Calsporin® is a zootechnical feed additive (functional group: gut flora stabilizer) whose active ingredient is a strain of Bacillus subtilis. The additive is authorised under Regulation (EC) No 1831/2003 until 2016 for use in feed for chickens for fattening at a dose of 1 x 109 cfu kg-1 complete feedingstuff (equivalent to 100 mg product kg-1 complete feedingstuff). The applicant is now seeking authorisation to change the authorised dose by introducing a minimum dose of 5 x 108 cfu kg-1 complete feedingstuff (50 mg kg-1) and retaining the presently authorised dose as the maximum.
The FEEDAP Panel considers that the safety of the product for the target animal, consumers, users and the wider environment established at the highest dose covers the lowest dose proposed. Consequently, this opinion focuses only on the evidence of efficacy at the lowest dose.
Four trials were reported, each with a similar study design to allow for the possibility of a meta-analysis. In two of the four trials there was a statistically significant improvement in feed to gain ratio over the whole trial period. No other significant effects were seen. Analysis of the pooled data from the four trials showed that, overall, feed conversion was improved by 2.6 %. Consequently, the FEEDAP Panel concludes that there is evidence of efficacy at the lowest dose proposed.
