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Regulations of the People's Republic of China on the Administration of the Registration of Overseas Food Production Enterprises for Import (Order No. 280 of the General Administration of Customs)

Issue Date:2025-10-20 Source:GACC Scan QrCode to View

 

 

(Promulgated by Order No. 280 of the General Administration Customs on October 14, 2025, effective from June 1, 2026)

Chapter I General Provisions

Article 1 These Regulations are formulated in accordance with 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 implementing regulations, the Special Rules of the State Council on Strengthening the Supervision and Management of the Safety of Food and Other Products, and other relevant laws and administrative regulations, with a view to strengthening the administration of the registration of overseas food production enterprises for import.

Article 2 These Regulations apply to the administration of the registration of overseas enterprises engaged in the production, processing, and storage of food exported to China (hereinafter collectively referred to as overseas food production enterprises for import).

The term "overseas food production enterprises for import" as defined in the preceding paragraph does not include enterprises involved in the production, processing, and storage of food additives and food-related products.

Article 3 The General Administration of Customs of China (hereinafter referred to as the GACC) is responsible for the unified administration of the registration of overseas food production enterprises for import.

Article 4 Overseas food production enterprises for import shall register with the GACC.

Article 5 In accordance with risk management principles, the GACC implements a categorized management system for overseas food production enterprises for import. This system is established following its assessment and review of the food safety management systems and conditions in the manufacturers' respective countries (regions), and by considering the risk levels of the imported foods. It specifies the corresponding registration methods, application materials, review procedures, and other registration requirements.

Should risk assessments or evidence indicate changes in imported food safety risks, the GACC may adjust the relevant registration management requirements.

Chapter II Registration Conditions and Procedures

Article 6 The GACC shall formulate and announce the catalog of imported foods that require official recommendation for registration (hereinafter referred to as the catalog). This determination will be based on an analysis of factors such as raw material sources, production and processing techniques, historical food safety data, consumer demographics, and consumption methods, in conjunction with international practices.

Article 7 Registration Conditions for Overseas Food Production Enterprises for Import:

(1) Established with the approval of, and operating under the effective supervision of, the competent authority of the country (region) concerned;

(2) Possessing an effective food safety and hygiene management and defense system, conducting lawful production and export activities within the country (region) concerned, and ensuring that food products exported to China comply with relevant Chinese laws, regulations, and national food safety standards;

(3) Meeting the inspection and quarantine requirements mutually agreed upon by the GACC and the competent authority of the country (region) concerned.

For overseas food production enterprises for import whose food products are listed in the catalog, a recommendation from the competent authority of their country (region) concerned is also required

Article 8 The competent authority of the country (region) where overseas food production enterprises for import listed in the catalog are located shall conduct review and inspection of these enterprises and, for those meeting the registration requirements, issue review and inspection reports and recommendation letters.

Article 9 Overseas food production enterprises for import shall submit the following application materials to the GACC, either directly or through their authorized agents:

(1) Enterprise registration application information;

(2) Enterprise identity documents, such as business licenses or other certificates issued by the competent authority of the country (region) concerned;

(3) A declaration by the enterprise committing to comply with the requirements of these Regulations.

Overseas food production enterprises for import listed in the catalog shall also submit review and inspection reports and recommendation letters issued by the competent authority of the country (region) concerned.

When necessary, the GACC may require enterprises to provide materials concerning their food safety, hygiene and protection systems, production types, production capacity, among others.

Article 10 Enterprise registration application information shall include the enterprise name, country (region) of establishment, production site address, legal representative, contact person, contact details, the registration number approved by the competent authority of the country (region) concerned, the food categories applied for registration, and other relevant information.

Article 11 Registration application materials shall be in Chinese or English.

The competent authorities of the countries (regions) concerned and overseas food production enterprises for import shall be responsible for the authenticity, completeness, and legality of the relevant materials.

Article 12 The GACC will, based on the safety risk level of imported food, conduct an assessment and review of overseas food production enterprises for import seeking registration. This assessment and review may be carried out either independently or through commissioned relevant institutions, utilizing methods such as documentary examination, video inspection, and on-site inspection, or any combination thereof.

Overseas food production enterprises for import and the competent authorities of their respective countries (regions)shall cooperate with the aforementioned assessment and review.

Article 13 Based on assessment and review results, the GACC will register overseas food production enterprises for import that meet the requirements and assign them registration numbers in China. A written notification will be issued to these registered enterprises. For enterprises that do not meet the requirements, registration will be denied, and the GACC will notify them in writing accordingly.

Article 14 Enterprises that have obtained registration shall, when exporting food to China, label on the food packaging either their registration number for China or the registration number approved by the competent authority of their country (region).

Article 15 The registration validity period for overseas food production enterprises for import is 5 years.

The GACC shall, when granting registration to overseas food production enterprises for import, determine the start and end dates of the registration validity period.

Article 16 The GACC shall publish a unified list of registered overseas food production enterprises for import.

Article 17 Where the food safety management system of the country (region) of overseas food production enterprises for import is recognized by the GACC and meets one of the following circumstances, the GACC may agree in writing with the competent authority of that country (region) to adopt a list-based registration approach for their enterprises:

(1) An import and export food safety cooperation agreement has been signed with the GACC;

(2) Cooperation documents, including agreements, memoranda, or joint declarations, covering food safety cooperation, have been signed with China;

(3) Other circumstances where the GACC, after risk assessment, deems a list-based registration approach appropriate.

Article 18 For list-based registration, the competent authority of the country (region) concerned shall submit the following materials to the GACC:

(1) A list of food production enterprises recommended for registration in China;

(2) The application information specified in Article 10 of these Regulations;

(3) A declaration affirming that the recommended enterprises comply with the first paragraph of Article 7 of these Regulations;

(4) A declaration committing to continuously fulfill the responsibilities stipulated in bilateral cooperation documents.

After review, the GACC shall register enterprises on the list that meet requirements and assign them a registration number for China. For those that do not meet requirements, registration shall be denied, and the competent authority of the country (region) concerned shall be notified in writing.

Chapter III Supervision and Management

Article 19 The GACC will, based on the food safety risk level of imported products, independently or by entrusting relevant institutions, conduct re-evaluations to determine whether overseas food production enterprises for import continuously meet their registration requirements.

Overseas food production enterprises for import and the competent authorities of their respective countries (regions) shall cooperate with the aforementioned re-evaluation efforts.

Article 20 During the registration validity period, should there be any changes to the registration information of an overseas food production enterprises for import, an application for modification shall be submitted to the GACC via the designated application channels, along with the following materials:

(1) Comparative table of modified registration particulars;

(2) Supporting documents related to the modified information.

Upon evaluation, the GACC shall approve the modifications. However, in cases where circumstances such as production site relocation, a change in the legal representative, or an alteration to the registration number issued by the competent authority of the country (region), where the establishment is located, have a significant impact on the establishment's food safety and hygiene management and control system, the GACC shall deny the modification and notify the establishment to re-apply for registration, and its registration number in China shall be invalidated as of the date of notification.

Article 21 The registration of an enterprise shall be automatically renewed for a period of five years upon the expiration of its validity, except under any of the following circumstances:

(1) The imported food is included in the list of imported foods ineligible for automatic renewal of registration;

(2) The enterprise is undergoing a rectification period due to non-compliance with registration requirements;

(3) The GACC has, in accordance with the law, suspended imports of relevant foods from the country (region) where the overseas food production enterprise for import is located.

The list of imported foods ineligible for automatic renewal of registration, as referred to in Item (1) of the preceding paragraph, shall be separately published by the GACC.

Article 22 Overseas food production enterprises for import listed on the non-automatic renewal registration list, if requiring registration renewal, shall submit an application for renewal of registration to the GACC through the designated application channels within 3 to 12 months prior to the expiration of the registration validity period. The application materials for renewal of registration shall include:

(1) Information for the application for renewal of registration;

(2) A declaration attesting to continuous compliance with registration requirements;

(3) Overseas food production enterprises for import listed in the catalog shall also provide a declaration issued by the competent authority of the country (region) concerned confirming ongoing compliance with registration requirements.

The GACC shall grant renewal of registration to enterprises that meet the registration requirements, extending the registration validity period by 5 years.

Article 23 The GACC shall revoke the registration of a registered overseas food production enterprise for import, notify the said enterprise, inform the competent authority of the country (region) concerned, and make a public announcement, if any of the following circumstances occurs:

(1) Failure to apply for renewal of registration as required;

(2) The competent authority of the country (region) concerned or the food overseas production enterprise for import voluntarily applies for cancellation;

(3) The enterprise is no longer meets the requirements specified in Article 7, Paragraph 1, Item (1) of these Regulations.

Article 24 The competent authorities of the countries (regions) where overseas food production enterprises for import are located shall bear responsibility for food safety supervision, effectively supervise registered enterprises, and ensure their continuous compliance with registration requirements. Upon discovering non-compliance with registration requirements, they shall immediately implement risk prevention and mitigation measures, suspend exports of food to China from the enterprises concerned, report to the GACC, and overseas enterprise rectification until compliance with registration requirements is achieved.

When overseas food production enterprises for import discover non-compliance with registration requirements, they shall proactively suspend food exports to China and immediately implement corrective actions until compliance with rectification requirements is achieved.

Article 25 Should the GACC discover that a registered overseas food production enterprise for import no longer meets the registration requirements, it shall order the producer to rectify within a specified period. Furthermore, it shall notify the competent authority of the country (region) concerned to oversee the rectification, and food imports from the enterprise concerned shall be suspended during the rectification period.

Upon completion of rectification by the enterprise, a supervisory rectification report and a written declaration of compliance with the registration requirements, issued by the competent authority of the country (region) concerned, shall be submitted.

The GACC shall review the enterprise's rectification status. If the requirements are met, food imports from the enterprise concerned shall be resumed.

Article 26 When the GACC suspends or resumes food imports from registered overseas food production enterprises for import in accordance with Articles 24 and 25 of these Regulations, the lists of such enterprises shall be published by the GACC.

Article 27 The GACC shall revoke and publicly announce the registration of a registered overseas food production enterprise for import under any of the follow circumstances:

(1) Major food safety incidents occur in imported food due to reasons attributable to the enterprise;

(2) Food exported to China is found to have serious food safety issues during entry inspection and quarantine;

(3) Significant deficiencies in the enterprise's food safety and hygiene management render it unable to ensure that food exported to China complies with safety and hygiene requirements;

(4) The enterprise fails to meet registration requirements even after rectification;

(5) The enterprise provides false information or conceal material facts;

(6) The enterprise refuses to cooperate with the GACC in conducting re-inspections or incident investigations;

(7) The enterprise leases, lends, transfers, resells, or illicitly uses its registration number;

(8) The enterprise's registration was granted despite its failure to meet the required application qualifications or registration conditions;

(9) Any other circumstances that lawfully warrant the revocation of registration.

Chapter IV Supplementary Provisions

Article 28 When the GACC lawfully suspends the importation of relevant food from a country (region) where overseas food production enterprises for import are located, applications for registration from food production enterprises in that country (region) shall not be accepted during the suspension period.

Article 29 Should a country (region) have separate agreements with China regarding the management of the registration of overseas food production enterprises for import, such agreements shall be followed.

Article 30 The scope of overseas food storage enterprises for import subject to registration management pursuant to these Regulations shall be separately announced by the GACC.

The management of the registration of overseas enterprises producing primary edible agricultural products shall be separately stipulated by the GACC.

Management requirements for overseas enterprises producing imported food for cross-border e-commerce retail shall be governed by relevant regulations.

Article 31 For the purpose of these Regulations, the "competent authorities of the countries (regions) concerned" refers to the official departments in the countries (regions) where overseas food production enterprises for import are located, which are responsible for the safety and hygiene supervision of food production enterprises .

Article 32 These Regulations shall be interpreted by the GACC.

Article 33 These Regulations shall come into effect on June 1, 2026. Simultaneously, the Regulations of the People's Republic of China on the Administration of the Registration of Overseas Food Production Enterprises for Import, promulgated by Order No. 248 of the General Administration of Customs on April 12, 2021, shall be repealed.

 

 


Disclaimer:The above content is translated from Chinese version of GACC. The GACC version shall prevail.