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.’;
39.
“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;
40.
“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;
41.
“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.
4. For the evaluation of a substance containing more than one constituent pursuant to Chapter 2 in relation to the “germ cell mutagenicity”, “carcinogenicity”, “reproductive toxicity”, “endocrine disruption for human health” and “endocrine disruption for the environment” hazard classes referred to in sections 3.5, 3.6, 3.7, 3.11 and 4.2 of Annex I, the manufacturer, importer and downstream user shall use the relevant available information referred to in paragraph 1 for each of the known constituents.
Relevant available information on a substance containing more than one constituent itself shall be taken into account where one of the following conditions is met:
(a)
the information demonstrates germ cell mutagenic, carcinogenic, or toxic to reproduction properties, or endocrine disruption for human health or the environment;
(b)
the information supports the conclusions based on the relevant available information on the constituents in the substance.
Relevant available information on the substance containing more than one constituent itself demonstrating an absence of the properties referred to in point (a) or less severe properties shall not override the relevant available information on the constituents in the substance.
5. For the evaluation of a substance containing more than one constituent pursuant to Chapter 2 of this Title in relation to the biodegradation, persistence, mobility and bioaccumulation properties within the “hazardous to the aquatic environment”, “persistent, bioaccumulative and toxic or very persistent, very bioaccumulative properties” and “persistent, mobile and toxic or very persistent, very mobile properties” hazard classes referred to in sections 4.1.2.8, 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I, the manufacturer, importer and downstream user shall use the relevant available information referred to in paragraph 1 for each of the known constituents in the substance.
Relevant available information on a substance containing more than one constituent itself shall be taken into account where one of the following conditions is met:
(a)
the information demonstrates persistence, mobility and bioaccumulation properties or a lack of degradation.
(b)
the information supports the conclusions based on the relevant available information on the constituents in the substance.
Relevant available information on the substance containing more than one constituent itself demonstrating an absence of the properties referred to in point (a) or less severe properties shall not override the relevant available information on the constituents in the substance.
6. Paragraphs 4 and 5 shall not apply to substances containing more than one constituent which are extracted from plants or plant parts and which are not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006.
7. For the purpose of paragraph 6, “plants” refers to living or dead organisms from the kingdoms Plantae and Fungi, and includes algae, lichens and yeasts.
8. For certain substances containing more than one constituent that are not covered by paragraph 6, where the Commission receives evidence that the rules set out in paragraphs 4 or 5 might not be suitable for certain substances containing more than one constituent, the Commission may request the Agency to evaluate the available data.
The Commission is empowered to adopt delegated acts in accordance with Article 53a to amend Annex I by creating a new section and by including and modifying, in that section, the derogations from paragraph 4 or 5 on classification of substances containing more than one constituent. For those delegated acts, the Commission shall take into account scientific evidence, advances in knowledge, and the opinion of the Agency when available, to appropriately classify substances containing more than one constituent provided that a high level of protection of human health and the environment is ensured.’
;
(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.
4. For the evaluation of mixtures pursuant to Chapter 2 of this Title in relation to the biodegradation, persistency, mobility and bioaccumulation properties within the “hazardous to the aquatic environment”, “persistent, bioaccumulative and toxic or very persistent, very bioaccumulative properties” and “persistent, mobile and toxic or very persistent, very mobile properties” hazard classes referred to in sections 4.1.2.8, 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I, the manufacturer, importer and downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture and not for the mixture itself.’
;
(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.
4. When evaluating hazard information for mixtures, manufacturers, importers and downstream users shall, where test data for the mixture itself are inadequate or unavailable, apply the bridging principles referred to in section 1.1.3 of Annex I and in each section of Parts 3 and 4 of that Annex for the purposes of the evaluation.
If more than one similar tested mixture is available when applying the bridging principles, manufacturers, importers and downstream users shall apply a weight of evidence determination using expert judgement in accordance with section 1.1.1 of Annex I to this Regulation, weighing all available information having a bearing on the determination of the hazards of the mixture, and in accordance with section 1.2 of Annex XI to Regulation (EC) No 1907/2006, to select the most suitable similar tested mixtures in accordance with Article 6(5) of this Regulation for their decision on classification.
When evaluating the hazard information for mixtures, manufacturers, importers and downstream users shall, where that information does not permit the application of the bridging principles in accordance with the first and second subparagraphs, evaluate the information by applying the other method or methods set out in Parts 3 and 4 of Annex I.’
;
(7)
Article 10 is replaced by the following:
‘Article 10
Concentration limits, M-factors and acute toxicity estimates for classification of substances and mixtures
1. Specific concentration limits and generic concentration limits are limits assigned to a substance indicating a threshold at or above which the presence of that substance in another substance or in a mixture as an identified impurity, additive or individual constituent leads to the classification of the substance or mixture as hazardous.
Specific concentration limits shall be set by the manufacturer, importer or downstream user where adequate and reliable scientific information shows that the hazard of a substance is evident when that substance is present at a level below the concentrations set for any hazard class in Part 2 of Annex I or below the generic concentration limits set for any hazard class in Parts 3, 4 and 5 of Annex I.
Manufacturers, importers and downstream users may set a specific concentration limit for a substance in exceptional circumstances where adequate, reliable and conclusive scientific information shows that the hazard of a substance classified as hazardous is not evident at a level above the concentrations set for the relevant hazard class in Part 2 of Annex I or above the generic concentration limits set for the relevant hazard class in Parts 3, 4 and 5 of that Annex.
2. Manufacturers, importers and downstream users shall establish M-factors for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1.
3. Manufacturers, importers and downstream users shall establish acute toxicity estimates for substances classified as acutely toxic for human health.
4. By way of derogation from paragraph 1, second and third subparagraphs, specific concentration limits shall not be set for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI.
5. By way of derogation from paragraph 2, M-factors shall not be established for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI for which an M-factor is given in that Part.
However, where an M-factor is not given in Part 3 of Annex VI for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1, the manufacturer, importer or downstream user shall set an M-factor based on available data for the substance. When a mixture including the substance is classified by the manufacturer, importer or downstream user using the summation method, that M-factor shall be used.
6. By way of derogation from paragraph 3, acute toxicity estimates shall not be established for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI for which an acute toxicity estimate is given in that Part.
7. When setting the specific concentration limit, M-factor or acute toxicity estimate, manufacturers, importers and downstream users shall take into account any specific concentration limits, M-factors or acute toxicity estimate for that substance which have been included in the classification and labelling inventory.
8. Specific concentration limits set in accordance with paragraph 1, second and third subparagraphs, shall take precedence over the concentration limits set out in the relevant sections of Part 2 of Annex I or the generic concentration limits for classification set out in the relevant sections of Parts 3, 4 and 5 of that Annex.
9. The Agency shall provide further guidance for the application of paragraphs 1, 2 and 3.
10. Where a mixture contains a substance which is classified as hazardous solely due to the presence of an identified impurity, additive or individual constituent, the concentration limits referred to in paragraph 1, second and third subparagraphs, shall apply to the concentration of that identified impurity, additive or individual constituent in the mixture.
11. Where a mixture contains another mixture, the concentration limits referred to in paragraph 1, second and third subparagraphs, shall apply to the concentration of the identified impurity, additive or individual constituent referred to in paragraph 10 in the resulting final mixture.’
;
(8)
Article 13 is replaced by the following:
‘Article 13
Decision to classify substances and mixtures
If the evaluation undertaken pursuant to Articles 9 and 12 shows that the hazards associated with the substance or mixture meet the criteria for classification in one or more hazard classes or differentiations in Parts 2 to 5 of Annex I, manufacturers, importers and downstream users shall classify the substance or mixture or, if scientifically justified, specific forms or physical states thereof, in relation to the relevant hazard class or classes or differentiations by assigning the following:
(a)
one or more hazard categories for each relevant hazard class or differentiation;
(b)
subject to Article 21, one or more hazard statements corresponding to each hazard category assigned in accordance with point (a).’
;
(9)
in Article 18(3), point (b) is replaced by the following:
‘(b)
the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity, aspiration hazard, persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic, very persistent and very mobile properties, or endocrine disruption for human health or the environment.’
;
(10)
in Article 23, the following point is added:
‘(g)
ammunition as defined in Article 1(1), point (3), of Directive (EU) 2021/555 of the European Parliament and of the Council ( *1 ) unless it is an article that falls within the scope of Article 4(8) of this Regulation.
( *1 ) Directive (EU) 2021/555 of the European Parliament and of the Council of 24 March 2021 on control of the acquisition and possession of weapons ( OJ L 115, 6.4.2021, p. 1 ).’;"
(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
1. In the event of a change regarding the classification or labelling of a substance or a mixture, which results in the addition of a new hazard class or in a more severe classification, or which requires new supplemental information on the label in accordance with Article 25, the supplier of that substance or that mixture shall ensure that the label is updated without undue delay and in any event no later than 6 months after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.
2. Where a change regarding the classification or labelling of a substance or a mixture, other than those referred to in paragraph 1 of this Article, is required, the supplier of that substance or that mixture shall ensure that the label is updated without undue delay and in any event no later than 18 months after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.
3. Paragraphs 1 and 2 shall not apply where a change regarding the classification and labelling of a substance or a mixture was triggered by a harmonised classification and labelling of a substance set out in a delegated act adopted pursuant to Article 37(5) or by a provision set out in a delegated act adopted pursuant to Article 53(1). In such cases, the supplier shall ensure that the label is updated by the date set out in the respective delegated act.
4. The supplier of a substance or mixture that falls within the scope of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 shall update the label in accordance with those Regulations’
;
(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
Article 34a
Physical and digital labelling
1. The label elements for substances and mixtures referred to in Article 17 shall be provided on a label in a physical form (“physical label”). In addition to the physical label, the label elements referred to in Article 17 may be provided in a digital form (“digital label”).
2. By way of derogation from paragraph 1, suppliers may provide the label elements set out in section 1.6 of Annex I on a digital label only.
Where the label elements set out in section 1.6 of Annex I are provided on a digital label only, suppliers shall, upon oral or written request or when the digital label is temporarily unavailable at the time of purchase of the substance or mixture, provide those label elements by alternative means. Suppliers shall provide those elements independently of a purchase and free of charge.
3. Where the information is provided through a digital label, the requirements for digital labels set out in Article 34b shall apply.
Article 34b
Requirements for digital labelling
1. Where, pursuant to Article 31(1b), a supplier affixes or prints a data carrier linking to a digital label, that supplier shall ensure that the digital label satisfies the following general rules and technical requirements:
(a)
all label elements referred to in Article 17(1) shall be provided together in one place and separately from other information;
(b)
the information on the digital label shall be searchable;
(c)
the information on the digital label shall be accessible to all users in the Union and shall remain accessible for a period of at least 10 years or for a longer period where required by other Union legislation;
(d)
the digital label shall be accessible free of charge, without the need to register or to download or install applications, or to provide a password;
(e)
the information on the digital label shall be presented in a way that also addresses the needs of vulnerable groups and supports, as relevant, the necessary adaptations to facilitate access to the information by those groups;
(f)
the information on the digital label shall be accessible with no more than two clicks;
(g)
the digital label shall be accessible through digital technologies widely used, and compatible with all major operating systems and browsers;
(h)
where the information on the digital label is accessible in more than one language, the choice of language shall not be conditioned by the geographical location from which that information is accessed.
2. It shall be prohibited to track, analyse or use any usage information for purposes going beyond what is absolutely necessary for the provision of digital labelling.’
;
(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.
6. Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling 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.’
;
(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.
8. In the case of a proposal for harmonised classification and labelling of a group of substances, those substances shall be grouped together on the basis of clear scientific reasoning taking into account how the available information supports the grouping of substances and allows the property or properties of the substance or substances to be reliably predicted from information on other substances in the group.’
;
(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
1. Any advertisement for a substance classified as hazardous shall indicate, as applicable, the hazard pictograms, signal words, hazard statements and supplemental EUH statements set out in Annex II. Any advertisement for such a substance for sale to the general public shall in addition state: “Always follow the information on the product label.”.
2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) shall indicate the hazard pictograms, signal words, hazard statements and supplemental EUH statements set out in Annex II. Any advertisement for such a mixture for sale to the general public shall, in addition, state: “Always follow the information on the product label.”.
3. Any advertisement for a substance or a mixture classified as hazardous shall not contain statements that are not to appear on the label or packaging of that substance or mixture in accordance with Article 25(4).
4. By way of derogation from paragraphs 1 and 2, the hazard pictograms and signal words may be omitted where the advertisement is non-visual.’
;
(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.
4. The Agency shall be provided with adequate resources to support its work.’
;
(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.
3. The delegation of power referred to in Article 5(8), Article 37(5) and(7), Article 45(4), and Article 53(1), (1a), (1b) and (3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.’
;
(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 ( *2 ) .
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
( *2 ) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers ( OJ L 55, 28.2.2011, p. 13 ).’;"
(34)
the following article is added:
‘Article 54a
Reporting and review
1. By 11 December 2029, the Commission shall present a scientific report to the European Parliament and to the Council regarding the examination of the information on substances containing more than one constituent extracted from plants. The report may be accompanied, if appropriate, by a legislative proposal.
2. By 11 December 2029, the Commission shall present an evaluation report to the European Parliament, the Council and the European Economic and Social Committee, assessing the need to extend requirements in sections 3.1 and 3.2 of Annex II on child-resistant fastenings and tactile warnings to other hazard classes. If justified by the results of the report, the Commission shall act in accordance with Article 53(1).’
;
(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 ( *3 ) until 1 July 2028.
8. Substances and mixtures which have been classified, labelled and packaged in accordance with Article 18(3), Article 31(3) and section 1.2.1 of Annex I, as applicable on 9 December 2024 and which were placed on the market before 1 January 2027 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 ( *3 ) until 1 January 2029.
’
( *3 ) Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures ( OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj )"
( *3 ) Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures ( OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj )"
;
(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.