1069/142 Implementation

EU Flag

EU Legislation

  • 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.

  • 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

  • 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.

    • 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.

  • 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

Traces

EU Agencies and Systems

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

  • TRACES stands for TRAde Control and Expert System.

    TRACES 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 all linked entry procedures and to offer a fully digitized and paperless workflow. It facilitates the exchange of data, information and documents between all involved trading parties and control authorities. The possibility to trace back and forth all the movements contributes to the reduction of the impact of disease outbreaks and allows for a quick response to counter certain 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 European Community and in 3rd countries (there are exceptions - 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; or 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.

How does this Legislation affect me and my Business?

legal

  • If you are handling animal by-products and derived products in a facility located in the European Economic Area (European Union 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) has left the European Union on the 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, the new relationship with the EU includes the Northern Ireland (NI) Protocol. As a result of the protocol, NI has in effect remained in the EU´s single market and 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 the animal by-products and derived 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 3rd 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 to farmed animals or for application to land from which such animals are to be fed, i.e., for any use other than for human or animal consumption. There is no quick and simple answer to this, 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.

    * Repealed and replaced by Regulation (EU) 2017/625

  • 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 codes from the Combined Nomenclature.

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

    If your product is subject to official controls at BCPs following Implementing Regulation (EU) 2021/632 but a model health certificate cannot be found in Annex XV to Regulation (EU) 142/2011, you should contact your local competent authority and the importer for clarification and advice.

  • Carefully and correctly! This is very important since 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 as to 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.

Traceability, Labelling and Packaging

Cow

  • Commission Implementing Regulation (EU) 2021/632 establishes lists of animal by-products and derived products that are subject to official controls at border control posts and indicates their codes from the Combined Nomenclature (CN). To ensure that animal products entering the European Union are safe, and to verify compliance with the applicable requirements (e.g., food and feed and their safety, placing on the market, animal health requirements, etc.), competent authorities perform official controls on consignments subject to official controls upon arrival at the border control post. Those official controls include documentary, identity and physical checks. A consignment of animal products can only enter into the European Union if it has satisfactorily undergone the specific checks. A Common Health Entry Document (CHED) might be issued from TRACES.

  • Combined Nomenclature (CN) established by the European Commission is a goods nomenclature, which meets - at one and the same time - 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.

  • As 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 to.

    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.