Safety and efficacy of FRA® Octazyme C Dry(endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening
The product FRA® Octazyme C Dry contains eight enzymes and is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. In a previous opinion of the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the additive was characterised in full, including the production strains of the enzymes, the safety and the efficacy of the product. In that assessment, the FEEDAP Panel concluded that the additive was safe for the consumers of food products obtained from animals fed with the additive and that the additive would pose no risks to the environment. Regarding the safety for the users, the Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties, but the additive should be considered a potential respiratory sensitiser. In the trials submitted to support the safety for the target species and the efficacy of the additive, the analytical results of the enzyme activities did not confirm the intended enzyme activities and therefore the FEEDAP Panel could not draw conclusions on the tolerance and the efficacy of the additive. In the current application, the applicant has provided new analysis of the feeds used in the tolerance and efficacy trials. The data have been obtained using a modified extraction procedure which has demonstrated to permit a higher recovery of the enzyme activity in supplemented and non‐supplemented feeds. However, the enzyme activities obtained in the experimental diets using the new analytical method showed increases but also decreases of the enzyme activity compared to the previously submitted data. Therefore, the change in the enzyme activities could not be ascribed to the analytical method only. The Panel concluded that the new data cannot be considered as those reflecting the actual supplementation levels of the additive in the diets and therefore could not conclude on the safety and efficacy of the target species.