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Collagen

1. The following information pertains to collagen not intended for human consumption.

2. Collagen is defined in, Annex I in Regulation (EU) No. 142/2011, as ‘protein-based products derived from hides, skins, bones and tendons of animals.’

3. The raw materials used in the production of collagen must be sourced from Category 3 materials referred to in Article 10(a), (b), (e), (f), (g), (i) and (j) in Regulation (EC) No. 1069/2009.

4. Collagen 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

1. Collagen may be exported to the EU from Third Countries listed in Part 1 of Annex II to Regulation (EU) No. 206/2010 and the following countries:

i.   South Korea

ii.   Malaysia

iii.  Pakistan

iv.  Taiwan

2. 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 IV)

3. The collagen must have been produced in accordance with Section 8 of Chapter II of Annex X in Regulation (EU) No. 142/2011.

4. The product must have a label indicating “NOT FOR HUMAN CONSUMPTION”.

5. 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. Collagen 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 11 of Annex XV in Regulation (EU) No. 142/2011.

Health Certificate – Collagen (pdf 67Kb)  

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 collagen entering the EU must be inspected at an EU-approved Border Inspection Post (BIP) where Member States' official veterinarians ensure they fulfil all the requirements provided for in the EU legislation.

2. The person responsible for the load being imported (the importer or a customs agent acting on their behalf) must give the BIP 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 Inspection Post.

5. Pre-notification is given by the submission of Part 1 of the Common Veterinary Entry Document (CVED-P), as is laid down in Commission Regulation (EC) No 136/2004, through the online TRACES system.

6. Copies of other supporting documentation associated with the consignment should be submitted at this time as well - such as the Health Certificate, Invoice, Packing list 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, and will be checked and held at the BIP 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 BIP 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 CVED which must accompany the consignment to the first place of destination referred to in the CVED.

5. If the consignment does not meet the import requirements, the consignment may be rejected and either re-exported or destroyed.