Measures for the Administration of Food Production Licensing (2020)

Measures for the Administration of Food Production Licensing (2020) Order of the State Administration for Market Regulation (No. 24) The Measures for the Administration of Food Production Licensing , as deliberated and adopted at the 18th executive meeting of the State Administration for Market Regulation on December 23, 2019, are hereby issued, and shall come into force on March 1, 2020. Director: Xiao Yaqing January 2, 2020 Measures for the Administration of Food Production Licensing (issued by Order No. 24 of the State Administration for Market Regulation on January 2, 2020) Chapter I General Provisions Article 1 For the purposes of regulating the licensing for the production of food and food additives, strengthening the supervision and administration of food production, and ensuring food safety, these Measures are developed in accordance with the Administrative Licensing Law of the People's Republic of China , the Food Safety Law of the People's Republic of China , the Regulation on the Implementation of the Food Safety Law of the People's Republic of China , and other laws and regulations. Article 2 Whoever intends to conduct food production activities within the territory of the People's Republic of China shall obtain a food production permit in accordance with the law. These Measures shall apply to the application for the food production permit, acceptance of applications, examination, decision-making, and the supervision and inspection thereof. Article 3 The licensing for food production shall follow the principles of legality, openness, fairness, impartiality, convenience for the people, and efficiency. Article 4 The principle of one permit for one enterprise shall apply to the licensing for food production, that is, the same food producer engaged in food production activities shall obtain a food production permit. Article 5 Market regulatory departments shall implement categorized licensing for food production on the basis of the degree of risk of food and in light of such factors as raw materials and production technique of food. Article 6 The State Administration for Market Regulation (“SAMR”) shall be responsible for the supervision and guidance of food production licensing administration nationwide. Local market regulatory departments at and above the county level shall be responsible for the supervision and administration of food production licensing within their respective administrative regions. Article 7 The market regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government may, according to food categories and food safety risk condition, determine the administrative power for food production licensing of the market regulatory departments at city and county levels. The market regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the licensing for the production of health food, formula food for special medical purposes, infant formula food, infant supplementary food, edible salt, and other food. Article 8 The SAMR shall be responsible for the development of general provisions and detailed rules on the food production licensing examination. The market regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government may, according to the needs of food production licensing examination of their respective administrative regions, develop detailed rules on food production licensing examination for food with local characteristics, which shall be implemented within their respective administrative regions and be reported to the SAMR. The detailed rules on production licensing examination for food with local characteristics shall be automatically repealed after the SAMR has developed and issued detailed rules on production licensing examination for the relevant food. Local market regulatory departments at and above the county level shall, in their food production licensing examination, comply with the general provisions and detailed rules on food production licensing examination. Article 9 Market regulatory departments at and above the county level shall accelerate informatization construction, promote the whole-process online handling of permit application, acceptance, examination, issuance of permits, and inquiry, among others, and publish production licensing matters on the websites of the administrative authorities to improve work efficiency. Chapter II Application and Acceptance Article 10 An applicant for a food production permit shall first obtain the business license and possess other required qualifications in accordance with the law. For enterprises with a legal person status, partnership enterprises, individual proprietorship enterprises, individual industrial and commercial households, and specialized farmers' cooperative organizations, among others, the subjects specified in their business licenses shall serve as the applicants. Article 11 Applications for food production permits shall be filed according to the following food categories: grain processed products, edible oil, oil and its products, condiments, meat products, dairy products, beverages, convenient food, cookies, canned food, frozen drinks, frozen food, potatoes and puffed food, candy products, tea and tea-related products, liquor, vegetable products, fruit products, roasted seeds and nuts, nut products, egg products, cocoa and baked coffee products, sugar, aquatic products, starch and starch products, pastry, bean products, bee products, health food, formula food for special medical purposes, infant formula food, food for special dietary use, and other food. The SAMR may adjust food categories according to the needs of supervision and administration. Article 12 An applicant for a food production permit shall meet the following conditions: (1) It has places for food raw material treatment and food processing, packaging, and storage, among others, suitable for the varieties and quantities of the food that it produces, keeps the environment of these places tidy and clean, and ensures that these places maintain a prescribed distance from toxic and hazardous sites and other pollution sources. (2) It has production equipment or facilities suitable for the varieties and quantities of the food that it produces, and has the corresponding equipment or facilities for disinfection, changing clothes, sanitation, day-lighting, illumination, ventilation, anti-corrosion, anti-dust, anti-fly, rat proof, mothproof, washing, waste water treatment, and storage of garbage and waste; where health food production processes include raw material extraction, purification, and other pretreatment processes, the applicant needs to have raw material pretreatment equipment or facilities suitable for the varieties and quantities of the food that it produces. (3) It has full-time or part-time professional food safety technicians and food safety management personnel and rules and regulations for ensuring food safety. (4) It has a reasonable equipment layout and technical flowchart to prevent cross-contamination between the to-be-processed food and ready-to-eat food, and between raw materials and finished products, and to prevent the food from contacting toxic substances or unclean articles. (5) Other conditions prescribed by laws and regulations. Article 13 An applicant for a food production permit shall submit the following materials to the local market regulatory department at or above the county level at the place where it is located: (1) An application form for the food production permit. (2) A layout diagram of the food production equipment and a food production technical flowchart. (3) A list of the major food production equipment and facilities. (4) The information on full-time or part-time professional food safety technicians and food safety management personnel, as well as food safety management rules. Article 14 An applicant for a production permit for health food, formula food for special medical purposes, infant formula food, or other special food shall also submit the production quality management system documents and relevant registration and recordation documents suitable for the food that it produces. Article 15 Those intending to engage in the production of food additives shall obtain a food additive production permit in accordance with the law. An applicant for a food additive production permit shall have the places, production equipment or facilities, food safety management personnel, professional technicians and management rules suitable for the varieties of food additives that it produces. Article 16 An applicant for a food additive production permit shall submit the following materials to the local market regulatory department at or above the county level at the place where it is located: (1) An application form for a food additive production permit. (2) A layout diagram of food additive production equipment and a production technical flowchart. (3) A list of major food additive production equipment and facilities. (4) The information on full-time or part-time professional food safety technicians and food safety management personnel, as well as food safety management rules. Article 17 The applicant shall truthfully submit the relevant materials and report the real situation to the market regulatory department, be responsible for the veracity of the application materials, and affix signature or seal to the application form and other materials. Article 18 An applicant for the production of several categories of food shall, according to the administrative power for food production licensing determined by the provincial market regulatory department, submit application materials to one of the acceptance departments at its discretion. The acceptance department shall inform the market regulatory departments with the corresponding approval authority in a timely manner, and organize joint examination. Article 19 The local market regulatory department at or above the county level shall handle the applicant's application for a food production permit respectively according to the following circumstances: (1) If a food production permit is not required for the subject matter of application in accordance with the law, it shall notify the applicant of non-acceptance of the application immediately. (2) If the subject matter of application does not fall under the scope of functions of the market regulatory department according to the law, it shall make a decision on non-acceptance of the application immediately, and notify the applicant to apply to the relevant administrati......