Regulatory History: Butylated Hydroxyanisole
Tracking global safety evaluations, classification changes, and regional status updates for E320.
Factual Regulatory Reference
This database provides factual regulatory information compiled from official government sources. It does not constitute medical, nutritional, or safety advice. Regulatory status varies by country and is subject to change. Always refer to your local regulatory authority for the most current information.
Comprehensive Timeline
FDA approved BHA (butylated hydroxyanisole) as antioxidant for food preservation.
Japanese studies found BHA caused tumors in forestomach of rats at high doses, raising safety concerns.
IARC classified BHA as 'possibly carcinogenic to humans' (Group 2B) based on animal studies.
JECFA concluded forestomach tumors in rats are not relevant to humans (humans lack forestomach). Maintained ADI of 0-0.5 mg/kg bw/day.
FDA reviewed BHA safety following IARC classification, concluded available evidence supports continued safe use within regulated limits.
EFSA re-evaluated BHA (E320), concluded ADI of 0.5 mg/kg bw/day is protective and BHA is safe at current use levels.
California added BHA to Proposition 65 list of chemicals known to cause cancer, requiring warning labels on products sold in California.