Assessment of the feed additive consisting of Enterococcus lactis DSM 7134 (Bonvital®) for sows for the renewal of its authorisation (Lactosan GmbH & Co.KG)

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of Bonvital® as a zootechnical additive for sows. Bonvital® is currently authorised for use in weaned piglets, pigs for fatt...

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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, Pier Sandro Cocconcelli, Montserrat Anguita, Jaume Galobart, Matteo L. Innocenti, Rosella Brozzi
Format: Article
Language:English
Published: Wiley 2025-04-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2025.9353
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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
Pier Sandro Cocconcelli
Montserrat Anguita
Jaume Galobart
Matteo L. Innocenti
Rosella Brozzi
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
Pier Sandro Cocconcelli
Montserrat Anguita
Jaume Galobart
Matteo L. Innocenti
Rosella Brozzi
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 assessment of the application for renewal of the authorisation of Bonvital® as a zootechnical additive for sows. Bonvital® is currently authorised for use in weaned piglets, pigs for fattening, sows, chickens for fattening, laying hens, chickens reared for laying and minor poultry species (other than those used for laying). The active agent of Bonvital® was originally identified as Enterococcus faecium. In a previous opinion the strain was reassigned to Enterococcus lactis. The applicant provided evidence that the additive currently on the market complies with the existing terms of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for the target species, consumers and the environment under the authorised conditions of use. Bonvital® in its powder form is not irritant to the skin and eyes but no conclusion is possible for the granulated form. Bonvital® should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. There is no need to assess the efficacy of Bonvital® in the context of the renewal of the authorisation.
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publishDate 2025-04-01
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spelling doaj-art-294f6b3873ed44e5a212864d4ce69c832025-08-20T03:33:17ZengWileyEFSA Journal1831-47322025-04-01234n/an/a10.2903/j.efsa.2025.9353Assessment of the feed additive consisting of Enterococcus lactis DSM 7134 (Bonvital®) for sows for the renewal of its authorisation (Lactosan GmbH & Co.KG)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 TheodoridouPier Sandro CocconcelliMontserrat AnguitaJaume GalobartMatteo L. InnocentiRosella BrozziAbstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of Bonvital® as a zootechnical additive for sows. Bonvital® is currently authorised for use in weaned piglets, pigs for fattening, sows, chickens for fattening, laying hens, chickens reared for laying and minor poultry species (other than those used for laying). The active agent of Bonvital® was originally identified as Enterococcus faecium. In a previous opinion the strain was reassigned to Enterococcus lactis. The applicant provided evidence that the additive currently on the market complies with the existing terms of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for the target species, consumers and the environment under the authorised conditions of use. Bonvital® in its powder form is not irritant to the skin and eyes but no conclusion is possible for the granulated form. Bonvital® should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. There is no need to assess the efficacy of Bonvital® in the context of the renewal of the authorisation.https://doi.org/10.2903/j.efsa.2025.9353Enterococcus lactis DSM 7134gut flora stabilisersafetysowszootechnical 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
Pier Sandro Cocconcelli
Montserrat Anguita
Jaume Galobart
Matteo L. Innocenti
Rosella Brozzi
Assessment of the feed additive consisting of Enterococcus lactis DSM 7134 (Bonvital®) for sows for the renewal of its authorisation (Lactosan GmbH & Co.KG)
EFSA Journal
Enterococcus lactis DSM 7134
gut flora stabiliser
safety
sows
zootechnical additives
title Assessment of the feed additive consisting of Enterococcus lactis DSM 7134 (Bonvital®) for sows for the renewal of its authorisation (Lactosan GmbH & Co.KG)
title_full Assessment of the feed additive consisting of Enterococcus lactis DSM 7134 (Bonvital®) for sows for the renewal of its authorisation (Lactosan GmbH & Co.KG)
title_fullStr Assessment of the feed additive consisting of Enterococcus lactis DSM 7134 (Bonvital®) for sows for the renewal of its authorisation (Lactosan GmbH & Co.KG)
title_full_unstemmed Assessment of the feed additive consisting of Enterococcus lactis DSM 7134 (Bonvital®) for sows for the renewal of its authorisation (Lactosan GmbH & Co.KG)
title_short Assessment of the feed additive consisting of Enterococcus lactis DSM 7134 (Bonvital®) for sows for the renewal of its authorisation (Lactosan GmbH & Co.KG)
title_sort assessment of the feed additive consisting of enterococcus lactis dsm 7134 bonvital r for sows for the renewal of its authorisation lactosan gmbh co kg
topic Enterococcus lactis DSM 7134
gut flora stabiliser
safety
sows
zootechnical additives
url https://doi.org/10.2903/j.efsa.2025.9353
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