Statement on the refined exposure assessment of tertiary-butyl hydroquinone (E 319)


Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2016;14(1):4363 [26 pp.].
Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Agneta Oskarsson, Dominique Parent-Massin, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes.
The Panel wishes to thank the EFSA staff members Francesca Romana Mancini, Davide Arcella, Stavroula Tasiopoulou and Alexandra Tard for the support provided to this scientific opinion. The ANS Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
9 December 2015
Published in the EFSA Journal
12 January 2016
European Food Safety Authority (EFSA), Parma, Italy
The current ANS Panel statement is a refined exposure assessment of tertiary-butyl hydroquinone (TBHQ, E 319) when used as a food additive. TBHQ (E 319) is authorised as a food additive in the EU with an acceptable daily intake (ADI) of 0.7 mg/kg body weight (bw), as established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1998 and confirmed by EFSA in 2004. In 2004, the EFSA Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) adopted an opinion on the safety in use of TBHQ (E 319) in fats and oils used for human consumption. In that opinion, the Panel concluded that the exposure in adults did not exceed the ADI, however, if TBHQ (E 319) was to be used in infant formulae, the exposure in infants could exceed the ADI. Following this conclusion, EFSA performed a refined exposure assessment for TBHQ (E 319) based on individual food consumption data available within the EFSA Comprehensive European Food Consumption Database, on newly submitted data on the actual usage levels of TBHQ (E 319) and analytical data provided by the food industry and Member States. EFSA ANS Panel concluded that, using the maximum permitted levels, exposure estimates exceed the ADI of 0.7 mg/kg bw per day at the high level for toddlers and children, however, in the refined exposure scenarios, the ADI was not exceeded in any of the population groups.
tertiary-butyl hydroquinone, TBHQ, E 319, dietary exposure, EFSA Comprehensive European Food Consumption Database
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