EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on Flavouring Group Evaluation 216, Revision 1 (FGE.216Rev1). Consideration of genotoxic potential for α,β-unsaturated 2-Phenyl -2-Alkenals from Subgroup 3.3 of FGE.19

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 five flavouring substances from subgroup 3.3 of FGE.19. In the Flavouring Group Evaluation 216 (FGE.216) additional genotoxicity data were requested. Additional genotoxicity studies have now been provided for the representative substance 2-phenylcrotonaldehyde [FL-no: 05.062]. Based on these new data the Panel concluded that the concern for genotoxicity could not be ruled out and requests a proof of sufficient systemic exposure of animals treated with 2-phenylcrotonaldehyde. Moreover, since the substance was genotoxic only without metabolic activation, it appears necessary to prove the absence of genotoxic effect locally in the gastro intestinal system using the Comet assay.