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Scientific Opinion on Flavouring Group Evaluation 67, Revision 3 (FGE.67Rev3): consideration of 23 furan‐substituted compounds evaluated by JECFA at the 55th, 65th, 69th and 86th meetings

The Panel on Food Additives and Flavourings (FAF) was requested to consider the JECFA evaluations of 25 flavouring substances assigned to the Flavouring Group Evaluation 67 (FGE.67Rev3), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Eleven substances have already be...

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Autores principales: Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Engel, Karl‐Heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wölfle, Detlef, Wright, Matthew, Benigni, Romualdo, Bolognesi, Claudia, Chipman, Kevin, Cordelli, Eugenia, Degen, Gisela, Marzin, Daniel, Svendsen, Camilla, Carfì, Maria, Vianello, Giorgia, Mennes, Wim
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7856567/
https://www.ncbi.nlm.nih.gov/pubmed/33552300
http://dx.doi.org/10.2903/j.efsa.2021.6362
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author Younes, Maged
Aquilina, Gabriele
Castle, Laurence
Engel, Karl‐Heinz
Fowler, Paul
Frutos Fernandez, Maria Jose
Fürst, Peter
Gundert‐Remy, Ursula
Gürtler, Rainer
Husøy, Trine
Manco, Melania
Moldeus, Peter
Passamonti, Sabina
Shah, Romina
Waalkens‐Berendsen, Ine
Wölfle, Detlef
Wright, Matthew
Benigni, Romualdo
Bolognesi, Claudia
Chipman, Kevin
Cordelli, Eugenia
Degen, Gisela
Marzin, Daniel
Svendsen, Camilla
Carfì, Maria
Vianello, Giorgia
Mennes, Wim
author_facet Younes, Maged
Aquilina, Gabriele
Castle, Laurence
Engel, Karl‐Heinz
Fowler, Paul
Frutos Fernandez, Maria Jose
Fürst, Peter
Gundert‐Remy, Ursula
Gürtler, Rainer
Husøy, Trine
Manco, Melania
Moldeus, Peter
Passamonti, Sabina
Shah, Romina
Waalkens‐Berendsen, Ine
Wölfle, Detlef
Wright, Matthew
Benigni, Romualdo
Bolognesi, Claudia
Chipman, Kevin
Cordelli, Eugenia
Degen, Gisela
Marzin, Daniel
Svendsen, Camilla
Carfì, Maria
Vianello, Giorgia
Mennes, Wim
collection PubMed
description The Panel on Food Additives and Flavourings (FAF) was requested to consider the JECFA evaluations of 25 flavouring substances assigned to the Flavouring Group Evaluation 67 (FGE.67Rev3), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Eleven substances have already been considered in FGE.67 and its revisions (FGE.67Rev1 and FGE.67Rev2). During the current assessment, two substances were no longer supported by industry, therefore 12 candidate substances are evaluated in FGE.67Rev3. New genotoxicity and toxicity data are available for 2‐pentylfuran [FL‐no: 13.059] and 2‐acetylfuran [FL‐no: 13.054], which are representative substances of subgroup IV [FL‐no: 13.069, 13.106, 13.148] and VI‐B [FL‐no: 13.045, 13.070, 13.083, 13.101, 13.105, 13.138, 13.163], respectively. Based on these data, the Panel concluded that the concern for genotoxicity is ruled out for both [FL‐no: 13.054] and [FL‐no: 13.059] and consequently for the substances that they represent. Since the candidate substances cannot be anticipated to be metabolised to innocuous products only, they were evaluated along the B‐side of the Procedure. The Panel derived a NOAEL of 22.6 mg/kg bw per day and a BMDL of 8.51 mg/kg bw per day, for 2‐acetylfuran and 2‐pentylfuran, respectively. For all 12 substances sufficient margins of safety were calculated when based on the MSDI approach. Adequate specifications for the materials of commerce are available for all 23 flavouring substances. The Panel agrees with JECFA conclusions, for all 23 substances, ‘No safety concern at estimated levels of intake as flavouring substances’ based on the MSDI approach. For 18 substances [FL‐no: 13.021, 13.022, 13.023, 13.024, 13.031, 13.045, 13.047, 13.054, 13.059, 13.074, 13.083, 13.101, 13.105, 13.106, 13.138, 13.148, 13.163 and 13.190], the mTAMDI intake estimates are above the threshold of toxicological concern (TTC) for their structural classes and more reliable data on uses and use levels are required to finalise their evaluation.
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spelling pubmed-78565672021-02-05 Scientific Opinion on Flavouring Group Evaluation 67, Revision 3 (FGE.67Rev3): consideration of 23 furan‐substituted compounds evaluated by JECFA at the 55th, 65th, 69th and 86th meetings Younes, Maged Aquilina, Gabriele Castle, Laurence Engel, Karl‐Heinz Fowler, Paul Frutos Fernandez, Maria Jose Fürst, Peter Gundert‐Remy, Ursula Gürtler, Rainer Husøy, Trine Manco, Melania Moldeus, Peter Passamonti, Sabina Shah, Romina Waalkens‐Berendsen, Ine Wölfle, Detlef Wright, Matthew Benigni, Romualdo Bolognesi, Claudia Chipman, Kevin Cordelli, Eugenia Degen, Gisela Marzin, Daniel Svendsen, Camilla Carfì, Maria Vianello, Giorgia Mennes, Wim EFSA J Scientific Opinion The Panel on Food Additives and Flavourings (FAF) was requested to consider the JECFA evaluations of 25 flavouring substances assigned to the Flavouring Group Evaluation 67 (FGE.67Rev3), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Eleven substances have already been considered in FGE.67 and its revisions (FGE.67Rev1 and FGE.67Rev2). During the current assessment, two substances were no longer supported by industry, therefore 12 candidate substances are evaluated in FGE.67Rev3. New genotoxicity and toxicity data are available for 2‐pentylfuran [FL‐no: 13.059] and 2‐acetylfuran [FL‐no: 13.054], which are representative substances of subgroup IV [FL‐no: 13.069, 13.106, 13.148] and VI‐B [FL‐no: 13.045, 13.070, 13.083, 13.101, 13.105, 13.138, 13.163], respectively. Based on these data, the Panel concluded that the concern for genotoxicity is ruled out for both [FL‐no: 13.054] and [FL‐no: 13.059] and consequently for the substances that they represent. Since the candidate substances cannot be anticipated to be metabolised to innocuous products only, they were evaluated along the B‐side of the Procedure. The Panel derived a NOAEL of 22.6 mg/kg bw per day and a BMDL of 8.51 mg/kg bw per day, for 2‐acetylfuran and 2‐pentylfuran, respectively. For all 12 substances sufficient margins of safety were calculated when based on the MSDI approach. Adequate specifications for the materials of commerce are available for all 23 flavouring substances. The Panel agrees with JECFA conclusions, for all 23 substances, ‘No safety concern at estimated levels of intake as flavouring substances’ based on the MSDI approach. For 18 substances [FL‐no: 13.021, 13.022, 13.023, 13.024, 13.031, 13.045, 13.047, 13.054, 13.059, 13.074, 13.083, 13.101, 13.105, 13.106, 13.138, 13.148, 13.163 and 13.190], the mTAMDI intake estimates are above the threshold of toxicological concern (TTC) for their structural classes and more reliable data on uses and use levels are required to finalise their evaluation. John Wiley and Sons Inc. 2021-02-03 /pmc/articles/PMC7856567/ /pubmed/33552300 http://dx.doi.org/10.2903/j.efsa.2021.6362 Text en © 2021 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 http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
spellingShingle Scientific Opinion
Younes, Maged
Aquilina, Gabriele
Castle, Laurence
Engel, Karl‐Heinz
Fowler, Paul
Frutos Fernandez, Maria Jose
Fürst, Peter
Gundert‐Remy, Ursula
Gürtler, Rainer
Husøy, Trine
Manco, Melania
Moldeus, Peter
Passamonti, Sabina
Shah, Romina
Waalkens‐Berendsen, Ine
Wölfle, Detlef
Wright, Matthew
Benigni, Romualdo
Bolognesi, Claudia
Chipman, Kevin
Cordelli, Eugenia
Degen, Gisela
Marzin, Daniel
Svendsen, Camilla
Carfì, Maria
Vianello, Giorgia
Mennes, Wim
Scientific Opinion on Flavouring Group Evaluation 67, Revision 3 (FGE.67Rev3): consideration of 23 furan‐substituted compounds evaluated by JECFA at the 55th, 65th, 69th and 86th meetings
title Scientific Opinion on Flavouring Group Evaluation 67, Revision 3 (FGE.67Rev3): consideration of 23 furan‐substituted compounds evaluated by JECFA at the 55th, 65th, 69th and 86th meetings
title_full Scientific Opinion on Flavouring Group Evaluation 67, Revision 3 (FGE.67Rev3): consideration of 23 furan‐substituted compounds evaluated by JECFA at the 55th, 65th, 69th and 86th meetings
title_fullStr Scientific Opinion on Flavouring Group Evaluation 67, Revision 3 (FGE.67Rev3): consideration of 23 furan‐substituted compounds evaluated by JECFA at the 55th, 65th, 69th and 86th meetings
title_full_unstemmed Scientific Opinion on Flavouring Group Evaluation 67, Revision 3 (FGE.67Rev3): consideration of 23 furan‐substituted compounds evaluated by JECFA at the 55th, 65th, 69th and 86th meetings
title_short Scientific Opinion on Flavouring Group Evaluation 67, Revision 3 (FGE.67Rev3): consideration of 23 furan‐substituted compounds evaluated by JECFA at the 55th, 65th, 69th and 86th meetings
title_sort scientific opinion on flavouring group evaluation 67, revision 3 (fge.67rev3): consideration of 23 furan‐substituted compounds evaluated by jecfa at the 55th, 65th, 69th and 86th meetings
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7856567/
https://www.ncbi.nlm.nih.gov/pubmed/33552300
http://dx.doi.org/10.2903/j.efsa.2021.6362
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