The approval is expected to significantly boost the current European vitamin K2 production level of about two metric tonnes.
The European Commission Standing Committee on the Food Chain and Animal Health (SCFCAH) gave the authorisation in February, following a European Food Safety Authority (EFSA) positive opinion in November.
Once it has been formally written into the European legislature, expected in weeks, the SCFCAH authorisation means vitamin K2 can be employed in food supplements and a host of functional foods as well as cosmoceutical applications.
K2, or menaquonine, is usually sourced from natto – a popular soy food in Japan – and is a vitamin whose star seems to be rising as studies mount demonstrating its ability to benefit heart, skin and bone health as well as fighting the onset of some cancers such as prostate.
The Novel Foods application was made by Norwegian K2 specialist, NattoPharma, in regard to its proprietary K2 form, MenaQ7.
NattoPharma recently signed a deal with Danish supplier Danisco BioActives that will see Danisco become the marketer and distributor of Natto’s vitamin K2 ingredient to the food industry.
"The Novel Food authorisation is a great achievement by NattoPharma as the first, big barrier to full EU approval now has been passed,” said NattoPharma vice president of research and development, Anne Bjørnebye Vik.
“This is a major market break-through for us, since we are now able to start selling our MenaQ7 as Novel Food in EU."
Previously, K2 could only be sold in select European markets where a derogation applied such as the UK, Sweden, Denmark, Poland and Belgium. Now K2 will also be available in markets like France, Germany, Spain and Portugal where no previous derogation was in operation.
NattoPharma has submitted dossiers to the EU nutrition and health claims regulation, due to be resolved by January, 2010.