26.9.92 OfficialJournaloftheEuropeanCommunities NoC249/5
II
(PreparatoryActs)
COMMISSION
AmendedproposalforaCouncilDirectiveamendingforthesixthtimeDirective76/768/EEC
ontheapproximationofthelawsoftheMemberStatesrelatingtocosmeticproducts(')
(92/C249/04)
COM(92)364final—SYN307
(SubmittedbytheCommissionpursuanttoArticle149(3)oftheEECTreatyon3September
1992)
C)OJNoC52,28.2.1991,p.6
ORIGINAL PROPOSAL AMENDED PROPOSAL
ProposalforaCouncilDirectiveamendingforthesixth
timeCouncilDirective76/768of27July1976onthe
approximationofthelawsoftheMemberStatesrelating
tocosmeticproductsAmendedproposalforaCouncilDirectiveamendingfor
thesixthtimeCouncilDirective76/768of27July1976
ontheapproximation ofthelawsoftheMemberStates
relatingtocosmeticproducts
Unchanged THECOUNCILOFTHEEUROPEAN COMMUNITIES ,
HavingregardtotheTreatyestablishingtheEuropean
EconomicCommunity,andinparticularArticle100a
thereof,
HavingregardtotheproposalfromtheCommission,
IncooperationwiththeEuropeanParliament,
HavingregardtotheopinionoftheEconomicand
SocialCommittee,
WhereaslegalambiguitiesinCouncilDirective
76/768/EECO,aslastamendedbyDirective
89/679/EEC(2),particularlyinArticles1and2,should
beremoved;
C)OJNoL262,27.9.1976,p.169.
OOJNoL398,30.12.1989,p.25.

NoC249/6 OfficialJournaloftheEuropeanCommunities 26.9.92
ORIGINALPROPOSAL AMENDEDPROPOSAL
Whereasithasbecomeapparentthatitisdesirablethat
dataontheingredientsemployedincosmeticproducts
begatheredwithaviewtotheassessment,ontheone
hand,ofallissuesrelatingtotheiruseand,ontheother,
oftheresultingactionatCommunitylevel,withaview
particularlytotheestablishmentofacommonnomen­
clatureofingredientsusedincosmeticproducts;whereas
thegatheringofthisdatacanbefacilitatedifthe
Commissioncompilesaninventoryoftheingredients
concerned;whereasthisinventoryisindicativeandisnot
intendedtoconstituteadefinitivelistofsubstancesused
incosmeticproducts;
Whereasgreatertransparency isneededregardingthe
ingredientsemployedincosmeticsifthelatteraretobe
placedonthemarketwithoutanypriorprocedureandin
ordertoobtainthenecessaryinformationonthefinished
productssolelyattheplaceofmanufactureorofinitial
importationintotheCommunityandprovidebetter
informationtotheconsumer;whereassuchtransparency
shouldbeattainedbyindicatingtheproduct'sfunction
andbyindicatingtheingredientsusedinacosmetic
productonitspackaging;whereaswhereforpractical
reasonsitisimpossibletoindicatetheingredientsand
anywarningsregardinguseonthecontainerorthe
packaging,suchindicationsshouldbegivenonan
enclosedleafletwithasuitablesymbol;
Whereas,withregardtothefinishedcosmeticproduct,it
shouldbemadeclearwhichinformation istobemade
availabletothemonitoringauthoritiesoftheplaceof
manufacture orofinitialimportationintothe
Communitymarket;whereasthisinformationshould
includeallthenecessaryelementsrelatingtoidentity,
quality,safetyforhumanhealthandtheclaimedeffects
ofthecosmeticproduct;
Whereasthecompetentauthorityshouldbeapprisedof
theplaceofmanufacture,forreasonsofmonitoring,and
oftheinformationneededforrapidandappropriate
medicaltreatmentincaseofdifficulties;
WhereastheCommissionshouldbeauthorizedtoamend
AnnexesIandVIIItoDirective76/768/EEC,inviewof
theirillustrativeandtechnicalnatures;

26.9.92 OfficialJournaloftheEuropeanCommunities NoC249/7
ORIGINAL PROPOSAL AMENDED PROPOSAL
Whereasassessmentofthesafetyofuseoftheingre­
dientsemployedincosmeticsandofthefinalproduct
musttakeaccountoftherequirementsofCouncil
Directive86/609/EEC(')regardingtheprotectionof
animalsusedforexperimentalandotherscientific
purposes,andinparticularArticle7(2)thereof,Whereasassessmentofthesafetyofuseoftheingre­
dientsemployedincosmeticsandofthefinalproduct
musttakeaccountoftherequirementsofCouncil
Directive86/609/EEC(')regardingtheprotectionof
animalsusedforexperimentalandotherscientific
purposes,andinparticularArticle7(2)thereof;whereas
experimentsinvolvingtheuseofingredientsonanimals
inordertosatisfytherequirementsofDirective
76/768/EECasreferredtoabovemustceaseafter1
January1998;whereas,however,defermentofthisdate
wouldhavetobeconsideredifsatisfactorymethodshave
notbeenlegallyacceptedpriortothatdate;whereasthe
Commissionmustreportonprogressachievedinthis
regard;
Whereasspecificcriteriaforcosmeticsnottestedon
animalsmustbedrawnup,
HASADOPTEDTHISDIRECTIVE : HASADOPTEDTHISDIRECTIVE :
Article1
Directive76/768/EECisherebyamendedasfollows:
1.Article1(1)isreplacedbythefollowing :
'1.A"cosmeticproduct"meansanysubstanceor
preparationintendedforplacingincontactwiththe
variousexternalpartsofthehumanbody(epidermis,
hairsystem,nails,lipsandexternalgenitalorgans)
orwiththeteethandthemucousmembranesofthe
oralcavitywithaviewtocleaningthem,perfuming
them,protectingthem,keepingthemingood
condition,changingtheirappearanceand/or
correctingbodyodours.'Article1
Directive76/768/EECisherebyamendedasfollows:
1.Article1(1)isreplacedbythefollowing :
'1.A"cosmeticproduct"meansanysubstanceor
preparationintendedforplacingincontactwiththe
variousexternalpartsofthehumanbody(epidermis,
hairsystem,nails,lipsandexternalgenitalorgans)
orwiththeteethandthemucousmembranesofthe
oralcavityexclusivelyorprincipallywithaviewto
cleaningthem,perfumingthem,protectingthem,
keepingthemingoodcondition,changingtheir
appearanceand/orcorrectingbodyodours.'
2.Article2isreplacedbythefollowing : Unchanged
Article2
Cosmeticproductsputonthemarketwithinthe
Communitymustnotcausedamagetohumanhealth
whentheyareappliedundernormalorreasonably
foreseeableconditionsofuse,takingaccount,in
particular,ofeverycommunication madeinthis
regardbythemanufacturerorhisauthorizedagent
orbyallothersresponsibleforplacingthese
productsontheCommunitymarket.'
OOJNoL358,18.12.1986,p.1. (')OJNoL358,18.12.1986,p.1.

NoC249/8 OfficialJournaloftheEuropeanCommunities 26.9.92
ORIGINAL PROPOSAL AMENDED PROPOSAL
2a.Thefollowingpoint(g)isaddedtoArticle4(1):
'(g)Ingredientsorcombinations ofingredients
testedonanimalsafter1January1998inorder
tomeettherequirementsofthisDirective.In
accordancewithprogressachievedin
developingsatisfactorymethodstoreplace
experimentsonanimals,theCommissionmay,
inaccordancewithArticle100aoftheEEC
Treaty,presentaproposaltotheCouncilto
defertheentryintoforceofthisprovision.The
Commissionshallpresentanannualreportto
theEuropeanParliamentandtheCouncilon
progressinthedevelopment ,validationand
legalacceptanceofalternativemethodsto
thoseinvolvingexperimentsonanimals.The
reportshallcontainprecisedataonthenumber
andtypeofexperimentsrelatingtocosmetic
productscarriedoutonanimals.TheMember
Statesshallbeobligedtocollectthisinfor­
mationinadditiontocollectingstatistics,as
laiddownbyCouncilDirective86/609/EEC
regardingtheprotectionofanimalsusedfor
experimentalandotherscientificpurposes.The
Commissionshallinparticularensurethe
development ,validationandlegalacceptance
ofexperimentalmethodswhichdonotuselive
animals.'
2b.Thefollowingparagraph 1(a)isaddedtoArticle4:
'Ingredientstestedonanimalsexclusivelyfor
purposesotherthantheiruseincosmeticproducts
shallbeauthorized,onconditionthatnoadditional
testingonanimalsiscarriedoutinordertomeet
therequirementsofthisDirective.'
3.ThefollowingArticle5aisinserted: 3.ThefollowingArticle5aisinserted:
'Article5a 'Article5a
1.Notlaterthan31December1993,the
Commissionshall,onthebasisinparticularofinfor­
mationsuppliedbytheMemberStates,compilean
inventoryofingredientsemployedincosmetic
products.1.Notlaterthantwoyearsfollowingthe
adoptionofthisDirective,theCommissionshall,on
thebasisinparticularofinformationsuppliedbythe
MemberStates,compileaninventoryofingredients
employedincosmeticproducts.
ForthepurposesofthisArticle"cosmetic
ingredient"meansanychemicalsubstanceorprep­
arationofsyntheticornaturalorigin,exceptfor
perfumeandaromaticcompositions,usedinthe
compositionofcosmeticproducts.ForthepurposesofthisArticle"cosmetic
ingredient"meansanychemicalsubstanceorprep­
arationofsyntheticornaturalorigin,exceptfor
perfumeandaromaticcompositions ,usedinthe
compositionofcosmeticproducts.

26.9.92 OfficialJournaloftheEuropeanCommunities NoC249/9
ORIGINAL PROPOSAL AMENDED PROPOSAL
Theinventoryshallbedividedintotwoparts:one
relatingtoaromaticandperfumeingredients,and
onerelatingtootheringredientsusedincosmetics.'
2.Theinventoryshallcontaininformationon:Unchanged
theidentityoftheingredient,inparticularits
chemicalnameand,whereappropriate,the
EINECS,CASandColorindexnumbers,
—thefunction(s)oftheingredientinthefinal
product,
—whereappropriate,restrictionsandconditionsof
useandwarningswhichmustbeprintedonthe
label.
3.TheCommissionshallpublishtheinventory
andshallupdateitperiodically .Theinventoryis
indicativeanddoesnotconstitutealistofthe
substancesauthorizedforuseincosmeticproducts
oranexhaustivelistofsubstancesusedinthese
products.'
4.InArticle6(1),theintroductoryphraseisreplaced
bythefollowing:
'1.MemberStatesshalltakeallmeasures
necessarytoensurethatcosmeticproductsmaybe
marketedonlyifthecontainerandpackagingbear
thefollowinginformationinindelible,easilylegible
andvisiblelettering,exceptfortheinformation
mentionedin(g)hereafterwhichmaybeindicated
onthepackagingalone:'.
5.Article6(1)(d)isreplacedbythefollowing:
'(d)particularprecautionstobeobservedinuse,
andespeciallythoselistedinthecolumn
"Conditionsofuseandwarningswhichmustbe
printedonthelabel"inAnnexesIII,IV,VIand
VII,whichmustappearonthecontainerand
packagingaswellasanyspecialprecautionary
information oncosmeticproductsfor
professionaluse,inparticularinhairdressing .
Wherethisisimpossibleforpracticalreasons,
thisinformationmustappearonanenclosed
leaflet,witheitherabbreviatedinformationon
thecontainerandthepackagingorthesymbol
giveninAnnexVIIIreferringtheconsumerto
theinformationspecified.''(d)particularprecautionstobeobservedinuse,
andespeciallythoselistedinthecolumn
"Conditionsofuseandwarningswhichmustbe
printedonthelabel"inAnnexesIII,IV,VIand
VII,whichmustappearonthecontainerand
packagingaswellasanyspecialprecautionary
information oncosmeticproductsfor
professionaluse,inparticularinhairdressing .
Wherethisisimpossibleforpracticalreasons,
thisinformationmustappearonanenclosed
leaflet,labelorcard,witheitherabbreviated
informationonthecontainerandthepackaging
orthesymbolgiveninAnnexVIIIreferringthe
consumertotheinformationspecified.'

NoC249/10 OfficialJournaloftheEuropeanCommunities 26.9.92
ORIGINAL PROPOSAL AMENDED PROPOSAL
6.Thefollowingpoints(f)and(g)areaddedtoArticle
6(1):6.Thefollowingpoints(f)and(g)areaddedtoArticle
6(1):
'(f)thefunctionoftheproduct,unlessitisclear
fromthedescriptionoftheproduct;'(f)thefunctionoftheproduct,unlessitisclear
fromthepresentationoftheproduct;
(g)alistofingredientsindescendingorderof
weightatthetimetheyareadded.Thislistshall
beprecededbyanappropriateindication
includingtheword"ingredients".Wherethisis
impossibleforpracticalreasons,theingredients
mustappearonanenclosedleaflet,witheither
abbreviatedinformationonthecontainerand
thepackagingorthesymbolgiveninAnnexVII
referringtheconsumertotheingredients
specified.Perfumeandaromaticcompositions
andtheirrawmaterialsshallbereferredtoby
theword"perfume".Ingredientsofaconcen­
trationoflessthan1%maybelistedinany
orderafterthoseofaconcentration ofmore
than1%.Colouringagentsmaybelistedin
anyorderaftertheotheringredients .(g)alistofingredientsindescendingorderof
weightatthetimetheyareadded.Thislistshall
beprecededbytheword"ingredients".Where
thisisimpossibleforpracticalreasons,the
ingredientsmustappearonaleaflet,labelor
card,witheitherabbreviatedinformationonthe
packagingorthesymbolgiveninAnnexVIII
referringtheconsumertotheingredients
specified.Theleafletmaybesuppliedwiththe
productifthecustomeristobeadvisedatthe
pointofsale.Forproductssoldwithoutexternal
packagingontraysordisplaystands,theingre­
dientsmayappearonaseparateleafletwhich
mustbepresentedorsuppliedinapocket
attachedtothedisplayunit.Perfumeand
aromaticcompositionsandtheirrawmaterials
shallbereferredtobythewords"perfume"or
"aroma".Ingredientsofaconcentrationofless
than1%maybelistedinanyorderafterthose
ofaconcentrationofmorethan1%.Colouring
agentsmaybelistedinanyorderaftertheother
ingredients .Forproductsmarketedinseveral
colourshades,allcolouringagentsusedinthe
rangemaybelisted,providedthatthewords
"maycontain"areadded.
Insteadofinformationontheingredientsof
colouringagentsaddedtoeachproduct,the
colouringagentsinanassortmentofcosmetic
productssoldtogetherinthesamepackaging
maybelistedinanyorderinasinglelist,
providedthatthisisnotmisleadingandthatitis
pointedoutthatthelistappliestoallthe
products.
Wherethereisanexistingorforeseeable
shortageofingredients,thedeclarationmay
nameasubstituteingredient,whichmustbe
listeddirectlyaftertheingredientnormallyused
andprecededbytheword"or".

26.9.92 NoC249/11 OfficialJournaloftheEuropeanCommunities
ORIGINALPROPOSAL AMENDED PROPOSAL
Wheretheproductissoldbymailorder,infor­
mationontheingredientsmaybegivenina
brochureorcateloguesenttoeachpurchaser,
providedthatthepurchaseristherebyableto
identifytheinformationrelatingtoeach
product.
Samplesusedfortestingandfreesamplesare
notrequiredtohavealabellistingtheingre­
dients.
InaccordancewiththeArticle10procedure,
theCommission shall,nolaterthan31
December1993,adoptthecriteriaand
conditionsunderwhichamanufacturermay,
forreasonsoftradesecrecy,applynotto
includeoneormoreingredientsonthe
abovementioned list.'InaccordancewiththeArticle10procedure,
theCommissionshall,nolaterthantwoyears
followingtheadoptionofthisDirective,adopt
thecriteriaandconditionsunderwhichamanu­
facturermay,forreasonsoftradesecrecy,apply
nottoincludeoneormoreingredientsonthe
abovementioned list.'
6.(a)Article6(3)isreplacedbythefollowing :
'3.MemberStatesshalltakeallmeasures
necessarytoensurethatinthelabelling,presen­
tationforsaleandadvertisingofcosmetic
products,thewording,useofnames,trademarks,
imagesorothersigns,figurativeorotherwise,
suggestingacharacteristicwhichtheproductsin
questiondonotpossess,shallbeprohibited .In
particular,anyreferencetotestingonanimals
muststateclearlywhetherthetestscarriedout
involvedthefinishedproductoritsingredients,
specifying,inthelattercase,whethertheyare
usedexclusivelyincosmeticsorwhetherthey
havepreviouslybeenusedforothercategoriesof
products.'
7.Article7(2)isreplacedbythefollowing:
'2.Theymay,however,requirethatthe
particularsprovidedforinArticle6(1)(b),(c)and
(d)beexpressedatleastintheirownnationalor
officiallanguageorlanguages,theymayalsorequire
thattheparticularsprovidedforinArticle6(1)(f)
and(g)beexpressedinalanguageeasilyunderstood
bytheconsumer.Tothisend,theCommissionshall
adoptacommoningredientsnomenclature in
accordancewiththeArticle10procedure.'7.Article7(2)isreplacedbythefollowing :
'2.Theymay,however,requirethatthe
particularsprovidedforinArticle6(1)(b),(c),(d)
and(f)beexpressedatleastintheirownnationalor
officiallanguageorlanguages,theymayalsorequire
thattheparticularsprovidedforinArticle6(1)(g)
beexpressedinalanguageeasilyunderstoodbythe
consumer .Tothisend,theCommissionshalladopta
commoningredientsnomenclature inaccordance
withtheArticle10procedure.'

NoC249/12 OfficialJournaloftheEuropeanCommunities 26.9.92
ORIGINALPROPOSAL AMENDED PROPOSAL
8.Article7(3)isreplacedbythefollowing:
'3.Furthermore ,aMemberStatemayrequire,for
purposesofpromptandappropriatemedical
treatmentintheeventofdifficulties,thatthequali­
tativeandquantitativeformulaoftheproductbe
madeavailabletothecompetentauthority,which
shallensurethatthisformulaisusedonlyforthe
purposesofsuchtreatment.8.Article7(3)isreplacedbythefollowing :
'3.Furthermore ,aMemberStatemayrequire,for
purposesofpromptandappropriatemedical
treatmentintheeventofdifficulties,thatadequate
andsufficientinformationontheproductbemade
availabletothecompetentauthority,whichshall
ensurethatthisinformation isusedonlyforthe
purposesofsuchtreatment.Thegenericformulaeof
theproductandspecificdetailsrelatingtothe
variousindividualingredientsshallbeprovided.
MemberStatesshalldesignatethatcompetent Unchanged
authorityandsenddetailsthereoftothe
Commission ,whichshallpublishthisinformationin
theOfficialJournaloftheEuropeanCommunities'
9.ThefollowingArticleisinserted:
!Article7a
1.Themanufacturerorhisagentprovidedheis
establishedintheCommunity ,ortheperson
responsibleforplacingimportedcosmeticproducts
ontheCommunitymarket,shall,forcontrol
purposes,keepthefollowinginformationreadily
availabletothecompetentauthoritiesoftheMember
Stateconcernedattheplaceofmanufactureor,in
thecaseofimportationfromanon-membercountry,
attheplaceofinitialimportationintoCommunity
territory:
(a)thequalitativeandquantitativeformulaofthe
product;(a)Thequalitativeandquantitativeformulaofthe
product;withregardtoaromaticcompositions
andperfumes,thisinformationshallbelimited
tothenameandcodenumberofthecompo­
sitionandtheidentityofthesupplier,exceptfor
thosesubstanceslistedinAnnexesIII,IV,VI
andVIIofCouncilDirective76/768/EEC
referredtoabove.
(b)thephysico-chemical andmicrobiological specifi-Unchanged
cationsoftherawmaterialsandthefinished
productandthepurityandmicrobiological
controlcriteriaofthecosmeticproduct;
(c)themethodofmanufacturecomplyingwiththe
goodmanufacturing practicelaiddownby
Communitylawor,failingthat,laiddownby
thelawoftheMemberStateconcerned;
(d)assessmentofthesafetyforhumanhealthofthe
finishedproduct.Tothisend,themanufacturer
shalltakeintoconsiderationthegeneraltoxico­
logicalprofileoftheingredient,itschemical
structureanditslevelofexposure .

26.9.92 OfficialJournaloftheEuropeanCommunities NoC249/13
ORIGINALPROPOSAL AMENDEDPROPOSAL
Shouldthesameproductbemanufactured at
severalplacesonCommunityterritory,the
manufacturer maychooseasingleplaceof
manufacturewherethisinformationwillbekept
available.Withregardtothis,andwhenso
requestedformonitoringpurposes,heshallbe
obligedtoindicatetheplacesochosentothe
monitoringauthority/authoritiesconcerned;
(e)thenameandaddressofthequalifiedpersonor
personsresponsiblefortheassessmentreferred
toat(d).Thispersonmusthavereceived
universitytraininginthefieldofnatural
sciences;
(f)existingdataonundesirableeffectsonhuman
healthresultingfromuseofthecosmetic
product;
(g)proofoftheeffectclaimedforthecosmetic
product,wherethisisjustifiedbythenatureof
theproduct.
2.Theassessmentofthesafetyforhumanhealth
referredtoinparagraph 1(d)ofthisArticleshallbe
carriedoutinaccordancewiththeprinciplesofgood
laboratorypracticelaiddowninCouncilDirective
87/18/EECof18December1986ontheharmon­
izationoflaws,regulationsandadministrative
provisionsrelatingtotheapplicationoftheprinciples
ofgoodlaboratorypracticeandtheverificationof
theirapplicationfortestsonchemicalsubstances(1).
3.Theinformationreferredtoinparagraph 1
mustbeavailableinthenationallanguageor
languagesoftheMemberStateconcerned,orina
languagereadilyunderstoodbythecompetentauth­
orities.
4.Themanufacturerorhisagent,providedheis
establishedintheCommunity,ortheperson
responsibleforplacingimportedcosmeticproducts
ontheCommunitymarket,shallnotifythe
competentnationalauthorityoftheaddressofthe
placeofmanufactureorofinitialimportationinto
theCommunityofcosmeticproductsbeforethe
latterareplacedontheCommunitymarket.
5.MemberStatesshalldesignatethecompetent
authoritiesreferredtoinparagraphs 1and4and
shallsenddetailsthereoftotheCommission ,which
shallpublishthisinformationintheOfficialJournal
oftheEuropeanCommunities .
OOJNoL15,17.1.1987,p.29.'

NoC249/14 OfficialJournaloftheEuropeanCommunities 26.9.92
ORIGINAL PROPOSAL AMENDED PROPOSAL
10.Article8(2)isreplacedbythefollowing :
'2.Theamendmentsnecessaryforadaptingto
technicalprogresstheAnnexestothisDirectiveand
thecommonnomenclatureofingredientsusedin
cosmeticproductsshallbeadoptedinaccordance
withthesameprocedure,afterconsultationofthe
ScientificCommitteeonCosmetology'
11.TheAnnexisaddedasAnnexVIII.
Article2
1.MemberStatesshalltakeallnecessarymeasuresto
ensurethatfrom1January1997neithermanufacturers
norimportersestablishedwithintheCommunityplace
onthemarketproductswhichfailtocomplywiththe
provisionsoftheDirective.
2.MemberStatesshalltakeallnecessarymeasuresto
ensurethattheproductsreferredtoinparagraph 1
cannotbesoldordisposedoftotheultimateconsumer
after31December1997.
Article3
1.MemberStatesshallbringintoforcethelaws,
regulationsandadministrative provisionsnecessaryto
complywiththisDirectivenotlater,than31December
1993andshallinformtheCommissionthereofforthwith .Article3
1.MemberStatesshallbringintoforcethelaws,
regulationsandadministrative provisionsnecessaryto
complywiththisDirectivenotlaterthantwoyearsafter
theadoptionofthisDirectiveandshallinformthe
Commissionthereofforthwith .
Unchanged WhenMemberStatesadopttheseprovisions,theseshall
containareferencetothisDirectiveorshallbeaccom­
paniedbysuchreferenceatthetimeoftheirofficial
publication .Theprocedureforsuchreferenceshallbe
adoptedbyMemberStates.
2.MemberStatesshallcommunicate tothe
Commissionthetextsoftheprovisionsofnationallaw
whichtheyadoptinthefieldgovernedbythisDirective.
Article4
ThisDirectiveisaddressedtotheMemberStates.

26.9.92 OfficialJournaloftheEuropeanCommunities NoC249/15
ANNEX
AnnexVIII