ASCORBYL STEARATE

Comments:

JECFA noted new studies that showed that ascorbyl palmitate was rapidly and extensively hydrolysed pre-systemically to ascorbic acid and palmitic acid. Hydrolysis of ascorbyl palmitate is mediated by carboxylesterases, which are also expressed in neonates and infants, albeit at lower levels than in adults. On that basis, JECFA considered that systemic exposure to ascorbyl palmitate would be low for all population subgroups. JECFA withdrew the previously established ADI of 0–1.25 mg/kg bw for ascorbyl palmitate or ascorbyl stearate, or the sum of both. JECFA noted that the previous ADI for ascorbyl palmitate or ascorbyl stearate, or the sum of both, was based on toxicological data for ascorbyl palmitate, and therefore established a group ADI “not specified”b for ascorbyl palmitate or ascorbyl stearate, or the sum of both.

Meeting:

100

Specs Code:

R

Report: 

Specification: 

ADI:

0-1.25 mg/kg bw

Comments:

As ascorbyl palmitate or ascorbyl stearate, or the sum of both

Meeting:

17

Specs Code:

R

Report: 

Tox Monograph: 

Specification: 

Previous Years: