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)

‘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.’

‘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’

‘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.

4 For the evaluation of a substance containing more than one constituent pursuant to Chapter 2 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, 3.6, 3.7, 3.11 and 4.2 of Annex I, the manufacturer, importer and downstream user shall use the relevant available information referred to in paragraph 1 for each of the known constituents. 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.

5 For the evaluation of a substance containing more than one constituent pursuant to Chapter 2 of this Title in relation to the biodegradation, persistence, mobility and bioaccumulation properties within the “hazardous to the aquatic environment”, “persistent, bioaccumulative and toxic or very persistent, very bioaccumulative properties” and “persistent, mobile and toxic or very persistent, very mobile properties” hazard classes referred to in sections 4.1.2.8, 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I, the manufacturer, importer and downstream user shall use the relevant available information referred to in paragraph 1 for each of the known 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.

6 Paragraphs 4 and 5 shall not apply to substances containing more than one constituent which are extracted from plants or plant parts and which are not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006.

7 For the purpose of paragraph 6, “plants” refers to living or dead organisms from the kingdoms Plantae and Fungi, and includes algae, lichens and yeasts.

8 For certain substances containing more than one constituent that are not covered by paragraph 6, where the Commission receives evidence that the rules set out in paragraphs 4 or 5 might not be suitable for certain substances containing more than one constituent, the Commission may request the Agency to evaluate the available data. 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.’

‘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.

4 For the evaluation of mixtures pursuant to Chapter 2 of this Title in relation to the biodegradation, persistency, mobility and bioaccumulation properties within the “hazardous to the aquatic environment”, “persistent, bioaccumulative and toxic or very persistent, very bioaccumulative properties” and “persistent, mobile and toxic or very persistent, very mobile properties” hazard classes referred to in sections 4.1.2.8, 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 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.’

‘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.

4 When evaluating hazard information for mixtures, manufacturers, importers and downstream users shall, where test data for the mixture itself are inadequate or unavailable, apply the bridging principles referred to in section 1.1.3 of Annex I and in each section of Parts 3 and 4 of that Annex for the purposes of the evaluation. 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.’

1 Specific concentration limits and generic concentration limits are limits assigned to a substance indicating a threshold at or above which the presence of that substance in another substance or in a mixture as an identified impurity, additive or individual constituent leads to the classification of the substance or mixture as hazardous. 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.

2 Manufacturers, importers and downstream users shall establish M-factors for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1.

3 Manufacturers, importers and downstream users shall establish acute toxicity estimates for substances classified as acutely toxic for human health.

4 By way of derogation from paragraph 1, second and third subparagraphs, specific concentration limits shall not be set for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI.

5 By way of derogation from paragraph 2, M-factors shall not be established for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI for which an M-factor is given in that Part. 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.

6 By way of derogation from paragraph 3, acute toxicity estimates shall not be established for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI for which an acute toxicity estimate is given in that Part.

7 When setting the specific concentration limit, M-factor or acute toxicity estimate, manufacturers, importers and downstream users shall take into account any specific concentration limits, M-factors or acute toxicity estimate for that substance which have been included in the classification and labelling inventory.

8 Specific concentration limits set in accordance with paragraph 1, second and third subparagraphs, shall take precedence over the concentration limits set out in the relevant sections of Part 2 of Annex I or the generic concentration limits for classification set out in the relevant sections of Parts 3, 4 and 5 of that Annex.

9 The Agency shall provide further guidance for the application of paragraphs 1, 2 and 3.

10 Where a mixture contains a substance which is classified as hazardous solely due to the presence of an identified impurity, additive or individual constituent, the concentration limits referred to in paragraph 1, second and third subparagraphs, shall apply to the concentration of that identified impurity, additive or individual constituent in the mixture.

11 Where a mixture contains another mixture, the concentration limits referred to in paragraph 1, second and third subparagraphs, shall apply to the concentration of the identified impurity, additive or individual constituent referred to in paragraph 10 in the resulting final mixture.’

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).’

1 In the event of a change regarding the classification or labelling of a substance or a mixture, which results in the addition of a new hazard class or in a more severe classification, or which requires new supplemental information on the label in accordance with Article 25, the supplier of that substance or that mixture shall ensure that the label is updated without undue delay and in any event no later than 6 months after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.

2 Where a change regarding the classification or labelling of a substance or a mixture, other than those referred to in paragraph 1 of this Article, is required, the supplier of that substance or that mixture shall ensure that the label is updated without undue delay and in any event no later than 18 months after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.

3 Paragraphs 1 and 2 shall not apply where a change regarding the classification and labelling of a substance or a mixture was triggered by a harmonised classification and labelling of a substance set out in a delegated act adopted pursuant to Article 37(5) or by a provision set out in a delegated act adopted pursuant to Article 53(1). In such cases, the supplier shall ensure that the label is updated by the date set out in the respective delegated act.

4 The supplier of a substance or mixture that falls within the scope of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 shall update the label in accordance with those Regulations’

1 The label elements for substances and mixtures referred to in Article 17 shall be provided on a label in a physical form (“physical label”). In addition to the physical label, the label elements referred to in Article 17 may be provided in a digital form (“digital label”).

2 By way of derogation from paragraph 1, suppliers may provide the label elements set out in section 1.6 of Annex I on a digital label only. Where the label elements set out in section 1.6 of Annex I are provided on a digital label only, suppliers shall, upon oral or written request or when the digital label is temporarily unavailable at the time of purchase of the substance or mixture, provide those label elements by alternative means. Suppliers shall provide those elements independently of a purchase and free of charge.

3 Where the information is provided through a digital label, the requirements for digital labels set out in Article 34b shall apply.

1 Where, pursuant to Article 31(1b), a supplier affixes or prints a data carrier linking to a digital label, that supplier shall ensure that the digital label satisfies the following general rules and technical requirements: (a) all label elements referred to in Article 17(1) shall be provided together in one place and separately from other information; (b) the information on the digital label shall be searchable; (c) the information on the digital label shall be accessible to all users in the Union and shall remain accessible for a period of at least 10 years or for a longer period where required by other Union legislation; (d) the digital label shall be accessible free of charge, without the need to register or to download or install applications, or to provide a password; (e) the information on the digital label shall be presented in a way that also addresses the needs of vulnerable groups and supports, as relevant, the necessary adaptations to facilitate access to the information by those groups; (f) the information on the digital label shall be accessible with no more than two clicks; (g) the digital label shall be accessible through digital technologies widely used, and compatible with all major operating systems and browsers; (h) where the information on the digital label is accessible in more than one language, the choice of language shall not be conditioned by the geographical location from which that information is accessed.

2 It shall be prohibited to track, analyse or use any usage information for purposes going beyond what is absolutely necessary for the provision of digital labelling.’

1 Any advertisement for a substance classified as hazardous shall indicate, as applicable, the hazard pictograms, signal words, hazard statements and supplemental EUH statements set out in Annex II. Any advertisement for such a substance for sale to the general public shall in addition state: “Always follow the information on the product label.”.

2 Any advertisement for a mixture classified as hazardous or covered by Article 25(6) shall indicate the hazard pictograms, signal words, hazard statements and supplemental EUH statements set out in Annex II. Any advertisement for such a mixture for sale to the general public shall, in addition, state: “Always follow the information on the product label.”.

3 Any advertisement for a substance or a mixture classified as hazardous shall not contain statements that are not to appear on the label or packaging of that substance or mixture in accordance with Article 25(4).

4 By way of derogation from paragraphs 1 and 2, the hazard pictograms and signal words may be omitted where the advertisement is non-visual.’

When substances or mixtures are placed on the market through distance sales, the offer shall clearly and visibly indicate the label elements referred to in Article 17.’

The Commission shall adopt a separate delegated act in respect of each power delegated to it pursuant to this Regulation, with the exception of the powers delegated pursuant to Article 37(5) and Article 53(1) to amend Annex VI, where Parts 1 and 2 of that Annex may be amended together with Part 3 of that Annex in one single act.’

1 By 11 December 2029, the Commission shall present a scientific report to the European Parliament and to the Council regarding the examination of the information on substances containing more than one constituent extracted from plants. The report may be accompanied, if appropriate, by a legislative proposal.

2 By 11 December 2029, the Commission shall present an evaluation report to the European Parliament, the Council and the European Economic and Social Committee, assessing the need to extend requirements in sections 3.1 and 3.2 of Annex II on child-resistant fastenings and tactile warnings to other hazard classes. If justified by the results of the report, the Commission shall act in accordance with Article 53(1).’

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

2 Article 1, point (3)(b), Article 1, points (4) to (7), Article 1, point (12)(a), Article 1, points (13) and (14), Article 1, points (15)(a) and (b), Article 1, points (17), (18), (22), (23), (26) and (27), points (4), (8), (10) and (11) of Annex I and Annex II shall apply from 1 July 2026.

3 Article 1, point (1), Article 1, point (9), Article 1, point (15)(c), Article 1, points (24)(b) and (d), points (2) and (3) of Annex I and Annex IV shall apply from 1 January 2027.

4 By way of derogation from Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 10, Article 25(3), Articles 29, Article 30, Article 31(1), Article 35, Article 40(1) and (2), Article 42(1), third subparagraph and Article 48 of Regulation (EC) No 1272/2008, section 1.2.1, section 1.5.1.2 and section 1.5.2.4.1 of Annex I and Parts 3 and 5 of Annex II to Regulation (EC) No 1272/2008 as applicable on 9 December 2024, substances and mixtures may until 30 June 2026 be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by Article 1, points (4) to (7), Article 1, point (12)(a), Article 1, points (13), (14), Article 1, point (15)(a) and b), Article 1, points (18), (22), Article 1, point (23)(a) and Article 1, point (26), points (4), (8) and (10) of Annex I and Annex II to this Regulation.

5 By way of derogation from Article 1(1), 18(3)(b), Article 31(3), Article 45(1) and (3) of Regulation (EC) No 1272/2008 and section 1.2.1 of Annex I, part A, section 1 of Annex VIII, part A, section 2.1, of Annex VIII, part A, the first subparagraph of section 2.4 of Annex VIII, Part B, section 1 of Annex VIII, Part B, the third paragraph of section 3.1 of Annex VIII, Part B, section 3.6 of Annex VIII, Part B, the first row of Table 3 of section 3.7 of Annex VIII, Part B, the first paragraph of section 4.1 of Annex VIII, Part C, sections 1.2 and 1.4 of Annex VIII, and Part D, sections 1, 2 and 3 of Annex VIII to Regulation (EC) No 1272/2008 as applicable on 9 December 2024, substances and mixtures may until 31 December 2026 be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by Article 1, points (1) and (9), Article 1, point (15)(c), Article 1, point (24)(b) and (d) of this Regulation, points (2) and (3) of Annex I and Annex IV to this Regulation.