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.’;
• 1. “data carrier” means a linear bar code symbol, a two-dimensional symbol or other automatic identification data capture medium that can be read by a device;
• 1. “refill” means an operation by which a consumer or a professional user fills packaging with a hazardous substance or mixture offered by a supplier in the course of a commercial activity, whether in return for payment or free of charge;
• 1. “refill station” means a place where a supplier offers to consumers or professional users hazardous substances or mixtures that can be acquired through refill, either manually or through automatic or semi-automatic equipment.;’

• (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.

;

• (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.

;

• (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 ([^E0001]) unless it is an article that falls within the scope of Article 4(8) of this Regulation.

• (11) in Article 24(2), the second subparagraph is replaced by the following: ‘The level of the fees shall be determined by the Commission by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 54(2) of this Regulation.’

• (12) Article 25 is amended as follows:
• (a) paragraph 3 is replaced by the following: ‘3. The supplier may include supplemental information in the section for supplemental information on the label other than that referred to in paragraphs 1, 2 and 6 to 9, provided that that information does not make it more difficult to identify the label elements referred to in Article 17(1), points (a) to (g), and that it provides further details and does not contradict or cast doubt on the validity of the information specified by those elements.’ ;
• (b) in paragraph 6, the first subparagraph is replaced by the following: ‘The special labelling rules set out in Part 2 of Annex II shall apply to mixtures containing substances referred to in Part 2 of that Annex.’
• (c) the following paragraph is added: ‘9. Label elements resulting from requirements set out in other Union acts shall be placed in the section for supplemental information on the label.’ ;

• (13) Article 29 is amended as follows:
• (a) paragraph 1 is replaced by the following: ‘1. Where the packaging of a substance or a mixture is either in such a shape or form or is so small that it is impossible to meet the requirements laid down in Article 31 for a label in the languages of the Member State in which the substance or mixture is placed on the market, the label elements set out in Article 17(1), shall be provided in accordance with section 1.5.1 of Annex I.’ ;
• (b) paragraph 3 is replaced by the following: ‘3. Where a hazardous substance or mixture referred to in Part 5 of Annex II is supplied to the general public without packaging, the labelling information shall be provided in accordance with the provision referring to that substance or mixture in that Part.’ ;
• (c) the following paragraph is added: ‘4b. By way of derogation from Article 17(1), the labelling requirement set out in that Article shall not apply to packaging of ammunition that is intended for use by defence forces, where labelling in accordance with that requirement would constitute an unacceptable security risk for the ammunition or for the military or non-military staff, and sufficient camouflaging cannot be ensured. In the case referred to in the first subparagraph of this paragraph, manufacturers, importers and downstream users shall provide to the defence forces the safety data sheet or, if no safety data sheet is required, a copy of the label elements as provided for in Article 17.’ ;

• (14) Article 30 is replaced by the following: ‘Article 30 Updating information on labels

;

• (15) Article 31 is amended as follows:
• (a) paragraph 1 is replaced by the following: ‘1. Labels shall be firmly affixed to one or more surfaces of the packaging immediately containing the substance or mixture and shall be readable horizontally when the package is set down normally. The label may be presented in the form of a fold-out label.’ ;
• (b) the following paragraphs are inserted: ‘1a. Where the label is presented in the form of a fold-out label, the label elements referred to in Article 17(1) shall be presented in accordance with section 1.2.1.6 of Annex I. 1b. Where a digital label as provided for in Article 34a(1) is used, a data carrier linking to that digital label shall be firmly affixed or printed on the physical label or on the packaging next to the label in such a way that it can be processed automatically by digital devices that are widely used. Where label elements are provided on a digital label only pursuant to Article 34a(2), the data carrier shall be accompanied by the statement “More hazard information available online” or by a similar indication.’ ;
• (c) paragraph 3 is replaced by the following: ‘3. The label elements referred to in Article 17(1) shall be clearly and indelibly marked. They shall stand out clearly from the background and they shall be of such a size and be spaced in such a way as to be easily read. They shall be formatted in accordance with section 1.2.1 of Annex I.’ ;

• (16) in Article 32, paragraph 6 is deleted;

• (17) in Title III, the following chapter is added: ‘Chapter 3 Labelling formats

Article 34a

Physical and digital labelling

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.

Article 34b

Requirements for digital labelling

(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.

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• (18) in Article 35, the following paragraph is added: ‘2a. Hazardous substances or mixtures may be supplied to consumers and professional users via refill stations only if the conditions laid down in section 3.4 of Annex II are fulfilled. The first subparagraph shall not apply to hazardous substances or mixtures supplied to the general public without packaging in accordance with Article 29(3).’ ;

• (19) in Article 36, paragraph 1 is amended as follows:
• (a) point (a) is replaced by the following:
• ‘(a) respiratory sensitisation, category 1, 1A or 1B (Annex I, section 3.4)’ ;
• (b) the following points are added:
• ‘(e) endocrine disruption for human health, category 1 or 2 (Annex I, section 3.11);
• (f) endocrine disruption for the environment, category 1 or 2 (Annex I, section 4.2);
• (g) persistent, bioaccumulative and toxic (Annex I, section 4.3);
• (h) very persistent, very bioaccumulative (Annex I, section 4.3);
• (i) persistent, mobile and toxic (Annex I, section 4.4);
• (j) very persistent, very mobile (Annex I, section 4.4)’ ;
• (c) paragraph 2 is replaced by the following: ‘2. Substances that are active substances falling within the scope of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 shall be subject to harmonised classification and labelling. For such substances, the procedures set out in Article 37(1), (4), (5) and (6) shall apply.’ ;

• (20) Article 37 is amended as follows:
• (a) paragraph 1 is replaced by the following: ‘1. A competent authority may submit to the Agency a proposal for harmonised classification and labelling of a substance or a group of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for a revision thereof. The Commission may request the Agency or the European Food Safety Authority (the “Authority”) established in accordance with Article 1(2) of Regulation (EC) No 178/2002 to prepare a proposal for harmonised classification and labelling of a substance or a group of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof. The Commission may subsequently submit the proposal to the Agency. The proposals for harmonised classification and labelling of a substance or a group of substances referred to in the first and the second subparagraphs shall follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.’ ;
• (b) the following paragraphs are inserted: ‘1a. Whenever considered scientifically justified and possible by a competent authority or the Commission, proposals for harmonised classification and labelling shall aim to prioritise groups of substances rather than individual substances. 1b. The Agency and the Authority may, on their own initiative, provide scientific advice to the competent authorities and the Commission indicating that a harmonised classification and labelling of a substance or a group of substances would be appropriate.’ ;
• (c) in paragraph 2, the first subparagraph is replaced by the following: ‘Manufacturers, importers and downstream users may submit to the Agency a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, provided that there is no entry in Part 3 of Annex VI for such substances in relation to the hazard class or differentiation covered by that proposal.’
• (d) the following paragraph is inserted: ‘2a. Before submitting a proposal to the Agency, a competent authority, manufacturer, importer or downstream user shall notify the Agency of its intention to submit a proposal for harmonised classification and labelling. Where the Commission has requested the preparation of a proposal pursuant to paragraph 1, second subparagraph, it shall notify the Agency of that request. Within one week of receipt of the notification referred to in the first and the second subparagraphs, the Agency shall publish the name and, where relevant, the EC and CAS numbers of the substance or substances, the status of the proposal and the name of the submitter. The Agency shall update the information on the status of the proposal after completion of each stage of the process referred to in paragraphs (4) and (5). Where a competent authority receives a proposal in accordance with paragraph 6, it shall notify the Agency and provide any relevant information on its reason for accepting or refusing the proposal. The Agency shall share that information with the other competent authorities.’ ;
• (e) paragraph 3 is replaced by the following: ‘3. Where the proposal of the manufacturer, importer or downstream user concerns the harmonised classification and labelling of substances in accordance with Article 36(3), it shall be accompanied by the fee determined by the Commission by means of implementing act adopted in accordance with the examination procedure referred to in Article 54(2).’ ;
• (f) paragraphs 5 and 6 are replaced by the following: ‘5. Where the Commission finds that the harmonisation of the classification and labelling of the substance concerned is appropriate, it shall adopt without undue delay, and preferably before the end of the calendar year following the publication of the opinion of the Committee for Risk Assessment, delegated acts in accordance with Article 53a to amend Annex VI by including substances together with the relevant classification and label elements and, where appropriate, the specific concentration limits, M-factors or acute toxicity estimates in Table 3 of Part 3 of Annex VI. Where, in the case of harmonisation of classification and labelling of substances, imperative grounds of urgency so require, the procedure provided for in Article 53b shall apply to delegated acts adopted pursuant to this paragraph.

; - (g) the following paragraphs are inserted: ‘7. In order to avoid duplication of assessment of hazardous properties of substances, the Commission is empowered to adopt delegated acts in accordance with Article 53a to amend Table 3 of Part 3 of Annex VI to this Regulation to: (a) include substances by 11 June 2026 as endocrine disruption for human health category 1, as endocrine disruption for the environment category 1, as persistent, bioaccumulative and toxic, or as very persistent, very bioaccumulative, together with relevant classification and label elements on the basis of respective criteria where by 11 June 2025, those substances: (i) have been included in the candidate list referred to in Article 59(1) of Regulation (EC) No 1907/2006 as having endocrine-disrupting properties for human health or the environment, as persistent, bioaccumulative and toxic or as very persistent and very bioaccumulative, (ii) have been identified as having endocrine-disrupting properties in accordance with section 3.6.5 or section 3.8.2 of Annex II to Regulation (EC) No 1107/2009, or as persistent, bioaccumulative and toxic or as very persistent and very bioaccumulative in accordance with section 3.7.2 or 3.7.3 of Annex II to that Regulation and a decision on the application for approval or the renewal of approval of those substances has been adopted under that Regulation; (iii) have been identified as having endocrine-disrupting properties in accordance with Article 1 of Delegated Regulation (EU) 2017/2100, or as persistent, bioaccumulative and toxic or as very persistent and very bioaccumulative in accordance with Article 5(1), point (e), of Regulation (EU) No 528/2012 and a decision on the application for approval or renewal of approval of those substances has been adopted under Regulation (EU) No 528/2012; and (b) include substances in Table 3 of Part 3 of Annex VI as endocrine disruption for human health category 1, as endocrine disruption for the environment category 1, as persistent, bioaccumulative and toxic, or as very persistent, very bioaccumulative, together with relevant classification and label elements on the basis of the respective criteria where: (i) those substances have been included in the candidate list referred to in Article 59 of Regulation (EC) No 1907/2006 before 11 June 2026 as having one of the properties mentioned in the introductory part and for which a dossier as provided for in Annex XV to that Regulation was under assessment by 11 June 2025; (ii) a decision on the application for approval or the renewal of approval of those substances identified as having one of the properties mentioned in the introductory part has been adopted under Regulation (EC) No 1107/2009 before 11 June 2032 and an application for approval or renewal of approval of those substances in accordance with the relevant provisions of that Regulation was submitted before 11 June 2025; (iii) a decision on the application for approval or the renewal of approval of those substances identified as having one of the properties mentioned in the introductory part has been adopted under Regulation (EU) No 528/2012 before 11 June 2030 and where, by 11 June 2025: — the evaluating competent authority has submitted its draft assessment report on the application for approval or renewal of approval to the Agency in accordance with the relevant provisions of Regulation (EU) No 528/2012; — the application was submitted for the purposes of Directive 98/8/EC and the Member State evaluation in accordance with that Directive was completed by 1 September 2013, but no decision on the application for approval or renewal of approval was adopted before that date; or — the Agency has submitted to the Commission an opinion pursuant to Article 75(1), point (g), of Regulation (EU) No 528/2012 following a request to establish whether the respective criteria are met.

;

• (21) in Article 38(1), point (c) is replaced by the following:
• ‘(c) the specific concentration limits, M-factors or acute toxicity estimates, where applicable;’ ;

• (22) Article 40 is amended as follows:
• (a) in paragraph 1, the first subparagraph is amended as follows:
• (i) point (e) is replaced by the following:
• ‘(e) specific concentration limits, M-factors or acute toxicity estimates, where applicable, in accordance with Article 10 of this Regulation, together with a justification as referred to in the relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006;’ ;
• (ii) the following points are added:
• ‘(g) where applicable, the reason for divergence from the most severe classification per hazard class included in the inventory referred to in Article 42;
• (h) where applicable, the reason for introducing a more severe classification per hazard class compared to those included in the inventory referred to in Article 42.’ ;
• (iii) the second subparagraph is replaced by the following: ‘The information referred to in points (a) to (h) shall not be notified, if it has been submitted to the Agency as part of a registration pursuant to Regulation (EC) No 1907/2006, or if it has already been notified by that notifier.’
• (b) paragraph 2 is replaced by the following: ‘2. The information listed in paragraph 1 shall be notified to the Agency by the notifier concerned at the latest 6 months after a decision to change the classification and labelling of the substance has been taken pursuant to the review referred to in Article 15(1).’ ;

• (23) Article 42 is amended as follows:
• (a) in paragraph 1, the third subparagraph is replaced by the following: ‘The Agency shall make the following information publicly available online and free of charge:
• (a) the information referred to in Article 40(1), point (a);
• (b) the identity of the importer or manufacturer submitting the information on behalf of the other members of the group, in the case of group notifications;
• (c) information in the inventory which corresponds to the information referred to in Article 119(1) of Regulation (EC) No 1907/2006;
• (d) the date of the latest update of the classification and labelling. Information referred to in Article 40(1), point (a), shall be made publicly available except where a notifier duly justifies why such publication is potentially harmful for its commercial interests or the commercial interests of any other concerned party. The Agency shall provide information on legitimate grounds on which confidentiality claims may be made. The Agency shall take measures to identify undue confidentiality claims, including automated screening and random manual checks.’ ;
• (b) the following paragraph is added: ‘3a. Where the Agency considers that an entry is incomplete, incorrect or obsolete it shall request the notifier to notify the correct entry.’ ;

• (24) Article 45 is amended as follows:
• (a) paragraph 1 is replaced by the following: ‘1. Member States shall appoint a body or bodies responsible for receiving the relevant harmonised information relating to emergency health response and preventative measures, in accordance with Annex VIII.’ ;
• (b) the following paragraphs are inserted: ‘1a. Member States may appoint the Agency as the body responsible for receiving information relating to emergency health response and preventative measures referred to in paragraph 1. 1b. Importers and downstream users placing on the market mixtures that are classified as hazardous on the basis of their health or physical effects, shall submit to the body or bodies appointed in accordance with paragraph 1 the information referred to in Part B of Annex VIII. 1c. Distributors placing on the market mixtures that are classified as hazardous on the basis of their health or physical effects shall submit to the body or bodies appointed in accordance with paragraph 1 the information referred to in Part B of Annex VIII where they subsequently distribute those mixtures in other Member States, or where they rebrand or relabel the mixtures. That obligation shall not apply if the distributors can demonstrate that the appointed body or bodies already received the same information from importers and downstream users.’ ;
• (c) in paragraph 2, point (b) is replaced by the following:
• ‘(b) where requested by the Member State, the Commission or the Agency, to undertake a statistical analysis to identify where improved risk management measures may be needed.’ ;
• (d) paragraph 3 is replaced by the following: ‘3. The appointed bodies shall have at their disposal all the information required from importers, downstream users and distributors referred to in paragraph 1c, to carry out the tasks for which they are responsible in accordance with paragraph 1.’ ;

• (25) in Article 46, the following paragraph is inserted: ‘1a. For the purpose of paragraph 1, the authorities responsible for enforcement referred to in Article 43 of this Regulation shall follow up on complaints or reports related to non-compliance with this Regulation, and verify that the corrective action referred to in Article 3, point (16), of Regulation (EU) 2019/1020 has been taken.’ ;

• (26) Article 48 is replaced by the following: ‘Article 48 Advertisement

;

• (27) the following article is added: ‘Article 48a Distance sales offers 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.’

• (28) Article 50 is amended as follows:
• (a) in paragraph 2, points (a) and (b) are replaced by the following:
• ‘(a) provide industry with up-to-date technical and scientific guidance and tools where appropriate on how to comply with the obligations laid down by this Regulation;
• (b) provide competent authorities with up-to-date technical and scientific guidance and tools on the application and implementation of this Regulation and provide support to the helpdesks established by Member States under Article 44.’ ;
• (b) the following paragraphs are added: ‘3. Where the Agency acts as an appointed body in accordance with Article 45(1a), it shall put in place the tools necessary to provide access to the information referred to in Article 45(1) to the relevant appointed body or bodies of the appointing Member State to fulfil their tasks with regard to emergency health response and preventative measures.

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• (29) in Article 52, paragraph 2 is replaced by the following: ‘2. Within 60 days of receipt of the information from the Member State, the Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 54(2) either to authorise the provisional measure for a period defined in the decision or to require the Member State to revoke the provisional measure.’ ;

• (30) Article 53 is amended as follows:
• (a) the following paragraphs are inserted: ‘1a. The Commission is empowered to adopt delegated acts in accordance with Article 53a to amend section 1.6 of Annex I in order to include the label elements that may be put on a digital label only, provided that GHS does not require such label elements to appear on the physical label. When adopting those delegated acts, the Commission shall take into account the level of digital readiness among all population groups in the Union, societal needs and the need for a high level of protection of human health and the environment. 1b. In order to adjust to technological changes and future developments in the field of digitalisation, the Commission is empowered to adopt delegated acts in accordance with Article 53a to supplement this Regulation by laying down further details on the requirements for the digital labelling referred to in Articles 34a and 34b. Those details shall cover, in particular, the IT solutions which may be used, and the alternative means for providing the information. When adopting such delegated acts, the Commission shall: (a) ensure consistency with other relevant Union acts; (b) encourage innovation; (c) ensure technological neutrality by not imposing constraints or requirements with regard to choices of technology or equipment, within the bounds of compatibility and interference avoidance; (d) take into account the level of digital readiness among all population groups in the Union, as well as the readiness of the necessary wireless and other technological infrastructure allowing unrestricted access to the information on chemicals; (e) ensure that digitalisation does not compromise the protection of human health and the environment.’ ;
• (b) paragraph 2 is replaced by the following: ‘2. The Commission, acting on behalf of the Union, and the Member States shall, in a manner appropriate to their role in the relevant UN fora, cooperate with a view to promoting the harmonisation of the criteria for classification and labelling of endocrine disruptors for human health, endocrine disruptors for the environment, persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic and very persistent and very mobile substances as well as the adaptation of criteria for alternative approaches, in particular non-animal test methods, and the assessment of the need for new criteria for immunotoxic and neurotoxic substances.’ ;
• (c) the following paragraph is added: ‘3. The Commission shall regularly evaluate the development of alternative approaches such as the alternative methods referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures, in particular non-animal test methods, and adopt delegated acts in accordance with Article 53a to update Annex I to this Regulation to reflect such technical progress, if relevant. The Commission shall adopt a delegated act in accordance with Article 53a to update Annex I to this Regulation to adapt the criteria, preferably within 18 months from the date the criteria for non-animal data being included in harmonised criteria for classification and labelling at the level of the UN.’ ;

• (31) Article 53a is amended as follows:
• (a) paragraphs 2 and 3 are replaced by the following: ‘2. The power to adopt delegated acts referred to in Article 5(8), Article 37(5) and (7), Article 45(4), and Article 53(1), (1a), (1b) and (3) shall be conferred on the Commission for a period of five years from 10 December 2024. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

; - (b) paragraph 6 is replaced by the following: ‘6. A delegated act adopted pursuant to Article 5(8), Article 37(5) and (7), Article 45(4) or Article 53(1), (1a), (1b) or (3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’ ;

• (32) Article 53c is replaced by the following: ‘Article 53c Separate delegated acts for different delegated powers 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.’

• (33) Article 54 is replaced by the following: ‘1. The Commission shall be assisted by the Committee established by Article 133 of Regulation (EC) No 1907/2006. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council ([^E0002]).

• (34) the following article is added: ‘Article 54a Reporting and review

;

• (35) in Article 61, the following paragraphs are added: ‘7. Substances and mixtures which have been classified, labelled and packaged in accordance with Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 10, Article 25(3), Articles 29 and section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I as applicable on 9 December 2024 and which were placed on the market before 1 July 2026 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 of the European Parliament and of the Council ([^E0003]) until 1 July 2028.

• (36) Annex I is amended in accordance with Annex I to this Regulation;

• (37) Annex II is amended in accordance with Annex II to this Regulation;

• (38) Annex VI is amended in accordance with Annex III to this Regulation;

• (39) Annex VIII is amended in accordance with Annex IV to this Regulation.

Article 2

3a. Article 1, points (14), (15)(c), (26) and (27), points (2) and (3) of Annex I and point (2) of Annex II shall apply from 1 January 2028

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

Part 1 of Annex I to Regulation (EC) No 1272/2008 is amended as follows:

• (1) section 1.1.1.3 is replaced by the following: ‘1.1.1.3.A weight of evidence determination means that all available information bearing on the determination of hazard is considered together, such as the results of suitable in vitro tests, relevant animal data, human experience such as occupational data and data from accident databases, epidemiological and clinical studies and well-documented case reports and observations. For substances, information from the application of the category approach (grouping, read-across) and (Q)SAR results are also considered. The quality and consistency of the data shall be given appropriate weight. Information on substances related to the substance being classified shall be considered, where appropriate. Information on substances or mixtures related to the mixture being classified shall be considered in accordance with Article 9(4). Information on the site of action and the mechanism or mode of action found in study results shall also be considered. Both positive and negative results shall be assembled together in a single weight of evidence determination.’;

• (2) section 1.2.1.4 is replaced by the following: ‘1.2.1.4.The dimensions of the label and of each pictogram, and the font size of letters shall be as follows: Table 1.3 Minimum dimensions of labels and pictograms and minimum font size Capacity of the package Dimensions of the label (in millimetres) for the information required by Article 17 Dimensions of each pictogram (in millimetres) Minimum font size (x-height in millimetres) Not exceeding 0,5 litres If possible, at least 52×74 Not smaller than 10×10 If possible, at least 16×16 1,2 Greater than 0,5 litres but not exceeding 3 litres 1,4 Greater than 3 litres but not exceeding 50 litres At least 74×105 At least 23×23 1,8 Greater than 50 litres but not exceeding 500 litres At least 105×148 At least 32×32 2,0 Greater than 500 litres At least 148×210 At least 46×46 2,0 ’

• (3) the following section is added: ‘1.2.1.5.The text on the label shall have the following characteristics:
• (a) printed in black on a white background;
• (b) the distance between two lines shall be at least 120 % of the font size;
• (c) a single font that is easily legible and without serifs shall be used;
• (d) the letter spacing shall be appropriate for the selected font to be easily legible. For the labelling of inner packaging where the contents do not exceed 10 ml, the font size may be smaller than indicated in Table 1.3, as long as it remains easily legible, where it is deemed important to place the most critical statement, such as a hazard statement or EUH statement, and where the outer packaging meets the requirements of Article 17.’

• (4) the following section is added: ‘1.2.1.6.   Fold-out labels 1.2.1.6.1.The front page of the fold-out label shall include at least the following elements:
• (i) the name, address and phone number of suppliers;
• (ii) nominal quantity of the substance or mixture in the package made available to the general public, unless this quantity is specified elsewhere on the package;
• (iii) the product identifiers in accordance with Article 18(2) for substances and Article 18(3)(a) for mixtures in all languages of the label that are used in the inside pages;
• (iv) where applicable, the hazard pictograms;
• (v) where applicable, the signal words in all languages of the label that are used in the inside pages;
• (vi) where applicable, the unique formula identifier, unless printed or affixed on the inner packaging in accordance with Part A, point 5.3, of Annex VIII to this Regulation;
• (vii) a reference to the full safety information inside the fold-out label in all languages of the label or a symbol to inform a user that the label can be opened and to illustrate that additional information is available on inside pages;
• (viii) an abbreviation of the language (country code or language code) for all the languages that are used in the inside pages. 1.2.1.6.2.The inner pages of the fold-out label shall contain all the label elements provided for in Article 17(1), except for the hazard pictogram and the supplier identification, in each of the languages mentioned on the front page and grouped by language, using the language abbreviation (country code or language code). 1.2.1.6.3.The back page of the fold-out label shall contain all the label elements provided on the front page, except for the abbreviations of the languages that are used in the inside pages.’;

• (5) the following section is added: ‘1.3.7.   Ammunition In the case of ammunition that is a substance or mixture and that is shot through a firearm, the label elements may be provided on the intermediate packaging instead of on the inner packaging, or, if there is no intermediate packaging, on the outer packaging.’;

• (6) the heading of section 1.5.1 is replaced by the following: ‘1.5.1.   Exemptions from Article 31 in accordance with Article 29(1)’;

• (7) section 1.5.1.1 is replaced by the following: ‘1.5.1.1.Where Article 29(1) applies, the label elements referred to in Article 17 may be provided on a tie-on tag or on an outer packaging.’;

• (8) section 1.5.1.2 is replaced by the following: ‘1.5.1.2.Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the signal words, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, and the name and telephone number of the suppliers of the substance or mixture.’;

• (9) the heading of section 1.5.2 is replaced by the following: ‘1.5.2.   Exemptions from Article 17 in accordance with Article 29(2)’;

• (10) section 1.5.2.4.1 is replaced by the following: ‘1.5.2.4.1.The label elements required by Article 17 may be omitted from the inner packaging where the contents of the inner packaging do not exceed 10 ml and any of the following applies:
• (a) the substance or mixture is placed on the market for supply to a distributor or downstream user for scientific research and development or quality control analysis and the inner packaging is contained within outer packaging that meets the requirements set out in Article 17;
• (b) the substance or mixture does not require labelling in accordance with Part 1 or 2 of Annex II and is not classified in any of the following hazard classes and categories:
• (i) acute toxicity, any category;
• (ii) specific target organ toxicity – single exposure, categories 1 and 2;
• (iii) specific target organ toxicity – repeated exposure, any category;
• (iv) skin corrosion, category 1, any sub-category;
• (v) serious eye damage, category 1;
• (vi) respiratory sensitisation, any category;
• (vii) aspiration hazard;
• (viii) germ cell mutagenicity, any category;
• (ix) carcinogenity, any category;
• (x) reproductive toxicity, any category;
• (xi) endocrine disruption for human health, any category;
• (c) the substance or mixture requires labelling in accordance with Part 1 or 2 of Annex II but is not classified in any of the hazard classes and categories referred to in point (b) of this section and has an inner packaging that is contained within outer packaging that meets the requirements set out in Article 17.’;

• (11) the following section is added: ‘1.6.   Label elements that may be provided on a digital label only Supplemental information referred to in Article 25(3).’.

ANNEX II

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

• (1) in Part 3, the following section is added: ‘3.4.   Supply via refill stations When hazardous substances or mixtures are supplied in accordance with Article 35(2a), the supplier shall ensure that the following conditions are met:
• (a) the refill station carries labels corresponding to the labels for each hazardous substance or mixture supplied at the station;
• (b) the labels on the refill station are firmly affixed horizontally on a visible place and fulfil the requirements in Article 31(2), (3) and (4) mutatis mutandis;
• (c) risk mitigation measures are applied to minimise the exposure of humans, especially of children, and of the environment;
• (d) measures are taken to prevent uncontrolled use of the refill station by children;
• (e) at the moment of refill, the supplier is available on site for maintenance and immediate assistance, including emergency assistance;
• (f) refill stations can be operated outdoors and outside business hours only if immediate assistance can be provided;
• (g) the substances or mixtures provided through a refill station do not react with each other in a way that could endanger clients or staff;
• (h) staff of the supplier are appropriately trained to minimise safety risks to consumers, professional users and themselves;
• (i) for every refilled package, the requirements on hazard communication in the form of labelling set out in Title III of this Regulation are fulfilled;
• (j) for every refilled package the requirements on packaging set out in Title IV of this Regulation are fulfilled;
• (k) hazardous substances or mixtures are not provided at a refill station if the criteria for classification in any of the following hazard classes or differentiations are met:
• (i) acute toxicity, any category;
• (ii) specific target organ toxicity – Single exposure, any category;
• (iii) specific target organ toxicity – repeated exposure, any category;
• (iv) skin corrosion, category 1, any sub-category;
• (v) serious eye damage category 1;
• (vi) respiratory sensitisation, any category;
• (vii) skin sensitisation, any category;
• (viii) aspiration hazard;
• (ix) germ cell mutagenicity, any category;
• (x) carcinogenicity, any category;
• (xi) reproductive toxicity, any category;
• (xii) flammable gases, any category;
• (xiii) flammable liquids, categories 1 and 2;
• (xiv) flammable solids, any category;
• (xv) endocrine disruption for human health, any category.;
• (xvi) endocrine disruption for the environment, any category;
• (xvii) persistent, bioaccumulative and toxic;
• (xviii) very persistent and very bioaccumulative;
• (xix) persistent, mobile and toxic;
• (xx) very persistent and very mobile. By way of derogation from point (a), a single label on the refill station may be used for several substances or mixtures for which the label elements referred to in Article 17(1) are identical, provided that the label clearly indicates the name of each substance or mixture that it applies to.’;

• (2) Part 5 is replaced by the following: ‘PART 5: HAZARDOUS SUBSTANCES AND MIXTURES TO WHICH ARTICLE 29(3) APPLIES Ready mixed cement and concrete in the wet state shall be accompanied by a copy of the label elements in accordance with Article 17. For a substance or a mixture supplied at a filling station and directly pumped into a receptacle that forms an integral part of a vehicle and from where the substance or mixture is normally not intended to be removed, the label elements referred to in Article 17 shall be provided on a visible place on the respective pump. When vehicle fuels are supplied at a filling station through pumping into portable receptacles designed to be used for fuels, a physical copy of the label elements referred to in Article 17 shall, in addition to the visible place on the pump, also be provided to be attached to the receptacle.’.

ANNEX III

In Annex VI, Part 2 is replaced by the following:

‘2.   PART 2: DOSSIERS FOR HARMONISED CLASSIFICATION AND LABELLING

This Part lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling.

The relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 shall be used for the methodology and format of any dossier.

For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used. For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier.

A dossier for harmonised classification and labelling shall contain the following:

— Proposal The proposal shall include the identity of the substance or substances concerned and the harmonised classification and labelling proposed;

— Justification for the proposed harmonised classification and labelling A comparison of the available information with the criteria contained in Parts 2 to 5, taking into account the general principles in Part 1 of Annex I to this Regulation shall be completed and documented in the format set out in Part B of the Chemical Safety Report in Annex I to Regulation (EC) No 1907/2006.

— Justification for the proposed grouping of substances for the purpose of harmonised classification and labelling Where a harmonised classification and labelling proposal is made for a group of substances, the dossier shall include a scientific justification.

— Justification for other effects at Community level For effects other than carcinogenity, mutagenicity, reprotoxicity, endocrine disruption for human health and the environment, persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic, very persistent and very mobile, and respiratory sensitisation, a justification that there is a need for action demonstrated at Union level shall be provided. This shall not apply for an active substance within the meaning of Regulation (EU) No 1107/2009 or Regulation (EU) No 528/2012.’.

ANNEX IV

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