EU Updates Annexes II and III to Cosmetics Regulation

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

On March 14, 2024, the EU Commission published Regulation (EU) 2024/858 amending Cosmetics Regulation (EC) No 1223/2009, which updated Annexes II and III regarding the use of certain nanomaterials in cosmetic products. Substances added in Annex II are prohibited from use, whereas those added in Annex III can be used when prescribed restrictions are met.

Article 16 of the EU Cosmetics Regulation stipulates that nanomaterials used in cosmetic products should not compromise human health. If the Commission has concerns about the use of a nanomaterial in a cosmetic product, it requests the opinion of the Scientific Committee on Consumer Safety (SCCS) on the safety of the nanomaterial substance. Amendment (EU) 2024/858 reflects SCCS opinions published on the safety of several substances in nanomaterial form.

For some of these substances, it was concluded that because of their physiochemical, toxicological and exposure aspects, they pose health risks to consumers. For other nanomaterials, the SCCS could not carry out a complete safety assessment due to limited or missing crucial information. In addition, the SCCS concluded for certain nanomaterials with limited information available, that the possibility of accumulation in certain organs, and their potential mutagenic/genotoxic and immunotoxic/nephrotoxic effects warrants concern for their use. These nanomaterial substances are therefore, according to (EU) 2024/858, prohibited and are listed in Annex II of the Cosmetics Regulation.

For substance Hydroxyapatite (nano), the SCCS concluded that it is safe when used in specifically composed nanomaterial form and at concentrations up to 10% in toothpaste, and up to 0.465% in mouthwash. Because no data was available to assess the inhalation risk of this nanomaterial, it is not allowed in sprayable products. This substance is added to the Annex III of the EU Cosmetics Regulation.

There is a grace period for industry to adapt to the new requirements, make necessary changes to formulations, and withdraw non-compliant products from the market. New products should not be placed on the market from Feb. 1, 2025, whereas existing products should not be made available in the market from Nov. 1, 2025.

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

(EU) 2024/858

SCCS Opinions