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Safety evaluation of the food enzyme beta-galactosidase from the non-genetically modified Neobacillus sp. strain AE-LT

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Safety evaluation of the food enzyme beta-galactosidase from the non-genetically modified Neobacillus sp. strain AE-LT

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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 2023-06-09T18:01:51Z
dc.date.available 2023-06-09T18:01:51Z
dc.date.issued 2022-10 es_ES
dc.identifier.uri http://hdl.handle.net/10251/194038
dc.description.abstract [EN] The food enzyme beta-galactosidase (EC 3.2.1.23) is produced with the non-genetically modified Neobacillus sp. strain AE-LT by Amano Enzyme Inc. The strain is not cytotoxic and does not harbour any known virulence factor or antimicrobial resistance gene. The presence of viable cells of the production strain in the food enzyme could not be excluded, but the likelihood of this being a hazard is considered low. The food enzyme is intended to be used for lactose hydrolysis in milk processing and the manufacture of galacto-oligosaccharides (GOS). The dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 2.971 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 1,223 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 412. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is 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 Helen Regina for the support provided to this scientific output. 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 Beta-galactosidase es_ES
dc.subject EC 3.2.1.23 es_ES
dc.subject Beta-D-galactoside galatohydrolase es_ES
dc.subject Bacillus circulans es_ES
dc.subject Neobacillus sp es_ES
dc.subject Non-genetically modified organism es_ES
dc.subject.classification TECNOLOGIA DE ALIMENTOS es_ES
dc.title Safety evaluation of the food enzyme beta-galactosidase from the non-genetically modified Neobacillus sp. strain AE-LT es_ES
dc.type Artículo es_ES
dc.identifier.doi 10.2903/j.efsa.2022.7573 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 beta-galactosidase from the non-genetically modified Neobacillus sp. strain AE-LT. EFSA Journal. 20(10):1-15. https://doi.org/10.2903/j.efsa.2022.7573 es_ES
dc.description.accrualMethod S es_ES
dc.relation.publisherversion https://doi.org/10.2903/j.efsa.2022.7573 es_ES
dc.description.upvformatpinicio 1 es_ES
dc.description.upvformatpfin 15 es_ES
dc.type.version info:eu-repo/semantics/publishedVersion es_ES
dc.description.volume 20 es_ES
dc.description.issue 10 es_ES
dc.identifier.eissn 1831-4732 es_ES
dc.identifier.pmid 36254194 es_ES
dc.identifier.pmcid PMC9554760 es_ES
dc.relation.pasarela S\486684 es_ES


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