General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China "Announcement on the Supervision and Inspection Regulations for Food Production and Processing Enterprises to Implement the Main Responsibility for Quality and Safety" (General Administration Announcement No. 119 of 2009)

　　Announcement on the Implementation of Quality and Safety by Food Production and Processing Enterprises

　　Regulations on the Supervision and Inspection of Main Responsibilities

　　According to the "Food Safety Law of the People's Republic of China", the "Implementation Regulations of the Food Safety Law of the People's Republic of China", the "Special Provisions of the State Council on Strengthening the Supervision and Management of Food and Other Product Safety" and other relevant laws and regulations, to urge food production and processing enterprises to fulfill their main responsibilities for quality and safety, standardize the supervision and inspection work of food production and processing enterprises, and ensure food quality and safety, the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China has formulated the "Regulations on the Supervision and Inspection of the Implementation of Main Responsibilities for Quality and Safety by Food Production and Processing Enterprises", which will be implemented from March 1, 2010. If any problems occur during implementation, please promptly report to the General Administration of Quality Supervision, Inspection and Quarantine.

　　Hereby announced.

　　December 23, 2009

　　Implementation of Main Responsibilities for Quality and Safety by Food Production and Processing Enterprises

　　Supervision and Inspection Regulations

　　Chapter 1 General Provisions

　　Article 1 To urge food production and processing enterprises (hereinafter referred to as "enterprises") to fulfill their main responsibilities for quality and safety, standardize the supervision and inspection work of enterprise quality and safety, and ensure food quality and safety, these regulations are formulated in accordance with the "Food Safety Law of the People's Republic of China" and its implementation regulations, the "Special Provisions of the State Council on Strengthening the Supervision and Management of Food and Other Product Safety" and other relevant laws and regulations.

　　Article 2 The enterprises referred to in these regulations are food producers who have obtained food production licenses in accordance with the "Food Safety Law of the People's Republic of China" and other legal provisions.

　　Article 3 The local quality and technical supervision departments at or above the county level shall, by listening to enterprise reports, reviewing enterprise records, questioning enterprise employees, inspecting production sites, testing enterprise products and the food raw materials, food additives, and food-related products used, and investigating enterprise stakeholders, supervise and inspect the enterprise's compliance with relevant laws, regulations, and standards (except for on-site inspections during the enterprise's application for food production licenses) in accordance with the law, and these regulations shall apply.

　　Article 4 The General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (hereinafter referred to as "General Administration of Quality Supervision") is responsible for formulating (revising) the regulations on the supervision and inspection of enterprises' implementation of main responsibilities for quality and safety, and guiding and inspecting the provincial quality and technical supervision departments in implementing supervision and inspection according to these regulations.

　　The local quality and technical supervision departments at or above the county level are responsible for the supervision and inspection of enterprises within their jurisdiction within their authority, and higher-level departments shall guide and inspect the implementation of supervision and inspection by lower-level departments according to these regulations.

　　Article 5 The local quality and technical supervision departments at or above the county level shall provide guarantees for the supervision and inspection work of enterprises' implementation of main responsibilities for quality and safety.

　　Article 6 The supervision and inspection work shall follow the principles of scientific fairness, openness and transparency, legal procedures, convenience, and efficiency.

　　Chapter 2 Enterprises' Main Responsibilities for Quality and Safety

　　Article 7 Enterprises shall maintain consistency of qualifications.

　　(1) The actual places where enterprises produce food and the scope of food production shall be consistent with the contents of the food production license;

　　(2) If there are changes in production conditions, inspection methods, production technology, or processes during the validity period of the food production license, enterprises shall report according to regulations;

　　(3) The enterprise name stated on the food production license shall be consistent with the business license.

　　Article 8 Enterprises shall establish a system for recording incoming goods inspection.

　　(1) Enterprises shall establish and keep records of incoming goods inspection for food raw materials, food additives, and food-related products purchased, request copies of licenses from suppliers (referring to those that should obtain licenses according to relevant laws and regulations), and obtain certificates of conformity corresponding to the purchased batch products;

　　(2) For food raw materials supplied without valid certificates of conformity, enterprises shall inspect them according to food safety standards or entrust inspection and keep inspection records;

　　(3) Enterprises purchasing imported food raw materials, food additives, and food-related products requiring statutory inspection shall request valid inspection and quarantine certificates from suppliers;

　　(4) The varieties of food raw materials, food additives, and food-related products used in food production and processing shall be consistent with the contents of the incoming goods inspection records.

　　Article 9 Enterprises shall establish a production process control system.

　　(1) Enterprises shall regularly self-inspect the cleanliness and hygiene of the factory environment, production sites, and facilities, and keep self-inspection records;

　　(2) Enterprises shall regularly maintain, clean, and disinfect essential production equipment and facilities, keep records, and establish and keep records of production suspension and resumption as well as safety control records of production equipment and facilities during resumption;

　　(3) Enterprises shall establish and keep records of storage, custody, issuance, and outbound of various purchased food raw materials, food additives, and food-related products;

　　(4) Enterprises shall establish and keep production input records, including types of inputs, product names, production dates or batch numbers, quantities used, etc.;

　　(5) Enterprises shall establish and keep control records of critical control points in the production and processing process, including necessary semi-finished product inspection records, temperature control, workshop cleanliness control, etc.;

　　(6) At the production site, enterprises shall avoid cross-contamination of people and materials, avoid cross-contamination of raw materials, semi-finished products, and finished products, ensure normal operation of equipment and facilities, require on-site personnel to take hygiene protection measures, and prohibit the use of recycled food, etc.

　　Article 10 Enterprises shall establish a system for factory inspection records.

　　(1) Enterprises shall establish and keep original inspection data and inspection report records of factory foods, including records of food name, specification, quantity, production date, production batch number, implementation standards, inspection conclusions, inspectors, inspection certificate number or inspection report number, inspection time, etc.;

　　(2) Inspectors of enterprises shall have corresponding capabilities;

　　(3) If enterprises entrust other inspection agencies to conduct product factory inspections, they shall check the qualifications of the entrusted inspection agencies and sign entrustment inspection contracts;

　　(4) Factory inspection items shall be consistent with food safety standards and relevant regulations;

　　(5) Enterprises shall have necessary inspection equipment, measuring instruments shall be inspected and qualified or calibrated according to law, and related auxiliary equipment and chemical reagents shall be intact, complete, and within the valid usage period;

　　(6) Enterprises conducting product factory inspections themselves shall perform laboratory measurement comparisons as required and establish and keep comparison records;

　　(7) Enterprises shall keep retained samples of factory inspections according to regulations. For products with a shelf life of less than 2 years, the retention period shall not be less than the product's shelf life; for products with a shelf life of more than 2 years, the retention period shall not be less than 2 years.

　　Article 11 Enterprises shall establish a nonconforming product management system.

　　(1) Enterprises shall establish and keep records of handling purchased nonconforming food raw materials, food additives, and food-related products;

　　(2) Enterprises shall establish and keep records of the handling of non-conforming products.

　　Article 12 The labeling content of food produced and processed by enterprises shall comply with the provisions of laws, regulations, rules, and food safety standards.

　　Article 13 Enterprises shall establish sales ledgers. Enterprises shall establish and keep sales ledgers for each batch of products sold, including product name, quantity, production date, production batch number, purchaser's name and contact information, sales date, shipment date, location, inspection certificate number, delivery control, carrier, and other content.

　　Article 14 The implementation of enterprise standards shall comply with relevant laws and regulations.

　　(1) Enterprise standards shall be filed according to regulations;

　　(2) Enterprises shall collect and record newly issued national food safety standards, participate in relevant training, and ensure the implementation of standards.

　　Article 15 Enterprises shall establish a recall system for unsafe food. Enterprises shall establish and keep records of the execution of voluntary recalls and ordered recalls of unsafe food, including: enterprise notification of recall; actual recall situation; records of remedial, harmless treatment or destruction of recalled products; implementation of corrective measures; reporting recall and handling situations to local government and regulatory departments at or above the county level.

　　Article 16 The health and training of enterprise employees shall comply with relevant laws and regulations.

　　(1) Enterprises shall establish employee health examination and health record systems, and keep relevant records of health management for personnel directly in contact with food;

　　(2) Enterprises shall establish and keep records of food quality and safety knowledge training for employees.

　　Article 17 Enterprises accepting entrusted food processing shall comply with relevant laws and regulations.

　　(1) The entrusted enterprise shall agree on an entrusted processing agreement with the entrusting party within the scope of product varieties for which production permits have been obtained, and report to the local quality and technical supervision department;

　　(2) The packaging and labeling of entrusted processed food shall comply with relevant regulations.

　　Article 18 Enterprises shall establish a consumer complaint acceptance system. Enterprises shall establish and keep records of consumer complaint acceptance, including complainant's name, contact information, name of the food complained about, quantity, production date or batch number, quality issues complained about, measures taken by the enterprise, and handling results.

　　Article 19 Enterprises shall proactively collect food safety risk monitoring and assessment information related to the enterprise found internally and released by the state, respond accordingly, and establish and keep relevant records.

　　Article 20 Enterprises shall properly handle food safety incidents according to regulations.

　　(1) Enterprises shall formulate food safety incident handling plans;

　　(2) Enterprises shall regularly inspect the implementation of various food safety prevention measures;

　　(3) In the event of a food safety incident, enterprises shall establish and keep records of the handling of the incident.

　　Chapter 3 Supervision and Inspection Procedures

　　Article 21 Local quality and technical supervision departments at or above the county level shall prepare annual supervision and inspection plans for enterprises within their jurisdiction based on the food safety annual supervision and management plan organized and formulated by the local people's government, and report for filing according to relevant provincial quality and technical supervision department regulations.

　　Local quality and technical supervision departments at or above the county level may adjust the annual supervision and inspection plan based on the work deployment of higher-level quality and technical supervision departments, food safety risk monitoring information they have, enterprise food safety credit status, regulatory work needs, and other situations.

　　Article 22 Supervision and inspection of enterprises' implementation of quality and safety main responsibilities are divided into special supervision and inspection and routine supervision and inspection.

　　If an enterprise has a quality and safety incident or is suspected of having quality and safety issues, the quality and technical supervision department may carry out special supervision and inspection and directly go to the enterprise to implement supervision and inspection with Attachment 1 "Notice of Supervision and Inspection on the Implementation of Quality and Safety Main Responsibilities by Food Production and Processing Enterprises."

　　For routine supervision and inspection, the quality and technical supervision department shall deliver Attachment 1 "Notice of Supervision and Inspection on the Implementation of Quality and Safety Main Responsibilities by Food Production and Processing Enterprises" to the enterprise 15 working days before the supervision and inspection, informing the enterprise of the relevant items of the supervision and inspection. The notice can be delivered directly or by mail. For direct delivery, the delivery date is the date signed on the receipt by the supervised unit; for mail delivery, the delivery date is the date of receipt.

　　Article 23 After receiving the "Notice of Supervision and Inspection on the Implementation of Quality and Safety Main Responsibilities by Food Production and Processing Enterprises," the inspected enterprise shall conduct self-inspection according to the content of Chapter 2 of these regulations and submit a written self-inspection report to the quality and technical supervision department conducting the supervision and inspection.

　　The self-inspection report shall include the content specified in Attachment 2 "Self-Inspection Form on the Implementation of Quality and Safety Main Responsibilities by Food Production and Processing Enterprises" and other matters that need to be explained.

　　Article 24 After receiving the enterprise's self-inspection report, the quality and technical supervision department shall verify it at the department's workplace. If necessary, the department shall require the inspected enterprise to provide explanations and supplementary report materials.

　　Enterprises shall be responsible for the authenticity of the reports and related materials they submit.

　　Article 25 After verifying the enterprise's self-inspection report and supplementary materials, if the quality and technical supervision department deems it necessary to conduct on-site inspection, it shall inform the enterprise.

　　Article 26 The quality and technical supervision department shall have at least two staff members participate in on-site supervision and inspection of enterprises. When supervision and inspection personnel arrive at the enterprise site, they shall present valid identification. According to supervision and inspection needs, county-level quality and technical supervision departments may invite technical experts, consumer representatives, people's congress representatives, CPPCC members, media reporters, and others to participate in the inspection work.

　　Article 27 The quality and technical supervision department may conduct sampling inspection according to supervision and inspection work needs and relevant regulations.

　　Article 28 The inspected enterprise shall designate relevant personnel to cooperate with the quality and technical supervision department's supervision and inspection work, truthfully provide relevant materials, answer related inquiries, assist in verifying production conditions, and assist in sampling.

　　Enterprises shall actively cooperate with the quality and technical supervision department's supervision and inspection work and shall not obstruct by violence, threats, or other means.

　　Article 29 Supervision and inspection personnel shall truthfully record the supervision and inspection results according to the matters specified in Attachment 3 "Verification Form on the Implementation of Quality and Safety Main Responsibilities by Food Production and Processing Enterprises." Inspectors shall exchange opinions with the participating personnel of the inspected unit on the inspection situation. The supervision and inspection conclusion shall be signed by the supervision and inspection personnel and the legal representative of the inspected enterprise or their authorized person. If the inspected unit has objections to the inspection results, they may sign the objections. Supervision and inspection personnel shall report the supervision and inspection conclusion to their unit.

　　If the inspected unit refuses to sign, the supervision and inspection personnel shall record it in writing and archive it.

　　Article 30 If support or cooperation from the local people's government or relevant departments is needed for supervision and inspection work, the quality and technical supervision department shall propose work suggestions and report in writing to the local people's government or notify relevant departments.

　　Chapter 4 Handling of Supervision and Inspection Results

　　Article 31: Local quality and technical supervision departments at or above the county level shall handle enterprises violating relevant laws and regulations in accordance with the provisions of the relevant laws and regulations when discovered during supervision and inspection.

　　Article 32: The results of supervision and inspection shall be disclosed to the public in accordance with the law.

　　Article 33: Local quality and technical supervision departments at or above the county level shall record the supervision and inspection situation in the enterprise's credit file. Food safety information obtained during supervision and inspection that must be reported to relevant regulatory departments at the same level according to laws and regulations shall be reported accordingly; food safety information directly related to food certification, metrology, and other situations shall be reported to the relevant internal working institutions of the quality and technical supervision department.

　　Chapter 5 Requirements for Supervision and Inspection Work

　　Article 34: Staff participating in enterprise supervision and inspection shall abide by national laws, regulations, and these provisions, conduct strict inspections, enforce the law impartially, and not show favoritism.

　　Article 35: Supervision and inspection personnel shall comply with the enterprise's safety and hygiene protection measures and other system requirements when entering clean areas for on-site inspection.

　　Article 36: During supervision and inspection, normal production activities of enterprises shall not be obstructed; no property shall be solicited or accepted from the inspected enterprises; no other benefits shall be sought.

　　Article 37: Quality and technical supervision departments at all levels shall provide legal, regulatory, and professional technical training to supervision and inspection personnel according to enterprise regulatory business needs, continuously improve their professional level, and include participation in job training as part of the annual assessment of staff.

　　Article 38: Higher-level quality and technical supervision departments may supervise the supervision and inspection work of lower-level departments by reviewing supervision and inspection records, cross-checking, and randomly sampling enterprises.

　　Article 39: Those who engage in any of the following behaviors shall be dealt with according to the cadre management authority and relevant laws and regulations; if a crime is constituted, criminal responsibility shall be pursued according to law:

　　(1) Failure to organize supervision and inspection as required, causing consequences;

　　(2) Concealing supervision and inspection information;

　　(3) Obstructing or interfering with supervision and inspection work;

　　(4) Forging or instructing others to forge records during supervision and inspection;

　　(5) Unauthorized disclosure of enterprise trade secrets;

　　(6) Using supervision and inspection work to participate in paid activities.

　　Article 40: Those who fail to perform the statutory duties of food safety supervision and management in accordance with relevant laws, regulations, and these provisions, neglect daily supervision and inspection, abuse power, derelict duty, or engage in favoritism and fraud shall be given major demerits or demotion according to Article 95 of the Food Safety Law of the People's Republic of China and Article 61 of the Implementing Regulations of the Food Safety Law of the People's Republic of China; those causing serious consequences shall be dismissed or expelled; the main responsible person shall resign in remorse.

　　Article 41: Units and individuals who perform food quality and safety supervision and inspection duties in accordance with these provisions and make outstanding achievements in ensuring food quality and safety shall be commended and rewarded by the higher-level quality and technical supervision departments.

　　Chapter 6 Supplementary Provisions

　　Article 42: Provincial quality and technical supervision departments may formulate implementation rules in accordance with these provisions.

　　Article 43: Quality and technical supervision departments at all levels may refer to these provisions when supervising and inspecting enterprises producing and processing food additives and food-related products.

　　Article 44: These provisions shall be interpreted by the State Administration for Quality Supervision, Inspection and Quarantine.

　　Article 45: These provisions shall come into effect on March 1, 2010.