Safety evaluation of the food enzyme glucan 1,4-alpha-glucosidase from the genetically modified Aspergillus niger strain NZYM-BE

[EN] The food enzyme glucan 1,4-alpha-glucosidase (4-alpha-D-glucan glucohydrolase EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM-BE by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme was free from viable cells of the...

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Autores: Lambré, Claude, 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, Barat Baviera, José Manuel|||0000-0001-8487-7114
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Universitat Politècnica de València (UPV)
Repositorio:RiuNet. Repositorio Institucional de la Universitat Politécnica de Valéncia
Idioma:inglés
OAI Identifier:oai:riunet.upv.es:10251/193849
Acceso en línea:https://riunet.upv.es/handle/10251/193849
Access Level:acceso abierto
Palabra clave:Food enzyme
Glucan 1,4-alpha-glucosidase
4-alpha-D-glucan glucohydrolase
EC 3.2.1.3
Glucomylase
Aspergillus niger
Genetically modified microorganism
TECNOLOGIA DE ALIMENTOS
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spelling Safety evaluation of the food enzyme glucan 1,4-alpha-glucosidase from the genetically modified Aspergillus niger strain NZYM-BELambré, ClaudeBolognesi, ClaudiaCocconcelli, Pier SandroCrebelli, RiccardoGott, David MichaelGrob, KonradLampi, EvgeniaMengelers, MarcelMortensen, AlicjaRivière, GillesSteffensen, Inger-LiseTlustos, Christinavan Loveren, HenkVernis, LaurenceBarat Baviera, José Manuel|||0000-0001-8487-7114Food enzymeGlucan 1,4-alpha-glucosidase4-alpha-D-glucan glucohydrolaseEC 3.2.1.3GlucomylaseAspergillus nigerGenetically modified microorganismTECNOLOGIA DE ALIMENTOS[EN] The food enzyme glucan 1,4-alpha-glucosidase (4-alpha-D-glucan glucohydrolase EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM-BE by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme was free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in six food manufacturing processes, namely starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production, brewing processes, baking processes, cereal-based processes, and fruit and vegetable processing for juice production. Since residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied to produce glucose syrups, dietary exposure was not calculated for these two food processes. For the remaining four processes, dietary exposure to the food enzyme-TOS was estimated to be up to 7.7 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise 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 of 3,795 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 490. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched for and one match found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production) the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be 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.WilleyDepartamento de Tecnología de AlimentosInstituto Universitario de Ingeniería de Alimentos (FoodUPV)Escuela Técnica Superior de Ingeniería Agronómica y del Medio NaturalGrupo de Investigación e Innovación AlimentariaRepositorio Institucional de la Universitat Politècnica de València Riunet20222022-06-01journal articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://riunet.upv.es/handle/10251/193849reponame:RiuNet. Repositorio Institucional de la Universitat Politécnica de Valénciainstname:Universitat Politècnica de València (UPV)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Reconocimiento - Sin obra derivada (by-nd) http://creativecommons.org/licenses/by-nd/4.0/info:eu-repo/semantics/openAccessoai:riunet.upv.es:10251/1938492026-06-13T07:49:27Z
dc.title.none.fl_str_mv Safety evaluation of the food enzyme glucan 1,4-alpha-glucosidase from the genetically modified Aspergillus niger strain NZYM-BE
title Safety evaluation of the food enzyme glucan 1,4-alpha-glucosidase from the genetically modified Aspergillus niger strain NZYM-BE
spellingShingle Safety evaluation of the food enzyme glucan 1,4-alpha-glucosidase from the genetically modified Aspergillus niger strain NZYM-BE
Lambré, Claude
Food enzyme
Glucan 1,4-alpha-glucosidase
4-alpha-D-glucan glucohydrolase
EC 3.2.1.3
Glucomylase
Aspergillus niger
Genetically modified microorganism
TECNOLOGIA DE ALIMENTOS
title_short Safety evaluation of the food enzyme glucan 1,4-alpha-glucosidase from the genetically modified Aspergillus niger strain NZYM-BE
title_full Safety evaluation of the food enzyme glucan 1,4-alpha-glucosidase from the genetically modified Aspergillus niger strain NZYM-BE
title_fullStr Safety evaluation of the food enzyme glucan 1,4-alpha-glucosidase from the genetically modified Aspergillus niger strain NZYM-BE
title_full_unstemmed Safety evaluation of the food enzyme glucan 1,4-alpha-glucosidase from the genetically modified Aspergillus niger strain NZYM-BE
title_sort Safety evaluation of the food enzyme glucan 1,4-alpha-glucosidase from the genetically modified Aspergillus niger strain NZYM-BE
dc.creator.none.fl_str_mv Lambré, Claude
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
Barat Baviera, José Manuel|||0000-0001-8487-7114
author Lambré, Claude
author_facet Lambré, Claude
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
Barat Baviera, José Manuel|||0000-0001-8487-7114
author_role author
author2 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
Barat Baviera, José Manuel|||0000-0001-8487-7114
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Departamento de Tecnología de Alimentos
Instituto Universitario de Ingeniería de Alimentos (FoodUPV)
Escuela Técnica Superior de Ingeniería Agronómica y del Medio Natural
Grupo de Investigación e Innovación Alimentaria
Repositorio Institucional de la Universitat Politècnica de València Riunet
dc.subject.none.fl_str_mv Food enzyme
Glucan 1,4-alpha-glucosidase
4-alpha-D-glucan glucohydrolase
EC 3.2.1.3
Glucomylase
Aspergillus niger
Genetically modified microorganism
TECNOLOGIA DE ALIMENTOS
topic Food enzyme
Glucan 1,4-alpha-glucosidase
4-alpha-D-glucan glucohydrolase
EC 3.2.1.3
Glucomylase
Aspergillus niger
Genetically modified microorganism
TECNOLOGIA DE ALIMENTOS
description [EN] The food enzyme glucan 1,4-alpha-glucosidase (4-alpha-D-glucan glucohydrolase EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM-BE by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme was free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in six food manufacturing processes, namely starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production, brewing processes, baking processes, cereal-based processes, and fruit and vegetable processing for juice production. Since residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied to produce glucose syrups, dietary exposure was not calculated for these two food processes. For the remaining four processes, dietary exposure to the food enzyme-TOS was estimated to be up to 7.7 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise 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 of 3,795 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 490. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched for and one match found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production) the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be 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.
publishDate 2022
dc.date.none.fl_str_mv 2022
2022-06-01
dc.type.none.fl_str_mv journal article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://riunet.upv.es/handle/10251/193849
url https://riunet.upv.es/handle/10251/193849
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Reconocimiento - Sin obra derivada (by-nd)
http://creativecommons.org/licenses/by-nd/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Reconocimiento - Sin obra derivada (by-nd)
http://creativecommons.org/licenses/by-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Willey
publisher.none.fl_str_mv Willey
dc.source.none.fl_str_mv reponame:RiuNet. Repositorio Institucional de la Universitat Politécnica de Valéncia
instname:Universitat Politècnica de València (UPV)
instname_str Universitat Politècnica de València (UPV)
reponame_str RiuNet. Repositorio Institucional de la Universitat Politécnica de Valéncia
collection RiuNet. Repositorio Institucional de la Universitat Politécnica de Valéncia
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869419856949936128
score 15,300719

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