2001R0999—EN—01.01.2002—003.001—1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B REGULATION (EC) No 999/2001 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL
of22May2001
layingdownrulesfortheprevention,controlanderadication ofcertain transmissiblespongiform
encephalopathies
(OJL147,31.5.2001,p.1)
Amendedby:
OfficialJournal
No page date
►M1CommissionRegulation(EC)No1248/2001of22June2001 L173 12 27.6.2001
►M2CommissionRegulation(EC)No1326/2001of29June2001 L177 60 30.6.2001
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REGULATION(EC)No999/2001OFTHEEUROPEANPARLIA-
MENTANDOFTHECOUNCIL
of22May2001
laying down rules for the prevention, control and eradication of
certain transmissiblespongiformencephalopathies
THEEUROPEANPARLIAMENTANDTHECOUNCILOFTHE
EUROPEANUNION,
HavingregardtotheTreatyestablishingtheEuropeanCommunity,and
inparticularArticle152(4)(b)thereof,
HavingregardtotheproposalfromtheCommission(1),
Having regard to the opinion of the Economic and Social
Committee(2),
HavingconsultedtheCommitteeoftheRegions,
Acting in accordance with the procedure laid down in Article 251 of
theTreaty(3),
Whereas:
(1)Several distinct transmissible spongiform encephalopathies
(TSEs)haveforanumberofyearsbeenrecognisedasoccurringseparately in humans and animals. Bovine spongiform encepha-
lopathy (BSE) was first recognised in bovine animals in 1986
andinthefollowingyearswasrecognised asoccurring inotherspecies of animal. A new variant of Creutzfeldt-Jakob Disease(CJD) was described in 1996. Evidence continues to grow ofthesimilaritybetweentheBSEagentandthatofthenewvariantofCreutzfeld-JakobDisease.
(2)Since 1990the Community hasadopted a seriesofmeasures toprotect human and animal health from the risk of BSE. Those
measureshavebeenbasedonthesafeguardprovisionsofDirec-
tivesonanimal-healthmeasures.Itisappropriate,inviewofthemagnitude of the risk posed to human and animal health bycertainTSEs,toadoptspecificrulesfortheirprevention,controlanderadication.
(3)ThisRegulationdirectlyconcernspublichealthandisrelevanttothe functioning of the internal market. It covers products whichareincludedinAnnexItotheTreatyaswellasproductswhich
are not. Consequently, it is appropriate to choose Article
152(4)(b)oftheTreatyasthelegalbasis.
(4)The Commission has obtained scientific opinions, in particularfrom the Scientific Steering Committee and the ScientificCommittee on Veterinary Measures relating to Public Health,on several aspects of TSEs. Those opinions include advice onmeasures to reduce the potential risk for humans and animals
resultingfromexposuretoinfectedanimalproducts.
(5)These rules should apply to the production and placing on themarket ofliveanimals andproductsofanimal origin.However,
it is not necessary for them to apply to cosmetic or medicinalproducts, medical devices or their starting materials or inter-mediate products, for which other specific rules, in particularon the non-use of specified risk material, apply. Nor shouldthey apply to products of animal origin which do not pose a
risk to animal or human health since they are intended for
purposes other than the production of food, feed or fertiliser. Itisappropriate to ensure that products ofanimal origin excluded2001R0999—EN—01.01.2002—003.001—2
(1) OJC45,19.2.1999,p.2and
OJC120E,24.4.2001,p.89.
(2) OJC258,10.9.1999,p.19.
(3) Opinionofthe EuropeanParliament of17May2000(OJC59,23.2.2001,
p. 93), Common Position of the Council of 12 February 2001 (OJ C 88,
19.3.2001,p.1)andDecisionoftheEuropeanParliamentof3May2001.
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fromthe scope of this Regulation are kept separate fromthose
coveredbyitunlesstheymeetatleastthesamehealthstandardsasthelatter.
(6)ProvisionshouldbemadeforsafeguardmeasurestobetakenbytheCommissionincaseswhereariskfromaTSEhasnotbeenadequately addressed by the competent authority of a MemberStateorthirdcountry.
(7)A procedure should be established for the determination of theepidemiological status of a Member State, a third country and
of one of their regions, hereinafter referred to as ‘countries or
regions’withrespecttoBSE,onthebasisoftheincidentpropa-gation and human exposure risk, using information available.Member States and third countries which choose not to applyfor their status to be determined should be classified in a cate-gory by the Commission on the basis of all the information
availabletoit.
(8)Member States should institute education programmes for those
involved in the prevention and control of TSEs, as well as forveterinarians,farmersandworkersinvolvedinthetransportation,marketingandslaughteroffarmanimals.
(9)MemberStatesshouldcarryoutanannualprogrammeformoni-
toring BSE and scrapie and should inform the Commission and
theother Member Statesofthe resultsandofthe emergence ofanyotherTSE.
(10)Certain ruminant tissues should be designated as specified riskmaterialonthebasisofthepathogenesisofTSEsandtheepide-miological statusofthecountryorregionoforiginorresidence
of the animal concerned. The specified risk material should be
removed and disposed of in a manner which avoids any risk tohumanoranimalhealth.Inparticular,itshouldnotbeplacedonthe market to be used in the production of food, feed or ferti-liser. However, provision should be made for an equivalentlevelofhealthprotectionbymeansofascreeningtestforTSEs
carried out on individual animals as soon as it has been fully
validated.Slaughtertechniquespresentingariskofcausingbrainmaterial tocontaminate othertissuesshouldnotbepermitted incountries or regions other than those presenting the lowest riskofBSE.
(11)MeasuresshouldbetakentopreventthetransmissionofTSEsto
humans or animals by prohibiting the feeding of certain cate-
gories of animal protein to certain categories of animal, and byprohibiting the useofcertain ruminant materials infood.Thoseprohibitionsshouldbeproportionatetotherisksinvolved.
(12)The suspected presence of any TSE in any animal should benotified to the competent authority, which should immediately
take all appropriate measures, including placing the suspect
animal under movement restrictions while awaiting the resultsoftheinvestigationorhavingitslaughteredunderofficialsuper-vision.Ifthe competent authority cannot exclude the possibilityof a TSE, it should have the appropriate investigations carriedoutandshouldkeepthecarcasseunderofficialsupervisionuntil
adiagnosishasbeenmade.
(13)In the event of official confirmation of the presence of a TSE,
the competent authority should take all the necessary measures,includinghavingthecarcassedestroyed,carryingoutaninvesti-gation in order to identify all animals at risk and placingmovementrestrictionsontheanimalsandtheproductsofanimal
origin identified as such. Owners should be compensated, as
soonaspossible,forthelossofanimalsandproductsofanimalorigindestroyedpursuanttothisRegulation.
(14)Member States should draw up contingency plans for thenationalmeasurestobeimplementedintheeventofanoutbreakof BSE. Those plans should be approved by the Commission.2001R0999—EN—01.01.2002—003.001—3
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Provision should be made for extending this provision to TSEs
otherthanBSE.
(15)Provisions should be laid down covering the placing on themarket of certain live animals and products of animal origin.Existing Community rules on the identification and registrationof bovine animals provide for a system enabling the animals tobetracedbacktothedamandherdoforigininaccordancewithinternational standards. Equivalent guarantees should be
provided forbovine animals imported from third countries. The
animals and products of animal origin covered by Communityrules, moving in intra-Community trade or imported from thirdcountries,shouldbeaccompaniedbythecertificatesrequiredbythe said rules, supplemented as appropriate in accordance with
thisRegulation.
(16)The placing on the market of certain products of animal origin
derived frombovine anim als in high risk regions should beprohibited.However,thatprohibitionshouldnotapplytocertainproducts of animal origin produced under controlled conditionsfrom animals which can be demonstrated not to pose a high
riskofinfectionwithaTSE.
(17)It is necessary, in order to ensure that the rules concerning the
prevention, control and eradication of TSEs are observed, forsamples to be taken for laboratory testing on the basis of anestablished protocol which would give a full epidemiological
picture of the situation as regards TSE. In order to guarantee
uniformtestingproceduresandresults,nationalandCommunityReferenceLaboratoriesandreliablescientificmethods,includingrapid tests specifically for TSEs, should be established. Rapidtestsshouldbeusedasfaraspossible.
(18)Community inspections should be carried out in the MemberStatesinordertoensureuniformimplementation oftherequire-ments concerning the prevention, control and eradication ofTSEsandprovisionshouldalsobemadefortheimplementationofauditprocedures.Inordertoensurethatguaranteesequivalenttothoseapplied bythe Community are providedbythird coun-
tries upon import into the Community of live animals and
products of animal origin, Community on-the-spot inspectionsandauditsshouldbecarriedoutinordertoverifythattheimportconditionsaremetbyexportingthirdcountries.
(19)TrademeasuresforTSEsshouldbebasedoninternational stan-
dards, guidelines or recommendations, where they exist.
However, scientifically justified measures resulting in a higherlevel of health protection may be adopted if measures based onthe relevant international standards, guidelines or recommenda-tions would not achieve the appropriate level of health
protection.
(20)This Regulation should be re-examined as new scientific infor-
mationbecomesavailable.
(21)The necessary transitional measures in particular for regulatingthe use of specified risk material should be provided for in the
frameworkofthisRegulation.
(22)The measures necessary for the implementation of this Regula-
tion should be adopted in accordance with Council Decision1999/468/EC of 28 June 1999 laying down the procedure fortheexercise ofimplementing powersconferred onthe Commis-sion(
1).
(23)InordertoimplementthisRegulation,proceduresshouldbelaiddown establishing close and effective cooperation between theCommission and the Member States within the Standing Veter-inaryCommittee,theStandingCommitteeonFeedingstuffs,andtheStandingCommitteeonFoodstuffs.2001R0999—EN—01.01.2002—003.001—4
(1) OJL184,17.7.1999,p.23.
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(24)GiventhattheprovisionsfortheimplementationofthisRegula-
tion are general measures within the meaning of Article 2 of
Decision 1999/468/EC, they should be adopted in accordancewith the regulatory procedure laid down in Article 5 of thatDecision,
HAVEADOPTEDTHISREGULATION:
CHAPTERI
GENERALPROVISIONS
Article 1
Scope
1. This Regulation lays down rules for the prevention, control and
eradication of transmissible spongiform encephalopathies (TSEs) in
animals. Itshall apply to the production andplacing onthemarket of
liveanimalsandproductsofanimaloriginandincertainspecificcasestoexportsthereof.
2. ThisRegulationshallnotapplyto:
(a) cosmetic or medicinal products or medical devices, or to their
startingmaterialsorintermediateproducts;
(b) products which are not intended for use in human food, animal
feed or fertilisers, or to their starting materials or intermediateproducts;
(c) products of animal origin intended for exhibition, teaching, scien-
tific research, special studies or analysis, provided those products
are not eventually consumed or used by humans or by animals
otherthanthosekeptfortheresearchprojectsconcerned;
(d) liveanimalsusedinorintendedforresearch.
Article 2
Separationoflive animalsandofproductsofanimalorigin
In order to avoid cross-contamination or substitution between the live
animals or of the products of animal origin referred to in Article 1(1)andtheproductsofanimaloriginreferredtoinArticle1(2)(a),(b)and(c),ortheliveanimalsreferredtoinArticle1(2)(d),theyshallbekept
separate at all times unless such live animals or products of animal
originareproducedunderatleastthesameconditionsofhealthprotec-tioninrespectofTSEs.
Rulesfortheimplementation ofthisArticleshallbeadoptedinaccor-
dancewiththeprocedurereferredtoinArticle24(2).
Article 3
Definitions
1. ForthepurposesofthisRegulationthefollowingdefinitionsshall
apply:
(a) TSEs: all transmissible spongiform encephalopathies with the
exceptionofthoseoccurringinhumans;
(b) placing on the market: any operation the purpose of which is to
sell live animals or products of animal origin covered by thisRegulation to a third party in the Community, or any other formof supply against payment or free of charge to such a third partyorstoragewithaviewtosupplytosuchathirdparty;2001R0999—EN—01.01.2002—003.001—5
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(c) productsofanimalorigin:anyproductderivedfromorcontaining
a product derived fromany anim al covered by the provisions ofDirective89/662/EEC(
1)orDirective90/425/EEC(2);
(d) starting materials: raw materials or any other product of animal
origin out of which, or with the help of which, the products
referredtoinArticle1(2)(a)and(b)areproduced;
(e) competent authority: the central authority of a Member State
competent to ensure compliance with the requirements of this
Regulation or any authority to which that central authority has
delegatedthatcompetence,inparticularforthecontroloffeeding-stuffs; it shall also include, where appropriate, the correspondingauthorityofathirdcountry;
(f) category:oneoftheclassificationcategoriesreferredtoinChapter
CofAnnexII;
(g) specified risk material: the tissues specified in Annex V; unless
otherwise indicated, it does not include products containing orderivedfromthosetissues;
(h) animal suspectedofbeinginfected byaTSE:live,slaughtered or
dead animals, which show or have shown neurological or beha-vioural disorders or a progressive deterioration of the generalcondition linked to impairment of the central nervous system andforwhichtheinformationgatheredonthebasisofaclinicalexam-ination, response to treatment, a post-mortem examination or an
anteorpost-mortemlaboratoryanalysisdonotallowanalternative
diagnosis to be established. Bovine spongiformencephalopathies(BSE) shall be suspected in bovine animals which have producedapositiveresultfromarapidtestspecificallyforBSE;
(i) holding: any place in which animals covered by this Regulation
areheld,kept,bred,handledorshowntothepublic;
(j) sampling: the taking of samples, ensuring a statistically correct
representation, from animals or their environment, or fromproductsofanimalorigin,forthepurposeofestablishingadiseasediagnosis,familialrelationships,forhealthsurveillance, orforthemonitoring of the absence of microbiological agents or of certain
materialsinproductsofanimalorigin;
(k) fertilisers: any substance containing products of animal origin
utilised on land to enhance growth of vegetation; it may include
digestionresiduesfrombio-gasproductionorcomposting;
(l) rapid tests: the analysis methods referred to in Annex X,Chapter
C,point4,andforwhichtheresultsareknownwithin24hours;
(m) alternativetest:thetestsreferredtoinArticle8(2)whichareused
asanalternativetothewithdrawalofspecifiedriskmaterial.
2. ThespecificdefinitionssetoutinAnnexIshallalsoapply.2001R0999—EN—01.01.2002—003.001—6
(1) Council Directive 89/662/EEC of11December 1989concerning veterinary
checks in intra-Community trade with a view to the completion of the
internal market (OJ L 395, 30.12.1989, p. 13). Directive as last amended
byCouncilDirective92/118/EEC(OJL62,15.3.1993,p.49).
(2) Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and
zootechnical checks applicable in intra-Community trade in certain live
animals and products with a view to the completion of the internal market
(OJL 224, 18.8.1990,p. 29). Directive as last amended by Council Direc-
tive92/118/EEC.
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3. WherethetermsinthisRegulationarenotdefinedinparagraph1
orAnnexI,therelevantdefinitionsgiveninRegulation(EC)No1760/2000(
1) and those given in or pursuant to Directives 64/432/EEC(2),
89/662/EEC, 90/425/EEC and 91/68/EEC(3) shall apply insofar as
referenceismadetotheminthistext.
Article 4
Safeguardmeasures
1. With regard to the implementation of safeguard measures, the
principlesandprovisionssetoutinArticle9ofDirective89/662/EEC,Article 10 of Directive 90/425/EEC, Article 18 of Directive 91/496/
EEC(
4)andArticle22ofDirective97/78/EC(5)shallapply.
2. The safeguard measures shall be adopted in accordance with the
procedurereferredtoinArticle24(2)andshallbenotifiedatthesametimetotheEuropeanParliament,statingthereasons.
CHAPTERII
DETERMINATIONOFBSESTATUS
Article 5
Classification
1. TheBSEstatusofaMemberState,ofathirdcountry,orofone
of their regions (hereinafter referred to as ‘countries or regions’) may
be determined only on the basis of the criteria set out in Annex II,
Chapter A, and the outcome of a risk analysis on the basis of all thepotential factors for the appearance of bovine spongiformencephalo-pathy as defined in Annex II, Chapter B, and their development overtime.
MemberStates,andthirdcountrieswishingtoberetainedonthelistof
third countries approved for the export to the Community of the live
animals oroftheproductscovered bythisRegulation, shall submittothe Commission an application for their BSE status to be determined,accompanied by the relevant information on the criteria set out inAnnex II, Chapter A, and on the potential risk factors specified in
AnnexII,ChapterB,andtheirdevelopmentovertime.
2. Adecisiononeachapplication,placingtheMemberStateorthird
country or region of the Member State or third country whichsubmittedtheapplicationinoneofthecategoriesdefinedinAnnexII,ChapterC,shallbeadopted,takingaccountofthecriteriaandpotentialrisk factors set out in paragraph 1, in accordance with the procedure
referredtoinArticle24(2).2001R0999—EN—01.01.2002—003.001—7
(1) Regulation (EC) No 1760/2000 of the European Parliament and of the
Council of 17 July 2000 establishing a systemfor the identification and
registration of bovine animals and regarding the labelling of beef and beef
products and repealing Council Regulation (EC) No 820/97 (OJ L 204,
11.8.2000,p.1).
(2) Council Directive 64/432/EEC of 26 June 1964 on animal health problems
affecting intra-Community trade in bovine animals and swine (OJ 121
29.7.1964,p.1977/64).Directive aslastamended byDirective 2000/20/EC
oftheEuropeanParliamentandoftheCouncil(OJL163,4.7.2000,p.35).
(3) Council Directive 91/68/EEC of 28 January 1991 on animal health condi-
tionsgoverningintra-Community trade inovine andcaprine animals (OJL
46, 19.2.1991, p. 19). Directive as last amended by Commission Decision
94/953/EC(OJL371,31.12.1994,p.14).
(4) Council Directive 91/496/EEC of 15 July 1991 laying down the principles
governing the organisation of veterinary checks on animals entering the
Community from thirdcountries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (OJ L 268, 24.9.1991, p. 56). Directive as last
amendedbyDirective96/43/EC(OJL162,1.7.1996,p.1).
(
5) Council Directive 97/78/EC of 18 December 1997 laying down the princi-
ples governing the organisation of veterinary checks on products entering
theCommunityfromthirdcountries(OJL24,30.1.1998,p.9).
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Thisdecisionshallbetakenwithinsixmonthsofthesubmissionofthe
application and of the relevant information referred to in the secondsubparagraph of paragraph 1. If the Commission finds that the
supporting evidence does not include the information laid down in
AnnexII,Chapters AandB,it shall askforadditional information tobe provided within a period to be specified. The final decision shallthenbetakenwithinsixmonthsofthesubmissionofallinformation.
After the International Office of Epizootic Diseases (OIE) has estab-
lished a procedure for the classification of countries by category andif it has placed the applicant country in one of those categories, a re-assessment of the Community categorisation of the country concernedin accordance with the first subparagraph of this paragraph may bedecided, if appropriate, in accordance with the procedure referred to
inArticle24(2).
3. If the Commission finds that the information submitted by a
Member State or a third country pursuant to Annex II, Chapters AandB,isinsufficientorunclear,itmay,inaccordancewiththeproce-dure referred to in Article 24(2), determine the BSE status of the
Member State or third country concerned on the basis of a full risk
analysis.
Suchariskanalysismustincludeaconclusivestatisticalsurveyofthe
epidemiological situation regarding TSEs in the applicant Member
Stateorthirdcountry,onthebasisoftheuse,inascreeningprocedure,
of rapid tests. The Commission shall take into account the classifica-tioncriteriausedbytheOIE.
The rapid tests shall be approved for that purpose in accordance with
theprocedure referred toinArticle 24(2)andentered onalist setout
inAnnexX,ChapterC,point4.
SuchscreeningproceduremayalsobeusedbyMemberStatesorthird
countrieswhichwishtohavetheclassificationtheycarriedoutonthatbasis approved by the Commission — in accordance with the proce-durelaiddowninArticle24(2).
The cost of such screening procedure shall be borne by the Member
Stateorthirdcountryconcerned.
4. Member States or third countries which have not submitted an
application in accordance with paragraph 1 within six months of 1
July 2001 shall, with respect to the dispatch fromtheir territory of
live animals andproductsofanimal origin,beconsidered ascountriesin category 5, referred to in Annex II, Chapter C, until they havesubmittedsuchanapplication.
5. MemberStatesshallnotifytheCommissionassoonaspossibleof
anyepidemiologicalevidenceorotherinformationwhichmightleadto
a change in BSE status, in particular the results of the monitoringprogrammesprovidedforinArticle6.
6. The retention of a third country on one of the lists provided for
byCommunityrulesforthepurposeofbeingallowedtoexporttothe
Community live animals and products of animal origin for which this
Regulation provides specific rules shall be decided upon under theprocedurelaiddowninArticle24(2)andshallbemadeconditional—inthelightoftheinformationavailableorwhereaTSEispresumedtobe present — on the information provided for in paragraph 1 being
supplied. In the event of refusal to supply the said information within
threemonthsofthedateoftheCommission'srequest,theprovisionsofparagraph 4 of this Article shall apply until this information has beensubmittedandevaluatedinaccordancewithparagraphs2or3.
The eligibility of third countries to export to the Community live
animals, or products of animal origin for which this Regulation
provides specific rules, under conditions based on their category asestablished bythe Commission, shall be conditional upontheir under-taking to notify the latter in writing as soon as possible of anyepidemiological or other evidence which might lead to a change inBSEstatus.2001R0999—EN—01.01.2002—003.001—8
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7. A decision may be taken, under the procedure laid down in
Article 24(2), to change the BSE classification of a Member State orthird country, or of one of its regions, in accordance with the results
ofthechecksprovidedforinArticle21.
8. The decisions referred to in paragraphs 2, 3, 4, 6 and 7 shall be
basedonariskassessment,takingintoconsiderationtherecommendedcriteriasetoutinAnnexII,ChaptersAandB.
CHAPTERIII
PREVENTIONOFTSE
Article 6
Monitoringsystem
1. Each Member State shall carry out an annual programme for
monitoringBSEandscrapieinaccordancewithAnnexIII,ChapterA.Thatprogrammeshallincludeascreeningprocedureusingrapidtests.
Rapid tests shall be approved for that purpose in accordance with the
procedure referred to in Article 24(2) and listed in Annex X, ChapterC,point4.
2. Each Member State shall inform the Commission and the other
Member States, within the Standing Veterinary Committee, of theemergenceofaTSEotherthanBSE.
3. All official investigations and laboratory examinations shall be
recordedinaccordancewithAnnexIII,ChapterB.
4. Member States shall submit an annual report to the Commission
covering at least the information referred to in Annex III, Chapter B,
PartI.Thereportforeachcalendaryearshallbesubmittedatthelatest
by 31 March of the following year. The Commission shall present asummary of the national reports covering at least the informationreferredtoinAnnexIII,ChapterB,PartII,totheStandingVeterinaryCommitteewithinthreemonthsofthereceiptofthesaidreports.
Article 7
Prohibitionsconcerninganimalfeeding
1. The feeding to ruminants of protein derived from mammals is
prohibited.
2. Furthermore, the prohibition referred to in paragraph 1 shall be
extended toanimals andproducts ofanimal origin inaccordance withpoint1ofAnnexIV.
3. Paragraphs1and2shallapplywithoutprejudicetotheprovisions
setoutinpoint2ofAnnexIV.
4. Member States, or regions thereof, in category 5 shall not be
permitted to export or store feed intended for farmed animals which
containsproteinderivedfrommammalsorfeedintendedformammals,
except for dogs and cats, which contains processed protein derivedfrommammals.
Thirdcountries,orregionsthereof,incategory5shallnotbepermitted
toexporttotheCommunityfeedintendedforlivestockwhichcontainsprotein derived from mammals or feed intended for mammals, except
for dogs and cats, which contains processed protein derived from
mammals.
5. DetailedrulesfortheimplementationofthisArticle,inparticular
rules on the prevention of cross-contamination and on the methods ofsampling and analysis required to check compliance with this Article,shallbeadoptedinaccordancewiththeprocedurereferredtoinArticle24(2).2001R0999—EN—01.01.2002—003.001—9
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Article 8
Specifiedriskmaterial
1. The specified risk material shall be removed and destroyed in
accordancewithpoints2,3,4and8ofAnnexV.
Thatspecifiedriskmaterialorthematerialprocessedtherefrommaybe
placedonthemarketor,ifneedbe,exportedonlyforfinaldestruction
inaccordancewithpoints3and4orasappropriate7(c)or8ofAnnex
V. It may not be imported into the Community. Transit of specifiedrisk material through Community territory must take place in accor-dancewiththerequirementsofArticle3ofDirective91/496/EEC.
2. Paragraph 1 shall not apply to tissues fromanim als which have
undergone an alternative test approved for that distinct purpose inaccordance with the procedure referred to in Article 24(2) and listedinAnnexX,ChapterC,point5,andappliedundertheconditionslisted
inpoint5ofAnnexV—andwheretheresultsofthetestwerenega-
tive.
The Member States which authorise that alternative test must inform
theotherMemberStatesandtheCommission.
3. In Member States, or regions thereof, which are placed in cate-
gories2,3,4and5referredtoinAnnexII,ChapterC,thelaceration,
afterstunning,ofcentralnervoustissuebymeansofanelongatedrod-
shaped instrument introduced into the cranial cavity shall not be usedonbovine,ovineorcaprineanimalswhosemeatisdestinedforhumanoranimalconsumption.
4. The data relating to age set out in Annex V shall be adjusted
regularly. Such adjustments shall be based on the latest proven scien-tificfindingsconcerningthestatisticalprobabilityoftheoccurrenceofaTSEintherelevantagegroupsoftheCommunity'sbovine,ovineandcaprinepopulation.
5. Bywayofderogationfromparagraphs1to4,adecisionmaybe
adopted,inaccordancewiththeprocedurereferredtoinArticle24(2),with regard to the date of effective enforcement of Article 7(1) or, as
appropriate, in the third countries, the date of banning the use of
mammalian protein in feed for ruminants in each country or regionplaced in category 3 or 4, in order to limit the application of thisArticletoanimalsbornbeforethatdateinthosecountriesorregions.
Similarly,bywayofderogationfromparagraphs1to4,afterconsulta-
tion of the appropriate scientific committee and on the basis of anassessment of the incident, propagation and human exposure risk, adecision may be adopted inaccordance withthe procedure referred to
in Article 24(2) to allow the use for food, feed and fertilisers of
vertebral column and dorsal root ganglia from bovine animals in orcomingfromeachcountryorregionthereofplacedincategory5.
6. Rules for the implementation of this Article shall be adopted in
accordancewiththeprocedurereferredtoinArticle24(2).
Article 9
Products of animal origin derived from or containing ruminant
material
1. The products of animal origin listed in Annex VI shall not be
produced from ruminant material from countries or regions thereofwhichareplacedincategory5unlesstheyareproducedinaccordancewith the production processes approved in accordance with the proce-durereferredtoinArticle24(2).
2. Bones of the head, and vertebral columns of bovine, ovine and
caprine animals from countries, or regions thereof, which are placedin categories 2, 3, 4 or 5, shall not be used for the production of
mechanicallyrecoveredmeat.
3. Paragraphs1and2shallnotapply,inthelightofthecriteriaset
out in point 5 of Annex V, to ruminants which have undergone an2001R0999—EN—01.01.2002—003.001—10
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alternative test which has been recognised in accordance with the
procedure referred to in Article 24(2), where the results of the testwerenegative.
4. Rules for the implementation of this Article shall be adopted in
accordancewiththeprocedurereferredtoinArticle24(2).
Article 10
Educationprogrammes
1. MemberStatesshallensurethatstaffofthecompetent authority,
of diagnostic laboratories and colleges of agriculture and veterinarymedicine,officialveterinarians,veterinarypractitioners,slaughterhouse
personnel and animal breeders, keepers and handlers have been given
training in the clinical signs, epidemiology and, in the case of staffresponsible forcarrying out checks, in interpreting laboratory findingsrelatingtoTSEs.
2. Toensureeffectiveimplementationoftheeducationprogrammes
provided for in paragraph 1, financial assistance from the Community
maybegranted.Theamountofsuchassistanceshallbedeterminedin
accordancewiththeprocedurereferredtoinArticle24(2).
CHAPTERIV
CONTROLANDERADICATIONOFTSEs
Article 11
Notification
WithoutprejudicetoDirective82/894/EEC(1),theMemberStatesshall
ensurethatanyanimalsuspectedofbeinginfectedbyaTSEisnotifiedimmediatelytothecompetentauthorities.
Member States shall regularly inform each other and the Commission
ofthecasesofTSEnotified.
The competent authority shall without delay take the measures laid
down in Article 12 of this Regulation, together with any other neces-
sarymeasures.
Article 12
Measureswithrespect tosuspectanimals
1. AnyanimalsuspectedofbeinginfectedbyaTSEshallbeplaced
underanofficialmovementrestrictionuntiltheresultsofaclinicalandepidemiologicalexaminationcarriedoutbythecompetentauthorityare
known,orkilledforlaboratoryexaminationunderofficialcontrol.
IfBSEissuspectedinabovineanimalataholdinginaMemberState,
all other bovine animals from that holding shall be placed under anofficial movement restriction until the results of the examination areavailable.
If BSE is suspected in an ovine or caprine animal at a holding in a
MemberStateonthebasisofobjectiveevidencesuchastheresultsof
tests capable of differentiating in a practical way between the variousTSEs, all other ovine and caprine animals from that holding shall beplaced under an official movement restriction until the results of theexaminationareavailable.
If there is evidence that the holding where the animal was present
when BSE was suspected is not likely to be the holding where the
animalcouldhavebeenexposedtoBSE,thecompetent authoritymaydecidethatonlytheanimalsuspectedofbeinginfectedshallbeplaced2001R0999—EN—01.01.2002—003.001—11
(1) Council Directive 82/894/EEC of 21December 1982onthe notification of
animaldiseaseswithintheCommunity(OJL378,31.12.1982,p.58).Direc-
tive as last amended by Commission Decision 2000/556/EC (OJ L 235,
19.9.2000,p.27).
▼B
under an official movement restriction. If considered necessary, the
competent authority may also decide that other holdings or only theholding of exposure shall be placed under official control depending
ontheepidemiologicalinformationavailable.
UndertheprocedurereferredtoinArticle24(2)andbywayofderoga-
tion fromthe requirem ents of the second, third and fourth
subparagraphs of this paragraph, a Member State may be exempted
fromtheapplicationofofficialrestrictionsonthemovementofanimalsifitappliesmeasuresofferingequivalentsafeguards.
2. Where the competent authority decides that the possibility of
infectionwithaTSEcannotberuledout,theanimalshallbekilled,if
itisstillalive;itsbrainandallothertissuesasthecompetentauthoritymay determine shall be removed and sent to an officially approvedlaboratory, the national reference laboratory provided for in Article19(1) or the Community reference laboratory provided for in Article19(2), for examination in accordance with the testing methods laid
downinArticle20.
3. All parts of the body of the suspect animal including the hide
shall be retained under official control until a negative diagnosis hasbeenmadeorshallbedestroyedinaccordance withAnnexV,point3
or4.
4. Rules for the implementation of this Article shall be adopted in
accordancewiththeprocedurereferredtoinArticle24(2).
Article 13
Measuresfollowingconfirmationofthepresence ofaTSE
1. When the presence of a TSE has been officially confirmed, the
followingmeasuresshallbeappliedassoonaspossible:
(a) allpartsofthebodyoftheanimalshallbecompletelydestroyedin
accordance withAnnexVapartfrommaterial retained forrecords
inaccordancewithAnnexIII,ChapterB,III,2;
(b) an inquiry shall be carried out to identify all animals at risk in
accordancewithAnnexVII,point1;
(c) allanimalsandproductsofanimaloriginreferredtoinAnnexVII,
point 2, that have been identified as being at risk by the inquiry
referredtoin(b),shallbekilledandcompletelydestroyedinaccor-dancewithAnnexV,points3and4.
By way of derogation from this paragraph, Member States may apply
other measures offering an equivalent level of protection, if those
measures have been approved in accordance with the procedurereferredtoinArticle24(2).
2. Pending the implementation of the measures referred to in para-
graph1(b)and(c),theholdingonwhichtheanimalwaspresentwhen
the presence of a TSE was confirmed shall be placed under officialcontrolandallmovementofanimalssusceptibletoTSEsandproductsof animal origin derived from them from or to the holding shall besubject to authorisation by the competent authority, with a view to
ensuring immediate tracing and identification of the animals and
productsofanimaloriginconcerned.
If there is evidence that the holding where the affected animal was
present when the TSE was confirmed is not likely to be the holding
where the animal was exposed to the TSE, the competent authority
may decide that both holdings or only the holding of exposure shallbeplacedunderofficialcontrol.
3. Member States which have implemented a substitute scheme
offering equivalent safeguards provided for in the fifth subparagraph
of Article 12(1) may, by way of derogation from the requirements ofparagraph1(b)and(c),beexemptedinaccordance withtheprocedurereferred to in Article 24(2) fromthe requirem ent to apply officialrestrictions on the movement of animals and from the requirement tokillanddestroyanimals.2001R0999—EN—01.01.2002—003.001—12
▼B
4. Owners shall be compensated without delay for the loss of the
animals that have been killed or products of animal origin destroyedin accordance with Article 12(2) and paragraph 1(a) and (c) of this
Article.
5. Without prejudice to Directive 82/894/EEC, the confirmed
presenceofanyTSEotherthanBSEshallbenotifiedtotheCommis-
siononanannualbasis.
6. Rules for the implementation of this Article shall be adopted in
accordancewiththeprocedurereferredtoinArticle24(2).
Article 14
Contingencyplan
1. Member States shall draw up — in accordance with the general
criteriaofCommunityrulesonthecontrolofanimaldiseases—guide-
lines specifying the national measures to be implemented and
indicating competences and responsibilities where cases of TSE areconfirmed.
2. Where necessary to enable Community legislation to be applied
uniformly, the guidelines may be harmonised in accordance with theprocedurereferredtoinArticle24(2).
CHAPTERV
PLACINGONTHEMARKETANDEXPORT
Article 15
Liveanimals,theirsemen,embryosandova
1. Placing on the market or, if need be, export of bovine, ovine or
caprine animals and their semen, embryos and ova shall be subject to
the conditions laid down inAnnexVIII,or,inthe case of imports, tothe conditions laid down in Annex IX. The live animals and theirembryos and ova shall be accompanied by the appropriate animalhealthcertificatesasrequiredbyCommunitylegislation,inaccordance
withArticle17or,inthecaseofimports,Article18.
2. The placing on the market of first generation progeny, semen,
embryosandovaofTSEsuspectorconfirmedanimalsshallbesubject
totheconditionslaiddowninAnnexVIII,ChapterB.
3. Rules for the implementation of this Article shall be adopted in
accordancewiththeprocedurereferredtoinArticle24(2).
Article 16
Placingonthemarketofproductsofanimalorigin
1. The following products of animal origin derived from healthy
ruminants shallnotbesubjecttorestrictions onplacingonthemarketor,ifneedbe,exportpursuanttothisArticle,toAnnexVIII,Chapters
CandD,andtoAnnexIX,ChaptersA,C,FandG:
(a) products of animal origin covered by Article 15, in particular
semen,embryosandova;
(b) (i) rawmilkwithinthemeaningofDirective92/46/EEC(
1);
(ii) milk for the manufacture of milk-based products within the
meaningofDirective92/46/EEC;
(iii) heat-treateddrinkingmilkwithinthemeaningofDirective92/
46/EEC;
(iv) di-calciumphosphate(withoutanytraceofproteinorfat);2001R0999—EN—01.01.2002—003.001—13
(1) CouncilDirective92/46/EECof16June1992layingdownthehealthrules
fortheproductionandplacingonthemarketofrawmilk,heat-treatedmilk
and milk-based products (OJ L 268, 14.9.1992, p. 1). Directive as last
amendedbyDirective96/23/EC(OJL23.5.1996,p.10).
▼B
(v) hides and skins within the meaning of Directive 92/118/
EEC(1);
(vi) gelatinewithinthemeaningofDirective92/118/EEC,derived
fromthehidesandskinsreferredtoinpoint(v);
(vii) collagenderivedfromthehidesandskinsreferredtoinpoint
(v).
2. Productsofanimaloriginimportedfromathirdcountryplacedin
categories 2, 3, 4 and 5 must come from healthy bovine, ovine andcaprine animals which have not been subjected to a laceration of the
centralnervoustissueasreferredtoinArticle8(3)orkilledbymeans
ofagasinjectedintothecranialcavity.
3. Products of animal origin containing materials obtained from
bovine animals originating in a Member State, a region of a MemberStateorathirdcountryclassifiedincategory5shallnotbeplacedon
themarketunlesstheycomefrom:
(a) animals born after the date from which the prohibition on the
feeding to ruminants of animal protein derived from mammalswaseffectivelyenforced;or
(b) animals which were born, raised and have stayed in herds with a
certifiedhistoryoffreedomfromBSEforatleastsevenyears.
Furthermore,productsofanimaloriginshallnotbedespatchedfroma
MemberStateoraregionofaMemberStateclassifiedincategory5to
anotherMemberStateorbeimportedfromathirdcountryclassifiedin
category 5. That prohibition shall not apply to products of animaloriginlistedinAnnexVIII,Chapter C,andfulfilling therequirementsof Annex VIII, Chapter C. They must be accompanied by an animalhealth certificate issued byan official veterinarian certifying that they
havebeenproducedinconformitywiththisRegulation.
4. Whenananimalismovedfromacountryoraregiontocountry
or region included in another category, it shall be classified in thehighest category of the countries or regions in which it has stayedover twenty-four hours unless adequate guarantees can be provided
certifying that the animal has not received feedingstuffs from the
countryorregionclassifiedinthehighestcategory.
5. Products of animal origin for which this Article lays down
specific rules shall be accompanied by the appropriate animal healthcertificatesorcommercialdocumentsasrequiredbyCommunitylegis-
lation inaccordance withArticles 17and18or,ifsuchcertificates or
documents are notprovided forinCommunity legislation, bya healthcertificate or commercial document the specimens of which shall beestablished in accordance with the procedure referred to in Article24(2).
6. For the purpose of import into the Community, products of
animal origin shall comply with the conditions laid down in AnnexIX,ChaptersA,C,FandG.
7. InaccordancewiththeprocedurereferredtoinArticle24(2),the
provisions of paragraphs 1 to 6 may be extended to other products of
animal origin. Rules for the implementation of this Article shall be
adoptedbythesameprocedure.
Article 17
UndertheprocedurereferredtoinArticle24(2),thehealthcertificates
referred to in Annex F to Directive 64/432/EEC, Models II and III inAnnexEtoDirective91/68/EECandtheappropriatehealthcertificates2001R0999—EN—01.01.2002—003.001—14
(1) Council Directive 92/118/EEC of 17 December 1992 laying down animal
health and public health requirements governing trade in and imports intothe Community of products not subject to the said requirements laid down
inspecificCommunityrulesreferredtoinAnnexA(1)toDirective89/662/
EEC and, as regards pathogens, in Directive 90/425/EEC (OJ L 62,
15.3.1993, p. 49). Directive as last amended by Commission Decision
1999/724/EC(OJL290,12.11.1999,p.32).
▼B
laid down by Community legislation relating to trade in the semen,
embryos andova ofbovine, ovine orcaprine animals shall be supple-mented,wherenecessary,byareferencetothecategoryspecifyingthe
classification of the Member State or region of origin given in accor-
dancewithArticle5.
Appropriate commercial documents relating to trade in products of
animal origin shall be supplemented, where necessary, by a referenceto the category of the Member State or region of origin given by theCommissioninaccordancewithArticle5.
Article 18
The appropriate health certificates relating to imports provided for by
Communitylegislationshall,undertheprocedurereferredtoinArticle
24(2),besupplementedinrespectofthirdcountriesclassifiedinacate-gory pursuant to Article 5 by the specific requirements laid down inAnnexIX,assoonasthatclassificationdecisionhasbeentaken.
CHAPTERVI
REFERENCE LABORATORIES, SAMPLING, TESTING AND
CONTROLS
Article 19
Reference laboratories
1. The national reference laboratories in each Member State and
theirfunctionsanddutiesshallbethoseindicatedinAnnexX,ChapterA.
2. TheCommunityreferencelaboratoryanditsfunctionsandduties
shallbethoselaiddowninAnnexX,ChapterB.
Article 20
Samplingandlaboratorymethods
1. Sampling and laboratory testing for the presence of a TSE shall
be carried out using the methods and protocols laid down in AnnexX,ChapterC.
2. WherenecessarytoensuretheuniformapplicationofthisArticle,
implementingrules,includingthemethodtoconfirmBSEinovineandcaprine animals, shall be adopted in accordance with the procedure
referredtoinArticle24(2).
Article 21
Communitycontrols
1. Experts from the Commission may make on-the-spot checks in
cooperation with the competent authorities of the Member States,insofar as is necessary for the uniformapplication of this Regulation.The Member State in whose territory checks are made shall providethe experts with all the assistance necessary for carrying out theirduties. The Commission shall inform the competent authority of the
resultsofthechecksmade.
The rules for the application of this Article, and in particular those
governing the procedure for cooperation with the national authorities,shallbeadoptedinaccordancewiththeprocedurereferredtoinArticle24(2).
2. Community checks concerning third countries shall be made in
accordancewithArticles20and21ofDirective97/78/EC.2001R0999—EN—01.01.2002—003.001—15
▼B
CHAPTERVII
TRANSITIONALANDFINALPROVISIONS
Article 22
Transitionalmeasuresconcerningspecifiedriskmaterial
1. TheprovisionsofAnnexXI,PartAshallapplyforaperiodofat
leastsixmonthsfrom1July2001andshallceasetoapplyimmediately
followingthedateofadoptionofadecisioninaccordancewithArticle5(2)or(4),onwhichdateArticle8shallenterintoforce.
2. Theresultsofaconclusivestatisticalsurveycarriedoutinaccor-
dance with Article 5(3) during the transitional period shall be used toconfirmoroverturntheriskanalysisconclusionsreferredtoinArticle5(1), while taking account of the classification criteria defined by theOIE.
3. After consultation of the appropriate scientific committee,
detailed rules concerning that statistical survey shall be adopted in
accordancewiththeprocedurereferredtoinArticle24(2).
4. Theminimumcriteriatobemetbythisstatisticalsurveyshallbe
thoselaiddowninPartBofAnnexXI.
Article 23
Amendmentoftheannexesandtransitionalmeasures
Afterconsultationoftheappropriatescientificcommitteeonanyques-
tionwhichcouldhaveanimpactonpublichealth,theannexesshallbeamended or supplemented and any appropriate transitional measuresshallbeadoptedinaccordancewiththeprocedurereferredtoinArticle24(2).
In accordance with that procedure, transitional measures shall be
adoptedforamaximumperiodoftwoyearstopermitthechange-over
from the current arrangements to the arrangements established by this
Regulation.
Article 24
Committees
1. The Commission shall be assisted by the Standing Veterinary
Committee. However, for matters exclusively concerning animalfeedingstuffs, the Commission shall be assisted by the StandingCommittee on Feedingstuffs and, for matters exclusively concerning
foodstuffs,bytheStandingCommitteeonFoodstuffs.
2. Where reference is made to this paragraph, Articles 5 and 7 of
Decision 1999/468/EC shall apply, in compliance with Article 8
thereof.
The period referred to in Article 5(6) of that Decision shall be three
months and, in the case of safeguard measures referred to in Article
4(2)ofthisRegulation,15days.
3. EachCommitteeshalladoptitsrulesofprocedure.
Article 25
Consultationofthescientific committees
Theappropriatescientificcommitteesshallbeconsultedonanymatter
within the scope of this Regulation which could have an impact onpublichealth.
Article 26
Entryintoforce
ThisRegulationshallenterintoforceonthedayfollowingitspublica-
tioninthe Official Journal of the European Communities .2001R0999—EN—01.01.2002—003.001—16
▼B
Itshallapplyfrom1July2001.
ThisRegulation shallbebindinginitsentirety anddirectly applicable
inallMemberStates.2001R0999—EN—01.01.2002—003.001—17
▼B
ANNEX I
SPECIFICDEFINITIONS
ForthepurposeofthisRegulation:
(a) ‘indigenous case of BSE’ means a case of bovine spongiform encephalitis
which has not been clearly demonstrated to be due to infection prior to
importationasaliveanimal,embryoorovum;
(b) ‘discrete adipose tissue’ means internal and external body fat removed
during the slaughter and cutting process, in particular fresh fat fromthe
heart, caul, kidneys and mesentery of bovine animals, and fat from cutting
rooms;
(c) ‘cohort’ means a group of bovine animals which were either born in the
same herd as, and within 12 months preceding or following the birth of,
the affected cattle or reared together with the affected animal at any time
during the first year of their life and which may have consumed the same
feedasthatwhichtheaffectedanimalconsumedduringthefirstyearofits
life;
(d) ‘landfill site’ means a wastedisposal site as defined by Directive 1999/31/
EC(1).2001R0999—EN—01.01.2002—003.001—18
(1) Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (OJ L 182,
16.7.1999,p.1).
▼B
ANNEX II
DETERMINATIONOFBSESTATUS
CHAPTERA
TheBSEstatusofaMemberStateorathirdcountryorofoneoftheirregions,
hereinafterreferredtoas‘countryorregion’,shallbedeterminedonthebasisof
thefollowingcriteria:
(a) the outcome of a risk analysis identifying all the potential factors for the
appearance of BSE referred to in Chapter B and their development over
time;
(b) aneducationprogrammeforveterinarians,breedersandthosewhotransport,
trade in and slaughter bovine animals, which seeks to encourage them to
reportallcasesofneurologicalmanifestationsinadultbovineanimals;
(c) the compulsory reporting and examination of all bovine animals showing
clinicalsignsofBSE;
(d) asystemofcontinuoussurveillance andmonitoring ofBSEwithparticular
reference to the risksdescribed in Chapter B, taking account of the guide-
lines in the table of Chapter A of Annex III or in accordance with the
appropriate international standards; reports on the number of examinations
carriedoutandtheresultsthereofmustbekeptforatleastsevenyears;
(e) theexaminationinanapprovedlaboratoryofsamplesofencephalaorother
tissuescollectedunderthesurveillancesystemmentionedinpoint(d).
CHAPTERB
The risk analysis referred to in Chapter A(a) shall be based on the following
factors:
— the consumption by bovine animals of meat and bone meal or greaves
derivedfromruminants;
— theimportation ofmeat and bonemeal orgreaves potentially contaminated
byaTSEoranimalfeedcontainingmeatandbonemealorgreaves;
— theimportationofanimalsorova/embryospotentiallyinfectedbyaTSE;— theepidemiologicalstatusofthecountryorregioninregardtoanimalTSEs;
— theextentofknowledgeaboutthestructureofthebovine,ovineandcaprine
populationinthecountryorregion;
— thesourceofanimalwaste,theparametersoftheprocessesfortreatingsuch
wasteandthemethodsofproducinganimalfeed.
CHAPTERC
Definitionofcategories
The BSE status of Member States or third countries or one of the regions
thereofshallbedeterminedbyclassificationintothefollowingcategories:
A. CATEGORY1: CountryorregionfreeofBSE
A country or region where a risk analysis based on the information laid
downinChapterBhasbeenconductedwhichdemonstratedthatappropriate
measureshavebeentakenfortherelevantperiodoftime,tomanageanyrisk
identifiedand
1. EITHERnoBSEcasehasbeenrecordedand:
(i) the criteria in Chapter A(b) to (e) have been complied with for at
leastsevenyears,or
(ii) the criteria in Chapter A(c) have been complied with for at least
sevenyearsandithasbeendemonstratedthatforatleasteightyears
no meat and bone meal or greaves derived from ruminants or
mammalshasbeenfedtoruminants;
2. OR where all cases of BSE have been clearly demonstrated to originate
directly from the importation oflive bovineanimals or bovineembryos/
ova,andalltheaffected bovineanimals aswellas,ifthesearefemales,
theirlastprogenybornwithintwoyearspriorto,orafter,thefirstclinical
signsofonsetofthedisease,ifaliveinthecountryorregion,havebeen
killedandcompletelydestroyedand,either
(i) the criteria in Chapter A(b) to (e) have been complied with for at
leastsevenyears,or2001R0999—EN—01.01.2002—003.001—19
▼B
(ii) the criteria in Chapter A(c) have been complied with for at least
sevenyearsandithasbeendemonstratedthatforatleasteightyears
nomeatandbonemealorgreaveshavebeenfedtoruminants;
3. ORwherethelastindigenouscaseofBSEwasreportedmorethanseven
yearsago,thecriteriainChapterA(b)to(e)havebeencompliedwithfor
at least seven years and the feeding of ruminants with meat and bone
meal and greaves derived from ruminants has been banned and the ban
hasbeeneffectivelyenforcedforatleasteightyears.
B. CATEGORY 2: BSE provisionally free country or region where no indi-
genouscasehasbeenreported
CountryorregionwhereariskanalysisasdescribedinChapterBhasbeen
conductedwhichdemonstratesthatappropriatemeasureshavebeentakenfor
therelevantperiodoftimetomanageanyriskidentified,and
1. EITHERwheretherehasbeennocaseofBSEand:
(i) the criteria in Chapter A(b) to (e) are complied with, but have not
beencompliedwithforsevenyears,or
(ii) it has been demonstrated that for at least eight years no meat and
bone meal or greaves has been fed to ruminants, but the criteria in
ChapterA(c)havenotbeencompliedwithforsevenyears;
2. OR where all cases of BSE have been clearly demonstrated to originate
directly from the importation oflive bovineanimals or bovineembryos/
ova,andalltheaffected bovineanimals aswellas,ifthesearefemales,
theirlastprogenybornwithintwoyearspriorto,orafter,thefirstclinical
signsofonsetofthedisease,ifaliveinthecountryorregion,havebeen
killedandcompletelydestroyed,andeither:
(i) the criteria in Chapter A(b) to (e) are complied with, but have not
beencompliedwithforsevenyears,or
(ii) it has been demonstrated that for at least eight years no meat and
bone meal or greaves has been fed to ruminants, but the criteria in
ChapterA(c)havenotbeencompliedwithforsevenyears.
C. CATEGORY3: BSEprovisionallyfreecountryorregionwhereatleastone
indigenouscasehasbeenreported
Any country or region where a risk analysis based on the information
referredtoinChapterBhasbeenconductedwhichdemonstratesthatappro-
priate measures have been taken for the relevant period of time to manage
anyriskidentifiedand:
1. EITHER the last indigenous case of BSE was reported more than seven
years ago, the criteria in Chapter A(b) to (e) are complied with and the
banonfeeding ruminants withmeat and bonemeal andgreaves derived
fromruminantsiseffectivelyenforced,but:
(i) the criteria in Chapter A(b) to (e) have not been complied with for
sevenyears,or
(ii) the ban on feeding ruminants withmeat and bone meal and greaves
derived fromrum inants has not been effectively enforced for eight
years;
2. OR where the last indigenous case has been reported less than seven
years ago, the BSEincidence rate, calculated onthe basisof indigenous
cases,hasbeenlessthanonecasepermillionduringeachofthelastfour
consecutive twelve-month periods within the bovine animal population
over24monthsofageinthecountryorregionor—wheninacountry
or a region the bovine animal population over 24 months of age is less
than 1 million animals — one case per real number of this population
(calculatedonthebasisofEurostatstatistics),andwhere:
(i) thebanonfeedingruminantswithmeatandbonemealandgreaves
derived fromrum inants has been effectively enforced for at least
eightyears;
(ii) the criteria in Chapter A(b) to (e) have been complied with for at
leastsevenyears;
(iii) theaffectedbovineanimalsaswellas:
— if these are females, their last progeny born within two years
priorto,orafter,clinicalonsetofthedisease;
— allbovineanimalsfromthecohort,
are killed and completely destroyed if they are still alive in the
countryorregionconcerned.
For this classification account may be taken, by way of derogation
frompoint (iii), of the existence of other m easures offering an
equivalentlevelofprotectioninrelationtothekillingofanimalsat
risk.2001R0999—EN—01.01.2002—003.001—20
▼B
D. CATEGORY4: CountryorregionwithlowincidenceofBSE
Anycountryorregionwhere:
1. thecriterialistedinChapterAarecompliedwith,andtheBSEincidence
rate,calculatedoverthepast12months,hasbeengreaterthanorequalto
one indigenous case per million and less than or equal to one hundredcasespermillionwithinthebovineanimalpopulationover24monthsof
ageinthecountryorregion;or
2. thecriterialistedinChapterAarecompliedwithandtheBSEincidence
rate,calculatedasspecifiedinpoint1hasbeenlessthanoneindigenous
casepermillionforlessthanfourconsecutive12monthperiodsandthe
affectedcattleaswellas:
— ifthesearefemales,theirlastprogenybornwithintwoyearspriorto,
orafterthefirstclinicalsignsofonsetofthedisease,
— allbovineanimalsfromthecohort,
ifaliveinthecountryorregion,arekilledandcompletelydestroyed.
Forthisclassification account maybetaken, bywayofderogation from
thispoint,oftheexistenceofothermeasuresofferinganequivalentlevel
ofprotectioninrelationtothekillingofanimalsatrisk.
Countries or regions where the BSE incidence rate, calculated over the
past12months,hasbeenlessthanoneindigenouscasepermillionwithin
thecattlepopulationover24monthsofageinthecountryorregion,but
where a risk analysis as described in Chapter A has been conducted
which demonstrates that at least one of the criteria enabling the country
orregiontobeclassifiedincategory2or3isnotcompliedwith,mustbe
regardedascountriesorregionsbelongingtocategory4.
E. CATEGORY5: CountryorregionwithhighincidenceofBSE
Anycountryorregionwhere:
1. thecriterialistedinChapterAarecompliedwith,andtheBSEincidence
rate, calculated over the past 12 months, has been greater than one
hundred cases per million within the bovine animal population over 24
monthsofageinthecountryorregion;or
2. the BSE incidence rate, calculated over the past 12 months, has been
greater than or equal to one case per million and less than or equal to
one hundred cases per million within the bovine animal population over
24monthsofageinthecountryorregion,andatleastoneofthecriteria
listedinChapterAisnotcompliedwith.2001R0999—EN—01.01.2002—003.001—21
▼M1
ANNEX III
MONITORINGSYSTEM
CHAPTERA
I. MONITORINGINBOVINEANIMALS
1.General
Monitoring in bovine animals shall be carried out in accordance with
thelaboratorymethodslaiddowninAnnexX,ChapterC,point3.1(b).
2.Monitoringinanimalsslaughteredforhumanconsumption
2.1. Allbovineanimalsover24monthsofage:
— subject to ‘special emergency slaughtering’ as defined in Article
2(n)ofCouncilDirective64/433/EEC(1),or
— slaughteredinaccordancewithAnnexI,ChapterVI,point28(c),to
Directive64/433/EEC,
shallbetestedforBSE.
2.2. All bovine animals over 30 months of age subject to normal slaughter
forhumanconsumptionshallbetestedforBSE.
2.3. Bywayofderogationfrompoint2.2,andwithregardtobovineanimals
born, reared and slaughtered on their territory, Austria, Finland and
Sweden may decide to examine only a random sample. The sample
shallcompriseatleast10000animalsperyear.
3.Monitoringinanimalsnotslaughteredforhumanconsumption
Bovineanimals over24monthsofagewhichhavediedorbeenkilled
butwhichwerenot
— killed for destruction pursuant to Commission Regulation (EC) No
716/962(2),
— killed in the framework of an epidemic, such as foot-and-mouth
disease,
— slaughteredforhumanconsumption,
shallbetestedforBSEatrandom.Thenumberofsamplesshallnotbe
less than the sample size indicated in the table. The sampling mustbe
representativeforeachregionandcontinuous.
Totalpopulationover24months Samplesize(*)
100000 950
200000 1550
300000 1890
400000 2110
500000 2250600000 2360
700000 2440
800000 2500
900000 2550
1000000 2590
1500000 3000
2000000 3500
2500000 4000
3000000 4500
3500000 5000
4000000 55002001R0999—EN—01.01.2002—003.001—22
(1) OJ121,29.7.1964,p.2012/64.
(2) OJL99,20.4.1996,p.14.
▼M1
Totalpopulationover24months Samplesize(*)
4500000 6000
5000000 6500
5500000 7000
6000000 7500
6500000 8000
7000000 8500
7500000 9000
8000000 9500
8500000 10000
9000000 10500
9500000 11000
10000000 11500
10500000 12000
11000000 12500
11500000 13000
12000000 13500
(*) The sample size has been calculated to detect a prevalence of 0,1 % with a
95 % confidence in the subpopulation referred to in point 3, based on theassumption that the proportion of this subpopulation in the total popuolationofbovineanimalsover24monthsofageis1%.Wherethesizeofthetotal
population of bovine animals over 24 months of age is 1500 animals or
more,thesamplesizehasbeenincreasedby500samplesper500000animalsas a proportionality adjustment, to take account of the larger likelihood ofvariationinriskforBSEwithinthepopulation.
4.MonitoringinanimalspurchasedfordestructionpursuanttoRegu-
lation(EC)No716/96
4.1. All animals subject to casualty slaughter or found sick at ante-mortem
inspectionshallbetestedforBSE.
4.2. All animals born between 1 August 1996 and 1 August 1997 shall be
testedforBSE.
4.3. A random sample comprising at least 50000 animals annually of
animalsnotcoveredbypoints4.1or4.2shallbetestedforBSE.
5.Monitoringinotheranimals
In addition to the testing referred to in points 2 to 4, Member States
may on a voluntary basis decide to test other bovine animals on their
territory, in particular where those animals originate from countries
withindigenousBSE,haveconsumedpotentiallycontaminatedfeeding-
stuffsorwerebornorderivedfromBSEinfecteddams.
6.Measuresfollowingtesting
6.1. WhereananimalslaughteredforhumanconsumptionistestedforBSE,
thehealthmarkingprovidedforinChapterXIofAnnexItoDirective
64/433/EECshallnotbecarriedoutonthecarcaseofthatanimaluntil
anegativeresulttotherapidtesthasbeenobtained.
6.2. MemberStatesmayderogatefromtheprovisionsofpoint6.1wherean
official systemis in place in the slaughterhouse ensuring that no parts
of examined animals bearing the health mark leave the slaughterhouse
untilanegativeresulttotherapidtesthasbeenobtained.
6.3. All parts of the body of an animal tested for BSE including the hide
shall be retained under official control until a negative result to the
rapid test has been obtained, unless they are destroyed in accordance
withAnnexV,point3or4.
6.4. All parts of the body of an animal found positive to the rapid test
includingthehideshallbedestroyedinaccordancewithAnnexV,point
3 or 4, apart fromm aterial to be retained in conjunction with the
recordsprovidedforinChapterB,SectionIII.2001R0999—EN—01.01.2002—003.001—23
▼M1
6.5. Whereananimalslaughteredforhumanconsumptionisfoundpositive
to the rapid test, at least the carcase immediately preceding the test-
positive carcase and two carcases immediately following the test-posi-
tive carcase on the same slaughter line shall be destroyed in
accordancewithpoint6.4,inadditiontothetest-positivecarcase.
6.6. Member States may derogate fromthe provisionsofpoint 6.5wherea
systemis in place in the slaughterhouse preventing contam ination
betweencarcases.
II. MONITORINGINOVINEANDCAPRINEANIMALS
1.General
Monitoring in ovine and caprine animals shall be carried out in accor-
dance with the laboratory methods laid down in Annex X, Chapter C,
point3.2(b).
2.Monitoringinanimalsslaughteredforhumanconsumption
Animalsover18monthsofageslaughteredforhumanconsumptionshall
be tested in accordance with the sample size indicated in the table. The
sampling shall be representative foreach region and season.Thesample
selectionshallbedesignedwithaviewtoavoidtheover-representationof
any group as regards the origin, species, age, breed, production type or
anyothercharacteristic. Theageoftheanimalsshallbeestimated based
on dentition, obvious signs of maturity or other reliable information.
Multiplesamplinginthesameflockshallbeavoided,wherepossible.
Totalnumberofslaughteredanimals
over18monthsofageMinimumsamplesize,slaughtered
animals(*)
5000 4750
10000 7760
15000 9470
20000 10540
25000 11270
30000 1179040000 12490
50000 12940
60000 13260
70000 13490
80000 13660
90000 13800
100000 13910
150000 14250
200000 14430
250000 14540
300000 14610
350000 14660
400000 14700
450000 14730
500000 14760
600000 14790
700000 14820
800000 14840
900000 14850
1000000 14870
1100000 14880
1200000 14890
1300000 148902001R0999—EN—01.01.2002—003.001—24
▼M1
Totalnumberofslaughteredanimals
over18monthsofageMinimumsamplesize,slaughtered
animals(*)
1400000 14900
1500000 14900
1600000 14910
1700000 14910
1800000 149201900000 14920
2000000 14920
2100000 14920
2200000ormore 14930
(*) The sample size has been calculated to detect a prevalence of 0,02 % with a
95%confidenceinslaughteredanimals.
3.Monitoringinanimalsnotslaughteredforhumanconsumption
Animalsover18monthsofagewhichhavediedorbeenkilled,butwhich
werenot:
— killed in the framework of an epidemic, such as foot-and-mouth
disease,
— slaughteredforhumanconsumption,
shallbetestedinaccordance withthesample sizeindicated inthetable.
The sampling shall be representative for each region and season. The
sample selection shall be designed with a view to avoid the over-repre-
sentation of any group as regards the origin, species, age, breed,
production type or any other characteristic. The age of the animal shall
be estimated based on dentition, obvious signs of maturity or other reli-
able information. Multiple sampling in the same flock shall be avoided,
wherepossible.
Totalnumberofanimalsover18
monthsofage(*)Minimumsamplesize,dead
animals(**)
100000 950
200000 1550
300000 1890
400000 2110
500000 2250
600000 2360
700000 2440
800000 2500
900000 2550
1000000 2590
1500000ormore 3000
(*) Wherethetotalnumberofovineandcaprineanimalsover18monthsofageis
not known, the total number of ‘ewes and ewe-lambs put to the ram’ and‘goatswhichhavealreadykiddedandgoatsmated’shallbeusedinstead.
(**) The sample size has been calculated to detect a prevalence of 0,1 % with a
95%confidenceindeadanimals,basedontheassumptionthattheproportion
of dead animalsin the total population of ovine and caprine animals over 18monthsofageis1%.
4.MonitoringinMemberStateswithasmallovineandcaprinepopula-
tion
MemberStates,wherethetotalnumberofovineandcaprineanimalsover
18monthsofageis500000orlessmay,bywayofderogationfromthe2001R0999—EN—01.01.2002—003.001—25
▼M1
sampling foreseen in points 2 and 3, decide to monitor the following
combinedsubpopulation:
(a) animals over 18 months of age which have died or been killed, but
whichwerenot:
— killed in the framework of an epidemic, such as foot-and-mouth
disease,
— slaughteredforhumanconsumption(‘deadanimals’);and
(b) animalsover18monthsofagewhoseappearancesuggestsachronic
wastingcondition(‘chronicwastinganimals’).
The number of samples tested annually in each Member State from the
abovecombinedsubpopulationshallnotbelessthanthesamplesizeindi-
catedinthetable.
The sampling shall be representative for each region and season. The
sample selection shall be designed with a view to avoid the over-repre-
sentation of any group as regards the origin, species, age, breed,
production type or any other characteristic. Where dead animals are
sampled, the age of the animal shall be estimated based on dentition,
obvious signs of maturity or other reliable information. Where chronic
wastinganimalsaresampled,onlyanimalsinspectedbyanofficialveter-
inarianandforwhichtheageandclinicalsymptomsarewelldocumented
shallbeselectedforsampling.Multiplesamplinginthesameflockshall
beavoided,wherepossible.
Totalnumberofovineandcaprine
animalsover18monthsofage(*)Minimumsamplesize,deadand
chronicwastinganimals
10000 100
20000 200
30000 300
40000 400
50000 500
60000 600
70000 700
80000 800
90000 900
100000 950
200000 1550
300000 1890
400000 2110
500000 2250
(*) Wherethetotalnumberofovineandcaprineanimalsover18monthsofageis
notknown,thetotalnumberof‘ewesandewe-lambsputtotheram’and‘goatswhichhavealreadykiddedandgoatsmated’shallbeusedinstead.
5.Monitoringinotheranimals
In addition to the monitoring programmes set out in points 2 to 4,
Member States may on a voluntary basis carry out monitoring in other
animals,inparticular:
— animalsusedfordairyproduction,
— animalsoriginatingfromcountrieswithindigenousTSEs,
— animalswhichhaveconsumedpotentiallycontaminatedfeedingstuffs,
— animalsbornorderivedfromTSEinfecteddams,— animalsfromflocksinfectedwithTSE.
6.Measuresfollowingtestingofovineandcaprineanimals
All parts of the body of a tested animal including the hide shall be
retainedunderofficialcontroluntilanegativeresulttotherapidtesthas
been obtained, unless they are destroyed in accordance with Annex V,
point3or4.
All parts of the body of an animal found positive to the rapid test
includingthehideshallbedestroyedinaccordancewithAnnexV,point2001R0999—EN—01.01.2002—003.001—26
▼M1
3or4,apartfrommaterialtoberetainedinconjunctionwiththerecords
providedforinChapterB,sectionIII.
7.Genotyping
The prion protein genotype shall be determined for each positive TSE
caseinsheep.TSEcasesfoundinresistantgenotypes(sheepofgenotypes
whichencodealaninonbothallelesatcodon136,argininonbothalleles
atcodon154andargininonbothallelesatcodon171)shallimmediately
be reported to the Commission. Where possible, such cases shall be
submitted for strain-typing. Where strain-typing of such cases is not
possible, the herd of origin and all other herds where the animal has
beenshallbesubjectedtoenhancedmonitoringwithaviewtofindother
TSEcasesforstrain-typing.
CHAPTERB
I. INFORMATIONTOBEPRESENTEDBYMEMBERSTATESINTHEIR
REPORT
1. The number of suspected cases per animal species placed under move-
mentrestrictionsinaccordancewithArticle12(1).
2. The number ofsuspected cases per animal species subject to laboratory
examination in accordance with Article 12(2) and the outcome of the
examination.
3. The number of flocks where suspected cases in ovine and caprine
animals have been reported and investigated pursuant to Article 12(1)
and(2).
4. The estimated size of each subpopulation referred to in Chapter A,
SectionI,points3and4.
5. Thenumberofbovineanimalstestedwithineachsubpopulationreferred
toinChapterA,SectionI,point2to5,themethodforsampleselection
andtheoutcomeofthetests.
6. The estimated size of those subpopulations referred to in Chapter A,
SectionII,points2to4,whichhavebeenselectedforsampling.
7. Thenumberofovineandcaprine animalsandflockstestedwithineach
subpopulation referred to in Chapter A, Section II, points 2 to 5, the
methodforsampleselectionandtheoutcomeofthetests.
8. Number,age distribution and geographical distribution ofpositive cases
of BSE and scrapie. The country of origin, if not the same as the
reporting country, of positive cases of BSE and scrapie. Number and
geographicaldistributionofscrapiepositiveflocks.Theyearand,where
possible,monthofbirthshouldbegivenforeachBSEcase.
9. Positive TSE cases confirmed in animals other than bovine, ovine and
caprineanimals.
II. INFORMATION TO BE PRESENTED BY THE COMMISSION IN ITS
SUMMARY
The summary shall be presented in a tabled format covering at least the
informationreferredtoinPartIforeachMemberState.
III. RECORDS
1. Thecompetentauthorityshallkeep,forsevenyears,recordsof:
— thenumberandtypesofanimalsplacedundermovementrestrictions
asreferredtoinArticle12(1),
— the number and outcome of clinical and epidemiological investiga-
tionsasreferredtoinArticle12(1),
— thenumberandoutcomeoflaboratoryexaminationsasreferredtoin
Article12(2),
— thenumber,identityandoriginofanimalssampledintheframework
ofthemonitoringprogrammesasreferredtoinChapterAand,where
possible,age,breedandanamnesticinformation,
— theprionproteingenotypeofpositiveTSEcasesinsheep,— wherechronicwastingovineandcaprineanimalshavebeenselected
for sampling, the method to establish the age of and the clinical
symptomsobservedineachsampledanimal.2001R0999—EN—01.01.2002—003.001—27
▼M1
2. The investigating laboratory shall keep, for seven years, all records of
testing, in particular laboratory workbooks and, where appropriate,
paraffinblocksandphotographsofWesternblots.2001R0999—EN—01.01.2002—003.001—28
▼B
ANNEX IV
ANIMALFEEDING
1. In Member States or regions thereof placed in category 5, the prohibition
referredtoinArticle7(1)shallbeextendedto:
(a) thefeedingtoanyfarmedanimalofproteinderivedfrommammals;
(b) the feeding to any mammal of processed animal protein derived from
mammals; this prohibition shall not apply to feeding to dogs and cats
nortotheproductionofdogandcatfood;
(c) thefeedingtoanyruminantofrenderedruminantfat.
2. The prohibition laid down in Article 7(1) and (2) shall not apply to the
followingproductsfromhealthyanimals:
(a) milkandmilkproducts;
(b) gelatinederivedfromhidesandskins;
(c) hydrolysed proteins with a molecular weight below 10000 daltons
which:
(i) have been derived fromhides and skins obtained fromanim als
which have been slaughtered in a slaughterhouse and have under-
gone an ante mortem inspection by an official veterinarian in
accordance with Chapter VI of Annex I to Directive 64/433/EEC
and passed fit, as a result of such inspection, for slaughter for the
purposeofthatDirective,
and
(ii) havebeenproducedbyaproductionprocesswhichinvolvesappro-
priate measures to minimise contamination of hides and skins,
preparation of the hides and skins by brining, liming and intensive
washing followed by exposure of the material to a pH of more
than 11 for more than three hours at a temperature of more than
80 ºC and followed by heat treatment of more than 140 ºC for 30
minutesatmorethan3,6barorbyanequivalentproductionprocess
approved by the Commission after consultation of the appropriate
Scientific Committee in accordance with the procedure laid down
inArticle24(2),
and
(iii) come from establishments which carry out an own checks
programme(HACCP);
(d) dicalciumphosphate(withnotraceofproteinorfat);
(e) dried plasma and other blood products, with the exception of bovine
bloodproductsforfeedingtoruminants.2001R0999—EN—01.01.2002—003.001—29
▼B
ANNEX V
SPECIFIEDRISKMATERIAL
1. Thefollowingtissuesshallbedesignatedasspecifiedriskmaterialdepending
onthecategory oftheMemberState orthird countryoforigin orresidence
oftheanimal,determinedinaccordancewithArticle5:
CATEGORIES1AND2None.
CATEGORIES3AND4
(a) theskullincludingthebrainandeyes,thetonsilsandthespinalcordof
bovine animals aged over 12 months, and the intestines from the
duodenumtotherectumofbovineanimalsofallages;
(b) theskullincludingthebrainandeyes,thetonsilsandthespinalcordof
ovineandcaprineanimalsagedover12monthsorwhichhaveaperma-
nent incisor erupted through the gum, and the spleen of ovine and
caprineanimalsofallages.
CATEGORY5
(a) theentirehead(excludingthetongue),includingthebrain,eyes,trigem-
inal ganglia and tonsils; the thymus; the spleen and the spinal cord of
bovine animals aged over six months, and the intestines from the
duodenumtotherectumofanimalsofallages;
(b) the vertebral column, including dorsal root ganglia, of bovine animals
agedover30months;
(c) the skull including the brain and eyes, the tonsils, the spinal cord of
ovineandcaprineanimalsagedover12monthsorwhichhaveaperma-
nent incisor erupted through the gum, and the spleen of ovine and
caprineanimalsofallages.
2. Specifiedriskmaterialmustberemovedat:
(a) slaughterhouses;
(b) cuttingplants,high-riskprocessingplantsorpremisesreferredtoinArti-
cles 3 and 7 of Directive 90/667/EEC(
1), under the supervision of a
designated agent appointed by thecompetent authority. Thoseestablish-
mentsshallbeapprovedforthatpurposebythecompetentauthority.
However, the vertebral column may be removed at points of sale to the
consumersituatedintheterritoryoftheMemberStateconcerned.
Wherespecifiedriskmaterialisnotremovedfromdeadanimalswhichhave
not been slaughtered for human consumption, the parts of the body
containingspecifiedriskmaterialortheentirebodywillbetreatedasspeci-
fiedriskmaterial.
3. All specified risk material must be stained with a dye and, as appropriate,
markedwithamarkerimmediatelyonremoval,andcompletelydestroyed:
(a) byincinerationwithoutpre-processing;or,
(b) providedthatthedyeormarkerremainsdetectable,afterpre-processing:
(i) inaccordancewiththesystemsdescribedinChaptersItoIV,VIand
VIIoftheAnnextoDecision92/562/EEC(2):
— byincineration;
— byco-incineration;
(ii) in accordance with at least the standards referred to in Annex I to
Decision1999/534/EC(3),byburialinanapprovedlandfillsite.
4. MemberStatesmayderogatefromtheprovisionsofpoints2and3toallow
the incineration or burial ofspecified riskmaterial orentire bodies, without2001R0999—EN—01.01.2002—003.001—30
(1) CouncilDirective90/667/EECof27November1990layingdowntheveterinary rules
forthe disposal andprocessingofanimal waste, foritsplacing onthemarket andforthepreventionofpathogensinfeedstuffsofanimalorfishoriginandamendingDirec-tive90/425/EEC(OJL363,27.12.1990,p.51).Directiveaslastamendedbythe1994ActofAccession.
(
2) CommissionDecision92/562/EECof17November1992ontheapprovalofalternative
heat treatment systemsforprocessinghigh-riskmaterial (OJL359,9.12.1992,p.23).Decisionasamendedbythe1994ActofAccession.
(
3) CouncilDecision1999/534/ECof19July1999onmeasuresapplyingtotheprocessing
of certain animal waste to protect against transmissible spongiform encephalopathies
andamendingCommissionDecision97/735/EC(OJL204,4.8.1999,p.37).
▼B
prior staining, or, as appropriate, removal of the specified risk materials, in
the circumstances set out in Article 3(2) of Directive 90/667/EEC and by a
method which precludes all riskof transmission of a TSE and is authorised
andsupervisedbythecompetentauthority,inparticularwhereanimalshave
died or have been killed in the context of disease control measures and
withoutprejudicetoArticles12and13.
5. Theuseofanalternativetesttotheremovalofspecifiedriskmaterialmaybe
authorisedunderthefollowingconditions:
(a) testsmustbecarriedoutinslaughterhousesonallanimalseligibleforthe
removalofspecifiedriskmaterial;
(b) no bovine, ovine or caprine product intended for human foodor animal
feed may leave the slaughterhouse before the competent authority has
received and accepted the results ofthe testson all slaughtered animals
potentiallycontaminatedifBSEhasbeenconfirmedinoneofthem;
(c) when an alternative test gives a positive result, all bovine, ovine and
caprine material whichhasbeen potentially contaminated in the slaugh-
terhouse is destroyed in accordance with point 3, unless all parts of the
bodyincludingthehideoftheaffectedanimalcanbeidentifiedandkept
separate.
6. Member States are to carry out frequent official inspections to verify the
correctapplicationofthisAnnexandensurethatmeasuresaretakentoavoid
contamination, particularly in slaughterhouses, cutting plants, animal waste
processing plants, high risk processing plants or premises authorised by the
MemberStatesinaccordancewithArticle7ofDirective90/667/EEC,points
ofsaletotheconsumer,landfillsitesandotherfacilitiesforstorageorincin-
eration.
7. MemberStatesshallinparticularsetupasystemtoensureandcheckthat:
(a) specified risk material used in the production of products referred to in
Article1(2)areusedsolelyfortheauthorisedpurpose;
(b) wherebovine,ovineorcaprineanimalsenteraMemberStateplacedina
numerically lower category, indicating a better BSE status, than that of
the animals that enter, those animals remain under official supervision
untilslaughterordispatchfromitsterritory;
(c) specifiedriskmaterial, inparticular wheredisposaltakesplace atestab-
lishmentsorpremisesotherthanslaughterhouses,iscompletelyseparated
fromotherwastenotdestinedforincineration,iscollectedseparatelyand
isdisposedofinaccordancewithpoints2,3and4.MemberStatesmay
allowdispatchofheadsorcarcassescontainingspecifiedriskmaterialto
anotherMemberStateafteragreementwiththatotherMemberStateboth
toreceivethematerialandtoapplythespecificconditionsapplicable to
suchmovements.
8. Member States may send specified risk material or the material processed
therefromtootherMem berStatesforincineration onlyundertheconditions
laiddowninArticle4(2)ofDecision97/735/EC(1),whereapplicable.
ThesepointsmaybeamendedattherequestofaMemberStatetoallowthe
dispatch of specified risk material or the material processed therefrom to
third countries for incineration. The conditions governing export shall be
adoptedatthesametime,bythesameprocedure.2001R0999—EN—01.01.2002—003.001—31
(1) Commission Decision 97/735/EC of 21 October 1997 concerning certain protection
measureswithregardtotradeincertaintypesofmammalian animalwaste(OJL294,28.10.1997,p.7).Decisionasamended byCouncilDecision1999/534/EC(OJL204,
4.8.1999,p.37).
▼B
ANNEX VI
STANDARDS FOR CERTAIN PRODUCTS OF ANIMAL ORIGIN
DERIVEDFROMORCONTAININGRUMINANTMATERIAL
The use of ruminant material for the production of the following products of
animaloriginisprohibitedasreferredtoinArticle9(1):
(a) mechanicallyrecoveredmeat;
(b) dicalciumphosphateintendedasfeedingstuffsforlivestock;
(c) gelatine,unlessitisproducedfromruminanthides;
(d) derivativesmadefromrenderedruminantfat;
(e) renderedruminantfat,unlessitwasproducedfrom:
(i) discreteadiposetissuedeclaredfitforhumanconsumption;
(ii) raw materials which were processed in accordance with the standards
referredtoinDirective90/667/EEC.2001R0999—EN—01.01.2002—003.001—32
▼M2
ANNEX VII
ERADICATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALO-
PATHY
1. TheinquiryreferredtoinArticle13(1)(b)mustidentify:
(a) inthecaseofbovineanimals:
— allotherruminantsontheholdingoftheanimalinwhichthedisease
wasconfirmed,
— wherethediseasewasconfirmedinafemaleanimal,allitsembryos,
ova and its progeny collected or born within two years prior to, or
after,clinicalonsetofthedisease,
— all animals of the cohort of the animal in which the disease was
confirmed,
— thepossibleoriginofthedisease,— otheranimals,embryosorova,ontheholdingoftheanimalinwhich
the disease was confirmed or on other holdings, which may have
becomeinfectedbytheTSEagentorbeenexposedtothesamefeed
orcontaminationsource,
— the movement of potentially contaminated feedingstuffs, of other
material orany other means of transmission, which may have trans-
mittedtheTSEagenttoorfromtheholdinginquestion;
(b) inthecaseofovineandcaprineanimals:
— allruminantsotherthanovineandcaprineanimalsontheholdingof
theanimalinwhichthediseasewasconfirmed,
— insofarastheyareidentifiable,theparents,allembryos,ovaandthe
lastprogenyoftheanimalinwhichthediseasewasconfirmed,
— allanimalsofthecohort,tobedefinedinaccordancewiththeproce-
dure laid down in Article 24(2), of the animal in which the disease
wasconfirmed,
— all other ovine and caprine animals on the holding of the animal in
which the disease was confirmed in addition to those mentioned in
thesecondandthirdindents,
— thepossibleoriginofthediseaseandtheidentificationofotherhold-
ings on which there are animals, embryos or ova which may have
becomeinfectedbytheTSEagentorbeenexposedtothesamefeed
orcontaminationsource,
— the movement of potentially contaminated feedingstuffs, other mate-
rialoranyothermeansoftransmission,whichmayhavetransmitted
theBSEagenttoorfromtheholdinginquestion.
2. ThemeasureslaiddowninArticle13(1)(c)shallcompriseatleast:
(a) in case of confirmation of BSE in a bovine animal, the killing and
complete destruction of bovine animals and the destruction of embryos
and ova identified by the inquiry referred to in point 1(a), first, second
and third indent. The Member State may decide not to kill and destroy
all bovine animals on the holding of the animal in which the disease
wasconfirmed asreferred tointhefirstindent ofpoint1(a),depending
upontheepidemiologicalsituationandtraceabilityoftheanimalsonthat
holding;
(b) incaseofconfirmationofBSEinanovineorcaprineanimal,killingand
complete destruction of all animals, embryos and ova identified by the
inquiryreferredtoinpoint1(b),secondtosixthindents.2001R0999—EN—01.01.2002—003.001—33
▼B
ANNEX VIII
PLACINGONTHEMARKETANDEXPORT
CHAPTERA
Conditionsforintra-Communitytradeinlive animals,embryosandova
I. CONDITIONS WHICH APPLY IRRESPECTIVE OF THE CATEGORY
OFTHEMEMBERSTATEORTHIRDCOUNTRYOFORIGINORRESI-
DENCEOFTHEANIMAL
1. DispatchtootherMemberStatesmustfollowtherulesofArticle15(1).2. Thefollowingconditionsshallapplytothemovementofbovineembryos
andova:
Bovineembryosandovamustbederivedfromfemaleanimalswhich,at
thetimeofcollection:
— werenotsuspectedofbeinginfectedbyBSE;
— themselvescompliedwiththeconditionslaiddowninPartII.
3. The following conditions shall apply to trade in ovine and caprine
animals:
(a) Ovineandcaprineanimalsforbreedingmust:
(i) comefromaholdingsatisfyingthefollowingrequirements:
— itissubjecttoregularofficialveterinarychecks;
— theanimalsaremarked;
— no case of scrapie has been confirmed for at least three
years;
— checking by sampling is carried out on the holding on old
femaleanimalsintendedforculling;
— females are introduced into that holding only if they come
fromaholdingwhichcomplieswiththesamerequirements;
(ii) havebeencontinuouslykeptonaholdingorholdingscomplying
withtherequirementslaiddowninpoint(i)sincebirthorforthe
lastthreeyears;
(iii) iftheyaredestinedforaMemberStatewhichbenefits,forallor
part of its territory, fromthe provisions laid down in point (b),
comply with the guarantees provided for in the programmes
referredtointhatpoint.
(b) A Member State which has a compulsory or voluntary national
scrapiecontrolprogrammeforallorpartofitsterritory:
(i) maysubmitthesaidprogrammetotheCommission,outliningin
particular:
— thedistributionofthediseaseintheMemberState;
— thereasonsfortheprogramme,takingintoconsiderationthe
importanceofthediseaseandthecost/benefitratio;
— thegeographicalareainwhichtheprogrammewillbeimple-
mented;
— the status categories to be applied to the holdings, the stan-
dards which must be attained in each category and the test
procedurestobeused;
— theprogrammemonitoringprocedures;— the action to be taken if, for any reason, a holding loses its
status;
— themeasures tobetaken ifthe resultsofchecks carried out
inaccordancewiththeprovisionsoftheprogrammeareposi-
tive;
(ii) the programmes referred to in point (i) may be approved in
compliance with the criteria laid down in that point in accor-
dance with the procedure referred to in Article 24(2).
According to the same procedure, the additional guarantees,
general or specific, which may be required in intra-Community
trade, shall be defined at the same time or at the latest three
monthsafterapprovaloftheprogrammes.Suchguaranteesmust
notexceedthosewhichtheMemberStateimplementsnationally;
(iii) programmes submitted by Member States may be amended or
supplemented in accordance with the procedure referred to in
Article 24(2). According to the same procedure, an amendment2001R0999—EN—01.01.2002—003.001—34
▼B
oranadditiontoaprogrammewhichhasalreadybeenapproved
or to guarantees which have been defined in accordance with
subparagraph(ii)maybeapproved.
(c) WhereaMemberStateconsidersthatitsterritoryorpartofitsterri-
toryisfreefromovinescrapie:
(i) it is to submit to the Commission appropriate supporting docu-
mentation,settingoutinparticular:
— thehistoryoftheoccurrenceofthediseaseinitsterritory;
— the results of surveillance testing based on serological,
microbiological, pathological or epidemiological investiga-
tion;
— theperiodoverwhichthesurveillancewascarriedout;
— thearrangementsforverifyingtheabsenceofthedisease;
(ii) the additional guarantees, general or specific, which may be
required in intra-Community trade are to be defined in accor-
dance with the procedure referred to in Article 24(2). Such
guarantees must not exceed those which the Member State
implementsnationally;
(iii) theMemberStateconcernedistonotifytheCommissionofany
change in the details specified in point (i) which relate to the
disease. The guarantees defined in accordance with point (ii)
may,inthelightofsuchnotification,beamendedorwithdrawn
inaccordancewiththeprocedurereferredtoinArticle24(2).
II. CONDITIONS WHICH APPLY DEPENDING ON THE CATEGORY OF
THEMEMBERSTATEOFORIGINORRESIDENCEOFTHEANIMAL
DETERMINEDINACCORDANCEWITHANNEXII,CHAPTERC
1. DispatchtootherMemberStatesistofollowtherulesofArticle15(1).
2. The BSE category of the Member State of origin of bovine, ovine and
caprineanimalsaretobecommunicatedtotheMemberStateofdestina-
tion.
3. The following conditions are to apply to movements as referred to in
point1ofbovineanimalscomingfromorhavingresidedintheMember
Statesoroneoftheregionsthereofplacedin:
CATEGORIES3AND4Theanimalsmusthave:
(a) been born, raised and have remained in herds in which no case of
BSEhasbeenconfirmedforatleastsevenyears;or
(b) beenbornafterthedatefromwhichthebanonthefeedingofrumi-
nants with proteins derived from mammals has been effectively
enforced.
CATEGORY5
Theanimalsmusthave:
(a) beenbornafterthedatefromwhichthebanonthefeedingoffarmed
animals with proteins derived from mammals has been effectively
enforced;and
(b) been born, raised and have remained in herds in which no case of
BSEhasbeen confirmed for at least sevenyears, and whichcontain
only bovine animals born on the farm or coming from a herd of
equivalentstatus.
CHAPTERB
Conditions relating to progeny of TSE suspect or confirmed animals
referred toinArticle15(2)
It shall be prohibited to place on the market the last-born progeny to which
femalebovineanimalsinfectedwithaTSEorBSE-confirmedovineorcaprine
animals gave birth during the preceding two-year period or during the period
that followed the appearance of the first clinical signs of the onset of the
disease.2001R0999—EN—01.01.2002—003.001—35
▼B
CHAPTERC
Conditionsforintra-Communitytradeincertainproductsofanimalorigin
I. The following products of animal origin are exempt from the prohibition
referred to in Article 16(3), provided that they are derived frombovine
animalsthatsatisfytherequirementsofPartsIIorIIIbelow:
— freshmeat;
— mincedmeat;
— meatpreparations;
— meatproducts;
— petfoodwhichisdestinedfordomesticcarnivores.
Date-based Scheme
II. Deboned fresh meat from which all adherent tissues, including obvious
nervous and lymphatic tissue, has been removed, and products of animal
originreferredtoinPartIderivingtherefromobtainedfromeligibleanimals
fromcountriesorregionsincategory5maybemarketedinaccordancewith
the second subparagraph of Article 16(3) when they are obtained from
animals born after the date from which the animal feeding standards laid
downinArticle7(2)wereeffectivelyenforcedandcertifiedasmeetingthe
conditions laid down in point 1 and they are produced in establishments
which meet the condition laid down in point 9. The competent authority
shallensurethattheconditionswithrespecttocontrolslaiddowninpoints
2to8andpoint10arecompliedwith.
1. Abovine animal shall be eligible forthe Date-based Scheme if it was
born and raised in the Member State concerned and if at the time of
slaughteritisshownthatthefollowingconditionsarefulfilled:
(a) theanimalhasbeenclearlyidentifiablethroughoutitslife,enabling
ittobetracedbacktoitsdamandherdoforigin;itsuniqueeartag
number,dateandholdingofbirthandallmovementsafterbirthare
recorded either in the animal's official passport or in an official
computerised identification and tracing system; the identity of its
damisknown;
(b) theanimalismorethansixmonthsbutlessthan30monthsofage,
determinedbyreferencetoanofficialcomputerrecordofitsdateof
birth,ortotheanimal'sofficialpassport;
(c) thecompetentauthorityhasobtainedandverifiedpositiveevidence
thatthedamoftheanimalhaslivedforatleastsixmonthsafterthe
birthoftheeligibleanimal;
(d) thedamoftheanimalhasnotdevelopedBSEandisnotsuspected
ofhavingcontractedBSE.
Controls
2. If any animal presented for slaughter or any circumstance surrounding
its slaughter does not meet all of the requirements of this Regulation,
theanimal mustbeautomatically rejected anditspassportconfiscated.
If that information becomes available after slaughter, the competent
authoritymustimmediatelyceaseissuingcertificatesandcancelcertifi-
cates issued. If dispatch has already taken place, the competent
authority must notify the competent authority of the place of destina-
tion.Thecompetentauthorityoftheplaceofdestinationmusttakethe
appropriatemeasures.
3. Slaughterofeligible animalsmusttakeplaceinslaughterhouseswhich
are not used for the slaughter of bovine animals other than those
slaughtered under a Date-based Scheme or under a Certified Herd
Scheme.
4. Thecompetent authority mustsatisfyitselfthat proceduresusedinthe
cutting plants ensure that the following lymph nodes have been
removed:
popliteal, ischiatic, superficial inguinal, deep inguinal, medial and
lateral iliac, renal, prefemoral, lumbar, costocervical, sternal, prescap-
ular,axilliary,caudalanddeepcervical.
5. Meatmustbetraceable backtotheeligible animal, oraftercutting,to
the animals cut in the same batch, by means of an official tracing
system until the time of slaughter. After slaughter, labels must be
capableoftracingfreshmeatandproductsreferredtoinPartIbackto
theeligibleanimaltoenabletheconsignmentconcernedtoberecalled.
In the case of petfood, accompanying documents and records must
allowtracing.2001R0999—EN—01.01.2002—003.001—36
▼B
6. All approved eligible carcasses must have individual numbers corre-
latedwiththeeartagnumber.
7. TheMemberStatemusthavedetailedprotocolsinplacecovering:
(a) tracingandcontrolspriortoslaughter;
(b) controlsduringslaughter;
(c) controlsduringprocessingofpetfood;
(d) all labelling and certification requirements after slaughter to the
pointofsale.
8. Thecompetent authoritymustsetupasystemforrecordingcheckson
compliancesothatcontrolcanbedemonstrated.
Theestablishment
9. To obtain approval, the establishment must devise and implement a
systemwherebytheeligiblemeatand/oreligibleproductisidentifiable
andallmeatcanbetracedbacktotheeligibleanimal,oraftercutting,
totheanimalscutinthesamebatch.Thesystemmustallowfulltrace-
abilityofthemeatorproductsofanimaloriginatallstagesandrecords
mustberetainedforatleasttwoyears.Detailsofthesystememployed
must be given, in writing, by the management of the establishment to
thecompetentauthority.
10. The competent authority must assess, approve and monitor the system
provided by the establishment in order to ensure that it provides full
segregationandtraceabilitybothbackwardsandforwards.
Certified herd Scheme
III. Deboned fresh meat from which all adherent tissues, including obvious
lymphatic and nervous tissue, has been removed, and products of animal
origin referred to in Part I, deriving therefromwhich are obtained from
eligible animals from countries or regions in category 5,may be marketed
inaccordancewiththesecondsubparagraphofArticle16(3)whenobtained
from animals which are certified as meeting the conditions laid down in
point 2 and coming from herds in which no case of BSE has occurred in
the last seven years and which are certified as meeting the conditions laid
down in point 1 and produced in establishments which meet the condition
laiddowninpoint11.Thecompetentauthorityshallensurethatthecondi-
tions laid down in points 3 to 10 and 12 with respect to the computerised
tracingsystemandthecontrolsarecompliedwith.
Conditionsrelatingtoherds
1. (a) A herd is a group of animals forming a separate and distinct unit,
thatisagroupofanimalswhichismanaged,housedandkeptsepa-
ratelyfromanyothergroupofanimalsandwhichisidentifiedwith
uniqueherdandanimalidentificationnumbers.
(b) A herd is eligible when for at least seven years there hasbeen no
confirmedcaseofBSE,norasuspectcaseforwhichthediagnosis
ofBSEhasnotbeenruledout,inanyanimalwhichwasstillinor
hadmovedthroughorfromtheherd.
(c) Asanexceptiontotheprovisionsinpoint(b),aherdthathasbeen
in existence for less than seven years may be considered eligible,
after a thorough investigation by the competent veterinary
authority,onconditionthat:
(i) all animals born or moved into the newly established herd
complied with the conditions set out in point (2)(a), (d) and
(e);and,
(ii) the herd has complied with the conditions set out in point (b)
duringitsentireexistence.
(d) If a herd is newly established on a holding which experienced a
confirmed case of BSE in any animal which was still in or had
moved through or from a herd on that holding, the newly estab-lished herd can only be eligible after a thorough investigation by
the competent veterinary authority, certifying compliance with
eachofthefollowingconditionstothesatisfactionofthatauthority:
(i) all animals of the affected herd previously held on the same
holdinghavebeenremovedorkilled;
(ii) all feed has been removed and destroyed and all feed
containersthoroughlycleansed;
(iii) all buildings have been emptied and thoroughly cleansed
beforethenewanimalswereadmitted;
(iv) allconditionssetoutinpoint(c)havebeencompliedwith.2001R0999—EN—01.01.2002—003.001—37
▼B
Conditionsrelatingtotheanimal
2. (a) all records of the animal's birth, identity and movements are
recordedonanofficialcomputerisedtracingsystem;
(b) theanimalismorethansixmonthsbutlessthan30monthsofage,
determinedbyreferencetoanofficialcomputerrecordofitsdateof
birth;
(c) itsdamhaslivedforatleastsixmonthsafteritsbirth;
(d) its damhas not developed BSE and is not suspected of having
contractedBSE;
(e) the herd of birth of the animal and all herds through which it has
movedareeligible.
Computerisedtracingsystem
3. The official computerised tracing system referred to in point 2(a) will
be approved only where it hasbeen in operation for sufficient time to
contain all the information, relating to the lifetime and movements of
theanimals, neededtocheck compliance withtherequirements ofthis
Regulation,andconcernsonlyanimalsbornafterthesystemcameinto
operation.Historicaldataloadedintoacomputerforanyperiodbefore
thesystemwasoperationalwillnotbeacceptedforthispurpose.
Controls
4. If any animal presented for slaughter or any circumstance surrounding
its slaughter does not meet all of the requirements of this Regulation,
theanimal mustbeautomatically rejected anditspassportconfiscated.
If that information becomes available after slaughter, the competent
authority mustimmediately cease issuingcertificates, and cancel certi-
ficates issued. If dispatch has already taken place, the competent
authority must notify the competent authority of the place of destina-
tion.Thecompetentauthorityoftheplaceofdestinationmusttakethe
appropriatemeasures.
5. Slaughter of eligible animals must take place in slaughterhouses used
exclusivelyfortheslaughterofanimalsunderaDate-basedSchemeor
underaCertifiedHerdScheme.
6. Thecompetent authority mustsatisfyitselfthat proceduresusedinthe
cutting plants ensure that the following lymph nodes have been
removed:
popliteal, ischiatic, superficial inguinal, deep inguinal, medial and
lateral iliac, renal, prefemoral, lumbar, costocervical, sternal, prescap-
ular,axilliary,caudalanddeepcervical.
7. Meatmustbetraceablebacktotheherdoftheeligibleanimal,orafter
cutting,totheanimals cutinthesamebatch, bymeans ofthecompu-
terisedtracingsystemuntilthetimeofslaughter.Afterslaughter,labels
mustbecapableoftracingfreshmeatandproductsreferredtoinPartI
backtotheherdtoenabletheconsignmentconcernedtoberecalled.Inthe case of petfood, accompanying documents and records must allow
tracing.
8. All approved eligible carcasses must have individual numbers corre-
latedwiththeeartagnumber.
9. TheMemberStatemusthavedetailedprotocolsinplacecovering:
(a) tracingandcontrolspriortoslaughter;
(b) controlsduringslaughter;
(c) controlsduringprocessingofpetfood;
(d) all labelling and certification requirements after slaughter to the
pointofsale.
10. Thecompetent authoritymustsetupasystemforrecordingcheckson
compliancesothatcontrolcanbedemonstrated.
Theestablishment
11. To obtain approval, the establishment must devise and implement a
systemwherebytheeligiblemeatand/oreligibleproductisidentifiable
andallmeatcanbetracedbacktoitsherdsoforigin,oraftercutting,to
theanimalscutinthesamebatch.Thesystemmustfacilitatefulltrace-
abilityofthemeatorproductsofanimaloriginatallstagesandrecords
mustberetainedforatleasttwoyears.Detailsofthesystememployed
must be given, in writing, by the management of the establishment to
thecompetentauthority.2001R0999—EN—01.01.2002—003.001—38
▼B
12. The competent authority must assess, approve and monitor the system
provided by the establishment in order to ensure that it provides full
segregationandtraceabilitybothbackwardsandforwards.
CHAPTERD
Conditionsapplicabletoexports
Livebovineanimals andproductsofanimaloriginderived therefrom aretobe
subject—asregardsexportstothirdcountries—totheruleslaiddowninthis
Regulationforintra-Communitytrade.2001R0999—EN—01.01.2002—003.001—39
▼B
ANNEX IX
IMPORTATION INTO THE COMMUNITY OF LIVE ANIMALS,
EMBRYOS,OVAANDPRODUCTSOFANIMALORIGIN
CHAPTERA
When importing from countries orregionsplaced incategory 1,thecompetent
authorityis,forbovineanimalsandallcommoditiesofbovineoriginforwhich
this Regulation lays downspecific rules, totake account ofthe presentation of
an international animal health certificate attesting that the country or region
complieswiththeconditionsinAnnexII,ChapterC,tobeplacedinthatcate-
gory.
CHAPTERB
Importsofbovineanimals
A. Imports of bovine animals from a country or a region placed in category 2
aretobesubjecttothepresentationofaninternationalanimalhealthcertifi-
cateattestingthat:
(a) thefeedingofruminantswithproteinsderivedfrommammalshasbeen
bannedandthebanhasbeeneffectivelyenforced;
(b) thebovineanimalsintendedforexporttotheCommunityareidentified
byapermanentidentificationsystemenablingthemtobetracedbackto
the damand herd of origin and are not the progeny of BSE-suspected
females.
B. Importsofbovineanimalsfromcountriesorregionsplacedincategory3are
tobesubjecttothepresentationofaninternationalanimalhealthcertificate
attestingthat:
1. the feeding of ruminants with proteins derived from mammals has been
bannedandthebanhasbeeneffectivelyenforced;
2. bovineanimalsintendedforexporttotheCommunity:
— are identified by a permanent identification system enabling them to
be traced back tothe damand herdoforigin and making it possible
toestablishthattheyarenottheprogenyofBSEsuspectorconfirmed
females;
— wereborn,raisedandhadremainedinherdsinwhichnocaseofBSE
hadbeenconfirmedforatleastsevenyears;or
— werebornafterthedatefromwhichthebanonthefeedingofrumi-
nants with proteins derived from mammals has been effectively
enforced.
C. Importsofbovineanimalsfromcountriesorregionsplacedincategory4are
tobesubjecttothepresentationofaninternationalanimalhealthcertificate
attestingthat:
1. the feeding of ruminants with proteins derived from mammals has been
bannedandthebanhasbeeneffectivelyenforced;
2. bovineanimalsintendedforexporttotheCommunity:
(a) are identified by apermanent identification systemenabling them to
betracedbacktothedamandherdoforiginandmakingitpossible
to establish that they are not the progeny of BSE suspect or
confirmedfemales;and
(b) were born, raised and have remained in herds in which no case of
BSEhasbeenconfirmedforatleastsevenyears;or
(c) werebornafterthedatefromwhichthebanonthefeedingofrumi-
nants with proteins derived from mammals has been effectively
enforced.
D. Importsofbovineanimalsfromcountriesorregionsplacedincategory5are
tobesubjecttothepresentationofaninternationalanimalhealthcertificate
attestingthat:
1. the feeding of farmed animals with proteins derived from mammals has
beenbannedandthebanhasbeeneffectivelyenforced;
2. the affected bovine animals are killed and completely destroyed as well
as:
(a) ifthesearefemales,theirlastprogenybornwithintwoyearspriorto,
orafterthefirstclinicalsignsoftheonsetofthedisease;2001R0999—EN—01.01.2002—003.001—40
▼B
(b) allbovineanimalsfromthesamecohort
ifsuchanimalsarestillaliveinthecountryorregion;
3. theanimalsintendedforexporttotheCommunity:
(a) werebornafterthedatefromwhichthebanonthefeedingoffarmed
animals with proteins derived from mammals was effectively
enforced;
(b) are identified by apermanent identification systemenabling them to
betracedbacktothedamandherdoforiginandarenottheprogeny
ofBSEsuspectorconfirmedfemales;
AND
(c) eitherwereborn,raisedandhaveremainedinherdsinwhichnocase
of BSE has ever been confirmed, and which contain only bovine
animals born on the farm or coming from a herd of equal health
status;or
(d) were born, raised and have remained in herds in which no case of
BSEhasbeen confirmed foratleast sevenyears,andwhichcontain
onlybovineanimalsbornonthefarmorcomingfromaherdofequal
healthstatus.
CHAPTERC
Importsoffreshmeatandproductsofbovineanimalorigin
A. Imports of fresh meat (on the bone or deboned) and products of bovine
animal origin from countries or regions placed in category 2 are to be
subjecttothepresentationofaninternationalhealthcertificateattestingthat
the feeding of ruminants with proteins derived from mammals has been
bannedandthebanhasbeeneffectivelyenforced.
B. Imports of fresh meat (on the bone or deboned) and products of bovine
animal origin from countries or regions placed in category 3 are to be
subjecttothepresentationofaninternationalhealthcertificateattestingthat:
(a) thefeedingofruminantswithproteinsderivedfrommammalshasbeen
bannedandthebanhasbeeneffectivelyenforced;
(b) thefreshmeatandproductsofbovineanimaloriginintendedforexport
totheCommunitydonotcontainorarenotderivedfromspecifiedrisk
material referred to in Annex V or mechanically recovered meat
obtainedfromtheboneoftheheadorvertebralcolumn.
C. Importsoffreshmeat(ontheboneordeboned)andmeatproductsofbovine
originfromcountriesorregionsplacedincategory4aretobesubjecttothe
presentationofaninternationalhealthcertificateattestingthat:
1. the feeding of ruminants with proteins derived from mammals has been
bannedandthebanhasbeeneffectivelyenforced;
2. the fresh meat and products of bovine animal origin intended for export
to the Community do not contain or are not derived from specified risk
materialreferredtoinAnnexVormechanicallyrecoveredmeatobtained
fromtheheadorvertebralcolumn.
D. Imports of fresh meat and products of bovine animal origin from countries
orregionsplacedincategory5aretobeprohibitedexceptfortheproducts
ofanimaloriginlistedinsectionIofChapterC,AnnexVIII.Theseimports
are to be subject to the presentation of an international health certificate
attestingthat:
1. theyfulfiltheconditionsofArticle16(2)andthosesetoutinsectionsII
orIIIofChapterCofAnnexVIII;
2. the meat products intended for export to the Community do not contain
or are not derived fromany product referred to in Chapter F, nor from
anyspecifiedriskmaterialasdefinedinAnnexV;
3. a systemis in operation enabling the fresh m eat and products of bovine
animaloriginintendedforexporttotheCommunitytobetracedbackto
theestablishmentsfromwhichtheyarederived;
4. the bovine animals from which the meat or meat products intended for
exporttotheCommunityoriginate:
(a) wereidentifiedbyapermanentidentificationsystemenablingthemto
betracedbacktothedamandherdoforigin;2001R0999—EN—01.01.2002—003.001—41
▼B
(b) arenottheprogenyofBSE-suspectorconfirmedfemales;andeither:
— were born after the date fromwhich the ban on the feeding of
farmed animals with proteins derived from mammals was effec-
tivelyenforced;or
— wereborn,raisedandhaveremainedinherdsinwhichnocaseof
BSEhasbeenconfirmedforatleastsevenyears;
5. the feeding of farmed animals with proteins derived from mammals has
beenbannedandthebanhasbeeneffectivelyenforced;
6. the affected bovineanimals are slaughtered and completely destroyed as
wellas:
(a) ifthesearefemales,theirlastprogenybornwithintwoyearspriorto,
orafter,thefirstclinicalsignsoftheonsetofthedisease;
(b) allbovineanimalsfromthesamecohort
iftheyarestillaliveinthecountryorregion.
CHAPTERD
Importsofbovineembryosandova
A. Importsofbovineembryos/ovafromcountriesorregionsplacedincategory
2aretobesubjecttothepresentationofaninternationalanimalhealthcerti-
ficateattestingthat:
1. the feeding of ruminants with proteins derived from mammals has been
bannedandthebanhasbeeneffectivelyenforced;
2. theembryos/ovawerecollected,processedandstoredinconformitywith
theprovisionsofAnnexesAandBtoDirective89/556/EC(1).
B. Importsofbovineova/embryosfromcountriesorregionsplacedincategory
3aretobesubjecttothepresentationofaninternationalanimalhealthcerti-
ficateattestingthat:
1. the feeding of ruminants with proteins derived from mammals has been
bannedandthebanhasbeeneffectivelyenforced;
2. ova/embryos destined for export to the Community are derived from
femaleswhich:
(a) are identified by apermanent identification systemenabling them to
betracedbacktothedamandherdoforigin,andarenottheprogeny
ofBSE-confirmedfemales;
(b) arenottheprogenyofBSE-suspectorconfirmedfemales;
(c) were not suspected of being affected by BSE at the time of embryo
collection;
3. theova/embryoswerecollected,processedandstoredinaccordancewith
theprovisionsofAnnexesAandBtoDirective89/556/EEC.
C. Importsofova/embryosfromcountriesorregionsplacedincategory4areto
be subject to the presentation of an international animal health certificate
attestingthat:
1. the feeding of ruminants with proteins derived from mammals has been
bannedandthebanhasbeeneffectivelyenforced;
2. theova/embryosintendedforexporttotheCommunityarederivedfrom
femaleswhich:
(a) are identified by apermanent identification systemenabling them to
betracedbacktothedamandherdoforigin,andarenottheprogeny
ofBSE-suspectedoraffectedfemales;
(b) arenotaffectedwithBSE;
(c) werenotsuspectedofbeingaffectedwithBSEatthetimeofembryo
collection;and
(i) eitherwerebornafterthedatefromwhichthebanonthefeeding
of ruminants with proteins derived from mammals was effec-
tivelyenforced;or
(ii) wereborn,raisedandhaveremainedinherdsinwhichnocaseof
BSEhasbeenconfirmedforatleastsevenyears;2001R0999—EN—01.01.2002—003.001—42
(1) Council Directive 89/556/EEC of 25 September 1989 on animal health conditions
governing intra-Community trade in importation from third countries of embryos ofdomestic animalsofthebovinespecies(OJL302,19.10.1989,p.1).Directive aslast
amendedbyCommissionDecision94/113/EC(OJL53,24.2.1994,p.23).
▼B
3. theova/embryoswerecollected,processedandstoredinconformitywith
theprovisionsofAnnexesAandBtoDirective89/556/EEC.
D. Importsofbovineova/embryosfromcountriesorregionsplacedincategory
5aretobesubjecttothepresentationofaninternationalanimalhealthcerti-
ficateattestingthat:
1. thefeedingofanimalsforbreedingwithproteinsderivedfrommammals
hasbeenbannedandthebanhasbeeneffectivelyenforced;
2. theaffected bovineanimals, and,if theseare females, their last progeny
born within two years prior to, or after, clinical onset of the disease, if
aliveinthecountryorregion,arekilledandcompletelydestroyed;
3. ova/embryos intended for export to the Community are derived from
femaleswhich:
(a) are identified by apermanent identification systemenabling them to
betracedbacktothedamandherdoforigin,andarenottheprogeny
ofBSE-suspectedorconfirmedfemales;
(b) arenotaffectedwithBSE;
(c) werenotsuspectedofbeingaffectedwithBSEatthetimeofembryo
collection;and
(i) eitherwerebornafterthedatefromwhichthebanonthefeeding
ofanimalsforbreedingwithproteinsderivedfrommammalswas
effectivelyenforced;
(ii) orhaveneverbeenfedwithproteinsderivedfrommammalsand
wereborn,raisedandhaveremainedinherdsinwhichnocaseof
BSE has been confirmed for at least seven years, and which
contain onlybovineanimalsbornonthefarmorcomingfroma
herdofequalhealthstatus;
4. the ova/embryos were collected, processed and stored strictly in confor-
mitywiththeprovisionsofAnnexesAandBtoDirective89/556/EEC.
CHAPTERE
Importsofovineandcaprineanimals
Ovine and caprine animals imported into the Community are to meet the
requirements which provide health guarantees equivalent to those required by
thisRegulationorpursuanttothisRegulation.
CHAPTERF
Imports into the Community from third countries or regions thereof, placed in
category5,oftheproductsofanimaloriginreferredtoinAnnexVIII,Chapter
C, in accordance with Article 16(3) are to be prohibited if they contain or are
derivedfromthefollowingproductsormaterialderivedfromruminantanimals:
— mechanicallyrecoveredmeat;
— dicalciumphosphateintendedforfeedinglivestock;— gelatineunlessproducedfromhidesorskins;— rendered ruminant fat and derivatives made from it unless they were
produced fromdiscrete adipose tissue which was itself declared fit for
humanconsumption,orfromrawmaterials whichwereprocessedinaccor-dancewiththestandardsreferredtoinDecision1999/534/EC.
CHAPTERG
When importing products of animal origin from third countries or regions
thereof which are not placed in category 1, the appropriate certificates, as
required by Community legislation, are to be supplemented by a declaration
signed by the competent authority of the country of production, worded as
follows:
‘The product of animal origin does not contain, and is not derived from,
specified risk material as defined in Annex Vto Regulation (EC) No999/
2001oftheEuropeanParliamentandoftheCouncilof22May2001laying
down rules for the prevention, control and eradication of certain transmis-
sible spongiform encephalopathies or mechanically recovered meat
obtained from bones of the head or vertebral column of bovine animals.
The animals have not been slaughtered after stunning by means of a gas
injectedintothecranialcavityorkilledinstantaneouslybythesamemethod
or slaughtered by laceration after stunning of central nervous tissue by
means of an elongated rod-shaped instrument introduced into the cranial
cavity.’2001R0999—EN—01.01.2002—003.001—43
▼B
ANNEX X
REFERENCE LABORATORIES, SAMPLING AND LABORATORY
ANALYSISMETHODS
CHAPTERA
Nationalreference laboratories
1. Thedesignatednationalreferencelaboratoryisto:
(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,
thetypeandstrainoftheagentofTSE,andtoconfirmresultsobtained
by regional diagnostic laboratories. Where it is not capable of identi-
fyingthestrain-typeoftheagent,itshallsetupaproceduretoensure
thattheidentification ofthestrainisreferredtotheCommunityrefer-
encelaboratory;
(b) verifydiagnosticmethodsusedinregionaldiagnosticlaboratories;
(c) be responsible for coordination of diagnostic standards and methods
withintheMemberState.Tothisend,it:
— may provide diagnostic reagents to laboratories approved by the
MemberState;
— is to control the quality of all diagnostic reagents used in the
MemberState;
— istoperiodicallyarrangecomparativetests;
— istoholdisolatesoftheagentsofthediseaseinquestion,orcorre-
sponding tissues containing such agents, coming from cases
confirmedintheMemberState;
— is to ensure confirmation of results obtained in diagnostic labora-
toriesdesignatedbytheMemberState;
(d) istocooperatewiththeCommunityreferencelaboratory.
2. However,bywayofderogationfrompoint1,MemberStateswhichdonot
haveanationalreferencelaboratoryaretousetheservicesoftheCommu-
nity reference laboratory or of national reference laboratories in other
MemberStates.
3. Thenationalreferencelaboratoriesare:
Austria: BundesanstaltfürTierseuchenbekämpfung,
Mödling
RobertKochGasse17
A-2340Mödling
Belgium: CERVA-CODA-VAR
Centred'ÉtudeetdeRecherchesVétérinaireset
Agrochimiques
CentrumvoorOnderzoekinDiergeneeskunde
enAgrochemie
VeterinaryandAgrochemicalResearchCentre
Groeselenberg99
B-1180Bruxelles
Denmark: DanishVeterinaryLaboratory
Bülowsvej27
DK-1790CopenhagenV
Finland: Eläinlääkintä-jaelintarvikelaitos
Hämeentie57
FIN-00550Helsinki
France: AgenceFrançaisedeSécuritéSanitairedes
Aliments
Laboratoiredepathologiebovine
31,avenueTonyGarnier
BP7033
F-69342LyonCedex
Germany: BundesforschungsanstaltfürViruskrankheiten
derTiere
AnstaltsteilInselRiems
Boddenblick5A
D-17498InselRiems2001R0999—EN—01.01.2002—003.001—44
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Greece: LaboratoryofMicrobiologyandInfectious
Diseases
FacultyofVeterinaryMedicine
AristotelianUniversityofThessaloniki
UniversityCampus
GR-54006Thessaloniki
(rapidandimmunologicaltests)
LaboratoryofGrossPathology(Morgue
FacultyofVeterinaryMedicine
AristotelianUniversityofThessaloniki
Giannitson&VoutyraSt
GR-54627Thessaloniki
(histopathology)
Ireland: CentralVeterinaryResearchLaboratory
Abbotstown
Castleknock
Dublin15
Ireland
Italy: IstitutoZooprofilatticoSperimentaledel
Piemonte
LiguriaeValled'Aosta
CEA
ViaBologna
I-148-10150Torino
Luxembourg: CERVA-CODA-VAR
Centred'ÉtudeetdeRecherchesVétérinaireset
Agrochimiques
CentrumvoorOnderzoekinDiergeneeskunde
enAgrochemie
VeterinaryandAgrochemicalResearchCentre
Groeselenberg99
B-1180Bruxelles
Netherlands: InstituutvoorDierhouderijenDiergezondheid,
ID-DLOLelystad
Edelhertweg15
Postbus658200ABLelystad
Netherlands
Portugal: LaboratórioNacionaldeInvestigaçãoVeter-
inária
EstradadeBenfica,701
P-1500Lisboa
Spain: LaboratoriodelaFacultaddeVeterinaria
DepartamentodePatologíaAnimal(Anatomía
Patológica)
Zaragoza
Spain
(BSEandscrapie,methodsotherthanrapid
tests)
LaboratorioCentraldeVeterinariadeAlgete
Madrid
Spain
(rapidtests)
CentrodeInvestigacionenSanidadAnímal
(CISA)
Crta,DeAlgetealCasardeTalamanca
28130Valdeolmos(Madrid)
Spain
(TSEsotherthanBSEorscrapie)
Sweden: NationalVeterinaryInstitute
S-75189Uppsala
UnitedKingdomVeterinaryLaboratoriesAgency
WoodhamLane
NewHaw
Addlestone
SurreyKT153NB
UnitedKingdom2001R0999—EN—01.01.2002—003.001—45
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CHAPTERB
Communityreference laboratory
1. TheCommunityreferencelaboratoryforTSEsis:
TheVeterinaryLaboratoriesAgency
WoodhamLane
NewHaw
AddlestoneSurreyKT153NB
UnitedKingdom
2. ThefunctionsanddutiesoftheCommunityreferencelaboratoryare:
(a) to coordinate, in consultation with the Commission, the methods
employedintheMemberStatesfordiagnosingBSE,specificallyby:
— storing and supplying corresponding tissues containing the agent,
for the development or production of the relevant diagnostic tests
orfortypingstrainsoftheagent;
— supplyingstandardseraandotherreferencereagentstothenational
reference laboratories inordertostandardisethetestsandreagents
usedintheMemberStates;
— building up and retaining a collection of corresponding tissues
containingtheagentsandstrainsofTSEs;
— organising periodic comparative tests of diagnostic procedures at
Communitylevel;
— collecting and collating data and information on the methods of
diagnosis used and the results of tests carried out in the Commu-
nity;
— characterising isolates of the TSE agent by the most up-to-date
methodstoallowgreaterunderstandingoftheepidemiologyofthe
disease;
— keepingabreastoftrendsinsurveillance,epidemiologyandpreven-
tionofTSEsthroughouttheworld;
— maintaining expertise onpriondiseases toenable rapid differential
diagnosis;
— acquiringathoroughknowledgeofthepreparationanduseofdiag-
nosticmethodsusedtocontrolanderadicateTSEs;
(b) to assist actively in the diagnosis of outbreaks of TSEs in Member
StatesbystudyingsamplesfromTSE-infected animalssentforconfir-
matorydiagnosis,characterisationandepidemiologicalstudies;
(c) tofacilitatethetrainingorretrainingofexpertsinlaboratorydiagnosis
with a view to the harmonisation of diagnostic techniques throughout
theCommunity.
CHAPTERC
Samplingandlaboratorytesting
1. Sampling
Any samples intended to be examined for the presence of a TSE shall be
collectedusingthemethodsandprotocolslaiddowninthelatesteditionof
theManual of standards for diagnostic tests and vaccines of the Interna-
tional Office for Epizooties (IOE/OIE) (hereinafter referred to as ‘the
Manual’).Intheabsenceofsuchmethodsandprotocols,thesamplesshall
be collected in a manner appropriate for the correct application of tests.
The samples shall be correctly marked as to the identity of the sampled
animal.
2. Laboratories
Any laboratory examination for TSE shall be carried out in laboratories
approvedforthatpurpose.
3. Methods and protocols
3.1.Laboratory testing for the presence of BSE in bovine animals
(a) Suspectcases
Tissuesfrombovineanimalssentforlaboratorytestingpursuanttothe
provisionsofArticle12(2)shallbesubjecttoahistopathologicalexam-
ination as laid downin thelatest edition of theManual, except where2001R0999—EN—01.01.2002—003.001—46
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the material is autolysed. Where the result of the histopathological
examination isinconclusive ornegative orwherethe material isauto-
lysed, the tissues shall be subjected to an examination by one of the
otherdiagnostic methodslaiddownintheManual(immunocytochem-
istry, immuno-blotting or demonstration of characteristic fibrils by
electron microscopy). However, rapid tests cannot be used for this
purpose.
If the result of one of the above examinations is positive, the animals
shallberegardedapositiveBSEcase.
(b) BSEmonitoring
Tissuesfrombovineanimalssentforlaboratorytestingpursuanttothe
provisions of Annex III, Chapter A, Section I (Monitoring in bovine
animals)shallbeexaminedbyarapidtest.
Whentheresultoftherapidtestisinconclusiveorpositive,thetissues
shall immediately be subject to confirmatory examinations in an offi-
cial laboratory. The confirmatory examination shall start by a
histopathological examination of the brainstem as laid down in the
latesteditionoftheManual,exceptwherethematerial isautolysedor
otherwise not suitable for examination by histopathology. Where the
result of the histopathological examination is inconclusive or negative
orwherethematerial isautolysed,thetissuesshallbesubjectedtoan
examination by one of the other diagnostic methods mentioned under
(a).
An animal shall be regarded a positive BSE case if the result of the
rapidtestispositiveorinconclusive,and
— the result of the subsequent histopathological examination is posi-
tive,or
— theresultofanotherdiagnosticmethodmentionedunder(a)isposi-
tive.
3.2.Laboratory testing for the presence of scrapie in ovine and caprine animals
(a) Suspectcases
Tissues fromovine and caprine anim als sent for laboratory testing
pursuant to the provisionsof Article 12(2) shall be subject to a histo-
pathological examination as laid down in the latest edition of the
Manual, except where the material is autolysed. Where the result of
thehistopathological examination isinconclusiveornegativeorwhere
thematerial isautolysed,thetissuesshallbesubjectedtoanexamina-
tionbyimmunocytochemistry orimmuno-blotting,aslaiddowninthe
Manual.However,rapidtestscannotbeusedforthispurpose.
If the result of one of the above examinations is positive, the animal
shallberegardedapositivescrapiecase.
(b) Scrapiemonitoring
Tissues fromovine and caprine anim als sent for laboratory testing
pursuant to the provisionsof Annex III, Chapter A, Section II (Moni-
toringinovineandcaprineanimals)shallbeexaminedbyarapidtest.
Whentheresultoftherapidtestisinconclusiveorpositive,thebrain-
stem shall immediately be sent to an official laboratory for
confirmatory examinations by immunocytochemistry or immuno-blot-
ting,asreferredtounder(a).
Ananimalshallberegardedapositivescrapiecaseiftheresultofthe
confirmatoryexaminationispositive.
3.3.Laboratory testing for the presence of TSEs other than those referred to in
points 3.1 and 3.2
ThetestscarriedouttoconfirmthesuspectedpresenceofaTSEdifferent
fromthose referred to in points 3.1 and 3.2 shall include at least a histo-
pathological examination of brain tissue. The competent authority may
also require laboratory tests such as immunocytochemistry, immuno-blot-
ting, demonstration of characteristic fibrils by electron microscopy orother methods designed to detect the disease associated form of the prion
protein. In any case at least one other laboratory examination shall be
carriedoutiftheinitialhistopathologicalexaminationisnegativeorincon-
clusive. At least three different examinations shall be carried out in the
eventofthefirstappearanceofthedisease.
In particular, where BSE is suspected in a species other than bovine
animals,samplesshallbesubmittedforstrain-typing,wherepossible.2001R0999—EN—01.01.2002—003.001—47
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4. Rapid tests
For the purposes of carrying out the tests in accordance with Article 5(3)
andArticle6(1),thefollowingmethodsshallbeusedasrapidtestswithin
themeaningofthisRegulation:
— immuno-blotting test based on a western blotting procedure for the
detectionoftheprotease-resistantfragmentPrPRes(PrionicsChecktest),
— chemiluminescentELISAtestinvolvinganextractionprocedureandan
ELISA technique, using an enhanced chemiluminescent reagent (Enfer
test),
— sandwich immunoassay for PrPRescarried out following denaturation
andconcentrationsteps(Bio-RadPlateliatest).
5. Alternative tests
(Tobedefined)2001R0999—EN—01.01.2002—003.001—48
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ANNEX XI
A.Concerningtheremovalofspecifiedriskmaterial
1. MemberStatesshallensurethatthespecifiedriskmaterialdesignatedbelow
isremovedanddestroyedinaccordancewithpoints7to11.
(a) Thefollowingtissuesaredesignatedasspecifiedriskmaterial:
(i) the skull including the brain and eyes, the tonsils, the vertebral
column excluding the vertebrae of the tail and the transverse
processesofthelumbarvertebrae,butincludingdorsalrootganglia
and spinal cord of bovine animals aged over 12 months, and the
intestines fromthe duodenumto the rectumof bovine anim als of
allages;
(ii) the skull including the brain and eyes, the tonsils and the spinal
cord of ovine and caprine animals aged over 12 months or which
have a permanent incisor erupted through the gum, and the spleen
ofovineandcaprineanimalsofallages.
Adecisionmaybetakeninaccordancewiththeprocedurereferredtoin
Article24(2)inparticularwithaviewtoadjusttheagefortheremoval
of bovinevertebral column, inthe light of thestatistical probability of
the occurrence of BSE in the relevant age groups of the Community's
bovine population, basedon the resultsof BSEmonitoring, withparti-
cular reference to testing of bovine animals, as established by Annex
III.
(b) In addition to the specified risk material listed in (a), the following
tissues must be designated as specified risk material in the United
Kingdomof Great Britain and Northern Ireland and in Portugal, with
theexceptionoftheAutonomousRegionoftheAzores:
— the entire head excluding the tongue, including the brain, eyes,
trigeminalgangliaandtonsils;thethymus,thespleenandthespinal
cordofbovineanimalsagedoversixmonths.
2. Specified risk material or processed material derived from it may be
despatched only with a view to subsequent incineration, in accordance
withpoint11or,whereappropriate,point7(b).
3. MemberStatesshallensurethatbonesofbovine,ovineandcaprineanimals
arenotusedfortheproductionofmechanicallyrecoveredmeat.
4. MemberStatesshallensurethatlacerationafterstunningofcentralnervous
tissueby means of an elongated rod-shaped instrument introduced into the
cranial cavity is not effected within their territory with regard to bovine,
ovine or caprine animals whose meat is intended for human or animal
consumption.
5. The specified risk material referred to in point 1(a) shall not be imported
intotheCommunityafter31March2001.
Theproductsofanimaloriginlistedbelowshallbesubjecttorestrictionson
importintotheCommunity:
— freshmeat:themeatdefinedbyDirective64/433/EEC,
— mincedmeatandmeatpreparations:themincedmeatandmeatprepara-
tionsdefinedbyDirective94/65/EC(1);
— meatproducts:themeatproductsdefinedbyDirective77/99/EEC(2),
— other products of animal origin: other products of animal origin as
definedbyDirective77/99/EEC,
— renderedfatsasreferredtobyDirective92/118/EEC,
— gelatinasreferredtobyDirective92/118/EEC,
— petfoodasreferredtobyDirective92/118/EEC,— theprocessedanimalproteinreferredtoinDirective92/118/EEC,— bonesandboneproductsasreferredtobyDirective92/118/EEC,
— raw material for the manufacture of animal feedingstuffs as referred to
byDirective92/118/EEC,
— bovine intestines as referred to in Article 2(b)(v) of Directive 77/99/
EEC.2001R0999—EN—01.01.2002—003.001—49
(1) CouncilDirective94/65/ECof14December1994layingdowntherequirementsforthe
productionandplacingonthemarketofmincedmeatandmeatpreparations(OJL368,31.12.1994,p.10).
(
2) CouncilDirective77/99/EECof21December1976onhealthproblemsaffectingintra-
Community trade in meat products (OJ L 26, 31.1.1977, p. 85). Directive as last
amendedbyCouncilDirective97/76/EC(OJL10,16.1.1998,p.25).
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(a) When the abovementioned products of animal origin, containing mate-
rial from bovine, ovine or caprine animals are imported into the
Community from third countries or regions thereof, the health certifi-
cates shall be accompanied by a declaration signed by the competent
authorityofthecountryofproduction,wordedasfollows:
‘Theproductofanimalorigindoesnotcontain,andisnotderivedfrom
any product referred to in Chapter F of Annex IX to Regulation (EC)
No 999/2001 of 22 May 2001 laying down rules for the prevention,
control and eradication of certain transmissible spongiform encephalo-
pathies,norfromspecifiedriskmaterial asdefinedinAnnexVtothat
Regulation, produced after 31 March 2001, or mechanically recovered
meat obtained from bones of the head or vertebral column of bovine,
ovine or caprine animals, produced after 31 March 2001. After 31
March 2001 the animals have not been slaughtered after stunning by
means of gas injected into the cranial cavity or killed by the same
method or slaughtered by laceration after stunning of central nervous
tissueby means ofan elongated rod-shaped instrument introduced into
thecranialcavity.’
(b) Any reference to ‘products of animal origin’ designates products of
animal origin listed in this point and does not concern other products
of animal origin containing or derived from those products of animal
origin.
6. Point5shallnotapplytoimportsfrom:
Australia
ArgentinaBotswanaBrazilChileCostaRicaNamibiaNewZealandNicaraguaParaguayUruguaySingapore
Swaziland.
7. Member States shall carry out frequent official inspections to verify the
correctapplication ofthisSectionandshallensurethatmeasuresaretaken
to avoid any contamination, particularly in slaughterhouses, cutting plants,animal waste processing plants, high-risk processing plants or premises
approved by the Member States in accordance with Article 7 of Directive
90/667/EEC,pointsofsaletotheconsumer,landfillsitesandotherfacilities
forstorageorincineration.MemberStatesshallinparticularsetupasystem
toensureandcheckthat:
(a) specifiedriskmaterialusedintheproductionofproductsreferredtoin
Article1(2)areusedsolelyforauthorisedpurposes;
(b) specified risk material, especially where the removal takes place at
establishments or premises other than slaughterhouses, is completely
separated fromother waste not intended for incineration, is collected
separately and is disposed of in accordance with point 1 and points 8
to 11. Member States may decide to allow dispatch of heads or
carcasses containing specified risk material to another Member State
after that other Member State has agreed to receive the material and
hasapprovedthespecificconditionsapplicabletosuchtransport.
However, carcasses, half carcasses and quarter carcasses containing no
specified risk material other than vertebral column, including dorsal root
ganglia, may be imported into a Member State, or dispatched to another
MemberStatewithoutthelatter'sprioragreement.
8. MemberStatesshallensurethatspecifiedriskmaterialisremovedat:
(a) slaughterhouses;
(b) cutting plants, high-risk processing plants or premises referred to in
Articles 3 and 7 of Directive 90/667/EEC, under the supervision of a
designatedagentappointedbythecompetentauthority.Thoseestablish-
mentsshallbeapprovedforthatpurposebythecompetentauthority.2001R0999—EN—01.01.2002—003.001—50
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However, Member States may provide for the vertebral column to be
removedatpointsofsaletotheconsumer.
Wherespecifiedriskmaterialisnotremovedfromdeadanimalswhichhave
not been slaughtered for human consumption, the parts of the body
containing specified risk material or the entire body must be treated as
specifiedriskmaterial.
9. MemberStatesshallensurethatallspecifiedriskmaterialisstainedwitha
dye and, as appropriate, marked immediately on removal, and completely
destroyed:
(a) byincinerationwithoutpre-processing;or,
(b) provided that the dye or marking remains detectable, after pre-proces-
sing:
(i) in accordance with the systems described in Chapters I to IV, VI
andVIIoftheAnnextoDecision92/562/EEC:
— byincineration,
— byco-incineration;
(ii) inaccordanceatleastwiththestandardssetoutinAnnexItoDeci-
sion1999/534/EC,byburialinanapprovedlandfillsite.
10. MemberStatesmayderogatefromtheprovisionsofpoints8and9toallow
theincinerationorburialofspecifiedriskmaterialorentirebodies,without
priorstaining,or,asappropriate,withoutremovalofthespecifiedriskmate-
rial, in the circumstances set out in Article 3(2) of Directive 90/667/EEC
and by a method which precludes all risk of transmission of a TSE and is
approved and verified by the competent authority, in particular where
animals have died or have been killed in the context of disease control
measures.
11. Member States may despatch specified risk material or the material
processed therefromto other Mem ber States for incineration under the
conditions laid downin Article 4(2)of Decision 97/735/EC, whereapplic-
able.
Thispointmay beamended attherequest ofaMemberState toallowthe
despatch of specified risk material or the material processed therefrom to
third countries for incineration, conditions governing such export having
beenadopted.
12. Bywayofderogationfrompoint1(a)(i),adecisionmaybetakeninaccor-
dance with the procedure referred to in Article 24(2) to allow the use of
vertebralcolumnanddorsalrootgangliafrombovineanimals:
(a) born,continuouslyrearedandslaughteredinMemberStatesforwhicha
scientific evaluation established that the occurrence of BSE in native
bovineanimalsishighlyunlikely,orunlikelybutnotexcluded;or
(b) born after the date of effective enforcement of the prohibition on the
feeding of mammalian protein to ruminants in Member States with
reported BSE in native animals or for which a scientific evaluation
established that the occurrence of BSE in native bovine animals is
likely.
The United Kingdom, Portugal, Finland, Sweden and Austria may benefit
fromthis derogation on the basis of previously subm itted and evaluated
evidence.OtherMemberStatesmayapplyforthisderogationbysubmitting
conclusive supporting evidence to the Commission regarding point (a) or
(b),asappropriate.
Member States benefiting from this derogation shall, in addition to the
requirementslaiddowninAnnexIII,ChapterA,sectionI,ensurethatone
oftheapprovedrapidtestslistedinAnnexX,ChapterC,point4,isapplied
toallbovineanimalsover30monthsofagewhich:
(a) havediedonthefarmorintransport,butwhichhavenotbeenslaugh-
teredforhumanconsumption,withtheexceptionofthosedeadanimals
in remote areas with a low animal density situated in Member States
wheretheoccurrenceofBSEisunlikely;
(b) weresubjecttonormalslaughterforhumanconsumption.
This derogation shall not be granted to allow the use of vertebral column
and dorsal root ganglia from bovine animals aged over 30 months from
the United Kingdomor fromPortugal with the exception of the Autono-
mousRegionoftheAzores.
Experts from the Commission may carry out on-the-spot checks to further
verifythesubmittedevidenceinaccordancewithArticle21.2001R0999—EN—01.01.2002—003.001—51
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B.Concerningstatisticalsurveys
1. ThestatisticalsurveyreferredtoinArticle22mustcover:
— theanimalssampledpursuanttotheprovisionsofAnnexIII,ChapterA,
SectionI,points2.1and4.1,
— alltheanimalsinthesubpopulationreferredtoinAnnexIII,ChapterA,
SectionI,point3,insteadofarandomsample.
Thisprovision,applicable for aperiod of one year,may be reviewed inthe
lightofexperiencegainedinthefirstsixmonths.
2. Austria,FinlandandSwedenmaydecidetoderogatefromtheprovisionsof
point1,secondindent,inremoteareaswithalowanimaldensity.
C.Concerningprohibitionsonanimalfeeding
Council Decision 2000/766/EC concerning certain protection measures with
regard to transmissible spongiform encephalopathies and the feeding of animal
protein, and Commission Decision 2001/9/EC concerning control measures
required for the implementation of Council Decision 2000/766/EC, remain in
force.
AdecisionmaybetakeninaccordancewiththeprocedurereferredtoinArticle
24(2)to adapt Decision 2000/766/EC tothe situation ofeach Member State in
the light of the results of Commission inspections and the incidence of BSE,
based on the results of BSE monitoring, with particular reference to testing of
bovineanimals,asestablishedbyAnnexIII.
D.Concerningplacingonthemarketandexport
1. Thefollowingprovisionsremaininforceastransitionalmeasures:
Commission Decision 92/290/EEC of 14 May 1992 concerning certain
protection measuresrelating tobovineembryosinrespectofbovinespongi-
formencephalopathy(BSE)intheUnitedKingdom.
Council Decision 98/256/EC of 16 March 1998 concerning emergency
measures to protect against bovine spongiform encephalopathy, amending
Decision94/474/ECandrepealingDecision96/239/EC.
CommissionDecision98/351/ECof29May1998settingthedateonwhich
dispatchfromNorthernIrelandofbovineproductsundertheExportCertified
HerdsSchememaycommencebyvirtueofArticle6(5)ofCouncilDecision
98/256/EC.
Commission Decision 1999/514/EC of 23 July 1999 setting the date on
which dispatch fromthe United Kingdomof bovine products under the
date-based export scheme may commence by virtue of Article 6(5) of
CouncilDecision98/256/EC.
Commission Decision 2000/345/EC of 22 May 2000 setting the date on
whichdispatchfromPortugaltoGermanyofcertainproductsforthepurpose
ofincinerationmaycommencebyvirtueofArticle3(6)ofDecision98/653/
EC.
CommissionDecision2000/371/ECof6June2000settingthedateonwhich
dispatch offighting bullsfromPortugaltoFrance maycommence byvirtue
ofArticle3(7)ofDecision98/653/EC.
CommissionDecision2000/372/ECof6June2000settingthedateonwhich
dispatchoffightingbullsfromPortugaltoSpainmaycommencebyvirtueof
Article3(7)ofDecision98/653/EC.
Commission Decision 2001/376/EC of 18 April 2001 concerning measures
made necessary by the occurrence of bovine spongiform encephalopathy in
Portugalandimplementingadate-basedexportscheme.
2. Importsofbovineanimalsaretobesubjecttothepresentationofaninterna-
tionalanimalhealthcertificateattestingthat:
(a) the feeding of ruminants with proteins derived from mammals hasbeen
bannedandthebanhasbeeneffectivelyenforced;
(b) the bovine animals intended for export to the Community are identified
byapermanentidentification systemenablingthemtobetracedbackto
the damand herd of origin and are not the progeny of BSE suspected
females.
3. Importsofbovineembryosandovaaretobesubjecttothepresentationofan
international animal health certificate attesting that the feeding ofruminants
withproteinsderivedfrommammalshasbeenbannedandthebanhasbeen
effectivelyenforced.2001R0999—EN—01.01.2002—003.001—52
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4. Points2and3shallnotapplytoimportsfrom:
Australia
Argentina
BotswanaBrazilChile
CostaRica
NamibiaNewZealand
Nicaragua
ParaguayUruguaySingapore
Swaziland.2001R0999—EN—01.01.2002—003.001—53