28 Sept 2018
Entry-exit Inspection for Different Categories of Commodities
Hygiene Supervision and Inspection of Food
(a) Inspection of Import Food
Under Article 92 of the Food Safety Law of the People’s Republic of China which came into force on 1 October 2015 (Food Safety Law), all import food, food additives and food-related products should meet the food safety standards of China. Import food and food additives should pass the inspection conducted in accordance with the provisions of existing laws and administrative regulations related to the inspection of import-export commodities. Proofs of passing the inspection should be produced for the import of food and food additives as required.
Under Article 93 of the Food Safety Law, overseas exporters and producers or their appointed importers of food not covered by any national food safety standards and new types of food additives or food-related products to be imported into China for the first time should submit an application for import with related safety appraisal documents to the health administration department of the State Council, which will decide if permission for import should be granted under Article 36 of the Food Safety Law, and will draw up corresponding national food safety standards in a timely manner.
Import of food items made of new food ingredients and import of new types of food additives or food-related products should follow the requirements specified in Article 37 of the Food Safety Law.
Under Article 94 of the Food Safety Law, overseas exporters and producers should ensure that the food, food additives and food-related products exported to China comply with the provisions of the Food Safety Law and other related laws and regulations of China, and meet the requirements of its national food safety standards. They should also be held responsible for the contents of the labels and product descriptions. Importers should set up a verification system for overseas exporters and producers with regard to their compliance with the key elements of the above requirements. Import is not allowed for those failing the compliance verification. If non-compliance of China’s national food safety standards is found in the import food or if there are proofs that these food products may be hazardous to human health, the importers should immediately cease such imports and recall the products concerned in accordance with Article 61 of the Food Safety Law.
Under Article 97 of the Food Safety Law 2015, all pre-packaged food products and food additives to be imported into China should have Chinese labels. For those required to provide product descriptions under the law, a Chinese version should be included. All labels and product descriptions should comply with the provisions of the Food Safety Law and other related laws and administrative regulations of China, and meet the requirements of the national food safety standards. Information regarding the food’s origin and the name, address and contact details of the domestic agent should also be spelt out. Pre-packaged food products without Chinese labels or Chinese product descriptions or not complying with the label and product description requirements of this article are not allowed to be imported into China.
Under Article 76 of the Food Safety Law, health food products made of materials not listed in the Catalogue of Health Food Materials and those imported into China for the first time are required to be registered with the food and drug administration department of the State Council (food and drug department). Where first-time imports are nutritious food products such as vitamin supplements or minerals, a record should be filed with the food and drug department. Importers of other health food products should file a record with the local food and drug administration authorities of the respective provinces, autonomous regions and municipalities. Health food products imported into China must have been approved for sale by the competent authorities of the exporting country (or territory).
Under Article 80 of the Food Safety Law 2015, formula food products for special medical purposes should be registered with the food and drug department by producing their formula, production technique information, labels, product descriptions, and other documents asserting the food safety compliance and nutritional sufficiency of the products as well as the clinical effects of their special medical purposes. Advertising materials of formula food for special medical purposes should comply with the provisions of the Advertising Law of the People’s Republic of China as well as other laws and administrative regulations governing drug advertisements.
Under Article 81 of the Food Safety Law, the formula of milk powder for babies and toddlers should be registered with the food and drug department by producing the R&D report for the formula and other documents asserting the scientific and safety features of the formula.
Formula milk powder for babies and toddlers should not be produced in the form of split packaging. Different brands of formula milk powder for babies and toddlers must not be produced by the same enterprise using the same formula.
(b) Inspection of Export Food
Under Article 99 of the Food Safety Law, export food producers should ensure that the food produced by them for export meet the standards of the importing countries (regions) or the requirements of the contracts.
Export food producers and farm operators engaged in the planting and breeding of export food materials should file a record with the inspection and quarantine department.
(c) Record Filing of Overseas Exporters or Agents of Import Food and Registration of Overseas Producers of Import Food
Under Article 96 of the Food Safety Law, overseas exporters and agents of food for export to China as well as domestic food importers should file a record with the inspection and quarantine department, whereas overseas producers of food for export to China should also register with the department.
Under Article 101 of the Food Safety Law, importers should set up an import and sales record system for food and food additives to truthfully record their names, specifications, quantities, production dates, production or import lot numbers and expiry dates. The system should also keep a record of the names, addresses and contact information of the overseas exporters and buyers plus their delivery schedules, together with all the supporting documents. The retention period of the records and supporting documents should comply with the requirements of Article 49(2) of the Food Safety Law.
Under Article 93 of the Food Safety Law, the inspection and quarantine department may conduct appraisal and examination on the food safety administration systems and food safety conditions of the countries (or territories) exporting food products to China in order to ascertain the corresponding inspection and quarantine requirements based on the results of these appraisal and examination.
In accordance with the Administrative Regulations on Registration of Overseas Producers of Import food which came into force on 1 May 2012, CNCA is responsible for drawing up and revising the Catalogue for the Registration of Overseas Producers of Import Food (the Catalogue). The import food mainly refers to meat, aquatic products, edible bird’s nests 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 CNCA 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 CNCA.
(d) Record Filing of Export Food Producers
According to the Regulations on Filing Administration of Export Food Producers which came into force on 1 January 2018, the filing administration system of export food producers that came into operation on 1 January 2018 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 with food defense plans. 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 (territory), 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 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.
Inspection and Control 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. According to the Administrative Measures for the Importation of Mechanical & Electrical Products jointly promulgated by MOFCOM, GAC and AQSIQ in 2008, mechanical and electrical products refer to all mechanical equipment, electrical equipment, transport vehicles, 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: Used mechanical and electrical products allowed to be imported are subject to pre-shipment inspection, port-of-entry inspection, inspection upon arrival and supervision. 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. When the used mechanical and electrical products arrive at the port, the consignee or its agent should present the Pre-Shipment Inspection Certificate (original) or the Import Declaration of Used Mechanical and Electrical Products and other necessary documents for application for entry inspection. After the 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.
- 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.
Drug Inspection and Control
The state drug administration department is responsible for the inspection and control of drugs.
(a) Inspection and Control 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 the state drug administration department. 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 comply with the Good Manufacturing Practices (GMP) for pharmaceutical products of both the producing country and China. Drugs applying for import into China must be granted approval for sale by the local authorities of the producing country or territory, unless the drug is confirmed by the state drug administration department to be safe and effective, and meet clinical needs. Production of the drugs applying for import into China must comply with the GMP for pharmaceutical products of both the producing country or territory 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 completed Application Form for Import Drug Registration Certificate together with other required documents to the state drug administration department 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 concluding the necessary clinical studies, state drug administration department 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 or the form and content of labelling must be reported to state drug administration department for record purpose.
- Application for inspection
Inspection organs: The port-of-entry drug laboratories set up by state drug administration department 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 Application Form for Import Drug Inspection 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 the original 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 seven 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 GMP for Pharmaceutical Products formulated by the drug administration department under the State Council. The competent drug administration department is responsible for certifying whether or not the drug manufacturers comply with the GMP for Pharmaceutical Products and will issue a certificate to those qualified.
- Export inspection
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 generally follow the requirements spelt out in the export contract.
Import Control on Genetically Modified Agricultural Bioproducts
(a) 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 by their usage, i.e. whether they are for research and experiment, for production, or for 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 administration 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 administration.
- 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
- Cotton seeds
- Tomato seeds, fresh tomatoes and tomato paste
(d) Entry Quarantine
According to the Measures for Safety Management Governing the Import 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, for production, or for processing as raw materials. Imports not accompanied by the relevant approval documents and safety certificate, or imports not compliant with the descriptions in the approval documents and safety certificate, will be returned or destroyed.
Customs authorities carry out entry inspection and quarantine on the basis of the approval documents. An Import Goods Clearance Slip will be issued upon satisfactory inspection and quarantine for customs clearance and goods release.