Section I

Competent authorities shall perform official controls on all operators regularly, on a risk basis and with appropriate frequency, taking account of: identified risks associated with: animals and goods; the activities under the control of operators; the location of the activities or operations of operators; 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; 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; 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); 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 any information that might indicate non-compliance with the rules referred to in Article 1(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. 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: the rules referred to in Article 1(2); the applicable delegated and implementing acts adopted by the Commission in accordance with Articles 18 to 27. 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. 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. 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: available on the Union market, whether originating in the Member State where the official controls are performed or in another Member State; to be exported from the Union; or entering the Union. 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. To the extent necessary to ascertain compliance with the rules referred to in Article 1(2), competent authorities shall perform official controls on: animals and goods at any stage of production, processing, distribution and use; 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; 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. 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. 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. Competent authorities shall perform official controls with a high level of transparency and shall, at least once a year, make available to the public, including through publication on the internet, relevant information concerning the organisation and the performance of official controls. They shall also ensure the regular and timely publication of information on the following: the type, number and outcome of official controls; the type and number of cases of non-compliance detected; the type and number of cases where measures were taken by the competent authorities in accordance with Article 138; and 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). Competent authorities shall establish procedures to ensure that any inaccuracies in the information made available to the public are appropriately rectified. 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: the rating criteria are objective, transparent and publicly available; and appropriate arrangements are in place to ensure the fairness, consistency and transparency of the rating process. 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. Competent authorities shall have control verification procedures in place. Competent authorities shall: take corrective actions in all cases where the procedures provided for in paragraph 2 identify shortcomings; and update the documented procedures provided for in paragraph 1 as appropriate. Paragraphs 1, 2 and 3 shall also apply to delegated bodies and organic control authorities. 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 description of the purpose of the official controls; the control methods applied; the outcome of the official controls; and where appropriate, action that the competent authorities require the operator concerned to take as a result of their official controls. 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. 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: regularly informed of the level of compliance; and promptly informed of any case of non-compliance identified through the official controls. 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. Official control methods and techniques shall include the following as appropriate: an examination of the controls that operators have put in place and of the results obtained; an inspection of: equipment, means of transport, premises and other places under their control and their surroundings; 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; cleaning and maintenance products and processes; traceability, labelling, presentation, advertising and relevant packaging materials including materials intended to come into contact with food; controls on the hygiene conditions in the operators’ premises; 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); 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; interviews with operators and with their staff; the verification of measurements taken by the operator and other test results; sampling, analysis, diagnosis and tests; audits of operators; any other activity required to identify cases of non-compliance. 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: the equipment, means of transport, premises and other places under their control and their surroundings; their computerised information management systems; the animals and goods under their control; their documents and any other relevant information. 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. 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. 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). 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: their name and legal form; and the specific activities they carry out, including activities undertaken by means of distance communication, and the places under their control. 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.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-02 · Text as adopted (Official Journal); later amendments are not incorporated in this text.