ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(78)664
Vol.1978/0254

Disclaimer
Conformément aurèglement(CEE,Euratom)n°354/83duConseildu1erfévrier1983
concernantl'ouvertureaupublicdesarchiveshistoriquesdelaCommunauté économique
européenneetdelaCommunautéeuropéennedel'énergieatomique(JOL43du15.2.1983,
p.1),telquemodifiéparlerèglement(CE,Euratom)n°1700/2003du22septembre2003
(JOL243du27.9.2003,p.1),cedossierestouvertaupublic.Lecaséchéant,lesdocuments
classifiésprésentsdanscedossierontétédéclassifiésconformément àl'article5dudit
règlement.
InaccordancewithCouncilRegulation(EEC,Euratom)No354/83of1February1983
concerningtheopeningtothepublicofthehistoricalarchivesoftheEuropeanEconomic
CommunityandtheEuropeanAtomicEnergyCommunity(OJL43,15.2.1983,p.1),as
amendedbyRegulation(EC,Euratom)No1700/2003of22September2003(OJL243,
27.9.2003,p.1),thisfileisopentothepublic.Wherenecessary,classifieddocumentsinthis
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),istdieseDateiderÖffentlichkeitzugänglich.Soweit
erforderlich,wurdendieVerschlusssachen indieserDateiinÜbereinstimmung mitArtikel5
dergenanntenVerordnungfreigegeben.

COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(78 )664final
Brussels.4December1978
■ .• •.-/s\
'-K^-'./Xi ,'T ■A
■- ..vr>
^■ *.^
•i;sJ
PROPOSALFORACOUNCILDIRECTIVE
establishing safetymeasuresagainsttheconjecturalrisks
risksassociated withrecombinant USAwork
(submittedtotheCouncilbytheCommission)
COM(78 )664final

PROPOSALFORACOUNCILDIRECTIVE
establishingsafetymeasuresagainsttheconjectural
risksassociatedwithrecombinant UNAwork
Theaimsofthispreamblearetointroducetheessentialfeaturesofrecombi­
nantDMAworkinthegeneralbackgroundofmoderndevelopments inbiotechnolo­
gyandtopresenttheconsiderations whichhaveledtheCommissiontoprepare
theprojectofadirectivecompellingtheMemberStatestoadoptgeneralpre­
cautionsagainsthazardspossiblyassociatedtocertainformsofrecombinant
DNAwork.
Recombinant PITAworkanditsimportanceforResearchandDevelopment
Moderntechniquesandmostparticularly theuseofrecentlydiscoveredenzymes,
calledrestriction enzymes,nowallowthearrangement ofgeneticmaterialin
combinations whichatthemomentdonotexistundernaturalconditions.The
generalmethodinvolvestheisolationofSNAfromadonororganism,itsfrag­
mentationbyrestriction enzymesintogroupsofoneormoregenes,thecoupling
ofselectedfragmentstoavector(usuallyavirusoraconstituentofthe
celltobeusedashost)anditsintroductioninahost-cellwhichmay
bepropagatedtoformpopulationsofidenticalcellscalledclones.
Providedthatthegeneticmaterialtransferredinthismannerreplicatesand
expressesitselfinitsnewsurroundings ,therearetheoretically nolimits
totherangeoforganismswithnewpropertieswhichmaybeproducedthrough
theuseofrecombinant DNAtechnology.Inpractice,however,thecloningand
expressionofforeignD1TAintowidelyunrelatedhost–organismsareextremely
difficulttoachieveand,insomecases,probablyimpossible.Yet,DJTAsequences
codingforhumanplacentallactogenandhumangrowthhormonehavebeencloned
inthebacteriaEscherichiacoli(anaturalresidentofthehumandigestive
tract)andinatleasttwoinstances(expressioninE.coliofachemically
nynthotizedgeneforthehormonesomatostatin andoftheyeaststructural

genefortheenzymeimidazole-glycerophosphate dehydratase)hasit"beenshown
thattheexpressionproblemcould "beovercome.
Itisobvious,inviewoftheseprospectsandoftheseresults,thatrecombi­
nantDNAtechnologyopensupnewavenuesforfundamental andappliedwork
whichwillcertainlyleadtoanenormousimprovementinourknowledgeof
geneticstructuresandgeneticfunctionsandwhich,inthelongrun,could
completelyrevolutionize certainproductionmethodsinagriculture andindus­
try.Whilegrowthhormoneandinsulinrepresentwellknowexamplesofproducts
whichcouldbeelaboratedatindustriallevelbymanipulatedbacteria,several
othersubstances(calcitonin,prolactin,neurotransmitters ,antibodies•••)
mayalsobeproducedinthesamemannerbythepharmaceutical industries.In
themedicalsciences,onemayconceivethattherepairingofgenetiodefects
inmanwillonedaybecomefeasible^withthehelpofrecombinant DfTAwork.
Inagriculture ,throughappropriategenetictransfersinisolatedprotoplasts
regeneratedafterwardsintoentireplants,modifiedcropspeciescouldbe
obtainedwhichwouldcombinethecharacteristics ofunrelatedspeciesand
presentnovelpropertieswithregardtonitrogenuptake,diseaseresistance
andawiderangeofdifferentqualityfactors.Suchprogressesarenotyet
insightbutarewithinourreachaslongtermobjectives.Countrieswith
moderntechnologies ,suchastheUSAandJapan,havefullyrealizedtheimpor­
tanceofresearchinthisareaandinallrelatedfieldsofappliedmolecular
biology.
Rinksassociatedtorecombinant DMwork
Whileitisdifficulttopredictwhatacompetentmicrobiologist couldachieve
ifheundertooktoimprovesystematically ,throughgeneticmanipulations ,the
virulenceofimportantplantpathogensortoincorporateinE.colitheMA
fromhighlypathogenicorganismslikeBacillusanthracisorClostridium
botulinum,itappearsthat,exceptforsuchdeliberateattemptstoendanger
manandhisenvironment,theriskassociatedtorecombinant DNAworkisatthe
momentconjecturaland,toaverylargeextent,controllable.
-Conjecturalnatureoftheassociatedrisks
Thereis,intheory,ariskthatlivingorganisms,andparticularlymicro­
organismsresidinginmanorinspeciesimportanttoman,acquireupon
./

-3-
receiptofforeignINApropertieswhichrenderthemdangerousandharmfully
Asamatteroffact,anytransferofgeneticinformationwhichconferssimul­
taneouslytothehost-organism aselectiveadvantageandamodificationof
characterswilltosomeextentaffectourenvironment.Theeffectsmaybe
almostnegligibleorbeneficialifthenewcharactersarenearlyneutralor
usefultoman;theymaybedevastating,eitheratshortorlongterm,if
theypromotenewfactors(pathogenicity ,inductionorpropagationofcancers,
modificationofenvironmental equilibrium,ruptureoffoodchains...)which
manandthesurroundings hehasdomesticated areunabletotolerate.
Inpractice,however,thisriskhasnotyetbeenverified.Onthecontrary,
mostoftheexperimentsandmodelscenarios(seeforinstanceCURTISSR.
Ann.Rev.Microbiol.30:507-533»1976andreportoftheU.S.-EMBOWork­
shopheldinAscot,England,January27-29,1978)constructedforassessment
purposesdopointoutthatorganismsbearingrecombinant ENAareperhaps
unlikely,forvariousreasonsdealingwiththelowadaptivefitnessof
manipulatedcellsandthegeneralrequirements fortranscription andinfec­
tion,togeneratebiohazardsgreaterthanthoseassociatedtoconventional
researchwithpathogens.Inaddition,itmaybesuggestedfromthefact
thatthereproductive barriersandisolatingmechanismsoperatinginnature
areerror-prone andoverlappingthatthereisperhapsnosuchthing,under
naturalconditions,asanabsolutebarriertogeneexchangebetweenanytwo
organisms.Thencemanandhisenvironment ,sincetheysurvivedtheconti­
nuousflowofgeneticinformation betweenspecies,maypossiblybeconside­
redasrelativelytoleranttoanynewformofrecombinant MA.
-Possibilitiesforcontrol
Particularly becausethescientistsengagedinrecombinant DMAworkwere
thefirsttopointout(AsilomarConference,1973)thedangerspossibly
associatedtotheiractivities,researchinthisareahascontinuously been
connectedtothedevelopmentofcontainmentdevicesandofmonitoring
systems.Asaresultofthis,methods,crippledhoststrainsandfacilities
havebeencreatedwhichgreatlyreducethechancethatanorganismbearing
recombinant UNAescapesthelaboratory(physicalcontainment)orsurvives
toconditionsprevailingoutsidethelaboratory(biologicalcontainment).
./■

While theforms ofcontainment available ,andparticularly those pertaining
tobiological containment ,certainly need tobeimproved andsophisticated ,
they already provide ,when used correctly ,avery strong protection against
therisk that manandhisenvironment arecontaminated byrecombinant DNA .
Guidelines and national safety measures
Thedevelopment ofrecombinant DNAtechniques hascaused intense public and
scientific debate inmany countries which involved such issue asthedefini­
tion ofthe field covered byrecombinant DNAwork ,theclassification ofthis
work incategories ofrisks and inlevels ofcontainment ,thenecessity for
state control ,thetype ofcontrol (voluntary orstatutory )tobeinvolved
and theprotection ofintellectual property .
Inthe USA,theNational Institute ofHealth (NIH )released very detailed
guidelines providing anaccurate classification ofresearch activities in
categories ofrisks andofassigned containment levels .Atthemoment only
thelaboratories sponsored bytheNIHarecompelled tofollow these guidelines
which arepresently under revision andwill probably bemade less stringent .
Guidelines somewhat similar tothose oftheNIHhave been prepared orare in
preparation ,outside theCommunity ,inallcountries with advanced technolo­
gies but,asyet,nocompulsory order have been issued onthematter inthese
countries .
Within theEuropean Community ,theUnited Kingdom hasrendered compulsory
advance notification ofgenetic manipulation work byallthose whointend to
carry outsuch work onthenational territory .Acode ofpractice ,which
differs from that oftheNIHonessential points dealing with classification
procedures andcontainment methods ,isatthemoment operated under avolun­
tary basis butwith theunderstanding that theinspectors oftheHealth and
Safety executive have extensive powers toenforce duties aswell aspre­
cautions recommended bytheBritish Advisory Group .Theother Member
States have also prepared oradopted guidelines toresearch with recombinant
DNAwhich insome cases adhere toeither theBritish ortheAmerican system
andinothers represent acompromise between thetwosets ofguidelines .

-5-
InFrance ,TheNetherlands ,Denmark and .Belgium ,theNational Advisory
Committees have "been assigned thetask toregister thework athand andtoreview
research proposals .While adeclaration ofagreement has "been drafted in
Prance under which governmental ,academic andindustrial laboratories
will submit toreview andapproval anyproject forrecombinant DNAwork ,only
twoMember States (TheFederal Republic ofGermany andTheNetherlands )
have ,inaddition totheUnited Kingdom ,clearly indicated anintention
tointroduce regulations onrecombinant DNAresearch# IntheFederal
Republic ofGermany ,thecompulsory orders will first berestricted to
research financed bynational funds ;atalater stage ,they will beextended
toactivities supported bythe "Lender "andbyprivate Bources .
The elaboration oradoption ofguidelines intheMember States and inother
European countries hasbeen greatly facilitated bythe critical reviews and
recommendations which were issued bythead-hoo committee onrecombinant DNA
research oftheEuropean Science Foundation andbytheStanding Committee
ofE.M.B«0 »onrecombinant DNA#
Necessity fornational legislations based onCommunity standards
Itistheview oftheCommission that six different sets ofconsiderations
strongly underline thenecessity fornational laws onthematter :
-Harmony between Member States
Although itisnotdesirable ,inview ofthedifferences between thevarious
containment facilities available inEurope ,that identical guidelines are
adopted andfollowed byallMember States ,itisnevertheless essential ,
toavoid large variations inresearch potentialities ,that certain basic
/

principlesofsafetyareacceptedandadheredtobytheCommunityof
MemberStates.ThepresentsituationinwhichsomeMemberStateshave
adoptedlegislation onrecombinant DNAworkorareplanningtodosowhile
othershaven'tasyetdefinedanyformalpolicyonthematteris,inthis
respect,unacceptable totheeyesoftheCommissionbecauseitwillleadto
thedevelopmentofdifferingconditionsofsafety,workandsuccessbetween
MemberStatesand,subsequently ,totheconcentration ofresearchactivities
atthemostpermissivesites.Suchanexpansionofdivergenceswillnot
ariseifnationallegislations ,harmonizedinpartaroundacoreofCommunity
principles,areadoptedineachMemberStateandprovidethenecessarytools
forthepermanentimplementation ofsafetymeasurescomparableinessence
throughouttheentireCommunity.
Theexemplaryvalueoflegislation onrecombinant IfPTAtechnology
Geneticmanipulations onlyformasmallpartoftheattemptswhichmanis
nowmakingforassumingtheresponsibility forlifeonthisplanetandfor
transforming hisapproachtothedomestication oflowerforms.Severalnew
methodshavenowbeendevelopedwhichallowtheimmobilization oncarriers,
forindustrialuse,ofenzymesandofcells,theproductionofnewsynthetic
compounds,themass-production ofproteinsinfermentation batchesand,in
ageneralmanner,acompletemodification oftherelationship betweenman
andnature.Inthelongterm,theapplications ofmolecularbiologyto
agriculture andindustrywillunavoidablytransformlifeinsocietyandwill
inducesignificant and,possibly,irreversible changestoourenvironment.
Torequestthatthetechniqueswhicharetobringthesechangesaresubjec­
ted,fromthestart,tostatutorycontrolandtolegislation doesnotcons­
tituteanaggressiontoprogressbut,onthecontrary,arecognitionofthe
needtoadaptsocietytonewscientificdevelopments.
Recombinant DNAwork,eventhoughtheriskitrepresentsisconjectural,
wellanalysedintheMemberStatesandpossiblynotgreaterthanthedangers
associatedtoconventionalresearchwithpathogens,constitutes,inthis
connexion,achoicematerialforestablishingcompatibilities betweenlegis­
lationandthedevelopmentofmoderntechnologies andforpreparingafirst
basistothedispositions whichwillundoubtedlyhavetobetakeninthe
futuretoprotectmanagainsthisownachievements.Providedthatthe
legislationadoptedistolerant,flexible,andassociatedtoa,stimulation
ofresearchthroughfunding,theopportunityshouldnotbemissed.
•/

I_T-
-Gravity ofthehazards
Theclassification ofarisk asconjectural does notimply that therisk
under consideration isbenign .While scenarios representing theplanet
colonized byanewclass oforganisms combining therequirements and
features ofbacteria andmammals areofcourse purely fictitious theexpansion
ofmyxomatosis inEurope orthedestruction ofatobacco field byblack
shank illustrate thegravity ofthedangers which maybeassociated tothe
sudden spread ofmicroorganisms with properties adapted totheir environ­
ment .Itis,asamatter offact ,inprevision ofsuch conjectural dangers
that various forms ofphysical containment andcertified strains ofbacteria
unable tosuryive outside laboratory conditions arebeing produced through­
outtheWestern world .Ifthegravity oftherisk involved issuch asto
require theelaboration ofthese expensive protection devices itcertainly
justifies thepreparation oforders intended toinsure that they effecti­
vely serve their purpose andareused toprotect against therisk which
they aresupposed tocontain .
-Exoansion ofrecombinant MA work
Scientific progress inthefield isoccuring sorapidly that anumber of
experiments involving theproduction anduseofrecombinant UNAcannowbe
executed onaroutine basis andconstitute classical approaches tocertain
investigations inmolecular genetics »What appeared tobe,afewyears
ago ,avery sophisticated technique accessible toasmall number ofhighly
specialized institutes isbeing commonly used ,inmany laboratories ,for
specifying genes andtheir products 0Inaddition ,several centers devoted
toapplied research ,andamong than many laboratories operated byprivate
industriesj have "bocorae aware ofthepotentialities ofrecombinant DNA
techniques forgenetic engineering purposes andhave launched ,orare
contemplating tolaunch ,important research actions centred upon theproduc­
tion anduseofrecombinant M® Thus therisk ,ifthere isone ,which is
associated torecoiabinsni MAisincreasing with time inproportion with
thetotal number ofeites where such work iscarried out.

-8-
-Transnational nature ofthe risk
The fact that thebiological material subjected torecom"binant DNAwork
usually includes viruses andbacteria which ,assuming their escape from
thelaboratory ,arenotsubjected tothebarrier ofnational borders reduces
toacertain extent the liberty ofindividual nations todefine andtofollow
independent policies inthefield ofgenetic manipulations# Agreement must
bereached within communities ofneighbouring countries onthe general
objectives andscale oftheprotection systems which aretobeestablished
andguarantees must begiven totherespect ofthese agreements® Such
^agreements andsuch guarantees canbest begenerated through legal disposi­
tions ,taken ineach country ,which arebased upon acore ofprinciples
adopted incommon *
-Research inlaboratories from private enterprises
While itispossible toconceive ,intheabsence ofnational legislations
regulating work with recombinant DNA ,that thegovernmental funding agencies
maintain acertain level ofcontrol over the research activities ofuniver­
sities andnational institutes ,itisfarmore difficult toenvisage ,inthe
absence oflegal dispositions ,asystem compelling thelaboratories from
private industries toadhere totheterms ofnational guidelines onrecombi­
nantMA»There is,inother words ,inacountry where such guidelines are
followed onavoluntary basis ,arisk that different laboratories working
atidentical levels ofrisks donotobserve thesame rules tosafeguards
andtocontainment® Whereas itisobvious that asituation ofthis type is
unacceptable itisalso equally obvious ,inview oftheimportance of
recombinant MAtechnology forthepromotion ofEuropean bio-industries ,
that alegislation onrecombinant UTAwork must notendanger intellectual
property rights andthat special attempts will have tobemade bythe
legislator torestrict toaminimum thedisclosure byindustries ofconfi­
dential scientific information#
./■

9
-9~
ACommunity directive onrecombinant DNAwork
Theproblems raised bygenetic manipulations andthepossible need fora
Community directive compelling each Member State toadopt certain measures
ofprotection andofcontrol against conjectural risks have been discussed
several times bytheCommittee onMedical andPublic Health Research (C.R.M. )
andbyadhocexpert groups inthepresence ofrepresentatives ofE„S.F.
and EMBO .
Following this period ofconsultation ,theCommission prepared theattached
project for aCouncil directive regulating work onrecombinant DNA .This
project takes simultaneously into account thenecessary requirements for
safety andtheneed forflexibility andadaptation tolocal circumstances .
While stipulating that recombinant DNAconsidered tobeassociated tocon­
jectural hazards cannot beperformed ifitisnotfirst registered andautho­
rized bytheNational Authority ,theproposed directive leaves entire liber­
tytothis National Authority ineach Member State toestablish thecatego­
rization andcontainment levels which itdeems most appropriate .Special
provision istaken forwork tabulated aslowrisk andattempts aremade to
reduce ataminimum the amount ofscientific information which istobe
disclosed forregistration andauthorization purposes .Finally ,full refe­
rence ismade inthe text ofthedirective tothe fact that theterms ofthe
present orders will have tobereviewed regularly atshort intervals and
revised ,when necessary ,atthelight ofnewdevelopments andscientific
progresses .Inaddition ,theCommission will study "thespecial case ,
covered atthentoment bytheterms ofthepraeent directive ,which oonoems
theus®ofrecoHihinajit 32$Amatex-ial forlarge soale industrial production ;
ifneoeseary additional directives adapted tosuoh caa©will beproposed
bythaCommission®
* #

Original EngLish
CONJECTURAL HAZARDS OFRECOMBINANT DNAWORK
CouncilDirective
TheCounciloftheEuropeanCommunities,
HavingregardtotheTreatyestablishing theEuropeanEconomicCommunity,and
inparticularArticle235thereof,
HavingregardtotheproposalfromtheCommission , ,
HavingregardtotheopinionoftheEuropeanParliament,
WhereasArticle2oftheTreatyassignstotheCommission thetask,among
others,topromotethroughout theCommunity aharmonious development ofecono­
micactivities,acontinuous andbalancedexpansion andanincreaseinstabi­
lity;
Whereasthedevelopment ofbasicandappliedbiological researchisofakind
tocontributewithefficiency towardstheachievement oftheseobjectives ;
Whereasthisdevelopment implies,inseveralsectors,thatrecombinant DNA
workbeperformedoncertainorganisms;
Whereasrecombinant DNAworkperformedoncertainorganims,andparticularly
onmicroorganisms residentinman,orincertainanimalandplantspeciesused
inagriculture,maypresentconjectural hazardstoman,tohisfoodresources
andtohisenvironment ingeneral;

Whereas measures ofprotection settled "by "theauthorities against
such conjectural hazards must becombined with thedevelopment ofrecombinant
DNAwork ;
Whereas this development involves epidemiological andhence international
conjectural hazards ;
Whereas thedisparities "between theprovisions inforce orinprepa­
ration inthedifferent Member States forestablishing measures ofprotection
against theconjectural hazards ofrecombinant MAwork maygive rise to
differing conditions ofsafety ,work andsuccess affecting directly the
scientific andtechnological competitiveness ofthe laboratories concerned in
thoMember States ?
Whereas action bytheCommunity inthematter istnerefore
necessary totherealization oftheobjectives oftheTreaty ;
'whereas itisnecessary totake into account thecomplexity oftheproblem
posed bytheconjectural hazards ofcertain types ofrecombinant DNAwork ,
therapid evolution intheunderstanding ofthis problem ,theextent ofthe
research sector concerned andthe importance that must beattached tothe con­
sideration oflocal circumstances when assessing thehazards involved inpei–
forming scientific work ;
Whereas protocols areprepared forexperiments inrecombinant DNA work and it
isnecessary tominimize thedissemination ofthesubstance ofthose protocols
andresearch projects based ontheproduction anduseofrecombinant DNA in
order tosafeguard scientific andindustrial secrecy andtoprotect intellec­
tual property ;
Whereas theTreaty hasnotprovided thenecessary powers forthis purpose ;
HAS ADOPTED THIS DIRECTIVE :
Article 1
1.1This directive concerns theconjectural hazards associated with recombinant
DNA work .
/•

Forthepurpose ofthis directive ,thefollowing terms have themeaning
hereby assigned tothem :
a)Recombinant DNAwork :theformation ofnewcombinations ofheritable
material bytheinsertion ofnucleic acid molecules produced ,bywhatever
means ,outside thecell ,into anyvirus ,bacterial plasmid orother
vector system soastoallow their incorporation into ahost organism in
which they donotnaturally occur butinwhich they arecapable ofcon­
tinued propagation .
b)Recombinant DNAmaterials :theproduct ofrecombinant DNAwork consis­
ting oforganisms ,including viruses andviroids ,containing recombinant
DNAmolecules .
c)Laboratory :thesite where oneormore persons areengaged orplanning
tobecome engaged inrecombinant DNAwork and/orwhere oneormore per­
sons have introduced orareplanning tointroduce recombinant DNA
materials .
icle 2
Each Member State shall take appropriate steps toensure that noactivities
involving recombinant INAwork ortheacquisition anduse ofrecombinant
DNAmaterials maybeperformed onitsterritory without prior notification
totheappropriate national authorities and ,except foractivities falling
incategories oflowrisk ,without prior authorization from these authori­
ties .
Tothis effect ,each Member State shall subdivide inclasses ,according to
their nature andtheconjectural hazards that they involve ,thevarious
types ofrecombinant MA work .
This distribution inclasses shall bebased upon the
source anddegree ofpurity oftheDNAmolecule ,thevector-host system
utilized andthemanipulative procedures proposed .Theclasses ofrecom­
binant DNAwork thus established shall then begrouped into categories
defined onthebasis oftheparticular safety andsupervisory measures
that must beadopted inorder toprevent manorhisenvironment from
incurring anyhazard that theMember State maydeea excessive .Thesafety
andsupervisory measures assigned tothevarious classes ofrecombinant
ERAwork shall include theimplementation ofsound laboratory practice
/•

-4-
(ifnecessary through proper training ofsafety officers ,researenworKers
andtechnicians )andtheuseofphysical ana .biological means ofcontain­
ment .
3Notification oftheintention toundertake recombinant SITAwork orto
acquire recombinant USAmaterials shall belodged bytherequesting labo­
ratory with thenational authority# Thenotification shall beaccompanied
by :
-theportion oftheexperimental protocol which isrequired forthe
evaluation ofsafety atthesite where theproposed activities areto
becarried outand ,inthecase oftheacquisition ofrecombinant DUA
materials ,bythedescription ofthese materials andofshipping condi­
tions ;
-thelist oftheprotective andsupervisory measures tobeapplied
throughout theduration oftheexperimental work andduring storage ,
propagation andhandling ofrecombinant UNAmaterials ;
-thedescription ofthe general education inrecombinant RIA research and
ofthetraining received bythemembers ofthestaff whowill participate
totheproposed activities orwill beresponsible forsupervision ,moni­
toring orsafety .
4Thenational authority shall assess orhave assessed ,according tothe
criteria itdeems most suitable ,theconjectural hazards associated tothe
proposed activities .Itmayrequire from theapplicant
further information fortheevaluation ofconjectural risks andsafety
conditions and ,wherever such investigation seems necessary ,itshall
make adetailed on-site examination oftheconditions ofprotection and
safeguards .
Article
1Onthebasis oftheinformation available ,thenational authority shall
take oneofthefollowing decisions :
–toauthorize theproposed activities under theconditions described by
theapplicant :

-toauthorize theproposed activities oncertain conditions ;
-toprohibit theproposed activities .
2Thedecision ofthenational authority shall benotified inwriting to
thelaboratory concerned within aperiod notexceeding ninety days from
thedate ofreceipt oftheoriginal application forauthorization .
3Thenational authority shall ensure ,bythemethods ,itdeems most effec­
tive andappropriate ,that only theactivities that ithasauthorized are
carried outonthenational territory .Thenational authority shall ensure
that theprotective andsupervisory measures referred toinArticle2(3),
second indent ,andtheconditions referred toinArticle 3(l),second indent ,
arestrictly adhered to.Member States shall provide forappropriate
sanctions against anybreach ofthese rules .
4Thenational authority hasthepower torevoke anyauthorization ithas
given .
5IftheMember State amends thedefinition ofany ofthecategories of
recombinant DNAwork requiring special safety measures ,orifthese
measures areamended ,thenational authority shall ensure that anynew
requirement shall beimmediately fulfilled bythe laboratories inposses­
sion ofrecombinant DNAmaterials orperforming recombinant DNAwork on
thenational territory .Thenational authority shall revoke anyauthori­
zation which does not comply with thenewrequirement and,inthis case ,
shall order thesuspension ofactivities inhand ;resumption ofthese
activities shall beconditional upon the issue ofanewauthorization which
maybeestablished only after examination oftheprotective and supervi­
sory measures adopted bythe laboratory concerned .
Article 4
1Member States shall bring into force theprovisions needed inorder to
comply with this directive within oneyear ofitsnotification .They
shall forthwith inform theCommission oftheEuropean Communities thereof .

2MemberStatesshallensurethatthetextofthemeasureswhichtheyadopt
inthefieldcoveredbythisDirectiveiscommunicated totheCommission.
EachtextshallbepublishedbytheCommission.
3MemberStatesshalltransmittotheCommissionthedetailsofthe
categorization systemwhichtheyhaveadoptedandshallimmediately
informtheCommissionofanymodification madetothissystem.The
Commissionwillpublishthedetailsofthesecategorization systemsas
wellasanyamendmentmadetothembyMemberStates.
4MemberStatesshallsubmittotheCommission,attheendofeach
calendaryear,thelistofauthorizations deliveredduringtheyearand
ageneralreportoftheirexperienceandproblemsencounteredwiththe
regulationofrecombinant UNAwork.
Article5
1Becauseoftheunceasingprogressofknowledgeandtechniquesinthe
fieldofbasicandappliedbiology,thisDirectiveanditscontinued
applicability toproductionactivitiesofindustriesshallbethroughly
reviewed,andrevisedifnecessary,atregularintervalsnotexceeding
twoyears.
Article6
1ThisDirectiveisaddressedtotheMemberStates.
Doneat
FortheCouncil
ThePresident