EFSA Recommends Higher ADI for BHA

PARMA, ItalyFollowing a request from the European Commission, the European Food Safety Authority (EFSA), the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) issued a scientific opinion re-evaluating the safety of butylated hydroxyanisole (BHA) when used as food additive. The Panel established an acceptable daily intake (ADI) of 1.0 mg/kg bw/day.

BHA is a synthetic antioxidant authorized as a food additive in the European Union 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 acceptable daily intake (ADI) of 0.5 mg/kg bw/day with the ADI of the SCF being a temporary ADI.

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 of 0.5 mg/kg bw/day. The Panel established an ADI of 1.0 mg/kg bw/day; however, it concluded that at the current levels of use refined intake estimates are generally below the ADI of 1.0 mg/kg bw/day.

In food applications, BHA generally is used to keep fats from becoming rancid. It is also used as a yeast de-foaming agent. BHA 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.