The Panel on Food Additives and Nutrient Sources added to Food (ANS) delivers an opinion reevaluating the safety of butylated hydroxytoluene (BHT) (E 321). BHT is an authorised synthetic antioxidant that was previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the latest in 1996 and the EU Scientific Committee for Food (SCF) in 1987. The SCF established an ADI of 0-0.05 mg/kg bw/day based on thyroid, reproduction and haematological effects in the rat. JECFA allocated an ADI of 0-0.3 mg/kg bw/day for BHT based on effects in the reproduction segments and hepatic enzyme induction seen in two separate 2-generation studies in rats. The Panel concluded that BHT is not of concern with respect to genotoxicity and that any carcinogenicity would be thresholded. After the last SCF evaluation, two new 2-generation studies have been reported which were the basis for the ADI set by JECFA. Both studies revealed a NOAEL of 25 mg/kg bw/day. Overall, the Panel concluded that the present database gives reason to revise the ADI of 0.05 mg/kg bw/day. Based on the NOAEL of 25 mg/kg bw/day and an uncertainty factor of 100, the Panel derived an ADI of 0.25 mg/kg bw/day. Since the NOAEL of 25 mg/kg bw/day is below the BMDL10 value of 247 mg/kg bw/day derived from the data for the incidence of hepatocellular carcinomas in male rats, the Panel concluded that this NOAEL also covers the hepatocellular carcinomas observed in the long-term studies with BHT. Exposure of adults to BHT is unlikely to exceed the newly derived ADI at the mean and at the 95th percentile. For exposure of children to BHT from its use as food additive, the Panel noted that it is also unlikely that this ADI is exceeded at the mean, but is exceeded for some European countries (Finland, The Netherlands) at the 95th percentile.
SUMMARYFollowing a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the re-evaluation of butylated hydroxytoluene (BHT) (E 321) as a food additive.BHT (E 321) is a synthetic antioxidant authorised as a food additive in the EU that was previously evaluated by the EU Scientific Committee for Food (SCF) in 1987 and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) several times, the latest in 1996.The SCF established an ADI of 0-0.05 mg/kg bw/day based on thyroid, reproduction and haematological effects in the rat. At its last evaluation JECFA allocated an ADI of 0-0.3 mg/kg bw/day for BHT, based on effects in the reproduction segments and hepatic enzyme induction, seen in two separate 2-generation studies in rats. These studies were probably not available at the time of the SCF evaluation.Specifications have been defined in the EU legislation Directive 2008/48/EC and by JECFA (JECFA, 2006). The purity is specified to be not less than 99%.Absorption, distribution, metabolism and excretion of BHT have been studied in mice, rats, rabbits, chickens, monkeys and humans. Overall, these studies show that BHT is r...