Alpha-arbutin is a cosmetic ingredient that is not regulated under Cosmetic Regulation No 1223/2009, and is used as antioxidant, for skin bleaching and skin conditioning, and the structurally related compound beta-arbutin is also used as a depigmentating agent in cosmetic products.

The safety of beta-arbutin has been assessed previously and the SCCS says its effect seems to be due to the fact that it hydrolyses to Hydroquinone, which is listed in Annex II/1339 of the Regulation and is banned as a cosmetic ingredient with the exception of entry 14 in Annex III.

Its permitted use is restricted to professional use in artificial nail systems in a concentration in the final product up to 0.02%.

Since Hydroquinone could not be used as a skin whitener after introduction of a ban, other substances have been used for that purpose, including alpha-arbutin and beta-arbutin.

In the latest Opinion on alpha-arbutin​ the SCCS states that the use of the ingredient is “safe for consumers in cosmetic products in a concentration up to 2% in face creams and up to 0.5 % in body lotions.”​

A potential combined use of alpha-arbutin and other hydroquinone releasing substances in cosmetic products was not evaluated in this Opinion.

Basis of Opinion​

The present Opinion is based on information provided with the first submission of January 2011 and an Addendum submitted in December 2012 by the applicant, DSM.

In response to an informal request from DG SANCO last year, DSM confirmed that additional information on alpha-arbutin, to augment that submitted in its two previous dossiers of 2011 and 2012 is not available, in particular with regard to clinical testing or repeated toxicity tests in animals.

In light of similarities in metabolism of alpha- and beta-arbutin (with limited release of hydroquinone in skin compartments), the ingredients supplier suggests a read across/combined consideration of results from toxicity tests for both forms for an assessment of systemic hazards.

DSM further notes “that topical cosmetics considered likely to contain alpha-Arbutin would not produce systemic exposures above 400 µg alpha-Arbutin/person/day. This is well below the TTC Cramer class I threshold.”​

Yet, according to the terms of reference, the SCCS said it had to consider not only exposure resulting from the application of 2% alpha-arbutin creams to the face, neck and hands, but also a scenario where body lotions containing 0.5% alpha-arbutin are applied (also included in the first submission).