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

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

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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 2023-06-01T18:01:27Z
dc.date.available 2023-06-01T18:01:27Z
dc.date.issued 2022-03 es_ES
dc.identifier.uri http://hdl.handle.net/10251/193809
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-BR 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 (TOS) are removed by the purification steps applied during the production of glucose syrups and by distillation, dietary exposure estimation was considered not necessary. 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 1,135 mg TOS/kg body weight (bw) per day, the highest dose tested. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched for and two matches were 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.description.sponsorship The Panel wishes to thank the following for the support provided to this scientific output: Erik Boinowitz, Daniele Cavanna, Ana Gomes, Simone Lunardi, Sandra Rainieri, and Helen Regina. 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-glucosidase4-alpha-D-glucan glucohydrolase es_ES
dc.subject EC 3.2.1.3 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-BR es_ES
dc.type Artículo es_ES
dc.identifier.doi 10.2903/j.efsa.2022.7191 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-BR. EFSA Journal. 20(3):1-13. https://doi.org/10.2903/j.efsa.2022.7191 es_ES
dc.description.accrualMethod S es_ES
dc.relation.publisherversion https://doi.org/10.2903/j.efsa.2022.7191 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 20 es_ES
dc.description.issue 3 es_ES
dc.identifier.eissn 1831-4732 es_ES
dc.identifier.pmid 35281642 es_ES
dc.identifier.pmcid PMC8905423 es_ES
dc.relation.pasarela S\486706 es_ES


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