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 (recast) (Text with EEA relevance)
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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:
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;
methods for testing the effects on water quality, having regard to any relevant European standards;
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(1). 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(2), 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.
Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
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