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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

Border control posts shall be located in the immediate vicinity of the point of entry into the Union and either in a place which is designated by the customs authorities in accordance with Article 135(1) and (2) of Regulation (EU) No 952/2013 or in a free zone.

The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the cases where and conditions under which a border control post may be situated at a distance other than in the immediate vicinity of the point of entry into the Union in cases of specific geographical constraints.

Border control posts shall have:

(a) a sufficient number of suitably qualified staff;

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

(c) 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;

(d) 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;

(e) 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;

(f) 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;

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

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

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

The Commission may, by means of implementing acts, lay down detailed rules on the requirements under paragraph 3 of this Article to take into account specific features and logistic needs related to the performance of official controls and to the application of the measures taken in accordance with Article 66(3) and (6) and Article 67 in relation to the different categories of animals and goods referred to in Article 47(1). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the cases and conditions under which border control posts designated for the imports of unprocessed logs and sawn and chipped wood may be exempted from one or more of the obligations referred to in paragraph 3 of this Article to take into account the needs of competent authorities in charge of official controls operating under specific geographical constraints, while ensuring the proper performance of the controls.

Section III Action in the event of suspicion of Non-compliance and of Non-compliance of animals and goods entering the union

Article 65

Suspicion of non-compliance and intensified official controls

In the event of suspicion of non-compliance of consignments of the categories of animals and goods referred to in Articles 44(1) and 47(1) with the rules referred to in Article 1(2), the competent authorities shall perform official controls in order to confirm or to eliminate that suspicion.

Consignments of animals and goods which are not declared by operators to consist of the categories of animals and goods referred to in Article 47(1), shall be subject to official controls by the competent authorities where there is reason to believe that such categories of animals or goods are present in the consignment.

The competent authorities shall place the consignments referred to in paragraphs 1 and 2 under official detention pending the outcome of the official controls provided for in those paragraphs.

Where appropriate, those consignments shall be isolated or quarantined and animals shall be sheltered, fed, watered and as necessary treated, pending the outcome of the official controls.

Where the competent authorities have reasons to suspect fraudulent or deceptive practices by an operator responsible for the consignment or the official controls give grounds to believe that the rules referred to in Article 1(2) have been seriously or repeatedly infringed, they shall, where appropriate, and in addition to the measures provided for in Article 66(3), intensify as appropriate official controls on consignments with the same origin or use.

The competent authorities shall notify the Commission and the Member States through the IMSOC of their decision to perform intensified official controls, as provided for in paragraph 4 of this Article, indicating the reasons for their decision.

The Commission shall, by means of implementing acts, lay down rules on the procedures for the coordinated performance by competent authorities of the intensified official controls referred to in paragraphs 4 and 5 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 66

Measures to be taken in cases of non-compliant consignments entering the Union

The competent authorities shall place under official detention any consignment of animals or goods entering the Union which does not comply with the rules referred to in Article 1(2) and shall refuse its entry into the Union.

The competent authorities shall isolate or quarantine, as appropriate, any such consignment and the animals belonging to it shall be kept, cared for or treated under appropriate conditions pending any further decision. If possible, the competent authorities shall also take into account the interest of providing special care in respect of certain types of goods.

The Commission shall, by means of implementing acts, lay down rules on the practical arrangements for the isolation and quarantine provided for in the second subparagraph of paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

The competent authority shall, as regards the consignment referred to in paragraph 1 order, without delay, the operator responsible for the consignment to:

(a) destroy the consignment;

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

(c) 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.

Any action referred to in points (a), (b) and (c) of the first subparagraph shall be performed in compliance with the rules referred to in Article 1(2), including in particular, as regards consignments of live animals, those intended to spare animals any avoidable pain, distress or suffering.

When the consignment consists of plants, plant products or other objects, points (a), (b) and (c) of the first subparagraph shall be applied either to the consignment or to lots thereof.

Before ordering the operator to take action in accordance with (a), (b) and (c) of the first subparagraph, the competent authority shall hear the operator concerned, unless immediate action is necessary in order to respond to a risk to human, animal or plant health, animal welfare or, as regards the GMOs and plant protection products, also to the environment.

Where the competent authority orders the operator to take one or more of the actions laid down in point (a), (b) or (c) of the first subparagraph of paragraph 3, that competent authority may exceptionally authorise the action to be taken in respect of a part of the consignment only, provided that the partial destruction, re-dispatch, special treatment, or other measure:

(a) is such as to ensure compliance;

(b) 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

The competent authorities shall immediately notify any decision to refuse entry of a consignment as provided for in paragraph 1 of this Article, and any order issued in accordance with paragraphs 3 and 6 of this Article and with Article 67 to:

(a) the Commission;

(b) the competent authorities of the other Member States;

(d) the competent authorities of the third country of origin; and

(e) the operator responsible for the consignment.

That notification shall be performed via the IMSOC.

5a. Plants, plant products or other objects subject to the measures referred to in Article 1(2), point (g), which enter the Union as part of passengers’ personal luggage or through postal services intended for personal consumption or use, shall be exempted from the notification obligation set out in paragraph 5 of this Article, if the non-compliance concerns the absence of the phytosanitary certificate or other official attestation as referred to in Article 99(1) of Regulation (EU) 2016/2031.

The competent authorities shall keep a record of those cases of non-compliance and shall, on an annual basis, provide the Commission and the competent authorities of the other Member States with a report containing a summary of those records.

That report shall be submitted via the IMSOC.

If a consignment of the categories of animals or goods referred to in Article 47(1) is not presented for the official controls referred to therein, or is not presented in accordance with the requirements laid down in Articles 50(1) and (3), 56(1), (3) and (4), or with the rules adopted under Article 48, Article 49(4), Article 51, Article 53(1) and Article 58, the competent authorities shall order that such consignment be retained or recalled, and placed under official detention without delay.

Paragraphs 1, 3 and 5 of this Article shall apply to such consignments.

The measures referred to in this Article shall be applied at the expense of the operator responsible for the consignment.

Article 67

Measures to be taken on animals or goods entering the Union from third countries presenting a risk

Where official controls indicate that a consignment of animals or goods presents a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, such consignment shall be isolated or quarantined and the animals belonging to it shall be kept, cared for or treated under appropriate conditions pending any further decision.

The competent authorities shall retain the consignment concerned under official detention and shall, without delay, order the operator responsible for that consignment to:

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

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

The measures referred to in this Article shall be applied at the expense of the operator responsible for the consignment.

Article 68

Follow-up of decisions taken in relation to non-compliant consignments entering the Union from third countries

The competent authorities shall:

(a) 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

(b) 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).

The competent authorities in the Member State where the official controls were performed shall supervise the application of the measures ordered in accordance with Article 66(3) and (6) and Article 67 to ensure that the consignment does not give rise to adverse effects on human, animal or plant health, animal welfare, or the environment, during or pending the application of those measures.

Where appropriate, such application shall be completed under the supervision of the competent authorities of another Member State.

Article 69

Failure by the operator to apply the measures ordered by the competent authorities

The operator responsible for the consignment shall carry out all the measures ordered by the competent authorities in accordance with Article 66(3) and (6) and Article 67 without delay and, at the latest, within 60 days from the day on which the competent authorities notified the operator concerned of their decision in accordance with Article 66(5). The competent authorities may specify a shorter period than the period of 60 days.

If, after the expiry of the period referred to in paragraph 1, no action has been taken by the operator concerned, the competent authorities shall order:

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

(b) 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.

The competent authorities may extend the period referred to in paragraphs 1 and 2 of this Article for the time necessary to obtain the results of the second expert opinion referred to in Article 35, provided that this is without adverse effects to human, animal and plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment.

The measures referred to in this Article shall be applied at the expense of the operator responsible for the consignment.

Article 70

Consistency of application of Articles 66, 67 and 68

The Commission shall, by means of implementing acts, lay down rules to ensure consistency across all border control posts referred to in Article 59(1), and control points referred to in point (a) of Article 53(1), of decisions and measures taken and orders issued by the competent authorities in accordance with Articles 66, 67 and 68 which are to be followed by the competent authorities when responding to common or recurring situations of non-compliance or risk. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 71

Special treatment of consignments

The special treatment of consignments provided for in point (c) of Article 66(3) and point (b) of Article 67 may, as appropriate, include:

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

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

The special treatment provided for in paragraph 1 shall:

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

(b) 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

The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the requirements and the conditions in accordance with which the special treatment provided for in paragraph 1 of this Article is to take place.

In the absence of rules adopted by delegated acts, such special treatment shall take place in accordance with national law.

Article 72

Re-dispatch of consignments

The competent authorities shall allow the re-dispatch of consignments subject to compliance with the following conditions:

(a) the destination has been agreed with the operator responsible for the consignment;

(b) 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;

(c) 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

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

The conditions set out in points (b) and (c) of paragraph 1 of this Article shall not apply to consignments of the categories of goods referred to in point (c) of Article 47(1).

Section IV Approval of the pre-export controls

Article 73

Approval of pre-export controls performed by third countries

The Commission may, by means of implementing acts, approve, upon request of a third country, specific pre-export controls that that third country carries out on consignments of animals and goods prior to export to the Union with a view to verifying that the exported consignments satisfy the requirements of the rules referred to in Article 1(2). Such approval shall only apply to consignments originating in the third country concerned and may be granted for one or more categories of animals or goods. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

The approval provided for in paragraph 1 shall specify:

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

(b) the official certificates that must accompany consignments entering the Union;

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

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

The approval provided for in paragraph 1 of this Article may only be granted to a third country if the evidence available and, where appropriate, a Commission control performed in accordance with Article 120, demonstrate that the system of official controls in that third country is able to ensure that:

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

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

The competent authorities or a delegated body specified in the approval shall:

(a) be responsible for contacts with the Union; and

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

The Commission shall, by means of implementing acts, lay down detailed rules and criteria for approving pre-export controls performed by third countries in accordance with paragraph 1 of this Article and for official controls performed by the competent authorities of the Member States on animals and goods subject to the approval referred in that paragraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 74

Non-compliance with, and withdrawal of, the approval of pre-export controls performed by third countries

When official controls on consignments of categories of animal and goods in respect of which specific pre-export controls have been approved in accordance with Article 73(1) reveal serious and recurrent non-compliance with the rules referred to in Article 1(2), Member States shall immediately:

(a) 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

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

The Commission may, by means of implementing acts, withdraw the approval provided for in Article 73(1) where, following the official controls referred to in paragraph 1 of this Article, there are indications that the requirements laid down in Article 73(3) and (4) are no longer being met. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Section V Cooperation between authorities in relation to consignments from third countries

Article 75

Cooperation between authorities in relation to consignments entering the Union from third countries

Competent authorities, customs authorities and other authorities of the Member States dealing with animals and goods entering the Union shall cooperate closely to ensure that the official controls on consignments of animals and goods entering the Union are performed in accordance with the requirements of this Regulation.

For that purpose, competent authorities, customs authorities and other authorities shall:

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

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

The Commission shall, by means of implementing acts, lay down rules on uniform cooperation arrangements that competent authorities, customs authorities and other authorities referred to in paragraph 1 are required to put in place to ensure:

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

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

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

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

Article 76

Cooperation between authorities in relation to consignments not subject to specific controls at borders

Paragraphs 2, 3, and 4 of this Article shall apply in the case of consignments of animals and goods other than those subject to controls at entry into the Union as required by Article 47(1) of this Regulation and for which a customs declaration for release for free circulation has been made in accordance with point 12 of Article 5 of Regulation (EU) No 952/2013 and Articles 158 to 202 of that Regulation.

Customs authorities shall suspend release for free circulation when they have reason to believe that the consignment may present a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, and immediately notify the competent authorities of such suspension.

A consignment whose release for free circulation has been suspended pursuant to paragraph 2 shall be released if, within three working days of the suspension of release, the competent authorities have not requested customs authorities to continue the suspension or have informed customs authorities that no risk is present.

Where the competent authorities consider that a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, is present;

(a) they shall request the customs authorities not to release the consignment for free circulation and to include the following statement on the commercial invoice accompanying the consignment and on any other relevant accompanying document or the relevant electronic equivalents: ‘Product presents a risk — release for free circulation not authorised — Regulation (EU) 2017/625 ’;

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

(c) 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.

In the case of consignments of animals and goods other than those subject to controls at entry into the Union as required by Article 47(1) and for which no customs declaration for release for free circulation has been made, customs authorities, where they have reason to believe that the consignment may present a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, shall transmit all relevant information to the customs authorities in the Member States of final destination.

Section VI Specific measures

Article 77

Rules for specific official controls and for measures to be taken following the performance of such controls

The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning rules for the performance of specific official controls and on measures in cases of non-compliance, to account for the specificities of the following categories of animals and goods or the arrangements for, and means of, their transport:

(a) consignments of fresh fishery products directly landed in ports designated by Member States in accordance with Article 5(1) of Council Regulation (EC) No 1005/2008 ([^E0016]) from a fishing vessel flying a third country flag;

(b) consignments of unskinned, furred wild game;

(c) consignments of the categories of goods referred to in point (b) of Article 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;

(d) wood packaging material;

(e) feed accompanying animals and intended for the feeding of those animals;

(f) 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;

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

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

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

(j) consignments of goods referred to in Article 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;

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

The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the conditions for monitoring the transport and arrival of consignments of certain animals and goods, from the border control post of arrival to the establishment at the place of destination in the Union, to the border control post at the place of destination or to the border control post of exit.

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

(a) model official certificates and rules for the issuance of such certificates; and

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

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

CHAPTER VI Financing of official controls and of other official activities

Article 78

General rules

Member States shall ensure that adequate financial resources are available to provide the staff and other resources necessary for the competent authorities to perform official controls and other official activities.

This Chapter also applies in the case of delegation of certain official control tasks and other official activities in accordance with Articles 28 and 31.

Article 79

Mandatory fees or charges

The competent authorities shall collect fees or charges for the official controls performed in relation to the activities referred to in Chapter II of Annex IV and on animals and goods referred to in points (a), (b) and (c) of Article 47(1), at border control posts or at control points referred to in point (a) of Article 53(1), either;

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

(b) at the amounts provided for in Annex IV.

The competent authorities shall collect fees or charges to recover the costs they incur in relation to:

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

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

(c) official controls which were not originally planned, and which;
(i) have become necessary following the detection of a case of non-compliance by the same operator, during an official control performed in accordance with this Regulation; and
(ii) are performed to assess the extent and the impact of the case of non-compliance or to verify that the non-compliance has been remedied.

Notwithstanding paragraphs 1 and 2, Member States may, in relation to the activities referred to in Chapter II of Annex IV, on an objective and non-discriminatory basis, reduce the amount of the fees or charges, taking into account:

(a) the interests of operators with a low throughput;

(b) the traditional methods used for production, processing and distribution;

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

Member States may decide that fees and charges calculated in accordance with point (b) of Article 82(1) shall not be collected below the amount at which, taking into account the cost of collection and the overall income expected from the fees and charges, the collection of that fee or charge would be uneconomical.

This Article shall not apply to official controls performed to verify compliance with the rules referred to in points (i) and (j) of Article 1(2).

Article 80

Other fees or charges

Member States may collect fees or charges to cover the costs of official controls and other official activities other than those fees or charges referred to in Article 79, unless prohibited by the legislative provisions applicable in the areas governed by the rules referred to in Article 1(2).

Article 81

Costs

The fees or charges to be collected in accordance with point (a) of Article 79(1) and with Article 79(2) shall be determined on the basis of the following costs, insofar as these result from the official controls concerned:

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

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

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

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

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

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

Article 82

Calculation of fees or charges

Fees or charges collected in accordance with point (a) of Article 79(1) and with Article 79(2) shall be established in accordance with one of the following methods of calculation or a combination of them:

(a) 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

(b) 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.

Travel costs as referred to in point (f) of Article 81 shall be considered for the calculation of the fees or charges referred to in point (a) of Article 79(1) and in Article 79(2) in a manner that does not discriminate between operators on the basis of the distance of their premises from the location of the competent authorities.

Where fees or charges are calculated in accordance with point (a) of paragraph 1, the fees or charges collected by competent authorities shall not exceed the overall costs incurred for the official controls performed over the period of time referred to therein.

Where fees or charges are calculated in accordance with point (b) of paragraph 1, they shall not exceed the actual cost of the official control performed.

Article 83

Collection and application of fees or charges

An operator shall only be charged with a fee or charge for an official control and for another official activity performed on the basis of a complaint if that control leads to the confirmation of non-compliance.

Fees or charges collected in accordance with Articles 79 and 80 shall not be directly or indirectly refunded, unless unduly collected.

Member States may decide that fees or charges shall be collected by authorities other than the competent authorities or by delegated bodies.

Article 84

Payment of fees or charges

The competent authorities shall ensure that the operators receive, upon request, proof of payment of fees or charges in the event that the operators do not otherwise have access to such proof.

Fees or charges collected in accordance with Article 79(1) shall be paid by the operator responsible for the consignment or its representative.

Article 85

Transparency

Member States shall ensure a high level of transparency on:

(a) the fees or charges provided for in point (a) of Article 79(1), Article 79(2) and Article 80, namely on:
(i) the method and data used to establish these fees or charges;
(ii) the amount of the fees or charges, applied to each category of operators and for each category of official controls or other official activities;
(iii) the breakdown of the costs, as referred to in Article 81;

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

Each competent authority shall make available to the public the information referred to in paragraph 1 of this Article for each reference period and the costs to the competent authority for which a fee or charge is due in accordance with point (a) of Article 79(1), Article 79(2) and Article 80.

Member States shall consult relevant stakeholders on the general methods used to calculate the fees or charges provided for in point (a) of Article 79(1), Article 79(2) and Article 80.

CHAPTER VII Official certification

Article 86

General requirements concerning official certification

Official certification shall result in the issuance of:

(a) official certificates; or

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

Where the competent authorities delegate certain tasks related to the issuance of official certificates or official attestations, or to the official supervision referred to in Article 91(1), such delegation shall comply with Articles 28 to 33.

Article 87

Official certificates

Articles 88, 89 and 90 shall apply:

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

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

Article 88

Signature and issuance of official certificates

Official certificates shall be issued by the competent authorities.

Competent authorities shall designate the certifying officers who are authorised to sign official certificates and shall ensure that these officers:

(a) 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

(b) 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.

Official certificates shall be signed by the certifying officer and issued on one of the following grounds:

(a) direct knowledge by the certifying officer of up-to-date facts and data relevant for the certification that is obtained through:
(i) an official control; or
(ii) the acquisition of another official certificate issued by the competent authorities;

(b) 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;

(c) 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.

Official certificates shall be signed by the certifying officer and issued only on the basis of point (a) of paragraph 3 of this Article when rules referred to in Article 1(2) so require.

Article 89

Guarantees of reliability for official certificates

Official certificates shall:

(a) bear a unique code;

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

(c) 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;

(d) be authentic and accurate;

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

(f) 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.

The competent authorities shall take all appropriate measures to prevent the issuance of false or misleading official certificates or the abuse of official certificates.

Article 90

Implementing powers concerning official certificates

The Commission may, by means of implementing acts, lay down rules for the uniform application of Articles 88 and 89 concerning:

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

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

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

(d) rules for the production of certified copies of official certificates;

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

(f) rules for the issuance of electronic certificates and for the use of electronic signatures.

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

Article 91

Official attestations

When this Regulation or the rules referred to in Article 1(2) require the issuance of official attestations by the operators under the official supervision of the competent authorities, or by the competent authorities themselves, paragraphs 2, 3 and 4 of this Article shall apply.

Official attestations shall:

(a) be authentic and accurate;

(b) 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

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

Competent authorities shall ensure that the staff performing official controls to supervise the issuance of official attestations or, where the official attestations are issued by the competent authorities, the staff involved in the issuance of those official attestations:

(a) 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

(b) have received appropriate training on:
(i) the rules with which compliance is certified by the official attestations and on the technical assessment of compliance with those rules;
(ii) the relevant rules laid down in this Regulation.

Competent authorities shall perform regular official controls to verify that:

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

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

TITLE III REFERENCE LABORATORIES AND REFERENCE CENTRES

Article 92

Decision to establish a European Union reference laboratory

In the areas governed by the rules referred to in Article 1(2), a European Union reference laboratory shall be established where the effectiveness of official controls and other official activities also depends on the quality, uniformity and reliability of:

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

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

A European Union reference laboratory shall be established where there is a recognised need to promote uniform practices in relation to the development or use of the methods referred to in point (a) of paragraph 1.

The Commission shall review regularly the mandate and operation of the European Union reference laboratories.

The Commission shall supplement this Regulation by adopting the decision to establish a European Union reference laboratory by means of a delegated act in accordance with Article 144.

Article 93

Designation of European Union reference laboratories

The Commission shall, by means of implementing acts, designate European Union reference laboratories in the cases where a decision has been taken to establish such a laboratory in accordance with Article 92.

The designations provided for in paragraph 1 shall:

(a) follow a public selection process; and

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

European Union reference laboratories shall:

(a) 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:
(i) shall include all the methods of laboratory analysis, test or diagnosis required to be used by the laboratory when it operates as a European Union reference laboratory;
(ii) may comprise one or more methods of laboratory analysis, test or diagnosis or groups of methods;
(iii) may be defined in a flexible manner, so as to allow the scope of the accreditation to include modified versions of the methods used by the European Union reference 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, prior to the use of those modified or new methods, by the national accreditation body of the Member State where the European Union reference laboratory is located;

(b) 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;

(c) 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;

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

(e) 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;

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

(g) where relevant, be equipped to comply with relevant biosecurity standards.

By way of derogation from point (a) of paragraph 3 of this Article, for the area governed by the rules referred to in point (g) of Article 1(2), the Commission may designate official laboratories, designated as such by the competent authorities on the basis of a derogation adopted pursuant to Article 41, as European Union reference laboratories irrespective of whether they fulfil the conditions provided for in point (a) of paragraph 3 of this Article.

By way of derogation from paragraphs 1 and 2 of this Article, the laboratories referred to in the first paragraph of Article 32 of Regulation (EC) No 1829/2003 and the first paragraph of the Article 21 of Regulation (EC) No 1831/2003 shall be the European Union reference laboratories having the responsibilities and performing the tasks referred to in Article 94 of this Regulation in the areas respectively of:

(a) GMOs and genetically modified food and feed; and

(b) feed additives.

The confidentiality obligations of staff, referred to in Article 8, shall apply mutatis mutandis to staff of the European Union reference laboratories.

Article 94

Responsibilities and tasks of European Union reference laboratories

European Union reference laboratories shall contribute to the improvement and harmonisation of methods of analysis, test or diagnosis to be used by official laboratories designated in accordance with Article 37(1) and of the analytical, testing and diagnostic data generated by them.

European Union reference laboratories designated in accordance with Article 93(1) shall be responsible for the following tasks insofar as they are included in the reference laboratories’ annual or multiannual work programmes that have been established in conformity with the objectives and priorities of the relevant work programmes adopted by the Commission in accordance with Article 36 of Regulation (EU) No 652/2014:

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

(b) providing reference materials to national reference laboratories;

(c) 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;

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

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

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

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

(h) 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);

(i) 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;

(j) 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;

(k) where relevant for their area of competence, establishing and maintaining:
(i) reference collections of pests of plants and/or reference strains of pathogenic agents;
(ii) reference collections of materials intended to come into contact with food used to calibrate analytical equipment and provide samples thereof to national reference laboratories;
(iii) up-to-date lists of available reference substances and reagents and of manufacturers and suppliers of such substances and reagents; and

(l) 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.

As regards point (i) of point (k), the European Union reference laboratory may establish and maintain those reference collections and reference strains by contractual outsourcing to other official laboratories and to scientific organisations.

European Union reference laboratories shall publish the list of the national reference laboratories designated by the Member States in accordance with Article 100(1).

Article 95

Designation of European Union reference centres for animal welfare

The Commission shall, by means of implementing acts, designate European Union reference centres for animal welfare that shall support the activities of the Commission and of the Member States in relation to the application of the rules referred to in point (f) of Article 1(2).

The designations provided for in paragraph 1 shall:

(a) follow a public selection process; and

(b) be limited in time or reviewed regularly.

European Union reference centres for animal welfare shall:

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

(b) 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;

(c) 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;

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

(e) 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.

Article 96

Responsibilities and tasks of European Union reference centres for animal welfare

The European Union reference centres for animal welfare shall be responsible for the following supporting tasks insofar as they are included in the reference centres’ annual or multiannual work programmes that have been established in conformity with the objectives and priorities of the relevant work programmes adopted by the Commission in accordance with Article 36 of Regulation (EU) No 652/2014:

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

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

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

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

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

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

Article 97

Designation of European Union reference centres for the authenticity and integrity of the agri-food chain

The Commission may, by means of implementing acts, designate European Union reference centres that shall support the activities of the Commission and of the Member States to prevent, detect and combat violations of the rules referred to in Article 1(2) perpetrated through fraudulent or deceptive practices.

The designations provided for in paragraph 1 shall:

(a) follow a public selection process; and

(b) be limited in time or reviewed regularly.

European Union reference centres for the authenticity and integrity of the agri-food chain shall:

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

(b) 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;

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

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

(e) 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.

Article 98

Responsibilities and tasks of European Union reference centres for the authenticity and integrity of the agri-food chain

The European Union reference centres for the authenticity and integrity of the agri-food chain shall be responsible for the following supporting tasks insofar as they are included in the reference centres’ annual or multiannual work programmes that have been established in conformity with the objectives and priorities of the relevant work programmes adopted by the Commission in accordance with Article 36 of Regulation (EU) No 652/2014:

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

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

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

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

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

Article 99

Obligations of the Commission

The Commission shall publish and update, whenever necessary, the list of:

(a) European Union reference laboratories provided for in Article 93;

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

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

The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the establishment of requirements, responsibilities and tasks for the European Union reference laboratories, the European Union reference centres for animal welfare and European Union reference centres for the authenticity and integrity of the agri-food chain in addition to those laid down in Article 93(3), Article 94, Article 95(3), Article 96, Article 97(3) and Article 98. Such delegated acts shall be limited to situations of new or emerging risks, new or emerging animal diseases or pests of plants or where new legal requirements so warrant.

European Union reference laboratories and European Union reference centres shall be subject to Commission controls to verify compliance with the requirements of Article 93(3), Article 94, and Articles 95(3) and 97(3).

If the Commission controls referred to in paragraph 3 of this Article show non-compliance with the requirements laid down in Article 93(3), Article 94, and Articles 95(3) and 97(3), the Commission shall, after having received the comments of the European Union reference laboratory or European Union reference centre:

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

(b) take any other appropriate measure.

Article 100

Designation of national reference laboratories

Member States shall designate one or more national reference laboratories for each European Union reference laboratory designated in accordance with Article 93(1).

Member States may designate a national reference laboratory also in the cases where there is no corresponding European Union reference laboratory.

A Member State may designate a laboratory situated in another Member State or in a third country that is a Contracting Party to the Agreement on the European Economic Area.

A single laboratory may be designated as a national reference laboratory for more than one Member State.

The requirements provided for in point (e) of Article 37(4), Article 37(5), Article 39 and Article 42(1), points (a) and (b) of Article 42(2) and Article 42(3) shall apply to national reference laboratories.

By way of derogation from point (e) of Article 37(4), for the area governed by the rules referred to in point (g) of Article 1(2), competent authorities may designate official laboratories, designated as such by the competent authorities on the basis of a derogation adopted under Article 41, as national reference laboratories irrespective of whether they fulfil the condition provided for in point (e) of Article 37(4).

National reference laboratories shall:

(a) 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;

(b) 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;

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

(d) 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;

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

(f) where relevant, be equipped to comply with relevant biosecurity standards.

Member States shall:

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

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

Member States that have more than one national reference laboratory for a European Union reference laboratory shall ensure that such laboratories work closely together, so as to ensure efficient coordination between them, with other national laboratories and with the European Union reference laboratory.

The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the establishment of requirements for national reference laboratories in addition to those laid down in paragraphs 2 and 3 of this Article. Such delegated acts shall be limited to ensuring coherence with any additional requirements adopted in accordance with Article 99(2).

Article 101

Responsibilities and tasks of national reference laboratories

National reference laboratories shall, in their area of competence:

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

(b) 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;

(c) 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;

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

(e) 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;

(f) 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;

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

(h) 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.

The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the establishment of responsibilities and tasks for national reference laboratories in addition to those provided for in paragraph 1 of this Article. Such delegated acts shall be limited to ensuring coherence with any additional responsibilities and tasks adopted in accordance with Article 99(2).

TITLE IV ADMINISTRATIVE ASSISTANCE AND COOPERATION

Article 102

General rules

The competent authorities in the Member States concerned shall provide each other with administrative assistance in accordance with Articles 104 to 107, in order to ensure the correct application of the rules referred to in Article 1(2) in cases which have relevance in more than one Member State.

Administrative assistance shall include, where appropriate, and, by agreement between the competent authorities concerned, participation by the competent authorities of a Member State in on-the-spot official controls that the competent authorities of another Member State perform.

This Title shall be without prejudice to national law:

(a) 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

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

Member States shall take measures to facilitate the transmission, from other law enforcement authorities, public prosecutors and judicial authorities, to the competent authorities, of information on possible non-compliance with the rules referred to in Article 1(2) which is relevant for the application of this Title and which may constitute:

(a) 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

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

All communications between competent authorities in accordance with Articles 104 to 107 shall be in writing, on paper or in electronic form.

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