ARCHIVES HISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(80)614
Vol.1980/0193

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(80)614 final
Brussels,31stOctober1980
PROPOSAL FORACOUNCILREGULATION (EEC)
CONCERNING THEUSEOFSUBSTANCES WITHAHORMONAL ACTIONAND
THOSEHAVINGATHYROSTATIC ACTIONINDOMESTIC ANIMALS
K'..
iv
(presented bytheCommission totheCouncil)
/
C0M(80)614final

EXPLANATORY NOTE
Atitsmeetingof30thSeptember
!
theCouncilinvitedtheCommissiontosubmiturgentproposalsconcerningsubstances
withhormonaleffectinanimalproductionfollowingitsrecentfavourable
orientation :
-envisagingtheprohibition oftheuseofallhormonalsubstancesforrearing
animalsandinconsequencetheirpresenceinmeatproducedorimportedintothe
Community, .
-recognising thenecessitytoacceleratetheworkofharmonisationinthis
.field,inordertoprovideuniformandreinforcedcontrolsnotonlyatthe
levelofthefinalproduct(byfixinglevelsforresiduesandmethodsof
analysis)butalsoupstreamatthelevelofproductionanddistribution of
hormones (rulesconcerningdistribution ofveterinarymedicines)andat
theplaceoflivestockrearingandattheabattoirs.
TheCommission hasexaminedthesubjectoftheuseofhormonesinanimal
production,thepresenceofthesesubstancesinmeatandmeatproducts,their ,
possibleeffectsonhumanhealthandthequalityoftheproducts0This
' •Jexamination hasincludedbothnaturalandartificial hormones­
*
TheCommissionconsidersthatrapidactionmustbetakentoprohibittheuseof
thesesubstancesforrearinganimals„Thisisnecessaryinparticularin
respectoftheartificialsubstances inviewoftheeffectsofthesesubstances
inrelationtocarcinogenicity ,physiological effectsandmeatquality,.The
latteraspectisalsoimportantasregardsuseofnaturalsubstances "since
physiological effectsmayalsooccurwhenexposuretoexceptional levels
accidentally takesplace.Theneedforcontrolis.obvious*

-2-
■AlthoughMemberStatesalreadyhavenationalmeasuresinforce,.itisclearthat
nocentre .IsystemwUlb<sfullyeffssetiv*unUisit1sei#v<elep8risr4an
aCommunitybasis',,"Theserulesareneededsothattradeofanimalsandfresh
meatcanflowunimpededwithintheCommunity ,, r.,
Thesecontrolsneedtobe,'appliedatthelevel,ofdistribution oftheproducts,,
attheleveloftheplaceofproductioninrespectoflivestock,'andatthe•
abbatoirsproducingfreshmeatw-Asregardstheproductionanddistribution of^
hormonesexistinginitiativesatCommunitylevelmustbecompletedandwhere
necessaryextended,.TheCommissionrecallsthatitmade"aproposalinrespectof
-veterinarymedicinesin1976.Asa_resultofdiscussionofthisproposal,theCommis­
sionconsidersthatitshouldals'oincludeaNprovisionthat•hormonal -'substances
whichcanbeusedinthepreparationof"veterinarymedidoes'shouldbesupplied
\ ,
■onlytoauthorisedpersons;-.TheCommissionurgestheCounciltoresolvethisquestion
and|takeanearlydecision*
-ArelatedinitiativewhichtheCommissionis-urgentlyconsidering "concernsa"
draft,proposal -onmedicated .feedingstuffs BIt-isalreadynecessary^howeverr
'toprovideforcontrolsonthedistribution anduseofhormonesforveterinary
therapeuticpurposes*/ ,
•To*suppoftthisprimarycontrol,,-measuresmustbeadoptedtofflon'itorlive,animals^
on'thefarmforillicituseofthesesubstances „.-Thisaction -wi11need
approoriatesamplingprocedures ..'adopted -to.thedifferentanimalcategories ,-and.
suitablesanctionsincaseofinfringements *, •,
Afurtherstrategicpointwherecontrolmustbeconsideredisattheslaughterhouse
intheformof'screeningfreshmeatforresiduesaspartofthepost-mortem
'examination * •Theextensionofthisexamination -to-ante-mortem
inspectionoftheliveanimaleitherattheslaughterhouse orfarmoforiginwilt,
probably .provide'amore-effective 'control*Inailcasesitisessentialto
•providea;commonregulationforlaboratorymethodswhichmustbeusedforthese
examinations ,,Inaddition,,toenabletracingoftheoriginofanimalswhen
positiveresultsarefound,theestablishment ofasystemtopermitthe ..
identificationofanimalsirvtheCommunityisimportant *.
t

-3-
TheworkalreadydenelaytheCommissioninrespectofthepreBlfmsofeontrol
hasconcentrated particularly onmethodsofanalysis.Goodmethodswhichare
suitablebothqualitatively andquantitatively arenoteasily^developedbut
recentprogressshouldenabletheCommissiontotakeappropriateactionshortly\inthisrespectparticularly asregardsartificialsubstances whichareof
special ,concern.Thisquestionismoredifficultinrespectofnature 1hormones
asthereisalwaysacertainlevelofthesehormonesnaturallypresentinmeat
animals.Inconsequence thedevelopment ofchecksontheuseofthesesubstances
ismoredifficult.
Inordertoavoiddistortionofcompetitionitisnecessarytoprovidefor
theharmonisation ofthemeansoffinancingthesecontrols.Tothiseffec"
provisionisincludedsothatthesecostsmustbebornebytheproductits;Lf.
χ
TheproposaloftheCommissionlaysdoNnthebasisforthesecontrols.
Theintroduction ofabanattheCommunitylevel,andofthenecessarycontrol
measures,willinvolveadditionalcostscfproduction whichm~.yeventuallybe
reflectedinthelongtermonthepriceofmeat.Butatthe^timeconsumers
willbeassuredofbetterprotectionanda'betterqualityprod.,

PROPOSAL
fora
COUNCILREGULATION
concerningtheuseofsubstanceswithahormonal
actionandthosehavingathyrostaticactionin
domesticanimals
.THECOUNCILOFTHEEUROPEAN COMMUNITIES : .
HavingregardtotheTreatyestablishingtheEuropeanEconomi^Communityandin
particularArticle43thereof; ''-.
HavingregardtotheproposalfromtheCommission/ 5 '
HavingregardtotheOpinionoftheEuropeanParliament/
HavingregardtotheOpinionoftheEconomicandSocialCommittee/
Whereasduetotheresiduesthattheyleaveinmeat,substanceswithahormonal
actionorthyrostaticactionmaybedangeroustohumanhealth;whereasthese
substances mayalsoaffectthequalityofthemeat;
Whereasforthesereasons,theiruseforfatteningpurposesmustbebanned,inthe'
interestoftheconsumer;
Whereas,moreover,iftheuseofnaturalsubstances maybeauthorisedfortherapeutic
purposes,thismustbeatthesametimestrictlycontrolled,bothbythe
establishment ofalistofauthorisedproductsandbytheestablishment ofthe
conditionsunderwhichtheymaybeused;whereastheparticulardangerofartificial
substancesdoesnotpermittheirinclusionunderthisautorisation ;
WhereasthepresentRegulationcallsformeansofapplication inparticular
concerningthefixingoftolerances,frequencyofsamplingandmethodsusedto
detectthepresenceofresidues;

Whereasmeanspermitting theassuranceofaneffectivecontrolofCommunity
provisions andoftheapplication ofthenecessarysanctionsmustbeestablished ;
Whereasitissuitable,inordertoavoiddistortionofcompetition,toprovide
thatthecostsresultingfromthiscontrolmustbebornebytheproductitselfV
inconformitywiththecurrentpracti.eegenerallyfollowedintheCommunity,
HASADOPTEDTHISREGULATION :
Article1
ThisRegulationshallapplytotheuseofsubstanceswithahormonalactionand
thosehavingathyrostatic actionindomesticanimals'andtothepresenceof
residuesofthesesubstancesindomesticanimals,freshmeatandfreshpoultry
meat- -
Article 2
ForthepurposesofthisRegulation thefollowingdefinitions shallapply:
(a)Domesticanimals:animalsofthefollowingspecies:bovine,swine,sheep,
goats,domesticsolipedsandpoultry*
(b)Freshmeat:freshmeatasdefinedinArticle 1ofDirective 64/433/EECandin
Article2ofDirective 72/462/EEC,
(c)Freshpoultrymeat :freshpoultrymeat asdefinedinArticle 1ofDirective
71/118/EEC* , -'"■ ...
(d)Residue:detectablequantitiesofasubstancewithahormonalorthyrostatic
actionandtheirmetabolites * ,
(e)Examination forresidues :theexamination fordetectionofresidues*
(f)Tolerance :themaximumpermittedquantityofresidueindomesticanimalsor
infreshmeat*
(g)Holding:anofficially supervisedagricultural ,industrial orcommercial
undertaking inwhichdomesticanimalsareregularlykept*'

-3-
Article3
Notwithstanding Article4,
(a)Theuseondomesticanimalsofsubstanceswithoestrogenic,
androgenic andgestagenic effectandofsubstances havingathyrostatic
effectisprohibited, <
(b)TheputtingintotradeintheterritoryoftheCommunityofdomesticanimals
andoffreshmeatcontaining residuesinexcessofthetoleranceisprohibited.
Article4
1,Theuseofnaturalhormonalsubstances withactionsoreffectsreferredto•
inArticle3(a)isauthorised totreatdomesticanimalstherapeutically
includingsynchronisation ofoestrusprovidedthat;
-thecompetentauthority hasapprovedtheproductfortherapeutic useandits
conditions ofmanufacture inaccordance withCouncilDirective on
theapproximation ofthelawsofMemberStatesonmedicinalveterinary
.products,andhasspecifiedtheconditionsofuseincluding awithdrawal period
duringwhichthedomesticanimalcannotbedeliveredforslaughter.
-theproductisadministered byaveterinarian ,whoshallkeeparecordofthe
useoftheproduct,includingquantitydateandidentificationofthetreated
domesticanimal, ,
-manufacturers andallhandlersofthesesubstancesshallkeeparecordof
production andsales.
/
2,Additionalprovisions concerning theapplication ofparagraph .1,inparticular -
theestablishment ofaCommunitylistofnaturalhormonalsubstances,shallbe
adoptedbytheCouncilactingbyaqualifiedmajorityonaProposaIfromthe
Commission,Thislistmaybeamendedinaccordance withtheprocedureof
Article9,

-4-¥
Article5
1..Freshmeatputintotrade,intheCommunitymustbesubjecttoexamination
forresiduesofthesubstancesreferredtoinArticle3.
2.However,theexaminationofthefreshmeatmay
bereplacedorsupplemented byanexamination ofthedomesticanimaleither
attheplaceofslaughterorattheholdingoforiginortransit.
3,TheCouncil,actingbyaqualifiedmajorityonProposalfromtheCommission,
\
shalldecidethegeneralrulesfortheapplication ofparagraphs 1and2in
particular:
•-thefrequencyofsampling.
-thetolerances forresidues.
4„Themethodsandproceduresrequiredfordetectingthepresenceofresidues
ofthesubstancesshallbedecidedinaccordancewiththeprocedurelaiddown
inArticle9. -
Article6
DomesticanimalscoveredbythisRegulationmustberegisteredoridentified
topermitinvestigation wherenecessaryattheholdingoforiginortransit,.'
*
Article7
Allcostsforthecontrolsandexaminations providedforinArticle5shallbe
bornebyataxonthe..productattheslaughterhouse withoutreimbursement
frompublicfunds*
Article8 -
MemberStatesshallensurethat,incaseofcontravention ofthepresentRegulation :
~domesticanimalsandfreshmeatconcernedareconfiscated anddestroyed;
-sanctionsareAppliedtoallpersonscontravening thepresentRegulation.

V1
Article9
,\
ThisRegulationshallnotapplytotheuseofsubstancesforthepurposesof
Pfestahshi
Article10
1*.WheretheprocedurelaiddowninthisArticleistobeused,themattershall
bereferredwithoutdelaytotheStandingVeterinaryCommittee(hereinafter
referredtoas'theCommittee 1),setupbytheCouncilDecisionof15October
1968,bythechairman,eitherohhisowninitiativeorattherequestofa
MemberState*
2*WithintheCommittee,thevotesoftheMemberStatesshallbeweightedas
providedinArticle148(2)oftheTreaty*Thechairmanshallnotvote*
3*TheCommissionrepresentative shallsubmitadraftofthemeasurestobe
•adopted*TheCommitteeshalldeliveritsopiniononthemeasureswithina
periodtobedetermined bythechairmaninkeepingwiththeurgencyofthe
questionsubmittedforexamination *Opinionsshallbedeliveredbyamajority
of41votes*
4*TheCommissionshalladoptthemeasuresandshallimplementthemimmediately,'
wheretheyareinaccordancewiththeopinionoftheCommittee,,Wherethey
arenotinaccordancewiththeopinionoftheCommitteeorifnoopinionis
delivered,theCommissionshallwithoutdelaysubmittotheCouncilaproposal
onthemeasurestobeadopted*TheCouncilshalladoptthemeasuresbya
qualifiedmajority*
IftheCouncilhasnotadoptedanymeasureswithinthreemonthsfromthedate
onwhichtheproposalwassubmittedtoit,theCommissionshalladoptthe
proposedmeasuresandapplythemimmediately * .
\Article11
ThisRegulationshallenterintoforceon1January1981.
ThisRegulationshallbebindinginitsentiretyanddirectlyapplicablein
allMemberStates.
\