Vitamin K Quality and Labeling Standard
JHFC-S-027 Enacted: 7 September 2026 / Effective: the same day
Japan Certified Health Food Council (JHFC) — English translation of the standard. In case of discrepancy the Japanese text prevails. Japanese original
Japan Certified Health Food Council (JHFC)
Enacted: 7 September 2026 / Effective: the same day
Preamble (Rationale for Enactment)
The collective term vitamin K includes phylloquinone and menaquinones with different side chains. The designation “K2” alone cannot identify the homologue used, and the impurities requiring verification also differ between fermentation extracts and purified materials. In addition, in measurements of raw materials used in trace amounts, overlapping homologues or isomers affect the interpretation of labeled values. This Standard is established because names, separation analysis, and precautions for use need to be linked to the same product specification.
Article 1 (Purpose)
Vitamin K side-chain types and the composition of prepared raw materials shall be clarified to make the quality information underlying collective labeling verifiable. Common aspects of information disclosure shall be evaluated against the five criteria of JHFC-A-001, and this document supplements them with homologue identification and handling conditions.
Article 2 (Scope)
This Standard covers oral food products that label phylloquinone or menaquinones as constituent ingredients. Fermented materials, oil-diluted raw materials, and powdered preparations are also included. The chemical forms listed do not constitute a list of permitted raw materials; eligibility for food use shall be verified separately according to the form supplied and the region of sale.
Article 3 (Terms and Definitions)
- 1. Phylloquinone: The chemical form identified as vitamin K1.
- 2. Menaquinones: A group of homologues with different side-chain lengths collectively referred to as vitamin K2.
- 3. MK designation: An abbreviated designation distinguishing menaquinone side chains, such as MK-4 or MK-7.
- 4. Geometric isomer composition: The composition of cis, trans, and other forms distinguished for the target homologue.
- 5. Fermentation-derived fraction: A portion separated from fermented material that contains the target menaquinone and accompanying components.
Article 4 (Requirements)
1. Quality Requirements—Side-Chain Type and Purity
In addition to classification as K1 or K2, specifications for K2 shall include the MK designation used. Homologues shall be verified using separation data compared with reference standards, and where a specific isomer is labeled, documentation identifying that isomer shall also be available. The business operator shall establish specifications for the target homologue, isomers, and accompanying quinones and shall disclose the basis for those specifications, distinguishing it from a mere total peak area.
2. Quality Requirements—Fermentation and Purification Processes
For fermented raw materials, manufacturing documentation shall record microbial species, materials derived from culture media, extraction solvents, and cell removal processes. When fractions are mixed after purification, their homologue compositions shall be checked for consistency. During dilution in oil or conversion to powder, stock solution concentration and dilution history shall be controlled, and the amount of the target menaquinone shall not be estimated from the weight of fermented material. Process diagrams, fractionation records, and acceptance test results shall serve as verification documentation.
3. Testing—Verification of Separation Capability
A method capable of distinguishing phylloquinone, individual menaquinones, and interfering components shall be adopted according to the analytes. Where derivatization or reduction is performed before detection, the operating conditions and measurement response shall be verified. The lot and sampling method of the product submitted for third-party testing shall be recorded, and the scope of what can be identified in the certificate of analysis shall be disclosed. The institution, test method, and inquiry channel shall also be stated.
4. Labeling Requirements—Breakdown of the Total Amount
Content shall be expressed as the amount of vitamin K corresponding to the recommended daily intake. A calculation sheet shall be used to verify how any amounts of K1, K2, or individual MK homologues shown alongside the total correspond to that total. The amount of a carrier-containing preparation added shall be treated separately, and the designation “K2” alone shall not be regarded as indicating the content of a specific homologue. The forms included in the labeled amount shall be checked against the applicable domestic calculation documentation.
5. Quality Requirements—Light Protection and State in the Product
The remaining amount of each homologue and changes in related peaks shall be examined with consideration of light exposure during processing, storage containers, and light exposure at the point of sale. For emulsified products, the amount sampled after phase separation shall also be verified. Light-protection specifications, handling after opening, and storage conditions shall correspond to packaging test results. The business operator shall establish specifications used to determine shelf life and shall present the supporting test evidence.
6. Precautions for Intake
Official cautionary information on vitamin K use while taking medication shall be reviewed, and persons using anticoagulants shall be advised to consult a physician before use. Allergen information arising from culture media or carriers in fermented raw materials shall be verified for the final formulation. Cautionary statements shall be included among the review items for raw material changes, and draft labeling shall be checked to ensure that these statements can be consulted on both the sales page and the container.
7. Documentation Management
The MK designation shall be used as a search field in the documentation index, and records of extracted fractions, reference standards, separation conditions, and label versions shall be retained. The sections consulted in [documentation on vitamin K classification and precautions](https://ods.od.nih.gov/factsheets/VitaminK-HealthProfessional/) and the date of verification shall be registered. When the test method is changed, it shall be recorded whether the components included in the total differ between the old and new methods, and the business operator shall specify the retention period.
Article 5 (Evaluation Categories)
- Conformity: All items are satisfied, and the homologues used, their inclusion in the total amount, and documentation on precautions when taking medication are consistent.
- Partial conformity: There are no gaps in the evidence supporting the homologues and labeled amounts, and procedures are established for remedying deficiencies in the organization of publicly disclosed documentation.
- Nonconformity: The MK designation cannot be verified, the amount of a specific homologue is labeled on the basis of unresolved signals, or required labeling advising consultation is absent.
Article 6 (Implementation)
A self-declaration of conformity shall be made with explicit identification of the homologues and raw material preparation methods covered. In response to an application, the Council shall verify the correspondence between separation test results and the label. Changes to fermentation conditions or fractionation ranges, or the addition of homologues, shall trigger a review that includes analysis and cautionary information.
Supplementary Provisions
The effective date shall be 7 September 2026. The Council shall address interpretations concerning the manner of describing homologues on the basis of the documentation presented.
※ This Standard sets out evaluation criteria for information disclosure and quality management practices and does not guarantee the efficacy or safety of individual products.