Blood Products (Excluding horse blood products)
- Foilsithe: 1 Deireadh Fómhair 2019
- An t-eolas is déanaí: 14 Deireadh Fómhair 2020
- General Principles and Relevant Legislation
- Import Conditions
- Veterinary Certification
- Document Submission
- Border Control
General Principles and Relevant Legislation
1. The following information pertains to blood products (excluding from Equidae) for the manufacture of derived products for uses outside the feed chain for farmed animals and not for human consumption.
2. The raw materials used in the production of blood products must be sourced from Category 1 material referred to in Article 8(c) and (d) in Regulation (EC) No 1069/2009 or Category 3 materials referred to in Article 10(a), (b), (d) and (h) in Regulation (EC) No 1069/2009.
3. A blood product can be imported provided that it:
a. Comes from an approved country/part of a country
b. Comes from an approved establishment
c. Is accompanied by and conforms with the requirements of an agreed animal/public health certificate
Import Conditions
1. Untreated blood products from ungulates may be exported to the EU from Third Countries or parts of Third Countries listed in Part 1 of Annex II to Regulation (EU) No. 206/2010.
2. Untreated blood products from poultry and other avian species may be exported to the EU from Third Countries or parts of Third Countries listed in Part 1 of Annex I to Regulation (EC) No. 798/2008.
3. Untreated blood products from species not mentioned in (1) and (2) above may be exported to the EU from Third Countries or parts of Third Countries listed in Part 1 of Annex II to Regulation (EU) No. 206/2010, in Part 1 of Annex I to Regulation (EC) No. 798/2008, or in Part 1 of Annex I to Regulation (EC) No. 119/2009.
4. Treated blood products from any species may be exported to the EU from Third Countries or parts of Third Countries listed in Part 1 of Annex II to Regulation (EU) No. 206/2010, in Part 1 of Annex I to Regulation (EC) No. 798/2008, or in Part 1 of Annex I to Regulation (EC) No. 119/2009.
5. Lists of approved establishments may be found here (Animal by-products: Section III)
6. The blood products must have been produced in accordance with Section 2 of Chapter II of Annex XIV of Regulation (EU) No. 142/2011.
7. The product must have a label indicating “NOT FOR HUMAN CONSUMPTION”.
8. Products derived from bovine, ovine or caprine animals must meet the relevant requirements of Regulation (EC) No. 999/2001, which lays down the rules for the prevention, control and eradication of TSEs.
Veterinary Certification
1. Untreated blood products shall be presented at a Community Border Inspection Post accompanied by a veterinary health certificate, drawn up in conformity with the model certificate found in Chapter 4(C) of Annex XV in Regulation (EU) No. 142/2011.
2. Treated blood products shall be presented at a Community Border Inspection Post accompanied by a veterinary health certificate, drawn up in conformity with the model certificate found in Chapter 4(D) of Annex XV in Regulation (EU) No. 142/2011.
3. The certifying veterinarian should ensure that only the relevant paragraphs and, where appropriate, additional guarantees and/or special conditions applicable to the exporting country are included.
Document Submission
1. Providing all the documentation has been submitted correctly and within the correct timeframes, a large proportion of the documentary check can be commenced in advance of the consignment’s arrival. This includes examination of the veterinary certificate and other documents accompanying a consignment.
a. Please note the original hard copy of the health certificate must travel with the consignment, this will be checked and held at the BCP at the point of entry into the EU.
2. Provided all is in order with the documentary check, the consignment will then be subject to an identity check at the BCP to ensure it identifies with the consignment that was declared in the documentation.
3. A proportion of consignments will be selected for a full physical inspection with/without sampling as appropriate.
4. Upon satisfactory completion of the required checks, the decision is entered in Part 2 of the CHED which must accompany the consignment to the first place of destination referred to in the CHED.
5. If the consignment does not meet the import requirements, the consignment may be rejected and either re-exported or destroyed.
Border Control
1. Consignments of animal by-products entering the EU must be inspected at an EU-approved Border Control Post (BCP) where Member States' official veterinarians ensure they fulfil all the requirements provided for in EU legislation.
2. The operator responsible for the consignment must give the BCP at the intended point of entry advance notification of the arrival of the consignment.
3. There is a required minimum pre-notification notice period of at least 24 hours’ notice in advance of the consignment’s arrival.
4. Failure to submit correct documentation within this timeline may result in significant delays in the consignment being processed through the Border Control Post.
5. Pre-notification is given by the submission of Part 1 of the Common Health Entry Document (CHED-P), as is laid down in Commission Implementing Regulation (EC) No. 2019/1715, through the online TRACES NT system.
6. Other supporting documentation associated with the consignment should be submitted at this time as well - such as the health certificate, invoice, packing list, bill etc.