Order of the President of the People's Republic of China

No. 9

The Food Safety Law of the People's Republic of China, adopted at the 7th Meeting of the Standing Committee of the Eleventh National People's Congress of the People’s Republic of China on February 28, 2009, is hereby promulgated and shall go into effect as of June 1, 2009.

Hu Jintao

President of the People's Republic of China

February 28, 2009

Food Safety Law of the People's Republic of China

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

 

Table of Contents

Chapter I General Provisions

Chapter II Food Safety Risk Monitoring and Assessment

Chapter III Food Safety Standards

Chapter IV Food Production and Operation

Chapter V Food Product Inspection

Chapter VI Import and Export of Food Products

Chapter VII Dealing with Food Safety Accidents

Chapter VIII Supervision and Administration

Chapter IX Legal Liability

Chapter X Supplementary Provisions

 

Chapter I

General Provisions

Article 1 This Law is enacted for the purposes of ensuring food safety and safeguarding public health and safety.

Article 2 This Law shall be applicable to any of the following activities within the territory of the People's Republic of China:

(1) Food production and processing (hereinafter referred to as "food production"), food product distribution and catering services (hereinafter referred to as "food operation");

(2) The production and operation of food additives;

(3) The production and operation of packaging materials, containers, detergents and disinfectants used for food products, and tools or equipment used for food production and operation (hereinafter referred to as "food-related products");

(4) Food additives and food-related products used by food producers and business operators;

(5) Safety management of food products, food additives and food-related products.

The supervision of the quality and safety of primary food products derived from agriculture (hereinafter referred to as “agricultural food products”) shall abide by the provisions of the Law of the People’s Republic of China on the Quality and Safety of Agricultural Products. However, formulation of relevant quality and safety standards for agricultural food products and release of information on the safety of agricultural food products shall comply with the relevant provisions of this Law.

Article 3 Food producers and business operators shall act in compliance with the relevant laws, regulations and food safety standards, be responsible to society and the general public, ensure food safety, accept public supervision and honor their social responsibilities.

Article 4 The State Council shall set up a Food Safety Commission and set out its functions and responsibilities.

The administrative department of health under the State Council shall be responsible for the overall coordination of food safety operations, food safety risk assessment, the formulation of food safety standards, the publication of food safety related information, the formulation of qualification criteria for food product inspection bodies and inspection standards, and the organization of investigations concerning major food safety accidents.

The department of quality supervision, the administration for industry and commerce, and the food and drug administration under the State Council shall supervise and administer food production and distribution and catering services in accordance with this Law and their functions, as respectively set out by the State Council.

Article 5 The people's governments at or above the county level shall be responsible for leading, organizing and coordinating local food safety supervision and administration on a centralized basis, establishing an all-inclusive working mechanism for food safety supervision and administration, and continually improving it, guiding and directing the handling of food safety accidents on a centralized basis, implementing an accountability system for food safety supervision and administration, as well as appraising and examining the performance of food safety supervision and administration departments.

The people's governments at or above the county level shall, based on this Law and relevant provisions prescribed by the State Council, determine the duty and responsibility for food safety supervision and administration for the administrative department of health, the agricultural administrative department, the department of quality supervision, the administration for industry and commerce, and the food and drug administration at the same level. The aforementioned departments shall, within their respective duties, be held responsible for the supervision and administration of food safety in their own administrative areas.

Organizations set up by the people's governments in their subordinate administrative areas shall carry out food safety supervision and administration operations under the centralized leadership and coordination of the local people's governments.

Article 6 The administrative department of health, the agricultural administrative department, the department of quality supervision, the administration for industry and commerce, and the food and drug administration at or above the country level shall, through effective communication and close coordination, exercise their authority and fulfill their obligations in accordance with the law and the duties and responsibilities allocated to them.

Article 7 Food product associations shall work to strengthen self-regulation in the food industry, guide food producers and business operators in terms of their compliance with relevant laws and regulations, promote the establishment of a credibility system within the food industry, and popularize food safety related knowledge among the general public.

Article 8 The State shall encourage social organizations and self-governing mass organizations to popularize knowledge on laws, regulations, and standards regarding food safety, promote a healthy diet style, and enhance the consumers’ awareness of food safety and self-protection capacity. The media shall advertise laws, regulations, and standards regarding food safety as well as other relevant knowledge, and act against violations of this Law through supervision by public opinion.

Article 9 The State shall encourage and support food safety-related basic and applied research. The State shall also encourage and support food producers and business operators to adopt advanced technologies and management systems to further improve their food safety standards.

Article 10 Any entity or individual has the right to report breaches of this Law that occur during food production and operation activities, request food safety information from relevant departments, and put forward opinions and suggestions concerning the food safety supervision and administration.

 

Chapter II

Food Safety Risk Monitoring and Assessment

Article 11 The State shall set up a monitoring system to monitor food-borne diseases, food contamination and harmful elements contained in food products.

The administrative department of health under the State Council shall collaborate with other relevant departments within the State Council to work out and implement the national food safety risk monitoring scheme. Administrative departments of health under the people's governments of the provinces, autonomous regions and municipalities directly under the central government shall organize the formulation of and implement food safety monitoring plans for their own administrative areas based on the national food safety risk monitoring scheme and actual local conditions.

Article 12 After receiving information regarding a food safety risk, the agriculture administration, the department of quality supervision, the administration for industry and commerce, the state food and drug administration and other relevant departments shall report immediately to the administrative department of health under the State Council, which shall verify the risks reported together with other relevant departments and revise the food safety risk monitoring scheme accordingly.

Article 13 The State shall set up a risk assessment system on food safety to carry out risk assessments on biological, chemical and physical hazards contained in food products and food additives.

The administrative department of health under the State Council shall be responsible for the organization of food safety risk assessments, and shall set up food safety risk assessment expert commissions consisting of specialists in medicine, agriculture, food and nutrition to conduct such assessments.

Members of the food safety risk assessment expert commission shall be involved in safety risk assessments of pesticides, fertilizers, growth regulators, veterinary drugs, forage and feed additives, etc.

Food safety risk assessments shall be scientifically grounded and conducted on the basis of relevant information, including the information produced by food safety risk monitoring operations and scientific statistics.

Article 14 When the administrative department of health under the State Council, through the monitoring of food safety risks or on receipt of a report, finds potential food safety hazards, it shall carry out immediate investigations and risk assessments.

Article 15 The agricultural administrative department, the department of quality supervision, the administration for industry and commerce, the food and drug administration and other relevant departments under the State Council shall provide the administrative department of health under the State Council with advice concerning food safety risk assessment as well as other relevant information and materials.

The administrative department of health under the State Council shall notify other relevant departments under the State Council of the results of food safety risk assessments.

Article 16 The results of food safety risk assessments provide a scientific ground on which the formulation and revision of food safety standards and food safety supervision and administration shall be based.

In the case of food products being classified as unsafe through food safety risk assessments, the department of quality supervision, the administration for industry and commerce, and the food and drug administration under the State Council shall, according to their respective duties, immediately take necessary measures to ensure such products are suspended from production, and notify consumers to stop eating such products. The administrative department of health under the State Council shall immediately formulate or revise relevant national food safety standards when necessary.

Article 17 The administrative department of health under the State Council, together with other departments under the State Council, shall carry out comprehensive analysis of relevant food safety operations on the basis of the results of food safety risk assessments and monitoring outcomes. If comprehensive analysis reveals a particular food product presents a considerably high degree of risk, the administrative department of health under the State Council shall, in a timely manner, issue a food safety warning about such product and publish it.

 

Chapter III

Food Safety Standards

Article 18 Food safety standards shall be formulated for the purpose of safeguarding public health, and shall therefore be scientific and rational as well as safe and reliable.

Article 19 Food safety standards are compulsory standards. No compulsory standards other than food safety standards shall be formulated for food products.

Article 20 Food safety standards shall include the following:

(1) Limits imposed on pathogenic microbes, pesticide residues, residues of veterinary drugs, heavy metal elements, pollutants, and other harmful substances contained in food products and food-related products;

(2) Requirements concerning the categories, usage range and dosage of food additives;

(3) Nutritional requirements for food products intended for infants, children, or other specific consumer groups;

(4) Requirements concerning food safety and nutrition labels, markings and user instructions;

(5) Hygiene requirements for food production and operation;

(6) Quality requirements relating to food safety;

(7) Food product inspection methods and procedures;

(8) Other content that needs to be incorporated into food safety standards.

Article 21 The administrative department of health under the State Council shall be responsible for the formulation and publication of national food safety standards, the national standard code of which shall be determined by the standardization authorities of the State Council.

The administrative department of health and the agricultural administrative department under the State Council are responsible for setting the upper limits on pesticide and veterinary drug residues contained in food products and the testing methods and procedures thereof.

Examination procedures for slaughtered livestock shall be set out by the relevant departments together with the administrative department of health under the State Council.

Information related to food safety contained in other national standards shall be consistent with relevant provisions set out in the national food safety standards.

Article 22 The administrative department of health under the State Council shall collect mandatory standards contained in existing quality and safety standards for agricultural food products, hygiene and quality standards for food products and other relevant standards for the food industry, and incorporate them into the national food safety standards to be published.

Until the publication of the aforementioned national food safety standards, food producers and business operators shall conduct food-related business in compliance with existing quality and safety standards for agricultural food products, hygiene and quality standards for food products, and other relevant standards for the food industry.

Article 23 The national food safety standards shall be endorsed by the review committee of national food safety standards, which is staffed by specialists in medicine, agriculture, food, nutrition, etc., and representatives from relevant departments under the State Council.

The national food safety standards shall be formulated on the basis of the results of food safety risk assessments, by means of consultation with relevant international standards and the outcomes of international food safety assessments and taking into full account the results of quality and safety assessments for agricultural food products. The opinions of consumers, food producers and business operators shall also be heard.

Article 24 Where national food safety standards are absent local food safety standards may be formulated.

The administrative department of health under the people's governments of the provinces, autonomous regions and municipalities directly under the central government shall formulate local food safety standards by consulting the provisions on the formulation of national food safety standards as prescribed in this Law. Local food safety standards shall be filed with the administrative department of health under the State Council.

Article 25 In the case of food products which are not covered by either the national or local food safety standards, the food production enterprise concerned shall formulate internal food safety standards to serve as the basis for relevant production operations. Food production enterprises are encouraged by the State to set out corporate internal food safety standards stricter than their national or local counterparts. Internal food safety standards formulated by food enterprises shall be filed with provincial administrative departments of health and applied within such enterprise.

Article 26 Food safety standards shall be made available to the public free of charge.

 

Chapter IV

Food Production and Operation

Article 27 As well as food safety standards, food production and operation shall comply with the following requirements:

(1) Food producers and business operators shall have proper premises for raw material processing, food processing, packaging and storage, etc. consistent with the categories and amount of food products being manufactured or sold, and these premises shall be clean and separated from toxic or harmful areas or other sources of pollution according to relevant prescribed distance requirements;

(2) Food producers and business operators shall have production equipment or facilities consistent with the categories and amount of food products being manufactured or sold as well as other necessary equipment or facilities, e.g., disinfectants, locker room, toilet facilities, lighting, ventilation, antiseptic, dust, fly, rat, and insect prevention equipment or facilities, and washing, water-treatment and garbage and waste disposal equipment or facilities;

(3) Food production and operation shall be staffed by professional technicians and management personnel and have relevant rules to ensure food safety;

(4) The equipment layout and technical process shall be rationally designed to prevent cross infection between unprocessed food and ready-made food products, or between ingredients and finished products, as well as to protect food products against toxic or infected objects;

(5) Food serving utensils and containers for ready-made food products shall be washed and disinfected before use, and cooking utensils shall be kept clean and be washed after each use;

(6) Containers, tools and equipment used for the storage, transportation, and loading or unloading of food products shall be safe and free of harmful substances and be kept clean to protect food products from cross-contamination, meet special food safety requirements such as temperature criteria. Food products shall not be transported alongside toxic or harmful objects;

(7) Small packaging or clean and toxicant-free packaging materials and containers shall be used for ready-made food products;

(8) Staff members of food production and operation enterprises shall maintain good personal hygiene, wash their hands and wear clean uniforms throughout the food production and operation process; toxicant-free and clean utensils shall be used while selling unpackaged ready-made food products;

(9) Water used for food production and operation shall meet the national hygienic standard prescribed for drinking water;

(10) Detergents and disinfectants used for food production and operation shall be safe and harmless to the human body; and

(11) Other requirements specified under relevant laws and regulations.

Article 28 Production or operation in any of the following food products is prohibited by law:

(1) Food products made by using non-food ingredients or recycled food products, food products which have been added with chemical substances other than food additives, or other substances which are potentially harmful to the human body;

(2) Food products in which the contents of pathogenic microbes, pesticide residues, residues of veterinary drugs, heavy metal elements, pollutants, or other substances harmful to the human body are higher than the relevant food safety limits;

(3) Food products intended for infants, children and other specific consumer groups whose nutritional ingredients fail to meet relevant food safety standards;

(4) Putrid, spoiled, moldy, unclean, impure, contaminated, adulterated food products, and food products whose usual sensory properties have changed;

(5) Meat of animals (including poultry, livestock, wild animals and aquatic animals) which die from diseases, poisoning or unknown causes and food products processed therefrom;

(6) Meat and products processed therefrom, which have not been quarantined by animal hygiene supervision organizations or failed the inspection test;

(7) Food products contaminated by packaging materials, containers or transportation vehicles, etc.;

(8) Food products which have exceeded their shelf life;

(9) Unlabeled prepackaged food products;

(10) Food products whose production or operation are prohibited by the State due to special requirements such as disease prevention; or

(11) Other food products which fail to satisfy relevant food safety standards or requirements.

Article 29 The licensing system is adopted by the State for the production and operation of food products. Food producers and distributors and catering service providers shall, pursuant to law, apply for the food production license, food distribution license and catering service license respectively.

The food distribution license is not required for food producers who have been issued with the food production license to sell their own food products in their production premises; neither the food production license nor the food distribution license is required for licensed catering service providers to sell food products made or processed by them on their own premises; farmers selling their own agricultural food products do not need to apply for the food distribution license.

Small food production or processing workshops and food vendors shall act in compliance with relevant food safety requirements set out in this Law, which are consistent with their actual business scale and conditions, and ensure that food products made or sold by them are hygienic, toxicant-free and harmless. Relevant governmental authorities shall strengthen the supervision and administration of such food workshops and vendors, and specific administrative measures shall be formulated, based on this Law, by standing committees of the people's congresses of provinces, autonomous regions, and municipalities directly under the central government.

Article 30 The people's governments at or above the county level shall encourage small food production and processing workshops to improve their working conditions, and support food vendors to do business in centralized trading markets, shops, and other permanent premises.

Article 31 The department of quality supervision, the administration for industry and commerce, and the food and drug administration at or above the country level shall examine and verify, in accordance with the Administrative Permission Law of the People's Republic of China, the supporting materials submitted by the applicants as are required in Subparagraphs (1) through (4) of Article 27 of this Law, and carry out, where necessary, on-site inspections of the applicants' business premises. Licenses shall be issued to qualified applicants, and in the case of unqualified applicants, their applications shall be rejected and they shall be notified in writing of the reasons.

Article 32 Food production and operation enterprises shall establish and improve internal food safety management systems, strengthen staff training focused on food safety issues, employ full-time or part-time food safety administrators, ensure the standard of food product inspection operations, and conduct food production and operation activities according to the law.

Article 33 Food production and operation enterprises are encouraged by the State to comply with relevant production standards, implement hazard analysis and Critical Control Point (CCP) systems, and improve the quality of food safety management.

In the case of food production and operation enterprises which have been properly certified in terms of production standards, hazard analysis and a CCP system, relevant accreditation organizations shall carry out follow-up inspections pursuant to law, and revoke accreditations issued to food enterprises which no longer meet the certification criteria. Disqualified food enterprises shall be reported immediately to the relevant department of quality supervision, the administration for industry and commerce and the food and drug administration, and relevant information shall be disclosed to the general public. Accreditation organizations shall not charge food enterprises for follow-up inspections.

Article 34 Food producers and business operators shall establish and effectively implement health management regulations for personnel engaging in food production and operation. Personnel suffering from dysentery, typhoid, viral hepatitis or other diseases of the digestive tract, and those with active tuberculosis, suppurative or exudative skin diseases, or other diseases which may affect food safety are prohibited from engaging in work involving ready-made food products.

Personnel engaged in food production and operation shall undergo health checks on a yearly basis, and health certificates shall be obtained before being allowed to work.

Article 35 Producers of agricultural food products shall use pesticides, fertilizers, growth regulators, veterinary drugs, feed, and feed additives, and other agriculture additives in accordance with the food safety standards and relevant regulations of the State. Production enterprises of agricultural food products and specialized farmers' cooperative economic organizations shall establish a recording system for agricultural food production activities.

Agriculture departments at or above the county level shall strengthen the administration of and guidance for using agricultural additives, and set up sound safety regulations concerning the usage of agricultural additives.

Article 36 While purchasing food ingredients, food additives or food-related products, food producers shall verify the license and product quality certificates of the suppliers. Food ingredients for which product quality certificates cannot be provided shall be examined according to the food safety standards. Food producers are prohibited from purchasing or using food ingredients, food additives or food-related products which do not meet relevant food safety standards.

Food production enterprises shall establish a purchase examination recording system for food ingredients, food additives and food-related products, accurately recording information relevant to each purchase transaction, including the name, specification, quantity, supplier name and contact details, and date of purchase of food ingredients, food additives and food-related products, etc.

Purchase examination records concerning food ingredients, food additives and food-related products shall be truthful and be properly kept for a minimum of two years.

Article 37 Food production enterprises shall establish a pre-delivery examination recording system for food products, checking quality certificates and food safety conditions and accurately recording relevant pre-delivery details, such as the name, specification and quantity of food products, date of production, batch number, number of quality certificates, name and contact details of the purchasers, and date of sale.

Pre-delivery examination records shall be truthful and be properly kept for a minimum of two years.

Article 38 Producers of food products, food additives and food-related products shall carry out examinations on their products (including food products, food additives and food-related products) in accordance with food safety standards. Goods shall only be transported or sold after passing examination.

Article 39 While purchasing food products, food business operators shall verify the licenses and product quality certificates of suppliers.

Food operation enterprises shall establish a purchase examination recording system for food products being purchased and accurately record the name, specification, amount, batch number and shelf life of food products as well as the name and contact details of suppliers, and the date of purchase, etc.

Food product purchase examination records shall be truthful and be properly kept for a minimum of two years.

In the case of food operation enterprises that adopt the operating mode of centralized distribution, the verification of the licenses and product quality certificates of the suppliers and the purchase examination recording, shall be carried out by the headquarters on a centralized basis,

Article 40 Food business operators shall store food products in accordance with relevant food safety requirements, check food products in stock on a regular basis, and dispose of spoiled or expired products in a timely manner.

Article 41 As regards the storage of unpackaged food products, details of the products such as the name, date of production, shelf life, name and contact information of producer, shall be clearly indicated by the food business operators at the storage sites.

Food business operators selling unpackaged food products shall mark product details such as the name, date of production, shelf life, name and contact information of the producer and operator on the container or the outer package. Article 42 The outer package of pre-packed food products shall be labeled with the following information:

(1) Product name, specification, net weight, date of production;

(2) Ingredients or formula;

(3) Name, address and contact details of the producer;

(4) Shelf life;

(5) Standard code of the product;

(6) Storage instructions;

(7) Names of food additives used which have been acknowledged in the national standards;

(8) Production license number;

(9) Other information as required by relevant laws, regulations and food safety standards.

Labels of food products intended for infants, children and other specific consumer groups shall also contain information of key nutritional ingredients and their contents.

Article 43 The licensing system is adopted by the State for the production of food additives. Eligibility criteria and procedures for additive production applications shall be carried out in accordance with relevant provisions of the State concerning the administration of production licenses for industrial products.

Article 44 Entities or individuals applying to produce food products using new food ingredients, or new categories of food additives or food-related products shall submit relevant food safety assessment materials to the administrative department of health under the State Council, which is responsible for verifying food safety assessment materials submitted within 60 days after receipt of the applications. Licenses shall be issued to applicants who meet relevant food safety standards in accordance with the law and the information shall be disclosed to the public. In the case of unqualified applicants, their applications shall be rejected and they shall be notified in writing of the reasons.

Article 45 Only food additives which are technically necessary and have been proven safe and reliable through food safety risk assessments can be categorized for use for the manufacturing of food products. The administrative department of health under the State Council shall revise relevant contents concerning the category, usage range and dosage standard of food additives based on technical necessity and the results of food safety risk assessments.

Article 46 Food producers shall use food additives in compliance with provisions relating to the category, usage range and dosage of food additives set out in the food safety standards. Under no circumstance shall food producers use chemical ingredients or other potential harmful substances other than food additives for the manufacturing of food products.

Article 47 Food additives shall be labeled and packaged with user instructions. Apart from the usage range, dosage and usage instructions, labels and user instructions for food additives shall contain matters listed in Subparagraph (1) through (6), (8) and (9) of Article 42 of this Law. In addition, labels of food additives shall be indicated with the words "food additive."

Article 48 Labels and user instructions for food products or food additives shall not contain false or exaggerated information. Neither shall they indicate disease prevention or treatment functions. Food producers shall be held responsible for information provided on the labels and user instructions.

Labels and user instructions of food products and food additives shall be explicit, easily noticeable and legible.

It is prohibited to sell food products and food additives which are inconsistent with the information contained on their labels or user instructions.

Article 49 Food business operators shall sell pre-packaged food products according to the requirements in the warning labels or instructions printed on the labels.

Article 50 Food products shall not contain any medicinal materials, but may be added to materials traditionally used both as food and Chinese medicine. Catalogue of materials traditionally used both as food and medicinal materials shall be formulated and published by the administrative department of health under the State Council.

Article 51 The State shall exercise strict supervision of food products which claim to have specific health benefits. The relevant supervisory bodies shall assume responsibility and fulfill their duties in accordance with the law. Specific managerial measures will be formulated by the State Council.

Food products which claim to have specific health benefits shall not have any acute, sub-acute or chronic harmful effects on the human body. Labels and user instructions of such products shall not be indicative of disease prevention or treatment functions, and information contained therein shall be truthful and contain details of suitable and unsuitable user groups, and the contents of functional or representative elements, etc. Functions and ingredients of the products must be consistent with the information contained on their labels and user instructions.

Article 52 Founders of market houses, counter and stall owners and organizers of trade fairs shall check and verify the licenses of food business operators who intend to do business on such premises, clarify the latter’s responsibilities for food safety management and carry out regular inspections of the operating conditions. Where they discover any violations of this Law by food business operators, they shall put an end to such violations immediately and, without delay, report such cases to the local administration department of industry and commerce or food and drug administration at the county level.

Founders of market houses, counter and stall owners and organizers of trade fairs shall bear joint and several liability in the case of food safety accidents resulting from their failure to fulfill the responsibilities specified in the preceding paragraph.

Article 53 The State shall establish a recall system for food products. Where food producers find that the food products they produce are inconsistent with the food safety standards, they shall immediately suspend the production of such food products, recall substandard food products which have already been released onto the market, notify the relevant food producers, business operators and consumers, and record the recall and notification details properly.

Food business operators shall immediately stop operations concerning food products which are found to be inconsistent with the food safety standards, and notify the relevant food producers and operators as well as consumers accordingly. Details of the sales suspension and relevant notifications shall be properly recorded. Product recalls shall be issued immediately if the food producers deem a recall necessary.

Food producers shall take the necessary measures such as remedy, decontamination treatment or destruction with respect to the food products which have been recalled, and relevant information about the recall and the treatment shall be reported to the administration department of quality supervision at or above the county level.

Where food producers and food business operators fail, in accordance with this Article, to recall or stop operations concerning food products which are found to be inconsistent with the food safety standards, the department of quality supervision, the administration for industry and commerce or the food and drug administration at or above the county level may order such producers or business operators to recall or stop operations relating to the food products concerned.

Article 54 Advertisements for food products shall be true and conform to relevant laws. Neither false or exaggerated information nor indications of disease prevention or treatment functions are allowed in food advertisements. Food safety supervision and administration departments, food product inspection bodies, food product associations, and consumer associations shall not recommend food products to the public, whether through advertisements or otherwise.

Article 55 In the case of entities or individuals recommending food products in false advertisements which have resulted in damages to the lawful rights and interest of the consumers, they shall bear joint and several liability with relevant food producers or operators.

Article 56 The local people's governments encourage large-scale food production as well as chain operations and distribution of food products.

 

Chapter V

Food Product Inspection

Article 57 Unless otherwise stipulated by law, food product inspections shall be carried out only by food product inspection bodies which have obtained qualification certificate in accordance with relevant accreditation and certification regulations of the State.

Qualification criteria and inspection standards for food product inspection bodies shall be set out by the administrative department of health under the State Council.

Food product inspection bodies that are established upon approval of relevant departments in charge under the State Council or certified according to the law before the enforcement of this Law may continue to conduct food product inspection operations in accordance with the provisions set out in this Law.

Article 58 Food product inspections shall be carried out by inspectors designated by the inspection bodies on an independent basis.

Food inspectors shall carry out food product inspections in compliance with relevant laws and regulations, food safety standards and inspection rules, respecting science and following professional ethics, to ensure that the resultant data and conclusions are objective and impartial. Food inspectors shall, under no circumstances, produce false inspection reports.

Article 59 A responsibility system shall be applied in food product inspection, under which food product inspection bodies and inspectors are accountable for the inspection of food products, including the inspection reports issued by them. Food product inspection reports shall be sealed by the inspection bodies and also be signed or sealed by the inspectors concerned.

Article 60 Inspection exemption shall not be granted to any food product by food safety supervisory departments.

The department of quality supervision, administration for industry and commerce and food and drug administration at or above the county level shall inspect samples from food products on a regular or random basis. These tests shall be conducted free of charge, and the test samples shall be purchased products.

Where the department of quality supervision, the administration for industry and commerce, and the food and drug administration at or above the county level need to inspect food products during the process of law enforcement, they shall entrust such inspection to the food product inspection bodies which meet the requirements prescribed in this Law and pay relevant fees. A second test may be conducted in accordance with the law for food products the inspection conclusions of which are disputed.

Article 61 Food production and operation enterprises may carry out inspections on food products produced by them. Alternatively, they may also entrust such inspections to food product inspection bodies which meet the requirements prescribed in this Law.

In cases where a food product inspection is required by such an organization as food product association or by a consumer, the organization or consumer in question shall entrust an inspection organization which meets the requirements prescribe in this Law for that purpose.

 

Chapter VI

Import and Export of Food Products

Article 62 Imported food products, food additives and food-related products shall satisfy relevant requirements prescribed by the national food safety standards.

Imported food products shall pass examinations conducted by entry-exit inspection and quarantine authorities and pass the customs by virtue of the customs clearance certificate issued by entry-exit inspection and quarantine authorities.

Article 63 With respect to the import of food products which are not covered by the national food safety standards or new categories of food additives or food-related products which have not been previously imported, the importers shall apply to the administrative department of health under the State Council for approval, enclosing relevant food safety assessment materials. The administrative department of health under the State Council shall process such applications based on Article 44 of this Law and formulate new national food safety standards accordingly.

Article 64 In case food safety accidents happen outside China which are potentially relevant to the Chinese food market or serious food safety issues are encountered among food imports, the entry-exit inspection and quarantine authorities shall issue an early warning or implement control measures in a timely manner, and report such cases to the administrative department of health, the agricultural administrative department, the administration for industry and commerce and the food and drug administration, under the State Council. The departments receiving such reports shall adopt immediate counter measures accordingly on receipt of such reports.

Article 65 Food exporters and their agencies that export food products to China shall file their information with national entry-exit inspection and quarantine authority. Overseas producers of food products which are exported to China shall register with national entry-exit inspection and quarantine authority.

National entry-exit inspection and quarantine authority shall publish lists of registered exporters, export agencies and overseas food producers on a regular basis.

Article 66 Pre-packaged food products imported to China shall have labels and user instructions in Chinese language. The aforesaid labels and user instructions shall be in compliance with the provisions of this Law and other relevant laws and administrative regulations as well as the requirements of the national food safety standards, and shall contain the place of origin and the name, address and contact details of the Chinese sales agency. It is prohibited to import pre-packaged food products without Chinese language labels or Chinese language user instructions or whose labels or user instructions fail to meet the provisions specified under this Article.

Article 67 Food importers shall establish a food import and sales recording system to accurately record relevant information concerning imported food products, such as the name, specification, imported amount, date of production, production or import batch number, shelf life, the name and contact details of exporters and purchasers, and the delivery date, etc.

Records of food imports and sales shall be truthful and be properly kept for a minimum of two years.

Article 68 Food exports shall be monitored and be tested on a random basis by national entry-exit inspection and quarantine authority, and be released by the customs by virtue of the customs clearance certificate issued by entry-exit inspection and quarantine authorities.

Producers of food products for export and relevant raw food material suppliers such as plant or animal breeding enterprises shall file with national entry-exit inspection and quarantine authority.

Article 69 National entry-exit inspection and quarantine authority shall collect and gather food safety information concerning imported and exported food products, and report such information to relevant authorities, organizations and enterprises in a timely manner.

National entry-exit inspection and quarantine authority shall keep credibility records for food importers and exporters and producers of export food products, and publicize such records. More stringent inspection and quarantine measures shall be adopted for food importers and exporters and producers of export food products with poor credibility histories.

 

Chapter VII

Dealing with Food Safety Accidents

Article 70 The State Council is responsible for the formulation of national food safety contingency plans.

The local people's governments at or above the county level shall work out local contingency plans for food safety accidents in accordance with relevant laws and regulations, food safety contingency plans set out by the people's governments at higher levels, and based on the actual local conditions. Local food safety contingency plans shall be filed with the people's governments at the next higher level.

Food production and operation enterprises shall formulate internal plans for dealing with food safety accidents, examine the implementation of food safety measures on a regular basis, and eliminate food safety hazards in a timely manner.

Article 71 The enterprise where a food safety accident occurs shall immediately take measures to prevent such accident from escalating. Such enterprise and medical institutions responsible for the treatment of patients shall immediately report to the county-level administrative department of health in the place where the accident occurs.

The agricultural administrative department, the department of quality supervision, the administration for industry and commerce and the food and drug administration shall immediately notify the administrative department of health of food safety accidents reported or discovered during routine supervision operations.

In the event of a major food safety accident, after being informed of the accident, the county-level administrative department of health shall, based on relevant regulations, report to the local people's government and administrative department of health under the people's governments at higher levels, which shall then report the case to the authorities at higher levels in accordance with relevant regulations.

Under no circumstances shall an entity or individual cover up or give false information about food safety accidents, or delay reporting such accidents. Nor shall they destroy relevant evidence.

Article 72 After being informed of a food safety accident, the administrative department of health at or above the county level shall carry out investigations jointly with the agricultural administrative department, the department of quality supervision and the administration for industry and commerce and the food and drug administration, and take the following measures to prevent or relieve adverse social effects:

(1) Carry out emergency rescue operations--people injured as a result of food safety accidents shall be treated immediately by the relevant administrative department of health;

(2) Food products and ingredients suspended of having caused food safety accidents shall be sealed and tested immediately; with respect to confirmed cases of contaminated food products or ingredients, relevant food producers shall be ordered to recall, suspend production of, and destroy food products in accordance with provisions set out in Article 53 of this Law;

(3) Utensils and equipment used for contaminated food products shall be sealed, and an order shall be given to have them washed and disinfected; and

(4) Conduct effective disclosure of information concerning food safety accidents and the treatment thereof in accordance with the law, and explain potentially harmful effects of accidents to the public.

In the event of a major food safety accident, the relevant people's government at or above the county level shall set up an accident control center and activate relevant contingency plans. Major food safety accidents shall be handled in accordance with the provisions set out in the preceding paragraph.

Article 73 In the event of a major food safety accident, the administration department of health under the people's government at or above the level of a city divided into districts shall carry out accident investigations jointly with other relevant departments, urge the relevant departments to fulfill their duties, and report to the people's government at the same level on the investigation and handling of the accident.

In the event of a food safety accident involving two or more provinces, autonomous regions or municipalities directly under the Central Government, the administration department of health under the State Council shall be responsible for organizing relevant accident investigation in accordance with the preceding paragraph.

Article 74 In the event of a food safety accident, disease prevention and control authority at or above the county level shall assist the administrative department of health and other relevant departments with the sanitation treatment of the accident scene, and carry out epidemiologic investigations of factors relevant to the accident.

Article 75 In investigation of a food safety accident, in addition to the legal liability of the entity to which the accident has occurred, food safety accident investigations shall also examine the case for dereliction of duty on the part of staff members of relevant supervisory and regulatory bodies and accreditation organizations.

 

Chapter VIII

Supervision and Administration

Article 76 The local people's governments at or above the county level shall organize the administrative department of health, the agricultural administrative department, the department of quality supervision, the administration for industry and commerce, and the food and drug administration at the same level to formulate the yearly food safety supervision and administration plan for their own administrative areas, and conduct relevant food safety operations accordingly.

Article 77 The department of quality supervision, the administration for industry and commerce, and the food and drug administration at or above the county level shall have the power to take any of the following measures during food safety related supervision operations:

(1) Enter production and business premises to conduct on-site inspections;

(2) Test samples from food products;

(3) Check and copy relevant contracts, bills, accounting books or other relevant materials;

(4) Seal and detain food products which are found to be in violation of food safety standards, illegal raw food materials, food additives and food-related products, tools and equipment used for illegal production activities, and contaminated tools and equipment; and

(5) Close down premises for illegal food production and operation activities. Agricultural administrative departments at or above the county level shall supervise and administer agricultural food products in accordance with their official duties specified under the Law of the People's Republic of China on the Quality and Safety of Agricultural Products.

Article 78 During the supervision and inspection of food producers and business operators, the department of quality supervision, the administration for industry and commerce and the food and drug administration at or above the county level shall record relevant supervision and inspection details as well as investigation outcomes. Such records shall be archived after being signed by supervision and inspection personnel and food producers or business operators.

Article 79 The department of quality supervision, the administration for industry and commerce and the food and drug administration at or above the county level shall keep food safety credibility records for food producers and business operators, including a record of issued licenses, results of routine supervision and inspections, and investigation outcomes in the case of illegal activities. The frequency of food safety supervisions and inspections shall be increased for food producers or business operators with a poor credibility history.

Article 80 In cases that the administrative department of health, the department of quality supervision, the administration for industry and the commerce and food and drug administration at or above the county level receive public enquiries, complaints and reports, they shall promptly reply, verify and process those which fall within their scope of responsibility, and, for those public enquiries, complaints and reports which are not within their jurisdiction, they shall notify in writing the applicable departments and transfer them respectively. The applicable departments shall be responsible for promptly dealing with such cases without buck-passing. Cases confirmed as food safety accidents shall be handled in accordance with the provisions set out in Chapter VII of this Law.

Article 81 The administrative department of health, the department of quality supervision, the administration for industry and commerce, and the food and drug administration at or above the county level shall fulfill their duties concerning food safety supervision and administration in compliance with their legal authority and procedures; a food producer or business operator shall not be given an administrative fine more than twice for the same offence; cases involving crimes shall be transferred to the public security authorities according to the law.

Article 82 The State shall establish a centralized food safety information disclosure system. The following information shall be publicized by the administrative department of health under the State Council on a centralized basis:

(1) The overall food safety conditions in China;

(2) Information about food safety assessments and risk warnings;

(3) Major food safety accidents and how such accidents are dealt with;

(4) Other food safety information which is of significance or is required by the State Council to be disclosed on a centralized basis.

Information listed under Subparagraphs (2) and (3) of the preceding paragraph may also be publicized by the administrative department of health under the people's governments of the provinces, autonomous regions or municipalities directly under the central government, subject to their impacts being limited to certain regions. The agricultural administrative department, the department of quality supervision, the administration for industry and commerce, and the food and drug administration at or above the county level shall publicize information concerning routine food safety supervision and administration in accordance with their respective official duties.

Relevant information shall be publicized by food safety supervisory and regulatory authorities in an accurate, objective and timely manner.

Article 83 Information which need be publicized on a centralized basis as required by the first paragraph of Article 82 of this Law shall be reported by the administrative department of health, the agricultural administrative department, the department of quality supervision, the administration for industry and commerce, or the food and drug administration at or above the county level to the relevant departments at higher levels, which shall, in turn, promptly report it to the administrative department of health under the State Council. Where necessary, such information may also be reported directly to the administrative department of health under the State Council by the said local departments.

The administrative department of health, the agricultural administrative department, the department of quality supervision, the administration for industry and commerce, and the food and drug administration at or above the county level shall exchange food safety information.

 

Chapter IX

Legal Liability

Article 84 With respect to violations of this Law, unlicensed food production or operation activities or unlicensed production of food additives, relevant departments shall, based on their respective official duties, confiscate illegal income, food products and food additives produced or under operation in violation of the law, and tools, equipment, raw materials and other articles used for illegal production and operation activities. A fine of not less than RMB 2,000 yuan but not more than RMB 50,000 yuan shall also be imposed, in cases where the total value of illegal food products and/or food additives involved is less than RMB 10,000 yuan; otherwise, the fine shall be up to ten times—but not less than five times—the total value of illegal food products and /or food additives involved.

Article 85 In the case of violations of this Law to which any of the following applies, competent departments shall, based on their respective official duties, confiscate illegal income, food products produced or distributed in violation of the law, and tools, equipments, raw materials and other articles used for illegal production and operation activities. A fine of not less than RMB 2,000 yuan but not more than RMB 50,000 yuan shall also be imposed in cases where the total value of illegal food products involved is less than RMB 10,000 yuan; otherwise, the fine shall be not less than five times but not more than ten times the total value of illegal food products involved. Where circumstances are serious, a license revocation shall be imposed.

(1) Using non-food ingredients and recycled food products for the production of food products, or adding chemical substances other than food additives and other harmful substances to food products;

(2) Engaging in the production and operation of food products in which the contents of pathogenic microbes, pesticide residues, residues of veterinary drugs, heavy metal elements, pollutants, or other harmful substances are higher than the relevant limits set by food safety standards;

(3) Engaging in the production or operation of food products intended for infants, children or other specific consumer groups whose nutritional ingredients fail to meet relevant food safety standards;

(4) Engaging in the operation of putrid, spoiled, moldy, unclean, impure, contaminated, adulterated food products, or food products whose usual sensory properties have changed;

(5) Engaging in the operation of meat of poultry, livestock, beasts or aquatic animals which die from diseases, poisoning or unknown causes, or the production or operation of the food products processed therefrom;

(6) Engaging in the operation of meat products or production or operation of meat products processed therefrom, which have not been quarantined by animal hygiene supervision authorities or failed the inspection test;

(7) Engaging in the operation of food products which have exceeded their shelf life;

(8) Engaging in the production or operation of food products which are prohibited by the State due to disease prevention considerations;

(9) Engaging in the production of food products using new ingredients, or the production of new categories of food additives or new categories of food-related products, without first going through relevant food safety assessments; or

(10) Food producers or business operators who refuse to recall or suspend the operation of certain food products which do not meet the food safety standards on the orders of the relevant departments in charge.

Article 86 In the case of violations of this Law to which any of the following applies, the relevant departments shall, based on their respective official duties, confiscate illegal income, food products produced or distributed in violation of law, and tools, equipments, raw materials and other articles used for illegal production and operation activities. A fine of not less than RMB 2,000 yuan but not more than RMB 50,000 yuan shall also be imposed, in cases where the total value of illegal food products involved is less than RMB 10,000 yuan; otherwise, the fine shall be not less than two times but not more than five times the total value of illegal food products involved. Where circumstances are serious, the suspension of production and operation or even license revocation shall be imposed.

(1) Engaging in the operation of food products contaminated by packaging materials, containers or transportation vehicles, etc;

(2) Engaging in the production or operation of unlabeled pre-packaged food products or food additives, or food products or food additives whose labels and user instructions fail to meet relevant requirements set out in this Law;

(3) A food producer purchasing or using raw food materials, food additives or food-related products which fail to meet the food safety standards; or

(4) A food producer or operator adding medicinal materials to food products.

Article 87 In the case of violations of this Law to which any of the following applies, the relevant departments shall, based on their respective official duties, order the offender to make corrections and issue a warning. Where the offender refuses to make corrections, a fine of not less than RMB 2,000 yuan but not more than RMB 20,000 yuan shall be imposed. Where circumstances are serious, the suspension of production, suspension of operations or even license revocation shall be imposed.

(1) Failure to carry out inspections of food ingredients purchased, or food products, food additives or food-related products manufactured;

(2) Failure to establish or comply with relevant purchase or pre-delivery examination recording systems;

(3) Failure to file corporate internal food safety standards in accordance with provisions set out in this Law;

(4) Failure to store or sell food products or conduct food stocktaking in accordance with relevant regulations;

(5) Failure to verify licenses or other certificates when making purchase;

(6) Having labels and user instructions on food products that indicate disease prevention or treatment functions; or

(7) Engaging people diagnosed with any of the diseases listed under Article 34 of this Law to deal with ready-made food products.

Article 88 In the case of food producers or business operators, in violation of this Law, failing to take necessary measures or fulfill their accident report obligations after the occurrence of food safety accidents, relevant departments shall, based on their respective official duties, order the offender to make corrections and issue a warning. For cases involving evidence destruction, the suspension of production and operation as well as a fine of not less than RMB 2,000 yuan but not more than RMB 100,000 yuan shall be imposed. For cases which have resulted in severe consequences, license revocation shall be enforced by the original issuing body.

Article 89 In the case of violations of this Law to which any of the following applies, penalties shall be imposed in accordance with relevant provisions set out under Article 85 of this Law.

(1) Importing food products which fail to meet the national food safety standards of China;

(2) Importing food products which are not covered by the national food safety standards, or importing new categories of food additives or food-related products which have not been previously imported without first undergoing food safety assessments; or

(3) Food exporters failing to export food in compliance with this Law. Where food importers, in violation of the provisions of this Law, fail to establish or comply with food import or sales recording systems, penalties shall be imposed in accordance with provisions set out under Article 87 of this Law.

Article 90 With respect to founders of market houses, stall owners and organizers of trade fairs who, in violation of the provisions of this Law, have granted admission to unlicensed food business operators or failed to fulfill relevant verification or reporting obligations, the relevant departments shall, based on their respective official duties, impose a fine of not less than RMB 2,000 yuan but not more than RMB 50,000 yuan. For cases which have resulted in severe consequences, business suspension shall be imposed and license revocation shall be enforced by the original issuing body.

Article 91 In the case of transporting food products in violation of the relevant requirements of this Law, relevant authorities shall, based on their respective official duties, order the offender to rectify the situation and issue a warning; where the offender refuses to rectify the situation, suspension of production and operation shall be imposed jointly with a fine of not less than RMB 2,000 yuan but not more than RMB 50,000 yuan; where circumstances are serious, license revocation shall be enforced by the original issuing body.

Article 92 With respect to food production and operation enterprises whose food production or distribution or catering service licenses are revoked, the officers directly responsible for such enterprises shall be prohibited from managing food production and operation for five years from the date of the sanction decision.

Where food producers and business operators employ persons who are prohibited from engaging in management of food production and operation for such purpose, the original license issuing bodies shall revoke the licenses of such producers and business operators.

Article 93 Where food product inspection bodies or inspectors, in violation of this Law, issue false inspection reports, the competent departments or authorities which qualify them shall revoke the inspection qualifications of such bodies; the persons directly in charge and the food inspector concerned shall be given a sanction of removal from office or dismissal according to the law.

Personnel of food product inspection bodies convicted of criminal charges or dismissed as a result of violations of this Law shall be prohibited from engaging in food product inspection operations for ten years from the date the relevant criminal penalties are completely served or sanction decisions are made. Where food product inspection bodies employ persons who are prohibited from engaging in food inspection operation for such purpose, the competent departments or authorities by which they were qualified shall revoke their qualification.

Article 94 Entities or individuals misleading consumers with regard to the quality of certain food products through false advertisements in violation of this Law shall be punished in accordance with relevant provisions set out in the Advertisement Law of the People's Republic of China.

Where food safety supervisory and regulatory authorities, organizations responsible for food safety inspection operations, food product associations and consumer associations recommend certain food products to the public through advertisements or otherwise in violation of this Law, illegal income involved shall be confiscated by the competent departments in charge, and the persons directly in charge and the other persons directly responsible for such cases shall be subject to punishments of major demerit, demotion, removal from office or dismissal according to the law.

Article 95 In the case of major food safety accidents with serious public consequences resulting from failure to fulfill obligations in food safety supervision and administration by the local people's governments at or above the county level, the persons directly in charge and the other persons directly responsible for such accidents shall be subject to punishment of major demerit, demotion, removal from office or dismissal according to the law.

In the case of administrative department of health, the agricultural administrative department, the department of quality supervision, the administration for industry and commerce, or the food and drug administration at or above the county level failing to fulfill relevant obligations specified in this Law, or found guilty of abuse of power, dereliction of duty, engaging in malpractices for personal gain, the persons directly in charge or the other persons directly responsible shall be subject to punishment of major demerit or demotion according to the law; for cases which have resulted in severe consequences, such persons shall be removed from office or dismissed; and the leading person who is in charge shall resign as an admission of guilt.

Article 96 In the case of violations of this Law causing human injuries, property losses or other losses, the offender concerned shall be held liable for compensation according to the law.

As regards the production of food products which fail to meet the food safety standards and the deliberate selling of such food products, consumers affected may demand reparation worth ten times the price of said food product, in addition to compensation for losses arising therefrom.

Article 97 Civil damages shall be given priority in the event that violators of this Law do not have enough property to pay civil damages and fines or penalties in full.

Article 98 In case of violations of this Law involving criminal offenses, the offenders shall be prosecuted in accordance with the law.

 

Chapter X

Supplementary Provisions

Article 99 For the purpose of this Law, these terms are defined as follows: "Food products" refers to finished products which are edible or drinkable by humans, ingredients used to produce them, and substances which have been traditionally used both as food and medicinal materials, excluding substances used for therapeutic purposes.

"Food safety" refers to the requirement that food products shall be harmless and toxicant-free, meet reasonable nutritional requirements, and do not have any acute, sub-acute or chronic harmful effect on the human body.

"Pre-packaged food products" refers to food products which are measured and packaged in advance or produced inside packaging materials or containers.

"Food additives" refers to artificial or natural substances added to food products to improve their quality, color, flavor or taste, or due to preservation or the technical considerations in food processing.

"Packaging materials and containers used for food products" refer to paper, bamboo, wood, metal, enamel, porcelain, plastic, rubber, natural or chemical fiber, glass, etc. materials used to package or contain food products or food additives, and coating materials or paints which are in direct contact with food products or food additives.

"Tools and equipment used for food production and operations" refer to machines, pipes, conveyer belts, containers, tools, serving utensils, etc. which are in direct contact with food products or food additives, during the production, transportation or usage of food products or food additives.

"Detergents and disinfectants used for food products" refer to substances used to wash or disinfect food products, serving utensils, tools and equipment with which food products are in direct contact, and food packaging materials or containers.

"Shelf life" refers to the length of time a pre-packaged food product can be stored under the storage conditions specified on the label before it becomes too old to be sold or used.

"Food-borne diseases" refer to infectious and toxic diseases caused by pathogenic factors contained in food products which enter into human body.

"Food poisoning" refers to acute or sub-acute diseases caught by eating contaminated food products or food products which contain toxic or harmful substances.

"Food safety accidents" refer to food-related accidents, e.g. food poisoning, food-borne diseases and food contamination, etc. which are harmful, or potentially harmful, to human health.

Article 100 Licenses issued to food producers and business operators prior to the enforcement of this Law shall remain effective.

Article 101 This Law is applicable to administration of food safety for dairy products, genetically altered food products, slaughtered pigs, alcohol, and salt products, unless otherwise stipulated by other laws or administrative regulations, in which case the latter shall prevail.

Article 102 Food safety measures for food products being transported by rail shall be formulated by the administration department of health under the State Council jointly with other relevant departments under the State Council in accordance with this Law.

Food safety measures for military food products and self-supplied food products shall be formulated by the Central Military Commission in accordance with this Law.

Article 103 The State Council may decide to revise the food safety supervision and regulation system on the basis of practical needs. Article 104 This Law shall go into effect as of June 1, 2009. The Food Hygiene Law of the People's Republic of China shall be repealed simultaneously.