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

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

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dc.contributor.author Silano, Vittorio es_ES
dc.contributor.author Barat Baviera, José Manuel es_ES
dc.contributor.author Bolognesi, Claudia es_ES
dc.contributor.author Cocconcelli, Pier Sandro es_ES
dc.contributor.author Crebelli, Riccardo es_ES
dc.contributor.author Gott, David Michael es_ES
dc.contributor.author Grob, Konrad es_ES
dc.contributor.author Lambré, Claude es_ES
dc.contributor.author Lampi, Evgenia es_ES
dc.contributor.author Mengelers, Marcel es_ES
dc.contributor.author Mortensen, Alicja es_ES
dc.contributor.author Rivière, Gilles es_ES
dc.contributor.author Steffensen, Inger-Lise es_ES
dc.contributor.author Tlustos, Christina es_ES
dc.contributor.author van Loveren, Henk es_ES
dc.date.accessioned 2023-06-13T18:03:22Z
dc.date.available 2023-06-13T18:03:22Z
dc.date.issued 2022-08 es_ES
dc.identifier.uri http://hdl.handle.net/10251/194186
dc.description.abstract [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. es_ES
dc.language Inglés es_ES
dc.publisher Willey es_ES
dc.relation.ispartof EFSA Journal es_ES
dc.rights Reconocimiento - Sin obra derivada (by-nd) es_ES
dc.subject Food enzyme es_ES
dc.subject Chymosin es_ES
dc.subject Rennin es_ES
dc.subject EC 34234 es_ES
dc.subject Aspergillus niger es_ES
dc.subject Genetically modified microorganism es_ES
dc.subject.classification TECNOLOGIA DE ALIMENTOS es_ES
dc.title Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29546 es_ES
dc.type Artículo es_ES
dc.identifier.doi 10.2903/j.efsa.2022.7465 es_ES
dc.rights.accessRights Abierto es_ES
dc.contributor.affiliation Universitat Politècnica de València. Escuela Técnica Superior de Ingeniería Agronómica y del Medio Natural - Escola Tècnica Superior d'Enginyeria Agronòmica i del Medi Natural es_ES
dc.description.bibliographicCitation Silano, V.; Barat Baviera, JM.; Bolognesi, C.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.; Grob, K.... (2022). Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29546. EFSA Journal. 20(8):1-17. https://doi.org/10.2903/j.efsa.2022.7465 es_ES
dc.description.accrualMethod S es_ES
dc.relation.publisherversion https://doi.org/10.2903/j.efsa.2022.7465 es_ES
dc.description.upvformatpinicio 1 es_ES
dc.description.upvformatpfin 17 es_ES
dc.type.version info:eu-repo/semantics/publishedVersion es_ES
dc.description.volume 20 es_ES
dc.description.issue 8 es_ES
dc.identifier.eissn 1831-4732 es_ES
dc.identifier.pmid 35949933 es_ES
dc.identifier.pmcid PMC9350884 es_ES
dc.relation.pasarela S\487523 es_ES


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