Scientific Opinion on Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3): Consideration of genotoxic potential for α,β-unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 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.2019.5676

Scientific Opinion on Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3): Consideration of genotoxic potential for α,β-unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 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)

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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 5 flavouring substances in Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3). In FGE.210, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the genotoxic potential could not be ruled out for any of the flavouring substances. In FGE.210Rev1, the concern for genotoxic potential has been ruled out for eight substances [FL-no: 02.105, 07.007, 07.009, 07.011, 07.036, 07.088, 07.091 and 07.170]. In FGE.210 Rev2, the concern for genotoxic potential has been ruled out for allyl α-ionone [FL-no: 07.061]. In the present revision of FGE 210 (FGE.210Rev3), additional in vitro and in vivo data on the representative substance α-damascone [FL-no: 07.134] are evaluated. To investigate equivocal and positive results observed in in vitro micronucleus studies, an in vivo combined micronucleus (bone marrow) and comet assay (liver and duodenum) was performed. α-Damascone did not induce micronuclei in bone marrow and no primary DNA damage in duodenum; however, an increase in primary DNA damage was observed in liver. This positive result was attributed by the applicant to a high level of peroxides in the sample tested. Therefore, the comet assay was repeated with a new sample of α-damascone, confirming the negative results observed in duodenum, but equivocal results were observed in liver. Two additional in vivo comet assays in liver were performed in order to clarify the potential impact of peroxides on the obtained results from the genotoxicity testing. However, the materials studied in these tests were not suitable to establish the potential role of peroxides in the genotoxicity of α-damascone. The Panel concluded that the concern for genotoxicity cannot be ruled out for α-damascone [FL-no: 07.134] and the four structurally related substances [FL-no: 07.130, 07.225, 07.226 and 07.231].

Original language	English
Pages	e05676
Number of pages	42
Volume	17
No.	5
Specialist publication	EFSA Journal
DOIs	https://doi.org/10.2903/j.efsa.2019.5676
Publication status	Published - May 2019

Keywords

α
β-unsaturated alicyclic ketones
flavouring substances
safety evaluation
FGE.210
subgroup 2.4
FGE.19

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 210 Revision 3 (FGE.210Rev3): Consideration of genotoxic potential for α,β-unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 of FGE.19. EFSA Journal, 17(5), e05676. https://doi.org/10.2903/j.efsa.2019.5676

Scientific Opinion on Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3) : Consideration of genotoxic potential for α,β-unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 of FGE.19. / Younes, Maged; Aquilina, Gabriele; Castle, Laurence et al.

In: EFSA Journal, Vol. 17, No. 5, 05.2019, p. e05676.

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 210 Revision 3 (FGE.210Rev3): Consideration of genotoxic potential for α,β-unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 of FGE.19' EFSA Journal, vol. 17, no. 5, pp. e05676. https://doi.org/10.2903/j.efsa.2019.5676

Younes M, Aquilina G, Castle L, Engel K-H, Fowler P, Frutos Fernandez MJ et al. Scientific Opinion on Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3): Consideration of genotoxic potential for α,β-unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 of FGE.19. EFSA Journal. 2019 May;17(5):e05676. Epub 2019 May 22. doi: 10.2903/j.efsa.2019.5676

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title = "Scientific Opinion on Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3): Consideration of genotoxic potential for α,β-unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 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 5 flavouring substances in Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3). In FGE.210, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the genotoxic potential could not be ruled out for any of the flavouring substances. In FGE.210Rev1, the concern for genotoxic potential has been ruled out for eight substances [FL-no: 02.105, 07.007, 07.009, 07.011, 07.036, 07.088, 07.091 and 07.170]. In FGE.210 Rev2, the concern for genotoxic potential has been ruled out for allyl α-ionone [FL-no: 07.061]. In the present revision of FGE 210 (FGE.210Rev3), additional in vitro and in vivo data on the representative substance α-damascone [FL-no: 07.134] are evaluated. To investigate equivocal and positive results observed in in vitro micronucleus studies, an in vivo combined micronucleus (bone marrow) and comet assay (liver and duodenum) was performed. α-Damascone did not induce micronuclei in bone marrow and no primary DNA damage in duodenum; however, an increase in primary DNA damage was observed in liver. This positive result was attributed by the applicant to a high level of peroxides in the sample tested. Therefore, the comet assay was repeated with a new sample of α-damascone, confirming the negative results observed in duodenum, but equivocal results were observed in liver. Two additional in vivo comet assays in liver were performed in order to clarify the potential impact of peroxides on the obtained results from the genotoxicity testing. However, the materials studied in these tests were not suitable to establish the potential role of peroxides in the genotoxicity of α-damascone. The Panel concluded that the concern for genotoxicity cannot be ruled out for α-damascone [FL-no: 07.134] and the four structurally related substances [FL-no: 07.130, 07.225, 07.226 and 07.231].",

keywords = "α, β-unsaturated alicyclic ketones, flavouring substances, safety evaluation, FGE.210, subgroup 2.4, 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 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 for the support provided to this scientific output.",

year = "2019",

month = may,

doi = "10.2903/j.efsa.2019.5676",

language = "English",

volume = "17",

pages = "e05676",

journal = "EFSA Journal",

issn = "1831-4732",

publisher = "John Wiley & Sons, Ltd",

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T1 - Scientific Opinion on Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3)

T2 - Consideration of genotoxic potential for α,β-unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 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 for the support provided to this scientific output.

PY - 2019/5

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N2 - The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 5 flavouring substances in Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3). In FGE.210, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the genotoxic potential could not be ruled out for any of the flavouring substances. In FGE.210Rev1, the concern for genotoxic potential has been ruled out for eight substances [FL-no: 02.105, 07.007, 07.009, 07.011, 07.036, 07.088, 07.091 and 07.170]. In FGE.210 Rev2, the concern for genotoxic potential has been ruled out for allyl α-ionone [FL-no: 07.061]. In the present revision of FGE 210 (FGE.210Rev3), additional in vitro and in vivo data on the representative substance α-damascone [FL-no: 07.134] are evaluated. To investigate equivocal and positive results observed in in vitro micronucleus studies, an in vivo combined micronucleus (bone marrow) and comet assay (liver and duodenum) was performed. α-Damascone did not induce micronuclei in bone marrow and no primary DNA damage in duodenum; however, an increase in primary DNA damage was observed in liver. This positive result was attributed by the applicant to a high level of peroxides in the sample tested. Therefore, the comet assay was repeated with a new sample of α-damascone, confirming the negative results observed in duodenum, but equivocal results were observed in liver. Two additional in vivo comet assays in liver were performed in order to clarify the potential impact of peroxides on the obtained results from the genotoxicity testing. However, the materials studied in these tests were not suitable to establish the potential role of peroxides in the genotoxicity of α-damascone. The Panel concluded that the concern for genotoxicity cannot be ruled out for α-damascone [FL-no: 07.134] and the four structurally related substances [FL-no: 07.130, 07.225, 07.226 and 07.231].

AB - The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 5 flavouring substances in Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3). In FGE.210, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the genotoxic potential could not be ruled out for any of the flavouring substances. In FGE.210Rev1, the concern for genotoxic potential has been ruled out for eight substances [FL-no: 02.105, 07.007, 07.009, 07.011, 07.036, 07.088, 07.091 and 07.170]. In FGE.210 Rev2, the concern for genotoxic potential has been ruled out for allyl α-ionone [FL-no: 07.061]. In the present revision of FGE 210 (FGE.210Rev3), additional in vitro and in vivo data on the representative substance α-damascone [FL-no: 07.134] are evaluated. To investigate equivocal and positive results observed in in vitro micronucleus studies, an in vivo combined micronucleus (bone marrow) and comet assay (liver and duodenum) was performed. α-Damascone did not induce micronuclei in bone marrow and no primary DNA damage in duodenum; however, an increase in primary DNA damage was observed in liver. This positive result was attributed by the applicant to a high level of peroxides in the sample tested. Therefore, the comet assay was repeated with a new sample of α-damascone, confirming the negative results observed in duodenum, but equivocal results were observed in liver. Two additional in vivo comet assays in liver were performed in order to clarify the potential impact of peroxides on the obtained results from the genotoxicity testing. However, the materials studied in these tests were not suitable to establish the potential role of peroxides in the genotoxicity of α-damascone. The Panel concluded that the concern for genotoxicity cannot be ruled out for α-damascone [FL-no: 07.134] and the four structurally related substances [FL-no: 07.130, 07.225, 07.226 and 07.231].

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KW - β-unsaturated alicyclic ketones

KW - flavouring substances

KW - safety evaluation

KW - FGE.210

KW - subgroup 2.4

KW - FGE.19

U2 - 10.2903/j.efsa.2019.5676

DO - 10.2903/j.efsa.2019.5676

M3 - Article

VL - 17

SP - e05676

JO - EFSA Journal

JF - EFSA Journal

SN - 1831-4732

ER -