Safety evaluation of certain food additives - ipcs inchem

118 PHYTOSTEROLS, PHYTOSTANOLS AND THEIR ESTERS
Reproductive toxicity .....................................................
Rats ........................................................................
Special studies on estrogenic activity ...........................
Observations in humans .....................................................
Lipid-lowering effect.......................................................
Effects on vitamins and carotenoids .............................
Association with atherosclerosis....................................
Other effects..................................................................
Dietary exposure .......................................................................
Introduction..........................................................................
Use in foods.........................................................................
International estimates of dietary exposure.........................
National estimates of dietary exposure ...............................
Background exposure from food....................................
“Directed” exposure from food ......................................
Potential overconsumption of phytosterols/
phytostanols..............................................................
Summary .............................................................................
Comments .................................................................................
Toxicological data ...............................................................
Short-term studies of toxicity with phytosterol ester
mixtures ....................................................................
Short-term studies of toxicity with mixtures of
phytosterols and phytostanols...................................
Short-term studies of toxicity with phytostanol ester
mixtures ....................................................................
Studies of reproductive toxicity with phytosterol ester
mixtures ....................................................................
Studies of reproductive toxicity with phytostanol ester
mixtures ....................................................................
Genotoxicity...................................................................
Estrogenicity..................................................................
Human studies.....................................................................
Assessment of dietary exposure .........................................
Evaluation ..................................................................................
References ................................................................................
1. EXPLANATION
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Phytosterols, phytostanols and their esters were evaluated by the Committee
at its present meeting at the request of the Codex Committee on Food
Additives at its Thirty-ninth Session (Codex Alimentarius Commission, 2007a).
Phytosterols and phytostanols are substances that are similar in structure to
cholesterol and are formed exclusively in plants. They are added to food for their
blood cholesterol–lowering properties.
Phytosterols, phytostanols and their esters have not been evaluated
previously by the Committee. In 2000 (Scientific Committee on Food, 2000) and
again in 2002 (Scientific Committee on Food, 2002), the former Scientific
Committee on Food (SCF) of the European Commission assessed the safety of
phytosterols in food. The United States Food and Drug Administration (USFDA)
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