Metafolin ruled safe for use in supplements and foods by JECFA

Schaffhausen, Switzerland – Merck Eprova AG announced today that Metafolin, its new patented form of folate, has been approved as a safe alternative to folic acid for use in dietary supplements, foods for special dietary uses and other foods by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

Metafolin (the calcium salt of L-5-methyltetrahydrofolic acid or, for short, L-methylfolate) belongs to the group of folate vitamins (Vitamin B9, Folacin) which the human body must obtain from dietary sources.
At present, folic acid is typically used in dietary supplements and vitamin-enriched foods as a source of folate. However, not being a natural form of folate, folic acid must first be assimilated by the human body before it can exert its vitamin function. In contrast, Merck Eprova AG’s Metafolin can directly be used by the body without further metabolic transformation.
JECFA concluded at its latest meeting in Geneva on July 13, 2005, that there are no safety concerns with the proposed use of dry crystalline or microencapsulated Metafolin in dietary supplements and vitamin enriched foods.

The JECFA approval of Metafolin comes after the US Food and Drug Administration (FDA) notification in 2001 and the positive evaluation by European Food Safety Authority (EFSA) in October 2004. A positive evaluation by JECFA is an important first step for securing further approvals in many other countries around the World.

According to Martin Ulmann, General Manager of Merck Eprova AG, the JECFA report opens the door to making Metafolin a global product. “Metafolin is a product of several years of careful research. We are delighted that we will soon be able to offer the benefits of Metafolin to customers around the world. Now more consumers will have access to the natural form of this essential nutrient which is important for maintaining good health."

"Food is the major dietary source for folates. However, in large part of the population folate intake with food is well below the Recommended Dietary Allowance (RDA). An insufficient intake of folates is associated with an increased risk for many disorders including anaemia, neural tube defects, various forms of cardiovascular diseases, Alzheimer's disease, colon cancer and depression," commented Dr. Rudolf Moser, Scientific Director of Merck Eprova AG.

Metafolin has been used in a wide range of dietary supplements and medical foods in the U.S. since 2001. During 2005, Merck Eprova is preparing the launch of the ingredient into EU markets. “Metafolin is body-ready and is the only folate able to cross the blood brain barrier,” explained Roger Weibel, Product Manager of Merck Eprova AG. “Given a choice, we believe many health-conscious consumers will choose Metafolin as the preferred source of folate.”

Merck Eprova AG is a wholly-owned subsidiary of Merck KGaA of Darmstadt, Germany, and is the largest producer of specialty folates for oral and parenteral pharmaceutical applications and dietary supplements. Located in Schaffhausen, Switzerland, the company is a centre of excellence for research, development, production and marketing of pure and stable forms of folate derivatives.

Contact: Roger Weibel
Phone: ++41 [52] 630 7332
E-mail: [email protected]

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