Safety evaluation of the food enzyme glutaminase from the genetically modified Bacillus licheniformis strain NZYM‐JQ

Abstract The food enzyme glutaminase (l‐glutamine amidohydrolase EC 3.5.1.2) is produced with the genetically modified Bacillus licheniformis strain NZYM‐JQ by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The production strain met the requirements for the qualified p...

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Main Authors: EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Yrjö Roos, Magdalena Andryszkiewicz, Ana Criado, Ana Gomes, Yi Liu, Daniele Cavanna, Giulio diPiazza, Andrew Chesson
Format: Article
Language:English
Published: Wiley 2024-04-01
Series:EFSA Journal
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Online Access:https://doi.org/10.2903/j.efsa.2024.8711
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author EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
Claude Lambré
José Manuel Barat Baviera
Claudia Bolognesi
Pier Sandro Cocconcelli
Riccardo Crebelli
David Michael Gott
Konrad Grob
Evgenia Lampi
Marcel Mengelers
Alicja Mortensen
Gilles Rivière
Inger‐Lise Steffensen
Christina Tlustos
Henk Van Loveren
Laurence Vernis
Holger Zorn
Yrjö Roos
Magdalena Andryszkiewicz
Ana Criado
Ana Gomes
Yi Liu
Daniele Cavanna
Giulio diPiazza
Andrew Chesson
author_facet EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
Claude Lambré
José Manuel Barat Baviera
Claudia Bolognesi
Pier Sandro Cocconcelli
Riccardo Crebelli
David Michael Gott
Konrad Grob
Evgenia Lampi
Marcel Mengelers
Alicja Mortensen
Gilles Rivière
Inger‐Lise Steffensen
Christina Tlustos
Henk Van Loveren
Laurence Vernis
Holger Zorn
Yrjö Roos
Magdalena Andryszkiewicz
Ana Criado
Ana Gomes
Yi Liu
Daniele Cavanna
Giulio diPiazza
Andrew Chesson
author_sort EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
collection DOAJ
description Abstract The food enzyme glutaminase (l‐glutamine amidohydrolase EC 3.5.1.2) is produced with the genetically modified Bacillus licheniformis strain NZYM‐JQ by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The production strain met the requirements for the qualified presumption of safety (QPS). The food enzyme is free from viable cells of the production organism and its DNA. The enzyme under assessment is intended to be used in six food manufacturing processes. Dietary exposure was estimated to be up to 0.148 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concern resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. A search was made for the similarity of the amino acid sequence to those of known allergens and one match with a pollen allergen was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, particularly for individuals sensitised to birch and oak pollen. The Panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use.
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spelling doaj-art-8cde6ac1ac954dd5baf681e47c6955d52025-07-03T09:56:06ZengWileyEFSA Journal1831-47322024-04-01224n/an/a10.2903/j.efsa.2024.8711Safety evaluation of the food enzyme glutaminase from the genetically modified Bacillus licheniformis strain NZYM‐JQEFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)Claude LambréJosé Manuel Barat BavieraClaudia BolognesiPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiMarcel MengelersAlicja MortensenGilles RivièreInger‐Lise SteffensenChristina TlustosHenk Van LoverenLaurence VernisHolger ZornYrjö RoosMagdalena AndryszkiewiczAna CriadoAna GomesYi LiuDaniele CavannaGiulio diPiazzaAndrew ChessonAbstract The food enzyme glutaminase (l‐glutamine amidohydrolase EC 3.5.1.2) is produced with the genetically modified Bacillus licheniformis strain NZYM‐JQ by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The production strain met the requirements for the qualified presumption of safety (QPS). The food enzyme is free from viable cells of the production organism and its DNA. The enzyme under assessment is intended to be used in six food manufacturing processes. Dietary exposure was estimated to be up to 0.148 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concern resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. A search was made for the similarity of the amino acid sequence to those of known allergens and one match with a pollen allergen was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, particularly for individuals sensitised to birch and oak pollen. The Panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use.https://doi.org/10.2903/j.efsa.2024.8711Bacillus licheniformisEC 3.5.1.2food enzymegenetically modified microorganismglutaminasel‐glutaminase
spellingShingle EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
Claude Lambré
José Manuel Barat Baviera
Claudia Bolognesi
Pier Sandro Cocconcelli
Riccardo Crebelli
David Michael Gott
Konrad Grob
Evgenia Lampi
Marcel Mengelers
Alicja Mortensen
Gilles Rivière
Inger‐Lise Steffensen
Christina Tlustos
Henk Van Loveren
Laurence Vernis
Holger Zorn
Yrjö Roos
Magdalena Andryszkiewicz
Ana Criado
Ana Gomes
Yi Liu
Daniele Cavanna
Giulio diPiazza
Andrew Chesson
Safety evaluation of the food enzyme glutaminase from the genetically modified Bacillus licheniformis strain NZYM‐JQ
EFSA Journal
Bacillus licheniformis
EC 3.5.1.2
food enzyme
genetically modified microorganism
glutaminase
l‐glutaminase
title Safety evaluation of the food enzyme glutaminase from the genetically modified Bacillus licheniformis strain NZYM‐JQ
title_full Safety evaluation of the food enzyme glutaminase from the genetically modified Bacillus licheniformis strain NZYM‐JQ
title_fullStr Safety evaluation of the food enzyme glutaminase from the genetically modified Bacillus licheniformis strain NZYM‐JQ
title_full_unstemmed Safety evaluation of the food enzyme glutaminase from the genetically modified Bacillus licheniformis strain NZYM‐JQ
title_short Safety evaluation of the food enzyme glutaminase from the genetically modified Bacillus licheniformis strain NZYM‐JQ
title_sort safety evaluation of the food enzyme glutaminase from the genetically modified bacillus licheniformis strain nzym jq
topic Bacillus licheniformis
EC 3.5.1.2
food enzyme
genetically modified microorganism
glutaminase
l‐glutaminase
url https://doi.org/10.2903/j.efsa.2024.8711
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