Safety evaluation of the food enzyme endo-1,4-beta-xylanase from the genetically modified Bacillus subtilis strain DP-Ezd31

[EN] The food enzyme endo-1,4-ß-xylanase (4-ß-d-xylan xylanohydrolase; EC 3.2.1.8) is produced with a genetically modified Bacillus subtilis strain DP-Ezd31 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. However, based o...

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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:2021
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:10251/185446
Acceso en línea:https://riunet.upv.es/handle/10251/185446
Access Level:acceso abierto
Palabra clave:Food enzyme
EC 3.2.1.8
Eendo-1
4-beta-xylanase
Xylanase
Bacillus subtilis
Genetically modified microorganism
TECNOLOGIA DE ALIMENTOS
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spelling Safety evaluation of the food enzyme endo-1,4-beta-xylanase from the genetically modified Bacillus subtilis strain DP-Ezd31Lambré, 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 enzymeEC 3.2.1.8Eendo-14-beta-xylanaseXylanaseBacillus subtilisGenetically modified microorganismTECNOLOGIA DE ALIMENTOS[EN] The food enzyme endo-1,4-ß-xylanase (4-ß-d-xylan xylanohydrolase; EC 3.2.1.8) is produced with a genetically modified Bacillus subtilis strain DP-Ezd31 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a safety concern. The production strain was not shown to meet the criteria for Qualified Presumption of Safety (QPS) approach to safety assessment. The substitute studies provided were not considered suitable for the toxicological assessment of this food enzyme. A search for similarity of the amino acid sequence to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, 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. In the absence of suitable toxicological studies, the Panel cannot conclude on the safety of the food enzyme.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 Riunet20212021-04-01journal articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://riunet.upv.es/handle/10251/185446reponame: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:10251/1854462026-06-13T07:49:27Z
dc.title.none.fl_str_mv Safety evaluation of the food enzyme endo-1,4-beta-xylanase from the genetically modified Bacillus subtilis strain DP-Ezd31
title Safety evaluation of the food enzyme endo-1,4-beta-xylanase from the genetically modified Bacillus subtilis strain DP-Ezd31
spellingShingle Safety evaluation of the food enzyme endo-1,4-beta-xylanase from the genetically modified Bacillus subtilis strain DP-Ezd31
Lambré, Claude
Food enzyme
EC 3.2.1.8
Eendo-1
4-beta-xylanase
Xylanase
Bacillus subtilis
Genetically modified microorganism
TECNOLOGIA DE ALIMENTOS
title_short Safety evaluation of the food enzyme endo-1,4-beta-xylanase from the genetically modified Bacillus subtilis strain DP-Ezd31
title_full Safety evaluation of the food enzyme endo-1,4-beta-xylanase from the genetically modified Bacillus subtilis strain DP-Ezd31
title_fullStr Safety evaluation of the food enzyme endo-1,4-beta-xylanase from the genetically modified Bacillus subtilis strain DP-Ezd31
title_full_unstemmed Safety evaluation of the food enzyme endo-1,4-beta-xylanase from the genetically modified Bacillus subtilis strain DP-Ezd31
title_sort Safety evaluation of the food enzyme endo-1,4-beta-xylanase from the genetically modified Bacillus subtilis strain DP-Ezd31
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
EC 3.2.1.8
Eendo-1
4-beta-xylanase
Xylanase
Bacillus subtilis
Genetically modified microorganism
TECNOLOGIA DE ALIMENTOS
topic Food enzyme
EC 3.2.1.8
Eendo-1
4-beta-xylanase
Xylanase
Bacillus subtilis
Genetically modified microorganism
TECNOLOGIA DE ALIMENTOS
description [EN] The food enzyme endo-1,4-ß-xylanase (4-ß-d-xylan xylanohydrolase; EC 3.2.1.8) is produced with a genetically modified Bacillus subtilis strain DP-Ezd31 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a safety concern. The production strain was not shown to meet the criteria for Qualified Presumption of Safety (QPS) approach to safety assessment. The substitute studies provided were not considered suitable for the toxicological assessment of this food enzyme. A search for similarity of the amino acid sequence to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, 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. In the absence of suitable toxicological studies, the Panel cannot conclude on the safety of the food enzyme.
publishDate 2021
dc.date.none.fl_str_mv 2021
2021-04-01
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/10251/185446
url https://riunet.upv.es/handle/10251/185446
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_ 1869411018338205696
score 15.300719