Alpha-arbutin is used as an antioxidant for skin bleaching and skin conditioning, the safety of which has come under question of late.
In response to industry concerns, DSM's regulatory experts submitted a safety dossier to the Scientific Committee on Consumer Safety which the company reckons has convinced the European Commission that the ingredient is safe.
The document included an evaluation of hydroquinone release, data on alpha-arbutin stabilization in formulated cosmetics, and test results explaining the behavior of alpha-arbutin on the skin.
'Skin tone - one of the biggest growing segments'
On looking into the matter, the SCCS has since ruled the ingredient safe at levels of up to 2% in face care products and up to 0.5% in body care products.
"Skin tone applications are one of the biggest growing segments in the skin care market, especially in the Asian markets. I’m extremely pleased with the positive SCCS Opinion as it allows the cosmetic industry to continue using this high-performing and easy-to-formulate active ingredient,” says Dr. Mathias Gempeler, Global Marketing Skin Care Head at DSM.
DSM introduced alpha-arbutin to the cosmetics industry more than 10 years ago. According to the company, the activity of the ingredient in promoting the appearance of an even skin tone has been shown in several clinical studies 1,2.
"At a 1% concentration level, the molecule outperformed other commonly-used cosmetic ingredients such as kojic acid and beta-arbutin."
Basis of the Opinion
The current SCCS Opinion is based on information provided with the first submission of January 2011 and an Addendum submitted in December 2012 by 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.