| Comments: | The No-Observed-Adverse-Effect level (NOAEL) in a previously evaluated neonatal pig study was recalculated to be 1049 mg/kg bw per day using measured concentrations of pectin in milk replacer rather than target concentrations.
At the new maximum proposed use level of 0.2%, the estimated exposure of infants 0–12 weeks of age would be up to 360 and 440 mg/kg bw per day at mean and high consumption. The margins of exposure for average and high consumers are 2.9 and 2.4, respectively, when compared with the NOAEL of 1049 mg/kg bw per day.
On the basis of a number of considerations, the Committee concluded that the margins of exposure calculated for the use of pectin at 0.2% in infant formula indicate low risk for the health of infants and are not of concern. |