Scientific Opinion on the safety and efficacy of Rovabio((R)) Excel (endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase) as a feed additive for lactating sows EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

Rovabio (R) Excel is a preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase that is intended to be used as a feed additive for lactating sows, at a dose of 1 500 glucanase U and 1 100 xylanase U/kg feed, in order to minimise the mobilisation of body reserves of sows during lactation. The European Food Safety Authority issued an opinion on the safety and efficacy of Rovabio (R) Excel as a feed additive for chickens and turkeys for fattening, laying hens, piglets (weaned) and pigs for fattening, ducks, guinea fowl, quails, geese, pheasants and pigeons. The full description of the formulations, manufacturing processes, purity, stability and homogeneity of the product is given in that assessment. The FEEDAP Panel considers that the safety aspects, other than for the new target species, are covered in the previous assessment and would not be affected by the extension of use requested. The results of a tolerance study showed that 200-fold the recommended dose was tolerated well by the sows when offered for a period of seven weeks, including gestation and lactation. Therefore, the Panel concludes that the recommended dose is safe in lactating sows. The Panel cannot conclude on the efficacy of Rovabio (R) Excel from the available efficacy data. (C) European Food Safety Authority, 2014