Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Maged Younes; Gabriele Aquilina; Laurence Castle; Karl-Heinz Engel; Paul Fowler; Maria Jose Frutos Fernandez; Peter Fürst; Ursula Gundert-Remy; Trine Husøy; Wim Mennes; Peter Moldeus; Agneta Oskarsson; Sandra Rainieri; Romina Shah; Ine Waalkens-Berendsen; Detlef Wölfle; Mona-Lise Binderup; Claudia Bolognesi; Francesca Marcon; Daniel Marzin; Pasquale Mosesso; Maria Carfì; Giorgia Vianello; Rainer Gürtler; EFSA Panel on Food Additives and Flavourings (FAF)

doi:10.2903/j.efsa.2018.5422

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Ursula Gundert-Remy, Trine Husøy, Wim Mennes, Peter Moldeus, Agneta Oskarsson, Sandra Rainieri, Romina Shah, Ine Waalkens-Berendsen, Detlef Wölfle, Mona-Lise Binderup, Claudia Bolognesi, Francesca Marcon, Daniel MarzinPasquale Mosesso, Maria Carfì, Giorgia Vianello, Rainer Gürtler, EFSA Panel on Food Additives and Flavourings (FAF)

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Abstract

The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex-2(trans)-enal [FL-no: 05.073], and for other two substances in the same subgroup, namely 2-dodecenal [FL-no: 05.037] and 2-nonenal [FL-no: 05.171]. The Panel concluded that the concern still remains with respect to genotoxicity for the substances of this subgroup and requested an in vivo Comet assay performed in duodenum and liver for hex-2(trans)-enal [FL-no: 05.073]. For the two other representative substances of subgroup 1.1.1 (nona-2(trans),6(cis)-dienal [FL-no: 05.058] and oct-2-enal [FL-no: 05.060]), the Panel requested a combined in vivo Comet assay and micronucleus assay. These data have been provided and are evaluated in the present opinion FGE.200 Rev1. Industry submitted genotoxicity studies on trans-2-octenal [FL-no: 05.190], instead of oct-2-enal [FL-no: 05.060]. Based on the available data, the Panel concluded that the concern for genotoxicity can be ruled out for hex-2(trans)-enal [FL-no: 05.073], trans-2-octenal [FL-no: 05.190] and nona-2(trans),6(cis)-dienal [FL-no: 05.058], therefore all the 74 substances [FL-no: 02.020, 02.049, 02.050, 02.090, 02.112, 02.137, 02.156, 02.192, 02.210, 02.231, 05.037, 05.058, 05.060, 05.070, 05.072, 05.073, 05.076, 05.078, 05.102, 05.109, 05.111, 05.114, 05.120, 05.144, 05.150, 05.171, 05.172, 05.179, 05.184, 05.189, 05.190, 05.191, 05.195, 06.025, 06.031, 06.072, 09.054, 09.097, 09.109, 09.119, 09.146, 09.233, 09.244, 09.247, 09.276, 09.277, 09.303, 09.312, 09.385, 09.394, 09.395, 09.396, 09.397, 09.398, 09.399, 09.400, 09.410, 09.411, 09.469, 09.482, 09.489, 09.492, 09.493, 09.498, 09.678, 09.701, 09.719, 09.741, 09.790, 09.841, 09.866, 09.947, 09.948, 13.004] can be evaluated through the Procedure for flavouring substances.

Original language	English
Number of pages	60
Volume	16
No.	10
Specialist publication	EFSA Journal
DOIs	https://doi.org/10.2903/j.efsa.2018.5422
Publication status	Published - Oct 2018

Keywords

a,b-unsaturated aldehydes
straight chain
FGE.200
flavouring substances
safety evaluation
subgroup 1.1.1
FGE.19

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© 2018 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., Husøy, T., Mennes, W., Moldeus, P., Oskarsson, A., Rainieri, S., Shah, R., Waalkens-Berendsen, I., Wölfle, D., Binderup, M-L., Bolognesi, C., Marcon, F., ... EFSA Panel on Food Additives and Flavourings (FAF) (2018). Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19. EFSA Journal, 16(10). https://doi.org/10.2903/j.efsa.2018.5422

Younes, M, Aquilina, G, Castle, L, Engel, K-H, Fowler, P, Frutos Fernandez, MJ, Fürst, P, Gundert-Remy, U, Husøy, T, Mennes, W, Moldeus, P, Oskarsson, A, Rainieri, S, Shah, R, Waalkens-Berendsen, I, Wölfle, D, Binderup, M-L, Bolognesi, C, Marcon, F, Marzin, D, Mosesso, P, Carfì, M, Vianello, G, Gürtler, R & EFSA Panel on Food Additives and Flavourings (FAF) 2018, 'Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19' EFSA Journal, vol. 16, no. 10. https://doi.org/10.2903/j.efsa.2018.5422

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title = "Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19",

abstract = "The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex-2(trans)-enal [FL-no: 05.073], and for other two substances in the same subgroup, namely 2-dodecenal [FL-no: 05.037] and 2-nonenal [FL-no: 05.171]. The Panel concluded that the concern still remains with respect to genotoxicity for the substances of this subgroup and requested an in vivo Comet assay performed in duodenum and liver for hex-2(trans)-enal [FL-no: 05.073]. For the two other representative substances of subgroup 1.1.1 (nona-2(trans),6(cis)-dienal [FL-no: 05.058] and oct-2-enal [FL-no: 05.060]), the Panel requested a combined in vivo Comet assay and micronucleus assay. These data have been provided and are evaluated in the present opinion FGE.200 Rev1. Industry submitted genotoxicity studies on trans-2-octenal [FL-no: 05.190], instead of oct-2-enal [FL-no: 05.060]. Based on the available data, the Panel concluded that the concern for genotoxicity can be ruled out for hex-2(trans)-enal [FL-no: 05.073], trans-2-octenal [FL-no: 05.190] and nona-2(trans),6(cis)-dienal [FL-no: 05.058], therefore all the 74 substances [FL-no: 02.020, 02.049, 02.050, 02.090, 02.112, 02.137, 02.156, 02.192, 02.210, 02.231, 05.037, 05.058, 05.060, 05.070, 05.072, 05.073, 05.076, 05.078, 05.102, 05.109, 05.111, 05.114, 05.120, 05.144, 05.150, 05.171, 05.172, 05.179, 05.184, 05.189, 05.190, 05.191, 05.195, 06.025, 06.031, 06.072, 09.054, 09.097, 09.109, 09.119, 09.146, 09.233, 09.244, 09.247, 09.276, 09.277, 09.303, 09.312, 09.385, 09.394, 09.395, 09.396, 09.397, 09.398, 09.399, 09.400, 09.410, 09.411, 09.469, 09.482, 09.489, 09.492, 09.493, 09.498, 09.678, 09.701, 09.719, 09.741, 09.790, 09.841, 09.866, 09.947, 09.948, 13.004] can be evaluated through the Procedure for flavouring substances.",

keywords = "a,b-unsaturated aldehydes, straight chain, FGE.200, flavouring substances, safety evaluation, subgroup 1.1.1, FGE.19",

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 Trine Hus{\o}y and Wim Mennes and Peter Moldeus and Agneta Oskarsson and Sandra Rainieri and Romina Shah and Ine Waalkens-Berendsen and Detlef W{\"o}lfle and Mona-Lise Binderup and Claudia Bolognesi and Francesca Marcon and Daniel Marzin and Pasquale Mosesso and Maria Carf{\`i} and Giorgia Vianello and Rainer G{\"u}rtler and {EFSA Panel on Food Additives and Flavourings (FAF)}",

year = "2018",

month = oct,

doi = "10.2903/j.efsa.2018.5422",

language = "English",

volume = "16",

journal = "EFSA Journal",

issn = "1831-4732",

publisher = "John Wiley & Sons, Ltd",

}

TY - GEN

T1 - Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1)

T2 - 74 α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 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 - Husøy, Trine

AU - Mennes, Wim

AU - Moldeus, Peter

AU - Oskarsson, Agneta

AU - Rainieri, Sandra

AU - Shah, Romina

AU - Waalkens-Berendsen, Ine

AU - Wölfle, Detlef

AU - Binderup, Mona-Lise

AU - Bolognesi, Claudia

AU - Marcon, Francesca

AU - Marzin, Daniel

AU - Mosesso, Pasquale

AU - Carfì, Maria

AU - Vianello, Giorgia

AU - Gürtler, Rainer

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

PY - 2018/10

Y1 - 2018/10

N2 - The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex-2(trans)-enal [FL-no: 05.073], and for other two substances in the same subgroup, namely 2-dodecenal [FL-no: 05.037] and 2-nonenal [FL-no: 05.171]. The Panel concluded that the concern still remains with respect to genotoxicity for the substances of this subgroup and requested an in vivo Comet assay performed in duodenum and liver for hex-2(trans)-enal [FL-no: 05.073]. For the two other representative substances of subgroup 1.1.1 (nona-2(trans),6(cis)-dienal [FL-no: 05.058] and oct-2-enal [FL-no: 05.060]), the Panel requested a combined in vivo Comet assay and micronucleus assay. These data have been provided and are evaluated in the present opinion FGE.200 Rev1. Industry submitted genotoxicity studies on trans-2-octenal [FL-no: 05.190], instead of oct-2-enal [FL-no: 05.060]. Based on the available data, the Panel concluded that the concern for genotoxicity can be ruled out for hex-2(trans)-enal [FL-no: 05.073], trans-2-octenal [FL-no: 05.190] and nona-2(trans),6(cis)-dienal [FL-no: 05.058], therefore all the 74 substances [FL-no: 02.020, 02.049, 02.050, 02.090, 02.112, 02.137, 02.156, 02.192, 02.210, 02.231, 05.037, 05.058, 05.060, 05.070, 05.072, 05.073, 05.076, 05.078, 05.102, 05.109, 05.111, 05.114, 05.120, 05.144, 05.150, 05.171, 05.172, 05.179, 05.184, 05.189, 05.190, 05.191, 05.195, 06.025, 06.031, 06.072, 09.054, 09.097, 09.109, 09.119, 09.146, 09.233, 09.244, 09.247, 09.276, 09.277, 09.303, 09.312, 09.385, 09.394, 09.395, 09.396, 09.397, 09.398, 09.399, 09.400, 09.410, 09.411, 09.469, 09.482, 09.489, 09.492, 09.493, 09.498, 09.678, 09.701, 09.719, 09.741, 09.790, 09.841, 09.866, 09.947, 09.948, 13.004] can be evaluated through the Procedure for flavouring substances.

AB - The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex-2(trans)-enal [FL-no: 05.073], and for other two substances in the same subgroup, namely 2-dodecenal [FL-no: 05.037] and 2-nonenal [FL-no: 05.171]. The Panel concluded that the concern still remains with respect to genotoxicity for the substances of this subgroup and requested an in vivo Comet assay performed in duodenum and liver for hex-2(trans)-enal [FL-no: 05.073]. For the two other representative substances of subgroup 1.1.1 (nona-2(trans),6(cis)-dienal [FL-no: 05.058] and oct-2-enal [FL-no: 05.060]), the Panel requested a combined in vivo Comet assay and micronucleus assay. These data have been provided and are evaluated in the present opinion FGE.200 Rev1. Industry submitted genotoxicity studies on trans-2-octenal [FL-no: 05.190], instead of oct-2-enal [FL-no: 05.060]. Based on the available data, the Panel concluded that the concern for genotoxicity can be ruled out for hex-2(trans)-enal [FL-no: 05.073], trans-2-octenal [FL-no: 05.190] and nona-2(trans),6(cis)-dienal [FL-no: 05.058], therefore all the 74 substances [FL-no: 02.020, 02.049, 02.050, 02.090, 02.112, 02.137, 02.156, 02.192, 02.210, 02.231, 05.037, 05.058, 05.060, 05.070, 05.072, 05.073, 05.076, 05.078, 05.102, 05.109, 05.111, 05.114, 05.120, 05.144, 05.150, 05.171, 05.172, 05.179, 05.184, 05.189, 05.190, 05.191, 05.195, 06.025, 06.031, 06.072, 09.054, 09.097, 09.109, 09.119, 09.146, 09.233, 09.244, 09.247, 09.276, 09.277, 09.303, 09.312, 09.385, 09.394, 09.395, 09.396, 09.397, 09.398, 09.399, 09.400, 09.410, 09.411, 09.469, 09.482, 09.489, 09.492, 09.493, 09.498, 09.678, 09.701, 09.719, 09.741, 09.790, 09.841, 09.866, 09.947, 09.948, 13.004] can be evaluated through the Procedure for flavouring substances.

KW - a,b-unsaturated aldehydes

KW - straight chain

KW - FGE.200

KW - flavouring substances

KW - safety evaluation

KW - subgroup 1.1.1

KW - FGE.19

U2 - 10.2903/j.efsa.2018.5422

DO - 10.2903/j.efsa.2018.5422

M3 - Article

C2 - 32625707

VL - 16

JO - EFSA Journal

JF - EFSA Journal

SN - 1831-4732

ER -

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

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