Health ingredients manufacturer Cognis Nutrition and Health has announced that the US Food and Drug Administration (FDA) has approved GRAS status for the company's Xangold brand natural lutein esters products in a variety of foods.
Cognis claims that Xangold is the only source of lutein to complete this GRAS notification process. Cognis established its own GRAS affirmation for Xangold in 2002 in consultation with independent experts and then submitted this voluntary notification to the FDA. A written response from the FDA showed that the company had no questions regarding the safety of the ingredient for its intended food use.
Xangold lutein esters, extracted from marigold flowers, contain the carotenoid lutein found in dark green and yellow-orange vegetables and fruits. Recent research has connected dietary lutein to eye health and reduced risk of age-related macular degeneration.
US competitor Kemin Foods also has GRAS status for use of its FloraGLO brand purified lutein, also marketed as an eye health ingredient, in specific food and beverage applications.
Dr Franz Timmermann, manager for the functional foods segment at Cognis Nutrition & Health, said the news was an "added safety assurance" for customers in the functional foods and dietary supplements markets. He added that the ingredient also offers the appealing manufacturing benefits of excellent stability and long-lasting potency.
Xangold is Cognis' newest antioxidant and is designed for use in baked goods, beverages, processed fruit and vegetable products, egg products, breakfast cereals, dairy products, spreads, and other foods. The product is available both as a 15 per cent concentrated oil-based product and a 10 per cent concentrated beadlet that can be added in amounts ranging from 2-6 mg lutein esters per serving. Water dispersible Xangold products are also under development for use in new food applications.
Cognis is owned by private equity funds advised by Permira, GS Capital Partners, and Schroder Ventures Life Sciences. In the first half-year of 2002, sales were €1.6 billion.