Safety evaluation of xylanase 50316 enzyme preparation (also known as VR007), expressed inPseudomonas fluorescens, intended for use in animal feed


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Abstract

Xylanase 50316 enzyme (also known as VR007) can be added to the diets of monogastric animals to hydrolyze the glycosidic linkages of xylans that are found in these animal feeds. This enzyme was produced from a Pseudomonas fluorescens (P. fluorescens) production strain and was tested in acute, subchronic, and genotoxicity studies. Dosages of the test article preparation ranged from 5000 μg/plate for in vitro toxicity studies to 2000mg/kg/day for in vivo toxicity studies. The highest oral dose tested in vivo (NOAEL of 2000mg/kg/day) resulted in a safety margin of 7226 based on TOS and a conservative estimate of total poultry consumption at the highest inclusion rate. There was no toxicity reported in any of the studies conducted. A review of the public literature indicated that P. fluorescens fulfilled the recognized safety criteria pertinent to microbial production strains used in the manufacture of food/feed enzyme preparations. The results of the toxicity studies presented herein attest to the safety of the xylanase 50316 enzyme for its intended use.HIGHLIGHTSXylanase 50136 enzyme was tested in acute and subchronic studies.Xylanase 50316 enzyme was tested for its potential to induce genotoxicity.There is no evidence of in vitro or in vivo genotoxicity or toxicity.Xylanase 50136 enzyme is safe for use in poultry and swine feed.

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