Bacillus licheniformis-Protease Enzyme Evaluated by EFSA

Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of the feed additive Cibenza® EP150



Cibenza® EP150 contains a protease produced by fermentation of a single strain of Bacillus licheniformis. The final preparation contains the specified enzyme, spores of the production organism (both of which are declared constituents) and spent medium. It is prepared in dry form and is intended for use as a zootechnical feed additive (functional group 'other zootechnical additives') for chickens for fattening, chickens reared for laying and all relevant minor avian species in the growing or fattening phases (but excluding laying birds) and ornamental birds.



On the basis of a tolerance trial made with chickens for fattening, birds appeared to tolerate the additive at ten-times the recommended dose and consequently the additive is considered safe at the recommended dose of 500 mg/kg complete feedingstuffs. This conclusion also applies to chickens reared for laying and can be extrapolated to other avian species used for meat production and ornamental birds when the same dose is applied.



Use of the additive in feed for chickens for fattening, chickens reared for laying and other avian species used for meat production is considered safe for consumers.



The additive is not a skin irritant but is an eye irritant. Because of the observed severe irritation in the eye and the known capacity of enzyme products to induce sensitisation, the additive has the potential to be a skin sensitiser and to induce sensitisation following respiratory exposure.



The organism, which is a strain of a naturally-occurring soil bacterial species, and its fermentation products are considered not to present a hazard for the environment.



A significant production benefit of the addition of the additive using the recommended dose (500 mg/kg complete feedingstuffs) was seen in chickens for fattening but only when a reduced protein diet was provided. No significant effects were seen when a standard poultry diet was fed. This conclusion on efficacy is taken to apply to chickens reared for laying and can be extrapolated to other avian species used for meat production and ornamental birds when the same dose is used.



Use of the additive is compatible with the following coccidiostats: diclazuril, nicarbazin, decoquinate, semduramycin, lasalocid sodium, monensin sodium, robenidine hydrochloride, maduramicin ammonium, narasin and salinomycin.