Document and Version Control Standard for Health Foods
JHFC-A-010 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)
Quality information for health foods is distributed across different documents and media, including specifications, formulation documents, test documentation, labeling drafts and sales pages. If files are overwritten so that only the latest version is retained, it is not possible to establish retrospectively which specifications and labeling applied to a particular product lot. Conversely, if obsolete documents remain at points of use or with business partners, superseded conditions may be reused. This Standard is established to control documents by version throughout their creation, approval, distribution, revision, invalidation and retention.
Article 1 (Purpose)
The purpose of this Standard is to define responsibilities for the identification, review, approval, distribution, modification and retention of documents relating to the quality and labeling of health foods, and to assess whether the versions applicable to each product lot and at each time of publication can be reconstructed.
Article 2 (Scope)
This Standard applies to raw material and product specifications, formulation documents, manufacturing and testing procedures, certificates of analysis, labeling drafts, materials published on the web, training materials, supplier documents, and the paper-based and electronic systems used to control them. It also covers one-time communications that change quality decisions.
Article 3 (Terms and Definitions)
- 1. Controlled documents: Documents and records subject to identification and approval as the basis for quality decisions, operations or external labeling.
- 2. Version identifier: A combination of numbers, symbols or dates that uniquely indicates the revision status.
- 3. Master document repository: A storage location where authoritative copies and effective versions are designated and viewing permissions are controlled.
- 4. Distribution register: A record indicating the departments, contractors and media to which controlled documents have been provided, together with the versions distributed.
- 5. Invalidation: Measures to remove obsolete versions from routine use and clearly indicate their status as historical documentation.
Article 4 (Requirements)
- 1. For each type of controlled document, the business operator shall designate an owner, author, specialist reviewer, approver and master document repository. The document number, title, version identifier, effective date and status shall be shown on the document. The document register shall be cross-checked against the documents actually stored to verify that no unregistered documents exist.
- 2. For initial issuance and revisions, the reasons for change, sections affected, supporting documentation, affected products and conditions for implementation shall be recorded. Documents shall not be finalized by the author alone. The persons responsible for quality and labeling shall review their respective aspects, and the approval sequence shall be verifiable from the dates and times of electronic approvals or signatures.
- 3. Reference relationships shall be established among specifications, formulations, test methods, labeling and sales materials. When ingredient names, content, storage conditions or cautionary information change, a list of affected documents shall be used to determine whether revisions are required, and reasons shall also be retained for documents that are not changed. Cross-references and combinations of versions shall be verified using a product-specific document table.
- 4. Effective versions shall be distributed in a controlled manner to points of use, contract manufacturers, testing laboratories and labeling media. Receipt, publication or incorporation into systems shall be verified, and obsolete versions shall be made unavailable for routine retrieval, printing or operational use after their invalidation date. Completion of the changeover shall be assessed using the distribution register, withdrawal records and checks of displayed pages.
- 5. For manufacturing lots and shipment lots, the versions of the applicable raw material specifications, formulations, manufacturing procedures, test specifications, packaging specifications and labeling drafts shall be recorded. For transitional products around the effective date, the boundary between the applicability of the previous and new versions, inventory actions and approvers shall be explicitly identified and shall not be inferred solely from dates.
- 6. For websites, e-commerce pages and files intended for distribution, the publication start and end dates, publication locations, published versions and approved drafts shall be retained. Reproduction or abbreviated labeling by external business operators shall also be subject to verification, and unauthorized edits shall be detected by comparing captured records of published pages with approved drafts.
- 7. The business operator shall establish retention periods in consideration of laws and regulations, contracts, best-before dates, distribution periods and the possibility of inquiries, and shall document the basis. If use of an incorrect version is discovered, the relevant lots and media shall be identified and use of the incorrect version shall be stopped. Corrections, notifications, reassessments and measures to prevent recurrence shall be traceable through the version history.
Article 5 (Assessment Categories)
- Conformity: Responsibilities for controlled documents, effective versions, distribution recipients and applicability to product lots are clear, and the history, including obsolete versions, can be reconstructed.
- Partial conformity: The principal documents are controlled, but there are deficiencies in registers or distribution verification for supporting documents, and measures to prevent incorrect use and a corrective action plan are in place.
- Nonconformity: Unapproved versions are used, applicable versions cannot be linked to lots, or obsolete versions are circulating as effective versions.
Article 6 (Implementation)
The business operator may make a self-declaration of conformity through sample-based cross-checks of the document register, version history and distribution recipients. Upon application, the Council may verify the combination of applicable documents for a selected lot or publication date. This Standard shall be reviewed when media, the scope of outsourced activities or document control systems change, and during periodic audits.
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.