What is the Purpose of EU Legislation Controlling Animal By-Products and Derived Products?
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.
Key points:
- The legislation applies to:
- Animal by-products and derived products which, by law, may not be used for human consumption.
- Animal-origin products which may be used for human consumption but are instead used for other purposes.
- Raw materials used to manufacture animal origin products not intended for human consumption.
- Producers of animal by-products and derived products must ensure they comply with the legislation from the start to the end of the manufacturing chain.
- They must keep a record of the products they dispatch, transport, or receive, along with the required documentation.
- They must inform national authorities of the products and premises they use during the manufacturing chain. The latter must meet certain hygiene standards and require formal approval.
- EU countries operate official checks to ensure producers collect, identify and transport animal by-products without delay and treat, use, or dispose of them according to the rules.
- Animal by-products and derived products are graded in 3 categories depending on the level of health risk they pose to the public or animals. These determine how they should be disposed of or recovered.
- Restrictions exist on the use of animal by-products and derived products. For instance, they may not be used to feed animals or farmed fish of the same species.
- Imports of both types of products must satisfy EU standards.
- A ban exists on the export of both types of products for incineration or landfill, or to countries which are not members of the Organization for Economic Co-operation and Development (OECD) for use in a biogas or composting plant.
- Derived products, such as cosmetics, medical devices, and veterinary medicines, which comply with other pieces of EU legislation, may be offered for sale when they reach the end of the manufacturing chain.
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What Regulations and What is their Focus?
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)
https://eur-https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A02009R1069-20191214
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)
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A02011R0142-20191214
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What Types of Products are Covered by the Legislation?
Most animal by-products or derived products not intended for human consumption are covered by the regulation:
- animal by-products and derived products which are excluded from human consumption under Community legislations; and
- the following products which pursuant to an irreversible decision by an operator, are destined for purposes other than human consumption:
- Products or animal origin which may be destined for human consumption under Community legislation.
- Raw materials for the production of products of animal origin.
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What are Categories?
- Animal by products and derived products covered by this legislation are categorized as Category 1, 2 or 3. Each successive category being assessed as presenting a decreasing risk to animal or human health with Category 1 being of higher perceived risk and Category 3 a lower risk.
- Regulation (EC) No 1069/2009 details the criteria for the categorization of material.
- Information may be found in the ISIA/MedTech Europe Guidance Document.
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What Category is Fetal Bovine Serum?
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.
- As a result, USA FBS is considered category 1
