Safety of alpha-arbutin and beta-arbutin in cosmetic products

2022-03-25

Details

Publication date

25 March 2022

Author

Scientific Committee on Consumer Safety (SCCS)

Description

SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers (Rapporteur), Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven

SCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz

Contact:SANTE-C2-SCCS@ec.europa.eu

On request from: European Commission

SCCS Number: SCCS/1642/22

Adopted on: 15-16 March 2022

Conclusion of the opinion:

(1) In light of the data provided, does the SCCS consider α-arbutin safe when used in face creams up to a maximum concentration of 2% and in body lotions up to a maximum concentration of 0.5 %?

Having considered the data provided, and other relevant information available in scientific literature, the SCCS cannot conclude on the safety of alpha-arbutin when used in face creams up to a maximum concentration of 2% and in body lotions up to a maximum concentration of 0.5%. Relevant data on the degradation/metabolism of alpha-arbutin, exposed to the skin microbiome/enzymes, are not available and the release of hydroquinone and its final fate are not documented. These data are essentially required for safety assessment.

(2) In the event that the estimated exposure to α-arbutin from cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits.

For the reasons given under question 1, the SCCS cannot recommend a safe concentration of alpha-arbutin.

(3) In light of the data provided, does the SCCS consider β-arbutin safe when used in face creams up to a maximum concentration of 7%?

No information was provided during the call for data. The SCCS has, therefore, considered the information available in scientific literature but regarded it insufficient to conclude on the safety of beta-arbutin when used in face cream up to a maximum concentration of 7%. Also, relevant data on the fate of beta-arbutin, when applied to human skin and its microbiome/enzymes, are not available and the release of hydroquinone and its final fate are not documented.

(4) In the event that the estimated exposure to β-arbutin from cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits.

For the reasons given under question 3, the SCCS cannot recommend a safe concentration of beta-arbutin.

(5) In light of the data provided, does the SCCS consider that the presence of hydroquinone in the cosmetic formulations must remain below 1 ppm for both α- and β arbutin containing products?

Hydroquinone 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. In the new studies, submitted by the applicant, 3ppm was the LOQ/LOD of the methodology used.

(6) Does the SCCS have any further scientific concerns regarding the use of a- and β arbutin in cosmetic products in relation to aggregate exposure from such substances in cosmetics?

Safe concentrations for either of the arbutins in cosmetic products cannot be established without the data on the release of hydroquinone and their final fate.

Read More

European Commission, 25-03-22
; https://ec.europa.eu/health/publications/safety-alpha-arbutin-and-beta-arbutin-cosmetic-products_en