Version in force , Modified +548 −109§
Amended by Regulation (EU) 2024/2865 32024R2865 on EUR-Lex (external, EUR-Lex)
Explanation, written by a model and checked against the cited text
Point (a) of paragraph 1 now covers respiratory sensitisation category 1, 1A or 1B, replacing the earlier reference to category 1 alone.
Paragraph 1 gains new points (e) through (j), adding hazard classes for endocrine disruption to human health and the environment, persistence/bioaccumulation/toxicity, very persistent/very bioaccumulative, persistent/mobile/toxic, and very persistent/very mobile substances, each tied to a specified Annex I section, alongside the existing points (b) through (d).
Paragraph 2 now refers to active substances falling within the scope of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012, and to Article 37(1), (4), (5) and (6), replacing the prior reference to active substances under Directive 91/414/EEC or Directive 98/8/EC and to Article 37, paragraphs 1, 4, 5 and 6.
Cited: Art. 36, v1 (external, EUR-Lex) · Art. 36, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version, in force 1 December 2023 02008R1272-20231201 → this version, in force 10 December 2024 02008R1272-20241210
Article 36
Harmonisation of classification and labelling of substances
1. A substance that fulfils the criteria set out in Annex I for the following shall normally be subject to harmonised classification and labelling in accordance with Article 37:
(a) respiratory sensitisation, category 1 1, 1A or 1B (Annex I, section 3.4);
(b) germ cell mutagenicity, category 1A, 1B or 2 (Annex I, section 3.5);
(c) carcinogenicity, category 1A, 1B or 2 (Annex I, section 3.6);
(d) reproductive toxicity, category 1A, 1B or 2 (Annex I, section 3.7). 3.7);
(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).
2. A substance Substances that is an are active substance in substances falling within the meaning scope of Directive 91/414/EEC Regulation (EC) No 1107/2009 or Directive 98/8/EC Regulation (EU) No 528/2012 shall normally be subject to harmonised classification and labelling. For such substances, the procedures set out in Article 37, paragraphs 1, 4, 5 37(1), (4), (5) and 6 (6) shall apply.
3. Where a substance fulfils the criteria for other hazard classes or differentiations than those referred to in paragraph 1 and does not fall under paragraph 2, a harmonised classification and labelling in accordance with Article 37 may also be added to Annex VI on a case-by-case basis, if justification is provided demonstrating the need for such action at Community level.