Safety and efficacy of the product Toyocerin® ( Bacillus cereus var. toyoi) as feed additive for rabbit breeding does

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 of Toyocerin® (Bacillus cereus) used as a feed additive for rabbit breeding does. Toyocerin® is a zootechnical additive composed of spores of a strain of Bacillus cereus mixed with maize flour and calcium carbonate. The product has already been granted permanent or provisional authorisation for use with most livestock species and categories. In particular, Toyocerin® is already permanently authorised for use with rabbits for fattening and was provisionally authorised for use with breeding does. The applicant is now seeking authorisation for a period of ten years for the continuing use of Toyocerin® in diets for rabbit breeding does from service to weaning of kits (new-born rabbits). The recommended inclusion level is 0.2 – 1.0 x 109 CFU kg-1 complete feedingstuff, with the added condition that it may be used in compound feed containing the permitted coccidiostats robenidine and salinomycin sodium. The safety of Toyocerin® for consumers of food products derived from 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 those safety and practical assessments. Consequently, in this opinion are considered only the issues of safety and efficacy relevant to the use of the product in breeding does taking into account the previous provisional authorisation. There were significant benefits recorded in three efficacy trials with breeding does in which the minimum dose was included as a treatment. Two trials showed significantly reduced mortality of kits during lactation, one of them showing also improved kit and litter weights at weaning; the third trial showed clear benefits to the overall productivity, largely due to a reduction in intervals between mating. Significant benefits were also seen in three trials with the maximum recommended dose. The compatibility of Toyocerin® with the coccidiosats robenidine and salinomycin sodium can be reasonably presumed from their joint use in rabbits for fattening. The results of the tolerance study with rabbit breeding does taken with those of the more extensive study made with rabbits for fattening allows the FEEDAP Panel to conclude that Toyocerin® is safe for rabbit breeding does at the recommended dose range. However, the use of the product with breeding does cannot exclude the exposure of kits, for which there is limited direct evidence of tolerance to an overdose during the pre-weaning period. On balance, and considering the authorised use of Toyocerin® in many target species/categories, the FEEDAP Panel concludes that it is unlikely that an adverse response would be seen in suckling kits.