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)Text with EEA relevance

TITLE I SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1 Subject matter and scope

This Regulation lays down rules for:

the performance of official controls and other official activities by the competent authorities of the Member States;
the financing of official controls;
the administrative assistance and cooperation between Member States in view of the correct application of the rules referred to in paragraph 2;
the performance of controls by the Commission in Member States and in third countries;
the adoption of conditions to be fulfilled with respect to animals and goods entering the Union from a third country;
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:

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;
deliberate release into the environment of Genetically Modified Organisms (GMOs) for the purpose of food and feed production;
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;
animal health requirements;
prevention and minimisation of risks to human and animal health arising from animal by-products and derived products;
welfare requirements for animals;
protective measures against pests of plants;
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;
organic production and labelling of organic products;
use and labelling of protected designations of origin, protected geographical indications and traditional specialities guaranteed.

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.

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

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

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

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:

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

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:

‘food law’ means food law as defined in point (1) of Article 3 of Regulation (EC) No 178/2002;
‘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;
‘competent authorities’ means:
1. 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);
2. any other authority to which that responsibility has been conferred;
3. where appropriate, the corresponding authorities of a third country;
‘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;
‘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;
‘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;
‘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;
‘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);
‘animals’ means animals as defined in point (1) of Article 4 of Regulation (EU) 2016/429;
‘animal disease’ means disease as defined in point (16) of Article 4 of Regulation (EU) 2016/429;
‘goods’ means all that is subject to one or more of the rules referred to in Article 1(2), excluding animals;
‘food’ means food as defined in Article 2 of Regulation (EC) No 178/2002;
‘feed’ means feed as defined in point (4) of Article 3 of Regulation (EC) No 178/2002;
‘animal by-products’ means animal by-products as defined in point (1) of Article 3 of Regulation (EC) No 1069/2009;
‘derived products’ means derived products as defined in point (2) of Article 3 of Regulation (EC) No 1069/2009;
‘plants’ means plants as defined in point (1) of Article 2 of Regulation (EU) 2016/2031;
‘pests of plants’ means pests as defined in Article 1(1) of Regulation (EU) 2016/2031;
‘plant protection products’ means plant protection products as referred to in Article 2(1) of Regulation (EC) No 1107/2009;
‘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⁾;
‘germinal products’ means germinal products as defined in point (28) of Article 4 of Regulation (EU) 2016/429;
‘plant products’ means plant products as defined in point (2) of Article 2 of Regulation (EU) 2016/2031;
‘other objects’ means other objects as defined in point (5) of Article 2 of Regulation (EU) 2016/2031;
‘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;
‘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;
‘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;
‘certifying officer’ means:
1. any official of the competent authorities authorised to sign official certificates by such authorities; or
2. 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);
‘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);
‘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);
‘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);
‘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;
‘rating’ means a classification of operators based on an assessment of their conformity with rating criteria;
‘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);
‘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);
‘specified risk material’ means specified risk material as defined in point (g) of Article 3(1) of Regulation (EC) No 999/2001;
‘long journey’ means a long journey as defined in point (m) of Article 2 of Regulation (EC) No 1/2005;
‘pesticide application equipment’ means pesticide application equipment as defined in point (4) of Article 3 of Directive 2009/128/EC;
‘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;
‘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);
‘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;
‘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;
‘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);
‘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;
‘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);
‘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;
1. 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
2. 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;
‘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⁾;
‘control by the customs authorities’ means customs controls as defined in point (3) of Article 5 of Regulation (EU) No 952/2013;
‘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;
‘journey log’ means the document set out in points 1 to 5 of Annex II to Regulation (EC) No 1/2005;
‘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;
‘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⁾;
‘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

Article 5 General obligations concerning the competent authorities and the organic control authorities

Article 6 Audits of the competent authorities

Article 7 Right of appeal

Article 8 Confidentiality obligations of the competent authorities

CHAPTER II Official controls

Section I General requirements

Article 9 General rules on official controls

Article 10 Operators, processes and activities subject to official controls

Article 11 Transparency of official controls

Article 12 Documented control procedures

Article 13 Written records of official controls

Article 14 Methods and techniques for official controls

Article 15 Obligations of operators

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

Article 16 Additional requirements

Article 17 Specific definitions

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

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

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

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

Article 22 Specific rules on official controls and for action taken by the competent authorities in relation to plant health

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

Article 24 Specific rules on official controls and for action taken by the competent authorities in relation to plant protection products

Article 25 Specific rules on official controls and other official activities for organic production and labelling of organic products

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

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

CHAPTER III Delegation of certain tasks of the competent authorities

Article 28 Delegation by the competent authorities of certain official control tasks

Article 29 Conditions for delegating certain official control tasks to delegated bodies

Article 30 Conditions for delegating certain official control tasks to natural persons

Article 31 Conditions for delegating certain tasks related to other official activities

Article 32 Obligations of the delegated bodies and natural persons

Article 33 Obligations of the delegating competent authorities

CHAPTER IV Sampling, analyses, tests and diagnoses

Article 34 Methods used for sampling, analyses, tests and diagnoses

Article 35 Second expert opinion

Article 36 Sampling of animals and goods offered for sale by means of distance communication

Article 37 Designation of official laboratories

Article 38 Obligations of official laboratories

Article 39 Audits of official laboratories

Article 40 Derogations from the condition for the mandatory accreditation for certain official laboratories

Article 41 Powers to adopt derogations from the condition for the mandatory accreditation of all the methods of laboratory analysis, test and diagnosis used by official laboratories

Article 42 Temporary derogations from the conditions of the mandatory accreditation for official laboratories

CHAPTER V Official controls on animals and goods entering the Union

Article 43 Official controls on animals and goods entering the Union

Section I Animals and goods other than those subject to official controls at border control posts under section II

Article 44 Official controls on animals and goods other than those subject to official controls at border control posts under Section II

Article 45 Types of official controls on animals and goods other than those subject to official controls at border control posts under Section II

Article 46 Samples taken on animals and goods other than those subject to official controls at border control posts under Section II

Section II Official controls at border control posts on animals and goods

Article 47 Animals and goods subject to official controls at border control posts

Article 48 Animals and goods exempted from official controls at border control posts

Article 49 Official controls at border control posts

Article 50 Certificates and documents accompanying consignments and split consignments

Article 51 Specific rules for official controls at border control posts

Article 52 Details of documentary checks, identity checks and physical checks

Article 53 Official controls not performed at border control posts

Article 54 Frequency of documentary checks, identity checks and physical checks

Article 55 Decisions on consignments

Article 56 Use of the Common Health Entry Document (CHED) by the operator and by the competent authorities

Article 57 Use of the CHED by customs authorities

Article 58 Format, time requirements and specific rules for the use of the CHED

Article 59 Designation of border control posts

Article 60 Listing of border control posts

Article 61 Withdrawal of approvals for, and re-designation of, existing border control entities

Article 62 Withdrawal of the designation of border control posts

Article 63 Suspension of the designation of border control posts

Article 64 Minimum requirements for border control posts

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

Article 65 Suspicion of non-compliance and intensified official controls

Article 66 Measures to be taken in cases of non-compliant consignments entering the Union

Article 67 Measures to be taken on animals or goods entering the Union from third countries presenting a risk

Article 68 Follow-up of decisions taken in relation to non-compliant consignments entering the Union from third countries

Article 69 Failure by the operator to apply the measures ordered by the competent authorities

Article 70 Consistency of application of Articles 66, 67 and 68

Article 71 Special treatment of consignments

Article 72 Re-dispatch of consignments

Section IV Approval of the pre-export controls

Article 73 Approval of pre-export controls performed by third countries

Article 74 Non-compliance with, and withdrawal of, the approval of pre-export controls performed by third countries

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

Article 75 Cooperation between authorities in relation to consignments entering the Union from third countries

Article 76 Cooperation between authorities in relation to consignments not subject to specific controls at borders

Section VI Specific measures

Article 77 Rules for specific official controls and for measures to be taken following the performance of such controls

CHAPTER VI Financing of official controls and of other official activities

Article 78 General rules

Article 79 Mandatory fees or charges

Article 80 Other fees or charges

Article 81 Costs

Article 82 Calculation of fees or charges

Article 83 Collection and application of fees or charges

Article 84 Payment of fees or charges

Article 85 Transparency

CHAPTER VII Official certification

Article 86 General requirements concerning official certification

Article 87 Official certificates

Article 88 Signature and issuance of official certificates

Article 89 Guarantees of reliability for official certificates

Article 90 Implementing powers concerning official certificates

Article 91 Official attestations

TITLE III REFERENCE LABORATORIES AND REFERENCE CENTRES

Article 92 Decision to establish a European Union reference laboratory

Article 93 Designation of European Union reference laboratories

Article 94 Responsibilities and tasks of European Union reference laboratories

Article 95 Designation of European Union reference centres for animal welfare

Article 96 Responsibilities and tasks of European Union reference centres for animal welfare

Article 97 Designation of European Union reference centres for the authenticity and integrity of the agri-food chain

Article 98 Responsibilities and tasks of European Union reference centres for the authenticity and integrity of the agri-food chain

Article 99 Obligations of the Commission

Article 100 Designation of national reference laboratories

Article 101 Responsibilities and tasks of national reference laboratories

TITLE IV ADMINISTRATIVE ASSISTANCE AND COOPERATION

Article 102 General rules

Article 103 Liaison bodies

Article 104 Assistance on request

Article 105 Assistance without request in the event of non-compliance

Article 106 Assistance in the event of non-compliance creating a risk or a repeated or potentially serious infringement

Article 107 Assistance on the basis of information provided by third countries

Article 108 Coordinated assistance and follow-up by the Commission

TITLE V PLANNING AND REPORTING

Article 109 Multi-annual national control plans (MANCP) and a single body for the MANCP

Article 110 Content of the MANCPs

Article 111 Preparation, update and review of MANCPs

Article 112 Coordinated control programmes and information and data collection

Article 113 Annual reports by the Member States

Article 114 Annual reports by the Commission

Article 115 Contingency plans for food and feed

TITLE VI UNION ACTIVITIES

CHAPTER I Commission controls

Article 116 Commission controls in Member States

Article 117 Reports by the Commission on controls in Member States

Article 118 Programme of the Commission controls in Member States

Article 119 Obligations of the Member States as regards Commission controls

Article 120 Commission controls in third countries

Article 121 Frequency of Commission controls in third countries

Article 122 Reports by the Commission on controls in third countries

Article 123 Programme of the Commission controls in third countries

Article 124 Third-country controls in Member States

CHAPTER II Conditions for the entry into the Union of animals and goods

Article 125 Information on third countries' control systems

Article 126 Establishment of additional conditions for entry into the Union of animals and goods

Article 127 Inclusion in the list of third countries referred to in point (a) of Article 126(2)

Article 128 Special measures regarding the entry into the Union of certain animals and goods

Article 129 Equivalence

CHAPTER III Training of staff of the competent authorities and of other authorities

Article 130 Training and exchange of staff

CHAPTER IV Information management system

Article 131 Information management system for official controls (IMSOC)

Article 132 General functionalities of the IMSOC

Article 133 Use of the IMSOC in the case of animals and goods subject to certain official controls

Article 134 The functioning of the IMSOC

Article 135 Data protection

Article 136 Data security

TITLE VII ENFORCEMENT ACTION

CHAPTER I Actions by the competent authorities and penalties

Article 137 General obligations of the competent authorities as regards enforcement action

Article 138 Actions in the event of established non-compliance

Article 139 Penalties

Article 140 Reporting of infringements

CHAPTER II Union enforcement measures

Article 141 Serious disruption in a Member State's control system

TITLE VIII COMMON PROVISIONS

CHAPTER I Procedural provisions

Article 142 Amendment of Annexes and references to European standards

Article 143 Data protection

Article 144 Exercise of the delegation

Article 145 Committee procedure

CHAPTER II Transitional and final provisions

Article 146 Repeals

Article 147 Relation with Regulation (EC) No 882/2004

Article 148 Relation with Regulations (EC) No 852/2004 and (EC) No 853/2004 regarding approval of food business establishments

Article 149 Transitional measures related to the repeals of Directives 91/496/EEC and 97/78/EC

Article 150 Transitional measures related to the repeal of Directive 96/23/EC

Article 151 Amendments to Directive 98/58/EC

Article 152 Amendments to Directive 1999/74/EC

Article 153 Amendments to Regulation (EC) No 999/2001

Article 154 Amendments to Regulation (EC) No 1/2005 and related transitional measures

Article 155 Amendments to Regulation (EC) No 396/2005 and related transitional measures

Article 156 Amendments to Directive 2007/43/EC

Article 157 Amendments to Directive 2008/119/EC

Article 158 Amendments to Directive 2008/120/EC

Article 159 Amendments to Regulation (EC) No 1099/2009

Article 160 Amendments to Regulation (EC) No 1069/2009

Article 161 Amendments to Regulation (EC) No 1107/2009

Article 162 Amendments to Regulation (EU) No 1151/2012

Article 163 Amendments to Regulation (EU) No 652/2014

Article 164 Amendments to Regulation (EU) 2016/429 and related transitional provisions

Article 165 Amendments to Regulation (EU) 2016/2031 and related transitional provisions

Article 166 Transitional measures for the adoption of delegated and implementing acts

Article 167 Entry into force and application

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

ANNEX IITRAINING OF STAFF OF THE COMPETENT AUTHORITIES

ANNEX IIICHARACTERISATION OF METHODS OF ANALYSIS

ANNEX IV

ANNEX VCORRELATION TABLES REFERRED TO IN ARTICLE 146(2)