PHYTOSTEROLS, PHYTOSTANOLS and THEIR ESTERS

Overview

Chemical Names
Sitosterol: (3)-Stigmast-5-en-3-ol Sitostanol: (3,5)-Stigmastan-3-ol Campesterol: (3)-Ergost-5-en-3-ol Campestanol: (3,5)-Ergostan-3-ol Stigmasterol: (3)-Stigmasta-5,22-dien-3-ol Brassicasterol: (3)-Ergosta-5,22-dien-3-ol Esters of sitostano
Synonyms
Plant sterols/stanols, Plant sterol/stanol esters, Phytosterol/Phytostanol esters
Functional Class
Food Additives
FOOD_ADDITIVE

Evaluations

Evaluation year: 2008

ADI:
0–40 mg/kg bw

Comments:
Group ADI of 0-40 mg/kg bw for phytosterols, phytostanols and their esters, expressed as the sum of phytosterols and phytostanols in their free form, based on an overall NOAEL of 4200 mg/kg bw per day to which a safety factor of 100 was applied. The overall NOAEL was identified using the combined evidence from several short-term (90-day) studies of toxicity. The Committee considered the margin between this overall NOAEL and the lowest LOAEL from the 90-day toxicity studies of 9000 mg/kg bw per day as adequate for this overall NOAEL to be used as the basis for establishing an ADI. This conclusion is supported by the results of the available studies of reproductive toxicity. Based on available data, the Committee concluded that dietary exposure to phytosterols and phytostanols would typically be within the ADI range.
Report: 
TRS 952-JECFA 69/39
Tox Monograph: 
FAS 60-JECFA 69/
Specification: 
FAO Combined Compendium of Food Additive Specifications