NoC52/18 OfficialJournaloftheEuropeanCommunities 19.2.94
OpinionontheproposalforaCouncilDirectiveamendingDirective70/524/EECconcerning
additivesinfeedingstuffs (!)
(94/C52/06)
On5August1993,theCouncildecidedtoconsulttheEconomicandSocialCommittee,
underArticles43and198oftheTreatyestablishingtheEuropeanEconomicCommunity,
ontheabovementioned proposal.
TheSectionforAgricultureandFisheries,whichwasresponsibleforpreparingtheCom­
mittee'sworkonthesubject,adopteditsOpinionon8December1993.TheRapporteurwas
MrGardner.
Atits311thPlenarySession(meetingof21December1993),theEconomicandSocial
CommitteeadoptedthefollowingOpinionunanimously .
1.Introduction 2.3.Thisproposalispartofaseriesofactivities
relatingtoadditivescurrentlyunderconsideration by
theCommission .Whenthisproposalispassedthe
Commissionshouldrapidlyaddresstechnicalpoints
andlabellingandissueaconsolidateddocument.This
consolidation mustincludetheclassification in
COM(93)250final.1.1.Thisproposalbuildsontheexperiencegained
sinceDirective70/524/EECwasamendedforthethird
time.Inparticularthereisaneedtoreducetheriskof
poorcopiesofzootechnicaladditivesbeingmarketed
intheCommunity .Infutureitisproposedtolinkthe
authorizationofsuchadditivestothepersonrespon­
siblefortheirmarketing.
1.2.Tofacilitatethis,authorizedadditiveswillbe
dividedintotwocategories.Thefirstknownas'generic'
aredefinedintheproposalasthosewhicharewidely
usedandpresentnoparticulardangers.Thesecond
categorycontainsthoseadditiveswhicharedescribed
as'high-tech'additivesandaredefinedasof'very
specificcompositionforwhichthepersonorbody
responsibleformarketingmustreceiveauthorization in
ordertoavoidthemarketingofcopieswhichmightnot
beinconformityandmightthereforebeunsafe'.3.Specificcomments
3.1.TheCommitteeagreeswiththegeneralthrust
oftheproposalwhilerequiringthefollowingdetailed
changes:
3.2.Article4
ThisArticledealswiththefeetobechargedforthe
examination ofthedossiersforanadditive.TheCom­
mitteeunderstandsthatatpresentsomeMemberStates
chargeafeefortheworktheydo,othersdonot.The
CommitteesupportstheintentionoftheCommission
toestablishauniformfeestructure.However,theCom­
mitteeurgestheCommissiontoensurethattheinitial
feeissetnohigherthantheaverageofthefeescurrently
leviedbytheMemberStates,andthatsubsequent
increasesarekepttotheminimum.
3.3.Article72.Generalcomments
2.1.TheCommitteewelcomestheproposalbecause
itwillhelpensurethatonlyhighqualityadditivesare
availableonthemarket,andassistintheexclusionof
unauthorized copies.Becauseofthis,theCommittee
urgestheCommissiontoproceedrapidlywiththis
timelyproposal.Theseparationoftheadditivesinto
genericandhigh-techcategoriesisalsoconsidered
appropriate .
2.2.TheCommitteebelievesthatthecurrentpro­
ceduresassociatedwiththeauthorization oftheaddi­
tiveslistedinAnnexIImayvaryfromoneMember
Statetoanotherandthusdistortcompetition .The
Committeethereforestressestheneed—alreadyident­
ifiedbytheCommission—toeliminatetheoptionof
nationalauthorization foralladditives,andtointro­
ducea'Communityauthorization 'thatwillensurethat
theprovisionsareappliedconsistentlyanduniformly
inallMemberStates.Article7(2)(a)requiresthatMemberStatesundertake
validationofthedossiertoensurethatitcomplieswith
Article3(3).Inadditiontheyarerequiredtoevaluate
itsconformance totheconditionslaiddownin
Article8.Partofthislatterworkislikelytoberepeated
bytheStandingCommitteeforFeedingstuffswhenthey
assesswhetherornotanadditivemeetstherequire­
mentsofArticle8.TheCommitteeunderstandsthatthe
Commissionintendstheresponsibilityforthescientific
evaluationofadossiertolieprimarilywiththeStanding
CommitteeforFeedingstuffs .Inordertoencouragethe
efficientreviewofdossiersbyMemberStates,thetime
permittedforthisinArticle7(2)(a)shouldbereduced
fromoneyeartosixmonths. HOJNoC218,12.8.1993,p.6.

19.2.94 OfficialJournaloftheEuropeanCommunities NoC52/19
3.4.Article9 thereisneedtoconductadditionalstudiesrequested
byaMemberState,theCommissionortheStanding
CommitteeforFeedingstuffsthetimeallowedmaybe
inadequate .Article9(a)(2)shouldthereforebeamended
toread:
'Provisionalauthorization asreferredtoinpara­
graph1shallbeforthreeyears.Thismaybe
extendedbyuptoafurthertwoyearsifadditional
studiesarecalledfor,whichcouldnothavebeen
foreseenatthecommencement oftheprovisional
marketingphase.'
3.8.Article9(g)Article9indicatesthatadditivesreferredtoin
Article2(b)aretobeauthorizedfortenyears,providing
theycontinuetomeetthesafetyetc.requirements in
Article8oftheproposal.Theholdershouldapplyfor
renewalatleastoneyearbeforetheexpirydate.Inthe
eventthataMemberState,theCommissionorthe
StandingCommitteeforFeedingstuffs requires
additionalstudies,thetenyearauthorizationperiod
mayexpirebeforetheworkiscomplete.Ifthishappens
theCommissionshouldgivetemporaryauthorization
totheadditive,providingtherequirementsofArticle
8(b)and(e)aremet,i.e.therearenohealthrisks.
3.4.1.Topermitthis,thefollowingsentenceshould
beaddedattheendofArticle9(1):
'Temporaryauthorizationofanadditivewherethe
dossierisunderreview,andhasbeenneither
acceptedorrefused,shallbeprovidedaftertheten
yearperiod,subjecttotheconditionsofArticle8(b)
and(e).'
3.4.2.ItisofcourseclearfromArticle9Lthatauth­
orizationcanbewithdrawnatanytimeiftheconditions
inArticle8arenolongermet.Theauthorizationofalltheusesofanadditivemay
nothavebeengivenatthesametime.Forexample,if
itispermittedinseveralspecies,theapprovalforeach
mayhavebeengivenondifferentoccasions.InArticle
9(g)referenceismadetothetransitionalarrangements
foradditivesincludedin(theformer)AnnexII.To
clarifythatthisreferstothefinaldateofauthorization ,
ratherthananyother,inArticles9(g)(1)and9(g)(2)the
words'periodofinclusion'shouldbealteredto'period
fromthelastdateofinclusionforthatspecies'.
3.9.Article9(j)(l)
3.5.Articles9(a)—9(s)
Thesearegivenas9firstto9twentiethinseveral
languageversionsoftheproposal.Itwouldhelpifthe
nomenclature wereharmonized .
3.6.Article9(a)(1)Thisprovidesforthepossibilitythatprovisionmaybe
madetoallowadditivestobeadministeredbyamethod
otherthanincorporation inthefeedingstuff .Itisclear
thatconsiderable carewillbeneededtoensurethat
administration byanyotherrouteiscarriedoutprop­
erly.Theprovisionsrequiredforeachmethodofadmin­
istrationneedtobecarefullydefined.Inordertofacili­
tatethistheCommitteesuggeststhatthewordingof
thelastsentenceofArticle9(j)(l)bealteredinlinewith
the13thpreambletoread:
'Unlessprovisionismadeforthemtobeadminis­
teredbyanothermethod,forwhichtheappropriate
conditionsofusearelaiddown,suchadditivesmay
beusedonlyifincorporatedintofeedingstuffs .The
threegroupsofadditives—growthpromoters,
antibioticsandcoccidiostats—maybeusedonly
inmixedfeedingstuffsandpremixtures.'Toclarifytheintention,intheEnglishversionthethird
lineshouldbealteredtoread:
'....providedthattheconditionslaiddownin
Article8(b),(c)and(e)aremet....'
3.7.Article9(a)(2)
Thisprovidesthatprovisionalauthorization ofhigh
techadditivesmaynotexceedthreeyears.Forthese,if
DoneatBrussels,21December1993.
TheChairman
oftheEconomicandSocialCommittee
SusanneTIEMANN