List of non-EU country establishments – explained

Update

Overview of the rules on listing food businesses (“establishments”) for the export of animals and animal products to the European Union (EU).

Background

To ensure that animal products are safe, the EU only imports these foods from approved operators in countries that are allowed to export animal products to the EU (see Third country lists for animal health – explained; Third country lists for public health – explained; EU official health certificates for exports to the EU – explained). Throughout the supply chain, these operators are known as “establishments” – that is, any unit of a food business (Regulation 852/2004, Art. 2(c)).

An establishment can only be approved if the competent authority in the non-EU exporting country has determined that it meets EU requirements, and has listed it on the TRACES Establishment Lists webpage.

Impacted Products

Animals, animal products, animal by-products, meat, fish, dairy, fats/oils, honey, sprouts

Overview

Types of establishment

For animal products imported to the EU from non-EU countries, establishments must be approved:

• where animals are kept after primary production (Regulation 2020/692, Art. 8)
• where animal products are prepared (Regulation 2022/2292, Art. 13)
• where products are dispatched from, if the establishment does more than just logistics, e.g. temperature control (Regulation 2022/2292, Art. 13)
• for fisheries: on-land establishments, factories, or freezer vessels, cold-stores or reefer vessels (Regulation 2022/2292, Arts. 18 and 19).

Once the approval procedure is completed, the competent authority assigns the operator a unique approval number.

Products

Establishments must be approved if they are exporting the following agri-food products (Harmonised System, HS codes):

• Animal products under HS chapters meat (2), fish (3), dairy (4), other animal origin (5), fats/oils (15), prepared meat/fish (16).
• Animal products under specific headings:
  • other sugars (1702)
  • chocolate (1806)
  • coffee/tea extracts (2101)
  • ice cream (2105)
  • protein concentrates (2106)
  • non-alcoholic beverages (2202 99)
  • meat flours, meals (2301).
• Sprouts (0704 90, 0706 90, 0708 10, 0708 20, 0708 90, 1214 90) (see Regulation 2658/87).
• Honey (0409, 0410, 1212, 1521, 1702) (see Mandatory listing of establishments exporting honey, and clarifications on animal products).

Products containing substances of animal origin under the following Combined Nomenclature (CN) codes, often not destined for food use, must also only be exported by approved establishments:

• 2202 99, 2932, 3001, 3002, 3501, 3502, 3503, 3504, 3917 10 10, 4101, 4102, 4103.

For further details on which establishments must be approved in relation to each animal species, see Table 1.

Approval by the competent authority

To secure approval, before an establishment can start activities, the competent authority must control its compliance with the EU rules on-site.

This differs significantly from establishments supplying non-risk foods (products not of animal origin and shelf-stable composite products); or carrying out only primary activities (primary production including products of the soil, stock farming, hunting, and fishing, Regulation 852/2004); or transport or storage without temperature control – these establishments can begin activity as soon as they are registered, and only undergo controls at a later stage.

For live animals, detailed requirements to be fulfilled by the establishment are given in Regulation 2019/2035.

The approval number of the establishment must be indicated in the official health certificates accompanying exported food, and must be signed by the competent authority of the non-EU exporting country (see EU official health certificates for exports to the EU – explained).

Procedure for EU listing

Non-EU competent authorities can list approved establishments via the TRACES Establishment Lists webpage.

The European Commission will then check if all details are correct before publishing the list. Where mistakes are noted, the competent authority will be asked to review its whole list of establishments. National contact points in non-EU countries are responsible for updating the Establishment Lists.

See Non-EU countries authorised establishments.

What are the major implications for exporting countries?

The EU rules give significant powers to non-EU competent authorities to approve and control the establishments that are allowed to export to the EU. Every change in approved establishments must be communicated to the European Commission services.

Resources

Online resources from the European Commission:

• Guidance document on the implementation of certain provisions of Regulation (EC) No 853/2004 on the hygiene of food of animal origin
• IMSOC Establishment Lists
• Non-EU countries authorised establishments

PAFF Committee (2021) 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

AGRINFO Webinar and FAQ: Using TRACES

Sources

Tables & Figures

Sources: Live animals, Regulation 2016/429, Art. 94; Animal products, Guidance document on […] the hygiene of food of animal origin, and Regulation 2022/2292, Annex IV and Art. 13; Animal by-products, PAFF Committee (2021), Annex II, Ch. I.