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Safety evaluation of the food enzyme glucan 1,4 α‐glucosidase from the genetically modified Aspergillus niger strain NZYM‐BR
The food enzyme glucan 1,4‐α‐glucosidase (4‐α‐d‐glucan glucohydrolase, EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BR 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 o...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8905423/ https://www.ncbi.nlm.nih.gov/pubmed/35281642 http://dx.doi.org/10.2903/j.efsa.2022.7191 |
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author | Lambré, Claude Barat Baviera, José Manuel Bolognesi, Claudia Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mengelers, Marcel Mortensen, Alicja Rivière, Gilles Steffensen, Inger‐Lise Tlustos, Christina Van Loveren, Henk Vernis, Laurence Zorn, Holger Glandorf, Boet Herman, Lieve Aguilera, Jaime Andryszkiewicz, Magdalena Kovalkovicova, Natalia Liu, Yi Chesson, Andrew |
author_facet | Lambré, Claude Barat Baviera, José Manuel Bolognesi, Claudia Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mengelers, Marcel Mortensen, Alicja Rivière, Gilles Steffensen, Inger‐Lise Tlustos, Christina Van Loveren, Henk Vernis, Laurence Zorn, Holger Glandorf, Boet Herman, Lieve Aguilera, Jaime Andryszkiewicz, Magdalena Kovalkovicova, Natalia Liu, Yi Chesson, Andrew |
collection | PubMed |
description | The food enzyme glucan 1,4‐α‐glucosidase (4‐α‐d‐glucan glucohydrolase, EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BR 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 organism and its DNA. The food enzyme is intended to be used in starch processing for the production of glucose syrups and distilled alcohol. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups and by distillation, dietary exposure estimation was considered not necessary. 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 of 1,135 mg TOS/kg body weight (bw) per day, the highest dose tested. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched for and two matches were found. The Panel considered that under the intended conditions of use (other than distilled alcohol production) the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this 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-8905423 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-89054232022-03-10 Safety evaluation of the food enzyme glucan 1,4 α‐glucosidase from the genetically modified Aspergillus niger strain NZYM‐BR Lambré, Claude Barat Baviera, José Manuel Bolognesi, Claudia Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mengelers, Marcel Mortensen, Alicja Rivière, Gilles Steffensen, Inger‐Lise Tlustos, Christina Van Loveren, Henk Vernis, Laurence Zorn, Holger Glandorf, Boet Herman, Lieve Aguilera, Jaime Andryszkiewicz, Magdalena Kovalkovicova, Natalia Liu, Yi Chesson, Andrew EFSA J Scientific Opinion The food enzyme glucan 1,4‐α‐glucosidase (4‐α‐d‐glucan glucohydrolase, EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BR 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 organism and its DNA. The food enzyme is intended to be used in starch processing for the production of glucose syrups and distilled alcohol. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups and by distillation, dietary exposure estimation was considered not necessary. 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 of 1,135 mg TOS/kg body weight (bw) per day, the highest dose tested. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched for and two matches were found. The Panel considered that under the intended conditions of use (other than distilled alcohol production) the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this 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. 2022-03-09 /pmc/articles/PMC8905423/ /pubmed/35281642 http://dx.doi.org/10.2903/j.efsa.2022.7191 Text en © 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the 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 Lambré, Claude Barat Baviera, José Manuel Bolognesi, Claudia Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mengelers, Marcel Mortensen, Alicja Rivière, Gilles Steffensen, Inger‐Lise Tlustos, Christina Van Loveren, Henk Vernis, Laurence Zorn, Holger Glandorf, Boet Herman, Lieve Aguilera, Jaime Andryszkiewicz, Magdalena Kovalkovicova, Natalia Liu, Yi Chesson, Andrew Safety evaluation of the food enzyme glucan 1,4 α‐glucosidase from the genetically modified Aspergillus niger strain NZYM‐BR |
title | Safety evaluation of the food enzyme glucan 1,4 α‐glucosidase from the genetically modified Aspergillus niger strain NZYM‐BR |
title_full | Safety evaluation of the food enzyme glucan 1,4 α‐glucosidase from the genetically modified Aspergillus niger strain NZYM‐BR |
title_fullStr | Safety evaluation of the food enzyme glucan 1,4 α‐glucosidase from the genetically modified Aspergillus niger strain NZYM‐BR |
title_full_unstemmed | Safety evaluation of the food enzyme glucan 1,4 α‐glucosidase from the genetically modified Aspergillus niger strain NZYM‐BR |
title_short | Safety evaluation of the food enzyme glucan 1,4 α‐glucosidase from the genetically modified Aspergillus niger strain NZYM‐BR |
title_sort | safety evaluation of the food enzyme glucan 1,4 α‐glucosidase from the genetically modified aspergillus niger strain nzym‐br |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8905423/ https://www.ncbi.nlm.nih.gov/pubmed/35281642 http://dx.doi.org/10.2903/j.efsa.2022.7191 |
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