Phytosterol-enriched foods: Role in lowering serum cholesterol level, community authorising and conditions of marketing

Abstract

Phytosterols are isoprene compounds that may be found in a great variety of different food products. Most important phytosterol compounds are β-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 normocholesterolaemic subjects. Investigators report that phytosterol intakes of 2 to 3 g/day reduce low-density lipoprotein (LDL) cholesterol levels by about 7 to 11% in human subjects, while LDL and TG levels show no change. Phytosterol intake higher than 3 g daily results in no greater decrease of LDL level, but even the consumption of 8.6 g/day has no detrimental effect on human health. 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 sitosterolaemia are highly advised to refrain from consuming foods supplemented with phytosterols. As dietary intake of phytosterols is too low to achieve a significant reduction 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. European survey of European Food Safety Authority (EFSA) shows that only 10 to 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 phytosterol 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 enriched 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”.