General Administration of Quality Supervision, Inspection and Quarantine "Food Production License Management Measures" (General Administration Order No. 129)

　　No. 129

　　The "Measures for the Administration of Food Production Licensing" have been reviewed and approved at the bureau meeting of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on March 10, 2010, and are hereby promulgated, effective from June 1, 2010.

　　Director General

　　April 7, 2010

　　Measures for the Administration of Food Production Licensing

　　Chapter 1 General Provisions

　　Article 1 To ensure food safety, strengthen supervision of food production, and regulate food production licensing activities, these Measures are formulated in accordance with the "Food Safety Law of the People's Republic of China" and its implementing regulations, as well as laws and regulations on product quality and production licensing.

　　Article 2 Within the territory of the People's Republic of China, enterprises engaged in food production activities and quality and technical supervision departments implementing food production licensing must comply with these Measures.

　　Article 3 Enterprises shall not engage in food production activities without obtaining a food production license.

　　Article 4 The General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (hereinafter referred to as the General Administration of Quality Supervision) is responsible for the national management of food production licensing within its scope of duties.

　　Local quality and technical supervision departments at or above the county level are responsible for the management of food production licensing within their administrative regions within their scope of duties.

　　Article 5 Food production licensing must be strictly implemented in accordance with the procedures and requirements prescribed by laws, regulations, and rules, following the principles of openness, fairness, justice, and convenience.

　　Chapter 2 Procedures

　　Article 6 To establish a food production enterprise, the name must be pre-approved by the industrial and commercial department, and a food production license must be obtained in accordance with food safety laws, regulations, and the relevant requirements of these Measures.

　　Article 7 Local quality and technical supervision departments at or above the county level are the implementing agencies for food production licensing, except for food production licenses implemented by the General Administration of Quality Supervision according to relevant regulations.

　　Provincial quality and technical supervision departments shall determine the scope of varieties licensed by quality and technical supervision departments within their administrative regions in accordance with relevant laws, regulations, and the requirements of the General Administration of Quality Supervision.

　　Article 8 To obtain a food production license, the food safety standards must be met, and the following requirements must be satisfied:

　　(1) Have food raw material handling and food processing, packaging, storage, and other premises that correspond to the varieties and quantities of food applied for production licensing, keep the environment of these premises clean, and maintain the prescribed distance from toxic, harmful places and other pollution sources;

　　(2) Have production equipment or facilities corresponding to the varieties and quantities of food applied for production licensing, with corresponding equipment or facilities for disinfection, changing clothes, washing, lighting, ventilation, corrosion prevention, dust prevention, fly prevention, rodent prevention, insect prevention, washing, and treatment of wastewater, storage of garbage and waste;

　　(3) Have reasonable equipment layout and process flow corresponding to the varieties and quantities of food applied for production licensing to prevent cross-contamination between food to be processed and ready-to-eat food, raw materials and finished products, and avoid food contact with toxic or unclean substances;

　　(4) Have food safety professional technical personnel and management personnel corresponding to the varieties and quantities of food applied for production licensing;

　　(5) Have food safety management systems corresponding to the varieties and quantities of food applied for production licensing, including training to ensure food safety, health checks and health records of employees, inspection records of incoming goods, factory inspection records, raw material acceptance, and production processes.

　　If laws, regulations, and national industrial policies have other requirements for food production, those requirements must be met.

　　Article 9 Enterprises intending to establish food production must apply for a food production license to the quality and technical supervision department at the place of production (hereinafter referred to as the licensing authority) and submit the following materials:

　　(1) Application form for food production license;

　　(2) Copy of the applicant's identity card or qualification certificate;

　　(3) "Name Pre-approval Notice" for the proposed food production enterprise;

　　(4) Floor plan of the food production and processing premises and layout plan of each functional area of production and processing;

　　(5) List of food production equipment and facilities;

　　(6) Food production process flow chart and equipment layout diagram;

　　(7) List of food safety professional technical personnel and management personnel;

　　(8) Text of food safety management rules and regulations;

　　(9) Food safety standards implemented by the product; if enterprise standards are implemented, the enterprise standards filed with the health administrative department must be provided;

　　(10) Other supporting materials required by relevant laws and regulations.

　　The materials submitted for the food production license application must be true, legal, and valid. The applicant shall sign and confirm the food production license application form and other materials.

　　Article 10 The licensing authority shall handle the received application in accordance with Article 32 of the "Administrative Licensing Law of the People's Republic of China" and other relevant provisions.

　　If the application is accepted, a "Notice of Acceptance" shall be issued. If the application is not accepted, a "Notice of Non-Acceptance" shall be issued, stating the reasons for non-acceptance and informing the applicant of the right to apply for administrative reconsideration or initiate administrative litigation according to law.

　　Article 11 After accepting the application, the licensing authority shall organize an inspection of the application materials and production premises (hereinafter referred to as on-site inspection) in accordance with relevant regulations.

　　The on-site inspection shall be conducted by an inspection team composed of two to four inspectors appointed by the licensing authority in accordance with the relevant regulations of the General Administration of Quality Supervision, and the enterprise shall cooperate.

　　Article 12 The licensing authority shall make the following decisions within the time limit prescribed by laws and regulations based on the inspection results:

　　(1) If the production conditions meet the requirements after on-site inspection, a decision to permit production shall be made according to law, a "Decision to Permit Food Production License" shall be issued to the applicant, and the food production license certificate for establishing the food production enterprise shall be issued within ten days from the date of the decision.

　　(2) If the production conditions do not meet the requirements after on-site inspection, a decision to deny production permission shall be made according to law, a "Decision to Deny Food Production License" shall be issued to the applicant, stating the reasons.

　　Except for force majeure, if the on-site inspection cannot be conducted within the prescribed time due to reasons attributable to the applicant, it shall be treated as a failed on-site inspection.

　　Article 13 The proposed food production enterprise must obtain the food production license certificate and complete the business license industrial and commercial registration procedures according to law before organizing trial production of food according to the needs of production license inspection.

　　Article 14 Newly established food production enterprises shall apply for production license inspection for the varieties of food subject to licensing in accordance with regulations.

　　After receiving the application for production license inspection, the licensing authority shall promptly sample and seal the samples in accordance with relevant regulations, and inform the applicant enterprise to submit the samples to a qualified inspection agency within seven days after sealing.

　　Article 15: Upon receiving the samples, the inspection agency shall conduct the inspection according to the prescribed requirements and standards, and issue an accurate and timely inspection report.

　　Article 16: If the inspection conclusion is qualified, the licensing authority shall determine the scope of food production license varieties based on the inspection report and specify it on the annex page of the food production license.

　　Before the licensing authority determines the scope of food production license varieties, trial-produced food is prohibited from being sold from the factory.

　　Article 17: If the inspection conclusion is unqualified, a re-inspection may be applied for in accordance with relevant regulations.

　　If the re-inspection conclusion shows that some food varieties are unqualified, the production license scope for those food varieties shall not be determined, and they shall not be specified on the annex page of the food production license; the sale of such food from the factory is prohibited.

　　If the re-inspection conclusion shows that all food varieties are unqualified, the food production license shall be revoked in accordance with relevant regulations; the sale of all varieties of food from the factory is prohibited.

　　Article 18: Enterprises that have been established and apply for a food production license shall hold a valid business license and handle the license application procedures in accordance with the relevant conditions and requirements stipulated in this chapter.

　　The licensing authority shall accept the license application of established enterprises engaged in food production according to the relevant conditions and requirements of this chapter, and decide whether to grant the license and determine the scope of food production license varieties based on on-site inspection results and inspection reports, issuing the food production license certificate.

　　Article 19: The validity period of the food production license is three years.

　　Upon expiration, enterprises holding a food production license that need to continue production shall apply for renewal to the original licensing authority six months before the license expires; if renewal is granted, the food production license number remains unchanged.

　　If the license is not renewed upon expiration, it is deemed unlicensed; enterprises intending to continue food production shall reapply, be reissued a license, and receive a new license number, with the validity period recalculated from the date of licensing.

　　Article 20: During the validity period of the food production license, if any of the following situations occur, the enterprise shall apply for a change to the original licensing authority:

　　(1) Change of enterprise name;

　　(2) Change of domicile or production address name;

　　(3) Relocation of production site;

　　(4) Change in the surrounding environment of the production site;

　　(5) Change in equipment layout and process flow;

　　(6) Change in production equipment and facilities;

　　(7) Other circumstances requiring application for change as stipulated by laws and regulations.

　　In the cases of items (3) to (6) in the preceding paragraph, the original licensing authority shall organize verification and inspection according to the provisions of these measures; if conditions are met, the change procedures shall be handled according to law.

　　Article 21: Enterprises applying for changes to the food production license shall submit the following application materials:

　　(1) Application form for change of food production license;

　　(2) Original and duplicate copies of the food production license certificate;

　　(3) Supporting materials related to the changes in the food production license matters.

　　The materials submitted for the application to change the food production license shall be true, legal, and valid, complying with relevant laws and regulations. The applicant shall sign and confirm the application form and other materials for the change and be responsible for the legality and authenticity of their content.

　　Article 22: During the validity period of the food production license, if relevant laws, regulations, food safety standards, or technical requirements change, the original licensing authority may reorganize verification and inspection according to national regulations.

　　Article 23: In any of the following circumstances, the original licensing authority shall handle the cancellation of the food production license certificate according to law:

　　(1) The production license is lawfully withdrawn or revoked, or the production license certificate is lawfully canceled;

　　(2) The enterprise applies for cancellation or the production license expires without renewal;

　　(3) The enterprise is legally terminated;

　　(4) The production license matters cannot be implemented due to force majeure;

　　(5) Other circumstances requiring cancellation of the production license certificate as stipulated by laws and regulations.

　　Article 24: Enterprises applying for cancellation of the food production license certificate shall submit the following application materials to the original licensing authority:

　　(1) Application for cancellation of food production license;

　　(2) Original and duplicate copies of the food production license certificate;

　　(3) Supporting materials related to the cancellation of food production license matters.

　　Chapter 3 Certificates and Marks

　　Article 25: The food production license certificate is divided into original and duplicate copies, and the format of the certificate and its annex page is uniformly prescribed by the State Administration for Market Regulation.

　　Article 26: Enterprises shall properly keep the food production license certificate and display or hang it prominently at the production site.

　　If the food production license certificate is lost or damaged, the enterprise shall promptly make a declaration in media at or above the provincial level and apply for a replacement certificate in a timely manner.

　　Article 27: Enterprises shall mark the food production license number and logo on their food or its packaging; food without the food production license number and logo shall not be sold from the factory.

　　Article 28: The food production license number and logo are marks indicating that the enterprise has obtained the food production license. The rules for the food production license number and the logo format are uniformly prescribed by the State Administration for Market Regulation.

　　Article 29: Enterprises shall not rent, lend, or transfer the food production license certificate and number in any other form. Forgery or alteration of the food production license certificate, number, and logo is prohibited.

　　Chapter 4 Supervision and Inspection

　　Article 30: Enterprises shall engage in food production activities within the scope of the food production license varieties and shall not produce food beyond the licensed variety scope.

　　Article 31: Enterprises shall ensure that production conditions continuously meet the prescribed requirements and be responsible for the safety of the food they produce.

　　Article 32: Quality and technical supervision departments at all levels shall conduct regular or irregular supervision and inspection of enterprises' food production activities within their respective responsibilities according to law.

　　Article 33: Quality and technical supervision departments at all levels shall establish a file management system for food production licenses and supervision and inspection. The retention period of the files shall be implemented in accordance with relevant national regulations.

　　Article 34: Quality and Technical Supervision departments at all levels shall establish a food production licensing and supervision inspection information platform to facilitate inquiries by citizens, legal persons, and other social organizations.

　　Chapter 5 Legal Liability

　　Article 35: Violations of the provisions of Article 3, Paragraph 2 of Article 16, Paragraph 2 and Paragraph 3 of Article 17, Article 30 of these Measures, or having obtained a food production license but having it legally revoked, shall be punished in accordance with Article 84 of the Food Safety Law of the People's Republic of China.

　　Article 36: Violations of the provisions of Article 20, Article 27, Article 29 of these Measures that constitute illegal acts as defined by relevant laws and regulations shall be subject to administrative penalties in accordance with those laws and regulations.

　　Article 37: Quality and Technical Supervision departments at all levels, relevant staff, inspectors, inspection agencies, and inspection personnel who abuse their authority, neglect their duties, or engage in favoritism and fraud in the management of food production licensing shall be held legally responsible.

　　Article 38: Administrative penalties stipulated in these Measures shall be decided and implemented by local Quality and Technical Supervision departments at or above the county level within their authority. Decisions to revoke food production licenses must be reported step-by-step to the licensing authority for approval before the administrative penalty decision is made.

　　Article 39: Parties dissatisfied with administrative licenses and administrative penalties implemented according to these Measures may file for administrative reconsideration or administrative litigation in accordance with the law.

　　Chapter 6 Supplementary Provisions

　　Article 40: The term "food" as used in these Measures refers to the food defined in Article 99 of the Food Safety Law of the People's Republic of China, excluding edible agricultural products and foods claiming health functions.

　　If laws and administrative regulations have separate provisions for the food production licensing of dairy products, genetically modified foods, live pig slaughtering, alcoholic beverages, and edible salt, those provisions shall apply.

　　Article 41: The classification of food varieties subject to production licensing under these Measures shall be implemented in accordance with laws, regulations, and relevant provisions of the General Administration of Quality Supervision, Inspection and Quarantine.

　　Article 42: Catering service providers who have obtained catering service licenses do not need to obtain food production licenses under these Measures when producing and processing food at their catering service premises.

　　Article 43: Small workshops and other food producers engaged in food production activities shall comply with relevant laws and regulations.

　　Article 44: The qualifications and management of inspectors and inspection agencies stipulated in these Measures shall be implemented in accordance with relevant provisions.

　　Article 45: These Measures shall be interpreted by the General Administration of Quality Supervision, Inspection and Quarantine.

　　Article 46: These Measures shall come into effect on June 1, 2010. If there are inconsistencies between the regulations and normative documents on food production licensing promulgated by the General Administration of Quality Supervision, Inspection and Quarantine before the implementation of these Measures, these Measures shall prevail.