CELEX: 51992PC0261
Language: en
Date: 1992-07-15
Title: Proposal for a COUNCIL DIRECTIVE amending Directive 90/679/CEE on the protection of workers from risks related to exposure to biological agents at work

No C 217 / 32                                 Official Journal of the European Communities                                        24 . 8 . 92
              Proposal for a Council Directive amending Directive 90 / 679 / EEC on the protection of workers from
                                          risks related to exposure to biological agents at work
                                                              ( 92 / C 217 / 03 )
                                                      COM(92) 261 final — SYN 421
                                             (Submitted by the Commission on 15 July 1992 )
THE COUNCIL OF THE EUROPEAN COMMUNITIES                                    Whereas the first list of biological agents should contain
                                                                           separate information on the abovementioned properties in
                                                                           order to provide better protection for workers ,
Having regard to the Treaty establishing the European
Economic Community , and in particular Article 118a
thereof,
                                                                           HAS ADOPTED THIS DIRECTIVE :
Having regard to the proposal from the Commission , drawn
up after consulting the Advisory Committee on Safety ,                                                Article 1
Hygiene and Health Protection at Work ,
                                                                           Directive 90 / 679 / EEC shall be amended as follows :
In cooperation with the European Parliament ,
                                                                               Annex III shall be supplemented by a first list of
                                                                               Groups 2 , 3 and 4 biological agents as given in the Annex
Having regard to the opinion of the Economic and Social                        to this Directive .
Committee ,
                                                                                                       Article 2
Whereas Article 18       of Directive 90 / 679 / EEC on the
protection of workers from risks related to exposure to
biological agents at work ( ! ) states that , in accordance with           1.     Member States shall bring into force the laws ,
the procedure laid down in Article 118a of the Treaty , the                regulations and administrative provisions necessary to
Council must adopt a first list of group 2 , group 3 and                   comply with this Directive not later than 3 0 April 1994 . They
                                                                           shall forthwith inform the Commission thereof.
group 4 biological agents for Annex III to that Directive ;
                                                                           2.     Member States shall communicate to the Commission
Whereas this first list of biological agents must be classified            the provisions of national law already adopted or which they
on the basis of the definitions given in Article 2(d ) points 2 , 3        adopt in the field governed by this Directive .
and 4 ( groups 2 , 3 and 4 ) of the Directive ;
                                                                           3.     Such provisions adopted by the Member States shall
                                                                           contain a reference to this Directive , or shall be accompanied
Whereas , for certain of these biological agents , it is                   by such a reference upon official publication . The Member
appropriate to keep lists of exposed workers for more than                 States shall decide how such reference is made .
10 years after their last exposure to the said biological
agents ;
                                                                                                       Article 3
Whereas other biological agents are likely to cause allergic or
toxic reactions ;                                                          This Directive is addresed to the Member States .
(') OJ No L 374 , 31 . 12 . 1990 , p. 1 .
 ---pagebreak--- 24 . 8 . 92                                  Official Journal of the European Communities                                          No C 217 / 33
                                                                    ANNEX
                                                                   ANNEX 111
                                                               Introductory notes
            1 . In line with the scope of Directive 90 / 679 / EEC only agents which are known to infect humans are to be
                included . Where appropriate , indicators are given of the toxic and allergenic potential of these agents . Animal
                and plant pathogens which are known not to affect man are excluded . In drawing up this first list of classified
                biological agents consideration has not been given to genetically-modified microorganisms .
            2 . The list of classified biological agents is based on the effect of these agents on healthy workers . No specific
                account is taken of particular effects on those whose susceptibility may be affected for one or other reasons
                such as pre-existing disease , medication , compromised immunity , pregnancy or breastfeeding . Additional risk
                to such workers should be considered as part of the risk assessment required by Council
                Directive 90 / 679 / EEC . In industrial processes , laboratory work or work with animals involving actual or
                potential exposure to biological agents of Groups 3 or 4 , any technical precautions taken must conform to
                Article 16 ( c ) of Council Directive 90 / 679 / EEC .
            3 . Biological agents which have not been classified for inclusion in Group 2 to 4 in the list , are therefore not
                implicitly classified in Group 1 . For agents where there are more than one species known to be pathogenic to
                man , the list of classified biological agents may include the whole genus of a biological agent , together with
                individual entries for those species which are known to be the most important in terms of human infectivity ,
                allergy and toxicity or are more frequently encountered . 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 , ( e.g. when such a strain is to be used as a product or part of product for prophylactic / therapeutic
                purposes ).
            5 . The nomenclature of classified agents used to establish this list reflects and is in conformity with the latest
                international agreements on the taxonomy and nomenclature of agents at the time the list was prepared .
            6 . This list of classified biological agents reflects the state of knowledge at the time that it was devised .
            7 . All viruses which have already been isolated in humans and which are not allocated in a group in the list are to
                be classified in Group 2 as a minimum ( specific measures for these agents have to be taken according to
                Directive 90 / 679 / EEC ).
            8 . The classification of parasites and the resulting requirements as to containment apply only to stages in the life
                cycle of the parasite in which it is liable to be infectious to humans at the workplace.
            9 . This list also gives a special indication in cases where the biological agents are likely to cause toxic or allergic
                reactions , where preventive vaccination 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 last known
                     exposure .
                T : Toxin production .
                V:   Vaccination recommended .
 ---pagebreak--- No C 217 / 34                                   Official Journal of the European Communities                 24 . 8 . 92
                                                Biological agent                      Classification   Notes
            BACTERIA AND SIMILAR
            Actinomadura madurae                                                            2
            Actinomadura pelletieri                                                         2
            Actinomyces gerencseriae                                                        2
            Actinomyces israelii                                                            2
            Actinomyces pyogenes                                                            2
            Actinomyces spp . (*)                                                           2
            Arcanobacterium haemolyticum ( corynebacterium haemolyticum )                   2
            Bacillus anthracis                                                              3
            Bacteroides fragilis                                                            2
            Bartonella bacilliformis                                                        2        I
            Bordetella bronchiseptica                                                       2
            Bordetella parapertussis                                                        2
            Bordetella pertussis                                                            2
            Borrelia burgdorferi                                                            2
            Borrelia duttonii                                                               2
            Borrelia recurrentis                                                            2
            Borrelia spp . (*)                                                              2
            Brucella abortus                                                                3
            Brucella canis                                                                  3
            Brucella melitensis                                                             3
            Brucella suis                                                                   3
            Campylobacter fetus                                                             2
            Campylobacter jejuni                                                            2
            Campylobacter spp . (*)                                                         2
            Cardiobacterium hominis                                                         2
            Chlamydia pneumoniae                                                            2
            Chlamydia trachomatis                                                           2
            Chlamydia psittaci ( avian strains )                                            3
            Chlamydia psittaci ( other strains )                                            2
            Clostridium botulinum                                                           2           T
            Clostridium perfringens                                                         2
            Clostridium tetani                                                              2          T, V
            Clostridium spp . ( * )                                                         2
            Corynebacterium diphtheriae                                                     2          T, v
            Corynebacterium minutissimum                                                    2
            Corynebacterium pseudotuberculosis                                              2
            Corynebacterium spp . (*)                                                       2
            Coxiella burnetii                                                               3
            Edwardsiella tarda                                                              2
            Ehrlichia sennetsu ( Rickettsia sennetsu )                                      2
            Ehrlichia spp . (*)                                                             2
            (*) 'spp .' refers to other species which are known pathogens in humans .
 ---pagebreak--- 24 . 8 . 92                                     Official Journal of the European Communities               No C 217 / 35
                                                Biological agent                      Classification Notes
            Eikenella corrodens                                                             2
            Enterobacter aerogenes                                                          2
            Enterococcus spp . (*)                                                          2
            Erysipelothrix rhusiopathiae                                                    2
            Escherichia coli                                                                2
            Flavobacterium meningosepticum                                                  2
            Fluoribacter bozemanae ( Legionella )                                           2
            Francisella tularensis ( Type A )                                               3
            Francisella tularensis ( Type B )                                               2
            Gardnerella vaginalis                                                           2
            Haemophilus actinomycetem comitans (Actinobacillus )                            2
            Haemophilus ducreyi                                                             2
            Haemophilus influenzae                                                          2
            Haemophilus spp . (*)                                                           2
            Helicobacter pylori                                                             2
            Klebsiella oxytoca                                                              2
            Klebsiella pneumoniae                                                           2
            Klebsiella spp . ( )                                                            2
            Legionella pneumophila                                                          2
            Legionella spp . (*)                                                            2
            Leptospira interrogans ( all serovars )                                         2
            Listeria monocytogenes                                                          2
            Listeria ivanovii                                                               2
            Morganella morganii                                                             2
            Mycobacterium africanum                                                         3         V
            Mycobacterium avium intracellulare                                              2
            Mycobacterium bovis ( excluding BCG Strain )                                    3         v
            Mycobacterium chelonae                                                          2
            Mycobacterium fortuitum                                                         2
            Mycobacterium kansasii                                                          2
            Mycobacterium leprae                                                            3
            Mycobacterium malmoense                                                         2
            Mycobacterium marinum                                                           2
            Mycobacterium microti                                                           3
            Mycobacterium paratuberculosis                                                  2
            Mycobacterium scrofulaceum                                                      2
            Mycobacterium simiae                                                            2
            Mycobacterium szulgai                                                           2
            Mycobacterium tuberculosis                                                      3         v
            Mycobacterium ulcerans                                                          3
            Mycobacterium xenopi                                                            2
            Mycoplasma pneumoniae                                                           2
            (*) 'sop .' refers to other species which are known pathogens in humans .
 ---pagebreak--- No C 217 / 36                                   Official Journal of the European Communities               24 . 8 . 92
                                                Biological agent                      Classification Notes
            Neisseria gonorrhoeae                                                           2
            Neisseria meningitidis                                                          2
            Nocardia asteroides                                                             2
            Nocardia brasiliensis                                                           2
            Nocardia farcinica                                                              2
            Nocardia nova                                                                   2
            Nocardia otitidis-caviarum                                                      2
            Pasteurella multocida                                                           2
            Pasteurella spp . (*)                                                           2
            Plesiomonas shigelloides                                                        2
            Proteus mirabilis                                                               2
            Proteus penneri                                                                 2
            Proteus vulgaris                                                                2
            Providencia alcalifaciens                                                       2
            Providencia rettgeri                                                            2
            Providencia spp . (*)                                                           2
            Pseudomonas aeruginosa                                                          2
            Pseudomonas mallei                                                              3
            Pseudomonas pseudomallei                                                        3
            Rhodococcus equi                                                                2
            Rickettsia akari                                                                3
            Rickettsia canada                                                               3
            Rickettsia conorii                                                              3
            Rickettsia montana                                                              3
            Rickettsia typhi ( Mooseri )                                                    3
            Rickettsia prowazekii                                                           3
            Rickettsia rickettsii                                                           3
            Rickettsia tsutsugamushi                                                        3
            Rochalimaea quintana                                                            2
            Salmonella arizonae                                                             2
            Salmonella enteritidis                                                          2
            Salmonella typhimurium                                                          2
            Salmonella paratyphi A , B , C                                                  3         V
            Salmonella typhi                                                                3         V
            Salmonella ( other Serovars )                                                   2
            Shigella boydii                                                                 2
            Shigella dysenteriae ( Type 1 )                                                 3         T
            Shigella flexneri                                                               2
            Shigella sonnet                                                                 2
            Staphylococcus aureus                                                           2
            Streptobacillus moniliformis                                                    2
            Streptococcus pneumoniae                                                        2
            (*) 'spp .' refers to other species which are known pathogens in humans .
 ---pagebreak--- 24 . 8 . 92                                     Official Journal of the European Communities                No C 217 / 37
                                                Biological agent                       Classification Notes
            Streptococcus pyogenes                                                           2
            Streptococcus spp . (*)                                                          2
            Treponema carateum                                                               2
            Treponema pallidum                                                               2
            Treponema pertenue                                                               2
            Treponema spp . (*)                                                              2
             Vibrio cholerae ( including El Tor )                                            2
            Vibrio parahaemolyticus                                                          2
             Vibrio spp . (*)                                                                2
            Yersinia enterocolitica                                                          2
            Yersinia pestis                                                                  3
            Yersinia pseudotuberculosis                                                      2
            Yersinia spp . (*')                                                              2
            VIRUSES (**)
            Adenoviridae                                                                     2
            Arenaviridae
               Junin Virus                                                                   4
               Lassa fever virus                                                             4
               Lymphocytic choriomeningitis virus ( neurotropic strains )                    3
               Lymphocytic choriomeningitis virus ( other strains )                          2
               Machupo virus                                                                 4
               Mopeia virus and other Tacaribe viruses                                       2
            Astroviridae                                                                     2
            Bunyaviridae
               Bunyamwera viruses :
                  Bunyamwera virus                                                           2
                  Oropouche virus                                                            3
                 California encephalitis virus                                               2
               Hantaviruses :
                 Hantaan ( Korean haemorrhagic fever )                                       3
                  Other hantaviruses                                                         3
               Nairoviruses :
                 Congo / Crimean haemorrhagic fever                                          4
                 Hazara virus                                                                2
               Phleboviruses :
                  Rift Valley fever                                                          3         V
                 Sandfly fever virus                                                         2
                  Toscana virus                                                              2
               Other Bunyaviridae known to be pathogenic                                     2
            Caliciviridae                                                                    2
            Coronaviridae                                                                    2
             (*) 4spp .' refers to other species which are known pathogens in humans .
            (**) See Indroductory Note No 7 .
 ---pagebreak--- No C 217 / 38                                     Official Journal of the European Communities                                                   24 . 8 . 92
                                                  Biological agent                                      Classification            Notes
            Filoviridae
                 Ebola virus                                                                                  4
                 Marburg virus                                                                                4
            Flaviviridae :
                    Australia encephalitis ( Murray Valley encephalitis )                                     3
                    Central European tick-borne encephalitis virus                                            3
                    Absettarov                                                                                3                     V
                    Hanzalova                                                                                 3                     V
                    Hypr                                                                                      3                     v
                    Kumlinge                                                                                  3                     v
                    Dengue virus types 1 to 4                                                                 3
                    Hepatitis C virus                                                                         3                     D
                    Japanese B encephalitis                                                                   3                     V
                    Kyasanur Forest                                                                           3                     v
                    Louping ill                                                                               3
                    Omsk                                                                                      3                 V ( TBE )
                    Powassan                                                                                  3
                    Rocio                                                                                     3
                    Russian spring-summer encephalitis ( TBE )                                                3                     V
                    St. Louis encephalitis                                                                    3
                    Wesselsbron virus                                                                         3
                    West Nile virus                                                                           3
                    Yellow fever                                                                              3                     v
                    Other known flaviviruses known to be pathogenic                                           2
            Hepadnaviridae
                 Hepatitis B virus                                                                            3                   V, D
                 Hepatitis D virus ( Delta ) C *)                                                             3                   V, D
            Herpesviridae
                 Cytomegalovirus                                                                              2
                 Epstein-Barr virus                                                                           2
                 Herpesvirus simiae (B virus )                                                                3
                 Herpes simplex viruses 1 and 2                                                               2
                 Herpesvirus varicella-zoster                                                                 2
                 Human B-lymphotropic virus ( HBLV-HHV6 )                                                     2
            Orthomyxoviridae
                 Influenza viruses types A , B , & C                                                          2                     V
                 Tick-borne Orthomyxoviridae :                                                                2
                 Dhori & Thogoto viruses
            Papovaviridae
                 BK and JC virus                                                                              2                   D (*)
                 Human papillomaviruses                                                                       2                   D (*)
               (*) For work involving direct contact with these agents .
            ( * * ) Hepatitis D virus is only pathogenic in workers in the presence of simultaneous or secundary infection caused by Hepatitis B
                    virus .
 ---pagebreak--- 24 . 8 . 92                                       Official Journal of the European Communities                                                     No C 217 / 39
                                                  Biological agent                                        Classification             Notes
             Paramyxoviridae                                                                         l                       l
                  Measles virus                                                                                  2                    V
                  Mumps virus                                                                                    2                    V
                  Newcastle disease virus                                                                        2
                  Parainfluenza viruses types 1 to 4                                                           - 2
                  Respiratory syncytial virus                                                                    2
             Parvoviridae
                  Human parvovirus (B 19 )                                                                       2
             Picornaviridae
                  Acute haemorrhagic conjunctivitis virus ( AHC )                                                2
                  Coxsackieviruses                                                                               2
                  Echoviruses                                                                                    2
                  Hepatitis A virus ( human enterovirus type 72 )                                                2
                                                                                                                             l
                  Polioviruses                                                                                   2                    V
                  Rhinoviruses                                                                                   2
            Poxviridae                                                                                                       I
                  Buffalopox virus (')                                                                           2
                  Cowpox virus                                                                                   2
                  Elephantpox virus ( 2 )                                                                        2
                  Milkers' node virus                                                                            2
                  Molluscum contagiosum virus                                                                    2
                  Monkeypox virus                                                                                3                    V
                  Orf virus                                                                                      2
                  Rabbitpox virus ( 3 )                                                                          2
                  Vaccinia virus                                                                                 2
                 Variola ( major & minor ) virus                                                                 4                    V
                 White pox virus ('variola virus')                                                               4
                 Yatapox virus ( Tana & Yaba )                                                                   2
            Reoviridae
                 Coltiviruses                                                                                    2
                 Humane rotaviruses                                                                              2
                 Orbiviruses                                                                                     2
                 Reo viruses                                                                                     2
            Retroviridae (*)
                 Human immunodeficiency viruses ( AIDS )                                                         3                    D
                 Human T-cell lymphotropic viruses ( HTLV ) types 1 and 2                                        3                    D
            Rhabdoviridae
                 Rabies virus                                                                                    3                    V
                 Vesicular stomatitis virus                                                                      2
            (') Two viruses are identified: one a buffalopox type and the other a variant of the vaccinia virus .
            ( 2 ) Variant of cowpox virus .
            ( 3 ) Variant of 'vaccinia'.
            ( * ) At present there is no evidence of infection of humans with retroviruses of simian origin . As a precaution containment level 3 is
                  recommended for work with them .
 ---pagebreak--- No C 217 / 40                                    Official Journal of the European Communities                                                      24 . 8 . 92
                                                 Biological agent                                        Classification           Notes
            Togaviridae
                  Alphavirus :
                     Eastern equine encephalomyelitis                                                          3                     V
                     Bebaru virus                                                                              2
                     Chikungunya virus                                                                         2
                     Everglade virus                                                                           2
                     Mayaro virus                                                                              3
                     Mucambo virus                                                                             3
                     Ndumu virus                                                                               3
                     O'nyong-nyong virus                                                                       2
                     Ross River virus                                                                          2
                     Semliki Forest virus                                                                      2
                     Sindbis virus                                                                             2
                     Tonate virus                                                                              3
                     Venezuelan equine encephalomyelitis                                                       3                     V
                     Western equine encephalomyelitis                                                          3                     V
                     Other known alphaviruses                                                                  2
                  Rubivirus ( rubella )                                                                        2                     v
            Toroviridae                                                                                        2
            Unclassified viruses
                  Blood-borne hepatitis viruses not yet identified                                             3                     D
                  Hepatitis E virus                                                                            3
                  Norwalk virus                                                                                2
            Unconventional agents associated with i 1 ):
                  Creutzfeld-Jakob disease                                                                     3                  Dn
                  Gerstmann-Sträussler-Scheinker syndrome                                                      3                  D (*)
                  Kuru                                                                                         3                  Dn
            PARASITES
            Acanthamoeba castellani                                                                            2
            Ancylostoma duodenale                                                                              2
            Angiostrongylus cantonensis                                                                        2
            Angiostrongylus costaricensis                                                                      2
            Ascaris lumbricoides                                                                               2                     A
            Ascaris suum                                                                                       2                     A
            Babesia divergens                                                                                  2
            Babesia microti                                                                                    2
            Balantidium coli                                                                                   2
            Brugia malayi                                                                                      2
            Brugia pahangi                                                                                     2
             Capillaria philippinensis                                                                         2
             ( 1 ) There is no evidence in humans of infections caused by the agents responsible for bovine spongiform encephalitis and 'scrapie'.
                   Nevertheless , containment level 2 is recommended as a precaution for work involving contact with these agents or with tissues
                   infected by these agents .
             (») For work involving direct contact with these agents .
 ---pagebreak--- 24 . 8 . 92                                    Official Journal of the European Communities               No C 217 / 41
                                               Biological agents                     Classification Notes
             Capillaria spp . (*)                                                          2
             Clonorchis sinensis                                                           2
             Clonorchis viverrini                                                          2
             Cryptosporidium parvum                                                        2
             Cryptosporidium spp . (*)                                                     2
            Dipetalonema streptocerca                                                      2
            Diphyllobothrium latum                                                         2
            Dracunculus medinensis                                                         2
            Echinococcus granulosus                                                        3
            Echinococcus multilocularis                                                    3
             Echinococcus vogeli                                                           3
            Entamoeba histolytica                                                          2
            Fasciola gigantica                                                             2
            Fasciola hepatica                                                              2
            Fasciolopsis buski                                                             2
            Giardia lamblia (Giardia intestinalis)                                         2
            Hymenolepis diminuta                                                           2
            Hymenolepis nana                                                               2
            Leishmania brasiliensis                                                        3
            Leishmania donovani                                                            3
            Leishmania ethiopica                                                           2
            Leishmania mexicana                                                            2
            Leishmania peruviana                                                           2
            Leishmania tropica                                                             2
            Leishmania major                                                               2
            Leishmania spp . (*)                                                           2
            Loa loa                                                                        2
            Mansonella ozzardi                                                             2
            Mansonella perstans                                                            2
            Naegleria fowleri                                                              3
            Necator americanus                                                             2
            Onchocerca volvulus                                                            2
            Opisthorchis felineus                                                          2
            Opisthorchis spp . (*)                                                         2
            Paragonimus westermani                                                         2
            Plasmodium falciparum                                                          3
            Plasmodium spp . (*) ( human & simian )                                        2
            Sarcocystis sui hominis                                                        2
            Schistosoma haematobium                                                        2
            Schistosoma intercalatum                                                       2
            Schistosoma japonicum                                                          2
            Schistosoma mansoni                                                            2
            Schistosoma mekongi                                                            2
            (*) 4spp' refers to other species which are known pathogens in humans .
 ---pagebreak--- No C 217 / 42                                   Official Journal of the European Communities               24 . 8 . 92
                                                Biological agents                     Classification Notes
            Strongyloides stercoralis                                                        2
            Strongyloides spp . (*)                                                          2
             Taenia saginata                                                                 3
             Taenia solium                                                                   3
             Toxocara canis                                                                  2
             Toxoplasma gondii                                                               2
             Trichinella spiralis                                                            2
             Trichuris trichiura                                                             2
             Trypanosoma brucei brucei                                                       2
             Trypanosoma brucei gambiense                                                    3
             Trypanosoma brucei rhodesiense                                                  3
             Trypanosoma cruzi                                                               3
             Wuchereria bancroftii                                                           2
            FUNGI
            Aspergillus fumigatus                                                            2        A
            Blastomyces dermatitidis (Ajellomyces dermatidis)                               3
            Candida albicans                                                                .2        A
            Coccidioides immitis                                                            3         A
            Cryptococcus neoformans (Filobasidella neoformans var neoformans                2         A
            and F. neoformans var garrii)
            Emmonsia parvavum var. parva                                                    2
            Emmonsia parvavum var. crescens                                                 2
            Epidermophyton floccosum                                                        2         A
            Fonsecaea compacta                                                              2
            Fonsecaea pedrosoi                                                              2
            Histoplasma capsulatum var capsulatum (Ajellomyces capsulata)                   3
            Histoplasma duboisii                                                            3
            Madurella grisea                                                                2
            Madurella mycetomatis                                                            2
            Microsporum spp . (*)                                                           2         A
            Neotestudina rosatii                                                            2
            Paracoccidioides brasiliensis                                                    3
            Pénicillium marneffei                                                            2        A
            Sporothrix schenckii                                                             2
             Trichophyton rubrum                                                             2
            Trichophyton spp . (*)                                                           2
            (*) 'sop .' refers to other species which are known pathogens in humans .