ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(73)1733
Vol.1973/0299

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(73)1733Final
Brussels,17October1973
,.AMENDMENT TO
theproposalforaCouncilDirectiveontheapproximation
ofthelawsofMemberStatesrelatingtocosmetic
products.
i
(PresentedbytheCommissiontotheCouncilpursuanttothe
secondparagraphofArticle149oftheE.S.C.Treaty)
COM(73)1733final

EXPLANATORY MEMORANDUM
AspartoftheGeneralProgrammefortheremovaloftechnicalobstacles
1totradeadoptedbytheCouncilon28May19^9>theCommissionaddressed
totheCouncilon19October1972aproposalforaDirectiveonthe
approximation ofthelawsoftheMemberStatesrelatingtocosmetic
products.
TheEuropeanParliamentdelivereditsopiniononthisproposalfora
2Directiveduringitssessionof6July1973.TheCommissionhas
carefullyexaminedthecommentscontainedintheopinionandhasdecided
totakeappropriateactiononsomeofthem,and,tothisend,inpursuance
ofArticle149?secondparagraphoftheTreaty,toputforwardthe
followingproposalsforamendmentstotheoriginalproposalfora
Directive:
■-Article6(3)and(4);
-Article11(2);
■-Article12*
-Article14;
Theseproposalsforamendmentsareintendedtogivegreaterclarityto
Certainrequirements relatingtothelabellingandpresentation forsale
ofcosmeticproducts,tomakeclearerandmorepracticaltheCommunity
safeguardprocedureprovidedforcasesinwhichacosmeticproductwhich
complieswiththeseprovisionsconstitutes ahazardtohumanhealth.
Theyarealsointendedtoremovefromtheproposaltheadditionalperiod
providedforthesaleofoldstocks,
Furthermoretheyarcforthepurposeofamending,inconnectionwith
theCommunity'senlargement ,thedistribution ofvotesintheCommittee's
procedure.
TheCommissionalsoproposestheamendmentandexpansionofAnnexesII
(Listofsubstanceswhichcosmeticproductsmustnotcontain),III,Part
1(Listofsubstanceswhich,cosmeticproductsmustnotcontain,except
subjecttotherestrictionslaiddown)andIV,Part1(Listofsubstances
provisionally allowed).
Informulatingthelastmentionedproposalsforamendments ,theCommission
hastakenaccountoftheopinionsoftheexpertswhoassistitindrawing
upthetechnicalannexestotheproposalforaDirective.
10JNoC76,17June1969OJNoC62,31July1973.

AyFrTDE;3.^'nTC
«s-rssc-^t~sx^in:aiyi
theproposalforaCouncilDirectiveontheapproximation ofthelawsof
MemberStatesrelatingtocosmeticproducts
theCommission on19October1972
TheproposalforaDirectiveforwardedtotheCouncixon19October1972
isamendedbythefollowing:
–amendmentstoArticle6(3)and(4)j-acorrectiontoArticle11(2);
-therewordingofArticle12;
--deletionofArticle14(2);
-amendmentstoAnnexesII,IIIandIV.
Article6
Thetextofparagraphs (3)and(4)isexpandedasfollows:
3.Thespecialprecautionsofuse,and,inparticular ,thoseindicatedin
thecolumn"Conditionsofuseandwarningstdiichmustappearonthelabel"
inAnnexesIIIandIVshallappearlegiblyonthecontainer ;wherethis
isimpossibleforpracticalreasons,theseindicationsshallappearon
theoutsidepackagingandonanenclosedleaflet,butinthiscasean
abbreviatedexternalindication mustappearonthecontainer,referring
totheindications mentioned.
4.Theuse,bothinthelabellingandinthepresentation forsaleof
theproductscoveredbyArticle1andinthepublicityconcerningthem,
inwhateverformthismaybe,ofnames,trademarks ,imagesorother
signs,visual,cinematographic orotherdisplays,suggestingacharacteristic
whichtheproductsconsidereddonotpossess,orattributingthereto
effectswhicharenot,orareinsufficientlyestablishedsclerrtifically ,
shallbeprohibited .
Article11
Thetextofthesecondparagraphshallbeamendedasfollows:
2.Therepresentative oftheCommissionBhallsubmittotheCommittee
adraftofthemeasurestobetaken.TheCommitteeshallrender
itsOpiniononthisdraftwithinaperiodoftimewhichtheChairman
mayfixaccordingtotheurgencyofthematterinhand.Itshall
actbyamajorityof41votes,thevotesoftheMemberStatesbeing
weightedaslaiddowninArticle148(2)oftheTreaty.The
Chairmanshallnotvote.

2
Article12
ThetextofthisArticleisreplaced "bythefollowing:
1.IfaMemberStateascertainsthatacosmeticproductconstitutesa
hazardtohealth,althoughconformingtotherequirements ofthis
Directiveand"beingusedasdirected,thisStatemay,foramaximum
periodofoneyear,prohibitinitsterritorythesale,puttingintocircula?-
tionoruseofthecosmetic .productinquestion.Itshallimmediately
communicatethistotheotherMemberStatesandtotheCommission,
acoompanied byastatementofgrounds,
2.TheCommissionshallconsulttheMemberStatesinvolvedwithinsix:
weeks.Itshalldeliveritsopinionwithoutdelayandtakethe
necessarymeasures.OntheinitiativeoftheCommissionitshall
•bedecidedwithoutdelay,inaccordancewiththeprocedureprovided
forinJkrtiole100oftheEECTreatyorwiththatspecifiedin
Article11ofthisDirective,whethertheDirectivemustbeamended.
Ifnecessary,thenecessaryamendmentsshallbeadoptedbyDirective.
.,Th.etimelimitreferredtoinParagraph(1)shallbeextendeduntil
theprocedureinitiatedhasbeen'completed,butnotformorethan
oneyear.
Article14
Section2isdeleted.
AnnexII-listofsubstanceswhichcosmeticproductsmustnotcontain.
Thefollowingsubstanceshavebeenaddedtothelists
426.Diphenhydramine (2Benzhydroxy--N,Dimetbylethylamine )anditssalts.
427•p-tertbutylphenolanditsallergenicderivatives.
428.p-tertbutylpyrocatechin
429«Dihydrotachisterol(AT10)...

3
430.Thiourea
431.Derivativesof"thiourea,exceptthoseexpresslymentionedin
AnnexIV.
432.Dioxane(1»4diethylenedioxide).
433.Morpholine.
434•Preparations basedonpyrethrum.
435.Pyriamino-amsole moleate.
436.P;/.âbenzaminé.
437•Tetrachlorosalicylanilide .
43S.Dichlorosalicylanilide .
439?Tetrabromosalicylanilide .
440.Dxbromosalicylamide .
441*Bithionol. ;
44-2.TinI--aiuicmonosulphides.
443»Tliiramicdisulphidcs.
444»Bimethylforiaamide .
445•Xylidines(allisomers). ;
446.Benzylidene acetone.
447.Coniferylbenzoate,exceptfornormalcontentinnaturalessences
used.
443»Furocumarin ,exceptfornormalcontentinnaturalessencesused»
449»Laurel01I.
450*Sassafrasoilcontainingsafrole.
45^»Iodothymol.
AnnexIII:Part1
Listofsubstanceswhichcosmeticproductsmustnotcontain,
exceptsubjecttotherestrictions laiddown.
•Item-No27–-Hoxachlorophene -.isdeleted.. ...•
Thewords"andmuds"aredeletedonPage4}note(1),beginningof
secondparagraph.
Thesubstances cruotedbelowareadded.

4
Restrictions :
I
IReference Product Use!
Maximum jOther jConditions !
Nuinber j permissible limiterions Iofuseandj
concentration and warnings
I.
!"requirements •whichmust
!
i-•,I
1}
ibeprintedl
!
I■'ontheI
label
a b c d"If
27Quinine (a)shampoos0,§%)expressed contains
and(b)hairj0,2%(asquinine quinine
itssaltslotions0
base
! i»
I
28ι
jHydroxy-8- 0.3$expreséed notfor
qumolme
IasbaselusemI
I
andits Ianti-
i
sulphate■sunburn
iSproducts,' '|
post
sunbathing
mroducts
ahdbaby
powders
11τ
Formai-I prohibited
deliydeI­
i■
]aerosols
29iNitrosolely I0.31o
unethane asi
i
t..
corrossion■
inhibitor
I
!jfort
i
aérosolI
i
i
I
.1 ■packsI
I

5
AnnexIViPari;1
»
Listofprovisionally acceptablesubstances.
Thefollowingisaddedtoitem22~xylocaine:
Reference iProduct
nuraberRestrictions
Use i-icucinium
permissible
concentrationConditions of
useandwarnings
tobeprintedon
thelabel
e
22xylocaine
(lidocaine
USP)
(lignocaine
BP)aftershave
lotion
aftersun
lotion0.1%
allowed
■Thefollowingsubstanceshavebeenadded:
23hexochlo-
rophanei(a)
jfcoapsand
jpliajnpoos
!(d)
.aerosol
jSprays
;(c)
jbody
deodorants
!(d)
btlier
Uses\/0
0.5/o
0.1£
otherrastnetions
prohibitedin
cosmeticproducts
foruseonchildren
>elowtheageof10contains
hexachlorophone
notforuse
onchildren
belowtheâgeof
10
Productsfor
intimate
hygienenotto
beused
duringpregnanclr
24 maximumcontent
100ppminthe
finishedproduct