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Document 02017R0625-20211028
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
Consolidated text: 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
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
02017R0625 — EN — 28.10.2021 — 002.001
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REGULATION (EU) 2017/625 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 095 7.4.2017, p. 1) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION DELEGATED REGULATION (EU) 2019/478 of 14 January 2019 |
L 82 |
4 |
25.3.2019 |
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COMMISSION DELEGATED REGULATION (EU) 2019/2127 of 10 October 2019 |
L 321 |
111 |
12.12.2019 |
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REGULATION (EU) 2021/1756 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 October 2021 |
L 357 |
27 |
8.10.2021 |
Corrected by:
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:
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 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 );
Directive 2001/82/EC of the European Parliament and of the Council ( 2 ).
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.
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:
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);
any other authority to which that responsibility has been conferred;
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:
any official of the competent authorities authorised to sign official certificates by such authorities; or
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;
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
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
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:
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
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:
the competent authorities designated in accordance with paragraph 1;
the single authorities designated in accordance with point (b) of paragraph 2;
the organic control authorities referred to in paragraph 3;
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:
have procedures and/or arrangements in place to ensure the effectiveness and appropriateness of official controls and other official activities;
have procedures and/or arrangements in place to ensure the impartiality, quality and consistency of official controls and other official activities at all levels;
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;
have, or have access to, an adequate laboratory capacity for analysis, testing and diagnosis;
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;
have appropriate and properly maintained facilities and equipment to ensure that staff can perform official controls and other official activities efficiently and effectively;
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);
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;
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).
Staff performing official controls and other official activities shall:
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;
keep up-to-date in their area of competence and receive regular additional training as necessary; and
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).
Article 6
Audits of the competent authorities
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
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.
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:
the purpose of inspections, investigations or audits;
the protection of commercial interests of an operator or any other natural or legal person; or
the protection of court proceedings and legal advice.
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:
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
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
Article 9
General rules on official controls
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).
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.
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.
Article 10
Operators, processes and activities subject to official controls
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.
Article 11
Transparency 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 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.
Article 12
Documented control 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:
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.
Article 13
Written records of official controls
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.
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.
Article 14
Methods and techniques for official controls
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.
Article 15
Obligations of operators
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.
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.
Article 16
Additional requirements
When adopting delegated acts and implementing acts provided for in this Section, the Commission shall take into account the following:
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 );
scientific and technological developments;
consumer expectations with regard to food composition and changes in patterns of consumption of food;
risks to human and animal health and plant health associated with animals and goods; and
information on possible intentional violations perpetrated through fraudulent or deceptive practices.
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:
the need to facilitate the application of the delegated acts and implementing acts, taking into account the nature and the size of small businesses;
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
the needs of operators situated in regions that are subject to specific geographical constraints.
Article 17
Specific definitions
For the purpose of Article 18:
‘under the responsibility of the official veterinarian’ means that the official veterinarian assigns the performance of an action to an official auxiliary;
‘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;
‘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;
‘post-mortem inspection’ means the verification in the slaughterhouse or game-handling establishment of compliance with requirements applicable to:
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,
safe removal of specified risk material, and
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
The official controls referred to in paragraph 1 performed in relation to the production of meat shall include:
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;
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;
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;
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:
the hygiene of meat production;
the presence of residues of veterinary medicinal products and contaminants in products of animal origin intended for human consumption;
audits of good hygiene practices and procedures based on HACCP principles;
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 );
the handling and disposal of animal by-products and of specified risk material;
the health and welfare of the animals.
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:
act independently from the production staff of the slaughterhouse;
have undergone appropriate training to carry out these tasks; and
carry out these tasks in the presence and following the instructions of the official veterinarian or of the official auxiliary.
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:
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;
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;
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;
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;
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;
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;
criteria and conditions to determine, by way of derogation from paragraph 6, when production and relaying areas are not to be classified in relation to:
Pectinidae; and
where they are not filter feeders: echinoderms and marine gastropods;
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;
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;
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;
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.
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:
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;
the conditions for the classification and monitoring of classified production and relaying areas for live bivalve molluscs, echinoderms, tunicates and marine gastropods;
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);
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;
the technical requirements of the health mark and the practical arrangements for its application;
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).
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
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:
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;
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);
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.
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:
uniform minimum frequency of such official controls, having regard to the hazards and risks related to substances referred to in paragraph 1;
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);
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).
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
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:
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);
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);
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).
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:
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
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).
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
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:
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;
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:
official controls on journey logs to verify that the journey log is realistic and indicates compliance with Regulation (EC) No 1/2005; and
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;
at border control posts provided for in Article 59(1) and at exit points:
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;
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
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.
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.
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:
to the Member States that granted the authorisation to the transporter;
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;
where non-compliance with any such rule applicable to drivers is identified, to the Member State that issued the driver’s certificate of competence.
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:
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;
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);
the verification of animal welfare requirements at border control posts and at exit points and the minimum requirements applicable to those exit points;
specific criteria and conditions for the activation of the mechanisms of administrative assistance provided for in Articles 102 to 108;
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.
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:
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
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
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:
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
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).
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:
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;
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;
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).
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
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:
specific requirements for the performance of official controls to respond to recognised uniform hazards and risks of:
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;
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;
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).
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:
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;
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).
Article 24
Specific rules on official controls and for action taken by the competent authorities in relation to plant protection products
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:
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 );
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
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 ).
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:
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
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).
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:
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;
the collection of information, monitoring and reporting on suspected poisonings from plant protection products;
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).
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:
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;
specific responsibilities and tasks for the European Union reference centres in addition to those provided for in Article 98;
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;
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
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:
ordering that certain activities of the operator be subject to systematic or increased official controls;
ordering the operator to increase the frequency of own controls;
ordering the alteration of label in order to comply with the product specifications and the rules referred in point (j) of Article 1(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:
requirements, methods and techniques referred to in Articles 12 and 14 for official controls performed to verify compliance with product specifications and labelling requirements;
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;
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).
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:
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
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).
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
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:
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
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).
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
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:
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;
the delegated body:
has the expertise, equipment and infrastructure required to perform those official control tasks delegated to it;
has a sufficient number of suitably qualified and experienced staff;
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;
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’;
has sufficient powers to perform the official control tasks delegated to it; and
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:
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;
the natural persons:
have the expertise, equipment and infrastructure required to perform those official control tasks delegated to them;
are suitably qualified and experienced;
act impartially and are free from any conflict of interest as regards the exercise of those official control tasks delegated to them; and
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
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:
the rules referred to in Article 1(2) do not prohibit such delegation; and
the conditions laid down in Article 29 are fulfilled with the exception of that laid down in point (b)(iv).
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:
the rules referred to in Article 1(2) allow such delegation; and
the conditions laid down in Article 30, applied mutatis mutandis, are fulfilled.
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:
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;
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
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:
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;
fully or partly withdraw the delegation without delay where:
there is evidence that such a delegated body or natural person is failing to properly perform the tasks delegated to it;
the delegated body or the natural person fails to take appropriate and timely action to remedy the shortcomings identified; or
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
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:
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;
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.
The Commission may, by means of implementing acts, lay down rules on:
the methods to be used for sampling and for laboratory analyses, tests and diagnoses;
performance criteria, analysis, test or diagnosis parameters, measurement uncertainty and procedures for the validation of those methods;
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
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.
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:
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
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).
Article 36
Sampling of animals and goods offered for sale by means of distance communication
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:
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
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).
Article 37
Designation of official laboratories
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:
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
that laboratory is already designated as an official laboratory by the competent authorities of the Member State on whose territory it is located.
The designation of an official laboratory shall be in writing and shall include a detailed description of:
the tasks that the laboratory carries out as an official laboratory;
the conditions under which it carries out the tasks referred to in point (a); and
the arrangements necessary to ensure efficient and effective coordination and collaboration between the laboratory and the competent authorities.
The competent authorities may only designate as an official laboratory a laboratory which:
has the expertise, equipment and infrastructure required to carry out analyses or tests or diagnoses on samples;
has a sufficient number of suitably qualified, trained and experienced staff;
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;
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
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.
The scope of the accreditation of an official laboratory as referred to in point (e) of paragraph 4:
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;
may comprise one or more methods of laboratory analysis, test or diagnosis or groups of methods;
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.
Article 38
Obligations of official laboratories
Article 39
Audits of official laboratories
The competent authorities shall immediately withdraw the designation of an official laboratory, either completely or for certain tasks, where it fails to take appropriate and timely remedial action following the results of an audit provided for in paragraph 1 which disclose any of the following:
it no longer complies with the conditions provided for in Article 37(4) and (5);
it does not comply with the obligations provided for in Article 38;
it is underperforming at inter-laboratory comparative tests referred to in Article 38(2).
Article 40
Derogations from the condition for the mandatory accreditation for certain official laboratories
By way of derogation from point (e) of Article 37(4), competent authorities may designate the following as official laboratories irrespective of whether they fulfil the condition provided for in that point:
laboratories:
whose sole activity is the detection of Trichinella in meat;
that only use the methods of detection of Trichinella referred to in Article 6 of Commission Implementing Regulation (EU) 2015/1375 ( 13 );
that carry out the detection of Trichinella under the supervision of the competent authorities or of an official laboratory designated in accordance with Article 37(1) and accredited in accordance with the standard EN ISO/IEC 17025 for the use of the methods referred to in point (ii) of this point; and
that participate regularly and have satisfactory performance in the inter-laboratory comparative tests or proficiency tests organised by the national reference laboratories for the methods they use for the detection of Trichinella;
laboratories which only carry out analyses, tests or diagnoses in the context of other official activities, provided that they:
only use the methods of laboratory analysis, test and diagnosis referred to in Article 34(1) and point (a) or (b) of Article 34(2);
carry out the analyses, tests or diagnoses under the supervision of the competent authorities or of the national reference laboratories in relation to the methods they use;
participate regularly and have satisfactory performance in the inter-laboratory comparative tests or proficiency tests organised by the national reference laboratories in relation to the methods they use; and
have a quality assurance system in place to ensure sound and reliable results from the methods for laboratory analysis, test and diagnosis used.
Article 41
Powers to adopt derogations from the condition for the mandatory accreditation of all the methods of laboratory analysis, test and diagnosis used by official laboratories
The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the cases where, and the conditions under which, competent authorities may designate as official laboratories, in accordance with Article 37(1), laboratories which do not fulfil the conditions referred to in point (e) of Article 37(4) in relation to all the methods they use for official controls or other official activities, provided that such laboratories comply with the following conditions:
they operate and are accredited in accordance with the standard EN ISO/IEC 17025 for the use of one or more methods which are similar to and representative of the other methods they use; and
they make regular and significant use of the methods for which they have obtained the accreditation referred to in point (a) of this Article; except, as regards the area governed by the rules referred to in point (g) of Article 1(2), where a validated method for the detection of the particular pests of plants referred to in Article 34(1) and (2) does not exist.
Article 42
Temporary derogations from the conditions of the mandatory accreditation for official laboratories
By way of derogation from point (a) of Article 37(5), the competent authorities may temporarily designate an existing official laboratory as an official laboratory in accordance with Article 37(1) for the use of a method of laboratory analysis, test or diagnosis for which it has not obtained the accreditation referred to in point (e) of Article 37(4):
when the use of that method is newly required by Union rules;
when changes to a method in use require a new accreditation or an extension of the scope of the accreditation obtained by the official laboratory; or
in cases where the need for the use of the method results from an emergency situation or an emerging risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment.
The temporary designation referred to in paragraph 1 shall be subject to the following conditions:
the official laboratory is already accredited in accordance with the standard EN ISO/IEC 17025 for the use of a method which is similar to the one not included within the scope of its accreditation;
a quality assurance system is in place in the official laboratory to ensure sound and reliable results by using a method which is not included within the scope of the existing accreditation;
the analyses, tests or diagnoses are carried out under the supervision of the competent authorities or the national reference laboratory for that method.
CHAPTER V
Official controls on animals and goods entering the Union
Article 43
Official controls on animals and goods entering the Union
Official controls on animals and goods entering the Union shall be organised on a risk basis. In relation to animals and goods referred to in Articles 47 and 48, such official controls shall be performed in accordance with Articles 47 to 64.
Article 44
Official controls on animals and goods other than those subject to official controls at border control posts under Section II
On animals and goods referred to in paragraph 1 the appropriate frequency of the official controls shall be determined, taking into account:
the risks to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, associated with different types of animals and goods;
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 goods;
the history of compliance with the requirements established by the rules referred to in Article 1(2) applicable to the animals or goods concerned:
of the third country and establishment of origin or place of production, as appropriate;
of the exporter;
of the operator responsible for the consignment;
the controls that have already been performed on the animals and goods concerned; and
the guarantees that the competent authorities of the third country of origin have given with regard to compliance of the animals and goods with the requirements established by the rules referred to in Article 1(2) or with requirements recognised to be at least equivalent thereto.
The official controls provided for in paragraph 1 shall be performed at an appropriate place within the customs territory of the Union, including:
the point of entry into the Union;
a border control post;
the point of release for free circulation in the Union;
the warehouses and the premises of the operator responsible for the consignment;
the place of destination.
Notwithstanding paragraphs 1 and 3, the competent authorities at border control posts and other points of entry into the Union shall perform official controls on the following whenever they have reason to believe that their entry into the Union may pose a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment:
means of transport, including where empty; and
packaging, including pallets.
Article 45
Types of official controls on animals and goods other than those subject to official controls at border control posts under Section II
Where official controls are performed in accordance with Article 44(1), they shall:
always include a documentary check; and
include identity checks and physical checks depending on the risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment.
Article 46
Samples taken on animals and goods other than those subject to official controls at border control posts under Section II
Where samples on animals and goods are taken, the competent authorities shall, without prejudice to Articles 34 to 42:
inform the operators concerned and, where appropriate, the customs authorities; and
decide whether the animals or goods need to be detained pending the results of the analysis, test or diagnosis carried out, or whether they can be released provided that the traceability of the animals or goods is ensured.
The Commission shall, by means of implementing acts:
establish the procedures necessary to ensure the traceability of the animals or goods referred to in point (b) of paragraph 1; and
identify the documents that must accompany the animals or goods referred to in paragraph 1 when samples have been taken by the competent authorities.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 47
Animals and goods subject to official controls at border control posts
To ascertain compliance with the rules referred to in Article 1(2), the competent authorities shall perform official controls, at the border control post of first arrival into the Union, on each consignment of the following categories of animals and goods entering the Union:
animals;
products of animal origin, germinal products, animal by-products, hay and straw and foodstuffs containing both products of plant origin and processed products of animal origin (‘composite products’);
plants, plant products, and other objects as referred to in the lists established pursuant to Articles 72(1) and 74(1) of Regulation (EU) 2016/2031;
goods from certain third countries for which the Commission has decided, by means of implementing acts provided for in point (b) of paragraph 2 of this Article, that a measure requiring a temporary increase of official controls at their entry into the Union is necessary due to a known or emerging risk or because there is evidence that widespread serious non-compliance with the rules referred to in Article 1(2) might be taking place;
animals and goods which are subject to an emergency measure provided for in acts adopted in accordance with Article 53 of Regulation (EC) No 178/2002, Article 261 of Regulation (EU) 2016/429, or Articles 28(1), 30(1), 40(3), 41(3), 49(1), 53(3) and 54(3) of Regulation (EU) 2016/2031 requiring consignments of those animals or goods, identified by means of their codes from the Combined Nomenclature, to be subject to official controls at their entry into the Union;
animals and goods in relation to whose entry into the Union conditions or measures have been established by acts adopted in accordance with Article 126 or 128 respectively, or with the rules referred to in Article 1(2), which require that compliance with those conditions or measures be ascertained at the entry of the animals or goods into the Union.
The Commission shall, by means of implementing acts:
establish lists which set out all the animals and goods referred to in points (a) and (b) of paragraph 1, indicating their codes from the Combined Nomenclature; and
establish the list of goods belonging to the category referred to in point (d) of paragraph 1, indicating their codes from the Combined Nomenclature, and update it as necessary in relation to the risks referred to in that point.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 48
Animals and goods exempted from official controls at border control posts
The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning rules establishing the cases where, and the conditions under which, the following categories of animals and goods are exempted from Article 47, and when such exemption is justified:
goods sent as trade samples or as display items for exhibitions, which are not intended to be placed on the market;
animals and goods intended for scientific purposes;
goods on board means of transport operating internationally which are not unloaded and are intended for consumption by the crew and passengers;
goods which form part of passengers personal luggage and are intended for personal consumption or use;
small consignments of goods sent to natural persons which are not intended to be placed on the market;
pet animals as defined in point (11) of Article 4 of Regulation (EU) 2016/429;
goods which have undergone specific treatment and do not exceed quantities to be established in those delegated acts;
categories of animals or goods posing a low risk or no specific risk and for which controls at border control posts are therefore not necessary.
Article 49
Official controls at border control posts
Physical checks shall be performed where those checks concern:
animals, except aquatic animals, or meat and edible meat offal, by an official veterinarian, who may be assisted by staff trained in accordance with the requirements established under paragraph 5 in veterinary matters and designated by the competent authorities for that purpose;
aquatic animals, products of animal origin other than the ones referred to in point (a) of this paragraph, germinal products or animal by-products, by an official veterinarian or by staff trained in accordance with the requirements established under paragraph 5 and designated by the competent authorities for that purpose;
plants, plant products and other objects, by an official plant health officer.
Article 50
Certificates and documents accompanying consignments and split consignments
Article 51
Specific rules for official controls at border control posts
The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning rules to establish:
the cases where, and the conditions under which, the competent authorities of a border control post may authorise the onward transportation of consignments of the categories of animals and goods referred to in Article 47(1) to the place of final destination pending the availability of the results of physical checks, where such checks are required;
the time limits and arrangements for carrying out documentary checks and, where necessary, identity checks and physical checks on categories of animals and goods subject to the official controls provided for in Article 47(1) which enter the Union by sea or by air transport from a third country, when those animals or goods are moved from a vessel or aircraft and are transported under customs supervision to another vessel or aircraft in the same port or airport in preparation for onward travel (‘transhipped consignments’);
the cases where, and the conditions under which, identity checks and physical checks of transhipped consignments and of animals arriving by air or sea and staying on the same means of transport for onward travel may be performed at a border control post other than the one of first arrival into the Union;
the cases where, and the conditions under which, the transit of consignments of the categories of animals and goods referred to in Article 47(1) may be authorised and certain official controls to be performed at border control posts on such consignments, including the cases and conditions for the storage of goods in specially approved customs warehouses or in free zones;
the cases where, and the conditions under which, derogations from the rules on identity checks and physical checks shall apply as regards transhipped consignments and transit of consignments of the goods referred to in point (c) of Article 47(1).
Article 52
Details of documentary checks, identity checks and physical checks
For the purposes of ensuring the uniform implementation of Articles 49, 50 and 51, the Commission shall, by means of implementing acts, lay down detailed rules on the operations to be carried out during and after the documentary checks, identity checks and physical checks referred to in those Articles to ensure the efficient performance of those official controls. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 53
Official controls not performed at border control posts
The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning rules establishing the cases where and the conditions under which:
identity checks and physical checks on consignments of the categories of animals and goods referred to in Article 47(1) may be performed by competent authorities at control points other than border control posts provided that those control points comply with the requirements provided for in Article 64(3) and in the implementing acts adopted in accordance with Article 64(4);
physical checks on consignments which have undergone documentary checks and identity checks at a border control post of first arrival into the Union may be performed at another border control post in a different Member State;
identity checks and physical checks on consignments which have undergone documentary checks at a border control post of first arrival into the Union may be performed at another border control post in a different Member State;
specific control tasks may be performed by customs authorities or other public authorities, insofar as those tasks are not already falling under the responsibility of those authorities, on:
consignments referred to in Article 65(2);
passengers’ personal luggage;
goods ordered by sales through distance contracts, including by telephone or via the internet;
pet animals which meet the conditions laid down in Article 5 of Regulation (EU) No 576/2013 of the European Parliament and of the Council ( 14 );
documentary checks on consignments of plant, plant products and other objects referred to in point (c) of Article 47(1) may be performed at distance from a border control post.
Article 54
Frequency of documentary checks, identity checks and physical checks
The Commission shall, by means of implementing acts, lay down rules for the uniform application of the appropriate frequency rate referred to in paragraph 2. Those rules shall ensure that those frequencies are higher than a zero frequency and shall establish:
the criteria and the procedures for determining and modifying the frequency rates of identity checks and physical checks to be performed on consignments of the categories of animals and goods referred to in points (a), (b) and (c) of Article 47(1) and to adjust them to the level of risk associated with those categories, having regard to:
information collected by the Commission in accordance with Article 125(1);
the outcome of controls performed by Commission experts in accordance with Article 120(1);
operators’ past record as regards compliance with the rules referred to in Article 1(2);
data and information collected via the information management system for official controls (IMSOC) referred to in Article 131;
available scientific assessments; and
any other information regarding the risk associated to the categories of animals and goods;
the conditions under which Member States may increase the frequency rates of identity checks and physical checks established in accordance with point (a) so as to take account of local risk factors;
the procedures for ensuring that the frequency rates of identity checks and physical checks established in accordance with point (a) are applied in a timely and uniform manner.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
The Commission shall, by means of implementing acts, lay down rules on:
the frequency of identity checks and physical checks for the categories of goods referred to in point (d) of Article 47(1); and
the frequency of identity checks and physical checks for the categories of animals and goods referred to in points (e) and (f) of Article 47(1) as long as this is not already provided for in the acts referred to therein.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 55
Decisions on consignments
Decisions on consignments shall be taken by:
an official veterinarian where they concern animals, products of animal origin, germinal products or animal by-products; or
an official plant health officer where they concern plants, plant products and other objects.
Article 56
Use of the Common Health Entry Document (CHED) by the operator and by the competent authorities
The CHED shall be used by:
the operators responsible for consignments of the categories of animals and goods referred to in Article 47(1) in order to give prior notification to the competent authorities of the border control post of arrival of those consignments; and
the competent authorities of the border control post, in order to:
record the outcome of the official controls performed and any decisions taken on that basis, including the decision to reject a consignment;
communicate the information referred to in point (i) through the IMSOC.
The competent authorities of the border control post shall finalise the CHED as soon as:
all official controls required by Article 49(1) have been performed;
the results from physical checks, where such checks are required, are available; and
a decision on the consignment has been taken in accordance with Article 55 and recorded on the CHED.
Article 57
Use of the CHED by customs authorities
Customs authorities shall:
not allow the placing of the consignment under a customs procedure different from the one indicated by the competent authorities of the border control post; and
without prejudice to the exemptions referred to in Article 48 and the rules referred to in Articles 53 and 54, only allow the release for free circulation of a consignment upon presentation of a duly finalised CHED which confirms that the consignment is in compliance with the applicable rules referred to in Article 1(2).
Article 58
Format, time requirements and specific rules for the use of the CHED
The Commission shall, by means of implementing acts, lay down rules on:
the format of the CHED and the instructions for its presentation and use, taking into account relevant international standards; and
the minimum time requirements for prior notification of consignments by operators responsible for the consignment as provided for in point (a) of Article 56(3) in order to enable the competent authorities of the border control post to perform official controls in a timely and effective manner.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 59
Designation of border control posts
Within three months of receiving the notification referred to in paragraph 2, the Commission shall inform the Member State:
whether the designation of the proposed border control post is dependent upon the favourable outcome of a control performed by Commission experts in accordance with Article 116 in order to verify compliance with the minimum requirements laid down in Article 64; and
of the date of such a control, which is not to be later than six months from the notification.
Article 60
Listing of border control posts
Each Member State shall make available on the internet up-to-date lists of border control posts on its territory, providing the following information for each border control post:
its contact details;
its opening hours;
its exact location and whether it is a port, airport, rail or road entry point; and
the categories of animals and goods referred to in Article 47(1) which are included in the scope of its designation.
Article 61
Withdrawal of approvals for, and re-designation of, existing border control entities
Article 62
Withdrawal of the designation of border control posts
Where border control posts cease to comply with the requirements referred to in Article 64, the Member States shall:
withdraw the designation provided for in Article 59(1) for all or for certain categories of animals and goods for which the designation was made; and
remove those border control posts from the lists referred to in Article 60(1), for the categories of animals and goods for which the designation is withdrawn.
Article 63
Suspension of the designation of border control posts
Member States shall remove the suspension provided for in paragraph 1 as soon as:
the competent authorities are satisfied that the risk referred to in paragraph 1 no longer exists; and
they have communicated to the Commission and to the other Member States the information on the basis of which the suspension is removed.
Article 64
Minimum requirements for border control posts
Border control posts shall have:
a sufficient number of suitably qualified staff;
premises or other facilities appropriate to the nature and volume of the categories of animals and goods handled;
equipment and premises or other facilities to allow the performance of official controls for each of the categories of animals and goods for which the border control post has been designated;
arrangements in place to ensure, as appropriate, access to any other equipment, premise and service necessary to apply the measures taken in accordance with Articles 65, 66 and 67 in cases of suspicion of non-compliance, non-compliant consignments or consignments presenting a risk;
contingency arrangements to ensure the smooth operation of official controls and the effective application of the measures taken in accordance with Articles 65, 66 and 67 in cases of unforeseeable and unexpected conditions or events;
the technology and equipment necessary for the efficient operation of the IMSOC and, as appropriate, of other computerised information management systems necessary for the handling and exchange of data and information;
access to the services of official laboratories capable of providing analytical, testing and diagnostic results within appropriate deadlines and equipped with the information technology tools necessary to ensure the introduction of the results of analyses, tests or diagnoses carried out into the IMSOC as appropriate;
appropriate arrangements for the proper handling of different categories of animals and goods and to prevent risks which may result from cross-contamination; and
arrangements to comply with relevant biosecurity standards in order to prevent the spread of diseases into the Union.
Article 65
Suspicion of non-compliance and intensified official controls
Where appropriate, those consignments shall be isolated or quarantined and animals shall be sheltered, fed, watered and as necessary treated, pending the outcome of the official controls.
Article 66
Measures to be taken in cases of non-compliant consignments entering the Union
The competent authorities shall isolate or quarantine, as appropriate, any such consignment and the animals belonging to it shall be kept, cared for or treated under appropriate conditions pending any further decision. If possible, the competent authorities shall also take into account the interest of providing special care in respect of certain types of goods.
The competent authority shall, as regards the consignment referred to in paragraph 1 order, without delay, the operator responsible for the consignment to:
destroy the consignment;
re-dispatch the consignment outside the Union in accordance with Article 72(1) and (2); or
subject the consignment to special treatment in accordance with Article 71(1) and (2) or to any other measure necessary to ensure compliance with the rules referred to in Article 1(2), and, where appropriate, allocate the consignment for purposes other than those for which it was originally intended.
Any action referred to in points (a), (b) and (c) of the first subparagraph shall be performed in compliance with the rules referred to in Article 1(2), including in particular, as regards consignments of live animals, those intended to spare animals any avoidable pain, distress or suffering.
When the consignment consists of plants, plant products or other objects, points (a), (b) and (c) of the first subparagraph shall be applied either to the consignment or to lots thereof.
Before ordering the operator to take action in accordance with (a), (b) and (c) of the first subparagraph, the competent authority shall hear the operator concerned, unless immediate action is necessary in order to respond to a risk to human, animal or plant health, animal welfare or, as regards the GMOs and plant protection products, also to the environment.
Where the competent authority orders the operator to take one or more of the actions laid down in point (a), (b) or (c) of the first subparagraph of paragraph 3, that competent authority may exceptionally authorise the action to be taken in respect of a part of the consignment only, provided that the partial destruction, re-dispatch, special treatment, or other measure:
is such as to ensure compliance;
does not pose a risk to human, animal or plant health or to animal welfare or, as regards GMOs and plant protection products, also to the environment; and
does not disrupt official control operations.
The competent authorities shall immediately notify any decision to refuse entry of a consignment as provided for in paragraph 1 of this Article, and any order issued in accordance with paragraphs 3 and 6 of this Article and with Article 67 to:
the Commission;
the competent authorities of the other Member States;
the customs authorities;
the competent authorities of the third country of origin; and
the operator responsible for the consignment.
That notification shall be performed via the IMSOC.
Paragraphs 1, 3 and 5 of this Article shall apply to such consignments.
Article 67
Measures to be taken on animals or goods entering the Union from third countries presenting a risk
Where official controls indicate that a consignment of animals or goods presents a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, such consignment shall be isolated or quarantined and the animals belonging to it shall be kept, cared for or treated under appropriate conditions pending any further decision.
The competent authorities shall retain the consignment concerned under official detention and shall, without delay, order the operator responsible for that consignment to:
destroy the consignment in compliance with the rules referred to in Article 1(2), taking all the measures necessary to protect human, animal or plant health, animal welfare or the environment, and as regards live animals including in particular the rules on the sparing of any avoidable pain, distress or suffering; or
subject the consignment to special treatment in accordance with Article 71(1) and (2).
The measures referred to in this Article shall be applied at the expense of the operator responsible for the consignment.
Article 68
Follow-up of decisions taken in relation to non-compliant consignments entering the Union from third countries
The competent authorities shall:
invalidate the official certificates and as appropriate other relevant documents accompanying consignments which have been subject to measures pursuant to Article 66(3) and (6) and Article 67; and
cooperate in accordance with Articles 102 to 108 to take any further measures necessary to ensure that it is not possible to reintroduce consignments into the Union which have been refused entry in accordance with Article 66(1).
Where appropriate, such application shall be completed under the supervision of the competent authorities of another Member State.
Article 69
Failure by the operator to apply the measures ordered by the competent authorities
If, after the expiry of the period referred to in paragraph 1, no action has been taken by the operator concerned, the competent authorities shall order:
that the consignment be destroyed or subject to any other appropriate measure;
in the cases referred to in Article 67, that the consignment be destroyed in suitable facilities located as close as possible to the border control post, taking all measures necessary to protect human, animal or plant health, animal welfare or the environment.
Article 70
Consistency of application of Articles 66, 67 and 68
The Commission shall, by means of implementing acts, lay down rules to ensure consistency across all border control posts referred to in Article 59(1), and control points referred to in point (a) of Article 53(1), of decisions and measures taken and orders issued by the competent authorities in accordance with Articles 66, 67 and 68 which are to be followed by the competent authorities when responding to common or recurring situations of non-compliance or risk. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 71
Special treatment of consignments
The special treatment of consignments provided for in point (c) of Article 66(3) and point (b) of Article 67 may, as appropriate, include:
treatment or processing, including decontamination, where appropriate, but excluding dilution, so that the consignment complies with the requirements of the rules referred to in Article 1(2), or with the requirements of a third country of re-dispatch; or
treatment in any other manner suitable for safe animal or human consumption or for purposes other than animal or human consumption.
The special treatment provided for in paragraph 1 shall:
be carried out effectively and ensure the elimination of any risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment;
be documented and carried out under the control of the competent authorities or, where appropriate, under the control of the competent authorities of another Member State by mutual agreement; and
comply with the requirements laid down in the rules referred to in Article 1(2).
In the absence of rules adopted by delegated acts, such special treatment shall take place in accordance with national law.
Article 72
Re-dispatch of consignments
The competent authorities shall allow the re-dispatch of consignments subject to compliance with the following conditions:
the destination has been agreed with the operator responsible for the consignment;
the operator responsible for the consignment has informed the competent authorities of the Member State in writing that the competent authorities of the third country of origin or, if different, the third country of destination have been informed of the reasons and circumstances for the refusal of the entry into the Union of the consignment of animals or goods concerned;
where the third country of destination is not the third country of origin, the operator has obtained the agreement of the competent authorities of that third country of destination and those competent authorities have notified the competent authorities of the Member State that they are prepared to accept the consignment; and
in the case of consignments of animals, the re-dispatch is in compliance with animal welfare requirements.
Article 73
Approval of pre-export controls performed by third countries
The approval provided for in paragraph 1 shall specify:
the maximum frequency of official controls to be performed by the competent authorities of Member States at the entry of the consignments into the Union, where there is no reason to suspect non-compliance with the rules referred to in Article 1(2) or fraudulent or deceptive practices;
the official certificates that must accompany consignments entering the Union;
a model for the certificates referred to in point (b);
the competent authorities of the third country under the responsibility of which pre-export controls must be performed; and
where appropriate, any delegated body to which those competent authorities may delegate certain tasks. Such delegation may only be approved if it meets the criteria set out in Articles 28 to 33 or equivalent conditions.
The approval provided for in paragraph 1 of this Article may only be granted to a third country if the evidence available and, where appropriate, a Commission control performed in accordance with Article 120, demonstrate that the system of official controls in that third country is able to ensure that:
the consignments of the animals or goods exported to the Union meet the requirements of the rules referred to in Article 1(2), or equivalent requirements; and
the controls performed in the third country prior to dispatch to the Union are sufficiently effective to replace or reduce the frequency of the documentary, identity checks and physical checks laid down in the rules referred to in Article 1(2).
The competent authorities or a delegated body specified in the approval shall:
be responsible for contacts with the Union; and
ensure that the official certificates referred to in point (b) of paragraph 2 accompany each consignment that is controlled.
Article 74
Non-compliance with, and withdrawal of, the approval of pre-export controls performed by third countries
When official controls on consignments of categories of animal and goods in respect of which specific pre-export controls have been approved in accordance with Article 73(1) reveal serious and recurrent non-compliance with the rules referred to in Article 1(2), Member States shall immediately:
notify the Commission and the other Member States and operators concerned via the IMSOC in addition to seeking administrative assistance in accordance with the procedures established in Articles 102 to 108; and
increase the number of official controls on consignments from the relevant third country and, where necessary to allow a proper analytical examination of the situation, keep an appropriate number of samples under appropriate storage conditions.
Article 75
Cooperation between authorities in relation to consignments entering the Union from third countries
For that purpose, competent authorities, customs authorities and other authorities shall:
ensure reciprocal access to information which is necessary for the organisation and conduct of their respective activities in relation to animals and goods entering the Union; and
ensure the timely exchange of such information, including via electronic means.
The Commission shall, by means of implementing acts, lay down rules on uniform cooperation arrangements that competent authorities, customs authorities and other authorities referred to in paragraph 1 are required to put in place to ensure:
access by competent authorities to the information necessary for the immediate and complete identification of the consignments of animals and goods entering the Union that are subject to official controls at a border control post in accordance with Article 47(1);
the reciprocal update, through exchanges of information or synchronisation of relevant data sets, of information gathered by competent authorities, customs authorities and other authorities on consignments of animals and goods entering the Union; and
the swift communication of decisions taken by such authorities on the basis of the information referred to in points (a) and (b).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 76
Cooperation between authorities in relation to consignments not subject to specific controls at borders
Where the competent authorities consider that a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, is present;
they shall request the customs authorities not to release the consignment for free circulation and to include the following statement on the commercial invoice accompanying the consignment and on any other relevant accompanying document or the relevant electronic equivalents:
‘Product presents a risk — release for free circulation not authorised — Regulation ►C1 (EU) 2017/625 ◄ ’;
no other customs procedure shall be permitted without the consent of the competent authorities; and
Article 66(1), (3), (5) and (6), Articles 67, 68 and 69, Article 71(1) and (2) and Article 72(1) and (2) shall apply.
Article 77
Rules for specific official controls and for measures to be taken following the performance of such controls
The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning rules for the performance of specific official controls and on measures in cases of non-compliance, to account for the specificities of the following categories of animals and goods or the arrangements for, and means of, their transport:
consignments of fresh fishery products directly landed in ports designated by Member States in accordance with Article 5(1) of Council Regulation (EC) No 1005/2008 ( 16 ) from a fishing vessel flying a third country flag;
consignments of unskinned, furred wild game;
consignments of the categories of goods referred to in point (b) of Article 47(1) which are delivered, with or without storage in a specially approved customs warehouses or in free zones, to vessels leaving the Union and intended for ship supply or consumption by the crew and passengers;
wood packaging material;
feed accompanying animals and intended for the feeding of those animals;
animals and goods ordered by sales through distance contracts and delivered from a third country to an address in the Union, and the notification requirements necessary to allow the proper performance of official controls;
plant products which, on account of their subsequent destination, may give rise to the risk of spreading infectious or contagious animal diseases;
consignments of the categories of animals and goods referred to in points (a), (b) and (c) of Article 47(1) originating from, and returning to, the Union following a refusal of entry by a third country;
goods entering the Union in bulk from a third country, irrespective of whether they all originate from that third country;
consignments of goods referred to in Article 47(1) coming from the territory of Croatia and transiting through the territory of Bosnia and Herzegovina at Neum (‘Neum corridor’) before re-entering the territory of Croatia via the points of entry at Klek or Zaton Doli;
animals and goods exempted from Article 47 in accordance with Article 48.
The Commission may, by means of implementing acts, lay down rules on:
model official certificates and rules for the issuance of such certificates; and
the format of documents that must accompany the categories of animals or goods referred to in paragraph 1.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
CHAPTER VI
Financing of official controls and of other official activities
Article 78
General rules
Article 79
Mandatory fees or charges
The competent authorities shall collect fees or charges for the official controls performed in relation to the activities referred to in Chapter II of Annex IV and on animals and goods referred to in points (a), (b) and (c) of Article 47(1), at border control posts or at control points referred to in point (a) of Article 53(1), either;
at the level of the cost calculated in accordance with Article 82(1); or
at the amounts provided for in Annex IV.
The competent authorities shall collect fees or charges to recover the costs they incur in relation to:
official controls performed on animals and goods referred to in points (d), (e) and (f) of Article 47(1);
official controls performed at the request of the operator, to obtain the approval provided for in Article 10 of Regulation (EC) No 183/2005;
official controls which were not originally planned, and which;
have become necessary following the detection of a case of non-compliance by the same operator, during an official control performed in accordance with this Regulation; and
are performed to assess the extent and the impact of the case of non-compliance or to verify that the non-compliance has been remedied.
Notwithstanding paragraphs 1 and 2, Member States may, in relation to the activities referred to in Chapter II of Annex IV, on an objective and non-discriminatory basis, reduce the amount of the fees or charges, taking into account:
the interests of operators with a low throughput;
the traditional methods used for production, processing and distribution;
the needs of operators located in regions subject to specific geographical constraints; and
the operators’ record of compliance with the relevant rules referred to in Article 1(2) as ascertained through official controls.
Article 80
Other fees or charges
Member States may collect fees or charges to cover the costs of official controls and other official activities other than those fees or charges referred to in Article 79, unless prohibited by the legislative provisions applicable in the areas governed by the rules referred to in Article 1(2).
Article 81
Costs
The fees or charges to be collected in accordance with point (a) of Article 79(1) and with Article 79(2) shall be determined on the basis of the following costs, insofar as these result from the official controls concerned:
the salaries of the staff, including support and administrative staff, involved in the performance of official controls, their social security, pension and insurance costs;
the cost of facilities and equipment, including maintenance and insurance costs and other associated costs;
the cost of consumables and tools;
the cost of services charged to the competent authorities by delegated bodies for official controls delegated to these delegated bodies;
the cost of training of the staff referred to in point (a), with the exclusion of the training necessary to obtain the qualification necessary to be employed by the competent authorities;
the cost of travel of the staff referred to in point (a), and associated subsistence costs;
the cost of sampling and of laboratory analysis, testing and diagnosis charged by official laboratories for those tasks.
Article 82
Calculation of fees or charges
Fees or charges collected in accordance with point (a) of Article 79(1) and with Article 79(2) shall be established in accordance with one of the following methods of calculation or a combination of them:
at a flat-rate on the basis of the overall costs of official controls borne by the competent authorities over a given period of time, and applied to all operators irrespective of whether any official control is performed during the reference period in relation to each operator charged; in establishing the level of the fees to be charged for each sector, activity and category of operators, the competent authorities shall take into consideration the impact that the type and the size of the activity concerned, and the relevant risk factors, have on the distribution of the overall costs of those official controls; or
on the basis of the calculation of the actual costs of each individual official control, and applied to the operators subject to such official control.
Article 83
Collection and application of fees or charges
Article 84
Payment of fees or charges
Article 85
Transparency
Member States shall ensure a high level of transparency on:
the fees or charges provided for in point (a) of Article 79(1), Article 79(2) and Article 80, namely on:
the method and data used to establish these fees or charges;
the amount of the fees or charges, applied to each category of operators and for each category of official controls or other official activities;
the breakdown of the costs, as referred to in Article 81;
the identity of the authorities or bodies responsible for the collection of the fees or charges.
CHAPTER VII
Official certification
Article 86
General requirements concerning official certification
Official certification shall result in the issuance of:
official certificates; or
official attestations in the cases provided for in the rules referred to in Article 1(2).
Article 87
Official certificates
Articles 88, 89 and 90 shall apply:
when the rules referred to in Article 1(2) require the issuance of an official certificate; and
to official certificates which are necessary for the purposes of exporting consignments of animals and goods to third countries or which are requested from the competent authority of a Member State of dispatch by the competent authority of a Member State of destination in respect of consignments of animals and goods which are to be exported to third countries.
Article 88
Signature and issuance of official certificates
Competent authorities shall designate the certifying officers who are authorised to sign official certificates and shall ensure that these officers:
are impartial, free from any conflict of interest, and in particular are not in a situation which may, directly or indirectly, affect the impartiality of their professional conduct in relation to what is being certified; and
have received appropriate training on the rules with which compliance is certified by an official certificate and on the technical assessment of compliance with those rules as well as with the relevant rules laid down in this Regulation.
Official certificates shall be signed by the certifying officer and issued on one of the following grounds:
direct knowledge by the certifying officer of up-to-date facts and data relevant for the certification that is obtained through:
an official control; or
the acquisition of another official certificate issued by the competent authorities;
facts and data relevant for the certification, knowledge of which was ascertained by another person authorised for that purpose by, and acting under the control of, the competent authorities, provided that the certifying officer can verify the accuracy of such facts and data;
facts and data relevant for the certification which were obtained from the operators’ own control systems, complemented and confirmed by results from regular official controls, where the certifying officer is thus satisfied that the conditions for issuing the official certificate are met.
Article 89
Guarantees of reliability for official certificates
Official certificates shall:
bear a unique code;
not be signed by the certifying officer where they are blank or incomplete;
be drawn up in one or more of the official languages of the institutions of the Union understood by the certifying officer and, where relevant, in one of the official languages of the Member State of destination;
be authentic and accurate;
allow for the identification of the person who signed them and the date of issue; and
allow the easy verification of the links between the certificate, the issuing authority and the consignment, lot or individual animal or good covered by the certificate.
Article 90
Implementing powers concerning official certificates
The Commission may, by means of implementing acts, lay down rules for the uniform application of Articles 88 and 89 concerning:
model official certificates and rules for the issuance of such certificates, where requirements are not laid down in the rules referred to in Article 1(2);
the mechanisms and technical arrangements to ensure the issuance of accurate and reliable official certificates, and prevent risk of fraud;
the procedures to be followed in the case of withdrawals of official certificates and for the issuance of replacement certificates;
rules for the production of certified copies of official certificates;
the format of documents that must accompany animals and goods after official controls have been performed;
rules for the issuance of electronic certificates and for the use of electronic signatures.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 91
Official attestations
Official attestations shall:
be authentic and accurate;
be drawn up in one or more of the official languages of the institutions of the Union and, where relevant, in one of the official languages of the Member State of destination; and
where they relate to a consignment or a lot, allow the verification of the link between the official attestation and that consignment or lot.
Competent authorities shall ensure that the staff performing official controls to supervise the issuance of official attestations or, where the official attestations are issued by the competent authorities, the staff involved in the issuance of those official attestations:
are impartial, free from any conflict of interest, and in particular are not in a situation which may, directly or indirectly, affect the impartiality of their professional conduct in relation to what is being certified by the official attestations; and
have received appropriate training on:
the rules with which compliance is certified by the official attestations and on the technical assessment of compliance with those rules;
the relevant rules laid down in this Regulation.
Competent authorities shall perform regular official controls to verify that:
the operators issuing the attestations comply with the conditions laid down in the rules referred to in Article 1(2); and
the attestation is issued on the basis of relevant, correct and verifiable facts and data.
TITLE III
REFERENCE LABORATORIES AND REFERENCE CENTRES
Article 92
Decision to establish a European Union reference laboratory
In the areas governed by the rules referred to in Article 1(2), a European Union reference laboratory shall be established where the effectiveness of official controls and other official activities also depends on the quality, uniformity and reliability of:
the methods of analysis, test or diagnosis employed by the official laboratories designated in accordance with Article 37(1); and
the results of the analyses, tests and diagnoses performed by those official laboratories.
Article 93
Designation of European Union reference laboratories
The designations provided for in paragraph 1 shall:
follow a public selection process; and
be limited in time and with a minimum period of five years, or reviewed regularly.
European Union reference laboratories shall:
operate in accordance with standard EN ISO/IEC 17025 and be accredited in accordance with that standard by a national accreditation body, operating in accordance with Regulation (EC) No 765/2008. The scope of that accreditation:
shall include all the methods of laboratory analysis, test or diagnosis required to be used by the laboratory when it operates as a European Union reference laboratory;
may comprise one or more methods of laboratory analysis, test or diagnosis or groups of methods;
may be defined in a flexible manner, so as to allow the scope of the accreditation to include modified versions of the methods used by the European Union reference 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, prior to the use of those modified or new methods, by the national accreditation body of the Member State where the European Union reference laboratory is located;
be impartial, free from any conflict of interest, and in particular not be in a situation which may, directly or indirectly, affect the impartiality of their professional conduct as regards the exercise of their tasks as European Union reference laboratories;
have, or have contractual access to, suitably qualified staff with adequate training in analytical, testing and diagnostic techniques applied in their area of competence, and support staff as appropriate;
possess, or have access to, the infrastructure, equipment and products necessary to carry out the tasks assigned to them;
ensure that their staff and any contractually engaged staff have good knowledge of international standards and practices and that the latest developments in research at national, Union and international level are taken into account in their work;
be equipped, or have access to, the necessary equipment to perform their tasks in emergency situations; and
where relevant, be equipped to comply with relevant biosecurity standards.
By way of derogation from paragraphs 1 and 2 of this Article, the laboratories referred to in the first paragraph of Article 32 of Regulation (EC) No 1829/2003 and the first paragraph of the Article 21 of Regulation (EC) No 1831/2003 shall be the European Union reference laboratories having the responsibilities and performing the tasks referred to in Article 94 of this Regulation in the areas respectively of:
GMOs and genetically modified food and feed; and
feed additives.
Article 94
Responsibilities and tasks of European Union reference laboratories
European Union reference laboratories designated in accordance with Article 93(1) shall be responsible for the following tasks insofar as they are included in the reference laboratories’ annual or multiannual work programmes that have been established in conformity with the objectives and priorities of the relevant work programmes adopted by the Commission in accordance with Article 36 of Regulation (EU) No 652/2014:
providing national reference laboratories with details and guidance on the methods of laboratory analysis, testing or diagnosis, including reference methods;
providing reference materials to national reference laboratories;
coordinating the application by the national reference laboratories and, if necessary, by other official laboratories of the methods referred to in point (a), in particular, by organising regular inter-laboratory comparative testing or proficiency tests and by ensuring appropriate follow-up of such comparative testing or proficiency tests in accordance, where available, with internationally accepted protocols, and informing the Commission and the Member States of the results and follow-up to the inter-laboratory comparative testing or proficiency tests;
coordinating practical arrangements necessary to apply new methods of laboratory analysis, testing or diagnosis, and informing national reference laboratories of advances in this field;
conducting training courses for staff from national reference laboratories and, if needed, from other official laboratories, as well as of experts from third countries;
providing scientific and technical assistance to the Commission within the scope of their mission;
providing information on relevant national, Union and international research activities to national reference laboratories;
collaborating within the scope of their mission with laboratories in third countries and with the European Food Safety Authority (EFSA), the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC);
assisting actively in the diagnosis of outbreaks in Member States of foodborne, zoonotic or animal diseases, or of pests of plants, by carrying out confirmatory diagnosis, characterisation and taxonomic or epizootic studies on pathogen isolates or pest specimens;
coordinating or performing tests for the verification of the quality of reagents and lots of reagents used for the diagnosis of foodborne, zoonotic or animal diseases and pests of plants;
where relevant for their area of competence, establishing and maintaining:
reference collections of pests of plants and/or reference strains of pathogenic agents;
reference collections of materials intended to come into contact with food used to calibrate analytical equipment and provide samples thereof to national reference laboratories;
up-to-date lists of available reference substances and reagents and of manufacturers and suppliers of such substances and reagents; and
where relevant for their area of competence, cooperate among themselves and with the Commission, as appropriate, to develop methods of analysis, testing or diagnosis of high standards.
As regards point (i) of point (k), the European Union reference laboratory may establish and maintain those reference collections and reference strains by contractual outsourcing to other official laboratories and to scientific organisations.
Article 95
Designation of European Union reference centres for animal welfare
The designations provided for in paragraph 1 shall:
follow a public selection process; and
be limited in time or reviewed regularly.
European Union reference centres for animal welfare shall:
act impartially as regards the exercise of their tasks as European Union reference centres;
possess a high level of scientific and technical expertise in human-animal relationship, animal behaviour, animal physiology, animal genetics, animal health and nutrition related to animal welfare, and animal welfare aspects related to the commercial and scientific use of animals;
have suitably qualified staff with adequate training in the areas referred to in point (b) and in ethical issues related to animals and support staff as appropriate;
possess, or have access to, the infrastructure, the equipment and products necessary to carry out the tasks assigned to them; and
ensure that their staff have good knowledge of international standards and practices in the areas referred to in point (b) and that the latest developments in research at national, Union and international level, including studies performed and actions undertaken by other European Union reference centres for animal welfare, in those areas are taken into account in their work.
Article 96
Responsibilities and tasks of European Union reference centres for animal welfare
The European Union reference centres for animal welfare shall be responsible for the following supporting tasks insofar as they are included in the reference centres’ annual or multiannual work programmes that have been established in conformity with the objectives and priorities of the relevant work programmes adopted by the Commission in accordance with Article 36 of Regulation (EU) No 652/2014:
providing scientific and technical expertise within the scope of their mission including, where appropriate in the form of coordinated assistance, to relevant national support networks and bodies in the area governed by the rules referred to in point (f) of Article 1(2);
providing scientific and technical expertise for the development and application of the animal welfare indicators referred to in point (e) of Article 21(8);
developing or coordinating the development of methods for the assessment of the level of welfare of animals and of methods for the improvement of the welfare of animals;
carrying out scientific and technical studies on the welfare of animals used for commercial or scientific purposes;
conducting training courses for staff of the national scientific support networks or bodies referred to in point (a), for staff of the competent authorities and for experts from third countries; and
disseminating research findings and technical innovations and collaborating with Union research bodies in the fields within the scope of their mission.
Article 97
Designation of European Union reference centres for the authenticity and integrity of the agri-food chain
The designations provided for in paragraph 1 shall:
follow a public selection process; and
be limited in time or reviewed regularly.
European Union reference centres for the authenticity and integrity of the agri-food chain shall:
act impartially as regards the exercise of their tasks as European Union reference centres;
possess a high level of scientific and technical expertise in the areas governed by the rules referred to in Article 1(2) and in applied forensic science in those areas, in order to have the ability to carry out or coordinate research at the highest level on the authenticity and integrity of goods and to develop, apply and validate the methods to be used for the detection of violations of the rules referred to in Article 1(2) perpetrated through fraudulent or deceptive practices;
have suitably qualified staff with adequate training in the areas referred to in point (b) and the necessary support staff;
possess, or have access to, the infrastructure, the equipment and the products necessary to carry out the tasks assigned to them; and
ensure that their staff have good knowledge of international standards and practices in the areas referred to in point (b) and that the latest research developments at national, Union and international level in those areas are taken into account in their work.
Article 98
Responsibilities and tasks of European Union reference centres for the authenticity and integrity of the agri-food chain
The European Union reference centres for the authenticity and integrity of the agri-food chain shall be responsible for the following supporting tasks insofar as they are included in the reference centres’ annual or multiannual work programmes that have been established in conformity with the objectives and priorities of the relevant work programmes adopted by the Commission in accordance with Article 36 of Regulation (EU) No 652/2014:
providing specialised knowledge in relation to the authenticity and integrity of the agri-food chain and to the methods for detecting violations of the rules referred to in Article 1(2) of this Regulation perpetrated through fraudulent or deceptive practices, in relation to the forensic science applied to the areas governed by these rules;
providing specific analyses designed to identify the segments of the agri-food chain that are potentially subject to violations of the rules referred to in Article 1(2) of this Regulation perpetrated through fraudulent or deceptive practices and helping to develop specific official control techniques and protocols;
where necessary, performing the tasks referred to in points (a) to (h) of Article 94(2) of this Regulation, thereby avoiding duplication with the tasks of European Union reference laboratories designated in accordance with Article 93 of this Regulation;
where necessary, establishing and maintaining collections or databases of authenticated reference materials, to be used to detect violations of the rules referred to in Article 1(2) of this Regulation perpetrated through fraudulent or deceptive practices; and
disseminating research findings and technical innovations in the fields within the scope of their mission.
Article 99
Obligations of the Commission
The Commission shall publish and update, whenever necessary, the list of:
European Union reference laboratories provided for in Article 93;
European Union reference centres for animal welfare provided for in Article 95;
European Union reference centres for the authenticity and integrity of the agri-food chain provided for in Article 97.
If the Commission controls referred to in paragraph 3 of this Article show non-compliance with the requirements laid down in Article 93(3), Article 94, and Articles 95(3) and 97(3), the Commission shall, after having received the comments of the European Union reference laboratory or European Union reference centre:
by means of an implementing act, withdraw the designation of that laboratory or centre; or
take any other appropriate measure.
Article 100
Designation of national reference laboratories
Member States may designate a national reference laboratory also in the cases where there is no corresponding European Union reference laboratory.
A Member State may designate a laboratory situated in another Member State or in a third country that is a Contracting Party to the Agreement on the European Economic Area.
A single laboratory may be designated as a national reference laboratory for more than one Member State.
By way of derogation from point (e) of Article 37(4), for the area governed by the rules referred to in point (g) of Article 1(2), competent authorities may designate official laboratories, designated as such by the competent authorities on the basis of a derogation adopted under Article 41, as national reference laboratories irrespective of whether they fulfil the condition provided for in point (e) of Article 37(4).
National reference laboratories shall:
be impartial, free from any conflict of interests, and in particular not be in a situation which may, directly or indirectly, affect the impartiality of their professional conduct as regards the exercise of their tasks as national reference laboratories;
have, or have contractual access to, suitably qualified staff with adequate training in analytical, testing and diagnostic techniques in their area of competence, and support staff as appropriate;
possess, or have access to, the infrastructure, equipment and products needed to carry out the tasks assigned to them;
ensure that their staff and any contractually engaged staff have good knowledge of international standards and practices and that the latest developments in research at national, Union and international level are taken into account in their work;
be equipped with, or have access to, the necessary equipment to perform their tasks in emergency situations; and
where relevant, be equipped to comply with relevant biosecurity standards.
Member States shall:
communicate the name and address of each national reference laboratory to the Commission, the relevant European Union reference laboratory and other Member States;
make the information referred to in point (a) available to the public; and
update the information referred to in point (a) whenever necessary.
Article 101
Responsibilities and tasks of national reference laboratories
National reference laboratories shall, in their area of competence:
collaborate with the European Union reference laboratories, and participate in training courses and in inter-laboratory comparative tests organised by these laboratories;
coordinate the activities of official laboratories designated in accordance with Article 37(1) with a view of harmonising and improving the methods of laboratory analysis, test or diagnosis and their use;
where appropriate, organise inter-laboratory comparative testing or proficiency tests between official laboratories, ensure an appropriate follow-up of such tests and inform the competent authorities of the results of such tests and follow-up;
ensure the dissemination to the competent authorities and official laboratories of information that the European Union reference laboratory supplies;
provide within the scope of their mission scientific and technical assistance to the competent authorities for the implementation of MANCPs referred to in Article 109 and of coordinated control programmes adopted in accordance with Article 112;
where relevant, validate the reagents and lots of reagents, establish and maintain up-to-date lists of available reference substances and reagents and of manufacturers and suppliers of such substances and reagents;
where necessary, conduct training courses for the staff of official laboratories designated under Article 37(1); and
assist actively the Member State having designated them in the diagnosis of outbreaks of foodborne, zoonotic or animal diseases or of pests of plants and in case of non-compliance of consignments, by carrying out confirmatory diagnoses, characterisation and epizootic or taxonomic studies on pathogen isolates or pest specimens.
TITLE IV
ADMINISTRATIVE ASSISTANCE AND COOPERATION
Article 102
General rules
This Title shall be without prejudice to national law:
applicable to the release of documents and information that are the object of, or related to, judicial investigations and court proceedings, including criminal investigations; and
aimed at the protection of natural or legal persons’ commercial interests.
Member States shall take measures to facilitate the transmission, from other law enforcement authorities, public prosecutors and judicial authorities, to the competent authorities, of information on possible non-compliance with the rules referred to in Article 1(2) which is relevant for the application of this Title and which may constitute:
a risk to human, animal or plant health, or to animal welfare, or, as regards GMOs and plant protection products, also to the environment; or
a possible violation of the rules referred to in Article 1(2) perpetrated through fraudulent or deceptive practices.
In order to streamline and simplify communication exchanges, the Commission shall, by means of implementing acts, establish a standard format for:
the requests for assistance provided for in Article 104(1); and
the communication of common and recurrent notifications and responses.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 103
Liaison bodies
Article 104
Assistance on request
Where the competent authorities in a Member State consider that, for the performance of official controls or for the effective follow-up to such controls in their territory, they require data or information from the competent authorities of another Member State, they shall issue a reasoned request for administrative assistance to the competent authorities of that Member State. The requested competent authorities shall:
acknowledge receipt of the request without delay;
where the requesting competent authority so specifies, indicate within ten working days from the date of receipt of the request, the estimated time necessary to provide an informed response to the request; and
perform official controls or investigations necessary to provide the requesting competent authorities without delay with all necessary information and documents to enable them to take informed decisions and verify compliance with Union rules within their jurisdiction.
In such cases the staff of the requesting competent authorities shall:
at all times be able to produce written authority stating their identity and their official capacity;
be granted access by the operator to the same premises and documents as the staff of the requested competent authorities, through their intermediary, and for the sole purpose of the administrative enquiry being carried out; and
not, on their own initiative, exercise the powers of enquiry conferred on officials of the requested competent authorities.
Article 105
Assistance without request in the event of non-compliance
The competent authorities notified in accordance with paragraph 1 shall:
acknowledge receipt of the notification without undue delay;
where the notifying competent authority so specifies, indicate within ten working days from the date of receipt of the notification:
what investigations they intend to carry out; or
the reasons why they consider that no investigations are necessary; and
where investigations referred to in point (b) are considered necessary, investigate the matter and inform the notifying competent authorities without delay of the results and, where appropriate, of any measures taken.
Article 106
Assistance in the event of non-compliance creating a risk or a repeated or potentially serious infringement
The notified competent authorities shall without delay:
acknowledge receipt of the notification;
where the notifying competent authority so specifies, indicate what investigations they intend to carry out; and
investigate the matter, take all necessary measures and inform the notifying competent authorities of the nature of the investigations and official controls performed, of the decisions taken and of the reasons for such decisions.
If the notifying competent authorities have reason to believe that the investigations performed or the measures taken by the notified competent authorities do not adequately address the non-compliance established, they shall request the notified competent authorities to complement the official controls performed or the measures taken. In such cases the competent authorities from the two Member States shall:
seek an agreed approach with the aim of appropriately addressing the non-compliance, including through joint official controls and investigations performed in accordance with Article 104(3); and
inform the Commission without delay where they are not able to agree on appropriate measures.
Article 107
Assistance on the basis of information provided by third countries
When competent authorities receive information from a third country indicating non-compliance with rules referred to in Article 1(2) or a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, they shall, without delay:
notify such information to the competent authorities in other concerned Member States; and
communicate such information to the Commission where it is or may be relevant at Union level.
Information obtained through official controls and investigations performed in accordance with this Regulation may be communicated to the third country referred to in paragraph 1, provided that:
the competent authorities which have provided the information consent to such communication;
the third country has undertaken to provide the assistance necessary to gather evidence of practices that are or appear to be non-compliant with Union rules or that pose a risk to humans, animals or plants or the environment; and
relevant Union and national rules applicable to the communication of personal data to third countries are complied with.
Article 108
Coordinated assistance and follow-up by the Commission
Where the competent authorities in the Member States concerned are unable to agree on appropriate action to address the non-compliance with the rules referred to in Article 1(2), the Commission shall coordinate without delay the measures and actions undertaken by competent authorities in accordance with this Title where information available to the Commission either:
reports activities that are, or appear to be, non-compliant with the rules referred to in Article 1(2), and such activities have, or might have, ramifications in more than one Member State; or
indicates that the same, or similar, activities that are, or appear to be, non-compliant with the rules referred to in Article 1(2) might be taking place in more than one Member State.
In the cases referred to in paragraph 1, the Commission may:
in collaboration with the Member State concerned, send an inspection team to perform an on-the-spot official control;
request, by means of implementing acts, that the competent authorities in the Member State of dispatch and, where appropriate, in other Member States concerned, appropriately intensify official controls and report to it on the measures taken by them;
take any other appropriate measure in accordance with the rules referred to in Article 1(2).
TITLE V
PLANNING AND REPORTING
Article 109
Multi-annual national control plans (MANCP) and a single body for the MANCP
Member States shall designate a single body tasked with:
coordinating the preparation of the MANCP across all competent authorities responsible for the official controls;
ensuring that the MANCP is coherent;
collecting the information on the implementation of the MANCP in view of submitting the annual reporting referred to in Article 113 and of its review and update as necessary in accordance with Article 111(2).
Article 110
Content of the MANCPs
MANCPs shall contain general information on the structure and organisation of the systems of official control in the Member State concerned in each of the areas covered, and shall contain information on at least the following:
the strategic objectives of the MANCP and on how the prioritisation of official controls and allocation of resources reflect these objectives;
the risk categorisation of the official controls;
the designation of competent authorities and their tasks at central, regional and local level, and on resources available to those authorities;
where appropriate, the delegation of tasks to delegated bodies;
the general organisation and management of official controls at national, regional and local level, including official controls in individual establishments;
control systems applied to different sectors and coordination between the different services of competent authorities responsible for official controls in those sectors;
procedures and arrangements in place to ensure compliance with the obligations of the competent authorities provided for in Article 5(1);
the training of staff of the competent authorities;
the documented procedures provided for in Article 12(1);
the general organisation and operation of contingency plans in accordance with the rules referred to in Article 1(2); and
the general organisation of cooperation and mutual assistance between competent authorities in the Member States.
Article 111
Preparation, update and review of MANCPs
The MANCP shall be regularly updated to adjust it to changes to the rules referred to in Article 1(2), and reviewed to take account at least of the following factors:
the emergence of new diseases, pests of plants or other risks to human, animal or plant health, animal welfare or, in the case of GMOs and plant protection products, also to the environment;
significant changes to the structure, management or operation of the competent authorities in the Member State;
the outcome of Member States’ official controls;
the outcome of Commission controls performed in the Member State in accordance with Article 116(1);
scientific findings; and
the outcome of official controls performed by the competent authorities of a third country in a Member State.
Article 112
Coordinated control programmes and information and data collection
With a view to conducting Union-wide targeted assessment of the state of application of the rules referred to in Article 1(2) or establishing the prevalence of certain hazards across the Union, the Commission may adopt implementing acts concerning:
the implementation of coordinated control programmes of limited duration in one of the areas governed by the rules referred to in Article 1(2);
the organisation, on an ad hoc basis, of the collection of data and information in relation to the application of a specific set of the rules referred to in Article 1(2) or regarding the prevalence of certain hazards.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 113
Annual reports by the Member States
By 31 August every year, each Member State shall submit to the Commission a report setting out:
any amendments made to its MANCP to take account of the factors referred to in Article 111(2);
the outcome of official controls performed in the previous year under its MANCP;
the type and number of cases of non-compliance with the rules referred to in Article 1(2), per area, detected in the previous year by the competent authorities;
the measures taken to ensure the effective operation of its MANCP, including enforcement action and the results of such measures, and
a link to the web page of the competent authority containing the public information on fees or charges referred to in Article 85(2).
Those implementing acts shall, whenever possible, allow the use of the standard model forms adopted by the Commission for the submission of other reports on official controls that the competent authorities are required to submit to the Commission in accordance with the rules referred to in Article 1(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 114
Annual reports by the Commission
By 31 January every year, the Commission shall make available to the public an annual report on the operation of official controls in the Member States, taking into account:
the annual reports submitted by the Member States in accordance with Article 113; and
the results of Commission controls performed in accordance with Article 116(1).
Article 115
Contingency plans for food and feed
The contingency plans for food and feed provided for in paragraph 1 shall specify:
the competent authorities to be involved;
the powers and responsibilities of the authorities referred to in point (a); and
channels and procedures for sharing information between competent authorities and other parties concerned as appropriate.
The Commission may adopt implementing acts concerning:
rules for the establishment of the contingency plans provided for in paragraph 1 of this Article to the extent necessary to ensure the consistent and effective use of the general plan for crisis management provided for in Article 55(1) of Regulation (EC) No 178/2002; and
the role of stakeholders in the establishment and operation of those contingency plans.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
TITLE VI
UNION ACTIVITIES
CHAPTER I
Commission controls
Article 116
Commission controls in Member States
Commission experts shall perform controls, including audits, in each Member State to:
verify the application of the rules referred to in Article 1(2) and those provided for in this Regulation;
verify the functioning of national control systems in the areas governed by the rules referred to in Article 1(2) and those provided for in this Regulation, and of the competent authorities which operate them;
investigate and collect information:
on official controls and enforcement practices in the areas governed by the rules referred to in Article 1(2) and those provided for in this Regulation;
on important or recurring problems with the application or enforcement of the rules referred to in Article 1(2);
in relation to emergency situations, emerging problems or new developments in the Member States in the areas governed by the rules referred to in Article 1(2) and those provided for in this Regulation.
Article 117
Reports by the Commission on controls in Member States
The Commission shall:
prepare a draft report on the findings and on recommendations addressing the shortcomings identified by its experts during controls performed in accordance with Article 116(1);
send to the Member State where those controls have been performed a copy of the draft report provided for in point (a) for its comments;
take the comments of the Member State referred to in point (b) into account in preparing the final report on the findings of the controls performed by its experts in the Member States as provided for in Article 116(1); and
make publicly available the final report referred to in point (c) and the comments of the Member State referred to in point (b).
Article 118
Programme of the Commission controls in Member States
The Commission shall, by means of implementing acts:
establish an annual or multiannual control programme for the controls to be performed by its experts in the Member States as provided for in Article 116(1); and
by the end of each year, communicate to the Member States the annual control programme or any update to the multiannual control programme for the following year.
Article 119
Obligations of the Member States as regards Commission controls
Member States shall:
take appropriate follow-up measures to remedy any specific or systemic shortcomings identified through the controls performed by the Commission experts in accordance with Article 116(1);
give the necessary technical assistance and provide the available documentation, including the results of the audits referred to in Article 6, upon justified request, and other technical support that Commission experts request to enable them to perform controls efficiently and effectively; and
give the necessary assistance to ensure that the Commission experts have access to all premises or parts of premises, animals and goods, and to information, including computing systems, relevant for the execution of their duties.
Article 120
Commission controls in third countries
Commission experts may perform controls in third countries in order to:
verify the compliance or equivalence of third-country legislation and systems, including official certification and the issuance of official certificates, official labels, official marks and other official attestations, with the requirements laid down in the rules referred to in Article 1(2);
verify the capacity of the third country control system to ensure that consignments of animals and goods exported to the Union comply with relevant requirements established by the rules referred to in Article 1(2) or with requirements recognised to be at least equivalent thereto;
collect information and data to elucidate the causes of recurring or emerging problems in relation to exports of animals and goods from a third country.
The controls provided for in paragraph 1 shall have particular regard to:
the legislation of the third country;
the organisation of the third country’s competent authorities, their powers and independence, the supervision to which they are subject and the authority they have to enforce the applicable legislation effectively;
the training of staff of the competent authority of the third country in the performance of official controls;
the resources including analytical, testing and diagnostic facilities available to competent authorities;
the existence and operation of documented control procedures and control systems based on priorities;
where applicable, the situation regarding animal health, animal welfare, zoonoses and plant health, and procedures for notifying the Commission and relevant international bodies of outbreaks of animal diseases and pests of plants;
the extent and operation of controls performed by the competent authority of the third country on animals, plants and their products arriving from other third countries; and
the assurances which the third country can give regarding compliance with, or equivalence to, the requirements laid down in the rules referred to in Article 1(2).
In order to facilitate the efficiency and effectiveness of the controls provided for in paragraph 1, the Commission may, prior to performing such controls, request that the third country concerned provide:
the necessary information referred to in Article 125(1); and
where appropriate and necessary, the written records on the controls its competent authorities perform.
Article 121
Frequency of Commission controls in third countries
The frequency of Commission controls in third countries referred to in Article 120 shall be determined on the basis of the following criteria:
a risk assessment of the animals and goods exported to the Union from the third country concerned;
the rules referred to in Article 1(2);
the volume and nature of animals and goods entering the Union from the third country concerned;
the outcome of controls already performed by the Commission experts or by other inspection bodies;
the outcome of official controls on animals and goods entering the Union from the third country concerned and of any other official controls that competent authorities of Member States have performed;
information received from the EFSA or similar bodies;
information received from internationally recognised bodies such as:
the World Health Organization;
the Codex Alimentarius Commission;
the World Organization for Animal Health (OIE);
European and Mediterranean Plant Protection Organization and any other regional plant protection organisations established under the International Plant Protection Convention (IPPC);
the secretariat of the IPPC;
Organisation for Economic Co-operation and Development;
United Nations Economic Commission for Europe;
the secretariat of the Cartagena Protocol on Biosafety to the Convention on Biological Biodiversity;
evidence of emerging disease situations or other circumstances that might result in animals and goods entering the Union from a third country presenting health or environmental risks or a risk of fraudulent or deceptive practices;
the need to investigate or respond to emergency situations in individual third countries.
Article 122
Reports by the Commission on controls in third countries
The Commission shall report on the findings of each control performed in accordance with Articles 120 and 121. Its report shall, where appropriate, contain recommendations.
The Commission shall make its reports publicly available.
Article 123
Programme of the Commission controls in third countries
The Commission shall communicate its programme of controls in third countries to Member States in advance and shall report on the results. The Commission may amend that programme to take account of developments in the areas governed by the rules referred to in Article 1(2). Any such amendment shall be communicated to the Member States in advance.
Article 124
Third-country controls in Member States
The participation by Commission experts in the controls referred to in paragraph 1 shall serve in particular to:
provide advice on the rules referred to in Article 1(2);
provide information and data available at Union level that may be useful for the control performed by the competent authorities of the third country;
facilitate consistency and uniformity with regard to controls performed by the competent authorities of third countries in different Member States.
CHAPTER II
Conditions for the entry into the Union of animals and goods
Article 125
Information on third countries' control systems
The Commission shall request third countries which intend to export animals and goods to the Union to provide the following accurate and up-to-date information on the general organisation and management of sanitary and phytosanitary control systems in their territory:
any sanitary or phytosanitary rules adopted or proposed within their territory;
risk-assessment procedures and factors taken into consideration for the assessment of risks and for the determination of the appropriate level of sanitary or phytosanitary protection;
any control and inspection procedures and mechanisms, including, where relevant, on animals or goods arriving from other third countries;
official certification mechanisms;
where appropriate, any measures taken following recommendations provided for in the first paragraph of Article 122;
where relevant, results of controls performed on animals and goods intended to be exported to the Union; and
where relevant, information on changes made to the structure and functioning of control systems adopted to meet Union sanitary or phytosanitary requirements or recommendations provided for in the first paragraph of Article 122.
Article 126
Establishment of additional conditions for entry into the Union of animals and goods
The conditions laid down in the delegated acts referred to in paragraph 1 shall identify animals and goods by referring to their codes from the Combined Nomenclature and may include:
the requirement that certain animals and goods shall only enter the Union from a third country or region of a third country which appears on a list drawn up by the Commission for that purpose;
the requirement that consignments of certain animals and goods from third countries be dispatched from, and obtained or prepared in, establishments which comply with the relevant requirements referred to in paragraph 1 or with requirements recognised to be at least equivalent thereto;
the requirement that consignments of certain animals and goods be accompanied by an official certificate, an official attestation, or by any other evidence that the consignments comply with the relevant requirements referred to in paragraph 1 or with requirements recognised to be at least equivalent thereto, including the results of the analysis performed by an accredited laboratory;
the obligation to provide the evidence referred to in point (c) in accordance with a specific format;
any other requirement necessary to ensure that certain animals and goods offer a level of protection of health and, as regards GMOs, also of the environment, equivalent to that ensured by the requirements referred to in paragraph 1.
Article 127
Inclusion in the list of third countries referred to in point (a) of Article 126(2)
The Commission shall decide on the request referred to in paragraph 2 taking into account, as appropriate:
the third country’s legislation in the sector concerned;
the structure and organisation of the competent authorities of the third country and its control services, the powers available to them, the guarantees that can be provided with regard to the application and enforcement of the legislation of the third country applicable to the sector concerned, and the reliability of the official certification procedures;
the performance by the competent authorities of the third country of adequate official controls and other activities to assess the presence of hazards for human, animal or plant health, for animal welfare or, in relation to GMOs and plant protection products, also for the environment;
the regularity and rapidity of information supplied by the third country on the presence of hazards for human, animal or plant health, for animal welfare or, in relation to GMOs and plant protection products, also for the environment;
the guarantees given by the third country that:
conditions applied to the establishments from which animals or goods are exported to the Union comply with requirements that are equivalent to those referred to in Article 126(1);
a list of the establishments referred to in point (i) is drawn up and kept up to date;
the list of establishments referred to in point (i) and updates thereof are communicated to the Commission without delay;
the establishments referred to in point (i) are the subject of regular and effective controls by the competent authorities of the third country;
the findings of controls performed by the Commission in the third country in accordance with Article 120(1);
any other information or data on the capability of the third country to ensure that only animals or goods which provide the same or an equivalent level of protection as that afforded by the relevant requirements referred to in Article 126(1) enter the Union.
Article 128
Special measures regarding the entry into the Union of certain animals and goods
The measures referred to in paragraph 1 shall identify animals and goods by referring to their codes from the Combined Nomenclature, and may include:
the prohibition of entry into the Union of the animals and goods referred to in paragraph 1 originating in or dispatched from the third countries concerned or regions thereof;
the requirement that the animals and goods referred to in paragraph 1 originating in or dispatched from certain third countries or regions thereof be subject, prior to dispatch, to specific treatment or controls;
the requirement that the animals and goods referred to in paragraph 1 originating in or dispatched from certain third countries or regions thereof be subject, upon entry into the Union, to specific treatment or controls;
the requirement that consignments of the animals and goods referred to in paragraph 1 of this Article originating in or dispatched from certain third countries or regions thereof, be accompanied by an official certificate, an official attestation, or by any other evidence that the consignment complies with requirements established by the rules referred to in Article 1(2) or with requirements recognised to be at least equivalent thereto;
the requirement that the evidence referred to in point (d) be provided in accordance with a specific format;
other measures necessary to contain the risk.
When adopting the measures referred to in paragraph 2, account shall be taken of:
the information collected in accordance with Article 125;
any other information that the third countries concerned have provided; and
where necessary, the results of Commission controls provided for in Article 120(1).
Article 129
Equivalence
In the areas governed by the rules referred to in Article 1(2), with the exclusion of points (d), (e), (g), and (h) of Article 1(2), the Commission may, by means of implementing acts, recognise that measures applied in a third country, or regions thereof, are equivalent to the requirements laid down in those rules, on the basis of:
a thorough examination of information and data provided by the third country concerned pursuant to Article 125(1); and
where appropriate, the satisfactory outcome of a control performed in accordance with Article 120(1).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
The implementing acts referred to in paragraph 1 shall set out the practical arrangements for the entry of animals and goods into the Union from the third country concerned, or regions thereof, and may include:
the nature and content of the official certificates or attestations that have to accompany the animals or goods;
specific requirements applicable to the entry into the Union of the animals or goods and the official controls to be performed at entry into the Union;
where necessary, procedures for drawing up and amending lists of regions or establishments in the third country concerned from which the entry of animals and goods into the Union is permitted.
CHAPTER III
Training of staff of the competent authorities and of other authorities
Article 130
Training and exchange of staff
The Commission shall organise those activities in cooperation with the Member States concerned.
The training activities referred to in paragraph 1 shall facilitate the development of a harmonised approach to official controls and other official activities in Member States. They shall include, as appropriate, training on:
this Regulation and the rules referred to in Article 1(2);
control methods and techniques relevant for the official controls and for the other official activities of the competent authorities;
production, processing and marketing methods and techniques.
Training activities aimed at disseminating such knowledge shall be included in the training programmes referred to in Article 5(4).
Such exchange may take place through the temporary secondment of staff of the competent authorities from one Member State to the other or through the exchange of such staff between the relevant competent authorities.
CHAPTER IV
Information management system
Article 131
Information management system for official controls (IMSOC)
Article 132
General functionalities of the IMSOC
The IMSOC shall:
allow for the computerised handling and exchange of information, data and documents necessary for the performance of official controls, resulting from the performance of official controls or the recording of the performance or outcome of official controls in all cases where this Regulation, the rules referred to in Article 1(2) or the delegated and implementing acts provided for in Articles 16 to 27 provide for the exchange among competent authorities, between the competent authorities and the Commission, and where appropriate with other authorities and the operators, of such information, data and documents;
provide a mechanism for the exchange of data, information and documents in accordance with Articles 102 to 108;
provide a tool to collect and manage the reports on official controls provided by Member States to the Commission;
allow for the production, handling and transmission, including in electronic form, of the journey log referred to in Article 5(4) of Regulation (EC) No 1/2005, of the records obtained by the navigation system referred to in Article 6(9) of that Regulation, of official certificates and of the CHED referred to in Article 56 of this Regulation; and
integrate the existing computerised systems managed by the Commission and used for the rapid exchange of data, information and documents in relation to risks to human, animal health and welfare, and plant health, as established by Article 50 of Regulation (EC) No 178/2002, Article 20 of Regulation (EU) 2016/429 and Article 103 of Regulation (EU) 2016/2031 and provide appropriate links between those systems and its other components.
Article 133
Use of the IMSOC in the case of animals and goods subject to certain official controls
The first subparagraph of this paragraph shall not apply to goods subject to the rules referred to in points (g) and (h) of Article 1(2).
In the case of animals or goods subject to the official controls referred to in Articles 44 to 64, the IMSOC shall:
enable the competent authorities at the border control posts and other competent authorities responsible for performing official controls on those animals or goods to exchange, in real time, data, information and documents concerning those animals and goods and on controls performed on those animals or goods;
enable the competent authorities at the border control posts to share and exchange relevant data, information and documents with customs authorities and other authorities responsible for performing controls on animals or goods entering the Union from third countries, and with operators involved in entry procedures, in accordance with the rules adopted pursuant to Articles 15(4) and 75(2) and with other relevant Union rules; and
support and operate the procedures referred to in point (a) of Article 54(3) and in Article 65(6).
Article 134
The functioning of the IMSOC
The Commission shall adopt implementing acts for the functioning of the IMSOC which lay down:
the technical specifications of the IMSOC and its system components, including the electronic data exchange mechanism for exchanges with existing national systems, identification of applicable standards, definition of message structures, data dictionaries, exchange of protocols and procedures;
the specific rules for the functioning of the IMSOC and of its system components to ensure protection of personal data and security of exchange of information;
the specific rules for the functioning and use of the IMSOC and of its components, including the rules to update and create the necessary links between the systems referred to in point (e) of Article 132 and in Article 133(4);
contingency arrangements to be applied in the event of unavailability of any of the functionalities of the IMSOC;
the cases where, and the conditions under which, the third countries and international organisations concerned may be granted partial access to the functionalities of the IMSOC and the practical arrangements of such access;
the cases where, and the conditions under which, the data, information and documents are to be transmitted using the IMSOC;
the rules concerning an electronic system under which electronic certificates issued by the competent authorities of third countries are to be accepted by the competent authorities; and
the cases where, and the conditions under which, exemptions from the use of the IMSOC can be granted to occasional users.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 135
Data protection
Article 136
Data security
Member States and the Commission shall ensure that the IMSOC complies with the rules on data security adopted by the Commission under Article 17 of Directive 95/46/EC and Article 22 of Regulation (EC) No 45/2001 respectively.
TITLE VII
ENFORCEMENT ACTION
CHAPTER I
Actions by the competent authorities and penalties
Article 137
General obligations of the competent authorities as regards enforcement action
Where necessary, actions taken in accordance with paragraph 2 shall include:
the performance of intensified official controls on animals, goods and operators for an appropriate period;
the official detention of animals and goods and of any unauthorised substances or products as appropriate.
Article 138
Actions in the event of established non-compliance
Where the non-compliance is established, the competent authorities shall take:
any action necessary to determine the origin and extent of the non-compliance and to establish the operator’s responsibilities; and
appropriate measures to ensure that the operator concerned remedies the non-compliance and prevents further occurrences of such non-compliance.
When deciding which measures to take, the competent authorities shall take account of the nature of that non-compliance and the operator’s past record with regard to compliance.
When acting in accordance with paragraph 1 of this Article, competent authorities shall take any measure they deem appropriate to ensure compliance with the rules referred to in Article 1(2), including, but not limited, to the following:
order or perform treatments on animals;
order the unloading, transfer to another means of transport, holding and care of animals, quarantine periods, the postponement of the slaughter of animals, and, if necessary, order that veterinary assistance be sought;
order treatments on goods, the alteration of labels or corrective information to be provided to consumers;
restrict or prohibit the placing on the market, the movement, the entry into the Union or the export of animals and goods; and prohibit their return to the Member State of dispatch or order their return to the Member State of dispatch;
order the operator to increase the frequency of own controls;
order certain activities of the operator concerned to be subject to increased or systematic official controls;
order the recall, withdrawal, removal and destruction of goods, authorising, where appropriate, the use of the goods for purposes other than those for which they were originally intended;
order the isolation or closure, for an appropriate period of time, of all or part of the business of the operator concerned, or its establishments, holdings or other premises;
order the cessation for an appropriate period of time of all or part of the activities of the operator concerned and, where relevant, of the internet sites it operates or employs;
order the suspension or withdrawal of the registration or approval of the establishment, plant, holding or means of transport concerned, of the authorisation of a transporter or of the certificate of competence of the driver;
order the slaughter or killing of animals provided that this is the most appropriate measure to safeguard human health as well as animal health and welfare.
The competent authorities shall provide the operator concerned, or its representative, with:
written notification of their decision concerning the action or measure to be taken in accordance with paragraphs 1 and 2, together with the reasons for that decision; and
information on any right of appeal against such decisions and on the applicable procedure and time limits with respect to such right of appeal.
The competent authorities, in the case of issuance of false or misleading official certificates or in the case of abuse of official certificates, shall take appropriate measures, including:
the temporary suspension of the certifying officer from its duties;
the withdrawal of the authorisation to sign official certificates;
any other measure to prevent a reoccurrence of the offences referred to in Article 89(2).
Article 139
Penalties
Article 140
Reporting of infringements
The mechanisms referred to in paragraph 1 shall include at least:
procedures for the receipt of reports of infringements and their follow-up;
appropriate protection for persons reporting an infringement against retaliation, discrimination or other types of unfair treatment; and
protection of personal data of the person reporting an infringement in accordance with Union and national law.
CHAPTER II
Union enforcement measures
Article 141
Serious disruption in a Member State's control system
Where the Commission has evidence of a serious disruption in a Member State’s control system and such disruption may constitute a widespread risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, or result in a widespread infringement of the rules referred to in Article 1(2), it shall, by means of implementing acts, adopt one or more of the following measures, to be applied until such disruption is eliminated:
the prohibition to make available on the market or to transport, move or otherwise handle certain animals or goods concerned by the disruption in the control system;
special conditions for the activities, animals or goods referred to in point (a);
the suspension of the operation of official controls in border control posts or other control points concerned by the disruption in the official control system or the withdrawal of such border control posts or other control points;
other appropriate temporary measures necessary to contain that risk until the disruption in the control system is eliminated.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
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
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
CHAPTER II
Transitional and final provisions
Article 146
Repeals
Article 147
Relation with Regulation (EC) No 882/2004
The designation of each of the European Union reference laboratories referred to in Annex VII to Regulation (EC) No 882/2004 shall remain effective until a designation of a European Union reference laboratory in the same area takes place in accordance with Article 93 of this Regulation.
Article 148
Relation with Regulations (EC) No 852/2004 and (EC) No 853/2004 regarding approval of food business establishments
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
Directive 98/58/EC is amended as follows:
Article 6 is amended as follows:
paragraph 1 is deleted;
paragraph 2 is replaced by the following:
in paragraph 3, point (a) is deleted;
Article 7 is deleted.
Article 152
Amendments to Directive 1999/74/EC
Directive 1999/74/EC is amended as follows:
Article 8 is amended as follows:
paragraph 1 is deleted;
paragraph 2 is replaced by the following:
in paragraph 3, point (a) is deleted;
Article 9 is deleted.
Article 153
Amendments to Regulation (EC) No 999/2001
Regulation (EC) No 999/2001 is amended as follows:
Articles 19 and 21 are deleted;
in Annex X, Chapters A and B are deleted.
Article 154
Amendments to Regulation (EC) No 1/2005 and related transitional measures
Regulation (EC) No 1/2005 is amended as follows:
Article 2 is amended as follows:
point (f) is replaced the following:
“competent authority” means competent authorities as defined in Article 3(3) of Regulation ►C1 (EU) 2017/625 ◄ ’;
point (i) is replaced by the following:
“exit point” means an exit point as defined in Article 3(39) of Regulation ►C1 (EU) 2017/625 ◄ ’;
point (p) is replaced by the following:
“official veterinarian” means an official veterinarian as defined in Article 3(32) of Regulation ►C1 (EU) 2017/625 ◄ ’.
Articles 14, 15, 16 and 21, Article 22(2), and Articles 23, 24 and 26 are deleted.
Article 27 is amended as follows:
paragraph 1 is deleted;
paragraph 2 is replaced by the following:
Article 28 is deleted.
Article 155
Amendments to Regulation (EC) No 396/2005 and related transitional measures
Article 156
Amendments to Directive 2007/43/EC
Directive 2007/43/EC is amended as follows:
In Article 2(1), points (c) and (d) are replaced by the following:
“official veterinarian” means an official veterinarian as defined in Article 3(32) of Regulation ►C1 (EU) 2017/625 ◄ ;
Article 7 is amended as follows:
paragraph 1 is deleted;
paragraph 2 is replaced by the following:
Article 157
Amendments to Directive 2008/119/EC
Directive 2008/119/EC is amended as follows:
Article 7 is amended as follows:
paragraphs 1 and 2 are deleted;
paragraph 3 is replaced by the following:
Article 9 is deleted.
Article 158
Amendments to Directive 2008/120/EC
Directive 2008/120/EC is amended as follows:
Article 8 is amended as follows:
paragraphs 1 and 2 are deleted;
paragraph 3 is replaced by the following:
Article 10 is deleted.
Article 159
Amendments to Regulation (EC) No 1099/2009
Regulation (EC) No 1099/2009 is amended as follows:
Article 22 is deleted.
Article 160
Amendments to Regulation (EC) No 1069/2009
Regulation (EC) No 1069/2009 is amended as follows:
Article 3 is amended as follows:
point (15) is replaced by the following:
“transit” means transit as defined in Article 3(44) of Regulation ►C1 (EU) 2017/625 ◄ .’;
Articles 45, 49 and 50 are deleted.
Article 161
Amendments to Regulation (EC) No 1107/2009
Regulation (EC) No 1107/2009 is amended as follows:
Article 68 is amended as follows:
the first paragraph is replaced by the following:
‘Member States shall submit to the Commission by 31 August each year a report, for the previous year, on the scope and the outcome of the official controls performed in order to verify compliance with this Regulation’;
the second and third paragraphs are deleted.
point (n) of Article 78(1) is deleted.
Article 162
Amendments to Regulation (EU) No 1151/2012
Regulation (EU) No 1151/2012 is amended as follows:
Article 36 is amended as follows:
the heading is replaced by the following: ‘Content of official controls’;
paragraphs 1 and 2 are deleted;
Article 37 is amended as follows:
in paragraph 1, the first subparagraph is replaced by the following:
In respect of protected designations of origin, protected geographical indications and traditional specialities guaranteed that designate products originating within the Union, verification of compliance with the product specification, before placing the product on the market, shall be carried out by:
the competent authorities designated in accordance with Article 4 of Regulation ►C1 (EU) 2017/625 ◄ ; or
delegated bodies as defined in Article 3(5) of Regulation ►C1 (EU) 2017/625 ◄ .’;
in paragraph 3, the first subparagraph is deleted;
in paragraph 4, the words ‘paragraphs 1 and 2’ are replaced by the words: ‘paragraph 2’;
Article 38 is deleted;
Article 39 is replaced by the following:
‘Article 39
Delegated bodies performing controls in third countries
The delegated bodies performing controls in the third countries referred to in paragraph 2(b) of Article 37 shall be accredited to the relevant harmonised standard for “Conformity assessment- Requirements for bodies certifying products, processes and services”. These delegated bodies may be accredited either by a national accreditation body outside the Union, in accordance with Regulation (EC) No 765/2008, or by an accreditation body outside the Union that is a signatory of a multilateral recognition arrangement under the auspices of the International Accreditation Forum.’.
Article 163
Amendments to Regulation (EU) No 652/2014
Regulation (EU) No 652/2014 is amended as follows:
Article 30(1) is replaced by the following:
To cover the costs they incur to implement the work programmes approved by the Commission, grants may be awarded to:
the European Union reference laboratories referred to in Article 93 of Regulation ►C1 (EU) 2017/625 ◄ of the European Parliament and of the Council ( *9 ) and to the European Union reference centres referred to in Article 29 of Regulation (EU) 2016/1012 of the European Parliament and of the Council ( *10 );
the European Union reference centres for animal welfare referred to in Article 95 of Regulation ►C1 (EU) 2017/625 ◄ ;
the European Union reference centres for the authenticity and integrity of the agri-food chain referred to in Article 97 of Regulation ►C1 (EU) 2017/625 ◄ .
the following Article is inserted:
‘Article 30a
Accreditation of national reference laboratories for plant health
Article 164
Amendments to Regulation (EU) 2016/429 and related transitional provisions
Regulation (EU) 2016/429 is amended as follows:
Article 4 is amended as follows:
point (51) is replaced by the following:
“Traces” means a system component integrated into the IMSOC as referred to in Articles 131 to 136 of Regulation ►C1 (EU) 2017/625 ◄ ;’;
point (53) is replaced by the following:
“official veterinarian” means an official veterinarian as defined in Article 3(32) of Regulation ►C1 (EU) 2017/625 ◄ ;’;
point (55) is replaced by the following:
“competent authority” means the central veterinary authority of a Member State responsible for the organisation of official controls and any other official activities in accordance with this Regulation and Regulation ►C1 (EU) 2017/625 ◄ , or any other authority to which that responsibility has been delegated;’;
in Article 229, paragraph (2) is replaced by the following:
Article 281 is deleted.
The following provisions shall continue to apply in relation to the matters governed by Regulation (EU) 2016/429, until the date of application of that Regulation:
Article 9 of Directive 89/662/EEC;
Article 10 of Directive 90/425/EEC;
Article 18(1), (3), (4), (5), (6), (7) and (8) of Directive 91/496/EEC;
Article 22(1), (3), (4), (5), (6) and (7) of Directive 97/78/EC.
Article 165
Amendments to Regulation (EU) 2016/2031 and related transitional provisions
Regulation (EU) 2016/2031 is amended as follows:
Article 10 is replaced by the following:
‘Article 10
Official confirmation by the competent authorities of the presence of a Union quarantine pest
Where a competent authority suspects, or has received evidence concerning, the presence of a Union quarantine pest, or a pest subject to measures adopted pursuant to Article 30(1), in a part of the territory of the respective Member State where that pest was previously not known to be present, or in a consignment of plants, plant products or other objects introduced into, intended to be introduced into, or moved within the Union territory, it shall immediately take any measures necessary to confirm on the basis of a diagnosis of an official laboratory as referred to in Article 37 of Regulation ►C1 (EU) 2017/625 ◄ (“to officially confirm”), whether that pest is present or not.
Pending the official confirmation of the presence of that pest, the Member States concerned shall, where applicable, take phytosanitary measures to eliminate the risk of spread of that pest.
The suspicion or evidence referred to in the first paragraph of this Article may be based on any information received pursuant to Articles 14 and 15, or from any other source.’;
in Article 11, the second paragraph is replaced by the following:
‘Notifications under the first paragraph shall be made by the single authority, as referred to in Article 4(2) of Regulation ►C1 (EU) 2017/625 ◄ , of the Member State concerned and through the electronic notification system referred to in Article 103.’;
in Article 25(2), point (a) is replaced by the following:
‘(a) the roles and responsibilities of the bodies involved in the execution of the plan, in case of a confirmed or suspected presence of the priority pest concerned, as well as the chain of command and procedures for the co-ordination of actions to be taken by competent authorities, other public authorities, as referred to in Article 4(2) of Regulation ►C1 (EU) 2017/625 ◄ , delegated bodies or natural persons involved, as referred to in Article 28(1) of that Regulation, laboratories and professional operators, including the co-ordination with neighbouring Member States and neighbouring third countries, where appropriate;’;
in Article 41, paragraph 4 is replaced by the following:
Where applicable, that notification shall also be made to the third country from which the plants, plant products or other objects were introduced into the Union territory.’;
in Article 44, paragraph 2 is replaced by the following:
in Article 49(6), the third subparagraph is replaced by the following:
‘Member States shall notify, through the electronic notification system referred to in Article 103 of this Regulation, the Commission and the other Member States of any case where the introduction of a plant, plant product or other object into the Union territory was refused, or its movement within the Union territory prohibited, because the Member State concerned considered that the prohibition referred to in point (c) of the second subparagraph of paragraph 2 of this Article was violated. Where applicable, that notification shall include the measures taken by that Member State on the plants, plant products or other objects concerned pursuant to Article 66(3) of Regulation ►C1 (EU) 2017/625 ◄ .’;
in Article 76, paragraphs 4 and 5 are replaced by the following:
The Commission is empowered to adopt delegated acts, in accordance with Article 105, to supplement this Regulation concerning the conditions for acceptance referred to in the first subparagraph of this paragraph, to ensure the reliability of those certificates.
in Article 77(1), the first subparagraph is replaced by the following:
in Article 91(1), the second subparagraph is replaced by the following:
‘Authorised operators implementing an approved pest risk management plan may be subject to inspections with a reduced frequency, as referred to in point (b) of Article 22(3) of Regulation ►C1 (EU) 2017/625 ◄ .’;
in Article 94(1), the first subparagraph is replaced by the following:
in Article 100, paragraph 5 is replaced by the following:
in Article 101, paragraph 6 is replaced by the following:
in Article 102, paragraph 4 is replaced by the following:
Article 103 is replaced by the following:
‘Article 103
Establishment of electronic notification system
The Commission shall establish an electronic system for the submission of notifications by the Member States.
That system shall be connected to, and compatible with, the IMSOC.’;
in Article 109, paragraph 1 is replaced by the following:
‘Directive 2000/29/EC is repealed, without prejudice to Article 165(2), (3) and (4) of Regulation ►C1 (EU) 2017/625 ◄ .’.
Article 166
Transitional measures for the adoption of delegated and implementing acts
Without prejudice to the dates of application referred to in Article 167 and transitional provisions provided for in this Chapter, the Commission is empowered to adopt delegated and implementing acts provided for in this Regulation as from 28 April 2017. Such acts shall apply from the date of application in accordance with Article 167, without prejudice to any transitional rules provided for in this Chapter.
Article 167
Entry into force and application
Unless otherwise provided for in paragraphs 2 to 4, it shall apply from 14 December 2019.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
TERRITORIES REFERRED TO IN POINT 40 OF ARTICLE 3, EXCEPT FOR THE APPLICATION OF POINT (G) OF ARTICLE 1(2)
The territory of the Kingdom of Belgium
The territory of the Republic of Bulgaria
The territory of the Czech Republic
The territory of the Kingdom of Denmark with the exception of the Faroe Islands and Greenland
The territory of the Federal Republic of Germany
The territory of the Republic of Estonia
The territory of Ireland
The territory of the Hellenic Republic
The territory of the Kingdom of Spain with the exception of Ceuta and Melilla
The territory of the French Republic
The territory of the Republic of Croatia
The territory of the Italian Republic
The territory of the Republic of Cyprus
The territory of the Republic of Latvia
The territory of the Republic of Lithuania
The territory of the Grand Duchy of Luxembourg
The territory of Hungary
The territory of the Republic of Malta
The territory of the Kingdom of the Netherlands in Europe
The territory of the Republic of Austria
The territory of the Republic of Poland
The territory of the Portuguese Republic
The territory of Romania
The territory of the Republic of Slovenia
The territory of the Slovak Republic
The territory of the Republic of Finland
The territory of the Kingdom of Sweden
The territory of the United Kingdom of Great Britain and Northern Ireland
ANNEX II
TRAINING OF STAFF OF THE COMPETENT AUTHORITIES
CHAPTER I
Subject matter for the training of staff performing official controls and other official activities
Different control methods and techniques, such as inspection, verification, screening, targeted screening, sampling, and laboratory analysis, testing and diagnosis
Control procedures
The rules referred to in Article 1(2)
Assessment of non-compliance with the rules referred to in Article 1(2)
The hazards in the production, processing and distribution of animals and goods
The different stages of production, processing and distribution, and the possible risks to human health, and where appropriate to the health of animals and plants, to the welfare of animals, to the environment
The evaluation of the application of HACCP procedures and of good agricultural practices
Management systems such as quality assurance programmes that the operators manage and their assessment in so far as these are relevant for the requirements set out in the rules referred to in Article 1(2)
Official certification systems
Contingency arrangements for emergencies, including communication between Member States and the Commission
Legal proceedings and implications of official controls
Examination of written, documentary material and other records, including those related to inter-laboratory comparative testing, accreditation and risk assessment, which may be relevant to the assessment of compliance with the rules referred to in Article 1(2); this may include financial and commercial aspects
Control procedures and requirements for entry into the Union of animals and goods arriving from third countries
Any other area necessary to ensure that official controls are performed in accordance with this Regulation
CHAPTER II
Subject areas for control procedures
The organisation of the competent authorities and the relationship between central competent authorities and authorities to which they have conferred tasks to perform official controls or other official activities
The relationship between competent authorities and delegated bodies or natural persons to which they have delegated tasks related to official controls or other official activities
A statement on the objectives to be achieved
Tasks, responsibilities and duties of staff
Sampling procedures, control methods and techniques, including laboratory analysis, testing and diagnosis, interpretation of results and consequent decisions
Screening and targeted screening programmes
Mutual assistance in the event that official controls require more than one Member State to take action
Action to be taken following official controls
Cooperation with other services and departments that may have relevant responsibilities or with operators
Verification of the appropriateness of methods of sampling and of laboratory analysis, testing and diagnosis
Any other activity or information required for the effective functioning of the official controls
ANNEX III
CHARACTERISATION OF METHODS OF ANALYSIS
Methods of analysis and measurement results should be characterised by the following criteria:
accuracy (trueness and precision),
applicability (matrix and concentration range),
limit of detection,
limit of quantification,
precision,
repeatability,
reproducibility,
recovery,
selectivity,
sensitivity,
linearity,
measurement uncertainty,
other criteria that may be selected as required.
The precision values referred to in point 1(e) shall either be obtained from a collaborative trial which has been conducted in accordance with an internationally recognised protocol on collaborative trials (e.g. ISO 5725 ‘Accuracy (trueness and precision) of measurement methods and results’) or, where performance criteria for analytical methods have been established, be based on criteria compliance tests. The repeatability and reproducibility values shall be expressed in an internationally recognised form (e.g. the 95 % confidence intervals as defined by ISO 5725 ‘Accuracy (trueness and precision) of measurement methods and results’). The results from the collaborative trial shall be published or freely available.
Methods of analysis which are applicable uniformly to various groups of commodities should be given preference over methods which apply only to individual commodities.
In situations where methods of analysis can only be validated within a single laboratory, those methods should be validated in accordance with internationally accepted scientific protocols or guidelines or, where performance criteria for analytical methods have been established, be based on criteria compliance tests.
Methods of analysis adopted under this Regulation should be edited in the standard layout for methods of analysis recommended by the ISO.
ANNEX IV
CHAPTER I
Fees or charges for the official controls on consignments of animals and goods entering the Union
I. CONSIGNMENTS OF LIVE ANIMALS
Bovine animals, equidae, pigs, sheep, goats, poultry, rabbits and small game birds or ground game, wild boar and wild ruminants:
Animals of other species:
II. CONSIGNMENTS OF MEAT
III. CONSIGNMENTS OF FISHERY PRODUCTS
Fishery products not in bulk:
EUR 55 per consignment, up to 6 tonnes, and
EUR 9 per tonne, over 6 and up to 46 tonnes, or
EUR 420 per consignment, over 46 tonnes.
Fishery products, transported as break bulk shipment:
EUR 600 per vessel, with a cargo of fishery products up to 500 tonnes,
EUR 1 200 per vessel, with a cargo of fishery products over 500 and up to 1 000 tonnes,
EUR 2 400 per vessel, with a cargo of fishery products over 1 000 and up to 2 000 tonnes,
EUR 3 600 per vessel, with a cargo of fishery products of more than 2 000 tonnes.
IV. CONSIGNMENTS OF MEAT PRODUCTS, POULTRY MEAT, WILD GAME MEAT, RABBIT MEAT OR FARMED GAME MEAT
EUR 55 per consignment, up to 6 tonnes, and
EUR 9 per tonne, over 6 and up to 46 tonnes, or
EUR 420 per consignment, over 46 tonnes.
V. CONSIGNMENTS OF OTHER PRODUCTS OF ANIMAL ORIGIN DIFFERENT FROM MEAT PRODUCTS FOR HUMAN CONSUMPTION
Other products of animal origin for human consumption not in bulk;
EUR 55 per consignment, up to 6 tonnes, and
EUR 9 per tonne, over 6 and up to 46 tonnes, or
EUR 420 per consignment, over 46 tonnes.
Other products of animal origin for human consumption transported as break bulk shipment:
EUR 600 per vessel, with a cargo of products up to 500 tonnes,
EUR 1 200 per vessel, with a cargo of products over 500 and up to 1 000 tonnes,
EUR 2 400 per vessel, with a cargo of products over 1 000 and up to 2 000 tonnes,
EUR 3 600 per vessel, with a cargo products of more than 2 000 tonnes.
VI. CONSIGNMENTS OF ANIMAL BY-PRODUCTS AND FEED OF ANIMAL ORIGIN
Consignment of animal by-product and feed of animal origin transported not in bulk:
EUR 55 per consignment, up to 6 tonnes, and
EUR 9 per tonne, over 6 and up to 46 tonnes, or
EUR 420 per consignment, over 46 tonnes.
Animal by-products and feed of animal origin, transported as break bulk shipment:
EUR 600 per vessel, with a cargo of products up to 500 tonnes,
EUR 1 200 per vessel, with a cargo of products over 500 and up to 1 000 tonnes,
EUR 2 400 per vessel, with a cargo of products over 1 000 and up to 2 000 tonnes,
EUR 3 600 per vessel, with a cargo products of more than 2 000 tonnes.
VII. CONSIGNMENTS OF ANIMALS AND GOODS FROM THIRD COUNTRIES TRANSITING OR TRANSHIPPED
EUR 30 for consignment increased by EUR 20 per quarter of an hour for every member of staff involved in the controls.
VIII. CONSIGNMENTS OF PLANTS, PLANT PRODUCTS AND OTHER PRODUCTS, OBJECTS AND MATERIALS CAPABLE OF HARBOURING OR SPREADING PESTS OF PLANTS
For documentary checks: EUR 7 per consignment.
For identity checks:
EUR 7 per consignment up to a size of a truck load, a railway wagon load or the load of a container of comparable size,
EUR 14 per consignment bigger than the above size.
For plant health checks, in accordance with the following specifications:
cuttings, seedlings (except forestry reproductive material), young plants of strawberries or of vegetables:
shrubs, trees (other than cut Christmas trees), other woody nursery plants including forest reproductive material (other than seed):
bulbs, corms, rhizomes, tubers, intended for planting (other than tubers of potatoes):
seeds, tissue cultures:
other plants intended for planting, not specified elsewhere in this point:
cut flowers:
branches with foliage, parts of conifers (other than cut Christmas trees):
cut Christmas trees:
leaves of plants, such as herbs, spices and leafy vegetables:
fruits, vegetables (other than leafy vegetables):
tubers of potatoes:
wood (other than bark):
soil and growing medium, bark:
grain:
other plants or plant products not specified elsewhere in this point:
Where a consignment does not consist exclusively of products coming under the description of the relevant indent, those parts thereof consisting of products coming under the description of the relevant indent (lot or lots) shall be treated as a separate consignment.
CHAPTER II
Fees or charges for the official controls in slaughterhouses, cutting plants, game-processing plants, milk production and producing and placing on the market fishery products and aquaculture products
I. FEES OR CHARGES FOR THE OFFICIAL CONTROLS IN SLAUGHTERHOUSES
Beef meat:
adult bovine animals: 5 EUR/animal,
young bovine animals: 2 EUR/animal,
solipeds/equidae meat: 3 EUR/animal,
pigmeat: animals of a carcass weight:
of less than 25 kg: 0,5 EUR/animal,
equal to or greater than 25 kg: 1 EUR/animal,
sheepmeat and goatmeat: animals of a carcass weight:
of less than 12 kg: 0,15 EUR/animal,
equal to or greater than 12 kg: 0,25 EUR/animal,
poultry meat:
poultry of genus Gallus and guinea fowl: 0,005 EUR/animal,
ducks and geese: 0,01 EUR/animal,
turkeys: 0,025 EUR/animal,
farmed rabbit meat: 0,005 EUR/animal,
quails and partridges: 0,002 EUR/animal.
II. FEES OR CHARGES FOR THE OFFICIAL CONTROLS IN CUTTING PLANTS
Per tonne of meat:
beef, veal, pig, solipeds/equidae, sheep and goatmeat: 2 EUR,
poultry and farmed rabbit meat: 1,5 EUR,
farmed and wild game meat:
III. FEES OR CHARGES FOR THE OFFICIAL CONTROLS IN GAME-PROCESSING PLANTS
small game birds: 0,005 EUR/animal,
small ground game: 0,01 EUR/animal,
ratites: 0,5 EUR/animal,
land mammals:
boar: 1,5 EUR/animal,
ruminants: 0,5 EUR/animal.
IV. FEES OR CHARGES FOR THE OFFICIAL CONTROLS ON MILK PRODUCTION
1 EUR per 30 tonnes
and
0,5 EUR/tonne thereafter.
V. FEES OR CHARGES FOR THE OFFICIAL CONTROLS ON PRODUCING AND PLACING ON THE MARKET FISHERY PRODUCTS AND AQUACULTURE PRODUCTS
First placing on the market of fishery and aquaculture products:
1 EUR/tonne for the first 50 tonnes in the month;
0,5 EUR/tonne thereafter.
First sale in fish market
0,5 EUR/tonne for the first 50 tonnes in the month;
0,25 EUR/tonne thereafter;
First sale in case of lack of or insufficient gradation for freshness and/or size:
1 EUR/tonne for the first 50 tonnes in the month;
0,5 EUR/tonne thereafter.
ANNEX V
CORRELATION TABLES REFERRED TO IN ARTICLE 146(2)
1. Regulation (EC) No 882/2004
Regulation (EC) No 882/2004 |
This Regulation |
Article 1(1), first subparagraph |
Article 1(1) |
Article 1(1), second subparagraph |
Article 1(2) |
Article 1(2) |
Article 1(4) |
Article 1(3) |
— |
Article 1(4) |
— |
Article 2 |
Article 3 |
Article 3(1) |
Article 9(1) |
Article 3(2) |
Article 9(4) |
Article 3(3) |
Article 10 |
Article 3(4) |
Article 9(6) |
Article 3(5) |
Article 9(6) |
Article 3(6) |
Article 9(7) |
Article 3(7) |
— |
Article 4(1) |
Article 4(1) |
Article 4(2) |
Article 5(1)(a), (c), (d), (e), (f), (g) and (i) |
Article 4(3) |
Article 4(2) |
Article 4(4) |
Article 5(1)(b) |
Article 4(5) |
Article 5(5) |
Article 4(6) |
Article 6(1) |
Article 4(7) |
— |
Article 5(1), first subparagraph |
Article 28(1) |
Article 5(1), second subparagraph |
— |
Article 5(1), third subparagraph |
Article 31(3) |
Article 5(2)(a), (b), (c) and (f) |
Article 29 |
Article 5(2)(d) |
— |
Article 5(2)(e) |
Article 32 |
Article 5(3) |
Article 33 |
Article 5(4) |
— |
Article 6 |
Article 5(4) |
Article 7(1), first subparagraph |
Article 11(1), first subparagraph |
Article 7(1), second subparagraph, point (a) |
Article 11(1), second subparagraph |
Article 7(1), second subparagraph, point (b) |
— |
Article 7(2), first sentence |
Article 8(1) |
Article 7(2), second sentence |
— |
Article 7(2), third sentence |
— |
Article 7(3) |
Article 8 (3) |
Article 8(1) |
Article 12(1) |
Article 8(2) |
Article 5(1)(h) |
Article 8(3)(a) |
Article 12(2) |
Article 8(3)(b) |
Article 12(3) |
Article 8(4) |
— |
Article 9(1) |
Article 13(1), first subparagraph |
Article 9(2) |
Article 13(1), second subparagraph |
Article 9(3) |
Article 13(2) |
Article 10 |
Article 14 |
Article 11(1) |
Article 34(1) and (2) |
Article 11(2) |
— |
Article 11(3) |
Article 34(4) |
Article 11(4) |
Article 34(6) |
Article 11(5) |
Article 35(1) |
Article 11(6) |
Article 35(2) |
Article 11(7) |
Article 34(5) |
Article 12(1) |
Article 37(1) |
Article 12(2) |
Article 37(4)(e) |
Article 12(3) |
Article 37(5)(c) |
Article 12(4) |
Article 39(2) |
Article 13 |
Article 115 |
Article 14(1) |
— |
Article 14(2) |
Article 45(3) |
Article 14(3) |
— |
Article 15(1) |
Article 44(1), first sentence |
Article 15(2) |
Article 44(3) and (5) |
Article 15(3) |
Article 44(3) and (5) |
Article 15(4) |
— |
Article 15(5) |
Article 47(1)(d) and (2)(b) and Article 54(4), first sentence |
Article 16(1) |
Article 45(1) |
Article 16(2) |
Article 44(2) |
Article 16(3), first sentence |
Article 45(2) |
Article 16(3), second sentence |
Article 34(5) |
Article 17(1), first indent |
Article 59(1) |
Article 17(1), second indent |
Article 56(1), (3)(a) and (4) and Article 58 |
Article 17(2) |
— |
Article 18 |
Article 65(1), (2) and (3) |
Article 19(1) |
Article 66(1) and (3) |
Article 19(2)(a) |
Article 67 |
Article 19(2)(b) |
Article 66(6) |
Article 19(3) |
Article 66(5) |
Article 19(4) |
Article 7 |
Article 20 |
Article 71 |
Article 21(1) |
Article 72(1) |
Article 21(2) |
Article 69 |
Article 21(3) |
Article 66(1) |
Article 21(4) |
Article 66(5) |
Article 22 |
Article 66(7), 67, last sentence, and Article 69(4) |
Article 23(1) |
Article 73(1) |
Article 23(2) |
Article 73(2) and 74 |
Article 23(3) |
Article 73(3) |
Article 23(4) |
Article 73(2) |
Article 23(5) |
Article 73(4)(a) |
Article 23(6) |
Article 73(2)(c) and (4)(b) |
Article 23(7) |
Article 74 |
Article 23(8) |
Article 74 |
Article 24(1) |
Article 75(1) |
Article 24(2) |
Article 57 |
Article 24(3) |
Article 46 |
Article 24(4) |
Article 76 |
Article 25(1) |
— |
Article 25(2)(a) |
— |
Article 25(2)(b) |
Article 77(1)(c) |
Article 25(2)(c) |
Article 77(1)(f) |
Article 25(2)(d) |
Article 48(c) and (d) and Article 77(1)(e) and (k) |
Article 25(2)(e) |
— |
Article 25(2)(f) |
Article 70 |
Article 25(2)(g) |
Article 77(1)(h) |
Article 25(2)(h) |
Article 46(2)(b) |
Article 26 |
Article 78(1) |
Article 27(1) |
Article 80 |
Article 27(2) |
Article 79 |
Article 27(3) |
— |
Article 27(4) |
Article 79(1) |
Article 27(5) |
— |
Article 27(6) |
— |
Article 27(7) |
— |
Article 27(8) |
Article 84(2) |
Article 27(9) |
Article 83(2) |
Article 27(10) |
— |
Article 27(11) |
Article 84(1) |
Article 27(12), first sentence |
Article 85 |
Article 27(12), second sentence |
— |
Article 28 |
— |
Article 29 |
— |
Article 30(1)(a) |
Article 87 |
Article 30(1)(b) |
Article 90(a) |
Article 30(1) (c) |
Article 88(2) |
Article 30(1)(d) |
Article 90(b) and (f) |
Article 30(1)(e) |
Article 90(c) |
Article 30(1)(f) |
Article 90(d) |
Article 30(1)(g) |
Article 90(e) |
Article 30(2)(a) |
Article 89(1)(f) |
Article 30(2)(b) |
Article 89(1)(d) |
Article 30(3) |
— |
Article 31 |
— |
Article 32(1)(a) |
Article 94(2)(a) |
Article 32(1)(b) |
Article 94(2)(c) |
Article 32(1)(c) |
Article 94(2)(d) |
Article 32(1)(d) |
Article 94(2)(e) |
Article 32(1)(e) |
Article 94(2)(f) |
Article 32(1)(f) |
Article 94(2)(h) |
Article 32(2)(a) |
Article 94(2)(a), (c) and (d) |
Article 32(2)(b) |
Article 94(2)(i) |
Article 32(2)(c) |
Article 94(2)(e) |
Article 32(2)(d) |
Article 94(2)(h) |
Article 32(2)(e) |
Article 94(2)(e) |
Article 32(3) |
Article 93(3)(a) |
Article 32(4)(a) |
Article 93(3)(c) |
Article 32(4)(b) |
Article 93(3)(d) |
Article 32(4)(c) |
Article 93(3)(d) |
Article 32(4)(d) |
Article 8 |
Article 32(4)(e) |
Article 93(3)(e) |
Article 32(4)(f) |
Article 94(2)(k)(iii) |
Article 32(4)(g) |
Article 93(3)(e) |
Article 32(4)(h) |
Article 93(3)(f) |
Article 32(5) |
Article 99(1) |
Article 32(6) |
Article 99(2) |
Article 32(7) |
— |
Article 32(8), first sentence |
Article 99(3) |
Article 32(8), second sentence |
Article 99(4) |
Article 32(9) |
— |
Article 33(1) |
Article 100(1) |
Article 33(2) |
Article 101(1) |
Article 33(3) |
Article 100(2) |
Article 33(4) |
Article 100(4) |
Article 33(5) |
Article 100(5) |
Article 33(6) |
Article 101(2) |
Article 33(7) |
— |
Article 34(1) |
Article 102(1) |
Article 34(2) |
Article 102(1) and (2) |
Article 34(3) |
Article 102(3) |
Article 35(1) |
Article 103(1) |
Article 35(2) |
Article 103(3) |
Article 35(3) |
Article 103(2) |
Article 35(4) |
— |
Article 36(1) |
Article 104(1)(c) |
Article 36(2), first sentence |
— |
Article 36(2), second sentence |
Article 104(2) |
Article 36(3), first subparagraph |
Article 104(3), first sentence |
Article 36(3), second subparagraph |
— |
Article 36(3), third subparagraph, first sentence |
Article 104(3)(c) |
Article 36(3), third subparagraph, second sentence |
Article 104(3)(b) |
Article 36(4) |
Article 104(3)(a) |
Article 37(1) |
Article 105(1) |
Article 37(2) |
Article 105(2) |
Article 38(1) |
Article 106(1) |
Article 38(2) |
Article 106(2)(c) |
Article 38(3) |
Article 106(3) |
Article 39(1) |
Article 107(1) |
Article 39(2) |
Article 107(2) |
Article 40(1) |
Article 108(1) |
Article 40(2) |
— |
Article 40(3) |
Article 108(2) |
Article 40(4) |
— |
Article 41 |
Article 109(1) |
Article 42(1)(a) |
— |
Article 42(1)(b) |
Article 111(2) |
Article 42(1)(c) |
Article 111(3) |
Article 42(2) |
Article 110(2) |
Article 42(3) |
Article 111(2) |
Article 43(1), first sentence |
— |
Article 43(1), second sentence |
— |
Article 43(1)(a) |
— |
Article 43(1)(b) |
— |
Article 43(1)(c) |
— |
Article 43(1)(d) to (j) |
— |
Article 43(1)(k) |
— |
Article 43(2) |
— |
Article 44(1) |
Article 113(1) |
Article 44(2) |
— |
Article 44(3) |
Article 113(1) |
Article 44(4), first subparagraph, first sentence |
Article 114(1) |
Article 44(4), first subparagraph, second sentence |
Article 114(2) |
Article 44(5) |
— |
Article 44(6) |
Article 114(1) |
Article 45(1) |
Article 116(1)(2) and (4) |
Article 45(2) |
Article 116(3) |
Article 45(3) |
Article 117 |
Article 45(4) |
Article 118 |
Article 45(5) |
Article 119 |
Article 45(6) |
— |
Article 46(1), first sentence |
Article 120(1) |
Article 46(1), second sentence |
Article 120(4) |
Article 46(1), third sentence |
Article 120(2) |
Article 46(2) |
Article 120(3) |
Article 46(3) |