Commission Regulation (EU) No 1148/2014 of 28 October 2014 amending Annexes II, VII, VIII, IX 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
(1) Annex II is amended as follows: (a) Points 1 and 2 of Chapter B are replaced by the following: "1. Structure of the risk analysis The risk analyses shall comprise an entry assessment and an exposure assessment. 2. Entry assessment (external challenge) 2.1. The entry assessment shall consist of assessing the likelihood that the BSE agent has either been introduced into the country or region via commodities potentially contaminated with a BSE agent, or is already present in the country or region. The following risk factors shall be taken into account: (a) the presence or absence of the BSE agent in the country or region and, if the agent is present, its prevalence based on the outcome of surveillance activities; (b) the production of meat-and-bone meal or greaves from the BSE indigenous ruminant population; (c) imported meat-and-bone meal or greaves; (d) imported bovine and ovine and caprine animals; (e) imported animal feed and feed ingredients; (f) imported products of ruminant origin for human consumption, which may have contained tissues listed in point 1 of Annex V and may have been fed to bovine animals; (g) imported products of ruminant origin for in vivo use in bovine animals.
2.2. Special eradication schemes, surveillance and other epidemiological investigations (especially surveillance for BSE conducted on the bovine animals population) relevant to the risk factors listed in point 2.1 should be taken into ac-count in carrying out the entry assessment." (b) In point 3 of Chapter D, Table 2 is replaced by the following: "Table 2 Points targets for different adult bovine animals population sizes in a country or region Points targets for country or region Adult bovine animals population size (24 months and older) Type A surveillance Type B surveillance > 1000000 300000 150000 900001 -1000000 214600 107300 800001 -900000 190700 95350 700001 -800000 166900 83450 600001 -700000 143000 71500 500001 -600000 119200 59600 400001 -500000 95400 47700 300001 -400000 71500 35750 200001 -300000 47700 23850 100001 -200000 22100 11500 90001 -100000 19900 9950 80001 -90000 17700 8850 70001 -80000 15500 7750 60001 -70000 13000 6650 50001 -60000 11000 5500 40001 -50000 8800 4400 30001 -40000 6600 3300 20001 -30000 4400 2200 10001 -20000 2100 1050 9001 -10000 1900 950 8001 -9000 1600 800 7001 -8000 1400 700 6001 -7000 1200 600 5001 -6000 1000 500 4001 -5000 800 400 3001 -4000 600 300 2001 -3000 400 200 1001 -2000 200 100"
(2) In Annex VII, the first paragraph in point 2.2.1 of Chapter B is replaced by the following: "If BSE cannot be excluded after the results of the secondary molecular testing carried out in accordance with the methods and protocols set out in Annex X, Chapter C, point 3.2(c) (ii), the killing and complete destruction, without delay, of all animals, embryos and ova identified by the inquiry referred to in the second to fifth indents of point 1(b)." (3) In Annex VIII, Section A of Chapter A is amended as follows: (a) In point 1.2, paragraph (g) is replaced by the following: "(g) only the following ovine and caprine embryos/ova may be introduced: (i) embryos/ova from donor animals which have been kept since birth in a Member State with a negligible risk of classical scrapie, or in a holding with a negligible or a controlled risk of classical scrapie, or which meet the following requirements: they are permanently identified to enable trace back to their holding of birth they have been kept since birth in holdings in which no case of classical scrapie has been confirmed during their residency they showed no clinical sign of classical scrapie at the time of embryo/ova collection;
(ii) ovine embryos/ova carrying at least one ARR allele."
(b) In point 1.3, paragraph (g) is replaced by the following: "(g) only the following ovine and caprine embryos/ova may be introduced: (i) embryos/ova from donor animals which have been kept since birth in a Member State with a negligible risk of classical scrapie, or in a holding with a negligible or a controlled risk of classical scrapie, or which meet the following requirements: they are permanently identified to enable trace back to their holding of birth they have been kept since birth in holdings in which no case of classical scrapie has been confirmed during their residency they showed no clinical sign of classical scrapie at the time of embryo/ova collection;
(ii) ovine embryos/ova carrying at least one ARR allele."
(c) In point 2, the following point 3 is added: "2.3. The Member States or zone of the Member State with a negligible risk for classical scrapie are the following: Austria."
(d) Point 3.2 is replaced by the following: "3.2. The national scrapie control programmes of the following Member States are hereby approved: Denmark Finland Sweden."
(e) In point 4.2, paragraph (e) is replaced by the following: "(e) in the case of ovine embryos, be carrying at least one ARR allele."
(4) In Annex IX, point (ii) of point 2 of Chapter H is replaced by the following: "(ii) in the case of ovine embryos, the embryos carry at least one ARR allele." (5) Annex X is replaced by the following:
1. The designated national reference laboratory is to: (a) 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 official 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 EU reference laboratory; (b) verify diagnostic methods used in official diagnostic laboratories; (c) be responsible for coordination of diagnostic standards and methods within the Member State. To this end, it: may provide diagnostic reagents to official diagnostic laboratories; 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;
(d) is to cooperate with the EU reference laboratory, which includes the participation in the periodic comparative tests organised by the EU reference laboratory. Should a national reference laboratory fail in a comparative test organised by the EU reference laboratory, it shall take immediately all the corrective actions to remedy the situation and successfully pass the repeat comparative test or the next comparative test organised by the EU reference laboratory.
2. However, by way of derogation from point 1, Member States which do not have a national reference laboratory shall use the services of the EU reference laboratory or of national reference laboratories located in other Member States or European Free Trade Association (EFTA) Members. 3. The national reference laboratories are: Austria: Agentur für Gesundheit und Ernährungssicherheit GmbH (AGES) Institut für veterinärmedizinische Untersuchungen 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 Bulgaria: Национален диагностичен научноизследователски ветеринарномедицински институт "Проф. Д-р Георги Павлов" Национална референтна лаборатория "Tрансмисивни спонгиформни енцефалопатии" бул. "Пенчо Славейков" 15 София 1606 ( National Diagnostic Veterinary Research Institute "Prof. Dr Georgi Pavlov", National Reference Laboratory for Transmissible Spongiform Encephalopathies, 15 Pencho Slaveykov Blvd., 1606 Sofia )Croatia: Hrvatski veterinarski institut, Savska Cesta 143 10000 Zagreb Cyprus: State Veterinary Laboratories Veterinary Services CY-1417 Athalassa Nicosia Czech Republic: Státní veterinární ústav Jihlava (State Veterinary Institute Jihlava) National Reference Laboratory for BSE and Animal TSEs Rantířovská 93 586 05 Jihlava Denmark: Veterinærinstituttet Danmarks Tekniske Universitet Bülowsvej 27 DK-1870 Frederiksberg C ( National Veterinary Institute, Technical University of Denmark, 27, Bülowsvej, DK — 1870 Frederiksberg C )Estonia: Veterinaar- ja Toidulaboratoorium (Estonian Veterinary and Food Laboratory) Kreutzwaldi 30 Tartu 51006 Finland: Finnish Food Safety Authority Evira Research and Laboratory Department Veterinary Virology Research Unit- TSEs Mustialankatu 3 FI-00790 Helsinki France: ANSES-Lyon, Unité MND 31, avenue Tony Garnier 69 364 LYON Cedex 07 Germany: Friedrich-Loeffler-Institut Institute for Novel and Emerging Infectious Diseases at the Friederich-Loeffler-Institut Federal Research Institute for Animal Health Suedufer 10 D-17493 Greifswald Insel Riems Greece: Ministry of Agriculture — Veterinary Laboratory of Larissa 6th km of Larissa — Trikala Highway GR-41110 Larissa Hungary: Veterinary Diagnostic Directorate, National Food Chain Safety Office (VDD NFCSO) Tábornok u. 2 1143 Budapest Ireland: Central Veterinary Research Laboratory Department of Agriculture, Food and the Marine Backweston Campus Celbridge Co. Kildare Italy: Istituto Zooprofilattico Sperimentale del Piemonte, Liguria e Valle d'Aosta — CEA Via Bologna, 148 I-10154 Torino Latvia: Institute of Food Safety, Animal Health and Environment (BIOR) Lejupes Str. 3 Riga LV 1076 Lithuania: National Food and Veterinary Risk Assessment Institute J. Kairiūkščio str. 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: Veterinary Diagnostic Laboratory Department of Food Health and Diagnostics Veterinary Affairs and Fisheries Division Ministry for Rural Affairs and the Environment Albert Town Marsa Netherlands: Central Veterinary Instutute of Wageningen UR Edelhertweg 15 8219 PH Lelystad P.O. Box 2004 NL-8203 AA Lelystad Poland: Państwowy Instytut Weterynaryjny (PIWet) 24-100 Puławy al. Partyzantów 57 Portugal: Setor diagnóstico EET Laboratório de Patologia Unidade Estratégica de Investigação e Serviços de Produção e Saúde Animal Instituto Nacional de Investigação Agrária e Veterinária Rua General Morais Sarmento 1500-311 Lisboa Romania: Institutul de Diagnostic și Sănătate Animală (Institute for Diagnosis and Animal Health) Department of Morphology Strada Dr Staicovici nr. 63, 5 București 050557 Slovakia: State Veterinary Institute Zvolen Pod dráhami 918 SK-960 86, Zvolen Slovenia: University of Ljubljana, Veterinary faculty National Veterinary Institute Gerbičeva 60 SI-1000 Ljubljana Spain: Laboratorio Central de Veterinaria (Algete) Ctra. M-106 pk 1,4 28110 Algete (Madrid) Sweden: National Veterinary Institute S-751 89 Uppsala United Kingdom: Animal Health and Veterinary Laboratories Agency Woodham Lane New Haw, Addlestone, Surrey KT15 3NB
1. The EU reference laboratory for TSEs is: The Animal Health and Veterinary Laboratories Agency Woodham Lane New Haw Addlestone Surrey KT15 3NB United Kingdom 2. The functions and duties of the EU reference laboratory are: (a) to coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing TSEs and the determination of the prion protein genotype in ovine animals, specifically by: storing and supplying corresponding tissues containing the TSE agents, for the development or production of the relevant diagnostic tests or for typing strains of the TSE agents 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 for the procedures for the diagnosis of TSEs and for the determination of the prion protein genotype in ovine animals at EU level collecting and collating data and information on the methods of diagnosis used and the results of tests carried out in the EU 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;
(b) 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; (c) to facilitate the training or retraining of experts in laboratory diagnosis with a view to the harmonisation of diagnostic techniques throughout the EU.
(i) the immunohistochemical (IHC) method; (ii) Western blot; (iii) the demonstration of characteristic fibrils by electron microscopy; (iv) histopathological examination; (v) the combination of rapid tests as laid down in the third subparagraph.
(i) the confirmation is carried out in a national reference laboratory for TSEs; and (ii) one of the two rapid tests is a Western blot; and (iii) the second rapid test used: includes a negative tissue control and a bovine BSE sample as positive tissue control, is of a different type than the test used for the primary screening; and
(iv) if a rapid Western blot is used as the first test, the result of that test must be documented and the blot image submitted to the national reference laboratory for TSEs; and (v) where the result of the primary screening is not confirmed by the subsequent rapid test, the sample must be subjected to an examination by one of the other confirmatory methods; where the histopathological examination is used for that purpose, but proves to be inconclusive or negative, the tissues must be submitted to a further examination by one of the other confirmatory methods and protocols.
(i) the immunohistochemical (IHC) method; (ii) Western blot; (iii) the demonstration of characteristic fibrils by electron microscopy; (iv) histopathological examination; (v) the combination of rapid tests as laid down in the fourth subparagraph.
(i) the confirmation is carried out in a national reference laboratory for TSEs; and (ii) one of the two rapid tests is a Western blot; and (iii) the second rapid test used: includes a negative tissue control and a bovine BSE sample as positive tissue control, is of a different type than the test used for the primary screening; and
(iv) if a rapid Western blot is used as the first test, the result of that test must be documented and the blot image submitted to the national reference laboratory for TSEs; and (v) where the result of the primary screening is not confirmed by the subsequent rapid test, the sample must be subjected to an examination by one of the other confirmatory methods; where the histopathological examination is used for that purpose, but proves to be inconclusive or negative, the tissues must be submitted to a further examination by one of the other confirmatory methods and protocols.
(i) the immunohistochemical (IHC) method; (ii) Western blot; (iii) the demonstration of characteristic fibrils by electron microscopy; (iv) histopathological examination.
the immunoblotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western test), the sandwich immunoassay for PrPRes detection (short assay protocol) carried out following denaturation and concentration steps (Bio-Rad TeSeE SAP rapid test), the microplate-based immunoassay (ELISA) which detects Proteinase K-resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test), the immunoassay using a chemical polymer for selective PrPSc capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE Antigen Test Kit, EIA & HerdChek BSE-Scrapie Antigen (IDEXX Laboratories)), the lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Prionics Check PrioSTRIP), the two-sided immunoassay using two different monoclonal antibodies directed against two epitopes presented in a highly unfolded state of bovine PrPSc (Roboscreen Beta Prion BSE EIA Test Kit).
the sandwich immunoassay for PrPRes detection (short assay protocol) carried out following denaturation and concentration steps (Bio-Rad TeSeE SAP rapid test), the sandwich immunoassay for PrPRes detection with the TeSeE Sheep/Goat Detection kit carried out following denaturation and concentration steps with the TeSeE Sheep/Goat Purification kit (Bio-Rad TeSeE Sheep/Goat rapid test), the immunoassay using a chemical polymer for selective PrPSc capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (HerdChek BSE-Scrapie Antigen (IDEXX Laboratories)), the lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Prionics — Check PrioSTRIP SR, visual reading protocol).