Permitted under conditionsAnx. IIIRef. III/377

ALPHA-ARBUTIN

ANTIOXIDANT · BLEACHING · SKIN CONDITIONING - MISCELLANEOUS

CAS
84380-01-8
EC
617-561-8
IUPAC
—
Max conc.
(a) 2 % (b) 0,5 %

Last CosIng update

4 April 2024

Description

Alpha-Arbutin is a hydroquinone glucoside, that is, a molecule derived from the union of a glucose unit and a phenolic ring of the hydroquinone type through a glycosidic bond of alpha configuration. In cosmetics it is assigned the technical functions of antioxidant, bleaching agent and miscellaneous skin conditioner.

Under Regulation (EC) No 1223/2009, Alpha-Arbutin appears in Annex III of restricted substances, under reference 377. The maximum authorized concentration is set differently according to product type: "(a) 2 %" for face creams and "(b) 0,5 %" for body lotions. The entry includes an additional literal condition: "Hydroquinone levels shall remain as low as possible in formulations containing alpha-Arbutin and shall not be higher than the unavoidable trace level." Two regulatory milestones are also set: "From 1 February 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market. From 1 November 2025 cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market." The substance is not classified as CMR and no additional mandatory labelling warnings are listed.

The information presented is for technical reference only and does not constitute a recommendation for use or an efficacy claim.

Detailed EU regulation

%

Maximum permitted concentration

(a) 2 % (b) 0,5 %

§

Regulatory framework

Regulation (EC) No 1223/2009 — Annex III, ref. 377

Last update reflected in the database: 4 April 2024

!

Conditions of use

Hydroquinone levels shall remain as low as possible in formulations containing alpha-Arbutin and shall not be higher than the unavoidable trace level. From 1 February 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market. From 1 November 2025 cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market.

Product type: (a) Face cream (b) Body lotion

Recent analyses mentioning this ingredient

  • InformativoOpinión científica SCCS (versión final) · 1 de febrero de 2023
    Safety of alpha-arbutin and beta-arbutin in cosmetic products

    La opinión final SCCS/1642/22, adoptada el 31 de enero de 2023, concluye que el alfa-arbutin es seguro hasta 2% en cremas faciales y hasta 0,5% en lociones corporales, incluso en uso conjunto, y que el beta-arbutin es seguro hasta 7% en cremas faciales. La exposición agregada de ambos arbutinos en esas concentraciones se considera segura. Respecto de la hidroquinona, el SCCS indica que debe mantenerse lo más baja posible y no superar las trazas inevitables presentes en ambos arbutinos, sin fijar un límite numérico de 1 ppm; en los nuevos estudios el LOQ fue de 3 ppm y el LOD de 1 ppm. La opinión responde a un mandato de la Comisión motivado por dudas sobre la liberación de hidroquinona y la exposición agregada.

Data source: Official CosIng from the European Commission, updated on 4 April 2024. Learn more →