Merck KGaA subsidiary Merck Eprova won approval yesterday to use its calcium L methylfolate ingredient in dietary supplements sold in the European Union.
The go-ahead came after the ingredient, called Metafolin, was added to the positive list of vitamins covered in the EU Directives for food supplements and foods for nutritional uses.
Metafolin is a more bioavailable form of folate compared with folic acid, which must be metabolized by the body. The approval follows clearance by the US Food and Drug Administration (FDA) in 2001, a 2004 authorisation from the European Food Safety Authority (EFSA) and a positive evaluation by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in July 2005.
“Metafolin is a proprietary folate with excellent bioavailability,” said Roger Weibel, product manager of Switzerland-based Merck Eprova. “We believe Metafolin is an interesting tool for a differentiation strategy in a highly competitive market.”