Arginine Quality and Labeling Standard
JHFC-S-036 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)
Arginine is supplied as a free base or a salt, and in formulations combined with acidic raw materials, the form of the raw material at addition may differ from its state in the product. Labeling cannot be verified if the salt weight is taken directly as the component amount or if the raw material is identified solely by a measured nitrogen value. Specific quality and labeling requirements are established to link the chemical form of the raw material, the acid-base conditions during formulation, and the calculation of the component amount.
Article 1 (Purpose)
This document requires that the content be substantiated with the salt form and stereochemical configuration identified, from receipt of arginine through final packaging. The five criteria of JHFC-A-001 shall apply to information disclosure, and the following provisions add verification items concerning counterions, related amino acids, and formulation with acids.
Article 2 (Scope)
This document applies to powders, tablets, capsules, and beverages formulated with L-arginine, its hydrochloride, or other salts for which food use has been confirmed. Foods containing arginine only as residues in proteins are excluded. For raw materials mixed with organic acids, the application documentation shall state whether they are simple mixtures or materials specified as particular salts.
Article 3 (Terms and Definitions)
- 1. Free base equivalent amount: The mass expressed as arginine itself, excluding the counterions constituting the salt and moisture.
- 2. Counterion composition: The types of ions constituting the salt together with arginine and the relationship between their amounts.
- 3. Related amino acid fraction: The fraction in which amino acids that may accompany the raw material, such as ornithine and citrulline, are identified and treated separately.
- 4. Acid-base conditions of the formulation: The acid-base conditions after contact with acidic raw materials or similar ingredients during manufacturing or preparation as directed by the labeling.
Article 4 (Requirements)
1. Quality Requirements—Salt Form, Identity, and Purity
Acceptance specifications shall state whether the material is a free base or a salt, its counterions, the treatment of moisture, and the designation of the L-form. Tests confirming the structure and documentation on stereochemical configuration shall be provided, and nitrogen determination shall not serve as the sole basis for identification. The business operator shall establish specifications for related amino acids and residual inorganic salts and shall present the basis for those specifications through comparison with reference materials and manufacturing method documentation.
2. Quality Requirements—Manufacturing Control of Neutralization and Purification
For materials produced by fermentation, separation from the culture broth, resin treatment, and crystal recovery shall be recorded; for materials produced by synthesis, residual starting materials and by-products shall be checked at each process stage. During salt formation, acid addition, endpoint determination, mother liquor separation, and drying shall be controlled. When the material is incorporated into products containing acids, localized differences in acid-base conditions and undissolved material shall be examined, and the order of addition shall be verified against manufacturing instructions and batch charging records.
3. Labeling Requirements—Conversion from Raw Material Weight
The arginine contained in the recommended daily intake shall be stated as a free base equivalent amount, accompanied by the name of the salt used. If the salt weight is also stated, it shall be placed in a separate field from the equivalent amount. Calculations reflecting purity, moisture, and counterion composition shall be cross-checked against the formulation sheet and analytical values, and a specific salt name shall not be assigned solely on the basis that an acid was subsequently added to the formulation.
4. Testing—Related Amino Acids and Analytes
For quantification commissioned from a third-party institution, separation of arginine from related amino acids shall be verified. For products formulated with protein, sample preparation conditions that prevent bound components from contributing to the measured arginine amount shall be validated. Salt composition shall also be cross-checked using counterion measurements. The institution name, test method, whether the sample is a raw material or a product, lot, and contact point for inquiries shall be disclosed, and extraction recovery results shall be retained.
5. Quality Requirements—Acid-Base Conditions of the Formulation and Storage Labeling
Moisture absorption and caking in powders, and acid-base conditions, precipitation, and changes in arginine amount in liquid products shall be observed in the actual packaging. Coloration shall also be monitored in formulations containing sugars, and content shall not be judged from appearance alone. The business operator shall establish storage specifications, packaging conditions, and shelf life for each dosage form and shall present their basis. Instructions on tight closure, the liquid to be used for preparation, and handling after preparation shall be stated on the basis of test results.
6. Precautions for Intake
When switching to an arginine product with a different salt form, users shall be advised to check the labeled equivalent amount and recommended daily intake rather than the raw material weight. Intake instructions shall not assume that users will make their own preparations by adding acidic foods. A statement advising persons undergoing treatment or taking medication to consult a physician shall be included, and the precautions section and dilution and measuring procedures shall be cross-checked using packaging samples.
7. Documentation Management
Results before and after salt formation, counterion analyses, conversion formulas, and changes in the acid-base conditions of the formulation shall be retained by raw material code. The [chemical information on L-arginine](https://www.ebi.ac.uk/chebi/CHEBI%3A16467) shall serve as a reference for checking the stereochemical designation, and the access date and items adopted shall be recorded. The business operator shall establish a retention period and shall ensure that conversion tables for previous formulations remain retrievable when the acid is changed.
Article 5 (Evaluation Categories)
- Conformity: All requirements are addressed, and the supporting evidence for the salt form, counterions, acid-base conditions of the formulation, and labeling of the free base equivalent amount is linked.
- Partial conformity: Identification, conversion, and storage assessment are complete, and only minor deficiencies in guidance for accessing publicly disclosed documentation remain, with a deadline for supplementation.
- Nonconformity: Salt weight is treated as the amount of arginine itself, identification relies solely on nitrogen values, or the state after acid addition cannot be verified.
Article 6 (Implementation)
The business operator shall make a self-declaration of conformity with the salt used and the conversion basis attached. The Council shall verify labeling calculations and neutralization records for each salt form included in the application. The declaration shall be reviewed when the counterion, purification resin, or acidic auxiliary raw material is changed and during periodic inspections.
Supplementary Provisions
This document shall take effect on 7 September 2026. Documentation for inquiries concerning salt forms shall include the counterion name and moisture basis.
※ This Standard sets out evaluation criteria for information disclosure and quality management practices and does not guarantee the efficacy or safety of individual products.