Good Active Ingredient

Beta-Arbutin

INCI: BETA-ARBUTIN

CAS Number
497-76-7
Function
Skin lightening agent; tyrosinase inhibitor
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status restricted
EU Max Conc. 7%
🇺🇸 US Status permitted
US Notes Beta-Arbutin is not restricted by the FDA and may be used freely in cosmetic products without concentration limit. Not classified as an OTC drug active ingredient. No completed CIR monograph exists specifically for beta-arbutin. Widely sold OTC in skin brightening products. No federal hydroquinone impurity limits imposed on arbutin-containing cosmetics in the US.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

SCCS NOAEL Values

NOAEL/LOAEL values cited in official SCCS opinions for Beta-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)

Expert Verdict

EU restricted to 7% in face creams under Annex III (Regulation EU 2024/996, entry 378) with hydroquinone impurity limits; safe per SCCS/1642/22. US permitted without concentration limits. Residual concern from potential hydroquinone release via microbial hydrolysis.

⚠️
Concern Level: Moderate

Regulatory Flags

eu-annex-iii-restricted hydroquinone-precursor hydroquinone-impurity-limit face-cream-only-eu skin-lightening sccs-reviewed-2023 microbiome-conversion-risk

Frequently Asked Questions

Is Beta-Arbutin safe in cosmetics?

EU restricted to 7% in face creams under Annex III (Regulation EU 2024/996, entry 378) with hydroquinone impurity limits; safe per SCCS/1642/22. US permitted without concentration limits. Residual concern from potential hydroquinone release via microbial hydrolysis. The EU classifies Beta-Arbutin as "restricted". Safety rating: GOOD.

Is Beta-Arbutin allowed in the EU?

Beta-Arbutin EU regulatory status: restricted. Maximum allowed concentration: 7%. This is based on EU Regulation 1223/2009 and its amendments.

What does Beta-Arbutin do in cosmetics?

Beta-Arbutin functions as: Skin lightening agent; tyrosinase inhibitor. It is classified as a Active Ingredient in our database. CAS number: 497-76-7.

What is the Margin of Safety for 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

Check Beta-Arbutin compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
Check compliance across 55 jurisdictions
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
 ⚗️
Heavy Metal Limits
Compare limits across jurisdictions

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