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.