Sanitary requirements for import of blood and blood products from equidae to be used outside the feed chain, for dispatch to or for transit through the European Union Chapter 4 (A)
HA 2118 (Amended October 21, 2013)

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II. Health Information

II.1. consist of blood or blood products from equidae that satisfy the health requirements below;

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

II.3. have been obtained from animals that originate from the EU Member States or from a third country, territory or part thereof listed in the column "third countries' lists" of row No 3 of Table 2 in Section 1 of Chapter II of Annex XIV to Regulation (EU) No 142/2011 where the following diseases are compulsorily notifiable: African horse sickness, dourine, glanders (Burkholderia mallei ), equine encephalomyelitis (all types including Venezuelan equine encephalomyelitis), equine infectious anaemia, vesicular stomatitis, rabies, anthrax;

II.4. have been derived from blood from equidae, which was collected under the supervision of a veterinarian in slaughterhouses approved in accordance with Regulation (EC) No 853/2004 of the European Parliament and of the Council, in slaughterhouses approved and supervised by the competent authority of the country of collection and in facilities approved and supervised by the competent authority of the country of collection for the purpose of collecting blood from equidae for the production of blood products for purposes other than feeding for farmed animals;

II.5. have been derived from blood which was collected from equidae:

II.5.1. which on inspection on the date of blood collection did not show clinical signs of any of the compulsorily notifiable diseases listed in Annex I to Council Directive 2009/156/EC, and of equine influenza, equine piroplasmosis, equine rhinopneumonitis and equine viral arteritis listed in point 4 of Article 1.2.3 of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE), 2010 edition;

II.5.2. which have been kept for at least 30 days prior to the date of and during blood collection on holdings under veterinary supervision which were not subject to a prohibition order pursuant to Article 4(5) or restrictions for African horse sickness in accordance with Article 5 of Directive 2009/156/EC;

II.5.3. which had no contact with equidae from a holding which was subject to a prohibition order for animal health reasons pursuant to Article 4(5) of Directive 2009/156/EC;

II.5.4. for which the period for the prohibition order referred to in points II.5.2. and II.5.3 has been determined as follows:

  • either [not all the animals of species susceptible to the disease located on the holding have been slaughtered , in which case the period of prohibition must be at least:
    • six months in the case of glanders (Burkholderia mallei ), beginning on the date on which the equidae infected with the disease are slaughtered,
    • six months in the case of equine encephalomyelitis of any type, including Venezuelan equine encephalomyelitis, beginning on the date on which the equidae infected with the disease are slaughtered,
    • in the case of equine infectious anaemia, until the date on which, the infected animals having been slaughtered, and the remaining animals have shown a negative reaction to two Coggins tests carried out three months apart,
    • six months from the date of the last recorded case of vesicular stomatitis,
    • one month from the date of the last recorded case of rabies,
    • 15 days from the date of the last recorded case of anthrax;]
  • or [all the animals of species susceptible to the disease located on the holding have been slaughtered and the premises were disinfected, in which case the period of prohibition must be 30 days, beginning on the date on which the animals were slaughtered and the premises disinfected, except in the case of anthrax, where the period of prohibition shall be 15 days;]

II.6. blood products come from an establishment or plant approved or registered by the competent authority of the third country meeting the specific conditions set out in Article 23 or 24 of Regulation (EC) No 1069/2009;

II.7. blood products have been produced from blood which fulfils the conditions referred in II.4 and II.5 and

  • either [has been collected from equidae which have been kept for a period of at least three months, or since birth if less than three months old, prior to the date of collection on holdings under veterinary supervision in the country of collection which during that period and the period of blood collection has been free of:
    • (a) African horse sickness for two years;
    • (b) Venezuelan equine encephalomyelitis for a period of at least two years;
    • (c) glanders
      • either [for a period of three years;]
      • or [for a period of six months where the animals have passed the post-mortem inspection for glanders in the slaughterhouse referred to in II.4, including a careful examination of mucous membranes from the trachea, larynx, nasal cavities and sinuses and their ramifications, after splitting the head in the median plane and excising the nasal septum;]
    • (d) in the case of blood products other than serum and plasma, vesicular stomatitis for six months;]]
  • or [has been subjected to at least one of the following treatments, followed by an effectiveness check, for the inactivation of possible causative pathogens for African horse sickness, equine encephalomyelitis of all types including Venezuelan equine encephalomyelitis, equine infectious anaemia, vesicular stomatitis and glanders (Burkholderia mallei ):
    • either [heat treatment at a temperature of 65°C for at least three hours;]
    • and/or [irradiation at 25 kGy by gamma rays;]
    • and/or [change in pH to pH 5 for two hours;]
    • and/or [heat treatment of at least 80°C throughout their substance;]]

II.8. all precautions have been taken to avoid contamination of the blood and blood products with pathogenic agents during production, handling and packaging;

II.9. blood and blood products were packed in sealed impermeable containers clearly labelled "NOT FOR HUMAN OR ANIMAL CONSUMPTION" and bearing :

  • (a) in the case of blood, the approval number of the establishment of collection;
  • (b) in the case of blood products, the approval number of the establishment of production;

II.10. the products were stored in enclosed storage.

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