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Safety and efficacy of a feed additive consisting of endo‐1,3(4)‐beta‐glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L)) for chickens for fattening and weaned piglets (DSM Nutritional Products AG)

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of endo‐1,3(4)‐beta‐glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L))...

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Autores principales: Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Dusemund, Birgit, Fašmon Durjava, Mojca, Kouba, Maryline, López‐Alonso, Marta, Puente, Secundino López, Marcon, Francesca, Mayo, Baltasar, Pechová, Alena, Petkova, Mariana, Ramos, Fernando, Sanz, Yolanda, Villa, Roberto Edoardo, Woutersen, Ruud, Galobart, Jaume, Pettenati, Elisa, Ortuño, Jordi, Anguita, Montserrat
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9832830/
https://www.ncbi.nlm.nih.gov/pubmed/36643908
http://dx.doi.org/10.2903/j.efsa.2023.7703
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author Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Fašmon Durjava, Mojca
Kouba, Maryline
López‐Alonso, Marta
Puente, Secundino López
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Galobart, Jaume
Pettenati, Elisa
Ortuño, Jordi
Anguita, Montserrat
author_facet Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Fašmon Durjava, Mojca
Kouba, Maryline
López‐Alonso, Marta
Puente, Secundino López
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Galobart, Jaume
Pettenati, Elisa
Ortuño, Jordi
Anguita, Montserrat
collection PubMed
description Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of endo‐1,3(4)‐beta‐glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L)) as a zootechnical feed additive for chickens for fattening and weaned piglets. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats and the tolerance trials provided, the additive was considered safe for chickens for fattening and weaned piglets at the proposed conditions of use. The Panel also concluded that the use of the product as a feed additive does not rise concerns for consumers and the environment. Owing to the lack of data obtained with the final formulations, the Panel could not conclude on the potential of the additive to be irritant to skin and eyes or on its potential as a dermal sensitiser. Due to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. The Panel concluded that the additive is efficacious as a zootechnical additive in chickens for fattening and weaned piglets at the minimum recommended level of 10 FBG/kg feed.
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spelling pubmed-98328302023-01-12 Safety and efficacy of a feed additive consisting of endo‐1,3(4)‐beta‐glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L)) for chickens for fattening and weaned piglets (DSM Nutritional Products AG) Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Fašmon Durjava, Mojca Kouba, Maryline López‐Alonso, Marta Puente, Secundino López Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Galobart, Jaume Pettenati, Elisa Ortuño, Jordi Anguita, Montserrat EFSA J Scientific Opinion Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of endo‐1,3(4)‐beta‐glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L)) as a zootechnical feed additive for chickens for fattening and weaned piglets. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats and the tolerance trials provided, the additive was considered safe for chickens for fattening and weaned piglets at the proposed conditions of use. The Panel also concluded that the use of the product as a feed additive does not rise concerns for consumers and the environment. Owing to the lack of data obtained with the final formulations, the Panel could not conclude on the potential of the additive to be irritant to skin and eyes or on its potential as a dermal sensitiser. Due to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. The Panel concluded that the additive is efficacious as a zootechnical additive in chickens for fattening and weaned piglets at the minimum recommended level of 10 FBG/kg feed. John Wiley and Sons Inc. 2023-01-11 /pmc/articles/PMC9832830/ /pubmed/36643908 http://dx.doi.org/10.2903/j.efsa.2023.7703 Text en © 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://creativecommons.org/licenses/by-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
spellingShingle Scientific Opinion
Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Fašmon Durjava, Mojca
Kouba, Maryline
López‐Alonso, Marta
Puente, Secundino López
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Galobart, Jaume
Pettenati, Elisa
Ortuño, Jordi
Anguita, Montserrat
Safety and efficacy of a feed additive consisting of endo‐1,3(4)‐beta‐glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L)) for chickens for fattening and weaned piglets (DSM Nutritional Products AG)
title Safety and efficacy of a feed additive consisting of endo‐1,3(4)‐beta‐glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L)) for chickens for fattening and weaned piglets (DSM Nutritional Products AG)
title_full Safety and efficacy of a feed additive consisting of endo‐1,3(4)‐beta‐glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L)) for chickens for fattening and weaned piglets (DSM Nutritional Products AG)
title_fullStr Safety and efficacy of a feed additive consisting of endo‐1,3(4)‐beta‐glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L)) for chickens for fattening and weaned piglets (DSM Nutritional Products AG)
title_full_unstemmed Safety and efficacy of a feed additive consisting of endo‐1,3(4)‐beta‐glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L)) for chickens for fattening and weaned piglets (DSM Nutritional Products AG)
title_short Safety and efficacy of a feed additive consisting of endo‐1,3(4)‐beta‐glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L)) for chickens for fattening and weaned piglets (DSM Nutritional Products AG)
title_sort safety and efficacy of a feed additive consisting of endo‐1,3(4)‐beta‐glucanase produced by aspergillus fijiensis cbs 589.94 (ronozyme® vp (ct/l)) for chickens for fattening and weaned piglets (dsm nutritional products ag)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9832830/
https://www.ncbi.nlm.nih.gov/pubmed/36643908
http://dx.doi.org/10.2903/j.efsa.2023.7703
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