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

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 <i>Enterococcus faecium</i>. In a previous opinion the strain was reassigned to <i>Enterococcus lactis</i>. 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.

Authors

Publication Details

Journal
EFSA Journal
Published
2025-04-01
DOI
https://doi.org/10.2903/j.efsa.2025.9353
Primary Topic
Agricultural safety and regulations
Type
article
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article

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

Ilen Röhe, Alena Pechová, Eleftherios Bonos, Henrik Christensen et al.
EFSA Journal
Agricultural safety and regulations
article

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

Ilen Röhe, Alena Pechová, Eleftherios Bonos, Henrik Christensen, Roberto Edoardo Villa, Katerina Theodoridou, Marta López‐Alonso, Francesca Marcon, Ronette Gehring, Miguel Prieto Maradona, Mojca Durjava, Pier Sandro Cocconcelli, Rosella Brozzi, Maryline Kouba, Boet Glandorf, Carlo Nebbia, Giovanna Azimonti, Birgit Dusemund, Montserrat Anguita, Jaume Galobart, Matteo L. Innocenti
article en

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 <i>Enterococcus faecium</i>. In a previous opinion the strain was reassigned to <i>Enterococcus lactis</i>. 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.

EFSA JournalVol. 23(4)
Life in Land
Openalex Percentile: Top 91%
Agricultural safety and regulations
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