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Safety evaluation of certain food additives - ipcs inchem

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PHYTOSTEROLS, PHYTOSTANOLS AND THEIR ESTERS 151<br />

3.5 Summary<br />

The Committee concluded that data currently available support the “directed”<br />

estimate <strong>of</strong> daily exposure to 30 mg/kg bw per day for consumers <strong>of</strong> free<br />

phytosterols and phytostanols in <strong>food</strong>s.<br />

4. COMMENTS<br />

4.1 Toxicological data<br />

The bioavailability <strong>of</strong> phytosterols and phytostanols is lower than that <strong>of</strong><br />

cholesterol. Absorption from the gastrointestinal tract in humans has been<br />

estimated to be about 5% for -sitosterol, 15% for campesterol and less than 1%<br />

for -sitostanol, campestanol and other phytostanols. In a recent human study,<br />

where deuterium-labelled substances were emulsified with lecithin and administered<br />

with the diet, even lower absorption rates (campesterol, 2%; -sitosterol,<br />

campestanol and -sitostanol,

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