国家食品药品监督管理总局业务主管
中华人民共和国食品安全法实施条例(修订草案送审稿)(英文版)
发布日期:2016-10-28
 Implementation Rules of Food Safety Law of the People’s Republic of China

(Revised Draft for Official Review)

 

Chapter 1 General Provisions

Article 1 The Implementation Rules of Food Safety Law of the People’s Republic of China (hereinafter referred to as “the Rules”) are promulgated in accordance with the Food Safety Law of the People’s Republic of China (hereinafter referred to as the “Food Safety Law”).

Article 2 Food producers and traders shall conduct production and trading activities according to laws, regulations and food safety standards, establish and improve food safety management system, take effective measures to prevent and control food safety risks, and guard against and reduce food safety hazards to ensure food safety.

Article 3 The food safety commission under the State Council shall be responsible for discussing & laying out and planning & directing the national food safety work, formulating national food safety strategies, putting forward major food safety policies and measures, analyzing and solving significant food safety problems and supervising & urging and inspecting the implementation of significant national decisions and arrangements relating to food safety.

The executive office of the food safety commission under the State Council shall undertake the daily work of the committee, organize the preparation of the national food safety plans, coordinate the addressing of significant problems found in the formulation and implementation of food safety laws, regulations and standards, evaluate and assess the fulfillment of food safety-related responsibilities by the People’s Governments at province level and the relevant departments under the State Council and direct the handling and information release of major food safety accidents.

Article 4 The local People’s Government at or above the county level shall bear the localized management responsibility for the food safety within its own administrative region, establish uniform and authoritative the food safety supervision and administration systems and mechanisms, strengthen the construction of food safety governance systems and governance abilities, guarantee the implementation of food safety regulation authorities, regulatory staff, funds and technical supports, etc. and shoulder, subject to law, the responsibility for regional food safety risks and major food safety accidents occurred

Food safety commission and its executive office under local People’s Government at or above the county level shall increase general planning, coordination, supervision and direction of food safety work within its own administrative region, and its responsibilities shall be determined by local People’s Governments at different levels with reference to the responsibilities of food safety commission and its executive office under the State Council.

Article 5 The People’s Government and sub-district office at township level shall be responsible for food safety management works such as troubleshooting hidden dangers to food safety, reporting information, assisting law enforcement and conducting propaganda & education within its own administrative region.

The People’s Government and sub-district office at township level shall support the resident agencies for supervision and administration of food and drug to carry out the supervision and administration works pursuant to the law.

The People’s Government and sub-district office at township level shall establish the teams such as food safety coordinators or informers, etc., to assist the food and drug administrative department to effectively perform food safety works.

Work expense of food safety coordinators or informers shall be included in the financial budget of the People’s Government at county level.

Article 6 The State has incorporated food safety knowledge into the curriculums of national quality-oriented education and primary and secondary school education, to strengthen the popularization of scientific elementary knowledge and legal knowledge associated with food safety and improve the food safety consciousness of the whole society.

News media shall implement food safety propaganda for public good in accordance with the regulations by the competent authority and the food and drug department.

Article 7 The People’s Government at or above the county level shall formulate food safety reward and punishment management method, establish projects and funds for food safety awards to grant commendations and rewards to those entities and individuals that have made conspicuous achievements in the works such as food safety risk monitoring and assessment, standard formulation and implementation, supervision and inspection, security ensuring of important activities, emergency handling, case investigation and treatment, evaluation and assessment as well as scientific research, propaganda & education and social co-governance, etc.

 

Chapter 2 Food Safety Risk Monitoring and Assessment

Article 8 The health administrative department under the State Council shall, in conjunction with food and drug administrative, quality supervisory and agriculture administrative departments, etc., under the State Council, prepare and publish the national food safety risk monitoring plan.

The health administrative departments of provinces, autonomous regions and municipalities of the People’s Government shall report the local food safety risk monitoring plan to the health administrative department under the State Council for record-filing. The health administrative department under the State Council shall notify food and drug administrative, quality supervisory and agriculture administrative departments, etc., under the State Council, of the information on record-filing.

Article 9 The health administrative department under the State Council shall be responsible for organizing and carrying out the risk-based monitoring of foodborne diseases, food contamination and harmful factors in foods.

The food and drug administrative department under the State Council shall be responsible for organizing and carrying out the risk-based monitoring of harmful factors in food production and sales, catering services and other links.

The quality supervisory department under the State Council shall be responsible for organizing and carrying out the risk-based monitoring of harmful factors in food-related products and imported and exported foods.

The agriculture administrative department is responsible for organizing and implementing risk monitoring towards pesticide and veterinary drug residues as well as other contaminants and harmful factors in edible agricultural products before production and processing and before entry into wholesale and retail markets.

Relevant departments shall organize the consultation of the problems found in the food risk monitoring respectively undertaken by them and take effective measures to prevent and control food safety risks.

Article 10 The national food safety risk monitoring scheme and plan shall take the foods without available food safety standards currently and their related harmful factors as key monitored objects:

1) Those with high level of risks, wide sphere of circulation and large amount of consumption;

2) Those liable to affect the health of infants and young children and other specific populations;

3) Those with many food safety problems reflected or complained by consumers;

4) Those having caused food safety accidents at abroad.

Article 11 The health administrative, food and drug administrative, quality supervisory and agriculture administrative departments, etc., shall make full use of the technical institutions with corresponding qualifications, including social third-party technical institutions, to conduct the food safety risk monitoring work.

The technical institutions undertaking the food safety risk monitoring work shall conduct the work according to the food safety risk monitoring plan, monitoring program and work specifications, to ensure the trueness, accuracy and completeness of the monitoring data, and shall not publish or use for commercial purpose the data and relevant materials of food safety risk monitoring if without authorization.

Article 12 The health administrative department under the People’s Government at province level shall, in conjunction with food and drug administrative, quality supervisory and agriculture administrative departments etc., at the same level, establish the notification mechanisms of national food safety risk monitoring, summarize and analyze the risk monitoring data, study and judge food safety risks, form the monthly, quarterly, half-year and annual analysis reports on food safety risk monitoring and report to the People’s Government at province level and health administrative department under the State Council within 7 working days after the report is produced, and also copy to food and drug administrative, quality regulatory and agriculture administrative departments, etc., at the same level. In case of finding the possible existence of high food safety risks, they shall be reported within 2 working days after the report is produced.

Article 13 In case that the health administrative departments find the possible existence of the food safety hidden dangers during the food safety risk monitoring work, they shall carry out food safety risk assessment in a timely manner and report the assessment results to the food and drug administrative department, etc.; in case of finding the existence of illegal activities involving food production and trading, they shall notify the food and drug administrative department, etc., in a timely manner.

In case of finding possibility of potential food safety risk during the food safety investigation work, food and drug administrative department, etc., shall notify the health administrative department in a timely manner to timely conduct food safety risk assessment and the health administrative department shall notify the assessment results to the food and drug administrative department, etc.

Article 14 In case that the results of food safety risk monitoring show the existence of food safety risks, the food and drug administrative department can inform relevant food producers and traders according to the needs of risk control.

Upon receipt of the such information, the food producers and traders shall immediately take measures to troubleshoot risks; and if potential food safety risk is identified, shall suspend the production, sales and use of products involved, recall the foods with food safety hidden dangers and report to the food and drug administrative department of the People’s Government at or above the county level where it is located in a timely manner.

Article 15 The committee of experts for national food safety risk assessment shall be set up and managed by the health administrative department under the State Council, in conjunction with food and drug administrative, quality supervisory and agriculture administrative departments, etc., under the State Council.

The committee of experts for national food safety risk assessment shall be responsible for formulating the technical methods and requirements for food safety risk assessment, examining and approving the report of the food safety risk assessment results and explaining and communicating food safety risk assessment results.

Article 16 The health administrative department under the State Council shall, in conjunction with food and drug administrative department, etc., under the State Council, prepare the food safety risk assessment work plan, establish and manage the basic database for national food safety risk assessment, and organize and carry out the works such as collection of basic data on food safety risk assessment and method study, etc.

The health administrative, food and drug administrative, quality supervisory and agriculture administrative departments, etc., under the State Council, shall establish an information exchange mechanism of food safety risk assessment and share risk assessment data and information.

Article 17 In case that health administrative, food and drug administrative and quality supervisory departments etc., under the State Council, find that the safety of pesticides, fertilizers, veterinary drugs, feeds and feed additives, etc., is required to be assessed during the supervision and administration work, they shall put forward the suggestion for risk assessment to the agriculture administrative department under the State Council, and the agriculture administrative department under the State Council shall timely conduct risk assessment and in a timely the assessment results to the relevant departments under the State Council.

The safety assessment of pesticides, fertilizers, veterinary drugs, feeds and feed additives, etc., shall be carried out by relevant review committee, in conjunction with committee of experts for national food safety risk assessment.

Article 18 The health administrative department under the State Council shall according to the needs of food safety risk assessment work, organize and carry out surveys to collect basic data such as status on food consumption, environmental factors affecting food safety, total dietary study and degree of public cognition, etc.

Article 19 The food and drug administrative department under the People’s Government at or above province level shall, in conjunction with relevant departments at the same level, conduct comprehensive analysis on food safety conditions according to the food safety assessment results and food safety monitoring and administrative information, and the food and drug administrative department under the People’s Government at or above province level shall timely issue and publish food safety risk warning information, as for foods considered to possibly carry high safety risks upon comprehensive analysis.

If food safety risk warning is limited to a specific region, relevant food and drug administrative departments at city and county levels within the region may publish food safety risk reminder according to the need.

Article 20 The State shall establish food safety risk communication system.

The food and drug administrative department under the State Council shall, in conjunction with other relevant departments, establish a food safety risk communication mechanism and encourage and support food producers and traders, food safety technical institutions, food-related industrial associations, scientific research institutes, food industry associations, consumers’ associations, lawyers’ associations and news media, etc., to participate in the food safety risk communication work.

Article 21 The food and drug administrative department under the State Council shall, in conjunction with other relevant departments, establish the advisory committee for food safety risk communication composed of experts from fields such as food, public health, clinical medicine, environment and ecosystem, quarantine and epidemic prevention, nutrition science, news communication and law, etc., to provide consulting advices for food safety risk communication.

 

Chapter 3 Food Safety Standard

Article 22 The health administrative department under the State Council shall, in conjunction with in conjunction with food and drug administrative, quality supervisory and agriculture administrative departments, etc., under the State Council, make and publish the planning of national food safety standards and the annual implementation plan.

Article 23 The health administrative department under the State Council shall, in conjunction with food and drug administrative department under the State Council, establish National Food Safety Standard evaluation Committee to formulate the measures for administration of national food safety standards and organize the project approval, draft, review and promulgation of national food safety standards.

The health administrative department under the State Council may, in conjunction with food and drug administrative department, select the institutions with corresponding technical capabilities to draft the national food safety standards.

It shall formulate the national food safety standards and publish the results of handling of opinions put forward by many.

It shall encourage the research institutions, technical institutions, academic groups, industrial associations and other entities to jointly draft the national food safety standards.

Article 24 The health administrative department under the State Council shall, in conjunction with food and drug administrative department, formulate national food safety standards concerning food additive on its variety, application scope and limits in catering services and national food safety standards urgently needed in food safety supervision and law enforcement.

Article 25 The health administrative departments of the People’s Governments of provinces, autonomous regions and municipalities shall, in conjunction with food and drug administrative department at the same level, make the planning of local food safety standards and the implementation plan thereof, and organize the project approval, draft, review and promulgation of local food safety standards.

Such local food safety standards concerning health food, formula food for special medical purpose, formula food for infants and young children, food additives, food-related products, new food raw materials and food safety-related food test approaches and specifications, etc., shall not be formulated.

Article 26 The health administrative departments of the People’s Governments of provinces, autonomous regions and municipalities shall, within 30 working days after publishing of local food safety standards, report to the health administrative departments under the State Council for record-filing.

Where the health administrative departments under the State Council find the violations of food safety standards and national laws & regulations, it shall be corrected without delay.

once a national food safety standard is published and implemented, the corresponding local food safety standard would be eliminated. The health administrative department of the People’s Governments of provinces, autonomous regions and municipalities shall timely publish its abolishment.

Article 27 Food production enterprises shall be responsible for their respective enterprise standards. Upon approval of enterprise legal representative or main person in charge, enterprise standards shall be implemented.

Enterprise standard on health food, formula food for special medical purpose or formula milk powder for infants and young children may not need enterprise standard record-filing if such standard is already included in technical specifications such as product formula production technics.

The health administrative department of the People’s Government at or above province level shall publish on its official website the field enterprise standard within 15 working days after record-filing of such enterprise standard for free inquiry and download by the public.

Food production enterprises shall publish their enterprise standards being implemented for inquiry and supervision by the public.

Article 28 The health administrative department under the State Council shall, in conjunction with the food and drug administrative, quality supervisory and agriculture administrative departments, etc., under the State Council, conduct timely tracking assessment and revision of the national food safety standards according to according to the results of food safety risk monitoring and supervision & sampling inspection.

 

Chapter 4 Food Production and Trading

Section 1 General Provisions

Article 29 Food and drug administrative department under the State Council shall, according to the economic and social development level, production and trading scale, technical conditions, food safety requirements and other factors, develop norms for food production and trading.

The food producers and traders shall, according to the norms for food production and trading, carry out production and trading activities.

Article 30 Any food producer and trader shall not, during production and trading process, purchase, use, store and transport such non-edible materials that are strictly forbidden by relevant authorities, and shall not process foods or food additives with the recalled food additives.

It is prohibited to add chemical substances not included in the national food safety standards and other substances that may endanger human health.

Article 31 Any enterprise specializing in food production, food sales and catering service shall obtain a food production license according to law. Such license is valid for five years.

Any producer producing, processing and selling externally pre-mixes and extracts of heath foods shall be under administration based on health food production license.

Article 32 Any food producer obtaining a food production license shall not be required to obtain a food trading license in the case of sales of their products in its own production sites or through the Internet; any operator obtaining a food trading license shall not be required to obtain a food production license in the case of sales of its self-made products in its own operation sites or through the Internet.

Article 33 The food producers and traders shall conduct production and trading activities within the scope of their respective food production licenses and food trading licenses, and shall not run beyond such scope.

Article 34 In the event that food producers and traders entrust the production of foods and food additives, the entrusted party shall obtain a food production license and be responsible for its production behaviors. The entrusting party shall undertake legal liabilities for the safety of foods that are entrusted for production.

For entrusted food and food additive production, both parties shall sign a written agreement, in which the respective rights and obligations concerning food safety of both sides are clearly defined.

Article 35 In the event of change of production or trading conditions of any food producer or trader and which results in the need of reapplication of license is needed, such producer or trader shall reapply and obtain the license according to law.

The food and drug administrative department at or above the county level shall enhance daily supervision and inspection on production and trading activities of food producers and traders, and shall order to make immediate correction and dispose according to law in case that such activities are found incompliant with food production and trading requirements.

Article 36 The health administrative department under the State Council shall regularly collect and publish the new food raw material, new varieties of food additives, catalogue of new varieties for food-related products as well as the executive national food safety standards, and carry out tracking evaluation of safety.

Article 37 The safety assessment materials concerning new food raw material, new varieties of food additives and food-related products that applicants submit to the health administrative department under the State Council shall include the essential supporting materials in technology of relevant industry organization, safety assessment opinion of specialized technical institutions as well as development of relevant standards and standard text, etc.

Article 38 Such substances listed in the catalogue of substance traditionally considered as both food and Chinese medicine shall also meet the following requirements:

1) Have edible history in our country, and have not found any acute, sub- acute, chronic and other potential danger to human health;

2) Have record of human consumption in ancient books and have not found record of toxicity;

3) Have been listed in National Drug Standards;

4) Maintain the sustainable development of related species resources, do not exert adverse impact on wild medicinal herb resource and ecological environment, and do not belong to wild animals and plants listed in the catalogues of wild animals under national priority protection and wild plants under national priority protection;

5) Comply with requirements of relevant laws and regulations.

Article 39 The food producers and traders shall establish a food safety traceability system which is to record and maintain information related to purchase and inspection and test. The information recorded shall be true, accurate and complete and shall ensure that the food origins and destinations can be traced and responsibilities can be affixed.

The production and trading enterprises of health food, formula food for special medical purpose, formula food for infants and young children, meat products, dairies, edible plant oils and white wine, etc., shall adopt means of informatization to promote the construction of traceability system.

Article 40 The food and drug administrative department under the State Council shall, in conjunction with the agriculture administrative and quality supervisory departments, etc., under the State Council, clarify fundamental requirements on the whole-course food safety traceability and formulate the indexes, transmission formats, interface specifications and coding rules, etc., of the whole-course food safety data collection to realize data connection and information sharing.

Article 41 Social third-parties such as food industry associations are encouraged to invest in and construct traceability information platforms, guide food producers and traders in their construction of traceability systems in a market-driven manner, and provide enterprises with professional service for their construction of traceability systems.

 

Section 2 Process Control of Production and Trading

Article 42 The legal representative or main person in charge of food production and trading enterprises shall be fully responsible for the food safety work in the enterprise, establish and implement the food safety responsibility system.

Article 43 The food safety management staffs shall assist the legal representative or main person in charge of food production and trading enterprises to be responsible for the food safety management work and undertake the following food safety management responsibilities:

1) Be responsible for the management of suppliers;

2) Be responsible for the management of incoming product inspection and food shipment inspection and for the truthfulness of record;

3) Organize and develop food safety enterprise self-inspection and be responsible for truthfulness of self-inspection report;

4) Supervise and implement the control system for food production and trading;

5) Organize and implement the food recall;

6) Perform food safety incidents reporting duty;

7) Implement propaganda and training on the food safety laws, regulations, rules and standards as well as food safety professional knowledge.

8) Other obligations prescribed by the laws and regulations.

Article 44 The food safety management staffs shall be equipped with food safety laws, regulations, rules, food safety standards, food safety professional knowledge and food safety management ability that are suitable for their positions.

Article 45 The food producers and traders may entrust third-party professional organizations carry out inspection and assessment on the food safety situation of their food products.

The third-party professional organizations shall have corresponding abilities in food safety professional inspection and assessment and shall be responsible for the truthfulness of the inspection and assessment results issued by them.

Article 46 The food and drug administrative department of the People’s Government at or above province level shall, according to food safety risk levels and food safety supervision and management requirements, popularize good manufacturing practice requirements in larger-scale food production enterprises and food production enterprises of meat products and dairy products, and implement the Hazard Analysis and Critical Control Point (HACCP) system to improve food safety management levels.

Article 47 The producers of foods, food additives and food-related products shall, according to the food safety laws, regulations and rules as well as food safety standards and enterprise standards, conduct self-inspection or entrusted inspection to their produced foods, food additives and food-related products.

The food producers shall take full considerations of the product characteristics, technical features and raw material control conditions, etc., when determining the items of ex-factory inspection. In the event of existence of other provisions prescribed in the laws, regulations, rules and food safety national standards, such provisions shall prevail.

Article 48 The food traders for the sales of health food, formula food for special medical purpose and formula food for infants and young children that are registered shall examine the product registration certificate, check whether or not the content shown is consistent with the product labeling content and the instructions, and keep the hard copy or e-copy of registration certificate.

The food traders for the sales of health food and formula food for infants and young children that are filed shall examine the product filing certificate, check whether or not the information of product labeling and instructions is consistent with the information published on the website of the food and drug administrative department.

Article 49 The food producers and traders shall keep a register of foods and food additives that have passed the shelf life and are spoiled or recalled, and store them in an explicitly labeled place for a timely destruction or removal of harm as well as keep relevant records.

Article 50 The food producers and traders who entrust warehousing & logistics enterprises for food storage and transportation shall conduct investigation to the entrusted enterprises’ safety guarantee ability and strengthen the management of food safety.

The enterprises specializing in the food storage and transportation shall strengthen the management of food storage and transportation process, and ensure that conditions for food storage and transportation can meet the requirements of food safety.

Whoever is entrusted for food storage and transportation shall, according to relevant regulations, check and keep the following documents of entrusting party including the proof of identification, food production and trading license, copy of business license, qualified certification and inspection & quarantine certification, etc.

Article 51 The producers and traders of non-food products specializing in food storage shall, within 30 working days after obtaining the business license, report to the local food and drug administrative department at the county level where it is located for record-filing.

In the event that the units or individuals entrusted for food storage and transportation do not have legal qualifications for food trading or they store and transport food whose origins are not traceable, the producers and traders of non-food products specializing in food storage and transportation shall report to the local food and drug administrative department at the county level where it is located for record-filing.

Article 52 Where the food storage and transportation require temperature and humidity control, the heat preservation facilities and cold storage and refrigeration facilities shall be equipped and run with high efficiency.

In the process of food storage and transportation, non-edible chemical substances and other substances with potential harm to human health are not allowed to be added, and the food additive cannot be used beyond its scope and maximum limits.

The relevant departments of the People’s Governments at or above the county level shall take effective measures to guide and support the food cold-chain transportation.

Article 53 Records of food storage and transportation shall be kept for traceability.

For entrusted food storage and transportation, both parties shall sign a written agreement, in which the respective rights and obligations concerning food safety of both sides are clearly defined.

Article 54 In the event that such information as complaints & reports and cases investigation indicates that producers and traders of non-food products have potential violations of food safety laws, regulations and national food safety standards in the food storage & transportation activities, the food and drug administrative department shall timely deal with them according to relevant laws.

Article 55 In the event that catering service providers entrust the tableware and drink- ware disinfection service units for disinfection, both sides shall sign the entrustment contract, check and keep the following documents such as business license and qualified disinfection certificates, etc.

Article 56 The tableware and drink-ware disinfection service units shall set up full- time or part-time sanitary administrators, establish and improve the sanitation management system and documents thereof, and carry on the production and trading activities according to the requirements of hygienic practice.

Article 57 The education administrative department at or above the county level shall be responsible for inspection and information reporting of food safety work of schools and kindergartens within its administrative region, and shall timely report to the food and drug administrative department at the same level in case that illegal food safety behaviors are detected.

Article 58 Any unit equipped with canteens such as schools, kindergartens, nursing institutions for the aged, medical institutions and construction sites shall bear the duties of food trading enterprises to carry on self-inspection to canteen food safety, check the hidden dangers & risks, and regularly submit self-inspection report to the food and drug administrative departments of the People’s Government at the county level where it is located.

Any unit who contracts canteen to the other party shall, according to the requirements of laws and regulations, execute the food safety duties, bear the food safety legal obligations, and strengthen supervision and inspection, supervise and urge the contractor to implement the food safety management system. Both parties shall sign the written agreement, in which the respective rights and obligations concerning food safety of both sides are clearly defined.

Article 59 The institution assigned by the People’s Government at or above the county level shall strengthen the supervision and guidance on dinner party activities in rural areas, specify the food safety management requirements for dinner party activities, so as to avoid the food safety incidents.

Article 60 In the event that catering service providers employ catering service management company for management, both parties shall sign the entrustment contract, in which the respective rights and obligations concerning food safety of both sides are clearly defined. Catering service providers shall bear the legal liability of food safety.

Article 61 Third-party online food trading platform providers shall report to the food and drug administrative department at or above the county level at the place where it is located for record-filing and obtain file number within 30 working days after obtaining the approval by the telecommunication administrative department.

The food producers and traders trading through self-established websites shall report to the food and drug administrative department at the city or the county level at the place where it is located for record-filing and obtain file number within 30 working days after obtaining the approval by the telecommunication administrative department.

The food and drug administrative department at the province, city and county level shall publish record-filing information within 7 working days after the completion of record-filing.

Record-filing information includes the domain name, IP address, Telecommunication Business Operations Permit, company name, name of the legal representative or the principal and file number etc.

Article 62 Third-party online food trading platform providers shall properly keep the registration information, trading data and others of the food, edible agricultural product and food additive producers and traders who use the platform and report them to the food and drug administrative department of local People’s Government at or above the county level according to the provisions of the food and drug administrative department under the State Council.

Article 63 Third-party online food trading platform providers shall establish the systems of food trader inspection and registration, food safety self-inspection, food safety illegal behavior stopping and reporting, suspension of serious illegal platform service and food safety complaining, reporting and disposal etc., and shall publish such systems on their online platforms.

Third-party online food trading platform providers shall establish dedicated online food safety management institution or designate dedicated food safety management staff to inspect online food trading behaviors and information.

Article 64 Local food and drug administrative department at or above the county level may, according to the field inspection, inquiry of duplicated trading data and review of trading technical monitoring documents etc., to inspect the third-party online food trading platform providers’ execution of their duties prescribed in the food safety laws, regulations and rules.

Article 65 Under any of the following circumstances, the food and drug administrative department and other departments may have an accountability conversation with the legal representative or main principal of the third-party online food trading platform provider and food producer and trader who uses the platform:

1) Occurrence of food safety problem, which may result in the spread of food safety risk;

2) Failure to handle food safety problem complained and reported in time, which may imply potential food safety risk;

3) Failure to take effective measures in time to identify and remove food safety hidden danger, and fulfill the food safety responsibility;

4) Other circumstances deemed necessary for the accountability conversation by the food and drug administrative department under the People’s Government at or above the county level.

Article 66 Under any of the following circumstances, the third-party online food trading platform provider shall immediately stop providing online trading platform service to the food producer or trader who uses the platform:

1) The food producer or trader who uses the platform is a suspected of constituting a food safety crime and is under case filing and investigation or public prosecution;

2) The food producer or trader who uses the platform is sentenced criminal penalty by the People’s Court due to food safety crime;

3) The food producer or trader who uses the platform is detained or is given public security management punishment by the public security organ due to food safety illegal behavior;

4) The food producer or trader who uses the platform is punished of revocation of the license or is ordered of production or operation suspension by the food and drug administrative department or other related department.

Article 67 Food producers and traders shall stop producing & trading, recall and dispose unsafe food according to relevant provisions of national food recall system.

based on the seriousness and urgency degree of food safety risks, food recall applies level-by-level administration:

Level 1 recall: where the food has caused or may cause serious health damage or death after consumption, food producers and traders shall initiate the recall within 24 hours after knowing of the food safety risks;

Level 2 recall: where the food has caused or may cause ordinary health damage after consumption, food producers and traders shall initiate the recall within 48 hours after knowing of the food safety risks;

Level 3 recall: where the food label or description dose not conform to food safety standard, and no health damage is caused in generally, food producers and traders shall initiate the recall within 72 hours after knowing of the food safety risks. For food with flaws of its label or mark and harmless to health, food producers and traders shall make corrections and may recall the food at its own discretion.

Food producers and traders who conduct food recall shall report relevant information to the food and drug administrative department of local People’s Government at or above the county level where it is located within the time limit specified by different recall levels.

Article 68 Food producers and traders shall take actions such as removal of harm, destruction or remedy for foods that have exited the market due to cease of production & trading and recall.

Food producers and traders shall destroy on the spot the food that harms health included in the Article 43 of the Law on Food Production and Trading.

Food producers can continue to sell recalled food due to the label and mark not conforming to food safety standard in case remedy has been done and the food safety can be ensured. The remedy shall be expressly notified to customers by posting a notice at conspicuous position of trading place and other means when selling such foods.

The local People’s Government at or above the county level shall set up special fund to organize the implementation of storage, removal of harm and destruction, etc. of unsafe food involved.

Article 69 For food requiring irradiation, the food producers and traders shall entrust the unit with irradiation qualification to conduct inspection and indication in accordance with the relevant food irradiation standards.

Irradiated food raw materials, if used, shall be indicated according to relevant regulations.

Food producers and traders shall timely report the situation of irradiated food and use of irradiated food raw materials to the food and drug administrative department under the People’s Government at the county level where it is located.

 

Section 3 Edible Agricultural Products Marketing and Sales

Article 70 The founder of the central trading market for edible agricultural products shall report the information such as the name of the market, type of the market, address, legal representative or main principal, supervisor for food safety, supervision system for food safety, type of agricultural products, number of the booths, and etc. to food and drug administrative department of the People’s Government at the county level for file-recording.

Article 71 The funder of the central trading market for edible agricultural products shall bear the following management responsibilities for the quality and safety of the edible agricultural products trading in the market:

1) Establish and improve the management system for safety of edible agricultural products and the recording archive for the admitted sellers of edible agricultural products, and supervise and urge the sellers to execute their duties;

2) Equip inspection equipment and technicians, or delegate inspection agency which is accredited, to conduct sampling inspection or speedy inspection of the edible agricultural products, and publish results of inspection;

3) Require the sellers to immediately stop selling and conduct harmless treatment to or destroy the edible agricultural food and report to the food and drug administrative department under the People’s Government at the county level when behaviors related to the edible agricultural food are found incompliant with the food safety standards and other related standards.

Article 72 The funder of the central trading market for edible agricultural products shall bear the responsibilities to verify the following documents:

1) Seller’s code of social credit or copy of ID card;

2) Place of origin certificate or purchasing proof of the edible agricultural food;

3) Compliance proof of the edible agricultural food production enterprise and farmer professional cooperation economic organization.

For those who cannot provide the mentioned documents, the founder of the market shall conduct sampling inspection or speedy inspection. only compliant sellers upon sampling inspection or speedy inspection can be allowed to enter into the market.

Article 73 Sellers of meat products of poultry and livestock shall provide quarantine certificate stamped with the quarantine mark according to law.

Sellers of meat products of poultry and livestock shall also provide meat quality inspection qualification certificate according to law.

Sellers of imported edible agricultural foods shall provide proof documents such as entry goods inspection and quarantine certificate and customs clearance documents etc.

Article 74 For the unpacked edible agricultural products entering into the wholesale and retail market, information like the name, origin, producer’s name or the seller’s name or first name and family name shall be publicized in a visible place in the booth (counter).

Article 75 Sellers of edible agricultural products shall verify related proof documents and shall not purchase or sell in case of incompliance.

The sellers shall establish the stock checking scheme by honestly recording the name, quantity, stock entry date of the edible agricultural products, and the name, address, contacts of the suppliers, and the relevant certificates shall be archived. The record and certificates shall be kept no less than 6 months.

For the enterprise using centralized distribution mode, the integrated in-stock checking and recording system can be established at its headquarters. All of its sales stores shall keep the distribution lists and the corresponding compliance certificates. The distribution lists and the corresponding compliance certificates shall be kept no less than 6 months.

Sales enterprises engaging in wholesales of edible agricultural products shall establish the edible agricultural products sales record system by honestly recording the name, quantity, sales date of the edible agricultural products, and the name, address, contacts of the buyers, and the relevant certificates shall be archived. The record and certificates shall be kept no less than 6 months.

 

Section 4 Label, Description and Advertisement

Article 76 Food and food additive producers shall be responsible for the contents in the label and description of food and food additives that they produced.

Food and food additive producers and traders shall not change production date, shelf life and other information indicated in the label and description against the provisions.

Article 77 The edible agricultural products that shall be packed or labeled according to relevant regulations are allowed to be sold after packing and labelling. The packing or label shall indicate the name, origin, producer and production date etc. of the edible agricultural product according to relevant regulations. The shelf life shall be indicated if the shelf life is regulated. The shelf life shall be indicated if it varies per storage condition. The name of the food additive, if used, shall be indicated.

Article 78 The packaged edible agricultural products through primary processing such as clean and cut shall be indicated of shelf life and sold within shelf life.

Article 79 The food that are produced directly with GMO materials shall be labeled prominently according to relevant provisions.

Genetically modified food shall be labeled according to relevant provisions in the Administrative Regulations on Agricultural Genetically Modified Organisms Safety.

Article 80 For substances that shall not be contained or used according to food safety standard, words as “not added” and “not contained” shall not indicated in the food label, description or advertisement. For genetically modified food and materials that are not approved by the State yet, words as “Non- GMO” shall not be indicated.

Health food shall only indicate its healthcare functions approved in its registration certificate. Other food other than health food shall not express or imply health functions on any carriers by any means.

Relevant contents on the label and description of health food, formula food for special medical purpose and formula food for infants and young children shall be consistent with the registered or filed contents and shall indicate the registration number or file number.

Irradiated food shall indicate “Irradiated Food” in the label and description; and the ingredients through irradiation shall be indicated in the list of ingredients.

Article 81 Food producers shall indicate in the list of ingredients if the ingredient contains substances that may result in allergic reaction.

 

Section 5 Special Foods

Article 82 The formula of health food, formula food for special medical purpose and formula milk powder for infants and young children subject to registration administration to be produced, sold or imported shall obtain registration certificate issued by the food and drug administrative department under the State Council.

Article 83 The catalogue of raw materials of health food and the catalogue of approved health functions to be claimed by health food shall implement dynamic management according to the progress of scientific research and health food registration situation.

Article 84 Relevant technical requirements such as raw material name, dosage level, corresponding efficacy as well as production technologies, functional ingredients and test methods shall be published when the catalogue of raw materials of health food is published.

Raw materials in the catalogue of raw materials of health food whose raw material ingredient, dosage level and corresponding efficacy have been changed due to the change of production technics shall apply for registration as raw materials excluded in the catalogue of raw materials of health food.

Functional health raw materials that are not intended to provide nutrients shall be managed as raw materials of health food and shall not to be applied for use as new food raw material. Other foods other than health food shall not use raw materials that shall be used only for health food.

For health food that is imported for the first time and is of nutritious substances such as vitamin and mineral supplements, its nutritious substances shall be the substances included in the catalogue of raw materials of health food.

Article 85 Dynamic production process with regard to implementation of on-site inspection of health food production licensing applicant’s production site shall be inspected, and trial sample produced shall be sampled on site for inspection.

Article 86 The food and drug administrative department under the State Council shall entrust qualified food inspection institutions to undertake the sampling inspection tasks for registration of the formula of health food, formula food for special medical purpose or formula milk powder for infants and young children and make the list to the public.

The applicant of registration of the formula of formula food for special medical purpose or formula milk powder for infants and young children shall an enterprise that has corresponding research and development abilities, production abilities and inspection abilities suitable for the registered formula food for special medical purpose or formula milk powder for infants and young children, and shall establish the production quality management system suitable for the food it produces according to good production practices.

Article 87 The production enterprises of health food, formula food for special medical purpose and formula food for infants and young children shall organize production according to the technical requirements of product formulas and production technologies registered or filed.

The enterprise standards of producers of special foods shall meet the requirements of product technologies registered or filed.

In case the production technologies of health food involve such pretreatment processes as extraction and purification of raw materials, the production enterprises must have corresponding raw material pre-treatment ability with regard to the production varieties and scale.

Production enterprises of formula food for infants and young children can sell its products in the market only after raw materials, food additives, product formula, label and other items thereof have been filed for record and made public.

Article 88 The applicant who applies for registration of health food, shall organize to conduct relevant research work, complete product production in production enterprise that meets good manufacturing practices for health food, and submit inspection report issued by inspection institution with legal qualification.

Article 89 For health food subject to record-filing management according to laws, food and drug administrative department shall do well such work as record-filing, publication and future reference of filed information according to provisions, and issue filing certificate and filing registration number to filing applicant.

Article 90 The health food function claim shall meet the requirements for the catalogue of health functions and be indicated strictly according to the content registered or filed, and random addition/deletion or combination of words is forbidden.

Article 91 Food sales enterprises shall set up sales counter or sales area for health food, formula food for special medical purpose and formula food for infants and young children, and “Health Food Sales Area or Counter”, “Formula Food for Special Medical Purpose Sales Area or Counter” and “Formula Food for Infants and Young Children Sales Area or Counter” shall be indicated at conspicuous position of sales counter or sales area. Mixed storage of health food, formula food for special medical purpose and formula food for infants and young children with drugs or common food is forbidden.

In addition, “The product is not drug substitute” shall be indicated at conspicuous position of health food sales counter or sales area.

Among formula food for special medical purpose, special total nutrient formula shall be sold in medical institutions or pharmaceutical retail enterprises and shall not be sold online, and others can be sold in food trading places and online.

Article 92 The applicant of registration of special total nutrient formula food in the formula food for special medical purpose shall conduct clinic trial and submit clinic trial report.

Article 93 Production enterprises of formula food for special medical purpose shall conduct inspection on the products to be delivered per product batch and per inspection item prescribed in the food safety national standard.

Article 94 Among formula food for special medical purpose, the advertisement of special total nutrient formula shall be subject to examination and approval administration for prescription medicine advertisement, and the advertisement of others shall be subject to examination and approval administration for over the counter medicine advertisement.

Article 95 The product name and label of formula food for infants and young children shall be true and standardized, scientifically accurate, easy-to-understand and clearly identifiable. The detailed information of the origin of the raw material shall be honestly indicated and shall not contain either fake, exaggerative or absolute language or content level claim and function claim.

The advertisement of formula food for infants and young children shall not contain promotion of content level and functions.

For registration of formula milk powder for infants and young children, the consistence of the label, description and content of the registered product formula shall be reviewed.

Article 96 Production enterprises of formula milk powder for infants and young children shall not produce and sell formula milk powder for infants and young children, the trademark, enterprise name and address of which are registered in overseas only, and not produce formula milk powder with milk and milk component products of other animals other than cow and goat.

The product formula to be applied for registration shall be developed according to the rules of healthy growth of infants and young children and be compliant with relevant laws and regulations and national food safety standards. The formulas of products for two or more age groups to be applied for registration by same enterprise shall have obvious differences which can be proved by scientific evidence. In principle, each enterprise shall not have over 3 series and 9 product formulas.

A group enterprise’s wholly-owned subsidiary that has obtained registration and production license of formula milk powder for infants and young children may use the existing registered product formula of formula milk powder for infants and young children of the same group enterprise’s another wholly-owned subsidiary. Before production organization, the group enterprise shall submit a written report to the food and drug administrative department under the State Coucil.

Substances that can be optionally added according to national food safety standard shall not be reflected in the name of formula food for infants and young children.

Formula milk powder for infants and young children shall not be sold in limited areas and specially produced for retailers.

Article 97 The same enterprise shall not register or file special foods of different brands by using the same formula and shall not register or file special foods of different formulas by using the same name.

 

Chapter 5 Food Inspection

Article 98 Food inspection shall be conducted by the food inspection institution that is qualified and accredited according to relevant laws and regulations and food inspection work criteria and food standards. The food inspection institution and its inspectors shall respect science, stick to the professional ethics and ensure the inspection data and conclusion that they have issued are objective, just, accurate and traceable, and shall not issue fake or untrue data and result-contained inspection report.

The food and drug administrative and quality supervisory department shall perform random sampling inspection on the foods, food additives and food related products according to the division of responsibility. The food safety supervision and sampling inspection shall be performed according to the food safety standards, product technology requirements registered or filed according to law and the inspection items and test methods stipulated in relevant national regulations.

The works such as case inspection, accident investigation and emergency response, etc. can adopt the inspection items and test methods not stipulated in the food safety standards, to analyze and find the reasons for food safety problems. In case of adopting the test methods not stipulated in the food safety standards or not regulated by the State, it shall follow the principle of scientific, advanced and reliable technical means, and get the permission from the food and drug administrative and quality supervisory departments under the People’s Government at or above the county level.

Article 99 When carrying out the sampling for food safety supervision and sampling inspection, the food and drug administrative and quality supervisory department can sample by itself, or entrust the food inspection institutions with statutory qualification for sampling, the number of sampling person shall not be less than two.

For case inspection and accident investigation, the sampling shall be organized by officer with law enforcement qualification, and shall not be restricted by such factors as sampling amount and site and whether the sampled unit has the quantification.

Article 100 For sampling inspection of foods being traded online, the food and drug administrative department shall determine the purchaser of sample, payment account, registered account, delivery address, contact information, save the purchasing bill, and record the name, type and quantity, etc. of samples drawn for sampling inspection.

Upon reception of sample, the sampling person shall check the mailed pack etc., have the sample and reserved sample respectively sealed, and record the unpacking process by taking photos and videos etc.

Article 101 The food and drug administrative department organizing and implementing supervision and sampling inspection of food being traded online shall timely notify the received inspection result as unqualified to the sampled food producers and traders; in case of purchasing through the third-party online trading platform, the third-party online trading platform provider shall be notified simultaneously.

In case the addresses of producers and traders of food being trade online are unknown, they can be notified with the assistance of the third-party platform provider. In case it is disqualified upon inspection, and the producers and traders of food being traded online are not available, it can require the third-party platform provider to remove the online food sales information and suspend to provide trading service on third-party platform.

Article 102 In case of being qualified upon food safety supervision and sampling inspection, the institution undertaking the inspection shall submit the inspection report to the food and drug administrative department organizing and carrying out the supervision and sampling inspection within 10 working days. In case of being unqualified upon inspection, the institution undertaking the inspection shall timely report to the food and drug administrative department organizing and carrying out the supervision and sampling inspection.

For cross-region supervision and sampling inspection, in case it may have great harm to public health and life as indicated in the inspection conclusion of disqualification received by food and drug administrative department, the inspection result shall be notified to the local food and drug administrative department of sampled food producers and traders, and the local food and drug administrative department of producers and importers marked on the package or label.

Upon reception of notification, the food and drug administrative department shall immediately notice the relevant food producers and traders to take such measures as halting production and trading and recalling unsafe food, eliminate and control the food safety risk, and conduct investigation and handling in a timely manner. In case food producers and traders fail to fulfill relevant obligations in accordance with relevant provisions, the food and drug administrative department shall order them to fulfill the obligations thereof.

Article 103 If application of computer and information technology or automatic equipment system to collect, record, process, analyze, report and store inspection data and relevant information, the inspection institutions shall completely verify the compliance and suitability of the above work to relevant national regulations and requirements and keep the record verified. The validity of the electronic inspection reports by the inspection institutions shall be subject national laws and regulations related to signature and stamping.

The inspection institutions shall establish the food safety risk information reporting system. In case of serious safety problem or regional, systematic and industry-wide food safety risk potential found in the inspection, the inspection institution shall timely report to the food and drug administrative department at or above the county level where it is located and maintain the copies of the written report, inspection report and original records.

Article 104 The People’s Government at or above the county level shall integrate the food inspection resources of the food and drug administrative, quality supervisory, agriculture administrative and health administrative departments, etc., and establish the mechanism for sharing of inspection resources and inspection results.

It is encouraged to include the inspection institutions affiliated to higher education institutions, science research institutes and social third-parities, etc., in the scope of inspection resource integration and sharing.

Article 105 In case food producers and traders have objection on the inspection conclusion, the re-inspection application shall be put forward according to provisions of Food Safety Law.

The re-inspection institution shall submit re-inspection report to food and drug administrative department organizing the sampling inspection work within 10 working days as of the date receiving sample in principle, unless otherwise agreed between food and drug administrative department, re- inspection applicant, and re-inspection institution.

Food producers and traders shall not cease to fulfill relevant obligations such as halting production and trading, and recalling during application of re-inspection.

Article 106 In case of any of the following circumstances, it shall not be re-inspected:

1) where the inspection conclusions indicate that the microbiological indicator is unqualified;

2) where the re-inspection application is put forward exceeding the time limit;

3) where the reserved sample is incapable of achieving re-inspection aim due to other reasons.

Article 107 The re-inspection institution shall adopt arbitration method stipulated in relevant standards for re-inspection, and shall adopt the inspection method consistent with that of initial inspection in case of no arbitration method available. The sample used for re-inspection shall be the reserved sample of re-inspection. After completion of re-inspection, the re-inspection institution shall issue the inspection conclusion about whether the re-inspected sample is qualified.

Article 108 Relevant expense of re-inspection is paid by re-inspection applicant in advance. In case the re-inspection conclusion is consistent with initial inspection conclusion, inspection expense shall be borne by the re- inspection applicant. In case the re-inspection conclusion is inconsistent with initial inspection conclusion, inspection expense shall be borne by the initial inspection institution.

Article 109 The re-inspection institutions that have relevant re-inspection qualifications shall actively perform re-inspection tasks, implement re-inspection activities in a just and standard manner, and shall not reject or shirk re-inspection tasks. The re-inspection institutions that do not accept re-inspection tasks for two times in a year shall be disqualified and the information shall be made to the public.

 

Chapter 6 Food import and Export

Article 110 The entry-exit inspection and quarantine authorities shall in accordance with provisions of Food Safety Law and the Rules, implement supervision and administration on import & export and frontier port food of foods, food additives and food related products.

The national entry-exit inspection and quarantine authorities shall make public to the society the inspection and quarantine supporting document of foods and food additives, for free query by the public.

Article 111 The national entry-exit inspection and quarantine authorities shall implement graded and classified administration on import food in accordance with the responsibility, based on the food safety risk, enterprise food safety control ability, food safety condition of exporting country or regions, etc.

Article 112 When importing foods, food additives and food related products, the importer or its agent shall apply for declaration to the entry-exit inspection and quarantine authorities with necessary certificates such as contract, invoice, packing list and bill of lading, etc. and relevant standard documents. As for declaration, the qualified certification materials shall be attached in accordance with the requirements of the national entry-exit inspection and quarantine authorities.

In case of importing health food, formula food for special medical purpose and formula milk powder for infants and young children requiring registration or record-filing management, the importer or its agent shall submit the supporting documents obtaining registration and record-filing in accordance with provisions of Food Safety Law and the Rules to entry-exit inspection and quarantine authorities. The entry-exit inspection and quarantine authorities shall implement supervision and sampling inspection in accordance with the requirements set out in the registered or filed supporting documents.

The national entry-exit inspection and quarantine authorities shall inspect imported formula food for infants and young children per batch according to all the items stipulated in the relevant food safety standards.

For imported edible animal and animal products, the inspection and quarantine certification materials, such as Entry Goods Inspection and Quarantine Certificate, Animal Quarantine Certificate, and Inspection and Quarantine Handling Notification etc., shall also be attached in accordance with the requirements of the quality supervisory, inspection and quarantine department under the State Council.

The customs shall release the goods based on the Customs Clearance Certificate issued by entry-exit inspection and quarantine authorities, and publicize on the official website.

Article 113 The supervision and sampling inspection of exported food shall be performed by entry-exit inspection and quarantine authorities. In case there are requirements available in international treaty and protocol, the entry-exit inspection and quarantine authorities shall carry out the supervision and sampling inspection in accordance with requirements of international treaty and protocol.

Article 114 The entry-exit inspection and quarantine authorities shall implement supervision and sampling inspection on import links of foods, food additives and food related products according to imported/exported commodities inspection-related laws, administrative regulations and food safety national standards. For those entering the domestic market for sales, the supervision and sampling inspection shall be implemented by food and drug administrative department.

The entry-exit inspection and quarantine authorities shall implement detention and inspection on foods, food additives and food related products with high safety risk; for those with common risk, the sampling inspection shall be implemented; for those with low risk, the on-site inspection shall be implemented.

Article 115 The overseas exporters and overseas food producers exporting food to China shall guarantee that the food exported to China conforms to Food Safety Law, provisions of other relevant laws and regulations, and requirements of national food safety standards. importers shall establish examination system of overseas food exporters and overseas food producers.

Article 116 In case the importers recall imported foods, the exit-entry inspection and quarantine authorities shall notify the food and drug administrative departments at the same level.

Article 117 The overseas food producers, overseas exporters and their agents exporting food to China shall take effective measures to prevent edible agricultural products and food from man-made deliberate destruction of chemical, biological and physical manner during the processes such as planting and breeding, raw and auxiliary materials control, production, package, storage, and transportation.

Article 118 For the overseas food production enterprise which has passed Good Manufacturing Practice and Hazard Analysis and Critical Control Point system certification, the certification authority shall implement tracking investigation according to law. For enterprises no longer complying with certification requirements, the certification authority shall revoke the certification according to law. The quality supervisory department under the State Council shall timely notify it to the food and drug administrative department, etc., under the State Council, and make it public to the society.

Article 119 For imported health food, formula food for special medical purpose, and infants and young children formula milk powder, the food and drug administrative departments under the State Council can organize the on-site verification on the quality management system of producers thereof, as well as the implementation and record-filing of good manufacturing practice for food.

Food producers and traders shall not, in the name of non-health food, import and use the food only used for production and processing of raw materials of health food.

Article 120 In case food safety accidents or other public health events occurred at abroad may affect China, or serious food safety problems are found in imported foods, food additives, food related products, the national entry-exit inspection and quarantine authorities shall timely release imported food safety risk warning information, and take the following control measures:

1) to implement and strengthen supervision and detaining inspection;

2) to carry out return or destruction;

3) to restrict the import with reservations;

4) to suspend or prohibit the import;

5) to initiate the emergency response plan for imported food.

Article 121 In case of importing and exporting food in the form of cross-border electronic commerce, it shall comply with relevant provisions on food import and export in Food Safety Law and the Rules. Supervision and administration of importing foods, food additives and food related products in the form of cross-border electronic commerce shall be separately formulated by the quality supervisory, inspection and quarantine department under the State Council, in conjunction with relevant departments under the State Council.

 

Chapter 7 Handling of Food Safety Accidents

Article 122 Level-by-level administration shall be applied in handling of food safety accidents.

In case of especially major food safety accidents, the food and drug administrative department under the State Council shall conduct investigation and handling in conjunction with relevant departments under the State Council, under the unified leadership of the State Council.

In case of major, relatively major and general food safety accidents, the food and drug administrative department under the People’s Government at province, city and county levels shall conduct investigation and handling in conjunction with relevant departments at the same levels, under the leadership of the People’s Government at the corresponding level.

Article 123 The People’s Governments at the provincial level shall make emergency response plans for food safety accidents, and amend and improve in time according to changes in actual situation.

The local People’s Government at or above the county level shall do well in the management of emergency response plan for food safety accidents, and strengthen supervision, inspection and guidance of the management of emergency handling by food production and trading enterprises.

The local People’s Government at or above the county level shall incorporate the training on emergency response plan for food safety accidents into leaders and cadres training, public servants training, and daily training of emergency response management cadres.

Article 124 The People’s Governments at the provincial level shall make the plans for food safety emergency response system construction.

The local People’s Government at or above the county level shall improve the food safety emergency response management authority, perfect the emergency response management system, put the emergency response funds in place, improve the emergency response equipment, do well in emergency response materials storage and emergency response team construction, and strengthen emergency response training, drills and evaluation.

The local People’s Government at or above the county level shall carry out the monitoring and early warning of food safety accidents, strengthen the collection, analysis and study and judgment of information related to food safety, and release early warning information in time based on the emergency degree, development trend and the degree of possible hazard of food safety accidents.

Article 125 The food and drug administrative department under the People’s Government at or above the county level shall, in conjunction with the health administrative department at the same level, set up the food safety accident information monitoring and reporting system, set up the food safety accident information direct reporting network system covering food producers and traders above the designated size, third-party online food trading platform, medical institutions, disease prevention and control organs and others.

Article 126 Food production and trading enterprises shall set up the food safety emergency response management system, make the incident handling plan and establish the emergency incident reporting system.

The food production and trading enterprises above the designated size and relevant units shall organize and carry out emergency response drills regularly.

Article 127 The unit where the food safety accident has occurred shall take such control measures as sealing up immediately food and raw materials, tools and equipment which has caused or is likely to cause the food safety accident. Both the unit of the accident and the unit receiving patients for medical treatment shall report to the food and drug administrative and health administrative departments under the People’s Government at the county level where it is located within 2 hours upon discovery of the incident.

The health administrative department shall immediately organize the disease prevention and control institution to conduct sanitary treatment of the incident site, and conduct an epidemiological investigation into factors related to the food safety accident, and relevant departments shall provide assistance. The disease prevention and control institution at or above the county level shall submit the preliminary epidemiological investigation report to the health administrative department and the food and drug administrative department at the same level within 24 hours, and submit the final investigation report within 7 working days upon the end of the investigation.

In case that the medical institution or the disease prevention and control institution has discovered that the patient treated and the public health emergency incident handled may be related to the food safety accident, it shall report to the food and drug administrative department and the health administrative department under the People’s Government at the county level where it is located within 2 hours.

In case that the disease prevention and control institution and such technical institution as food inspection have discovered the food safety accident information, they shall report to the food and drug administrative department under the People’s Government at or above the county level within 2 hours.

Article 128 In case that medical institutions have discovered that the patients that they have received are of patients of foodborne diseases or suspected patients of foodborne diseases, they shall timely report the related information to the health administrative department under the People’s Government at or above the county level where it is located. In case that the health administrative department under the People’s Government at or above the county level considers that it is food safety related, it shall notify the food and drug administrative department at the same level within 2 hours.

The health administrative department under the People’s Government at or above the county level shall set up the foodborne disease monitoring and reporting work system and organize the disease prevention and control institution to verify the disease information reported, in conjunction with the food and drug administrative department at the same level.

In case that the health administrative department under the People’s Government at or above the county level has discovered the information related to food safety accident during the investigation and handling of epidemic disease or other sudden public health incident, it shall notify the food and drug administrative department at the same level within 2 hours.

Article 129 In case that the quality supervisory, the agriculture administrative and other relevant departments at or above the county level have discovered the food safety accident information, they shall notify the food and drug administrative department at the same level forthwith. In case that the food and drug administrative department has discovered that the food safety accident information involves relevant department, it shall notify relevant department forthwith.

Article 130 Under any of the following circumstances, the food and drug administrative department at or above the county level shall, in conjunction with the health administrative, agriculture administrative, quality supervisory and other relevant departments at the same level shall conduct investigation and handling in a timely manner:

1) Foodborne disease caused by food provided by the food producers and traders;

2) Food contamination resulting from human or other factors during production, processing, storage, transportation, and catering service by the food producers and traders, which has resulted or is likely to result in personal injury to the public.

3) Other food contamination and harmful factors have resulted or is likely to result in personal injury to the public.

Article 131 In case of food safety accident, the food and drug administrative department will conduct investigation and handling and confirm the cause, nature and liability of the accident, in conjunction with health administrative, agriculture administrative, quality supervisory, public security and other departments.

Upon the end of the food safety accident investigation, the food and drug administrative department shall submit the final investigation report of food safety accident to the People’s Government at the same level and the food and drug administrative department at the higher level as required.

In case of the need to initiate the emergency response plan due to occurrence of the food safety accident, the People’s Government at or above the county level shall set up an incident handling command body forthwith to initiate the emergency response plan.

Article 132 The emergency response plan and investigation and handling of other food safety incidents other than food safety accidents shall be governed by relevant provisions in this Chapter.

 

Chapter 8 Supervision and Management

Article 133 The food and drug administrative department under the State Council is responsible for special food registration and related filing, organizing and conducting the relevant system inspection and the national food safety supervision and sampling inspection, setting up the unified food safety information platform, announcing major food safety supervision and management information under the law, carrying out inspection of major food safety irregularities, bearing the related responsibility of investigating and handling especially major food safety accidents under the law and preventing and controlling the systematic food safety risks.

The food and drug administrative departments under the People’s Governments of provinces, autonomous regions and municipalities are responsible for special food production licensing, organizing and conducting food safety supervision and sampling inspection at the province level, announcing the food safety information within the region under the law, carrying out inspection of food safety irregularities, handling major food safety accidents under the law and preventing and controlling the regional food safety risks.

The food and drug administrative departments under the People’s Governments at the city and county level are mainly responsible for food production and trading licensing, conducting daily food safety supervision, inspection and sampling inspection, announcing the food safety information within the region under the law, supervising over the enterprise’s product recall, and investigating and handling food safety violations under the law. Focus shall be placed on daily supervision, inspection and sampling inspection of the food and edible agricultural products wholesale and retail markets, malls and supermarkets, and catering service units, the pesticide residue or veterinary drug residue in the raw materials of food sold or purchased, and the food produced and traded by food production and processing small workshops and food vendors within the administrative region.

Article 134 The food and drug administrative department under the State Council may establish resident agencies according to the work requirements, supervising and inspecting the food safety tasks of local People’s Government.

Article 135 The State sets up the food safety inspector system. The food and drug administrative departments will set up full-time food safety inspectors teams, conducting on-site inspection of the situations of implementation of good operational norms, hazard analysis and critical control points system implementation of food production and trading enterprises and high-risk food production and trading enterprises with a focus on those above the designated size, and daily supervision and investigation shall be conducted according to relevant regulations.

Article 136 In case that the food and drug administrative, quality supervisory and other departments have discovered food spoilage, mildew and rot, mixture of foreign substance and other abnormalities in sensory properties of the food during the on-site supervision and inspection, they may collect evidence by taking photos and videos etc.

Article 137 If the signature of the food producer or trader is required during the food safety supervision and inspection, in case that the person concerned refuses to sign or is unable to sign for other special reasons, the reasons shall be indicated, which may be confirmed by signatures of more than 2 law enforcement officers on site.

Article 138 If the food and drug administrative and quality supervisory departments, etc., will need to inquire the bank accounts of the food producers and traders during the case investigation and handling process, the relevant financial institutions shall provide assistance.

Article 139 Under the circumstances of possible loss of evidence or difficulty to obtain evidence later, the relevant contracts, bills, account books, sale and purchase records, storage equipment of electronic data and other materials may be registered and kept first under the law.

Article 140 In case of case filing and investigation of the food producer and trader by the food and drug administrative department due to suspected food safety violations, the food and drug administrative department may suspend processing its relevant administrative license application during the period of investigation and handling; for the already accepted application, suspend handling, and the period of suspension will not be counted into the administrative license period.

Article 141 Where the food and drug administrative department at the higher level deems it necessary, it may directly investigate and handle the food safety violation cases within the jurisdiction of the food and drug administrative department at the lower level, or designate the food and drug administrative department in other regions to investigate and handle, and the food and drug administrative department where the case has occurred shall provide cooperation.

Article 142 The health administrative department under the State Council shall announce in time the list and the testing method of the discovered non-food chemical substance and other substances which may endanger human health, which is added or may be added into food, according to the foodborne disease information, risk monitoring, risk evaluation and other supervision and management information, in conjunction with relevant departments under the State Council.

Article 143 In case that the food and drug administrative department has investigated to find non-edible substances contained in the food, the food producers and traders shall bear related legal obligations if they cannot provide relevant evidence beyond a reasonable doubt.

Article 144 In case that no residue limit and testing method is specified for pathogenic microorganisms, pesticide residue, veterinary drug residue , heavy metal, biological toxin, pollutants, impurities and fake substances used and other substances which endanger human health, the health administrative department under the State Council shall specify the temporary residue limit and testing method in conjunction with the agriculture administrative, food and drug administrative and other departments under the State Council and announce them to the public, as the basis for production and trading and supervision and management.

Article 145 The food and drug administrative, quality supervisory, agriculture administrative and other departments under the State Council may formulate related management method and technical assessment guide to assess the fast testing methods for food. If the fast testing method meets relevant requirements, it may serve as the fast testing method as provided by the State.

The food and drug administrative, quality supervisory, agriculture administrative and other departments under the People’s Government at or above the county level may adopt the national food safety standards or the fast testing methods regulated by the State to conduct sampling inspection and testing of food.

For food whose testing results have shown that it may not conform to food safety standards, it shall be inspected in accordance with Article 87 of the Food Safety Law, and the enterprises shall take such measures as suspending sale to control risks.

Article 146 For the fast testing method not as regulated by the State, the food and drug administrative department under the People’s Government of provinces, autonomous regions and municipalities may, according to the supervisory management requirements, organize professional technical institutions to carry out assessment of the food fast testing method in accordance with the provisions of Clause 1 of Article 145 of this Implementation Rules. If the fast testing method meets relevant requirements, it may be used for preliminary screening of food safety by the food and drug administrative department under the People’s Government of provinces, autonomous regions and municipalities within the jurisdiction.

Article 147 The food and drug administrative department and other departments under the State Council shall set up the food producers and traders credit supervision and management system, strengthen disclosure of negative information and punishment of incredibility, and promote the linking up between food safety credit evaluation results and industry access, financing credit, security issuance, enterprise credit investigation and other credit system.

In case that the food and drug administrative department has made the decision of penalty with regard to the food safety illegal behaviors, it shall publish the written administrative penalty decision within 20 working days after such written administrative penalty decision is made.

Article 148 The health administrative department under the People’s Government at the county level shall carry out timely supervision and inspection of units carrying out centralized disinfection of tableware and drink-ware, and shall investigate and handle in time in case of discovery of non-compliance with the laws, regulations, food safety standards and relevant hygienic code, and announce the supervision and inspection results to the public.

Article 149 Under any of the following circumstances, the food and drug administrative department and other departments may have an accountability conversation with the legal representative or main principal of the food producer and trader:

1) Occurrence of food safety problem, which may result in the spread of the food safety risk;

2) Failure to handle food safety problem complained and reported in time, which may carry potential food safety risk;

3) Failure to take effective measures in time to identify and remove food safety hidden danger, and fulfill the food safety responsibility;

4) Other circumstances deemed necessary for the accountability conversation by the food and drug administrative department under the People’s Government at or above the county level.

The accountability conversation will not affect the administrative resolution made by the food and drug administrative department, etc., under the law, and the accountability conversation and follow-up handling shall be announced to the public.

In case that the interviewed fails to implement rectification for no justified reasons, the food and drug administrative department shall increase the frequency of supervision and inspection.

Article 150 The People’s Government at or above the county level shall be liable for localized management of food safety guarantee for important activities, make the food safety guarantee plan, specify food safety responsibilities, and put the guarantee funds and conditions in place.

The important activity organizer shall specify the food safety management authority, choose the food producer and trader with food safety guarantee ability, enhance supplier review and food inspection, and urge it to fulfill the food safety obligations. When necessary, they may engage professionals for assessment.

The food producer and trader providing food for important activity shall assume main responsibility for food safety under the law, make the food safety guarantee plan and emergency response plan, and implement the whole-process control requirements over the food safety to ensure food safety.

The food and drug administrative under the People’s Government at or above the county level shall, in junction with the health administrative, agriculture administrative, quality supervisory and other departments, strengthen food safety guarantee of important activity according to the food safety guarantee plan, and strengthen supplier review and food inspection. When necessary, they may engage professionals for assessment.

important activity organizer is encouraged to engage social professional institutions to provide food safety guarantee service for important activity.

Article 151 The food and drug administrative department and other departments under the People’s Government at or above the county level shall set up the food safety complaint and reporting organ, announce the food safety complaint and reporting hotline, and establish the complaint and reporting network information management system.

The food safety complaint and reporting acceptance organ shall regularly summarize and analyze food safety complaint and reporting information, and put forward suggestions to improve food safety supervision and administration.

Article 152 The food and drug administrative department under the State Council shall make standards for the food safety supervision and administration ability construction, and specify requirements on ability construction of food and drug administrative organs, personnel, facilities and equipment at various levels, in conjunction with relevant departments under the State Council.

The People’s Government at or above the county level shall incorporate funds for food production and trading administrative licensing, risk monitoring and assessment, food safety standard revision, supervision and inspection, sampling inspection, publicity and education, ability construction etc. into the financial budget of the government at the same level, and set up special funds for emergency handling, case investigation and handling, reporting reward, important activity guarantee and etc.

The law enforcement vehicles for food safety supervision and management shall incorporate into the management of vehicles for special purpose.

Article 153 The food and drug administrative department and other departments under the State Council are responsible for making the training syllabus of professional training for food safety law enforcement officers, and the food and drug administrative department and other departments under the People’s Governments of provinces, autonomous regions and municipalities are responsible for organizing examination.

The law enforcement officers of the food and drug administrative department and other departments shall take no less than 40 class hours’ food safety professional training every year every person, and take examination, and those failing in the examination shall not be engaged in law enforcement of food safety.

Article 154 The food and drug administrative department under the People’s Government at the city and county level shall conduct daily supervision and inspection on food production and trading, and may, within its jurisdiction, select randomly food producers and traders and assign randomly supervision and inspection officers to implement inspection in other places and cross-place inspection.

The food and drug administrative department under the People’s Government at the city and county level will, according to the food safety annual supervision and management plan within its jurisdiction, organize and implement daily supervision and inspection and judge supervision and inspection results, make the inspection results to the public within 2 working days after the finish of daily supervision and inspection, and post the daily supervision and inspection results list at the conspicuous position of the production and trading sites.

Food producers and traders shall keep the posted daily supervision and inspection results list until the next daily supervision and inspection.

In case that the food producers and traders are judged basically compliant with relevant regulations upon daily supervision and inspection, the supervision and inspection officers shall raise, on the site, requirements of improvement of the problems found during supervision and inspection within a limited period. In case that the food producers and traders are judged incompliant with relevant regulations upon daily supervision and inspection and there is potential food safety risk, the food producers and traders shall immediately suspend related food production and trading activities. In case that the food safety risk is found during inspection, the food and drug administrative department may issue a warning letter to the food producers and traders and make it to the public.

For food, tools and equipment that there is the evidence of incompliance with the food safety standards or the evidence of existence of potential food safety risk and food, tools and equipment used for illegal production and trading, supervision and inspection officers can immediately seal up and detain and report to the food and drug administrative department at the same level within 24 hours to complete later the sealing-up and detention procedures.

Article 155 Under any of the following circumstances, the food and drug administrative department at or above the county level may conduct unannounced inspection, and supervise over the work of the food and drug administrative department at the lower level:

1) In case of suspected violation of food safety laws and regulations by the food producer and trader, which may cause serious hazard or great social impact;

2) In case of hidden danger existing in the food producer and trader, which may trigger regional, systematic food safety risks or cause serious hazard or great social impact;

3) In case of complaints and reports of serious violation behavior or serious food safety hidden danger existing in relevant food producer and trader;

4) Other circumstances necessary for organization of unannounced inspection.

Article 156 In case that the food and drug administrative department at or above the county level fails to timely identify and remove the systematic food safety risk occurred within its jurisdiction and caused by the food that there is already testing methods and testing items clearly regulated in the food safety standards, the People’s Government at the same level may conduct accountability conversation with the main person in charge.

Entrusted by the People’s Government of the same level, the food and drug administrative department may conduct accountability conversation with the main principal of the People’s Government at the lower level which fails to fulfill the legal responsibilities and to remove the regional major food safety hidden danger in time.

Article 157 The food and drug administrative department under the State Council shall organize the health administrative, agriculture administrative, quality supervisory and other departments under the State Council to strengthen food safety informatization construction, set up a unified food safety information platform, integrate food safety information resources and realize food safety information sharing.

Article 158 The food and drug administrative department under the State Council shall, in conjunction with the health administrative, quality supervisory, agriculture administrative and other departments under the State Council, prepare and release the national food safety status report every year.

Article 159 The State shall set up the food safety statistical investigation system. The food and drug administrative department under the State Council shall set up the food safety statistical indicators system and organize to carry out statistical investigation related to food safety, in conjunction with the statistics department under the State Council.

The food and drug administrative department under the People’s Government at or above the county level shall establish and improve the statistical investigation system and statistical indicators system of food safety within the administrative region, and organize to carry out statistical investigation related to food safety by reference to the national statistical investigation system and statistical indicators system of food safety, in conjunction with the competent statistics department at the same level.

The food producer and trader, industry association and other organization shall coordinate with the food and drug administrative department in carrying out statistical investigation of food safety under the law.

Article 160 The case inspection organ with juridical person qualification set up by the food and drug administrative department under the People’s Government at or above the county level may implement such supervisory management and law enforcement measures as on-site inspection, supervision and sampling inspection and case investigation in its own name.

Article 161 The organ sent by the food and drug administrative department may, in its name, conduct supervision and inspection and administrative guidance to the food producers and traders within the administrative region.

The organ sent by the food and drug administrative department may, in its name, make administrative punishment such as warning, confiscation of illegal gains, confiscation of illegal fund and articles and penalty. The specific amount of confiscation of illegal gains, confiscation of illegal fund and articles and penalty will be determined by the food and drug administrative department at the provincial level.

Article 162 In case of discovery of any of the following circumstances belonging to Article 123 and 124 of the Food Safety Law, the food and drug administrative department, quality supervisory and other departments under the People’s Government at or above the county level shall transfer clues and evidence related to the case to the public security organ within 3 working days:

1) Mixes poisonous, harmful non-edible food raw materials during food processing, sales, transportation, storage and other processes or uses poisonous, harmful non-edible food raw materials in food processing;

2) Uses and sells the meats of the poultry, livestock, animal, or aquatic that dies due to disease or any unknown reason, and their meat and meat products;

3) Produces and sells or uses the food that the State explicitly prohibits to produce or to sell due to special need, such as disease prevention etc.;

4) Formula food for infants and young children seriously incompliant with the food safety standards;

5) The content of pathogenic microorganism, pesticide residue, veterinary drug, heavy metal and other pollutants and other substances, which endanger the human health, exceeds the standard limit;

6) Other behaviors which are suspected to constitute crimes related to the food safety.

In case of suspicion of constituting a crime, the public security organ shall file a case for investigation in time under the law; in case of not constituting a crime and public security administrative punishment is needed under the law, the public security organ shall handle under the law; and in case that administrative penalty by the food and drug administrative department and other departments is need, related documents of the case shall be transferred such departments.

Article 163 The People’s Government at or above the county level will establish and improve the convergence mechanism between the food safety administrative law enforcement and the criminal justice, clarify such matters as clue notification, case transfer, evidence convergence, conference on details of a case, information sharing, information release, and supervision over inspection and handling, and coordinate and urge the investigation and handling of food safety violation criminal cases.

Article 164 In case of discovery of the need of food safety risk control during handling of criminal cases harmful to food safety, the public security organ shall take immediate measures to control food safety risk, such as control of the flows of involved products; in case of the need of assistance from the food and drug administrative and other departments, such departments shall provide active assistance.

In case that the food safety criminal case information to be published involves food safety risk control, the public security organ shall notify the food and drug administrative and other departments 3 working days in advance. When necessary, they can announce the information jointly and take effective measures to do well in interpretation and description.

Article 165 The food and drug administrative department under the State Council will formulate the measures for management of food safety judicial authentication, clarify the qualification conditions and determine the list of food safety judicial authentication institutions and authentication personnel, in conjunction with the judicial administrative department under the State Council.

Those who are entrusted to carry out food safety judicial authentication shall be chosen from the list of food safety judicial authentication institutions and authentication personnel.

Article 166 Where during the supervision and management and the law enforcement, the food and drug administrative, quality supervisory and other departments need the assistance from the public security organ under any of the following circumstances, the public security organ shall provide assistance:

1) Occurrence of violence against law or triggering the mass event;

2) Refuses, obstructs, impedes food safety supervision and law enforcement;

3) Destroys, conceals evidence or the party concerned runs away;

4) Requires assistance in taking evidence for serious difficult cases;

5) Other circumstances as provided by laws and regulations.

Article 167 Where the public security organ needs technical support and information verification from the food and drug administrative, quality supervisory and other departments in investigating the food safety criminal case, the food and drug administrative, quality supervisory and other departments shall provide assistance.

When the food and drug administrative, quality supervisory and other departments, during supervision and management, consult with public security organ for questions concerning suspicion of involvement of food safety criminal case investigation and evidence collection etc., such public security organ shall give timely response.

Article 168 For cases suspected of constituting a crime transferred by the food and drug administrative, agriculture administrative, quality supervisory and other departments, the public security organ shall examine within 3 days after receiving related materials transferred and make the decision of whether to file the case within 10 days.

If relevant violation involves such case as illegal addition of non-edible substance, illegal addition of drug, production and operation of the poultry and livestock died of disease, which seriously endangers the human health, the public security organ shall examine immediately.

Article 169 In case that the case does not constitute a crime and needs to be transferred to the public security organ and penalized by administrative detention, the food and drug administrative department at or above the county level shall transfer the case to the public security organ. The food and drug administrative department at or above the county level shall transfer the written case transfer and case-related materials to the public security organ at the same level within 3 days after making the decision of such transfer.

The public security organ shall accept according to the Regulations on Public Security Organ’s Procedures of Administrative Case Handling. In case that the public security organ considers upon investigation that the fact of the case’s violation of law is not clear and the evidence is not sufficient, it can inform, in a written form and within 3 days after accepting the case, the transferring department to transfer complimentary evidence; or investigate and collect evidence according to Regulations on Public Security Organ’s Procedures of Administrative Case Handling.

In case that the public security organ considers that the fact of the transferred case is clear and the evidence is true and sufficient and decides administrative detention, it shall copy the written decision to the transferring department within 3 days after making the decision. In case that the public security organ considers that the fact of the transferred case’s is not clear and the evidence is not sufficient and the conditions of administrative detention are not met, it shall inform the food and drug administrative department at or above the county level in written form and within 3 days after accepting the case, and provide the reason, and in the meantime, return the materials of the case.

Article 170 Evidence transferred by the food and drug administrative, quality supervisory, agriculture administrative and other departments to the public security organ may be used as the basis for administrative punishment by keeping the electronic data, photocopy of the written evidence attached with seal.

For the evidence transferred by the food and drug administrative, quality supervisory, agriculture administrative and other departments, the public security organ may use it as the evidence for the criminal case after verifying that it meets the criminal evidence standards.

Article 171 In case that, in respect of the food safety violations discovered, the public security organ finds that there is no facts of crime, or deems that no criminal responsibility needs to be affixed but the administrative detention shall be implemented under the law, it shall impose the penalty of administrative detention according to law; and but other administrative and legal responsibility shall be affixed under the law, it shall transfer the case to the food and drug administrative and other departments in time.

The public security organ shall at the same time transfer the photocopies of relevant evidence materials attached with seals to the food and drug administrative, quality supervisory, agriculture administrative and other departments. After verified by relevant department and deemed to meet the requirements for evidence of administrative law enforcement cases, it may be used as relevant evidence.

Article 172 For a case where the people’s court has given the judgment and where the food and drug administrative, quality supervisory, agriculture administrative and other departments shall impose such administrative punishment as revocation of the license but no punishment has been imposed, after verification, the food and drug administrative, quality supervisory, agriculture administrative and other departments may impose the administrative punishment under the law based on the facts and evidence determined in the judgment of the people’s court.

Article 173 In case that the law violation behaviors of food producers and traders are suspected of constituting a food safety crime, the food and drug administrative and other departments may impose administrative penalties such as ordered halting of production and business and revoking of license during case filing and investigation, review and prosecution and trial in order to prevent and control food safety risk.

 

Chapter 9 Legal Liabilities

Article 174 In case that the license of a food producer or a trader is expired, withdrawn, revoked or terminated, but the food producer or trader continues its production or sales, the food and drug administrative above the county level shall impose the penalty in reference to Clause 1 of Article 122 of Food Safety Law.

Article 175 In case that a food producer conducts food production beyond the licensed scope of categories or a food trader conducts food trading beyond the licensed scope of trading items, it shall be imposed the penalty in reference to Clause 1 of Article 122 of Food Safety Law.

Article 176 Under following circumstances, in case of not constituting a crime and belonging to “severe violation” in reference to Article 123 of Food Safety Law:

1) Anyone produces food in non-edible raw materials, produces or processes food with medicine added, produces foods by utilizing recycling food as raw materials, or the food listed above, or produces or sells the meats of the poultry, livestock, animal, or aquatic, that is killed by disease, poison, or any unknown reason, with the total value of the products more than one thousand RMB, or serious negative impact is caused;

2) Anyone adds any chemical substances other than food additives or any substances that may endanger people’s health into food, with the total value of the products more than two thousand RMB;

3) Anyone produces foods by utilizing recycling food as raw materials, with the total value of the products more than five thousand RMB;

4) Anyone produces or sells the meat product without inspection or that fails in inspection, or produces or sells the food that the State explicitly prohibits to produce or to sell due to special need, or produces or sells the staple food or dietary supplement that specially are targeted for sales to baby other group of people with special needs, whose nutrition formula does not conform the food safety standard, and had been in administrative penalty for any food safety law violation in past one year or the law violation behavior has lasted for over six months;

5) Other circumstance as prescribed by the laws or regulations;

For a producer with a circumstance prescribed by Article 123 of Food Safety Law, in case of incapability of conforming the total value of the products due to reasons such as incompleteness of production records, the total value of the products is subject to the total sum amount of the enterprise’s production and trading of the previous year.

Article 177 Under following circumstances, in case of not reaching the level of the criminal prosecution, the food and drug administrative, quality supervisory, agricultural administrative and other departments at or above the county level shall impose penalty in reference to Article 123 of Food Safety Law: 

1) Anyone violates relevant regulations to utilize the non-edible substance during its production, sales, storage, or transportation;

2) Anyone produces and/or processes the food or the food additives by utilizing the wasted or out-of-date food additives;

3) Anyone processes the food or food additive by utilizing the substances that may endanger people’s health in the way of soakage or fumigation, etc.;

4) Anyone passes non-edible chemical substances off as food additives;

5) Anyone adds illegally the chemical substances, or any other substances that may endanger people’s health, other than the drug, or food additives as raw materials;

6) Anyone directly cleans or sterilizes the vessels or appliances for food production or sales by utilizing non-edible detergent or sanitizer;

7) Any other circumstances as stipulated by the laws or the regulations;

In case of using prohibited substances like prohibited pesticides, veterinary drugs in the plantation or farming of edible agricultural products, penalty shall be given by agricultural administration departments of people’s government at county level or above according to the Clause 1.

Article 178 Under the following circumstance, the special food producer’s registration certificate of special food shall be revoked:

1) Produces the special food in the non-edible raw material, or add the chemical substances not included in the registered or filed formula or any other substances that may endanger people’s health;

2) Adds the drugs during the production process of the special food;

3) Produces or manages the production of the special food not in the product formula or technical specification that has been registered, and the values of the product is between ten thousand RMB to twenty thousand RMB;

4) Product the baby formula milk powder in sub-packing arrangement, or produce the health foods, food with special medical purpose or baby formula milk powder in the different brands by one enterprises, however, in same formula; and the value of the products is between ten thousand RMB to twenty thousand RMB;

5) Any other circumstances as stipulated by the laws or the regulations.

Article 179 In case of violation to Article 49 of this Implementation Rules as the food producer or trader fails to store out-of-date, bad or recycled food or food additive separately in a clearly marked site and register in record, or fails to timely destroy or conduct harmless treatment in other manners and make record, it shall be disposed in reference to Clause 1 of Article 124 of the Food Safety Law. In case that a food producer or trader sub-packs the food, change the original production date or extend the original shelf life, it shall be disposed in Clause 1 of Article 124 of the Food Safety Law.

In case that a food producer produces or a food trader sells a new type of food or food additive produced by a new food raw material that does not pass safety assessment yet, it shall be imposed in reference to Clause 1 of Article 124 of the Food Safety Law.

Article 180 Under any of the following circumstances, in case of not constituting a crime but the total value of products exceeds thirty thousand RMB and a food safety accident is caused, the food and drug administrative department under the People’s government at or above the county level shall impose the punishment under the criteria of “severe violation” in reference to Article 124 of Food Safety Law:

1) Produces or sells food or food additive that contains substances that may endanger human health, such as the pathogenic microorganism, pesticide residue, veterinary drug residue, biological toxin, heavy metal, to the extent that the content of such substance exceeds five times of the limit of the food safety standard;

2) Produces food or food additive with the food raw material or food additive beyond the shelf life;

3) Produces or sells the food with food additives utilized beyond the permitted scope;

4) Produces or sells food and food additives with spoilage, fact rancidity, mildew and rot, filthiness, mixture of foreign substance, adulteration or abnormalities in sensory properties;

5) Produces or sells food and food additives indicated with false production date or false shelf life or beyond the shelf life;

6) Utilizes new food raw materials to produce food, or produces new varieties of food additives, which has not passed safety assessment;

7) The food producer or trader refuses to recall or stop trading after the food and drug administrative department has ordered it to recall or stop trading;

8) Continues with production and trading after the food and drug administrative department and other departments have ordered it to rectify, and stop production and trading.

Article 181 Where, in respect of production, import and trading of quantitative intake edible special dosage form food, the label and description claims the health functions but it is not registered as the health food as provided, then the food and drug administrative department under the People’s Government at or above the county level will investigate and handle in accordance with Paragraph 1 of Article 124 of Food Safety Law. In case of suspicion of a crime, it will be transferred to the public security organ for handling under the law.

Article 182 Under any of the following circumstances, in case of not constituting a crime, the food and drug administrative under the People’s government at or above the county level shall impose the punishment in accordance with Paragraph 1 of Article 124 of Food Safety Law:

1) Violates the food safety management system, and food safety accidents have occurred;

2) Any enterprise producing formula milk powder for infants and young children violates Clause 1 or Clause 2 of Article 92 herein;

3) The food producer or trader fails to recall unsafe food within the specified time limit;

4) Produces or sells food or food additive that falsifies or uses other’s origin, factory name, factory address, accreditation mark or name etc. in production and trading;

5) The imported food trader cannot provide sanitary certificate or the certificate of inspection and quarantine for entry-exit goods, Chinese labels and inspection marks;

6) The special food production enterprise has not registered change or change of production license as provided in case of change in production conditions and technologies;

7) Produces or sells health food not compliant with the technical requirements;

8) Uses raw materials only for the health food to produce common food;

9) Other circumstances as provided by laws and regulations.

Article 183 Under any of the following circumstances with the products value over twenty thousand RMB, the food and drug administrative department under the People’s government at or above the county level shall impose the punishment under the criteria of “severe violation” in reference to Clause 1 of Article 125 of Food Safety Law:

1) Produces or sells food and food additives contaminated by packaging materials, containers or means of transport;

2) Produces or sells pre-packaged food and food additives without labels, or food and food additives whose label and description does not comply with the provisions of food safety laws and regulations;

3) Produces or sells genetically modified food without indication as provided;

4) The food producer or trader purchases or uses food raw materials, food additives, and food related products not conforming to food safety standards;

5) Other circumstances as provided by laws and regulations.

For the food or food additive produced or traded that its label or description has flaws but has no impact on food safety and will not mislead consumers, it is not of a “severe violation” circumstance included in Clause 1.

In case of trading pre-packed food without a production license, penalty shall be imposed in reference to Article 125 of Food Safety Law.

Under any of the following circumstances, the food and drug administrative department under the People’s government at or above the county level shall impose the punishment in accordance with Paragraph 1 of Article 125 of Food Safety Law:

Article 184 Under any of the following circumstances with occurrence of food safety accident involving more than 10 persons, the food and drug administrative department under the People’s government at or above the county level shall impose the punishment under the criteria of “severe violation” in reference to Clause 1 of Article 126 of Food Safety Law:

1) The food production and trading enterprise fails to set up the food safety management system as provided, or fails to equip or train and appraise food safety management staff as provided;

2) The food and food additives producer or trader fails to inspect the license and relevant certificates of incoming goods, or fails to set up and comply with the incoming goods inspection record, ex-factory inspection record and sales record system as provided;

3) The food production and trading enterprise fails to make the food safety accident handling plan;

4) The tableware, drink-ware and containers for ready-to-eat food are not cleaned or disinfected before use, or cleaning or disinfection is disqualified, or the catering service facilities and equipment are not maintained, cleaned and checked regularly as provided;

5) The food producer or trader arranges a person, who has not obtained the health certificate or who suffers from the disease impeding the food safety as provided by the health administrative department under the State Council, with work in contact with ready-to-eat food;

6) The food producer or trader fails to sell food as provided;

7) The health food production enterprise fails to file a record at the food and drug administrative department as provided, or fails to organize production according to the product formula, production technology and other technical requirements filed;

8) Any enterprise producing formula food for infants and young children fails to file a record of the food raw materials, food additives, product formula and label etc. at the food and drug administrative department, with the products value over twenty thousand RMB;

9) The special food production enterprise fails to set up the production quality management system and to operate it effectively as provided;

10) The food producer or trader fails to conduct inspection and assessment of the food safety situation regularly, or fails to handle as provided in case of change in production and operation conditions;

11) Schools, kindergartens, nursing institutions for the aged, and construction sites and other centralized dining units fail to fulfill the food safety management responsibility as provided;

12) The food production enterprise or catering service provider fails to formulate and implement production and trading process control requirements as provided;

13) Other circumstances as provided by laws and regulations.

Article 185 Under any of the following circumstances with violation to this Implementation Rules, the food and drug administrative department under the People’s government at or above the county level shall order to rectify and give a warning:

1) The food production and trading staffs fail to wear clean work clothes and hats as provided in producing or selling food, or fail to use non- toxic and clean sales tools to sell ready-to-eat food without packaging;

2) The food producer or trader fails to set up the food additives use and recording system;

3) The catering service provider uses tableware and drink-ware not cleaned and disinfected or fails to ask for and keep the qualified disinfection certificate in purchasing tableware and drink-ware from the tableware and drink-ware centralized disinfection service unit or entrusting with the disinfection.

Article 186 Under any of the following circumstances, the health administrative department shall impose the punishment on the centralized disinfection unit of tableware and drink-ware in accordance with Clause 1 of Article 126 of Food Safety Law:

1) Fails to set up sanitary administrators and fails to establish the sanitation management system or sanitation management file as provided;

2) Fails to carry on the production activities according to the requirements of hygienic practice;

3) Supervision and sampling inspection results have shown tableware and drink-ware to be disqualified.

Article 187 Under any of the following circumstances with violation to this Implementation Rules, the food and drug administrative department will order to rectify and give a warning; in case of refusal to rectify, it will impose a penalty of more than five thousand RMB but less than fifty thousand RMB:

1) The food trader fails to take such effective prevention measures as dust-proof and fly-proof for ready-to-eat food in bulk to be sold or uses packaging and label not conforming to the food safety requirements;

2) The food trader and the edible agricultural products seller fail to separately place the raw and fresh food from cooked products, with cross-contamination hidden danger existing;

3) The food storage service provider fails to keep the storage person’s identity certificate, license or business license photocopies as provided;

4) The food producer and trader fails to set up the food traceability system, resulting in inability to trace the food;

5) The third-party online food trading platform provider, food centralized trading market owner, food counter lessor and food exhibition organizer fail to establish the food safety accident handling plan;

6) The containers and packaging materials for food raw materials, semi- finished products and finished products are in direct contact with the floor or unclean articles;

7) Water from self-provided water source does not conform to the drinking water sanitary standards as provided by the State;

8) The catering service provider fails to be equipped with effective tableware and drink-ware disinfection and sanitation facilities as required;

9) Such cleaning and disinfection products as detergent and disinfectant used in the food production and trading process do not conform to requirements.

Article 188 Where the food produced or traded by the food producer and trader conforms to the food safety standards, but does not conform to the enterprise standards indicated, the food and drug administrative department may order the food producer and trader to rectify and give a warning. The food producer or trader that refuses to rectify shall be penalized below two thousand RMB. Where the consumer demands return or compensation, the food producer and trader shall be liable for civil responsibility in accordance with laws and regulations.

Article 189 Under any of the following circumstances, the food and drug administrative department under the People’s Government at or above the county level may impose the punishment on the third-party online food trading platform provider in accordance with Clause 1 of Article 131 of Food Safety Law:

1) Fails to provide as required such materials as registration information and trading data of the food and food additives trader who uses the platform;

2) Arbitrarily transfers, tampers with, falsifies, or deletes the trading data of the food and food additives trader who uses the platform.

Article 190 In case that the third-party online food trading platform provider fails to conduct real-name registration or license review to the food producers and traders on the platform or fails to perform duties of reporting and suspending to provide online trading platform service as provided, under any of the following circumstances, the food and drug administrative department at or above the county level may order such provider to suspend operations of part or all of the food categories:

1) Results in death or serious personal injury;

2) Occurrence of relatively large or larger food safety accidents;

3) Occurrence of relatively severe foodborne disease;

4) Damages legal consumer rights and interests and results in severe negative social impact;

5) Results in other severe consequences.

Article 191 Where the food producer and trader illegally disposes of the articles sealed up or detained by the food and drug administrative department in such a manner as concealment, transfer, utilization, sale or destruction, the food and drug administrative department under the People’s Government at or above the county level and other departments shall confiscate the illegal gains, impose a penalty equivalent to more than ten times but less than twenty times of the value of the concealed, transferred, utilized, sold or destroyed goods and revoke the license; in case of constituting a crime, the criminal responsibilities shall be affixed under the law.

Article 192 “Refuses, obstructs or intervenes” as provided in Clause 1 of Article 133 of Food Safety Law includes the following circumstances:

1) Delays or avoids supervision and inspection, investigation and handling by the on-site law enforcement officers;

2) Prohibits the on-site law enforcement officers from entering the production, trading and storage premises;

3) Fails to provide relevant contracts, bills, account books and electronic data as required without a justified reason;

4) Other circumstances as provided by laws and regulations.

Article 193 Under any of the following circumstances, punishment shall be imposed under the criteria of “severe violation” in reference to Clause 1 of Article 133 of Food Safety Law:

1) Refuses, obstructs, or impedes food safety supervision, management and law enforcement in such a manner as assaulting, insulting, abusing or threatening;

2) Destroys, conceals the evidence or the party concerned runs away and hides;

3) Retaliates against the law enforcement officer, reporter and witness.

Article 194 In case of qualification penalty imposed in accordance with Article 135, Article 137, Clause 2 of Article 138, and Clause 1 of Article 139 of Food Safety Law, the food and drug administrative, quality supervisory and other departments under the State Council shall summarize and announce on their websites the names, ID Card numbers and relevant information of the executive in charge being directly responsible, and other persons being directly responsible. The qualification penalty shall be conducted according to the Administrative Penalty Law.

In case that the administrative license applicant conceals relevant information or provides false materials to apply for the administrative license, the administrative organ will not accept or reject the administrative license and give a warning, and the applicant shall not re-apply for such administrative license within one year.

In case that the licensee has obtained the administrative license in such an unjustified manner as cheating and bribery, the administrative organ shall revoke the related administrative license and impose the administrative punishment under the law, and the applicant shall not re-apply for such administrative license within three years; in case of constituting a crime, the criminal responsibilities shall be affixed under the law.

Article 195 In case that the food producer or trader falsifies and alters the registration certificate, food production and trading license, label, description, inspection report, inspection & quarantine certificate, authentication certificate and provides false materials in supervision and inspection, the food and drug administrative department under the People’s Government at or above the county level will confiscate the illegal gains, and impose a penalty of more than fifty thousand RMB but less than one hundred thousand RMB and the license shall be revoked in case of the food production and trading license; in case of constituting a crime, the criminal responsibilities shall be affixed under the law.

Article 196 For the food that shall be confiscated under the law, the food and drug administrative department may order the food producer or trader to take measures such as harmless treatment and destroy and apply supervised destroy if needed.

The food producer or trader that does not execute the incoming goods inspection recording system and as a consequence, the food incompliant with the food safety standards is not traceable or the food safety violation behavior investigation and penalty cannot continue, a severer punishment shall be given.

Article 197 Under any of the following circumstances with violation to food safety laws and regulations, the food producer and trader shall be given a severer punishment:

1) Causes serious damage or large social impacts;

2) Causes systematic and regional food safety risks;

3) Illegally produces and trades special food;

4) Causes food safety accidents;

5) Subjectively intentional misconduct or gross negligence;

6) Refuses, avoids supervision and inspection or violently threatens and obstructs the law enforcement officer to execute public duties;

7) Provides fake evidence or destroy the evidence;

8) Other circumstances where a severer punishment shall be imposed under the law.

In case that the same violation behavior has violated several provisions of food safety laws and regulations, the punishment shall be imposed in accordance with the provision for severer punishment.

Article 198 Under any of the following circumstances, the food producer and trader shall be given a lighter or mitigated punishment under the law:

1) Have no intentional misconduct or gross negligence subjectively, and the circumstances of violation are relatively minor with a relatively small products value, and no harmful consequences caused;

2) Be initiative in reporting to the food and drug administrative department, with no harmful consequences caused;

3) Be initiative in recalling unsafe food, with no harmful consequences caused, and has taken effective measures to mitigate or eliminate food safety risks;

4) Reports and cooperates with the administrative department in investigating and handling other unknown violations, with major meritorious service;

5) Actively take effective measures to protect legal consumer rights and interests and reduce or remove damaging consequences to consumers;

6) Other circumstances where a lighter or mitigated punishment shall be imposed under the law.

Administrative penalty will not be imposed in case of minor violation and rectification in time, with no harmful consequences caused.

Article 199 In case of any of the following circumstances of the inspection institutions with violation to this Implementation Rules, the food and drug administrative department may make it to the society and shall not entrust such inspection institution to undertake sampling inspection tasks.

1) Illegally replaces samples, falsifies inspection data or issues fake inspection reports;

2) Utilize the convenience due to the sampling inspection work to seek unjust benefits;

3) Violates the regulations and notices the food producer or trader for sampling inspection in advance;

4) Arbitrarily publish food safety sampling inspection information;

5) Fails to report inspection reports as disqualified according to the regulated time frame and procedures;

6) Other law violation behaviors.

The re-inspection institutions with any of the first, second and fourth circumstances listed in Claus 1 of this Article, the relevant departments shall remove such re-inspection institutions from the directory of re-inspection institutions.

In case that the food inspection institutions and inspection personnel illegally change the samples, falsify inspection data or issue fake inspection reports, the inspection results are invalid.

Article 200 With violation to this Implementation Rules, in case that a medical institution and its working staffs fail to report the food safety accident information as provided, or the disease prevention and control institution fails to make the epidemiological investigation report as required or fails to report within the prescribed time limit, then the health administrative and other departments under the People’s Government at or above the county level shall order them to rectify under the law; in case of refusal to rectify, a penalty of more than five thousand RMB but less than fifty thousand RMB will be imposed.

Article 201 Under any of the following circumstances, the advertisement supervisory management department under the People’s Government at or above the county level shall order the accountable advertiser, advertising agent, and advertising publisher to stop publishing, order the advertiser to remove the impact within the relevant scope, confiscate the advertising fees under the law, and a penalty of more than one time but less than three times of the advertising fees shall be fined, and in case that the advertising fees are not computable or obviously low, a penalty of one hundred thousand RMB but less than two hundred thousand RMB will be fined; If severe, a penalty of more than 3 times but less than 5 times of the advertising fees will be fined, in case that the advertising fees are not computable or obviously low, a penalty of two hundred thousand RMB but less than one million RMB will be fined; the business license can be revoked and the food and drug administrative department under the People’s Government at or above the province level will decide to suspend sale of the food and food additives, and announce to the public. In case of continuous sale, the food and drug administrative department under the People’s Government at or above the county level will confiscate the illegal gains and the food and food additives illegally sold, and impose a penalty of more than twenty thousand RMB but less than fifty thousand RMB together:

1) The advertisement is not approved after examination and approval;

2) The advertisement approval No. is canceled or revoked;

3) Relevant department of the State has ordered it to stop production and sale;

4) The advertisement is determined to be disqualified after re- examination by the food and drug administrative departments under the People’s Governments of provinces, autonomous regions and municipalities where the advertisement is published;

5) Arbitrarily modifies or tampers with the examined and approved advertisement;

6) The advertisement includes contents prohibited from publishing by laws and regulations.

Article 202 In case of false publicity and sale of the health food, the formula food for special medical purpose and other food via the Internet, telephone, TV, lecture, and conference etc., if severe, the food and drug administrative department under the People’s Government at or above the county level will decide to suspend the sales of such food and make it to the public; in case of continued sales of such food, the food and drug administrative department under the People’s Government at or above the county level will confiscate the illegal gains and the food in illegal sales, and impose a penalty of more than twenty thousand RMB but less than fifty thousand RMB  together.

In case that a unit or individual who has known of the violation behavior provided in the preceding paragraph, but still provides premises or other conditions, the food and drug administrative department under the People’s Government at or above the county level will order it to stop violation, confiscate the illegal gains, and impose a penalty of more than fifty thousand RMB but less than one hundred thousand RMB together; in case of impairment of the consumer’s legitimate rights and interests, it shall be held jointly and severally liable with the food and food additives producer and trader.

Article 203 In case of intentional violation or gross negligence of working staffs of the food and drug administrative, quality supervisory, agriculture administrative, health administrative and other departments under the People’s Government at or above the county level, the supervisory organ or appointment and removal organ at the same level will affix the administrative liabilities against the working staff of the department pursuant to relevant provisions. In case of constituting a crime, it will be transferred to the judicial organ for handling.

The People’s Government and departments such as finance and budgeting departments at or above the county level do not perform the related responsibilities and do not provide effective supports such as financial, personnel and technical supports, which results in regional food safety risks, the obligations of related staff shall be affixed according to the relevant regulations of the Food Safety Law.

In case of the occurrence of major food safety violation case and food safety accident due to reasons attributable to the food producer and trader, if there is evidence proving that the working staffs of the food and drug administrative, quality supervisory, agriculture administrative, health administrative and other departments have fulfilled food safety supervisory management responsibilities under the law, they shall be exempt from administrative liabilities.

 

Chapter 10 Supplementary Provisions

Article 204 Meanings of the following terms in the Rules are as follows:

Edible agricultural products refer to plants, animals, microorganisms and their products, which are obtained in planting, cultivating, picking, fishing, facility agriculture, biological engineering and other agricultural activities, and formed by primary processing such as sorting, peeling, husking, crushing, cleaning, cutting, freezing, waxing, grading and packaging, whose basic natural characteristics and chemical properties have not changed.

Catering service refers to service activity of providing food to consumers directly through instant making and processing.

Food safety risk assessment refers to scientific assessment of the bad impacts which may cause to the human health by the biological properties, chemical properties and physical properties in food, food additives and food related products, including hazard identification, hazard characterization, exposure assessment and risk characterization etc.

Food safety risk exchange refers to the process where the food safety interested parties exchange information and opinions on food safety risks, risk related factors and risk perception involved in relevant work.

Health food refers to food which is claimed to have the health functions or aims at supplementing vitamins, minerals and other nutrients, able to adjust physiological functions, not for the purpose of treating disease, having special function components, and suitable for special group of people to take with specified intake amount.

Food in bulk refers to food without quantitative pre-packaging, which needs to be sold quantitatively, including food without packaging and non- quantitative packaging.

First time import of the health food refers to the health food not in the same formula from the same enterprise in the same country.

Food fast testing method refers to testing technique and products applicable to testing of food safety related items, characterized by fastness, simplicity and sensitivity.

Food safety professional technical personnel refers to personnel with study and practice background in food, biology, chemistry, medicine and other food safety related natural sciences specialties, having professional knowledge and technology in food biological, chemical, and physical properties, food production technologies, food production facilities and equipment characteristics, food contamination sources and food safety risk control requirements, and food safety inspection technologies, and being able to identify and control relevant food safety risks.

Quantitative intake edible special dosage form food refers to food in the special dosage form such as capsule, oral liquid, tablet, granule, and pill, which needs to be taken quantitatively or with daily prescribed intake amount.

Toxic and harmful non-food raw materials refers to substance prohibited by laws and regulations from being added or used in food production and trading; substances on the List of Non-edible Food Substances Likely to be Illegally Added into Food and List of Substances Likely to be Illegally Added into health Food announced by relevant department under the State Council; pesticides, veterinary drug and other toxic and harmful substances prohibited from using by announcement of relevant department under the State Council; other substances which endanger the human health.

Flaw in label and description of the food and food additives means circumstances of word space, font size, punctuation marks, simplified and traditional forms, and rounding interval etc. in label and description of food and food additive, which is not non-conforming to relevant requirements, and which will not affect food safety, nor mislead food safety consumption of consumers.

Food sub-packing refers to the food production behavior where the food producer or trader divides large packaged food into small ones, containing smaller amount of pre-packaged food through certain technique control, under the precondition that the food safety is not affected for the pre- packaged food which will be directly released on the market. Large packaged food being sold off piecemeal and not being processed into pre- packaged food at the food trading stage will not fall into food sub-packing.

Unannounced inspection refers to sudden supervision and inspection carried out by the food and drug administrative departments to the corresponding persons under their administration without informing such persons in advance.

Recalled food refers to the food that has been sold but is recalled by the food producer or trader or is returned due to reasons such as violation to laws and regulations or food safety standards or beyond the shelf life, but excluding the food with flow in its label or description.

Products value means the total amount of the market price of the food, food additives, and food related products illegally produced or traded by the producer and trader, or the edible agricultural products illegally traded. Among them, the raw materials and food additives are calculated according to the purchase price, semi-finished products are calculated according to the raw materials price plus other costs, and finished products are calculated according to the sale price. The sale price of a single product produced shall be calculated at the unit price indicated in sale, and the sale price of a single product sold shall be calculated at the unit price indicated on the goods label by the seller. In case of no price marked by the producer and trader, it shall be calculated at the average unit price of the market retail price in the region when the product is investigated and handled.

Illegal gains mean all the operating income from conducting the illegal production and sales of food, food additives and food-related products. In case of no intentional violation by the food producer or trader, who has fulfilled such legal obligations as incoming inspection, and asking for certificates and bills, and has evidence proving that it is not aware that the raw materials purchased or food traded does not conform to the food safety standards, with no harmful consequences caused. In calculating the amount of illegal gains, the purchase price of the food sold or raw materials shall be deducted.

Article 205 The filing mentioned herein means the process of administrative counterpart’s registration, record-filing, announcement and keeping on file for future reference of relevant materials at relevant department pursuant to pertinent provisions.

For filing of enterprise standard, and relevant filings of health food and formula food for infants and young children, relevant departments shall not grant administrative license in a disguised form through review, determination, examination and approval etc.

In case of no explicit provisions on food additives in the Rules, the provisions of the Rules on relevant food shall apply, mutatis mutandis.

Article 206 The frontier ports named in the Rules mean the international gateways for entry or exit of personnel, luggage, goods, containers, means of transport, articles and postal parcels. The food and drug administrative department is responsible food safety administration in areas other than frontier ports as ports, airports, stations, ground boundaries, and boundary rivers.

Article 207 In order to ensure work requirements of special food registration application, technical evaluation fee and inspection and validation fee shall be paid for application for registration of health food, formula food for special medical purpose, and formula milk powder products for infants and young children. The charging standard will be formulated by the financial department and competent pricing department under the State Council in conjunction with the food and drug administrative department under the State Council.

Article 208 The Rules shall become effective as of DD-MM-YY.