementing Decision (EU) 2020/1729 repealing Implementing Decision 2013/652/EU sets the framework to obtain comparable and reliable data on antimicrobial resistance in the European Union, including by monitoring slaughterhouse wastewater as a potential vehicle of antibiotic-resistant bacteria and therefore a possible environmental contamination route. Antibiotic-resistant bacteria have been found in water discharged by slaughterhouses. [Am. 32]

(10b)

Concern has been expressed about the risk of sulfates and xanthates in the aquatic environment. Sulfates not only impair drinking water quality, they also affect the material cycles of carbon, nitrogen and phosphorus. Among other things, this increases the nutrient loads in water bodies and thus the growth of plants and algae and also increases food supply for aquatic organisms and leads to a decrease of oxygen in water. Sulfates and their degradation products, especially sulfide, under certain conditions, can have a toxic effect on aquatic life. Standard test results indicate that some xanthates and their degradation products are toxic to aquatic invertebrates and fish species and that they may bioaccumulate. Sulfates are already listed as a pollutant for groundwater, but the monitoring that has taken place has been insufficient. Sulfates should therefore be included in the surface and ground water watch lists. Xanthates should be included in the surface water watch list. [Am. 33]

(10c)

Substances such as microplastics pose a clear risk to public health and the environment, but also to basic activities such as the development of agriculture. The presence of such substances and other particles can have implications not only on the water received by livestock and crops, but also on soil fertility, thereby compromising the health and good development of present and future crops (39). [Am. 34]

(11)

The current and conventional monitoring methods for the chemical status of water bodies cannot, in general, determine the impact of complex mixtures of chemicals on water quality. 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 should be included in an evaluation report published by the Commission in which it assesses whether effect-based monitoring methods deliver robust and accurate data and 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 Commission should be empowered to adopt delegated acts to supplement Directive 2008/105/EC to set out modalities for the Member States to use the effect-based methods for monitoring to assess the presence also of other substances in water bodies, in anticipation of a possible setting of effect-based trigger values in the future. The definition of EQS in Directive 2000/60/EC should be modified to ensure that it may, in the future, also covertrigger values that might be set for assessing the results of effect-based monitoring. [Am. 35]

(11a)

More stringent threshold values should be established where groundwater quality standards could result in failure to achieve the environmental objectives of Directive 2000/60/EC for associated water bodies, as required under Directive 2006/118/EC. That requirement under Directive 2006/118/EC should be further extended to better protect vulnerable sites from pollution. [Am. 36]

(12)

The evaluation of Union water legislation (40) (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 Therefore , rather than in the framework of the ordinary legislative procedure as currently provided for in Articles 16 and 17 of any future review of Annex I to Directive 2000/60/EC and Article 10 of 2008/105/EC with regard to the list of priority substances and corresponding EQS set out in Part A of that Annex and of Annex I to 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 should be improved, the links between the watch-list mechanism and the reviews of the lists of pollutants could should be strengthened, and changes to the review period for the lists of pollutants could should be adjusted in order to 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 Commission 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 , while maintaining the obligation to take measures aimed at the cessation or phasing out of discharges, emissions and losses of priority hazardous substances . [Am. 37]

(12a)

Overall, the conclusions of the Fitness check indicate that the Directives are broadly fit for purpose, with scope for improvement, including accelerating the proper implementation of their objectives, which might be achieved through more Union funding. The assessment indicates that the Directives have so far generally led to a higher level of protection of water bodies and flood risk management. [Am. 38]

(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.

(13a)

Any decision on the selection, review of substances and the setting of EQS should be based on a risk assessment and follow a proportionate, transparent and science-based approach and take into consideration recommendations from the European Parliament, Member States and relevant stakeholders. [Am. 39]

(13b)

While Directive 2000/60/EC set the rules necessary to make progress in relation to water quantity and quality, the Fitness check showed that the slow progress made as regards achieving the objectives of this Directive can amongst other things be attributed to a lack of sufficient financial resources as well as regulatory and ecological complexity, including possible time lags for groundwater to respond to measures and with regard to reporting timelines. Measures that improve the status of water bodies through restoration of rivers and ecosystem services provide financial benefits that outweigh the costs and could reduce unnecessary expenditure for Member States. Furthermore, the evaluation points to a lack of implementation, an insufficient scope, and insufficient or inadequate restoration measures ensuring hydrological and ecological connectivity (41). [Am. 40]

(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 establish national threshold values. [Am. 41]

(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.

(20a)

In order to provide for adequate protection standards for areas of high ecological value, vulnerability or pollution, such as caves and karst areas, that contain ecosystems that are among the most vulnerable to contamination and represent an important drinking water supply, as well as for former industrial sites and other areas with known historical contamination, the Commission should publish an assessment of the chemical status of such areas and, where appropriate, present a legislative proposal to revise Directive 2006/118/EC accordingly. [Am. 42]

(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. In relation to assessing threshold values for pharmaceutical substances, ECHA should cooperate with the European Medicines Agency ('EMA'). [Am. 43]

(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 (42) as well as under Directive (EU) 2019/1024 of the European Parliament and of the Council (43). 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 (44), 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. [Am. 44]

(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 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). 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 (45).

(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 (46), 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 and the best available methods 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. [Am. 45]

(31a)

Industrial activities related to the energy transition could increase adverse impacts on the water quality. Mitigating such future impacts, such as changes to natural flow patterns and temperature, and water pollution, requires assessing the full range of potential factors as well as measures to be taken to achieve and maintain good water quality. Therefore, Member States should regularly evaluate the impact on water quality of industrial activities related to the energy transition and inform the Commission of newly identified threats with the aim of updating the watch list accordingly. The evaluation should be easily accessible to the public and the update should be allowed to occur outside of the general updating cycles, to ensure a continuous improvement of water quality assessment. [Am. 46]

(31b)

The Commission, in its communication of 11 December 2019 on the European Green Deal and its communication of 14 October 2020 on improving access to justice in environmental matters, committed to taking action to improve access to justice before national courts in all Member States for citizens and environmental non-governmental organisations that have specific concerns about the compatibility of administrative acts that have effects on the environment with environmental law. In the latter communication, the Commission affirms that ‘access to justice in environmental matters, both via the Court of Justice of the EU (CJEU) and the national courts as Union courts, is an important support measure to help deliver the European Green Deal transition and a way to strengthen the role which civil society can play as watchdog in the democratic space’. Those commitments should be implemented also under Directive 2000/60/EC. [Am. 47]

(31c)

As confirmed by the case law of the CJEU (47), environmental non-governmental organisations and directly concerned individuals should be provided legal standing in order to challenge a decision taken by a public authority, which is in breach of the environmental objectives referred to in Article 4 of Directive 2000/60/EC. With the purpose of enhancing access to justice in the matters concerned before national courts across the Union and for environmental non-governmental organisations and directly concerned individuals to be able to rely on national laws when challenging decisions that are in breach of Directive 2000/60/EC, provisions to ensure access to justice should be established in Directive 2000/60/EC. [Am. 48]

(32)

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 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 n 1313/2013/EU of the European Parliament and of the Council (48). Considering that river basin districts can also extend beyond the territory of the Union, ensuring that there is effective implementation of relevant provisions for water protection under Directive 2000/60/EC as well as appropriate coordination with the relevant non-Member States would also contribute to the objectives as set out in Directive 2000/60/EC for those specific river basin districts, as referred to in Article 3(5) of Directive 2000/60/EC. In addition, armed conflicts taking place in close geographical proximity to the Union should also be considered as exceptional events due to their extensive negative transboundary environmental impact, including air, soil and water pollution. As the river basins affected by such conflicts could extend within the Union’s boundaries, the Commission and Member States should increase their endeavours to establish appropriate coordination with relevant non-Member States as referred to in Article 3(5) of Directive 2000/60/EC. [Am. 49]

(32a)

The European Court of Auditors in its report of 19 May 2021 entitled ‘The Polluter Pays Principle: Inconsistent application across EU environmental policies and actions’ notes that Member States already spend around EUR 100 billion per year on water supply and sanitation and that increases of that expenditure are expected to amount to over 25 % to meet the objectives of Union legislation on wastewater treatment and drinking water, while not including investments needed to renew existing infrastructure or meet the objectives of the Water Framework Directive and the Floods Directive. Furthermore, in the Union, users pay on average for around 70 % of the cost of providing water services, through water tariffs, while the public purse finances the remaining 30 %, although there are considerable differences between regions and Member States. Households in the Union usually pay for most of the cost of water supply and sanitation services, even though they consume only 10 % of water, whereas the economic sectors that exert the most pressure on renewable freshwater resources contribute the least to meeting such costs. [Am. 50]

(32b)

The costs of monitoring programmes for determining the status of surface water and ground water are financed solely through Member States’ budgets. Given that the number of chemicals detected in the aquatic environment is constantly changing, that there is a growing number of emerging pollutants which have just recently appeared in the aquatic environment, that constant improvement of chemical analytical methods is required in order to detect these emerging and new pollutants and correctly assess their ecological impact, and that also new monitoring methods need to be developed in order to better assess effects of chemical mixtures, those monitoring costs are expected to increase even further. In order to cover those costs, and in accordance with the polluter pays principle enshrined in Article 191(2) of the Treaty on the Functioning of the European Union (TFEU), it is essential that producers placing on the Union market products that contain substances which have a proven or potential negative impact on human health and the aquatic environment take financial responsibility for the measures required to control substances generated in the context of their commercial activities and found in surface water and groundwater. A system of extended producer responsibility is likely the most appropriate means of achieving this, as it would limit the financial burden on the taxpayer, while providing an incentive to develop greener products. The Commission should, therefore, prepare an impact assessment examining the inclusion in Directive 2006/118/EC and Directive 2008/105/EC of an extended producer responsibility mechanism, applicable to priority substances defined under Directive 2006/118/EC and under Directive 2008/105/EC, as well as to emerging and new pollutants, as defined in the watch lists under Directive 2006/118/EC and Directive 2008/105/EC. The impact assessment should be accompanied, where appropriate, by a legislative proposal to revise Directives 2006/118/EC and 2008/105/EC. [Am. 51]

(32c)

Monitoring of an increased number of substances or group of substances involves increased costs but also the need for strengthened administrative capacity in the Member States, especially those with scarcer resources. In light of the above, the Commission should set up a joint European monitoring facility for managing the monitoring requirements when so requested by the Member States, thus easing their financial and administrative burdens. The Commission should define the methods of operation of the monitoring facility. The use of such facility should be voluntary and without prejudice to arrangements already set in place by the Member States. [Am. 52]

(32d)

Evidence shows that there is an investment need in the water sector and Union funding is vital for some Member States to comply with legal obligations laid down in Directive 2000/60/EC, Directive 2008/105/EC and Directive 2006/118/EC. All Member States need to increase their expenditure by at least 20 % to reach Union water standards and there is an aggregated financing gap of EUR 289 billion up to 2030 (49). It is therefore necessary to ensure that sufficient financial and human resources are provided for the purpose of carrying out monitoring and inspections of water bodies in all Member States, including via relevant Union structural funds and programmes, as well as via contributions from the private sector, including under the extended producer responsibility mechanism, once put in place. [Am. 53]

(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,

(34a)

Member States should encourage synergies between the requirements of the relevant directives concerning both data collection and deployment of digital tools such as remote sensing technologies or earth observation (Copernicus services). [Am. 54]

(34b)

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 the directives. Information should be accessible in the different national languages in order to strengthen accessibility to the relevant data across Europe for the relevant local actors and citizens. [Am. 55]

(1)

in Article 1 , point (e) , the fourth indent is replaced by the following: [Am. 56]

(2)

Article 2 is amended as follows:

(3)

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

(4)

Article 4(1) is amended as follows:

(5)

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

(*2)  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:

(7)

Article 10 is amended as follows:

(7a)

Article 11(1) is replaced by the following:

(7b)

Article 11(3), point (c) is replaced by the following:

(8)

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

(8a)

Article 11(5), indent 2 is replaced by the following:

(9)

Article 12 is replaced by the following:

(9a)

in Article 13, the following paragraph is inserted:

(9b)

The following Article is inserted:

(10)

in Article 15, paragraph 3 is deleted; [Am. 74]

(10a)

in Article 15(3) the following subparagraph is added:

‘ The Commission shall adopt guidelines and templates concerning the content, structure and format of the interim reports referred to in the first subparagraph, no later than [six months after the entry into force of this Directive]. ’ [Am. 75]

(11)

Articles 16 and 17 are deleted;

(12)

Article 18 is amended as follows:

(13)

Article 20 is replaced by the following:

(14)

the following Article 20a is inserted:

(15)

Article 21 is replaced by the following:

(*11)  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).;’ "

(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 A of Annex VII, point 7.7. is replaced by the following:

(18a)

In Annex VII, Part A, the following point is inserted:

(19)

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

(20)

Annex X is Annexes IX and X are deleted. [Am. 78]

(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)

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

(4)

Article 3 is amended as follows:

(5)

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

(6)

the following Article 6a is inserted:

(*12)  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)."

(*13)  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)."

(*14)  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)."

(*15)  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)."

(*16)  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)."

(*17)  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)."

(*18)  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)."

(*19)  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).’ "

(6a)

The following Article is inserted:

(6b)

The following Article is inserted:

(6c)

The following Article is inserted:

(6d)

The following Article is inserted:

(7)

Article 8 is replaced by the following:

(8)

the following Article 8a is inserted:

(9)

Article 9 is 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).;’ "

(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:

(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 , including seasonal upward trends caused, inter alia, by low discharge of a water body, 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:.’ [Am. 107]

(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;’

(1b)

Article 1 is amended as follows:

(2)

Article 3 is amended as follows:

(3)

Article 5 is amended as follows:

(4)

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

(*22)  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)."

(*23)  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)."

(*24)  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).;’ "

(4)

In Article 7a, paragraph 2 is replaced by the following:

(5)

Article 8 is replaced by the following:

(*25)  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)."

(*26)  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:

(*27)  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)."

(*28)  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:

(*29)  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).;’ "

(7a)

The following Article 8ba is inserted:

(7b)

The following Article is inserted:

(8)

the following Article 8d is inserted:

(8a)

In Article 9a, paragraph 2 is amended as follows:

(8b)

In Article 9a, paragraph 3 is amended as follows:

(8c)

In Article 9a, paragraph 3a is inserted:

(8d)

In Article 9a, paragraph 5 is amended as follows:

(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.