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‘substance of concern’ means a substance that: 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; is classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 in one of the following hazard classes or hazard categories: carcinogenicity categories 1 and 2; germ cell mutagenicity categories 1 and 2; reproductive toxicity categories 1 and 2; endocrine disruption for human health categories 1 and 2; endocrine disruption for the environment categories 1 and 2; persistent, mobile and toxic or very persistent, very mobile properties; persistent, bioaccumulative and toxic or very persistent, very bioaccumulative properties; respiratory sensitisation category 1; skin sensitisation category 1; hazardous to the aquatic environment — categories chronic 1 to 4; hazardous to the ozone layer; specific target organ toxicity — repeated exposure categories 1 and 2; specific target organ toxicity — single exposure categories 1 and 2; is regulated under Regulation (EU) 2019/1021; or negatively affects the reuse and recycling of materials in the product in which it is present;

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Source: EUR-Lex (Cellar) · retrieved 2026-10-12 · Text as adopted (Official Journal); later amendments are not incorporated in this text.