What is the classification and regulation of CMR substances?

It is well-known that not all ingredients used in skincare are risk-free. Certain chemical substances, whether alone or in combination, can be harmful to health: cancer-causing, mutagenic and toxic to reproduction. Products that meet these criteria are categorised as "CMR". These labels are subject to strict definitions established by ANSES (French Agency for Food, Environmental and Occupational Health & Safety) and the European REACH regulation (Registration Evaluation Authorization of Chemicals), whose role is to protect human health and the environment from risks associated with chemical substances.

• Carcinogens (C): substances and mixtures that, through inhalation, ingestion, or skin penetration, can cause cancer or increase its frequency;

• Mutagens (M): substances and mixtures that, through inhalation, ingestion or skin penetration, can produce hereditary genetic defects or increase their frequency;

• Reproductive Toxins (R): substances and mixtures that, through inhalation, ingestion or skin penetration, can produce or increase the frequency of non-heritable harmful effects in offspring or impair reproductive functions or capabilities.

CMR substances are classified by the European CLP regulation into three categories of effects: CMR 1A, CMR 1B and CMR 2. CMR 1A are substances whose carcinogenic/mutagenic/toxic potential for humans is proven, CMR 1B are substances whose carcinogenic/mutagenic/toxic potential is presumed and CMR 2 are substances of concern because they are suspected to have a carcinogenic/mutagenic/toxic potential.

Given the danger of CMR substances and mixtures to health, their use is strictly regulated. In Europe, Regulation No 1223/2009 concerning the use of cosmetics governs this to protect consumer health. This regulation prohibits the use of substances classified as CMR with certain exceptions, deemed safe by the SCCS or European Scientific Committee for Consumer Safety. Indeed, it has been assessed that a dangerous property of a substance does not necessarily entail a risk in its use. This is the case for certain category 2 CMR substances such as acetamide.

Furthermore, certain CMR substances of categories 1A or 1B such as acetaldehyde can also be used in cosmetic products. The authorisations, however, remain exceptional and the following conditions must be adhered to:

• The substance must comply with the European regulation on foodstuffs 178/2008 and its amendments;

• There must not exist any suitable substitute product;

• The CMR substance must be used for a specific purpose;

• The SCCS must have given a positive assessment for a specified use.

The handling of CMR substances is also regulated in order to protect workers. Preventive measures are notably stated in Article L4121-2 of the Labour Code. This includes measures for risk assessment, priority safety measures and hygiene for the development of sun care products, among others. Workers' exposure must be regularly monitored and must not exceed certain occupational exposure limit values (OELVs) listed in Articles R. 4412-149 and R. 4412-150 of the Labour Code. Furthermore, exposed workers must receive training on the risks and precautions to be taken, hygiene and emergency measures, as well as the use of individual and collective protective equipment (PPE and CPE).

Individuals working in the cosmetics industry and potentially exposed to CMR substances must know how to identify them. To do this, attention must be paid to various pictograms and inscriptions on the packaging. The presence of CMR substances 1A or 1B is indicated by the word "Danger" with the inscriptions H350, H340 or H360. A "Caution" pictogram is used to warn of the use of category 2 CMR substances, but with the notations H351, H341 or H361.

Good to know : At Typology, we do not use any substances classified as CMR, as defined in our formulation charter.

• Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

• Regulation (EC) No 1272/2008 of the European Parliament and of the Council concerning the classification, labelling and packaging of chemical substances and mixtures (CLP).

• Regulation (EC) No 1223/2009 of the European Parliament and of the Council. Official Journal of the European Union (2009).