NoC217/32 OfficialJournaloftheEuropeanCommunities 24.8.92
ProposalforaCouncilDirectiveamendingDirective90/679/EEContheprotectionofworkersfrom
risksrelatedtoexposuretobiologicalagentsatwork
(92/C217/03)
COM(92)261final—SYN421
(SubmittedbytheCommissionon15July1992)
Whereasthefirstlistofbiologicalagentsshouldcontain
separateinformationontheabovementioned propertiesin
ordertoprovidebetterprotectionforworkers,
HASADOPTEDTHISDIRECTIVE :
Article1
Directive90/679/EECshallbeamendedasfollows:
AnnexIIIshallbesupplemented byafirstlistof
Groups2,3and4biologicalagentsasgivenintheAnnex
tothisDirective .THECOUNCILOFTHEEUROPEAN COMMUNITIES
HavingregardtotheTreatyestablishingtheEuropean
EconomicCommunity ,andinparticularArticle118a
thereof,
HavingregardtotheproposalfromtheCommission ,drawn
upafterconsultingtheAdvisoryCommitteeonSafety,
HygieneandHealthProtectionatWork,
IncooperationwiththeEuropeanParliament,
HavingregardtotheopinionoftheEconomicandSocial
Committee,
WhereasArticle18ofDirective90/679/EEConthe
protectionofworkersfromrisksrelatedtoexposureto
biologicalagentsatwork(!)statesthat,inaccordancewith
theprocedurelaiddowninArticle118aoftheTreaty,the
Councilmustadoptafirstlistofgroup2,group3and
group4biologicalagentsforAnnexIIItothatDirective;
Whereasthisfirstlistofbiologicalagentsmustbeclassified
onthebasisofthedefinitionsgiveninArticle2(d)points2,3
and4(groups2,3and4)oftheDirective;
Whereas,forcertainofthesebiologicalagents,itis
appropriatetokeeplistsofexposedworkersformorethan
10yearsaftertheirlastexposuretothesaidbiological
agents;
Whereasotherbiologicalagentsarelikelytocauseallergicor
toxicreactions;Article2
1.MemberStatesshallbringintoforcethelaws,
regulationsandadministrative provisionsnecessaryto
complywiththisDirectivenotlaterthan30April1994.They
shallforthwithinformtheCommissionthereof.
2.MemberStatesshallcommunicate totheCommission
theprovisionsofnationallawalreadyadoptedorwhichthey
adoptinthefieldgovernedbythisDirective.
3.SuchprovisionsadoptedbytheMemberStatesshall
containareferencetothisDirective,orshallbeaccompanied
bysuchareferenceuponofficialpublication .TheMember
Statesshalldecidehowsuchreferenceismade.
Article3
ThisDirectiveisaddresedtotheMemberStates.
(')OJNoL374,31.12.1990,p.1.

24.8.92 OfficialJournaloftheEuropeanCommunities NoC217/33
ANNEX
ANNEX111
Introductorynotes
1.InlinewiththescopeofDirective90/679/EEConlyagentswhichareknowntoinfecthumansaretobe
included.Whereappropriate ,indicatorsaregivenofthetoxicandallergenicpotentialoftheseagents.Animal
andplantpathogenswhichareknownnottoaffectmanareexcluded.Indrawingupthisfirstlistofclassified
biologicalagentsconsiderationhasnotbeengiventogenetically-modified microorganisms .
2.Thelistofclassifiedbiologicalagentsisbasedontheeffectoftheseagentsonhealthyworkers.Nospecific
accountistakenofparticulareffectsonthosewhosesusceptibilitymaybeaffectedforoneorotherreasons
suchaspre-existingdisease,medication,compromisedimmunity,pregnancyorbreastfeeding .Additionalrisk
tosuchworkersshouldbeconsideredaspartoftheriskassessmentrequiredbyCouncil
Directive90/679/EEC.Inindustrialprocesses,laboratoryworkorworkwithanimalsinvolvingactualor
potentialexposuretobiologicalagentsofGroups3or4,anytechnicalprecautionstakenmustconformto
Article16(c)ofCouncilDirective90/679/EEC.
3.BiologicalagentswhichhavenotbeenclassifiedforinclusioninGroup2to4inthelist,arethereforenot
implicitlyclassifiedinGroup1.Foragentswheretherearemorethanonespeciesknowntobepathogenicto
man,thelistofclassifiedbiologicalagentsmayincludethewholegenusofabiologicalagent,togetherwith
individualentriesforthosespecieswhichareknowntobethemostimportantintermsofhumaninfectivity,
allergyandtoxicityoraremorefrequentlyencountered .Whenawholegenusismentionedintheclassifiedlist
ofbiologicalagents,itisimplicitthatthespeciesandstrainsknowntobenon-pathogenic areexcluded.
4.Whereastrainisattenuatedorhaslostknownvirulencegenes,thenthecontainmentrequiredbythe
classificationofitsparentstrainneednotnecessarilyapply,subjecttoassessmentappropriateforriskinthe
workplace,(e.g.whensuchastrainistobeusedasaproductorpartofproductforprophylactic/therapeutic
purposes).
5.Thenomenclatureofclassifiedagentsusedtoestablishthislistreflectsandisinconformitywiththelatest
internationalagreementsonthetaxonomyandnomenclatureofagentsatthetimethelistwasprepared.
6.Thislistofclassifiedbiologicalagentsreflectsthestateofknowledgeatthetimethatitwasdevised.
7.Allviruseswhichhavealreadybeenisolatedinhumansandwhicharenotallocatedinagroupinthelistareto
beclassifiedinGroup2asaminimum(specificmeasuresfortheseagentshavetobetakenaccordingto
Directive90/679/EEC).
8.Theclassificationofparasitesandtheresultingrequirementsastocontainmentapplyonlytostagesinthelife
cycleoftheparasiteinwhichitisliabletobeinfectioustohumansattheworkplace.
9.Thislistalsogivesaspecialindicationincaseswherethebiologicalagentsarelikelytocausetoxicorallergic
reactions,wherepreventivevaccinationisavailable,orwhereitisadvisabletokeepalistofexposedworkers
formorethan10years.Theseindicationsareshownbythefollowingletters:
A:Possibleallergiceffects.
D:Listofworkersexposedtothisbiologicalagenttobekeptformorethan10yearsafterlastknown
exposure .
T:Toxinproduction .
V:Vaccinationrecommended .

NoC217/34 OfficialJournaloftheEuropeanCommunities 24.8.92
Biologicalagent Classification Notes
BACTERIA ANDSIMILAR
Actinomadura madurae 2
Actinomadura pelletieri 2
Actinomycesgerencseriae 2
Actinomycesisraelii 2
Actinomycespyogenes 2
Actinomycesspp.(*) 2
Arcanobacterium haemolyticum (corynebacterium haemolyticum ) 2
Bacillusanthracis 3
Bacteroidesfragilis 2
Bartonellabacilliformis 2I
Bordetellabronchiseptica 2
Bordetellaparapertussis 2
Bordetellapertussis 2
Borreliaburgdorferi 2
Borreliaduttonii 2
Borreliarecurrentis 2
Borreliaspp.(*) 2
Brucellaabortus 3
Brucellacanis 3
Brucellamelitensis 3
Brucellasuis 3
Campylobacter fetus 2
Campylobacter jejuni 2
Campylobacter spp.(*) 2
Cardiobacterium hominis 2
Chlamydiapneumoniae 2
Chlamydiatrachomatis 2
Chlamydiapsittaci(avianstrains) 3
Chlamydiapsittaci(otherstrains) 2
Clostridiumbotulinum 2 T
Clostridiumperfringens 2
Clostridiumtetani 2 T,V
Clostridiumspp.(*) 2
Corynebacterium diphtheriae 2 T,v
Corynebacterium minutissimum 2
Corynebacterium pseudotuberculosis 2
Corynebacterium spp.(*) 2
Coxiellaburnetii 3
Edwardsiella tarda 2
Ehrlichiasennetsu(Rickettsiasennetsu) 2
Ehrlichiaspp.(*) 2
(*)'spp.'referstootherspecieswhichareknownpathogensinhumans.

24.8.92 OfficialJournaloftheEuropeanCommunities NoC217/35
Biologicalagent Classification Notes
Eikenellacorrodens 2
Enterobacteraerogenes 2
Enterococcus spp.(*) 2
Erysipelothrix rhusiopathiae 2
Escherichiacoli 2
Flavobacterium meningosepticum 2
Fluoribacterbozemanae (Legionella) 2
Francisellatularensis(TypeA) 3
Francisellatularensis(TypeB) 2
Gardnerellavaginalis 2
Haemophilusactinomycetem comitans(Actinobacillus ) 2
Haemophilusducreyi 2
Haemophilus influenzae 2
Haemophilusspp.(*) 2
Helicobacterpylori 2
Klebsiellaoxytoca 2
Klebsiellapneumoniae 2
Klebsiellaspp.() 2
Legionellapneumophila 2
Legionellaspp.(*) 2
Leptospirainterrogans (allserovars) 2
Listeriamonocytogenes 2
Listeriaivanovii 2
Morganellamorganii 2
Mycobacterium africanum 3 V
Mycobacterium aviumintracellulare 2
Mycobacterium bovis(excludingBCGStrain) 3 v
Mycobacterium chelonae 2
Mycobacterium fortuitum 2
Mycobacterium kansasii 2
Mycobacterium leprae 3
Mycobacterium malmoense 2
Mycobacterium marinum 2
Mycobacterium microti 3
Mycobacterium paratuberculosis 2
Mycobacterium scrofulaceum 2
Mycobacterium simiae 2
Mycobacterium szulgai 2
Mycobacterium tuberculosis 3 v
Mycobacterium ulcerans 3
Mycobacterium xenopi 2
Mycoplasmapneumoniae 2
(*)'sop.'referstootherspecieswhichareknownpathogensinhumans.

NoC217/36 OfficialJournaloftheEuropeanCommunities 24.8.92
Biologicalagent Classification Notes
Neisseriagonorrhoeae 2
Neisseriameningitidis 2
Nocardiaasteroides 2
Nocardiabrasiliensis 2
Nocardiafarcinica 2
Nocardianova 2
Nocardiaotitidis-caviarum 2
Pasteurellamultocida 2
Pasteurellaspp.(*) 2
Plesiomonasshigelloides 2
Proteusmirabilis 2
Proteuspenneri 2
Proteusvulgaris 2
Providenciaalcalifaciens 2
Providenciarettgeri 2
Providenciaspp.(*) 2
Pseudomonasaeruginosa 2
Pseudomonas mallei 3
Pseudomonas pseudomallei 3
Rhodococcusequi 2
Rickettsiaakari 3
Rickettsiacanada 3
Rickettsiaconorii 3
Rickettsiamontana 3
Rickettsiatyphi(Mooseri) 3
Rickettsiaprowazekii 3
Rickettsiarickettsii 3
Rickettsiatsutsugamushi 3
Rochalimaeaquintana 2
Salmonellaarizonae 2
Salmonellaenteritidis 2
Salmonellatyphimurium 2
SalmonellaparatyphiA,B,C 3 V
Salmonellatyphi 3 V
Salmonella (otherSerovars) 2
Shigellaboydii 2
Shigelladysenteriae (Type1) 3 T
Shigellaflexneri 2
Shigellasonnet 2
Staphylococcus aureus 2
Streptobacillus moniliformis 2
Streptococcus pneumoniae 2
(*)'spp.'referstootherspecieswhichareknownpathogensinhumans.

24.8.92 OfficialJournaloftheEuropeanCommunities NoC217/37
Biologicalagent Classification Notes
Streptococcus pyogenes 2
Streptococcus spp.(*) 2
Treponemacarateum 2
Treponemapallidum 2
Treponemapertenue 2
Treponemaspp.(*) 2
Vibriocholerae(includingElTor) 2
Vibrioparahaemolyticus 2
Vibriospp.(*) 2
Yersiniaenterocolitica 2
Yersiniapestis 3
Yersiniapseudotuberculosis 2
Yersiniaspp.(*') 2
VIRUSES(**)
Adenoviridae 2
Arenaviridae
JuninVirus 4
Lassafevervirus 4
Lymphocyticchoriomeningitis virus(neurotropicstrains) 3
Lymphocyticchoriomeningitis virus(otherstrains) 2
Machupovirus 4
MopeiavirusandotherTacaribeviruses 2
Astroviridae 2
Bunyaviridae
Bunyamwera viruses:
Bunyamwera virus 2
Oropouchevirus 3
Californiaencephalitisvirus 2
Hantaviruses :
Hantaan(Koreanhaemorrhagic fever) 3
Otherhantaviruses 3
Nairoviruses :
Congo/Crimeanhaemorrhagic fever 4
Hazaravirus 2
Phleboviruses :
RiftValleyfever 3 V
Sandflyfevervirus 2
Toscanavirus 2
OtherBunyaviridaeknowntobepathogenic 2
Caliciviridae 2
Coronaviridae 2
(*)4spp.'referstootherspecieswhichareknownpathogensinhumans.
(**)SeeIndroductoryNoteNo7.

NoC217/38 OfficialJournaloftheEuropeanCommunities 24.8.92
Biologicalagent Classification Notes
Filoviridae
Ebolavirus 4
Marburgvirus 4
Flaviviridae :
Australiaencephalitis (MurrayValleyencephalitis ) 3
CentralEuropeantick-borneencephalitisvirus 3
Absettarov 3 V
Hanzalova 3 V
Hypr 3 v
Kumlinge 3 v
Denguevirustypes1to4 3
HepatitisCvirus 3 D
JapaneseBencephalitis 3 V
KyasanurForest 3 v
Loupingill 3
Omsk 3 V(TBE)
Powassan 3
Rocio 3
Russianspring-summer encephalitis (TBE) 3 V
St.Louisencephalitis 3
Wesselsbron virus 3
WestNilevirus 3
Yellowfever 3 v
Otherknownflavivirusesknowntobepathogenic 2
Hepadnaviridae
HepatitisBvirus 3 V,D
HepatitisDvirus(Delta)C*) 3 V,D
Herpesviridae
Cytomegalovirus 2
Epstein-Barrvirus 2
Herpesvirussimiae(Bvirus) 3
Herpessimplexviruses1and2 2
Herpesvirusvaricella-zoster 2
HumanB-lymphotropic virus(HBLV-HHV6 ) 2
Orthomyxoviridae
InfluenzavirusestypesA,B,&C 2 V
Tick-borneOrthomyxoviridae : 2
Dhori&Thogotoviruses
Papovaviridae
BKandJCvirus 2 D(*)
Humanpapillomaviruses 2 D(*)
(*)Forworkinvolvingdirectcontactwiththeseagents.
(**)HepatitisDvirusisonlypathogenicinworkersinthepresenceofsimultaneousorsecundaryinfectioncausedbyHepatitisB
virus.

24.8.92 OfficialJournaloftheEuropeanCommunities NoC217/39
Biologicalagent Classification Notes
Paramyxoviridae ll
Measlesvirus 2 V
Mumpsvirus 2 V
Newcastlediseasevirus 2
Parainfluenza virusestypes1to4-2
Respiratorysyncytialvirus 2
Parvoviridae
Humanparvovirus(B19) 2
Picornaviridae
Acutehaemorrhagic conjunctivitisvirus(AHC) 2
Coxsackieviruses 2
Echoviruses 2
HepatitisAvirus(humanenterovirustype72) 2l
Polioviruses 2 V
Rhinoviruses 2
Poxviridae I
Buffalopoxvirus(') 2
Cowpoxvirus 2
Elephantpoxvirus(2) 2
Milkers'nodevirus 2
Molluscumcontagiosumvirus 2
Monkeypoxvirus 3 V
Orfvirus 2
Rabbitpoxvirus(3) 2
Vacciniavirus 2
Variola(major&minor)virus 4 V
Whitepoxvirus('variolavirus') 4
Yatapoxvirus(Tana&Yaba) 2
Reoviridae
Coltiviruses 2
Humanerotaviruses 2
Orbiviruses 2
Reoviruses 2
Retroviridae (*)
Humanimmunodeficiency viruses(AIDS) 3 D
HumanT-celllymphotropicviruses(HTLV)types1and2 3 D
Rhabdoviridae
Rabiesvirus 3 V
Vesicularstomatitisvirus 2
(')Twovirusesareidentified:oneabuffalopoxtypeandtheotheravariantofthevacciniavirus.
(2)Variantofcowpoxvirus.
(3)Variantof'vaccinia'.
(*)Atpresentthereisnoevidenceofinfectionofhumanswithretrovirusesofsimianorigin.Asaprecautioncontainmentlevel3is
recommended forworkwiththem.

NoC217/40 OfficialJournaloftheEuropeanCommunities 24.8.92
Biologicalagent Classification Notes
Togaviridae
Alphavirus :
Easternequineencephalomyelitis 3 V
Bebaruvirus 2
Chikungunya virus 2
Evergladevirus 2
Mayarovirus 3
Mucambovirus 3
Ndumuvirus 3
O'nyong-nyong virus 2
RossRivervirus 2
SemlikiForestvirus 2
Sindbisvirus 2
Tonatevirus 3
Venezuelanequineencephalomyelitis 3 V
Westernequineencephalomyelitis 3 V
Otherknownalphaviruses 2
Rubivirus (rubella) 2 v
Toroviridae 2
Unclassified viruses
Blood-bornehepatitisvirusesnotyetidentified 3 D
HepatitisEvirus 3
Norwalkvirus 2
Unconventional agentsassociatedwithi1):
Creutzfeld-Jakob disease 3 Dn
Gerstmann-Sträussler-Scheinker syndrome 3 D(*)
Kuru 3 Dn
PARASITES
Acanthamoeba castellani 2
Ancylostomaduodenale 2
Angiostrongylus cantonensis 2
Angiostrongylus costaricensis 2
Ascarislumbricoides 2 A
Ascarissuum 2 A
Babesiadivergens 2
Babesiamicroti 2
Balantidium coli 2
Brugiamalayi 2
Brugiapahangi 2
Capillariaphilippinensis 2
(1)Thereisnoevidenceinhumansofinfectionscausedbytheagentsresponsibleforbovinespongiformencephalitisand'scrapie'.
Nevertheless ,containmentlevel2isrecommended asaprecautionforworkinvolvingcontactwiththeseagentsorwithtissues
infectedbytheseagents.
(»)Forworkinvolvingdirectcontactwiththeseagents.

24.8.92 NoC217/41 OfficialJournaloftheEuropeanCommunities
Biologicalagents Classification Notes
Capillariaspp.(*) 2
Clonorchissinensis 2
Clonorchisviverrini 2
Cryptosporidium parvum 2
Cryptosporidium spp.(*) 2
Dipetalonema streptocerca 2
Diphyllobothrium latum 2
Dracunculus medinensis 2
Echinococcusgranulosus 3
Echinococcus multilocularis 3
Echinococcus vogeli 3
Entamoebahistolytica 2
Fasciolagigantica 2
Fasciolahepatica 2
Fasciolopsisbuski 2
Giardialamblia(Giardiaintestinalis) 2
Hymenolepisdiminuta 2
Hymenolepisnana 2
Leishmaniabrasiliensis 3
Leishmaniadonovani 3
Leishmaniaethiopica 2
Leishmaniamexicana 2
Leishmaniaperuviana 2
Leishmaniatropica 2
Leishmaniamajor 2
Leishmaniaspp.(*) 2
Loaloa 2
Mansonellaozzardi 2
Mansonellaperstans 2
Naegleriafowleri 3
Necatoramericanus 2
Onchocerca volvulus 2
Opisthorchisfelineus 2
Opisthorchisspp.(*) 2
Paragonimuswestermani 2
Plasmodiumfalciparum 3
Plasmodiumspp.(*)(human&simian) 2
Sarcocystissuihominis 2
Schistosoma haematobium 2
Schistosoma intercalatum 2
Schistosomajaponicum 2
Schistosoma mansoni 2
Schistosomamekongi 2
(*)4spp'referstootherspecieswhichareknownpathogensinhumans.

NoC217/42 OfficialJournaloftheEuropeanCommunities 24.8.92
Biologicalagents Classification Notes
Strongyloidesstercoralis 2
Strongyloides spp.(*) 2
Taeniasaginata 3
Taeniasolium 3
Toxocaracanis 2
Toxoplasmagondii 2
Trichinellaspiralis 2
Trichuristrichiura 2
Trypanosoma bruceibrucei 2
Trypanosoma bruceigambiense 3
Trypanosoma bruceirhodesiense 3
Trypanosoma cruzi 3
Wuchereriabancroftii 2
FUNGI
Aspergillusfumigatus 2 A
Blastomycesdermatitidis (Ajellomycesdermatidis) 3
Candidaalbicans .2 A
Coccidioides immitis 3 A
Cryptococcusneoformans (Filobasidellaneoformansvarneoformans
andF.neoformansvargarrii)2 A
Emmonsiaparvavumvar.parva 2
Emmonsiaparvavumvar.crescens 2
Epidermophyton floccosum 2 A
Fonsecaeacompacta 2
Fonsecaeapedrosoi 2
Histoplasmacapsulatumvarcapsulatum(Ajellomycescapsulata) 3
Histoplasmaduboisii 3
Madurellagrisea 2
Madurellamycetomatis 2
Microsporum spp.(*) 2 A
Neotestudina rosatii 2
Paracoccidioides brasiliensis 3
Pénicilliummarneffei 2 A
Sporothrixschenckii2
Trichophyton rubrum 2
Trichophyton spp.(*)2
(*)'sop.'referstootherspecieswhichareknownpathogensinhumans.