Regulation (EU) 2017/625 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

This Regulation refers to the following international standards (see below, at the end of the page, link to the standards):
**- EN ISO/IEC 17020 (see at the end of the text)

See below, selected parts of the legislative text:
Whereas
(...)
(46) The competent authorities should be able to delegate some of their tasks to other bodies. Appropriate conditions should be laid down to ensure that the impartiality, quality and consistency of the official controls and of the other official activities are preserved. The delegated body should in particular be accredited according to the International Organisation for Standardisation (ISO) standard for the performance of inspections.
(47) To ensure the reliability and consistency of official controls and other official activities across the Union, the methods used for sampling and for laboratory analyses, tests and diagnoses should meet scientific standards, satisfy the specific analytical, testing and diagnostic need of the laboratory concerned, and offer sound and reliable analytical, test and diagnostic results. Clear rules should be established for the choice of the method to be used where more than one is available from different sources, such as ISO, the European and Mediterranean Plant Protection Organization (EPPO), the International Plant Protection Convention (IPPC), the World Organization for Animal Health (OIE), European Union and national reference laboratories, or national law.
(...) (50) Laboratories designated by the competent authorities to carry out analyses, tests and diagnoses on samples taken in the context of official controls and other official activities should possess the expertise, equipment, infrastructure and staff to carry out such tasks to the highest standards. To ensure sound and reliable results, those laboratories should be accredited for the use of these methods according to standard EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’. The accreditation should be delivered by a national accreditation body operating in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council (16). (...)
TITLE I - SUBJECT MATTER, SCOPE AND DEFINITIONS


Article 1 - Subject matter and scope

  1. This Regulation lays down rules for:

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

(b) the financing of official controls;

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

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

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

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

  1. This Regulation shall apply to the official controls performed for the verification of compliance with the rules, whether established at Union level or by the Member States, to apply Union legislation, in the areas of:

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

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

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

(d) animal health requirements;

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

(f) welfare requirements for animals;

(g) protective measures against pests of plants;

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

(i) organic production and labelling of organic products;

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

  1. This Regulation shall also apply to official controls performed for the verification of compliance with requirements laid down in the rules referred to in paragraph 2 where those requirements are applicable to animals and goods entering the Union or to be exported from the Union.

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

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

(b) Directive 2010/63/EU of the European Parliament and of the Council (46);

(c) Directive 2001/82/EC of the European Parliament and of the Council (47).

  1. Articles 4, 5, 6, 8, Article 12(2) and (3), Articles 15, 18 to 27, 31 to 34, 37 to 42 and 78, Articles 86 to 108, point (b) of Article 112, Article 130 and Articles 131 to 141 shall also apply to other official activities performed by the competent authorities in accordance with this Regulation or with the rules referred to in paragraph 2 of this Article.

Article 2 - Official controls and other official activities

  1. For the purposes of this Regulation, ‘official controls’ means activities performed by the competent authorities, or by the delegated bodies or the natural persons to which certain official control tasks have been delegated in accordance with this Regulation, in order to verify:

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

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

  1. For the purposes of this Regulation, ‘other official activities’ means activities, other than official controls, which are performed by the competent authorities, or by the delegated bodies or the natural persons to which certain other official activities have been delegated in accordance with this Regulation, and with the rules referred to in Article 1(2), including activities aimed at verifying the presence of animal diseases or pests of plants, preventing or containing the spread of such animal diseases or pests of plants, eradicating those animal diseases or pests of plants, granting authorisations or approvals, and issuing official certificates or official attestations.

Article 3 - Definitions

For the purposes of this Regulation, the following definitions apply:

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

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

(3) ‘competent authorities’ means:

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

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

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

(4) ‘organic control authority’ means a public administrative organisation for organic production and labelling of organic products of a Member State to which the competent authorities have conferred, in whole or in part, their competences in relation to the application of Council Regulation (EC) No 834/2007 (48), including, where appropriate, the corresponding authority of a third country or operating in a third country;

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(19) ‘products of animal origin’ means products of animal origin as defined in point 8.1 of Annex I to Regulation (EC) No 853/2004 of the European Parliament and of the Council (49);

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

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

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

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

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

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

(26) ‘certifying officer’ means:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(45) ‘supervision by the customs authorities’ means customs supervision as defined in point (27) of Article 5 of Regulation (EU) No 952/2013 of the European Parliament and of the Council (50);

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

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

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

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

(50) ‘meat and edible meat offal’ means, for the purpose of point (a) of Article 49(2) of this Regulation, the products listed in sub-Chapters 0201 to 0208 of Chapter 2 of Section I of Part II of Annex I to Council Regulation (EEC) No 2658/87 (51);

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

(...)

CHAPTER III

Delegation of certain tasks of the competent authorities

Article 28

Delegation by the competent authorities of certain official control tasks

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

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

Article 29

Conditions for delegating certain official control tasks to delegated bodies

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

(a)

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

(b)

the delegated body:

(i)

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

(ii)

has a sufficient number of suitably qualified and experienced staff;

(iii)

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

(iv)

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

(v)

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

(c)

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

Article 30

Conditions for delegating certain official control tasks to natural persons

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

(a)

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

(b)

the natural persons:

(i)

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

(ii)

are suitably qualified and experienced;

(iii)

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

(c)

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

Article 31

Conditions for delegating certain tasks related to other official activities

  1. The competent authorities may delegate certain tasks related to other official activities to one or more delegated bodies subject to compliance with the following conditions:

(a)

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

(b)

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

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

(a)

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

(b)

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

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

Article 32

Obligations of the delegated bodies and natural persons

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

(a)

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

(b)

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

(c)

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

Article 33

Obligations of the delegating competent authorities

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

(a)

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

(b)

fully or partly withdraw the delegation without delay where:

(i)

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

(ii)

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

(iii)

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

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

CHAPTER IV - Sampling, analyses, tests and diagnoses


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Article 35 - Second expert opinion

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Article 37 - Designation of official laboratories

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Article 38 - Obligations of official laboratories

  1. Where the results of an analysis, test or diagnosis carried out on samples taken during official controls or other official activities indicate a risk to human, animal or plant health, or, as regards GMOs and plant protection products, also to the environment, or point to the likelihood of non-compliance, official laboratories shall inform immediately the competent authorities which designated them for that analysis, test or diagnosis and, where relevant, delegated bodies or natural persons to which tasks have been delegated. However, specific arrangements between the competent authorities, delegated bodies or natural persons to which tasks have been delegated and the official laboratories may specify that this information is not required to be provided immediately.

  2. Upon request by the European Union reference laboratory or national reference laboratory, official laboratories shall take part in inter-laboratory comparative tests or proficiency tests that are organised for the analyses, tests or diagnoses they perform as official laboratories.

  3. Official laboratories shall, upon request of the competent authorities, make available to the public the names of the methods used for analyses, tests or diagnoses performed in the context of official controls and other official activities.

  4. Official laboratories shall indicate, at the request of the competent authorities, together with the results, the method used for each analysis, testing or diagnosis, performed in the context of official controls and other official activities.

Article 39 - Audits of official laboratories

  1. The competent authorities shall organise audits of the official laboratories they have designated in accordance with Article 37(1) on a regular basis and any time they consider that an audit is necessary, unless they find such audits to be redundant considering the accreditation assessment referred to in point (e) of Article 37(4).

  2. 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:

(a) it no longer complies with the conditions provided for in Article 37(4) and (5);

(b) it does not comply with the obligations provided for in Article 38;

(c) 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

  1. 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:

(a) laboratories:

(i) whose sole activity is the detection of Trichinella in meat;

(ii) that only use the methods of detection of Trichinella referred to in Article 6 of Commission Implementing Regulation (EU) 2015/1375 (58);

(iii) 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

(iv) 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;

(b) laboratories which only carry out analyses, tests or diagnoses in the context of other official activities, provided that they:

(i) 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);

(ii) 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;

(iii) 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

(iv) have a quality assurance system in place to ensure sound and reliable results from the methods for laboratory analysis, test and diagnosis used.

  1. Where the methods used by the laboratories referred to in point (b) of paragraph 1 of this Article require confirmation of the result of the laboratory analysis, test or diagnosis, the confirmatory laboratory analysis, test or diagnosis shall be carried out by an official laboratory which complies with the requirements set out in point (e) of Article 37(4).

  2. The official laboratories designated in accordance with paragraph 1 shall be located in the Member States in whose territory the competent authorities which have designated them are located.

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:

(a) 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

(b) 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

  1. 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):

(a) when the use of that method is newly required by Union rules;

(b) 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

(c) 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.

  1. The temporary designation referred to in paragraph 1 shall be subject to the following conditions:

(a) 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;

(b) 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;

(c) the analyses, tests or diagnoses are carried out under the supervision of the competent authorities or the national reference laboratory for that method.

  1. The temporary designation provided for in paragraph 1 shall not exceed a period of one year. It may be renewed once for a further period of one year.

  2. The official laboratories designated in accordance with paragraph 1 shall be located in the Member States in whose territory the competent authorities which have designated them are located.

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TITLE III

REFERENCE LABORATORIES AND REFERENCE CENTRES

Article 92

Decision to establish a European Union reference laboratory

  1. 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:

(a)

the methods of analysis, test or diagnosis employed by the official laboratories designated in accordance with Article 37(1); and

(b)

the results of the analyses, tests and diagnoses performed by those official laboratories.

  1. A European Union reference laboratory shall be established where there is a recognised need to promote uniform practices in relation to the development or use of the methods referred to in point (a) of paragraph 1.

  2. The Commission shall review regularly the mandate and operation of the European Union reference laboratories.

  3. The Commission shall supplement this Regulation by adopting the decision to establish a European Union reference laboratory by means of a delegated act in accordance with Article 144.

Article 93

Designation of European Union reference laboratories

  1. The Commission shall, by means of implementing acts, designate European Union reference laboratories in the cases where a decision has been taken to establish such a laboratory in accordance with Article 92.

  2. The designations provided for in paragraph 1 shall:

(a)

follow a public selection process; and

(b)

be limited in time and with a minimum period of five years, or reviewed regularly.

  1. European Union reference laboratories shall:

(a)

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:

(i)

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;

(ii)

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

(iii)

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;

(b)

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;

(c)

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;

(d)

possess, or have access to, the infrastructure, equipment and products necessary to carry out the tasks assigned to them;

(e)

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;

(f)

be equipped, or have access to, the necessary equipment to perform their tasks in emergency situations; and

(g)

where relevant, be equipped to comply with relevant biosecurity standards.

  1. By way of derogation from point (a) of paragraph 3 of this Article, for the area governed by the rules referred to in point (g) of Article 1(2), the Commission may designate official laboratories, designated as such by the competent authorities on the basis of a derogation adopted pursuant to Article 41, as European Union reference laboratories irrespective of whether they fulfil the conditions provided for in point (a) of paragraph 3 of this Article.

  2. 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:

(a)

GMOs and genetically modified food and feed; and

(b)

feed additives.

  1. The confidentiality obligations of staff, referred to in Article 8, shall apply mutatis mutandis to staff of the European Union reference laboratories.

Article 94

Responsibilities and tasks of European Union reference laboratories

  1. European Union reference laboratories shall contribute to the improvement and harmonisation of methods of analysis, test or diagnosis to be used by official laboratories designated in accordance with Article 37(1) and of the analytical, testing and diagnostic data generated by them.

  2. 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:

(a)

providing national reference laboratories with details and guidance on the methods of laboratory analysis, testing or diagnosis, including reference methods;

(b)

providing reference materials to national reference laboratories;

(c)

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;

(d)

coordinating practical arrangements necessary to apply new methods of laboratory analysis, testing or diagnosis, and informing national reference laboratories of advances in this field;

(e)

conducting training courses for staff from national reference laboratories and, if needed, from other official laboratories, as well as of experts from third countries;

(f)

providing scientific and technical assistance to the Commission within the scope of their mission;

(g)

providing information on relevant national, Union and international research activities to national reference laboratories;

(h)

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);

(i)

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;

(j)

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;

(k)

where relevant for their area of competence, establishing and maintaining:

(i)

reference collections of pests of plants and/or reference strains of pathogenic agents;

(ii)

reference collections of materials intended to come into contact with food used to calibrate analytical equipment and provide samples thereof to national reference laboratories;

(iii)

up-to-date lists of available reference substances and reagents and of manufacturers and suppliers of such substances and reagents; and

(l)

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.

  1. European Union reference laboratories shall publish the list of the national reference laboratories designated by the Member States in accordance with Article 100(1).

Article 95

Designation of European Union reference centres for animal welfare

  1. The Commission shall, by means of implementing acts, designate European Union reference centres for animal welfare that shall support the activities of the Commission and of the Member States in relation to the application of the rules referred to in point (f) of Article 1(2).

  2. The designations provided for in paragraph 1 shall:

(a)

follow a public selection process; and

(b)

be limited in time or reviewed regularly.

  1. European Union reference centres for animal welfare shall:

(a)

act impartially as regards the exercise of their tasks as European Union reference centres;

(b)

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;

(c)

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;

(d)

possess, or have access to, the infrastructure, the equipment and products necessary to carry out the tasks assigned to them; and

(e)

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:

(a)

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);

(b)

providing scientific and technical expertise for the development and application of the animal welfare indicators referred to in point (e) of Article 21(8);

(c)

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;

(d)

carrying out scientific and technical studies on the welfare of animals used for commercial or scientific purposes;

(e)

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

(f)

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

  1. The Commission may, by means of implementing acts, designate European Union reference centres that shall support the activities of the Commission and of the Member States to prevent, detect and combat violations of the rules referred to in Article 1(2) perpetrated through fraudulent or deceptive practices.

  2. The designations provided for in paragraph 1 shall:

(a)

follow a public selection process; and

(b)

be limited in time or reviewed regularly.

  1. European Union reference centres for the authenticity and integrity of the agri-food chain shall:

(a)

act impartially as regards the exercise of their tasks as European Union reference centres;

(b)

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;

(c)

have suitably qualified staff with adequate training in the areas referred to in point (b) and the necessary support staff;

(d)

possess, or have access to, the infrastructure, the equipment and the products necessary to carry out the tasks assigned to them; and

(e)

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:

(a)

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;

(b)

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;

(c)

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;

(d)

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

(e)

disseminating research findings and technical innovations in the fields within the scope of their mission.

Article 99

Obligations of the Commission

  1. The Commission shall publish and update, whenever necessary, the list of:

(a)

European Union reference laboratories provided for in Article 93;

(b)

European Union reference centres for animal welfare provided for in Article 95;

(c)

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

  1. The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the establishment of requirements, responsibilities and tasks for the European Union reference laboratories, the European Union reference centres for animal welfare and European Union reference centres for the authenticity and integrity of the agri-food chain in addition to those laid down in Article 93(3), Article 94, Article 95(3), Article 96, Article 97(3) and Article 98. Such delegated acts shall be limited to situations of new or emerging risks, new or emerging animal diseases or pests of plants or where new legal requirements so warrant.

  2. European Union reference laboratories and European Union reference centres shall be subject to Commission controls to verify compliance with the requirements of Article 93(3), Article 94, and Articles 95(3) and 97(3).

  3. 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:

(a)

by means of an implementing act, withdraw the designation of that laboratory or centre; or

(b)

take any other appropriate measure.

Article 100

Designation of national reference laboratories

  1. Member States shall designate one or more national reference laboratories for each European Union reference laboratory designated in accordance with Article 93(1).

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.

  1. The requirements provided for in point (e) of Article 37(4), Article 37(5), Article 39 and Article 42(1), points (a) and (b) of Article 42(2) and Article 42(3) shall apply to national reference laboratories.

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).

  1. National reference laboratories shall:

(a)

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;

(b)

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;

(c)

possess, or have access to, the infrastructure, equipment and products needed to carry out the tasks assigned to them;

(d)

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;

(e)

be equipped with, or have access to, the necessary equipment to perform their tasks in emergency situations; and

(f)

where relevant, be equipped to comply with relevant biosecurity standards.

  1. Member States shall:

(a)

communicate the name and address of each national reference laboratory to the Commission, the relevant European Union reference laboratory and other Member States;

(b)

make the information referred to in point (a) available to the public; and

(c)

update the information referred to in point (a) whenever necessary.

  1. Member States that have more than one national reference laboratory for a European Union reference laboratory shall ensure that such laboratories work closely together, so as to ensure efficient coordination between them, with other national laboratories and with the European Union reference laboratory.

  2. The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the establishment of requirements for national reference laboratories in addition to those laid down in paragraphs 2 and 3 of this Article. Such delegated acts shall be limited to ensuring coherence with any additional requirements adopted in accordance with Article 99(2).

Article 101

Responsibilities and tasks of national reference laboratories

  1. National reference laboratories shall, in their area of competence:

(a)

collaborate with the European Union reference laboratories, and participate in training courses and in inter-laboratory comparative tests organised by these laboratories;

(b)

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;

(c)

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;

(d)

ensure the dissemination to the competent authorities and official laboratories of information that the European Union reference laboratory supplies;

(e)

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;

(f)

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;

(g)

where necessary, conduct training courses for the staff of official laboratories designated under Article 37(1); and

(h)

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.

  1. The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the establishment of responsibilities and tasks for national reference laboratories in addition to those provided for in paragraph 1 of this Article. Such delegated acts shall be limited to ensuring coherence with any additional responsibilities and tasks adopted in accordance with Article 99(2).

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