Vitae Naturals range of plant sterols and plant sterol esters under the
brand Vitasterol® has achieved self-affirmed GRAS (generally recognized
as safe) status in a variety of food and beverages applications. This
process started two years ago and an expert and qualified panel
evaluated the composition, identity, methods of manufacture,
specifications, estimates of dietary exposure and published
Vitasterol® brand includes free plant sterols, plant sterol esters and water dispersible plant sterols. Vitae has widen this range to facilitate the incorporation of sterols to food products. Vitasterol® ingredients are non genetically modified, identity-preserved.
Foods and beverages containing Vitasterol® could display on their label the approved health claim for sterols in US: Foods or beverages containing at least 0.4 g plant sterols, when consumed twice a day with meals for a total intake of 0.8 g/day as part of a diet low in saturated fat and cholesterol, may reduce the risk of coronary heart disease.
The health benefits of consuming 2,5-3 g plant sterols to reduce cholesterol levels up to 12,5% have been supported by large clinical research.
Vitae Naturals has carried out several notifications and register process in different countries to approach and enter new markets. In 2006 Spanish Food Safety Agency delivered substantially equivalent opinion on Vitae Naturals Vitasterol® according to Novel Food Regulation No. 258/1997 and European Commission notified it to all Member States. At present Vitae Naturals ingredient could be added to all food approved categories in Europe. In 2013 Vitae Naturals submitted also Novel Food (NF-281) for Vitasterol® in Canada and in 2014 has won approval to commercialize their Vitasterol® sterols in Brazil such as novel ingredient.