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.