(1)

In Annex VIII, Chapter IV is replaced by the following: ‘CHAPTER IV Requirements for blood and blood products, excluding from equidae, for the manufacture of technical products A. Importation 1. Imports of blood are subject to the requirements laid down in Chapter XI. 2. Member States must authorise imports of blood products for the manufacture of technical products, including material originating from animals to which substances prohibited pursuant to Directive 96/22/EC have been administered, if they: (a) come from third countries that appear on the list in Part VI (A) of Annex XI as applicable; (b) come from a technical plant meeting the specific conditions laid down in this Regulation or from the establishment of collection; (c) are accompanied by a health certificate that conforms to the model set out in Chapter 4(C) or Chapter 4(D) of Annex X as appropriate. 3. The blood from which blood products for the manufacture of technical products are produced must have been collected: (a) in slaughterhouses approved in accordance with Community legislation; (b) in slaughterhouses approved and supervised by the competent authority of the third country; or (c) from live animals in facilities approved and supervised by the competent authority of the third country. 4. In the case of blood products for the manufacture of technical products which have been derived from animals belonging to the taxa Artiodactyla, Perissodactyla and Proboscidea, including their crossbreeds, they must comply with the conditions of either points (a) or (b): (a) the products have undergone one of the following treatments guaranteeing the absence of pathogens of the diseases referred to in point (b): (i) heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check, (ii) irradiation at 25 kGy by gamma rays, followed by an effectiveness check, (iii) heat treatment of at least 80 °C throughout their substance, followed by an effectiveness check, (iv) in the case of animals other than Suidae and Tayassuidae only: change in pH to pH 5 for two hours, followed by an effectiveness check; (b) in case of blood products not treated in accordance with point (a) the products originate from a country or region: (i) where no case of rinderpest, peste des petits ruminants and Rift Valley fever has been recorded for 12 months and in which vaccination has not been carried out against those diseases for at least 12 months, (ii) where no case of foot-and-mouth disease has been recorded for 12 months and in which vaccination has not been carried out against this disease for at least 12 months, or where no case of foot-and-mouth disease has been recorded for 12 months and in which vaccination programmes against foot-and-mouth disease are being officially carried out and controlled in domestic ruminant animals for at least 12 months; in this case, following the border check provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the products must be transported directly to the technical plant of destination and all precautions, including safe disposal of waste, unused or surplus material, must be taken to avoid risks of spreading diseases to animals or humans. In addition to points (i) and (ii), in the case of animals other than Suidae and Tayassuidae, one of the following conditions must be complied with: — in the country or region of origin no case of vesicular stomatitis and bluetongue (including the presence of seropositive animals) has been recorded for 12 months and vaccination has not been carried out against those diseases for at least 12 months in the susceptible species, — following the border check provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the products must be transported directly to the technical plant of destination and all precautions, including safe disposal of waste, unused or surplus material, must be taken to avoid risks of spreading diseases to animals or humans. In addition to points (i) and (ii), in the case of Suidae and Tayassuidae, in the country or region of origin no case of swine vesicular disease, classical swine fever and African swine fever has been recorded for at least 12 months, vaccination has not been carried out against those diseases for at least 12 months and one of the following conditions are complied with: — in the country or region of origin no case of vesicular stomatitis (including the presence of seropositive animals) has been recorded for 12 months and vaccination has not been carried out against this disease for at least 12 months in the susceptible species, — following the border check provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the products must be transported directly to the technical plant of destination and all precautions, including safe disposal of waste, unused or surplus material, must be taken to avoid risks of spreading diseases to animals or humans. 5. In the case of blood products for the manufacture of technical products which have been derived from poultry and other avian species, they must comply with the conditions of either points (a) or (b): (a) the products have undergone one of the following treatments guaranteeing the absence of pathogens of the diseases referred to in point (b): (i) heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check, (ii) irradiation at 25 kGy by gamma rays, followed by an effectiveness check, (iii) heat treatment of at least 70 °C throughout their substance, followed by an effectiveness check; (b) in case of blood products not treated in accordance with point (a) the products originate from a country or region: (i) which has been free from Newcastle disease and highly pathogenic avian influenza as defined in the Terrestrial Animal Health Code of the OIE, (ii) which during the last 12 months has not carried out vaccination against avian influenza, (iii) where the poultry or other avian species from which the products derive have not been vaccinated against Newcastle disease with vaccines prepared from a Newcastle disease master strain showing a higher pathogenicity than lentogenic virus strains.’