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 11, 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 substanceSubstances that is anare active substancesubstances infalling within the meaningscope of DirectiveRegulation 91/414/EEC(EC) No 1107/2009 or DirectiveRegulation 98/8/EC(EU) No 528/2012 shall normally be subject to harmonised classification and labelling. For such substances, the procedures set out in Article 37,37(1), paragraphs(4), 1, 4, 5(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.