European Union - Chapter 4(D) Blood Products

European Union - Chapter 4(D) Blood Products

Chapter 4(D) Health Certificate for Treated 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.

This certificate is only available from APHIS for blood products from Artiodactyla, Perrissodactyla, Proboscidea, Suidae, Tayassuidae, and avian animals.

Please select the appropriate certificate below based upon the species of origin and treatment method.

Blood products from Artiodactyla, Perrissodactyla, Proboscidea Animals (Includes Ruminants)

       These versions should not be utilized for consignments
       containing only fetal bovine serum and/or the derivatives
       of fetal bovine serum, unless other blood products are
       also included in the production of the certified materials.

Heat treatment (65C for 3 hours)


Irradiation


pH treatment


Heat treatment (80C)


Fetal bovine serum and derivatives of fetal bovine serum

       These versions may be used only for consignments
       containing only fetal bovine serum and/or the derivatives
       of fetal bovine serum.  No other animal origin materials
       may be included in the production of the certified
       materials.


Heat treatment (65C for 3 hours)


Irradiation


pH treatment


Heat treatment (80C)


Blood products from Suidae/Tayassuidae Animals (includes Pigs)

Heat treatment (65C for 3 hours)


Irradiation


Heat treatment (80C)


Blood products from Avian Animals

Heat treatment (65C for 3 hours)


Irradiation


Heat treatment (70C)


Other

The below versions should be utilized when one or more of the following is true. 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. For example, sections II.3-II.4 must be lined out as noted in the above versions in all these cases.

1- Blood products derived from two or more of the following groups of animals are certified on the same 4D certificate:

  • Artiodactyla, Perrissodactyla, Proboscidea Animals (Includes Ruminants);
  • Suidae/Tayassuidae Animals (includes Pigs);
  • Avian Animals

2- Blood products treated in different ways (e.g. some products are processed using heat treatment, and others with irradiation) are certified on the same 4D certificate

3- Consignments only transiting or being stored in the EU

4- Blood products shipped in bulk containers (when the inner most packaging of the blood products is not new or sterilized bags or bottles): In the case of blood products that are shipped in bulk containers, the certificate should be lined out as noted in the versions above, except Section II.8 should be lined out as follows:

II.8.      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;] and

the outer packaging or containers bear labels indicating ‘NOT FOR HUMAN OR ANIMAL CONSUMPTION’;

 

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