Art. 37 · Procedure for harmonisation of classification and labelling of substances

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Previous version, in force 1 December 2023 02008R1272-20231201

Article 37
Procedure for harmonisation of classification and labelling of substances
1. A competent authority may submit to the Agency a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits or M-factors, or a proposal for a revision thereof.
The proposal 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.
2. A manufacturer, importer or downstream user of a substance may submit to the Agency a proposal for harmonised classification and labelling of that substance and, where appropriate, specific concentration limits or M-factors, provided that there is no entry in Part 3 of Annex VI for such a substance in relation to the hazard class or differentiation covered by that proposal.
The proposal shall be drawn up in accordance with the relevant Parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 and it shall follow the format set out in Part B of the Chemical Safety Report of section 7 of that Annex. It shall contain the relevant information provided for in Part 1 of Annex VI to this Regulation. Article 111 of Regulation (EC) No 1907/2006 shall apply.
3. Where the proposal of the manufacturer, importer or downstream user concerns the harmonised classification and labelling of a substance in accordance with Article 36(3), it shall be accompanied by the fee determined by the Commission in accordance with the regulatory procedure referred to in Article 54(2).
4. The Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 shall adopt an opinion on any proposal submitted pursuant to paragraphs 1 or 2 within 18 months of receipt of the proposal, giving the parties concerned the opportunity to comment. The Agency shall forward this opinion and any comments to the Commission.
5. The Commission shall without undue delay adopt delegated acts in accordance with Article 53a, where it finds that the harmonisation of the classification and labelling of the substance concerned is appropriate, to amend Annex VI by inclusion of that substance together with the relevant classification and labelling elements in Table 3.1 of Part 3 of Annex VI and, where appropriate, the specific concentration limits or M-factors.
A corresponding entry shall be included in Table 3.2 of Part 3 of Annex VI subject to the same conditions, until 31 May 2015.
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 elements of a substance in Part 3 of Annex VI shall submit a proposal in accordance with the second subparagraph of paragraph 2 to the competent authority in one of the Member States in which the substance is placed on the market.

this version, in force 10 December 2024 02008R1272-20241210

Article 37
Procedure for harmonisation of classification and labelling of substances
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.
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.
2. 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.
The proposal shall be drawn up in accordance with the relevant Parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 and it shall follow the format set out in Part B of the Chemical Safety Report of section 7 of that Annex. It shall contain the relevant information provided for in Part 1 of Annex VI to this Regulation. Article 111 of Regulation (EC) No 1907/2006 shall apply.
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.
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).
4. The Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 shall adopt an opinion on any proposal submitted pursuant to paragraphs 1 or 2 within 18 months of receipt of the proposal, giving the parties concerned the opportunity to comment. The Agency shall forward this opinion and any comments to the Commission.
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.
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.