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Scientific Opinion on Flavouring Group Evaluation 91, Revision 3 (FGE.91Rev3): consideration of aliphatic, aromatic and α,β‐unsaturated sulfides and thiols evaluated by JECFA (53rd, 61st, 68th and 76th meetings), structurally related to substances in FGE.08Rev5

The EFSA Panel on Food Additives and Flavourings was requested to evaluate 49 flavouring substances assigned to the Flavouring Group Evaluation 91 (FGE.91), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Forty‐four substances have been considered in FGE.91 and its re...

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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, Oskarsson, Agneta, 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, Vianello, Giorgia, Mennes, Wim
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7447996/
https://www.ncbi.nlm.nih.gov/pubmed/32874330
http://dx.doi.org/10.2903/j.efsa.2020.6154
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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
Oskarsson, Agneta
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
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
Oskarsson, Agneta
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
Vianello, Giorgia
Mennes, Wim
collection PubMed
description The EFSA Panel on Food Additives and Flavourings was requested to evaluate 49 flavouring substances assigned to the Flavouring Group Evaluation 91 (FGE.91), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Forty‐four substances have been considered in FGE.91 and its revisions (FGE.91Rev1 and FEG.91Rev2). With regard to the remaining five flavouring substances considered in this revision 3 of FGE.91: two ([FL‐no: 12.065 and 12.079]) have been cleared with respect to genotoxicity in FGE.201Rev2; two ([FL‐no: 12.169 and 12.241]) were originally allocated to FGE.74Rev4 and one ([FL‐no: 12.304]) to FGE.08Rev5. The Panel considered the flavouring substance [FL‐no: 12.169] representative for the tertiary monothiols [FL‐no: 12.038, 12.085, 12.137, 12.138, 12.145, 12.252, 12.259, 12.241 and 12.304]. 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 49 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. The specifications for the materials of commerce have also been considered and found adequate for all 49 flavouring substances. For five substances [FL‐no: 12.077, 12.162, 12.265, 12.267 and 17.036], evaluated through the Procedure in FGE.91Rev2, no normal and maximum use levels are available. For 10 substances [FL‐no: 12.065, 12.038, 12.079, 12.108, 12.139, 12.264, 12.274, 12.252, 12.284 and 12.304], the modified Theoretical Added Maximum Daily Intake (mTAMDI) intake estimates are above the TTC for their structural class. Therefore, for these 15 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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spelling pubmed-74479962020-08-31 Scientific Opinion on Flavouring Group Evaluation 91, Revision 3 (FGE.91Rev3): consideration of aliphatic, aromatic and α,β‐unsaturated sulfides and thiols evaluated by JECFA (53rd, 61st, 68th and 76th meetings), structurally related to substances in FGE.08Rev5 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 Oskarsson, Agneta 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 Vianello, Giorgia Mennes, Wim EFSA J Scientific Opinion The EFSA Panel on Food Additives and Flavourings was requested to evaluate 49 flavouring substances assigned to the Flavouring Group Evaluation 91 (FGE.91), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Forty‐four substances have been considered in FGE.91 and its revisions (FGE.91Rev1 and FEG.91Rev2). With regard to the remaining five flavouring substances considered in this revision 3 of FGE.91: two ([FL‐no: 12.065 and 12.079]) have been cleared with respect to genotoxicity in FGE.201Rev2; two ([FL‐no: 12.169 and 12.241]) were originally allocated to FGE.74Rev4 and one ([FL‐no: 12.304]) to FGE.08Rev5. The Panel considered the flavouring substance [FL‐no: 12.169] representative for the tertiary monothiols [FL‐no: 12.038, 12.085, 12.137, 12.138, 12.145, 12.252, 12.259, 12.241 and 12.304]. 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 49 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. The specifications for the materials of commerce have also been considered and found adequate for all 49 flavouring substances. For five substances [FL‐no: 12.077, 12.162, 12.265, 12.267 and 17.036], evaluated through the Procedure in FGE.91Rev2, no normal and maximum use levels are available. For 10 substances [FL‐no: 12.065, 12.038, 12.079, 12.108, 12.139, 12.264, 12.274, 12.252, 12.284 and 12.304], the modified Theoretical Added Maximum Daily Intake (mTAMDI) intake estimates are above the TTC for their structural class. Therefore, for these 15 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. John Wiley and Sons Inc. 2020-06-10 /pmc/articles/PMC7447996/ /pubmed/32874330 http://dx.doi.org/10.2903/j.efsa.2020.6154 Text en © 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 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
Oskarsson, Agneta
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
Vianello, Giorgia
Mennes, Wim
Scientific Opinion on Flavouring Group Evaluation 91, Revision 3 (FGE.91Rev3): consideration of aliphatic, aromatic and α,β‐unsaturated sulfides and thiols evaluated by JECFA (53rd, 61st, 68th and 76th meetings), structurally related to substances in FGE.08Rev5
title Scientific Opinion on Flavouring Group Evaluation 91, Revision 3 (FGE.91Rev3): consideration of aliphatic, aromatic and α,β‐unsaturated sulfides and thiols evaluated by JECFA (53rd, 61st, 68th and 76th meetings), structurally related to substances in FGE.08Rev5
title_full Scientific Opinion on Flavouring Group Evaluation 91, Revision 3 (FGE.91Rev3): consideration of aliphatic, aromatic and α,β‐unsaturated sulfides and thiols evaluated by JECFA (53rd, 61st, 68th and 76th meetings), structurally related to substances in FGE.08Rev5
title_fullStr Scientific Opinion on Flavouring Group Evaluation 91, Revision 3 (FGE.91Rev3): consideration of aliphatic, aromatic and α,β‐unsaturated sulfides and thiols evaluated by JECFA (53rd, 61st, 68th and 76th meetings), structurally related to substances in FGE.08Rev5
title_full_unstemmed Scientific Opinion on Flavouring Group Evaluation 91, Revision 3 (FGE.91Rev3): consideration of aliphatic, aromatic and α,β‐unsaturated sulfides and thiols evaluated by JECFA (53rd, 61st, 68th and 76th meetings), structurally related to substances in FGE.08Rev5
title_short Scientific Opinion on Flavouring Group Evaluation 91, Revision 3 (FGE.91Rev3): consideration of aliphatic, aromatic and α,β‐unsaturated sulfides and thiols evaluated by JECFA (53rd, 61st, 68th and 76th meetings), structurally related to substances in FGE.08Rev5
title_sort scientific opinion on flavouring group evaluation 91, revision 3 (fge.91rev3): consideration of aliphatic, aromatic and α,β‐unsaturated sulfides and thiols evaluated by jecfa (53rd, 61st, 68th and 76th meetings), structurally related to substances in fge.08rev5
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7447996/
https://www.ncbi.nlm.nih.gov/pubmed/32874330
http://dx.doi.org/10.2903/j.efsa.2020.6154
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