Regulation (EU) 2017/625 of the European Parliament and of the CouncilDangos y teitl llawn

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).