Food Safety Law of the PRC — Full English Translation (2021 Amendment)

Adopted at the 7th Meeting of the Standing Committee of the Eleventh National People’s Congress on February 28, 2009

Revised in accordance with the Decision on Revising the Food Safety Law of the PRC adopted at the 14th Meeting of the Standing Committee of the Twelfth National People’s Congress on April 24, 2015

Amended in accordance with the Decision on Amending the Food Safety Law of the PRC adopted at the 7th Meeting of the Standing Committee of the Thirteenth National People’s Congress on December 29, 2018

Amended in accordance with the Decision on Amending the Food Safety Law of the PRC adopted at the 28th Meeting of the Standing Committee of the Thirteenth National People’s Congress on April 29, 2021

Effective: April 29, 2021

Table of Contents

Chapter I — General Provisions

Article 1 — This Law is enacted for the purpose of ensuring food safety and protecting the health and safety of the public.

Article 2 — The following activities within the territory of the PRC shall comply with this Law: (1) food production and processing, and food distribution and catering services; (2) production and trading of food additives; (3) production and trading of packaging materials, containers, detergents, disinfectants, and tools and equipment used for food; (4) use of food additives and food-related products by food producers and traders; (5) storage and transport of food; (6) safety management of food, food additives, and food-related products. The quality and safety management of edible agricultural products shall be governed by the Law of the PRC on the Quality and Safety of Agricultural Products.

Article 3 — Food safety work shall follow the principles of prevention first, risk management, whole-process control, and social co-governance, and shall establish a scientific and rigorous supervision and management system.

Article 4 — Food producers and traders shall assume primary responsibility for the safety of the food they produce or trade. Food producers and traders shall engage in production and trade activities in accordance with laws, regulations, and food safety standards, ensure food safety, be honest and self-disciplined, be responsible to society and the public, accept social supervision, and assume social responsibility.

Article 5 — The State Council shall establish a food safety committee, the functions of which shall be prescribed by the State Council. The food safety supervision and administration department under the State Council shall be responsible for the comprehensive coordination of food safety supervision and administration nationwide. Other relevant departments under the State Council shall be responsible for food safety supervision and administration within their respective functions.

Article 6 — Local people’s governments at or above the county level shall be responsible for the food safety supervision and administration work within their respective administrative regions, unify leadership, organization, and coordination of food safety supervision and administration and response to food safety emergencies, and establish and improve the whole-process food safety supervision and administration working mechanism and information sharing mechanism.

Article 7 — Food industry associations shall strengthen industry self-discipline and guide food producers and traders to produce and trade in accordance with the law, promote integrity in the industry, and publicize and disseminate food safety knowledge.

Article 8 — The State shall encourage and support scientific research and technological development related to food safety, and encourage food producers and traders to adopt advanced technologies and advanced management standards to improve food safety levels. All organizations and individuals shall have the right to report food safety violations and obtain food safety information from relevant authorities in accordance with the law.

Article 9 — The State shall establish and improve a food safety information disclosure system. The food safety supervision and administration authorities and other relevant departments shall publish food safety information in accordance with the law.

Chapter II — Food Safety Risk Monitoring and Assessment

Article 10 — The State shall establish a food safety risk monitoring system to monitor foodborne diseases, food contamination, and harmful factors in food. The health administration department under the State Council shall formulate and implement the national food safety risk monitoring plan.

Article 11 — The State shall establish a food safety risk assessment system, applying scientific methods to assess the possible harmful effects of biological, chemical, and physical hazards in food and food additives on human health.

Article 12 — Food safety risk assessments shall be conducted in any of the following circumstances: (1) where food safety risk monitoring reveals possible food safety hazards; (2) where it is necessary to determine the safety of a particular factor for formulating or revising food safety standards; (3) where there are other circumstances requiring food safety risk assessment as prescribed by this Law.

Article 13 — The results of food safety risk assessments shall serve as the scientific basis for the formulation and revision of food safety standards and the implementation of food safety supervision and administration. Where a food safety risk assessment concludes that a food is unsafe, the relevant authorities shall immediately announce such conclusion and inform consumers to cease purchasing or consuming the same.

Chapter III — Food Safety Standards

Article 14 — Food safety standards shall be compulsory. In addition to food safety standards, no other compulsory food standards may be formulated.

Article 15 — Food safety standards shall include: (1) limits of pathogenic microorganisms, pesticide residues, veterinary drug residues, heavy metals, contaminants, and other substances harmful to human health in food and food-related products; (2) the variety, scope of use, and dosage of food additives; (3) hygiene requirements for food for infants and other specific groups; (4) requirements for labeling, marking, and instructions relating to food safety; (5) hygiene requirements for the food production and trade process; (6) quality requirements relating to food safety; (7) food inspection methods and procedures; and (8) other items that need to be formulated as food safety standards.

Article 16 — National food safety standards shall be formulated and published by the health administration department under the State Council in conjunction with the food safety supervision and administration department under the State Council. The State Council shall standardize the numbering of national food safety standards.

Article 17 — Local food safety standards may be formulated by the health administration departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government for local specialty foods for which no national food safety standards exist, and shall be filed with the health administration department under the State Council for record.

Article 18 — Food producers may formulate enterprise standards that are stricter than national or local food safety standards. Enterprise standards shall be filed with the health administration departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government.

Chapter IV — Food Production and Trade

Article 19 — The State shall implement a licensing system for food production and trade. Enterprises engaged in food production, food distribution, and catering services shall obtain the corresponding licenses in accordance with the law. Engaging in food production or trade without a license is prohibited.

Article 20 — Food producers and traders shall establish and implement a health management system for employees. Persons suffering from diseases that may affect food safety shall not engage in work involving direct contact with food for human consumption.

Article 21 — Food producers and traders shall establish a food safety self-inspection system and regularly inspect and evaluate their food safety status. If the production and trade conditions change and no longer meet food safety requirements, food producers and traders shall immediately take corrective measures.

Article 22 — Food producers shall establish a food raw material and food additive inspection and recording system, truthfully recording the names, specifications, quantities, production dates, shelf life, and suppliers of the raw materials and food additives purchased.

Article 23 — Food producers shall establish a factory inspection and recording system for food leaving the factory, and inspect the sensory characteristics, labels, and other items of the food leaving the factory in accordance with the provisions.

Article 24 — Food producers and traders shall store food in accordance with the requirements for ensuring food safety, periodically inspect in-stock food, and promptly remove deteriorated or expired food in accordance with the provisions.

Article 25 — Food producers and traders shall establish a food recall system. Where a food producer discovers that the food it produces does not comply with food safety standards, it shall immediately cease production, recall all the food of the same batch that has been placed on the market, notify relevant producers, traders, and consumers, and record the recall and notification.

Article 26 — The production and use of food additives shall comply with relevant laws, regulations, and food safety standards. The use of food additives shall be technically necessary and proven safe and reliable through risk assessment.

Article 27 — The labels and instructions for food and food additives shall not contain false or exaggerated content, and shall not involve disease prevention or treatment functions. Food labels shall clearly indicate: the name, ingredients or list of ingredients, net content, the producer’s name, address and contact information, production date, shelf life, storage conditions, food production license number, product standard code, and other items required by laws, regulations, or food safety standards.

Article 28 — It is prohibited to produce or trade the following food, food additives, and food-related products: (1) food produced with non-food raw materials, food with chemical substances added other than those that may be legally added, or food produced with recycled food as raw materials; (2) food or food additives whose pathogenic microorganisms, pesticide residues, veterinary drug residues, heavy metals, contaminants, or other substances harmful to human health exceed the food safety standard limits; (3) food produced with food raw materials or food additives that have expired; (4) food with food additives used beyond the scope or in excess of the limits; (5) food whose nutritional content does not meet food safety standards for infants and other specific groups; (6) food or food additives that have deteriorated, are adulterated with foreign matter, or are mixed with spurious articles; (7) food produced with poultry, livestock, game animals, or aquatic products that died from disease, poisoning, or unknown causes; (8) food or food additives with labels or instructions that do not comply with provisions; and (9) other food, food additives, or food-related products that do not meet food safety standards or requirements.

Chapter V — Food Inspection

Article 29 — Food inspection institutions shall conduct inspections in accordance with relevant national certification and accreditation provisions. Only after obtaining qualifications may food inspection institutions engage in food inspection activities. Food inspection shall be conducted independently by inspectors designated by the food inspection institution.

Article 30 — Food producers and traders may conduct self-inspection of their food or entrust food inspection institutions that meet the requirements of this Law to conduct inspections.

Article 31 — Where food industry associations or consumer associations need to entrust food inspection institutions to conduct inspections of food, they shall entrust food inspection institutions that meet the requirements of this Law.

Chapter VI — Import and Export of Food

Article 32 — Imported food, food additives, and food-related products shall comply with China’s national food safety standards. Importers of food shall establish a system for verifying overseas exporters and overseas production enterprises. For the first time imported food without national food safety standards, the importer shall submit the relevant safety assessment materials to the health administration department under the State Council for examination.

Article 33 — Overseas production enterprises that export food to China shall be registered with the entry-exit inspection and quarantine authority under the State Council. Imported food shall pass inspection by the entry-exit inspection and quarantine authority, which shall issue an inspection and quarantine certificate. Customs shall release the food upon verification of the certificate.

Article 34 — Imported pre-packaged food and food additives shall have Chinese labels and Chinese instructions. Labels and instructions shall comply with the provisions of this Law and other relevant laws and administrative regulations of China and the requirements of national food safety standards, and shall indicate the country of origin and the name, address, and contact information of the domestic agent.

Article 35 — Export food production enterprises and export food raw material planting and breeding farms shall be filed with the entry-exit inspection and quarantine authority under the State Council. Exported food shall pass inspection by the entry-exit inspection and quarantine authority, which shall issue an inspection and quarantine certificate. Customs shall release the food upon verification of the certificate.

Chapter VII — Handling of Food Safety Incidents

Article 36 — 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 formulate emergency response plans for food safety incidents within their respective administrative regions in accordance with relevant laws and regulations and the emergency response plans of the people’s government at the next higher level.

Article 37 — Food producers and traders shall formulate food safety incident response plans, regularly inspect the implementation of food safety preventive measures, and promptly eliminate hidden dangers of food safety incidents.

Article 38 — Where a food safety incident occurs, the relevant entity shall immediately deal with it and prevent the incident from expanding. The entity where the incident occurs and the medical institution receiving patients for treatment shall, within two hours of the occurrence of the incident, report to the health administration department and the food safety supervision and administration department of the local people’s government at the county level.

Chapter VIII — Supervision and Administration

Article 39 — The food safety supervision and administration departments shall exercise supervision and administration over food producers and traders, and may take the following measures: (1) enter the production and trade premises for on-site inspection; (2) conduct sampling inspection of the food produced or traded; (3) consult and copy relevant contracts, bills, account books, and other materials; (4) seal or impound food, food additives, and food-related products for which there is evidence of non-compliance with food safety standards, or for which there is evidence of safety hazards, and the sites where they are illegally produced or traded.

Article 40 — The food safety supervision and administration departments shall establish a credit file for food producers and traders, recording information such as the issuance of permits, results of routine supervision and inspection, and investigation and punishment of illegal acts. For food producers and traders with poor credit records, the frequency of supervision and inspection shall be increased.

Article 41 — The food safety supervision and administration departments shall publish food safety information in accordance with the law to facilitate public access and ensure timely, accurate, and objective information disclosure.

Chapter IX — Legal Liability

Article 42 — Whoever engages in food production or trade without a permit shall have the illegal gains confiscated and be fined. Where the illegal food, food additives, or food-related products value is less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; where the value is 10,000 yuan or more, a fine of not less than 10 times but not more than 20 times the value shall be imposed.

Article 43 — Whoever produces or trades food that does not comply with food safety standards shall have the illegal gains confiscated and the illegal food, food additives, food-related products, and tools and equipment used for illegal production or trade shall be confiscated. Where the value of the illegal food, food additives, or food-related products is less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; where the value is 10,000 yuan or more, a fine of not less than 10 times but not more than 20 times the value shall be imposed; where the circumstances are serious, the license shall be revoked.

Article 44 — Where a food producer or trader purchases food raw materials or food additives without inspecting the supplier’s license and product qualification certificates, or fails to establish and comply with the inspection and recording system, the food safety supervision and administration department shall order rectification and issue a warning. Where rectification is refused, a fine of not less than 5,000 yuan but not more than 50,000 yuan shall be imposed; where the circumstances are serious, the production or trade shall be ordered to cease.

Article 45 — Where an entity responsible for a food safety incident fails to handle or report the incident in accordance with the provisions, the relevant competent department shall order rectification and issue a warning. Where the entity conceals, falsely reports, or delays reporting a food safety incident, or destroys relevant evidence, it shall be ordered to cease production or trade and a fine of not less than 100,000 yuan but not more than 500,000 yuan shall be imposed.

Article 46 — Where a food inspection institution or food inspector issues a false inspection report, the qualification of the food inspection institution shall be revoked, the food inspector shall be subject to disciplinary action or dismissal in accordance with the law, and criminal liability shall be pursued if a crime is constituted. Where a food inspection institution or food inspector issues an inspection report containing gross negligence that causes damage to the lawful rights and interests of a party, it shall bear liability for compensation.

Article 47 — Where the labels, instructions, or packaging of food or food additives do not comply with the provisions, the food safety supervision and administration department shall order rectification and confiscate the illegal gains. Where the value of the illegally produced or traded products is less than 10,000 yuan, a fine of not less than 5,000 yuan but not more than 50,000 yuan shall be imposed; where the value is 10,000 yuan or more, a fine of not less than two times but not more than five times the value shall be imposed.

Article 48 — Where food safety supervision and administration personnel abuse their power, neglect their duties, or engage in malpractices for personal gain, they shall be subject to administrative sanctions in accordance with the law. If a crime is constituted, criminal liability shall be pursued in accordance with the law.

Chapter X — Supplementary Provisions

Article 49 — For purposes of this Law: “Food” means finished products and raw materials intended for human consumption, as well as articles that are traditionally both food and medicinal substances, except for articles used solely for therapeutic purposes. “Food safety” means that food is non-toxic, harmless, meets required nutritional requirements, and does not cause any acute, sub-acute, or chronic harm to human health.

Article 50 — Specific measures for the supervision and administration of food safety in railway and civil aviation operations shall be prescribed by the relevant competent departments under the State Council.

Article 51 — This Law shall come into force on June 1, 2009. The Food Hygiene Law of the PRC shall be repealed simultaneously.

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