Iron Quality and Labeling Standard
JHFC-S-029 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)
Descriptions of iron quality require distinctions between source forms, such as iron salts, heme-containing ingredients, and coated raw materials, in addition to the total elemental amount. Although total iron measurement can verify the labeled amount, that result alone cannot demonstrate the valence of the raw material or its heme structure. Uneven mixing of iron-containing particles, contamination from manufacturing equipment, and color changes in foods also affect the interpretation of documentation; therefore, the roles of chemical form identification and product testing are specified separately.
Article 1 (Purpose)
The purpose of this Standard is to substantiate the origin of iron sources, labeling concerning their forms, and elemental amounts through appropriate tests and records for each. Based on the five information disclosure criteria established in JHFC-A-001, this document adds evaluation of the chemical state of iron and contamination arising from manufacturing.
Article 2 (Scope)
This Standard applies to oral health food products formulated with iron salts, food-derived heme-containing raw materials, or coated or dispersed iron raw materials and labeled with the amount of iron. It includes powders, tablets, liquid products, and similar forms. The eligibility of each raw material for food use shall be verified using documentation from the source and the applicable regulatory system.
Article 3 (Terms and Definitions)
- 1. Total iron amount: The amount measured as elemental iron present in a sample, without distinguishing chemical forms.
- 2. Iron valence: Information distinguishing the chemical state of a raw material, such as divalent or trivalent iron.
- 3. Heme-containing raw material: A food raw material in which a component with an iron-containing porphyrin structure has been verified.
- 4. Coated iron raw material: A preparation in which particles or droplets of an iron source are covered with another material.
- 5. Process-derived iron contamination: Iron entering a product from sources other than the intended formulation raw materials, through equipment wear or similar causes.
Article 4 (Requirements)
1. Quality Requirements—Identification of Iron Sources
For iron salts, information on the chemical name, valence, and hydration shall be available and shall be verified using analytical documentation identifying the form. For heme-containing raw materials, evidence concerning animal species, anatomical part, extraction method, and heme structure shall be compiled. Statements guaranteeing heme content or valence solely on the basis of total iron amount shall not be used. The business operator shall establish specifications for raw material purity and co-extracted substances, with supporting grounds.
2. Quality Requirements—Mixing and Equipment Control
For iron particles of different densities, the order of addition, segregation during transfer, and concentration differences during filling shall be evaluated. The materials of mills and liquid-contact parts shall be inspected, and contamination by wear particles shall be treated separately from the intended iron component. Coated raw materials shall be examined for coating damage caused by shear during mixing. Results for each sampling segment, equipment inspection records, and reconciliation of batch input amounts shall be used in lot disposition decisions.
3. Testing—Distinguishing Total Iron from Form Verification
Third-party testing of total iron shall verify digestion recovery from samples containing coatings or heme, reagent blanks, and instrumental interference. Where valence or heme is labeled, separate analytical documentation obtained while preserving the target structure shall be used in combination. The testing institution, method, stage tested, and product lot shall be stated in the certificate of analysis and publicly disclosed information, and the contact point for inquiries concerning the original documentation shall be identified.
4. Labeling Requirements—Calculation of Iron Amounts
Iron contained in the recommended daily intake shall be expressed as an elemental amount and shall be managed in a field separate from the formulation weight of heme-containing ingredients or coated raw materials. Where multiple iron sources are used, the contribution from each addition shall be reconciled with the total iron value of the product. Iron naturally present in raw materials shall not be counted twice. Supplementary statements on origin or valence shall remain within the scope of the corresponding identification tests.
5. Quality Requirements—Coexisting Components and Storage
For formulations containing fats and oils, colorants, or flavoring raw materials, changes in odor, color, and precipitation caused by contact with the iron source shall be observed over time. Increases or decreases in the iron amount shall not be judged solely from changes in appearance, and where a form is labeled, its retention shall also be verified. The business operator shall establish assessment specifications during storage, and storage instructions shall be labeled on the basis of documentation on the moisture-barrier properties of packaging materials and the condition of coatings.
6. Precautions for Intake
Labeling shall indicate a storage location that prevents children from inadvertently accessing the product, and the packaging form and opening and closing method shall be included in the review of draft cautionary statements. Guidance shall be provided on checking for duplicate intake when using other iron-containing products concurrently. A statement advising persons undergoing treatment or taking medication to consult a physician, together with guidance on seeking consultation in the event of accidental ingestion or abnormal physical symptoms, shall be established by reference to sources such as [documentation on iron precautions](https://ods.od.nih.gov/factsheets/Iron-HealthProfessional/).
7. Documentation Management
Total iron test results and valence or heme identification results shall be retained under separate document numbers, and an index shall identify which label statements each supports. Investigations of equipment-derived contamination shall be recorded separately from raw material acceptance testing. The business operator shall establish retention periods and shall maintain iron source change histories, coating formulations, and draft cautionary statements in a form searchable by product lot.
Article 5 (Evaluation Categories)
- Conformity: All requirements are met, the total iron amount and form labeling can be verified through independent evidence, and process-derived contamination has also been evaluated.
- Partial conformity: Documentation on iron sources, testing, and cautionary statements concerning accidental ingestion is in place, and matters requiring supplementation are limited to minor items such as publicly disclosed indexes.
- Nonconformity: Total iron is reinterpreted as the heme amount, iron from wear is included in the basis for product release without investigation, or elemental labeling cannot be reproduced.
Article 6 (Implementation)
A self-declaration of conformity shall be submitted listing the iron sources and the chemical information labeled. Based on the application, the Council shall separately verify evidence for total iron measurement and form labeling. The declaration shall be reviewed when liquid-contact materials, coating composition, or the heme extraction process is changed.
Supplementary Provisions
The effective date of this document shall be 7 September 2026. Documentation concerning the interpretation of iron amounts and raw material forms shall be accepted at the Council's inquiry contact point.
※ This Standard sets out evaluation criteria for information disclosure and quality management practices and does not guarantee the efficacy or safety of individual products.