Folate Quality and Labeling Standard
JHFC-S-025 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)
Folate-related raw materials include folic acid, reduced folates, and methylfolate, which differ in salt form, water of crystallization, isomers, stabilizing components, and the basis for conversion for labeling. It is also inappropriate to compare food-derived folates and added folate compounds solely on an equal-weight basis. Furthermore, degradation caused by light, heat, oxygen, and pH, and information for intended users, including persons planning pregnancy, require careful verification of consistency. This Standard is established to clarify identity by form, folate equivalents, stability, and regulatory labeling.
Article 1 (Purpose)
The purpose of this Standard is to evaluate chemical forms, isomers, conversion, manufacturing control, quantification, storage, and precautionary information for each user group for health foods containing folic acid or reduced or methylated folate-related components.
Article 2 (Scope)
This Standard applies to oral products labeled with the content of folic acid as pteroylmonoglutamic acid, reduced folates including methylfolate, and their salts or raw material preparations. Where only total folate in food ingredients is labeled, the scope of extraction and conversion shall be clarified separately.
Article 3 (Terms and Definitions)
- 1. Folic acid: In this Standard, the chemical form identified as pteroylmonoglutamic acid.
- 2. Methylfolate: A reduced folate bearing a methyl group for which the salt form and stereochemical configuration have been specified.
- 3. Folate equivalents: The value expressed as the folate amount subject to labeling on the basis of chemical form, molecular composition, and a conversion basis valid under the regulatory system.
- 4. Isomeric purity: The extent to which the stereoisomer of the reduced folate subject to labeling is distinguished from other isomers.
- 5. Degradation-related substances: Related components formed through the effects of light, heat, oxygen, or pH that are to be distinguished from the amount subject to labeling.
Article 4 (Requirements)
- 1. Raw material specifications shall state whether the material is folic acid, methylfolate, or another form, its full chemical name, salt form, water of crystallization or solvation, stereochemical configuration, origin, and stabilizers. For reduced-form raw materials, the target isomer shall be verified using chromatography with reference standards, chiral identification, or other appropriate documentation. The business operator shall establish purity and degradation-related substance specifications for each form and shall present their basis.
- 2. Where salts or hydrates are converted to folate equivalents, calculation records shall include molecular composition, the proportion of the target isomer, raw material purity, moisture content, and preparation concentration. Where food-derived folates, added folic acid, methylfolate, or other forms are used together, the actual amount from each origin and the conversion adopted shall be distinguished. Units or concepts of equivalence shall be verified against official regulatory documentation applicable at the time of application.
- 3. During raw material dissolution, mixing, granulation, drying, and filling, light exposure, oxygen, temperature, pH, metal ions, and holding time shall be controlled by form. Where trace amounts are incorporated, premixing, adhesion, particle segregation, and sampling locations shall be evaluated, and the resistance of reduced and oxidized forms to processing shall not be assumed to be the same. Upon process changes, the remaining amount of the target form and the isomer composition shall be compared.
- 4. The analytical method shall allow folic acid, methylfolate, other folate forms, and degradation-related substances to be distinguished according to the labeling purpose. Extraction, enzyme treatment, light protection, prevention of oxidation, reference standards, and recovery shall be documented in procedures, and where a total folate method is used, the forms included in the measurement shall be clarified. Third-party certificates of analysis shall state the forms, whether isomers can be distinguished, conversions, and product lots.
- 5. Storage tests shall relate light protection, oxygen permeation, moisture, temperature, and product pH to degradation by form. For liquid products, products used after dissolution, and products opened repeatedly, changes in the target form after preparation or opening shall be verified. The business operator shall establish specifications for folate equivalents and related substances at the end of shelf life and shall present the supporting basis together with packaging specifications.
- 6. Labeled amounts shall correspond to the recommended daily intake or a product unit and shall make it possible to identify the forms used, such as folic acid or methylfolate, and whether conversion to folate equivalents has been applied. Where the product is labeled as a food with nutrient function claims, consistency with the component names covered by the regulatory system, labeled amounts, recommended intake, prescribed wording, and precautions shall be verified. Independently devised form names shall not replace regulatory labeling requirements.
- 7. Precautions for intake shall provide guidance on avoiding excessive intake resulting from duplicate intake from foods containing folate, multivitamins, and other products. Information for persons planning pregnancy, pregnant or breastfeeding persons, and persons undergoing treatment or taking medication shall be consistent with official documentation applicable at the time of application and shall not create the misconception that a food can replace individual diagnosis or treatment. Instructions to discontinue use and seek consultation in the event of adverse changes in physical condition shall be provided.
Article 5 (Evaluation Categories)
- Conformity: Forms such as folic acid and methylfolate, isomers, equivalent conversions, quantification by form, remaining amounts at the end of shelf life, and labeling for intended users are consistent.
- Partial conformity: Forms and equivalents can be verified, but information on isomer separation or documentation on degradation after preparation is insufficient, and a plan for providing the missing information is recorded.
- Nonconformity: Salt weight or raw material preparation weight is treated as the folate amount, methylfolate isomers cannot be identified, or labeling of individual forms is supported solely by a total folate value.
Article 6 (Implementation)
The business operator may issue a self-declaration of conformity on the basis of documentation on forms and isomers, folate equivalent calculations, records of mixing trace amounts, testing by form, and storage documentation. Upon application, the Council may verify traceability from the labeled equivalents to the product lot, target isomer, and raw material lot. Reevaluation shall be conducted when the form, salt, isomer composition, formulation, 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.