Substituted by 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).

Deleted by Commission Regulation (EU) 2017/110 of 23 January 2017 amending Annexes IV 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).

Words in Annex 10 Ch. C point 4 omitted (31.12.2020) by virtue of The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/170), regs. 1, 2(74)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

Words in Annex 10 Ch. C point 4 omitted (31.12.2020) by virtue of The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/170), regs. 1, 2(74)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

Word in Annex 10 Ch. C point 4 substituted (31.12.2020) by The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/170), regs. 1, 2(74)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

Words in Annex 10 Ch. C point 4 omitted (31.12.2020) by virtue of The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/170), regs. 1, 2(74)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2020-12-31Regulation (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 encephalopathiesRegulation (EC) No 999/2001 of the European Parliament and of the CouncilRegulation (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 encephalopathiesKing's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02001R0999-20201119texttext/xmlen2024-05-19Expert Participation2020-12-31ANNEX XREFERENCE LABORATORIES, SAMPLING AND LABORATORY ANALYSIS METHODSCHAPTER C Sampling and laboratory testing 4. Rapid tests

For 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:

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).

For 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:

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)),

...

In all rapid tests, sample tissue on which the test must be applied must comply with the manufacturer's instructions for use.

Producers of rapid tests must have a quality assurance system in place that ... ensures that the test performance does not change. ...

Changes to rapid tests and to test protocols may only be made if the change does not alter the sensitivity, specificity or reliability of the rapid test. ...

This XML file does not appear to have any style information associated with it. The document tree is shown below.
<akomaNtoso xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xsi:schemaLocation="http://docs.oasis-open.org/legaldocml/ns/akn/3.0 http://docs.oasis-open.org/legaldocml/akn-core/v1.0/cos01/part2-specs/schemas/akomantoso30.xsd">
<portion includedIn="http://www.legislation.gov.uk/id/eur/2001/999/annex/X/chapter/C">
<meta>
<identification source="#source">
<FRBRWork>
<FRBRthis value="http://www.legislation.gov.uk/id/eur/2001/999/annex/X/chapter/C"/>
<FRBRuri value="http://www.legislation.gov.uk/id/eur/2001/999/annex/X/chapter/C"/>
<FRBRdate date="2001-05-22" name="adopted"/>
<FRBRauthor href="http://publications.europa.eu/resource/authority/corporate-body/OP_DATPRO"/>
<FRBRcountry value="EU"/>
<FRBRnumber value="999"/>
<FRBRname value="Regulation (EU) 2001/999"/>
<FRBRprescriptive value="true"/>
</FRBRWork>
<FRBRExpression>
<FRBRthis value="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2020-12-31"/>
<FRBRuri value="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/2020-12-31"/>
<FRBRdate date="2020-12-31" name="validFrom"/>
<FRBRauthor href="#source"/>
<FRBRlanguage language="eng"/>
</FRBRExpression>
<FRBRManifestation>
<FRBRthis value="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2020-12-31/data.akn"/>
<FRBRuri value="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/2020-12-31/data.akn"/>
<FRBRdate date="2024-11-11Z" name="transform"/>
<FRBRauthor href="http://www.legislation.gov.uk"/>
<FRBRformat value="application/akn+xml"/>
</FRBRManifestation>
</identification>
<lifecycle source="#source">
<eventRef date="2001-05-22" type="generation" eId="enacted-date" source="#source"/>
<eventRef date="2005-01-01" type="amendment" source="#source"/>
<eventRef date="2005-02-11" type="amendment" source="#source"/>
<eventRef date="2005-03-09" type="amendment" source="#source"/>
<eventRef date="2006-03-17" type="amendment" source="#source"/>
<eventRef date="2008-01-15" type="amendment" source="#source"/>
<eventRef date="2008-04-26" type="amendment" source="#source"/>
<eventRef date="2009-03-19" type="amendment" source="#source"/>
<eventRef date="2011-01-01" type="amendment" source="#source"/>
<eventRef date="2012-11-17" type="amendment" source="#source"/>
<eventRef date="2013-07-01" type="amendment" source="#source"/>
<eventRef date="2015-01-01" type="amendment" source="#source"/>
<eventRef date="2017-02-13" type="amendment" source="#source"/>
<eventRef date="2020-12-31" eId="effective-date-1" source="#source"/>
<eventRef date="2021-11-26" eId="effective-date-2" source="#source"/>
<eventRef date="2022-11-16" eId="effective-date-3" source="#source"/>
</lifecycle>
<analysis source="#source">
<passiveModifications>
<textualMod type="substitution" eId="mod-O039001M010">
<source href="#c000018"/>
<destination href="#annex-X"/>
</textualMod>
<textualMod type="substitution" eId="mod-key-1f5e6c13dace273fbfbf7dbd957a5992-1658497244944">
<source href="#key-1f5e6c13dace273fbfbf7dbd957a5992"/>
<destination href="#annex-X-chapter-C-division-4"/>
</textualMod>
</passiveModifications>
<restrictions source="#source">
<restriction refersTo="#e+w+s+ni" type="jurisdiction"/>
<restriction href="#d4e619" refersTo="#e+w+s+ni" type="jurisdiction"/>
<restriction href="#annex-X" refersTo="#e+w+s+ni" type="jurisdiction"/>
<restriction href="#annex-X-chapter-C" refersTo="#e+w+s+ni" type="jurisdiction"/>
<restriction href="#annex-X-chapter-C-division-4" refersTo="#e+w+s+ni" type="jurisdiction"/>
</restrictions>
</analysis>
<temporalData source="#source">
<temporalGroup eId="period1">
<timeInterval start="#effective-date-1" refersTo="#period-concept1"/>
</temporalGroup>
<temporalGroup eId="period2">
<timeInterval start="#effective-date-1" end="#effective-date-2" refersTo="#period-concept2"/>
</temporalGroup>
<temporalGroup eId="period3">
<timeInterval start="#effective-date-1" end="#effective-date-3" refersTo="#period-concept3"/>
</temporalGroup>
</temporalData>
<references source="#source">
<TLCOrganization eId="source" href="http://www.legislation.gov.uk/id/publisher/KingsOrQueensPrinterOfActsOfParliament" showAs="King's Printer of Acts of Parliament"/>
<passiveRef href="http://www.legislation.gov.uk/id/uksi/2019/588" showAs="The Animals (Legislative Functions) (EU Exit) Regulations 2019"/>
<passiveRef href="http://www.legislation.gov.uk/id/uksi/2020/1388" showAs="The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020"/>
<TLCLocation eId="e+w+s+ni" href="/ontology/jurisdictions/uk.EnglandWalesScotlandNorthernIreland" showAs="England, Wales, Scotland, Northern Ireland"/>
<TLCConcept eId="period-concept1" href="/ontology/time/2020.12.31" showAs="since 2020-12-31"/>
<TLCConcept eId="period-concept2" href="/ontology/time/2020.12.31-2021.11.26" showAs="from 2020-12-31 until 2021-11-26"/>
<TLCConcept eId="period-concept3" href="/ontology/time/2020.12.31-2022.11.16" showAs="from 2020-12-31 until 2022-11-16"/>
</references>
<notes source="#source">
<note class="commentary F" eId="c000018">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2014/1148">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)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000039">
<p>
Deleted by
<ref href="http://www.legislation.gov.uk/id/eur/2017/110">Commission Regulation (EU) 2017/110 of 23 January 2017 amending Annexes IV 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)</ref>
.
</p>
</note>
<note class="commentary F" eId="key-e6bb52d5f477aa94668da3afe9d31915">
<p>
Words in
<ref href="http://www.legislation.gov.uk/id/eur/2001/999/annex/X/chapter/C">Annex 10 Ch. C point 4</ref>
omitted (31.12.2020) by virtue of
<ref href="http://www.legislation.gov.uk/id/uksi/2019/170">The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/170)</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">regs. 1</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/74/a/i">2(74)(a)(i)</ref>
;
<ref href="http://www.legislation.gov.uk/id/ukpga/2020/1">2020 c. 1</ref>
,
<ref href="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</ref>
</p>
</note>
<note class="commentary F" eId="key-638af56b1641f4e60b8f74627bf73b99">
<p>
Words in
<ref href="http://www.legislation.gov.uk/id/eur/2001/999/annex/X/chapter/C">Annex 10 Ch. C point 4</ref>
omitted (31.12.2020) by virtue of
<ref href="http://www.legislation.gov.uk/id/uksi/2019/170">The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/170)</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">regs. 1</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/74/a/ii">2(74)(a)(ii)</ref>
;
<ref href="http://www.legislation.gov.uk/id/ukpga/2020/1">2020 c. 1</ref>
,
<ref href="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</ref>
</p>
</note>
<note class="commentary F" eId="key-1f5e6c13dace273fbfbf7dbd957a5992">
<p>
Word in
<ref href="http://www.legislation.gov.uk/id/eur/2001/999/annex/X/chapter/C">Annex 10 Ch. C point 4</ref>
substituted (31.12.2020) by
<ref href="http://www.legislation.gov.uk/id/uksi/2019/170">The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/170)</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">regs. 1</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/74/b/i">2(74)(b)(i)</ref>
;
<ref href="http://www.legislation.gov.uk/id/ukpga/2020/1">2020 c. 1</ref>
,
<ref href="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</ref>
</p>
</note>
<note class="commentary F" eId="key-b281c137c612bd6a34b9c5e2241d4098">
<p>
Words in
<ref href="http://www.legislation.gov.uk/id/eur/2001/999/annex/X/chapter/C">Annex 10 Ch. C point 4</ref>
omitted (31.12.2020) by virtue of
<ref href="http://www.legislation.gov.uk/id/uksi/2019/170">The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/170)</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">regs. 1</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/74/b/ii">2(74)(b)(ii)</ref>
;
<ref href="http://www.legislation.gov.uk/id/ukpga/2020/1">2020 c. 1</ref>
,
<ref href="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</ref>
</p>
</note>
</notes>
<proprietary xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:ukm="http://www.legislation.gov.uk/namespaces/metadata" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:dct="http://purl.org/dc/terms/" xmlns:atom="http://www.w3.org/2005/Atom" source="#source">
<ukl:RestrictStartDate value="2020-12-31"/>
<ukl:RestrictEndDate value="2021-11-26"/>
<dc:identifier>http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2020-12-31</dc:identifier>
<dc:title>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</dc:title>
<dct:alternative>Regulation (EC) No 999/2001 of the European Parliament and of the Council</dct:alternative>
<dc:description>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</dc:description>
<dc:publisher>King's Printer of Acts of Parliament</dc:publisher>
<dc:source>https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02001R0999-20201119</dc:source>
<dc:type>text</dc:type>
<dc:format>text/xml</dc:format>
<dc:language>en</dc:language>
<dc:modified>2024-05-19</dc:modified>
<dc:contributor>Expert Participation</dc:contributor>
<dct:valid>2020-12-31</dct:valid>
<atom:link rel="self" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2020-12-31/data.xml" type="application/xml"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/resources" href="http://www.legislation.gov.uk/eur/2001/999/resources" title="More Resources"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/act" href="http://www.legislation.gov.uk/eur/2001/999/2020-12-31" title="whole act"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/introduction" href="http://www.legislation.gov.uk/eur/2001/999/introduction/2020-12-31" title="introduction"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/signature" href="http://www.legislation.gov.uk/eur/2001/999/signature/2020-12-31" title="signature"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/body" href="http://www.legislation.gov.uk/eur/2001/999/body/2020-12-31" title="body"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/annexes" href="http://www.legislation.gov.uk/eur/2001/999/annexes/2020-12-31" title="annexes"/>
<atom:link rel="http://www.legislation.gov.uk/def/date/euexitday" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2020-01-31" title="2020-01-31"/>
<atom:link rel="http://www.legislation.gov.uk/def/date/euexitTransitionEnd" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2020-12-31" title="2020-12-31"/>
<atom:link rel="http://www.legislation.gov.uk/def/legislation/EffectsApplied" href="https://www.legislation.gov.uk/changes/applied/affected/eur/2001/999" title="Amended by UK"/>
<atom:link rel="alternate" type="application/rdf+xml" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2020-12-31/data.rdf" title="RDF/XML"/>
<atom:link rel="alternate" type="application/akn+xml" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2020-12-31/data.akn" title="AKN"/>
<atom:link rel="alternate" type="application/xhtml+xml" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2020-12-31/data.xht" title="HTML snippet"/>
<atom:link rel="alternate" type="text/html" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2020-12-31/data.htm" title="Website (XHTML) Default View"/>
<atom:link rel="alternate" type="text/csv" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2020-12-31/data.csv" title="CSV"/>
<atom:link rel="alternate" type="application/pdf" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2020-12-31/data.pdf" title="PDF"/>
<atom:link rel="alternate" type="application/akn+xhtml" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2020-12-31/data.html" title="HTML5 snippet"/>
<atom:link rel="http://purl.org/dc/terms/tableOfContents" hreflang="en" href="http://www.legislation.gov.uk/eur/2001/999/contents/2020-12-31" title="Table of Contents"/>
<atom:link rel="http://purl.org/dc/terms/replaces" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2017-02-13" title="2017-02-13"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2005-01-01" title="2005-01-01"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2005-02-11" title="2005-02-11"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2005-03-09" title="2005-03-09"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2006-03-17" title="2006-03-17"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2008-01-15" title="2008-01-15"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2008-04-26" title="2008-04-26"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2009-03-19" title="2009-03-19"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2011-01-01" title="2011-01-01"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2012-11-17" title="2012-11-17"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2013-07-01" title="2013-07-01"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2015-01-01" title="2015-01-01"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4/2017-02-13" title="2017-02-13"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/4" title="current"/>
<atom:link rel="up" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/2020-12-31" title="Annex X Chapter C"/>
<atom:link rel="prev" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/3/2020-12-31" title="Division; Annex X Chapter C Division 3"/>
<atom:link rel="prevInForce" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/3/2020-12-31" title="Division; Annex X Chapter C Division 3"/>
<atom:link rel="next" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/5/2020-12-31" title="Division; Annex X Chapter C Division 5"/>
<atom:link rel="nextInForce" href="http://www.legislation.gov.uk/eur/2001/999/annex/X/chapter/C/division/5/2020-12-31" title="Division; Annex X Chapter C Division 5"/>
<ukm:EUMetadata>
<ukm:DocumentClassification>
<ukm:DocumentCategory Value="euretained"/>
<ukm:DocumentMainType Value="EuropeanUnionRegulation"/>
<ukm:DocumentStatus Value="revised"/>
</ukm:DocumentClassification>
<ukm:Year Value="2001"/>
<ukm:Number Value="999"/>
<ukm:EURLexIdentifiers>
<ukm:Cellar Value="207ed244-291b-11eb-9d7e-01aa75ed71a1"/>
<ukm:CELEX Value="02001R0999-20201119"/>
</ukm:EURLexIdentifiers>
<ukm:EnactmentDate Date="2001-05-22"/>
<ukm:EURLexModified Date="2020-11-26T17:16:10Z"/>
<ukm:EURLexExtracted Date="2020-11-26T17:39:31Z"/>
<ukm:XMLGenerated Date="2020-12-11T20:27:01Z"/>
<ukm:XMLImported Date="2020-12-14T10:09:55Z"/>
<ukm:CreatedBy Label="Provisional data" URI="http://publications.europa.eu/resource/authority/corporate-body/OP_DATPRO"/>
<ukm:UnappliedEffects>
<ukm:UnappliedEffect AffectingClass="UnitedKingdomStatutoryInstrument" AffectingEffectsExtent="E+W+S+N.I." AffectingYear="2019" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/588" EffectId="key-a29fe8c8f0832b5472425d553333ddad" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" Row="66" RequiresApplied="false" AffectedNumber="999" URI="http://www.legislation.gov.uk/id/effect/key-a29fe8c8f0832b5472425d553333ddad" Modified="2022-07-29T11:32:18Z" AffectingProvisions="reg. 4(21)(a)(i)" Notes="This amendment not applied to legislation.gov.uk. S.I. 2019/588, reg. 4(21)(a)(i) substituted immediately before IP completion day by S.I. 2020/1463, regs. 1(2)(a), 6(3)(g)" AffectedYear="2001" AffectedProvisions="Annex 3 Ch. A Pt. 2 point 4" Comments="IP completion day" AffectedClass="EuropeanUnionRegulation" Type="words substituted" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectingNumber="588">
<ukm:AffectedTitle>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</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-III-chapter-A" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/III/chapter/A">Annex 3 Ch. A </ukm:Section>
<ukm:Section Ref="annex-III-chapter-A-part-2" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/III/chapter/A/part/2" FoundRef="annex-III-chapter-A">Pt. 2</ukm:Section>
point 4
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Animals (Legislative Functions) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-4-21-a-i" URI="http://www.legislation.gov.uk/id/uksi/2019/588/regulation/4/21/a/i">reg. 4(21)(a)(i)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:Savings>
<ukm:Section Ref="regulation-12" URI="http://www.legislation.gov.uk/id/uksi/2019/588/regulation/12">reg. 12</ukm:Section>
</ukm:Savings>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/588/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect Row="539" EffectId="key-c7d2e41171d2367e64ccab3bd05f8a3d" AffectedClass="EuropeanUnionRegulation" AffectedNumber="999" Modified="2022-07-29T11:32:18Z" AffectingClass="UnitedKingdomStatutoryInstrument" AffectingYear="2019" URI="http://www.legislation.gov.uk/id/effect/key-c7d2e41171d2367e64ccab3bd05f8a3d" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectedYear="2001" RequiresApplied="false" AffectedProvisions="Art. 23a(f)" Comments="IP completion day" Notes="This amendment not applied to legislation.gov.uk. S.I. 2019/588, reg. 4(16)(b) amended immediately before IP completion day by S.I. 2020/1463, regs. 1(2)(a), 6(3)(d)" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/588" Type="omitted" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectingEffectsExtent="E+W+S+N.I." AffectingNumber="588" AffectingProvisions="reg. 4(16)(b)">
<ukm:AffectedTitle>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</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-23a-f" URI="http://www.legislation.gov.uk/id/eur/2001/999/article/23a/f" FoundRef="article-23a">Art. 23a(f)</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Animals (Legislative Functions) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-4-16-b" URI="http://www.legislation.gov.uk/id/uksi/2019/588/regulation/4/16/b">reg. 4(16)(b)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:Savings>
<ukm:Section Ref="regulation-12" URI="http://www.legislation.gov.uk/id/uksi/2019/588/regulation/12">reg. 12</ukm:Section>
</ukm:Savings>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/588/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectedClass="EuropeanUnionRegulation" Notes="This amendment not applied to legislation.gov.uk. Operative words in reg. 2(2)(b) omitted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(a)(ii)(bb)" AffectedProvisions="Art. 3(1B)(c)" Modified="2023-02-28T19:30:52Z" AffectingNumber="1388" AffectingClass="UnitedKingdomStatutoryInstrument" AffectingProvisions="reg. 20(2)(a)(ii)(bb)" RequiresApplied="false" AffectingEffectsExtent="E+W+S+N.I." AffectedNumber="999" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectingYear="2020" AffectingURI="http://www.legislation.gov.uk/id/uksi/2020/1388" URI="http://www.legislation.gov.uk/id/effect/key-cac987a5cc8477fc669311b97c29e76d" AffectingTerritorialApplication="E+W+S" Row="960" EffectId="key-cac987a5cc8477fc669311b97c29e76d" Type="omitted in earlier amending S.I. 2019/170, reg. 2(2)(b)" Comments="IP completion day - art. 3(1B)(c) omitted prior to art. 3(1B) being inserted" AffectedYear="2001">
<ukm:AffectedTitle>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</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-3-1B-c" URI="http://www.legislation.gov.uk/id/eur/2001/999/article/3/1B/c" FoundRef="article-3">Art. 3(1B)(c)</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-20-2-a-ii-bb" URI="http://www.legislation.gov.uk/id/uksi/2020/1388/regulation/20/2/a/ii/bb" FoundRef="regulation-20">reg. 20(2)(a)(ii)(bb)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1-2-a" URI="http://www.legislation.gov.uk/id/uksi/2020/1388/regulation/1/2/a">reg. 1(2)(a)</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
</ukm:UnappliedEffects>
</ukm:EUMetadata>
<ukm:Alternatives>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_adopted_en.pdf" Date="2001-05-22" Size="311160"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2001-07-01_en.pdf" Date="2001-07-01" Size="202714" Revised="2001-07-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2001-10-01_en.pdf" Date="2001-10-01" Size="205056" Revised="2001-10-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2002-01-01_en.pdf" Date="2002-01-01" Size="213407" Revised="2002-01-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2002-03-01_en.pdf" Date="2002-03-01" Size="215816" Revised="2002-03-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2002-04-01_en.pdf" Date="2002-04-01" Size="210422" Revised="2002-04-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2002-08-25_en.pdf" Date="2002-08-25" Size="212357" Revised="2002-08-25"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2003-03-05_en.pdf" Date="2003-03-05" Size="214284" Revised="2003-03-05"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2003-10-01_en.pdf" Date="2003-10-01" Size="243052" Revised="2003-10-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2003-11-03_en.pdf" Date="2003-11-03" Size="244895" Revised="2003-11-03"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2003-11-05_en.pdf" Date="2003-11-05" Size="246819" Revised="2003-11-05"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2004-01-01_en.pdf" Date="2004-01-01" Size="244040" Revised="2004-01-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2004-05-01_en.pdf" Date="2004-05-01" Size="248791" Revised="2004-05-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2004-07-01_en.pdf" Date="2004-07-01" Size="249886" Revised="2004-07-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2005-01-01_en.pdf" Date="2005-01-01" Size="274694" Revised="2005-01-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2005-02-11_en.pdf" Date="2005-02-11" Size="283376" Revised="2005-02-11"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2005-03-09_en.pdf" Date="2005-03-09" Size="285822" Revised="2005-03-09"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2005-07-01_en.pdf" Date="2005-07-01" Size="285963" Revised="2005-07-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2005-09-01_en.pdf" Date="2005-09-01" Size="285137" Revised="2005-09-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2006-01-01_en.pdf" Date="2006-01-01" Size="279712" Revised="2006-01-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2006-03-17_en.pdf" Date="2006-03-17" Size="331137" Revised="2006-03-17"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2006-05-25_en.pdf" Date="2006-05-25" Size="331793" Revised="2006-05-25"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2006-07-09_en.pdf" Date="2006-07-09" Size="332945" Revised="2006-07-09"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2007-01-19_en.pdf" Date="2007-01-19" Size="302900" Revised="2007-01-19"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2007-07-17_en.pdf" Date="2007-07-17" Size="283293" Revised="2007-07-17"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2007-11-02_en.pdf" Date="2007-11-02" Size="285775" Revised="2007-11-02"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2008-01-15_en.pdf" Date="2008-01-15" Size="286230" Revised="2008-01-15"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2008-04-26_en.pdf" Date="2008-04-26" Size="294091" Revised="2008-04-26"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2008-07-10_en.pdf" Date="2008-07-10" Size="296251" Revised="2008-07-10"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2008-09-29_en.pdf" Date="2008-09-29" Size="296236" Revised="2008-09-29"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2008-10-20_en.pdf" Date="2008-10-20" Size="300824" Revised="2008-10-20"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2009-02-24_en.pdf" Date="2009-02-24" Size="311521" Revised="2009-02-24"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2009-03-19_en.pdf" Date="2009-03-19" Size="311551" Revised="2009-03-19"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2009-04-20_en.pdf" Date="2009-04-20" Size="314479" Revised="2009-04-20"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2011-01-01_en.pdf" Date="2011-01-01" Size="1167598" Revised="2011-01-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2011-03-18_en.pdf" Date="2011-03-18" Size="1170663" Revised="2011-03-18"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2012-11-17_en.pdf" Date="2012-11-17" Size="1193283" Revised="2012-11-17"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2013-06-01_en.pdf" Date="2013-06-01" Size="1221815" Revised="2013-06-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2013-07-01_en.pdf" Date="2013-07-01" Size="1273046" Revised="2013-07-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2015-01-01_en.pdf" Date="2015-01-01" Size="1283121" Revised="2015-01-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2015-05-27_en.pdf" Date="2015-05-27" Size="801414" Revised="2015-05-27"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2015-08-05_en.pdf" Date="2015-08-05" Size="802260" Revised="2015-08-05"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2016-02-03_en.pdf" Date="2016-02-03" Size="811736" Revised="2016-02-03"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2016-09-08_en.pdf" Date="2016-09-08" Size="908579" Revised="2016-09-08"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2017-02-13_en.pdf" Date="2017-02-13" Size="967121" Revised="2017-02-13"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2017-05-17_en.pdf" Date="2017-05-17" Size="925891" Revised="2017-05-17"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2017-07-01_en.pdf" Date="2017-07-01" Size="965621" Revised="2017-07-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2017-11-20_en.pdf" Date="2017-11-20" Size="999641" Revised="2017-11-20"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2018-01-01_en.pdf" Date="2018-01-01" Size="1023245" Revised="2018-01-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2018-07-30_en.pdf" Date="2018-07-30" Size="1002295" Revised="2018-07-30"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2019-01-01_en.pdf" Date="2019-01-01" Size="1054960" Revised="2019-01-01"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2019-03-20_en.pdf" Date="2019-03-20" Size="1016287" Revised="2019-03-20"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2019-07-17_en.pdf" Date="2019-07-17" Size="1124324" Revised="2019-07-17"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2019-12-14_en.pdf" Date="2019-12-14" Size="1104135" Revised="2019-12-14"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2020-07-02_en.pdf" Date="2020-07-02" Size="1178486" Revised="2020-07-02"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2001/999/pdfs/eur_20010999_2020-11-19_en.pdf" Date="2020-11-19" Size="1150675" Revised="2020-11-19"/>
</ukm:Alternatives>
<ukm:Statistics>
<ukm:TotalParagraphs Value="293"/>
<ukm:BodyParagraphs Value="29"/>
<ukm:ScheduleParagraphs Value="264"/>
<ukm:AttachmentParagraphs Value="0"/>
<ukm:TotalImages Value="0"/>
</ukm:Statistics>
</proprietary>
</meta>
<portionBody>
<hcontainer name="schedules" eId="d4e619" period="#period1">
<hcontainer name="schedule" eId="annex-X" period="#period3">
<num>
<ins class="substitution O039001M010 first">
<noteRef href="#c000018" marker="F1" class="commentary attribute F"/>
ANNEX X
</ins>
</num>
<heading>
<ins class="substitution O039001M010">REFERENCE LABORATORIES, SAMPLING AND LABORATORY ANALYSIS METHODS</ins>
</heading>
<chapter eId="annex-X-chapter-C" period="#period3">
<num>
<ins class="substitution O039001M010">CHAPTER C </ins>
</num>
<heading>
<strong>
<ins class="substitution O039001M010"> Sampling and laboratory testing </ins>
</strong>
</heading>
<level eId="annex-X-chapter-C-division-4" period="#period1">
<num>
<ins class="substitution O039001M010"> 4. </ins>
</num>
<heading>
<strong>
<ins class="substitution O039001M010"> Rapid tests </ins>
</strong>
</heading>
<content>
<p>
<ins class="substitution O039001M010"> For 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: </ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O039001M010"> the immunoblotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western test), </ins>
</p>
</item>
<item>
<p>
<ins class="substitution O039001M010"> the sandwich immunoassay for PrPRes detection (short assay protocol) carried out following denaturation and concentration steps (Bio-Rad TeSeE SAP rapid test), </ins>
</p>
</item>
<item>
<p>
<ins class="substitution O039001M010"> the microplate-based immunoassay (ELISA) which detects Proteinase K-resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test), </ins>
</p>
</item>
<item>
<p>
<ins class="substitution O039001M010"> 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)), </ins>
</p>
</item>
<item>
<p>
<ins class="substitution O039001M010"> the lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Prionics Check PrioSTRIP), </ins>
</p>
</item>
<item>
<p>
<ins class="substitution O039001M010"> 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). </ins>
</p>
</item>
</blockList>
<p>
<ins class="substitution O039001M010"> For 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: </ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O039001M010"> the sandwich immunoassay for PrPRes detection (short assay protocol) carried out following denaturation and concentration steps (Bio-Rad TeSeE SAP rapid test), </ins>
</p>
</item>
<item>
<p>
<ins class="substitution O039001M010"> 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), </ins>
</p>
</item>
<item>
<p>
<ins class="substitution O039001M010"> 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)), </ins>
</p>
</item>
<item>
<p>
<noteRef href="#c000039" marker="F2" class="commentary F"/>
<ins class="substitution O039001M010">... </ins>
</p>
</item>
</blockList>
<p>
<ins class="substitution O039001M010"> In all rapid tests, sample tissue on which the test must be applied must comply with the manufacturer's instructions for use. </ins>
</p>
<p>
<ins class="substitution O039001M010"> Producers of rapid tests must have a quality assurance system in place that </ins>
<noteRef href="#key-e6bb52d5f477aa94668da3afe9d31915" marker="F3" class="commentary F"/>
<ins class="substitution O039001M010">... ensures that the test performance does not change. </ins>
<noteRef href="#key-638af56b1641f4e60b8f74627bf73b99" marker="F4" class="commentary F"/>
<ins class="substitution O039001M010">... </ins>
</p>
<p>
<ins class="substitution O039001M010"> Changes to rapid tests and to test protocols may only be made </ins>
<ins class="substitution O039001M010">
<ins class="substitution key-1f5e6c13dace273fbfbf7dbd957a5992-1658497244944 first last">
<noteRef href="#key-1f5e6c13dace273fbfbf7dbd957a5992" marker="F5" class="commentary attribute F"/>
if
</ins>
</ins>
<ins class="substitution O039001M010"> the change does not alter the sensitivity, specificity or reliability of the rapid test. </ins>
<noteRef href="#key-b281c137c612bd6a34b9c5e2241d4098" marker="F6" class="commentary F"/>
<ins class="substitution O039001M010 last">... </ins>
</p>
</content>
</level>
</chapter>
</hcontainer>
</hcontainer>
</portionBody>
</portion>
</akomaNtoso>