Safety evaluation of certain food additives - ipcs inchem

148 PHYTOSTEROLS, PHYTOSTANOLS AND THEIR ESTERS
enzyme activity were determined in male and female participants and did not reveal
important biological effects (Ayesh et al., 1999).
3. DIETARY EXPOSURE
3.1 Introduction
The Committee has not previously evaluated the dietary exposure to
phytosterols, phytostanols and their esters. The Committee received and reviewed
information submitted by two sponsors, as well as published information from
the European Food Safety Authority (EFSA) (European Food Safety Authority,
2008) and the USFDA (accessible online at http://www.cfsan.fda.gov/~rdb/
opa-gras.html).
The relative molecular masses of the five major phytosterols and
phytostanols—namely, campesterol and campestanol, -sitosterol and sitostanol,
and stigmasterol—range from 400 to 416 and have not been
differentiated in this monograph owing to the small relative differences among them.
Also, the ratio between the relative molecular masses of the collective free
phytosterols and phytostanols and their esters is taken to be 60% as a default
(3.4 g of esterified phytosterols or phytostanols to metabolically deliver 2 g of free
phytosterols or phytostanols).
3.2 Use in foods
The use of phytosterols, phytostanols and their esters in foods is unusual
with respect to common food additives, in that they do not impart a technical effect
in the food, but rather are intended to lower serum LDL cholesterol in consumers.
The phytosterols, phytostanols and their esters are regulated or allowed for use in
numerous countries, particularly in the European Union (EU), the USA, and
Australia and New Zealand, either as food additives/ingredients or as supplements.
The cholesterol-lowering effects of the phytosterols, phytostanols and their
esters are stated to plateau at approximately 2 g/person per day. Consequently,
food manufacturers have been formulating products containing free phytosterols
and/or phytostanols so as to deliver a convenient “dose”, requiring one, two or three
standard portions a day to reach the 2-g level of intake (or, for the esterified
products, 3.4 g). Rather than a single upper use level, such as “up to 50 mg/kg food”,
the products are individually prepared based on the typical or standard portions sold
in a given jurisdiction. Many product types have been developed, including, but not
limited to, margarines, yogurts and yogurt drinks, cheese products, dairy beverages,
snack (power) bars, candy chews and orange juice. Notices sent to the USFDA
concerning phytosterols, phytostanols and their esters suggested potential uses as
follows: baked goods and baking mixes; egg products; fats and oils; frozen dairy
desserts and mixes; gelatins; ground coffee; grain products and pastas; gravies and
sauces; hard candy; milk; milk products; puddings and pie fillings; soft candy; soups
and soup mixes; and snack foods.