Regulatory Status
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Safety Data
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SCCS NOAEL Values
NOAEL/LOAEL values cited in official SCCS opinions for Alpha-Arbutin.
| NOAEL | LOAEL | Route | Species | Study | DA% (SCCS) | Opinion |
|---|---|---|---|---|---|---|
| 200 mg/kg/day | - | Oral | Rat | Subchronic (90-day) (90 days) | 10 | SCCS/1642/22 (2023) |
Dermal Penetration Profile
Skin absorption and penetration characteristics of Alpha-Arbutin, relevant to systemic exposure and MoS calculations.
Source: J Dermatol Sci 2005
Expert Verdict
EU 2024/996 Annex III: 2% face, 0.5% body. 10x more potent tyrosinase inhibitor than beta-arbutin per SCCS/1550/15. HQ release via enzymatic/acid/UV hydrolysis with HQ contamination limit <1 ppm. UK has NOT adopted 2024/996. Japan and Korea approved as whitening active. Synthetic origin via enzymatic transglycosylation. Brightening permitted globally; whitening classified as functional cosmetic in Asia.
Regulatory Flags
Frequently Asked Questions
Is Alpha-Arbutin safe in cosmetics?
EU 2024/996 Annex III: 2% face, 0.5% body. 10x more potent tyrosinase inhibitor than beta-arbutin per SCCS/1550/15. HQ release via enzymatic/acid/UV hydrolysis with HQ contamination limit <1 ppm. UK has NOT adopted 2024/996. Japan and Korea approved as whitening active. Synthetic origin via enzymatic transglycosylation. Brightening permitted globally; whitening classified as functional cosmetic in Asia. The EU classifies Alpha-Arbutin as "restricted". Safety rating: GOOD.
Is Alpha-Arbutin allowed in the EU?
Alpha-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 Alpha-Arbutin do in cosmetics?
Alpha-Arbutin functions as: Tyrosinase inhibitor; synthetic alpha-enantiomer of arbutin; approximately 10x stronger tyrosinase inhibition than beta-arbutin at equivalent concentrations; reversible competitive inhibition at L-DOPA binding site. It is classified as a Active Ingredient in our database. CAS number: 84380-01-8.
What is the Margin of Safety for Alpha-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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