Safety evaluation of certain food additives - ipcs inchem

PHYTOSTEROLS, PHYTOSTANOLS AND THEIR ESTERS 155
diets with phytostanol esters, were not observed in humans, at least at dose levels
applied in the human studies (1–3 g/day).
Available data show that diets containing added phytosterols, phytostanols
or their esters in doses up to 2 g/day (as phytosterols/phytostanols) lead to (up to)
2-fold increases in plasma concentrations. Various epidemiological studies
investigated a possible correlation between phytosterol plasma levels and
indicators for atherosclerosis and an increased risk for CHD. Taken together, to date
there is no convincing evidence for an association of elevated phytosterol levels and
increased risk for CHD.
4.3 Assessment of dietary exposure
The Committee received and reviewed information on dietary exposure
submitted by two sponsors, as well as published information from EFSA and the
USFDA. 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
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 was 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).
Phytosterols, phytostanols and their esters are regulated or allowed for use
in numerous countries, particularly in the EU, the USA, Australia and New Zealand,
either as food additives/ingredients or as supplements. The cholesterol-lowering
effects of free phytosterols and phytostanols are stated to reach a 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. Other potential uses include 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.
The natural background intake of free phytosterols and phytostanols from
numerous plant products, including seeds, nuts and vegetable oils, has been
estimated to be in the range of 150–400 mg/day, with the phytosterols representing
approximately 90% of the total. As discussed above, consumers of foods containing
phytosterols, phytostanols or their esters are directed to consume them in one, two
or three portions a day in order to achieve a dose of 2 g free phytosterols or
phytostanols per day (30 mg/kg bw per day for a 60-kg individual). The Committee
was aware that products containing phytosterols, phytostanols or their esters are