Safety evaluation of lipase fromMucor mieheifor inter‐esterification of edible oils and fats

A new lipase for modification of edible oils and fats was subjected to toxicological investigations. Fermentation of the lipase is based on the micro‐organism Mucor miehei a high yielding strain selected for this purpose. The micro‐organism was evaluated for pathogenicity and was classified as a weak pathogen to mice, with no evidence of pathogenic potential in healthy persons. The toxicological studies on the enzyme included subchronic 13 week feeding studies in rats and dogs, teratogenicity and two generation reproduction studies in rats, and mutagenicity studies using bacteria and rats. The no effect levels from subchronic toxicity studies were approximately 1 g/kg body weight/day for rats and 4 g/kg body weight/day for dogs. There was no evidence of teratogenic or mutagenic potential and no effect on fertility and general reproductive performance. It was concluded that this lipase is suitable for the production of oils and fats for human consumption.