CMR substances: definition and regulations


Substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR) are subject to strict regulations in the European Union. These regulations are designed to protect the health of consumers. Let's have a look at these substances and their specific regulations in cosmetic products.


What does CMR mean?


Definition of a CMR

CMR substances are chemicals or mixtures that have been classified as carcinogenic, mutagenic or toxic to reproduction. These substances can cause harm to human health if they are inhaled, ingested or applied to the skin. Their effects can be categorised into three main types
  • Carcinogenic: these substances can cause cancer or an increase in the incidence of cancer in exposed individuals.
  • Mutagenic: mutagenic substances can cause genetic mutations that affect the DNA and can lead to hereditary abnormalities that can be passed on to future generations.
  • Reprotoxic: these substances affect reproductive functions and can interfere with fetal development, affecting fertility and reproductive health.


CMR classification 

CMR substances are classified according to their hazard in their pure (undiluted) form and are divided into three different categories:
  • CMR1A: substances for which there is clear evidence that they are carcinogenic, mutagenic or toxic to reproduction.
  • CMR1B: substances for which these effects are possible but for which there is a need for further research for confirmation of the effects.
  • CMR2: substances suspected of having carcinogenic, mutagenic or reprotoxic effects. The risk assessment requires further studies.


Exemples of CMR substances 

For a detailed list of substances that are prohibited in cosmetic products due to their CMR classification (category 1A, 1B or 2), click here.
The CosIng database also provides up-to-date information on regulated substances.


CMR regulations

CMR substances are subject to regulations at the European level, particularly through the CLP Regulation and the Cosmetic Regulation (EC) No 1223/2009, which impose specific restrictions and bans. However, in many countries outside of Europe, CMR regulations are not as harmonized or stringent. This does not necessarily mean the complete absence of regulation, but rather less detailed or specific provisions.


Regulation (EC) No. 1272/2008 - CLP 

The European CLP Regulation sets out the criteria for the classification, labelling and packaging of chemicals, including those classified as CMRs. It applies to all chemicals on the European Union market, whether they are used in cosmetics, industrial products or food. The Regulation requires CMR substances to be labelled appropriately, with clear information on the risks and precautions to be taken. Manufacturers, importers and distributors must assess the risks to human health and the environment, taking into account both professional and public exposure. Based on United Nations international standards, this harmonised system facilitates global trade while ensuring optimal protection of health and the environment.


Regulation (EC) No. 1223/2009 - Cosmetics Products

This regulation is specific to cosmetic products in the EU, setting strict safety, composition, and labelling requirements. 

Substances classified as CMRs in categories 1A and 1B are prohibited in cosmetic products, with certain exceptions. These apply if the substance meets food safety standards (Regulation 178/2002), has no safer alternative, and is considered safe by the Scientific Committee on Consumer Safety (SCCS). An application for a specific use with a clearly defined exposure level must be submitted in such cases. Some substances, like some preservatives or solvents, have been authorised because of their essential role in cosmetic formulations. 

Substances in category 2, suspected of presenting a risk, are also prohibited but some of them may be authorized after SCCS evaluation if deemed safe under specified conditions of use. The European Commission must validate their use. For example, methyl salicylate and salicylic acid were initially classified as category 2 but were authorized at specific concentrations after evaluation.
All cosmetic products must undergo a safety assessment before being marketed. The safety report, prepared by a qualified toxicologist, must analyze risks, including cumulative effects from different sources (cosmetics, food, chemicals, etc.).

Also read our article, Cosmetic PIF: definition and good practices - link to blog article https://www.coptis.com/en/blog/pif-cosmetics-template


Regulation (EU) No. 2023/1490 - Update on Banned Substances

Adopted on July 19, 2023, this regulation strengthens consumer protection by aligning safety standards across different regulatory frameworks. It updates Annex II of Regulation (EC) No. 1223/2009 to include new CMR substances in the list of banned ingredients, based on the latest scientific evidence. The bans are also aligned with the most recent updates to the CLP Regulation's hazard classification. As a result, companies must adjust their formulations and replace banned ingredients with safe alternatives, necessitating a thorough review of their supply chains.


Being proactive in response to evolving CMR regulations in cosmetics

The regulation of CMR substances in cosmetics continues to evolve within the European Union. In June 2024, the European Commission notified the World Trade Organisation (WTO) a proposal for a regulation entitled Omnibus Law VII, which aims to update Regulation (EU) 2024/197. This proposal includes the addition of new CMR substances to the Annexes of Regulation (EC) No 1272/2008 with 23 amendments, including the addition of 21 new banned ingredients and the revision of one previously banned ingredient. Although it is still a proposal, if adopted it will enter into force on 1 September 2025. This will require cosmetic manufacturers and importers to start checking whether their products contain any of these substances and to keep up to date with these regulatory changes.

PLM software like Coptis is an essential asset for cosmetic manufacturers, allowing them to effectively manage regulatory developments and quickly identify any CMR substances present in their formula to ensure the compliance of their products.

Product lifecycle management (PLM) software promotes proactive risk management and ensures compliance with regulatory standards, improving the safety and quality of products throughout their lifecycle.