Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (Text with EEA relevance)

Article 1

Regulation (EC) No 1272/2008 is amended as follows:

(1) in Article 1(1), the following point is added: ‘(f) providing an obligation for downstream users, importers and distributors referred to in Article 45(1b) and (1c) to submit information relevant to an adequate emergency health response to appointed bodies in accordance with Annex VIII.’ ;

(2) in Article 2, the following points are added: ‘38. “acute toxicity estimates” means numeric values which are used to classify substances and mixtures in one of four acute toxicity hazard categories based on the oral, dermal or inhalation exposure route.’;

(3) Article 4 is amended as follows: (a) paragraph 3 is replaced by the following: ‘3. If a substance is subject to harmonised classification and labelling in accordance with Title V, through an entry in Part 3 of Annex VI, that substance shall be classified in accordance with that entry, and a classification of that substance in accordance with Title II shall not be carried out for the hazard classes, differentiations, or forms or physical states covered by that entry. The harmonised classification of that substance shall apply to all its forms or physical states unless an entry in Part 3 of Annex VI specifies that a harmonised classification applies to a specific form or physical state of that substance. However, where the substance also falls within one or more hazard classes or differentiations or it is in a form or physical state not covered by an entry in Part 3 of Annex VI, its classification in accordance with Title II shall be carried out for those hazard classes, differentiations and forms or physical states.’ ; (b) the following paragraph is added: ‘11. A substance or a mixture shall not be placed on the market unless a supplier established in the Union, which shall be identified on the label, in the course of an industrial or professional activity fulfils the requirements set out in this Regulation with regard to the substances or mixture in question’ ;

(4) in Article 5, is amended as follows: (a) in paragraph 1, the following point is inserted: ‘ca) data obtained from new approach methodologies;’ ; (b) the following paragraphs are added: ‘3. A substance containing more than one constituent, in the form of an individual constituent, an identified impurity or an additive, for which relevant information referred to in paragraph 1 is available, shall be evaluated using the available information on those known constituents as well as on the substance itself.

Relevant available information on a substance containing more than one constituent itself shall be taken into account where one of the following conditions is met: (a) the information demonstrates germ cell mutagenic, carcinogenic, or toxic to reproduction properties, or endocrine disruption for human health or the environment; (b) the information supports the conclusions based on the relevant available information on the constituents in the substance. Relevant available information on the substance containing more than one constituent itself demonstrating an absence of the properties referred to in point (a) or less severe properties shall not override the relevant available information on the constituents in the substance.

Relevant available information on a substance containing more than one constituent itself shall be taken into account where one of the following conditions is met: (a) the information demonstrates persistence, mobility and bioaccumulation properties or a lack of degradation. (b) the information supports the conclusions based on the relevant available information on the constituents in the substance. Relevant available information on the substance containing more than one constituent itself demonstrating an absence of the properties referred to in point (a) or less severe properties shall not override the relevant available information on the constituents in the substance.

The Commission is empowered to adopt delegated acts in accordance with Article 53a to amend Annex I by creating a new section and by including and modifying, in that section, the derogations from paragraph 4 or 5 on classification of substances containing more than one constituent. For those delegated acts, the Commission shall take into account scientific evidence, advances in knowledge, and the opinion of the Agency when available, to appropriately classify substances containing more than one constituent provided that a high level of protection of human health and the environment is ensured.’ ;

(5) in Article 6 is amended as follows: (a) in paragraph 1, the following point is inserted: ‘ca) data obtained from new approach methodologies;’ ; (b) paragraphs 3 and 4 are replaced by the following: ‘3. For the evaluation of mixtures pursuant to chapter 2 of this Title in relation to the “germ cell mutagenicity”, “carcinogenicity”, “reproductive toxicity”, “endocrine disruption for human health” and “endocrine disruption for the environment” hazard classes referred to in sections 3.5.3.1, 3.6.3.1, 3.7.3.1, 3.11.3.1 and 4.2.3.1 of Annex I, the manufacturer, importer and downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture and not for the mixture itself. Where the available test data on the mixture itself demonstrate germ cell mutagenic, carcinogenic or toxic to reproduction properties, or endocrine disruption for human health or the environment which have not been identified from the relevant available information on the individual substance referred to in the first subparagraph, those data shall also be taken into account for the purposes of the evaluation of the mixture referred to in the first subparagraph.

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(6) in Article 9, paragraphs 3 and 4 are replaced by the following: ‘3. Where the criteria referred to in paragraph 1 cannot be applied directly to available identified information, manufacturers, importers and downstream users shall carry out an evaluation by applying a weight of evidence determination using expert judgement in accordance with section 1.1.1 of Annex I to this Regulation, weighing all available information having a bearing on the determination of the hazards of the substance or the mixture, and in accordance with section 1.2 of Annex XI to Regulation (EC) No 1907/2006.

If more than one similar tested mixture is available when applying the bridging principles, manufacturers, importers and downstream users shall apply a weight of evidence determination using expert judgement in accordance with section 1.1.1 of Annex I to this Regulation, weighing all available information having a bearing on the determination of the hazards of the mixture, and in accordance with section 1.2 of Annex XI to Regulation (EC) No 1907/2006, to select the most suitable similar tested mixtures in accordance with Article 6(5) of this Regulation for their decision on classification. When evaluating the hazard information for mixtures, manufacturers, importers and downstream users shall, where that information does not permit the application of the bridging principles in accordance with the first and second subparagraphs, evaluate the information by applying the other method or methods set out in Parts 3 and 4 of Annex I.’ ;

(7) Article 10 is replaced by the following: ‘Article 10 Concentration limits, M-factors and acute toxicity estimates for classification of substances and mixtures

Specific concentration limits shall be set by the manufacturer, importer or downstream user where adequate and reliable scientific information shows that the hazard of a substance is evident when that substance is present at a level below the concentrations set for any hazard class in Part 2 of Annex I or below the generic concentration limits set for any hazard class in Parts 3, 4 and 5 of Annex I. Manufacturers, importers and downstream users may set a specific concentration limit for a substance in exceptional circumstances where adequate, reliable and conclusive scientific information shows that the hazard of a substance classified as hazardous is not evident at a level above the concentrations set for the relevant hazard class in Part 2 of Annex I or above the generic concentration limits set for the relevant hazard class in Parts 3, 4 and 5 of that Annex.

However, where an M-factor is not given in Part 3 of Annex VI for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1, the manufacturer, importer or downstream user shall set an M-factor based on available data for the substance. When a mixture including the substance is classified by the manufacturer, importer or downstream user using the summation method, that M-factor shall be used.

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(8) Article 13 is replaced by the following: ‘Article 13 Decision to classify substances and mixtures If the evaluation undertaken pursuant to Articles 9 and 12 shows that the hazards associated with the substance or mixture meet the criteria for classification in one or more hazard classes or differentiations in Parts 2 to 5 of Annex I, manufacturers, importers and downstream users shall classify the substance or mixture or, if scientifically justified, specific forms or physical states thereof, in relation to the relevant hazard class or classes or differentiations by assigning the following: (a) one or more hazard categories for each relevant hazard class or differentiation; (b) subject to Article 21, one or more hazard statements corresponding to each hazard category assigned in accordance with point (a).’ ;

(9) in Article 18(3), point (b) is replaced by the following: ‘(b) the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity, aspiration hazard, persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic, very persistent and very mobile properties, or endocrine disruption for human health or the environment.’ ;

(10) in Article 23, the following point is added: ‘(g) ammunition as defined in Article 1(1), point (3), of Directive (EU) 2021/555 of the European Parliament and of the Council (^*1) unless it is an article that falls within the scope of Article 4(8) of this Regulation.