Publication of the SCCS preliminary opinion on alpha-arbutin and beta-arbutin

Alpha-arbutin and beta-arbutin (INCI: ALPHA-ARBUTIN and ARBUTIN) are two substances of interest for their lightening action via a reduction in melanogenesis, by inhibiting tyrosinase. They are found as synthetic ingredients or in plant extracts. In March 2022, the SCCS issued its new preliminary opinion on their safety in cosmetic products, after the first conclusions in 2015 calling for clarification of certain elements. Indeed, these two substances can generate hydroquinone (INCI: HYDROQUINONE). This has, of course, long been a reference molecule for lightening products, it has however been banned due to the risks it causes, risk of depigmentation or even skin cancer (listed in Annex II of the Cosmetics Regulation and classified Carcinogenic Cat. 2 Mutagenic Cat. 2 by the CLP Regulation).

Source: epharmacognosy.com

The conditions and rates of hydroquinone formation from alpha and beta arbutin are unknown. It is possible that this toxic substance accumulates over time in the product, or upon contact with the skin after cutaneous metabolism (by the microbiota). Without details of this transformation, following the SCCS's request, the committee was unable to determine safe concentrations for use.

A safe residual hydroquinone content cannot be specified either.

Depigmenting or lightening agents containing hydroquinone cannot therefore be considered safe ingredients. Yet, there are many products containing them on the market. At the very least, a review of the safety report is strongly recommended.

Sources:

SCCS, Opinion on the safety of alpha-arbutin and betaarbutin in cosmetic products SCCS/1642/22 https://ec.europa.eu/health/publications/safety-alpha-arbutinand-beta-arbutin-cosmetic-products_en

SCCS, Opinion on α-arbutin, 27 May 2015, SCCS/1552/15.

SCCS, Opinion on β-arbutin, SCCS/1550/15, 25 March 2015.

European Parliament (2008). Regulation (EC) 1272/2008 of the European Parliament and of the Council. Official Journal of the European Union, L 353/1, 1355.

European Parliament. (2009). Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. In Official Journal of the European Union.

Bang SH, Han SJ, Kim DH. Hydrolysis of arbutin to hydroquinone by human skin bacteria and its effect on antioxidant activity. J Cosmet Dermatol. 2008 Sep;7(3):189-93. doi: 10.1111/j.1473-2165.2008.00387.x. PMID: 18789053.