NISIN A

Comments:

Based on the available data, JECFA concluded that there is no concern for the induction of antimicrobial resistance, and that the risk of nisin having a disrupting effect on the microbiome of the human gastrointestinal tract is low. The new toxicological information available for this evaluation did not provide any reason to revise the ADI for nisin. JECFA re-affirmed the ADI of 0– 2 mg/kg bw for nisin established by the previous JECFA meeting at the Seventy-seventh meeting, but noted that the critical toxicological studies were conducted with nisin A; JECFA therefore concluded that the ADI applies only to nisin A.

Meeting:

99

Specs Code:

R

Report: 

Tox Monograph: 

ADI:

0–2 mg/kg bw

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: