Circular of the China Food and Drug Administration on Issuing the General Rules on the Examination of Food Operation Licensing (for Trial Implementation)
Circular of the China Food and Drug Administration on Issuing the General Rules on the Examination of Food Operation Licensing (for Trial Implementation)
[Lexis China Comments]
According to the Announcement of the State Administration for Market Regulation on Issuing the General Rules on the Examination of Food Operation Licensing (Announcement of the State Administration for Market Regulation [2024] No. 12), this document has been repealed.
Circular of the China Food and Drug Administration on Issuing the General Rules on the Examination of Food Operation Licensing (for Trial Implementation)
Shi Yao Jian Shi Jian Er [2015] No.228
September 30, 2015
The food and drug administrations of provinces, autonomous regions and municipalities directly under the Central Government and the Food and Drug Administration of the Xinjiang Production and Construction Corps,
The Administrative Measures for Food Operation Licensing (hereinafter referred to as the "Measures") shall formally come into force as of October 1, 2015. In order to guarantee the smooth implementation of the Measures, the China Food and Drug Administration (hereinafter referred to as the "CFDA") has formulated the General Rules on the Examination of Food Operation Licensing (for Trial Implementation), which are hereby issued to all places for compliance and implementation. Any problems appearing in the trial implementation shall be timely reported to the CFDA.
General Rules on the Examination of Food Operation Licensing (for Trial Implementation)
Chapter I General Provisions
Article 1 In order to standardize food operation licensing, in accordance with the provisions of the Food Safety Law of the People's Republic of China and the Administrative Measures for Food Operation Licensing and other laws and regulations, the General Rules on the Examination of Food Operation Licensing (for Trial Implementation) (hereinafter referred to as the "General Rules") are formulated.
Article 2 The General Rules apply to the examination of food operation licensing applications by food and drug administrations.
Article 3 Food and drug administrations conduct classified examination of food operation licensing applications according to operators' types of operation and food operation items, with the risk level taken into consideration.
Article 4 Operators' types of operation include food sales operators, catering service operators, and canteens. Where conducting business via the Internet, establishing internally a central kitchen, or engaging in the delivery of group meals is applied for, such situation shall be marked in parentheses after the operators' type of operation.
Article 5 Food operation items are divided into the sale of prepackaged food (that containing refrigerated and frozen food and that not containing refrigerated and frozen food), the sale of unpackaged food (that containing refrigerated and frozen food and that not containing refrigerated and frozen food), the sale of special food (health food, food for special medical use, infant formula milk powder, and other infant formula food), and the sale of other food; the production and sale of hot food, the production and sale of cold food, the production and sale of uncooked food, the production and sale of pastry food, the production and sale of self-produced beverages, and the production and sale of other food. If the sale of unpackaged cooked food is applied for, the situation shall be marked in parentheses after the unpackaged food sales item.
Chapter II Basic Requirements for the Examination of Licensing
Article 6 Food operation enterprises shall be staffed by food safety management personnel, who must be trained and examined. Those who have obtained food safety related qualifications specified by the national or industrial provisions can be exempt from the examination.
Article 7 Food operation enterprises shall have the management systems that guarantee food safety. Food safety management systems shall include: workers health management system and training management system, food safety administrator system, food safety self-check and inspection and reporting system, food operation process and control system, places and facilities equipment cleaning and disinfection and maintenance system, purchase examination and inspection and examination and inspection record system, food storage management system, waste disposal system and food safety incidents emergency disposal plan.
Article 8 Food operators shall have food operation and storage places which are appropriate for the varieties and quantities of food they operate. Food operation and food storage places shall not be located in areas vulnerable to pollution, and shall be kept not less than 25 m away from the cesspits, sewage pools, exposed dumps (garbage stations) and dry toilets and other sources of pollution.
Article 9 Food operators shall, according to the operation items, set corresponding operation equipment or facilities, and the corresponding disinfection, dressing, sanitation, natural lighting, illumination, ventilation, anti-corrosion, dust prevention, fly prevention, rat prevention, insect prevention and other equipment or facilities.
Article 10 The equipment or facilities, tools, containers and packaging materials in direct contact with food shall have product qualification certificates, shall be made of safe, non-toxic, not smelly, anti-absorption, and corrosion-resistant materials that can withstand repeated washing and disinfecting and are easy to clean and maintain.
Article 11 Food operators operating in entity stores and meanwhile engaged in the operation of food via the Internet shall, in addition to satisfying the above conditions, provide licensing authorities with facilities and equipment with the functions of logging onto on site applicants' websites, web pages or online stores for review by licensing authorities.
Article 12 Online food operators without entity stores shall have the food operation places which are appropriate for the varieties and quantities of food they operate, with the storage places regarded as food operation places, and shall provide licensing authorities with facilities and equipment with the functions of logging onto on site applicants' websites, web pages or online stores for review by licensing authorities.
Storage places, people and food safety management systems shall conform to the general requirements of the present Chapter.
Online food operators without entity stores shall not apply for all food production and sales items and the sale of unpackaged cooked food.
Chapter III Examination Requirements for Food Sales Licensing
Article 13 In case of an application for the sale of prepackaged food (that containing refrigerated and frozen food and that not containing refrigerated and frozen food), the licensing examination shall be in conformity with general requirements of Chapter II and Section 1 of the present Chapter.
Article 14 In case of applications for the sale of unpackaged food (that containing refrigerated and frozen food and that not containing refrigerated and frozen food) and the sale of special food (health food, food for special medical use, infant formula milk powder, and other infant formula food), the licensing examination shall satisfy corresponding provisions of Sections 2 to 3 of the present Chapter, in addition to the general requirements of Section 1 of the present Chapter.
Section 1 General Requirements
Article 15 The food sales places and food storage places shall have a clean and tidy environment and good ventilation and exhaust devices, and avoid direct sunlight.
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According to the Announcement of the State Administration for Market Regulation on Issuing the General Rules on the Examination of Food Operation Licensing (Announcement of the State Administration for Market Regulation [2024] No. 12), this document has been repealed.
Circular of the China Food and Drug Administration on Issuing the General Rules on the Examination of Food Operation Licensing (for Trial Implementation)
Shi Yao Jian Shi Jian Er [2015] No.228
September 30, 2015
The food and drug administrations of provinces, autonomous regions and municipalities directly under the Central Government and the Food and Drug Administration of the Xinjiang Production and Construction Corps,
The Administrative Measures for Food Operation Licensing (hereinafter referred to as the "Measures") shall formally come into force as of October 1, 2015. In order to guarantee the smooth implementation of the Measures, the China Food and Drug Administration (hereinafter referred to as the "CFDA") has formulated the General Rules on the Examination of Food Operation Licensing (for Trial Implementation), which are hereby issued to all places for compliance and implementation. Any problems appearing in the trial implementation shall be timely reported to the CFDA.
General Rules on the Examination of Food Operation Licensing (for Trial Implementation)
Chapter I General Provisions
Article 1 In order to standardize food operation licensing, in accordance with the provisions of the Food Safety Law of the People's Republic of China and the Administrative Measures for Food Operation Licensing and other laws and regulations, the General Rules on the Examination of Food Operation Licensing (for Trial Implementation) (hereinafter referred to as the "General Rules") are formulated.
Article 2 The General Rules apply to the examination of food operation licensing applications by food and drug administrations.
Article 3 Food and drug administrations conduct classified examination of food operation licensing applications according to operators' types of operation and food operation items, with the risk level taken into consideration.
Article 4 Operators' types of operation include food sales operators, catering service operators, and canteens. Where conducting business via the Internet, establishing internally a central kitchen, or engaging in the delivery of group meals is applied for, such situation shall be marked in parentheses after the operators' type of operation.
Article 5 Food operation items are divided into the sale of prepackaged food (that containing refrigerated and frozen food and that not containing refrigerated and frozen food), the sale of unpackaged food (that containing refrigerated and frozen food and that not containing refrigerated and frozen food), the sale of special food (health food, food for special medical use, infant formula milk powder, and other infant formula food), and the sale of other food; the production and sale of hot food, the production and sale of cold food, the production and sale of uncooked food, the production and sale of pastry food, the production and sale of self-produced beverages, and the production and sale of other food. If the sale of unpackaged cooked food is applied for, the situation shall be marked in parentheses after the unpackaged food sales item.
Chapter II Basic Requirements for the Examination of Licensing
Article 6 Food operation enterprises shall be staffed by food safety management personnel, who must be trained and examined. Those who have obtained food safety related qualifications specified by the national or industrial provisions can be exempt from the examination.
Article 7 Food operation enterprises shall have the management systems that guarantee food safety. Food safety management systems shall include: workers health management system and training management system, food safety administrator system, food safety self-check and inspection and reporting system, food operation process and control system, places and facilities equipment cleaning and disinfection and maintenance system, purchase examination and inspection and examination and inspection record system, food storage management system, waste disposal system and food safety incidents emergency disposal plan.
Article 8 Food operators shall have food operation and storage places which are appropriate for the varieties and quantities of food they operate. Food operation and food storage places shall not be located in areas vulnerable to pollution, and shall be kept not less than 25 m away from the cesspits, sewage pools, exposed dumps (garbage stations) and dry toilets and other sources of pollution.
Article 9 Food operators shall, according to the operation items, set corresponding operation equipment or facilities, and the corresponding disinfection, dressing, sanitation, natural lighting, illumination, ventilation, anti-corrosion, dust prevention, fly prevention, rat prevention, insect prevention and other equipment or facilities.
Article 10 The equipment or facilities, tools, containers and packaging materials in direct contact with food shall have product qualification certificates, shall be made of safe, non-toxic, not smelly, anti-absorption, and corrosion-resistant materials that can withstand repeated washing and disinfecting and are easy to clean and maintain.
Article 11 Food operators operating in entity stores and meanwhile engaged in the operation of food via the Internet shall, in addition to satisfying the above conditions, provide licensing authorities with facilities and equipment with the functions of logging onto on site applicants' websites, web pages or online stores for review by licensing authorities.
Article 12 Online food operators without entity stores shall have the food operation places which are appropriate for the varieties and quantities of food they operate, with the storage places regarded as food operation places, and shall provide licensing authorities with facilities and equipment with the functions of logging onto on site applicants' websites, web pages or online stores for review by licensing authorities.
Storage places, people and food safety management systems shall conform to the general requirements of the present Chapter.
Online food operators without entity stores shall not apply for all food production and sales items and the sale of unpackaged cooked food.
Chapter III Examination Requirements for Food Sales Licensing
Article 13 In case of an application for the sale of prepackaged food (that containing refrigerated and frozen food and that not containing refrigerated and frozen food), the licensing examination shall be in conformity with general requirements of Chapter II and Section 1 of the present Chapter.
Article 14 In case of applications for the sale of unpackaged food (that containing refrigerated and frozen food and that not containing refrigerated and frozen food) and the sale of special food (health food, food for special medical use, infant formula milk powder, and other infant formula food), the licensing examination shall satisfy corresponding provisions of Sections 2 to 3 of the present Chapter, in addition to the general requirements of Section 1 of the present Chapter.
Section 1 General Requirements
Article 15 The food sales places and food storage places shall have a clean and tidy environment and good ventilation and exhaust devices, and avoid direct sunlight.
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