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Vol.1974/0180

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COMMISSION OFTHEEUEOPMANCOMMUMTIES
COM(74)Holfinal.
Brussels,15July1974
Proposalfora
SecondCouncilDirective
amendingtheDirectiveof23November1970»
concerningadditivesinfeedingstuffs .
(submittedtotheCouncilbytheCommission)
CQM(74)llolfinal.

Justification
TheCouncilDirectiveof23November1970(OJNoL270of14December,1970,
p.l)concerningadditivesinfeedingstuffs hasbeengenerallyregardedasan
importantsteptowardstheharmonisation cflegislation onthissubject.
Directivenotonlyregulatetheuseofadditivesinfeedingstuffs ,but
alsoforthefirsttimeprotectsconsumersintheCommunityagainsttheexcessive
useofadditives .
TiiistendencyhasbeenreinforcedastheDirectivehasbeenapplied.
WhentheoriginalDirectivewasamendedbytheCouncilDirectiveof28April1973
amendingtheDirectiveof23November1970concerningadditivesinfeedingstuffs
(OJNoL124of10May1973,p.17)»and"theprocedureoftheStandingCommittee
onFeedingstuffs wasintroducedtoamendtheAnnexes,theCommissionlostno
timeinseizingtheopportunity ofeliminating anumberofantibiotics from
AnnexI(listofadditiveswhicharetobepermittedthroughouttheCommunity).
Italsoplacedlimitations andconditions ontheuseofanumberofadditives
listedinAnnexII(listofadditiveswhichmaycontinuetobeusedtemporarily
withinindividualstates).
Cntheotherhand,theCommissionfurtherdevelopedtheAnnexeswiththepurpose
ofimprovingtheconditionsforagricultural production .Thisprocesscontinues
anduptothepresent,sincethefirstreformoftheprovisionsoftheDirective
inApril1973therehavebeeneightamendmentstotheAnnexes.Furtheramendments
areinpreparation .
Experiencegainedinthecourseofmakingtheabove-mentioned amendmentshas
shown,however,thatthepresentprocedureisstillnotcompletelysatisfactory .
Accordingtothepresentconcept,whichisexpressedintheDirectiveinforce,
AnnexIwasregardedasbeingtherule.AnnexIIwasonlysetupinorder
tocoverthosesubstances onwhichagreementhadnotbeenreachedwhenthe
Directivewaspassed,butwhichatthetimewerepermittedinatleastone
MemberStatesinaccordancewithprincipleswhiehatleastapproximated to
thoseestoutintheDirective .ThesubstanceslistedinAnnexIIweretobe
atthefreedisposalofindividualstates;however,aMemberStatewhichdid
notmakeuseofthisopportunity would,accordingtoArticle14»havenoright
tobaranimalproductsfromitsmarketonthepretextthatsubstancesfrom
AnnexIIhadbeenaddedinthecountryoforigin.

-2- •
Wewereconcernedherewithmaterialswhichhadbeenwellknownforalongtime,
theuseofwhichhadalreadybeendiscontinued insomeMemberStates,andpartly
withnewmaterials,aboutwhichsomeMemberStatesstillwantedtogather
information .Proceedingontheassumptionthatwithinfiveyearsfollowing
theissueoftheDirectivetotheMemberStates,thissituationwouldhave
resolveditself,theCouncillimitedtheapplicability ofAnnexIIaccordingly.
ThistimelimitrunsoutduringNovember 1975•
Infact,however,AnnexIIhasalreadyproveditsgeneralvalueasaphasing*-
.inandphasing-outcategory.NewmaterialsorusesproposedsincetheDirective
wasissuedhaveinfactalmostwithoutexceptionbeenfirstincludedinAnnexII,
becauseineveryinstancetherewereMemberStateswhichrequiredacertain
periodoftimetomaketheirowntestsonnewmaterialsfromotherMember
States.Contrariwise ,itwaspossibletoeliminateanumberofadditives
fromAnnexIonlybecausetheycouldbegivenacertainphasing-outperiod
byincludingtheminAnnexII. ■''''
/
Thisprocedureisnowtobegeneralised ,inthatatimelimitistobeput
'.ontheavailability tothegovernmentsofMemberStatesofmaterialslisted
inAnnexII.Underthisarrangementthetimelimitapplicabletoproducts
listedatpresentinAnnexII(endof1975)willinpracticeremainunchanged,
whiletimelimitswillinfuturebedeterminedunderStandingCommittee
procedure. ,
SincetherevisionoftheAnnexeshasbeenretardedbytheaccessionofthe
newMemberStates,thefive-yearlimitisalsotobeextendedbythreeyears
duringwhichMemberStatesmaypermittheuseofsubstancesbelongingto
groupsofsubstanceslistedinAnnexIIwhichinpartextendbeyondthose
listedinAnnexI.Careisstilltakentoensureintheprocessthatthis
authorisation doesnotextendtosubstanceshavingahormonaloranti–hormonal
effect.
./•

Itisfurtherimportantthatinfutureforallsubstancescomingwithin
AnnexIIevidencemustalsobeproducedshowingthatthesubstancesarenot
harmful,thattheycanbeanalysedand.thattheyfulfilmedicalandveterinary
requirements .
Furthermore ,theamendingDirectiveshouldeliminateapointofcontention
whichhasarisenconcerningtherangeofapplicability .Infactthemajority
ofMemberStateseitherproceedfromtheassumptionorhaverecognisedthat
theDirectiveappliestothefeedingstuffs ofallanimals.Oneofthenew
MemberStatestakesissuewiththisandforthemomentwishestoapplythe
Directiveonlytoproductiveanimals.
Thereismuchtobesaidfortheusefulnessofthiskindoflimitation,
particularly withregardtopets,e.g.dogs,cats,canariesandornamental .
fish.ForthisreasontheCommissionreservestherighttoreconsiderat
anappropriatetimewhetheraspecialregulationshouldnotbedra.jnupfor
theseanimals,particularly inviewofthefactthatthecompositionof
theirfeedisdifferentfromthatofproductiveanimals.Ontheotherhand,
wildanimals,includingmostofthosekeptinzoos,shouldalreadybeexcluded
fromtheareaofapplicationoftheDirective.
Thefirstamendmentomittedtomakethecriteriaofpuritysubjectto
StandingCommitteeprocedure.Sinceitishereaquestionoftechnicalimple­
mentingmeasuresthisshouldnowbecorrected.Thisprocedureshouldalso
beappliedwhenfixingcriteriaforthecomposition andcharacterofpermitted
substances .
AnumberoffurtheramendmentstotheDirectivearepurelytechnicalinnature,
butmustbereferredtotheCouncil,becausetheyarenotestablishedin
theAnnexes.
TheessentialprovisionsoftheDirectiveshouldbeincorporated innational
legislationby1July1975»BOastoavoidanylegalhiatusresultingfrom
thelapseofthetimelimitforAnnexII.
/•

Thedrafthasbeendiscussedwithrepresentatives orgovernmentsinthe
CommissionWorkingGrouponFeedingstuffs Legislation .•Itwasfoundthat
aconsiderable measureofagreementexistedonquestionsofprinciple.
Professional andconsumerorganisations throughouttheCommunityhavealso
beenconsultedconcerningthedraft.Againitwasfoundthattherewas
considerable agreementinfavourofthedraft.

.Second Council Directive of amending the
Directive of23November 1970 »concerning additives infeedingstuffs
THECOUNCIL OPTHEEUROPEAN COMMUNITIES ,
Having regard totheTreaty establishing theEuropean Economic Community ^
andinparticular Article 43thereof ;
Having regard totheproposal from theCommission ;
Having regard totheOpinion oftheEuropean Parliament ;
V
Whereas during theapplication oftheCouncil Directive of23Novemoer
1970 (1),concerning additives infeedingstuffs ,aslast amended "bythe
T*-* -1-J-1.
^Comelesion Directive of26February 1974 (2),amending theAnnexes
oftheaforesaid Directive ,itappeared necessary todefine theterm
"animal ";
Whereas itisadvisable ,insofarasthis tern relates topets ,
toexamine subsequently ifitwould not beadvisable toadopt aspecial
Directive inthecase offeedingstuffs intended forthese animals ;
Whereas taking account oftheamendments made bytheCommission tothe
Annexes ,itisnecessary tomake some corrections andamendments ofa
technical nature totheprovisions oftheDirective ;
Whereas experience gained inrelation toAnnex II,which lists allthe
additives which maybepermitted byMember States atnational level upto
theendof1975 »hasshown that this Annex must ,henceforth ,actasa
buffer regulating theentry orthedeletion ofadditives permitted atcommunity
level (Annex 1);whereas such ameasure necessitates thelaying down of
special conditions governing theintroduction ofsubstances toAnnex II;
(1)OJNoL270 ,14.12.1970 ,p.1
(2)OJNoL

Whereas ,under Directive (EEC)No73/103oftheCpuncil of28April 1973
(3),theadaptation oftheAnnexes tothegrowth ofscientific and
technical knowledge andhonce theadmission ordeletion ofadditives has
been "brought under theprocedure oftheStanding Committee forFeedingstuf fs;
whereas ,consequently ,itwould beadvisable tospecify likewise the
criteria ofpurity forthese substances inaccordance with this saoe
procedure ,
Whereas ,finally ,itisalso advisable toprovide forthespecification
ofcriteria onthecomposition andquality ofpermitted additives ,
Whereas experience obtained during themarketing offeedingstuffs
containing additives' demonstrates thenecessity toimprove themarking
ofthese feedingstuffs which also include premixtures ,
HAS ADOPTED THIS DIRECTIVE :
Article 1
TheDirective of23November 1970 shall beamended asfollows :
1.Thefollowing subparagraph shall beinserted inArticle 2;
"g)Animals :Theanimals belonging tospecies' which arenormally
kept andnourished byman",
2.Thefollowing text shall besubstituted forthefirst sentence of
Article 3(4)s
"4.Antibiotics (Annex I(A)andAnnex II(A))andgrowth promoters
(Annex I(j)andAnnex II(E))maybemixed with only onesingle
other antibiotic orgrowth promoter ,unless themixture tobe
produced isalready provided forinthose Annexes ".
(3)OJNoL124 ,10.5.1973 ,p.17

Intheintroduction toArticle 3(7)"thewords "except inthecase
ofsubstances E709andE712"shall bedeleted .
InArticle 3(7)(B),thewords "Zincbacitracin andspiramycin ;Virginia my
shall besubstituted for the words "All other antibiotics ".
InArticle 40)(a)>theword "eight "shall besubstituted forthe
word "five ", rrords "inAnnex IorII"shr.ll besubstituted fortheword
Annex I".
InArticle 4(1)(h),thewords "during aperiod offive years
following notification ofthis Directive "shall bedeleted .
Thefollowing text shall besubstituted forthetext ofArticle
61):
"1.Thecriteria concerning thecomposition ,purity endquality
.ofadditives listed inthis Directive shall befxed ,taking
account ofscientific andtechnical knowledge ,inaccordance
with theprocedure laid down inArticle 16(a)".
Thefollowing sentence shall beadded toArticle 6(2)(b):
"Thesubstance maybeinserted inAnnex IIforadetermined period ,
wheniheconditions ofsubparagraph A(b)/S$4Li111satisfied ".
Thefollowing subparagraph shall beadded toArticle 6(2):
"C.Anewsubstance oranewusage attributed toasubstance may
beinserted inAnnex IIonlywhen conditions (b).(c)'and(e)
subparagraph Aaresatisfied and itcanbeassumed ,taking
account ofavailable results ,that theother conditions ofs\\i>»
paragraph Aarealso satisfied ".
Intheintroduction toArticle 90)"thewords "andgrovrth promoters
(Annex I(J))"shall beinserted after thewords "Vitamins D(Annex I(H)
No.1)".

ï
mmAmm '''W/'/v^
11.InArticle9(1)(b),thewords"orgrowthpromoters"shall"be
inserted.
12.InArticle4(1)(C),thefollowingindentshallbeinserted:
forgrowthpromoters,1000ppm".
13.Thefollowingtextshallbesubstitutedforthetextof'Article
10(1)(g):
"g)additivespermittedunderArticle4(1)(c)i(d)and(e):
natureandcontent".
14.InArticle10,thefollowingparagraphshallbeinsertedafter
paragraph2:
"(2a)TheMemberStatesshallprescribethatthenatureofthe
additiveswhichtheyhavepermittedunderArticle40)
(a),(b)and(f)mustbespecifiedonthepackageorlabel.
Theymayprescribethatthecontentmustalsobespecified".
15.InArticle11(i),secondsubparagraph ,thewords"ofAnnexIorII"
shallbesubstiutedforthewords"ofAnnexI".
16.ThefollowingArticleshallbeinsertedafterArticle11:
"Article11a
MemberStatesshallprescribethatpremixtures maynotbeplacedon
themarketunlessthelabelorpackagebearsastatementindicating:
a)thatthepremixtureisnotintendedfordirectanimalconsumption.
b)the-maxiuumpemittodcontentofthepremixtureinthedailyr<~t°n
17.Anewcolumn,entitled"Periodofauthorisation",shallbeaddedto
AnnexII.Thedateof"31December1975"shallbeenteredinthis
columnforalltheadditiveslistedat■present .intheAnnex­
,;(.\'•/,-.:;vb-
•l«/a-y1976.

-5-
Article 2
Member States shall bring into force thelaws ,regulation and
administrative provisions necessary tocomply :
a)by1July 1975 atthelatest with Article 1(9)(6)(7)(8)and
(9);
b)by1July 1976 atthelatest ,with theother provisions ofthis
Directive .
Arti cle 3
This Directive isaddressed tothe Member States .