Safety evaluation of the food enzyme B-galactosidase from the non-genetically modified Papiliotrema terrestris strain AE-BLC

[EN] The food enzyme beta-galactosidase (beta-d-galactoside galactohydrolase; EC 3.2.1.23) is produced with the non-genetically modified Papiliotrema terrestris strain AE-BLC by Amano Enzyme Inc. The food enzyme was considered free from viable cells of the production organism. It is intended to be u...

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Autores: Lambré, Claude, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David M, Grob, Konrad, Lampi, Eugenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger-Lise, Tlustos, Christina, Loveren, Henk van, Vernis, Laurence, Barat Baviera, José Manuel|||0000-0001-8487-7114
Tipo de recurso: artículo
Fecha de publicación:2024
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:10251/224152
Acceso en línea:https://riunet.upv.es/handle/10251/224152
Access Level:acceso abierto
Palabra clave:EC 3.2.1.23
Food enzyme
Lactase
Papiliotrema terrestris
Beta-d-galactoside galactohydrolase
Beta-Galactosidase
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network_acronym_str ES
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repository_id_str
spelling Safety evaluation of the food enzyme B-galactosidase from the non-genetically modified Papiliotrema terrestris strain AE-BLCLambré, ClaudeBolognesi, ClaudiaCocconcelli, Pier SandroCrebelli, RiccardoGott, David MGrob, KonradLampi, EugeniaMengelers, MarcelMortensen, AlicjaRivière, GillesSteffensen, Inger-LiseTlustos, ChristinaLoveren, Henk vanVernis, LaurenceBarat Baviera, José Manuel|||0000-0001-8487-7114EC 3.2.1.23Food enzymeLactasePapiliotrema terrestrisBeta-d-galactoside galactohydrolaseBeta-Galactosidase[EN] The food enzyme beta-galactosidase (beta-d-galactoside galactohydrolase; EC 3.2.1.23) is produced with the non-genetically modified Papiliotrema terrestris strain AE-BLC by Amano Enzyme Inc. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in the production of galacto-oligosaccharides (GOS) from lactose. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.441 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 1800 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 4082. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme 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.WileyDepartamento 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 Riunet20242024-01-01journal articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://riunet.upv.es/handle/10251/224152reponame: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:10251/2241522026-06-13T07:49:27Z
dc.title.none.fl_str_mv Safety evaluation of the food enzyme B-galactosidase from the non-genetically modified Papiliotrema terrestris strain AE-BLC
title Safety evaluation of the food enzyme B-galactosidase from the non-genetically modified Papiliotrema terrestris strain AE-BLC
spellingShingle Safety evaluation of the food enzyme B-galactosidase from the non-genetically modified Papiliotrema terrestris strain AE-BLC
Lambré, Claude
EC 3.2.1.23
Food enzyme
Lactase
Papiliotrema terrestris
Beta-d-galactoside galactohydrolase
Beta-Galactosidase
title_short Safety evaluation of the food enzyme B-galactosidase from the non-genetically modified Papiliotrema terrestris strain AE-BLC
title_full Safety evaluation of the food enzyme B-galactosidase from the non-genetically modified Papiliotrema terrestris strain AE-BLC
title_fullStr Safety evaluation of the food enzyme B-galactosidase from the non-genetically modified Papiliotrema terrestris strain AE-BLC
title_full_unstemmed Safety evaluation of the food enzyme B-galactosidase from the non-genetically modified Papiliotrema terrestris strain AE-BLC
title_sort Safety evaluation of the food enzyme B-galactosidase from the non-genetically modified Papiliotrema terrestris strain AE-BLC
dc.creator.none.fl_str_mv Lambré, Claude
Bolognesi, Claudia
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David M
Grob, Konrad
Lampi, Eugenia
Mengelers, Marcel
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger-Lise
Tlustos, Christina
Loveren, Henk van
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 M
Grob, Konrad
Lampi, Eugenia
Mengelers, Marcel
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger-Lise
Tlustos, Christina
Loveren, Henk van
Vernis, Laurence
Barat Baviera, José Manuel|||0000-0001-8487-7114
author_role author
author2 Bolognesi, Claudia
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David M
Grob, Konrad
Lampi, Eugenia
Mengelers, Marcel
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger-Lise
Tlustos, Christina
Loveren, Henk van
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 EC 3.2.1.23
Food enzyme
Lactase
Papiliotrema terrestris
Beta-d-galactoside galactohydrolase
Beta-Galactosidase
topic EC 3.2.1.23
Food enzyme
Lactase
Papiliotrema terrestris
Beta-d-galactoside galactohydrolase
Beta-Galactosidase
description [EN] The food enzyme beta-galactosidase (beta-d-galactoside galactohydrolase; EC 3.2.1.23) is produced with the non-genetically modified Papiliotrema terrestris strain AE-BLC by Amano Enzyme Inc. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in the production of galacto-oligosaccharides (GOS) from lactose. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.441 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 1800 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 4082. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme 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.
publishDate 2024
dc.date.none.fl_str_mv 2024
2024-01-01
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/10251/224152
url https://riunet.upv.es/handle/10251/224152
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 Wiley
publisher.none.fl_str_mv Wiley
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
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score 15.812429

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