EU Commission Approves MK-7 Vitamin K2 from Bacillus subtilis as Novel Food for Adults

The European Commission has finalized the implementing regulation for MK-7 Vitamin K2 derived from Bacillus subtilis natto. This update follows the EFSA safety assessment which confirmed the stability and bioavailability of this specific fermentation source. The ruling clears the path for brands to market high-dose K2 products without the previous restrictive hurdles associated with non-synthetic sources.

Authorized Limits and Specification Requirements

The new regulation sets specific purity standards and daily intake limits that differ from previous synthetic benchmarks. Formulators must ensure their raw material COAs match the new Union list specifications to remain compliant.

• Maximum daily intake set at 200mcg for the adult population.
• Minimum purity level of 98 percent all-trans menaquinone-7 required.
• Total bacterial count must be below 1000 CFU per gram in the raw material.
• Mandatory labeling requirement stating the product is not suitable for people taking anticoagulants.

Sourcing and Procurement Impact

Prices for European-origin MK-7 fermented oil are currently holding at 4200 EUR per kg for a 1500ppm concentration. While synthetic K2 remains cheaper at roughly 2800 EUR per kg, the marketing shift toward natural fermentation is expected to drive a 15 percent volume increase in the fermented segment by year-end. If you are launching a bone health complex in Q4, I recommend securing fermented MK-7 now as lead times for certified batches are stretching to 10 weeks.

Procurement managers should audit their current suppliers to ensure they possess the specific strain validation mentioned in the updated Annex to Regulation EU 2017/2470. Using a non-validated strain will lead to rejection at the notification stage in markets like France and Belgium.