SAFETY EVALUATION OF ESPERASE

Esperase is a proteolytic enzyme preparation that can be used as a pro cessing aid in the food industry. The following studies were performed to establish safety for the consumer: oral toxicity study (13 wk) in the rat; teratogenicity study in the rat; gene mutation assays in Salm onella typhimurium and mammalian cells in vitro, and chromosome aberra tion assay in vitro. General toxicity was low; the effects seen were a ttributed to proteolytic activity and the loading with sodium chloride . Neither of these factors will be relevant to consumers of the proces sed food. There was no evidence of effects on pregnancy outcome or mut agenic potential. When these results are considered together with exis ting knowledge of the production organism and the chemical and microbi ological characterization of the enzyme preparation, they indicate tha t Esperase will be safe for its intended application in food processin g.