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:
respiratory sensitisation, category 1, 1A or 1B (Annex I, section 3.4);
germ cell mutagenicity, category 1A, 1B or 2 (Annex I, section 3.5);
carcinogenicity, category 1A, 1B or 2 (Annex I, section 3.6);
reproductive toxicity, category 1A, 1B or 2 (Annex I, section 3.7);
endocrine disruption for human health, category 1 or 2 (Annex I, section 3.11);
endocrine disruption for the environment, category 1 or 2 (Annex I, section 4.2);
persistent, bioaccumulative and toxic (Annex I, section 4.3);
very persistent, very bioaccumulative (Annex I, section 4.3);
persistent, mobile and toxic (Annex I, section 4.4);
very persistent, very mobile (Annex I, section 4.4).
2.Substances that are active substances falling within the scope of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 shall be subject to harmonised classification and labelling. For such substances, the procedures set out in Article 37(1), (4), (5) and (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.