European Union: Untreated Blood Products - Chapter 4(C)

Last Modified: April 12, 2024
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Chapter 4(C) Health Certificate for Untreated Blood Products (from Animals other than Equidae) For Technical Purposes

Advisory regarding commercial documents e.g. company certificates of origin or analysis.

The EU has indicated that consignments of blood products will be rejected if accompanied by commercial documents containing more specific information than the below certificates.  APHIS strongly recommends that exporters not include commercial documents (or other paper work) with the consignments that make any claims regarding the origin of the blood products or about other information addressed in these certificates.  The pre-lined out versions below contain the most specific assurances APHIS can provide for these consignments.

Please select the appropriate certificate below based upon the species of origin of the blood product.

Options I though II.6 below are for materials exported in new or sterilized bags or bottles.

  1. Blood Products Derived from Avian Animals
    1. From areas other than HPAI Banned Areas or ND Banned Areas:
    2. Untreated blood products from HPAI Banned Areas or ND Banned Areas are not eligible for export to the EU at this time.
       
  2. Blood Products Derived from Bovine, Ovine, and/or Caprine Animals
    1. Other than fetal bovine serum (FBS) and derivatives: The following certificate is for products derived from bovine, ovine, and/or caprine animals-except for fetal bovine
      serum (FBS):
      • Dispatch to EU - April 2019
      • This version may also be utilized for products containing both blood products derived from bovine/ovine/caprine animals and also blood products derived from
        ruminants other than bovine/ovine/caprine animals (e.g. if a shipment had a product containing both bovine blood and also deer blood).
    2. Fetal bovine serum (FBS) and derivatives: The following version may be used only for consignments containing only fetal bovine serum and/or derivatives of fetal
      bovine serum. No other animal origin materials may be included in the production of certified materials.
  3. Blood Products Derived from Ruminants other than Bovine, Ovine, and/or Caprine Animals
  4. Blood Products Derived from Artiodactyla, Perrissodactyla, and/or Proboscidea Animals Other than Ruminants
  5. Blood Products Derived from Suidae/Tayassuidae Animals (includes Pigs)
  6. Blood products from Livestock OTHER THAN Artiodactyla, Perrissodactyla, Proboscidea, Suidae/Tayassuidae or Avian Animals that are collected in full or in part during FSIS slaughter inspection
  7. Blood products from Laboratory Animals (e.g. rodents) OTHER THAN Artiodactyla, Perrissodactyla, Proboscidea, Suidae/Tayassuidae, or Avian Animals [Not including derivatives of blood from livestock, e.g. rabbits, if collected during FSIS slaughter inspection]
  8. Other
    • The below versions should be utilized when:
      • Blood products are shipped in bulk containers rather than new or sterilized bags or bottles; and/or
      • Blood products derived from two or more of the following groups of animals are certified on the same 4C certificate:
        • Artiodactyla, Perrissodactyla, Proboscidea Animals (includes Ruminants);
        • Suidae/Tayassuidae Animals (includes Pigs)
        • Avian Animals
      • To utilize these versions, the inappropriate text must be lined out prior to endorsement. The text must be lined-out consistent with the pertinent versions above.
      • The only exception is the following one for blood products that are shipped in bulk containers. In the case of blood products that are shipped in bulk containers, Section II.7 should be lined out as follows:
        • II.7. the products were:
          (2)either [packed in new or sterilised bags or bottles,]
          (2)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';