SAFETY EVALUATION OF AMINO PEPTIDASE ENZYME PREPARATION DERIVED FROM ASPERGILLUS-NIGER

An amino peptidase enzyme preparation obtained from Aspergillus niger was subjected to a series of toxicological tests to document the safel y for use as a processing aid for food. The enzyme preparation was exa mined for subacute and subchronic oral toxicity, and mutagenic potenti al. No evidence of oral toxicity or mutagenicity was found. Administra tion of the amino peptidase enzyme preparation at doses of 500, 1000 a nd 2000 mg/kg body weight/day for 90 days did not induce noticeable si gns of toxicity. The no-observed-adverse-effect level (NOAEL) of the e nzyme preparation in the subchronic toxicity study was 2000 mg/kg body weight/day (equivalent to 1152 PHEA units/kg body weight/day). II can be concluded that no safety concerns were identified in the studies c onducted with this amino peptidase enzyme preparation derived from Asp ergillus niger and produced under controlled fermentation conditions. (C) 1998 Elsevier Science Ltd. All rights reserved.