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)

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP); Bampidis, Vasileios; Azimonti, Giovanna; Bastos, Maria de Lourdes; Christensen, Henrik; Durjava, Mojca; Dusemund, Birgit; Kouba, Maryline; López‐Alonso, Marta; López Puente, Secundino; Marcon, Francesca; Mayo, Baltasar; Pechová, Alena; Petkova, Mariana; Ramos, Fernando; Villa, Roberto Edoardo; Woutersen, Ruud; Brantom, Paul; Louro, Henriqueta; Svensson, Kettil; Novo, Natalia Alija; Brozzi, Rosella; Innocenti, Matteo Lorenzo; Casanova, Jordi Ortuño; Pizzo, Fabiola; Pettenati, Elisa

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)

Detalhes bibliográficos
Autor(a) principal:	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Data de Publicação:	2023
Outros Autores:	Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Durjava, Mojca, Dusemund, Birgit, Kouba, Maryline, López‐Alonso, Marta, López Puente, Secundino, Marcon, Francesca, Mayo, Baltasar, Pechová, Alena, Petkova, Mariana, Ramos, Fernando, Villa, Roberto Edoardo, Woutersen, Ruud, Brantom, Paul, Louro, Henriqueta, Svensson, Kettil, Novo, Natalia Alija, Brozzi, Rosella, Innocenti, Matteo Lorenzo, Casanova, Jordi Ortuño, Pizzo, Fabiola, Pettenati, Elisa
Tipo de documento:	Artigo
Idioma:	eng
Título da fonte:	Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo:	http://hdl.handle.net/10400.18/8825
Resumo:	Free PMC article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10585426/

Metadados do item

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network_acronym_str	RCAP
network_name_str	Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository_id_str	7160
spelling	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)Environmental GenotoxicityRONOZYME® WX CT/LDigestibility EnhancersEfficacyEndo‐1,4‐beta‐xylanaseSafetyZootechnical AdditivesGenotoxicidade AmbientalFree PMC article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10585426/The 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.Wiley/ European Food Safety AuthorityRepositório Científico do Instituto Nacional de SaúdeEFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Bampidis, VasileiosAzimonti, GiovannaBastos, Maria de LourdesChristensen, HenrikDurjava, MojcaDusemund, BirgitKouba, MarylineLópez‐Alonso, MartaLópez Puente, SecundinoMarcon, FrancescaMayo, BaltasarPechová, AlenaPetkova, MarianaRamos, FernandoVilla, Roberto EdoardoWoutersen, RuudBrantom, PaulLouro, HenriquetaSvensson, KettilNovo, Natalia AlijaBrozzi, RosellaInnocenti, Matteo LorenzoCasanova, Jordi OrtuñoPizzo, FabiolaPettenati, Elisa2024-01-03T15:07:46Z2023-10-192023-10-19T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10400.18/8825engEFSA J . 2023 Oct 19;21(10):e08339. doi: 10.2903/j.efsa.2023.8339. eCollection 2023 Oct.1831-473210.2903/j.efsa.2023.8339info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-01-06T01:33:40Zoai:repositorio.insa.pt:10400.18/8825Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T01:30:30.069985Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv	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)
title	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)
spellingShingle	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) EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Environmental Genotoxicity RONOZYME® WX CT/L Digestibility Enhancers Efficacy Endo‐1,4‐beta‐xylanase Safety Zootechnical Additives Genotoxicidade Ambiental
title_short	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)
title_full	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)
title_fullStr	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)
title_full_unstemmed	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)
title_sort	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)
author	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
author_facet	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Durjava, Mojca Dusemund, Birgit Kouba, Maryline López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Villa, Roberto Edoardo Woutersen, Ruud Brantom, Paul Louro, Henriqueta Svensson, Kettil Novo, Natalia Alija Brozzi, Rosella Innocenti, Matteo Lorenzo Casanova, Jordi Ortuño Pizzo, Fabiola Pettenati, Elisa
author_role	author
author2	Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Durjava, Mojca Dusemund, Birgit Kouba, Maryline López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Villa, Roberto Edoardo Woutersen, Ruud Brantom, Paul Louro, Henriqueta Svensson, Kettil Novo, Natalia Alija Brozzi, Rosella Innocenti, Matteo Lorenzo Casanova, Jordi Ortuño Pizzo, Fabiola Pettenati, Elisa
author2_role	author author author author author author author author author author author author author author author author author author author author author author author author author
dc.contributor.none.fl_str_mv	Repositório Científico do Instituto Nacional de Saúde
dc.contributor.author.fl_str_mv	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Durjava, Mojca Dusemund, Birgit Kouba, Maryline López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Villa, Roberto Edoardo Woutersen, Ruud Brantom, Paul Louro, Henriqueta Svensson, Kettil Novo, Natalia Alija Brozzi, Rosella Innocenti, Matteo Lorenzo Casanova, Jordi Ortuño Pizzo, Fabiola Pettenati, Elisa
dc.subject.por.fl_str_mv	Environmental Genotoxicity RONOZYME® WX CT/L Digestibility Enhancers Efficacy Endo‐1,4‐beta‐xylanase Safety Zootechnical Additives Genotoxicidade Ambiental
topic	Environmental Genotoxicity RONOZYME® WX CT/L Digestibility Enhancers Efficacy Endo‐1,4‐beta‐xylanase Safety Zootechnical Additives Genotoxicidade Ambiental
description	Free PMC article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10585426/
publishDate	2023
dc.date.none.fl_str_mv	2023-10-19 2023-10-19T00:00:00Z 2024-01-03T15:07:46Z
dc.type.status.fl_str_mv	info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv	info:eu-repo/semantics/article
format	article
status_str	publishedVersion
dc.identifier.uri.fl_str_mv	http://hdl.handle.net/10400.18/8825
url	http://hdl.handle.net/10400.18/8825
dc.language.iso.fl_str_mv	eng
language	eng
dc.relation.none.fl_str_mv	EFSA J . 2023 Oct 19;21(10):e08339. doi: 10.2903/j.efsa.2023.8339. eCollection 2023 Oct. 1831-4732 10.2903/j.efsa.2023.8339
dc.rights.driver.fl_str_mv	info:eu-repo/semantics/openAccess
eu_rights_str_mv	openAccess
dc.format.none.fl_str_mv	application/pdf
dc.publisher.none.fl_str_mv	Wiley/ European Food Safety Authority
publisher.none.fl_str_mv	Wiley/ European Food Safety Authority
dc.source.none.fl_str_mv	reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP
instname_str	Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str	RCAAP
institution	RCAAP
reponame_str	Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection	Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv	Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
repository.mail.fl_str_mv
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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)

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