Regulatory Status
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Safety Data
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Expert Verdict
EU 2024/996 Annex III restricted: alpha-arbutin 2% face creams, 0.5% body lotions. 10x more potent tyrosinase inhibitor than beta. SCCS/1550/15 (2015). HQ release mechanism same as beta (enzymatic, acid, UV). HQ contamination must be <1 ppm. Transition: Feb 2025 placement, Nov 2025 withdrawal. UK has NOT adopted 2024/996. Oral LD50 300-500 mg/kg neat. Japan/Korea approved whitening active. Claims: brightening OK, whitening = quasi-drug/functional in Asia, bleaching prohibited globally.
Regulatory Flags
Frequently Asked Questions
Is Arbutin (Alpha-Arbutin and Beta-Arbutin) safe in cosmetics?
EU 2024/996 Annex III restricted: alpha-arbutin 2% face creams, 0.5% body lotions. 10x more potent tyrosinase inhibitor than beta. SCCS/1550/15 (2015). HQ release mechanism same as beta (enzymatic, acid, UV). HQ contamination must be <1 ppm. Transition: Feb 2025 placement, Nov 2025 withdrawal. UK has NOT adopted 2024/996. Oral LD50 300-500 mg/kg neat. Japan/Korea approved whitening active. Claims: brightening OK, whitening = quasi-drug/functional in Asia, bleaching prohibited globally. The EU classifies Arbutin (Alpha-Arbutin and Beta-Arbutin) as "restricted". Safety rating: GOOD.
Is Arbutin (Alpha-Arbutin and Beta-Arbutin) allowed in the EU?
Arbutin (Alpha-Arbutin and Beta-Arbutin) EU regulatory status: restricted. Maximum allowed concentration: 2% face / 0.5% body. This is based on EU Regulation 1223/2009 and its amendments.
What does Arbutin (Alpha-Arbutin and Beta-Arbutin) do in cosmetics?
Arbutin (Alpha-Arbutin and Beta-Arbutin) functions as: Skin Brightening. It is classified as a Cosmetic Ingredient in our database. CAS number: 497-76-7.
What is the Margin of Safety for Arbutin (Alpha-Arbutin and Beta-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
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Related Ingredients
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