NattoPharma clears EU safety hurdles to win green light for vitamin K2

Norway's NattoPharma is celebrating after gaining permission to use its vitamin K2 ingredient in functional foods and supplements throughout the European Union.

The company said it was "extremely proud" to have finally won approval for MenaQ7 after a three-stage process which began almost a year ago with the granting of a positive scientific opinion by the European Food Safety Authority in November 2008. This was followed by Novel Food approval in April this year and, earlier this month, formal endorsement of the ingredient by the European Commission.

MenaQ7 is extracted from fermented soybeans, which provides natural vitamin K2 in the form of menaquinone-7, a long chained molecule said to offer superior bio-availability and health effects in low doses, and which has been linked with benefits to bone and cardiovascular health.

The ingredient will appear on EU's list of approved ingredients as vitamin K2 specified as menaquinone-7 and traces of menaquinone-6. Nattopharma said this was a particular form of Vitamin K2, which meant it alone was able to market this ingredient in the EU.

"With interest in the vitamin K2 market growing rapidly, NattoPharma now has an important competitive advantage, as the EU approval has been given based on our production process and product specifications," claimed Nattopharma CEO Thomas Christensen. "When the new official vitamin list is published, which will be soon, we will be the only company that can legally sell vitamin K2 in the EU, which is a must for success in the market."

The EU did not publish branded product names in its legislation, he said, warning: "We are aware that the description might confuse actors in the market to believe that all products with this vitamin K2 content are now legal. However, no other vitamin K2 products than MenaQ7 are presently approved for sale in the EU. Our competitors must recognise that it is their responsibility to apply for relevant authorization and to comply with all relevant Community food laws. We are extremely proud that NattoPharma's clinical investment and regulatory work over several years has finally resulted in a positive regulatory position for our vitamin K2 product . Customers are now able to introduce MenaQ7 products in all EU countries."

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