US firm wins EU novel foods approval for vitamin K2


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US firm wins EU novel foods approval for vitamin K2

Related tags Novel foods approval European union European commission Nutrition European food safety authority

Indiana firm Vesta Ingredients has won EU novel foods approval for its vitamin K2 form as it has been determined to be equivalent to a form already on-market and proven to be safe.

The opinion was delivered by the Food Safety Authority of Ireland (FSAI) and the nutrient has been validated by the European Commission as being equivalent to Norwegian firm Natto Pharma’s MenaQ7. Under centralised European Union laws, Vesta’s similarly named Menaquinone-7 (MK-7) becomes available across the 28-nation bloc.

The EC said in a missive: “The FSAI has delivered an opinion that vitamin K2…is substantially equivalent to the vitamin K2 authorised by Commission Decision 2009/345/EC with respect to composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein…”

DuPont Nutrition & Health and Norway-based Kappa Bioscience won novel foods approval for their version of vitamin K2 in 2012, marketed as MK-7 and ActivK S.

In that arrangement, Kappa manufactures and markets the ingredient to food supplements markets, while DuPont takes ActivK S to food markets.

Vitamin K2 has a European Food Safety Authority (EFSA)-approved general function health claim for bone health, and evidence suggests heart and skin health benefits.

The ingredient has sold for prices up to €1000 per kilogram for 1000 parts per million versions, but has gone much lower.

Vesta worked with French consultancy and contract research organisation Nutraveris to gain the EU novel foods approval. The vitamin K2 form is distributed by CLS Technology in European markets.

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