Administrative measures of inspection, quarantine and supervision on entry and exit aquatic products
AQSIQ Decree 135
Administrative Measures of Inspection, Quarantine and Supervision on Entry and Exit Aquatic Products has been reviewed and discussed at AQSIQ general meeting on 10 March 2010, and it is now passed for promulgation. The Measures will take effect from 1 June 2011. ( Minister, 4 January, 2011)
Chapter 1 General Rule - entry and exit aquatic products
Article 1 In order to strengthen the inspection and quarantine of entry and exit aquatic products and the supervision and administration thereof, to guarantee the quality safety and sanitation of entry and exit aquatic products, prevent the transfer of animal disease into/out of China, and to protect the safety of aqua farm production and human health, these Regulations are formulated in accordance with the Law of the People's Republic of China on Import and Export Commodity Inspection and the implementation regulations thereof, the Law of the People's Republic of China on Import and Export Animal and Plant Quarantine and the implementation regulations thereof, the Law of the People's Republic of China on Frontier Sanitation Quarantine and the implementation regulations thereof, the Food Safety Law of the People's Republic of China, the Special Regulations of the State Council for Strengthening Supervision and Management of Safety of Food and other Products, and other relevant laws and regulations.
Article 2 These Measures shall apply to the inspection and quarantine of entry and exit aquatic products and the supervision and administration thereof.
Article 3 Aquatic products as used in these Measures shall refer to the aquatic animals and the products thereof for human consumption, including the aquatic animals like scyphozoa, molluse, crustacean, echinodermata, cephalo chordata, fish, amphibian, reptile, aquatic mammal, other aquatic animals, and aquatic plants like alga, etc. and the products thereof (excluding live aquatic animals and the propagation materials thereof, hereinafter the same).
Article 4 The General Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as AQSIQ) shall administer the entry & exit inspection and quarantine, and the supervision and administration thereof of the whole country in a uniform way. The entry & exit inspection and quarantine bodies set up by the AQSIQ at the localities ( hereinafter referred to as the inspection and quarantine bodies) shall be in charge of the inspection and quarantine of entry and exit aquatic products and the supervision and administration thereof within the areas under their respective jurisdictions.
Article 5 In accordance with laws, the inspection and quarantine bodies shall conduct inspection, quarantine, supervision and random inspection of the entry and exit aquatic products, and conduct credit management and category management system on enterprises that manufacture and process entry and exit aquatic products (hereinafter referred to as manufacturing enterprises).
Article 6 Manufacturing enterprises shall conduct manufacture in accordance with laws, administrative regulations and relevant standards, bears responsibilities for society and the public, ensures quality and safety of aquatic products, accepts social supervision, and undertakes social responsibility.
Article 7 AQSIQ adopts registration management for issuers of certifications for entry and exit aquatic products, the personnel who are not registered with AQISQ cannot issue inspection and quarantine certificates.
Chapter 2 Import Inspection and Quarantine - aquatic products
Article 8 Imported aquatic products shall comply with Chinese laws, administrative regulations, national standard requirements of food safety; inspection and quarantine requirements in the agreements, protocols and MoUs signed between China and exporting countries or regions and quarantine requirements in commercial arrangements.
With regard to aquatic products that do not have any national standard for food safety, the consignee shall present the inspection and quarantine bodies with the permit issued by the health administrative departments of the State Council.
Article 9 In accordance with Chinese laws, administrative regulations, national standard requirements of food safety, risk analysis results of domestic and foreign aquatic disease and epidemic situation and pest, AQSIQ shall take into consideration the assessment of efficiency of quality and safety management system of the countries/regions planning to export aquatic products to China, formulate and publish the inspection and quarantine requirements of China for entry aquatic products; or sign inspection and quarantine agreements clarifying inspection and quarantine requirements and relevant certification requirements with countries or regions planning to export aquatic products to China
Article 10 AQSIQ adopts record management for the exporters or agents exporting aquatic products to China, and regularly publishes the list of those foreign exporters and agents that are qualified and registered.
Registration management of foreign manufacturing enterprises is implemented in accordance with relevant regulations of AQSIQ.
Article 11 Inspection and quarantine bodies shall put consignees of imported aquatic products into record management. Only the consignees already subject to record management are permitted to go through import process.
Article 12 Consignees of entry aquatic products shall establish aquatic entry and sale record system. The record shall be true, and be kept for no less than two years.
Article 13 With regard to entry amphibians, reptiles and aquatic mammals and other aquatic products of high risk, AQSIQ will implement quarantine approval system. The consignee of the above mentioned products must go through inspection approval procedure to get entry animal and plant quarantine permit before signing a commercial contract.
According to necessity and relevant regulations, AQSIQ will send officials to exporting countries or regions to conduct pre-clearance on aquatic products.
Article 14 Prior to or during entry of aquatic products, the consignee or the agent shall obtain original inspection quarantine certificate, certificate for country of origin, trade contract, bill of lading, packing sheet, invoice and other documents etc issued by the exporting country or region and apply to the inspection and quarantine bodies at the entry ports for inspection.
The inspection and quarantine certificate issued by the exporting country or region shall comply with the certification requirements of AQSIQ.
Article 15 Inspection and quarantine bodies shall examine the documents submitted by the consignee or the agent, accept the application for inspection if they can meet requirements, write off quarantine approvals, and issue the clearance certificate for entry goods.
Article 16 The entry aquatic products shall be stored in the cold store designated by the inspection and quarantine bodes. The entry ports shall possess suitable capacity for the quantity of entry aquatic products. The cold store shall comply with the inspection and quarantine requirements of cold store for entry aquatic products.
Article 17 Transport vehicles and containers loading and transporting entry aquatic products shall implement disease prevention and disinfection treatment under the supervision of inspection and quarantine bodies at the entry port. Without permission from inspection and quarantine bodies, entry aquatic products cannot be unloaded from transport vehicles and containers.
Article 18 The inspection and quarantine bodies at the entry port shall conduct on-site inspection and quarantine for entry aquatic products. The items subject to on-site inspection and quarantine includes the following:
(1). Verify the document and examine the goods;
(2). Check the package to see if the entry aquatic products meet the basic packaging requirements.
(3). Conduct phytosanitary quarantine, or when necessary, disinfestation treatment on entry brined or dried aquatic products that are easy to breed phytosanitary pests.
(4). Check whether the goods are rotten, dried, or with foreign matter or iced blood, or with too much ice or frost.
Article 19 The label of entry pre-packaged aquatic products in Chinese shall comply with mandatory requirements of relevant laws, administrative regulations in China, and technical standards of other countries. Inspection and quarantine bodies shall inspect the label of pre-packaged aquatic products in accordance with regulations.
Article 20 In accordance with regulations, the inspection and quarantine bodies shall collect samples of entry aquatic products, and carry out test or monitor the following items on basis of requirements of relevant standards, monitoring plans and warning notifications etc.:
(1). pathogenic microbes, residues of heavy metals, agricultural chemicals, veterinary drugs and other poisons or harmful matters;
(2). Epidemic diseases and parasites;
(3). Other required items.
Article 21 For the aquatic product that has passed inspection and quarantine, the inspection and quarantine bodies at entry port shall issue the inspection and quarantine certificate for entry goods, which approves the manufacture, processing, sale and use. The inspection and quarantine certificate for entry goods shall specify the traceable information including container number, manufacture batch number, manufacturer, and shipping mark etc.
With regard to the aquatic product that has not passed inspection and quarantine, the inspection and quarantine bodies shall issue a notification of inspection and quarantine treatment. If it is concerning the items other than human safety, health and environmental protection, it may be subject to technical treatment under the supervision of the inspection and quarantine bodies, and may be sold or used after being cleared through inspection and quarantine again.
For the applicant who applies for the certificate concerning the claim for compensation or other certificates, the inspection and quarantine bodies shall issue relevant certificates.
Article 22 The aquatic shall be returned or destroyed in any one of the following cases:
(1). The product, required to apply for entry quarantine approval, does not have a valid entry animal and plant quarantine permit;
(2). The establishment, required to be registered in China, is not registered;
(3). Does not have a valid inspection and quarantine certificate issued by official bodies of the exporting country or region;
(4). Does not meet requirements of human safety, health and environment protection items.
Chapter 3 Exit inspection & Quarantine - aquatic products
Article 23 The aquatic products for export shall be supervised and spot checked by the inspection & quarantine agency, and then the Customs could allow the aquatic products to pass as per the Customs Clearance Certificate issued hereby.
Article 24 The inspection & quarantine agency shall carry out the inspection & quarantine on the aquatic products and package thereof in accordance with the requirements as below:
(1). Requirements for inspection and quarantine in the importing country or region;
(2). Requirements for inspection and quarantine as specified by the inspection & quarantine-related agreement, protocol and memorandum signed by and between importing county or region and China;
(3). Requirements for inspection and quarantine as specified by Chinese laws & regulations and AQSIQ;
(4). Requirements for quality, quantity, weight and packing as officially specified by the importing country or region;
(5). Quarantine requirements as specified in the commercial contract.
Article 25 The inspection & quarantine bodies shall carry out registration on the aqua farm for export. The producers of aquatic products for export shall source the raw materials from the registered aqua farms, harvesting areas or fishing vessel approved by the fisheries administrative department and meet the inspection and quarantine requirements of the importing country or region.
Article 26 The registered aquatic farms shall meet the basic conditions and sanitary requirements as below:
(I). Obtain cultivating permission from the fisheries administrative department;
(II). Certain scale of farming: total area of pond or open maritime space for farming shall be over 50 mu; total area of cement pool for farming shall be over 10 mu. Also, the standardized no. for the rearing pond shall be available;
(III). Sufficient water source; the water for aqua farm farming is subject to the Water Quality Standard for Aqua farm;
(IV). Free from livestock & poultry farm, hospital, chemical factory, dump; also, facilities are available to separate the outside environment; the sanitary environment inside the aqua farm is good;
(V). Properly arranged to meet the quarantine as required, so as to avoid the cross contamination arising from water supply or drainage;
(VI). The warehouse for medicines and warehouse for forage are respectively established; also, these warehouses shall be kept clean, dry and ventilated. The registrant shall be available to record the warehousing and delivery;
(VII). Cultivating density is appropriate; also, the equipment for oxygen increase shall fit for the cultivating density;
(VIII). The forage is from the forage processing factory archived by the inspection & quarantine agency as well as subject to the Measures for Inspection and Quarantine on Forage of Edible Animal as specified;
(IX). Do not use the drug and other poisonous substances forbidden by China, importing country or region. The adopted drug shall be marked with effective ingredients and records for use as well as strictly follow the drug withdrawal as required;
(X). Perfect management agency and written aqua farm farming control system (including young fish procurement, cultivating, quarantine and use of drug & forage);
(XI). The qualified aqua farm technician and quality supervisor shall be available; also, the qualified aqua farm technician and quality supervisor shall be assumed by different person. The aqua farm technician shall use the medicine according to the formula, while the medicine shall be issued by the quality supervisor. Both the qualified aqua farm technician and quality supervisor shall meet the conditions as follows:
- Familiar with and follow the inspection & quarantine-related laws, administrative regulations;
- Familiar with and follow regulations for aquatic disease and veterinary medicine as specified by the administrative department for agriculture;
- Familiar with regulations and standards for chemical residual control as specified by the importing country or region;
- Provided with certain cultivating experience or above the degree for cultivating.
(XII). Establishing of timely report system for major epidemic diseases and incidents
Article 27 Registration of aqua farm for exported aquatic products shall follow the procedures as below:
(I). Aqua farm for exporting aquatic products shall apply for registration and submit relevant documents to the local inspection & quarantine agency;
(II). As per the basic conditions and sanitary requirements in article 26 herein, the inspection & quarantine agency shall examine the candidate aqua farm for exporting aquatic products. The inspection and quarantine agencies can approve and grant registration certificate to the qualified aqua farms which meet the above basic conditions and sanitary requirements;
(III). The registration certificate shall come into force since the date when it is issued. The effective period thereof lasts for four years. The renewal thereof shall be proposed by the aqua farm for exporting aquatic products three months ahead of the expiry of the effective period;
(IV). In case of change of address, name, cultivating scale, ownership and legal representative, the registered aqua farms for exported aquatic products shall timely re-apply for registration or handle the procedures for change at the local inspection & quarantine agency.
Article 28 The aqua farm for exporting aquatic products shall provide each batch of raw materials for exported aquatic products with supply certification.
Article 29 The agricultural inputs such as forage and veterinary medicine shall be used by the archived aqua farm for exported aquatic products in accordance with the food safety standards and regulations as specified by the importing country or region or China. Do not purchase or use the agricultural inputs which are not subject to the food safety standards and regulations as specified by the importing country or region or China.
Article 30 The inspection & quarantine agency shall inspect and supervise the archived aqua farm for exported aquatic products as well as conduct relevant records. The inspection & supervision shall include daily inspection and annual examining.
Based on the risk analysis, the inspection & quarantine agency shall carry out the monitoring on aquatic diseases, veterinary medicine residual, pollutant, water quality and other poisonous substances for the archived aqua farm for exported aquatic products, so as to set up the perfect safety risk information control system for exported aquatic products.
Article 31 The manufacturers for exported aquatic products shall be archived by the inspection & quarantine agency according to the regulations for archiving management of food manufacturers.
If requirements for registration is raised by the importing country or region for China’s manufacturers for exported aquatic products and the registered enterprises are recommended, AQSIQ’s relevant regulations shall be followed.
Article 32 The manufacturers for exported aquatic products shall set up the perfect quality safety control system, which is traceable, so as to guarantee that the fresh-keeping agent, antiseptic, water-keeping agent and color-keeping agent are not improperly used in the aquatic products.
The manufacturers for exported aquatic products shall carry out the self-inspection on such poisonous substances as microbe, insecticides & veterinary medicine residual and pollutant on the raw materials and finished products. If the self-inspection is unavailable, the qualified inspection & testing agency shall be entrusted to conduct the inspection.
Article 33 As the aquatic products are processed, the production batch control shall be carried out by the manufacturers for exported aquatic products on the basis of aqua farm. For the aquatic products from different fisheries, the raw materials thereof shall not be processed as the same production batch. From raw materials to finished products, the production batch no. shall be kept unchanged.
The marking of production batch no. shall be separately specified.
Article 34 The manufacturers for exported aquatic products shall set up the examining records for raw material procurement and examine the attached supply certificate for the raw materials. The records for supply examining shall be authentic and kept for at least two years.
The manufacturers for exported aquatic products shall set up the ex-work examining system to examine the qualification and safety conditions of the ex-work aquatic products as well as truly record the name, specification, quantity, production date, production batch no., qualification no., purchaser name & liaison and selling date of the aquatic products.
Examining records for ex-work aquatic products shall be authentic and kept for at least two years.
Article 35 The packing label for the exported aquatic products shall be subject to the requirements as specified by the importing country or region. The importing country or region shall be clearly marked on the package for delivery.
Article 36 As specified by AQSIQ, the manufacturers for exported aquatic products or the agents thereof shall ask the local inspection & quarantine agency to carry out the inspection on the strength of trading contract, manufacturer’s test report or ex-work qualification and delivery note.
As the exported aquatic products are delivered for inspection, the written certificate shall be available to verify the content of poisonous substances such as drug residual, heavy metal and microbe meet the requirements as specified by the importing country or region and China.
Article 37 Based on the risk analysis, the pathogenic microbe, insecticides & veterinary medicine residual and pollutant in the exported aquatic products shall be sampled by the inspection & quarantine agency; also, examining and supervision shall be conducted for the quality safety control system during the production & processing of exported aquatic products.
Article 38 For the exported aquatic products without sampling, the inspection & quarantine agency shall examine the test report and shipment records thereof as required by the importing country or region, so as to carry out the comprehensive appraisal according to the daily supervision, monitoring and sampling. The relevant inspection & quarantine certificate could be issued for meeting the requirements, or the notice for disqualification shall be issued.
Article 39 The manufacturers for exported aquatic products shall ensure that the transpiration tools for exported aquatic products are provided with good sealing performance, so as to keep the aquatic products from pollution; also, the temperature demanded for transportation shall be guaranteed. In addition, sterilization shall be carried out as specified and relevant records shall be available.
Article 40 The manufacturers for exported aquatic products shall ensure that the goods are in conformity with the certificate and relevant records for delivery shall be available. The spot check shall be conducted by the inspection & quarantine agency. For the exported aquatic products passing the inspection at local area, they shall not be allowed to pass if the inconformity thereof to the certificate is found by the inspection & quarantine at the port.
Article 41 The effective period for inspection & quarantine of exported aquatic products shall be
(I). Frozen (fresh-keeping) products: seven days;
(II). Frozen dry products and independently frozen products: four months;
(III). Other aquatic products: six months.
The exported aquatic products shall be re-inspected in case of exceeding the effective period of inspection and quarantine. Also, the inspection and quarantine of exported aquatic products shall be separately conducted if required particularly by the importing country or region.
Chapter 4 Supervision & Management - entry and exit aquatic products
Article 42 AQSIQ shall carry out safety monitoring system for entry and exit aquatic products, formulate monitoring plans on basis of risk analysis, and real situation of inspection and quarantine, and identify the types and inspection items of entry and exit aquatic products from the country or region to be monitored.
In accordance with annual safety risk monitoring plans by AQSIQ for entry and exit aquatic products, inspection and quarantine bodies shall formulate and implement the implementation scheme of risk management for entry and exit aquatic products in their jurisdiction areas.
Article 43 AQSIQ and inspection & quarantine agencies shall carry out the risk management on entry and exit of aquatic products. The specific measures thereof shall be subject to the relevant regulations.
Article 44 The manufacturer, consignee and consignor of aquatic products for entry & exit shall carry out the production and operation legally.
The inspection & quarantine agency shall set up illegal behavior archiving system for the manufacturer, consignee and consignor of aquatic products for entry & exit, so as to archive and disclose the illegal behavior.
Article 45 In accordance with relevant regulations of food safety risk information management, AQSIQ and the inspection and quarantine bodies shall notify relevant departments, bodies and enterprises of safety risk information concerning entry and exit aquatic products, and in accordance with relevant regulations, submit reports.
Article 46 The coordination system shall be enhanced between the inspection & quarantine agency governing the archived aqua farm for exported aquatic products and that governing the manufacturer for exported aquatic products. The monitoring on aqua farm shall be regularly informed by the inspection & quarantine agency governing the archived aqua farm for exported aquatic products to that governing the manufacturer for exported aquatic products; the manufacturer’s examining on supply certification as well as quality safety of raw materials and finished products shall be regularly informed by the inspection & quarantine agency governing the manufacturer for exported aquatic products to that governing the archived aqua farm for exported aquatic products.
Article 47 In case the imported aquatic products have safety problems, which may or have caused the injury on the human body and life, the consignee shall actively recall such aquatic products and immediately report such safety problems to the local inspection & quarantine agency. If the consignee fails to make the above recall, the inspection & quarantine agency shall order the consignee to recall the aquatic products with such safety problems.
In case the exported aquatic products suffer from safety problems, which may or have caused the injury on the human body and life, the manufacturer for exported aquatic products shall actively recall such aquatic products and immediately report such safety problems to the local inspection & quarantine agency.
In case of recalling of aquatic products for entry and exit, it shall be timely reported by the inspection & quarantine agency to AQSIQ.
Article 48 The registered aqua farms for exported aquatic products shall be cancelled from qualification in case of the situations as below:
(I). Use or storage of drug and other poisonous substances forbidden by China and importing country or region; the adopted drug is not marked with the effective ingredient or use of the drug with forbidden medicine and medicine additive; the drug is not suspended as specified during the drug suspension period;
(II). Provision of fake supply certificate, transfer or transfer in disguised form of archiving no.;
(III). Concealing of major epidemic disease of aquatic products or failing to report such epidemic disease to the inspection & quarantine agency;
(IV). Refuse the management and monitoring from the inspection & quarantine agency;
(V). Fail to apply for the modification within 30 days after the name and legal representative of archived aqua farm are changed;
(VI). Fail to report the inspection & quarantine agency within 30 days after the size of aqua farm is enlarged; new drug or forage is adopted or quality safety system is substantially changed;
(VII). The goods are not exported within a year;
(VIII). The renewal of achieving is not applied as scheduled;
(IX). Fail to pass the annual examining.
Article 49 The inspection & quarantine agency could order the manufacturer of exporting aqua products to take corrective measures in case of one of the situations as below:
(I). The products are rejected by the importing country or region for the first time due to the disqualification in safety & health-related items such as pathogenic microbe, pollutant, insecticide & veterinary medicine;
(II). The consecutive sampling of three batches of products fails to meet the requirements for safety & health;
(III). The source of raw materials is unknown; batch no. control is disordered;
(IV). During the daily inspection, the same disqualified item is found for three times within a year;
(V). Fail to establish the product feedback and recall system.
Article 50 In case the manufacturers for importing & exporting aquatic products have other violations against the laws, they shall be punished as per the relevant laws & administrative regulations.
Article 51 If the inspection & quarantine agency and personnel thereof violate laws & regulations and the measures as carrying out the inspection & quarantine on the imported & exported aquatic products, they shall be punished by the competent department at higher level.
Chapter 5 Supplementary Articles - entry and exit aquatic products
Article 52 The Measures are subject to interpretation by AQSIQ.
Article 53 The Measures will come into effect on 1 June 2011. Also, the Regulations on Inspection and Quarantine of Imported and Exported Aquatic Products (AQSIQ Order No. 31) published on 6 November, 2002, shall be abolished simultaneously.
