NATAMYCIN

Comments:

Based on the available data, JECFA concluded that there is no concern for the induction of antimicrobial resistance and that the risk of natamycin having a disrupting effect on the microbiome of the human gastrointestinal tract is low. JECFA re-affirmed the ADI of 0–0.3 mg/kg bw for natamycin established by the previous Committee at its Twentieth meeting. JECFA further noted that the NOAELs in the new 13-week and 1-year studies in rats (42 and 26 mg/kg bw per day, respectively), with the application of a 100-fold uncertainty factor, support the current ADI of 0–0.3 mg/kg bw.

Meeting:

99

Specs Code:

R

Report: 

Tox Monograph: 

ADI:

0-0.3 mg/kg bw (1976)

Comments:

Natamycin considered for dietary exposure only.

MRL Comment:

In 2006 in a exposure assessment JECFA noted that the data as a whole, including estimations based on GEMS/Food Consumption Cluster Diets and calculations for consumers with a high intake and children, confirm the results of the assessment made by the Committee at its fifty-seventh meeting and show that the current ADI of 0-0.3 mg/kg bw is unlikely to be exceeded.

Meeting:

67

Tox Monograph: 

ADI:

0-0.3 mg/kg bw (1976)

Comments:

JECFA confirmed the previously established ADI of 0-0.3 mg/kg bw.

Meeting:

57

Specs Code:

R

Report: 

Tox Monograph: 

Specification: 

Previous Years: