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EU instrument 32026L0805 · European Union

Articles 8, 8a and 8b are replaced by the following: ‘Article 8 Review of Annexes I and II 1. The Commission shall consider establishing quality standards for PFAS Total in surface waters at the next review of Annex I to this Directive to be conducted in accordance with Article 16 of Directive 2000/60/EC and aim to complement the guidance on monitoring PFAS Total in drinking water, developed in accordance with Article 13(7) of Directive (EU) 2020/2184 of the European Parliament and of the Council (*40), to make it applicable to monitoring PFAS Total in surface waters. Member States are encouraged to already apply that guidance to monitor PFAS Total in surface waters and to report the data in line with Article 8(4) of Directive 2000/60/EC. Considering the toxicity, persistence and prevalence of trifluoroacetic acid (TFA) in the environment, the Commission shall consider establishing a quality standard for TFA separately in Annex I to this Directive at the next review. 2. A parameter “Sum of Bisphenols” and parameters for the sum(s) of selected pesticides by mode of action and selected pharmaceuticals by mode of action are included in Annex III to this Directive. The Commission shall review the possible inclusion of these parameters in the priority substances list at its next review of Annex I to this Directive to be conducted in accordance with Article 16 of Directive 2000/60/EC, and set EQS as appropriate. The Commission shall also consider at the next review whether a risk-based approach could be taken to establishing EQS for total bisphenols, total pesticides and total pharmaceuticals in surface waters, supported by suitable monitoring methods. 3. The Commission is empowered to adopt delegated acts, in accordance with Article 9a, to amend Part B of Annex II in order to adapt it to scientific and technological progress. Article 8a Specific provisions for certain substances 1. In the river basin management plans produced in accordance with Article 13 of Directive 2000/60/EC, without prejudice to the requirements of Section 1.4.3 of Annex V to that Directive regarding the presentation of the overall chemical status and the objectives and obligations laid down in point (a) of Article 4(1), point (k) of Article 11(3) and in Article 16(6) of that Directive, Member States may provide additional maps to present the chemical status as provided for in Section 1.4.3 of Annex V of Directive 2000/60/EC. 2. Member States may monitor substances identified in Part A of Annex I to this Directive as substances behaving like ubiquitous PBTs less intensively than is required for priority substances in accordance with Article 3(4) of this Directive and Annex V to Directive 2000/60/EC, provided that the monitoring is representative and a statistically robust baseline is available regarding the presence of those substances in the aquatic environment. As a guideline, in accordance with the second subparagraph of Article 3(6) of this Directive, monitoring should take place at least every three years, unless the use or emission of the substance, or technical knowledge and expert judgment, justify another interval. 3. Over a period of two years from 1 January 2030, Member States shall monitor the presence of estrogenic substances in water bodies, using effect-based monitoring methods. Sampling and analysis need not commence at the start of that two-year period, but shall be conducted at least four times each year. Member States shall conduct the monitoring at a selection of the sites where the three estrogenic hormones 17-beta estradiol (E2), Estrone (E1) and 17-alpha-ethinylestradiol (EE2), listed in Part A to Annex I to this Directive, are being monitored using conventional analytical methods in accordance with Article 8 of Directive 2000/60/EC and Annex V thereto in order to obtain comparative results at a range of concentrations. Data shall be reported together, and in accordance with Article 8(4) of that Directive. The number of sites shall be no fewer than that specified in Article 8b(3) of this Directive for monitoring substances on the watch list. Member States may start the monitoring before 1 January 2030 as long as the technical specifications referred to in paragraph 4 of this Article have been adopted. Member States shall not use the effect-based results from the two-year comparative monitoring period for the purpose of classifying the chemical status of the monitored water bodies as described in Section 1.4.3 of Annex V to Directive 2000/60/EC. 4. By 1 December 2027, the Commission shall adopt an implementing act setting out the technical specifications for the monitoring of estrogenic substances using effect-based monitoring methods. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 9(2). 5. Within 18 months of the data being reported by the Member States, the Commission shall publish a report comparing the results from the conventional analytical and the effect-based methods and analyse the possibility of using effect-based monitoring methods in conjunction with an effect-based trigger value for estrogens as defined in point 35a of Article 2 of Directive 2000/60/EC for screening purposes to support the assessment of chemical status. In the context of future reviews of the list of pollutants in accordance with Article 16(2) of Directive 2000/60/EC, taking into account the analysis in the report referred to in the first subparagraph of this paragraph, the Commission shall consider setting a trigger value for estrogens for screening purposes and for the assessment of chemical status. Once effect-based methods are ready to use also for other substances, the Commission shall consider, in the context of future reviews, requiring Member States to use them, if necessary, at least initially in parallel with conventional analytical methods, and consider setting corresponding trigger values. Article 8b Watch list 1. The Commission is empowered to adopt implementing acts to establish, having regard to scientific reports prepared by the European Chemicals Agency (ECHA) in accordance with paragraph 1a of this Article, a watch list of substances for which it is necessary to gather Union-wide monitoring data from the Member States for the purpose of supporting future reviews in accordance with Article 16(2) of Directive 2000/60/EC and to lay down the formats to be used by the Member States for reporting the results of that monitoring and related information to the Commission. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 9(2). The watch list shall contain a maximum of 10 substances, groups of substances, or indicators of pollution at any one time and shall indicate the monitoring matrices and the possible methods of analysis for each substance. Those monitoring matrices and methods shall not entail excessive costs for the competent authorities. The substances to be included in the watch list shall be selected from amongst the substances for which the information available indicates that they could pose a significant risk at Union level to, or via, the aquatic environment and for which monitoring data are insufficient. The watch list shall include substances of emerging concern. On the basis of the scientific reports prepared by ECHA in accordance with paragraph 1a, the Commission shall include microplastics and appropriate indicators of the presence, evolution or transmission of antimicrobial resistance (“indicators of antimicrobial resistance”) in the watch list, provided that methods of sampling and analysis that are reliable and do not entail excessive costs are available. By 1 December 2027, the Commission shall identify such methods of sampling and analysis. 1a. ECHA shall prepare scientific reports to assist the Commission in selecting the substances and indicators for inclusion in the watch list referred to in paragraph 1 of this Article, taking into account the following information: 1b. The scientific reports prepared by ECHA in accordance with paragraph 1a shall present a list of substances, groups of substances, or indicators, the recommended monitoring matrix, and an indicative method of analysis and maximum acceptable limit of quantification for each of them, with a supporting reference to scientific literature or guidance. 1c. By 1 February 2028 and every three years thereafter, ECHA shall prepare a report summarising the findings of the scientific reports prepared in accordance with paragraph 1a and shall make that report publicly available. 2. The Commission shall update the watch list referred to in paragraph 1 by 1 May 2028, and every three years thereafter. When updating the watch list, the Commission shall remove any substance or indicator from the watch list for which a risk-based assessment as referred to in Article 16(2) of Directive 2000/60/EC can be conducted without additional monitoring data. However, an individual substance, group of substances, or indicator may be kept on the watch list for another period of maximum three years where additional monitoring data are needed to assess the risk to the aquatic environment. Each updated watch list shall also include one or more additional substances, groups of substances, or indicators for which the Commission considers, on the basis of the scientific reports of ECHA, that there could be a widespread risk to or via the aquatic environment, subject to the updated watch list containing a maximum of 10 substances, groups of substances, or indicators, in accordance with paragraph 1. Microplastics and indicators of antimicrobial resistance shall not be kept on the list for a second consecutive period of three years unless a harmonised and reliable risk assessment methodology is available which, when applied, shows that the monitoring data collected during the first monitoring period are insufficient to assess the risk they pose to or via the aquatic environment. 3. Member States shall monitor each substance, group of substances, and indicator on the watch list referred to in paragraph 1 at selected representative monitoring stations over a 24-month period. The monitoring period shall commence within six months of the inclusion of the substance in the list, but sampling and analysis need not commence at the start of that period. Each Member State shall select at least one monitoring station, plus one station if it has more than one million inhabitants, plus the number of stations equal to its geographical area in km2 divided by 60 000, rounded to the nearest integer, plus the number of stations equal to its population divided by five million, rounded to the nearest integer. In selecting the representative monitoring stations, the monitoring frequency and the timing for each substance, group of substances, or indicator, Member States shall take into account seasonal variability in rainfall, water levels, use patterns and the possibility of the substance, group of substances, or indicator occurring. The frequency of monitoring shall be no less than twice per year when carried out in water and no less than once per year when carried out in sediment or biota. When higher frequencies are required, as for substances that are sensitive to climatic or seasonal variabilities, the increase in frequency shall be set out and technically justified in the implementing act establishing the watch list adopted pursuant to paragraph 1. Where a Member State is in a position to generate and provide the Commission with sufficient, comparable, representative and recent monitoring data for a particular substance, group of substances, or indicator from existing monitoring programmes or studies, it may decide not to undertake additional monitoring under the watch list mechanism for that substance, group of substances, or indicator, provided that the substance, group of substances, or indicator was monitored using a methodology that is compliant with the monitoring matrices and the methods of analysis referred to in the implementing act establishing the watch list, as well as with Commission Directive 2009/90/EC (*43). 4. Member States shall make available the results of the monitoring referred to in paragraph 3 of this Article annually in accordance with Article 8(4) of Directive 2000/60/EC and with the implementing act establishing the watch list adopted pursuant to paragraph 1 of this Article. They shall also make available information on the representativeness of the monitoring stations and on the monitoring strategy. 5. At the end of the 24-month period referred to in paragraph 3 ECHA shall review the monitoring results and assess which substances, groups of substances, or indicators need to be monitored for another 24-month period and therefore are to be kept on the watch list and which substances, groups of substances, or indicators can be removed from the watch list. Where the Commission, having regard to the assessment by ECHA referred to in the first subparagraph of this paragraph, concludes that no further monitoring is required to further assess the risk to the aquatic environment, this assessment by ECHA shall be taken into account in the review of the lists of substances in Annex I or Part C of Annex II to this Directive, in accordance with Article 16 of Directive 2000/60/EC. (*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).’;" Annex I to Directive 2006/118/EC of the European Parliament and of the Council (*40) and the results of the most recent review of that Annex, as well as the results of the most recent regular review of Annex I to this Directive; the watch lists established in accordance with Directives 2006/118/EC and (EU) 2020/2184; recommendations from the stakeholders; Member States’ characterisation of river basin districts in accordance with Article 5 of Directive 2000/60/EC and the results of monitoring programmes established in accordance with Article 8 of that Directive; information on production volumes, use patterns, intrinsic properties, including, where relevant, particle size, concentrations in the environment and adverse effects on human health and the aquatic environment of a substance, including information gathered in accordance with Directive 2001/83/EC, Regulation (EC) No 1907/2006, Regulation (EC) No 1272/2008 of the European Parliament and of the Council (*41), Regulation (EC) No 1107/2009, Directive 2009/128/EC, Regulation (EU) No 528/2012 and Regulation (EU) 2022/2379 of the European Parliament and of the Council (*42); research projects and scientific publications, including information on trends and forecasts based on modelling or other predictive assessments, as well as information and data collected by remote sensing technologies, earth observation, such as Copernicus services, in situ sensors and devices or citizen science data, taking advantage of the opportunities offered by artificial intelligence, and advanced data analysis and processing; recommendations from the working groups established under the Common Implementation Strategy for Directive 2000/60/EC; information on emissions, discharges and losses available in the Industrial Emissions Portal under Regulation (EU) 2024/1244, as well as any additional information available on substances covered by permits under Directive 2010/75/EU.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-08 · Text as adopted (Official Journal); later amendments are not incorporated in this text.