Raw Material Traceability Standard
JHFC-A-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)
Raw materials for health foods may pass through multiple business operators and lots from the collection site through processing, refining, subdivision and incorporation into formulations. Even where names are identical, correspondence with specifications changes if the source organism, part used, collection period or processing history differs. The supplier shown on transaction documents alone does not allow upstream branching or mixing to be reconstructed, nor does it allow the affected scope to be determined when abnormalities occur. This Standard is established to ensure controls that allow received raw materials to be traced in both directions, to their starting points and to the products in which they are used.
Article 1 (Purpose)
The purpose of this Standard is to assess whether the identification, supply routes, lot transformations and product use histories of raw materials for health foods are recorded so that the documentation used for quality assessments and the scope affected by abnormalities can be reconstructed.
Article 2 (Scope)
This Standard applies to the procurement, transport, receipt, storage, subdivision, mixing and issue to manufacturing of raw materials and additives derived from plants, animals, microorganisms, minerals, fermentation products and chemically synthesized substances. It includes transactions through trading intermediaries, overseas procurement, repackaging and consolidation of multiple lots.
Article 3 (Terms and Definitions)
- 1. Raw material genealogy: The chain of entities and lots from the starting point of a raw material through intermediate processing, transfer, receipt and use in products.
- 2. Origin identification information: Information identifying a raw material, including biological species, part used, place of origin, collection or manufacturing period and manufacturing method.
- 3. Lot transformation: An operation that assigns a lot identifier different from the one at receipt through splitting, subdivision, mixing or repackaging.
- 4. Mass balance: A record showing the correspondence among quantities received, used, held in inventory, lost and discarded.
- 5. Bidirectional tracing: Both forward tracing from raw materials to the products in which they are used and backward tracing from products to the raw materials used.
Article 4 (Requirements)
- 1. For each raw material, the business operator shall identify the common name, source organism and part used, manufacturing or collection region, supplier, manufacturer and raw material specification. Materials of different origins shall not be grouped together solely on the basis of their names. Verification shall be conducted by confirming consistency among specifications, origin documentation, labeling at receipt and purchase order records.
- 2. The supply route shall be recorded in sequence from the manufacturer through trading intermediaries, transporters and entities performing subdivision to the receiving location. Handover dates, quantities, container identification and lot numbers for each entity shall be linked, and gaps in the route shall be checked across delivery notes, transport records, customs documentation or supplier attestations.
- 3. Where splitting, consolidation, subdivision or repackaging is performed, the lot numbers and quantities before and after transformation, the date, equipment and persons performing the operation shall be retained in a correspondence table. Where multiple raw material lots are consolidated into one, the constituent lot information shall not be deleted, and the relationship between inputs and outputs shall be verified using operational records and mass balances.
- 4. Acceptance decisions shall link the identity of the lot concerned, purity and other specifications established by the business operator, the certificate of analysis and transport conditions. The business operator shall establish specification values together with their supporting basis and shall record the applicable version. Where identity is established solely on the basis of supplier documentation, the reason for adopting that approach and the person responsible for verification shall be made clear.
- 5. During storage and issue, the raw material lot, storage area, status labeling, quantity, use-by date and manufacturing instruction number shall be recorded. The lot actually weighed shall be linked to the product lot without relying solely on the order of receipt. Verification shall be conducted by cross-checking inventory registers, weighing records and manufacturing records.
- 6. Where third-party testing is used, the raw material lot and group of containers represented by the collected sample shall be defined. Sampling records, sealing, handover and the certificate of analysis shall be linked by a single identifier. In accordance with JHFC-A-003, labeling shall not extend the scope of the test to other lots.
- 7. Where inability to trace, quantity discrepancies, replacement of labels or change notifications from suppliers are identified, the associated raw materials and products shall be placed on hold, and the affected scope, assessments and corrective actions shall be recorded. Traceability exercises shall verify whether all raw materials used can be reached from any selected product and whether all uses can be reached from any selected raw material.
Article 5 (Assessment Categories)
- Conformity: Origin, supply routes, lot transformations, quality documentation and the products in which the raw materials are used are linked in both directions, and the correspondence of quantities can be explained.
- Partial conformity: The principal genealogy can be verified, but supporting handover documentation or quantity records are insufficient, and the affected materials and products have been placed on hold with a corrective action plan in place.
- Nonconformity: The starting point or uses cannot be identified, there is no correspondence between lots before and after transformation, or materials are used without assessing discrepancies.
Article 6 (Implementation)
The business operator may make a self-declaration of conformity on the basis of the raw material genealogy register and the results of traceability exercises. Upon application, the Council may verify records in both directions for selected products or raw materials. Conformity with this Standard shall be reviewed when supply routes, processing conditions or identification methods change and during periodic checks.
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.