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Safety and efficacy of ROVABIO® SPIKY (endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase) as a feed additive for all major and minor poultry species

ROVABIO® SPIKY is a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase that is authorised as a feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species for fattening and reared for laying. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) issued two opinions on this additive. Safety aspects regarding the use of this additive in feed have been previously established. The Panel concluded that the additive is safe for the consumers and the environment and that the additive is not irritant to the skin or eyes but should be considered a potential skin sensitiser and potentially harmful if inhaled. The Panel considered that these conclusions are still valid for the current application. The current application covered the use of the additive in all poultry species at the dose of 1,100 U xylanase and 760 U glucanase per kg feed. In previous assessments, the Panel concluded that the additive is safe and efficacious under the proposed conditions of use in chickens and turkeys for fattening or raised for laying/breeding and to minor poultry species for fattening or raised for laying/breeding. In order to support the safety for laying animals, the applicant provided a tolerance trial in laying hens from which the Panel concluded that the additive is safe for laying hens at the recommended dose. The safety established in laying hens is considered to apply also to breeding hens and can be extrapolated to minor poultry species for laying. Regarding the efficacy the additive increased the metabolisable energy content of the diets in one trial and the performance of the laying hens in two trials at the recommended dose. Therefore, the FEEDAP Panel concluded that the additive has the potential to be efficacious in laying hens. This conclusion applies also to breeding hens and can be extrapolated to include all minor poultry species for laying.

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