Substances of concern (SoC)

A substance that:

(a) meets the criteria laid down in Article 57 of Regulation (EC) No 1907/2006 and is identified in accordance with Article 59(1) of that Regulation;

(b) is classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 in one of the following hazard classes or hazard categories:

(i) carcinogenicity categories 1 and 2;

(ii) germ cell mutagenicity categories 1 and 2;

(iii) reproductive toxicity categories 1 and 2;

(iv) endocrine disruption for human health categories 1 and 2;

(v) endocrine disruption for the environment categories 1 and 2;

(vi) persistent, mobile and toxic or very persistent, very mobile properties;

(vii) persistent, bioaccumulative and toxic or very persistent, very bioaccumulative properties;

(viii) respiratory sensitisation category 1;

(ix) skin sensitisation category 1;

(x) hazard to the aquatic environment – categories chronic 1 to 4;

(xi) hazardous to the ozone layer;

(xii) specific target organ toxicity – repeated exposure categories 1 and 2;

(xiii) specific target organ toxicity – single exposure categories 1 and 2.