TRIBASIC SODIUM PHOSPHATE

Comments:

JECFA concluded that a group MTDI for phosphoric acid and phosphate salts, based on the end-point of nephrocalcinosis and nephropathy in rats, remained appropriate. JECFA considered the CSAF approach taken by EFSA to be appropriate to refine the uncertainty factor to be used for establishing an MTDI. Applying the CSAF of 4 for interspecies and intraspecies variation, together with an additional uncertainty factor of 3 for use of a LOAEL instead of a NOAEL (total factor of 12) to the LOAEL of 910 mg/kg bw per day, resulted in an MTDI value of 76 mg/kg bw per day. This assessment supports maintaining the current MTDI of 70 mg/kg bw per day. This value is also supported by the UL for adults for phosphorus intake established by NHMRC/MOH, Health Canada and NIH of 4000 mg/day, equal to 67 mg/kg bw per day based on a 60 kg body weight. JECFA also noted that the MTDI is consistent with DRVs for phosphorus intake by infants. At the lower end of the body weight range for infants aged 0–6 and 7–12 months, the DRV of 100 and 275 mg/day equates to 50 and 55 mg/kg bw per day, respectively, lower than the MTDI. JECFA therefore concluded that the MTDI of 70 mg/kg bw established by the previous JECFA should be retained.

Intake:

Dietary exposure to phosphorus from phosphates for infants younger than 12 weeks ranged over 27–117 mg/kg bw per day. JECFA noted that phosphorus is an essential nutrient for infant development, and total phosphorus levels in infant formula, including from additive use, should be within the minimum and guidance upper levels (170 and 670 mg/L, respectively). Based on this consideration, JECFA concluded that the estimated dietary exposures for infants younger than 12 weeks are not a safety concern.

Tolerable Intake:

MTDI 70 mg/kg bw (as P)

Meeting:

102

Specs Code:

No

Comments:

Group MTDI for phosphorus from all sources, expressed as P

Tolerable Intake:

MTDI 70 mg/kg bw (as P)

Meeting:

26

Specs Code:

R (1975)

Report: 

Tox Monograph: 

Specification: 

Previous Years: