Safety and efficacy of Toyocerin® ( Bacillus cereus var. Toyoi) as a feed additive for turkeys

Toyocerin® is a zootechnical additive (functional group: gut flora stabilisers) composed of spores of a strain of Bacillus cereus. The product has already been granted permanent authorisation for use in piglets up to four months of age, in pigs for fattening and in sows from one week prior to farrowing until weaning. It is also permanently authorised for use in cattle, chickens and rabbits for fattening and is provisionally authorised for use in laying hens, calves and breeding does. The applicant is now seeking authorisation for the use of Toyocerin® in diets for turkeys from one day of age to slaughter at an inclusion level of 0.2 – 1.0 x 109 CFU kg-1 complete feedingstuff. The safety of Toyocerin® for consumers of food products of animals fed diets containing Toyocerin®, for users of the product and for the wider environment has been established as part of the previous authorisations. The FEEDAP Panel is not aware of any additional data which would require a reconsideration of these assessments. Consequently, in this opinion, only the issues of safety and efficacy introduced by the extension of use to turkeys for fattening are considered. Efficacy at the highest recommended dose (1 x 109 CFU kg-1) has been demonstrated in all four studies in which the dose was tested. Four studies also incorporated the lowest recommended dose (0.2 x 109 CFU kg-1) with significant improvements in relevant parameters in three of the trials. However, two of the three studies in which significant benefits were seen involved the slow-growing Bronze turkey and only one trial a breed and growth rate more typical of European production systems. The degree to which results obtained with the slow-growing Bronze turkey can be extrapolated to other breeds and production systems in practice is open to question. However, the FEEDAP Panel considers that, on balance, the minimum recommended dose (0.2 x 109) is effective in turkeys for fattening. No specific data on the compatibility of Toyocerin® with authorised coccidiostats in turkeys was presented. However, the FEEDAP Panel considers it is reasonable to assume that compatibilities established in chickens for fattening would also apply to turkeys for fattening. Based on the two tolerance studies provided in which turkeys tolerated up to a ten-fold overdose of the product, and the known tolerance to substantially higher doses shown by chickens for fattening, the FEEDAP Panel considers that Toyocerin® is safe for turkeys when used at the maximum recommended dose.