PECTINS

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.

Meeting:

82

Specs Code:

R

Report: 

Specification: 

ADI:

Not specified

Comments:

The Committee was asked to consider the safety of using non-amidated pectin in infant formula and formula for special medical purposes intended for infants. In a 3-week study in neonatal pigs fed pectin-containing milk replacer, the NOAEL of pectin was 847 mg/kg bw per day, with decreased feed intake and body weight gain observed at 3013 mg/kg bw per day. The Committee concluded that the neonatal pig is an appropriate model for the human infant. Using the NOAEL from this study, the MOEs were estimated to be 0.9 for infants with median energy intake and 0.8 for infants with high (95th percentile) energy intake. The Committee concluded that estimated exposure to pectin from its use in infant formula is in the region of the NOAEL of pectin derived from the neonatal pig study (847 mg/kg bw per day) and close to the LOAEL based on decreased feed intake and body weight gain. Although no overt toxicological effects were observed in the neonatal pigs, decreased food intake and body weight gain would be considered an undesirable effect in human infants. The available clinical studies were mainly conducted with pectin or pectin-derived oligosaccharides at concentrations of 0.2% or less and therefore do not provide support for tolerance and normal growth at the maximum proposed use level. Therefore, the Committee concluded that the use of pectin in infant formulas at the maximum proposed use level (0.5%) is of concern.

Meeting:

79

Specs Code:

M

Report: 

Addendum: 

ADI:

NOT SPECIFIED

Comments:

Group ADI for pectins and amidated pectins, singly or in combination. Non-amidated pectins and their salts as specified are normal constituents of the human diet and have also been administered intravenously at high levels to man without acute toxic effects. The available short-term tests show that even at 5% dietary levels, no adverse effects are seen. The caecal enlargement without any accompanying histological changes is probably related to the presence of large amounts of a polysaccharide in the diet. Amidated pectins produced mild growth depression at a lower level (10%) than was seen with non-amidated pectins in a 90-day test as well as in a two-year study in rats. The available short-term study in rats revealed caecal enlargement but not associated with any histological abnormality. A three-generation reproduction study and a teratogenicity study, and a two-year feeding study in rats fed diets containing 2% and 5% amidated pectin or non-amidated pectin showed no significant toxicological differences between animals fed amidated and non- amidated pectin.

Meeting:

25

Specs Code:

R (1992)

Report: 

Tox Monograph: 

Specification: 

Previous Years: