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Safety and efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase (produced by Aspergillus oryzae DSM 33700) (RONOZYME® WX (CT/L)) for all poultry species and all Suidae (DSM nutritional products ltd)

2023-10-19Journal article Open access
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dc.contributor.authorEFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
dc.contributor.authorBampidis, Vasileios
dc.contributor.authorAzimonti, Giovanna
dc.contributor.authorBastos, Maria de Lourdes
dc.contributor.authorChristensen, Henrik
dc.contributor.authorDurjava, Mojca
dc.contributor.authorDusemund, Birgit
dc.contributor.authorKouba, Maryline
dc.contributor.authorLópez‐Alonso, Marta
dc.contributor.authorLópez Puente, Secundino
dc.contributor.authorMarcon, Francesca
dc.contributor.authorMayo, Baltasar
dc.contributor.authorPechová, Alena
dc.contributor.authorPetkova, Mariana
dc.contributor.authorRamos, Fernando
dc.contributor.authorVilla, Roberto Edoardo
dc.contributor.authorWoutersen, Ruud
dc.contributor.authorBrantom, Paul
dc.contributor.authorLouro, Henriqueta
dc.contributor.authorSvensson, Kettil
dc.contributor.authorNovo, Natalia Alija
dc.contributor.authorBrozzi, Rosella
dc.contributor.authorInnocenti, Matteo Lorenzo
dc.contributor.authorCasanova, Jordi Ortuño
dc.contributor.authorPizzo, Fabiola
dc.contributor.authorPettenati, Elisa
dc.date.accessioned2024-01-03T15:07:46Z
dc.date.available2024-01-03T15:07:46Z
dc.date.issued2023-10-19
dc.descriptionFree PMC article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10585426/pt_PT
dc.description.abstractThe additive RONOZYME® WX (CT/L) contains endo-1,4-beta-xylanase produced with a genetically modified strain of the filamentous fungus Aspergillus oryzae; the additive is currently authorised for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens. The applicant has requested to change the production strain, substituting strain A. oryzae DSM 26372 with A. oryzae DSM 33700, and to extend the use of the additive to all poultry species and all Suidae. RONOZYME® WX (CT/L), manufactured with the production strain A. oryzae DSM 33700, did not give rise to safety concerns with regard to the genetic modification of the production strain. No viable cells of the production strain nor its DNA were detected in an intermediate product representative of both final formulations of the additive. RONOZYME® WX (CT/L) was considered safe for all poultry species and all Suidae at the recommended inclusion levels. The use of RONOZYME® WX CT and L manufactured with the production strain A. oryzae DSM 33700 raised no concerns for consumers. RONOZYME® WX L is not an eye irritant; however, no conclusions could be drawn on the potential of RONOZYME® WX CT to be an eye irritant. Both formulations are not irritant to the skin, but due to the lack of data, the FEEDAP Panel was not able to conclude on the potential of both formulations of the additive to be skin sensitisers. Due to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. The additive manufactured by A. oryzae DSM 33700 raises no safety concerns for the environment. The additive has the potential to be efficacious in all poultry species and all Suidae at 100 and 200 FXU/kg complete feed, respectively.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationEFSA J . 2023 Oct 19;21(10):e08339. doi: 10.2903/j.efsa.2023.8339. eCollection 2023 Oct.pt_PT
dc.identifier.doi10.2903/j.efsa.2023.8339pt_PT
dc.identifier.issn1831-4732
dc.identifier.urihttp://hdl.handle.net/10400.18/8825
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherWiley/ European Food Safety Authoritypt_PT
dc.relation.publisherversionhttps://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2023.8339pt_PT
dc.rights.urihttp://creativecommons.org/licenses/by-nd/4.0/pt_PT
dc.subjectEnvironmental Genotoxicitypt_PT
dc.subjectRONOZYME® WX CT/Lpt_PT
dc.subjectDigestibility Enhancerspt_PT
dc.subjectEfficacypt_PT
dc.subjectEndo‐1,4‐beta‐xylanasept_PT
dc.subjectSafetypt_PT
dc.subjectZootechnical Additivespt_PT
dc.subjectGenotoxicidade Ambientalpt_PT
dc.titleSafety and efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase (produced by Aspergillus oryzae DSM 33700) (RONOZYME® WX (CT/L)) for all poultry species and all Suidae (DSM nutritional products ltd)pt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue10pt_PT
oaire.citation.startPagee08339pt_PT
oaire.citation.titleEFSA Journalpt_PT
oaire.citation.volume21pt_PT
person.familyNameLouro
person.givenNameHenriqueta
person.identifier157627
person.identifier.ciencia-id721D-2BB1-7DB1
person.identifier.orcid0000-0001-9744-7332
person.identifier.scopus-author-id6507971479
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublication2361a951-8b9a-4b90-92d6-f6384003a242
relation.isAuthorOfPublication.latestForDiscovery2361a951-8b9a-4b90-92d6-f6384003a242

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