Zinc Quality and Labeling Standard
JHFC-S-028 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)
Zinc raw materials include inorganic compounds, organic acid salts, and food ingredients such as yeast, and equal raw material weights do not necessarily contain equal amounts of elemental zinc. Names such as “chelate” or “yeast-derived” also cannot establish the chemical bonding state. A zinc-specific standard is established to support source descriptions and elemental quantification with separate evidence and to clarify the correspondence between processes for adding trace amounts and labeled amounts.
Article 1 (Purpose)
This Standard establishes procedures for cross-checking the identification of zinc compounds, impurities associated with their sources, and elemental amounts in products. JHFC-A-001 shall apply to entity identification, manufacturing control, third-party testing, content, and registration information, and this document supplements it with zinc-specific information that cannot be verified from the raw material name alone.
Article 2 (Scope)
This Standard covers tablets, capsules, granules, and liquid food products that label zinc as a principal component. Both compound raw materials and zinc-containing food ingredients are covered, but the food use of each raw material shall be verified separately. Products in which zinc originates from processing aids and for which zinc content is not labeled are outside the scope of this document.
Article 3 (Terms and Definitions)
- 1. Elemental zinc amount: The amount expressed as zinc element, excluding the weight of counterions, binding partners, and carriers.
- 2. Zinc source: A compound or food ingredient that introduces zinc into a product.
- 3. Coordination state documentation: Analytical and manufacturing records explaining the bonding between zinc and organic substances.
- 4. Cell-associated zinc: Zinc present in a raw material containing microbial cells, for which the name alone does not specify the bonding form.
- 5. Raw material concentration adjustment: A calculation for adjusting the weighed amount according to the zinc concentration of the received lot.
Article 4 (Requirements)
1. Quality Requirements—Source and Purity
The salt name, counterion, hydration state, or origin of the ingredient shall be identified in the receiving record, and chemical identification shall be combined with elemental analysis. Where chelate labeling is adopted, documentation shall be available that distinguishes the material from a sample consisting merely of a mixture of a zinc salt and an organic substance. The business operator shall establish specifications for zinc purity and binding partners and shall present the basis on which the structure or composition was verified.
2. Quality Requirements—Purification and Raw Material Concentration Adjustment
In the manufacture of organic acid salts, records of reaction, separation, washing, and drying shall be retained, and methods for controlling unreacted substances and residual salts shall be established. For yeast raw materials, washing after cultivation and the handling of zinc remaining outside the cells shall be verified. Batch charging shall be approved with the concentration at receipt taken into account, and weighing records before and after adjustment shall be cross-checked against results for each sampling location in the final mixture.
3. Testing—Elemental Amount and Source-Related Impurities
The final product shall be homogenized and measured using digestion conditions that allow zinc recovery. In multi-element preparations, interference from coexisting elements shall be checked. Lead, cadmium, and other test items shall be selected on the basis of the zinc source and purification documentation, and the reasons for their selection shall be recorded. The lot covered by third-party testing, the institution, the method, and the results of comparison with specifications shall be disclosed, and an original certificate of analysis available for inquiry shall be retained.
4. Labeling Requirements—Distinguishing the Element from the Ingredient
The amount of zinc per recommended daily intake shall be labeled as elemental mass. Where the amount of yeast or zinc salt is also stated, separate headings shall be used to avoid the misinterpretation that it is equal to the amount of zinc. The basis for moisture adjustment shall be recorded in calculations using the zinc content percentage. Terminology shall be verified using sources such as [documentation on zinc raw material forms](https://ods.od.nih.gov/factsheets/Zinc-HealthProfessional/), and labeled values shall be checked against analysis of the product concerned.
5. Quality Requirements—Moisture Absorption and Contact Materials
Moisture absorption by raw material salts, tablet softening, and precipitation in liquid products shall be observed, and the ability to withdraw the specified amount at the time of use shall be verified. It shall also be evaluated whether zinc contamination from containers, sachet packaging materials, or liquid-contact parts affects measured values. The business operator shall establish storage specifications and shall substantiate guidance on tight closure, dry conditions, or redispersion with packaging test records.
6. Precautions for Intake
Guidance shall identify the component by name so that duplicate zinc intake, including intake from other mineral products, can be recognized. Cautionary statements concerning use by persons outside the intended population, such as children, and continued use shall be established by cross-checking the product design against official documentation. Labeling shall advise persons undergoing treatment or taking medication to consult a physician and shall indicate a contact point for reporting abnormalities during use.
7. Documentation Management
The revision history of raw material concentrations shall be linked to formulation calculations, and a register shall be established that enables affected products to be located if incorrect weighing occurs through the use of a previous concentration. Explanations of coordination states, yeast washing documentation, and elemental analyses shall be retained with their respective evidentiary uses distinguished. The business operator shall establish documentation retention periods, the scope of disclosure, and responsibility for corrections, and shall verify the applicable lots before deletion.
Article 5 (Evaluation Categories)
- Conformity: All provisions are satisfied, and the description of the zinc source, concentration adjustment, and elemental amount in the final product are consistent.
- Partial conformity: Verification of identity and the amount in the product is complete, and deficiencies limited to matters such as register indexes are to be remedied within a specified deadline.
- Nonconformity: The ingredient amount is treated as the zinc amount, a bonding state is labeled without supporting documentation, or changes in raw material concentration cannot be reflected in batch charging.
Article 6 (Implementation)
A self-declaration of conformity shall be made with evidence compiled for each zinc source used. The Council shall examine concentration adjustment records by tracing back from the elemental labeling of the product under application. The evaluation shall be updated when the counterion, microbial cell treatment, or a formulation relevant to analytical interference is changed.
Supplementary Provisions
This Standard shall apply from 7 September 2026. Inquiries concerning zinc origin labeling shall include the raw material category.
※ This Standard sets out evaluation criteria for information disclosure and quality management practices and does not guarantee the efficacy or safety of individual products.