EU Cosmetics Regulation Annex Updates Regarding CMR Substances

By Percefoni Doufou-Shafiq, Ph.D., Regulatory Affairs Lead, Supply Chain Team, UL Solutions

On Jan. 13, 2026, the EU Commission published Commission Regulation (EU) 2026/78 amending (EC) No 1223/2009 (Cosmetics Regulation) Annexes II, III, IV and V regarding prohibition/restrictions on use of certain substances that have been classified as Carcinogenic, Mutagenic or Toxic to Reproduction (CMR) by Regulation (EC) No 1272/2008 (as amended).

The prohibition or restrictions of these CMR substances is based on Article 15 of the Cosmetics Regulation which states that substances classified as CMR in categories 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CLP) are generally prohibited from use in cosmetic products. In limited cases, CMR substances are still allowed for use under specific restrictions. These substances should meet certain requirements and a request for use by way of exception must be made, as prescribed in Article 15. The newest prohibition/restriction of CMR substances in cosmetic products reflects the CLP amendment (EU) 2024/2564.

Several CMR substances have been added to Annex II (prohibited from use) of the EU Cosmetics Regulation. Annex II was also amended to merge all entries of Perboric acid and its salts as a group rather than individual substances given their common mode of health risks. In addition, Silver has been classified as a category 2 CMR substance in certain particle sizes and therefore, those particle sizes are prohibited from use. With regards to Silver, Annex IV was also amended to reflect the Scientific Committee on Consumer Safety (SCCS) conclusion that only micron-size particulate Silver (as colorant) can be considered safe under specific conditions. Restrictions of use for micron-size Silver were also added in Annex III. 

For substance Hexyl salicylate, classified as toxic to Reproduction category 2, there was a request for application of Article 15(1) (exemption), and after SCCS concluded that this substance can be considered safe under specific conditions, it is now listed in Annex III with restrictions for use in cosmetic products.

A similar request based on Article 15(1) was made for preservative o-Phenylphenol. The SCCS concluded this substance and its salt, Sodium o-phenylphenate, can be considered safe as preservatives under certain prescribed conditions laid out in Annex V.

The above changes to the Annexes shall apply from May 1, 2026.

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
Regulation (EU) 2026/78