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Scientific Opinion of Flavouring Group Evaluation 406 (FGE.406): (S)‐1‐(3‐(((4‐amino‐2,2‐dioxido‐1H‐benzo[c][1,2,6]thiadiazin‐5‐yl)oxy)methyl)piperidin‐1‐yl)‐3‐methylbutan‐1‐one
The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of EFSA was requested to deliver a scientific opinion on the safety of the use of the substance (S)‐1‐(3‐(((4‐amino‐2,2‐dioxido‐1H‐benzo[c][1,2,6]thiadiazin‐5‐yl)oxy)methyl)piperidin‐1‐yl)‐3‐methylbutan‐1‐one [FL‐no:...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009732/ https://www.ncbi.nlm.nih.gov/pubmed/32625796 http://dx.doi.org/10.2903/j.efsa.2018.5120 |
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author | Silano, Vittorio Bolognesi, Claudia Castle, Laurence Chipman, Kevin Cravedi, Jean‐Pierre Engel, Karl‐Heinz Fowler, Paul Franz, Roland Grob, Konrad Gürtler, Rainer Husøy, Trine Kärenlampi, Sirpa Milana, Maria Rosaria Pfaff, Karla Riviere, Gilles Srinivasan, Jannavi Tavares Poças, Maria de Fátima Tlustos, Christina Wölfle, Detlef Zorn, Holger Beckman Sundh, Ulla Benigni, Romualdo Binderup, Mona‐Lise Brimer, Leon Marcon, Francesca Marzin, Daniel Mosesso, Pasquale Mulder, Gerard Oskarsson, Agneta Svendsen, Camilla Van Benthem, Jan Anastassiadou, Maria Carfì, Maria Mennes, Wim |
author_facet | Silano, Vittorio Bolognesi, Claudia Castle, Laurence Chipman, Kevin Cravedi, Jean‐Pierre Engel, Karl‐Heinz Fowler, Paul Franz, Roland Grob, Konrad Gürtler, Rainer Husøy, Trine Kärenlampi, Sirpa Milana, Maria Rosaria Pfaff, Karla Riviere, Gilles Srinivasan, Jannavi Tavares Poças, Maria de Fátima Tlustos, Christina Wölfle, Detlef Zorn, Holger Beckman Sundh, Ulla Benigni, Romualdo Binderup, Mona‐Lise Brimer, Leon Marcon, Francesca Marzin, Daniel Mosesso, Pasquale Mulder, Gerard Oskarsson, Agneta Svendsen, Camilla Van Benthem, Jan Anastassiadou, Maria Carfì, Maria Mennes, Wim |
collection | PubMed |
description | The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of EFSA was requested to deliver a scientific opinion on the safety of the use of the substance (S)‐1‐(3‐(((4‐amino‐2,2‐dioxido‐1H‐benzo[c][1,2,6]thiadiazin‐5‐yl)oxy)methyl)piperidin‐1‐yl)‐3‐methylbutan‐1‐one [FL‐no: 16.129], as a flavouring substance. The substance is intended to be used in the form of its sodium salt as a flavour modifier in beverages. The Panel concluded that [FL‐no: 16.129] would not raise a concern with respect to genotoxicity under conditions where it remains stable and does not undergo photodegradation. However, the data provided do not rule out genotoxicity for the degradation products. A 90‐day toxicity study with [FL‐no: 16.129] in rats showed no adverse effects at exposure up to 100 mg/kg body weight (bw) per day. No developmental toxicity was observed in rats at dose levels up to 1,000 mg/kg bw per day. An adequate margin of safety was calculated for [FL‐no: 16.129]. The Panel concluded that [FL‐no: 16.129] and its sodium salt are not expected to be of safety concern at the estimated levels of intake. This conclusion applies only to the use of the substance as a flavour modifier at levels up to those specified in beverages, but not to the degradation products that may be formed upon exposure to ultraviolet‐A (UV‐A) light. The conditions protecting [FL‐no: 16.129] from photodegradation have not been adequately investigated. It is also unclear if degradation occurs in the absence of UV light. Based on the data provided, the Panel cannot conclude on the safety of [FL‐no: 16.129] when used as a flavour modifier. |
format | Online Article Text |
id | pubmed-7009732 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-70097322020-07-02 Scientific Opinion of Flavouring Group Evaluation 406 (FGE.406): (S)‐1‐(3‐(((4‐amino‐2,2‐dioxido‐1H‐benzo[c][1,2,6]thiadiazin‐5‐yl)oxy)methyl)piperidin‐1‐yl)‐3‐methylbutan‐1‐one Silano, Vittorio Bolognesi, Claudia Castle, Laurence Chipman, Kevin Cravedi, Jean‐Pierre Engel, Karl‐Heinz Fowler, Paul Franz, Roland Grob, Konrad Gürtler, Rainer Husøy, Trine Kärenlampi, Sirpa Milana, Maria Rosaria Pfaff, Karla Riviere, Gilles Srinivasan, Jannavi Tavares Poças, Maria de Fátima Tlustos, Christina Wölfle, Detlef Zorn, Holger Beckman Sundh, Ulla Benigni, Romualdo Binderup, Mona‐Lise Brimer, Leon Marcon, Francesca Marzin, Daniel Mosesso, Pasquale Mulder, Gerard Oskarsson, Agneta Svendsen, Camilla Van Benthem, Jan Anastassiadou, Maria Carfì, Maria Mennes, Wim EFSA J Scientific Opinion The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of EFSA was requested to deliver a scientific opinion on the safety of the use of the substance (S)‐1‐(3‐(((4‐amino‐2,2‐dioxido‐1H‐benzo[c][1,2,6]thiadiazin‐5‐yl)oxy)methyl)piperidin‐1‐yl)‐3‐methylbutan‐1‐one [FL‐no: 16.129], as a flavouring substance. The substance is intended to be used in the form of its sodium salt as a flavour modifier in beverages. The Panel concluded that [FL‐no: 16.129] would not raise a concern with respect to genotoxicity under conditions where it remains stable and does not undergo photodegradation. However, the data provided do not rule out genotoxicity for the degradation products. A 90‐day toxicity study with [FL‐no: 16.129] in rats showed no adverse effects at exposure up to 100 mg/kg body weight (bw) per day. No developmental toxicity was observed in rats at dose levels up to 1,000 mg/kg bw per day. An adequate margin of safety was calculated for [FL‐no: 16.129]. The Panel concluded that [FL‐no: 16.129] and its sodium salt are not expected to be of safety concern at the estimated levels of intake. This conclusion applies only to the use of the substance as a flavour modifier at levels up to those specified in beverages, but not to the degradation products that may be formed upon exposure to ultraviolet‐A (UV‐A) light. The conditions protecting [FL‐no: 16.129] from photodegradation have not been adequately investigated. It is also unclear if degradation occurs in the absence of UV light. Based on the data provided, the Panel cannot conclude on the safety of [FL‐no: 16.129] when used as a flavour modifier. John Wiley and Sons Inc. 2018-02-23 /pmc/articles/PMC7009732/ /pubmed/32625796 http://dx.doi.org/10.2903/j.efsa.2018.5120 Text en © 2018 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 Silano, Vittorio Bolognesi, Claudia Castle, Laurence Chipman, Kevin Cravedi, Jean‐Pierre Engel, Karl‐Heinz Fowler, Paul Franz, Roland Grob, Konrad Gürtler, Rainer Husøy, Trine Kärenlampi, Sirpa Milana, Maria Rosaria Pfaff, Karla Riviere, Gilles Srinivasan, Jannavi Tavares Poças, Maria de Fátima Tlustos, Christina Wölfle, Detlef Zorn, Holger Beckman Sundh, Ulla Benigni, Romualdo Binderup, Mona‐Lise Brimer, Leon Marcon, Francesca Marzin, Daniel Mosesso, Pasquale Mulder, Gerard Oskarsson, Agneta Svendsen, Camilla Van Benthem, Jan Anastassiadou, Maria Carfì, Maria Mennes, Wim Scientific Opinion of Flavouring Group Evaluation 406 (FGE.406): (S)‐1‐(3‐(((4‐amino‐2,2‐dioxido‐1H‐benzo[c][1,2,6]thiadiazin‐5‐yl)oxy)methyl)piperidin‐1‐yl)‐3‐methylbutan‐1‐one |
title | Scientific Opinion of Flavouring Group Evaluation 406 (FGE.406): (S)‐1‐(3‐(((4‐amino‐2,2‐dioxido‐1H‐benzo[c][1,2,6]thiadiazin‐5‐yl)oxy)methyl)piperidin‐1‐yl)‐3‐methylbutan‐1‐one |
title_full | Scientific Opinion of Flavouring Group Evaluation 406 (FGE.406): (S)‐1‐(3‐(((4‐amino‐2,2‐dioxido‐1H‐benzo[c][1,2,6]thiadiazin‐5‐yl)oxy)methyl)piperidin‐1‐yl)‐3‐methylbutan‐1‐one |
title_fullStr | Scientific Opinion of Flavouring Group Evaluation 406 (FGE.406): (S)‐1‐(3‐(((4‐amino‐2,2‐dioxido‐1H‐benzo[c][1,2,6]thiadiazin‐5‐yl)oxy)methyl)piperidin‐1‐yl)‐3‐methylbutan‐1‐one |
title_full_unstemmed | Scientific Opinion of Flavouring Group Evaluation 406 (FGE.406): (S)‐1‐(3‐(((4‐amino‐2,2‐dioxido‐1H‐benzo[c][1,2,6]thiadiazin‐5‐yl)oxy)methyl)piperidin‐1‐yl)‐3‐methylbutan‐1‐one |
title_short | Scientific Opinion of Flavouring Group Evaluation 406 (FGE.406): (S)‐1‐(3‐(((4‐amino‐2,2‐dioxido‐1H‐benzo[c][1,2,6]thiadiazin‐5‐yl)oxy)methyl)piperidin‐1‐yl)‐3‐methylbutan‐1‐one |
title_sort | scientific opinion of flavouring group evaluation 406 (fge.406): (s)‐1‐(3‐(((4‐amino‐2,2‐dioxido‐1h‐benzo[c][1,2,6]thiadiazin‐5‐yl)oxy)methyl)piperidin‐1‐yl)‐3‐methylbutan‐1‐one |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009732/ https://www.ncbi.nlm.nih.gov/pubmed/32625796 http://dx.doi.org/10.2903/j.efsa.2018.5120 |
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