Kensing has announced the exclusive EU authorisation of Sunvasterol, a next-generation of plant sterols sourced from sunflower seeds.
This EFSA approval for sunflower phytosterols offers food formulators and dietary supplement brands a clean-label, allergen-free, sustainably sourced alternative to traditional soy, rapeseed and pine-based sterols clinically proven to reduce cholesterol.
Sunvasterol pure sunflower sterols are derived from sunflower oil distillates.
Developed and produced at Kensing’s facilities in Valencia and Talavera de la Reina, Spain, from an upcycled, valuable byproduct of sunflower oil, Sunvasterol exemplifies Kensing’s commitment to circularity and minimising waste.
Science-backed cholesterol reduction
Phytosterols are a natural lipid component of oil seeds, grains, nuts, legumes and other plant seeds.
They reduce cholesterol by competing with dietary and biliary cholesterol for absorption in the intestines, thereby lowering the amount of cholesterol entering the bloodstream.
This absorption inhibition helps to reduce total and LDL-cholesterol levels. The positive effects on total and LDL-cholesterol are well supported by extensive scientific literature comprising more than 140 published studies.
Sunflower phytosterols are supported by EFSA-approved health claims indicating that a daily intake of 1.5-3.0 g can help reduce total and LDL cholesterol by about 7-12% during 2-3 weeks when incorporated into authorised food categories.
A daily intake of at least 0.8 g of plant sterols can help maintain healthy cholesterol levels.
Since 2000, sterols and stanols from soy, pine and other plants have enjoyed EFSA authorisations for their role in helping to lower blood cholesterol.
A full Novel Food dossier was submitted to seek approval for sunflower-based phytosterols with a broader specification for use in food supplements and fortified foods.
This amendment refers to the allowance of higher amounts of “other sterols/stanols” naturally occurring in the specification to better reflect the natural composition of Kensing’s sunflower-derived sterols.
Commercial Exclusivity
Following an evaluation of Sunvasterol through the EFSA Novel Food application process, the new and specific EFSA approval grants Kensing commercial exclusivity in Europe.
This means that Kensing is currently the exclusive holder of this authorisation.
Other producers seeking to enter the European market commercially with the same type of sunflower sterol product will either be required to file their own dossier through EFSA or obtain consent from Kensing.
“We are very excited to receive this approval, which allows us to offer an additional source of non-GMO, allergen-free phytosterols that are fully disconnected from deforestation and traceability challenges, providing a sustainable alternative,” said Serge Rogasik, CEO of Kensing.
“The EFSA approval confirms that sunflower-derived phytosterols deliver a strong cholesterol-lowering benefit, similar to our other EFSA-approved sterols."
"Sunvasterol achieves this with no compromise on efficacy, while enhancing the natural profile of the ingredient."
"We are a fully integrated producer of sunflower sterols and esters, allowing us to better control traceability.”
Kensing operates a globally integrated, resilient sunflower supply network spanning Spain, Argentina and the US, ensuring secure, scalable production with no reliance on tariff-sensitive imports.
The company will increase production capacity to meet new waves of product demand.
Versatile applications across food and nutrition
Sunvasterol is composed of concentrated phytosterols (primarily beta-sitosterol, stigmasterol and campesterol) in the form of free sterols and sunflower lipid-linked esters.
Esterification significantly increases the fat-solubility of plant sterols.
This means that, beyond supplements, they can easily be incorporated into fat-containing foods, including margarines and spreads, yoghurts, functional dairy drinks and other dairy products, milk-analogue products, condiments, salad dressings and much more.
Better-for-you product makers can easily formulate these everyday foods to carry cholesterol-lowering, heart-health functionality.
“Sunvasterol combines robust scientific validation and a smart formulation approach to create an ingredient that exerts minimal sensory impact on the carrier product."
“It does not affect the flavour or colour of foods and integrates smoothly into multiple food applications without requiring reformulation or processing changes,” Alejandro Abad, Executive VP and General Manager Europe for Kensing, added.
A complete natural sunflower portfolio
Sunvasterol joins Kensing’s portfolio of sunflower-based products, which also includes the Sun E vitamin E, offering a comprehensive sunflower-native platform that supports heart health, protection of cells from oxidative stress and overall wellness.
Products containing Sunvasterol can be labelled with a heart-health claim and as a naturally derived source of vegetable sterol esters.
All products are kosher, halal, non-GMO and upcycled.