ARCHIVES HISTORIQUES
DELACOMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (74)1189
Vol.1974/0190

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COMMISSION OFTHEBTOOEBAN COMMUNITIES
COM(74 )1189 final
Brussels ,25July 1974
Proposaifora
COUNCILDIRECTIVE
ontheapproximation ofthelawsofthe
MealierStatesrestricting themarketing
anduseofcertaindangeroussubstances
andpreparations
(submittedtotheCouncilbytheCommission)
001.1(74 )11RSfinal

EXPLANATORY HEMOIL'JPUM
I.GEEERALOBSERVATIONS
1.Therearealargenumberofdangeroussubstances and.preparalkins
whicharetoxic,noxious,corrosive,irritant,explosiveorreadily
inflammable andwhichmaycausedamagetomanortotheenvironment .
Inordertoprotectthegeneralpublic,andespeciallythosewhouse
them,fromtherisksattachingtodangeroussubstancesandpreparations ,
theCouncil,actingonaproposalfromtheCommission,adoptedon27June19^7
aDirectiveontheclassification ,packagingandlabellingofdangerous
1 .. „ „,2substances ,mostrecentlyrmendedbytheCouncilDirectiveof21Fay1973•
Toprovideevenmoreeffectiveprotectionagainsttherisksattaching
totheuseofdangeroussubstancesandpreparations ,theCounciladoptedon
4June1973a.Directiveondangerouspreparationsusedassolvents3.
Itsubsequently transpiredthatforsemedangeroussubstances and
preparations ,regulations governingclassification ,packagingand
labellingwerenotsufficient ;itwasalsonecessarytoprohibitor
restrictmarketinganduseundercertainconditions .Consequently a
Directivetosupplement Communityprovisionsalreadyexistinginthis
fieldwasnecessary.
SomeMemberStateshaveadoptedprovisionsgoverningvarioussectors
ofthisfield.Theseprovisions showdisparities andthushinderthe
freemovementofgoods.Inordertoeliminatethesebarriers,itis
necessarytoharmonizetheexistingprovisionslaiddownbylav;inthe
MemberStates.
2oAtCo'^inunitylevel,therearealreadyDirectivesguaranteeing
thefreemovementofgoodsandensuringprotectiontohumanhealthand
theenvironment .Theydonot,however,formanadequatebasisforthe
introduction ofgeneralrestrictions onthemarketingoruseof
dangeroussubstancesandpreparations .Thereforeitisnecessaryto
adoptaDirectivecontaininggeneralrestrictiveprovisionsapplying
tofieldswhicharenotcoveredbyotherDirectives,suchasthoseon
OJîlo196,15August,1967.P-1.
OJKoL167,25June1973,P1.
30JKoL169,11July1973,P7-

-2
thecompositionofpetrol(leadcontent),thesulphurlevelsoffuels,
leadandcadmiuminceramicsanddangeroussubstancesinpaintsand
varnishes .
3-TheDirectivewillalsohavetheadvantageofallowingmorerapid
andeffectiveimplementation intheEuropeanCommunityofrestrictions
recommended oradoptedbyotherinternational organizations ,suchas
thedecisionbytheCounciloftheOrganization forEconomicCooperation
andDevelopment (OECD)torestrictproductionandsaleofchemical
productsknownaspolychlorinated biphenyls(PCBs)theuseofwhich
maycontaminate humanhealthandtheenvironment .
4„Thetcsicityandj&rsistence ofPCBswasnoticedforthefirst
timein1966,whentracesoftheseproductswerefoundinpoisoned
fishandwildbirds.Accidentswhichoccurredincludedthe
contamination ofchickensbyPCBspresentinplasticpackagingmaterials,
thediscoveryoffCBs.inwrappings offoodproducts,asaresult«fthe
useofcarbonlesscopyingpaperinthemanufacture ofpaperpulp,and
thepresenceofPCBincow'smilkduetoabsorption bytheseanimals
fromfeeding^tuffs ofPCBsarisingfromherbicidetreatmentorstorage
silos.Inthemostseriousaccidenthumanbeingswerepoisonedasa
result(fixileakageofheattransferliquidinariceoilpasteurization
factoryinJapan.
Forthesereasons,arestriction onthemarketinganduseofPCBsis
necessary.Thustheonlyusestoremainauthorizedwillbethose
containedinacertainlimitativelist,consistingmainlyofcases
wherethenon-inflammable natureofPCBsisanindispensable
characteristic .
5°ThemainpurposeofthefollowingproposalforaDirectiveisto
attainthefollowingobjectivesoftheTreatyestablishing the
Community :
-improvedprotectionofthelifeandhealthofthegeneralpublic,
andinparticularofpersonsobligedbytheiroccupationtobein
contactwithdrngeroussubstances andpreparations ;

-3-
-guaranteeing ofthefreemovementofgoodsintheEuropeanCommunity.
AfurtherpurposeoftheproposedDirective'istohelptoprotectthe
environment andtorestore,maintainandimprovethequalityoflife.
6.ForthesereasonsprovisionismadeforthisDirectivein"both
theCouncilResolutioncf17December1973onindustrialpolicy,andthe
DeclarationoftheCouncilandoftherepresentatives oftheGovernments
oftheMemberStatesmeetingintheCouncil .of22November1973onthe
programmeofactionoftheEuropeanCommunities ontheenvironment.
7-Toleaveopenthepossibility ofextendingthescopeofthe
Directivetootherdangeroussubstancesandpreparations orof
determiningoramendingthedetailsoftherestrictions ,asimpleand
rapidprocedurewasnecessary.Tothisend,theCommitteeonDangerous
Substances,established bytheCouncilDirectiveof21May1973,will
beconsultedwheneverthequestionofextendingoramendingthe
Directivearises.
8.TheproposalforaDirectivehasbeendrawnupwithaviewto
completeharmonization ,whichmeansthatCommunityprovisionswill
replacenationalprovisionsexistinginMemberStates.
Theoompleteharmonization solutionhasbeenadoptedinthiscasehaving
regardtothefactthatthese.substancesandpreparations aredangerous
tohumanbeingsandmaypollutetheenvironment.
9«Finally,theproposedDirectiveisintendedtoencouragemanufacturers
ofdangeroussubstancesandpreparations toreplacethesebyequivalent
productswhicharelessdangeroustohumanhealthandtheenvironment .
II.COMMENTS ONTHEARTICLES
Article 1
ThisgovernsthescopeoftheDirectiveandcontainsdefinitions .The
scopeisrestrictedaslittleaspossibleinorderthat,inthefuture

restrictions maybelaiddovmforallthedangeroussubstancesand
preparations meritingconsideration ,providingthattheserestrictions
arepromptedbyadesiretosafeguardhealthortheenvironment .
Article2
ThisprovisioncompelsMemberStatestocontrolthemarketinganduse
ofthesubstances andpreparations listedintheAnnexinaccordance
withtheconditionslaiddown.
Article3
ThisArticleprovidesforaprocedureforamendingtheAnnextothe
Directiveinthelightoftechnicalprogress.Amendments mustbe
adoptedinaccordancewiththeprocedurelaiddovmintheCouncil
Directiveof27June19^7onapproximation oflaws,regulations and
administrative provisionsrelatingtotheclassification ,packagingand
labellingofdangeroussubstances.
Someoftheexpertsconsultedwereagainstthisproceduresinceunanimous
agreementwouldnotberequiredtosupplementoramendtheAnnex.
Articles4and5
TheseArticlesarecommontoallDirectives .
Anne::
1.TheAnnexcontainsatpresentonlypolychlorinated biphenyls(PC3J
forwhichtherestrictive conditionsarethesameasthoselaiddovmby
theCounciloftheOrganization forEconomicCooperation andDevelopment
(OECD)cn13February1973.

-5-
Thenumber ofsubstances intheAnnex hasbeen reduced compared with
theinitial draft ,fortworeasons .Firstly ,thesubstances removed
from theAnnex will becovered byparticular Directives inwhich theways
andmeans ofrestricting them will begiven andsecondly ,theCommission
departments were notinpossession ofsufficient scientific information
todecide upon immediate restrictions onaCommunity –wide scale .
2.Thepolychlorinated biphenyls (PCB)areagroup ofstable substances ,
consisting theoretically ofmore than 200compounds ,many ofwhich are
wicSLy used ,particularly onaccount oftheir dielectric properties and
their non-inflammable nature .They are atpresent obtained by
chlorination ofbiphenyl ,which '-gives rise tomixtures which are
characterized bytheir mean chlorine contents .Because ofthepersistence
andtoxicity ofsome ofthese compounds ,effects upon theenvironment
have been observed andaccidents which have been reported during the
last fewyears have caused serious misgivings invarious countries .
That iswhypriority hasbeen given tostudying theneed for ,and
possibility of,concerted action toconti'ol theuseofPCBs .
3.According toArticle 2,themarketing anduseofPCBs isprohibited
except forasmall number ofcategories listed intheAnnex tothe
Directive ,that is,"closed systems ".
TheuseofPCBs inclosed systems maybedefined asapplications where
thePCBs arerecoverable .PCBs used intransformers ,large capacitors ,
heat transfer systems ,hydraulic equipment andvacuum pumps arein-.theory .
recoverable because ,while they arebeing used ,they arenotgenerally
dispersed into theenvironment .
III .CONSULT ATIOFOPTHEEUROPEAN "PARLIAMENT AND THEECONOMIC AND SOCIAL COMMITTEE
Itisessential that these twoinstitutions give their opinion inaccordance
with Article 100(2 ).

-1-
PROPOSAL FORACOU1TCILDIPJSCTIVE
ontheapproximation ofthelawsoftheMemberStates
restrictingthemarketinganduseofcertaindangerous
substancesanipreparations
THECOUNCILOPTHEEUROPE:ITCOIIMUHITIES ,
RivingregardtotheTreatyestablishing theEuropeanEconomic
Community ,andinparticularArticleICOthereof ,
HavingregardtotheproposalfromtheCommission :
HavingregardtotheOpinionoftheEuropeanParliament ;
HavingregardtotheOpinionoftheEconomicandSocialCommittee :
Whereasanyrulesconcerningtheplacingonthemarketofdangerous
substancesandpreparations mustaimatprotectingthepublic,and
inparticularworkersusingsuchsubstancesandpreparations ;.
Whereastheyshouldalsocontributetotherestoration ,preservation
andimprovement ofhumanlifeandtotheprotectionagainstrisks
tohealthcausedbyenvironmental pollution ;
Whereasdangeroussubstancesandpreparations aregovernedbyrules
intheMemberStates,andwhereastheserulesdifferastothe
conditionsoftheirmarketinganduse;whereasthesedifferences
constituteanobstacletotradeanddirectlyaffecttheestablishment
andfunctioning oftheCommonMarket;
Whereasthisobstacleshouldthereforeberemovedandwhereasthis
entailsapproximating theexistingrelevantlawsintheMemberStates;
Whereastheprovisionsrelatingtocertaindangeroussubstances
andpreparations havealreadyboonprovidedforinComnunit-rcHroctiv^r :
whereasitisstillnecessarytolaydownrulesforotherproducts;
inparticularforthoseforwhichinternational organization have
establishedrestrictions ,forexample ,theCounciloftheOECD
•••/•••

decidedon13February1973therestriction oftheproductionand
useofthepolychlorinated biphenyls(PCB).Thisprovisionwas
necessarytopreventtheabsorptionofthePCBinthehumanbody
andtheresultantdangertohumanhealth,
MSADOPTEDTHISDIRECTIVE :
Article1
1.Withoutprejudicetotheimplementation ofotherrelevant
Communityprovisions ,thisDirectiveisconcernedwith
restrictingthemarketinganduseofcertaindangeroussubstances
andpreparations intheMemberStatesoftheCommunity,and
inparticularthosewhichpresentcharacteristic ofecotorcicit'y ,
2.ThisDirectivedocsnotapplyto:
(a)thecarriageofdangeroussubstancesandpreparations
byrail,road,inlandwaterway,seaorair;
(b)dangeroussubstancesandpreparationsexportedto
non-membercountries;
(c)substancesandpreparationsintransitandsubject
tocustomsinspection,providedthattheyundergo
noprocessing.
3.ForthepurposesofthisDirective:
(a)"substances"means
Chemicalelementsandtheircompoundsastheyoccurin
thenaturalstateorasproducedbyindustry;
(b)"preparations"means
Mixturesorsolutionscomposedoftwoormoresubstances.
•••/•••

–3–
Article2
MemberStatesshalltakeallnecessarymeasurestoensurethatthe
dangeroussubstancesandpreparations listedintheannexandsubject
totheconditionsspecifiedthereincannotbeplacedonthemarket
orused,exceptforpurposesofresearchoranalysis.
Article3
Theamendmentsrequiredtoadapttheannexintheli/jhtoftechnical
progressshallboadoptedinaccordancewiththeprocedurelaiddown
inArticle8coftheDirectiveof27June1967("7/54->f)cvncarninrfther.pproj.:imtionoflaws,regulationsrjailculoinistrevtiva'pxvsrisionsrelwiiiv?'totheclassification .p">,c!c%ging ••ry\l;,,'b3lliiv»of•TnnLj,ercu8sul.stuices.aslastlastanenC-od "bytheDirectiveof21May1973(73/14Vine).
."xtiole4
-1.MemberStatesshalladoptandpublishthemeasuresneeded
inordertocomplywiththisDirectiveby1January1976
andshallforthwithinformtheCommissionthereof.They
shallapplytheseprovisionsfrom1October1976,
2.Onnotification ofthisDirective,MemberStatesshall
informtheCommission,intimetoenableittoputforward
itscomments,ofalldraftlaws,regulationsoradministrative
provisionswhichtheycontemplateadoptinginthefield
coveredbythisDirective.
Article5
ThisDirectiveisaddressedtotheIfemberStates.

ΔΜΊΞΧ
Designation ofthe substance or
preparation orgroiips ofsubstances
1.Polychlorinated Biphenyls(PCl )Conditions ofrestriction
Maynot beused except forthe
following :
Dielectric fluids for transformers
orlargo power factor correction
capacitors (^1kg);
Heat transfer fluids (other than
ininstallations forprocessing
offoods ,drugs ,feeds and
veterinary products );
Hydraulic fluids inmining
equipment ]
Small capacitors (1legand
42%CL )■