The European Commission has concerns on the potential use of alpha and beta arbutin in cosmetic products, because of inconsistencies and data gaps concerning their safety assessment that were not addressed under previous submissions (SCCS/1550/15 on β-arbutin and SCCS/1552/15 on α-arbutin).
Action Proposed by the Commission
To mandate the Scientific Committee on Consumer Safety (SCCS) on the safety of alpha and beta arbutin, the commission invites interested parties to submit, following the requirements described below, any relevant scientific information on the safety of the following chemicals in cosmetic products:
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'alpha-arbutin' (Chemical name: 4-Hydroxyphenyl-alpha-D-glucopyranoside, CAS No 84380-01-8, EC No. 617-561-8), and
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'beta-arbutin' (Chemical name: 4-Hydroxyphenyl-β-D-glucopyranoside, CAS No 497-76-7, EC No. 207-850-3)
Requirements to Submit the Data
The Commission asks to submit, in particular, data regarding all physicochemical properties, toxicokinetics and toxicological end-points, assessment of exposure through consumer products and/or an indication on the suggested safe concentration limits for these ingredients.
More specifically, the points of highest importance are:
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Stability of alpha and beta arbutin as such, and in final formulations
a) Temperature, light and storage conditions, with a particular focus on pH
b) Amount of hydroquinone (HQ) as a contaminant in the cosmetic formulation when used, and not only under storage conditions
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Dermal absorption of alpha and beta arbutin
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Release rate of HQ: In particular, the biotransformation rate of alpha and beta arbutin to HQ in vivo; taking enzymatic activity of human skin and bacterial enzymes into consideration
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Data (if available) on aggregate exposure for cosmetic products that contain alpha and/or beta arbutin in face creams and body lotions
Source: European Commission