Australian Therapeutic Goods Administration (TGA) announces listing of vegetable oil phytosterol esters in capsules

(PresseBox) (Monheim, ) 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 gelatine capsules.

High cholesterol is a major health concern. The proportion of Australian adults aged 25-64 years with high blood cholesterol (above 5.5mmol/L) is about 50%, or more than 6.4 million adults (Heart, stroke and vascular diseases, Australian facts 2004, Australian Institute of Health and Welfare). Also, the contribution of high cholesterol to coronary heart disease is about 56% (The Atlas of Heart Disease and Stroke 2004, WHO and US CDC).

"I am 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. "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 labelled "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, flavoured, and concentrated fish oils under the Omevital(TM) trade name.

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. Therapeutic Goods (Listing) Notice 2008 (No. 6) will be made available at http://www.tga.gov.au/legis/listing.htm.

The listing on the Australian Register of Therapeutic Goods (ARTG) can be found at https://www.ebs.tga.gov.au/ebs/ANZTPAR/PublicWeb.nsf/IngredientsPublicListed?OpenView&Start=3941&Count=20

BASF Personal Care and Nutrition GmbH

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 6,000 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 2.8 billion euros and an Adjusted EBITDA (operating result) of 360 million euros.

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