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

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.

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.

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) Regulation (EU) 2019/6 of the European Parliament and of the Council (²); however, this Regulation shall apply to official controls for the verification of compliance with Article 118(1) of that Regulation.

Article 2

Official controls and other official activities

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.

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

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).

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

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;