Regulation (EU) 2017/625 of the European Parliament and of the CouncilShow full title

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.

2. 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.

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

4. 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.

3. 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.

4. 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.

5. 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.

6. 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.

3. 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.

3. 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.

3. 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.

2. 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.

3. 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).

4. 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.

2. 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).

3. 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.

4. 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.

5. 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.

6. 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.

2. 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).