Safety evaluation of the food enzyme containing endo-polygalacturonase and endo-1,3(4)-beta-glucanase from the non-genetically modified Aspergillus fijiensis strain NZYM-RE

[EN] The food enzyme has two declared activities, endo-polygalacuronase ((1 & RARR;4)-alpha-D-galacturonan glycanohydrolase; EC 3.2.1.15) and endo-1,3(4)-beta-glucanase (3-(1 -> 3;1 -> 4)-beta-D-glucan 3(4)-glucanohydrolase; EC 3.2.1.6) and is produced with the non-genetically...

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Autores: Silano, Vittorio, 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:10251/194187
Acceso en línea:https://riunet.upv.es/handle/10251/194187
Access Level:acceso abierto
Palabra clave:Food enzyme
Endo-polygalacturonase
Endo-1,3(4)-beta-glucanase
EC 3.2.1.15
EC 3.2.1.6
Aspergillus fijiensis
TECNOLOGIA DE ALIMENTOS
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network_name_str España
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spelling Safety evaluation of the food enzyme containing endo-polygalacturonase and endo-1,3(4)-beta-glucanase from the non-genetically modified Aspergillus fijiensis strain NZYM-RESilano, VittorioBolognesi, ClaudiaCocconcelli, Pier SandroCrebelli, RiccardoGott, David MichaelGrob, KonradLampi, EvgeniaMengelers, MarcelMortensen, AlicjaRivière, GillesSteffensen, Inger-LiseTlustos, Christinavan Loveren, HenkVernis, LaurenceBarat Baviera, José Manuel|||0000-0001-8487-7114Food enzymeEndo-polygalacturonaseEndo-1,3(4)-beta-glucanaseEC 3.2.1.15EC 3.2.1.6Aspergillus fijiensisTECNOLOGIA DE ALIMENTOS[EN] The food enzyme has two declared activities, endo-polygalacuronase ((1 & RARR;4)-alpha-D-galacturonan glycanohydrolase; EC 3.2.1.15) and endo-1,3(4)-beta-glucanase (3-(1 -> 3;1 -> 4)-beta-D-glucan 3(4)-glucanohydrolase; EC 3.2.1.6) and is produced with the non-genetically modified Aspergillus fijiensis strain NZYM-RE by Novozymes A/S. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in eight food manufacturing processes, i.e. distilled alcohol production, brewing processes, baking processes, cereal-based processes, wine and wine vinegar production, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices and refined olive oil production. Since residual amounts of total organic solids (TOS) are removed during distilled alcohol production and refined olive oil production, dietary exposure was not calculated for these two processes. For the remaining six food manufacturing processes, dietary exposure was estimated to be up to 0.553 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 3,677 mg TOS/kg bw per day, the highest dose tested, resulting in a margin of exposure of at least 6,649. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and nine matches were found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by dietary exposure to this food enzyme, particularly in individuals suffering from the oral allergy syndrome or sensitised to papaya, cannot be excluded. 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 Riunet20222022-12-01journal articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://riunet.upv.es/handle/10251/194187reponame: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:10251/1941872026-06-13T07:49:27Z
dc.title.none.fl_str_mv Safety evaluation of the food enzyme containing endo-polygalacturonase and endo-1,3(4)-beta-glucanase from the non-genetically modified Aspergillus fijiensis strain NZYM-RE
title Safety evaluation of the food enzyme containing endo-polygalacturonase and endo-1,3(4)-beta-glucanase from the non-genetically modified Aspergillus fijiensis strain NZYM-RE
spellingShingle Safety evaluation of the food enzyme containing endo-polygalacturonase and endo-1,3(4)-beta-glucanase from the non-genetically modified Aspergillus fijiensis strain NZYM-RE
Silano, Vittorio
Food enzyme
Endo-polygalacturonase
Endo-1,3(4)-beta-glucanase
EC 3.2.1.15
EC 3.2.1.6
Aspergillus fijiensis
TECNOLOGIA DE ALIMENTOS
title_short Safety evaluation of the food enzyme containing endo-polygalacturonase and endo-1,3(4)-beta-glucanase from the non-genetically modified Aspergillus fijiensis strain NZYM-RE
title_full Safety evaluation of the food enzyme containing endo-polygalacturonase and endo-1,3(4)-beta-glucanase from the non-genetically modified Aspergillus fijiensis strain NZYM-RE
title_fullStr Safety evaluation of the food enzyme containing endo-polygalacturonase and endo-1,3(4)-beta-glucanase from the non-genetically modified Aspergillus fijiensis strain NZYM-RE
title_full_unstemmed Safety evaluation of the food enzyme containing endo-polygalacturonase and endo-1,3(4)-beta-glucanase from the non-genetically modified Aspergillus fijiensis strain NZYM-RE
title_sort Safety evaluation of the food enzyme containing endo-polygalacturonase and endo-1,3(4)-beta-glucanase from the non-genetically modified Aspergillus fijiensis strain NZYM-RE
dc.creator.none.fl_str_mv Silano, Vittorio
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 Silano, Vittorio
author_facet Silano, Vittorio
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
Endo-polygalacturonase
Endo-1,3(4)-beta-glucanase
EC 3.2.1.15
EC 3.2.1.6
Aspergillus fijiensis
TECNOLOGIA DE ALIMENTOS
topic Food enzyme
Endo-polygalacturonase
Endo-1,3(4)-beta-glucanase
EC 3.2.1.15
EC 3.2.1.6
Aspergillus fijiensis
TECNOLOGIA DE ALIMENTOS
description [EN] The food enzyme has two declared activities, endo-polygalacuronase ((1 & RARR;4)-alpha-D-galacturonan glycanohydrolase; EC 3.2.1.15) and endo-1,3(4)-beta-glucanase (3-(1 -> 3;1 -> 4)-beta-D-glucan 3(4)-glucanohydrolase; EC 3.2.1.6) and is produced with the non-genetically modified Aspergillus fijiensis strain NZYM-RE by Novozymes A/S. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in eight food manufacturing processes, i.e. distilled alcohol production, brewing processes, baking processes, cereal-based processes, wine and wine vinegar production, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices and refined olive oil production. Since residual amounts of total organic solids (TOS) are removed during distilled alcohol production and refined olive oil production, dietary exposure was not calculated for these two processes. For the remaining six food manufacturing processes, dietary exposure was estimated to be up to 0.553 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 3,677 mg TOS/kg bw per day, the highest dose tested, resulting in a margin of exposure of at least 6,649. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and nine matches were found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by dietary exposure to this food enzyme, particularly in individuals suffering from the oral allergy syndrome or sensitised to papaya, cannot be excluded. 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
2022-12-01
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/10251/194187
url https://riunet.upv.es/handle/10251/194187
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_ 1869423208800714752
score 15,300724

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