Scientific Opinion on the safety and efficacy of Toyocerin® ( Bacillus cereus) as a feed additive for sows, piglets, pigs for fattening, cattle for fattening, calves for rearing, chickens for fattening and rabbits for fattening

Toyocerin® is an additive containing spores of a strain of Bacillus cereus intended to be applied to animal feed to improve performance. On the basis of the studies provided, the Panel concludes that the additive is well tolerated by the various categories of pigs, cattle, chickens and rabbits that are the subject of this request for authorisation/re-evaluation. However, the strain shows resistance to two antibiotics, one of which at least can be ascribed to an acquired resistance. For this reason the FEEDAP Panel considers it inadvisable to introduce into target species a resistance determinant capable of transfer to other bacterial strains. Analysis of the complete genome sequence showed that the strain harbours all of the genes coding for non-haemolytic and haemolytic enterotoxins. Since the two operons present the same organisation as pathogenic B. cereus strains and since no mutation affecting transcription or translation has been detected, it has to be assumed that the Toyocerin® strain has the capacity to elaborate functional toxins and, thus, to pose a hazard for those exposed to the organism. This would include those handling the additive and consumers inadvertently exposed to contaminated animal products. The additive is non-irritant to eyes, and by extension, to the skin but should be treated as a sensitiser and, in particular, as hazardous to the respiratory tract. B. cereus is a ubiquitous soil saprophyte. Consequently, use of the strain in animal nutrition is not expected to measurably increase numbers of the organism in the environment. The addition of Toyocerin® to the feed has the potential to improve at least one aspect of production in chickens for fattening; pigs for fattening; sows, calves; cattle for fattening and rabbits for fattening. Insufficient data was available to conclude on the efficacy of Toyocerin® when used in diets for weaned piglets.