Safety evaluation of the food enzyme subtilisin from the non-genetically modified Bacillus paralicheniformis strain AP-01

[EN] The food enzyme subtilisin (EC 3.4.21.62) is produced with the non-genetically modified Bacillus paralicheniformis strain AP-01 by Nagase (Europa) GmbH. It was considered free from viable cells of the production organism. The food enzyme is intended to be used in five food manufacturing process...

Descripción completa

Detalles Bibliográficos
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:10251/224406
Acceso en línea:https://riunet.upv.es/handle/10251/224406
Access Level:acceso abierto
Palabra clave:Bacillus paralicheniformis
EC 3.4.21.62
Serine endopeptidase
Subtilisin
id ES_226cd8d0223a8b355164fcc57bd2e83f
oai_identifier_str oai:riunet.upv.es:10251/224406
network_acronym_str ES
network_name_str España
repository_id_str
spelling Safety evaluation of the food enzyme subtilisin from the non-genetically modified Bacillus paralicheniformis strain AP-01Lambré, ClaudeBolognesi, ClaudiaCocconcelli, Pier SandroCrebelli, RiccardoGott, David MGrob, KonradLampi, EugeniaMengelers, MarcelMortensen, AlicjaRivière, GillesSteffensen, Inger-LiseTlustos, ChristinaLoveren, Henk vanVernis, LaurenceBarat Baviera, José Manuel|||0000-0001-8487-7114Bacillus paralicheniformisEC 3.4.21.62Serine endopeptidaseSubtilisin[EN] The food enzyme subtilisin (EC 3.4.21.62) is produced with the non-genetically modified Bacillus paralicheniformis strain AP-01 by Nagase (Europa) GmbH. It was considered free from viable cells of the production organism. The food enzyme is intended to be used in five food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in one process, dietary exposure was calculated only for the remaining four food manufacturing processes. It was estimated to be up to 0.875 mg TOS/kg body weight per day in European populations. The production strain of the food enzyme has the capacity to produce bacitracin and thus failed to meet the requirements of the Qualified Presumption of Safety approach. Bacitracin was detected in the industrial fermentation medium but not in the food enzyme itself. However, the limit of detection of the analytical method used for bacitracin was not sufficient to exclude the possible presence of bacitracin at a level representing a risk for the development of antimicrobial resistant bacteria. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and twenty-eight matches with respiratory allergens, one match with a contact allergen and two matches with food allergens (melon and pomegranate) were found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to melon or pomegranate, cannot be excluded, but would not exceed the risk of consuming melon or pomegranate. Based on the data provided, the Panel could not exclude the presence of bacitracin, a medically important antimicrobial, and consequently the safety of this food enzyme could not be established.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 Riunet20242024-07-31journal articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://riunet.upv.es/handle/10251/224406reponame: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:10251/2244062026-06-13T07:49:27Z
dc.title.none.fl_str_mv Safety evaluation of the food enzyme subtilisin from the non-genetically modified Bacillus paralicheniformis strain AP-01
title Safety evaluation of the food enzyme subtilisin from the non-genetically modified Bacillus paralicheniformis strain AP-01
spellingShingle Safety evaluation of the food enzyme subtilisin from the non-genetically modified Bacillus paralicheniformis strain AP-01
Lambré, Claude
Bacillus paralicheniformis
EC 3.4.21.62
Serine endopeptidase
Subtilisin
title_short Safety evaluation of the food enzyme subtilisin from the non-genetically modified Bacillus paralicheniformis strain AP-01
title_full Safety evaluation of the food enzyme subtilisin from the non-genetically modified Bacillus paralicheniformis strain AP-01
title_fullStr Safety evaluation of the food enzyme subtilisin from the non-genetically modified Bacillus paralicheniformis strain AP-01
title_full_unstemmed Safety evaluation of the food enzyme subtilisin from the non-genetically modified Bacillus paralicheniformis strain AP-01
title_sort Safety evaluation of the food enzyme subtilisin from the non-genetically modified Bacillus paralicheniformis strain AP-01
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 Bacillus paralicheniformis
EC 3.4.21.62
Serine endopeptidase
Subtilisin
topic Bacillus paralicheniformis
EC 3.4.21.62
Serine endopeptidase
Subtilisin
description [EN] The food enzyme subtilisin (EC 3.4.21.62) is produced with the non-genetically modified Bacillus paralicheniformis strain AP-01 by Nagase (Europa) GmbH. It was considered free from viable cells of the production organism. The food enzyme is intended to be used in five food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in one process, dietary exposure was calculated only for the remaining four food manufacturing processes. It was estimated to be up to 0.875 mg TOS/kg body weight per day in European populations. The production strain of the food enzyme has the capacity to produce bacitracin and thus failed to meet the requirements of the Qualified Presumption of Safety approach. Bacitracin was detected in the industrial fermentation medium but not in the food enzyme itself. However, the limit of detection of the analytical method used for bacitracin was not sufficient to exclude the possible presence of bacitracin at a level representing a risk for the development of antimicrobial resistant bacteria. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and twenty-eight matches with respiratory allergens, one match with a contact allergen and two matches with food allergens (melon and pomegranate) were found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to melon or pomegranate, cannot be excluded, but would not exceed the risk of consuming melon or pomegranate. Based on the data provided, the Panel could not exclude the presence of bacitracin, a medically important antimicrobial, and consequently the safety of this food enzyme could not be established.
publishDate 2024
dc.date.none.fl_str_mv 2024
2024-07-31
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/10251/224406
url https://riunet.upv.es/handle/10251/224406
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
_version_ 1869404580711759872
score 15.812429

Similares en LA Referencia