Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the product Toyocerin® (Bacillus cereus var. Toyoi) as a feed additive for sows from service to weaning, in accordance with Regulation (EC) No 1831/2003

Toyocerin® is a zootechnical additive (functional group: gut flora stabilisers) composed of spores of a strain of Bacillus cereus isolated from soil mixed with maize flour and calcium carbonate. The product is permanently authorised for use with sows from one week prior to farrowing until weaning at a recommended dose range of 0.5 – 2.0 x 109 kg complete feedingstuff. The applicant is now seeking a change in the terms of the authorisation extending its period of use to cover the entire reproductive cycle (from service to weaning). EFSA has been asked by the European Commission to deliver an opinion on the efficacy and the safety for the target species, consumer, user and the environment of the product Toyocerin® when used under the revised conditions proposed by the applicant. The product, in addition to use with sows, is also authorised for use with piglets up to four months of age, and with pigs, cattle, chickens and rabbits for fattening. The safety of Toyocerin® for the target species (including sows), for consumers of food products of animals fed diets containing Toyocerin®, for users of the product and for the wider environment were established as part of the previous authorisations. The FEEDAP Panel is not aware of any additional data which would require a reconsideration of these safety assessments. The data provided by four new studies (three covering two reproductive cycles and one a single cycle) are consistent with the earlier studies assessed in conjunction with the existing authorisation and taken in combination would lead to the same conclusions in relation to piglet health. The use of Toyocerin® at the minimum recommended dose can increase numbers of live births, the number of piglets reaching weaning and increase their bodyweight at weaning. This appears associated, in part at least, with a reduced incidence or severity of diarrhoea during suckling and the subsequent post-weaning period. The FEEDAP Panel concludes, on the basis of the totality of data available, that use of Toyocerin® over the entire cycle produces significant benefits to the piglets. However, the FEEDAP Panel is unable to assess the additional benefits that might be provided by use of the additive over the entire reproductive cycle compared to the currently authorised period.