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Twenty-seven samples of infant formulae and follow-on formulae and fifteen samples of baby food from Iranian markets were analyzed for concentrations of four polycyclic aromatic hydrocarbons (PAH4) determined by use of gas chromatography coupled to mass spectrophotometry. An assessment of risks posed to infants and toddlers was conducted by calculating the margin of exposure and incremental lifetime cancer risk (ILCR) by use of the Monte Carlo Simulation Method. Benzo (a) anthracene, was not detected in any of the samples, while approximately 64.3% samples contained detectable amounts of benzo (a) pyrene, while chrysene was observed in three samples and benzo (b) fluoranthene was detected in one sample. One of the samples contained 1.43 μg PAH4/kg, which was greater than the maximum tolerable limit (MTL; 1 μg/kg) stated in Commission Regulation (EU) 2015/1125. Accordingly, the 95% ILCRs in the infants/toddlers due to ingestion of milk powder and baby foods were determined to be 1.3 × 10−6 and 7.3 × 10−7, respectively. Also, the 95th centiles of the MOEs, due to ingesting milk powder or baby foods by infants/toddlers were estimated to be 3.6 × 104 and 7.2 × 104, respectively. In Iran, infants and toddlers are not at serious health risk (MOE ≥ 1 × 104 and ILCR < 1 × 10−4). Image 1 • Four polycyclic aromatic hydrocarbons (PAH4) determined in infant formulae, follow-on formulae and baby foods. • An assessment of risks posed to infants and toddlers was conducted by use of the Monte Carlo Simulation (MCS) method. • One of the samples contained 1.43 μg PAH4/kg, which was greater than the maximum tolerable limit (MTL; 1 μg/kg). • In Iran, infants and toddlers are not at serious health risk (MOE ≥ 1 × 104 and ILCR < 1 × 10−4). [ABSTRACT FROM AUTHOR]