NISIN

Comments:

JECFA established an ADI for nisin of 0–2 mg/kg bw on the basis of a NOAEL of 224.7 mg of nisin per kilogram body weight per day from a 13-week study in rats and application of a safety factor of 100 to account for interspecies and intraspecies variability. JECFA did not consider it necessary to use an additional safety factor to account for the short duration of the study because no compound-related effects were observed at any dose in any of the toxicity studies, including the reproductive toxicity study, and because ingested nisin is degraded in the upper part of the intestinal tract, such that systemic exposure to nisin is not likely to occur. The highest estimated dietary exposure of 0.07 mg of nisin per kilogram body weight per day determined at the current meeting did not exceed the upper bound of the ADI. JECFA withdrew the previous ADI of 0–33 000 units of nisin per kilogram body weight established at the twelfth meeting.

Specs Code:

R

Report: 

Tox Monograph: 

Specification: 

ADI:

0-33000 units/kg bw

Comments:

Unconditional ADI given in units/kg of body weight

Meeting:

12

Specs Code:

N

Report: 

Tox Monograph: 

Specification: 

Previous Years: