Products of Animal Origin for Human Consumption: Gelatine and Collagen

1. Gelatine is defined, in Annex I of Regulation (EC) No. 853/2004, as natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals.

2. Collagen is defined as the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with the relevant requirements laid down in Regulation (EC) No 853/2004.

3. Gelatine and collagen can be imported provided that it:

a) comes from an approved country/part of a country

b) comes from an EU approved establishment

c) is accompanied by an agreed animal/public health certificate

4. The gelatine and collagen must have been produced in accordance with the conditions laid down in:

a) Commission Regulation (EU) 2016/429 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption

b) Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

c) Regulation (EC) No 852/2004 on the hygiene of foodstuffs

d) Regulation (EC) No 853/2004 laying down specific rules for food of animal origin

e) Regulation (EU) 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products

f) Commission Delegated Regulation (EU) 2022/2292 supplementing Regulation (EU) 2017/625 with regard to requirements for the entry into the Union of consignments of certain animals and goods intended for human consumption

1. The requirements for the import of gelatine and collagen from third countries into the EU are provided in Commission Delegated Regulation (EU) 2022/2292.

2. The list of approved Third Countries from which gelatine and collagen may be imported is contained in Commission Implementing Regulation (EU) 2021/405;

Gelatine and collagen derived from bovine, ovine, caprine, porcine and soliped (inc Equidae) – Annex XII

Gelatine and collagen derived from poultry – Annex XIII

Gelatine and collagen derived from fishery products – Annex IX

Gelatine and collagen derived from Leporidae – Annex V

Gelatine and collagen derived from wild land mammals other than ungulates and Leporidae – Annex VI

3. Gelatin and collagen must be produced in establishments approved to export to the EU.

4. List available at: Non-EU countries authorised establishments (europa.eu.

5. Products derived from bovine, ovine and 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. Commission Decision 2007/453/EC categorises countries according to their BSE risk.

6. In accordance with Regulation (EC) No’s 853/2004 and 854/2004 (as amended), products of animal origin must bear an identification mark that shows the approval number of the approved premises together with an abbreviation for the country of origin, the name of the product and a date of minimum durability. The mark must be applied directly to the product or to the wrapping or packaging.

7. Iceland, Norway, Switzerland and Liechtenstein have international agreements with the EU which means that they implement EU veterinary legislation in relation to the movement of animal products. Animal products from these countries must comply with the same requirements applying to animal products from EU Member States and are therefore not subject to veterinary checks.

1. Gelatine shall be presented at a Border Control Post accompanied by a veterinary health certificate, drawn up in conformity with the Model GEL drawn up in accordance with the model set out in Chapter 41 of Annex III of Regulation (EU) 2020/2235

2. Collagen shall be presented at a Border Control Post accompanied by a veterinary health certificate, drawn up in conformity with the Model COL drawn up in accordance with the model set out in Chapter 42 of Annex III of Regulation (EU) 2020/2235

3. Raw materials for the production of gelatine and collagen shall be presented at a Border Control Post accompanied by a veterinary health certificate, drawn up in conformity with the Model RCG drawn up in accordance with the model set out in Chapter 43 of Annex III of Regulation (EU) 2020/2235

4. Treated raw materials for the production of gelatine and collagen shall be presented at a Border Control Post accompanied by a veterinary health certificate, drawn up in conformity with the model TCG drawn up in accordance with the model set out in Chapter 43 of Annex III of Regulation (EU) 2020/2235.

5. The certifying veterinarian should ensure that only the relevant paragraphs and, where appropriate, additional guarantees and/or special conditions applicable to exporting country are included.

6. DAM strive to provide the most up to date version of the relevant EHCs, however legislation updates do take place so TRACES should always be consulted to check for the most up to date version.

1. Regulation (EU) 2022/2292 provides the import requirements for consignments of gelatine capsules.

a) gelatine capsules referred to by HS headings 3913, 3926 or 9602 of Part Two of Annex I to Regulation (EEC) No 2658/87 do not need to come from an approved establishment

b) No official certificate is necessary for the entry into the Union of gelatine capsules covered by HS headings 3913, 3926 or 9602 of Part Two of Annex I to Regulation (EEC) No 2658/87, where those capsules are not derived from ruminant bones

c) Where the gelatine is derived from ruminant bones, the gelatine capsules must be accompanied by health certificate Model GEL drawn up in accordance with the model set out in Chapter 41 of Annex III of Regulation (EU) 2020/2235

2. More detailed requirements for filled gelatine capsules can be found under the separate page ‘Gelatine Capsules’

1. Consignments of gelatine and collagen 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 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 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 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 and so on.

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 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.