Citrulline Quality and Labeling Standard
JHFC-S-037 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)
Commercial citrulline raw materials include the isolated amino acid, preparations combined with malic acid, and plant extracts. Neither the name nor the formulation ratio of a mixed raw material alone determines the content or bonding state of citrulline itself. As extract composition also varies with the plant part used, this Standard is established to enable verification of the basis for raw material names, measurement of both components, and their distribution within the product.
Article 1 (Purpose)
For citrulline and raw material preparations containing it, raw material designations shall correspond to the analytes, and content labeling shall not rely solely on estimates based on formulation ratios. JHFC-A-001 shall serve as the overarching information disclosure standard, supplemented by provisions for descriptions of plant origin and verification when malic acid is used in combination.
Article 2 (Scope)
This document applies to single-component raw materials, raw materials containing malic acid, and plant extracts that specify L-citrulline, as well as granules, tablets, beverages, and similar products made with these materials. It does not apply to ordinary foods that label only the weight of the plant itself. For combination products, the portion to which citrulline labeling applies shall be identified, and the amounts of other amino acids shall be treated separately.
Article 3 (Terms and Definitions)
- 1. Specified citrulline amount: The mass of citrulline identified as the L-form, excluding malic acid and plant solids.
- 2. Raw material combined with malic acid: A raw material containing citrulline and malic acid for which the method of combination during manufacture requires separate explanation.
- 3. Ratio denominator: The calculation basis indicating whether the ratio is between the two components or is a proportion of the total raw material preparation.
- 4. Plant-derived fraction: The portion obtained by extraction, separation, or purification from the plant part used.
Article 4 (Requirements)
1. Quality Requirements—Identification of Isolated Materials and Plant Fractions
The structure of citrulline and information on its L-form shall be checked against reference materials, and the ability to separate related substances such as ornithine shall be verified. For raw materials described as plant-derived, the plant species, the part used, such as flesh or peel, and the scope of extraction shall be stated in acceptance documentation. An isolated material obtained by fermentation or synthesis shall not be described as a plant extract solely because the substance also occurs in plants.
2. Quality Requirements—Combination with Malic Acid
Process documentation shall identify whether co-crystallization, reaction, mixing in solution, or dry mixing was used. If the material is treated as a specific compound, evidence for identification, such as its solid state, shall be provided in addition to compositional measurements. The business operator shall establish specifications for citrulline purity, malic acid composition, moisture, and related substances and shall present their basis using measured values for both components.
3. Quality Requirements—Manufacturing Control of Crystallization and Granulation
During crystallization, the distribution of components in the mother liquor and recovered crystals shall be cross-checked; during granulation, uneven acid distribution and compositional differences by particle size shall be examined. Samples of dry mixtures shall include portions from the beginning and end of filling, and segregation after transport shall also be considered. For plant extracts, the solids balance during concentration and the composition before and after purification shall be recorded, and verification results for each manufacturing method shall be linked to the manufacturing lot.
4. Testing—Independent Measurement of Both Components
Third-party testing shall directly quantify citrulline, and malic acid shall also be measured separately for raw materials combined with malic acid. Results based solely on back-calculating the amount of one component from the formulation ratio shall not be used. It shall be verified whether product acidity or plant-derived components interfere with separation and recovery. Whether the sample is a raw material or a product, the institution name, method, each analyte, lot, and inquiry route shall be disclosed.
5. Labeling Requirements—Specified Amount and Ratio Notation
The specified citrulline amount per recommended daily intake shall be stated. If a ratio to malic acid is provided, the component order, whether the ratio is based on mass or amount of substance, and the ratio denominator shall be stated. The plant extract weight and citrulline amount shall be presented separately, and values calculated from amounts added shall be distinguished from measured values. Proposed labeling shall be reviewed by recalculation using results for both components and formulation records.
6. Quality Requirements—Storage and Preparation
Products combined with malic acid shall be examined for moisture absorption, clumping, and precipitation after dissolution; sedimentation and microbiological control shall additionally be examined for plant extract products. The business operator shall establish storage conditions, shelf life, and specifications with supporting evidence and shall label the utensils to be used and the method of dissolution. The reproducibility of preparation instructions shall be verified using the actual packaging, and component distribution after storage shall also be recorded.
7. Precautions for Intake
Users shall be advised not to add acid to adjust the formulation ratio, and the raw materials and liquids to be used for preparation shall be clearly specified. Persons undergoing treatment or taking medication shall be advised to consult a physician. Where plant extracts are included, labeling shall also allow the plant part used and auxiliary raw materials to be verified, and the recommended daily intake and cautionary statements shall be reviewed against preparation test records.
8. Documentation Management
The manufacturing method category for raw materials combined with malic acid, results for both components, and ratio calculations shall be compiled under the same document number. Records of checks against the [substance definition of L-citrulline](https://www.ebi.ac.uk/chebi/CHEBI%3A16349) shall be retained separately from proof of plant origin. The business operator shall establish a retention period and maintain an index that permits tracing back to previous packaging labels when the designation or denominator is changed.
Article 5 (Evaluation Categories)
- Conformity: All items are complete, and the manufacturing method category of the raw material, the citrulline amount, and the ratio to the component used in combination can be verified.
- Partial conformity: Direct quantification and the mixing state are adequately substantiated, and a supplementation schedule is provided for deficiencies limited to matters such as guidance on document numbers.
- Nonconformity: The mixture weight is treated as the specified amount, an unverified bonding state is labeled, or the formulation ratio alone serves as the basis for quantification.
Article 6 (Implementation)
The self-declaration of conformity shall state whether malic acid is used in combination and identify the manufacturing method category. The Council shall cross-check the designation of the raw material in the application against test documentation for both components. Reverification shall be performed when the plant part, crystallization conditions, or method of ratio labeling changes, and consistency with designations used in the market shall be checked during periodic review.
Supplementary Provisions
The effective date shall be 7 September 2026. Inquiries concerning combined use with malic acid shall clearly state the analytes and ratio denominator.
※ This Standard sets out evaluation criteria for information disclosure and quality management practices and does not guarantee the efficacy or safety of individual products.