About
What it is and where it shows up.
Vitamin K2 (as menaquinone-7, MK-7) is a fat-soluble member of the vitamin K family produced by bacterial fermentation, naturally found in fermented foods like natto and certain cheeses. It acts as an essential cofactor for γ-glutamyl carboxylase, activating Gla-proteins critical for normal blood coagulation, bone mineralisation, and vascular health.
Safety summary
The regulatory and scientific consensus.
Vitamin K2 (MK-7) has low acute oral toxicity with an LD50 above 2000 mg/kg in mice and a NOAEL of 10 mg/kg body weight/day in rats, with no compound-related toxicity observed. The primary clinical concern is its ability to interfere with vitamin K antagonist (VKA/warfarin) anticoagulant therapy; supplemental doses above 50 µg/day may affect INR in patients on such therapy. No formal ADI has been established by EFSA or FDA given its status as a safe nutrient source rather than a controlled food additive.
Regulatory landscape
What food-safety regulators have decided.
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Commission Decision 2009/345/EC authorised menaquinone (Vitamin K2) extracted from Bacillus subtilis natto as a safe source of Vitamin K for nutritional purposes in foods for particular nutritional uses, food supplements, and foods for the general population, under Regulation (EC) No 1925/2006 and Directive 2002/46/EC. No tolerable upper intake level (UL) has been formally set; EFSA human studies indicated consumption of up to 6 µg/kg body weight/day in adults did not adversely affect blood coagulation.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Vitamin K2-7 (Menaquin Gold®) approved by FSSAI under the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017; approval reference 46/Std/PA/FSSAI/2022 dated 22 July 2022. Permitted as a health supplement/nutraceutical ingredient; dose must comply with ICMR RDA limits per FSSAI nutraceutical regulations.source |
| FDA (Food and Drug Administration) (United States) | Approved | FDA issued a 'No Questions' response to GRAS Notice GRN 887 on 12 June 2020 for MK-7 (produced by fermentation of B. licheniformis DSM 24722) for use in nutritional beverage products at 4 µg/serving. Note: under 21 CFR Part 101, menaquinones are not included in the Nutrition Facts Panel definition of Vitamin K and must not be declared as such.source |
| FSANZ (Food Standards Australia New Zealand) (Australia) |
Who should approach with care
Whose guidance would steer them away.
Other — Patients on vitamin K antagonist anticoagulants (e.g., warfarin) should avoid supplemental MK-7 doses above 50 µg/day, as MK-7's long half-life can interfere with INR control and reduce anticoagulant efficacy, as noted in EFSA (2008) and the FSANZ A1300 application.
Children — Children undergoing anticoagulation therapy require haematologist oversight when consuming MK-7-containing foods or supplements, as dietary vitamin K interacts with anticoagulation medication and may alter therapeutic INR values, per FDA GRN 887 review.
Pregnancy — While no specific teratogenicity has been established for MK-7, supplemental doses in pregnancy should be taken under medical supervision as no formal upper intake level has been set by EFSA or FDA for this life stage.
Lactation — No formal upper tolerable intake level for MK-7 has been established for lactating women; supplementation beyond dietary levels should be discussed with a healthcare provider.
Research citations
The sources behind this verdict.
- 1FSSAI. List of products/ingredients approved under Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017, 2022. fssai.gov.in
- 2FDA. GRAS Notice GRN 887 Agency Response Letter – Menaquinone-7, 2020. fda.gov
- 3EFSA. Scientific Opinion on the substantiation of a health claim related to vitamin K2 and contribution to the normal function of the heart and blood vessels (ID 125, further assessment), 2012. efsa.europa.eu
- 4PubMed. Safety and toxicological evaluation of a synthetic vitamin K2, menaquinone-7, 2011. pmc.ncbi.nlm.nih.gov
- 5EFSA. Scientific Opinion of the Panel on Dietetic Products Nutrition and Allergies on a request from the European Commission on the safety of 'Vitamin K2', 2008. efsa.europa.eu
Independently researched5 citations