ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(81)653
Vol.1981/0195

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(81)653final
Brussels,11November 1981
Proposalfora
COUNCILDIRECTIVE
amendingDirective 76/768/EEContheapproximation ofthelawsof
theMemberStatesrelatingtocosmeticproducts
(submittedtotheCouncilbytheCommission)
7
C0M(81)653final

EXPLANATORY MEMORANDUM
1.theproposalamendsforthefourthtimeCouncilDirective 76/768/EECof
27July1976ontheapproximation ofthelawsoftheMemberStates
relatingtocosmeticproducts.Itspurpose.istoauthorizetwosubstan­
ces(nicomethanol hydrofluorideand6-methylcoumarin)foruseincos­
meticproductssubjecttocertainrestrictions andconditions (entryin
-AnnexIII). .. ' .1- v-
2.Directive 76/768/EECauthorizes anumberoffluorinecompoundsforuse
inoralhygieneproductsuptoamaximumconcentration of0.5%calcu­
latedasFinthefinishedcosmeticproductandsubjecttocertaincon­
ditionsofuseandwarningswhichmustbeprintedonthelabel.Accord­
ingtothefilesubmittedbythemanufacturer ,nicomethanol hydrofluo-
rideappearstohavesomeadvantageinfixingfluorineontoothenamel
whileat^tl>esametimeithasnotoxicityorpharmacological action
undernormalconditionsofuseandevenbeyond.Itisthereforeproposed
thatitbeaddedtothelistoffluorinecompoundsalreadyauthorized
bytheDirective,underthesameconditions .
3.IntheUnitedStates6-methylcoumarinhasbeenprohibited in'cosmetic
productsbecauseitcaninducephotosensitization reactions.Forthe
samereasontheInternational FragranceAssociation (IFRA)recommends -
that6-methylcoumarinshouldnotbeusedasarawmaterialforperfu­
mery.However,theCouncilofEurope(1)allowsthepresenceof6-methyl
coumarininfoodsuptoaconcentration of30ppm.Asfarascosmetic
1productsareconcerned,.itisthereforeproposedthattheuseof
6-methylcoumarinbeauthorizedsolelyinoralhygieneproducts,where
-thereisnoriskofphotosensitization ,andatamaximumconcentration
of30ppminthefinishedproduct,thelimitauthorizedforfoodstuffs,
whichcorresponds tonormalpracticeintheCommunity.•
>"r ' .." •.
v1)Bluebook.Naturalflavouring substances,theirsourcesandadded
artificialflavouring substances .1974edition.

Indrafti";»theproposal/theCommission obtainedtheopinio"of
nationalexpertsandcor,suitfedindustry ®ndconsumars.
Theproposai .isbasedonArticle100.Consultation oftheEuropean
Parliament andoftheEconomicandSocialCommitteeisrequired.

PROPOSAL FOR ACOUNCIL DIRECTIVE
AMENDING DIRECTIVE 76/768 /EEC
ONTHE APPROXIMATION OFTHE LAWS OFTHE MEMBER STATES
RELATING TOCOSMETIC PRODUCTS
THE COUNCIL OFTHE EUROPEAN COMMUNITIES /
Having regard totheTreaty establishing theEuropean Economic Community ,
and inparticular Article 100thereof , 1
Having regard totheproposal from theCommission ,
Having regard totheopinion oftheEuropean Parliament ,
Having regard totheopinion oftheEconomic andSocial Committee ,
 
Whereas Council Directive 76/768/EEC C1),aslast amended byDirective
79/661/EEC (2),shoul befurther amended totake account oftheresults ofthe
most recent scientific andtechnical research ; -
Whereas according tothese results theuseofnicomethanol hydrof luori de
and 6-methyl coumarin incosmetic products may be-vauthorized under certain
conditions ;
(
HAS ADOPTED THIS DIRECTIVE :
(1)OJNoL262,27.9.1976 ,p.169
(2)OJNoL192,31.7.1979 ,p.35

Article I
ThefollowingsubstancesareherebyaddedtoAnnexIIIPart1toDirec­
tive76/768/EEC:
Ref.
No.Substance RESTRICTIONS Conditions of
useandwarn­
ingwhichmust
beprintedon
thelabelFieldof
application
and/oruseMaximum
authorized·
concentration
inthe
finishedcos-
meticproductOtherlimit­
ationsand
require~
ments
a b c d e f
nicome-
thanol
hydro-
fluorideoral
hygiene
products0.15%calcu-
latedasF.
Whenmixed
withother
fluorine com­
poundsper-
mittedunder
thisAnnex,
totalFcon­
centration
mustnot
exceed0.15%contains
nicomethanol
hydrofluoride
6-methyl
coumariηoral
hygiene
products0.00_%
Article2
TheMemberStatesshallbringintoforcethelaws,regulations andadmin­
istrativeprovisionsnecessarytocomplywiththisDirectivenotlaterthan
30April1982.TheyshallforthwithinformtheCommissionthereof.
Article3
ThisDirectiveisaddressedtotheMemberStates.