Bixa Orellana Extract

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.

FDA-exempt color additive (annatto extract); permitted in foods, drugs, and cosmetics including eye-area products per 21 CFR 73.30; CIR deferred evaluation as FDA has assessed safety