Requesting the specific content of the Implementing Regulations of the Food Safety Law of the People's Republic of China and the People's Republic of China

On September 1, 2015, the State Food and Drug Administration promulgated and implemented the "Food Safety Law". On December 9, the State Food and Drug Administration solicited comments on the draft implementation regulations, with the following contents:

State Food and Drug Administration (December 9, 2015)

No. Chapter General Provisions

Article 1 These regulations are formulated in accordance with the Food Safety Law of the People's Republic of China (hereinafter referred to as the Food Safety Law).

Article 2 Food producers and traders shall engage in production and business activities in accordance with laws, regulations and food safety standards, take effective measures to prevent and control food safety risks, prevent and reduce food safety hazards, and ensure food safety.

Article 3 The Food Safety Committee of the State Council is responsible for researching, deploying, coordinating and guiding national food safety work, formulating national food safety strategies, proposing major food safety policies and measures, analyzing and solving major food safety issues, and supervising the implementation of food safety responsibilities. .

The Office of the Food Safety Commission of the State Council is responsible for the daily work of the committee, organizing the formulation of national food safety plans, coordinating and handling major issues in the formulation and implementation of food safety laws, regulations and standards, and supervising and inspecting the implementation of major national food safety decisions and deployments. Evaluate and assess the performance of food safety responsibilities by provincial people's governments and relevant departments of the State Council, and guide the handling of major food safety accidents.

Article 4 Local people’s governments at or above the county level shall be responsible for territorial management of food safety in their own administrative regions, improve food safety supervision and management systems and mechanisms, strengthen food safety governance systems and governance capacity building, and ensure food safety supervision personnel , funds, technical support, etc. are put in place, and responsibility is taken for regional food safety risks and major food safety accidents.

The responsibilities of the food safety committees of local people's governments at or above the county level and their offices shall be determined by local people's governments at all levels with reference to the responsibilities of the Food Safety Committee of the State Council and its offices.

Article 5 The food and drug supervision and administration department of the people's government at the county level may, based on the area of ​​jurisdiction, population, supervision objects, etc., set up food and drug supervision and administration agencies in towns or specific areas to perform corresponding duties in accordance with the law.

Article 6 Township people's governments and sub-district offices are responsible for the investigation of food safety hazards, information reporting, law enforcement assistance, publicity and education, etc. in their respective regions, and take effective measures to strengthen food safety management.

Township people’s governments and sub-district offices should support food and drug regulatory agencies to carry out supervision and management work in accordance with the law.

Township people’s governments and sub-district offices should establish teams of food safety coordinators or information officers to assist the food and drug supervision and administration departments in food safety work.

Article 7: The state shall incorporate food safety knowledge into national quality education and primary and secondary education curricula, strengthen the popularization of food safety scientific knowledge and legal knowledge, and improve the food safety awareness of the whole society.

Article 8 People’s governments at or above the county level shall establish special projects and funds for food safety awards to provide support for food safety risk monitoring and assessment, standard formulation, supervision and inspection, major event guarantees, emergency response, and case investigation and handling. As well as units and individuals who have made outstanding contributions in scientific research, publicity and education, social governance and other work, commend and reward them.

Chapter 2 Food Safety Risk Monitoring and Assessment

Article 9 The health administration department of the State Council, together with the food and drug administration, quality supervision, agricultural administration and other departments of the State Council, formulate and publish national food safety regulations Risk monitoring plan.

The health administrative departments of provinces, autonomous regions, and municipalities directly under the Central Government shall submit their local food safety risk monitoring plans to the health administrative department of the State Council for filing. The health administrative department of the State Council shall notify the food and drug administration, quality supervision, agricultural administration and other departments of the State Council of the filing status.

Article 10 The national food safety risk monitoring plan shall focus on monitoring the following foods and related harmful factors for which food safety standards have not yet been formulated:

(1) High risk level, circulation Wide range and large consumption;

(2) Easy to cause health effects on infants and other specific groups of people;

(3) Consumers have reported many problems;< /p>

(4) Causing food safety accidents overseas.

Foods for which food safety standards have been formulated should be supervised and inspected by the food and drug supervision and administration, quality supervision, agricultural administration and other departments. The health administrative department of the State Council shall promptly conduct follow-up evaluation and revision of national food safety standards based on the results of food safety risk monitoring and supervisory sampling inspections.

Article 11 The health administration, food and drug administration, quality supervision, agricultural administration and other departments of the State Council shall carry out food safety risk monitoring within the scope of their respective responsibilities in accordance with the national food safety risk monitoring plan.

The health administration department of the State Council is responsible for organizing and carrying out risk monitoring of food-borne diseases, food contamination, and harmful factors in food; the food and drug regulatory department of the State Council is responsible for organizing and carrying out risk monitoring of harmful factors in food production and sales, catering services, etc. The State Council’s quality supervision department is responsible for organizing the risk monitoring of harmful factors in food-related products and imported and exported food; the State Council’s agricultural administrative department is responsible for organizing the risk monitoring of pesticides, veterinary drug residues and other pollutants in the planting and breeding of edible agricultural products; the State Council The grain department is responsible for organizing and carrying out risk monitoring of heavy metals and other pollutants in raw grains.

Relevant departments should organize consultations on the problems discovered during their respective food risk monitoring and take effective measures to prevent and control food safety risks.

Article 12 Health administration, food and drug supervision and management, quality supervision, agricultural administration and other departments should make full use of technical institutions with corresponding capabilities and social third-party technical institutions to carry out food safety risk monitoring work.

Technical institutions responsible for food safety risk monitoring shall carry out their work in accordance with the food safety risk monitoring plan, monitoring plan and work specifications to ensure that the monitoring data is true, accurate and complete.

Article 13 The health administrative department of the provincial people's government shall, in conjunction with the food and drug administration, quality supervision, agricultural administration and other departments at the same level, establish a food safety risk monitoring data notification and consultation mechanism to summarize and analyze risks Monitor data, analyze and judge food safety risks, form monthly, quarterly, half-year, and annual analysis reports on food safety risk monitoring, and report to the provincial people's government and the State Council's health administration, food and drug supervision and management, quality supervision, and agricultural administration within 7 working days and other departments. If it is discovered that there may be a greater food safety risk, it should be reported within 2 working days.

Article 14 If the health administrative department discovers that there may be potential food safety hazards during food safety risk monitoring work, it shall promptly conduct a food safety risk assessment; if it discovers that there are illegal acts in food production and operation, it shall notify the Food and Drug Administration Supervision and management departments.

If the food and drug supervision and administration departments find that a food safety risk assessment needs to be carried out during food safety investigations, they shall promptly notify the health administrative department, and the health administrative department shall promptly conduct a food safety risk assessment and report the assessment results Notify the food and drug supervision and administration departments.

Article 15 If the food safety risk monitoring results indicate that there is a food safety risk, the food and drug supervision and administration department may notify relevant food producers and operators based on risk control needs. Food producers and operators should immediately take measures to conduct risk inspections, suspend production, sales and use, recall foods with potential food safety hazards, and promptly report to the local food and drug regulatory authorities at or above the county level.

Article 16 Risk monitoring and risk assessment of the quality and safety of edible agricultural products shall be carried out by the agricultural administrative departments of the people's governments at or above the county level in conjunction with the health administration, food and drug supervision and administration departments at the same level.

Article 17 The health administration department of the State Council shall, in conjunction with the food and drug supervision and administration departments of the State Council, formulate a food safety risk assessment work plan, build and manage a national food safety risk assessment basic database, and organize the development of basic food safety risk assessment data collection and methodological research.

The health administration, food and drug administration, quality supervision, agricultural administration and other departments of the State Council should establish a food safety risk assessment information exchange mechanism to share risk assessment data and information.

National food safety risk assessment agencies are encouraged to entrust technical institutions with corresponding capabilities to undertake national food safety risk assessment tasks.

Article 18 The National Food Safety Risk Assessment Expert Committee is established and managed by the health administration department of the State Council in conjunction with the food and drug administration, quality supervision, agricultural administration and other departments of the State Council.

The National Food Safety Risk Assessment Expert Committee is responsible for formulating technical methods and requirements for food safety risk assessment, approving food safety risk assessment results reports, and interpreting and communicating food safety risk assessment results.

Article 19 If the food and drug supervision and administration, quality supervision, agricultural administration and other departments of the State Council discover the need to evaluate the safety of pesticides, fertilizers, veterinary drugs, feed and feed additives during supervision and management work, Suggestions on risk assessment shall be made to the National Agricultural Products Safety Risk Assessment Expert Committee, which shall conduct risk assessments in a timely manner and notify the relevant departments of the State Council of the assessment results.

The safety assessment of pesticides, fertilizers, veterinary drugs, feeds and feed additives should be conducted by relevant review committees in conjunction with the National Food Safety Risk Assessment Expert Committee.

Article 20 The health administrative department of the State Council shall, based on the needs of food safety risk assessment work, organize and carry out basic data surveys on food consumption status, environmental factors affecting food safety, total dietary research, public awareness, etc. Work.

Article 21 The food and drug regulatory authorities of the people’s governments at or above the provincial level, together with relevant departments at the same level, shall conduct supervision and management based on food safety risk monitoring, risk assessment, daily supervision, supervision and sampling, case investigation and special rectification, etc. Comprehensive evaluation of information and public opinion information, and for foods that are evaluated to have higher safety risks, food safety risk warning information should be published in a timely manner in accordance with their duties.

Article 22 The state establishes a food safety risk communication system. Food safety risk communication work should be scientific, objective, open and transparent, timely and effective, with multi-party participation, communication and consultation.

The state encourages food producers and operators, food safety-related technical institutions, food-related industry associations, consumer associations, news media, etc. to participate in food safety risk communication work and promote social governance of food safety.

Article 23 The Food and Drug Administration Department of the State Council and other relevant departments shall formulate food safety risk communication work standards and establish·

Article 24 Food and Drug Administration Department of the State Council and other relevant departments should establish a food safety risk communication advisory committee composed of experts in food, public health, clinical medicine, news and communication, etc., to provide consultation suggestions for food safety risk communication and participate in risk communication. As needed, the Food Safety Risk Communication Advisory Committee may solicit opinions from social organizations, food producers and operators, consumers, news media, etc. on risk communication matters, and invite representatives from relevant parties to participate in risk communication work.

Chapter 3 Food Safety Standards

Article 25 The health administrative department of the State Council shall formulate a plan for national food safety standards in conjunction with the food and drug administration, quality supervision, agricultural administration and other departments of the State Council. and its annual implementation plan. The formulation of national food safety standard plans and annual implementation plans should be publicly solicited for opinions.

Article 26 The health administration department of the State Council, together with the food and drug supervision and administration department of the State Council, organizes a national food safety standards review committee to formulate food safety standard management measures and organize project establishment, drafting, review, and promulgation of national food safety standards. standard.

The health administration department of the State Council, together with the food and drug administration department of the State Council, selects units with corresponding technical capabilities to draft national food safety standards.

Encourage scientific research institutions, technical institutions, academic groups, industry associations and other units to jointly draft draft national standards for food safety.

Article 27 The health administrative department of the State Council shall, in conjunction with the food and drug regulatory department of the State Council, expedite the formulation of national food safety standards for the variety, scope and amount of food additives used in catering services, as well as urgently needed food safety standards for food safety supervision and law enforcement. national food safety standards.

Article 28 The health administrative departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall, in conjunction with the food and drug regulatory authorities at the same level, formulate local food safety standard plans and implementation plans, and organize project establishment, drafting, review, and promulgation Local standards for food safety.

Health foods, formula foods for special medical purposes, formula foods for infants and young children, food additives, food-related products and new food raw materials are not allowed to formulate local food safety standards.

Article 29 The health administrative departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall report to the health administrative department of the State Council for filing within 30 working days from the date of promulgation of local food safety standards.

If the health administrative department of the State Council discovers that the registered local food safety standards violate laws, regulations and national food safety standards, it shall promptly correct them.

After the national food safety standards are announced, the corresponding local food safety standards will be abolished. The health administrative departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall promptly announce the abolition status.

Article 30 Enterprise standards shall be implemented after approval by the enterprise’s legal representative or principal person in charge. Food production enterprises shall be responsible for the reported enterprise standards.

Chapter 4 Food Production and Operation

Section 1 General Provisions

Article 31 The food and drug regulatory department of the State Council shall, based on the level of economic and social development, Formulate food production and operation management regulations based on factors such as production and operation scale, technical conditions, and food safety requirements.

Food producers and traders shall carry out production and business activities in accordance with food production and business management regulations.

Article 32 Food producers and operators and operators specializing in food transportation shall not purchase, use, store or transport non-edible substances that are expressly prohibited by relevant departments in the process of production and operation; they shall not use recycled Food additives processed foods or food additives.

It is prohibited to illegally add drugs, chemical substances other than food additive raw materials, and other substances that may harm human health in food additives.

Article 33 Enterprises specializing in the production of food semi-finished products, extracts, etc. shall obtain a food production license in accordance with the law; those selling food through telephone calls, conferences, lectures, etc. shall obtain a food business license in accordance with the law.

Food producers who have obtained a food production license do not need to obtain a food business license to sell the food they produce at their production sites; catering service providers who have obtained a food business license sell their production and processing at their catering service sites Food does not require a food production license.

Article 34 If a food producer or operator entrusts the production of food or food additives, the entrusted party shall obtain a food production license. The entrusting party shall bear legal responsibility for the safety of the food produced under entrustment. The entrusted party shall be responsible for its production behavior. Responsible.

When entrusting the production of food, both parties shall sign a written agreement to clarify the rights and obligations of both parties in terms of food safety.

Article 35 The health administrative department of the State Council shall, together with relevant departments, regularly publish a catalog of new food raw materials, new varieties of food additives and new varieties of food-related products, as well as the implemented national food safety standards, and review their safety standards. Conduct follow-up evaluation.

Article 36 The safety assessment materials for new food raw materials, new food additive varieties and new food-related product varieties submitted by applicants to the health administration department of the State Council shall include technical information provided by relevant industry organizations. There are indeed necessary certification materials, safety assessment opinions provided by professional technical institutions, development status of relevant standards and their standard texts, etc.

Article 37 Substances included in the catalog of substances that are both food and traditional Chinese medicinal materials according to tradition shall meet the following requirements at the same time:

(1) Have a history of consumption in our country and have not Any acute, subacute, chronic or other potential harm to human health is found;

(2) There are records of consumption in ancient books, but no records of toxicity are found;

(3) Included in the national drug standards;

(4) It can maintain the sustainability of the development of relevant species resources, will not cause adverse effects on wild medicinal resources and the ecological environment, and does not belong to the list of national key protected wild animals and Wild animals and plants listed in the national list of key protected wild plants;

(5) Meet the requirements of relevant laws and regulations.

Article 38 Food producers and traders shall record and preserve information on purchase, production, processing, packaging, transportation, storage, sales, inspection, recall and cessation of operations. The recorded information shall be true and accurate. Accurate and complete, achieving food traceability.

Section 2 Production and Operation Process Control

Article 39 The legal representative or principal person in charge of a food production and operation enterprise shall be fully responsible for the food safety of the unit and shall establish and implement the Food safety accountability.

Article 40 Food safety management personnel assist the legal representative or principal person in charge of food production and operation enterprises to assume food safety management responsibilities.

The legal representative or principal person in charge of a food production enterprise may authorize food safety managers to assume the following food safety management responsibilities:

(1) Responsible for the management of supplier selection;

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(2) Responsible for the management of incoming inspection and factory inspection, and responsible for the authenticity of records;

(3) Organize and carry out corporate food safety self-inspections, and verify the authenticity of self-inspection reports

(4) Supervise the implementation of the control system for food production and operation processes;

(5) Organize and implement food recalls;

(6) Fulfill food safety requirements Safety incident reporting obligations;

(7) Other obligations stipulated in laws and regulations.

Article 41 Food safety management personnel should have food safety laws and regulations, food safety standards, food safety professional knowledge and food safety management capabilities that are suitable for their positions.

The food and drug regulatory department of the State Council shall formulate assessment and management measures for food safety management personnel of food production and operation enterprises.

Article 42 Food producers and traders shall inspect and evaluate the food safety status of their units by themselves or by entrusting third-party professional institutions or professionals to do so.

Article 43 If the food produced and traded by food producers and operators needs to be irradiated, they shall entrust a unit with irradiation qualifications to carry out the inspection and conduct inspections in accordance with relevant standards for irradiated food.

Food producers and operators shall promptly report the processing of food by the irradiation device unit and the use of irradiated food raw materials to the food and drug supervision and administration department of the local county-level people's government.

Article 44 Food producers and operators shall establish a food safety information disclosure system and promptly report food production and operation licenses, food enterprise standards, risk classification labels, inspection and inspection results, food recalls and suspension of operations, and Disclosure of qualified food disposal and other information to the public.

Article 45 The food and drug supervision and administration departments of the people's governments at or above the provincial level shall, based on the food safety risk status and food safety supervision and management needs, regulate food production and operation enterprises of larger scale and above, as well as meat products and dairy products. Promote good production practice requirements and implement hazard analysis and critical control point systems in other food production and operation enterprises.

Article 46 Producers of food, food additives and food-related products shall conduct self-inspection or entrust inspection of the food, food additives and food-related products they produce in accordance with food safety standards.

If the shelf life of food is less than the period required for routine inspection, rapid detection methods can be used.

Article 47 Food operators who sell health foods, formula foods for special medical purposes, and infant formula milk powder that are subject to registration management shall inspect the product registration certificate and check the stated content and product labels. Check whether the marked contents are consistent and keep a copy of the registration certificate.

Article 48 Food producers and operators shall register and keep records of food, food additives, and food-related products that have exceeded the shelf life, have deteriorated, or have been recycled, store them separately in clearly marked places, and promptly dispose of them. Destroy or dispose of it in other harmless ways, and keep relevant records.

Article 49 If food producers and operators entrust warehousing, logistics and distribution enterprises to store and transport food, they shall review the food safety assurance capabilities of the entrusted warehousing, logistics and distribution enterprises and strengthen food safety management. .

Those engaged in food storage and transportation should strengthen the management of food storage and transportation processes to ensure that food storage and transportation conditions meet food safety requirements.

Those who are entrusted with food storage and transportation shall inspect and retain the identity certificate of the entrusting party, food production and operation license, business license copy, certification documents, inspection and quarantine certificates and other materials in accordance with regulations, and shall be responsible for the storage and food safety responsibilities during transportation.

Article 50 Non-food producers and operators specializing in food storage and transportation shall register with the food and drug supervision and administration department of the local county-level people's government within 30 working days after obtaining a business license.

If complaints, reports, case investigations and other information indicate that non-food producers and operators may have violated food safety laws, regulations and national food safety standards during food storage and transportation activities, the food and drug regulatory authorities shall promptly report Deal with it according to law.

Article 51 If food storage and transportation require temperature, humidity and other controls, equipment and facilities such as insulation, refrigeration or freezing should be provided, and the facilities and equipment should be maintained in effective operation.

Relevant departments of people’s governments at or above the county level should take effective measures to support cold chain transportation.

During the storage and transportation of edible agricultural products, non-edible chemical substances and other substances that may harm human health must not be added, and food additives must not be used beyond the scope or limit.

Article 52 Food storage and transportation should be recorded to ensure that the storage and transportation process can be traced.

When entrusting the storage and transportation of food, both parties should sign a written agreement to clarify the rights and obligations of both parties in terms of food safety.

Article 53 If a catering service unit uses food additives in homemade food, it shall disclose the name, scope of use and dosage of the food additives used.

Article 54 If a catering service provider entrusts a centralized disinfection service unit for tableware and drinking utensils to provide cleaning and disinfection services, it shall sign an entrustment contract with the centralized disinfection service unit for tableware and drinking utensils to inspect and retain tableware and drinking utensils. Provide the business license of the centralized disinfection service unit, certificate of disinfection qualification and other materials.

Article 55: Centralized disinfection service units for tableware and drinking utensils shall establish full-time or part-time health managers, establish and improve health management systems and health management files, and engage in production and business activities in accordance with the requirements of health regulations.

Article 56: Schools, childcare institutions, elderly care institutions, medical institutions, construction sites and other units with canteens shall conduct self-inspections on food safety in canteens, identify potential risks, and regularly report to the local county level The food and drug supervision and administration department of the people's government submits a self-inspection report.

Units that contract canteens to foreign countries must strictly abide by the requirements of laws and regulations, effectively strengthen supervision and inspection, and urge contractors to implement various food safety management systems. Both parties should sign a written agreement to clarify the rights and obligations of both parties in terms of food safety.

Article 57 Local people's governments at or above the county level shall strengthen rural food safety management, clarify food safety management systems and requirements for rural collective dinner activities, and prevent food safety accidents.

The organizers and undertakers of rural collective dinner activities bear the main responsibility for food safety. They should purchase, store, process and prepare food in accordance with food safety requirements, and report in accordance with relevant regulations.

Article 58 If a catering service provider hires a catering service management company for management, both parties shall sign an entrustment contract to clarify the rights and obligations of both parties in terms of food safety. Catering service providers bear legal responsibility for food safety in catering services.

Article 59 Food additive operators shall establish a food additive sales ledger system and truthfully record the names, specifications, quantities, production dates or production batch numbers, shelf life, sales dates and purchases of food additives sold. name, address, contact information, etc., and save relevant credentials. The retention period of records and vouchers shall comply with the provisions of Paragraph 2 of Article 50 of the Food Safety Law.

Food additive operators shall register with the food and drug supervision and administration department of the local county-level people’s government within 30 working days after obtaining a business license.

Article 60: The third-party online food trading platform provider shall, within 30 working days after obtaining the business license, provide the website address, IP address, IP review license certificate, company name, legal representative and its A copy of the ID card, contact information and other information shall be filed with the food and drug supervision and administration department of the local people's government at or above the county level where the platform is registered.

Providers of third-party online food trading platforms should disclose food safety management systems on the platform for inquiry by online food producers, operators and consumers.

Providers of third-party platforms for online food transactions should publish the food safety violation information of online food producers and operators in a conspicuous position on their websites.

Article 61 Online food producers and operators shall obtain food production and operation licenses in accordance with the law, unless otherwise provided by laws and regulations. The business scope of online food producers and operators should be consistent with the permitted scope of their entity transactions.

Article 62 Online food producers and operators shall, within 30 working days from the date of accessing the Internet, file the website address, IP address and other information with the food and drug supervision and administration department that issued the production and operation license, and at the same time shall Disclose its business license, production and operation license and other relevant information in a conspicuous position on the home page of its website or the main page of its business activities. If the food production and operation license or other relevant information changes, online food producers and operators should update it in a timely manner.

Article 63 People’s governments at or above the provincial level may gradually implement food safety electronic traceability systems in high-risk food categories and large-scale food production and operation enterprises based on the actual conditions of their respective administrative regions. Encourage food production and operation enterprises to collect and record production and operation data information through information technology.

Article 64 Food production and operation enterprises, food wholesale markets, etc. shall truthfully report food safety-related data and information to the food and drug supervision and administration department of the local people's government at or above the county level in accordance with the provisions of the food and drug supervision and administration department of the State Council. .

Providers of third-party online food trading platforms shall properly preserve the registration information, transaction data and other materials of online food, edible agricultural products, and food additive producers and operators, and truthfully report them to Report from the food and drug supervision and administration department of the local people's government at or above the county level.

Article 65 Food producers and traders shall, in accordance with the relevant provisions of the national food recall system, carry out production and operation suspension, recall and disposal of unsafe food.

Based on the seriousness and urgency of food safety risks, food recalls are managed at different levels:

Level 1 recall: Food production and operations that have caused or may cause serious health damage or even death after consumption Food producers and operators should initiate a recall within 24 hours after becoming aware of the food safety risk;

Level 2 recall: General health damage has been or may result in general health damage after consumption, and food producers and operators should initiate a recall within 48 hours after becoming aware of the food safety risk Recall;

Level 3 recall: If labels or instructions do not meet food safety standards and generally do not cause health damage, food producers and operators should initiate a recall within 72 hours of becoming aware of the food safety risk.