EU Reference Laboratories (EURLs) National Reference Laboratories

(NRLs)Routine laboratories

Mandatory accreditation of laboratoriesAlexander Rogge

DG SANCO.E5- Enforcement

23 November 2011

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Outline1. EURLs (tasks and duties -

requirements)2. NRLs (designation - tasks and duties)3. Laboratory network4. EURL database5. EURL evaluation6. Mandatory accreditation ISO 17025

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1. EURLsEU Reference Laboratories (EURLs) support the activities of the Commission in relation to risk assessment and as appropriate risk management, mainly in the area of laboratory analyses, and coordinate activities of National Reference Laboratories (NRLs) in the Member States (MS).

Existing EURLs are listed in Annex VII to the Regulation (EC) No 882/2004 (currently 45 in the food/feed and animal health area).

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1. EURLs (food and feed)Milk and milk products FranceZoonoses (Salmonella) NetherlandsMarine biotoxins SpainViral and bacteriological contamination of bivalve molluscs United KingdomListeria monocytogenes FranceCoagulase positive Staphylococci, including Staphylococccus aureus FranceEscherichia coli, including Verotoxigenic E. coli (VTEC) ItalyCampylobacter SwedenParasites (in particular Trichinella, Echinococcus and Anisakis) ItalyAntimicrobial resistance DenmarkAnimal proteins in feedingstuffs BelgiumResidues of veterinary medicines and contaminants in food of animal origin (4) Netherlands, France, Germany, ItalyTransmissible spongiform encephalopathies (TSEs) United KingdomAdditives for use in animal nutrition BelgiumGenetically modified organisms (GMOs) ItalyMaterial intended to come into contact with foodstuffs ItalyResidues of pesticides (a) Cereals and feedingstuffs Denmark (b) Food of animal origin and commodities with high fat content Germany (c) Fruits and vegetables, including commodities with high water and high acid content Spain (d) Single residue methods GermanyHeavy metals in feed and food BelgiumMycotoxins BelgiumPolycyclic Aromatic Hydrocarbons (PAH) BelgiumDioxins and PCBs in feed and food Germany

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1. EURLs (animal health)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

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1. EURLs (tasks and duties)Article 32.1 of Regulation (EC) No 882/2004-food and feed

a) providing NRLs with details of analytical methods, including reference methods;

b) coordinating application by the NRLs of the methods by organising comparative testing and ensuring an appropriate follow-up of the latter;

c) coordinating practical arrangements needed to apply new analytical methods and informing NRLs of advances in this field;

d) conducting initial and further training courses for the benefit of staff from NRLs and of experts from developing countries;

e) providing scientific and technical assistance to the Commission;f) collaborating with laboratories responsible for analysing feed and

food in third countries.

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1.EURLs (tasks and duties)Article 32.2 of Regulation (EC) No 882/2004-animal health

a) coordinating the methods employed in the Member States for diagnosing diseases;

b) assisting actively in the diagnosis of disease outbreaks in MS by receiving pathogen isolates for confirmatory diagnosis, characterisation and epizootic studies;

c) facilitating the initial or further training of experts in laboratory diagnosis with a view to the harmonisation of diagnostic techniques throughout the EU;

d) collaborating, as regards methods of diagnosing animal diseases falling within their competence, with the competent laboratories in third countries where those diseases are prevalent;

e) conducting initial and further training courses for the benefit of staff from NRLs and of experts from developing countries.

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1. EURLs (requirements)Article 32.4 of Regulation (EC) No 882/2004

a) have suitably qualified staff with adequate training in diagnostic and analytical techniques applied in their area of competence;

b) possess the equipment and products needed to carry out the tasks assigned to them;

c) have an appropriate administrative infrastructure;d) ensure that their staff respect the confidential nature of certain

subjects, results or communications;e) have sufficient knowledge of international standards and practices;f) have available, if appropriate, an updated list of available

reference substances and reagents and an updated list of manufacturers and suppliers of such substances and reagents;

g) take account of research activities at national and EU level;h) have trained personnel available for emergency situations

occurring within the EU.

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2. NRLs (designation)

Article 33.1 Member States shall arrange for the designation of one or more NRLs for each EURL.

Article 33.4Member States shall communicate the name and address of each NRL to the Commission, the relevant EURL and other Member States.

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2. NRLs (tasks and duties)Article 33.2 of Regulation (EC) No 882/2004

a) collaborate with the EURLs in their area of competence;b) coordinate, for their area of competence, the activities of

routine official laboratories;c) where appropriate, organise comparative tests between the

routine official laboratories and ensure an appropriate follow-up of such comparative testing;

d) ensure the dissemination to the competent authority and routine official laboratories of information that the EURLs supplies;

e) provide scientific and technical assistance to the competent authority for the implementation of coordinated control plans.

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3. Official laboratory network in the EU

EU Reference Laboratories (EURLs)

Reg. 882/2004Annex VII

National ReferenceLaboratories (NRLs)

Routine official laboratories

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4. EURLs/NRLs database

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5. Evaluation of the EURLs Action Plan of the new Animal Health Strategy

Evaluation of 11 EURLs in the field of animal health and live animals (EURL for TSE)Evaluation carried out by an external contractor (9 months)Included visits to all EURLs, desk evaluation, interviews with key experts and stakeholders, surveys to CVOs and NRLsFinal report produced in November 2009

http://ec.europa.eu/food/animal/diseases/laboratories/eval_com_ref_labs_report_112009_en.pdf

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5. Evaluation of the EURLs26 EURLs feed and food (+2 EURLs animal health)

Evaluation completed by April 2011Performance of each individual EURL and the functioning of the networkRecommendations of both evaluations discussed and follow-up actions currently finalised by Commission (meeting with all EURLs in december 2011)

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6. Mandatory accreditationFormal recognition by an authoritative body of competence to

work to specified standards

Accreditation provides an impartial assessment against internationally recognised standards

Operates within a legal frameworkIs regarded as a public authority activityOperates on a non-profit basis and is independent from commercial motivationsIs independent and impartial

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6. Mandatory accreditation Official controls: why accreditation?

Results of laboratory analysis are a key element within the framework of official controls carried out in order to verify compliance with EU animal health, food and feed legislation and to ensure that food and feed are safe The results of laboratory tests must be as sound and as reliable as possible. The results need to be endorsed by all stakeholders across the food chain within the EU and by our trade partners.

Confidence No trade barriers

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6. Mandatory accreditation: legal basis and general applicable rules Article 12 of Regulation (EC) No 882/2004 of

the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

Article 6 of Commission Regulation (EC) No 1162/2009 laying down transitional measures for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004

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Article 12 (2) of Regulation (EC) No 882/2004

“2. .. competent authorities may only designate laboratories that operate and are assessed and accredited in accordance with the following European standards:(a)EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’;(b)EN ISO/IEC 17011 on ‘General requirements for accreditation bodies accrediting conformity assessment bodies’.”

6. Mandatory accreditation: legal basis and general applicable rules

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6. Mandatory accreditation: legal basis and general applicable rules

All laboratories involved in official controls must be accredited since 1 January 2010No derogations nor transitional periods are applicable anymoreThe only exception (until end of 2013): laboratories conducting Trichinella tests located in a slaughterhouse or a game handling establishment

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6. Mandatory accreditation: international recognition and acceptance

MS of the EU have established a network of national accreditation bodies.Ensures that the competence of all laboratories are assessed to the same principles and rules

Multilateral agreement (MLA) between the accreditation bodies members of EA creates mutual confidence: peer evaluations between EA members, equivalence of the accreditations

European co-operation for Acreditation (EA)

Thank you for your attention!