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Scientific Opinion on Flavouring Group Evaluation 13 Revision 3 (FGE.13Rev3): furfuryl and furan derivatives with and without additional side‐chain substituents and heteroatoms from chemical group 14
The Panel on Food additives and Flavourings of the EFSA was requested to update Flavouring Group Evaluation 13 using the Procedure as outlined in Commission Regulation (EC) No 1565/2000, to include an evaluation of the flavouring substances 2‐ethyl‐5‐methylfuran [FL‐no: 13.125] and 2‐octylfuran [FL‐...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7856902/ https://www.ncbi.nlm.nih.gov/pubmed/33552301 http://dx.doi.org/10.2903/j.efsa.2021.6386 |
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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 of the EFSA was requested to update Flavouring Group Evaluation 13 using the Procedure as outlined in Commission Regulation (EC) No 1565/2000, to include an evaluation of the flavouring substances 2‐ethyl‐5‐methylfuran [FL‐no: 13.125] and 2‐octylfuran [FL‐no: 13.162]. FGE.13 revision 3 (FGE.13Rev3) deals with 26 flavourings substances of which 24 have been already evaluated to be of no safety concern. For [FL‐no: 13.125] and [FL‐no: 13.162], a concern for genotoxicity was raised in FGE.13Rev1. This concern could be ruled out based on new genotoxicity data on supporting substances in FGE.67Rev3. Subsequently, [FL‐no: 13.125 and 13.162] were evaluated, through a stepwise approach that integrates intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity, along the B‐side of the Procedure, making use of a BMDL of 8.51 mg/kg body weight (bw) per day. The Panel derived this BMDL from an oral subchronic toxicity study with the supporting substance 2‐pentylfuran [FL‐no: 13.059]. Using this BMDL, for [FL‐no: 13.125 and 13.162], adequate margins of safety were calculated based on the MSDI approach. The Panel concluded that the 26 candidate substances in FGE.13Rev3 do not give rise to safety concerns at their levels of dietary intake, when estimated on the basis of the MSDI approach. Adequate specifications for the materials of commerce have been provided for all 26 substances. Data on uses and use levels are needed for [FL‐no: 13.130]. For 21 flavouring substances [FL‐no: 13.011, 13.102, 13.108, 13.113, 13.114, 13.122, 13.125, 13.127, 13.129, 13.132, 13.133, 13.135, 13.136, 13.139, 13.141, 13.143, 13.146, 13.149, 13.162, 13.178 and 13.185], the mTAMDI intake estimates are above the TTC for their structural class and more reliable data on uses and use levels are required to finalise their evaluation. |
format | Online Article Text |
id | pubmed-7856902 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-78569022021-02-05 Scientific Opinion on Flavouring Group Evaluation 13 Revision 3 (FGE.13Rev3): furfuryl and furan derivatives with and without additional side‐chain substituents and heteroatoms from chemical group 14 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 of the EFSA was requested to update Flavouring Group Evaluation 13 using the Procedure as outlined in Commission Regulation (EC) No 1565/2000, to include an evaluation of the flavouring substances 2‐ethyl‐5‐methylfuran [FL‐no: 13.125] and 2‐octylfuran [FL‐no: 13.162]. FGE.13 revision 3 (FGE.13Rev3) deals with 26 flavourings substances of which 24 have been already evaluated to be of no safety concern. For [FL‐no: 13.125] and [FL‐no: 13.162], a concern for genotoxicity was raised in FGE.13Rev1. This concern could be ruled out based on new genotoxicity data on supporting substances in FGE.67Rev3. Subsequently, [FL‐no: 13.125 and 13.162] were evaluated, through a stepwise approach that integrates intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity, along the B‐side of the Procedure, making use of a BMDL of 8.51 mg/kg body weight (bw) per day. The Panel derived this BMDL from an oral subchronic toxicity study with the supporting substance 2‐pentylfuran [FL‐no: 13.059]. Using this BMDL, for [FL‐no: 13.125 and 13.162], adequate margins of safety were calculated based on the MSDI approach. The Panel concluded that the 26 candidate substances in FGE.13Rev3 do not give rise to safety concerns at their levels of dietary intake, when estimated on the basis of the MSDI approach. Adequate specifications for the materials of commerce have been provided for all 26 substances. Data on uses and use levels are needed for [FL‐no: 13.130]. For 21 flavouring substances [FL‐no: 13.011, 13.102, 13.108, 13.113, 13.114, 13.122, 13.125, 13.127, 13.129, 13.132, 13.133, 13.135, 13.136, 13.139, 13.141, 13.143, 13.146, 13.149, 13.162, 13.178 and 13.185], the mTAMDI intake estimates are above the TTC for their structural class 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/PMC7856902/ /pubmed/33552301 http://dx.doi.org/10.2903/j.efsa.2021.6386 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 13 Revision 3 (FGE.13Rev3): furfuryl and furan derivatives with and without additional side‐chain substituents and heteroatoms from chemical group 14 |
title | Scientific Opinion on Flavouring Group Evaluation 13 Revision 3 (FGE.13Rev3): furfuryl and furan derivatives with and without additional side‐chain substituents and heteroatoms from chemical group 14 |
title_full | Scientific Opinion on Flavouring Group Evaluation 13 Revision 3 (FGE.13Rev3): furfuryl and furan derivatives with and without additional side‐chain substituents and heteroatoms from chemical group 14 |
title_fullStr | Scientific Opinion on Flavouring Group Evaluation 13 Revision 3 (FGE.13Rev3): furfuryl and furan derivatives with and without additional side‐chain substituents and heteroatoms from chemical group 14 |
title_full_unstemmed | Scientific Opinion on Flavouring Group Evaluation 13 Revision 3 (FGE.13Rev3): furfuryl and furan derivatives with and without additional side‐chain substituents and heteroatoms from chemical group 14 |
title_short | Scientific Opinion on Flavouring Group Evaluation 13 Revision 3 (FGE.13Rev3): furfuryl and furan derivatives with and without additional side‐chain substituents and heteroatoms from chemical group 14 |
title_sort | scientific opinion on flavouring group evaluation 13 revision 3 (fge.13rev3): furfuryl and furan derivatives with and without additional side‐chain substituents and heteroatoms from chemical group 14 |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7856902/ https://www.ncbi.nlm.nih.gov/pubmed/33552301 http://dx.doi.org/10.2903/j.efsa.2021.6386 |
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