Safety evaluation of a lipase enzyme (BD29241 Palmitase) preparation, expressed in Pseudomonas fluorescens, intended for removing palmitic acid from triacylglycerol

► BD29241 Palmitase was tested in acute, inhalation, and subchronic toxicity studies. ► BD29241 Palmitase was also tested for its potential to induce genotoxicity. ► There was no evidence of in vitro genotoxicity or in vivo toxicity. ► BD29241 Palmitase is safe for producing oils and fats low in palmitic acid. The lipase enzyme, BD29241 Palmitase, can be used as a processing aid for removing palmitic acid from triacylglycerol in the production of refined oil. This enzyme was produced from a Pseudomonas fluorescens (P. fluorescens) production strain and was tested in acute, inhalation, and subchronic toxicity studies. In addition, this enzyme was also tested for its potential to induce genotoxicity. Dosages of the test article preparation ranged from 5000μg/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 2.442×103 based on a conservative estimate of the total human consumption of BD29241 Palmitase of 0.819mg/kg/day. There was no toxicity reported for any of these studies including additional safety studies. A review of the literature indicates that P. fluorescens fulfills recognized safety criteria pertinent to microbial production strains used in the manufacture of food enzyme preparations. The results of the toxicity studies presented herein attest to the safety of BD29241 Palmitase for its above-stated intended use.