Metafolin approved for use in dietary supplements and dietetic foods in EU

09/03/06 Merck Eprova AG has announced that Metafolin, its newly patented form of folate, has been approved in the European Union for use in food supplements (dietary supplements) and foods for particular nutritional uses (dietetic foods).

At its latest meeting in Brussels on February 9, 2006, the EU Standing Committee on the Food Chain and Animal Health (SCFCAH) voted to include Calcium L-Methylfolate (Metafolin) to the positive list of vitamins covered in the EU Directives 2002/46/EC (food supplements) and 2001/15/EC (foods for particular nutritional uses).

Metafolin (Calcium L-Methylfolate) belongs to the group of folate vitamins which the human body must obtain from the diet.

At present, folic acid is typically used as a source of folate for food supplements and vitamin-fortified foods. However, folic acid is an unnatural form of folate. It must first be metabolised by the human body before it can exert its vitamin function. In contrast, Merck Eprova’s Metafolin can directly be used by the body without further metabolic transformation.

The listing of Metafolin comes after the US Food and Drug Administration (FDA) notification in 2001, the positive evaluation by the European Food Safety Authority (EFSA) in October 2004 and the positive evaluation by JECFA (Joint FAO/WHO Expert Committee on Food Additives) in July 2005.

According to Martin Ulmann, General Manager of Merck Eprova AG, the vote of the Standing Committee opens the door for introducing Metafolin in the EU.

“This will enable us to provide EU consumers with a naturally occurring folate, at a time when there is growing awareness of the health benefits of folate supplementation."

"Food is the major source for folates. However, in a large part of the population folate intake with food is insufficient. An adequate intake of folates is essential for the prevention of 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 range of food supplements and medical foods in the U.S. since 2001. Now, Merck Eprova AG is ready to introduce Metafolin in the EU.

“Metafolin is a proprietary folate with excellent bioavailability. We believe Metafolin is an interesting tool for a differentiation strategy in a highly competitive market,” explained Roger Weibel, Product Manager of Merck Eprova AG. “Merck Eprova AG is proud of being able to make the naturally occurring, predominant form of folate now available to consumers throughout the EU.”