Implementing Regulations of the Food Safety Law of the People's Republic of China (Revised in 2019)
Implementing Regulations of the Food Safety Law of the People's Republic of China (Revised in 2019)
Implementing Regulations of the Food Safety Law of the People's Republic of China (Revised in 2019)
Order of the State Council of the People's Republic of China No. 721
October 11, 2019
The Implementing Regulations of the Food Safety Law of the People's Republic of China, which were revised and adopted at the 42nd executive meeting of the State Council on March 26, 2019, are hereby issued and shall come into effect as of December 1, 2019.
Premier Li Keqiang
Implementing Regulations of the Food Safety Law of the People's Republic of China (Revised in 2019)
(issued on July 20, 2009 as the Order of the State Council of the People's Republic of China No. 557; revised under the Decision of the State Council on Amending Certain Administrative Regulations issued on February 6, 2016; revised and adopted at the 42nd executive meeting of the State Council on March 26, 2019)
Chapter I General Provisions
Article 1 These Regulations are formulated in accordance with the Food Safety Law of the People's Republic of China (hereinafter referred to as the "Food Safety Law").
Article 2 Food producers and business operators shall, in accordance with laws, regulations and food safety standards, engage in production and business operation activities, establish a sound food safety management system, and take effective measures to prevent and control food safety risks, thus ensuring food safety.
Article 3 The Food Safety Committee of the State Council shall be responsible for analyzing the food safety situation, researching and deploying, coordinating and guiding food safety work, putting forward major policies on and measures for food safety supervision and management, and propelling the implementation of food safety supervision and management responsibilities. The food safety committee of each local people's government at or above the county level shall carry out relevant work in light of its duties prescribed by the people's government at the same level.
Article 4 Each people's government at or above the county level shall establish a unified and authoritative food safety supervision and management system and strengthen the capacity building in terms of food safety supervision and management.
The food safety supervision and management department and other relevant departments of each people's government at or above the county level shall, in accordance with the law, perform their duties, strengthen coordination and cooperation and effectively carry out food safety supervision and management work.
Each township people's government and sub-district office shall support and assist the food safety supervision and management department of the corresponding people's government at the county level and local office thereof to carry out food safety supervision and management work in accordance with the law.
Article 5 The State shall incorporate food safety knowledge into the content of national quality education, and popularize food safety-related scientific common sense and legal knowledge to raise the food safety awareness of the whole of society.
Chapter II Food Safety Risk Monitoring and Assessment
Article 6 The health administrative department of each people's government at or above the county level shall, in collaboration with the food safety supervision and management department, etc., at the same level, establish a food safety risk monitoring and consultation mechanism, summarize and analyze risk monitoring data, study and identify food safety risks, and form a food safety risk monitoring and analysis report, which shall be submitted to the people's government at the same level and further to the health administrative department of the people's government at the next higher level concurrently. The specific measures for food safety risk monitoring and consultation shall be formulated by the health administrative department of the State Council in collaboration with the food safety supervision and management department, etc. of the State Council.
Article 7 In the case of any potential food safety hazard as indicated by the food safety risk monitoring result, the relevant food producer or business operator shall be notified thereof in a timely manner where necessary as confirmed upon further investigation by the competent food safety supervision and management department, etc.
The food producer or business operator shall immediately conduct a self-check upon receipt of the notice, and if the food fails to meet the food safety standards as identified or there is evidence proving that it may endanger human health, stop its production and business operation, implement a food recall and report the relevant situation in accordance with Article 63 of the Food Safety Law.
Article 8 The health administrative department, the food safety supervision and management department, etc., of the State Council shall, where necessary, conduct a safety assessment of any pesticide, fertilizer, veterinary drug, feed and feed additive, etc. as identified, and put forward safety assessment proposals to the agriculture administrative department of the State Council, which shall organize the assessment in a timely manner and notify relevant departments of the State Council of the assessment result.
Article 9 The food safety supervision and management department and other relevant departments of the State Council shall establish a food safety risk information exchange mechanism and specify food safety risk information exchange contents, procedures and requirements.
Chapter III Food Safety Standards
Article 10 The health administrative department of the State Council shall, in collaboration with the food safety supervision and management department and the agriculture administrative department, etc. of the State Council, develop a national standard plan on food safety and an annual plan for the implementation thereof, and publish the drafts of such national standard plan on food safety and the annual plan for the implementation thereof on its website and seek public comments thereon.
Article 11 The health administrative department of the people's government of each province, autonomous region or municipality directly under the Central Government shall, in accordance with Article 29 of the Food Safety Law, develop local standards for food safety and seek public comments thereon, and report such local standards for food safety to the health administrative department of the State Council for filing within 30 working days after the issuance date thereof, which shall make corrections without delay if the local standards for food safety filed are identified as being in violation of laws, regulations or national standards for food safety.
Where the local standards for food safety are repealed in accordance with the law, the health administrative department of the people's government of the relevant province, autonomous region or municipality directly under the Central Government shall promptly announce the repeal thereof on its website.
Article 12 No special food such as healthcare food, formula food for special medical use, and formula food for infants and young children may be identified as local specialty food or be subject to any local standard for food safety.
Article 13 After the issuance of food safety standards, food producers and business operators may carry out implementation thereof prior to the implementing date prescribed therein and disclose the relevant situation concerning such advance implementation.
Article 14 No food production enterprise may develop any enterprise standard that is below the requirements of national or local standards for food safety. Where a food production enterprise develops any food safety indicators stricter than national or local standards for food safety, it shall be reported to the health administrative department of the people's government of the relevant province, autonomous region or municipality directly under the Central Government for filing.
Enterprise standards developed by food production enterprises shall be disclosed for public access free of charge.
Chapter IV Food Production and Business Operation
Article 15 A food production and business operation license shall be valid for a period of five years.
In the case of any change to the production or business operation conditions of a food producer or business operator, thus causing the failure thereof to comply with the requirements on food production and business operation, the relevant food producer or business operator shall immediately take rectification measures; and where necessary, go through the licensing procedures anew in accordance with the law.
Article 16 The health administrative department of the State Council shall promptly issue the catalog of new food ingredients, new varieties of food additives and new varieties of food-related products as well as the applicable national standards for food safety.
The health administrative department of the State Council shall, in collaboration with the food safety supervision and management department of the State Council, update the catalog of substances traditionally considered as both food and traditional Chinese medicine herbs in a timely manner.
Article 17 The food safety supervision and management department of the State Council shall, in collaboration with the agriculture administrative department and other relevant departments of the State Council, clarify the basic requirements on whole-process traceability for food safety, and guide food producers and business operators to establish and refine a food safety traceability system by means of information.
Food safety supervision and management departments, etc., shall take the establishment of a traceability system for foods for specific groups such as formula foods for infants and young children and those with high food safety risks or large sales volumes as the focus of supervision and inspection.
Article 18 Food producers and business operators shall establish a food safety traceability system, and faithfully record and keep information on incoming inspection, exit-factory inspection, food sales, etc.
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Order of the State Council of the People's Republic of China No. 721
October 11, 2019
The Implementing Regulations of the Food Safety Law of the People's Republic of China, which were revised and adopted at the 42nd executive meeting of the State Council on March 26, 2019, are hereby issued and shall come into effect as of December 1, 2019.
Premier Li Keqiang
Implementing Regulations of the Food Safety Law of the People's Republic of China (Revised in 2019)
(issued on July 20, 2009 as the Order of the State Council of the People's Republic of China No. 557; revised under the Decision of the State Council on Amending Certain Administrative Regulations issued on February 6, 2016; revised and adopted at the 42nd executive meeting of the State Council on March 26, 2019)
Chapter I General Provisions
Article 1 These Regulations are formulated in accordance with the Food Safety Law of the People's Republic of China (hereinafter referred to as the "Food Safety Law").
Article 2 Food producers and business operators shall, in accordance with laws, regulations and food safety standards, engage in production and business operation activities, establish a sound food safety management system, and take effective measures to prevent and control food safety risks, thus ensuring food safety.
Article 3 The Food Safety Committee of the State Council shall be responsible for analyzing the food safety situation, researching and deploying, coordinating and guiding food safety work, putting forward major policies on and measures for food safety supervision and management, and propelling the implementation of food safety supervision and management responsibilities. The food safety committee of each local people's government at or above the county level shall carry out relevant work in light of its duties prescribed by the people's government at the same level.
Article 4 Each people's government at or above the county level shall establish a unified and authoritative food safety supervision and management system and strengthen the capacity building in terms of food safety supervision and management.
The food safety supervision and management department and other relevant departments of each people's government at or above the county level shall, in accordance with the law, perform their duties, strengthen coordination and cooperation and effectively carry out food safety supervision and management work.
Each township people's government and sub-district office shall support and assist the food safety supervision and management department of the corresponding people's government at the county level and local office thereof to carry out food safety supervision and management work in accordance with the law.
Article 5 The State shall incorporate food safety knowledge into the content of national quality education, and popularize food safety-related scientific common sense and legal knowledge to raise the food safety awareness of the whole of society.
Chapter II Food Safety Risk Monitoring and Assessment
Article 6 The health administrative department of each people's government at or above the county level shall, in collaboration with the food safety supervision and management department, etc., at the same level, establish a food safety risk monitoring and consultation mechanism, summarize and analyze risk monitoring data, study and identify food safety risks, and form a food safety risk monitoring and analysis report, which shall be submitted to the people's government at the same level and further to the health administrative department of the people's government at the next higher level concurrently. The specific measures for food safety risk monitoring and consultation shall be formulated by the health administrative department of the State Council in collaboration with the food safety supervision and management department, etc. of the State Council.
Article 7 In the case of any potential food safety hazard as indicated by the food safety risk monitoring result, the relevant food producer or business operator shall be notified thereof in a timely manner where necessary as confirmed upon further investigation by the competent food safety supervision and management department, etc.
The food producer or business operator shall immediately conduct a self-check upon receipt of the notice, and if the food fails to meet the food safety standards as identified or there is evidence proving that it may endanger human health, stop its production and business operation, implement a food recall and report the relevant situation in accordance with Article 63 of the Food Safety Law.
Article 8 The health administrative department, the food safety supervision and management department, etc., of the State Council shall, where necessary, conduct a safety assessment of any pesticide, fertilizer, veterinary drug, feed and feed additive, etc. as identified, and put forward safety assessment proposals to the agriculture administrative department of the State Council, which shall organize the assessment in a timely manner and notify relevant departments of the State Council of the assessment result.
Article 9 The food safety supervision and management department and other relevant departments of the State Council shall establish a food safety risk information exchange mechanism and specify food safety risk information exchange contents, procedures and requirements.
Chapter III Food Safety Standards
Article 10 The health administrative department of the State Council shall, in collaboration with the food safety supervision and management department and the agriculture administrative department, etc. of the State Council, develop a national standard plan on food safety and an annual plan for the implementation thereof, and publish the drafts of such national standard plan on food safety and the annual plan for the implementation thereof on its website and seek public comments thereon.
Article 11 The health administrative department of the people's government of each province, autonomous region or municipality directly under the Central Government shall, in accordance with Article 29 of the Food Safety Law, develop local standards for food safety and seek public comments thereon, and report such local standards for food safety to the health administrative department of the State Council for filing within 30 working days after the issuance date thereof, which shall make corrections without delay if the local standards for food safety filed are identified as being in violation of laws, regulations or national standards for food safety.
Where the local standards for food safety are repealed in accordance with the law, the health administrative department of the people's government of the relevant province, autonomous region or municipality directly under the Central Government shall promptly announce the repeal thereof on its website.
Article 12 No special food such as healthcare food, formula food for special medical use, and formula food for infants and young children may be identified as local specialty food or be subject to any local standard for food safety.
Article 13 After the issuance of food safety standards, food producers and business operators may carry out implementation thereof prior to the implementing date prescribed therein and disclose the relevant situation concerning such advance implementation.
Article 14 No food production enterprise may develop any enterprise standard that is below the requirements of national or local standards for food safety. Where a food production enterprise develops any food safety indicators stricter than national or local standards for food safety, it shall be reported to the health administrative department of the people's government of the relevant province, autonomous region or municipality directly under the Central Government for filing.
Enterprise standards developed by food production enterprises shall be disclosed for public access free of charge.
Chapter IV Food Production and Business Operation
Article 15 A food production and business operation license shall be valid for a period of five years.
In the case of any change to the production or business operation conditions of a food producer or business operator, thus causing the failure thereof to comply with the requirements on food production and business operation, the relevant food producer or business operator shall immediately take rectification measures; and where necessary, go through the licensing procedures anew in accordance with the law.
Article 16 The health administrative department of the State Council shall promptly issue the catalog of new food ingredients, new varieties of food additives and new varieties of food-related products as well as the applicable national standards for food safety.
The health administrative department of the State Council shall, in collaboration with the food safety supervision and management department of the State Council, update the catalog of substances traditionally considered as both food and traditional Chinese medicine herbs in a timely manner.
Article 17 The food safety supervision and management department of the State Council shall, in collaboration with the agriculture administrative department and other relevant departments of the State Council, clarify the basic requirements on whole-process traceability for food safety, and guide food producers and business operators to establish and refine a food safety traceability system by means of information.
Food safety supervision and management departments, etc., shall take the establishment of a traceability system for foods for specific groups such as formula foods for infants and young children and those with high food safety risks or large sales volumes as the focus of supervision and inspection.
Article 18 Food producers and business operators shall establish a food safety traceability system, and faithfully record and keep information on incoming inspection, exit-factory inspection, food sales, etc.
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