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Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (Text with EEA relevance)

Type Regulation
Publication 2017-04-07
Last updated 2025-01-05
State In force
Department Council of the European Union, European Parliament
Source EUR-Lex
articles 167
Reform history JSON API
3.

The Commission may, by means of implementing acts, lay down rules on uniform practical arrangements for the performance of the official controls referred to in paragraph 1, taking into account the need to ensure a minimum level of official controls to prevent practices that infringe those rules regarding uniform minimum frequency of such official controls where a minimum level of official control is necessary to respond to recognised uniform hazards and risks of:

  • (a) 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;
  • (b) 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.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

4.

For the purpose of Article 30, the delegation of certain official control tasks, referred to in this Article, to one or more natural persons shall be allowed.

Article 24
Specific rules on official controls and for action taken by the competent authorities in relation to plant protection products
1.

Official controls to verify compliance with the rules referred to in point (h) of Article 1(2) of this Regulation shall include official controls on active substances and safeners, synergists, co-formulants and adjuvants as referred to in Article 2(2) and (3) of Regulation (EC) No 1107/2009.

2.

For the purpose of establishing the frequency of risk based official controls referred to in paragraph 1, competent authorities shall take into account also the following:

  • (a) 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 ([^E0010]);
  • (b) 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 ([^E0011]); and
  • (c) 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 ([^E0012]).
3.

The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation by laying down rules for the performance of official controls referred to in paragraph 1 of this Article. Those delegated acts shall lay down rules on:

  • (a) 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
  • (b) 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).
4.

The Commission may, by means of implementing acts, lay down detailed rules on uniform practical arrangements for the performance of official controls on the products referred to in paragraph 1 regarding:

  • (a) 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;
  • (b) the collection of information, monitoring and reporting on suspected poisonings from plant protection products;
  • (c) the collection of information, and the monitoring of and reporting on non-authorised plant protection products including illegal trade of plant protection products.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

5.

For the purpose of Article 30, the delegation of certain official control tasks, referred to in this Article, to one or more natural persons shall be allowed.

Article 25
Specific rules on official controls and other official activities for organic production and labelling of organic products

The Commission may, by means of implementing acts, lay down rules on uniform practical arrangements for the performance of official controls to verify compliance with the rules referred to in point (i) of Article 1(2), regarding:

  • (a) specific requirements and additional content to that provided for in Article 110 to prepare the relevant parts of the MANCP provided for in Article 109(1), and specific additional content to the report provided for in Article 113;
  • (b) specific responsibilities and tasks for the European Union reference centres in addition to those provided for in Article 98;
  • (c) 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;
  • (d) the methods to be used for sampling and for laboratory analyses and tests, excluding any rules involving the setting of thresholds.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 26
Specific rules on official controls and other official activities performed by the competent authorities in relation to protected designations of origin, protected geographical indications and traditional specialities guaranteed
1.

By way of derogation from Article 31(3), in relation to the rules referred in point (j) of Article 1(2), where competent authorities have delegated the decisions concerning the authorisation to use the registered name of a product, they may also delegate the application of the following measures:

  • (a) ordering that certain activities of the operator be subject to systematic or increased official controls;
  • (b) ordering the operator to increase the frequency of own controls;
  • (c) ordering the alteration of label in order to comply with the product specifications and the rules referred in point (j) of Article 1(2).
2.

The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation by laying down rules for the performance of official controls to verify compliance with the rules referred to in point (j) of Article 1(2). Those delegated acts shall lay down rules on:

  • (a) requirements, methods and techniques referred to in Articles 12 and 14 for official controls performed to verify compliance with product specifications and labelling requirements;
  • (b) 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;
  • (c) 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).
3.

The Commission may, by means of implementing acts, lay down rules on uniform practical arrangements for the performance of the official controls to verify compliance with the rules referred to in point (j) of Article 1(2) regarding:

  • (a) 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
  • (b) specific reporting obligations of the delegated bodies.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

4.

For the purpose of Article 30, the delegation of certain official control tasks, referred to in this Article, to one or more natural persons shall be allowed.

Article 27
Specific rules on official controls and for action taken by the competent authorities in cases of newly identified risks in relation to food and feed
1.

The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation by laying down rules for the performance of official controls on certain categories of food or feed to verify compliance with the rules referred to in points (a) to (e) of Article 1(2) and for action to be taken by the competent authorities following such official controls. Those delegated acts shall address newly identified risks which may arise through food or feed to human or animal health or, in relation to GMOs and plant protection products, also to the environment, or any such risks emerging from new patterns of production or consumption of food or feed, and which cannot be effectively addressed in the absence of such common rules. Those delegated acts shall lay down rules on:

  • (a) 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
  • (b) 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).
2.

The Commission may, by means of implementing acts, lay down rules on uniform practical arrangements on official controls performed on certain categories of food or feed to verify compliance with the rules referred to in points (a) to (e) of Article 1(2) to address newly identified risks which may arise through food or feed to human or animal health or, in relation to GMOs and plant protection products, also to the environment, or any such risks emerging from new patterns of production or consumption of food or feed, and which cannot be effectively addressed in the absence of such common rules regarding uniform minimum frequency of such official controls, where a minimum level of official control is necessary 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. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

3.

On duly justified imperative grounds of urgency relating to cases of serious risks to human or animal health or to the environment, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 145(3).

CHAPTER III Delegation of certain tasks of the competent authorities

Article 28
Delegation by the competent authorities of certain official control tasks
1.

Competent authorities may delegate certain official control tasks to one or more delegated bodies or natural persons in accordance with the conditions provided for in Articles 29 and 30 respectively. The competent authority shall ensure that the delegated body or natural person, to which such tasks have been delegated, have the powers needed to effectively perform these tasks.

2.

Where a competent authority or a Member State decides to delegate certain official control tasks for the verification of compliance with the rules referred to in point (i) of Article 1(2) to one or more delegated bodies, it shall attribute a code number to each delegated body, and shall designate relevant authorities responsible for their approval and supervision.

Article 29
Conditions for delegating certain official control tasks to delegated bodies

The delegation of certain official control tasks to a delegated body referred to in Article 28(1) shall be in writing and shall comply with the following conditions:

  • (a) the delegation contains a precise description of those official control tasks that the delegated body may perform, and the conditions under which it may perform those tasks;
  • (b) the delegated body:
  • (i) has the expertise, equipment and infrastructure required to perform those official control tasks delegated to it;
  • (ii) has a sufficient number of suitably qualified and experienced staff;
  • (iii) is impartial and free from any conflict of interest and in particular is not in a situation which may, directly or indirectly, affect the impartiality of its professional conduct as regards the performance of those official control tasks delegated to it;
  • (iv) works and is accredited in accordance with standards relevant to the delegated tasks in question, including standard EN ISO/IEC 17020 ‘Requirements for the operation of various types of bodies performing inspection’;
  • (v) has sufficient powers to perform the official control tasks delegated to it; and
  • (c) there are arrangements in place ensuring efficient and effective coordination between the delegating competent authorities and the delegated body.
Article 30
Conditions for delegating certain official control tasks to natural persons

Competent authorities may delegate certain official control tasks to one or more natural persons, where the rules provided for in Articles 18 to 27 so allow. Such delegation shall be in writing and shall comply with the following conditions:

  • (a) the delegation contains a precise description of those official control tasks that the natural persons may perform and the conditions under which the natural persons may perform those tasks;
  • (b) the natural persons:
  • (i) have the expertise, equipment and infrastructure required to perform those official control tasks delegated to them;
  • (ii) are suitably qualified and experienced;
  • (iii) act impartially and are free from any conflict of interest as regards the exercise of those official control tasks delegated to them; and
  • (c) there are arrangements in place ensuring efficient and effective coordination between the delegating competent authorities and the natural persons.
Article 31
1.

The competent authorities may delegate certain tasks related to other official activities to one or more delegated bodies subject to compliance with the following conditions:

  • (a) the rules referred to in Article 1(2) do not prohibit such delegation; and
  • (b) the conditions laid down in Article 29 are fulfilled with the exception of that laid down in point (b)(iv).
2.

The competent authorities may delegate certain tasks related to other official activities to one or more natural persons subject to compliance with the following conditions:

  • (a) the rules referred to in Article 1(2) allow such delegation; and
  • (b) the conditions laid down in Article 30, applied mutatis mutandis, are fulfilled.
3.

Competent authorities shall not delegate to a delegated body or to a natural person the decision concerning the tasks provided for in point (b) of Article 138(1) and in Article 138(2) and (3).

Article 32
Obligations of the delegated bodies and natural persons

Delegated bodies or natural persons to which certain official control tasks have been delegated in accordance with Article 28(1), or certain tasks related to other official activities have been delegated in accordance with Article 31, shall:

  • (a) communicate the outcome of the official controls and other official activities performed by them to the delegating competent authorities on a regular basis and whenever those competent authorities so request;
  • (b) immediately inform the delegating competent authorities whenever the outcome of the official controls indicate non-compliance or point to the likelihood of non-compliance, unless specific arrangements established between the competent authority and the delegated body or the natural person concerned provides otherwise; and
  • (c) give competent authorities access to their premises and facilities and cooperate and provide assistance.
Article 33
Obligations of the delegating competent authorities

Competent authorities that have delegated certain official control tasks to delegated bodies or natural persons in accordance with Article 28(1), or certain tasks related to other official activities to delegated bodies or natural persons in accordance with Article 31, shall:

  • (a) organise audits or inspections of such bodies or persons, as necessary and avoiding duplication, taking into account any accreditation referred to in point (b)(iv) of Article 29;
  • (b) fully or partly withdraw the delegation without delay where:
  • (i) there is evidence that such a delegated body or natural person is failing to properly perform the tasks delegated to it;
  • (ii) the delegated body or the natural person fails to take appropriate and timely action to remedy the shortcomings identified; or
  • (iii) the independence or impartiality of the delegated body or natural person has been shown to be compromised. This point shall be without prejudice to the competence of the competent authorities to withdraw the delegation for reasons other than those referred to in this Regulation.

CHAPTER IV Sampling, analyses, tests and diagnoses

Article 34
Methods used for sampling, analyses, tests and diagnoses
1.

Methods used for sampling and for laboratory analyses, tests and diagnoses during official controls and other official activities shall comply with Union rules establishing those methods or the performance criteria for those methods.

2.

In the absence of the Union rules as referred to in paragraph 1, and in the context of official controls and other official activities, official laboratories shall use one of the following methods according to the suitability for their specific analytical, testing and diagnostic needs:

  • (a) 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;
  • (b) 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.
3.

Where laboratory analyses, tests or diagnoses are urgently needed and none of the methods referred to in paragraphs 1 and 2 of this Article exists, the relevant national reference laboratory or, if no such national reference laboratory exists, any other laboratory designated in accordance with Article 37(1) may use methods other than those referred to in paragraphs 1 and 2 of this Article until the validation of an appropriate method in accordance with internationally accepted scientific protocols.

4.

Wherever possible, methods used for laboratory analyses shall be characterised by the relevant criteria set out in Annex III.

5.

Samples shall be taken, handled and labelled in such a way as to ensure their legal, scientific and technical validity.

6.

The Commission may, by means of implementing acts, lay down rules on:

  • (a) the methods to be used for sampling and for laboratory analyses, tests and diagnoses;
  • (b) performance criteria, analysis, test or diagnosis parameters, measurement uncertainty and procedures for the validation of those methods;
  • (c) the interpretation of analytical, testing and diagnostic results.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 35
Second expert opinion
1.

The competent authorities shall ensure that operators, whose animals or goods are subject to sampling, analysis, test or diagnosis in the context of official controls, have the right to a second expert opinion, at the operator’s own expense.

The right to a second expert opinion shall entitle the operator to request a documentary review of the sampling, analysis, test or diagnosis by another recognised and appropriately qualified expert.

2.

Where relevant, appropriate and technically feasible, having regard in particular to the prevalence and distribution of the hazard in the animals or goods, to the perishability of the samples or the goods and to the amount of available substrate, the competent authorities shall:

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

This paragraph shall not apply when assessing the presence of quarantine pests in plants, plant products or other objects for the purpose of verifying compliance with the rules referred to in point (g) of Article 1(2).

3.

Member States may decide that, where there is a dispute between the competent authorities and the operators that is based on the second expert opinion referred to in paragraph 1, the operators may request, at their own expense, the documentary review of the initial analysis, test or diagnosis and, where appropriate, another analysis, test or diagnosis by another official laboratory.

4.

The application by the operator for a second expert opinion under paragraph 1 of this Article shall not affect the obligation of competent authorities to take prompt action to eliminate or contain the risks to human, animal and plant health, or to animal welfare or, as regards GMOs and plant protection products, also to the environment, in accordance with this Regulation and with the rules referred to in Article 1(2).

Article 36
Sampling of animals and goods offered for sale by means of distance communication
1.

In the case of animals and goods offered for sale by means of distance communication, samples ordered from operators by the competent authorities without identifying themselves may be used for the purposes of an official control.

2.

Competent authorities, once they are in possession of the samples, shall take all steps to ensure that the operators from whom these samples have been ordered in accordance with paragraph 1:

  • (a) 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
  • (b) 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).
3.

Paragraphs 1 and 2 shall apply to delegated bodies and natural persons to which certain official controls tasks have been delegated.

Article 37
Designation of official laboratories
1.

The competent authorities shall designate official laboratories to carry out the laboratory analyses, tests and diagnoses on samples taken during official controls and other official activities, in the Member State in whose territory those competent authorities operate or in another Member State or a third country that is a Contracting Party to the Agreement on the European Economic Area.

2.

Competent authorities may designate as an official laboratory a laboratory located in another Member State or third country that is a Contracting Party to the Agreement on the European Economic Area, subject to compliance with the following conditions:

  • (a) 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
  • (b) that laboratory is already designated as an official laboratory by the competent authorities of the Member State on whose territory it is located.
3.

The designation of an official laboratory shall be in writing and shall include a detailed description of:

  • (a) the tasks that the laboratory carries out as an official laboratory;
  • (b) the conditions under which it carries out the tasks referred to in point (a); and
  • (c) the arrangements necessary to ensure efficient and effective coordination and collaboration between the laboratory and the competent authorities.
4.

The competent authorities may only designate as an official laboratory a laboratory which:

  • (a) has the expertise, equipment and infrastructure required to carry out analyses or tests or diagnoses on samples;
  • (b) has a sufficient number of suitably qualified, trained and experienced staff;
  • (c) 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;
  • (d) 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
  • (e) 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.
5.

The scope of the accreditation of an official laboratory as referred to in point (e) of paragraph 4:

  • (a) 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;
  • (b) may comprise one or more methods of laboratory analysis, test or diagnosis or groups of methods;
  • (c) may be defined in a flexible manner, so as to allow the 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.
6.

Where no official laboratory designated in the Union or in a third country that is a Contracting Party to the Agreement on the European Economic Area in accordance with paragraph 1 has the expertise, equipment, infrastructure and staff necessary to perform new or particularly uncommon laboratory analyses, tests or diagnoses, the competent authorities may request a laboratory or diagnostic centre which does not comply with one or more of the requirements set out in paragraphs 3 and 4 to carry out those analyses, tests and diagnoses.

Article 38
Obligations of official laboratories
1.

Where the results of an analysis, test or diagnosis carried out on samples taken during official controls or other official activities indicate a risk to human, animal or plant health, or, as regards GMOs and plant protection products, also to the environment, or point to the likelihood of non-compliance, official laboratories shall inform immediately the competent authorities which designated them for that analysis, test or diagnosis and, where relevant, delegated bodies or natural persons to which tasks have been delegated. However, specific arrangements between the competent authorities, delegated bodies or natural persons to which tasks have been delegated and the official laboratories may specify that this information is not required to be provided immediately.

2.

Upon request by the European Union reference laboratory or national reference laboratory, official laboratories shall take part in inter-laboratory comparative tests or proficiency tests that are organised for the analyses, tests or diagnoses they perform as official laboratories.

3.

Official laboratories shall, upon request of the competent authorities, make available to the public the names of the methods used for analyses, tests or diagnoses performed in the context of official controls and other official activities.

4.

Official laboratories shall indicate, at the request of the competent authorities, together with the results, the method used for each analysis, testing or diagnosis, performed in the context of official controls and other official activities.

Article 39
Audits of official laboratories
1.

The competent authorities shall organise audits of the official laboratories they have designated in accordance with Article 37(1) on a regular basis and any time they consider that an audit is necessary, unless they find such audits to be redundant considering the accreditation assessment referred to in point (e) of Article 37(4).

2.

The competent authorities shall immediately withdraw the designation of an official laboratory, either completely or for certain tasks, where it fails to take appropriate and timely remedial action following the results of an audit provided for in paragraph 1 which disclose any of the following:

  • (a) it no longer complies with the conditions provided for in Article 37(4) and (5);
  • (b) it does not comply with the obligations provided for in Article 38;
  • (c) it is underperforming at inter-laboratory comparative tests referred to in Article 38(2).
Article 40
Derogations from the condition for the mandatory accreditation for certain official laboratories
1.

By way of derogation from point (e) of Article 37(4), competent authorities may designate the following as official laboratories irrespective of whether they fulfil the condition provided for in that point:

  • (a) laboratories:
  • (i) whose sole activity is the detection of Trichinella in meat;
  • (ii) that only use the methods of detection of Trichinella referred to in Article 6 of Commission Implementing Regulation (EU) 2015/1375 ([^E0013]);
  • (iii) that carry out the detection of Trichinella under the supervision of the competent authorities or of an official laboratory designated in accordance with Article 37(1) and accredited in accordance with the standard EN ISO/IEC 17025 for the use of the methods referred to in point (ii) of this point; and
  • (iv) that participate regularly and have satisfactory performance in the inter-laboratory comparative tests or proficiency tests organised by the national reference laboratories for the methods they use for the detection of Trichinella;
  • (b) laboratories which only carry out analyses, tests or diagnoses in the context of other official activities, provided that they:
  • (i) only use the methods of laboratory analysis, test and diagnosis referred to in Article 34(1) and point (a) or (b) of Article 34(2);
  • (ii) carry out the analyses, tests or diagnoses under the supervision of the competent authorities or of the national reference laboratories in relation to the methods they use;
  • (iii) participate regularly and have satisfactory performance in the inter-laboratory comparative tests or proficiency tests organised by the national reference laboratories in relation to the methods they use; and
  • (iv) have a quality assurance system in place to ensure sound and reliable results from the methods for laboratory analysis, test and diagnosis used.
2.

Where the methods used by the laboratories referred to in point (b) of paragraph 1 of this Article require confirmation of the result of the laboratory analysis, test or diagnosis, the confirmatory laboratory analysis, test or diagnosis shall be carried out by an official laboratory which complies with the requirements set out in point (e) of Article 37(4).

3.

The official laboratories designated in accordance with paragraph 1 shall be located in the Member States in whose territory the competent authorities which have designated them are located.

Article 41
Powers to adopt derogations from the condition for the mandatory accreditation of all the methods of laboratory analysis, test and diagnosis used by official laboratories

The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the cases where, and the conditions under which, competent authorities may designate as official laboratories, in accordance with Article 37(1), laboratories which do not fulfil the conditions referred to in point (e) of Article 37(4) in relation to all the methods they use for official controls or other official activities, provided that such laboratories comply with the following conditions:

  • (a) they operate and are accredited in accordance with the standard EN ISO/IEC 17025 for the use of one or more methods which are similar to and representative of the other methods they use; and
  • (b) they make regular and significant use of the methods for which they have obtained the accreditation referred to in point (a) of this Article; except, as regards the area governed by the rules referred to in point (g) of Article 1(2), where a validated method for the detection of the particular pests of plants referred to in Article 34(1) and (2) does not exist.
Article 42
Temporary derogations from the conditions of the mandatory accreditation for official laboratories
1.

By way of derogation from point (a) of Article 37(5), the competent authorities may temporarily designate an existing official laboratory as an official laboratory in accordance with Article 37(1) for the use of a method of laboratory analysis, test or diagnosis for which it has not obtained the accreditation referred to in point (e) of Article 37(4):

  • (a) when the use of that method is newly required by Union rules;
  • (b) when changes to a method in use require a new accreditation or an extension of the scope of the accreditation obtained by the official laboratory; or
  • (c) in cases where the need for the use of the method results from an emergency situation or an emerging risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment.
2.

The temporary designation referred to in paragraph 1 shall be subject to the following conditions:

  • (a) the official laboratory is already accredited in accordance with the standard EN ISO/IEC 17025 for the use of a method which is similar to the one not included within the scope of its accreditation;
  • (b) a quality assurance system is in place in the official laboratory to ensure sound and reliable results by using a method which is not included within the scope of the existing accreditation;
  • (c) the analyses, tests or diagnoses are carried out under the supervision of the competent authorities or the national reference laboratory for that method.
3.

The temporary designation provided for in paragraph 1 shall not exceed a period of one year. It may be renewed once for a further period of one year.

4.

The official laboratories designated in accordance with paragraph 1 shall be located in the Member States in whose territory the competent authorities which have designated them are located.

CHAPTER V Official controls on animals and goods entering the Union

Article 43
Official controls on animals and goods entering the Union

Official controls on animals and goods entering the Union shall be organised on a risk basis. In relation to animals and goods referred to in Articles 47 and 48, such official controls shall be performed in accordance with Articles 47 to 64.

Section I Animals and goods other than those subject to official controls at border control posts under section II

Article 44
Official controls on animals and goods other than those subject to official controls at border control posts under Section II
1.

To ascertain compliance with the rules referred to in Article 1(2), the competent authorities shall perform official controls regularly, on a risk basis and with appropriate frequency, on animals and goods entering the Union and to which Articles 47 and 48 do not apply.

2.

On animals and goods referred to in paragraph 1 the appropriate frequency of the official controls shall be determined, taking into account:

  • (a) 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;
  • (b) 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;
  • (c) the history of compliance with the requirements established by the rules referred to in Article 1(2) applicable to the animals or goods concerned:
  • (i) of the third country and establishment of origin or place of production, as appropriate;
  • (ii) of the exporter;
  • (iii) of the operator responsible for the consignment;
  • (d) the controls that have already been performed on the animals and goods concerned; and
  • (e) 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.
3.

The official controls provided for in paragraph 1 shall be performed at an appropriate place within the customs territory of the Union, including:

  • (a) the point of entry into the Union;
  • (b) a border control post;
  • (c) the point of release for free circulation in the Union;
  • (d) the warehouses and the premises of the operator responsible for the consignment;
  • (e) the place of destination.
4.

Notwithstanding paragraphs 1 and 3, the competent authorities at border control posts and other points of entry into the Union shall perform official controls on the following whenever they have reason to believe that their entry into the Union may pose a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment:

  • (a) means of transport, including where empty; and
  • (b) packaging, including pallets.
5.

The competent authorities may also perform official controls on goods that are placed under one of the customs procedures defined in point (16)(a), (b) and (c) of Article 5 of Regulation (EU) No 952/2013 and in a temporary storage defined in point (17) of Article 5 of that Regulation.

Article 45
Types of official controls on animals and goods other than those subject to official controls at border control posts under Section II
1.

Where official controls are performed in accordance with Article 44(1), they shall:

  • (a) always include a documentary check; and
  • (b) 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.
2.

The competent authorities shall carry out the physical checks referred to in point (b) of paragraph 1 under appropriate conditions allowing investigations to be conducted properly.

3.

Where the documentary checks, identity checks or physical checks referred to in paragraph 1 of this Article show that animals and goods do not comply with the rules referred to in Article 1(2), Article 66(1), (3) and (5), Articles 67, 68, and 69, Article 71(1) and (2), Article 72(1) and (2), Articles 137 and 138 shall apply.

4.

The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the cases where and the conditions under which competent authorities may request operators to notify the arrival of certain goods entering the Union.

Article 46
Samples taken on animals and goods other than those subject to official controls at border control posts under Section II
1.

Where samples on animals and goods are taken, the competent authorities shall, without prejudice to Articles 34 to 42:

  • (a) inform the operators concerned and, where appropriate, the customs authorities; and
  • (b) 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.
2.

The Commission shall, by means of implementing acts:

  • (a) establish the procedures necessary to ensure the traceability of the animals or goods referred to in point (b) of paragraph 1; and
  • (b) identify the documents that must accompany the animals or goods referred to in paragraph 1 when samples have been taken by the competent authorities.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Section II Official controls at border control posts on animals and goods

Article 47
Animals and goods subject to official controls at border control posts
1.

To ascertain compliance with the rules referred to in Article 1(2), the competent authorities shall perform official controls, at the border control post of first arrival into the Union, on each consignment of the following categories of animals and goods entering the Union:

  • (a) animals;
  • (b) 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’);
  • (c) 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;
  • (d) 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;
  • (e) animals and goods which are subject to an emergency measure provided for in acts adopted in accordance with Article 53 of Regulation (EC) No 178/2002, Article 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;
  • (f) 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.
2.

The Commission shall, by means of implementing acts:

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

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

3.

The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning amendments to the categories of consignments referred to in paragraph 1 of this Article, to include composite products, hay and straw, and other products strictly limited to products presenting a newly identified or a significantly increased risk to human, animal or plant health or, as regards GMOs and plant protection products, also to the environment.

4.

Unless otherwise provided by the acts establishing the measures or conditions referred to in points (d), (e) and (f) of paragraph 1, this Article shall also apply to consignments of the categories of animals and goods referred to in points (a), (b) and (c) of paragraph 1 when they are of a non-commercial nature.

5.

Operators responsible for the consignment shall ensure that animals and goods of the categories referred to in paragraph 1 are presented for official controls at the border control post referred to therein.

Article 48
Animals and goods exempted from official controls at border control posts

The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning rules establishing the cases where, and the conditions under which, the following categories of animals and goods are exempted from Article 47, and when such exemption is justified:

  • (a) goods sent as trade samples or as display items for exhibitions, which are not intended to be placed on the market;
  • (b) animals and goods intended for scientific purposes;
  • (c) goods on board means of transport operating internationally which are not unloaded and are intended for consumption by the crew and passengers;
  • (d) goods which form part of passengers personal luggage and are intended for personal consumption or use;
  • (e) small consignments of goods sent to natural persons which are not intended to be placed on the market;
  • (f) pet animals as defined in point (11) of Article 4 of Regulation (EU) 2016/429;
  • (g) goods which have undergone specific treatment and do not exceed quantities to be established in those delegated acts;
  • (h) categories of animals or goods posing a low risk or no specific risk and for which controls at border control posts are therefore not necessary.
Article 49
Official controls at border control posts
1.

To verify compliance with the applicable requirements laid down in the rules referred to in Article 1(2), the competent authorities shall perform official controls on the consignments of the categories of animals and goods referred to in Article 47(1) upon arrival of the consignment at the border control post. Those official controls shall include documentary checks, identity checks and physical checks.

2.

Physical checks shall be performed where those checks concern:

  • (a) 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;
  • (b) 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;
  • (c) plants, plant products and other objects, by an official plant health officer.
3.

The competent authorities at border control posts shall systematically perform official controls on consignments of animals being transported and on means of transport to verify compliance with the animal welfare requirements laid down in the rules referred to in Article 1(2). Competent authorities shall put in place arrangements to give priority to official controls on animals being transported and to reduce delays on such controls.

4.

The Commission may, by means of implementing acts, lay down rules on the practical arrangements for presentation of consignments of the categories of animals and goods referred to in Article 47(1), the transport units or sub-entities which can constitute an individual consignment and the maximum number of such transport units or sub-entities in each consignment, taking into account the need to ensure the rapid and efficient handling of the consignments and the official controls to be performed by the competent authorities and, where relevant, international standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

5.

The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning rules establishing specific training requirements for staff referred to in paragraph 2 of this Article for the performance of the physical checks at the border control posts.

Article 50
Certificates and documents accompanying consignments and split consignments
1.

The original official certificates or documents, or electronic equivalents, which are required by the rules referred to in Article 1(2) to accompany consignments of the categories of animals and goods referred in Article 47(1) shall be presented to, and kept by, the competent authorities of the border control post unless otherwise provided for in the rules referred to in Article 1(2).

2.

The competent authorities of the border control post shall issue the operator responsible for the consignment with an authenticated paper or electronic copy of the official certificates or documents referred to in paragraph 1 or, if the consignment is split, with individually authenticated paper or electronic copies of such certificates or documents.

3.

Consignments shall not be split until official controls have been performed and the Common Health Entry Document (CHED) referred to in Article 56 has been finalised in accordance with Article 56(5) and Article 57.

4.

The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning rules establishing the cases where, and the conditions under which, the CHED is required to accompany consignments of the categories of animals and goods referred to in Article 47(1) to the place of destination.

Article 51
Specific rules for official controls at border control posts
1.

The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning rules to establish:

  • (a) the cases where, and the conditions under which, the competent authorities of a border control post may authorise the onward transportation of consignments of the categories of animals and goods referred to in Article 47(1) to the place of final destination pending the availability of the results of physical checks, where such checks are required;
  • (b) the time limits and 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’);
  • (c) 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;
  • (d) 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;
  • (e) 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).
2.

The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning rules to establish the cases where, and the conditions under which, derogations from the rules on documentary checks shall apply as regards transhipped consignments and transit of consignments of the goods referred to in point (c) of Article 47(1).

Article 52
Details of documentary checks, identity checks and physical checks

For the purposes of ensuring the uniform implementation of Articles 49, 50 and 51, the Commission shall, by means of implementing acts, lay down detailed rules on the operations to be carried out during and after the documentary checks, identity checks and physical checks referred to in those Articles to ensure the efficient performance of those official controls. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 53
Official controls not performed at border control posts
1.

The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning rules establishing the cases where and the conditions under which:

  • (a) 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);
  • (b) 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;
  • (c) 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;
  • (d) 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:
  • (i) consignments referred to in Article 65(2);
  • (ii) passengers’ personal luggage;
  • (iii) goods ordered by sales through distance contracts, including by telephone or via the internet;
  • (iv) pet animals which meet the conditions laid down in Article 5 of Regulation (EU) No 576/2013 of the European Parliament and of the Council ([^E0014]);
  • (e) 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.
2.

Point (b) of Article 56(3), point (a) of Article 57(2), Article 59(1), points (a) and (d) of Article 60(1) and Articles 62 and 63 shall also apply to the control points referred to in point (a) of paragraph 1 of this Article.

Article 54
Frequency of documentary checks, identity checks and physical checks
1.

All consignments of the categories of animals and goods referred to in Article 47(1) shall be subject to documentary checks.

2.

Identity checks and physical checks shall be performed on consignments of the categories of animals and goods referred to in Article 47(1) at a frequency dependent on the risk posed by each animal, good or category of animals or goods to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment.

3.

The Commission shall, by means of implementing acts, lay down rules for the uniform application of the appropriate frequency rate referred to in paragraph 2. Those rules shall ensure that those frequencies are higher than a zero frequency and shall establish:

  • (a) 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:
  • (i) information collected by the Commission in accordance with Article 125(1);
  • (ii) the outcome of controls performed by Commission experts in accordance with Article 120(1);
  • (iii) operators’ past record as regards compliance with the rules referred to in Article 1(2);
  • (iv) data and information collected via the information management system for official controls (IMSOC) referred to in Article 131;
  • (v) available scientific assessments; and
  • (vi) any other information regarding the risk associated to the categories of animals and goods;
  • (b) 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;
  • (c) 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.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

4.

The Commission shall, by means of implementing acts, lay down rules on:

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

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 55
Decisions on consignments
1.

A decision shall be taken by the competent authorities on each consignment of the categories of animals and goods referred to in Article 47(1) following the performance of official controls including documentary and, where necessary, identity checks and physical checks, indicating whether the consignment is in compliance with the rules referred to in Article 1(2) and, where relevant, the applicable customs procedure.

2.

Decisions on consignments shall be taken by:

  • (a) an official veterinarian where they concern animals, products of animal origin, germinal products or animal by-products; or
  • (b) an official plant health officer where they concern plants, plant products and other objects.
3.

By way of derogation from point (a) of paragraph 2, competent authorities may decide that the decision on consignments of fishery products, live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption, be taken by appropriately trained staff who have been specifically designated by competent authorities for that purpose.

Article 56
Use of the Common Health Entry Document (CHED) by the operator and by the competent authorities
1.

For each consignment of the categories of animals and goods referred to in Article 47(1) the operator responsible for the consignment shall complete the relevant part of the CHED, providing the information necessary for the immediate and complete identification of the consignment and its destination.

2.

References in this Regulation to the CHED include a reference to its electronic equivalent.

3.

The CHED shall be used by:

  • (a) 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
  • (b) the competent authorities of the border control post, in order to:
  • (i) record the outcome of the official controls performed and any decisions taken on that basis, including the decision to reject a consignment;
  • (ii) communicate the information referred to in point (i) through the IMSOC.
4.

Operators responsible for the consignment shall give prior notification in accordance with point (a) of paragraph 3 by completing and submitting the relevant part of the CHED into the IMSOC for transmission to the competent authorities of the border control post prior to the physical arrival of the consignment into the Union.

5.

The competent authorities of the border control post shall finalise the CHED as soon as:

  • (a) all official controls required by Article 49(1) have been performed;
  • (b) the results from physical checks, where such checks are required, are available; and
  • (c) a decision on the consignment has been taken in accordance with Article 55 and recorded on the CHED.
Article 57
Use of the CHED by customs authorities
1.

The placing and handling of consignments of the categories of animals and goods referred to in Article 47(1) under a customs procedure, including the entry or handling in customs warehouses or free zones, shall be subject to the presentation of the CHED by the operator responsible for the consignment to the custom authorities, without prejudice to the exemptions referred to in Article 48 and the rules referred to in Articles 53 and 54. At this stage, the CHED shall have been duly finalised in the IMSOC by the competent authorities of the border control post.

2.

Customs authorities shall:

  • (a) not allow the placing of the consignment under a customs procedure different from the one indicated by the competent authorities of the border control post; and
  • (b) 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).
3.

Where a customs declaration is made for a consignment of the categories of animals or goods referred to in Article 47(1) and the CHED is not presented, the customs authorities shall detain the consignment and immediately notify the competent authorities of the border control post. The competent authorities shall take the necessary measures in accordance with Article 66(6).

Article 58
Format, time requirements and specific rules for the use of the CHED

The Commission shall, by means of implementing acts, lay down rules on:

  • (a) the format of the CHED and the instructions for its presentation and use, taking into account relevant international standards; and
  • (b) the minimum time requirements for prior notification of consignments by operators responsible for the consignment as provided for in point (a) of Article 56(3) in order to enable the competent authorities of the border control post to perform official controls in a timely and effective manner.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 59
Designation of border control posts
1.

Member States shall designate border control posts for the purpose of performing official controls on one or more of the categories of animals and goods referred to in Article 47(1).

2.

Member States shall notify the Commission before designating a border control post. That notification shall include all the information necessary for the Commission to verify that the proposed border control post complies with the minimum requirements laid down in Article 64.

3.

Within three months of receiving the notification referred to in paragraph 2, the Commission shall inform the Member State:

  • (a) whether the designation of the proposed border control post is dependent upon the favourable outcome of a control performed by Commission experts in accordance with Article 116 in order to verify compliance with the minimum requirements laid down in Article 64; and
  • (b) of the date of such a control, which is not to be later than six months from the notification.
4.

In cases where the Commission has informed a Member State, in accordance with paragraph 3, that a control is not necessary, the Member State may proceed with the designation.

5.

The Member State shall delay designating the border control post until the favourable outcome of the control has been communicated to it by the Commission. The Commission shall communicate the outcome of its control as referred to in point (a) of paragraph 3 at the latest within three months from the date of that control.

Article 60
Listing of border control posts
1.

Each Member State shall make available on the internet up-to-date lists of border control posts on its territory, providing the following information for each border control post:

  • (a) its contact details;
  • (b) its opening hours;
  • (c) its exact location and whether it is a port, airport, rail or road entry point; and
  • (d) the categories of animals and goods referred to in Article 47(1) which are included in the scope of its designation.
2.

The Commission shall, by means of implementing acts, lay down rules on the format, categories, abbreviations for designations and other information to be used by Member States in the lists of border control posts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 61
Withdrawal of approvals for, and re-designation of, existing border control entities
1.

The approval of border inspection posts in accordance with Article 6 of Directive 97/78/EC and Article 6 of Directive 91/496/EEC, the designation of points of entry in accordance with Article 5 of Regulation (EC) No 669/2009 and with Article 13c(4) of Directive 2000/29/EC and the designation of first points of introduction in accordance with Article 5 of Commission Regulation (EU) No 284/2011 ([^E0015]) shall be withdrawn.

2.

Member States may re-designate border inspection posts, designated points of entry, points of entry and first points of introduction referred to in paragraph 1 of this Article as border control posts in accordance with Article 59(1) provided that the minimum requirements referred to in Article 64 are complied with.

3.

Article 59(2), (3) and (5) shall not apply to the re-designation referred to in paragraph 2 of this Article.

Article 62
Withdrawal of the designation of border control posts
1.

Where border control posts cease to comply with the requirements referred to in Article 64, the Member States shall:

  • (a) 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
  • (b) 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.
2.

Member States shall inform the Commission and the other Member States of the withdrawal of the designation of a border control post as provided for in paragraph 1 and of the reasons for such withdrawal.

3.

The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the cases where, and the procedures by which, border control posts for which the designation has only been partially withdrawn in accordance with point (a) of paragraph 1 of this Article may be re-designated by way of derogation from Article 59.

4.

This Article shall be without prejudice to Member States’ competence to decide on the withdrawal of designation of border control posts for reasons other than those referred to in this Regulation.

Article 63
Suspension of the designation of border control posts
1.

A Member State shall suspend the designation of a border control post and order its activities to be stopped, for all or for certain categories of animals and goods for which the designation was made, in cases where such activities may result in a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment. In the case of a serious risk, the suspension shall be with immediate effect.

2.

Member States shall immediately inform the Commission and the other Member States of any suspension of the designation of a border control post and the reasons for such a suspension.

3.

Member States shall indicate the suspension of the designation of a border control post in the lists referred to in Article 60(1).

4.

Member States shall remove the suspension provided for in paragraph 1 as soon as:

  • (a) the competent authorities are satisfied that the risk referred to in paragraph 1 no longer exists; and
  • (b) they have communicated to the Commission and to the other Member States the information on the basis of which the suspension is removed.
5.

This Article shall be without prejudice to Member States’ competence to decide on the suspension of designation of border control posts for reasons other than those referred to in this Regulation.

Article 64
Minimum requirements for border control posts

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