ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(76)680
Vol.1976/0205

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(76)680final
Brussels,20December1976
Proposalfora
COUNCILDIRECTIVE
ontheapproximation ofthelawsofthe
MemberStatesrelatingtomaterials and
articlescontainingvinylchloridemonomer
andintendedtocomeintocontactwith
foodstuffs
(submittedtotheCouncilbytheCommission )
C0M(76)680final

*°iL~~
EXPLANATORY MEMORANDUM
I.General
V?,yichloridemonomer(VC)\acolourlessgaswhichisusedasabasic
sv..stancein"theproduction c..f;■olyvlnylchloride(PVC),atpresentoneof
theplasticsmostcommonlyused»ox-thpackagingoffoodproducts.Until
196O,VCwasregardedasaharmle-gas,'ithanarcoticeffect.Inthe
earlysixtiessomescientists demoi*tratt.thatVChadharmfuleffectson
healthandcausedacrosteolysis ,scltcoder..0.,andliverdiseases.In1970,itwasfirstsuspectedthatVCcould,when-haled,hersponsiblefor
oncogenouseffects.In1973and1974»thesi-v-iltaneousdJvcoveryof
tumoursofthesametype(angiosarcomainthe„.'ver)inrattexposedto
highdosesofVCandinmenwhohadworkedforiv-ngperiodsthePVC
industryconfirmedthevalidityoftheearlysuspicions.
WhileexperimentswerebeingcarriedoutoninhalationofVC,researchwas
startedin1974"todeterminetheeffectsonratsoftheadministration of
VGperos.Afteraboutayearofthisresearchthediscoveryoftumoursin
someratsimmediately promptedtheCommissiondepartments concernedtoquestiontheScientificCommitteeforFoodstuffs*,whichon27June1975had
deliveredanopinionwhichincludedthefollowingpassages"Theaimshould
thereforebetotakeallpossiblestepstcreduceallformsofexposuretoVC...ThelevelsofVCinPVCandrelatedpolymersshouldbereducedasfar
aspossible...VCshouldnotbedetectableinfoodorpotablewaterbyan
agreedmethod Atasubsequentmeetingheldon13-14November1975,
theScientificCommitteerecognizedthelimitsofsensitivityofthemethods
andsuggested,asatemporarymeasure,theadoptionof"amethodofanalysis
whichwouldbeapplicablegenerallytomostfoodsbymostcontrollaboratorieswithaunitofdetectionof0.050mg/kg".
InordertostudywaysofapplyingtheopinionoftheScientificCommittee
andofdefiningthemethodofanalysisforVC,theCommissionorganized
severalmeetingswithrepresentatives oftheMemberStates*Governments
andofthePVCindustry,andaskedfortheopinionoftheAdvisoryCommittee
onFoodstuffs ,inwhichthevariouseconomioandsocialgroupsare
represented .
Untilthevariousseriesofexperimentscurrentlyinhandinmanycountries
havebeencompletedandtheresultsoftheresearchallowanexact
assessmenttobemadeoftheriskinherentintheuseofVCinmaterials
andarticlesintendedtocomeintooontactwithfoodstuffs,theCommission
wishes,asaprecautionary step,topresenttheappendedproposalforadirective. " .
1OJNoL136of20May1974.
2OJNoL182of12August1975

-2-
II.Commentsontheproposalforthedirective
TheappendeddraftrepresentsadirectiveimplementingtheDirective76/.../EECof22November1976concerning
materialsandarticlesintendedtocomeintocontactwithfoodstuffs
(Article1).ItproposesfixinglimitsfortheVCcontentinmaterials
andarticlespreparedwithVCandinfoodstuffswhichcomeintocontact
withsuchmaterialsandarticles(Article2andAnnexi).
ThefixingoflimitsfortheVCcontentofmaterialsandarticlesaswell
asforthepresenceofVCinfoodstuffsisproposedwithaviewtoreducingtoaminimumtheprobabilityofVCmigrationintofoodstuffs,andthus
offeringanadditionalguaranteetotheconsumer.Furthermore,thefixingofsuchlimitsobligesindustrytomonitortheproductionofPVCmaterials
andarticlescontinuouslyandallowstheStatetointervene,ifnecessary,beforethemarketingofthematerialsandarticles,orthefoodstuffswith
whichsuchmaterialsandarticlesareincontact.MonitoringoftheVC
levelinfoodstuffs,althoughessential(accordingtotheopinionofthe
ScientificCommittee;"thereisnogoodcorrelationbetweenthefreevinylchloridemonomerconcentration inPVCendtherelatedpolymersandthe
amountofVCmigratingintofoodincontactwiththesepolymers"),doesnot
permitpreventivemonitoringofproductionanddoesnotreducethepresence
ofVCinfoodstuffstoanabsoluteminimum,sincethisminimumdependsonthe
sensitivityandaccuracy.oftheanalyticalmethods.Finally,thefixingofa
limitcnVCinmaterialsandarticlesisaneffectiveandsimpleway'ofreducing
toaminimumthearigrjfclonofVCfrommaterialsandarticles(e.g.tubes,plasticsheets,partsofapparatususedforfoodprocessing)incaseswherethe
fixingofaVClimitinthefoodstuffwouldbetotallyinadequatetoprotect
consumerhealth,sincesuchmaterialsandarticlesarenotmarketedtogetherwiththefoodbutareintendedtocomeintocontactonlyincidentally whenofficialgovernmentinspectioncannotbecarriedout.
Themaximumvalueof0.050mg/kgforVCinfoodstuffsistheminimumamount
whichcanatpresentbedeterminedwithsufficientaccuracyinthe
majorityoffoodstuffsbythemajorityoflaboratories.Thisvalueisalso
theonecurrentlyenvisagedinthelawsorproposedlawsalreadyexistinginthecountriesoftheEuropeanCommunity.ThemaximumvaluesforVCin
thevarioustypesofPVCmaterialsandarticles,however,representthe
minimumquanitieswhichcannowbeobtainedbyapplyingthemostadvanced
technologies.Withtheselimitsandonthebasisofcurrentlyavailablescientificdocumentation ,itishighlyprobablethatthemaximumquantityofVCpresentinfoodstuffsunderthemoststringentconditionsof
preservationiswellbelow0«050mg/kg.
Sincefurtherdevelopmentsinthemanufacturing techniquesusedforPVC
materialsandarticles,inthemethodsofdetermining VCinfoodstuffsand
intheassessmentofthehazardspresentedbyVCaretobeexpected,arapid
procedureforadaptingtheDirectivetotechnicalprogressisalsoprovidedfor(Article4).

-3-
Anxx6XXIsetsou*t"thomethodof*analysis "bobeus©dforverifyingVClevelsinfoodstuffsandPVCmaterialsorarticles.
m*ConsultationoftheEuropeanParliamentandth*EconomicandSocialCommittee ~~–––-
Thetextnowproposedwillconstitutea"specificDirective"
withinthemeaningofArticle3oftheDirective76/..../EECandthereforemustbeadoptedundertheprocedureprovidedforin
Article100oftheTreaty–ByvirtueofthesecondparagraphofthislatterArticle,consultationwiththeEuropeanParliament
andtheEconomicandSocialCommitteeisrequired.
Implementation oftheprovisionsoftheDirectivewillinvolve
amendmentstothelegalprovisionsinalltheMemberStates.

-4-
Proposal foraCounoil Direct iveontheapproximation ofthelaws ofthe
Member States relating tomaterials andarticles containing vinyl chloride
monomer arri intended tocome into oontaot with foodstuffs
C.3COUNCIL TOTHEEUROPEAN COMMUNITIES ,
nzing regard totheTreaty establishing theEuropean Economic Community ,
Having regard toDirective 76/.«../EECof22November 1976 ontheapproxi­
mation ofthe laws oftheMember States relating tomaterials andartioles
intended tocome into contact with foodstuffs ,erdinparticular Article 3thereof ,
Having regard totheproposal from theCommission ,
Having regard totheepinion oftheEuropean Parliament ,
Having regard totheopinion oftheEconomio andSocial Committee ,
Whereas Article 2of Directive 76/..../EECprovides that materials
andarticles must nottransfer tofoodstuffs at^yconstituents inquantities
liable toendanger publio health ;
Whereas Article 3ofthe same Directive provides that theCouncil under the
procedure provided forinArticle 100oftheTreaty shall adopt by
Directive special provisions applicable tocertain groups ofmaterials and
articles ('fepecific Direotives ");whereas these provisions mayinclude specific
limits onthemigration ofcertain constituents into oronto foodstuffs as
well asother rules toensure compliance with Article 2ofthesaid Direotive ;
Where astheadministration oflarge doses ofvinyl chloride monomer toexpe­
rimental animals hasbeen shown toproduce harmful effects andwhereas
such effeots could also occur inman ;
Whereas theScientific Committee forFoodstuffs hasgiven theopinion that
"thelevels ofvinyl chloride monomer inpolyvinyl chloride andrelated
polymers should bereduced asfaraspossible "and atthe same time recom­
mended that "notrace ofvinyl ohloride should bedeteotable infood orpotable
water byamethod which canbegenerally applied tothemajority offoodstuffs
bymost laboratories ";
■/.
(1)J.O. n°L

-2-
Whereas further research isatpresent inprogress onvinyl ohloride monomer ,
"butasaprecaution theabsorption ofvinyl chloride monomer should beres­
tricted until these results areknown ;
Whereas theadaptation oftheDirective totechnical progress isanimple­
menting measure andwhereas ,inorder tosimplify andaccelerate theprocedure ,
this should betheresponsibility oftheCommission ;
Whereas ,inallcases inwhich theCouncil oonfers ontheCommission autho­
rity toimplement rules relating tomaterials andarticles intended to
come into contact with foodstuffs ,aprocedure should belaid down esta­
blishing close cooperation between theMember States andtheCommission
within theStanding Committee onFoodstuffs setupunder theCouncil
Decision of13November 1969 »
HAS ADOPTED THIS DIRECTIVE s

Artiole1
pursuanttoArticle3oftheDirective76/.../EECof22November1976
this"Directiveconeernematerialsandarticlespreparedwithvinyl
c*voriacpolymersorcopolymers vfliichintheirfinishedstateare
xr,udsd+.ocomeintocontactwithfoodstuffs,orwhioharein
co-actw.'hfoodstuffsandareintendedforthatpurpose.Theyaxehereinafter' called"materialsandarticles".
Article2
Materials andarticlesshallnot
containvinylchlo.-.&emonomerinquantitiesexceedingthelimitslaid
downinAnnexI.
Foi.v*stuffshavingcomeintocontactwithmaterials
andarticlesshallnotcontain^iny!chloridemonomerinquantitiesexceedingthelimitlaiddowninAnnexI.
Artide3
CompliancewiththelimitslaiddowninAnnexIshallbechecked "bythemethoddescribedinAnnexII.
Article4
Amendments "toadapt"theAnnexesto"thisDirectiveinaccordancewithdevelopmentsinscientificandtechnicalknowledgeshallbeadoptedinaccordancewith
theprocedurelaiddowninArticle10oftheDireotive76/.../EECof
22November1976.
Article5
ThisDireotiveshallnotaffectnationalprovisionsrelatingtootherpossiblestandardsprovidedforinArticle3oftheDirective76/.../EECof2.2November1976.
Article6
1.TocomplywiththeprovisionsofthisDirective,theMemberStatesshall,wherenecessary,amendtheirrespectivelawsby1January1978andinformtheCommissionforthwith.
2.Thelawsasthusamendedshallbeappliedwitheffectfrom1July1978bothtomaterialsandarticles,andtofoodstuffswithwhichsuchmaterials
andarticleshavecomeintocontact.
Article7
ThisDireotiveisadrassedtotheMemberStates.

ANNEXI
Limitsofvinylohloridemonomerinmaterials,articlesandfoodstuffs
Materialsandarticles:1mg/kginthefinalproduct.However,inthecaseofmaterialsandartioles
preparedwithvinylchloridecopolymers
andnotintendedforuseinpackagingor
containingliquidsforhumanconsumption,thelimitshall"be5mg/kg.
Poodsturfsî 0.050mg/kg.

5«
AfflîOC II
T.-e-tsmln.'-xt ionefv^rryl cMoride (VCÌmoaomer inmaterials .articl<>s anA
ioods cuf13
Principle
Thepresence ofVCinfoodstuffs ,materials orarticles isdetermined bymeana
ofgas–liquid chromatography using the"head space "method after solution
orsuspension of thesample indimet hylao etamida(DMA).
2.Reagent s
2.1 VC,ofpurity greater than 93.5% .
2.2 K-IT DMA ,notcontaining anyvolatile impurity ,withthesame
chromatography retention time asVC.
2.3 Anyappropriate internal standard solution ,such asdiethyl etherinDMA .
3»Apparat us
M. Aninstrument orpiece ofapparatus ismentioned only ifitis
special ormade toparticular specifications ;usual laboratoryapparatus isassumed tobeavailable .
3.1 Gas chromatograph fitted withanautomatic head-space sampler and
A-vsme ionization detectors .Alternatively ,agaschromatograph fitted
manual sample injection andequipped with aflame ionization
detector maybeused .Ithasalsobeenfound that itissatisfactory
touseaspecific detector inthegaschromatograph instead ofaflame
ionization detector ,e.g. ,amicro–electrolytic conductivity detector
oftiiekind described intheJournal ofChromatographic Soience .
Vol .12(March 1974 ),p.152.
3«2Àc,otentiometer «
3-3 Sample phials orflasks fitted with asilicone orbutyl rubbersept .MB.

When using themanual technique ,thetaking ofasample inthehead
space bymeans ofasyringe maycause theformation of&partial vaouum
inside thephial orflask .Hence ,formanual techniques where thephials
arenotpressurized before thesample istaken ,theuseoflarge phials
iBrecommended .
3.4 Micro-syringes .
3.5 Gaslight syringeB formanual head–space sampling .
4.Prooadore
4.1 Preparation ofstandard VCsolution
NB.VCmust behandled inaventilated fume cupboard .
Weigh asuitable glass vessel accurately andplaoe initaquantity
(e.g. ,30ml)ofDM.Reweigh .AddtotheDMAaquantity ofVC
(e.g. ,0.1mg)inliquid orgasform ,inthelatter casebybubbling in
orinjecting .After again reweighing ,calculate from thedifference the
quantity ofVCinsolution andhence theconcentration ofthesolution
obtained (standard solution ). This standard solution will keep fora
long time ifstored inarefrigerator .
Prepare adilute VCsolution bytaking analiquot ofstandard solution
andadding ittoapredetermined quantity ofDMAoontained inanalready
tared glass phial ,atthesame time reducing thevolume ofair (head
spaoe )asmuch aspossible .Reweigh andcalculate theVCoonoentration
bydifference .
4.2 Preparation ofsample
NB.Take allthenecessary precautions toensure that noVCislost
through volatilization .
Take samples offoodstuffs ,materials orarticles insuch awaythat they
arerepresentative oftheproduct under investigation .Forthis purpose ,
intheoase ofnon-liquid foodstuffs ,homogenize thesamples under
investigation accurately before taking analiquot .

4.2.1Foodstuffsample
WeighaccuratelyintoeachofaBetofthreephialsasuitablequantity
offoodstuffunderinvestigation .Ifconsiderednecessary,addan
appropriatequantityofDMA(thissometimespromotestheattainmentofastateofequilibrium)and/oroftheinternalstandard.Seal
Immediately andhomogenize.
4.2.2Calibrationcurveforthedetermination ofVGinfoodstuffs
Weighintoeachofasetofnotlessthanfivephialsaproportionate
quantityofthesamefoodstuffwhichhasneverbeenincontactwithmaterialsorarticlescontaining VC.IfsomeDMAand/orsomeofthe
internalstandardhasbeenaddedtothefoodstuffsampleundersection4*2.}.,add
proportionate quantitiestoeachreferencesample.
Finally,adddilutedstandardVCsolutioninquantitiessuchasgive
VCconcentrations equalto0.000,0.050,0.075»0.100,0.150,etc.,
mg/kg.Sealimmediatelyandhomogenize.
4.2.3Sampleofmaterialandarticle
Weighaccuratelyintoeachofaset01threephialsabout200mg
ofthematerialorartiole,sampledfromtheproductunderinvestigation
andreducedtosmallsize.Insertamagneticstirrerandabout
2mlofDMAcontaining,ifconsideredneoessary,anappropriate
quantityofinternalstandardsolution.Sealthephial,suspenditin
awaterbathheldat60-70Canddissolvethesamplebystirringthe
solutionvigorously.
4.2.4Calibration curveforthedetermination ofVCinmaterialsor
articles
Placeabout200mgofamaterialorartioleofthesametypeas
describedinsection4*2.3,notcontaininganydetectableamountofVC,
ineachofasetofnotlessthanfivephials.Insertamagnetic
stirrerandaddabout2mlofDMAcontainingasuitablequantityof
internalstandard,ifthishasbeenusedundersection4*2.3*

Dissolvethematerialorarticlebystirring.AdddilutedBtandard
VCsolutioninquantitiessuchaagivearangeofooneentrations
comprisingtheconcentration oftheVCinthesampleunderinvestigation .
Sealimmediately andhomogenize.
4.3Gaa-chromat ographydetermination
4.3.1Bringthesampletoastateofequilibrium
Allowthesamplescontainedinthesealedphialsasufficienttimeto
attainastateofequilibrium "beforebeginningthehead–spacesamplingoperation.Aperiodoftwohoursat50°Cisusuallysufficientfor
thispurpose.
4»3»2Determination
Chooseagas-chromatographycolumnandoperatingconditionssuch
thattheproduotunderinvestigation doesnotinterferewiththe
VCor,ifapplicable,withtheinternalstandard.Periodically
flushthecolumnsoastoeliminate DMApeaksfromthechromatogram .
Measi-rethearea(orheight)ofthepeaksrepresentingtheVCor
theinternalstandard,ifused,anddeducetheVCconcentration of
thesaraplooffoodstuff,materialorarticleunderinvestigation
fromtheconstructed calibration curves.
4.4Interference peaksonthechromatogras?s
Certainfoodstuffsgiverisetointerference peaks.Inthatevent,
confirmthat¥0isactuallypresentinthefoodstuffsample,either
byusingamicro-electrolytioconductivity detectorasmentioned
insection3.1orbymeansofmassspectrometry.Inthisevent,
thefactthatmolecularionswithparentmasses(a/e)of62and64
arepresentintheratioof3*1isregardedasconfirmingthat
VCispresent.Ifsuchinterferenceisconfirmed,useadifferent
column.