Sanitary requirements for export of untreated 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 (C)
HA 2110 (Amended October 21, 2013)

II. Health information

II.1. the blood products described above consist of blood products that satisfy the health 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 or in the establishment of collection, 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 derived from the production of products intended for human consumption;]
  • and/or [- blood and blood products originating from live animals that did not show signs of any disease communicable through that product to humans or animals;]
  • and/or [- animal by-products 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 level laid down in 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 the case of blood products derived from animals belonging to the taxa Artiodactyla, Perissodactyla and Proboscidea, including their crossbreds, the products come:

II.5.1. from a country 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.5.2.

  • either [from the third countries, territories or parts thereof…… (ISO code in case of country or codes for territories or parts thereof) 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 [from the countries, territories or parts thereof…… (ISO code in case of country or codes for territories or parts thereof) 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;]]

[II.5.3. In addition, in case of animals other than Suidae and Tayassuidae:

  • either [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 in which vaccination has not been carried out against those diseases for at least 12 months;]
  • or [in the country or region of origin vesicular stomatitis and bluetongue seropositive animals are present;]]

[II.5.4. In addition, in case of Suidae and Tayassuidae:

II.5.4.1. 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 and vaccination has not been carried out against those diseases for at least 12 months in the susceptible species and

II.5.4.2. either [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 in which vaccination has not been carried out against this disease for at least 12 months;]

II.5.4.2. or [in the country or region of origin vesicular stomatitis seropositive animals are present;]

[II.6. in the case of blood products derived from poultry or other avian species the animals and the products come from the territory of the country or region with code … which has been free from Newcastle disease and highly pathogenic avian influenza as defined in the Terrestrial Animal Health Code of the OIE, which for at least 12 months has not carried out vaccination against avian influenza, where the animals 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;]

II.7. 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,] The outer packaging or containers bear labels indicating "NOT FOR HUMAN OR ANIMAL CONSUMPTION";

II.8. the products were stored in enclosed storage;

II.9. all precautions were taken to avoid contamination of the products with pathogenic agents during transport;

II.10.

  • 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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