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Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)
The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC 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...
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/PMC7009494/ https://www.ncbi.nlm.nih.gov/pubmed/32625759 http://dx.doi.org/10.2903/j.efsa.2018.5477 |
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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 Herman, Lieve Penninks, André 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 Herman, Lieve Penninks, André 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‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC 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 recommended, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.649 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 in rats. The Panel identified a no observed adverse effect level at the mid‐dose of 371 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. |
format | Online Article Text |
id | pubmed-7009494 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-70094942020-07-02 Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC) 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 Herman, Lieve Penninks, André 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‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC 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 recommended, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.649 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 in rats. The Panel identified a no observed adverse effect level at the mid‐dose of 371 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/PMC7009494/ /pubmed/32625759 http://dx.doi.org/10.2903/j.efsa.2018.5477 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 Herman, Lieve Penninks, André 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‐OC) |
title | Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC) |
title_full | Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC) |
title_fullStr | Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC) |
title_full_unstemmed | Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC) |
title_short | Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC) |
title_sort | safety evaluation of the food enzyme maltogenic amylase from a genetically modified bacillus subtilis (strain nzym‐oc) |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009494/ https://www.ncbi.nlm.nih.gov/pubmed/32625759 http://dx.doi.org/10.2903/j.efsa.2018.5477 |
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