Protocol Between the Ministry of Health of The
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PROTOCOL BETWEEN THE MINISTRY OF HEALTH OF THE ITALIAN REPUBLIC AND THE GENERAL ADMINISTRATION OF CUSTOMS OF THE PEOPLE'S REPUBLIC OF CHINA ON INSPECTION, QUARANTINE AND VETERINARY SANITARY REQUIREMENTS FOR BEEF TO BE EXPORTED FROM ITALY TO CHINA The Ministry of Health of the Italian Republic (hereinafter referred to as MH) and the General Administration of Customs of the People's Republic of China (hereinafter referred to as GACC) have entered into the following Protocol on inspection, quarantine, and veterinary health requirements for beef to be exported from the Italian Republic (hereinafter referred to as Italy) to the People's Republic of China (hereinafter referred to as China). Article 1 The General Directorate for Hygiene, Food Safety and Nutrition and the General Directorate of Animal Health and Veterinary Drugs of MH are the Competent Italian Authorities responsible respectively for the supervision, inspection and quarantine over food production of animal origin and for the animal diseases and management control measures, feed and veterinary drugs. The General Directorates are responsible to coordinate and supervise the activities granting that safety products are exported from Italy to China. Those activities are performed at local level by Official Veterinarians working at local Competent Authority. The Official Veterinarians are appointed as the competent persons to sign the official Veterinary Health Certificate jointly decided with GACC. Article 2 MH will provide GACC with the Italian laws and regulations governing the slaughter, cutting, processing and storage of beef to be exported to China, the relevant inspection and quarantine programs which consist of monitoring programs, laboratory testing methods and procedures; and the veterinary inspection stamps or marks for export eligibility. MH will provide GACC in an appropriate way with the following information every year: 1. The plans and annual reports of the national residue monitoring and control program and the national microbiological monitoring program. If applicable, nuclear radiation and other environmental pollutants monitoring program and reports will be included. 2. The preventive and control measures applied against the diseases listed in Page 1 of 8 Article 3 of this Protocol, including but not limited to, specific geographical location of zoning, number of livestock within the zone, detail of the meat processing establishments for export and information on official supervision and controls. 3. The measures or relevant updates that have been taken to reduce the risk of Bovine Spongiform Encephalopathy (BSE) as a country having negligible risk for BSE, as recognized by the World Organization for Animal Health (OIE); 4. The implementation and verification of the ban on feeding ruminants with any meat-and-bone meal and greaves derived from ruminants; and, 5. The epidemic disease situation in cattle of concern for both Parties. The Italian administrative systems for food safety will comply with the requirements of China. When necessary, GACC may delegate experts to visit Italy, regularly or randomly, to conduct an on-site audit or retrospective inspection. MH will provide necessary assistance to enable the audit. MH will share with GACC periodic verification information conducted by the Competent Authority on production, exportation as well as the sanitary and safety situations of the establishments that intend to export. Both Parties will establish an efficient information reporting mechanism to cooperate on investigating and handling issues; taking corrective and preventive actions to ensure the exporting establishments meet the requirements of China. Article 3 MH confirms that: 1. the Italian territory is free from foot and mouth disease, contagious bovine pleuropneumonia, lumpy skin disease, peste des petits ruminants and rinderpest; and, 2. the BSE monitoring of cattle, the national feed ban, Specified Risk Materials (SRMs) control measures have been carried out and an effectively cattle traceability system has been established according to the recommendations of the OIE, and appropriate risk control measures for BSE have been applied as a country recognized by the OIE having negligible risk for BSE. Article 4 The live cattle from which the beef to be exported to China is derived: 1. Are born, reared and slaughtered in Italy; have a unique identification mark that can be traced back to the farm of birth and rearing; 2. Originate from farms not having any risk of BSE and where there are not suspect or confirmed cases of BSE, or of their progeny or members of the known birth cohort (not be born in the same herd of the BSE case, and within 12 months of the Page 2 of 8 birth of the BSE case) or of the feed cohort of a BSE case; 3. Originate from farms where there has been no clinical case of bluetongue, brucellosis, anthrax, tuberculosis, paratuberculosis, bovine viral diarrhea/mucosal disease, Q fever, enzootic bovine leukosis, infectious bovine rhinotracheitis/infectious pustular vulvovaginits, and bovine genital campyobacterosis for the past 12 months prior to slaughter; 4. Originate from premises not under quarantine or movement restriction due to other notified diseases in accordance with the OIE, Italy and China's animal health regulations for the past 6 months prior to slaughter; 5. Have never been fed with meat-and-bone meal or greaves derived from ruminants; 6. Have not been vaccinated against anthrax using live vaccine during the 14 days prior to slaughter; and, 7. Are less than 30 months of age at the time of slaughter. Article 5 The establishments (including slaughtering, cutting, processing and storage) which intend to export beef to China will be under supervision of the Italian Competent Authorities and in compliance with the relevant laws and regulations of Italy and China on veterinary and public health. The establishments for export of beef to China will be registered with GACC as per the Food Safety Law of the People’s Republic of China and Regulations on the Implementation of Law of the People's Republic of China on the Entry and Exit Animal and Plant Quarantine. Beef from establishments that are not registered with GACC will not be allowed to be exported to China. Article 6 The Italian Official Veterinarians will attest, through the Veterinary Health Certificate, that: 1. The beef is derived from cattle that: 1. Are born, reared and slaughtered in Italy, have a unique identification mark that can be traced back to the farm of birth and rearing; 2. Have not been administered with restricted veterinary drugs or feed additives prohibited by China and Italy; 3. Are in conformity with Article 4 of this Protocol; 4. Have been subjected to ante- and post-mortem inspections with favorable results in accordance with the relevant Italian regulations and import requirements of China; 5. Are healthy and free of clinical signs of infectious disease, and no lesion has been found on the carcasses and viscera, from which the major lymphatic nodes, and glands have been removed; Page 3 of 8 6. Were under 30 months of age at the time of slaughter. 2. During the slaughter process the cattle were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a pithing process; 3. The tonsils, distal ileum, brains, eyes, spinal cord, skull, vertebral column, dorsal root ganglion (DRG) have been removed in a safe and sanitary manner to avoid contamination according to the regulations of the European Union (EU) and Italy; 4. The beef exported to China is subject to the national residue monitoring and control program, and the residue level of the veterinary medicinal products, pesticides and environmental pollutant such as heavy metals, as well as other undesirable substances contained in the products do not exceed the Maximum Residue Limits (MRLs) stipulated by EU, China and Italy; the veterinary medicinal products and feed additives prohibited by both Parties should not be detected; 5. The beef exported to China is subject to the national microbiological monitoring program and is free from contamination of pathogenic microorganisms prescribed in the laws and regulations of China, the EU and Italy; and, 6. The beef is hygienic, safe, and fit for human consumption. Article 7 1. During the period of transportation to the slaughterhouse and at the slaughterhouse, the cattle for slaughter and for export to China will not enter into contact with: a. Animals of other species; b. Any live cattle which do not comply with the requirements as per Articles 3 and 4 of this Protocol; or c. Any live cattle or other animal species from an establishment which has not achieved registration as prescribed in Article 5 of this Protocol. 2. The beef for export to China will not be processed along with the following products: a. Products of other animal species; b. Animal products that do not conform to Articles 3 and 4 of this Protocol; or c. Products that are not produced by this establishment; or d. Products that are not exported to China. Beef to be exported to China in freezer or chiller will be stored in a separate place that is clearly identified. Page 4 of 8 Article 8 The beef exports to China will be packed with unused new packaging materials in compliance with China's national food safety standards and international hygienic standards. The beef exports to China will be labeled with the product name, country of origin, establishment registration number and the batch number on the interior independent package. The product name, country of origin, product specifications, place of origin (specifying the province and city), establishment registration number, batch number, destination (People’s Republic of China will be specified as the destination), production date (year/month/day), shelf life and storage temperature will be labeled on the exterior package in Chinese. The official meat inspection mark used by the Italian authorities will be identified on the exterior package.