NoC172/16 OfficialJournaloftheEuropeanCommunities 8.7.92
ProposalforaCouncilDirectiveintroducingCommunitymeasuresforthecontrolofcertain
fishdiseases
(92/C172/07)
COM(92)204final
(SubmittedbytheCommissionon19June1992)
THECOUNCILOFTHEEUROPEAN COMMUNITIES ,
HavingregardtotheTreatyestablishingtheEuropean
EconomicCommunity,andinparticularArticle43
thereof,
HavingregardtotheproposalfromtheCommission,
HavingregardtotheopinionoftheEuropean
Parliament,
HavingregardtotheopinionoftheEconomicand
SocialCommittee,
WhereasfisharelistedinAnnexIItotheTreaty;
whereasthemarketingoffishconstitutesanimportant
sourceofrevenuefortheaquaculturesector;
WhereasitisnecessarytoestablishatCommunitylevel
thecontrolmeasurestobetakenintheeventof
outbreaksofdisease,inordertoensurerationaldevel­
opmentoftheaquaculturesectorandtocontributeto
theprotectionofanimalhealthintheCommunity;
Whereasitisnecessary,forthediseasestobecovered,to
refertothelistslaiddowninAnnexAtoCouncil
Directive91/67/EECof28January1991concerningthe
animalhealthconditionsgoverningtheplacingonthe
marketofaquacultureanimalsandproducts(');
Whereasanoutbreakofsuchdiseasescanquicklytake
onepizooticproportions,causingmortalityanddistur­
bancesonascaleliabletoseverelyreducetheprofita­
bilityofaquaculture ;
Whereascontrolmeasuresmustbetakenassoonasthe
presenceofsuchadiseaseissuspectedsothatimmediate
andeffectiveactioncanbeimplementedassoonasits
presenceisconfirmed;
Whereasthemeasurestobetakenmustbeaimedat
preventingthespreadofthediseaseand,inparticular,by
carefullycontrollingmovementsoffishandproducts
liabletospreadtheinfection;Whereasthepreventionofthesediseasesinthe
Communityshallbebasednormallyonanon-vacci­
nationpolicy;whereashoweveritisnecessarytomake
provisionforvaccinationwhereaserioussituation
demandssuchaction;
Whereas,inordertogivethenecessaryguarantees,the
vaccineusedmustbeapprovedforactivitybyareference
laboratorydesignatedbytheCommunity ;
Whereasathoroughepidemiological enquiryisessential
topreventanyspreadofthesediseases;
Whereas,inordertoensureaneffectivesystemof
control,diagnosisofthesediseasesmustbeharmonized
andmustbecarriedoutundertheauspicesofresponsible
laboratories,thecoordinationofwhichmaybecarried
outbyareferencelaboratorydesignatedbythe
Community ; 4
Whereascommonmeasuresforthecontrolofthese
diseasesformabasisformaintainingauniformstandard
ofanimalhealth,
HASADOPTEDTHISDIRECTIVE :
CHAPTER I
Generalprovisions
Article1
ThisDirectivedefinestheminimumCommunitycontrol
measurestobeappliedintheeventofasuspectedor
confirmedoutbreakofthefishdiseasesreferredtoin
listsIandIIofAnnexAtoCouncilDirective
91/67/EEC.
Article2
ForthepurposeofthisDirective,thedefinitionslaid
downinArticle2ofDirective91/67/EECshallapply.
Inaddition,thefollowingdefinitionsshallapply:
1.listIdisease:fishdiseasereferredtoinlistIofAnnex
AtoDirective91/67/EEC;
2.listIIdisease:fishdiseasereferredtoinlistIIof
AnnexAtoDirective91/67/EEC;
3.fishsuspectedofbeinginfected:fishshowingclinical
signsorpost-mortem lesionsorreactionsin
laboratorytestsindicatingthepossiblepresenceofa
listIorIIdisease;(')OJNoL46,19.2.1991,p.1.

8.7.92 OfficialJournaloftheEuropeanCommunities NoC172/17
4.infectedfish:fishinwhichthepresenceofalistIorII
diseasehasbeenofficiallyconfirmedastheresultofa
laboratoryexamination ;
5.farmsuspectedofbeinginfected:farmcontainingfish
suspectedofbeinginfected;
6.infectedfarm:farmcontaininginfectedfish.
Article3
AllfarmsrearingorkeepingfishsusceptibletolistIorII
diseasesmust:
1.beregisteredbytheofficialservice;thisregistermust
beconstantlykeptunderreview;
2.keeparecordopentoscrutinybytheofficialservice:
(a)forlivefish,eggsandgametesenteringthefarm,
containingthedataofdelivery,theirnumberor
weight,theirsourceandsupplies,andthesizeof
thefish;
(b)forlivefish,eggsandgametesleavingfarms,
containingthedataofdispatch,theirnumberor
weight,theirdestination,andthesizeofthefish.2.Ifthesuspicionofinfectionisjustified,theofficial
serviceisresponsiblefortheexecutionandsupervisionof
theprovisionslaiddowninthisDirective.
3.Wheninfectionissuspectedonafarm,theofficial
serviceshallhavethefarmplacedunderofficial
surveillance,andshallinparticularorderthat:
—anofficialcensusbemadeofallcategoriesoffish
andthat,inrespectofeachofthesecategories,the
estimatednumbersoffishalreadydead,infectedor
liabletobeinfectedberecorded;thecensusmustbe
keptuptodatebytheownerorkeepertotake
accountoftheincreaseofthepopulationornew
mortalityduringtheperiodofsuspicion;theinfor­
mationinthecensusmustbeproducedonrequest
andmaybecheckedateachinspection,
—nofishwhetheraliveordeadoreggsenterorleave
thefarmwithouttheauthorization oftheofficial
service,
—thedisposalofdeadfishortheiroffalbecarriedout
underthesupervisionoftheofficialservice,
—theentryorexitoffeedingstuffs ,utensils,objectsor
othersubstancessuchaswasteliabletotransmit
diseasebesubject,ifnecessary,toauthorizationby
theofficialservicewhichshalllaydownthe
conditionsinordertopreventthespreadoftheagent
ofthedisease,
—themovementofpersonstoorfromthefarmbe
madesubjecttotheauthorization bytheofficial
service,
—theentryorexitofvehiclestoorfromthefarmbe
madesubjectifnecessarytoauthorization bythe
officialservicewhichshalllaydowntheconditions
necessaryinordertoavoidthespreadoftheagentof
thedisease,
—appropriatemeansofdisinfectionbeusedatthe
entrancesandexitsofthefarm,
—anepizootiological investigationbecarriedoutin
accordancewithArticle7(1),
—allthefarmssituatedinthesamewatercatchment
areaorcoastalareabeplacedunderofficial
surveillance,andnofishoreggsleavethesefarms
withouttheauthorization ofthecompetent
authority;inthecaseofextensivewatercatchment
areas,theofficialservicemaydecidetolimitthis
measuretoanareaupstreamanddownstreamofthe
farmsuspectedofbeinginfected,ifthisareais
consideredtogivemaximumguaranteesforthe
preventionofthespreadofthedisease;ifnecessary,
theofficialservicesofneighbouringMemberStatesArticle4
1.AnysuspicionofthepresenceofalistIorII
diseaseinfishmustimmediatelybenotifiedtothe
officialserviceand,whereappropriate,totheowneror
keeperofthefishbythemostexpeditiousmeans
available.
2.Untilsuchtimeasthemeasureslaiddownin
Article5(3)areenforced,theownerorkeeperofthe
fishsuspectedofbeinginfectedshalltakeallactionto
ensurecompliancewiththesaidparagraphs.
CHAPTER II
ControlmeasuresforlistIdiseases
Article5
1.Whereinformationconcerningfishsuspectedof
beinginfectedwithalistIdiseaseisreceived,theofficial
serviceshallimmediatelysetinmotionofficialmeansof
investigationtoconfirmorruleoutthepresenceofthe
agentofthedisease,inparticularbyclinicalinvestigation
and,wherenecessary,bythetakingofsamplesfor
laboratoryexaminationinanapprovedlaboratory.

NoC172/18 OfficialJournaloftheEuropeanCommunities 8.7.92
(b)inthewatercatchmentareaorinthecoastalzonein
whichtheinfectedfarmissituated,allfarmssituated
inthesameareaaresubmittedtohealthinspections;
iftheseinspectionsrevealpositivecases,the
measuresasprovidedforunder(a)shallbeapplied;
(c)whereitisconsideredthattheinfectionoccursin
fishotherthanonafishfarm,appropriatemeasures
equivalenttothoselaiddownunder(a)shallbe
taken;
(d)therepopulationofthefarmshallbeauthorizedby
theofficialservice,followingsatisfactoryinspection
ofthecleaninganddisinfectionoperationsandafter
anappropriateperiodhaselapsedtoensurecomplete
eliminationoftheagentofthedisease,andthe
eradicationofotherpossibleinfectionsinthesame
watercatchmentarea;
(e)incasethemeasureslaiddownunder(a),(b),(c)
and(d)requirethecooperationoftheofficial
servicesofotherMemberStates,theofficialservices
oftheMemberStatesconcernedshallcollaborateto
ensuretherespectofthemeasureslaiddowninthis
Article.Wherenecessary,appropriatemeasuresare
establishedinaccordancewiththeprocedurelaid
downinArticle15.orthirdcountriesmustbeinformedaboutthe
suspicion.Inthatevent,theofficialservicesofthe
MemberStatesinvolvedshalltakeappropriateaction
toapplythemeasureslaiddowninthisArticle.
Wherenecessary,appropriatemeasuresareestab­
lishedinaccordancewiththeprocedurelaiddownin
Article15.
4.Wheresuspicionoccursinfishotherthanonafish
farm,theofficialserviceshalltakethemeasures
necessarytopreventapossiblespreadofthedisease,and
shallinparticularorderthatmeasuresequivalenttothose
laiddowninparagraph3betaken.
5.Themeasuresreferredtoinparagraphs3and4
shallnotbewithdrawnuntilthesuspicionofdiseasehas
beenofficiallyruledout.
Article6
1.Assoonasconfirmation ofinfectionofalistI
diseasehastakenplace,inadditiontothemeasureslisted
inArticle5,theofficialserviceshallintroducethe
followingmeasures :
(a)intheinfectedfarm:
—theinflowandoutflowofwaterthroughany
land-basedfarmshallbestopped,andin
cage-basedfarms,stockshallberemoved
immediately ,
—alllivefishandeggsmustbedestroyedunderthe
supervisionoftheofficialserviceinsuchawayas
toavoidallriskofspreadingtheagentofthe
disease;however,themarketingorprocessingfor
humanconsumptionoffishorpartsthereofmay
beauthorizedbytheofficialserviceiftheseoper­
ationsarecarriedoutinconditionssuchasto
preventthespreadofpathogens;inthatevent,
theoffalsofthefishmustbesubmittedtoa
treatmentwhichinactivatesdisease-causing
agentspossiblypresenttherein,
—afterslaughteranddestructionofthefish,ponds,
equipmentandanymaterialliabletobe
contaminatedmustbedisinfectedfollowingthe
instructionsestablishedbytheofficialservice
wherenecessary,inaccordancewiththe
procedurelaiddowninArticle15,
—anysubstanceswhichmightbecontaminated ,
referredtoinArticle5(3),fourthindent,shallbe
destroyedortreatedinsuchawayastoensure
thedestructionofanyagentofthedisease
present,
—anepizootiological enquiryshallbecarriedoutin
accordancewithArticle7(1)andtheprovisions
ofArticle7(4)shallbeapplied;thisenquiryshall
includethetakingofsamplesforlaboratory
examination ;2.Inthecaseofanexceptionalseverityofthe
spreadingofadisease,additionalmeasuresmaybetaken
inaccordancewiththeprocedurelaiddowninArticle
15.
Article7
1.Theepizootiological investigationshalldealwith:
—thelikelylengthoftimeduringwhichthedisease
mayhaveexistedonthefarmbeforebeingnotified
orsuspected,
—thepossibleoriginofthediseaseonthefarmandthe
identification ofotherfarmsonwhichthereare
animalsofsusceptiblespecieswhichmayhave
becomeinfected,
—themovementoffish,persons,vehiclesand
substanceslikelytohavecarriedtheagentofthe
diseasetoorfromthefarmsinquestion,
—thepossibleexistenceofcarriersofthedisease,and
theirdistribution .
2.Ifthisepizootiological investigationrevealsthatthe
diseasecouldhavebeenintroducedfromanother

8.7.92 OfficialJournaloftheEuropeanCommunities NoC172/19
2.Iftheepizootiological enquiryreferredtoinArticle
7(1)revealsthatthediseasecouldhavebeenintroduced
fromanapprovedzoneorfromanotherapprovedfarm,
orcouldhavebeentransferredtoanotherapprovedfarm
asaresultofthemovementofpersons,animalsor
vehiclesorinanyotherway,thosezonesorfarmsshall
beconsideredasbeingsuspectedandtheappropriate
measuresshallapply;
3.AsaderogationfromArticle6(1)(a)second
indent,theofficialservicemayallowafatteningperiod
tobeappliedtofishuntiltheyreachcommercialsize.
TherequirementsofthisArticleshallnotapplytofish
speciessuchastropicalfishwhicharenotcarriersof
disease.watercatchmentareaorcouldhavebeentransferredto
anotheroneasaresultofthemovementoffishorother
animals,personsorvehiclesorinanyotherway,the
farmsbelongingtosuchwatercatchmentareashallbe
consideredasbeingsuspectedandthemeasureslaid
downinArticle5shallapply.Incaseofconfirmationof
thepresenceofthedisease,themeasureslaiddownin
Article6shallapply.
3.Ifthisepizootiological investigationrevealsthat
cooperationwiththeofficialservicesofotherMember
Statesisrequired,theofficialservicesoftheMember
Statesconcernedshallcollaboratetotakeappropriate
stepstoensuretherespectofthemeasuresprovidedfor
bythisDirective .
4.Inordertoprovidefullcoordinationofall
measuresnecessarytoensureeradicationofthedisease
asquicklyaspossibleandforthepurposeofcarryingout
theepizootiological enquiry,acrisisunitshallbeestab­
lished.
Thegeneralrulesconcerningnationalcrisisunitsandthe
CommunitycrisisunitfixedbyCouncilRegulation
(EEC)No...Oshallapply.
CHAPTERIII
ControlmeasuresforlistIIdiseases
Article8
1.TherequirementslaiddowninArticles5,6and7
shallapply:
(a)inazoneapprovedinaccordancewithArticle5of
Directive91/67/EEC;
(b)inazoneforwhichaprogrammehasbeenapproved
inaccordancewithArticle10(2)ofDirective
91/67/EEC.
2.TherequirementsofthisArticleshallnotapplyto
fishspeciessuchastropicalfishwhicharenotcarriersof
disease.
Article9
1.TherequirementsofArticle5(1),(2),(3)indents1
to8,and(5),Article6(1)(a)and(d)aswellasArticle7
(1)shallapply:
(a)inafarmapprovedinaccordancewithArticle6of
Directive91/67/EEC;and
(b)inafarmforwhichaprogrammehasbeenapproved
inaccordancewithArticle10,paragraph2of
Directive91/67/EEC.Article10
1.TherequirementsofthisArticleshallapplyina
non-approved farmsituatedinanon-approvedzone.
2.Whereanon-approved farmsituatedina
non-approved zonecontainsfishsuspectedofbeing
infectedwithalistIIdisease,theofficialservicesshall
immediatelysetinmotionofficialmeansofinvestigation
toconfirmorruleoutthepresenceofthedisease,
involvingwherenecessarythetakingofsamplesfor
laboratoryexaminationinanapprovedlaboratory .
3.IncaseswherethepresenceofalistIIdiseaseis
officiallyconfirmed,themovementoffishoreggsfrom
thatfarmonpublicorprivateroadsisprohibited .
However,removaloflivefishoreggsfromsuchfarms
canbepermittedfrombeingtransportedtoanother
infectedfarmortoaslaughterpremisesforthepurpose
ofimmediateslaughter,suchtransportbeingauthorized
bytheofficialservice.Theslaughteroffalsmustbe
submittedtoatreatmentenablingthedestructionof
disease-causing agents.
CHAPTERIV
Finalarrangements
Article11
1.Samplingandlaboratorytestingtodetectthe
presenceoflistIandIIdiseasesshallbecarriedoutin
accordancewiththemethodsestablishedinaccordance
withtheprocedurelaiddowninArticle15ofDirective
91/67/EEC.
2.Laboratorytestingtodetectthepresenceofdisease
shallbecarriedoutbyalaboratoryapprovedbythe
officialservice.Thislaboratorytestingshall,ifnecessary
andespeciallyonthefirstappearanceofthedisease,
showthetype,sub-typeorthevariantoftherelevant (*)OJNoL...

NoC172/20 OfficialJournaloftheEuropeanCommunities 8.7.92
disease-causing agent,whichmaybeconfirmed,if
necessary,byareferencelaboratorydesignatedbythe
Community .MemberStatesshallcommunicate the
namesoftheapprovedlaboratoriestotheCommission
andtheMemberStates.
3.TheapprovedlaboratoriesintheMemberStates
shall,ifnecessary,throughanationalreference
laboratoryappointedbytheofficialserviceofthe
MemberStates,liaisewiththeCommunityreference
laboratoryreferredtointheAnnex.
4.TheCommunityreferencelaboratorydesignatedin
AnnexAshallbechargedwiththetasksdefinedin
AnnexB.Theconditionsunderwhichthislaboratory
shalloperateshallbeestablishedinaccordancewiththe
procedurelaiddowninArticle15,insofarastheseare
notyetcoveredbyArticle28ofCouncilDecision
90/424/EECof26June1990onexpenditureinthe
veterinaryfield(1).TheCommissionshallapprovetheplans,ifnecessary
amended,inaccordancewiththeprocedurelaiddownin
Article15.
Theplansmaysubsequently beamendedor
supplemented ,inaccordancewiththesameprocedure,
totakeintoaccountdevelopments inthesituation.
Article13
1.VaccinationagainstlistIIdiseasesinapproved
zonesandinapprovedfarmssituatedinnon-approved
zonesisprohibited .However,ifanoutbreakofalistII
diseaseoccursinanapprovedzoneorinanapproved
farmsituatedinanon-approvedzoneandthreatensto
becomeextensive,itmaybedecided,inaccordancewith
theprocedurelaiddowninArticle15,thatvaccination
maybeintroducedsubjecttospecifiedconditions.These
conditionsmayincludethedefinitionof:
—thegeographicalareainwhichthevaccinationis
carriedout,
—thespeciesandsizeclassofthefishtobevaccinated,
—thedurationofthevaccinationcampaign,
—thetypeofvaccinetobeusedandthewaythe
vaccinehastobeapplied,
—othermattersappropriatetotheemergencysituation.
2.Themovementoffishfromsuchavaccinationzone
willbesubjecttoanyconditionslaiddowninaccordance
withtheprocedureofArticle15.
3.MemberStatesshallinformtheCommissionofthe
progressofthevaccinationmeasuresonaregularbasis.
Adecisionmaybetakeninaccordancewiththe
procedurelaiddowninArticle15,tomodify,extendor
terminatethemeasures.
Article14
TheCommissionshallbeassistedbytheStanding
VeterinaryCommitteesetupbyCouncilDecision
68/361/EEC(3),hereinafterreferredtoas'the
committee'.Article12
1.EachMemberStateshalldrawupacontingency
plan,specifyinghowitwillimplement,intheeventofan
outbreakofalistIdisease,themeasureslaiddownin
thisRegulation .
Thisplanshouldallowaccesstofacilities,equipment,
personnelandallotherappropriatematerialsnecessary
fortherapidandefficienteradicationoftheoutbreak.
2.Thecriteriatobeappliedfordrawingupthose
plansshallbethoselaiddowninCommissionDecision
91/42/EECof8January1991,layingdownthecriteria
tobeappliedwhendrawingupcontingencyplansforthe
controloffoot-and-mouth disease(2),whichshallapply
mutatismutandis.
TheCommissionmay,inaccordancewithArticle15,
amendorsupplementthosecriteriatakenintoaccount
thespecificnatureofthedisease.
3.Plansdrawnupinaccordancewiththecriteria
providedforinparagraph2shallbesubmittedtothe
Commissionnotlaterthan1April1993.
4.TheCommissionshallexaminetheplansinorder
todeterminewhethertheypermitthedesiredobjectiveto
beattainedandshallsuggesttotheMemberState
concernedanyamendmentsrequired,inparticularto
ensurethattheyarecompatiblewiththoseoftheother
MemberStates.Article15
WheretheprocedurelaiddowninthisArticleistobe
used,thefollowingrulesshallapply:
TherepresentativeoftheCommissionshallsubmittothe
committeeadraftofthemeasurestobetaken.The
(')OJNoL224,18.8.1990,p.19.
OOJNoL23,29.1.1991,p.29. OOJNoL255,18.10.1968,p.23.

8.7.92 OfficialJournaloftheEuropeanCommunities NoC172/21
committeeshalldeliveritsopiniononthedraftwithina
timelimitwhichthechairmanmaylaydownaccording
totheurgencyofthematter,ifnecessarybytakinga
vote.Article16
TheMemberStatesshallbringintoforcethelaws,regu­
lationsandadministrativeprovisionsnecessarytocomply
withtheprovisionsofthisDirectivenotlaterthan
1January1993.
WherethesemeasuresareadoptedbytheMemberStates
theyshallcontainareferencetothisDirectiveorshallbe
accompaniedbysuchreferenceontheoccasionoftheir
officialpublication .Themethodsofmakingsuch
referenceshallbelaiddownbytheMemberStates.
Article17
ThisDirectiveisaddressedtotheMemberStates.Theopinionshallberecordedintheminutes;in
addition,eachMemberStateshallhavetherighttoask
tohaveitspositionrecordedintheminutes.
TheCommission shalltaketheutmostaccountofthe
opiniondeliveredbythecommittee.Itshallinformthe
committeeofthemannerinwhichitsopinionhasbeen
takenintoaccount.
ANNEXA
Communityreferencelaboratoryfor*fishdiseases
TheCommunityreferencelaboratoryforfishdiseasesis:
StatensVeterinaereSerumlaboratorium ,
Landbrugsministeriet ,
Hangovej2,
DK-8200AarhusN.
ANNEXB
DutiestobefulfilledbytheCommunityreferencelaboratoryreferredtoinAnnexA
TheCommunityreferencelaboratoryshallbechargedwith:
—identificationofvirusisolates,
—supplyofdiagnosticreagentsofgoodqualityonrequest,
—approvalofdiagnosticreagentsproducedbyotherlaboratoriesonthebasisoftitrationandspecificity
testing,
—establishmentofcontactwithnon-Community researchlaboratorieswithregardtoadvancedstudiesof
virusespreviouslynotidentifiedinsidetheCommunity,
—theorganizationofcomparativeCommunitytestsatregularintervals,
—holdisolatesofdisease-causing agentsfromconfirmedoutbreaks,
—wherenecessarytheapprovalofvaccinestobeusedundertheconditionslaiddowninthisDirective.