GACC Decree 248: Overseas Food Manufacturer Registration Procedure

The 18 high-risk categories requiring authority-routed registration

Decree 248 distinguishes high-risk product categories (where the Japanese competent authority must route the application to GACC) from lower-risk categories (where self-registration through the Chinese importer is acceptable). The high-risk list includes:

• Meat and meat products
• Casings (sausage casings)
• Aquatic products
• Dairy products
• Bird's nest and bird's nest products
• Bee products
• Eggs and egg products
• Edible oils and fats, and oilseeds
• Stuffed pastry products
• Grains intended for human consumption
• Industrial grain products and malt
• Fresh and dried vegetables, and dried beans
• Condiments / seasonings
• Nuts and seeds
• Dried fruits
• Unroasted coffee beans and cocoa beans
• Special dietary foods (infant formula, special medical purpose food, etc.)
• Functional food / health food

Japan-origin OEM food for China most commonly falls into the seasonings, dried fruit, nuts/seeds, bee products, and functional food categories. Confectionery, beverages, and many prepared foods outside the high-risk list use the self-registration route.

The authority-routed application (high-risk categories)

Step 1 — Identify the Japanese competent authority

Different product categories are routed through different Japanese authorities:

• MHLW (Ministry of Health, Labour and Welfare) — most processed food, seasonings, supplements, and health food.
• MAFF (Ministry of Agriculture, Forestry and Fisheries) — meat, dairy, fishery products, grain/cereal, bee products.
• Consumer Affairs Agency — special dietary foods.

The Japanese OEM factory or its trade association engages the competent authority, which collects the application dossier and forwards it to GACC.

Step 2 — Prepare the dossier

The dossier varies by category but typically includes:

• Application form completed by the Japanese OEM factory.
• Business licence / corporate registration of the Japanese factory.
• Facility floor plan with production line indication.
• Process flow diagram for each product category covered.
• HACCP plan (in Japanese with English summary, or in English).
• List of major raw material suppliers.
• Quality management system documentation (ISO 22000 / FSSC 22000 commonly referenced).
• Evidence of competent authority oversight — typically the Japanese food sanitation business permit and inspection history.
• Photos of facility, production lines, finished-product storage, and quality control laboratory.

Step 3 — Submission and review

The Japanese competent authority compiles and forwards the dossier to GACC. GACC reviews and, in some cases, conducts remote or on-site inspection. Approval is typically 4–9 months from forwarded submission, longer for novel categories or first-time Japanese applicants.

Step 4 — Registration confirmation

On approval, GACC issues a registration number specific to the product category. The number must appear on the packaging or accompanying documentation of each shipment to China — failure to display the number results in shipment refusal at GACC customs.

The self-registration route (lower-risk categories)

For categories outside the 18-category high-risk list, the Chinese importer self-registers the overseas manufacturer through the GACC online system. The dossier is lighter:

• Business licence of the overseas manufacturer.
• Production scope statement.
• Quality management system evidence (HACCP / ISO 22000 / FSSC 22000).
• Importer's confirmation of supplier qualification.

Self-registration is typically confirmed within 5–15 working days. The registration number is generated by the system and used for customs declaration.

Category coverage — one factory, multiple products

Registration is by facility and by category. A Japanese OEM factory producing both confectionery (self-registration category) and seasonings (high-risk category) needs:

• One self-registration for the confectionery category, handled by the Chinese importer.
• One authority-routed registration for the seasonings category, handled by MHLW + GACC.

Each category registration is tracked independently. Adding a new category later requires a new application — extending the existing registration is not possible.

Renewal and ongoing obligations

• 5-year validity from initial approval. Renewal application must be filed at least 6 months before expiry — late filings result in registration lapse and the need for fresh application.
• Change notification — material changes to facility, ownership, manufacturing process, or product range must be notified to GACC (via the Japanese competent authority for the authority-routed registrations).
• Annual self-declaration — the manufacturer confirms continued compliance with the basis on which registration was approved.
• Cooperation with GACC inspection — remote and on-site inspections may occur during the registration period.

Common stumbling points for Japanese OEM factories

• English documentation gaps. Most facility and QA documentation in Japan is in Japanese. GACC expects English summaries at minimum. Budget translation time into the project plan.
• HACCP plan format. Japanese HACCP documentation is often built around the Japanese Food Sanitation Act framework. GACC prefers Codex-aligned HACCP presentation. Restructure where necessary.
• Forgetting to display the registration number.The registration number must appear on packaging or in the customs documentation. Suppliers focused on their domestic Japanese SKUs sometimes omit it from China-bound shipments.
• Renewal lapse. 5-year cycle is easy to forget. Calendar the renewal at the time of approval; aim to file 12 months before expiry as buffer.