BHA is a synthetic antioxidant generally used to keep fats from becoming rancid. It is also used as a yeast de-foaming agent. The preservative is found in butter, meats, cereals, chewing gum, baked goods, snack foods, dehydrated potatoes, and beer. It is also found in animal feed, food packaging, cosmetics, rubber products, and petroleum products.
Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) of the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the re-evaluation of BHA as a food additive.
The preservative is authorised as a food additive in the EU. It 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 for BHA, but that of the SCF was deemed temporary.
The ANS Panel said it based its evaluation on previous evaluations, additional literature that became available since then and the information provided to it following an EFSA public call for data.
While the ANS concluded that BHA does not raise concern with respect to genotoxicity, it said that 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 argues that the present database does give reason to revise the ADI, and it commented 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.