Statement on the safety assessment of the exposure to butylated hydroxyanisole E 320 (BHA) by applying a new exposure assessment methodology

Abstract The European Food Safety Authority have asked its Scientific Panel on Food Additives and Nutrient Sources added to Food to prepare a revised exposure assessment to BHA (E 320) in order to apply a new exposure assessment methodology with the use of the EFSA Comprehensive Food Consumption Database and to take into account the exposure from the use in food contact materials. The exposure to BHA from its use as food additive using maximum permitted levels at mean level was in the range of 0.04‐0.23 mg/kg bw/day for toddlers, 0.08‐0.36 mg/kg bw/day for children, 0.06‐0.18 mg/kg bw/day for adolescents, 0.03‐0.12 mg/kg bw/day for adults and 0.02‐0.11 mg/kg bw/day for the elderly. High level exposures at the 95 th percentile was estimated in the range of 0.14‐0.57 mg/kg bw/day for toddlers, 0.26‐0.60 mg/kg bw/day for children, 0.12‐0.38 mg/kg bw/day for adolescents, 0.08‐1.12 mg/kg bw/day for adults, and 0.05‐0.72 mg/kg bw/day for the elderly. Exposure to BHA from its use in food contact materials would be 0.43, 0.6, 1.3 and 2.5 mg/kg bw/day for adults and the elderly, adolescents, children and toddlers, respectively, assuming that consumers from all the population groups also consume 1 kg of food packed in plastics containing BHA at the maximum permitted quantity. The Panel concluded that exposure to BHA from its use as food additive based on new exposure estimates does not exceed the ADI of 1 mg/kg bw/day at the mean and generally does not exceed the ADI for adults at high level exposure (except for one country). The Panel also concluded that combined exposure to BHA from its use as food additive in foods and additive to food contact materials does exceed the ADI for most population groups on average and on high level consumption.