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Provisions for Routine Supervision and Inspection of Food Production and Distribution


(Decree No. 23 of China Food and Drug Administration)

The Provisions for Routine Supervision and Inspection of Food Production and Distribution, adopted at the executive meeting of China Food and Drug Administration on Feb16, 2016, is hereby promulgated and shall be effective as of May 1, 2016.

Minister:Bi Jingquan
March 4, 2016


Provisions for Routine Supervision and Inspection of Food Production and Distribution

Chapter Ⅰ General Provisions

Article 1 This Provisions is formulated in accordance with the Food Safety Law of the People’s Republic of China and other laws and regulations, in order to intensify the routine supervision and inspection of food production and distribution, determine the primary responsibilities of food producers and distributors, and ensure food safety.

Article 2 The Provisions shall apply to the routine supervision and inspection of food (including food additives) producers and distributors in their compliance with laws, regulations and rules concerning food safety as well as food safety standards conducted by food and drug regulatory departments.

Article 3 The routine supervision and inspection of food production and distribution shall follow the principles known as territorial responsibility, full coverage, risk management and information disclosure.

Article 4 China Food and Drug Administration shall be responsible for overseeing and guiding the routine supervision and inspection of nationwide food production and distribution.

The food and drug regulatory departments at provincial level shall be responsible for overseeing the routine supervision and inspection of food production and distribution in their administrative regions respectively.

The food and drug regulatory departments at municipal or county level shall be responsible for overseeing routine supervision and inspection of food production and distribution in their administrative regions respectively.

Article 5 In implementing routine supervision and inspection of food production and distribution, the food and drug regulatory departments at municipal or county level may, based on a full coverage and within their own administrative regions, randomly target food producers and distributors and randomly assign inspectors to conduct allopatry inspection and crossover inspection.

Article 6 Food producers and distributors and their employees shall cooperate with food and drug regulatory departments to implement the routine supervision and inspection of food production and distribution and ensure the supervision and inspection personnel to perform their duties according to law.

Article 7 The food and drug regulatory departments at or above provincial level shall enhance the informatization construction for routine supervision and inspection of food production and distribution, while the food and drug regulatory departments at city or county level shall record, consolidate and analyze information for routine supervision and inspection of food production and distribution, and improve the measures for routine supervision and inspection.

Food producers and distributors shall submit relevant data information of food production and distribution as required byfood and drug regulatory departments.

Chapter Ⅱ Supervision and Inspection Items

Article 8 The items of supervision and inspection at food production stage shall include the environment and conditions of production, incoming goods checking results, production process control, product testing results, storage and delivery control, management of nonconforming products and food recalls, personnel management, food safety accident handling, etc.

In addition to the items specified in the preceding paragraph, the items of supervision and inspection at the production stage of health food shall include qualification of producers, product labels and instructions, contract production and production management system, etc.

Article 9 The items of supervision and inspection at food sales stage shall include qualification of distributors, personnel health management, implementation of general provisions, implementation of prohibitive provisions, control of distribution process, incoming goods checking results, food storage, recalls of unsafe food, labels and instructions, sales of special food, sales of imported food, food safety accident handling, sales of edible agricultural products as well as the performance of corresponding legal obligations by owners of centralized trading markets for edible agricultural products, counter lessors, trade fair organizers, providers of third-party platforms for online food trade, providers of food storage and delivery.

Article 10 The items of supervision and inspection on the catering service shall include the qualification of catering service providers, health management of catering staff, raw material control, processing procedures, food additives use management and its disclosure, equipment and facility maintenance and tablewarecleaning and sanitization, food safety accident handling, etc.

Chapter Ⅲ Requirements for Supervision and Inspection

Article 11 The food and drug regulatory departments at city or county level shall develop an annual plan for routine supervision and inspection, and carry out food safety risk management upon considering those factors such as food category, enterprise size, management level, food safety status and credit file records as per the annual supervision and management plan for food safety formulated by people's government at city or county level.

The plan of routine supervision and inspection shall include items, measures, frequency, category of sampled food and sampling proportion. The plan shall be published to the public.

Article 12 China Food and Drug Administration shall formulate focal checklist for routine supervision and inspection in accordance with the provisions relating to the obligations of food producers and distributors specified in laws, regulations, rules and food safety national standards.

The food and drug regulatory departments at provincial level may specify and supplement the focal checklists of routine supervision and inspection if necessary.

The food and drug regulatory departments at city or county level shall implement routine supervision and inspection for food producers and distributors in accordance with the focal checklists of routine supervision and inspection.

Article 13 Local food and drug regulatory departments at or above county level shall organize trainings and examinations for inspectors on food safety laws, regulations, rules, standards and professional knowledge as well as key points of supervision and inspection.

Article 14 In implementing routine supervision and inspection, the food and drug regulatory departments at city or county level shall appoint not less than two inspectors.

The inspectors shall be selected randomly by the food and drug regulatory departments.

The inspectors shall produce effective law enforcement certificates on the spot.

Article 15 The food and drug regulatory departments at city or county level may select certain items from the focal checklists of supervision and inspection randomly, and carry out on-site examination randomly, in accordance with the routine supervision and inspection plan. The relevant inspection items shall be determined by the food and drug regulatory departments prior to the implementation inspections, and the inspectors may not alter any inspection items at their own discretions.

Article 16 The annual routine supervision and inspection of food producers and distributors carried out by the food and drug regulatory departments at city or county level in their own administrative regions respectively shall cover all items in principle.

Article 17 For the routine supervision and inspection of food production and distribution, key items shall be primarily subject to on-site inspection, while general items may be subject to paper inspection.

Article 18 Food producers and distributors are encouraged to select a third-party professional organization for food safety to evaluate their food production and distribution management system, and the evaluation results may be used as reference for routine supervision and inspection.

Article 19 The inspectors shall record the situation of the routine supervision and inspection truthfully according to the focal checklists in routine supervision and inspection as well as requirements for log sheets of inspection results, and make a comprehensive assessment to conclude inspection results.

The supervision and inspection results are rated in three: conform,acceptably conform, and non-conform.

The routine supervision and inspection results shall be filed into the food safety credit archives of the food producers and distributors.

Article 20 Food producers and distributors shall follow the requests of the food and drug regulatory departments to give access to their food production and distribution sites, respond to relevant inquiries, provide relevant contracts, bills, account books and other materials, and coordinate with on-site inspection and sampling and testing.

Article 21 Food producers and distributors shall follow the request of the inspectors to sign or seal on the documents of on-site inspection, inquiries and sampling and testing.

Where any entity under inspection refuses to sign or seal on the log sheet of routine supervision and inspection, the inspectors shall note down the reasons on the log sheet. They may invite relevant personnel for signature or seal as witness, or make records in such ways as audio recording and videotaping. And all of these may serve as the evidence of law enforcement.

Article 22 The food and drug regulatory departments at city or county level shall disclose such information of routine supervision and inspection as date, inspection results and names of inspectors to the public within two working days, and the log sheet of routine supervision and inspection results shall be posted at a noticeable location of the production or distribution site.

The log sheet of routine supervision and inspection results posted shall be maintained by the food producers and distributors till the next routine supervision and inspection.

Article 23 For the food producers and distributors with the result of acceptably conform from the routine supervision and inspection, the food and drug regulatory departments at city or county level shall propose rectification requirements with time limit in written form against the deficiencies found in supervision and inspection.

The entities inspected shall make rectification as scheduled, and report the rectification status to the food and drug regulatory departments.

The inspectors may follow the rectification progression and record the rectification results.

Article 24 Where a routine supervision and inspection result is proved as non-conform, and there are potential risks of food safety accidents,the food producers and distributors shall immediately cease the food production and distribution activities.

Article 25 Where the food and drug regulatory departments at city or county level find potential food safety risks during routine supervision and inspection, and the food producers and distributors do not timely take effective countermeasures, the legal representatives or major principals of such producers and distributors shall be subject to inquiries on responsibility.

Information of the inquiries on responsibility and rectification shall be filed into the food safety credit archives of food producers and distributors.

Article 26 In implementing routine supervision and inspection, the food and drug regulatory departments at city or county level have the authority to take the following measures,,and those under inspection shall not refuse, obstruct and interpose:

(I) Enter the food production and distribution sites for on-site inspection.

(II) Carry out sampling and testing to the food produced and distributed by those under inspection.

(III) Review and duplicate relevant contracts, bills, account books and other materials.

(IV) Seal up and detain food, tools and equipment which are not in conformance with food safety standards or proved by evidence to have potential food safety risks and be used for illegal production and distribution.

(V) Seal up the sites for illegal production and distribution.

(VI) Other measures stipulated by laws and regulations.

Article 27 Where the food and drug regulatory departments at city or county level find illegal acts pertaining to food safety in routine supervision and inspection, they shall carry out case investigation. The transcript noting,photograph taking, video recording and other evidence preservation measures made for investigation shall be subject to relevant regulations on food and drug administrative penalty procedure.

Article 28 Where any clues of illegal cases beyond their department responsibilities or jurisdiction are found by the food and drug regulatory departments at city or county level in routine supervision and inspection, the food and drug regulatory departments shall hand the clues over to competent departments timely. Wherean act is suspected of constituting a crime, it shall be handed over to the public security organ timely.

Chapter Ⅳ Legal Liabilities

Article 29 Where a food producer or distributor tears up or obliterates the log sheet of routine supervision and inspection result, or fails to maintain the log sheet until the next routine supervision and inspection, the food and drug regulatory department at city or county level shall issue an order for rectification, give a warning and concurrently impose a fine of not less than CNY 2,000 and not more than CNY 30,000.

Article 30 Where a food producer or distributor violates Article 24 of this Provisions, the food and drug regulatory department at or above county level shall handle it in accordance with Paragraph 1 of Article 126 of the Food Safety Law.

Article 31 Where a food producer or distributor refuses, obstructs or interposes the supervision and inspection carried out by a food and drug regulatory department, and any of the following situations exists, the food and drug regulatory department at or above county level shall handle it in accordance with Paragraph 1 of Article 133 of the Food Safety Law:

(I) Refuse, delay or obstruct the access of inspectors to the sites or regions to be inspected, or limit the inspection duration.

(II) Refuse or obstruct the investigation and evidence collection such as sampling, videotaping, photograph taking and duplication.

(III) Refuse or delay to provide contracts, records, bills, account books, electronic data and other materials relating to inspection without proper reasons.

(IV) Deceive, mislead or avoid inspection by claiming that the major principal, person in charge or relevant personnel is absent, or deliberately suspend the production or distribution.

(V) Hinder inspectors from performing their duties according to law via violence, threat or other means.

(VI) Conceal, transfer, resell or damage the property sealed and detained by inspectors according to law.

(VII) Forge, conceal, destroy evidence or provide false testimony.

(VIII) Other behaviors hindering inspectors from performing their duties.

Article 32 Where a food producer or distributor refuses, obstructs or interposes supervision and inspection, and violates relevant regulations, the food and drug regulatory department shall transfer the case to the public security organ for investigations.

Article 33 Where a food producer or distributor hinders the inspectors from performing their duties according to law by using violence, threats or any other measures, which constitutes a crime, the food and drug regulatory department shall transfer the case to the public security organ for investigations.

Article 34 Where an inspector bears an act of neglection or dereliction of duty in routine supervision and inspection, the appointment and removal organ or the supervisory organ shall investigate the administrative liabilities of the relevant person liable; where an act is suspected of constituting a crime, it shall be transferred to a judicial organ for investigations.

Chapter Ⅴ Supplementary Provisions

Article 35 The routine supervision and inspection conducted by the food and drug regulatory departments at city or county level on individual small workshops for food production and processing or food vendors, may be carried out in reference to this Provisions.

Article 36 The Provisions shall be effective as of May 1, 2016.


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