Prováděcí rozhodnutí Komise (EU) 2024/367 ze dne 23. ledna 2024, kterým se stanoví prováděcí pravidla ke směrnici Evropského parlamentu a Rady (EU) 2020/2184 stanovením evropských seznamů povolených výchozích látek, směsí a složek, které jsou povoleny k použití při výrobě materiálů nebo výrobků přicházejících 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 (b), thereof,

This Decision establishes the following:

(a) the European positive list of starting substances for organic materials and groups of starting substances for organic materials as set out in Tables 1 and 2 of Annex I respectively;

(b) the European positive list of compositions of metallic materials and groups of compositions for metallic materials as set out in Tables 1 and 2 of Annex II respectively;

(c) the European positive list of organic constituents of cementitious materials and groups of organic constituents for cementitious materials as set out in Tables 2 and 3 of Annex III respectively;

(d) the European positive list of compositions of enamels, ceramic and other inorganic materials as set out in Table 1 of Annex IV.

OJ L 435, 23.12.2020, p. 1 .

(1) Directive (EU) 2020/2184 provides for the establishment of European positive lists of substances, compositions and constituents for each type of materials, namely organic, cementitious, metallic, enamels, ceramic or other inorganic materials, which are authorised for use in the manufacture of materials or products that come into contact with water intended for human consumption and fall within the scope of Article 11 of that Directive. These European positive lists should include, where appropriate, conditions for the use of substances, compositions and constituents and migration limits, which are to be determined on the basis of the methodologies adopted pursuant to Article 11(2), point (a), of Directive (EU) 2020/2184. Such conditions of use may include a purity criterion, a condition on the physico-chemical characteristics of the starting substance, composition or constituent, a condition on its manufacturing process or on the manufacturing process of final materials, their use for certain products, the use of these products, or further testing requirement. Sacrificial anodes, membranes and ions exchange resins are water treatment chemicals and/or filter media and are covered by Article 12 of Directive (EU) 2020/2184, therefore they are excluded from the scope of Article 11 of that Directive.

(2) Article 11(3) of the Directive sets out that lists established by the Commission pursuant to Article 5 of Regulation (EC) No 1935/2004 of the European Parliament and of the CouncilRegulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4 ). should be used as a source to establish the first European positive lists under the Directive. The list established in Annex I to Commission Regulation (EU) No 10/2011Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1 ). is one of these lists. However, substances included on this list have only been assessed for their use in plastic food contact materials in accordance with Regulation (EU) No 10/2011, subject to specific conditions of use. Moreover, the European Food Safety Authority has indicated that a significant number of the substances should be prioritised for re-evaluation as no specific migration limit was established when they were authorised for use in plastic food contact materialsEFSA CEP Panel (EFSA Panel on Food Contact Materials, Enzymes andProcessing Aids), Silano V, et. al., 2020. Scientific Opinion on the review and priority setting for substances that are listed without a specific migration limit in Table 1 of Annex 1 of Regulation 10/2011on plastic materials and articles intended to come into contact with food. EFSA Journal 2020;18(6):6124,104 pp. https://doi.org/10.2903/j.efsa.2020.6124. . The inclusion of such substances in Annex I to Regulation (EU) No 10/2011 nevertheless provides a much higher level of certainty over their safety in contact with drinking water when used in the manufacture of drinking water products, than would be the case for unlisted substances. Therefore it is appropriate to add substances originating from lists established by the Commission pursuant to Article 5 of Regulation (EC) No 1935/2004 to the first European list under Article 11(3) of the Directive, provided these

(3) Where applicable, the migration limit, i.e. the maximum tolerable concentration at the tap, should be based on the parametric value set out in Part B or C of Annex I to Directive (EU) 2020/2184 or the specific migration limit set out in Annexes I and II to Regulation (EU) No 10/2011. This should, however, be done after application of an allocation factor to account for the proportion of potential exposure from materials in contact with water intended for human consumption derived from the information provided by Member States.

(4) Annex I to Regulation (EU) No 10/2011 provides further detail on conditions of use of authorised substances, as well FCM substance reference numbers used in risk assessments. To facilitate further conformity assessment of substances that are added to the first European positive list on the basis of Annex I to Regulation (EU) No 10/2011, it is appropriate to add their FCM reference numbers in the first European positive lists.

(5) The expiry dates included in the first European positive lists follow the recommendation from European Chemicals Agency (ECHA) in particular on the basis of the hazardous properties of the starting substance, composition or constituent, the quality of the underlying risk assessments, the extent to which those risk assessments are up-to-date and the need for a staggered review of these entries.

(6) Some entries in the European positive lists should be allowed to be combined, extended to related starting substances, compositions and constituents or extended for use in different material types than the one for which they have been authorised when such combination or extension has no impact on the protection of human health to ensure the proportionality and efficiency of the process.

(7) Based on notifications from Member States, the first European positive lists include group entries covering multiple starting substances, compositions or constituents. Assessing the safety of each individual starting substance, composition or constituent separately is more appropriate to assess the safety of the groups; however, at the time of adopting the first European positive list it was not possible to identify the starting substances or organic cementitious constituents in those groups. Therefore, group entries should progressively be replaced in the European positive lists by the individual starting substances, compositions or constituents in the group and the economic operator should only be able to rely on such group entries for the first European positive list if it is able to demonstrate the safety of its starting substance, composition or constituent.

(8) In order to ensure an orderly and efficient application process, an entry may be renewed provided that notification of intention and, subsequently, an application is submitted to ECHA within a set deadline.

(9) Member States’ national provisions with regard to starting substances, compositions and constituents and their national positive lists were notified to ECHA by 12 July 2021 . In order to allow national authorities sufficient time to prepare for the application of the European positive lists, the application of this act will start from 31 December 2026 . The national systems are to apply until 31 December 2026 . In addition, transitional measures should be provided for substances, compositions and constituents approved in the national systems from 13 July 2021 to 31 December 2026 , provided that in accordance with Part B of Annex I to Directive (EU) 2020/2184, these substances do not exceed the parametric value of 5 μg/l for lead (Pb) at the tap.

(10) 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 purpose of this Decision, the following definitions shall apply:

Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4 ).

Article 1 Article 1 European positive lists

Article 2 Article 2 Definitions

Article 3 Article 3 Transitional provision

Article 4 Article 4 Entry into force

(1) 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;

(2) monomer means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process;

(3) organic material means a material that mainly consist of carbon-based substances;

(4) monomer unit means the reacted form of a monomer substance in a polymer;

(5) polymer means a substance consisting of molecules that are characterised by the sequence of one or more types of monomer units ant that are distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units comprising the following:(a) a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant;(b) less than a simple weight majority of molecules of the same molecular weight;

(a) a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant;

(b) less than a simple weight majority of molecules of the same molecular weight;

(6) polymerised part means the part of a substance composition consisting of molecules characterised by the sequence of one or more types of monomer units. Molecules such as dimers, trimers contribute also to the polymerised part. However, the term polymerised part does not cover unreacted monomer or unreacted other reactants;

(7) pre-polymer is a substance resulting from a polymerisation-type of reaction and that is further reacted into a final polymer in a material or product;

(8) organic cementitious constituent means an organic substance that is used in the manufacture of cementitious materials;

(9) cement means a finely ground inorganic material which, when mixed with water, forms a paste that sets and hardens by means of hydration reactions and processes and which, after hardening, retains its strength and stability even under water;

(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;

Starting substances, compositions and constituents which have been approved by a Member State competent authority during the period from 13 July 2021 to 31 December 2026 in accordance with national provisions may be used in the manufacture of materials or products that come into contact with water intended for human consumption until 31 December 2032 , provided they comply with the parametric value of 5 μg/l Pb (lead) at the tap as set out in Part B of Annex I to Directive (EU) 2020/2184.

Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1 ).

(11) non-intentionally added species means either one of the following:(a) an impurity of a starting substance or organic cementitious constituent or composition;(b) a reaction product or a degradation product of a starting substance or organic cementitious constituent that forms during the processing or use of the material;(c) a reaction product or a degradation product of a starting substance or organic cementitious constituent that forms in contact with water during the use of the material;

(a) an impurity of a starting substance or organic cementitious constituent or composition;

(b) a reaction product or a degradation product of a starting substance or organic cementitious constituent that forms during the processing or use of the material;

(c) a reaction product or a degradation product of a starting substance or organic cementitious constituent that forms in contact with water during the use of the material;

(12) metallic material means a metal or metal alloy used either in bulk form or as metallic plating;

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

(14) 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;

(15) maximum tolerable concentration at the tap (MTCtap ) means the maximum permitted concentration of a substance transferred from a specific material into water intended for human consumption.

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 .

EFSA CEP Panel (EFSA Panel on Food Contact Materials, Enzymes andProcessing Aids), Silano V, et. al., 2020. Scientific Opinion on the review and priority setting for substances that are listed without a specific migration limit in Table 1 of Annex 1 of Regulation 10/2011on plastic materials and articles intended to come into contact with food. EFSA Journal 2020;18(6):6124,104 pp. https://doi.org/10.2903/j.efsa.2020.6124.

HAS ADOPTED THIS DECISION: