Resistant Dextrin Quality and Labeling Standard
JHFC-S-019 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)
Resistant dextrin is a carbohydrate fraction obtained through starch degradation, heat treatment, and purification, and its saccharide chain distribution varies with the source plant, reaction conditions, and fractionation method. Total dextrin, water-soluble solids, and the digestion-resistant fraction measured by an official or validated method are not equivalent. Other carbohydrates and dietary fibers in a product may also affect measured values. This Standard is established to align traceability of starch origins, the measurement definition of digestion resistance, recovery from products, and labeled amounts.
Article 1 (Purpose)
The purpose of this Standard is to evaluate the validity of source starch, processing and fractionation steps, verification of structure and digestion resistance, content measurement, labeling, testing, storage, and cautionary information for health foods containing resistant dextrin.
Article 2 (Scope)
This Standard applies to dextrin raw materials manufactured from explicitly identified starch and for which the digestion-resistant fraction is defined by the adopted digestion and quantification methods, and to oral products made from these raw materials. Ordinary dextrin, unprocessed starch, or other dietary fibers shall not be included in the amount of resistant dextrin without supporting grounds.
Article 3 (Terms and Definitions)
- 1. Source starch: The plant species and its starch raw material used to manufacture resistant dextrin.
- 2. Digestion-resistant fraction: The fraction that remains undigested under specified enzymatic digestion and separation and quantification conditions and is recovered as the measurement target.
- 3. Digestion test system: A series of analytical procedures comprising the enzymes used, reaction conditions, separation operations, and quantification.
- 4. Low-molecular-weight saccharide fraction: Monosaccharides, disaccharides, and other saccharides with low degrees of polymerization that coexist as a result of manufacturing or storage.
- 5. Product recovery rate: The proportion of the target fraction that can be recovered during pretreatment and analysis of the final product.
Article 4 (Requirements)
- 1. For source starch, the plant species, plant part used as raw material, procurement unit, and relationship to manufacturing lots shall be recorded. Where multiple sources are used, the extent of blending and controls for switching sources shall be stated. The identity and acceptance characteristics of the raw material starch shall be cross-checked using supplier documentation and verification methods established by the business operator and shall be consistent with the labeled origin.
- 2. Each step of roasting or heating, acid or enzyme treatment, hydrolysis, purification, desalting, fractionation, concentration, and drying shall be linked to lot records. The effects of process conditions on saccharide chain distribution, low-molecular-weight saccharides, and the digestion-resistant fraction shall be evaluated. Control parameters appropriate to the manufacturing method shall be established for residues of catalysts, processing aids, and purification materials.
- 3. Raw material identity shall be confirmed by combining parameters appropriate to the manufacturing method, selected from saccharide chain or molecular size distribution, solubility, low-molecular-weight saccharide composition, and results of the adopted measurement of digestion resistance. Assessment shall not be based solely on total dextrin or solids. The business operator shall establish specifications for the target fraction, coexisting saccharides, and moisture and shall present the supporting basis.
- 4. For measurement of the digestion-resistant fraction, an official or validated method shall be selected, and enzyme types and activity control, reaction conditions, precipitation or separation operations, corrections, reference materials, and calculation formulas shall be recorded. Where analytical methods target different fractions, results shall not be converted unconditionally, and their correspondence with the method adopted for labeling shall be clearly stated.
- 5. In the final product, the effects of digestible dextrin, saccharides, proteins, lipids, and other soluble or insoluble dietary fibers on the results shall be evaluated. Homogenization, defatting, extraction, and product recovery rates shall be validated for each dosage form, including liquids, powders, and tablets. Where calculation by difference is used, the measured parameters and limitations of applicability shall be stated.
- 6. The labeled amount shall be expressed as the amount of resistant dextrin corresponding to the recommended daily intake or a product unit and shall be distinguished from the amount of the raw material preparation and total dietary fiber. The business operator shall establish labeling specifications and shall present actual final product measurements, product recovery, and lot variation as the supporting basis. Disclosure of third-party testing shall identify the analytical method, sample stage, target fraction, and lot.
- 7. Storage evaluation shall verify hydrolysis, moisture absorption, caking, precipitation, or color changes associated with temperature, humidity, acidity or alkalinity, and reactions with other components. Quality indicators shall be established according to packaging and conditions after opening. Labeling shall state the source, definition of the measurement target, storage methods, precautions relating to raw material origins, instructions to follow the recommended intake for the product, and guidance to seek consultation in the event of abnormalities.
Article 5 (Evaluation Categories)
- Conformity: Source starch, processing and fractionation, the digestion resistance test system, product recovery, and labeled amounts are linked on a lot-by-lot basis.
- Partial conformity: The raw material and labeled amount can be verified, but supplementary information is required on the effects of coexisting fibers or dosage-form-specific recovery, and the measures to address this are recorded.
- Nonconformity: Total dextrin is stated as the digestion-resistant fraction, the analytical method cannot be identified, or other dietary fibers are included in the total without differentiation.
Article 6 (Implementation)
The business operator may issue a self-declaration of conformity on the basis of source registers, processing and fractionation records, digestion resistance test procedures, validation of product recovery, and storage documentation. Upon application, the Council may verify traceability from the labeled amount to analytical calculations, product lots, and source starch. Reevaluation shall be conducted when the source, reaction conditions, purification method, measurement method, formulation, or dosage form 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.