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

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 THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work OJ L 262, 17.10.2000, p. 21. , and in particular Article 19 thereof, Whereas: (1) Principle 10 of the European Pillar of Social Rights European Pillar of Social Rights, November 2017, https://ec.europa.eu/commission/priorities/deeper-and-fairer-economic-and-monetary-union/european-pillar-social-rights_en , proclaimed at Gothenburg on 17 November 2017, provides that every worker has the right to a healthy, safe and well-adapted working environment. The workers’ right to a high level of protection of their health and safety at work and to a working environment that is adapted to their professional needs and that enables them to prolong their participation in the labour market includes protection from exposure to biological agents at work. (2) The implementation of the directives related to the health and safety of workers at work, including Directive 2000/54/EC, was the subject of an ex-post evaluation, referred to as a REFIT evaluation. The evaluation looked at the directives’ relevance, at research and at new scientific knowledge in the various fields concerned. The REFIT evaluation, referred to in the Commission Staff Working Document SWD(2017) 10 final. , concludes, among other things, that the classified list of biological agents in Annex III to Directive 2000/54/EC needs to be amended in light of scientific and technical progress and that consistency with other relevant directives should be enhanced. (3) In its Communication Safer and Healthier Work for All — Modernisation of the EU Occupational Safety and Health Legislation and Policy COM(2017) 12. , the Commission reiterated that while the REFIT evaluation of the Union’s acquis on occupational health and safety confirmed that the legislation in this field is generally effective and fit-for-purpose, there is scope for updating outdated rules and ensuring better and broader protection, compliance and enforcement on the ground. The Commission emphasises the particular need to update the list of biological agents in Annex III to Directive 2000/54/EC. (4) Directive 2000/54/EC lays down rules to protect workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to biological agents at work. Directive 2000/54/EC applies to activities in which workers are exposed, or are potentially exposed, to biological agents as a result of their work, and states the measures to be taken in the case of any activity likely to involve a risk of exposure to biological agents, to determine the nature, degree and duration of workers’ exposure to biological agents.

(5) Since the results of a risk assessment can show an unintended exposure to biological agents, there could be other work activities not included in Annex I to Directive 2000/54/EC that should also be taken into consideration. Therefore, the indicative list of activities set out in Annex I to Directive 2000/54/EC should be amended to include an introductory phrase in order to clarify the non-exhaustive nature of the list. (6) Annex III to Directive 2000/54/EC sets out the list of biological agents known to infect humans, classified according to their level of risk of infection. In line with introductory note 6 in that Annex, the list should be amended to take into account the latest state of knowledge as regards scientific development that have brought about significant changes since the list was last updated, particularly as regards the taxonomy, nomenclature, classification and characteristics of biological agents, and the existence of new biological agents. (7) Annexes V and VI to Directive 2000/54/EC lay down the containment measures and levels for laboratories, animal facilities and industry. Annexes V and VI should be amended and restructured in order to be aligned with and to take into account the containment and other protective measures included in Directive 2009/41/EC of the European Parliament and of the Council Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (OJ L 125, 21.5.2009, p. 75). . (8) In preparing the current update of Annexes I, III V and VI to Directive 2000/54/EC, consideration was given to the need to maintain the existing levels of protection for workers who are or who are potentially exposed to biological agents through their work, and to ensure that the amendments only take into account scientific developments in the area, requiring adjustments at the workplace that are merely technical in nature. (9) The Advisory Committee for Safety and Health at Work was consulted on the measures resulting from the adoption of the Commission’s Communication Safer and Healthier Work for All — Modernisation of the EU Occupational Safety and Health Legislation and Policy that are required to keep the Union’s occupational health and safety legislation effective and fit-for-purpose. (10) In its Opinion on the Modernisation of Six OSH Directives to Ensure Healthier and Safer Work for All Advisory Committee for Safety and Health at Work Doc. 1718/2017. , adopted on 6 December 2017, the Advisory Committee for Safety and Health at Work recommends that Directive 2000/54/EC should be amended to enhance its relevance and effectiveness. (11) In a subsequent Opinion on technical updates to the annexes of the Biological Agents Directive (2000/54/EC) Advisory Committee for Safety and Health at Work Doc. 434/18. , adopted on 31 May 2018, the Advisory Committee for Safety and Health at Work recommends that specific updates should be made to Annex I, III, V and VI, reflecting the latest technological and scientific developments in the field.

(12) In preparing the current update of Annexes I, III, V and VI to Directive 2000/54/EC, the Commission was assisted by experts representing Member States, who provided technical and scientific support. (13) In accordance with the Joint Political Declaration on explanatory documents OJ C 369, 17.12.2011, p. 14. , adopted by the Member States and the Commission on 28 September 2011, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. (14) The measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 17 of Council Directive 89/391/EEC Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1). , HAS ADOPTED THIS DIRECTIVE:

Article 1

Annexes I, III, V and VI to Directive 2000/54/EC are replaced by the text in the Annex to this Directive.

Article 2

1. 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. They shall forthwith communicate to the Commission the text of those provisions. 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 3

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States. Done at Brussels, 24 October 2019. For the Commission The President Jean-Claude Juncker

Annex

ANNEX (1) Annex I to Directive 2000/54/EC is replaced by the following: . (2) Annex III to Directive 2000/54/EC is replaced by the following: (3) Annex V to Directive 2000/54/EC is replaced by the following: (4) Annex VI to Directive 2000/54/EC is replaced by the following:

Annex

ANNEX I INDICATIVE LIST OF ACTIVITIES (Article 4(2)) Preliminary note Where 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.

Article 2, second paragraph, and Article 18 INTRODUCTORY NOTES

1. 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 effects D: List of workers exposed to this biological agent to be kept for more than 10 years after the end of last known exposure T: Toxin production V: Effective vaccine available and registered within the EU The application of preventive vaccination should take account of the code of practice given in Annex VII. BACTERIA and similar organisms NB: 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 agentClassificationNotesActinomadura maduraeWActinomadura pelletieri2Actinomyces gerencseriae2Actinomyces israelii2Actinomyces spp.2Aggregatibacter actinomycetemcomitans (Actinobacillus actinomycetemcomitans)2Anaplasma spp.2Arcanobacterium haemolyticum (Corynebacterium haenolyticum)2Arcobacter butzleri2Bacillus anthracis3TBacteroides fragilis2Bacteroides spp.2Bartonella bacilliformis2Bartonella quintana (Rochalimaea quintana)2Bartonella (Rochalimaea) spp.2Bordetella bronchiseptica2Bordetella parapertussis2Bordetella pertussis2T, VBordetella spp.2Borrelia burgdorferi2Borrelia duttonii2Borrelia recurrentis2Borrelia spp.2Brachyspira spp.2Brucella abortus3Brucella canis3Brucella inopinata3Brucella melitensis3Brucella suis3Burkholderia cepacia2Burkholderia mallei (Pseudomonas mallei)3Burkholderia pseudomallei (Pseudomonas pseudomallei)3D Campylobacter fetus subsp. fetus2Campylobacter fetus subsp. venerealis2Campylobacter jejuni subsp. doylei2Campylobacter jejuni subsp. jejuni2Campylobacter spp.2Cardiobacterium hominis2Cardiobacterium valvarum2Chlamydia abortus (Chlamydophila abortus)2Chlamydia caviae (Chlamydophila caviae)2Chlamydia felis (Chlamydophila felis)2Chlamydia pneumoniae (Chlamydophila pneumoniae)2Chlamydia psittaci (Chlamydophila psittaci) (avian strains)3Chlamydia psittaci (Chlamydophila psittaci) (other strains)2Chlamydia trachomatis (Chlamydophila trachomatis)2Clostridium botulinum2TClostridium difficile2TClostridium perfringens2TClostridium tetani2T, VClostridium spp.2Corynebacterium diphtheriae2T, VCorynebacterium minutissimum2Corynebacterium pseudotuberculosis2TCorynebacterium ulcerans2TCorynebacterium spp.2Coxiella burnetii3Edwardsiella tarda2Ehrlichia spp.2Eikenella corrodens2Elizabethkingia meningoseptica (Flavobacterium meningosepticum)2Enterobacter aerogenes (Klebsiella mobilis)2Enterobacter cloacae subsp. cloacae (Enterobacter cloacae)2Enterobacter spp.2Enterococcus spp.2Erysipelothrix rhusiopathiae2Escherichia coli (with the exception of non-pathogenic strains)2Escherichia coli, verocytotoxigenic strains (e.g. O157:H7 or O103)3TFluoribacter bozemanae (Legionella)2Francisella hispaniensis2

Francisella tularensis subsp. holarctica2Francisella tularensis subsp. mediasiatica2Francisella tularensis subsp. novicida2Francisella tularensis subsp. tularensis3Fusobacterium necrophorum subsp. funduliforme2Fusobacterium necrophorum subsp. necrophorum2Gardnerella vaginalis2Haemophilus ducreyi2Haemophilus influenzae2VHaemophilus spp.2Helicobacter pylori2Helicobacter spp.2Klebsiella oxytoca2Klebsiella pneumoniae subsp. ozaenae2Klebsiella pneumoniae subsp. pneumoniae2Klebsiella pneumoniae subsp. rhinoscleromatis2Klebsiella spp.2Legionella pneumophila subsp. fraseri2Legionella pneumophila subsp. pascullei2Legionella pneumophila subsp. pneumophila2Legionella spp.2Leptospira interrogans (all serovars)2Leptospira interrogans spp.2Listeria monocytogenes2Listeria ivanovii subsp. ivanovii2Listeria invanovii subsp. londoniensis2Morganella morganii subsp. morganii (Proteus morganii)2Morganella morganii subsp. sibonii2Mycobacterium abscessus subsp. abscessus2Mycobacterium africanum3VMycobacterium avium subsp. avium (Mycobacterium avium)2Mycobacterium avium subsp. paratuberculosis (Mycobacterium paratuberculosis)2Mycobacterium avium subsp. silvaticum2Mycobacterium bovis3VMycobacterium caprae (Mycobacterium tuberculosis subsp. caprae)3Mycobacterium chelonae2Mycobacterium chimaera2Mycobacterium fortuitum2 Mycobacterium intracellulare2Mycobacterium kansasii2Mycobacterium leprae3Mycobacterium malmoense2Mycobacterium marinum2Mycobacterium microti3Mycobacterium pinnipedii3Mycobacterium scrofulaceum2Mycobacterium simiae2Mycobacterium szulgai2Mycobacterium tuberculosis3VMycobacterium ulcerans3Mycobacterium xenopi2Mycoplasma hominis2Mycoplasma pneumoniae2Mycoplasma spp.2Neisseria gonorrhoeae2Neisseria meningitidis2VNeorickettsia sennetsu (Rickettsia sennetsu, Ehrlichia sennetsu)2Nocardia asteroides2Nocardia brasiliensis2Nocardia farcinica2Nocardia nova2Nocardia otitidiscaviarum2Nocardia spp.2Orientia tsutsugamushi (Rickettsia tsutsugamushi)3Pasteurella multocida subsp. gallicida (Pasteurella gallicida)2Pasteurella multocida subsp. multocida2Pasteurella multocida subsp. septica2Pasteurella spp.2Peptostreptococcus anaerobius2Plesiomonas shigelloides2Porphyromonas spp.2Prevotella spp.2Proteus mirabilis2Proteus penneri2Proteus vulgaris2Providencia alcalifaciens (Proteus inconstans)2 Providencia rettgeri (Proteus rettgeri)2Providencia spp.2Pseudomonas aeruginosa2TRhodococcus hoagii (Corynebacterium equii)2Rickettsia africae3Rickettsia akari3Rickettsia australis3Rickettsia canadensis2Rickettsia conorii3Rickettsia heilongjiangensis3Rickettsia japonica3Rickettsia montanensis2Rickettsia typhi3Rickettsia prowazekii3Rickettsia rickettsii3Rickettsia sibirica3Rickettsia spp.2Salmonella enterica (choleraesuis) subsp. arizonae2Salmonella Enteritidis2Salmonella Paratyphi A, B, C2VSalmonella Typhi3VSalmonella Typhimurium2Salmonella (other serovars)2Shigella boydii2Shigella dysenteriae (Type 1)3TShigella dysenteriae, other than Type 12Shigella flexneri2Shigella sonnei2Staphylococcus aureus2TStreptobacillus moniliformis2Streptococcus agalactiae2Streptococcus dysgalactiae subsp. equisimilis2Streptococcus pneumoniae2T, VStreptococcus pyogenes2TStreptococcus suis2Streptococcus spp.2Treponema carateum2Treponema pallidum2

Treponema pertenue2Treponema spp.2Trueperella pyogenes2Ureaplasma parvum2Ureaplasma urealyticum2Vibrio cholerae (including El Tor)2T, VVibrio parahaemolyticus (Benecka parahaemolytica)2Vibrio spp.2Yersinia enterocolitica subsp. enterolitica2Yersinia enterocolitica subsp. palearctica2Yersinia pestis3Yersinia pseudotuberculosis2Yersinia 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) ClassificationNotesBunyavirales (O)Hantaviridae (F)Orthohantavirus (G)Andes orthohantavirus (Hantavirus species causing Hantavirus Pulmonary Syndrome [HPS])3Bayou orthohantavirus3Black Creek Canal orthohantavirus3Cano Delgadito orthohantavirus3Choclo orthohantavirus3Dobrava-Belgrade orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS])3El Moro Canyon orthohantavirus3Hantaan orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS])3Laguna Negra orthohantavirus3Prospect Hill orthohantavirus2Puumala orthohantavirus (Hantavirus species causing Nephropathia Epidemica [NE])2 Seoul orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS])3Sin Nombre orthohantavirus (Hantavirus species causing Hantavirus Pulmonary Syndrome [HPS])3Other hantaviruses known to be pathogenic2Nairoviridae (F)Orthonairovirus (G)Crimean-Congo haemorrhagic fever orthonairovirus4Dugbe orthonairovirus2Hazara orthonairovirus2Nairobi sheep disease orthonairovirus2Other nairoviruses known to be pathogenic2Peribunyaviridae (F)Orthobunyavirus (G)Bunyamwera orthobunyavirus (Germiston virus)2California encephalitis orthobunyavirus2Oropouche orthobunyavirus3Other orthobunyaviruses known to be pathogenic2Phenuiviridae (F)Phlebovirus (G)Bhanja phlebovirus2Punta Toro phlebovirus2Rift Valley fever phlebovirus3Sandfly fever Naples phlebovirus (Toscana Virus)2SFTS phlebovirus (Severe Fever with Thrombocytopenia Syndrome-Virus)3Other phleboviruses known to be pathogenic2Herpesvirales (O)Herpesviridae (F)Cytomegalovirus (G)Human betaherpesvirus 5 (Cytomegalovirus)2Lymphocryptovirus (G)Human gammaherpesvirus 4 (Epstein-Barr virus)2Rhadinoovirus (G)Human gammaherpesvirus 82DRoseolovirus (G)Human betaherpesvirus 6A (Human B-lymphotropic virus)2Human betaherpesvirus 6B2Human betaherpesvirus 72

Simplexvirus (G)Macacine alphaherpesvirus 1 (Herpesvirus simiae, Herpes B virus)3Human alphaherpesvirus 1 (Human herpesvirus 1, Herpes simplex virus type 1)2Human alphaherpesvirus 2 (Human herpesvirus 2, Herpes simplex virus type 2)2Varicellovirus (G)Human alphaherpesvirus 3 (Herpesvirus varicella-zoster)2VMononegavirales (O)Filoviridae (F)Ebolavirus (G)4Marburgvirus (G)Marburg marburgvirus4Paramyxoviridae (F)Avulavirus (G)Newcastle disease virus2Henipavirus (G)Hendra henipavirus4Nipah henipavirus4Morbillivirus (G)Measles morbillivirus2VRespirovirus (G)Human respirovirus 1 (Parainfluenza virus 1)2Human respirovirus 3 (Parainfluenza virus 3)2Rubulavirus (G)Mumps rubulavirus2VHuman rubulavirus 2 (Parainfluenza virus 2)2Human rubulavirus 4 (Parainfluenza virus 4)2Pneumoviridae (F)Metapneumovirus (G)Orthopneumovirus (G)Human orthopneumovirus (Respiratory syncytial virus)2Rhabdoviridae (F)Lyssavirus (G)Australian bat lyssavirus3VDuvenhage lyssavirus3VEuropean bat lyssavirus 13VEuropean bat lyssavirus 23V Lagos bat lyssavirus3Mokola lyssavirus3Rabies lyssavirus3VVesiculovirus (G)Vesicular stomatitis virus, Alagoas vesiculovirus2Vesicular stomatitis virus, Indiana vesiculovirus2Vesicular stomatitis virus, New Jersey vesiculovirus2Piry vesiculovirus (Piry virus)2Nidovirales (O)Coronaviridae (F)Betacoronavirus (G)Severe acute respiratory syndrome-related coronavirus (SARS-virus)3Middle East respiratory syndrome coronavirus (MERS-virus)3Other Coronaviridae known to be pathogenic2Picornavirales (O)Picornaviridae (F)Cardiovirus (G)Saffold virus2Cosavirus (G)Cosavirus A2Enterovirus (G)Enterovirus A2Enterovirus B2Enterovirus C2Enterovirus D, Human Enterovirus type 70 (Acute haemorrhagic conjunctivitis virus)2Rhinoviruses2Poliovirus, type 1 and 32VPoliovirus, type 2 3VHepatovirus (G)Hepatovirus A (Hepatitis A virus, Human Enterovirus type 72)2VKobuvirus (G)Aichivirus A (Aichi virus 1)2Parechovirus (G)Parechoviruses A2Parechoviruses B (Ljungan virus)2Other Picornaviridae known to be pathogenic2 Unassigned (O)Adenoviridae (F)2Astroviridae (F)2Arenaviridae (F)Mammarenavirus (G)Brazilian mammarenavirus4Chapare mammarenavirus4Flexal mammarenavirus3Guanarito mammarenavirus4Junín mammarenavirus4Lassa mammarenavirus4Lujo mammarenavirus4Lymphocytic choriomeningitis mammarenavirus, neurotropic strains2Lymphocytic choriomeningitis mammarenavirus (other strains)2Machupo mammarenavirus4Mobala mammarenavirus2Mopeia mammarenavirus2Tacaribe mammarenavirus2Whitewater Arroyo mammarenavirus3Caliciviridae (F)Norovirus (G)Norovirus (Norwalk virus)2Other Caliciviridae known to be pathogenic2Hepadnaviridae (F)Orthohepadnavirus (G)Hepatitis B virus3V, DHepeviridae (F)Orthohepevirus (G)Orthohepevirus A (Hepatitis E virus)2Flaviviridae (F)Flavivirus (G)Dengue virus3Japanese encephalitis virus3VKyasanur Forest disease virus3VLouping ill virus3Murray Valley encephalitis virus (Australia encephalitis virus)3 Omsk haemorrhagic fever virus3Powassan virus3Rocio virus3St. Louis encephalitis virus3Tick-borne encephalitis virusAbsettarov virus3Hanzalova virus3Hypr virus3Kumlinge virus3Negishi virus3Russian spring-summer encephalitis3VTick-borne encephalitis virus Central European subtype3VTick-borne encephalitis virus Far Eastern Subtype3Tick-borne encephalitis virus Siberian subtype3VWesselsbron virus3West Nile fever virus3Yellow fever virus3VZika virus2Other flaviviruses known to be pathogenic2Hepacivirus (G)Hepacivirus C (Hepatitis C virus)3DOrthomyxoviridae (F)Gammainfluenzavirus (G)Influenza C virus2VInfluenzavirus A (G)Highly Pathogenic Avian Influenza Viruses HPAIV (H5), e.g. H5N13Highly Pathogenic Avian Influenza Viruses HPAIV (H7), e.g. H7N7, H7N93Influenza A virus2VInfluenza A virus A/New York/1/18 (H1N1) (Spanish flu 1918)3Influenza A virus A/Singapore/1/57 (H2N2)3Low Pathogenic Avian Influenza Virus (LPAI) H7N93Influenzavirus B (G)Influenza B virus2VThogoto virus (G)Dhori virus (Tick-borne orthomyxoviridae: Dhori)2Thogoto virus (Tick-borne orthomyxoviridae: Thogoto)2

Papillomaviridae (F)2DParvoviridae (F)Erythroparvovirus (G)Primate erythroparvovirus 1 (Human parvovirus, B 19 virus)2Polyomaviridae (F)Betapolyomavirus (G)Human polyomavirus 1 (BK virus)2DHuman polyomavirus 2 (JC virus)2DPoxviridae (F)Molluscipoxvirus (G)Molluscum contagiosum virus2Orthopoxvirus (G)Cowpox virus2Monkeypox virus3VVaccinia virus (incl. Buffalopox virus , Elephantpox virus , Rabbitpox virus )2Variola (major and minor) virus4VParapoxvirus (G)Orf virus2Pseudocowpox virus (Milkers’ node virus, parapoxvirus bovis)2Yatapoxvirus (G)Tanapox virus2Yaba monkey tumor virus2Reoviridae (F)Seadornavirus (G)Banna virus2Coltivirus (G)2Rotaviruses (G)2Orbivirus (G)2Retroviridae (F)Deltaretrovirus (G)Primate T-lymphotropic virus 1 (Human T-cell lymphotropic virus, type 1)3DPrimate T-lymphotropic virus 2 (Human T-cell lymphotropic virus, type 2)3DLentivirus (G)Human immunodeficiency virus 13DHuman immunodeficiency virus 23DSimian Immunodeficiency Virus (SIV)2 Togaviridae (F)Alphavirus (G)Cabassouvirus3Eastern equine encephalomyelitis virus3VBebaru virus2Chikungunya virus3Everglades virus3Mayaro virus3Mucambo virus3Ndumu virus3O’nyong-nyong virus2Ross River virus2Semliki Forest virus2Sindbis virus2Tonate virus3Venezuelan equine encephalomyelitis virus3VWestern equine encephalomyelitis virus3VOther alphaviruses known to be pathogenic2Rubivirus (G)Rubella virus2VUnassigned (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 agentClassificationNotesAgent of Creutzfeldt-Jakob disease3DVariant Agent of Creutzfeldt-Jakob disease3DAgent of Bovine Spongiform Encephalopathy (BSE) and other related animal TSEs3DAgent of Gerstmann-Sträussler-Scheinker syndrome3DAgent of Kuru3DAgent of Scrapie2 PARASITES NB: 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 agentClassificationNotesAcanthamoeba castellani2Ancylostoma duodenale2Angiostrongylus cantonensis2Angiostrongylus costaricensis2Anisakis simplex2AAscaris lumbricoides2AAscaris suum2ABabesia divergens2Babesia microti2Balamuthia mandrillaris3Balantidium coli2Brugia malayi2Brugia pahangi2Brugia timori2Capillaria philippinensis2Capillaria spp.2Clonorchis sinensis (Opisthorchis sinensis)2Clonorchis viverrini (Opisthirchis viverrini)2Cryptosporidium hominis2Cryptosporidium parvum2Cyclospora cayetanensis2Dicrocoelium dentriticum2 Dipetalonema streptocerca2Diphyllobothrium latum2Dracunculus medinensis2Echinococcus granulosus3Echinococcus multilocularis3Echinococcus oligarthrus3Echinococcus vogeli3Entamoeba histolytica2Enterobius vermicularis2Enterocytozoon bieneusi2Fasciola gigantica2Fasciola hepatica2Fasciolopsis buski2Giardia lamblia (Giardia duodenalis, Giardia intestinalis)2Heterophyes spp.2Hymenolepis diminuta2Hymenolepis nana2Leishmania aethiopica2Leishmania braziliensis3Leishmania donovani3Leishmania guyanensis (Viannia guyanensis)3Leishmania infantum (Leishmania chagasi)3Leishmania major2Leishmania mexicana2Leishmania panamensis (Viannia panamensis)3Leishmania peruviana2Leishmania tropica2Leishmania spp.2Loa loa2Mansonella ozzardi2Mansonella perstans2Mansonella streptocerca2Metagonimus spp.2Naegleria fowleri3Necator americanus2Onchocerca volvulus2Opisthorchis felineus2

Opisthorchis spp.2Paragonimus westermani2Paragonimus spp.2Plasmodium falciparum3Plasmodium knowlesi3Plasmodium spp. (human and simian)2Sarcocystis suihominis2Schistosoma haematobium2Schistosoma intercalatum2Schistosoma japonicum2Schistosoma mansoni2Schistosoma mekongi2Strongyloides stercoralis2Strongyloides spp.2Taenia saginata2Taenia solium3Toxocara canis2Toxocara cati2Toxoplasma gondii2Trichinella nativa2Trichinella nelsoni2Trichinella pseudospiralis2Trichinella spiralis2Trichomonas vaginalis2Trichostrongylus orientalis2Trichostrongylus spp.2Trichuris trichiura2Trypanosoma brucei brucei2Trypanosoma brucei gambiense2Trypanosoma brucei rhodesiense3Trypanosoma cruzi3Wuchereria bancrofti2 FUNGI NB: 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 agentClassificationNotesAspergillus flavus2AAspergillus fumigatus2AAspergillus spp.2Blastomyces dermatitidis (Ajellomyces dermatitidis)3Blastomyces gilchristii3Candida albicans2ACandida dubliniensis2Candida glabrata2Candida parapsilosis2Candida tropicalis2Cladophialophora bantiana (Xylohypha bantiana, Cladosporium bantianum,trichoides)3Cladophialophora modesta3Cladophialophora spp.2Coccidioides immitis3ACoccidioides posadasii3ACryptococcus gattii (Filobasidiella neoformans var. bacillispora)2ACryptococcus neoformans (Filobasidiella neoformans var. neoformans)2AEmmonsia parva var. parva2Emmonsia parva var. crescens2Epidermophyton floccosum2AEpidermophyton spp.2Fonsecaea pedrosoi2Histoplasma capsulatum3Histoplasma capsulatum var. farciminosum3Histoplasma duboisii3Madurella grisea2Madurella mycetomatis2Microsporum spp.2ANannizzia spp.2Neotestudina rosatii2Paracoccidioides brasiliensis3AParacoccidioides lutzii3Paraphyton spp.2Rhinocladiella mackenziei3 Scedosporium apiospermum2Scedosporium prolificans (inflatum)2Sporothrix schenckii2Talaromyces marneffei (Penicillium marneffei)2ATrichophyton rubrum2ATrichophyton tonsurans2ATrichophyton spp.2

Annex

ANNEX V INDICATIONS CONCERNING CONTAINMENT MEASURES AND CONTAINMENT LEVELS (Articles 15(3) and 16(1)(a) and (b)) Preliminary note The 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 air 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 levels234Workplace1. The workplace is to be separated from any other activities in the same buildingNoRecommendedYes2. The workplace is to be sealable to permit fumigationNoRecommendedYesFacilities3. 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 routeYesEquipment4. Input air and extract air to the workplace are to be filtered using (HEPA) or likewiseNoYes, on extract airYes, on input and extract air5. The workplace is to be maintained at an air pressure negative to atmosphereNoRecommendedYes6. 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

1. Surfaces resistant to acids, alkalis, solvents, disinfectantsRecommendedYesYesSystem of work8. Access is to be restricted to nominated workers onlyRecommendedYesYes, via airlock9. Efficient vector control, for example rodents and insectsRecommendedYesYes10. Specified disinfection proceduresYesYesYes11. Safe storage of a biological agentYesYesYes, secure storage12. Personnel should shower before leaving the contained areaNoRecommendedRecommendedWaste13. Validated inactivation process for the safe disposal of animal carcasesRecommendedYes, on or off siteYes, on siteOther measures14. A laboratory is to contain its own equipmentNoRecommendedYes15. An observation window, or, alternative, is to be present, so that occupants can be seenRecommendedRecommendedYes

Annex

ANNEX VI CONTAINMENT FOR INDUSTRIAL PROCESSES (Article 4(1) and Article 16(2)(a)) Preliminary note 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. Group 1 biological agents For 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 agents It 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 air Closed 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 levels234General1. Viable organisms should be handled in a system which physically separates the process from the environmentYesYesYes2. Exhaust gases from the closed system should be treated so as to:Minimise releasePrevent releasePrevent release3. 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 release4. 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 means5. Seals should be designed so as to:Minimise releasePrevent releasePrevent release6. The controlled area should be designed to contain spillage of the entire contents of the closed systemNoRecommendedYes7. The controlled area should be sealable to permit fumigationNoRecommendedYesFacilities8. Decontamination and washing facilities should be provided for personnelYesYesYesEquipment9. Input air and extract air to the controlled area should be HEPA filteredNoRecommendedYes10. The controlled area should be maintained at an air pressure negative to atmosphereNoRecommendedYes11. The controlled area should be adequately ventilated to minimise air contaminationRecommendedRecommendedYesSystem of work12. Closed systems should be located within a controlled areaRecommendedRecommendedYes, and purpose-built13. Biohazard signs should be postedRecommendedYesYes14. Access should be restricted to nominated personnel onlyRecommendedYesYes, via an airlock