Sanitary requirements for export of treated blood products, excluding of equidae, for the manufacture of derived products for purposes outside the feed chain for farmed animals, intended for dispatch to or for transit through the European Union Chapter 4 (D)
HA 2461 (Amended October 21, 2013)

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II. Health information

II.1. the blood products described above consist of blood products that satisfy the requirements below;

II.2. they consist exclusively of blood products not intended for human or animal consumption;

II.3. they have been prepared and stored in a plant supervised by the competent authority, exclusively with the following animal by-products:

  • either [- blood of slaughtered animals, which is fit for human consumption in accordance with Union legislation, but is not intended for human consumption for commercial reasons;]
  • and/or [- blood of slaughtered animals, which is rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of diseases communicable to humans or animals, derived from carcases that have been slaughtered in a slaughterhouse and were considered fit for human consumption following an ante-mortem inspection in accordance with Union legislation;]
  • and/or [- blood of slaughtered animals, which did not show any signs of diseases communicable to humans or animals, obtained from animals that have been slaughtered in a slaughterhouse after having been considered fit for human consumption following an ante-mortem inspection in accordance with Union legislation;]
  • and/or [- blood and blood products originating from live animals that did not show clinical signs of any disease communicable through these products to humans or animals;]
  • and/or [- animal by-products which have been derived from animals which have been submitted to illegal treatment as defined in Article 1(2)(d) of Directive 96/22/EC or Article 2(b) of Directive 96/23/EC;]
  • and/or [- animal by-products containing residues of other substances and environmental contaminants listed in Group B(3) of Annex I to Directive 96/23/EC, if such residues exceed the permitted levels laid down by Union legislation or, in the absence thereof, in national legislation;]

II.4. the blood from which such products are manufactured has been collected in slaughterhouses approved in accordance with Union legislation, in slaughterhouses approved and supervised by the competent authority of the country of collection or from live animals in facilities approved and supervised by the competent authority of the country of collection.

[II.5. In case of blood products derived from Artiodactyla, Perissodactyla and Proboscidea including their crossbreeds, other than Suidae and Tayassuidae, the products have undergone one of the following treatments, guaranteeing the absence of pathogens of foot-and-mouth disease, vesicular stomatitis, rinderpest, peste des petits ruminants, Rift Valley fever and bluetongue:

  • either [heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check;]
  • and/or [irradiation at 25 kGy by gamma rays, followed by an effectiveness check;]
  • and/or [change in pH to pH 5 for two hours, followed by an effectiveness check;]
  • and/or [heat treatment of at least 80 °C throughout their substance, followed by an effectiveness check.]]

[II.6. In the case of blood products derived from Suidae, Tayassuidae, poultry and other avian species, the products have undergone one of the following treatments guaranteeing the absence of pathogens of the following diseases: foot-and-mouth disease, vesicular stomatitis, swine vesicular disease, classical swine fever, African swine fever, Newcastle disease and highly pathogenic avian influenza, as appropriate to the species:

  • either [heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check;]
  • and/or [irradiation at 25 kGy by gamma rays, followed by an effectiveness check;]
  • and/or [heat treatment of at least 80 °C for Suidae/Tayassuidae and at least 70°C for poultry and other avian species throughout their substance, followed by an effectiveness check]].

[II.7. In the case of blood products derived from species other than listed in points II.5 or II.6 the products have undergone of the following treatment (please specify):space .]

II.8. The products were:

  • either [packed in new or sterilised bags or bottles,]
  • or [transported in bulk in containers or other means of transport that were thoroughly cleaned and disinfected with a disinfectant approved by the competent authority before use;] and the outer packaging or containers bear labels indicating "NOT FOR HUMAN OR ANIMAL CONSUMPTION";

II.9. the products were stored in enclosed storage;

II.10. all precautions were taken to avoid contamination of the products with pathogenic agents after treatment;

II.11.

  • either [the product does not contain and is not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council or mechanically separated meat obtained from bones of bovine, ovine or caprine animals; and the animals from which the product is 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 of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity.]
  • or [the product does not contain and is not derived from bovine, ovine or 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 by a decision in accordance with Article 5(2) of Regulation (EC) No 999/2001.]
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