Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19

Maged Younes; Gabriele Aquilina; Laurence Castle; Karl-Heinz Engel; Paul Fowler; Maria Jose Frutos Fernandez; Peter Fürst; Rainer Gürtler; Ursula Gundert-Remy; 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; Natalia Kovalkovicova; Carla Martino; Giorgia Vianello; Wim Mennes; EFSA Panel on Food Additives and Flavourings (FAF)

doi:10.2903/j.efsa.2019.5569

Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19

Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Rainer Gürtler, Ursula Gundert-Remy, 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, Natalia Kovalkovicova, Carla Martino, 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 EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p-mentha-1,8-dien-7-al [FL-no: 05.117], which was found to be genotoxic in vivo. The Panel concluded that there was a potential safety concern for the nine substances in this FGE that were all represented by [FL-no: 05.177]. Consequently, substance [FL-no: 05.117], as well as four substances ([FL-no: 05.121, 09.272, 09.899 and 09.900]), no longer supported by industry were deleted from the Union List. In FGE.208Rev2, the Panel assessed genotoxicity studies submitted on five flavouring substances [FL-no: 02.060, 02.091, 05.106, 09.278 and 09.302] and concluded that the concern for genotoxicity could be ruled out for these substances, except from myrtenal [FL-no: 05.106] for which the available data were considered equivocal. Thus, industry provided additional genotoxicity studies (a bacterial reverse mutation assay and a combined in vivo bone marrow erythrocytes micronucleus test and Comet assay in liver and duodenum) for this substance which were evaluated in the present opinion, FGE.208Rev3. Based on these new data, the Panel concluded that the concern for genotoxicity could be ruled out for myrtenal [FL-no: 05.106]. Subsequently, this substance can be evaluated through the Procedure.

Original language	English
Pages	e05569
Number of pages	50
Volume	17
No.	1
Specialist publication	EFSA Journal
DOIs	https://doi.org/10.2903/j.efsa.2019.5569
Publication status	Published - Jan 2019

Keywords

FGE.19
subgroup 2.2
alicyclic aldehydes
α
β-unsaturated

UN SDGs

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

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Younes, M., Aquilina, G., Castle, L., Engel, K-H., Fowler, P., Frutos Fernandez, M. J., Fürst, P., Gürtler, R., Gundert-Remy, U., 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 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19. EFSA Journal, 17(1), e05569. https://doi.org/10.2903/j.efsa.2019.5569

Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3) : consideration of genotoxicity data on alicyclic aldehydes with α,β-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19. / Younes, Maged; Aquilina, Gabriele; Castle, Laurence et al.

In: EFSA Journal, Vol. 17, No. 1, 01.2019, p. e05569.

Research output: Contribution to specialist publication › Article

Younes, M, Aquilina, G, Castle, L, Engel, K-H, Fowler, P, Frutos Fernandez, MJ, Fürst, P, Gürtler, R, Gundert-Remy, U, 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, Kovalkovicova, N, Martino, C, Vianello, G, Mennes, W & EFSA Panel on Food Additives and Flavourings (FAF) 2019, 'Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19' EFSA Journal, vol. 17, no. 1, pp. e05569. https://doi.org/10.2903/j.efsa.2019.5569

Younes M, Aquilina G, Castle L, Engel K-H, Fowler P, Frutos Fernandez MJ et al. Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19. EFSA Journal. 2019 Jan;17(1):e05569. Epub 2019 Jan 11. doi: 10.2903/j.efsa.2019.5569

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title = "Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19",

abstract = "The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p-mentha-1,8-dien-7-al [FL-no: 05.117], which was found to be genotoxic in vivo. The Panel concluded that there was a potential safety concern for the nine substances in this FGE that were all represented by [FL-no: 05.177]. Consequently, substance [FL-no: 05.117], as well as four substances ([FL-no: 05.121, 09.272, 09.899 and 09.900]), no longer supported by industry were deleted from the Union List. In FGE.208Rev2, the Panel assessed genotoxicity studies submitted on five flavouring substances [FL-no: 02.060, 02.091, 05.106, 09.278 and 09.302] and concluded that the concern for genotoxicity could be ruled out for these substances, except from myrtenal [FL-no: 05.106] for which the available data were considered equivocal. Thus, industry provided additional genotoxicity studies (a bacterial reverse mutation assay and a combined in vivo bone marrow erythrocytes micronucleus test and Comet assay in liver and duodenum) for this substance which were evaluated in the present opinion, FGE.208Rev3. Based on these new data, the Panel concluded that the concern for genotoxicity could be ruled out for myrtenal [FL-no: 05.106]. Subsequently, this substance can be evaluated through the Procedure.",

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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 Rainer G{\"u}rtler and Ursula Gundert-Remy 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 Natalia Kovalkovicova and Carla Martino and Giorgia Vianello and Wim Mennes and {EFSA Panel on Food Additives and Flavourings (FAF)}",

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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 - Gürtler, Rainer

AU - Gundert-Remy, Ursula

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 - Kovalkovicova, Natalia

AU - Martino, Carla

AU - Vianello, Giorgia

AU - Mennes, Wim

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

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