Cargando…
Safety and efficacy of FRA (®) Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening
The product FRA (®) Octazyme C Dry contains eight enzymes and is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. In a previous opinion of the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the additive was characterised...
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/PMC7009080/ https://www.ncbi.nlm.nih.gov/pubmed/32626352 http://dx.doi.org/10.2903/j.efsa.2019.5730 |
_version_ | 1783495586860761088 |
---|---|
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 Edoardo Woutersen, Ruud Anguita, Montserrat |
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 Edoardo Woutersen, Ruud Anguita, Montserrat |
collection | PubMed |
description | The product FRA (®) Octazyme C Dry contains eight enzymes and is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. In a previous opinion of the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the additive was characterised in full, including the production strains of the enzymes, the safety and the efficacy of the product. In that assessment, the FEEDAP Panel concluded that the additive was safe for the consumers of food products obtained from animals fed with the additive and that the additive would pose no risks to the environment. Regarding the safety for the users, the Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties, but the additive should be considered a potential respiratory sensitiser. In the trials submitted to support the safety for the target species and the efficacy of the additive, the analytical results of the enzyme activities did not confirm the intended enzyme activities and therefore the FEEDAP Panel could not draw conclusions on the tolerance and the efficacy of the additive. In the current application, the applicant has provided new analysis of the feeds used in the tolerance and efficacy trials. The data have been obtained using a modified extraction procedure which has demonstrated to permit a higher recovery of the enzyme activity in supplemented and non‐supplemented feeds. However, the enzyme activities obtained in the experimental diets using the new analytical method showed increases but also decreases of the enzyme activity compared to the previously submitted data. Therefore, the change in the enzyme activities could not be ascribed to the analytical method only. The Panel concluded that the new data cannot be considered as those reflecting the actual supplementation levels of the additive in the diets and therefore could not conclude on the safety and efficacy of the target species. |
format | Online Article Text |
id | pubmed-7009080 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-70090802020-07-02 Safety and efficacy of FRA (®) Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening 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 Edoardo Woutersen, Ruud Anguita, Montserrat EFSA J Scientific Opinion The product FRA (®) Octazyme C Dry contains eight enzymes and is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. In a previous opinion of the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the additive was characterised in full, including the production strains of the enzymes, the safety and the efficacy of the product. In that assessment, the FEEDAP Panel concluded that the additive was safe for the consumers of food products obtained from animals fed with the additive and that the additive would pose no risks to the environment. Regarding the safety for the users, the Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties, but the additive should be considered a potential respiratory sensitiser. In the trials submitted to support the safety for the target species and the efficacy of the additive, the analytical results of the enzyme activities did not confirm the intended enzyme activities and therefore the FEEDAP Panel could not draw conclusions on the tolerance and the efficacy of the additive. In the current application, the applicant has provided new analysis of the feeds used in the tolerance and efficacy trials. The data have been obtained using a modified extraction procedure which has demonstrated to permit a higher recovery of the enzyme activity in supplemented and non‐supplemented feeds. However, the enzyme activities obtained in the experimental diets using the new analytical method showed increases but also decreases of the enzyme activity compared to the previously submitted data. Therefore, the change in the enzyme activities could not be ascribed to the analytical method only. The Panel concluded that the new data cannot be considered as those reflecting the actual supplementation levels of the additive in the diets and therefore could not conclude on the safety and efficacy of the target species. John Wiley and Sons Inc. 2019-06-18 /pmc/articles/PMC7009080/ /pubmed/32626352 http://dx.doi.org/10.2903/j.efsa.2019.5730 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 Edoardo Woutersen, Ruud Anguita, Montserrat Safety and efficacy of FRA (®) Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening |
title | Safety and efficacy of FRA
(®) Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening |
title_full | Safety and efficacy of FRA
(®) Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening |
title_fullStr | Safety and efficacy of FRA
(®) Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening |
title_full_unstemmed | Safety and efficacy of FRA
(®) Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening |
title_short | Safety and efficacy of FRA
(®) Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening |
title_sort | safety and efficacy of fra
(®) octazyme c dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009080/ https://www.ncbi.nlm.nih.gov/pubmed/32626352 http://dx.doi.org/10.2903/j.efsa.2019.5730 |
work_keys_str_mv | AT safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT bampidisvasileios safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT azimontigiovanna safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT delourdesbastosmaria safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT christensenhenrik safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT dusemundbirgit safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT koubamaryline safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT kosdurjavamojca safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT lopezalonsomarta safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT lopezpuentesecundino safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT marconfrancesca safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT mayobaltasar safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT pechovaalena safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT petkovamariana safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT ramosfernando safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT sanzyolanda safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT villarobertoedoardo safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT woutersenruud safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening AT anguitamontserrat safetyandefficacyoffraoctazymecdryendo14bxylanasemannanendo14bmannosidaseaamylaseendo134bglucanasepectinaseendo14bglucanaseproteaseagalactosidaseasafeedadditiveforweanedpigletsandchickensforfattening |