The European Union Reference Laboratories network Structure, objectives and responsibilities of the European reference laboratory system responsibilities in case of a crisis Frank Swartenbroux European Commission, DG Health and Food Safety 2015 BVL symposium Berlin
EU internal market = single market Smooth functioning is essential for success of internal market EU legislation aims at harmonization/alignment of control practices in Member States Implemented through MSs legislation Enforced by MSs control practices poss. based on sampling and analysis Aligning analytical practices to 100% through legislative work only would be very challenging
Routine laboratory analyses Performed by official control laboratories Increasing involvement of private laboratories "Distance" between private lab and EU Commission Creation of a three-layer network of laboratories European Union Reference Laboratories (EURLs) National Reference Laboratories (NRLs) Official control laboratories (OCLs)
EU Reference Laboratories Active in many areas: feed, food, animal health Designated in EU legislation Outstanding scientific and technical expertise To contribute to a high quality and uniformity of analytical results Current legal basis Article 32 of Regulation (EC) No 882/2004
EURLs technical requirements Suitably qualified staff & adequate training Necessary equipment and products Appropriate administrative infrastructure Respect the confidential nature of certain subjects, results or communications
EURLs technical requirements Sufficient knowledge of international standards and practices Updated list of available reference substances and reagents and of manufacturers and suppliers of such substances and reagents (if appropriate) Take account of research activities at national and EU level Always ready for emergency situations occurring within the EU
EURL responsibilities feed & food Provide NRLs with details of analytical methods, including reference methods (if applicable) Coordinate application by the NRLs by organising comparative testing including appropriate followup Coordinate practical arrangements needed to apply new analytical methods and informing NRLs
EURL responsibilities feed & food Organize training courses for staff of NRLs and experts from developing countries Scientific and technical assistance to the Commission, especially in cases where Member States contest the results of analyses Collaborate with laboratories responsible for analysing feed and food in third countries
EURL responsibilities animal health Coordinate the methods employed for diagnosing diseases Assist actively in the diagnosis of disease by receiving pathogen isolates for confirmatory diagnosis, characterisation and epizootic studies Facilitate initial or further training of experts in laboratory diagnosis with a view to the harmonisation of diagnostic techniques
EURL responsibilities animal health Collaborate with the competent laboratories in third countries where those diseases are prevalent Conduct training courses for staff of NRLs and experts from developing countries
EURLs for feed and food Analytical results compliance of feed / food Emphasis on harmonization & uniformity of results Proficiency testing & follow-up Method adaptation (or development) Knowledge sharing
EURLs for animal health & live animals Analytical results disease control Emphasis on rapid reaction and diagnosis Coordinate methods Actively assist in diagnosis PT and follow-up
EURLs for food and feed Milk and milk products Zoonoses(Salmonella) Marine biotoxins Viral and bacteriological contamination of bivalve molluscs Listeria monocytogenes Coagulase positive Staphylococci, including Staphylococccus aureus Escherichia coli, including Verotoxigenic E. coli(vtec) Campylobacter Parasites (in particular Trichinella, Echinococcus and Anisakis) Antimicrobial resistance Animal proteins in feedingstuffs Residues of veterinary medicines and contaminants in food of animal origin (4 x) Transmissible spongiform encephalopathies(tses) Additives for use in animal nutrition Genetically modified organisms (GMOs) Material intended to come into contact with foodstuffs Residues of pesticides (4x) Heavy metals in feed and food Mycotoxins Polycyclic Aromatic Hydrocarbons (PAH) Dioxins and PCBs in feed and food
EURLs for animal health & live animals Classical swine fever African horse sickness Avian influenza Newcastle disease Swine vesicular disease Fish diseases Mollusc diseases Rabies vaccination Bluetongue African swine fever Zootechnics Foot-and-mouth disease Brucellosis Equine diseases other than African horse sickness Crustacean diseases Rabies Bovine tuberculosis Bee health
National Reference Laboratories Appointed by national government Collaborate with the relevant EURL Participation to proficiency tests Coordinate activities of relevant OCLs Organise comparative tests between OCLs and ensure appropriate follow-up If appropriate If commercial scheme check participation
National Reference Laboratories Ensure the dissemination to the competent authority and OCLs of information received from EURLs Provide scientific and technical assistance to the competent authority for the implementation of coordinated control plans Responsible for carrying out other specific duties
Official control laboratories Official designated by competent authority Operate, assessed and accredited in accordance with EN ISO/IEC 17025 EN ISO/IEC 17025 on General requirements for the competence of testing and calibration laboratories EN ISO/IEC 17011 on General requirements for accreditation bodies accrediting conformity assessment bodies.
EURLs & budget EURLs receive annual EU funding to (partially) cover their operational cost Specific Commission Work Programme for EURLs Link between Commission objectives and EURL activities Resources made available for EURL financing in accordance with the provisions of Regulation (EC) No 652/2004 Annual (biannual) approval of programs for EURLs
EURL NRL network 45 EURLs for 477 NRLs 27 EURLs for feed and food 18 EURLs for animal health and live animals Budget for EURLs (x10 6 ) 2016 2017 2018 2019 2020 16 16,5 17 18 18,8
EURLs in the future? Review of R 882/2004 on-going Extend scope to plant health, plant reproductive material and animal by-products EURLs to be designated according to the needs in all agri-food sectors, no preestablished list additional / reshuffle EURLs regular review of EURLs new tasks in some areas Creation of European reference centres
Review of R 882/2004 on-going European Parliament first reading position April 2014: http://www.europarl.europa.eu/sides/getdoc.d o?type=report&reference=a7-2014- 0162&language=EN Council general approach: http://data.consilium.europa.eu/doc/document /ST-13209-2015-INIT/en/pdf Inter-institutional negotiations (including on amendments to Articles on EURLs) still on-going
Conclusions EURLs are the Commission's right hand when it comes to technical and analytical issues related to harmonized enforcement EURLs play an important role in the functioning of the internal market Little visibility EURLs contribute to and demonstrate EU excellence
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