Prováděcí rozhodnutí Komise (EU) 2024/368 ze dne 23. ledna 2024, kterým se stanoví prováděcí pravidla ke směrnici Evropského parlamentu a Rady (EU) 2020/2184, pokud jde o postupy a metody pro zkoušky a schvalování konečných materiálů používaných ve výrobcích, které přicházejí do kontaktu s vodou určenou k lidské spotřebě

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumptionOJ L 435, 23.12.2020, p. 1 . , and in particular Article 11(2), point (c), thereof,

The procedures and methods for testing and accepting final materials as used in a product as provided for in Article 11(2), point (c), of Directive (EU) 2020/2184 on the quality of water intended for human consumption are set out in the Annexes I to IV.

OJ L 435, 23.12.2020, p. 1 .

(1) In order to be able to test and accept final materials to be used in products that come into contact with water intended for human consumption, hygiene requirements should be set out for each category of final material, namely organic, cementitious, metallic, enamels and ceramic, or other inorganic materials. The methodologies to be used should be based, inter alia , on Annex V to Directive (EU) 2020/2184 and should be taken into account in the performance of the conformity assessment procedures of products.

(2) The testing of final materials requires the identification of relevant substances and other relevant parameters. Those substances and parameters should be analysed in the migration water. It is necessary to establish the requirements for such testing procedure and analysis.

(3) This Decision should lay down the testing requirements in order to ensure the performance of the testing. For organic, cementitious, enamel and ceramic materials, the testing requirements should be subject to a risk-based approach by categorising the product that comes into contact with water intended for human consumption. The risk-based approach ensures proportionate testing in relation to the human health risk of the final material.

(4) The testing for each final material should be carried out in accordance with the determined testing requirements to ensure that the water intended for human consumption is wholesome and clean. In order to determine whether the final material should be accepted and approved, it is necessary to set out pass/fail criteria that the results of the testing have to meet.

(5) In order to ensure proportionate testing, it should be possible to reduce testing for materials used in minor components and minor components of assembled products.

(6) National competent authorities or bodies should be allowed sufficient time to adapt their national system to the new requirements for testing and acceptance of final materials. The application of this Decision should therefore be deferred.

(7) The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 22(1) of Directive (EU) 2020/2184.

For the purposes of this Decision, the following definitions apply:

Article 1 Article 1

Article 2 Article 2 Definitions

Article 3 Article 3

(1) starting substance means a substance that has been intentionally added in the production of organic materials or of admixtures for cementitious materials;

(2) constituent means: any of the following:(a) a substance that has been intentionally used to manufacture a cementitious material;(b) an alloying element present in a composition of metallic materials;(c) an element or a combination of elements present in a composition of enamels, ceramic or other inorganic materials;(d) a substance present in a mixture of substances.

(a) a substance that has been intentionally used to manufacture a cementitious material;

(b) an alloying element present in a composition of metallic materials;

(c) an element or a combination of elements present in a composition of enamels, ceramic or other inorganic materials;

(d) a substance present in a mixture of substances.

(3) product means an object that comes into contact with water intended for human consumption, which is made of final materials and with the intention to be placed on the market;

(4) assembled product means a product that consists of two or more components, that are joined together and function as a whole unit and can be disassembled without destroying the components;

(5) component means an identifiable part of an assembled product consisting of one or more materials;

(6) multilayer product means a product that consist of two or more layers of final materials bonded together and cannot be non-destructively disassembled for the testing;

(7) material means a solid, semi-solid or liquid that is used for the manufacturing of a product that is:(a) an organic composition prepared from one or more starting substances; or(b) a cementitious composition prepared from one or more constituents; or(c) a metallic, enamel, ceramic or other inorganic composition.

(a) an organic composition prepared from one or more starting substances; or

(b) a cementitious composition prepared from one or more constituents; or

(c) a metallic, enamel, ceramic or other inorganic composition.

(8) organic material means a material that mainly consists of carbon-based substances;

(9) metallic material means a metal or metal alloy, and that is used either in bulk form or as metallic plating;

(10) cementitious material means a material that contains a hydraulic cement in sufficient proportion to act as the main binder by forming a hydrate structure which governs the performance of the material;

This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

It shall apply from 31 December 2026 .

(11) enamel means a material that is a vitreous material obtained by melting at temperatures higher than 1200 °C and fritting of a mixture of inorganic substances;

(12) ceramic material means inorganic poly or single crystalline, non-metallic solid materials subjected to high temperature in manufacture;

(13) final material means a material which is subject to testing and acceptance in accordance with the testing requirements and acceptance requirements set out in the respective Annexes I, II, III and IV to this Decision;

(14) site applied material means a final material to be produced on a construction site;

(15) test piece means a representative object of the final material that is used for the carrying out of testing in accordance with the procedures and methods for testing set out in the respective Annexes I, II, III and IV of this Decision;

(16) unexpected substance means a substance that has migrated from a product, a final organic material or a final cementitious material into water intended for human consumption, that was not intentionally added during the production process of the material or product, and that was not included in the information provided in the application referred to in Article 11(5) of Directive (EU) 2020/2184;

(17) formulation means the list of all substances or constituents used in the preparation of an organic material or of a cementitious material and their relative quantities;

(18) total barrier means a barrier layer that prevents the diffusion of any substances towards the side of the final material in contact with the water intended for human consumption;

(19) enhancement of microbial growth (EMG) means the ability of final organic or cementitious materials to enhance the multiplication of micro-organisms under specified conditions;

(20) migration water means the test water that has been in contact with the test piece under the specified conditions set out in the respective Annexes I, II, III and IV.

HAS ADOPTED THIS DECISION: