Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29546

[EN] The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Aspergillus niger strain DSM 29546 by Chr. Hansen. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to...

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Autores: Silano, Vittorio, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lambré, Claude, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger-Lise, Tlustos, Christina, van Loveren, Henk, 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:10251/194186
Acceso en línea:https://riunet.upv.es/handle/10251/194186
Access Level:acceso abierto
Palabra clave:Food enzyme
Chymosin
Rennin
EC 34234
Aspergillus niger
Genetically modified microorganism
TECNOLOGIA DE ALIMENTOS
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spelling Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29546Silano, VittorioBolognesi, ClaudiaCocconcelli, Pier SandroCrebelli, RiccardoGott, David MichaelGrob, KonradLambré, ClaudeLampi, EvgeniaMengelers, MarcelMortensen, AlicjaRivière, GillesSteffensen, Inger-LiseTlustos, Christinavan Loveren, HenkBarat Baviera, José Manuel|||0000-0001-8487-7114Food enzymeChymosinRenninEC 34234Aspergillus nigerGenetically modified microorganismTECNOLOGIA DE ALIMENTOS[EN] The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Aspergillus niger strain DSM 29546 by Chr. Hansen. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in milk processing for cheese production and for the production of fermented milk products. Dietary exposure was estimated to be up to 0.52 mg total organic solids (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 410 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 790. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure, although unlikely, cannot be excluded, particularly for individuals sensitised to cedar pollen allergens. 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 Riunet20222022-08-01journal articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://riunet.upv.es/handle/10251/194186reponame: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:10251/1941862026-06-13T07:49:27Z
dc.title.none.fl_str_mv Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29546
title Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29546
spellingShingle Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29546
Silano, Vittorio
Food enzyme
Chymosin
Rennin
EC 34234
Aspergillus niger
Genetically modified microorganism
TECNOLOGIA DE ALIMENTOS
title_short Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29546
title_full Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29546
title_fullStr Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29546
title_full_unstemmed Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29546
title_sort Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29546
dc.creator.none.fl_str_mv Silano, Vittorio
Bolognesi, Claudia
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lambré, Claude
Lampi, Evgenia
Mengelers, Marcel
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger-Lise
Tlustos, Christina
van Loveren, Henk
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
Lambré, Claude
Lampi, Evgenia
Mengelers, Marcel
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger-Lise
Tlustos, Christina
van Loveren, Henk
Barat Baviera, José Manuel|||0000-0001-8487-7114
author_role author
author2 Bolognesi, Claudia
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lambré, Claude
Lampi, Evgenia
Mengelers, Marcel
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger-Lise
Tlustos, Christina
van Loveren, Henk
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
Chymosin
Rennin
EC 34234
Aspergillus niger
Genetically modified microorganism
TECNOLOGIA DE ALIMENTOS
topic Food enzyme
Chymosin
Rennin
EC 34234
Aspergillus niger
Genetically modified microorganism
TECNOLOGIA DE ALIMENTOS
description [EN] The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Aspergillus niger strain DSM 29546 by Chr. Hansen. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in milk processing for cheese production and for the production of fermented milk products. Dietary exposure was estimated to be up to 0.52 mg total organic solids (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 410 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 790. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure, although unlikely, cannot be excluded, particularly for individuals sensitised to cedar pollen allergens. 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
2022-08-01
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/10251/194186
url https://riunet.upv.es/handle/10251/194186
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_ 1869409303362797568
score 15,300719

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