Cargando…
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
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 |
_version_ | 1783661583464923136 |
---|---|
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. |
format | Online Article Text |
id | pubmed-7938355 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci AT bampidisvasileios safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci AT azimontigiovanna safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci AT bastosmariadelourdes safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci AT christensenhenrik safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci AT dusemundbirgit safetyandefficacyofthefeedadditiveconsistingofclostridiumbutyricumfermbp2789miyagoldsforchickensforfatteningchickensrearedforlayingturkeysforfatteningturkeysrearedforbreedingminoravianspeciesexcludinglayingbirdspigletssucklingandweanedandminorporcinespeci 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 |