Chondroitin Quality and Labeling Standard
JHFC-S-011 Enacted: 3 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: 3 September 2026 / Effective: the same day
Preamble (Rationale for Enactment)
Raw materials containing chondroitin include those obtained from animal tissues, those produced using fermentation processes, and those involving chemical modification. Their analytical properties differ according to sulfation position, molecular weight distribution, counterions, and coexisting carbohydrate chains. The weight of a crude extract, the amount of chondroitin sulfate salts, and the chondroitin-equivalent amount are not identical. In addition, colorimetric reactions alone do not readily distinguish other acidic polysaccharides. This Standard is established to enable verification of carbohydrate chain identity, origin, sulfation composition, and declared amounts through lot documentation.
Article 1 (Purpose)
The purpose of this Standard is to evaluate the appropriateness of raw material origin, structural identity, molecular weight and sulfation control, content labeling, manufacturing and testing, storage, and cautionary information for health foods formulated with chondroitin or chondroitin sulfate salts.
Article 2 (Scope)
This Standard applies to chondroitin sulfate isolated and purified from animal tissues or other specified origins, its sodium and other salts, and oral products using these materials. Powders of source tissues, mucopolysaccharide mixtures, or other glycosaminoglycans shall not be included in the total chondroitin amount without supporting evidence.
Article 3 (Terms and Definitions)
- 1. Chondroitin sulfate: A carbohydrate chain bearing sulfate groups and having glucuronic acid and N-acetylgalactosamine as its principal repeating structure.
- 2. Sulfation composition: The positions at which sulfate groups are attached and the composition of disaccharide units, including nonsulfated units.
- 3. Molecular weight distribution: Information indicating the range of molecular sizes within a population of carbohydrate chains, as determined by the measurement method used.
- 4. Counterion: Sodium or another ion that forms a salt with chondroitin sulfate.
- 5. Chondroitin-equivalent amount: The amount calculated or measured as a defined chondroitin moiety, distinguishing salt components, moisture, and coexisting substances.
Article 4 (Requirements)
- 1. Raw material identity shall be confirmed by combining information on constituent monosaccharides, disaccharide profiles after enzymatic digestion, and molecular size. Identity shall not be determined solely by a single color reaction or measurement of total acidic polysaccharides, and the ability to distinguish hyaluronic acid, dermatan sulfate, and other potentially coexisting polysaccharides shall be demonstrated. Lot identifiers for reference materials, enzymes, and materials used for assessment shall be linked to the test records.
- 2. For materials of animal origin, the species, tissues used, country of collection, raw material treatment, and processing through purification shall be recorded. Where multiple species or tissues are mixed, each mixing unit shall be traceable. Where materials are labeled as being of non-animal or fermentation origin, carbohydrate chain production, sulfation, and purification shall be distinguished as separate steps, and the scope of the origin claim, including culture substrates and processing aids, shall be defined in the specification.
- 3. The business operator shall establish specifications for sulfation composition, molecular weight distribution, counterions, moisture, and coexisting glycosaminoglycans according to the intended use and production method of the raw material, and shall present the basis for those specifications. The relationship between the specifications and process conditions for deproteinization, hydrolysis, precipitation, membrane separation, and other steps shall be recorded. Materials with reduced molecular weight shall be distinguished from untreated materials.
- 4. Content shall be expressed in units of mass corresponding to the recommended daily intake, clearly stating whether it represents the amount of chondroitin sulfate salts, the chondroitin-equivalent amount, or the amount of the raw material mixture. Raw material weight that includes counterions, moisture, carriers, and proteins shall not be treated as the amount subject to labeling. The conversion formula, the distinction between measured and calculated values, and the basis for the labeling specifications established by the business operator shall be retained.
- 5. Product testing shall evaluate interference from sugars, proteins, glucosamine, and other polysaccharides, and shall check for loss or degradation of carbohydrate chains during sample preparation. Where enzymatic digestion is used, enzyme selectivity and successful completion of the reaction shall be verified for each product dosage form. Where separation analysis is used, identification and recovery of the target disaccharides shall be verified for each product dosage form.
- 6. Lot testing shall include those items among identity, the amount subject to labeling, sulfation composition, and molecular weight distribution that distinguish the product's characteristics. Test targets shall be selected through risk assessment from proteins, microorganisms, and environmental substances originating from animal tissues, and residues originating from purification processes. For third-party testing, the sample stage, scope of testing, and correspondence to the product lot shall be clarified in the certificate of analysis.
- 7. Storage evaluation shall observe the effects of temperature, humidity, liquid properties, and formulation ingredients on carbohydrate chain degradation, moisture absorption, caking, or precipitation. The business operator shall establish storage specifications according to the dosage form, such as powders or liquids, and the packaging, and shall present their basis. Labeling shall consistently state the source organism, salt form, definition of content, storage instructions, cautions concerning source materials, and instructions to discontinue use and seek consultation in the event of adverse symptoms.
Article 5 (Evaluation Categories)
- Conformity: The source organism and tissue, carbohydrate chain identity, sulfation composition, molecular weight, converted content, and lot testing are mutually traceable and traceable to the labeling.
- Partial conformity: Identity and the declared amount can be confirmed, but molecular weight documentation or part of the origin-related process documentation is insufficient, and the information to be supplemented and the deadline are recorded.
- Nonconformity: Total acidic polysaccharide content is declared without identification, raw material mixture weight is treated as the chondroitin amount, or the source organism and tissue cannot be traced.
Article 6 (Implementation)
The business operator may issue a self-declaration of conformity on the basis of origin registers, carbohydrate chain identification documentation, sulfation and molecular weight specifications, product quantification, and test results. Upon application, the Council may verify traceability from the declared amount to the analyte, purification lot, and source tissue. Reevaluation shall be conducted when the species, tissue, purification method, molecular weight adjustment, counterion, dosage form, or analytical method is changed.
Supplementary Provisions
This Standard shall take effect on 3 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.