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Australian Therapeutic Goods Administration (TGA) Announces Listing of Vegetable Oil Phytosterol Esters in Capsules

The Australian Therapeutic Goods Administration (TGA) has announced listing of vegetable oil phytosterol esters , (also known as plant sterol esters) in dietary supplements such as soft gelatin capsules.

The Australian TGA has a reputation for being very strict and thorough in their assessments, and their decision is consistent with approvals by Food Standards Australia and New Zealand (FSANZ), as well as many other regulatory authorities around the world. Countries in South East Asia often take their lead from the TGA, such as Malaysia.

About 1.3 million of the 21 million or so Australians over 45 have cholesterol levels above the target of 200mg/dL (or 5.1mMol/L). Elevated cholesterol is associated with around one-third of all cardiovascular diseases such as atherosclerosis, and over half of all incidences of coronary heart disease.

“I’m personally very pleased that Australians now have another safe, natural and effective choice to help lower their cholesterol”, said Simon Lord, Regional Business Manager for Cognis Australia, who put forward the application to the TGA. “Foods and beverages containing plant sterol esters such as table spreads and milk are well established in the market and in the coming months we should see capsules on the shelf. An advantage of capsules is that they provide a convenient way to consume these beneficial plant sterols esters in a portable, measured dose.”

Plant sterol esters occur naturally in foods such as nuts and legumes, but most people do not consume nearly enough in a modern diet to receive the full benefits. Plant sterols compete with cholesterol from food, and with cholesterol made by the body, for absorption into the body.

Consuming dietary supplements containing plant sterol esters is an easy, safe, and natural way to lower cholesterol, (Lipids in Health and Disease 2007, 6:11). The recommended consumption of plant sterol esters is 2-3g per day, with a minimum of 1.3g per day. Results are usually evident within a month. The TGA require that products are labeled “There is no benefit from taking more than 3g/day of phytosterols from all sources” and “Not suitable for pregnant or lactating women”.

Vegapure® phytosterol esters are safe and effective in combination with statin medication showing an additive effect (Am J Cardiol 2002, 90: 737-740; Curr Opin Investig Drugs. 2005; 6: 307-16). Consumers should consult their physician for more information. To complement plant sterol esters, the omega-3 fish oil essential fatty acids, EPA and DHA, are an excellent combination which further improves triglyceride levels (J Nutr 2008, 138: 1086–1090) as well as offering the many other established benefits of EPA and DHA. Cognis also supplies standard, flavored, and concentrated fish oils under the OmevitalTM trade name.

Mr. Lord also reminded that “plant sterol esters should be part of an overall strategy for cholesterol reduction, including reduced saturated and trans-fats, increased fiber, and regular exercise”.

For more information about Vegapure® plant sterol esters, visit, or contact your local Cognis Representative.

About Vegapure® Natural Plant Sterol Esters:
Cognis Nutrition & Health offers the broadest portfolio of natural plant sterols and sterol esters for cholesterol-lowering products, including non-GMO and IP-certified forms. With more than a 60 percent market share in the global food industry, Cognis is the sterols supplier for many of the best known consumer brands sold worldwide. Its new $25 million high-performance production facility assures security of supply. Consumers can find Cognis’ branded plant sterol ingredients under the Heart Choice® name in the USA and under Vegapure® name elsewhere.

About Cognis:
Cognis ( is a worldwide supplier of innovative specialty chemicals and nutritional ingredients, with a particular focus on the areas of wellness and sustainability. The company employs about 7,600 people, and it operates production sites and service centers in 30 countries. Cognis has dedicated its activities to a high level of sustainability and delivers natural source raw materials and ingredients for food, nutrition and healthcare markets, and the cosmetics, detergents and cleaners industries. Another main focus is on products for a number of other industries, such as coatings and inks, lubricants, as well as agriculture and mining.
Cognis is owned by private equity funds advised by Permira, GS Capital Partners, and SV Life Sciences. In 2007, Cognis recorded sales of about 3.52 billion euros and an Adjusted EBITDA (operating result) of 410 million euros.

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