Appendix 3 -8 
1 
 Quarantine Requirements for the Importation of Bovine Serum from 
the United States  
(In case of any discrepancy between the English version and the Chinese text of these Requirements, 
the Chinese text shall govern.)  
Promulgated by Council of Agriculture on October 22, 2018 and will enter into force on January  1, 
2019.  
1. For bovine serum from the United States, only that which is manufactured by 
designated serum  processing facilities is eligib le to be imported into Taiwan. In 
addition, only government  agencies, publically operated enterprises, private 
enter prises, academic institutions, and  corporations are permitted to import such 
products. 
 
The list of designated serum processing facilities named in the preceding paragraph must be  provided by the government of the United States, after 
confirming their compliance with Articles  4(4) and 4(5), to the animal quarantine 
authority of Taiwan for approval and publication on its  website.  
2. Bovine serum imported from the United States is prohibited from being used for the production of biological products for ruminants use, or for in- vivo 
tests/research purposes.  
3. The term "disease -free countries (zones)" used in this set of Requirements refers 
to countrie s (zones) recognized by the central competent authority of Taiwan as 
free from foot and mouth  disease and contagious bovine pleuropneumonia.  
4. To import bovine serum from the United States, the following requirements shall be complied  with: 
1) The serum must be  collected from cattle that, at the time of collection, are 
resident in  disease- free countries (zones).  
2) If the serum is collected at slaughter, it must be collected from cattle which 
passed antemortem  inspection and dressed carcasses passed post -mortem 
inspection by the  competent authority of the country where the slaughterhouse 
is located. In addition, prior  to slaughter, the cattle must not be subjected to a 
stunning process with a device injecting  compressed air or gas into the cranial 
cavity nor to a pi thing process.  
3) If the serum is not collected at slaughter, it must be collected from cattle which are found to be clinically healthy by physical evaluation.  
4) The serum must be manufactured in designated serum processing facilities which are located in the U nited States and under the supervision of the 
government of the United States. In addition, appropriate measures must be 
taken to effectively segregate the  serum for export to Taiwan from ineligible Appendix 3 -8 
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 materia ls if these designated facilities also  handle bovi ne blood materials 
which are not compliant with Article 4(1) to 4(3) . 
5) The serum must be filtered through a filter with mesh size 0 .22μM or less, or 
irradiated  with γ-rays at a dosage of 25 kGray (2.5MR.ad) or more. In addition, 
it must be tested  and found free from pathogens of mycoplasma, bovine viral 
diarrhea, infectious bovine  rhinotracheitis and bluetongue.  
6) The serum must be produced, stored and transported in such a manner as to 
prevent  contamination by communicable animal disease pathogens 
transmissible through the  product. 
7) The information presented on the inner package label must include product  
name and lot number.  
8) The government of the United States is required to publish on its website the transportation of bovine serum from the United S tates to Taiwan must meet 
relevant regulations of the International Air Transport Association (IATA).  
5. The bovine serum consignment from the United States must be accompanied by an original  veterinary certificate issued by the animal quarantine authority of  the 
United States. The  certificate must state the following information in its full detail  
in English:  
1) Product name, quantity, and lot number. 
2) Countries (zones) in which the cattle were resident at the time of serum 
collection.  
3) Name and address of the serum processing facilities.  
4) Name and address of the export er. 
5) Destination country, name and address of the import er. 
6) Compliance with Articles 4(1) to 4( 6). 
7) Date and place the certificate was issued, name and official stamp of the issuin g authority, and name and signature of the certifying officer.