Animal By-products for the Manufacture of Derived Products for uses Outside the Feed Chain, or for use as Trade Samples

1. The following information pertains to animal by-products for the manufacture derived products for uses outside the feed chain for farmed animals and not for human consumption.

2. Derived products are defined, in Article 3 Regulation (EC) No 1069/2009, as ‘products obtained from one or more treatments, transformations or steps of processing of animal by-products’

3. The raw materials used in the production of the derived products must be sourced from Category 3 materials referred to in Article 10(a) to (m) in Regulation (EC) No 1069/2009.

4. In the case of fur for the manufacture of derived products, only Category 3 materials referred to in Article 10(n) in Regulation (EC) No 1069/2009 may be used.

5. Animal by-products for the manufacture of derived products for uses outside the feed chain can be imported provided that they:

• Come from an approved country/part of a country

• Comes from an approved establishment

• Are accompanied by and conform with the requirements of an agreed animal/public health certificate

1. Animal by-products intended for use in the manufacture of pharmaceuticals may be exported to the EU from 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, and the following third countries:

• Japan

• Philippines

• Taiwan

2. Animal by-products for the manufacture of products for uses outside the feed chain for farmed animals, other than pharmaceuticals may be exported to the EU from Third Countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010 from which imports of fresh meat of the respective species is authorised, in Part 1 of Annex I to Regulation (EC) No 798/2008, in Part 1 of Annex I to Regulation (EC) No 119/2009, or, in the case of material from fish, third countries listed in Annex II to Decision 2006/766/EC.

3. The products must have been prepared and stored in a plant, approved, validated and supervised by the competent authority in accordance with Article 24 of Regulation (EC) No. 1069/2009.

• Lists of approved establishments may be found here (Animal by-products: Section I and III)

4. The products shall comply with the requirements set out in Section 8 in Chapter II of Annex XIV in Regulation (EU) No. 142/2011.

5. Animal by-products to be used for purposes outside the feed chain or for trade samples must have a label indicating ‘’ANIMAL BY-PRODUCTS ONLY FOR THE MANUFACTURE OF DERIVED PRODUCTS FOR USES OUTSIDE THE FEED CHAIN’’.

6. Animal by-products for the manufacture of petfood must have a label indicating ‘‘RAW MATERIAL ONLY FOR THE MANUFACTURE OF PET FOOD’’

7. 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.

1. Animal by-products for the manufacture of products for uses outside the feed chain for farmed animals 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 8 of Annex XV in Regulation (EU) No. 142/2011.

• Health Certificate - Animal by-products (outside feed chain for farmed animals) (pdf 75Kb)

2. 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

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.

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.