Official Controls Regulation - explained

Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 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, [amending and repealing listed Regulations] (Official Controls Regulation)

Update

The Official Controls Regulation, adopted in 2017, entered into application on 14 December 2019. The Regulation lays down updated, simplified and more efficient rules for official controls of food and feed law, rules on animal health and welfare, plant health and plant protection products (PPPs).

Background

The Official Controls Regulation (EU 2017/625) is one of the umbrella acts of the EU legislative framework for food production, along with the General Food Law (EC 178/2002), the Animal Health Law (EU 2016/429) and the Plant Health Law (EU 2016/2031).

It is part of the EU’s "One Health" approach, which considers that human, animal and plant health are interlinked and can have significant impacts on society. It takes an overarching approach across sectors, where official controls cover all of public health, animal health and welfare, plant health, etc.

Third country authorities ensure that the relevant EU legislation is respected by signing the official certificates or attestations that need to accompany consignments exported to the EU (see EU official health certificates for exports to the EU.

What is changing?

The EU has reviewed its framework Regulation for official controls concerning both production within the EU, and products exported to the EU.

It includes three levels:

official controls of the conditions allowing exports from third countries to the EU
controls of produce entering the EU
controls by the Commission of correct application of the Regulation, both by EU Member States and in third countries.

The Regulation is mainly addressed to competent authorities in charge of official controls.

Now all official controls, including for plant health, plant protection products (PPPs) and animal by-products, are included in a single Regulation.

The scope (Art. 1) covers all food and feed, at any stage of production, processing and distribution, from any angle (including safety, integrity, fair practices in trade, labelling, animal and plant health, by-products and derived products, animal welfare, organic, GMOs, protected geographical indications and traditional specialities guaranteed).

The Regulation builds on a risk-based approach, and on early detection and prevention.

It takes a stronger stance on supporting animal welfare, controlling e-commerce and preventing food fraud, and promotes more efficient enforcement measures. It also reinforces transparency.

In particular, the Regulation foresees the publication of multi-annual control plans (MANCPs). It reinforces the fight against fraud by laying down more stringent rules for financial penalties. And it modernises the EU system with the new Information Management System for Official Controls (IMSOC) for electronic information sharing.

Rules for exports to the EU include:

A common framework for carrying out border controls (Arts. 44–52)
Categories of products that must be controlled at a border control post (Art. 47) and those that are exempt (Arts. 48 & 53)
Frequency of document, identity and physical checks (Art. 54)
Decisions on consignments (Art. 55)
Prior notification and use of the Common Health Entry Document (CHED) by the operator and competent authorities (Arts. 56–58)
The possibility to intensify controls in cases (or suspicion) of non-compliance (Art. 65)
Measures to be taken in cases of non-compliant consignments entering the EU (Arts. 66–72)
Approval of pre-export controls performed by third countries (Arts. 73–74)
Cooperation between authorities in relation to consignments from third countries (Arts. 75 & 76)
Official certificates and attestations (Arts. 86–91)
Reference laboratories and reference centres (Arts. 92–101)
Planning and reporting: Member States and the Commission have an annual obligation to report on the number and outcomes of official controls performed, and on their MANCP (Arts. 109–115)

Conditions for entry of animals and goods into the Union include:

Information on third countries' control systems (Art. 125)
Additional conditions for entry into the EU of animals and goods (list of third countries, approval of establishments, official certificates, etc.) (Art. 126)
Inclusion in the list of approved third countries (Art. 127)
Safeguard measures in case of identified risks (Art. 128)
Criteria and examination procedure for recognising equivalence (Art. 129)

Supplementary legislation

The Official Controls Regulation is supplemented by many delegated and implementing acts, including the following.

Delegated Regulation (EU) 2022/2292 on Public health requirements for exporting live animals
List of Animal products subject to official controls established by Implementing Regulation (EU) 2021/632, covering animals, products of animal origin, germinal products, animal by-products and derived products, composite products, and hay and straw subject to official controls at border control posts
Delegated Regulation (EU) 2019/2122 on categories of animals and goods exempted from official controls at border control posts (see Regulations regarding CN and HS codes)
Delegated Regulation (EU) 2019/2126 on animals and goods exempted from border post controls (frozen tuna, consignments entering the EU through certain Greek islands and certain French territories)
Delegated Regulation (EU) 2021/630 on composite products exempted from official controls at border control posts
Implementing Regulation (EU) 2019/2129 establishing frequency rates for identity checks and physical checks on certain consignments of animals and goods entering the Union
Regulation (EU) 2019/2130 on the details for documentary, identity and physical checks at border control posts
Implementing Regulation (EU) 2019/1013 on prior notification of certain goods entering the EU
Delegated Regulation (EU) 2019/1602 on the CHED as accompanying document
Implementing Regulation (EU) 2019/1793 on the temporary increase of official controls and emergency measures governing the entry into the EU of certain goods from certain third countries
Implementing Regulation (EU) 2019/1873 on coordinated performance intensified official controls, foreseeing the conditions to end intensified controls
Delegated Regulation (EU) 2021/2305 exemptions from official border post controls for certain organic and in-conversion products
Implementing Regulation (EU) 2019/1715 (the IMSOC Regulation) detailing the IMSOC platforms: Rapid Alert System for Food and Feed (RASFF), Animal Disease Information System (ADIS), the EUROPHYT network, the Trade Control and Expert System (TRACES), and use of the electronic CHED
Implementing Regulation (EU) 2021/405 on Third country lists for public health
Implementing Regulation (EU) 2021/404 on Third country lists for animal health
Implementing Regulations (EU) 2021/403; 2020/2235; and 2020/2236 on EU official health certificates for exports to the EU
Delegated Regulation (EU) 2019/2124 dealing with transit, transhipment and onward transportation through the EU.

Timeline

Date of publication: 7 April 2017

Main date of entry into application: 15 December 2019

Last date of entry into application (regarding provisions on residues): 14 December 2022

What are the major implications for exporting countries?

EU Member States are responsible for enforcing the agri-food legislation. Competent authorities organise official controls systems on their territory to verify that operators' activities and goods placed on the EU market (either EU produced or imported from non-EU countries) comply with relevant standards and requirements.

All business operators must ensure compliance with EU agri-food chain requirements in their daily activities. All operators of any size are subject to official controls.

The role of the EU is to ensure that the control systems at national level in the EU, and in third countries, are effective. This is the responsibility of the Directorate-General for Health and Food Safety (DG SANTE Directorate F), and it carries out controls to ensure that the national authorities in EU countries, and in non-EU countries exporting to the EU, are fulfilling their legal obligations. A multi-annual plan sets out the priorities for its controls for the following 5 years. Each year DG SANTE publishes an annual work programme. See Health and food audits and analysis programme 2024.

Recommended Actions

The Official Controls Regulation is the cornerstone of all legislation dealing, directly and indirectly, with producing food and feed for the EU. A good understanding of its principles and approaches will help AGRINFO partners to obtain and retain approval to export their products to the EU.

Resources

Online resources from the European Commission:

European Commission (2019) Conference: Smarter rules for safer food and plant health. Brussels, 13 December.

Conference presentations:

DG Health and Food Safety (2023) Health and food audits and analysis programme 2024.

Sources

Regulation (EU) 2017/625 (Official Controls Regulation)

Commission notices on:

Official Controls Regulation - explained

Summary