# Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance), Article 36: Mandatory classification and labelling of substances

Extent: E+W+S+N.I.

1. A substance that fulfils the criteria set out in Annex I for the following shall normally be subject to mandatory classification and labelling in accordance with Article 37 ...:
(a) respiratory sensitisation, category 1 (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).
2. A substance that is an active substance in the meaning of Regulation (EC) No 1107/2009 or Regulation (EC) No 528/2012 shall normally be subject to mandatory classification and labelling. For such substances, the procedures set out in Article 37 ..., ... 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 mandatory classification and labelling requirement in accordance with Article 37 ... may also be added to the GB mandatory classification and labelling list on a case-by-case basis, if justification is provided demonstrating the need for such action ....

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Source: https://www.legislation.gov.uk/eur/2008/1272/article/36 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-1272/article-36
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.