1985L0511—EN—01.01.1995—003.001—1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE
of18November1985
introducingCommunitymeasuresforthecontroloffoot-and-mouthdisease
(85/511/EEC)
(OJL315,26.11.1985,p.11)
Amendedby:
OfficialJournal
No page date
►M1CouncilDirective90/423/EECof26June1990 L224 13 18.8.1990
►M2CommissionDecision92/380/EECof2July1992 L198 54 17.7.1992
Amendedby:
►A1ActofAccessionofAustria,SwedenandFinland C241 21 29.8.1994
(adaptedbyCouncilDecision95/1/EC,Euratom,ECSC) L1 1 1.1.1995
Correctedby:►
C1Corrigendum,OJL14,18.1.1986,p.19(85/511/EEC)
►C2Corrigendum,OJL296,27.10.1990,p.66(90/423/EEC)
▼B
COUNCILDIRECTIVE
of18November1985
introducing Community measures for the control of foot-and-
mouthdisease
(85/511/EEC)
THECOUNCILOFTHEEUROPEANCOMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community,andinparticularArticles43and100thereof,
HavingregardtotheproposalfromtheCommission(1),
HavingregardtotheopinionoftheEuropeanParliament(2),
Having regard to the opinion of the Economic and Social
Committee(3),
Whereas one of the Community's tasks in the veterinary field is to
improve the state of health of livestock, thereby increasing the profit-abilityofstockfarming;
Whereas an outbreak of foot-and-mouth disease can quickly take on
epizootic proportions, causing mortality and disturbances on a scaleliable to reduce sharply the profitability of farming of pigs and rumi-nantsasawhole;
Whereasactionmustbetakenassoonasthepresenceofthediseaseis
suspected so that immediate and effective control measures can beimplemented as soon as its presence is confirmed; whereas suchmeasures must be modulated by the competent authorities to takeaccountofwhetherornotacountrycarriesoutaprophylacticvaccina-
tion programme on all or part of its territory; whereas, under certain
conditions, the Member States which practise such a policy mayauthorizeanimalshavingsufficentimmunizationprotectionagainstthefoot-and-mouthvirustobeexemptedfromslaughter;
Whereasitisnecessarytopreventanyspreadofthediseaseassoonas
anoutbreakoccurs,bycarefullymonitoringmovementsofanimalsandthe useof products liable to be contaminated, and, where appropriate,byvaccination;
Whereas diagnosis of the disease and identification of the relevant
virusmustbecarriedoutundertheauspicesofresponsiblelaboratoriesthe coordination of which must be ensured by a reference laboratoryappointedbytheCommunity;
Whereas the vaccine usedforemergency vaccination mustbeverified
both for efficacy and safety, with coordination being carried out by aspecialized institute appointed by the Community; whereas, further-
more, special coordinated measures must be implemented where virus
types or variants are detected against which the vaccines usually usedin the Community do not provide sufficient protection; whereas itprovesnecessary,tothisend,tomakeprovisionfortheMemberStateswhich vaccinate to draw up multiannual vaccination plans which will
be examined and, where appropriate, be the subject of Community
coordination;
Whereasprovisionmustbemadeforaprocedureforclosecooperation
betweentheMemberStatesandtheCommission;
Whereas the arrangements introduced by this Directive are of an
experimental nature and whereas they will have to be reviewed inkeepingwithdevelopmentsinthesituation,1985L0511—EN—01.01.1995—003.001—2
(1) OJNoC248,22.9.1982,p.3.
(2) OJNoC242,12.9.1983,p.128.
(3) OJNoC77,21.3.1983,p.5.
▼B
HASADOPTEDTHISDIRECTIVE:
Article 1
This Directive defines the Community control measures to be applied
intheeventofoutbreaksoffoot-and-mouthdisease,whateverthetypeofvirusconcerned.
Article 2
ForthepurposesofthisDirective,thedefinitionsgiveninArticle2of
Directive64/432/EEC(
1)shallapplyasappropriate.
Thefollowingdefinitionsshallalsoapply:
(a) ‘animalofasusceptiblespecies’meansanydomesticorwildrumi-
nantorswinepresentonaholding;
(b) ‘receptiveanimal’meansanyanimalofasusceptiblespecieswhich
is not vaccinated, or which is vaccinated but whose immunization
coverisconsideredtobeinadequatebythecompetentauthority;
(c) ‘infectedanimal’meansanyanimalofasusceptiblespecies:
— inwhichclinical symptomsorpost-mortem lesions whichmay
arisefromfoot-and-mouthdiseasehavebeenascertained,
or
— inwhichthepresenceoffoot-and-mouthdiseasehasbeenoffi-
ciallyascertainedfollowingalaboratoryexamination;
(d) ‘animalsuspectedofbeinginfected’meansanyanimalofasuscep-
tible species showing clinical symptoms or post-mortem lesionswhich are such that the presence of foot-and-mouth disease mayreeasonablybesuspected;
(e) ‘animal suspected of being contaminated’ means any animal of a
suspectiblespecieswhichmay—accordingtotheepizootiologicalinformationcollected—havebeendirectlyorindirectlyexposedto
thefoot-and-mouthvirus.
Article 3
MemberStatesshallensurethatthepresence,orsuspectedpresence,of
foot-and-mouth disease is compulsorily and immediately notifiable tothecompetentauthority,inaccordancewithDirective82/894/EEC(
2).
Article 4
1. MemberStatesshallensurethat,whereaholdingcontainsoneor
more animals suspected of being infected or of being contaminatedwithfoot-and-mouthdisease,officialmeansofinvestigationtoconfirmor rule out the presence of the disease are set in motion immediatelyand, in particular, that the official veterinarian takes the necessarysamples,orhasthemtaken,forlaboratoryexamination.
Assoonasthesuspectedinfection isnotified,thecompetent authority
shall have the holding placed under official surveillance and shall inparticularorderthat:
— acensusbemadeofallcategoriesofanimalsofsusceptiblespecies
and that, in respect of each of these categories, the number ofanimals already dead, infected or liable to be infected or contami-nated be recorded; the census must be kept up to date to takeaccount of animals born or dying during the period of suspicion;
the information in the census must be produced on request and
maybecheckedateachvisit;
— all animals of susceptible species on the holding be kept in their
livingquartersorsomeotherplacewheretheycanbeisolated;1985L0511—EN—01.01.1995—003.001—3
(1) OJNo121,29.7.1964,p.1977/64.
(2) OJNoL378,31.12.1982,p.58.▼M1
▼B
▼B
— noanimalsofsusceptiblespeciesenterorleavetheholding;
— no animals of other species enter or leave the holding without the
authorizationofthecompetentauthority;
— all movement from the holding of meat or carcases of animals of
susceptible species or of animal feed, utensils, objects or othersubstance, such as wool or waste or rejected matter, liable totransmit foot-and-mouth disease be prohibited, unless authorized
bythecompetentauthority;
— themovementofmilkfromtheholdingbeprohibited;intheevent
of difficulties in storing the milk on the holding, the competentauthority may authorize the milk to be moved from the holdingunder veterinary supervision to a treatment establishment in order
that it may begiven heat treatment ensuring the destruction ofthe
foot-and-mouthvirus;
— themovementofpersonstoorfromtheholdingbemadesubjectto
authorizationbythecompetentauthority;
— theentryorexitofvehiclestoorfromtheholdingbemadesubject
to authorization by the competent authority which shall lay downthe conditions necessary in order toavoid propagation of the foot-and-mouthvirus;
— appropriatemeansofdisinfectionbeusedattheentrancesandexits
of buildings housing animals of susceptible species and of the
holdingitself;
— an epizootiological inquiry be carried out in accordance with Arti-
cles7and8.
2. Thecompetentauthoritymayextendthemeasuresprovidedforin
paragraph1toadjoiningholdingsshouldtheirlocation,theirconfigura-tion, or contacts with animals from the holding where the disease issuspectedgivereasontosuspectpossiblecontamination.
3. Themeasuresreferredtoinparagraphs1and2shallnotbewith-
drawnuntilthesuspicionoffoot-and-mouthdiseasehasbeenofficiallyruledout.
Article 5
As soon as it has been confirmed that one or more of the animals
definedinArticle2(c)areonaholding,thecompetentauthorityshallintroducethefollowingmeasures:
1) the official veterinarian takes adequate samples or has them taken
for examination by the laboratory referred to in Annex I, wherethese samplesandexaminationshavenotbeentaken orcarried outduringtheperiodofsuspicioninaccordance withthefirstsubpara-
graphofArticle4(1);
2) in addition to the measures listed in Article 4 (1), the following
measuresaretakenwithoutdelay:
— all animals of susceptible species on the holding shall be
slaughtered on the spot under official supervision in such a
way as to avoid all risk of spreading the foot-and-mouthvirus;
— afterbeingslaughtered,theaforementioned animalsshallbe
destroyedunderofficialsupervisioninsuchawaythatthere
isnoriskofspreadingthefoot-and-mouthvirus;
— meat of animals of susceptible species coming from the
holdingandslaughteredduringtheperiodbetweentheprob-able introduction of the disease to the holding and theimplementationofofficialmeasuresshall,whereverpossible,
betracedanddestroyedunderofficial supervisioninsucha
way as to avoid any risk of spreading the foot-and-mouthvirus;
— the carcases of animals of susceptible species which have
died on the holding shall be destroyed under official super-1985L0511—EN—01.01.1995—003.001—4
▼M1
▼B
▼B
vision in such a way as to avoid any risk of spreading the
foot-and-mouthvirus;
— any substance referred to in Article 4 (1), seond subpara-
graph, fifth indent shall be destroyed or treated in such a
wayastoensurethedestructionofanyfoot-and-mouthviruspresent;alltreatmentmustbecarriedoutinaccordancewiththeinstructionsoftheofficialveterinarian;
— milkandmilkproductsshallbedestroyedinsuchawayas
toavoidanyriskofspreadingthefoot-and-mouthvirus;
— aftereliminationoftheanimalsofsusceptiblespeciesandof
the substances referred to in Article 4 (1), second subpara-graph, fifth indent, the buildings used for housing, theirsurroundings and the vehicles used for their transport andall equipment likely to be contaminated shall be cleanedanddisinfectedinaccordancewithArticle10;
— noanimalsofsusceptiblespeciesshallbereintroducedtothe
holding until at least 21 days after completion of the
cleaning and disinfection operations carried out in accor-dancewithArticle10;
— anepizootiologicalinquiryshallbecarriedoutinaccordance
withArticles7and8;
3) theprovisionsofparagraph1 ►M1neednotapply ◄inthecase
of appearance ofa secondary source whichis linked epidemiologi-
cally with a primary source for which samples have already been
taken;
4. the competent authority may extend the measures provided for in
paragraph1toadjoiningholdingsshouldtheirlocation,theirconfig-uration,orcontactswithanimalsfromtheholdingwherethediseasehasbeenrecordedgivereasontosuspectpossiblecontamination.
Article 6
1. In the case of holdings which consist of two or more separate
production units, the competent authority may derogate from therequirements of ►
M1Article 5 (2), first and second indents ◄as
regards healthy production units of a holding which is infected,provided that the official veterinarian has confirmed that the structureand size of these units and the operations carried out there are such
that they are completely separate as regards housing, keeping and
feeding,sothattheviruscannotspreadfromonetoanother.
Thesamemeasuresandthepossibilityofderogatingfromtherequire-
ments of the sixth indent of Article 5 (2) ►
M1 ◄may
be extended to holdings producing milk, provided that, in addition,
milkingineachunitiscarriedoutquiteseparately.
2. Whenrecourseishadtoparagraph1,MemberStatesshallapply
themeasuresspecifiedinCommissionDecision88/397/EEC(1).
3. Itmaybedecided,inaccordancewiththeprocedurelaiddownin
Article 16, that the measures laid down in paragraph 2 shall be
amendedinordertoensurethecoordinationthereofwiththoseadoptedbytheMemberStates.
Article 7
Theepizootiologicalinquiryshalldealwith:
— the length of time during which the foot-and-mouth disease may
haveexistedontheholdingbeforebeingnotifiedorsuspected;1985L0511—EN—01.01.1995—003.001—5
(1) OJNoL189,20.7.1988,p.25.▼M1
▼B
▼M1
▼B
▼B
— the possible origin of the foot-and-mouth disease on the holding
and the identification of other holdings on which there are anmalsofsusceptiblespecieswhichmayhavebecomeinfectedorcontami-
natedfromthesamesource;
— the movement of persons, vehicles and substances referred to in
Article 4 (1), second subparagraph, fifth indent, likely to havecarried the foot-and-mouth virus to or from the holdings in ques-tion.
Article 8
1. (a) Where the official veterinarian finds, or considers on the basis
ofconfirmeddata,thatfoot-and-mouthdiseasecouldhavebeenintroduced fromother holdings on to the holding referred to in
Article 4, or fromthe latter holding on to other holdings as a
result of the movement of persons, animals or vehicles or inany other way, those other holdings shall be placed under offi-cial surveillance in accordance with Article 4 and thissurveillance shall not be lifted until the suspected presence of
foot-and-mouth disease on the holding referred to in Article 4
hasbeenofficiallyruledout;
(b) wheretheofficialveterinarianfinds,orconsidersonthebasisof
confirmed data, that foot-and-mouth disease could have been
introduced ontotheholdingreferred toinArticle 5fromother
holdings as a result of the movement of persons, animals orvehicles or in any other way, those other holdings shall beplacedunderofficialsurveillanceinaccordancewithArticle4;
(c) wheretheofficialveterinarianfinds,orconsidersonthebasisof
confirmed data, that foot-and-mouth disease could have beenintroduced fromtheholdingreferredtoinArticle 5ontootherholdings as a result of the movement of persons, animals orvehiclesorinanyotherway,thoseotherholdingsshallbecome
subjecttotheprovisionsofArticle4.
2. When a holding holding has been subject to the provisions of
paragraph1,thecompetentauthorityshallprohibitremovalofanimalsfromthe holding other than for transport directly to a slaughterhouseunder official supervision for the purpose of emergency slaughterduringa15-dayperiodinthecaseofholdingsreferredtoin1(a)and
(b) and a 21-day period in the case of holdings referred to in 1 (c)
respectively. Prior to granting such authorization, the official veteri-narian must have carried out an examination of the herd andconfirmedthatnoneoftheanimalsissuspectedofbeinginfected.
3. Whereitconsidersthatconditionspermit,thecompetentauthority
may limit the measures provided for in paragraph 1 (a) and (b) to a
part of the holding and the animals contained therein, provided that
the animals there have been housed, kept and fed completely sepa-rately.
Article 9
1. Member States shall ensure that, once the diagnosis of foot-and-
mouth disease has been officially confirmed, the competent authorityestablishes, around the infected holding, a protection zone based on aminimumradiusof3kmandasurveillancezonebasedonaminimum
radius of 10 km. ►
M1The definition of zones shall take account of
natural boundaries, supervision facilities and technological progresswhich make it possible to foresee the possible dispersion of the virusbyair orany other means and will have to be reviewed, ifnecessary,inthelightofsuchelements. ◄
2. (a) Thefollowingmeasuresshallbeappliedintheprotectionzones:
— a census of all the holdings with animals of susceptible
speciesmustbecarriedout;
— holdings which are the subject of such a census must peri-
odicallyundergoaveterinaryinspection;1985L0511—EN—01.01.1995—003.001—6
▼M1
▼B
— themovementofanimalsofsusceptiblespeciesonpublicor
private roads, excluding the service roads of holdings, shallbeprohibited;
— animals of susceptible species may not be removed during
the first 15 days fromthe holding on which they are keptexcept to be transported directly under official supervisionfor the purpose of emergency slaughter to a slaughterhouse
located in that zone or, if that zone has no slaughterhouse
under veterinary supervision, to a slaughterhouse designatedbythecompetent authority.Suchmovement maybeauthor-ized by the competent authority only after examination bythe official veterinarian of all the animals of susceptible
species on the holding has ruled out the presence of
suspectedanimals;
— itinerantserviceforbreedingshallbeprohibited;
— artificial insemination shallbeprohibited duringthe first15
daysexceptwhereitiscarriedoutbythefarmerwithspermthat is on the farmor with spermdelivered directly by aninseminationcentre;
— fairs, markets, shows or other gatherings of susceptible
animals, including collection and distribution, shall beprohibited;
— without prejudice to the case provided for in the second
sentence of the third indent, the transport of animals of
susceptible species shall be prohibited, except for transit bymajorhighwaysormainlinerailways.
(b) themeasuresappliedintheprotectionzoneshallbemaintained
foratleast15daysafter elimination ofalltheanimals referredto in Article 5 fromthe holding and the carrying out on thatholding of preliminary cleaning and disinfection operations in
accordance with Article 10. However, the measures described
in paragraph 3 for the surveillance zone shall remain in forcein the protection zone for the period provided for in paragraph3(b).
3. (a) The following measures shall be applied in the surveillance
zone:
— a census shall be taken of all holdings having animals of
susceptiblespecies;
— the movement of animals of susceptible species on public
roads shall be prohibited except for the purpose of leadingthemtopasture;
— the transport of animals of susceptible species within the
surveillance zoneshallbesubjecttotheauthorization ofthe
competentauthority;
— theanimalsmaynotberemovedfromthesurveillance zone
duringthefirst15days.Betweenthe15thdayandthe30th
day the animals may not be removed from the said zone
except to be transported under official supervision directlyto a slaughterhouse for the purpose of emergency slaughter.Suchtransportmaybeauthorizedbythecompetentauthorityonlyafter theofficial veterinarian hascarried outanexami-nationofalltheanimalsconcernedandconfirmedthatnone
oftheanimalsissuspectedofbeinginfected;
— itinerantserviceforbreedingshallbeprohibited;— fairs, markets, shows and other gatherings of susceptible
animalsshallbeprohibited.
b) Themeasuresinthesurveillancezoneshallbekeptinforcefor
atleast30daysafter theelimination ofalltheanimals referredto in Article 5 fromthe holding and the carrying out on thatholding of preliminary cleaning and disinfection operations inaccordancewithArticle10.1985L0511—EN—01.01.1995—003.001—7
▼B
Article 10
MemberStatesshallensurethat:
— the disinfectants to be used and their concentrations are officially
approvedbythecompetentauthority;
— the cleaning and disinfection operations are carried out under offi-
cial supervision, in accordance with the instructions given by the
officialveterinarian.
Article 11
1. MemberStatesshallensurethat:
— laboratorytestingtodetectthepresenceoffoot-and-mouthdiesease
are carried out by a national laboratory indicated in the►
M1Annex B ◄which may be amended or supplemented in
accordancewiththeprocedurelaiddowninArticle17.Thislabora-
tory testing should, if necessary and especially on the first
appearanceofthedisease,showthetype,sub-typeor,whereappro-priate,thevariantoftherelevantviruswhichmaybeconfirmed,ifnecessary,beareferencelaboratorydesignatedbytheCommunity;
— oneof the national laboratories indicated in ►
M1AnnexB ◄is
responsible forcoordinating standardsandmethods ofdiagnosisineachMemberState;
— the national laboratories referred tointhe first indent liaise witha
referencelaboratorydesignatedbytheCommunity.
2. The Council, acting by a qualified majority on a proposal from
the Commission, shalldesignate, before1January1987,the referencelaboratoryreferredtoinparagraph1andshalldetermineitspowersand
thedetailedrulesforapplyingthesecondindentofparagraph1.
Article 12
MemberStatesshallensurethat:
— when animals of susceptible species are moved out of the holding
on which they are kept, they are identified in such a way as toenable their holding of origin, or the holding fromwhich theyhave come, and their movements to be traced rapidly. However,for certain categories of animals and without prejudice to Article
13 of Council Directive 80/217/EEC of 22 January 1980 introdu-
cing Community measures for the control of classical swinefever(
1), as last amended by Directive 84/645/EEC(2), the compe-
tent authority may, in certain circumstances and having regard tothe health situation, authorize other ways of rapidly tracing their
holding of origin, or the holding fromwhich they have com e, and
their movements. The arrangements for identifying the animals orfortracingtheholdingoforiginshallbedeterminedbythecompe-tentauthority;
— theownerorkeeperoftheanimalsisrequiredtosupplythecompe-
tent authority, on request by that authority, with information
concerninganimalsenteringorleavinghisholding;
— all persons engaged in the transport or marketing of animals of
susceptiblespeciesareabletosupplythecompetent authoritywith
informationconcerningthemovementsofanimalswhichtheyhave
transported or marketed and to furnish all the details concerningsuchinformation.
Article 13
1. MemberStatesshallensurethat:
— theuseoffoot-and-mouthvaccinesisprohibited,1985L0511—EN—01.01.1995—003.001—8
(1) OJNoL47,21.2.1980,p.11.
(2) OJNoL339,27.12.1984,p.33.▼M1
▼M1
— the manipulation of foot-and-mouth virus for research, diagnosis
and/or manufacture of vaccines shall be carried out only inapprovedestablishmentsandlaboratorieslistedinAnnexAandB,
— the storage, supply, distribution and sale of foot-and-mouth
vaccines on the territory of the Community are carried out underofficialcontrol,
— theestablishmentsandlaboratoriesreferredtointhesecondindent
shallbeapprovedonlyiftheyfulfiltheminimumstandardsrecom-
mended by the FAO for laboratories working on foot-and-mouthvirusesin vitroandin vivo.
2. Veterinary experts from the Commission, in collaboration with
the competent authorities of the Member States, shall carry out spot-checks to ascertain whether the security systems applied in the estab-lishments and laboratories referred to in Annexes A and B complywiththeFAO'sminimumstandards.
TheCommissionshallcarryoutthese checksatleast onceayear,the
firstofthesechecksbeingduebefore1January1992,andshallsubmit,also before that date, an initial report to the Standing VeterinaryCommittee. The list of establishments and laboratories in Annexes Aand B may be reviewed in the light of these checks by the Commis-
sion,inaccordance withtheprocedurereferredtoinArticle17,by31
December 1991.Thelistwillberegularly updatedinaccordance withthesameprocedure.
In accordance with the same procedure, a decision may be taken to
adoptauniformcodeofgoodconductforthesecuritysystemsappliedintheestablishmentsandlaboratorieslistedinAnnexesAandB.
3. Notwithstandingtheprovisionsofparagraph1concerningtheuse
of foot-and-mouth disease vaccine, it may be decided, whenfoot-and-
mouth disease hasbeen confirmed and threatens to become extensive,thatemergencyvaccinationusingtechnicalproceduresguaranteeingtheanimals' total immunity may be introduced. In this case, the measurestobetakenshallinclude:
— theextentofthegeographicalareainwhichemergencyvaccination
istobecarriedout,
— thespeciesandtheageoftheanimalstobevaccinated,
— thedurationofthevaccinationcampaign,— aspecificstandstillofvaccinatedanimalsandtheirproducts,
— the special identification and special registration of the vaccinated
animals,
— othermattersappropriatetotheemergencysituation.
Thedecisiontointroduceemergencyvaccinationshallbetakenbythe
Commissionincollaboration withtheMemberStateconcerned,actinginaccordancewiththeprocedurelaiddowninArticle16.Thisdecisionshallhaveparticularregardtothedegreeofconcentrationofanimalsincertainregionsandtheneedtoprotectspecialbreeds.
However, by way of derogation fromthe first subparagraph, the deci-
sion to introduce emergency vaccination around the outbreak may betaken by the Member State concerned following notification to theCommission, provided that basic Community interests are not endan-
gered. This decision shall be immediately reviewed in the Standing
Veterinary Committee in accordance with the procedure laid down inArticle16.
Article 14
1. PendingthesettingupofCommunityreservesoffoot-and-mouth
diseasevaccine,MemberStatesshallbeauthorizedtoretainreservesofantigensinoneoftheestablishmentsreferredtointheAnnexes.
For the purposes of the first subparagraph, contracts between the
Commissionandthoseresponsibleintheestablishmentsdesignatedbythe Member States shall be concluded; the contracts will in particularspecify the quantities of antigen doses necessary, taking account ofthe requirements estimated in the context of the plans referred to in1985L0511—EN—01.01.1995—003.001—9
▼M1
Article 5 (1) of Directive 90/423/EEC(1), for a maximum of 10 sero-
types.
Afterthistransitionalperiod,MemberStatesshallbeauthorizedunder
Communitysupervisiontoretainestablishments forthepackagingandstorageofready-to-usevaccinesforemergencyvaccination.
2. Before 1 April 1991, the Council, acting by a qualfied majority
onaproposalfromtheCommission,shalldesignateaspecializedinsti-tute for vaccine and cross-immunity checks and shall determine itspowers.
3. Before1April1991,theCommissionshallsubmittotheCouncil
a report accompanied, where appropriate, by proposals on the rulesrelating to the packaging, production, distribution and state of thestocks of anti-foot-and-mouth disease vaccines in the Community,together with proposals on the setting up of at least two Community
reservesofanti-foot-and-mouthdiseasevaccines.
Article 16
1. Where the procedure laid downinthisArticle istobe followed,
the matter shall be referred without delay to the Standing Veterinary
Committee set up by Decision 68/361/EEC(2) (hereinafter referred to
as ‘the Committee’) by the committee chairman, either on his owninitiativeorattherequestofaMemberState.
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The Committee shalldeliver itsopinionwithintwodays.Theopinionshallbedelivered by
the majority laid downin Article 148 (2) of the Treaty in the case of
decisionswhichtheCouncilisrequiredtoadoptonaproposalfromtheCommission. The votes of the representatives of the Member Stateswithin the Committee shall be weighted in the manner set out in thatArticle.TheChairmanshallnotvote.
►
A13.◄The Commission shall adopt the measures and shall
implement them immediately, where they are in accordance with the
opinion of the committee. Where they are not in accordance with theopinion of the committee, or if no opinion is delivered, the Commis-sion shall without delay submit to the Council a proposal on themeasurestobetaken.TheCouncilshalladoptthemeasuresbyaquali-
fiedmajority.
IftheCouncilhasnotadoptedanymeasureswithin15daysofthedate
on which the matter is referred to it, the Commission shall adopt theproposed measures and shall implement them immediately unless the
Councilhasvotedagainstthesaidmeasuresbyasimplemajority.
Article 17
1. Where the procedure laid downinthisArticle istobe followed,
the matter shall be referred to the committee without delay by its
chairman, either on his own initiative or at the request of a MemberState.
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The Committee shalldeliveritsopiniononthedraftwithinatimelimitwhichtheChairman
may lay down according to the urgency of the matter. The opinion
shall be delivered bythe majority laid down in Article 148 (2) of theTreaty inthecaseofdecisionswhichtheCouncil isrequired toadopt1985L0511—EN—01.01.1995—003.001—10
(1) OJNoL224,18.8.1990,p.13.
(2) OJNo255,18.10.1968,p.23.▼B
▼A1
▼B
▼A1
▼A1
onaproposalfromtheCommission.Thevotesoftherepresentativesof
the Member States within the Committee shall be weighted in themannersetoutinthatArticle.TheChairmanshallnotvote.
►
A13.◄The Commission shall adopt the measures and shall
implement them immediately, where they are in accordance with theopinion of the committee. Where they are not in accordance with theopinion of the committee, or if no opinion is delivered, the Commis-sion shall without delay submit to the Council a proposal on the
measurestobetaken.TheCouncilshalladoptthemeasuresbyaquali-
fiedmajority.
IftheCouncilhasnotadoptedanymeasureswithinthreemonthsofthe
date onwhichthematter isreferred toit,theCommissionshalladoptthe proposed measures and shall implement them immediately unlesstheCouncilhasvotedagainstthesaidmeasuresbyasimplemajority.
Article 18
OnthebasisofareportfromtheCommissionontheexperiencegained
in the application of this Directive, accompanied by proposals where
appropriate, theCouncilshallreviewthesituation withintwoyearsoftheadoptionofDirective90/423/EEC(
1).
Article 19
Member States shall bringinto force the laws,regulations andadmin-
istrative provisions necessary to comply with this Directive by 1January1987atthelatest.
Article 20
ThisDirectiveisaddressedtotheMemberStates.1985L0511—EN—01.01.1995—003.001—11
(1) OJNoL224,18.8.1990,p.13.▼B
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ANNEXA
COMMERCIALLABORATORIESAUTHORIZEDTO HANDLELIVEFOOT-AND-MOUTH
DISEASEVIRUSFORVACCINEPRODUCTION
Germany: BayerAG,
Osteratherstraße1a,
5000Köln60.
France: Rhône-Merieux,LaboratoireIFFA,
rueMarcelMerieux,
69007Lyon.
Spain: CooperZeltiaSA,
36400Porriño(Pontevedra);
LaboratoriodeSanidadVeterinariaHipra,SA,
LesPrades,
17170Amer(Girona);
LaboratoriosSobrinoSA,
Apartado49,
18080Olot(Girona).
UnitedKingdom: Rhône-Merieux,PirbrightLaboratory,
AshRoad,
Pirbright,Woking,Surrey.
Sweden: Statensveterinärmedicinskaanstalt,Uppsala1985L0511—EN—01.01.1995—003.001—12
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ANNEXB
NATIONAL LABORATORIES AUTHORIZED TO HANDLE LIVE FOOT-AND-MOUTH
DISEASEVIRUS
BelgiumandLuxembourg: Institutnationalderecherchesvétérinaires,
Groeselenberg99,
B-1180Bruxelles.
Denmark: StatensVeterinæreInstitutforVirusforskning,
Lindholm.
Italy: Istituto zooprofilattico sperimentale della Lombardia e
dell'EmiliaRomagna,
Brescia.
UnitedKingdomandIreland: InstituteforAnimalHealth,
Pirbright,Woking,Surrey.
France: Laboratoirenationaldepathologiebovine,
Lyon;
Laboratoirecentralderecherchevétérinaire,
Maisons-Alfort.
Greece: Institute for Foot and Mouth Disease and Exotic
Diseases,
Attiki15310.
Germany: BundesforschungsanstaltfürViruskrankheitenderTiere,
— Anstaltsteil7400Tübingen,
— AnstaltsteilFriedrichLoefflerInstitut,
O-2201—InselRiems.
TheNetherlands: CentraalDiergeneeskundigInstituut,
Lelystad.
Spain: LaboratoriodeAltaSeguridadBiológica(INIA),
28130Madrid.
Austria: Bundesanstalt für Virusseuchenbekämpfung bei Haus-
tieren,Wien-Hetzendorf
Finland: Statens Veterinære Institut for Virusforskning, Lind-
holm,Denmark
Animal Virus Research Institute, Pirbright, Woking,
Surrey,UnitedKingdom
Sweden: Statensveterinärmedicinskaanstalt,Uppsala1985L0511—EN—01.01.1995—003.001—13
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