Information Disclosure Standard for Imported Health Foods

JHFC-A-009　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)

For imported health foods, differences in language, regulatory systems, units or responsible entities arise between product specifications, labeling and test documentation prepared overseas and information on products sold in Japan. Merely reproducing labeling intended for overseas markets does not identify the formulation, manufacturing lot or checks performed at importation for the product intended for Japan. The fact that a product has cleared customs does not in itself signify verification of quality. This Standard is established to link and disclose information from overseas source documentation through domestic labeling and responsibility for distribution.

Article 1 (Purpose)

The purpose of this Standard is to organize information on the manufacturing entity, country of origin, formulation, importer, testing, labeling conversion and domestic inquiry contact for imported health foods, and to assess whether the basis for disclosed information and the relevant lots can be verified.

Article 2 (Scope)

This Standard applies to health foods imported as finished products and sold domestically, health foods manufactured overseas and packaged or labeled domestically, and products shipped directly from overseas to purchasers in Japan where a domestic business operator controls the sales labeling.

Article 3 (Terms and Definitions)

• 1. Original product information: Formulations, specifications, labeling samples and test documentation controlled by the overseas manufacturer.
• 2. Entity responsible for domestic labeling: The entity that reviews labeling intended for Japan and bears responsibility for published content and responses to inquiries.
• 3. Labeling conversion table: A record that maps, for each item, the source text, translated text, unit conversions, the decision to adopt or omit the item for Japan, and the supporting basis.
• 4. Import lot correspondence: The relationships among overseas manufacturing lots, transport units, import records and domestic sales lots.
• 5. Country-of-origin information: Information on the country or region indicated in accordance with applicable laws and regulations, based on the actual final manufacturing or processing operations.

Article 4 (Requirements)

• 1. Disclosed information shall include the name of the importer or entity responsible for domestic labeling, its location or contact method, an indication of whether the country stated is the country of manufacture or the country of origin, and information identifying the manufacturing entity for the finished product. Even where the factory name is not routinely disclosed, the type and scope of manufacturing controls shall be indicated, and documentation that can be checked upon inquiry shall be retained.
• 2. It shall be distinguished whether the product intended for Japan is identical to the product distributed overseas or differs only in formulation, dosage form, net quantity, packaging or labeling. Product codes, formulation documents, packaging specifications and purchase order records shall be cross-checked, and documentation for a different overseas specification shall not be presented as the supporting basis for the product intended for Japan.
• 3. Ingredient names, content, recommended intake, storage conditions and cautionary information shall be transcribed from the original product information into the labeling conversion table, and the translator and reviewer shall be recorded. Calculation steps for unit conversions or conversions to a daily amount, and the mapping of ingredient names, shall be retained so that recalculation from the domestic labeling is possible in accordance with JHFC-A-005.
• 4. Before shipment, a review shall be conducted against domestically applicable laws and regulations and official systems to determine whether there are prohibited ingredients, impermissible labeling methods or regulatory terms, or required cautionary information. Overseas marketing authorizations, notifications or classifications shall not be presented as though they confer the same status in Japan. The official information consulted and the review date shall be recorded.
• 5. For each import lot, the overseas manufacturing lot, shipping or dispatch records, documentation relating to import declarations, domestic receipt and sales recipients shall be linked. Where control conditions apply to temperature, sealing or container condition during transport, their history and assessments of deviations shall be verified in receipt records.
• 6. Specifications for identity, purity, microorganisms, chemical contaminants and other relevant parameters shall be established by the business operator in light of product characteristics and domestic handling, and shall be disclosed or made available upon inquiry together with their supporting basis. Where third-party testing is stated in the labeling, the stage at which the sample was taken, parameters covered, entity conducting the testing and lot shall be indicated, and overseas certificates of analysis shall be distinguished from domestic acceptance decisions.
• 7. A channel shall be established for receiving notifications from the overseas manufacturer of changes to formulations, processes, facilities, specifications or labeling. Notifications, translations, domestic impact assessments, inventory actions and updates to disclosed information shall be linked. Where the overseas manufacturer is consulted regarding a complaint or inquiry, the response and the final domestic decision shall be retained.

Article 5 (Assessment Categories)

• Conformity: Specifications for Japan, overseas source documentation, import lots, domestic labeling and responsible entities correspond, and the translation and conversion processes can be verified.
• Partial conformity: Product identification and domestic review can be verified, but there are deficiencies in supplementary translation histories or disclosure items, and a correction plan has been recorded.
• Nonconformity: The product intended for Japan does not match the supporting documentation, the domestic responsible entity cannot be identified, or status under an overseas regulatory system has been incorrectly transferred to domestic labeling.

Article 6 (Implementation)

The entity responsible for domestic labeling may make a self-declaration of conformity using import lot correspondence tables, labeling conversion tables and acceptance decisions. Upon application, the Council may conduct sample-based checks from published pages back to the original product information. Conformity shall be reassessed when the supplying country, domestic regulatory systems, unit conversions unrelated to exchange rates or product specifications change.

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.

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