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Safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐FR

The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM‐FR by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for...

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Autores principales: Lambré, Claude, Manuel Barat Baviera, José, Bolognesi, Claudia, Sandro Cocconcelli, Pier, Crebelli, Riccardo, Michael Gott, David, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Andryszkiewicz, Magdalena, Arcella, Davide, 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/PMC9199875/
https://www.ncbi.nlm.nih.gov/pubmed/35757153
http://dx.doi.org/10.2903/j.efsa.2022.7367
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author Lambré, Claude
Manuel Barat Baviera, José
Bolognesi, Claudia
Sandro Cocconcelli, Pier
Crebelli, Riccardo
Michael Gott, David
Grob, Konrad
Lampi, Evgenia
Mengelers, Marcel
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
Van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Herman, Lieve
Andryszkiewicz, Magdalena
Arcella, Davide
Liu, Yi
Chesson, Andrew
author_facet Lambré, Claude
Manuel Barat Baviera, José
Bolognesi, Claudia
Sandro Cocconcelli, Pier
Crebelli, Riccardo
Michael Gott, David
Grob, Konrad
Lampi, Evgenia
Mengelers, Marcel
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
Van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Herman, Lieve
Andryszkiewicz, Magdalena
Arcella, Davide
Liu, Yi
Chesson, Andrew
collection PubMed
description The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM‐FR by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking and brewing processes and starch processing for glucose syrup production and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for the baking and brewing processes. Dietary exposure was estimated to be up to 0.30 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4‐α‐maltohydrolase produced with the genetically modified B. licheniformis strain NZYM‐FR does not give rise to safety concerns under the intended conditions of use.
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spelling pubmed-91998752022-06-23 Safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐FR Lambré, Claude Manuel Barat Baviera, José Bolognesi, Claudia Sandro Cocconcelli, Pier Crebelli, Riccardo Michael Gott, David Grob, Konrad Lampi, Evgenia Mengelers, Marcel Mortensen, Alicja Rivière, Gilles Steffensen, Inger‐Lise Tlustos, Christina Van Loveren, Henk Vernis, Laurence Zorn, Holger Herman, Lieve Andryszkiewicz, Magdalena Arcella, Davide Liu, Yi Chesson, Andrew EFSA J Scientific Opinion The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM‐FR by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking and brewing processes and starch processing for glucose syrup production and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for the baking and brewing processes. Dietary exposure was estimated to be up to 0.30 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4‐α‐maltohydrolase produced with the genetically modified B. licheniformis strain NZYM‐FR does not give rise to safety concerns under the intended conditions of use. John Wiley and Sons Inc. 2022-06-15 /pmc/articles/PMC9199875/ /pubmed/35757153 http://dx.doi.org/10.2903/j.efsa.2022.7367 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
Manuel Barat Baviera, José
Bolognesi, Claudia
Sandro Cocconcelli, Pier
Crebelli, Riccardo
Michael Gott, David
Grob, Konrad
Lampi, Evgenia
Mengelers, Marcel
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
Van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Herman, Lieve
Andryszkiewicz, Magdalena
Arcella, Davide
Liu, Yi
Chesson, Andrew
Safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐FR
title Safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐FR
title_full Safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐FR
title_fullStr Safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐FR
title_full_unstemmed Safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐FR
title_short Safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐FR
title_sort safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified bacillus licheniformis strain nzym‐fr
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9199875/
https://www.ncbi.nlm.nih.gov/pubmed/35757153
http://dx.doi.org/10.2903/j.efsa.2022.7367
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