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COMMISSION OFTHEEUROPEAN COMMUNITIES
> COM(76)433 final
Brussels,8September 1976
\
■,/I:
/ s
•\
Proposalfora
COUNCILDIRECTIVE
I
thesixthmodification oftheCouncilDirectiveof
27June1967ontheapproximation ofthelawsof^/
* . )MemberStatesrelatingtotheclassification ,
packaging andlabellingofdangeroussubstances
!
(sybmitted bytheCommissiontotheCouncil)
(
?
ι
C0MC76)433final
/

EXPLANATORY liEIORABIOM
1.IFTRODUCTION
Duringohepastfewyears,thelargescalechangesinthechemical
industryhaveledtoarapidincreaseinboththenumberandquantity
ofsyntheticchemicalcompoundswhichhasinturngivenrisetomore
andmoreseriousproblemswithrespecttotheircontrol.
Chemicalcompoundsnowhaveaplaceinmosthumanactivitiesandeach
yearthelistlengthens.Thereisariskthatamongthesecompounds
theremaybesubstanceswhichcouldhaveharmfuleffectsdirectlyor
indirectlyformanandtheenvironment.
AtthemomentonaCommunitybasisthisisregulatedbytheCouncil
Directiveof27June1967(67/548/CES)ondangeroussubstanceswhich
laysdownconditionsfortheirclassification andthewayinwhich
theyareofferedforsaleaswellasbyCouncilDirectivesonsolvants
(73/173/CEE,detergents(73/404/CEH)andmethodsofmeasurementofthe
biodegradibility ofanionicsurfactants (73/405/CE3).
Otherdirectivesoncertainpreparations areincourseofadoption.
Todayscientificcircles,publicopinionandtheaiithoritiesofIfember
Statesareconfrontedincreasingly byproblemscausedbytoxic,harmful
orpollutingsubstances.Polychlorbiphenyls (PCB),polychlorterphenyls
(PCT),vinylchloridemonomer(VCM),mercprycompounds,andcertain
organohalogen compoundsarethemostcurrentexamples. „
Adirectiveonthelimitationoftheplacingonthemarketandus.•of
thefirstthreesubstanceswasapprovedbytheCouncilon30June1$)57«
Thisdirectiveisnotlimitedtothesethreepollutantsitincludesthe
possibilityofextensionofitsfieldofapplicationtoanychemical
substancewhichmayprovetobedangerous.

-2-
Inviewofthegrowingconcernofpublicauthoritiesthereisnowincreased
interestinthedifferentwaysofevaluatingtheeffectsofchemicalproducts
■beforetheseofferarealdangersothatthisdangercanbeavoidedasmuch
aspossible.
Itseemsmoreandmorenecessaryatthemomentnottocontinueplacingon
themarketchemicalcompoundspotentially dangerousformanandtheenviron­
mentwithouthavingavailableaminimumofknowledgeabouttherickswhichr
areproduced.Bythenatureandimportanceofthesolutionsandtheirimpact
ontradeandthefreecirculationofgoodsthisproblemcouldonlybesolved
onaCommunitybasisnotablybecauseofthefundamentalobjectivesofthe
EuropeanEoDnomicCommunityandinparticularbecauseofthemeasuresarising
fromtheexistenceofthedirectiveof27June1967.
IneffectbytheEuropeanCommunityActionProgrammefortheEnvironmentof
22November'1973theCouncilhaschargedtheCommissiontoexaminethe
possibilities ofharmonizing andreinforcingthecontrolwhichthepublic
authorities shouldexerciseoncertainnewsyntheticsubstancesandproducts
beforetheyareplacedonthemarket.
Thisexamination hasshownnotonlythenecessityofsettingupasystem
ofcontrolbutequallyofestablishingthiswithaviewtopreventing
pollution,inaccordancewiththefirstprincipleoftheEnvironmental
PolioyProgrammepreviouslymentioned,andtoundertakethisinasystematic
way,thatistosaybyageneralisedcontrol.
InJune1975"thisFrenchGovernmentinaccordancewiththeinformation agree­
mentonenvironmentof5March1973»notifiedtotheCommissionadraftlav;
onthecontrolofchemicalproductsdispersedintheenvironment.The
CommissioninvitedtheFrenchauthoritiestopostponetheapplicationof
themeasuresenvisagedinorderthatitcouldprepareproposalsforCommunity
measurestobepresentedtotheCouncil.Thepreparatory worktvascarried

outwiththehelpofthegroupofnationalexperts"Eliminationoftechnical
"barrierstotrade:dangeroussubstances".Threeplenarymeetingsandone
restrictedmeetingwereheldtoexaminethedraftmodification ofthe
directiveof27June1967.
Inparallelwiththisworkofmodification ofthedirectiveof19^7to
includethecriteria"dangerousfortheenvironment"theCommitteefor
Ado.ptc.tiontoTechnicalProgressunanimouslyvotedamodification of
Anne."03I,IIIandIVofthisdirectiverespectively tothelistof
dangeroussubstancesindicationsofriskandsafetyadvice.
Thepresentproposalofmodification ofthedirectiveof27June1967
envisagesthereinforcement ofmeasuresrelatingtotheclassification ,
packagingandlabellingofsubstanceswhichhadasitsobjectivethei>
protectionofusersandworkers.
Inordertosupervise *"theeffectsonmanandtheenvironment ,itis
proposedthatanyplacingonthemarketofanewsubstancewouldimply
thecarryingoutofapriorstudybythemanufacturer andnotification
tothecompetentauthorities whenthesubstancewasfirstplacedonthe
marketinaMemberState.Tofollowcloselytheevolutionofsubstances
placedonthemarketandtheiruse,asystemshouldb&osot'upwhich.-provides
for,'the!'.listing!of.rail/nowsabstakcels which.'are-'<plac&iiooarthe'.;n&a?lcBi.
...•/.:•<_tov.:>.
Inthisway,thecompetentauthorityofaMemberStatewillbeinaposition
toevaluatetheconsequences whichwouldresultfromthemarketingofthe
substanceandcouldifnecessaryinterveneimmediatelyinmodifyingthe
classification proposaleitherbylimitingorforbiddingthemarketingof
thesubstance.
Thislimitationorprohibition wouldtakeplacewhentheoompetentauthority
judgedittobenecessaryandindispensible fortheprotectionofmanand
theenvironment .
V.

-4-
Thepresentproposalofdirectivehasasitsobjectivethelayingdownof
Communitymeasuresinthefieldofchemicalproductsinviewoftheir
dangerformanandtheenvironmentandisanaturalsequeltodirectives
elaboratedinthefieldofdangeroussubstancesandpreparations .
Inordertofacilitatethereadingofthedirectiveanewnumberingof
theartiolesisproposed.

-5-
ItisproposedtoreplaceArticles 1to11oftheCouncilDireotiveof
TV£7Juno-1§67bya-newi^oxtj,; •;•
COimiTARIES ONTHEMA.HTMODIFICATIONS ENVISAGED–'– ■ ■■
Article T
Thefieldofapplicationofthisarticlehas"beenenlargedtoinclude
thenotification ofnewsubstances.Thenewsub-paragraph 2astates
thatsubstancesusedasfoodstufforanimalfeedingstuffs aresubmitted
tootherCommunitymeasureswithrespecttotheirlabelling.
Article2
InArticle2(c)(d)and(e)thedefinitionsofnewsubstancesand
notificationaregiven.Inparagraph2(i)a^newclassification
1dangerousfortheenvironment *iscreatedtotakeaccountofthe
newobjectivesofthedirective.
Article3
Thenewparagraphs 2and3ofthisarticlespecifythemethodof
determiningtheclassification envisagedbythedirectiveandrefers
totechnicalannexesVI,VIIandVIII.
Article5
Thisarticlefixesthegeneralconditions ifcwhichnewsubstancesmust
besubmittedtobeplacedonthemarket.
Article6
Thisarticlesetsoutthegeneralprincipleaocordingtowhichthe
notifiermustcarryoutapriorstudywiththeaimofassessingthe
effectsonmanandtheenvironmentofthenewsubstance.Itobliges
himtocommunioateacertainnumberofindispensable resultsfrom
theexaminationofthenowsubstance.Paragraph3inparticular
envisagesacontinuityofinformation.

-6~
Article7
Thisartioleenvisages "thenominationofcompetentauthoritiesinfixing
theframeworkoftheirresponsibilities withregardtothemarketingof
anewsubstance.
Article3
Thisartioleliststhesectorsexcludedfromthenotification procedure.
Thisexclusionisnecessaryeithertooovertheneedsforresearchorfor
otherCommunitymeasures.Articles9»1°and11setuptheCommunity
notification procedure.
Article14
Theprincipalmodification ofthisarticleisatsub-paragraph 2cwhich
unicestheuseofsafetyadviceobligatory.Itshouldalsobenotedthat
thenewparagraph5envisagesthattheindicationsenumeratedatparagraph
2must,wherenecessary,beaccompaniedbyappropriateinscriptions
decidedbyapplicationofArticle7in"theframeworkoftherequirements
relatingtoconditionsofuse.
Article15
Toparagraph 1anewmorecompleteformatisproposedaccordingtothe
capacityofthepackage.
Article21
Paragraph 1enlargesthescopeofthesafeguardclauseinthecasewhere
aMemberStatedeemsthattheinformationnotifiedaccrodingtoArticle
6areolearlyfalse.
/•

-7-
AnnexvI
Characteristics forassessmentofdangerfortheenvironment whichisoffered
"bysubstances.
Anne::VIT
CharacteristicsformingpartofthetechnicaldossierenvisagedinArticle6.
:VUT
Determination oftheapplicability ofthecategoriestoxic,harmful,corrosive
andirritant.
III,CONSULTATION OFIMEH3STED PARTIES
Theproposalofdirectivewaswritteninconsultation withaWorking
Groupofexpertscompetentinthefieldofpublichealth,ofthe
t;rrvironmfirrtandofhealthandsafetyatworkandwithwhichrepresent­
ativesoftheconsumersandtheappropriateindustrialsectorwere
associated .
IV.CONSULTATIONOPTHEEUROPEANPARLIAMENT ANDTHEECONOMIC ANDSOCIAL
comms
InapplicationofArticle100,paragraph2oftheTreaty,takingiirbo
accountthefactthattheapplicationofthisdirectivewillrequire
modifications tothelegalprovisionsofMemberStates,theopinion
oftheEuropeanPar?.iamentandtheEconomicandSocialCommitteeis
nocessary .

PROPOSAL FORACOTOTCILDIRECTIVE
thesixthnodification oftheCouncilDirectiveof
27«6.T9'67ontheapproximation ofthelawsofMembor
Statesrelatingtotheclassification ,packingand
labellingofdangeroussubstances
TKSCOUNCILOPTHEEUROPEAN COMMUNITIES
IiavingregardtotheTreatyestablishing theEuropeanEoonomicCommunity,
andinparticularArticle100thereof
HavingregardtotheproposaloftheCommission
Iiaviivg'regardtotheOpinionoftheEuropeanParliament
HavingregardtotheOpinionoftheEconomicandSocialCommittee,
tuiereastoprotectmanandtheenvironmentagainstpotentialriskswhich
couldarisefromtheplacingonthemarketofnewsubstances,itis
necessarytolaydownappropriate measuresandinparticulartoreinforce
thecontrolsenvisagedinCouncilDirective67/54&/CEEof27Juno1967on
theapproximation oftholegislative ^regulatoryandadministrative measures
relatingtotheclassification ,packingandlabellingofdangeroussubstances
(1)modifiedmostrecently "byDirective75/409/CEE(2),
Wheres.3itisnecessaryforthesereasonstomodifytheDirective67/54-8/CEE
xvhichatthemomentbyaclassification ,packingandlabellingofdangerous
arubstanoenprotectsthepopulationandprincipallytheworkersusingthem;
Whereasinordertocontroltheeffeotsoncanandtheenvironmentitis
advisablethatanynewsubstanceplacedonthemarketissubjectedtoa
priorstudybythemanufacturer andanotification tothecompetentauthor­
itiesconveyingmandatorilycertaininformation ;andwhereasitis,moreover,
importanttofollowcloselytheevolutionanduseofnewsubstancesplacedon
themarket,andthatinordertodothisitisnecessarytoinstitutoa
systemwhichallowsallnewsubstancestobelisted;
Uhereasitisnecessarytoenvisagemeasuresalloi/ing^theCommissionto
introducetheprocedureofnotification toallthel-IemberStates;andwhereas
itis,moreover,necessarytoenvisagethatthemeasuresrelatingtothe
classification ,packingandlabellingandtheconditionsofuseofnew
substancesmaybelaiddownattheCommunitylevelbyDirectivesofthe
CommissionorCounoilasappropriate ;
(1)GJ3STo196,16.3.1967,P.1
^2)ajÎTOL103,14.7.1975,P»22

WhereasthecompetentauthorityofaMember -Stat-emastbeinaposition
toappraisetheconsequencesresultingfromtheplacingonthemarketof
anewsubstanceandmay,inherenecessary,interveneinlimitingorin
prohibitingtheplacingonthemarketoftheaforementioned substance
whenitjudgesthisto"benecessaryfortheprotectionofmanandthe
environment ;
Whereasitisnecessarytomakeitobligatorythatsafetyadviceaccompanies
thepackingofdangeroussubstances ;
WhereasArticle2oftheabovedirectiveclassessubstancesandpreparations
astoxic,harmfulorcorrosivebytheuseofgeneraldefinitions ;whereasin
theibsence,atthemoment,ofspecifications allowingtheirallocationto
theseclasses,itseemsappropriatetoenvisageprecisecriteriaforclassi­
fication;whereasinadditionArticle3ofthedirectiveenvisagesanevalua­
tionofdangerfortheenvironment andthatarisingfromthisitisnecessary
toenumerateoertaincharacteristics andparametersofassessment;
Whereasforthebetterunderstanding ofthedirectiveanewpresentation and
adifferentnumberingofthearticleshavebeennecessary.
ΤΓΛΪ3?Γ:ΐαΤΓΓΊ
HASADOPTEDTHISDIRECTIVE
Article 1
»•Articles 1totloftheCounoilDirectiveof27June19&7relatingto
theapproximation oflegislative,regulatoryandadministrative
measuresconcerningtheclassification ,paolcagingandlabellingof.
dangeroussubstances(67/MS/EEC)modifiedinthelastinstanceby
Directive75/409/SECarereplacedbythefollowingartioles:

_3-
"Article 1
1.Thepurposeof"thisDirectiveistoapproximatethelaws,regulations
and.a&ministrativeprovisionsoftheIJenberStateson:
-notification ofnewsubstances
-classification
••pr.c]caging,and
51'r/*
ofsutstancesdangerousformanandtheenvironment whichareplaced
onthemarketintheIfemberStatesoftheCommunity.
2.ThisDirectivedoesnotctqjs&ljrrtothe provisionsrelatingto:
a)medicinalproducts,narcoticsandradioactivesubstances;
b)thecarriageofdangeroussubstancesbyrail,road,inland
waterway,seaorair;
c)munitionsandobjectscontainingexplosivematterintheform
ofignitersormotorfuSls:
d)adtii-jtéyss orCiitåMlDQalt;feédl2igErh^fs;cc :io:r.•il?..
•^.•"i•1-•-n r» ^-*,*r.*•»■?•.•.•*L,>*h *.*v/**e•voS •'4,*.,1..SUi.'J ...c*..i\*
o-t.:*-Ci*•••.•.yd.',r.'iv'sotivoe ».•*':
3.Theclassification ,packagingandlabellingprovisionsofthisdirective
donotapplytodangeroussubstancesexportedtothirdcountries.
4«Articles13to15ofthisDirectivedonotapplytocontainersfor
gaseswnicharecompressed,liquefiedordissolvedunderpressure.
•/

Article2
ForthepurposeofthisDirective :
a)*substances'moans
chemicalelementsandtheircompoundsastheyoccurinthenatural
stateorasproducedbyindustry;
b)preparations' means
mixturesorsolutionscomposedoftwoormoresubstances ;
c)'newsubstances'
substanceswhichhavenotpreviouslybeenplacedonthemarket
eitherasasubstanceormixturebefore3aizaaa?y,i97§~ *-
,'jr''3withtheexceptionofthosemadeavailabletoresearch
laboratories .
d)environment
Water,air,earth,biologicalforms;therelationbetweenthem
andwithman.
e)notification
Aninformativedeclarationtothecompetentauthoritybythe
manufacturer oranyotherpersonplacinganewsubstanceon
Nthemarket,hereaftercalledthenotifier.

Thefollowingsubstancesandpreparations are'dangerous 1withinthe
meaningofthisDirective:
a)explosive
substancesandpreparations whichmayexplodeundertheeffectof
flameorwhicharemoresensitivetoshocksorfrictionthandini-
trobenaene ;
b)o:ridising
substancesandpreparations whichgiverisetohighlyexothermic
reactionwhenincontactwithothersubstances,particularly flam­
mablesubstances ;
c)easilyflammable
-substancesandpreparations whichmaybecomehotandfinallycatbh
fireincontactwithairatambienttemperature withoutanyapplic­
ationofenergy,or
-solidsubstancesandpreparations whichmayreadilycatchfireafter
briefcontactwithasourceofignitionandwhichcontinuetoburn
ortobeconsumedafterremovalofthesourceofignition,or
-liquidsubstancesandpreparationshavingaflashpointbelow21°C,
or
-gaseoussubstancesandpreparations whichareflammableinairat
normalpressure,or
~substancesandpreparations whichincontactwithwaterordampair,
evolvehighlyflammablegasesindangerousquantities ;
d)flammable
liquidsubstancesandpreparationshavingaflashpointbetween21°C
and55°C;
e)toxic
substancesandpreparations which,iftheyareinhaledortakeninter­
nallyoriftheypenetratetheskin,mayinvolveserious,acute.or
chronichealthrisksandevendeath;
/

f)harmful
substancesandpreparations which,iftheyareinhaledortaken
internallyoriftheypenetratetheskin,mayinvolvelimited
healthrisks:
g)corrosive
substancesandpreparations whichmay,oncontactwithlivingtissue3,
destroythem;
h)irritant .
non-corrosive substancesandpreparations which,throughimmediate,
prolongedorrepeatedcontactwiththeskinormucousmembrane,can
causeinflammation .
i)dangerousfortheenvironment
substances,theuseofwhichpresentsorcouldpresentimmediateor
prolongedrisksfortheenvironment .
Article3 .
1.Theflashpointoftheflammableliquidsubstancesandpreparations
mentionedinArticle2paragraph2(c)and(d)shallbedetermined
accordingtothemethodsandwiththeapparatuslaiddowninAnnexV.
2.Theenvironmental orpotentialenvironmental hazardshallbedetermined
inaccordancewiththecharacteristics setoutinAnnexVIItakinginto
accounttheparametersof;appreciation containedinAnnexVI.
3.Thedetermination ofthecategoriestoxic,harmful,corrosiveand
irritantmentionedinArticle2,paragraph2,e),f),g)andh)asis
carriedoutaccordingtotheoriteriainAnnexVIII.

-7-
Article4
Theclassification ofdangeroussubstancesaccordingtothodegreeof
hazardandspecificnatureofrisksshall"bebasedonthecategories
laiddowninArticle2(2).Forcategories(a)to(h)thesubstanoes
shall"beolassifiodacoordingtothegreatestdegreeofhazard#
1»MemberStatesshalltakeallthenecessarymeasurestoensurethattho
nowsubstancesreferredtoinArticle2arenotplacedonthemarket
unlesstheyhavebeen:
~notifiedtothecompetentauthorityinaccordancewith
thisdirective;
-paokagedinaccordancewiththeprinciplesofArt.13;
-labelledinaccordancewiththeprinciplesofArt.14;
2.These Ci.:5..-n::arevaliduntilthesubstanceislisted
intoAnnexI.PromthetimethesubstanceislistedinAnnexIit
mustbei
~packagedaccordingtoArt.13;
-labelledaocordingtoArt.14;
~andusedunder.theconditionswhich,whennecessary,have
beenlaiddowninrespectofitinAnnexI.
Artiole6
1.Thonotifierisrequiredtocarryoutastudypriortomarketinganow
substancetoenpb^e.itseffectsonmanandthoenvironment tobo
Siibiniir
assessedandtotothecompetentauthorityenvisagedinArt.7»
atthelatestonthedateofmarketing,anotification with.'.art'
acknowledgement ofreceiptinoluding:.

η–fjmm
–atechnicaldossiercontainingalltheinformationnecessaryto
evaluateforseeabledirectorindirectriskswhichthenewsubstance
mightentailformanandtheenvironmentinrespectofthevarious 1
usesenvisagedandwhichcontainsatleastcommentsrelatingtothe
characteristics listedinAnnexVIIwhichhearanasterisk.
–adeclaration concerningtheunfavourable effectsofthesubstance;
-theclassification andlabellingofthesubstanceinaccordance
withthisdirective ;
-proposalsforanymeasuresrelatingtotheconditionsofusewhich
areintendedtolimittheunfavourable effects.
2.Thenotifiermayatthesametimesendacopyofthedossiertothe
Commission *
3.Thenotifierisfurtherrequiredtoinformthecompetentauthority
ofanysignificant changeinoradditiontotheinformationpreviously
notifiedinparticularinrelationto:
-newusesforwhichhemarketsthesubstance(seeAnnexVII,para2.1)
-annualincreasesinthequantitieswhichhemarkets(seeAnnexVII,
para2.2)
-toxicorecotoxiccharacteristics notpreviouslynotified.
Article7
1.LieinberStatesshallappointacompetentauthority(orauthorities)
whoshallberesponsiblefor:
-receivingthenotification andexaminingitsconformitywiththe
prescriptions ofthedirective; j
-examiningtheforseoablerisksthatthesenewsubstancesmightgive
riseto;
-examiningtheclassification andlabellingproposal;
-examiningtheproposalsofmeasuresrelatingtotheconditionsof
use;

Moreover,iftheauthorities seefittheymay:
-askforfurtherinformationand/orverificationtests;
-carryoutsuchsamplingasisnecessaryforcontrolpurposes}
-takeappropriate measuresrelatingtoconditionsofusewhile
awaitingCommunitydispositions *
"ccs'o>:thq?pioDCftiirscïUiid-daraiiL'i#'ArtxaiooJ■$£±t^j?ropb&alg Sor
io...-*.v ov tropea.*.*3i.cr:
-classification
~labelling
-dispositionsrelatingtoconditionsofuse.
MemberStatesandtheCommissionshallensurethatanyinformation
concerningmarketingormanufacturing shall "bekeptsecret.
Article3
Substancesinasmuchastheyareplacedonthemarketinthefillow-
ingwaysshall"beexcludedfromthenotification procedure :
a)forresearch,developmentoranalysis;
b)a3substanceorinmixturesfor:
-spécialpharmaceuticalproducts
–components-'"of'iaafisjpisiisorobjectsintendedtooomeinto
-•contact';with J'
»■*.^Γ·τ,ΛV-ιΛ.-······-»·ι,3■»"·.ΛΛ.Τ·.· »"Ι";»<■·%>·»■!··.··.·*'"■'*·Λι·»·,"·»»·'*·Ι.Λ..ν.^.·λ.ο.Λ.ν·.ι..Λ~^. ..«.·!*·»..·«„-..ο..ο.––donpoS^jixsorpestioides"'subjected~*totypeapproval""
.»"**1,"'ir*. »il-1V*'( •4J*»V*f.4»>..•'y,V*'k1,... .'.V./ii+.*" ivAwi•<>•,WV•
-cosmeticproducts.

-10-
Article9
AMemberStatewhichhasreceivedthenotification dossieror
additionalinformationenvisagedinArticle6shall\1'.:?:oh.2
■.oiitC-*Aths:v-;-:v."..-;rsendacopyofitimmediatelytothe
Commissiontogetherwithanyrelevantcomments.
Article10
Onreceiptofthecopyofthenotification dossierorsomeother
complementary information fromaMemberState,theCommissionshall
transmit:
~theelementsofthenotification totheotherMemberStates;
–anyrelevantinformation whichithasgatheredtoallMemberStates.
Thistransmission shallhadeemedtoconstitute anotification tothe
competentauthorities ofotherMemberStateswithinthemeaningof■.
Artiole6.
Article11
1.TheCommissionshallkeepatthedisposaloftheMemberStatesacata­
logueofallsubstancesnotifiedunderthisDirective.
2.ThoMemberStatesmaybecalledupontogivetheCommissionanyinfor­
mationnecessarytoup-datethiscataloguenotablyinrespectofquanti­
tiesplacedonthemarket.
Article12
AnnexIofthisDirectivecontainsthelistofsubstancesclassified
undertheprovisionsofArticle4andwhereappropriatedispositions
relatingtoconditionsofuse.
.•/.

-11-
Article13
MemberStatesshalltakeallnecessarymeasurestoensurethat
dangeroussubstancescannotbeplacedonthemarketunlesstho
strengthandimpermeability oftheirpackagingsatisfiesthe
followingrequirements ,anypackagingmeetingtheserequirements
beingregardedasadequate:
1.±'hcpac':agingsmustbesoarrangedandfastenedastoprecludeany
lossofthecontents;thisrequirementdoesnotapplywherespecial
safetydevicesareprescribed ;
-2.Thematerialsconstituting thepackagingandfasteningsmustnotbe
liabletoattackbythecontents,orliabletoformharmfulor
dangerouscompoundswiththecontents;
2,1,Thepackagingandfasteningsmustbestrongandsolidthroughoutto
ensurethattheywillnotloosenandwillsafelymeetthenormal
stressesandstrainsofnormalhandling.
'Article14
1„MemberStatesshalltakeallnecessarymeasurestoensurethatdangerous
substancescannotboplacedonthemarketunlesstholabellingontheir
packagingsatisfiesthefollowingrequirements .
''2.Everypackagemustshowclearlyandindeliblythefollowing s
~thenameofthesubstance .
–theoriginofthosubstance,
~thodangersymbol,whenlaiddown,andindicationofdangerinvolved
intheuseofthosubstance,,
-areferencetothespeoialrisksarisingfromsuchdangers;
a)thenameofthesubstancemustbooneofthetermslistedinAnnex
ItothisDirective;
b)theindicationoforiginmustincludethenameandaddressofthe
manufacturer ,the-distributorortheimporter;
•/.

-12-
c)thkfollowingsymbolsandindicationsofdangeraretobeused:
-•explosive :anexploding "bomb(E)•
-oxidising :aflameoveracircle(o)
-vary.flammable . ':aflame(F)
-toxic :adeath'sheadandcrossbones
-harmful :aSt.Andrew*sCross(Xn)
-ooii'csive :thesymbolshowingthedanr.gin-j
effectofanyaoid(C)
«irritant saSt.Andrew1sCross(Xi)
ThesymbolsmustconformtothoseinAnnexIItothisDirective;
theyshallbeprintedinblackonanorange-yellow background.
d)Thenatureofthespecialrisksinvolvedinusingthesubstances
matbaindicatedbyoneormoreofthestandardphraseswhich,in
conformitywiththereferencescontainedinthelistinAnnexI,are
sotoutinAnnexIIItothisDirective.
<•£)Thepackagingshallbeacoompaniedbysafetyadvicerelatingtothe
useofthesubstanceswhereitismateriallyimpossiblefortheseto
begivenonthelabelorpackageitself.Thewordingofsuchpre­
cautionsste.ll,inconformitywiththereferencescontainedinthe
listinAnnexI,bebasedonAnnexIVtothisDirective.
3.Forpackagesofharmful,irritant,highlyflammable,flammableand
oxidisingsubstances,indicationneednotbegivenofspecialrisks
andEafetyadvicewherethepaokage 'containsnomorethan125ml.
4.Whenmorethanonedangersymbolisassignedtoapreparation :
-theobligationtoindicatethesymbolTmakes,ingeneral,the
symbolsXand0optional;
-theobligationtoindicatethesymbolCmakesthesymbolXoptional;
-theobligationtoindioatothesymbolSmakesthesymbolsFand0
optional.

-13-
5.Thoindicationsmentionedinparagraph2must,wherenecessary,"be
accompanied "byappropriateindicationsrequiredinapplicationof
.Article7withrespecttomeasuresrelatingtoconditionsofuse.
Article15
1.ITnentheparticularsrequired "byArtiole14appearonalabel,the
lattermust"beplacedononeormorefacesofthepackagesothat
itcanbereadhorizontally whenthepackageisputdownnormally.
Thedimensionsofthelabelmust"boasfollows:
Packagecontent Dimension
~lessthanorequalto0.5litres:ifpossible,52x74nm
atleast
-groatorthan0.5litres,andnot
exceeding 1litre :atleast 74x105mm
~greaterthan1litre,andnot
exceeding10litres :atleast .105x14^mm
-greaterthan10litres,andnot
exceeding50litres :atleast 140x210mm
-greaterthan50litres :atleast 210x2J6mm
Eachsymbolmustooveratleastone-tenthofthesurfaceofthelabel
2andbeatleast1cm.Theentireareaofthelabelmustadheretothe
packageimmediatelycontainingthesubstance.
2.Alabelisnotrequiredwherethoparticularsareclearlyshownon
thoimmediatepackage,asspecifiedinparagraph 1.
3.Theoolourandpresentation oftholabel–orinthecaseofparagraph
2,ofthepackage-mustbesuchthatthedangersymbolstandsout
clearlyfromthebackground.
4.MemberStatesmaymakethepla6ingonthomarketofdangeroussubstances
intheirterritoriessubjecttotheuseofthenationallanguageor
languagesinrespectofthelabellingthereof.

-14-
ForthepurposeofthisDirective,labellingrequirements shall "bo
deemedto"bosatisfied :
a)inthecaseofanouterpackagecontainingoneormoreinner
packages,wheretheouterpaokageislabelledinaccordance
withinternational rulesonthetransportofdangeroussubstances
andtheinnerpaokageorpaokagesorelabelledinaccordancowith
thisDirective;
b)inthecaseofasinglepackage,wheresuchapackageislabelled
inaccordancewithinternational rulesonthetransportofdangerous
substancesandwithArtiole14(2)(a),(b)and(d).
Inthecaseofdangeroussubstances,whichdonotleavethesovereign
territoryofaMemberState,labellingmaybopermittedwhichcomplies
withnationalrulesinstoadofwithinternational rulesonthotrans­
portofdangeroussubstances.
Article16
MemberStatesmay:
a)permitthelabellingrequiredbyArticle14toboappliedinsome
otherappropriate manneronpackageswhichareeithertoosmall
orotherwiseunsuitabletoallowlabellinginaccordancewith
Article15.
b)bywayofderogationfromArticles14and15,permitthepackaging
ofdangeroussubstanceswhicharoneitherexplosivenortoxicto
beuniabelled ,ortobolabelledinsomeotherwayiftheyoorrtain
suohsmallquantitiesthatthereisnodangertoworkersorothers.
Articlo17
-TheamendmentsnecessarytoadaptthoAnnexestotechnicalprogress
shallbeadaptedinaccordancewiththeprocedurelaiddowninArtiolo
19

-15-
Article18
1.ACommittoeshall"boestablishedfortheadaptationtotechnicalprogress
ofDirectivesforremovingtechnical "barrierstotradeinthesectorof
dangeroussubstancesandpreparations ,hereinaftercalled'Committee *,;
whichshallconsistofrepresentatives oftheMemberStatesundertho
Chairmanship ofarepresentative oftheCommission.
2.TheCommitteeshallestablishitsinternalregulations.
Article19
1.Intheeventthatreferenceismadetotheprocedurelaiddowninthis
Article,themattershall"boreferredtotheCommittee "bytheChairman,
eitheronhisinitiative,oratthorequestoftherepresentative ofa
MemberState,
2.Therepresentative fromtheCommissionshallsubmitadraftoftho;■
measuresto"betakentotheCommittee.ThoCommitteeshalle:cpressits
.OpiniononthisdraftwithinaperiodspecifiedbythoChairmaninthe
lightoftheurgencyofthematterinquestion.Amajorityof41votes
shallsufficeforaDecision,thovotesoftheMemberStatesbeing
woightedaslaiddowninArticle143subparagraph 2oftheTreaty.
"'TheChairmanshallnotvote.
3.a)TheCommissionshalladaptthemeasuresenvisagedwhentheyarein
accordancewiththoOpinionoftheCommittee."
b)WhenthemeasureshavenotbeenagreedonbytheCommittee,orin
theabsenceofanOpinion,thoCommissionshallsubmittotheCouncil
withoutdelayaproposalonthomeasurestobetaken.TheCouncil
shallgivejudgementbythequalifiedmajority.
o)If,afterthematterhasbeenbeforetheCouncilforaperiodof
threemonths,therehasbeennodecisionbytheCouncil,tho
proposedmeasuresshallbeadoptedbythoCommission.

-16-
Article20
I&mtarStatesshallnotprohibit,restrictorimpedeonthegroundsof
notification ,classification ,-packagingorlabellingasdefinedinthis
Directive,theplacingonthemarketofdangeroussubstanceswhich
satisfytherequirements ofthisDirectiveandtheAnnexthereto.
Article21
1.WhereaMemberStatehasdetailedgroundsforestablishingthata
dangeroussubsta.nce,althoughsatisfyingtherequirements ofthis
D.Iraotive,constitutesahazardtohealthorsafety,itmayprovision­
allyprohibitthesaleofthatsubstanceorsubjectittospecial
oonditionsrulinginitsterritory.Itmaysimilarlytakesuoh
iroas'.iroswhereitisobviousthattheinformationnotifiedaocording
toArticle6isfdlseivfilco.
ItshallimmediatelyinformtheCommissionandtheotherMemberStates
thereofandgivereasonsforitsdecision.
2.TheCommissionshall,withinsixweeks,consultwiththeMemberStates
conoemod,expressitsOpinionwithoutdelayandtaketheappropriate
stops.
3.llheretheCommissionisoftheopinionthattechnicaladaptationstothis
Directivearenecessary,suohadaptationsshallbeadoptedbyeitherthe
CommissionortheCounciltindertheprocedurelaiddowninArtiole19*
Inthisevent,theMemberStatehavingadoptedsafeguardmeasuresmay
mairrtaintherauntilsuohadaptationsenterintoforce.
Article22
MemberStatesshallinformtheCommissionofalllaws,regulationsand
administrative provisionswhiohtheyadoptinthefieldcoveredbythis
Diroctive."

-17-
/
AnnexesVI,VIIandVIII,whichappearmtheannextothisdirective,
areaddedtothedirectivementionedinthefirstparagraphofthis
artiole.
Article2'
llenberStatesshalladoptthemeasuresneededinordertocomply
withthisDirectiveandshallapplythen"by1stJanuary1979at
thelatest.TheywillinformtheCommissionandtheotherMember
Statesimmediatelyofsuchmeasures.
Article3..'.
ThisDireotiveisaddressedtotheMemberStates.

1
.A2WEX VI
Parameters forevaluating the environmental risk of
cerfrain substances
The environmental risk ofasubstance isevaluated ,onthe "basis ofthe
following primary ooncepts andtheir possible correlation .
A. Quantities
B. Potential toxicity forvarious targets
C. Exposure ofvarious targets
Asregards these concepts thefollowing parameters should particularly
"betaken into account :
Tonnages forecast "bythemanufacturer ,expressed intonnes /year
A.2 Production broken down according totype ofutilization andexpressed
asapercentage ofthetotal production .
ι
B.1 Acute toxicity tomandetermined byexperiments onrnamnals depending
ontheintended useofthesubstance .They maybeadministered in
these tests orally ,percutaneously orbyinhalation ,'
B.2 Chronic andmiscellaneous toxicity
Thefollowing parameters should betaken into consideration as
appropriate :
-sub-chronic toxioity (repeated daily doses onrats for90<3^ys)»
-chronic toxicity (studies onrats (1year )andpossibly ondogs
(3years )),
-carcinogenesis
-mutagenesis over three generations ,
-teratoganesis

~2~
B.3 To:d.o effects onother living creatures
Depending ontheanticipated uses ofthesubstance andonthepoter >-
tial receiving media ,ananalysis should "benade ofthetoxicologioal
effects onother forms oflife such asbaoteria ,algae ,fish and "birds ,
C.1 Anticipated uses
ι
'•Initial 'media :the specific purpose ofthesubstance should "bo
considered with aview toidentifying primary targets liable to
exposure ;
-type ofdistribution :this involves anassessment ofdispersal
risks .Asaguide ,thefollowing distinctions might beborne in
mind :
.substances whose use isconfined toolosed systems ;
.substances used only byapproved users orspecialists ;substances
whose use isconfined toalimited number ofindustrial estaT >-
lishments ;
•substances used only byprofessional specialists worl:ing inin­
dustry ,oraft trades andagriculture ;
•substances retailed tothegeneral publio .
C.2 Dispersal :Inthis case thotransport ofasubstanoe from its
initial medium should beassessed asfaraspossible with theaimof
identifying thereceiving media# Aocount should betaken oftho
physioal ohemical andbiochemical properties ofthesubstance .
•Αν

-3-
C.3 Stability m -thepresenoe ofnatural agents
This involves Assessing thestability ofasubstance under abiotic
and biotic conditions invarious environments .
Thephysico-chemical properties ofthesubstance should betakon
into account ,forexample ,stability asafunction ofpH,thermo­
stability ,redoc potential ,andthepossibilities ofbiodo gradation
inthereceiving medium .Where studies have been carried out tfm
models ,consideration should begivon tothehalf-life figures ;whore
this isnotpossible ,arough assessment ofthis period should bemade
onthe basis ofthe data available .
C.4 Accumulation within receiving media andthecreatures living therein
Thoaimhere istoassess asfaraspossible whether the substance
islikely tobuild upinagiven target inthereceivingjjaedium .
This mayeither take thoform ofge©accumulation orbi©accumulation .
IJhcre studios (e.g. ,accumulation infish )have been carried outon
modols ,consideration should begiven torelative preferential accu­
mulation figures ;when this cannot bedone ,thepossible extent of
anyaccumulation phenomena should beconsidered inthelight ofthe
relevant physico-ohemical properties ,e.g. ,thopartition coefficients
ofH20/organio solvents .
C.5 Possibilities ofdisposal
Atissue here iswhether thesubstance ,onoe ithasbecome waste ma­
terial ,canbedisposed ofbysuitable treatment bearing inmind .the
behaviour ofthesubstanoe ina'purification orincineration plant .

AflNEXVII
IHFOHMATION REQUIREDFORTHETECHNICALDOSSIER
REFERREDTOINARTICLE6OFTHISDIRECTIVE
Thi'Annexisin-tendedasaguide.Consequently ,someoftheinformation
requestedmayattimehesuperfluousoralternatively requireamplification .
Ί.':'·'Γί
Theobligatoryinformation whichthemanufacturer mustprovideismarked
byanasterisk;ifitisnotpossibletogiveananswer,thereasonsmust
bestated.
*I.ID5NTITY QFTHESUBSTANCE ..•.
*I«l«Chemicalname
*I.l.l.NameintheIUPACnomenclature
*1.1.2.Othernames -.,.....
*1.2.Empiricalandstructuralformula
*I*3»Composition ofthechemicalproduct
*I.3«l«Degreeofpurity($)'
*1.3*2.Natureofimpurities,includingisomers.-andbqooMaryjproducts
*I*3*3*Percentageofmainimpurities
*I.4«Methodsofdetectionanddetermination
Afulldescrpitionofthemethodsusedortheappropriate
bibliographical referenoes^

*2*DATAONUTILIZATION
v
*2.1.Proposeduses
*2.1.1.Typeofuse
Describe:–thefunctionofthesubstance
-thedesiredeffects•*•.•••••.iiiiiii
*2.1.2.Typeofdistribution
Indicatedestination ofsubstance :
–Closedsystem...................................... /V
–Processingindustries /
-Farmersandskilledtrådes...••••••••••«fl
–Thesubstanceisretailedtothepublic
*2.2.Estimatedproductionand/orimportsforeachoftheanticipateduses
orfieldsofapplication
*2.2.1.Overallproductionand/orimports:
–First12months *t/year
–Thereafter.....................t/year
*2.2.2.Breakdownofproductionand/orimportsaccordingtopoints2.1.1.
and2.1.2,expressedasapercentage
–First12months...ll^.l..*!*.......\«'<*;:VA.?.
–Thereafter -
*2.3*Recommended methodsandprecautions concerning :
*2.3*1*Handling
*2.3*2.Storage
*2.3*3*Transport *1.....1..1.
*2.3*4*Fire
*2.4*Emergenoymeasuresincaseofaccidentalspillage

3
3.PHYSIC0–CJHHJ-1ICALSPROPERTIES OF1THESUBSTANCE
(statewhetherthisisthepureorthecommercialsubstanceandgive
thereferenceoftheinternationally recognized ,methodsora..
desoriptionofthemethodsused).
*3.1.Meltingpoint
t«»iiiii>
°C
*3*2.Boilingpoint
°Cat........Pa
*3»3»Relativedensity
o>420)
*3.4.Vapourpressure
Paat °C
•»•i«i»♦i__ ...,..........Paat °C
*3»5»Surfaoetension
N/m(,.°C)
*3.6.Water-solubility
1.mg/l.(••••.•••.°C)
*3«7*Pat-solubility
Solvents^/fishoil-cornoilf
mg/l00gr.solvent(#^..°C)
*3*8.Partitioncoefficient
Water/non-misciblesolvent(pleasespecify):
Water/lipid(pleasespecify);
*3*9*Plashpoint
°C[Jopen-airsituationf~~}enclosedsituation
*3«10.Explodability (withinthemeaningofDirective67/548/EEC)
'•3.11.Redoxpotential
3.12.StabilityrelatedpH
3.13*Otherproperties(e.g.chelatingtendancy)

4JTOXICOLOGZCAL .STUDIES
(state whether thetests were carried outwith thepure orthecommercial
s-abst.au ses)
4.1 .Acute toxicity
4.1.1 .Absorbed ,orally
U)(rat)..... !••••. .....(mg/kg)
Symptoms observed intheorgans affected ; • ••
(including allergic reactions )
4.1.2 .Absorbed through theskin
LD–(rat)..................... (mg/kg)
Symptoms observed intheorgans affected
(including allergic reactions ).........
4»I«3 .Absorbed byinhalation
/ * I.ltlll ««!.. / ,* *.♦.iti»II t
LC50(rat) (ppri)(... h)
Symptoms observed intheorgans affected *^ -_0 – –
(inoluding allergic reactions ).......
4.1.4 .Irritant /corrosive effects
(Within themeaning ofthis directive ,Annex VIII Points 2&3),
4*2 .Delayed toxicity
4.2.1 .Subacute toxicity (90days )
Symptoms observed according totheconcentrations used :
4.2.2 .Chronio toxicity (substance anditsmetaholites )
Symptoms observed during tests lasting more than 90dayss
4*2.2.1 Substances retailed tothepublic asforseen onpoint 2.1.2 /thdash .
4.2.2.2 Other substances

5
4.3 .Other_ef feet s
4.3.1 .Mutagenic effects
*4.3.1.1 Screening -test *
. .. -
4*3"»1«2 "Whole study '
4;3.2 Carcinogenic effects
4.3.3 Effects onreproduction ,including teratogenicity
4.4# Special studies specific tothesubstance
Forexample :"biochemical kinetic studies ,neurophysiologies !toxicity
studies
*;5.ECOTO xIÇOLOG IÇAL_STL'D IES'
(State whether thetests were carried outwith thepure orthe
commercial substance ).
5*1 *Effects ontypical species
* Effects onfish :atleast twospecies including rainbow trout
LC^Q.......... mg/l;durâtionoftest : h
5.1.2 .Specific effects ofthesubstance onother typical species in
relation with itsdispersion intheenvironment .
Forexample :birds tbacteria
*6.BIOTIC ANDABIOTIC PEGRADABILITY ANDEERSISTAMCE
Evaluate the half-life ofthe substance :
a
a
un
n
π
Specify thedata onwhich this evaluation isbased (stability toheat
photoohemioal stability ,biodegradability etc).T1 1year
2
3months <L.T1 1year
2
1month <1 T1 3months
2
I'week ^ T1 1month
2
T1 <*" 1woek

6
*7.POSSIBILITIES OFRENDERING THESUBSTANCE HARMLESS
*7»1«Forindustry /craft trades
* Recovery possibilities :
*'1.1.2 ,Neutralizatiori possibilities :
*1,1,3 *Destruction poasibilities :
–Controlled discharga
–Incineration
–Water purification station
-Others
*7.2 .For thopublic atlarge
*1,2 ,1.Recovery possibilities :
*1.2.2 .Destruotion possibilities :
–Controlled discharge
–Incineration
-Water purification station
-Others
8.SPECIAL STUDIES
8.1.Degradation products andmetabolites
8.2.Biotio accumulation
8.3.Abiotio accumulation

AHHEXVIII
DET3PJ.IDTATI01T OPCLASSIFICATION ESTTH3CATEGORIES,TOXIC,KARIJFJL,
CORROSIVEANDIRRITAFT
(SeeArt.3>para3)
1.Substancesandpreparations shall "beclassifiedbyestablishing the
actualacutetoxicityofthecommercialproduct,expressedinLD^Q
values,determinedinanimals.ForthispurposethefollowingLC^Q
valuesshallbetakenasreferencevalues:
Absorbedorally:(LD^^oralinrat)
upto25mg/kgbodyweight:•"highly1020.0",
over25mg/kgbutnabmorethan200mg/kgbodyweight:"Toxic"
over200mg/kgbutnotmorethan2,000iag/kgbodyweight:"harmful".
Absorbedthroughtheskin:(LD^^cutaneousinratoriabbit)
upto50mg/kgbody.weight:"highlytoxic",
over50mg/kgbutnotmorethan400mg/kgbodyweight:"toxic"
over400mg/kgbutnotmorethan2,000mg/kgbodyweight:"harmful".
Absorbedbyinhalation(LC^Qinhalationinrat)
Forgaseousandvolatileproductsorproductswhiohcontain
volatilecomponents :
upto0.5ng/lair:"highlytoxic"
over0.5mg/lairbutnotmorethan2mg/lair:"toxic",
over2mg/lairbutnotmorethan20mg/lair:"harmful".
Formixturesofcomponentswithvaryingvapourpressures,forpreparations
asarenotunequivocally gasedusandforfumigantsandaerosols,itmust
becheckedwhether'thecommercialpreparationcontainsvolatilecomponents
w&ichcouldbereleasedintotheenvironmentinaotivelytoxioquantities:

Iftheratdoesnotdiewithin14daysofbeingexposedfor1hourto
c;+nratecla-'r-vapovirmixture(notacuterespiratorytoxicity),the
classificationshall"bealignedontheLD^Qvaluesfound.Shoulddeath
occur,theLC^Qvaluewillhaveto"beascertained.
Substancesandpreparations shall "beclassifiedas:
"corrosive"if,intestsonrabbits,thecommercialproductdestroys
thetissue(necrosis)within30minutesof"beinginuninterrupted
contactwiththeskinforaperiod6£7daysinaquantityof0.5ail
or0.5gf
Substancesandpreparations shallbeclassifiedas:
"irritant"if,intestsonrabbits,theycauseinflammation within30
minutesofbeinginuninterrupted contactwiththeskinforaperiod
of3daysinaquantityof0.5mlor0.5g.
Ifthereareindicationsoftheexistenceoftoxiceffects,apartfrom
acuteeffects(e.g.carcinogeniceffects,etc.),substancesandprepara­
tionsmayalsobeclassifiedashighlytoxic,toxicorharmfuldepending
ontheimportanceoftheseeffects.