GLUCOSIDASE from ASPERGILLUS NIGER expressed in TRICHODERMA REESEI exhibiting ΑGLUCOSIDASE and TRANSGLUCOSIDASE activity

Comments:

JECFA had no concerns about potential genotoxicity of the enzyme concentrate. The Committee identified a NOAEL of 74.8 mg TOS/kg bw per day, the highest dose tested, for the enzyme concentrate in the 18-week study in rats. Comparison of this NOAEL with the estimated dietary exposure of 0.443 mg TOS/kg bw per day gave an MOE of 169. JECFA therefore established an ADI “not specified” for glucosidase from A. niger expressed in T. reesei exhibiting α-glucosidase (JECFA99-4a) and transglucosidase (JECFA99-4b) activity when used in the applications specified, at the levels of use specified and in accordance with GMP.

Allergenicity:

JECFA concluded that dietary exposure to this glucosidase is not anticipated to pose a risk for allergenicity.

Meeting:

99

Specs Code:

N

Report: 

Tox Monograph: