18 March 2015
Entry-exit Inspection for Different Categories of Commodities
Hygiene Supervision and Inspection of Food
(a) Inspection of Import Food
Under Article 62 of the Food Safety Law of the People’s Republic of China which came into force on 1 June 2009, all import food, food additives and food-related products should meet the food safety standards of China. Import food should pass the examination of the entry-exit inspection and quarantine authorities which will issue a clearance certificate for customs clearance.
Under Article 63 of the Food Safety Law, importers of food not covered by any national food safety standards, new types of food additives imported for the first time, or new types of food-related products should submit an application for import with related safety appraisal documents to the health administrative department of the State Council, which will decide if permission for import should be granted under Article 44 of the Food Safety Law, and will draw up corresponding national food safety standards in a timely manner.
(b) Inspection of Export Food
Under Article 68 of the Food Safety Law, all food exports are subject to supervision and sample testing by entry-exit inspection and quarantine authorities which will issue a clearance certificate for customs clearance. According to Article 4 of the Administrative Measures on Import and Export Food Safety which came into force on 1 March 2012, operators engaged in the planting and breeding of raw materials of exported food are required to file a record with AQSIQ which is responsible for the supervision and sample testing of export food.
(c) Registration of overseas producers of import food
Under Article 65 of the Food Safety Law, overseas producers of food for export to China should complete a registration process with China’s entry-exit inspection and quarantine authorities.
In accordance with the Administrative Regulations on Registration of Overseas Producers of Import food which came into force on 1 May 2012, AQSIQ has drawn up, revised and promulgated the Catalogue for the Registration of Overseas Producers of Import Food. The import food mainly refers to meat, aquatic products and dairy products. Overseas enterprises engaged in the production, processing and storage of food covered by the Catalogue should complete the registration process before their products can be imported into China. Overseas food producers can file an application with AQSIQ through their local food hygiene authorities. Enterprises meeting all the requirements will be registered and included in the List of Countries and Enterprises Approved for Exporting to China with a specific registration number issued by AQSIQ.
(d) Registration of overseas exporters or agents of import food
Under Article 65 of the Food Safety Law, overseas exporters and agents of food for export to China should file a record with the entry-exit inspection and quarantine authorities.
(e) Export food producer filing system
According to the Regulations on Filing Administration of Export Food Producers which came into force on 1 October 2011, the export food producer filing system that came into operation on 1 October 2011 is applicable to all enterprises engaged in the production of export food within the territory of China. These enterprises should set up and ensure the effective implementation of a food safety and hygiene control system. The system should focus on risk analysis and preventive control measures with a view to ensuring that the production, processing and storage processes of export food are always in compliance with the related statutory requirements of China, the legal requirements of the importing country (or region), and the safety and hygiene requirements for export food producers. In making the filing application, the export food producers should provide all the related food production licences and other administrative permits as appropriate. The local entry-exit inspection and quarantine authorities under AQSIQ are responsible for the filing, supervision and inspection of the export food producers within their jurisdiction, and for the issue of the Export Food Producer Filing Certificate to producers complying with all the filing requirements.
Supervision and Inspection of Mechanical and Electrical Products
(a) Scope of Mechanical and Electrical Products
The Statistical Handbook on the Import and Export of Mechanical and Electrical Products (1999 Edition) compiled by the Department for Import and Export of Mechanical and Electrical Products under the former Ministry of Foreign Trade and Economic Cooperation includes a Catalogue of Mechanical and Electrical Products, which AQSIQ uses as the basis for defining the scope of mechanical and electrical products subject to entry-exit inspection and supervision. According to the Administrative Measures for the Importation of Mechanical & Electrical Products jointly promulgated by the Ministry of Commerce, General Administration of Customs and AQSIQ in 2008, mechanical and electrical products refer to all mechanical equipment, electrical equipment, means of transportation, electronic products, electrical apparatus, instruments and meters, and metal products as well as their parts and components.
(b) Regulations for Inspection of Import Mechanical and Electrical Products
On 1 May 2003, the China Compulsory Certification (CCC) mark was implemented. Products which have not been issued the compulsory certification certificate and do not carry the CCC mark are not allowed to be imported into or sold in China.
Importation requirements for used mechanical and electrical products: A system of filing for the record is adopted for used mechanical and electrical products allowed to be imported. Used mechanical and electrical import products not meeting the relevant requirements will not be filed. For the import of used mechanical and electrical products involving safety, hygiene and environmental protection concerns, pre-shipment inspection and inspection upon goods arrival are required where the result of the inspection upon arrival prevails. As for other used mechanical and electrical 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 Used Mechanical and Electrical Import 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 Used Mechanical and Electrical Import Products (“the Exemption Certificate”). Upon arrival of the used mechanical and electrical products at the port, the consignee or its agent should present the Exemption Certificate (original) or the Record (original), or the Pre-Shipment Inspection Report (original), Pre-Shipment Inspection Certificate (original) and other necessary documents for application for entry inspection. After the entry-exit inspection and quarantine authorities at the port of entry have accepted the application for inspection, 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 electrical products.
Importation requirements for complete sets of equipment: Import commodities or major complete sets of equipment that involve national interest or people’s livelihood, higher value, sophisticated technology and other major concerns and covered by the statutory inspection scope should be subject to production supervision, pre-shipment inspection or packaging supervision in accordance with the provisions of the relevant foreign trade contracts.
Supervision and Inspection of Drugs
The China Food and Drug Administration (CFDA) is responsible for the supervision and inspection of drugs.
(a) Supervision and Inspection of Import drugs
Registration of import drugs
China implements a registration and approval system for import drugs. Under the Measures for Administration of Drug Registration which came into force on 1 October 2007, all import drugs must obtain an Import Drug Registration Certificate from CFDA. Manufacturers of Hong Kong, Macau and Taiwan must obtain a Pharmaceutical Product Registration Certificate for their drugs applying for registration. The import drug production plants must meet the drug production and quality control standards of the producing country as well as the requirements of China’s Good Manufacturing Practice (GMP). Drugs applying for import into China must be granted approval for public sale by the local authorities of the producing country or region, unless the drug is confirmed by CFDA to be safe and effective, and meet clinical needs. Drugs applying for import into China must comply with the GMP drug production requirements of both the producing country or region and China.
The China office or registered agent of the foreign drug manufacturer is responsible for applying for import drug registration. They have to submit the Import Drug Registration Certificate Application Form together with other required documents to CFDA for examination and approval. These offices or agents must be legitimate establishments registered with China’s industry and commerce administration authorities.
After reviewing the quality of the drug and organising the necessary clinical studies, CFDA will grant an Import Drug Registration Certificate to the import drugs in question. This certificate is the official approval document for the registration, import, sale and use of foreign drugs in China.
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 labelling must be reported to CFDA.
Application for inspection
Inspection organs: The port-of-entry drug laboratories set up by CFDA are the inspection authorities for registered import 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 import drugs have arrived at the port of entry, the importing enterprise has to complete the Import Drug Inspection Form and submit it to the local port-of-entry drug administration together with the Import Drug Registration Certificate or Pharmaceutical Product Registration Certificate (original or copy), (and an additional Import Permit for the import of narcotics and psychotropic drug) as well as other related documents. After verifying all the documents, the port-of-entry drug administration will issue a Port-of-entry Inspection Notice for Import Drug to the local port-of-entry drug laboratory. After inspection, the laboratory will submit a report to the local port-of-entry drug administration. Drugs meeting the requirements will be issued an Import Drug Clearance Slip by the port-of-entry drug administration while those not meeting the requirements will be issued a Filing Notice of Drug Import Rejection.
Re-inspection and arbitration: The importing enterprise may apply to the original port-of-entry drug laboratory or the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP) for re-inspection within 7 days upon receipt of the inspection report if it objects to the results of inspection. Application for re-inspection of biological products should be made directly with NICPBP.
(b) Supervision and Inspection of Export Drugs
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 the industry and commerce administration department 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 the drug administration authority under the State Council. The competent drug administration authority is responsible for certifying whether or not an enterprise complies with these standards and will issue a certificate to those qualified.
Enterprises may request a drug laboratory established by the health department to prepare a report on the inspection of drugs for export. The criteria of inspection are generally in accordance with the export contract.
Import Control on GM Agricultural Bioproducts
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:
GM animals and plants (including seeds, stud stocks, and aquatic fries) and microbes;
Products of GM animals, plants and microbes;
Products directly processed from GM agricultural products; and
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:
Safety Rating I: no existing risk
Safety Rating II: low risk
Safety Rating III: medium risk
Safety Rating IV: high risk
China adopts a labelling system for the management of GM agricultural bioproducts and publishes a catalogue accordingly. All GM agricultural 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.
Soy bean seeds, soy bean, soy bean powder, soy bean oil and bean dregs
Corn seeds, corn, corn oil, corn powder (including corn powder under tariff numbers 11022000, 11031300 and 11042300)
Seeds of rape, rapeseed, rapeseed oil and rapeseed dregs
Tomato seeds, fresh tomatoes and tomato paste
(d) Entry Inspection
According to the Measures for Safety Management of Genetically Modified Agricultural Bioproducts, the import of GM agricultural bioproducts requires an application to be made to the Office for Safety Management of Genetically Modified Agricultural Bioproducts or Ministry of Agriculture 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 an Import Goods Clearance Slip upon satisfactory inspection and quarantine for customs clearance.