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Safety evaluation of the food enzyme glucan 1,4-alpha-glucosidase from the genetically modified Aspergillus niger strain NZYM-BE

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Safety evaluation of the food enzyme glucan 1,4-alpha-glucosidase from the genetically modified Aspergillus niger strain NZYM-BE

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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 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.contributor.author Vernis, Laurence es_ES
dc.date.accessioned 2023-06-02T18:00:49Z
dc.date.available 2023-06-02T18:00:49Z
dc.date.issued 2022-06 es_ES
dc.identifier.uri http://hdl.handle.net/10251/193849
dc.description.abstract [EN] The food enzyme glucan 1,4-alpha-glucosidase (4-alpha-D-glucan glucohydrolase EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM-BE by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme was free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in six food manufacturing processes, namely starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production, brewing processes, baking processes, cereal-based processes, and fruit and vegetable processing for juice production. Since residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied to produce glucose syrups, dietary exposure was not calculated for these two food processes. For the remaining four processes, dietary exposure to the food enzyme-TOS was estimated to be up to 7.7 mg 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 3,795 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 490. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched for and one match found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production) the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur 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. 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 Glucan 1,4-alpha-glucosidase es_ES
dc.subject 4-alpha-D-glucan glucohydrolase es_ES
dc.subject EC 3.2.1.3 es_ES
dc.subject Glucomylase 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 glucan 1,4-alpha-glucosidase from the genetically modified Aspergillus niger strain NZYM-BE es_ES
dc.type Artículo es_ES
dc.identifier.doi 10.2903/j.efsa.2022.7374 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 Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.; Grob, K.... (2022). Safety evaluation of the food enzyme glucan 1,4-alpha-glucosidase from the genetically modified Aspergillus niger strain NZYM-BE. EFSA Journal. 20(6):1-17. https://doi.org/10.2903/j.efsa.2022.7374 es_ES
dc.description.accrualMethod S es_ES
dc.relation.publisherversion https://doi.org/10.2903/j.efsa.2022.7374 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 6 es_ES
dc.identifier.eissn 1831-4732 es_ES
dc.identifier.pmid 35784821 es_ES
dc.identifier.pmcid PMC9244779 es_ES
dc.relation.pasarela S\487621 es_ES


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