Harmonisation of classification and labelling of substances
1. 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)((a)) respiratory sensitisation, category 1 (Annex I, section 3.4);
(b)((b)) germ cell mutagenicity, category 1A, 1B or 2 (Annex I, section 3.5);
(c)((c)) carcinogenicity, category 1A, 1B or 2 (Annex I, section 3.6);
(d)((d)) reproductive toxicity, category 1A, 1B or 2 (Annex I, section 3.7).
2. 2. A substance that is an active substance in the meaning of Directive 91/414/EEC or Directive 98/8/EC shall normally be subject to harmonised classification and labelling. For such substances, the procedures set out in Article 37, paragraphs 1, 4, 5 and 6 shall apply.
3. 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.