02017R0625 — EN — 14.12.2019 — 001.002

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This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

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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) (OJ L 095 7.4.2017, p. 1)

Amended by:

		Official Journal
		No	page	date
►M1	COMMISSION DELEGATED REGULATION (EU) 2019/478 of 14 January 2019	L 82	4	25.3.2019
►M2	COMMISSION DELEGATED REGULATION (EU) 2019/2127 of 10 October 2019	L 321	111	12.12.2019

Corrected by:

►C1	Corrigendum, OJ L 137, 24.5.2017, p.  40 (2017/625)

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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)

TITLE I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

1.  This Regulation lays down rules for:

2.  This Regulation shall apply to the official controls performed for the verification of compliance with the rules, whether established at Union level or by the Member States, to apply Union legislation, in the areas of:

3.  This Regulation shall also apply to official controls performed for the verification of compliance with requirements laid down in the rules referred to in paragraph 2 where those requirements are applicable to animals and goods entering the Union or to be exported from the Union.

4.  This Regulation shall not apply to official controls for the verification of compliance with:

5.  Articles 4, 5, 6, 8, Article 12(2) and (3), Articles 15, 18 to 27, 31 to 34, 37 to 42 and 78, Articles 86 to 108, point (b) of Article 112, Article 130 and Articles 131 to 141 shall also apply to other official activities performed by the competent authorities in accordance with this Regulation or with the rules referred to in paragraph 2 of this Article.

Article 2

Official controls and other official activities

1.  For the purposes of this Regulation, ‘official controls’ means activities performed by the competent authorities, or by the delegated bodies or the natural persons to which certain official control tasks have been delegated in accordance with this Regulation, in order to verify:

2.  For the purposes of this Regulation, ‘other official activities’ means activities, other than official controls, which are performed by the competent authorities, or by the delegated bodies or the natural persons to which certain other official activities have been delegated in accordance with this Regulation, and with the rules referred to in Article 1(2), including activities aimed at verifying the presence of animal diseases or pests of plants, preventing or containing the spread of such animal diseases or pests of plants, eradicating those animal diseases or pests of plants, granting authorisations or approvals, and issuing official certificates or official attestations.

Article 3

Definitions

For the purposes of this Regulation, the following definitions apply:

TITLE II

OFFICIAL CONTROLS AND OTHER OFFICIAL ACTIVITIES IN MEMBER STATES

CHAPTER I

Competent authorities

Article 4

Designation of competent authorities

1.  For each of the areas governed by the rules referred to in Article 1(2), Member States shall designate the competent authority or authorities on which they confer the responsibility to organise or perform official controls and other official activities.

2.  Where, for the same area, a Member State confers the responsibility to organise or perform official controls or other official activities on more than one competent authority, at national, regional or local level, or where the competent authorities designated in accordance with paragraph 1 are allowed by that designation to transfer specific responsibilities for official controls or other official activities to other public authorities, the Member State shall:

3.  Competent authorities responsible for the verification of compliance with the rules referred to in point (i) of Article 1(2) may confer certain responsibilities related to official controls or other official activities to one or more organic control authorities. In such cases, they shall attribute a code number to each of them.

4.  Member States shall ensure that the Commission is informed of the contact details and of any changes regarding:

The information referred to in the first subparagraph shall also be made available by Member States to the public, including on the internet.

Article 5

General obligations concerning the competent authorities and the organic control authorities

1.  The competent authorities and the organic control authorities shall:

2.  Any appointment of an official veterinarian shall be in writing and shall set out the official controls and the other official activities and related tasks for which the appointment has been made. Requirements imposed on staff of competent authorities that are provided for in this Regulation, including the requirement on freedom from any conflict of interest, shall apply to all official veterinarians.

3.  Any appointment of an official plant health officer shall be in writing and shall set out the official controls and the other official activities and related tasks for which the appointment has been made. Requirements imposed on staff of competent authorities that are provided for in this Regulation, including the requirement on freedom from any conflict of interest, shall apply to all official plant health officers.

4.  Staff performing official controls and other official activities shall:

Competent authorities, organic control authorities and delegated bodies shall develop and implement training programmes for the purpose of ensuring that staff performing official controls and other official activities receive the training referred to in points (a), (b) and (c).

5.  When, within the services of a competent authority, more than one unit is competent to perform official controls or other official activities, efficient and effective coordination and cooperation shall be ensured between the different units.

Article 6

Audits of the competent authorities

1.  To ensure their compliance with this Regulation, the competent authorities shall carry out internal audits or have audits carried out on themselves and shall take appropriate measures in the light of the results of those audits.

2.  The audits referred to in paragraph 1 shall be subject to independent scrutiny and carried out in a transparent manner.

Article 7

Right of appeal

The decisions taken by the competent authorities in accordance with Article 55, Article 66(3) and (6), Article 67, point (b) of Article 137(3), and Article 138(1) and (2), concerning natural or legal persons shall be subject to such persons’ right of appeal in accordance with national law.

The right of appeal shall not affect the obligation of competent authorities to take prompt action to eliminate or contain the risks to human, animal or plant health, 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 8

Confidentiality obligations of the competent authorities

1.  Competent authorities shall ensure that, subject to paragraph 3, information acquired when performing their duties in the context of official controls and other official activities is not disclosed to third parties where, under national or Union legislation, that information is, by its nature, covered by professional secrecy.

For that purpose, Member States shall ensure that appropriate confidentiality obligations are established for staff and other individuals employed during official controls and other official activities.

2.  Paragraph 1 shall also apply to organic control authorities, delegated bodies and natural persons to which specific official control tasks have been delegated and to official laboratories.

3.  Unless there is an overriding public interest in the disclosure of information covered by professional secrecy as referred to in paragraph 1, and without prejudice to situations where disclosure is required by Union or national legislation, such information shall include information whose disclosure would undermine:

4.  The competent authorities, when determining whether there is an overriding public interest in the disclosure of information covered by professional secrecy as referred to in paragraph 1, shall take into account inter alia the possible risks to human, animal or plant health, or to the environment, and the nature, severity and extent of such risks.

5.  The confidentiality obligations provided for in this Article shall not prevent the competent authorities from publishing or making otherwise available to the public information about the outcome of official controls regarding individual operators, provided, without prejudice to situations where disclosure is required by Union or national legislation, that the following conditions are met:

CHAPTER II

Official controls

Section I

General requirements

Article 9

General rules on official controls

1.  Competent authorities shall perform official controls on all operators regularly, on a risk basis and with appropriate frequency, taking account of:

2.  Competent authorities shall perform official controls regularly, with appropriate frequencies determined on a risk basis, to identify possible intentional violations of the rules referred to in Article 1(2), perpetrated through fraudulent or deceptive practices, and taking into account information regarding such violations shared through the mechanisms of administrative assistance provided for in Articles 102 to 108 and any other information pointing to the possibility of such violations.

3.  Official controls that are performed prior to the placing on the market, or the movement of certain animals and goods in view of the issuance of the official certificates or official attestations required by the rules referred to in Article 1(2), as a condition for the placing on the market or the movement of the animals or goods shall be performed in accordance with both of the following:

4.  Official controls shall be performed without prior notice, except where such notice is necessary and duly justified for the official control to be carried out. As regards official controls upon request from the operator, the competent authority may decide whether the official controls are to be performed with or without prior notice. Official controls with prior notice shall not preclude official controls without prior notice.

5.  Official controls shall be performed as much as possible in such a manner that the administrative burden and operational disruption for operators are kept to the minimum necessary, but without this negatively affecting the effectiveness of those controls.

6.  Competent authorities shall perform official controls in the same manner, while taking account of the need to adapt the controls to the specific situations, irrespective of whether the animals and goods concerned are:

7.  To the extent strictly necessary for the organisation of the official controls, Member States of destination may require operators that have animals or goods delivered to them from another Member State to report the arrival of such animals or goods.

Article 10

Operators, processes and activities subject to official controls

1.  To the extent necessary to ascertain compliance with the rules referred to in Article 1(2), competent authorities shall perform official controls on:

2.  Without prejudice to the rules concerning existing lists or registers established on the basis of the rules referred to in Article 1(2), the competent authorities shall draw up and keep up-to-date a list of operators. Where such a list or register already exists for other purposes, it may also be used for the purposes of this Regulation.

3.  The Commission shall adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the setting out of categories of operators to be exempted from the list of operators referred to in paragraph 2 of this Article where their inclusion in such a list would constitute a disproportionate administrative burden for them compared to the risk related to their activities.

Article 11

Transparency of official controls

1.  Competent authorities shall perform official controls with a high level of transparency and shall, at least once a year, make available to the public, including through publication on the internet, relevant information concerning the organisation and the performance of official controls.

They shall also ensure the regular and timely publication of information on the following:

The information referred to in points (a) to (d) of the second subparagraph of this paragraph may be provided, where appropriate, through the publication of the annual report referred to in Article 113(1).

2.  Competent authorities shall establish procedures to ensure that any inaccuracies in the information made available to the public are appropriately rectified.

3.  Competent authorities may publish, or make otherwise available to the public, information about the rating of individual operators based on the outcome of one or more official controls, provided that the following conditions are met:

Article 12

Documented control procedures

1.  Competent authorities shall perform official controls in accordance with documented procedures.

Those procedures shall cover the subject areas for control procedures set out in Chapter II of Annex II and shall contain instructions for staff performing official controls.

2.  Competent authorities shall have control verification procedures in place.

3.  Competent authorities shall:

4.  Paragraphs 1, 2 and 3 shall also apply to delegated bodies and organic control authorities.

Article 13

Written records of official controls

1.  Competent authorities shall draw up written records of every official control that they perform. Those records may be on paper or in electronic form.

Those records shall contain:

2.  Unless the purposes of judicial investigations or the protection of court proceedings require otherwise, the operators subject to an official control shall be provided upon request with a copy of the records provided for in paragraph 1, except where an official certificate or official attestation has been issued. The operator shall be promptly informed in writing by the competent authorities of any case of non-compliance identified through the official controls.

3.  Where official controls require the continuous or regular presence of staff or representatives of the competent authorities on the operator’s premises, the records provided for in paragraph 1 shall be produced with a frequency that enables the competent authorities and the operator to be:

4.  Paragraphs 1, 2 and 3 shall also apply to delegated bodies, organic control authorities and natural persons to which certain official control tasks have been delegated.

Article 14

Methods and techniques for official controls

Official control methods and techniques shall include the following as appropriate:

Article 15

Obligations of operators

1.  To the extent that this is necessary for the performance of official controls or of other official activities, operators shall, where required by the competent authorities, give staff of the competent authorities access to:

2.  During official controls and other official activities, operators shall assist and cooperate with the staff of the competent authorities and organic control authorities in the accomplishment of their tasks.

3.  The operator responsible for a consignment entering the Union shall, in addition to the obligations set out in paragraphs 1 and 2, make available, on paper or in electronic form, and without delay, all information concerning the animals and goods.

4.  The Commission may, by means of implementing acts, lay down rules on the cooperation and exchange of information between operators and competent authorities related to the arrival and unloading of the animals and goods referred to in Article 47(1) where it is necessary to ensure their complete identification and the efficient performance of official controls on such animals and goods. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

5.  For the purpose of Article 10(2) and subject to Article 10(3), operators shall provide the competent authorities with at least the following updated details:

6.  The obligations of operators set out in this Article shall also apply in cases where official controls and other official activities are performed by official veterinarians, official plant health officers, delegated bodies, control authorities and natural persons to which certain official control tasks or certain tasks related to other official activities have been delegated.

Section II

Additional requirements for official controls and other official activities in certain areas

Article 16

Additional requirements

1.  In the areas governed by the rules provided for in this Section, those rules shall apply in addition to the other rules set out in this Regulation.

2.  When adopting delegated acts and implementing acts provided for in this Section, the Commission shall take into account the following:

3.  When adopting delegated acts and implementing acts provided for in this Section, and insofar as this does not prevent the achievement of the objectives pursued by the rules referred to in Article 1(2), the Commission shall also take into account the following:

Article 17

Specific definitions

For the purpose of Article 18:

Article 18

Specific rules on official controls and for action taken by the competent authorities in relation to the production of products of animal origin intended for human consumption

1.  Official controls performed to verify compliance with the rules referred to in Article 1(2) of this Regulation in relation to products of animal origin intended for human consumption shall include the verification of compliance with the requirements laid down in Regulations (EC) No 852/2004, (EC) No 853/2004, (EC) No 1069/2009 and (EC) No 1099/2009 as applicable.

2.  The official controls referred to in paragraph 1 performed in relation to the production of meat shall include:

3.  The competent authority may, on the basis of a risk analysis, allow slaughterhouse staff to assist in the performance of tasks relating to the official controls referred to in paragraph 2 in establishments slaughtering poultry or lagomorphs, or, in establishments slaughtering animals of other species, to carry out specific sampling and testing tasks relating to such controls, on condition that staff:

4.  Where the official controls referred to in points (a) and (c) of paragraph 2 have not identified any shortcoming that would make the meat unfit for human consumption, the health mark shall be applied to domestic ungulates, farmed game mammals other than lagomorphs, and large wild game, by the official veterinarian, under the supervision of the official veterinarian, under the responsibility of the official veterinarian, or, in compliance with the conditions laid down in paragraph 3, by the slaughterhouse staff.

5.  The official veterinarian shall remain responsible for the decisions taken following official controls provided for in paragraphs 2 and 4, even if the performance of an action is assigned by him or her to the official auxiliary.

6.  For the purpose of the official controls referred to in paragraph 1 performed in relation to live bivalve molluscs, the competent authorities shall classify production and relaying areas.

7.  The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning specific rules for the performance of the official controls referred to in paragraphs 2 to 6 of this Article on:

8.  The Commission shall, by means of implementing acts, lay down rules on uniform practical arrangements for the performance of the official controls referred to in this Article regarding:

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

9.  While complying with the objectives of this Regulation and in particular as regards food safety requirements, the Member States may adopt national measures implementing pilot projects limited in time and extent, to evaluate alternative practical arrangements for the performance of official controls on the production of meat. Those national measures shall be notified in accordance with the procedure laid down in Articles 5 and 6 of Directive (EU) 2015/1535. The outcome of the evaluation conducted through the pilot projects shall be communicated to the Commission as soon as available.

10.  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 19

Specific rules on official controls and for action taken by the competent authorities in relation to the residues of relevant substances in food and feed

1.  Official controls to verify compliance with the rules referred to in points (a) and (c) of Article 1(2) shall include official controls, to be performed at any stage of production, processing and distribution, on relevant substances including substances to be used in food contact materials, contaminants, non-authorised, prohibited and undesirable substances whose use or presence on crops or animals or to produce or process food or feed may result in residues of those substances in food or feed.

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 the official controls referred to in paragraph 1 of this Article and for action to be taken by the competent authorities following those official controls. Those delegated acts shall lay down rules on:

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 and for action to be taken by the competent authorities following those official controls, regarding:

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 20

Specific rules on official controls and for action taken by the competent authorities in relation to animals, products of animal origin, germinal products, animal by-products and derived products

1.  Official controls to verify compliance with the rules referred to in points (a), (c), (d), and (e) of Article 1(2) shall include official controls, to be performed at any stage of production, processing and distribution, on animals, on products of animal origin, on germinal products, on animal by-products and on derived products.

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 on animals, on products of animal origin, on germinal products, on animal by-products and on derived products to verify compliance with the Union rules referred to in points (d) and (e) of Article 1(2) and for action taken by the competent authorities following official controls. Those delegated acts shall lay down rules on:

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

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 21

Specific rules on official controls and for action to be taken by the competent authorities in relation to the welfare requirements for animals

1.  Official controls to verify compliance with the rules referred to in point (f) of Article 1(2) shall be performed at all relevant stages of production, processing and distribution along the agri-food chain.

2.  Official controls to verify compliance with the rules laying down welfare requirements for animals in the event of their transport, in particular with Regulation (EC) No 1/2005, shall include:

3.  During the performance of official controls and other official activities, the competent authorities shall take the necessary measures to prevent or reduce to a minimum any delay between the loading of the animals and their departure, or during the transport.

The competent authorities shall not detain animals during the transport unless it is strictly necessary for animal welfare or animal or human health reasons. If animals have to be detained during transport for more than two hours, the competent authorities shall ensure that appropriate arrangements are taken for their care and, where necessary, their feeding, watering, unloading and accommodation.

4.  Where a non-compliance is established following the official controls referred to in point (b) of paragraph 2 and is not corrected by the organiser prior to the long journey, by making appropriate changes to the transport arrangements, the competent authorities shall prohibit that long journey.

5.  Where, following the official controls referred to in point (c) of paragraph 2, the competent authorities establish that animals are not fit to complete the journey, they shall give the order that animals be unloaded, watered, fed and rested until fit to continue their journey.

6.  A notification of non-compliance with the rules referred to in paragraph 1 of this Article for the purposes of Articles 105 and 106 shall be made:

7.  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.

8.  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 Union rules referred to in point (f) of Article 1(2). Those delegated acts shall take into account the animal welfare risk related to the farming activities and to the transport, slaughter and killing of animals, and shall lay down rules on:

9.  The Commission shall, by means of implementing acts, lay down rules on uniform practical arrangements on official controls performed to verify compliance with the Union rules referred to in point (f) of Article 1(2) laying down animal welfare requirements and on action taken by the competent authorities following such official controls, regarding:

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

Article 22

Specific rules on official controls and for action taken by the competent authorities in relation to plant health

1.  Official controls to verify compliance with the rules referred to in point (g) of Article 1(2) shall include official controls on pests, plants, plant products and other objects, and on professional operators and other persons subject to those rules.

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 on plants, plant products and other objects in order to verify compliance with Union rules referred to in point (g) of Article 1(2) applicable to those goods and for action taken by the competent authorities following the performance of those official controls. Those delegated acts shall lay down rules on:

3.  The Commission shall, by means of implementing acts, lay down rules on uniform practical arrangements for the performance of official controls on plants, plant products and other objects in order to verify compliance with Union rules referred to in point (g) of Article 1(2) applicable to those goods and for action taken by the competent authorities following such official controls on:

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 23

Specific rules on official controls and for action taken by the competent authorities in relation to GMOs for the purpose of food and feed production and genetically modified food and feed

1.  Official controls to verify compliance with the rules referred to in points (a), (b) and (c) of Article 1(2) shall include official controls on GMOs for the purpose of food and feed production and on genetically modified food and feed performed at all relevant stages of production, processing and distribution along the agri-food chain.

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 the official controls referred to in paragraph 1 of this Article and for action to be taken by the competent authorities following such official controls. Those delegated acts shall take into account the need to ensure a minimum level of official controls to prevent practices that infringe the rules referred to in point (b) of Article 1(2), and lay down:

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:

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:

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:

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:

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:

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:

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:

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:

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:

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:

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:

Article 31

Conditions for delegating certain tasks related to other official activities

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:

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:

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:

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:

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:

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:

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:

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:

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:

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

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

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

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:

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:

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:

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):

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

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:

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

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:

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:

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:

2.  The Commission shall, by means of implementing acts:

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:

▼M1

▼B

2.  The Commission shall, by means of implementing acts:

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:

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:

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:

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:

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:

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:

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:

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:

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:

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:

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:

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:

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:

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 ( 15 ) 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:

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:

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

1.  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.

2.  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.

3.  Border control posts shall have:

4.  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).

5.  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

1.  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.

2.  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.

3.  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.

4.  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.

5.  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.

6.  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

1.  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.

2.  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).

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

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.

4.  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:

5.  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:

That notification shall be performed via the IMSOC.

6.  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.

7.  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:

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

1.  The competent authorities shall:

2.  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

1.  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.

2.  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:

3.  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.

4.  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

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

2.  The special treatment provided for in paragraph 1 shall:

3.  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

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

2.  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

1.  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).

2.  The approval provided for in paragraph 1 shall specify:

3.  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:

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

5.  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

1.  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:

2.  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

1.  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:

2.  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:

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

1.  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.

2.  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.

3.  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.

4.  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;

5.  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

1.  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:

2.  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.

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

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

1.  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.

2.  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

1.  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;

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

3.  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:

4.  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.

5.  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:

Article 82

Calculation of fees or charges

1.  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:

2.  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.

3.  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.

4.  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

1.  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.

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

3.  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

1.  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.

2.  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

1.  Member States shall ensure a high level of transparency on:

2.  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.

3.  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

1.  Official certification shall result in the issuance of:

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:

Article 88

Signature and issuance of official certificates

1.  Official certificates shall be issued by the competent authorities.

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

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

4.  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

1.  Official certificates shall:

2.  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:

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

Article 91

Official attestations

1.  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.

2.  Official attestations shall:

3.  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:

4.  Competent authorities shall perform regular official controls to verify that:

TITLE III

REFERENCE LABORATORIES AND REFERENCE CENTRES

Article 92

Decision to establish a European Union reference laboratory

1.  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:

2.  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.

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

4.  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

1.  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.

2.  The designations provided for in paragraph 1 shall:

3.  European Union reference laboratories shall:

4.  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.

5.  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:

6.  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

1.  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.

2.  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:

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.

3.  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

1.  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).

2.  The designations provided for in paragraph 1 shall:

3.  European Union reference centres for animal welfare shall:

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:

Article 97

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

1.  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.

2.  The designations provided for in paragraph 1 shall:

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

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:

Article 99

Obligations of the Commission

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

2.  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.

3.  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).

4.  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:

Article 100

Designation of national reference laboratories

1.  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.

2.  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).

3.  National reference laboratories shall:

4.  Member States shall:

5.  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.

6.  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

1.  National reference laboratories shall, in their area of competence:

2.  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

1.  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.

2.  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.

3.  This Title shall be without prejudice to national law:

4.  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:

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

6.  In order to streamline and simplify communication exchanges, the Commission shall, by means of implementing acts, establish a standard format for:

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

Article 103

Liaison bodies

1.  Each Member State shall designate one or more liaison bodies acting as contact points responsible for facilitating the exchange of communications between competent authorities in accordance with Articles 104 to 107.

2.  The designation of liaison bodies shall not preclude direct contacts, exchange of information or cooperation between the staff of competent authorities in different Member States.

3.  Member States shall communicate to the Commission and other Member States the contact details of their liaison bodies designated in accordance with paragraph 1, and any subsequent modification of those details.

4.  The Commission shall publish and update on its website the list of liaison bodies communicated to it by the Member States in accordance with paragraph 3.

5.  All requests for assistance pursuant to Article 104(1), and notifications and communications pursuant to Articles 105, 106 and 107 shall be transmitted by a liaison body to its correspondent in the Member State to which the request or the notification is addressed.

6.  The Commission shall, by means of implementing acts, establish the specifications of the technical tools and the procedures for communication between liaison bodies designated in accordance with paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 104

Assistance on request

1.  Where the competent authorities in a Member State consider that, for the performance of official controls or for the effective follow-up to such controls in their territory, they require data or information from the competent authorities of another Member State, they shall issue a reasoned request for administrative assistance to the competent authorities of that Member State. The requested competent authorities shall:

2.  Documents may be transmitted in their original form or copies may be provided.

3.  By agreement between the requesting competent authorities and the requested competent authorities, staff designated by the former may be present during the official controls and investigations referred to in point (c) of paragraph 1 performed by the requested competent authorities.

In such cases the staff of the requesting competent authorities shall:

Article 105

Assistance without request in the event of non-compliance

1.  When the competent authorities in a Member State become aware of a case of non-compliance, and if such non-compliance may have implications for another Member State, they shall notify such information to the competent authorities of that other Member State without being requested to do so and without undue delay.

2.  The competent authorities notified in accordance with paragraph 1 shall:

Article 106

Assistance in the event of non-compliance creating a risk or a repeated or potentially serious infringement

1.  Where, during official controls performed on animals or goods originating in another Member State, the competent authorities establish that such animals or goods do not comply with the rules referred to in Article 1(2) in such a way as to create a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, or to constitute a potentially serious infringement of those rules, they shall, without delay, notify the competent authorities of the Member State of dispatch and of any other concerned Member State in order to enable those competent authorities to undertake appropriate investigations.

2.  The notified competent authorities shall without delay:

3.  If the notifying competent authorities have reason to believe that the investigations performed or the measures taken by the notified competent authorities do not adequately address the non-compliance established, they shall request the notified competent authorities to complement the official controls performed or the measures taken. In such cases the competent authorities from the two Member States shall:

4.  When official controls performed on animals or goods originating in another Member State show repeated cases of non-compliance as referred to in paragraph 1, the competent authorities of the Member State of destination shall inform the Commission and the competent authorities of the other Member States without delay.

Article 107

Assistance on the basis of information provided by third countries

1.  When competent authorities receive information from a third country indicating non-compliance with rules referred to in Article 1(2) or a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, they shall, without delay:

2.  Information obtained through official controls and investigations performed in accordance with this Regulation may be communicated to the third country referred to in paragraph 1, provided that:

Article 108

Coordinated assistance and follow-up by the Commission

1.  Where the competent authorities in the Member States concerned are unable to agree on appropriate action to address the non-compliance with the rules referred to in Article 1(2), the Commission shall coordinate without delay the measures and actions undertaken by competent authorities in accordance with this Title where information available to the Commission either:

2.  In the cases referred to in paragraph 1, the Commission may:

3.  The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation by establishing rules for the rapid exchange of information in the cases referred to in paragraph 1.

TITLE V

PLANNING AND REPORTING

Article 109

Multi-annual national control plans (MANCP) and a single body for the MANCP

1.  Member States shall ensure that official controls governed by this Regulation are performed by the competent authorities on the basis of a MANCP, the preparation and implementation of which are coordinated across their territory.

2.  Member States shall designate a single body tasked with:

Article 110

Content of the MANCPs

1.  MANCPs shall be prepared so as to ensure that official controls are planned in all the areas governed by the rules referred to in Article 1(2) and in accordance with the criteria laid down in Article 9 and with the rules provided for in Articles 18 to 27.

2.  MANCPs shall contain general information on the structure and organisation of the systems of official control in the Member State concerned in each of the areas covered, and shall contain information on at least the following:

Article 111

Preparation, update and review of MANCPs

1.  Member States shall ensure that the MANCP provided for in Article 109(1) is made available to the public, with the exception of those parts of the plan the disclosure of which could undermine the effectiveness of official controls.

2.  The MANCP shall be regularly updated to adjust it to changes to the rules referred to in Article 1(2), and reviewed to take account at least of the following factors:

3.  Member States shall provide the Commission, upon request, with the latest up-to-date version of their respective MANCP.

Article 112

Coordinated control programmes and information and data collection

With a view to conducting Union-wide targeted assessment of the state of application of the rules referred to in Article 1(2) or establishing the prevalence of certain hazards across the Union, the Commission may adopt implementing acts concerning:

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

Article 113

Annual reports by the Member States

1.  By 31 August every year, each Member State shall submit to the Commission a report setting out:

2.  In order to ensure the uniform presentation of the annual reports provided for in paragraph 1, the Commission shall, by means of implementing acts, adopt and update as necessary standard model forms for the submission of the information and data referred to in that paragraph.

Those implementing acts shall, whenever possible, allow the use of the standard model forms adopted by the Commission for the submission of other reports on official controls that the competent authorities are required to submit to the Commission in accordance with the rules referred to in Article 1(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 114

Annual reports by the Commission

1.  By 31 January every year, the Commission shall make available to the public an annual report on the operation of official controls in the Member States, taking into account:

2.  The annual report provided for in paragraph 1 may, where appropriate, include recommendations on possible improvements to official control systems in Member States and to certain official controls in certain areas.

Article 115

Contingency plans for food and feed

1.  For the application of the general plan for crisis management provided for in Article 55(1) of Regulation (EC) No 178/2002, Member States shall draw up contingency plans for food and feed setting out measures to be applied without delay when food or feed is found to pose a serious risk to human or animal health either directly or through the environment.

2.  The contingency plans for food and feed provided for in paragraph 1 shall specify:

3.  Member States shall review regularly their contingency plans for food and feed to take into account changes in the organisation of the competent authorities and experience gained from implementing the plan and simulation exercises.

4.  The Commission may adopt implementing acts concerning:

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

TITLE VI

UNION ACTIVITIES

CHAPTER I

Commission controls

Article 116

Commission controls in Member States

1.  Commission experts shall perform controls, including audits, in each Member State to:

2.  The controls provided for in paragraph 1 shall be organised in cooperation with the competent authorities of the Member States and shall be performed on a regular basis.

3.  The controls provided for in paragraph 1 may include on-the-spot verifications. The Commission experts may accompany the staff of the competent authorities performing official controls.

4.  Experts from the Member States may assist the Commission experts. National experts accompanying Commission experts shall be given the same rights of access as the Commission experts.

Article 117

Reports by the Commission on controls in Member States

The Commission shall:

Article 118

Programme of the Commission controls in Member States

1.  The Commission shall, by means of implementing acts:

2.  The Commission may, by means of implementing acts, amend its control programme to take account of developments in the areas governed by the rules referred to in Article 1(2). Any such amendment shall be communicated without delay to the Member States.

Article 119

Obligations of the Member States as regards Commission controls

Member States shall:

Article 120

Commission controls in third countries

1.  Commission experts may perform controls in third countries in order to:

2.  The controls provided for in paragraph 1 shall have particular regard to:

3.  In order to facilitate the efficiency and effectiveness of the controls provided for in paragraph 1, the Commission may, prior to performing such controls, request that the third country concerned provide:

4.  The Commission may appoint experts from Member States to assist its own experts during the controls provided for in paragraph 1.

Article 121

Frequency of Commission controls in third countries

The frequency of Commission controls in third countries referred to in Article 120 shall be determined on the basis of the following criteria:

Article 122

Reports by the Commission on controls in third countries

The Commission shall report on the findings of each control performed in accordance with Articles 120 and 121. Its report shall, where appropriate, contain recommendations.

The Commission shall make its reports publicly available.

Article 123

Programme of the Commission controls in third countries

The Commission shall communicate its programme of controls in third countries to Member States in advance and shall report on the results. The Commission may amend that programme to take account of developments in the areas governed by the rules referred to in Article 1(2). Any such amendment shall be communicated to the Member States in advance.

Article 124

Third-country controls in Member States

1.  Member States shall inform the Commission of planned controls in the areas governed by the rules referred to in Article 1(2) on their territory, by the competent authorities of third countries.

2.  Commission experts may participate in the controls referred to in paragraph 1, at the request of the competent authorities of Member States where those controls are being performed.

3.  The participation by Commission experts in the controls referred to in paragraph 1 shall serve in particular to:

CHAPTER II

Conditions for the entry into the Union of animals and goods

Article 125

Information on third countries' control systems

1.  The Commission shall request third countries which intend to export animals and goods to the Union to provide the following accurate and up-to-date information on the general organisation and management of sanitary and phytosanitary control systems in their territory:

2.  The request for information referred to in paragraph 1 shall be proportionate, taking account of the nature of the animals and goods to be exported to the Union and of the specific situation in, and structure of, the third country.

Article 126

Establishment of additional conditions for entry into the Union of animals and goods

1.  The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the conditions to be respected by animals and goods entering the Union from third countries which are necessary to ensure that the animals and goods comply with the relevant requirements established by the rules referred to in Article 1(2), with the exception of points (d), (e), (g) and (h) of Article 1(2), or with requirements recognised to be at least equivalent thereto.

2.  The conditions laid down in the delegated acts referred to in paragraph 1 shall identify animals and goods by referring to their codes from the Combined Nomenclature and may include:

3.  The Commission may, by means of implementing acts, lay down rules on the format and type of official certificates, official attestations, or evidence required in accordance with the rules provided for in point (c) of paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 127

Inclusion in the list of third countries referred to in point (a) of Article 126(2)

1.  The inclusion of a third country or region thereof in the list referred to in point (a) of Article 126(2) shall be made in accordance with paragraphs 2 and 3 of this Article.

2.  The Commission shall approve, by means of implementing acts, the request transmitted to it for the purpose referred to in paragraph 1 of this Article by the third country concerned, accompanied by appropriate evidence and guarantees that the animals and goods concerned from that third country comply with the relevant requirements referred to in Article 126(1) or with requirements equivalent thereto. Those implementing acts shall be adopted and updated in accordance with the examination procedure referred to in Article 145(2).

3.  The Commission shall decide on the request referred to in paragraph 2 taking into account, as appropriate:

4.  The Commission shall delete the reference to a third country or a region of a third country from the list referred to in point (a) of Article 126(2) where the conditions for inclusion on the list cease to be met. The procedure referred to in paragraph 2 of this Article shall apply.

Article 128

Special measures regarding the entry into the Union of certain animals and goods

1.  Where, in cases other than those referred to in Article 53 of Regulation (EC) No 178/2002 and Article 249 of Regulation (EU) 2016/429, there is evidence that the entry into the Union of certain animals or goods originating from a third country, a region thereof or a group of third countries, pose a risk to human, animal or plant health or, as regards GMOs, also to the environment, or where there is evidence that widespread serious non-compliance with the rules referred to in Article 1(2) of this Regulation is taking place, the Commission shall adopt, by means of implementing acts, the measures necessary to contain such risk or put an end to the identified non-compliance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2) of this Regulation.

2.  The measures referred to in paragraph 1 shall identify animals and goods by referring to their codes from the Combined Nomenclature, and may include:

3.  When adopting the measures referred to in paragraph 2, account shall be taken of:

4.  On duly justified imperative grounds of urgency relating to human health and animal health or, as regards GMOs and plant protection products, also to the protection of the environment, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 145(3).

Article 129

Equivalence

1.  In the areas governed by the rules referred to in Article 1(2), with the exclusion of points (d), (e), (g), and (h) of Article 1(2), the Commission may, by means of implementing acts, recognise that measures applied in a third country, or regions thereof, are equivalent to the requirements laid down in those rules, on the basis of:

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

2.  The implementing acts referred to in paragraph 1 shall set out the practical arrangements for the entry of animals and goods into the Union from the third country concerned, or regions thereof, and may include:

3.  The Commission shall, by means of implementing acts, repeal without delay the implementing acts provided for in paragraph 1 of this Article where any of the conditions for the recognition of equivalence cease to be fulfilled. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

CHAPTER III

Training of staff of the competent authorities and of other authorities

Article 130

Training and exchange of staff

1.  The Commission may organise training activities for the staff of the competent authorities and, where appropriate, for staff of other authorities of the Member States involved in investigations of possible infringements of this Regulation and of the rules referred to in Article 1(2).

The Commission shall organise those activities in cooperation with the Member States concerned.

2.  The training activities referred to in paragraph 1 shall facilitate the development of a harmonised approach to official controls and other official activities in Member States. They shall include, as appropriate, training on:

3.  The training activities referred to in paragraph 1 may be open to staff of the competent authorities of third countries and may be organised outside the Union.

4.  Competent authorities shall ensure that the knowledge acquired through the training activities referred to in paragraph 1 of this Article is disseminated as necessary and appropriately used in the staff training activities referred to in Article 5(4).

Training activities aimed at disseminating such knowledge shall be included in the training programmes referred to in Article 5(4).

5.  The Commission may organise, in cooperation with the Member States, programmes for the exchange of staff of the competent authorities performing official controls or other official activities between two or more Member States.

Such exchange may take place through the temporary secondment of staff of the competent authorities from one Member State to the other or through the exchange of such staff between the relevant competent authorities.

6.  The Commission may, by means of implementing acts, lay down rules on the organisation of the training activities referred to in paragraph 1, and of the programmes referred to in paragraph 5, of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

CHAPTER IV

Information management system

Article 131

Information management system for official controls (IMSOC)

1.  The Commission shall, in collaboration with the Member States, set up and manage a computerised information management system for official controls (IMSOC) for the integrated operation of the mechanisms and tools through which data, information and documents concerning official controls and other official activities are managed, handled, and automatically exchanged.

2.  The processing of personal data by the Member States and the Commission through the IMSOC and any one of its components shall only be carried out for the purpose of performing official controls and other official activities in accordance with this Regulation and with the rules referred to in Article 1(2).

Article 132

General functionalities of the IMSOC

The IMSOC shall:

Article 133

Use of the IMSOC in the case of animals and goods subject to certain official controls

1.  In the case of animals or goods whose movements within the Union or placing on the market are subject to specific requirements or procedures established by the rules referred to in Article 1(2), the IMSOC shall enable the competent authorities at the place of dispatch and other competent authorities responsible for performing official controls on those animals or goods to exchange, in real time, data, information and documents concerning animals or goods being moved from one Member State to another and on official controls performed.

The first subparagraph of this paragraph shall not apply to goods subject to the rules referred to in points (g) and (h) of Article 1(2).

2.  In the case of exported animals and goods for which Union rules apply in relation to the issuance of the export certificate, the IMSOC shall enable the competent authorities of the place of dispatch and other competent authorities responsible for performing official controls to exchange, in real time, data, information and documents concerning such animals and goods and the outcome of controls performed on those animals and goods.

3.  In the case of animals or goods subject to the official controls referred to in Articles 44 to 64, the IMSOC shall:

4.  The IMSOC shall, for the purpose of this Article, integrate the existing Traces system.

Article 134

The functioning of the IMSOC

The Commission shall adopt implementing acts for the functioning of the IMSOC which lay down:

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

Article 135

Data protection

▼C1

1.  Directive 95/46/EC and Regulation (EC) No 45/2001 of the European Parliament and of the Council ( 17 ) shall apply to the extent that the information processed through the IMSOC contains personal data as defined in point (a) of Article 2 of Directive 95/46/EC and in point (a) of Article 2 of Regulation (EC) No 45/2001.

▼B

2.  In relation to their responsibilities to transmit the relevant information to the IMSOC and the processing of any personal data that might result from that activity, the competent authorities of the Member States shall be regarded as controllers as defined in point (d) of Article 2 of Directive 95/46/EC.

3.  In relation to its responsibility to manage the IMSOC and the processing of any personal data that might result from that activity, the Commission shall be regarded as controller as defined in point (d) of Article 2 of Regulation (EC) No 45/2001.

4.  Member States may restrict the rights and obligations under Article 6(1), Article 10, Article 11(1) and Article 12 of Directive 95/46/EC as necessary to safeguard the interest referred to in points (d) and (f) of Article 13(1) of that Directive.

5.  The Commission may restrict the rights and obligations under Article 4(1), Article 11, Article 12(1) and Articles 13 to 17 of Regulation (EC) No 45/2001 where such restriction constitutes a necessary measure to safeguard the interests referred to in points (a) and (e) of Article 20(1) of that Regulation during the period in which actions are being planned or performed to verify compliance with food or feed law or to ensure the enforcement of food or feed law in the specific case to which the information relates.

Article 136

Data security

Member States and the Commission shall ensure that the IMSOC complies with the rules on data security adopted by the Commission under Article 17 of Directive 95/46/EC and Article 22 of Regulation (EC) No 45/2001 respectively.

TITLE VII

ENFORCEMENT ACTION

CHAPTER I

Actions by the competent authorities and penalties

Article 137

General obligations of the competent authorities as regards enforcement action

1.  When acting in accordance with this Chapter, the competent authorities shall give priority to action to be taken to eliminate or contain risks to human, animal and plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment.

2.  In case of suspicion of non-compliance, the competent authorities shall perform an investigation in order to confirm or to eliminate that suspicion.

3.  Where necessary, actions taken in accordance with paragraph 2 shall include:

Article 138

Actions in the event of established non-compliance

1.  Where the non-compliance is established, the competent authorities shall take:

When deciding which measures to take, the competent authorities shall take account of the nature of that non-compliance and the operator’s past record with regard to compliance.

2.  When acting in accordance with paragraph 1 of this Article, competent authorities shall take any measure they deem appropriate to ensure compliance with the rules referred to in Article 1(2), including, but not limited, to the following:

3.  The competent authorities shall provide the operator concerned, or its representative, with:

4.  All expenditure incurred under this Article shall be borne by the responsible operators.

5.  The competent authorities, in the case of issuance of false or misleading official certificates or in the case of abuse of official certificates, shall take appropriate measures, including:

Article 139

Penalties

1.  Member States shall lay down the rules on penalties applicable to infringements of this Regulation and take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by 14 December 2019, notify those provisions to the Commission and shall notify it without delay of any subsequent amendment affecting them.

2.  Member States shall ensure that financial penalties for violations of this Regulation and of the rules referred to in Article 1(2), perpetrated through fraudulent or deceptive practices, reflect, in accordance with national law, at least either the economic advantage for the operator or, as appropriate, a percentage of the operator's turnover.

Article 140

Reporting of infringements

1.  Member States shall ensure that competent authorities have effective mechanisms to enable reporting of actual or potential infringements of this Regulation.

2.  The mechanisms referred to in paragraph 1 shall include at least:

CHAPTER II

Union enforcement measures

Article 141

Serious disruption in a Member State's control system

1.  Where the Commission has evidence of a serious disruption in a Member State’s control system and such disruption may constitute a widespread risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, or result in a widespread infringement of the rules referred to in Article 1(2), it shall, by means of implementing acts, adopt one or more of the following measures, to be applied until such disruption is eliminated:

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

2.  The measures referred to in paragraph 1 shall be adopted only where the Member State concerned has not corrected the situation upon request and within the appropriate time limit set by the Commission.

3.  On duly justified imperative grounds of urgency relating to human and animal health or, as regards GMOs and plant protection products, also to the protection of the environment, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 145(3).

TITLE VIII

COMMON PROVISIONS

CHAPTER I

Procedural provisions

Article 142

Amendment of Annexes and references to European standards

1.  The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning amendments to Annexes II and III, in order to take into account changes to the rules referred to in Article 1(2), technical progress and scientific developments.

2.  The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the references to the European standards referred to in point (b)(iv) of Article 29, point (e) of Article 37(4) and point (a) of Article 93(3), in the event that CEN amends those standards.

Article 143

Data protection

1.  Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation.

2.  Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission pursuant to this Regulation.

Article 144

Exercise of the delegation

1.  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.  The power to adopt delegated acts referred to in Articles 18(7) and 21(8), Article 41, Articles 45(4) and 47(3), Article 48, Article 50(4), Article 51, and Articles 53(1), 62(3), 64(2) and (5), 77(1) and (2), 92(4), 99(2), 100(6), 101(2), 126(1), 142(1) and (2), 149(2), 150(3), 154(3), 155(3) and 165(3) shall be conferred on the Commission for a period of five years from 28 April 2017. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3.  The delegation of power referred to in Articles 18(7) and 21(8), Article 41, Articles 45(4) and 47(3), Article 48, Article 50(4), Article 51, and Articles 53(1), 62(3), 64(2) and (5), 77(1) and (2), 92(4), 99(2), 100(6), 101(2), 126(1), 142(1) and (2), 149(2), 150(3), 154(3), 155(3) and 165(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.  Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5.  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.  A delegated act adopted pursuant to Articles 18(7) and 21(8), Article 41, Articles 45(4) and 47(3), Article 48, Article 50(4), Article 51, and Articles 53(1), 62(3), 64(2) and (5), 77(1) and (2), 92(4), 99(2), 100(6), 101(2), 126(1), 142(1) and (2), 149(2), 150(3), 154(3), 155(3) and 165(3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Article 145

Committee procedure

1.  The Commission shall be assisted by the Standing Committee on Plants, Animals, Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002, except in respect of Articles 25 and 26 of this Regulation for which the Commission shall be assisted respectively by the committees established pursuant to Regulation (EC) No 834/2007 and to Regulation (EU) No 1151/2012. Those committees shall be committees within the meaning of Regulation (EU) No 182/2011.

2.  Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.

3.  Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

CHAPTER II

Transitional and final provisions

Article 146

Repeals

1.  Regulations (EC) No 854/2004 and (EC) No 882/2004, Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Decision 92/438/EEC, are repealed with effect from 14 December 2019.

2.  References to the repealed acts shall be construed as references to this Regulation and shall be read in accordance with the correlation tables in Annex V.

Article 147

Relation with Regulation (EC) No 882/2004

The designation of each of the European Union reference laboratories referred to in Annex VII to Regulation (EC) No 882/2004 shall remain effective until a designation of a European Union reference laboratory in the same area takes place in accordance with Article 93 of this Regulation.

Article 148

Relation with Regulations (EC) No 852/2004 and (EC) No 853/2004 regarding approval of food business establishments

1.  Competent authorities shall establish procedures for food business operators to follow when applying for the approval of their establishments in accordance with Regulations (EC) No 852/2004 and (EC) No 853/2004.

2.  Upon receipt of an application for approval from a food business operator, the competent authority shall make an on-site visit.

3.  The competent authority shall approve an establishment for the activities concerned only if the food business operator has demonstrated that it complies with the relevant requirements of food law.

4.  The competent authority may grant conditional approval if it appears that the establishment meets all the infrastructure and equipment requirements. It shall grant full approval only if it appears from a new official control of the establishment, carried out within three months of granting conditional approval, that the establishment meets the other relevant requirements of food law. If clear progress has been made but the establishment still does not meet all of the relevant requirements, the competent authority may prolong the conditional approval. However, conditional approval shall not exceed a total of six months, except in the case of factory and freezer vessels flying the flag of Member States, for which such conditional approval shall not exceed a total of 12 months.

5.  The competent authority shall keep the approval of establishments under review when carrying out official controls.

Article 149

Transitional measures related to the repeals of Directives 91/496/EEC and 97/78/EC

1.  

2.  The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the date referred to in paragraph 1 of this Article. That date shall be the date of application of the corresponding rules to be established pursuant to the delegated or implementing acts provided for in Article 47(2), Article 48, points (b), (c) and (d) of Article 51(1), point (a) of Article 53(1), Article 54(1) and (3), and point (a) of Article 58.

Article 150

Transitional measures related to the repeal of Directive 96/23/EC

1.  Competent authorities shall continue to perform the official controls necessary to detect the presence of the substances and groups of residues listed in Annex I to Directive 96/23/EC, in accordance with Annexes II, III and IV to that Directive, instead of the corresponding provisions of this Regulation, until 14 December 2022 or an earlier date to be determined in the delegated act adopted in accordance with paragraph 3 of this Article.

2.  Article 29(1) and (2) of Directive 96/23/EC shall continue to apply instead of the corresponding provisions of this Regulation until 14 December 2022 or an earlier date to be determined in the delegated act adopted in accordance with paragraph 3 of this Article.

3.  The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the earlier date referred to in paragraphs 1 and 2 of this Article. That date shall be the date of application of the corresponding rules to be established pursuant to the delegated or implementing acts provided for in Articles 19 and 112.

Article 151

Amendments to Directive 98/58/EC

Directive 98/58/EC is amended as follows:

Article 152

Amendments to Directive 1999/74/EC

Directive 1999/74/EC is amended as follows:

Article 153

Amendments to Regulation (EC) No 999/2001

Regulation (EC) No 999/2001 is amended as follows:

Article 154

Amendments to Regulation (EC) No 1/2005 and related transitional measures

1.  Regulation (EC) No 1/2005 is amended as follows:

2.  Articles 14, 15, 16 and 21, Article 22(2), and Articles 23, 24 and 26 of Regulation (EC) No 1/2005 shall continue to apply, instead of the corresponding provisions of this Regulation, until 14 December 2022 or an earlier date to be determined in the delegated act adopted in accordance with paragraph 3 of this Article.

3.  The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the date referred to in paragraph 2 of this Article. That date shall be the date of application of the corresponding rules to be established pursuant to the delegated or implementing acts provided for in Article 21.

Article 155

Amendments to Regulation (EC) No 396/2005 and related transitional measures

1.  Articles 26 and 27, Article 28(1) and (2) and Article 30 of Regulation (EC) No 396/2005 are deleted.

2.  Article 26, Article 27(1) and Article 30 of Regulation (EC) No 396/2005 shall continue to apply instead of the corresponding provisions of this Regulation until 14 December 2022 or an earlier date to be determined in the delegated act adopted in accordance with paragraph 3 of this Article.

3.  The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the date referred to in paragraph 2 of this Article. That date shall be the date of application of the corresponding rules to be established pursuant to the delegated or implementing acts provided for in Article 19.

Article 156

Amendments to Directive 2007/43/EC

Directive 2007/43/EC is amended as follows:

Article 157

Amendments to Directive 2008/119/EC

Directive 2008/119/EC is amended as follows:

Article 158

Amendments to Directive 2008/120/EC

Directive 2008/120/EC is amended as follows:

Article 159

Amendments to Regulation (EC) No 1099/2009

Regulation (EC) No 1099/2009 is amended as follows:

Article 160

Amendments to Regulation (EC) No 1069/2009

Regulation (EC) No 1069/2009 is amended as follows:

Article 161

Amendments to Regulation (EC) No 1107/2009

Regulation (EC) No 1107/2009 is amended as follows:

Article 162

Amendments to Regulation (EU) No 1151/2012

Regulation (EU) No 1151/2012 is amended as follows:

Article 163

Amendments to Regulation (EU) No 652/2014

Regulation (EU) No 652/2014 is amended as follows:

Article 164

Amendments to Regulation (EU) 2016/429 and related transitional provisions

1.  Regulation (EU) 2016/429 is amended as follows:

2.  The following provisions shall continue to apply in relation to the matters governed by Regulation (EU) 2016/429, until the date of application of that Regulation:

3.  Having regard to Article 14 of Regulation (EU) 2016/429 and notwithstanding the date of application provided for in that Regulation, for the purpose of Article 31(2) of this Regulation, the condition for its application shall be considered to be fulfilled already from 14 December 2019.

Article 165

Amendments to Regulation (EU) 2016/2031 and related transitional provisions

1.  Regulation (EU) 2016/2031 is amended as follows:

2.  

3.  The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the date referred to in paragraph 2 of this Article.

4.  Without prejudice to paragraphs 2 and 3 of this Article and the date of application provided for in Article 167(1), the Commission shall adopt the delegated acts referred to in points (a) and (e) of Article 53(1), as regards goods referred to in point (c) of Article 47(1), at the latest 12 months before their date of application.

Article 166

Transitional measures for the adoption of delegated and implementing acts

Without prejudice to the dates of application referred to in Article 167 and transitional provisions provided for in this Chapter, the Commission is empowered to adopt delegated and implementing acts provided for in this Regulation as from 28 April 2017. Such acts shall apply from the date of application in accordance with Article 167, without prejudice to any transitional rules provided for in this Chapter.

Article 167

Entry into force and application

1.  This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Unless otherwise provided for in paragraphs 2 to 4, it shall apply from 14 December 2019.

2.  In the area governed by the rules referred to in point (g) of Article 1(2), Article 34(1), (2) and (3), point (e) of Article 37(4) and Article 37(5) shall apply from 29 April 2022.

3.  Articles 92 to 101 of this Regulation shall apply from 29 April 2018, instead of Articles 32 and 33 of Regulation (EC) No 882/2004, which is repealed by this Regulation.

4.  Article 163 shall apply from 28 April 2017.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

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ANNEX I

TERRITORIES REFERRED TO IN POINT 40 OF ARTICLE 3, EXCEPT FOR THE APPLICATION OF POINT (G) OF ARTICLE 1(2)

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ANNEX II

TRAINING OF STAFF OF THE COMPETENT AUTHORITIES

CHAPTER I

Subject matter for the training of staff performing official controls and other official activities

CHAPTER II

Subject areas for control procedures

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ANNEX III

CHARACTERISATION OF METHODS OF ANALYSIS

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ANNEX IV

CHAPTER I

Fees or charges for the official controls on consignments of animals and goods entering the Union

I.   CONSIGNMENTS OF LIVE ANIMALS

II.   CONSIGNMENTS OF MEAT

III.   CONSIGNMENTS OF FISHERY PRODUCTS

IV.   CONSIGNMENTS OF MEAT PRODUCTS, POULTRY MEAT, WILD GAME MEAT, RABBIT MEAT OR FARMED GAME MEAT

V.   CONSIGNMENTS OF OTHER PRODUCTS OF ANIMAL ORIGIN DIFFERENT FROM MEAT PRODUCTS FOR HUMAN CONSUMPTION

VI.   CONSIGNMENTS OF ANIMAL BY-PRODUCTS AND FEED OF ANIMAL ORIGIN

VII.   CONSIGNMENTS OF ANIMALS AND GOODS FROM THIRD COUNTRIES TRANSITING OR TRANSHIPPED

EUR 30 for consignment increased by EUR 20 per quarter of an hour for every member of staff involved in the controls.

VIII.   CONSIGNMENTS OF PLANTS, PLANT PRODUCTS AND OTHER PRODUCTS, OBJECTS AND MATERIALS CAPABLE OF HARBOURING OR SPREADING PESTS OF PLANTS

Where a consignment does not consist exclusively of products coming under the description of the relevant indent, those parts thereof consisting of products coming under the description of the relevant indent (lot or lots) shall be treated as a separate consignment.

CHAPTER II

Fees or charges for the official controls in slaughterhouses, cutting plants, game-processing plants, milk production and producing and placing on the market fishery products and aquaculture productS

I.   FEES OR CHARGES FOR THE OFFICIAL CONTROLS IN SLAUGHTERHOUSES

II.   FEES OR CHARGES FOR THE OFFICIAL CONTROLS IN CUTTING PLANTS

Per tonne of meat:

III.   FEES OR CHARGES FOR THE OFFICIAL CONTROLS IN GAME-PROCESSING PLANTS

IV.   FEES OR CHARGES FOR THE OFFICIAL CONTROLS ON MILK PRODUCTION

V.   FEES OR CHARGES FOR THE OFFICIAL CONTROLS ON PRODUCING AND PLACING ON THE MARKET FISHERY PRODUCTS AND AQUACULTURE PRODUCTS

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ANNEX V

CORRELATION TABLES REFERRED TO IN ARTICLE 146(2)

1.   Regulation (EC) No 882/2004

2.   Directive 96/23/EC

3.   Directives 89/662/EEC and 90/425/EEC

4.   Directives 97/78/EC and 91/496/EEC

5.   Directive 96/93/EC

6.   Directive 89/608/EEC

7.   Decision 92/438/EEC

8.   Regulation (EC) No 854/2004

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( 1 ) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

( 2 ) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).

( 3 ) Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (OJ L 189, 20.7.2007, p. 1).

( 4 ) Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55).

( 5 ) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1).

( 6 ) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

( 7 ) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).

( 8 ) Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1).

( 9 ) Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, p. 1).

( 10 ) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).

( 11 ) Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L 201, 27.7.2012, p. 60).

( 12 ) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

( 13 ) Commission Implementing Regulation (EU) 2015/1375 of 10 August 2015 laying down specific rules on official controls for Trichinella in meat (OJ L 212, 11.8.2015, p. 7).

( 14 ) Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non-commercial movement of pet animals and repealing Regulation (EC) No 998/2003 (OJ L 178, 28.6.2013, p. 1).

( 15 ) Commission Regulation (EU) No 284/2011 of 22 March 2011 laying down specific conditions and detailed procedures for the import of polyamide and melamine plastic kitchenware originating in or consigned from the People’s Republic of China and Hong Kong Special Administrative Region, China (OJ L 77, 23.3.2011, p. 25).

( 16 ) Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, p. 1).

( 17 ) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).

( *1 ) Regulation ►C1  (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) ( ►C1  OJ L 95, 7.4.2017, p. 1 ◄ ).’;

( *2 ) Regulation ►C1  (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) ( ►C1  OJ L 95, 7.4.2017, p. 1 ◄ ).’;

( *3 ) Regulation ►C1  (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) ( ►C1  OJ L 95, 7.4.2017, p. 1 ◄ ).’;

( *4 ) Regulation ►C1  (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) ( ►C1  OJ L 95, 7.4.2017, p. 1 ◄ ).’;

( *5 ) Regulation ►C1  (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) ( ►C1  OJ L 95, 7.4.2017, p. 1 ◄ ).’;

( *6 ) Regulation ►C1  (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) ( ►C1  OJ L 95, 7.4.2017, p. 1 ◄ ).’;

( *7 ) Regulation ►C1  (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) ( ►C1  OJ L 95, 7.4.2017, p. 1 ◄ ).’;

( *8 ) Regulation ►C1  (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) ( ►C1  OJ L 95, 7.4.2017, p. 1 ◄ ).’;

( *9 ) Regulation ►C1  (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) ( ►C1  OJ L 95, 7.4.2017, p. 1 ◄ ).

( *10 ) Regulation (EU) 2016/1012 of the European Parliament and of the Council of 8 June 2016 on zootechnical and genealogical conditions for the breeding, trade in and entry into the Union of purebred breeding animals, hybrid breeding pigs and the germinal products thereof and amending Regulation (EU) No 652/2014, Council Directives 89/608/EEC and 90/425/EEC and repealing certain acts in the area of animal breeding (“Animal Breeding Regulation”) (OJ L 171, 29.6.2016, p. 66).’;

( *11 ) Regulation ►C1  (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) ( ►C1  OJ L 95, 7.4.2017, p. 1 ◄ ).’;

( *12 ) Regulation ►C1  (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) ( ►C1  OJ L 95, 7.4.2017, p. 1 ◄ ).’;