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Safety evaluation of the food enzyme inulinase from the genetically modified Aspergillus oryzae strain MUCL 44346

The food enzyme inulinase (1‐β‐d‐fructan fructanohydrolase; EC 3.2.1.7) is produced with the genetically modified Aspergillus oryzae strain MUCL 44346 by PURATOS NV. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism an...

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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, Herman, Lieve, Roos, Yrjö, Aguilera, Jaime, Andryszkiewicz, Magdalena, Arcella, Davide, Kovalkovičová, Natália, Liu, Yi, Peña, Claudia Roncancio, Chesson, Andrew
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10370325/
https://www.ncbi.nlm.nih.gov/pubmed/37502015
http://dx.doi.org/10.2903/j.efsa.2023.8148
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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
Herman, Lieve
Roos, Yrjö
Aguilera, Jaime
Andryszkiewicz, Magdalena
Arcella, Davide
Kovalkovičová, Natália
Liu, Yi
Peña, Claudia Roncancio
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
Herman, Lieve
Roos, Yrjö
Aguilera, Jaime
Andryszkiewicz, Magdalena
Arcella, Davide
Kovalkovičová, Natália
Liu, Yi
Peña, Claudia Roncancio
Chesson, Andrew
collection PubMed
description The food enzyme inulinase (1‐β‐d‐fructan fructanohydrolase; EC 3.2.1.7) is produced with the genetically modified Aspergillus oryzae strain MUCL 44346 by PURATOS NV. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in the production of fructo‐oligosaccharides (FOS) from inulin extracted from chicory roots. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.01 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 (NOAEL) of 100 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 10,000. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches were found with tomato allergens. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to tomato, cannot be excluded. However, the likelihood of allergic reactions is expected not to exceed the likelihood of allergic reactions to tomato. As the prevalence of allergic reactions to tomato is low, also the likelihood of such reactions to occur to the food enzyme is 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-103703252023-07-27 Safety evaluation of the food enzyme inulinase from the genetically modified Aspergillus oryzae strain MUCL 44346 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 Herman, Lieve Roos, Yrjö Aguilera, Jaime Andryszkiewicz, Magdalena Arcella, Davide Kovalkovičová, Natália Liu, Yi Peña, Claudia Roncancio Chesson, Andrew EFSA J Scientific Opinion The food enzyme inulinase (1‐β‐d‐fructan fructanohydrolase; EC 3.2.1.7) is produced with the genetically modified Aspergillus oryzae strain MUCL 44346 by PURATOS NV. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in the production of fructo‐oligosaccharides (FOS) from inulin extracted from chicory roots. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.01 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 (NOAEL) of 100 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 10,000. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches were found with tomato allergens. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to tomato, cannot be excluded. However, the likelihood of allergic reactions is expected not to exceed the likelihood of allergic reactions to tomato. As the prevalence of allergic reactions to tomato is low, also the likelihood of such reactions to occur to the food enzyme is 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. 2023-07-26 /pmc/articles/PMC10370325/ /pubmed/37502015 http://dx.doi.org/10.2903/j.efsa.2023.8148 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
Herman, Lieve
Roos, Yrjö
Aguilera, Jaime
Andryszkiewicz, Magdalena
Arcella, Davide
Kovalkovičová, Natália
Liu, Yi
Peña, Claudia Roncancio
Chesson, Andrew
Safety evaluation of the food enzyme inulinase from the genetically modified Aspergillus oryzae strain MUCL 44346
title Safety evaluation of the food enzyme inulinase from the genetically modified Aspergillus oryzae strain MUCL 44346
title_full Safety evaluation of the food enzyme inulinase from the genetically modified Aspergillus oryzae strain MUCL 44346
title_fullStr Safety evaluation of the food enzyme inulinase from the genetically modified Aspergillus oryzae strain MUCL 44346
title_full_unstemmed Safety evaluation of the food enzyme inulinase from the genetically modified Aspergillus oryzae strain MUCL 44346
title_short Safety evaluation of the food enzyme inulinase from the genetically modified Aspergillus oryzae strain MUCL 44346
title_sort safety evaluation of the food enzyme inulinase from the genetically modified aspergillus oryzae strain mucl 44346
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10370325/
https://www.ncbi.nlm.nih.gov/pubmed/37502015
http://dx.doi.org/10.2903/j.efsa.2023.8148
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