Certificate of Analysis Content and Disclosure Standard
JHFC-A-003 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)
A certificate of analysis is important supporting evidence for quality information. However, an extract that omits the sample, lot, test method or issuing entity does not allow a determination of what was verified or for which product. Images showing only the assessment field and edited transcriptions also make correspondence with the original difficult to trace. This Standard is established to enable verification of the provenance and integrity of test results and the lot concerned, while giving due consideration to confidentiality.
Article 1 (Purpose)
The purpose of this Standard is to assess traceability from samples to publicly disclosed information and the clarity of the basis for assessment in the receipt, review, content, summary disclosure and retention of certificates of analysis relating to health foods.
Article 2 (Scope)
This Standard applies to certificates of analysis concerning the identity, content, physical properties, microorganisms, chemical contaminants and other quality attributes of raw materials, intermediate products and finished products. It covers both internal and external testing. Where legislation specifies separate retention or reporting requirements, those requirements shall take precedence.
Article 3 (Terms and Definitions)
- 1. Sample identifier: Information that uniquely traces the test subject, including the sample name, sampling source, lot and sampling date.
- 2. Original certificate of analysis: A certificate of analysis issued by the entity conducting the tests, or an electronic record protected against alteration, whose approval status can be verified.
- 3. Public summary: Documentation presenting the key details of the sample, test items, methods, results and issuing entity while protecting confidential information.
- 4. Assessment specification: Criteria for acceptance or release established by the business operator for each product or raw material, with the supporting basis and applicable version under control.
- 5. Correction history: A record of changes made after issuance, identifying the items changed, reasons, persons making the changes and dates.
Article 4 (Requirements)
- 1. The certificate of analysis shall state the sample identifier, the sample's stage of production, the date of receipt or sampling, the testing period, the date of issuance and the issuing entity. The business operator shall cross-check receiving records, manufacturing records or shipment records to verify that the certificate of analysis is linked to the lot concerned.
- 2. For each test item, the name or identification number of the test method, result, unit, assessment specification and assessment outcome shall be linked. The business operator shall establish the assessment specification values and control their supporting basis, applicability and version. After a specification is revised, the previous version shall not be applied retroactively. Verification shall be conducted by cross-checking the versions of the test procedures and specifications.
- 3. Where a limit of quantification, limit of detection or "not detected" is stated, the meaning of the term under the test method on which it is based shall also be stated. Where numerical values have been rounded, converted or corrected, the processing method shall be recorded, and calculation records shall verify that the values in the certificate of analysis can be reproduced from the original data.
- 4. Where external testing is publicly presented as "third-party testing," the official name of the testing laboratory, the test items, the sample's stage of production and the lot concerned shall be stated. Assessment specifications provided by the commissioning party shall be distinguished from the testing laboratory's own assessment, and the test request, receipt records and original certificate of analysis shall be cross-checked against one another.
- 5. The public summary shall not selectively distort the results of the original certificate of analysis and shall clearly state the scope of the items tested and the items disclosed. Even where personal names, transaction terms or similar information are withheld, the issuing entity, sample identification, methods and results necessary for verification shall remain available. Versions before and after public disclosure shall be retained, and transcriptions shall be cross-checked against the original certificate of analysis.
- 6. Original certificates of analysis and reference information for the associated raw data shall be retained in a repository with controlled access permissions. Replacements or corrections shall be approved with a correction history, without deleting previous versions. The integrity of electronic records shall be verified using access histories or records capable of detecting alterations.
- 7. Where results deviate from specifications, sample information is inconsistent or a certificate of analysis is missing, the assessment shall be placed on hold, and the affected lots, causes and actions taken shall be recorded. Retesting shall not replace the initial results. The reason for retesting and both sets of results shall be linked, and evidence of the authorized person's release decision shall be retained.
Article 5 (Assessment Categories)
- Conformity: The original certificate of analysis, lot concerned, assessment specification and public summary are traceable, and complete records, including corrections, are available.
- Partial conformity: There are minor deficiencies in content or disclosure that do not compromise the validity of the assessment, and corrective action records specify the scope and deadline.
- Nonconformity: The sample or lot cannot be identified, results do not match the original records, or assessment records for deviations are absent.
Article 6 (Implementation)
The business operator may make a self-declaration of conformity on the basis of the list of certificates of analysis, the lot correspondence table and public summaries. At the time of application, the Council may perform tracing on a sample basis from public documentation to the original certificates of analysis. The required content and verification procedures shall be reviewed in response to changes in test methods, information media or relevant schemes.
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.