LOCUST BEAN GUM

Comments:

Only considered whether its safe for use in infant formulas.

Intake:

JECFA previously assigned an ADI “not specified” to carob bean gum. However, an ADI does not apply to infants younger than 12 weeks since they might be at risk at lower levels of exposure compared with older age groups. Newly submitted unpublished data obtained from a neonatal pig study evaluated at the present meeting allowed JECFA to identify a NOAEL of 2400 mg/kg bw per day, the highest dose tested. Based on the estimated high dietary exposures for infants, JECFA noted that MOEs calculated for the use of carob bean gum at 1000 mg/L and 6000 mg/L in infant formula were 9 and 1.5, respectively. The MOE for the high exposure calculated for infants from the use of carob bean gum at 10 000 mg/L in infant formula was less than 1. JECFA concluded that the MOEs based on carob bean gum concentrations of 1000 and 6000 mg/L in infant formula indicate a low risk; however, the MOE based on a concentration of 10 000 mg/L indicates a potential risk. Based on the available data and considering the short exposure period involved, JECFA concluded that there is no concern for the disruption of the intestinal microbiota by carob bean gum used as a thickener in infant formula.

Meeting:

100

Report: 

Tox Monograph: 

Specification: 

ADI:

NOT SPECIFIED

Comments:

JECFA concluded that the available studies are not sufficient for the evaluation of carob bean gum for use in infant formula at the proposed use level. JECFA requests toxicological data from studies in neonatal animals, adequate to evaluate the safety for use in infant formula, to complete the evaluation.

Meeting:

82

Specs Code:

R

Report: 

Tox Monograph: 

Specification: 

ADI:

NOT SPECIFIED

Meeting:

25

Specs Code:

R (1995)

Report: 

Tox Monograph: 

Specification: 

Previous Years: