EU Updates Annexes of Cosmetics Regulation (EC) No 1223/2009

by Percefoni Doufou-Shafiq, senior regulatory specialist, Supply Chain 

On July 5, 2021, the EU published amendment (EU) 2021/1099 to Cosmetics Regulation 1223/2009, updating Annexes II and III of the Regulation. Annex II contains the substances prohibited from use in cosmetic products whereas Annex III contains substances that can be used with restrictions in cosmetic products. 

Annex II to Cosmetics Regulation has been updated with the addition of Deoxyarbutin, an ingredient used as a skin lightening agent and not currently regulated. The prohibition of this substance is based on the June 25, 2015 Opinion of the Scientific Committee on Consumer Safety (SCCS) that  concluded that the use of Deoxyarbutin up to 3% cannot be considered safe in face creams because of Hydroquinone formation which raises concerns for the safety of products during their life cycle (e.g. storage, stability). The amendment took effect after publication in the Official Journal of the European Union on July 6, 2021. 

Annex III to Cosmetics Regulation has been updated with the addition of dihydroxyacetone, an ingredient used as skin conditioning and tanning, with a restricted maximum concentration of 6.25% in non-oxidative hair dye products and 10% in self-tanning products. This restriction is based on the March 3-4, 2020 SCCS Opinion conclusions for dihydroxyacetone. The implementation date for this restriction is January 26, 2022 for new products and April 22, 2022 for existing products.

UL’s ChemADVISOR^® Regulatory Database is being updated to reflect the changes and will be available for the October 2021 release (2021-4) release.

Resources

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products

Amendment (EU) No 2021/1099