Following a request from the European Commission (EC), the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating the safety of tertiary-butyl hydroquinone (TBHQ) (E 319) when used as a food additive.
TBHQ (E 319) is authorised as a food additive in the European Union (EU) in accordance with Annex II and Annex III to Regulation (EC) No 1333/2008. For TBHQ (E 319), an acceptable daily intake (ADI) of 0.7 mg/kg body weight (bw) has been established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1998 and confirmed by the European Food Safety Authority (EFSA) in 2004.
In 2004, the EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) estimated adults’, children’s and infants’ potential exposure to TBHQ through the consumption of fat, under the assumption that all fats consumed contained TBHQ at the maximum proposed level of 200 mg/kg. The intake estimates suggested that exposure in adults and children did not exceed the ADI, however, if TBHQ was to be used in infant formulae, the exposure in infants could exceed the ADI.
The present statement provides a refined exposure assessment for TBHQ (E 319) based on individual food consumption data which became available within the EFSA Comprehensive European Food Consumption Database, newly submitted information on the actual usage levels and analytical data of TBHQ (E 319) in food, provided to EFSA by the food industry and Member States, following an EFSA call for data launched in March 2014.
Usage levels of TBHQ (E 319) reported by industry cover 5 out of the 19 authorised uses of TBHQ (E 319) as a food additive, whereas analytical data received from Member States cover 10 food categories.
The current exposure estimates for TBHQ (E 319) based on the maximum permitted level (MPL) scenario are in the same order of magnitude of those obtained by the EFSA ANS Panel in 2004: indeed if assuming the TBHQ is always present at levels equal to the MPL in all food categories in which its use is authorised, the 95th percentile in toddlers and children exceeds the ADI. However, based on the refined exposure assessment scenarios, the current estimates are lower for all population groups at both the mean and the 95th percentile, and do not exceed the ADI.
EFSA concluded that, using MPLs, exposure estimates for TBHQ (E 319) exceeded the ADI of 0.7 mg/kg bw per day at the high level for toddlers and children. In the refined exposure scenarios, the ADI was not exceeded in any of the population groups.