Safety and efficacy of a feed additive consisting of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 (GalliPro® Fit & GalliPro® Fit 10) for all poultry (Chr. Hansen A/S)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of <i>Bacillus subtilis</i> DSM 32324, <i>B. subtilis</i> DSM 32325 and <i>Bacillus amyloliquefaciens</i> DSM 25840 (GalliPro® Fit 10) as a zootechnical feed additive for all poultry species. The additive in a less concentrated form (GalliPro® Fit) is already authorised for use in feed and water for drinking for poultry for fattening, reared for laying or reared for breeding. With the current application, the applicant is seeking the authorisation for use in feed and water for drinking for all poultry. In addition, the applicant is seeking the modification of the terms of the existing authorisation by introducing a new formulation with a 10-fold increased concentration of the active agents in the additive (from 3.2 × 10<sup>9</sup> to 3.2 × 10<sup>10</sup> colony forming units (CFU)/g additive). The FEEDAP Panel concluded that the additive is considered safe for the target species, including poultry species for laying and breeding, consumers and the environment at the proposed conditions of use. Both forms of the additive are non-irritant to the eyes but are considered skin and respiratory sensitisers, and any exposure through skin and respiratory tract is considered a risk. The additive has the potential to be efficacious as a zootechnical additive in all poultry at 1.6 × 10<sup>9</sup> CFU/kg feed and 5.4 × 10<sup>8</sup> CFU/L water for drinking.

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Publication Details

Journal
EFSA Journal
Published
2025-04-01
DOI
https://doi.org/10.2903/j.efsa.2025.9361
Citations
1
Primary Topic
Agricultural safety and regulations
Type
article
Field-Weighted Citation Impact
1.16

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article

Safety and efficacy of a feed additive consisting of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 (GalliPro® Fit & GalliPro® Fit 10) for all poultry (Chr. Hansen A/S)

Ilen Röhe, Paul Brantom, Alena Pechová, Eleftherios Bonos et al.
1 citations
EFSA Journal
Agricultural safety and regulations
1.16
article

Safety and efficacy of a feed additive consisting of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 (GalliPro® Fit & GalliPro® Fit 10) for all poultry (Chr. Hansen A/S)

Ilen Röhe, Paul Brantom, Alena Pechová, Eleftherios Bonos, Henrik Christensen, Roberto Edoardo Villa, Katerina Theodoridou, Marta López‐Alonso, Francesca Marcon, Ronette Gehring, Jordi Ortuño, Carlo Nebbia, Miguel Prieto Maradona, Matteo Lorenzo Innocenti, Mojca Fašmon Durjava, Maryline Kouba, Boet Glandorf, Rosella Brozzi, Giovanna Azimonti, Birgit Dusemund, Lieve Herman, Montserrat Anguita, Jaume Galobart
article en
1 citations

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of <i>Bacillus subtilis</i> DSM 32324, <i>B. subtilis</i> DSM 32325 and <i>Bacillus amyloliquefaciens</i> DSM 25840 (GalliPro® Fit 10) as a zootechnical feed additive for all poultry species. The additive in a less concentrated form (GalliPro® Fit) is already authorised for use in feed and water for drinking for poultry for fattening, reared for laying or reared for breeding. With the current application, the applicant is seeking the authorisation for use in feed and water for drinking for all poultry. In addition, the applicant is seeking the modification of the terms of the existing authorisation by introducing a new formulation with a 10-fold increased concentration of the active agents in the additive (from 3.2 × 10<sup>9</sup> to 3.2 × 10<sup>10</sup> colony forming units (CFU)/g additive). The FEEDAP Panel concluded that the additive is considered safe for the target species, including poultry species for laying and breeding, consumers and the environment at the proposed conditions of use. Both forms of the additive are non-irritant to the eyes but are considered skin and respiratory sensitisers, and any exposure through skin and respiratory tract is considered a risk. The additive has the potential to be efficacious as a zootechnical additive in all poultry at 1.6 × 10<sup>9</sup> CFU/kg feed and 5.4 × 10<sup>8</sup> CFU/L water for drinking.

EFSA JournalVol. 23(4)
European Food Safety Authority
Clean water and sanitation
Openalex Percentile: Top 23%
Agricultural safety and regulations
1.16
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