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COM(79)509
Vol.1979/0173

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(79)509final.
Brussels.2October1979
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v ■■.<•\>JProposai'rfôr^A^
COUNCILDIRECTIVE
amendingDirective 64/432/EECasregards
tuberculosis andbrucellosis
(submittedtotheCouncilbytheCommission )
C0M(79)509final.

EXPLANATORY NOTE
Byvirtue ofArticle 104oftheTreaty ofAccession ,Denmark ,Ireland and
theUnited Kingdom were authorized tomaintain foraninterim period ,until
theendof1977 ,their national rules fordeclaring aherd ofcattle
officially free oftuberculosis orfree ofbrucellosis ,these derogations
were subsequently prolonged until theend of1979 .
Onthesame basis certain derogations from existing Community provisions
were granted ,toallow forthemaintenance oftraditional exports ofcattle
from Ireland andtheUnited Kingdom .
Thelimiting factors tothedismantling ofthese derogations were technical
problems involving primarily tuberculins andcastrates ;these technical
problems have nowbeen solved thus allowing forharmonization totake
place .
Theattached proposals allow for areduction intheamount ofroutine
tuberculosis testing inthose regions oftheCommunity where thedisease
hasvirtually disappeared ,thus reducing the cost andeasing trade in
bovine animals .
Derogations concerning bovine animals intended formeat production and
which areunder 30months ofagethat were allowed for intheoriginal
Council Directive (64/432/EECArt .7.I.C ),areprolonged for afurther two
years ,that isuntil thecompletion oftheCommunity accelerated anti-
brucellosis campaign .
Itisadditionally proposed tosuppress therequirement totest forbru­
cellosis animals intended formeat production andwhich areunder 30days
ofagebecause thetest below this age isinsufficiently precise .

f?epeeal f©p g
CounciL Directive
amending Directive 64/432/EECasregards tuberculosis andbrucellosis
THE COUNCIL OFTHE EUROPEAN COMMUNITIES ,
Having regard totheTreaty establishing theEuropean Economic Community ,and in
particular Articles 43and100thereof ;
Having regard totheproposal from theCommission ;
Having regard totheopinion oftheEuropean Parliament ;
Having regard totheopinion oftheEconomic andSocial Committee ;
Whereas bovine tuberculosis hasvirtually disappeared from certain regions ofthe
Community andwhereas itisnecessary toreduce the cost ofroutine testing for
tuberculosis inthose regions ;
Whereas ,inorder toreduce thetime taken toreestablish the status of"officially
tuberculosi s-free"asregards those herds inwhich tuberculosis hasbeen found ,
thenecessary methods ofcontrol must beadopted ;
Whereas under Article 104 (3)oftheAct ofAccession ,Denmark ,Ireland and the
United Kingdom were authorized toretain ,until 31December 1977 ,their national
provisions fordeclaring aherd ofcattle officially free oftuberculosis orfree
ofbrucellosis ;whereas these authorizations wereextended onthree occasions ^^
inthecase oftuberculosis or,inthecase ofIreland andtheUnited Kingdom ,on
twooccasions ^^^relating tobrucellosis freedom within themeaning ofArticle 2
ofCouncil Directive 64/432/EEC ,aslast amended by
Whereas these derogations were instituted andextended ,inview ofthetime
required toprovide solutions tobasic technical problems ;
Whereas ,forthesame reason and inorder not tointerrupt thetraditional trade in :
live animals between Ireland andtheUnited Kingdom ,itwasnecessary toprolong
forthesame period certain special derogations granted inrespect ofsuch trade ;
Whereas these basic technical problems have nowbeen solved ,thus allowing for
certain technical amendments toDirective 64/432/EEC inorder that the
abovementioned derogation will nolonger benecessary ;
Whereas ,inorder tofacilitate certain trade inbovine animals and until such time
astheCommunity accelerated disease programme iscompleted ,itisnecessary to
amend and toprolong certain derogations relating tobrucellosis which were
provided forinDirective 64/432/EECArticle 7<1)(C >;
HAS ADOPTED THIS DIRECTIVE :
(1)0JNoL15,19.01.1978 ,p.32 (3)OJNoL158,26.06.1979 ,p.17
(2)0JNoL29,03.02.1979 ,p.27 (4)0JNo121,29.7.1964 ,p.1977 /64
(5)0JNo

-a-
Article 1
Directive 64/432/EEC ishereby amended asfollows :
1.The following paragraph shall beadded toArticle 3:
"14. Bywayofderogation from Annex A(l)(b )itmaybedecided ,under the
procedure laid down inArticle 12,that inaMember State orregion
thereof where atleast 99.8% ofthebovine herds have been declared
officially tuberculosis free within themeaning ofArticle 2(d)for
atleast 10years ,andwhere foratleast 6years bovine tuberculosis
hasnotbeen recorded onanannual basis inmore that 1herd per
10000herds inthat Member State orregion ,itbeing understood that
allbovine animals reacting toatuberculin test andallbovine animals
slaughtered within that Member State orregion must have been submitted
toapost mortem examination byanofficial veterinarian and ifnecessary
abacteriological examination ,theinspections fordetermining whether
this status istobepreserved maybecarried out inamanner and in
regions tobedecided under the same procedure .
Ifone oftheconditions provided forinthefirst subparagraph
ceases tobefulfilled ,theCommission -after assessing thecircum­
stances ofthe recrudescence oftuberculosis -shall adopt ,under
the same procedure ,.adecision torescind thederogation decision
taken inrespect ofthat Member State orregion ofaMember State ."

-3-
2.(a)InArticle7(1)(C)inthesecondsentence,thewords"ifover30days
ofage"shallbeinsertedbetweenthewords"animals"and"must".
(b)InArticle7(1)CC),inthesecondparagraphthedate"31December1979"
shallbereplacedby"31December1982".
3.ThefollowingparagraphshallbeaddedtoAnnexA(I):
Ifinanofficially tuberculosis freebovineherdananimalisdeemed
tohavereactedpositively toaroutinemaintenance tuberculin testor
inwhichaclinicalcaseoftuberculosis hasbeendiagnosedatroutine
post-mortem examination andsubsequently confirmed bylaboratory exami­
nationinananimalcomingfromanofficially tuberculosis freeherd
thenthestatus"officiallytuberculosis-free "mustbesuspendeduntil
suchtimeasalloftheremaininganimalsoversixweeksofagehave
reactednegatively toatleasttwoofficialintradermal tuberculintests
inaccordance withAnnexB,thefirstoneatleasttwomonthsafter
completeelimination oftheinfectionintheherdandthesecondoneat
least42dayslater.
4.(a)InAnnexA,(II),(A)(1)(c)intheintroductory sentencethewords"and
castratedmalesover30monthsofage"shallbeinsertedafterthe
words"over12monthsold".
(b)InAnnexA,(II)(A)(2)(c),inthefirstsentencethewords"castrated
malesneednotbesubjectedtotesting",shallbeinsertedafterthe
word"however".
InAnnexA(II)(A)(2)(d)thefollowingsentenceshallbeaddedatthe
endofthefirstparagraph"Castratedmalesneednotbesubjectedto
premovement testing".
(c)InAnnexA(II)(A)(3)(c)inthefirstsentencethewords"andcastrated
malesover30monthsofage"shallbeinsertedafterthewords"over
12monthsold".
5.AnnexBshallbereplacedbytheAnnextothisDirective.
DoneatBrussels, FortheCouncil
ThePresident

ANNEX
"ANNEX B(5)
STANDARDS FOR THE MANUFACTURE AND USE OFBOVINE AND AVIAN TUBERCULINS
1.Officially supervised tuberculin tests must becarried outwith PPD or
HCSM tuberculins .
2.Manufacturers' working standards forthecontrol ofbovine PPD
andHCSM tuberculins must becalibrated inCommunity
tuberculin units (CTU)following biological assay against the
appropriate EEC standard tuberculin intuberculous cattle
and inguinea-pigs .
3.Manufacturers' working standards forthecontrol ofavian
tuberculins must becalibrated ininternational units following
biological assay against theEEC standard forPPD ofAvian Tuberculin .
4.TheEECstandard forPPDofBovine Tuberculin isthat supplied bythe
Centraal Diergeneeskundig Instituut ,Afdeling Rotterdam , Netherlands .
5.TheEEC standard forBovine HCSM Tuberculin isthat supplied bythe
Institut Pasteur ,Paris ,France .
6.TheEECstandard forAvian Tuberculin isthat supplied bytheCentral
Veterinary Laboratory ,Weybridge ,Surrey ,England .
7.Bovine tuberculins must beprepared with oneoftheMycobacterium bovis
strains indicated below :
(a)AN5 ;
(b)Vallee ;
8.Avian tuberculins must beprepared with oneoftheMycobacterium avium strains
indicated below :
(a)D4ER ;
(b)TB56 .
9.ThepHoftuberculins must bebetween 6.5and7.5 .

-§-
10.Antimicrobial preservatives orother substances that may beadded to
atuberculin shall have been shown ,tothesatisfaction ofthe state
institute responsible for theofficial testing ofthetuberculin ,not
toimpair thesafety andeffectiveness oftheproduct .
The following are themaximum permitted concentrations forphenol and
glycerol :
(a)phenol -0.5% M/v
(b)glycerol -10%v/v
11.Provided thetuberculins are stored atatemperature between 2°C and
8°C ,protected from light ,they maybeused uptotheendofthe
following periods subsequent tothelast satisfactory potency test :
(a)liquid PPDtuberculins :twoyears
lyophilized PPDtuberculins :eight years
(b)HCSM tuberculins
diluted :twoyears
12.The state institutes listed below must bemade responsible for the
official testing oftuberculins intheir respective countries :
(a)Germany :Paul -Ehrlich -Institut ,Frankfurt /Main ;
(b)Belgium :Instituut voor Hygiëne enEpidemiologie ,J.Wytsman -
straat 14,B1050 Brussels ;
(c)France :Laboratoire National desMédicaments Vétérinaires ,
Fougères ;
(d)Grand Duchy ofLuxembourg :Institute ofthesupplying country ;
(e)Italy : Istituto Superiore diSanità ,Rome ;
(f)Netherlands :Centraal Diergeneeskundig Instituut ,Afdeling
Rotterdam ;
(g)Denmark :Statens Veterinaere Serumlaboratorium ,Copenhagen V;
(h)Ireland :Institute ofthesupplying country ;
(i)United Kingdom :TheCentral Veterinary Laboratory ,Weybridge ,
Surrey ,England .
13.Official testing must becarried outoneach batch ofbottled
tuberculins ready foruse .

-6-
14.Tuberculins shall betested bybiological andchemical methods .
15-Tuberculins must besterile .Tests forsterility shall becarried out
according tothespecifications oftheEuropean Pharmacopoeia .
16.Atest fortheabsence oftoxic orirritant properties shall be
carried outaccording tothespecifications oftheEuropean Pharma­
copoeia .
17.Tuberculins must bechemically analysed todetermine theconcentration
ofglycerol and/orphenol andalso theconcentration ofanyother
preservative which may have been added .
18.Atest ofnon-sensitization totuberculin must becarried out
according tothespecifications oftheEuropean Pharmacopoeia .
19.Thepotency oftuberculins must beestimated bybiological methods .
These methods must beused forHCSM andPPD tuberculins ;they are
based onthecomparison with standard tuberculins ofthetuberculins
tobetested .

-7-
20.Theprotein content ofPPDtuberculin must beestimated bythe
Kjeldahl method .Thenitrogen isconverted into tuberculo-protein
content bymultiplying byafactor of6.25 .
21.TheEEC standard forBovine HCSM has apotency of65,000
community tuberculin units (CTU)perml.and isdispensed in
ampoules containing 5mloftuberculin .
22.TheEEC standard forBovine PPDhas apotency of50,000 Community
tuberculin Units (CTU)permg.ofPPDandisdispensed inthelyophilized
state inampoules containing 1.8mgofPPD ,i.e. 0.00002 mgPPD contains
one community tuberculin unit ofactivity .
23.TheEEC standard forPPD ofAvian Tuberculin has apotency of50,000
International Units (IU)permg.ofthedried material ofthepurified
protein derivative and isdispensed inthelyophilized state inampoules
containing 10mgofPPDplus 26.3 mgofsalts ,i.e. 0.0000726 mgofthe
standard contains one international unit ofactivity .
24.Tuberculins submitted bymanufacturers fortesting bythe state
institutes listed inparagraph 12must have been tested forpotency by
biological assay against theappropriate standards aslisted in
paragraphs 2and 3.
25.(a)Potency testing onguinea pigs
Albino guinea-pigs weighing between 400and600gmust beused .
These guinea pigs must beingood health atthetime ofthe
tuberculin inoculation .Not less than eight guinea-pigs shall be
used foreach assay .Theassay should bemade not less than one
month after sensitization .23 .
24 .

-θ-
(aa)Fortheassay ofbovine tuberculins ,guinea-pigs shall be
sensitized byoneofthefollowing methods :
(1)theinjection ofheat killed Mycobacterium bovis strain
AN5 inoiladjuvant
(2)theinjection ofliving Mycobacterium bovis strain AN5
inphysiological saline
(3)theinjection ofB.C.G. vaccine .
(bb)Fortheassay ofavian tuberculins ,guinea-pigs shall be
sensitized byinjection of2mgofheat-killed avian type
tubercle bacilli suspended in0.5mlofsterile liquid
paraffin orbytheinjection oflive avian type tubercle
bacilli inphysiological saline .
Theavian type strain D4must beused forthis purpose .
(cc)Each tuberculin under test shall beassayed against the
appropriate standard tuberculin byanintradermal assay
using groups ofguinea-pigs suitably sensitized .
Thehair shall beclipped from both sides ofeach guinea-pig .
Theassay shall becarried outbycomparing thereactions
induced byaseries ofintracutaneous injections ofdoses of
0.2 mlofdilutions ofthe standard tuberculin inisotonic
buffered saline solution containing Tween 80,0.0005 per
cent ,with acorresponding series ofinjections ofthe
tuberculin under test .Dilutions shall bearranged in
geometric series ,andinjected into guinea-pigs according to
arandomised Latin square design (four sites oneach side of
aneight-point assay isused ).Thediameters ofthe
reactions ateach site should bemeasured and recorded after
24to28hours . '

-9-
For each sample oftuberculin under test ,anestimate of
relative potency against theappropriate standard and its
fiducial limits shall bemade bystatistical methods ,using
thediameters ofthe reactions and thelogarithms ofthe
doses asmetameters .The bovine tuberculin under test isof
acceptable potency ifitsestimated potency guarantees per
bovine dose 2000 C.T.U. 's(+25%)incattle .Thepotency
ofeach tuberculin under test shall beexpressed as
appropriate inCommunity tuberculin units orInternational Units
per m.l .
(b)Potency testing onbovine animals
Periodic potency testing ofbovine tuberculins must becarried
out onnaturally orartificially infected tuberculous cattle .
These potency tests ,ingroups oftuberculous cattle shall be
carried outbyintradermal four orsix-point assay ofthe
tuberculin under test against theappropriate standard and the
potency ofthetuberculin estimated bystatsticial methods asin
theguinea-pig assay .
26.Thefollowing requirements shall apply tothelabelling oftuberculin
containers andpackages :
The label onthecontainers andthelabel onthepackage shall state :
thename ofthepreparation
forliquid preparations ,thetotal volume inthecontainer
thenumber ofCommunity orInternational Units per
mlorpermg .
the manufacturers name
the batch number
thenature andquantity ofthereconstituting liquid forthe
freeze-dried preparation

-10-
The label onthecontainer orthelabel onthepackage shall state :
theexpiry date
theconditions ofstorage
thename andproportions ofanyadded substance
the species orthebacillus from which thetuberculin hasbeen
made .
27.Community laboratories will beestablished fortheperiodic examina­
tion ofroutine issue field tuberculins used inthe Member States to
ensure that thepotency ofeach ofthese tuberculins isadequate in
relation totheappropriate community standard tuberculin .These
examinations must becarried out ,intuberculous bovines ,insuitably
sensitized guinea-pigs andbyappropriate chemical tests .
TheCouncil acting onaproposal from theCommission shall designate
thecommunity laboratories before January 1,1984 .
Under theprocedure laid down inArticle 12,theStanding Veterinary
Committee will nominate the tuberculins tobetested and the examina­
tions tobecarried outandmayamend thelist oflaboratories where
t
these examinations are tobeeffected .
Thefollowing shall berecognized asofficial intradermal tuberculin
tests :
(a)TheSingle Intradermal Test -this test requires asingle
injection ofbovine tuberculin .
(b)TheIntradermal Comparative Test -this test requires one
injection ofbovine tuberculin andoneinjection ofavian
tuberculin given simultaneously .
Thedose oftuberculin injected shall be:
(1)not less than 2000 C.T.U. 'sofbovine tuberculin
(2)not less than 2000 I.U. 'sofavian tuberculin .
Thevolume ofeach injection dose shall notexceed 0.2ml.28.
29 .

-11-
30.Tuberculin tests shall becarried outbyinjecting tuberculin(s )into
theskin oftheneck .The injection sites shall besituated atthe
border ofthe anterior and middle thirds ofthe neck .When both avian
andbovine tuberculins are injected inthe same animal ,the site for
injection ofavian tuberculins shall beabout 10cmfrom thecrest of
theneck and the site for theinjection ofbovine tuberculin about
12.5 cmlower onaline roughly parallel with the line ofthe shoulder
orondifferent sides oftheneck particularly inyoung animals in
which there isnot room toseparate the sites sufficiently onone side
oftheneck ,oneinjection shall bemade oneach side oftheneck at
identical sites inthe centre ofthe middle third ofthe neck .
31.Thetechnique oftuberculin testing andinterpretation ofreactions
shall beasfollows :
(a)Technique :
Injection sites shall beclipped andcleansed .Afold ofskin
within each clipped area shall betaken between the forefinger
andthumb andmeasured with acalipers and recorded .Ashort sterile
needle ,bevel edge outwards ,with graduated syringe charged with
tuberculin attached ,shall beinserted obliquely into thedeeper
layers oftheskin .The dose oftuberculin shall then beinjected .
Acorrect injection shall beconfirmed bypalpating asmall pea-
like swelling ateach site ofinjection .The skin-fold thickness
ofeach injection site shall beremeasured 72hrsafter
injection and recorded .
(b)Interpretation ofreactions :
The interpretation ofreactions shall bebased onclinical observations
andtherecorded increase(s )inskin-fold thickness atthesites of
injection 72hrsafter injection oftuberculin(s ).
(ba)Negative reaction :Ifonly limited swelling isobserved ,
with anincrease ofnot more than 2mminthe thickness of
thefold ofskin without clinical signs such asdiffuse or
extensive oedema ,exudation ,necrosis ;pain orinflammation
ofthelymphatic ducts inthat region orofthelymph nodes .

-12-
(bb)Inconclusive reaction -ifnoclinical signs such as
mentioned in (ba)areobserved and ifthe increase inskin-
fold thickness ismore than 2mmand less than 4mmthen
this reaction maybeconsidered asbeing inconclusive .
(be)Positive reaction :Ifclinical signs such asmentioned in
(ba)areobserved orthere isanincrease of4mmormore in
thethickness ofthefold ofskin attheinjection site .
32.The Interpretation ofofficial intradermal tuberculin tests shall be
asfollows :
(a)Single Intradermal Test
Positive : Apositive bovine reaction asdefined inparagraph
31 (bc)
Inconclusive :Aninconclusive reaction asdefined inparagraph
31 (bb)
Negative : Anegative bovine reaction asdefined inparagraph
31 (ba)
(aa)Animals inconclusive tothesingle intradermal test
shall besubjected toanother test after aninterval of42
days .Animals which are notnegative tothis second test
shall bedeemed tobepositive tothe test .
Animals positive tothe single intradermal test may be
subjected toanintradermal comparative test .
(b)Intradermal Comparative Test
(ba)For theestablishment andmaintenance ofofficially
tuberculosis free herds theinterpretation ofthetest shall
beasfollows :
Positive : Apositive bovine reaction andmore than
4mmgreater than theavian reaction orthe
presence ofclinical signs .
Inconclusive :Apositive bovine reaction andfrom 1to4mm
greater than theavian reaction andtheabsence
ofclinical signs
Negative : Anegative bovine reaction
or
apositive bovine reaction butequal toor
less than apositive avian reaction and theabsence
ofclinical signs inboth cases .

-13-
Animals inconclusive tothe intradermal comparative test
shall besubjected toanother test after aninterval of42
days .Animals which arenotnegative tothis second test
shall bedeemed tobepositive tothe test .
(bb)Animals destined forintra-community trade must besubjected
toasingle intradermal test within 30days prior to
movement ,any animal which shows anincrease inskin-fold
thickness greater than 2mmorthepresence ofclinical signs
must not beentered into intra-community trade .
(c)Thequalification ofofficial tuberculosis herd freedom must be
suspended until such time asthe status ofthe following animals
isresolved :
(1)Animals which have been deemed tobeinconclusive tothe
single intradermal tuberculin test .
(2)Animals which have been deemed tobepositive tothesingle
intradermal tuberculin test but areawaiting retest with
anintradermal comparative test .
(3)Animals which have been deemed tobeinconclusive tothe
intradermal comparative test .