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

Abstract

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.

How Fermentation Affects the Antioxidant Properties of Cereals and Legumes

“…Today, almost all processed foods contain synthetic antioxidants and, despite being reported safe in the past, several studies have addressed their danger for human health, among which liver, kidney, and lungs damages, mutagenesis, carcinogenesis, and many others [19]. For this reason, between 2011 and 2012, the European food safety authority re-evaluated their maximum levels of intake in adults and children [24,25]. Considering the increasing risk factors related to synthetic antioxidants, there has been a global trend toward the use and the search for effective natural substance as therapeutic antioxidants.…”

An Overview of Natural Extracts with Antioxidant Activity for the Improvement of the Oxidative Stability and Shelf Life of Edible Oils

“…Butylated hydroxytoluene (BHT) and butylated hydroxyanisole (BHA), but also tertiary butylhydroquinone (TBHQ), and propyl gallate are common examples of the synthetic antioxidants used in the vegetable oil industry to retard oxidation reactions [3]. Since some harmful effects for synthetic antioxidants have been reported [4,5], international regulatory authorities have established limits to the amounts of synthetic antioxidants permitted in foods [6]. During the past decade, around the world, the preference of consumers for natural substitutes of synthetic additives is increasing [5,6], mainly for ideational/emotional reasons [7].…”

Single and Repeated Oral Dose Toxicity and Genotoxicity of the Leaves of Butterbur

“…Based on the results of this study, the no observed adverse effect level (NOAEL) of KP-1 was considered to be less than 1250 mg/kg/day in males and to be 1250 mg/kg/day in female rats after repeated oral administration for thirteen weeks under the conditions of this study. However, these values were not considered to be of toxicological significance when extrapolating the NOAEL to humans because a limiting ridge in the stomach is an organ that exists only in rats [35][36][37]. Consequently, the NOAEL was considered to be 5000 mg/kg/day except for changes in the limiting ridge.…”