Commission Directive (EU) 2019/1833 of 24 October 2019 amending Annexes I, III, V and VI to Directive 2000/54/EC of the European Parliament and of the Council as regards purely technical adjustments
Modified by
  • Commission Directive (EU) 2020/739of 3 June 2020amending Annex III to Directive 2000/54/EC of the European Parliament and of the Council as regards the inclusion of SARS-CoV-2 in the list of biological agents known to infect humans and amending Commission Directive (EU) 2019/1833, 32020L0739, June 4, 2020
Commission Directive (EU) 2019/1833of 24 October 2019amending Annexes I, III, V and VI to Directive 2000/54/EC of the European Parliament and of the Council as regards purely technical adjustments
Article 1Annexes I, III, V and VI to Directive 2000/54/EC are replaced by the text in the Annex to this Directive.
Article 21.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20 November 2021 at the latest. However, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the amendments to Annexes V and VI to Directive 2000/54/EC, insofar as they relate to the biological agent SARS-CoV-2, by 24 November 2020 at the latest.They shall forthwith communicate to the Commission the text of the provisions referred to in the first subparagraph.When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 4This Directive is addressed to the Member States.
nullANNEX(1)Annex I to Directive 2000/54/EC is replaced by the following:"ANNEX IINDICATIVE LIST OF ACTIVITIES(Article 4(2))Preliminary noteWhere the result of the risk assessment, carried out in accordance with Article 3 and Article 4(2) of this Directive, shows an unintentional exposure to biological agents, there may be other work activities, not included in this Annex, which should be considered.1.Work in food production plants.2.Work in agriculture.3.Work activities where there is contact with animals and/or products of animal origin.4.Work in healthcare, including isolation and post-mortem units.5.Work in clinical, veterinary and diagnostic laboratories, excluding diagnostic microbiological laboratories.6.Work in refuse disposal plants.7.Work in sewage purification installations."(2)Annex III to Directive 2000/54/EC is replaced by the following:"ANNEX IIICOMMUNITY CLASSIFICATIONArticle 2, second paragraph, and Article 18INTRODUCTORY NOTES1.In line with the scope of the Directive, only agents which are known to infect humans are to be included in the classified list.Where appropriate, indicators are given of the toxic and allergic potential of these agents.Animal and plant pathogens which are known not to affect man are excluded.In drawing up this list of classified biological agents consideration has not been given to genetically modified micro-organisms.2.The list of classified agents is based on the effect of those agents on healthy workers.No specific account is taken of particular effects on those whose susceptibility may be affected for one or other reason such as pre-existing disease, medication, compromised immunity, pregnancy or breast feeding.Additional risk to such workers should be considered as part of the risk assessment required by the Directive.In certain industrial processes, certain laboratory work or certain work with animals involving actual or potential exposure to biological agents of groups 3 or 4, any technical precautions taken must comply with Article 16 of the Directive.3.Biological agents which have not been classified for inclusion in groups 2 to 4 of the list are not implicitly classified in group 1.For genera where more than one species is known to be pathogenic to man, the list will include those species which are known to be the most frequently responsible for diseases, together with a more general reference to the fact that other species of the same genus may affect health.When a whole genus is mentioned in the classified list of biological agents, it is implicit that the species and strains known to be non-pathogenic are excluded.4.Where a strain is attenuated or has lost known virulence genes, then the containment required by the classification of its parent strain need not necessarily apply, subject to assessment appropriate for risk in the workplace.This is the case, for example, when such a strain is to be used as a product or part of a product for prophylactic or therapeutic purposes.5.The nomenclature of classified agents used to establish this list reflects and is in conformity with the latest international agreements of the taxonomy and nomenclature of agents at the time the list was prepared.6.The list of classified biological agents reflects the state of knowledge at the time that it was devised.It will be updated as soon as it no longer reflects the latest state of knowledge.7.Member States are to ensure that all viruses which have already been isolated in humans and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.8.Certain biological agents classified in group 3 which are indicated in the appended list by two asterisks (**), may present a limited risk of infection for workers because they are not normally infectious by the airborne route.Member States shall assess the containment measures to be applied to such agents, taking account of the nature of specific activities in question and of the quantity of the agent involved, with a view to determining whether, in particular circumstances, some of these measures may be dispensed with.9.The requirements as to containment consequent on the classification of parasites apply only to stages in the life cycle of the parasite in which it is liable to be infectious to humans at the workplace.10.This list also gives a separate indication in cases where the biological agents are likely to cause allergic or toxic reactions, where an effective vaccine is available, or where it is advisable to keep a list of exposed workers for more than 10 years.These indications are shown by the following letters:A:Possible allergic effectsD:List of workers exposed to this biological agent to be kept for more than 10 years after the end of last known exposureT:Toxin productionV:Effective vaccine available and registered within the EUThe application of preventive vaccination should take account of the code of practice given in Annex VII.BACTERIAand similar organismsNB: For biological agents appearing on this list, the entry of the whole genus with the addition of "spp." refers to other species belonging to this genus that have not specifically been included in the list, but which are known pathogens in humans. See introductory note 3 for further details.
See paragraph 8 of the introductory notes.
Biological agentClassificationNotes
Actinomadura maduraeW
Actinomadura pelletieri2
Actinomyces gerencseriae2
Actinomyces israelii2
Actinomyces spp.2
Aggregatibacter actinomycetemcomitans (Actinobacillus actinomycetemcomitans)2
Anaplasma spp.2
Arcanobacterium haemolyticum (Corynebacterium haenolyticum)2
Arcobacter butzleri2
Bacillus anthracis3T
Bacteroides fragilis2
Bacteroides spp.2
Bartonella bacilliformis2
Bartonella quintana (Rochalimaea quintana)2
Bartonella (Rochalimaea) spp.2
Bordetella bronchiseptica2
Bordetella parapertussis2
Bordetella pertussis2T, V
Bordetella spp.2
Borrelia burgdorferi2
Borrelia duttonii2
Borrelia recurrentis2
Borrelia spp.2
Brachyspira spp.2
Brucella abortus3
Brucella canis3
Brucella inopinata3
Brucella melitensis3
Brucella suis3
Burkholderia cepacia2
Burkholderia mallei (Pseudomonas mallei)3
Burkholderia pseudomallei (Pseudomonas pseudomallei)3D
Campylobacter fetus subsp. fetus2
Campylobacter fetus subsp. venerealis2
Campylobacter jejuni subsp. doylei2
Campylobacter jejuni subsp. jejuni2
Campylobacter spp.2
Cardiobacterium hominis2
Cardiobacterium valvarum2
Chlamydia abortus (Chlamydophila abortus)2
Chlamydia caviae (Chlamydophila caviae)2
Chlamydia felis (Chlamydophila felis)2
Chlamydia pneumoniae (Chlamydophila pneumoniae)2
Chlamydia psittaci (Chlamydophila psittaci) (avian strains)3
Chlamydia psittaci (Chlamydophila psittaci) (other strains)2
Chlamydia trachomatis (Chlamydophila trachomatis)2
Clostridium botulinum2T
Clostridium difficile2T
Clostridium perfringens2T
Clostridium tetani2T, V
Clostridium spp.2
Corynebacterium diphtheriae2T, V
Corynebacterium minutissimum2
Corynebacterium pseudotuberculosis2T
Corynebacterium ulcerans2T
Corynebacterium spp.2
Coxiella burnetii3
Edwardsiella tarda2
Ehrlichia spp.2
Eikenella corrodens2
Elizabethkingia meningoseptica (Flavobacterium meningosepticum)2
Enterobacter aerogenes (Klebsiella mobilis)2
Enterobacter cloacae subsp. cloacae (Enterobacter cloacae)2
Enterobacter spp.2
Enterococcus spp.2
Erysipelothrix rhusiopathiae2
Escherichia coli (with the exception of non-pathogenic strains)2
Escherichia coli, verocytotoxigenic strains (e.g. O157:H7 or O103)3T
Fluoribacter bozemanae (Legionella)2
Francisella hispaniensis2
Francisella tularensis subsp. holarctica2
Francisella tularensis subsp. mediasiatica2
Francisella tularensis subsp. novicida2
Francisella tularensis subsp. tularensis3
Fusobacterium necrophorum subsp. funduliforme2
Fusobacterium necrophorum subsp. necrophorum2
Gardnerella vaginalis2
Haemophilus ducreyi2
Haemophilus influenzae2V
Haemophilus spp.2
Helicobacter pylori2
Helicobacter spp.2
Klebsiella oxytoca2
Klebsiella pneumoniae subsp. ozaenae2
Klebsiella pneumoniae subsp. pneumoniae2
Klebsiella pneumoniae subsp. rhinoscleromatis2
Klebsiella spp.2
Legionella pneumophila subsp. fraseri2
Legionella pneumophila subsp. pascullei2
Legionella pneumophila subsp. pneumophila2
Legionella spp.2
Leptospira interrogans (all serovars)2
Leptospira interrogans spp.2
Listeria monocytogenes2
Listeria ivanovii subsp. ivanovii2
Listeria invanovii subsp. londoniensis2
Morganella morganii subsp. morganii (Proteus morganii)2
Morganella morganii subsp. sibonii2
Mycobacterium abscessus subsp. abscessus2
Mycobacterium africanum3V
Mycobacterium avium subsp. avium (Mycobacterium avium)2
Mycobacterium avium subsp. paratuberculosis (Mycobacterium paratuberculosis)2
Mycobacterium avium subsp. silvaticum2
Mycobacterium bovis3V
Mycobacterium caprae (Mycobacterium tuberculosis subsp. caprae)3
Mycobacterium chelonae2
Mycobacterium chimaera2
Mycobacterium fortuitum2
Mycobacterium intracellulare2
Mycobacterium kansasii2
Mycobacterium leprae3
Mycobacterium malmoense2
Mycobacterium marinum2
Mycobacterium microti3
Mycobacterium pinnipedii3
Mycobacterium scrofulaceum2
Mycobacterium simiae2
Mycobacterium szulgai2
Mycobacterium tuberculosis3V
Mycobacterium ulcerans3
Mycobacterium xenopi2
Mycoplasma hominis2
Mycoplasma pneumoniae2
Mycoplasma spp.2
Neisseria gonorrhoeae2
Neisseria meningitidis2V
Neorickettsia sennetsu (Rickettsia sennetsu, Ehrlichia sennetsu)2
Nocardia asteroides2
Nocardia brasiliensis2
Nocardia farcinica2
Nocardia nova2
Nocardia otitidiscaviarum2
Nocardia spp.2
Orientia tsutsugamushi (Rickettsia tsutsugamushi)3
Pasteurella multocida subsp. gallicida (Pasteurella gallicida)2
Pasteurella multocida subsp. multocida2
Pasteurella multocida subsp. septica2
Pasteurella spp.2
Peptostreptococcus anaerobius2
Plesiomonas shigelloides2
Porphyromonas spp.2
Prevotella spp.2
Proteus mirabilis2
Proteus penneri2
Proteus vulgaris2
Providencia alcalifaciens (Proteus inconstans)2
Providencia rettgeri (Proteus rettgeri)2
Providencia spp.2
Pseudomonas aeruginosa2T
Rhodococcus hoagii (Corynebacterium equii)2
Rickettsia africae3
Rickettsia akari3
Rickettsia australis3
Rickettsia canadensis2
Rickettsia conorii3
Rickettsia heilongjiangensis3
Rickettsia japonica3
Rickettsia montanensis2
Rickettsia typhi3
Rickettsia prowazekii3
Rickettsia rickettsii3
Rickettsia sibirica3
Rickettsia spp.2
Salmonella enterica (choleraesuis) subsp. arizonae2
Salmonella Enteritidis2
Salmonella Paratyphi A, B, C2V
Salmonella Typhi3V
Salmonella Typhimurium2
Salmonella (other serovars)2
Shigella boydii2
Shigella dysenteriae (Type 1)3T
Shigella dysenteriae, other than Type 12
Shigella flexneri2
Shigella sonnei2
Staphylococcus aureus2T
Streptobacillus moniliformis2
Streptococcus agalactiae2
Streptococcus dysgalactiae subsp. equisimilis2
Streptococcus pneumoniae2T, V
Streptococcus pyogenes2T
Streptococcus suis2
Streptococcus spp.2
Treponema carateum2
Treponema pallidum2
Treponema pertenue2
Treponema spp.2
Trueperella pyogenes2
Ureaplasma parvum2
Ureaplasma urealyticum2
Vibrio cholerae (including El Tor)2T, V
Vibrio parahaemolyticus (Benecka parahaemolytica)2
Vibrio spp.2
Yersinia enterocolitica subsp. enterolitica2
Yersinia enterocolitica subsp. palearctica2
Yersinia pestis3
Yersinia pseudotuberculosis2
Yersinia spp.2
VIRUSES (*)See paragraph 7 of the introductory notes.NB: Viruses have been listed according to their order (O), family (F) and genus (G).
See paragraph 7 of the introductory notes.Classification according to WHO Global Action Plan to minimize poliovirus facility-associated risk after type-specific eradication of wild polioviruses and sequential cessation of oral polio vaccine use.See paragraph 8 of the introductory notes.Tick-borne encephalitis.Hepatitis delta virus is pathogenic in workers only in the presence of simultaneous or secondary infection caused by hepatitis B virus. Vaccination against hepatitis B virus will therefore protect workers who are not affected by hepatitis B virus against hepatitis delta virus.Only for types A and B.Recommended for work involving direct contact with these agents.Two viruses are identified: one a buffalopox type and the other a variant of the Vaccinia virus.Variant of cowpox virus.Variant of Vaccinia.At present there is no evidence of disease in humans caused by the other retroviruses of simian origin. As a precaution containment level 3 is recommended for work with them.
Biological agent(virus species or indicated taxonomy order)ClassificationNotes
Bunyavirales (O)
Hantaviridae (F)
Orthohantavirus (G)
Andes orthohantavirus (Hantavirus species causing Hantavirus Pulmonary Syndrome [HPS])3
Bayou orthohantavirus3
Black Creek Canal orthohantavirus3
Cano Delgadito orthohantavirus3
Choclo orthohantavirus3
Dobrava-Belgrade orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS])3
El Moro Canyon orthohantavirus3
Hantaan orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS])3
Laguna Negra orthohantavirus3
Prospect Hill orthohantavirus2
Puumala orthohantavirus (Hantavirus species causing Nephropathia Epidemica [NE])2
Seoul orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS])3
Sin Nombre orthohantavirus (Hantavirus species causing Hantavirus Pulmonary Syndrome [HPS])3
Other hantaviruses known to be pathogenic2
Nairoviridae (F)
Orthonairovirus (G)
Crimean-Congo haemorrhagic fever orthonairovirus4
Dugbe orthonairovirus2
Hazara orthonairovirus2
Nairobi sheep disease orthonairovirus2
Other nairoviruses known to be pathogenic2
Peribunyaviridae (F)
Orthobunyavirus (G)
Bunyamwera orthobunyavirus (Germiston virus)2
California encephalitis orthobunyavirus2
Oropouche orthobunyavirus3
Other orthobunyaviruses known to be pathogenic2
Phenuiviridae (F)
Phlebovirus (G)
Bhanja phlebovirus2
Punta Toro phlebovirus2
Rift Valley fever phlebovirus3
Sandfly fever Naples phlebovirus (Toscana Virus)2
SFTS phlebovirus (Severe Fever with Thrombocytopenia Syndrome-Virus)3
Other phleboviruses known to be pathogenic2
Herpesvirales (O)
Herpesviridae (F)
Cytomegalovirus (G)
Human betaherpesvirus 5 (Cytomegalovirus)2
Lymphocryptovirus (G)
Human gammaherpesvirus 4 (Epstein-Barr virus)2
Rhadinoovirus (G)
Human gammaherpesvirus 82D
Roseolovirus (G)
Human betaherpesvirus 6A (Human B-lymphotropic virus)2
Human betaherpesvirus 6B2
Human betaherpesvirus 72
Simplexvirus (G)
Macacine alphaherpesvirus 1 (Herpesvirus simiae, Herpes B virus)3
Human alphaherpesvirus 1 (Human herpesvirus 1, Herpes simplex virus type 1)2
Human alphaherpesvirus 2 (Human herpesvirus 2, Herpes simplex virus type 2)2
Varicellovirus (G)
Human alphaherpesvirus 3 (Herpesvirus varicella-zoster)2V
Mononegavirales (O)
Filoviridae (F)
Ebolavirus (G)4
Marburgvirus (G)
Marburg marburgvirus4
Paramyxoviridae (F)
Avulavirus (G)
Newcastle disease virus2
Henipavirus (G)
Hendra henipavirus4
Nipah henipavirus4
Morbillivirus (G)
Measles morbillivirus2V
Respirovirus (G)
Human respirovirus 1 (Parainfluenza virus 1)2
Human respirovirus 3 (Parainfluenza virus 3)2
Rubulavirus (G)
Mumps rubulavirus2V
Human rubulavirus 2 (Parainfluenza virus 2)2
Human rubulavirus 4 (Parainfluenza virus 4)2
Pneumoviridae (F)
Metapneumovirus (G)
Orthopneumovirus (G)
Human orthopneumovirus (Respiratory syncytial virus)2
Rhabdoviridae (F)
Lyssavirus (G)
Australian bat lyssavirus3V
Duvenhage lyssavirus3V
European bat lyssavirus 13V
European bat lyssavirus 23V
Lagos bat lyssavirus3
Mokola lyssavirus3
Rabies lyssavirus3V
Vesiculovirus (G)
Vesicular stomatitis virus, Alagoas vesiculovirus2
Vesicular stomatitis virus, Indiana vesiculovirus2
Vesicular stomatitis virus, New Jersey vesiculovirus2
Piry vesiculovirus (Piry virus)2
Nidovirales (O)
Coronaviridae (F)
Betacoronavirus (G)
Severe acute respiratory syndrome-related coronavirus (SARS-virus)3
Middle East respiratory syndrome coronavirus (MERS-virus)3
Other Coronaviridae known to be pathogenic2
Picornavirales (O)
Picornaviridae (F)
Cardiovirus (G)
Saffold virus2
Cosavirus (G)
Cosavirus A2
Enterovirus (G)
Enterovirus A2
Enterovirus B2
Enterovirus C2
Enterovirus D, Human Enterovirus type 70 (Acute haemorrhagic conjunctivitis virus)2
Rhinoviruses2
Poliovirus, type 1 and 32V
Poliovirus, type 23V
Hepatovirus (G)
Hepatovirus A (Hepatitis A virus, Human Enterovirus type 72)2V
Kobuvirus (G)
Aichivirus A (Aichi virus 1)2
Parechovirus (G)
Parechoviruses A2
Parechoviruses B (Ljungan virus)2
Other Picornaviridae known to be pathogenic2
Unassigned (O)
Adenoviridae (F)2
Astroviridae (F)2
Arenaviridae (F)
Mammarenavirus (G)
Brazilian mammarenavirus4
Chapare mammarenavirus4
Flexal mammarenavirus3
Guanarito mammarenavirus4
Junín mammarenavirus4
Lassa mammarenavirus4
Lujo mammarenavirus4
Lymphocytic choriomeningitis mammarenavirus, neurotropic strains2
Lymphocytic choriomeningitis mammarenavirus (other strains)2
Machupo mammarenavirus4
Mobala mammarenavirus2
Mopeia mammarenavirus2
Tacaribe mammarenavirus2
Whitewater Arroyo mammarenavirus3
Caliciviridae (F)
Norovirus (G)
Norovirus (Norwalk virus)2
Other Caliciviridae known to be pathogenic2
Hepadnaviridae (F)
Orthohepadnavirus (G)
Hepatitis B virus3V, D
Hepeviridae (F)
Orthohepevirus (G)
Orthohepevirus A (Hepatitis E virus)2
Flaviviridae (F)
Flavivirus (G)
Dengue virus3
Japanese encephalitis virus3V
Kyasanur Forest disease virus3V
Louping ill virus3
Murray Valley encephalitis virus (Australia encephalitis virus)3
Omsk haemorrhagic fever virus3
Powassan virus3
Rocio virus3
St. Louis encephalitis virus3
Tick-borne encephalitis virus
Absettarov virus3
Hanzalova virus3
Hypr virus3
Kumlinge virus3
Negishi virus3
Russian spring-summer encephalitis3V
Tick-borne encephalitis virus Central European subtype3V
Tick-borne encephalitis virus Far Eastern Subtype3
Tick-borne encephalitis virus Siberian subtype3V
Wesselsbron virus3
West Nile fever virus3
Yellow fever virus3V
Zika virus2
Other flaviviruses known to be pathogenic2
Hepacivirus (G)
Hepacivirus C (Hepatitis C virus)3D
Orthomyxoviridae (F)
Gammainfluenzavirus (G)
Influenza C virus2V
Influenzavirus A (G)
Highly Pathogenic Avian Influenza Viruses HPAIV (H5), e.g. H5N13
Highly Pathogenic Avian Influenza Viruses HPAIV (H7), e.g. H7N7, H7N93
Influenza A virus2V
Influenza A virus A/New York/1/18 (H1N1) (Spanish flu 1918)3
Influenza A virus A/Singapore/1/57 (H2N2)3
Low Pathogenic Avian Influenza Virus (LPAI) H7N93
Influenzavirus B (G)
Influenza B virus2V
Thogoto virus (G)
Dhori virus (Tick-borne orthomyxoviridae: Dhori)2
Thogoto virus (Tick-borne orthomyxoviridae: Thogoto)2
Papillomaviridae (F)2D
Parvoviridae (F)
Erythroparvovirus (G)
Primate erythroparvovirus 1 (Human parvovirus, B 19 virus)2
Polyomaviridae (F)
Betapolyomavirus (G)
Human polyomavirus 1 (BK virus)2D
Human polyomavirus 2 (JC virus)2D
Poxviridae (F)
Molluscipoxvirus (G)
Molluscum contagiosum virus2
Orthopoxvirus (G)
Cowpox virus2
Monkeypox virus3V
Vaccinia virus (incl. Buffalopox virus, Elephantpox virus, Rabbitpox virus)2
Variola (major and minor) virus4V
Parapoxvirus (G)
Orf virus2
Pseudocowpox virus (Milkers’ node virus, parapoxvirus bovis)2
Yatapoxvirus (G)
Tanapox virus2
Yaba monkey tumor virus2
Reoviridae (F)
Seadornavirus (G)
Banna virus2
Coltivirus (G)2
Rotaviruses (G)2
Orbivirus (G)2
Retroviridae (F)
Deltaretrovirus (G)
Primate T-lymphotropic virus 1 (Human T-cell lymphotropic virus, type 1)3D
Primate T-lymphotropic virus 2 (Human T-cell lymphotropic virus, type 2)3D
Lentivirus (G)
Human immunodeficiency virus 13D
Human immunodeficiency virus 23D
Simian Immunodeficiency Virus (SIV)2
Togaviridae (F)
Alphavirus (G)
Cabassouvirus3
Eastern equine encephalomyelitis virus3V
Bebaru virus2
Chikungunya virus3
Everglades virus3
Mayaro virus3
Mucambo virus3
Ndumu virus3
O’nyong-nyong virus2
Ross River virus2
Semliki Forest virus2
Sindbis virus2
Tonate virus3
Venezuelan equine encephalomyelitis virus3V
Western equine encephalomyelitis virus3V
Other alphaviruses known to be pathogenic2
Rubivirus (G)
Rubella virus2V
Unassigned (F)
Deltavirus (G)
Hepatitis delta virus2V, D
PRION DISEASE AGENTS
See paragraph 8 of the introductory notes.Recommended for work involving direct contact with these agents.
Biological agentClassificationNotes
Agent of Creutzfeldt-Jakob disease3D
Variant Agent of Creutzfeldt-Jakob disease3D
Agent of Bovine Spongiform Encephalopathy (BSE) and other related animal TSEs3D
Agent of Gerstmann-Sträussler-Scheinker syndrome3D
Agent of Kuru3D
Agent of Scrapie2
PARASITESNB: For biological agents appearing on this list, the entry of the whole genus with the addition of "spp." refers to other species belonging to this genus that have not specifically been included in the list, but which are known pathogens in humans. See introductory note 3 for further details.
See paragraph 8 of the introductory notes.
Biological agentClassificationNotes
Acanthamoeba castellani2
Ancylostoma duodenale2
Angiostrongylus cantonensis2
Angiostrongylus costaricensis2
Anisakis simplex2A
Ascaris lumbricoides2A
Ascaris suum2A
Babesia divergens2
Babesia microti2
Balamuthia mandrillaris3
Balantidium coli2
Brugia malayi2
Brugia pahangi2
Brugia timori2
Capillaria philippinensis2
Capillaria spp.2
Clonorchis sinensis (Opisthorchis sinensis)2
Clonorchis viverrini (Opisthirchis viverrini)2
Cryptosporidium hominis2
Cryptosporidium parvum2
Cyclospora cayetanensis2
Dicrocoelium dentriticum2
Dipetalonema streptocerca2
Diphyllobothrium latum2
Dracunculus medinensis2
Echinococcus granulosus3
Echinococcus multilocularis3
Echinococcus oligarthrus3
Echinococcus vogeli3
Entamoeba histolytica2
Enterobius vermicularis2
Enterocytozoon bieneusi2
Fasciola gigantica2
Fasciola hepatica2
Fasciolopsis buski2
Giardia lamblia (Giardia duodenalis, Giardia intestinalis)2
Heterophyes spp.2
Hymenolepis diminuta2
Hymenolepis nana2
Leishmania aethiopica2
Leishmania braziliensis3
Leishmania donovani3
Leishmania guyanensis (Viannia guyanensis)3
Leishmania infantum (Leishmania chagasi)3
Leishmania major2
Leishmania mexicana2
Leishmania panamensis (Viannia panamensis)3
Leishmania peruviana2
Leishmania tropica2
Leishmania spp.2
Loa loa2
Mansonella ozzardi2
Mansonella perstans2
Mansonella streptocerca2
Metagonimus spp.2
Naegleria fowleri3
Necator americanus2
Onchocerca volvulus2
Opisthorchis felineus2
Opisthorchis spp.2
Paragonimus westermani2
Paragonimus spp.2
Plasmodium falciparum3
Plasmodium knowlesi3
Plasmodium spp. (human and simian)2
Sarcocystis suihominis2
Schistosoma haematobium2
Schistosoma intercalatum2
Schistosoma japonicum2
Schistosoma mansoni2
Schistosoma mekongi2
Strongyloides stercoralis2
Strongyloides spp.2
Taenia saginata2
Taenia solium3
Toxocara canis2
Toxocara cati2
Toxoplasma gondii2
Trichinella nativa2
Trichinella nelsoni2
Trichinella pseudospiralis2
Trichinella spiralis2
Trichomonas vaginalis2
Trichostrongylus orientalis2
Trichostrongylus spp.2
Trichuris trichiura2
Trypanosoma brucei brucei2
Trypanosoma brucei gambiense2
Trypanosoma brucei rhodesiense3
Trypanosoma cruzi3
Wuchereria bancrofti2
FUNGINB: For biological agents appearing on this list, the entry of the whole genus with the addition of "spp." refers to other species belonging to this genus that have not specifically been included in the list, but which are known pathogens in humans. See introductory note 3 for further details.
Biological agentClassificationNotes
Aspergillus flavus2A
Aspergillus fumigatus2A
Aspergillus spp.2
Blastomyces dermatitidis (Ajellomyces dermatitidis)3
Blastomyces gilchristii3
Candida albicans2A
Candida dubliniensis2
Candida glabrata2
Candida parapsilosis2
Candida tropicalis2
Cladophialophora bantiana (Xylohypha bantiana, Cladosporium bantianum,trichoides)3
Cladophialophora modesta3
Cladophialophora spp.2
Coccidioides immitis3A
Coccidioides posadasii3A
Cryptococcus gattii (Filobasidiella neoformans var. bacillispora)2A
Cryptococcus neoformans (Filobasidiella neoformans var. neoformans)2A
Emmonsia parva var. parva2
Emmonsia parva var. crescens2
Epidermophyton floccosum2A
Epidermophyton spp.2
Fonsecaea pedrosoi2
Histoplasma capsulatum3
Histoplasma capsulatum var. farciminosum3
Histoplasma duboisii3
Madurella grisea2
Madurella mycetomatis2
Microsporum spp.2A
Nannizzia spp.2
Neotestudina rosatii2
Paracoccidioides brasiliensis3A
Paracoccidioides lutzii3
Paraphyton spp.2
Rhinocladiella mackenziei3
Scedosporium apiospermum2
Scedosporium prolificans (inflatum)2
Sporothrix schenckii2
Talaromyces marneffei (Penicillium marneffei)2A
Trichophyton rubrum2A
Trichophyton tonsurans2A
Trichophyton spp.2"
----------------------
See paragraph 8 of the introductory notes.See paragraph 7 of the introductory notes.Classification according to WHO Global Action Plan to minimize poliovirus facility-associated risk after type-specific eradication of wild polioviruses and sequential cessation of oral polio vaccine use.See paragraph 8 of the introductory notes.Tick-borne encephalitis.Hepatitis delta virus is pathogenic in workers only in the presence of simultaneous or secondary infection caused by hepatitis B virus. Vaccination against hepatitis B virus will therefore protect workers who are not affected by hepatitis B virus against hepatitis delta virus.Only for types A and B.Recommended for work involving direct contact with these agents.Two viruses are identified: one a buffalopox type and the other a variant of the Vaccinia virus.Variant of cowpox virus.Variant of Vaccinia.At present there is no evidence of disease in humans caused by the other retroviruses of simian origin. As a precaution containment level 3 is recommended for work with them.See paragraph 8 of the introductory notes.Recommended for work involving direct contact with these agents.See paragraph 8 of the introductory notes.
(3)Annex V to Directive 2000/54/EC is replaced by the following:"ANNEX VINDICATIONS CONCERNING CONTAINMENT MEASURES AND CONTAINMENT LEVELS(Articles 15(3) and 16(1)(a) and (b))Preliminary noteThe measures contained in this Annex shall be applied according to the nature of the activities, the assessment of risk to workers, and the nature of the biological agent concerned.In the table, "Recommended" means that the measures should in principle be applied, unless the results of the assessment referred to in Article 3(2) indicate otherwise.
HEPA: High efficiency particulate airAirlock: Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors.
A. Containment measuresB. Containment levels
234
Workplace
1. The workplace is to be separated from any other activities in the same buildingNoRecommendedYes
2. The workplace is to be sealable to permit fumigationNoRecommendedYes
Facilities
3. Infected material including any animal is to be handled in a safety cabinet or isolation or other suitable containmentWhere appropriateYes, where infection is by airborne routeYes
Equipment
4. Input air and extract air to the workplace are to be filtered using (HEPA) or likewiseNoYes, on extract airYes, on input and extract air
5. The workplace is to be maintained at an air pressure negative to atmosphereNoRecommendedYes
6. Surfaces impervious to water and easy to cleanYes, for bench and floorYes, for bench, floor and other surfaces determined by risk assessmentYes, for bench, walls, floor and ceiling
7. Surfaces resistant to acids, alkalis, solvents, disinfectantsRecommendedYesYes
System of work
8. Access is to be restricted to nominated workers onlyRecommendedYesYes, via airlock
9. Efficient vector control, for example rodents and insectsRecommendedYesYes
10. Specified disinfection proceduresYesYesYes
11. Safe storage of a biological agentYesYesYes, secure storage
12. Personnel should shower before leaving the contained areaNoRecommendedRecommended
Waste
13. Validated inactivation process for the safe disposal of animal carcasesRecommendedYes, on or off siteYes, on site
Other measures
14. A laboratory is to contain its own equipmentNoRecommendedYes
15. An observation window, or, alternative, is to be present, so that occupants can be seenRecommendedRecommendedYes"
----------------------
HEPA: High efficiency particulate airAirlock: Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors.
(4)Annex VI to Directive 2000/54/EC is replaced by the following:"ANNEX VICONTAINMENT FOR INDUSTRIAL PROCESSES(Article 4(1) and Article 16(2)(a))Preliminary noteIn the table, "Recommended" means that the measures should in principle be applied, unless the results of the assessment referred to in Article 3(2) indicate otherwise.Group 1 biological agentsFor work with group 1 biological agents including live attenuated vaccines, the principles of good occupational safety and hygiene should be observed.Groups 2, 3 and 4 biological agentsIt may be appropriate to select and combine containment requirements from different categories below on the basis of a risk assessment related to any particular process or part of a process.
HEPA: High efficiency particulate airClosed system: A system that physically separates the process from the environment (e.g. incubator vats, tanks, etc.).Airlock: Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors.
A. Containment measuresB. Containment levels
234
General
1. Viable organisms should be handled in a system which physically separates the process from the environmentYesYesYes
2. Exhaust gases from the closed system should be treated so as to:Minimise releasePrevent releasePrevent release
3. Sample collection, addition of materials to a closed system and transfer of viable organisms to another closed system, should be performed so as to:Minimise releasePrevent releasePrevent release
4. Bulk culture fluids should not be removed from the closed system unless the viable organisms have been:Inactivated by validated chemical or physical meansInactivated by validated chemical or physical meansInactivated by validated chemical or physical means
5. Seals should be designed so as to:Minimise releasePrevent releasePrevent release
6. The controlled area should be designed to contain spillage of the entire contents of the closed systemNoRecommendedYes
7. The controlled area should be sealable to permit fumigationNoRecommendedYes
Facilities
8. Decontamination and washing facilities should be provided for personnelYesYesYes
Equipment
9. Input air and extract air to the controlled area should be HEPA filteredNoRecommendedYes
10. The controlled area should be maintained at an air pressure negative to atmosphereNoRecommendedYes
11. The controlled area should be adequately ventilated to minimise air contaminationRecommendedRecommendedYes
System of work
12. Closed systems should be located within a controlled areaRecommendedRecommendedYes, and purpose-built
13. Biohazard signs should be postedRecommendedYesYes
14. Access should be restricted to nominated personnel onlyRecommendedYesYes, via an airlock
15. Personnel should shower before leaving the controlled areaNoRecommendedYes
16. Personnel should wear protective clothingYes, work clothingYesYes, complete change
Waste
17. Effluent from sinks and showers should be collected and inactivated before releaseNoRecommendedYes
18. Effluent treatment before final dischargeInactivated by validated chemical or physical meansInactivated by validated chemical or physical meansInactivated by validated chemical or physical means"
----------------------
HEPA: High efficiency particulate airClosed system: A system that physically separates the process from the environment (e.g. incubator vats, tanks, etc.).Airlock: Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors.

Article 1Annexes I, III, V and VI to Directive 2000/54/EC are replaced by the text in the Annex to this Directive.
Article 21.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20 November 2021 at the latest. However, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the amendments to Annexes V and VI to Directive 2000/54/EC, insofar as they relate to the biological agent SARS-CoV-2, by 24 November 2020 at the latest.They shall forthwith communicate to the Commission the text of the provisions referred to in the first subparagraph.When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 4This Directive is addressed to the Member States.
nullANNEX(1)Annex I to Directive 2000/54/EC is replaced by the following:"ANNEX IINDICATIVE LIST OF ACTIVITIES(Article 4(2))Preliminary noteWhere the result of the risk assessment, carried out in accordance with Article 3 and Article 4(2) of this Directive, shows an unintentional exposure to biological agents, there may be other work activities, not included in this Annex, which should be considered.1.Work in food production plants.2.Work in agriculture.3.Work activities where there is contact with animals and/or products of animal origin.4.Work in healthcare, including isolation and post-mortem units.5.Work in clinical, veterinary and diagnostic laboratories, excluding diagnostic microbiological laboratories.6.Work in refuse disposal plants.7.Work in sewage purification installations."(2)Annex III to Directive 2000/54/EC is replaced by the following:"ANNEX IIICOMMUNITY CLASSIFICATIONArticle 2, second paragraph, and Article 18INTRODUCTORY NOTES1.In line with the scope of the Directive, only agents which are known to infect humans are to be included in the classified list.Where appropriate, indicators are given of the toxic and allergic potential of these agents.Animal and plant pathogens which are known not to affect man are excluded.In drawing up this list of classified biological agents consideration has not been given to genetically modified micro-organisms.2.The list of classified agents is based on the effect of those agents on healthy workers.No specific account is taken of particular effects on those whose susceptibility may be affected for one or other reason such as pre-existing disease, medication, compromised immunity, pregnancy or breast feeding.Additional risk to such workers should be considered as part of the risk assessment required by the Directive.In certain industrial processes, certain laboratory work or certain work with animals involving actual or potential exposure to biological agents of groups 3 or 4, any technical precautions taken must comply with Article 16 of the Directive.3.Biological agents which have not been classified for inclusion in groups 2 to 4 of the list are not implicitly classified in group 1.For genera where more than one species is known to be pathogenic to man, the list will include those species which are known to be the most frequently responsible for diseases, together with a more general reference to the fact that other species of the same genus may affect health.When a whole genus is mentioned in the classified list of biological agents, it is implicit that the species and strains known to be non-pathogenic are excluded.4.Where a strain is attenuated or has lost known virulence genes, then the containment required by the classification of its parent strain need not necessarily apply, subject to assessment appropriate for risk in the workplace.This is the case, for example, when such a strain is to be used as a product or part of a product for prophylactic or therapeutic purposes.5.The nomenclature of classified agents used to establish this list reflects and is in conformity with the latest international agreements of the taxonomy and nomenclature of agents at the time the list was prepared.6.The list of classified biological agents reflects the state of knowledge at the time that it was devised.It will be updated as soon as it no longer reflects the latest state of knowledge.7.Member States are to ensure that all viruses which have already been isolated in humans and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.8.Certain biological agents classified in group 3 which are indicated in the appended list by two asterisks (**), may present a limited risk of infection for workers because they are not normally infectious by the airborne route.Member States shall assess the containment measures to be applied to such agents, taking account of the nature of specific activities in question and of the quantity of the agent involved, with a view to determining whether, in particular circumstances, some of these measures may be dispensed with.9.The requirements as to containment consequent on the classification of parasites apply only to stages in the life cycle of the parasite in which it is liable to be infectious to humans at the workplace.10.This list also gives a separate indication in cases where the biological agents are likely to cause allergic or toxic reactions, where an effective vaccine is available, or where it is advisable to keep a list of exposed workers for more than 10 years.These indications are shown by the following letters:A:Possible allergic effectsD:List of workers exposed to this biological agent to be kept for more than 10 years after the end of last known exposureT:Toxin productionV:Effective vaccine available and registered within the EUThe application of preventive vaccination should take account of the code of practice given in Annex VII.BACTERIAand similar organismsNB: For biological agents appearing on this list, the entry of the whole genus with the addition of "spp." refers to other species belonging to this genus that have not specifically been included in the list, but which are known pathogens in humans. See introductory note 3 for further details.
See paragraph 8 of the introductory notes.
Biological agentClassificationNotes
Actinomadura maduraeW
Actinomadura pelletieri2
Actinomyces gerencseriae2
Actinomyces israelii2
Actinomyces spp.2
Aggregatibacter actinomycetemcomitans (Actinobacillus actinomycetemcomitans)2
Anaplasma spp.2
Arcanobacterium haemolyticum (Corynebacterium haenolyticum)2
Arcobacter butzleri2
Bacillus anthracis3T
Bacteroides fragilis2
Bacteroides spp.2
Bartonella bacilliformis2
Bartonella quintana (Rochalimaea quintana)2
Bartonella (Rochalimaea) spp.2
Bordetella bronchiseptica2
Bordetella parapertussis2
Bordetella pertussis2T, V
Bordetella spp.2
Borrelia burgdorferi2
Borrelia duttonii2
Borrelia recurrentis2
Borrelia spp.2
Brachyspira spp.2
Brucella abortus3
Brucella canis3
Brucella inopinata3
Brucella melitensis3
Brucella suis3
Burkholderia cepacia2
Burkholderia mallei (Pseudomonas mallei)3
Burkholderia pseudomallei (Pseudomonas pseudomallei)3D
Campylobacter fetus subsp. fetus2
Campylobacter fetus subsp. venerealis2
Campylobacter jejuni subsp. doylei2
Campylobacter jejuni subsp. jejuni2
Campylobacter spp.2
Cardiobacterium hominis2
Cardiobacterium valvarum2
Chlamydia abortus (Chlamydophila abortus)2
Chlamydia caviae (Chlamydophila caviae)2
Chlamydia felis (Chlamydophila felis)2
Chlamydia pneumoniae (Chlamydophila pneumoniae)2
Chlamydia psittaci (Chlamydophila psittaci) (avian strains)3
Chlamydia psittaci (Chlamydophila psittaci) (other strains)2
Chlamydia trachomatis (Chlamydophila trachomatis)2
Clostridium botulinum2T
Clostridium difficile2T
Clostridium perfringens2T
Clostridium tetani2T, V
Clostridium spp.2
Corynebacterium diphtheriae2T, V
Corynebacterium minutissimum2
Corynebacterium pseudotuberculosis2T
Corynebacterium ulcerans2T
Corynebacterium spp.2
Coxiella burnetii3
Edwardsiella tarda2
Ehrlichia spp.2
Eikenella corrodens2
Elizabethkingia meningoseptica (Flavobacterium meningosepticum)2
Enterobacter aerogenes (Klebsiella mobilis)2
Enterobacter cloacae subsp. cloacae (Enterobacter cloacae)2
Enterobacter spp.2
Enterococcus spp.2
Erysipelothrix rhusiopathiae2
Escherichia coli (with the exception of non-pathogenic strains)2
Escherichia coli, verocytotoxigenic strains (e.g. O157:H7 or O103)3T
Fluoribacter bozemanae (Legionella)2
Francisella hispaniensis2
Francisella tularensis subsp. holarctica2
Francisella tularensis subsp. mediasiatica2
Francisella tularensis subsp. novicida2
Francisella tularensis subsp. tularensis3
Fusobacterium necrophorum subsp. funduliforme2
Fusobacterium necrophorum subsp. necrophorum2
Gardnerella vaginalis2
Haemophilus ducreyi2
Haemophilus influenzae2V
Haemophilus spp.2
Helicobacter pylori2
Helicobacter spp.2
Klebsiella oxytoca2
Klebsiella pneumoniae subsp. ozaenae2
Klebsiella pneumoniae subsp. pneumoniae2
Klebsiella pneumoniae subsp. rhinoscleromatis2
Klebsiella spp.2
Legionella pneumophila subsp. fraseri2
Legionella pneumophila subsp. pascullei2
Legionella pneumophila subsp. pneumophila2
Legionella spp.2
Leptospira interrogans (all serovars)2
Leptospira interrogans spp.2
Listeria monocytogenes2
Listeria ivanovii subsp. ivanovii2
Listeria invanovii subsp. londoniensis2
Morganella morganii subsp. morganii (Proteus morganii)2
Morganella morganii subsp. sibonii2
Mycobacterium abscessus subsp. abscessus2
Mycobacterium africanum3V
Mycobacterium avium subsp. avium (Mycobacterium avium)2
Mycobacterium avium subsp. paratuberculosis (Mycobacterium paratuberculosis)2
Mycobacterium avium subsp. silvaticum2
Mycobacterium bovis3V
Mycobacterium caprae (Mycobacterium tuberculosis subsp. caprae)3
Mycobacterium chelonae2
Mycobacterium chimaera2
Mycobacterium fortuitum2
Mycobacterium intracellulare2
Mycobacterium kansasii2
Mycobacterium leprae3
Mycobacterium malmoense2
Mycobacterium marinum2
Mycobacterium microti3
Mycobacterium pinnipedii3
Mycobacterium scrofulaceum2
Mycobacterium simiae2
Mycobacterium szulgai2
Mycobacterium tuberculosis3V
Mycobacterium ulcerans3
Mycobacterium xenopi2
Mycoplasma hominis2
Mycoplasma pneumoniae2
Mycoplasma spp.2
Neisseria gonorrhoeae2
Neisseria meningitidis2V
Neorickettsia sennetsu (Rickettsia sennetsu, Ehrlichia sennetsu)2
Nocardia asteroides2
Nocardia brasiliensis2
Nocardia farcinica2
Nocardia nova2
Nocardia otitidiscaviarum2
Nocardia spp.2
Orientia tsutsugamushi (Rickettsia tsutsugamushi)3
Pasteurella multocida subsp. gallicida (Pasteurella gallicida)2
Pasteurella multocida subsp. multocida2
Pasteurella multocida subsp. septica2
Pasteurella spp.2
Peptostreptococcus anaerobius2
Plesiomonas shigelloides2
Porphyromonas spp.2
Prevotella spp.2
Proteus mirabilis2
Proteus penneri2
Proteus vulgaris2
Providencia alcalifaciens (Proteus inconstans)2
Providencia rettgeri (Proteus rettgeri)2
Providencia spp.2
Pseudomonas aeruginosa2T
Rhodococcus hoagii (Corynebacterium equii)2
Rickettsia africae3
Rickettsia akari3
Rickettsia australis3
Rickettsia canadensis2
Rickettsia conorii3
Rickettsia heilongjiangensis3
Rickettsia japonica3
Rickettsia montanensis2
Rickettsia typhi3
Rickettsia prowazekii3
Rickettsia rickettsii3
Rickettsia sibirica3
Rickettsia spp.2
Salmonella enterica (choleraesuis) subsp. arizonae2
Salmonella Enteritidis2
Salmonella Paratyphi A, B, C2V
Salmonella Typhi3V
Salmonella Typhimurium2
Salmonella (other serovars)2
Shigella boydii2
Shigella dysenteriae (Type 1)3T
Shigella dysenteriae, other than Type 12
Shigella flexneri2
Shigella sonnei2
Staphylococcus aureus2T
Streptobacillus moniliformis2
Streptococcus agalactiae2
Streptococcus dysgalactiae subsp. equisimilis2
Streptococcus pneumoniae2T, V
Streptococcus pyogenes2T
Streptococcus suis2
Streptococcus spp.2
Treponema carateum2
Treponema pallidum2
Treponema pertenue2
Treponema spp.2
Trueperella pyogenes2
Ureaplasma parvum2
Ureaplasma urealyticum2
Vibrio cholerae (including El Tor)2T, V
Vibrio parahaemolyticus (Benecka parahaemolytica)2
Vibrio spp.2
Yersinia enterocolitica subsp. enterolitica2
Yersinia enterocolitica subsp. palearctica2
Yersinia pestis3
Yersinia pseudotuberculosis2
Yersinia spp.2
VIRUSES (*)See paragraph 7 of the introductory notes.NB: Viruses have been listed according to their order (O), family (F) and genus (G).
See paragraph 7 of the introductory notes.Classification according to WHO Global Action Plan to minimize poliovirus facility-associated risk after type-specific eradication of wild polioviruses and sequential cessation of oral polio vaccine use.See paragraph 8 of the introductory notes.Tick-borne encephalitis.Hepatitis delta virus is pathogenic in workers only in the presence of simultaneous or secondary infection caused by hepatitis B virus. Vaccination against hepatitis B virus will therefore protect workers who are not affected by hepatitis B virus against hepatitis delta virus.Only for types A and B.Recommended for work involving direct contact with these agents.Two viruses are identified: one a buffalopox type and the other a variant of the Vaccinia virus.Variant of cowpox virus.Variant of Vaccinia.At present there is no evidence of disease in humans caused by the other retroviruses of simian origin. As a precaution containment level 3 is recommended for work with them.
Biological agent(virus species or indicated taxonomy order)ClassificationNotes
Bunyavirales (O)
Hantaviridae (F)
Orthohantavirus (G)
Andes orthohantavirus (Hantavirus species causing Hantavirus Pulmonary Syndrome [HPS])3
Bayou orthohantavirus3
Black Creek Canal orthohantavirus3
Cano Delgadito orthohantavirus3
Choclo orthohantavirus3
Dobrava-Belgrade orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS])3
El Moro Canyon orthohantavirus3
Hantaan orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS])3
Laguna Negra orthohantavirus3
Prospect Hill orthohantavirus2
Puumala orthohantavirus (Hantavirus species causing Nephropathia Epidemica [NE])2
Seoul orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS])3
Sin Nombre orthohantavirus (Hantavirus species causing Hantavirus Pulmonary Syndrome [HPS])3
Other hantaviruses known to be pathogenic2
Nairoviridae (F)
Orthonairovirus (G)
Crimean-Congo haemorrhagic fever orthonairovirus4
Dugbe orthonairovirus2
Hazara orthonairovirus2
Nairobi sheep disease orthonairovirus2
Other nairoviruses known to be pathogenic2
Peribunyaviridae (F)
Orthobunyavirus (G)
Bunyamwera orthobunyavirus (Germiston virus)2
California encephalitis orthobunyavirus2
Oropouche orthobunyavirus3
Other orthobunyaviruses known to be pathogenic2
Phenuiviridae (F)
Phlebovirus (G)
Bhanja phlebovirus2
Punta Toro phlebovirus2
Rift Valley fever phlebovirus3
Sandfly fever Naples phlebovirus (Toscana Virus)2
SFTS phlebovirus (Severe Fever with Thrombocytopenia Syndrome-Virus)3
Other phleboviruses known to be pathogenic2
Herpesvirales (O)
Herpesviridae (F)
Cytomegalovirus (G)
Human betaherpesvirus 5 (Cytomegalovirus)2
Lymphocryptovirus (G)
Human gammaherpesvirus 4 (Epstein-Barr virus)2
Rhadinoovirus (G)
Human gammaherpesvirus 82D
Roseolovirus (G)
Human betaherpesvirus 6A (Human B-lymphotropic virus)2
Human betaherpesvirus 6B2
Human betaherpesvirus 72
Simplexvirus (G)
Macacine alphaherpesvirus 1 (Herpesvirus simiae, Herpes B virus)3
Human alphaherpesvirus 1 (Human herpesvirus 1, Herpes simplex virus type 1)2
Human alphaherpesvirus 2 (Human herpesvirus 2, Herpes simplex virus type 2)2
Varicellovirus (G)
Human alphaherpesvirus 3 (Herpesvirus varicella-zoster)2V
Mononegavirales (O)
Filoviridae (F)
Ebolavirus (G)4
Marburgvirus (G)
Marburg marburgvirus4
Paramyxoviridae (F)
Avulavirus (G)
Newcastle disease virus2
Henipavirus (G)
Hendra henipavirus4
Nipah henipavirus4
Morbillivirus (G)
Measles morbillivirus2V
Respirovirus (G)
Human respirovirus 1 (Parainfluenza virus 1)2
Human respirovirus 3 (Parainfluenza virus 3)2
Rubulavirus (G)
Mumps rubulavirus2V
Human rubulavirus 2 (Parainfluenza virus 2)2
Human rubulavirus 4 (Parainfluenza virus 4)2
Pneumoviridae (F)
Metapneumovirus (G)
Orthopneumovirus (G)
Human orthopneumovirus (Respiratory syncytial virus)2
Rhabdoviridae (F)
Lyssavirus (G)
Australian bat lyssavirus3V
Duvenhage lyssavirus3V
European bat lyssavirus 13V
European bat lyssavirus 23V
Lagos bat lyssavirus3
Mokola lyssavirus3
Rabies lyssavirus3V
Vesiculovirus (G)
Vesicular stomatitis virus, Alagoas vesiculovirus2
Vesicular stomatitis virus, Indiana vesiculovirus2
Vesicular stomatitis virus, New Jersey vesiculovirus2
Piry vesiculovirus (Piry virus)2
Nidovirales (O)
Coronaviridae (F)
Betacoronavirus (G)
Severe acute respiratory syndrome-related coronavirus (SARS-virus)3
Middle East respiratory syndrome coronavirus (MERS-virus)3
Other Coronaviridae known to be pathogenic2
Picornavirales (O)
Picornaviridae (F)
Cardiovirus (G)
Saffold virus2
Cosavirus (G)
Cosavirus A2
Enterovirus (G)
Enterovirus A2
Enterovirus B2
Enterovirus C2
Enterovirus D, Human Enterovirus type 70 (Acute haemorrhagic conjunctivitis virus)2
Rhinoviruses2
Poliovirus, type 1 and 32V
Poliovirus, type 23V
Hepatovirus (G)
Hepatovirus A (Hepatitis A virus, Human Enterovirus type 72)2V
Kobuvirus (G)
Aichivirus A (Aichi virus 1)2
Parechovirus (G)
Parechoviruses A2
Parechoviruses B (Ljungan virus)2
Other Picornaviridae known to be pathogenic2
Unassigned (O)
Adenoviridae (F)2
Astroviridae (F)2
Arenaviridae (F)
Mammarenavirus (G)
Brazilian mammarenavirus4
Chapare mammarenavirus4
Flexal mammarenavirus3
Guanarito mammarenavirus4
Junín mammarenavirus4
Lassa mammarenavirus4
Lujo mammarenavirus4
Lymphocytic choriomeningitis mammarenavirus, neurotropic strains2
Lymphocytic choriomeningitis mammarenavirus (other strains)2
Machupo mammarenavirus4
Mobala mammarenavirus2
Mopeia mammarenavirus2
Tacaribe mammarenavirus2
Whitewater Arroyo mammarenavirus3
Caliciviridae (F)
Norovirus (G)
Norovirus (Norwalk virus)2
Other Caliciviridae known to be pathogenic2
Hepadnaviridae (F)
Orthohepadnavirus (G)
Hepatitis B virus3V, D
Hepeviridae (F)
Orthohepevirus (G)
Orthohepevirus A (Hepatitis E virus)2
Flaviviridae (F)
Flavivirus (G)
Dengue virus3
Japanese encephalitis virus3V
Kyasanur Forest disease virus3V
Louping ill virus3
Murray Valley encephalitis virus (Australia encephalitis virus)3
Omsk haemorrhagic fever virus3
Powassan virus3
Rocio virus3
St. Louis encephalitis virus3
Tick-borne encephalitis virus
Absettarov virus3
Hanzalova virus3
Hypr virus3
Kumlinge virus3
Negishi virus3
Russian spring-summer encephalitis3V
Tick-borne encephalitis virus Central European subtype3V
Tick-borne encephalitis virus Far Eastern Subtype3
Tick-borne encephalitis virus Siberian subtype3V
Wesselsbron virus3
West Nile fever virus3
Yellow fever virus3V
Zika virus2
Other flaviviruses known to be pathogenic2
Hepacivirus (G)
Hepacivirus C (Hepatitis C virus)3D
Orthomyxoviridae (F)
Gammainfluenzavirus (G)
Influenza C virus2V
Influenzavirus A (G)
Highly Pathogenic Avian Influenza Viruses HPAIV (H5), e.g. H5N13
Highly Pathogenic Avian Influenza Viruses HPAIV (H7), e.g. H7N7, H7N93
Influenza A virus2V
Influenza A virus A/New York/1/18 (H1N1) (Spanish flu 1918)3
Influenza A virus A/Singapore/1/57 (H2N2)3
Low Pathogenic Avian Influenza Virus (LPAI) H7N93
Influenzavirus B (G)
Influenza B virus2V
Thogoto virus (G)
Dhori virus (Tick-borne orthomyxoviridae: Dhori)2
Thogoto virus (Tick-borne orthomyxoviridae: Thogoto)2
Papillomaviridae (F)2D
Parvoviridae (F)
Erythroparvovirus (G)
Primate erythroparvovirus 1 (Human parvovirus, B 19 virus)2
Polyomaviridae (F)
Betapolyomavirus (G)
Human polyomavirus 1 (BK virus)2D
Human polyomavirus 2 (JC virus)2D
Poxviridae (F)
Molluscipoxvirus (G)
Molluscum contagiosum virus2
Orthopoxvirus (G)
Cowpox virus2
Monkeypox virus3V
Vaccinia virus (incl. Buffalopox virus, Elephantpox virus, Rabbitpox virus)2
Variola (major and minor) virus4V
Parapoxvirus (G)
Orf virus2
Pseudocowpox virus (Milkers’ node virus, parapoxvirus bovis)2
Yatapoxvirus (G)
Tanapox virus2
Yaba monkey tumor virus2
Reoviridae (F)
Seadornavirus (G)
Banna virus2
Coltivirus (G)2
Rotaviruses (G)2
Orbivirus (G)2
Retroviridae (F)
Deltaretrovirus (G)
Primate T-lymphotropic virus 1 (Human T-cell lymphotropic virus, type 1)3D
Primate T-lymphotropic virus 2 (Human T-cell lymphotropic virus, type 2)3D
Lentivirus (G)
Human immunodeficiency virus 13D
Human immunodeficiency virus 23D
Simian Immunodeficiency Virus (SIV)2
Togaviridae (F)
Alphavirus (G)
Cabassouvirus3
Eastern equine encephalomyelitis virus3V
Bebaru virus2
Chikungunya virus3
Everglades virus3
Mayaro virus3
Mucambo virus3
Ndumu virus3
O’nyong-nyong virus2
Ross River virus2
Semliki Forest virus2
Sindbis virus2
Tonate virus3
Venezuelan equine encephalomyelitis virus3V
Western equine encephalomyelitis virus3V
Other alphaviruses known to be pathogenic2
Rubivirus (G)
Rubella virus2V
Unassigned (F)
Deltavirus (G)
Hepatitis delta virus2V, D
PRION DISEASE AGENTS
See paragraph 8 of the introductory notes.Recommended for work involving direct contact with these agents.
Biological agentClassificationNotes
Agent of Creutzfeldt-Jakob disease3D
Variant Agent of Creutzfeldt-Jakob disease3D
Agent of Bovine Spongiform Encephalopathy (BSE) and other related animal TSEs3D
Agent of Gerstmann-Sträussler-Scheinker syndrome3D
Agent of Kuru3D
Agent of Scrapie2
PARASITESNB: For biological agents appearing on this list, the entry of the whole genus with the addition of "spp." refers to other species belonging to this genus that have not specifically been included in the list, but which are known pathogens in humans. See introductory note 3 for further details.
See paragraph 8 of the introductory notes.
Biological agentClassificationNotes
Acanthamoeba castellani2
Ancylostoma duodenale2
Angiostrongylus cantonensis2
Angiostrongylus costaricensis2
Anisakis simplex2A
Ascaris lumbricoides2A
Ascaris suum2A
Babesia divergens2
Babesia microti2
Balamuthia mandrillaris3
Balantidium coli2
Brugia malayi2
Brugia pahangi2
Brugia timori2
Capillaria philippinensis2
Capillaria spp.2
Clonorchis sinensis (Opisthorchis sinensis)2
Clonorchis viverrini (Opisthirchis viverrini)2
Cryptosporidium hominis2
Cryptosporidium parvum2
Cyclospora cayetanensis2
Dicrocoelium dentriticum2
Dipetalonema streptocerca2
Diphyllobothrium latum2
Dracunculus medinensis2
Echinococcus granulosus3
Echinococcus multilocularis3
Echinococcus oligarthrus3
Echinococcus vogeli3
Entamoeba histolytica2
Enterobius vermicularis2
Enterocytozoon bieneusi2
Fasciola gigantica2
Fasciola hepatica2
Fasciolopsis buski2
Giardia lamblia (Giardia duodenalis, Giardia intestinalis)2
Heterophyes spp.2
Hymenolepis diminuta2
Hymenolepis nana2
Leishmania aethiopica2
Leishmania braziliensis3
Leishmania donovani3
Leishmania guyanensis (Viannia guyanensis)3
Leishmania infantum (Leishmania chagasi)3
Leishmania major2
Leishmania mexicana2
Leishmania panamensis (Viannia panamensis)3
Leishmania peruviana2
Leishmania tropica2
Leishmania spp.2
Loa loa2
Mansonella ozzardi2
Mansonella perstans2
Mansonella streptocerca2
Metagonimus spp.2
Naegleria fowleri3
Necator americanus2
Onchocerca volvulus2
Opisthorchis felineus2
Opisthorchis spp.2
Paragonimus westermani2
Paragonimus spp.2
Plasmodium falciparum3
Plasmodium knowlesi3
Plasmodium spp. (human and simian)2
Sarcocystis suihominis2
Schistosoma haematobium2
Schistosoma intercalatum2
Schistosoma japonicum2
Schistosoma mansoni2
Schistosoma mekongi2
Strongyloides stercoralis2
Strongyloides spp.2
Taenia saginata2
Taenia solium3
Toxocara canis2
Toxocara cati2
Toxoplasma gondii2
Trichinella nativa2
Trichinella nelsoni2
Trichinella pseudospiralis2
Trichinella spiralis2
Trichomonas vaginalis2
Trichostrongylus orientalis2
Trichostrongylus spp.2
Trichuris trichiura2
Trypanosoma brucei brucei2
Trypanosoma brucei gambiense2
Trypanosoma brucei rhodesiense3
Trypanosoma cruzi3
Wuchereria bancrofti2
FUNGINB: For biological agents appearing on this list, the entry of the whole genus with the addition of "spp." refers to other species belonging to this genus that have not specifically been included in the list, but which are known pathogens in humans. See introductory note 3 for further details.
Biological agentClassificationNotes
Aspergillus flavus2A
Aspergillus fumigatus2A
Aspergillus spp.2
Blastomyces dermatitidis (Ajellomyces dermatitidis)3
Blastomyces gilchristii3
Candida albicans2A
Candida dubliniensis2
Candida glabrata2
Candida parapsilosis2
Candida tropicalis2
Cladophialophora bantiana (Xylohypha bantiana, Cladosporium bantianum,trichoides)3
Cladophialophora modesta3
Cladophialophora spp.2
Coccidioides immitis3A
Coccidioides posadasii3A
Cryptococcus gattii (Filobasidiella neoformans var. bacillispora)2A
Cryptococcus neoformans (Filobasidiella neoformans var. neoformans)2A
Emmonsia parva var. parva2
Emmonsia parva var. crescens2
Epidermophyton floccosum2A
Epidermophyton spp.2
Fonsecaea pedrosoi2
Histoplasma capsulatum3
Histoplasma capsulatum var. farciminosum3
Histoplasma duboisii3
Madurella grisea2
Madurella mycetomatis2
Microsporum spp.2A
Nannizzia spp.2
Neotestudina rosatii2
Paracoccidioides brasiliensis3A
Paracoccidioides lutzii3
Paraphyton spp.2
Rhinocladiella mackenziei3
Scedosporium apiospermum2
Scedosporium prolificans (inflatum)2
Sporothrix schenckii2
Talaromyces marneffei (Penicillium marneffei)2A
Trichophyton rubrum2A
Trichophyton tonsurans2A
Trichophyton spp.2"
----------------------
See paragraph 8 of the introductory notes.See paragraph 7 of the introductory notes.Classification according to WHO Global Action Plan to minimize poliovirus facility-associated risk after type-specific eradication of wild polioviruses and sequential cessation of oral polio vaccine use.See paragraph 8 of the introductory notes.Tick-borne encephalitis.Hepatitis delta virus is pathogenic in workers only in the presence of simultaneous or secondary infection caused by hepatitis B virus. Vaccination against hepatitis B virus will therefore protect workers who are not affected by hepatitis B virus against hepatitis delta virus.Only for types A and B.Recommended for work involving direct contact with these agents.Two viruses are identified: one a buffalopox type and the other a variant of the Vaccinia virus.Variant of cowpox virus.Variant of Vaccinia.At present there is no evidence of disease in humans caused by the other retroviruses of simian origin. As a precaution containment level 3 is recommended for work with them.See paragraph 8 of the introductory notes.Recommended for work involving direct contact with these agents.See paragraph 8 of the introductory notes.
(3)Annex V to Directive 2000/54/EC is replaced by the following:"ANNEX VINDICATIONS CONCERNING CONTAINMENT MEASURES AND CONTAINMENT LEVELS(Articles 15(3) and 16(1)(a) and (b))Preliminary noteThe measures contained in this Annex shall be applied according to the nature of the activities, the assessment of risk to workers, and the nature of the biological agent concerned.In the table, "Recommended" means that the measures should in principle be applied, unless the results of the assessment referred to in Article 3(2) indicate otherwise.
HEPA: High efficiency particulate airAirlock: Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors.
A. Containment measuresB. Containment levels
234
Workplace
1. The workplace is to be separated from any other activities in the same buildingNoRecommendedYes
2. The workplace is to be sealable to permit fumigationNoRecommendedYes
Facilities
3. Infected material including any animal is to be handled in a safety cabinet or isolation or other suitable containmentWhere appropriateYes, where infection is by airborne routeYes
Equipment
4. Input air and extract air to the workplace are to be filtered using (HEPA) or likewiseNoYes, on extract airYes, on input and extract air
5. The workplace is to be maintained at an air pressure negative to atmosphereNoRecommendedYes
6. Surfaces impervious to water and easy to cleanYes, for bench and floorYes, for bench, floor and other surfaces determined by risk assessmentYes, for bench, walls, floor and ceiling
7. Surfaces resistant to acids, alkalis, solvents, disinfectantsRecommendedYesYes
System of work
8. Access is to be restricted to nominated workers onlyRecommendedYesYes, via airlock
9. Efficient vector control, for example rodents and insectsRecommendedYesYes
10. Specified disinfection proceduresYesYesYes
11. Safe storage of a biological agentYesYesYes, secure storage
12. Personnel should shower before leaving the contained areaNoRecommendedRecommended
Waste
13. Validated inactivation process for the safe disposal of animal carcasesRecommendedYes, on or off siteYes, on site
Other measures
14. A laboratory is to contain its own equipmentNoRecommendedYes
15. An observation window, or, alternative, is to be present, so that occupants can be seenRecommendedRecommendedYes"
----------------------
HEPA: High efficiency particulate airAirlock: Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors.
(4)Annex VI to Directive 2000/54/EC is replaced by the following:"ANNEX VICONTAINMENT FOR INDUSTRIAL PROCESSES(Article 4(1) and Article 16(2)(a))Preliminary noteIn the table, "Recommended" means that the measures should in principle be applied, unless the results of the assessment referred to in Article 3(2) indicate otherwise.Group 1 biological agentsFor work with group 1 biological agents including live attenuated vaccines, the principles of good occupational safety and hygiene should be observed.Groups 2, 3 and 4 biological agentsIt may be appropriate to select and combine containment requirements from different categories below on the basis of a risk assessment related to any particular process or part of a process.
HEPA: High efficiency particulate airClosed system: A system that physically separates the process from the environment (e.g. incubator vats, tanks, etc.).Airlock: Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors.
A. Containment measuresB. Containment levels
234
General
1. Viable organisms should be handled in a system which physically separates the process from the environmentYesYesYes
2. Exhaust gases from the closed system should be treated so as to:Minimise releasePrevent releasePrevent release
3. Sample collection, addition of materials to a closed system and transfer of viable organisms to another closed system, should be performed so as to:Minimise releasePrevent releasePrevent release
4. Bulk culture fluids should not be removed from the closed system unless the viable organisms have been:Inactivated by validated chemical or physical meansInactivated by validated chemical or physical meansInactivated by validated chemical or physical means
5. Seals should be designed so as to:Minimise releasePrevent releasePrevent release
6. The controlled area should be designed to contain spillage of the entire contents of the closed systemNoRecommendedYes
7. The controlled area should be sealable to permit fumigationNoRecommendedYes
Facilities
8. Decontamination and washing facilities should be provided for personnelYesYesYes
Equipment
9. Input air and extract air to the controlled area should be HEPA filteredNoRecommendedYes
10. The controlled area should be maintained at an air pressure negative to atmosphereNoRecommendedYes
11. The controlled area should be adequately ventilated to minimise air contaminationRecommendedRecommendedYes
System of work
12. Closed systems should be located within a controlled areaRecommendedRecommendedYes, and purpose-built
13. Biohazard signs should be postedRecommendedYesYes
14. Access should be restricted to nominated personnel onlyRecommendedYesYes, via an airlock
15. Personnel should shower before leaving the controlled areaNoRecommendedYes
16. Personnel should wear protective clothingYes, work clothingYesYes, complete change
Waste
17. Effluent from sinks and showers should be collected and inactivated before releaseNoRecommendedYes
18. Effluent treatment before final dischargeInactivated by validated chemical or physical meansInactivated by validated chemical or physical meansInactivated by validated chemical or physical means"
----------------------
HEPA: High efficiency particulate airClosed system: A system that physically separates the process from the environment (e.g. incubator vats, tanks, etc.).Airlock: Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors.