1069/142 Implementation

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 Regulation (EC) No 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.
• 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:
  • Restrictions exist on the use of animal by-products and derived products.
  • 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 non-OECD countries for use in a biogas or composting plant.
• Derived products such as cosmetics, medical devices, and veterinary medicines which comply with other EU legislation may be offered for sale when they reach the end of the manufacturing chain.

Regulation (EC) No 1069/2009 is the basic outline regulation covering the import of animal derived material not for human or animal consumption. Regulation (EU) No 142/2011 provides the implementing rules. Together these documents address both animal by-products and animal derived products and cover all aspects of collection, processing, and transport into and within the European Community.

Regulation (EC) No 1069/2009 — laying down health rules as regards animal by-products and derived products not intended for human consumption (OJ L 300, 14.11.2009, pp. 1–33):
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32009R1069

Commission Regulation (EU) No 142/2011 — implementing Regulation (EC) No 1069/2009 (OJ L 54, 26.2.2011, pp. 1–254):
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A02011R0142-20191214

Most animal by-products or derived products not intended for human consumption are covered by the regulation, including:

• Animal by-products and derived products which are excluded from human consumption under Community legislation.
• Products of animal origin which may be destined for human consumption under Community legislation, but pursuant to an irreversible decision by an operator, are destined for other purposes.
• Raw materials for the production of products of animal origin.

Animal by-products and derived products covered by this legislation are categorized as Category 1, 2, or 3. Each successive category presents a decreasing risk to animal or human health — 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. Additional information may be found in the ISIA/MedTech Europe Guidance Document.

Fetal Bovine Serum (FBS) is to be considered 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 slaughtered in a slaughterhouse after being 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 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 that have been submitted to illegal treatment, or containing residues of other substances and environmental contaminants exceeding permitted levels, is to be considered Category 1 material.

As a result, USA FBS is considered Category 1.

DG SANTE is the acronym for the Commission's Directorate-General for Health and Food Safety. It is responsible for EU policy on food safety and health and for monitoring the implementation of related laws.

The EU Commission is organized into policy departments known as Directorates-General (DGs). DGs develop, implement, and manage EU policy, law, and funding programs. The Commission is steered by a group of 27 Commissioners known as "the college" who together take decisions on the Commission's political and strategic direction.

TRACES stands for TRAde Control and Expert System. It is the European Commission's online platform for sanitary and phytosanitary certification required for the importation of animals, animal products, food and feed of non-animal origin and plants into the European Union, and the intra-EU trade and EU exports of animals and certain animal products.

The main objective of TRACES is to streamline the certification process and offer a fully digitized, paperless workflow. It facilitates the exchange of data, information, and documents between all involved trading parties and control authorities. The traceability functionality allows for quick response to counter serious risks along the agri-food chain.

Animal derived products entering the European Community must come from — and go to — establishments which are listed in TRACES, both in the EC and in third countries (exceptions apply — see Guidance Document).

"Sections" refers to the activities a facility is approved or registered for and listed in TRACES. These include:

• Slaughterhouses
• Dairy plants
• Other facilities for the collection or handling of animal by-products
• Processing plants
• Plants manufacturing intermediate products
• Establishments or plants for the storage of derived products
• Blood and blood products, excluding of equidae, for technical purposes other than feed for animals

If you are unsure under which section your facility should be listed, please contact your local competent authority. For more details, refer to the ISIA/MedTech Europe Guidance Document.

If you are handling animal by-products and derived products in a facility located in the European Economic Area (EU member states + Iceland, Liechtenstein, and Norway) or Switzerland, or supply such materials to someone who then imports into these countries, you will almost certainly be impacted by these regulations.

Note: The United Kingdom (UK) left the European Union on 31 January 2020. Since 1 January 2021, trade requirements have changed and businesses in Great Britain (England, Scotland, Wales) must comply with the new arrangements. However, Northern Ireland (NI) has in effect remained in the EU's single market under the NI Protocol — European ABP legislation still applies to businesses in NI.

If an establishment handles, stores, or processes animal by-products and derived products in the European Union, or those products are intended for export to the European Community, establishments need to be approved or registered by the competent authority of the member state or third country where the establishment is located.

Care must be taken to ensure that the facility is listed in the appropriate section(s) under TRACES.

We suggest that initial contact should be through your local competent authority for the appropriate application forms and advice.

Technical use means not intended for use for the feeding of farmed animals or for application to land from which such animals are to be fed — i.e., for any use other than human or animal consumption. There is no quick and simple answer, but general requirements include:

• Needing to source from a facility registered in TRACES.
• Being registered yourself, which means complying with a variety of sanitary and administrative requirements.

Detailed information may be found in the ISIA/MedTech Europe Guidance Document.

Commission Implementing Regulation (EU) 2021/632 establishes the lists of animal by-products and derived products that are subject to official controls at border control posts (BCPs) and indicates their Combined Nomenclature codes.

Model health certificates for importation from third countries and transit through the EU can be found in Annex XV to Regulation (EU) 142/2011.

If your product is subject to official controls at BCPs but a model health certificate cannot be found in Annex XV, you should contact your local competent authority and the importer for clarification and advice.

Carefully and correctly — minor errors may result in a shipment being rejected. Your local competent authority or border control post (BCP) of entry into the European Community will be able to offer advice on the paperwork required. This is important since there is still local interpretation as to current requirements. The ISIA/MedTech Europe Guidance Document gives much additional information on this subject.

Commission Implementing Regulation (EU) 2021/632 establishes lists of animal by-products and derived products subject to official controls at border control posts.

To ensure animal products entering the EU are safe and to verify compliance with applicable requirements, competent authorities perform official controls on consignments upon arrival at the border control post. Those controls include documentary, identity, and physical checks. A consignment can only enter the EU if it has satisfactorily undergone these checks. A Common Health Entry Document (CHED) may be issued from TRACES.

The Combined Nomenclature (CN) established by the European Commission is a goods nomenclature that meets the requirements of the Common Customs Tariff, the external trade statistics of the Community, and other Community policies concerning the importation or exportation of goods.

CN codes serve as an indicator to customs and veterinary officials as to whether a consignment requires veterinary inspection.

Traceability is the paper trail that establishes the provenance of a product. This covers movement from the establishment of origin all the way to the final facility within — or for goods in transit, outside of — the European Community until the material is ready to be placed on the market.

At any point in the supply chain, the establishment having control of the product must be able to satisfy an audit to demonstrate the ultimate origin(s) of the material in an unbroken chain.

Operators consigning, transporting, or receiving animal by-products or derived products shall keep a record of consignments and related commercial documents or health certificates.

From the starting point in the manufacturing chain, animal by-products and derived products within the scope of these regulations must be collected and transported in sealed new packaging or covered leak-proof containers or vehicles.

The health certificate under which the material is imported may specify certain packaging requirements which manufacturers and importers must comply with. The ISIA/MedTech Europe Guidance Document gives additional information on packaging.

Yes. Depending upon the category, processing, and final use of the material, there are various labelling requirements (e.g., colour coding and specific wording) that must be met. Full details of these requirements are given in the relevant section of the ISIA/MedTech Europe Guidance Document.