CMR Substances (CMR)

CMR substances are those classified as Carcinogenic, Mutagenic, or toxic to Reproduction under the EU Classification, Labelling and Packaging Regulation (CLP, EC 1272/2008). The EU Cosmetics Regulation (EC 1223/2009) generally prohibits the use of CMR substances in cosmetic products (Article 15).

CMR classification is categorized by severity: Category 1A (known to have CMR effects in humans, based on human evidence), Category 1B (presumed to have CMR effects in humans, based on animal studies), and Category 2 (suspected of having CMR effects). All three categories are addressed in the cosmetics regulation.

The general prohibition on CMR substances in cosmetics has very limited exceptions outlined in Article 15(1) and (2). A CMR substance may be used if it has been evaluated by the SCCS and found safe for use in cosmetic products, and subsequently authorized by the European Commission with specific conditions. Alternatively, a CMR category 2 substance may be temporarily used if it has been evaluated and found safe by the SCCS, subject to a specific Commission decision.

When a substance is newly classified as CMR under CLP, it is automatically prohibited in cosmetics. The Responsible Person must notify the presence of CMR substances in the CPNP notification. Products containing CMR substances in violation of the regulation must be withdrawn from the market immediately.