Scientific Opinion on Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2): 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

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; Mona-Lise Binderup; Francesca Marcon; Daniel Marzin; Pasquale Mosesso; Maria Anastassiadou; Maria Carfì; Siiri Saarma; Rainer Gürtler

doi:10.2903/j.efsa.2017.4766

Scientific Opinion on Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2): 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

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 ZugravuMona-Lise Binderup, Francesca Marcon, Daniel Marzin, Pasquale Mosesso, Maria Anastassiadou, Maria Carfì, Siiri Saarma, Rainer Gürtler

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Abstract

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2). In FGE.208Rev1, the CEF Panel evaluated genotoxicity studies on p-mentha-1,8-dien-7-al [FL-no: 05.117], the representative substance for FGE.19 subgroup 2.2. The Comet assay performed in liver showed a positive result, and therefore, the Panel concluded that p-mentha-1,8-dien-7-al [FL-no: 05.117] is genotoxic in vivo and that, accordingly, there is a safety concern for its use as flavouring substance. Since p-mentha-1,8-dien-7-al [FL-no: 05.117] is representative for the nine remaining substances of subgroup 2.2 (p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], myrtenal [FL-no: 05.106], 2,6,6-trimethyl-1-cyclohexen-1-carboxaldehyde [FL-no: 05.121], myrtenyl formate [FL-no: 09.272], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278], myrtenyl acetate [FL-no: 09.302], myrtenyl-2-methylbutyrate [FL-no: 09.899] and myrtenyl-3-methylbutyrate [FL-no: 09.900]), the Panel concluded in the previous revision of FGE.208 (FGE.208Rev1) that there is a potential safety concern for these substances. Subsequently, the industry has submitted genotoxicity studies on five substances of FGE.19 subgroup 2.2: p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], myrtenal [FL-no: 05.106], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278] and myrtenyl acetate [FL-no: 09.302], which are evaluated in the present revision of FGE.208 (FGE.208Rev2). The Panel concluded that the concern for genotoxicity could be ruled out for p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278] and myrtenyl acetate [FL-no: 09.302], which will be evaluated through the Procedure. Genotoxicity data on myrtenal [FL-no: 05.106] were considered equivocal, therefore, it cannot be evaluated through the Procedure, presently. p-Mentha-1,8-dien-7-al [FL-no: 05.117] and four substances not supported by industry (2,6,6-trimethyl-1-cyclohexen-1-carboxaldehyde [FL-no: 05.121], myrtenyl formate [FL-no: 09.272], myrtenyl-2-methylbutyrate [FL-no: 09.899] and myrtenyl-3-methylbutyrate [FL-no: 09.900]) have been deleted from the Union List.

Original language	English
Pages	e04766
Volume	15
No.	5
Specialist publication	EFSA Journal
Publisher	European Food Safety Authority (EFSA)
DOIs	https://doi.org/10.2903/j.efsa.2017.4766
Publication status	Published - May 2017

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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Scientific Opinion on Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2): 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
© 2017 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/
Final published version, 3.07 MBLicence: CC BY-ND

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EFSA Panel on Food Contact Materials Enzymes, F. A. P. A., 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, M. R., Penninks, A., Smith, A., de Fátima Tavares Poças, M., Tlustos, C., Wölfle, D., Zorn, H., ... Gürtler, R. (2017). Scientific Opinion on Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2): 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, 15(5), e04766. https://doi.org/10.2903/j.efsa.2017.4766

Scientific Opinion on Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2): 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 Panel on Food Contact Materials Enzymes, Flavourings and Processing Aids (CEF); Silano, Vittorio; Bolognesi, Claudia et al.
In: EFSA Journal, Vol. 15, No. 5, 05.2017, p. e04766.

Research output: Contribution to specialist publication › Article

EFSA Panel on Food Contact Materials Enzymes, FAPA, 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, de Fátima Tavares Poças, M, Tlustos, C, Wölfle, D, Zorn, H, Zugravu, C-A, Binderup, M-L, Marcon, F, Marzin, D, Mosesso, P, Anastassiadou, M, Carfì, M, Saarma, S & Gürtler, R 2017, 'Scientific Opinion on Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2): 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. 15, no. 5, pp. e04766. https://doi.org/10.2903/j.efsa.2017.4766

EFSA Panel on Food Contact Materials Enzymes FAPA, Silano V, Bolognesi C, Castle L, Cravedi JP, Engel KH et al. Scientific Opinion on Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2): 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. 2017 May;15(5):e04766. Epub 2017 May 17. doi: 10.2903/j.efsa.2017.4766

EFSA Panel on Food Contact Materials Enzymes, Flavourings and Processing Aids (CEF) ; Silano, Vittorio ; Bolognesi, Claudia et al. / Scientific Opinion on Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2): 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. In: EFSA Journal. 2017 ; Vol. 15, No. 5. pp. e04766.

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title = "Scientific Opinion on Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2): 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 Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2). In FGE.208Rev1, the CEF Panel evaluated genotoxicity studies on p-mentha-1,8-dien-7-al [FL-no: 05.117], the representative substance for FGE.19 subgroup 2.2. The Comet assay performed in liver showed a positive result, and therefore, the Panel concluded that p-mentha-1,8-dien-7-al [FL-no: 05.117] is genotoxic in vivo and that, accordingly, there is a safety concern for its use as flavouring substance. Since p-mentha-1,8-dien-7-al [FL-no: 05.117] is representative for the nine remaining substances of subgroup 2.2 (p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], myrtenal [FL-no: 05.106], 2,6,6-trimethyl-1-cyclohexen-1-carboxaldehyde [FL-no: 05.121], myrtenyl formate [FL-no: 09.272], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278], myrtenyl acetate [FL-no: 09.302], myrtenyl-2-methylbutyrate [FL-no: 09.899] and myrtenyl-3-methylbutyrate [FL-no: 09.900]), the Panel concluded in the previous revision of FGE.208 (FGE.208Rev1) that there is a potential safety concern for these substances. Subsequently, the industry has submitted genotoxicity studies on five substances of FGE.19 subgroup 2.2: p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], myrtenal [FL-no: 05.106], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278] and myrtenyl acetate [FL-no: 09.302], which are evaluated in the present revision of FGE.208 (FGE.208Rev2). The Panel concluded that the concern for genotoxicity could be ruled out for p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278] and myrtenyl acetate [FL-no: 09.302], which will be evaluated through the Procedure. Genotoxicity data on myrtenal [FL-no: 05.106] were considered equivocal, therefore, it cannot be evaluated through the Procedure, presently. p-Mentha-1,8-dien-7-al [FL-no: 05.117] and four substances not supported by industry (2,6,6-trimethyl-1-cyclohexen-1-carboxaldehyde [FL-no: 05.121], myrtenyl formate [FL-no: 09.272], myrtenyl-2-methylbutyrate [FL-no: 09.899] and myrtenyl-3-methylbutyrate [FL-no: 09.900]) have been deleted from the Union List.",

keywords = "FGE.19, subgroup 2.2, alicyclic aldehydes, α,β-unsaturated",

author = "{EFSA Panel on Food Contact Materials Enzymes}, {Flavourings and Processing Aids (CEF)} and Vittorio Silano and Claudia Bolognesi and Laurence Castle 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 Andr{\'e} Penninks and Andrew Smith and {de F{\'a}tima Tavares Po{\c c}as}, Maria and Christina Tlustos and Detlef W{\"o}lfle and Holger Zorn and Corina-Aurelia Zugravu and Mona-Lise Binderup and Francesca Marcon and Daniel Marzin and Pasquale Mosesso and Maria Anastassiadou and Maria Carf{\`i} and Siiri Saarma and Rainer G{\"u}rtler",

year = "2017",

month = may,

doi = "10.2903/j.efsa.2017.4766",

language = "English",

volume = "15",

pages = "e04766",

journal = "EFSA Journal",

issn = "1831-4732",

publisher = "European Food Safety Authority (EFSA)",

}

TY - GEN

T1 - Scientific Opinion on Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2): 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

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

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

AU - Mennes, Wim

AU - Milana, Maria Rosaria

AU - Penninks, André

AU - Smith, Andrew

AU - de Fátima Tavares Poças, Maria

AU - Tlustos, Christina

AU - Wölfle, Detlef

AU - Zorn, Holger

AU - Zugravu, Corina-Aurelia

AU - Binderup, Mona-Lise

AU - Marcon, Francesca

AU - Marzin, Daniel

AU - Mosesso, Pasquale

AU - Anastassiadou, Maria

AU - Carfì, Maria

AU - Saarma, Siiri

AU - Gürtler, Rainer

PY - 2017/5

Y1 - 2017/5

N2 - The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2). In FGE.208Rev1, the CEF Panel evaluated genotoxicity studies on p-mentha-1,8-dien-7-al [FL-no: 05.117], the representative substance for FGE.19 subgroup 2.2. The Comet assay performed in liver showed a positive result, and therefore, the Panel concluded that p-mentha-1,8-dien-7-al [FL-no: 05.117] is genotoxic in vivo and that, accordingly, there is a safety concern for its use as flavouring substance. Since p-mentha-1,8-dien-7-al [FL-no: 05.117] is representative for the nine remaining substances of subgroup 2.2 (p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], myrtenal [FL-no: 05.106], 2,6,6-trimethyl-1-cyclohexen-1-carboxaldehyde [FL-no: 05.121], myrtenyl formate [FL-no: 09.272], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278], myrtenyl acetate [FL-no: 09.302], myrtenyl-2-methylbutyrate [FL-no: 09.899] and myrtenyl-3-methylbutyrate [FL-no: 09.900]), the Panel concluded in the previous revision of FGE.208 (FGE.208Rev1) that there is a potential safety concern for these substances. Subsequently, the industry has submitted genotoxicity studies on five substances of FGE.19 subgroup 2.2: p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], myrtenal [FL-no: 05.106], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278] and myrtenyl acetate [FL-no: 09.302], which are evaluated in the present revision of FGE.208 (FGE.208Rev2). The Panel concluded that the concern for genotoxicity could be ruled out for p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278] and myrtenyl acetate [FL-no: 09.302], which will be evaluated through the Procedure. Genotoxicity data on myrtenal [FL-no: 05.106] were considered equivocal, therefore, it cannot be evaluated through the Procedure, presently. p-Mentha-1,8-dien-7-al [FL-no: 05.117] and four substances not supported by industry (2,6,6-trimethyl-1-cyclohexen-1-carboxaldehyde [FL-no: 05.121], myrtenyl formate [FL-no: 09.272], myrtenyl-2-methylbutyrate [FL-no: 09.899] and myrtenyl-3-methylbutyrate [FL-no: 09.900]) have been deleted from the Union List.

AB - The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2). In FGE.208Rev1, the CEF Panel evaluated genotoxicity studies on p-mentha-1,8-dien-7-al [FL-no: 05.117], the representative substance for FGE.19 subgroup 2.2. The Comet assay performed in liver showed a positive result, and therefore, the Panel concluded that p-mentha-1,8-dien-7-al [FL-no: 05.117] is genotoxic in vivo and that, accordingly, there is a safety concern for its use as flavouring substance. Since p-mentha-1,8-dien-7-al [FL-no: 05.117] is representative for the nine remaining substances of subgroup 2.2 (p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], myrtenal [FL-no: 05.106], 2,6,6-trimethyl-1-cyclohexen-1-carboxaldehyde [FL-no: 05.121], myrtenyl formate [FL-no: 09.272], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278], myrtenyl acetate [FL-no: 09.302], myrtenyl-2-methylbutyrate [FL-no: 09.899] and myrtenyl-3-methylbutyrate [FL-no: 09.900]), the Panel concluded in the previous revision of FGE.208 (FGE.208Rev1) that there is a potential safety concern for these substances. Subsequently, the industry has submitted genotoxicity studies on five substances of FGE.19 subgroup 2.2: p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], myrtenal [FL-no: 05.106], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278] and myrtenyl acetate [FL-no: 09.302], which are evaluated in the present revision of FGE.208 (FGE.208Rev2). The Panel concluded that the concern for genotoxicity could be ruled out for p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278] and myrtenyl acetate [FL-no: 09.302], which will be evaluated through the Procedure. Genotoxicity data on myrtenal [FL-no: 05.106] were considered equivocal, therefore, it cannot be evaluated through the Procedure, presently. p-Mentha-1,8-dien-7-al [FL-no: 05.117] and four substances not supported by industry (2,6,6-trimethyl-1-cyclohexen-1-carboxaldehyde [FL-no: 05.121], myrtenyl formate [FL-no: 09.272], myrtenyl-2-methylbutyrate [FL-no: 09.899] and myrtenyl-3-methylbutyrate [FL-no: 09.900]) have been deleted from the Union List.

KW - FGE.19

KW - subgroup 2.2

KW - alicyclic aldehydes

KW - α,β-unsaturated

U2 - 10.2903/j.efsa.2017.4766

DO - 10.2903/j.efsa.2017.4766

M3 - Article

SN - 1831-4732

VL - 15

SP - e04766

JO - EFSA Journal

JF - EFSA Journal

PB - European Food Safety Authority (EFSA)

ER -