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

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-SCCSec [dot] europa [dot] eu (SANTE-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1642/22
Adopted on: 31 January 2023

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 %?

The SCCS is of the opinion that alpha-arbutin used in face creams up to a maximum concentration of 2% and in body lotions up to a concentration of 0.5% is safe, also when used together.

(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.

Not applicable.

(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%?

The SCCS is of the opinion that beta-arbutin used in face creams up to a maximum concentration of 7% is safe.

(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.

Not applicable.

(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 for hydroquinone and 1ppm for the LOD.

(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?

Aggregate exposure of alpha-arbutin (2% in face cream and 0.5% in body lotion) with beta-arbutin (7% in face cream) are considered safe.

Keywords:

SCCS, scientific opinion, alpha-arbutin, beta-arbutin, Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of alpha- (CAS No. 84380-018, EC No. 617-561-8) and beta-arbutin (CAS No. 497-76-7, EC No. 207-8503) in cosmetic products, preliminary version of 15-16 March 2022, final version of 31 January 2023, SCCS/1642/22