Calcium (Derived from Minerals Such as Dolomite) Quality and Labeling Standard
JHFC-S-006 Enacted: 3 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: 3 September 2026 / Effective: the same day
Preamble (Rationale for Enactment)
Mineral-derived calcium raw materials differ in the chemical form of calcium, coexisting elements such as magnesium, and the state of insoluble components, depending on the mineral deposit from which they are mined, their mineral composition, and processing such as calcination. The name dolomite alone does not indicate the amount of elemental calcium, and raw material weight is not equivalent to calcium content. Natural minerals may also contain accompanying elements of geological origin. This Standard is established to correlate mineral species, mining origin, chemical form, and elemental content, and to enable verification of testing and labeling appropriate to the mineral source.
Article 1 (Purpose)
The purpose of this Standard is to evaluate mineralogical and chemical identity, mining and processing provenance, conversion to elemental content, formulation form, stability, testing for accompanying elements, and cautionary statements for health foods containing calcium raw materials originating from dolomite, limestone, or other minerals.
Article 2 (Scope)
This Standard applies to oral products made with calcium carbonate, calcium oxide, or other calcium compounds obtained from natural minerals. Calcium raw materials originating exclusively from shells, eggshells, coral, milk, or other non-mineral sources are excluded. Where materials from multiple origins are blended, the mineral-derived portion shall be distinguished.
Article 3 (Terms and Definitions)
- 1. Mineral-derived calcium: A calcium raw material obtained by beneficiating, grinding, calcining, reacting, or refining mined minerals.
- 2. Mineral source information: Information on the mineral name, mine or mining area, identification of the mineral deposit, and location of primary processing.
- 3. Chemical form: The compound form in which calcium is present in the product, such as a carbonate, oxide, or hydroxide.
- 4. Elemental calcium content: The amount determined as the element calcium, rather than the weight of the compound or raw material.
- 5. Accompanying elements: Elements originating from the mineral deposit or processing steps that may enter the raw material together with calcium.
Article 4 (Requirements)
- 1. The raw material shall be specified by distinguishing the mineral name from its chemical form, and its identity shall be confirmed using multiple types of information appropriate to its state, such as diffraction, spectroscopy, or elemental composition. For dolomite, consistency with its identity as a carbonate mineral containing calcium and magnesium shall be examined; detection of a single element alone shall not be used to identify dolomite. Following calcination or reaction, specifications reflecting the phase changes caused by processing shall be used.
- 2. The mine or mining area, mineral deposit or mining lot, beneficiation location, and refining location shall be identified, and grinding, washing, calcination, slaking, neutralization, and other processing steps shall be recorded in the raw material specification. Where materials from different mineral sources are mixed, records of identification before mixing and blending controls shall be retained. Origin labeling shall be supported by mining and supply documentation and process flow diagrams.
- 3. Content shall be expressed in units of mass of elemental calcium corresponding to the recommended daily intake. The amounts of mineral raw material, calcium compound, and elemental calcium shall not be used interchangeably. Where magnesium in dolomite is also declared, each element shall be quantified separately. Where corrections are made for the state after drying or ignition, or for the hydration state, the conversion formula shall be retained. The business operator shall establish and present the basis for declared values and specifications.
- 4. For each form, such as tablets, capsules, powders, granules, or liquid suspensions, the effects of particle size, dispersion, sedimentation, moisture absorption, caking, and reactions with other ingredients on sampling representativeness and quantitative results shall be evaluated. For products containing sparingly soluble particles, the validity of sample homogenization and digestion procedures shall be confirmed, and content shall not be determined from only a portion such as the supernatant.
- 5. Stability evaluation shall include observations of caking, precipitation, or changes in form associated with chemical form, moisture, contact with carbon dioxide, liquid properties, and packaging conditions. For liquid products or combination formulations, the ability to take the specified amount even after precipitation shall be confirmed. Storage conditions, redispersion methods, and criteria for maintaining declared values shall be established by the business operator on the basis of product-specific data.
- 6. Test items shall include identity, elemental calcium content, and, where necessary, magnesium content. Taking account of geological documentation for the mineral source and the manufacturing method, test items shall be selected from lead, cadmium, arsenic, mercury, other accompanying elements, acid-insoluble matter, and other relevant substances. Reasons for exclusions shall also be recorded. The completeness of sample digestion, interference, and limits of quantification shall be confirmed in the analysis, and the business operator shall present each specification and its basis.
- 7. Labeling shall consistently state the mineral origin, raw material name or chemical form, elemental calcium content, the identity of any additionally declared elements, and instructions for use appropriate to the product form. For products subject to sedimentation, the necessary redispersion method shall be indicated. Advice to seek consultation for persons using medicinal products or under medical supervision, a statement not to exceed the recommended intake, and instructions to discontinue use in the event of adverse symptoms shall be provided on the basis of the latest official information and product-specific evaluation.
Article 5 (Evaluation Categories)
- Conformity: The mineral species and chemical form after processing are identified, and the mineral source, elemental calcium content, uniformity within the formulation, and testing for accompanying elements are mutually consistent.
- Partial conformity: Elemental content and mineral origin can be confirmed, but supplementary information is required on the mineral deposit history or the representativeness of sampling for suspension products, and a corrective action plan is in place.
- Nonconformity: Raw material weight is declared as elemental calcium content, mineral species is determined from a single element alone, or accompanying elements appropriate to the mineral source have not been evaluated.
Article 6 (Implementation)
The business operator may issue a self-declaration of conformity on the basis of mineral source documentation, processing flow diagrams, results of mineral and chemical form identification, elemental analysis, and formulation stability documentation. Upon application, the Council may verify traceability from the declared elemental content to the mineral used, mining lot, and sample digestion records. Reevaluation shall be conducted when the mineral source, calcination conditions, chemical form, particle size, dosage form, or analytical method is changed.
Supplementary Provisions
This Standard shall take effect on 3 September 2026.
※ This Standard sets out evaluation criteria for information disclosure and quality management practices and does not guarantee the efficacy or safety of individual products.