EU official control rules are a key element of the governance of the agri-food chain in Europe, recognised world-wide as an example of best practice.
These rules provide national authorities and the European Commission with the necessary powers to ensure effective enforcement of regulatory requirements and with mechanisms that allow the full cooperation of all parties involved in ensuring the correct application of the law across national borders.
The Official Controls Regulation also provides the European Commission with audit and control powers in the EU countries and non-EU countries, and with the power to take action at EU level.
Official Controls Regulation (EU) 2017/625
The Official Controls Regulation (EU) 2017/625 addresses 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 (Official Controls Regulation - OCR).
The European Parliament and the Council adopted the new Official Controls Regulation No 2017/625 on 15 March 2017. The Regulation was published in the Official Journal of the European Union on 7 April 2017 and entered into force on the 27 April 2017
The new rules replace Regulation (EU) No 882/2004 on official controls and other legislation which previously governed the control and enforcement of rules along the agri-food chain. The effects of the OCR are:
Repeal of: Regulations (EU) No 854/2004 and (EU) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC, 97/78/EC and Council Decision 92/438/EEC
Amend with respect of control rules: Regulations (EU) No 999/2001, (EU) No 396/2005, (EU) No 1069/2009, (EU) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EU) No 1/2005 and (EU) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC.
The new rules gradually became applicable with the main application date being 14 December 2019. An overview on delegated and implementing acts adopted under Regulation (EU) 2017/625 can be found here.
In the context of the revision of animal health legislation (upcoming entry into application of Regulation (EU) 2016/429 (‘the Animal Health Law’), certificates for the entry into the Union for animals and goods (for human consumption), aquatic animals and products of animal origin and terrestrial animals and germinal products are revised.
- On animals and goods (for human consumption), certificates have been revised by way of Commission Implementing Regulation (EU) 2020/2235 which can be found here.
Below is a PDF version, intended at facilitating the use of the certificates, while only the legal text published in the Official Journal is authentic.
- On aquatic animals and products of animal origin, certificates have been revised by way of Commission Implementing Regulation (EU) 2020/2236 which can be found here.
Below is a PDF version, intended at facilitating the use of the certificates, while only the legal text published in the Official Journal is authentic.
- On terrestrial animals and germinal products, certificates have been revised by way of Commission Implementing Regulation (EU) 2021/403 which can be found here
- Commission Implementing Regulation (EU) 2021/619 of 15 April 2021 amending Implementing Regulations (EU) 2020/2235, (EU) 2020/2236 and (EU) 2021/403 as regards transitional provisions for the use of animal health certificates, animal health/official certificates and official certificates can be found here
- Commission Implementing Regulation (EU) 2021/617 of 14 April 2021 amending Implementing Regulations (EU) 2020/2235 and (EU) 2020/2236 as regards model animal health certificates and animal health/official certificates for the entry into the Union of certain aquatic animals and products of animal origin can be found here
Main Elements of Regulation (EU) 2017/625
The main elements and changes in this regulation are outlined below.
- Risk Based Approach
- Official Controls on the Operator's Processes and Activities
- Transparency of Official Controls – Greater Accountability of Competent Authorities
- Delegation of Control Tasks of the Competent Authorities
- Operators' Obligations
- Official Laboratories
- Sampling, Analysis, Tests and Diagnosis
- Border Controls
- Official Certification
- Administrative Assistance and Cooperation
- Enforcement actions by the Competent Authorities
- Enforcement Measures
- Sector specific control rules
- Relation between Official Controls Regulation and the Animal Health Law & The Plant Health Law
- Commission Empowerments: Future-Proof Legislation
Extended scope to include: food and feed law, animal health and welfare, plant health and animal-by products rules. Clarification for organics and plant protection products.
The scope of the new Regulation has been extended to cover official controls to verify compliance with food and feed law, animal health and welfare, plant health and animal-by products rules.
The extension of the scope to also cover plant health and animal by-products introduces a more harmonised and coherent approach to official controls and relevant enforcement actions along the entire agri-food chain. Businesses and enforcements authorities alike benefit from a simplified framework which integrates official controls rules into a single Regulation.
The new Regulation, in order to overcome certain legal ambiguities, clearly reinstates that organics and plant protection products are within its scope.
As per previous official control regime (i.e. Regulation (EU) No 882/2004), the new Regulation will not cover the verification of compliance with the rules on the common market organisation of agricultural products for which established control systems are in place. The new Regulation however applies to those checks carried out under marketing standards rules (i.e. Article 89 of Regulation (EU) No 1306/2013) with the aim to identify possible instances of fraudulent or deceptive practices involving marketing standards of agricultural products.
The Regulation, unless otherwise provided, clarifies that it also applies to other official activities. Those are the activities other than official controls which, for example, aim to verify the presence of animal diseases or plant pests, or prevent or eradicate those diseases or pests.
Risk Based Approach
Fully risk-based approach to official controls. Minimising the burden on operators.
The risk based approach to controls is maintained: provisions clarify that Competent Authorities when planning their controls need to take into account the operator's past record of compliance and the reliability of the operator's own checks, including those performed by the operator or performed by a third party at the operator's request, like in the case of private quality assurance schemes.
A new provision clarifies that official controls must be performed in a manner that minimises the burden on businesses.
A new key element to strengthen the fight against frauds is the requirement for Competent Authorities to take into account the likelihood of fraudulent and deceptive behaviours when deciding the appropriate frequency of controls.
In particular, Competent Authorities in performing controls and adjusting their frequencies should take account of the likelihood that consumers might be misled about the properties, quality, composition or country of provenance of the food they buy.
Official Controls on the Operator's Processes and Activities
Controls carried out at all stages of production, processing, distribution and use. Register of operators.
The new Regulation clarifies that Competent Authorities have the power to carry out official controls on all operators at all stages of production, processing, distribution and use of animals, goods, substances, materials or objects that are governed by agri-food chain rules. In order to maximise the efficiency of controls, the Regulation requires Competent Authorities to set up and keep an up-to-date register of operators subject to official controls.
Operators need to provide Competent Authorities with updated details about their name, the specific activities they carry out, including activities undertaken by means of distant communication (such as tele and Internet sales), and the places under their control.
In order to reduce the administrative burden, if a list or register of operators already exists for other purposes, Competent Authorities may use the existing list or register. Furthermore, certain categories of operators, for which the registration would be disproportionate to the level of risk posed by the operator's activities, can be exempted via delegated act.
Transparency of Official Controls – Greater Accountability of Competent Authorities
Increased transparency, possibility to publish results of controls and establish rating schemes.
New provisions enhance transparency of official controls and increase Competent Authorities' accountability to consumers and operators by enabling them to obtain information, about the way agri-food chain rules are applied and enforced. For example:
- In order to inform the general public about the effectiveness of control systems, Competent Authorities are required to publish, at least once a year, relevant information about the organisation and performance of official controls
- Competent Authorities must ensure a regular and timely publication of the outcome of official controls; these publications must specify the type and number of controls, the cases of non-compliance observed, and the cases where enforcement measures were taken and penalties were imposed
- Competent Authorities have the option to make publicly available the information about the outcome of official controls on individual operators as long as the operator is given the opportunity to comment on that information and the operator's comments are reflected in the information published
- New rules enable Competent Authorities to make publicly available information about rating scheme systems for operators, based on the outcome of official controls. The rating criteria need to be objective, fair and transparent so that consumers are better informed about the level of compliance of businesses (such as manufacturers, retailers, restaurants).
Delegation of Control Tasks of the Competent Authorities
Clarification about the possibility to delegate official control tasks and other official activities to delegated bodies or natural persons.
Conditions for the delegation.
Under the new Regulation the rules on delegation of official control tasks remain broadly the same. However, it is specified that delegation can be made to delegated bodies or a natural person. New provisions also regulate the delegation of specific tasks as regards other official activities.
The conditions to be met for delegating certain official control tasks include:
- the delegation needs to be in writing and must contain an accurate description of the tasks that the delegated body must perform;
- the delegated body must have the necessary expertise, equipment, suitably qualified and experienced staff to perform the control;
- the delegated body must be impartial, free from conflict of interest and accredited in accordance with standards relevant to the controls tasks to perform;
- effective coordination between the delegating Competent Authority and the delegated body must be ensured.
Competent Authorities must organise audits or inspections of the delegated body or natural person and, if the Competent Authority finds that the delegated body or natural person is not meeting the necessary conditions, the delegation must be withdrawn fully or partly.
Responsibility for taking actions in case of established non-compliance (i.e. enforcement measures) cannot be delegated. Such actions may only be taken by the relevant Competent Authority.
Operators, during official controls, are required to assist and cooperate with the staff of the Competent Authority. More specifically, to the extent necessary to perform official controls, operators must give access to Competent Authority staff to their:
- means of transport,
- documents and any other relevant information
- animals and goods under their controls
Designation of laboratories. Permanent and temporary derogations from mandatory accreditation.
The Regulation sets out rules for the designation of the laboratories carrying out analysis, tests or diagnoses for official controls and the conditions to be designated. Accreditation to EN ISO/IEC 17025 remains a mandatory condition for the designation of all official control laboratories.
Permanent derogation from mandatory accreditation of official control laboratories may be introduced by Competent Authorities for laboratories having a limited scope of activities (e.g. Trichinella in meat).
Temporary derogationfrom mandatory accreditation may be introduced for methods of analysis, tests or diagnosis, which are not covered by accreditation. This would be limited to specific conditions such as:
- emergency situations
- when the method is newly required by EU legislation.
Official laboratories, upon request of the Competent Authority, must make available to the public the names of the methods used for analyses, tests or diagnoses.
Sampling, Analysis, Tests and Diagnosis
Clarification of cascade of methods to be used for sampling, analysis, test and diagnosis.
The new Regulation clarifies that rules on methods of sampling, analysis, tests and diagnosis apply to official controls as well as to other official activities in all the sectors covered by the Regulation. The cascade of methods used for sampling, analysis, tests and diagnosis is clarified and it appears as following:
- Methods complying with the relevant Union rules
- If there are no Union rules, the following methods must be used:
- Methods in compliance with internationally recognised rules or protocols, including those accepted by the European Committee for Standardisation (CEN), or
- Methods developed and recommended by European Union Reference Laboratories and validated in accordance with internationally accepted scientific protocols
In the absence of the above rules or protocols:
- Methods which comply with relevant rules established at national level.
- In the absence of the above rules:
- Relevant methods developed or recommended by national reference laboratories and validated in accordance with internationally accepted scientific protocols; or
- other methods validated with intra-laboratory methods, in accordance with existing internationally accepted scientific protocols.
Common framework for carrying out border controls on animals and goods entering the EU.
The regulation establishes an integrated approach to import controls by eliminating the current fragmentation of requirements. Common rules apply to controls carried out at borders on animals, products of animal origin, plants and other products and goods that must be checked before they enter the EU.
The import control system is more risk-based and targeted. Hence it is less burdensome for Competent Authorities and businesses alike.
A list of animals and goods subject to systematic controls at border has been established (see table), largely building on previous rules.
Border Control Posts (BCPs) replace the different Border Inspection Posts (BIPs) and Designated Points of Entry (DPEs) which previously carries out border control tasks. Minimum requirements for facilities, equipment and staff qualifications apply throughout all border control posts.
All consignments to be presented at the border control posts must undergo documentary checks. Identity and physical checks are carried out at a frequency depending on the risk linked to the specific animals or goods. The criteria to determine and modify the frequency of rates has been established by the Commission (see table).
In principle, all controls must be carried out at the border control post where the consignment arrives. However the Commission has made use of an empowerment to establish the cases and conditions under which deviations from this principle are allowed (see table).
For example onward transportation of animals/goods to the final destination may be authorised, pending the results of the physical checks from the laboratories (where required), and cases where identity can be determined by an experts away from the border control post.
A single standard document, the Common Health Entry Document (CHED), must be used by operators for the prior notification of consignments. It is transmitted to the border control post through a new integrated computerised system for official controls (Integrated Management System for Official Controls, IMSOC).
In particular, IMSOC allows the integration of all existing computerised systems (TRACES, RASFF, Europhyt, AAC), to optimise the handling and exchange of information, data and documents necessary for the enforcement of agri-food chain rules.
New provisions require close cooperation among Competent Authorities, customs authorities and other authorities involved in the controls of animals and goods arriving from third countries to ensure timely exchange of relevant information. The Commission is empowered to detail the functioning of such cooperation.
Uniform and harmonised framework for official certification.
The new Regulation introduces a set of general rules in order to create a uniform and harmonised framework for official certification across Member States in all areas, covered by the scope of the regulation. These rules also apply to certification for exports to Third Countries.
Requirements to issue official certificates include that Competent Authorities issue official certificates and designate the certifying officers who must be impartial, free from conflict of interest and properly trained.
Official certificates must be authentic, accurate and cannot be signed when blank or incomplete. Certificates can only confirm the results of official controls and must enable the identification of the person who signed them.
Some areas require the issuance of attestation, such as plant health, where the attestation also relates to plant passports; this must be done by operators or the Competent Authority.
The Requirements of the attestation officers are the same of those issuing official certificates.
Administrative Assistance and Cooperation
Strengthened mechanism for administrative assistance and cooperation.
The new Regulation clarifies and strengthens rules on Member States Cooperation and administrative assistance, to enable Competent Authorities to deal efficiently with cross-borders non-compliance.
One of the novelties of the Regulation is the specific requirement for Member States to facilitate the exchange of information between Competent Authorities and other enforcement authorities such as public prosecutors on possible cases of non-compliance. This allows a swifter and efficient pursuit of non-compliance.
Furthermore, as part of the overall aim to strengthen cooperation and assistance among Member States an electronic information system is established.
Enforcement actions by the Competent Authorities
Broader scope reflected by modified non-exhaustive list of enforcement actions.
The Regulation retains current requirements according to which actions taken by the Competent Authorities must ensure that the operator remedies the non-compliance. Competent Authorities must take account of the nature of the non-compliance and of the operator's past record of compliance when deciding what action to take.
However, the non-exhaustive list of current enforcement actionsis extended to reflect the broader scope of the new Regulation. For instance, the list of measures will now include:
- restriction or prohibition of movements of animals;
- the slaughter or killing of animals provided it is the most appropriate measure to safeguard public health and animal health and welfare;
- closing the website of the operator.
The Commission is empowered to adopt a number of measures where there is evidence that the system of controls in a Member State faces serious disruption to the point that it constitutes a widespread risk to the agri-food chain, and the Member State has not addressed the shortcomings within a time limit set by the Commission. These would include for example the prohibition to place on the market animals or goods affected by the disruption, their transport, and the suspension of official controls at the border control post where the serious disruption takes place.
Reinforced rules on financial penalties for fraudulent or deceptive practices.
New provisions for the protection of whistle-blowers.
To deter fraudulent behaviours and foster fair competition among businesses, the Regulation introduces more stringent rules for financial penalties, imposed by Member States. Those penalties need to reflect the economic advantage of the operator or a percentage of the operator’s turnover.
The Regulation also introduces new provisions to protect whistle-blowers to encourage and facilitate the reporting of non-compliance. Member States are required to have a mechanism in place that at least needs to include:
- procedures for receiving infringements reports and their follow-up;
- appropriate protection of the whistle-blower against retaliation, discrimination and any other type of unfair treatment;
- data protection of the whistle-blower in accordance with Union and national laws.
Sector specific control rules
The Official Control Regulation repeals a number of sector specific official control provisions in different acts to incorporate corresponding requirements within its proper rules. This concerns control provisions control rules on:
- products of animal origin
- residues of substances in food and feed
- animals, products of animal origin, germinal products, animal by-products and derived products
- welfare requirements for animals
- plant health
- plant protection products
- GMOs for of food /feed production + GM food/feed
- protected designations of origin, protected geographical indications and traditional specialities guaranteed
Further rules on these subjects and on organic production and labelling of organic products as well as on newly identified risks in relation to food and feed may be adopted via specific empowerments.
The Official Controls Regulation and the Animal Health Law and Plant Health Law: timing and relationship
In 2016 three major legislative developments took place in the area of food safety: the Animal Health Law and the Plant Health Law were adopted, and the Official Controls Regulation was politically agreed.
Relationship among the three legislations
The Animal Health Law and the Plant Health Law lay down some of the conditions to ensure the safety of the food chain. The compliance of these conditions and requirements are verified through the official controls by the Competent Authorities in the Member States, performed in accordance with the Official Controls Regulation. Therefore, the application of the Official Controls Regulation is crucial to ensure the compliance of the rules laid down in the Animal Health Law, Plant Health Law and in other legislations regulating food safety. The application date of these three legislations ensures that official controls rules will be in place to avoid legal gaps and inconsistencies of control rules.
The Animal Health Law creates a single regulatory framework for transmissible animal diseases. It contains both general principles and basic rules, with a strong focus on prevention, and clarifies the responsibilities of all actors dealing with animal health. Detailed requirements are established, for instance, on the registration and approval of establishments, traceability of animals and animal health requirements for movements of animals and their products in the Union, their entry into the Union and specific measures for animal disease prevention and control.
The Plant Health Law establishes a regulatory framework for protective measures against pests of plants, also with a strong focus on prevention. It provides better instruments for a prompt control of the presence and spread of pests in Europe. For instance, it contains rules on surveys, contingency plans, plant passports and phytosanitary certificates.
Commission Empowerments: Future-Proof Legislation
Commission empowerments to adapt official control requirements by delegated/implementing acts.
The Regulation contains a number of Commission empowerments for delegated and implementing acts that will provide the necessary legal means to adjust controls to the needs of a constantly changing agri-food chain environment.
The Commission will carry out the necessary consultation with Member States experts and stakeholders prior to the adoption of the relevant proposals. Where appropriate, the Commission will be assisted by several Regulatory Committees: the Standing Committee on Plants, Animals, Food and Feed, the Regulatory Committee on Organic Production and the Agricultural Product Quality Policy Committee. These committees consist of Member State experts who will provide their opinions before an implementing act is adopted.
- First EU Reference Centre for animal welfare: call for selection launched
- March 2017: Statement by Commissioner Andriukaitis on the Adoption of the Regulation on Official Controls
- June 2016: Statement by Commissioner Andriukaitis on the political agreement reached on the EU proposal for revision of the provisions on official controls along the food chain
- Questions and Answers on veterinary border controls
- The Proposal
- Citizens' Summary
- Impact Assessment
- Executive summary of IA