EFSA could not set a safe daily intake level
When the European Food Safety Authority reviewed this additive in 2012, it concluded that the toxicological data available for stigmasterol-rich plant sterols in this concentrated, purified form were insufficient to establish an acceptable daily intake. This is not the same as finding a harm, but it means the regulator was unable to draw a confident safety boundary from the available evidence. EFSA judged that the amounts consumed from the narrow permitted use (ready-to-freeze cocktails only) were unlikely to raise concern in practice, but the underlying data gap was acknowledged and no ADI was set.
EFSA concluded that toxicological data for stigmasterol-rich plant sterols as a food additive were insufficient to establish an acceptable daily intake, though it considered the proposed use in ready-to-freeze cocktails unlikely to raise safety concerns given the exposure level.
2012Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources Added to Food (ANS), EFSA Journal
Plant sterols and cholesterol absorption
Plant sterols as a class (including stigmasterol) compete with dietary cholesterol for absorption in the gut, reducing the amount of cholesterol that enters the bloodstream. This is the basis for plant sterol functional foods marketed for heart health. However, the amounts of E499 delivered by ready-to-freeze cocktails at their permitted levels (80 to 800mg/kg) are too small to produce a meaningful cholesterol-lowering effect. At the same time, plant sterols at high intakes can reduce absorption of fat-soluble vitamins and carotenoids, though this has not been studied specifically for E499 at these concentrations.
Plant sterols at doses of 1.5 to 3 g per day reduce LDL cholesterol by approximately 10%, but this level is far above what would be consumed from the narrow food additive use of E499.
2012Meta-analysisEFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), EFSA Journal
Regular consumption of plant sterols at elevated intakes has been associated with modest reductions in plasma carotenoid and fat-soluble vitamin levels in controlled studies.
2000ObservationalLaw M, BMJ
Sitosterolaemia: a rare genetic condition that requires avoidance
People with sitosterolaemia (also called phytosterolaemia) have a rare inherited metabolic disorder that causes plant sterols to accumulate in the blood and tissues rather than being excreted. In these individuals, dietary plant sterols including stigmasterol can contribute to premature cardiovascular disease, xanthomas (fatty deposits under the skin), and joint problems. The condition is rare but serious, and those affected are advised to restrict all plant sterol intake.
Sitosterolaemia is caused by loss-of-function mutations in the ABCG5 or ABCG8 transporter genes, leading to abnormal accumulation of plant sterols in plasma and tissues and associated cardiovascular risk.
2000EstablishedBerge KE et al., Science