Jan. 28, 2003, LaGrange, IL -- Cognis Nutrition and Health, a global leader in the manufacture and innovation of nature-based ingredients and application technology for health and food products, today announced that the U.S. Food and Drug Administration (FDA) has no questions about Cognis’ determination that its XANGOLD® brand natural lutein esters products are Generally Recognized As Safe (GRAS) for addition to a variety of foods.
XANGOLD® is the only source of lutein to complete this GRAS notification process. After self-affirming XANGOLD® as GRAS in 2002 in consultation with a panel of independent experts, Cognis submitted this voluntary notification to the FDA. Conclusion of the notification procedure (by FDA’s written response) provides assurance to food manufacturers and consumers that the FDA has had an opportunity to review the safety evaluation of XANGOLD® for its intended food use.
XANGOLD® lutein esters, extracted from marigold flowers, provide a natural source of the important carotenoid lutein found in dark green and yellow-orange vegetables and fruits. Lutein is being studied for its potential benefits in the maintenance of eye health. Lutein and a related carotenoid, zeaxanthin, make up the macular pigment, the central part of the retina that allows us to clearly see fine details. Future studies will help reinforce recent findings indicating that intake of natural lutein esters was associated with increased macular pigment density, which may help keep eyes healthy as we age.
“We are gratified that the FDA had no objection to our GRAS determination for XANGOLD®, paving the way for its use in specific foods,” said David Eckert, Business Director, North America, Cognis Nutrition & Health. “This added safety assurance is a benefit we are pleased to offer our customers in the functional foods and dietary supplements markets as they develop new products for lutein esters, an effective source of lutein. Now food manufacturers get a double bonus with XANGOLD® - an ingredient that is GRAS and also offers appealing manufacturing benefits via excellent stability and long-lasting potency,” Mr. Eckert pointed out.
XANGOLD®, the newest product in the family of Cognis antioxidants, is offered for use in baked goods and baking mixes, beverages, frozen dairy desserts and mixes, processed fruit and vegetable products, egg products and egg substitutes, breakfast cereals, dairy products, spreads, and other foods.
XANGOLD® is available as a 15% concentrated oil-based product and a 10% concentrated beadlet product that can be added in amounts ranging from 2-6 mg lutein esters per serving. Based on chemical conversion, this is equivalent to approximately 1-3 mg lutein per serving. While most Americans consume 1-2 mg of lutein per day, some research suggests that at least 6 mg per day is needed for eye benefits. Water dispersible XANGOLD® products are under development for potential future use in even more food applications.
For more information about XANGOLD® natural lutein esters in North America, call 1-800-673-3702 to place an order, e-mail to [email protected] or send a fax to 1-513-482-3576. For more information in Europe, call +49-211-7940-9692, e-mail
[email protected], or fax +49-211-798-2390. For more information in Asia Pacific, call +61-3-9584-4588.
Cognis (www.cognis.com) is a worldwide supplier of innovative specialty chemicals and nutritional ingredients with almost 9,100 employees in close to 50 countries. The company has dedicated its activities to a high level of sustainability and delivers natural-source ingredients for food, nutrition and healthcare markets and serves major customers in the cosmetics, detergents and cleaners industries. Additionally, Cognis provides solutions for a number of other industries such as, coatings and inks, lubricants, textiles and plastics as well as agrosolutions and mining chemicals.
Cognis is owned by private equity funds advised by Permira, GS Capital Partners, and Schroder Ventures Life Sciences. In 2001, Cognis recorded sales of 3.1 billion euros and an operating profit of 174 million euros. In the first half-year of 2002, sales were 1.6 billion euros.
Cognis Nutrition and Health, a business unit of Cognis Group, provides antioxidant, botanical and nature-based ingredients for dietary supplements; pharmaceuticals and healthcare; functional foods and medical nutrition; and animal nutrition. As a leader in food technology, Cognis manufactures emulsifiers, emulsifier-based compounds, and numerous other specialty products for the food industry worldwide.