ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(78)488
Vol.1978/0181

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(78)488 final.
Brussels.29September1978
Proposalfora
COUNCILDIRECTIVE
amendingforthe14thtimeDirective64/54/EEContheapproximation of
thelawsoftheMemberStatesconcerningthepreservatives
authorizedforuseinfoodstuffsintendedfor
humanconsumption
(submittedtotheCouncilbytheCommission)
W :\# "Ε*/^7- \te*%wï*'HviaJ
C0M<78)488final.
t

EXPLANATORY NOTE
1*TheannexofCouncilDirective64/54/EECof5November1963onthe
approximation ofthelawsoftheMemberStatesconcerningthepreservatives
authorizedforuseinfoodstuffsintendedforhumanconsumption as
modified "bytheCouncilDirective76/629/EECof20July1976^-
authorisesthepresenceofthiabendazole atuptoamaximumresidual
amountof6mg/kgforcitrusfruitand3mg/kgforbananas.This
authorisation hasbeengivenonatemporarybasisbytheDirectiveof
20July1976upto1January1979"topermitthenecessaryexamination
totakeplaceon<theefficacityoftheadditive,andinparticularthe
leveltoberetaineddefinitively.
J '
2.Asfarasquestionsofsafetyinusewereconcerned,theCommission's
proposalwasbasedontheadviceoftheScientific CommitteeforFood
of2April1976«TheCommissionhasreconsultedtheCommitteeonthe
basisoftoxicological andtechnological datasubmittedtoitsince
thatdate.On23June197&"theScientificCommitteeforPood
advisedtheCommissionthatafterconsideringalltherelevanttoxicological
datatheCommitteecouldestablishanADIof0.3mg/kgbodyweightfor
thiabendazole whichitunderstands tobethesameasthatestablished
bytheJointFAO/WHOCommitteesonpesticideresidues.TheCommittee
hasbeenprovidedwithagooddealofinformation concerningresidues
-ofthiabendazole inrawagricultural productsandinfoodcommodities ,
-andsemedataonthetotalhumanintakefromallsources,includingthe
intakeresultingfromtheuseofthiabendazole asapesticideandin
veterinarymedicine.
Intheabsenceofconvincingevidenceoftechnological justification
foranincreaseinthelevelsalreadystipulatedintheDirectiveon
Preservatives ,theCommitteerecommendsthattheprovisionsinthe
Directivebemaintained andthatthepermittedresiduelevelsfor
citrusfruitsandbananasshouldnotberaised.
X0JNo12of27.1.1964,P.161/164
20JNoL223of16.8.1976,p.23

Thepresortproposalimplementsthisadvice "bythedeletionofthetime
periodintheDirectiverelatingtothiabendazole®
Followingconsultations withtheAdvisoryCor-imitteeforPoodtheCommission
alsoproposesthereintroduction ofthemandatorylabellingprovision
forcitrusfruitsold"byretail.Thisprovisionwastemporarily
suspendeduntiladefinitivedecisionwastakenontheinclusionof
Thiabendazole inthetext#
TheCommissionhas"beeninformedthatthereistechnological justification
inhavingseveralpermittedtreatmentagentsfortheprotectionof
fruits(inthiscasecitrusfruitandbananas)againstdeterioration
bymicroorganisms becausethespectrumofactivityisnotthe'samefor
eachsubstance# TheCommissioncontinuestoexaminethepossibility of
proposingacomprehensive Directiveonsuchfruittreatmentagentsbtxt
hasnotyetcompletedthenecessaryconsultations .,Inthemeantimethe
CommissionseesnoreasontosuggestotheramendmentstotheDirective
onpreservativesinrespectoftheviseofbiphenyl(E230),orthophenylphenol
(E23l)andsodiumorthophenylphenate (E232)*

ProposalforaCouncilDirectiveamendingfor"theI4"th"timeDirective
64/54/BEContheapproximation ofthelawsoftheMemberStatesconcerning
thepreservatives authorizedforuseinfoodstuffsintendedforhuman
consumption
THECOUNCILOPTHEEUROPEAN COMMUNITIES
HavingregardtotheTreatyestablishing theEuropeanEconomicCommunity,
andinparticularArticle100thereof,
HavingregardtotheproposalfromtheCommission,
HavingregardtotheopinionoftheEuropeanParliament,x
HavingregardtotheopinionoftheEconomicandSocialCommittee,
WhereasCouncilDirective64/54/EECof5November1963ontheapproximation .
ofthelawsoftheMemberStatesconcerningthepreservatives authorizedfor
useinfoodstuffsintendedforhumanconsumption^,aslastamended "by
Directive78/l45/EEC2,andinparticular "byDirective76/629/EEC"*,
providesforthetemporaryuseofthiabendazole -until1January1979ata
maximumresiduelevelof6mg/kginthecaseofcitrusfruitand3mg/kginthe
caseofbananas;
Whereas,onatoxicological basis,theuseofthiabendazole onthesurfaceof
thesefruitsinquantitiesleadingtosuchresiduesinthe.wholefruit
isacceptable ;
Whereasexperienceintheuseofthiabendazole hasshownthatthemaintenance
oftheselevelsistechnologically justified;
Whereas/therefore,itisnowpossibletotakeafinaldecisiontoauthorize
theuseofthiabendazole withoutprejudice.toitspossibleinclusionin
subsequent Communitysystemonthetreatmentoffruitsandvegetables ;
Whereas,therefore,themandatorylabellingprovisionforcitrusfruitsold
byretailoanbereintroduced. " . .
X0JNo12of27.1.1964,P.161/64 '
20JNoL44of15.2.1978,p.23
30J.NoL223of16.8.1976,p.3

HASADOPTEDTHISDIRECTIVE :
Article1
InNoE233ofSectionIoftheAnnex"toDirective64/54/EEC,the
column"Conditions ofuse"isamendedasfollows:
1*Thetextofsubparagraph (b)(ii),secondindent,shall"bereplaced
"bythefollowing:
intheretailtrade,avisibleindicationshall "begiven
ensuring "beyonddoubtthattheconsumerismadeawarethatthe
fruithas"beentreated."
2.Subparagraph (c)isdeleted*
Article2
MemberStatesshall"bringintoforcenotlaterthan31December1978
thelaws,regulations oradministrative provisionsnecessarytocomply
with,thiaDirectiveandshallforthwithinformtheCommissionthereof.
Article3
ThisDirectiveisaddressedtotheMemberStates