[Foods fortified with phytosterins: their role in decreasing serum cholesterol level, their European Community authorization and requirements for placing them on the market].

Phytosterols are isoprene compounds that may be found in a great variety of different food products. The most important phytosterol compounds are beta-sitosterol, campesterol and stigmasterol. Plant sources of phytosterols are oily seeds, nuts, plant oils, grains, and pulses. Many controlled clinical studies have demonstrated their ability to reduce blood cholesterol levels in hyper- and normo-cholesterolaemic subjects. Investigators report that phytosterol intakes of 2 to 3 g/d reduce low-density lipoprotein (LDL) cholesterol levels by about 7-11% in human subjects, while LDL and TG levels do not change. Phytosterol intake higher than 3 g daily does not result in higher decrease of LDL level, but about consumption of 8.6 g per day does not have any detrimental effect on human health. A documented side effect of elevated phytosterol intake is the reduced level of certain carotenoids in sera but this effect can be balanced by increased consumption of fruits and vegetables rich in carotenoids. Subjects having hereditary sitosterolemia are highly advised to refrain from consuming foods supplemented with phytosterols. While dietary intake of phytosterols is too low to achieve significant reduce of cholesterol level, based on the Community legislation of 258/97/EC regulation related to novel foods and novel food ingredients, the European Union authorized to use phytosterols in certain food products at a concentration which resulted in a daily phytosterol intake less than 3 g. A European survey of the European Food Safety Authority (EFSA) shows that only 10-15% of the population consume foods supplemented with phytosterols, and phytosterol intake is less than the effective dose. Based on this survey it is supposed that the risk of phytosterols overdose is low. EFSA also stated that--based on the relevant scientific information--regular intake of foods supplemented with phytosterols/phytostanols is in significant correlation with reduced serum cholesterol level. Based on this statement, authorized foods supplemented with phytosterols will be the first food group legally having health claim for reduced risk of disease since the new Community legislation on nutritional and health claim on foods 1924/2006/EC exists. Consumers will have a scientifically substantiated health claim on the label of these foods: "Plant sterols/stanols have been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of coronary heart disease."