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Safety and efficacy of Avizyme(®) 1505 (endo‐1,4‐beta‐xylanase, subtilisin and alpha‐amylase) for all poultry species

Avizyme(®) 1505 is based on three enzyme activities produced by three genetically modified microorganisms: xylanase, subtilisin and amylase produced by Trichoderma reesei, Bacillus subtilis and Bacillus amyloliquefaciens, respectively. It is authorised for use in chickens and turkeys for fattening,...

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Autores principales: Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Dusemund, Birgit, Kos Durjava, Mojca, Kouba, Maryline, 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, Galobart, Jaume, Holczknecht, Orsolya, Manini, Paola, Pizzo, Fabiola, Tarrés‐Call, Jordi, Anguita, Montserrat, Pettenati, Elisa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448027/
https://www.ncbi.nlm.nih.gov/pubmed/32874236
http://dx.doi.org/10.2903/j.efsa.2020.6027
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author Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Kos Durjava, Mojca
Kouba, Maryline
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
Galobart, Jaume
Holczknecht, Orsolya
Manini, Paola
Pizzo, Fabiola
Tarrés‐Call, Jordi
Anguita, Montserrat
Pettenati, Elisa
author_facet Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Kos Durjava, Mojca
Kouba, Maryline
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
Galobart, Jaume
Holczknecht, Orsolya
Manini, Paola
Pizzo, Fabiola
Tarrés‐Call, Jordi
Anguita, Montserrat
Pettenati, Elisa
collection PubMed
description Avizyme(®) 1505 is based on three enzyme activities produced by three genetically modified microorganisms: xylanase, subtilisin and amylase produced by Trichoderma reesei, Bacillus subtilis and Bacillus amyloliquefaciens, respectively. It is authorised for use in chickens and turkeys for fattening, ducks and laying hens. This scientific opinion concerns the request for the renewal of the authorisation of the additive for the species/categories for which there is an authorisation, a reduction of the minimum recommended level in turkeys for fattening and the extension of use to all avian species for laying, for fattening, reared for breeding and reared for laying (except for ducks). Based on recent data, uncertainty remains in the characterisation of the production strains and the possible presence in the final product of viable production strains and their DNA. Therefore, the EFSA Panel on Additives and products or Substances used in Animal Feed (FEEDAP) could not confirm the conclusions previously drawn regarding the safety of Avizyme(®) 1505 for the target species, consumers, users and environment. This conclusion applies also to the new target species for which a request for an extension of use is made. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for chickens for fattening, ducks and laying hens. The efficacy data previously evaluated allowed the Panel to conclude that the additive has the potential to be efficacious at 187.5 U xylanase, 2,500 U subtilisin and 250 U amylase/kg complete feed for all avian species for fattening (including turkeys), reared for breeding and reared for laying and 300 U xylanase, 4,000 U subtilisin and 400 U amylase/kg complete feed in all avian species for laying.
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spelling pubmed-74480272020-08-31 Safety and efficacy of Avizyme(®) 1505 (endo‐1,4‐beta‐xylanase, subtilisin and alpha‐amylase) for all poultry species Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Kos Durjava, Mojca Kouba, Maryline 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 Galobart, Jaume Holczknecht, Orsolya Manini, Paola Pizzo, Fabiola Tarrés‐Call, Jordi Anguita, Montserrat Pettenati, Elisa EFSA J Scientific Opinion Avizyme(®) 1505 is based on three enzyme activities produced by three genetically modified microorganisms: xylanase, subtilisin and amylase produced by Trichoderma reesei, Bacillus subtilis and Bacillus amyloliquefaciens, respectively. It is authorised for use in chickens and turkeys for fattening, ducks and laying hens. This scientific opinion concerns the request for the renewal of the authorisation of the additive for the species/categories for which there is an authorisation, a reduction of the minimum recommended level in turkeys for fattening and the extension of use to all avian species for laying, for fattening, reared for breeding and reared for laying (except for ducks). Based on recent data, uncertainty remains in the characterisation of the production strains and the possible presence in the final product of viable production strains and their DNA. Therefore, the EFSA Panel on Additives and products or Substances used in Animal Feed (FEEDAP) could not confirm the conclusions previously drawn regarding the safety of Avizyme(®) 1505 for the target species, consumers, users and environment. This conclusion applies also to the new target species for which a request for an extension of use is made. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for chickens for fattening, ducks and laying hens. The efficacy data previously evaluated allowed the Panel to conclude that the additive has the potential to be efficacious at 187.5 U xylanase, 2,500 U subtilisin and 250 U amylase/kg complete feed for all avian species for fattening (including turkeys), reared for breeding and reared for laying and 300 U xylanase, 4,000 U subtilisin and 400 U amylase/kg complete feed in all avian species for laying. John Wiley and Sons Inc. 2020-02-21 /pmc/articles/PMC7448027/ /pubmed/32874236 http://dx.doi.org/10.2903/j.efsa.2020.6027 Text en © 2020 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
Kos Durjava, Mojca
Kouba, Maryline
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
Galobart, Jaume
Holczknecht, Orsolya
Manini, Paola
Pizzo, Fabiola
Tarrés‐Call, Jordi
Anguita, Montserrat
Pettenati, Elisa
Safety and efficacy of Avizyme(®) 1505 (endo‐1,4‐beta‐xylanase, subtilisin and alpha‐amylase) for all poultry species
title Safety and efficacy of Avizyme(®) 1505 (endo‐1,4‐beta‐xylanase, subtilisin and alpha‐amylase) for all poultry species
title_full Safety and efficacy of Avizyme(®) 1505 (endo‐1,4‐beta‐xylanase, subtilisin and alpha‐amylase) for all poultry species
title_fullStr Safety and efficacy of Avizyme(®) 1505 (endo‐1,4‐beta‐xylanase, subtilisin and alpha‐amylase) for all poultry species
title_full_unstemmed Safety and efficacy of Avizyme(®) 1505 (endo‐1,4‐beta‐xylanase, subtilisin and alpha‐amylase) for all poultry species
title_short Safety and efficacy of Avizyme(®) 1505 (endo‐1,4‐beta‐xylanase, subtilisin and alpha‐amylase) for all poultry species
title_sort safety and efficacy of avizyme(®) 1505 (endo‐1,4‐beta‐xylanase, subtilisin and alpha‐amylase) for all poultry species
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448027/
https://www.ncbi.nlm.nih.gov/pubmed/32874236
http://dx.doi.org/10.2903/j.efsa.2020.6027
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