Scientific Opinion on the re-evaluation of dodecyl gallate (E 312) as a food additive

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Article
Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2015;13(5):4086 [39 pp.].
doi
10.2903/j.efsa.2015.4086
Panel members at the time of adoption
Panel members: 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, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright, Maged Younes.
Acknowledgements

The Panel wishes to thank the members of the former Working Group “B” Food Additives and Nutrient Sources (2011–2014) and the members of the Standing Working Group on the re-evaluation of food additives other than gums and colours: Polly Ester Boon, Dimitrios Chrysafidis, Birgit Dusemund, David Gott, Rainer Gürtler, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Daniel Marzin, Peter Moldeus, Pasquale Mosesso, Dominique Parent-Massin, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen and Matthew Wright, for the preparatory work on this scientific opinion and EFSA staff members: Petra Gergelova and Ana Rincon for the support provided to this scientific opinion. EFSA acknowledges those European competent authorities, food industry and other stakeholders that provided occurrence data (usage and analytical data) on dodecyl gallate (E 312) in food and beverages, and supported the data collection for the Comprehensive European Food Consumption Database.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2011-00481
Adopted
14 April 2015
Published in the EFSA Journal
5 May 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

The EFSA ANS Panel was asked to deliver a scientific opinion re-evaluating dodecyl gallate (E 312) as a food additive. The Panel considered that whilst from theoretical considerations dodecyl gallate could be metabolised to dodecyl alcohol and gallic acid, there were insufficient data to demonstrate the rate and extent of dodecyl gallate metabolism in vivo. Having reviewed the data on the toxicokinetics (rate and extent of metabolism) of propyl, octyl and dodecyl gallate in a previous EFSA evaluation of propyl gallate, the Panel concluded that the available metabolism data on gallates were insufficient to provide a basis for the read-across of systemic toxicity data on propyl, octyl and dodecyl gallate to be valid. The Panel noted the absence of concern for genotoxicity and the lack of increase of tumours in the long-term study. However, owing to the lack of detailed reports on carcinogenicity and chronic toxicity studies with dodecyl gallate and the absence of a basis for read-across for systemic toxicity from propyl gallate data, the Panel could not reach a definitive conclusion on the presence or absence of a carcinogenic potential of dodecyl gallate. The Panel noted that there was no indication for overt toxicity in the available studies; however, owing to the limitations of these studies, the Panel was unable to identify any NOAEL. Overall, the available database was too limited to either establish an ADI or serve as a basis for a margin of safety approach to be applied with confidence. The Panel concluded that although there was unlikely to be a safety concern from the single use for which usage and analytical data were provided, an adequate assessment of the safety of dodecyl gallate as a food additive would require a sufficient toxicological database in line with its current guidance for submission for food additives evaluations.

Keywords
food additive, hydroxypropyl methyl cellulose, HPMC, E 464, propylene chlorohydrin, PCH, change in specificationsdodecyl gallate, n-dodecyl 3,4,5-trihydroxybenzoate, lauryl gallate, E 312, CAS No 1166-52-5, food additive, antioxidant
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Number of Pages
39