Regulatory Status
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Safety Data
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Expert Verdict
Berberine is a well-documented botanical alkaloid with strong antioxidant, anti-inflammatory, antimicrobial, and melanin-modulating activity. Favorable dermal safety profile confirmed in multiple topical studies. Key concern is inherent phototoxic/photosensitizing potential as a singlet oxygen generator; cosmetic use should avoid leave-on UV-exposed applications or require photostability testing. Suitable for rinse-off or UV-protected formulations at low concentrations.
Regulatory Flags
Frequently Asked Questions
Is Berberine safe in cosmetics?
Berberine is a well-documented botanical alkaloid with strong antioxidant, anti-inflammatory, antimicrobial, and melanin-modulating activity. Favorable dermal safety profile confirmed in multiple topical studies. Key concern is inherent phototoxic/photosensitizing potential as a singlet oxygen generator; cosmetic use should avoid leave-on UV-exposed applications or require photostability testing. Suitable for rinse-off or UV-protected formulations at low concentrations. The EU classifies Berberine as "permitted". Safety rating: GOOD.
Is Berberine allowed in the EU?
Berberine EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Berberine do in cosmetics?
Berberine functions as: Antioxidant, anti-inflammatory, antimicrobial, skin-conditioning, pigmentation-modulating agent. It is classified as a cosmetic ingredient in our database. CAS number: 2086-83-1.
What is the Margin of Safety for Berberine?
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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