IngredientsEuropean Union
Alpha-arbutin in EU cosmetics: status and maximum concentration
INCI ALPHA-ARBUTIN · CAS 84380-01-8
EU status: Restrictedtwo product types only
Data from Certo’s regulatory database as of
Some rows corrected against the legal texts on
The short answer
Alpha-arbutin is restricted in cosmetic products sold in the European Union (two product types only). The binding limits are set in Regulation (EC) No 1223/2009, Annex III, entry 377.
EU legal requirements
| Product type or use | Limit | Conditions and label wording | Applies from |
|---|---|---|---|
| EU Cosmetics Regulation, Annex III 377 Legal text | |||
| Face creams | ≤ 2 % | — | 1 February 2025 (placing on the market); 1 November 2025 (making available, including existing stock) |
| Body lotions | ≤ 0.5 % | — | 1 February 2025 (placing on the market); 1 November 2025 (making available, including existing stock) |
| Any other product | Not allowed | — | 1 February 2025 (placing on the market); 1 November 2025 (making available, including existing stock) |
| Every product type | — | Hydroquinone levels must remain as low as possible in formulations containing alpha-arbutin and must not be higher than the unavoidable trace level. | 1 February 2025 (placing on the market); 1 November 2025 (making available, including existing stock) |
What the texts say
Reference number: 377 Chemical name/INN: 4-Hydroxyphenyl-alpha-D-glucopyranoside (44) Name of Common Ingredients Glossary: Alpha-Arbutin CAS number: 84380-01-8 EC number: 617-561-8 Product type, body parts: (a) Face cream (b) Body lotion Maximum concentration in ready for use preparation: (a) 2 % (b) 0,5 % Other: Hydroquinone levels shall remain as low as possible in formulations containing alpha-Arbutin and shall not be higher than the unavoidable trace level.
Not to be confused with
- Arbutin (Annex III 378): A different substance, allowed only in face creams up to 7 %.
- Deoxyarbutin, tetrahydropyranyloxy phenol (Annex II 1657): Banned in cosmetic products.
Sources
This page is general regulatory information, not legal advice. Rely on the legal texts linked above and on your own regulatory experts before making a compliance decision.