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Safety evaluation of the food enzyme maltogenic amylase from genetically modified Escherichia coli (strain BLASC)
The food enzyme, a maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133), is produced with a genetically modified Escherichia coli strain BLASC by Advanced Enzyme Technologies Ltd. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of th...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009224/ https://www.ncbi.nlm.nih.gov/pubmed/32626382 http://dx.doi.org/10.2903/j.efsa.2019.5769 |
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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 Rivière, Gilles Steffensen, Inger‐Lise Tlustos, Christina Van Loveren, Henk Vernis, Laurence Zorn, Holger Glandorf, Boet Herman, Lieve Jany, Klaus‐Dieter Marcon, Francesca Penninks, André Arcella, Davide Gomes, Ana Kovalkovičová, Natália Liu, Yi Maia, Joaquim Roncancio Peña, Claudia Nuin, Irene 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 Rivière, Gilles Steffensen, Inger‐Lise Tlustos, Christina Van Loveren, Henk Vernis, Laurence Zorn, Holger Glandorf, Boet Herman, Lieve Jany, Klaus‐Dieter Marcon, Francesca Penninks, André Arcella, Davide Gomes, Ana Kovalkovičová, Natália Liu, Yi Maia, Joaquim Roncancio Peña, Claudia Nuin, Irene Chesson, Andrew |
collection | PubMed |
description | The food enzyme, a maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133), is produced with a genetically modified Escherichia coli strain BLASC by Advanced Enzyme Technologies Ltd. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This maltogenic amylase is intended to be used in baking and brewing processes and starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups; consequently, dietary exposure was not calculated for this food process. For baking and brewing processes, based on the maximum use levels recommended for food processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–TOS was estimated to be up to 0.107 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 at the highest dose tested of 838 mg TOS/kg bw per day that, compared with the estimated dietary exposure, resulted in a sufficiently high margin of exposure (at least 7,800). Similarity of the amino acid sequence to those of known allergens was searched and one match was found with respiratory allergen produced by Aspergillus oryzae. The Panel considered that, under the intended conditions of use, the risk for allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reaction to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use. |
format | Online Article Text |
id | pubmed-7009224 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-70092242020-07-02 Safety evaluation of the food enzyme maltogenic amylase from genetically modified Escherichia coli (strain BLASC) Silano, Vittorio Barat Baviera, José Manuel Bolognesi, Claudia 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 Herman, Lieve Jany, Klaus‐Dieter Marcon, Francesca Penninks, André Arcella, Davide Gomes, Ana Kovalkovičová, Natália Liu, Yi Maia, Joaquim Roncancio Peña, Claudia Nuin, Irene Chesson, Andrew EFSA J Scientific Opinion The food enzyme, a maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133), is produced with a genetically modified Escherichia coli strain BLASC by Advanced Enzyme Technologies Ltd. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This maltogenic amylase is intended to be used in baking and brewing processes and starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups; consequently, dietary exposure was not calculated for this food process. For baking and brewing processes, based on the maximum use levels recommended for food processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–TOS was estimated to be up to 0.107 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 at the highest dose tested of 838 mg TOS/kg bw per day that, compared with the estimated dietary exposure, resulted in a sufficiently high margin of exposure (at least 7,800). Similarity of the amino acid sequence to those of known allergens was searched and one match was found with respiratory allergen produced by Aspergillus oryzae. The Panel considered that, under the intended conditions of use, the risk for allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reaction to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use. John Wiley and Sons Inc. 2019-07-29 /pmc/articles/PMC7009224/ /pubmed/32626382 http://dx.doi.org/10.2903/j.efsa.2019.5769 Text en © 2019 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 Rivière, Gilles Steffensen, Inger‐Lise Tlustos, Christina Van Loveren, Henk Vernis, Laurence Zorn, Holger Glandorf, Boet Herman, Lieve Jany, Klaus‐Dieter Marcon, Francesca Penninks, André Arcella, Davide Gomes, Ana Kovalkovičová, Natália Liu, Yi Maia, Joaquim Roncancio Peña, Claudia Nuin, Irene Chesson, Andrew Safety evaluation of the food enzyme maltogenic amylase from genetically modified Escherichia coli (strain BLASC) |
title | Safety evaluation of the food enzyme maltogenic amylase from genetically modified Escherichia coli (strain BLASC) |
title_full | Safety evaluation of the food enzyme maltogenic amylase from genetically modified Escherichia coli (strain BLASC) |
title_fullStr | Safety evaluation of the food enzyme maltogenic amylase from genetically modified Escherichia coli (strain BLASC) |
title_full_unstemmed | Safety evaluation of the food enzyme maltogenic amylase from genetically modified Escherichia coli (strain BLASC) |
title_short | Safety evaluation of the food enzyme maltogenic amylase from genetically modified Escherichia coli (strain BLASC) |
title_sort | safety evaluation of the food enzyme maltogenic amylase from genetically modified escherichia coli (strain blasc) |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009224/ https://www.ncbi.nlm.nih.gov/pubmed/32626382 http://dx.doi.org/10.2903/j.efsa.2019.5769 |
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