The additive GalliPro is a microbial feed additive based on Bacillus subtilis. The additive is currently authorised for use in feeds for chickens for fattening at the minimum dose of 8 x 108 and a maximum of 1.6 x 109 CFU/kg of complete feedingstuffs. The applicant is now seeking the modification of the existing authorisation to include a more
concentrated formulation, guaranteeing a minimum concentration of Bacillus subtilis of 1.6 x 1010 CFU/g additive. This would be used to deliver the same dose as presently authorised. The applicant is also seeking the authorisation for the simultaneous use of the product with formic acid.
B. subtilis is considered by the European Food Safety Authority (EFSA) to be suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment. In the course of previous assessments the strain was considered to satisfy the qualifications specified for the species, and so can be treated as meeting the requirements of the QPS approach. Consequently, no further assessment of safety for the target species, the consumer and the environment is required. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the modification to the formulation of GalliPro® proposed (minimum concentration of 1.6 x 1010 CFU /g of additive) is considered unlikely to introduce hazards not already considered as part of the first assessment.
The compatibility of the active agent with formic acid up to 2600 mg/kg was demonstrated when the product strain B. subtilis was used in combination with a strain of B. licheniformis in an in vivo experiment with chickens for fattening. Since the dose of B. subtilis tested was equivalent to the minimum authorised dose, and as differential counts for the two Bacillus strains were provided, the compatibility with formic acid demonstrated in this experiment can be extrapolated to GalliPro®.
