CMR substances

EU cosmetics legislation contains provisions on the use of substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR substances) in cosmetic products. In general, the use of CMR substances is prohibited, apart from in exceptional cases.

EU rules for CMR substances

Article 15 of the Cosmetics Regulation 1223/2009 contains provisions on the use of CMR in cosmetic products. As a general principle, substances classified as CMR substances of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 are banned for use in cosmetic products. Exceptions to this general rule are possible subject to the conditions laid down in Article 15 of the Cosmetics Regulation.

See the practical guidelines on the procedural steps that economic operators should consider.

EU guidance for the overall exposure assessment of CMR substances in cosmetic products

According to Regulation (EC) N° 1223/2009 on cosmetic products, the safety of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) should be assessed taking account of the exposure from all sources (cosmetics, chemicals, food, medicinal products) according to a comprehensive approach. The EU guidance for overall exposure assessment (19 kB) has been developed in consultation with the scientific committee on consumer safety (SCCS), the European Chemical Agency (ECHA), the European Medicine Agency (EMA) and the European Food Safety Authority (EFSA). It clarifies the respective roles of the industry, the Commission responsible Services, the SCCS and these European agencies for collecting, providing and analysing the exposure data.

CMR: related information

Stakeholders can also follow the discussions on harmonised classification and labelling of substances by following the links from the European Chemicals Agency listed below

• Registry of intentions
• Dossiers submitted
• On-going public consultations on harmonised classification and labelling
• Previous public consultations on harmonised classification and labelling

The upcoming regulatory measures under the CPR, i.e., Omnibus IX on CMR substances, will cover substances newly classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) under the 23^rd Adaptation to Technical Progress (ATP 23) to the CLP Regulation. These substances are listed below.