Following the mandate given by the European Commission to the SCCS in June 2021 due to their potential to release Hydroquinone, a substance prohibited by Cosmetic Regulation 1223/2009, the SCCS has just published its final Opinion on α- and β-arbutin. It was adopted by written procedure on 31 January 2023.
Background
alpha-Arbutin and beta-Arbutin are similar cosmetic ingredients currently not regulated by the Cosmetics Regulation (EC) No.1223/2009. Their functions include “antioxidant”, “skin bleaching” and “skin conditioning”.
The effects of arbutins on the skin can be attributed to their progressive hydrolysis and release of Hydroquinone (HQ), which is listed in entry 1339 of Annex II of the Cosmetics Regulation, meaning that it is prohibited as a cosmetic ingredient.
A call for data was launched by the European Commission from July 2020 to April 2021. Interested parties were invited to provide relevant data for the stability of α- and β-Arbutin, their dermal absorption, HQ release rate and overall exposure.
The Scientific Committee issued its preliminary Opinion in March 2022, stating that it could not conclude on the safety or establish safe concentrations for any of the arbutins.
For an exhaustive background information, see the articles
• α- and β-arbutin: call for data from the European Commission, CosmeticOBS, 1st September 2020
• Fullerenes, α- and β-arbutin: Requests for Opinions of the SCCS, CosmeticOBS, 5 July 2021 • α- and β-arbutin: Preliminary Opinion of the SCCS, CosmeticOBS, 4 April 2022
This Opinion has been subject to a commenting period of eight …
