This meta-analysis was designed to review the published reports regarding the concentration and/or prevalence of aflatoxin M1 (AFM1) in human breast milk in Iran. The carcinogenic risk for Iranian infants consuming this milk was estimated with the hazard index. The PubMed and Scopus databases and the Scientific Information Database were screened for relevant studies between 1995 and 2017, and 11 of the 112 collected studies were included in the systematic review and meta-analysis. The mean (95% confidence interval) concentration of AFM1 was 5.85 ng/L (4.54 to 7.15 ng/L), which was lower than the European Union standard (25 ng/L). The mean prevalence of AFM1 in breast milk in Iran was 42% (11 to 77%). The estimated daily intakes for male and female infants were 0.02 to 5.57 ng/kg and 0.02 to 3.68 ng/kg of body weight per day, respectively. The rank order of estimated daily intake for both male and female infants according to age was 1 week > 1 month > 6 months > 12 months. The hazard index for all age groups of infants in all provinces in Iran was less than 1. Therefore, infants in Iran were not considered at carcinogenic risk from AFM1 in human breast milk.

  • Mean AFM1 in all provinces in Iran was lower than the EC standard limit (25 ng/L).

  • Pooled prevalence of AFM1 in breast milk in Iran was 42% (95% CI, 11 to 77%).

  • Pooled concentration of AFM1 was 5.85 ng/L (95% CI, 4.54 to 7.15 ng/L).

  • Infants consuming breast milk in Iran are not at carcinogenic risk (hazard index < 1).

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