Scientific Opinion on Flavouring Group Evaluation 226 (FGE.226): Consideration of genotoxicity data on one α,β-unsaturated aldehyde from chemical subgroup 1.1.1(b) of FGE.19 by EFSA
12 July 2012
The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority 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. The Flavour Industry has provided additional genotoxicity studies for the substance [FL-no: 16.071] in FGE.226. Based on these new data the Panel concluded 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 assaywith and without S9-mix due to the lack of cytotoxicity in the bone marrow. On this basis, an in vivo Comet assay in rodents is recommended in order to verify possible genotoxic effects at the first site of contact (e.g., stomach/duodenum cells).
© European Food Safety Authority, 2012
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