CMR substances and amending Regulation (EC) No 1223/2009 of the European Parliament

CMR substances are classified into three categories (CMR 1ACMR 1B, and CMR 2) based on the strength of scientific evidence for their harmful effects. 

  • CMR 1A: Substances with proven effects in humans.
  • CMR 1B: Substances with presumed effects, based on animal studies.
  • CMR 2: Substances that are suspected of having these effects based on limited human or animal evidence. 

According to article 15 of Regulation (EC) No 1223/2009, substances which have been classified as CMR substances of category 1A, 1B or 2, are to be prohibited from use in cosmetic products. A CMR substance may however be used in cosmetic products where the conditions laid down in Article 15(1), or in Article 15(2) are fulfilled

The substance ‘diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide’ (CAS No: 75980-60-8), is listed in entry 311 of Annex III to Regulation (EC) No 1223/2009 and is, therefore, allowed for professional use in artificial nail systems with a maximum concentration of 5 %.

Also, in light of the classification of ‘Trimethylbenzoyl Diphenylphosphine Oxide’ as a CMR substance of category 1B (Toxic for Reproduction), that substance should no longer be allowed in cosmetic products

The substance with the ISO name ‘cymoxanil’ (CAS No: 57966-95-7), which has been classified as Toxic for Reproduction of Category 2 is, therefore, prohibited for use in cosmetic products.

This Regulation covers substances classified as CMR substances and it will apply from 1 September 2025.

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