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Safety evaluation of the food enzyme catalase from the genetically modified Aspergillus niger strain DP-Azw58

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Safety evaluation of the food enzyme catalase from the genetically modified Aspergillus niger strain DP-Azw58

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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 2022-09-09T18:04:49Z
dc.date.available 2022-09-09T18:04:49Z
dc.date.issued 2021-08-13 es_ES
dc.identifier.uri http://hdl.handle.net/10251/185769
dc.description.abstract [EN] The food enzyme catalase (hydrogen-peroxide:hydrogen-peroxide oxidoreductase; EC 1.11.1.6) is produced with the genetically modified Aspergillus niger strain DP-Azw58 by Danisco US, Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in egg processing. Based on the maximum use levels, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 1 mu g TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 1,288 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 1.3 x 10(6). A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was 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 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. (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 Catalase es_ES
dc.subject Hydrogen-peroxide:hydrogen-peroxide oxidoreductase es_ES
dc.subject EC 1.11.1.6 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 catalase from the genetically modified Aspergillus niger strain DP-Azw58 es_ES
dc.type Artículo es_ES
dc.identifier.doi 10.2903/j.efsa.2021.6787 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 the food enzyme catalase from the genetically modified Aspergillus niger strain DP-Azw58. EFSA Journal. 19(8):1-15. https://doi.org/10.2903/j.efsa.2021.6787 es_ES
dc.description.accrualMethod S es_ES
dc.relation.publisherversion https://doi.org/10.2903/j.efsa.2021.6787 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 19 es_ES
dc.description.issue 8 es_ES
dc.identifier.eissn 1831-4732 es_ES
dc.identifier.pmid 34429779 es_ES
dc.identifier.pmcid PMC8362335 es_ES
dc.relation.pasarela S\457934 es_ES


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