Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Expert Verdict
EU 2024/996 Annex III restricted: beta-arbutin 7% face creams only. SCCS/1642/22 (Jan 2023). Hydroquinone release is central safety concern (enzymatic, acid-catalyzed, UV-mediated). Hydroquinone is Annex II entry 1339 (prohibited) and must remain at unavoidable traces (3 ppm LOQ, 1 ppm LOD). Transition: Feb 2025 placement, Nov 2025 withdrawal. UK has not adopted 2024/996. Japan/Korea approved as quasi-drug/functional cosmetic whitening active. Claims: brightening acceptable; whitening and bleaching prohibited globally.
Regulatory Flags
Frequently Asked Questions
Is Arbutin safe in cosmetics?
EU 2024/996 Annex III restricted: beta-arbutin 7% face creams only. SCCS/1642/22 (Jan 2023). Hydroquinone release is central safety concern (enzymatic, acid-catalyzed, UV-mediated). Hydroquinone is Annex II entry 1339 (prohibited) and must remain at unavoidable traces (3 ppm LOQ, 1 ppm LOD). Transition: Feb 2025 placement, Nov 2025 withdrawal. UK has not adopted 2024/996. Japan/Korea approved as quasi-drug/functional cosmetic whitening active. Claims: brightening acceptable; whitening and bleaching prohibited globally. The EU classifies Arbutin as "restricted". Safety rating: GOOD.
Is Arbutin allowed in the EU?
Arbutin EU regulatory status: restricted. Maximum allowed concentration: 7% face creams only. This is based on EU Regulation 1223/2009 and its amendments.
What does Arbutin do in cosmetics?
Arbutin functions as: Tyrosinase inhibitor; competitive inhibitor at L-DOPA binding site; reversible inhibition of melanin synthesis; natural beta-D-glucopyranoside of hydroquinone found in bearberry (Arctostaphylos uva-ursi), wheat, and pear. It is classified as a Active Ingredient in our database. CAS number: 497-76-7.
What is the Margin of Safety for Arbutin?
adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.
Compliance Tools
Check Arbutin compliance across multiple jurisdictions:
Related Ingredients
Is Arbutin in Your Products?
Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.
Try Piro Free →Analyze Your Full Ingredient List
Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Arbutin in your formulation.