Commission Implementing Decision (EU) 2024/367 of 23 January 2024 laying down rules for the application of Directive (EU) 2020/2184 of the European Parliament and of the Council by establishing the European positive lists of starting substances, compositions and constituents authorised for use in the manufacture of materials or products that come into contact with water intended for human consumption

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.

For the purpose of this Decision, the following definitions shall apply: (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; (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; (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; (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; (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.

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.

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.