SCCS’ final opinion on the safety of skin brightening agent arbutin

02 Feb 2023 --- The Scientific Committee on Consumer Safety (SCCS) has published its final opinion on the safety of alpha-arbutin and beta-arbutin in cosmetic products. The committee recommends that alpha-arbutin can safely be used in face creams up to a maximum concentration of 2% and in body lotions up to a concentration of 0.5%.

Beta-arbutin can be safely used in face creams up to a maximum concentration of 7%. Both alpha- and beta-arbutin can be used together at the recommended concentration.

The ingredients are currently not regulated under the European Commission’s (EC) Cosmetic Regulation.

The SCCS reports alpha- and beta-arbutin functions as antioxidants, skin bleaching and conditioning agents. The effects of arbutin on the skin could be attributed to their gradual hydrolysis and release of hydroquinone (HQ).

While the US Food and Drug Administration deems arbutin a safe alternative to HQ, it is banned for safety reasons in the EU due to the similarity in chemical structure to HQ.

HQ is listed in the EU Cosmetic Regulation as a prohibited cosmetic ingredient, with the exception of its use by professionals in artificial nail systems with a maximum concentration of up to 0.02% in the finished product.

“During previous discussions within the Working Group on Cosmetic Products, concerns have been raised on the HQ content, its release, as well as on the aggregate exposure from cosmetic products containing alpha-arbutin or beta-arbutin,” SCCS details.

“This led to additional consultation with the SCCS and resulted in the identification of a number of issues in the previous submissions. Notably, the stability and dermal absorption of [the ingredients], the release rate of HQ and the aggregate exposure calculation from cosmetics exposure.”Asia is revealed as the main market for alpha- and beta-arbutin.

SCCS review conclusion
The SCCS warns that HQ should remain as low as possible in formulations containing alpha-or beta-arbutin and should not be higher than the unavoidable traces in both arbutins.

It details that the HQ that could become available in the worst-case scenario from alpha-arbutin, is considered together with the amount present as impurity and the formation coming from alpha-arbutin by the action of the skin microbiome, is considered safe.

Aggregate exposure of alpha-arbutin with beta-arbutin, within recommended concentrations, is considered safe.

“Aggregate exposure of alpha- and beta-arbutin is considered safe. It should be noted that no new data was made available for beta-arbutin and the real interaction with the skin microbiome is unknown. Therefore, a worst-case scenario has been applied for the potential maximal release of HQ by beta-arbutin upon skin contact.”

“When the possibility of occurrence of ochronosis is considered, all exposures considered are safe.”

Cosmetic applications
The SCCS review of the available functions and uses of the naturally occurring compound beta-arbutin reveals that it is a derivative of HQ that can be found in the leaves and bark of many plants such as dry leaves of bearberry, cranberry, blueberry and wheat.

It has been proposed for use as a skin-lightening agent, inhibiting the production of the skin pigment melanin, which is formed through a series of oxidative reactions involving the amino acid tyrosine and the enzyme tyrosinase.

On the contrary, regarding alpha-arbutin, SCCS details that it is a synthetic substance. It is produced by enzymatic glycosylation of HQ in the presence of alpha-Amylase and dextrin.

Alpha-arbutin is used with laser therapy to treat refractory melasma and has been suggested as an alternative to beta-arbutin as a skin-lightening agent in topical preparations.

The Ordinary Alpha Arbutin 2% + HA is a water-based serum designed to target uneven skin tone and visibly improve pigmentation. Additionally, Skinceauticals Phyto+ is formulated in a soothing gel with botanical extracts cucumber and thyme combined with arbutin and kojic acid to improve the appearance of dark spots and promote an overall brighter, more even and radiant complexion.

“The main market of alpha-arbutin and beta-arbutin is Asia, with ten to fifteen times more new product launches containing either ingredient compared to the EU,” the SCCS final opinion document reveals.

By Radhika Sikaria

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