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

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...

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Main Authors: EFSA Panel on Food Additives and Flavourings (FAF), Maged Younes, Gabriele Aquilina, Laurence Castle, Gisela Degen, Karl‐Heinz Engel, Paul J Fowler, Maria José Frutos Fernandez, Peter Fürst, Ursula Gundert‐Remy, Rainer Gürtler, Trine Husøy, Melania Manco, Peter Moldeus, Sabina Passamonti, Romina Shah, Ine Waalkens‐Berendsen, Matthew Wright, Romualdo Benigni, Claudia Bolognesi, Kevin Chipman, Eugenia Cordelli, Maria Carfì, Wim Mennes
Format: Article
Language:English
Published: Wiley 2023-04-01
Series:EFSA Journal
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Online Access:https://doi.org/10.2903/j.efsa.2023.7967
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author EFSA Panel on Food Additives and Flavourings (FAF)
Maged Younes
Gabriele Aquilina
Laurence Castle
Gisela Degen
Karl‐Heinz Engel
Paul J Fowler
Maria José Frutos Fernandez
Peter Fürst
Ursula Gundert‐Remy
Rainer Gürtler
Trine Husøy
Melania Manco
Peter Moldeus
Sabina Passamonti
Romina Shah
Ine Waalkens‐Berendsen
Matthew Wright
Romualdo Benigni
Claudia Bolognesi
Kevin Chipman
Eugenia Cordelli
Maria Carfì
Wim Mennes
author_facet EFSA Panel on Food Additives and Flavourings (FAF)
Maged Younes
Gabriele Aquilina
Laurence Castle
Gisela Degen
Karl‐Heinz Engel
Paul J Fowler
Maria José Frutos Fernandez
Peter Fürst
Ursula Gundert‐Remy
Rainer Gürtler
Trine Husøy
Melania Manco
Peter Moldeus
Sabina Passamonti
Romina Shah
Ine Waalkens‐Berendsen
Matthew Wright
Romualdo Benigni
Claudia Bolognesi
Kevin Chipman
Eugenia Cordelli
Maria Carfì
Wim Mennes
author_sort EFSA Panel on Food Additives and Flavourings (FAF)
collection DOAJ
description 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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spelling doaj-art-c2cfff8cfabd47ed9b8fbc8b7e05aaa12025-08-20T03:18:46ZengWileyEFSA Journal1831-47322023-04-01214n/an/a10.2903/j.efsa.2023.7967Flavouring 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: lactonesEFSA Panel on Food Additives and Flavourings (FAF)Maged YounesGabriele AquilinaLaurence CastleGisela DegenKarl‐Heinz EngelPaul J FowlerMaria José Frutos FernandezPeter FürstUrsula Gundert‐RemyRainer GürtlerTrine HusøyMelania MancoPeter MoldeusSabina PassamontiRomina ShahIne Waalkens‐BerendsenMatthew WrightRomualdo BenigniClaudia BolognesiKevin ChipmanEugenia CordelliMaria CarfìWim MennesAbstract 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.https://doi.org/10.2903/j.efsa.2023.7967FGE.217α,β‐unsaturated ketoneslactonesflavouring substancessubgroup 4.1FGE.19
spellingShingle EFSA Panel on Food Additives and Flavourings (FAF)
Maged Younes
Gabriele Aquilina
Laurence Castle
Gisela Degen
Karl‐Heinz Engel
Paul J Fowler
Maria José Frutos Fernandez
Peter Fürst
Ursula Gundert‐Remy
Rainer Gürtler
Trine Husøy
Melania Manco
Peter Moldeus
Sabina Passamonti
Romina Shah
Ine Waalkens‐Berendsen
Matthew Wright
Romualdo Benigni
Claudia Bolognesi
Kevin Chipman
Eugenia Cordelli
Maria Carfì
Wim Mennes
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
EFSA Journal
FGE.217
α,β‐unsaturated ketones
lactones
flavouring substances
subgroup 4.1
FGE.19
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic FGE.217
α,β‐unsaturated ketones
lactones
flavouring substances
subgroup 4.1
FGE.19
url https://doi.org/10.2903/j.efsa.2023.7967
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