Make sure you understand vitamin K2 status in EU market, because “price matters” approach may put your product in a breach of the food law.
Vitamin K2 is considered a novel food according to Regulation No. 2017/2470. Synthetic menaquinone-7 authorization was first issued to a Norwegian company Kappa Bioscience AS in 2012. The document approving the product in the EU included acceptable safe levels of impurities: maximum 6% of the cis isomer and maximum 2% of other unknown impurities.
For "natural" vitamin K2, the first authorization was issued to a Norwegian company Nattopharma ASA. The EFSA-authorized microbiological process uses a strain of Bacillus subtilis spp. natto, and results in a final product containing max 1% MK-6 impurity and max 2% of the sum of all unknown impurities.
In accordance with current EU laws, all manufacturers and importers of vitamin K2 are required to meet the above-mentioned quality criteria, or to classify the ingredient they introduce as the novel food subject to a separate authorization.
Price is the preferred criteria for many companies, however the cheapest vitamin K2 is of synthetic origin and its purity is below authorized levels. As for biotech products from Asia, they also present significantly different impurity profile to the originally approved “natural” product, thus such process cannot be called equivalent.
