Version in force , Modified +42 −16§
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 (c) of Article 38(1) now also lists acute toxicity estimates alongside specific concentration limits and M-factors as items to be specified where applicable, whereas the earlier version referred only to specific concentration limits or M-factors.
Cited: Art. 38, v1 (external, EUR-Lex) · Art. 38, 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 38
Content of opinions and decisions for harmonised classification and labelling in Part 3 of Annex VI; accessibility of information
1. Any opinion referred to in Article 37(4) and any decision according to Article 37(5) shall at least specify for each substance:
(a) the identity of the substance as specified in sections 2.1 to 2.3.4 of Annex VI to Regulation (EC) No 1907/2006;
(b) the classification of the substance referred to in Article 36, including a statement of reasons;
(c) the specific concentration limits limits, M-factors or M-factors, acute toxicity estimates, where applicable;
(d) the label elements specified in points (d), (e) and (f) of Article 17(1) for the substance, together with any supplemental hazard statements for the substance, determined in accordance with Article 25(1);
(e) any other parameter enabling an assessment to be made of the health or environmental hazard of mixtures containing the hazardous substance in question or of substances containing such hazardous substances as identified impurities, additives and constituents, if relevant.
2. When making publicly available an opinion or a decision as referred to in Article 37(4) and (5) of this Regulation, Article 118(2) and Article 119 of Regulation (EC) No 1907/2006 shall apply.