HMB Quality and Labeling Standard
JHFC-S-038 Enacted: 7 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: 7 September 2026 / Effective: the same day
Preamble (Rationale for Enactment)
HMB is handled in forms such as the free acid and calcium salt, and the same raw material weight does not represent the same amount expressed as HMB. When hydration, diluents, and carriers for granulation also contribute to the weight, the correspondence between commercial specifications and packaging labels becomes less clear. This Standard is established to distinguish HMB itself, counterions, and formulation constituents so that documentation can be verified on the same calculation basis even when the chemical form changes.
Article 1 (Purpose)
Labeling based on compound identification and mass balance for HMB shall be established, and conversions between the free acid, salts, and raw material preparations shall be evaluated. Requirements specific to each form of HMB supplement the five criteria of JHFC-A-001 concerning entity identification, manufacturing control, third-party testing, content labeling, and registration information.
Article 2 (Scope)
This document applies to HMB free acid, its salts, and foods formulated with them, for which the conditions for use as food have been confirmed. It includes liquid raw materials, powders, granules, tablets, and capsules. It excludes uses in which leucine, keto acids, or other distinct substances are converted to HMB amounts for labeling. Derivatives such as esters shall be identified separately from the free acid or salts covered by this document.
Article 3 (Terms and Definitions)
- 1. HMB: β-Hydroxy-β-methylbutyric acid, with the chemical name 3-hydroxy-3-methylbutanoic acid.
- 2. Free acid equivalent amount: A value expressing HMB as the mass of the free acid, excluding counterions, water of crystallization, diluting solvents, and carriers.
- 3. HMB salt composition: Information indicating the combination of the HMB moiety, counterions such as calcium, and water of crystallization.
- 4. Formulation carrier: An auxiliary raw material added to an HMB raw material for granulation, coating, or preparation in liquid form.
Article 4 (Requirements)
1. Quality Requirements—Basis for Chemical Form and Purity
The raw material name shall not be registered solely as an abbreviation; the structure, whether it is a free acid or a salt, and hydration state shall be specified. The [reference on HMB chemical nomenclature](https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI%3A37084) shall be cross-checked against reference materials, and related organic acids shall be distinguished. The business operator shall establish specifications for the target substance, residual starting materials, moisture, and by-products and shall present a basis supported by actual measurements.
2. Quality Requirements—Manufacturing Control of Salt Formation and Drying
For the calcium salt, the process from neutralizing agent addition through crystallization, washing, and drying shall be traced, and mother liquor carryover and unreacted materials shall be checked. When drying conditions are changed, the relationship between moisture and counterions shall be examined in addition to the HMB amount. For liquid free acid, the balances during dilution and filling shall be recorded; for granulated products, raw material weights and component amounts before and after carrier addition shall be cross-checked using manufacturing records.
3. Testing—Cross-Checking HMB and Counterion Measurements
A third-party institution shall be commissioned to perform a test capable of directly measuring HMB, and the HMB amount shall not be estimated solely from calcium analysis. For the calcium salt, counterions and moisture shall also be examined, and differences from the theoretical composition shall be evaluated. Extraction recovery shall be validated for formulations containing milk components or similar ingredients. Disclosed results shall include the institution name, method, sample stage, lot, reporting units, and contact point for inquiries.
4. Labeling Requirements—Calculation of the Free Acid Equivalent Amount
HMB in the recommended daily intake shall be labeled as a free acid equivalent amount, and where the raw material used is a salt, its name shall also be stated. The weight of salt added, HMB amount, and elemental calcium amount shall be reviewed as separate items. Conversion shall reflect purity and moisture in the as-received state and exclude formulation carriers. For products with separately added calcium, the combined total with calcium derived from the HMB salt shall be verified against the formulation sheet.
5. Quality Requirements—Storage and Dispensing by Dosage Form
For liquid free acid, contact with the container, leakage, and concentration changes shall be evaluated; for salt powders, moisture absorption and caking shall be evaluated. For coated products, changes in the amount dispensed due to coating damage shall also be recorded. The business operator shall establish storage specifications and shelf life for each type of packaging and shall present their basis. The method of sealing, measuring method, and conditions after opening for liquid products shall be reflected in labeling on the basis of tests using the actual containers.
6. Precautions for Intake
Guidance shall be provided to check the recommended daily intake on the packaging so that the same quantity of a product in a different form is not used on the basis of the HMB salt weight. Where a raw material contains calcium, this fact shall be available for verification during consultation. A statement advising persons undergoing treatment or taking medication to consult a physician shall be included, and where formulation carriers such as milk are used, precautionary information for those raw materials shall also be cross-checked against the evaluation sheet for each formulation.
7. Documentation Management
HMB analysis, calcium analysis, moisture measurement, and calculations for carrier deduction shall be linked to the same incoming lot. Records investigating differences between theoretical composition and measured values shall be retained without reducing them to pass/fail conclusions alone. The business operator shall establish a retention period and, when the hydration state of the raw material is changed, shall check version control records to determine whether previous conversion factors remain in packaging artwork.
Article 5 (Evaluation Categories)
- Conformity: All provisions are met, and HMB identification, counterion balance, carrier deduction, and labeling of the free acid equivalent amount are consistent.
- Partial conformity: The chemical form and quantification documentation are established, and correction deadlines are set for deficiencies limited to matters such as public access to calculation documentation.
- Nonconformity: HMB is quantified solely from calcium values, salt weight is treated as the equivalent amount, or moisture and carriers are counted twice.
Article 6 (Implementation)
The self-declaration of conformity shall present the form of HMB used and the method of conversion to the equivalent amount. The Council shall reverify the conversion using results for the product in the application. The evaluation shall be updated when salt specifications, drying operations, or the concentration of a liquid product change, and raw material designations and labeling units shall be reviewed periodically.
Supplementary Provisions
Implementation of this document shall commence on 7 September 2026. Inquiries concerning HMB amounts shall distinguish between the free acid equivalent amount and salt weight.
※ This Standard sets out evaluation criteria for information disclosure and quality management practices and does not guarantee the efficacy or safety of individual products.