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Safety evaluation of the food enzyme maltogenic amylase from the genetically modified Bacillus licheniformis strain DP‐Dzr50
The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain DP‐Dzr50 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. However, base...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008848/ https://www.ncbi.nlm.nih.gov/pubmed/32626504 http://dx.doi.org/10.2903/j.efsa.2020.5972 |
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author | Silano, Vittorio Barat Baviera, José Manuel Bolognesi, Claudia Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mortensen, Alicja Riviere, Gilles Steffensen, Inger‐Lise Tlustos, Christina van Loveren, Henk Vernis, Laurence Zorn, Holger Glandorf, Boet Herman, Lieve Andryszkiewicz, Magdalena Arcella, Davide Gomes, Ana Kovalkovičová, Natália Liu, Yi Chesson, Andrew |
author_facet | Silano, Vittorio Barat Baviera, José Manuel Bolognesi, Claudia Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mortensen, Alicja Riviere, Gilles Steffensen, Inger‐Lise Tlustos, Christina van Loveren, Henk Vernis, Laurence Zorn, Holger Glandorf, Boet Herman, Lieve Andryszkiewicz, Magdalena Arcella, Davide Gomes, Ana Kovalkovičová, Natália Liu, Yi Chesson, Andrew |
collection | PubMed |
description | The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain DP‐Dzr50 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in distilled alcohol production, starch processing for the production of glucose syrups, baking and brewing processes. Since residual amounts of the food enzyme are removed by distillation and starch processing, no dietary exposure was calculated for these processes. Based on the maximum use levels recommended for baking and brewing and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 0.199 mg TOS/kg body weight (bw) per day. 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 at least 80 mg TOS/kg bw per day which, compared to the estimated dietary exposure, results in a margin of exposure of at least 400. 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 by dietary exposure can be excluded in distilled alcohol production and is considered to be low in starch processing, baking and brewing. 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-7008848 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-70088482020-07-02 Safety evaluation of the food enzyme maltogenic amylase from the genetically modified Bacillus licheniformis strain DP‐Dzr50 Silano, Vittorio Barat Baviera, José Manuel Bolognesi, Claudia Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mortensen, Alicja Riviere, Gilles Steffensen, Inger‐Lise Tlustos, Christina van Loveren, Henk Vernis, Laurence Zorn, Holger Glandorf, Boet Herman, Lieve Andryszkiewicz, Magdalena Arcella, Davide Gomes, Ana Kovalkovičová, Natália Liu, Yi Chesson, Andrew EFSA J Scientific Opinion The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain DP‐Dzr50 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in distilled alcohol production, starch processing for the production of glucose syrups, baking and brewing processes. Since residual amounts of the food enzyme are removed by distillation and starch processing, no dietary exposure was calculated for these processes. Based on the maximum use levels recommended for baking and brewing and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 0.199 mg TOS/kg body weight (bw) per day. 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 at least 80 mg TOS/kg bw per day which, compared to the estimated dietary exposure, results in a margin of exposure of at least 400. 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 by dietary exposure can be excluded in distilled alcohol production and is considered to be low in starch processing, baking and brewing. 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. 2020-01-17 /pmc/articles/PMC7008848/ /pubmed/32626504 http://dx.doi.org/10.2903/j.efsa.2020.5972 Text en © 2020 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 Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mortensen, Alicja Riviere, Gilles Steffensen, Inger‐Lise Tlustos, Christina van Loveren, Henk Vernis, Laurence Zorn, Holger Glandorf, Boet Herman, Lieve Andryszkiewicz, Magdalena Arcella, Davide Gomes, Ana Kovalkovičová, Natália Liu, Yi Chesson, Andrew Safety evaluation of the food enzyme maltogenic amylase from the genetically modified Bacillus licheniformis strain DP‐Dzr50 |
title | Safety evaluation of the food enzyme maltogenic amylase from the genetically modified Bacillus licheniformis strain DP‐Dzr50 |
title_full | Safety evaluation of the food enzyme maltogenic amylase from the genetically modified Bacillus licheniformis strain DP‐Dzr50 |
title_fullStr | Safety evaluation of the food enzyme maltogenic amylase from the genetically modified Bacillus licheniformis strain DP‐Dzr50 |
title_full_unstemmed | Safety evaluation of the food enzyme maltogenic amylase from the genetically modified Bacillus licheniformis strain DP‐Dzr50 |
title_short | Safety evaluation of the food enzyme maltogenic amylase from the genetically modified Bacillus licheniformis strain DP‐Dzr50 |
title_sort | safety evaluation of the food enzyme maltogenic amylase from the genetically modified bacillus licheniformis strain dp‐dzr50 |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008848/ https://www.ncbi.nlm.nih.gov/pubmed/32626504 http://dx.doi.org/10.2903/j.efsa.2020.5972 |
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