NoL382/228 OfficialJournaloftheEuropeanCommunities 31.12.85
COUNCILDIRECTIVE
of31December1985
prohibitingtheuseinlivestockfarmingofcertainsubstanceshavingahormonalaction
(85/649/EEC)
THECOUNCILOFTHEEUROPEAN
COMMUNITIES ,Whereastheuseofhormonalsubstancesforfattening
purposesshouldthereforebeprohibited;whereasthe
useofcertainsubstancesfortherapeuticpurposesmay
beauthorizedbutmustbestrictlycontrolledinorder
topreventanymistfseofthem;HavingregardtotheTreatyestablishingtheEuropean
EconomicCommunity,andinparticularArticle43
thereof,
HavingregardtotheproposalfromtheCommission ,
HavingregardtotheopinionoftheEuropeanParlia­
ment(!),Whereas,furthermore ,sinceitwouldbedifficulttobe
certainofcorrectoperationoftheschemeasawhole
ifanimalssotreatedandthemeatfromsuchanimals
weretobetraded,thisshouldasageneralrulebe
prohibited;whereas,however,derogationsfromthis
rulemaybeallowedwheresatisfactoryguaranteescan
beprovided;
Whereasaspartoftheadoptionofharmonizedrules
intheCommunityarrangementsforimportationfrom
thirdcountriesthatofferequivalentguaranteesshould
beintroduced ;whereastheseguaranteescanbe
requiredunderDirectives72/462/EEC(3)and
85/358/EEC(4);HavingregardtotheopinionoftheEconomicand
SocialCommittee(2),
Whereastheadministration tofarmanimalsofcertain
substanceshavingahormonalactionisatpresent
regulatedindifferentwaysintheMemberStates;
whereaswhiletheirimmediateeffectonanimalsfrom
thefarmer'spointofviewisclear,assessmentsoftheii:
effectonhumanhealthvaryandthisisreflectedin
theregulationsgoverningtheiruse;whereasthisdiver­
gencedistortstheconditionsofcompetitioninpro¬
ductsthatarethesubjectofcommonmarketorganiza ¬
tionsandisaseriousbarriertointra-Community
trade;
Whereasthesedistortionsofcompetitionandbarriers
totrade,mustthereforeberemovedbyensuringthat
allconsumersareabletobuytheproductsinquestion
underlargelyidenticalconditionsofsupplyandthat
theseproductscorrespondtotheiranxietiesand
expectationsinthebestpossiblemanner;whereas
suchacourseofactionisboundtobringaboutan
increaseinconsumptionoftheproductinquestion;Whereasinordertoensurethattheprovisionsofthis
Directivecanbeimplemented effectivelythelatest
dateforintroductionoftheprovisionsofDirective
85/358/EECshouldbemadetofallbeforethatfor
introductionoftheprovisionsofthisDirective;whe­
reasCommunitycontrolmeasuresshouldensureuni­
formapplicationinallMemberStatesoftherules
applicableonadministration ofsubstanceshavinga
hormonalorthyrostaticaction,
(»)OJNoC288,11.11.1985,p.158.
(2)OJNoC44,15.2.1985,p.14.(3)OJNoL302,31.12.1972,p.28.
(4)OJNoL191,23.7.1985,p.46.

31.12.85 OfficialJournaloftheEuropeanCommunities NoL382/229
HASADOPTEDTHISDIRECTIVE :
Article1
Forthepurposesofimplementation ofthisDirective
thedefinitionsotmeatsandoffarmanimalsgivenin
Article1ofDirective81/602/EEC(*)shallapply.
Forthepurposesofimplementation ofthisDirective
andofDirective81/602/EEC'therapeutictreatment'
shallmeantheadministering toanindividualfarm
animalofanyofthesubstancesauthorizedin
Article3ofthisDirectivetotreatafertilityproblem
diagnosed,onexamination ,byaveterinarian .Such
therapeutictreatmentshallbeprohibitedforanimals
intendedforfattening.Pendingthedecisionsreferredtointhefirstsub­
paragraph,productswhichhavealreadyreceived
authorization tobeplacedonthemarketshall
continuetobeauthorized .
Productsauthorizedpursuanttotheaboveprovi­
sionsshallbesubjecttotherulesofArticles24to
50ofDirective81/851/EEC,withtheexceptionof
thosewhichrelatetonationalmarketingauthori­
zations;
(b)productsusedfortherapeutictreatmentmaybe
administeredonlybyaveterinarian ,intheform
ofaninjection—totheexclusionofimplantation
—tofarmanimalswhichhavebeenclearlyidenti­
fied.
Treatmentofidentifiedanimalsmustberegistered
bytheveterinarian .Ananimalwhichhasbeen
treatedmaynotbeslaughteredbeforeexpiryof
theperiodfixedpursuanttotheprovisionssetout
in(a);
(c)anydecisiononthepossibleinclusioninthe
groupofsubstancesreferredtoinArticle2ofany
newsubstancehavingadirectorindirectoestro­
genic,androgenicorgestagenicactionshallbe
takenbytheCouncilactingonaproposalfrom
theCommission inaccordancewiththevoting
procedurelaiddowninArticle43(2)oftheTreaty.
Anynewsubstancemust,inordertobeabletobe
subjecttosuchadecision,satisfytherelevant
principlesandcriteriaofDirectives81/851/EEC
and81/852/EEC.Article2
WithoutprejudicetoArticle4ofDirective81/602/
EEC,MemberStatesmaynotauthorizeanyderoga­
tionfromArticle2ofthesaidDirective.However,the
administering tofarmanimalsfortherapeuticpur­
posesofoestradiol-17-P,testosteroneandprogeste­
roneandthosederivativeswhichreadilyyieldthe
parentcompoundonhydrolysisafterabsorptionat
thesiteofapplicationmaybeauthorized.
Article4Article3
Forthepurposesofimplementation ofthisDirective:
(a)thereshallbeestablished,aftertheCommitteefor
VeterinaryMedicinalProductshasgivenitsopin­
iononthemeasuresprovidedforinthefirsttwo
indents,andinaccordancewiththeprocedurelaid
downinArticle8:
—alistoftheproductscontainingasactive
substances thesubstances referredtoin
Article2andsatisfyingtherelevantprinciples
andcriteriaofDirective81/851/EEC(2)and
81/852/EEC(3)thatmaybeauthorizedbythe
MemberStates,
—theconditionsofuseoftheseproducts,in
particularthewaitingperiodnecessaryand
detailedprovisionsconcerningthecontrolof
theseconditionsofuse,
—themeansofidentification ofanimals.TheMemberStatesshallprescribethatundertakings
producingsubstanceshavingathyrostatic,©estro­
genic,androgenicorgestagenicactionandthoseauth­
orizedforwhateverpurposetomarketthosesubstan­
ces,andundertakingsproducingpharmaceutical and
veterinaryproductsbasedonthosesubstances,must
_keeparegisterdetailing,inchronologicalorder,quan­
titiesproducedoracquiredandthosesoldorusedfor
theproductionofpharmaceutical andveterinarypro­
ducts.
Article5
MemberStatesmustensure,thatnoanimalsare
dispatchedfromtheirterritorytothatofanother
MemberStatewhichhavehadadministered tothem
inanywaywhatsoeversubstanceswithathyro­(0OJNoL222,7.8.1981,p.32.
(2)OJNoL317,6.11.1981,p.1.
(3)OJNoL317,6.11.1981,p.16.

NoL382/230 OfficialJournaloftheEuropeanCommunities 31.12.85
7.Inaccordancewiththeprocedurelaiddownin
Article8,acontrolprogrammeshallbedrawnup
regardingimportsfromthirdcountries,toensurethat
importsdonotreceivemorefavourabletreatment
thanCommunityproducts.
Withregardtoroutineinspections,thisprogramme :
—willestablishthefrequencyofcontrolsonimports
fromeachthirdcountry,
—willtakeaccountoftheguaranteesofferedbythe
inspectionregulationsofthirdcountries.
Intheeventofpositiveresults,importsfromthird
countrieswillbesubjecttosystematicinspectionsuntil
thesituationisre-established .static,oestrogenic,androgenicorgestagenicaction,
andthatnomeatfromsuchanimalsisdispatched .
TheyshallreservetheCommunitystampformeat
fromuntreatedanimals.
Witheffectfromthedateofnotificationofthis
Directiveanduntilthemeasuresadoptedpursuantto
Articles2and6areapplicable :
—nationalprovisionsgoverningproduceintended
forMemberStates'domesticmarketsshallnotbe
affected,
—MemberStateswhichprohibittheuseofthesub­
stancesreferredtoinArticle5ofDirective
81/602/EECforfatteningmayrestrictentryinto
theirterritorytountreatedfatteninganimalsand
meatfromuntreatedfatteninganimals.
Article7
Article6
TheCouncil,actingbyaqualifiedmajorityona
proposalfromtheCommission ,mayadoptderoga­
tionsfromArticles5and6inrespectoftradein
animalsintendedforreproductionandreproductive
animalsattheendoftheircareerwhich,inthecourse
oftheirexistence,havebeentreatedundertheprovi­
sionsofArticle4ofDirective81/602/EECandin
respectofmeatfromthesevariousanimals,taking
intoaccounttheguaranteesgiven.
Article81.MemberStatesshallprohibitimportationfrom
thirdcountriesofanimalsandofmeatfromanimals
towhichhavebeenadministeredinanywaywhatsoe­
versubstanceswithathyrostatic,oestrogenic,andro­
genicorgestagenicaction.
2.Tothisendthedecisionstobetakenforimple­
mentationofDirective72/462/EEC,takingaccount
ofArticle13ofDirective85/358/EECinthecaseof
meat,andoftheequivalentguaranteeinthecaseof
liveanimals,mustbeadoptedbefore1January1988.
3.MemberStatesshallensurethatimportedfresh
meatcomingfromapprovedslaughterhouses inthird
countriesinrespectofwhichadecisionwithinthe
meaningofparagraph2hasbeentakenis,without
prejudicetoanimalhealthmeasures,circulatedinthe
CommunityinaccordancewithArticle25ofDirective
72/462/EEC.
4.Nationalrulesonsubstanceswithahormonal
actiondealingwithimportsfromthirdcountriesshall
remainapplicable,withdueregardforthegeneral
provisionsoftheTreaty,untileachofthedecisions
referredtoinparagraph2comesintoforce.
5.Asfrom1January1988,MemberStatesshall
suspendimportscomingfromthirdcountriesinres­
pectofwhichnodecisionwithinthemeaningof
paragraph2hasbeentaken.
6.Forthepurposesofapplicationofparagraphs 1
to5,theCommissionshalldrawupalistofthe
productsauthorizedbythirdcountriesforthethera­
peutictreatmentsreferredtoinArticle4ofDirective
81/602/EEC.1.WheretheprocedurelaiddowninthisArticleis
tobeused,mattersshallwithoutdelaybereferredby
theChairman,eitheronhisowninitiativeoratthe
requestofaMemberState,totheStandingVeterinary
Committee(hereinaftercalled'theCommitee')setup
bytheCouncilDecisionof15October1968.
2.Therepresentative oftheCommissionshallsub­
mittotheCommitteeadraftofthemeasurestobe
adopted.TheCommitteeshalldeliveritsopinionon
thedraftwithinatimelimitwhichtheChairmanmay
laydownaccordingtotheurgencyofthematter.The
opinionshallbedeliveredbyamajorityof54votes,
thevotesoftheMemberStatesbeingweightedas
providedforinArticle148(2)oftheTreaty.The
Chairmanshallnotvote.
3.TheCommissionshalladoptthemeasuresand
implementthemimmediatelywheretheyareinaccor­
dancewiththeopinionoftheCommittee .Wherethey
arenotinaccordancewiththeopinionoftheCom­
mitteeorifnoopinionisdelivered,theCommission
shallimmediately submittotheCouncila

31.12.85 OfficialJournaloftheEuropeanCommunities NoL382/231
proposalonthemeasurestobetaken.TheCouncil
shallactbyaqualifiedmajority.
Ifwithinthreemonthsofthedateonwhichamatter
wasreferredtoittheCouncilhasnotadoptedany
measures,theCommissionshalladopttheproposed
measuresandimplementthemimmediately ,save
wheretheCouncilhasdecidedagainstthemeasures
byasimplemajority.Article10
MemberStatesshallbringintoforcethelaws,regula­
tionsandadministrative provisionsnecessarytocom­
ply;
—withDirective85/358/EEC,by1January1987at
thelatest;
—withthisDirective,by1January1988atthelatest.
TheyshallimmediatelyinformtheCommissionthe­
reof.
Article11
ThisDirectiveisaddressedtotheMemberStates.
DoneatBrussels,31December1985.Article9
Themeasuresnecessarytoensurethetransitiontothe
finalarrangements extendingthebanlaiddownin
Article2todomesticproductionmaybeadoptedin
accordancewiththeprocedurelaiddowninArticle.8
duringamaximumperiodafoneyear.FortheCouncil
ThePresident
R.STEICHEN