Regulation on the Implementation of the Food Safety Law of the People's Republic of China (2019 Revision)

Regulation on the Implementation of the Food Safety Law of the People's Republic of China (2019 Revision) Order of the State Council of the People's Republic of China (No. 721) The Regulation on the Implementation of the Food Safety Law of the People's Republic of China, as revised and adopted at the 42nd executive meeting of the State Council on March 26, 2019, is hereby issued, and shall come into force on December 1, 2019. Premier: Li Keqiang October 11, 2019 Regulation on the Implementation of the Food Safety Law of the People's Republic of China (Issued by Order No. 557 of the State Council of the People's Republic of China on July 20, 2009, revised in accordance with the Decision of the State Council to Amend Certain Administrative Regulations on February 6, 2016, and revised and adopted at the 42nd executive meeting of the State Council on March 26, 2019) Chapter I General Provisions Article 1 This Regulation is developed in accordance with the Food Safety Law of the People's Republic of China (hereinafter referred to as the “Food Safety Law”). Article 2 Food producers and traders shall conduct production and trading activities in accordance with laws, regulations and food safety standards, establish and improve food safety management rules, and take effective measures to prevent and control food safety risks, so as to ensure food safety. Article 3 The Food Safety Commission of the State Council shall be responsible for analyzing food safety situation, conducting research and making overall planning to direct food safety work, putting forward significant policies and measures for food safety supervision and administration, and urging the implementation of food safety supervision and administration responsibilities. The food safety committee of a local people's government at or above the county level shall conduct work according to the duties prescribed by the people's government at the same level. Article 4 People's governments at or above the county level shall establish a unified and authoritative food safety supervision and administration system, and strengthen the construction of food safety supervision and administration capability. The food safety supervision and administration department and other relevant departments of a people's government at or above the county level shall perform their duties in accordance with the law, strengthen coordination and cooperation, and conduct food safety supervision and administration in an effective manner. People's governments of townships and towns and sub-district offices shall support and assist food safety supervision and administration departments of people's governments at the county level and their local offices in food safety supervision and administration in accordance with the law. Article 5 The state shall include food safety knowledge in the content of national quality education, popularize scientific knowledge and legal knowledge on food safety, and enhance the food safety awareness of the entire society. Chapter II Monitoring and Assessment of Food Safety Risks Article 6 The health administrative department of a people's government at or above the county level shall, in conjunction with the food safety supervision and administration department and other departments at the same level, establish a food safety risk monitoring and consultation mechanism, summarize and analyze risk monitoring data, conduct research on and judge food safety risks, form a food safety risk monitoring analysis report, and submit the report to the people's government at the same level. The health administrative department of a local people's government at or above the county level shall also submit the food safety risk monitoring analysis report to the health administrative department of the people's government at the next higher level. The specific measures for food safety risk monitoring and consultation shall be developed by the health administrative department of the State Council in conjunction with the food safety supervision and administration department and other departments of the State Council. Article 7 Where the food safety risk monitoring result indicates the existence of any potential food safety hazard, the food safety supervision and administration department and other departments shall, in a timely manner, notify the relevant food producer or trader if they deem it necessary upon confirmation through further investigation. The food producer or trader shall, after receiving the notice, immediately conduct self-inspection, if it finds that food fails to comply with food safety standards or there is any evidence showing that such food may damage human health, the food producer or trader shall cease production or trading, recall food and report the relevant information in accordance with the provision of Article 63 of the Food Safety Law. Article 8 Where the health administrative department, food safety supervision and administration department or any other department of the State Council finds it necessary to conduct safety assessment of pesticides, fertilizers, veterinary drugs, feeds and feed additives, among others, it shall offer a safety assessment proposal to the agriculture administrative department of the State Council. The agriculture administrative department of the State Council shall organize assessment in a timely manner, and notify the relevant department of the State Council of the assessment result. Article 9 The food safety supervision and administration department and other relevant departments of the State Council shall establish a food safety risk information exchange mechanism, and specify the content, procedures and requirements for the exchange of food safety risk information. Chapter III Food Safety Standards Article 10 The health administrative department of the State Council shall, in conjunction with the food safety supervision and administration department, agriculture administrative department and other departments of the State Council, make the planning on national food safety standards and its annual implementation plan. The health administrative department of the State Council shall publish the drafts of the planning on national food safety standards and its annual implementation plan on its website and solicit public opinions. Article 11 The health administrative department of the people's government of a province, autonomous region or municipality directly under the Central Government shall solicit public opinions on developing local food safety standards in accordance with the provision of Article 29 of the Food Safety Law. The health administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government shall submit local food safety standards to the health administrative department of the State Council for recordation within 30 working days from the date when such standards are published. If the health administrative department of the State Council finds that any recorded local food safety standards violate any law, regulation or national food safety standards, it shall order correction in a timely manner. Where local food safety standards are repealed in accordance with the law, the health administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, in a timely manner, announce the repeal thereof on its website. Article 12 Health food, formula food for special medical use, infant formula food and other special food are not local specialty food, and no local food safety standards shall be developed for them. Article 13 After food safety standards are published, food producers and traders may implement the food safety standards prior to the date of entry into force of the standards and make public the advance implementation thereof. Article 14 A food production enterprise shall not develop enterprise standards lower than the requirements of the national or local food safety standards. If a food production enterprise develops enterprise standards in which the food safety indicators are stringent than those in the national or local food safety standards, the enterprise shall submit the enterprise standards to the health administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government for recordation. A food production enterprise that develops enterprise standards shall disclose them for consultation by the public free of charge. Chapter IV Food Production and Trading Article 15 A food production or trading permit shall be valid for five years. Where the production or trading conditions of a food producer or trader change and no longer satisfy the requirements for food production or trading, the food producer or trader shall immediately take corrective measures. If necessary, the food producer or trader shall undergo licensing formalities once again in accordance with the law. Article 16 The health administrative department of the State Council shall, in a timely manner, announce the list of new food raw materials and new varieties of food additives and food-related products and the applicable national food safety standards. The health administrative department of the State Council shall, in conjunction with the food safety supervision and administration department of the State Council, update in a timely manner the list of materials which are traditionally considered as food and traditional Chinese medicines. Article 17 The food safety supervision and administration department of the State Council shall, in conjunction with the agriculture administrative department and other relevant departments of the State Council, specify the basic requirements for full process tracing of food safety, and direct food producers and traders to establish and improve the food safety traceability system through information technology means. The food safety supervision and administration department and other departments shall take the construction of traceability system for infant formula food and other food targeted at specific groups and other food with relatively high food safety risks or large sales volume as the focus of supervision and inspection. Article 18 Food producers and traders shall establish a food safety traceability system, and truthfully record and retain purchase inspection, ex-factory inspection, food sales and other information in accordance with the provisions of the Food Safety Law, so as to ensure food traceability. Article 19 The primary person in charge of a food production or trading enterprise shall be fully responsible for the food safety work of the enterprise, establish and implement the food safety responsibility system of the enterprise, strengthen supplier management, purchase inspection and ex-factory inspection, production and trading process control, food safety self-inspection, and other work. Food safety managers of the food production or trading enterprise shall assist the primary person in charge of the enterprise in managing food safety in an effective manner. Article 20 A food production or trading enterprise shall strengthen the training and assessment of its food safety managers. Food safety managers shall have a command of food safety laws, regulations, standards and professional knowledge commensurate with their positions, and shall have food safety management capabilities. The food safety supervision and administration departments shall conduct random supervision, inspection and assessment of enterprises' food safety managers. The assessment guidelines shall be developed and issued by the food safety supervision and administration department of the State Council. Article 21 Where a food or food additive producer or trader entrusts the production of food or food additives, it shall entrust the production with the producer that has obtained the food production permit or food additive production permit, supervise the production and be responsible for the safety of food or food additives produced upon entrustment. The entrusted party shall produce food in accordance with laws, regulations, food safety standards and as agreed upon in the contract, be responsible for production, and accept the supervision of the entrusting party. Article 22 Food producers and traders shall not store substances listed in the directory developed in accordance with the provision of Article 63 of this Regulation in food production and processing places. Article 23 The irradiation processing of food shall comply with national food safety standards, and the food subject to irradiation processing shall be inspected and marked in accordance with the requirements of national food safety standards. Article 24 For the storage and transport of food that has special requirements for temperature and humidity, among others, heat preservation, refrigeration or freezing equipment and facilities shall be provided and their effective operations shall be maintained. Article 25 Where a food producer or trader entrusts food storage and transport, it shall examine the capability of the entrusted party to guarantee food safety, and supervise the entrusted party's food storage and transport according to the requirements for guaranteeing food safety. The entrusted party shall guarantee that food storage and transport conditions comply with food safety requirements, and strengthen the management of food storage and transport process. Where the entrusted party accepts the entrustment of a food producer or trader to store and transport food, it shall faithfully record the names, addresses, and contact information, among others, of the entrusting party and the consignee. The records shall be kept for at least two years after the completion of storage and transport. A non-food producer or trader that engages in food storage which has special requirements for temperature and humidity, among others, shall undergo recordation formalities at the food safety supervision and administration department of the local people's government at the county level within 30 working days after obtaining its business license. Article 26 Where a catering service provider employs an entity providing centralized services of disinfecting tableware and kitchenware to provide cleaning and disinfection services, it shall check and retain a photocopy of the business license and the disinfection conformity certificate of the said entity. They shall be retained for not less than six months after the expiration of service life of disinfected tableware and kitchenware. Article 27 An entity that provides c......