Safety and efficacy of Natugrain® TS (endo-1,4-β-xylanase and endo-1,4-β-glucanase) for chickens for fattening
The additive is a preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase produced by two genetically modified strains of Aspergillus niger. It is authorised for use in piglets (weaned) and pigs for fattening, poultry species and ornamental birds as a zootechnical additive, functional group of digestibility enhancers. The applicant is now seeking for the authorisation of the product as a feed additive for chickens for fattening under the functional group of other zootechnical additives in order to positively affect the welfare of the animals. Aspects other than the efficacy of the product under the new functional group have been addressed in previous opinions and the new proposed use would not change the previous conclusions. The dossier submitted also presented new data regarding the safety for the user. Therefore, the Panel assessed the data on the safety for the user and the data supporting the efficacy of the additive under the new functional group. The Panel concluded that the additive is a dermal sensitiser. Two efficacy trials were considered in the assessment; the addition of Natugrain® TS at the recommended dose in the diets reduced the lesions on the foot-pad and on the hock of chickens for fattening on day 42 of life in the two trials. However, considering the limitations of the studies regarding the type of diets used and the fact that three studies are required to demonstrate the efficacy of the additive, the Panel could not conclude on the efficacy of Natugrain® TS in chickens for fattening as a zootechnical additive, functional group of other zootechnical additives.