EU Updates Annexes II and III to Cosmetics Regulation

By Percefoni Doufou-Shafiq, Ph.D., regulatory affairs lead, Supply Chain Team, UL Solutions

On May 12, 2025, the EU Commission published Commission Regulation (EU) 2025/877 amending Cosmetics Regulation (EC) No 1223/2009, by updating Annexes II (substances prohibited for use in cosmetics) and III (substances allowed to be used with restrictions) with regards to the use of certain substances classified as Carcinogenic, Mutagenic or Toxic to Reproduction (CMR).

According to Article 15 of the Cosmetics Regulation (EC) No 1223/2009, substances classified as CMR in 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. In limited cases, CMR substances can still be used under restrictions provided in Annex III to the Cosmetics Regulation. Such substances should meet certain requirements and a request for use by way of exception must be made, as prescribed in Article 15. The provisions of Article 15 of the Cosmetics Regulation ensure uniformity on implementation of legislation regarding CMR substances, provide legal certainty to competent authorities and economic operators, and protect human health.

Amendment (EU) 2025/877 covers substances classified as CMR according to the Delegated Regulation (EU) 2024/197 amending the CLP Regulation (EC) No 1272/2008. For the CMR substances included in the present Cosmetics Regulation amendment, no request for exception was made.

Annex II to the Cosmetics Regulation is updated by including 20 new substances listed with reference numbers between 1731 and 1751. In addition, the existing entry with reference number 1580 is updated by adding the chemical name (2E)-2-Cyano-N-[(ethylamine)carbonyl]- 2-(methoxyimino)acetamide (CAS 166900-80-7) to the existing entry.

Annex III to the Cosmetics Regulation is amended by deletion of substance Trimethyl benzoyl diphenylphosphine oxide (entry 311 in Annex III). This substance is classified as a CMR substance category 1B (toxic to reproduction) and therefore is prohibited from use and has moved to Annex II.

Regulation (EU) 2025/877 shall apply from Sep. 1, 2025.

UL Solutions’ 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

Regulation (EU) 2025/877