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Cognis achieves FDA GRAS status for Tonalin® CLA

No. 1 brand of CLA safe for broad range of foods and beverages

(PresseBox) (Monheim, ) Global specialty chemicals supplier Cognis announced that the U.S. Food and Drug Administration (FDA) issued a no questions letter to Cognis' GRAS notification (GRN 00232). Cognis' Tonalin®, the most clinically studied brand of CLA (conjugated linoleic acid), has achieved FDA GRAS (generally recognized as safe) status and can be utilized in an expanded range of functional foods and beverages in the US market.

After self-affirming Tonalin® as GRAS in 2004 in consultation with a panel of independent experts, Cognis submitted this voluntary notification to the FDA in cooperation with Lipid Nutrition, another branded CLA manufacturer. The FDA's written response provides assurance to food manufacturers and consumers that the FDA has reviewed the submitted safety evidence and has no questions about the overall GRAS conclusion for Tonalin® in its intended use various food applications.

Natural-source and highest quality
CLA from Cognis Nutrition & Health is the most clinically-tested CLA, having been used in the majority of human trials on body composition. Tonalin® is produced through a proprietary process using linoleic acid from safflowers to create the highest quality of commercially available CLA. A naturally sourced product, it comes in several forms, such as oil and water-dispersible powder making it suitable for applications in food, beverages and dietary supplements. Approved food applications include milk and flavored milk products, yogurt products, fruit juice products, soy milk beverages and meal replacement beverages and bars. In addition to the applications above, Cognis' Tonalin® is also self-affirmed GRAS for coffee creamers and chocolate.

Potential for the success of Tonalin® in food products was also demonstrated in recent research on its effects in a skimmed milk product. Results of the randomized, double-blind, placebo-controlled trial showed a significant reduction of body fat mass (BFM) in overweight subjects, indicating that CLA can be as beneficial in a functional food matrix as it is when taken in a supplement.1

"Tonalin® could help revolutionize the way people reduce body fat," said David Eckert, Vice President North America, Cognis Nutrition & Health. "Our goal is to support our customers as they help consumers achieve their body composition goals with delicious, yet healthy foods and beverages. As the most recognized brand of CLA, Tonalin® is the ingredient of choice for functional food and beverages targeting consumers interested in safely and effectively improving their body composition by reducing body fat.

Eckert pointed out that Cognis offers a unique service perfect for food companies interested in launching new products with Tonalin®. "We help our customers avoid the often time-consuming and costly hurdles often associated with adding new functional ingredients.

In addition to FDA GRAS notification Cognis has also applied for Novel Food authorization for CLA in functional foods in Europe, with the official submission of a comprehensive dossier on its leading Tonalin® CLA brand in 2007. The Spanish authority for Food Safety and Nutrition (AESAN) has just finalized its assessment of Tonalin® in the EU's Novel Food authorisation process. The AESAN opinion will now be submitted and reviewed by the other Member States. Achieving an approval at the end of this complex procedure will also enable Cognis' customers to take advantage of Tonalin®'s unique benefits for functional food applications in Europe.

Tonalin® CLA is an exclusively licensed product of the Cognis Group.

1 Laso, N., Bruque, E., Vidal, J., Ros, E., Arnaiz, JA., Carne, X., Vidal, S., Mas, S., Deulofeu, R., Lafuente, A.: Effect of milk supplementation with conjugated linoleic acid (isomers cis-9, trans-11 and trans-10, cis-12) on body composition and metabolic síndrome components. Br J Nutr 2007; Jul 11: 1-8

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 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, textiles, as well as agriculture and mining. The subsidiary Pulcra Chemicals offers specialized chemical products and process expertise to customers in the fiber, textile, and leather industries. Cognis also holds a 50-percent stake in the joint venture Cognis Oleochemicals, one of the world's leading manufacturers of oleochemicals.

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.