EU Updates Cosmetics Regulation Annexes II, III, and V

By Percefoni Doufou-Shafiq, Ph.D., senior regulatory specialist, Supply Chain team, UL Solutions 

On Sept. 15, 2022, the EU Commission published Regulation (EU) 2022/1531 amending Cosmetics Regulation (EC)1223/2009, by updating Annexes II, III, and V with regards to the use of certain substances that have been classified as Carcinogenic, Mutagenic or Toxic for Reproduction (CMR).  

Article 15 provision of the Cosmetics Regulation states that substances classified as CMR categories 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CLP) are prohibited from use in cosmetic products. An exception to this provision is laid out in Article 15(1) or Article 15(2) of the Cosmetics Regulation. If certain requirements are met, a CMR substance can still be used in cosmetic products under restrictions.  

The provision of Article 15 of the Cosmetics Regulation ensures uniformity on implementation of legislation regarding CMR substances, provides legal certainty to competent authorities and economic operators, and protects human health. The newest amendment to the Cosmetics Regulation, (EU) 2022/1531, covers substances classified as CMR categories 1A, 1B, or 2 in Commission Regulation (EU) 2021/849 amending Part 3 of Annex VI of the CLP.

Annex II of the Cosmetics Regulation (substances prohibited from use in cosmetic products) has been updated by the addition of 14 substances. Substance Sodium N-(hydroxymethyl)glycinate (CAS No 70161-44-3), classified under certain conditions as Carcinogenic category 1B and Mutagenic category 2 per (EU)2020/1182 amendment to CLP and previously listed in Annex II as entry 1669, is now deleted from the Annex. The substance was erroneously listed in both Annex II and V, and it is not permitted for a substance to be listed in both Annexes.

The entry for Sodium N-(hydroxymethyl)glycinate in Annex V (entry 51) of the Cosmetics Regulation has been corrected to reflect the restrictions based on its conditional CMR classification, therefore the substance can only be used as a preservative in cosmetic products if it can be shown that the concentration of releasable Formaldehyde, irrespective of source, in the mixture as placed on the market is less than 0.1 % w/w.

Methyl salicylate (CAS No 119-36-8), classified as CMR category 2 (Toxic for Reproduction), was exempted from addition to Annex II, based on the second sentence of Article 15(1) of the Cosmetic Regulation, after a request was submitted on May 25, 2021. The exemption was granted because the Scientific Committee on Consumer Safety (SCCS) concluded that Methyl salicylate can be considered safe up to concentrations provided by the applicant regarding its use as a fragrance ingredient in cosmetic products. It is, therefore added to Annex III of the Regulation and can be used under the restrictions prescribed in the Annex.

The additions to Annexes II and III apply from Dec. 17, 2022, whereas the corrections of Annexes II and V apply from Oct. 6, 2022. 

ChemADVISOR^® Regulatory Database from UL Solutions is being updated to reflect the changes.

Sources

• Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
• Amendment (EU) 2022/1531