Amyris Balsamifera Wood Oil

Permitted fragrance ingredient with a generally favorable safety profile at typical cosmetic use concentrations. Volatile oil distilled from the bark of Amyris balsamifera, composed predominantly of sesquiterpene alcohols. Not prohibited or restricted under EU Regulation 1223/2009 (CosIng ref. 74455). Registered under REACH (dossier 20940); ECHA classifies the substance as Skin Sensitizer 1B and Skin Irritant Category 2 based on human maximization test data — a weak sensitizer at low concentrations. High acute oral LD50 (4540 mg/kg rat) supports low systemic hazard. No formal CIR review; no FDA restriction. Main risks are fragrance sensitization and irritation, particularly in leave-on products at elevated concentrations. IFRA compliance and concentration control are the primary risk management tools.

Not reviewed by CIR panel; listed in FDA UNII system (UNII I1BJ961J2E); not prohibited or restricted by FDA for cosmetic use; FEMA GRAS status not established for this bark oil form; EPA TSCA registry: 8015-65-4