Glucosamine Quality and Labeling Standard
JHFC-S-010 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)
Glucosamine raw materials include those originating from chitin from crustaceans and other organisms and those produced by fermentation or other processes, and are traded in chemical forms such as the hydrochloride and sulfate. The weight of a compound including its salt components is not equivalent to the amount of glucosamine itself, and the sulfate may also be accompanied by stabilizing salts. Origin is also relevant to allergen control. This Standard is established to distinguish and evaluate stereochemistry, salt form, production origin, converted content, and process residues.
Article 1 (Purpose)
The purpose of this Standard is to evaluate chemical identity and stereochemistry, raw material origin, salt form and formulation form, glucosamine-equivalent amount, stability, testing according to origin and process, and cautionary statements for health foods containing glucosamine.
Article 2 (Scope)
This Standard applies to D-glucosamine, its salts, and powders, tablets, capsules, granules, liquids, and other oral products containing them. N-acetylglucosamine, polymers containing glucosamine as a constituent unit, and other amino sugars shall not be included in the total glucosamine content.
Article 3 (Terms and Definitions)
- 1. Glucosamine: The free-form amino sugar having the stereochemistry specified in this Standard.
- 2. Salt form: A chemical form of glucosamine with a counterion, such as the hydrochloride or sulfate.
- 3. Glucosamine-equivalent amount: The amount determined as the equivalent of free-form glucosamine from a weight that includes salts, water of crystallization, or stabilizing salts.
- 4. Chitin-derived: A production origin in which the material is obtained by hydrolyzing chitin from crustaceans, fungi, or other organisms.
- 5. Fermentation-derived: An origin in which glucosamine or its precursor is obtained with microbial cultivation as the principal production step.
Article 4 (Requirements)
- 1. Identity shall be determined by combining a method that separates glucosamine from other amino sugars with optical activity, spectroscopic information, or appropriate structural confirmation. The raw material specification shall state the designation of the D-form, salt form, counterions, water of crystallization, and the presence or absence of stabilizing salts. Glucosamine shall not be identified solely by a non-selective amino group reaction.
- 2. For chitin-derived materials, the species, part used or source tissue, collection or aquaculture area, steps for producing chitin and chitosan, and hydrolysis steps shall be recorded. For fermentation-derived materials, the microorganism used, principal culture medium ingredients, production and recovery steps, and refining steps shall be specified. Where origin terms such as plant-based are used, their scope shall be defined to include the actual carbon source, culture medium, and processing aids, and shall be supported by supply documentation.
- 3. Hydrochloride, sulfate, and other salt forms shall be distinguished. For the sulfate, stoichiometry and analytes shall be specified, including coexisting inorganic salts used to maintain the composition. The free form, salt form, and raw material preparation weight shall be controlled separately, and the raw material name shall match the form confirmed by testing. Confirmation of chloride, sulfate ions, or counterions shall be incorporated into the identity documentation.
- 4. Content shall be stated in units of mass per recommended daily intake, clearly specifying whether it represents the compound amount including the salt components or the free-form glucosamine-equivalent amount. Conversion shall reflect salt form, purity, moisture, and stabilizing salts, and the formula and values used shall be retained. Where multiple salt forms are included in the formulation, the measured value for each shall be converted to the same basis. Declared values and specifications shall be established by the business operator together with their basis.
- 5. The quantitative method for the final product shall evaluate interference from other amino sugars, sugars, amino acids, chondroitin-containing raw materials, and other substances, and shall measure glucosamine selectively. Where derivatization or hydrolysis is used, glucosamine newly generated from polymers in the product by the analytical procedure shall be distinguished, and constituent units outside the scope of the declared content shall not be included in that content.
- 6. Stability evaluation shall observe, for each dosage form, coloration, degradation, or content changes associated with moisture, temperature, light, liquid properties, and coexistence with reducing sugars or other substances. For hygroscopic powders, liquid products, or combination formulations, caking, precipitation, and uniform sampling after opening shall also be examined. The business operator shall establish control specifications corresponding to the packaging specifications and storage conditions on the basis of test results.
- 7. Testing shall include identity, salt form, glucosamine quantification, moisture, and other relevant items. For crustacean-derived materials, control of source proteins and other allergens, and contaminants associated with marine raw materials, shall be evaluated. For fermentation-derived materials, microorganisms and substances originating from the culture medium and refining steps shall be evaluated. Residues to be tested shall be selected according to acid or alkali hydrolysis, solvent use, and other processing steps, and reasons for exclusions and the basis for specifications shall be recorded.
- 8. Labeling shall consistently state the glucosamine salt form, origin category, whether the content is expressed as compound amount or equivalent amount, and storage instructions. For crustacean-derived materials, the organism used and allergen information shall be appropriately reflected in ingredient labeling and the caution section. Advice to seek consultation for persons using medicinal products, pregnant or breastfeeding persons, or persons under medical supervision, and instructions to discontinue use in the event of adverse symptoms, shall be established on the basis of the latest official information and product-specific evaluation.
Article 5 (Evaluation Categories)
- Conformity: Glucosamine stereochemistry, salt form, production origin, converted content, selective quantification, and testing according to origin are consistent with the labeling.
- Partial conformity: Salt form and actual content can be confirmed, but origin documentation for the culture medium or species, or evaluation after opening, is insufficient, and a plan to address the deficiencies is in place.
- Nonconformity: Salt weight is treated as glucosamine content without an explanation of conversion, the amount generated by hydrolysis of polymers is included, or allergen control appropriate to the origin is not performed.
Article 6 (Implementation)
The business operator may issue a self-declaration of conformity on the basis of origin documentation, chemical form specifications, conversion tables, product tests demonstrating selectivity, and stability documentation. Upon application, the Council may verify traceability from the declared amount to the salt form, reference substances, source organism, or fermentation lot. Reevaluation shall be conducted when the species, culture medium, hydrolysis method, salt form, 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.