Flavouring Group Evaluation 217 Revision 3 (FGE.217Rev3): consideration of genotoxic potential for α,ß-unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones.

ABSTRACT

The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of four flavouring substances [FL-no 10.023, 10.030, 10.057 and 13.012] from subgroup 4.1 of FGE.19. For three of these substances [FL-no 10.023, 10.030 and 13.012], the concern for genotoxicity has been ruled out in previous revisions of Flavouring Group Evaluation 217 (FGE.217). However, in FGE.217Rev2, a concern for genotoxicity could not be ruled out for 3a,4,5,7a-tetrahydro-3,6-dimethylbenzofuran-2(3H)-one [FL-no 10.057]. After publication of FGE.217Rev2, industry provided additional genotoxicity studies for [FL-no 10.057], which are evaluated in the present opinion FGE.217Rev3. The flavouring substance [FL-no 10.057] did not induce gene mutations or numerical or structural chromosomal aberrations in vitro. Based on these data, the Panel concluded that the concern for genotoxicity is ruled out for [FL-no 10.057]. Consequently, it can be evaluated through the Procedure.