No C 150/6 Official Journal of the European Communities 8. 6. 88 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive on the protection of workers from the risks related to 
exposure to biological agents at work 
COM(88) 165 final 
(Submitted by the Commission on 19 April 1988) 
(88/C 150/05) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 118A 
thereof, 
Having regard to the proposal from the Commission, 
established following consultation with the Advisory 
Committee on Safety, Hygiene and Health Protection at 
Work, 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; 
Whereas, preventive measures should be taken for the 
protection of the health and safety of workers exposed 
to biological agents, 
In cooperation with the European Parliament, 
HAS ADOPTED THIS DIRECTIVE: 
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 
biological agents at work ('), as amended by the Act of 
Accession of Spain and Portugal, provides for Directives 
for certain agents; 
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; 
Whereas more precise knowledge of the risks involved in 
exposure to biological agents at work can be obtained 
through the keeping of records; 
Whereas employers must keep abreast of new devel­
opments in technology with a view to improving the 
protection of workers' health and safety; 
O OJ No L 327, 3. 12. 1980, p. 8. 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. 
2. This Directive shall apply to all workers with the 
exception of workers engaged in sea transport and in air 
transport. 
For the purposes of this Directive 'workers engaged in 
sea transport and in air transport' means personnel on 
board. 
Definitions 
Article 2 
For the purposes of this Directive: 
(a) 'Biological agents' are micro-organisms including 
those which have been genetically manipulated, cell 
cultures and multicellular human endoparasites. 
8. 6. 88 Official Journal of the European Communities No C 150/7 
(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. 
(c) A 'Group 2' 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. 
(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. 
(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. 
(f) 'Micro-organism' is any microscopic unicellular or 
subcellular biological entity capable of replication. 
(g) 'Genetically modified biological agent' is an 
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. 
(i) 'Cell culture' is the in vitro growth of cells isolated 
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 
there may be a risk of exposure to persons or patho­
logical material with infectious disease. 
(k) 'Conscious decision to work with biological agents' 
is any work activity or sector of activity in which the 
purpose of the work is to handle or use biological 
agents, including work in research laboratories or 
industrial processes employing biological agents. 
Assessment 
Article 3 
1. This Directive shall apply to work activities in 
which workers are or are potentially exposed to 
biological agents as a result of their work activities. 
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: 
— inherent hazard of a biological agent to health, 
— risk of workers' exposure or potential exposure, 
including a determination of whether this involves 
either incidental exposure, or a conscious decision to 
work with biological agents, 
— risk of transfer from the workplace to the 
community; 
— risk of further spread within the community. 
This assessment shall not apply to genetically modified 
biological agents which have been notified in accordance 
with the provisions of Council Directive .../.. ./EEC 
[on deliberate release into the environment of genetically 
modified organisms]. 
3. The identification of a biological agent as being 
hazardous to health shall be based on all available infor­
mation including: 
— 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, 
No C 150/8 Official Journal of the European Communities 8. 6. 88 
— 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. 
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. 
The assessment of a genetically modified biological agent 
shall be made, when appropriate, on the same basis. 
5. This Directive shall apply without prejudice to the 
provisions of Council Directive .../.. ./EEC on the 
contained use of genetically modified micro-organisms. 
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 identifiable 
health risk to workers. 
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. 
General provisions applicable to work activities which 
involve both incidental exposure to biological agents and 
a conscious decision to work with biological agents 
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 
appropriate: 
(a) the limitation of the number of workers exposed or 
potentially exposed; 
(b) the prevention of exposure or its adequate control by 
the appropriate design of work processes and/or the 
use of engineering control measures; 
(c) collective protection measures including the use and 
maintenance of adequate equipment; (d) personal protection measures, where exposure 
cannot reasonably be avoided by other means; 
(e) hygiene measures designed to prevent the accidental 
transfer or release of a biological agent from the 
workplace; 
(f) the provision of up-to-date information on biological 
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. 
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. 
2. Appropriate measures shall be taken to ensure that 
workers and/or any 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 
Article 6 
1. Appropriate measures shall be taken so far as is 
reasonably practical for the protection of the health and 
safety of workers by providing that: 
(a) areas are set aside where workers can eat and drink 
without risking contamination by biological agents; 
(b) workers are provided with appropriate protective 
clothing or other appropriate special clothing; 
(c) separate storage places are provided for working or 
protective clothing and for street clothes; 
8. 6. 88 Official Journal of the European Communities No C 150/9 
(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. 
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 Groups 3 and/or 4 biological 
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. 
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. 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. 
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 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 
notification shall include the name and address of the 
undertaking and/or establishment and the name of the 
person responsible for safety and health at work. 
In the case of a Group 4 biological agent prior notifi­
cation shall include: 
— the result of the assessment referred to in Article 3 
(2), 
No C 150/10 Official Journal of the European Communities 8. 6. 88 
— 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. 
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. 
Article 11 
1. Employers shall display written instructions at the 
workplace which shall include the procedure to be used 
in the case of: 
— a serious accident or incident, 
— work with a Group 4 biological agent. 
2. A serious accident or incident shall be reported 
immediately to and recorded by the person responsible 
for the 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. 
Article 12 
1. The specific rules for the health surveillance of 
workers shall be established by Member States in 
accordance with national law and practice. 
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. 
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 
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). 
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. 
The doctor or authority responsible for health 
surveillance may propose protective measures to be taken 
in respect of any individual worker. 
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. 
Special measures for health care facilities and diagnostic 
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. 
2. For the purposes of the assessment referred to in 
Article 3 (2), particular attention shall be paid to: 
— uncertainties about the presence of biological agents 
in the materials and specimens being investigated, 
— the hazard of biological agents known or suspected 
to be present in the materials or specimens, 
— the risk posed by the nature of the work activity. 
3. The specific measures listed in Annex III for the 
physical containment of biological agents shall be 
applied, when appropriate. 
8. 6. 88 Official Journal of the European Communities No C 150/11 
Special measures for industrial processes, laboratories and 
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. 
For this purpose Member States shall classify biological 
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), special measures shall be taken as laid down in 
Annex III after matching the physical containment level 
for biological agents with the degree of risk. 
For this purpose work activities involving: 
— a Group 2 biological agent may be carried out only 
in working areas corresponding to at least the 
physical containment level 2, 
— a Group 3 biological agent may be carried out only 
in working areas corresponding to at least the 
physical containment level 3, 
— a Group 4 biological agent may be carried out only 
in working areas corresponding to the physical 
containment level 4. 
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. 
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. 
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. 
6. The additional measures required for laboratories 
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 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 17 
1. Member States shall keep national statistics of 
recognized cases of serious illness or death due to 
exposure to biological agents at work. 
2. Member States shall publish up-to-date and appro­
priate information on occupational diseases caused by 
biological agents. 
Article 18 
1. Member States shall adopt the laws, regulations 
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 
Commission the provisions of national law which they 
adopt in the field governed by this Directive. 
Article 19 
This Directive is addressed to the Member States. 
No C 150/12 Official Journal of the European Communities 8. 6. 88 
ANNEX I 
For genetically modified micro-organisms the criteria have to be established which permit a comparison of 
such micro-organisms with natural micro-organisms, in order to be able to determine to which group they 
belong and therefore which level of physical confinement should be applied. 
In this Annex the following definitions are given: 
— 'Host organism' is the organism into which donor DNA is inserted in rDNA constructions; it provides 
the major portion of the genome of the rDNA organism; same as recipient. 
— 'Vector' is an agent of transmission; for example a DNA vector is a self-replicating molecule of DNA 
that transmits genetic information from one cell or organism to another. Plasmids (and some viruses) 
are used as 'vectors' for DNA in bacterial cloning. 
The genetically modified micro-organism will have essentially the properties of the host, the genetic 
material of which is most often found integrated in the genetically modified micro-organism with only one 
foreign fragment more. 
The following table sets out the criteria for good microbiological practice (GMP) as referred to in Article 
2 (b) for a genetically modified biological agent: 
Host organism 
Non-pathogenic 
No adventitious agents 
Extended history of safe 
industrial use; or 
Built-in limitations permitting 
optimal growth in industrial 
setting but limited survival 
without adverse consequences 
outside the industrial setting rDNA engineered organism 
Non-pathogenic 
As safe in industrial setting as 
host organism, but with limited 
survival without adverse conse­
quences for human health Vector/insert 
Well characterized and free from 
known harmful sequences 
Limited in size as much as 
possible to the DNA required to 
perform the intended function; 
should not increase the stability 
of the construct (unless that is a 
requirement of the intended 
function) 
Should be poorly mobilizable 
Should not transfer any resistance 
markers to micro-organisms not 
known to acquire them naturally 
(if such acquisition could 
compromise use of drug to 
control disease agents) 
There are two clear examples of other classes of organisms that warrant the GMP designation unless they 
are pathogenic: 
(i) those constructed entirely from a single prokaryotic host (including its indigenous plasmids and 
viruses) or from a single eukaryotic host (including its choroplasts, mitochondria or plasmids — but 
excluding viruses —); and 
(ii) those consisting entirely of DNA segments from different species that exchange DNA by known physi­
ological processes. 
For the purpose of this table, 'non-pathogenic' means an agent which does not cause human disease. 
8. 6. 88 Official Journal of the European Communities No C 150/13 
ANNEX II 
Biohazard sign as referred to in Article 4 (g) 
ANNEX III 
The specific measures required at each of the three physical containment levels, as referred to in Articles 13 
(3) and 14 (2), (3), (4) and (5) 
Specific measures 
1. The workplace is to be in an isolated part of 
a building and separated by an anteroom with 
two doors 
2. Input air and extract air to the workplace are 
to be filtered using HEPA or similar 
3. Access is to be restricted to nominated 
workers only 
4. The workplace is to be sealable to permit 
disinfection 
5. Specified disinfection procedures 
6. The workplace is to be maintained at an air 
pressure negative to atmosphere 
7. Efficient vector control (e.g. rodents and 
insects) 
8. Collection and treatment of effluents 
9. Surfaces impervious to water 
10. Surfaces resistant to acids, alkalis, solvents, 
disinfectants 
11. Safe storage of a biological agent Containment levels 
1 
Recom­
mended 
No 
Recom­
mended 
No 
Yes 
No 
Recom­
mended 
No 
Yes, for 
bench 
Recom­
mended 
Recom­
mended 2 
Yes 
Yes, on extract 
air 
Yes 
Recommended 
Yes 
Recommended 
Yes 
Recommended 
Yes, for 
bench and 
floor 
Yes 
Yes 3 
Yes 
Yes, on input 
and extract air 
Yes, via an 
airlock 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes, for bench, 
floor and 
ceilings 
Yes 
Yes, secure 
storage 
No C 150/14 Official Journal of the European Communities 8. 6. 88 
ANNEX IV 
The additional measures required at each of the three physical containment levels for laboratories and 
animal rooms, as referred to in Article 14 (6) 
Specific measures 
1. An observation window, or alternative, is to be 
present, so that occupants can be seen 
2. A laboratory is to contain own equipment 
3. A microbiological safety cabinet is to be used 
4. Infected material including any animal is to be 
handled in a safety cabinet or isolator 
5. Autoclave or incinerator for animals Containment levels 
1 
Recom­
mended 
No 
Recom­
mended 
Recom­
mended 
Recom­
mended 2 
Recom­
mended 
Recom­
mended 
Yes 
Yes 
Yes 3 
Yes 
Yes 
Yes, with glove 
ports 
Yes 
Yes