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Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus subtilis strain AR‐651
The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus subtilis strain AR‐651 by AB Enzymes. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organis...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9936607/ https://www.ncbi.nlm.nih.gov/pubmed/36818640 http://dx.doi.org/10.2903/j.efsa.2023.7468 |
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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 Aguilera, Jaime Andryszkiewicz, Magdalena 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 Aguilera, Jaime Andryszkiewicz, Magdalena Liu, Yi Chesson, Andrew |
collection | PubMed |
description | The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus subtilis strain AR‐651 by AB Enzymes. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in baking processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.19 mg TOS/kg body weight (bw) per day in European populations. The production strain carries known antimicrobial resistance genes and consequently, it does not fully fulfil the requirements for the qualified presumption of safety (QPS) approach to safety assessment. However, considering the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel considers that toxicological tests are not needed for the assessment of this food enzyme. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and three matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use, 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 concludes that this food enzyme does not give rise to safety concerns, under the intended conditions of use. |
format | Online Article Text |
id | pubmed-9936607 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-99366072023-02-18 Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus subtilis strain AR‐651 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 Aguilera, Jaime Andryszkiewicz, Magdalena Liu, Yi Chesson, Andrew EFSA J Scientific Opinion The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus subtilis strain AR‐651 by AB Enzymes. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in baking processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.19 mg TOS/kg body weight (bw) per day in European populations. The production strain carries known antimicrobial resistance genes and consequently, it does not fully fulfil the requirements for the qualified presumption of safety (QPS) approach to safety assessment. However, considering the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel considers that toxicological tests are not needed for the assessment of this food enzyme. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and three matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use, 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 concludes that this food enzyme does not give rise to safety concerns, under the intended conditions of use. John Wiley and Sons Inc. 2023-02-17 /pmc/articles/PMC9936607/ /pubmed/36818640 http://dx.doi.org/10.2903/j.efsa.2023.7468 Text en © 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH 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 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 Aguilera, Jaime Andryszkiewicz, Magdalena Liu, Yi Chesson, Andrew Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus subtilis strain AR‐651 |
title | Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus subtilis strain AR‐651 |
title_full | Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus subtilis strain AR‐651 |
title_fullStr | Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus subtilis strain AR‐651 |
title_full_unstemmed | Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus subtilis strain AR‐651 |
title_short | Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus subtilis strain AR‐651 |
title_sort | safety evaluation of the food enzyme α‐amylase from the genetically modified bacillus subtilis strain ar‐651 |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9936607/ https://www.ncbi.nlm.nih.gov/pubmed/36818640 http://dx.doi.org/10.2903/j.efsa.2023.7468 |
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