Before I launch into the new substances for 2023 lets talk about what a CMR substance is and how it correlates to the cosmetic regulation in the European Union.
CMR is a European classification of substances that stands for carcinogenic, mutagenic, and reproductive substances. There are three categories of CMR substances: 1A, 1B, and 2.
Category 1A: Substances that are known to be CMR based on human evidence.
Category 1B: Substances that are presumed to be CMR based on animal studies.
Category 2: Substances that are suspected to be CMR from limited evidence based on human or animal studies.
These classifications can be found in Annex VI of the CLP Regulation EC 1272/2008. It can be confusing since the CLP does not commonly apply to cosmetic products; however, if a substance is listed as a CMR substance then they do affect cosmetics.
In the European Cosmetic Regulation (EC No 1223/2009) Article 15 states that the use of CMR substances 1A and 1B are prohibited for use in cosmetics. There are some exceptions; however, all of the criteria listed in the regulation must be met.
Exception criteria:
- Substances must comply with the food safety requirements as defined in Regulation (EC No 178/2002).
- There are no suitable alternative substances.
- The application is made for a particular use of the product category with a known exposure.
- They have been evaluated and found safe by the SCCS for use in cosmetic products.
CMR substances in category 2 are also prohibited; however, they may be used in cosmetic products if the substance has been evaluated by the SCCS and found safe for use in cosmetic products.
This is why when we see that the European Commission has published an Adaptation to Technical Progress (ATP) to regulation EC No 1272/2008 CLP Regulation (CLP being the Classification, Labeling, and Packaging regulations for consumer products) it causes us to take notice due to the possibility of CMR classifications being put onto cosmetic substances, which can prohibit them from use.
New Substances for 2023
On May 3, 2022 the 18th ATP was published by the European Commission and will be adopted into Annex VI of the CLP on November 23, 2023.
Substances that are being classified into category 1B:
Benzophenone CAS 119-61-9
Pentic Acid CAS 67-43-6
Theophylline CAS 58-55-9
Substances that are being classified into category 2:
Melamine CAS 108-78-1
Azadirachta Indica Extract CAS 84696-25-3
Trimethylolpropane Triacrylate CAS 15625-89-5
There are other cosmetic substances on the list; however, they were not categorized as CMR substances so I did not include them in this discussion.
Contact me if you need more information or help figuring out if your products are EU ready.
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