Filled Gelatine Capsules

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. Filled gelatine capsules can be imported if they:

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

b) are accompanied by the appropriate health certificate/private attestation

3. The gelatine 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 Delegated Regulation (EU) 2021/630

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

2. 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

3. Third Country Listing

i) consignments of gelatine must come from a listed third country as per Article 18 of Implementing Regulation (EU) 2021/405

ii) consignments of composite products that do not need to transported or controlled under temperature controlled conditions and which do not contain colostrum-based products or meat products must come from a Third Country listed for entry to the Union of meat products or dairy products or fishery products or egg products.

4. Residues Listing

i) Gelatine is exempt from requirements to be listed in Annex -I of Implementing Regulation (EU) 2021/405 as having an approved control plan for the species or commodities from which the processed products of animal origin contained in the composite products are derived, with the exception of collagen, gelatine and highly refined products of animal origin.

5. If the gelatine capsules are filled with another product of animal origin (e.g. Fish Oil) then they must also be compliant with the relevant requirements for the production of that POAO (e.g. approved establishment, listed third country).

6. If the gelatine capsules are filled with a mixture of processed product of animal origin (PPOAO) and a plant product, then they can be considered a composite product. See page on composite products for third country/approved establishment requirements

7. 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.

1. 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.

2. Gelatine capsules which are derived from ruminant bones must be 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

3. If the gelatine capsules are filled with another product of animal origin (e.g. Fish Oil) then they must also be accompanied by the relevant model health certificate for that POAO

4. If the gelatine capsules are filled with a mixture of processed product of animal origin (PPOAO) and a plant product, then they can be considered a composite product. If they are shelf-stable, and comply with the requirements of Article 22 of Regulation (EU) 2022/2292, then they must be accompanied by a Private Attestation

5. 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. Official controls depend on the contents of the gelatine capsule and are independent of the official certification requirements.

2. If the gelatine capsules contain POAO (e.g. fish oil) then the consignment requires official controls at the BCP (i.e. CHED-P and presentation at the BCP with the relevant official health certificate for the POAO contained).

3. If the gelatine capsule contains PPOAO and plant product (e.g. fish oil and vegetable oil) then this can be considered a composite product and is exempted from official controls at the BCP ( Delegated Regulation (EU) 2021/630).

However if the gelatine is made from ruminant bones then health certificate model GEL must accompany the consignment to the point of placing on the market.

4. If the gelatine capsule contains plant product (e.g. evening primrose oil) then the product can be considered a composite and is exempted from official controls at the BCP (Delegated Regulation (EU) 2021/630). exempted from official controls at the BCP (Delegated Regulation (EU) 2021/630). However if the gelatine is made from ruminant bones then health certificate model GEL must accompany the consignment to the point of placing on the market.

5. If the capsule itself contains gelatine mixed with a plant product (e.g. vegetable oil) which significantly alters the product (e.g. provides a soft texture), and the product is a food supplement, then the capsule can be considered a composite product and the whole product can also be considered a composite product. As such these are exempted from official controls at the BCP (Delegated Regulation (EU) 2021/630).

6. Empty gelatine capsules or empty composite product capsules (gelatine mixed with plant product) are NOT exempted from official controls at the BCP as can not be considered food supplements. If the gelatine contained is derived from ruminant bones then these must be accompanied by a model GEL health cert at the BCP.

Consignments of gelatine capsules entering the EU which require official controls as per the detail above 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.

1. 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.

2. There is a required minimum pre-notification notice period of at least 24 hours’ notice in advance of the consignment’s arrival.

3. Failure to submit correct documentation within this timeline may result in significant delays in the consignment being processed through the Border Control Post

4. 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.

5. 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.