What are the regulations on the use of CMR (Carcinogenic, Mutagenic and Reprotoxic) substances?

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).

What is a CMR substance or agent?

Substances are considered to be CMR if they produce one or more of the following effects when inhaled, ingested or applied by dermal penetration:

• A carcinogenic effect: that is to say, may cause or increase the frequency of cancer.
• A mutagenic effect: that is to say, may produce hereditary genetic defects or increase their frequency.
• A reprotoxic effect: that is to say, may produce or increase the frequency of non-hereditary adverse effects in offspring or impair reproductive functions or abilities.

CMR substance classifications

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:

• Category 1A substances (proven effect)
• Category 1B substances (presumed effect)
• Category 2 substances (suspected effect)

Which substances are automatically prohibited?

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.

Are there any possible exemptions to this?

In exceptional circumstances, it is however possible for CMR substances to be used in cosmetic products under certain conditions.

For CMR substances classified as category 2

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.

For CMR substances classified as categories 1A and 1B

These substances may be used, on an exceptional basic, under four (4) conditions:

• Compliance with European Food Regulation 178/2008 (and amendments)
• No suitable alternative substances
• Use for a specific purpose
• Approval by the Scientific Committee on Consumer Safety (SCCS) for a determined exposure.