Tuesday, September 1, 2020European Commission

α- and β-arbutin: call for data from the European Commission

α- et β-arbutin : appel à données de la Commission européenne

As the European Commission has concerns about their use in cosmetic products, in particular due to inconsistencies and data gaps, it invites all interested parties to submit any relevant scientific information with a view to a new mandate to the SCCS for the assessment of their safety. This call for data is open until 27 April 2021.

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α-arbutin (INCI name: Alpha-Arbutin, Chemical name: 4-Hydroxyphenyl-alpha-D-glucopyranoside, CAS No.84380-01-8, EC No.617-561-8) and the structurally related compound (optical isomer) β-arbutin (INCI Name: Arbutin, Chemical name: 4-Hydroxyphenyl-b-D-glucopyranoside, CAS No.497-76-7, EC No.207-850-3) are similar cosmetic ingredients currently not regulated under the Cosmetic Regulation (EC) No.1223/2009. Among the reported functions for both α- and β-arbutin are antioxidant, skin bleaching and skin conditioning.

The safety of α-arbutin and β-arbutin has been previously assessed in the SCCS/1552/15 and SCCS/1550/15, respectively. Their effects could be attributed to the fact that they are hydrolysed to hydroquinone (HQ). Hydroquinone (CAS No.123-31-9) is listed in entry 1339 of Annex II to the Cosmetic Regulation. This means that it is prohibited as a cosmetic ingredient except for entry 14 in Annex III (restricting its use to professionals in artificial nail systems with a maximum concentration up to 0.02% in the finished product).

In the relevant SCCS Opinions (SCCS/1552/15 and SCCS/1550/15), the SCCS concluded that:
1. The use of α-arbutin in cosmetic products is safe for consumers when its concentration is up to 2% in face creams and up to 0.5 % in body lotions
2. the use of β-arbutin in cosmetic products is safe for consumers when its concentration is …

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