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Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

The food enzyme 4‐α‐glucanotransferase (1,4‐α‐d‐glucan:1,4‐α‐d‐glucan 4‐α‐d‐glycosyltransferase, EC 2.4.1.25) is produced with a non‐genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baki...

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Autores principales: Silano, Vittorio, Barat Baviera, José Manuel, Bolognesi, Claudia, Brüschweiler, Beat Johannes, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Glandorf, Boet, Herman, Lieve, Aguilera, Jaime, Andryszkiewicz, Magdalena, Arcella, Davide, Liu, Yi, Maia, Joaquim, Chesson, Andrew
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009276/
https://www.ncbi.nlm.nih.gov/pubmed/32626254
http://dx.doi.org/10.2903/j.efsa.2019.5628
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author Silano, Vittorio
Barat Baviera, José Manuel
Bolognesi, Claudia
Brüschweiler, Beat Johannes
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lampi, Evgenia
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Glandorf, Boet
Herman, Lieve
Aguilera, Jaime
Andryszkiewicz, Magdalena
Arcella, Davide
Liu, Yi
Maia, Joaquim
Chesson, Andrew
author_facet Silano, Vittorio
Barat Baviera, José Manuel
Bolognesi, Claudia
Brüschweiler, Beat Johannes
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lampi, Evgenia
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Glandorf, Boet
Herman, Lieve
Aguilera, Jaime
Andryszkiewicz, Magdalena
Arcella, Davide
Liu, Yi
Maia, Joaquim
Chesson, Andrew
collection PubMed
description The food enzyme 4‐α‐glucanotransferase (1,4‐α‐d‐glucan:1,4‐α‐d‐glucan 4‐α‐d‐glycosyltransferase, EC 2.4.1.25) is produced with a non‐genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baking processes and in starch processing for the production of modified dextrins. For baking processes, based on the maximum use levels recommended and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 0.050 mg TOS/kg body weight (bw) per day. Exposure assessment for the modified dextrins was not considered necessary. Genotoxicity tests did not raise a safety concern. Systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. From this study, the Panel identified a no observed adverse effect level (NOAEL) of at least 900 mg TOS/kg bw per day, the highest dose tested. When the NOAEL value is compared to the estimated dietary exposure to the food enzyme used in baking, this results in a Margin of Exposure (MOE) of at least 18,000. The Panel considers that any additional exposure to the food enzyme from the use of modified dextrins will be covered by the above MOE. A search was made for similarity of the amino acid sequence of the food enzyme with those of known allergens. One match was found with a known respiratory allergen, an α‐amylase. The Panel considered that an allergic reaction upon oral ingestion of 4‐α‐glucanotransferase produced by A. pallidus AE‐SAS in individuals respiratory sensitised to α‐amylase cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that, under the intended conditions of use and based on the data provided, this food enzyme does not give rise to safety concerns.
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spelling pubmed-70092762020-07-02 Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS) Silano, Vittorio Barat Baviera, José Manuel Bolognesi, Claudia Brüschweiler, Beat Johannes Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mortensen, Alicja Rivière, Gilles Steffensen, Inger‐Lise Tlustos, Christina van Loveren, Henk Vernis, Laurence Zorn, Holger Glandorf, Boet Herman, Lieve Aguilera, Jaime Andryszkiewicz, Magdalena Arcella, Davide Liu, Yi Maia, Joaquim Chesson, Andrew EFSA J Scientific Opinion The food enzyme 4‐α‐glucanotransferase (1,4‐α‐d‐glucan:1,4‐α‐d‐glucan 4‐α‐d‐glycosyltransferase, EC 2.4.1.25) is produced with a non‐genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baking processes and in starch processing for the production of modified dextrins. For baking processes, based on the maximum use levels recommended and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 0.050 mg TOS/kg body weight (bw) per day. Exposure assessment for the modified dextrins was not considered necessary. Genotoxicity tests did not raise a safety concern. Systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. From this study, the Panel identified a no observed adverse effect level (NOAEL) of at least 900 mg TOS/kg bw per day, the highest dose tested. When the NOAEL value is compared to the estimated dietary exposure to the food enzyme used in baking, this results in a Margin of Exposure (MOE) of at least 18,000. The Panel considers that any additional exposure to the food enzyme from the use of modified dextrins will be covered by the above MOE. A search was made for similarity of the amino acid sequence of the food enzyme with those of known allergens. One match was found with a known respiratory allergen, an α‐amylase. The Panel considered that an allergic reaction upon oral ingestion of 4‐α‐glucanotransferase produced by A. pallidus AE‐SAS in individuals respiratory sensitised to α‐amylase cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that, under the intended conditions of use and based on the data provided, this food enzyme does not give rise to safety concerns. John Wiley and Sons Inc. 2019-03-08 /pmc/articles/PMC7009276/ /pubmed/32626254 http://dx.doi.org/10.2903/j.efsa.2019.5628 Text en © 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://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
Silano, Vittorio
Barat Baviera, José Manuel
Bolognesi, Claudia
Brüschweiler, Beat Johannes
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lampi, Evgenia
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Glandorf, Boet
Herman, Lieve
Aguilera, Jaime
Andryszkiewicz, Magdalena
Arcella, Davide
Liu, Yi
Maia, Joaquim
Chesson, Andrew
Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)
title Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)
title_full Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)
title_fullStr Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)
title_full_unstemmed Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)
title_short Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)
title_sort safety evaluation of the food enzyme 4‐α‐glucanotransferase from aeribacillus pallidus (strain ae‐sas)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009276/
https://www.ncbi.nlm.nih.gov/pubmed/32626254
http://dx.doi.org/10.2903/j.efsa.2019.5628
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