Safety and efficacy of Econase XT P/L as feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and piglets (weaned)

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) and the Panel on Genetically Modified Organisms (GMO) were asked to issue a scientific opinion on the safety and efficacy of Econase XT P/L as feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and piglets (weaned). Econase XT is an enzyme feed additive with endo-1,4-beta-xylanase as its declared activity. The production strain for Econase XT is a genetically modified strain of Trichoderma reesei. No DNA sequences causing concern have been introduced in the production organism. The final enzyme preparations contain no cultivable producer organisms and no antimicrobial activity or mycotoxins in concentrations sufficient to cause concern. The absence of DNA from either the fermentation product or the final formulations was not examined. Since no sequences which cause concern are introduced in the final production strain, the potential presence of low concentrations of recombinant DNA in the final product does not raise any particular safety concern. There is evidence to support the efficacy of Econase XT in improving zootechnical parameters in chickens for fattening at 8000 BXU kg-1, turkeys for fattening at 16000 BXU kg-1 and piglets at 24000 BXU kg-1. This evidence is extended to chickens reared for laying and turkeys reared for breeding at the corresponding dose. Econase XT was shown to be tolerated at 10X (turkeys) or 20X (piglets) the maximum recommended dose (24000 BXU kg-1). It is concluded that Econase XT is safe for these target species at the proposed conditions of use. It is also concluded that the additive is safe for chickens for fattening/reared for laying. However, the results on bone mineralisation raise some doubts on the margin of safety for chickens, which may be lower than the ten-fold tested. Based on the absence of any adverse effect in two mutagenicity/clastogenicity tests and a subchronic oral toxicity study, it can be concluded that Econase XT is of no concern regarding consumer safety when used as an additive in animal feed. Econase XT P/L is non-irritant to the skin, and the liquid form is non-irritant to the eyes and is not a dermal sensitiser. The data suggest no additional precautions beyond those required by the labelling of Econase XT as a respiratory sensitiser. The active component of Econase XT is a protein and as such will be degraded/inactivated during the passage through the digestive tract of animals. Therefore, no risk for the environment is expected and no further environmental risk assessment is required.