Food Safety Law Implementing Regulations of the PRC — Full English Translation (2019 Revision)

Promulgated by the State Council on July 20, 2009 (State Council Order No. 557)

Revised on February 6, 2016 (State Council Order No. 666); Revised on March 26, 2019 (State Council Order No. 721)

Effective: December 1, 2019

Table of Contents

Chapter I — General Provisions

Article 1 — These Regulations are formulated in accordance with the Food Safety Law of the People’s Republic of China.

Article 2 — Food producers and traders shall engage in production and trading activities in accordance with laws, regulations, and food safety standards, establish and improve food safety management systems, adopt effective measures to prevent and control food safety risks, and ensure food safety.

Article 3 — The State Council food safety administrative department and other relevant departments shall, in accordance with their respective functions and duties, strengthen the publicity and education of food safety laws, regulations, and food safety standards. Trade associations shall strengthen industry self-discipline and guide and urge food producers and traders to engage in production and trading activities in accordance with law.

Chapter II — Food Safety Risk Monitoring

Article 4 — The State Council health administrative department shall, jointly with the State Council food safety administrative department and other relevant departments, formulate and implement the national food safety risk monitoring plan. The people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government shall, in accordance with the national food safety risk monitoring plan and the specific conditions of their respective regions, formulate and implement food safety risk monitoring plans for their respective administrative regions.

Article 5 — The food safety risk monitoring work shall be organized and carried out by the health administrative departments of the people’s governments at or above the county level jointly with the food safety administrative departments and other relevant departments at the same level. The entities undertaking food safety risk monitoring shall, in accordance with the monitoring plans and monitoring plans, carry out monitoring work to ensure the truthfulness and accuracy of the monitoring data, and shall submit the monitoring data and analysis results in accordance with the requirements of the monitoring plans and monitoring plans.

Article 6 — Where food safety risk monitoring results indicate that food safety hazards may exist, the health administrative department of the people’s government at or above the county level shall promptly notify the food safety administrative department and other relevant departments at the same level of the relevant information, and report to the people’s government at the same level and the health administrative department of the people’s government at a higher level. After receiving the notification, the food safety administrative department and other relevant departments shall organize further investigation and carry out risk assessment of hidden food safety hazards in accordance with law.

Chapter III — Food Safety Standards

Article 7 — The State Council health administrative department shall, jointly with the State Council food safety administrative department and other relevant departments, formulate national food safety standards. The formulation of national food safety standards shall be based on the results of food safety risk assessments, take full account of the results of food safety risk monitoring, and make reference to relevant international standards and the results of international food safety risk assessments.

Article 8 — Where local standards for food safety are required for local specialty foods for which no national food safety standards exist, the health administrative department of the people’s government of the province, autonomous region, or municipality directly under the Central Government shall, in accordance with the provisions of the Food Safety Law, formulate local food safety standards and submit them to the State Council health administrative department for filing.

Article 9 — Food producers shall not formulate enterprise standards lower than the national food safety standards or local food safety standards. Food producers shall be responsible for the safety of the enterprise standards they formulate and shall submit the enterprise standards to the health administrative department of the people’s government of the province, autonomous region, or municipality directly under the Central Government for filing in accordance with the relevant provisions.

Chapter IV — Food Production and Trade

Article 10 — Food producers and traders shall not engage in food production and trading activities before obtaining a food production and trading license in accordance with law. Where food producers have already obtained a food production license, they are not required to obtain a food trading license when selling food they produce at their production premises or online.

Article 11 — Food producers and traders shall establish a food safety self-inspection system, conduct regular inspections and evaluations of their food safety conditions, and immediately take measures to make rectifications if they discover that they do not comply with food safety requirements.

Article 12 — Food producers and traders shall establish a food safety traceability system, truthfully record and preserve information on the purchase inspection, factory inspection, food sales, and other relevant information in accordance with the provisions, to ensure that the food is traceable. The retention period for records and vouchers shall comply with the provisions of Article 50 of the Food Safety Law.

Article 13 — Food producers and traders shall establish a food recall system. Where food producers discover that their food does not comply with food safety standards or there is evidence that it may endanger human health, they shall immediately cease production, recall the food already on the market, notify the relevant producers, traders, and consumers, and record the recall and notification. Where food traders discover that the food they trade does not comply with food safety standards or there is evidence that it may endanger human health, they shall immediately cease trading, notify the relevant producers, traders, and consumers, and record the cessation of trading and notification.

Article 14 — Food producers and traders shall not engage in false advertising or disseminate false information about food safety. Food producers and traders shall be responsible for the authenticity and legality of the content of their food advertising and the food safety information they disseminate.

Article 15 — School, childcare institution, elderly care institution, construction site, and other centralized dining entity’s canteens shall strictly comply with laws, regulations, and food safety standards. Dining service providers that provide dining services for centralized dining entities shall strictly comply with laws, regulations, and food safety standards to ensure food safety.

Article 16 — Operators of food trade at centralized trading markets, lessors of counters, and organizers of trade fairs shall examine the permits of food traders entering the market in accordance with law, clarify their food safety management responsibilities, conduct regular inspections of the food safety conditions of food traders entering the market, and promptly cease any food safety violations discovered and immediately report such violations to the market regulation department of the local people’s government at the county level.

Article 17 — Where food producers and traders entrust a third party to produce food, they shall entrust enterprises that have obtained a food production license to carry out such production, and shall supervise the entrusted parties. The entrusted parties shall produce in accordance with laws, regulations, food safety standards, and the contract, and shall be responsible for food safety.

Article 18 — Health food, formula foods for special medical purposes, and infant formula foods shall not be repackaged in separate packages. Food produced in small workshops shall not be sold online. Specific measures for the administration of online food trading shall be formulated by the State Council food safety administrative department.

Chapter V — Food Inspection

Article 19 — Food inspection agencies shall carry out inspection work in accordance with the relevant national certification and accreditation regulations and shall not issue false inspection reports. Food inspection agencies and their inspectors shall be responsible for the inspection data and conclusions they produce. Food inspection agencies shall not fabricate inspection data or conclusions.

Article 20 — Food producers and traders may conduct their own inspections of the food they produce and trade, or entrust food inspection agencies that comply with the provisions of the Food Safety Law to carry out such inspections. Food producers and traders shall ensure that the food they produce and trade passes inspection before leaving the factory or being sold.

Article 21 — Where food producers and traders disagree with the conclusions of the inspection conducted in accordance with the provisions of the Food Safety Law, they may apply to the food safety administrative department that organized the inspection for re-inspection within seven working days from the date of receipt of the inspection conclusions, and the food safety administrative department that organized the inspection shall accept or reject the application within five working days from the date of receipt of the re-inspection application.

Chapter VI — Food Import and Export

Article 22 — Imported food shall comply with China’s national food safety standards. Where imported food does not have a Chinese national food safety standard, the overseas exporter or overseas producer or its entrusted importer shall submit the relevant national (regional) standards or international standards implemented by the food to the State Council health administrative department. The State Council health administrative department shall review the relevant standards and consider whether a temporary national food safety standard is required. Where imported food exploits new food raw materials or new varieties of food additives, the relevant provisions on the safety assessment of new food raw materials or new varieties of food additives shall apply.

Article 23 — Imported food shall have a Chinese label or a Chinese label attached in accordance with law. The Chinese label shall comply with the provisions of the Food Safety Law and other relevant Chinese laws and administrative regulations, and shall be consistent with the content of the relevant certificates and conformity assessment materials of the exported country (region). The Chinese label of imported health food and formula foods for special medical purposes shall also comply with the provisions of the relevant Chinese laws and administrative regulations.

Article 24 — Overseas exporters or overseas producers shall ensure that the food, food additives, and food-related products exported to China comply with the requirements of the Food Safety Law and other relevant Chinese laws and administrative regulations and with China’s national food safety standards, and shall be responsible for the content of the labels and instructions. Importers shall establish a system for the examination and verification of overseas exporters and overseas producers, focusing on their compliance with the Food Safety Law and other relevant Chinese laws and administrative regulations as well as China’s national food safety standards. Importers shall establish a food import and sales record system and shall truthfully record the information.

Article 25 — The State shall implement a registration system for overseas producers of imported food. Overseas food producers exporting food to China shall register with the State entry-exit inspection and quarantine authority. The State shall implement a filing system for overseas exporters and overseas producers of imported food. Overseas exporters and overseas producers of imported food shall file with the State entry-exit inspection and quarantine authority.

Article 26 — Export food producers shall ensure that their export food complies with the standards of the importing country (region) and the requirements of the contract. The entry-exit inspection and quarantine authority shall supervise and conduct random inspections of export food. The customs shall release export food based on the release certificate issued by the entry-exit inspection and quarantine authority. Where export food producers and raw material planting or breeding farms file with the entry-exit inspection and quarantine authority, the entry-exit inspection and quarantine authority shall announce the list of those that have filed in a timely manner.

Chapter VII — Handling of Food Safety Incidents

Article 27 — The State Council shall organize the formulation of a national emergency response plan for food safety incidents. Local people’s governments at or above the county level shall, in accordance with the provisions of the relevant laws and regulations and the food safety emergency response plans of the people’s governments at a higher level and in light of the actual conditions of their respective administrative regions, formulate food safety emergency response plans for their respective administrative regions and submit them to the people’s governments at the next higher level for filing.

Article 28 — Food producers and traders shall formulate plans for handling food safety incidents, and regularly inspect the implementation of the food safety preventive measures in their own enterprises to eliminate food safety hazards in a timely manner.

Article 29 — Where a food safety incident occurs, the food safety administrative department of the people’s government at or above the county level shall immediately investigate and deal with the incident jointly with the relevant departments such as health administration and agriculture and rural affairs, and carry out the following work: (1) carrying out emergency rescue to avoid or reduce the harm to personnel; (2) sealing up the food and raw materials, tools, equipment, and premises that have led or may lead to the food safety incident; (3) conducting inspection and testing of food that has caused the food safety incident; and (4) conducting an epidemiological investigation of the food safety incident.

Chapter VIII — Supervision and Administration

Article 30 — The food safety administrative departments of the local people’s governments at or above the county level shall formulate annual plans for food safety supervision and administration, and shall, based on the results of food safety risk monitoring, risk assessment, food safety status, and other factors, determine the focus, methods, and frequency of supervision and administration, and implement risk-based management.

Article 31 — The food safety administrative departments of the people’s governments at or above the county level shall establish food safety credit files for food producers and traders, recording the issuance of permits, the results of daily supervision and inspection, the investigation and punishment of illegal acts, and other information, and shall disclose such information to the public in accordance with law. For food producers and traders with bad credit records, the frequency of supervision and inspection shall be increased.

Article 32 — The food safety administrative departments of the local people’s governments at or above the county level shall establish a food safety information reporting system, publish the contact information of their respective departments, and accept and handle reports in accordance with their functions and duties. Rewards shall be given to verified reports and whistleblowers shall be protected.

Article 33 — The State shall establish a unified food safety information platform and implement a unified system for the release of food safety information. The food safety administrative department of the State Council shall uniformly publish national food safety information in accordance with the provisions.

Chapter IX — Legal Liability

Article 34 — Where food producers and traders violate the provisions of Article 10 of these Regulations by engaging in food production and trading activities without obtaining a food production and trading license in accordance with law, penalties shall be imposed in accordance with the provisions of the Food Safety Law.

Article 35 — Where food producers and traders violate the provisions of these Regulations by producing or trading food that does not comply with food safety standards, failing to establish a food safety self-inspection system, failing to establish a food safety traceability system, failing to establish a food recall system, or committing other acts in violation of the provisions of these Regulations, the relevant competent departments shall impose penalties in accordance with their respective functions and duties and the provisions of the Food Safety Law.

Article 36 — Where food producers and traders produce or trade food that does not comply with food safety standards, and cause personal injury, property damage, or other damage, they shall bear civil liability in accordance with law. Where the case constitutes a crime, criminal liability shall be investigated in accordance with law.

Article 37 — Where the relevant government departments and their staff fail to perform their duties of food safety supervision and administration, or abuse their power, neglect their duties, or engage in malpractices for personal gain, the directly responsible persons in charge and other directly responsible persons shall be given sanctions in accordance with law. Where the case constitutes a crime, criminal liability shall be investigated in accordance with law.

Chapter X — Supplementary Provisions

Article 38 — Food safety incidents shall be classified into four levels: particularly serious, serious, relatively serious, and general food safety incidents. The grading standards for food safety incidents shall be formulated by the State Council food safety administrative department jointly with the relevant departments of the State Council.

Article 39 — The administration of the production and trading of food and food additives on national highways and waterways shall be governed by the relevant provisions of the Food Safety Law and these Regulations. The specific measures shall be separately formulated by the State Council food safety administrative department jointly with the relevant departments of the State Council.

Article 40 — These Regulations shall be effective as of the date of promulgation (December 1, 2019).