24. 8. 89 Official Journal of the European Communities No C 218/5 
II 
(Preparatory Acts) 
COMMISSION 
Amended proposal for a Council Directive on the protection of workers from the risks related 
to exposure to biological agents at work (') 
COM(89) 404 final — SYN 129 
(Submitted by the Commission pursuant to the third paragraph of Article 149 of the EEC Treaty on 
2 August 1989) 
(89/C 218/04) 
0) OJ No C 150, 8. 6. 1988, p. 6. 
Seventh individual Directive within the meaning of 
Article 8 of Directive 80/1170/EEC Individual Directive within the meaning of Article 16 of 
Directive 89/391/EEC 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular article 118A 
thereof, unchanged 
Having regard to the proposal from the Commission, 
established following consultation with the Advisory 
Committee on Safety, Hygiene and Health Protection at 
Work, 
In cooperation with the European Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas Council Directive 80/1107/EEC of 27 
November 1980 on the protection of workers from the 
risks related to exposure to chemical, physical and bio­
logical agents at work (2), as amended by the Act of 
Accession of Spain and Portugal, provides for directives 
for certain agents; Whereas this Directive is an individual Directive within 
the meaning of Article 16 of Council Directive 
89/391/EEC (2) on the introduction of measures to 
encourage improvements in the safety and health of 
workers at work; whereas the provisions of the latter are 
therefore fully applicable to the exposure of workers to 
biological agents without prejudice to more stringent 
and/or specific provisions contained in the present 
Directive; 
O OJ No L 327, 3. 12. 1980, p. 8. O OJ No L 183, 29. 6. 1989, p. 1. 
No C 218/6 Official Journal of the European Communities 24. 8. 89 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Whereas, under the terms of the said Directive, such 
protection should as far as possible be ensured by 
measures to prevent exposure or to keep it at as low a 
level as is reasonably practicable; deleted 
Whereas more precise knowledge of the risks involved in 
exposure to biological agents at work can be obtained 
through the keeping of records; unchanged 
Whereas employers must keep abreast of new devel­
opments in, technology with a view to improving the 
protection of workers' health and safety; unchanged 
Whereas it is necessary, in order to ensure the highest 
degree of protection reasonably practicable, that workers 
and their representatives be informed about the risks 
which biological agents can pose for their health, and the 
measures necessary to lessen or eliminate those risks and 
that they should be in a position to ensure that the 
necessary protective measures are taken, unchanged 
Whereas, preventive measures should be taken for the 
protection of the health and safety of workers exposed 
to biological agents, unchanged 
HAS ADOPTED THIS DIRECTIVE: HAS ADOPTED THIS DIRECTIVE: 
Objective 
Article 1 
1. The purpose of this Directive, is to protect workers 
against risks to their health and safety, and to prevent 
such risks, arising or likely to arise from exposure to 
biological agents at work. Article 1 
1. This Directive, which is an individual Directive 
within the meaning of Article 16 of Directive 
89/391/EEC, has as its aim the protection of 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. It lays down 
particular minimum provisions in this area. 
2. This Directive shall apply to all workers with the 
exception of workers engaged in sea transport and in air 
transport. deleted 
For the purposes of this Directive 'workers engaged in 
sea transport and in air transport' means personnel on 
board. deleted 
2. Member States shall take the necessary steps to 
ensure that employers, workers and workers' represen­
tatives are subject to the legal provisions necessary for 
the implementation of this Directive. 
3. In particular, Member States shall ensure adequate 
controls and supervision. 
24. 8. 89 Official Journal of the European Communities No C 218/7 
ORIGINAL PROPOSAL 
Definitions AMENDED PROPOSAL 
Article 2 Article 2 
For the purposes of this Directive: 
(a) 'Biological agents' are microorganisms including 
those which have been genetically manipulated, cell 
cultures and multicellular human endoparasites. unchanged 
(b) A 'Group 1' biological agent is one that is most 
unlikely to cause human disease. It does not produce 
infection and is unlikely to spread in the community. 
This definition includes any genetically modified 
biological agent which fulfils the criteria for good 
microbiological practice as laid down in Annex I. unchanged 
(c) A 'Group T biological agent is one that may cause 
human disease and might be a hazard to workers. It 
rarely produces infection. It is unlikely to spread in 
the community and there is usually effective 
prophylaxis or treatment available. unchanged 
(d) A 'Group 3' biological agent is one that may cause 
severe human disease and presents a serious hazard 
to workers. It may present a risk of spread in the 
community but there is usually effective prophylaxis 
or treatment available. unchanged 
(e) A 'Group 4' biological agent is one that causes severe 
human disease and is a serious hazard to workers. It 
may present a high risk of spread in the community 
and there is usually no effective prophylaxis or 
treatment available. unchanged 
(f) 'Micro-organism' is any microscopic unicellular or unchanged 
subcellular biological entity capable of replication. 
(g) 'Genetically modified biological agent' is an unchanged 
organism derived by the techniques of genetic 
manipulation. 
(h) 'Genetic manipulation' is the formation of a new 
combination of genetic material by the insertion of 
nucleic acid molecules produced by whatever means 
outside the cell, into any virus, bacterial plasmid or 
other vector system so as to allow their incorporation 
into a host organism in which they do not naturally 
occur but in which they are capable of continued 
propagation. unchanged 
No C 218/8 Official Journal of the European Communities 24. 8. 89 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
(i) 'Cell culture' is the in vitro growth of cells isolate unchanged 
from multicellular organisms. 
(j) 'Incidental exposure to biological agents' is any work 
activity or sector of activity in which there is no 
deliberate intention to handle or use biological 
agents but where the work activity may result in 
workers being exposed to biological agents, 
including contact with animals and animal products 
where there may be a risk of exposure to zoonotic 
agents, and sewage and health care activities where 
they may be a risk of exposure to persons or patho­
logical material with infectious disease. unchanged 
(k) 'Conscious decision to work with biological agents' 
is any work activity or sector of activity in which the 
purpose of the work biological agents, including 
work in research laboratories or industrial processes 
employing biological agents. unchanged 
Assessment 
Article 3 
1. This Directive shall apply to work activities in 
which workers are or are potentially exposed to bio­
logical agents as a result of their work activities. Article 3 
unchanged 
2. In the case of any activity or sector of activity likely 
to involve a risk of exposure to biological agents the risk 
must be assessed. Member States shall fix the conditions 
of this assessment and of any further assessment, if 
necessary, and shall determine by whom it is to be 
conducted. The assessment shall be conducted so as to 
determine the nature and degree of the: 2. In the case of any activity or sector of activity likely 
to involve the risk of exposure to biological agents the 
risk must be assessed. Member States shall fix the 
conditions of this assessment and of any further 
assessment, if necessary, and shall determine by whom it 
is to be conducted. The assessment should furthermore 
allow the classification of the biological agents to Groups 
1 to 4 (Article 2 (b) to (e)). Pending a Community classi­
fication (Annex V) this classification shall be made by 
the Member States. The assessment shall be conducted 
so as to determine the nature and degree of the: 
— inherent hazard of a biological agent to health, unchanged 
— risk of workers' exposure or potential exposure, unchanged 
including a determination of whether this involves 
either incidental exposure, or a conscious decision to 
work with biological agents, 
— effectiveness of prophylactic and therapeutic 
measures in the event of infections of other health 
hazards, 
24. 8. 89 Official Journal of the European Communities No C 218/9 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
— risk of transfer from the workplace to the unchanged 
community, 
— risk of further spread within the community. unchanged 
This assessment shall not apply to genetically modified 
biological agents which have been notified in accordance 
with the provisions of Council Directive .../.. ./EEC. unchanged 
3. The identification of a biological agent as being 
hazardous to health shall be based on all available infor­
mation including: 3. The assessment of a biological agent as being 
hazardous to health shall be based on all available infor­
mation including: 
diseases which may be caused through direct 
connection with a work activity, 
a disease from which a worker is found to be 
suffering which has a direct connection with his work 
activity and/or epidemiology which indicates that a 
biological agent has been a source of human 
infection and/or illness, a disease from which a worker is found to be 
suffering which has a direct connection with his work 
activity and/or epidemiology which indicates that a 
biological agent has been or may be a source of 
human infection and/or illness, 
guidelines issued by a responsible authority which 
indicate that a biological agent should be controlled 
in some way in order to prevent human infection 
and/or illness when workers are or are potentially 
exposed to such an agent as a result of their work 
activity. guidelines issued by a responsible authority, to be 
designated by the Member State in consultation with 
the Commission, which indicate that the biological 
agent should be controlled in some way in order to 
prevent human infection and/or illness when workers 
are or are potentially exposed to such an agent as a 
result of their work activity. 
4. Biological agents shall be assessed on the basis of 
the maximum degree of hazard, unless there is evidence, 
in individual cases, that the degree of hazard is lower. 4. Biological agents shall be assessed on the basis of 
the maximum degree of hazard unless there is evidence, 
exceptionally and in individual cases, that the degree of 
hazard is lower. 
The assessment of a genetically modified biological agent unchanged 
shall be made, when appropriate, on the same basis. 
Where biological agents cannot be clearly assigned to 
one of the groups set out in Article 2 (b) to (e), they 
shall be assigned to the group presenting the greatest 
degree of hazard. 
5. This Directive shall apply without prejudice to the 
provisions of Council Directive .../.. ./EEC on the 
contained use of genetically modified micro-organisms. unchanged 
6. Articles 4 to 17, with the exception of the first 
indent of Article 9, shall not apply if the assessment 
referred to in paragraph 2 shows that the exposure 
and/or potential exposure is to a Group 1 biological 
agent or to a biological agent which causes disease only 
in animals and/or in plants and that there is no ident­
ifiable health risk to workers. 6. Articles 4 to 17, with the exception of the first 
indent of Article 9, shall not apply if the assessment 
referred to in paragraph 2 shows that the exposure 
and/or potential exposure is to a Group 1 biological 
agent with no identifiable health risk to workers. 
No C 218/10 Official Journal of the European Communities 24. 8. 89 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
7. Articles 6 to 14 shall not apply if the assessment 
referred to in paragraph 2 shows that the work activities 
involve only incidental exposure to biological agents. Articles 6 to 14 shall apply if the assessment referred to 
in paragraph 2 shows that the work activities involve a 
conscious decision to work with biological agents. 
If the assessment referred to in paragraph 2 shows that 
the activities involve only incidental exposure to bio­
logical agents, the provisions of Articles 6 to 14 shall 
become applicable from the moment they are shown to 
be necessary. 
General provisions applicable to work activities which 
involve both incidental exposure to biological agents and 
a conscious decision to work with biological agents unchanged 
Article 4 
The risk of workers' exposure must be avoided. Where 
this is not reasonably practicable, having regard to the 
work activity and the risk assessment referred to in 
Article 3 (2) exposure shall be reduced to as low a level 
as is necessary in order to protect adequately the health 
and safety of the workers concerned, in particular by the 
following measures which are to be applied when appro­
priate : Article 4 
1. The risk of workers' exposure must be avoided. 
Where this is not practicable, having regard to the work 
activity and the risk assessment referred to in Article 3 
(2) exposure shall be reduced to as low a level as 
necessary in order to protect adequately the health and 
safety of the workers concerned, in particular by the 
following measures which are to be applied in the light 
of the result of the risk assessment referred to in Article 
3 (2): 
(a) the limitation of the number of workers exposed or unchanged 
potentially exposed; 
(b) the prevention of exposure or its adequate control by unchanged 
the appropriate design of work processes and/or the 
use of engineering control measures; 
(c) collective protection measures including the use and unchanged 
maintenance of adequate equipment; 
(d) personal protection measures, where exposure 
cannot reasonably be avoided by other means; (d) personal protection measures and equipment, where 
exposure cannot be avoided by other means; 
(e) hygiene measures designed to prevent the accidental unchanged 
transfer or release of a biological agent from the 
workplace; 
(f) the provision of up-to-date information on biological deleted 
agents which are or may be present at the workplace 
together with a continuing programme of adequate 
training for workers; 
(g) use of a biohazard sign (Annex II) and other 
warning signs; 
(h) emergency procedures designed to minimize 
workers' exposure resulting from a serious accident 
or incident. (becomes f) use of the biohazard sign depicted in Annex 
II and other warning signs; 
unchanged (becomes g) 
24. 8. 89 Official Journal of the European Communities No C 218/11 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
2. Employers shall take the appropriate measures to 
ensure that workers and/or their representatives in the 
undertaking or establishment receive appropriate and 
up-to-date information, based on all available infor­
mation, concerning, biological agents which are or may 
be present at the workplace, together with appropriate 
instruction where necessary, and a continuing 
programme of appropriate training. 
Article 5 
1. At the beginning of employment and at regular 
intervals thereafter, the workers shall receive up to date 
information together with adequate instruction, so that 
they are made aware of all the requirements laid down in 
Article 4. Article 5 
unchanged 
2. Appropriate measures shall be taken to ensure that 
workers and/or any workers' representatives in the 
undertaking or establishment can receive explanations on 
the potential risks to health from exposure to biological 
agents, the hygiene requirements, and the emergency 
procedures designed to minimize workers' exposure 
resulting from a serious accident or incident. 2. Employers shall take appropriate measures to 
ensure that workers and/or workers' representatives in 
the undertaking or establishment receive explanations on 
the potential risks to health from exposure to biological 
agents, the hygiene requirements, and the emergency 
procedures designed to minimize workers' exposure 
resulting from a serious accident or incident. 
Additional provisions applicable to work activities which 
involve a conscious decision to work with biological 
agents Hygiene measures, protective clothing and equipment 
Article 6 
1. Appropriate measures shall be taken so far as is 
reasonably practicable for the protection of the health 
and safety of workers by providing that: Article 6 
1. Employers shall be required to take the following 
measures for all work activities in which there is a safety 
and health risk to workers: 
(a) areas are set aside where workers can eat and drink unchanged 
without risking contamination by biological agents; 
(b) workers are provided with appropriate protective unchanged 
clothing or other appropriate special clothing; 
(c) separate storage places are provided for working or unchanged 
protective clothing and for street clothes; 
(d) protective respiratory equipment is placed in a well-
defined place and is checked, if possible before, and 
in any case after each use; defective equipment shall 
be repaired or replaced before further use. unchanged 
No C 218/12 Official Journal of the European Communities 24. 8. 89 
ORIGINAL PROPOSAL 
2. Working clothes and personal protective 
equipment, including protective clothing which may be 
contaminated by biological agents, must be removed on 
leaving the working area and stored separately from 
other clothing. The employer must ensure that such 
clothing and personal protective equipment are disin­
fected, cleaned or, if necessary, destroyed. 
3. Workers who handle biological agents must be 
provided with skin and eye antiseptics, suitable washing 
facilities and, if appropriate, showers. 
4. Workers may not be charged for the cost of 
measures taken pursuant to paragraphs 1, 2 and 3. 
Article 7 
1. Employers shall keep a record of workers exposed 
or potentially exposed to Group 3 and/or Group 4 bio­
logical agents indicating the type of work done, and 
whenever possible the biological agent to which they 
may have been exposed, as well as records of accidents 
and incidents, as appropriate. 
2. The records referred to in paragraph 1 shall be kept 
for at least 10 years following the end of exposure, in 
accordance with national laws and practice. 
3. The doctor and/or the authority responsible for 
health and safety at work shall have access to the records 
referred to in paragraph 1. 
4. Each worker shall have access to information in the 
records which relates to him personally. 
5. Workers and/or any workers' representatives in the 
undertaking or establishment shall have access to 
anonymous collective information in the records. AMENDED PROPOSAL 
unchanged 
unchanged 
unchanged 
Records of exposed workers 
Article 7 
unchanged 
2. The research referred to in paragraph 1 shall be 
kept for at least 40 years following the end of exposure, 
in accordance with national laws and practice. 
3. The doctor and/or the authority responsible for 
health and safety at work, and any other person 
responsible for health and safety at work, shall have 
access to the records referred to in paragraph 1. 
unchanged 
unchanged 
24. 8. 89 Official Journal of the European Communities No C 218/13 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Article 8 
1. The use of a Group 3 or 4 biological agent shall be 
avoided, as far as is reasonably practicable by its 
replacement by a less hazardous or non-hazardous 
agent. Article 8 
1. The use of a Group 3 or 4 biological agent must be 
avoided by substituting a less hazardous or 
non-hazardous agent, where this is technically prac­
ticable. 
2. Suppliers or importers of a Group 3 or 4 biological 
agent for use at work shall ensure that they are 
adequately described, packed and transported. 2. Suppliers or importers of a Group 3 or 4 biological 
agent for use at work shall ensure: 
(a) the safe handling and transport of such agents, in 
particular through the use of airtight containers 
which are clearly and visibly labelled; 
(b) the safe collection, storage and disposal of waste, 
through, inter alia, the use of airtight containers 
which are clearly and visibly labelled. 
Worker consultation and participation 
Article 9 
Employers shall on request make available to the 
responsible authorities appropriate information on: 
— the results of the assessment referred to in Article 3 
(2), 
— the activities in which workers have been exposed or 
potentially exposed to biological agents, 
— the number of workers exposed, 
— the name of the person responsible for safety and 
health at work, 
— the protective and preventive measures taken 
including working procedures and methods, 
— an emergency plan for the protection of workers 
from exposure to a Group 3 or 4 biological agent 
which might result from a loss of physical 
containment. Article 9 
Employers shall on request make available to the 
responsible authorities, and to workers and/or workers' 
representatives, appropriate information on: 
unchanged 
unchanged 
unchanged 
— the name and qualifications of the person responsible 
for safety and health at work, 
unchanged 
unchanged 
Worker information 
Article 11 
1. Employers shall display written instructions at the 
workplace which shall include the procedure to be used 
in the case of: Becomes Article 10 
1. Employers shall display written instruction at the 
workplace which shall, as a minimum, include the 
procedure to be followed in the case of: 
— a serious accident or incident, unchanged 
— work with a Group 4 biological agent. unchanged 
No C 218/14 Official Journal of the European Communities 24. 8. 89 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
2. A serious accident or incident shall be reported 
immediately to and recorded by the person responsible 
for the work. 2. Any accident or incident shall be reported 
immediately to the person responsible for safety and 
health at work. 
3. Workers and/or any workers' representatives in the 
undertaking or establishment shall be informed as 
quickly as possible when a serious accident or incident 
occurs, of the causes thereof, and of the measures taken 
or to be taken to rectify the situation. unchanged 
Article 10 
1. Without prejudice to Directive .../.. ./EEC on the 
deliberate release of genetically modified organisms, 
employers shall give a prior notification to the 
responsible authority, at least 60 days before: 
— an intention to carry out genetic manipulation work 
or to work with a genetically modified biological 
agent in Group 2, 3 or 4, 
— an intention to introduce substantial changes to a 
procedure which has already been notified, 
— work with a Group 4 biological agent, or if there is 
an intention to handle, store or transport such an 
agent. 
2. In the case of genetic manipulation work, or work 
with a genetically modified biological agent, prior notifi­
cation shall include the name and address of the under­
taking and/or establishment and the name of the person 
responsible for safety and health at work. Specific provisions applicable to the use of genetically 
modified biological agents 
Becomes Article 11 
1. Without prejudice to Directive 89/.. ./EEC on the 
deliberate release of genetically modified organisms, and 
Directive 89/.. ./EEC on the use of genetically modified 
micro-organisms in contained systems, employers shall 
give a prior notification to the responsible authority and 
to the workers and/or their representatives, at least 90 
days before work is planned to commence, of: 
— an intention to carry out genetic manipulation work 
or to work with a genetically modified biological 
agent, 
unchanged 
unchanged 
2. The prior notification shall include: 
— the name and address of the undertaking and/or 
establishment, 
— the name and qualifications of the person responsible 
for safety and health at work. 
In the case of a Group 4 biological agent this prior noti­
fication shall include: 
— the result of the assessment referred to in Article 3 
(2), 
— the name of the biological agent, 
the protection and preventive measures that are 
envisaged, 
the name of the person responsible for safety and 
health at work. unchanged 
unchanged 
— the name and taxonomic description of the biological 
agent, 
unchanged 
deleted 
24. 8. 89 Official Journal of the European Communities No C 218/15 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
3. Employers shall inform forthwith the responsible 
authority of any accident or incident that may have 
resulted in the release of any biological agent such that it 
could cause severe human infection and/or illness. 3. Employers shall inform forthwith the responsible 
authority and workers of any accident or incident that 
may have resulted in the release of any biological agent 
which could cause severe human infection and/or illness. 
Medical surveillance 
Article 12 
1. The specific rules for the health surveillance of 
workers shall be established by the Member States in 
accordance with national law and practice. Article 12 
unchanged 
2. Members States shall make arrangements to ensure 
that, where relevant, each worker can undergo an 
assessment of his state of health prior to potential 
exposure. This assessment should be such that it is 
directly possible to implement individual and hygiene 
measures. 2. Member States shall make arrangements to ensure 
that each worker can undergo an assessment of his state 
of health prior to potential exposure. This assessment 
should be such that it is directly possible to implement 
individual and hygiene measures. 
3. Where relevant, the assessment referred to in 
paragraph 2 should identify those workers for whom 
special protective measures may be required. When 
appropriate, effective vaccines should be made available 
for those workers who are not already immune to the 
biological agent to which they are exposed or are poten­
tially exposed. 3. The assessment referred to in paragraph 2 should 
identify those workers for whom special protective 
measures may be required. When appropriate, effective 
vaccines should be made available for those workers who 
are not already immune to the biological agent to which 
they are exposed or are potentially exposed. 
4. If a worker is found to be suffering from an 
infection and/or illness which is suspected of being the 
result of exposure, the doctor or authorities responsible 
for health surveillance may decide that other workers 
similarly exposed shall undergo assessments of their state 
of health, and may require a reassessment of the risk of 
exposure as referred to in Article 3 (2). unchanged 
5. When the assessments referred to in this Article 
have been made, an individual health record shall be 
kept for at least 10 years following the end of exposure, 
in accordance with national laws and practice. 5. When the assessments referred to in this Article 
have been made, an individual health record shall be 
kept for at least 40 years following the end of exposure, 
in accordance with national laws and practice. 
The doctor or authority responsible for health 
surveillance may propose protective measures to be taken 
in respect of any individual worker. The doctor or authority responsible for health 
surveillance may propose protective measures to be taken 
in respect of any individual worker under certain circum­
stances, but without identifying the individual in question 
to third parties. 
6. The worker concerned or the employer may 
request a review of the assessments referred to in this 
Article, in accordance with national laws and practice. unchanged 
No C 218/16 Official Journal of the European Communities 24. 8. 89 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Special measures for health care facilities and diagnostic unchanged 
laboratories 
Article 13 
1. Specific measures shall be taken for health care 
facilities, in particular isolation and post-mortem units, 
and clinical, veterinary and diagnostic laboratories. Article 13 
unchanged 
2. For the purposes of the assessment referred to in unchanged 
Article 3 (2), particular attention shall be paid to: 
— uncertainties about the presence of biological agents unchanged 
in the materials and specimens being investigated, 
— the hazard of biological agents known or suspected unchanged 
to be present in the materials or specimens, 
— the risk posed by the nature of the work activity. unchanged 
3. The specific measures listed in Annex III for the unchanged 
physical containment of biological agents shall be 
applied, when appropriate. 
Special measures for industrial processes, laboratories and unchanged 
animal rooms 
Article 14 
1. Specific measures shall be taken for industrial 
processes, animal rooms and laboratories, excluding 
clinical, veterinary and diagnostic laboratories in order 
to ensure the physical containment of a Group 2, 3 or 4 
biological agent. Article 14 
unchanged 
For this purpose Member States shall classify biological unchanged 
agents using the definitions in Article 2 (c), (d) and (e) 
relating respectively to a Group 2, 3 or 4 biological 
agent. 
2. Following the assessment referred to in Article 3 (2) unchanged 
special measures shall be taken as laid down in Annex III 
after matching the physical containment level for bio­
logical agents with the degree of risk. 
For this purpose work activities involving: unchanged 
— a Group 2 biological agent may be carried out only unchanged 
in working areas corresponding to at least the 
physical containment level 2, 
24. 8. 89 Official Journal of the European Communities No C 218/17 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
a Group 3 biological agent may be carried out only 
in working areas corresponding to at least the 
physical containment level 3, unchanged 
a Group 4 biological agent may be carried out only 
in working areas corresponding to the physical 
containment level 4. unchanged 
3. When the volume of the biological agents which 
are being handled in Groups 2 and/or 3, justifies it, the 
physical containment level' shall be increased, when 
appropriate, to at least the level 3 or 4 respectively, in 
order to ensure that the health and safety risks are 
minimized. 3. When the volume of Groups 2 and/or 3 biological 
agents handled justifies it, the physical containment level 
shall be increased, when appropriate, to at least level 3 
or 4 respectively, in order to ensure that the health and 
safety risks are minimized, taking into account the 
containment levels. 
4. In an industrial process in which there is adequate 
physical containment of biological agents by means of a 
closed system, the specific measures listed in points 1 and 
2 of Annex III shall be applied only when appropriate. unchanged 
5. In the case of a biological agent in respect of which 
a conclusive assessment has not yet been possible as 
referred to in Article 3 (2), but the indications are that a 
risk to health might arise from the proposed use, then 
work activities may be carried out only in working areas 
corresponding to at least the physical containment level 
3. unchanged 
6. The additional measures required for laboratories unchanged 
and animal rooms are listed in Annex IV. 
Final provisions 
Article 15 
The Annexes to this Directive may be adapted to 
technical progress in accordance with the procedure set 
out in Article 10 of Directive 80/1107/EEC. Article 15 
The procedure described in Article 17 of Directive 
89/391/EEC shall be used: 
for the establishment of Annex V as mentioned 
Ai-tiVl» \ Article 3, in 
— for the regular adaptation to technical progress of the 
Annexes to this Directive. 
Article 16 
Member States shall ensure that workers and/or 
workers' representatives where they exist in an under­
taking or establishment are consulted on the provisions 
referred to in this Directive and that they can be 
involved in their application. Article 16 
unchanged 
No C 218/18 Official Journal of the European Communities 24. 8. 89 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Article 17 
1. Member States shall keep national statistics of 
recognized cases of serious illness or death due to 
exposure to biological agents at work. Article 17 
1. Member States shall keep and publish national stat­
istics of cases of illness or death due to exposure due to 
biological agents at work and shall regularly 
communicate these statistics to the Commission. 
2. Member States shall publish up-to-date and appro­
priate information on occupational diseases caused by 
biological agents. unchanged 
Article 18 
1. Member States shall adopt the laws, regulations unchanged 
and administrative provisions necessary to comply with 
this Directive before 1 January 1992. They shall 
immediately inform the Commission thereof. 
2. Member States shall communicate to the unchanged 
Commission the provisions of national law which they 
adopt in the field governed by the Directive. Article 18 
Article 19 
This Directive is addressed to the Member States. unchanged Article 19 
ANNEX I unchanged 
ANNEX II ANNEX II 
Biohazard sign as referred to in Article 4 (g) Biohazard sign as referred to in Article 4 (f) 
ANNEX III unchanged 
ANNEX IV unchanged 
24. 8. 89 Official Journal of the European Communities No C 218/19 
ANNEX K(new) 
Classification of biological agents (Article 3) 
'Group 1' biological agents: 
'Group 2' biological agents: 
'Group 3' biological agents: 
'Group 4' biological agents: To be completed 
To be completed 
To be completed 
To be completed