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

Tabs

Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2016;14(1):4363 [26 pp.].
doi
10.2903/j.efsa.2016.4363
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.
Acknowledgements

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.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2013-00690
Adopted
9 December 2015
Published
12 January 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (663.96 KB)
Abstract

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.

Summary

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.

Keywords
tertiary-butyl hydroquinone, TBHQ, E 319, dietary exposure, EFSA Comprehensive European Food Consumption Database
Print on demand
Number of Pages
26