Regulatory Status
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Safety Data
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Expert Verdict
Well-established natural colorant and skin conditioner with long history of safe cosmetic use. Permitted in EU (Annex IV, CI 75120) and FDA-exempt color additive in the US. Good tolerability confirmed in animal and human studies. Rare sensitization potential (bixin fraction); anaphylaxis documented via oral route but not established for topical cosmetic use. NOAEL robust at ≥1000 mg/kg/day. Overall safety profile is good for a plant-derived colorant at typical concentrations.
Regulatory Flags
Frequently Asked Questions
Is Bixa Orellana Seed Extract safe in cosmetics?
Well-established natural colorant and skin conditioner with long history of safe cosmetic use. Permitted in EU (Annex IV, CI 75120) and FDA-exempt color additive in the US. Good tolerability confirmed in animal and human studies. Rare sensitization potential (bixin fraction); anaphylaxis documented via oral route but not established for topical cosmetic use. NOAEL robust at ≥1000 mg/kg/day. Overall safety profile is good for a plant-derived colorant at typical concentrations. The EU classifies Bixa Orellana Seed Extract as "permitted". Safety rating: GOOD.
Is Bixa Orellana Seed Extract allowed in the EU?
Bixa Orellana Seed Extract EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Bixa Orellana Seed Extract do in cosmetics?
Bixa Orellana Seed Extract functions as: Skin conditioning, masking, antioxidant, natural colorant (bixin/norbixin). It is classified as a cosmetic ingredient in our database. CAS number: 89957-43-7.
What is the Margin of Safety for Bixa Orellana Seed Extract?
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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