Safety and efficacy of Natugrain® TS (endo-1,4-ß-xylanase and endo-1,4-ß-glucanase) as a feed additive for piglets (weaned), chickens for fattening, laying hens, turkeys for fattening and ducks

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 deliver a scientific opinion on the safety and efficacy of Natugrain® TS (endo-1,4-ß-xylanase and endo-1,4-ß-glucanase) as a feed additive within the category of for fattening, laying hens and piglets. The additive Natugrain® TS is produced in two formulations, i.e. Natugrain® TS L (liquid) and Natugrain® TS (solid). Both formulations contain thermostable endo-1,4-β−xylanase and thermostable endo-1,4-β-glucanase, both enzymes being produced by genetically modified strains of Aspergillus niger. The enzyme mixture contains no cultivable production organisms and the level of recombinant DNA is below the limit of detection. The efficacy of Natugrain® TS and Natugrain® TS L has been demonstrated at the minimum dose proposed in chickens for fattening (50 mg kg-1), laying hens (100 mg kg-1), turkeys for fattening (100 mg kg-1) and piglets (100 mg kg-1). Efficacy in ducks for fattening (50 mg kg-1) can be extrapolated based on the efficacy for chickens and turkeys for fattening. Based on the tolerance studies provided by the applicant, Natugrain® TS and Natugrain® TS L are considered to be safe for the target species at the respective maximum proposed doses. Considering the lack of mutagenicity in two assays and the absence of any relevant effects in a 90-day study, it is concluded that the use of Natugrain® TS as an additive in animal feed would pose no risk for the consumer. The solid form of the product is non-irritant for the eye and skin. It is presumed to be a potential skin and respiratory sensitiser. Although no study is provided on dermal sensitisation or on the effects of inhalation exposure, any precaution appropriate to protecting the user from the respiratory sensitising properties would be sufficient to protect against any other adverse effects. The active ingredients of Natugrain® TS are proteins and as such will be degraded/inactivated during the passage through the digestive tract of animals. Therefore, no risk for the environment is envisaged.