Countries of origin

The term “country of origin” can have several meanings and can cause confusion and debate. Origin can refer to the country where the serum was collected, the country where it was processed, or the exporting country. Therefore ESPA prefers to avoid the use of the word “origin” and replace it with more accurate phrases, such as “country of the collection”, “country of processing”, or “exporting country”

When scientists select their sera, the product must come from a company that guarantees the integrity of its supply chain.

Suppliers must be able to guarantee where their products were collected and processed based on an integrated supervision of the collection and manufacturing processes of serum products. 

The countries where the serum was collected and/or processed have no influence on the performance of the serum to support cell growth. One batch of FBS may work well for one specific cell line, but not for another. 

“Serum performance” is specific for each cell line. 

Definition of the country of collection:

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 collection, as well as imported animals, and may also include animals imported for immediate slaughter. 

Definition of the country of processing:

The country where the serum was processed, can include filtration, testing, treatments, bottling, packaging, and labelling.

Definition of misrepresentation

Misrepresentation is when the product is mislabelled in terms of the declared countries of collection and/or processing, in order to get a higher price for the product.  Misrepresentation can be total or partial: 

• “Total” is when all of the misrepresented FBS was collected and/or processed in countries different than the declared countries of collection and/or processing.
• “Partial” is when a portion of the misrepresented FBS was collected and/or processed in countries different than the declared countries of collection and/or processing

Misrepresented “countries of collection and/or processing” generate an illicit profit for the seller, at the expense of the serum users; and may cause companies to unknowingly violate import regulations or product master files. The actual research results and end products are unlikely to be seriously affected, but falsification of the “countries of collection and/or processing” violates government, industry, and consumer standards of honesty and supply chain control. 

“Smuggling” is another method of misrepresentation, and can be in the form of importing a product under a false description; directly to a final destination, or via a third country.