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...
Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Wiley
2023-02-01
|
Series: | EFSA Journal |
Subjects: | |
Online Access: | https://doi.org/10.2903/j.efsa.2023.7818 |
_version_ | 1797848871458570240 |
---|---|
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. |
first_indexed | 2024-04-09T18:34:36Z |
format | Article |
id | doaj.art-c90d192e2ee740d09e225bb66ab4ba20 |
institution | Directory Open Access Journal |
issn | 1831-4732 |
language | English |
last_indexed | 2024-04-09T18:34:36Z |
publishDate | 2023-02-01 |
publisher | Wiley |
record_format | Article |
series | EFSA Journal |
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 |
work_keys_str_mv | AT efsapanelonadditivesandproductsorsubstancesusedinanimalfeedfeedap modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT vasileiosbampidis modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT giovannaazimonti modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT mariadelourdesbastos modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT henrikchristensen modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT birgitdusemund modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT mojcadurjava modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT marylinekouba modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT martalopezalonso modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT secundinolopezpuente modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT francescamarcon modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT baltasarmayo modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT alenapechova modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT marianapetkova modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT fernandoramos modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT yolandasanz modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT robertoedoardovilla modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT ruudwoutersen modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT rosellabrozzi modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT elisapettenati modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT joanarevez modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT montserratanguita modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT jaumegalobart modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd AT jordiortuno modificationoftheconditionsoftheauthorisationofclostridiumbutyricumfermbp2789miyagoldforchickensforfatteningchickensrearedforlayingandminoravianspeciesexcludinglayingbirdsmiyarisanpharmaceuticalcoltd |