ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(79)500
Vol.1979/0171

Disclaimer
Conformément aurèglement(CEE,Euratom)n°354/83duConseildu1erfévrier1983
concernantl'ouvertureaupublicdesarchiveshistoriquesdelaCommunauté économique
européenneetdelaCommunautéeuropéennedel'énergieatomique(JOL43du15.2.1983,
p.1),telquemodifiéparlerèglement(CE,Euratom)n°1700/2003du22septembre2003
(JOL243du27.9.2003,p.1),cedossierestouvertaupublic.Lecaséchéant,lesdocuments
classifiésprésentsdanscedossierontétédéclassifiésconformément àl'article5dudit
règlement.
InaccordancewithCouncilRegulation(EEC,Euratom)No354/83of1February1983
concerningtheopeningtothepublicofthehistoricalarchivesoftheEuropeanEconomic
CommunityandtheEuropeanAtomicEnergyCommunity(OJL43,15.2.1983,p.1),as
amendedbyRegulation(EC,Euratom)No1700/2003of22September2003(OJL243,
27.9.2003,p.1),thisfileisopentothepublic.Wherenecessary,classifieddocumentsinthis
filehavebeendeclassified inconformitywithArticle5oftheaforementioned regulation.
InÜbereinstimmung mitderVerordnung(EWG,Euratom)Nr.354/83desRatesvom1.
Februar1983überdieFreigabederhistorischen ArchivederEuropäischen
Wirtschaftsgemeinschaft undderEuropäischen Atomgemeinschaft (ABI.L43vom15.2.1983,
S.1),geändertdurchdieVerordnung(EG,Euratom)Nr.1700/2003vom22.September2003
(ABI.L243vom27.9.2003,S.1),istdieseDateiderÖffentlichkeitzugänglich.Soweit
erforderlich,wurdendieVerschlusssachen indieserDateiinÜbereinstimmung mitArtikel5
dergenanntenVerordnungfreigegeben.

COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(79)500final
Brussels,25September 1979
Proposalfora
COUNCILDIRECTVE
amendingCouncilDirective78/25/EEContheapproximation of
thelawsoftheMemberStatesrelatingtothecolouring
matterswhichmaybeaddedtomedicinalproducts
(submittedtotheCouncilbytheCommission )
/-,
.•_^«y
COM(79)500final

I
Explanatory Memorandum
CouncilDirective78/25/EECof12December1977relatingtothecolouring
matterswhichmaybeaddedtomedicinalproductsreferstothelistof
colouringmattersauthorisedforuseinfoodstuffsintendedforhuman
consumption;thislistmakesadistinction betweencolouringmatterfor
bothmassandsurfacecolouringandcolouringmatterforsurfacecolouring
only.
Thisdistinction-whichreducesthealternatives opentoapharmaceuticals
industryalreadysubjectedtoseveretechnicalconstraints-isnotjusti­
fiedfromthepointofviewofthesafeguarding ofpublichealthsince
medicinalproductsaresubjectedtoanumberofpriortestsbeforeamarke­
tingauthorization isgranted.
Itwouldtherefore seemdesirabletoabolishthisdistinction formedicinal
products.

Proposal for a
COUNCIL DIRECTVE
amending Council Directive 78/25/EEContheapproximation of
the laws oftheMember States relating tothecolouring
matters which maybeadded tomedicinal products
THECOUNCIL OFTHEEUROPEAN COMMUNITIES ,
Having regard totheTreaty establishing theEuropean Economic Community ,
and inparticular Article 100thereof .
Having regard totheproposal from theCommission ,
Having regard totheopinion oftheEuropean Parliament ,
Having regard totheopinion oftheEconomic and Social Committee ,
(1)Whereas Article 1ofCouncil Directive 78/25/EEC stipulates that Member
States shall notauthorize ,for thecolouring ofmedicinal products for
human andveterinary use,anycolouring matters other than those covered
byAnnex I,Sections Iand II,ofCouncil Directive of23October 1962 on
theapproximation ofthe rules oftheMember States concerning the colouring
(2)matters authorized for use infoodstuffs intended for human consumption ,
Whereas Section Ioftheabovementioned Annex covers colouring matter for
both mass andsurface colouring ,andSection IIcovers colouring matter for
surface colouring only ,
Whereas there isnojustification onpublic health grounds formaintaining
inthe case ofmedicinal products thedistinction made int.ie case of
foodstuffs intended forhuman consumption between colouring matter forboth
mass andsurface colouring andcolouring matter forsurface colouring only .
Whereas Directive 78/25/EECshould therefore beamended accordingly ,
HAS ADOPTED THIS DIRECTIVE :
»
(1)0JNoL11,14.1.1978 ,p.18
(2)0JNo115,11.11.1962 ,p.2645 /62

H
Article 1
ThefollowingparagraphisaddedtoArticle1ofDirective78/25/EEC:
"However,inthecaseofmedicinalproducts,nodistinctionshallbemade
betweencolouringmatterforbothmassandsurfacecolouringandcolouring
matterforsurfacecolouringonly."
Article2
Ii
ThisDirectiveisaddressedtotheMemberStates.