Scientific Opinion on Flavouring Group Evaluation 226 Revision 1 (FGE.226Rev1): consideration of genotoxicity data on one α,β-unsaturated aldehyde from chemical subgroup 1.1.1(b) of FGE.19

Flavourings and Processing Aids (CEF) EFSA Panel on Food Contact Materials Enzymes, Vittorio Silano, Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle, Holger Zorn, Corina-Aurelia Zugravu & 9 others Mona-Lise Binderup, Riccardo Crebelli, Francesca Marcon, Daniel Marzin, Pasquale Mosesso, Maria Anastassiadou, Maria Carfì, Siiri Saarma, Rainer Gürtler

Research output: Contribution to specialist publicationArticle

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Abstract

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate the genotoxic potential of one flavouring substance from subgroup 1.1.1(b) of FGE.19 in the Flavouring Group Evaluation 226 (FGE.226). The flavour industry provided genotoxicity studies for the substance 4,5-epoxydec-2(trans)-enal [FL-no: 16.071]. Based on these data, the Panel concluded in FGE.226 that 4,5-epoxydec-2(trans)-enal did not induce gene mutations in bacterial cells but was positive in an in vitro micronucleus assay, so, 4,5-epoxydec-2(trans)-enal is considered an in vitro genotoxic agent. The negative results obtained in an in vivo micronucleus assay cannot overrule the positive results of the in vitro micronucleus assay with and without S9-mix due to the lack of demonstration of bone marrow exposure. Following this, the flavour industry has provided plasma analysis of a satellite group of rats treated with 4,5-epoxydec-2(trans)-enal in order to investigate the systemic exposure of animals in the in vivo micronucleus assay. However, the plasma analysis did not provide enough evidence of target tissue exposure. An in vivo Comet assay in rodents was recommended in FGE.226, in order to investigate possible genotoxic effects at the first site of contact (e.g. stomach/duodenum cells) and in the liver. An in vivo Comet assay in liver and duodenum was provided that suggests that 4,5-epoxydec-2(trans)-enal [FL-no: 16.071] did not induce DNA damage in the duodenum of rats. However, the genotoxic effect observed in vitro was confirmed in the in vivo Comet assay in the liver of rats. The Panel concluded that 4,5-epoxydec-2(trans)-enal [FL-no: 16.071] does raise a safety concern with respect to genotoxicity and, therefore, it cannot be evaluated according to the Procedure.
Original languageEnglish
Pagese04847
Volume15
No.5
Specialist publicationEFSA Journal
PublisherEuropean Food Safety Authority (EFSA)
DOIs
Publication statusPublished - May 2017

Fingerprint

Micronucleus Tests
Aldehydes
Comet Assay
Duodenum
Liver
Industry
DNA Damage
Rodentia
Stomach
Bone Marrow
Safety
Food
Mutation
Enzymes
Genes

Keywords

  • 4,5-epoxydec-2(trans)-enal
  • subgroup 1.1.1(b)
  • FGE.19
  • FGE.226

Cite this

EFSA Panel on Food Contact Materials Enzymes, F. A. P. A. CEF., Silano, V., Bolognesi, C., Castle, L., Cravedi, J-P., Engel, K-H., ... Gürtler, R. (2017). Scientific Opinion on Flavouring Group Evaluation 226 Revision 1 (FGE.226Rev1): consideration of genotoxicity data on one α,β-unsaturated aldehyde from chemical subgroup 1.1.1(b) of FGE.19. EFSA Journal, 15(5), e04847. https://doi.org/10.2903/j.efsa.2017.4847

Scientific Opinion on Flavouring Group Evaluation 226 Revision 1 (FGE.226Rev1): consideration of genotoxicity data on one α,β-unsaturated aldehyde from chemical subgroup 1.1.1(b) of FGE.19. / EFSA Panel on Food Contact Materials Enzymes, Flavourings and Processing Aids (CEF); Silano, Vittorio; Bolognesi, Claudia; Castle, Laurence; Cravedi, Jean-Pierre; Engel, Karl-Heinz; Fowler, Paul; Franz, Roland; Grob, Konrad; Husøy, Trine; Kärenlampi, Sirpa; Mennes, Wim; Milana, Maria Rosaria; Penninks, André; Smith, Andrew; Tavares Poças, Maria de Fátima; Tlustos, Christina; Wölfle, Detlef; Zorn, Holger; Zugravu, Corina-Aurelia; Binderup, Mona-Lise; Crebelli, Riccardo; Marcon, Francesca; Marzin, Daniel; Mosesso, Pasquale; Anastassiadou, Maria; Carfì, Maria; Saarma, Siiri; Gürtler, Rainer.

In: EFSA Journal, Vol. 15, No. 5, 05.2017, p. e04847.

Research output: Contribution to specialist publicationArticle

EFSA Panel on Food Contact Materials Enzymes, FAPACEF, Silano, V, Bolognesi, C, Castle, L, Cravedi, J-P, Engel, K-H, Fowler, P, Franz, R, Grob, K, Husøy, T, Kärenlampi, S, Mennes, W, Milana, MR, Penninks, A, Smith, A, Tavares Poças, MDF, Tlustos, C, Wölfle, D, Zorn, H, Zugravu, C-A, Binderup, M-L, Crebelli, R, Marcon, F, Marzin, D, Mosesso, P, Anastassiadou, M, Carfì, M, Saarma, S & Gürtler, R 2017, 'Scientific Opinion on Flavouring Group Evaluation 226 Revision 1 (FGE.226Rev1): consideration of genotoxicity data on one α,β-unsaturated aldehyde from chemical subgroup 1.1.1(b) of FGE.19' EFSA Journal, vol. 15, no. 5, pp. e04847. https://doi.org/10.2903/j.efsa.2017.4847
EFSA Panel on Food Contact Materials Enzymes, Flavourings and Processing Aids (CEF) ; Silano, Vittorio ; Bolognesi, Claudia ; Castle, Laurence ; Cravedi, Jean-Pierre ; Engel, Karl-Heinz ; Fowler, Paul ; Franz, Roland ; Grob, Konrad ; Husøy, Trine ; Kärenlampi, Sirpa ; Mennes, Wim ; Milana, Maria Rosaria ; Penninks, André ; Smith, Andrew ; Tavares Poças, Maria de Fátima ; Tlustos, Christina ; Wölfle, Detlef ; Zorn, Holger ; Zugravu, Corina-Aurelia ; Binderup, Mona-Lise ; Crebelli, Riccardo ; Marcon, Francesca ; Marzin, Daniel ; Mosesso, Pasquale ; Anastassiadou, Maria ; Carfì, Maria ; Saarma, Siiri ; Gürtler, Rainer. / Scientific Opinion on Flavouring Group Evaluation 226 Revision 1 (FGE.226Rev1): consideration of genotoxicity data on one α,β-unsaturated aldehyde from chemical subgroup 1.1.1(b) of FGE.19. In: EFSA Journal. 2017 ; Vol. 15, No. 5. pp. e04847.
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abstract = "The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate the genotoxic potential of one flavouring substance from subgroup 1.1.1(b) of FGE.19 in the Flavouring Group Evaluation 226 (FGE.226). The flavour industry provided genotoxicity studies for the substance 4,5-epoxydec-2(trans)-enal [FL-no: 16.071]. Based on these data, the Panel concluded in FGE.226 that 4,5-epoxydec-2(trans)-enal did not induce gene mutations in bacterial cells but was positive in an in vitro micronucleus assay, so, 4,5-epoxydec-2(trans)-enal is considered an in vitro genotoxic agent. The negative results obtained in an in vivo micronucleus assay cannot overrule the positive results of the in vitro micronucleus assay with and without S9-mix due to the lack of demonstration of bone marrow exposure. Following this, the flavour industry has provided plasma analysis of a satellite group of rats treated with 4,5-epoxydec-2(trans)-enal in order to investigate the systemic exposure of animals in the in vivo micronucleus assay. However, the plasma analysis did not provide enough evidence of target tissue exposure. An in vivo Comet assay in rodents was recommended in FGE.226, in order to investigate possible genotoxic effects at the first site of contact (e.g. stomach/duodenum cells) and in the liver. An in vivo Comet assay in liver and duodenum was provided that suggests that 4,5-epoxydec-2(trans)-enal [FL-no: 16.071] did not induce DNA damage in the duodenum of rats. However, the genotoxic effect observed in vitro was confirmed in the in vivo Comet assay in the liver of rats. The Panel concluded that 4,5-epoxydec-2(trans)-enal [FL-no: 16.071] does raise a safety concern with respect to genotoxicity and, therefore, it cannot be evaluated according to the Procedure.",
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AU - Silano, Vittorio

AU - Bolognesi, Claudia

AU - Castle, Laurence

AU - Cravedi, Jean-Pierre

AU - Engel, Karl-Heinz

AU - Fowler, Paul

AU - Franz, Roland

AU - Grob, Konrad

AU - Husøy, Trine

AU - Kärenlampi, Sirpa

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AU - Milana, Maria Rosaria

AU - Penninks, André

AU - Smith, Andrew

AU - Tavares Poças, Maria de Fátima

AU - Tlustos, Christina

AU - Wölfle, Detlef

AU - Zorn, Holger

AU - Zugravu, Corina-Aurelia

AU - Binderup, Mona-Lise

AU - Crebelli, Riccardo

AU - Marcon, Francesca

AU - Marzin, Daniel

AU - Mosesso, Pasquale

AU - Anastassiadou, Maria

AU - Carfì, Maria

AU - Saarma, Siiri

AU - Gürtler, Rainer

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N2 - The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate the genotoxic potential of one flavouring substance from subgroup 1.1.1(b) of FGE.19 in the Flavouring Group Evaluation 226 (FGE.226). The flavour industry provided genotoxicity studies for the substance 4,5-epoxydec-2(trans)-enal [FL-no: 16.071]. Based on these data, the Panel concluded in FGE.226 that 4,5-epoxydec-2(trans)-enal did not induce gene mutations in bacterial cells but was positive in an in vitro micronucleus assay, so, 4,5-epoxydec-2(trans)-enal is considered an in vitro genotoxic agent. The negative results obtained in an in vivo micronucleus assay cannot overrule the positive results of the in vitro micronucleus assay with and without S9-mix due to the lack of demonstration of bone marrow exposure. Following this, the flavour industry has provided plasma analysis of a satellite group of rats treated with 4,5-epoxydec-2(trans)-enal in order to investigate the systemic exposure of animals in the in vivo micronucleus assay. However, the plasma analysis did not provide enough evidence of target tissue exposure. An in vivo Comet assay in rodents was recommended in FGE.226, in order to investigate possible genotoxic effects at the first site of contact (e.g. stomach/duodenum cells) and in the liver. An in vivo Comet assay in liver and duodenum was provided that suggests that 4,5-epoxydec-2(trans)-enal [FL-no: 16.071] did not induce DNA damage in the duodenum of rats. However, the genotoxic effect observed in vitro was confirmed in the in vivo Comet assay in the liver of rats. The Panel concluded that 4,5-epoxydec-2(trans)-enal [FL-no: 16.071] does raise a safety concern with respect to genotoxicity and, therefore, it cannot be evaluated according to the Procedure.

AB - The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate the genotoxic potential of one flavouring substance from subgroup 1.1.1(b) of FGE.19 in the Flavouring Group Evaluation 226 (FGE.226). The flavour industry provided genotoxicity studies for the substance 4,5-epoxydec-2(trans)-enal [FL-no: 16.071]. Based on these data, the Panel concluded in FGE.226 that 4,5-epoxydec-2(trans)-enal did not induce gene mutations in bacterial cells but was positive in an in vitro micronucleus assay, so, 4,5-epoxydec-2(trans)-enal is considered an in vitro genotoxic agent. The negative results obtained in an in vivo micronucleus assay cannot overrule the positive results of the in vitro micronucleus assay with and without S9-mix due to the lack of demonstration of bone marrow exposure. Following this, the flavour industry has provided plasma analysis of a satellite group of rats treated with 4,5-epoxydec-2(trans)-enal in order to investigate the systemic exposure of animals in the in vivo micronucleus assay. However, the plasma analysis did not provide enough evidence of target tissue exposure. An in vivo Comet assay in rodents was recommended in FGE.226, in order to investigate possible genotoxic effects at the first site of contact (e.g. stomach/duodenum cells) and in the liver. An in vivo Comet assay in liver and duodenum was provided that suggests that 4,5-epoxydec-2(trans)-enal [FL-no: 16.071] did not induce DNA damage in the duodenum of rats. However, the genotoxic effect observed in vitro was confirmed in the in vivo Comet assay in the liver of rats. The Panel concluded that 4,5-epoxydec-2(trans)-enal [FL-no: 16.071] does raise a safety concern with respect to genotoxicity and, therefore, it cannot be evaluated according to the Procedure.

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KW - FGE.19

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SN - 1831-4732

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