02017R0625 — EN — 07.04.2017 — 000.001

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►B 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)





Corrected by:









▼B

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:

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

(b) the financing of official controls;

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

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

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

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

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:

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

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

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

(d) animal health requirements;

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

(f) welfare requirements for animals;

(g) protective measures against pests of plants;

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

(i) organic production and labelling of organic products;

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

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:

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

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

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

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:

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

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

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:

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

(2) ‘feed law’ means the laws, regulations and administrative provisions governing feed in general and feed safety in particular, whether at Union or national level at any stage of production, processing and distribution or use of feed;

(3) ‘competent authorities’ means:

(a) the central authorities of a Member State responsible for the organisation of official controls and of other official activities, in accordance with this Regulation and the rules referred to in Article 1(2);

(b) any other authority to which that responsibility has been conferred;

(c) where appropriate, the corresponding authorities of a third country;

(4) ‘organic control authority’ means a public administrative organisation for organic production and labelling of organic products of a Member State to which the competent authorities have conferred, in whole or in part, their competences in relation to the application of Council Regulation (EC) No 834/2007 ( 3 ), including, where appropriate, the corresponding authority of a third country or operating in a third country;

(5) ‘delegated body’ means a separate legal person to which the competent authorities have delegated certain official control tasks or certain tasks related to other official activities;

(6) ‘control verification procedures’ means the arrangements put in place and actions performed by the competent authorities for the purpose of ensuring that official controls and other official activities are consistent and effective;

(7) ‘control system’ means a system comprising the competent authorities and the resources, structures, arrangements and procedures set up in a Member State to ensure that official controls are performed in accordance with this Regulation and with the rules referred to in Articles 18 to 27;

(8) ‘control plan’ means a description established by the competent authorities containing information on the structure and organisation of the official control system, and of its operation and the detailed planning of official controls to be performed, over a period of time, in each of the areas governed by the rules referred to in Article 1(2);

(9) ‘animals’ means animals as defined in point (1) of Article 4 of Regulation (EU) 2016/429;

(10) ‘animal disease’ means disease as defined in point (16) of Article 4 of Regulation (EU) 2016/429;

(11) ‘goods’ means all that is subject to one or more of the rules referred to in Article 1(2), excluding animals;

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

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

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

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

(16) ‘plants’ means plants as defined in point (1) of Article 2 of Regulation (EU) 2016/2031;

(17) ‘pests of plants’ means pests as defined in Article 1(1) of Regulation (EU) 2016/2031;

(18) ‘plant protection products’ means plant protection products as referred to in Article 2(1) of Regulation (EC) No 1107/2009;

(19) ‘products of animal origin’ means products of animal origin as defined in point 8.1 of Annex I to Regulation (EC) No 853/2004 of the European Parliament and of the Council ( 4 );

(20) ‘germinal products’ means germinal products as defined in point (28) of Article 4 of Regulation (EU) 2016/429;

(21) ‘plant products’ means plant products as defined in point (2) of Article 2 of Regulation (EU) 2016/2031;

(22) ‘other objects’ means other objects as defined in point (5) of Article 2 of Regulation (EU) 2016/2031;

(23) ‘hazard’ means any agent or condition with the potential to have an adverse effect on human, animal or plant health, animal welfare or the environment;

(24) ‘risk’ means a function of the probability of an adverse effect on human, animal or plant health, animal welfare or the environment and of the severity of that effect, consequential to a hazard;

(25) ‘official certification’ means the procedure by which assurance concerning compliance with one or more requirements laid down in the rules referred to in Article 1(2) is provided by the competent authorities;

(26) ‘certifying officer’ means:

(a) any official of the competent authorities authorised to sign official certificates by such authorities; or

(b) any other natural person who is authorised by the competent authorities to sign official certificates in accordance with the rules referred to in Article 1(2);

(27) ‘official certificate’ means a paper or electronic document signed by the certifying officer and providing assurance concerning compliance with one or more requirements laid down in the rules referred to in Article 1(2);

(28) ‘official attestation’ means any label, mark or other form of attestation issued by the operators under the supervision, through dedicated official controls, of the competent authorities or by the competent authorities themselves, and providing assurance concerning compliance with one or more requirements laid down in this Regulation or in the rules referred to in Article 1(2);

(29) ‘operator’ means any natural or legal person subject to one or more of the obligations provided for in the rules referred to in Article 1(2);

(30) ‘audit’ means a systematic and independent examination to determine whether activities and the related results of such activities comply with planned arrangements and whether these arrangements are applied effectively and are suitable to achieve the objectives;

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

(32) ‘official veterinarian’ means a veterinarian appointed by a competent authority, either as staff or otherwise, and appropriately qualified to perform official controls and other official activities in accordance with this Regulation and the relevant rules referred to in Article 1(2);

(33) ‘official plant health officer’ means a natural person appointed by a competent authority, either as staff or otherwise, and appropriately trained to perform official controls and other official activities in accordance with this Regulation and the relevant rules referred to in point (g) of Article 1(2);

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

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

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

(37) ‘consignment’ means a number of animals or quantity of goods covered by the same official certificate, official attestation or any other document, conveyed by the same means of transport and coming from the same territory or third country, and, except for goods subject to the rules referred to in point (g) of Article 1(2), being of the same type, class or description;

(38) ‘border control post’ means a place, and the facilities belonging to it, designated by a Member State for the performance of the official controls provided for in Article 47(1);

(39) ‘exit point’ means a border control post or any other place designated by a Member State where animals, falling within the scope of Regulation (EC) No 1/2005, leave the customs territory of the Union;

(40) ‘entering the Union’ or ‘entry into the Union’ means the action of bringing animals and goods into one of the territories that are listed in Annex I to this Regulation from outside these territories, except in relation to the rules referred to in point (g) of Article 1(2) for which these terms mean the action of bringing goods into the ‘Union territory’ as defined in the second subparagraph of Article 1(3) of Regulation (EU) 2016/2031;

(41) ‘documentary check’ means the examination of the official certificates, official attestations and other documents including documents of a commercial nature, which are required to accompany the consignment as provided for by the rules referred to in Article 1(2), by Article 56(1) or by implementing acts adopted in accordance with Articles 77(3), 126(3), 128(1) and 129(1);

(42) ‘identity check’ means a visual inspection to verify that the content and the labelling of a consignment, including the marks on animals, seals and means of transport, correspond to the information provided in the official certificates, official attestations and other documents accompanying it;

(43) ‘physical check’ means a check on animals or goods and, as appropriate, checks on packaging, the means of transport, labelling and temperature, the sampling for analysis, testing or diagnosis and any other check necessary to verify compliance with the rules referred to in Article 1(2);

(44) ‘transit’ means movement from one third country to another third country passing under customs supervision through one of the territories listed in Annex I or from one of the territories listed in Annex I to another territory listed in Annex I after passing through the territory of a third country, except in relation to the rules referred to in point (g) of Article 1(2), for which it means one of the following;

(a) movement from one third country to another third country, as defined in the first subparagraph of Article 1(3) of Regulation (EU) 2016/2031 passing under customs supervision through the ‘Union territory’, as defined in the second subparagraph of Article 1(3) of that Regulation; or

(b) movement from the ‘Union territory’ to another part of the ‘Union territory’, as defined in the second subparagraph of Article 1(3) of Regulation (EU) 2016/2031, passing through the territory of a third country as defined in the first subparagraph of Article 1(3) of that Regulation;

(45) ‘supervision by the customs authorities’ means customs supervision as defined in point (27) of Article 5 of Regulation (EU) No 952/2013 of the European Parliament and of the Council ( 5 );

(46) ‘control by the customs authorities’ means customs controls as defined in point (3) of Article 5 of Regulation (EU) No 952/2013;

(47) ‘official detention’ means the procedure by which the competent authorities ensure that animals and goods subject to official controls are not moved or tampered with pending a decision on their destination; it includes storage by operators in accordance with the instructions and under the control of the competent authorities;

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

(49) ‘official auxiliary’ means a representative of the competent authorities trained in accordance with the requirements established under Article 18 and employed to perform certain official control tasks or certain tasks related to other official activities;

(50) ‘meat and edible meat offal’ means, for the purpose of point (a) of Article 49(2) of this Regulation, the products listed in sub-Chapters 0201 to 0208 of Chapter 2 of Section I of Part II of Annex I to Council Regulation (EEC) No 2658/87 ( 6 );

(51) ‘health mark’ means a mark applied after the official controls referred to in points (a) and (c) of Article 18(2) have been performed and which attests that the meat is fit for human consumption.







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:

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

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

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:

(a) the competent authorities designated in accordance with paragraph 1;

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

(c) the organic control authorities referred to in paragraph 3;

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

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:

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

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

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

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

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

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

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

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

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

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:

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

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

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

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:

(a) the purpose of inspections, investigations or audits;

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

(c) the protection of court proceedings and legal advice.

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:

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

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







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:

(a) identified risks associated with:

(i) animals and goods;

(ii) the activities under the control of operators;

(iii) the location of the activities or operations of operators;

(iv) the use of products, processes, materials or substances that may influence food safety, integrity and wholesomeness, or feed safety, animal health or animal welfare, plant health or, in the case of GMOs and plant protection products, that may also have an adverse impact on the environment;

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

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

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

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

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:

(a) the rules referred to in Article 1(2);

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

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:

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

(b) to be exported from the Union; or

(c) entering the Union.

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:

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

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

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

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:

(a) the type, number and outcome of official controls;

(b) the type and number of cases of non-compliance detected;

(c) the type and number of cases where measures were taken by the competent authorities in accordance with Article 138; and

(d) the type and number of cases where the penalties referred to in Article 139 were imposed.

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:

(a) the rating criteria are objective, transparent and publicly available; and

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

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:

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

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

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:

(a) a description of the purpose of the official controls;

(b) the control methods applied;

(c) the outcome of the official controls; and

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

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:

(a) regularly informed of the level of compliance; and

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

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:

(a) an examination of the controls that operators have put in place and of the results obtained;

(b) an inspection of:

(i) equipment, means of transport, premises and other places under their control and their surroundings;

(ii) animals and goods, including semi-finished goods, raw materials, ingredients, processing aids and other products used for the preparation and production of goods or for feeding or treating animals;

(iii) cleaning and maintenance products and processes;

(iv) traceability, labelling, presentation, advertising and relevant packaging materials including materials intended to come into contact with food;

(c) controls on the hygiene conditions in the operators’ premises;

(d) an assessment of procedures on good manufacturing practices, good hygiene practices, good farming practices, and of procedures based on the principles of hazard analysis critical control points (HACCP);

(e) an examination of documents, traceability records and other records which may be relevant to the assessment of compliance with the rules referred to in Article 1(2), including, where appropriate, documents accompanying food, feed and any substance or material entering or leaving an establishment;

(f) interviews with operators and with their staff;

(g) the verification of measurements taken by the operator and other test results;

(h) sampling, analysis, diagnosis and tests;

(i) audits of operators;

(j) any other activity required to identify cases of non-compliance.

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:

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

(b) their computerised information management systems;

(c) the animals and goods under their control;

(d) their documents and any other relevant information.

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:

(a) their name and legal form; and

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

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:

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

(b) scientific and technological developments;

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

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

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

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:

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

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

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

Article 17

Specific definitions

For the purpose of Article 18:

(a) ‘under the responsibility of the official veterinarian’ means that the official veterinarian assigns the performance of an action to an official auxiliary;

(b) ‘under the supervision of the official veterinarian’ means that an action is performed by an official auxiliary under the responsibility of the official veterinarian and the official veterinarian is present on the premises during the time necessary to perform that action;

(c) ‘ante-mortem inspection’ means the verification, prior to slaughtering activities, of human and animal health and animal welfare requirements, including, where appropriate, the clinical examination of each individual animal, and the verification of the food chain information as referred to in Section III of Annex II to Regulation (EC) No 853/2004;

(d) ‘post-mortem inspection’ means the verification in the slaughterhouse or game-handling establishment of compliance with requirements applicable to:

(i) carcases as defined in point 1.9 of Annex I to Regulation (EC) No 853/2004 and offal as defined in point 1.11 of that Annex, for the purpose of deciding if the meat is fit for human consumption,

(ii) safe removal of specified risk material, and

(iii) the health and welfare of the animals.

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:

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

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

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

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

(i) the hygiene of meat production;

(ii) the presence of residues of veterinary medicinal products and contaminants in products of animal origin intended for human consumption;

(iii) audits of good hygiene practices and procedures based on HACCP principles;

(iv) laboratory tests to detect the presence of zoonotic agents and animal diseases and to verify compliance with the microbiological criterion as defined in point (b) of Article 2 of Commission Regulation (EC) No 2073/2005 ( 9 );

(v) the handling and disposal of animal by-products and of specified risk material;

(vi) the health and welfare of the animals.

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:

(a) act independently from the production staff of the slaughterhouse;

(b) have undergone appropriate training to carry out these tasks; and

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

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:

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

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

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

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

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

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

(g) criteria and conditions to determine, in relation to Pectinidae, marine gastropods and Holothuroidea, by way of derogation from paragraph 6, when production and relaying areas are not to be classified;

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

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

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

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

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:

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

(b) the conditions for the classification and monitoring of classified production and relaying areas for live bivalve molluscs;

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

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

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

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

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:

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

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

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

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:

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

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

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

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:

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

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

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

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:

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

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

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:

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

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

(i) official controls on journey logs to verify that the journey log is realistic and indicates compliance with Regulation (EC) No 1/2005; and

(ii) official controls to verify that the transporter indicated in the journey log has a valid transporter authorisation, certificate of approval for the means of transport for long journeys and certificates of competence for drivers and attendants;

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

(i) official controls on the fitness of the animals being transported and on the means of transport to verify compliance with Chapter II of Annex I to Regulation (EC) No 1/2005 and where applicable Chapter VI thereof;

(ii) official controls to verify that transporters comply with applicable international agreements and have valid transporter authorisations and certificates of competence for drivers and attendants; and

(iii) official controls to verify whether domestic equidae and domestic animals of bovine, ovine, caprine and porcine species have been or are to be transported over long journeys.

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:

(a) to the Member States that granted the authorisation to the transporter;

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

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

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:

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

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

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

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

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

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:

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

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

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:

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

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

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:

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

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

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

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:

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

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

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

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

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

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

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

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

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

Article 24

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Article 25

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

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

(a) specific requirements and additional content to that provided for in Article 110 to prepare the relevant parts of the MANCP provided for in Article 109(1), and specific additional content to the report provided for in Article 113;

(b) specific responsibilities and tasks for the European Union reference centres in addition to those provided for in Article 98;

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

(d) the methods to be used for sampling and for laboratory analyses and tests, excluding any rules involving the setting of thresholds.

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

Article 26

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

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

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

(b) ordering the operator to increase the frequency of own controls;

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

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

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

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

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

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

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

(b) specific reporting obligations of the delegated bodies.

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

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

Article 27

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

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

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

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

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

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







CHAPTER III

Delegation of certain tasks of the competent authorities

Article 28

Delegation by the competent authorities of certain official control tasks

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

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

Article 29

Conditions for delegating certain official control tasks to delegated bodies

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

(a) the delegation contains a precise description of those official control tasks that the delegated body may perform, and the conditions under which it may perform those tasks;

(b) the delegated body:

(i) has the expertise, equipment and infrastructure required to perform those official control tasks delegated to it;

(ii) has a sufficient number of suitably qualified and experienced staff;

(iii) is impartial and free from any conflict of interest and in particular is not in a situation which may, directly or indirectly, affect the impartiality of its professional conduct as regards the performance of those official control tasks delegated to it;

(iv) works and is accredited in accordance with standards relevant to the delegated tasks in question, including standard EN ISO/IEC 17020 ‘Requirements for the operation of various types of bodies performing inspection’;

(v) has sufficient powers to perform the official control tasks delegated to it; and

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

Article 30

Conditions for delegating certain official control tasks to natural persons

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

(a) the delegation contains a precise description of those official control tasks that the natural persons may perform and the conditions under which the natural persons may perform those tasks;

(b) the natural persons:

(i) have the expertise, equipment and infrastructure required to perform those official control tasks delegated to them;

(ii) are suitably qualified and experienced;

(iii) act impartially and are free from any conflict of interest as regards the exercise of those official control tasks delegated to them; and

(c) there are arrangements in place ensuring efficient and effective coordination between the delegating competent authorities and the natural persons.

Article 31

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:

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

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

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

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

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

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

Article 32

Obligations of the delegated bodies and natural persons

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

(a) communicate the outcome of the official controls and other official activities performed by them to the delegating competent authorities on a regular basis and whenever those competent authorities so request;

(b) immediately inform the delegating competent authorities whenever the outcome of the official controls indicate non-compliance or point to the likelihood of non-compliance, unless specific arrangements established between the competent authority and the delegated body or the natural person concerned provides otherwise; and

(c) give competent authorities access to their premises and facilities and cooperate and provide assistance.

Article 33

Obligations of the delegating competent authorities

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

(a) organise audits or inspections of such bodies or persons, as necessary and avoiding duplication, taking into account any accreditation referred to in point (b)(iv) of Article 29;

(b) fully or partly withdraw the delegation without delay where:

(i) there is evidence that such a delegated body or natural person is failing to properly perform the tasks delegated to it;

(ii) the delegated body or the natural person fails to take appropriate and timely action to remedy the shortcomings identified; or

(iii) the independence or impartiality of the delegated body or natural person has been shown to be compromised.

This point shall be without prejudice to the competence of the competent authorities to withdraw the delegation for reasons other than those referred to in this Regulation.







CHAPTER IV

Sampling, analyses, tests and diagnoses

Article 34

Methods used for sampling, analyses, tests and diagnoses

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

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

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

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

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

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

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

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

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

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

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

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

(c) the interpretation of analytical, testing and diagnostic results.

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

Article 35

Second expert opinion

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

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

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

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

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

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

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

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

Article 36

Sampling of animals and goods offered for sale by means of distance communication

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

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

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

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

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

Article 37

Designation of official laboratories

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

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

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

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

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

(a) the tasks that the laboratory carries out as an official laboratory;

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

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

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

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

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

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

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

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

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

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

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

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

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

Article 38

Obligations of official laboratories

1. Where the results of an analysis, test or diagnosis carried out on samples taken during official controls or other official activities indicate a risk to human, animal or plant health, or, as regards GMOs and plant protection products, also to the environment, or point to the likelihood of non-compliance, official laboratories shall inform immediately the competent authorities which designated them for that analysis, test or diagnosis and, where relevant, delegated bodies or natural person