FREE FULL TEXT | NEW Regulation on the Implementation of the Food Safety Law of the People's Republic of China

Interpretation 2019-11-04
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FOODMATE translated the full text of the Regulation on the Implementation of the Food Safety Law of the People's Republic of China, for your reference.  

Click Interpretation | NEW Regulation on the Implementation of the Food Safety Law of the People’s Republic of China
 

 

State Council of the People's Republic of China

 

 Decree No. 721


The “Regulation on the Implementation of the Food Safety Law of the People's Republic of China” was revised in the 42nd executive meeting of the State Council on March 26, 2019. The revised “Regulation on the Implementation of the Food Safety Law of the People's Republic of China” is hereby released and will be implemented since December 1, 2019.

Prime Minister Li Keqiang

October 11, 2019

 

Regulation on the Implementation of the Food Safety Law of the People's Republic of China

(Released by Decree No. 557 of the State Council of the People's Republic of China on July 20, 2009

Revised according to “Decision of the State Council on Amending Some Administrative Regulations” on February 6, 2016

Revised and approved in the 42nd executive meeting of the State Council on March 26, 2019)

 


Chapter I General Provisions


Article 1
 The Regulation is formulated according to the “Food Safety Law of the People's Republic of China” (hereinafter referred to as the Food Safety Law).


Article 2
The food producers and operators shall follow laws, regulations and food safety standards to be engaged in the production and operation, establish and improve the food safety management system and take effective measures to prevent and control the food safety risks to ensure the food safety.


Article 3 The Food Safety Commission of the State Council is responsible for analyzing the food safety trend, studying, deploying and guiding the food safety as a whole, proposing major policy measures for food safety supervision and administration and supervising the implementation of food safety supervision and administration responsibilities. The food safety committees of local people's governments above the county level shall carry out their work in accordance with the responsibilities prescribed by the people's governments at the same level.

 

 
Article 4 The local people's governments above the county level shall establish uniform and authoritative food safety supervision and administration system and strengthen the construction of food safety supervision and administration capabilities.


The food safety supervision and administration departments and other related departments of local people's governments above the county level shall perform their responsibilities according to law, strengthen coordination and cooperation and properly supervise and manage the food safety.


The people's governments of township and the subdistrict offices shall support and help the food safety supervision and administration departments of local people's governments and their agencies at the county level to supervise and manage the food safety according to law.

 


Article 5 
The state shall include the food safety knowledge into national quality education, and popularize the scientific and legal knowledge of food safety to improve the food safety awareness of the whole society.

 

 

 Chapter II Food Safety Risk Monitoring and evaluation

 
Article 6The health administrative departments of the people's governments above the county level shall establish the food safety risk monitoring consultation mechanism in conjunction with the departments related to food safety supervision and administration, etc. at the same level to summarize and analyze the risk monitoring data and form the food safety risk monitoring analysis reports, which shall be submitted to the people's government at the same level. The health administrative departments of the local people's governments above the county level shall also submit the food safety risk monitoring analysis reports to the health administrative department of the superior people's government.Specific measures for food safety risk monitoring consultation shall be formulated by the health administrative department of the State Council in conjunction with the food safety supervision and administration department, etc. of the State Council.

Article 7 If the food safety risk monitoring results show the hidden danger of food safety, the food safety supervision and administration department, etc. shall make further investigation, and notify the food producers and operators in time if necessary.


The food producers and operators receiving notice shall self-inspect themselves immediately. If discovering that the foods are inconsistent with food safety standards or there is evidence of possible harm to human health, production and operation shall be suspended, foods shall be recalled and relevant information shall be reported as specified in Article 63 of the Food Safety Law.


Article 8 The health administrative department, food safety supervision and administration department, etc. of the State Council shall propose the safety evaluation suggestions for the agricultural administration department of the State Council if discovering the safety evaluation is required for pesticides, fertilizers, veterinary drugs, fodders, feed additives, etc. The agricultural administration department of the State Council shall organize the evaluation in time and report the evaluation results to the relevant departments of the State Council.


Article 9 The food safety supervision and administration department and other related departments of the State Council shall establish the food safety risk information communication mechanism to indicate the content, procedures and requirements of the food safety risk information communication.

 Chapter III Food Safety Standards

 


Article 10
The health administrative department of the State Council shall formulate the national standard planning and its annual implementation plan of food safety in conjunction with the food safety supervision and administration department and the agricultural administration department of the State Council.The health administrative department of the State Council shall publish the drafts of the national standard planning and its annual implementation plan of food safety in its website and seek public opinions.

Article 11 The health administrative departments of the people's governments in provinces, autonomous regions and municipalities directly under the central government shall formulate the local food safety standards as stipulated in Article 29 of the Food Safety Law and seek public opinions. The health administrative departments of the people's governments in provinces, autonomous regions and municipalities directly under the central government shall submit the local standards to the health administrative department of the State Council within 30 working days since the date when the local standard of food safety is issued.The health administrative department of the State Council shall make timely correction if finding the filed local food safety standards violate laws, regulations or national food safety standards.

If the local food safety standards are abolished according to law, the health administrative departments of the people's governments in provinces, autonomous regions and municipalities directly under the central government shall publish the abolishment in their websites in time.


Article 12Health foods, formulas for special medical purpose, infant formulas and other special foods are excluded in the local specialty foods, and the local food safety standards cannot be formulated for them.


Article 13After the food safety standards are issued, the food producers and operators may implement the standards and publicize the implementation in advance before the implementation date specified in the food safety standards.


Article 14 Food production enterprises cannot formulate the enterprises standards lower than the national standards or local food safety standards.If the food production enterprises formulate the food safety indexes stricter than the enterprise standards specified in the national standards or local food safety standards, the health administrative departments of the people's governments in provinces, autonomous regions and municipalities directly under the central government shall be reported for filing.


If formulating the enterprise standards, the food production enterprises shall publicize the standards which are free for public look-up.

 Chapter IV Food Production and Operation

 
Article 15The food production and business license shall be valid for 5 years.

If the production and operation conditions of food producers and operators change and are inconsistent with the food production and operation requirements, the food producers and operators shall take rectification measures immediately. If it is necessary to handle the licensing formalities again, the formalities shall be fulfilled according to law.


Article 16 The health administrative department of the State Council shall publish the list of new food raw materials, new varieties of food additives, new varieties of food-related products and applicable national food safety standards.


The health administrative department of the State Council shall update the list of materials which are traditional foods and traditional Chinese medicinal materials in conjunction with the food safety supervision and administration department of the State Council.


Article 17 The food safety supervision and administration department of the State Council shall indicate the basic requirements for traceability in the whole process of food safety in conjunction with the agricultural administrative department of the State Council and guide the food producers and operators to establish and improve the food safety traceability system by information means.


The food safety supervision and administration department and other departments shall regard the traceability system construction of infant formulas and other foods for special group as well as other foods with higher food safety risk or large sales volume as emphasis of supervision and inspection.


Article 18 The food producers and operators shall establish the food safety traceability system, and truthfully record the preserve such information as purchasing inspection, delivery inspection and food sales as per the Food Safety Law to ensure foods are traceable.

Article 19 Major principals of the food production and operation enterprises shall take full responsibility for their food safety, establish and implement their food safety responsibility system, and strengthen the supplier management, purchasing inspection and delivery inspection, production and operation process control, food safety self-inspection, etc.The food safety management personnel of food production and operation enterprises shall assist major principals of enterprises in the food safety management.


Article 20 Food production and operation enterprises shall strengthen the training and assessment for food safety management personnel. The food safety management personnel shall grasp the food safety laws, regulations, standards and specialized knowledge adaptive to their posts and shall be capable of food safety management. The food safety supervision and administration department shall randomly supervise, inspect and assess the food safety management personnel of enterprises. The assessment guide is formulated and released by the food safety supervision and administration department of the State Council.


Article 21 If the producers and operators of foods and food additives entrust the production of foods and food additives, the producers acquiring food production license and food additive production license shall be entrusted for production, and their production behaviors shall be supervised. They shall be responsible for the safety of foods and food additives entrusted for production.The trustee shall produce in accordance with laws, regulations, food safety standards and contractual stipulations, and shall be responsible for production and accept the supervision of the entrusting party.


Article 22 The food producers and operators cannot store the materials specified in the list which is formulated in Article 63 of the Regulation in the places of food production and processing.


Article 23 The irradiation processing of foods shall comply with the national food safety standards, and the foods after the irradiation processing shall be inspected and marked in accordance with the requirements of the national food safety standards.


Article 24 Foods with special requirements for temperature and humidity shall be stored and transported with heat preservation, refrigeration or freezing equipment and facilities, which shall keep running effectively.


Article 25 Where food producers and operators entrust the storage or transportation of foods, they shall review the food safety guarantee ability of the trustee and supervise the trustee to store and transport the foods in accordance with the requirements for ensuring food safety. The trustee shall ensure that the food storage and transportation conditions meet the requirements of food safety and strengthen the management of food storage and transportation processes.


Where the food producers and operators' entrustment of the storage and transportation of foods is accepted, the name, address and contact information of the entrusting party and the consignee shall be recorded truthfully. The record retention period shall not be less than 2 years after storage and transportation of foods.


Non-food producers and operators engaged in food storage business with special requirements for temperature, humidity, etc. shall file with the food safety supervision and administration department of the local people's government at the county level within 30 working days from the date of obtaining the business license.


Article 26 Where a catering service provider entrusts a centralized disinfection service unit of tableware and drinkware to provide cleaning and disinfection services, it shall inspect and retain a copy of the business license and disinfection certificate of the centralized disinfection service unit of the tableware and drinkware. The retention period shall not be less than 6 months after the expiration of the service life of the disinfected tableware and drinkware.

Article 27 The centralized disinfection service unit for tableware and drinkware shall establish a factory inspection record system for tableware and drinkware, truthfully record the quantity, disinfection date and batch number, service life and ex-factory date of the ex-factory tableware and drinkware, and the name, address and contact information of the entrusting party. The retention period of the delivery inspection record shall not be less than 6 months after the expiration of the service life of the disinfected tableware and drinkware. The individual package of tableware and drinkware disinfected shall be marked with the company name, address, contact information, date of disinfection, batch number and service life, etc.


Article 28 The canteens of companies adopting centralized dining such as schools, kindergarten units, nursing institutions for the aged, and construction sites shall implement systems for the control of raw materials, cleaning and disinfection of tableware and drinkware, food sample reserving, etc., and carry out food safety self-examination of canteens on a regular basis in accordance with Article 47 of the Food Safety Law.


If the canteen of a company adopting centralized dining is contracted, it shall obtain a food business license according to law and be responsible for the food safety of the canteen.The company adopting centralized dining shall supervise the contractor to implement the food safety management system and assume management responsibilities.


Article 29 Food producers and operators shall clearly mark or store the foods that have deteriorated, exceeded the shelf life or been recycled in a place with clear signs independently, and take measures such as harmless disposal and destruction in a timely manner and record them truthfully.


The term "recycled food" as used in the Food Safety Law refers to a food that has been sold and recalled or returned due to violation of laws, regulations, or food safety standards or expiration of the warranty period, excluding the foods that can be sold continuously in accordance with the provisions of Clause III, Article 63 of the Food Safety Law.


Article 30 Local people's governments at or above the county level shall construct necessary food harmless disposal and destruction facilities as needed. Food producers and operators can use the facilities built by the government to carry out harmless disposal or destruction of foods in accordance with provisions.

Article 31 The promoters of centralized food trading markets and the organizers of food trade fairs shall report to the food safety supervision and administration department of the local people's government at county level before the opening of the markets or the holding of the trade fairs.


Article 32 The providers of the third-party platforms for online food transactions shall properly keep the registration information and transaction information of the food traders joining the platforms. The food safety supervision and administration department of the local people's government at or above the county level indeed needs to understand the relevant information in conducting food safety supervision and inspection, food safety case investigation and handling, and food safety accident handling, it may require the providers of the third-party platforms for online food transactions to provide the information after approval by its principal. The providers of the third-party platforms for online food transactions shall provide the same as required. The food safety supervision and administration department of the local people's government at or above the county level and its staff shall be obliged to keep confidential the information provided by the providers of the third-party platforms for online food transactions.


Article 33 The production and operation of genetically modified foods shall be marked clearly, and the marking methods shall be formulated by the food safety supervision and administration department of the State Council in conjunction with the agricultural administration department of the State Council.


Article 34 It is forbidden to use any means including meetings, lectures, and health consultations to organize false propaganda on foods. If the food safety supervision and administration department identifies a false propaganda activity, it shall promptly handle it according to law.


Article 35 Where the production process of health foods involves pre-treatment processes such as raw material extraction and purification, the production enterprises shall have the corresponding pre-treatment capacity of raw materials.


Article 36 A production enterprise of special medical formula foods shall carry out lot by lot inspection of the ex-factory products in accordance with the inspection items stipulated by the national food safety standards.


Specific all-nutritional formula foods in formulas for special medical uses shall be sold to consumers through medical institutions or pharmaceutical retailers.Where the medical institutions and pharmaceutical retailers sell the specific all-nutritional formula foods, they do not need to obtain food business licenses, but they shall comply with the Food Safety Law and the provisions of the Regulation on food sales.


Article 37 The advertisements for specific all-nutritional formula foods in formulas for special medical uses shall be managed as prescription drug advertisements, and other types of special medical formula food advertisements shall be managed as over-the-counter advertisements.


Article 38 No food other than health food may claim to have healthcare functions.


Infant formulas supplemented with optional added substances as per the national food safety standards shall not be named after the optional added substances.


Article 39 The contents of the labels and instructions of special foods shall be consistent with those of the registered or filed labels and instructions. For the sale of special foods, the contents of the food labels and instructions shall be checked for consistency with those of the registered or filed labels and instructions. If they are not consistent, they shall not be sold. The food safety supervision and administration department of the local people's government at or above the provincial level shall publish the labels and instructions for the special foods registered or filed on its website.


Special food shall not be placed together with ordinary food or medicine for sale.

 Chapter V Food Inspection


Article 40 The sampling inspection of food shall be carried out in accordance with the food safety standards, the technical requirements for the products of the special foods registered or filed, as well as the inspection items and methods determined by the relevant national regulations.


Article 41 Where the foodstuffs that may be adulterated cannot be inspected in accordance with the inspection items and methods stipulated by the existing food safety standards and the provisions of Article 111 of the Food Safety Law and Article 63 of the Regulation, the food safety supervision and administration department of the State Council may formulate supplementary inspection items and methods for sampling inspection of food, investigation of food safety cases and handling of food safety accidents.


Article 42 Where an application for re-inspection is made in accordance with the provisions of Article 88 of the Food Safety Law, the applicant shall pay the re-inspection fee to the re-inspection agency in advance. If the conclusion of the re-inspection indicates that the food is unqualified, the re-inspection fee shall be borne by the re-inspection applicant; if it indicates that the food is qualified, the re-inspection fee shall be borne by the food safety supervision and administration department that performs the sampling inspection.

The re-inspection agency may not refuse to undertake the re-inspection task without just causes.


Article 43 No unit or individual may publish food inspection information issued by a food inspection agency that has not obtained the qualification confirmation according to law, and may not use the above-mentioned inspection information to rank food and food producers and operators, or to deceive or mislead consumers.

 Chapter VI Food import and Export


Article 44
 importers importing food and food additives shall report to the entry and exit inspection and quarantine institutions in accordance with the provisions, truthfully declare the relevant information of the products, and accompany the certification materials stipulated by laws and administrative regulations.


Article 45 After the imported food arrives at the port, it shall be stored in the place designated or approved by the entry and exit inspection and quarantine institution; if it needs to be moved, necessary safety protection measures shall be taken in accordance with the requirements of the entry and exit inspection and quarantine institution. Bulk imported food shall be inspected at the unloading port.


Article 46
 The national entry and exit inspection and quarantine department may, according to the needs of risk management, implement the system of importing some foods at designated ports.


Article 47 The Health Administrative Department under the State Council shall, in accordance with the provisions of Article 93 of the Food Safety Law, examine the relevant national (regional) standards or international standards submitted by overseas exporters, overseas production enterprises or their authorized importers, and if it considers that they meet the requirements of food safety, they shall be allowed for temporary application and published. Before the publication of the applicable standards temporarily, the food that does not have the national food safety standards shall not be imported.


The food covered by the general standard in the national food safety standard does not belong to those that do not have the national food safety standard as stipulated in Article 93 of the Food Safety Law.

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