Ornithine Quality and Labeling Standard
JHFC-S-046 Enacted: 8 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: 8 September 2026 / Effective: the same day
Preamble (Rationale for Enactment)
In foods containing ornithine, the amount added as a purified raw material and the amount inherently present in a food extract may be presented in the same explanatory field. Furthermore, the input weight of the hydrochloride salt, the concentration in dry matter, and the content in the product as sold have different calculation bases. As a description of food origin alone does not allow the constituent amount to be traced, this Standard establishes a link between the amount contributed by each raw material and measurements of the final product.
Article 1 (Purpose)
This Standard establishes requirements for verifying the correspondence between the supply form of ornithine, carryover during manufacture, and the labeled amount. The overarching standard JHFC-A-001 shall apply to disclosure concerning entity identification, manufacturing certification, third-party testing, content, and registration under applicable schemes, and this document shall supplement it with quantity verification for each raw material.
Article 2 (Scope)
Products Covered
This Standard applies to L-ornithine for food use, salts such as the hydrochloride, and products formulated with food extracts that declare an ornithine amount. It includes powders, granules, tablets, capsules, and beverages. General foods that state only the name of an extract without establishing quality specifications for this constituent shall not be eligible for a declaration of conformity with this Standard.
Article 3 (Terms and Definitions)
- 1. Amount contributed by raw materials: The amount of ornithine entering a batch, calculated from the measured concentration and amount used of each food raw material.
- 2. Separately added amount: The amount of purified ornithine raw material added separately. It shall be identified as a component of the amount contributed by raw materials.
- 3. Anhydrous free-form basis: A basis for expressing mass as the ornithine portion, excluding the counterion constituting the salt and moisture.
- 4. Carryover raw material: Powder, solution, or intermediate recovered from a previous manufacturing unit and used in the next batch.
Article 4 (Requirements)
1. Quality Requirements—Ornithine Identity and Purity
The structure of the L-form shall be identified by comparison with [chemical structure documentation](https://www.ebi.ac.uk/pdbe-srv/pdbechem/chemicalCompound/show/ORN) and a reference sample. For salt raw materials, the salt type and moisture basis shall be clearly stated in the specification document. The business operator shall establish specifications for other amino acids, residual salts, and impurities associated with each origin, and shall present analytical profiles and purification records as supporting evidence.
2. Quality Requirements—Manufacturing Control Including Recovered Materials
The process flow diagram shall identify whether fermentation, enzyme treatment, or extraction is used, and substrates, separated liquids, and recovered crystals shall be linked by lot. Where carryover raw material is used, its remaining quantity and concentration shall be reconfirmed, and a batch formulation sheet combining it with newly added materials shall be approved. The cycles in which mother liquor is reused shall be recorded, and the concentration of the previous lot shall not be applied to the next cycle without verification.
3. Testing—Verification of Separation in Food Extracts
Quantification of the final product by a third-party institution shall verify separation from coexisting constituents such as lysine and arginine. For methods involving derivatization, the effects of insufficient reagent or food pigments shall be investigated by spike recovery testing. The testing institution name, method, classification of the sampled material as a raw material or product, lot, and contact point for inquiries shall be disclosed, and records covering sample preparation through calculation shall be retained.
4. Labeling Requirements—Contributed Amounts and Product Content
The ornithine amount per recommended daily intake shall be stated on an anhydrous free-form basis. The name of the salt used shall be stated, and the formulation weight of the salt raw material, if provided, shall be distinguished from the ornithine amount. Where the extract-derived amount and the separately added amount are explained, the results for each raw material and the batch input quantities shall be shown, and the component amounts shall not be added twice to the product total. Conversions into a number of food items or similar quantities shall be accompanied by the measurement data used.
5. Quality Requirements—Mixed Powders and Storage Labeling
Formulations combining extract powder and crystalline raw materials shall be examined for constituent variation from the start to the end of filling and for caking caused by moisture absorption. For liquid products, content shall be verified after hot filling and after storage. The business operator shall establish specifications for uniformity, changes in content over time, microorganisms, and packaging, with supporting evidence, and shall label instructions for tight closure after opening and measuring methods in accordance with tests using the actual packaging.
6. Precautions for Intake
The daily amount shall be described in the product's units of measurement rather than by the weight of the extract it contains. A statement shall advise users to check the recommended amount and ingredients on each package when using other ornithine-containing foods concurrently. A statement advising persons undergoing treatment or taking medication to consult a physician shall be included, and allergy cautionary statements related to the origin of the extract shall be checked for consistency with the ingredients field.
7. Documentation Management
Calculation sheets for amounts contributed by raw materials, carryover ledgers, analytical profiles of food extracts, and packaging drafts shall be accessible through the same product number. Conversions from a dry-matter basis to an as-is basis shall be recorded, and the dates on which raw material results are updated shall be retained. The business operator shall establish the retention period and shall check whether the calculation process can be presented in response to inquiries about amounts by origin.
Article 5 (Evaluation Categories)
- Conformity: All requirements are satisfied, and reconciliation of amounts contributed by raw materials, recovered materials, and labeled product content is complete.
- Partial conformity: Identity, final content, and the batch mass balance can be verified, and a deadline for supplementation is stated solely for minor deficiencies in guidance on documentation.
- Nonconformity: Double counting of separately added amounts, incorrect transcription of salt weight, or unknown quantities of carryover raw material are identified.
Article 6 (Implementation)
The self-declaration of conformity shall be accompanied by a classification of the extracts and purified raw materials used. The Council shall verify the calculation of contributed amounts and third-party results from the application documentation. Rechecks shall be performed when supply forms or carryover procedures change, and discrepancies with the labeled breakdown shall be checked during periodic review.
Supplementary Provisions
This document shall take effect on 8 September 2026. Inquiries concerning contributed amounts shall specify the raw materials concerned and the calculation basis.
※ This Standard sets out evaluation criteria for information disclosure and quality management practices and does not guarantee the effects, efficacy, or safety of individual products.