Scientific Opinion on the re-evaluation of butylated hydroxyanisole – BHA (E 320) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food (ANS) delivers a scientific opinion re-evaluating the safety of butylated hydroxyanisole (BHA) (E 320). BHA is a synthetic antioxidant authorised as a food additive in the EU that was previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) several times, the latest in 1989 and the EU Scientific Committee for Food (SCF) in 1989. Both committees established an ADI of 0.5 mg/kg bw/day, with that of the SCF being classified as temporary. Both ADIs were based on proliferative changes in the rat forestomach. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that became available since then and the data available following an EFSA public call for data. The Panel concluded that BHA does not raise concern with respect to genotoxicity. A large number of long-term toxicity and carcinogenicity studies with BHA have been performed, demonstrating proliferative changes in the forestomach with BMDL₁₀ values in the rat of 115 and 83 mg/kg bw/day. The Panel concluded that the present database does give reason to revise the ADI. The Panel considered that forestomach hyperplasia in rodents may no longer be relevant for human risk assessment. Based on a NOAEL of 100 mg/kg bw/day for growth retardation, increased mortality and behavioural effects in rat pups at higher dose levels, and using an uncertainty factor of 100 the Panel established an ADI of 1.0 mg/kg bw/day. This NOAEL also covers the BMDL10 values for forestomach hyperplasia observed in the rat. The Panel also concluded that at the current levels of use refined intake estimates are generally below the ADI of 1.0 mg/kg bw/day.