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Safety evaluation of the food enzyme xylanase from a genetically modified Bacillus subtilis strain TD160(229)

The food enzyme considered in this opinion is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified Bacillus subtilis strain from Puratos N.V. (Belgium). The genetic modifications do not raise safety concerns. The food enzyme contains neither the production organism nor recombinan...

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Autores principales: Silano, Vittorio, Bolognesi, Claudia, Castle, Laurence, Chipman, Kevin, Cravedi, Jean‐Pierre, Fowler, Paul, Franz, Roland, Grob, Konrad, Gürtler, Rainer, Husøy, Trine, Kärenlampi, Sirpa, Mennes, Wim, Milana, Maria Rosaria, Pfaff, Karla, Riviere, Gilles, Srinivasan, Jannavi, Tavares Poças, Maria de Fátima, Tlustos, Christina, Wölfle, Detlef, Zorn, Holger, Chesson, Andrew, Glandorf, Boet, Herman, Lieve, Jany, Klaus‐Dieter, Marcon, Francesca, Penninks, André, Smith, Andrew, Želježić, Davor, Aguilera‐Gómez, Margarita, Andryszkiewicz, Magdalena, Arcella, Davide, Kovalkovičová, Natália, Liu, Yi, Maia, Joaquim, Engel, Karl‐Heinz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009708/
https://www.ncbi.nlm.nih.gov/pubmed/32625651
http://dx.doi.org/10.2903/j.efsa.2018.5008
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author Silano, Vittorio
Bolognesi, Claudia
Castle, Laurence
Chipman, Kevin
Cravedi, Jean‐Pierre
Fowler, Paul
Franz, Roland
Grob, Konrad
Gürtler, Rainer
Husøy, Trine
Kärenlampi, Sirpa
Mennes, Wim
Milana, Maria Rosaria
Pfaff, Karla
Riviere, Gilles
Srinivasan, Jannavi
Tavares Poças, Maria de Fátima
Tlustos, Christina
Wölfle, Detlef
Zorn, Holger
Chesson, Andrew
Glandorf, Boet
Herman, Lieve
Jany, Klaus‐Dieter
Marcon, Francesca
Penninks, André
Smith, Andrew
Želježić, Davor
Aguilera‐Gómez, Margarita
Andryszkiewicz, Magdalena
Arcella, Davide
Kovalkovičová, Natália
Liu, Yi
Maia, Joaquim
Engel, Karl‐Heinz
author_facet Silano, Vittorio
Bolognesi, Claudia
Castle, Laurence
Chipman, Kevin
Cravedi, Jean‐Pierre
Fowler, Paul
Franz, Roland
Grob, Konrad
Gürtler, Rainer
Husøy, Trine
Kärenlampi, Sirpa
Mennes, Wim
Milana, Maria Rosaria
Pfaff, Karla
Riviere, Gilles
Srinivasan, Jannavi
Tavares Poças, Maria de Fátima
Tlustos, Christina
Wölfle, Detlef
Zorn, Holger
Chesson, Andrew
Glandorf, Boet
Herman, Lieve
Jany, Klaus‐Dieter
Marcon, Francesca
Penninks, André
Smith, Andrew
Želježić, Davor
Aguilera‐Gómez, Margarita
Andryszkiewicz, Magdalena
Arcella, Davide
Kovalkovičová, Natália
Liu, Yi
Maia, Joaquim
Engel, Karl‐Heinz
collection PubMed
description The food enzyme considered in this opinion is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified Bacillus subtilis strain from Puratos N.V. (Belgium). The genetic modifications do not raise safety concerns. The food enzyme contains neither the production organism nor recombinant DNA. The endo‐1,4‐β‐xylanase is intended to be used in baking processes. Based on the maximum use levels recommended for the baking processes, dietary exposure to the food enzyme–total organic solids (TOS) was estimated on the basis of individual data from the EFSA Comprehensive European Food Consumption Database. This exposure estimate is up to 0.008 mg TOS/kg body weight per day in European populations. The food enzyme did not induce gene mutations in bacteria nor clastogenic activity in human lymphocytes. Therefore, there is no concern with respect to genotoxicity. The subchronic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rodents. A no observed adverse effect level was derived, which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no matches were found. The Panel considered that there are no indications for food allergic reactions to this xylanase. Based on the microbial source, genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the findings in the toxicological studies and allergenicity assessment, this food enzyme does not give rise to safety concerns under the intended conditions of use.
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spelling pubmed-70097082020-07-02 Safety evaluation of the food enzyme xylanase from a genetically modified Bacillus subtilis strain TD160(229) Silano, Vittorio Bolognesi, Claudia Castle, Laurence Chipman, Kevin Cravedi, Jean‐Pierre Fowler, Paul Franz, Roland Grob, Konrad Gürtler, Rainer Husøy, Trine Kärenlampi, Sirpa Mennes, Wim Milana, Maria Rosaria Pfaff, Karla Riviere, Gilles Srinivasan, Jannavi Tavares Poças, Maria de Fátima Tlustos, Christina Wölfle, Detlef Zorn, Holger Chesson, Andrew Glandorf, Boet Herman, Lieve Jany, Klaus‐Dieter Marcon, Francesca Penninks, André Smith, Andrew Želježić, Davor Aguilera‐Gómez, Margarita Andryszkiewicz, Magdalena Arcella, Davide Kovalkovičová, Natália Liu, Yi Maia, Joaquim Engel, Karl‐Heinz EFSA J Scientific Opinion The food enzyme considered in this opinion is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified Bacillus subtilis strain from Puratos N.V. (Belgium). The genetic modifications do not raise safety concerns. The food enzyme contains neither the production organism nor recombinant DNA. The endo‐1,4‐β‐xylanase is intended to be used in baking processes. Based on the maximum use levels recommended for the baking processes, dietary exposure to the food enzyme–total organic solids (TOS) was estimated on the basis of individual data from the EFSA Comprehensive European Food Consumption Database. This exposure estimate is up to 0.008 mg TOS/kg body weight per day in European populations. The food enzyme did not induce gene mutations in bacteria nor clastogenic activity in human lymphocytes. Therefore, there is no concern with respect to genotoxicity. The subchronic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rodents. A no observed adverse effect level was derived, which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no matches were found. The Panel considered that there are no indications for food allergic reactions to this xylanase. Based on the microbial source, genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the findings in the toxicological studies and allergenicity assessment, this food enzyme does not give rise to safety concerns under the intended conditions of use. John Wiley and Sons Inc. 2018-01-22 /pmc/articles/PMC7009708/ /pubmed/32625651 http://dx.doi.org/10.2903/j.efsa.2018.5008 Text en © 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://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
Fowler, Paul
Franz, Roland
Grob, Konrad
Gürtler, Rainer
Husøy, Trine
Kärenlampi, Sirpa
Mennes, Wim
Milana, Maria Rosaria
Pfaff, Karla
Riviere, Gilles
Srinivasan, Jannavi
Tavares Poças, Maria de Fátima
Tlustos, Christina
Wölfle, Detlef
Zorn, Holger
Chesson, Andrew
Glandorf, Boet
Herman, Lieve
Jany, Klaus‐Dieter
Marcon, Francesca
Penninks, André
Smith, Andrew
Želježić, Davor
Aguilera‐Gómez, Margarita
Andryszkiewicz, Magdalena
Arcella, Davide
Kovalkovičová, Natália
Liu, Yi
Maia, Joaquim
Engel, Karl‐Heinz
Safety evaluation of the food enzyme xylanase from a genetically modified Bacillus subtilis strain TD160(229)
title Safety evaluation of the food enzyme xylanase from a genetically modified Bacillus subtilis strain TD160(229)
title_full Safety evaluation of the food enzyme xylanase from a genetically modified Bacillus subtilis strain TD160(229)
title_fullStr Safety evaluation of the food enzyme xylanase from a genetically modified Bacillus subtilis strain TD160(229)
title_full_unstemmed Safety evaluation of the food enzyme xylanase from a genetically modified Bacillus subtilis strain TD160(229)
title_short Safety evaluation of the food enzyme xylanase from a genetically modified Bacillus subtilis strain TD160(229)
title_sort safety evaluation of the food enzyme xylanase from a genetically modified bacillus subtilis strain td160(229)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009708/
https://www.ncbi.nlm.nih.gov/pubmed/32625651
http://dx.doi.org/10.2903/j.efsa.2018.5008
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