EU legislation seeks to lay down public health and animal health rules for animal by-products and derived products. These rules are designed to prevent and minimize risks to human and animal health, and to ensure the food and feed chain is kept safe.
Regulation (EC) 1069/2009 and Commission Regulation (EU) 142/2011 replaced the (Regulation (EC) 1774/2002) and are a consolidation of several related and revised acts. “Consolidated” means that the basic EU legislation, its amendments, and corrections all figure in a single document.
Regulation (EC) No 1069/2009 is the basic outline regulation covering the import of animal derived material not for human or animal consumption and Regulation (EU) No 142/2011 is the document providing the implementing rules. Together these documents address both animal by-products and animal derived products and cover all aspects of the collection, processing, and transport of these materials both into and within the European Community.
Here are the official titles and descriptions of these regulations together with links to the consolidated version:
Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, pp. 1-33)
Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, pp. 1-254)
Most animal by-products or derived products not intended for human consumption are covered by the regulation:
Fetal Bovine Serum (FBS) is to be considered as Category 3 material if it was derived from blood of animals which did not show any signs of disease communicable through blood to humans or animals obtained from animals that have been slaughtered in a slaughterhouse after having been considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with Community legislation.
DG SANTE has stated: The fetal bovine blood harvested from fetuses, which have been obtained from bovine animals slaughtered in the slaughterhouse should be Category 3 material. If the fetus is aborted as a result of a particular disease or stillborn that material should be considered Category 2 material.
FBS derived from blood from animals which have been submitted to illegal treatment (substances as defined in Directives 96/22/EC or 96/23/EC*) or containing residues of other substances and environmental contaminants (as defined in Directive 96/23/EC*) exceeding the permitted level laid down by Community legislation or national legislation, is to be considered as Category 1 material.