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
2012
<p>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 <em>in vitro</em> micronucleus assay, so, 4,5-epoxydec-2(trans)-enal is considered an <em>in vitro</em> genotoxic agent. The negative results obtained in an <em>in vivo </em>micronucleus assay cannot overrule the positive results of the <em>in vitro </em>micronucleus assaywith and without S9-mix due to the lack of cytotoxicity in the bone marrow. On this basis, an <em>in vivo </em>Comet assay in rodents is recommended in order to verify possible genotoxic effects at the first site of contact (e.g., stomach/duodenum cells).</p>
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