Guidance on Registration of Overseas Food Manufacturers with China CNCA

Regulatory Basis

According to the Food Safety Law, overseas food manufacturers whose products are exported to China should be registered with the national entry-exit inspection and quarantine department, namely AQSIQ.

Registration Rule

Administrative Provisions on Registration of Overseas Manufacturers of Imported Foods (AQSIQ Order No.145-2012)

Competent Authority

AQSIQ manages the registration work of overseas food manufacturers. CNCA is entrusted by AQSIQ to carry out detailed registration issues of overseas food manufacturers.

Who is the Applicant?

It’s already very clear overseas food manufacturers should be the responsible persons who need to apply for and finish the registration. To require registration of all overseas food manufacturers at the same time is not feasible. Therefore, AQSIQ takes a batch-wise approach by maintaining and updating a list called the “Implementation Catalogue of Registration of Overseas Manufacturers of Imported Foods”. For products listed in the Catalogue, their manufacturers should be CNCA-reviewed and approved prior to export to China.

Currently the Catalogue includes the following four product categories:

1. Meat

2. Aquatic products;

3. Dairy products;

4. Cubilose products

Implementation Catalogue of Registration of Overseas Manufacturers of Imported Foods (by 21 Dec 2015)

Conditions for Applying for CNCA Registration

• The veterinary service system, plant protection system and public sanitary management system of the country (region) where the manufacturer is located, in connection with the registration, have been evaluated for qualification;

• The animal and plant raw materials used in the food exported to China shall come from a non-diseased area; when exporting foods with possible risks of spreading animal or plant diseases to China, the competent authorities of the country (region) shall provide certification documents and relevant scientific evidence indicating that the risks have been eliminated or are under control.

• The manufacturer shall be approved by relevant competent authorities of the country (region), and under the effective control and surveillance of such authorities; the sanitary conditions of the manufacturer shall meet relevant provisions of the laws and regulations, standards and codes of China.

CNCA shall organize relevant experts or designate institutions to review the materials submitted by the competent authorities of the country (region), and establish a review panel to conduct on-site review according to the actual job demands. The review panel shall follow the review procedures and requirements of different product types in the Catalogue and then submit a review report to CNCA. Then, CNCA shall evaluate the review the report according to working procedures to decide whether the applicant can be registered. If approved, the applicant shall be registered by written notice to the competent authorities of the country (region); if the registration is not approved, a written notice, with reasons, shall be sent to the competent authorities of the country (region).

When an overseas manufacturer of imported food applies for registration, it shall be recommended by the competent authorities of the country (region) where the manufacturer is located or in other form as required by CNCA.

Preparation of CNCA Registration Dossiers

List of documents

The manufacturer should apply for registration via its competent authority and submit dossiers to CNCA via the authority, by mail or on-line.

Tips for preparing registration dossiers:

• The dossiers should be in English or Chinese instead of other languages;

• If the document needs the signature of the responsible person and seal of competent department, this information should not be absent;

• The manufacturer should carefully read every sentence especially questions in the application form, which should be well addressed;

• Submitted dossiers should be complete and consistent as requested;

Different types of manufacturers have different documents to fill out and submit. CNCA published templates here for dairy, meat, aquatic products and cubilose manufacturers respectively.

Procedures of CNCA Registration

Step 1: application

Fill out the application form of the overseas manufacturer of imported foods

Step 2: self-evaluation

When a manufacturer applies for registration, the authority in its country who is in charge of food safety and sanitary control should fill out the Questionnaire of the Overseas Manufacturer Registration Management for Exporting Food Products to China. In the meantime, the manufacturer should conduct self-check according to the questionnaire.

Step 3: CNCA acceptance

CNCA organizes expert panel to carry out formal examination on materials submitted and give feedback. If the materials are not unqualified, CNCA informs the applicant of correction or rejects application. The feedback document is sent to the foreign embassy in China.  

Step 4: Review and Examination

1)    Document review

CNCA will organize an import registration expert panel, which will review dossiers submitted and form a conclusion on whether to conduct audit of the overseas factory.

2)    On-site audit

During the process, the expert panel will evaluate and verify the overseas competent authority’s registration management of food manufacturers, its review and accreditation system of Chinese regulations/standards and its procedure of CNCA registration recommendation. Meanwhile, they will conduct spot-check on manufacturers regarding the implementation status of relevant regulations/standards.

3)    Form review report

The expert panel should form a preliminary review report within 60 days after the on-site audit. The report includes the validation result of the registration management system of food manufacturers, review and accreditation system of Chinese regulations/standards as well as procedure of CNCA registration recommendation of the exporting country, sanitary control conditions of audited manufacturers and their existing problems, suggestions for approval or not, etc.

4)    Examination

The import registration expert panel will review the preliminary review report and give feedback to the registration management department of CNCA.

After communicating with the overseas competent authority and listening to its opinions, the department will form a final review report. Within 15 days, CNCA informs the foreign competent authority of approved manufacturers, to-be-approved manufacturers with rectification suggestions or those cannot be registered.

If one manufacturer is approved, it may still face the following conditions:

1)    Modification

The manufacturer should notify CNCA of changed items related with registration via its competent authority;

2)    Suspension

CNCA will implement on-going monitoring on these approved manufacturers and organize expert panel to carry out re-audit if necessary. If the approved manufacturer is identified with problems during the re-audit or their products exported to China are found unqualified during post-market inspection, they will be suspended until the problem is fixed.

3)    Cancellation

The validity period of registration lasts for four years. The manufacturer shall apply for renewal of registration to the CNCA via the competent authority in its country within one year before it expires. Otherwise, CNCA will revoke the accreditation of the manufacturer.

4)    Revocation

CNCA will revoke the accreditation of the overseas manufacturer under the circumstances that big food safety accidents occur, serious product safety problems found during CIQ import inspection, etc.

List of approved manufacturers

CNCA made a specific page for overseas registered food manufacturers (click here to see).

Contact information of CNCA

The registration management department of CNCA

• TEL: 010-82262760

• EMAIL: [email protected]