Scientific Opinion on Flavouring Group Evaluation 226 Revision 1 (FGE.226Rev1): consideration of genotoxicity data on one α,β-unsaturated aldehyde from chemical subgroup 1.1.1(b) of FGE.19


4,5-epoxydec-2(trans)-enal, subgroup 1.1.1(b), FGE.19, FGE.226
First published in the EFSA Journal
31 May 2017
4 May 2017
Last Updated
3 July 2017. This version replaces the previous one/s.
Scientific Opinion

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate the genotoxic potential of one flavouring substance from subgroup 1.1.1(b) of FGE.19 in the Flavouring Group Evaluation 226 (FGE.226). The flavour industry provided genotoxicity studies for the substance 4,5-epoxydec-2(trans)-enal [FL-no: 16.071]. Based on these data, the Panel concluded in FGE.226 that 4,5-epoxydec-2(trans)-enal did not induce gene mutations in bacterial cells but was positive in an in vitro micronucleus assay, so, 4,5-epoxydec-2(trans)-enal is considered an in vitro genotoxic agent. The negative results obtained in an in vivo micronucleus assay cannot overrule the positive results of the in vitro micronucleus assay with and without S9-mix due to the lack of demonstration of bone marrow exposure. Following this, the flavour industry has provided plasma analysis of a satellite group of rats treated with 4,5-epoxydec-2(trans)-enal in order to investigate the systemic exposure of animals in the in vivo micronucleus assay. However, the plasma analysis did not provide enough evidence of target tissue exposure. An in vivo Comet assay in rodents was recommended in FGE.226, in order to investigate possible genotoxic effects at the first site of contact (e.g. stomach/duodenum cells) and in the liver. An in vivo Comet assay in liver and duodenum was provided that suggests that 4,5-epoxydec-2(trans)-enal [FL-no: 16.071] did not induce DNA damage in the duodenum of rats. However, the genotoxic effect observed in vitro was confirmed in the in vivo Comet assay in the liver of rats. The Panel concluded that 4,5-epoxydec-2(trans)-enal [FL-no: 16.071] does raise a safety concern with respect to genotoxicity and, therefore, it cannot be evaluated according to the Procedure.

Panel members at the time of adoption
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle, Holger Zorn and Corina-Aurelia Zugravu.
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
fip [at]
EFSA Journal 2017;15(5):4847 [24 pp.].
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