Review of legislation on official controls
Review of legislation on official controls
The European Parliament and the Council reached a political agreement on the new Regulation on Official Controls on 15 June 2016. The Regulation was part of a package of proposals presented by the Commission in May 2013 to strengthen the enforcement of a broad range of rules applicable to the agri-food chain.
The new rules will replace Regulation (EC) No 882/2004 on official controls and other legislation which currently governs the enforcement of rules along the agri-food chain; it is expected to enter into force in the first quarter of 2017 and to be applicable by 2020.
EU Official Control rules are a key element of the governance of the agri-food chain in Europe, which are world-wide recognised as an example of best practice. Those rules provide national enforcers and the Commission with the necessary powers to ensure effective enforcement of regulatory requirements, and with mechanisms that allow full cooperation of all parties involved in ensuring the correct application of the law across national borders.
The Official Controls Regulation also provides the Commission with audit and control powers in the Member States and Third Countries, and with the power to take action at EU level.
To access all main elements and changes of this new regulation, please refer to the detailed information below:
|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 and will now 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, will introduce a more harmonised and coherent approach to official controls and relevant enforcement actions along the entire agri-food chain. Businesses and enforcements authorities alike will 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 current official control regime (i.e. Regulation (EC) 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 will apply 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.
|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.
|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 will 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.
|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 will be 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-compliances observed, and the cases where enforcement measures were taken and penalties were imposed
- Competent Authorities will 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).
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 will remain 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 derogation from 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.
The Commission will be empowered to establish EU Reference Laboratories (EURLs) in those sectors where there is a recognised need to promote uniform practices and reliability of methods of analysis, tests and diagnosis.
The decision to establish an EURL will be taken by a delegated act involving the European Parliament and the actual designation will be implemented by the Commission. This will considerably increase the openness and transparency of the selection process. The designation will be valid for (a minimum five years); the Commission will review the EURLs mandate and operations regularly. Detailed rules are clearly set out about EURLs tasks in the new text of the regulation.
New EU Reference Centres for animal welfare will be established to provide coordinated assistance to Member States in the field of animal welfare within one year from the entry into force of the Regulation. The tasks include:
- carry out scientific and technical studies;
- conduct training courses and disseminate research findings and technical innovations;
- to provide scientific and technical advice for the development and application of animal welfare indicators.
Moreover, the Regulation will provide for the possibility to establish EU Reference Centres for the authenticity and integrity of the agri-food chain, to provide the specialised knowledge in relation to methods for detecting fraudulent or deceptive practices and specific analyses designed to identify areas of the agri-food chain potentially vulnerable to fraud.
|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 will be applicable 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:
1) Methods complying with the relevant Union rules
2) If there are no Union rules, the following methods must be used:
a) Methods in compliance with internationally recognised rules or protocols, including those accepted by the European Committee for Standardisation (CEN), or
b) 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:
3) Methods which comply with relevant rules established at national level.
4) In the absence of the above rules:
a) Relevant methods developed or recommended by national reference laboratories and validated in accordance with internationally accepted scientific protocols; or
b) 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 will 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 will be more risk-based and targeted. Hence it will be less burdensome for Competent Authorities and businesses alike.
A list of animals and goods subject to systematic controls at border will be based on current rules.
Border Control Posts (BCPs) will replace the different Border Inspection Posts (BIPs) and Designated Points of Entry (DPEs) which currently carry out border control tasks. Minimum requirements for facilities, equipment and staff qualifications will apply throughout all border control posts.
All consignments to be presented at the border control posts will undergo documentary checks. Identity and physical checks will be 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 will be established by the Commission.
In principle, all controls will be carried out at the border control post where the consignment arrives. However the Commission is empowered to establish the cases and conditions under which deviations from this principle are allowed. 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), will be used by operators for the prior notification of consignments. It will be 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 will allow 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 will 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.
|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 will be established.
Mandatory fees for certain official controls. List of cost elements to take into account in the calculation of fees.
The Regulation retains the general requirement according to which Member States must ensure that adequate financial resources are available to provide the staff and other resources necessary for the Competent Authority to perform official controls and other official activities.
Mandatory fees will be levied on operators for certain official controls.
a) official controls carried out in slaughterhouses, cutting plants, on milk production and on the production and placing on the market of fishery and aquaculture products;
b) official controls at border control posts (or at control points other than border control posts where permitted) on animals, products of animal origin, germinal products, animal by-products, plants, and plants products;
c) official controls on goods coming from third countrieson the basis of the risk posed;
d) official controls at borders on animals and goods subject to emergency measures or for which conditions or measures have been established to enter the Union;
e) official controls to verify the conditions for the approval of feed premises (feed mills);
f) official controls not originally planned, necessary to follow-up non-compliance.
A) To calculate the amount of fees for the controls at point a) and b) above, Competent Authorities will have the option to choose one of the following methods:
1) fees established at a flat-rate on the basis of the costs borne by the Competent Authorities over a given period of time, and applied to all operators irrespective of whether any official control activity is carried out at any particular operator's premises during the reference period. Member States will be required to take into account the impact that the size and type of the business concerned and the relevant risk associated to these businesses;
2) fees calculated on the basis of the costs of each individual control and applied specifically to the operators subject to the control;
3) fees based on the amounts provided by the Regulation (detailed in the annex). Those amounts no longer constitute minimum fees as provided under the current regime of Regulation (EC) 882/2004.
B) For the official controls at points c) to f) above, the Competent Authorities will recover the actual cost of controls.
The Regulation clarifies which cost elements Competent Authorities need to take into account when calculating the fees. It also requires Member States to consult relevant stakeholders on the general methods used to calculate the fees or charges.
When determining the fees, Competent Authorities shall take into account the salary, social security, pension and insurance costs of support and administrative staff (as well as of staff physically performing official controls); the same applies to the costs of services charged to Competent Authorities by delegated bodies for the official controls delegated to them.
New transparency provisions will require Member States to make public:
- the method and data used to establish fees;
- the fee amount charged to each category of operators and for each category of official controls or other official activities;
- breakdown of costs;
- identity of authorities or bodies responsible for collecting fees.
The increased transparency will be instrumental to enhance the accountability of the Competent Authorities to consumers and businesses, and to promote greater consistency in the application of fees across the EU.
|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 actions is 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 will 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 will be 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.
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.
Concerning the Official Control Regulation, the European Parliament is expected to formally endorse the position of the Council in its plenary meeting of March 2017. Once the adoption procedure is finalised, the Official Control Regulation will become applicable on 14 December 2019.
An overview of the timing of these three legislations is outlined below.
|Animal Health Law||Plant Health Law||
Official Control Regulation
|Adoption date||9 March 2016||26 October 2016||Expected in the plenary of the European Parliament February/March 2017|
|Entry into force date||21 April 2016||14 December 2016||
20 days after the adoption
|Application date||21 April 2021||
14 December 2019
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 will be 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 will be 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 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 timescale for the adoption of these different acts of tertiary legislation varies from:
- one year from the entry into force of the Regulation;
- before the date of application of the Regulation;
- within six years from the date of entry into force.
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.