Regulation on the implementation of the Food Safety Law of the People’s Republic of China

Regulation on the Implementation of the Food Safety Law of the People’s Republic of China Promulgation date: 07-20-2009 Department: State Council Effective date: 07-20-2009 Subject: Health and Sanitation Order of the State Council of the People’s Republic of China (No. 557) The Regulation on the Implementation of the Food Safety Law of the People’s Republic of China, which was adopted at the 73rd executive meeting of the State Council on July 8, 2009, is hereby promulgated and shall come into force on the date of promulgation. Premier Wen Jiabao July 20, 2009 Regulation on the Implementation of the Food Safety Law of the People’s Republic of China Chapter I General Provisions Article 1 This Regulation is formulated in accordance with the Food Safety Law of the People’s Republic of China (hereinafter referred to as the “Food Safety Law”). Article 2 The people’s governments at and above the county level shall perform their duties as prescribed in the Food Safety Law; build up their capabilities of food safety supervision and administration, and provide safeguards for the work of food safety supervision and administration; shall establish and improve a coordination and cooperation mechanism for food safety supervision and administration departments, integrate and improve food safety information networks, and realize the sharing of food safety information and sharing of technical resources in such aspects as food inspection. Article 3 The food producers and business operators shall, in accordance with laws, regulations and food safety standards, engage in production and business operation, establish and improve the food safety management system, and take effective management measures to ensure food safety. The food producers and business operators shall be responsible for the safety of food which they produce and deal in, be responsible to the society and the general public, and bear the social responsibilities. Article 4 The food safety supervision and administration departments shall, in accordance with the provisions of the Food Safety Law and this Regulation, release the food safety information, and provide conveniences for public consultation, complaints and tip-offs. Any organization or individual shall be entitled to obtain the food safety information from the relevant departments. Chapter II Monitoring and Assessment of Food Safety Risks Article 5 The national food safety risk monitoring plan as prescribed in Article 11 of the Food Safety Law shall be formulated by the health administrative department of the State Council, jointly with the quality supervision department, industry and commerce administrative department, state food and drug administrative department, department of commerce, department of industry and information technology and other departments of the State Council according to the needs of such work as assessment of food safety risks, formulation and revision of food safety standards and food safety supervision and administration. Article 6 The health administrative departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government shall organize the quality supervision departments, industry and commerce administrative departments, food and drug supervision and administration departments, departments of commerce, departments of industry and information technology and other departments at the same level to formulate the food safety risk monitoring programs for their respective administrative regions in accordance with Article 11 of the Food Safety Law and file such programs with the health administrative department of the State Council. The health administrative department of the State Council shall notify the quality supervision department, industry and commerce administrative department, state food and drug administrative department, department of commerce, department of industry and information technology and other departments of the State Council about the filing. Article 7 In addition to making adjustments to the national food safety risk monitoring plan jointly with the relevant departments in accordance with Article 12 of the Food Safety Law, the health administrative department of the State Council shall, when necessary, adjust the national food safety risk monitoring plan according to the relevant disease information reported by the medical institutions. After the national food safety risk monitoring plan is adjusted, the health administrative departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government shall, in light of the specific situation within their respective administrative regions, make corresponding adjustments to the food safety risk monitoring programs of their respective administrative regions. Article 8 Where a medical institution finds that any patient received is a patient with food-borne disease, a food-poisoning patient, a patient with suspected food-borne disease or a suspected food poisoning patient, it shall promptly report the relevant disease information to the health administrative department at the county level of the place where it is located. The health administrative department receiving the report shall summarize and analyze the relevant disease information, timely report to the people’s government at the same level, and at the same time, report to the health administrative department at the next higher level; when necessary, it may directly report to the health administrative department of the State Council, and at the same time, report to the people’s government at the same level and the health administrative department at the next higher level. Article 9 The monitoring of food safety risks shall be assumed by the technical institutions determined by the health administrative departments of the people’s governments at or above the provincial level jointly with the quality supervision departments, industry and commerce administrative departments, food and drug supervision and administration departments and other departments at the same level. The technical institution undertaking the monitoring of food safety risks shall, under the food safety risk monitoring plan and program, carry out the monitoring work, ensure that the monitoring data are true and accurate, and according to the requirements of the food safety risk monitoring plan and program, report the monitoring data and analysis results to the health administrative department of the people’s government at or above the provincial level and the department assigning the monitoring task. The staff members for food safety risk monitoring may, when taking samples or collecting relevant data, enter the relevant planting and breeding places of edible agricultural products, places of food production, places of food circulation or places of catering services. Fees shall be paid as per the market price for the samples taken. Article 10 Where the analysis results of food safety risk monitoring show that there may be any hidden food safety risk, the health administrative department of the people’s government of a province, autonomous region or municipality directly under the Central Government shall timely notify the people’s governments at the districted city level and at the county level within its administrative region and the health administrative departments thereof about the relevant information. Article 11 The health administrative department of the State Council shall gather and summarize the monitoring data and analysis results of food safety risks, and notify the quality supervision department, industry and commerce administrative department, state food and drug administrative department, department of commerce, department of industry and information technology and other departments of the State Council about such data and results. Article 12 Under any of the following circumstances, the health administrative department of the State Council shall organize the assessment of food safety risks: (1) A risk assessment is needed for providing a scientific basis for formulating or revising the national food safety standards; (2) A risk assessment is needed for determining key fields and key varieties under supervision and administration; (3) Any new factor that may harm the food safety is found; (4) There is a need to determine whether a certain factor constitutes a hidden food safety risk; or (5) Any other circumstance under which the health administrative department of the State Council considers that a risk assessment is needed. Article 13 When the agriculture administrative department, quality supervision department, industry and commerce administrative department, state food and drug administrative department and other relevant department of the State Council offer suggestions for food safety risk assessment to the health administrative department of the State Council in accordance with Article 15 of the Food Safety Law, they shall provide the following information and materials: (1) The sources and natures of the risks; (2) The relevant inspection data and conclusions; (3) The extents of involvement with the risks; and (4) Other relevant information and materials. The local agriculture administrative departments, quality supervision departments, industry and commerce administrative departments, food and drug supervision and administration departments and other relevant departments at and above the county level shall assist in gathering the food safety risk assessment information and materials as prescribed in the preceding paragraph. Article 14 The health administrative departments and the agriculture administrative departments of the people’s governments at and above the provincial level shall timely notify each other of the relevant information on the monitoring of food safety risks and monitoring of quality and safety risks of edible agricultural products. The health administrative department and the agriculture administrative department of the State Council shall timely notify each other of the assessment results of food safety risks, assessment results of quality and safety risks of edible agricultural products and other relevant information. Chapter III Food Safety Standards Article 15 The health administrative department of the State Council shall, jointly with the agriculture administrative department, quality supervision department, industry and commerce administrative department, state food and drug administrative department, department of commerce, department of industry and information technology and other departments of the State Council, make the planning of national food safety standards and the implementation plan thereof. The planning of national food safety standards and the implementation plan thereof shall be made with the public opinions being solicited. Article 16 The health administrative department of the State Council shall select the entities with corresponding technical capabilities to draft the national food safety standards. The state shall encourage the research institutions, educational institutions, academic groups, industry associations and other entities to jointly draft the national food safety standards. The health administrative department of the State Council shall release the draft national food safety standards to the public and solicit the public opinions on the standards. Article 17 The health administrative department of the State Council shall be responsible for organizing the National Food Safety Standard Review Committee as prescribed in Article 23 of the Food Safety Law. The National Food Safety Standard Review Committee shall be responsible for examining the scientificity, practicability and other aspects of the draft national food safety standards. Article 18 The health administrative departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government shall notify the agriculture administrative departments, quality supervision departments, industry and commerce administrative departments, food and drug supervision and administration departments, departments of commerce, departments of industry and information technology and other departments at the same level about the enterprise standards filed by the enterprises under Article 25 of the Food Safety Law. Article 19 The health administrative department of the State Council and the health administrative departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government shall, jointly with the agriculture administrative departments, quality supervision departments, industry and commerce administrative departments, food and drug supervision and administration departments, departments of commerce, departments of industry and information technology and other departments at the same level, carry out follow-up evaluations of the implementation of the national food safety standards and the local food safety standards respectively, and on the basis of the evaluation results, organize the revision of the food safety standards in good time. The agriculture administrative departments, quality supervision departments, industry and commerce administrative departments, food and drug supervision and administration departments, departments of commerce, departments of industry and information technology and other departments of the State Council and the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government shall gather and summarize the problems existing in the implementation of the food safety standards, and timely notify the health administrative departments at the same level of such problems. Food producers and business operators and the food industry associations shall immediately report to the food safety supervision and administration departments the problems found in the implementation of the food safety standards. Chapter IV Food Production and Business Operation Article 20 To establish a food production enterprise, the name of the enterprise shall be subject to pre-approval, and the industrial and commercial registration shall be handled after a food production permit is obtained under the Food Safety Law. The quality supervision and administration department at or above the county level shall, in accordance with the relevant laws and administrative regulations, examine the relevant materials, check the production place, and inspect the relevant products; if the relevant materials and places meet the requirements of the relevant provisions and the relevant products meet the food safety standards or requirements, it shall decide to grant the permit. Other food producers and business operators shall, after legally obtaining the corresponding permits for food production, food circulation or catering services, handle the industrial and commercial registration. If a law or administrative regulation provides otherwise for the small food production or processing workshops or food vendors, such provisions shall prevail. The permit for food production, food circulation or catering services shall be valid for three years. Article 21 Where the conditions for production or business operation of a food producer or business operator change and the requirements for food production or business operation are no longer met, the food producer or business operator shall immediately take measures for rectification; if there is any potential risk of food safety accident, it shall immediately stop the food production or business operation, and report to the quality supervision department, industry and commerce administrative department or food and drug supervision and administration department at the county level of the place where it is located; if it is required to handle the permit formalities anew, it shall handle such formalities in accordance with law. The quality supervision department, industry and commerce administrative department or food and drug supervision and administration department at or above the county level shall strengthen the daily supervision and inspection on the production and business operation activities of the food producers or business operators; if it finds any incompliance with the requirements for food production and business operation, it shall order the food producer or business operator to make a correction immediately, and impose punishment in accordance with law; if the conditions for a permit for production or business operation are no longer met, it shall revoke the relevant permit in accordance with law. Article 22 An enterprise engaging in the food production or business operation shall, in accordance with Article 32 of the Food Safety Law, organize employees to attend the training on knowledge of food safety to study laws, regulations, rules and standards on food safety as well as other food safety knowledge, and establish training files. Article 23 A food producer or business operator shall, in accordance with Article 34 of the Food Safety Law, establish and implement a personnel health examination system and a personnel health record system. Where a person engaging in any work involving contact with ready-to-eat food suffers from dysentery, typhoid, viral hepatitis A, viral hepatitis E or any other infectious digestive tract disease, or from active tuberculosis, suppurative or exudative skin disease or any other disease that may affect the food safety, the food producer or business operator shall transfer him to another post without affecting the food safety. When, in accordance with paragraph 2 of Article 34 of the Food Safety Law, a person engaging in the food production or business operation receives a health examination, the examination items and other matters shall conform to the provisions of the province, autonomous region or municipality directly under the Central Government where he is located. Article 24 An enterprise engaging in the food production and business operation shall, in accordance with paragraph 2 of Article 36, paragraph 1 of Article 37 and paragraph 2 of Article 39 of the Food Safety Law, establish a checking record system for the purchased goods and an ex-factory food inspection record system to truthfully record the matters which are required to be recorded by law, or keep the bills for purchase or sale of goods bearing the relevant information. The records or bills shall be kept for at least two years. Article 25 As for a food production group enterprise which purchases raw materials in a centralized and uniform manner, the headquarters of the enterprise may uniformly check a supplier’s license and product inspection certificate, and make a checking record of the purchased goods; it shall, under the food safety standards, inspect the food raw materials for which the supplier is unable to provide an inspection certificate. Article 26 A food production enterprise shall establish and implement the food safety management systems for the check and acceptance of raw materials, production process safety, storage, equipment, substandard products, etc., and constantly improve the food safety safeguard system to ensure the food safety. Article 27 A food production enterprise shall formulate and implement control requirements with respect to the following matters to ensure that the ex-factory food meets the food safety standards: (1) Raw materials control over purchasing raw materials, checking and accepting raw materials, putting raw materials into production, etc.; (2) Control over the key components of production such as production process, equipment, storage and packaging; (3) Inspection control over the inspection of raw materials, semi-finished product inspection, ex factory inspection of finished products, etc.; and (4) Control over transport and delivery. If, in the food production process, there is any incompliance with the control requirements, the food production enterprise shall immediately find out the reasons and take measures for rectification. Article 28 A food production enterprise shall, in addition to make a checking record of the purchased goods and an ex-factory food checking record in accordance with Articles 36 and 37 of the Food Safety Law, truthfully record information on the safety management in the process of food production. The said record shall be kept for at least two years. Article 29 An enterprise engaging in the food wholesale business shall, when selling food, faithfully record the name, specifications, quantity, production batch number and shelf-life of the food, name and contact methods of purchasers, date of sale, etc., or keep the bills of sale bearing the relevant information. The record and bills shall be kept for at least two years. Article 30 The state shall encourage the food producers and business operators to record, by advanced technological means, the matters which are required to be recorded by the Food Safety Law and this Regulation. Article 31 A catering service provider shall formulate and implement the control requirements for the purchase of raw materials to ensure that the purchased raw materials meet the food safety standards. A catering service provider shall, during the production and processing process, check the food and raw materials to be processed, and shall not process or use any food or raw material which is found to be rotten or deteriorative or abnormal in sensory properties. Article 32 An enterprise providing catering service shall maintain its facilities and equipment for processing, storage, display, etc. of food on a regular basis; and clean and check out its heat preservation facilities and cooling and refrigeration facilities on a regular basis. A catering service provider shall, in accordance with the relevant requirements, clean and disinfect the cutlery and drinking sets, and shall not use those that are not cleaned and disinfected. Article 33 The food producer shall make innocuous disposal of or destroy the food recalled in accordance with Article 53 of the Food Safety Law so as to prevent such food from re-entering the market. The food producer may continue to sell the food recalled for the food labels, marks or instructions fail to meet the food safety standards, provided that it takes remedial measures and is able to ensure the food safety; and when selling such food, it shall expressly indicate the remedial measures to the consumers. The quality supervision departments, industry and commerce administrative departments, and food and drug supervision and administration departments at and above the county level shall enter the information on the food producers’ recalls of food failing to meet the food safety standards and the food business operators’ cessation of business operations on food failing to meet the food safety standards into the food safety credit files for food producers and business operators. Chapter V Food Inspection Article 34 When applying for re-inspection to the food inspection institution undertaking the re inspection work (hereinafter referred to as the “re-inspection institution”) in accordance with paragraph 3 of Article 60 of the Food Safety Law, an applicant shall give reasons. The directory of re-inspection institutions shall be jointly published by the certification and accreditation administrative department, the health administrative department, the agriculture administrative department and other departments of the State Council. The re-inspection conclusion issued by a re-inspection institution shall be the final inspection conclusion. The re-inspection institution shall be at the option of the applicant. The re-inspection institution and the initial inspection institution shall not be the same. Article 35 Where a food producer or business operator raises any objection to the conclusion of a sampling inspection conducted under Article 60 of the Food Safety Law and applies for re inspection, if the re-inspection conclusion shows that the food is up to the standard, the expenses for the re-inspection shall be borne by the department conducting the sampling inspection; if the re inspection conclusion shows that the food is not up to the standard, the expenses for the re inspection shall be borne by the food producer or business operator. Chapter VI Import and Export of Food Article 36 A food importer shall apply for inspection to the entry-exit inspection and quarantine institution at the place of customs declaration on the basis of the contract, invoice, packing list, bill of lading and other necessary vouchers and relevant approval documents. The imported food shall pass the inspection of the entry-exit inspection and quarantine institution. The customs office shall release the imported food on the basis of the clearance certificate issued by the entry-exit inspection and quarantine institution. Article 37 For the import of food which is not covered by the national food safety standards or for the initial import of a new variety of food additive or a new variety of food-related product, the importer shall submit the licensing certificate obtained under Article 63 of the Food Safety Law to the entry-exit inspection and quarantine institution, and the entry-exit inspection and quarantine institution shall conduct inspection according to the requirements of the health administrative department of the State Council. Article 38 Where, in the imported food, the entry-exit inspection and quarantine department of the state finds any substance which is not covered by the national food safety standards and may be harmful to the human health, it shall notify the health administrative department of the State Council in accordance with Article 12 of the Food Safety Law. Article 39 An overseas food production enterprise exporting food to China shall go through the registration formalities in accordance with Article 65 of the Food Safety Law, and the registration shall be valid for four years. Where a registered overseas food production enterprise provides any false material, or a major food safety accident occurs to the relevant imported food for reasons of the overseas food production enterprise, the entry-exit inspection and quarantine department of the state shall revoke the registration and make an announcement. Article 40 The imported food additives shall have labels and instructions in Chinese. The labels and instructions shall conform to the provisions of the Food Safety Law and other relevant laws and administrative regulations and the requirements of the national food safety standards of China, and state the place of origin of the food additives as well as the name, address and contact method of the agent within China. No food additive may be imported if it does not have labels and instructions in Chinese or the labels and instructions do not conform to the provision hereof. Article 41 The entry-exit inspection and quarantine institutions shall conduct inspections on imported food in accordance with Article 62 of the Food Safety Law and conduct supervision and sampling inspection on the food to be exported in accordance with Article 68 of the Food Safety Law. The specific measures shall be formulated by the entry-exit inspection and quarantine department of the state. Article 42 The entry-exit inspection and quarantine department of the state shall establish an information gathering network, and in accordance with Article 69 of the Food Safety Law, gather, summarize and make notification of the following information: (1) The food safety information found by the entry-exit inspection and quarantine institutions during their inspection and quarantine of the imported and exported food; (2) The imported food safety information reported by the industry associations and consumers; (3) The food safety information and risk warning information released by the international organizations and overseas governmental institutions and the food safety information reported by the overseas industry associations and other organizations as well as consumers; and (4) Other food safety information. The notified departments shall, when necessary, take the corresponding handling measures. The food safety supervision and administration departments shall timely notify the entry-exit inspection and quarantine department of the state of the information involving the imported and exported food safety which they acquire. Chapter VII Handling of Food Safety Accidents Article 43 An entity in which a food safety accident occurs shall immediately take such control measures as sealing up for the food, raw materials, utensils, equipment, etc. that cause or may cause the food safety accident, and report to the health administrative department of the people’s government at the county level of the place where it is located within two hours from the occurrence of the accident. Article 44 The principles of seeking truth and respecting science shall be followed during the investigation of a food safety accident, and the investigative departments shall timely and accurately find out the nature and causes of the accident, determine the liabilities for the accident and put forward measures for rectification. The departments participating in the investigation of a food safety accident shall, under the centralized organization and coordination of the health administrative departments, cooperate with each other on the basis of their respective functions, and enhance the work efficiency of the investigation and handling of the accident. The measures for the investigation and handling of food safety accidents shall be formulated by the health administrative department of the State Council jointly with the relevant departments of the State Council. Article 45 The departments participating in the investigation of a food safety accident shall have the authority to inquire of the relevant entities and individuals about the accident and require them to provide the relevant materials and samples. The relevant entities and individuals shall cooperate in the investigation and handling of a food safety accident and provide the relevant materials and samples as required, and shall not reject the requirement. Article 46 No entity or individual shall obstruct or interferer with the investigation and handling of a food safety accident. Chapter VIII Supervision and Administration Article 47 An annual plan on the food safety supervision and administration drawn by the people’s government at or above the county level in accordance with Article 76 of the Food Safety Law shall cover the sampling inspection of food. The sampling inspection shall be specifically reinforced as for the staple and supplementary food exclusively for infants, the elderly, patients and other particular groups of people. The agriculture administrative departments, quality supervision departments, industry and commerce administrative departments and food and drug supervision and administration departments at and above the county level shall, in accordance with the annual plans on the food safety supervision and administration, carry out sampling inspections. The expenses needed for the purchase of samples, inspection fees, etc. for the sampling inspection shall be paid out of the public finance at the same level. Article 48 The people’s government at the county level shall, by uniformly organizing and coordinating the health administrative department, agriculture administrative department, quality supervision department, industry and commerce administrative department and food and drug supervision and administration department at the same level, carry out the supervision and administration of the food producers and business operators within its administrative region; and specifically reinforce the supervision and administration of the food producers and business operators with a higher risk of food safety accidents. After the health administrative department of the State Council releases any food safety risk warning information or after receiving the food safety risk monitoring information in a notification made by the health administrative department of the province, autonomous region or municipality directly under the Central Government of the place where it is located in accordance with Article 10 of this Regulation, the people’s government at the districted city or county shall promptly organize the health administrative department, agriculture administrative department, quality supervision department, industry and commerce administrative department and food and drug supervision and administration department at the same level to take pertinent measures to prevent the occurrences of food safety accidents. Article 49 The health administrative department of the State Council shall, based on the disease information, supervision and administration information, etc., publish a catalogue of the nonfood chemical substances and other substances harmful to the human health found to be added or likely added to food and the testing method thereof; the quality supervision department, industry and commerce administrative department and state food and drug administrative department of the state council shall take the corresponding supervision and administration measures. Article 50 The quality supervision departments, industry and commerce administrative departments and food and drug supervision and administration departments may, in the food safety supervision and administration, conduct preliminary screening of food by adopting the rapid testing methods determined by the quality supervision department, industry and commerce administrative department and state food and drug administrative department of the State Council; and shall, in accordance with paragraph 3 of Article 60 of the Food Safety Law, conduct inspections of food that may fail to meet the food safety standards according to the preliminary screening results. The preliminary screening results shall not serve as a basis for law enforcement. Article 51 The routine supervision and administration information on food safety as prescribed in paragraph 2 of Article 82 of the Food Safety Law shall cover: (1) Information on the implementation of administrative licensing under the Food Safety Law; (2) The catalogues of food, food additives and food-related products of which the production and business operation have been ordered to stop; (3) Information on the investigation and punishment of food production and business operation activities in violation of law; (4) Information on special campaigns on inspection and rectification; and (5) Other routine supervision and administration information on food safety as prescribed by laws and administrative regulations. Where the information as prescribed in the preceding paragraph involves the functions of two or more food safety supervision and administration departments, such information shall be released jointly by the relevant departments. Article 52 The food safety supervision and administration departments shall, when releasing information in accordance with Article 82 of the Food Safety Law, make explanations and statements about the possible harms caused by the relevant food. Article 53 The health administrative departments, agriculture administrative departments, quality supervision departments, industry and commerce administrative departments, food and drug supervision and administration departments and other departments shall publish their e-mail addresses or telephone numbers to receive consultation requests, complaints or tip-offs; and in accordance with Article 80 of the Food Safety Law, make replies to, verify and handle the consultation requests, complaints or tip-offs received, and maintain a record of information on such consultation requests, complaints and tip-offs as well as replies, verifications and handling. Article 54 The department of industry and information technology, department of commerce and other departments of the State Council shall, according to their respective functions, make the development planning and industrial policies for the food industry, take measures to boost the optimization of the industrial structure, strengthen the guidance of the development of the food industry credit system, and promote the sound development of the food industry. Chapter IX Legal Liability Article 55 Where, after the conditions for production or business operation change, a food producer or business operator fails to handle it in accordance with Article 21 of this Regulation, the relevant competent department shall order it to make a correction and give it a warning; if any serious result is caused, it shall be punished in accordance with Article 85 of the Food Safety Law. Article 56 Where a catering service provider fails to formulate and implement the control requirements for the purchase of raw materials in accordance with paragraph 1 of Article 31 of this Regulation, it shall be punished in accordance with Article 86 of the Food Safety Law. Where a catering service provider fails to check the food or raw materials to be processed in accordance with paragraph 2 Article 31 of this Regulation, or after finding any food or raw material to be rotten or deteriorative or abnormal in sensory properties, still processes or uses such food or raw material, it shall be punished in accordance with Article 85 of the Food Safety Law. Article 57 Under any of the following circumstances, the punishment shall be imposed in accordance with Article 87 of the Food Safety Law: (1) A food production enterprise fails to establish or implement the food safety management system in accordance with Article 26 of this Regulation; (2) A food production enterprise fails to formulate or implement the production process control requirements in accordance with Article 27 of this Regulation, or during the food production, fails to take measures for rectification as required in the case of any incompliance with the control requirements; (3) A food production enterprise fails to record the safety management information in the process of food production or keep the relevant record in accordance with Article 28 of this Regulation; (4) An enterprise engaging in the food wholesale business fails to record or keep the sales information or keep the bills of sale in accordance with Article 29 of this Regulation; (5) An enterprise providing catering service fails to maintain, clean or check out the facilities and equipment on a regular basis in accordance paragraph 1 of Article 32 of this Regulation; or (6) A catering service provider fails to clean or disinfect the cutlery or drinking sets in accordance with paragraph 2 of Article 32 of this Regulation or uses the cutlery or drinking sets that are not cleaned or disinfected. Article 58 Where any food additives that does not conform to Article 40 of this Regulation are imported, the entry-exit inspection and quarantine institution shall confiscate the illegally imported food additives; and impose a fine of not less than 2, 000 yuan but not more than 50, 000 yuan on the violator if the goods value of the illegally imported food additives is less than 10, 000 yuan or impose a fine of not less than 2 times but not more than 5 times the goods value if the goods value of the said food additives is 10, 000 yuan or more. Article 59 Where a medical institution fails to report the relevant disease information in accordance with Article 8 of this Regulation, the health administrative department shall order it to make a correction and give it a warning. Article 60 Where an entity in which a food safety accident occurs fails to take measures and report in accordance with Article 43 of this Regulation, it shall be punished in accordance with Article 88 of the Food Safety Law. Article 61 Where the people’s government at or above the county level fails to perform its statutory duties of food safety supervision and administration, and a major food safety accident occurs in its administrative region, which has a serious social impact, the directly responsible person in charge and other directly liable persons shall be subject to a sanction of major demerit, demotion, removal or dismissal according to law. Where the health administrative department, agriculture administrative department, quality supervision department, industry and commerce administrative department, food and drug supervision and administration department or any other relevant administrative department at or above the county level fails to perform its statutory duties of food safety supervision and administration, fails to conduct adequate routine supervision and inspection, or abuses its powers, neglects its duties or practices favoritism, the directly responsible person in charge and other directly liable persons shall be subject to a sanction of major demerit or demotion according to law; and if any serious result is caused, they shall be subject to a sanction of removal or dismissal, and the chief person in charge shall take the blame and resign. Chapter X Supplementary Provisions Article 62 The following terms as used in this Regulation shall have the following meanings: The term “assessment of food safety risks” refers to the scientific assessment of the adverse effects that may be caused to the human health by the biological, chemical and physical hazards in food or food additives, including hazard identification, hazard characterization, exposure assessment, risk characterization, etc. The term “catering service” refers to the service activities of providing food and consumption places and facilities to consumers through spot production and processing, commercial sales, service work, etc. Article 63 The monitoring and assessment of quality and safety risks of edible agricultural products shall be carried out by the agriculture administrative departments of the people’s governments at and above the county level in accordance with the Law of the People’s Republic of China on Agricultural Product Quality and Safety. The supervision and administration of food at frontier ports shall be carried out by the entry-exit inspection and quarantine institutions in accordance with the Food Safety Law, this Regulation and the provisions of the relevant laws and administrative regulations. The food and drug supervision and administration departments shall carry out stringent supervision and administration of food allegedly having certain health protection effects, and the specific measures shall be separately formulated by the State Council. Article 64 This Regulation shall come into force on the date of promulgation.