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FDA acknowledges GRAS notification for BASF synthetic lycopene
Nutritional supplement used in tablets or to fortify food and beverages

MOUNT OLIVE, N.J., August 21, 2003 – The U.S. Food and Drug Administration (FDA) has acknowledged that BASF provided sufficient information to conclude that its synthetic lycopene is a Generally Recognized As Safe (GRAS) substance.

Substances directly added to foods like BASF's lycopene must either be GRAS or the subject of a food additive petition. BASF followed FDA-proposed procedures to establish that its lycopene product is GRAS. This process included convening an expert panel to review the necessary product data, and then submitting a voluntary notification to FDA of the expert opinion and the data supporting its conclusion. FDA's response to the notification offered no questions that BASF's synthetic lycopene is GRAS.

BASF's Human Nutrition business offers three commercial synthetic lycopene products: Lycopene 10 Percent (tablet grade, powder), Lycopene 10 Cold Water Dispersion (powder) and Lycopene Dispersion 20 Percent (liquid). Typical uses for these materials include nutritional dietary supplement tablets and as a direct ingredient to fortify various commercial food and drink products.

"Scientific evidence is beginning to indicate that lycopene may reduce the risk of many types of cancers and cardiovascular disease," said Mike Doyle, Director, Human Nutrition, BASF Corporation. "Receiving this positive acknowledgment to our GRAS notification from the FDA culminates a 10-year developmental product safety evaluation project for BASF to provide high-purity lycopene to the marketplace. We will continue to support our customers in incorporating this potent nutritional antioxidant into their products that will benefit consumers."

Natural sources of lycopene include certain vegetables, especially tomatoes, and fruit, such as watermelon, pink grapefruit and apricots. However, people would have to eat massive quantities to provide the concentration recommended by researchers, said Dr. Herbert Woolf, Technical Manager, Nutraceuticals, BASF. "For example, vegetarians, who have a low incidence of prostate cancer, consume about 14 milligrams of lycopene daily. In contrast, the average American diet provides about 7 milligrams of lycopene daily. For many Americans not consuming a balanced diet, the next best way to get the benefits of lycopene is to consume a lycopene supplement or processed foods fortified with lycopene," he said.

BASF: Helping Make Products Better™
BASF is the world's leading chemical company, offering its customers a range of high-performance products, including chemicals, plastics, performance products, agricultural products, fine chemicals as well as crude oil and natural gas. Its distinctive approach to integration, known in German as "Verbund," is its strength. It enables BASF to achieve cost leadership and gives the company a competitive advantage. BASF conducts its business in accordance with the principles of sustainable development. In 2002, BASF had sales of $34 billion and more than 89,000 employees worldwide. BASF Corporation is the North American affiliate of BASF AG, Ludwigshafen, Germany. In North America, 2002 sales were approximately $8.2 billion and the company employs approximately 12,000 people. For more information or to receive news releases by e-mail, visit, visit www.basf.com/usa.

For more information, contact:
David A. Elliott
BASF Corporation
Tel: (248) 948-2067
E-mail: elliotd1@basf.com

     
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