Commission Implementing Decision (EU) 2024/365 of 23 January 2024 laying down rules for the application of Directive (EU) 2020/2184 of the European Parliament and of the Council as regards methodologies for testing and accepting starting substances, compositions and constituents to be included in the European positive lists

For the purpose of this Decision, the following definitions apply: (1) ‘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; (2) ‘nanoform’ means a form of a natural or manufactured substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm–100 nm, including also by derogation fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm. For the purpose of this definition: (a) ‘particle’ means a minute piece of matter with defined physical boundaries; (b) ‘aggregate’ means a particle comprising strongly bound or fused particles; (c) ‘agglomerate’ means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components; (3) ‘migration’ means transfer of substances from a material into water intended for human consumption.

1 The methodologies referred to in Article 11(2), point (a), of Directive (EU) 2020/2184 shall apply to the following: (a) starting substance for organic materials; (b) organic constituent of cementitious materials; (c) composition of metallic materials; (d) composition of enamels, ceramic and other inorganic materials.

2 Where a polymer is intended for use in an organic material or a cementitious material, the testing and acceptance methodologies shall be applied to the monomer, pre-polymer or polymer in accordance with the rules set out in points v to viii of Annex I and points iii and iv of Annex III to Commission Implementing Decision (EU) 2024/367 .

1 Starting substances, compositions and organic cementitious constituents shall be identified in accordance with the requirements set out in Annex I.

2 The intended use of starting substances, compositions, constituents, as well as materials and products shall be specified in accordance with the requirements set out in Annex II.

3 The physico-chemical properties of the relevant chemical species shall be determined in accordance with the requirements set out in Annex III.

4 Migration into water intended for human consumption shall be determined in accordance with the requirements set out in Annex IV.

5 The relevant chemical species shall be identified in accordance with Section 3 of Annex IV.

6 The toxicological properties of the relevant chemical species referred to in paragraph 5 shall be determined in accordance with the requirements set out in Annex V.

1 Starting substances, compositions and constituents shall be accepted in accordance with Annex VI on the basis of an assessment of the risks raised by the relevant chemical species identified for the corresponding starting substance, composition or organic cementitious constituent.

2 Starting substances and organic cementitious constituents which have a biocidal function and which are subject to Regulation (EU) No 528/2012 of the European Parliament and of the Council shall only be accepted if they belong to product-type 6 (preservatives for products during storage) as set out in Annex V to that Regulation.

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.