Promulgation Authorities:  General Administration of Customs

Promulgation Date:  2021.04.12

Effective Date:  2022.01.01

Validity Status:  valid

Document Number:  Order No. 248 of the General Administration of Customs

Administrative Provisions of the People's Republic of China on Registration of Overseas Manufacturers of Imported Food

Administrative Provisions of the People's Republic of China on Registration of Overseas Manufacturers of Imported Food

Order No. 248 of the General Administration of Customs

The Administrative Provisions of the People's Republic of China on Registration of Overseas Manufacturers of Imported Food, adopted upon deliberation at the executive meeting of the General Administration of Customs on March 12, 2021, are hereby promulgated, effective January 1, 2022. The Administrative Provisions on Registration of Overseas Manufacturers of Imported Food promulgated under the Order No. 145 of the former General Administration of Quality Supervision, Inspection and Quarantine on March 22, 2012, and revised pursuant to Order No. 143 of the General Administration of Customs on November 23, 2018 shall be repealed simultaneously.

Director: Ni Yuefeng

April 12, 2021

Administrative Provisions of the People's Republic of China on Registration of Overseas Manufacturers of Imported Food

Chapter I General Provisions

Article 1    These Provisions are enacted pursuant to the provisions of the Food Safety Law of the People's Republic of China and its Implementation Regulations, the Law of the People's Republic of China on Import and Export Commodity Inspection and its Implementation Regulations, the Law of the People's Republic of China on Inbound and Outbound Animal and Plant Quarantine and its Implementation Regulations, the Special Provisions of the State Council on Strengthening Supervision and Administration of the Safety of Products Including Food and related laws and administrative regulations for the purpose of strengthening administration of registration of overseas manufacturers of imported food,.

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

Overseas manufacturers of imported food referred to in the preceding paragraph shall exclude enterprises engaging in manufacturing, processing or storage of food additives and food-related products.

Article 3    The General Administration of Customs ("GAC") is responsible for administration of registration of overseas manufacturers of imported food on a unified basis.

Article 4    Overseas manufacturers of imported food shall be registered with the GAC.

Chapter II Conditions and Procedures for Registration

Article 5    Conditions of registration for an overseas manufacturer of imported food are as follows:

(I) The food safety management system of the country (region) where it is located has passed the equivalence assessment and examination by the GAC;

(II) It has been established with the approval of the competent authority of the country (region) where it is located and under the effective regulation thereof;

(III) It has established an effective food safety, hygiene management and protection system, lawfully manufactures and exports the food in the country (region) where it is located, and ensures that the food exported to China complies with the relevant laws and regulations and food safety standards of China; and

(IV) It complies with the relevant inspection and quarantine requirements agreed upon by the GAC and the competent authority of the country (region) where it is located.

Article 6    The registration methods for an overseas manufacturer of imported food include registration recommended by the competent authority of the country (region) where the enterprise is located and registration application filed by the enterprise.

The GAC shall determine the registration method and application materials of overseas manufacturers of imported food based on the analysis of factors such as raw material sources, manufacturing and processing techniques, historical food safety data, consumer groups, eating methods, etc. and taking into account international practices.

Upon risk analysis or where there is evidence showing that the risks of a certain type of food have changed, the GAC may adjust the registration method and application materials of the overseas manufacturers of the corresponding food.

Article 7    Overseas manufacturers of the following food shall be recommended by the competent authority of the country (region) where they are located to the GAC for registration: meat and meat products, sausages casing, aquatic products, dairy products, bird's nest and bird's nest products, bee products, eggs and egg products, edible fat and oil materials, stuffed pasta, edible grains, industrial products of grain flour and malt, fresh preserved and dehydrated vegetables and dried beans, condiments, nuts and seeds, dried fruits, unbaked coffee beans and cacao beans, special dietary food and health food.

Article 8    The competent authority of the country (region) where the enterprise is located shall examine and verify the enterprise recommended for registration, and upon confirming that it satisfies the registration requirements, the competent authority shall recommend the enterprise to the GAC for registration and submit the following application materials:

(I) a recommendation letter issued by the competent authority of the country (region) where it is located;

(II) a list of enterprises and an application for enterprise registration;

(III) identity certificates of the enterprise, such as the business license issued by the competent authority of the country (region) where the enterprise is located;

(IV) a statement made by the competent authority of the country (region) where the enterprise is located that the enterprise meets the requirements of these Provisions; and

(V) an examination report on the enterprise concerned issued by the competent authority of the country (region) where the enterprise is located.

When necessary, the GAC may require the enterprise to provide documents on the food safety, hygiene and protection system, such as the floor plans of the factory, workshop and cold storage of the enterprise, as well as the process flow chart, etc.

Article 9    An overseas manufacturer of food other than the food listed in Article 7 of these Provisions shall file an application for registration to the GAC by itself or by entrusting an agent, and submit the following application materials:

(I) an application for enterprise registration;

(II) identity certificates of the enterprise, such as the business license issued by the competent authority of the country (region) where it is located; and

(III) a statement that the enterprise undertakes to meet the requirements of these Provisions.

Article 10    The contents of the application for enterprise registration shall include the name of the enterprise, the country (region) where the enterprise is located, address of production premises, legal representative, contact person, contact information, registration number approved by the competent authority of the country (region) where it is located, and the type, production type and production capacity of the food to be registered.

Article 11    The application materials for registration shall be submitted in Chinese or English. Where the relevant country (region) and China have otherwise agreed on the registration method and application materials, such agreement shall prevail.

Article 12    The competent authority of the country (region) where it is located or the overseas manufacturer of imported food shall be responsible for the authenticity, completeness and legality of the materials it submits.

Article 13    The GAC shall organize by itself or by entrusting a relevant institution a review panel to conduct assessment and examination on the overseas manufacturer of imported food applying for registration by means of documentary inspection, video inspection, on-site inspection, etc. The review panel shall consist of two or more assessment examiners.

The overseas manufacturer of imported food and the competent authority of the country (region) where it is located shall assist in carrying out the aforesaid assessment and examination work.

Article 14    The GAC shall, according to the assessment and examination results, register the overseas manufacturer of imported food which meets the requirements, and issue a registration number in China, and notify the competent authority of the country (region) where it is located or the overseas manufacturer of imported food in writing; it shall not register the overseas manufacturer of imported food which does not meet the requirements, and notify the competent authority of the country (region) where it is located or the overseas manufacturer of imported food in writing.

Article 15    When a registered enterprise exports food to China, it shall indicate its registration number in China or the registration number approved by the competent authority of the country (region) where it is located on the interior and exterior packing of the food.

Article 16    The registration of an overseas manufacturer of imported food shall be valid for five years.

The GAC shall, when registering an overseas manufacturer of imported food, determine the commencement and termination dates of the registration validity period.

Article 17    The GAC shall announce the list of registered overseas manufacturers of imported food in a unified manner.

Chapter III Registration Administration

Article 18    The GAC shall organize a review panel on its own or entrust the relevant institutions to conduct a review on whether the overseas manufacturer of imported food consistently satisfies the registration requirements. The review panel shall comprise two or more assessment examiners.

Article 19    Where the registration information of an overseas manufacturer of imported food changes during the validity period of registration, an application for change shall be submitted to the GAC through registration application and the following materials shall be submitted:

(I) a table of comparison for information on change of registration matters; and

(II) evidentiary materials relating to the information change.

The GAC shall make the change if it deems that the change may be made upon assessment.

In case of relocation of production site, change of legal representative or change of registration number granted by the country (region) where the enterprise is located, re-application for registration shall be made and the registration number in China shall be invalidated automatically.

Article 20    Where an overseas manufacturer of imported food needs to renew the registration, it shall, within three to six months before the expiry of the validity period of registration, file an application for renewal of registration to the GAC through registration application.

The application materials for renewal of registration shall include:

(I) an application for renewal of registration; and

(II) a statement on continuing to meet the registration requirements.

The GAC shall renew the registration of enterprises that meet the registration requirements, and the validity period of the registration shall be extended by five years.

Article 21    Where a registered overseas manufacturer of imported food falls under any of the following circumstances, the GAC shall cancel its registration, notify the competent authority of the country (region) where it is located or the overseas manufacturer of imported food, and make an announcement:

(I) The manufacturer fails to apply for renewal of registration as required;

(II) The competent authority of the country (region) where the enterprise is located or the overseas manufacturer of imported food voluntarily applies for deregistration; or

(III) The manufacturer no longer meets the requirements of Item (II) of Article 5 of these Provisions.

Article 22    The competent authority of the country (region) where an overseas manufacturer of imported food is located shall implement effective regulation over the registered enterprise, and urge the registered enterprise to continuously meet the registration requirements. If it is found that the overseas manufacturer of imported food does not meet the registration requirements, control measures shall be taken immediately to suspend the enterprise's export of food to China until it meets the registration requirements after rectification.

If the overseas manufacturer of imported food finds on its own that it does not meet the registration requirements, it shall take the initiative to suspend the enterprise's export of food to China and immediately take rectification measures until it meets the registration requirements after rectification.

Article 23    If the GAC finds that a registered overseas manufacturer of imported food no longer meets the registration requirements, it shall order the overseas manufacturer to make rectification within a prescribed time limit, and suspend the enterprise's import of food during the period of rectification.

If the import of an enterprise recommended by the competent authority of the country (region) where it is located is suspended, the competent authority shall supervise the enterprise concerned to complete rectification within a prescribed time limit, and submit a written rectification report and a written statement on compliance with the registration requirements to the GAC.

If the import of an enterprise that applies for registration by itself or by entrusting an agent is suspended, the enterprise shall complete rectification within a prescribed time limit, and submit a written rectification report and a written statement on compliance with the registration requirements to the GAC.

The GAC shall examine the rectification of the enterprise, and resume the enterprise's import of food if the enterprise passes the examination.

Article 24    If a registered overseas manufacturer of imported food falls under any of the following circumstances, the GAC shall revoke its registration and make an announcement:

(I) Causing major food safety accidents to imported food due to the fault of the enterprise;

(II) Being found to have food safety problems in entry inspection and quarantine of the food exported to China, where the circumstances are serious;

(III) Having major problems in its food safety and hygiene management, unable to ensure that the food exported to China meets the safety and hygiene requirements;

(IV) Failing to meet the registration requirements after rectification;

(V) Providing false materials or concealing the relevant information;

(VI) Refusing to cooperate with the GAC in reexamination and accident investigation; or

(VII) Leasing, lending, transferring, reselling at a profit, or fraudulently using the registration number.

Chapter IV Supplementary Provisions

Article 25    Where an international organization or the competent authority of a country (region) exporting food to China has issued an epidemic notice, or serious problems such as epidemic or public hygiene incidents are found in entry inspection and quarantine of the relevant food, the GAC shall make an announcement on suspending the import of the relevant food from the said country (region), and shall not accept the application for registration of the relevant food from the said country (region) during the aforesaid period.

Article 26    The competent authority of the country (region) where the overseas manufacturer of imported food is located shall refer to the official authority responsible for regulation of food safety and hygiene of the country (region) where the overseas manufacturer of imported food is located.

Article 27    The power to interpret these Provisions shall remain with the GAC.

Article 28    These Provisions shall come into force as of January 1, 2022, repealing simultaneously the Administrative Provisions on Registration of Overseas Manufacturers of Imported Food promulgated under the Order No. 145 of the former General Administration of Quality Supervision, Inspection and Quarantine on March 22, 2012, and revised in accordance with the Order No. 243 of the GAC on November 23, 2018.