Scientific Opinion on Flavouring Group Evaluation 73, Revision 5 (FGE.73Rev5): consideration of alicyclic alcohols, aldehydes, acids and related esters evaluated by JECFA (59th, 63rd and 86th meeting) and structurally related to substances evaluated in FGE.12Rev5

EFSA Panel on Food Additives and Flavourings (FAF); 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; Carla Martino; Wim Mennes

doi:10.2903/j.efsa.2020.5970

Scientific Opinion on Flavouring Group Evaluation 73, Revision 5 (FGE.73Rev5): consideration of alicyclic alcohols, aldehydes, acids and related esters evaluated by JECFA (59th, 63rd and 86th meeting) and structurally related to substances evaluated in FGE.12Rev5

EFSA Panel on Food Additives and Flavourings (FAF)
, 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, Carla Martino, Wim Mennes

Research output: Contribution to specialist publication › Article

1 Citation (Scopus)

12 Downloads (Pure)

Abstract

The EFSA Panel on Food Additives and Flavourings was requested to evaluate 24 flavouring substances assigned to the Flavouring Group Evaluation 73 (FGE.73), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Twenty-three substances have already been considered in FGE.73 and its four revisions ([FL-no: 02.114, 02.141, 05.098, 05.112, 08.067, 09.289, 09.488, 09.534, 09.615, 05.119, 05.123, 08.034, 08.060, 09.028, 09.536, 05.104, 09.034, 09.712, 09.305, 02.060, 02.091, 09.278, 09.302]). The remaining substance myrtenal [FL-no: 05.106] has been cleared with respect to genotoxicity in FGE.208Rev3 and is considered in this revision 5 of FGE.73. The substances were evaluated through a stepwise approach that integrates information on the structure?activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of these 24 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the ?Maximised Survey-derived Daily Intake? (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate for 23 substances. For [FL-no: 09.278], the stereoisomeric composition is not specified. For two substances [FL-no: 09.034, and 09.712], the modified Theoretical Added Maximum Daily Intake (mTAMDI) estimates are above the TTC for their structural class (I). For 17 substances evaluated through the Procedure, no normal and maximum use levels are available. Therefore, for these 19 substances, more detailed data on uses and use levels should be provided in order to refine their exposure assessments and to finalise their safety evaluations.

Original language	English
Number of pages	31
Volume	18
No.	1
Specialist publication	EFSA Journal
DOIs	https://doi.org/10.2903/j.efsa.2020.5970
Publication status	Published - 31 Jan 2020

Bibliographical note

Acknowledgments: The Panel on Food Additives and Flavourings (FAF) wishes to thank the hearing experts Vibe Beltoft, Karin Nørby and Giorgia Vianello for the support provided to this scientific output.
Reproduction of the images listed below is prohibited and permission must be sought directly from the copyright holder:
Figure A.2 is reproduced from the 82nd JECFA report, 2016 (http://www.fao.org/3/a-bl839e.pdf, p. 13).
Permission may be sought from the copyright holder (i.e. FAO/WHO/JECFA) for the reproduction of the image, as indicated in the report.
Figure A.2: © FAO/WHO/JECFA

Keywords

Flavourings
Myrtenal
α,β-unsaturated carbonyls
FGE.73 Rev4
JECFA

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© 2020 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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EFSA Panel on Food Additives and Flavourings (FAF), 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., ... Mennes, W. (2020). Scientific Opinion on Flavouring Group Evaluation 73, Revision 5 (FGE.73Rev5): consideration of alicyclic alcohols, aldehydes, acids and related esters evaluated by JECFA (59th, 63rd and 86th meeting) and structurally related to substances evaluated in FGE.12Rev5. EFSA Journal, 18(1). https://doi.org/10.2903/j.efsa.2020.5970

Scientific Opinion on Flavouring Group Evaluation 73, Revision 5 (FGE.73Rev5): consideration of alicyclic alcohols, aldehydes, acids and related esters evaluated by JECFA (59th, 63rd and 86th meeting) and structurally related to substances evaluated in FGE.12Rev5. / EFSA Panel on Food Additives and Flavourings (FAF); Younes, Maged; Aquilina, Gabriele et al.
In: EFSA Journal, Vol. 18, No. 1, 31.01.2020.

Research output: Contribution to specialist publication › Article

EFSA Panel on Food Additives and Flavourings (FAF), 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, Martino, C & Mennes, W 2020, 'Scientific Opinion on Flavouring Group Evaluation 73, Revision 5 (FGE.73Rev5): consideration of alicyclic alcohols, aldehydes, acids and related esters evaluated by JECFA (59th, 63rd and 86th meeting) and structurally related to substances evaluated in FGE.12Rev5' EFSA Journal, vol. 18, no. 1. https://doi.org/10.2903/j.efsa.2020.5970

EFSA Panel on Food Additives and Flavourings (FAF), Younes M, Aquilina G, Castle L, Engel KH, Fowler P et al. Scientific Opinion on Flavouring Group Evaluation 73, Revision 5 (FGE.73Rev5): consideration of alicyclic alcohols, aldehydes, acids and related esters evaluated by JECFA (59th, 63rd and 86th meeting) and structurally related to substances evaluated in FGE.12Rev5. EFSA Journal. 2020 Jan 31;18(1). Epub 2020 Jan 31. doi: 10.2903/j.efsa.2020.5970

EFSA Panel on Food Additives and Flavourings (FAF) ; Younes, Maged ; Aquilina, Gabriele et al. / Scientific Opinion on Flavouring Group Evaluation 73, Revision 5 (FGE.73Rev5) : consideration of alicyclic alcohols, aldehydes, acids and related esters evaluated by JECFA (59th, 63rd and 86th meeting) and structurally related to substances evaluated in FGE.12Rev5. In: EFSA Journal. 2020 ; Vol. 18, No. 1.

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title = "Scientific Opinion on Flavouring Group Evaluation 73, Revision 5 (FGE.73Rev5): consideration of alicyclic alcohols, aldehydes, acids and related esters evaluated by JECFA (59th, 63rd and 86th meeting) and structurally related to substances evaluated in FGE.12Rev5",

abstract = "The EFSA Panel on Food Additives and Flavourings was requested to evaluate 24 flavouring substances assigned to the Flavouring Group Evaluation 73 (FGE.73), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Twenty-three substances have already been considered in FGE.73 and its four revisions ([FL-no: 02.114, 02.141, 05.098, 05.112, 08.067, 09.289, 09.488, 09.534, 09.615, 05.119, 05.123, 08.034, 08.060, 09.028, 09.536, 05.104, 09.034, 09.712, 09.305, 02.060, 02.091, 09.278, 09.302]). The remaining substance myrtenal [FL-no: 05.106] has been cleared with respect to genotoxicity in FGE.208Rev3 and is considered in this revision 5 of FGE.73. The substances were evaluated through a stepwise approach that integrates information on the structure?activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of these 24 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the ?Maximised Survey-derived Daily Intake? (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate for 23 substances. For [FL-no: 09.278], the stereoisomeric composition is not specified. For two substances [FL-no: 09.034, and 09.712], the modified Theoretical Added Maximum Daily Intake (mTAMDI) estimates are above the TTC for their structural class (I). For 17 substances evaluated through the Procedure, no normal and maximum use levels are available. Therefore, for these 19 substances, more detailed data on uses and use levels should be provided in order to refine their exposure assessments and to finalise their safety evaluations.",

keywords = "Flavourings, Myrtenal, α,β-unsaturated carbonyls, FGE.73 Rev4, JECFA",

author = "\{EFSA Panel on Food Additives and Flavourings (FAF)\} and 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 Carla Martino and Wim Mennes",

note = "Acknowledgments: The Panel on Food Additives and Flavourings (FAF) wishes to thank the hearing experts Vibe Beltoft, Karin N{\o}rby and Giorgia Vianello for the support provided to this scientific output. Reproduction of the images listed below is prohibited and permission must be sought directly from the copyright holder: Figure A.2 is reproduced from the 82nd JECFA report, 2016 (http://www.fao.org/3/a-bl839e.pdf, p. 13). Permission may be sought from the copyright holder (i.e. FAO/WHO/JECFA) for the reproduction of the image, as indicated in the report. Figure A.2: {\textcopyright} FAO/WHO/JECFA",

year = "2020",

month = jan,

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doi = "10.2903/j.efsa.2020.5970",

language = "English",

volume = "18",

journal = "EFSA Journal",

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N1 - Acknowledgments: The Panel on Food Additives and Flavourings (FAF) wishes to thank the hearing experts Vibe Beltoft, Karin Nørby and Giorgia Vianello for the support provided to this scientific output. Reproduction of the images listed below is prohibited and permission must be sought directly from the copyright holder: Figure A.2 is reproduced from the 82nd JECFA report, 2016 (http://www.fao.org/3/a-bl839e.pdf, p. 13). Permission may be sought from the copyright holder (i.e. FAO/WHO/JECFA) for the reproduction of the image, as indicated in the report. Figure A.2: © FAO/WHO/JECFA

PY - 2020/1/31

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N2 - The EFSA Panel on Food Additives and Flavourings was requested to evaluate 24 flavouring substances assigned to the Flavouring Group Evaluation 73 (FGE.73), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Twenty-three substances have already been considered in FGE.73 and its four revisions ([FL-no: 02.114, 02.141, 05.098, 05.112, 08.067, 09.289, 09.488, 09.534, 09.615, 05.119, 05.123, 08.034, 08.060, 09.028, 09.536, 05.104, 09.034, 09.712, 09.305, 02.060, 02.091, 09.278, 09.302]). The remaining substance myrtenal [FL-no: 05.106] has been cleared with respect to genotoxicity in FGE.208Rev3 and is considered in this revision 5 of FGE.73. The substances were evaluated through a stepwise approach that integrates information on the structure?activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of these 24 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the ?Maximised Survey-derived Daily Intake? (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate for 23 substances. For [FL-no: 09.278], the stereoisomeric composition is not specified. For two substances [FL-no: 09.034, and 09.712], the modified Theoretical Added Maximum Daily Intake (mTAMDI) estimates are above the TTC for their structural class (I). For 17 substances evaluated through the Procedure, no normal and maximum use levels are available. Therefore, for these 19 substances, more detailed data on uses and use levels should be provided in order to refine their exposure assessments and to finalise their safety evaluations.

AB - The EFSA Panel on Food Additives and Flavourings was requested to evaluate 24 flavouring substances assigned to the Flavouring Group Evaluation 73 (FGE.73), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Twenty-three substances have already been considered in FGE.73 and its four revisions ([FL-no: 02.114, 02.141, 05.098, 05.112, 08.067, 09.289, 09.488, 09.534, 09.615, 05.119, 05.123, 08.034, 08.060, 09.028, 09.536, 05.104, 09.034, 09.712, 09.305, 02.060, 02.091, 09.278, 09.302]). The remaining substance myrtenal [FL-no: 05.106] has been cleared with respect to genotoxicity in FGE.208Rev3 and is considered in this revision 5 of FGE.73. The substances were evaluated through a stepwise approach that integrates information on the structure?activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of these 24 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the ?Maximised Survey-derived Daily Intake? (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate for 23 substances. For [FL-no: 09.278], the stereoisomeric composition is not specified. For two substances [FL-no: 09.034, and 09.712], the modified Theoretical Added Maximum Daily Intake (mTAMDI) estimates are above the TTC for their structural class (I). For 17 substances evaluated through the Procedure, no normal and maximum use levels are available. Therefore, for these 19 substances, more detailed data on uses and use levels should be provided in order to refine their exposure assessments and to finalise their safety evaluations.

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KW - Myrtenal

KW - α,β-unsaturated carbonyls

KW - FGE.73 Rev4

KW - JECFA

U2 - 10.2903/j.efsa.2020.5970

DO - 10.2903/j.efsa.2020.5970

M3 - Article

SN - 1831-4732

VL - 18

JO - EFSA Journal

JF - EFSA Journal

ER -