Substances of Concern

From Open Risk Manual

Definition

Substances of Concern. Substances of concern means a substance that: a) meets the criteria laid down in Article 57 and is identified in accordance with Article 59(1) of Regulation (EC) No 1907/2006; b) is classified in Part 3 of Annex VI to Regulation (EC) in one of the following hazard classes or hazard categories: – No 1272/2008 – carcinogenicity categories 1 and 2, – germ cell mutagenicity categories 1 and 2, – reproductive toxicity categories 1 and 2, [to be added in the course of the legislative procedure once Regulation (EC) No 1272/2008 contains these hazard classes: Persistent, Bioacumulative, Toxic (PBTs), very Persistent very Bioaccumulative (vPvBs); Persistent, Mobile and Toxic (PMT), very Persistent very Mobile (vPvM); Endocrine disruption], – respiratory sensitisation category 1, – skin sensitisation category 1, – chronic hazard to the aquatic environment categories 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; or c) any other substance that are set out in applicable EU legislation.

In that regard, legislation in the wake of the EU Chemicals Strategy for Sustainability will be of particular importance.