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DOCUMENTS "COM"
COM(76)556
Vol.1976/0171

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(76)556 final
Brussels,16thNovember1976
Proposalfora
COUNCILDIRECTIVE
(-:L
ontheapproximation ofMemberStates'laws,
^•regulations andadministrative provisionson
-theprotectionofthehealthofworkersoccu­pationally
"•Rationally exposedtovinylchloridemonomer
(submittedtotheCouncilbytheCommission )
C0MC76)556final

MEMORANDUM
onthedraftproposalforaCouncilDirectiveonthe
approximation ofMemberStates'laws,regulations and
administrative provisions ontheprotectionofthe
healthofworkersoccupationally exposedtovinyl
chloridemonomer.
Chioroethyleneorvinylchloridemonomer(VCM)isa
gaseousproductandhasbeenknownforalmost150years.
Itspolymer(PVC),whichhasbeenmanufactured ona
commercialscaleforover40years,formstogetherwith
polyethylene amajorsectorofthechemicalindustry.
In197529chemicalcompaniesinthecountriesofthe
EuropeanCommunityproduced5milliontonnesofvinylchloride
(YCM)in26differentfactoriesand4.5milliontonnesofthe
polymer(PVC)in35factories.Ofthepersonsemployedinthese
chemicalplantssome10000areexposedtovinylchloride
monomer.
Processingintosemi-fabricatedandfinishedproducts
isdoneinsome5700plantsbyapproximately 350000workers
whoin1973producedgoodsworth4520millionu.a.
Sincethecommercialproductionofvinylchloride(VCM)
commencedaround1930,wehaveknownthatgaseousvinylchloride
hasanarcoticeffect.However,onlyveryfewcasesofacut#
intoxication havebeenrecorded.
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-II -
Upto1966 itschronic toxicity wasthought tobelow ,
but since then anincreasing number ofpublications have
appeared with reports ofhealth impairment caused byVCM ex­
posure .The first reports were ofanarcotic syndrome manifested
byasthenic andneurotic symptoms .These were accompanied by
digestive and liver troubles orneurovascular and skin diseases .
In1967 cases were reported ofacro-osteolysis inconnection
with Raynaud 'ssyndrome .
This was followed byamarked increase inanimal ex­
periments and industrial hygiene monitoring onaninternational
scale .The malignant tumours found inboth humans and animals ,
particularly liver tumours ,brought worldwide reaction .
Both national parliaments and theEuropean Parliament ,
aswell asemployer and worker organizations held discussions
onthe problems .The World Health Organizaion dealt with the
risk ofcancer presented byVCM atameeting ofthe International
Agency forResearch ofCancer held inLyon on23-25 June 1974 .
The same problem was also debated byinternational experts at
theconference oncancer held inFlorence inOctober 197^.At
the same time MEDICHEM added the carcinogenicity and genetic
effects ofthis substance tothe agenda ofits seminar inMilan .
Research contracts were awarded bythe Ministries ofLabour and
Social Affairs inthe countries concerned with the aim ofde­
fining the extent ofthe hazard and adopting more stringent
safety measures .
Various meetings and one seminar were organized bythe
departments oftheCommission during 197 ^-and .1975 .
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Duringthisseminaratthesemeetings,thefollowing
areasweredefinedandcorrespond tothedifferenthealth
aspects:
A.Workplace1)Productionofthebase
product:VCM
Production ofitspolymer:PVC
2)Transformation ofthepolymeri
sationproducts
B.Environmental protection
C.Consumerprotection +
D.Wastedisposal
Theconclusionsofthesemeetingsand.ofotherworkcarriedout
inparallelhaveledtheCommissiontoproposeadirectivewhichthe
Councilhasadoptedonthe27thJuly1976withregardtotheharmonization
ofthelegislationinMemberStatesrelativetothelimitationofthe
marketinganduseofcertaindangeroussubstancesandpreprations.(+)
ThisdirectiverepresentsthefirstCommunitymeasureaimedat
theprohibitionoftheuseofvinylchloridemonomer(VCM)asanaerosol
propellentforanypurpose.
ThisDirectivealsoanswerstherequestsmadebythe
EuropeanParliamentintheformoftwowrittenquestions.
Itistheresultofextensivediscussionswithindependent
expertsandoftwomeetingswithgovernmentexperts(19No­
vember1975and8-8December1975).Itsaimistodefine
preventivemeasuresintermsofbothtechnologyandIndustrial
hygienewhicharegearedtohealthprotectionatwork.
Directive76/769/EEC,OJL262of27.9*1976.„._,aQ.Mç.
■H-EuropeanParliament:writtenquestionsNos178/75and68l/75
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The Council ofthe European Communities ,
-Having regard totheTreaty establishing theEuropean Economic
CorMiuwity ,and inparticular Article 100 ,
-Having regard tothe Proposal from the Commission ,
-Having regard tothe Opinion oftheEuropean Parliament ,
-Having regard tothe Opinion oftheEconomic and Social Committee
Whereas inthepast VCMhasbeen recognized only asthecause ofthegenerally
reversible syndrome known as'occupational acro-osteolysis *;
whereas more recent evidence from epidemiological studies and
animal experimentation indicates that prolonged and/orrepeated
exposure tohigh concentrations ofVCM inthe atmosphere may cause
a'VCM' syndrome encompassing ,inaddition tooccupational acro-
osteolysis ,skin diseases such asscleroderma ,and liver disorders ;
Whereas VCM should also beregarded asacarcinogen which may cause
angiosarcoma ,arare malignant tumour which canaLso occur
without any known cause ;
Whereas although present-day working conditions are considerably
better than those under which theabove syndrome formerly occurred ,
acomparison ofprotective measures taken byeach Member
State reveals certain differences andtherefore ,inthe interests
ofdeveloping aneconomic and social balance ,these national
laws ,which have adirect effect onthe functioning ofthe com­
mon market ,should beharmonized and improved ;
Whereas the first action should betotake preventive and
protective measures based onthe latest scientific knowledge ,
sothat the internal concentrations ofVCM intheatmosphere inboth
existing andfuture factories canbereduced tominimal values ;
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s
-2-
Whereas medical surveillance ofworkers intheVCM/PVC industry
should becarried out onthe basis ofthe latest medical know­
ledge inorder that the health ofworkers inthis important
economic sector ofthe chemical industry may beprotected ;
Whereas the urgency ofthe harmonization oflaws inthis field
isrecognized byboth sides ofindustry ,both ofwhich took
part inthediscussion onthis specific -problem ;whereas efforts
must therefore bemade towards theupward harmonization oft-ews ,regulations
andadministrative provisions asenvisaged inArticle 117
ofthe Treaty ;
Whereas itmight prove necessary torevise the health protection
standards contained inthis Directive ;
Whereas ,tomake iteasier toadopt thenecessary measures ,
there should beaprocedure toensure close cooperation between
the Member States and the Commission within aCommittee to
amend this Directive inthe light oftechnical progress ,
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τ
-5-
HAS ADOPTED THIS DIRECTIVE :
Article 1
1.1 .The object ofthis Directive isthe protection ofworkers
employed inworks inwhich
-vinyl chloride monomer ,hereinafter referred toasVCM ,
isproduced ,reclaimed ,stored ,discharged into containers ,
|transported orused insome other way,
-vinyl chloride monomer isconverted into unformed vinyl
chloride polymers ,hereinafter referred toasPVC ,
who areexposed totheeffects ofVCM intheir working
area .
1.2 .This protection shall beensured bythe establishment of:
-limit values for the atmospheric concentration ofVCM
inthe working area ;
-measuring and monitoring techniques necessary for this
purpose ,aswell asother preventive measures ;
-guidelines for medical surveillance .
Article 2
For the purposes ofthis Directive :
2.1..The 'working area 1means asection ofaworks with defined
boundaries which may comprise one ormore workplaces .It
ischaracterized bythe fact that the individual worker
spends irregular periods oftime within itatvarious
workplaces inthe course ofhis duty orduties ,that the length
oftime spent atthese individual workplaces cannot be
|more closely defined ,andthat further subdivision ofthe
working area into smaller units cannot bemade .Itisassumed
that the individual worker isnormally employed inone
working area only .
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-il-
2.2 .The technical long-term limit value 1means themean con­
centration ofVCM ,measured over 1year ,inthe atmosphere
ofaworking area which may not beexceeded during exposure
toitfor 8hours adayor40hours aweek .
For practical purposes ,limit values for shorter reference
periods (i.e. 1month ,week ,shift orhour ),corresponding tjothe
technical long-term limit value ,are given inAnnex I.
Article 3
3.1 .The fundamental aim oftechnical monitoring shall beto
reduce tobelow measurable levels the atmospheric concentrations of
VCM towhich workers areexposed .Allworking areas inworks .referred
toinArticle 1.1 .shall therefore bemonitored forthepresence ofVCM .
3.2 .FornewVCM/PVCworks ,amaximum atmospheric concentration
of5ppm ,which may not beexceeded ,shall belaid down
asthe technical long-term limit value forVCM .
3.3 .Forexisting VCM/PVCworks ,amaximum atmospheric concen­
tration of10ppm ,which may not beexceeded ,shall belaid
down asthe teclinical long-term limit value forVCM .
3.4•Thenecessary -technical measures with respect tothelimiting technical
values given under 3.2 .and3.3 .shall notinanycase result inVCM
pollution ofthe environment outside theworks .
Article 4
The atmospheric concentration ofVCM intheworking area may
bemonitored bycontinuous and/ordiscontinuous methods .
4.1 .The technical long-term limit values shall beconsidered
tobecomplied with iftheannual arithmetic mean concen­
tration isfound not toexceed this value ,with aconfidence
coefficient of95# (one-sided test ).
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-5-
4.2 .Any measuring system giving areliable analysis atone-
third atleast ofthe technical long-term limit value
concentration shall beregarded assuitable .
4.3 *Ifnon-selective systems areused formeasuring VCM ,the
total measurement recorded shall betaken asthe VCM
concentration value .
4.4 .Measuring instruments must becalibrated adequately at
regular intervals .
4.5 *Pending theapproval atCommunity level of astandard
method for checking VCM measuring techniques ,suitable
methods based onthe latest state ofthe art shall be
ijused forcalibrating themeasuring instruments .
Article 5
One ormore measuring points may beset upinaworking area ,
depending onits size .
5.1 .Measuring points mu^bechosen inaccordance with the particular
characteristics ofthe works and sodesigned that the
results indicate asaccurately aspossible the individual
•VCM level ofexposed persons .
This does not necessarily mean that measurements must always
betaken with devices worn byexposed persons .Fixed position
instruments may also beused provided that the results ob­
tained thereby 5arerepresentative oftheconcentration throughout
the working area .
5.2 .Ifanumber offixed position measuring points are provided
inone working area ,the mean ofthe values from all the
points may beregarded asthemeasurement for thewhole
workino area .
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-6-
5.3 .Inall cases ofdoubt astowhether theresults obtained by
fixed position measuring instruments are represent .ve
ofthe concentration intheworking area ,themeasuring
point for the technical long-term limit value inthe
working area shall bethat point where the risk isgreatest .
Personal dosimeters maybe used for comparative measurements
where appropriate ,thearrangement ofthemeasuring points maybe
modified .
Article 6
Amonitoring system which gives continuous mean values for at
least one hour shall beprovided todetect abnormal increases
inconcentration levels caused bytechnical failures inwor­
king areas inworks producing VCM/PVC .
6.1 .The threshold .concentration atwhich the alarm istriggered
shall depend onthemeasuring system and onoperating con­
ditions .
6.2 .Anincrease inVCM concentration shall beregarded asabnor­
malwhen itexceeds approximately five times the mean
weekly value .Insuch anevent ,technical __
measures todiscover the causes shall betaken without
delay .
6.3 .Thealarm threshold shall not ,however ,begreater than
40ppm .Ifthis value isexceeded ,technical andpersonal
Sprotective ,measures shall betaken without delay .
Article 7
Appropriate personal protection shall beprovided forcertain
operations (e.g. cleaning ofautoclaves ,servicing andrepairs ),
during which itcannot beguaranteed that concentrations will bekept
below thepermitted limit values bymeans ofoperational orventilation
measures .
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*/5
-7-
Article 8
Workers shall beinformed atregular intervals ofthe health
hazards involved andoftheappropriate protective measures tobe
taken when handling VCM .
Article 9
Aregister shall bekept ofworkers employed onoperations de­
scribed inArticle 1.1.' ,with particulars ofthe type and duration
ofwork ,and theresulting exposure .Acopy ofthis register
shall begiven tothe industrial medical officer responsible
forsurveillance ,unless the register iskept bytheofficer
himself .
Article 10
Workers employed inworking areas referred to inArticle 1.1 .
shall undergo amedical examination byaqualified industrial
medical officer onrecruitment andalsosubsequently .
10.1 .Without prejudice tonational regulations ,the industrial
medical officer shall determine the frequency and the type
ofexamination tobecarried out ineach individual case .
The necessary guidelines are given inAnnex II.
10.2 .Medical records and the register provided for inArticle 9
shall bekept until thepossibility ofoccupational disease
caused byVCM exposure can beexcluded .
These records shall form the basis for further prognostic
epidemiological surveys which prove necessary ,the results
ofwhich shall bereported bythe Member States tothe
Commission atthree-yearly intervals .
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-δ­
ι
Article 11
11»1 »This Directive shall bereviewed atleast every twoyears
inthelight ofdevelopments intechnology andoccupational
medicine .
11.2.ACommittee consisting ofrepresentatives oftheMember
States ,with arepresentative oftheCommission as
Chairman ,shall besetupforthis purpose .
11.3.The Committee shall draw upitsown Rules ofProcedure . *
| Article12
12.1.Where theprocedure laid down inthepreceding Article , ^
istobefollowed ,the Chairman .shall refer the matter
tothe Committee ,either onhis own initiative orat
the request ofarepresentative ofaMember State .
12.2.The representative ofthe Commission shall submit to
the Committee adraft ofthe measures tobeadopted .
The Committee shall deliver its Opinion onsuch measures
within atime limit set bythe Chairman .according tothe
urgency ofthematter .Forty-one votes shall berequired
toconstitute amajority ,the votes oftheMember States
being weighted inaccordance with Article148(2)ofthe
Treaty .The Chairman ,shall not vote .
12.3.TheCommission shall adopt themeasures where they are
inaccordance with the Opinion ofthe Committee .
12.4.Where they arenot inaccordance with theOpinion ofthe
Committee ,orifnoOpinion isdelivered ,theCommission
shall forthwith propose totheCouncil themeasures tobe
|adopted .TheCouncil shall actbyaqualified majority .
12.5.IftheCouncil hasnotacted within three months ofthedate
ofthe submission o<fthe proposal ,the Commission shall
adopt the proposed measures .

-9-
Article 13
13.1 .Member States shall bring into force the laws ,regulations
and administrative provisions needed inorder tocomply
}with this Directive within 18months ofitsnotification
and shall forthwith inform the Commission thereof .
13.2 .Member States shall communicate tothe Commission the
texts ofthe main provisions ofnational law which they
adopt inthe field covered bythis Directive .
Article 14
This Directive isaddressed tothe Member States .
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ANNEX I
-1-
Statistical basis for the technical long-term limit value
1.Owing todifferences indefinition the recommended values
for the permissible concentration ofhazardous substances
inthe air atthe workplace currently vary from country
tocountry .
This Directive istherefore concerned with anew ,statistically
defined reference value -the technical long-term limit value ,,
which should beregarded asamean annual value (Article 2.2.)*
2.The limit values for shorter reference periods are based on
data obtained byextensive measurement ofVCM concentrations
inthe PVC industry .These results coincide with data for
other harmful substances and for other sectors ofindustry .
This information can besummarized asfollows :
a)theconcentrations distribution ofharmful substances can
|berepresented lognormally .
b)thelogarithmic variance T)isdependent onthemean
time fortheindividual values T^and theassessment period T
during which theindividual values areobtained .
5.This relationship canbeexpressed bythe following equation :
«^cr,T>=/hog t?/D.
Given these conditions ,amean ratio ofthelimit values for
shorter reference periods tothelong-term limit value canbe
established :
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ANNEX I
-2-
Table 1
4.Limit values for shorter reference periods shall beregarded
asbeing within thepermitted limits ifatleast 95$ofthe
measurement values established over atotal period ofone
year arebelow the limit values given inTable 1.
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ANNEXII//
-1-
Guidelines formedicalsurveillance
.1
I
1.Currentknowledgeindicatesthatover-exposure toVCMcangive
risetothefollowingdisorders anddiseases :
-sclerodermatous skindisorders
-circulatorydisordersinthehandsandfeet(similar
toRaynaud'ssyndrome)
-acro-osteolysis (intheregionofvariousbonestructures
andaffectingparticularly thehandphalanges)
-liverandspleenfibroses(similartoperilobular
fibrosis,knownasBanti'ssyndrome)
-lungfunctiondisorders
-thrombocytopenia and
-hepaticangiosarcoma .
2.Medicalsurveillance shouldtakeaccountofallsymptomsand
syndromes,withparticular emphasisontheareaofgreatest
risk.Asfarasisknown,nosymptoms,occurringseparatelyor
incombination havebeenidentified asprecursors ortransition­
alstagesofhepaticsarcoma.Asnospecificmethodsofpreven­
tiveanalysisareknownforthisdisease,medicalactionmust
includeatleastthefollowingmeasuresasminimumrequirements :
l)recordsoftheworker'smedicalandoccupational history
•2)clinicalexamination oftheextremities ,theskinand
theabdomen
3)X-rayofthehandbones(everytwoyears).
Furthertests,particularly laboratorytests,aredesirable.
Theseshouldbedecidedbythemedicalofficerinthelightof
themostrecentdevelopments inindustrial medicine.
Thefollowinglaboratorytestsaresuggestedatpresentfor
prognostic epidemioxogical surveys:
-urinalysis (glucose,proteins,salts,bilepigments,
urobilinogen );
-erythrocyte sedimentation rate;
-bloodplateletcount
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-determination oftotalbilirubinlevel
-determination oftransaminase levels(SGOT,SGPT)
-thymolturbiditytest
-alkalinephosphatase level
-determination ofcryoglobulin .
3.Asinthecaseofallbiologicalexaminations ,theresults
ofthetestsmustbeinterpreted inthelightofthelabora­
torytechniquesusedandtheirnornialresults.Generally
speaking,thesignificance ofafunctionaldisorderis
revealedbyJointconsideration oftheresultsobtainedwith
thevariousmethodsandbydevelopments inthoanomalies
observed.Asageneralrule,abnormalresultsmustbofurther
investigated and,ifnecessary,additionalspecialist ;
examinations carriedoub.
4LTheindustrialmedicalofficershalldecideineachcase
whetheraworkerissuitableforaparticular workingarea.
Theindustrial medicalofficershallalsobecompetentto
decidewhatconera-Lnd.L<!ationsapply.
Themostimportantoftheseare:
-typica.lvascularananeurovascularlesiona,
-lungfunctiondisorders,
-clinicalorbiologicalhepaticInsufficiency ,
-diabetes,
-chronicrenalinsufficiency ,
-thrombocytopenia andhemorrhagic disorders,
-certainchronicskindiseasessuchas.scleroderma *
-abuseofalcoholand/oraddictiontodrug;>.
Thislist,whichIsIntendedmerelyforguidance,hasbeen
drawnupusingpathological dataobtainedfromprevious
retrospective studies.
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