B Vitamins Quality and Labeling Standard
JHFC-S-024 Enacted: 6 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: 6 September 2026 / Effective: the same day
Preamble (Rationale for Enactment)
B vitamins are not a single component but encompass multiple vitamins and their respective salts, coenzyme forms, and other forms. Molecular weight, potency conversion, sensitivity to light, heat, and moisture, and analytical conditions differ for each component, and a total amount described as "B vitamins" has no uniform meaning. Interactions and analytical interference may also occur in combination formulations. This Standard is established to ensure that each vitamin is identified, quantified, and labeled individually and to prevent omission of information through the use of a group name.
Article 1 (Purpose)
The purpose of this Standard is to evaluate the consistency of forms by component, potency units, processes for combination formulations, individual quantification, storage, and precautionary labeling for health foods containing two or more B vitamins as "B vitamins" or under a similar designation.
Article 2 (Scope)
This Standard applies to oral products containing multiple nutrients from among thiamine, riboflavin, niacin, pantothenic acid, vitamin B6, biotin, vitamin B12, and other nutrients treated as B vitamins under the regulatory system. JHFC-S-025 shall be used in conjunction with this Standard for matters specific to folate.
Article 3 (Terms and Definitions)
- 1. Table of forms by component: A list correlating the chemical name, salt, coenzyme form, origin, and labeling target for each vitamin.
- 2. Individual potency: The value obtained for each vitamin by converting the adopted chemical form to the nutrient amount under the regulatory system.
- 3. Group labeling: Labeling that collectively designates two or more B vitamins.
- 4. Mutual stability: The effects of vitamins, minerals, moisture, and other components within the same preparation on the remaining amount of each vitamin.
- 5. Separate quantification: Individual measurement of each vitamin or each form subject to labeling, with differentiation from the responses of other components.
Article 4 (Requirements)
- 1. The table of forms by component shall state the common name, chemical name, salt or derivative, origin, raw material preparation concentration, and carrier for each vitamin. Where coenzyme forms or multiple forms are used, reference standards, chromatography, spectroscopic documentation, or other such evidence capable of distinguishing each form shall be available. The designation "B vitamins" alone shall not substitute for verification of identity or purity.
- 2. The labeled amount of each component shall be calculated individually, taking into account the amount of the raw material compound, counterion or bonded moiety, purity, moisture content, and preparation concentration. Where niacin equivalents, other equivalent amount labeling, or potency units are adopted, the target substances and conversion basis shall be recorded for each component. Numerical amounts of different vitamins shall not be added together to give a "B vitamin amount."
- 3. Weighing, premixing, main mixing, granulation, drying, and tableting shall take into account differences in the formulation amounts of individual components, particle size, electrostatic charging, adhesion, and particle segregation. Color or odor alone shall not be used as an indicator of uniformity; multiple representative components with differing formulation amounts shall be selected and verified by sampling location. Carryover from other products shall be controlled through cleaning and changeover records.
- 4. The quantitative method shall specify the extraction solution, enzyme treatment, light protection, pH, reference standards, and detection method for each vitamin and shall evaluate interference from coexisting B vitamin components and degradation products. Where simultaneous analysis is used, recovery, selectivity, and the measurement range shall be validated for each component. Third-party certificates of analysis shall individually state all components tested, their forms, conversions, and product lots.
- 5. The stability plan shall identify, for each formulation, components susceptible to light, components liable to change during thermal processes, and components affected by moisture and pH. Interactions with coexisting redox-active components, minerals, and packaging materials shall be investigated, and each component subject to labeling, in addition to the component most susceptible to change, shall be verified at the end of shelf life. The business operator shall present specifications for each component and the supporting basis for storage.
- 6. Labeling shall state the name of each vitamin included and its amount per recommended daily intake in an individually appropriate unit, and shall not label an amount solely under the group name. For each component covered by labeling as a food with nutrient function claims, the labeled amount, recommended intake, prescribed wording, precautions, and nutrition labeling shall be checked against regulatory requirements applicable at the time of application. Components outside the scope of the regulatory labeling system shall not be grouped together in a manner that implies they are covered by that system.
- 7. Precautionary labeling shall provide guidance on avoiding duplicate intake from similar multivitamin products and excessive intake of each component. Where a particular B vitamin component requires individual verification regarding intended users, concurrent use with medicines, or long-term use, the component shall be identified by name on the basis of official documentation. Instructions to discontinue use and seek consultation in the event of adverse changes in physical condition shall not consist solely of a general statement covering the group as a whole.
Article 5 (Evaluation Categories)
- Conformity: Forms, individual potency, mixing uniformity, separate quantification, mutual stability, and regulatory labeling can be traced for all components included in the formulation.
- Partial conformity: The amounts of the main components can be verified, but information on recovery in simultaneous analysis or documentation at the end of shelf life for particular components is insufficient, and a plan for providing the missing information is in place.
- Nonconformity: Components cannot be identified because only the group name is used, amounts of different vitamins are added together, or test results for only some components are used to support labeling for all components.
Article 6 (Implementation)
The business operator may issue a self-declaration of conformity on the basis of the table of forms by component, individual conversion sheets, mixing uniformity evaluations, test results by component, and mutual stability documentation. Upon application, the Council may verify traceability from each labeled amount to the product lot and each raw material lot. Reevaluation shall be conducted when the constituent components, chemical forms, formulation ratios, process, dosage form, or simultaneous analysis conditions are changed.
Supplementary Provisions
This Standard shall take effect on 6 September 2026.
※ This Standard sets out evaluation criteria for information disclosure and quality management practices and does not guarantee the efficacy or safety of individual products.