Safety evaluation of certain food additives - ipcs inchem

150 PHYTOSTEROLS, PHYTOSTANOLS AND THEIR ESTERS
3.4.3 Potential overconsumption of phytosterols/phytostanols
The convenience of numerous products containing phytosterols,
phytostanols or their esters has raised regulatory concerns about possible
overconsumption, defined in the EU as dietary exposure to more than 3 g/day. In
the USA, while no concerns have been raised concerning potential for overconsumption,
an estimate of 90th-percentile exposure to the phytosterols,
phytostanols and their esters of 8 g/day (60% of 12.9 g/day reported for the esters
of phytosterols/phytostanols) was published in a letter to a recent GRAS Notice
(GRN 000206), assuming that individuals would consume all possible products
containing them at the suggested upper use level.
To address any concerns, EFSA completed and published an analysis of
the potential for exceeding 3 g/day dietary exposure to phytosterols, phytostanols
and their esters (European Food Safety Authority, 2008). Data from Belgium,
Finland, France, Germany, the Netherlands, Ireland and the United Kingdom were
examined. Current and potential future exposure scenarios were included.
Additionally, the market share for products containing phytosterols, phytostanols or
their esters was considered.
Based on studies in Germany, Ireland and the United Kingdom, the report
concludes that current exposure to the phytosterols, phytostanols and their
esters in those markets is less than 2.5 g/day at the mean and 6.6 g/day at the
97.5th percentile (both figures from the Irish study). A post-launch monitoring study
across five countries showed mean dietary exposure ranging from 1.0 to 1.9 g/day,
with 95th-percentile dietary exposure ranging from 2.2 to 3.6 g/day. Of consumers
of phytosterol/phytostanol-containing products in this study, 79–95% were
over the age of 45. Also in this study, 5% reported consuming phytosterols/
phytostanols above the 3 g/day level. A lower percentage exceeded 3 g/day in
Germany and the United Kingdom, but 23%, mostly long-term consumers of
phytosterols/phytostanols, reported dietary exposures above 3 g/day in Ireland.
These studies found that less than 5% of consumers reported eating three portions
per day of a food containing phytosterols/phytostanols.
The EFSA report concludes:
In general there seems so far to be little over-consumption of food products with
added plant sterols, rather some consumers don’t eat enough of the products to
gain a real benefit. Modeling showed that consumption on more than three
occasions per day or daily consumption of two or more products each at their
respective recommended intake level was necessary to exceed a daily intake of
3 g of plant sterols.
The Committee concurred with this conclusion.