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

the financing of official controls;

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

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

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

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

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

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

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

animal health requirements;

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

welfare requirements for animals;

protective measures against pests of plants;

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

organic production and labelling of organic products;

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

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

Directive 2010/63/EU of the European Parliament and of the Council ( 1 );

Directive 2001/82/EC of the European Parliament and of the Council ( 2 ).

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

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

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

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

the competent authorities designated in accordance with paragraph 1;

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

the organic control authorities referred to in paragraph 3;

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

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

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

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

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

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

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

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

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

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

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

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

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

the purpose of inspections, investigations or audits;

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

the protection of court proceedings and legal advice.

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

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

identified risks associated with:

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

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

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

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

the rules referred to in Article 1(2);

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

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

to be exported from the Union; or

entering the Union.

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

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

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

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

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

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

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

regularly informed of the level of compliance; and

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

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

their computerised information management systems;

the animals and goods under their control;

their documents and any other relevant information.

their name and legal form; and

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

the experience gained by competent authorities and food and feed business operators when applying the procedures referred to in Article 5 of Regulation (EC) No 852/2004 of the European Parliament and of the Council ( 7 ) and Article 6 of Regulation (EC) No 183/2005 of the European Parliament and of the Council ( 8 );

scientific and technological developments;

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

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

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

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

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

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

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

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

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

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

act independently from the production staff of the slaughterhouse;

have undergone appropriate training to carry out these tasks; and

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

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

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

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

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

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

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

criteria and conditions to determine, by way of derogation from paragraph 6, when production and relaying areas are not to be classified in relation to:

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

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

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

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

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

the conditions for the classification and monitoring of classified production and relaying areas for live bivalve molluscs, echinoderms, tunicates and marine gastropods;

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

results of relevant monitoring activities including those on pesticides residues carried out for the purpose of Article 32(2) of Regulation (EC) No 396/2005 and of Article 8 of Directive 2000/60/EC of the European Parliament and of the Council ( 10 );

information on non-authorised plant protection products, including illegal trade of plant protection product, and results of relevant controls by the authorities referred to in Article 8 of Regulation (EU) No 649/2012 of the European Parliament and of the Council ( 11 ); and

information on poisoning related to plant protection products, including information available in accordance to Article 56 of Regulation (EC) No 1107/2009, and information on emergency health responses made available by the centres referred to in Article 45(1) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council ( 12 ).

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

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

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

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

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

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

ordering the operator to increase the frequency of own controls;

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

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

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

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

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

specific reporting obligations of the delegated bodies.

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

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

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

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

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

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

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

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

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

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

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

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

the interpretation of analytical, testing and diagnostic results.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

laboratories:

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

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

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

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

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

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

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

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

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

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

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

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

the point of entry into the Union;

a border control post;

the point of release for free circulation in the Union;

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

the place of destination.

means of transport, including where empty; and

packaging, including pallets.

always include a documentary check; and

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

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

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

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

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

animals;

products of animal origin, germinal products, animal by-products, hay and straw and foodstuffs containing both products of plant origin and processed products of animal origin (‘composite products’);

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

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

animals and goods which are subject to an emergency measure provided for in acts adopted in accordance with Article 53 of Regulation (EC) No 178/2002, Article 261 of Regulation (EU) 2016/429, or Articles 28(1), 30(1), 40(3), 41(3), 49(1), 53(3) and 54(3) of Regulation (EU) 2016/2031 requiring consignments of those animals or goods, identified by means of their codes from the Combined Nomenclature, to be subject to official controls at their entry into the Union;

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

its contact details;

its opening hours;

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

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

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

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

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

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

a sufficient number of suitably qualified staff;

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

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

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

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

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

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

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

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

destroy the consignment;

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

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

is such as to ensure compliance;

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

does not disrupt official control operations.

the Commission;

the competent authorities of the other Member States;

the customs authorities;

the competent authorities of the third country of origin; and

the operator responsible for the consignment.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

the official certificates that must accompany consignments entering the Union;

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

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

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

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

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

be responsible for contacts with the Union; and

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

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

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

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

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

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

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

‘Product presents a risk — release for free circulation not authorised — Regulation ►C1  (EU) 2017/625 ◄ ’;

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

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

consignments of fresh fishery products directly landed in ports designated by Member States in accordance with Article 5(1) of Council Regulation (EC) No 1005/2008 ( 16 ) from a fishing vessel flying a third country flag;

consignments of unskinned, furred wild game;

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

wood packaging material;

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

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

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

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

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

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

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

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

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

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

at the amounts provided for in Annex IV.

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

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

official controls which were not originally planned, and which;

the interests of operators with a low throughput;

the traditional methods used for production, processing and distribution;

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

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

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

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

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

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

official certificates; or

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

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

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

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

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

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

bear a unique code;

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

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

be authentic and accurate;

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

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

be authentic and accurate;

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

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

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

have received appropriate training on:

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

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

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

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

follow a public selection process; and

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

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

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

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

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

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

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

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

GMOs and genetically modified food and feed; and

feed additives.

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

providing reference materials to national reference laboratories;

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

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

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

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

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

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

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

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

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

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

follow a public selection process; and

be limited in time or reviewed regularly.

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

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

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

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

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

follow a public selection process; and

be limited in time or reviewed regularly.

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

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

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

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

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

European Union reference laboratories provided for in Article 93;

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

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

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

take any other appropriate measure.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

the communication of common and recurrent notifications and responses.

acknowledge receipt of the request without delay;

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

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

acknowledge receipt of the notification without undue delay;

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

where investigations referred to in point (b) are considered necessary, investigate the matter and inform the notifying competent authorities without delay of the results and, where appropriate, of any measures taken.

acknowledge receipt of the notification;

where the notifying competent authority so specifies, indicate what investigations they intend to carry out; and

investigate the matter, take all necessary measures and inform the notifying competent authorities of the nature of the investigations and official controls performed, of the decisions taken and of the reasons for such decisions.

seek an agreed approach with the aim of appropriately addressing the non-compliance, including through joint official controls and investigations performed in accordance with Article 104(3); and

inform the Commission without delay where they are not able to agree on appropriate measures.

notify such information to the competent authorities in other concerned Member States; and

communicate such information to the Commission where it is or may be relevant at Union level.

the competent authorities which have provided the information consent to such communication;

the third country has undertaken to provide the assistance necessary to gather evidence of practices that are or appear to be non-compliant with Union rules or that pose a risk to humans, animals or plants or the environment; and

relevant Union and national rules applicable to the communication of personal data to third countries are complied with.

reports activities that are, or appear to be, non-compliant with the rules referred to in Article 1(2), and such activities have, or might have, ramifications in more than one Member State; or

indicates that the same, or similar, activities that are, or appear to be, non-compliant with the rules referred to in Article 1(2) might be taking place in more than one Member State.

in collaboration with the Member State concerned, send an inspection team to perform an on-the-spot official control;

request, by means of implementing acts, that the competent authorities in the Member State of dispatch and, where appropriate, in other Member States concerned, appropriately intensify official controls and report to it on the measures taken by them;

take any other appropriate measure in accordance with the rules referred to in Article 1(2).

coordinating the preparation of the MANCP across all competent authorities responsible for the official controls;

ensuring that the MANCP is coherent;

collecting the information on the implementation of the MANCP in view of submitting the annual reporting referred to in Article 113 and of its review and update as necessary in accordance with Article 111(2).

the strategic objectives of the MANCP and on how the prioritisation of official controls and allocation of resources reflect these objectives;

the risk categorisation of the official controls;

the designation of competent authorities and their tasks at central, regional and local level, and on resources available to those authorities;

where appropriate, the delegation of tasks to delegated bodies;

the general organisation and management of official controls at national, regional and local level, including official controls in individual establishments;

control systems applied to different sectors and coordination between the different services of competent authorities responsible for official controls in those sectors;

procedures and arrangements in place to ensure compliance with the obligations of the competent authorities provided for in Article 5(1);

the training of staff of the competent authorities;

the documented procedures provided for in Article 12(1);

the general organisation and operation of contingency plans in accordance with the rules referred to in Article 1(2); and

the general organisation of cooperation and mutual assistance between competent authorities in the Member States.

the emergence of new diseases, pests of plants or other risks to human, animal or plant health, animal welfare or, in the case of GMOs and plant protection products, also to the environment;

significant changes to the structure, management or operation of the competent authorities in the Member State;

the outcome of Member States’ official controls;

the outcome of Commission controls performed in the Member State in accordance with Article 116(1);

scientific findings; and

the outcome of official controls performed by the competent authorities of a third country in a Member State.

any amendments made to its MANCP to take account of the factors referred to in Article 111(2);

the outcome of official controls performed in the previous year under its MANCP;

the type and number of cases of non-compliance with the rules referred to in Article 1(2), per area, detected in the previous year by the competent authorities;

the measures taken to ensure the effective operation of its MANCP, including enforcement action and the results of such measures, and

a link to the web page of the competent authority containing the public information on fees or charges referred to in Article 85(2).

the annual reports submitted by the Member States in accordance with Article 113; and

the results of Commission controls performed in accordance with Article 116(1).

the competent authorities to be involved;

the powers and responsibilities of the authorities referred to in point (a); and

channels and procedures for sharing information between competent authorities and other parties concerned as appropriate.

rules for the establishment of the contingency plans provided for in paragraph 1 of this Article to the extent necessary to ensure the consistent and effective use of the general plan for crisis management provided for in Article 55(1) of Regulation (EC) No 178/2002; and

the role of stakeholders in the establishment and operation of those contingency plans.

verify the application of the rules referred to in Article 1(2) and those provided for in this Regulation;

verify the functioning of national control systems in the areas governed by the rules referred to in Article 1(2) and those provided for in this Regulation, and of the competent authorities which operate them;

investigate and collect information:

establish an annual or multiannual control programme for the controls to be performed by its experts in the Member States as provided for in Article 116(1); and

by the end of each year, communicate to the Member States the annual control programme or any update to the multiannual control programme for the following year.

verify the compliance or equivalence of third-country legislation and systems, including official certification and the issuance of official certificates, official labels, official marks and other official attestations, with the requirements laid down in the rules referred to in Article 1(2);

verify the capacity of the third country control system to ensure that consignments of animals and goods exported to the Union comply with relevant requirements established by the rules referred to in Article 1(2) or with requirements recognised to be at least equivalent thereto;

collect information and data to elucidate the causes of recurring or emerging problems in relation to exports of animals and goods from a third country.

the legislation of the third country;

the organisation of the third country’s competent authorities, their powers and independence, the supervision to which they are subject and the authority they have to enforce the applicable legislation effectively;

the training of staff of the competent authority of the third country in the performance of official controls;

the resources including analytical, testing and diagnostic facilities available to competent authorities;

the existence and operation of documented control procedures and control systems based on priorities;

where applicable, the situation regarding animal health, animal welfare, zoonoses and plant health, and procedures for notifying the Commission and relevant international bodies of outbreaks of animal diseases and pests of plants;

the extent and operation of controls performed by the competent authority of the third country on animals, plants and their products arriving from other third countries; and

the assurances which the third country can give regarding compliance with, or equivalence to, the requirements laid down in the rules referred to in Article 1(2).

the necessary information referred to in Article 125(1); and

where appropriate and necessary, the written records on the controls its competent authorities perform.

provide advice on the rules referred to in Article 1(2);

provide information and data available at Union level that may be useful for the control performed by the competent authorities of the third country;

facilitate consistency and uniformity with regard to controls performed by the competent authorities of third countries in different Member States.

any sanitary or phytosanitary rules adopted or proposed within their territory;

risk-assessment procedures and factors taken into consideration for the assessment of risks and for the determination of the appropriate level of sanitary or phytosanitary protection;

any control and inspection procedures and mechanisms, including, where relevant, on animals or goods arriving from other third countries;

official certification mechanisms;

where appropriate, any measures taken following recommendations provided for in the first paragraph of Article 122;

where relevant, results of controls performed on animals and goods intended to be exported to the Union; and

where relevant, information on changes made to the structure and functioning of control systems adopted to meet Union sanitary or phytosanitary requirements or recommendations provided for in the first paragraph of Article 122.

the requirement that certain animals and goods shall only enter the Union from a third country or region of a third country which appears on a list drawn up by the Commission for that purpose;

the requirement that consignments of certain animals and goods from third countries be dispatched from, and obtained or prepared in, establishments which comply with the relevant requirements referred to in paragraph 1 or with requirements recognised to be at least equivalent thereto;

the requirement that consignments of certain animals and goods be accompanied by an official certificate, an official attestation, or by any other evidence that the consignments comply with the relevant requirements referred to in paragraph 1 or with requirements recognised to be at least equivalent thereto, including the results of the analysis performed by an accredited laboratory;

the obligation to provide the evidence referred to in point (c) in accordance with a specific format;

any other requirement necessary to ensure that certain animals and goods offer a level of protection of health and, as regards GMOs, also of the environment, equivalent to that ensured by the requirements referred to in paragraph 1.

the third country’s legislation in the sector concerned;

the structure and organisation of the competent authorities of the third country and its control services, the powers available to them, the guarantees that can be provided with regard to the application and enforcement of the legislation of the third country applicable to the sector concerned, and the reliability of the official certification procedures;

the performance by the competent authorities of the third country of adequate official controls and other activities to assess the presence of hazards for human, animal or plant health, for animal welfare or, in relation to GMOs and plant protection products, also for the environment;

the regularity and rapidity of information supplied by the third country on the presence of hazards for human, animal or plant health, for animal welfare or, in relation to GMOs and plant protection products, also for the environment;

the guarantees given by the third country that:

the findings of controls performed by the Commission in the third country in accordance with Article 120(1);

any other information or data on the capability of the third country to ensure that only animals or goods which provide the same or an equivalent level of protection as that afforded by the relevant requirements referred to in Article 126(1) enter the Union.

the prohibition of entry into the Union of the animals and goods referred to in paragraph 1 originating in or dispatched from the third countries concerned or regions thereof;

the requirement that the animals and goods referred to in paragraph 1 originating in or dispatched from certain third countries or regions thereof be subject, prior to dispatch, to specific treatment or controls;

the requirement that the animals and goods referred to in paragraph 1 originating in or dispatched from certain third countries or regions thereof be subject, upon entry into the Union, to specific treatment or controls;

the requirement that consignments of the animals and goods referred to in paragraph 1 of this Article originating in or dispatched from certain third countries or regions thereof, be accompanied by an official certificate, an official attestation, or by any other evidence that the consignment complies with requirements established by the rules referred to in Article 1(2) or with requirements recognised to be at least equivalent thereto;

the requirement that the evidence referred to in point (d) be provided in accordance with a specific format;

other measures necessary to contain the risk.

the information collected in accordance with Article 125;

any other information that the third countries concerned have provided; and

where necessary, the results of Commission controls provided for in Article 120(1).

a thorough examination of information and data provided by the third country concerned pursuant to Article 125(1); and

where appropriate, the satisfactory outcome of a control performed in accordance with Article 120(1).

the nature and content of the official certificates or attestations that have to accompany the animals or goods;

specific requirements applicable to the entry into the Union of the animals or goods and the official controls to be performed at entry into the Union;

where necessary, procedures for drawing up and amending lists of regions or establishments in the third country concerned from which the entry of animals and goods into the Union is permitted.

this Regulation and the rules referred to in Article 1(2);

control methods and techniques relevant for the official controls and for the other official activities of the competent authorities;

production, processing and marketing methods and techniques.

enable the competent authorities at the border control posts and other competent authorities responsible for performing official controls on those animals or goods to exchange, in real time, data, information and documents concerning those animals and goods and on controls performed on those animals or goods;

enable the competent authorities at the border control posts to share and exchange relevant data, information and documents with customs authorities and other authorities responsible for performing controls on animals or goods entering the Union from third countries, and with operators involved in entry procedures, in accordance with the rules adopted pursuant to Articles 15(4) and 75(2) and with other relevant Union rules; and

support and operate the procedures referred to in point (a) of Article 54(3) and in Article 65(6).

the performance of intensified official controls on animals, goods and operators for an appropriate period;

the official detention of animals and goods and of any unauthorised substances or products as appropriate.

any action necessary to determine the origin and extent of the non-compliance and to establish the operator’s responsibilities; and

appropriate measures to ensure that the operator concerned remedies the non-compliance and prevents further occurrences of such non-compliance.

order or perform treatments on animals;

order the unloading, transfer to another means of transport, holding and care of animals, quarantine periods, the postponement of the slaughter of animals, and, if necessary, order that veterinary assistance be sought;

order treatments on goods, the alteration of labels or corrective information to be provided to consumers;

restrict or prohibit the placing on the market, the movement, the entry into the Union or the export of animals and goods; and prohibit their return to the Member State of dispatch or order their return to the Member State of dispatch;

order the operator to increase the frequency of own controls;

order certain activities of the operator concerned to be subject to increased or systematic official controls;

order the recall, withdrawal, removal and destruction of goods, authorising, where appropriate, the use of the goods for purposes other than those for which they were originally intended;

order the isolation or closure, for an appropriate period of time, of all or part of the business of the operator concerned, or its establishments, holdings or other premises;

order the cessation for an appropriate period of time of all or part of the activities of the operator concerned and, where relevant, of the internet sites it operates or employs;

order the suspension or withdrawal of the registration or approval of the establishment, plant, holding or means of transport concerned, of the authorisation of a transporter or of the certificate of competence of the driver;

order the slaughter or killing of animals provided that this is the most appropriate measure to safeguard human health as well as animal health and welfare.

written notification of their decision concerning the action or measure to be taken in accordance with paragraphs 1 and 2, together with the reasons for that decision; and

information on any right of appeal against such decisions and on the applicable procedure and time limits with respect to such right of appeal.

the temporary suspension of the certifying officer from its duties;

the withdrawal of the authorisation to sign official certificates;

any other measure to prevent a reoccurrence of the offences referred to in Article 89(2).

procedures for the receipt of reports of infringements and their follow-up;

appropriate protection for persons reporting an infringement against retaliation, discrimination or other types of unfair treatment; and

protection of personal data of the person reporting an infringement in accordance with Union and national law.

the prohibition to make available on the market or to transport, move or otherwise handle certain animals or goods concerned by the disruption in the control system;

special conditions for the activities, animals or goods referred to in point (a);

the suspension of the operation of official controls in border control posts or other control points concerned by the disruption in the official control system or the withdrawal of such border control posts or other control points;

other appropriate temporary measures necessary to contain that risk until the disruption in the control system is eliminated.

Article 2 is amended as follows:

Articles 14, 15, 16 and 21, Article 22(2), and Articles 23, 24 and 26 are deleted.

Article 27 is amended as follows:

Article 28 is deleted.

Article 4 is amended as follows:

in Article 229, paragraph (2) is replaced by the following:

Article 281 is deleted.

Article 9 of Directive 89/662/EEC;

Article 10 of Directive 90/425/EEC;

Article 18(1), (3), (4), (5), (6), (7) and (8) of Directive 91/496/EEC;

Article 22(1), (3), (4), (5), (6) and (7) of Directive 97/78/EC.

Article 2, point (6) is replaced by the following:

Article 10 is replaced by the following:

‘Article 10

Official confirmation by the competent authorities of the presence of a Union quarantine pest

Where a competent authority suspects, or has received evidence concerning, the presence of a Union quarantine pest, or a pest subject to measures adopted pursuant to Article 30(1), in a part of the territory of the respective Member State where that pest was previously not known to be present, or in a consignment of plants, plant products or other objects introduced into, intended to be introduced into, or moved within the Union territory, it shall immediately take any measures necessary to confirm on the basis of a diagnosis of an official laboratory as referred to in Article 37 of Regulation ►C1  (EU) 2017/625 ◄ (“to officially confirm”), whether that pest is present or not.

Pending the official confirmation of the presence of that pest, the Member States concerned shall, where applicable, take phytosanitary measures to eliminate the risk of spread of that pest.

The suspicion or evidence referred to in the first paragraph of this Article may be based on any information received pursuant to Articles 14 and 15, or from any other source.’;

in Article 11, the second paragraph is replaced by the following:

‘Notifications under the first paragraph shall be made by the single authority, as referred to in Article 4(2) of Regulation ►C1  (EU) 2017/625 ◄ , of the Member State concerned and through the electronic notification system referred to in Article 103.’;

in Article 25(2), point (a) is replaced by the following:

in Article 41, paragraph 4 is replaced by the following:

Where applicable, that notification shall also be made to the third country from which the plants, plant products or other objects were introduced into the Union territory.’;

in Article 44, paragraph 2 is replaced by the following:

in Article 49(6), the third subparagraph is replaced by the following:

‘Member States shall notify, through the electronic notification system referred to in Article 103 of this Regulation, the Commission and the other Member States of any case where the introduction of a plant, plant product or other object into the Union territory was refused, or its movement within the Union territory prohibited, because the Member State concerned considered that the prohibition referred to in point (c) of the second subparagraph of paragraph 2 of this Article was violated. Where applicable, that notification shall include the measures taken by that Member State on the plants, plant products or other objects concerned pursuant to Article 66(3) of Regulation ►C1  (EU) 2017/625 ◄ .’;

in Article 76, paragraphs 4 and 5 are replaced by the following:

The Commission is empowered to adopt delegated acts, in accordance with Article 105, to supplement this Regulation concerning the conditions for acceptance referred to in the first subparagraph of this paragraph, to ensure the reliability of those certificates.

in Article 77(1), the first subparagraph is replaced by the following:

in Article 91(1), the second subparagraph is replaced by the following:

‘Authorised operators implementing an approved pest risk management plan may be subject to inspections with a reduced frequency, as referred to in point (b) of Article 22(3) of Regulation ►C1  (EU) 2017/625 ◄ .’;

in Article 94(1), the first subparagraph is replaced by the following:

in Article 100, paragraph 5 is replaced by the following:

in Article 101, paragraph 6 is replaced by the following:

in Article 102, paragraph 4 is replaced by the following:

Article 103 is replaced by the following: