Regardless of whether its origin is North or South America, Australia, or New Zealand, all FBS sold within the EU must, for obvious legal reasons, be “EU Approved.” Since the amount of FBS originating from EU territory is practically zero, when an FBS is described as “EU Approved,” it necessarily means that it has been authorized for import into the EU.
Therefore, the legal framework governing FBS imports into the EU is the accreditation that every customer should require from their FBS supplier, as this import approval is the only one with legal validity.
Regulations (EU) No. 142/2011 and No. 1069/2009 establish the legal standards for the manufacture and import of animal by-products not intended for human consumption, which of course includes FBS:
https://ec.europa.eu/food/food/biosafety/animalbyproducts/index_en.htm
Since Regulation No. 142 entered into force in February 2011, EU authorities have no longer authorized imports of animal by-products simply because they originate from countries free of BSE, foot-and-mouth disease, etc. They now additionally require that these products be manufactured in facilities approved by the animal health authority of the third country where they are located, and that these facilities comply with EU standards for plant conditions and manufacturing procedures as specified in the Regulation.
For this reason, Annex XV of the Regulation (pages 119 to 248), which refers to “Models of Health Certificates,” clearly includes a section called “Place of Origin” to indicate the “Name,” “Address,” and “Authorization Number” of the facility where the animal by-products were produced. The certificate models used for FBS appear on pages 168 to 175.
Additionally, Regulation 142/2011 requires that facilities ensure the quality of animal by-products by implementing a HACCP system:
http://www.fao.org/DOCREP/005/Y1579S/y1579s03.htm#bm3
It is worth noting that the Regulation does not mention ISO certifications; instead, it explicitly requires the permanent implementation of a HACCP system, directly supervised by the animal health authority of the third country (page 249).
Finally, the Directorate-General for Health and Food Safety (DG SANTE) is the EU authority that issues, in Section X for Blood and Blood Derivatives, the approval numbers for facilities in third countries, classifying their activities into Category 3 (lower risk), 2, and 1 (higher risk). A single facility may hold more than one category:
https://webgate.ec.europa.eu/sanco/traces/output/non_eu_listsPerCountry_es.htm
These approvals are the only legally mandatory requirement for allowing FBS imports into the EU and are granted when the following conditions are met:
- The country of origin is free of BSE and, in general, all transmissible spongiform encephalopathies (TSEs).
- The country of origin is free of foot-and-mouth disease and other high-risk transmissible diseases.
- The animal health authority of the country of origin supervises that the facility operates permanently under a HACCP system to ensure quality, traceability, and biosafety.
It is also important to explain that Certificates of Suitability issued by the EDQM are based on documentation proving the absence of transmissible spongiform encephalopathies (TSEs) and compliance with Good Manufacturing Practices (GMPs). This aligns with DG SANTE requirements for approving imports from facilities located in countries free of these diseases and operating under a HACCP system. These certificates are generally used for marketing substances intended for the preparation of medicinal products.