EU Updates Annex II to Cosmetics Regulation

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

On July 19, 2023, the EU Commission published Regulation (EU) 2023/1490 amending Cosmetics Regulation (EC)1223/2009, by updating Annex II with regards to the use of certain substances that have been classified as Carcinogenic, Mutagenic or Toxic for Reproduction (CMR).

The amendment is based on the provision of Article 15 of the Cosmetics Regulation which 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. The use of CMR substances can still be allowed when certain requirements are met and a request for use by way of exception has been made, in which case these substances can be used in cosmetic products under certain 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) 2023/1490, covers substances classified as CMR categories 1A, 1B, or 2 in Commission Regulation (EU) 2022/692 amending Part 3 of Annex VI of the CLP. No exceptions were requested for these substances for use in cosmetic products. The amendment includes an update of entry 1024 of Annex II to the Cosmetics Regulation adding the prohibition of salts of 2-Ethylhexanoic acid (CAS No 149-57-5) as part of the entry. Furthermore, 29 new substances are added to Annex II of the Cosmetics Regulation. The updates shall apply from Dec. 1, 2023.

UL’s ChemADVISOR™ Regulatory Database is being updated to reflect the changes.

References

• Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
• Amendment (EU) 2023/1490