6.

Annex IX is replaced by the following: ‘ANNEX IX IMPORTATION INTO THE UNION OF LIVE ANIMALS, EMBRYOS, OVA AND PRODUCTS OF ANIMAL ORIGIN CHAPTER B Imports of bovine animals SECTION A Imports from a country or a region with a negligible BSE risk Imports of bovine animals from a country or a region with a negligible BSE risk shall be subject to the presentation of an animal health certificate attesting that: (a) the animals were born and continuously reared in a country or region or countries or regions classified in accordance with Commission Decision 2007/453/EC (*****) as countries or regions posing a negligible BSE risk; (b) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and have not been exposed to the following bovine animals: (i) all BSE cases; (ii) all bovine animals which, during their first year of life, were reared with the BSE cases during their first year of life, and which investigation showed consumed the same potentially contaminated feed during that period; or (iii) if the results of the investigation referred to in indent (ii) are inconclusive, all bovine animals born in the same herd as, and within 12 months of the birth of, the BSE cases; and (c) if there have been BSE indigenous cases in the country concerned, the animals were born: (i) after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants, as defined in the OIE Terrestrial Animal Health Code, has been effectively enforced; or (ii) after the date of birth of the last BSE indigenous case if born after the date of the feed ban referred to in indent (i). SECTION B Imports from a country or a region with a controlled BSE risk Imports of bovine animals from a country or a region with a controlled BSE risk shall be subject to the presentation of an animal health certificate attesting that: (a) the country or region is classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk; (b) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and have not been exposed to the following bovine animals: (i) all BSE cases; (ii) all bovine animals which, during their first year of life, were reared with the BSE cases during their first year of life, and which investigation showed consumed the same potentially contaminated feed during that period; or (iii) if the results of the investigation referred to in indent (ii) are inconclusive, all bovine animals born in the same herd as, and within 12 months of the birth of, the BSE cases; (c) the animals were born: (i) after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants, as defined in the OIE Terrestrial Animal Health Code, has been effectively enforced; or (ii) after the date of birth of the last BSE indigenous case if born after the date of the feed ban referred to in indent (i). SECTION C Imports from a country or a region with undetermined BSE risk Imports of bovine animals from a country or a region with an undetermined BSE risk shall be subject to the presentation of an animal health certificate attesting that: (a) the country or region has been categorised in accordance with Decision 2007/453/EC as a country or region with undetermined BSE risk; (b) the feeding of ruminants with meat-and-bone meal and greaves from ruminants, as defined in the OIE Terrestrial Animal Health Code, has been banned and the ban has been effectively enforced in the country or region; (c) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and have not been exposed to the following bovine animals: (i) all BSE cases; (ii) all bovine animals which, during their first year of life, were reared with the BSE cases during their first year of life, and which investigation showed consumed the same potentially contaminated feed during that period; or (iii) if the results of the investigation referred to in indent (ii) are inconclusive, all bovine animals born in the same herd as, and within 12 months of the birth of, the BSE cases; (d) the animals were born: (i) at least two years after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants, as defined in the OIE Terrestrial Animal Health Code, has been effectively enforced; or (ii) after the date of birth of the last BSE indigenous case if born after the date of the feed ban referred to in indent (i). CHAPTER C Imports of products of animal origin from bovine, ovine or caprine animals SECTION A Products The following products of bovine, ovine and caprine origin, as defined in the following points of Annex I to Regulation (EC) No 853/2004, shall be subject to the conditions set out in Sections B, C or D of this Chapter depending on the BSE risk category of the country of origin: — fresh meat, as defined in point 1.10 thereof, — minced meat, as defined in point 1.13 thereof, — mechanically separated meat, as defined in point 1.14 thereof, — meat preparations, as defined in point 1.15 thereof, — meat products, as defined in point 7.1 thereof, — rendered animal fat, as defined in point 7.5 thereof, — greaves, as defined in point 7.6 thereof, — gelatine, as defined in point 7.7 thereof, other than derived from hides and skins, — collagen, as defined in point 7.8 thereof, other than derived from hides and skins, — treated stomachs, bladders and intestines, as defined in point 7.9 thereof. SECTION B Imports from a country or a region with a negligible BSE risk Imports of products of bovine, ovine and caprine animal origin referred to in Section A from a country or a region with a negligible BSE risk shall be subject to the presentation of an animal health certificate attesting that: (a) the country or region is classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk; (b) the animals from which the products of bovine, ovine and caprine animal origin were derived passed ante mortem and post mortem inspections; (c) the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in point 1 of Annex V to this Regulation; (d) if the animals, from which the products of bovine animal origin were derived, originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a controlled or an undetermined BSE risk, by way of derogation from point (c) of this Section, carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be imported. In the case of such imports, the carcasses or wholesale cuts of carcasses of bovine animals containing a vertebral column which is defined as specified risk material in accordance with point 1 of Annex V to this Regulation shall be identified by a clearly visible red stripe on the label referred to in Article 13 or 15 of Regulation (EC) No 1760/2000. Furthermore, specific information on the number of bovine carcasses or wholesale cuts of carcasses, from which the removal of the vertebral column is required, shall be added to the Common Veterinary Entry Document (CVED) referred to in Article 2(1) of Regulation (EC) No 136/2004; (e) the products of bovine, ovine and caprine animal origin do not contain and are not derived from mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except if the animals, from which the products of bovine, ovine and caprine animal origin are derived, were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there has been no BSE indigenous cases; (f) the animals from which the products of bovine, ovine and caprine animal origin were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, except if the animals from which the products of bovine, ovine and caprine animal origin are derived, were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk; (g) if the animals, from which the products of bovine, ovine and caprine animal origin were derived, originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk, the animals have not been fed with meat-and-bone meal or greaves, as defined in the OIE Terrestrial Animal Health Code; (h) if the animals, from which the products of bovine, ovine and caprine animal origin were derived, originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk, the products were produced and handled in a manner which ensures that they did not contain and were not contaminated with nervous and lymphatic tissues exposed during the deboning process. SECTION C Imports from a country or a region with a controlled BSE risk 1. Imports of products of bovine, ovine and caprine animal origin referred to in Section A from a country or a region with a controlled BSE risk shall be subject to the presentation of an animal health certificate attesting that: (a) the country or region is classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk; (b) the animals from which the products of bovine, ovine and caprine animal origin were derived passed ante mortem and post mortem inspections; (c) the animals from which the products of bovine, ovine and caprine animal origin destined for export were derived have not been killed, after stunning, by laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity; (d) the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in point 1 of Annex V to this Regulation, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals. 2. For products of bovine animal origin, by way of derogation from point 1(d) carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be imported. 3. When the removal of the vertebral column is required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column, shall be identified by a clearly visible red stripe on the label referred to in Article 13 or 15 of Regulation (EC) No 1760/2000. 4. The number of bovine carcasses or wholesale cuts of carcasses, from which the removal of the vertebral column is required shall be added to the Common Veterinary Entry Document (CVED) referred to in Article 2(1) of Regulation (EC) No 136/2004 in the case of imports. 5. In the case of intestines originally sourced from a country or a region with a negligible BSE risk, imports of treated intestines shall be subject to the presentation of an animal health certificate attesting that: (a) the country or region is classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk; (b) the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country or region with a negligible BSE risk and passed ante mortem and post mortem inspections; (c) if the intestines are sourced from a country or region where there have been BSE indigenous cases: (i) the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been enforced; or (ii) the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in point 1 of Annex V to this Regulation. SECTION D Imports from a country or a region with an undetermined BSE risk 1. Imports of products of bovine, ovine and caprine animal origin referred to in Section A from a country or a region with an undetermined BSE risk, shall be subject to the presentation of an animal health certificate attesting that: (a) the animals from which the products of bovine, ovine and caprine animal origin were derived have not been fed meat-and-bone meal or greaves derived from ruminants, as defined in the OIE Terrestrial Animal Health Code, and passed ante mortem and post mortem inspections; (b) the animals from which the products of bovine, ovine and caprine animal origin were derived have not been killed, after stunning, by laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity; (c) the products of bovine, ovine and caprine animal origin do not contain and are not derived from: (i) specified risk material as defined in point 1 of Annex V to this Regulation; (ii) nervous and lymphatic tissues exposed during the deboning process; (iii) mechanically separated meat obtained from bones of bovine, ovine or caprine animals. 2. For products of bovine animal origin, by way of derogation from point 1(c), carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be imported. 3. When removal of the vertebral column is required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column, shall be identified by a clearly visible red stripe on the label referred to in Article 13 or 15 of Regulation (EC) No 1760/2000. 4. Specific information on the number of bovine carcasses or wholesale cuts of carcasses, from which removal of the vertebral column is required shall be added to the Common Veterinary Entry Document (CVED) referred to in Article 2(1) of Regulation (EC) No 136/2004 in the case of imports. 5. In the case of intestines originally sourced from a country or a region with a negligible BSE risk, imports of treated intestines shall be subject to the presentation of an animal health certificate attesting that: (a) the country or region is classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk; (b) the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country or region with a negligible BSE risk and passed ante mortem and post mortem inspections; (c) if the intestines are sourced from a country or region where there have been BSE indigenous cases: (i) the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or (ii) the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in point 1 of Annex V to this Regulation. CHAPTER D Imports of animal by-products and derived products from bovine, ovine and caprine origin SECTION A Animal by-products This Chapter shall apply to the following animal by-products, as defined in points (1) of Article 3 of Regulation (EC) No 1069/2009 and the following derived products as defined in point (2) of that Article, provided that those animal by-products and derived products are of bovine, ovine and caprine animal origin: (a) rendered fats derived from Category 2 material, which are intended to be used as organic fertilisers or soil improvers, as defined in point 22 of Article 3 of Regulation (EC) No 1069/2009; (b) bones and bone products derived from Category 2 material; (c) rendered fats derived from Category 3 material which are intended to be used as organic fertilisers or soil improvers or as feed, as defined in points 22 and 25 respectively of Article 3 of Regulation (EC) No 1069/2009, or their starting materials; (d) pet food including dog chews; (e) blood products; (f) processed animal protein; (g) bones and bone products derived from Category 3 material; (h) gelatine and collagen derived from materials other than hides and skins; (i) Category 3 material and derived products other than those referred to in points (c) to (h) excluding: (i) fresh hides and skins, treated hides and skins; (ii) gelatine and collagen derived from hides and skins; (iii) fat derivatives. SECTION B Health certificate requirements Imports of the animal by-products and derived products of bovine, ovine and caprine origin referred to in Section A shall be subject to the presentation of a health certificate which has been completed with the following attestation: (a) the animal by-product or derived product: (i) does not contain and is not derived from specified risk material as defined in point 1 of Annex V to this Regulation; and (ii) does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except if the animals, from which the animal by-product or derived product are derived, were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk, in which there has been no BSE indigenous cases; and (iii) is derived from animals which have not been killed, after stunning, by laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC; or (b) the animal by-product or derived product does not contain and is not derived from bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC. In addition to points (a) and (b) of this Section, imports of the animal by-products and derived products referred to in Section A, containing milk or milk products of ovine or caprine animal origin and intended for feed, shall be subject to the presentation of a health certificate which has been completed with the following attestation: (c) the ovine and caprine animals from which those animal by-products or derived products have been derived have been kept continuously since birth in a country where the following conditions are fulfilled: (i) classical scrapie is compulsorily notifiable; (ii) an awareness, surveillance and monitoring system is in place; (iii) official restrictions apply to holdings of ovine or caprine animals in case of a suspicion of TSE or a confirmation of classical scrapie; (iv) ovine and caprine animals affected with classical scrapie are killed and completely destroyed; (v) the feeding to ovine and caprine animals of meat-and-bone meal or greaves of ruminant origin, as defined in the OIE Terrestrial Animal Health Code, has been banned and effectively enforced in the whole country for a period of at least the preceding seven years; (d) the milk and milk products of ovine or caprine animals originate from holdings where no official restriction is imposed due to a suspicion of TSE; (e) the milk and milk products of ovine or caprine animals originate from holdings where no case of classical scrapie has been diagnosed during the preceding seven years or, following the confirmation of a case of classical scrapie: (i) all ovine and caprine animals on the holding have been killed and destroyed or slaughtered, except for breeding rams of the ARR/ARR genotype, breeding ewes carrying at least one ARR allele and no VRQ allele and other ovine animals carrying at least one ARR allele; or (ii) all animals in which classical scrapie was confirmed have been killed and destroyed, and the holding has been subjected for two years at least since the confirmation of the last classical scrapie case to intensified TSE monitoring, including testing with negative results for the presence of TSE in accordance with the laboratory methods set out in Annex X, Chapter C, point 3.2, of all of the following animals which are over the age of 18 months, except ovine animals of the ARR/ARR genotype: — animals which have been slaughtered for human consumption, and — animals which have died or been killed on the holding but which were not killed in the framework of a disease eradication campaign. CHAPTER E Imports of ovine and caprine animals Ovine and caprine animals imported into the Union shall be subject to the presentation of an animal health certificate attesting that they have been kept continuously since birth in a country where the following conditions are fulfilled: (1) classical scrapie is compulsorily notifiable; (2) an awareness, surveillance and monitoring system is in place; (3) ovine and caprine animals affected with classical scrapie are killed and completely destroyed; (4) the feeding to ovine and caprine animals of meat-and-bone meal or greaves of ruminant origin, as defined in the OIE Terrestrial Animal Health Code, has been banned and effectively enforced in the whole country for a period of at least the preceding seven years. In addition to the conditions set out in points 1 to 4, the animal health certificate shall attest that: (5) For ovine and caprine animals for breeding imported into the Union and intended for Member States other than those with a negligible risk of classical scrapie or those with an approved national scrapie control programme listed in point 3.2 of Section A of Chapter A of Annex VIII, the following conditions have been complied with: (a) the imported ovine and caprine animals come from a holding or holdings that have complied with the conditions of point 1.3 of Section A of Chapter A of Annex VIII; or (b) they are ovine animals of the ARR/ARR prion protein genotype and they come from a holding where no official movement restriction has been imposed due to BSE or classical scrapie during the last two years. (6) For ovine and caprine animals for all uses except immediate slaughter imported into the Union and intended for a Member State with a negligible risk of classical scrapie or with an approved national scrapie control programme listed in point 3.2 of Section A of Chapter A of Annex VIII, the following conditions have been complied with: (a) they come from a holding or holdings that have complied with the conditions of point 1.2 of Section A of Chapter A of Annex VIII; or (b) they are ovine animals of the ARR/ARR prion protein genotype and they come from a holding where no official movement restriction has been imposed due to BSE or classical scrapie during the last two years. CHAPTER F Imports of products of animal origin from farmed and wild cervid animals 1. When fresh meat, minced meat, meat preparations and meat products as defined in points 1.10, 1.13, 1.15 and 7.1 respectively of Annex I to Regulation (EC) No 853/2004, derived from farmed cervid animals, are imported into the Union from Canada or the United States of America, the health certificates shall be accompanied by a declaration signed by the competent authority of the country of production, worded as follows: “This product contains or is derived exclusively from meat, excluding offal and spinal cord, of farmed cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognised by the competent authority with negative results and is not derived from animals coming from a herd where chronic wasting disease has been confirmed or is officially suspected.” 2. When fresh meat, minced meat, meat preparations and meat products as defined in points 1.10, 1.13, 1.15 and 7.1 respectively of Annex I to Regulation (EC) No 853/2004, derived from wild cervid animals, are imported into the Union from Canada or the United States of America, the health certificates shall be accompanied by a declaration signed by the competent authority of the country of production, worded as follows: “This product contains or is derived exclusively from meat, excluding offal and spinal cord, of wild cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognised by the competent authority with negative results and is not derived from animals coming from a region where chronic wasting disease has been confirmed in the last three years or is officially suspected.” CHAPTER H Import of ovine and caprine semen and embryos Ovine and caprine semen and embryos imported into the Union shall be subject to the presentation of an animal health certificate attesting that: (1) the donor animals have been kept continuously since birth in a country where the following conditions are fulfilled: (a) classical scrapie is compulsorily notifiable; (b) an awareness, surveillance and monitoring system is in place; (c) ovine and caprine animals affected with classical scrapie are killed and completely destroyed; (d) the feeding to ovine and caprine animals of meat-and-bone meal, or greaves of ruminant origin, as defined in the OIE Terrestrial Animal Health Code, has been banned and effectively enforced in the whole country for a period of at least the preceding seven years; and (2) the donor animals have been kept continuously for a period of three years preceding the date of the collection of the exported semen or embryos in a holding or holdings which have satisfied during that period all the requirements set out in point 1.3.(a) to (f) of Section A of Chapter A of Annex VIII except where the holding is a semen collection centre, provided that the semen collection centre complies with the conditions set out in point 1.3.(c)(iv) of that Section; or (a) in the case of semen of animals of the ovine species, the semen has been collected from male animals of the ARR/ARR prion protein genotype; or (b) in the case of embryos of animals of the ovine species, the embryos carry at least one ARR allele. (*****) Commission Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84).’"