Multivitamin and Mineral (Combination) Quality and Labeling Standard
JHFC-S-033 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)
In products combining vitamins and minerals, the same nutrient may enter the formulation through multiple sources, including dedicated raw materials, premixes, and food ingredients. Furthermore, where separate dosage units are packaged together, manufacturing lots and intake units do not correspond on a one-to-one basis. Merely compiling raw material test results cannot verify the formulation of the entire product, the amounts remaining after mixing, or the correctness of the combination. A standard is therefore established to verify the formulation as a whole.
Article 1 (Purpose)
Requirements for individual components shall be integrated into the formulation, manufacturing, packaging, and labeling of combination products to prevent double counting and gaps in testing. The five criteria of JHFC-A-001 shall serve as common requirements, and specific provisions of the corresponding component-specific standards shall also be recorded in the formulation composition table and applied.
Article 2 (Scope)
This Standard applies to health foods for oral consumption containing both vitamins and minerals. It includes mixtures within a single dosage unit, layered dosage forms, and combinations sold as separate sachets or separate dosage units. Products containing only vitamins or only minerals are outside the scope of this document, and the formulations covered shall be listed for each product.
Article 3 (Terms and Definitions)
- 1. Formulation composition table: A table mapping all nutrients to their contributions from each raw material, chemical forms, and product units.
- 2. Overlapping addition: Addition of the same nutrient to a product through multiple raw material pathways.
- 3. Combination unit: The combination of product components constituting the recommended daily intake, including separate dosage units or sachets.
- 4. Testing coverage table: A list assigning product tests, measurement methods, and supporting documentation to each labeled component.
- 5. Formulation overage: The additional portion included in a formulation as part of label claim planning to allow for changes during storage and similar factors.
Article 4 (Requirements)
1. Quality Requirements—Cross-Checking Constituent Raw Materials
The composition of premixes shall be obtained for each nutrient, and the form, concentration, carrier, and other coexisting nutrients shall be registered. Contributions from dedicated raw materials and food ingredients shall be cross-checked in the formulation composition table, and identity and purity shall be verified against the respective specifications and certificates of analysis. Unknown details shall not be filled in with aggregate values, and the business operator shall present specifications for each raw material and the basis for its selection.
2. Quality Requirements—Mixing and Combination Packaging
The reasons for adopting premixing, granulation, or layering shall be recorded with consideration of differences in formulation amounts, particle sizes, and densities. Indicators shall be selected from both minor and major components, and nonuniformity shall be checked by filling position and time period. For products comprising separate dosage units, the packaging process shall check for mix-ups between unit types and for missing units, and packaging records shall retain the correspondence between each manufacturing lot and the combination units into which it was incorporated.
3. Testing—Coverage of Individual Components
The testing coverage table shall be used to establish a plan for verifying the amounts of all labeled components in the final product. Simultaneous analysis shall verify recovery and selectivity for each component and evaluate interference from coexisting metals and pigments. The components covered by third-party certificates of analysis, methods, sample stages, institutions, and lots shall be disclosed, and untested components shall not be represented as having been tested. A contact point for inquiries about the originals shall also be provided.
4. Labeling Requirements—Calculation of Daily Amounts
The amount of each nutrient per recommended daily intake shall be stated in appropriate units, and no total nutrient amount shall be established by adding together the masses of different components. Products comprising separate dosage units or sachets shall clearly state the types and quantities constituting one day's intake. Contributions of the same component from different raw materials shall be totaled without double counting, and consistency with the packaging unit, composition table, and [reference on nutrition labeling](https://www.caa.go.jp/policies/policy/food_labeling/nutrient_declearation/) shall be verified.
5. Quality Requirements—Stability After Formulation
Contact between metals and vitamins, moisture absorption, and acid–base conditions within the dosage form shall be evaluated across the entire formulation. Where a formulation overage is used, the reason for each component and verification results at formulation and at the end of shelf life shall be recorded, and an overage percentage for another component shall not be transferred. The business operator shall establish specifications for each component and present their basis. Whether all constituent products can be managed under common storage conditions shall be examined and reflected in storage labeling.
6. Precautions for Intake
Cautionary information for the constituent components shall be cross-checked and organized without omitting statements that differ in their target users or conditions for combined use. Guidance shall be provided to check the composition table for overlapping intake from other single-component products. Cautionary statements shall also take into account situations in which only some of the separate sachets are used additionally and shall be cross-checked against the combination unit. Persons undergoing treatment or taking medication shall be advised to consult a physician.
7. Documentation Management
A common formulation version shall be assigned to the formulation composition table, testing coverage table, and packaging lot correspondence table. When a premix is revised, all components it contains shall be recalculated, and the impact on packaging for the previous version shall also be recorded. The versions of the component-specific standards referenced, calculations of contributions from each raw material, and outstanding verification items shall be retained so that they can be reconstructed from the combination unit throughout the retention period established by the business operator.
Article 5 (Evaluation Categories)
- Conformity: All requirements are fulfilled, all labeled components and constituent products are covered, and overlapping additions and packaging consistency can be verified.
- Partial conformity: The identity, amount, cautionary statements, and combination of all components have been verified, and only deficiencies such as documentation indexes remain to be supplemented by a specified deadline.
- Nonconformity: A premix with an unknown composition is included in calculations, results for some components are extended to the whole, or lot correspondence for separate dosage units is lost.
Article 6 (Implementation)
A self-declaration of conformity shall be prepared for each formulation version and combination unit. At the time of application, the Council shall cross-check labeled components against contributions from each raw material and product testing. The overall evaluation shall be reviewed when a constituent component is added, dosage unit types are consolidated, or a premix is revised.
Supplementary Provisions
This Standard shall take effect on 7 September 2026. Inquiries concerning combination formulations shall clearly specify the formulation version concerned.
※ This Standard sets out evaluation criteria for information disclosure and quality management practices and does not guarantee the efficacy or safety of individual products.