Safety evaluation of certain food additives - ipcs inchem

PHYTOSTEROLS, PHYTOSTANOLS AND THEIR ESTERS 119
responded to several Generally Recognized as Safe (GRAS) Notices concerning
specified uses of phytosterols and phytostanols in various types of food (http://
vm.cfsan.fda.gov/~rdb/opa-gras.html#grastop).
This report describes the data on phytosterols, phytostanols and their esters
discussed at the present meeting, with the focus on newly submitted data and other
new information published since the evaluations by other regulatory bodies.
The Committee noted that phytosterols, phytostanols and their esters do not
fall into the definition of a food additive as defined by the Codex Alimentarius
Commission (2007b), 1 because they do not fulfil a technological purpose in food or
food processing. At its present meeting, the Committee evaluated the safety of these
mixtures, when present in food. It is stressed that the effectiveness of these
substances in reducing blood concentrations of cholesterol was not assessed by
the Committee.
1.1 Chemical and technical considerations
Phytosterols, phytostanols and their esters are structurally related to
cholesterol, but differ in the structure of the side-chain (Figure 1). Phytosterols have
an unsaturated bond between positions 5 and 6 on the B-ring of the steroidal
skeleton, whereas this bond is saturated in phytostanols. The more common
phytosterols, -sitosterol and campesterol, are found to varying degrees in soya
bean oil and tall oil arising from wood pulping. Minor components, among them
stigmasterol and brassicasterol, are also present in other vegetable oils. The major
phytostanols are -sitostanol and campestanol. Phytosterols and phytostanols are
extracted from plant materials as the free form and as their fatty acid esters. There
are numerous commercial products, both raw materials and finished products,
containing phytosterols, phytostanols and their esters in different proportions.
1 “Food additive means any substance not normally consumed as a food by itself and not
normally used as a typical ingredient of the food, whether or not it has nutritive value, the
intentional addition of which to food for a technological (including organoleptic) purpose in
the manufacture, processing, preparation, treatment, packing, packaging, transport or
holding of such food results, or may be reasonably expected to result, (directly or indirectly)
in it or its by-products becoming a component of or otherwise affecting the characteristics
of such foods. The term does not include ‘contaminants’ or substances added to food for
maintaining or improving nutritional qualities.”