Contract Manufacturing and Accreditation Labeling Standard

JHFC-A-004　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 health foods, product planning, raw material procurement, manufacturing, packaging, testing and sales may be divided among multiple entities. When accreditation labeling alone is given prominence, the accredited entity, facility, processes and validity period become unclear, and the boundary with the seller's responsibilities becomes difficult to discern. This Standard is established to present the allocation of responsibilities and the scope of accreditation accurately while reconciling the disclosure of outsourcing relationships with the protection of confidential transaction information.

Article 1 (Purpose)

The purpose of this Standard is to clarify the correspondence between the entity responsible for the labeling and the actual subject of accreditation in relation to quality responsibilities, contractor management and accreditation labeling in the contract manufacturing of health foods, and to assess whether controls allow continued verification.

Article 2 (Scope)

This Standard applies to health foods for which processes relating to product quality, including raw material processing, mixing, filling, packaging, labeling, storage and testing, are outsourced. It includes subcontracting and covers domestic and overseas contractors. The scope of disclosure of factory names and similar information shall comply with JHFC-A-001.

Article 3 (Terms and Definitions)

• 1. Contract giver: The business operator that establishes product specifications and bears ultimate management responsibility for outsourced processes and labeling.
• 2. Contract acceptor: An entity that performs processes such as manufacturing, packaging, testing or storage under a contract.
• 3. Scope of accreditation: The scope of facilities, processes, product categories, specifications or activities stated in an accreditation certificate.
• 4. Subcontracting: An arrangement whereby the contract acceptor has another entity perform all or part of an outsourced process.
• 5. Quality agreement: A written agreement defining responsibilities, specifications and procedures for changes, deviations, records, audits and communication.

Article 4 (Requirements)

• 1. The contract giver shall enter into a quality agreement specifying, for each process, the entity performing it, responsibility for approval and the record holder. Responsibilities for establishing product specifications, making release decisions, approving labeling and handling complaints shall not be left unassigned. Verification shall be conducted by cross-checking contracts, responsibility allocation tables and actual approval records.
• 2. Before outsourcing begins and throughout its continuation, the suitability of the contract acceptor's equipment, hygiene controls, training, document control, lot tracing and testing arrangements for the outsourced processes shall be assessed. The business operator shall establish assessment methods and frequencies according to process risks and shall retain questionnaires, audit records, licensing and approval information or quality performance records as supporting evidence.
• 3. When accreditation is indicated in labeling, the accrediting body, type of accreditation, accredited entity and scope of accreditation shall be clearly stated. Accreditation of a facility shall not be presented in a manner that could be read as accreditation of the product or seller. Public information from the accrediting body, the subject covered in the accreditation certificate and the validity of the accreditation shall be cross-checked.
• 4. Where factory names, locations or accreditation numbers are not continuously made public for commercial reasons, the withheld items and reasons shall be controlled, and a contact point shall be established through which the fact and scope of accreditation can be verified upon inquiry. Response records shall be retained, and consistency with the arrangements for disclosure required by JHFC-A-001 shall be verified.
• 5. For subcontracting, the quality agreement shall specify the contract giver's prior approval, the scope of subcontracting and equivalent quality obligations. The contract giver shall maintain knowledge of the process chain and the accreditation status of each facility and shall verify that no unauthorized subcontracting occurs by using contractor lists, process diagrams and approval histories.
• 6. For changes in raw materials, processes, facilities, test methods, accreditation status or subcontractors, requirements for prior notification and impact assessment, and whether labeling revision is necessary, shall be defined. Upon learning of expiry, suspension or a change in scope, accreditation labeling shall be reviewed promptly, and actions concerning inventory, sales pages and literature shall be recorded.
• 7. In the event of a deviation, recall or complaint, the contract giver and contract acceptor shall share information on the lots concerned, communication channels, responsibility for investigation and responsibility for corrective action. The contract giver shall not close the matter solely on the basis of the contract acceptor's report, but shall verify the adequacy of the identified causes, actions taken and measures to prevent recurrence using approval records and lot tracing results.

Article 5 (Assessment Categories)

• Conformity: Responsibilities and subcontracting for all outsourced processes are controlled, and accreditation labeling is consistent with the accrediting body and scope.
• Partial conformity: Actual process controls can be verified, but some inquiry procedures or change records are insufficient, and a corrective action plan has been approved.
• Nonconformity: The responsible entity cannot be identified, unauthorized subcontracting occurs, or labeling extends beyond the subject of accreditation.

Article 6 (Implementation)

The contract giver may make a self-declaration of conformity on the basis of the contractor register, quality agreements and the results of cross-checking accreditation labeling. Upon application, the Council may verify supporting documentation after establishing arrangements for handling confidential information. Conformity with this Standard shall be reviewed when the outsourcing network, accreditation status or schemes change and during periodic reviews.

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.

← Back to Standards