(1)

The Treaty on the Functioning of the European Union (‘Treaty’) requires a high level of human health protection to be ensured in the definition and implementation of all 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 direct objective the protection of human health.

(2)

The Treaty 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.

(3)

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 food chain or on the protection of consumers interests in relation to food and food information are carried out in accordance with specific requirements. Union rules exist also to ensure a high level of human, and animal and plant health and animal welfare along the 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) and plant protection products. Union rules also guarantee the identity and quality of plant reproductive material. The correct application of those rules, hereinafter collectively referred to as ‘Union agri-food chain legislation’, contributes to the functioning of the internal market. [Am. 2]

(4)

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 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.

(5)

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 in animals and animal products and to avoid the spread of infectious diseases of Union concern. It covers areas such as 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.

(6)

Article 13 of the Treaty recognises that animals are sentient beings. Union legislation on animal welfare requires animal owners, animal keepers and competent authorities to respect animal welfare requirements guaranteeing their humane treatment and avoiding their unnecessary pain and suffering. Such rules are based on scientific evidence and may indirectly improve the quality and safety of food and feed.

(7)

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 guaranteeing the quality and safety of food and feed made from plants.

(8)

Union legislation on plant reproductive material regulates the production with a view to placing on the market, and the placing on the market, of plant reproductive material of agricultural, vegetable, forest, fruit and ornamental species and vines. The objective of those rules is to ensure the identity, health and quality of plant reproductive material for its users, and the productivity, diversity, health and quality of the agri-food chain as well as contributing to the protection of biodiversity and the environment. [Am. 3]

(9)

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.

(10)

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.

(11)

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

(12)

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.

(13)

Regulation (EC) No 882/2004 of the European Parliament and of the Council (5) 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.

(14)

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 Union legislation on plant reproductive material and in Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002  (6) . 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 of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community  (7) . [Am. 4]

(15)

Council Directive 96/23/EC (8) also provides for a very detailed set of rules that establish, inter alia, minimum frequencies of official controls and specific enforcement measures to be adopted in cases of non-compliance.

(16)

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 should be more closely integrated, provided that they pursue the same objective with regard to control activities . For that purpose, Regulation (EC) No 882/2004 and other acts currently governing official controls in specific areas should be repealed and replaced by this Regulation. [Am. 5]

(17)

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 their application.

(18)

For the verification of compliance with the rules on the common organisation of the markets of agricultural products such as 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 the provisions of Council Regulation (EC) No 1234/2007 (9) , with the exception of Part II, Title II, Chapter I of that Regulation . [Am. 6]

(19)

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.

(20)

Union agri-food chain legislation entrusts the competent authorities of the Member States with specialised tasks to be carried out , not least 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, and in order to ensure the identity and a high quality of plant reproductive material. 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 risks which may arise for human, animal or plant health, animal welfare, or for the environment. Those activities, which include product approval, surveying, surveillance and monitoring, including for epidemiologic purposes, and the eradication and containment of diseases, and other disease control tasks, are governed by the same sectoral rules which are enforced through the official controls. [Am. 7]

(21)

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

(22)

Member States should be allowed to confer upon designated competent authorities the responsibility for official controls in relation to Union rules, including rules regarding alien species which may harm agricultural production or the environment by their invasive character, other than those falling within the scope of this Regulation.

(23)

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 public authorities which act in the public interest, are and ensure the quality, consistency and effectiveness of official controls. The designated competent authority, or authorities, should be appropriately resourced and equipped, and offer guarantees of Member States should be able to guarantee their impartiality and professionalism. Competent authorities should ensure the quality, consistency and effectiveness of official controls. by ensuring their independence from any operator operating within the agri-food chain . [Am. 8]

(24)

The correct application and enforcement of the rules falling within the scope of this Regulation requires appropriate knowledge of both such 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, according to their area of competence, as well as on the obligations resulting from this Regulation.

(24a)

The audits undertaken by the competent authorities, or at the request of the competent authorities, to ensure compliance with this Regulation may be based on international standards, where the requirements of those standards correspond to the requirements of this Regulation. [Am. 9]

(25)

Operators should have a the right to appeal against the decisions taken by the competent authorities, and be informed of such a . The competent authorities are to inform operators of this right. [Am. 10]

(26)

The competent authorities should ensure that , with the exception of internal reporting obligations, staff responsible for official controls do not disclose information acquired during the performance of such controls where that information is covered by professional secrecy. Unless there is an overriding interest justifying disclosure, professional secrecy should include information which would undermine the purpose of inspections, investigations or audits, the protection of commercial interests and the protection of court proceedings and legal advice. However, professional secrecy should not prevent competent authorities from disclosing Where there is a suspicion of risk to human or animal health or of other serious breaches of food law, the competent authorities should take suitable steps to inform the public. The measures taken should be in proportion to the scale of the infringement, in particular when naming specific products or operators concerned. Factual information on the outcome of an official controls control regarding individual operators may be divulged when the operator concerned has been allowed to comment upon it prior to the disclosure and such comments have been taken into account, or and released alongside and at the same time as the information being divulged by the competent authorities. The need to respect professional secrecy is also without prejudice to the obligation to inform the general public where there are reasonable grounds to suspect that food or feed may present a risk for health in accordance with Article 10 of Regulation (EC) No 178/2002. The obligation for competent authorities to inform the general public in cases where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health, in accordance with Article 10 of Regulation (EC) No 178/2002, and 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 (10) should not be affected by this Regulation. [Am. 11]

(27)

Competent authorities should perform official controls regularly, 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. In some cases, however, Union agri-food chain legislation requires that official controls be performed irrespective of the level of risk or expected non-compliance 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. In such cases the frequency of the official controls is dictated by the certification or attestation needs.

(28)

To preserve the effectiveness of official controls in the verification of compliance, no warning should be given prior to performing controls, unless the nature of the official control activities requires otherwise, as is the case in particular for audit activities.

(29)

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 what is necessary for the performance of efficient and effective official controls.

(29a)

Official controls should be performed by staff free from any conflict of interests, and in particular not engaged, directly or through a spouse, in an economic activity that is subject to the official controls laid down. [Am. 12]

(30)

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 of animals and goods which are to be moved or placed on the market in another Member State or exported outside the Union. In the latter case, 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.

(31)

To ensure that the Union agri-food chain rules are 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 such rules. 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 agri-food chain rules (for example, of veterinary medicinal products) insofar as this is necessary to fully investigate possible violations of those rules and to identify the cause of any such violation.

(32)

The competent authorities act in the interest of operators and of the general public by 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 rules is ascertained across the entire agri-food chain through official controls. The competent authorities 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 therefrom. 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.

(33)

It is of the utmost importance that competent authorities 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 detailed information and instructions to staff performing official controls. They should also have appropriate procedures and mechanisms in place to continuously verify that their own action is effective and consistent, and take corrective action when shortcomings are identified.

(34)

To facilitate the identification of non-compliance and streamline the taking of corrective action by the operator concerned, the outcome of official controls which identify non-compliance with the rules should be recorded in a report,. A copy of which that report should also be given to the operator. Where official controls require the continuous or regular presence of the staff of the competent authorities to monitor the operator's activities, a report of each individual inspection or visit to the operator would be disproportionate. In such cases, reports should be prepared with a frequency that enables the competent authorities and the operator to be regularly informed of the level of compliance and immediately notified of any identified shortcomings. In the interests of reducing the administrative burden, it should also be sufficient to record the outcome of official controls at border control posts in the Common Health Entry Document. [Am. 13]

(35)

Operators should cooperate fully with competent authorities and delegated bodies to ensure the smooth performance of official controls and to enable the competent authorities to perform other official activities.

(36)

This Regulation establishes a single legislative framework for the organisation of official controls to verify compliance with agri-food chain rules in all the areas that such rules cover. 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, 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 minimum frequencies for those controls, specific or additional measures to those provided for in this Regulation that competent authorities should take in relation to non-compliances, 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 mechanisms 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 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.

(37)

The competent authorities should be able to delegate some of their tasks to other bodies. Appropriate conditions should be laid down to guarantee 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 ISO standard for the performance of inspections.

(38)

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 state-of-the-art 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 the International Organisation for Standardisation (ISO), the European and Mediterranean Plant Protection Organisation (EPPO), the International Plant Protection Convention (IPPC), the World Organisation for Animal Health (OIE), European Union and national reference laboratories, or national rules.

(39)

Operators whose animals or goods are subject to sampling, analysis, test or diagnosis in the context of official controls should have the right to apply for a second expert opinion which should include the taking of a second sample for the purposes of counter-analysis, counter-test or counter-diagnosis unless any such second sampling 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. The IPPC for that reason rejects the use of counter-samples for assessing the presence of quarantine organisms in plants or plant products.

(40)

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.

(41)

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 (11).

(42)

While accreditation is the instrument of choice to ensure state-of-the-art 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, in cases where the analyses or tests performed only concern qualitative aspects of plant reproductive material, 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.

(43)

In order to ensure flexibility and proportionality of 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. Moreover, accreditation of a laboratory for all the methods it should use as official laboratory might not be immediately available in certain cases where new or recently modified methods should be used, and 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.

(44)

Official controls performed on animals and goods entering the Union from third countries are of key importance to ensure that they comply with legislation applicable within the Union and, in particular, with the rules established to protect across the Union human, animal and plant health, animal welfare and, as regards GMOs and plant protection products, the environment. Such official controls should take place as appropriate before or after the animals or goods are released for free circulation within the Union. The frequency of official controls should adequately address risks to health, animal welfare and to the environment, that animals and goods entering the Union could pose, taking into account the history of compliance with the requirements provided for in Union agri-food chain rules, 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.

(45)

Given the risks to human, animal or plant health, animal welfare or to the environment that certain animals or goods may pose, those aniamls or goods should be subject to specific official controls to be performed upon them at 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 at 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 the provisions of Council Directive 97/78/EC (12), Council Directive 91/496/EEC (13), Council Directive 2000/29/EC (14) and Commission Regulation (EC) No 669/2009 (15), should be provided for in this Regulation.

(46)

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 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 at their entry into the Union.

(47)

Official controls performed at border control posts should include documentary and identity checks on all consignments and physical checks performed at a frequency dependent on the risk posed by each consignment of animals or goods.

(48)

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, to the environment. This approach should enable the competent authorities to allocate control resources 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 of the consignments entering the Union. The risk-based approach to identity and physical checks should be pursued by making full use of available data sets and information, and of computerised data collection and management systems.

(49)

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

(50)

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 result 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.

(51)

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 entities should be withdrawn or suspended when they no longer comply with those requirements or when their activities may pose a risk to human, animal or plant health, animal welfare or, in the case of GMOs and plant protection products, to the environment.

(52)

To guarantee 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 case of suspicion of non-compliance, and in relation to non-compliant consignments and of consignments which could pose a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, to the environment.

(53)

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

(54)

Member States should be required to 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 rules, the system of own controls that they put in place for that purpose needs to 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, at a level appropriate to the enforcement needs at any given moment. To reduce the dependency of the official control system from public finances, competent authorities should be able to collect fees or contributions to costs 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 and plant reproductive material. Fees or contributions to costs 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. [Am. 14]

(55)

Fees should cover, but not exceed, the costs incurred by the competent authorities to perform 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 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 will chose for the calculation of the fees, when these are calculated on the basis of overall costs incurred by the competent authorities over a given period of time, and charged on all operators irrespective of whether they are subject to an official control during the reference period, those fees should be calculated so as to reward operators with a consistent good record of compliance with Union food chain legislation.

(56)

The direct or indirect refund of fees collected by the competent authorities should be prohibited as it would put operators not benefitting from the refund at a disadvantage and potentially create distortions of competition. However, in order to provide support to micro-enterprises, these should be exempted from the payment of the fees collected in accordance with this Regulation.

(57)

The financing of official controls through fees collected from operators should occur in full transparency, so as to enable citizens and businesses to understand the method and data used to establish fees and be informed on the use of fees revenue.

(58)

Union agri-food chain rules establish 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.

(59)

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 should 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. It is appropriate to lay down a minimum set of rules ensuring that also the issuance of official attestations is performed according to appropriate guarantees of reliability.

(60)

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 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.

(60a)

Regulations (EC) No 1829/2003  (16) and (EC) No 1831/2003  (17) of the European Parliament and of the Council 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. Experience shows that knowledge and expertise in the testing, evaluation and validation of methods in the context of the authorisation procedure is crucial in order to provide a high-level, state-of-the-art contribution to the efficiency of official controls. Laboratories designated as such under Regulations (EC) No 1829/2003 and (EC) No 1831/2003 should therefore act as European Union reference laboratories for the purposes of this Regulation. [Am. 16]

(61)

For the performance of official controls and other official activities on the production and marketing of plant reproductive material, 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 areas. For that purpose the Commission should be able to designate, and rely on the expert assistance of, European Union reference centres for plant reproductive material and for animal welfare. [Am. 17]

(62)

In order to pursue the objectives of this Regulation and contribute to the smooth functioning of the internal market, ensuring consumer confidence in it, non-compliances with Union 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 by 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, or in the case of food fraud, for the purpose of enabling rapid measures to be taken to counter those risks. However, that instrument, while allowing for timely action across all Member States concerned to counter certain serious risks along the 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 agri-food chain rules. [Am. 18]

(63)

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 streamline and simplify cooperation amongst Member States the Commission should 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.

(64)

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 risk-based and efficient manner across their territory and across the entire agri-food chain, and in compliance with this Regulation.

(65)

In order to guarantee the coherence and completeness of MANCPs Member States should designate a single authority responsible for their coordinated preparation and implementation. In order to promote a consistent, uniform and integrated approach to official controls, the Commission should have the power to adopt rules concerning MANCPs which should identify priorities for official controls, effective control procedures, criteria for risk categorisation and performance indicators for assessing MANCPs.

(66)

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 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, the Commission should be able to adopt implementing acts in respect of establishing standard model forms for annual reports.

(67)

Commission experts should be able to perform controls in Member States to verify the application of 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.

(68)

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 rules. This principle is enshrined in 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. Concerning plant reproductive material, an equivalence system is in place whereby third countries from which plant reproductive material can be imported are authorised and listed.

(69)

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 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.

(70)

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, 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.

(71)

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, 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 be also addressed to staff of the competent authorities in third countries.

(72)

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 of staff tasked with official controls or other official activities.

(73)

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 Decision 2003/24/EC (18) and currently used for the management of data and information on animals and products of animal origin and official controls thereon. That system should be upgraded and adapted so as to allow its use for all goods for which Union agri-food chain legislation establishes specific requirements or official control modalities. 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 food chain or for animal and plant health. Regulation (EC) No 178/2002 establishes the RASFF, Regulation (EU) …/…. (*2) a system for the notification and reporting on the measures on listed diseases and on food fraud , and Regulation (EU) …/…. (*3) a system for the notification and reporting of the presence of pests and the notification of non-compliances. All such systems should work in a harmonious, consistent manner that makes use of synergies between the different systems, avoids duplications, simplifies their operation and makes them more efficient. [Am. 19]

(74)

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 of such computerised system with other information systems operated by public authorities and through which relevant data is exchanged or made available. Moreover, the possibility to use the electronic signatures within the meaning of Directive 1999/93/EC of the European Parliament and the Council (19) should be laid down, in line with the Digital Agenda for Europe.

(74a)

In order to minimise administrative burdens and control costs and in order to allow the Union and its Member States to effectively communicate electronically in trade relations with third countries, it is necessary that when exchanging electronic certificates or other electronic data, the Commission and the competent authorities of the Member States use internationally standardised language, message structure and exchange protocols based on guidance for electronic certification in standardised World Wide Web Consortium (WC3) Extensible Markup Language (XML schemas) as well as secure exchange mechanisms between competent authorities as is provided by the UN Centre for Trade Facilitation and Electronic Business (UN/CEFACT). [Am. 20]

(75)

The competent authorities should investigate cases where there is a suspicion of non-compliance with Union agri-food legislation and, where non-compliance is established, determine its origin and extent as well as the operators' responsibilities. They should also take appropriate measures to ensure that the operators concerned remedy the situation and to prevent further non-compliance.

(76)

The verification of compliance with 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. Failures 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 and, as regards GMOs and plant protection products, to the environment, independently of the involvement or responsibility of operators or other actors, or lead to situations of serious widespread non-compliance with food chain rules. The Commission should therefore be able to react to serious failures in a Member State's control system by adopting measures aimed at containing or eliminating those risks from the agri-food chain pending the necessary action to be taken by the concerned Member State to make good the failure in the control system.

(77)

Infringements of the rules should be subject to effective, dissuasive and proportionate sanctions at national level throughout the Union. For financial penalties applicable to intentional infringements to be sufficiently dissuasive, they should be set at a level which is likely to offset of at least double the economic advantage sought by the perpetrator through the violation. Member States should also be required to apply appropriate criminal or administrative penalties, or both, in cases where operators fail to cooperate during an official control. [Am. 21]

(77a)

Account should be taken of the specific needs of the developing countries, in particular the least developed countries, which should be given support in organising their official controls so that they can meet the criteria for the import of animals and goods into the Union. [Am. 22]

(78)

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 the rules of this Regulation: Council Directive 89/608/EEC (20), Council Directive 89/662/EEC (21), Council Directive 90/425/EEC (22), Council Directive 91/496/EEC, Council Decision 92/438/EEC (23), Council Directive 96/23/EC, Council Directive 96/93/EC (24), Council Directive 97/78/EC and Regulation (EC) No 882/2004; and Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption  (25) . [Am. 23]

(79)

In order to ensure consistency, amendments should also be effected to the following acts: Regulation (EC) No 999/2001 of the European Parliament and of the Council (26), Council Regulation (EC) No 1/2005 (27), Regulation (EC) No 396/2005 of the European Parliament and of the Council (28), Council Regulation (EC) No 834/2007 (29); Regulation (EC) No 1069/2009; Council Regulation (EC) No 1099/2009 (30), Regulation (EC) No 1107/2009 of the European Parliament and of the Council (31), Regulation (EU) No 1151/2012 of the European Parliament and of the Council (32), Council Directive 98/58/EC (33), Council Directive 1999/74/EC (34), Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003, Council Directive 2007/43/EC (35), Council Directive 2008/119/EC (36), Council Directive 2008/120/EC (37) and Directive 2009/128/EC of the European Parliament and of the Council (38). [Am. 24]

(80)

Regulation (EU) No …/… (*4) 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 …/… (*5) should be amended to take account of the changes introduced by this Regulation to Regulation (EC) No 882/2004.

(81)

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, inter alia, 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 and physical checks, on the establishment of conditions to be met by certain animals or goods entering the Union from third countries, on additional requirements and tasks of European Union reference laboratories and centres, on additional requirements for national reference laboratories, on criteria for risk categorisation and for performance indicators for the MANCPs, and on the contingency plans for food and feed provided for in Regulation (EC) No 178/2002, the power to adopt acts in accordance with Article 290 of the Treaty 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. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

(82)

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 plant reproductive material 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 violations of agri-food chain rules which require coordinated assistance and follow-up by the Commission, implementing powers should be conferred on the Commission.

(83)

In order to ensure uniform conditions for the implementation of this Regulation, including, inter alia, rules and modalities 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 products 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, 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 (39).

(84)

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 rules, cannot be sufficiently achieved by the Member States but can therefore, 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 exceed what is necessary in order to achieve that objective,

(a)

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

(b)

the financing of official controls;

(c)

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

(d)

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

(e)

the adoption of conditions to be met by animals and goods entering the Union from a third country;

(f)

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

(a)

governing food and, food safety, food quality and food wholesomeness, at any stage of production, the processing and distribution of food, including rules aimed at guaranteeing 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;

(b)

governing the deliberate release into the environment and the contained use of GMOs;

(c)

governing feed and feed safety, at all stages of production, processing and distribution of feed and the use of feed, including rules aimed at guaranteeing fair practices in trade and protecting consumer health, interests and information;

(d)

laying down animal health requirements;

(e)

aiming at preventing and minimising risks to human and animal health arising from animal by-products and derived products;

(ea)

aiming at preventing and minimising antimicrobial resistance in animals and humans, as well as in the environment;

(f)

laying down welfare requirements for animals;

(g)

on protective measures against pests of plants;

(h)

on the production, with a view to placing on the market, and placing on the market of plant reproductive material;

(i)

laying down requirements for the placing on the market and use of plant protection products and the sustainable use of pesticides;

(j)

governing organic production and labelling of organic products;

(k)

on the use and labelling of protected designations of origin, protected geographical indications and traditional specialities guaranteed;

(ka)

laying down requirements on monitoring certain substances and residues thereof in live animals and animal products. [Ams. 25, 26 and 27]

(a)

entering the Union from third countries;

(b)

to be exported to third countries.

(a)

Regulation (EC) No 1234/2007 in areas other than those under Part II, Title II, Chapter I of that Regulation . However, this Regulation shall apply to official controls on protected designations of origin and protected geographical indications for wine ; [Am. 28]

(b)

Directive 2010/63/EU of the European Parliament and of the Council (40);

(ba)

Directive 2001/82/EC of the European Parliament and of the Council  (41) . [Am. 29]

(1)

‘official control’ means any form of control , also including controls of requirements for animals and goods from third countries intended for export to third countries, that the competent authorities perform for the verification of compliance with: [Am. 30]

(2)

‘other official activities’ means any activity, other than an official control, which is performed by competent authorities in accordance with:

(3)

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

(4)

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

(5)

‘competent authorities’ means:

(6)

‘animals’ means animals as defined in point (1) of Article 4(1) of Regulation (EU) No …/… (*6) with the exception of ‘pets’ ; [Am. 33]

(7)

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

(8)

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

(9)

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

(10)

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

(11)

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

(12)

‘pests’ means pests as defined in Article 1(1) of Regulation (EU) No …/…. (*7);

(13)

‘plants’ means plants as defined in point (1) of Article 2 of Regulation (EU) No …/…. (*8);

14.

‘plant reproductive material’ means plant reproductive material as defined in point (2) of Article 3 of Regulation (EU) No XXX/XXXX [number, date, title and, in a footnote, the OJ reference for the Regulation on the production and making available on the market of plant reproductive material]; [Am. 34]

(15)

‘plant protection products’ means plant protection products as referred to in Article 2(1) of Regulation (EC) No 1107/2009; for the purposes of this Regulation, ‘plant protection products’ also refers to the active substances referred to in Article 2(2) of Regulation (EC) No 1107/2009 and other substances or preparations referred to in Article 2(3) of that Regulation; [Am. 35]

16.

‘alien species’ means a species, subspecies or lower taxon, introduced outside its natural past or present distribution and includes any part, gametes, seeds, eggs, or propagules of such species, as well as any hybrids, varieties or breeds, that might survive and subsequently reproduce; [Am. 36]

(17)

‘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 (42);

(18)

‘germinal products’ means germinal products as defined in point (25) of Article 4(1) of Regulation (EU) No …/…. (*9);

(19)

‘plant products’ means plant products as defined in point (2) of Article 2 of Regulation (EU) No …/…. (*10);

(20)

‘other objects’ means other objects as defined in point (4) of Article 2 of Regulation (EU) No …/…. (*11);

(21)

‘risk assessment’ means risk assessment as defined in point (11) of Article 3 of Regulation (EC) No 178/2002;

(22)

‘certifying officer’ means:

(23)

‘official certificate’ means any 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);

(24)

‘non-compliance’ means non-compliance with:

(25)

‘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 the rules referred to in Article 1(2); [Am. 37]

(26)

‘operator’ means any natural and legal person subject to one or more obligations provided for in the rules referred to in Article 1(2), except the competent authorities and the other bodies in charge of official controls and other official activities;

(27)

‘consignment’ means a number of animals or quantity of goods of the same type, class, or description, covered by the same official certificate, official attestation or any other document, conveyed by the same means of transport and having the same origin; it may consist of one or more lots;

(28)

‘inspection’ means a form of official control involving the examination of:

(29)

‘border control post’ means a place an inspection centre , and the facilities belonging to it, designated by a Member State to perform the official controls provided for in Article 45(1); [Am. 40]

(30)

‘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 objectives;

(31)

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

(32)

‘official veterinarian’ means a veterinarian appointed by the competent authorities and appropriately qualified to perform the official controls and other official activities in accordance with: [Am. 42]

(33)

‘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;

(34)

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

(35)

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

(36)

‘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;

(37)

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

(38)

‘delegated body’ means an independent third party, to which the competent authorities have delegated specific official control tasks relating to official controls and other official activities ; [Am. 43]

(39)

‘control authority for organic products production ’ means a public administrative organisation of a Member State to which the competent authorities have conferred, in whole or in part, their competences for inspections and certification in the organic production sector, in relation to Regulation (EC) No 834/2007, including, where appropriate, the corresponding authority of a third country or operating in a third country; [Am. 44]

(40)

‘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;

(41)

‘screening’ means a form of official control performed by conducting a planned sequence of observations or measurements with a view to obtaining an overview of the state of compliance with this Regulation and the rules referred to in Article 1(2);

(42)

‘targeted screening’ means a form of official control involving observation of one or more operators or their activities;

(43)

‘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 provided for in Articles 15 to 24;

(44)

‘equivalence’ or ‘equivalent’ means: systems that are broadly the same and meet the same objectives; [Am. 45]

(45)

‘entry into the Union’ means the action of bringing animals and goods into one of the territories listed in Annex I;

(46)

‘documentary check’ means the examination of the official certificates, official attestations and other document or 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), Article 54(1), or by implementing acts adopted in accordance with Articles 75(3), 125(4), 127(1) and 128(1);

(47)

‘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 with the information provided in the official certificates, official attestations and other documents accompanying it;

(48)

‘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);

(49)

‘transhipment’ means the movement of goods or animals subject to the official controls provided for in Article 45(1) which arrive by sea or by air transport from a third country 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; [Am. 48]

(50)

‘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 passing through the territory of a third country;

(51)

‘supervision by the customs authorities’ means action as defined in Article 4(13) of Council Regulation (EEC) No 2913/92 (43);

(52)

‘control by the customs authorities’ means customs controls as defined in Article 4(14) of Regulation (EEC) No 2913/92;

(53)

‘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; [Am. 49]

(54)

‘additional official controls’ means those controls which were not originally planned and which were decided on the basis of the findings of previous official controls, or other official activities;

(55)

‘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;

(56)

‘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 in each of the areas referred to in Article 1(2) over a period of time;

(57)

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

(57a)

‘ Official auxiliary’ means a person qualified, in accordance with Annex IIIa to this Regulation, to act in such a capacity, appointed by the competent authority and working under the authority and responsibility of an official veterinarian. [Am. 50]

(a)

put in place procedures are put in place to ensure efficient and effective coordination between all authorities involved, and the consistency and effectiveness of official controls or other official activities across the whole of its territory; [Am. 53]

(b)

designation of a single authority responsible to coordinate the cooperation and the contacts with the Commission and other Member States in relation to the official controls and other official activities performed in that area each of the sectors defined by the Member State, in such a way as to cover all the areas referred to in Article 1(2) . [Am. 54]

(a)

the competent authorities designated in accordance with paragraph 1;

(b)

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

(c)

the control authorities for organic products referred to in paragraph 3;

(d)

the delegated bodies referred to in Article 25(1).

(a)

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

(b)

arrangements in place to ensure the impartiality, independence , quality, consistency and unity of purposes of official controls and other official activities at all levels; they should be in no way connected to or dependent of the operators that they control;

(c)

arrangements in place to ensure that staff performing official controls and other official activities are independent, impartial, and free from any conflict of interest , and have no improper connection from which they stand to make economic gain or which might jeopardise their impartiality ;

(d)

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

(e)

or have access to, a sufficient number of independent, suitably qualified and experienced staff with regard to the control requirements under Article 1(1) and (2), so that official controls and other official activities can be performed fully, efficiently and effectively;

(f)

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

(g)

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);

(h)

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;

(i)

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).

(-a)

be officials employed by the competent authorities or by an independent public body delegated by the competent authority to perform official controls or other official activities;

(a)

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;

(b)

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

(c)

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.

(a)

subject to independent scrutiny;

(b)

carried out in a transparent manner.

(a)

the purpose of inspections, investigations or audits;

(b)

the protection of commercial interests of a natural or legal person;

(c)

the protection of ongoing court proceedings and legal advice;

(ca)

the decision-making process of competent authorities.

(a)

possible risks to human, animal or plant health, or to the environment;

(b)

the nature, severity and extent of such risks, so as to ensure that disclosure is proportionate in the circumstances.

(a)

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 the publication or release;

(b)

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 simultaneously and together with such comments.

(a)

identified risks associated with:

(b)

operators undertakings ' past record as regards the results of official controls performed on them and their compliance with the rules referred to in Article 1(2); [Am. 66]

(c)

the reliability and results of own controls that have been performed by the operators, or by a third party at their request, for the purpose of ascertaining compliance with the rules referred to in Article 1(2) . Transfer of information on these own controls shall be utilised as much as possible, in a manner that minimizes the burden on operators ; [Am. 67]

(ca)

consumer expectations regarding nature, quality and composition of foods and goods; [Am. 68]

(d)

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

(da)

private quality assurance schemes put in place by operators, which are certified and audited by independent and recognised certification bodies. [Am. 69]

(a)

the rules referred to in Article 1(2);

(b)

the delegated acts adopted by the Commission in accordance with Articles 15 to 24.

(a)

prior notification of the operator is necessary; [Am. 72]

(b)

the operator has requested such official controls. Such announced controls shall not replace standard controls without prior warning; [Am. 73]

(ba)

audits for verification of requirements in accordance with point (j) of Article 1(2) are performed. [Am. 74]

(a)

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

(b)

to be exported from the Union;

(c)

entering the Union from third countries.

(a)

on animals and goods at all stages of production, processing , marketing, and distribution; [Am. 78]

(b)

on substances, materials or other objects which may influence the characteristics or health of animals and goods, at all stages of production, processing and distribution;[Am. 79]

(c)

on operators and the activities and operations under their control, on their premises , land, crops and processes, on the storage, transport, and the use of goods and on the keeping of animals; [Am. 80]

(ca)

on all documentation, including documentation kept in electronic form, linked to the activity being performed, or to operations including transport. [Am. 81]

(a)

type, number and final outcome of official controls;

(b)

type and the number of non-compliances detected;

(c)

type and number of cases where measures were taken by the competent authorities in accordance with Article 135;

(d)

type and number of cases where the penalties referred to in Article 136 were imposed. [Am. 82]

(a)

the rating criteria are objective, transparent and publicly available;

(b)

appropriate arrangements are in place to ensure the consistency and transparency of the rating process;

(ba)

subsequent inspections are carried out without delay if the findings are unfavourable. [Am. 84]

(a)

take corrective actions in all cases where the procedures provided for in paragraph 2 identify shortcomings in the consistency and effectiveness of official controls and other official activities;

(b)

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

(a)

a description of the purpose of the official controls;

(b)

the control methods applied;

(c)

the results of the official controls;

(d)

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

(a)

regularly informed of the level of compliance;

(b)

immediately informed of any shortcoming or non-compliance identified through the official controls.

(a)

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

(b)

an inspection of:

(c)

controls on the hygiene conditions in the operators’ premises;

(d)

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

(e)

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); [Am. 91]

(f)

interviews with operators and with their staff;

(g)

a reading of values recorded by operators' measuring instruments;

(h)

controls performed with the competent authorities' own instruments to verify measurements taken by operators;

(i)

any other activity required to identify non-compliance.

(a)

their premises;

(b)

their computerised information management systems;

(c)

their animals and goods;

(d)

their relevant documents and any other relevant information , including the results of potential own tests, that is relevant for the purpose of performing such controls or activities and the control subjects listed in Article 13(2) . Every operator shall be able to indicate at least each operator he is supplied by and each operator he is supplying . [Am. 93]

(a)

cooperate fully with the competent authorities to ensure the efficient performance of official controls or other official activities;

(b)

make available without delay all requested information concerning the consignment on paper or electronically. [Am. 95]

(a)

establishing the modalities for access by the competent authorities and the delegated bodies, pursuant to Article 25, to the computerised information management systems referred to in paragraph 1(b); [Am. 96]

(b)

on the cooperation between operators and competent authorities as referred to in paragraph 3.

(a)

the design and maintenance of premises and equipment;

(b)

personal hygiene;

(c)

HACCP-based procedures;

(d)

own-controls procedures;

(e)

verification of compliance by the staff with applicable requirements;

(f)

verification of the operator’s records and of documents accompanying food, feed and any substance or material entering and leaving the establishment;

(g)

consideration of any evidence of the presence of fraudulent practices.

(a)

the verification by or under the responsibility of an official veterinarian, of the health and welfare of the animals prior to the slaughter or by an official auxiliary working under an official veterinarian's responsibility ;

(b)

official controls by or under the responsibility of an official veterinarian or by an official auxiliary working under an official veterinarian's responsibility , in slaughterhouses, cutting and processing plants and game handling establishments, to verify compliance with the requirements applicable to:

(a)

at least one official veterinarian shall be present during both the ante-mortem and post-mortem inspection or, in the case of game-handling establishments, during the post-mortem inspection;

(b)

an official veterinarian or an official auxiliary shall be present, with a frequency appropriate to achieving the objectives of this Regulation, in cutting plants when meat is being worked on.

(a)

the specific responsibilities and tasks of the competent authorities, in addition to those provided for in paragraph 1 and in Article 4, Articles 8 and 9, Article 10(1), Articles 11 to 13, Article 34(1) and (2), and Article 36;

(b)

uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls, having regard, in addition to the criteria referred to in Article 8(1), to the specific hazards and risks which exist in relation to each product of animal origin and the different processes it undergoes;

(c)

the cases where and the conditions under which slaughterhouse staff may be involved in official controls appropriately qualified and trained, and employed under the control of the official veterinarian in a unit which is segregated and independent from the production units of the establishment, may assist the official veterinarian when performing the official controls referred to in paragraph 2 in relation to the production of meat from poultry and largomorphs , and the design and application of tests to assess their performance;

(d)

the circumstances in which the competent authorities in relation to specific cases of non-compliance are to take one or more of the measures referred to in Article 135(2) or additional measures to those provided for in that paragraph;

(e)

criteria to determine when, on the basis of a risk analysis, the conditions and the frequency of the official control tasks to be carried out by the official veterinarian is not required to be present in low throughput slaughterhouses and in game handling establishments, during the official controls referred to respecting the minimum requirement laid down in paragraph 1 1a (a) .

(a)

the experience gained by competent authorities and food business operators on the application of the procedures referred to in Article 5 of Regulation (EC) No 852/2004;

(b)

scientific and technological developments;

(c)

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

(d)

risks to human health and animal health associated with meat and other products of animal origin intended for human consumption;

(da)

consideration of any evidence of the presence of fraudulent practices.

(a)

the need to facilitate the application of for the delegated acts in to be commensurate with the nature and the size of small businesses to ensure an effective application ; [Am. 97]

(b)

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

(c)

the needs of food businesses situated in regions that are subject to special geographic constraints.

(a)

uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls, having regard, in addition to the criteria referred to in Article 8(1), to the specific hazards and risks related to non-authorised substances and to the non-authorised use of authorised substances;

(b)

specific additional criteria and specific additional content to those provided for in Article 108, for the preparation of the relevant parts of the multi-annual national control plan provided for in Article 107(1);

(c)

the cases where the competent authorities in relation to specific non-compliances are to take one or more of the measures referred to in Article 135(2) or additional measures to those provided for in that paragraph.

(a)

verification of measures for protection against biological and chemical hazards to human and animal health;

(b)

verification of animal welfare measures, without prejudice to Article 18;

(c)

verification of disease control or eradication measures. [Am. 99]

(a)

the specific responsibilities and tasks of the competent authorities, in addition to those provided for in Article 4, 8, 9, 10(1), Articles 11 and 12, 13, and Article 34(1) and (2) and 36; [Am. 101]

(b)

uniform specific requirements for the performance of official controls, and uniform minimum frequency of such official controls, having regard, in addition to the criteria referred to in Article 8(1), to the need to address specific hazards and risks to 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);

(c)

the cases where the competent authorities in relation to cases of specific non-compliance are to take one or more of the measures referred to in Article 135(2) or additional measures to those provided for in that paragraph.

(a)

in 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;

(b)

in 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, prior to the journey:

(c)

at border control posts provided for in Article 57(1) and at exit points:

(ca)

in case of long journeys between Member States and with third countries, official controls performed at any stage of the long journey on a random or targeted basis to verify that declared journey times are realistic and that the journey complies with Regulation (EC) No 1/2005 and in particular that travel times and rest periods have complied with the limits set out in Chapter V of Annex I to Regulation (EC) No 1/2005. [Am. 106]

(a)

the specific responsibilities and tasks of the competent authorities, in addition to those provided for in paragraph 1 and Article 4, Articles 8 and 9, Article 10(1) and Articles 11 to 13, 34(1) and (2), and 36; [Am. 108]

(b)

uniform specific requirements for the performance of official controls, and uniform minimum frequency of such official controls, having regard, in addition to the criteria referred to in Article 8(1), 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;

(c)

the cases where the competent authorities in relation to specific non-compliances are to take one or more of the measures referred to in Article 135(2) or additional measures to those provided for in that paragraph;

(d)

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

(e)

specific criteria and conditions for the activation of the mechanisms of administrative assistance provided for in Title IV;

(f)

the cases and conditions where official controls to verify compliance with animal welfare requirements may shall 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. [Am. 109]

(a)

specific responsibilities and tasks of the competent authorities, in addition to those provided for in Article 4, Articles 8 and 9, Article 10(1), Articles 11 to 13, Article 34(1) and (2), and Article 36;

(b)

uniform specific requirements for the performance of 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) and uniform minimum frequencies of such official controls having regard, in addition to the criteria referred to in Article 8(1), to the specific hazards and risks to plant health in relation to specific plants, plant products and other objects of a particular origin or provenance;

(c)

uniform frequencies of official controls performed by competent authorities on operators authorised to issue plant passports in accordance with Article 79(1) of Regulation (EU) No …/…. (*12) having regard, in addition to the criteria referred to in Article 8(1), to whether those operators have implemented a phytosanitary risk management plan as referred to in Article 86 of Regulation (EU) No …/…. (*13) for the plants, plant products and other objects they produce;

(d)

the cases where the competent authorities in relation to specific non-compliances are to take one or more of the measures referred to in Article 135(2) or additional measures to those provided for in that paragraph.

(a)

the specific responsibilities and tasks of the competent authorities, in addition to those provided for in Articles 4, 8, 9, 10(1), 11, 12, 13, 34(1) and (2), and 36;

(b)

uniform specific requirements for the performance of official controls having regard, in addition to the criteria referred to in Article 8(1), to the risks to the health, identity, quality and traceability of certain categories of plant reproductive material or of specific genera or species;

(c)

specific criteria and conditions for the activation of the mechanisms of administrative assistance provided for in Title IV;

(d)

the cases where the competent authorities in relation to specific non-compliances are to take one or more of the measures referred to in Article 135(2) or additional measures to those provided for in that paragraph. [Am. 110]

(a)

specific responsibilities and tasks of the competent authorities, in addition to those provided for in Article 4, Articles 8 and 9, Article 10(1), Articles 11 to 13, Article 34(1) and (2), and Article 36;

(b)

uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls on:

(c)

the circumstances in which the competent authorities in relation to specific cases of non-compliance are to take one or more of the measures referred to in Article 135(2) or additional measures to those provided for in that paragraph.

(a)

the specific responsibilities and tasks of the competent authorities, in addition to those provided for in Article 4, Articles 8 and 9, Article 10(1), Articles 11 to 13, Article 34(1) and (2), and Article 36;

(b)

uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls, concerning the manufacture, placing on the market, entry into the Union, labelling, packaging, transport, storage , parallel trade and use of plant protection products, having regard, in addition to the criteria referred to in Article 8(1), to the need to ensure the safe and sustainable use of plant protection products and to combat illegal trade of such products; [Am. 116]

(c)

uniform specific requirements for inspections on pesticide application equipment and uniform minimum frequency of such controls;

(ca)

uniform specific requirements for the establishment of a register or database concerning production, packaging and storage facilities; [Am. 117]

(d)

the cases where the competent authorities in relation to specific non-compliances are to take one or more of the measures referred to in Article 135(2) or additional measures to those provided for in that paragraph;

(e)

the design of certification systems to assist the competent authorities in the inspections of pesticide application equipment;

(f)

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

(g)

the collection of information, and the monitoring of and reporting on counterfeited plant protection products and illegal trade of plant protection products.

(a)

the specific responsibilities and tasks of the operators, the competent authorities, the delegated bodies to ensure compliance with the provisions of Regulation (EC) No 834/2007, in addition to those provided for in Article 4, Articles 8 and 9, Article 10(1), Articles 11 to 13, Article 34(1) and (2), and Article 36, and in addition to Articles 25, 29, 30 and 32 for the approval and supervision of delegated bodies; [Am. 119]

(b)

additional requirements to those referred to in Article 8(1) for risk assessment, and for the establishment of the frequency of official controls, and of sampling as appropriate, taking into account the risk of the occurrence of non-compliance;

(c)

the minimum frequency of official controls on operators as defined in point (d) of Article 2 of Council Regulation (EC) No 834/2007, and the cases where and the conditions under which certain such operators are to be exempted from certain official controls;

(d)

additional methods and techniques for official controls to those referred to in Article 13 and Article 33(1) to (5) and specific requirements for the performance of official controls aimed at ensuring the traceability of organic products at all stages of the production, preparation and distribution, and at providing assurances as to compliance with the rules referred to in point (j) of Article 1(2);

(e)

additional criteria to those referred to in the second subparagraph of Article 135(1) and in Article 30(1) of Regulation (EC) No 834/2007, relating to the measures to be taken in case of the occurrence of non-compliance, and additional measures to those provided for in Article 135(2);

(f)

additional requirements to those provided for in point (f) of Article 4(1) in relation to the facilities and equipment necessary to carry out official controls and additional conditions and obligations to those referred to in Articles 25 to 30 and Article 32 for the delegation of official control tasks;

(g)

additional reporting obligations to those referred to in Articles 12 and 31 for the competent authorities, the control authorities for organic products, and the delegated bodies in charge of official controls;

(h)

specific criteria and conditions for the activation of the mechanisms of administrative assistance provided for in Title IV.

(a)

additional requirements, methods and techniques to those referred to Articles 11 and 13 for official controls performed to verify compliance with product specifications and labelling requirements;

(b)

additional methods and techniques to those referred in Article 13 for the performance of official controls aimed at ensuring the traceability of products falling within the scope of the rules referred to in point (k) of Article 1(2) at all stages of production, preparation and distribution, and at providing assurances as to compliance with those rules;

(c)

specific additional criteria and specific additional content to those provided for in Article 108, for the preparation of the relevant parts of the multi-annual national control plan provided for in Article 107(1), and specific additional content of the report provided for in Article 112;

(d)

specific criteria and conditions for the activation of the mechanisms of administrative assistance provided for in Title IV;

(e)

specific measures to be taken, in addition to those referred to in Article 135(2) in case of non-compliance and of serious or recurrent non-compliance.

(a)

the specific responsibilities and tasks of the competent authorities, in addition to those provided for in Article 4, Articles 8 and 9, Article 10(1), Articles 11 to 13, Article 34(1) and (2), and Article 36;

(b)

uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls, having regard, in addition to the criteria referred to in Article 8(1), to the specific hazards and risks which exist in relation to each category of food and feed and the different processes it undergoes;

(c)

the cases where the competent authorities in relation to specific non-compliances are to take one or more of the measures referred to in Article 135(2) or additional measures to those provided for in that paragraph.

(a)

the delegation contains a precise description of:

(b)

the delegated body:

(c)

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

(a)

communicate the results of the official controls performed by them to the competent authorities which have delegated the specific official control tasks on a regular basis and whenever those competent authorities so request;

(b)

immediately inform the competent authorities which have delegated the specific official control tasks whenever the results of the official controls indicate non-compliance or point to the likelihood of non-compliance.

(a)

organise periodic and unannounced audits or inspections of such bodies or persons as necessary; [Am. 127]

(b)

fully or partly withdraw the delegation without delay where:

(a)

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

(b)

the conditions laid down in Article 26 are fulfilled with the exception of point (b)(iv).

(a)

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

(b)

the conditions laid down in Article 26 are fulfilled with the exception of points (b)(ii) and (b)(iv).

(a)

communicate the results of the other official activities performed by it to the competent authorities which have delegated the specific tasks related to other official activities on a regular basis and whenever the competent authorities so request;

(b)

immediately inform the competent authorities which have delegated the specific tasks related to other official activities whenever the results of the other official activities indicate non-compliance or point to the likelihood of non-compliance.

(a)

organise audits or inspections of such bodies or persons as necessary; [Am. 129]

(b)

fully or partly withdraw the delegation without delay where:

(a)

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

(b)

in the absence of the rules or protocols referred to in point (a), the relevant methods developed or recommended by the European Union reference laboratories and validated in accordance with internationally accepted scientific protocols;

(c)

in the absence of the rules or protocols referred to in point (a) and the methods referred to in point (b), the methods which comply with relevant rules established at national level;

(d)

in the absence of the rules or protocols referred to in point (a), the methods referred to in point (b) and the national rules referred to in point (c), the relevant methods developed or recommended by national reference laboratories and validated in accordance with internationally accepted scientific protocols; or,

(e)

in the absence of the rules or protocols referred to in point (a), the methods referred to in point (b), the national rules referred to in point (c) and the methods referred to in point (d), the relevant methods validated in accordance with internationally accepted scientific protocols.

(a)

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

(b)

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

(c)

the interpretation of analytical, testing and diagnostic results.

(a)

shall always entitle the operator to request a documentary review of the sampling, analysis, test or diagnosis by another expert designated by the reference laboratory or, failing that, by another official laboratory which is at least equivalent ; [Am. 137]

(b)

where relevant and technically feasible, having regard in particular to the prevalence and distribution of the hazard in the animals or goods, to the perishability of the samples or the goods and to the amount of available substrate, shall entitle the operator to request and oblige the competent authorities to ensure : [Am. 138]

(a)

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

(b)

where the samples referred to in paragraph 1 are analysed or tested, are entitled to exercise the right to apply for a second expert opinion provided for in Article 34(1).

(a)

appropriate arrangements are in place under which they are enabled to perform the audits and inspections referred to in Article 38(1) or delegate the performance of such audits and inspections to the competent authorities of the Member State where the laboratory is located;

(b)

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

(a)

the tasks that the laboratory shall carry out as official laboratory;

(b)

the conditions under which it shall carry out those tasks;

(c)

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

(a)

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

(b)

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

(c)

is independent, impartial and free from any conflict of interest as regards the exercise of its tasks as official laboratory; [Am. 142]

(d)

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

(e)

operates in accordance with the standard EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’ and is assessed and accredited in accordance with that standard by a national accreditation body operating in accordance with Regulation (EC) No 765/2008. [Am. 143]

(a)

shall include all the 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;

(b)

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

(c)

may be defined in a flexible manner, so as to allow the accreditation scope 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.

(a)

on a regular basis;

(b)

any time they consider that an audit or inspection is necessary.

(a)

it no longer complies with the conditions provided for in Article 36(4) and (5);

(b)

it does not comply with the obligations provided for in Article 37;

(c)

it is underperforming at inter-laboratory comparative tests referred to in Article 37(2).

(a)

laboratories:

(b)

laboratories carrying out analyses or tests to verify compliance with the rules on plant reproductive material referred to in point (h) of Article 1(2); [Am. 147]

(c)

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

(a)

they operate, are assessed and 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;

(b)

they make regular and significant use of the methods for which they have obtained the accreditation referred to in point (a).

(a)

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

(b)

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;

(c)

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, to the environment; or

(ca)

pending the assessment by, and decision of, the accreditation body. [Am. 150]

(a)

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;

(b)

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

(c)

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

(a)

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

(aa)

the likelihood of fraudulent practices which might deceive consumer expectation regarding nature, quality and composition of foods and goods; [Am. 152]

(b)

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

(c)

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

(d)

the guarantees that the competent authorities of the third country of origin has 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.

(a)

the point of entry into the Union;

(b)

a border control post;

(c)

the point of release for free circulation in the Union;

(d)

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

(a)

means of transport, including where empty;

(b)

packaging.

(a)

always include a documentary check;

(b)

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

(a)

inform the customs authorities and the operators concerned;

(b)

decide whether or not the animals or goods can be released before the results of the analysis, test or diagnosis carried out on the samples are available, provided that the traceability of the animals or goods is ensured.

(a)

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

(b)

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

(a)

animals;

(b)

products of animal origin, foods that contain products of animal origin, germinal products and animal by-products; [Am. 153]

(c)

plants, plant products, and other objects and materials capable of harbouring or spreading pests of plants as referred to in the lists established pursuant to Articles 68(1) and 69(1) of Regulation (EU) No …/…. (*14);

(d)

goods originating from certain third countries for which the Commission has decided, by means of implementing acts provided for in point (b) of paragraph 2, 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;

(e)

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) No …/…. (*15), or Articles 27(1), 29(1), 40(2), 41(2), 47(1), 49(2) and 50(2) of Regulation (EU) No …/…. (*16) 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;

(f)

animals and goods in relation to whose entry into the Union conditions or measures have been established by acts adopted in accordance with Articles 125 or 127 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.

(a)

establish lists detailing the animals and goods belonging to the categories referred to in points (a) and (b) of paragraph 1, indicating their codes from the Combined Nomenclature;

(b)

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.

(a)

goods sent as commercial or trade samples or as display items for exhibitions, which are not intended to be placed on the market; [Am. 154]

(b)

animals and goods intended for scientific purposes; [Am. 155]

(c)

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

(d)

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

(e)

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

(f)

pet animals as defined in point (10) of Article 4(1) of Regulation (EU) No XXX/XXXX [ number of the Regulation on animal health ]; [Am. 156]

(g)

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

(h)

any other category of animals or goods for which controls at border control posts are not necessary given the risks they pose.

(a)

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 45(1) to the place of final destination pending the availability of the results of physical checks, where such checks are required;

(b)

the time limits and modalities for carrying out documentary, identity and physical checks on transhipped consignments of the categories of goods referred to in Article 45(1);

(c)

the cases where and the conditions under which identity 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;

(d)

the cases where and the conditions under which the transit of consignments of the categories of animals and goods referred to in Article 45(1) may be authorised and the specific official controls to be performed at border control posts on such consignments, including the cases and conditions for their storage in specially approved free or customs warehouses.

(a)

identity and physical checks on consignments of the categories of animals and goods referred to in Article 45(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 62(3) and in the implementing acts adopted in accordance with Article 62(4); [Am. 159]

(b)

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

(c)

specific control tasks relating to the following may be attributed by competent authorities to customs authorities or other public authorities:

(a)

performed at a reduced frequency;

(b)

limited to the verification of a consignment's official seal, where any such seal is present.

(a)

the criteria and the procedures for determining and modifying the minimum frequency rates of physical checks to be performed on consignments of the categories of animals and goods referred to in points (a), (b) and (c) of Article 45(1) and to adjust them to the level of risk associated with those categories, having regard to: [Am. 162]

(b)

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

(c)

the procedures for ensuring that the minimum frequency rates of physical checks established in accordance with point (a) are applied in a timely and uniform manner. [Am. 163]

(a)

the minimum frequency of physical checks for the categories of goods referred to in point (d) of Article 45(1); [Am. 164]

(b)

the minimum frequency of physical checks for the categories of animals and goods referred to in points (e) and (f) of Article 45(1) as long as this is not already provided for in the acts referred to therein. [Am. 165]

(a)

by the operators responsible for consignments of the categories of animals and goods referred to in Article 45(1) in order to give prior notification to the competent authorities of the border control post of the arrival of those consignments;

(b)

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

(a)

all official controls required by Article 47(1) have been performed;

(b)

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

(c)

a decision on the consignment has been taken in accordance with Article 53 and recorded on the CHED. [Am. 170]

(a)

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;

(b)

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 rules referred to in Article 1(2).

(a)

the format of the CHED and the instructions for its presentation and use;

(b)

the minimum time requirements for prior notification of consignments by operators as provided for in point (a) of Article 54(2) in order to enable the competent authorities of the border control post to perform official controls in a timely and effective manner.

(a)

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 115 in order to verify compliance with the minimum requirements laid down in Article 62;

(b)

of the date of such a control.

(a)

its contact details and opening hours;

(b)

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

(c)

the categories of animals and goods referred to in Article 45(1) which are included in the scope of its designation;

(d)

the equipment and premises available for performing official controls on each of the categories of animals and goods for which it is designated;

(e)

the volume of the animals and goods handled per calendar year for each of the categories of animals and goods referred to in Article 45(1) for which it is designated.

(a)

withdraw the designation provided for in Article 57(1) for all or for certain categories of animals and goods for which the designation was made;

(b)

remove them from the lists referred to in Article 58(1), for the categories of animals and goods for which the designation is withdrawn.

(a)

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

(b)

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

(a)

a sufficient number of suitably qualified staff;

(b)

premises appropriate for the nature and volume of the categories of animals and goods handled;

(c)

equipment and premises 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;

(d)

arrangements in place to guarantee, as appropriate, access to any other equipment, premise and service necessary to apply the measures taken in accordance with Articles 63, 64 and 65 in cases of suspicion, non-compliant consignments or consignments presenting a risk;

(e)

contingency arrangements to ensure the smooth operation of official controls and the effective application of the measures taken in accordance with Articles 63, 64 and 65 in cases of unforeseeable and unexpected conditions or events;

(f)

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

(g)

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 TRACES system as appropriate;

(h)

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

(i)

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

(a)

destroy the consignment or part thereof, humanely in the case of live animals, in compliance, where appropriate, with the rules referred to in Article 1(2); or [Am. 179]

(b)

re-dispatch the consignment or part thereof outside the Union in accordance with Article 70(1) and (2); or [Am. 180]

(c)

subject the consignment or part thereof to special treatment in accordance with Article 69(1) and (2) or to any other measure necessary to ensure compliance with the rules referred to in Article 1(2), and, where appropriate, destines the consignment for purposes other than those for which it was originally intended. [Am. 181]

(a)

the Commission;

(b)

the competent authorities of the other Member States;

(c)

the customs authorities;

(d)

the competent authorities of the third country of origin;

(e)

the operator responsible for the consignment.

(a)

order that the operator destroy the consignment , humanely in the case of live animals, in compliance, where appropriate, 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; or [Am. 184]

(b)

subject the consignment to special treatment in accordance with Article 69(1) and (2).

(a)

invalidate the official certificates and other documents accompanying consignments which have been subject to measures pursuant to Article 64(3) and (5) and Article 65;

(b)

cooperate in accordance with Title IV 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 64(1).

(a)

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

(b)

in the cases referred to in Article 65, 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.

(a)

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;

(b)

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

(a)

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, to the environment;

(b)

be documented and carried out under the control of the competent authorities;

(c)

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

(a)

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

(b)

the operator responsible for the consignment has first informed the competent authorities of the third country of origin or third country of destination, if different, of the reasons and circumstances for the refusal of the entry into the Union of the consignment of animals or goods concerned;

(c)

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

(d)

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

(a)

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 behaviour;

(b)

the official certificates that must accompany consignments entering the Union;

(c)

a model for such certificates;

(d)

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

(e)

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 of Articles 25 to 32 or equivalent conditions.

(a)

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;

(b)

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 and physical checks laid down in the rules referred to in Article 1(2).

(a)

be responsible for contacts with the Union;

(b)

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

(a)

notify the Commission and the other Member States and operators concerned via the TRACES system , including the measures to be applied , in addition to seeking administrative assistance in accordance with the procedures established in Title IV; [Am. 188]

(b)

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, detain a reasonable number of samples under appropriate storage conditions.

(a)

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

(b)

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

(a)

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 45(1);

(b)

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;

(c)

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

(a)

they shall instruct 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:

‘Product presents a risk — release for free circulation not authorised — Regulation (EU) No …/…. (*17)’;

(b)

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

(c)

Article 64(1), (3), (4) and (5), Articles 65 to 67, Article 69(1) and (2) and Article 70(1) and (2) shall apply.

(a)

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 (48) from a fishing vessel flying a third country flag;

(b)

consignments of unskinned, furred wild game;

(c)

consignments of the categories of goods referred to in point (b) of Article 45(1) which are delivered, with or without storage in a specially approved free or customs warehouse, to vessels leaving the Union and intended for ship supply or consumption by the crew and passengers;

(d)

wood packaging material; [Am. 190]

(e)

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

(f)

animals and goods ordered by distance selling 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;

(g)

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

(h)

consignments of the categories of animals and goods referred to in points (a), (b) and (c) of Article 45(1) originating from, and returning to, the Union following a refusal of entry by a third country;

(i)

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

(j)

consignments of goods referred to in Article 45(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;

(k)

animals and goods exempted from the provisions of Article 45 in accordance with Article 46.

(a)

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

(b)

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

(a)

official controls performed to verify that the following operators comply with the rules referred to in Article 1(2):

(b)

the official controls performed in view of the issuance of official certificates or to supervise the issuance of official attestations;

(c)

official controls performed to verify that the conditions are met:

(d)

official controls performed by the competent authorities at the border control posts or at the control points referred to in point (a) of Article 51(1).

(a)

the official controls referred to in point (a) of that paragraph shall not include official controls performed to verify compliance with temporary restrictions, requirements or other disease control measures adopted by the competent authorities in accordance with Article 55(1), Article 56, Articles 61 and 62, Articles 64 and 65, Article 68(1) and Article 69, and rules adopted pursuant to Article 55(2), Article 63, Article 67 and Article 68(2) of Regulation (EU) No …/…. (*22) and Article 16 of Regulation (EU) No …/…. (*23);

(aa)

the official controls referred to in point (a) of that paragraph shall not include controls performed at the level of primary production as defined in Article 3(17) of Regulation (EC) No 178/2002, including on farm processing. That includes controls to verify compliance with statutory management requirements in the area of public health, animal health, plant health, and animal welfare in accordance with Article 93 of Regulation (EU) No 1306/2013; [Ams 192, 343, 314 and 316]

(b)

the official controls referred to in point (a) and (b) of that paragraph shall not include official controls performed to verify compliance with the rules referred to in Article 1(2)(j) and (k).

(a)

the salaries of the staff, including support staff, involved in the performance insofar as they correspond to the actual costs of official controls, in accordance with point (b) of Article 79(1) , excluding their social security, pension and insurance costs;

(b)

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

(c)

the cost of consumables, services and tools;

(d)

the cost of training of 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;

(e)

the cost of travel of the staff for the performance of the official controls referred to in point (a), and associated subsistence costs, calculated in accordance with Article 79(2) ;

(f)

the cost of sampling and of laboratory analysis, testing and diagnosis.