Glycine Quality and Labeling Standard
JHFC-S-040 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)
Glycine is added as an individual amino acid and is also present as a constituent of proteins and peptides. The total amount obtained by hydrolyzing a product and the amount initially present in free form represent different analytes. Confusing descriptions of metal compounds and crystalline states also obscures the actual nature of a raw material. A Quality and Labeling Standard is established to distinguish structure, bonding state, and the amount that can be dispensed from the product.
Article 1 (Purpose)
This Standard requires raw material identification consistent with the structural characteristics of glycine and specifies testing and labeling that do not confuse free amounts with bound components. The five criteria of JHFC-A-001 shall serve as common requirements, supplemented by analysis and storage verification for formulations containing sugars or proteins.
Article 2 (Scope)
This Standard applies to powders, granules, tablets, beverages, and formed foods that use free glycine as a raw material or label its content. It excludes evaluation solely of bound glycine contained in collagen or similar materials. Metal raw materials in which glycine serves as a ligand shall be distinguished from the free form; where free glycine is also used, that portion shall fall within the scope of this document.
Article 3 (Terms and Definitions)
- 1. Glycine: Aminoacetic acid. It has no asymmetric carbon atom, and no raw material distinction between L- and D-forms shall be established.
- 2. Bound glycine: Glycine present as constituent residues of proteins or peptides.
- 3. Free-form extraction value: The measured value of extracted glycine obtained without a step that breaks down bound components.
- 4. Crystalline state: Physical property information concerning the crystal form, particle shape, and particle size of a powder raw material.
Article 4 (Requirements)
1. Quality Requirements—Structure and Raw Material Purity
The [structural definition of glycine](https://www.ebi.ac.uk/chebi/CHEBI%3A15428) shall be consulted, and identity shall be confirmed by comparison with reference materials. Neither the proportion of the L-form nor optical rotation shall be used as a basis for determining glycine purity. Related organic substances, residual salts, and moisture shall be selected as specification items according to the production route, such as synthesis or fermentation, and the business operator shall present the specifications and their basis. The presence of metal compounds in the material shall also be checked using elemental analysis or other methods.
2. Quality Requirements—Manufacturing Control of Crystallization and Powders
Carryover of residues contained in the mother liquor shall be checked using crystallization, washing, and drying records. When milling or granulation is performed, the crystalline state and bulk density shall be examined, and their effects on ease of measurement shall be evaluated. When mixing with sugars, material remaining in equipment and particle segregation shall be checked, and the mass balance and sampling tests from raw material feeding through filling shall be included in lot records.
3. Testing—Verification of Free-Form Extraction
Before third-party quantification, sample preparation that does not hydrolyze coexisting collagen or peptides shall be validated for the product formulation. Spike recovery with addition before and after extraction and separation from other amino acids shall be verified, and the nitrogen value of the entire sample shall not be used as a substitute. The institution name, test method, whether the sample is a raw material or a final product, relevant lot, and contact point for inquiries shall be disclosed. Where total amount analysis is performed, it shall be reported under a separate test name.
4. Labeling Requirements—Distinguishing Amounts from Sweetening Raw Materials
The free glycine amount contained in the recommended daily intake shall be stated and distinguished from the weight of granules containing sugars or other sweetening raw materials. Neither sweetness nor a concentration indicator of the prepared solution alone shall serve as the basis for content. Where protein is also used, the formulation table, analytical conditions, and numerical fields on the packaging shall be cross-checked to verify that the total amount obtained after hydrolysis is not added to the free amount.
5. Quality Requirements—Formulation with Sugars and Storage Labeling
For products containing sugars, coloration, odor, and free glycine amount shall be monitored together in relation to heating during manufacture and subsequent storage. Crystalline raw materials shall be examined for clumping and ease of measurement after storage, and their condition at use shall not be determined solely from initial particle size documentation. The business operator shall establish storage specifications and shelf life using the actual packaging and shall present their basis. Labeling shall reflect the use of dry utensils, sealing, and handling after preparation.
6. Precautions for Intake
The product shall not be presented as a seasoning that may be added in arbitrary amounts because of its sweetness; the measuring method established for the product shall be clearly stated. Labeling shall be arranged so that the weights of metal glycine compounds or protein products are not reinterpreted as the recommended daily intake of a free glycine product. Persons undergoing treatment or taking medication shall be advised to consult a physician, and instructions to discontinue use and make contact in the event of an abnormal condition after use shall be proofread.
7. Documentation Management
Reports of free-form extraction values and total amounts after hydrolysis shall be retained in separate record systems so that the test category is carried forward when analyses are commissioned. Records of particle size, bulk density, measuring utensils, and the history of sugar formulation shall be linked to the product version. The business operator shall establish a retention period and maintain records that allow reconstruction of which extraction value was used to determine a previous labeled amount, even after changes to the crystalline state or formulation.
Article 5 (Evaluation Categories)
- Conformity: All requirements are met, and glycine identification, quantification excluding bound components, and actual measuring conditions are consistent.
- Partial conformity: The basis for the free amount and quality during storage is established, and a supplementation plan exists for deficiencies limited to matters such as documentation indexes for extraction categories.
- Nonconformity: The L-form proportion is treated as purity, values from protein hydrolysis are repurposed as free amounts, or content is determined from sweetness intensity.
Article 6 (Implementation)
The business operator shall make a self-declaration of conformity that clearly states the free-form extraction conditions. The Council shall compare the product formulation and sample preparation to verify whether bound components have been included in the labeled amount. Reassessment shall be performed when sugars, peptides, or granulation specifications are changed, and the correspondence between powder physical properties and measurement shall be checked during periodic review.
Supplementary Provisions
This Standard shall take effect on 7 September 2026. Inquiries concerning testing shall specify whether they concern free-form extraction or the total amount after hydrolysis.
※ This Standard sets out evaluation criteria for information disclosure and quality management practices and does not guarantee the efficacy or safety of individual products.