ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(81)69
Vol.1981/0020

Disclaimer
Conformément aurèglement(CEE,Euratom)n°354/83duConseildu1erfévrier1983
concernantl'ouvertureaupublicdesarchiveshistoriquesdelaCommunauté économique
européenne etdelaCommunauté européenne del'énergieatomique(JOL43du15.2.1983,
p.1),telquemodifiéparlerèglement(CE,Euratom)n°1700/2003du22septembre2003
(JOL243du27.9.2003,p.1),cedossierestouvertaupublic.Lecaséchéant,lesdocuments
classifiésprésentsdanscedossierontétédéclassifiés conformément àl'article5dudit
règlement.
Inaccordance withCouncilRegulation(EEC,Euratom)No354/83of1February1983
concerningtheopeningtothepublicofthehistoricalarchivesoftheEuropeanEconomic
Community andtheEuropeanAtomicEnergyCommunity (OJL43,15.2.1983,p.1),as
amendedbyRegulation(EC,Euratom)No1700/2003of22September2003(OJL243,
27.9.2003,p.1),thisfileisopentothepublic.Wherenecessary,classifieddocuments inthis
filehavebeendeclassified inconformitywithArticle5oftheaforementioned regulation.
InÜbereinstimmung mitderVerordnung(EWG,Euratom)Nr.354/83desRatesvom1.
Februar1983überdieFreigabederhistorischen ArchivederEuropäischen
Wirtschaftsgemeinschaft undderEuropäischen Atomgemeinschaft (ABI.L43vom15.2.1983,
S.1),geändertdurchdieVerordnung (EG,Euratom)Nr.1700/2003vom22.September2003
(ABI.L243vom27.9.2003,S.1),istdieseDateiderÖffentlichkeit zugänglich.Soweit
erforderlich,wurdendieVerschlusssachen indieserDateiinÜbereinstimmung mitArtikel5
dergenanntenVerordnungfreigegeben.

COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(81)69 final
/C'" !^
Brussels ,26th February 1981
/.- < ' \ r-4,
r■■:■
V- ••"7\^ iY •/v
PROGRESS REPORT ONNEGOTIATIONS
BETWEEN THE EUROPEAN COMMUNITY AND THE UNITED STATES
AUTHORITIES ONTHE CONTROL OFTOXIC SUBSTANCES
(COUNCIL MANDATE OF30MAY1978 )
(Communication ofthe Commission tothe Council )
COM (81)69final

COMMUNICATION OFTHE COMMISSION TOTHE COUNCIL
Progress report onnegotiations between theeuropean Community andthe
United States Authorities onthe control oftoxic substances (Council
mandate of30May 1978 )
On30May 1978 the Council authorized the Commission toopen negotiations
with theUnited States ofAmerica with aview toinvestigating means ofar­
riving atanagreement ontheprocedures forapplying theToxic Substances
Control ActtoCommunity products ,and thecorresponding Community legisla­
tions toproducts from theUnited States .^
Inparticular thenegotiations were tocover thefollowing topics :
1.Theharmonization ofcategories andmethods for thenecessary tests for
theevaluation oftoxicity ,ecotoxicity and the impact ontheenviron­
-ment ofchemical substances ;- /
ι ·
2.Themutual recognition ofthebasic data required toestablish the noti­
fication dossier ;
3.Themutual accreditation oflaboratories responsible forcarrying out
thetests andtheverification ofresults ;
4.Theestablishment ofprocedures fortheevaluation ofrisks tohuman
\
beings andtheenvironment caused bychemical substances ;
Theapplication oftheToxic Substances Control Actand ofthecorrespon­
ding Community legislation tochemical substances contained both inma­
nufactured products arid inpreparations ;
6.Theprocedures forensuring themutual respect oftheconfidential natu­
reofcertain data ; "" .
7.The laws ofthe individual States ofthe United States ofAmerica versus
federal lawregarding controls ofchemicals substances ;
8.Methods ofapportioning thecosts arising from theimplementation ofthe
Toxic Substances Control Actandoftherelevant Community legislation ;
9.Theestablishment ofpriority lists ofvexisting chemical substances which
could well bethesubject ofspecial monitoring andcontrol measures ;

10.Theharmonization ofinventories ofchemical substances ;
11.Thestudy -ofthepossibilities forco-operation inthefield ofresearch .
Thepresent document isareport •from theCommission ,,approved ,bythe'group of
representatives ofMember States atits13th meeting on .3-4November •1980 .
"v *
•k it
Over the last twoyears there have been sixmeetings between theCommission
andtheAmerican Authorities responsible forimplementing theTSCA DInprepa­
ring for these meetings the Commission wasassisted byrepresentatives ofmem­
berStates ;theoutcome offourteen meetings between the Commission and this
group ofrepresentatives hasbeen aseries ofeleven .papers setting outthe
EEC'sobservations onvarious rules proposed toimplement theTSCA (1).
This work hasmade itpossible toclarify for theAmerican Authorities the
Community position onthecontrol ofchemical substances ,andtheprocess has
shoown howimportant itisforthetwoparties toenter into adialogue .
The adoption bythe Council on18September 1979 ofthe sixth amendment tothe
1967 Directive ondangerous substances <2)has,ononehand ,given more weight
totheCommunity intervention and on'theother hand ,ledtheUnited States to
give more importance tothedialogue with the EECwith aview toharmonizing
asfar aspossible their approaches onthequestion ofcontrolling chemical
substances . !
Theexistence andthe results ofthese bilateral meetings have gradual lyinfluen­
cedthe work carried out intheframework oftheChemicals Programme .in0EC0 ,
where marking progress hasbeen achieved .This progress has been put inconcre­
teform atthe high .level meeting held inParis on19-21 May1980 .
(1)See Annex I
(2)Council Directive of18September amending forthesixth time
Directive 67/548/EEContheapproximation ofthe laws ,regulations and
administrative provisions relating totheclassification ,packaging and
labelling ofdangerous substances (Directive 79/83.1/EEC,0JL259 of
15October 1979 )„

Harmonization ofapproaches andpractices mayberegardedashavingbeen
achievedonthreeofthesubjectsdefinedinthetermsofreferenceissuedby
theCouncilon30May1978.Theseconcerntestingmethods/theminimalpre-
marketingsetdata(MPD)andtheprinciplesofgoodlaboratorypractice(GLP).
-Testingmethods:fornewchemicalswhichhavetobenotified,anagreement
hasbeenreachedwithinthe'OECD.Thetestingguidelines developed byOECD
shouldbeononehandincorporated intoAnnexVofthe6thAmendment and
ontheotherhandimplemented bytheUSEnvironmental Protection Agency.
-Minimalpremarketing setofdata(MPD):itsusewillnotbedifficultat
EEClevel,.asthe6thAmendmentalready,imposestheuseofasimilarset
(initsannexVII). '
~TheUnitedStatesapproved MPDinprincipleatthehighlevelOECDmeeting
heldinParison19-21May1980/inspiteofthefactthatUSlawmakesno
suchprovision.ButfortheEEC,itis,importantthatthisworkbepursued
rapidlyandefficiently todevelopacompletstepsequencetestingsystem
(Stufenplan).
-Goodlaboratorypractice:theprinciples ofGLP/drawnupbytheOECD/
havebeenacceptedbytheEECandtheUnitedStates.Nevertheless thepro­
blemofmonitoring enforcement oftheprinciples remainsanddiscussions
onthispointmustcontinue.TheEECshouldstandfirmandinsistthatin­
ternationally acceptable monitoring systemsbedeveloped andthatthe
countries belefttodecidewhichsystemstheyarebestabletoimplement.
Ittherefore seemsthatonthesethreetopicstheEECwillhavenodifficul­
tyinimplementing thedecisionstakenwithaviewtoharmonizing approaches
andpractices onthecontrolofchemicalsubstances .TheAmericanAuthorities
ontheotherhandwillhaveproblemsastheyhaveapprovedprinciplesfor
whichthereisnoprovisionintheirlegislations .;TheEECwilltherefore have
tocontinuetopresstheUnitedStatestoactuallyimplementtheseprinciples .
Moreover/intheUnitedStatesaproblemstillremainswithregardtosec­
tion4oftheTSCAwhichprovides'forthepromulgation oftestingrules.
Inconnection withthesetestingrules/theEPAwantstoimposestandardized
methods(testingstandards)/whichdifferfromtheOECDguidelines .Ifthe
EPAfinalizesthesetestingstandards/itwillagainputinternational harmo­
nizationinquestion.
\

Ontwofurthertopics ,listedintneCouncilmandateof30MayT978theharmo­
nizationprospectsalsoseemtobefavourable .Discussions arecurrentlyta­
kingplaceonriskassessment methods,bothbilaterally andinOECD.Forthe
sharingofcostsarisingoutofthetestingofnewsubstances,theEPAisco­
mingrciundtotheEEC'spointofview,i„e.toleavecompaniestoregulatethi:
typeofproblemamongthemselves .
TwoquestionsraisedbytheEECmayberegardedasprovisionally settled.
TheAmericanAuthorities havedecidednottorequirethe^systematicnotifi­
cationofnewchemicalsincludedinmanufactured products;theywilldecide
onacase-by-casebasis.Theyhavealsorejectedthepossibility thataState
lawcouldtakeprecedence overfederallaw(TSCA).
Nevertheless theTSCAtextonthesetwopointscontradicts theassurancegi­
venbytheAmericanAuthorities .TheEECcannotthereforeyetregardthesemat­
tersasfinalized . '
Concerning theinventoryofexistingchemicalsubstances,thereisamajor
difference betweentheCommunity andAmericanapproaches .TheAmericaninven­
toryisdynamic;i.e.newsubstances areaddedtothelistuponnotification
toEPA.TheCommunityinventorywillonlylistthosesubstances whichwillbe
ontheEECmarketon18September 1981.Bydefinition,thesetwoinventories
cannotbeharmonized;howevertheEECbenefitsfromtheamericanexperience
inthisfield.
Therearetwomajorproblemsahead.Theyarethequestionofconfidentiality
andthedrawingupofprioritylistsofexistingchemicals whichshouLdbethe
objectofspecialtesting.Theproblemofensuringtheconfidentiality ofda­
taremainsthemosturgentandtheonemostdiffic#kttoresolve.Itwillbe
necessarytoreconcile twodifferentlegalsystemsaswellastheinterests
ofindustryandofthegeneralpublic.TheEPAhasbeenapplyingSection5
oftheTSC/^whichrequiresnotification ofnewchemicalsubstances,since
July1979.From18September 1981notification willberequiredintheEECun­
derthe6thAmendment.Consequently everyeffortwillhavetobemadetohar­
monizetheconfidential treatmentofdatasubmitted bynotifiers.

Concerning thepriorityListofexistingchemicalsubstances whichshould
betheobjectofspecifictesting,theCommunityshouldinvestigate with
theUnitedStatesharmonizing thecriteriaforselectingsubstances .It
willbemoredifficulttoharmonizethecontentsofthelistsasinorderto
determinewhetherasubstanceshouldbeexaminedurgentlyseveralfactors,
whichvaryfromcountrytocountry,havetobetakenintoaccount:popula­
tiondensity,geography,thecost/benefitratio,etc.
Theconsequences fortheEECoftheUnitedStatesdrawingupapriorityList-
shouldnotbeunderestimated since,ifalistisestablished,theEPAcould
wanttohavethecostsofthetestsitimposesshared.Inadditionthe
Americanauthoritieswillcertainlyconsiderwinningacceptancefortheir
prioritiesintherelevantinternational fora.
Inadditiontothe11pointsofnegotiation :individuallystatedinthe
Councilmandateof30May1978,thereareothers,implicitely coveredbythe
\ · · .
samemandate,whichhavebeentheobjectofdiscussions .Oneexampleisthe
labellingofchemicalsubstances,aboutwhichtheEEC'hasinformally communi­
cateditspointsofviewtotheAmericanauthorities,whileawaitingthepu­
blicationofcertaindetailsoftheAmericanproposedrule.
* X
Thus,therearefavourable developments asregardsharmonization oftheapr;
proachesoftheCommunity andtheUnitedStatestothecontrolofchemical
substances (testingmethods,MPD,GLP,sharingofcosts,riskassessment).
However,toensuretheelimination ofallbarrierstointernational tradein
chemicalproductswhilstatthesametimemaintaining theoriginalobjectives
ofprovidingeffectiveprotectionformanandhisenvironment,negotiations
mustcontinue,particularly onprioritysubstances andtheconfidential treat­
mentofdata.Moreover,itcannotbeignoredthatcertaintoxic-substances
(forexample,asinmanufactured products)generallycoveredbyTSCA,could
beregulated morestrictlyunderotherlawssuchastheFederalHazardous
Substances ActortheConsumerProductSafetyAct,withseriousconsequences
forCommunityimportsintotheUnitedStates.
Therefore,itappearsnecessarytodiscusswiththeAmericanAuthorities the
difficulties whichcouldarisefromapplyinglawsotherthanTSCAtotoxic
substances .

Annex I
-
List ofdocuments "Aide-memoire transmitted bytheEuropean Community to
theEnvironmental Protection Agency oftheUnited States with respect to
proposed rules fortheimplementation ofthe Toxic Substances Control Act".
I.ENV/595/78,22.9.78 :
EPAPreliminary draft guidance forpremanufacture notification under TSCA .
II.ENV/672/78,26.10.78 :
Further comments onTSCA guidance forpremanufacture notification (draft
document of12September 1978 ).
III .ENV /183/79-19.3.79 :
Comments ofthe European Community ontheproposed rules forTSCA section 5
(Fed .Reg .vol.44,p.2242 et.seq .,10January 1979 ).
IV.ENV/353/79,6.6.79 :
Comments ontoxic substances control:"Discussion ofpremanufacture policy
andtechnical issues "(Fed .Reg .vol .44,p.16240 etseq.,16.3.79 ).
V.ENV/430/79,31.7.79 :
Comments on"Proposed Health Effects Standards for TSCA Test Rules and
"Good Laboratory Practice Standards forHealth Effects "(Fed .Reg .vol.44 ,
pp.27337-27362 and pp.27362-27375 ,9.5.79 ).
VI.ENV/62ï/79,2.10.79 :
Comments ofthe European Community on"Proposed Health Effects Test
Standards forToxic Substances Control Act Test Rules andProposed Good
Laboratory Practice Standards forHealth Effects "(Fed .Reg .vol .44,
pp.44054-44093 ,26.7.79 ).
VII .ENV/692/79,14.11.79 :
Comments ofthe European Community on-Data Reimbursement under sections
4and 5oftheToxic Substances Control Act (Fed .Reg .vol .44,
pp.54284-54290 ,18.9.79 ).
VIII .ENV/732/79,23.11.79 :
Comments ofthe European Community onthe Reproposal ofToxic Substances
Control ActPremanufacture Notice Forms andProvisions ofRules (Fed .Reg .
vol .44,pp.59794-59882 ,16.10.79 ).

Annex I
IX.ENV/I/316/80,6.5.80 :
Comments ofthe European Community on Policy Statement under the Toxic
Substances Control Act for Import ofChemical Substances "(EPA draft
proposal of12.3.80 ).
X.ENV/837/80,december 1980 :
Comments ofthe European Community onthe Proposed !Production Restrictions
ofOzone-Depleting Chlorof luorocarbons (Fed .Reg .vol .45,pp.66726 -
66734 of7October 1980 ).
XI.ENV/960/80,9.1.81 :
Comments ofthe European Community ontheProposed Environmental Test
Standards andProposed Good Laboratory Practice Standards forPhysical ,
Chemical ,Persistence andEcological Effects Testing (Fed .Reg .vol .45,
pp.77332-77365 ).