EU export approval for food plants

1. Confirm market access for your products

Country approval applies to specific product categories and can include restrictions. Approval to export one type of food of animal origin does not cover all of them. Implementing Regulation (EU) 2021/405 sets the country lists for public health and hygiene, and Implementing Regulation (EU) 2021/404 sets the animal health conditions.

Check the entry for your country and product category, including any restrictions, in these sources.

• Implementing Regulation (EU) 2021/405, country lists for public health and hygiene
• The European Commission’s overview of listed countries and establishments

Use the current consolidated text, since the lists are amended. The country must be approved for the category before the authority can propose establishments for listing. The products and production activities should therefore be clarified before the scope of a conversion or a new plant is set.

2. Check the requirements for the country's control plan

For product categories that require an approved control plan, the country must meet these conditions in addition to the other conditions for market access. The plan covers pharmacologically active substances, pesticides and contaminants, and the requirements and exemptions depend on the product category. The conditions are set out in Delegated Regulation (EU) 2022/2292, and the country entries in Implementing Regulation (EU) 2021/405.

The control plan is a national precondition. The technical standard and the hygienic operation of the plant are assessed in addition.

3. Agree the basis for the application with the food authority

The competent food authority in the country of production must inspect the plant and guarantee that it meets the requirements before it proposes the plant for the EU list. The authority is also responsible for keeping the information on the list correct and up to date, as the European Commission describes.

The company should agree these points with the authority.

• which products and production activities the application is to cover
• which documentation the authority requires
• how the inspection and any sampling will be carried out
• how necessary improvements are to be documented

The documentation is set by each authority. The Commission’s guidance describes the authority’s responsibility and leaves the content of the application to the authority.

4. Assess building, equipment and operation against the requirements

Two regulations are central. Regulation (EC) No 852/2004 sets the general hygiene requirements for premises, equipment and operation. Annex II covers cleanability, ventilation, water supply, waste, personal hygiene and protection against contamination. Article 5 requires permanent procedures based on the HACCP principles.

Regulation (EC) No 853/2004 adds specific requirements for food of animal origin. The requirements in Annex III vary between product categories and production activities.

Meat and meat products. The regulation distinguishes between slaughterhouses, cutting plants, plants for minced meat and meat preparations, and plants for meat products. The specific requirements include separation of operations, facilities for meat inspection, requirements for raw material and temperature control. They also differ between domestic ungulates, poultry and game. Annex III, Sections I to VI.

Fish and fishery products. The specific requirements cover hygienic handling and processing, chilling, freezing and storage. Certain products are also subject to requirements for parasite treatment and for control of histamine and toxins. Annex III, Section VIII.

Milk and dairy products. The requirements cover the origin and quality of raw milk, hygiene during milking and collection, temperature control and conditions for heat treatment. The regulation also sets criteria for plate count and residues of antibiotics. Annex III, Section IX.

Eggs and egg products. Eggs must be protected and stored under suitable conditions. Egg product plants must keep the washing, drying and breaking of eggs separate from other operations, and the treatment must reduce microbiological hazards and prevent contamination after treatment. Annex III, Section X.

Other food of animal origin. Live bivalve molluscs, frogs’ legs and snails, rendered animal fats, treated stomachs, bladders and intestines, gelatine, collagen and certain highly refined products have their own provisions. They cover the origin of the raw material, production areas, treatment and the finished product. Annex III, Sections VII and XI to XVI.

What the general hygiene requirements mean for the building

Layout and working space. The premises must give enough room for hygienic operations and allow cleaning and maintenance. The layout must protect food against contamination between and during operations.

Floors, walls and ceilings. Surfaces must meet the requirements for cleaning and, where necessary, disinfection. Ceilings and overhead fixtures must limit the build-up of dirt, condensation and the shedding of particles.

Drainage and ventilation. Drainage must be designed so that it creates no risk of contamination. Mechanical airflow from a contaminated area to a clean area must be avoided, and the ventilation system must give access to parts that need cleaning or replacement.

Staff facilities and storage. The requirements cover hand washing, toilets and changing rooms. Where products need temperature control, the premises must have enough capacity to handle and store them at the right temperatures.

The general requirements for premises are in Annex II of Regulation (EC) No 852/2004.

The building and HACCP are planned together

The HACCP procedures identify hazards, set the critical control points and describe critical limits, monitoring, corrective action and verification. Documents and records are adapted to the nature and size of the business, as Article 5 of Regulation (EC) No 852/2004 requires.

The office uses the production process and the hazard analysis as the starting point for the design. Together they show which activities need separation, which movements must be controlled and where existing solutions must be adapted. For management, the assessment results in a clear basis for decision. It covers the building work required, how it affects production and how it fits the company’s plans for capacity and growth.

5. The authority inspects the plant and proposes it for listing

The authority must inspect the plant and be able to guarantee that the requirements are met before it proposes the plant for the EU list. The information is handled in TRACES NT. The Commission checks the information and can ask for more before the list is published, as the European Commission describes. The published lists are in the TRACES NT register of establishments.

Listing is a condition for export from establishments covered by this requirement. Each consignment must also meet the relevant import conditions, including official certification where it applies, under Delegated Regulation (EU) 2022/2292.

6. Maintain the requirements after listing

Assessment of an existing plant

The office helps the company clarify which building changes the plant needs, develops the solutions and designs the conversion or the new plant. The work starts from the production and the hygiene requirements that apply to the products.

In an existing plant, the office reviews the layout, production flow, hygienic zones and building solutions against the requirements for the planned production. The review covers these points.

• how raw material, product, packaging, staff and waste move through the plant
• where activities and areas need separation
• surfaces, joints and access for cleaning and maintenance
• the position of floor drains, drainage and transitions between hygienic zones
• changing rooms, goods reception, storage and space for production

Management gets a concrete picture of what can be kept, what must change and how the measures affect the use of the plant.

Proposals and a basis for decision

Based on the assessment, the office develops proposals for a conversion, an extension or a new plant. The proposals show how the necessary changes fit the production flow, the capacity and the plans for further development.

Where several solutions are possible, the alternatives are compared on use of area, production flow, construction and room for later extension. The company can then choose a direction before detailed design.

Design of the measures

The office prepares drawings and specifications for the chosen solutions. The work covers layout, hygienic zones, materials and building details, and the integration of ventilation, changing rooms, storage and goods reception. The drawings make the building solutions clear to the company, the other project participants and the authority that will assess the plant.

The client sets the hygiene standard and the guidelines the plant is to follow before design begins. The office is a member of EHEDG and is listed among the EHEDG members as Thommesen Arkitekter. EHEDG Doc. 44, the guideline for food factories, links hygienic design to Chapters I, II, V, VI, VII and IX of Annex II to Regulation (EC) No 852/2004.

Start with your production