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Assessment of the application for renewal of the authorisation of PHYZYME (®) XP 10000 TPT/L (6‐phytase) as a feed additive for all avian species and all swine species

PHYZYME (®) XP 10000 TPT/L is a feed additive that contains 6‐phytase produced by a genetically modified strain of Schizosaccharomyces pombe. The applicant requested for the renewal of the authorisation for PHYZYME (®) XP 10000 TPT and L to be used as a feed additive for avian species for fattening/...

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Autores principales: Bampidis, Vasileios, Azimonti, Giovanna, de Lourdes Bastos, Maria, Christensen, Henrik, Dusemund, Birgit, Kouba, Maryline, Kos Durjava, Mojca, López‐Alonso, Marta, López Puente, Secundino, Marcon, Francesca, Pechová, Alena, Petkova, Mariana, Ramos, Fernando, Sanz, Yolanda, Villa, Roberto Edoardo, Woutersen, Ruud, Anguita, Montserrat, Pettenati, Elisa, Mayo, Baltasar
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/PMC7009065/
https://www.ncbi.nlm.nih.gov/pubmed/32626324
http://dx.doi.org/10.2903/j.efsa.2019.5702
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author Bampidis, Vasileios
Azimonti, Giovanna
de Lourdes Bastos, Maria
Christensen, Henrik
Dusemund, Birgit
Kouba, Maryline
Kos Durjava, Mojca
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Anguita, Montserrat
Pettenati, Elisa
Mayo, Baltasar
author_facet Bampidis, Vasileios
Azimonti, Giovanna
de Lourdes Bastos, Maria
Christensen, Henrik
Dusemund, Birgit
Kouba, Maryline
Kos Durjava, Mojca
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Anguita, Montserrat
Pettenati, Elisa
Mayo, Baltasar
collection PubMed
description PHYZYME (®) XP 10000 TPT/L is a feed additive that contains 6‐phytase produced by a genetically modified strain of Schizosaccharomyces pombe. The applicant requested for the renewal of the authorisation for PHYZYME (®) XP 10000 TPT and L to be used as a feed additive for avian species for fattening/laying, weaned piglets, pigs for fattening and sows and for an extension of use to avian species reared for laying/breeding, suckling piglets and minor porcine species. To support the request or the renewal of the authorisation, the applicant provided evidence that the additive in the market complies with the conditions of the authorisation. According to the information provided by the applicant, no new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions regarding the safety for the target species, consumer, user and environment. The application for renewal of the authorisation did not include a proposal for amending the conditions of use in those species for which an authorisation exists that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. Regarding the new species/categories, the Panel concluded that the additive is safe and has a potential to be efficacious in avian species reared for laying/breeding at 250 FTU/kg feed and for suckling piglets and minor porcine species at 500 FTU/kg feed.
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spelling pubmed-70090652020-07-02 Assessment of the application for renewal of the authorisation of PHYZYME (®) XP 10000 TPT/L (6‐phytase) as a feed additive for all avian species and all swine species Bampidis, Vasileios Azimonti, Giovanna de Lourdes Bastos, Maria Christensen, Henrik Dusemund, Birgit Kouba, Maryline Kos Durjava, Mojca López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Anguita, Montserrat Pettenati, Elisa Mayo, Baltasar EFSA J Scientific Opinion PHYZYME (®) XP 10000 TPT/L is a feed additive that contains 6‐phytase produced by a genetically modified strain of Schizosaccharomyces pombe. The applicant requested for the renewal of the authorisation for PHYZYME (®) XP 10000 TPT and L to be used as a feed additive for avian species for fattening/laying, weaned piglets, pigs for fattening and sows and for an extension of use to avian species reared for laying/breeding, suckling piglets and minor porcine species. To support the request or the renewal of the authorisation, the applicant provided evidence that the additive in the market complies with the conditions of the authorisation. According to the information provided by the applicant, no new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions regarding the safety for the target species, consumer, user and environment. The application for renewal of the authorisation did not include a proposal for amending the conditions of use in those species for which an authorisation exists that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. Regarding the new species/categories, the Panel concluded that the additive is safe and has a potential to be efficacious in avian species reared for laying/breeding at 250 FTU/kg feed and for suckling piglets and minor porcine species at 500 FTU/kg feed. John Wiley and Sons Inc. 2019-05-10 /pmc/articles/PMC7009065/ /pubmed/32626324 http://dx.doi.org/10.2903/j.efsa.2019.5702 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
de Lourdes Bastos, Maria
Christensen, Henrik
Dusemund, Birgit
Kouba, Maryline
Kos Durjava, Mojca
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Anguita, Montserrat
Pettenati, Elisa
Mayo, Baltasar
Assessment of the application for renewal of the authorisation of PHYZYME (®) XP 10000 TPT/L (6‐phytase) as a feed additive for all avian species and all swine species
title Assessment of the application for renewal of the authorisation of PHYZYME (®) XP 10000 TPT/L (6‐phytase) as a feed additive for all avian species and all swine species
title_full Assessment of the application for renewal of the authorisation of PHYZYME (®) XP 10000 TPT/L (6‐phytase) as a feed additive for all avian species and all swine species
title_fullStr Assessment of the application for renewal of the authorisation of PHYZYME (®) XP 10000 TPT/L (6‐phytase) as a feed additive for all avian species and all swine species
title_full_unstemmed Assessment of the application for renewal of the authorisation of PHYZYME (®) XP 10000 TPT/L (6‐phytase) as a feed additive for all avian species and all swine species
title_short Assessment of the application for renewal of the authorisation of PHYZYME (®) XP 10000 TPT/L (6‐phytase) as a feed additive for all avian species and all swine species
title_sort assessment of the application for renewal of the authorisation of phyzyme (®) xp 10000 tpt/l (6‐phytase) as a feed additive for all avian species and all swine species
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009065/
https://www.ncbi.nlm.nih.gov/pubmed/32626324
http://dx.doi.org/10.2903/j.efsa.2019.5702
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