Article 1 Objectives
1. This Directive concerns the quality of water intended for human consumption for all in the Union. 2. The objectives of this Directive are to protect human health from the adverse effects of any contamination of water intended for human consumption by ensuring that it is wholesome and clean, and to improve access to water intended for human consumption.
Article 2 Definitions
For the purposes of this Directive, the following definitions apply: (1) ‘water intended for human consumption’ means: (a) all water, either in its original state or after treatment, intended for drinking, cooking, food preparation or other domestic purposes in both public and private premises, regardless of its origin and whether it is supplied from a distribution network, supplied from a tanker or put into bottles or containers, including spring waters; (b) all water used in any food business for the manufacture, processing, preservation or marketing of products or substances intended for human consumption; (2) ‘domestic distribution system’ means the pipework, fittings and appliances which are installed between the taps that are normally used for water intended for human consumption in both public and private premises and the distribution network, but only if they are not the responsibility of the water supplier, in its capacity as a water supplier, under the relevant national law; (3) ‘water supplier’ means an entity supplying water intended for human consumption; (4) ‘priority premises’ means large non-household premises with many users potentially exposed to water-related risks, in particular large premises for public use, as identified by Member States; (5) ‘food business’ means a food business as defined in point (2) of Article 3 of Regulation (EC) No 178/2002; (6) ‘food business operator’ means a food business operator as defined in point (3) of Article 3 of Regulation (EC) No 178/2002; (7) ‘hazard’ means a biological, chemical, physical or radiological agent in water, or another aspect of the condition of water, with the potential to cause harm to human health; (8) ‘hazardous event’ means an event that introduces hazards into, or fails to remove them from, the supply system of water intended for human consumption; (9) ‘risk’ means a combination of the likelihood of a hazardous event and the severity of the consequences if the hazard and hazardous event occur in the supply system of water intended for human consumption; (10) ‘starting substance’ means a substance that has been intentionally added in the production of organic materials or of admixtures for cementitious materials; (11) ‘composition’ means the chemical composition of a metal, enamel, ceramic or other inorganic material.
Article 3 Exemptions
1. This Directive shall not apply to: (a) natural mineral waters recognised as such by the responsible authority, as referred to in Directive 2009/54/EC; or (b) waters which are medicinal products within the meaning of Directive 2001/83/EC. 2. Maritime vessels that desalinate water, carry passengers and act as water suppliers shall only be subject to Articles 1 to 6 and Articles 9, 10, 13 and 14 of this Directive and its relevant Annexes. 3. Member States may exempt from this Directive: (a) water intended exclusively for those purposes for which the competent authorities are satisfied that the quality of the water has no influence, either directly or indirectly, on the health of the consumers concerned; (b) water intended for human consumption from an individual supply providing less than 10 m 3 a day as an average or serving fewer than 50 persons, unless the water is supplied as part of a commercial or public activity. 4. Member States that have recourse to the exemptions provided for in point (b) of paragraph 3 shall ensure that the population concerned is informed of such recourse to exemptions and of any action that can be taken to protect human health from the adverse effects resulting from any contamination of water intended for human consumption. In addition, where a potential danger to human health arising from the quality of such water is apparent, the population concerned shall promptly be given appropriate advice. 5. Member States may exempt food business operators from this Directive as regards the water used for the specific purposes of the food business, if the competent national authorities are satisfied that the quality of such water cannot affect the safety of the foodstuff in its finished form and provided that the water supply of the food business complies with relevant obligations, in particular under the procedures on hazard analysis and critical control point principles and remedial actions under relevant Union legislation on food. Member States shall ensure that producers of water intended for human consumption that is put into bottles or containers comply with Articles 1 to 5 and Parts A and B of Annex I. However, the minimum requirements set out in Part A of Annex I shall not apply to spring water as referred to in Directive 2009/54/EC. 6. Water suppliers supplying less than 10 m 3 a day as an average or serving fewer than 50 persons as part of a commercial or public activity shall only be subject to Articles 1 to 6 and Articles 13, 14 and 15 of this Directive and its relevant Annexes.
Article 4 General obligations
1. Without prejudice to their obligations under other Union law, Member States shall take the measures necessary to ensure that water intended for human consumption is wholesome and clean. For the purposes of the minimum requirements of this Directive, water intended for human consumption shall be wholesome and clean if all the following requirements are met: (a) that water is free from any micro-organisms and parasites and from any substances which, in numbers or concentrations, constitute a potential danger to human health; (b) that water meets the minimum requirements set out in Parts A, B and D of Annex I; (c) Member States have taken all other measures necessary to comply with Articles 5 to 14. 2. Member States shall ensure that the measures taken to implement this Directive are based on the precautionary principle and in no circumstances have the effect of allowing, directly or indirectly, any deterioration of the present quality of water intended for human consumption or any increase in the pollution of waters used for the production of water intended for human consumption. 3. In accordance with Directive 2000/60/EC, Member States shall ensure that an assessment of water leakage levels within their territory and of the potential for improvements in water leakage reduction is performed using the infrastructural leakage index (ILI) rating method or another appropriate method. That assessment shall take into account relevant public health, environmental, technical and economic aspects and cover at least water suppliers supplying at least 10 000 m 3 per day or serving at least 50 000 people. The results of the assessment shall be communicated to the Commission by 12 January 2026. By 12 January 2028, the Commission shall adopt a delegated act in accordance with Article 21 in order to supplement this Directive, by setting out a threshold, based on ILI or another appropriate method, above which Member States shall present an action plan. That delegated act shall be drafted using the Member States’ assessments and the Union average leakage rate determined on the basis of those assessments. Within two years of the adoption of the delegated act referred to in the third subparagraph, Member States having a leakage rate exceeding the threshold set out in the delegated act shall present an action plan to the Commission laying down a set of measures to be taken in order to reduce their leakage rate.
Article 5 Quality standards
1. Member States shall set values applicable to water intended for human consumption for the parameters set out in Annex I. 2. The parametric values set pursuant to paragraph 1 of this Article shall not be less stringent than those set out in Parts A, B, C and D of Annex I. As regards the parameters set out in Part C of Annex I, the values shall be set only for monitoring purposes and for the sake of ensuring that the requirements set out in Article 14 are met. 3. A Member State shall set values for additional parameters not included in Annex I, where the protection of human health within its national territory or part of it so requires. The values set shall, as a minimum, satisfy the requirements of point (a) of Article 4(1).
Article 6 Point of compliance
1. The parametric values set in accordance with Article 5 for the parameters listed in Parts A and B of Annex I shall be complied with: (a) in the case of water intended for human consumption supplied from a distribution network, at the point, within premises or an establishment, at which the water emerges from the taps that are normally used for water intended for human consumption; (b) in the case of water intended for human consumption supplied from a tanker, at the point at which the water emerges from the tanker; (c) in the case of water intended for human consumption put into bottles or containers, at the point at which the water is put into the bottles or containers; (d) in the case of water intended for human consumption used in a food business, at the point at which the water is used in that business. 2. In the case of water intended for human consumption covered by point (a) of paragraph 1 of this Article, Member States shall be deemed to have fulfilled their obligations under this Article and under Article 4 and Article 14(2) where it can be established that non-compliance with the parametric values set in accordance with Article 5 is due to the domestic distribution system or the maintenance thereof, without prejudice to Article 10 as regards priority premises. 3. Where paragraph 2 of this Article applies and there is a risk that water intended for human consumption covered by point (a) of paragraph 1 of this Article would not comply with the parametric values set in accordance with Article 5, Member States shall nevertheless ensure that: (a) appropriate measures are taken to reduce or eliminate the risk of non-compliance with the parametric values, such as advising property owners of any possible remedial action they could take, and if necessary that other measures, such as appropriate treatment techniques, are taken to change the nature or properties of the water before it is supplied so as to reduce or eliminate the risk of the water not complying with the parametric values after supply; and (b) the consumers concerned are duly informed and advised of any possible additional remedial action that they should take.
Article 7 Risk-based approach to water safety
1. Member States shall ensure that the supply, treatment and distribution of water intended for human consumption is subject to a risk-based approach that covers the whole supply chain from the catchment area, abstraction, treatment, storage and distribution of water to the point of compliance specified in Article 6. The risk-based approach shall entail the following elements: (a) risk assessment and risk management of the catchment areas for abstraction points of water intended for human consumption in accordance with Article 8; (b) risk assessment and risk management for each supply system that includes the abstraction, treatment, storage and distribution of water intended for human consumption to the point of supply carried out by the water suppliers in accordance with Article 9; and (c) risk assessment of the domestic distribution systems in accordance with Article 10. 2. Member States may adapt the implementation of the risk-based approach, without compromising the objective of this Directive concerning the quality of water intended for human consumption and the health of consumers, when there are particular constraints due to geographical circumstances such as remoteness or limited accessibility of the water supply zone. 3. Member States shall ensure that there is a clear and appropriate distribution of responsibilities between stakeholders, as defined by the Member States, for the implementation of the risk-based approach. Such distribution of responsibilities shall be tailored to their institutional and legal framework. 4. The risk assessment and risk management of the catchment areas for abstraction points of water intended for human consumption shall be carried out for the first time by 12 July 2027. That risk assessment and risk management shall be reviewed at regular intervals of no longer than six years, taking account of the requirements provided for in Article 7 of Directive 2000/60/EC, and updated where necessary. 5. The risk assessment and risk management of the supply system shall be carried out for the first time by 12 January 2029. That risk assessment and risk management shall be reviewed at regular intervals of no longer than six years, and updated where necessary. 6. The risk assessment of the domestic distribution systems shall be carried out for the first time by 12 January 2029. That risk assessment shall be reviewed every six years, and updated where necessary. 7. The deadlines specified in paragraphs 4, 5 and 6 shall not prevent Member States from ensuring that measures are taken as soon as possible once risks are identified and assessed.
Article 8 Risk assessment and risk management of the catchment areas for abstraction points of water intended for human consumption
1. Without prejudice to Articles 4 to 8 of Directive 2000/60/EC, Member States shall ensure that risk assessment and risk management of the catchment areas for abstraction points of water intended for human consumption are carried out. 2. Member States shall ensure that the risk assessment includes the following elements: (a) characterisation of the catchment areas for abstraction points including: (i) identification and mapping of the catchment areas for abstraction points; (ii) mapping of the safeguard zones, where those zones have been established in accordance with Article 7(3) of Directive 2000/60/EC; (iii) geo-references for all abstraction points in the catchment areas; given that those data are potentially sensitive, in particular in the context of public health and public security, the Member States shall ensure that such data are protected and communicated only to the relevant authorities and water suppliers; (iv) description of land-use, runoff, and recharge processes in the catchment areas for abstraction points; (b) identification of hazards and hazardous events in the catchment areas for abstraction points and an assessment of the risk they could pose to the quality of water intended for human consumption; that assessment shall assess potential risks that might cause deterioration of the water quality to the extent that it could constitute a risk to human health; (c) appropriate monitoring in surface water or groundwater, or both, in the catchment areas for abstraction points, or in raw water, of relevant parameters, substances or pollutants selected from the following: (i) parameters in Parts A and B of Annex I or set in accordance with Article 5(3) of this Directive; (ii) groundwater pollutants in Annex I to Directive 2006/118/EC of the European Parliament and of the Council ( 28 ) , and pollutants and indicators of pollution for which threshold values have been established by Member States in accordance with Annex II to that Directive; (iii) priority substances and certain other pollutants in Annex I to Directive 2008/105/EC of the European Parliament and of the Council ( 29 ) ; (iv) river basin specific pollutants established by Member States in accordance with Directive 2000/60/EC; (v) other pollutants relevant for water intended for human consumption established by Member States on the basis of the information collected in accordance with point (b) of this subparagraph; (vi) naturally occurring substances that could constitute a potential danger for human health through use of water intended for human consumption; (vii) substances and compounds included in the watch list as established in accordance with Article 13(8) of this Directive. For the purposes of point (a) of the first subparagraph, Member States may use information collected in accordance with Articles 5 and 7 of Directive 2000/60/EC. For the purposes of point (b) of the first subparagraph, Member States may use the review of the impact of human activity undertaken in accordance with Article 5 of Directive 2000/60/EC and information on significant pressures collected in accordance with points 1.4, 1.5 and 2.3 to 2.5 of Annex II to that Directive. Member States shall select from points (c)(i) to (c)(vii) of the first subparagraph the parameters, substances or pollutants that are considered relevant for monitoring in light of the hazards and hazardous events identified under point (b) of the first subparagraph or in light of the information provided by the water suppliers in accordance with paragraph 3. For the purpose of appropriate monitoring as referred to in point (c) of the first subparagraph, including to detect new substances that are harmful to human health through use of water intended for human consumption, Member States may use the monitoring performed in accordance with Articles 7 and 8 of Directive 2000/60/EC or other Union legislation and relevant to the catchment areas for abstraction points. 3. Water suppliers that perform monitoring in the catchment areas for abstraction points or in raw water shall be required to inform the competent authorities of trends in, and of unusual numbers or concentrations of, monitored parameters, substances or pollutants. 4. On the basis of the outcome of the risk assessment carried out in accordance with paragraph 2, Member States shall ensure that the following risk management measures to prevent or control the risks identified are taken as relevant, starting with the preventive measures: (a) defining and implementing preventive measures in the catchment areas for abstraction points in addition to the measures foreseen or taken in accordance with point (d) of Article 11(3) of Directive 2000/60/EC, where required to safeguard the quality of the water intended for human consumption; where appropriate, those preventive measures shall be included in the programmes of measures referred to in Article 11 of that Directive; where appropriate, Member States shall ensure that polluters, in cooperation with water suppliers and other relevant stakeholders, take such preventive measures in accordance with Directive 2000/60/EC; (b) defining and implementing mitigation measures in the catchment areas for abstraction points in addition to the measures foreseen or taken in accordance with point (d) of Article 11(3) of Directive 2000/60/EC, where required to safeguard the quality of the water intended for human consumption; where appropriate, those mitigation measures shall be included in the programmes of measures referred to in Article 11 of that Directive; where appropriate, Member States shall ensure that polluters, in cooperation with water suppliers and other relevant stakeholders, take such mitigation measures in accordance with Directive 2000/60/EC; (c) ensuring appropriate monitoring of parameters, substances or pollutants in surface water or groundwater, or both, in the catchment areas for abstraction points, or in raw water, that could constitute a risk to human health through water consumption or lead to unacceptable deterioration of the quality of water intended for human consumption and that have not been taken into consideration in the monitoring performed in accordance with Articles 7 and 8 of Directive 2000/60/EC; where appropriate, this monitoring shall be included in the monitoring programmes referred to in Article 8 of that Directive; (d) evaluation of the need to establish or adapt safeguard zones for groundwater and surface water, as referred to in Article 7(3) of Directive 2000/60/EC, and any other relevant zones. Member States shall ensure that the effectiveness of any measures referred to in this paragraph is reviewed at appropriate intervals. 5. Member States shall ensure that water suppliers and competent authorities have access to the information referred to in paragraphs 2 and 3. In particular, relevant water suppliers shall have access to the monitoring results obtained under point (c) of the first subparagraph of paragraph 2. On the basis of the information referred to in paragraphs 2 and 3, Member States may: (a) require water suppliers to perform additional monitoring or treatment of certain parameters; (b) allow water suppliers to decrease the monitoring frequency of a parameter, or to remove a parameter from the list of parameters to be monitored by the water supplier in accordance with point (a) of Article 13(2), without being required to carry out a risk assessment of the supply system, provided that: (i) the parameter is not a core parameter within the meaning of point 1 of Part B of Annex II; and (ii) no factor that can be reasonably anticipated is likely to cause deterioration of the quality of water intended for human consumption. 6. Where a water supplier is allowed to decrease the monitoring frequency of a parameter or remove a parameter from the list of parameters to be monitored, as referred to in point (b) of the second subparagraph of paragraph 5, Member States shall ensure that appropriate monitoring of those parameters is performed when reviewing the risk assessment and risk management of the catchment areas for abstraction points, in accordance with Article 7(4).
Article 9 Risk assessment and risk management of the supply system
1. Member States shall ensure that risk assessment and risk management of the supply system are carried out by the water supplier. 2. Member States shall ensure that the risk assessment of the supply system: (a) takes into account the results of the risk assessment and risk management of the catchment areas for abstraction points carried out in accordance with Article 8; (b) includes a description of the supply system from the abstraction point, treatment, storage and distribution of water to the point of supply; and (c) identifies the hazards and hazardous events in the supply system and includes an assessment of the risks they could pose to human health through use of water intended for human consumption, taking into consideration risks stemming from climate change, leakages and leaking pipes. 3. On the basis of the outcome of the risk assessment carried out in accordance with paragraph 2, Member States shall ensure that the following risk management measures are taken: (a) defining and implementing control measures for the prevention and mitigation of the risks identified in the supply system that could compromise the quality of water intended for human consumption; (b) defining and implementing control measures in the supply system in addition to the measures foreseen or taken in accordance with Article 8(4) of this Directive or Article 11(3) of Directive 2000/60/EC for the mitigation of risks coming from the catchment areas for abstraction points that could compromise the quality of water intended for human consumption; (c) implementing a supply-specific operational monitoring programme in accordance with Article 13; (d) ensuring that, where disinfection forms part of the preparation or distribution of water intended for human consumption, the efficiency of the disinfection applied is validated, that any contamination from disinfection by-products is kept as low as possible without compromising the disinfection, that any contamination from treatment chemicals is kept as low as possible and that any substances remaining in the water do not compromise the fulfillment of the general obligations set out in Article 4; (e) verifying that materials, treatment chemicals and filter media that come into contact with water intended for human consumption used in the supply system comply with Articles 11 and 12. 4. On the basis of the outcome of the risk assessment of the supply system carried out in accordance with paragraph 2, Member States shall: (a) allow the possibility of decreasing the monitoring frequency of a parameter or of removing a parameter from the list of parameters to be monitored, except for the core parameters referred to in point 1 of Part B of Annex II, if the competent authority is satisfied that to do so would not compromise the quality of water intended for human consumption: (i) on the basis of the occurrence of a parameter in raw water, in accordance with the risk assessment of the catchment areas for abstraction points as set out in Article 8(1) and (2); (ii) when a parameter can only occur as a result of the use of a certain treatment technique or disinfection method, and that technique or method is not used by the water supplier; or (iii) on the basis of the specifications set out in Part C of Annex II; (b) ensure that the list of parameters to be monitored in water intended for human consumption in accordance with Article 13 is extended or that the monitoring frequency is increased: (i) on the basis of the occurrence of a parameter in raw water, in accordance with the risk assessment of the catchment areas for abstraction points as set out in Article 8(1) and (2); or (ii) on the basis of the specifications set out in Part C of Annex II. 5. The risk assessment of the supply system shall concern parameters listed in Parts A, B and C of Annex I, parameters set in accordance with Article 5(3) and substances or compounds included in the watch list established in accordance with Article 13(8). 6. Member States may exempt water suppliers supplying between 10 and 100 m 3 per day as an average or serving between 50 and 500 people from the requirement to carry out risk assessment and risk management of the supply system, provided that the competent authority is satisfied that such an exemption would not compromise the quality of water intended for human consumption. In the event of such an exemption, the exempted water suppliers shall carry out regular monitoring in accordance with Article 13.
Article 10 Risk assessment of domestic distribution systems
1. Member States shall ensure that a risk assessment of domestic distribution systems is carried out. That risk assessment shall comprise the following elements: (a) a general analysis of the potential risks associated with domestic distribution systems, and with related products and materials, and whether those potential risks affect the quality of water at the point where it emerges from the taps that are normally used for water intended for human consumption; this general analysis shall not entail an analysis of individual properties; and (b) monitoring of the parameters listed in Part D of Annex I in premises where specific risks to water quality and human health have been identified during the general analysis performed under point (a). In relation to Legionella or lead, Member States may decide to focus the monitoring referred to in point (b) of the first subparagraph on priority premises. 2. Where Member States conclude, on the basis of the general analysis carried out under point (a) of the first subparagraph of paragraph 1, that there is a risk to human health stemming from domestic distribution systems or from the related products and materials, or where monitoring performed in accordance with point (b) of the first subparagraph of paragraph 1 demonstrates that the parametric values set out in Part D of Annex I are not met, Member States shall ensure that appropriate measures are taken to eliminate or reduce the risk of non-compliance with the parametric values set out in Part D of Annex I. In relation to Legionella , those measures shall target at least priority premises. 3. In order to reduce the risks connected with domestic distribution across all domestic distribution systems, Member States shall ensure that all of the following measures are considered and that those measures considered relevant are taken: (a) encourage owners of public and private premises to carry out a risk assessment of the domestic distribution system; (b) inform consumers and owners of public and private premises about measures to eliminate or reduce the risk of non-compliance with the quality standards for water intended for human consumption due to the domestic distribution system; (c) advise consumers about the conditions of consumption and use of water intended for human consumption, and about possible action to avoid the reoccurrence of those risks; (d) promote training for plumbers and other professionals dealing with domestic distribution systems and the installation of construction products and materials that come into contact with water intended for human consumption; (e) in relation to Legionella , ensure that effective control and management measures which are proportionate to the risk are in place to prevent and address possible outbreaks of the disease; and (f) in relation to lead, if economically and technically feasible, implement measures for substitution of components made of lead in existing domestic distribution systems.
Article 11 Minimum hygiene requirements for materials that come into contact with water intended for human consumption
1. For the purposes of Article 4, Member States shall ensure that materials that are intended to be used in new installations or, in the case of repair works or reconstruction, in existing installations for the abstraction, treatment, storage or distribution of water intended for human consumption and that come into contact with such water do not: (a) directly or indirectly compromise the protection of human health as provided for by this Directive; (b) adversely affect the colour, odour or taste of the water; (c) enhance microbial growth; (d) leach contaminants into the water at levels that are higher than necessary in view of the intended purpose of the material. 2. For the purpose of ensuring the uniform application of paragraph 1, the Commission shall adopt implementing acts to establish the specific minimum hygiene requirements for materials that come into contact with water intended for human consumption on the basis of the principles set out in Annex V. Those implementing acts shall establish: (a) by 12 January 2024, methodologies for testing and accepting starting substances, compositions and constituents to be included in European positive lists of starting substances, compositions or constituents, including specific migration limits and scientific pre-conditions related to substances or materials; (b) by 12 January 2025, on the basis of lists including expiry dates compiled by ECHA, European positive lists of starting substances, compositions or constituents for each group of materials, namely organic, cementitious, metallic, enamels and ceramic or other inorganic materials, which are authorised for use in the manufacture of materials or products in contact with water intended for human consumption, including, where appropriate, conditions for their use and migration limits, which are to be determined on the basis of the methodologies adopted pursuant to point (a) of this subparagraph, and taking into account paragraphs 3 and 4; (c) by 12 January 2024, procedures and methods for testing and accepting final materials as used in a product made from materials or combinations of starting substances, compositions or constituents on the European positive lists, including: (i) the identification of relevant substances and other parameters, such as turbidity, flavour, odour, colour, total organic carbon, the release of unexpected substances and enhancement of microbial growth, to be tested in migration water; (ii) methods for testing the effects on water quality, having regard to any relevant European standards; (iii) pass/fail criteria for the test results, which take into account, inter alia, conversion factors for substance migration into estimated levels at the tap, and conditions of application or use, where appropriate. The implementing acts provided for in this paragraph shall be adopted in accordance with the examination procedure referred to in Article 22. 3. The first European positive lists to be adopted in accordance with point (b) of the first subparagraph of paragraph 2 shall be based, inter alia, on existing national positive lists, other existing national provisions and on the risk assessments that led to the establishment of such national lists. For this purpose, Member States shall notify ECHA of any existing national positive lists, other provisions and available assessment documents by 12 July 2021. The European positive list of starting substances for organic materials shall take into account the list established by the Commission pursuant to Article 5 of Regulation (EC) No 1935/2004. 4. The European positive lists shall contain the only starting substances, compositions or constituents that are authorised for use as referred to in point (b) of the first subparagraph of paragraph 2. The European positive lists shall contain expiry dates set on the basis of a recommendation from ECHA. The expiry dates shall be set in particular on the basis of the hazardous properties of the substances, the quality of the underlying risk assessments, and the extent to which those risk assessments are up-to-date. The European positive lists may also contain transitional provisions. On the basis of opinions from ECHA as referred to in paragraph 6, the Commission shall regularly review and update, where necessary, the implementing acts referred to in point (b) of the first subparagraph of paragraph 2, in line with the latest scientific and technological developments. The first review shall be completed by 15 years after the adoption of the first European positive list. The Commission shall ensure that any relevant acts, or standardisation mandates, which it adopts pursuant to other Union legislation are consistent with this Directive. 5. For the purpose of inclusion in or removal from the European positive lists of starting substances, compositions or constituents, economic operators or relevant authorities shall submit applications to ECHA. The Commission shall adopt delegated acts in accordance with Article 21, in order to supplement this Directive, by laying down a procedure, including information requirements, on the application process. The procedure shall ensure that applications are accompanied by risk assessments and that economic operators or relevant authorities deliver the necessary information for the risk assessment in a specific format. 6. The Committee for Risk Assessment of ECHA set up pursuant to point (c) of Article 76(1) of Regulation (EC) No 1907/2006 shall issue an opinion on any application submitted pursuant to paragraph 5 within a time limit to be set out in the delegated acts referred to in that paragraph. Further procedural provisions on the application process and on the issuing of opinions by the Committee for Risk Assessment of ECHA may also be included in those delegated acts. 7. Member States shall consider that products approved in accordance with specific minimum hygiene requirements provided for in paragraph 2 satisfy the requirements set out in paragraph 1. Member States shall ensure that only such products in contact with water intended for human consumption that use final materials approved in accordance with this Directive can be placed on the market for the purposes of this Directive. This shall not prevent Member States, in particular when specific local raw water quality so requires, from adopting more stringent protective measures for the use of final materials in specific or duly justified circumstances, in accordance with Article 193 TFEU. Such measures shall be notified to the Commission. Regulation (EU) 2019/1020 shall apply to products covered by this Article. 8. The Commission shall adopt delegated acts in accordance with Article 21, in order to supplement this Directive, by determining the appropriate conformity assessment procedure applicable to products covered by this Article on the basis of the modules in Annex II to Decision No 768/2008/EC of the European Parliament and of the Council ( 30 ) . In determining which conformity assessment procedure is to be used, the Commission shall ensure that the objectives referred to in Article 1(2) of this Directive are complied with, whilst taking into account the principle of proportionality. For this purpose, the Commission shall take as a starting point the System 1+ of assessment and verification of constancy of performance set out in Annex V to Regulation (EU) No 305/2011, or a broadly equivalent procedure, except where it would be disproportionate. The delegated acts referred to in this paragraph shall also contain rules for the designation of conformity assessment bodies, where such are involved in the respective conformity assessment procedures. 9. Pending the adoption of the implementing acts referred to in paragraph 2, Member States shall be entitled to maintain or adopt national measures on specific minimum hygiene requirements for the materials referred to in paragraph 1, provided that those measures comply with the rules of the TFEU. 10. The Commission shall request one or several European standardisation organisations to draft a European standard for uniform testing and assessment of products in contact with water intended for human consumption in accordance with Article 10 of Regulation (EU) No 1025/2012 of the European Parliament and of the Council ( 31 ) , in order to facilitate compliance with this Article. 11. The Commission shall adopt delegated acts in accordance with Article 21 in order to supplement this Directive by establishing harmonised specifications for a conspicuous, clearly legible and indelible marking to be used to indicate that products in contact with water intended for human consumption are in conformity with this Article. 12. No later than 12 January 2032, the Commission shall review the functioning of the system as set out in this Article and present a report to the European Parliament and the Council, based in particular on experience gained through the application of Regulations (EC) No 1935/2004 and (EU) No 305/2011, assessing whether: (a) human health as regards the matters covered by this Article is adequately protected throughout the Union; (b) the internal market for products in contact with water intended for human consumption is functioning properly; (c) there is a need for any further legislative proposal on the matters covered by this Article.
Article 12 Minimum requirements for treatment chemicals and filter media that come into contact with water intended for human consumption
1. For the purposes of Article 4, Member States shall ensure that treatment chemicals and filter media that come into contact with water intended for human consumption do not: (a) directly or indirectly compromise the protection of human health as provided for by this Directive; (b) adversely affect the colour, odour or taste of the water; (c) unintentionally enhance microbial growth; (d) contaminate the water at levels that are higher than necessary in view of the intended purpose. 2. For the national implementation of the requirements of this Article, Article 4(2) shall apply accordingly. 3. Pursuant to paragraph 1 of this Article, and without prejudice to Regulation (EU) No 528/2012 and by using relevant European standards for specific treatment chemicals or filter media, Member States shall ensure that the purity of treatment chemicals and filter media is assessed and the quality of such chemicals and filter media is guaranteed.
Article 13 Monitoring
1. Member States shall take all measures necessary to ensure that regular monitoring of the quality of water intended for human consumption is carried out in accordance with this Article and Parts A and B of Annex II, in order to check that the water available to consumers meets the requirements of this Directive and in particular the parametric values set in accordance with Article 5. Samples of water intended for human consumption shall be taken so that they are representative of its quality throughout the year. 2. To meet the obligations imposed in paragraph 1, appropriate monitoring programmes shall be established in accordance with Part A of Annex II for all water intended for human consumption. Those monitoring programmes shall be supply-specific, taking into account the outcomes of the risk assessment of the catchment areas for abstraction points and of the supply systems, and shall consist of the following elements: (a) monitoring of the parameters listed in Parts A, B and C of Annex I, and of the parameters set in accordance with Article 5(3), in accordance with Annex II, and, where a risk assessment of the supply system is carried out, in accordance with Article 9 and Part C of Annex II, unless a Member State decides that one of those parameters can be removed, in accordance with point (b) of the second subparagraph of Article 8(5) or point (a) of Article 9(4), from the list of parameters to be monitored; (b) monitoring of the parameters listed in Part D of Annex I, for the purposes of the risk assessment of domestic distribution systems, as provided for in point (b) of Article 10(1); (c) monitoring of the substances and compounds included in the watch list, in accordance with the fifth subparagraph of paragraph 8 of this Article; (d) monitoring, for the purposes of the identification of hazards and hazardous events, as provided for in point (c) of the first subparagraph of Article 8(2); (e) operational monitoring conducted in accordance with point 3 of Part A of Annex II. 3. The sampling points shall be determined by the competent authorities and shall meet the relevant requirements set out in Part D of Annex II. 4. Member States shall comply with the specifications for the analysis of parameters set out in Annex III, in accordance with the following principles: (a) methods of analysis other than those specified in Part A of Annex III may be used, provided that it can be demonstrated that the results obtained are at least as reliable as those produced by the methods specified in Part A of Annex III, by providing the Commission with all relevant information concerning such methods and their equivalence; (b) for the parameters listed in Part B of Annex III, any method of analysis may be used provided that it meets the requirements set out therein. 5. Member States shall ensure that additional monitoring is carried out on a case-by-case basis of substances and micro-organisms for which no parametric value has been set in accordance with Article 5, if there is reason to suspect that they may be present in numbers or concentrations which constitute a potential danger to human health. 6. By 12 January 2024, the Commission shall adopt delegated acts in accordance with Article 21 in order to supplement this Directive by adopting a methodology to measure microplastics with a view to including them on the watch list referred to in paragraph 8 of this Article once the conditions set out under that paragraph are fulfilled. 7. By 12 January 2024, the Commission shall establish technical guidelines regarding methods of analysis for monitoring of per- and polyfluoroalkyl substances under the parameters ‘PFAS Total’ and ‘Sum of PFAS’, including detection limits, parametric values and frequency of sampling. 8. The Commission shall adopt implementing acts to establish and update a watch list addressing substances or compounds of concern to the public or the scientific community on health grounds (‘the watch list’), such as pharmaceuticals, endocrine-disrupting compounds and microplastics. Substances and compounds shall be added to the watch list where they are likely to be present in water intended for human consumption and could pose a potential risk to human health. To that end, the Commission shall make use, in particular, of scientific research of the WHO. The addition of any new substance or compound shall be duly justified under Articles 1 and 4. Beta-estradiol and Nonylphenol shall be included in the first watch list in view of their endocrine-disrupting properties and the risk they pose to human health. The first watch list shall be established by 12 January 2022. The watch list shall indicate a guidance value for each substance or compound and where necessary a possible method of analysis that does not entail excessive costs. Member States shall put in place monitoring requirements with regard to the potential presence of the substances or compounds which are included in the watch list, at relevant points of the supply chain for water intended for human consumption. For this purpose, Member States may take into account the information collected under Article 8(1), (2) and (3) of this Directive and may use the monitoring data collected in accordance with Directives 2000/60/EC and 2008/105/EC or other relevant Union legislation, in order to avoid overlapping of monitoring requirements. The monitoring results shall be included in the data sets, set up in accordance with point (b) of Article 18(1), together with the results of the monitoring performed under point (c) of the first subparagraph of Article 8(2). Where a substance or compound included in the watch list is detected, under Article 8(2) or under the fifth subparagraph of this paragraph, in concentrations exceeding the guidance values set out in the watch list, Member States shall ensure that the following measures are considered and that those measures considered relevant are taken: (a) preventive measures, mitigation measures or appropriate monitoring in the catchment areas for abstraction points or in raw water as set out in points (a), (b) and (c) of the first subparagraph of Article 8(4); (b) requiring water suppliers to carry out monitoring of those substances or compounds, in accordance with point (a) of the second subparagraph of Article 8(5); (c) requiring water suppliers to check whether treatment is adequate to reach the guidance value and, where necessary, to optimise the treatment; and (d) remedial actions in accordance with Article 14(6) where Member States consider it necessary to protect human health. The implementing acts provided for in this paragraph shall be adopted in accordance with the examination procedure referred to in Article 22.
Article 14 Remedial action and restrictions of use
1. Member States shall ensure that any failure to meet the parametric values set in accordance with Article 5 is immediately investigated in order to identify the cause. 2. If, despite the measures taken to meet the obligations imposed in Article 4(1), water intended for human consumption does not meet the parametric values set in accordance with Article 5, and without prejudice to Article 6(2), the Member State concerned shall ensure that the necessary remedial action is taken as soon as possible to restore the quality of that water and shall give priority to its enforcement, having regard to, inter alia, the extent to which the relevant parametric value has been exceeded and the associated potential danger to human health. In the event of non-compliance with the parametric values set out in Part D of Annex I, remedial action shall include the measures set out in Article 10(3). 3. Regardless of whether any failure to comply with the parametric values has occurred, Member States shall ensure that any supply of water intended for human consumption which constitutes a potential danger to human health is prohibited or the use of such water restricted and that any other remedial action that is necessary to protect human health is taken. Member States shall consider a failure to meet the minimum requirements for parametric values set out in Parts A and B of Annex I as a potential danger to human health, except where the competent authority considers the non-compliance with the parametric value to be trivial. 4. In the cases described in paragraphs 2 and 3, where the non-compliance with the parametric values is considered to be a potential danger to human health, Member States shall as soon as possible take all of the following measures: (a) notify all affected consumers of the potential danger to human health and its cause, of the exceedance of a parametric value and of the remedial actions taken, including prohibition or restriction of use or other action; (b) give, and regularly update, the necessary advice to consumers on conditions of consumption and use of the water, taking particular account of population groups with increased water-related health risks; and (c) inform consumers once it has been established that there is no longer a potential danger to human health and inform them that the service has returned to normal. 5. The competent authorities or other relevant bodies shall decide what action under paragraph 3 is to be taken, bearing in mind the risks to human health which would be caused by an interruption of the supply or a restriction in the use of water intended for human consumption. 6. In the event of non-compliance with the parametric values or with the specifications set out in Part C of Annex I, Member States shall consider whether that non-compliance poses any risk to human health. They shall take remedial action to restore the quality of water intended for human consumption where that is necessary to protect human health.
Article 15 Derogations
1. In duly justified circumstances, Member States may provide for derogations from the parametric values set out in Part B of Annex I, or set in accordance with Article 5(3), up to a maximum value to be determined by them, provided that such derogations do not constitute a potential danger to human health and provided that the supply of water intended for human consumption in the area concerned cannot be maintained by any other reasonable means. Such derogations shall be limited to the following: (a) a new catchment area for the abstraction of water intended for human consumption; (b) a new source of pollution detected at the catchment area for the abstraction of water intended for human consumption or parameters newly searched for or detected; or (c) an unforeseen and exceptional situation in an existing catchment area for the abstraction of water intended for human consumption that could lead to temporary limited exceedances of the parametric values. Derogations referred to in the first subparagraph shall be limited to as short a period as possible and shall not exceed three years in duration. Towards the end of the period of the derogation, Member States shall conduct a review to determine whether sufficient progress has been made. In exceptional circumstances, a Member State may grant a second derogation in respect of points (a) and (b) of the first subparagraph. Where a Member State intends to grant such a second derogation, it shall communicate the results of the review, along with the grounds for its decision on the second derogation, to the Commission. Such a second derogation shall not exceed three years in duration. 2. Any derogation granted in accordance with paragraph 1 shall specify the following: (a) the grounds for the derogation; (b) the parameter concerned, previous relevant monitoring results, and the maximum permissible parametric value under the derogation; (c) the geographical area, the quantity of water supplied each day, the population concerned and whether any relevant food business operator would be affected; (d) an appropriate monitoring scheme, with an increased monitoring frequency where necessary; (e) a summary of the plan for the necessary remedial action, including a timetable for the work and an estimate of the cost and provisions for reviewing; and (f) the duration of the derogation. 3. If the competent authorities consider the non-compliance with the parametric value to be trivial, and if action taken in accordance with Article 14(2) is sufficient to remedy the problem within 30 days, the information provided for in paragraph 2 of this Article does not need to be specified in the derogation. In that event, only the maximum permissible value for the parameter concerned and the time allowed to remedy the problem shall be set by the competent authorities or other relevant bodies in the derogation. 4. If there is a failure to comply with any parametric value for a given water supply on more than 30 days on aggregate during the previous 12 months, recourse may no longer be had to paragraph 3. 5. Any Member State which has granted a derogation as provided for in this Article shall ensure that the population affected by any such derogation is promptly informed in an appropriate manner of that derogation and of the conditions governing it. In addition, the Member State shall, where necessary, ensure that advice is given to particular population groups for which the derogation could present a special risk. The obligations referred to in the first subparagraph shall not apply in the circumstances described in paragraph 3, unless the competent authorities decide otherwise. 6. This Article shall not apply to water intended for human consumption put into bottles or containers.
Article 16 Access to water intended for human consumption
1. Without prejudice to Article 9 of Directive 2000/60/EC and to the principles of subsidiarity and proportionality, whilst taking into account the local, regional and cultural perspectives and circumstances for water distribution, Member States shall take the necessary measures to improve or maintain access to water intended for human consumption for all, in particular for vulnerable and marginalised groups, as defined by the Member States. For that purpose, Member States shall: (a) identify people without access, or with limited access, to water intended for human consumption, including vulnerable and marginalised groups, and reasons for such lack of access; (b) assess possibilities for improving access for such people; (c) inform such people about possibilities for connecting to the distribution network or about alternative means of having access to water intended for human consumption; and (d) take measures that they consider necessary and appropriate to ensure that there is access to water intended for human consumption for vulnerable and marginalised groups. 2. In order to promote the use of tap water intended for human consumption, Member States shall ensure that outdoor and indoor equipment is set up in public spaces, where technically feasible, in a manner that is proportionate to the need for such measures and taking into account specific local conditions, such as climate and geography. Member States may also take the following measures to promote the use of tap water intended for human consumption: (a) raising awareness of the nearest outdoor or indoor equipment; (b) launching campaigns to inform citizens about the quality of such water; (c) encouraging the provision of such water in public administrations and public buildings; (d) encouraging the provision of such water, for free or for a low service fee, for customers in restaurants, canteens and catering services. 3. Member States shall ensure that the necessary assistance, as defined by the Member States, for competent authorities is facilitated in order to implement the measures referred to in this Article.
Article 17 Information to the public
1. Member States shall ensure that adequate, up-to-date information on water intended for human consumption is available in accordance with Annex IV, while complying with applicable data protection rules. 2. Member States shall ensure that all persons supplied with water intended for human consumption receive the following information regularly and at least once a year, without having to request it, and in the most appropriate and easily accessible form, for example on invoices or by digital means such as smart applications: (a) information on the quality of water intended for human consumption, including the indicator parameters; (b) the price of water intended for human consumption supplied, per litre and cubic metre; (c) the volume consumed by the household, at least per year or per billing period, together with yearly trends of the household consumption, if technically feasible and if this information is available to the water supplier; (d) comparisons of the yearly water consumption of the household with an average household consumption, when applicable in accordance with point (c); (e) a link to the website containing the information set out in Annex IV. 3. Paragraphs 1 and 2 shall be without prejudice to Directives 2003/4/EC and 2007/2/EC.
Article 18 Information on monitoring of implementation
1. Without prejudice to Directives 2003/4/EC and 2007/2/EC, Member States, assisted by the EEA, shall: (a) set up by 12 January 2029, and update every six years thereafter, a data set containing information on measures taken to improve access to and promote the use of water intended for human consumption in accordance with Article 16, and on the share of their population that has access to water intended for human consumption; this does not include water put into bottles or containers; (b) set up by 12 July 2027, and update every six years thereafter, a data set containing information related to the risk assessment and risk management of the catchment areas for abstraction points carried out in accordance with Article 8, and set up by 12 January 2029, and update every six years thereafter, a data set containing information related to the risk assessment of domestic distribution systems carried out in accordance with Article 10, including the following elements: (i) information on catchment areas for abstraction points under point (a) of the first subparagraph of Article 8(2); (ii) the results of the monitoring performed under point (c) of the first subparagraph of Article 8(2) and point (b) of the first subparagraph of Article 10(1); and (iii) concise information on measures taken pursuant to Article 8(4) and Article 10(2) and (3), including information on the type of measures taken, and the progress made, under point (f) of Article 10(3); (c) set up, and update annually thereafter, a data set containing monitoring results, in cases of exceedances of the parametric values set out in Parts A and B of Annex I, collected in accordance with Articles 9 and 13 and information about the remedial actions taken in accordance with Article 14; (d) set up, and update annually thereafter, a data set containing information on incidents relating to water intended for human consumption that have caused a potential risk to human health, regardless of whether any failure to meet the parametric values occurred, that lasted for more than 10 consecutive days and that affected at least 1 000 people, including the causes of those incidents and remedial actions taken in accordance with Article 14; and (e) set up, and update annually thereafter, a data set containing information on all derogations granted in accordance with Article 15(1), including the information provided for in Article 15(2). Where possible, spatial data services as defined in point (4) of Article 3 of Directive 2007/2/EC shall be used to present the data sets referred to in the first subparagraph. 2. Member States shall ensure that the Commission, the EEA and the European Centre for Disease Prevention and Control have access to the data sets referred to in paragraph 1. 3. The EEA shall publish and update a Union-wide overview on the basis of the data collected by the Member States on a regular basis or upon request from the Commission. The Union-wide overview shall include, as appropriate, indicators for outputs, results and the impact of this Directive, Union-wide overview maps and Member State overview reports. 4. The Commission may adopt implementing acts specifying the format of, and modalities for presenting, the information to be provided in accordance with paragraphs 1 and 3, including detailed requirements regarding the indicators, the Union-wide overview maps and the Member State overview reports referred to in paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22. 5. Member States may derogate from this Article on any of the grounds referred to in Article 13(1) of Directive 2007/2/EC.
Article 19 Evaluation
1. The Commission shall, by 12 January 2035, carry out an evaluation of this Directive. The evaluation shall be based, inter alia, on the following elements: (a) the experience gained through the implementation of this Directive; (b) the data sets from Member States set up in accordance with Article 18(1) and the Union-wide overviews compiled by the EEA in accordance with Article 18(3); (c) relevant scientific, analytical and epidemiological data; (d) WHO recommendations, where available. 2. In the context of the evaluation, the Commission shall pay particular attention to the following aspects: (a) the risk-based approach set out in Article 7; (b) provisions related to access to water intended for human consumption, set out in Article 16; (c) provisions concerning the information to be provided to the public under Article 17 and Annex IV. 3. The Commission shall, no later than 12 January 2029, and thereafter where appropriate, submit a report to the European Parliament and to the Council on the potential threat to sources of water intended for human consumption from microplastics, pharmaceuticals and, if necessary, other contaminants of emerging concern, and on the relevant associated potential health risks.
Article 20 Review and amendment of Annexes
1. At least every five years, the Commission shall review Annexes I and II in light of scientific and technical progress as well as of the Member States’ risk-based approach to water safety contained in the data sets established pursuant to Article 18 and, where appropriate, shall submit a legislative proposal to amend this Directive. 2. The Commission is empowered to adopt delegated acts in accordance with Article 21 in order to amend Annex III where necessary to adapt it to scientific and technical progress. The Commission is empowered to adopt delegated acts in accordance with Article 21 in order to amend the parametric value of Bisphenol A in Part B of Annex I, to the extent necessary to adapt it to scientific and technical progress, essentially based on the ongoing review carried out by EFSA.
Article 21 Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 4(3), 11(5), 11(8), 11(11), 13(6) and 20(2) shall be conferred on the Commission for a period of five years from 12 January 2021. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 4(3), 11(5), 11(8), 11(11), 13(6) and 20(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 4(3), 11(5), 11(8), 11(11), 13(6) and 20(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 22 Committee procedure
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Article 23 Penalties
Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by 12 January 2023, notify the Commission of those rules and of those measures and shall notify it of any subsequent amendment affecting them.
Article 24 Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Articles 1 to 18, Article 23 and Annexes I to V by 12 January 2023. They shall immediately communicate the text of those measures to the Commission. When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directive repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 25 Transitional period
1. By 12 January 2026, Member States shall take the measures necessary to ensure that water intended for human consumption complies with the parametric values set out in Part B of Annex I for Bisphenol A, Chlorate, Chlorite, Haloacetic Acids, Microcystin-LR, PFAS Total, Sum of PFAS and Uranium. 2. Until 12 January 2026, water suppliers shall not be obliged to monitor water intended for human consumption in accordance with Article 13 for the parameters listed in paragraph 1 of this Article.
Article 26 Repeal
1. Directive 98/83/EC, as amended by the acts listed in Part A of Annex VI, is repealed with effect from 13 January 2023, without prejudice to the obligations of the Member States relating to the time-limits for the transposition into national law of the Directives set out in Part B of Annex VI. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex VII. 2. Derogations granted by Member States in accordance with Article 9(1) of Directive 98/83/EC that are still applicable on 12 January 2023 shall remain applicable until the end of their duration. They may be renewed in accordance with Article 15 of this Directive only where a second derogation has not yet been granted. The right to ask the Commission for a third derogation in accordance with Article 9(2) of Directive 98/83/EC shall remain applicable for second derogations that are still applicable on 12 January 2021.
Article 27 Entry into force
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Article 28 Addressees
This Directive is addressed to the Member States.