Modification of the conditions of the authorisation of Clostridium butyricum FERM BP‐2789 (Miya‐Gold®) for chickens for fattening, chickens reared for laying and minor avian species (excluding laying birds) (Miyarisan Pharmaceutical Co. Ltd)

Abstract The additive Miya‐Gold® consists of viable cells of Clostridium butyricum FERM BP‐2789.The additive is currently authorised in the EU for use as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (e...

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Main Authors: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa, Ruud Woutersen, Rosella Brozzi, Elisa Pettenati, Joana Revez, Montserrat Anguita, Jaume Galobart, Jordi Ortuño
Format: Article
Language:English
Published: Wiley 2023-02-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2023.7818
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author EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Vasileios Bampidis
Giovanna Azimonti
Maria de Lourdes Bastos
Henrik Christensen
Birgit Dusemund
Mojca Durjava
Maryline Kouba
Marta López‐Alonso
Secundino López Puente
Francesca Marcon
Baltasar Mayo
Alena Pechová
Mariana Petkova
Fernando Ramos
Yolanda Sanz
Roberto Edoardo Villa
Ruud Woutersen
Rosella Brozzi
Elisa Pettenati
Joana Revez
Montserrat Anguita
Jaume Galobart
Jordi Ortuño
author_facet EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Vasileios Bampidis
Giovanna Azimonti
Maria de Lourdes Bastos
Henrik Christensen
Birgit Dusemund
Mojca Durjava
Maryline Kouba
Marta López‐Alonso
Secundino López Puente
Francesca Marcon
Baltasar Mayo
Alena Pechová
Mariana Petkova
Fernando Ramos
Yolanda Sanz
Roberto Edoardo Villa
Ruud Woutersen
Rosella Brozzi
Elisa Pettenati
Joana Revez
Montserrat Anguita
Jaume Galobart
Jordi Ortuño
author_sort EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
collection DOAJ
description Abstract The additive Miya‐Gold® consists of viable cells of Clostridium butyricum FERM BP‐2789.The additive is currently authorised in the EU for use as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), piglets (suckling and weaned) and piglets of minor porcine species. The authorisation for chickens and minor poultry species for fattening and reared for laying is at a minimum level of 2.5 × 108 CFU/kg complete feed. The applicant has requested to lower this level to 1.25 × 108 CFU/kg feed. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) did not consider any of the five long‐term trials and one pooled analysis of two of them as supporting evidence for the efficacy of the additive at the lower dose due to the incompliance of the husbandry conditions in which the chickens were reared with those indicated in Directive 2007/43/EC. Owing to the lack of adequate data, the Panel is not in the position to conclude on the efficacy of Miya‐Gold® at 1.25 × 108 CFU/kg feed for the target species.
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spelling doaj.art-c90d192e2ee740d09e225bb66ab4ba202023-04-11T12:01:08ZengWileyEFSA Journal1831-47322023-02-01212n/an/a10.2903/j.efsa.2023.7818Modification of the conditions of the authorisation of Clostridium butyricum FERM BP‐2789 (Miya‐Gold®) for chickens for fattening, chickens reared for laying and minor avian species (excluding laying birds) (Miyarisan Pharmaceutical Co. Ltd)EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenBirgit DusemundMojca DurjavaMaryline KoubaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosYolanda SanzRoberto Edoardo VillaRuud WoutersenRosella BrozziElisa PettenatiJoana RevezMontserrat AnguitaJaume GalobartJordi OrtuñoAbstract The additive Miya‐Gold® consists of viable cells of Clostridium butyricum FERM BP‐2789.The additive is currently authorised in the EU for use as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), piglets (suckling and weaned) and piglets of minor porcine species. The authorisation for chickens and minor poultry species for fattening and reared for laying is at a minimum level of 2.5 × 108 CFU/kg complete feed. The applicant has requested to lower this level to 1.25 × 108 CFU/kg feed. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) did not consider any of the five long‐term trials and one pooled analysis of two of them as supporting evidence for the efficacy of the additive at the lower dose due to the incompliance of the husbandry conditions in which the chickens were reared with those indicated in Directive 2007/43/EC. Owing to the lack of adequate data, the Panel is not in the position to conclude on the efficacy of Miya‐Gold® at 1.25 × 108 CFU/kg feed for the target species.https://doi.org/10.2903/j.efsa.2023.7818zootechnical additivesgut flora stabiliserefficacypoultryMiya‐Gold®
spellingShingle EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Vasileios Bampidis
Giovanna Azimonti
Maria de Lourdes Bastos
Henrik Christensen
Birgit Dusemund
Mojca Durjava
Maryline Kouba
Marta López‐Alonso
Secundino López Puente
Francesca Marcon
Baltasar Mayo
Alena Pechová
Mariana Petkova
Fernando Ramos
Yolanda Sanz
Roberto Edoardo Villa
Ruud Woutersen
Rosella Brozzi
Elisa Pettenati
Joana Revez
Montserrat Anguita
Jaume Galobart
Jordi Ortuño
Modification of the conditions of the authorisation of Clostridium butyricum FERM BP‐2789 (Miya‐Gold®) for chickens for fattening, chickens reared for laying and minor avian species (excluding laying birds) (Miyarisan Pharmaceutical Co. Ltd)
EFSA Journal
zootechnical additives
gut flora stabiliser
efficacy
poultry
Miya‐Gold®
title Modification of the conditions of the authorisation of Clostridium butyricum FERM BP‐2789 (Miya‐Gold®) for chickens for fattening, chickens reared for laying and minor avian species (excluding laying birds) (Miyarisan Pharmaceutical Co. Ltd)
title_full Modification of the conditions of the authorisation of Clostridium butyricum FERM BP‐2789 (Miya‐Gold®) for chickens for fattening, chickens reared for laying and minor avian species (excluding laying birds) (Miyarisan Pharmaceutical Co. Ltd)
title_fullStr Modification of the conditions of the authorisation of Clostridium butyricum FERM BP‐2789 (Miya‐Gold®) for chickens for fattening, chickens reared for laying and minor avian species (excluding laying birds) (Miyarisan Pharmaceutical Co. Ltd)
title_full_unstemmed Modification of the conditions of the authorisation of Clostridium butyricum FERM BP‐2789 (Miya‐Gold®) for chickens for fattening, chickens reared for laying and minor avian species (excluding laying birds) (Miyarisan Pharmaceutical Co. Ltd)
title_short Modification of the conditions of the authorisation of Clostridium butyricum FERM BP‐2789 (Miya‐Gold®) for chickens for fattening, chickens reared for laying and minor avian species (excluding laying birds) (Miyarisan Pharmaceutical Co. Ltd)
title_sort modification of the conditions of the authorisation of clostridium butyricum ferm bp 2789 miya gold r for chickens for fattening chickens reared for laying and minor avian species excluding laying birds miyarisan pharmaceutical co ltd
topic zootechnical additives
gut flora stabiliser
efficacy
poultry
Miya‐Gold®
url https://doi.org/10.2903/j.efsa.2023.7818
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