FBS Regulatory Framework

Regardless of its origin from North/South America, Australia or New Zealand, all FBS sold in the EU for obvious legal reasons must be “EU approved”. Now, as it is practically zero the quantity of FBS originating in the EU territory itself, when it is said about the FBS to be “EU approved”, it necessarily means that the FBS has been approved for importation into the EU.

Therefore, the regulatory framework that approves the importation of FBS in the EU is the accreditation that every consumer must require to its FBS supplier, because such approval is the only one with legal value for importation.

The Regulations (EU) Nº 142/2011 and Nº 1069/2009 are the legal standard governing the manufacturing and imports of animal by-products not intended for human consumption, of course including the FBS: http://ec.europa.eu/food/animals/animalproducts/other_en

Since Regulation number 142 entered into force in February 2011, the EU authorities have not continued authorizing the imports of animal by-products as before, simply because they originate in third countries free of BSE, FMD, etc., but furthermore they require that it is manufactured in plants approved by the animal health authorities of the third countries in which the plants are located, following the EU standards for plant conditions and manufacturing procedures specified in that Regulation.

As such, in the Annex XV of the Regulation (pages 119 to 248) that refers to “Model Health Certificates”, it is clear that all these models have a space denominated “Place of Origin” to write the “Name”, “Address” and “Approval number” of the plant where the animal by-products are produced. Models of certificates used for FBS appear on pages 168 to 175.

In addition, Regulation 142/2011 orders that the plants ensure the quality of the animal-by products by implementing a System of Hazard Analysis and Critical Control Points (HACCP): http://www.fao.org/docrep/005/Y1579E/y1579e03.htm#bm3

It is not mentioned that the plants must have ISO certifications. However, it explicitly mentions the permanent implementation of a HACCP system directly supervised by the animal health authorities of the third countries (page 249).

Lastly, the Directorate General for Health and Consumers -D.G. SANTE- is the EU authority that issues, in the X section for blood and blood derivates, the approval number of the plants from third countries, classifying whether their activities are Category 3 or low risk, 2 or 1 for higher risks. A plant can have more than one category: https://webgate.ec.europa.eu/sanco/traces/output/non_eu_listsPerCountry_en.htm

These approvals are the only mandatory ones to allow the importation of FBS into the EU, and are issued if and only if the following conditions are given:
1st BSE or any TSE in general do NOT exist in the country of origin.
2nd FMD or other transmissible animal illnesses do NOT exist in the country of origin.
3rd The animal health authority of the country of origin supervises that the plant operates under a permanent HACCP system, for ensuring the quality, traceability and biosecurity.

The Certificates of Suitability, issued by the EDQM which are based only in documentation that verifies the absence of transmissible spongiform encephalopathies (TSE) and good manufacturing practices, are not mandatory documents within the EU as it appears on its webpage: http://www.edqm.eu/en/page_630.php?rubrique=271, however, these are generally used as a good option for marketing purposes in substances used in the preparation of medicinal products.