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Food Safety

Non-EU countries authorised establishments

Non-EU country establishments database

Lists of food-producing establishments for non-EU countries are proposed by approved (listed) non-EU countries and maintained by the Commission in accordance with the requirements of Article 127 of Regulation (EU) 2017/625 and Article 5 of Commission Delegated Regulation (EU) 2019/625. Lists of establishments for animal by-products are maintained pursuant to Article 30 of Regulation (EU) No 142/2011. With regard to germinal product, and captive birds establishments, these are listed pursuant to Regulation (EU) 2016/429.

Details of the establishments are held in the TRACES platform of the European Commission that is managed and maintained by DG SANTE (TRACES-NT). The accuracy of the information contained in the lists is the responsibility of the non-EU country competent authority. In case of establishments' information that appears to be missing from the published lists, please notify the TRACES Helpdesk (SANTE-TRACES@ec.europa.eu).

Listing of non-EU countries and listing of establishments

Animals and goods derived therefrom can only enter the EU from non-EU countries which are listed. Countries so listed are published on the Commission's website in the following legal acts: Regulation (EU) 2021/404 (animal health), Regulation (EU) 2021/405 (public health) and, if applicable, Commission Decision 2011/163/EU (residues).

Before a non-EU country is listed and can gain access to the EU market for animals and goods, it must apply for listing to the Commission and the application must be evaluated satisfactorily by the Commission. The evaluation involves both a desk-based assessment and, if necessary, an audit carried out by the Health and Food Audits and Analysis Directorate.

It is only when a non-EU country is listed that it may propose establishments for listing. Establishments producing food of animal origin intended for export to the EU must comply with the public health requirements specified in Annex III to Regulation (EC) No 853/2004. Compliance with these requirements must be checked and guaranteed by the competent authorities of the non-EU country before the country can propose that the establishment is listed and appears in the list published by the Commission.

The published lists of establishments are derived from the data in TRACES-NT.

When a non-EU country competent authority identifies that an establishment no longer fulfils the requirements for listing, it must update its lists and remove the establishment.
The competent authority is responsible for keeping the lists of establishments up to date and – via entry of the listing amendment request into TRACES-NT – thereby inform the Commission of any changes.

In the event that non-EU countries experience difficulties in accessing TRACES-NT and/or entering the data into TRACES-NT, guidance is available from the TRACES Helpdesk: SANTE-TRACES@ec.europa.eu.

Updating the lists of establishments

As of 1 December 2021 a new module in TRACES-NT called "Establishment Amendments Lists" replaces the e-mail procedure for establishment listing.

non-EU countries are now responsible for direct entry of their establishment data into TRACES-NT. This entry can only be submitted in TRACES-NT by contact persons ('National Contact Point') who have been designated by the non-EU country competent authority.

The Commission will check if all details are correct and it may request additional information from the non-EU country before the publication of the list. An automatic notification from TRACES-NT will inform the National Contact Point when this takes place.

If the details are not correct, the National Contact Point is informed of the error(s). For example, if the non-EU country is not listed in Regulation (EU) 2021/404 for bovine meat and the National Contact Point wants to include such an establishment in the list uploaded into TRACES-NT, the Commission would return to the competent authority the entire list of establishments for revision. Therefore the onus is on the competent authority to ensure that all submitted data are accurate and relating to establishments for which the required guarantees have been given, in order to expedite publication of the lists.

Regarding fishery vessels (factory vessels, freezer vessels and reefer vessels), a copy of the vessel registration document should be submitted through the TRACES-NT platform as an accompanying document in addition to the establishment details which are entered directly by the National Contact Point. This of course does not apply to land-based fishery product establishments. For this reason non-EU countries are advised to submit separate lists for land-based fishery products establishments and vessels.

Categorisation of the lists of establishments

Annex III to Regulation (EC) No 853/2004 provides a categorisation of food of animal origin in sections. This categorisation is followed for the lists of establishments to the extent possible. An additional 'Section 0' for 'General activity establishments' has been included.

Food:

  • Section 0: 'General activity establishments'
  • Section I: 'Meat of domestic ungulates'
  • Section II: 'Meat from poultry and lagomorphs'
  • Section III: 'Meat of farmed game'
  • Section IV : 'Wild game meat'
  • Section V : 'Minced meat, meat preparations and mechanically separated meat (MSM)'
  • Section VI: 'Meat products'
  • Section VII: 'Live bivalve molluscs'
  • Section VIII: 'Fishery products'
  • Section IX: 'Raw milk, colostrum, dairy products and colostrum-based products'
  • Section X: 'Eggs and egg products'
  • Sections XI: 'Frogs' legs and snails'
  • Section XII: 'Rendered animal fats and greaves'
  • Section XIII: 'Treated stomachs, bladders and intestines: casing only'
  • Section XIV: 'Gelatine'
  • Section XV: 'Collagen'
  • Section XIV/XV: 'Treated raw materials for the production of gelatine and collagen'
  • Section XIV/XVbis: 'Raw materials for the production of gelatine and collagen'

Establishments for animal-by-products are categorised thus:

Article 47 (2)(a) of Regulation (EC) No 1069/2009 provides for the list of establishments, plants and operators in the animal-by-products sector. This list is published in Annex II, Chapter I of the “Technical  Specifications for the Format for the Lists of approved or registered Establishments, Plants or Operators handling Animal By-Products inside the European Union and in Third Countries”.

Animal by-products:

  • Section I: 'Slaughterhouses and fishery vessels'
  • Section II: 'Dairy plants'
  • Section III: 'Other facility for the collection or handling of animal by-products (i.e. unprocessed/untreated materials)'
  • Section IV: 'Processing plants'
  • Section V: 'Petfood plants (Including plants manufacturing dogchews and flavouring innards)'
  • Section VI: 'Game trophies plants'
  • Section VII: 'Plants or establishments manufacturing intermediate products'
  • Section VIII: 'Fertiliser and soil improvers'
  • Section IX: 'Storage of derived products'
  • Section X: 'Blood and blood products, excluding of equidae, for technical purposes other than feed for animals'