Announcement of the General Administration of Quality Supervision, Inspection and Quarantine
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 enpost_titled 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
