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Safety and efficacy of Robenz(®) 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Following a request from European Commission, the 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 Robenz(®) 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening...

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Autores principales: Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Dusemund, Birgit, Kouba, Maryline, Kos Durjava, Mojca, López‐Alonso, Marta, López Puente, Secundino, Marcon, Francesca, Mayo, Baltasar, Pechová, Alena, Petkova, Mariana, Ramos, Fernando, Sanz, Yolanda, Villa, Roberto Edoardo, Woutersen, Ruud, Aquilina, Gabriele, Bories, Georges, Brantom, Paul, Cocconcelli, Pier Sandro, Halle, Ingrid, Kolar, Boris, Wester, Pieter, van Beelen, Patrick, Holczknecht, Orsolya, Vettori, Maria Vittoria, Gropp, Jürgen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009205/
https://www.ncbi.nlm.nih.gov/pubmed/32626244
http://dx.doi.org/10.2903/j.efsa.2019.5613
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author Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Kouba, Maryline
Kos Durjava, Mojca
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Aquilina, Gabriele
Bories, Georges
Brantom, Paul
Cocconcelli, Pier Sandro
Halle, Ingrid
Kolar, Boris
Wester, Pieter
van Beelen, Patrick
Holczknecht, Orsolya
Vettori, Maria Vittoria
Gropp, Jürgen
author_facet Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Kouba, Maryline
Kos Durjava, Mojca
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Aquilina, Gabriele
Bories, Georges
Brantom, Paul
Cocconcelli, Pier Sandro
Halle, Ingrid
Kolar, Boris
Wester, Pieter
van Beelen, Patrick
Holczknecht, Orsolya
Vettori, Maria Vittoria
Gropp, Jürgen
collection PubMed
description Following a request from European Commission, the 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 Robenz(®) 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz(®) 66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a margin of safety of approximately 2.5. This conclusion is extrapolated to turkeys for fattening. Robenidine HCl is active against Gram‐positive but not against Gram‐negative bacteria. It is not expected that the use of robenidine HCl as a feed additive would induce resistance or cross‐resistance to antimicrobials used in human and animal therapy. The use of robenidine HCl from Robenz(®) 66G at the highest proposed level of 36 mg/kg complete feed in chickens and turkeys for fattening is considered safe for the consumer. The existing maximum residues limits for both avian species are confirmed. Robenidine HCl is not a skin or eye irritant and not a skin sensitiser. The risk via inhalation is considered negligible. The use of robenidine HCl from Robenz(®) in feed for chickens for fattening and turkeys for fattening up to 36 mg/kg complete feed does not pose a risk to either the terrestrial or the aquatic compartment. A risk for bioaccumulation cannot be excluded. The risk for secondary poisoning is not likely to occur. The FEEDAP Panel concludes that 36 mg robenidine HCl/kg complete feed from Robenz(®) 66G has the potential to effectively control coccidiosis of chickens for fattening under field conditions but cannot conclude on the efficacy of robenidine HCl in turkeys for fattening. The existing 5‐day withdrawal period to avoid off‐flavours in edible tissues should be maintained.
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spelling pubmed-70092052020-07-02 Safety and efficacy of Robenz(®) 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Kouba, Maryline Kos Durjava, Mojca López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Aquilina, Gabriele Bories, Georges Brantom, Paul Cocconcelli, Pier Sandro Halle, Ingrid Kolar, Boris Wester, Pieter van Beelen, Patrick Holczknecht, Orsolya Vettori, Maria Vittoria Gropp, Jürgen EFSA J Scientific Opinion Following a request from European Commission, the 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 Robenz(®) 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz(®) 66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a margin of safety of approximately 2.5. This conclusion is extrapolated to turkeys for fattening. Robenidine HCl is active against Gram‐positive but not against Gram‐negative bacteria. It is not expected that the use of robenidine HCl as a feed additive would induce resistance or cross‐resistance to antimicrobials used in human and animal therapy. The use of robenidine HCl from Robenz(®) 66G at the highest proposed level of 36 mg/kg complete feed in chickens and turkeys for fattening is considered safe for the consumer. The existing maximum residues limits for both avian species are confirmed. Robenidine HCl is not a skin or eye irritant and not a skin sensitiser. The risk via inhalation is considered negligible. The use of robenidine HCl from Robenz(®) in feed for chickens for fattening and turkeys for fattening up to 36 mg/kg complete feed does not pose a risk to either the terrestrial or the aquatic compartment. A risk for bioaccumulation cannot be excluded. The risk for secondary poisoning is not likely to occur. The FEEDAP Panel concludes that 36 mg robenidine HCl/kg complete feed from Robenz(®) 66G has the potential to effectively control coccidiosis of chickens for fattening under field conditions but cannot conclude on the efficacy of robenidine HCl in turkeys for fattening. The existing 5‐day withdrawal period to avoid off‐flavours in edible tissues should be maintained. John Wiley and Sons Inc. 2019-03-05 /pmc/articles/PMC7009205/ /pubmed/32626244 http://dx.doi.org/10.2903/j.efsa.2019.5613 Text en © 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://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
Kouba, Maryline
Kos Durjava, Mojca
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Aquilina, Gabriele
Bories, Georges
Brantom, Paul
Cocconcelli, Pier Sandro
Halle, Ingrid
Kolar, Boris
Wester, Pieter
van Beelen, Patrick
Holczknecht, Orsolya
Vettori, Maria Vittoria
Gropp, Jürgen
Safety and efficacy of Robenz(®) 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening
title Safety and efficacy of Robenz(®) 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening
title_full Safety and efficacy of Robenz(®) 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening
title_fullStr Safety and efficacy of Robenz(®) 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening
title_full_unstemmed Safety and efficacy of Robenz(®) 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening
title_short Safety and efficacy of Robenz(®) 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening
title_sort safety and efficacy of robenz(®) 66g (robenidine hydrochloride) for chickens for fattening and turkeys for fattening
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009205/
https://www.ncbi.nlm.nih.gov/pubmed/32626244
http://dx.doi.org/10.2903/j.efsa.2019.5613
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