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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
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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. |
format | Online Article Text |
id | pubmed-7008785 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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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