CMR substances are carcinogenic, mutagenic or toxic to reproduction. In the EU they are classified under the CLP Regulation (EC) No 1272/2008 into:
- CMR 1A: known human carcinogen/mutagen/reprotoxic.
- CMR 1B: presumed based on animal data.
- CMR 2: suspected; limited evidence.
In cosmetics, these categories inform prohibitions or strict conditions under the EU Cosmetics Regulation (EC) No 1223/2009.
Under Article 15 of Regulation (EC) No 1223/2009, substances classified as CMR (1A/1B/2) under the CLP are in principle banned in cosmetic products.
Exceptions are limited and require strict conditions, including a positive SCCS opinion on safety for the specific use; some Category 2 substances may be allowed if SCCS confirms safety.
What exceptions really mean:
- A full risk assessment by the SCCS (exposure, margins of safety, specific uses).
- Compliance with other relevant EU laws and no suitable alternative in some cases.
- If allowed, the substance is typically listed/restricted in the Annexes of 1223/2009 (e.g., Annex III).
More than 1750 substances have been included in the list of banned substances to date.
