AMYLOGLUCOSIDASE (JECFA95-4) from RASAMSONIA EMERSONII expressed in ASPERGILLUS NIGER

Comments:

JECFA concluded that dietary exposure to this enzyme is not anticipated to pose a risk for allergenicity.   Based on the absence of any treatment-related adverse effects in a 13-week oral toxicity study in rats, the previous JECFA identified a NOAEL of 1500 mg TOS/kg bw per day, the highest dose tested. The previous JECFA concluded that the dietary exposure estimate of 9 mg TOS/kg bw per day was appropriate for use in the evaluation. Comparison of the NOAEL of 1500 mg/kg bw per day with the dietary exposure estimate of 9 mg TOS/kg bw per day yields an MOE of more than 160.

Meeting:

100

Specs Code:

R

Report: 

Tox Monograph: 

Specification: 

ADI:

NOT SPECIFIED (TEMPORARY)

Comments:

JECFA established a temporary ADI “not specified” for amyloglucosidase (JECFA95-4) from R. emersonii expressed in A. niger when used in the applications specified, at the levels of use specified and in accordance with current GMP. The ADI “not specified” was made temporary because of the tentative nature of the specifications and the inability to complete the allergenicity assessment.

Meeting:

95

Specs Code:

N; T

Report: 

Tox Monograph: 

Specification: