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

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],...

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Published in:EFSA journal 2023-04, Vol.21 (4), p.e07967-n/a
Main Authors: Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul J, Frutos Fernandez, Maria José, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Benigni, Romualdo, Bolognesi, Claudia, Chipman, Kevin, Cordelli, Eugenia, Carfì, Maria, Mennes, Wim
Format: Article
Language:English
Subjects:
Chromosome aberrations
FGE.19
FGE.217
Flavorings
flavouring substances
Food additives
Genotoxicity
Information retrieval
Ketones
Lactones
Revisions
Scientific Opinion
subgroup 4.1
Subgroups
α,β‐unsaturated ketones
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Summary: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.
ISSN:1831-4732
1831-4732
2314-9396
DOI:10.2903/j.efsa.2023.7967