Safety evaluation of certain food additives - ipcs inchem

PHYTOSTEROLS, PHYTOSTANOLS AND THEIR ESTERS 149
3.3 International estimates of dietary exposure
In light of a number of published studies on the dietary exposure of
phytosterols, phytostanols and their esters (summarized in European Food Safety
Authority, 2008), information concerning dietary exposure contained in letters
responding to GRAS notifications in the USA (accessible at the USFDA/Center
for Food Safety and Applied Nutrition [CFSAN] web site), and their specific use for
the reduction of cholesterol in targeted subpopulations, the Committee chose not
to prepare international estimates of dietary exposure to the phytosterols,
phytostanols and their esters.
3.4 National estimates of dietary exposure
3.4.1 Background exposure from food
The natural background exposure to phytosterols, phytostanols and their
esters from foods has been studied. They are found in numerous plant products,
including seeds, nuts and vegetable oils. Both free and esterified forms are
found. It has been estimated that the daily supply of phytosterols, phytostanols
and their esters is in the range of 150–400 mg (Scientific Committee on Food,
2002). This range is in keeping with more recent estimates of dietary exposure
to phytosterols and phytostanols in Finland (305 and 237 mg/day for men and
women, respectively), Spain (276 mg/day for the four main phytosterols) and
the United Kingdom (300 and 293 mg/day for men and women, respectively) (Valsta
et al., 2004; Jiménez-Escrig et al., 2006; Klingberg et al., 2007). The phytosterols
are typically approximately 90% of the total phytosterol/phytostanol mix in a food.
A study of 200 consumers of a typical German diet showed excretion rates of
10–25 mg phytostanols/day, taken to be equivalent to background exposure, as the
phytostanols have very limited absorption in the human gut.
3.4.2 “Directed” exposure from food
As discussed above, consumers of foods containing phytosterols,
phytostanols and their esters are directed to consume them in one, two or three
portions a day in order to achieve a physiologically effective dose of 2 g free
phytosterols and/or phytostanols (3.4 g/day of the esterified forms). The Committee
was aware that products containing phytosterols, phytostanols or their esters are
markedly more expensive than the same products without them (up to 5 times the
cost for some products in the United Kingdom market, as reported in European Food
Safety Authority, 2008) and concluded that inadvertent purchase and consumption
of such products over a lifetime were highly unlikely. Additionally, in the EU, labelling
is required on food products containing phytosterols, phytostanols or their esters,
stating that consumption of more than 3 g/day should be avoided. Therefore, the
Committee concluded that dietary exposure to free phytosterols and phytostanols
would be no more than 30 mg/kg bw per day for a 60-kg individual.