Cargando…
Safety and efficacy of RONOZYME (®) WX CT/L (endo‐1,4‐β‐xylanase) as a feed additive for sows for reproduction
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of RONOZYME (®) WX CT/L as a feed additive for sows for reproduction. This additive contains endo‐1,4‐...
Autores principales: | , , , , , , , , , , , , , , , , , , |
---|---|
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/PMC7009274/ https://www.ncbi.nlm.nih.gov/pubmed/32626410 http://dx.doi.org/10.2903/j.efsa.2019.5790 |
_version_ | 1783495633206771712 |
---|---|
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 Pettenati, Elisa Anguita, Montserrat |
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 Pettenati, Elisa Anguita, Montserrat |
collection | PubMed |
description | Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of RONOZYME (®) WX CT/L as a feed additive for sows for reproduction. This additive contains endo‐1,4‐β‐xylanase produced by a genetically modified strain of Aspergillus oryzae and it is authorised in the EU as a feed additive for poultry for fattening, weaned piglets and pigs for fattening. The applicant requests the extension of use of the additive to sows for reproduction at 200 FXU/kg feed. The FEEDAP Panel concluded that there are no concerns for consumer safety and no risks for the environment are expected from the use of RONOZYME (®) WX in sows. The FEEDAP Panel concluded that the additive is not a skin or eye irritant, but it should be considered a respiratory sensitiser, but could not conclude on the skin sensitisation potential of the additive. A tolerance trial in lactating sows and two toxicological studies were made available to support the safety of the target species. Based on the data available, the FEEDAP Panel concluded that the additive is safe for sows for reproduction at the recommended level with a wide margin of safety. Three efficacy studies in lactating sows were evaluated. Sows that received RONOZYME (®) WX showed improvements on the apparent faecal digestibility of the energy in the three trials. The enzyme activity in feed that showed efficacy ranged from 124 to 287 FXU/kg feed, and the FEEDAP Panel concluded that the additive has the potential to be efficacious as a zootechnical additive in lactating sows at a level of approximately 250 FXU/kg feed. No data has been provided in gestating sows, and consequently, the Panel could not conclude on this physiological stage of the productive cycle. |
format | Online Article Text |
id | pubmed-7009274 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-70092742020-07-02 Safety and efficacy of RONOZYME (®) WX CT/L (endo‐1,4‐β‐xylanase) as a feed additive for sows for reproduction 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 Pettenati, Elisa Anguita, Montserrat EFSA J Scientific Opinion Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of RONOZYME (®) WX CT/L as a feed additive for sows for reproduction. This additive contains endo‐1,4‐β‐xylanase produced by a genetically modified strain of Aspergillus oryzae and it is authorised in the EU as a feed additive for poultry for fattening, weaned piglets and pigs for fattening. The applicant requests the extension of use of the additive to sows for reproduction at 200 FXU/kg feed. The FEEDAP Panel concluded that there are no concerns for consumer safety and no risks for the environment are expected from the use of RONOZYME (®) WX in sows. The FEEDAP Panel concluded that the additive is not a skin or eye irritant, but it should be considered a respiratory sensitiser, but could not conclude on the skin sensitisation potential of the additive. A tolerance trial in lactating sows and two toxicological studies were made available to support the safety of the target species. Based on the data available, the FEEDAP Panel concluded that the additive is safe for sows for reproduction at the recommended level with a wide margin of safety. Three efficacy studies in lactating sows were evaluated. Sows that received RONOZYME (®) WX showed improvements on the apparent faecal digestibility of the energy in the three trials. The enzyme activity in feed that showed efficacy ranged from 124 to 287 FXU/kg feed, and the FEEDAP Panel concluded that the additive has the potential to be efficacious as a zootechnical additive in lactating sows at a level of approximately 250 FXU/kg feed. No data has been provided in gestating sows, and consequently, the Panel could not conclude on this physiological stage of the productive cycle. John Wiley and Sons Inc. 2019-08-12 /pmc/articles/PMC7009274/ /pubmed/32626410 http://dx.doi.org/10.2903/j.efsa.2019.5790 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 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 Pettenati, Elisa Anguita, Montserrat Safety and efficacy of RONOZYME (®) WX CT/L (endo‐1,4‐β‐xylanase) as a feed additive for sows for reproduction |
title | Safety and efficacy of RONOZYME
(®)
WX CT/L (endo‐1,4‐β‐xylanase) as a feed additive for sows for reproduction |
title_full | Safety and efficacy of RONOZYME
(®)
WX CT/L (endo‐1,4‐β‐xylanase) as a feed additive for sows for reproduction |
title_fullStr | Safety and efficacy of RONOZYME
(®)
WX CT/L (endo‐1,4‐β‐xylanase) as a feed additive for sows for reproduction |
title_full_unstemmed | Safety and efficacy of RONOZYME
(®)
WX CT/L (endo‐1,4‐β‐xylanase) as a feed additive for sows for reproduction |
title_short | Safety and efficacy of RONOZYME
(®)
WX CT/L (endo‐1,4‐β‐xylanase) as a feed additive for sows for reproduction |
title_sort | safety and efficacy of ronozyme
(®)
wx ct/l (endo‐1,4‐β‐xylanase) as a feed additive for sows for reproduction |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009274/ https://www.ncbi.nlm.nih.gov/pubmed/32626410 http://dx.doi.org/10.2903/j.efsa.2019.5790 |
work_keys_str_mv | AT safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT bampidisvasileios safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT azimontigiovanna safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT bastosmariadelourdes safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT christensenhenrik safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT dusemundbirgit safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT koubamaryline safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT kosdurjavamojca safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT lopezalonsomarta safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT lopezpuentesecundino safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT marconfrancesca safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT mayobaltasar safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT pechovaalena safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT petkovamariana safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT ramosfernando safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT sanzyolanda safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT villarobertoedoardo safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT woutersenruud safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT pettenatielisa safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction AT anguitamontserrat safetyandefficacyofronozymewxctlendo14bxylanaseasafeedadditiveforsowsforreproduction |