Safety evaluation of the food enzyme glucan‐1,4‐α‐maltohydrolase from the genetically modified Bacillus subtilis strain AR‐453

Abstract The food enzyme glucan‐1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain AR‐453 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of...

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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, Lieve Herman, Yrjö Roos, Magdalena Andryszkiewicz, Yi Liu, Simone Lunardi, Andrew Chesson
Format: Article
Language:English
Published: Wiley 2023-07-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2023.8089
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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
Lieve Herman
Yrjö Roos
Magdalena Andryszkiewicz
Yi Liu
Simone Lunardi
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
Lieve Herman
Yrjö Roos
Magdalena Andryszkiewicz
Yi Liu
Simone Lunardi
Andrew Chesson
author_sort EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
collection DOAJ
description Abstract The food enzyme glucan‐1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain AR‐453 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 and its DNA. It is intended to be used in baking processes. Dietary exposure was estimated to be up to 0.262 mg TOS/kg body weight per day in European populations. As the production strain of B. subtilis strain AR‐453 qualifies for the qualified presumption of safety (QPS) approach to safety assessment and no issue of concern arose from the production process, no toxicological data were required. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and six matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood 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 doaj-art-2337fda0fc834087a3efc2a1bf0939e12025-08-20T02:27:32ZengWileyEFSA Journal1831-47322023-07-01217n/an/a10.2903/j.efsa.2023.8089Safety evaluation of the food enzyme glucan‐1,4‐α‐maltohydrolase from the genetically modified Bacillus subtilis strain AR‐453EFSA 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 ZornLieve HermanYrjö RoosMagdalena AndryszkiewiczYi LiuSimone LunardiAndrew ChessonAbstract The food enzyme glucan‐1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain AR‐453 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 and its DNA. It is intended to be used in baking processes. Dietary exposure was estimated to be up to 0.262 mg TOS/kg body weight per day in European populations. As the production strain of B. subtilis strain AR‐453 qualifies for the qualified presumption of safety (QPS) approach to safety assessment and no issue of concern arose from the production process, no toxicological data were required. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and six matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood 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.https://doi.org/10.2903/j.efsa.2023.8089food enzymeglucan 1,4‐α‐maltohydrolase4‐α‐d‐glucan α‐maltohydrolaseEC 3.2.1.133maltogenic α‐amylaseBacillus subtilis
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
Lieve Herman
Yrjö Roos
Magdalena Andryszkiewicz
Yi Liu
Simone Lunardi
Andrew Chesson
Safety evaluation of the food enzyme glucan‐1,4‐α‐maltohydrolase from the genetically modified Bacillus subtilis strain AR‐453
EFSA Journal
food enzyme
glucan 1,4‐α‐maltohydrolase
4‐α‐d‐glucan α‐maltohydrolase
EC 3.2.1.133
maltogenic α‐amylase
Bacillus subtilis
title Safety evaluation of the food enzyme glucan‐1,4‐α‐maltohydrolase from the genetically modified Bacillus subtilis strain AR‐453
title_full Safety evaluation of the food enzyme glucan‐1,4‐α‐maltohydrolase from the genetically modified Bacillus subtilis strain AR‐453
title_fullStr Safety evaluation of the food enzyme glucan‐1,4‐α‐maltohydrolase from the genetically modified Bacillus subtilis strain AR‐453
title_full_unstemmed Safety evaluation of the food enzyme glucan‐1,4‐α‐maltohydrolase from the genetically modified Bacillus subtilis strain AR‐453
title_short Safety evaluation of the food enzyme glucan‐1,4‐α‐maltohydrolase from the genetically modified Bacillus subtilis strain AR‐453
title_sort safety evaluation of the food enzyme glucan 1 4 α maltohydrolase from the genetically modified bacillus subtilis strain ar 453
topic food enzyme
glucan 1,4‐α‐maltohydrolase
4‐α‐d‐glucan α‐maltohydrolase
EC 3.2.1.133
maltogenic α‐amylase
Bacillus subtilis
url https://doi.org/10.2903/j.efsa.2023.8089
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