Changes from adopted text to adopted text

RemovedRecital 13: (13) In order to adapt the label elements allowed to be provided only in a digital format to technical progress or to the level of digital readiness among all population groups in the Union, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union to amend the list of label elements allowed to be provided only in a digital format, taking into account societal needs, ensuring high level of protection of human health and the environment and sufficient information on chemicals that citizens are exposed to.

RemovedRecital 18: (18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and could cover a group of similar substances, where such similarity based on scientific justification, allows for similar classification of all substances in the group. The grouping process should be scientifically robust, coherent and transparent for all stakeholders. The purpose of such grouping is to alleviate the burden on manufacturers, importers or downstream users, the Agency and the Commission in the procedure for harmonisation of classification and labelling of substances. It also avoids testing of substances when similar substances can be classified as a group. Where it is scientifically justified and possible, proposals for classification should prioritise groups of substances rather than individual substances. In the event of a proposal for harmonised classification and labelling of a group of substances, those substances should be grouped together based on clear scientific criteria, including structural similarity and similar evidence-based hazard profiles.

RemovedRecital 19: (19) To increase transparency and predictability of the proposals submitted to the Agency, the Member States’ competent authorities, manufacturers, importers or downstream users should be required to notify the Agency of their intention to submit a proposal for harmonised classification and labelling, while the Commission should be required to notify the Agency of its request to the Agency or to the Authority to prepare such proposal. Furthermore, the Agency should be required to publish information on such intention or request and update the information regarding the submitted proposal at each stage of the procedure for the harmonised classification and labelling of substances. Interested parties should be given the opportunity to comment where appropriate. For the same reason, a competent authority that receives a proposal for revision of a harmonised classification and labelling submitted by a manufacturer, importer or downstream user should be required to communicate its decision to accept or refuse the proposal for revision to the Agency, which should share that information with the other competent authorities. To increase the efficiency of the harmonized classification and labelling process, the Commission should adopt a delegated act, no later than 12 months following the publication of the RAC opinion.

RemovedRecital 24: (24) Manufacturers and importers often notify different information for the same substance to be included in the Agency’s inventory for classification and labelling. In some cases, such divergences result from different impurities, physical states or other differentiations and may be justified. In other cases, the divergences are due to differences in data used for classification, or to disagreement between notifiers or registrants in the case of joint submission of data in accordance with Regulation (EC) No 1907/2006, or to obsolete classification entries. As a result, the classification and labelling inventory contains divergent classifications, which makes the inventory less effective as a hazard collection and communication tool and leads to incorrect classifications, ultimately hindering the ability of Regulation (EC) No 1272/2008 to protect human health and the environment. Therefore, the notifiers should be required, without needing to acquire new data or new studies being necessary, to provide reasons for divergence from the most severe classification or for introducing a more severe classification per hazard class for the same substance to the Agency. To address divergences between more recent and obsolete classifications, notifiers should be required to update their notifications within 6 months after a decision to change the classification and labelling of a substance has been taken pursuant to a review in Article 15(1) of that Regulation. Moreover, the Agency shou…

RemovedRecital 25: (25) In order to enhance transparency of notifications as well as to facilitate the notifiers’ duty to come to an agreed notification entry for the same substance, all information notified to the Agency’s classification and labelling inventory should be made publicly available, free of charge. Without prejudice to the protection of commercial interests, that information should include the identity of the notifiers as, knowing whom to contact, would facilitate the objective of coming to an agreed entry to be included in that classification and labelling inventory. In the case of notifications by a group of manufacturers or importers, it should suffice to make publicly available the identity of the notifier submitting the information on behalf of the other members of the group.

AddedP9_TC1-COD(2022)0432

RemovedRecital 29: (29) Regulation (EC) No 1272/2008 regulates advertisement of hazardous substances and mixtures in a general manner and provides that an advertisement for a substance classified as hazardous is to mention the hazard classes or hazard categories concerned, and an advertisement for a mixture classified as hazardous or a mixture containing a classified substance is to mention the types of hazards indicated on the label where such advertisement allows concluding a contract for purchase without first having sight of the label. This obligation should be changed to ensure that the advertisement of hazardous substances and mixtures contains all the information which is most important in terms of safety and protection of health and the environment. Therefore, the advertisement should contain the hazard pictogram, the signal word, the hazard class and the hazard statements. The hazard category should not be provided, as it is reflected by the hazard statement.

AddedPosition of the European Parliament adopted at first reading on 23 April 2024 with a view to the adoption of Regulation (EU) 2024/… of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures

RemovedRecital 33: (33) In accordance with Directive 2010/63/EU of the European Parliament and of the Council47, it is necessary to replace, reduce or refine testing on animals, with a view to phasing out the use of animals for testing as soon as possible. Implementation of Regulation (EC) No 1272/2008 should be based on the promotion and use of New Approach Methodologies (NAM), suitable for the assessment of health and environmental classification of chemicals, wherever possible. In order to speed up the transition to non-animal methods, with the ultimate goal of fully replacing animal testing, as well as to improve the efficiency of chemical hazard assessments, innovation in the field of non-animal methods should be promoted, monitored and systematically and periodically evaluated, and the Commission and the Member States acting in the interest of the Union should promote the inclusion of harmonised criteria based on available alternative methods, including new approach methods, in UN GHS and subsequently include those criteria in Regulation (EC) No 1272/2008 without delay.

Added(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2024/2865.)

RemovedRecital 35 a (new): (35a) Where appropriate, the Agency should provide further guidance on the application of the provisions relating to the review of this Regulation.

RemovedRecital 36 a (new): (36a) The amendments introduced by this regulation expand the tasks, workload and remit of the Agency. In order to provide adequate expertise, support, and thorough scientific evaluations, appropriate and stable funding for the Agency should be ensured under the framework of the upcoming Regulation establishing the ECHA.

RemovedRecital 37: (37) To ensure that suppliers of substances and mixtures have time to adapt to new rules on classification, labelling and packaging, the application of some provisions of this Regulation should be deferred. Substances and mixtures which are already placed on the market before the end of that deferral period, should be allowed to continue being placed on the market without being re-classified and re-labelled in accordance with this Regulation, to avoid additional burden on suppliers of substances and mixtures.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point -1 (new), Article 1 – paragraph 1: -1 In Article 1, paragraph 1 is replaced by the following: / "The purpose of this Regulation is to ensure a high level of protection of human health and the environment including the promotion of alternative methods, for assessment of hazards of substances and mixtures, as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by: (a) harmonising the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures; (b) providing an obligation for: (i) manufacturers, importers and downstream users to classify substances and mixtures placed on the market; (ii) suppliers to label and package substances and mixtures placed on the market; (iii) manufacturers, producers of articles and importers to classify those substances not placed on the market that are subject to registration or notification under Regulation (EC) No 1907/2006;"

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 2, Article 2 – paragraph 1 – point 7a: deleted

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 2, Article 2 – paragraph 1 – point 38 a (new): 38a. ‘refill’ means an operation through which a consumer or a professional user fills its own container, which fulfils the packaging function, with a hazardous substance or mixture offered by a supplier in the context of a commercial transaction;

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 2, Article 2 – paragraph 1 – point 38 b (new): 38b. ‘refill station’ means a place where a supplier offers to consumers or professional users hazardous substances or mixtures that can be purchased through refill;

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 2 a (new), Article 3 – paragraph 1: (2a) In Article 3, paragraph 1 is replaced by the following: / "A substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I is hazardous and shall be classified in relation to the respective hazard classes provided for in that Annex. Gender differences with regard to the susceptibility to chemicals shall be taken into consideration, where relevant."

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 1: 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 examined and evaluated in accordance with the criteria set out in this paragraph, using the available information on those known constituents above the applicable concentration limit as well as on the substance itself.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 2: For the evaluation of these substances 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 or downstream user shall use the relevant available information referred to in paragraph 1 for each of the known individual constituents, impurities and additives in the substance,

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 3 – introductory part: Relevant available information on the substance containing more than one constituent itself shall be taken into account where one of the following conditions are met:

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 3 – point a: (a) the information demonstrates germ cell mutagenic, carcinogenic, or toxic to reproduction properties, or endocrine disruption for human health or the environment;

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 4: Relevant available information on the substance containing more than one constituent itself showing absence of certain properties or less severe properties shall not override the relevant available information on the constituents in the substance.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 5: For the evaluation of substances 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’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ 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 or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual known constituents, impurities or additives in the substance.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 6 – introductory part: Relevant available information on the substance containing more than one constituent itself shall be taken into account where one of the following conditions are met:

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 6 – point a: (a) the information demonstrates persistence, mobility and bioaccumulation properties or lack of biodegradation;

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 7: Relevant available information on the substance containing more than one constituent itself showing absence of the properties referred to in (a) or less severe properties shall not override the relevant available information on the constituents in the substance.

RemovedRegulation EC 1272/2008

RemovedArticle 1 – paragraph 1 – point 4 a (new), Article 5 – paragraph 3a (new): (4a) in Article 5, the following paragraph is added: / "3a. Paragraph 3 shall not apply to substances containing more than one constituent of renewable botanical origin that are not chemically or genetically modified without prejudice to the application of Regulation (EU) No 1107/2009 1a or Regulation (EU) No 528/2012. 1b / 1a Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). / 1b Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 5, Article 6 – paragraph 3 – subparagraph 1: For the evaluation of mixtures pursuant to chapter 2 of this Title in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘endocrine disrupting property for human health’ and ‘endocrine disrupting property 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 or 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.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 5, Article 6 – paragraph 3 – subparagraph 2: However, for the one plant protection product or the one biocidal product for which the approval criteria of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 need to be met, respectively, for the approval of the corresponding active substance, or where the available test data on the mixture itself demonstrates germ cell mutagenic, carcinogenic or toxic to reproduction properties, or endocrine disrupting properties 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, data on the mixture as a whole shall also be taken into account for the purposes of the evaluation of the mixture referred to in the first subparagraph.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 5, Article 6 – paragraph 4: 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’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ 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 or 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 ; / However, where the available test data on the mixture itself demonstrate a lack of biodegradation, persistency, mobility and bioaccumulation properties that have not been identified from the relevant available information on the individual substance referred to in the first subparagraph, such data shall also be taken into account for the purpose of evaluating the mixture referred to in the first subparagraph.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 5 a (new), Article 7: (5 a) Article 7 is replaced by the following: / "Article 7 / Non-animal, animal, and human testing / 4. Tests using new approach methodologies shall also be considered."

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 6, Article 9 – paragraph 3: 3. Where the criteria referred to in paragraph 1 cannot be applied directly to available identified information, or where properties are defined by multiple criteria, 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.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 7 a (new), Article 17: (7a) Article 17 is replaced by the following : / "Article 17 / (ha) where applicable, a link to the digital label where further information can be found. / Suppliers may use more languages on their labels than those required by the Member States, provided that the same details appear in all languages used. / The information in points (h) and (ha) in paragraph 1 may be provided on the inner pages of a fold-out label."

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 7 b (new), Article 18 – paragraph 3 – subparagraph 1– point b: (7b) In Article 18, paragraph 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, endocrine disruption for human health, endocrine disruption for the environment, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard, persistent, bioaccumulative and toxic (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent, very mobile (vPvM) properties."

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 8 a (new), Article 25 – paragraphs 2 and 3: (8a) In Article 25, paragraphs 2 and 3 are replaced by the following: / "2. A statement shall be included in the section for supplemental information on the label where a substance or mixture classified as hazardous falls within the scope of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012. The statement shall be worded in accordance with Part 4 of Annex II and Part 3 of Annex III to this Regulation. / 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 7, provided that that information does not make it more difficult to identify the label elements referred to in Article 17(1) (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."

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 9, Article 25 – paragraph 6 – subparagraph 1: The specific labelling rules set out in Part 2 of Annex II shall apply to mixtures containing substances referred to in that Annex. The statements shall be worded in accordance with Part 3 of Annex III and shall be placed in the supplemental information section of the label. The label shall also include the product identifier referred to in Article 18 and the name, address and telephone number of the supplier of the mixture.

RemovedArticle 1 – paragraph 1 – point 13 – introductory part: (13) in Article 31, paragraph 1, the following sentence is added:

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 13, Article 31 – paragraph 1: "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 also be presented in a form of a fold out label."

RemovedRegulation (EC) 1272/2008

RemovedArticle 1 – paragraph 1 – point 13, Article 31 – paragraph 3: 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 size and spacing as to be easily read.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 13 a (new), Article 32 – paragraph 6: (13a) In Article 32, paragraph 6 is replaced by the following: / "6. Where the label elements referred to in Article 17(1) are provided by means of a fold-out label, the front page shall contain at least the information provided in accordance with Article 17(1)(e), (f) and (g) in all official languages of the Member State where the product is put on the market along with a reference to the additional information provided on the inside page or pages."

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 15, Article 34b – paragraph 1 – point d: (d) the digital label shall be accessible free of charge, without the need to register, download or install specific applications, or to provide a password;

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 16, Article 35 – paragraph 2a: 2a. Hazardous substances or mixtures may be supplied to consumers and professional users via refill stations only if, in addition to the requirements set out in Titles III and IV, the conditions laid down in section 3.4 of Annex II are fulfilled. / This paragraph shall not apply to hazardous substances or mixtures supplied to the general public without packaging in accordance with Article 29(3).

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 18 – point a, Article 37 – paragraph 1 – subparagraph 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 revision thereof.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 18 – point a, Article 37 – paragraph 1 – subparagraph 2: The Commission may ask the Agency or the European Food Safety 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 Agency and the Authority may, on their own initiative, provide scientific advice to the Commission and Member States on substances or a group of substances where a harmonised classification could be necessary to protect human and animal health and the environment.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 18 – point a, Article 37 – paragraph 1 – subparagraph 3: 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.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 18 – point a, Article 37 – paragraph 1 – subparagraph 3 a (new): 'Whenever considered scientifically justified and possible by a competent authority or the Commission, proposals for harmonised classification and labelling shall prioritise groups of substances rather than individual substances.'

RemovedRegulation (EC) 1272/2008

RemovedArticle 1 – paragraph 1 – point 18 – point b, Article 37 – paragraph 2 – subparagraph 1: 2. Manufacturers, importers or downstream users of substances may submit to the Agency a proposal for harmonised classification and labelling of those 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. In the case of a proposal for harmonised classification and labelling of a group of substances, those substances shall be grouped together based on clear scientific criteria (as specified in REACH Annex XI (1.5)), including structural similarity and similar evidence-based hazard profiles.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 18 – point c, Article 37 – paragraph 2a – subparagraph 2: Within one week from receipt of the notification, the Agency shall publish the name, the EC and CAS numbers of the substance(s), and where relevant, 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 Article 37(4) and (5).

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 18 – point e, Article 37 – paragraph 5 – subparagraph 1: The Commission, within twelve months of the publication of the opinion of the Committee for Risk Assessment, shall adopt delegated acts in accordance with Article 53a to amend Annex VI by inclusion of substances or mixtures together with the relevant classification and labelling elements and, where appropriate, the specific concentration limits, M-factors or acute toxicity estimates in Table 3 of Part 3 of Annex VI.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 18 – point e, Article 37 – paragraph 6: 6. Manufacturers, importers and downstream users who have new information which may lead to change of the harmonised classification and labelling elements of substances in Part 3 of annex VI shall submit a proposal in accordance with paragraph 2, second subparagraph, to the competent authority in one of the Member States in which the substances are placed on the market.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 18 – point f, Article 37 – paragraph 7 – subparagraph 1: By 1 January 2026, the Commission shall adopt delegated acts in accordance with Article 53a to amend Table 3 of Part 3 of Annex VI to this Regulation by inclusion of substances as endocrine disruptor category 1 for human health properties, endocrine disruptor category 1 for environment properties, as persistent, bioaccumulative and toxic, as very persistent and very bioaccumulative, as persistent, mobile and toxic, or very persistent and very mobile together with relevant classification and labelling elements where, on 1 January 2025, those substances have been included in the candidate list referred to in Article 59(1) of Regulation (EC) No 1907/2006.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 20 – point a – point ii, Article 40 – paragraph 1 – subparagraph 1 – point g: (g) where applicable, and without needing to acquire new data or new studies being necessary, the reason for divergence from the most severe classification per hazard class included in the inventory referred to in Article 42;

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 20 – point a – point ii, Article 40 – paragraph 1 – subparagraph 1 – point h: (h) where applicable and without needing to acquire new data or new studies being necessary, the reason for introducing a more severe classification per hazard class compared to those included in the inventory referred to in Article 42;

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 20 a (new), Article 41: (20a) Article 41 is replaced by the following: / "Article 41 / Where the notification in Article 40(1) results in different entries on the inventory referred to in Article 42 for the same substance, the notifiers and registrants shall make every effort to come to an agreed entry to be included in the inventory. The notifiers shall inform the Agency accordingly. In case where notifiers and registrants cannot come to an agreed entry because of divergences about the level of scientific evidence supporting a classification and labelling of the same substance, the most protective classification shall prevail.'"

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 21, Article 42 – paragraph 1 – subparagraph 3 – introductory part: The following information shall be made publicly available free of charge online in a user-friendly format:

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 21, Article 42 – paragraph 1 – subparagraph 3 – point a: (a) information referred to in Article 40(1), point (a);

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 21 a (new), Article 42 – paragraph 3 a (new): (21a) In the Article 42, the following paragraph 3a is added: / "3a. Where the Agency considers that an entry is incomplete, incorrect or obsolete it shall delete the corresponding entry from the inventory after having informed the notifier."

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 21 b (new), Article – 43 (new): (21b) The following Article -43 is inserted: / Article -43 / Right to request action from competent authorities and the Commission / 1. Any natural or legal person, individually or in association, shall be entitled to submit substantiated evidence to competent authorities as referred to in Article 43 or the Commission, such as peer-reviewed studies, human biomonitoring data, or environmental monitoring data, on the hazardous properties of a substance or mixture, or of substances or mixtures, showing that hazardous properties of a substance or mixture or of substances or mixtures may not have been sufficiently considered in the classification or labelling process. / 2. The competent authorities or the Commission shall diligently and impartially assess the information submitted in accordance with paragraph 1, adding the evidence submitted to all other available evidence using a weight of evidence approach. / 3. Where the evidence submitted shows non-compliance with one or several of the requirements on the classification, labelling and packaging of substances and mixtures, enforcement measures shall be initiated in accordance with Article 47. / 4. Where the assessment has shown that the substance meets the criteria for classification in any of the hazard classes referred to in Article 36(1), the competent authority or the Commission shall initiate a process of harmonised classification and labelling. Where the assessment has shown a wide dispersive use of and/or consumer exposu…

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 21 c (new), Article – 43 a (new): (21c) The following Article -43a is added: / Article -43a / Access to justice / 1. Any natural or legal person which has submitted a substantiated concern in accordance with Article -43a shall have access to an administrative or judicial procedure to review the procedural and substantive legality of the decisions, acts or omissions of the relevant competent authority under this Regulation. / 2. Member States shall ensure access to administrative or judicial procedures to review their decisions, acts and omissions, in accordance with national law or practice. Decisions, acts and omissions by the Commission shall be subject to review in accordance with Regulation EU (No) 1367/2006. / 3. The procedures referred to in paragraph 2 shall be fair, equitable, timely and not prohibitively expensive while providing adequate and effective remedies, including injunctive relief where necessary. Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 23, Article 48 – paragraph 1: 1. Any advertisement for a substance classified as hazardous shall indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements. Any advertisement for a substance for sale to the general public shall in addition indicate “always read and follow the information on the product label.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 23, Article 48 – paragraph 2: 2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) shall indicate the hazard pictogram, the signal word, the hazard class and the hazard statements. Any advertisement for sale of mixtures to the general public shall, in addition, indicate “always read and follow the information on the product label.

RemovedRegulation (EC) 1272/2008

RemovedArticle 1 – paragraph 1 – point 23, Article 48 – paragraph 2a (new): 2a. The use of environmental claims as defined in Article 2, point (o), of Directive 2005/29/EC shall be prohibited for substances and mixtures which are classified as hazardous due to their germ cell mutagenic, carcinogenic, toxic to reproduction, endocrine disruption for human health or the environment, persistent, bioaccumulative and toxic (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), or very persistent, very mobile (vPvM) properties;

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 25 – point -a (new), Article 50 – paragraph 2 – point a: (-a) in Article 50, paragraph 2, point a is amended as 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;"

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 25 – point a, Article 50 – paragraph 2 – point b: (b) provide competent authorities with up to date technical and scientific guidance and tools on the operation and implementation of this Regulation and provide support to the helpdesks established by Member States under Article 44.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 25 – point b a (new), Article 50 – paragraph 3 a (new) and 3 b (new): (ba) the following paragraphs are added: / “3a. The Agency shall be provided with adequate resources to support its work. / 3b. In order to provide adequate expertise, support, and thorough scientific evaluations, appropriate and stable funding for the Agency shall be ensured.”

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 26 – point -a (new), Article 53 – paragraph 1: (-a) In Article 53, paragraph 1 is replaced by the following: / "1. The Commission may adjust and adapt Articles 6(5), 11(3), 12, 14, 18(3)(b), 23, 25 to 29 and 35(2) second and third subparagraph and Annexes I to VII to technical and scientific progress, including the promotion of alternative methods for assessment of hazards of substances and mixtures, taking due account of the further development of the GHS, in particular any UN amendments relating to the use of information on similar mixtures, and considering the developments in internationally recognised chemical programmes and of the data from accident databases. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 54(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 54(4)."

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 26 – point a, Article 53 – paragraph 1a: 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 adapt the label elements referred to in Article 34a(2) to technical progress or to the level of digital readiness among all population groups in the Union. When adopting those delegated acts, the Commission shall ensure a high level of protection of human health and the environment and take into account societal needs. The Commission shall make sure that information which is critical to protect human health and the environment shall be easily accessible on the label;

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 26 – point a, Article 53 – paragraph 1b – point d: (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;

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 26 – point b, Article 53 – paragraph 2: 2. The Commission or the Member States acting in the interest of the Union shall, in the manner appropriate to their role in the relevant UN fora, promote the harmonisation of the criteria for classification and labelling of endocrine disruptors for human health, endocrine disruptors for the environment, persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT) and very persistent and very mobile (vPvM) substances as well the development of criteria for immunotoxic and neurotoxic substances as well as alternative test methods, including new approach methods and in particular non-animal methods at the level of the UN to address existing and emerging hazard classes.;

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 26 – point c, Article 53 – paragraph 3: 3. The Commission shall promote and evaluate the development of alternative test methods referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures, including new approach methods and in particular non-animal test methods, at least every three years, 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 no more than twelve months after non-animal data are included in harmonised criteria for classification and labelling at the level of the UN.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 26 – point c a (new), Article 53 – paragraph 3 a (new): (ca) In Article 53, paragraph 3a is added as following: / "3a. The Commission shall assess the introduction of hazard criteria for immunotoxicity and neurotoxicity by 31 December 2025 and, where appropriate, adopt delegated acts in accordance with Article 53a. The Commission shall foster the rapid introduction of those hazard classes at the UNGHS."

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 27 – point a, Article 53a – paragraph 2: The power to adopt delegated acts referred to in Articles 37(5), 37(7), 37(8), 45(4), 53(1), 53(1a), 53(1b), 53(3) and 53(3a) shall be conferred on the Commission for a period of five years from [OP please insert the date = the date of entry into force of this Regulation].

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 27 – point b, Article 53a – paragraph 3: The delegations of power referred to in Articles 37(5), 37(7) and 37(8), 45(4), 53(1), 53(1a), 53(1b), 53(3) and 53(3a) may be revoked at any time by the European Parliament or by the Council.

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 27 – point c, Article 53 – paragraph 6: A delegated act adopted pursuant to Article Articles 37(5), 37(7), 37(8), 45(4), 53(1), 53(1a), 53(1b), 53(3) or 53(3a) 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.;

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 29 a (new), Article 54 a (new): (29a) the following article is inserted: / "Article 54a / Review Clause / No sooner than [insert date six years after the date of entry into force of this Regulation], the Commission shall present a report to the European Parliament and the Council regarding the evaluation and classification of substances of renewable botanical origin containing more than one constituent referred to in Article 5(3a).";

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 30, Article 61 – paragraph 7: Substances which have been classified, labelled and packaged in accordance with Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first sub-paragraph 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 as applicable on … [OP: please insert the date = the day before the entry into force of this Regulation] and which were placed on the market before [OP: please insert the date = the first day of the month following 18 months after the date of entry into force of this Regulation ] are not required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation …/… of the European Parliament and of the Council* [OP: please complete the reference in the footnote – it should be the reference to this Regulation] until … [OP: please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation].

RemovedRegulation (EC) No 1272/2008

RemovedArticle 1 – paragraph 1 – point 30 – point a (new), Article 61 – paragraph 7 a (new): a) In Article 61, the following paragraph is added: / "7a. Mixtures which have been classified, labelled and packaged in accordance with Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third subparagraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, 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 as applicable on … [OP: please insert the date = the day before the entry into force of this Regulation] and which were placed on the market before [OP: please insert the date = the first day of the month following 24 months ] after the date of entry into force of this Regulation ] are not required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation …/… of the European Parliament and of the Council* [OP: please complete the reference in the footnote – it should be the reference to this Regulation] until … [OP: please insert the date =the first day of the month following 48 months after th…

RemovedArticle 2 – paragraph 2 – introductory part: 2. The following provisions shall apply to substances and mixtures from [OP: please insert the date = the first day of the month following 18 months after the date of entry into force of this Regulation]:

RemovedArticle 2 – paragraph 2 a (new): 2a. The following provisions shall apply to mixtures from [OP: please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation]: (a) Article 1, points (1), (4), (5), (6), (7), (10), (11), (12), (15), (16), (20), (21), (23) and (24); (b) points (2), (3), (7), (9) and (10) of Annex I; (c) Annex II; (d) points (1)(c), (2), (3) and (4) of Annex III.

RemovedArticle 2 – paragraph 3 – introductory part: 3. By way of derogation from Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first sub-paragraph 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 [OP: please insert the date = the day before the date of entry into force of this Regulation], substances may until … [OP: please insert the date = 18months after the date of entry into force of this Regulation] and mixtures may until … [OP: please insert the date = the last day of the month following 35 months after the date of entry into force of this Regulation] be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by the following provisions of this Regulation:

RemovedRegulation (EC) No 1272/2008

RemovedRegulation (EC) No 1272/2008

RemovedRegulation (EC) No 1272/2008

RemovedRegulation (EC) No 1272/2008

RemovedRegulation (EC) No 1272/2008

RemovedAnnex I – paragraph 1 – point 3 a (new), Annex I – Part 1 – Section 1.2.1.5 a (new)): (3a) In Annex I, part I, the following section is added: / Section 1.2.1.5.a For multilingual labels, the languages shall be ordered in a logical way, e.g. alphabetically.

RemovedRegulation (EC) No 1272/2008

RemovedAnnex I – paragraph 1 – point 9, Annex I – Part 1 – Section 1.5.2.4.1. – point b – point iv a (new): (iva) Serious eye damage category 1/eye irritation, category 2;

RemovedRegulation (EC) No 1272/2008

RemovedAnnex I – paragraph 1 – point -1 (new), Annex I – Part 1 – Section 1.5.2.4.1. – point b – point v a (new): (va) Skin sensitisation, category 1 (sub-categories 1A and 1B);

RemovedRegulation (EC) No 1272/2008

RemovedAnnex II – paragraph 1 – point -1 a(new), Annex II – Part 3 – Section 3.1.1.1: -1a in Part 3 of Annex II to Regulation (EC) No 1272/2008, point 3.1.1.1. is amended as following: / "3.1.1.1. Packaging of whatever capacity containing a substance or mixture supplied to the general public and classified for acute toxicity, categories 1 to 3, STOT — single exposure category 1, STOT — repeated exposure category 1, or skin corrosion category 1, or serious eye damage category 1 shall be fitted with child-resistant fastenings."

RemovedRegulation (EC) No 1272/2008

RemovedAnnex II – paragraph -1 a (new), Annex II – Part 3 – section 3.2.1: (-1a) In Part 3 of Annex II, section 3.2.1. is replaced by the following: / "3.2.1. Packaging to be fitted with a tactile warning / Where substances or mixtures are supplied to the general public and classified for acute toxicity, skin corrosion/skin irritation, serious eye damage/eye irritation, endocrine disruption for human health category 2, endocrine disruption for the environment category 2, germ cell mutagenicity category 2, carcinogenicity category 2, reproductive toxicity category 2, respiratory or skin sensitization, STOT categories 1 or 2, aspiration hazard, flammable gases, flammable liquids categories 1 or 2, or flammable solids, the packaging of whatever capacity, shall be fitted with a tactile warning of danger. "

RemovedRegulation (EC) No 1272/2008

RemovedAnnex II – paragraph 1 – point 1, Annex II – Part 3 – Section 3.4 – point b: (b) a label is firmly affixed on a visible place of the refill station and fulfils the requirements of Article 31;

RemovedRegulation (EC) No 1272/2008

RemovedAnnex II – paragraph 1 – point 1, Annex II – Part 3 – Section 3.4 – point b a (new): (ba) a label is available at the refill station, free-of-charge for consumers in a self-adhesive sticker form to be affixed on the container used by the consumer. Where refill stations provide several substances or mixtures, labels should easily and clearly identify which substance or mixture provided at the refill station the labels correspond to;

RemovedRegulation (EC) No 1272/2008

RemovedAnnex II – paragraph 1 – point 1, Annex II – Part 3 – Section 3.4. – point k – point iv a (new): (iva) Serious eye damage category 1/eye irritation, category 2;

RemovedRegulation (EC) No 1272/2008

RemovedAnnex II – paragraph 1 – point 1, Annex II – Part 3 – Section 3.4. – point k – point v a (new): (va) Skin sensitisation, category 1 (sub-categories 1A and 1B);

RemovedRegulation (EC) No 1272/2008

RemovedAnnex III – paragraph 1 a (new), Annex VI: Annex VI is amended as follows: / "ANNEX VI / — Justification for the proposed grouping of substances to harmonized 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 (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent, very mobile (vPvM), and respiratory sensitisation, a justification that there is a need for action demonstrated at Union level shall be provided. This will not apply for an active substance within the meaning of Regulation (EU) No 1107/2009 or Regulation (EU) No 528/2012."