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Registration and Administration of Overseas Manufacturers of Imported Food

Regulations of the People's Republic of China on the Registration and Administration of Overseas Manufacturers of Imported Food

                      Chapter I General Provisions

Article 1 To strengthen the registration management of overseas manufacturers of imported foods, these  Regulations are formulated in accordance with 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 Import and Export Commodity Inspection and its implementing regulations, the Law of the People's Republic of China on the Entry and Exit Animal and Plant Quarantine and its implementation regulations, the Special Provisions of the State Council on Strengthening the Supervision and Administration of Food and Other Products Safety, as well as relevant administrative regulations.

Article 2 These Regulations apply to the registration management of overseas manufacturers of production, processing, and storage (hereinafter referred to as “overseas manufacturers of imported foods”) that export foods to China. The overseas manufacturers of imported foods mentioned in the above paragraph do not include manufacturers engaging in the production, processing, and storage of food additives and food-related products.

Article 3 The General Administration of Customs of the People’s Republic of China (GACC) is responsible for the registration management of overseas manufacturers of imported foods.

Article 4 Overseas manufacturers of imported foods shall obtain registration with   the GACC.

Chapter II Conditions and Procedures for Registration

Article 5 The registration conditions for overseas manufacturers of imported foods are as follows:

1. The food safety management system of the country/region where the manufacturer is located has passed GACC’s equivalence assessment and/or review;

2. The manufacturer was established with approval by the competent authority of the country/region, and the manufacturer is under effective regulation by the competent authority;

3. The manufacturer has an established, effective food safety and sanitation management system and protection system, legally produces and exports food in the country/region, and ensures that foods exported to China comply with relevant Chinese laws, regulations, and national food safety standards;

4. Food exporting to China conforms with relevant inspection and quarantine requirements that have been agreed upon after discussion by the GACC and the competent authorities of the country/region.

Article 6 Registration of overseas manufacturers of imported foods include recommendation for registration by competent authority of the country/region, and application for registration by a manufacturer. The GACC, based on analysis of various factors, including sources of raw materials,  production and processing technologies, historical data about food safety, consumer groups, consumption methods of food, and in consideration of international practices, determines the method for registration of overseas manufacturers of imported food and

the required application materials. If risk analysis or evidence presents that risks of a certain category of food has

changed, GACC may adjust the registration method and required application materials for overseas manufacturers of the corresponding food.

Article 7 Overseas manufacturers of the following foods shall be recommended by the competent authorities of their countries/regions to the GACC for registration: meat and meat products, casings, aquatic products, dairy products, bird’s nests and bird’s nest products, bee products, eggs and egg products, edible oils and fats, oilseeds, stuffed pastry products, edible grains, milled grain industry products and malt, fresh and dehydrated vegetables and dried beans, condiments, nuts and seeds, dried fruits, unroasted coffee beans and cocoa beans, foods for special dietary purposes, and functional foods.

Article 8 The competent authority of the country/region shall examine and inspect the manufacturer to be recommended for registration; after confirming that the manufacturer conforms with the registration requirements, the competent authority of the country/region recommends the producer to the GACC for registration, and submits the following application materials:

1. Letter of recommendation by the competent authority of the country/region; 

2. List of recommended manufacturers and the manufacturers’ applications for registration; 

3. Documents certifying identification of the manufacturer, such as the business license issued by the competent authority of the country/region; 

4. Statement that the producer recommended by the competent authority of the country/region conform with requirements of these Regulations;  

5. Reports of examinations/inspections/review conducted by the competent authority  of the country/region to relevant manufacturers. If necessary, the GACC may request documents related to the manufacturer’s food

safety, sanitation, and protection system, such as floor plans of the factory/workshops/cold storages, and the processing flow chart and others.

Article 9 Overseas manufacturers of foods other than those listed in Article 7 of these Regulations shall, by themselves or by agents, file applications for registration with the GACC and submit the following application materials:

1. Manufacturer’s application for registration;

2. Documents certifying the identification of the manufacturer, such as business license issued by the competent authority of the country/region;

3. Statement by the manufacturer that it conforms with requirements of these Regulations.

Article 10 The application for manufacturer registration shall contain the following information: the name of the manufacturer, country/region where the manufacturer is located, address of the production site, legal representative, contact person, contact information, registration number approved by the competent authority of the country/region, the type of food for registration, type of production, and production capacity, etc.

Article 11 The application materials for manufacturer registration shall be submitted in Chinese or English. If relevant country /region and China have separate agreements on registration method and application materials, registration shall be carried out following the agreement. 

Article 12 Competent authority of the country /region or overseas manufacturers of imported foods shall be held accountable for truthfulness, completeness, and legality of the submitted materials.

Article 13 The GACC or GACC entrusted institutions, set up a review team to conduct evaluations and reviews of the overseas manufacturers applying for registration. The evaluation is conducted in forms of document review, video inspection, and/or on-site inspection. A review team is composed of two or more reviewers. Overseas manufacturers of imported foods and the competent authorities of the country/ region shall assist the GACC in carrying out the aforementioned evaluation and review.

Article 14 The GACC shall, based on the evaluation and review, register the overseas manufacturers that meet the requirements, and grants them Chinese registration numbers; and shall notify the competent authority of the country/region or the overseas manufacturers in writing of the registration. The GACC shall decline the registration of overseas manufacturers that do not meet the requirements and notify the competent authority of the country/region or the overseas manufacturers in writing of the denial. 

Article 15 A registered manufacturer shall mark the Chinese registration number or the registration number approved by the competent authority of the country/region on the inner and outer packaging of the foods exported to China.  

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