Assessment of the feed additive consisting of endo‐1,3(4)‐beta‐glucanase and endo‐1,4‐beta‐xylanase (produced with Talaromyces versatilis IMI CC 378536) (Rovabio® Excel) for all poultry species, weaned piglets, pigs for fattening and sows for the renewal of its authorisation (Adisseo France SAS)

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of endo‐1,3(4)‐beta‐glucanase and endo‐1,4‐beta‐xylanase (produced with Talaromyces versatilis IMI CC 378536) (Rovabio® Excel) for the...

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Main Authors: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López‐Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto‐Maradona, Ilen Röhe, Katerina Theodoridou, Paul Brantom, Andrey Yurkov, Montserrat Anguita, Matteo L. Innocenti, Jordi Tarrés‐Call, Elisa Pettenati
Format: Article
Language:English
Published: Wiley 2025-01-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2025.9131
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author EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Roberto Edoardo Villa
Giovanna Azimonti
Eleftherios Bonos
Henrik Christensen
Mojca Durjava
Birgit Dusemund
Ronette Gehring
Boet Glandorf
Maryline Kouba
Marta López‐Alonso
Francesca Marcon
Carlo Nebbia
Alena Pechová
Miguel Prieto‐Maradona
Ilen Röhe
Katerina Theodoridou
Paul Brantom
Andrey Yurkov
Montserrat Anguita
Matteo L. Innocenti
Jordi Tarrés‐Call
Elisa Pettenati
author_facet EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Roberto Edoardo Villa
Giovanna Azimonti
Eleftherios Bonos
Henrik Christensen
Mojca Durjava
Birgit Dusemund
Ronette Gehring
Boet Glandorf
Maryline Kouba
Marta López‐Alonso
Francesca Marcon
Carlo Nebbia
Alena Pechová
Miguel Prieto‐Maradona
Ilen Röhe
Katerina Theodoridou
Paul Brantom
Andrey Yurkov
Montserrat Anguita
Matteo L. Innocenti
Jordi Tarrés‐Call
Elisa Pettenati
author_sort EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
collection DOAJ
description Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of endo‐1,3(4)‐beta‐glucanase and endo‐1,4‐beta‐xylanase (produced with Talaromyces versatilis IMI CC 378536) (Rovabio® Excel) for the renewal of its authorisation as a zootechnical feed additive for all poultry species, weaned piglets, pigs for fattening and sows. The applicant provided evidence that the additive complies with the conditions of the authorisation. The FEEDAP Panel concluded that the additive in all its formulations remains safe for all poultry species, weaned piglets, pigs for fattening and sows, and remains safe for consumers and the environment. Regarding user safety, all the forms of the additive are non‐irritant to the eyes or skin. Rovabio® Excel LC2 and Rovabio® Excel LC are not dermal sensitisers. Rovabio® AP and Rovabio® Excel AP T‐Flex should be considered dermal sensitisers; therefore, exposure to these forms of the additive by dermal routes is considered a risk. All the forms of the additive are considered respiratory sensitisers; any exposure by inhalation is considered a risk. 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 doaj-art-48b2d29b9d1440c49f7d19e9837377ca2025-01-31T12:06:04ZengWileyEFSA Journal1831-47322025-01-01231n/an/a10.2903/j.efsa.2025.9131Assessment of the feed additive consisting of endo‐1,3(4)‐beta‐glucanase and endo‐1,4‐beta‐xylanase (produced with Talaromyces versatilis IMI CC 378536) (Rovabio® Excel) for all poultry species, weaned piglets, pigs for fattening and sows for the renewal of its authorisation (Adisseo France SAS)EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Roberto Edoardo VillaGiovanna AzimontiEleftherios BonosHenrik ChristensenMojca DurjavaBirgit DusemundRonette GehringBoet GlandorfMaryline KoubaMarta López‐AlonsoFrancesca MarconCarlo NebbiaAlena PechováMiguel Prieto‐MaradonaIlen RöheKaterina TheodoridouPaul BrantomAndrey YurkovMontserrat AnguitaMatteo L. InnocentiJordi Tarrés‐CallElisa PettenatiAbstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of endo‐1,3(4)‐beta‐glucanase and endo‐1,4‐beta‐xylanase (produced with Talaromyces versatilis IMI CC 378536) (Rovabio® Excel) for the renewal of its authorisation as a zootechnical feed additive for all poultry species, weaned piglets, pigs for fattening and sows. The applicant provided evidence that the additive complies with the conditions of the authorisation. The FEEDAP Panel concluded that the additive in all its formulations remains safe for all poultry species, weaned piglets, pigs for fattening and sows, and remains safe for consumers and the environment. Regarding user safety, all the forms of the additive are non‐irritant to the eyes or skin. Rovabio® Excel LC2 and Rovabio® Excel LC are not dermal sensitisers. Rovabio® AP and Rovabio® Excel AP T‐Flex should be considered dermal sensitisers; therefore, exposure to these forms of the additive by dermal routes is considered a risk. All the forms of the additive are considered respiratory sensitisers; any exposure by inhalation is considered a risk. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.https://doi.org/10.2903/j.efsa.2025.9131digestibility enhancerspigspoultryRovabio® excelsafetyzootechnical additives
spellingShingle EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Roberto Edoardo Villa
Giovanna Azimonti
Eleftherios Bonos
Henrik Christensen
Mojca Durjava
Birgit Dusemund
Ronette Gehring
Boet Glandorf
Maryline Kouba
Marta López‐Alonso
Francesca Marcon
Carlo Nebbia
Alena Pechová
Miguel Prieto‐Maradona
Ilen Röhe
Katerina Theodoridou
Paul Brantom
Andrey Yurkov
Montserrat Anguita
Matteo L. Innocenti
Jordi Tarrés‐Call
Elisa Pettenati
Assessment of the feed additive consisting of endo‐1,3(4)‐beta‐glucanase and endo‐1,4‐beta‐xylanase (produced with Talaromyces versatilis IMI CC 378536) (Rovabio® Excel) for all poultry species, weaned piglets, pigs for fattening and sows for the renewal of its authorisation (Adisseo France SAS)
EFSA Journal
digestibility enhancers
pigs
poultry
Rovabio® excel
safety
zootechnical additives
title Assessment of the feed additive consisting of endo‐1,3(4)‐beta‐glucanase and endo‐1,4‐beta‐xylanase (produced with Talaromyces versatilis IMI CC 378536) (Rovabio® Excel) for all poultry species, weaned piglets, pigs for fattening and sows for the renewal of its authorisation (Adisseo France SAS)
title_full Assessment of the feed additive consisting of endo‐1,3(4)‐beta‐glucanase and endo‐1,4‐beta‐xylanase (produced with Talaromyces versatilis IMI CC 378536) (Rovabio® Excel) for all poultry species, weaned piglets, pigs for fattening and sows for the renewal of its authorisation (Adisseo France SAS)
title_fullStr Assessment of the feed additive consisting of endo‐1,3(4)‐beta‐glucanase and endo‐1,4‐beta‐xylanase (produced with Talaromyces versatilis IMI CC 378536) (Rovabio® Excel) for all poultry species, weaned piglets, pigs for fattening and sows for the renewal of its authorisation (Adisseo France SAS)
title_full_unstemmed Assessment of the feed additive consisting of endo‐1,3(4)‐beta‐glucanase and endo‐1,4‐beta‐xylanase (produced with Talaromyces versatilis IMI CC 378536) (Rovabio® Excel) for all poultry species, weaned piglets, pigs for fattening and sows for the renewal of its authorisation (Adisseo France SAS)
title_short Assessment of the feed additive consisting of endo‐1,3(4)‐beta‐glucanase and endo‐1,4‐beta‐xylanase (produced with Talaromyces versatilis IMI CC 378536) (Rovabio® Excel) for all poultry species, weaned piglets, pigs for fattening and sows for the renewal of its authorisation (Adisseo France SAS)
title_sort assessment of the feed additive consisting of endo 1 3 4 beta glucanase and endo 1 4 beta xylanase produced with talaromyces versatilis imi cc 378536 rovabio r excel for all poultry species weaned piglets pigs for fattening and sows for the renewal of its authorisation adisseo france sas
topic digestibility enhancers
pigs
poultry
Rovabio® excel
safety
zootechnical additives
url https://doi.org/10.2903/j.efsa.2025.9131
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AT alenapechova assessmentofthefeedadditiveconsistingofendo134betaglucanaseandendo14betaxylanaseproducedwithtalaromycesversatilisimicc378536rovabioexcelforallpoultryspeciesweanedpigletspigsforfatteningandsowsfortherenewalofitsauthorisationadisseofrancesas
AT miguelprietomaradona assessmentofthefeedadditiveconsistingofendo134betaglucanaseandendo14betaxylanaseproducedwithtalaromycesversatilisimicc378536rovabioexcelforallpoultryspeciesweanedpigletspigsforfatteningandsowsfortherenewalofitsauthorisationadisseofrancesas
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AT paulbrantom assessmentofthefeedadditiveconsistingofendo134betaglucanaseandendo14betaxylanaseproducedwithtalaromycesversatilisimicc378536rovabioexcelforallpoultryspeciesweanedpigletspigsforfatteningandsowsfortherenewalofitsauthorisationadisseofrancesas
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AT montserratanguita assessmentofthefeedadditiveconsistingofendo134betaglucanaseandendo14betaxylanaseproducedwithtalaromycesversatilisimicc378536rovabioexcelforallpoultryspeciesweanedpigletspigsforfatteningandsowsfortherenewalofitsauthorisationadisseofrancesas
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