Oligosaccharides Quality and Labeling Standard
JHFC-S-018 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)
The term oligosaccharides does not designate a single substance; it encompasses groups of carbohydrates differing in constituent monosaccharides, linkage patterns, and degrees of polymerization. Raw material solids contain monosaccharides, disaccharides, carbohydrates with higher degrees of polymerization, and reaction by-products in addition to the target oligosaccharides, and neither raw material weight nor carbohydrate quantity alone indicates the amount of the target components. Enzymatic reactions, separation and purification, and hydrolysis during storage may also alter the composition. This Standard is established to clarify saccharide chain composition, manufacturing methods, separate quantification of components, and the subject of labeling.
Article 1 (Purpose)
The purpose of this Standard is to evaluate chemical identity, raw material origins, saccharide composition, manufacturing control, quantification of target components, conversions for labeling, testing, storage, and cautionary information for health foods containing oligosaccharides.
Article 2 (Scope)
This Standard applies to oligosaccharide raw materials for which the business operator has defined the constituent monosaccharides, linkage patterns, or range of degrees of polymerization, and to oral products labeled with the content of these oligosaccharides. It does not apply to products in which total carbohydrate quantity, syrup weight, or raw material mixture quantity alone is stated as the amount of target oligosaccharides.
Article 3 (Terms and Definitions)
- 1. Target oligosaccharides: Carbohydrates defined by the business operator as the subject of labeling by name, constituent monosaccharides, principal linkages, and range of degrees of polymerization.
- 2. Saccharide composition profile: Information showing separately the composition of target components, monosaccharides, disaccharides, carbohydrates with higher degrees of polymerization, and other components.
- 3. Degree of polymerization distribution: The distribution of the number of monosaccharide units constituting saccharide chains, as determined under the adopted analytical conditions.
- 4. Reaction-derived components: Saccharides and other substances that remain or are formed in association with enzymatic reactions, hydrolysis, or transfer reactions.
- 5. Solids basis: A calculation basis that distinguishes moisture and expresses composition relative to the solids in a raw material or product.
Article 4 (Requirements)
- 1. Target oligosaccharides shall be defined by their constituent monosaccharides, principal linkage patterns, range of degrees of polymerization, and necessary isomer information. Identity shall be confirmed by combining separation behavior relative to reference standards, enzymatic degradation characteristics, mass information, and other appropriate documentation, without relying solely on common names. The specification shall state the saccharide chains included in the measurement target and the saccharides excluded from it.
- 2. The origin of the carbohydrate substrate and the history of enzyme or catalyst use, reaction, inactivation, decolorization, desalting, concentration, fractionation, and drying shall be linked to lots. The sources of enzymes used, processing aids, and carriers shall be recorded, and allergens from source materials and components that may remain from reaction and purification processes shall be evaluated. When the manufacturing method changes, its effects on saccharide composition shall be compared.
- 3. Composition documentation shall be available for raw materials and products, distinguishing target oligosaccharides, monosaccharides, disaccharides, carbohydrates with higher degrees of polymerization, moisture, and reaction-derived components significant to the manufacturing method. The business operator shall establish specifications for the proportion of target components and variations in composition and shall present the supporting basis. For syrups, powders, and other forms, the solids basis shall not be confused with the basis of the product as-is.
- 4. Quantification methods shall employ conditions capable of separating target saccharide chains from coexisting saccharides, and retention times or detector responses, reference standards, calibration, pretreatment, and recovery rates shall be recorded. Where multiple oligosaccharides are quantified collectively, the components included in the total shall be listed. Where a method by difference is used, the directly measured parameters, uncertainty, and product compositions to which the method is applicable shall be clarified.
- 5. Content labeling shall express the mass of target oligosaccharides in the recommended daily intake or a product unit and shall distinguish it from the amount of the raw material preparation, solids, and carbohydrates. Where multiple types are included, documentation enabling verification of the amount of each type or the composition of the total shall be retained. The business operator shall establish labeling specifications and shall present final product tests and the conversion process as the supporting basis.
- 6. In the final product, analytical interference from other saccharides, sugar alcohols, dietary fiber, flavor components, and excipients shall be examined, and extraction conditions appropriate to the dosage form shall be validated. When disclosing results as third-party testing, the certificate of analysis shall identify whether the sample is a raw material or product, the range of saccharide chains measured, the analytical method, the applicable lot, and the calculation basis for the results.
- 7. Stability verification shall observe hydrolysis, browning, moisture absorption, or crystallization associated with moisture, temperature, acidity or alkalinity, and storage duration for each formulation. Handling periods shall be examined for liquid products and products whose moisture conditions change after opening. Labeling shall consistently state the types of oligosaccharides, the definition of content, storage methods, precautions relating to source materials, and product-specific guidance to avoid excessive use.
Article 5 (Evaluation Categories)
- Conformity: The definition of target saccharide chains, manufacturing origins, saccharide composition, separate quantification of components, product content, and composition during storage are traceable.
- Partial conformity: The amount of target components can be verified, but isomer identification or composition documentation after opening is insufficient, and a plan to provide the missing information is recorded.
- Nonconformity: Raw material weight or total carbohydrate quantity is treated as the amount of target oligosaccharides, or the saccharide chains included in collective quantification cannot be identified.
Article 6 (Implementation)
The business operator may issue a self-declaration of conformity on the basis of target saccharide chain specifications, manufacturing records, saccharide composition profiles, product quantification, and stability documentation. Upon application, the Council may verify traceability from the labeled amount to analytical peaks, product lots, and reaction raw materials. Reevaluation shall be conducted when the substrate, enzyme, reaction conditions, fractionation method, definition of content, 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.