Since 1 December 2010, Article 15 (paragraphs 1 and 2) of EU Cosmetics Regulations (EC) has applied to the use of CMR substances. These regulations determine which CMR substances can and cannot be used in a cosmetic product and where applicable, under which conditions.
In order to establish clear regulations concerning their use and ensure a high level of protection as regards human health and the environment, these CMR substances have been classified into 3 categories according to their harmfulness (proven, presumed, or suspected effect).
Substances are considered to be CMR if they produce one or more of the following effects when inhaled, ingested or applied by dermal penetration:
CMR substances are classified into three categories by Regulation EC Nº 1272/2008 of the European Parliament and of the Council of 16 December 2008, in accordance with European classification, labelling and packaging rules.
This classification makes it possible to assess their harmfulness as regards carcinogenicity, mutagenicity and reprotoxicity:
Article 15 of the Cosmetics Regulations (EU) states that CMR substances classified as 1A, 1B and 2 are automatically prohibited if not listed in Annex II of the prohibited substances.
In exceptional circumstances, it is however possible for CMR substances to be used in cosmetic products under certain conditions.
If approved by the Scientific Committee on Consumer Safety (SCCS), these substances may be used in the cosmetic product but must be declared in the lists of authorised or restricted substances.
These substances may be used, on an exceptional basic, under four (4) conditions: