Scientific Opinion on Flavouring Group Evaluation 204 Revision 1 (FGE.204Rev1): consideration of genotoxicity data on representatives for 17 monounsaturated, aliphatic, α,β-unsaturated ketones and precursors from chemical subgroup 1.2.1 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; Giorgia Vianello; Wim Mennes; EFSA Panel on Food Additives and Flavourings (FAF)

doi:10.2903/j.efsa.2019.5750

Scientific Opinion on Flavouring Group Evaluation 204 Revision 1 (FGE.204Rev1): consideration of genotoxicity data on representatives for 17 monounsaturated, aliphatic, α,β-unsaturated ketones and precursors from chemical subgroup 1.2.1 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, Giorgia Vianello, Wim Mennes, EFSA Panel on Food Additives and Flavourings (FAF)

Research output: Contribution to specialist publication › Article

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Abstract

The Panel on Food Additives and Flavourings (FAF Panel) of the European Food Safety Authority was requested to evaluate the genotoxic potential of the flavouring substances from subgroup 1.2.1 of FGE.19 in the Flavouring Group Evaluation 204 (FGE.204). In the present revision of this FGE (FGE.204Rev1), the FAF Panel evaluated new data provided by Industry following a request from the former Panel on Food Contact materials, Enzymes, Flavourings and Processing Aids (CEF Panel). This request followed from positive results in an in vitro micronucleus test for clastogenicity and a negative result, but with no proof of bone marrow exposure, in an in vivo micronucleus assay for the representative substance 7-methyl-3-octenone-2 [FL-no: 07.177]. Subsequently, the Industry submitted an in vivo comet assay which was considered equivocal in the liver. The study was repeated confirming that 7-methyl-3-octenone-2 [FL-no: 07.177] did not induce primary DNA damage in the liver and duodenum. Based on the available data, the Panel concluded that the concern for genotoxicity can be ruled out for [FL-no: 07.177] and the 15 structurally related substances [FL-no: 02.102, 02.193, 07.044, 07.048, 07.082, 07.104, 07.105, 07.106, 07.107, 07.121, 07.139, 07.187, 07.188, 07.244, 07.258] which can be evaluated through the Procedure for flavouring substances.

Original language	English
Pages	e05750
Number of pages	26
Volume	17
No.	7
Specialist publication	EFSA Journal
DOIs	https://doi.org/10.2903/j.efsa.2019.5750
Publication status	Published - 17 Jul 2019

Keywords

FGE.19
subgroup 1.2.1
aliphatic
mono-unsaturated
α
β-unsaturated ketones

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-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. https://creativecommons.org/licenses/by-nd/4.0/
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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 204 Revision 1 (FGE.204Rev1): consideration of genotoxicity data on representatives for 17 monounsaturated, aliphatic, α,β-unsaturated ketones and precursors from chemical subgroup 1.2.1 of FGE.19. EFSA Journal, 17(7), e05750. https://doi.org/10.2903/j.efsa.2019.5750

Scientific Opinion on Flavouring Group Evaluation 204 Revision 1 (FGE.204Rev1): consideration of genotoxicity data on representatives for 17 monounsaturated, aliphatic, α,β-unsaturated ketones and precursors from chemical subgroup 1.2.1 of FGE.19. / Younes, Maged; Aquilina, Gabriele; Castle, Laurence et al.

In: EFSA Journal, Vol. 17, No. 7, 17.07.2019, p. e05750.

Research output: Contribution to specialist publication › Article

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, Vianello, G, Mennes, W & EFSA Panel on Food Additives and Flavourings (FAF) 2019, 'Scientific Opinion on Flavouring Group Evaluation 204 Revision 1 (FGE.204Rev1): consideration of genotoxicity data on representatives for 17 monounsaturated, aliphatic, α,β-unsaturated ketones and precursors from chemical subgroup 1.2.1 of FGE.19' EFSA Journal, vol. 17, no. 7, pp. e05750. https://doi.org/10.2903/j.efsa.2019.5750

Younes M, Aquilina G, Castle L, Engel K-H, Fowler P, Frutos Fernandez MJ et al. Scientific Opinion on Flavouring Group Evaluation 204 Revision 1 (FGE.204Rev1): consideration of genotoxicity data on representatives for 17 monounsaturated, aliphatic, α,β-unsaturated ketones and precursors from chemical subgroup 1.2.1 of FGE.19. EFSA Journal. 2019 Jul 17;17(7):e05750. Epub 2019 Jul 17. doi: 10.2903/j.efsa.2019.5750

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title = "Scientific Opinion on Flavouring Group Evaluation 204 Revision 1 (FGE.204Rev1): consideration of genotoxicity data on representatives for 17 monounsaturated, aliphatic, α,β-unsaturated ketones and precursors from chemical subgroup 1.2.1 of FGE.19",

abstract = "The Panel on Food Additives and Flavourings (FAF Panel) of the European Food Safety Authority was requested to evaluate the genotoxic potential of the flavouring substances from subgroup 1.2.1 of FGE.19 in the Flavouring Group Evaluation 204 (FGE.204). In the present revision of this FGE (FGE.204Rev1), the FAF Panel evaluated new data provided by Industry following a request from the former Panel on Food Contact materials, Enzymes, Flavourings and Processing Aids (CEF Panel). This request followed from positive results in an in vitro micronucleus test for clastogenicity and a negative result, but with no proof of bone marrow exposure, in an in vivo micronucleus assay for the representative substance 7-methyl-3-octenone-2 [FL-no: 07.177]. Subsequently, the Industry submitted an in vivo comet assay which was considered equivocal in the liver. The study was repeated confirming that 7-methyl-3-octenone-2 [FL-no: 07.177] did not induce primary DNA damage in the liver and duodenum. Based on the available data, the Panel concluded that the concern for genotoxicity can be ruled out for [FL-no: 07.177] and the 15 structurally related substances [FL-no: 02.102, 02.193, 07.044, 07.048, 07.082, 07.104, 07.105, 07.106, 07.107, 07.121, 07.139, 07.187, 07.188, 07.244, 07.258] which can be evaluated through the Procedure for flavouring substances.",

keywords = "FGE.19, subgroup 1.2.1, aliphatic, mono-unsaturated, α, β-unsaturated ketones",

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 Giorgia Vianello 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: Jose Cortinas Abrahantes for the support provided to this scienti fic output.",

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doi = "10.2903/j.efsa.2019.5750",

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T1 - Scientific Opinion on Flavouring Group Evaluation 204 Revision 1 (FGE.204Rev1): consideration of genotoxicity data on representatives for 17 monounsaturated, aliphatic, α,β-unsaturated ketones and precursors from chemical subgroup 1.2.1 of FGE.19

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 - Vianello, Giorgia

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: Jose Cortinas Abrahantes for the support provided to this scienti fic output.

PY - 2019/7/17

Y1 - 2019/7/17

N2 - The Panel on Food Additives and Flavourings (FAF Panel) of the European Food Safety Authority was requested to evaluate the genotoxic potential of the flavouring substances from subgroup 1.2.1 of FGE.19 in the Flavouring Group Evaluation 204 (FGE.204). In the present revision of this FGE (FGE.204Rev1), the FAF Panel evaluated new data provided by Industry following a request from the former Panel on Food Contact materials, Enzymes, Flavourings and Processing Aids (CEF Panel). This request followed from positive results in an in vitro micronucleus test for clastogenicity and a negative result, but with no proof of bone marrow exposure, in an in vivo micronucleus assay for the representative substance 7-methyl-3-octenone-2 [FL-no: 07.177]. Subsequently, the Industry submitted an in vivo comet assay which was considered equivocal in the liver. The study was repeated confirming that 7-methyl-3-octenone-2 [FL-no: 07.177] did not induce primary DNA damage in the liver and duodenum. Based on the available data, the Panel concluded that the concern for genotoxicity can be ruled out for [FL-no: 07.177] and the 15 structurally related substances [FL-no: 02.102, 02.193, 07.044, 07.048, 07.082, 07.104, 07.105, 07.106, 07.107, 07.121, 07.139, 07.187, 07.188, 07.244, 07.258] which can be evaluated through the Procedure for flavouring substances.

AB - The Panel on Food Additives and Flavourings (FAF Panel) of the European Food Safety Authority was requested to evaluate the genotoxic potential of the flavouring substances from subgroup 1.2.1 of FGE.19 in the Flavouring Group Evaluation 204 (FGE.204). In the present revision of this FGE (FGE.204Rev1), the FAF Panel evaluated new data provided by Industry following a request from the former Panel on Food Contact materials, Enzymes, Flavourings and Processing Aids (CEF Panel). This request followed from positive results in an in vitro micronucleus test for clastogenicity and a negative result, but with no proof of bone marrow exposure, in an in vivo micronucleus assay for the representative substance 7-methyl-3-octenone-2 [FL-no: 07.177]. Subsequently, the Industry submitted an in vivo comet assay which was considered equivocal in the liver. The study was repeated confirming that 7-methyl-3-octenone-2 [FL-no: 07.177] did not induce primary DNA damage in the liver and duodenum. Based on the available data, the Panel concluded that the concern for genotoxicity can be ruled out for [FL-no: 07.177] and the 15 structurally related substances [FL-no: 02.102, 02.193, 07.044, 07.048, 07.082, 07.104, 07.105, 07.106, 07.107, 07.121, 07.139, 07.187, 07.188, 07.244, 07.258] which can be evaluated through the Procedure for flavouring substances.

KW - FGE.19

KW - subgroup 1.2.1

KW - aliphatic

KW - mono-unsaturated

KW - α

KW - β-unsaturated ketones

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DO - 10.2903/j.efsa.2019.5750

M3 - Article

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