Selenium Quality and Labeling Standard
JHFC-S-031 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)
Selenium is a component whose chemical species and total elemental amount need to be understood separately. Even when the total amount of selenium-containing yeast is known, the forms within the yeast cells and the proportion of residual inorganic selenium cannot be established from that amount. Furthermore, errors in the dilution or weighing of trace-level raw materials or in the transcription of units prevent raw material test results from supporting product labeling, even if those results are correct. This document is established as a standard for cross-checking total amount, chemical species, and dilution history.
Article 1 (Purpose)
The composition of selenium sources and the actual conditions of trace-level formulation shall be made transparent to prevent confusion between yeast amount, compound amount, and elemental amount. Evaluation shall combine verification of the five criteria under the overarching JHFC-A-001 with the requirements of this document for chemical speciation analysis and dilution records.
Article 2 (Scope)
This Standard covers health foods for oral consumption that identify selenium-containing yeast, organic forms such as selenomethionine, or inorganic forms as selenium sources. This listing does not constitute approval for the use of raw materials; before acceptance, the basis for food use shall be verified for each origin, processing method, and sales region.
Article 3 (Terms and Definitions)
- 1. Total selenium amount: The amount of selenium in a sample determined as the element, regardless of chemical species.
- 2. Selenium species: Forms of selenium distinguished by chemical structure, such as selenomethionine and selenite salts.
- 3. Selenium-containing yeast: A yeast-derived raw material containing selenium as a result of cultivation and processing.
- 4. Extractable fraction: The portion removed from a raw material by a specified procedure and subjected to chemical speciation analysis.
- 5. Stepwise dilution records: Records linking each stage of dilution from a high-concentration raw material to a raw material for product formulation.
Article 4 (Requirements)
1. Quality Requirements—Identification of Chemical Species and Yeast
For isolated compounds, specifications shall include structural and salt information; for yeast, they shall include the yeast species, the selenium source added, and the processing state. The entire selenium content shall not be described as a specific organic form solely on the basis of yeast origin. The business operator shall establish specifications for the total amount, the chemical species to be identified, and residual inorganic forms, and shall clearly state the extent confirmed by analysis and the unidentified portion.
2. Quality Requirements—Post-Cultivation Treatment and Dilution
During yeast recovery and washing, the state of separation between the culture broth and yeast cells shall be verified, and compositions before and after drying shall be cross-checked. When a concentrated raw material is diluted for formulation, the stock solution concentration, carrier additions, recovered amount, and residues on equipment shall be recorded. Weighed values and units shall be approved through a separate cross-checking step, and the sequence of dilutions shall be substantiated by concentration verification at each stage.
3. Testing—Total Amount and Extent of Extraction
Total selenium shall be measured with verification of losses during digestion and interference from coexisting substances. Chemical speciation analysis shall verify extraction recovery and transformations during the procedure, and the composition of the extract alone shall not be taken to represent the composition of the entire raw material. Third-party test results shall state the treatment of the unextracted portion, the quantification range, the sample stage, and the lot. The institution, method, and contact point for inquiries about the results shall be disclosed.
4. Labeling Requirements—Control of Trace-Level Units
The amount of selenium per recommended daily intake shall be stated as the element. When trace-level units are used together with other mass units, conversions between the certificate of analysis, formulation sheet, and label shall be recorded. Yeast amounts and selenomethionine amounts shall be shown under separate names. Where the proportion of a specific chemical species is additionally stated, it shall be clear whether the denominator is total selenium or the extracted fraction.
5. Quality Requirements—Storage of Trace-Level Mixtures
Nonuniformity caused by differences in particle size between the raw material and carrier shall be checked both immediately after manufacture and in samples subjected to simulated transport conditions. Moisture absorption and microbiological status shall be controlled for yeast raw materials, and products that label chemical species shall also be evaluated for changes in form after storage. The business operator shall establish specifications for uniformity, hygiene, and the end of shelf life and shall present their basis; cautionary statements concerning moisture and repeated opening shall be aligned with packaging material tests.
6. Precautions for Intake
Guidance shall be provided to check the ingredients and avoid overlapping intake, taking into account the combined use of selenium-only products and combined mineral products. A statement appropriate to the dosage form shall indicate that users shall not change the supplied measuring utensil or increase the amount by estimating it visually. Advice for persons undergoing treatment or taking medication to consult a physician, and to discontinue use in the event of an abnormal physical condition, shall be displayed in a location where it can be checked together with the recommended intake.
7. Documentation Management
Records tracing the lot genealogy from cultivation through washing, drying, and dilution shall be retained. The sections consulted in the [reference on the chemical forms of selenium](https://ods.od.nih.gov/factsheets/Selenium-HealthProfessional/) shall be registered, and labeling of a specific form shall additionally be linked to testing of the product concerned. Retention periods and access permissions shall be established, and when units are corrected, downstream calculations and publicly disclosed values shall be checked together.
Article 5 (Evaluation Categories)
- Conformity: All items can be verified, and there are no inconsistencies between total selenium, the explanation of chemical species, and the results of stepwise dilution.
- Partial conformity: The elemental amount, units, and necessary cautionary statements are reliably verified, and matters requiring supplementation are limited to minor deficiencies such as documentation indexes.
- Nonconformity: The entire amount of yeast is regarded as a specific chemical species, the dilution pathway is lost, or mass unit conversions are incorrect.
Article 6 (Implementation)
A self-declaration of conformity shall distinguish products that label only the total amount from products that also label chemical species. Upon application, the Council shall verify the correspondence between the extent of extraction and the labeling. Relevant documentation shall be reevaluated when the selenium source used in cultivation, washing method, or dilution method is changed.
Supplementary Provisions
The effective date shall be 7 September 2026. Inquiries to the Council shall specify whether verification concerns the total amount or chemical species.
※ This Standard sets out evaluation criteria for information disclosure and quality management practices and does not guarantee the efficacy or safety of individual products.