Permitted under conditionsAnx. IIIRef. III/378

ARBUTIN

ANTIOXIDANT · BLEACHING · SKIN CONDITIONING - MISCELLANEOUS

CAS
497-76-7
EC
207-850-3
IUPAC
—
Max conc.
7 %

Last CosIng update

4 April 2024

Description

Arbutin is a glucoside derived from hydroquinone. Its structure corresponds to an organic molecule in which a glucose unit is linked through a glucosidic bond to a hydroxylated aromatic ring. Within the cosmetic framework, it is assigned the technical functions of antioxidant, bleaching agent and miscellaneous skin conditioner. It is also identified under the name ARBUTIN.

Under Regulation (EC) No 1223/2009, this ingredient appears in Annex III, reference 378, corresponding to the list of substances subject to restrictions. The maximum authorized concentration is "7 %" and the permitted product type is "Face cream". Among the additional conditions established, it is stated verbatim: "Hydroquinone levels shall remain as low as possible in formulations containing alpha-Arbutin and shall not be higher than the unavoidable trace level." The regulatory text also includes the following transitional provisions: "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." No classification as a CMR substance is recorded, nor additional mandatory labelling warnings apart from the conditions cited.

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

7 %

§

Regulatory framework

Regulation (EC) No 1223/2009 — Annex III, ref. 378

Last update reflected in the database: 4 April 2024

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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: Face cream

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 →