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The supervision and management regulation of imported and exported dairy products of China

 

 Supervision and Administration  Measures of  Import and Export dairy Inspection and Quarantine

 

Chapter I General Principles

Article 1 In order to strengthen inspection and quarantine supervision and administration of import and export dairy products, formulate the Supervision and Administration  Measures of  Import and Export dairy Inspection and Quarantine (hereinafter referred to as " the Measures") in accordance with the provision of laws and regulations which are  "Food Safety Law of the People's Republic of China" (hereinafter referred to as the "Food Safety Law") and its implementing regulations, " Supervision and Management Regulations of Dairy Quality and Safety ", "Law of The People's Republic of China on Import and Export Com-Modity Inspection"and its implementing regulations,"Law of the People's Republic of China on the Entry and Exit Animal and Plant Quarantine" and its implementing regulations,"the Special Provisions of the State Council on Strengthening Supervision and Management of Food and Product Safety"(hereinafter referred to as "Special Provisions") and other laws and regulations.

Article 2  Dairy in this administration Measures refers to raw milk and dairy products.

Raw milk refers to the normal milk which is from the breast of the healthy dairy stock in accordance with Chinese relevant requirements, without any change in constituent. The colostrum generated after calving for seven days, the milk generated during antibiotic drugs using period and drug withdrawal period, and bad milk cannot be used as raw milk.

Dairy product refers to the food processed from milk (including raw milk, reconstituted milk or other liquid milk only after a sterilization procedure). Dairy products include but are not limited to the following product categories: pasteurized milk, sterilized milk, formulated milk, fermented milk, cheese and processed cheese, butter, condensed milk, milk powder, whey powder and milk-based infant formula food.Among them, the product processed from raw milk, without heat treatment sterilization process in its processing technic o is regarded as raw dairy product.

Article 3 State Administration for Quality Supervision and Inspection and Quarantine£¨hereinafter referred to as "AQSIQ") shall be responsible for the nationwide supervision and management on the safety of import and export of dairy.

All the Exit and Entry Inspection and Quarantine Authority located across the country by AQSIQ(hereinafter referred to as the "inspection and quarantine authority") are responsible for the inspection and quarantine supervision and management on the import and export dairy in the areas under their jurisdiction .

Article 4 The producers and operators of import and export dairy production and operation shall be honest and trustworthy, ensure food safety, be responsible for the society and the public, accept social supervision, and commitment to social responsibility.

 

Chapter II Dairy Importing

Article 5 In accordance with Chinese laws and regulations, national food safety standard, results of risk analysis of epidemic situation and epidemic disease both at home and abroad and toxic and harmful substances, AQSIQ works out relevant inspection and quarantine requirements on the basis of evaluation and examination.

Article 6 In accordance with Chinese laws and regulations, AQSIQ performs evaluation on food safety management system and food safety situations of the country (region) which exports dairy to China and carries out a retrospective examination under needs of imported dairy safety supervision management. 

AQSIQ shall evaluate the laws and regulations?ˉ system of veterinary hygiene and public hygiene, institutional framework, veterinary service system, safety and hygiene controlling system, residue monitoring system, detection and monitoring of animal epidemic disease provided by the competent department of the country£¨region£?that exports raw milk and raw milk products to China for the first time. If the risks are acceptable based on thereof evaluation, the exporting country (region) is allowed to export raw milk and raw milk products to China after the both parties enter into and conclude an Inspection and Quarantine Requirements Protocol.

As to the country £¨region£?exporting other dairy products other than raw milk products to China for the first time, AQSIQ shall evaluate the source of dairy products?ˉ raw materials, production and processing craft, ingredients and  use of additives and other information provided by the competent department of the exporting country(region), which shall be allowed to be exported to China after the risks are acceptable based on hereof evaluation.

Article 7 AQSIQ shall carry out a registration system for the oversea food production enterprises that export dairy to China while the registration shall be performed under relevant regulations set forth by AQSIQ.

The oversea production enterprise that export dairy shall be established through an official approval of the exporting country (region) and conform to relevant laws and regulations of the exporting country (region).

Article 8 The dairy exported to China shall be attached with the hygienic certificate issued by the official competent department of the exporting country£¨region£?. The certificate shall consist of the following items:

£¨1£?    raw material of dairy is from healthy animals;

£¨2£?the processed dairy shall not carry or spread animal epidemic diseases;

£¨3£?dairy production enterprises shall be under supervision of local official departments;

£¨4£?Dairy can be consumed by human beings based on results of inspection;

£¨5£?Dairy conforms to Chinese national food standards.

The certificate mentioned above shall be sealed by the certificate issue authority or signed by the authorized person while ?°the People?ˉs Republic of China?± shall be marked as the destination.

The sample certificate shall be confirmed by AQSIQ and published on the official website of AQSIQ.

Article 9 As to the imported dairy in need of going through an approval process of quarantine, they can be imported after gaining the Permit of the People Republic of China on Quarantine of Entry Animals and Plants

AQSIQ shall adjust and publish the dairy variety needing an approval process of quarantine as needed.

Article 10 The oversea exporters or agents engaged in exporting dairy to China shall be put on record in AQSIQ. The oversea exporters or agents that apply for being put on record shall provide the registering information under the requirements of registration and shall be responsible for the authenticity of the offered information. All the recorded information shall be published by AQSIQ.

Article 11 Inspection and Quarantine authorities shall carry out the recording management for the consignee of the imported dairy while the consignee shall apply for being put on record to the local Inspection and Quarantine authorities in advance and submit the following materials:

£¨1£?The well filled and prepared recording application form of the consignee;

£¨2£?Reproductions of Industry and Commerce Business License, Code Certificate of Organization, Identification Paper of Legal Representative, Registration Form of Foreign Trade Operator and their original copies shall be submitted for confirmation.  

£¨3£?Enterprise quality safety management system;

£¨4£?The planned dairy variety and storing locations;

£¨5£? As to an unit that carries out the application for inspection and quarantine, a copy of the registration certificate of the unit shall be submitted together with the original certificate for confirmation.

£¨6£?The enterprise that imports infants and young children formula food products and dairy or raw materials specially used for specific people group, shall provide the contact person and contact way of its dealer or domestic enterprise using its raw material;

£¨7£?The materials required by AQSIQ.

Article 12 The consignee of imported dairy or its authorized agent shall carry the following materials to the Inspection and Quarantine Authority for inspection and quarantine where the customs declaration office is located:

£¨1£?Contract, invoice, loading list, bill of lading and other necessary certificates;

£¨2£?relevant approval documents;

£¨3£?the hygienic certificate issued by the competent department of the imported country£¨region£?as laid down in Article 8 of the Measures;

£¨4£?as to the imported dairy in need of inspection and quarantine, examination and approval, submit the entry animal and plant quarantine permit certificate;

£¨5£?as to the dairy imported for the first time but without national food safety standard set for it, submit the documentary evidence of import licensing of the Ministry of Health;

£¨6£?as to the products with function of health care, certificate of licensing;

£¨7£?As to the infants and young children formula products and other dairy specially used for specific people group, submit an official certificate of permitting sale in the production country (region).

Article 13 The imported dairy shall conform to Chinese national food safety standards.

Sensory requirements, raw material and safety and hygiene indexes on the semi-finished products that are imported for manufacturing infants and young children formula products or the semi-finished products of dairy that are imported especially for other specific people group shall be subject to the national food safety standards corresponding to their processed products.

The dairy imported for the first time but without national food safety standard set for it shall comply with relevant requirements set forth in the documentary evidence of import licensing of the Ministry of Health.

Article 14 Package and transport vehicle of the imported dairy shall comply with safety and hygiene requirements, and transporting the dairy and toxic and harmful goods together is prohibited.

Article 15 There must be Chinese label and instructions for the imported prepackaged dairy while the label and instructions shall comply with China?ˉs relevant laws and regulations and national food safety standard.

Label of imported prepackaged dairy shall go through the inspection performed by relevant Inspection and Quarantine authority.

Article 16 Prior to gaining the qualification certificate of inspection and quarantine, the imported dairy shall be placed into a place designated or accepted by the inspection and quarantine authority while any unit or individual cannot use the above said place without permission of inspection and quarantine authority. 

 

Article 17 The inspection and quarantine authority shall perform the inspection and quarantine on the imported dairy by such means as examining the receipts according to letter of credit or contract, view of the scene, sensory inspection and inspection through labs.

Article 18 The imported dairy can be sold and consumed after passing the inspection and quarantine and receiving the Entry Goods Inspection and Quarantine Certificate. The Entry Goods Inspection and Quarantine Certificate of the imported dairy shall list out the following items: product name, brand, imported country (region), specification, quantity/weight, production date (batch number) and other items.

Article 19 In case of the imported dairy failing the inspection and quarantine, the inspection and quarantine authority shall issue a disqualification certificate. In case of the disqualified items are involved in safety, health and environment protection, the authority shall require the involved party to destroy the dairy or issue a letter of notice for goods returning report and the consignee shall do the procedures related to returning the imported dairy to the exporter. In case of other items being disqualified, certain technical handling can be done under supervision of the inspection and quarantine authority; the dairy can be sold and consumed if they pass the next inspection.

The consignee of the imported dairy shall seal up the disqualified dairy voluntarily prior to destroying the dairy or returning to the exporter and leave them alone in the a place designated or accepted by the inspection and quarantine authority while any unit or individual cannot use the above said place without permission of inspection and quarantine authority.

Article 20 The consignee of the imported dairy shall set up a recording system for dairy import and sale, giving a true recording of No. of Inspection and Quarantine Qualification Certificate, name, specification, quantity, production date, batch number, shelf life, exporter and purchaser of the imported dairy and their contact way, delivery date while the time for keep recording shall not be less than two years. ??

The inspection and quarantine authority shall examine the importing and sale records of the consignee in the jurisdiction.

Article 21 As to the imported dairy raw material which shall be exported after processing, the inspection and quarantine authority shall perform inspection under the compulsory standard of the to-be-exported country (region) or the contract, and ?°only for processing for export?± shall be put on the qualification certificate issued by the authority.

Article 22 The inspection and quarantine authority shall set up credit records for the consignee of the imported dairy.

Once discovering the imported dairy failing to the legal requirements, the inspection and quarantine authority may put the relevant consignee, inspector and the authorized agent into the list of bad credit record; as to the units in breach of laws and receiving the administrative penalty, the authority shall put them into the list of illegal enterprises and publicize.

Chapter III Dairy Exporting

Article 23 AQSIQ shall carry out a Recording for Reference (hereinafter referred to as ?°recording?±) for the enterprise engaged in dairy exporting while the recording shall be performed under relevant regulations of AQSIQ.

The exported dairy shall come from the dairy exporting enterprises with a recording.  

Article 24 Milk livestock farm for exporting raw milk shall get a recording for reference in the inspection and quarantine authority. Based on risk analysis, the authority shall inspect the animal epidemic disease, residue of agricultural and veterinary drugs, environmental contaminants and other toxic and harmful substances on the recorded farm.  

Article 25 The feeding stuff, feeding stuff additives and veterinary drugs prohibited by our country and the import country (region) and other substances causing direct or potential harm to animal and human beings cannot be used for feeding the livestock for producing the exported raw milk. The livestock for producing the exported raw milk shall be prohibited to produce raw milk during the required drug intake period and drug withdrawal period.

Article 26 Livestock farm for exporting raw milk production shall set up an archive for livestock bred for milk production, which contains the following items:

£¨1£?Species, number, reproduction record, labeling, source and date of entering and delivery out of the farm;

£¨2£?objects to consume the input products, source, name, time and usage amount of such input products as feeding stuff, feeding stuff additives and veterinary drugs;

£¨3£?conditions of quarantine, immunity and disinfection; 

£¨4£?Disposal of the sick, dead dairy stock and the disqualified raw milk;

£¨5£?Production, storage, inspection and sale of raw milk.

The record shall be true and be maintained for at least two years.

Article 27 The enterprise engaged in dairy export shall conform to the Good Manufacturing Practices (GMP). Our country encourages the dairy export enterprise to carry out the HACCP system. The enterprise that exports infants and young children formula shall set up a complete HACCP system.

Article 28 Enterprises engaged in exporting dairy products shall establish the following system:

£¨1£?examining system for purchasing raw material, food additives and relevant products, keep a true record of their names, size, quantity, supplier, supplier?ˉs contact way and purchase date;

£¨2£?set up an archive for production record and make a truthful record for safety management during food production process;

£¨3£?set up a delivery inspection system, inspect the to-be-delivered dairy by batch and keep inspection reports and retain the samples;

£¨4£?Set up a delivery inspection system for dairy, review the inspection qualification certificate of the delivery dairy and quality and safety conditions and keep a truthful record of products?ˉ name, size, quantity, production date, and shelf life, production batch, No. of the inspection qualification certificate, name of purchaser and contact way, sale date and others.

Ensure the above recording true and maintain the recording for at least two years.

Article 29 Producer and retailer of the exported dairy shall guarantee that the exported dairy shall conform to Chinese national food safety standard and conform to the standard set forth by the imported country (region) or to the requirements in the contract as well.

Article 30 The manufacturing enterprises of export dairy should inspect the raw materials and assistant materials in dairy processing and the finished products or entrust a qualified inspection authority  to inspect, and provide an inspection report.

Article 31 The packaging and mode of transportation of export dairy should comply with hygiene and safety requirements, and pass the inspection and quarantine.??

For the containers, cabins, aircraft, vehicles and other means of delivery used for shipping the perishable and the dairy needing freezing (refrigeration), the carrier, packing unit or its agent shall clean and disinfect the transport tools and containers and keep a good record, apply to the inspection and quarantine authority for the inspection of cargo-worthiness about cleaning, hygiene, refrigeration, and others; if  no inspection or failing to inspection,  loading or transporting is prohibited.

Article 32 The consignor of export dairy or its agent shall apply to the inspection and quarantine authority where the export dairy manufacturing enterprises is located for inspection and quarantine, in accordance with the provisions on application for inspection and quarantine set forth by  the AQSIQ.

Article 33 The inspection and quarantine authority sets up an export dairy sampling program in accordance with the risk condition of dairy products, the control level of safety, hygiene and quality of manufacturing enterprises, the records of safety, hygiene and quality on products, the previous cases of export, the requirements of importing countries (regions), and perform the inspection of export dairy in accordance with the following requirements:

(1) the National Food Safety Standards;

(2)  the bilateral agreements, protocol, memorandum;

(3)  the requirements of  laws and regulations of  the importing country (region);

(4) the inspection and quarantine requirements specified in trade contract or letter of credit;

(5) the requirements of other laws and regulations of China.

Article 34 After the inspection and quarantin, if the export dairy meet the relevant requirements, the inspection and quarantine authority shall issue "Commodity Inspection & Quarantine Certificate " or "export goods replacement voucher", and issue inspection and quarantine certificates in accordance with the requirement of importer; if the export dairy is disqualified, issue the "Letter of Notice for Disqualified Exported Goods", they shall not be exported.

Article 35 The inspection and quarantine authority in the exit port of export dairy exit check whether the goods and certificates are consistent, in accordance with the relevant provisions in exit goods replacement voucher inspection. Once passing the inspection, renew the "export goods the replacement voucher" issued by the inspection and quarantine authority  with "exit Customs Clearance of goods"; if failing to inspection, the port inspection and quarantine authority shall issue a disqualified certificate, and the dairy cannot be exported.

The  inspection and quarantine authority in the rpoduction place and the port inspection and quarantine authority shall establish an information exchange mechanism, and timely inform the hygiene and safety issues of export dairy discovered during the inspection and quarantine, and report to its superior  authority  in accordance with regulations.

Article 36 Export dairy production enterprises should establish the retrospective system of product, establish related archives to ensure retroactive effectiveness. The retention period of archives  should not be less than two years.

Article 37 Export dairy production enterprises should establish a management system, the sample storage conditions and time should be suitable for the characteristics of the product itself, the quantity and weight of the sample should satisfy the inspection requirements.

Article 38 If the inspection and quarantine authority discovers the export dairy which does not meet the statutory requirements, the producer and the operator can be included in the list of bad credit record; as to the units in breach of laws and receiving the administrative penalty,  the authority shall put them into the list of illegal enterprises and publicize.

 Chapter IV  Risk Alert

Article 39  AQSIQ and all its affiliated inspection and quarantine authority should establish import and export dairy safety information gathering network to gather and systemize dairy safety information about initiatively monitor, enforcing supervision, laboratory examination, overseas notification, local authority notification, news from media and network, complaints report, relevant authority transact, etc.

Article 40  Import and export dairy production and operating  units should establish risk information reporting system, formulate dairy safety risk information contingency plan and provide contingency liaisonperson; arrange full-time risk information reporter to report to the inspection and quarantine authority the discovered import and export dairy recall, disposal situation and other risk information without delay.

Article 41 The inspection and quarantine authorities should propose preliminary disposal suggestions to the approved and gathered import and export dairy safety information, and report to AQSIQ in accordance with specified provisions and procedure as well as notify local government and relevant authoritys.

Article 42  AQSIQ and the inspection and quarantine authorities directly subordinate to AQSIQ should release risk alert notification on the basis of alert level of import and export dairy safety risk information, and take following measures:

(1)    restraint on export and import conditionally, including strict monitor, tightened inspection, ordered to recalls, etc. ;

(2)    ban import or export, destroy on the spot or send back;

(3)    start import and export dairy safety contingency disposal pre-arranged planning.

Inspection and quarantine authorities shall take charge of organizing the  implementation of risk alert and control measures.

Article 43  If animal epidemic disease or other serious food safety events that may affect dairy safety took place in country (region) that exports dairy to China, AQSIQ can carry out the risk alert and control measures stated in Article 42 of this Measures on the import dairy in accordance with laws and regulations in China.

AQSIQ shall adjust risk alert and control measures after analyzing and assessing the latest epidemic situation, disposal results of food safety events and related data provided by the official department  and dairy producer of export country£¨region£?.

Article 44  When import and export dairy safety risk has disappeared or been reduced to an acceptable level, AQSIQ or its direct inspection and quarantine bureau shall release notification to remove the released risk alert and control measures.

Article 45  When import dairy exists safety issues, already or may endanger human health and life, the import dairy consignee should recall products initiatively and report to the local inspection and quarantine authority. The consignee should make public relevant information, inform wholesalers and sellers to suspend all wholesale and sell activities, notify consumers to stop using the related products, and record the dairy recall information.

The inspection and quarantine authority shall inspect the event after receipting report, and report to the superior in accordance with the coverage of the of import dairy.

If import dairy consignee don?ˉt recall the products initiatively, the inspection and quarantine authority directly subordinate to AQSIQ shall send a letter of norice for recall to it and report to AQSIQ. AQSIQ can issue risk alert notification or risk alert announcment, and take measures specified in Article 42 of this measure and other measures that can prevent harm from happening.

Article 46  If safety issues were discovered in the export dairy, already or may endanger human health and life, export dairy producer should take measures to avoid and reduce the harm and report to local inspection and quarantine authorities immediately.

Article 47  When carrying out the supervision and management responsibility upon the inspection and quarantine of import dairy, the inspection and quarantine authority is entitled to take following measures:

(1)      enter production and management place to conduct on-site inspection;

(2)      view, copy, seal up and detain relevant contract, bill, account book and other relevant information;

(3)      seal up and detain products inconformity with statutory requirements, raw materials, auxiliary materials, additives, agricultural inputs used illegally as well as tools and equipments for illegal production;

(4)      seal up production and management site having serious hidden danger to human health and life security.

Article 48  the Inspection and quarantine authority should report the adopted control measures to AQSIQ, and notify local government and department concerned in accordance with relevant provisions.

AQSIQ shall notify relevant departments concerning the related import and export dairy safety information and adopted control measures.

 

Chapter V   Legal responsibility

Article 49  If the inspection and quarantine results of import dairy don?ˉt meet the national food safety standards, for illegal selling and using activities, in accordance with the provisions in Article 89 and 85 of Food Safety Law, inspection and quarantine authorities shall seize the illegal income, dairy produced and operated illegally as well as the tools, equipments, raw materials and so on for illegal production and operation process; the total value of dairy of  illegal production and operation less than 10,000 yuan(RMB), the enterprise will be fined along with a penalty of 2000 yuan minimum to 50,000 yuan maximum; the currency sum more than 10,000 yuan, the enterprise will be fined along with a penalty of five to ten times of the value of goods; in serious circumstances, its register qualification will be revoked.

Article 50   If the exporters have such cases below, operating  the dairy export inconformity with national food safety standard , in accordance with the provisions in Article 89 and 85 of Food Safety Law, inspection and quarantine authorities shall seize the illegal income, dairy produced and operated illegally as well as the tools, equipments, raw materials and so on for illegal production and operation; the currency sum of illegal dairy production and operation less than 10,000 yuan, the enterprise will be fined along with a penalty between 2000 yuan to 50,000 yuan; the currency sum more than 10,000 yuan, the enterprise will be fined along with a penalty of five to ten times of the value of goods ; in cases of gross violation, its register qualification will be revoked:

(1)      not apply for inspection and quarantine, or export products not yet supervised and qualified without authorization;

(2)      export disqualified dairy without authorization;

(3)      exchange the export dairy supervised, sampling inspection, already issued the inspection and quarantine certification without authorization;

(4)     the export dairy from enterprises not registering in inspection and quarantine authorities.

Article 51  If exporters have any fraudful behavior other than those stated in Article 50, in accordance withspecific provisions of  Article 7, the inspection and quarantine authority shall seize the illegal income and dairy, meanwhile fine the enterprise a penalty of three times of the value of goods; if the activities constitute a crime, they shall be investigated of criminal liability in accordance with law.

Article 52  If the importers have such cases below, not establishing and obeying dairy export and sale recording system, in accordance with provisions in Article 89 and 87 of Food Safety Law, the inspection and quarantine authority shall order them to correct and give warning; those rejecting correction will be fined a penalty of 2000  yuan minimum to 20,000  yuan maximum; in serious circumstance, the enterprise will be ordered to stop production and businesses until cancelingits related register qualification.

(1)      not establishing dairy export and sale recording system;

(2)      incomprehensive and untrue  export and sale recording system;

(3)      the holding period of export and sale records less than two years,

(4)      alteration, damages, losses or other changes of records thereby cannot reflect actual situation;

(5)      forge and change the export and sale records.

Article 53  If importers have any fraudful behaviors other than those stated in Article 52 of this Measures, in accordance with specific provisions of Article 8, the inspection and quarantine authority shall seize the illegal income and dairy, meanwhile fine the enterprise a penalty of three times the currency sum; if the activities constitute a crime, they shall  be prosecuted for their criminal liability in accordance with law.

Article 54  If the importers have such cases below, the inspection and quarantine authority shall order them to correct, those having illegal income will be fined a penal of not more than three times illegal income and the maximum does not exceed 30,000 yuan; those not having illegal income will be fined a penalty of not more than 10,000yuan.

(1)  import dairy consignee haven't disposed the disqualified dairy within specified period in accordance within the spection and quarantine authority's  instruction;

(2)  import dairy consignee violates the provisions in Article 19 of this Measures and doesn?ˉt take necessary measures to seal up and place separately disqualified dairy before being destroyed or sent back;

(3)  import dairy consignee arbitrarily transfers the disqualified dairy away from the places designated or approved by the inspection and quarantine authority;

(4)  dairy stock farm illegally uses agricultural chemical inputs to export raw milk during farming process;

(5)  the related records of dairy stock farm of export raw milk are untrue or its holding period is less than three years;

(6) the enterprise of export dairy hasn?ˉt established traceability system or cannot ensure the availability of traceability system;

(7)  the enterprise of export dairy hasn?ˉt established sample management system or the retained samples are inconsistent with actual situations.

(8)  the enterprise of export dairy violates relevant packaging provisions of this Measures.

Article 53 there are other illegal acts of import and export dairy producers and operators, the inspection and quarantine authority and its personnel shall be punished in accordance with the provisions of relevant laws and regulations.

 

Chapter VI Supplementary Provisions


Article 54 The consignee and/or consigner of diary is entitled to apply for re-inspection in accordance
with the Management Measure on Re-inspection of Imported and Exported Commodities if it
disagrees with the result of inspection and quarantine.

Article 55 Dairy products which are for feedstuff, non-edible or imported/exported through express,
mailing or brought by passengers shall be handled in accordance with corresponding regulations.

Article 56 AQSIQ is responsible for interpreting this Measure.

Article 57 This Measure goes into force on May 1, 2013.

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