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Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies
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have at its disposal facilities and expert personnel enabling it to show at all times, and especially when the disease in question first appears, the type and strain of the agent of TSE, and to confirm results obtained by regional diagnostic laboratories. Where it is not capable of identifying the strain-type of the agent, it shall set up a procedure to ensure that the identification of the strain is referred to the Community reference laboratory;
verify diagnostic methods used in regional diagnostic laboratories;
be responsible for coordination of diagnostic standards and methods within the Member State. To this end, it:
may provide diagnostic reagents to laboratories approved by the Member State;
is to control the quality of all diagnostic reagents used in the Member State;
is to periodically arrange comparative tests;
is to hold isolates of the agents of the disease in question, or corresponding tissues containing such agents, coming from cases confirmed in the Member State;
is to ensure confirmation of results obtained in diagnostic laboratories designated by the Member State;
is to cooperate with the Community reference laboratory.
Austria: | Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH, Institut für veterinärmedizinische Untersuchungen Mödling Robert Koch Gasse 17 A-2340 Mödling |
Belgium: | CERVA -CODA-VAR Centre d'Étude et de Recherches Vétérinaires et Agrochimiques Centrum voor Onderzoek in Diergeneeskunde en Agrochemie Veterinary and Agrochemical Research Centre Groeselenberg 99 B-1180 Bruxelles |
[F2Bulgaria: | Национален диагностичен научноизследователски ветеринарномедицински институт ‘ Проф. Д-р Георги Павлов ’ Национална референтна лаборатория ‘ Tрансмисивни спонгиформни енцефалопатии ’ бул. ‘ Пенчо Славейков ’ София 1606 (National Diagnostic Veterinary Research Institute ‘ Prof. Dr. Georgi Pavlov ’ National Reference Laboratory for Transmissible Spongiform Encephalopathies 15, Pencho Slaveykov Blvd. 1606 Sofia)] |
Cyprus: | State Veterinary Laboratories Veterinary Services CY-1417 Athalassa Nicosia |
Czech Republic: | Státní veterinární ústav Jihlava Rantířovská 93 586 05 Jihlava |
Denmark: | Danmarks Fødevareforskning Bülowsvej 27 DK-1790 København V |
Estonia: | Veterinaar- ja Toidulaboratoorium Kreutzwaldi 30 Tartu 51006 |
Finland: | Eläinlääkintä- ja elintarvikelaitos Hämeentie 57 FIN-00550 Helsinki |
France: | Agence française de sécurité sanitaire des aliments Laboratoire de pathologie bovine 31, avenue Tony Garnier 69 364 LYON CEDEX 07 |
Germany: | Friedrich-Loeffler-Institut, Bundesforschungsinstitut für Tiergesundheit Anstaltsteil Insel Riems Boddenblick 5A D-17498 Insel Riems |
Greece: | Ministry of Agriculture — Veterinary Laboratory of Larisa 7th km of Larisa — Trikala Highway GR-411 10 Larisa |
Hungary: | Országos Állategészségügyi Intézet (OÁI) Pf. 2. Tábornok u. 2. H-1581 Budapest |
Ireland: | Central Veterinary Research Laboratory Young's Cross Celbridge Co. Kildare |
Italy: | Istituto Zooprofilattico Sperimentale del Piemonte, Liguria e Valle d’Aosta — CEA Via Bologna, 148 I-10154 Torino |
Latvia: | State Veterinary Medicine Diagnostic Centre Lejupes Str. 3 Riga LV 1076 |
Lithuania: | Nacionalinė veterinarijos laboratorija J. Kairiūkščio g. 10 LT-08409 Vilnius |
Luxembourg: | CERVA -CODA-VAR Centre d'Étude et de Recherches Vétérinaires et Agrochimiques Centrum voor Onderzoek in Diergeneeskunde en Agrochemie Veterinary and Agrochemical Research Centre Groeselenberg 99 B-1180 Bruxelles |
Malta: | National Veterinary Laboratory Albert Town Marsa |
Netherlands: | Centraal Instituut voor Dierziektecontrole-Lelystad Houtribweg 3g 8221 RA Lelystad Postbus 2004 8203 AA Lelystad |
Poland: | Państwowy Instytut Weterynaryjny (PIWet) 24-100 Puławy al. Partyzantów 57 |
Portugal: | Laboratório Nacional de Investigação Veterinária Estrada de Benfica 701 P-1500 Lisboa |
[F2Romania: | Institutul de Diagnostic și Sănătate Animală Strada Dr. Staicovici nr. 63, sector 5 codul 050557, București.] |
Slovakia: | State Veterinary Institute Zvolen Pod dráhami 918 SK-960 86, Zvolen |
Slovenia: | National Veterinary Institute Gerbičeva 60 1000 Ljubljana |
Spain: | Laboratorio Central de Veterinaria (Algete) Ctra. de Algete km. 8 28110 Algete (Madrid) |
Sweden: | National Veterinary Institute S-751 89 Uppsala |
United Kingdom: | Veterinary Laboratories Agency Woodham Lane New Haw Addlestone Surrey KT15 3NB] |
Textual Amendments
F2 Inserted by Council Regulation (EC) No 1791/2006 of 20 November 2006 adapting certain Regulations and Decisions in the fields of free movement of goods, freedom of movement of persons, company law, competition policy, agriculture (including veterinary and phytosanitary legislation), transport policy, taxation, statistics, energy, environment, cooperation in the fields of justice and home affairs, customs union, external relations, common foreign and security policy and institutions, by reason of the accession of Bulgaria and Romania.
Textual Amendments
The Veterinary Laboratories Agency
Woodham Lane
New Haw
Addlestone
Surrey KT15 3NB
United Kingdom
to coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing BSE, specifically by:
storing and supplying corresponding tissues containing the agent, for the development or production of the relevant diagnostic tests or for typing strains of the agent;
supplying standard sera and other reference reagents to the national reference laboratories in order to standardise the tests and reagents used in the Member States;
building up and retaining a collection of corresponding tissues containing the agents and strains of TSEs;
organising periodic comparative tests of diagnostic procedures at Community level;
collecting and collating data and information on the methods of diagnosis used and the results of tests carried out in the Community;
characterising isolates of the TSE agent by the most up-to-date methods to allow greater understanding of the epidemiology of the disease;
keeping abreast of trends in surveillance, epidemiology and prevention of TSEs throughout the world;
maintaining expertise on prion diseases to enable rapid differential diagnosis;
acquiring a thorough knowledge of the preparation and use of diagnostic methods used to control and eradicate TSEs;
to assist actively in the diagnosis of outbreaks of TSEs in Member States by studying samples from TSE-infected animals sent for confirmatory diagnosis, characterisation and epidemiological studies;
to facilitate the training or retraining of experts in laboratory diagnosis with a view to the harmonisation of diagnostic techniques throughout the Community.
Any samples intended to be examined for the presence of a TSE shall be collected using the methods and protocols laid down in the latest edition of the Manual for diagnostic tests and vaccines for Terrestrial Animals of the International Office for Epizooties (IOE/OIE) (the Manual). In addition, or in the absence, of OIE methods and protocols, and to ensure that sufficient material is available, the competent authority shall ensure the use of sampling methods and protocols in accordance with guidelines issued by the Community Reference Laboratory. In particular the competent authority shall collect the appropriate tissues, according to the available scientific advice and the guidelines of the Community Reference Laboratory, in order to ensure the detection of all known strains of TSE in small ruminants and shall keep at least half of the collected tissues fresh but not frozen until the result of the rapid test is negative. Where the result is positive or inconclusive the residual tissues must be processed in accordance with the Community reference laboratory guidelines.
The samples shall be correctly marked as to the identity of the sampled animal.]
Textual Amendments
F4 Substituted by Commission Regulation (EC) No 727/2007 of 26 June 2007 amending Annexes I, III, VII and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance).
Any laboratory examination for TSE shall be carried out in laboratories approved for that purpose by the competent authority.
Samples from bovine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall be subject to a histopathological examination as laid down in the latest edition of the Manual, except where the material is autolysed. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the tissues shall be subjected to an examination by one of the other diagnostic methods laid down in the Manual (immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy). However, rapid tests cannot be used for this purpose.
If the result of one of those examinations is positive, the animals shall be regarded a positive BSE case.
Samples from bovine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part I (Monitoring in bovine animals) shall be examined by a rapid test.
When the result of the rapid test is inconclusive or positive, the sample shall immediately be subject to confirmatory examinations in an official laboratory. The confirmatory examination shall start by a histopathological examination of the brainstem as laid down in the latest edition of the Manual, except where the material is autolysed or otherwise not suitable for examination by histopathology. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the sample shall be subjected to an examination by one of the other diagnostic methods referred to in (a).
An animal shall be regarded a positive BSE case, if the result of the rapid test is positive or inconclusive, and either
the result of the subsequent histopathological examination is positive, or
the result of another diagnostic method referred to in (a) is positive.
Samples from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall be subject to a histopathological examination as laid down in the latest edition of the Manual, except where the material is autolysed. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the sample shall be subjected to an examination by immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy, as laid down in the Manual. However, rapid tests cannot be used for this purpose.
If the result of one of those examinations is positive, the animal shall be regarded a positive scrapie case.
Samples from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part II (Monitoring in ovine and caprine animals) shall be examined by a rapid test using the appropriate methods and protocols, according to the available scientific advice and the guidelines of the Community Reference Laboratory, in order to ensure the detection of all known strains of TSE.
When the result of the rapid test is inconclusive or positive, the sampled tissues shall immediately be sent to an official laboratory for confirmatory examinations by immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy, as referred to in (a). If the result of the confirmatory examination is negative or inconclusive, additional confirmatory testing shall be carried out according the guidelines of the Community reference laboratory.
If the result of one of the confirmatory examination is positive, the animal shall be regarded a positive TSE case.]
Primary molecular testing with a discriminatory immuno-blotting
Samples from clinical suspect cases and from animals tested in accordance with Annex III, Chapter A, Part II, points 2 and 3 which are regarded as positive scrapie cases following the examinations referred to in points (a) or (b), or which display characteristics which are deemed by the testing laboratory to merit investigation, shall be forwarded for further examination by a primary molecular typing method to:
Agence Française de Sécurité Sanitaire des Aliments, Laboratoire de pathologie bovine, 31, avenue Tony Garnier, BP 7033, F-69342, Lyon Cedex, France , or
Veterinary Laboratories Agency, Woodham Lane, New Haw, Addlestone, Surrey KT15 3NB, United Kingdom , or
to a laboratory, appointed by the competent authority, which has participated successfully in proficiency testing organised by the Community Reference Laboratory for the use of a molecular typing method, or
on a provisional basis until 1 May 2005 , the laboratories approved for this purpose by the CRL panel of experts.
Ring trial with additional molecular testing methods
Samples from scrapie cases in which the presence of BSE cannot be excluded according to the guidelines issued by the Community Reference Laboratory by the primary molecular testing referred to in (i), shall be forwarded immediately to the laboratories listed in point (d) after consultation with the Community Reference Laboratory, and with all the relevant information available. They shall be submitted to a ring trial with at least:
a second discriminatory immuno-blotting,
a discriminatory immunocytochemistry, and
a discriminatory ELISA (Enzyme linked ImmunoSorbent Assay)
[F4Further testing of positive TSE samples detected in infected flocks on the same holding shall be carried out at least on the first two positive TSE cases detected every year following the index case.]
The results shall be interpreted by the Community Reference Laboratory assisted by a panel of experts including a representative of the relevant National Reference Laboratory. The Commission shall be informed immediately about the outcome of that interpretation. Samples indicative for BSE by three different methods and samples inconclusive in the ring trial shall be further analysed by a mouse bioassay for final confirmation.
Further testing of samples taken from infected flocks on the same holding in accordance with the provisions of Annex III, Chapter A, Part II, point 5, shall be carried out in accordance with the advice of the Community Reference Laboratory, after consultation with the relevant National Reference Laboratory.
The laboratories approved for further molecular typing are:
Agence Française de Sécurité Sanitaire des Aliments
Laboratoire de pathologie bovine
31, avenue Tony Garnier
BP 7033
F-69342 Lyon Cedex
Centre CEA Fontenay-aux-Roses, BP 6
F-92265 Fontenay-aux-Roses Cedex
Service de Pharmacologie et d’Immunologie
Centre CEA Saclay, bâtiment 136
F-91191 Gif-sur-Yvette Cedex
Veterinary Laboratories Agency
Woodham Lane
New Haw
Addlestone
Surrey KT15 3NB
United Kingdom
Where methods and protocols are established for tests carried out to confirm the suspected presence of a TSE in a species other than bovine, ovine and caprine, they shall include at least a histopathological examination of brain tissue. The competent authority may also require laboratory tests such as immunocytochemistry, immuno-blotting, demonstration of characteristic fibrils by electron microscopy or other methods designed to detect the disease associated form of the prion protein. In any case at least one other laboratory examination shall be carried out if the initial histopathological examination is negative or inconclusive. At least three different examinations shall be carried out in the event of the first appearance of the disease.
In particular, where BSE is suspected in a species other than bovine animals, samples shall be submitted for strain-typing, where possible.
For the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), the following methods shall be used as rapid tests for the monitoring of BSE in bovine animals:
immuno-blotting test based on a Western blotting procedure for the detection of the Proteinase K resistant fragment PrP Res (Prionics-Check Western test),
chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer test & Enfer TSE Kit version 2.0, automated sample preparation),
microplate based immunoassay for the detection of PrP Sc (Enfer TSE Version 3),
sandwich immunoassay for PrP Res carried out following denaturation and concentration steps (Bio-Rad Te-SeE test),
microplate based immunoassay (ELISA) which detects Proteinase K resistant PrP Res with monoclonal antibodies (Prionics-Check LIA test),
conformation-dependent immunoassay, BSE antigen test kit (Beckman Coulter InPro CDI kit),
chemiluminescent ELISA for qualitative determination of PrP Sc (CediTect BSE test),
immunoassay using a chemical polymer for selective PrP Sc capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE Antigen Test Kit, EIA),
microplate based chemiluminescent immunoassay for the detection of PrP Sc in bovine tissues (Institut Pourquier Speed’it BSE),
lateral flow immunoassay using two different monoclonal antibodies to detect Proteinase K resistant PrP fractions (Prionics Check PrioSTRIP),
two-sided immunoassay using two different monoclonal antibodies directed against two epitopes presented in a highly unfolded state of bovine PrP Sc (Roboscreen Beta Prion BSE EIA Test Kit),
sandwich ELISA for the detection of Proteinase K resistant PrP Sc (Roche Applied Science PrionScreen),
antigen-capture ELISA using two different monocloncal antibodies to detect Proteinase K resistant PrP fractions (Fujirebio FRELISA BSE post-mortem rapid BSE Test).
For the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), the following methods shall be used as rapid tests for the monitoring of TSEs in ovine and caprine animals:
conformation-dependent immunoassay, BSE antigen test kit (Beckman Coulter InPro CDI kit),
sandwich immunoassay for PrP Res carried out following denaturation and concentration steps (Bio-Rad Te-SeE test),
sandwich immunoassay for PrP Res carried out following denaturation and concentration steps (Bio-Rad Te-SeE Sheep/Goat test),
chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer TSE Kit Version 2.0),
microplate based immunoassay for the detection of PrP Sc (Enfer TSE Version 3),
immunoassay using a chemical polymer for selective PrP Sc capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE-Scrapie Antigen Test Kit, EIA),
microplate based chemiluminescent immunoassay for the detection of PrP Sc in ovine tissues (POURQUIER’S-LIA Scrapie),
immuno-blotting test based on a Western blotting procedure for the detection of the Proteinase K resistant fragment PrP Res (Prionics-Check Western Small Ruminant test),
microplate based chemiluminescent immunoassay for the detection of Proteinase K resistant PrP Sc (Prionics Check LIA Small Ruminants).
In the case of all tests, sample tissue to which the test is to be applied must comply with the manufacturer’s instructions for use.
The producer of the rapid tests must have put in place a quality assurance system, approved by the Community Reference Laboratory (CRL) that ensures that the test performance does not change. The producer must provide the test protocol to the CRL.
Changes to rapid tests and to test protocols may be made only after prior notification to the CRL and provided that the CRL finds that the change does not alter the sensitivity, specificity or reliability of the rapid test. That finding shall be communicated to the Commission and to the national reference laboratories.]
Textual Amendments
(To be defined)]
Textual Amendments
F3 Substituted by Commission Regulation (EC) No 36/2005 of 12 January 2005 amending Annexes III and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards epidemio-surveillance for transmissible spongiform encephalopathies in bovine, ovine and caprine animals (Text with EEA relevance).
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