Bixa Orellana (Achiote) Seed Extract
INCI: BIXA ORELLANA SEED EXTRACT
CAS 89957-43-7
Skin conditioning, masking, antioxidant, natural colorant (bixin/norbixin)
Limited Data
Insufficient safety data available. Consider enriching this ingredient.
Details
Description
Skin conditioning, masking, antioxidant, natural colorant (bixin/norbixin)
Purpose
Function
Skin conditioning, masking, antioxidant, natural colorant (bixin/norbixin)
Profile
Properties
Silicone
Silicone free
Compliance
Regulatory Status
EU
Permitted
Safety
GOOD
US
Permitted
Absorptionlow
Sensitizationlow
MoSadequate
NOAEL76 mg/kg
ConcernLow
Flags
natural-colorantplant-derivedcarotenoidbixinnorbixinannattoantioxidantrare-sensitization-potentialfda-exempt-color-additiveeu-annex-iv-colorantcir-deferredeu_children_restricted
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.
US Note
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
Assessment
Ratings
Reference