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Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Trichoderma reesei strain NZYM‐ER

The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase; EC 3.2.1.8) is produced with the genetically modified Trichoderma reesei strain NZYM‐ER by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the produ...

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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, Herman, Lieve, Andryszkiewicz, Magdalena, Arcella, Davide, Kovalkovičová, Natália, Liu, Yi, 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/PMC9190295/
https://www.ncbi.nlm.nih.gov/pubmed/35734285
http://dx.doi.org/10.2903/j.efsa.2022.7373
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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
Andryszkiewicz, Magdalena
Arcella, Davide
Kovalkovičová, Natália
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
Andryszkiewicz, Magdalena
Arcella, Davide
Kovalkovičová, Natália
Liu, Yi
Chesson, Andrew
collection PubMed
description The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase; EC 3.2.1.8) is produced with the genetically modified Trichoderma reesei strain NZYM‐ER by Novozymes A/S. 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. The food enzyme is intended to be used in brewing processes, distilled alcohol production, grain treatment for the production of starch and gluten fractions and for palm oil production. Since residual amounts of total organic solids (TOS) are removed by distillation, in palm oil production and in grain treatment for the production of starch and gluten fraction, dietary exposure was only calculated for brewing processes. Dietary exposure to the food enzyme TOS was estimated to be up to 0.09 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 1,051 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 at least 11,400. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was 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.
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spelling pubmed-91902952022-06-21 Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Trichoderma reesei strain NZYM‐ER 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 Andryszkiewicz, Magdalena Arcella, Davide Kovalkovičová, Natália Liu, Yi Chesson, Andrew EFSA J Scientific Opinion The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase; EC 3.2.1.8) is produced with the genetically modified Trichoderma reesei strain NZYM‐ER by Novozymes A/S. 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. The food enzyme is intended to be used in brewing processes, distilled alcohol production, grain treatment for the production of starch and gluten fractions and for palm oil production. Since residual amounts of total organic solids (TOS) are removed by distillation, in palm oil production and in grain treatment for the production of starch and gluten fraction, dietary exposure was only calculated for brewing processes. Dietary exposure to the food enzyme TOS was estimated to be up to 0.09 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 1,051 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 at least 11,400. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was 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. 2022-06-13 /pmc/articles/PMC9190295/ /pubmed/35734285 http://dx.doi.org/10.2903/j.efsa.2022.7373 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
Andryszkiewicz, Magdalena
Arcella, Davide
Kovalkovičová, Natália
Liu, Yi
Chesson, Andrew
Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Trichoderma reesei strain NZYM‐ER
title Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Trichoderma reesei strain NZYM‐ER
title_full Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Trichoderma reesei strain NZYM‐ER
title_fullStr Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Trichoderma reesei strain NZYM‐ER
title_full_unstemmed Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Trichoderma reesei strain NZYM‐ER
title_short Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Trichoderma reesei strain NZYM‐ER
title_sort safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified trichoderma reesei strain nzym‐er
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9190295/
https://www.ncbi.nlm.nih.gov/pubmed/35734285
http://dx.doi.org/10.2903/j.efsa.2022.7373
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