Special Provisions of the State Council on Strengthening the Safety Supervision and Administration of Food and Other Products

Order of the State Council [2007] No. 503

July 26, 2007

Adopted at the 186th executive meeting of the State Council on July 25, 2007, the Special Provisions of the State Council on Strengthening the Safety Supervision and Administration of Food and Other Products are hereby issued and shall be effective as of the date of issuance.

Premier: Wen Jiabao

Appendix: Special Provisions of the State Council on Strengthening the Safety Supervision and Administration of Food and Other Products

Article 1 These Provisions are formulated in order to strengthen the supervision and administration of the safety of food and other products, further define the responsibilities of the producers and operators, the supervision and administration authorities and local people's government, strengthen the coordination and cooperation among the supervision and administration authorities ("regulatory authorities"), and protect human health and life safety.

Article 2 The products as mentioned in these Provisions shall, in addition to food, include edible agricultural products, drugs and other products related to human health and life safety.
Where a law provides for the supervision and administration of a product, such a law shall apply; where a law does not provide or provides unclearly for the supervision and administration of a product, these Provisions shall apply.

Article 3 A producer or business operator shall be responsible for the safety of products produced or sold by it, and shall not produce or sell products that do not conform to the statutory requirements.
Where the production or sale of products requires a license or authentication according to a law or administrative regulation, the production or business operation shall be carried out in conformity with the statutory conditions and requirements. Where the production or business operation is not carried out in conformity with the statutory conditions and requirements or the products that do not conform to the statutory requirements are produced or sold, the regulatory authorities for agriculture, health, quality inspection, commerce, industry and commerce, drug, etc., in their respective capacities, shall confiscate the illegal income, products and tools, equipment, raw materials and other property used for the illegal production, and impose a fine of CNY50,000 if the value of goods is less than CNY5,000, impose a fine of CNY100,000 if the value of goods is more than CNY5,000 but less than CNY10,000, or impose a fine of not less than 10 times but not more than 20 times the value of goods if the value of goods is more than CNY10,000; if serious consequences are caused, the original license issuing authority shall cancel a license; and if a crime of illegal business operation, production or sale of fake or substandard commodities, etc. is constituted, the offender shall be pursued for criminal liability according to law.
Where a producer or business operator is no longer in conformity with the statutory conditions and requirements but continues the production or business operation, the original license issuing authority shall cancel a license, and announce the list of producers and operators whose licenses have been cancelled on the major local media; and if a crime of illegal business operation, production or sale of fake or substandard commodities, etc., is constituted, the offender shall be pursued for criminal liability according to law.
Where a license for the production or business operation shall be legally obtained but is not obtained, the regulatory authorities for agriculture, health, quality inspection, commerce, industry and commerce, drug, etc., in their respective capacities, shall confiscate the illegal income, products and tools, equipment, raw materials and other property used for the illegal production, and impose a fine of CNY100,000 if the value of goods is less than CNY10,000 or impose a fine of not less than 10 times but not more than 20 times the value of goods if the value of goods is more than CNY10,000; and if a crime of illegal business operation is constituted, the offender shall be pursued for criminal liability according to law.
The relevant industrial associations shall strengthen the self-regulation in their respective industries, supervise the productions and business operations of the producers and business operators; strengthen the dissemination and publicity of public health knowledge, and guide the consumers to choose products produced and sold by legitimate producers and business operators and products with legitimate labels.


Article 4 The raw materials, accessories, additives and agricultural inputs used by a producer for producing the products shall comply with the provisions of laws and administrative regulations and mandatory standards of the state.
Where the raw materials, accessories, additives or agricultural inputs are illegally used, in violation of the preceding paragraph, the regulatory authorities for agriculture, health, quality inspection, commerce, drug, etc., in their respective capacities, shall confiscate the illegal income, and impose a fine of CNY20,000 if the value of goods is less than CNY5,000, impose a fine of CNY50,000 if the value of goods is more than CNY5,000 but less than CNY10,000, or impose a fine of not less than 5 times but not more than 10 times the value of goods if the value of goods is more than CNY10,000; if serious consequences are caused, the original license issuing authority shall cancel a license; and if a crime of production or sale of fake or substandard commodities is constituted, the offender shall be pursued for criminal liability according to law.

Article 5 A seller must establish and implement a product supply inspection and acceptance system, examine the business qualifications of suppliers, verify the certificates of qualified products and product labels, and establish a product supply account to truly record the names, specifications, quantities, suppliers and their contacts, time of supply, etc. of products. A sales enterprise engaging in the product wholesale business shall establish a product sales account to truly record the types, specifications, quantities, flow, etc. of the wholesale products. A production enterprise selling self-made products at a centralized trading place of products shall perform its duty of establishing a product sales account by analogy in line with the provisions on a sales enterprise engaging in the product wholesale business. The product supply account and sale account shall be kept for at least two years. By the production lot of products, a seller shall ask for an inspection report issued by an inspection agency in conformity with the statutory conditions or a photocopy of an inspection report signed or sealed by the suppler from the supplier; and where such an inspection report or a photocopy of an inspection report cannot be provided, the products shall not be sold.
For any violation of the preceding provision, the regulatory authorities for industry and commerce and drug, in their respective capacities, shall order cessation of production; where an inspection report or a photocopy of an inspection report cannot be provided and products are sold, shall confiscate the illegal income and illegally sold products, and impose a fine of three times the value of goods; and if serious consequences are caused, the original license issuing authority shall cancel a license.

Article 6 An enterprise launching a centralized trading market of products, an enterprise leasing out counters for marketing products, or an enterprise sponsoring or holding a product exhibition fair shall examine the business qualifications of an admitted seller, clarify an admitted seller's responsibly for product safety, regularly inspect an admitted seller's business environment, conditions and internal safety administration system and products' conformity with statutory requirements, and when finding any sales of products not in conformity with the statutory requirements or finding any other violation, timely stop the same and immediately report on it to the administrative authority for industry and commerce at the place where it is located.
For any violation of the preceding provision, the administrative authorities for industry and commerce shall impose a fine of not less than CNY1,000 but not more than CNY50,000; if the circumstances are serious, shall order cessation of production for correction; and if serious consequences are caused, the business license shall be cancelled.

Article 7 A producer or business operator of export products shall ensure their export products to conform to the standards of import country (or region) or the contractual requirements. Where a law provides that the products must undergo inspection before export, the products shall pass the inspection conducted by an agency meeting the legal provisions.
Export product inspectors shall conduct inspection according to laws and administrative regulations and relevant standards, procedures and methods, and shall be responsible for the inspection certificates produced by them.
The entry-exit inspection and quarantine agencies and regulatory authorities for commerce, drug, etc. shall establish and make available to the public the good and bad records of producers and business operators of export products. For those with good records, the formalities for inspection and quarantine shall be simplified.
Where a producer or business operator of export products evades the product inspection or makes falsehood, the entry-exit inspection and quarantine agency and drug regulatory authority, in their respective capacities, shall confiscate the illegal income and products, and impose a fine of three times the value of goods; and if a crime is constituted, the offender shall be pursued for criminal liability according to law.


Article 8 Import products shall conform to the mandatory requirements of the state technical specifications of this country and the inspection requirements as provided for by an agreement signed between China and the export country (or region).
The regulatory authorities for quality inspection and drug shall implement the categorized administration of import products and the record-filing administration of consignees, as per the degree of credibility and level of quality administration of a producer or business operator and the results of risk assessment of import products. The consignees of import products shall truly record the flow of import products. The period of record keeping shall be at least two years.
When finding any products not in conformity with the statutory requirements, the regulatory authorities for quality inspection and drug may list the importers, inspection declarers and agents of products not in conformity with the statutory requirements on the bad record list. Where an importer or seller of import products makes falsehood, the regulatory authority for quality inspection and drug, in their respective capacities, shall confiscate the illegal income and products, and impose a fine of three times the value of goods; and if a crime is constituted, the offender shall be pursued for criminal liability according to law. Where an inspection declarer or agent of import products makes falsehood, the qualifications for inspection declaration shall be cancelled, and a fine of the value of goods shall be imposed.


Article 9 When finding potential safety risk in products that may cause injury to human health and life safety, enterprises manufacturing such products shall publicize the relevant information to society, notify sellers to stop the sales, notify consumers to cease using the products, withdraw the products actively and report the relevant information to the regulatory authorities concerned. Sellers shall cease to sell the products immediately. When finding potential safety risk in products that may cause injury to human health and life safety, sellers marketing such products shall cease to sell the products immediately, notify manufacturing enterprises or suppliers and report the relevant information to the regulatory authorities concerned.
Where manufacturing enterprises and sellers fail to perform the obligations specified in the preceding paragraph, agriculture, health, quality, commerce, industry and commerce and other regulatory authorities shall, according to their own authorities, order the enterprises to withdraw the products and sellers, cease to sell them. A fine of three times the value of the products shall be imposed on the enterprises and a fine more than CNY1,000 and less than CNY50,000 on the sellers. Where serious consequences are involved, the license shall be revoked by the issuing authority.

Article 10 Local people's governments above the county level shall take product safety supervision and administration as one of the governments' evaluation objectives and take an overall responsibilities for the product safety supervision and administration within their administrative regions. Local governments shall lead and coordinate the supervision and administration work within their administrative regions, establish and improve a coordination mechanism for supervision and administration and strengthen the uniform law enforcement and supervision, make overall arrangements to respond to product quality emergencies, organize the investigation and punishment of product quality safety accident and establish an accountability system to evaluate and examine the work of all regulatory authorities. Quality,industry and commerce administration, drug administration and other regulatory authorities shall, under the coordination of the people's government at the same level, do a good job in the product safety supervision and administration.
Where local people's governments above the county level fail to perform their duties in leading and coordinating the work in quality safety supervision and administration and there occur more than one quality safety accident in the administrative region within one year that have a major impact on society, the main responsible person and the directly responsible personnel in charge shall be subject to demerits, demotion or deposition imposed by the supervision department or department appoint these persons.

Article 11 The competent quality inspection, health, agriculture and other relevant authorities under the State Council shall establish, amend or draft the relevant national standards within their competence in a timely manner and accelerate the establishment of a scientific and reasonable product standards system which is under uniform administration, is supported by relevant systems, and meets the actual requirements.

Article 12 The people's government above the county level and the departments thereof shall observe the statutory authority and procedures when performing their functions and duties in supervision and administration of product safety and follow the principles of openness, equality and justice. The same violation of law committed by a manufacturer or operator may not be subject to two or more than two administrative punishments in the form of a fine. In the event that a crime and criminal liabilities are involved, the case shall be forwarded to the public security organ in accordance with the Provisions on Transfer of Suspected Criminal Cases by the Administrative Law-Enforcement Organs.
The regulatory authorities of agriculture, health, quality inspection, commerce and medicine, etc shall supervise and inspect manufacturers and operators according to their respective functions and duties and keep a record of their performance in compliance with compulsory standards and statutory requirements, which shall be put on file after being signed by personnel in charge of supervision and inspection. Records of supervision and inspection shall part of evaluation content for the directly responsible persons in charge and the general public shall have the right to consult these records.

Article 13 Where manufacturers or operators are involved in any of the following circumstances, regulatory authorities of agriculture, health, quality inspection, commerce and medicine, etc shall take measures according to their respective duties to make corrections of violations and to prevent or reduce damage and shall impose punishment in accordance with these Provisions:
1. They engage in manufacture and operation without a business license that shall be obtained in accordance with the law;
2. They engage in manufacture and operation in violation of statutory conditions and requirements or manufacture and sell products that fail to meet the statutory requirements after obtaining a business license or being authenticated;
3. They continue to engage in manufacture and operation after they do not meet the statutory conditions or requirements any longer;
4. They fail to abide by the relevant provisions of laws and regulations or the compulsory national standards when using raw materials, auxiliary materials, addictives and agricultural input products;
5. Sellers fail to establish and implement the system of goods inspection or to establish a delivery account;
6. Manufacturing enterprises and sellers fail to perform the duties specified in these Provisions after finding out potential safety risk in the products they produce or sell that may cause damage to human health and life safety;
7. Violations of other relevant provisions in laws, administrative regulations and these Provisions.
Where regulatory authorities of agriculture, health, quality inspection, commerce and medicine, etc fail to perform the aforesaid duties specified in the preceding paragraph and causes consequences, the main responsible person, the directly responsible personnel in charge and other directly responsible persons shall be subject to demerits or demotion imposed by the supervision department or department appoint these persons. Where serious consequences are involved, deposition or dismissal shall be imposed on the the main responsible person, the directly responsible personnel in charge and other directly responsible persons. Any main responsible person, the directly responsible personnel in charge and other directly responsible persons who are involved in a crime of malpractice shall be investigated into criminal liabilities.
In the case of abuse of power or other malpractice, the main responsible person, the directly responsible personnel in charge and other directly responsible persons shall be subject to demerits or serious demerits imposed by imposed by the supervision department or department appoint these persons. Where serious consequences are involved, deposition or dismissal shall be imposed on the the main responsible person, the directly responsible personnel in charge and other directly responsible persons. Any main responsible person, the directly responsible personnel in charge and other directly responsible persons who are involved in a crime of malpractice shall be investigated into criminal liabilities.

Article 14 Where regulatory authorities of agriculture, health, quality inspection, commerce and medicine, etc find that any violation of these Provisions shall be dealt with by other regulatory authorities, they shall immediately notify and transfer the case to the competent authorities which shall not deal with the case right now and may not make an excuse to refuse or delay the case. Where any consequence occurs due to delay, the main responsible person and the directly responsible personnel in charge shall be subject to demerits, demotion or deposition imposed by the supervision department or department appoint these persons.

Article 15 The regulatory authorities of agriculture, health, quality inspection, commerce and medicine, etc shall perform their supervisory and administrative duties on product safety and have the following powers:
1. Entering manufacturing and operating sites and making on-spot inspections;
2. Consulting, copying, seizing and sequestrating contracts, invoices, account books and other materials concerned;
3. Seizing and sequestrating products failing to comply with law and illegally-used raw materials, auxiliary materials, additives, agriculture input products and tools and equipment used in illegal production;
4. Seizing manufacturing and operating sites that have potential risks damaging human health and life safety.

Article 16 The regulatory authorities of agriculture, health, quality inspection, commerce and medicine, etc shall establish a system recording and disclosing violations committed by manufacturers and operators. The business license of any manufacturer or operator that violates the law for many times shall be revoked.

Article 17 Where the false inspection report issued by an inspection and testing institution causes a serious consequence, the department approves its qualification shall revoke its qualification for inspection and testing. Where it involves a crime, the directly responsible person in charge and other directly responsible persons shall bear criminal liabilities.

Article 18 When there occurs a product safety accident or other product safety incidents that have a major social impact, regulatory authorities of agriculture, health, quality inspection, commerce and medicine, etc shall make immediate response within their duties and take measures to control the development of the situation and reduce loss. These authorities shall publicize relevant information in accordance with the regulations of the State Council and properly deal with the follow-up work.

Article 19 Any organization or individual shall have the right to report activities in violation of these Provisions and the department receiving such reports shall keep the status of the reporter confidential. Where the violation is proved truthful through investigation, a department accepting the report shall award the reporter.
The regulatory authorities of agriculture, health, quality inspection, commerce and medicine, etc shall disclose their email or telephone numbers and record and properly keep any report in a timely and complete manner. Where issues reported fall within the functions and duties of the department, the authority shall accept the report and verify, handle and respond to the report. Where issues reported are not within the functions and duties of the department, the authority shall forward the issues to the compete authorities and inform the reporter.

Article 20 These Provisions shall come into effect as of the date of promulgation.