Cargando…

Safety and efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase produced with Talaromyces versatilis IMI 378536 and DSM 26702 (ROVABIO(®) ADVANCE) for weaned piglets and pigs for fattening (ADISSEO France S.A.S)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ROVABIO(®) ADVANCE (liquid and solid) which contains endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase. The enzymes present in the additive are produced by two strains o...

Descripción completa

Detalles Bibliográficos
Autores principales: Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Dusemund, Birgit, Fašmon 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, Dierick, Noël, Martelli, Giovanna, Galobart, Jaume, Ortuño, Jordi, Anguita, Montserrat
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9084910/
https://www.ncbi.nlm.nih.gov/pubmed/35582368
http://dx.doi.org/10.2903/j.efsa.2022.7251
_version_ 1784703702893854720
author Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Fašmon 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
Dierick, Noël
Martelli, Giovanna
Galobart, Jaume
Ortuño, Jordi
Anguita, Montserrat
author_facet Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Fašmon 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
Dierick, Noël
Martelli, Giovanna
Galobart, Jaume
Ortuño, Jordi
Anguita, Montserrat
collection PubMed
description Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ROVABIO(®) ADVANCE (liquid and solid) which contains endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase. The enzymes present in the additive are produced by two strains of Talaromyces versatilis, one of them genetically modified. The additive is intended to be used as a feed additive for weaned piglets and pigs for fattening. Viable cells of the production strains and DNA of the genetically modified strain were not detected in the fermentation product used to formulate the additive. Based on the results of a tolerance trial in weaned piglets, the FEEDAP Panel concluded that ROVABIO(®) ADVANCE is safe for weaned piglets under the recommended conditions of use. This conclusion was extended to pigs for fattening. Based on the outcome of the toxicological studies performed, the Panel concluded that the additive is of no concern regarding consumer safety. ROVABIO(®) ADVANCE is not irritant to the skin or eyes but it is a skin and respiratory sensitiser. No risks to the environment are expected from the use of the additive in animal nutrition. Owing to the lack of sufficient data, the FEEDAP Panel could not conclude on the efficacy of ROVABIO(®) ADVANCE.
format Online
Article
Text
id pubmed-9084910
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher John Wiley and Sons Inc.
record_format MEDLINE/PubMed
spelling pubmed-90849102022-05-16 Safety and efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase produced with Talaromyces versatilis IMI 378536 and DSM 26702 (ROVABIO(®) ADVANCE) for weaned piglets and pigs for fattening (ADISSEO France S.A.S) Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Fašmon 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 Dierick, Noël Martelli, Giovanna Galobart, Jaume Ortuño, Jordi Anguita, Montserrat EFSA J Scientific Opinion Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ROVABIO(®) ADVANCE (liquid and solid) which contains endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase. The enzymes present in the additive are produced by two strains of Talaromyces versatilis, one of them genetically modified. The additive is intended to be used as a feed additive for weaned piglets and pigs for fattening. Viable cells of the production strains and DNA of the genetically modified strain were not detected in the fermentation product used to formulate the additive. Based on the results of a tolerance trial in weaned piglets, the FEEDAP Panel concluded that ROVABIO(®) ADVANCE is safe for weaned piglets under the recommended conditions of use. This conclusion was extended to pigs for fattening. Based on the outcome of the toxicological studies performed, the Panel concluded that the additive is of no concern regarding consumer safety. ROVABIO(®) ADVANCE is not irritant to the skin or eyes but it is a skin and respiratory sensitiser. No risks to the environment are expected from the use of the additive in animal nutrition. Owing to the lack of sufficient data, the FEEDAP Panel could not conclude on the efficacy of ROVABIO(®) ADVANCE. John Wiley and Sons Inc. 2022-05-09 /pmc/articles/PMC9084910/ /pubmed/35582368 http://dx.doi.org/10.2903/j.efsa.2022.7251 Text en © 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://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
Fašmon 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
Dierick, Noël
Martelli, Giovanna
Galobart, Jaume
Ortuño, Jordi
Anguita, Montserrat
Safety and efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase produced with Talaromyces versatilis IMI 378536 and DSM 26702 (ROVABIO(®) ADVANCE) for weaned piglets and pigs for fattening (ADISSEO France S.A.S)
title Safety and efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase produced with Talaromyces versatilis IMI 378536 and DSM 26702 (ROVABIO(®) ADVANCE) for weaned piglets and pigs for fattening (ADISSEO France S.A.S)
title_full Safety and efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase produced with Talaromyces versatilis IMI 378536 and DSM 26702 (ROVABIO(®) ADVANCE) for weaned piglets and pigs for fattening (ADISSEO France S.A.S)
title_fullStr Safety and efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase produced with Talaromyces versatilis IMI 378536 and DSM 26702 (ROVABIO(®) ADVANCE) for weaned piglets and pigs for fattening (ADISSEO France S.A.S)
title_full_unstemmed Safety and efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase produced with Talaromyces versatilis IMI 378536 and DSM 26702 (ROVABIO(®) ADVANCE) for weaned piglets and pigs for fattening (ADISSEO France S.A.S)
title_short Safety and efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase produced with Talaromyces versatilis IMI 378536 and DSM 26702 (ROVABIO(®) ADVANCE) for weaned piglets and pigs for fattening (ADISSEO France S.A.S)
title_sort safety and efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase produced with talaromyces versatilis imi 378536 and dsm 26702 (rovabio(®) advance) for weaned piglets and pigs for fattening (adisseo france s.a.s)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9084910/
https://www.ncbi.nlm.nih.gov/pubmed/35582368
http://dx.doi.org/10.2903/j.efsa.2022.7251
work_keys_str_mv AT safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT bampidisvasileios safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT azimontigiovanna safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT bastosmariadelourdes safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT christensenhenrik safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT dusemundbirgit safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT fasmondurjavamojca safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT koubamaryline safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT lopezalonsomarta safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT lopezpuentesecundino safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT marconfrancesca safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT mayobaltasar safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT pechovaalena safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT petkovamariana safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT ramosfernando safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT sanzyolanda safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT villarobertoedoardo safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT woutersenruud safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT diericknoel safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT martelligiovanna safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT galobartjaume safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT ortunojordi safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas
AT anguitamontserrat safetyandefficacyofafeedadditiveconsistingofendo14betaxylanaseandendo134betaglucanaseproducedwithtalaromycesversatilisimi378536anddsm26702rovabioadvanceforweanedpigletsandpigsforfatteningadisseofrancesas