Laws of the People's Republic of China

N0.79

Implementation Rules for the Supervision and Administration on the Quality Safety of the Food Manufacturing and Processing Enterprise (For Trial) was discussed and adopted at the Executive Meeting of the General Administration of Quality Supervision, Inspection and Quarantine on August 31, 2005. It is hereby promulgated and shall enter into force as of the date of September 1, 2005. And the Measures for the Supervision and Administration on the Quality Safety of the Food Manufacturing and Processing Enterprise promulgated by the General Administration of Quality Supervision, Inspection and Quarantine on July 18, 2003 shall be abolished at the same time. Director-General: Li Changjiang

September 1, 2005

Implementation Rules for the Supervision and Administration on the Quality Safety of the Food Manufacturing and Processing Enterprise (For Trial) Chapter I General Provisions

Article 1

These Rules are formulated in accordance with the relevant provisions in Product Quality Law of the People's Republic of China, in Regulations of the People's Republic of China for the Administration of the Manufacturing Permit for Industrial Products, in Decision of the State Council on Further Strengthening the Food Safety Work, and in the function of the General Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as the AQSIQ) endowed by the State Council, for the purposes of strengthening the supervision and administration on the quality safety of the food manufacturing and processing enterprise, of enhancing the food quality safety, and of safeguarding the safety and health of the general public.

Article 2

Anyone who engages in the business of food manufacturing and processing for the purpose of sale within the territory of the People's Republic of China shall abide by these Rules. And the administration of food import/export shall be subject to the laws, administrative regulations and relevant state provisions.

Article 3

"The food" as mentioned in these Rules refers to such edible and drinkable product for sale as undergoes processing and manufacturing.

"The food manufacturing and processing enterprise" as mentioned in these Rules refers to such unit and individual (including the self-employed unit of industry and commerce) as have a fixed workshop (locality) and processing equipments and installations, and as process, manufacture, distribute and package the food for sale in accordance with a certain technological flow.

Article 4

The food shall accord with the quality safety provisions in the national laws, administrative regulations and national standards and the industrial standards, and meet the requirements of safeguarding body health and life safety, and shall not have the unjustifiable risks endangering health and safety, and exceed the limitations on toxic and hazardous materials.

The indicators for food quality safety shall include the physical and chemical indicator, sensory indicator, hygienic indicator and label and mark, which are stipulated in the standards.

Article 5

The state exercises a market access system for food quality safety. The food manufacturing and processing enterprise shall possess the requisite conditions for guaranteeing food quality safety (hereinafter referred to as the "requisite conditions"), and acquire the manufacturing permit for industrial products (hereinafter referred to as the food manufacturing permit); and the manufactured and processed food shall pass the test and be printed (pasted) with the market access symbol for food quality safety before leaving the factory for sale.

An enterprise without a food manufacturing permit, shall not engage in the manufacturing of the food upon which an administration of manufacturing permit has been exerted by the State. And such food as fails to pass the test and be printed (pasted) with the market access symbol for food quality safety shall not leave the factory for sale.

Article 6

The AQSIQ shall be responsible for an overall organization of the supervision and administration of quality safety of the food manufacturing and processing enterprise. The local quality and technology supervision authorities shall, in accordance with the overall arrangement requirement of the AQSIQ, be, within their own scopes of duties, responsible for organizing the carrying-out of the supervision and administration of quality safety of the food manufacturing and processing enterprise.

Article 7

The supervision and administration of quality safety of the food manufacturing and processing enterprise shall be subject to the principle of scientificity and fairness, openness and transparency, procedural legality, and convenience and efficiency.

The organ and its working staff undertaking the supervision and administration of quality safety of the food manufacturing and processing enterprise shall administer by law, hold the pass strictly, serve warmly and practice probity and self-discipline.

The quality and technology supervision authorities above the county level and its working staff, inspection institutions and inspection personnel have the duty of keep secret their acquainted national secrets and commercial secrets.

Article 8

Any unit and individual are entitled to report to the quality and technology supervision authorities at every level the offenses against the provisions in these Rules. The authorities handling the reported offenses shall conduct timely investigations and prosecutions and keep secret the reporters, and the person worthy of merit in reporting offenses shall be rewarded in accordance with relevant provisions.

Chapter II Requisite Conditions for a Food Manufacturing and Processing Enterprise

Article 9

A food manufacturing and processing enterprise shall meet the conditions established in laws, regulations and national industrial policies.

Article 10

A food manufacturing and processing enterprise shall possess and meet continually the environmental conditions and corresponding hygienic requirements for guaranteeing product quality safety.

Article 11

A food manufacturing and processing enterprise shall possess the manufacturing facilities, technical equipments and relevant ancillary devices, possess such workshop (locality) for material treatment, processing, packaging, stockpiling and inspection etc. as accords with product quality safety. The special equipment and locality for food manufacturing and processing shall meet the conditions stipulated in relevant laws, regulations and technological norms.

Article 12

The raw materials and food additives (including auxiliary agents for food processing, the same below) used by a food manufacturing and processing enterprise in its business shall accord with relevant national provisions. And such food raw materials and inedible raw accessories as are overdue, non-serviceable, rotten, filthy, recycled, and polluted in other ways shall not be used against the provisions. And such used raw accessories as are subject to the administration of manufacturing permit shall be purchased from the enterprise with such a permit.

Article 13

A food manufacturing and processing enterprise shall adopt a scientific and reasonable food processing flow, tighten and regulate the manufacturing and processing procedures, prevent the biological, chemical and physical contaminations and the cross contaminations between the food for processing and the directly edible food, and between the raw materials and the semi-finished and finished products, and keep food far from the toxic and hazardous articles or other unhygienic articles.

Article 14

A food manufacturing and processing enterprise shall conduct its business in accordance with the effective product standards. Where the food subject to the administration of market access for food quality safety is manufactured in accordance with the standard of the enterprise itself, the enterprise's standard concerned shall be in line with the requirements of the national standard and industrial standard, and shall bear no lowering of the food quality safety indicators.

Article 15

A food manufacturing and processing enterprise shall possess such specialized technological personnel, skilled workers, quality control personnel and inspection personnel as are adaptive to its business. The personnel engaging in food manufacturing and processing shall possess healthy body, no infectious diseases and no other diseases jeopardizing food quality safety, and a health certificate; and the inspection personnel shall possess the inspection capacity concerning the related products, and acquire the qualification for engaging in food quality inspection. The working staff in the food manufacturing and processing enterprise shall possess related knowledge concerning food quality safety, and its person in charge and the main managerial personnel shall also be acquainted with the knowledge of the laws and regulations concerning food quality safety.

Article 16

A food manufacturing and processing enterprise shall possess means of quality safety inspection and metrological inspection accommodating its products, and the inspection and testing instruments shall pass the metrological verification and meet the requirements after calibration, and shall be used within the term of validity. And the enterprise concerned shall possess the capacity for ex-factory inspection, which shall be carried out in accordance with the provisions.

Article 17

A food manufacturing and processing enterprise shall construct and improve a quality control system of the enterprise itself, and carry out a standardized management during the whole manufacturing process, and an overall quality control management containing raw materials purchase, control and inspection in manufacturing, product ex-factory inspection and post-sale service.

The food manufacturing and processing enterprise is encouraged to acquire, in accordance with the universal quality control standards and technological norms, the quality system certification or the Hazard Analysis and Critical Control Point certification (hereafter referred to as the HACCP certification), so as to enhance the enterprise's quality control.

Article 18

The ex-factory food for sale shall undergo pre-packaging or packaging in other forms, and the materials used for packaging shall be clean and safe, and in line with the requirements in relevant national laws, regulations and standards.

The ex-factory food for sale shall possess such label and mark as are in line with the requirements in relevant national laws, regulations and standards.

Article 19

The container, packaging, facility, equipment, detergent and disinfectant used for the stockpiling, transportation and loading and unloading of food shall be kept clean, and from contaminating food, and meet the requirements for guaranteeing food quality safety.

Article 20

These activities as follows shall be prohibited in food manufacturing and processing of an enterprise:

(1)

Using or misusing food additives against the provisions in the national standard concerned; and

(2)

Using inedible raw materials in food manufacturing, using inedible chemicals or using non-food as food; and

(3)

Using such meat as is uninspected or fails to pass the inspection in food manufacturing, using such poultry, livestock, beasts, aquatic animals as have died of diseases, toxication or other unknown causes, manufacturing food containing pathogenic parasites and microbes, or microbe toxins exceeding the national limitation standards; and

(4)

Mixing impurities into or adulterating food, passing a fake product as a genuine one, a defective product as a high-quality one, or an unqualified product as a qualified one; and

(5)

Counterfeiting the place of origin for food, counterfeiting and unauthorizedly using the name and address of another enterprise and the quality symbol; and

(6)

Manufacturing and using such food and its related products as are publicly eliminated by the State.

Chapter III Food Manufacturing Permit

Article 21

The AQSIQ shall be responsible for the nationwide overall administration of food manufacturing permit, for the permit of high-risk food manufacturing, for determining such product as is subject to the examination and permit-issuance and the related detailed measures by the quality and technology supervision authorities at the level of a province, autonomous region and municipality under direct control of the Central Government (hereinafter referred to as the provincial level), and for supervising and guiding the food manufacturing permit work at the provincial level.

The provincial quality and technology supervision authorities shall, in accordance with the overall arrangement of the AQSIQ, conduct, according to law, the work of food manufacturing permit with its jurisdiction, and shall be responsible for the examination and permit-issuance.

The prefectural quality and technology supervision authorities shall, entrusted by the AQSIQ and the provincial quality and technology supervision authorities, be, with its jurisdiction, responsible for the handling of food manufacturing permit, the examination and verification of the enterprise's requisite conditions, the inspection of product quality and the delivery of the food manufacturing permit.

The quality and technology supervision authorities at every level shall, in accordance with the principle of power with corresponding responsibility and of subsidiarity, assume the responsibility for the work of food manufacturing permit respectively.

Article 22

The AQSIQ shall, with reference to the conditions stipulated in Chapter II of these Rules and in accordance with the different peculiarities and related standards for different kinds of food, formulate and promulgate the general rules for the examination of food manufacturing permit and the detailed rules for the examination of food manufacturing permit for various kinds of food, and formulate provisions on the detailed requirements for food manufacturing permit. And the detailed rules for the examination of food manufacturing permit for various kinds of food shall, in accordance with the stipulated procedure, be promulgated and implemented in turn.

Article 23

The food manufacturing and processing enterprise shall, in accordance with the principle of territorial jurisdiction, advance, within the required period, the application for the issuance of food manufacturing permit to the provincial or prefectural quality and technology supervision authorities of where this enterprise concerned is located

The food manufacturing and processing enterprise, after obtaining its business license, shall separately apply for the food manufacturing permit, whose business scope shall cover such products as are subject to the applied permit.

Article 24

The food manufacturing and processing enterprise, when applying for the food manufacturing permit, shall provide relevant documents as required. Any unit shall not, with the exception of the limitation conditions stipulated in laws and administrative regulations, attach additional conditions to refrain the enterprise concerned from applying for the food manufacturing permit, and shall not require the applicant to submit such technical documents and other documents as are not related to the application.

Article 25

After receiving an application, the provincial/prefectural quality and technology supervision authorities, shall, within five days, finish the examination of the application document. An enterprise, whose application document accords with the requirements, shall be issued a Decision of Accepting the Application for an Administrative License; and an enterprise, whose application document fails to accord with the requirements, shall be issued a Notice for Redressing the Application Document for an Administrative License, which informs once and for all the applicant of all the contents needed to be redressed, informing the enterprise to redress it within 20 days; and the application shall be deemed as being withdrawn if the enterprise fails to redress within the time limit.

Where a food manufacturing permit, according to law, is not required for an applied item, or is not within the jurisdiction of these authorities, the applicant shall be informed of refusal, and be issued a Decision of Rejecting the Application for an Administrative License, or shall be informed of the authorities to which this application is subject.

Article 26

As of the date of accepting the enterprise's application for food manufacturing permit, the AQSIQ or the provincial quality and technology supervision authorities shall, within 60 days, make the decision of accepting/rejecting the license.

The time needed for product testing (including the time for the delivery of sample, the inspection by the inspection authorities, and the disagreement treatment) shall not be integrated into the time given above.

Article 27

After the issuance of the Decision of Accepting the Application for an Administrative License, the provincial/prefectural quality and technology supervision authorities shall organize an examination team, which shall, in accordance with the general and detailed rules for the examination of food manufacturing permit, finish, within 20 days, the on-scene examination, which shall generally be no more than 2 days, on the enterprise's requisite conditions and its ex-factory inspection capacity. And the quality and technology supervision authorities of where the enterprise is located shall send observers to monitor the inspection work. The chief of an examination team shall assume overall responsibility for the work.

Where an enterprise passes the on-scene examination, an examination team shall, in accordance with the provisions in the general and detailed rules for the examination of food manufacturing permit, conduct an on-scene selection and sealing-up of a sample, and inform the enterprise of the names and contact methods of the inspection institutions eligible to the inspection task for permit-issuance to the product hereof, which are up to the choice of the enterprise itself.

The examination personnel, when conducting an on-scene examination on an enterprise, shall not create difficulties for the enterprise concerned, shall not seek and take any article of property of the enterprise concerned, and shall not seek any other inappropriate interests.

Article 28

An enterprise shall, within 7 days as of the date of sealing-up, deliver the sample to the inspection institution, which shall, after receiving the sample, conduct inspections in accordance with the stipulated standards and requirements, and finish the inspection within 15 days (excluding those subject to special requirements).

Article 29

Where an enterprise disagrees with the inspection result, it may, within 15 days as of the date of the reception of the inspection result, advance an application for a re-inspection to the inspection-organizing quality and technology supervision authorities or the quality and technology supervision authorities at the next higher level. The quality and technology supervision authorities handling the application shall, within 5 days, formulate a written reply of acceptation/rejection. With the exception that a re-inspection is not allowed by the provisions in the national standards, an eligible re-inspection shall be timely conducted.

A re-inspection shall use the sample sealed up by an examination team, and shall be conducted in accordance with the former inspection program. And the inspection institution undertaking the re-inspection shall be decided by the quality and technology supervision authorities accepting the re-inspection application among the qualified inspection institutions.

Article 30

The enterprise's application document and the document of the on-scene examination and product testing, which are subject to the examination by the prefectural quality and technology supervision authorities, shall, within 30 days as of the date of acceptance, be submitted to the provincial quality and technology supervision authorities.

The provincial quality and technology supervision authorities in charge of the examination and approval shall summarize and examine the enterprise's documents and make a decision of granting a license or not in accordance with relevant provisions.

The enterprise's application document and the document of the on-scene examination and product testing, which are subject to the examination by the AQSIQ, shall, within 40 days as of the date of acceptance, be submitted by the provincial quality and technology supervision authorities to the AQSIQ, which shall make a decision of granting a license or not in accordance with relevant provisions.

A pre-license selective inspection shall, in accordance with the provisions in Article 26 of these Rules, be conducted before the AQSIQ and the provincial quality and technology supervision authorities make the decision of granting a license or not, or before the provincial quality and technology supervision authorities submit the enterprise's documents.

Article 31

With regard to such an enterprise as passes an on-scene examination and a product testing, the AQSIQ or the provincial quality and technology supervision authorities shall make a decision of granting a manufacturing permit, and issue to the enterprise hereof a food manufacturing permit and its copy within 10 days as of the date of the decision concerned.

With regard to such an enterprise as fails to pass an on-scene examination and a product testing, the AQSIQ or the provincial quality and technology supervision authorities shall make a decision of not granting a manufacturing permit, and issue to the enterprise hereof a Decision of Rejecting an Administrative License within 10 days as of the date of the decision concerned.

Article 32

The AQSIQ or the provincial quality and technology supervision authorities shall make publicly known such an enterprise as obtains a manufacturing permit within its jurisdiction, and timely inform the relevant authorities of public health, and industry and commerce etc. of the issuance of a food manufacturing permit.

Article 33

Where the food manufactured and processed by an export enterprise of food manufacturing and processing is sold within the territory of the People's Republic of China, a food manufacturing permit shall be applied for in accordance with the provisions in these Rules. Such an enterprise as obtained the Hygienic Registration Certificate for Export Food issued by the Certification and Accreditation Administration of the People's Republic of China and the exit-entry inspection and quarantine authorities, when applying for a food manufacturing permit, may be exempted from an on-scene examination on an enterprise's requisite conditions.

Such an enterprise as passed the HACCP certification and other state-promoted food certifications, when applying for a food manufacturing permit, may, in accordance with the principle of non-overlapping, be exempted from an on-scene examination on an enterprise's requisite conditions or subject to a simplified one.

Article 34

The term of validity for a food manufacturing permit is of 3 years. Where a term of validity expires and an enterprise continues manufacturing, the enterprise hereof shall, within 6 months before the term of validity expires, advance an application of re-issuance to the quality and technology supervision authorities which issued the food manufacturing permit. And the quality and technology supervision authorities shall, in accordance with the stipulated procedure, examine the enterprise hereof and reissue a new permit.

Article 35

Where the relevant standards and requirements for a product undergo changes during the term of validity of a food manufacturing permit, the provincial/prefectural quality and technology supervision authorities shall, in accordance with the unified requirements of the AQSIQ, conduct a necessary on-scene examination and product testing.

Where the manufacturing conditions, inspection means and technology or technique of an enterprise undergo changes, the enterprise hereof shall, within 20 days as of the date of these changes, advance an application. And the provincial/prefectural quality and technology supervision authorities shall, in accordance with the provisions in the general and detailed rules for the examination of food manufacturing permit, re-conduct an on-scene examination and product testing.

Article 36

The AQSIQ and the provincial/prefectural quality and technology supervision authorities shall construct an administrative system of archives of food manufacturing permit, and timely archive the related documents and permit-issuances. And the archives shall be kept up for 4 years.

Chapter IV Inspection of Food Quality Safety

Article 37

A food manufacturing and processing enterprise shall exert a system of check and acceptance on the purchases of raw materials, food additives, packaging materials, containers and other articles used in food manufacturing and processing, shall not use those below the requirements for quality safety in food manufacturing and processing.

Article 38

The ex-factory food shall undergo inspection, and those that are uninspected or fail to pass an inspection shall not be subject to ex-factory sales.

An enterprise with an ex-factory inspection capacity may itself conduct, as required, an ex-factory inspection; and an enterprise without an ex-factory inspection capacity shall entrust a qualified inspection institution to conduct an ex-factory inspection. Such food as is subject to a market access system for food quality safety shall be subject to the provisions in the detailed rules.

A self-inspection enterprise shall annually send its sample to an inspection institution designated by the quality and technology supervision authorities to undergo a comparing inspection.

Article 39

The product of a food manufacturing and processing enterprise shall be subject to a compulsory inspection system. And the quality and technology supervision authorities shall decide the frequency of the compulsory inspection and carry it out.

The frequency of inspection for such a large-scales enterprise with a stable product quality as passed the HACCP certification and such an enterprise as consecutively passed the national and provincial supervisory selective inspections shall be decreased.

The frequency of inspection for such an enterprise as is not yet subject an administration of food manufacturing permit, and as possesses no control requirements and means and a substandard ex-factory inspection capacity shall be increased.

Article 40

An inspection institution undertaking the inspection task of food quality safety as stipulated in these Rules shall be legally-established or legally-authorized, undergo a metrological certification, an accreditation by examination or laboratory, and be designated by the quality and technology supervision authorities above the provincial level.

The quality and technology supervision authorities at every level shall, in accordance with the relevant provisions in the Measures for the Implementation of the Regulations of the People's Republic of China for the Administration of the Manufacturing Permit for Industrial Products etc., conduct an administration of the inspection institution undertaking the food inspection task as stipulated in these Rules.

Article 41

An inspection institution undertaking the food inspection task shall carry out its business in accordance with the requirements in relevant national standards and technical regulations etc.. An inspection institution shall be objective and impartial, timely formulate an inspection report and be accountable to it.

Article 42

An inspection institution and its working staff, when carrying out its business, shall be in line with the principle of good faith and facilitating the enterprise, proving the enterprise with a reliable and convenient inspection service, and shall not hang up and create difficulties for the enterprise.

An inspection institution and its working staff shall not engage in the manufacturing and sale activities related to the products categorized in inventories for inspection, and shall not recommend or monitor the making and cancellation of the products categorized in inventories in their names.

Chapter V Market Access Symbol for Food Quality Safety and Food Manufacturing Permit

Article 43

Containing an original copy and a duplicate, a food manufacturing permit shall specify the name and locality of an enterprise, the manufacturing locality, the product name, the serial number of this permit, the date of issuance and the term of validity etc.. And the duplicate of a food manufacturing permit shall be used by the quality and technology supervision authorities to record basically the supervision and inspection that an enterprise received.

The pattern of a food manufacturing permit (Annex 1) shall be subject to the unified determination by the AQSIQ. A food manufacturing permit shall be uniformly printed by the AQSIQ and be stamped with the seal of the examination and approval authorities for food manufacturing permit.

Article 44

Where the name of an enterprise undergoes change, the enterprise hereof shall, within 20 days as of the date of change, advance an application for changing the name in its food manufacturing permit to the quality and technology supervision authorities that handled its application for the permit hereof. And the handling quality and technology supervision authorities shall, within 10 days as of the date of acceptance, finish the examination for name change and submit the documents to the former permit-issuance authorities, which shall examine and approve within 10 days.

Article 45

An enterprise shall well keep its food manufacturing permit, and shall publish an announcement in the newspaper above the provincial level if the permit is lost or unidentifiable due to damages or the force majeure and other causes, and report this to the provincial quality and technology supervision authorities at the same time. And the quality and technology supervision authorities shall timely handle the enterprise's application for permit re-issuance, and the provincial quality and technology supervision authorities shall handle the formalities of permit re-issuance as required.

Article 46

The market access symbol for food quality safety i.e. the symbol for food manufacturing permit, is a quality symbol, and shall be represented by the English abbreviation of quality safety---"QS", whose pattern shall be uniformly formulated by the AQSIQ (please refer to Annex 2, hereinafter referred to as the QS symbol).

Article 47

A QS symbol shall be printed (pasted) on the packaging or label of the food subject to the market access system for food quality safety before leaving factory. Those without the QS symbol shall not leave factory for sale.

Article 48

The QS symbol used by an enterprise indicates that it promises that its product is qualified after inspection, and in line with the basic requirements of food quality safety.

Where a quality problem, not due to the customer's improper use or storage, occurs in the food with a QS symbol printed (pasted) before its expiration date, the manufacturer and the seller shall assume their liabilities in accordance with their own duties and laws and regulations.

Article 49

An QS symbol used by an enterprise may, in accordance with the proportion of the pattern and the actual needs, be magnified or shortened but bear no distortions and color changes. And the QS symbol shall be printed (pasted) by a food manufacturing and processing enterprise itself.

Article 50

The serial number of a food manufacturing permit shall be comprised of the Latin letter QS and 12-digit Arabic numerals.

Article 51

An enterprise that obtained a food manufacturing permit shall print (paste) the serial number of its permit hereof on the packaging or label of its product.

Article 52

Any unit and individual shall not forge, alter and utter a food manufacturing permit and its serial number, and a QS symbol. An enterprise that obtained a food manufacturing permit shall not lease, lend or transfer by other means a food manufacturing permit and its serial number, and a QS symbol.

Article 53

The AQSIQ and the provincial quality and technology supervision authorities shall, in accordance with the performance of an enterprise that obtained a food manufacturing permit, timely make a decision of revoking, recalling and cancelling its permit hereof, and make publicly known the cancellation of a permit hereof.

Chapter VI Supervision of Food Quality Safety

Article 54

A food manufacturing and processing enterprise shall continually possess the requisite conditions for guaranteeing food quality safety, and guarantee a constant and stable manufacturing of qualified food.

A food manufacturing and processing enterprise shall be accountable to the quality safety of its manufactured and processed food, and clearly promise not to misuse food additives, not to use non-food raw materials in food manufacturing and processing, not to use toxic and hazardous articles in food manufacturing and processing and not to manufacture counterfeited and low-quality food.

Article 55

An enterprise, when purchasing food raw materials and food additives, shall check their labels and marks, demand the supplier unit of a certificate of quality (passing a self-inspection or an entrusted inspection), and establish a purchase account. And the food manufacturing and processing enterprise shall file with the quality and technology supervision authorities at the county level of where the enterprise is located for record its use of food additives and other items required to be filed for record by the State.

An food manufacturing and processing enterprise, when using a new kind of food additives, and of food containers, packaging materials and food utensils and equipments that are manufactured with new raw materials, shall, before use, seek a safety evaluation report issued by a safety evaluation institution above the provincial level and record it for inspection.

A food manufacturing and processing enterprise shall establish a manufacturing record and a sale record, and the latter shall give a clear indication of the name, specification, batch number of food, the name of a supplier unit, the sales amount and the date of sales etc..

An enterprise shall establish archives for food quality safety, saving the purchase/sale records, manufacturing records, inspection records and other documents related to food quality safety. And the archives hereof shall be kept for 3 years.

Article 56

Where an enterprise that obtained a food manufacturing permit consecutively ceases for more than 1 year the manufacturing and processing of the product subject to the permit hereof, it, when restarting the manufacturing and processing, shall advance an application for a on-scene re-inspection to the quality and technology supervision authorities that previously handled its application for a food manufacturing permit.

Article 57

A food manufacturing and processing enterprise, when using new resources in food manufacturing, shall, before going into manufacturing, seek a safety evaluation report from a safety evaluation institution above the provincial level, and report the evaluation result to the quality and technology supervision authorities at the county level of where the enterprise is located. And the enterprise hereof shall be accountable to the authenticity of the report hereof.

Article 58

An enterprise that obtained a food manufacturing permit shall, within the term of validity of the permit hereof and within 1 month before the permit hereof performs for 1 year, submit an annual report on the requisite conditions for continually guaranteeing food quality safety to the quality and technology supervision authorities at the county level of where the enterprise hereof is located.

Article 59

Where food is entrusted to be manufactured and processed, the entruster and the entrustee shall respectively go to the prefectural quality and technology supervision authorities of where the two parties are located for record, providing the business licenses of the two parties and the duplicated copies of their contract of entrustment.

Where the product of an entrusted processing is subject to the administration of the market access for food quality safety, and besides the requirements as mentioned above, the entrustee shall be an enterprise that obtained an effective food manufacturing permit, and all its manufactured and processed food shall be handed over to the entruster for sale, and the duplicated copy of the food manufacturing permit of the entrustee shall also be submitted when put on record. And the food manufactured through an entrusted processing shall, in accordance with the provisions for product labeling and marking, contain the serial number of the food manufacturing permit and the name and address of the manufacturer.

Article 60

The quality and technology supervision authorities shall conduct a periodical or aperiodic supervision and inspection on the food quality safety and hygienic situations and on the requisite conditions of the food manufacturing and processing enterprise for continually guaranteeing food quality safety, and shall, through the circuit inspection, tightened inspection, revisit, compulsory inspection, supervisory selective inspection, inspection through an annual report, law-enforcement inspection and other means, strengthen the supervision and inspection so as to urge the enterprise to regulate its manufacturing and business activities.

The quality and technology supervision authorities at every level, when conducting supervision and inspection on the enterprise, shall not impede its normal manufacturing and business activities, and shall not seek or take its articles of property or seek other interests.

Article 61

The quality and technology supervision authorities at every level shall establish administrative archives of quality safety concerning the food manufacturing and processing enterprise, detailing its basic conditions and situation of product quality safety and the supervision on the enterprise, exerting a dynamic administration.

Article 62

The quality and technology supervision authorities at every level shall exert a classified supervision and administration system on a food manufacturing and processing enterprise, and determine, in accordance with the manufacturing conditions, management level, product quality performance and other factors of the food manufacturing and processing enterprise within their jurisdiction, the quality safety grade of an enterprise, exerting a classified administration.

Article 63

A circuit inspection shall be conducted on a food manufacturing enterprise and its manufacturing and business activities, and when such an inspection is conducted, the implementation of the enterprise of these Rules shall be recorded according to facts. And the problem detected during such an inspection shall be treated in accordance with relevant provisions.

Article 64

The AQSIQ and the quality and technology supervision authorities at every level shall, in accordance with the peculiarities and the product quality situation of different kinds of foods, conduct a supervisory selective inspection on food quality safety, and such an inspection shall be conducted in accordance with relevant provisions.

The foci for a supervisory selective inspection shall rest in the field where exists an orientational quality problem, in the enterprise with an unstable quality, and in microbes, heavy metals, additives, toxic and hazardous articles and other important indicators.

Article 65

The quality and technology supervision authorities at every level shall conduct tightened inspections on food with quality safety problems.

Article 66

The quality and technology supervision authorities at every level shall conduct examinations on the annual report submitted by an enterprise that obtained a food manufacturing permit, and if necessary, an on-scene examination and product testing shall be conducted on the enterprise.

Article 67

The quality and technology supervision authorities at every level shall conduct revisits on the amelioration of situations against the requisite conditions existing in an enterprise that obtained a food manufacturing permit, and the revisits shall be archived for record.

Article 68

The quality safety problems without its own jurisdiction detected by the quality and technology supervision authorities at every level during its supervision and administration shall be reported to the quality and technology supervision authorities possessing the jurisdiction hereof.

A grave event concerning food quality safety detected shall immediately be reported to the superior quality and technology supervision authorities, and may also directly be reported to the AQSIQ.

Article 69

The AQSIQ and the provincial quality and technology supervision authorities shall establish a risk pre-warning mechanism for food quality safety composed of an information collection, a risk evaluation and a risk pre-warning release etc..

Article 70

The quality and technology supervision authorities at every level shall establish a rapid-reaction mechanism for events concerning food quality safety, and shall launch immediately an investigation and product analysis, adopt measures to control the expansion of damages, and conduct pertinently a supervision and administration, towards a suddenly-occurring grave event concerning food quality safety.

Article 71

The unsafe food shall be recalled. Where a food manufacturing and processing enterprise finds a serious quality safety problem in its product, the enterprise hereof shall initiatively recall its sold product with such a problem, shall, if failing to do so, be ordered to recall by the quality and technology supervision authorities of where the enterprise is located, and shall, if refusing to do so, be made publicly known to recall by the quality and technology supervision authorities above the provincial level.

Article 72

The AQSIQ and the provincial quality and technology supervision authorities shall establish a system of making publicly known an enterprise with serial illegal activities, periodically making publicly known the name of an enterprise manufacturing counterfeited and low-quality food.

Article 73

The AQSIQ and the provincial quality and technology supervision authorities shall, through checking an inspection report, comparing an inspection result and other means, timely conduct supervision and examination on the objectivity and impartiality of the inspection procedure and report of an inspection institution.

Where the inspection personnel, the inspection institution and its working staff creates deliberately difficulties for an enterprise, the enterprise hereof shall be entitled to complaint to the AQSIQ and the quality and technology supervision authorities above the county level, who shall timely conduct an investigation and prosecution after receiving a complaint.

Chapter VII Examination Personnel and Inspection personnel

Article 74

The State shall exercise a qualification administration system on the examination personnel engaging in examining the requisite conditions of an enterprise, and a professional administration system on the food inspection personnel.

The examination personnel shall include the registration examiner of food manufacturing permit, high examiner and the technical expert.

Article 75

The AQSIQ shall be responsible for uniformly formulating the assessment criteria for the examination personnel and the inspection personnel, uniformly train the teaching staff for the examination personnel and the inspection personnel, and uniformly organize the assessment registration for the registration examiner and the high examiner. And the provincial quality and technology supervision authorities shall be responsible for organizing the training of the examination personnel and the inspection personnel within its jurisdiction, and for the assessment and license issuance of the inspection personnel.

Article 76

The AQSIQ shall uniformly prescribe the administrative measures of qualification registration for the inspection personnel, and the provincial quality and technology supervision authorities shall be concretely responsible for the registration administration of the inspection personnel.

Article 77

The provincial quality and technology supervision authorities may, as circumstances demanded, let a technical expert participate in an on-scene examination.

A technical expert refers to a professional technical person who fails to obtain an examiner registration certificate, however, is able to offer a technical consultancy to an on-scene examination on the requisite conditions of an enterprise. A technical expert, when on-scene, shall not be with an examination team, and not participate in the decision of an examination result.

A technical expert shall possess a certain qualification, and be approved by the provincial quality and technology supervision authorities and recorded by the AQSIQ. Any unapproved and unrecorded person shall not participate in an examination as a technical expert.

Article 78

The examination personnel and the inspection personnel shall start their work after being registered or approved and recorded. And anyone who fails to obtain a corresponding qualification certificate through passing an assessment shall not engage in the examination or inspection task.

The chief of an examination team shall be approved by the provincial quality and technology supervision authorities and recorded by the AQSIQ.

Chapter VIII Legal Liabilities

Article 79

Any food manufacturing enterprise who is under one of the following acts shall be ordered to stop its manufacturing and sale, confiscated of the product manufactured and sold against laws and regulations, and imposed a fine of equivalent to but not more than 3 times the value of the illegally manufactured and sold products (including the sold and unsold products, the same below); and if there are legal gains, they shall be confiscated, if a crime is constituted, the criminal liability shall be investigated according to law:

(1)

Manufacturing and processing food subject to an administration of a food manufacturing permit without such a permit hereof; and

(2)

Continue to manufacture and process food subject to an administration of a food manufacturing permit with a cancelled or expired permit hereof; and

(3)

Manufacturing and processing food subject to an administration of a food manufacturing permit beyond the business scope stipulated in such a permit hereof.

Article 80

Such an enterprise that obtained a food manufacturing permit, when undertaking changes in its manufacturing conditions, inspection methods, and manufacturing technology or technique, as fails to go through the formalities of a reapplication for examination in accordance with the provisions in these Rules shall be ordered to stop its manufacturing and sales, confiscated of its illegally-manufactured and sold products, and go through the relevant formalities within a limited period, and, if failing to go through such formalities hereof when the period hereof expires, shall be imposed a fine of not more than 3 times the value of its illegally manufactured and sold products; if there are legal gains, they shall be confiscated, and if a crime is constituted, the criminal liability shall be investigated according to law.

Such an enterprise that obtained a food manufacturing permit, when undertaking change in its name, as fails to go through the formalities of change in accordance with the provisions in these Rules shall be ordered to go through the relevant formalities within a limited period, and, if failing to go through such formalities hereof when the period hereof expires, shall be ordered to stop its manufacturing and sales, confiscated of its illegally manufactured and sold products, and imposed a fine of not more than the equivalent value of its illegally manufactured and sold products; if there are legal gains, they shall be confiscated.

Article 81

Such an enterprise that obtained a food manufacturing permit as fails to submit its annual report in accordance with the provisions in these Rules shall be ordered to redress with a limited period, and, if failing to do so when the period hereof expires, shall be imposed of a fine of not more than RMB 5000 Yuan.

Article 82

Such an enterprise that obtained a food manufacturing permit as fails to label a QS symbol and the serial number of its food manufacturing permit in accordance with the provisions in these Rules shall be ordered to redress with a limited period, and, if failing to do so when the period hereof expires, shall be imposed of a fine of not more than 30% of the equivalent value of its illegally manufactured and sold products; if there are legal gains, they shall be confiscated, and if the circumstances are serious enough, its food manufacturing permit shall be revoked.

Article 83

Such an enterprise that obtained a food manufacturing permit as leases, lends or transfers the permit hereof and its serial number and the QS symbol shall be ordered to redress within a limited period and imposed a fine of not more than RMB 200 thousand Yuan; if the circumstances are serious enough, its food manufacturing permit shall be revoked.

Anyone who illegally accepts and uses the food manufacturing permit and its serial number and the QS symbol offered by others shall be ordered to stop its manufacturing and sales, confiscated of its illegally-manufactured and sold products, and imposed a fine of equivalent to but not more than 3 times the value of the illegally manufactured and sold products; if there are legal gains, they shall be confiscated, and if a crime is constituted, the criminal liability shall be investigated according to law.

Article 84

The product of such an enterprise that obtained a food manufacturing permit as fails to pass the national or provincial supervisory selective inspection shall be ordered to redress within a limited period, and, if failing to pass an re-inspection when the period hereof expires, shall be revoked of its food manufacturing permit.

The product of such an enterprise that obtained a food manufacturing permit as fails to pass the national or provincial supervisory selective inspection in such items stipulated in the compulsory standards as safety and hygiene etc. or as twice fails to pass the inspection hereof consecutively in the items indicating its characteristics and performance shall be revoked of its food manufacturing permit.

Article 85

Such an enterprise that obtained a food manufacturing permit as meets with an accident due to the unqualified indicators for its food quality safety and other factors and as thus causes serious consequences, shall be revoke of its food manufacturing permit and be treated in accordance with relevant laws and regulations.

Article 86

Anyone who forges, alters, and utters a food manufacturing permit and its serial number and a QS symbol shall be ordered to redress, confiscated of its illegally manufactured and sold products, and imposed a fine of equivalent to but not more than 3 times the value of the illegally manufactured and sold products; and if there are legal gains, they shall be confiscated, if a crime is constituted, the criminal liability shall be investigated according to law.

Article 87

Such a food manufacturing and processing enterprise as obtains a food manufacturing permit through fraudulence, bribing and other illegal means shall be revoked of its manufacturing permit, imposed a fine of below RMB 20 thousand Yuan, refrained from reapplying for a food manufacturing permit within 3 years, and investigated for a criminal liability if a crime is constituted.

Such a food manufacturing and processing enterprise as applies for a food manufacturing permit though concealing relevant situations and providing unauthentic documents shall not be handled or not be granted a permit, and shall be granted a warning, and refrained from reapplying for a food manufacturing permit within 1 year.

Article 88

Such an enterprise that obtained a food manufacturing permit as conceals relevant situations, provides unauthentic documents or refuses to offer the authentic documents that indicating its actual activities to the quality and technology supervision authorities in charge of the supervision and inspection shall be ordered to redress and imposed a fine of below RMB 30 thousand Yuan.

Article 89

Such a food manufacturing and processing enterprise as fails to keep constantly the required environmental conditions, hygienic conditions, workshop locality, equipments and installations or the inspection conditions shall be ordered to redress with a limited period and imposed a fine of below RMB 5000 Yuan, and, if it failing to redress when the period hereof expires, the related authorities shall be advised to revoke its related administrative licenses and the food manufacturing permit, if obtained, shall be revoked.

Article 90

Such a food manufacturing and processing enterprise as uses products without a manufacturing permit that are subject to an administration of such a permit hereof in its food manufacturing and processing activities shall be ordered to redress and imposed a fine of more than RMB 50 thousand Yuan but less than RMB 200 thousand Yuan; if there are illegal gains, they shall be confiscated. And such an enterprise that obtained a food manufacturing permit as commits such offenses with serious circumstances shall be revoked of the permit hereof.

Where the party concerned has enough evidences to prove its unawareness that the products concerned without a manufacturing permit are subject to an administration of such a permit hereof, and is able to detail the purchase origin according to facts, the penalty may be lessened or mitigated.

Article 91

Anyone who mixes impurities into or adulterating food, and passes a fake product as a genuine one, a defective product as a high-quality one, or an unqualified product as a qualified one, shall be punished in accordance with the provisions in Article 50 of the Product Quality Law of the People's Republic of China. And such an enterprise that obtained a food manufacturing permit as commits such an offense shall be revoked of its permit hereof.

Article 92

Anyone who manufactures and uses in manufacturing such food and its related products as are publicly eliminated by the State shall be punished in accordance with the provisions in Article 51 of the Product Quality Law of the People's Republic of China. And such an enterprise that obtained a food manufacturing permit as commits such offenses with serious circumstances shall be revoked of the permit hereof.

Article 93

Anyone who forges a place of origin of product, forges or utters the name and address of other enterprises, forges or utters the certification symbol and other quality symbols shall be punished in accordance with the provisions in Article 53 of the Product Quality Law of the People's Republic of China. And such an enterprise that obtained a food manufacturing permit as commits such offenses with serious circumstances shall be revoked of the permit hereof.

Article 94

Any food manufacturing enterprise who is under one of the following acts shall be ordered to redress with a limited period, and, if it fails to do so when the period hereof expires and the circumstances are serious, shall be ordered to stop its manufacturing and sales, and imposed a fine of less than RMB 30 thousand Yuan. And such an enterprise that obtained a food manufacturing permit as commits such offenses with serious circumstances shall be revoked of the permit hereof.

(1)

Entrusting an enterprise that fails to obtain a food manufacturing permit to manufacture food subject to an administration of the permit hereof; and

(2)

Failing to conduct an ex-factory inspection in accordance with the provisions in these Rules; and

(3)

Using in food manufacturing and processing such food as are overdue, non-serviceable, rotten, filthy, recycled, and polluted in other ways and inedible raw materials against the provisions; and

(4)

Using new resources in food manufacturing, a new kind of food additives, and food containers, packaging materials and food utensils and equipments that are manufactured with new raw materials, while being unable to present a safety evaluation report; and

(5)

Failing to put on file food of entrusted processing or to label the packaging of the food manufactured by entrusted processing in accordance with the provisions in these Rules.

Article 95

Any food manufacturing enterprise who is under one of the following acts shall be ordered to redress with a limited period, and, if it fails to do so when the period hereof expires and the circumstances are serious, shall imposed a fine of less than RMB 5,000 Yuan.

(1)

Failing to conduct a compulsory inspection, a comparing inspection or a tightened inspection; and

(2)

Conducting manufacturing without a standard or not in line with the standards; and

(3)

Failing to exercise a system of check and acceptance on the purchases of raw materials and establish a purchase account in accordance with the provisions in these Rules; and

(4)

Failing to put on file the use of food additives or other items in accordance with the State provisions; and

(5)

Having no manufacturing records or sale records.

Article 96

Any food manufacturing and processing enterprise who is under the acts as mentioned in Section 2), 3), 4), 5), and 6) of Article 20 of these Rules shall be treated in accordance with the provisions in Article 42 of the Food Hygiene Law of the People's Republic of China.

Article 97

Any food manufacturing and processing enterprise who, against the provisions, misuses food additives, food containers, packaging materials, food utensils, equipments, detergents and disinfectants shall be treated in accordance with the provisions in Article 44 of the Food Hygiene Law of the People's Republic of China.

Article 98

Any enterprise whose food manufacturing permit was revoked shall be refrained from a reapplication for such a permit within 3 years.

Article 99

The quality and technology supervision authorities above the county level, when considering, with reference to its acquired evidence about suspicion of illegality or reporting, that an enterprise that obtained a food manufacturing permit undertakes such activities as shall lead to the revocation of its permit hereof according to law, shall immediately withhold temporarily the permit hereof.

The time limit for a temporary withholding of a permit shall be of 7 days (excluding the time for a product inspection), and the temporarily withheld permit shall be timely returned to the enterprise concerned if an investigation according to law leads to a decision against a revocation.

Article 100

Where such a inspection and testing instrument of an enterprise or an inspection institution as falls within a compulsory calibration scope, fails to be applied for a calibration, or such a measurement instrument as falls within a noncompulsory calibration scope fails to be periodically self-calibrated or to be sent to an institution of measurement examination and determination for a periodical calibration, or continues to be used after failing to pass a calibration, the party concerned shall be punished in accordance with the provisions in Article 46 of the Rules for the Implementation of the Metrological Law of the People's Republic of China.

Article 101

Such an inspection institution undertaking the product inspection task for permit issuance as forges an inspection conclusion or issues an unauthentic attestation shall be ordered to redress, and imposed a fine of more than RMB 50 thousand Yuan and less than RMB 100 thousand Yuan, and its directly responsible person in charge and other directly responsible persons shall be imposed a fine of more than RMB 10 thousand Yuan and less than RMB 50 thousand Yuan; if there are illegal gains, they shall be confiscated; if the circumstances are serious, its qualification for inspection shall be revoked; and if a crime is constituted, the criminal liability shall be investigated according to law.

Such an inspection institution and its inspection staff as engages in the relevant manufacturing and sale activities related to the food subject to an administration of a market access system for quality safety that is also subject to its inspection, or as recommends or monitors in its own name the making and cancellation of the food subject to an administration of a market access system for quality safety that is also subject to its inspection shall be imposed a fine of more than RMB 20 thousand Yuan and less than RMB 100 thousand Yuan; if there are illegal gains, they shall be confiscated; and if the circumstances are serious, its qualification for inspection shall be revoked.

Article 102

The examination personnel and the inspection personnel fulfill their duties unscientifically and unfairly shall be granted necessary administrative sanctions of criticism, warning or transfer from their posts etc. according to the circumstances; if the circumstances are serious, their qualifications shall be abolished; and if a crime is constituted, the criminal liability shall be investigated according to law.

Article 103

Such an institution and its working staff engaging in the supervision and administration of food quality safety as violate laws and regulations shall be treated in accordance with the provisions in Article 60 , Article 61 , Article 62 , Article 63 and Article 64 of the Regulations of the People's Republic of China for the Administration of the Manufacturing Permit for Industrial Products.

Article 104

An administrative penalty of a revocation of a food manufacturing permit as stipulated in these Rules shall be decided by the provincial/prefectural quality and technology authorities. A revocation of such a food manufacturing permit as is examined and issued by the AQSIQ shall be uniformly reported to the AQSIQ for an approval by the provincial quality and technology supervision authorities in accordance with the stipulated procedure; and a revocation of such a food manufacturing permit as is examined and issued by the provincial quality and technology authorities shall be reported to the provincial quality and technology authorities for an approval by the prefectural quality and technology supervision authorities in accordance with the stipulated procedure.

The public health authorities in charge and the authorities of industry and commerce etc. at the same level shall be timely informed of an administrative penalty decision of a revocation of a food manufacturing permit.

The other administrative penalties as stipulated in these Rules shall be decided by the quality and technology authorities above the county level in accordance with their own powers and jurisdictions.

Article 105

Such a food manufacturing and processing enterprise as refuses to accept an administrative penalty that the administrative authorities make in accordance with these Rules shall advance an administrative reconsideration or an administrative procedure according to law.

Chapter IX Supplementary Provisions

Article 106

A food manufacturing and processing enterprise, when applying for the reception of a food manufacturing permit and undergoing the relevant product quality inspections, shall pay a fee in accordance with the relevant provisions of the State, and the charging standard shall be subject to the documents approved by the national and provincial price authorities.

Article 107

The time limit as stipulated in these Rules shall be calculated in workdays, excluding the legally-defined holidays.

Article 108

The AQSIQ shall be responsible for the interpretation of these Rules. These Rules shall enter into force as of the date of September 1, 2005, and the Measures for the Administration and Supervision of Food Quality Safety of the Food Manufacturing and Processing Enterprise promulgated by the AQSIQ on July 18, 2003 shall be abolished at the same time.

Annexes:

1.

Pattern for a Food Manufacturing Permit (Omitted)

2.

Pattern for a QS Symbol (Omitted)