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Safety evaluation of the food enzyme glucose oxidase from the genetically modified Trichoderma reesei strain AR‐352

The food enzyme glucose oxidase (β‐d‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with the genetically modified Trichoderma reesei strain AR‐352 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production...

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Autores principales: 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, Aguilera, Jaime, Andryszkiewicz, Magdalena, Nielsen, Elsa, Nørby, Karin, Liu, Yi, De Sousa, Rita Ferreira, Chesson, Andrew
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9332122/
https://www.ncbi.nlm.nih.gov/pubmed/35910422
http://dx.doi.org/10.2903/j.efsa.2022.7372
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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
Aguilera, Jaime
Andryszkiewicz, Magdalena
Nielsen, Elsa
Nørby, Karin
Liu, Yi
De Sousa, Rita Ferreira
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
Aguilera, Jaime
Andryszkiewicz, Magdalena
Nielsen, Elsa
Nørby, Karin
Liu, Yi
De Sousa, Rita Ferreira
Chesson, Andrew
collection PubMed
description The food enzyme glucose oxidase (β‐d‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with the genetically modified Trichoderma reesei strain AR‐352 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism, but the absence of its recombinant DNA could not be established. The food enzyme is intended to be used in four food manufacturing processes, namely baking processes, cereal‐based processes, grain treatment for the production of starch and gluten fractions, and egg processing. Since residual amounts of total organic solids (TOS) are removed by repeated washing during the production of starch and gluten, dietary exposure was calculated only for the remaining three processes. Dietary exposure to the food enzyme–TOS was estimated to be up to 0.13 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 1,000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of more than 7,800. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was 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 concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.
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spelling pubmed-93321222022-07-30 Safety evaluation of the food enzyme glucose oxidase from the genetically modified Trichoderma reesei strain AR‐352 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 Aguilera, Jaime Andryszkiewicz, Magdalena Nielsen, Elsa Nørby, Karin Liu, Yi De Sousa, Rita Ferreira Chesson, Andrew EFSA J Scientific Opinion The food enzyme glucose oxidase (β‐d‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with the genetically modified Trichoderma reesei strain AR‐352 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism, but the absence of its recombinant DNA could not be established. The food enzyme is intended to be used in four food manufacturing processes, namely baking processes, cereal‐based processes, grain treatment for the production of starch and gluten fractions, and egg processing. Since residual amounts of total organic solids (TOS) are removed by repeated washing during the production of starch and gluten, dietary exposure was calculated only for the remaining three processes. Dietary exposure to the food enzyme–TOS was estimated to be up to 0.13 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 1,000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of more than 7,800. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was 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 concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. John Wiley and Sons Inc. 2022-07-28 /pmc/articles/PMC9332122/ /pubmed/35910422 http://dx.doi.org/10.2903/j.efsa.2022.7372 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
Aguilera, Jaime
Andryszkiewicz, Magdalena
Nielsen, Elsa
Nørby, Karin
Liu, Yi
De Sousa, Rita Ferreira
Chesson, Andrew
Safety evaluation of the food enzyme glucose oxidase from the genetically modified Trichoderma reesei strain AR‐352
title Safety evaluation of the food enzyme glucose oxidase from the genetically modified Trichoderma reesei strain AR‐352
title_full Safety evaluation of the food enzyme glucose oxidase from the genetically modified Trichoderma reesei strain AR‐352
title_fullStr Safety evaluation of the food enzyme glucose oxidase from the genetically modified Trichoderma reesei strain AR‐352
title_full_unstemmed Safety evaluation of the food enzyme glucose oxidase from the genetically modified Trichoderma reesei strain AR‐352
title_short Safety evaluation of the food enzyme glucose oxidase from the genetically modified Trichoderma reesei strain AR‐352
title_sort safety evaluation of the food enzyme glucose oxidase from the genetically modified trichoderma reesei strain ar‐352
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9332122/
https://www.ncbi.nlm.nih.gov/pubmed/35910422
http://dx.doi.org/10.2903/j.efsa.2022.7372
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