Promulgation Authorities:  State Council

Promulgation Date:  2007.07.26

Effective Date:  2007.07.26

Validity Status:  valid

Document Number:  Decree of the State Council No.503

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

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

Decree of the State Council No.503

The Special Rules of the State Council on Strengthening Supervision and Administration of the Safety of Food and Other Products, adopted at the 186th executive meeting of the State Council on 25 July 2007, are hereby promulgated, effective on the date of promulgation.

Premier Wen Jiabao

26 July 2007

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

Article 1    These Rules are formulated in order to strengthen the supervision and management of the safety of food and other products, further regulate the responsibilities of producers, business operators, regulatory authorities and local people's governments, enhance the coordination and cooperation among various regulatory authorities, and safeguard human health and life safety.

Article 2    For the purpose of these Rules, products include food, edible agricultural products, drugs and other products relating to human health and life safety.

Where there are regulations for supervision and administration of product safety, such regulations shall apply. These Rules will apply in the absence of appropriate or explicit regulations.

Article 3    Producers and business operators shall be responsible for the safety of products produced or sold by them, and shall not produce any product not satisfying statutory requirements.

Where a permit or certificate is required by laws or administration regulations for producing or selling products, such production or operation activities shall be carried out under statutory conditions and requirements. With regard to production or operation activities not carried out under statutory conditions or requirements or producing or selling products not satisfying statutory requirements, the regulatory authorities in charge of agriculture, health, quality control, business affairs, industry & commerce and drug, etc. will, according to the division of duties, confiscate illegal gains, products and tools, equipment, raw materials and other articles used for production in violation of laws, and concurrently impose a fine of 50,000 yuan if the value of goods is less than 5,000 yuan; the fine will be 100,000 yuan if the value of goods is less than 10,000 yuan but more than 5,000 yuan; and if the value of goods is more than 10,000 yuan, the fine will be 10 to 20 times thereof; in case of a serious consequence, the permit will be revoked by the authorities issuing the permit; and criminal liability will be pursued according to law if the crime of illegal business operation or the crime of producing or selling shoddy commodities is constituted.

If producers or business operators continue engaging in production or operation activities when they no longer satisfy statutory conditions or requirements, their permits will be revoked by the authorities issuing the permits, and the list of such producers or business operator will be announced on local main media; criminal liability will be pursued according to law if the crime of illegal business operation or the crime of producing or selling shoddy commodities is constituted.

With regard to production or operation activities carried out without a permit that is required by law, the regulatory authorities in charge of agriculture, health, quality control, business affairs, industry & commerce and drug, etc. will, according to the division of duties, confiscate illegal gains, products and tools, equipment, raw materials and other articles used for production in violation of laws, and concurrently impose a fine of 50,000 yuan if the value of goods is less than 5,000 yuan; the fine will be 100,000 yuan if the value of goods is less than 10,000 yuan but more than 5,000 yuan; and if the value of goods is more than 10,000 yuan, the fine will be 10 to 20 times thereof; in case of a serious consequence, the permit will be revoked by the authorities issuing the permit; and criminal liability will be pursued according to law if the crime of illegal business operation or the crime of producing or selling shoddy commodities is constituted.

The trade associations concerned shall enhance industry self-regulation, supervise production or operation activities of producers or business operators, strengthen the popularization and publicity of health knowledge among the public, guide consumers to choose products produced or sold by lawful producers or business operators and products with legal mark.

Article 4    Raw materials, auxiliary materials, additives, agricultural inputs to be used by producers for production shall comply with the provisions of laws or administrative regulations and satisfy the national mandatory standards.

With regard to any use of raw materials, auxiliary materials, additives, agricultural inputs in violation of law specified in the preceding paragraph, the regulatory authorities in charge of agriculture, health, quality control, business affairs, industry & commerce and drug, etc. will, according to the division of duties, confiscate illegal gains, and concurrently impose a fine of 20,000 yuan if the value of goods is less than 5,000 yuan; the fine will be 50,000 yuan if the value of goods is less than 10,000 yuan but more than 5,000 yuan; and if the value of goods is more than 10,000 yuan, the fine will be 5 to 10 times thereof; in case of a serious consequence, the permit will be revoked by the authorities issuing the permit; and criminal liability will be pursued according to law if the crime of producing or selling shoddy commodities is constituted.

Article 5    Sellers must establish and implement inspection and acceptance system for purchases, check suppliers' business qualification, verify products' quality certificate and product identification, and establish a ledger to truthfully record the name, specification and quantity, and suppliers of purchased products as well as contact information and purchase time, etc. Sales companies engaging in wholesale business shall establish a ledger to truthfully record the variety, specification, quantity and flow direction of wholesales. Production enterprises that sell self-produced products in centralized trading venues shall fulfill their obligation to establish a ledger of product sales with reference to the rules for sales companies engaged in wholesale business. The ledger of purchased or sold products shall be kept for at least two years. Sellers shall ask for the test report issued by an inspection body satisfying legal conditions or the photocopy of the test report signed or sealed by the supplier for the batch of products from suppliers; no product sale is allowed in the absence of a test report or photocopy of the test report.

With regard to activities in violation of the provisions specified in the preceding paragraph, the regulatory authorities in charge of industry & commerce and drug shall, according to division of duty, order to cease sales; For sales of products without a test report or photocopy of a test report, the illegal gains and products illegally sold will be confiscated, and a fine of three times the value of goods imposed; in case of a serious consequence, the permit will be revoked by the authorities issuing the permit.

Article 6    Business operators of centralized product trading markets, enterprises leasing product management counters and enterprises holding product exhibitions shall examine the business qualification of the accessed sellers, specify the product safety management responsibility of such sellers, and inspect on a regular basis that whether the business environment, conditions, internal safety management system and product traded satisfy statutory requirements, and promptly hold down any sales of product not satisfying statutory requirement or other illegal activity and forthwith report the case to the local regulatory authorities in charge of industry & commerce.

Any activity in violation of the provisions specified in the preceding paragraph will be imposed a fine of less than 50,000yuan but more than 1,000 yuan by the regulatory authorities in charge of industry & commerce; in serious cases, regulatory authorities in charge of industry & commerce will order to cease the business for rectification and revoke business license in case of serious consequence.

Article 7    The producers or business operators of products to be exported shall ensure that the products exported by them satisfy the standards of the import country (region) or contract requirements. If the products, as required by laws, must be inspected prior to export, they shall pass the inspection conducted by a qualified body according to law.

Export product inspection personnel shall, in accordance with laws or administrative regulations and under relevant standards, procedures and method, conduct inspection, and be responsible for the inspection certificate issued by them.

Entry-exit inspection and quarantine bodies and regulatory authorities in charge of business affairs, drug, etc. shall establish a list of producers and business operators of exports and a blacklist thereof, and make public the lists. For producers and business operators of exports with good faith, the formalities of inspection and quarantine shall be simplified.

With regard to the producers and business operators of exports who evade product inspection or practice fraud, the Entry-exit inspection and quarantine bodies and drug regulatory authorities will, according to division of duties, confiscate illegal gains and products, and concurrently impose a fine of three times the value of goods; criminal liability shall be pursued according to law if a crime is constituted.

Article 8    Imported products shall satisfy the mandatory requirements specified in China's national technical specifications as well as the inspection requirements provided in the agreement entered into between and by China and the export country (region).

Regulatory authorities in charge of quality control and drug shall, based on producers and business operators' creditability and quality management level as well as the risk assessment result of imported products, manage imported products by category and manage consignees of imported products by record-filing. Consignees of imported products shall truthfully record the flow of imported products. Such record shall be kept for at least two years.

When finding out products not satisfying statutory requirements, the regulatory authorities in charge of quality control and drug shall record the purchaser, inspection declarer and agent of such product into the blacklist. With regard to fraud committed by purchasers or sellers of imported products, the regulatory authorities in charge of quality control and drug shall, according to the division of duties, confiscate illegal gains and products, and concurrently impose a fine of three times the value of goods; the criminal liability shall be pursued if a crime is constituted. For the inspection declarers and agents of imported products who practice fraud, their inspection declaration qualification will be cancelled and concurrently imposed a fine of equivalent to the value of goods.

Article 9    Where a production enterprise discovers that the products it produced have potential safety risk, which might cause harm to human health and life safety, it shall make public the relevant information, inform sellers and consumers to stop selling or using the products, take initiative to recall the products, and report the case to the regulatory authorities concerned; the sellers shall forthwith stop selling such products. While sellers who discover the products it sells have potential safety risk, which might cause harm to human health and life safety shall forthwith stop sell such products, inform the producer or supplier thereof, and report the case to the regulatory authorities concerned.

With regard to the producers and sellers who do not perform the obligations provided in the preceding paragraph, the regulatory authorities in charge of agriculture, health, quality control, business affairs, industry & commerce and drug, etc. will, according to the division of duties, order the producers and sellers to recall or stop selling the products, and concurrently impose a fine of three times the value of goods against the producers and a fine of less than 50,000 yuan but more than 1,000 against the sellers; in case of a serious consequence, the permit will be revoked by the authorities issuing the permit.

Article 10    The people's governments above county level shall include product safety management into their government performance appraisal goal, be responsible in general for the supervision and administration of  product safety within their respective administrative regions, lead and coordinate in a unified manner the supervision and administration  within their respective administrative regions, establish and improve a coordination mechanism for supervision and administration, strengthen the coordination and supervision over administrative enforcement of law, lead and command in a unified manner the work to cope with product safety emergencies, investigate product safety accident according to law, appraise and assess various regulatory authorities. The regulatory authorities in charge of quality control, industry & commerce, drug, etc. shall, under the unified coordination of the local people's government at the same level, properly supervise and administer product safety according to law.

With regard to a local people's government above county level that does not perform its duty of leading and coordinating supervision and administration of product safety, resulting in one or more product safety accidents within one year within its administrative jurisdiction and causing serious social impact, the supervising authorities or authorities in charge of official appointment and dismissal will punish the person chiefly in charge   in charge of the government and the directly liable person by recording a serious demerit, demotion or removal from office.

Article 11    The State Council's departments in charge of quality control, health, agriculture, etc. shall, within the scope of their respective duties, develop, amend or draft relevant national standards as early as possible, accelerate the establishment of a product standard system for unified administration, coordination and supporting which is in light of actual conditions and scientific and reasonable.

Article 12    The people's governments above county level shall perform their duties of supervision and administration of product safety within their statutory limit of authority and under procedures in an open, fair and impartial manner. For the same illegal act committed by a producer or business operator, it is not allow to impose twice or more times administrative punishment of fine; Any case suspected of constituting a crime and subject to criminal liability according to law shall be referred to the public security authorities in accordance with the Rules on Referring Criminal Cases by Administrative Authorities for Law Enforcement.

The regulatory authorities in charge of agriculture, health, quality control, business affairs, industry & commerce and drug, etc. shall, according to the division of duties, supervise and inspect producers and business operators, and record the information about their compliance with mandatory standards and statutory requirements, which is to be filed after being signed by the supervision and inspection personnel. The supervision and inspection record shall be included into the regulator assessment of performance of the persons directly in charge. The public may access the supervision and inspection record.

Article 13    Under any of the following circumstances, the regulatory authorities in charge of agriculture, health, quality control, business affairs, industry & commerce and drug, etc. shall, according to the division of duties, take measures to correct illegal acts, prevent or reduce harm, impose punishments according to these Rules:

(1) Carrying out production or operation activities without a permit which is required according to law;

(2) After obtaining a permit or certificate, failure to carrying out production or operation activities under statutory conditions or requirements or producing or selling products not satisfying statutory requirements;

(3) The producers or business operators no longer satisfy statutory conditions or requirements but continue carrying out production or operation activities;

(4) The producers or business operators violate laws or administrative regulations and national mandatory standards in using raw materials, auxiliary materials, additives, agricultural inputs;

(5) The sellers neither establish and implement a system for inspection and acceptance of purchased goods, nor establish a ledger of purchased goods.

(6) The producers or business operators discover the products they produced or sold have potential safety risk, which might harm human health and life safety, but do not perform the obligations specified in these Rules; and

(7) The producers and business operators violate other relevant provisions of laws, administrative regulations or these Rules.

With regard to the regulatory authorities in charge of agriculture, health, quality control, business affairs, industry & commerce and drug, etc.that do not perform the duties specified in the preceding paragraph, resulting in a consequence, the supervising authorities or the authorities in charge of official appointment or dismissal shall punish the person chiefly in charge  , the person directly in charge and other directly liable persons by recording a serious demerit or giving a demotion; for a serous consequence, the person chiefly in charge  , the person directly in charge and other directly liable persons shall be punished by removal from office or dismissal; if the person chiefly in charge  , the person directly in charge and other directly liable persons constitute the crime of misconduct in office, the criminal liability shall be pursued according to law.

With regard to the misuse of authority or other misconduct in office, which is in violation of these Rules, the supervising authorities or the authorities in charge of official appointment or dismissal shall punish the person chiefly in charge, the person directly in charge and other directly liable persons by recording a demerit or a serious demerit; for a serous consequence, the person chiefly in charge, the person directly in charge and other directly liable persons shall be punished by demotion or removal from office; if the person chiefly in charge, the person directly in charge and other directly liable persons constitute the crime of misconduct in office, the criminal liability shall be pursued according to law.

Article 14    Where the regulatory authorities in charge of agriculture, health, quality control, business affairs, industry & commerce or drug, etc. discover that an act in violation of these Rules falls is subject to the duty of other regulatory authorities, they shall forthwith notify in writing the refer the case to the competent regulatory authorities. The competent regulatory authorities shall forthwith handle the case without buckpassing. In the case of not forthwith handling the case or buckpassing, resulting in a consequence, the supervising authorities or the authorities in charge of official appointment or dismissal shall punish the person chiefly in charge, the person directly in charge and other directly liable persons by recording a serious demerit or demotion.

Article 15    The regulatory authorities in charge of agriculture, health, quality control, business affairs, industry & commerce or drug, etc. have the following powers in their performing of duties for supervising and administering product safety:

(1) Enter a production or operation site for on-site inspection;

(2) Access, reproduce, seal up or detain relevant contracts, bills, accounting books and other documents concerned;

(3) Seal up or detain any product not satisfying statutory requirements, illegally used raw materials, auxiliary materials, additives, agricultural inputs as well as tools and equipment used for illegal production; and

(4) Seal up a production or operation site that have potential risks to harm human health and life safety.

Article 16    The regulatory authorities in charge of agriculture, health, quality control, business affairs, industry & commerce or drug, etc. shall establish a system to record illegal acts committed by producers or business operators, make public such record, and revoke the permit of the producer or business operator with more than once illegal acts recorded.

Article 17    With regard to an inspection agency which has issued false inspection report, resulting in a serious consequence, the authorities granting it the inspection qualification shall revoke the inspection qualification thereof; in case of a crime constituted, criminal liability shall be pursued against the person directly in charge and other directly liable persons.

Article 18    For a product safety accident or other product safety event that has serious impact among the public, the regulatory authorities in charge of agriculture, health, quality control, business affairs, industry & commerce or drug, etc. must timely make response to it within their respective limit of authority, take measures to control the spread of the case, reduce losses, release information according to provisions of the State Council, and properly deal with the aftermath.

Article 19    Any organization or individual may report acts in violation of these Rules. The authorities receiving the report shall keep confidential the informant. The authorities accepting the report shall reward the informant if the report is verified upon investigation.

The regulatory authorities in charge of agriculture, health, quality control, business affairs, industry & commerce or drug, etc. shall make public their email address or telephone number for informants, record a received report in a timely and complete manner, and properly keep the record. The authorities receiving a report on matters not subject to their duties shall refer the case to the competent authorities, and inform the informant thereof.

Article 20    These Rules come into force on the date of promulgation.