Scientific Opinion on Flavouring Group Evaluation 215 Revision 1 (FGE.215Rev1):  seven α,β-unsaturated cinnamyl ketones from subgroup 3.2 of FGE.19

Maged Younes; Gabriele Aquilina; Laurence Castle; Karl-Heinz Engel; Paul Fowler; Maria Jose Frutos Fernandez; Peter Fürst; Ursula Gundert-Remy; Rainer Gürtler; Trine Husøy; Peter Moldeus; Agneta Oskarsson; Romina Shah; Ine Waalkens-Berendsen; Detlef Wölfle; Romualdo Benigni; Claudia Bolognesi; Kevin Chipman; Eugenia Cordelli; Gisela Degen; Daniel Marzin; Camilla Svendsen; Maria Carfì; Wim Mennes; EFSA Panel on Food Additives and Flavourings (FAF)

doi:10.2903/j.efsa.2019.5875

Scientific Opinion on Flavouring Group Evaluation 215 Revision 1 (FGE.215Rev1): seven α,β-unsaturated cinnamyl ketones from subgroup 3.2 of FGE.19

Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Ursula Gundert-Remy, Rainer Gürtler, Trine Husøy, Peter Moldeus, Agneta Oskarsson, Romina Shah, Ine Waalkens-Berendsen, Detlef Wölfle, Romualdo Benigni, Claudia Bolognesi, Kevin Chipman, Eugenia Cordelli, Gisela DegenDaniel Marzin, Camilla Svendsen, Maria Carfì, Wim Mennes, EFSA Panel on Food Additives and Flavourings (FAF)

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Abstract

Abstract The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of flavouring substances from subgroup 3.2 of FGE.19 in the Flavouring Group Evaluation 215, Revision 1 (FGE.215Rev1). In FGE.215, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the concern for genotoxicity could not be ruled out and requested in vivo data for the two representative substances 4-phenylbut-3-en-2-one [FL-no: 07.024] and 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030]. The Flavour Industry has provided additional genotoxicity studies for both representative substances [FL-no: 07.024] and [FL-no: 07.030]. Based on these new data, the Panel concluded that the concern for genotoxicity is ruled out for the representative substance [FL-no: 07.024] and for the structurally related substances 4-phenylbut-3-en-2-ol [FL-no: 02.066] and 3-methyl-4-phenylbut-3-en-2-one [FL-no: 07.027] which can accordingly be evaluated through the Procedure in FGE.69. For the representative substance 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030], the Panel concluded that [FL-no: 07.030] is aneugenic in vitro. For such substances, there is currently no agreed follow-up strategy to finalise their safety assessment. The Panel is aware that the EFSA Scientific Committee is going to address this issue and a statement clarifying the assessment of in vitro aneugenic substances is under preparation. The Panel concluded therefore that, for the time being, the representative substance 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030] and the structurally related substances vanillylidene acetone [FL-no: 07.046] and 1-(4-methoxyphenyl)-4-methylpent-1-en-3-one [FL-no: 07.049] cannot be evaluated through the Procedure. The Panel further concluded that 4-(2,3,6-trimethylphenyl)but-3-en-2-one [FL-no: 07.206] is to be considered as a stand-alone substance due to the presence of the methyl groups, therefore, in vitro genotoxicity data were requested for [FL-no: 07.206]. Industry communicated that the evaluation of [FL-no: 07.206] is not supported any longer, therefore additional data were not submitted.

Original language	English
Pages	e05875
Number of pages	34
Volume	17
No.	11
Specialist publication	EFSA Journal
DOIs	https://doi.org/10.2903/j.efsa.2019.5875
Publication status	Published - Nov 2019

Bibliographical note

Acknowledgements: The FAF Panel wishes to thank the Working Group on Genotoxicity of the former EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) for the preparatory work on this scientific opinion, in particular Mona-Lise Binderup, Francesca Marcon and Pasquale Mosesso. The Panel wishes to thank the hearing experts: Vibe Beltoft and Karin Nørby and EFSA staff: Natalia Kovalkovi cova and Giorgia Vianello for the support provided to this scienti fic output

Keywords

FGE.215
α
β-unsaturated cinnamyl ketones
flavouring substances
safety evaluation
FGE.19
subgroup 3.2

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-No Derivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
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Cite this

Younes, M., Aquilina, G., Castle, L., Engel, K.-H., Fowler, P., Frutos Fernandez, M. J., Fürst, P., Gundert-Remy, U., Gürtler, R., Husøy, T., Moldeus, P., Oskarsson, A., Shah, R., Waalkens-Berendsen, I., Wölfle, D., Benigni, R., Bolognesi, C., Chipman, K., Cordelli, E., ... EFSA Panel on Food Additives and Flavourings (FAF) (2019). Scientific Opinion on Flavouring Group Evaluation 215 Revision 1 (FGE.215Rev1): seven α,β-unsaturated cinnamyl ketones from subgroup 3.2 of FGE.19. EFSA Journal, 17(11), e05875. https://doi.org/10.2903/j.efsa.2019.5875

Younes, M, Aquilina, G, Castle, L, Engel, K-H, Fowler, P, Frutos Fernandez, MJ, Fürst, P, Gundert-Remy, U, Gürtler, R, Husøy, T, Moldeus, P, Oskarsson, A, Shah, R, Waalkens-Berendsen, I, Wölfle, D, Benigni, R, Bolognesi, C, Chipman, K, Cordelli, E, Degen, G, Marzin, D, Svendsen, C, Carfì, M, Mennes, W & EFSA Panel on Food Additives and Flavourings (FAF) 2019, 'Scientific Opinion on Flavouring Group Evaluation 215 Revision 1 (FGE.215Rev1): seven α,β-unsaturated cinnamyl ketones from subgroup 3.2 of FGE.19' EFSA Journal, vol. 17, no. 11, pp. e05875. https://doi.org/10.2903/j.efsa.2019.5875

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title = "Scientific Opinion on Flavouring Group Evaluation 215 Revision 1 (FGE.215Rev1): seven α,β-unsaturated cinnamyl ketones from subgroup 3.2 of FGE.19",

abstract = "Abstract The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of flavouring substances from subgroup 3.2 of FGE.19 in the Flavouring Group Evaluation 215, Revision 1 (FGE.215Rev1). In FGE.215, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the concern for genotoxicity could not be ruled out and requested in vivo data for the two representative substances 4-phenylbut-3-en-2-one [FL-no: 07.024] and 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030]. The Flavour Industry has provided additional genotoxicity studies for both representative substances [FL-no: 07.024] and [FL-no: 07.030]. Based on these new data, the Panel concluded that the concern for genotoxicity is ruled out for the representative substance [FL-no: 07.024] and for the structurally related substances 4-phenylbut-3-en-2-ol [FL-no: 02.066] and 3-methyl-4-phenylbut-3-en-2-one [FL-no: 07.027] which can accordingly be evaluated through the Procedure in FGE.69. For the representative substance 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030], the Panel concluded that [FL-no: 07.030] is aneugenic in vitro. For such substances, there is currently no agreed follow-up strategy to finalise their safety assessment. The Panel is aware that the EFSA Scientific Committee is going to address this issue and a statement clarifying the assessment of in vitro aneugenic substances is under preparation. The Panel concluded therefore that, for the time being, the representative substance 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030] and the structurally related substances vanillylidene acetone [FL-no: 07.046] and 1-(4-methoxyphenyl)-4-methylpent-1-en-3-one [FL-no: 07.049] cannot be evaluated through the Procedure. The Panel further concluded that 4-(2,3,6-trimethylphenyl)but-3-en-2-one [FL-no: 07.206] is to be considered as a stand-alone substance due to the presence of the methyl groups, therefore, in vitro genotoxicity data were requested for [FL-no: 07.206]. Industry communicated that the evaluation of [FL-no: 07.206] is not supported any longer, therefore additional data were not submitted.",

keywords = "FGE.215, α, β-unsaturated cinnamyl ketones, flavouring substances, safety evaluation, FGE.19, subgroup 3.2",

author = "Maged Younes and Gabriele Aquilina and Laurence Castle and Karl-Heinz Engel and Paul Fowler and {Frutos Fernandez}, {Maria Jose} and Peter F{\"u}rst and Ursula Gundert-Remy and Rainer G{\"u}rtler and Trine Hus{\o}y and Peter Moldeus and Agneta Oskarsson and Romina Shah and Ine Waalkens-Berendsen and Detlef W{\"o}lfle and Romualdo Benigni and Claudia Bolognesi and Kevin Chipman and Eugenia Cordelli and Gisela Degen and Daniel Marzin and Camilla Svendsen and Maria Carf{\`i} and Wim Mennes and {EFSA Panel on Food Additives and Flavourings (FAF)}",

note = "Acknowledgements: The FAF Panel wishes to thank the Working Group on Genotoxicity of the former EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) for the preparatory work on this scientific opinion, in particular Mona-Lise Binderup, Francesca Marcon and Pasquale Mosesso. The Panel wishes to thank the hearing experts: Vibe Beltoft and Karin N{\o}rby and EFSA staff: Natalia Kovalkovi cova and Giorgia Vianello for the support provided to this scienti fic output",

year = "2019",

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doi = "10.2903/j.efsa.2019.5875",

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pages = "e05875",

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AU - Younes, Maged

AU - Aquilina, Gabriele

AU - Castle, Laurence

AU - Engel, Karl-Heinz

AU - Fowler, Paul

AU - Frutos Fernandez, Maria Jose

AU - Fürst, Peter

AU - Gundert-Remy, Ursula

AU - Gürtler, Rainer

AU - Husøy, Trine

AU - Moldeus, Peter

AU - Oskarsson, Agneta

AU - Shah, Romina

AU - Waalkens-Berendsen, Ine

AU - Wölfle, Detlef

AU - Benigni, Romualdo

AU - Bolognesi, Claudia

AU - Chipman, Kevin

AU - Cordelli, Eugenia

AU - Degen, Gisela

AU - Marzin, Daniel

AU - Svendsen, Camilla

AU - Carfì, Maria

AU - Mennes, Wim

AU - EFSA Panel on Food Additives and Flavourings (FAF)

N1 - Acknowledgements: The FAF Panel wishes to thank the Working Group on Genotoxicity of the former EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) for the preparatory work on this scientific opinion, in particular Mona-Lise Binderup, Francesca Marcon and Pasquale Mosesso. The Panel wishes to thank the hearing experts: Vibe Beltoft and Karin Nørby and EFSA staff: Natalia Kovalkovi cova and Giorgia Vianello for the support provided to this scienti fic output

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N2 - Abstract The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of flavouring substances from subgroup 3.2 of FGE.19 in the Flavouring Group Evaluation 215, Revision 1 (FGE.215Rev1). In FGE.215, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the concern for genotoxicity could not be ruled out and requested in vivo data for the two representative substances 4-phenylbut-3-en-2-one [FL-no: 07.024] and 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030]. The Flavour Industry has provided additional genotoxicity studies for both representative substances [FL-no: 07.024] and [FL-no: 07.030]. Based on these new data, the Panel concluded that the concern for genotoxicity is ruled out for the representative substance [FL-no: 07.024] and for the structurally related substances 4-phenylbut-3-en-2-ol [FL-no: 02.066] and 3-methyl-4-phenylbut-3-en-2-one [FL-no: 07.027] which can accordingly be evaluated through the Procedure in FGE.69. For the representative substance 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030], the Panel concluded that [FL-no: 07.030] is aneugenic in vitro. For such substances, there is currently no agreed follow-up strategy to finalise their safety assessment. The Panel is aware that the EFSA Scientific Committee is going to address this issue and a statement clarifying the assessment of in vitro aneugenic substances is under preparation. The Panel concluded therefore that, for the time being, the representative substance 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030] and the structurally related substances vanillylidene acetone [FL-no: 07.046] and 1-(4-methoxyphenyl)-4-methylpent-1-en-3-one [FL-no: 07.049] cannot be evaluated through the Procedure. The Panel further concluded that 4-(2,3,6-trimethylphenyl)but-3-en-2-one [FL-no: 07.206] is to be considered as a stand-alone substance due to the presence of the methyl groups, therefore, in vitro genotoxicity data were requested for [FL-no: 07.206]. Industry communicated that the evaluation of [FL-no: 07.206] is not supported any longer, therefore additional data were not submitted.

AB - Abstract The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of flavouring substances from subgroup 3.2 of FGE.19 in the Flavouring Group Evaluation 215, Revision 1 (FGE.215Rev1). In FGE.215, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the concern for genotoxicity could not be ruled out and requested in vivo data for the two representative substances 4-phenylbut-3-en-2-one [FL-no: 07.024] and 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030]. The Flavour Industry has provided additional genotoxicity studies for both representative substances [FL-no: 07.024] and [FL-no: 07.030]. Based on these new data, the Panel concluded that the concern for genotoxicity is ruled out for the representative substance [FL-no: 07.024] and for the structurally related substances 4-phenylbut-3-en-2-ol [FL-no: 02.066] and 3-methyl-4-phenylbut-3-en-2-one [FL-no: 07.027] which can accordingly be evaluated through the Procedure in FGE.69. For the representative substance 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030], the Panel concluded that [FL-no: 07.030] is aneugenic in vitro. For such substances, there is currently no agreed follow-up strategy to finalise their safety assessment. The Panel is aware that the EFSA Scientific Committee is going to address this issue and a statement clarifying the assessment of in vitro aneugenic substances is under preparation. The Panel concluded therefore that, for the time being, the representative substance 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030] and the structurally related substances vanillylidene acetone [FL-no: 07.046] and 1-(4-methoxyphenyl)-4-methylpent-1-en-3-one [FL-no: 07.049] cannot be evaluated through the Procedure. The Panel further concluded that 4-(2,3,6-trimethylphenyl)but-3-en-2-one [FL-no: 07.206] is to be considered as a stand-alone substance due to the presence of the methyl groups, therefore, in vitro genotoxicity data were requested for [FL-no: 07.206]. Industry communicated that the evaluation of [FL-no: 07.206] is not supported any longer, therefore additional data were not submitted.

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KW - β-unsaturated cinnamyl ketones

KW - flavouring substances

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KW - FGE.19

KW - subgroup 3.2

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