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  • Title: Flavouring Group Evaluation 217 Revision 3 (FGE.217Rev3): consideration of genotoxic potential for α,β-unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones.
    Author: EFSA Panel on Food Additives and Flavourings (FAF), Younes M, Aquilina G, Castle L, Degen G, Engel KH, Fowler PJ, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Manco M, Moldeus P, Passamonti S, Shah R, Waalkens-Berendsen I, Wright M, Benigni R, Bolognesi C, Chipman K, Cordelli E, Carfì M, Mennes W.
    Journal: EFSA J; 2023 Apr; 21(4):e07967. PubMed ID: 37089172.
    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.
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