ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(75)147
Vol.1975/0051

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(75)147 final
Brussels *10April 1975
Alteration ofthe proposal for aCouncil Directive
ontheapproximation ofthelaws ofMember States
relating tocosmetic products
(presented bytheCommission totheCouncil pursuant
tothesecond paragraph ofArticle 149oftheEEC
Treaty )
COM(75 )1H7final

EXPLA1TAT0RY IGI-'ORAITDUM
•i
1.Themain objective ofthedirective dealing -with Cosmetic Products which
wassenttotheCouncil inOctober 1972^"wastheelimination oftrade
"barriers toensure a "better protection ofconsumers "byforbidding the
•marketing ofcosmetic products which areharmful tohealth .Inputting
into practice thelatter principle theCommission hadtodecide whether
tolist substances that could beregarded asharmful ,that isanegative
list ,orsubstances which could beregarded assafe ,that isapositive
i
list ,both asused informulated products .
Itisnecessary tohave much more information about asubstance to
declare that itissafe tousethan itistodeclare that itisharmful ;
accordingly theCommission decided that itwasappropriate tomake a
•general list offorbidden substances ,that isAnnex II,andalimiting
andpositive list ,that isAnnex III ,tothedirective ,only whore the
evidence wassoundly based andcomplete .Where toxicological testing
wasnotyetcomplete atime limit ofthree years wasimposed forthe
review ofanumber ofpermitted substances andthey were placed in
Annex IV.
Theform ofthedirective issuch that itcanbereadily modified by
theaddition offurther positive lists where these arethought necessary
fortheimproved protection ofpublic health .TheCommission considers
that asafirst stage these lists could cover ,.forinstance ,antioxidants ,
.colorants ,hair dyes ,preservatives and .ultra violet filters .
Ingiving itsadvice ontheDirective theEuropean Parliament ,both in
2 *itsinitial report anditscomplementary report ,recommended therapid
adoption ofpositive lists .TheEconomic andSocial Committee 3madea
similar recommendation while recognising theproblems which arise in
~the préparation ofsuch liste .
« /
OJïïoC133 ,23December 1972
OJIloC62,31July 1973
3OJHoC60/17,26July1973

SinceOctober1972,thedateoftransmission oftheproposaltothe
Council,theservicesoftheCommission ha,ve,therefore,studiedmore
deeplythetoxicological characteristics ofcertaincategoriesofsub­
stances.Asaresultofthesestudiesandintakingnoteoftheviews
expressedbytheEuropeanParliament ,theEconomicandSocialCommittee
andconsumerorganisations ,theCommissionproposedtoinsertanew
Article11"bis"inthepropositioninordertoaddsubsequently posi­
tivelistsforcertainsubstances .
IncompilingthenegativelistappearinginAnnexIIitwasfurther
extendedbythefirstproposition ofmodification proposedbythe
CommissionfollowingthereceiptoftheadviceoftheEuropean
Parliament .IncompilingthisAnnexIIitwasnotdesirableor
practicabletoincludethemanytensofthousandsofsubstancesexist­
ingwhichareharmfultohealth,butonlythosewhichintheopinion
oftheexpertsoftheMemberStatesandoftheCommission hadoccured
orcouldoccurassuchorascontaminants incosmeticproducts.Annex
IImast,therefore,beinterpretedasanextensionofArticle2ofthe
directivebywhichtheuseoftoxicsubstancesinharmfulconcentrations
wouldbeforbidden.
TheCommission ,therefore,considersthatArticle12,whichallowsimmediate
actiontobetakenintheeventoffurthersubstancesbeingintroducedinto
thecosmeticfieldwhichareharmufltohealth,isessentialtothedirective.
Itis,therefore,proposinganewversionofthisclausebasedontheagree­
mentforsafeguardclausesindirectivesinthefieldoftechnicalbarriers
totrade.
Cosmeticproductshaveawidevarietyofusesandwhileitv/ouldbeunreason­
abletosaythattheyshouldnotbeharmfulunderanyconditionsofmisuse,
itisnecessarytoprovideforthepossibilityofdamagetoareasofthe
bodycontingentorcapableofcontactingthesiteofapplication .Thus
ashampooshouldnotbeharmfultotheeyes,noradentifricepoisonous
ifswallowed.TheCommission ,therefore,proposesanewversionof
Article2inv/hichforseeableconditionso£useinthesenseexplained
abovearetakenintoaccount.

Inconsideringthepossibilities ofpoisoning'byacompletemisuseofa
producttheCommissionisoftheopinionthatthereshouldbearequire­
mentforthenecessaryinformationforprompttreatmenttobeavailable.
Thewaysinwhichanti-poisoninformationisavailablevaryintheMember
StatesandtheCommission "doesnotconsiderthatitshouldproposea
harmonisation oftheseprocedureswhicharepeculiartoandaretheresp­
onsibilityofeachKeraberState,Nevertheless ,theCommissionconsiders
thatitisappropriatetoenvisageatCommunityleveldispositions
whichimposeanobligationonthemanufacturers toprovidesuchinform­
ation,.imposingaparallelobligationontherelevantauthoritiesin
ordertorespecttradesecrets^toreleasetothirdpartiesonlythat
information whichisessentialtotheeffectivetreatmentofthecondition.
TheCommission,therefore,proposestoaddafurthersub-paragraph to•
Artiole7givingeffecttothisrequirement.

Altération of
• *
theproposal fortaCouncil Directive on "theapproximation ofthelaws
oftheKember States relating tooosmetio produots
•• • .A
Theproposal foraDirective forwarded totheCouncil on19October
1972 isamended bythefollowing :
–arewording ofArticle 2
–theaddition ofafurther paragraph (number 3)toArticle 7«
–anev ;Article 11"bis". .
.»-arewording ofArticle 12.
Article 2
Thefollowing text shall replace thetext ofthis article :
• « •
Cosmetics products putonthemarket within .theCommunity must notbe
liable tocause damage tohuman health when they areapplied under normal
conditions ofuse .
Article 7
».
Thefollowing paragraph isadded tothetext ofthis article : J!
è
Furthermore ,aMember State mayrequire that inorder that prompt and
appropriate ,treatment isavailable forcases ofpoisoning ,adequate
andsufficient information regarding harmful substances contained in
cosmetic products ismade available tothecompetent authority who
shall ensure that this information shall only beused forthe
• •.
.proposes oftreatmsnt . . >
Jm * ~ ■ ' ' "
Article 11"bis" ,
Oneyear atthelatest after theexpiry of ..theperiod provided forin ^
Article 14.paragraph 1,fortheimplementation bytheICember States

ofthepresentdirective ,the-Commission ,onthe"basisofresultsof
thelatestscientificandtechnicalresearch,willsendtotheCouncil
appropriatepropositions establishinglistsofpermittedsubstances.
Article12
Thefollowingtextshallreplacethetextofthisarticle:
1.WhereaIlemberStatefindsthatacosmeticproduct,althoughsatis­
fyingtherequirements ofthisDirective ,presentsahealthorsafety
risk,itmay,temporarily ,prohibitwithinitsterritorytheplacing
onthemarketofthatcosmeticproduct.Itshallimmediately inform
theCommissionandtheotherliemberStatesofthisactionandgive
reasonstherefore.
2..TheCommissionshallwithinsixweeksconsultwiththeKembcrState
concerned,thenexpresswithoutdelayitsopinionandtakethe
appropriate steps.
3.AccordingtotheprocedurelaiddowninArticle 11oftheDirective
of27June19^7itshallbeimmediatelydecidediftechnicalamend­
mentstotheAnnex(s)oftheDirectivearenecessary.TheMember
Statecanmaintainitsinterdictionuntiladecisionhasbeentaken,
eitherbytheCouncilorbytheCommissionaccordingtotheafore­
mentionedprocedure.