{
  "url": "https://openlegislation.uk/eu-regulation-2014-1148/annex",
  "json_url": "https://openlegislation.uk/eu-regulation-2014-1148/annex.json",
  "legislation": "eur/2014/1148",
  "legislation_title": "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)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2014-1148",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "Annexes II, VII, VIII, IX and X to Regulation (EC) No 999/2001 are amended as follows:\n(1) Annex II is amended as follows:\n(a) Points 1 and 2 of Chapter B are replaced by the following:\n‘1.\nStructure of the risk analysis\nThe risk analyses shall comprise an entry assessment and an exposure assessment.\n2.\nEntry assessment (external challenge)\n2.1.\nThe 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.\nThe following risk factors shall be taken into account:\n(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;\n(b) the production of meat-and-bone meal or greaves from the BSE indigenous ruminant population;\n(c) imported meat-and-bone meal or greaves;\n(d) imported bovine and ovine and caprine animals;\n(e) imported animal feed and feed ingredients;\n(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;\n(g) imported products of ruminant origin for in vivo use in bovine animals.\n2.2.\nSpecial 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.’\n(b) In point 3 of Chapter D, Table 2 is replaced by the following:\n‘\nTable 2\nPoints targets for different adult bovine animals population sizes in a country or region\nPoints targets for country or region\nAdult bovine animals population size(24 months and older)\nType A surveillance\nType B surveillance\n> 1 000 000\n300 000\n150 000\n900 001-1 000 000\n214 600\n107 300\n800 001-900 000\n190 700\n95 350\n700 001-800 000\n166 900\n83 450\n600 001-700 000\n143 000\n71 500\n500 001-600 000\n119 200\n59 600\n400 001-500 000\n95 400\n47 700\n300 001-400 000\n71 500\n35 750\n200 001-300 000\n47 700\n23 850\n100 001-200 000\n22 100\n11 500\n90 001-100 000\n19 900\n9 950\n80 001-90 000\n17 700\n8 850\n70 001-80 000\n15 500\n7 750\n60 001-70 000\n13 000\n6 650\n50 001-60 000\n11 000\n5 500\n40 001-50 000\n8 800\n4 400\n30 001-40 000\n6 600\n3 300\n20 001-30 000\n4 400\n2 200\n10 001-20 000\n2 100\n1 050\n9 001-10 000\n1 900\n950\n8 001-9 000\n1 600\n800\n7 001-8 000\n1 400\n700\n6 001-7 000\n1 200\n600\n5 001-6 000\n1 000\n500\n4 001-5 000\n800\n400\n3 001-4 000\n600\n300\n2 001-3 000\n400\n200\n1 001-2 000\n200\n100\n’\n(2) In Annex VII, the first paragraph in point 2.2.1 of Chapter B is replaced by the following:\n‘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).’\n(3) In Annex VIII, Section A of Chapter A is amended as follows:\n(a) In point 1.2, paragraph (g) is replaced by the following:\n‘(g)\nonly the following ovine and caprine embryos/ova may be introduced:\n(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:\nthey are permanently identified to enable trace back to their holding of birth\nthey have been kept since birth in holdings in which no case of classical scrapie has been confirmed during their residency\nthey showed no clinical sign of classical scrapie at the time of embryo/ova collection;\n(ii) ovine embryos/ova carrying at least one ARR allele.’\n(b) In point 1.3, paragraph (g) is replaced by the following:\n‘(g)\nonly the following ovine and caprine embryos/ova may be introduced:\n(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:\nthey are permanently identified to enable trace back to their holding of birth\nthey have been kept since birth in holdings in which no case of classical scrapie has been confirmed during their residency\nthey showed no clinical sign of classical scrapie at the time of embryo/ova collection;\n(ii) ovine embryos/ova carrying at least one ARR allele.’\n(c) In point 2, the following point 3 is added:\n‘2.3.\nThe Member States or zone of the Member State with a negligible risk for classical scrapie are the following:\nAustria.’\n(d) Point 3.2 is replaced by the following:\n‘3.2.\nThe national scrapie control programmes of the following Member States are hereby approved:\nDenmark\nFinland\nSweden.’\n(e) In point 4.2, paragraph (e) is replaced by the following:\n‘(e)\nin the case of ovine embryos, be carrying at least one ARR allele.’\n(4) In Annex IX, point (ii) of point 2 of Chapter H is replaced by the following:\n‘(ii)\nin the case of ovine embryos, the embryos carry at least one ARR allele.’\n(5) Annex X is replaced by the following:\nANNEX X\nREFERENCE LABORATORIES, SAMPLING AND LABORATORY ANALYSIS METHODS\nCHAPTER A\nNational reference laboratories\n1.. The designated national reference laboratory is to:\n(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;\n(b) verify diagnostic methods used in official diagnostic laboratories;\n(c) be responsible for coordination of diagnostic standards and methods within the Member State. To this end, it:\nmay provide diagnostic reagents to official diagnostic laboratories;\nis to control the quality of all diagnostic reagents used in the Member State\nis to periodically arrange comparative tests\nis 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\nis to ensure confirmation of results obtained in diagnostic laboratories;\n(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.\n2.. 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.\n3.. The national reference laboratories are:\nAustria:\nAgentur für Gesundheit und Ernährungssicherheit GmbH (AGES) Institut für veterinärmedizinische Untersuchungen\nRobert Koch Gasse 17\nA-2340 Mödling\nBelgium:\nCERVA-CODA-VAR\nCentre d'Étude et de Recherches Vétérinaires et Agrochimiques, Centrum voor Onderzoek in Diergeneeskunde en Agrochemie, Veterinary and Agrochemical Research Centre\nGroeselenberg 99\nB-1180 Bruxelles\nBulgaria:\nНационален диагностичен научноизследователски ветеринарномедицински институт ‘Проф. Д-р Георги Павлов’\nНационална референтна лаборатория ‘Tрансмисивни спонгиформни енцефалопатии’\nбул. ‘Пенчо Славейков’ 15\nСофия 1606\n(National Diagnostic Veterinary Research Institute “Prof. Dr Georgi Pavlov”, National Reference Laboratory for Transmissible Spongiform Encephalopathies, 15 Pencho Slaveykov Blvd., 1606 Sofia)\nCroatia:\nHrvatski veterinarski institut,\nSavska Cesta 143\n10000 Zagreb\nCyprus:\nState Veterinary Laboratories\nVeterinary Services\nCY-1417 Athalassa\nNicosia\nCzech Republic:\nStátní veterinární ústav Jihlava (State Veterinary Institute Jihlava)\nNational Reference Laboratory for BSE and Animal TSEs\nRantířovská 93\n586 05 Jihlava\nDenmark:\nVeterinærinstituttet\nDanmarks Tekniske Universitet\nBülowsvej 27\nDK-1870 Frederiksberg C\n(National Veterinary Institute, Technical University of Denmark, 27, Bülowsvej, DK — 1870 Frederiksberg C)\nEstonia:\nVeterinaar- ja Toidulaboratoorium (Estonian Veterinary and Food Laboratory)\nKreutzwaldi 30\nTartu 51006\nFinland:\nFinnish Food Safety Authority Evira\nResearch and Laboratory Department\nVeterinary Virology Research Unit- TSEs\nMustialankatu 3\nFI-00790 Helsinki\nFrance:\nANSES-Lyon, Unité MND\n31, avenue Tony Garnier\n69 364 LYON Cedex 07\nGermany:\nFriedrich-Loeffler-Institut\nInstitute for Novel and Emerging Infectious Diseases at the Friederich-Loeffler-Institut\nFederal Research Institute for Animal Health\nSuedufer 10\nD-17493 Greifswald Insel Riems\nGreece:\nMinistry of Agriculture — Veterinary Laboratory of Larissa\n6th km of Larissa — Trikala Highway\nGR-41110 Larissa\nHungary:\nVeterinary Diagnostic Directorate, National Food Chain Safety Office (VDD NFCSO)\nTábornok u. 2\n1143 Budapest\nIreland:\nCentral Veterinary Research Laboratory\nDepartment of Agriculture, Food and the Marine\nBackweston Campus\nCelbridge\nCo. Kildare\nItaly:\nIstituto Zooprofilattico Sperimentale del Piemonte, Liguria e Valle d'Aosta — CEA\nVia Bologna, 148\nI-10154 Torino\nLatvia:\nInstitute of Food Safety, Animal Health and Environment (BIOR)\nLejupes Str. 3\nRiga LV 1076\nLithuania:\nNational Food and Veterinary Risk Assessment Institute\nJ. Kairiūkščio str. 10\nLT-08409 Vilnius\nLuxembourg:\nCERVA-CODA-VAR\nCentre d'Étude et de Recherches Vétérinaires et Agrochimiques, Centrum voor Onderzoek in Diergeneeskunde en Agrochemie, Veterinary and Agrochemical Research Centre\nGroeselenberg 99\nB-1180 Bruxelles\nMalta:\nVeterinary Diagnostic Laboratory\nDepartment of Food Health and Diagnostics\nVeterinary Affairs and Fisheries Division\nMinistry for Rural Affairs and the Environment\nAlbert Town Marsa\nNetherlands:\nCentral Veterinary Instutute of Wageningen UR\nEdelhertweg 15\n8219 PH Lelystad\nP.O. Box 2004\nNL-8203 AA Lelystad\nPoland:\nPaństwowy Instytut Weterynaryjny (PIWet)\n24-100 Puławy\nal. Partyzantów 57\nPortugal:\nSetor diagnóstico EET\nLaboratório de Patologia\nUnidade Estratégica de Investigação e Serviços de Produção e Saúde Animal\nInstituto Nacional de Investigação Agrária e Veterinária Rua General Morais Sarmento\n1500-311 Lisboa\nRomania:\nInstitutul de Diagnostic și Sănătate Animală (Institute for Diagnosis and Animal Health)\nDepartment of Morphology\nStrada Dr Staicovici nr. 63, 5\nBucurești 050557\nSlovakia:\nState Veterinary Institute Zvolen\nPod dráhami 918\nSK-960 86, Zvolen\nSlovenia:\nUniversity of Ljubljana, Veterinary faculty\nNational Veterinary Institute\nGerbičeva 60\nSI-1000 Ljubljana\nSpain:\nLaboratorio Central de Veterinaria (Algete)\nCtra. M-106 pk 1,4\n28110 Algete (Madrid)\nSweden:\nNational Veterinary Institute\nS-751 89 Uppsala\nUnited Kingdom:\nAnimal Health and Veterinary Laboratories Agency\nWoodham Lane\nNew Haw, Addlestone, Surrey KT15 3NB\nCHAPTER B\nEU reference laboratory\n1.. The EU reference laboratory for TSEs is:\nThe Animal Health and Veterinary Laboratories Agency\nWoodham Lane\nNew Haw\nAddlestone\nSurrey KT15 3NB\nUnited Kingdom\n2.. The functions and duties of the EU reference laboratory are:\n(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:\nstoring 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\nsupplying standard sera and other reference reagents to the national reference laboratories in order to standardise the tests and reagents used in the Member States\nbuilding up and retaining a collection of corresponding tissues containing the agents and strains of TSEs\norganising 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\ncollecting and collating data and information on the methods of diagnosis used and the results of tests carried out in the EU\ncharacterising isolates of the TSE agent by the most up-to-date methods to allow greater understanding of the epidemiology of the disease\nkeeping abreast of trends in surveillance, epidemiology and prevention of TSEs throughout the world\nmaintaining expertise on prion diseases to enable rapid differential diagnosis\nacquiring a thorough knowledge of the preparation and use of diagnostic methods used to control and eradicate TSEs;\n(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;\n(c) to facilitate the training or retraining of experts in laboratory diagnosis with a view to the harmonisation of diagnostic techniques throughout the EU.\nCHAPTER C\nSampling and laboratory testing\n1.\nSampling\nAny 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 World Organisation for Animal Health (OIE) (the Manual). In addition to, 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 EU reference laboratory.\nIn particular the competent authority shall collect the appropriate tissues, according to the available scientific advice and the guidelines of the EU 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 subject to confirmatory testing, and be processed subsequently in accordance with the EU reference laboratory guidelines on discriminatory testing and classification — “TSE strain characterisation in small ruminants: A technical handbook for National Reference Laboratories in the EU”.\nThe samples shall be correctly marked as to the identity of the sampled animal.\n2.\nLaboratories\nAny laboratory examination for TSE shall be carried out in official diagnostic laboratories designated for that purpose by the competent authority.\n3.\nMethods and protocols\n3.1.\nLaboratory testing for the presence of BSE in bovine animals\n(a)\nSuspect cases\nSamples from bovine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall immediately be subjected to confirmatory examinations using at least one of the following methods and protocols laid down in the latest edition of the Manual:\n(i) the immunohistochemical (IHC) method;\n(ii) Western blot;\n(iii) the demonstration of characteristic fibrils by electron microscopy;\n(iv) histopathological examination;\n(v) the combination of rapid tests as laid down in the third subparagraph.\nIf the histopathological examination is inconclusive or negative, the tissues shall be submitted to a further examination by one of the other confirmatory methods and protocols.\nRapid tests may be used for both primary screening of suspect cases and, if inconclusive or positive, for subsequent confirmation, according to the guidelines from the EU reference laboratory — “OIE rules for the official confirmation of BSE in bovines (based on an initial reactive result in an approved rapid test) by using a second rapid test”, and provided that:\n(i) the confirmation is carried out in a national reference laboratory for TSEs; and\n(ii) one of the two rapid tests is a Western blot; and\n(iii) the second rapid test used:\nincludes a negative tissue control and a bovine BSE sample as positive tissue control,\nis of a different type than the test used for the primary screening; and\n(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\n(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.\nIf the result of one of the confirmatory examinations referred to in points (i) to (v) of the first subparagraph is positive, the animal shall be regarded as a positive BSE case.\n(b)\nBSE monitoring\nSamples from bovine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part I shall be examined by a rapid test.\nWhen the result of the rapid test is inconclusive or positive, the sample shall immediately be subjected to confirmatory examinations using at least one of the following methods and protocols laid down in the latest edition of the Manual:\n(i) the immunohistochemical (IHC) method;\n(ii) Western blot;\n(iii) the demonstration of characteristic fibrils by electron microscopy;\n(iv) histopathological examination;\n(v) the combination of rapid tests as laid down in the fourth subparagraph.\nWhere the histopathological examination is inconclusive or negative, the tissues shall be submitted to a further examination by one of the other confirmatory methods and protocols.\nRapid tests may be used for both primary screening and, if inconclusive or positive, for subsequent confirmation, according to the guidelines from the EU reference laboratory — “OIE rules for the official confirmation of BSE in bovines (based on an initial reactive result in an approved rapid test) by using a second rapid test”, and provided that:\n(i) the confirmation is carried out in a national reference laboratory for TSEs; and\n(ii) one of the two rapid tests is a Western blot; and\n(iii) the second rapid test used:\nincludes a negative tissue control and a bovine BSE sample as positive tissue control,\nis of a different type than the test used for the primary screening; and\n(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\n(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.\nAn animal shall be regarded a positive BSE case if the result of the rapid test is inconclusive or positive, and at least one of the confirmatory examinations referred to in points (i) to (v) of the second subparagraph is positive.\n(c)\nFurther examination of positive BSE cases\nSamples from all positive BSE cases shall be forwarded to a laboratory, appointed by the competent authority, which has participated successfully in the latest proficiency testing organised by the EU reference laboratory for discriminatory testing of confirmed BSE cases, where they shall be further tested in accordance with the methods and protocols laid down in the EU reference laboratory's method for the classification of bovine TSE isolates (a two-blot method for the provisional classification of bovine TSE isolates).\n3.2.\nLaboratory testing for the presence of TSE in ovine and caprine animals\n(a)\nSuspect cases\nSamples from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall immediately be subjected to confirmatory examinations using at least one of the following methods and protocols laid down in the latest edition of the Manual:\n(i) the immunohistochemical (IHC) method;\n(ii) Western blot;\n(iii) the demonstration of characteristic fibrils by electron microscopy;\n(iv) histopathological examination.\nIn case the histopathological examination is inconclusive or negative, the tissues shall be submitted to a further examination by one of the other confirmatory methods and protocols.\nRapid tests may be used for primary screening of suspect cases. Such tests may not be used for subsequent confirmation.\nWhere the result of the rapid test used for primary screening of suspect cases is positive or inconclusive, the sample shall be subjected to an examination by one of the confirmatory examinations referred to in points (i) to (iv) of the first subparagraph. Where the histopathological examination is used for that purpose, but proves to be inconclusive or negative, the tissues shall be submitted to a further examination by one of the other confirmatory methods and protocols.\nIf the result of one of the confirmatory examinations referred to in points (i) to (iv) of the first subparagraph is positive, the animal shall be regarded as a positive TSE case and further examination as referred to in point (c) shall be performed.\n(b)\nTSE monitoring\nSamples 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, in order to ensure the detection of all known strains of TSE.\nWhen 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 histopathology, immunohistochemistry, Western blotting or demonstration of characteristic fibrils by electron microscopy, as referred to in point (a). If the result of the confirmatory examination is negative or inconclusive, the tissues shall be submitted to a further examination by immunohistochemistry or Western blotting.\nIf the result of one of the confirmatory examinations is positive, the animal shall be regarded as a positive TSE case and further examination as referred to in point (c) shall be performed.\n(c)\nFurther examination of positive TSE cases\n(i)\nPrimary molecular testing with a discriminatory Western blotting method\nSamples 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 TSE cases but which are not atypical 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 examined using a discriminatory Western blotting method listed in the guidelines of the EU reference laboratory by an official diagnostic laboratory designated by the competent authority, which has participated successfully in the latest proficiency testing organised by the EU reference laboratory for the use of such a method.\n(ii)\nSecondary molecular testing with additional molecular testing methods\nTSE cases in which the presence of BSE cannot be excluded according to the guidelines issued by the EU reference laboratory by the primary molecular testing referred to in point (i), shall be referred immediately to the EU reference laboratory, with all the relevant information available. The samples shall be submitted to further investigation and confirmation by at least one alternative method, differing immunochemically from the original primary molecular method, depending on the volume and nature of the referred material, as described in the guidelines of the EU reference laboratory. These additional tests will be carried out in the following laboratories approved for the relevant method:\nAgence Nationale de Sécurité Sanitaire de l'alimentation, de l'environnement et du travail\n31, avenue Tony Garnier\nBP 7033\nF-69342 Lyon Cedex\nCommissariat à l'Energie Atomique\n18, route du Panorama\nBP 6\nF-92265 Fontenay-aux-Roses Cedex\nAnimal Health and Veterinary Laboratories Agency\nWoodham Lane\nNew Haw\nAddlestone\nSurrey KT15 3NB\nUnited Kingdom\nThe results shall be interpreted by the EU reference laboratory assisted by a panel of experts referred to as the Strain Typing Expert Group (STEG), including a representative of the relevant national reference laboratory. The Commission shall be informed immediately about the outcome of that interpretation.\n(iii)\nMouse bioassay\nSamples indicative of BSE or inconclusive for BSE, following secondary molecular testing, shall be further analysed by mouse bioassay for final confirmation. The nature or quantity of available material may influence the bioassay design, which will be approved by the EU reference laboratory assisted by the STEG on a case by case basis. Bioassays will be performed by the EU reference laboratory, or by laboratories designated by the EU reference laboratory.\nThe results shall be interpreted by the EU reference laboratory assisted by the STEG. The Commission shall be informed immediately about the outcome of that interpretation.\n3.3.\nLaboratory testing for the presence of TSEs in species other than those referred to in points 3.1 and 3.2\nWhere 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 immunohistochemistry, Western 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 with positive results shall be carried out in the event of the first appearance of the disease.\nIn particular, where BSE is suspected in a species other than bovine animals, the cases shall be referred to the EU reference laboratory assisted by the STEG for further characterisation.\n4.\nRapid tests\nFor the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), only the following methods shall be used as rapid tests for the monitoring of BSE in bovine animals:\nthe immunoblotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western test),\nthe sandwich immunoassay for PrPRes detection (short assay protocol) carried out following denaturation and concentration steps (Bio-Rad TeSeE SAP rapid test),\nthe microplate-based immunoassay (ELISA) which detects Proteinase K-resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test),\nthe 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)),\nthe lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Prionics Check PrioSTRIP),\nthe 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).\nFor the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), only the following methods shall be used as rapid tests for the monitoring of TSE in ovine and caprine animals:\nthe sandwich immunoassay for PrPRes detection (short assay protocol) carried out following denaturation and concentration steps (Bio-Rad TeSeE SAP rapid test),\nthe 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),\nthe 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)),\nthe lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Prionics — Check PrioSTRIP SR, visual reading protocol).\nIn all rapid tests, sample tissue on which the test must be applied must comply with the manufacturer's instructions for use.\nProducers of rapid tests must have a quality assurance system in place that has been approved by the EU reference laboratory and ensures that the test performance does not change. Producers must provide the EU reference laboratory with the test protocols.\nChanges to rapid tests and to test protocols may only be made after prior notification to the EU reference laboratory and provided that the EU reference laboratory 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.\n5.\nAlternative tests\n(To be defined)",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2014/1148/annex",
    "retrieved_at": "2026-11-01T14:47:11.350905+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}