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Safety evaluation of a food enzyme with glucan 1,4-alpha-glucosidase and alpha-amylase activities from the genetically modified Aspergillus niger strain NZYM-BX

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Safety evaluation of a food enzyme with glucan 1,4-alpha-glucosidase and alpha-amylase activities from the genetically modified Aspergillus niger strain NZYM-BX

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dc.contributor.author Lambré, Claude 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 Lampi, Evgenia es_ES
dc.contributor.author Mengelers, Marcel es_ES
dc.contributor.author Mortensen, Alicja es_ES
dc.contributor.author Riviere, 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.contributor.author Vernis, Laurence es_ES
dc.date.accessioned 2022-07-26T18:07:37Z
dc.date.available 2022-07-26T18:07:37Z
dc.date.issued 2021-05 es_ES
dc.identifier.uri http://hdl.handle.net/10251/184810
dc.description.abstract [EN] The food enzyme with glucan 1,4-alpha-glucosidase (EC 3.2.1.3) and alpha-amylase (EC 3.2.1.1) activities is produced with the genetically modified strain of Aspergillus niger NZYM-BX by Novozymes A/S. 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. The food enzyme is intended to be used in starch processing for the production of glucose syrups and distilled alcohol. Since residual amounts of total organic solids are removed by distillation and by the purification steps applied during the production of glucose syrups, dietary exposure was not calculated. Genotoxicity tests did not raise a safety concern. The repeated dose 90-day oral toxicity study in rats made with a substitute enzyme was not considered suitable. However, since no exposure was expected from the intended uses, this study was not considered necessary. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and two matches were 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 is considered to be 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. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority 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 1,4-alpha-glucosidase es_ES
dc.subject Alpha-amylase es_ES
dc.subject EC 3.2.1.3 es_ES
dc.subject EC 3.2.1.1 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 a food enzyme with glucan 1,4-alpha-glucosidase and alpha-amylase activities from the genetically modified Aspergillus niger strain NZYM-BX es_ES
dc.type Artículo es_ES
dc.identifier.doi 10.2903/j.efsa.2021.6563 es_ES
dc.rights.accessRights Abierto es_ES
dc.contributor.affiliation Universitat Politècnica de València. Departamento de Tecnología de Alimentos - Departament de Tecnologia d'Aliments es_ES
dc.description.bibliographicCitation Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.; Grob, K.... (2021). Safety evaluation of a food enzyme with glucan 1,4-alpha-glucosidase and alpha-amylase activities from the genetically modified Aspergillus niger strain NZYM-BX. EFSA Journal. 19(5):1-13. https://doi.org/10.2903/j.efsa.2021.6563 es_ES
dc.description.accrualMethod S es_ES
dc.relation.publisherversion https://doi.org/10.2903/j.efsa.2021.6563 es_ES
dc.description.upvformatpinicio 1 es_ES
dc.description.upvformatpfin 13 es_ES
dc.type.version info:eu-repo/semantics/publishedVersion es_ES
dc.description.volume 19 es_ES
dc.description.issue 5 es_ES
dc.identifier.eissn 1831-4732 es_ES
dc.identifier.pmid 34012488 es_ES
dc.identifier.pmcid PMC8114200 es_ES
dc.relation.pasarela S\458799 es_ES


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