Disclaimer: 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 may change. Always refer to your local regulatory authority for the most current information.
Regulatory History: Butylated Hydroxyanisole
E320 — Complete timeline of regulatory events
About This Timeline
This page documents the regulatory history of Butylated Hydroxyanisole (E320), including approvals, bans, safety evaluations, and classification changes by regulatory agencies worldwide.
Data source: Official regulatory documents, scientific publications, and agency announcements. All events are documented with source agencies and dates.
Complete Timeline
7 eventsFDA 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.
Important Notes
- This timeline is for informational purposes only and does not constitute safety advice.
- Regulatory decisions reflect the state of scientific knowledge at the time they were made.
- Current regulations may differ from historical events shown. Always consult official sources for up-to-date information.
- An approval in one country does not imply approval in others. Regulatory standards vary by jurisdiction.