Safety and efficacy of Axtra® XB 201 (endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase) as a feed additive for lactating sows and minor porcine species

Axtra® XB 201 is a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase to be used as a feed additive for lactating sows (major and minor species) and minor porcine species for meat production at the recommended dose of 1,220 U xylanase and 152 U glucanase per kg feed and 610 U xylanase and 76 U glucanase, respectively. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) adopted a scientific opinion on the safety and efficacy of this product as a zootechnical additive for poultry, piglets and pigs for fattening. Since aspects other than the safety and efficacy for the new target species/categories have been addressed previously, the current assessment addressed the safety and efficacy for the new target species only. Based on the results obtained in a tolerance trial in sows, the FEEDAP Panel concluded that the additive is safe for lactating sows at the recommended dose. The safety for piglets was previously established in a trial where piglets tolerated a 60-fold the recommended dose for minor porcine species for meat production. The Panel extrapolated the conclusions on the safety reached in major porcine species to minor porcine species. Seven efficacy trials in sows were submitted. In two short-term trials, the additive improved the apparent faecal digestibility of the dietary gross energy by the sows at the recommended dose. The same dose permitted to reduce the body weight loss of the sow during lactation in two long-term trials. Therefore, the Panel concluded that the additive has the potential to be efficacious in lactating sows at the recommended dose. In the previous opinion, the efficacy in piglets and pigs for fattening was established at the dose recommended for minor porcine species for meat production. The Panel extrapolated the conclusions reached in major porcine species to minor porcine species.