Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the microbiological product "035", a preparation of Bacillus subtilis, as a feed additive for chickens for fattening in accordance with Regulation (EC) No 1831/2003

The product 035 is a microbial feed additive based on a single strain of Bacillus subtilis. It is proposed as a zootechnical feed additive for chickens for fattening up to slaughter age at a dose range of 8 x 108 - 1.6 x 109 CFU kg(-1) complete feedingstuff. The European Food Safety Authority has been requested to deliver an opinion on the efficacy of the additive and its safety for the target animals, the consumer, the user of the product and the environment. Efficacy at the minimum recommended dose has been demonstrated in four of seven studies, in which a statistically significant improvement in the final weight was seen. The in vitro data provided by the applicant on compatibility with coccidiostats can be considered indicative but would need to be substantiated in vivo before reaching a conclusion. The FEEDAP Panel concludes that 035 is safe at the highest recommended level for chickens for fattening, with at least 100-fold margin of safety. The lack of toxigenic properties of the B. subtilis strain has been experimentally demonstrated. The consumer safety aspects were considered during the assessment for authorisation of BioPlus 2B, a product which contains the production strain and another Bacillus strain. The FEEDAP Panel is not aware of any new information that would require it to reconsider this assessment. As a proteinacious substance 035 may have a sensitizing potential, and adequate protection is recommended when handling the product. Since bacilli are common soil organisms and abundantly present in the environment, the product 035 is not of environmental concern.