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COM(76)312
Vol.1976/0095

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(76)312final.
i
Brussels.24June1976#
ICOMMUNICATION FROMTHECOMMISSIONTOTHECOUNCIL
concerningtheobjectiveevaluationoftheriskstohuman
healthfrompollutionlaysomepersistentorgano-chlorine
compounds
\ ί
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i
COM(76)312final,\
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General
1.IntheProgramme ofAction ontheEnvironment *(Part II,Title I,
Chapter 1)organo-halogen compounds areconsidered asfirst cate­
gory pollutants forpriority investigation .
TheCommission isrequired tosubmit totheCouncil theresults of
itswork ontheobjective evaluation oftherisks tohuman health
andtotheenvironment from pollution bytheorgano-halogen compounds .
This communication covers thevarious aspects outlined and con­
tained intheabove mentioned chapter oftheAction Programme .It
seeks toestablish theconsequences topublic health oftheuseof
these compounds andtherefore does notdeal with theconsequences
totheenvironment norwith thelegislative procedures already
taken orinthecourse ofbeing considered bytheCouncil ofMinisters .
2.TheCommission was asked toundertake asquickly aspossible the
following tasks :
compilation ofascomplete abibliography aspossible onthe
effects ofthepollutants under consideration and acritical
analysis ofthis information ;
- determination ofcriteria for certain pollutants ;
- standardization orharmonization ofthemeasuring methods and
instruments ,soastorender theresults ofpollution measure­
ments intheCommunity comparable .
3.After aninitial evaluation oftheproblems involved itwasdecided
to :
limit the studies tothemost significant organo-chlorine
compounds forwhich sufficient data isavailable
deal with ecological criteria separately ,
- study theother organo-halogen compounds asandwhen suffi­
cient data becomes available .
4.Toperform this work theCommission has :
held meetings ofnational experts ,
- made anoverall survey oftheavailable information forthe
period from 1968 to1972 onthepollution levels ofthose
persistent organo –halogenated compounds measured in:
- various environmental media and infoodstuffs
inhuman fats and inmaternal milk .
* O.J. C112 of20.12.73
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- pejrfesrmefl aeellabeg'afeive ertejf@i§e InfeRQ 8fefcej?minati©n ef
organochlorine residues inbiological materials ,
carried out apreparatory study for establishing criteria for
humans for organochlorine compounds i.e. pesticides and their
metabolites .
organized aEuropean colloquium onthe "Problems raised bythe
contamination ofman andhis environment bypersistent pesti­
cides andorgano-halogenated compounds ".
5.This communication isinthenature ofaninterim report which
summarises the results ofthe tasks sofarperformed .Alist of
the reference documents that have been used for this communication
isdetailed inthe annex .
6.This report contains the following main sections :
I The content oforgano-halogen compounds inwater ,air and
foodstuffs andmethods ofanalysis .
II Comparability ofanalysis methods .
III Pesticide resiaues inhuman tissues .
IV Criteria (Dose /Effect Relationships )forhumans .
V Conclusions .
I The content oforgano-halogen compounds inwater ,air and foodstuffs
andmethods ofanalysis
1.The study entitled "The content oforgano-halogen compounds detec­
ted between 1968 and 1972 inwater ,air and foodstuffs and the
methods ofanalysis used inthenine Member States oftheEuropean
Community ",(1ofAnnex )gave priority consideration tothe fol­
lowing list ofcompounds :
Dieldrine (HEOD )
DDT (pp'DDT +op'DDT )+DDD (pp'DDD orTDE )+DDE (pp'DDE )
Aldrine (HHDN )
Hexachlorobenzene (HCB )
Lindane (yBHC )
PCB
Heptachlor
Heptachlor epoxyde
BHC (a,$and 6)
2.Organo-chlorine pesticide residues arepresent inthe air ,water
and soil ofEurope ,aswell asinmost ofits foodstuffs ofanimal
and vegetable origin .
3.Because oftheir persistent nature andapplication andthepriority
accorded tothem insurvey work ,yBHC ,DDT and itsmetabolite DDE ,
anddieldrin are themost frequently quoted organochlorine pesti­
cides ofthose mentioned inthis study .
4.Ithas been shown that thedust inthe air invarious places in
Europe contains traces ofthe insecticides dieldrin and DDT
inamounts varying between 0.0001 and 0.001 yg/kgdust .Rain­
water ,like large rivers which are constantly discharging these
residues into the sea ,can contain levels which are ahundred times
greater .Analyses ofunderground waters have produced ingeneral
negative results except when accidental pollution has taken place .
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Because ofthe sea sdilution capacity andofitsvarious tidal
movements ,measurement findings onconcentration levels are often
negative ;nonetheless ,the presence ofthese residues inhigh
levels ,varying from afewhundredths ofamg/kgtoseveral mg/kg,
found insalt-water fish isindicative oftheir presence inthe
sea .
There isinsufficient data available concerning marine sediments ,
although data from Belgium showed residues ofyBHC ,dieldrin ,
endosulfan ,DDE and DDT present inNorth Sea sediments .
5.Aslarge amounts ofDDT ,etc .accumulate inside fish which have
lived inwaters containing very small traces ofpersistent organo­
chlorine pesticides ,there isaneed for carefully following the
situation with regard totheconcentration ofthese pollutants in
the aquatic food chain .
6. Inview ofthe different efficiencies ofconventional methods for
the removal oforganochlorine traces from waters which are destined
tobeused for the production ofdrinking water ,these waters
should beprotected against pollution byorgano-chlorine compounds
and adequately monitored .
7.DDT inparticular ,although not regularly used infruit andvege­
table growing ,occurs inexceptionally high amounts inasmall but
consistent proportion ofsamples ,indicating clearly the inter­
mittent ,and substantial presence ofthis pesticide infoodstuffs .
The treatment offruit and vegetables byorganochlorine pesticides ,
which iscarried out inthe world 'sfields and orchards ,makes
these foods potential vectors ofthese compounds .Despite the
efforts oflaboratories invarious countries ,themonitoring which
iscarried out isfar too limited considering thevolume oftrade
inthese perishable foodstuffs ,which come from many different
places andwhich arepart ofourdaily diet inEurope .
8.The levels reported infoods from thevery restricted surveys
cannot beconsidered representative oftheoverall situation par­
ticularly aslocal conditions are subject tochange .
Nevertheless ,they doshow that thetolerances atpresent inforce
intheMember States are rarely exceeded .
9.The use ofaldrin ,dieldrin andheptachlor inthe treatment of
soils resulted inthese pesticides ,especially dieldrin ,being
found inroot vegetables and potatoes and consequently indairy
produce andmeat .The use ofdieldrin was discontinued when
residues were observed ,but noexact determinations were made of
theamounts present infruit andvegetables .
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10.Studies onpoultry and eggs revealed that the feeding-stuffs used
inpoultry rearing were amajor cause oftheir contamination ."
Dairy products andmeats are still aregular source oforgano­
chlorine pesticide residues inthe diets ofEuropeans ,and indicate
partly the effects ofcontaminated animal feeding stuffs .As
these feeding-stuffs are asource oforganochlorine compounds ,they
should besubjected toadequate monitoring andwhen imported to
strict entry conditions .The same applies toimported food direct­
lyconsumed byhumans ,such ascocoa and imported cereals .
11.Aninventory ofthemethods ofanalysis used fororganochlorine
residues infoodstuffs and environmental media showed that several
techniques were inuse asaresult ofnumerous factors such asthe
availability oflaboratory equipment and theorientation ofindi­
vidual laboratory research .
II Comparability ofanalysis methods
1.The study entitled "AEuropean Community study onthedetermination
oforganochlorine pesticide residues infatty "materials "(2of
Annex ),took the following organo-chlorine compounds into account :
Hexachlorobenzene (HCB )
a-,$-andyhexachlorocyclohexane (HCH )
Dieldrin
Heptachlorepoxide (HEPO )
p.p'-DDE
TDE (=p.p'-DDD )
O.p'-DDT
p.p' -DDT
(aldrin ,heptachlor ,chlordane andendrm were considered tobeof
noimportance for thepurpose ofthis study ).
2.From aquestionnaire onanalytical methods itappeared that essen­
tially five different methods were inuse among theparticipating
laboratories .There was noreason tosuppose that one ofthose
methods was superior toany ofthe others for thedetermination of
theHCH-isomers ,dieldrin ,HEPO and theDDT-complex .For the
determination ofHCB ,however ,methods using liquid-liquid parti­
tioning intheclean-up step could give rise toerroneous results .
3.Theanalytical methods forspiked samples showed fair togood
reproducibility fora-HCH ,B-HCH ,dieldrin ,HEPO ,p.p'DDE ,o.p'DDT
andp.p'DDT ,but there was poor reproducibility forHCB .
4.The limits ofdetection reported bythedifferent laboratories
ranged from 0.005 ppm forHCB to0.08 ppm forp.p'-DDT .Most
laboratories reported 0.01 ppm astheir limit ofdetection ;
higher detection limits were reported more specifically bylabora­
tories involved inregulatory ormonitoring programmes where quick
screening ofmany samples ontolerance level was required rather
than high sensitivity .
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5.From thestudy onthemarket samples ofrendered beef andpork fat
itfollowed that onthe low levels found relatively large variation
coefficients occurred .This situation was toberegarded as
normal for concentrations near the limit ofdetection .
III Pesticide residues inhuman tissues
1.The study entitled Pesticide residues inhuman fat and human milk
inthenine Member States oftheEuropean Community (1969-1973 )",
(3ofAnnex ),give priority consideration tothefollowing list of
compounds :
Dieldrin (HEOD )
DDT (ppDDT +op 1DDT )+DDD (pp'DDD orTDE )+DDE (pp'DDE )
Aldrin (HHDN )
Hexachlorobenzene (HCB )
Lindane ("yBHC )
PCB
Heptachlor
Heptachlor epoxyde
BHC (a,3and
2.The levels ofDDT and metabolites ,dieldrin ,the isomers ofBHC and
heptachorepoxide ,found inthe fat ofthepopulation oftheMember
States did notdiffer greatly from theusual levels ofpopulations
outside theEuropean Community .
■The level ofDDT isinvariably lower than the levels found in
experiments conducted involunteers which have been shown tobe
tolerable without causing any clinical symptoms and signs .
3.The data mentioned above justify theconclusion that there isno
immediate risk totheinhabitants ofEurope intheform ofreadily
identifiable biological damage .However ,amore detailed and
elaborate survey intheyears tocome would beadvisable tofurther
evaluate the risk including thepossible long term ordelayed
effects .
4.The evaluation ofthe effects ofsubtoxic doses requires more
information ,especially with regard toenzyme induction inhuman
and animal tissues ,aswell asneurological andpsychological
effects .These effects should bestudied for the organochlorine
compounds separately and incombination .
5.Determining organochlorine pesticide residues inhuman fats would
seem tobeavalid method ofdepicting the exposure ofagiven
population toorganochlorine pesticides .Astotheorigin of
these deposits itisgenerally accepted inthe literature that
organochlorine compounds found inhuman beings originated from food
intake .However ,adirect correlation between the residue levels
inhuman fats and the exposure through food cannotbedrawn .
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6.Due tothevariety oftechniques used tocollect fat samples ,to
different methods ofpreparing samples ,todifference inthe social
strata inwhich sampling was carried out and todifferences intype
ofemployment ,health ,sex and age ,only tentative comparisons of
the assembled data could bemade .
Anindication oftheanalytical problems isfound intheresults of
the intercomparison programme runwith some fat samples offood .
However these data doprovide astarting point for anEuropean
survey based onstandardized methods ofsampling and sample prepa­
ration ,ofanalytical methods and random selection ofsurvey subjects .
These data will permit abetter assessment tobemade and will show
the trends inthe levels oforganochlorine compounds inhuman
beings .
IV Criteria (Dose /Effect Relationships )forHumans
1.The definition ofcriteria establishing the relationship between a
given exposure and anobservable effect onhuman health isan
important element inthe objective evaluation oftheundesirable
effects ordangers inherent inany given nuisance .
Analysis ofcriteria permits inparticular the identification of
the levels ofpollution ornuisance which have certain undesirable
orharmful effects onman .
2.The study entitled "Preparatory Study forEstablishing Criteria
(Dose /Effect Relationships )forHumans onOrganochlorine Compounds ,
i.e. Pesticides and their Metabolites "(4ofAnnex )considered the
following substances :
DDT and its metabolites
Aldrin ,Dieldrin and Endrin
Heptachior andheptachlor epoxide
Chlordane
BHC and Lindane
3.Exposures much higher than occurs inthegeneral population take
place inthose occupationally exposed . Ill effects have been
observed inanumber ofindividuals accidentally exposed tohigh
dosage levels ofcertain ofthe above pesticides .Such effects
have included neurological ,dermatological ,hematological and
hepatic abnormalities but these effects described forcompounds
other than lindane need confirmation .Usually full recovery took
place when theexposure ceased .
4.Itisrecognised that severe weight loss due to,forexample ,
famine orill health can increase blood levels ofthe above men­
tioned organochlorine pesticides intheEuropean Community .
Poisoning from such anoccurrence isconsidered unlikely .
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5.The results ofchronic toxicity experiments inanimals cannot
always beextrapolated directly andhave notyetbeen confirmed in
man .However ,animal experiments doconfirm the acute effects .
When the above mentioned compounds are administered tovarious ■
animal species theactivity ofhepatic microsomal metabolizing
enzymes isincreased .Such aneffect has not been demonstrated in
man atthe levels ofpesticides towhich heiscurrently exposed .
High dosages have been shown toproduce liver enlargement with
histological changes inthehepatocytes inexperimental animals .
Long-term feeding studies have shown that hepatic tumours are
produced inmice bychlordane (recent review ),DDT ,aldrin ,diel­
drin ,BHC andheptachlor ;some ofthese tumours have shown malig­
nant changes .There isaconsiderable controversy about the
possible significance forman ofthe tumourogenic effect inmice of
these compounds .
DDT and itsmetabolites have been shown tobemutagenic using
certain test systems ;other test systems have yielded negative
results .Although these substances have been shown toincrease
perinatal mortality inexperimental animals ,noteratogenic effects
have been observed .
V Conclusions
1.Because ofthe difficulties ofinterpreting the data from experi­
mental animals ,and the lack ofsufficient data onthe long-term
effects onman itisnotpossible atthepresent time todraw up
criteria relating the levels towhich man isexposed topossible
effects .
Toachieve this aconsiderable amount ofresearch may beessential
ifman'sexposure tothese pesticides justifies it.Careful
consideration should begiven tosuch arequirement atthepresent
time inview ofdecreasing usage .Such research should bedirec­
ted towards those organochlorine compounds which are likely tobe
increasingly used inthefuture .
2.Apart from thepresence oforganochlorine pesticides inthefatty
tissues ofthebody ,noabnormalities have been demonstrated inthe
general population intheEuropean Community which aredirectly
attributable tothepesticides .
3.Present information from Member States indicates that because of
controls ,theusage ofthese persistant organochlorine pesticides
andman'sexposure tothem isdecreasing .Nevertheless ,because
ofthe difficulties and uncertainties mentioned above concerning
toxicological evidence inrelation tothese products ,itiscon­
sidered that
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– adecreased usage ofanyofthese persistent organochlorine
pesticides should berecommended within theEuropean Community ,
thestrict control ofemissions oforganochlorine compounds
should take place ,
andthecontrol ofresidues oforganochlorine compounds in .
food andanimal feeding stuffs should bereinforced .
4.Toverify that usage andlevels ofexposure continue todecrease ,
itisconsidered that appropriate periodic monitoring should take
place .
5.Intheabsence ofcriteria theattention oftheMember States is
drawn totheusefulness oftheEstimate ofthesafe level ofintake
ofthese compounds (Acceptable Daily Intake orADI )drawn upbythe
FAO/WHOWorking Party ofExperts onPesticide Residues inFood .
TheCommission hasalready taken these into account inpreparing
itsProposal foraCouncil Directive relating tothefixing of
maximum levels forpesticides inandonfruit andvegetables .
Thought should begiven inthefuture totheuseofsuch ADI'sand
tothepossibility ofutilizing other concepts (forexample ,blood
andother tissue levels )forexpressing safe levels ofexposure to
such pesticides .
6.Inconsidering ontheonehand therequirements laid down inthe
Environmental Action Programme ,andontheother hand thediffi­
culties anduncertainties mentioned above ,theCommission will
continue toreview andassess theinformation available with regard
totheproblems discussed inthis interim report .
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Annex
Reference Documents
1.The content oforganohalogen compounds detected between 1968 and
1972 inwater ,air and foodstuffs and themethods ofanalysis used
inthe nine Member States oftheEuropean Community . (Rapporteur
R.Mestres ).
2.AEuropean Community study onthedetermination oforganochlorine
pesticide residues infatty materials . (Rapporteur P.A.Greve ).
3. Pesticide residues inhuman fat and human milk inthe nine Member
States oftheEuropean Community (1969-1973 ). (Rapporteur G.L.
Gatti ).
4.Preparatory study forestablishing criteria (Dose /Effect relations -
ships )forhumans onorganochlorine compounds i.e. pesticides and
their metabolites , (Rapporteur M.Mercier ).
5.European Colloquium entitled "Problems raised bythe contamination
ofman and his environment bypersistent pesticides and organohalo -
genated compounds ",held on14-16May 1974 . (EUR 5196 ).
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