Scientific Opinion on Flavouring Group Evaluation 203, Revision 2 (FGE.203Rev2): α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double-bonds and with or without additional non-conjugated double-bonds

Vittorio Silano; Claudia Bolognesi; Laurence Castle; Kevin Chipman; Jean-Pierre Cravedi; Karl-Heinz Engel; Paul Fowler; Roland Franz; Konrad Grob; Trine Husøy; Sirpa Kärenlampi; Wim Mennes; Maria Rosaria Milana; Karla Pfaff; Gilles Riviere; Jannavi Srinivasan; Maria de Fátima Tavares Poças; Christina Tlustos; Detlef Wölfle; Holger Zorn; Mona-Lise Binderup; Francesca Marcon; Daniel Marzin; Pasquale Mosesso; Maria Anastassiadou; Maria Carfì; Rainer Gürtler; EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

doi:10.2903/j.efsa.2018.5322

Scientific Opinion on Flavouring Group Evaluation 203, Revision 2 (FGE.203Rev2): α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double-bonds and with or without additional non-conjugated double-bonds

Vittorio Silano
, Claudia Bolognesi
, Laurence Castle
, Kevin Chipman
, Jean-Pierre Cravedi
, Karl-Heinz Engel
, Paul Fowler
, Roland Franz
, Konrad Grob
, Trine Husøy
, Sirpa Kärenlampi
, Wim Mennes
, Maria Rosaria Milana
, Karla Pfaff
, Gilles Riviere
, Jannavi Srinivasan
, Maria de Fátima Tavares Poças
, Christina Tlustos
, Detlef Wölfle
, Holger Zorn

Mona-Lise Binderup, Francesca Marcon, Daniel Marzin, Pasquale Mosesso, Maria Anastassiadou, Maria Carfì, Rainer Gürtler, EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

Research output: Contribution to specialist publication › Article

7 Citations (Scopus)

11 Downloads (Pure)

Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of flavouring substances from subgroup 1.1.4 of FGE.19 in the Flavouring Group Evaluation 203 Revision 2 (FGE.203Rev2). In FGE. 203 Revision 1, the Panel concluded that the genotoxic potential could not be ruled out for the flavouring substances in this FGE. The Flavour Industry provided additional genotoxicity studies for the representative substances of FGE.19 subgroup 1.1.4, namely deca-2(trans),4(trans)-dienal [FL-no: 05.140] and hexa-2(trans),4(trans)-dienal [FL-no: 05.057]. In addition, new studies on hepta-2,4-dienal [FL-no: 05.084], 2,4-octadienal [FL-no: 05.186] and tr-2,tr-4-nonadienal [FL-no: 05.194] were provided that are evaluated in the present revision of FGE.203, i.e. FGE.203Rev2. Hepta-2,4-dienal [FL-no: 05.084], 2,4-octadienal [FL-no: 05.186] and tr-2,tr-4-nonadienal [FL-no: 05.194] did not induce gene mutations in bacteria. Hexa-2(trans),4(trans)-dienal [FL-no: 05.057] did not induce gene mutations in vitro in mammalian cells. Hexa-2(trans),4(trans)-dienal [FL-no: 05.057] was also tested in an in vivo gene mutation assay giving negative results. Both hexa-2(trans),4(trans)-dienal [FL-no: 05.057] and deca-2(trans),4(trans)-dienal [FL-no: 05.140] were tested in vivo for the induction of micronuclei in rats bone marrow and peripheral reticulocytes after oral or intraperitoneal administration. None of the two substances induced increased frequencies of micronuclei. The Panel concluded that the concern for genotoxicity can be ruled out for the representative substances hexa-2(trans),4(trans)-dienal [FL-no: 05.057] and deca-2(trans),4(trans)-dienal [FL-no: 05.140] and therefore also for the other substances in this group [FL-no: 02.139, 02.153, 02.162, 02.188, 05.064, 05.071, 05.081, 05.084, 05.101, 05.108, 05.125, 05.127, 05.141, 05.173, 05.186, 05.194, 05.196, 09.573]. These 20 substances can be evaluated using the Procedure for the evaluation of flavouring substances.

Original language	English
Pages	e05322
Number of pages	39
Volume	16
No.	7
Specialist publication	EFSA Journal
DOIs	https://doi.org/10.2903/j.efsa.2018.5322
Publication status	Published - 20 Jul 2021

Bibliographical note

cknowledgements: The Panel wishes to thank the hearing experts: Vibe Beltoft and Karin Nørbyand EFSA staff: Annamaria Rossi for the support provided to this scientic output.

UN SDGs

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

SDG 3 Good Health and Well-being

Keywords

a,b-unsaturated aldehydes
straight chain
FGE.203
,b-unsaturated conjugated double-bonds
FGE.19
subgroup 1.1.4

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Silano, V., Bolognesi, C., Castle, L., Chipman, K., Cravedi, J.-P., Engel, K.-H., Fowler, P., Franz, R., Grob, K., Husøy, T., Kärenlampi, S., Mennes, W., Milana, M. R., Pfaff, K., Riviere, G., Srinivasan, J., Tavares Poças, M. D. F., Tlustos, C., Wölfle, D., ... EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) (2021). Scientific Opinion on Flavouring Group Evaluation 203, Revision 2 (FGE.203Rev2): α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double-bonds and with or without additional non-conjugated double-bonds. EFSA Journal, 16(7), e05322. https://doi.org/10.2903/j.efsa.2018.5322

Scientific Opinion on Flavouring Group Evaluation 203, Revision 2 (FGE.203Rev2): α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double-bonds and with or without additional non-conjugated double-bonds. / Silano, Vittorio; Bolognesi, Claudia; Castle, Laurence et al.
In: EFSA Journal, Vol. 16, No. 7, 20.07.2021, p. e05322.

Research output: Contribution to specialist publication › Article

Silano, V, Bolognesi, C, Castle, L, Chipman, K, Cravedi, J-P, Engel, K-H, Fowler, P, Franz, R, Grob, K, Husøy, T, Kärenlampi, S, Mennes, W, Milana, MR, Pfaff, K, Riviere, G, Srinivasan, J, Tavares Poças, MDF, Tlustos, C, Wölfle, D, Zorn, H, Binderup, M-L, Marcon, F, Marzin, D, Mosesso, P, Anastassiadou, M, Carfì, M, Gürtler, R & EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 2021, 'Scientific Opinion on Flavouring Group Evaluation 203, Revision 2 (FGE.203Rev2): α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double-bonds and with or without additional non-conjugated double-bonds' EFSA Journal, vol. 16, no. 7, pp. e05322. https://doi.org/10.2903/j.efsa.2018.5322

Silano V, Bolognesi C, Castle L, Chipman K, Cravedi JP, Engel KH et al. Scientific Opinion on Flavouring Group Evaluation 203, Revision 2 (FGE.203Rev2): α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double-bonds and with or without additional non-conjugated double-bonds. EFSA Journal. 2021 Jul 20;16(7):e05322. Epub 2021 Jul 20. doi: 10.2903/j.efsa.2018.5322

Silano, Vittorio ; Bolognesi, Claudia ; Castle, Laurence et al. / Scientific Opinion on Flavouring Group Evaluation 203, Revision 2 (FGE.203Rev2): α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double-bonds and with or without additional non-conjugated double-bonds. In: EFSA Journal. 2021 ; Vol. 16, No. 7. pp. e05322.

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title = "Scientific Opinion on Flavouring Group Evaluation 203, Revision 2 (FGE.203Rev2): α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double-bonds and with or without additional non-conjugated double-bonds",

abstract = "The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of flavouring substances from subgroup 1.1.4 of FGE.19 in the Flavouring Group Evaluation 203 Revision 2 (FGE.203Rev2). In FGE. 203 Revision 1, the Panel concluded that the genotoxic potential could not be ruled out for the flavouring substances in this FGE. The Flavour Industry provided additional genotoxicity studies for the representative substances of FGE.19 subgroup 1.1.4, namely deca-2(trans),4(trans)-dienal [FL-no: 05.140] and hexa-2(trans),4(trans)-dienal [FL-no: 05.057]. In addition, new studies on hepta-2,4-dienal [FL-no: 05.084], 2,4-octadienal [FL-no: 05.186] and tr-2,tr-4-nonadienal [FL-no: 05.194] were provided that are evaluated in the present revision of FGE.203, i.e. FGE.203Rev2. Hepta-2,4-dienal [FL-no: 05.084], 2,4-octadienal [FL-no: 05.186] and tr-2,tr-4-nonadienal [FL-no: 05.194] did not induce gene mutations in bacteria. Hexa-2(trans),4(trans)-dienal [FL-no: 05.057] did not induce gene mutations in vitro in mammalian cells. Hexa-2(trans),4(trans)-dienal [FL-no: 05.057] was also tested in an in vivo gene mutation assay giving negative results. Both hexa-2(trans),4(trans)-dienal [FL-no: 05.057] and deca-2(trans),4(trans)-dienal [FL-no: 05.140] were tested in vivo for the induction of micronuclei in rats bone marrow and peripheral reticulocytes after oral or intraperitoneal administration. None of the two substances induced increased frequencies of micronuclei. The Panel concluded that the concern for genotoxicity can be ruled out for the representative substances hexa-2(trans),4(trans)-dienal [FL-no: 05.057] and deca-2(trans),4(trans)-dienal [FL-no: 05.140] and therefore also for the other substances in this group [FL-no: 02.139, 02.153, 02.162, 02.188, 05.064, 05.071, 05.081, 05.084, 05.101, 05.108, 05.125, 05.127, 05.141, 05.173, 05.186, 05.194, 05.196, 09.573]. These 20 substances can be evaluated using the Procedure for the evaluation of flavouring substances.",

keywords = "a,b-unsaturated aldehydes, straight chain, FGE.203, ,b-unsaturated conjugated double-bonds, FGE.19, subgroup 1.1.4",

author = "Vittorio Silano and Claudia Bolognesi and Laurence Castle and Kevin Chipman and Jean-Pierre Cravedi and Karl-Heinz Engel and Paul Fowler and Roland Franz and Konrad Grob and Trine Hus{\o}y and Sirpa K{\"a}renlampi and Wim Mennes and Milana, \{Maria Rosaria\} and Karla Pfaff and Gilles Riviere and Jannavi Srinivasan and \{Tavares Po{\c c}as\}, \{Maria de F{\'a}tima\} and Christina Tlustos and Detlef W{\"o}lfle and Holger Zorn and Mona-Lise Binderup and Francesca Marcon and Daniel Marzin and Pasquale Mosesso and Maria Anastassiadou and Maria Carf{\`i} and Rainer G{\"u}rtler and \{EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)\}",

note = "cknowledgements: The Panel wishes to thank the hearing experts: Vibe Beltoft and Karin N{\o}rbyand EFSA staff: Annamaria Rossi for the support provided to this scientic output.",

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AU - Silano, Vittorio

AU - Bolognesi, Claudia

AU - Castle, Laurence

AU - Chipman, Kevin

AU - Cravedi, Jean-Pierre

AU - Engel, Karl-Heinz

AU - Fowler, Paul

AU - Franz, Roland

AU - Grob, Konrad

AU - Husøy, Trine

AU - Kärenlampi, Sirpa

AU - Mennes, Wim

AU - Milana, Maria Rosaria

AU - Pfaff, Karla

AU - Riviere, Gilles

AU - Srinivasan, Jannavi

AU - Tavares Poças, Maria de Fátima

AU - Tlustos, Christina

AU - Wölfle, Detlef

AU - Zorn, Holger

AU - Binderup, Mona-Lise

AU - Marcon, Francesca

AU - Marzin, Daniel

AU - Mosesso, Pasquale

AU - Anastassiadou, Maria

AU - Carfì, Maria

AU - Gürtler, Rainer

AU - EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

N1 - cknowledgements: The Panel wishes to thank the hearing experts: Vibe Beltoft and Karin Nørbyand EFSA staff: Annamaria Rossi for the support provided to this scientic output.

PY - 2021/7/20

Y1 - 2021/7/20

N2 - The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of flavouring substances from subgroup 1.1.4 of FGE.19 in the Flavouring Group Evaluation 203 Revision 2 (FGE.203Rev2). In FGE. 203 Revision 1, the Panel concluded that the genotoxic potential could not be ruled out for the flavouring substances in this FGE. The Flavour Industry provided additional genotoxicity studies for the representative substances of FGE.19 subgroup 1.1.4, namely deca-2(trans),4(trans)-dienal [FL-no: 05.140] and hexa-2(trans),4(trans)-dienal [FL-no: 05.057]. In addition, new studies on hepta-2,4-dienal [FL-no: 05.084], 2,4-octadienal [FL-no: 05.186] and tr-2,tr-4-nonadienal [FL-no: 05.194] were provided that are evaluated in the present revision of FGE.203, i.e. FGE.203Rev2. Hepta-2,4-dienal [FL-no: 05.084], 2,4-octadienal [FL-no: 05.186] and tr-2,tr-4-nonadienal [FL-no: 05.194] did not induce gene mutations in bacteria. Hexa-2(trans),4(trans)-dienal [FL-no: 05.057] did not induce gene mutations in vitro in mammalian cells. Hexa-2(trans),4(trans)-dienal [FL-no: 05.057] was also tested in an in vivo gene mutation assay giving negative results. Both hexa-2(trans),4(trans)-dienal [FL-no: 05.057] and deca-2(trans),4(trans)-dienal [FL-no: 05.140] were tested in vivo for the induction of micronuclei in rats bone marrow and peripheral reticulocytes after oral or intraperitoneal administration. None of the two substances induced increased frequencies of micronuclei. The Panel concluded that the concern for genotoxicity can be ruled out for the representative substances hexa-2(trans),4(trans)-dienal [FL-no: 05.057] and deca-2(trans),4(trans)-dienal [FL-no: 05.140] and therefore also for the other substances in this group [FL-no: 02.139, 02.153, 02.162, 02.188, 05.064, 05.071, 05.081, 05.084, 05.101, 05.108, 05.125, 05.127, 05.141, 05.173, 05.186, 05.194, 05.196, 09.573]. These 20 substances can be evaluated using the Procedure for the evaluation of flavouring substances.

AB - The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of flavouring substances from subgroup 1.1.4 of FGE.19 in the Flavouring Group Evaluation 203 Revision 2 (FGE.203Rev2). In FGE. 203 Revision 1, the Panel concluded that the genotoxic potential could not be ruled out for the flavouring substances in this FGE. The Flavour Industry provided additional genotoxicity studies for the representative substances of FGE.19 subgroup 1.1.4, namely deca-2(trans),4(trans)-dienal [FL-no: 05.140] and hexa-2(trans),4(trans)-dienal [FL-no: 05.057]. In addition, new studies on hepta-2,4-dienal [FL-no: 05.084], 2,4-octadienal [FL-no: 05.186] and tr-2,tr-4-nonadienal [FL-no: 05.194] were provided that are evaluated in the present revision of FGE.203, i.e. FGE.203Rev2. Hepta-2,4-dienal [FL-no: 05.084], 2,4-octadienal [FL-no: 05.186] and tr-2,tr-4-nonadienal [FL-no: 05.194] did not induce gene mutations in bacteria. Hexa-2(trans),4(trans)-dienal [FL-no: 05.057] did not induce gene mutations in vitro in mammalian cells. Hexa-2(trans),4(trans)-dienal [FL-no: 05.057] was also tested in an in vivo gene mutation assay giving negative results. Both hexa-2(trans),4(trans)-dienal [FL-no: 05.057] and deca-2(trans),4(trans)-dienal [FL-no: 05.140] were tested in vivo for the induction of micronuclei in rats bone marrow and peripheral reticulocytes after oral or intraperitoneal administration. None of the two substances induced increased frequencies of micronuclei. The Panel concluded that the concern for genotoxicity can be ruled out for the representative substances hexa-2(trans),4(trans)-dienal [FL-no: 05.057] and deca-2(trans),4(trans)-dienal [FL-no: 05.140] and therefore also for the other substances in this group [FL-no: 02.139, 02.153, 02.162, 02.188, 05.064, 05.071, 05.081, 05.084, 05.101, 05.108, 05.125, 05.127, 05.141, 05.173, 05.186, 05.194, 05.196, 09.573]. These 20 substances can be evaluated using the Procedure for the evaluation of flavouring substances.

KW - a,b-unsaturated aldehydes

KW - straight chain

KW - FGE.203

KW - ,b-unsaturated conjugated double-bonds

KW - FGE.19

KW - subgroup 1.1.4

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DO - 10.2903/j.efsa.2018.5322

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