The European Union Reference Laboratories network
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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 – BerlinEU 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 challengingRoutine 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 882/2004EURLs – technical requirements
• Suitably qualified staff & adequate training
• Necessary equipment and products
• Appropriate administrative infrastructure
• Respect the confidential nature of certain
subjects, results or communicationsEURLs – 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 follow- up • 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 foodEURLs 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
EURLsEURL – NRL network
45 EURLs for 477 NRLs
27 EURLs for feed and food
18 EURLs for animal health and live animals
Budget for EURLs (x106 €)
2016 2017 2018 2019 2020
16 16,5 17 18 18,8EURLs 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 pre-
established list additional / reshuffle EURLs
regular review of EURLs
new tasks in some areas
Creation of European reference centresReview 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-goingConclusions • 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
• Thank you for your attention • Question?
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