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Assessment of the application for renewal of authorisation of ECONASE (®) XT (endo‐1,4‐β‐xylanase) as a feed additive for piglets (weaned), chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding

ECONASE (®) XT is an enzyme based on endo‐1,4‐β‐xylanase produced by a genetically modified strain of Trichoderma reesei ■■■■■. The additive is currently authorised for use in chickens for fattening or reared for laying, turkeys for fattening or reared for breeding, laying hens, weaned piglets, pigs...

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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, Mayo, Baltasar, Pechová, Alena, Petkova, Mariana, Ramos, Fernando, Sanz, Yolanda, Villa, Roberto, Woutersen, Ruud, Cocconcelli, Pier Sandro, Glandorf, Boet, Herman, Lieve, Prieto, Miguel Maradona, Saarela, Maria, Galobart, Jaume, Gregoretti, Lucilla, Innocenti, Matteo Lorenzo, López Gálvez, Gloria, Sofianidis, Konstantinos, Vettori, Maria Vittoria, Brozzi, Rosella
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/PMC7008785/
https://www.ncbi.nlm.nih.gov/pubmed/32626168
http://dx.doi.org/10.2903/j.efsa.2019.5880
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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
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto
Woutersen, Ruud
Cocconcelli, Pier Sandro
Glandorf, Boet
Herman, Lieve
Prieto, Miguel Maradona
Saarela, Maria
Galobart, Jaume
Gregoretti, Lucilla
Innocenti, Matteo Lorenzo
López Gálvez, Gloria
Sofianidis, Konstantinos
Vettori, Maria Vittoria
Brozzi, Rosella
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
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto
Woutersen, Ruud
Cocconcelli, Pier Sandro
Glandorf, Boet
Herman, Lieve
Prieto, Miguel Maradona
Saarela, Maria
Galobart, Jaume
Gregoretti, Lucilla
Innocenti, Matteo Lorenzo
López Gálvez, Gloria
Sofianidis, Konstantinos
Vettori, Maria Vittoria
Brozzi, Rosella
collection PubMed
description ECONASE (®) XT is an enzyme based on endo‐1,4‐β‐xylanase produced by a genetically modified strain of Trichoderma reesei ■■■■■. The additive is currently authorised for use in chickens for fattening or reared for laying, turkeys for fattening or reared for breeding, laying hens, weaned piglets, pigs for fattening and minor poultry species. This scientific opinion concerns the renewal of the authorisation of the additive when used in weaned piglets, chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. ECONASE (®) XT is currently authorised in two forms, a solid and a liquid form with activities of 4,000,000 and 400,000 BXU/g, respectively. The current application also comprises three new less concentrated formulations. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The Panel could not exclude the potential presence of recombinant DNA derived from the production organism in recent batches. However, since no sequences of concern have been introduced in the production strain, the potential presence of recombinant DNA in the final product does not raise any safety concern. No new evidence has been produced that would lead the Panel to reconsider its previous conclusions on the safety of the product for target species, consumers, users and the environment under the authorised conditions of use. Therefore, the FEEDAP Panel confirms that ECONASE (®) XT is safe for the target species, consumers of products from animals fed the additive and the environment. ECONASE (®) XT is non‐irritant to the skin, the liquid form is non‐irritant to the eyes and is not a dermal sensitiser, but the additive in all forms should be considered a potential respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
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spelling pubmed-70087852020-07-02 Assessment of the application for renewal of authorisation of ECONASE (®) XT (endo‐1,4‐β‐xylanase) as a feed additive for piglets (weaned), chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding 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 Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Woutersen, Ruud Cocconcelli, Pier Sandro Glandorf, Boet Herman, Lieve Prieto, Miguel Maradona Saarela, Maria Galobart, Jaume Gregoretti, Lucilla Innocenti, Matteo Lorenzo López Gálvez, Gloria Sofianidis, Konstantinos Vettori, Maria Vittoria Brozzi, Rosella EFSA J Scientific Opinion ECONASE (®) XT is an enzyme based on endo‐1,4‐β‐xylanase produced by a genetically modified strain of Trichoderma reesei ■■■■■. The additive is currently authorised for use in chickens for fattening or reared for laying, turkeys for fattening or reared for breeding, laying hens, weaned piglets, pigs for fattening and minor poultry species. This scientific opinion concerns the renewal of the authorisation of the additive when used in weaned piglets, chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. ECONASE (®) XT is currently authorised in two forms, a solid and a liquid form with activities of 4,000,000 and 400,000 BXU/g, respectively. The current application also comprises three new less concentrated formulations. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The Panel could not exclude the potential presence of recombinant DNA derived from the production organism in recent batches. However, since no sequences of concern have been introduced in the production strain, the potential presence of recombinant DNA in the final product does not raise any safety concern. No new evidence has been produced that would lead the Panel to reconsider its previous conclusions on the safety of the product for target species, consumers, users and the environment under the authorised conditions of use. Therefore, the FEEDAP Panel confirms that ECONASE (®) XT is safe for the target species, consumers of products from animals fed the additive and the environment. ECONASE (®) XT is non‐irritant to the skin, the liquid form is non‐irritant to the eyes and is not a dermal sensitiser, but the additive in all forms should be considered a potential respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. John Wiley and Sons Inc. 2019-11-07 /pmc/articles/PMC7008785/ /pubmed/32626168 http://dx.doi.org/10.2903/j.efsa.2019.5880 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
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto
Woutersen, Ruud
Cocconcelli, Pier Sandro
Glandorf, Boet
Herman, Lieve
Prieto, Miguel Maradona
Saarela, Maria
Galobart, Jaume
Gregoretti, Lucilla
Innocenti, Matteo Lorenzo
López Gálvez, Gloria
Sofianidis, Konstantinos
Vettori, Maria Vittoria
Brozzi, Rosella
Assessment of the application for renewal of authorisation of ECONASE (®) XT (endo‐1,4‐β‐xylanase) as a feed additive for piglets (weaned), chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding
title Assessment of the application for renewal of authorisation of ECONASE (®) XT (endo‐1,4‐β‐xylanase) as a feed additive for piglets (weaned), chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding
title_full Assessment of the application for renewal of authorisation of ECONASE (®) XT (endo‐1,4‐β‐xylanase) as a feed additive for piglets (weaned), chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding
title_fullStr Assessment of the application for renewal of authorisation of ECONASE (®) XT (endo‐1,4‐β‐xylanase) as a feed additive for piglets (weaned), chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding
title_full_unstemmed Assessment of the application for renewal of authorisation of ECONASE (®) XT (endo‐1,4‐β‐xylanase) as a feed additive for piglets (weaned), chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding
title_short Assessment of the application for renewal of authorisation of ECONASE (®) XT (endo‐1,4‐β‐xylanase) as a feed additive for piglets (weaned), chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding
title_sort assessment of the application for renewal of authorisation of econase (®) xt (endo‐1,4‐β‐xylanase) as a feed additive for piglets (weaned), chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008785/
https://www.ncbi.nlm.nih.gov/pubmed/32626168
http://dx.doi.org/10.2903/j.efsa.2019.5880
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