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Safety evaluation of the food enzyme β‐amylase from genetically modified Bacillus licheniformis strain NZYM‐JA

The food enzyme considered in this opinion is a β‐amylase (4‐α‐d‐glucan maltohydrolase; EC 3.2.1.2), produced with genetically modified Bacillus licheniformis strain NZYM‐JA by Novozymes A/S (Denmark). The β‐amylase food enzyme is intended to be used in starch processing for the production of glucos...

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Autores principales: Silano, Vittorio, Bolognesi, Claudia, Castle, Laurence, Cravedi, Jean‐Pierre, Fowler, Paul, Franz, Roland, Grob, Konrad, Gürtler, Rainer, Husøy, Trine, Kärenlampi, Sirpa, Mennes, Wim, Milana, Maria Rosaria, Penninks, André, Smith, Andrew, Tavares Poças, Maria de Fátima, Tlustos, Christina, Wölfle, Detlef, Zorn, Holger, Zugravu, Corina‐Aurelia, Chesson, Andrew, Glandorf, Boet, Herman, Lieve, Jany, Klaus‐Dieter, Marcon, Francesca, Želježic, Davor, Aguilera‐Gómez, Margarita, Andryszkiewicz, Magdalena, Divéki, Zoltán, Kovalkovičová, Natália, Engel, Karl‐Heinz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009947/
https://www.ncbi.nlm.nih.gov/pubmed/32625609
http://dx.doi.org/10.2903/j.efsa.2017.4896
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author Silano, Vittorio
Bolognesi, Claudia
Castle, Laurence
Cravedi, Jean‐Pierre
Fowler, Paul
Franz, Roland
Grob, Konrad
Gürtler, Rainer
Husøy, Trine
Kärenlampi, Sirpa
Mennes, Wim
Milana, Maria Rosaria
Penninks, André
Smith, Andrew
Tavares Poças, Maria de Fátima
Tlustos, Christina
Wölfle, Detlef
Zorn, Holger
Zugravu, Corina‐Aurelia
Chesson, Andrew
Glandorf, Boet
Herman, Lieve
Jany, Klaus‐Dieter
Marcon, Francesca
Želježic, Davor
Aguilera‐Gómez, Margarita
Andryszkiewicz, Magdalena
Divéki, Zoltán
Kovalkovičová, Natália
Engel, Karl‐Heinz
author_facet Silano, Vittorio
Bolognesi, Claudia
Castle, Laurence
Cravedi, Jean‐Pierre
Fowler, Paul
Franz, Roland
Grob, Konrad
Gürtler, Rainer
Husøy, Trine
Kärenlampi, Sirpa
Mennes, Wim
Milana, Maria Rosaria
Penninks, André
Smith, Andrew
Tavares Poças, Maria de Fátima
Tlustos, Christina
Wölfle, Detlef
Zorn, Holger
Zugravu, Corina‐Aurelia
Chesson, Andrew
Glandorf, Boet
Herman, Lieve
Jany, Klaus‐Dieter
Marcon, Francesca
Želježic, Davor
Aguilera‐Gómez, Margarita
Andryszkiewicz, Magdalena
Divéki, Zoltán
Kovalkovičová, Natália
Engel, Karl‐Heinz
collection PubMed
description The food enzyme considered in this opinion is a β‐amylase (4‐α‐d‐glucan maltohydrolase; EC 3.2.1.2), produced with genetically modified Bacillus licheniformis strain NZYM‐JA by Novozymes A/S (Denmark). The β‐amylase food enzyme is intended to be used in starch processing for the production of glucose syrups. Since the residual amounts of total organic solids (TOS) in glucose syrups after filtration and purification during starch processing were considered negligible, no dietary exposure was calculated. Toxicological tests made with the food enzyme under application indicated that there was no concern with respect to genotoxicity, mutagenicity or systemic toxicity. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no match was found. The Panel considers that there are no indications for allergic reactions. Based on the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the findings in the toxicological studies and allergenicity assessment, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.
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spelling pubmed-70099472020-07-02 Safety evaluation of the food enzyme β‐amylase from genetically modified Bacillus licheniformis strain NZYM‐JA Silano, Vittorio Bolognesi, Claudia Castle, Laurence Cravedi, Jean‐Pierre Fowler, Paul Franz, Roland Grob, Konrad Gürtler, Rainer Husøy, Trine Kärenlampi, Sirpa Mennes, Wim Milana, Maria Rosaria Penninks, André Smith, Andrew Tavares Poças, Maria de Fátima Tlustos, Christina Wölfle, Detlef Zorn, Holger Zugravu, Corina‐Aurelia Chesson, Andrew Glandorf, Boet Herman, Lieve Jany, Klaus‐Dieter Marcon, Francesca Želježic, Davor Aguilera‐Gómez, Margarita Andryszkiewicz, Magdalena Divéki, Zoltán Kovalkovičová, Natália Engel, Karl‐Heinz EFSA J Scientific Opinion The food enzyme considered in this opinion is a β‐amylase (4‐α‐d‐glucan maltohydrolase; EC 3.2.1.2), produced with genetically modified Bacillus licheniformis strain NZYM‐JA by Novozymes A/S (Denmark). The β‐amylase food enzyme is intended to be used in starch processing for the production of glucose syrups. Since the residual amounts of total organic solids (TOS) in glucose syrups after filtration and purification during starch processing were considered negligible, no dietary exposure was calculated. Toxicological tests made with the food enzyme under application indicated that there was no concern with respect to genotoxicity, mutagenicity or systemic toxicity. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no match was found. The Panel considers that there are no indications for allergic reactions. Based on the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the findings in the toxicological studies and allergenicity assessment, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use. John Wiley and Sons Inc. 2017-08-18 /pmc/articles/PMC7009947/ /pubmed/32625609 http://dx.doi.org/10.2903/j.efsa.2017.4896 Text en © 2017 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
Cravedi, Jean‐Pierre
Fowler, Paul
Franz, Roland
Grob, Konrad
Gürtler, Rainer
Husøy, Trine
Kärenlampi, Sirpa
Mennes, Wim
Milana, Maria Rosaria
Penninks, André
Smith, Andrew
Tavares Poças, Maria de Fátima
Tlustos, Christina
Wölfle, Detlef
Zorn, Holger
Zugravu, Corina‐Aurelia
Chesson, Andrew
Glandorf, Boet
Herman, Lieve
Jany, Klaus‐Dieter
Marcon, Francesca
Želježic, Davor
Aguilera‐Gómez, Margarita
Andryszkiewicz, Magdalena
Divéki, Zoltán
Kovalkovičová, Natália
Engel, Karl‐Heinz
Safety evaluation of the food enzyme β‐amylase from genetically modified Bacillus licheniformis strain NZYM‐JA
title Safety evaluation of the food enzyme β‐amylase from genetically modified Bacillus licheniformis strain NZYM‐JA
title_full Safety evaluation of the food enzyme β‐amylase from genetically modified Bacillus licheniformis strain NZYM‐JA
title_fullStr Safety evaluation of the food enzyme β‐amylase from genetically modified Bacillus licheniformis strain NZYM‐JA
title_full_unstemmed Safety evaluation of the food enzyme β‐amylase from genetically modified Bacillus licheniformis strain NZYM‐JA
title_short Safety evaluation of the food enzyme β‐amylase from genetically modified Bacillus licheniformis strain NZYM‐JA
title_sort safety evaluation of the food enzyme β‐amylase from genetically modified bacillus licheniformis strain nzym‐ja
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009947/
https://www.ncbi.nlm.nih.gov/pubmed/32625609
http://dx.doi.org/10.2903/j.efsa.2017.4896
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