ARCHIVESHISTORIQUES
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DOCUMENTS "COM"
COM(80)464
Vol.1980/0160

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(80)464 final
Brussels-25July1980
Proposalfora
COUNCILDIRECTIVE
amendingtheannexestoCouncilDirective70/524/EEC
concerningadditivesinfeedingstuff s
(submittedtotheCouncilbytheCommission )
C0M(80)464final

EXPLANATORY MEMORANDUM
1.Jheuseofadditivesinanimalfeedingstuffshasbeenregulatedinthe
Communitysince23November1970byCouncilDirective70/524/EEC(1).
Stfhcethen/onlysubstancesauthorisedbytheabovedirectivemaybe
•»incorporatedinanimalfeedingstuffs.Twotypesofauthorisations are
providedfor,dependingontheleveloftheguaranteesofferedbythe
additive.AnnexIsetsoutthelistofadditiveswhichhavesatisfiedall
i , .
therequirements containedintheDirectiveandwhich,therefore,maybe
4 - '','"
freelyusedthroughouttheCommunity;annexIIliststheadditiveswhich
havenotyetbeenstudiedcompletelybutwhich,asregardharmlessness,
nevertheless offersufficientguaranteesforMemberStatestobeallowed
toauthorisethemnationallyforalimitedperiod.
AsinotherareaswhereCommunitylegislationiscloselylinkedtothe
constantadvanceofscientificandtechnicalknowledge,theCouncilentrusted
•f ■
theCommissionwiththetaskofmakingthenecessaryamendmentstothe
AnnexestotheDirective.Theprocedurefollowedforthispurposeprovides ,
fortheintervention oftheStandingCommitteeforFeedingstuffs andthe
adoptionbytheCommissionofanyamendmenttotheAnnexestotheDirective
isthereforesubjecttoafavourableopinionbytheCommittee.Intheevent
ofacontraryopinionorintheabsenceofanopiniontheCommissioncan
*
requesttheCounciltoactonthemeasureswhichitconsidersitmusttake.
TheCouncilthendecidesbyaqualifiedmajofiry.However,ifattheexpiry
ofaperiod6f3months,theCouncilhasnottakenadecision,theCommission
mayadoptthemeasuresproposediftheCouncilhasnottakenadecisionby
asimplemajorityagainstthosemeasures, -
CD0JNoL270,14.12.1970,p.1

Asitwasanxioustoprovideitselfwithallthenecessaryscientific
guarantees,theCommission,on2December1976,setuptheScientific
fpmmitteeforAnimalNutrition(1)whichitconsultsonalldraftmeasures
Winchmayhaverepercussions onanimalhealthand,inconsequence,onhuman
health.Indraftingsuchmeasures,greatimportanceisattachedtothe
opinionsoftheScientific Committee.
On27June1980theStandingCommitteeforFeedingstuffs didnotdeliver ,
anopiniononadraftDirectiveprolonging by1yearthetemporaryauthori­
sationconcerningthreeadditiveswhichmaybeusednationallyinanimal
feeduntil30dune1981.
Thesamesituvtionaroseinthecaseofapreviousprolongation and,inthe
absenceofanopinionbytheStandingCommitteeandofaCouncilDecision,
theCommissionfinallydecidedtopcolongtheauthorisation fortheuseof
theadditiveinquestion. ' >■.'
Atthevoteon27June1980-therepresentatives oftheFederalRepublicof
GermanyandofItalypronouncedthemselvesagainstthedraftmeasuressubmitted
bytheCommissiondepartments,considering,Sstheyhavedoneinthepast,that
theadditivesinquestionweremedic-inesandthat,assuch,theiruseas
animalfeedhadLittleeffectonanimalgrowthbutinvolved,ontheotherhand,
certainrisks. .
IntheabsenceofanopinionbytheCommittee,theCouncilmustdecidewhether
theCommissionproposals,withregardtowhichtheMemberStateshaveexpressed
afavourableopinionarejustified.Foritspart,theCommissionconsidersthat
theprolongations envisagedareinaccordancewiththerulesandprinciples
whichhavealwaysbeenobservedfortheexamination andauthorisation of
additivesallowedatnationallevel.
(2)0JK'oL279,9.10.'935

-3-
The three additives concerned have been allowed forspecific uses in
annex IItothe Directive onaccount oftheir favourable effects onanimal
growth orontheprevention ofdiseases incertain animal species andof
t^eabsence ofobserved effects likely toentail ,intherecommended condi­
tions ofuse,risks foranimal orhuman health .However ,subsequent examina­
tion ofthese uses has revealed the'need tohave available further information
*
in'order tobeable totake adecision astotheir possible authorisation at
Community level .Ontheother hand ,since'the Italian authorities have informed
therelevant Commission departments that they have tohand the resuls ofa
recent study ontwooftheadditives inquestion ,thegovernment experts arid
theScientific Committee should beenabled totake cognisance ofthis new
information and toseewhether there isaneed torevise their judgement .
However ,interms ofprinciples ,thenon renewal ofauthorisations ,prior to
completion ofthestudies and intheabsence ofclearly unfavourable 1information ,
would beatvariance with the rules followed hitherto for the formulation of
opinions ontheauthorisation orbanning ofanadditive .Such anattitude would
bearbitrary andwobld constitute anundesirable precedent forthefuture .
Moreover ,thefact that certain Member States' feel itnecessary torestrict ;
theuseofthese additives toveterinary medicine threatens tohave opposite
effects tothegoal pursued bytheCommunity inthearea oftheprotection
ofanimal orhuman health .Given that ,where they are nottotally lacking ,
national rules show great disparities with regard tothe issue ofmedicated
feedingstuf fs,itappears tobefarpreferable tomaintain forthemoment the
substances inquestion under thecontrol ofthelegislation governing additives
foranimal feed .Inaddition ,several Member States emphasized that this
tendency toconsider asmedicines substances constantly used bythebreeder
toprevent ?ooddeficiencies orillnesses existirtg endemically ,will lead the
breeder toobtain those substances bydevious means which aredifficult to
control ,"j ■■■.•

-4-
3..-FortheabovereasonstheCommission considersthatitisimperative that
theCouncilshouldactonitsproposaltoprolongtheauthorisation ofuse
J . .|orlincomycin,dimetr^dazole andronidazolependingthecompletionofthe
currentstudies.
"it■ ■ V
i

HECOUNCIL OfTHEfcUftO^SAN COMMUNITIES,
HavingregardtotheTreatyestablishing theEuropeanEconomicCommunity,
HavingregardtoCouncilDirective 70/524/EECof23November1970concerning
additivesinfeedingstuf fs(1),aslastamendedbythethirtyfourthCommission
Directive andinparticularArticle6andArticle16b(4)thereof,-
HavingregardtotheproposalfromtheCommission,
WhereasDirective 70/524/EECprovidesthattheAnnexesmust
beconstantly adaptedinlinewiththeprogressofscientific andtechnical
knowledge;
Whereasconditions ofuseoftheantibiotic "Lincomycin"andthecoccidiostats
"Dimetridazole andRonidazole"atpresentinAnnexIIrequireadditional
examination;whereastheirauthorization shouldtherefore beextendedforalimited
periodwhilstawaitingtheoutcomeofthesestudies;
WhereasintheabsenceofanopinionoftheStandingCommitteeforFeedingstuf fs
theCommission hasnotbeenabletoadopttheenvisagedmeasuresinaccordance
withtheprovisionsofthe-procedurelaidcbwninArticle16boftheabovementioned
Directive;
HASADOPTEDTHISDIRECTIVE :
(1)0JNoL270,14.12.1970,p.1
(2)0JNoLnotpublished

Article 1
InAnnexIIofDirective70/524/EEC
1.inPartA"Antibiotics","30June1980'inthe"Periodofauthorisation"
columnisreplacedby"30June1981"foritemNo17"Lincomycin",
2.inPartB"Coccidiostatsandothermedicinalsubstances","30June1980'
inthe'Periodofauthorisation "columnisreplacedby"30June1981"forthe
followingitems:
No2Dimetridazole
No12Ronidazole
Article2
ThisDirectiveisaddressedtotheMemberStates.