Assessment on the Safety and Efficacy of a Feed Additive Consisting of <i>Bacillus subtilis</i> DSM 32324, <i>Bacillus subtilis</i> DSM 32325 and <i>Bacillus amyloliquefaciens</i> DSM 25840 (GalliPro® Fit &amp; GalliPro® Fit 10) for All Poultry (Chr.

An application was submitted to the Food Standards Agency and Food Standards Scotland in January 2024 from Chr. Hansen A/S (“the applicant”) for the authorisation of an additive consisting of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840, under the category of ‘zootechnical additive’ and functional group ‘gut flora stabiliser’ for a supplementary use in feed and water for laying hens and other poultry kept for egg production or breeding. The applicant also seeks authorisation for the modification of the terms of the existing authorisation by introducing a new formulation with a 10-fold increase in concentration of the active agents in the additive (from 3.2 × 10 9 to 3.2 × 10 10 colony forming units (CFU)/g additive). Additionally, the applicant is seeking the authorisation for use in feed and water for drinking for all poultry. In 2025, the European Food Safety Authority (EFSA) published a scientific opinion on the safety and efficacy of a feed additive consisting of B. subtilis DSM 32324, B. subtilis DSM 32325 and B. amyloliquefaciens DSM 25840 (EFSA FEEDAP Panel, 2025). The FEEDAP Panel concluded that the additive is safe for the target species (including poultry species for laying and breeding), the environment and consumers when used under the proposed conditions of use. Both forms of the additive are non-irritant to the eyes but are considered skin and respiratory sensitisers. It was also concluded that the additive has the potential to be efficacious as a zootechnical additive in all poultry at 1.6 × 10 9 CFU/kg feed and 5.4 × 10 8 CFU/L water for drinking. The FSA/FSS have reviewed the applicant’s authorisation application, supporting documentation, and other regulators’ risk assessments, most notably the EFSA risk assessment opinion, and considers sufficient evidence has been demonstrated to conclude without the need for further questions or risk assessment.