Dietary Fiber Quality and Labeling Standard
JHFC-S-020 Enacted: 5 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: 5 September 2026 / Effective: the same day
Preamble (Rationale for Enactment)
Dietary fiber encompasses fractions with differing properties, including soluble and insoluble fractions, high- and low-molecular-weight fractions, and fractions derived from natural sources or from processing. The fractions recovered differ according to the analytical method, and in products containing multiple ingredients, the sum of the certified values for individual raw materials does not necessarily equal the measured value for the final product. Dry weight, carbohydrate quantity, and the amount of fiber raw materials are also distinct from dietary fiber quantity. This Standard is established to clarify the scope of labeling, the suitability of analytical methods, information on individual fractions, and the basis for dietary fiber amounts in products.
Article 1 (Purpose)
The purpose of this Standard is to evaluate raw material origins, definitions of fiber fractions, classifications such as soluble and insoluble fiber, selection of analytical methods, product content, manufacturing and storage control, testing, and cautionary information for health foods labeled with dietary fiber quantities.
Article 2 (Scope)
This Standard applies to one or more dietary fiber raw materials derived from plants, algae, fungi, animals, processed carbohydrates, or other sources, and to oral products labeled with their dietary fiber content. Where a separate component-specific standard exists for an individual component, that standard shall be used in conjunction with this Standard. This Standard addresses labeling of total dietary fiber and its fractions.
Article 3 (Terms and Definitions)
- 1. Total dietary fiber: The amount obtained by summing the individual fiber fractions covered by the adopted analytical method.
- 2. Soluble fraction: Dietary fiber classified on the basis of solubility and recovery conditions in specified analytical operations.
- 3. Insoluble fraction: Dietary fiber recovered as an insoluble residue in specified analytical operations and determined after correction.
- 4. Low-molecular-weight fraction: Dietary fiber with a low degree of polymerization that is not readily recovered by precipitation or similar operations and requires a distinct separation and quantification procedure.
- 5. Fraction consistency: The absence of contradictions in the scope and calculation relationships of total amounts, amounts by fraction, and amounts of individual ingredients.
Article 4 (Requirements)
- 1. For each fiber raw material, the source organism or raw material substance, part used, extraction and processing methods, and supply lot shall be recorded. For composite raw materials, carriers, carbohydrates, proteins, and other nonfiber components shall be distinguished, and dietary fiber content shall not be estimated solely from the raw material name. Precautions relating to origins and processing aids shall be evaluated.
- 2. The scope of dietary fiber covered by labeling shall be defined in relation to soluble, insoluble, low-molecular-weight, and other fractions and the adopted analytical method. Fractions included in and excluded from total amount labeling shall be listed to prevent double counting of the same component. The business operator shall establish specifications for composition by fraction and total amount and shall present the basis for those specifications.
- 3. Analytical methods shall be selected taking into account the molecular size, solubility, and resistance to digestion of the fibers present in the product. Conditions for enzyme treatment, filtration, precipitation, separation and quantification, protein and ash corrections, and calculations shall be documented in the procedure. Where low-molecular-weight fractions or fibers derived from processing are present, the range recoverable by the selected method shall be validated.
- 4. For products containing multiple fiber ingredients, their mutual effects on dissolution, precipitation, and analytical responses shall be verified. Interference from lipids, saccharides, sugar alcohols, proteins, minerals, and thickening components shall be evaluated, and homogenization and recovery shall be validated for each dosage form. Where a simple sum of raw material specification values is treated as the final product value, its validity shall be demonstrated by product testing.
- 5. Labeling shall express dietary fiber quantity by mass corresponding to the recommended daily intake or a product unit and shall clearly state whether it represents the total amount or a specific fraction. Where soluble and insoluble fiber are stated together, the calculation relationship between each measurement target and the total amount shall be maintained. Raw material weight, dry weight, or a carbohydrate value calculated by difference shall not be substituted for dietary fiber quantity. The business operator shall establish labeling specifications and shall present the supporting basis.
- 6. For lot control, verification parameters appropriate to product characteristics shall be selected from raw material acceptance, mixing uniformity, product content, and method-specific correction parameters. Where results are presented as third-party testing, the certificate of analysis shall clarify the method used, measured fractions, whether the sample is a raw material or final product, and the applicable lot. Results obtained by different analytical methods shall not be combined without comparing their scopes.
- 7. Moisture absorption, caking, phase separation, viscosity changes, and hydrolysis during storage shall be observed according to the dosage form, including powder, liquid, or jelly, and the packaging. Handling conditions shall be established for products whose moisture content or state of dispersion changes after opening. Labeling shall state fiber origins, whether the quantity is a total or a fraction, storage methods, recommended intake, product-specific precautions such as those for dosage forms requiring sufficient water, and instructions to discontinue use and seek consultation in the event of abnormalities.
Article 5 (Evaluation Categories)
- Conformity: Raw material origins, fraction definitions, the scope of the analytical method, product recovery, total amounts and amounts by fraction, and labeling are consistent.
- Partial conformity: The total amount can be verified, but recovery documentation for low-molecular-weight fractions or composite ingredients is insufficient, and the method and deadline for providing the missing information are recorded.
- Nonconformity: Raw material weight is treated as dietary fiber quantity, the analytical method cannot recover the target fractions, or the same fraction is counted more than once in the total amount.
Article 6 (Implementation)
The business operator may issue a self-declaration of conformity on the basis of raw material origin registers, fraction lists, documentation on analytical method selection, product recovery tests, lot test results, and storage records. Upon application, the Council may verify traceability from the labeled total amount to individual fractions, product lots, and raw material lots. Reevaluation shall be conducted when the raw material, processing method, fraction composition, formulation, dosage form, or analytical method is changed.
Supplementary Provisions
This Standard shall take effect on 5 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.