Chromium Quality and Labeling Standard
JHFC-S-032 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)
For chromium, verification of the total elemental amount and verification of valence are distinct tasks. The same evidence cannot establish both that a raw material contains chromium and that it has the intended trivalent form. Contamination from manufacturing equipment, reagents, or sampling utensils also affects trace analysis. This Standard is established to control chemical forms, contamination pathways, and transformations during analysis separately and to clarify the information underlying total amount labeling.
Article 1 (Purpose)
For foods formulated with chromium, identification of the intended form shall be distinguished from control of unintended forms, and the conditions for verification of labeling shall be established. Common information on the responsible entity, manufacturing, testing, content, and registration shall be verified under the overarching JHFC-A-001, together with the valence-specific evaluation in this document.
Article 2 (Scope)
This Standard covers health foods for oral consumption that use compounds or food ingredients containing trivalent chromium as chromium sources. Whether food use is permissible shall be verified for each compound, origin, and sales region, and conformity with this Standard shall not be treated as approval for use. Products intentionally formulated with hexavalent chromium are excluded from the scope.
Article 3 (Terms and Definitions)
- 1. Trivalent chromium: A form of chromium confirmed to have an oxidation state of +3.
- 2. Hexavalent chromium: A form of chromium with an oxidation state of +6, evaluated for contamination and similar concerns separately from the intended raw material.
- 3. Total chromium amount: The amount of chromium measured as the element, without distinction by valence or bonding state.
- 4. Valence preservation: Controls to prevent changes in the oxidation state under evaluation during procedures from sampling through analysis.
- 5. Procedural blank test: A test to verify the chromium background originating from reagents, containers, and procedures.
Article 4 (Requirements)
1. Quality Requirements—Verification of the Intended Form
Documentation indicating the compound name, bonding partner, origin, and food use shall be verified upon acceptance. In addition to total chromium test results, documentation confirming structure or valence shall be required to support characterization as trivalent. For yeast and similar materials, the bonding state shall not be determined solely from the material name. The business operator shall establish specifications for the intended form and impurities and shall present the supporting basis, distinguishing the [reference on chromium valence classification](https://ods.od.nih.gov/factsheets/Chromium-HealthProfessional/) from product testing.
2. Quality Requirements—Contamination Pathways and Manufacturing Control
Reagents such as acids and alkalis used in raw material processing, metals in contact with the material, and cleaning steps shall be documented in the process flow diagram. At points where equipment wear or carryover from a previous product is foreseeable, verification methods such as blank tests and swab tests shall be established. For trace-level additions, weighing records shall be linked from raw material subdivision through to the product, and uniformity test results and cleaning records shall accompany the release decision.
3. Testing—Procedures for Total Amount and Individual Valence States
Digested samples for total amount measurement shall be distinguished from samples for valence-specific testing. Evaluation of hexavalent forms shall verify transformations attributable to sampling containers, extraction solutions, storage time, and coexisting components, and shall indicate detection and quantification ranges. Nondetection shall not be unconditionally restated as absence. Information on the third-party institution's method, product lot, blank tests, and recovery shall be linked to publicly disclosed documentation, and a contact point for inquiries about the certificate of analysis shall be provided.
4. Labeling Requirements—Scope of Form Descriptions
Chromium content shall be expressed as the elemental amount per recommended daily intake. An additional statement that chromium is trivalent shall correspond to the documentation confirming that form. Compound amounts, yeast cell mass, or the weight of coordination partners shall not be included in the elemental amount. Transcription of trace-level units shall be cross-checked against the original certificate of analysis, and when test results for hexavalent forms are presented, the sample, method, and measurement limitations shall be stated nearby.
5. Quality Requirements—Forms During Storage
Formulation ingredients with oxidizing or reducing properties, the product's acid–base conditions, and packaging materials in contact with the product shall be documented, and the validity of the valence characterization during storage shall be evaluated. Preservation of form shall not be judged solely from an unchanged total amount. A plan capable of distinguishing transformations after sampling from changes within the product shall be used, and the business operator shall present specifications at the end of shelf life and their basis. Storage labeling shall reflect conditions such as moisture protection adopted in testing.
6. Precautions for Intake
Guidance shall be provided to enable users to check for overlapping intake from combined products containing chromium. Labeling shall advise persons using medicines or following a medically managed diet to consult a physician before intake. Cautionary information in public authoritative references shall be cross-checked against the product's intended users, and labeling review shall verify that no wording encourages users to change the recommended intake at their own discretion.
7. Documentation Management
Sampling conditions for valence-specific tests, procedural blank tests, storage times, and the time of analysis shall be retained together with the raw data. Total amount test results shall be registered separately from fields documenting evidence of valence, and the basis for any decision to omit testing shall also be retained. The business operator shall establish retention periods so that decisions on earlier lots can be rechecked even after changes to contact materials or analytical sample preparation.
Article 5 (Evaluation Categories)
- Conformity: All requirements are met, and the intended form, contamination pathways, and scope of applicability of valence-specific testing are explained.
- Partial conformity: The basis for the form, amount, and contamination evaluation is secured, and a deadline for supplementation is established for deficiencies limited to matters such as the public documentation index.
- Nonconformity: Trivalence is asserted solely on the basis of the total amount, valence transformations during analysis are left unaddressed, or nondetection is labeled as absence without qualification.
Article 6 (Implementation)
The self-declaration of conformity shall state the chromium form used and the contamination pathways evaluated. The Council shall review the respective roles of total amount testing and valence verification in application documentation. The evaluation shall be reviewed when the raw material's bonding partner, metals in contact with the material, or acid–base conditions during storage are changed.
Supplementary Provisions
This Standard shall take effect on 7 September 2026. Inquiries concerning the interpretation of valence-specific testing shall include the analytical conditions.
※ This Standard sets out evaluation criteria for information disclosure and quality management practices and does not guarantee the efficacy or safety of individual products.