Evaluations of the Joint FAO/WHO Expert Committee on Food Additives (JECFA)
3-MONOCHLORO-1,2-PROPANEDIOL (3-MCPD) ESTERS
Experimental evidence indicates that 3-MCPD esters are substantially hydrolysed to 3-MCPD in the gastrointestinal tract and elicit toxicity as free 3-MCPD. The Committee therefore based its evaluation on the conservative assumption of complete hydrolysis of 3-MCPD esters to 3-MCPD. No genotoxic potential has been demonstrated in vivo for 3-MCPD. Two long-term carcinogenicity studies with 3-MCPD in rats were identified as pivotal studies, and renal tubular hyperplasia was identified as the most sensitive end-point. The lowest BMDL10 for renal tubular hyperplasia was calculated to be 0.87 mg/kg bw per day for male rats. After application of a 200-fold uncertainty factor, the Committee established a group PMTDI of 4 µg/kg bw for 3-MCPD and 3-MCPD esters singly or in combination (expressed as 3-MCPD equivalents). The overall uncertainty factor of 200 incorporates a factor of 2 related to the inadequacies in the studies of reproductive toxicity. The previous PMTDI of 2 µg/kg bw for 3-MCPD, was withdrawn. The Committee noted that estimated dietary exposures to 3-MCPD for the general population, even for high consumers (up to 3.8 µg/kg bw per day), did not exceed the new PMTDI. Estimates of mean dietary exposure to 3-MCPD for formula-fed infants, however, could exceed the PMTDI by up to 2.5-fold for certain countries (e.g. 10 µg/kg bw per day in the first month of life).
PMTDI of 4 µg/kg bw for 3-MCPD and 3-MCPD esters singly or in combination
TRS 1002- JECFA 83/104
FAS 74-JECFA 83