Vegetable sterols rich in stigmasterol
Score impact
+0.40
points/product
Description
The food additive E499, called 'vegetable sterols rich in stigmasterol', is a mixture of phytosterols obtained from vegetable oils, mainly soybean, corn, or rapeseed.
Industrially, it is obtained by extraction and purification of sterols present in vegetable oils, followed by a concentration process to enrich the stigmasterol content (at least 60% of total sterols). Physically, it appears as a white or slightly yellowish powder, insoluble in water but soluble in fats and organic solvents. Its main function is to reduce LDL cholesterol levels in the blood, acting as a competitive inhibitor of intestinal cholesterol absorption.
It was approved as a novel food in the European Union in 2004 (Regulation EC 258/97) and subsequently authorized as a food additive in 2014 (Regulation EU 2014/119). EFSA has evaluated its safety on several occasions, concluding that there is no specific acceptable daily intake (ADI), but that consumption in amounts up to 3 g/day is safe for the general population. The World Health Organization (WHO) has not established an ADI but supports its use as an adjunct in cholesterol reduction.
Regarding food safety, it is considered a safe additive, although it is recommended not to exceed 3 g/day to avoid possible adverse effects. On the label, it must appear as 'vegetable sterols' or 'E499', and in products that claim cholesterol reduction, a warning must be included that it is not recommended for people who do not need to control their cholesterol.
E499 is mainly used in functional foods intended to reduce cholesterol, such as margarines, yogurts, milks, spreadable cheeses, and dairy drinks.
In the Spanish market, products such as 'Danacol' (yogurt with vegetable sterols), 'Flora ProActiv' (margarine), and 'Leche Pascual con esteroles' are found. According to Regulation EC 1333/2008, it is authorized in the EU in categories such as 'spreading fats' (up to 8% sterols), 'dairy products' (up to 3 g/100 g), and 'milk-based drinks' (up to 3 g/100 ml).
The US FDA allows its use as a food ingredient (GRAS) in similar amounts, while Japan authorizes it as a functional food with limits of 1-3 g/day. It is not allowed to be added to foods for children under 5 years old or for pregnant women without medical supervision.
Documented adverse effects of E499 are mild and rare. The most common is reduced absorption of fat-soluble vitamins (A, D, E, and K) and carotenoids, because sterols compete for the same intestinal transporters.
Clinical studies have shown that doses of 2-3 g/day can decrease serum levels of beta-carotene by up to 20% and vitamin E by up to 10%. However, these effects are usually not clinically significant in people with a balanced diet. Other reported effects include mild gastrointestinal discomfort (diarrhea, constipation, nausea) in some individuals.
No serious drug interactions have been documented, although caution is recommended in patients taking statins or fibrates, as the cholesterol-lowering effect could be potentiated. Sensitive populations: people with sitosterolemia (a rare genetic disease causing sterol accumulation) should avoid it.
EFSA concludes that consumption of up to 3 g/day is safe for the general population, and WHO supports this assessment. No carcinogenic, mutagenic, or teratogenic effects have been established in animal studies.
- Phytosterols rich in stigmasterol
- Soy sterols
- Vegetable sterols
- Stigmasterol
- 24α-Ethylcholesta-5,22-dien-3β-ol
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