Safety and efficacy of Bergazym® P100 (endo-1,4-β-xylanase) as a feed additive for chickens for fattening, weaned piglets and pigs for fattening.

Abstract

Bergazym® P is a preparation of endo‐1,4‐β‐xylanase (xylanase) that is intended to be used as a zootechnical additive in feed for chickens for fattening, weaned piglets and pigs for fattening at a dose of 1,500 EPU/kg feed. The xylanase is produced by a non‐genetically modified strain of Trichoderma reesei. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded from the tolerance studies submitted that the additive is safe for chickens for fattening and weaned piglets at 1,500 EPU/kg feed. The conclusions were extended to pigs for fattening. The results obtained with the enzyme concentrate used to formulate the additive in the genotoxicity studies and in the sub‐chronic oral toxicity study do not indicate any reason for concern for consumer safety arising from the use of the product as feed additive. From the data provided on the enzyme concentrate used to formulate the additive, the Panel concluded that the additive is not irritant to skin or eyes but it is considered a potential skin sensitiser. Owing to the proteinaceous nature of the active substance, the additive is considered a potential respiratory sensitiser. The FEEDAP Panel concluded that no risks to the environment are expected. To support the efficacy of the additive, the applicant submitted five trials in chickens for fattening, five in weaned piglets and three in pigs for fattening. The FEEDAP Panel could not conclude on the efficacy of the additive in chickens for fattening and weaned piglets, but concluded that the additive has the potential to be efficacious in pigs for fattening at the recommended dose.