GOBIERNO DE CHILE MINISTERIO D E AGRICULTURA

AGREGADURIA AGRICOLA EN CHINA

Síntesis mensual de Informaciones del Sector Agrícola en China

Beijing, Marzo 2009 No.03/2009

Informe elaborado por Juan Enrique Moya, Agregado Agrícola de Chile en China Colaboradoras: Chunge You, Wu Yaqin y Zhou , Asistentes Agregaduría Agrícola de Chile en China EMBAJADA DE CHILE EN CHINA, No. 1 DONG SI JIE, SAN LITUN 10600, BEIJING, CHINA

China: Nueva Ley de Inocuidad de Alimentos En estos días el Consejo de Estado (gabinete) de China ordenó a los gobiernos locales y a los departamentos del gobierno central prepararse de manera cuidadosa para la puesta en práctica de la recién adoptada Ley de Seguridad Alimentaria y prestar especial atención a la seguridad de los productos lácteos. La Oficina General del gabinete señaló que la ley, que entrará en vigor el primero de junio, debe ser cumplida de manera "práctica" con el fin de garantizar la seguridad en el consumo de los productos alimentarios. Esta ley, adoptada por la legislatura nacional el 28 de febrero, es considerada como un nuevo impulso al mejoramiento de la seguridad alimentaria en el país a través de una vigilancia y una supervisión más estrictas, estándares de seguridad más duros, el retiro de productos ubicados por debajo de la norma y castigos severos para los infractores. Esta ley entrará en vigor a partir del 1º de Junio de este año. También se deben establecer o revisar estándares para reforzar el control de bacterias, restos de pesticidas, metales pesados y materiales contaminantes en los productos alimentarios, así como para el uso de aditivos en los alimentos. Como este es un tema que es de interés para nuestro sector, se hace llegar una versión en inglés de este cuerpo legal.

Unofficial translation Agricultural & Commercial Office Embassy of Chile in PRC March, 12, 2009

THE PRC FOOD SAFETY LAW

FEBRUARY 29, 2009

Table of Content 1. General Provisions…………………………………………………..….2 2. Surveillance and Assessment of Food Safety Risks………..…..4 3. Food Safety Standards…………………………………………..…….5 4. Food Production and Trade………………………………………..…7 5. Inspection and Testing of Food…………………………………...16 6. Food Import and Export…………………………………………….17 7. Response to Food Safety Incidents………………………………19 8. Supervision and Administration…………………………………..21 9. Legal Liabilities……………………………………………………….23 10. Supplementary Provisions…………………………………….28 Every effort has been undertaken to ensure the accuracy of all information in this document. The Embassy of Chile accepts no liability for errors or omissions. Chapter 1: General Provisions Article (1) This Law is formulated to assure food safety, to safeguard people's life and health.

Article (2) Whenever the following activities are carried out in the territory of the People's Republic of China this Law must be observed: 1) Food production and processing (referred to as “Food Production” hereafter); food distribution and catering service (referred to as “Food Trading” hereafter); 2) Production and trading of food additives; 3) Production and trading of packing materials, vessels, detergents and disinfectants for food as well as utensils and equipment used in food production and trading (referred to as “Food-Related Products” hereafter); 4) Food additives and food-related products used by food producers and traders; 5) Safety management of food, food additives and food-related products. The quality and safety management of primary agricultural products for consumption (hereinafter referred to as “Edible Agricultural Products”) shall be in accordance with the Quality and Safety of Agricultural Products Law. However, this Law must be observed in developing quality and safety standards for edible agricultural products and releasing safety information on edible agricultural products. Article (3) Food producers and traders shall strictly follow the laws and regulations and food safety standards in their food business activities, and shall be responsible to the society and public, guarantee the food safety, accept the social supervision and assume the social responsibility. Article (4) The State Council set up a Food Safety Commission and its duties will be stipulated by the Sate Council. Department of Health Administration of the State Council assume the integrated and coordinated responsibility for food safety, risk assessment for food safety, food safety standards, release of food safety information, frame the accreditation conditions for food inspection agency and the standardized test, organizations for investigate and deal with major incident of food safety. Article (5) Local people's governments above the county level responsible for a unified, leadership, organization, coordination of the regional administration of food safety supervision and management work, Establish a system to improve the supervision and management of food safety. Should unify leadership, command of food safety emergencies event, improve the implementation of liability mechanism for food safety supervision and management and evaluate departments of administration of food safety supervision and management. In accordance with the provisions of this Act and the State Council, Local people's governments above the county level define responsibilities of food safety supervision and management for the level of health administration,

agriculture, administration, quality supervision, industry and commerce administration, food and drug supervision and management department. With the unity and under the coordination of Location People's Government Lower-level administrative regions organization established by the superior people's government department should do a good job of food safety supervision and management. Article (6) Department of Health Administration, Agricultural Administration, Quality Supervision, Industry and Commerce Administration, Food and Drug Supervision and Administration of at or above the county level should strengthen communication and close coordination, in accordance with their respective division of responsibilities, exercising their functions and powers and assume responsibility. Article (7) The related food industry associations shall strengthen their self-discipline, guide producers to produce and operate according to the law, promote the construction of credibility, pronounce and widespread the knowledge about food safety. Article (8) Civil society and community groups are encouraged to conduct food safety educational activities on understanding food safety, laws, regulations and standards, to advocate healthy diets and to raise consumer awareness of food safety and looking after their health. Food safety information, laws, regulations and standards shall be publicized by the media and the media should realize supervision by public opinion. Article (9) The State encourages and supports basic and applied food-related research, and encourages and supports food producers and traders to apply advanced technologies and good management practices in order to improve food safety. Article (10) Any institution or individual has the right to report any violation of this laws activities in food production and trade business, to know food safety information on food safety from relevant departments and to propose comments and suggestions for supervision and management of food safety.

Chapter 2: Surveillance and Assessment of Food Safety Risks Article (11) A surveillance system for food safety shall be established nationwide for surveillance over food-borne disease, food contamination and other food-related hazards to human health. The administrative departments authorized by the State Council shall establish and implement plans for the surveillance of national food safety in conjunction with other departments of the State Council. The administrative departments designated by governments of provinces, autonomous regions and municipalities directly under the central government shall establish and implement, according to the national plans for food safety surveillance and taking into consideration regional particularities, the plans and schemes for the surveillance of food safety

within their respective jurisdictions. Article (12) Administration of agriculture, quality supervision, industrial and commercial administration and the state food and drug supervision and management departments shall immediately inform the Department of Health Administration of the State Council when they get the information on food safety risk. Department of Health Administration of the State Council, in conjunction with relevant departments of the administration should be timely adjust the risk of food safety monitoring programs after verify the information Article (13) Country set up food safety risk assessment system for food, food additives in the biological, chemical and physical hazards risk assessment. Department of Health Administration of State Council is responsible for organizing the food safety risk assessment, set up the Committee of Experts, composed by experts in the field of the medicine, agriculture, food, nutrition, etc., to conduct food safety risk assessment. Experts from the food safety risk assessment committee shall be invited to participate in the safety assessment of pesticide, fertilizer, growth regulator, veterinary medicine, feed and feed additives. Food safety risk assessment should use the scientific method, in accordance with food safety risk monitoring information, scientific data and other relevant information. Article (14) Health Department of State Council should immediately organize inspection and food safety risk assessment when finds that food security may exist hidden trouble through the administration of food safety risk monitoring or upon receiving the report. Article (15) Administration of agriculture, quality supervision, industrial and commercial administration and the state food and drug supervision and management departments and other departments concerned should propose food safety risk assessment's recommendations and provide relevant information and data to the Department of Health Administration of State Council. Department of Health Administration of the State Council should timely inform the food safety risk assessment results to the concerned State Council departments. Article (16) Food safety risk assessment results are the scientific basis for development and amended food safety standards and food safety supervision and management. Food safety risk assessment results come to the conclusions of food insecurity, the State Council of Quality Supervision, Administration for Industry and Commerce and the State Food and Drug Supervision and Management Department in accordance with their respective responsibilities should immediately take appropriate measures to ensure that stop the production and operation the food, and inform consumers stop consuming; in case of needing to develop or amend the relevant national standards for food safety, Department of Health Administration of the State Council should develop or amend it immediately.

Article (17) Department of Health Administration of the State Council, in conjunction with relevant departments, should make a comprehensive analysis of the situation according to food safety risk assessment, food safety supervision and management of information. For the food that the comprehensive analysis indicates that may have a higher level of food security risks, Department of Health Administration of the State Council shall promptly make the risk of food safety alerts, and inform the public. Chapter 3: Food Safety Standards Article (18) The development of food safety standards, should be with purpose to safeguard public health and be scientific, rational, safe and reliable. Article (19) Food safety standards are enforceable standards. Except for the food safety standards, no other mandatory standards for food shall be developed. Article (20) The food safety standards shall specify: 1) The limits to the content or concentration of pathogenic micro organisms, pesticide residues, veterinary medicine residue, heavy metals, contaminants, and other substances that may be hazardous to human health in food; 2) The type, scope of application and dose of allowed food additives; 3) The nutritional ingredients requirements for staple and supplementary food exclusively for babies or other special population group. 4) The requirements for labels, identification and instructions relevant to food safety and nutrition; 5) The health requirements for food production and trading processes; 6) The quality requirements related to food safety; 7) The methods and procedures for food inspection and testing; and 8) Other particulars necessary for developing food safety standards. Article (21) Department of Health Administration of the State Council is responsible for development and publication of the National food safety standards, department of standardization administration of the State Council should provide national standards ID. The limits to the pesticide residues, veterinary medicine residue in food and its testing method should be developed by the Department of Health Administration and the Department of Agriculture Administration of the State Council.

The inspection procedures for slaughtering livestock and poultry shall be developed by the competent administrative department of the State Council in conjunction with the State Council authorized administrative department responsible for food safety risk assessment. Any national standard on relevant products involving national food safety standards shall conform to the national food safety standards. Article (22) Department of Health Administration of the State Council should integrate the existing food safety, food hygiene standards, food quality standards and relevant trade standards, unify and publish it as national standards for food safety. Before the national food safety standards under this Law are implemented, food producers and traders shall produce or trade food in accordance with the existing food safety, food hygiene standards, food quality standards and relevant trade standards. Article (23) The national food safety standards shall be reviewed and approved by the committee for evaluating national food safety standards comprising Medicine, agriculture, food, nutrition and other experts as well as representatives from the relevant departments of the State Council. National food safety standards shall be developed based on the results of food safety risk assessments and full consideration of the results of quality and safety risk assessments of agricultural products, relevant international standards and international results of food safety risk assessments. Due consideration shall also be given to a broad range of opinions of food producers, traders and customers. Article (24) Local standards may be developed if no national standard is available. The administrative departments of provinces, autonomous regions and municipalities directly under the central government shall develop or amend local food safety standards with reference to articles in this law relating to development of, or amendment to, national food safety standards, and report to the department of health administration of the State Council. Article (25) The enterprise should develop enterprise standards as the basis fot organizing production in case of no existing national or local food safety standards. Country encourages food producers to develop enterprise standards stricter than the national or local food safety standards. Enterprise standards should be reported to the provincial health administration departments for the record and be applicable at the enterprise. Article (26) Food safety standards should be available for public inspection free of charge.

Chapter 4: Food Production and Trade Article (27) Any food production or trading activities shall be subject to the food safety standards and to the following conditions: 1) Having appropriate facilities for raw material treatment and food packaging and storage that are sufficient for the variety and quantity of food to be produced or traded and making sure that environment is clean and tidy and appropriate distance has been maintained between such facilities and toxic or hazardous locations and/or other contamination or contaminating sources. 2) Having appropriate production or trading equipment and facilities that are sufficient for the variety and quantity of food to be produced or traded, and having appropriate equipment and facilities for disinfection, lighting, ventilation, anticorrosion, dust-proofing, fly-proofing and rat-proofing and drainage of wastewater and other wastes. 3) Having food safety technical professionals and management personnel, rules and regulations to assure food safety. 4) Having equipment and facility layout and operation procedures to prevent cross-contamination between the to be processed foods and the direct to eat food, raw materials and finished products and avoid food contact with toxic substances, dirt; 5) Tableware, kitchenware and containers for direct to eat foods should be washed before use, disinfection, cooking utensils, utensils should be washed after use, and maintain clean; 6) The containers, tools and equipment for food storage, transport and loading and unloading should be safe, harmless, kept clean to prevent food contamination and temperature and other special requirements to assure the food safety and the food should not be transported together with toxic and hazardous materials; 7) Direct to eat food should have a small package or use non-toxic, clean packaging materials or tableware; 8) Food production and management personnel should maintain personal hygiene, in the process of food production and operation, should wash the hands, wear clean work clothing, hats; use non-toxic, clean instrument when sale direct to eat food without the food packaging; 9) Water should be in conformity with the National Drinking Water hygiene standards; 10) Detergents, disinfectants to be used should be safe and harmless. 11) Conforming to other requirements set forth in laws and regulations.

Article (28) The production and operation of the following foods is forbidden: 1) Food produced with non-food raw material, adding non-edible chemicals or other substances that may harm human health, or with recovered food as raw materials; 2) Food which exceed food safety standard limits in content or concentration of pathogenic micro organisms, pesticide residues, animal medicine residues, heavy metals, contaminants, and other substances that in food may be hazardous to human health; 3) Staple and supplementary food exclusively for babies or other special population group, the nutritional ingredients of which fail to meet food safety standards; 4) Food which is rotten or spoilt, or has rancid fat, mildew or insects, or is contaminated or dirty, or contains foreign material, or adulterated or doped food, or displays any other organoleptic irregularity; 5) Producing or trading food containing substances expressly prohibited by the State or food expressly prohibited by the State from production and trading for disease prevention and control purposes; 6) Meat or meat products which have not been quarantined or inspected by animal health supervision authorities or fail to pass such quarantine or inspection; 7) Food contaminated by packaging materials, containers or transportation means; 8) Shelf-life exceeded food 9) Pre-packaged products without labels; 10) Food banned to production and operation by Country for the prevention of diseases, such as the special needs; 11) Producing or trading other food failing to meet food safety requirements. Article (29) Country set up licensing systems for food production and operation. Engaged in food production, food circulation, catering services, food production should obtain license to food production, food circulation and food service according to the law. A food producer that has obtained the license for food production sells the food it produces at its place of production, in which case a license for food distribution is not required; 2) the provider of catering services that has obtained the license for provision of catering services sells the food it makes and processes at its

place of catering services, in which case the license for food production and distribution if not required; 3) individual farmers that sell edible agricultural products they produce, in which case a license for food distribution is not required. Food production and processing of small workshops and food vendors engaged in food production and operation activities, should be in conformity with the provisions of this law that are sufficient for the scale and the conditions, assure the food is hygiene, non-toxic, harmless, the relevant departments should make strengthen supervision and management. Food vendor administration measures shall be developed by the standing committees of people’s congresses of provincial, autonomous region and municipalities directly under the central government, pursuant to this Law. Article (30) Local people’s governments above county level shall take actions to encourage food vendors to trade in fixed marketplaces, such as central trading markets or shops. Article (31) The department of Quality supervision, industry and commerce administration, food and drug supervision and management department, at or above the county level, shall review materials set forth in Article 27 I-IV and submitted by the applicants within their respective duties and responsibilities, and check the places of production and/or trading of the applicants as necessary. Any applicant that meets the conditions shall be granted the license. Any applicant failing to meet the licensing conditions will be rejected and given a written explanation of the reasons. Article (32) Food production and operation enterprises should establish and improve the unit's food safety management system, strengthen the training of staff on food safety knowledge, with full-time or part-time food safety management, to do a good job on the inspection on food production and operation, the food production and operating activities should be In accordance with the law. Article (33) The State encourages food producers and operator to conform to good manufacturing practices, implement the Hazard Analysis and Critical Control Point System to improve food safety management. The certification body should implement follow-up survey to the food producers and operator which conformed to good manufacturing practices, implement the Hazard Analysis and Critical Control Point System; in case of the enterprises which no longer meets the certification requirements, the certification body should revoke the certification in accordance with the law and promptly inform the relevant quality supervision, industry and commerce administration management, food and drug supervision and management department and to the public. Certification body does not collect any fees for implementation follow-up survey. Article (34) Producers and traders of food shall establish and implement an

employee health management system. No person who has a digestive tract infection including dysentery, typhus, viral hepatitis, active pulmonary tuberculosis, purulent or weeping skin diseases that adversely affect food safety shall work in direct contact with food for consumption. Food production and management personnel should have an annual health check, and should obtain health certificates before they could take part in the work. Article (35) Consumption of agricultural productions producers should use the pesticides, fertilizers, growth regulators, veterinary medicine, feed and feed additives and other agricultural inputs in accordance with food safety standards and the relevant provisions of National. Enterprises of consumption of agricultural productions and specialized cooperative economic organizations of farmers should be set up record-keeping system of agricultural production for human consumption. Department of agricultural administration at or above the county level, should strengthen the management and guidance for the use of agricultural inputs, establish and improve the system for the safe use of agricultural input. Article (36) To purchase food ingredients, food additives, food-related products, the food producers should check suppliers product licensing and certification documents. For that food raw materials that can not provide proof of qualification, should be tested in accordance with the food safety standards. Can not purchase or use food ingredients, food additives, food-related products which not in accordance with the food safety standards. Food production enterprises should set up a purchase inspection record-keeping system for the ingredients, food additives, food-related products. Accurately record food ingredients, food additives, food-related products’ name, specifications, quantity, supplier names and contact details, purchase date etc. The purchase inspection records of food ingredients, food additives, food-related products should be true, and the retention period should not less than two years Article (37) Food producers shall establish and maintain records of outgoing food inspections, check inspection certificates and the safety condition of outgoing food. They shall correctly record such information as the name, specification, quantity, production date, batch number, inspection certificate number, purchaser name and contact information, and sale date. The food leave factory inspection records should be true, and the retention period should not less than two years. Article (38) Producer of food, food additives and food related products should test the production of food, food additives and food related products in accordance with food safety standards. After passing the inspection can be factory or sales.

Article (39) To Procurement food, the food business operators should check suppliers’ license and food qualified documents. Food enterprises should set up a record-keeping system for the food purchase inspection. Accurately record the names of food, specifications, quantity, and production batch number, durability, suppliers name and contact details, purchase date etc. Record food purchase inspection should be true, and the retention period should not be less than two years. The food ventures that use the uniform distribution mode can check suppliers’ license and food qualified documents by the corporate headquarters. To record food purchases inspection Article (40) Food operators should storage the food in accordance with the requirements of food safety; regular inspect the food inventory; timely clean-up metamorphism, or more than shelf-life of food. Article (41) Food operators who storage bulk food should marked in the storage location the food's name, date of manufacture, durability, producer name and contacts etc. Food operators who sells bulk food should marked in the food’s containers, packaging food's name, date of manufacture, durability, producer name and contacts etc. Article (42) Pre-packaged food shall have a label on its package. The label shall indicate: 1) The name, specification, net content and date of production; 2) Ingredients or formulation; 3) Producer name, address and contact information; 4) Shelf life; 5) Product standard(s) code; 6) Storage conditions; 7) Common name in the National standards of food additives used; 8) Food Production License Number; 9) Other information to be indicated in accordance with applicable legislation, regulation and national food safety standards.

The labels on staple and supplementary food exclusively for babies or other specific population groups shall indicate the main nutritional ingredients and their contents. Article (43) The country carry out permission system for the production of food additives. The conditions and procedures to apply for the permission for the production of food additives should be executed in accordance with the provisions of country related industrial products production license management. Article (44) The unit or individual who applies for taking advantage of new food ingredients to engaged in food production or to engage in new varieties of food additives, food related products for the production of new varieties events should submit the relevant product safety evaluation materials to the State Health Administration Department. The State Health Administration Department should review, within sixty days from the date of receipt of the application, the safety assessment of materials of the related products. To meet food safety requirements, decision to grant permission in accordance with the law and be published. That does not meet food safety requirements, decided not to license with a written explanation Article (45) Department of Health Administration of the State Council should be based on technical necessity and food safety risk assessment results and revise the varieties of food additives, the use of the scope and the standard dosage without delay. Article (46) The food producers should use the food additives according to the food safety standards on food additives varieties, use, dosage requirements. Shall not be used in food production outside of food additives and other chemical substances may harm human health. Article (47) Food additives must have a label, instructions and packaging. The instructions or label must include the information required in Article 39.1~6, 8 and 9, and the scope of use, dosage and application of the food additive, with the words “Food Additive” indicated on the label. Article (48) The label and instructions of food and food additives shall not contain false, exaggerated; shall not be involved in disease prevention, treatment functional. The producer shall be responsible for the contents specified on the label and instructions. Labels and instructions for food and food additives shall be made clear and conspicuous. Food and food additives that not match their labels, instructions, can not be listed for sale

Article (49) Food operators should sell pre-packaged foods in accordance with the requirements of the warning signs, alert description or notes marked on the food labels. Article (50) Drugs should not be added in food; however, the substances that traditionally are not only food but also Chinese herbal medicines can be added. That is food and also is Chinese herbal medicines. That is food and also is Chinese herbal medicines is enacted and released by the State Council of Health Administration Department. Article (51) Country supervises strictly the foods claimed with a specific health function. The relevant supervision and management departments should perform their duties and assume the responsibility according to the law. The concrete management rules are set by the State Council. The foods that are claimed with a specific health function shall not cause acute, sub-acute or chronic harm to human. Their labels and instructions may not be involved in disease prevention o function of treatment; the content must be true and shall set forth the appropriate groups, inappropriate groups, components of efficacy o symbolic components and its content, etc... Product functions and components must be consistent with the label and instructions. Article (52) Central trading market operators, stall leasers, and organizers of trade fairs shall review the admitted food traders’ food distribution and catering service permits. They shall specify the admitted food traders’ food safety management responsibilities. They shall regularly inspect the operating environment and conditions of the admitted food traders. Immediately upon detection, they shall prevent any trading of unsafe food or any other activities in breach of this Law and promptly report the incident to the local industrial and commercial administrative departments or the food and drug supervision and management departments at the county level.

If central trading market operators, stall leasers, and organizers of trade fairs fail to fulfill the obligations stipulated in the preceding paragraph, any food safety incident caused by any food traded in such marketplaces will result in joint and several liabilities of them.

Article (53) A food recall system shall be established. Where a food producer detects production of any unsafe food, the food producer shall immediately stop production, recall such food released to the market, and record all recalls. Where a food trader detects the trade of any unsafe food, the food trader shall immediately stop trading, notify relevant producers and traders to cease production and trade of such food, notify consumers to cease consumption of such food, and record all notifications. Food producers should immediately recall if he considers so.

Food producers and traders shall take remedial, harmless treatment, destruction and other measures, Report to at or above the county Department of Quality Supervision the situation of the food recall. Food production operator in accordance with the provisions of this article did not recall or stop operating do not meet food safety standards, above the county level quality supervision, industry and commerce administration, food and drug supervision and management department can order to recall or cease operating . Article (54) Food advertisements shall provide truthful information and shall not include any false or exaggerated information or any statement of functions for treating any disease. Food Safety Supervision and Management Department, or assume the responsibilities of food inspection agency, food industry associations, consumer associations should not recommend to consumers any food by ads or other forms. Article (55) Social groups or other organizations, individuals in the false ads recommend to consumers the food, which damage legitimate rights and interests of consumers. The food production operators are jointly and severally liable. Article (56) Local governments at all levels should encourage large-scale production and food chain management, distribution. Chapter 5: Inspection and Testing of Food Article (57) Food inspection and testing agencies accredited and/or recognized by the State Council administrative department for the supervision and administration of certification and accreditation may perform food inspection or testing. However, except as otherwise provided in law. The conditions that qualify such agencies for food inspection and testing as well as inspection and test specifications shall be developed by State Council authorized department. Food inspection and testing agencies which have been accredited and/or recognized by the State Council competent department before the implementation of this Law may continue to perform inspection and/or testing of food in accordance with this Law. Article (58) Food inspection and testing shall be independently conducted by food inspection and testing agency designated inspectors. The inspectors shall inspect and test food in accordance with the applicable legislation, regulations, food safety standards and inspection specifications. The inspectors shall act scientifically and conform to professional ethics, and assure objective and fair inspection data and conclusions, and shall not issue any false inspection report.

Article (59) Food inspection agencies and inspectors shall be responsible for food inspection and testing. The food inspection report shall bear the official seal of the food inspection agency and the signature or seal of the inspector. The food inspection agency and inspector shall be held responsible and liable for the food inspection report issued. Article (60) Food safety supervision and management department should not do the implementation of the exemption with any food. Above the county level quality supervision, industry and commerce administration, food and drug supervision and management department should do regular or irregular food sample testing. Carry out random testing, samples should be taken buy. Not charge inspection fees and any other costs. During the Law enforcement, above the county level quality supervision, industry and commerce administration, food and drug supervision and management department should do the food inspection. Consistent with the provisions of this Law shall be entrusted to the food inspection agency, and to pay related costs. If there is objection to the conclusions of the examination can be carried out according to law a retest. Article (61) Food production enterprises can test their own food; can also be commissioned in line with the provisions of this Law of the food inspection agency to carry out the inspection. Organizations such as the food industry associations, or consumers who need the food inspection agency commissioned to carry out inspection of food, should commission the food inspection agencies which are in conformity with the provisions of this law. Chapter 6: Food Import and Export Article (62) Imported food, food additives and food-related products shall comply with China’s national food safety standards. After passing inspection by the entry-exit inspection and quarantine institutions, the imported food should be released by the Customs with certificate issued by the entry-exit inspection and quarantine institutions. Article (63) Importing food without country safety standards, or importing for the first time new varieties of food additives, food-related products, the importers should be provided to health administration department of the State Council an application and submit the relevant assessment of the safety materials. In accordance with the provisions of 44th Article of this Act the department of Health Administration of the State Council will decide whether to grant permission. And timely introduce corresponding national standards for food safety.

Article (64) Where any food safety incident that occurs outside China may impact within China, or any imported food is detected with a serious food safety problem, the State Council administrative department for exit-entry inspection and quarantine shall promptly take action to avert risk and notify administrative departments for supervision and Health administration, agriculture administration, industrial and commercial administration and the State Food and Drug Supervision and Management Department. The notified departments shall promptly take appropriate action. Article (65) Exporters or agents exporting food to China shall file a record with the State Council administrative department for exit-entry inspection and quarantine. Overseas food producers exporting food to China shall apply for registration with the State Council administrative department for exit-entry inspection and quarantine. The State Council administrative department for exit-entry inspection and quarantine shall regularly release the list of exporters and agents and registered overseas food producers. Article (66) Imported pre-packaged food shall have Chinese labels and Chinese instructions. Such labels and instructions shall conform to this Law and other applicable Chinese legislation and regulations and national food safety standards. Labels and instructions shall indicate the food place of origin and the domestic agent’s name, address and contact information. Pre-packaged food without Chinese labels or Chinese instructions or whose labels and instructions fail to meet requirements shall not be imported. Article (67) Food importers shall establish and maintain import and sales records, correctly record such information as the product name, specification, quantity, production date, production or import batch number, shelf life, exporter name and contact information, purchaser name and contact information, and delivery date. The food import and sales records shall not be altered or forged, and shall be maintained for at least two years. Article (68) Food to be exported shall be monitored and sampled by the authority for exit-entry inspection and quarantine. Customs shall only allow products with the inspection certificate issued by the authority for exit-entry inspection and quarantine to be imported. Producers of exported food, plantations and breeding farms for food raw material for exported food shall file a record with the State Council administrative department for exit-entry inspection and quarantine. Article (69) The State Council administrative department for exit-entry inspection and quarantine shall collect and summarize information on the safety of imported and exported food and notify the same to all relevant departments, institutions and enterprises.

The State Council administrative department for exit-entry inspection and quarantine shall establish and publicize good and bad records, as the case may be, of importers, exporters, and producers of exported food. Importers, exporters, or producers of exported food with bad records shall be subject to more stringent inspection and quarantine of imported or exported food. Chapter 7: Response to Food Safety Incidents

Article (70) The State Council shall make emergency plans for national food safety incidents.

Governments at the county level or above shall make emergency response plans for food safety incidents within their respective jurisdictions based on the particulars of the locality and the superior government’s emergency response plans and shall submit their plans to their superior government agency to record.

Food producers and traders shall make individual food safety incidents response plans. They shall regularly inspect the implementation of food safety measures to promptly avoid potential food safety incidents.

Article (71) The organization executive where a food safety incident has occurred, shall promptly take effective actions to control the extent of the incident. Accident sick units and patient receiving treatment units should report the incident in a timely manner to health administration departments at the county level. If agricultural administration, quality supervision, industry and commerce administration, food and drug supervision and management departments find food safety incidents in the day-to-day supervision and management, or receive reports of food safety incidents, shall inform immediately to the health administration department. In the case of a major food safety incident, received the report the county health administration department shall report in accordance with the provisions to the department of health administration of the People's Government and the superior level People's Government. The health administration departments of the county-level People's Government and the higher people's government shall report to above in accordance with the regulations. Any unit or individual may not conceal, false or delay the report of the food safety incidents, may either destroy relevant evidence. Article (72) Health administration department at the county level or above received reports of food safety incident, shall immediately concern with the administration of agriculture, quality supervision, industry and commerce administration, food and drug supervision and management departments to

handle the investigation and take the following measures to prevent or mitigate the harm to society: 1) Carrying out emergency rescue work, health administration departments shall organize the treatment immediately to injury personal resulted due to food safety incidents; 2) Sealing and testing immediately food and raw materials which may lead to chive may lead to food safety incidents of food and raw materials, and immediately carry out testing; Ordering producers and operators to recall, stop operating of, and destroy in accordance with the provisions of Article (53) of this law the food and raw materials confirmed contaminated; 3) Sealing contaminated food tools and appliances, and ordering to carry out cleansing and disinfection; 4) Do good job in the publication of information, publishing according to the law on food safety incidents and the dealing with situation, and making explanations about possible hazards. The event of a major food safety incidents, people's government above the county level should set up immediately a food safety incident command disposal, start contingency plans for disposal in accordance with the provisions of the preceding paragraph.

Article (73) In the case of major food safety accidents, health administrative department of the people's government above the municipal level divided into districts should investigate immediately the accident duty together with the relevant departments, urge relevant departments to perform their duties, and submit the report of investigation and treatment of the responsibility for the accident to the people's government at the same level.

Major food safety accidents involving two or more provinces, autonomous regions or municipalities, the administrative department of the State Council should organize the accident responsibility investigation in accordance with the hygiene provisions in the preceding terms.

Article (74) Food safety incidents happened, disease prevention and control institutions at and above the county level should assist health administration department and relevant departments to carry out hygiene treatment on the scene of the accident, and carry out epidemiological investigations to factors related to the safety incident.

Article (75) Investigating food safety incidents, apart from identifying the responsibility of the accident units, should also identify the cases of staff dereliction of duty of the supervision and management departments and the certification agencies.

Chapter 8: Supervision and Administration

Article (76) Local people's governments at or above the county level should organize, health administration, agricultural administration, quality supervision, industry and commerce administration, supervision and management of the food and drug administration departments at the same level to introduce the annual plan of supervision and management for the region's food safety, and organize to carry out work in accordance with the annual plans. Article (77) The quality supervision, industry and commerce administration, food and drug supervision and management departments at or above the county level fulfill their respective food safety supervision and management responsibilities, having the right to take the following measures: 1) Entering production and trading sites for field inspection; 2) Carrying out sample tests on producing and trading foods; 3) Accessing and copying the contracts, instruments, account books and other relevant documents; 4) Attaching and arresting the food proved by evidence not meeting food safety standards, illegal used food ingredients, food additives, food-related products, as well as contaminated tools and equipments or used for the illegal production and trade activities; 5) Sealing illegal food production and operation activities sites. Agricultural administration department at or above the county level should conduct supervision and management of agricultural products for human consumption according to duties provided in the Agricultural Products Quality and Safety Law. Article (78) The quality supervision, industry and commerce administration, food and drug supervision and management department at and above the county level, should record the circumstances and the outcome of treatment during the supervision and inspection on food producers and operators. And the records of supervision and inspection should be signed by the supervision and inspection personal and operators, and then be archived.

Article (79) The quality supervision, industry and commerce administration, food and drug supervision and management departments at or above the county level should establish and maintain food safety credit records for food producers and traders, record issuance of licenses, results of daily supervision and inspection, and punishment of illegal activities; increase the frequency of supervising and inspecting food producers and traders with bad credit records in line with such food safety credit records.

Article (80) The health administration, quality supervision, industry and commerce administration, food and drug supervision and management departments at or above the county level, upon receiving any inquiry, complaint or information from a whistle-blower, accept, promptly verify, and deal with such an inquiry, complaint or other information and reply. These departments shall transfer matters beyond their duty and authority to other departments empowered to deal with such matters, which shall act immediately and not shift responsibility to others; regarding food safety incidents, they should be dealt with in accordance with the relevant provisions of Chapter 7 of this Law.

Article (81) The health administration, quality supervision, industry and commerce administration, food and drug supervision and management departments at or above the county level shall oversee and administer food safety according to their statutory authority and procedures. They shall not impose two or more administrative penalty fines on the same illegal food producer or trader activity. Anyone suspected of activities that require criminal investigation shall be transferred to public security authorities according to the law. Article (82) National Unity set up food safety information release system. The following information by the State Council announced a unified Department of Health Administration: The State shall establish a unified food safety information system. The following information shall be centrally disclosed by State Council authorized health administrative departments:

1) General situation of national food safety; 2) Food safety risk assessment information and food safety risk warning information; 3) Major food safety incidents and the treatment information; 4) Other important food safety information and the information the State Department identified necessary to publish unified. The information set forth in the term 2) and 3) of the previous paragraph may, if its impact is limited to particular regions, be disclosed by the health administrative departments designated by the people’s governments of relevant provinces, autonomous regions and municipalities directly under the central government. The agricultural administration, quality supervision, industry and commerce administration, food and drug supervision and management departments at or above the county level shall disclose information on daily supervision and administration of food safety in accordance with their duties and responsibilities.

Food safety supervision and management departments shall disclose information on an accurate, timely, and objective basis,

Article (83) The local health administration, agricultural administration, quality supervision, industry and commerce administration, food and drug supervision and management departments at or above the county level, shall, immediately upon receiving information requiring central disclosure pursuant to Article 82(1), report to their superior departments, which then shall immediately report to the hygiene administrative department of the State Council, and, if necessary, they may directly report to the hygiene administrative department of the State Council.

The health administration, agricultural administration, quality supervision, industry and commerce administration, food and drug supervision and management departments at or above the county must notify each other of any food safety related information.

Chapter 9: Legal Liabilities

Article (84) Violation of this Law, unauthorized engaging in food production and operation activities, or unauthorized production of food additives should be punished by the competent department in accordance with their respective division of responsibilities, confiscate the illegal income, illegal production and trade of food, food additives and for the illegal production and management tools, equipment, raw materials and other items; For the illegal production and trade of food, food additive value less than the amount of RMB 10,000 yuan, the penalty should be between RMB 2,000 yuan and RMB 50,000 yuan, and for the value which is above RMB 10,000 yuan, the penalty should be between 5 to 10 times of the value of the good .

Article (85) Violation of the provisions of this Law, in any of the following cases, the competent departments shall, in accordance with their respective division of responsibilities, confiscate the illegal income, illegal produced and traded food and the instruments, equipments, raw materials and other items for the illegal production and operation; For the illegal production and operation of food of value less than the amount of RMB 10,000 yuan, the fine should be between RMB 2000 yuan and RMB 50,000 yuan; And for the value above the amount of RMB 10,000 yuan, the fine should be between 5 to 10 times of the value of the good; For serious cases, the license shall be revoked: 1) Using non-food raw materials to produce food or, adding chemicals other than food additives in foods, or using recycling food as raw materials to produce food;

2) Producing or trading food which exceeds the national standard limits for content or concentration of pathogenic micro organisms, pesticide residues, animal medicine residues, heavy metals, contaminants, and other substances that may be hazardous to human health in food;

3) Producing and trading primary and secondary food exclusively for infants and young children and other specific groups of which nutrients do not meet food safety standards;

4) Trading food which is rotten or spoilt, has rancid fat, mildew or insects, is contaminated or dirty, or contains foreign material or displays any other organoleptic irregularity;

5) Trading meat of any bird, livestock, beast, or waterborne animal which has been killed by disease, poison or any unidentified cause, or producing or trading products from meat of any bird, livestock, beast, or waterborne animal which has been killed by disease, poison or any unidentified cause;

6) Trading meat or meat products which have not been quarantined or inspected by the authorities for supervision of animal health or have failed to pass such quarantine or inspection;

7) Trading food out of the shelf-life;

8) Producing or trading food expressly prohibited by the State from production and trading for disease prevention and control purposes;

9) Using new food ingredients produce food or engaging the production of new varieties of food additives, new varieties of food related products but without safety evaluation; 10) Food producers or traders still refuses to recall or cease operations after the relevant director department ordered to recall or stop operating food that do not meet food safety standards; Article (86) Violation of the provisions of this Law, in any of the following cases, the competent departments shall, in accordance with their respective division of responsibilities, confiscate the illegal income, illegal produced and traded food and the instruments, equipments, raw materials and other items for the illegal production and operation; For the illegal production and operation of food of value less than the amount of RMB 10,000 yuan, the fine should be between RMB 2.000 yuan and RMB 50,000 yuan; And for the value above the amount of RMB10,000, the fine should be between 2 to 5 times of the value of the good; For serious cases, the license shall be revoked:

1) Trading food contaminated by packaging materials, containers or transportation tools;

2) No tag production and management of pre-packaged food, , or labeling, instructions do not meet the provisions of this Law of the food, food additives; Producing or trading pre-packaged food and food additives without labels, or food and food additives whose labels and instructions failing to meet food safety requirements set forth in this Law;

3) Food producers procure, use food ingredients, food additives and food-related products failing to meet food safety standards set forth in this Law;

4) Food producers and traders add drugs in food.

Article (87) Violation of the provisions of this Law, in any of the following cases, the competent departments shall order immediate correction and give a warning in accordance with their respective division of responsibilities,; If refused to make corrections, impose a fine between RMB 2,000 yuan and RMB 20,000 yuan; In serious circumstances, order suspension of production or operations to allow for corrective action, even order revocation of the license:

1) The food producer or trader fails to carry out testing to the procured food raw materials, produced food, food additives, and food-related products;

2) The food producer or trader fails to establish and implement the inspection record system and the factory inspection record system;

3) The food producer or trader fails to file its established enterprise food safety standards for record pursuant to this Law;

4) The food producer or trader fails to store or sell food or manage food in storage pursuant to this Law;

5) The food producer or trader fails to inspect the food safety license or relevant certificates of incoming products pursuant to this Law;

6) The label or instructions of the food or food additives produced refers to the function of the food in preventing, treating any disease;

7) The food producer or trader employs persons suffering from any of the diseases set forth in Article 34 of this Law to undertake any work which involves direct contact with food for consumption.

Article (88) If the organization where any food safety incident occurs fails to handle and report such incident pursuant to this Law, the relevant administrative department shall, according to their duties and responsibilities, 1) order immediate correction and give a warning; 2) order suspension of production or operations, and impose a fine between RMB 2,000 yuan and RMB 100,000 if evidence is destroyed in violation of this law; and 3) in serious circumstances, order revocation of the license by the original issuing department.

Article (89) In any of the following cases, punishment shall be imposed pursuant to Article 85:

1) Food that does not meet the China’s national food safety standards is imported;

2) Importing food which is not yet covered by existing national standards for food safety, or importing for the first time new types of food additives and/or food-related products, but not examined or approved by safety evaluation;

3) The exporter fails to export food in compliance with this Law. Any importer

failing to establish and implement the food import and sale records system shall be punished pursuant to Article 81.

Any importer failing to establish and implement the food import and sale records system shall be punished pursuant to Article 87 of this Law.

Article (90) If any operators of central trading markets, stall leasers, and organizers of trade fair permit food traders without a license to sell food in the market in violation of this Law, or fails to perform their inspection or reporting obligations, the relevant administrative departments shall impose a fine between RMB 2,000 yuan and RMB 50,000 yuan according to their respective duties and responsibilities, and, if serious consequences are caused, order suspension of operations, and order revocation of its license by the original issuer.

Article (91) Any violation of this Law, which not in accordance with the requirements of food transport, in accordance with their responsibilities of respective division, the competent department should order correction and give a warning, if the correction is refused, order suspension of operations for correction and impose a fine between RMB 20,000 and RMB 500,000, and in serious circumstances, order revocation of its license by the original issuing department.

Article (92) Executives of any organization for food production, distribution or provision for catering service, whose license has been revoked shall not engaged in management of food production or trading in 5 years.

Where any food producer or trader engages any person prohibited from management of food production or trading to undertake management work, its license shall be revoked by the original issuing department. Article (93) Any food inspection agency, food inspectors issues false inspection reports in violation of this Law, the accreditation administration or any other department granting its qualification shall revoke its certificate of qualification, in accordance with the law, the direct responsible of the inspection agency's and the food inspectors personnel should be removed from office or dismissed.

Any food inspection personnel removed from office or dismissed in violation of this Law is prohibited from any food inspection work within ten (10) years thereafter, since the date of the penalty or punishment is finished to decide. Any food inspection agency employing any person prohibited from food inspection work will be subject to revocation of its certificate of qualification by the accreditation administration or any other department granting its qualification.

Article (94) Any advertisements that provide false information and deceive the consumer, in violation of this law, shall be punished in accordance with the Advertisement Law.

If any food safety supervision and management department, or food inspection agency, food industry association, or consumer association recommends food to consumers by advertisement or other forms in violation of the provisions of this Law, the relevant competent authorities shall confiscate the illegal income, and punish both the directly responsible director personnel and other direct responsible personnel by recording a special demerit against them or demoting or removing them from office.

Article (95) If any local people’s government at or above the county level fails to perform its duties pursuant to this Law in the course of supervising and administrating food safety, and food safety incident with serious impact on society occurs in the administrative region, both the directly responsible director personnel and other direct responsible personnel shall be punished recording a special demerit against them or demoting or removing them from office or expel.

If, in violation of the provisions of this Law, any health administration, agriculture, administration, quality supervision, industry and commerce administration, food and drug supervision and management department fails to perform their duties under this Law, or abuse their authority, derelict their duty, or practice favoritism, both shall punish the people directly chiefly responsible and other people directly responsible by recording a special demerit or demotion; if serious consequences are caused, they shall be removed from office or dismissed; the mainly responsible people should take the blame to resign.

Article (96) Any violation of this Law and causing personal injury, property damage loss or other losses shall be liable to pay compensation according to law.

If any food producer or trader produces the food that do not meet safety standards or sells the food that do not meet safety standards, the consumers may claim damages ten times of the price paid in addition to compensation for loss incurred to the consumers.

Article (97) Any violation of the provisions of this Law that request bear the civil liability and pay a fine, while its property is not sufficient to pay all at the same time, firstly should bear civil liability.

Article (98) Any criminal activity in violation of this Law should be subject to criminal prosecution pursuant to the Criminal Law. Chapter 10: Supplementary Provisions Article (99) For the purpose of this Law, the following terms shall have the meaning defined hereunder:

Food means any refined product and raw materials that is suitable for eating and/or drinking, and substance which traditionally is not only food but also drug, but excluding substances used for the purpose of treatment.

Food Safety means the assurance that the food is nontoxic, harmless, and compliant with reasonable nutritional requirement, and will not cause any acute, sub-acute or chronic hazards to human health.

Pre-packaged Food means food which is quantitatively prepackaged or made in containers or packaging materials.

Food Additive means any synthetic or natural substance used to improve the quality, color, fragrance, flavor of food, and used to add to the food or put together with the food for processing technology requirements. Food Container and Packaging Material means the products made of paper, bamboo, wood, metal, porcelain, plastic, rubber, natural fiber, chemical fiber, or glass and used to contain food or additives, or coating in direct contact with food or additives.

Food Tools and Devices mean machines, pipes, conveyer belts, containers, appliances, tableware and other objects that have direct contact with food or additives during production, distribution and use of food or additives.

Food Detergent and Disinfectant mean substances that are directly used to sterilize or wash food, food tools and devices, or food containers and packaging materials. For food detergents, disinfectants, refers directly to washing or disinfection of food, tableware, as well as direct contact with food instrument, equipment or food packaging materials and containers of the material.

Shelf Life means the period prior to the “best before” date when the pre-packaged food remains in good quality under the storage conditions indicated on the label.

Food Borne Disease means any infectious, toxic or other disease caused by pathogenic bacteria which enter the body through food.

Food Poisoning means acute, sub-acute or other food-borne diseases that are caused by eating food contaminated by or containing poisonous or hazardous substances.

Food Safety Incident means any incident that may be caused by food poisoning, food borne diseases, food contamination, or other incidents arising from food and hazardous to human health.

Article (100) If the food producer or trader has received the relevant license before the execution of this Law, such a license shall remain valid until expiration thereof.

Article (101) The measures for food safety administration of dairy products, transgenic food, pig slaughtering, wines and liquors, and common salt shall apply this Law; laws and administrative regulations as otherwise provided, should be in accordance with its provisions.

Article (102) The food safety management approaches in the of railway operation shall be established by health administrative department of the State Council together with relevant departments of the State Council in accordance with this Law.

The food safety management approaches for army special food and self-supply food shall be established by the Central Military Commission in accordance with this Law.

Article (103) The State Council can make adjustments to the food safety supervision and management system according to actual needs.

Article (104) This Law shall enter into force on June 1, 2009. And the Food Sanitation Law of the People’s Republic of China (dated October 30, 1995) shall be repealed at the same time.