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Safety evaluation of the food enzyme glucan 1,4-alpha-maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM-SD

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Safety evaluation of the food enzyme glucan 1,4-alpha-maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM-SD

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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 Laurence Vernis es_ES
dc.date.accessioned 2023-06-06T18:01:53Z
dc.date.available 2023-06-06T18:01:53Z
dc.date.issued 2022-06 es_ES
dc.identifier.uri http://hdl.handle.net/10251/193918
dc.description.abstract [EN] The food enzyme glucan 1,4-alpha-maltohydrolase (4-alpha-d-glucan alpha-maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM-SD by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking processes and brewing processes and starch processing for glucose syrup production and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for baking and brewing processes. Dietary exposure was estimated to be up to 0.57 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. Similarity of the amino acid sequence 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 upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4-alpha-maltohydrolase produced with the genetically modified B. licheniformis strain NZYM-SD 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: Simone Lunardi. 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-maltohydrolase es_ES
dc.subject 4-alpha-D-glucan alpha-maltohydrolase es_ES
dc.subject Maltogenic amylase es_ES
dc.subject 3.2.1.133 es_ES
dc.subject Bacillus licheniformis 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-maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM-SD es_ES
dc.type Artículo es_ES
dc.identifier.doi 10.2903/j.efsa.2022.7368 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-maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM-SD. EFSA Journal. 20(6):1-15. https://doi.org/10.2903/j.efsa.2022.7368 es_ES
dc.description.accrualMethod S es_ES
dc.relation.publisherversion https://doi.org/10.2903/j.efsa.2022.7368 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 6 es_ES
dc.identifier.eissn 1831-4732 es_ES
dc.identifier.pmid 35757150 es_ES
dc.identifier.pmcid PMC9200369 es_ES
dc.relation.pasarela S\486688 es_ES


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