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Classification et réglementation des CMR.

What is the classification and regulation of CMR substances?

In the realm of skincare, it is common to hear about CMR (Carcinogenic, Mutagenic or toxic for Reproduction). The use of these highly controversial substances is strictly regulated and is the subject of several European directives. What legislation governs CMR products? Discover more information on this topic.

Summary
Published February 8, 2024, updated on November 6, 2024, by Pauline, Head of Scientific Communication — 5 min read
Cosmetic regulation

CMR substances, in brief.

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: carcinogenic, mutagenic, and toxic to reproduction. Products that meet these criteria are categorized as "CMR". These designations 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.

What regulations govern CMR substances?

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 on 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 permissions, 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 specific 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 Labor 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 should not exceed certain occupational exposure limit values (OELVs) listed in Articles R. 4412-149 and R. 4412-150 of the Labor 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).

How to Identify CMR Substances?

Individuals working in the cosmetic industry and potentially exposed to CMR substances must know how to identify them. To do this, one must pay attention to various pictograms and inscriptions on the packaging. The presence of CMR substances 1A or 1B is indicated by the word "Danger" along 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.

Sources

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

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

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

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