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DOCUMENTS "COM"
COM(81)573
Vol.1981/0175

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COMMISSION OFTHEEUROPEAN COMMUNITIE
COM(81)573 final
Brussels /19October 1981
Proposal for a
COUNCIL DIRECTIVE
amending fortheseventh -time Directive 76/769/EEC onthe
approximation ofthelaws,regulations andadministrative
provisions oftheMember States relating torestrictions
•v\onthemarketing anduseofcertain dangerous substance
.^andpreparations
*
(submitted tothe Council bythe Commission )
COM (81)573 final

-1- Cc^£r5
EXPLANATORY "MEMORANDUM
GEMERAL • '
1.ThisproposalforadirectiveprovidesforadditionstotheAnnexto
Directive76/769/EEC^relatingtorestrictionsonthemarketinganduse
ofcertaindangeroussubstancesandpreparations .Currentscientific
knowledge,indicatesthattheuseoffivechemicalsubstancesshould
beprohibitedinthemanufacture ofspecificproducts,sincethese
/substanoescanberegardedas,ahealthrisk.
2.Thetwoproductsinquestionarefire-retardant andtheiruseisprohibited
intextilesintheFederalRepublicofGe,rmanyaThefirstTEPA,givesa
positivereactioninseveralmutagenesistestsandrevealsasub­
stantialdegreeofcutaneousabsorption,thesecond,thePBBs,are.
persistentandsimilarinbehaviourtothePCBswhicharealreadylargely
prohibited.
3.Thepresenceof3»3'–dimethoxybenzidine hasbeendemonstrated in.
sneezingpowder.ThisproducthasbeenprohibitedinFranceandCanada
foruseinthemanufacture ofsneezingpowderbecauseofits
structuralsimilaritywithbenzidine,aknowncarcinogen,-eventhough
A
itsmutagenicandcarcinogenic propertiescouldnotbeformally
established.Children,whoarethemainusersofthesenoveltyandjoke
products,andwho,moreover,aremoresensitiveasagroupthanadults
totoxicsubstancesshouldnotbeexposedtothisrisk.
4.Ammoniumpolysulphides areusedinstinkbombs.Theyreleasenoxious
vapourswhichhaveacorrosiveeffect.Theymaycauseseriousinjury,
particularly totheeyes.Relativelyslightquantities maycause
inflamation oftheskinortheeyes.TheUnitedKingdomhasalready
prohibitedthemarketingofre-usablestinkbombs.
1OJNoL262,27.9.1976,p.201v.

5.Ithasalsoprohibitedtear-gascapsulescontainingmethyrbromoacetate ,
whicharesoldasnoveltyorjoketoys,sincetheycanhaveaharmful
effectontherespiratory systemandtheeyes.
6.TheScientificAdvisoryCommitteeontheToxicityandEcotoxioity
ofChemicalCompounds(CSTE)wasclearlyinfavouroftherestrictions
setoutintheproposalforadirectivewhenconsulted "bytheCommission.
7.Inadditiontotheprotectionofhumanlifeandhealth,thisproposal
foradirectiveisalsoconcernedwiththeefficientoperationofthe
CommonMarket.Sincetheadoptionofdifferentunilateral measures
limitingtheuseofcertainchemicalsmaycreatedistortions inthe
Communitymarketanddirectly'affectitsoperation,aCommunity
solutionshould "befoundinvolvingtheapproximation oftherelevant
nationallegislation inthisfield.
Lastly,theproposalforadirectiveseekstoinducemanufacturers to
replacethedangeroussubstancesusedintheirproducts "bychemicals
posinglessofahealthrisk.
COMMENTS ONTHEARTICLES
Article1
ThisArticleprovidesfortheadditionoffivechemicalproductstothe
AnnextoDirective76/?69/EEC•Useoftheseproductsisrestrictedbecause
ofthehealthriskwhichtheyrepresent.
Article2and3
TheseArticlesappearinalldirectives.

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III.PREPARATION OFTHEDRAFTDIRECTIVE
Theproposalforadirectivewasdrawnupinresponsetonotification
fromtwoMemberStatesafterconsultation ofworkingparty
consistingofexpertsinthefieldsofpubliohealth,hygiene,
industrialsafety,industryandcommerceandconsultation withthe
CSTEandtheindustrialand"professional organisations poncerned.
TV.CONSULTATION OFTHEEUROPEAN PARLIAMENT ANDTHEECONOMIC ANDJw$ 1
SOCIALCOMMITTjgj;
Sinceimplementation ofprovisionssetoutintheproposalfora
directivewouldentailamendmentstoexistinglegislation inthe
MemberStates,|heopinionofthesetwobodiesisindispensible and
•%
shouldbeobtainedinaccordancewiththesecondparagraphofArticle100
oftheEECTreaty.

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PROPOSAL FOR ACOUNCIL DIRECTIVE
amending fortheseventh time Directive 76/769/EECon
theapproximation ofthe laws ,regulations and .administrative
provisions oftheMember States relating torestrictions
and use
onthemarketing /ofcertain dangerous substances and
preparations
THE COUNCIL OPTHEEUROPEAN COMMUNITIES ,
Having regard totheTreaty establishing theEuropean Economic Community ,
and inparticular Article 100thereof ,
Having regard totheproposal from theCommission ,
Having regard tothe opinion oftheEuropean Parliament ,
opinion ofthe
Having regard tothe/Economic andSocial Committee ,
Whereas theuseoftri-(2,3-d.ibromopropyl )-phosphate tofireproof
textile articles wasprohibited byCouncil Directive 79/663/eEC^"
because ofthehealth risks itinvolves andwhereas subsequent exami­
nations have shown that two other fire-retardant products ,
tris-(aziridinyl )-phosphinoxide (TEPA )andpolybrominated biphenyls (PBB),
are harmful tohealth and ,consequently ,should notbeemployed in
text iLeart icleswhichcome into contact with theskin ;
Whereas 3,3'dimethoxybenzidine isused inthemanufacture ofsneezing
thoughpowder andwhereas ,even /the information concerning themutagenic
andcarcinogenic properties ofthis substance isnot conclusive ,the
affinity ofthis substance tobenzidine ,which hasadefinitely
established carcinogenic effect onman ,suggests that great caution should
beexercised inrespect ofitspotential risks tohuman health ;whereas
itisclear that sneezing powder ismainly used bychildren who ,in
principle ,represent agroup which issensitive totoxic chemicals and
who should ,consequently ,receive special protection against health
hazards ;whereas ,therefore ,theuseofthis substance should be
prohibited insneezing powder ;
10JNoL197,3.8.1979 ,P.37

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Whereasairimoniumpolysulphides haveacorrosiveeffectandmaycause .
serious,lastingdamage,particularlytotheeyes;whereasthese
compounds,whicharesoldinparticulartochildrenasnoveltiesorjokes
incontainersthatcanbere–used,areespeciallydangerousandwhereas
theiruseshould,consequently ,berestricted ;
Whereasmethylbromoacetate isusedasteargas;whereasithasanirritant
effectupon "therespiratory systemandtheeyes;whereas,in
strongconcentrations ,itproducesacorrosiveeffectandcancauseirre­
versibledamagetotheeyes;whereasitshouldnotbeusedbychildren
anditsemplcynmtasanoveltyorjokeshould,therefore,be
prohibited ; ,
Whereastherestrictions alreadyintroducedbysomeMemberStatesindirectlyrespectoftheabovementioned substances/affecttheestablishment -or
^functioning oftheCommonMarketandwhereasitisthereforenecessary
toharmonizeexistinglegislation inthisfieldintheMemberStatesand
1toamendaccordinglytheAnnextoCouncilDirective76/769/EEC>
HASADOPTEDTHISDIRECTIVE
Article1
ThefollowingitemsareaddedtotheAnnextoDirective76/769/EEC:
"8.Tris-(aziridinyl)-phosphinoxide (TEPA))maynotbeusedintextile
)articlesintendedtocomeinto
9.Polybrominated biphenyls(PBB)^)contactwiththeskin
10.3,3'-dimethoxybenzidine maynotbeusedin
CASNo119-90-4 *sneezingpowder
11#Ammoniumpolysulphide may.notbeusedincontainers
whichmaybeemployedseveral
timesasnoveltiesorjokes
12.Methylbromoacetate maynotbeusedinnovel–
CASNo96-32–2 ties,jokesorhoaxes"
10JNoL262,27.9.1976,p.201

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Article2
MemberStatesshallbringintoforcetheprovisionsnecessaryto
complywiththisDirectivebefore1July1982.Th^yshallforthwith
informtheCommissionthereof.
Article3
ThisDirectiveisaddressedtotheMemberStates.