For many years there has been confusion in our industry regarding the origin of the serum collected and sold to customers. This confusion regarding the country of collection, the country of manufacture, and the further treatment of serum has contributed to the mis-labeling of serum.
ISIA believes it is vitally important that our industry follow standard defintions when declaring the contents of the product. Our goal is to have all ISIA member companies declare on the label of a product and on the certificate of analysis all countries involved in the collection and processing of FBS.
See below the ISIA recommendations for Serum Origin Definitions.
Origin as defined in the Traceability Policy and the Traceability Audit Checklist: The ISIA defines origin as the country where the animals were slaughtered or, in the case of donor animals, where the blood was collected. This includes animals born and raised in the country of origin, as well as imported animals, and may also include animals imported for immediate slaughter. We recognize that there could be differences between the serum and/or plasma industry definition of origin and standard trade or WTO definitions or rules about origin. In the best interest of the parties in ISIA we propose specific definitions for the origin of slaughterhouse derived materials and donor origin materials. Furthermore, we endorse the clear separation of batches of serum and/or plasma such that two or more origins of serum and/or plasma are not combined, or at least if they are combined then both origins appear on the official certification.
Country of Collection - The country in which the animal was slaughtered and the blood was collected or, in the case of donor animals, of collection only. (If a company is declaring an “Origin” on the label such as “Australian Origin” or “United States Origin” this should only apply to the country in which the blood was collected and/or the animal was slaughtered.)
Country of Manufacture - This is the country in which the product was sterile filtered or clarified. Other acceptable terms include “Manufacturing Origin” or “Processed in”. Note: the ISIA considers filtration to be a substantial transformation since pooled material cannot be unpooled. The term “manufacture” refers to the material, not the packaging.
Further Treatment - Treatments are performed in addition to sterile filtration or clarification such as gamma irradiation or heat inactivation. These can occur before or after sterile filtration and should be listed individually on the CoA or equivalent document. When treatments occur (i.e. before or after filtration) they should also be declared.
Country of Further treatment - The country where the further treatment occurs. It is the recommendation of the ISIA that all member companies declare either on the label of a product or on the certificate of analysis all countries involved in the collection and processing of FBS. This includes any further treatment that is performed on the product.
It is the view of the ISIA that a change of origin for Customs purposes does NOT impact the physical country of origin of a product. The physical origin (Country of Collection) of a product should be the origin reflected on all documentation including labels and Certificates of Analysis/Origin.
It is, however, recognized that in certain circumstances, the Customs Origin of a product may change from one geography to another. A change in Customs origin may occur in the country where the material was last substantially transformed as defined by the regulating body in charge of the import / export of the product. What is considered a “substantial change” will vary among different controlling regulatory agencies. (Some may consider filtration a substantial change and other may not). Customs Origin should NOT be reported on a product label or Certificate of Analysis/Origin.
Customs Origin should only be utilized on import export documentation for the purposes of clearing customs in accordance with the appropriate laws and regulations.