Scientific Opinion on the safety and efficacy of Finase® EC (6-phytase) as a feed additive for chickens for fattening and reared for laying, laying hens, turkeys for fattening and reared for breeding, ducks and other minor poultry species, piglets (weaned), pigs for fattening and sows

zootechnical additive, 6-phytase, genetically modified microorganism, Trichoderma reesei, poultry, pigs, safety, efficacy
First published in the EFSA Journal
30 novembre 2009
Adopted
11 novembre 2009
Type
Scientific Opinion

Abstract

Finase® EC is a preparation of 6-phytase produced by a genetically modified fungus Trichoderma reesei. The additive is intended to be used at a dose range of 250–1000 PPU/kg complete feed for pigs (all categories), chickens for fattening or reared for laying and turkeys for fattening or reared for breeding and at a minimum dose of 125–1000 PPU/kg complete feed in laying hens, ducks and other minor poultry species. The final enzyme preparations contain no cultivable production organisms or recombinant DNA above the limits of detection. The products do not have antimicrobial activity or mycotoxins. Based on the results of the tolerance studies Finase® EC is safe at 1000 PPU/kg feed for chickens for fattening, laying hens, which can be extrapolated to all minor poultry species, and for piglets and pigs for fattening. A conclusion on the tolerance for the turkeys for fattening and for sows was not possible. Based on the absence of compound related adverse effects on two mutagenicity/clastogenicity tests and absence of any relevant effects in a subchronic oral toxicity study it is concluded that the use of Finase® EC as feed additive is of no concern regarding consumer safety. Finase® EC is not irritant to skin or eye and is not a skin sensitizer, but it is considered to be a respiratory sensitizer. No risk for the environment is expected. Finase® EC is efficacious in pigs (all categories), chickens for fattening and chickens reared for laying, and in turkeys for fattening and turkeys reared for breeding at 250 PPU/kg, and in laying hens at 125 PPU/kg. The conclusions on the data provided for major poultry species can be extrapolated to all minor poultry species.

Panel on Additives and Products or Substances used in Animal Feed
Panel on Genetically Modified Organisms
Contact
FEEDAP [at] efsa.europa.eu
doi
10.2903/j.efsa.2009.1380
EFSA Journal 2009;7(11):1380
Question Number
On request from
European Commission