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DOCUMENTS "COM"
COM(77)287
Vol.1977/0099

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(77)287final.
\
Brussels.23June1977
\
Proposalfora
COUNCILDIRECTIVE
amendingDirective64/432/EECon,asregardsbrucellosis,
the"buffered "brucellaantigentest,45/20vaccineandthe
inconclusive rangetotheserumagglutination test
^ ■■■■
, :)
,(submittedtotheCouncilbytheCommission)
/
•\
C04(77)287final

Explanatory Note
0
SinoetheCouncilDirective64/432/EECwasadopted,progressinthe
fieldofcontrolofbovine "brucellosis hasbeenachievedinmanya.reas,
bothinthefieldofprophylaxis andindiagnosis.MemberStateshave
consequently introducedmodernisedmethodsintheirnationalbrucellosis
controlprogrammes.Thismeansthatthereisnowadiscrepancy between
themethodsusedinrelationtointra-Community trade,ascomparedwith
thecontrolofnationalherds.
»
AsCommunityprovisionsaimatfullharmonisation ofcontrolprocedures,
itisintendedtodeletethesediscrepancies bytheintroduction ofthe
diagnosticprocedures(bufferedbrucellaantigentest),thenewvaccine
(45/20)andanimprovedevaluationprocedurefortheserumagglutination
test.

COUNCILDIRECTIVE
of
amending Directive64/432/EECon,as
regardsbrucellosis ,thebufferedbrucella
antigentest,45/20vaccineandthe
inconclusive rangetotheserumagglutination
test
THECOUNCILOPTHEEUROPEANCOMMUNITIES,
HavingregardtotheTreatyestablishing theEuropeanEconomicCommunity
andinparticularArticles43and100thereof,
HavingregardtotheproposalfromtheCommission, ,
HavingregardtotheOpinionoftheEuropeanParliament,
HavingregardtotheOpinionoftheEconomicandSocialCommittee,
WhereasCouncilDirective64/432/feBCof26June1964onanimalhealthproblems
affectingintra-Community tradeinbovineanimalsandswine^,aslastamended
byDirective77/98/EECjf21Dtjember1976,1.3ysdowncommonstandardson
anti-brucellosis measuresapplicableto.-animals-.intendedforintra-Community
trade: •
» «
Whereasequivalentmeasuresforthediagnosisandcontrolofbovinebrucellosis
are,byw&yofderogation,'stillapplicableinthenewMemberStates;whereas
inordertoassurethecontinuousfreetradtwithintheCommunityofbovines
andswine,itisnecessarytoadaptthetechnicalprovisionsoftheabove
Directiverelatingtobrucellosistotakeaccountofthissituation;
Whereas,duetonewscientificknowledgeandtechnicaldevelopments .inthe.
diagnosisandcontrolofbovinebrucellosis ,anadjustmentofexistingCommunity
measuresinthisfieldhasprovednecessary,.
HASADOPTEDTHISDIRECTIVE:
OJNo121o-f25.7.1964P.1977/64
OJL26of21.1.1977P.8!

.Article 1
InAnnex A.Chapter IIunder A1,ofDirective 64/432/EEXJ
_in(c).thefollowing newsubheading (iii)shall "beincluded :
<A
"(iii)Hovevor ,ariofficially ^rucellosis-free herd need notnecesBPrily lose -
itsstatus ,ifitcontains animal 3with less thai ^60International Units
totheserum agglutination test ,providing that thetitre ofthese animals
does notexceed 10EECunits intwocomplement fixation tests ,carried
outatintervals ofatleast sixty days *These animals Bust notbeused
inintra -Community trade .
.Article 2
InAnnex A.II.A.1.(c)(i )thefollov /ing shall beinserted attheendj
"atthediscretion oftheMember Stite involved ,either ofthetwoofficii 1
sero-cgglutinttion test3 ,mentioned inthefirst indent ofthis ps.rigrcph f
m*ybereplaced byabuffered brucella antigen test complying v.'ith Annex
C,D;thetime interval between thetwoofficial tests must bertleast
three months aid atmost 12months' *.
Article 3
InAnnex n,At1(cnii )thefollowing ^shall replace theexisting text :
(ii)arechecked annually toestablish that brucellosis isriotpresent bythree
ring-tests carried outat -intervals ofatleast three months ortworing-
tests c.tijninterV&l 'o'f.&tleast thrfee months andoneserological test
(serum agglutination t«3t orbuffered brucella antigen test )c?.rried out
notless than sixweeks softer thesecond ring-testi •Ifring tests are
notcarried out,twoserological te3ts (serum t^glutination test or
buffered brucella Rntigern teat )shall becarried outeech year strn
interval ofajjleast thr^e months andnotmore then sixmonths .
'ilhere ,inatimber State ?:.llofv/hose bovine herdty aresubject tooffioirl
operations tocoribat brucellosis ,thepercentage ofbovine herds infected
isnotmore than i%9itvill bQsufficient toccriy outeach ye*r two
ring-testa ataninterval ofatleast three months ,oroneserologics .!
test (eaagijlutin&'tiontest ,oronebuffered brucella mtigen testy .

'* . • Artici® A .
InAnnex A.XI.A.2(b).between "thewords "vaccine "and "or"the :
following shall beinserted :
•»"orWithkilled 45/20adjuvant added vaccine used ®.o©®'jpdia ^ ■io&
method officially .approved intheMember Stata ." ~
Article 5
InAnnex A.IT.A.2(c )inthesecond line between thewords wsmimel® w
tnd "which ",thefollowing shall beinserted ; -.
"which have been vaccinate ^with live Buck 19vaccine sndwe
Annex A,II,A,2(^2^8econd -paraffruph .inthefirst ,line ,between thewords
"vaccinated *end"and **thefollowing shell b®inserted s '-
"with live Buck 19vaccine' *.
•Article 7
*InAnnex Cthefollowing shall beadded :
"D.Thebuffered brucella antigen teat .
Thebuffered brucella antigen test ®aybeoarriad outuslag .on®oftiis
following methods I .
(â)Manual test
1,Thestandard serum ahall bethesecond International Standard Anti–
brucella abortus serum which issupplied bytheCentral Veterinary
Laboratory ,Waybridge ,Surrey ,Engl and »
".2.Th«antigen will beprepared without reference totheo$lX
concentration but itssensitivity must bestandardise !inrelation
tothesecond international i-nti-brucelle r-.bortus et»nd«,rd serum ,in
such awaythat theantigen produces apositive reaction with ?
serum dilution of 1*47.5 &nd ®negative reect ionwith *.dilution of
■'1,55''ί "■"" τ' '
3.Theantigen shc.ll besuspended inbuffered brucella antii^en diluent
•atapHof3.65 -0.05 £Jidmty hr.ve been stained bytheuseofRose
Bengal dye .Thecntigejn U3ed maybemtjnufactured according tothe
instructions given inAnnex Atotheworking paper of20February
1974 (Doc.No503/VI/74).
*.
4.Weybridge Strein No99orUSDA1119 oranyother strrin ofequivalent
sensitivity must beuaed forpreparing theantigen .
5.Theculture media ,used forkeeping the strc.in inthe 1-bor-*.tory -nd
forproducing the antigen must besuch thr.t they donot encour -ge
bacterial dissociation (3minus R);potato agM *medium orcontinuous
'culture methods should beused .

-4-
, V
6.The tintigeneh*ll J>etested hg&inst 8freeze-4ried known positive
.andnegative e^rt . ■... * - .
7„.®iesupervision andofficial control ofstand ,priserum tndantigen %
shall bectrried ovitbytheofficial institutes listed in
Annex C,A,9oP«this Directive .
8.Thetntigenshall bedelivered reedy foruse.
9.Ihebuffered brucella antigen test must becarried outinthe
*
•following manner :
(a)Place onedrop (0.03 ml)ofantigen alongside onedrop (0.03 ml)
ofthe sérum onawhite plt.te .
:(b)Mixwith anapplicator stick ,first inastraight line tudthen •'
''inacircle ofabout 10-12 mmdi-jneter.' ■
(c)Hieplate will then berocked with abackwards andforwards motion
forfour minutes (about thirty perminute ). " •
(d.)Ihetest must beread inagood light ;noevidence ofagglutination
•will beregarded asnegative ;enydegree ofegglutin ?tion will
*'■be'regarded &spositive ,unless there wasobvious evidence ofexcess -•
....ivedrying round theedges .
Under theprovisions outlined inArticle 12,theprocedures for
carrying outtheinterpretp.tion ofthebuffered brucella tntigen
test mayber-.utomated.' *
.(B)Automated test '
Themethod must beoapable ofprodttoing aresult which isatleast as
sensitive and accurate asthe .manual method .
Article 8
EaeMember States shall bring into lorce thelaws ,regulations and
administrative provisions necessary tocomply with this Directive on
1January 1978andshall forthwith inform theCommission thereof .
Article 9
This Directive isaddressed totheMember States .
•■ .
' ••
Done atBrussels ' 'FortheCounoil
„ThePresident