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 Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) 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 (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) 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 and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation)Text with EEA relevance. - Main contents

EN

Official Journal of the European Union

L 95/1

The Treaty on the Functioning of the European Union (TFEU) requires a high level of protection of human and animal health and of the environment to be ensured in the definition and implementation of Union policies and activities. The achievement of that objective should, inter alia, be pursued via measures in the veterinary and phytosanitary fields which have as their final objective the protection of human health.

The TFEU also provides that the Union is to contribute to the attainment of a high level of consumer protection by the measures it adopts in the context of the completion of the internal market.

Union legislation provides for a set of harmonised rules to ensure that food and feed are safe and wholesome, and that activities which might have an impact on the safety of the agri-food chain or on the protection of consumers’ interests in relation to food and food information are performed in accordance with specific requirements. Union rules exist also to ensure a high level of human, animal and plant health as well as animal welfare along the agri-food chain and in all those areas of activity where a key objective is the fight against the possible spread of animal diseases, in some cases transmissible to humans, or of pests injurious to plants or plant products, and to ensure the protection of the environment from risks that might arise from genetically modified organisms (GMOs) or plant protection products. The correct application of those rules, hereinafter collectively referred to as ‘Union agri-food chain legislation’, contributes to the functioning of the internal market.

The basic Union rules with regard to food and feed law are laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council (4). In addition to those basic rules, more specific food and feed law covers different areas such as animal nutrition, including medicated feedingstuffs, food and feed hygiene, zoonoses, animal by-products, residues of veterinary medicinal products, contaminants, control and eradication of animal diseases with a human health impact, food and feed labelling, plant protection products, food and feed additives, vitamins, mineral salts, trace elements and other additives, food contact materials, quality and compositional requirements, drinking water, ionisation, novel foods and GMOs.

Union legislation on animal health aims to ensure high standards of human and animal health in the Union, the rational development of the agriculture and aquaculture sectors, and to increase productivity. That legislation is necessary to contribute to the completion of the internal market for animals and animal products and to avoid the spread of infectious diseases of Union concern. It covers areas that include intra-Union trade, entry into the Union, disease eradication, veterinary controls and notification of diseases, and also contributes to the safety of food and feed.

Transmissible animal diseases, including by micro-organisms that have developed resistance to antimicrobials, may have a significant impact on public health, food and feed safety, and animal health and welfare. In order to ensure high standards of animal and public health in the Union, rules on animal health measures and on feed and food safety are laid down at Union level. Compliance with those rules, including the rules that are intended to tackle the problem of antimicrobial resistance, should be subjected to the official controls provided for in this Regulation. Additionally, Union legislation provides for rules on the placing on the market and use of veterinary medicinal products which contribute to coherent action at Union level directed at enforcing the prudent use of antimicrobials at farm level and at minimising the development of antimicrobial resistance in animals and its transmission through food of animal origin. Actions number 2 and 3 advocated by the Communication of 15 November 2011 from the Commission to the European Parliament and to the Council entitled ‘Action plan against the rising threats from Antimicrobial Resistance’ emphasise the essential role played by the specific Union rules in the area of veterinary medicinal products. Compliance with those specific rules should be subjected to the controls provided for in that Union legislation and, therefore, does not fall within the scope of this Regulation.

Article 13 TFEU recognises that animals are sentient beings. Union legislation on animal welfare requires animal owners, animal keepers and competent authorities to respect welfare requirements of animals to ensure their humane treatment and avoid causing them unnecessary pain and suffering. Those rules are based on scientific evidence and may improve the quality and safety of food of animal origin.

Union legislation on plant health regulates the entry, establishment and spread of pests of plants that do not exist, or are not widely present, in the Union. Its objective is to protect the health of Union crops and of public and private green space and forests while simultaneously safeguarding the Union’s biodiversity and environment, and ensure the quality of plants and plant products and safety of food and feed made from plants.

Union legislation on plant protection products regulates the authorisation, placing on the market, use and control of plant protection products and of any active substances, safeners, synergists, co-formulants and adjuvants, which they might contain or of which they might consist. The objective of those rules is to ensure a high level of protection of both human and animal health and of the environment through evaluation of the risks posed by plant protection products, while improving the functioning of the Union market through harmonisation of the rules for their placing on the market and while also improving agricultural production.

Directive 2001/18/EC of the European Parliament and of the Council (5) and Regulation (EC) No 1829/2003 of the European Parliament and of the Council (6) provide for the prior authorisation, traceability and labelling of GMOs and genetically modified food and feed. GMOs which are not for the purpose of direct consumption, such as seeds used as source material for the production of food and feed, are able to be authorised under Directive 2001/18/EC or under Regulation (EC) No 1829/2003. Irrespective of the legal basis under which GMOs could be authorised, the same rules on official controls should apply.

Union legislation on organic production and labelling of organic products provides a basis for the sustainable development of organic production and aims to contribute to the protection of natural resources, biodiversity and animal welfare, and the development of rural areas.

Union legislation on agricultural quality schemes for agricultural products and foodstuffs identifies products and foodstuffs farmed and produced to exact specifications whilst encouraging diverse agricultural production, protecting product names and informing consumers about the specific character of agricultural products and foodstuffs.

Union agri-food chain legislation is based on the principle that operators at all the stages of production, processing and distribution which are under their control are responsible for ensuring compliance with the requirements relevant to their activities established by Union agri-food chain legislation.

Union rules on marketing standards for fishery and aquaculture products ensure sustainable products and the realisation of the full potential of the internal market; they facilitate marketing activities based on fair competition, thereby helping to improve the profitability of production. These rules ensure compliance with the same requirement both for imports and products originating from within the Union. Union rules on marketing standards for agricultural products contribute to improving the economic conditions for the production and marketing and the quality of such products.

The responsibility to enforce Union agri-food chain legislation lies with Member States, whose competent authorities monitor and verify, through the organisation of official controls, that relevant Union requirements are effectively complied with and enforced.

Regulation (EC) No 882/2004 of the European Parliament and of the Council (7) has established a single legislative framework for the organisation of official controls. That framework has significantly improved the efficiency of official controls, the enforcement of Union agri-food chain legislation and the level of protection against risks to human, animal and plant health and animal welfare in the Union and the level of protection of the environment from risks that might arise from GMOs and plant protection products. It has also provided a consolidated legal framework to support an integrated approach towards the performance of official controls along the agri-food chain.

There are a number of provisions in Union agri-food chain legislation, the enforcement of which has not, or has only partially, been governed by Regulation (EC) No 882/2004. In particular, specific official control rules were kept in place in Regulation (EC) No 1069/2009 of the European Parliament and of the Council (8). Plant health also largely falls outside the scope of Regulation (EC) No 882/2004 with certain rules on official controls being laid down in Council Directive 2000/29/EC (9).

Council Directive 96/23/EC (10) also provides a very detailed set of rules that establish inter alia the minimum frequency of official controls and specific enforcement measures to be adopted in cases of non-compliance.

In order to rationalise and simplify the overall legislative framework, whilst simultaneously pursuing the objective of better regulation, the rules applicable to official controls in specific areas should be integrated into a single legislative framework for official controls. For that purpose, Regulation (EC) No 882/2004 and other Union acts currently governing official controls in specific areas should be repealed and replaced by this Regulation.

This Regulation should seek to establish a harmonised Union framework for the organisation of official controls, and official activities other than official controls, along the entire agri-food chain, taking into account the rules on official controls laid down in Regulation (EC) No 882/2004 and in relevant sectoral legislation, and the experience gained from the application of those rules.

The rules which set out the requirements for the sustainable use of plant protection products laid down in Directive 2009/128/EC of the European Parliament and of the Council (11) include, in Article 8 thereof, provisions on the inspection of application equipment, which will continue to apply while the rules on official controls of this Regulation do not apply to those inspection activities.

For the verification of compliance with the rules on the common organisation of the markets of agricultural products (arable crops, wine, olive oil, fruit and vegetables, hops, milk and milk products, beef and veal, sheepmeat and goatmeat and honey), a well-established and specific control system is already in place. This Regulation should therefore not apply to the verification of compliance with Regulation (EU) No 1308/2013 of the European Parliament and of the Council (12) governing the common organisations of the markets in agricultural products, except where the controls carried out in relation to marketing standards under Regulation (EU) No 1306/2013 of the European Parliament and of the Council (13) indicate possible cases of fraudulent or deceptive practices.

Certain definitions currently set out in Regulation (EC) No 882/2004 should be adapted to take account of the broader scope of this Regulation, to align them with those set out in other Union acts, and to clarify or, where appropriate, replace terminology having different meanings in different sectors.

Where Union agri-food chain legislation requires the competent authorities to verify that the operators comply with the relevant Union rules and that the animals or goods meet specific requirements for the purpose of issuing official certificates or attestations, such verification of compliance should be considered as an official control.

Union agri-food chain legislation entrusts additionally the competent authorities of the Member States with specialised tasks to be carried out for the protection of animal health, plant health and animal welfare and for the protection of the environment in relation to GMOs and plant protection products. Those tasks are the public interest activities which the competent authorities of the Member States are required to carry out for the purpose of eliminating, containing or reducing any hazard which may arise for human, animal or plant health, animal welfare or also for the environment. Those other official activities, which include the granting of authorisations or approvals, the epidemiological surveillance and monitoring, eradication and containment of diseases or pests, as well as the issuance of official certificates or attestations, are governed by the same sectoral rules which are enforced through the official controls and therefore by this Regulation.

Competent authorities should be designated by the Member States for all the areas that fall within the scope of this Regulation. While Member States are best placed to identify and decide which are the competent authority or authorities to designate for each area or part thereof, they should also be required to designate a single authority that for each area or part of area ensures appropriately coordinated communication with other Member States’ competent authorities and with the Commission.

For the performance of official controls aimed at verifying the correct application of Union agri-food chain legislation, and of the other official activities entrusted to Member State authorities by Union agri-food chain legislation, Member States should designate competent authorities which act in the public interest, are appropriately resourced and equipped, and offer guarantees of impartiality and professionalism. Competent authorities should ensure the quality, consistency and effectiveness of official controls.

The correct application and enforcement of the rules falling within the scope of this Regulation require appropriate knowledge of both those rules and the rules of this Regulation. It is therefore important that the staff performing official controls and other official activities are regularly trained on the applicable legislation, in accordance with their area of competence, as well as on the obligations resulting from this Regulation.

The competent authorities should carry out internal audits or have audits carried out on their behalf, to ascertain compliance with this Regulation. Those audits should be carried out in a transparent manner and be subject to independent scrutiny.

Operators should have the right, subject to national law, to appeal against the decisions taken by the competent authorities. The competent authorities should inform operators of that right.

The competent authorities should ensure that the staff responsible for official controls does not disclose information acquired during the performance of those controls where that information is covered by professional secrecy. Unless there is an overriding interest to justify disclosure, professional secrecy should include information which would undermine the purpose of inspections, investigations or audits, the protection of commercial interests or the protection of court proceedings and legal advice. However, professional secrecy should not prevent competent authorities from publishing factual information on the outcome of official controls regarding individual operators when the operator concerned has been allowed to comment upon it prior to the disclosure and such comments have been taken into account, or released alongside the information being disclosed by the competent authorities. The need to respect professional secrecy is also without prejudice to the obligation for competent authorities to inform the general public where there are reasonable grounds to suspect that a food or feed may present a risk for health under Article 10 of Regulation (EC) No 178/2002. The right of individuals to the protection of their personal data as provided for in Directive 95/46/EC of the European Parliament and of the Council (14) should not be affected by this Regulation. These rules should also be without prejudice to situations where disclosure is required by Union or national legislation.

Competent authorities should perform official controls regularly, on a riskbasis and with appropriate frequency, on all the sectors and in relation to all operators, activities, animals and goods governed by Union agri-food chain legislation. The frequency of official controls should be established by the competent authorities having regard to the need to adjust the control effort to the risk and to the level of compliance expected in the different situations, including the possible violations of the Union agri-food chain legislation perpetrated through fraudulent or deceptive practices. Accordingly, the likelihood of non-compliance with all the areas of the Union agri-food chain legislation which fall within the scope of this Regulation should be taken into account where adjusting the control efforts. In some cases, however, and in view of the issuance of an official certificate or attestation which is a pre-requisite for the placing on the market or for the movements of animals or goods, Union agri-food chain legislation requires that official controls be performed irrespective of the level of risk or the likelihood of non-compliance. In such cases, the frequency of the official controls is dictated by the certification or attestation needs.

To preserve the effectiveness of official controls in the verification of compliance, no notice should be given prior to performing controls, unless such prior notice is absolutely necessary for the controls to be carried out (for example, in the case of those official controls performed in slaughterhouses during slaughter operations which require the continuous or regular presence of staff or representatives of the competent authorities in the operator’s premises) or the nature of the official control activities requires otherwise (as is particularly the case with regard to audit activities).

Official controls should be thorough and effective and should ensure that Union legislation is applied correctly. Given that official controls may represent a burden for operators, competent authorities should organise and conduct official control activities taking their interests into account and limiting the said burden to that which is necessary for the performance of efficient and effective official controls.

Official controls should be performed by staff who are independent, that is free from any conflict of interest, and in particular who are not in a situation which, directly or indirectly, could affect their ability to carry out their professional duties in an impartial manner. Appropriate arrangements should also be in place to ensure impartiality in cases where official controls are performed on animals, goods, places or activities which belong to a public authority or body.

Official controls should be performed with the same level of care by the competent authorities of the Member State irrespective of whether the rules being enforced apply to activities which are only relevant on the territory of that Member State or to activities which will have an impact on the compliance with Union legislation on animals and goods which are to be moved or placed on the market in another Member State or exported outside the Union. In the case of exports outside the Union, competent authorities may also be required, in accordance with Union legislation, to verify the conformity of animals and goods with requirements established by the third country of destination of such animals or goods. Furthermore, as regards the establishments of models for export certificates, the relevant implementing powers provided for in this Regulation should only apply where such certification is provided for in Union law, and in particular in bilateral agreements concluded between the Union and a third country or an association of third countries.

Without prejudice to traceability requirements laid down in sectorial legislation, and to the extent strictly necessary for organising official controls, operators should be able, in exceptional circumstances, to be required by the competent authorities of a Member State to report the arrival of animals and goods from another Member State.

To ensure that the Union agri-food chain legislation is correctly enforced, the competent authorities should have the power to perform official controls at all stages of production, processing and distribution of animals and goods concerned by that legislation. To ensure that official controls are thoroughly conducted and effective, the competent authorities should also have the power to perform official controls at all stages of production and distribution of goods, substances, materials or objects which are not governed by Union agri-food chain legislation insofar as it is necessary to fully investigate possible infringements of that legislation and to identify the cause of any such infringement. In order to perform those official controls efficiently, competent authorities should draw up and maintain a list or register of the operators to be controlled.

The competent authorities act in the interest of operators and of the general public ensuring that the high standards of protection established by Union agri-food chain legislation are consistently preserved and protected through appropriate enforcement action, and that compliance with such legislation is verified across the entire agri-food chain through official controls. The competent authorities, as well as delegated bodies and natural persons to which certain tasks have been delegated, should therefore be accountable to the operators and to the general public for the efficiency and effectiveness of the official controls they perform. They should provide access to information concerning the organisation and performance of official controls and other official activities, and regularly publish information concerning official controls and the results obtained. Competent authorities should also, subject to certain conditions, be entitled to publish or to make available information about the rating of individual operators based on the outcome of official controls. The use of rating schemes by Member States should be allowed and encouraged as a means to increase transparency along the agri-food chain, provided that appropriate guarantees of fairness, consistency, transparency and objectiveness are offered by such schemes. The competent authorities should have the necessary arrangements in place in order for the rating to reflect accurately the actual level of compliance; in particular, competent authorities should be encouraged to ensure that the rating is based on the outcome of several official controls or, when the rating is based on the outcome of one single official control and the findings are unfavourable, that subsequent official controls are carried out within a reasonable time. The transparency of rating criteria is particularly necessary so that best practices can be compared and, in time, the development of a consistent approach at Union level considered.

It is of importance that competent authorities as well as delegated bodies and natural persons to which certain tasks have been delegated, ensure and verify the effectiveness and the consistency of the official controls they perform. For that purpose they should act on the basis of written documented procedures and should provide information and instructions to staff performing official controls. They should also have appropriate documented procedures and mechanisms in place to verify continuously that their own action is effective and consistent, and take corrective action when shortcomings are identified.

To facilitate the identification of cases of non-compliance and to streamline the taking of corrective action by the operator concerned, the outcome of official controls should be recorded in a written form and a copy should be given to the operator on request. Where official controls require the continuous or regular presence of the staff of the competent authorities to monitor the operator’s activities, a written record of each individual inspection or visit to the operator would be disproportionate. In such cases, written records should be prepared with a frequency that enables the competent authorities and the operator to be informed regularly of the level of compliance and promptly notified of any identified shortcomings or non-compliance.

Operators should cooperate fully with competent authorities, delegated bodies or natural persons to which certain tasks have been delegated, to ensure the smooth performance of official controls and to enable the competent authorities to perform other official activities. Operators responsible for a consignment entering the Union should provide all available information related to that consignment. All operators should provide to the competent authorities at least the information needed to identify themselves, their activities and the operators which they supply and which supply them.

This Regulation establishes a single legislative framework for the organisation of official controls to verify compliance with Union agri-food chain legislation in all the areas that such legislation covers. In some of those areas, Union legislation lays down detailed requirements to be complied with which require special skills and specific means for the performance of official controls. To avoid diverging enforcement practices which could generate uneven protection of human, animal and plant health, animal welfare and, as regards GMOs and plant protection products, also of the environment, disrupt the functioning of the internal market for animals and goods falling within the scope of this Regulation and distort competition, the Commission should be able to supplement the rules laid down in this Regulation through the adoption of specific official control rules capable of catering for the needs of controls of those areas. In particular, such rules should lay down specific requirements for the performance of official controls and the minimum frequency for such controls, specific or additional measures to those provided for in this Regulation that competent authorities should take in relation to cases of non-compliance, specific responsibilities and tasks of the competent authorities in addition to those provided for in this Regulation and specific criteria for triggering the administrative assistance mechanism provided for in this Regulation. In other cases, such additional rules might become necessary in order to provide a more detailed framework for the performance of official controls in relation to food and feed, where new information emerges about risks to human or animal health or, in relation to GMOs and plant protection products, also to the environment, indicating that in the absence of common specifications for the performance of official controls across the Member States, the controls would fail to deliver the expected level of protection against those risks, as provided for by Union agri-food chain legislation.

To enable the efficient organisation of the official controls covered by this Regulation, Member States should have the discretion to identify the most appropriate staff to perform such controls provided that a high level of protection of human, animal and plant health and animal welfare is ensured throughout the agri-food chain and that international standards and obligations are met. However, in certain cases, where their specific skills are necessary to ensure a sound outcome of the official controls, Member States should be required to refer to official veterinarians, plant health officers or other specifically designated persons. That should be without prejudice to the possibility for Member States to also use official veterinarians (including for official controls on poultry and lagomorphs) plant health officers or other specifically designated persons in cases where this is not required in accordance with this Regulation.

For the purpose of developing new control methods and techniques in relation to official controls on meat production, competent authorities should be allowed to adopt national measures to implement pilot projects that are limited in time and scope. Such measures should ensure that competent authorities verify that operators comply with all the fundamental provisions applicable to meat production, including the requirement that meat is safe and fit for human consumption. In order to ensure that the Commission and the Member States have the possibility to assess the impact of such national measures and express their opinion before they are adopted, and take therefore the most appropriate action, those measures should be notified to the Commission in accordance with and for the purposes of Articles 5 and 6 of Directive (EU) 2015/1535 of the European Parliament and of the Council (15).

The competent authorities should be able to delegate some of their tasks to other bodies. Appropriate conditions should be laid down to ensure that the impartiality, quality and consistency of the official controls and of the other official activities are preserved. The delegated body should in particular be accredited according to the International Organisation for Standardisation (ISO) standard for the performance of inspections.

To ensure the reliability and consistency of official controls and other official activities across the Union, the methods used for sampling and for laboratory analyses, tests and diagnoses should meet scientific standards, satisfy the specific analytical, testing and diagnostic need of the laboratory concerned, and offer sound and reliable analytical, test and diagnostic results. Clear rules should be established for the choice of the method to be used where more than one is available from different sources, such as ISO, the European and Mediterranean Plant Protection Organization (EPPO), the International Plant Protection Convention (IPPC), the World Organization for Animal Health (OIE), European Union and national reference laboratories, or national law.

Operators whose animals or goods are subject to sampling, analysis, test or diagnosis in the context of official controls should have the right to a second expert opinion, at their own expense. Such a right should allow the operator to request a documentary review by another expert of the initial sampling, analysis, test or diagnosis, as well as a second analysis, test or diagnosis of the parts of the sampling material taken initially unless any such second analysis, test or diagnosis is technically impossible or irrelevant. Such would be the case, in particular, where the prevalence of the hazard is particularly low in the animal or good or its distribution particularly sparse or irregular for the purpose of assessing the presence of quarantine organisms or, as the case may be, for performing a microbiological analysis.

For the purposes of performing official controls on trade which take place through the internet or other remote means, competent authorities should be able to obtain samples through anonymously placed orders (also known as mystery shopping) which can then be analysed, tested or subject to a verification of compliance. All steps should be taken by the competent authorities to preserve the rights of the operators to a second expert opinion.

Laboratories designated by the competent authorities to carry out analyses, tests and diagnoses on samples taken in the context of official controls and other official activities should possess the expertise, equipment, infrastructure and staff to carry out such tasks to the highest standards. To ensure sound and reliable results, those laboratories should be accredited for the use of these methods according to standard EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’. The accreditation should be delivered by a national accreditation body operating in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council (16).

While accreditation is the instrument of choice to ensure high performance by official laboratories, it is also a complex and costly process, which would result in a disproportionate burden for the laboratory in cases where the method of laboratory analysis, test or diagnosis is particularly simple to perform and does not require specialised procedures or equipment, as is the case for the detection of Trichinella in the context of the inspection and, under certain conditions, in cases where the laboratory only carries out analyses, tests or diagnoses in the context of other official activities and not of official controls.

In order to ensure the flexibility and proportionality of the approach, in particular for animal health or plant health laboratories, provision should be made for the adoption of derogations aimed at allowing certain laboratories not to be accredited for all the methods they use. That happens in particular where validated methods for detecting particular pests of plants are not available. Moreover, accreditation of a laboratory for all the methods that it should use as an official laboratory might not be immediately available in cases where new or recently modified methods are to be used, in cases of emerging risks or in emergency situations. Under certain conditions, official laboratories should therefore be allowed to carry out analyses, tests and diagnoses for the competent authorities before they obtain the relevant accreditation.

Official controls performed on animals and goods entering the Union from third countries are of key importance since these controls ensure compliance with legislation applicable within the Union and, in particular, with the rules established to protect human, animal and plant health, animal welfare and, as regards GMOs and plant protection products, also the environment. Such official controls should take place before the animals or goods are released for free circulation within the Union. The frequency of official controls should adequately address risks to human, animal and plant health, animal welfare and to the environment that animals and goods entering the Union might pose, taking into account the operator’s history of compliance with the requirements provided for in Union agri-food chain legislation, the controls already performed on those animals and goods in the third country concerned, and the guarantees given by that third country that animals and goods exported to the Union meet the requirements laid down in Union legislation.

It is necessary to provide for the categories of animals and goods which should always be presented at a border control post for official controls to be performed prior to their entry into the Union. It is also necessary to provide for the possibility of requiring that other categories of goods be subject temporarily to the same requirement by virtue of specific measures to that effect, and for the possibility of requiring that certain other categories of goods, and in particular certain foodstuffs containing both products of plant origin and processed products of animal origin (composite products), always be presented for official controls at a border control post prior to their entry into the Union.

Given the risks to human, animal or plant health, animal welfare or to the environment that certain animals or goods may pose, they should be subject to specific official controls to be performed upon them on their entry into the Union. Current Union rules require the performance of official controls at Union borders to verify that human health, animal health and animal welfare standards applicable to animals, products of animal origin, germinal products and animal by-products are met and that plants and plant products comply with phytosanitary requirements. Increased controls on entry into the Union are also performed on certain other goods where emerging or known risks so warrant. The specificities of such controls, currently governed by Council Directives 97/78/EC (17), 91/496/EEC (18) and 2000/29/EC and Commission Regulation (EC) No 669/2009 (19) should be provided for in this Regulation.

In order to reinforce the efficiency of the Union’s official control system, ensure an optimal allocation of official control resources assigned to border controls and facilitate the enforcement of Union agri-food chain legislation, a common integrated system of official controls at border control posts, replacing the current fragmented control frameworks, should be established to handle all consignments which, given the risk they may carry, should be controlled on their entry into the Union.

Official controls should be performed on consignments upon their arrival at border control posts. Those official controls should include documentary checks on all consignments, including where appropriate checks by electronic means, as well as identity checks and physical checks performed at an appropriate frequency dependent on the risk posed by each consignment of animals or goods.

The frequency of physical checks should be determined and modified on the basis of risks to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment. That approach should enable the competent authorities to allocate resources for controls where the risk is highest. The frequency of identity checks should also be subject to reduction or limited to the verification of a consignment’s official seal where this is justified by a reduced risk posed by the consignments entering the Union. The risk-based approach to identity checks and physical checks should be pursued by making use of available data sets and information, and of computerised data collection and management systems.

In certain cases, and provided that high levels of human, animal and plant health, animal welfare and, in relation to GMOs and plant protection products, also protection of the environment are ensured, official controls normally performed by competent authorities at border control posts could be performed at other control points or by other authorities.

For the purpose of organising an efficient system of official controls, consignments arriving from third countries which require controls at their entry into the Union should be accompanied by a common health entry document (CHED), to be used for the prior notification of the arrival of consignments at the border control post, and to record the outcome of official controls performed and of decisions taken by the competent authorities in relation to the consignment which they accompany. The same document should be used by the operator to obtain clearance by customs authorities once all official controls have been performed.

In some Member States, due to specific geographical constraints, such as long coasts or borders, the minimum requirements for border control posts are difficult to fulfil on a permanent basis. Imports of unprocessed logs of wood are usually done in large volumes through specialised ports or control points and with an irregular frequency which make it difficult to have permanently staffed and fully equipped border control posts. Derogations from minimum requirements for border control posts should be allowed to ensure effective official controls on specific unprocessed logs of wood.

Official controls on animals and goods entering the Union from third countries should be performed at border control posts designated by Member States in accordance with a set of minimum requirements. The designation of such posts should be withdrawn or suspended when they no longer comply with the minimum requirements or when their activities could pose a risk to human, animal or plant health, animal welfare or, in the case of GMOs and plant protection products, also to the environment. The decision whether to withdraw or suspend such a designation would need to take account of the degree of seriousness of the risk and of the principle of proportionality.

To ensure the uniform application of official control rules on consignments arriving from third countries, common rules should be established to govern the actions that the competent authorities and operators should take in the event of suspicion of non-compliance, and in relation to non-compliant consignments and of consignments which might pose a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment.

In order to avoid inconsistencies and duplications in carrying out official controls, to allow consignments which are subject to official controls at border control posts and at other control points to be timely identified and to ensure that controls are performed in an efficient manner, cooperation and exchange of information amongst competent authorities, customs authorities and other relevant authorities dealing with consignments arriving from third countries should be ensured.

Member States should ensure that adequate financial resources are always available in order to appropriately staff and equip the competent authorities performing official controls and other official activities. Although operators are primarily responsible for ensuring that their activities are carried out in compliance with Union agri-food chain legislation, the system of own controls that they put in place for that purpose should be complemented by a dedicated system of official controls maintained by each Member State to ensure effective market surveillance along the agri-food chain. Such a system is, by its very nature, complex and resource-demanding and should be provided with a stable influx of resources for official controls, and at a level appropriate to the enforcement needs at any given moment. To reduce the dependency of the official control system on public finances, competent authorities should collect fees or charges to cover the costs they incur when performing official controls on certain operators and for certain activities for which Union agri-food chain legislation requires registration or approval in accordance with Union rules on the hygiene of food and feed or rules governing plant health. Fees or charges should also be collected from operators to compensate the costs of official controls performed in view of issuing an official certificate or attestation and costs of official controls performed by the competent authorities at border control posts.

Fees or charges should cover, but not exceed, the costs, including overhead costs, incurred by the competent authorities to perform official controls. Overhead costs could include the costs of the support and organisation necessary for planning and carrying out the official controls. Such costs should be calculated on the basis of each individual official control or on the basis of all official controls performed over a given period of time. Where fees or charges are applied on the basis of the actual cost of individual official controls, operators with a good record of compliance should bear lower overall charges than non-compliant ones, as they should be subject to less frequent official controls. In order to promote compliance with Union legislation by all operators irrespective of the method (based on actual costs or on a flat rate) that each Member States has chosen for the calculation of the fees or charges, when fees or charges are calculated on the basis of overall costs incurred by the competent authorities over a given period of time, and imposed on all operators irrespective of whether they are subject to an official control during the reference period, those fees or charges should be calculated so as to reward operators with a consistent good record of compliance with Union agri-food chain legislation.

The direct or indirect refund of fees or charges collected by the competent authorities should be prohibited as it would put at a disadvantage operators not benefitting from the refund and potentially create distortions of competition.

The financing of official controls through fees or charges collected from operators should be fully transparent, so as to enable citizens and businesses to understand the method and data used to establish fees or charges.

Union agri-food chain legislation establishes the cases where the placing on the market or the movement of certain animals or goods should be accompanied by an official certificate signed by the certifying officer. It is appropriate to establish a common set of rules laying down the obligations of the competent authorities and the certifying officers with regard to the issuance of official certificates as well as the characteristics that official certificates should have to ensure their reliability.

In other cases, the rules falling within the scope of this Regulation provide that the placing on the market or the movement of certain animals or goods are to be accompanied by an official label, official mark or other official attestation issued by the operators under the official supervision of the competent authorities or by the competent authorities themselves. Official attestations include, for example, plant passports, organic logos and identification marks, where these are required by Union legislation, and marks of protected designations of origin, protected geographical indications or traditional specialities guaranteed. It is appropriate to lay down a minimum set of rules to ensure that also the issuance of official attestations is able to be performed in accordance with appropriate guarantees of reliability.

Official controls and other official activities should be based on analytical, testing and diagnostic methods that meet state-of-the-art scientific standards and offer sound, reliable and comparable results across the Union. The methods used by official laboratories as well as the quality and uniformity of analytical, testing and diagnostic data generated by them should therefore be improved continuously. For that purpose, the Commission should be able to designate, and rely on the expert assistance of, European Union reference laboratories in all those areas of the agri-food chain where there is the need for precise and reliable analytical, testing and diagnostic results. The European Union reference laboratories should in particular ensure that national reference laboratories and official laboratories are provided with up-to-date information on available methods, organise or participate actively in inter-laboratory comparative tests and offer training courses for national reference laboratories or official laboratories.

The first paragraph of Article 32 of Regulation (EC) No 1829/2003 and the first paragraph of Article 21 of Regulation (EC) No 1831/2003 of the European Parliament and of the Council (20) confer respectively on the European Union reference laboratory for genetically modified food and feed and on the European Union reference laboratory for feed additives specific tasks as part of the authorisation procedure for genetically modified food or feed, or feed additives, relating, in particular, to the testing, evaluation and validation of the method of detection or analysis proposed by applicants. Those laboratories therefore should act as European Union reference laboratories for the purposes of this Regulation.

For the performance of official controls and other official activities which are aimed at identifying possible violations to the rules including those perpetrated through fraudulent or deceptive practices, and in the field of animal welfare, the competent authorities should have access to updated, reliable and consistent technical data, to research findings, new techniques and expertise necessary for the correct application of Union legislation applicable in those two areas. For that purpose, the Commission should be able to designate, and rely on the expert assistance of, European Union reference centres for the authenticity and integrity of the agri-food chain and for animal welfare.

In order to pursue the objectives of this Regulation and contribute to the smooth functioning of the internal market, ensuring consumer confidence in it, cases of non-compliance with Union agri-food chain legislation requiring enforcement action in more than one Member State should be pursued efficiently and consistently. The Rapid Alert System for Food and Feed (RASFF) established pursuant to Article 50 of Regulation (EC) No 178/2002 already enables competent authorities to rapidly exchange and disseminate information on serious direct or indirect risks to human health in relation to food or feed, or serious risks to human or animal health or to the environment in relation to feed, for the purpose of enabling rapid measures to be taken to counter those serious risks. However, that instrument, while allowing for timely action across all Member States concerned to counter certain serious risks along the agri-food chain, cannot serve the purpose of enabling effective cross border assistance and cooperation between competent authorities to ensure that cases of non-compliance with Union agri-food chain legislation which have a cross-border dimension are effectively pursued not only in the Member State where the non-compliance is first detected but also in the Member State where the non-compliance originated. In particular, administrative assistance and cooperation should enable competent authorities to share information, detect, investigate and take effective and proportionate action to pursue cross-border violations of Union agri-food chain legislation also in cases where potential fraudulent or deceptive practices have or could have a cross-border dimension.

Requests for administrative assistance and all notifications should be given appropriate follow-up. In order to facilitate administrative assistance and cooperation, Member States should be required to designate one or more liaison bodies to assist and coordinate communication flows between competent authorities in different Member States. In order to ensure uniform conditions for the implementation of this Regulation and to streamline and simplify cooperation between Member States, implementing powers should be conferred on the Commission to adopt implementing acts establishing the specifications of the technical tools to be used, the procedures for communication between liaison bodies and a standard format for requests for assistance, notifications and responses.

Each Member State should be required to set up and regularly update a multi-annual national control plan (MANCP) covering all the areas governed by Union agri-food chain legislation and containing information on the structure and organisation of its system of official controls. Such MANCPs are the instrument through which each Member State should ensure that official controls are performed in a manner that is risk-based and efficient across their territory and across the entire agri-food chain, and in compliance with this Regulation. Appropriate consultation with relevant stakeholders in advance of the preparation of the plans should ensure their fitness for purpose.

In order to ensure the coherence and completeness of the MANCP each Member State should designate a single body tasked with coordinating the preparation of its MANCP and collecting, as necessary, the information on its implementation, review and update.

Member States should be required to submit an annual report to the Commission with information on control activities and the implementation of the MANCPs. In order to ensure uniform conditions for the implementation of this Regulation and to facilitate the collection and transmission of comparable data, the subsequent compilation of such data into Union-wide statistics and the preparation of reports by the Commission on the operation of official controls across the Union, implementing powers should be conferred on the Commission to adopt implementing acts in respect of establishing standard model forms for annual reports.

Commission experts should be able to perform controls, including audits, in Member States to verify the application of the relevant Union legislation and the functioning of national control systems and competent authorities. Commission controls should also serve to investigate and collect information on enforcement practices or problems, emergencies and new developments in Member States. At the request of the Member States concerned, Commission experts should also be able to participate in controls performed by the competent authorities of third countries on the territory of that Member State; such controls should be organised in close cooperation between the Member States concerned and the Commission.

Animals and goods from third countries should comply with the same requirements which apply to Union animals and goods, or with requirements which are recognised to be at least equivalent in relation to the objectives pursued by Union agri-food chain legislation. This principle is enshrined in Article 11 of Regulation (EC) No 178/2002, which requires that food and feed imported into the Union comply with the relevant requirements of the Union's food law or with requirements considered to be at least equivalent thereto. Specific requirements to apply that principle are provided for in Union rules on protective measures against pests of plants, which prohibit the introduction into the Union of certain pests which are not present (or only present to a limited extent) in the Union, in Union rules laying down animal health requirements, which allow the entry of animals and of certain products of animal origin into the Union only from third countries which are included in a list set up for that purpose, and in Union rules for the organisation of official controls on products of animal origin intended for human consumption, which also provide for the establishment of a list of third countries from which those products can enter the Union.

In order to ensure that animals and goods entering the Union from third countries comply with all the requirements laid down in Union agri-food chain legislation or with requirements considered equivalent, in addition to the requirements established by Union rules on protective measures against pests of plants, Union rules laying down animal health requirements and Union rules laying down specific hygiene rules for food of animal origin to ensure that the requirements laid down in Union agri-food chain legislation in relation to phytosanitary and veterinary concerns are met, the Commission should be allowed to establish conditions for the entry of animals and goods into the Union to the extent necessary to ensure that those animals and goods comply with all relevant requirements of Union agri-food chain legislation or equivalent requirements. Such conditions should apply to animals or goods or categories of animals or goods from all third countries or from certain third countries or regions thereof.

Where, in specific cases, there is evidence that certain animals or goods originating from a third country, a group of third countries, or regions thereof, give rise to risks to human, animal or plant health or, as regards GMOs and plant protection products, also to the environment or where there is evidence that widespread serious non-compliance with Union agri-food chain legislation might be taking place, the Commission should be able to adopt measures to contain such risks.

The performance of effective and efficient official controls and other official activities, and ultimately the safety and health of humans, animals and plants, and the protection of the environment, also depends on the availability to the control authorities of well trained staff possessing an appropriate knowledge of all the matters relevant for the correct application of Union legislation. Appropriate and dedicated training should be provided by the Commission to promote a uniform approach to official controls and other official activities by the competent authorities. To promote the knowledge of Union agri-food chain legislation and requirements in third countries, such training should also be addressed to staff of the competent authorities in third countries. In the latter case, the training activities should be designed to take into account the specific needs of developing countries, to support their controls and enforcement actions so that they can meet the requirements applicable to import of animals and goods into the Union.

To promote the sharing of experience and best practices among competent authorities, the Commission should also be able to organise, in cooperation with the Member States, programmes for the exchange between Member States of staff tasked with official controls or other official activities.

It is important for the performance of effective official controls and other official activities that the competent authorities in the Member States, the Commission and, where relevant, operators be able to exchange data and information related to official controls or results therefrom rapidly and efficiently. Several information systems are established by Union legislation and managed by the Commission to allow such data and information to be handled and managed through Union-wide computerised and internet-based tools. A system dedicated to recording and tracing official control results is the Trade Control and Expert System (Traces system), established by Commission Decisions 2003/24/EC (21) and 2004/292/EC (22) in accordance with Council Directive 90/425/EEC (23) and currently used for the management of data and information on animals and products of animal origin and official controls thereon. This Regulation should allow that system to be maintained and upgraded so as to allow its use for all goods for which Union agri-food chain legislation establishes specific requirements or practical arrangements for official controls.Dedicated computerised systems also exist for the rapid exchange of information between Member States and with the Commission on risks which might arise in the agri-food chain or for animal and plant health. Article 50 of Regulation (EC) No 178/2002 establishes the RASFF which is a system for notifying direct or indirect risk to human health deriving from food or feed, Article 20 of Regulation (EU) 2016/429 of the European Parliament and of the Council (24) a system for the notification and reporting on the measures on listed diseases, and Article 103 of Regulation (EU) 2016/2031 of the European Parliament and of the Council (25) a system for the notification and reporting of the presence of pests and the notification of cases of non-compliance. All such systems should work in a harmonious and consistent manner that makes use of synergies between the different systems, avoids duplications, simplifies their operation and makes them more efficient.

To support a more efficient management of official controls, a computerised information system integrating and upgrading as necessary all relevant existing information systems should be set up by the Commission, allowing for the use of advanced communication and certification tools, and for the most efficient use of the data and information related to official controls. In view of avoiding unnecessary duplications of information requirements, the design of such computerised system should take into account the need to ensure, wherever appropriate, the compatibility and inter-operability of such a computerised system with other information systems operated by public authorities and through which relevant data is automatically exchanged or made available. Moreover, the possibility to use electronic signatures within the meaning of Directive 1999/93/EC of the European Parliament and the Council (26) should be provided for, in line with the Digital Agenda for Europe. The European Data Protection Supervisor should be consulted during the development stage of any new functionality of such computerised system, as well as during the development of relevant implementing measures which might affect the processing of personal data and privacy.

In order to ensure uniform conditions for the implementation of this Regulation regarding the proper functioning of the computerised information system, its technical specifications, as well as the duties and prerogatives of the various actors and users involved, taking into account in particular the need to minimise administrative burdens by using, as appropriate, internationally standardised language, message structure and exchange protocols, implementing powers should be conferred on the Commission.

The competent authorities should investigate cases where there is a suspicion of non-compliance with Union agri-food chain legislation and, where non-compliance is established, determine its origin and extent as well as the operators’ responsibilities. The competent authorities should also take appropriate measures to ensure that the operators concerned remedy the situation and to prevent further non-compliance. The organisation and performance of investigations and enforcement actions by the competent authorities should duly take into account potential risks and the likelihood of fraudulent or deceptive practices along the agri-food chain.

The verification of compliance with Union agri-food chain legislation through official controls is of fundamental importance to ensure that, across the Union, the objectives of that legislation are effectively achieved. Disruptions in a Member State’s control systems can in certain cases substantially hinder the achievement of those objectives and lead to the emergence of risks to human, animal and plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, independently of the involvement or responsibility of operators or other actors, or lead to situations of widespread serious non-compliance with Union agri-food chain legislation. In order to ensure uniform conditions for the implementation of this Regulation, the Commission should be able, in the event of serious disruptions in a Member State’s control system, to react by adopting measures aimed at containing or eliminating those risks from the agri-food chain, pending the necessary action to be taken by the Member State concerned to remedy the disruption in the control system. Implementing powers should therefore be conferred on the Commission.

Infringements of the rules of the Union agri-food chain legislation and of this Regulation should be subject to effective, dissuasive and proportionate penalties at national level throughout the Union, the severity of which takes account, inter alia, of the potential damage to human health that may result from infringements, including in cases where operators fail to cooperate during an official control and in cases where false or misleading official certificates or attestations are produced or used. For financial penalties applicable to violations of the rules perpetrated through fraudulent or deceptive practices to be sufficiently deterrent, they should be set at a level which seeks to exceed the undue advantage for the perpetrator resulting from those practices.

Any person should be able to bring new information to the attention of competent authorities which assists them in detecting, and imposing penalties in cases of, infringements of this Regulation and of the rules referred to in Article 1(2). However, whistleblowing could be deterred by the lack of clear procedures or for fear of retaliation. Reporting of infringements of this Regulation is a useful tool to ensure that a competent authority is able to detect and impose penalties for infringements. This Regulation should therefore ensure that adequate arrangements are in place to enable any person to alert the competent authorities to possible infringements of this Regulation and to protect that person from retaliation.

This Regulation covers areas that are already covered in certain acts currently in force. To avoid duplications and to establish a coherent legislative framework, the following acts should be repealed and replaced by this Regulation: Regulation (EC) No 882/2004 and Regulation (EC) No 854/2004 of the European Parliament and of the Council (27), Council Directives 89/608/EEC (28), 89/662/EEC (29), 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC (30) and 97/78/EC and Council Decision 92/438/EEC (31).

In order to ensure consistency, the following acts should be amended: Regulation (EC) No 999/2001 of the European Parliament and of the Council (32), Council Regulation (EC) No 1/2005 (33), Regulation (EC) No 396/2005 of the European Parliament and of the Council (34), Regulation (EC) No 1069/2009, Council Regulation (EC) No 1099/2009 (35), Regulation (EC) No 1107/2009 of the European Parliament and of the Council (36), Regulation (EU) No 1151/2012 of the European Parliament and of the Council (37), and Council Directives 98/58/EC (38), 1999/74/EC (39), 2007/43/EC (40), 2008/119/EC (41) and 2008/120/EC (42).

Regulation (EU) No 652/2014 of the European Parliament and of the Council (43) provides a framework for the Union’s financing of actions and measures across the agri-food chain in those areas under the multi-annual financial framework 2014-2020. Some of those acts and measures aim to improve the performance of official controls and other official activities across the Union. Regulation (EU) No 652/2014 should be amended to take account of the repeal of Regulation (EC) No 882/2004 by this Regulation.

Considering the specific situation as regards the plant sector, which has so far not been subject to the same level of controls as other goods under this Regulation, it is essential that the introduction of the new system be as smooth and seamless as possible. For that reason, it is necessary to introduce specific provisions regarding the timing of the adoption of relevant delegated acts. It is also clear that it is justified to have an exemption from the obligation of documentary checks to be carried out at border control posts for the plant sector in the case of plants, plant products and other objects posing a low level of risk and to permit documentary checks at a distance from border control posts for plants, plant products and other objects where such checks at a distance are able to provide an equal level of assurance.

In order to amend the references to European standards, and Annexes II and III to this Regulation to take into account of legislative and technical and scientific developments, and to supplement this Regulation with specific rules governing official controls and other official activities in the areas it covers, including rules on the qualification and training of staff, on additional responsibilities and tasks of the competent authorities, on the cases where the accreditation of laboratories is not required, on certain exemptions from official controls at the borders, on the criteria to be used to determine the frequency of identity checks and physical checks, on the establishment of conditions to be fulfilled by certain animals or goods entering the Union from third countries, on additional requirements and tasks of European Union reference laboratories and centres and on additional requirements for national reference laboratories, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (44). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

In order to ensure uniform conditions for the implementation of this Regulation regarding the designation of European Union reference laboratories and of the European Union reference centres for the authenticity and integrity of the agri-food chain and for animal welfare, the adoption of the programme of the Commission controls in the Member States, and the performance of increased official controls in the event of infringements of Union agri-food chain legislation which require coordinated assistance and follow-up by the Commission, implementing powers should be conferred on the Commission.

In order to ensure uniform conditions for the implementation of this Regulation, including rules and practical arrangements in respect of audits, the format of certificates and other documents, the establishment of computerised information management systems, the cooperation between operators and competent authorities and amongst competent authorities, customs authorities and other authorities, the methods of sampling and of laboratory analysis, test and diagnosis as well as their validation and interpretation, traceability, the listing of animals or goods subject to controls as well the listing of countries or regions that can export certain animals and goods to the Union, prior notification of consignments, exchanges of information, border control posts, isolation and quarantine, approval of pre-export controls performed by third countries, measures to contain a risk or put an end to a widespread serious non-compliance relating to certain animals or goods originating from a third country or a region thereof, the recognition of third countries or regions that offer equivalent guarantees to those applied in the Union and its repeal, training activities and exchange programmes of staff amongst Member States and on the contingency plans for food and feed for the application of the general plan for crisis management provided for in Article 55(1) of Regulation (EC) No 178/2002, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (45).

Since the objective of this Regulation, namely to ensure a harmonised approach with regard to official controls and other official activities performed in view of ensuring the application of Union agri-food chain legislation, cannot be sufficiently achieved by the Member States but can rather, by reason of its effect, complexity, trans-border and international character, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,

the performance of official controls and other official activities by the competent authorities of the Member States;

the financing of official controls;

the administrative assistance and cooperation between Member States in view of the correct application of the rules referred to in paragraph 2;

the performance of controls by the Commission in Member States and in third countries;

the adoption of conditions to be fulfilled with respect to animals and goods entering the Union from a third country;

the establishment of a computerised information system to manage information and data in relation to official controls.

food and food safety, integrity and wholesomeness at any stage of production, processing and distribution of food, including rules aimed at ensuring fair practices in trade and protecting consumer interests and information, and the manufacture and use of materials and articles intended to come into contact with food;

deliberate release into the environment of Genetically Modified Organisms (GMOs) for the purpose of food and feed production;

feed and feed safety at any stage of production, processing and distribution of feed and the use of feed, including rules aimed at ensuring fair practices in trade and protecting consumer health, interests and information;

animal health requirements;

prevention and minimisation of risks to human and animal health arising from animal by-products and derived products;

welfare requirements for animals;

protective measures against pests of plants;

requirements for the placing on the market and use of plant protection products and the sustainable use of pesticides, with the exception of pesticides application equipment;

organic production and labelling of organic products;

use and labelling of protected designations of origin, protected geographical indications and traditional specialities guaranteed.

Regulation (EU) No 1308/2013; however, this Regulation shall apply to checks pursuant to Article 89 of Regulation (EU) No 1306/2013, where those checks identify possible fraudulent or deceptive practices in respect of the marketing standards referred to in Articles 73 to 91 of Regulation (EU) No 1308/2013;

Directive 2010/63/EU of the European Parliament and of the Council (46);

Directive 2001/82/EC of the European Parliament and of the Council (47).

compliance by the operators with this Regulation and with the rules referred to in Article 1(2); and

that animals or goods meet the requirements laid down in the rules referred to in Article 1(2), including for the issuance of an official certificate or official attestation.

‘food law’ means food law as defined in point (1) of Article 3 of Regulation (EC) No 178/2002;

‘feed law’ means the laws, regulations and administrative provisions governing feed in general and feed safety in particular, whether at Union or national level at any stage of production, processing and distribution or use of feed;

‘competent authorities’ means:

‘organic control authority’ means a public administrative organisation for organic production and labelling of organic products of a Member State to which the competent authorities have conferred, in whole or in part, their competences in relation to the application of Council Regulation (EC) No 834/2007 (48), including, where appropriate, the corresponding authority of a third country or operating in a third country;

‘delegated body’ means a separate legal person to which the competent authorities have delegated certain official control tasks or certain tasks related to other official activities;

‘control verification procedures’ means the arrangements put in place and actions performed by the competent authorities for the purpose of ensuring that official controls and other official activities are consistent and effective;

‘control system’ means a system comprising the competent authorities and the resources, structures, arrangements and procedures set up in a Member State to ensure that official controls are performed in accordance with this Regulation and with the rules referred to in Articles 18 to 27;

‘control plan’ means a description established by the competent authorities containing information on the structure and organisation of the official control system, and of its operation and the detailed planning of official controls to be performed, over a period of time, in each of the areas governed by the rules referred to in Article 1(2);

‘animals’ means animals as defined in point (1) of Article 4 of Regulation (EU) 2016/429;

‘animal disease’ means disease as defined in point (16) of Article 4 of Regulation (EU) 2016/429;

‘goods’ means all that is subject to one or more of the rules referred to in Article 1(2), excluding animals;

‘food’ means food as defined in Article 2 of Regulation (EC) No 178/2002;

‘feed’ means feed as defined in point (4) of Article 3 of Regulation (EC) No 178/2002;

‘animal by-products’ means animal by-products as defined in point (1) of Article 3 of Regulation (EC) No 1069/2009;

‘derived products’ means derived products as defined in point (2) of Article 3 of Regulation (EC) No 1069/2009;

‘plants’ means plants as defined in point (1) of Article 2 of Regulation (EU) 2016/2031;

‘pests of plants’ means pests as defined in Article 1(1) of Regulation (EU) 2016/2031;

‘plant protection products’ means plant protection products as referred to in Article 2(1) of Regulation (EC) No 1107/2009;

‘products of animal origin’ means products of animal origin as defined in point 8.1 of Annex I to Regulation (EC) No 853/2004 of the European Parliament and of the Council (49);

‘germinal products’ means germinal products as defined in point (28) of Article 4 of Regulation (EU) 2016/429;

‘plant products’ means plant products as defined in point (2) of Article 2 of Regulation (EU) 2016/2031;

‘other objects’ means other objects as defined in point (5) of Article 2 of Regulation (EU) 2016/2031;

‘hazard’ means any agent or condition with the potential to have an adverse effect on human, animal or plant health, animal welfare or the environment;

‘risk’ means a function of the probability of an adverse effect on human, animal or plant health, animal welfare or the environment and of the severity of that effect, consequential to a hazard;

‘official certification’ means the procedure by which assurance concerning compliance with one or more requirements laid down in the rules referred to in Article 1(2) is provided by the competent authorities;

‘certifying officer’ means:

‘official certificate’ means a paper or electronic document signed by the certifying officer and providing assurance concerning compliance with one or more requirements laid down in the rules referred to in Article 1(2);

‘official attestation’ means any label, mark or other form of attestation issued by the operators under the supervision, through dedicated official controls, of the competent authorities or by the competent authorities themselves, and providing assurance concerning compliance with one or more requirements laid down in this Regulation or in the rules referred to in Article 1(2);

‘operator’ means any natural or legal person subject to one or more of the obligations provided for in the rules referred to in Article 1(2);

‘audit’ means a systematic and independent examination to determine whether activities and the related results of such activities comply with planned arrangements and whether these arrangements are applied effectively and are suitable to achieve the objectives;

‘rating’ means a classification of operators based on an assessment of their conformity with rating criteria;

‘official veterinarian’ means a veterinarian appointed by a competent authority, either as staff or otherwise, and appropriately qualified to perform official controls and other official activities in accordance with this Regulation and the relevant rules referred to in Article 1(2);

‘official plant health officer’ means a natural person appointed by a competent authority, either as staff or otherwise, and appropriately trained to perform official controls and other official activities in accordance with this Regulation and the relevant rules referred to in point (g) of Article 1(2);

‘specified risk material’ means specified risk material as defined in point (g) of Article 3(1) of Regulation (EC) No 999/2001;

‘long journey’ means a long journey as defined in point (m) of Article 2 of Regulation (EC) No 1/2005;

‘pesticide application equipment’ means pesticide application equipment as defined in point (4) of Article 3 of Directive 2009/128/EC;

‘consignment’ means a number of animals or quantity of goods covered by the same official certificate, official attestation or any other document, conveyed by the same means of transport and coming from the same territory or third country, and, except for goods subject to the rules referred to in point (g) of Article 1(2), being of the same type, class or description;

‘border control post’ means a place, and the facilities belonging to it, designated by a Member State for the performance of the official controls provided for in Article 47(1);

‘exit point’ means a border control post or any other place designated by a Member State where animals, falling within the scope of Regulation (EC) No 1/2005, leave the customs territory of the Union;

‘entering the Union’ or ‘entry into the Union’ means the action of bringing animals and goods into one of the territories that are listed in Annex I to this Regulation from outside these territories, except in relation to the rules referred to in point (g) of Article 1(2) for which these terms mean the action of bringing goods into the ‘Union territory’ as defined in the second subparagraph of Article 1(3) of Regulation (EU) 2016/2031;

‘documentary check’ means the examination of the official certificates, official attestations and other documents including documents of a commercial nature, which are required to accompany the consignment as provided for by the rules referred to in Article 1(2), by Article 56(1) or by implementing acts adopted in accordance with Articles 77(3), 126(3), 128(1) and 129(1);

‘identity check’ means a visual inspection to verify that the content and the labelling of a consignment, including the marks on animals, seals and means of transport, correspond to the information provided in the official certificates, official attestations and other documents accompanying it;

‘physical check’ means a check on animals or goods and, as appropriate, checks on packaging, the means of transport, labelling and temperature, the sampling for analysis, testing or diagnosis and any other check necessary to verify compliance with the rules referred to in Article 1(2);

‘transit’ means movement from one third country to another third country passing under customs supervision through one of the territories listed in Annex I or from one of the territories listed in Annex I to another territory listed in Annex I after passing through the territory of a third country, except in relation to the rules referred to in point (g) of Article 1(2), for which it means one of the following;

‘supervision by the customs authorities’ means customs supervision as defined in point (27) of Article 5 of Regulation (EU) No 952/2013 of the European Parliament and of the Council (50);

‘control by the customs authorities’ means customs controls as defined in point (3) of Article 5 of Regulation (EU) No 952/2013;

‘official detention’ means the procedure by which the competent authorities ensure that animals and goods subject to official controls are not moved or tampered with pending a decision on their destination; it includes storage by operators in accordance with the instructions and under the control of the competent authorities;

‘journey log’ means the document set out in points 1 to 5 of Annex II to Regulation (EC) No 1/2005;

‘official auxiliary’ means a representative of the competent authorities trained in accordance with the requirements established under Article 18 and employed to perform certain official control tasks or certain tasks related to other official activities;

‘meat and edible meat offal’ means, for the purpose of point (a) of Article 49(2) of this Regulation, the products listed in sub-Chapters 0201 to 0208 of Chapter 2 of Section I of Part II of Annex I to Council Regulation (EEC) No 2658/87 (51);

‘health mark’ means a mark applied after the official controls referred to in points (a) and (c) of Article 18(2) have been performed and which attests that the meat is fit for human consumption.

ensure efficient and effective coordination between all authorities involved, and the consistency and effectiveness of official controls or other official activities across its territory; and

designate a single authority, in conformity with Member States’ constitutional requirements, responsible for coordinating the cooperation and the contacts with the Commission and with other Member States in relation to the official controls and other official activities performed in each of the areas governed by the rules referred to in Article 1(2).

the competent authorities designated in accordance with paragraph 1;

the single authorities designated in accordance with point (b) of paragraph 2;

the organic control authorities referred to in paragraph 3;

the delegated bodies referred to in Article 28(1).

have procedures and/or arrangements in place to ensure the effectiveness and appropriateness of official controls and other official activities;

have procedures and/or arrangements in place to ensure the impartiality, quality and consistency of official controls and other official activities at all levels;

have procedures and/or arrangements in place to ensure that staff performing official controls and other official activities are free from any conflict of interest;

have, or have access to, an adequate laboratory capacity for analysis, testing and diagnosis;

have, or have access to, a sufficient number of suitably qualified and experienced staff so that official controls and other official activities can be performed efficiently and effectively;

have appropriate and properly maintained facilities and equipment to ensure that staff can perform official controls and other official activities efficiently and effectively;

have the legal powers to perform official controls and other official activities and to take the action provided for in this Regulation and in the rules referred to in Article 1(2);

have legal procedures in place in order to ensure that staff have access to the premises of, and documents kept by, operators so as to be able to accomplish their tasks properly;

have contingency plans in place, and be prepared to operate such plans in the event of an emergency, where appropriate, in accordance with the rules referred to in Article 1(2).

receive, for their area of competence, appropriate training enabling them to undertake their duties competently and to perform official controls and other official activities in a consistent manner;

keep up-to-date in their area of competence and receive regular additional training as necessary; and

receive training in the subject matters set out in Chapter I of Annex II and on the obligations of the competent authorities resulting from this Regulation, as appropriate.

the purpose of inspections, investigations or audits;

the protection of commercial interests of an operator or any other natural or legal person; or

the protection of court proceedings and legal advice.

the operator concerned is given the opportunity to comment on the information that the competent authority intends to publish or make otherwise available to the public, prior to its publication or release, taking into account the urgency of the situation; and

the information which is published or made otherwise available to the public takes into account the comments expressed by the operator concerned or is published or released together with such comments.

identified risks associated with:

any information indicating the likelihood that consumers might be misled, in particular as to the nature, identity, properties, composition, quantity, durability, country of origin or place of provenance, method of manufacture or production of food;

operators’ past record as regards the outcome of official controls performed on them and their compliance with the rules referred to in Article 1(2);

the reliability and results of own controls that have been performed by the operators, or by a third party at their request, including, where appropriate, private quality assurance schemes, for the purpose of ascertaining compliance with the rules referred to in Article 1(2); and

any information that might indicate non-compliance with the rules referred to in Article 1(2).

the rules referred to in Article 1(2);

the applicable delegated and implementing acts adopted by the Commission in accordance with Articles 18 to 27.

available on the Union market, whether originating in the Member State where the official controls are performed or in another Member State;

to be exported from the Union; or

entering the Union.

animals and goods at any stage of production, processing, distribution and use;

substances, materials or other objects which may influence the characteristics or health of animals and goods and their compliance with applicable requirements, at any stage of production, processing, distribution and use;

operators as regards activities, including the keeping of animals, equipment, means of transport, premises and other places under their control and their surroundings and on related documentation.

the type, number and outcome of official controls;

the type and number of cases of non-compliance detected;

the type and number of cases where measures were taken by the competent authorities in accordance with Article 138; and

the type and number of cases where the penalties referred to in Article 139 were imposed.

the rating criteria are objective, transparent and publicly available; and

appropriate arrangements are in place to ensure the fairness, consistency and transparency of the rating process.

take corrective actions in all cases where the procedures provided for in paragraph 2 identify shortcomings; and

update the documented procedures provided for in paragraph 1 as appropriate.

a description of the purpose of the official controls;

the control methods applied;

the outcome of the official controls; and

where appropriate, action that the competent authorities require the operator concerned to take as a result of their official controls.

regularly informed of the level of compliance; and

promptly informed of any case of non-compliance identified through the official controls.

an examination of the controls that operators have put in place and of the results obtained;

an inspection of:

controls on the hygiene conditions in the operators’ premises;

an assessment of procedures on good manufacturing practices, good hygiene practices, good farming practices, and of procedures based on the principles of hazard analysis critical control points (HACCP);

an examination of documents, traceability records and other records which may be relevant to the assessment of compliance with the rules referred to in Article 1(2), including, where appropriate, documents accompanying food, feed and any substance or material entering or leaving an establishment;

interviews with operators and with their staff;

the verification of measurements taken by the operator and other test results;

sampling, analysis, diagnosis and tests;

audits of operators;

any other activity required to identify cases of non-compliance.

the equipment, means of transport, premises and other places under their control and their surroundings;

their computerised information management systems;

the animals and goods under their control;

their documents and any other relevant information.

their name and legal form; and

the specific activities they carry out, including activities undertaken by means of distance communication, and the places under their control.

the experience gained by competent authorities and food and feed business operators when applying the procedures referred to in Article 5 of Regulation (EC) No 852/2004 of the European Parliament and of the Council (52) and Article 6 of Regulation (EC) No 183/2005 of the European Parliament and of the Council (53);

scientific and technological developments;

consumer expectations with regard to food composition and changes in patterns of consumption of food;

risks to human and animal health and plant health associated with animals and goods; and

information on possible intentional violations perpetrated through fraudulent or deceptive practices.

the need to facilitate the application of the delegated acts and implementing acts, taking into account the nature and the size of small businesses;

the need to enable the continued use of traditional methods at any stage of production, processing or distribution of food, and the production of traditional foods; and

the needs of operators situated in regions that are subject to specific geographical constraints.

‘under the responsibility of the official veterinarian’ means that the official veterinarian assigns the performance of an action to an official auxiliary;

‘under the supervision of the official veterinarian’ means that an action is performed by an official auxiliary under the responsibility of the official veterinarian and the official veterinarian is present on the premises during the time necessary to perform that action;

‘ante-mortem inspection’ means the verification, prior to slaughtering activities, of human and animal health and animal welfare requirements, including, where appropriate, the clinical examination of each individual animal, and the verification of the food chain information as referred to in Section III of Annex II to Regulation (EC) No 853/2004;

‘post-mortem inspection’ means the verification in the slaughterhouse or game-handling establishment of compliance with requirements applicable to:

the ante-mortem inspection performed in the slaughterhouse by an official veterinarian who may, as regards pre-selection of animals, be assisted by official auxiliaries trained for that purpose;

by way of derogation from point (a), as regards poultry and lagomorphs, the ante-mortem inspection performed by an official veterinarian, under the supervision of the official veterinarian or, where sufficient guarantees are in place, under the responsibility of the official veterinarian;

the post-mortem inspection performed by an official veterinarian, under the supervision of the official veterinarian or, where sufficient guarantees are in place, under the responsibility of the official veterinarian;

the other official controls performed in slaughterhouses, cutting plants and game-handling establishments, by an official veterinarian, under the supervision of the official veterinarian or, where sufficient guarantees are in place, under the responsibility of the official veterinarian, to verify compliance with the requirements applicable to:

act independently from the production staff of the slaughterhouse;

have undergone appropriate training to carry out these tasks; and

carry out these tasks in the presence and following the instructions of the official veterinarian or of the official auxiliary.

criteria and conditions to determine, by way of derogation from point (a) of paragraph 2, when the ante-mortem inspection in certain slaughterhouses may be performed under the supervision or under the responsibility of an official veterinarian, provided that the derogations do not affect the achievement of the objectives of this Regulation;

criteria and conditions to determine, as regards poultry and lagomorphs, when sufficient guarantees are met for the official controls to be performed under the responsibility of an official veterinarian in regard to the ante-mortem inspections referred to in point (b) of paragraph 2;

criteria and conditions to determine, by way of derogation from point (a) of paragraph 2, when the ante-mortem inspection may be performed outside the slaughterhouse in case of emergency slaughter;

criteria and conditions to determine, by way of derogation from points (a) and (b) of paragraph 2, when the ante-mortem inspection may be performed at the holding of provenance;

criteria and conditions to determine when sufficient guarantees are met for the official controls to be performed under the responsibility of an official veterinarian with regard to the post-mortem inspection and auditing activities referred to in points (c) and (d) of paragraph 2;

criteria and conditions to determine, by way of derogation from point (c) of paragraph 2, when, in case of emergency slaughter, the post-mortem inspection is to be performed by the official veterinarian;

criteria and conditions to determine, in relation to Pectinidae, marine gastropods and Holothuroidea, by way of derogation from paragraph 6, when production and relaying areas are not to be classified;

specific derogations in respect to Rangifer tarandus tarandus, Lagopus lagopus and Lagopus mutus, in order to allow the continuation of longstanding local and traditional customs and practices, provided that the derogations do not affect the achievement of the objectives of this Regulation;

criteria and conditions to determine, by way of derogation from point (d) of paragraph 2, when the official controls in cutting plants may be performed by staff designated by the competent authorities for that purpose and appropriately trained;

specific minimum requirements for the staff of the competent authorities and for official veterinarian and official auxiliary in order to ensure an adequate performance of their tasks provided for in this Article, including specific minimum training requirements;

appropriate minimum training requirements for the slaughterhouse staff assisting in the performance of tasks relating to official controls and other official activities in accordance with paragraph 3.

specific requirements for the performance of official controls and the uniform minimum frequency of those official controls, having regard to the specific hazards and risks which exist in relation to each product of animal origin and the different processes it undergoes, where a minimum level of official controls is necessary to respond to recognised uniform hazards and risks which might be posed by products of animal origin;

the conditions for the classification and monitoring of classified production and relaying areas for live bivalve molluscs;

the cases where the competent authorities in relation to specific non-compliances are to take one or more of the measures referred to in Articles 137(2) and 138(2);

the practical arrangements of the ante-mortem and post-mortem inspections referred to in points (a), (b) and (c) of paragraph 2, including the uniform requirements necessary to ensure that sufficient guarantees are met when the official controls are performed under the responsibility of the official veterinarian;

the technical requirements of the health mark and the practical arrangements for its application;

specific requirements for the performance of official controls and the uniform minimum frequency for those official controls on raw milk, milk products and fishery products, where a minimum level of official controls is necessary to respond to recognised uniform hazards and risks they might pose.

specific requirements for the performance of official controls, including, where appropriate, the range of samples and the stage of production, processing and distribution where the samples are to be taken in compliance with the methods to be used for sampling and laboratory analyses established in accordance with points (a) and (b) of Article 34(6), having regard to the specific hazards and risks related to substances referred to in paragraph 1 of this Article;

the cases where the competent authorities in relation to non-compliance or suspicion thereof are to take one or more of the measures referred to in Articles 137(2) and 138(2);

the cases where the competent authorities in relation to non-compliance or suspicion thereof of animals and goods from third countries are to take one or more of the measures referred to Articles 65 to 72.

uniform minimum frequency of such official controls, having regard to the hazards and risks related to substances referred to in paragraph 1;

specific additional arrangements and specific additional content to those provided for in Article 110, for the preparation of the relevant parts of the multi-annual national control plan (MANCP) provided for in Article 109(1);

specific practical arrangements for the activation of the mechanism of administrative assistance provided for in Articles 102 to 108.

specific requirements for the performance of official controls on animals, products of animal origin and germinal products to respond to recognised hazards and risks to human and animal health by means of official controls performed to verify compliance with disease prevention and control measures laid down in accordance with the rules referred to in point (d) of Article 1(2);

specific requirements for the performance of official controls on animal by-products and derived products to respond to specific hazards and risks to human and animal health by means of official controls performed to verify compliance with the rules referred to in point (e) of Article 1(2);

the cases where the competent authorities in relation to non-compliance or suspicion thereof are to take one or more of the measures referred to in Articles 137(2) and 138(2).

uniform minimum frequency of such official controls on animals, products of animal origin and germinal products where a minimum level of official controls is necessary to respond to recognised uniform hazards and risks to human and animal health by means of official controls performed to verify compliance with disease prevention and control measures laid down in accordance with the rules referred to in point (d) of Article 1(2); and

uniform minimum frequency of such official controls on animal-by-products and derived products where a minimum level of official controls is necessary to respond to specific hazards and risks to human and animal health by means of official controls performed to verify compliance with the rules referred to in point (e) of Article 1(2).

in the case of long journeys between Member States and with third countries, official controls performed prior to the loading to check the fitness of the animals for transport;

in the case of long journeys between Member States and with third countries, of domestic equidae other than registered equidae and domestic animals of the bovine, ovine, caprine and porcine species, and prior to those journeys:

at border control posts provided for in Article 59(1) and at exit points:

to the Member States that granted the authorisation to the transporter;

where non-compliance with any such rule applicable to the means of transport is identified, to the Member State that granted the certificate of approval of the means of transport;

where non-compliance with any such rule applicable to drivers is identified, to the Member State that issued the driver’s certificate of competence.

specific requirements for the performance of such official controls to respond to the risk associated with different animal species and means of transport, and the need to prevent non-compliant practices and to limit the suffering of animals;

the cases where the competent authorities in relation to specific non-compliances are to take one or more of the measures referred to in Articles 137(2) and 138(2);

the verification of animal welfare requirements at border control posts and at exit points and the minimum requirements applicable to those exit points;

specific criteria and conditions for the activation of the mechanisms of administrative assistance provided for in Articles 102 to 108;

the cases and conditions where official controls to verify compliance with animal welfare requirements may include the use of specific animal welfare indicators based on measurable performance criteria, and the design of such indicators on the basis of scientific and technical evidence.

uniform minimum frequency of such official controls, where a minimum level of official control is necessary to respond to the risk associated with different animal species and means of transport, and the need to prevent non-compliant practices and to limit the suffering of animals; and

the practical arrangements for keeping written records of official controls performed and their retention period.

specific requirements for the performance of such official controls on the introduction into and movement in the Union of particular plants, plant products, and other objects subject to the rules referred to in point (g) of Article 1(2), to respond to recognised hazards and risks to plant health in relation to specific plants, plant products and other objects of a particular origin or provenance; and

the cases where the competent authorities in relation to specific non-compliances are to take one or more of the measures referred to in Articles 137(2) and 138(2).

uniform minimum frequency of such official controls, where a minimum level of official control is necessary to respond to recognised uniform hazards and risks to plant health in relation to specific plants, plant products and other objects of a particular origin or provenance;

uniform frequency of official controls performed by competent authorities on operators authorised to issue plant passports in accordance with Article 84(1) of Regulation (EU) 2016/2031 having regard to whether those operators have implemented a pest risk management plan as referred to in Article 91 of that Regulation for the plants, plant products and other objects they produce;

uniform frequency of official controls performed by competent authorities on operators authorised to apply the mark referred to in Article 96(1) of Regulation (EU) 2016/2031 or to issue the official attestation referred to in point (a) of Article 99(2) of that Regulation.

specific requirements for the performance of official controls to respond to recognised uniform hazards and risks of:

the cases where the competent authorities in relation to specific non-compliances are to take one or more of the measures referred to in Articles 137(2) and 138(2).

the presence in the agri-food chain of GMOs for food and feed production and of genetically modified food and feed which have not been authorised in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003;

the cultivation of GMOs for food and feed production and the correct application of the plan for monitoring referred to in point (e) of Article 13(2) of Directive 2001/18/EC and in point (b) of Article 5(5) and point (b) of Article 17(5) of Regulation (EC) No 1829/2003.

results of relevant monitoring activities including those on pesticides residues carried out for the purpose of Article 32(2) of Regulation (EC) No 396/2005 and of Article 8 of Directive 2000/60/EC of the European Parliament and of the Council (55);

information on non-authorised plant protection products, including illegal trade of plant protection product, and results of relevant controls by the authorities referred to in Article 8 of Regulation (EU) No 649/2012 of the European Parliament and of the Council (56); and

information on poisoning related to plant protection products, including information available in accordance to Article 56 of Regulation (EC) No 1107/2009, and information on emergency health responses made available by the centres referred to in Article 45(1) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council (57).

specific requirements for the performance of such official controls to respond to recognised uniform hazards and risks which might be posed by plant protection products, concerning the manufacture, placing on the market, entry into the Union, labelling, packaging, transport, storage and use of plant protection products to ensure their safe and sustainable use and to combat their illegal trade; and

the cases where the competent authorities in relation to specific non-compliances are to take one or more of the measures referred to in Articles 137(2) and 138(2).

uniform minimum frequency of such official controls, where a minimum level of official control is necessary to respond to recognised uniform hazards and risks which might be posed by plant protection products, concerning the manufacture, placing on the market, entry into the Union, labelling, packaging, transport, storage and use of plant protection products to ensure their safe and sustainable use and to combat their illegal trade;

the collection of information, monitoring and reporting on suspected poisonings from plant protection products;

the collection of information, and the monitoring of and reporting on non-authorised plant protection products including illegal trade of plant protection products.

specific requirements and additional content to that provided for in Article 110 to prepare the relevant parts of the MANCP provided for in Article 109(1), and specific additional content to the report provided for in Article 113;

specific responsibilities and tasks for the European Union reference centres in addition to those provided for in Article 98;

practical arrangements for activating the mechanisms of administrative assistance provided for in Articles 102 to 108, including the exchange of information concerning instances of non-compliance or the likelihood of non-compliance between competent authorities and delegated bodies;

the methods to be used for sampling and for laboratory analyses and tests, excluding any rules involving the setting of thresholds.

ordering that certain activities of the operator be subject to systematic or increased official controls;

ordering the operator to increase the frequency of own controls;

ordering the alteration of label in order to comply with the product specifications and the rules referred in point (j) of Article 1(2).

requirements, methods and techniques referred to in Articles 12 and 14 for official controls performed to verify compliance with product specifications and labelling requirements;

specific methods and techniques referred to in Article 14 for the performance of official controls aimed at ensuring the traceability of goods and animals falling within the scope of the rules referred to in point (j) of Article 1(2) at all stages of production, preparation and distribution, and at providing assurances as to compliance with those rules;

the cases where the competent authorities, in relation to specific non-compliances, are to take one or more of the actions and measures referred to in Article 138(1) and (2).

specific practical arrangements for activating the mechanisms of administrative assistance provided for in Articles 102 to 108, including the exchange of information concerning instances of non-compliance or the likelihood of non-compliance between competent authorities and delegated bodies; and

specific reporting obligations of the delegated bodies.

uniform specific requirements for the performance of official controls to respond to the specific hazards and risks which exist in relation to each category of food and feed and the different processes it undergoes; and

the cases where the competent authorities, in relation to specific non-compliances, are to take one or more of the measures referred to in Articles 137(2) and 138(2).

the delegation contains a precise description of those official control tasks that the delegated body may perform, and the conditions under which it may perform those tasks;

the delegated body:

there are arrangements in place ensuring efficient and effective coordination between the delegating competent authorities and the delegated body.

the delegation contains a precise description of those official control tasks that the natural persons may perform and the conditions under which the natural persons may perform those tasks;

the natural persons:

there are arrangements in place ensuring efficient and effective coordination between the delegating competent authorities and the natural persons.

the rules referred to in Article 1(2) do not prohibit such delegation; and

the conditions laid down in Article 29 are fulfilled with the exception of that laid down in point (b)(iv).

the rules referred to in Article 1(2) allow such delegation; and

the conditions laid down in Article 30, applied mutatis mutandis, are fulfilled.

communicate the outcome of the official controls and other official activities performed by them to the delegating competent authorities on a regular basis and whenever those competent authorities so request;

immediately inform the delegating competent authorities whenever the outcome of the official controls indicate non-compliance or point to the likelihood of non-compliance, unless specific arrangements established between the competent authority and the delegated body or the natural person concerned provides otherwise; and

give competent authorities access to their premises and facilities and cooperate and provide assistance.

organise audits or inspections of such bodies or persons, as necessary and avoiding duplication, taking into account any accreditation referred to in point (b)(iv) of Article 29;

fully or partly withdraw the delegation without delay where:

This point shall be without prejudice to the competence of the competent authorities to withdraw the delegation for reasons other than those referred to in this Regulation.

available methods complying with relevant internationally recognised rules or protocols including those that the European Committee for Standardisation (CEN) has accepted; or

relevant methods developed or recommended by the European Union reference laboratories and validated in accordance with internationally accepted scientific protocols;

in the absence of the suitable rules or protocols, as referred to in point (a), methods which comply with relevant rules established at national level, or, if no such rules exist, relevant methods developed or recommended by national reference laboratories and validated in accordance with internationally accepted scientific protocols; or

relevant methods developed and validated with inter or intra-laboratory methods validation studies in accordance with internationally accepted scientific protocols.

the methods to be used for sampling and for laboratory analyses, tests and diagnoses;

performance criteria, analysis, test or diagnosis parameters, measurement uncertainty and procedures for the validation of those methods;

the interpretation of analytical, testing and diagnostic results.

when taking the sample, and if so requested by the operator, ensure that a sufficient quantity is taken to allow for a second expert opinion and for the review referred to in paragraph 3, should this prove necessary; or

where it is not possible to take a sufficient quantity as referred to in point (a), inform the operator thereof.

are informed that such samples have been taken in the context of an official control and, where appropriate, are analysed or tested for the purposes of such official control; and

where the samples referred to in that paragraph are analysed or tested, are able to exercise the right to a second expert opinion, as provided for in Article 35(1).

appropriate arrangements are in place under which the competent authorities are enabled to perform the audits and inspections referred to in Article 39(1) or delegate the performance of such audits and inspections to the competent authorities of the Member State or third country that is a Contracting Party to the Agreement on the European Economic Area where the laboratory is located; and

that laboratory is already designated as an official laboratory by the competent authorities of the Member State on whose territory it is located.

the tasks that the laboratory carries out as an official laboratory;

the conditions under which it carries out the tasks referred to in point (a); and

the arrangements necessary to ensure efficient and effective coordination and collaboration between the laboratory and the competent authorities.

has the expertise, equipment and infrastructure required to carry out analyses or tests or diagnoses on samples;

has a sufficient number of suitably qualified, trained and experienced staff;

ensures that the tasks conferred upon it as set out in paragraph 1 are performed impartially and which is free from any conflict of interest as regards the exercise of its tasks as an official laboratory;

can deliver in a timely manner the results of the analysis, test or diagnosis carried out on the samples taken during official controls and other official activities; and

operates in accordance with the standard EN ISO/IEC 17025 and is accredited in accordance with that standard by a national accreditation body operating in accordance with Regulation (EC) No 765/2008.

shall include those methods of laboratory analysis, test or diagnosis required to be used by the laboratory for analyses, tests or diagnoses, when it operates as an official laboratory;

may comprise one or more methods of laboratory analysis, test or diagnosis or groups of methods;

may be defined in a flexible manner, so as to allow the scope of accreditation to include modified versions of the methods used by the official laboratory when the accreditation was granted or new methods in addition to those methods, on the basis of the laboratory’s own validations without a specific assessment by the national accreditation body prior to the use of those modified or new methods.

it no longer complies with the conditions provided for in Article 37(4) and (5);

it does not comply with the obligations provided for in Article 38;

it is underperforming at inter-laboratory comparative tests referred to in Article 38(2).

laboratories:

laboratories which only carry out analyses, tests or diagnoses in the context of other official activities, provided that they:

they operate and are accredited in accordance with the standard EN ISO/IEC 17025 for the use of one or more methods which are similar to and representative of the other methods they use; and

they make regular and significant use of the methods for which they have obtained the accreditation referred to in point (a) of this Article; except, as regards the area governed by the rules referred to in point (g) of Article 1(2), where a validated method for the detection of the particular pests of plants referred to in Article 34(1) and (2) does not exist.

when the use of that method is newly required by Union rules;

when changes to a method in use require a new accreditation or an extension of the scope of the accreditation obtained by the official laboratory; or

in cases where the need for the use of the method results from an emergency situation or an emerging risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment.

the official laboratory is already accredited in accordance with the standard EN ISO/IEC 17025 for the use of a method which is similar to the one not included within the scope of its accreditation;

a quality assurance system is in place in the official laboratory to ensure sound and reliable results by using a method which is not included within the scope of the existing accreditation;

the analyses, tests or diagnoses are carried out under the supervision of the competent authorities or the national reference laboratory for that method.

the risks to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, associated with different types of animals and goods;

any information indicating the likelihood that consumers might be misled, in particular as to the nature, identity, properties, composition, quantity, durability, country of origin or place of provenance, method of manufacture or production of goods;

the history of compliance with the requirements established by the rules referred to in Article 1(2) applicable to the animals or goods concerned:

the controls that have already been performed on the animals and goods concerned; and

the guarantees that the competent authorities of the third country of origin have given with regard to compliance of the animals and goods with the requirements established by the rules referred to in Article 1(2) or with requirements recognised to be at least equivalent thereto.

the point of entry into the Union;

a border control post;

the point of release for free circulation in the Union;

the warehouses and the premises of the operator responsible for the consignment;

the place of destination.

means of transport, including where empty; and

packaging, including pallets.

always include a documentary check; and

include identity checks and physical checks depending on the risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment.

inform the operators concerned and, where appropriate, the customs authorities; and

decide whether the animals or goods need to be detained pending the results of the analysis, test or diagnosis carried out, or whether they can be released provided that the traceability of the animals or goods is ensured.

establish the procedures necessary to ensure the traceability of the animals or goods referred to in point (b) of paragraph 1; and

identify the documents that must accompany the animals or goods referred to in paragraph 1 when samples have been taken by the competent authorities.

animals;

products of animal origin, germinal products and animal by-products;

plants, plant products, and other objects as referred to in the lists established pursuant to Articles 72(1) and 74(1) of Regulation (EU) 2016/2031;

goods from certain third countries for which the Commission has decided, by means of implementing acts provided for in point (b) of paragraph 2 of this Article, that a measure requiring a temporary increase of official controls at their entry into the Union is necessary due to a known or emerging risk or because there is evidence that widespread serious non-compliance with the rules referred to in Article 1(2) might be taking place;

animals and goods which are subject to an emergency measure provided for in acts adopted in accordance with Article 53 of Regulation (EC) No 178/2002, Article 249 of Regulation (EU) 2016/429, or Articles 28(1), 30(1), 40(3), 41(3), 49(1), 53(3) and 54(3) of Regulation (EU) 2016/2031 requiring consignments of those animals or goods, identified by means of their codes from the Combined Nomenclature, to be subject to official controls at their entry into the Union;

animals and goods in relation to whose entry into the Union conditions or measures have been established by acts adopted in accordance with Article 126 or 128 respectively, or with the rules referred to in Article 1(2), which require that compliance with those conditions or measures be ascertained at the entry of the animals or goods into the Union.

establish lists which set out all the animals and goods referred to in points (a) and (b) of paragraph 1, indicating their codes from the Combined Nomenclature; and

establish the list of goods belonging to the category referred to in point (d) of paragraph 1, indicating their codes from the Combined Nomenclature, and update it as necessary in relation to the risks referred to in that point.

goods sent as trade samples or as display items for exhibitions, which are not intended to be placed on the market;

animals and goods intended for scientific purposes;

goods on board means of transport operating internationally which are not unloaded and are intended for consumption by the crew and passengers;

goods which form part of passengers personal luggage and are intended for personal consumption or use;

small consignments of goods sent to natural persons which are not intended to be placed on the market;

pet animals as defined in point (11) of Article 4 of Regulation (EU) 2016/429;

goods which have undergone specific treatment and do not exceed quantities to be established in those delegated acts;

categories of animals or goods posing a low risk or no specific risk and for which controls at border control posts are therefore not necessary.

animals, except aquatic animals, or meat and edible meat offal, by an official veterinarian, who may be assisted by staff trained in accordance with the requirements established under paragraph 5 in veterinary matters and designated by the competent authorities for that purpose;

aquatic animals, products of animal origin other than the ones referred to in point (a) of this paragraph, germinal products or animal by-products, by an official veterinarian or by staff trained in accordance with the requirements established under paragraph 5 and designated by the competent authorities for that purpose;

plants, plant products and other objects, by an official plant health officer.

the cases where, and the conditions under which, the competent authorities of a border control post may authorise the onward transportation of consignments of the categories of animals and goods referred to in Article 47(1) to the place of final destination pending the availability of the results of physical checks, where such checks are required;

the time limits and arrangements for carrying out documentary checks and, where necessary, identity checks and physical checks on categories of animals and goods subject to the official controls provided for in Article 47(1) which enter the Union by sea or by air transport from a third country, when those animals or goods are moved from a vessel or aircraft and are transported under customs supervision to another vessel or aircraft in the same port or airport in preparation for onward travel (‘transhipped consignments’);

the cases where, and the conditions under which, identity checks and physical checks of transhipped consignments and of animals arriving by air or sea and staying on the same means of transport for onward travel may be performed at a border control post other than the one of first arrival into the Union;

the cases where, and the conditions under which, the transit of consignments of the categories of animals and goods referred to in Article 47(1) may be authorised and certain official controls to be performed at border control posts on such consignments, including the cases and conditions for the storage of goods in specially approved customs warehouses or in free zones;

the cases where, and the conditions under which, derogations from the rules on identity checks and physical checks shall apply as regards transhipped consignments and transit of consignments of the goods referred to in point (c) of Article 47(1).

identity checks and physical checks on consignments of the categories of animals and goods referred to in Article 47(1) may be performed by competent authorities at control points other than border control posts provided that those control points comply with the requirements provided for in Article 64(3) and in the implementing acts adopted in accordance with Article 64(4);

physical checks on consignments which have undergone documentary checks and identity checks at a border control post of first arrival into the Union may be performed at another border control post in a different Member State;

identity checks and physical checks on consignments which have undergone documentary checks at a border control post of first arrival into the Union may be performed at another border control post in a different Member State;

specific control tasks may be performed by customs authorities or other public authorities, insofar as those tasks are not already falling under the responsibility of those authorities, on:

documentary checks on consignments of plant, plant products and other objects referred to in point (c) of Article 47(1) may be performed at distance from a border control post.

the criteria and the procedures for determining and modifying the frequency rates of identity checks and physical checks to be performed on consignments of the categories of animals and goods referred to in points (a), (b) and (c) of Article 47(1) and to adjust them to the level of risk associated with those categories, having regard to:

the conditions under which Member States may increase the frequency rates of identity checks and physical checks established in accordance with point (a) so as to take account of local risk factors;

the procedures for ensuring that the frequency rates of identity checks and physical checks established in accordance with point (a) are applied in a timely and uniform manner.

the frequency of identity checks and physical checks for the categories of goods referred to in point (d) of Article 47(1); and

the frequency of identity checks and physical checks for the categories of animals and goods referred to in points (e) and (f) of Article 47(1) as long as this is not already provided for in the acts referred to therein.

an official veterinarian where they concern animals, products of animal origin, germinal products or animal by-products; or

an official plant health officer where they concern plants, plant products and other objects.

the operators responsible for consignments of the categories of animals and goods referred to in Article 47(1) in order to give prior notification to the competent authorities of the border control post of arrival of those consignments; and

the competent authorities of the border control post, in order to:

all official controls required by Article 49(1) have been performed;

the results from physical checks, where such checks are required, are available; and

a decision on the consignment has been taken in accordance with Article 55 and recorded on the CHED.

not allow the placing of the consignment under a customs procedure different from the one indicated by the competent authorities of the border control post; and

without prejudice to the exemptions referred to in Article 48 and the rules referred to in Articles 53 and 54, only allow the release for free circulation of a consignment upon presentation of a duly finalised CHED which confirms that the consignment is in compliance with the applicable rules referred to in Article 1(2).

the format of the CHED and the instructions for its presentation and use, taking into account relevant international standards; and

the minimum time requirements for prior notification of consignments by operators responsible for the consignment as provided for in point (a) of Article 56(3) in order to enable the competent authorities of the border control post to perform official controls in a timely and effective manner.

whether the designation of the proposed border control post is dependent upon the favourable outcome of a control performed by Commission experts in accordance with Article 116 in order to verify compliance with the minimum requirements laid down in Article 64; and

of the date of such a control, which is not to be later than six months from the notification.

its contact details;

its opening hours;

its exact location and whether it is a port, airport, rail or road entry point; and

the categories of animals and goods referred to in Article 47(1) which are included in the scope of its designation.

withdraw the designation provided for in Article 59(1) for all or for certain categories of animals and goods for which the designation was made; and

remove those border control posts from the lists referred to in Article 60(1), for the categories of animals and goods for which the designation is withdrawn.

the competent authorities are satisfied that the risk referred to in paragraph 1 no longer exists; and

they have communicated to the Commission and to the other Member States the information on the basis of which the suspension is removed.

a sufficient number of suitably qualified staff;

premises or other facilities appropriate to the nature and volume of the categories of animals and goods handled;

equipment and premises or other facilities to allow the performance of official controls for each of the categories of animals and goods for which the border control post has been designated;

arrangements in place to ensure, as appropriate, access to any other equipment, premise and service necessary to apply the measures taken in accordance with Articles 65, 66 and 67 in cases of suspicion of non-compliance, non-compliant consignments or consignments presenting a risk;

contingency arrangements to ensure the smooth operation of official controls and the effective application of the measures taken in accordance with Articles 65, 66 and 67 in cases of unforeseeable and unexpected conditions or events;

the technology and equipment necessary for the efficient operation of the IMSOC and, as appropriate, of other computerised information management systems necessary for the handling and exchange of data and information;

access to the services of official laboratories capable of providing analytical, testing and diagnostic results within appropriate deadlines and equipped with the information technology tools necessary to ensure the introduction of the results of analyses, tests or diagnoses carried out into the IMSOC as appropriate;

appropriate arrangements for the proper handling of different categories of animals and goods and to prevent risks which may result from cross-contamination; and

arrangements to comply with relevant biosecurity standards in order to prevent the spread of diseases into the Union.

destroy the consignment;

re-dispatch the consignment outside the Union in accordance with Article 72(1) and (2); or

subject the consignment to special treatment in accordance with Article 71(1) and (2) or to any other measure necessary to ensure compliance with the rules referred to in Article 1(2), and, where appropriate, allocate the consignment for purposes other than those for which it was originally intended.

is such as to ensure compliance;

does not pose a risk to human, animal or plant health or to animal welfare or, as regards GMOs and plant protection products, also to the environment; and

does not disrupt official control operations.

the Commission;

the competent authorities of the other Member States;

the customs authorities;

the competent authorities of the third country of origin; and

the operator responsible for the consignment.

destroy the consignment in compliance with the rules referred to in Article 1(2), taking all the measures necessary to protect human, animal or plant health, animal welfare or the environment, and as regards live animals including in particular the rules on the sparing of any avoidable pain, distress or suffering; or

subject the consignment to special treatment in accordance with Article 71(1) and (2).

invalidate the official certificates and as appropriate other relevant documents accompanying consignments which have been subject to measures pursuant to Article 66(3) and (6) and Article 67; and

cooperate in accordance with Articles 102 to 108 to take any further measures necessary to ensure that it is not possible to reintroduce consignments into the Union which have been refused entry in accordance with Article 66(1).

that the consignment be destroyed or subject to any other appropriate measure;

in the cases referred to in Article 67, that the consignment be destroyed in suitable facilities located as close as possible to the border control post, taking all measures necessary to protect human, animal or plant health, animal welfare or the environment.

treatment or processing, including decontamination, where appropriate, but excluding dilution, so that the consignment complies with the requirements of the rules referred to in Article 1(2), or with the requirements of a third country of re-dispatch; or

treatment in any other manner suitable for safe animal or human consumption or for purposes other than animal or human consumption.

be carried out effectively and ensure the elimination of any risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment;

be documented and carried out under the control of the competent authorities or, where appropriate, under the control of the competent authorities of another Member State by mutual agreement; and

comply with the requirements laid down in the rules referred to in Article 1(2).

the destination has been agreed with the operator responsible for the consignment;

the operator responsible for the consignment has informed the competent authorities of the Member State in writing that the competent authorities of the third country of origin or, if different, the third country of destination have been informed of the reasons and circumstances for the refusal of the entry into the Union of the consignment of animals or goods concerned;

where the third country of destination is not the third country of origin, the operator has obtained the agreement of the competent authorities of that third country of destination and those competent authorities have notified the competent authorities of the Member State that they are prepared to accept the consignment; and

in the case of consignments of animals, the re-dispatch is in compliance with animal welfare requirements.

the maximum frequency of official controls to be performed by the competent authorities of Member States at the entry of the consignments into the Union, where there is no reason to suspect non-compliance with the rules referred to in Article 1(2) or fraudulent or deceptive practices;

the official certificates that must accompany consignments entering the Union;

a model for the certificates referred to in point (b);

the competent authorities of the third country under the responsibility of which pre-export controls must be performed; and

where appropriate, any delegated body to which those competent authorities may delegate certain tasks. Such delegation may only be approved if it meets the criteria set out in Articles 28 to 33 or equivalent conditions.

the consignments of the animals or goods exported to the Union meet the requirements of the rules referred to in Article 1(2), or equivalent requirements; and

the controls performed in the third country prior to dispatch to the Union are sufficiently effective to replace or reduce the frequency of the documentary, identity checks and physical checks laid down in the rules referred to in Article 1(2).

be responsible for contacts with the Union; and

ensure that the official certificates referred to in point (b) of paragraph 2 accompany each consignment that is controlled.

notify the Commission and the other Member States and operators concerned via the IMSOC in addition to seeking administrative assistance in accordance with the procedures established in Articles 102 to 108; and

increase the number of official controls on consignments from the relevant third country and, where necessary to allow a proper analytical examination of the situation, keep an appropriate number of samples under appropriate storage conditions.

ensure reciprocal access to information which is necessary for the organisation and conduct of their respective activities in relation to animals and goods entering the Union; and

ensure the timely exchange of such information, including via electronic means.

access by competent authorities to the information necessary for the immediate and complete identification of the consignments of animals and goods entering the Union that are subject to official controls at a border control post in accordance with Article 47(1);

the reciprocal update, through exchanges of information or synchronisation of relevant data sets, of information gathered by competent authorities, customs authorities and other authorities on consignments of animals and goods entering the Union; and

the swift communication of decisions taken by such authorities on the basis of the information referred to in points (a) and (b).

they shall request the customs authorities not to release the consignment for free circulation and to include the following statement on the commercial invoice accompanying the consignment and on any other relevant accompanying document or the relevant electronic equivalents:

‘Product presents a risk — release for free circulation not authorised — Regulation (EU) 2017/…’;

no other customs procedure shall be permitted without the consent of the competent authorities; and

Article 66(1), (3), (5) and (6), Articles 67, 68 and 69, Article 71(1) and (2) and Article 72(1) and (2) shall apply.

consignments of fresh fishery products directly landed in ports designated by Member States in accordance with Article 5(1) of Council Regulation (EC) No 1005/2008 (61) from a fishing vessel flying a third country flag;

consignments of unskinned, furred wild game;

consignments of the categories of goods referred to in point (b) of Article 47(1) which are delivered, with or without storage in a specially approved customs warehouses or in free zones, to vessels leaving the Union and intended for ship supply or consumption by the crew and passengers;

wood packaging material;

feed accompanying animals and intended for the feeding of those animals;

animals and goods ordered by sales through distance contracts and delivered from a third country to an address in the Union, and the notification requirements necessary to allow the proper performance of official controls;

plant products which, on account of their subsequent destination, may give rise to the risk of spreading infectious or contagious animal diseases;

consignments of the categories of animals and goods referred to in points (a), (b) and (c) of Article 47(1) originating from, and returning to, the Union following a refusal of entry by a third country;

goods entering the Union in bulk from a third country, irrespective of whether they all originate from that third country;

consignments of goods referred to in Article 47(1) coming from the territory of Croatia and transiting through the territory of Bosnia and Herzegovina at Neum (‘Neum corridor’) before re-entering the territory of Croatia via the points of entry at Klek or Zaton Doli;

animals and goods exempted from Article 47 in accordance with Article 48.

model official certificates and rules for the issuance of such certificates; and

the format of documents that must accompany the categories of animals or goods referred to in paragraph 1.

at the level of the cost calculated in accordance with Article 82(1); or

at the amounts provided for in Annex IV.

official controls performed on animals and goods referred to in points (d), (e) and (f) of Article 47(1);

official controls performed at the request of the operator, to obtain the approval provided for in Article 10 of Regulation (EC) No 183/2005;

official controls which were not originally planned, and which;

the interests of operators with a low throughput;

the traditional methods used for production, processing and distribution;

the needs of operators located in regions subject to specific geographical constraints; and

the operators’ record of compliance with the relevant rules referred to in Article 1(2) as ascertained through official controls.

the salaries of the staff, including support and administrative staff, involved in the performance of official controls, their social security, pension and insurance costs;

the cost of facilities and equipment, including maintenance and insurance costs and other associated costs;

the cost of consumables and tools;

the cost of services charged to the competent authorities by delegated bodies for official controls delegated to these delegated bodies;

the cost of training of the staff referred to in point (a), with the exclusion of the training necessary to obtain the qualification necessary to be employed by the competent authorities;

the cost of travel of the staff referred to in point (a), and associated subsistence costs;

the cost of sampling and of laboratory analysis, testing and diagnosis charged by official laboratories for those tasks.

at a flat-rate on the basis of the overall costs of official controls borne by the competent authorities over a given period of time, and applied to all operators irrespective of whether any official control is performed during the reference period in relation to each operator charged; in establishing the level of the fees to be charged for each sector, activity and category of operators, the competent authorities shall take into consideration the impact that the type and the size of the activity concerned, and the relevant risk factors, have on the distribution of the overall costs of those official controls; or

on the basis of the calculation of the actual costs of each individual official control, and applied to the operators subject to such official control.

the fees or charges provided for in point (a) of Article 79(1), Article 79(2) and Article 80, namely on:

the identity of the authorities or bodies responsible for the collection of the fees or charges.

official certificates; or

official attestations in the cases provided for in the rules referred to in Article 1(2).

when the rules referred to in Article 1(2) require the issuance of an official certificate; and

to official certificates which are necessary for the purposes of exporting consignments of animals and goods to third countries or which are requested from the competent authority of a Member State of dispatch by the competent authority of a Member State of destination in respect of consignments of animals and goods which are to be exported to third countries.

are impartial, free from any conflict of interest, and in particular are not in a situation which may, directly or indirectly, affect the impartiality of their professional conduct in relation to what is being certified; and

have received appropriate training on the rules with which compliance is certified by an official certificate and on the technical assessment of compliance with those rules as well as with the relevant rules laid down in this Regulation.

direct knowledge by the certifying officer of up-to-date facts and data relevant for the certification that is obtained through:

facts and data relevant for the certification, knowledge of which was ascertained by another person authorised for that purpose by, and acting under the control of, the competent authorities, provided that the certifying officer can verify the accuracy of such facts and data;

facts and data relevant for the certification which were obtained from the operators’ own control systems, complemented and confirmed by results from regular official controls, where the certifying officer is thus satisfied that the conditions for issuing the official certificate are met.

bear a unique code;

not be signed by the certifying officer where they are blank or incomplete;

be drawn up in one or more of the official languages of the institutions of the Union understood by the certifying officer and, where relevant, in one of the official languages of the Member State of destination;

be authentic and accurate;

allow for the identification of the person who signed them and the date of issue; and

allow the easy verification of the links between the certificate, the issuing authority and the consignment, lot or individual animal or good covered by the certificate.

model official certificates and rules for the issuance of such certificates, where requirements are not laid down in the rules referred to in Article 1(2);

the mechanisms and technical arrangements to ensure the issuance of accurate and reliable official certificates, and prevent risk of fraud;

the procedures to be followed in the case of withdrawals of official certificates and for the issuance of replacement certificates;

rules for the production of certified copies of official certificates;

the format of documents that must accompany animals and goods after official controls have been performed;

rules for the issuance of electronic certificates and for the use of electronic signatures.

be authentic and accurate;

be drawn up in one or more of the official languages of the institutions of the Union and, where relevant, in one of the official languages of the Member State of destination; and

where they relate to a consignment or a lot, allow the verification of the link between the official attestation and that consignment or lot.

are impartial, free from any conflict of interest, and in particular are not in a situation which may, directly or indirectly, affect the impartiality of their professional conduct in relation to what is being certified by the official attestations; and

have received appropriate training on:

the operators issuing the attestations comply with the conditions laid down in the rules referred to in Article 1(2); and

the attestation is issued on the basis of relevant, correct and verifiable facts and data.

the methods of analysis, test or diagnosis employed by the official laboratories designated in accordance with Article 37(1); and

the results of the analyses, tests and diagnoses performed by those official laboratories.

follow a public selection process; and

be limited in time and with a minimum period of five years, or reviewed regularly.

operate in accordance with standard EN ISO/IEC 17025 and be accredited in accordance with that standard by a national accreditation body, operating in accordance with Regulation (EC) No 765/2008. The scope of that accreditation:

be impartial, free from any conflict of interest, and in particular not be in a situation which may, directly or indirectly, affect the impartiality of their professional conduct as regards the exercise of their tasks as European Union reference laboratories;

have, or have contractual access to, suitably qualified staff with adequate training in analytical, testing and diagnostic techniques applied in their area of competence, and support staff as appropriate;

possess, or have access to, the infrastructure, equipment and products necessary to carry out the tasks assigned to them;

ensure that their staff and any contractually engaged staff have good knowledge of international standards and practices and that the latest developments in research at national, Union and international level are taken into account in their work;

be equipped, or have access to, the necessary equipment to perform their tasks in emergency situations; and

where relevant, be equipped to comply with relevant biosecurity standards.

GMOs and genetically modified food and feed; and

feed additives.

providing national reference laboratories with details and guidance on the methods of laboratory analysis, testing or diagnosis, including reference methods;

providing reference materials to national reference laboratories;

coordinating the application by the national reference laboratories and, if necessary, by other official laboratories of the methods referred to in point (a), in particular, by organising regular inter-laboratory comparative testing or proficiency tests and by ensuring appropriate follow-up of such comparative testing or proficiency tests in accordance, where available, with internationally accepted protocols, and informing the Commission and the Member States of the results and follow-up to the inter-laboratory comparative testing or proficiency tests;

coordinating practical arrangements necessary to apply new methods of laboratory analysis, testing or diagnosis, and informing national reference laboratories of advances in this field;

conducting training courses for staff from national reference laboratories and, if needed, from other official laboratories, as well as of experts from third countries;

providing scientific and technical assistance to the Commission within the scope of their mission;

providing information on relevant national, Union and international research activities to national reference laboratories;

collaborating within the scope of their mission with laboratories in third countries and with the European Food Safety Authority (EFSA), the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC);

assisting actively in the diagnosis of outbreaks in Member States of foodborne, zoonotic or animal diseases, or of pests of plants, by carrying out confirmatory diagnosis, characterisation and taxonomic or epizootic studies on pathogen isolates or pest specimens;

coordinating or performing tests for the verification of the quality of reagents and lots of reagents used for the diagnosis of foodborne, zoonotic or animal diseases and pests of plants;

where relevant for their area of competence, establishing and maintaining:

where relevant for their area of competence, cooperate among themselves and with the Commission, as appropriate, to develop methods of analysis, testing or diagnosis of high standards.

follow a public selection process; and

be limited in time or reviewed regularly.

act impartially as regards the exercise of their tasks as European Union reference centres;

possess a high level of scientific and technical expertise in human-animal relationship, animal behaviour, animal physiology, animal genetics, animal health and nutrition related to animal welfare, and animal welfare aspects related to the commercial and scientific use of animals;

have suitably qualified staff with adequate training in the areas referred to in point (b) and in ethical issues related to animals and support staff as appropriate;

possess, or have access to, the infrastructure, the equipment and products necessary to carry out the tasks assigned to them; and

ensure that their staff have good knowledge of international standards and practices in the areas referred to in point (b) and that the latest developments in research at national, Union and international level, including studies performed and actions undertaken by other European Union reference centres for animal welfare, in those areas are taken into account in their work.

providing scientific and technical expertise within the scope of their mission including, where appropriate in the form of coordinated assistance, to relevant national support networks and bodies in the area governed by the rules referred to in point (f) of Article 1(2);

providing scientific and technical expertise for the development and application of the animal welfare indicators referred to in point (e) of Article 21(8);

developing or coordinating the development of methods for the assessment of the level of welfare of animals and of methods for the improvement of the welfare of animals;

carrying out scientific and technical studies on the welfare of animals used for commercial or scientific purposes;

conducting training courses for staff of the national scientific support networks or bodies referred to in point (a), for staff of the competent authorities and for experts from third countries; and

disseminating research findings and technical innovations and collaborating with Union research bodies in the fields within the scope of their mission.

follow a public selection process; and

be limited in time or reviewed regularly.

act impartially as regards the exercise of their tasks as European Union reference centres;

possess a high level of scientific and technical expertise in the areas governed by the rules referred to in Article 1(2) and in applied forensic science in those areas, in order to have the ability to carry out or coordinate research at the highest level on the authenticity and integrity of goods and to develop, apply and validate the methods to be used for the detection of violations of the rules referred to in Article 1(2) perpetrated through fraudulent or deceptive practices;

have suitably qualified staff with adequate training in the areas referred to in point (b) and the necessary support staff;

possess, or have access to, the infrastructure, the equipment and the products necessary to carry out the tasks assigned to them; and

ensure that their staff have good knowledge of international standards and practices in the areas referred to in point (b) and that the latest research developments at national, Union and international level in those areas are taken into account in their work.

providing specialised knowledge in relation to the authenticity and integrity of the agri-food chain and to the methods for detecting violations of the rules referred to in Article 1(2) of this Regulation perpetrated through fraudulent or deceptive practices, in relation to the forensic science applied to the areas governed by these rules;

providing specific analyses designed to identify the segments of the agri-food chain that are potentially subject to violations of the rules referred to in Article 1(2) of this Regulation perpetrated through fraudulent or deceptive practices and helping to develop specific official control techniques and protocols;

where necessary, performing the tasks referred to in points (a) to (h) of Article 94(2) of this Regulation, thereby avoiding duplication with the tasks of European Union reference laboratories designated in accordance with Article 93 of this Regulation;

where necessary, establishing and maintaining collections or databases of authenticated reference materials, to be used to detect violations of the rules referred to in Article 1(2) of this Regulation perpetrated through fraudulent or deceptive practices; and

disseminating research findings and technical innovations in the fields within the scope of their mission.

European Union reference laboratories provided for in Article 93;

European Union reference centres for animal welfare provided for in Article 95;

European Union reference centres for the authenticity and integrity of the agri-food chain provided for in Article 97.

by means of an implementing act, withdraw the designation of that laboratory or centre; or

take any other appropriate measure.

be impartial, free from any conflict of interests, and in particular not be in a situation which may, directly or indirectly, affect the impartiality of their professional conduct as regards the exercise of their tasks as national reference laboratories;

have, or have contractual access to, suitably qualified staff with adequate training in analytical, testing and diagnostic techniques in their area of competence, and support staff as appropriate;

possess, or have access to, the infrastructure, equipment and products needed to carry out the tasks assigned to them;

ensure that their staff and any contractually engaged staff have good knowledge of international standards and practices and that the latest developments in research at national, Union and international level are taken into account in their work;

be equipped with, or have access to, the necessary equipment to perform their tasks in emergency situations; and

where relevant, be equipped to comply with relevant biosecurity standards.

communicate the name and address of each national reference laboratory to the Commission, the relevant European Union reference laboratory and other Member States;

make the information referred to in point (a) available to the public; and

update the information referred to in point (a) whenever necessary.

collaborate with the European Union reference laboratories, and participate in training courses and in inter-laboratory comparative tests organised by these laboratories;

coordinate the activities of official laboratories designated in accordance with Article 37(1) with a view of harmonising and improving the methods of laboratory analysis, test or diagnosis and their use;

where appropriate, organise inter-laboratory comparative testing or proficiency tests between official laboratories, ensure an appropriate follow-up of such tests and inform the competent authorities of the results of such tests and follow-up;

ensure the dissemination to the competent authorities and official laboratories of information that the European Union reference laboratory supplies;

provide within the scope of their mission scientific and technical assistance to the competent authorities for the implementation of MANCPs referred to in Article 109 and of coordinated control programmes adopted in accordance with Article 112;

where relevant, validate the reagents and lots of reagents, establish and maintain up-to-date lists of available reference substances and reagents and of manufacturers and suppliers of such substances and reagents;

where necessary, conduct training courses for the staff of official laboratories designated under Article 37(1); and

assist actively the Member State having designated them in the diagnosis of outbreaks of foodborne, zoonotic or animal diseases or of pests of plants and in case of non-compliance of consignments, by carrying out confirmatory diagnoses, characterisation and epizootic or taxonomic studies on pathogen isolates or pest specimens.

applicable to the release of documents and information that are the object of, or related to, judicial investigations and court proceedings, including criminal investigations; and

aimed at the protection of natural or legal persons’ commercial interests.

a risk to human, animal or plant health, or to animal welfare, or, as regards GMOs and plant protection products, also to the environment; or

a possible violation of the rules referred to in Article 1(2) perpetrated through fraudulent or deceptive practices.

the requests for assistance provided for in Article 104(1); and

the communication of common and recurrent notifications and responses.

acknowledge receipt of the request without delay;

where the requesting competent authority so specifies, indicate within ten working days from the date of receipt of the request, the estimated time necessary to provide an informed response to the request; and

perform official controls or investigations necessary to provide the requesting competent authorities without delay with all necessary information and documents to enable them to take informed decisions and verify compliance with Union rules within their jurisdiction.

at all times be able to produce written authority stating their identity and their official capacity;

be granted access by the operator to the same premises and documents as the staff of the requested competent authorities, through their intermediary, and for the sole purpose of the administrative enquiry being carried out; and

not, on their own initiative, exercise the powers of enquiry conferred on officials of the requested competent authorities.

acknowledge receipt of the notification without undue delay;

where the notifying competent authority so specifies, indicate within ten working days from the date of receipt of the notification: