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USDA Foreign Agricultural Service

GAIN Report

Global Agriculture Information Network Template Version 2.09

Voluntary ReportCH9019 Page 2 of 21

Executive Summary: On February 28, China’s National People’s Congre(NPC)Standing Committee paed the first comprehensive Food Safety Law(FSL)after five years of drafting;the first draft was read in December 2007.The FSL will go into effect on June 1, 2009.For the first time, the Chinese Government uses Western terminology in calling for food safety regulation “from the production line to the dining table.” Key organizational provisions create a state-level Food Safety Commiion to oversee food-safety monitoring.This Commiion will be composed of members from the Ministry of Health(MOH), Ministry of Agriculture(MOA), General Administration for Quality Supervision, Inspection and Quarantine(AQSIQ), State Food and Drug Administration(SFDA)and the State Administration for Industry and Commerce(SAIC).Other key provisions deal with supervision, monitoring, enforcement, recall, trace back, licensing, registration, and development of standards and regulations.A complete analysis of this law is provided in GAIN Report CH9018.This report is an UNOFFICIAL translation of this law.BEGIN TRANSLATION

Food Safety Law of the People’s Republic of China

The Food Safety Law of the People’s Republic of China has been adopted at the 7th Seion of the 11th Standing Committee of the National People’s Congre of the People’s Republic of China on February 28, 2009, is now iued, and shall be effective as of June 1, 2009.President of the People’s Republic of China Hu Jintao February 28, 2009

Food Safety Law of the People’s Republic of China

(adopted at the 7th Seion of the 11th Standing Committee of the National People’s Congre of the People’s Republic of China on February 28, 2009)Table of Content Chapter 1.General Provisions Chapter 2.Surveillance and Aement of Food Safety Risks Chapter 3.Food Safety Standards Chapter 4.Food Production and Trade Chapter 5.Inspection and Testing of Food Chapter 6.Food Import and Export Chapter 7.Response to Food Safety Incidents Chapter 8.Supervision and Administration Chapter 9.Legal Liabilities Chapter 10.Supplementary Provisions UNCLASSIFIED USDA Foreign Agricultural Service GAIN ReportCH9019 Page 4 of 21

regulatory responsibilities of food safety under the integrated organization and coordination of the lower level government.Article 6 The administrative departments of health, agriculture, quality supervision, industry and commerce, and food and drug administration at the county level or above shall enhance communication, coordination, exercise the rights and bear the responsibilities in accordance with their respective duties.Article 7 Food industry aociations shall tighten the self-discipline of the industry, and guide food producers and traders to produce and trade according to law, facilitate the construction of industry creditability, and publicize and spread knowledge related to food safety.Article 8 The State encourages social and community groups to conduct educational activities regarding food safety laws and regulations, food safety standards and knowledge, to advocate healthy diets, and to raise consumers’ food safety awarene and self-protection ability.The media shall publicize food safety laws, regulations, standards and knowledge for free and provide public oversight on acts that violate the Law.Article 9 The State encourages and supports basic and applied research related to food safety and encourages and supports food producers and traders to adopt advanced technologies and management practices for the sake of enhanced food safety.Article 10 Any organization or individual has the right to report any act during food production and trade that violates this Law and has the right to inquire food safety information from relevant agencies and provide comments and suggestions about food safety regulation.Chapter 2: Surveillance and Aement of Food Safety Risks Article 11 A national surveillance system for food safety risks shall be established to monitor food-borne diseases, food contamination and other food-related hazards.The executive department of health under the State Council, in conjunction with other relevant departments of the State Council, shall formulate and enforce a national surveillance plan on food safety risks.The executive departments of health at the people’s governments of provinces, autonomous regions and municipalities directly under the central government shall formulate and enforce surveillance plans on food safety risks within their respective jurisdiction in accordance with the national surveillance plan on food safety risks and taking into account regional particularities.Article 12 The executive departments on agriculture, quality supervision, industry and commerce, and food and drug administration under the State Council shall immediately report to the executive department of health under the State Council after hearing any information on food safety risks.The executive department of health under the State Council shall in a timely manner adjust the surveillance plan on food safety risks upon verification of the information with other relevant authorities.Article 13 A national aement mechanism for food safety risks shall be established to ae the risks on biological, chemical and physical hazards in foods and food additives.The executive department of health under the State Council shall be responsible for organizing food safety risk aements.An expert committee on food safety risk aement which is composed of experts on medical science, agriculture, food, and nutrition, shall be established to conduct the food safety risk aement.UNCLASSIFIED USDA Foreign Agricultural Service GAIN ReportCH9019

6)Quality requirements related to food safety;7)Methods and procedures for food testing;and 8)Other particulars neceary for developing food safety standards.Page 6 of 21 Article 21 The executive department of health under the State Council shall be responsible for developing and publicizing national food safety standards and the standardization administrative department under the State Council shall provide the national standard number.The limits of pesticide residue and veterinary drug residue in food and their testing methods and procedures shall be developed by the executive department of health and agriculture under the State Council.The testing procedures for slaughtering livestock and poultry shall be developed by the competent authorities under the State Council in conjunction with the executive department of health under the State Council.In case a product’s national standard involves the national food safety standard, it shall be consistent with the national food safety standard.Article 22 The executive department of health under the State Council shall consolidate the mandatory standards among existing quality and safety standards for edible agricultural products, food hygiene standards, food quality standards, and relevant industry standards related to food and iue unified national food safety standards.Before iuance of the national food safety standards specified in the Law, food producers and traders shall produce or trade food based on existing quality and safety standards for edible agricultural products, food hygiene standards, food quality standards, and relevant industry standards related to food.Article 23 The national food safety standards shall be reviewed and approved by the national food safety standard evaluation committee which is composed of experts in medicine, agriculture, food, and nutrition as well as representatives from relevant departments under the State Council.The formulation of national food safety standards shall base on the results of food safety risk aements and take full account of the results of quality and safety risk aements for edible agricultural products, shall reference to the relevant international standards and the results of international food safety risk aements, and shall solicit extensively the opinions from food producers, traders, and consumers.Article 24 In the absence of a national food safety standard, a local food safety standard may be developed.The executive departments of the people’s governments at the provincial, autonomous region, and municipal levels shall organize the drafting of local food safety standards with reference to the provisions of this Law regarding formulation of national food safety standards and report to the executive department of health under the State Council for record.Article 25 In the absence of a national or local food safety standard, the food enterprise may develop an enterprise standard as this basis for production.The State encourages food enterprises to develop enterprise standards more stringent than the national or local food safety standards.The enterprise standard is applicable only to the enterprise and shall be reported to the executive department of health at the provincial level for record.UNCLASSIFIED USDA Foreign Agricultural Service GAIN ReportCH9019 Page 8 of 21

5)Meat or meat products of poultry, livestock, animals, or aquatic animals that die from disease, poison, or any unidentified causes;6)Meat or meat products that have not been inspected and quarantined by animal health supervisory agencies or have failed to pa such inspection and quarantine;7)Food contaminated by packaging materials, containers or means of transport;8)Food exceeding the shelf life;9)Pre-packaged products without labels;10)Food exprely prohibited by the State from production and trading for special purposes such as disease prevention;11)Other food failing to meet food safety standards or requirements.Article 29 The State implements a licensing system for food production and trading.Any organization or individual shall obtain a food production license, food distribution license, or catering service license according to law before engaging in food production, food distribution, or catering service.Food producers having a food production license are not required to obtain a food distribution license when selling foods produced by themselves at their production premises;catering service providers having a catering service license are not required to obtain a food production or distribution license when selling foods produced by themselves at their service premises;farmers are not required to obtain a food distribution license when selling edible agricultural products produced by themselves.Small food workshops and food vendors that engage in food production and trading activities shall comply with the food safety requirements of the Law suitable for their production or trading scale and conditions ensure that the food being produced or traded are clean, nontoxic and harmle.The relevant authorities shall strengthen the supervision and management over these individuals.Detailed management measures shall be developed in accordance with the Law by the standing committees of the People’s Congre at the provincial, autonomous region, and municipal levels.Article 30 The People’s Governments at the county level or above shall encourage small food workshops to improve the production conditions and encourage food vendors to trade in fixed locations, such as centralized markets and shops.Article 31 The executive departments of health, agriculture, quality supervision, industry and commerce, and food and drug administration at the county level or above shall review applicants’ documents as required by Article 27.1 – 4 of the Law in accordance with the Law of the People’s Republic of China on Administrative Licensing, and shall inspect the applicant’s production or trading place if neceary.For applicants that comply with the requirements, a license shall be granted;for those that fail to comply with the requirements, a license shall not be granted with reasons in writing.Article 32 Food producers and traders shall establish a food safety management system, strengthen the training of the employees on food safety knowledge, aign the full-time or part-time food safety management personnel, properly conduct inspection of the foods for operation and conduct the food production and trading according to law.Article 33 The State encourages food producers and traders to comply with good manufacturing practices(GMP)and to implement the Hazard Analysis and Critical Control Point(HACCP)system in order to improve food safety management level.For food enterprises having been certified with GMP and HACCP, the certification institutions shall conduct the follow-up investigations according to law;for those failing to comply with the certification requirements, the certification institutions shall cancel UNCLASSIFIED USDA Foreign Agricultural Service GAIN ReportCH9019 Page 10 of 21

For food trading enterprises that adopt a centralized distribution model, the headquarters of the enterprises may centrally check the license of the supplier and compliance certificates of the food and create an inspection record for incoming food products.Article 40 Food traders shall store food in accordance with food safety aurance requirements, and regularly check the food in storage and remove the spoiled or outdated food in a timely manner.Article 41 Food traders shall indicate at the storage facility such information as food name, production date, shelf life, and name and contact information of the producer when storing food in bulk.Food traders shall indicate on the container or external package the food name, production date, shelf life, and name and contact information of the trader when selling food in bulk.Article 42 Pre-packaged food shall be labeled on the package, which indicate the following: 1)Name, specification, net content, and date of production;2)Table of ingredients or formulation;3)Producer name, addre and contact information;4)Shelf life;5)Code of product standard(s);6)Storage requirements;7)Generic name of the food additives as used in the national standard;8)Production License Number;and 9)Other information that must be indicated in accordance with applicable laws, regulations, and food safety standards.The labels of staple and supplementary food dedicated to babies and other specific populations shall also indicate main nutritional ingredients and their contents.Article 43 The State adopts a licensing system for the production of food additives.The conditions and procedures of applying for a food additive production license shall be implemented in accordance with the relevant State regulations governing the administration of production licensing for industrial products.Article 44 Any organization or individual applying for production of novel foods, new food additive varieties, or new food-related products shall submit the aement materials relative to the product to the executive department of health under the State Council.The executive department of health under the State Council shall organize a review of the safety aement materials within sixty(60)days upon receipt of the application.For applications that comply with food safety requirements, a license shall be granted and made public.For applications that fail to comply with the safety requirements, a license shall not be granted with an explanatory note in writing.Article 45 A food additive can be incorporated into the scope permitted for use only after it is technically required and proven to be safe and reliable through the risk aement.The executive department of health under the State Council shall timely revise the standards on varieties, scope of application, and dosage levels of food additives in accordance with technical neceity and the results of food safety aements.Article 46 Food producers shall apply food additives in accordance with food safety standards governing food additive varieties, scope of application and dosage levels and UNCLASSIFIED USDA Foreign Agricultural Service GAIN ReportCH9019 Page 12 of 21

Food producers shall take actions such as remedy, removal of harm, or destruction of the recalled food, and report the food recall and treatment to the quality supervision department at the county level or above.In the event that a food producer or trader fails to recall or stop trading of the food that does not comply with the food safety standards as required in the Article, the executive departments of quality supervision, industry and commerce, and food and drug administration at the county level or above may order it to recall or stop trading of the food.Article 54 Food advertisements shall provide truthful information, shall not include any false or exaggerated information, and shall not claim any disease prevention or treatment functions.Food safety regulatory agencies or institutions undertaking food inspection and testing, food industry aociations, or customer aociations shall not recommend food to customers through advertisements or in any other forms.Article 55 Civil societies or other organizations or individuals who recommend a food to consumers in untruthful advertisements that has caused damages to the lawful rights and interests of the customers shall bear joint liabilities with the food producer and trader.Article 56 Local people’s governments at all levels shall encourage scale production and chain operation and distribution of food.Chapter 5: Food Testing Article 57 Food testing agencies shall perform food testing only after they have been accredited in accordance with relevant State requirements on certification and accreditation, unle otherwise specified in other laws.The accreditation conditions and testing procedures for food testing agencies shall be determined by the executive department of health under the State Council.Food testing agencies which have been established by competent departments of the State Council or have been accredited before the implementation of the Law may continue to perform food testing activities based on the Law.Article 58 Food testing shall be performed independently by a food testing agency designated inspector.The inspector shall test the food based on laws, regulations, food safety standards, and inspection and testing procedures.The inspector shall follow the science, observe profeional ethics, and make sure that the testing data and conclusions are objective and fair.He or she must not iue false inspection testing reports.Article 59 The food testing agency and the inspector shall be responsible for the food testing.Food testing reports shall bear the official seal of the food testing agency and the signature or seal of the inspector.The food testing agency and the inspector shall be held responsible for the food testing report.Article 60 The food safety regulatory departments shall not grant exemptions on food inspection.The executive departments of quality supervision, industry and commerce, and food and drug administration at the county level or above shall conduct sample testing regularly or irregularly on food products.They shall pay for the samples to be tested and shall not collect testing fees.UNCLASSIFIED USDA Foreign Agricultural Service GAIN ReportCH9019 Page 14 of 21

Article 68 Exported food shall be supervised and randomly inspected by the exit-entry inspection and quarantine agencies.The customs shall release the products upon receipt of a clearance certificate iued by the exit-entry inspection and quarantine agencies.Producers of exported food, planting or breeding farms of raw materials for exported food shall be put on record at the national exit-entry inspection and quarantine department.Article 69 The national exit-entry inspection and quarantine department shall collect and consolidate safety information on imported and exported food and notify it to relevant departments, institutions, and enterprises.The national exit-entry inspection and quarantine department shall establish and publish credit records of food importers, exporters, and export food producers and shall tighten inspection and quarantine on importers, exporters, and export food producers that have an unhealthy credit record.Chapter 7: Handling of Food Safety Incidents Article 70 The State Council shall organize the formulation of emergency plans for national food safety incidents.Governments at the county level or above shall formulate emergency plans for food safety incidents within their jurisdiction based on relevant laws, regulations, and the emergency plan of the higher level government and the local situation and shall submit their plans to the higher level government for the official record.Food producers and traders shall develop a response plan for food safety incidents, regularly inspect the implementation of preventive measures related to food safety, and eliminate potential food safety risks in a timely manner.Article 71 The organization where a food safety incident has occurred shall take immediate actions to prevent the incident from spreading.The organization where the incident has occurred and institution that receives and treats the patients shall immediately report to the executive department of health at the county of jurisdiction.The executive departments of agriculture, quality supervision, industry and commerce, and food and drug administration shall report to the executive department of health upon discovering a food safety incident or hearing a report on food safety incident.In the event of a major food safety accident, the executive department of health at the county level having received the report shall report to the local People’s Government and the executive department of health at the higher People’s Government.The People’s Government of the county level and the executive department of health at the higher level shall report to higher authorities accordingly.Any organization or individual shall not conceal, lie, delay, or intentionally destroy the evidence of any food safety accident.Article 72 Upon receiving the food safety incident report, the executive department of health at the county level or above shall immediately work with the executive departments of agriculture, quality supervision, industry and commerce, and food and drug administration on investigation and handling of the incident and take the following measures prevent or mitigate the hazard to the public:

1)Deploy emergent rescue and the executive department of health shall arrange first aid and treatment to the injured persons from the food safety accident;2)Seal up the food and raw materials likely causing the food safety accident and conduct immediate testing;for the confirmed food and raw material contamination, order the food producer and trader to recall, suspend operation, and destroy the product according to Article 53 of the Law;

UNCLASSIFIED USDA Foreign Agricultural Service GAIN ReportCH9019 Page 16 of 21

supervision, inspection and punishment in the course of overseeing and inspecting food producers and traders.Such records shall be signed by supervision and inspection officers and food producers and traders before filing.Article 79 The executive departments of health, quality supervision, industry and commerce, and food and drug administration at the county level or above shall establish and maintain food safety credit records for food producers and traders, record iuance of licenses, results of routine supervision and inspection, and handling of illegal activities;and shall increase the frequency of supervision and inspection on food producers and traders with unhealthy credit records based on the food safety credit records.Article 80 Upon receiving any inquiry, complaint, or information, the executive departments of health, quality supervision, industry and commerce, and food and drug administration at the county level or above shall accept, promptly verify, and handle such an inquiry, complaint, or other information.The departments shall transfer matters beyond their duty and authority to other departments empowered to deal with such iues, which shall act immediately and not push responsibility to others.Matters belong to food safety incidents shall be handled according to Article 7 of the Law.Article 81 The executive department of health, quality supervision, industry and commerce, and food and drug administration at the county level or above shall perform the regulatory duties on food safety according to their statutory authority and procedures.They shall not impose two or more administrative penalties on the same illegal food production or trading activity.Anyone suspected of violating criminal law shall be handed to the public security authorities according to law.Article 82 The State shall establish a unified food safety information release system.The following information shall be centrally disclosed by the executive department of health under the State Council: 1)Overall situation of food safety in the country;

2)Food safety risk aement and food safety risk alert;3)Information on major food safety incidents and the handling;and 4)Other important food safety information and information identified by the State Council as requiring centralized disclosure.The information set forth in 2)and 3)may, if its impact is limited to particular regions, be disclosed by the health departments of the people’s governments of relevant provinces, autonomous regions and municipalities.The executive departments of agriculture, quality supervision, industry and commerce, and food and drug administration, shall disclose information on routine supervision and administration of food safety in accordance with their respective duties and responsibilities.The regulatory departments on food safety shall disclose information on a timely, objective, and accurate basis.Article 83 Upon receiving information requiring central disclosure pursuant to Article 82(1), the executive departments of health, agriculture, quality supervision, industry and commerce, and food and drug administration at the county level or above shall immediately report to their superior departments, which then shall immediately report to the executive department of health under the State Council, and, if neceary, they may directly report to the executive department of health under the State Council.The executive departments of health, agriculture, quality supervision, industry and commerce, and food and drug administration at the county level or above shall notify each other of any food safety related information.UNCLASSIFIED USDA Foreign Agricultural Service GAIN Report50,000 if the total value of the food or food additive is le than RMB 10,000 or a fine between 5 and 10 times of the total value of the commodity if the total value of the commodity exceeds RMB10,000.Article 85 In violation of the Law with one of the following circumstances, the food producer or trader shall have the illegal benefits, including foods or food additives illegally produced or traded, and tools, equipment and food raw material, used for illegal production or trading confiscated by the relevant authorities according to their respective duties and responsibilities, and be subject to a fine of RMB2,00050,000 if the total value of the commodity is le than RMB 10,000;or a fine between 5 and 10 times the total value of the UNCLASSIFIED USDA Foreign Agricultural Service GAIN Report20,000;and for the serious cases, be ordered to stop production or busine, until revoked the busine license：

1)Fail to test the purchased food materials, produced food, food additives, and

food related products;2)Fail to establish and observe the inspection record system and ex-factory inspection record system;3)Fail to file for record of the enterprise food safety standard according to the Law;4)Fail to store or sell food or clear off food in stock according to the regulations;5)Fail to check the license or relevant certificates upon receiving incoming products;6)Claim the functions of disease prevention and treatment in the label and instructions for the produced food and food additives;7)Allow the person with diseases listed in Article 34 of the Law to execute the work contacting the food for direct consumption.Article 88 In violation of the Law upon occurrence of any accident, the food producer or trader failing to make disposal or reporting shall be ordered to make correction or warned by the relevant authorities according to their respective duties and responsibilities;when destroying the evidence, be ordered to suspend the production or trading and subject to a fine of RMB2,000CH9019 Page 19 of 21

serious consequences are caused, order suspension of operations for correction and revocation of its license by the original iuer.Article 91 Where anyone or organization engages in food transportation activities in violation of this Law, the relevant authorities shall order immediate correction and give a warning;if correction is refused, order suspension of operations for correction and impose a fine between RMB 20,000 and RMB 50,000 according to their respective duties and responsibilities;and in serious circumstances, order revocation of its license by the original iuing department.Article 92 For any organization whose license for food production, distribution or catering service has been revoked of, the direct responsible manager shall not be permitted for management of food production and/or trading activities within 5 years after the punishment.If any organization for food production/trading engages any person not permitted for management of food production and/or trading activities, the license shall be revoked by the original iuing authority.Article 93 If any food inspection agency or personnel iues false inspection reports in violation of this Law, the original authorities or institution granting its qualification shall revoke its certificate of qualification.The manager and personnel directly responsible shall be removed from office or dismied.Any food inspection personnel iuing false inspection reports in violation of this Law shall, if he/she has been subject to criminal prosecution or removed from office or dismied, be prohibited from any food inspection work within ten(10)years thereafter.Any food inspection agency employing any person prohibited from food inspection work will be subject to revocation of its certificate of qualification by the original authorities or institution granting its qualification.Article 94 Any advertising containing false publicity to cheat the consumers in violation of the Law shall result in punishment according to Advertising Law of the People’s Republic of China.Any food safety regulatory authorities or institution for food inspection, food industry aociation, or consumer aociation, when recommending any food to consumers via advertising or other forms, in violation of the Law, shall be subject to confiscation of the illegal benefits by the relevant authorities, and the manager and other personnel directly responsible shall be given the punishment of recording a special demerit, demotion or removal from the office.Article 95 If any local people’s government at the county or above level fails to perform its duties pursuant to this Law in the course of supervising and administrating food safety, and food safety incidents occur with serious impact on society, both the government officials that bear responsibility and the executives directly responsible shall be punished by recording a special demerit against them or demoting or removing them from office.If the executive departments of health, agriculture, quality supervision, industry and commerce, food and drug or other executive branches of the government at the country level or above fail to perform their duties under this Law, or abuse their authority, engage in self-seeking misconduct and cause serious consequences, the authorities for supervision or appointment and dismial shall punish the people chiefly responsible, the people directly in charge and other people directly responsible by recording a special demerit or demotion;if serious consequences are caused, the people chiefly responsible, the people directly in charge and other people directly responsible shall be removed from office or dismied;the chief principal shall acknowledge the blame and resign.Article 96 Anyone in violation of this Law causing personal or property damage or other damages shall be liable for compensation.UNCLASSIFIED USDA Foreign Agricultural Service GAIN ReportCH9019 Page 21 of 21

Article 101 The food safety administration for dairy products, genetically modified foods, pig slaughtering, wines and common salt shall be in accordance with this Law;when there is separate regulations, such regulations shall apply.Article 102 The measures for administration of food safety in the railway operations shall be developed by the health administration authorities under the State Council together with other relevant departments of the State Council.The measures for administration of food safety of the special foods and self-supplied foods in the army shall be developed by the Central Military Committee according to the Law.Article 103 The State Council can make adjustments of the supervision and administration system for food safety according to the actual requirements.Article 104 This Law shall enter into force on June 1, 2009 and the Law of the People’s Republic of China on Food Hygiene shall be abolished.UNCLASSIFIED USDA Foreign Agricultural Service