EU Reference Laboratories (EURLs)
National Reference Laboratories
(NRLs)
Routine laboratories
Mandatory accreditation of
laboratories
Alexander Rogge
DG SANCO.E5- Enforcement
23 November 2011
Outline
1. EURLs (tasks and duties requirements)
2. NRLs (designation - tasks and duties)
3. Laboratory network
4. EURL database
5. EURL evaluation
6. Mandatory accreditation ISO 17025
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1. EURLs
EU 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 France
Zoonoses (Salmonella) Netherlands
Marine biotoxins Spain
Viral and bacteriological contamination of bivalve molluscs United Kingdom
Listeria monocytogenes France
Coagulase positive Staphylococci, including Staphylococccus aureus France
Escherichia coli, including Verotoxigenic E. coli (VTEC) Italy
Campylobacter Sweden
Parasites (in particular Trichinella, Echinococcus and Anisakis) Italy
Antimicrobial resistance Denmark
Animal proteins in feedingstuffs Belgium
Residues of veterinary medicines and contaminants in food of animal origin (4)
Netherlands, France, Germany, Italy
Transmissible spongiform encephalopathies (TSEs) United Kingdom
Additives for use in animal nutrition Belgium
Genetically modified organisms (GMOs) Italy
Material intended to come into contact with foodstuffs Italy
Residues 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 Germany
Heavy metals in feed and food Belgium
Mycotoxins Belgium
Polycyclic Aromatic Hydrocarbons (PAH) Belgium
Dioxins 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)
b)
c)
d)
e)
coordinating the methods employed in the Member States for
diagnosing diseases;
assisting actively in the diagnosis of disease outbreaks in MS by
receiving pathogen isolates for confirmatory diagnosis,
characterisation and epizootic studies;
facilitating the initial or further training of experts in laboratory
diagnosis with a view to the harmonisation of diagnostic
techniques throughout the EU;
collaborating, as regards methods of diagnosing animal
diseases falling within their competence, with the competent
laboratories in third countries where those diseases are
prevalent;
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 33.4
Member 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
National Reference
Laboratories (NRLs)
EU Reference
Laboratories (EURLs)
Reg. 882/2004
Annex VII
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 NRLs
Final 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 EURLs
26 EURLs feed and food (+2 EURLs
animal health)
Evaluation completed by April 2011
Performance of each individual EURL and
the functioning of the network
Recommendations 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 accreditation
Formal 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 framework
Is regarded as a public authority activity
Operates on a non-profit basis and is
independent from commercial motivations
Is 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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6. Mandatory accreditation: legal
basis and general applicable rules
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’.”
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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 2010
No derogations nor transitional periods
are applicable anymore
The 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
European co-operation for Acreditation (EA)
Multilateral agreement (MLA) between the
accreditation bodies members of EA creates
mutual confidence: peer evaluations between
EA members, equivalence of the accreditations
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Thank you for your attention!