Vitamin D Quality and Labeling Standard
JHFC-S-022 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)
Vitamin D consists primarily of vitamin D2 and vitamin D3, which differ in origin, chemical form, and the concentration of raw material preparations. Because vitamin D is incorporated in trace amounts, errors in mixing uniformity and unit conversion directly affect labeled values, and isomerization or degradation caused by light, oxygen, and heat also requires control. This Standard is established to evaluate, as an integrated whole, the distinction between D2 and D3, the relationship between mass and international units, processes for incorporating trace amounts, and information on avoiding excessive intake.
Article 1 (Purpose)
The purpose of this Standard is to evaluate the consistency of supply forms and origins, potency conversion, premix control, uniformity within the product, quantification that distinguishes degradation products, storage, and labeling for health foods containing vitamin D.
Article 2 (Scope)
This Standard applies to oral products made with ergocalciferol (vitamin D2), cholecalciferol (vitamin D3), or raw material preparations containing these substances. Products that treat active-form pharmaceutical ingredients as equivalent to vitamin D for food use are excluded.
Article 3 (Terms and Definitions)
- 1. Vitamin D2: The form identified as ergocalciferol.
- 2. Vitamin D3: The form identified as cholecalciferol.
- 3. Potency unit: The measurement basis adopted to express the amount of vitamin D by mass or in international units.
- 4. Premix: A raw material preparation mixed in advance with carriers or similar materials to disperse a trace component uniformly throughout a product.
- 5. Isomerization products: Related compounds formed by light, heat, or other factors that are to be distinguished from the vitamin D subject to labeling.
Article 4 (Requirements)
- 1. Raw material specifications shall state whether the material is D2 or D3, its chemical name, source organism or synthetic process, extraction and purification methods, carriers, fats and oils, and stabilizers. The form shall be verified using chromatography, spectra, or other identification documentation, and where a mixture of D2 and D3 is anticipated, results distinguishing the two shall be presented. The business operator shall establish purity and related substance specifications for each form and shall present their basis.
- 2. Where mass and international units are stated together or converted, the applicable D2 or D3 form, potency of the raw material preparation, conversion factor, unit symbols, and rounding method shall be controlled through approved calculation sheets. Raw material weight, premix weight, and the actual amount of vitamin D shall be entered in separate fields, and the units used in labeling, formulation instructions, and certificates of analysis shall be cross-checked. The conversion basis shall be verified against official documentation applicable at the time of application.
- 3. In processes for incorporating trace amounts, premix identification, weighing verification, order of addition, mixing time, adhering residues, and the effects of particle segregation shall be evaluated for each product dosage form. Uniformity shall be validated using samples taken from multiple locations in the mixture, and sedimentation, precipitation, and adsorption onto containers shall be checked for liquid or oil-based products. Uniformity shall be reverified upon reprocessing or a change in scale.
- 4. The quantitative method shall distinguish D2 from D3 and shall use conditions that allow separation from isomerization products and coexisting sterols as necessary. Extraction, whether saponification is performed, internal standards, prevention of light exposure, recovery, and the measurement range shall be documented in procedures. Third-party certificates of analysis shall state the forms measured, conversion to labeling units, final product lot, and locations from which test samples were taken.
- 5. Degradation or isomerization caused by light, heat, oxygen, and moisture shall be evaluated at each stage of raw material storage, mixing, drying, packaging, and distribution. Light protection, oxygen within the container, and the oxidation state of fats and oils shall be related to product specifications, and the amount of each form shall be verified at the end of shelf life. The business operator shall establish potency specifications during storage and shall present time-course documentation for the actual product.
- 6. Content shall correspond to the recommended daily intake or a product unit, and where mass, international units, or both are used, consistency between them shall be maintained. It shall be possible to verify whether D2, D3, or both are used. Where the product is labeled as a food with nutrient function claims, records shall be maintained of verification of the labeled amount, recommended intake, wording prescribed by the regulatory system, and precautions against the laws, regulations, and notices applicable at the time of application.
- 7. Precautions for intake shall clearly provide guidance on avoiding duplicate intake from multiple products containing vitamin D. The business operator shall establish information on excessive intake and guidance for persons undergoing treatment or taking medication, pregnant or breastfeeding persons, children, and other relevant users, taking into account official documentation and the intended users of the product. Instructions to discontinue use in the event of adverse changes in physical condition and methods of consulting a professional shall be stated on the label.
Article 5 (Evaluation Categories)
- Conformity: Identification of D2 and D3, potency conversion, mixing of trace amounts, separate quantification, amounts at the end of shelf life, and regulatory labeling are consistent for the same lot.
- Partial conformity: Forms and content can be verified, but information on uniformity by sampling location or evaluation of isomerization products is insufficient, and a plan for providing the missing information is in place.
- Nonconformity: D2 and D3 cannot be identified, premix weight is treated as the actual amount of vitamin D, unit conversion cannot be traced, or labeling is supported solely by the potency added during manufacture.
Article 6 (Implementation)
The business operator may issue a self-declaration of conformity on the basis of documentation on forms and origins, potency calculation sheets, mixing uniformity records, product testing, and documentation on stability to light and heat. Upon application, the Council may verify traceability from the labeling units to the product lot, premix, and D2 and D3 raw materials. Reevaluation shall be conducted when the origin, form, potency, carrier, process, packaging, or analytical method is 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.