Storage Conditions and Best-Before Date Labeling Standard
JHFC-A-007 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)
The appearance, content and quality condition of health foods may change as a result of temperature, humidity, light, oxygen or handling after opening. Merely indicating a best-before date does not allow purchasers or distributors to reproduce the conditions on which that date is based unless the packaging configuration and storage conditions underlying it are communicated. Storage labeling that differs from the stability documentation also defeats the purpose of establishing the date. This Standard is established to manage storage conditions, best-before dates and supporting documentation as an integrated whole.
Article 1 (Purpose)
The purpose of this Standard is to ensure consistency among the basis for establishing storage conditions and best-before dates for health foods according to product characteristics, labeling methods, controls during distribution and information for use after opening, so that the conditions underlying the labeled best-before date can be verified.
Article 2 (Scope)
This Standard applies to storage labeling and the establishment of best-before dates for unopened health foods in tablet, capsule, powder, granule, liquid, jelly, oil and other forms and, where necessary, to storage labeling and the establishment of best-before dates after opening. Where laws and regulations or official guidelines prescribe specific methods of date labeling, those provisions shall take precedence.
Article 3 (Terms and Definitions)
- 1. Storage conditions: The environment and handling required by the labeling to maintain quality, including temperature, humidity, protection from light, tight closure and orientation.
- 2. Documentation for establishing best-before dates: Documentation linking the test plan, measurement results, packaging specifications and the decision determining the best-before date.
- 3. Stability indicators: Parameters selected to verify changes over time, including content, physical properties, microorganisms, oxidation and appearance.
- 4. Packaging equivalence: Equivalence to the packaging under evaluation in factors affecting storage, including material, light protection, seal integrity and capacity.
- 5. Conditions after opening: Conditions relating to the storage location, resealing method, handling or period of use after opening.
Article 4 (Requirements)
- 1. The business operator shall examine the dosage form, constituent ingredients, hygroscopicity, susceptibility to oxidation, sensitivity to light and microbiological characteristics, and shall select stability indicators. Reasons for not selecting particular parameters shall also be retained, and the scope of evaluation shall be verified using raw material information, product design documentation and the test plan.
- 2. The best-before date shall be established on the basis of storage tests covering the formulation, manufacturing process and packaging of the product actually marketed. Measurement time points, storage environments, sample lots and acceptance specifications shall be defined at the planning stage, and specification values shall be established by the business operator together with their supporting basis. It shall be verified that the determination of the best-before date can be reconstructed from the test results and approval records.
- 3. Where data obtained under accelerated conditions or documentation for similar products are used as supplementary evidence, the approach to conversion, formulation differences and packaging equivalence shall be explained, and a plan for verification under actual conditions shall be retained. The period shall not be extended without supporting evidence, and provisional and final best-before dates shall be linked to manufacturing lots and labeling versions.
- 4. Storage labeling shall not rely solely on terms such as "room temperature" but shall relate test conditions to routine handling, including environments to be avoided, whether tight closure is required and precautions concerning light or moisture. Containers and packaging, outer cartons, sales pages and accompanying documentation shall be cross-checked to verify that they do not indicate different conditions.
- 5. Best-before dates expressed as a year, month and day or as a year and month shall be linked to the manufacturing date of the relevant lot, the rules for calculating the best-before date and label printing records. Checks shall be made for incomplete printing, poor legibility or discrepancies between outer packaging and individual packages. When labels are replaced, the previous labeling, the reason, the person performing the replacement and the approval shall be recorded.
- 6. For products requiring controls after opening that differ from those applicable before opening, the labeling shall indicate resealing, storage location, contamination prevention and the approach to determining the handling period. Such labeling shall be based on tests simulating opening or a rational quality assessment and shall not create the mistaken impression that the best-before date for the unopened product remains applicable without modification after opening.
- 7. When the formulation, raw material supplier, process, packaging material, container capacity or logistics conditions change, the impact on the existing basis for the best-before date shall be assessed. Products found to have experienced temperature excursions, returns or improper storage shall be segregated from normal inventory, and their history, additional checks, eligibility for shipment and decisions on labeling corrections shall be recorded.
Article 5 (Assessment Categories)
- Conformity: The best-before date, storage labeling, sales packaging and stability documentation are consistent, and the basis for handling conditions, including those after opening, can be traced.
- Partial conformity: The principal documentation supporting the best-before date determination is available, but there are minor deficiencies in supplementary labeling across media or in change assessments, and a deadline for corrective action has been set.
- Nonconformity: There is no basis for the best-before date, the labeling indicates packaging or storage conditions that differ from those tested, or the printed best-before date cannot be traced to a lot.
Article 6 (Implementation)
The business operator may make a self-declaration of conformity after reviewing the documentation for establishing best-before dates, labeling samples and distribution records. Upon application, the Council may verify continuity from the labeled conditions to the test documentation and relevant lots. This Standard shall be reviewed in light of trends during storage, complaints, packaging changes or revisions to relevant regulatory systems.
Supplementary Provisions
This Standard shall take effect on 3 September 2026.
Note: This Standard provides assessment criteria for information disclosure and quality management practices and does not guarantee the efficacy, effects or safety of individual products.