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Regulations on Registration and Administration of Overseas Manufacturing Enterprises of Imported Food (AQSIQ Decree No. 145)

Chapter I General Provisions

Article 1 These Provisions are formulated in accordance with the provisions of the Food Safety Law of the People's Republic of China and its implementing regulations, the Law of the People's Republic of China on the Inspection of Import and Export Commodities and its implementing regulations in order to strengthen the supervision and management of foreign food production enterprises.

Article 2 These Provisions shall apply to the registration and supervision and administration of overseas production, processing and storage enterprises (hereinafter referred to as overseas production enterprises of imported food) that export food to China.

Article 3 The General Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as the General Administration of Quality Supervision and Quarantine) shall administer the registration of overseas production enterprises of imported food in a unified manner.

The State Accreditation and Accreditation Regulatory Commission (hereinafter referred to as the State Accreditation and Accreditation Regulatory Commission) organizes and implements the registration and supervision and administration of overseas production enterprises of imported food.

Article 4 The Catalogue for the Registration and Implementation of Overseas Manufacturing Enterprises of Imported Food (hereinafter referred to as the Catalogue) shall be formulated and adjusted by the State Accreditation and Supervision Commission and promulgated by the State Administration of Quality Supervision and Inspection.

The procedures and technical requirements for the registration and evaluation of different product categories in the Catalogue shall be formulated and promulgated separately by the State Accreditation and Supervision Commission.

Article 5 Foreign producers of food in the Catalogue shall be registered before their products can be imported.

Chapter II Registration Conditions and Procedures

Article 6 The conditions for registration of overseas production enterprises of imported foodstuffs are as follows:

(1) The veterinary service system, plant protection system and public health management system related to registration in the country (region) where the enterprise is located have been assessed to be qualified;

(2) Animal and plant raw materials for food exported to China shall come from non-epidemic areas; where there may be risks of animal and plant disease transmission in food exported to China, the competent authorities in the country (region) where the enterprise is located shall provide evidence documents and relevant scientific materials for risk elimination or controllability.

(3) Enterprises shall be approved by the relevant competent authorities in the country (region) where they are located and under their effective supervision, and their hygienic conditions shall conform to the relevant provisions of Chinese laws, regulations and standards and norms.

Article 7 In applying for registration, an overseas production enterprise of imported food shall recommend to the State Accreditation Regulatory Commission through the competent authority of its country (region) or other prescribed means, and submit a certificatory document meeting the requirements specified in Article 6 of these Measures, together with the following materials. The relevant materials submitted shall be in Chinese or English:

(1) Written information on laws and regulations concerning animal and plant epidemics, veterinary hygiene, public health, plant protection, pesticide and veterinary drug residues, registration management and hygiene requirements of food production enterprises in the host country (region), establishment of competent authorities in the host country (region), personnel situation and implementation of laws and regulations;

(2) List of overseas food production enterprises applying for registration;

(3) The assessment and reply of the competent authorities in the country (region) to the actual situation of quarantine and health control of the enterprises recommended by them;

(4) Statement by the competent authorities of the country (region) that the enterprises recommended by them conform to the requirements of Chinese laws and regulations;

(5) The application form for enterprise registration shall, when necessary, provide the plan of the factory area, workshop and cold storage, as well as the process flow chart.

Article 8 The State Accreditation Regulatory Commission shall organize relevant experts or designated institutions to examine the information submitted by the competent authorities or other prescribed methods in the countries (regions) where the overseas food production enterprises are located, and form an evaluation group to conduct on-the-spot evaluation according to the needs of the work. The members of the evaluation group shall be more than two.

Personnel engaged in evaluation shall be qualified by the State Accreditation and Supervision Commission.

Article 9 The evaluation team shall complete the evaluation work in accordance with the procedures and requirements of different product categories in the Catalogue and submit the evaluation report to the State Accreditation and Supervision Commission.

The State Accreditation Supervision Committee shall examine the evaluation report in accordance with its working procedures and make a decision on whether to register or not. If it meets the registration requirements, it shall be registered and notified in writing to the competent authorities of the country (region) where the overseas food production enterprises are located; if it is not registered, it shall notify in writing the competent authorities of the country (region) where the overseas food production enterprises are located and explain the reasons.

The State Accreditation and Supervision Commission shall regularly publish the list of registered overseas food production enterprises and report it to the State Administration of Quality Supervision and Inspection.

Article 10 The validity period of registration is four years.

Where an overseas food production enterprise needs to continue its registration, it shall, one year before the expiration of the validity period of registration, submit an application for continuation of registration to the State Accreditation and Supervision Commission through the competent authorities of its country (region) or other prescribed means.

If the application for renewal of registration is not filed within the time limit, the State Accreditation Supervision Commission shall cancel its registration and make a public announcement.

Article 11 When a registered foreign food production enterprise changes its registration matters, it shall inform the State Accreditation and Supervision Commission in a timely manner through the competent authorities of its country (region) or other prescribed means. The State Accreditation and Supervision Commission shall make corresponding treatment according to the specific changes and report them to the State Administration of Quality Supervision and Inspection.

Article 12 A registered overseas food production enterprise shall faithfully mark its registration number on the food packaging exported to China.

It is forbidden to use or transfer the registration number fraudulently.

Chapter III Registration Management

Article 13 The State Accreditation Regulatory Commission shall supervise and administer the overseas production enterprises of food in the Catalogue according to law, and organize relevant experts or designated agencies to conduct reexamination when necessary.

Article 14 Upon reexamination, it is found that it has been registered.