ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(79)184
Vol.1979/0078

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COMMISSION OFTHEEUROPEAN COMMUNITI
COM(79)184 final
Brussels,10April1979
U-,
V'•'V;
Proposalfora
COUNCILDIRECTIVE
amendingforthesecondtimeDirective 74/329/EEConthe
approximation ofthelawsoftheMemberStatesrelatingto
emulsifiers,stabilizers,thickeners andgellingagents
foruseinfoodstuffs
(submittedtotheCouncilbytheCommission )
C0M(79)184final

EXPLANATORY NOTE
1.TheCouncilDirectiveontheapproximation ofthelawsoftheMember
Statesrelatingtoemulsifiers,stabilizers,thickenersandgelling
agentsforuseinfoodstuffs(74/329/ESC)1(asmodifiedbyCouncil
2Directive78/612/EEC)requiresthatwithinfiveyearsofnotification
oftheDirective,theCommissionshouldexaminethestatusoftwo•
groupsofsubstances :
(a)SubstancespermittedforuseintheCommunitybyvirt-aeofArticle
2.2ofDirective74/329/sSC
Councildecisionshavebeentakenonallthesesubstancesexcept
E460(microcrystalline cellulose).TheCommissionhasnow
completeditsexamination onthissubstanceandproposesthat
E460shouldbesubdividedintomicrocrystalline celluloseand
powderedcellulose.TheScientific CommitteeforPoodhasadvised
thatfromthepointofviewofpublichealththisproposalis
acceptable"^.
(b)SubstancesnotpermittedforuseintheCommunityasawholebut
whichmaybepermittedbyindividual MemberStatesbyvirtueof
Article3ofDirective74/329/SEC
TheCommission askedtheScientific CommitteeforFoodwhetherthe
substancesinthisgroup,andwhicharelistedinAnnexIIofthe
basicDirective,couldbesafelyaddedtoAnnexI,(i.e.substances
whichmaybeauthorisedthroughouttheCommunity).
2.ThepresentproposalimplementstheCommittee'sadvice^by:
1
(a)authorizingcertainforafurtherlimitedperioduntil31December1984
(seetheAnnextotheattachedproposalforDirective)
(b)includingcertaininAnnexIofthebasicDirective(seeArticle
3.2oftheattachedproposalforDirective).Theproposalrecommends
thatQuillaiaextract(E44l)shouldbeauthorizedinsoftdrinks
(andbeveragescontainingsoftdrinks),astheScientificCommittee
forPoodsawnoobjectiononhealthgroundstothisuse.However
astheCommissionispreparingproposalsforCommunitymeasuresonthe

description andcomposition ofsoftdrinks.thepresentproposal
requiresthatS441should "bepermittedonlywherenationallaw
allowsitsuse.Itisenvisagedthatamorecompletedescription
ofthe"conditionsofuse"will"bepossibleonlywhentheCommunity
measuresonsoftdrinksareaccepted.
TheScientific CommitteeforPoodadvisedthatKarayapnmshould "be
subjectedtoanumberofpreliminarytoxicological studieswhich
shouldbepresentedwithinoneyearsothatadecisioncouldbetaken
bytheCommitteeastowhetheritcouldacceptafurthertemporary
approvalofthesubstanceforalongerperiodtoallowmore
extensivetoxicological testingtobecompleted.TheCommission
hasbeeninformedthatthepreliminarytoxicological studiesare
expectedtobeundertaken andthattheresultsofsuchstudies
would"beavailablewithinoneyear.
TheproposalthereforerecommendsthatKarayagumshouldbemaintained
inAnnexIIbutthatthesituationbereviewedbefore31December1980.
(c)deletingthereferencetoGhattigumfromAnnexII.Itisproposed
thatfoodstuffscontainingghattigumcanbemarketeduntilthe
30June1980(Article5).
3.TheCommissionhasalsoreceivedanumberofrequestsforareexamination
ofTragacanth(s413)•TheScientificCommitteeforPoodhasadvised"^
thatthesubstanceshouldbesubjectedtoextensivetoxicological testing
withinfouryearsbutthatinthemeantimeitsuseisacceptable.The
presentproposalrecommendsthatthesituationbereviewedattheendof
1982sothattheScientificCommitteeforPoodcanbeinformedofthe
progressofthestudiesandtoallowtheCommissiontotakeappropriate
actionatanearlystage.
X0JNoL189,12.7.1974,P.1
20JM0L197of22.7.1978.p.22
ScientificCommitteeforPood(SeventhSeries)

Propcr.c.IforaCouncilDirectiveamendingfor"thesecondtime
Directive74/329/EEContheapproximation ofthelawsoftheMemberStates
relatingtoemulsifiers,stabilizers,thickenersandgellingagentsfor
useinfoodstuffs
THECOUNCILOFTHEEUROPEANCOMMUNITIES ,
HavingregardtotheTreatyestablishingtheEuropeanEconomicCommunity,
andinparticularArticle100thereof;
HavingregardtotheproposalfromtheCommission"'':
__.?HavingregardtotheopinionoftheEuropeanParliament ;
HavingregardtotheopinionoftheEconomicandSocialCommittee^;
WhereasDirective74/329/EEC^,aslastamendedbyDirective78/612/EEC"^
laysdownasinglelistofemulsifiers ,stabilizers ,thickenersandgelling
agentswhichmaybeauthorizedforuseinfoodstuffsbytheMember
States;
Whereashavingregardtothemostrecentscientificandtechnicalknowledge
thereferencetomicrocrystalline cellulose(E460)inAnnexItoDirective
78/6I2/EECmustbereworded;andwhereastheuseoftragacanth(E413)
shouldbereevaluatedafteranenquirybytheCommission ;
WhereasAnnexIItoDirective74/329/EECindicatesthedesignationsofthesubstances
whichmaybetemporarilyauthorizedbyMemberStatesforuseinfoodstuffs;
WhereasArticle3,(1) .ofDirective74/329/EECauthorizesthis
derogationforaperiodoffiveyearsfromthedateofnotification oftheDirective;
Whereashavingregardtothemostrecentscientificandtechnicalknowledge
thesaidAnnexIImustberevised;whereas,therefore,forcertainsubstances
periodoftemporaryauthorization mustbeprolongedtopermitthe
completionofcertaintoxicological investigations necessaryinthelight
1CJ7,0
2oj;;0
3OJMo
4OJHoL189,12.7.1974,p.1
5OJïloL197,22.7.1978,p.22

ofpresent-day requirements regarding thesafety oftheir use infoodstuffs ;
Whereas forcertain substances thescientific andtechnical knowledge is
satisfactory thus allowing t.heir transfer toAnnex Itotheabove mentioned
.Directive ;andwhereas ghatti gummust nolonger beused after atemporary
period toallow thesale offoodstuffs containing this substance which are
already 'onthemarket ;
HASADOPTED THIS DIRECTIVE ,
Article 1
*Directive 74/329/SEC .ishereby amended asfollows :
1.Paragraphs 2and 3ofArticle 2arereplaced bythefollowing :
"2.However ,asregards the substances referred toinAnnex Iunder
E413andE440 the Council ,acting inaccordance with theprocedure
provided forinArticle 100oftheTreaty ,maydecide ,by31
December 1982 andafter anenquiry "bytheCommission ,todelete
them from theAnnex orotherwise change their status ."
2.Article 3(1 )isreplaced bythefollowing :
"Bywayofderogation from Article 2(l),Member States mayauthorize until
31December 19&4 theuseinfoodstuffs ofthesubstances listed inAnnex
II,anduntil 30June 1980 themarketing offoodstuffs containing ghatti
gum.However asregards Karaya gumtheCouncil acting inaccordance with
theprocedure provided forin -Article 100oftheTreaty ,maydecide ,before
31December 1980 andafter anenquiry bytheCommissi on,todelete itfrom
theAnnex orotherwise change its status ."
3.Annex Iisamended asfollows :
(a)Theindent relating toE460microciystalline cellulose isreplaced
bythefollowing :
EEC No
IDesignation Conditions ofuse
E460 i)Microcrystalline cellulose
ii)Powdered cellulose

(b)Thefollowingisinserted:
2CNo Designation Conditions ofuse
E415XantnangumI
1
E441
IQuillaiaextract Exclusivelyinsoftdrinksand
inbeverageswheresoftdrinks
are'aningredient /,a'ndata.
Levelofnotmorethan200
mg/kgwherethisuseispermit­
tedundernationallaw
E442 Ammoniumphospnatides
E476Polyglycerol poly–
ricinoleate
E491 Sorbitanmonostearate
E92Sort)itantristearate
E493Sortaitanmonolaurate
E494 Sorbitanmonooleate
Lì495Sortitanmonopalmrtate
4.AnnexIIisreplacedbytheAnnextothisDirective..
Article2
15emberStatesshall,withinoneyearofthenotification ofthisDirective,
amendtheirlawsinaccordancewiththeprecedingprovisions,andshall
forthwithinformtheCommissionthereof.Thelawsthusamendedshallbe
implemented twoyearsafternotification ofthisDirective.
Article3
i» \
ThisDirectiveisaddressedtotheMemberStates.
DoneatBrussels, FortheCouncil
ThePresident

ANNSX
"ANïïEXII
Designation
Karayagum(synonym:sterculiagum)
Polyoxyethylene (20)sorbitanmonolaurate (synonym:polysorbate 20)
Polyoxyethylene (20)sorbitanmonopalmitate (synonym:polysorbate 40)
Polyoxyethylene(20)sorbitanmonostearate (synonym:polysorbate 60)
Polyoxyethylene (20)sorbitantristearate (synonym:polysorbate 65)
Polyoxyethylene (20)sorbitanmonooleate(synonym:polysorbate80)
Polyoxyethylene (8)stearate
Polyoxyethylene (40)stearate
Oxidativelythermallypolymerised soyabeanoilinteractedwithmono–and
anddi–glyceridesoffattyacids
Lactylatedfattyacidestersofglycerolandpropyleneglycol
Dioctylsodiumsulphosuccinate "