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Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microor...

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Autores principales: Silano, Vittorio, Barat Baviera, José Manuel, Bolognesi, Claudia, Brüschweiler, Beat Johannes, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Glandorf, Boet, Penninks, André, Smith, Andrew, Želježic, Davor, Aguilera, Jaime, Kovalkovičová, Natália, Liu, Yi, Maia, Joaquim, Roncancio Peña, Claudia, Chesson, Andrew
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/PMC7009716/
https://www.ncbi.nlm.nih.gov/pubmed/32625760
http://dx.doi.org/10.2903/j.efsa.2018.5478
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author Silano, Vittorio
Barat Baviera, José Manuel
Bolognesi, Claudia
Brüschweiler, Beat Johannes
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lampi, Evgenia
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Glandorf, Boet
Penninks, André
Smith, Andrew
Želježic, Davor
Aguilera, Jaime
Kovalkovičová, Natália
Liu, Yi
Maia, Joaquim
Roncancio Peña, Claudia
Chesson, Andrew
author_facet Silano, Vittorio
Barat Baviera, José Manuel
Bolognesi, Claudia
Brüschweiler, Beat Johannes
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lampi, Evgenia
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Glandorf, Boet
Penninks, André
Smith, Andrew
Želježic, Davor
Aguilera, Jaime
Kovalkovičová, Natália
Liu, Yi
Maia, Joaquim
Roncancio Peña, Claudia
Chesson, Andrew
collection PubMed
description The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organic Solids (TOS) was estimated to be up to 0.556 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level at the mid‐dose of 318.4 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (at least 570). Similarity of the amino acid sequence to those of known allergens was searched and three matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
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spelling pubmed-70097162020-07-02 Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO) Silano, Vittorio Barat Baviera, José Manuel Bolognesi, Claudia Brüschweiler, Beat Johannes Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mortensen, Alicja Rivière, Gilles Steffensen, Inger‐Lise Tlustos, Christina van Loveren, Henk Vernis, Laurence Zorn, Holger Glandorf, Boet Penninks, André Smith, Andrew Želježic, Davor Aguilera, Jaime Kovalkovičová, Natália Liu, Yi Maia, Joaquim Roncancio Peña, Claudia Chesson, Andrew EFSA J Scientific Opinion The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organic Solids (TOS) was estimated to be up to 0.556 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level at the mid‐dose of 318.4 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (at least 570). Similarity of the amino acid sequence to those of known allergens was searched and three matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. John Wiley and Sons Inc. 2018-11-14 /pmc/articles/PMC7009716/ /pubmed/32625760 http://dx.doi.org/10.2903/j.efsa.2018.5478 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
Barat Baviera, José Manuel
Bolognesi, Claudia
Brüschweiler, Beat Johannes
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lampi, Evgenia
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Glandorf, Boet
Penninks, André
Smith, Andrew
Želježic, Davor
Aguilera, Jaime
Kovalkovičová, Natália
Liu, Yi
Maia, Joaquim
Roncancio Peña, Claudia
Chesson, Andrew
Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)
title Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)
title_full Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)
title_fullStr Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)
title_full_unstemmed Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)
title_short Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)
title_sort safety evaluation of the food enzyme maltogenic amylase from a genetically modified bacillus subtilis (strain nzym‐so)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009716/
https://www.ncbi.nlm.nih.gov/pubmed/32625760
http://dx.doi.org/10.2903/j.efsa.2018.5478
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