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Safety and efficacy of the feed additive consisting of Clostridium butyricum FERM BP‐2789 (Miya‐Gold(®) S) 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 minor porcine species (Miyarisan Pharmaceutical Co. Ltd.)

The feed additive under assessment (trade name: Miya‐Gold(®) S) is based on viable spores of Clostridium butyricum FERM BP‐2789. It is authorised for use in minor avian species (excluding laying birds), weaned piglets and minor weaned porcine species, chickens reared for laying, turkeys for fattenin...

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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, Cocconcelli, Pier Sandro, Glandorf, Boet, Herman, Lieve, Maradona, Miguel Prieto, Saarela, Maria, Anguita, Montserrat, Galobart, Jaume, Holczknecht, Orsolya, Manini, Paola, Pizzo, Fabiola, Tarrés‐Call, Jordi, Pettenati, Elisa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938355/
https://www.ncbi.nlm.nih.gov/pubmed/33732396
http://dx.doi.org/10.2903/j.efsa.2021.6450
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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
Cocconcelli, Pier Sandro
Glandorf, Boet
Herman, Lieve
Maradona, Miguel Prieto
Saarela, Maria
Anguita, Montserrat
Galobart, Jaume
Holczknecht, Orsolya
Manini, Paola
Pizzo, Fabiola
Tarrés‐Call, Jordi
Pettenati, Elisa
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
Cocconcelli, Pier Sandro
Glandorf, Boet
Herman, Lieve
Maradona, Miguel Prieto
Saarela, Maria
Anguita, Montserrat
Galobart, Jaume
Holczknecht, Orsolya
Manini, Paola
Pizzo, Fabiola
Tarrés‐Call, Jordi
Pettenati, Elisa
collection PubMed
description The feed additive under assessment (trade name: Miya‐Gold(®) S) is based on viable spores of Clostridium butyricum FERM BP‐2789. It is authorised for use in minor avian species (excluding laying birds), weaned piglets and minor weaned porcine species, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. This opinion concerns the request for renewal of the authorisation of Miya‐Gold(®) S for the species/categories for which an authorisation exists, the use in chickens for fattening, for which the previous authorisation had expired, and the extension of use to suckling piglets and suckling minor porcine species. The applicant provided evidence that the additive currently in the market complies with the conditions of authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that Miya‐Gold(®) S remains safe for the animal species/categories, the consumer and the environment under the current and previously authorised conditions of use. This conclusion applies also to the new target species for which a request of use is made. Regarding the safety for the user, the Panel concluded that the additive is not irritant to skin and eyes and that sensitisation via respiratory route cannot be excluded. There is no need for assessing the efficacy of Miya‐Gold(®) S in the context of the renewal of the authorisation in chickens reared for laying, turkeys for fattening and reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species. The additive has the potential to be efficacious in chickens for fattening, suckling piglets and suckling minor porcine species at the level of 2.5 × 10(8) CFU/kg complete feedingstuff. Miya‐Gold(®) S is compatible with decoquinate, diclazuril, lasalocid, maduramicin ammonium, narasin, narasin/nicarbazin, monensin sodium, robenidine, salinomycin sodium and semduramicin.
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spelling pubmed-79383552021-03-16 Safety and efficacy of the feed additive consisting of Clostridium butyricum FERM BP‐2789 (Miya‐Gold(®) S) 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 minor porcine species (Miyarisan Pharmaceutical Co. Ltd.) 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 Cocconcelli, Pier Sandro Glandorf, Boet Herman, Lieve Maradona, Miguel Prieto Saarela, Maria Anguita, Montserrat Galobart, Jaume Holczknecht, Orsolya Manini, Paola Pizzo, Fabiola Tarrés‐Call, Jordi Pettenati, Elisa EFSA J Scientific Opinion The feed additive under assessment (trade name: Miya‐Gold(®) S) is based on viable spores of Clostridium butyricum FERM BP‐2789. It is authorised for use in minor avian species (excluding laying birds), weaned piglets and minor weaned porcine species, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. This opinion concerns the request for renewal of the authorisation of Miya‐Gold(®) S for the species/categories for which an authorisation exists, the use in chickens for fattening, for which the previous authorisation had expired, and the extension of use to suckling piglets and suckling minor porcine species. The applicant provided evidence that the additive currently in the market complies with the conditions of authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that Miya‐Gold(®) S remains safe for the animal species/categories, the consumer and the environment under the current and previously authorised conditions of use. This conclusion applies also to the new target species for which a request of use is made. Regarding the safety for the user, the Panel concluded that the additive is not irritant to skin and eyes and that sensitisation via respiratory route cannot be excluded. There is no need for assessing the efficacy of Miya‐Gold(®) S in the context of the renewal of the authorisation in chickens reared for laying, turkeys for fattening and reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species. The additive has the potential to be efficacious in chickens for fattening, suckling piglets and suckling minor porcine species at the level of 2.5 × 10(8) CFU/kg complete feedingstuff. Miya‐Gold(®) S is compatible with decoquinate, diclazuril, lasalocid, maduramicin ammonium, narasin, narasin/nicarbazin, monensin sodium, robenidine, salinomycin sodium and semduramicin. John Wiley and Sons Inc. 2021-03-08 /pmc/articles/PMC7938355/ /pubmed/33732396 http://dx.doi.org/10.2903/j.efsa.2021.6450 Text en © 2021 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
Cocconcelli, Pier Sandro
Glandorf, Boet
Herman, Lieve
Maradona, Miguel Prieto
Saarela, Maria
Anguita, Montserrat
Galobart, Jaume
Holczknecht, Orsolya
Manini, Paola
Pizzo, Fabiola
Tarrés‐Call, Jordi
Pettenati, Elisa
Safety and efficacy of the feed additive consisting of Clostridium butyricum FERM BP‐2789 (Miya‐Gold(®) S) 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 minor porcine species (Miyarisan Pharmaceutical Co. Ltd.)
title Safety and efficacy of the feed additive consisting of Clostridium butyricum FERM BP‐2789 (Miya‐Gold(®) S) 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 minor porcine species (Miyarisan Pharmaceutical Co. Ltd.)
title_full Safety and efficacy of the feed additive consisting of Clostridium butyricum FERM BP‐2789 (Miya‐Gold(®) S) 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 minor porcine species (Miyarisan Pharmaceutical Co. Ltd.)
title_fullStr Safety and efficacy of the feed additive consisting of Clostridium butyricum FERM BP‐2789 (Miya‐Gold(®) S) 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 minor porcine species (Miyarisan Pharmaceutical Co. Ltd.)
title_full_unstemmed Safety and efficacy of the feed additive consisting of Clostridium butyricum FERM BP‐2789 (Miya‐Gold(®) S) 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 minor porcine species (Miyarisan Pharmaceutical Co. Ltd.)
title_short Safety and efficacy of the feed additive consisting of Clostridium butyricum FERM BP‐2789 (Miya‐Gold(®) S) 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 minor porcine species (Miyarisan Pharmaceutical Co. Ltd.)
title_sort safety and efficacy of the feed additive consisting of clostridium butyricum ferm bp‐2789 (miya‐gold(®) s) 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 minor porcine species (miyarisan pharmaceutical co. ltd.)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938355/
https://www.ncbi.nlm.nih.gov/pubmed/33732396
http://dx.doi.org/10.2903/j.efsa.2021.6450
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AT koubamaryline safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT kosdurjavamojca safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT lopezalonsomarta safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT lopezpuentesecundino safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT marconfrancesca safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT mayobaltasar safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT pechovaalena safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT petkovamariana safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT ramosfernando safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT sanzyolanda safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT villarobertoedoardo safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT woutersenruud safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT cocconcellipiersandro safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT glandorfboet safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT hermanlieve safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT maradonamiguelprieto safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT saarelamaria safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT anguitamontserrat safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT galobartjaume safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT holczknechtorsolya safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT maninipaola safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT pizzofabiola safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT tarrescalljordi safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci
AT pettenatielisa safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci