Scientific Opinion on the safety and efficacy of Roxazyme® G2 G/L (endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and endo-1,(3)4-beta-glucanase) as a feed additive for poultry and piglets

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the additive Roxazyme® G2 when used as a zootechnical additive in poultry and piglets (weaned). The additive Roxazyme® G2 is a preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and endo-1,(3)4-beta-glucanase produced by a strain of Trichoderma reesei. The FEEDAP Panel concludes that the additive is safe for poultry species and for piglets at the maximum proposed dose. The results of two in vitro genotoxicity studies and a sub-chronic oral toxicity study did not indicate any concern for consumer safety arising from the use of the product as a feed additive. The enzymes contained in Roxazyme® G2 are non-irritant to the eyes and skin and are not dermal sensitisers. The additive should be considered as a potential respiratory sensitiser. The active substances of Roxazyme® G2 are proteins, and as such will be degraded/inactivated during the passage through the digestive tract of animals. Therefore, no further environmental risk assessment is required. The FEEDAP Panel concludes that Roxazyme® G2, in either form, has the potential to be efficacious in the target species. The nominal dosages showing efficacy were 50 mg additive/kg feed in chickens for fattening and ducks, 80 mg additive/kg feed in laying hens and 100 mg additive/kg feed in turkeys for fattening and piglets. The conclusions are extended to chickens reared for laying and turkeys reared for breeding at the corresponding dose and can be extrapolated to include all minor poultry species (dose of 50 mg/kg for growing birds and of 80 mg/kg for laying birds). However, based on the incomplete information provided by the applicant the FEEDAP Panel is not in a position to specify the minimum enzyme activities (three enzymes) that are efficacious.