Following a request from the European Commission, the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the safety and efficacy for the target animals, consumer, user and the environment of the product Ecobiol® (Bacillus amyloliquefaciens) used as a feed additive for chickens for fattening. Ecobiol® is a feed additive based on viable spores of a strain of Bacillus amyloliquefaciens, a species which EFSA recognises as having QPS status. The additive is prepared in two forms - Ecobiol® containing spores at 1 x 1012 CFU kg-1 product and Ecobiol® plus with ten-fold greater spore content (1 x 1013 CFU kg-1 product). The product is intended for use in chickens for fattening for the entire production period at a dose of 1 x 109 CFU kg-1 complete
feedingstuff. There is evidence from three independent studies that Ecobiol®, at the recommended dose, can significantly improve feed conversion in chickens for fattening. Ecobiol® and Ecobiol® plus are
considered equivalent when used to deliver the recommended dose.
The molecular method used (16S rDNA sequence) establishes the identity of the active agent as a strain of Bacillus amyloliquefaciens, and consequently the QPS approach can be taken to establish safety. The strain was shown not to possess the genes encoding Bacillus enterotoxins or the key gene implicated in the synthesis of emetic toxins, or otherwise not to demonstrate
phenotypic characteristics of toxin production. The strain was sensitive to antibiotics of human clinical and veterinary importance and did not produce substances affecting the growth of bacterial strains known to be sensitive to antibiotics in clinical use. Consequently, the strain meets the qualifications required by the QPS approach and the additive can be considered safe
for the target species, the consumers and the wider environment.
On the basis of the evidence presented, Ecobiol® can be considered to be non-irritant to the skin and eyes of the users and not to produce a skin sensitisation reaction via dermal route. However, it should be noted that those studies were carried out with Ecobiol® and not with Ecobiol® plus, the formulation with the higher microbial protein content. The FEEDAP Panel
concludes that, due to the nature of the product, Ecobiol® should be treated as a potential respiratory sensitiser.
