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Monday, April 4, 2022Regulation

α- and β-arbutin: Preliminary Opinion of the SCCS

α- et β-arbutin : Opinion préliminaire du CSSC

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 Preliminary Opinion on α- and β-arbutin. It was adopted at the plenary meeting of the Scientific Committee on 15-16 March 2022, and is open for comment until 27 May 2022.

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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.

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

Opinion

1. In light of the data provided, does the SCCS consider α-Arbutin safe when used in face creams up to a maximum concentration of 2% and in body lotions up to a maximum concentration of 0.5 %?

Having considered the data provided, and other relevant information available in scientific literature, the SCCS …

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