3.2.1 Commodities Subject to
Statutory Inspection and Quarantine
The Catalogue of Import-Export Commodities Subject to
Compulsory Inspection and Quarantine lists the types of
commodities requiring entry-exit inspection and quarantine. It also
covers the contents of inspection. Provisions for the administration
of inspection and quarantine for different commodities promulgated
by China set out detailed regulations governing the bases, methods
and procedures of inspection and quarantine.
3.2.2 Technical Standards for Inspection and Quarantine
Inspection is conducted by AQSIQ according to the following
criteria: for import and export commodities listed in the catalogue,
inspection is carried out in accordance with mandatory national
standards; where relevant standards are not yet formulated,
inspection is carried out with reference to foreign standards
specified by the commodity inspection departments.
3.2.3 Supervision and Inspection of Foodstuffs
(a) Inspection of Imported Food
All imported food (including beverages, liquor and sugar), food
additives, food containers, packaging materials, and food utensils
and equipment must be declared to the inspection and quarantine
authorities for health supervision and inspection. Under the
management of inspection and quarantine authorities, imported food
is classified into different categories by hazard ratings and
inspected according to national health standards. Only those
foodstuffs that meet requirements can enter China.
(b) Inspection of Exported Food
All food for export (including finished products and raw materials
for human consumption and food prepared according to traditional
methods with medicinal ingredients) must undergo inspection.
Foodstuffs not inspected or not up to standard may not be exported.
(c) Registration of Imported Food and Animal and Plant
Products
CIQ is responsible for formulating, revising and publishing the
Catalogue of Imported and Exported Food and Animal and Plant
Products Subject to Health Registration. The products in the
catalogue mainly include processed food that can be consumed
directly, such as canned food, beverages, liquor and condiments, as
well as semi-finished products and raw materials, such as meat,
aquatic products and vegetables.
Foreign food manufacturers may apply for registration with CIQ
through the local food and hygiene authorities at their resident
country. Those that meet CIQ requirements will be added to CIQ's
list of countries and enterprises permitted to export food to China
and issued special quarantine and health registration codes.
(d) Registration of Exported Food and Animal and Plant
Products
All enterprises in China engaged in the processing and storage of
food for export as well as the slaughtering of animals and poultry
for export must first obtain a health licence from the local health
department and then apply to the inspection and quarantine
authorities for a registration certificate. Enterprises not granted
the registration certificate may not process, produce or store food
for export. Where overseas registration or recognition is required,
the enterprises must apply to CIQ which is responsible for the
unified handling of all the necessary foreign-related procedures.
Enterprises failing to obtain approval or recognition from the
importing country may not export food to that country.
3.2.4 Supervision and Inspection of Mechanical and
Electronic Products
(a) Scope of Mechanical and Electronic Products
The Statistical Handbook on the Import and Export of Mechanical
and Electronic Products (1999 Edition) compiled by the
Department of Mechanical and Electronic Products Import and Export
under the Ministry of Commerce includes a Catalogue of
Mechanical and Electronic Products, which CIQ uses as the basis
for defining the scope of mechanical and electronic products subject
to entry-exit inspection and supervision.
(b) Supervision and Inspection of Mechanical and Electronic
Products for Export
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Supervision by enterprise category
The inspection and quarantine authorities divide export
enterprises into four categories according to their
management standard and product quality:
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Enterprises with exemption certificates: the
mechanical and electronic products for export of
these enterprises are exempt from inspection; |
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Category
I enterprises: batch inspection rate 10-30%; |
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Category
II enterprises: batch inspection rate 40-70%; |
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Category
III enterprises: batch inspection rate 100%. |
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Bases for inspection
For mechanical and electronic products subject to mandatory
safety, health and environmental protection requirements,
their standards must not be below the mandatory requirements
set by the state. For other products, their standards can
follow those stipulated in the trade contracts.
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Certification
To facilitate exports, CIQ has introduced interim measures
governing export quality licensing for special cases in the
implementation of the export quality licensing system for
mechanical and electronic products. CIQ also encourages
enterprises to seek ISO9000, ISO14000 and other quality
certifications. Enterprises awarded certification by
institutions approved by the China National Accreditation
Board (CNAB) are exempt from factory inspection and such
certification may also serve as the basis for categorising
the enterprises concerned.
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Registration of production enterprises exporting complete
sets of equipment
China requires and encourages enterprises that produce
complete sets of equipment for export to register with the
local inspection and quarantine authorities. The inspection
and quarantine authorities provide technical guidance free
of charge to registered enterprises to help them meet
foreign technical and quality requirements and comply with
international practices in the course of production.
Inspection is carried out jointly and is charged
accordingly.
(c) Regulations for Inspection of Imported Mechanical and
Electronic Products
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On 1 August 2003, the China Compulsory Certification (CCC)
mark was implemented, while the old import commodities
safety and quality licensing system and electrical products
safety certification system were abolished. The CCC mark has
since replaced the CCIB mark for import commodities safety
and quality and the Great Wall mark for electrical products
safety. Products which have not been issued the compulsory
certification certificate and do not carry the CCC mark are
not allowed to be imported or sold.
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A system of filing for the record is adopted for used
mechanical and electronic products allowed to be imported.
Imported used mechanical and electronic products not meeting
the relevant requirements will not be filed. For the import
of used mechanical and electronic products involving safety,
hygiene and environmental protection, pre-shipment
inspection and inspection upon goods arrival are required.
As for other mechanical and electronic products, goods are
only inspected upon arrival. For imports which require
pre-shipment inspection, the filing organ would issue the
Record for Pre-Shipment Inspection of Imported Used
Mechanical and Electronic Products ("the Record"). For
imports which do not require pre-shipment inspection, the
filing organ would issue the Certificate for Exemption from
Pre-Shipment Inspection of Imported Used Mechanical and
Electronic Products ("the Exemption Certificate"). Upon
arrival of the used mechanical and electronic products at
the port, the consignee or its agent should present the
Exemption Certificate (original) or the Record (original),
Pre-Shipment Inspection Report (orginal), Pre-Shipment
Inspection Certificate (orginal) and other necessary
documents for customs clearance. After the entry-exit
inspection and quarantine authorities at the port of enty
has accepted the application for customs clearance, the
relevant documents would be examined and on-the-spot
inspection of goods may be conducted if necessary. For goods
meeting requirements, the Import Goods Clearance Slip is
issued, which will specify that the goods are used
mechanical and electronic products.
3.2.5 Supervision and Inspection of Drugs
The State Food and Drug Administration is responsible for the
supervision and inspection of drugs.
(a) Supervision and Inspection of Imported Drugs
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Registration of imported drugs
China implements a registration and approval system for
imported drugs. All imported drugs must obtain a
registration certificate from the State Drug Administration
(SDA). Manufacturers of the imported drugs must meet the
drug production and quality control standards in the
producing country as well as China's GMP requirements.
Imported drugs applying for registration in China must be
registered with the drug administration department and
granted approval for public sale in the producing country,
and must pass inspections by SDA-authorised port-of-entry
drug laboratories.
The China office or registration agent of the foreign drug
manufacturer is responsible for applying for imported drug
registration. They have to submit the Imported Drug
Registration Certificate Application Form together with
other required documents to SDA for examination and
approval. These offices or agents must be legitimate
establishments registered with the State Administration for
Industry and Commerce (SAIC).
After reviewing the quality and performing the necessary
clinical tests, SDA will grant an Imported Drug
Registration Certificate to the imported drugs in
question. This certificate is the official document for the
registration, import, sale and use of foreign drugs in
China.
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Filing of imports
Drugs must be imported through designated ports of entry and
the importer must register and file the import with the drug
administration at the port of entry. Any change in the
packaging as well as the form and content of labeling must
be reported to SDA.
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Application for inspection
Inspection organs: The port-of-entry drug laboratories set
up by SDA are the inspection authorities for imported
registered drugs. Drugs must be imported through port cities
where port-of-entry drug laboratories are located. These
laboratories would not inspect drugs imported via other
ports of entry.
Application procedures: After the imported drugs have
arrived at the port of entry, the importing enterprise has
to complete the Imported Drug Inspection Form and
submit it to the local port-of-entry drug laboratory
together with the Imported Drug Registration Certificate
(original or copy) and other relevant documents. After
inspection, the port-of-entry drug laboratory will prepare
an Imported Drug Inspection Report and issue an
Imported Drug Customs Clearance Note if the drugs are
up to standard. A negative report will be prepared if the
drugs do not meet requirements.
Re-inspection and arbitration: The importing enterprise may
apply to the original port-of-entry drug laboratory for
re-inspection within 30 days of receiving the inspection
report if it objects to the results of inspection. If it
still objects to the results of the re-inspection, it may
apply to the National Institute for the Control of
Pharmaceutical and Biological Products for arbitration
within 30 days of receiving the results of re-inspection.
(b) Supervision and Inspection of Exported Drugs
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Supervision of drug production
Production licence: Drug manufacturers in China must be
approved and issued a drug production licence by the local
provincial-level drug administration, and must register with
SAIC by presenting the drug production licence.
Quality certification: Drug manufacturers must undertake
production in accordance with the Quality Control
Standards for Drug Production formulated by SDA. SDA is
responsible for certifying whether or not an enterprise
complies with these standards and will issue a certificate
to those that are qualified.
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Export inspection
Enterprises may request a drug laboratory established by the
Ministry of Health to prepare a report on the inspection of
drugs for export. The criteria of inspection are generally
in accordance with the export contract.
3.2.6 Import Control on GM Agricultural Bioproducts
(a) Definition
Genetically modified (GM) agricultural bioproducts refer to plants,
animals, microbes and associated products genetically modified
through genetic engineering techniques for the purpose of
agricultural production or agricultural produce processing. Import
control on GM agricultural bioproducts varies according to their
usage, i.e. whether they are for research and experiment,
production, or processing as raw materials. GM agricultural
bioproducts include the following:
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GM animals and plants (including seeds, stud stocks, and
aquatic fries) and microbes;
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Products of GM animals, plants and microbes;
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Products directly processed from GM agricultural products;
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Seeds, stud stocks, aquatic fries, pesticides, vet
medicines, fertilisers and additives containing the elements
of GM animals, plants, microbes or associated products.
(b) Safety Rating
GM agricultural bioproducts are classified into the following four
categories according to their risks to mankind, animals and plants,
microbes, and the ecological environment:
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Safety Rating I: no existing risk
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Safety Rating II: low risk
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Safety Rating III: medium risk
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Safety Rating IV: high risk
(c) Labelling
China adopts a labelling system for the management of GM
agricultural bioproducts and publishes a catalogue accordingly. All
GM bioproducts listed in the catalogue must be properly labelled if
they are to be sold in the China market. Those not labelled or not
labelled according to requirements may not be imported or sold.
The following is the first batch of GM agricultural bioproducts
subject to labelling management.
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Soy bean seeds, soy bean, soy bean powder, soy bean oil and
bean dregs
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Corn seeds, corn, corn oil, corn powder (including corn
powder under tariff numbers 11022000, 11031300 and 11042300)
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Seeds of rape, rapeseed, rapeseed oil and rapeseed dregs
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Cotton seeds
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Tomato seeds, fresh tomatoes and tomato paste
(d) Entry Inspection
For the import of GM agricultural bioproducts, it is necessary to
apply to the Office for Safety Management of Genetically Modified
Agricultural Bioproducts for a safety certificate and import
approval by submitting the relevant documents. The types of
documents to be submitted depend on the usage of the GM agricultural
bioproducts, namely whether they are for research and experiment,
production, or processing as raw materials. Imports not accompanied
by the relevant approval documents or safety certificate, or imports
not compliant with the descriptions in the approval documents or
safety certificate, will be returned or destroyed.
Inspection and quarantine authorities will carry out entry
inspection against the approval documents and issue a clearance note
upon satisfactory inspection and quarantine, to be presented to
customs for clearance.