Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)
Date: 2000-09-18
Institutions: Council of the European Union, European Parliament
Subjects: application of EU law, biotechnology, employer, health risk, occupational health

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DIRECTIVE 2000/54/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 18 September 2000

on the protection of workers from risks related to exposure to biological agents at work

(seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 137(2) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the Economic and Social
Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article
251 of the Treaty (2),

Whereas:

(1)

(2)

(3)

Council Directive 90/679/EEC of 26 November 1990 on
the protection of workers from risks related to exposure
to biological agents at work (seventh individual Directive
within the meaning of Article 16(1) of Directive 89/
391/EEC) (3) has been substantially amended on a
number of occasions (4). For the sake of clarity and
rationality Directive 90/679/EEC should be codified.

Compliance with the minimum requirements designed
to guarantee a better standard of safety and health as
regards the protection of workers from the risks related
to exposure to biological agents at work is essential to
ensure the safety and health of workers.

This Directive is an individual Directive within the
meaning of Article 16(1) of Council Directive 89/
391/EEC of 12 June 1989 on the introduction of meas-
ures to encourage improvements in the safety and health
of workers at work (5). The provisions of that Directive
are therefore fully applicable to the exposure of workers
to biological agents, without prejudice to more stringent
and/or specific provisions contained in this Directive.

(4)

involved in
More precise knowledge of
exposure to biological agents can be obtained through
the keeping of records.

the risks

(1) OJ C 75, 15.3.2000, p. 15.
(2) Opinion of

the European Parliament of 13 June 2000 (not yet
published in the Official Journal) and Council Decision of 17 July
2000.

(3) OJ L 374, 31.12.1990, p. 1. Directive as last amended by Commis-

sion Directive 97/65/EC (OJ L 335, 6.12.1997, p. 17).

(4) See Annex VIII, part A.
(5) OJ L 183, 29.6.1989, p. 1.

(5)

(6)

(7)

(8)

(9)

(10)

The list and classification of the biological agents must
be examined regularly and revised on the basis of new
scientific data.

For a number of biological agents details additional to
their classification should be given.

Employers must keep abreast of new developments in
technology with a view to improving the protection of
workers' health and safety.

Preventive measures should be taken for the protection
of the health and safety of workers exposed to biological
agent.

This Directive constitutes a practical aspect of the reali-
sation of the social dimension of the internal market.

to Council Decision 74/325/EEC (6)

Pursuant
the
Advisory Committee on Safety, Hygiene and Health
Protection at Work should be consulted by the Commis-
sion with a view to the formulation of proposals in this
field.
the formulation of
proposals for the Council directives embodied in this
Directive.

It was so consulted over

(11)

This Directive is without prejudice to the obligations of
the Member States concerning the deadlines for transpo-
sition as set out in Annex VIII, Part B,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

GENERAL PROVISIONS

Article 1

Objective

1.
This Directive 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 biolog-
ical agents at work.

It lays down particular minimum provisions in this area.

(6) OJ L 185, 9.7.1974, p. 15; Decision as last amended by the 1994

Act of Accession.

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Directive 89/391/EEC shall apply fully to the whole area
2.
referred to in paragraph 1, without prejudice to more stringent
and/or specific provisions contained in this Directive.

This Directive shall apply without prejudice to the provi-
3.
sions of Council Directive 90/219/EEC (1) and of Council
Directive 90/220/EEC (2).

Article 2

Definitions

For the purpose of this Directive:

(a) ‘biological agents’ shall mean micro-organisms,

including
those which have been genetically modified, cell cultures
and human endoparasites, which may be able to provoke
any infection, allergy or toxicity;

(b) ‘micro-organism’

shall mean a microbiological entity,
cellular or non-cellular, capable of replication or of trans-
ferring genetic material;

(c) ‘cell culture’ shall mean the in-vitro growth of cells derived

from multicellular organisms.

‘Biological agents’ shall be classified into four risk groups,
according to their level of risk of infection:

In the case of any activity likely to involve a risk of
2.
exposure to biological agents, the nature, degree and duration
of workers' exposure must be determined in order to make it
possible to assess any risk to the workers' health or safety and
to lay down the measures to be taken.

In the case of activities involving exposure to several groups of
biological agents, the risk shall be assessed on the basis of the
danger presented by all hazardous biological agents present.

The assessment must be renewed regularly and in any event
when any change occurs in the conditions which may affect
workers' exposure to biological agents.

The employer must supply the competent authorities, at their
request, with the information used for making the assessment.

3.
The assessment referred to in paragraph 2 shall be
conducted on the basis of all available information including:

(a) classification of biological agents which are or may be a
hazard to human health, as referred to in Article 18;

(b) recommendations from a competent authority which indi-
cate that the biological agent should be controlled in order
to protect workers' health when workers are or may be
exposed to such a biological agent as a result of their work;

1. group 1 biological agent means one that is unlikely to cause

human disease:

(c) information on diseases which may be contracted as a

result of the work of the workers;

2. group 2 biological agent means one that can cause human
disease and might be a hazard to workers; it is unlikely to
spread to the community; there is usually effective prophy-
laxis or treatment available;

3. group 3 biological agent means one that can cause severe
human disease and present a serious hazard to workers; it
may present a risk of spreading to the community, but there
is usually effective prophylaxis or treatment available;

4. group 4 biological agent means one that causes severe
human disease and is a serious hazard to workers; it may
present a high risk of spreading to the community; there is
usually no effective prophylaxis or treatment available.

Article 3

Scope — Determination and assessment of risks

This Directive shall apply to activities in which workers
1.
are or are potentially exposed to biological agents as a result of
their work.

(1) Council Directive 90/219/EEC of 23 April 1990 on the contained
use of genetically modified micro-organisms (OJ L 117, 8.5.1990,
p. 1). Directive as last amended by Directive 98/81/EC (OJ L 330,
5.12.1998, p. 13).

(2) Council Directive 90/220/EEC of 23 April 1990 on the deliberate
release into the environment of genetically modified organisms (OJ
L 117, 8.5.1990, p. 15). Directive as last amended by Directive 97/
35/EC (OJ L 169, 27.6.1997, p. 72).

(d) potential allergenic or toxigenic effects as a result of the

work of the workers;

(e) knowledge of a disease from which a worker is found to be
suffering and which has a direct connection with his work.

Article 4

Application of the various Articles in relation to assess-
ment of risks

1.
If the results of the assessment referred to in Article 3
show that the exposure and/or potential exposure is to a group
1 biological agent, with no identifiable health risk to workers,
Articles 5 to 17 and Article 19 shall not apply.

However, point 1 of Annex VI should be observed.

2.
If the results of the assessment referred to in Article 3
show that the activity does not involve a deliberate intention to
work with or use a biological agent but may result in the
workers' being exposed to a biological agent, as in the course
of the activities for which an indicative list is given in Annex I,
Articles 5, 7, 8, 10, 11, 12, 13 and 14 shall apply unless the
results of the assessment referred to in Article 3 show them to
be unnecessary.

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CHAPTER II

Article 7

EMPLOYERS' OBLIGATIONS

Article 5

Replacement

The employer shall avoid the use of a harmful biological agent
if the nature of the activity so permits, by replacing it with a
is not
biological agent which, under its conditions of use,
dangerous or is less dangerous to workers' health, as the case
may be,

in the present state of knowledge.

Article 6

Reduction of risks

1. Where the results of the assessment referred to in Article
3 reveal a risk to workers' health or safety, workers' exposure
must be prevented.

2. Where this is not technically practicable, having regard to
the activity and the risk assessment referred to in Article 3, the
risk of exposure must be reduced to as low a level as necessary
in order to protect adequately the health and safety of the
in particular by the following measures
workers concerned,
which are to be applied in the light of the results of the
assessment referred to in Article 3:

(a) keeping as low as possible the number of workers exposed

or likely to be exposed;

(b) design of work processes and engineering control measures
so as to avoid or minimise the release of biological agents
into the place of work;

(c) collective protection measures and/or, where exposure
cannot be avoided by other means, individual protection
measures;

(d) hygiene measures compatible with the aim of the pre-
vention or reduction of the accidental transfer or release of
a biological agent from the workplace;

(e) use of the biohazard sign depicted in Annex II and other

relevant warning signs;

(f) drawing up plans to deal with accidents involving bio-

logical agents;

(g) testing, where it is necessary and technically possible, for
the presence, outside the primary physical confinement, of
biological agents used at work;

(h) means for safe collection, storage and disposal of waste by
secure and identifiable

workers
containers, after suitable treatment where appropriate;

including the use of

Information for the competent authority

1. Where the results of the assessment referred to in Article
3 reveal risk to workers' health or safety, employers shall, when
requested, make available to the competent authority appro-
priate information on:

(a) the results of the assessment;

(b) the activities in which workers have been exposed or may

have been exposed to biological agents;

(c) the number of workers exposed;

(d) the name and capabilities of the person responsible for

safety and health at work;

(e) the protective and preventive measures taken,

including

working procedures and methods;

(f) an emergency plan for the protection of workers from
exposure to group 3 or a group 4 biological agent which
might result from a loss of physical containment.

shall

Employers

2.
competent
authority of any accident or incident which may have resulted
in the release of a biological agent and which could cause
severe human infection and/or illness.

inform forthwith the

3.
The list referred to in Article 11 and the medical record
referred to in Article 14 shall be made available to the
competent authority in cases where the undertaking ceases
activity,

in accordance with national

laws and/or practice.

Article 8

Hygiene and individual protection

Employers shall be obliged, in the case of all activities for
1.
which there is a risk to the health or safety of workers due to
work with biological agents, to take appropriate measures to
ensure that:

(a) workers do not eat or drink in working areas where there is

a risk of contamination by biological agents;

(b) workers are provided with appropriate protective clothing

or other appropriate special clothing;

(c) workers are provided with appropriate and adequate
washing and toilet facilities, which may include eye washes
and/or skin antiseptics;

(d) any necessary protective equipment is:

— properly stored in a well-defined place,

— checked and cleaned if possible before, and in any case

after, each use,

— is repaired, where defective, or is replaced before further

use;

(i) arrangements for the safe handling and transport of bio-

(e) procedures

are

specified

for

taking, handling

and

logical agents within the workplace.

processing samples of human or animal origin.

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including
2. Working clothes and protective equipment,
protective clothing referred to in paragraph 1, which may be
contaminated by biological agents, must be removed on
leaving the working area and, before taking the measures
referred to in the second subparagraph, kept separately from
other clothing.

The employer must ensure that such clothing and protective
equipment
if necessary,
is decontaminated and cleaned or,
destroyed.

3. Workers may not be charged for the cost of the measures
referred to in paragraphs 1 and 2.

Article 9

Information and training of workers

1.
Appropriate measures shall be taken by the employer to
ensure that workers and/or any workers' representatives in the
undertaking or establishment receive sufficient and appropriate
training, on the basis of all available information, in particular
in the form of information and instructions, concerning:

(a) potential risks to health;

(b) precautions to be taken to prevent exposure;

(c) hygiene requirements;

(d) wearing and use of protective equipment and clothing;

(e) steps to be taken by workers in the case of incidents and to

prevent incidents.

2.

The training shall be:

(a) given at the beginning of work involving contact with

biological agents,

(b) adapted to take account of new or changed risks, and

(c) repeated periodically if necessary.

Article 10

inform the workers and/or any
In addition, employers shall
workers' representatives in the undertaking or establishment 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.

4.
Each worker shall have access to the information on the
list referred to in Article 11 which relates to him personally.

in the
5. Workers and/or any workers'
undertaking or establishment shall have access to anonymous
collective information.

representatives

6.
Employers shall provide workers and/or their representa-
tives, at their requst, with the information provided for in
Article 7(1).

Article 11

List of exposed workers

Employers shall keep a list of workers exposed to group
1.
3 and/or group 4 biological agents, indicating the type of work
done and, whenever possible, the biological agent to which
they have been exposed, as well as records of exposures, acci-
dents and incidents, as appropriate.

2.
The list referred to in paragraph 1 shall be kept for at
least 10 years following the end of exposure, in accordance
with national

laws and/or practice.

In the case of those exposures which may result in infections:

(a) with biological agents known to be capable of establishing

persistent or latent infections;

(b) that, in the light of present knowledge, are undiagnosable

until

illness develops many years later;

(c) that have particularly long incubation periods before illness

develops;

(d) that result in illnesses which recrudesce at times over a

long period despite treatment, or

Worker information in particular cases

(e) that may have serious long-term sequelae,

Employers shall provide written instructions at the work-
1.
place and,
if appropriate, display notices which shall, as a
minimum, include the procedure to be followed in the case of:

(a) a serious accident or incident involving the handling of a

biological agent;

(b) handling a group 4 biological agent.

2. Workers shall immediately report any accident or inci-
dent involving the handling of a biological agent to the person
in charge, or to the person responsible for safety and health at
work.

the list shall be kept for an appropriately longer time up to 40
years following the last known exposure.

3.
The doctor referred to in Article 14 and/or the competent
authority for health and safety at work, and any other person
responsible for health and safety at work, shall have access to
the list referred to in paragraph 1.

Article 12

Consultation and participation of workers

3.
Employers shall inform forthwith the workers and/or any
workers' representatives of any accident or incident which may
have resulted in the release of a biological agent and which
could cause severe human infection and/or illness.

Consultation and participation of workers and/or their repre-
sentatives in connection with matters covered by this Directive
shall take place in accordance with Article 11 of Directive
89/391/EEC.

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Article 13

Notification to the competent authority

Prior notification shall be made to the competent

1.
authority of the use for the first time of:

(a) group 2 biological agents;

(b) group 3 biological agents;

(c) group 4 biological agents.

The notification shall be made at least 30 days before the
commencement of the work.

Subject to paragraph 2, prior notification shall also be made of
the use for the first time of each subsequent group 4 biological
agent and of any subsequent new group 3 biological agent
where the employer himself provisionally classifies that bio-
logical agent.

2.
Laboratories providing a diagnostic service in relation to
group 4 biological agents shall be required only to make an
initial notification of their intention.

3.
Renotification must take place in any case where there
are substantial changes of importance to safety or health at
work to processes and/or procedures which render the noti-
fication out of date.

The notification referred to in paragraphs 1, 2 and 3 shall

4.
include:

(a) the name and address of the undertaking and/or establish-

ment;

(b) the name and capabilities of the person responsible for

safety and health at work;

(c) the results of the assessment referred to in Article 3;

(d) the species of the biological agent;

The assessment referred to in Article 3 should identify
3.
those workers for whom special protective measures may be
required.

When necessary, effective vaccines should be made available
for those workers who are not already immune to the bio-
logical agent to which they are exposed or are likely to be
exposed.

When employers make vaccines available, they should take
account of the recommended code of practice set out in Annex
VII.

If a worker is found to be suffering from an infection and/or
illness which is suspected to be the result of exposure, the
doctor or authority responsible for health surveillance of
workers shall offer such surveillance to other workers who
have been similarly exposed.

In that event, a reassessment of the risk of exposure shall be
carried out in accordance with Article 3.

In cases where health surveillance is carried out, an indi-
least 10 years
in accordance with national

4.
vidual medical record shall be kept
following the end of exposure,
laws and practice.

for at

In the special cases referred to in Article 11(2) second subpara-
graph, an individual medical record shall be kept for an appro-
priately longer time up to 40 years following the last known
exposure.

5.
The doctor or authority responsible for health surveil-
lance shall propose any protective or preventive measures to be
taken in respect of any individual worker.

6.
Information and advice must be given to workers
regarding any health surveillance which they may undergo
following the end of exposure.

(e) the protection and preventive measures that are envisaged.

7.

In accordance with national

laws and/or practice:

CHAPTER III

MISCELLANEOUS PROVISIONS

Article 14

Health surveillance

The Member States shall establish,

in accordance with
1.
national laws and practice, arrangements for carrying out rele-
vant health surveillance of workers for whom the results of the
assessment referred to in Article 3 reveal a risk to health or
safety.

2.
The arrangements referred to in paragraph 1 shall be
such that each worker shall be able to undergo, if appropriate,
relevant health surveillance:

(a) prior to exposure;

(b) at regular intervals thereafter.

Those arrangements shall be such that it is directly possible to
implement individual and occupational hygiene measures.

(a) workers shall have access to the results of

the health

surveillance which concern them, and

(b) the workers concerned or the employer may request a

review of the results of the health surveillance.

Practical recommendations for the health surveillance of

8.
workers are given in Annex IV.

9.
All cases of diseases or death identified in accordance
with national laws and/or practice as resulting from occupa-
tional exposure to biological agents shall be notified to the
competent authority.

Article 15

Health and veterinary care facilities other than diagnostic
laboratories

For the purpose of the assessment referred to in Article 3,

1.
particular attention should be paid to:

(a) uncertainties about the presence of biological agents in
human patients or animals and the materials and speci-
ments taken from them;

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(b) the hazard represented by biological agents known or
suspected to be present in human patients or animals and
materials and specimens taken from them;

they are necessary, except where guidelines provided by the
competent national authorities show that, in certain cases,
a lower containment level

is appropriate.

(c) the risks posed by the nature of the work.

2.
Appropriate measures shall be taken in health and veter-
inary care facilities in order to protect the health and safety of
the workers concerned.

The measures to be taken shall

include in particular:

(a) specifying appropriate decontamination and disinfection

procedures, and

(b) implementing procedures enabling contaminated waste to

be handled and disposed of without risk.

In isolation facilities where there are human patients or
3.
animals who are, or who are suspected of being, infected with
group 3 or group 4 biological agents, containment measures
shall be selected from those in Annex V column A, in order to
minimise the risk of infection.

The following measures concerning industrial processes

2.
using group 2, 3 or 4 biological agents must be taken:

(a) The containment principles set out in the second subpara-
graph of paragraph 1(b) should also apply to industrial
processes on the basis of the practical measures and appro-
priate procedures given in Annex VI.

(b) In accordance with the assessment of the risk linked to the
use of group 2, 3 or 4 biological agents, the competent
authorities may decide on appropriate measures which
must be applied to the industrial use of such biological
agents.

For all activities covered by paragraphs 1 and 2 where it
3.
has not been possible to carry out a conclusive assessment of a
biological agent but concerning which it appears that the use
envisaged might involve a serious health risk for workers,
activities may only be carried out in workplaces where the
containment level corresponds at least to level 3.

Article 16

Special measures for industrial processes, laboratories and
animal rooms

The following measures must be taken in laboratories,
1.
including diagnostic laboratories, and in rooms for laboratory
animals which have been deliberately infected with group 2, 3
or 4 biological agents or which are or are suspected to be
carriers of such agents.

(a) Laboratories

carrying out work which involves

the
handling of group 2, 3 or 4 biological agents for research,
development, teaching or diagnostic purposes shall deter-
mine the containment measures in accordance with Annex
V,

in order to minimise the risk of infection.

(b) Following the assessment referred to in Article 3, measures
shall be determined in accordance with Annex V, after
level required for the
fixing the physical containment
biological agents according to the degree of risk.

Activities involving the handling of a biological agent must
be carried out:

— only in working areas corresponding to at least contain-

ment level 2, for a group 2 biological agent,

— only in working areas corresponding to at least contain-

ment level 3, for a group 3 biological agent,

— only in working areas corresponding to at least contain-

ment level 4, for a group 4 biological agent.

(c) Laboratories handling materials in respect of which there
exist uncertainties about the presence of biological agents
which may cause human disease but which do not have as
their aim working with biological agents as such (i.e. culti-
vating or concentrating them) should adopt containment
level 2 at least. Containment levels 3 or 4 must be used,
when appropriate, where it is known or it is suspected that

Article 17

Use of data

The Commission shall have access to the use made by the
competent national authorities of the information referred to in
Article 14(9).

Article 18

Classification of biological agents

1.
Community classification shall be on the basis of the
definitions in the second paragraph of Article 2, points 2 to 4
(groups 2 to 4).

2.
Pending Community classification Member States shall
classify biologial agents that are or may be a hazard to human
health on the basis of the definition in the second paragraph of
Article 2, points 2 to 4 (groups 2 to 4).

3.
If the biological agent tobe assessed cannot be classified
clearly in one of the groups defined in the second paragraph of
Article 2, it must be classified in the highest risk group among
the alternatives.

Article 19

Annexes

Purely technical adjustments to the Annexes in the light of
technical progress, changes in international regulations or spec-
ifications and new findings in the field of biological agents shall
be adopted in accordance with the procedure laid down in
Article 17 of Directive 89/391/EEC.

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Article 20

Notifying the Commission

Article 22

Entry into force

Member States shall communicate to the Commission the
provisions of national
in the field
governed by this Directive.

law which they adopt

This Directive enters into force on the twentieth day following
its publication in the Official Journal of the European Communities.

Article 21

Repeal

Directive 90/679/EEC, amended by the Directives referred to in
Annex VIII, part A is repealed, without prejudice to the obliga-
tions of the Member States in respect of the deadlines for
transposition laid down in Annex VIII, part B.

References to the repealed Directive shall be construed as refer-
ences to this Directive and shall be correlated in accordance
with the correlation table set out in Annex IX.

Article 23

Addresses

This Directive is addressed to the Member States.

Done at Brussels, 18 September 2000.

For the European Parliament

For the Council

The President

N. FONTAINE

The President

H. VÉDRINE

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ANNEX I

INDICATIVE LIST OF ACTIVITIES

(Article 4(2))

1. Work in food production plants.

2. Work in agriculture.

3. Work activities where there is contact with animals and/or products of animal origin.

4. Work in healthcare,

including isolation and post-mortem units.

5. Work in clinical, veterinary and diagnostic laboratories, excluding diagnostic microbiological

laboratories.

6. Work in refuse disposal plants.

7. Work in sewage purification installations.

ANNEX II

BIOHAZARD SIGN

(Article 6(2)(e))

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ANNEX III

COMMUNITY CLASSIFICATION

Article 2, second paragraph, and Article 18

INTRODUCTORY NOTES

1. In line with the scope of the Directive, only agents which are known to infect humans are to be included in the

classified list.

Where appropriate,

indicators are given of the toxic and allergic potential of these agents.

Animal and plant pathogens which are known not to affect man are excluded.

In drawing up this list of classified biological agents consideration has not been given to genetically modified
micro-organisms.

2. The list of classified agents is based on the effect of those agents on healthy workers.

No specific account is taken of particular effects on those whose susceptibility may be affected for one or other
reason such as pre-existing disease, medication, compromised immunity, pregnancy or breast feeding.

Additional risk to such workers should be considered as part of the risk assessment required by the Directive.

In certain industrial processes, certain laboratory work or certain work with animals involving actual or potential
exposure to biological agents of groups 3 or 4, any technical precautions taken must comply with Article 16 of the
Directive.

3. Biological agents which have not been classified for inclusion in groups 2 to 4 of the list are not implicitly classified

in group 1.

For agents where more than one species is known to be pathogenic to man, the list will include those species which
are known to be the most frequently responsible for diseases, together with a more general reference to the fact that
other species of the same genus may affect health.

When a whole genus is mentioned in the classified list of biological agents, it is implicit that the species and strains
known to be non-pathogenic are excluded.

4. Where a strain is attenuated or has lost known virulence genes, then the containment required by the classification of

its parent strain need not necessarily apply, subject to assessment appropriate for risk in the workplace.

This is the case, for example, when such a strain is to be used as a product or part of a product for prophylactic or
therapeutic purposes.

5. The nomenclature of classified agents used to establish this list reflects and is in conformity with the latest
international agreements of the taxonomy and nomenclature of agents at the time the list was prepared.

6. The list of classified biological agents reflects the state of knowledge at the time that it was devised.

It will be updated as soon as it no longer reflects the latest state of knowledge.

7. Member States are to ensure that all viruses which have already been isolated in humains and which have not been
assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof
that they are unlikely to cause disease in humans.

8. Certain biological agents classified in group 3 which are indicated in the appended list by two asterisks (**), may
present a limited risk of infection for workers because they are not normally infectious by the airborne route.

Member States shall assess the containment measures to be applied to such agents, taking account of the nature of
specific activities in question and of the quantity of the agent involved, with a view to determining whether, in
particular circumstances, some of these measures may be dispensed with.

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9. The requirements as to containment consequent on the classification of parasites apply only to stages in the life cycle

of the parasite in which it is liable to be infectious to humans at the workplace.

10. This list also gives a separate indication in cases where the biological agents are likely to cause allergic or toxic
reactions, where an effective vaccine is available, or wher it is advisable to keep a list of exposed workers for more
than 10 years.

These indications are shown by the following letters:

A:

D:

T:

V:

Possible allergic effects

List of workers exposed to this biological agent to be kept for more than 10 years after the end of last known
exposure

Toxin production

Effective vaccine available

The application of preventive vaccination should take account of the code of practice given in Annex VII.

17.10.2000

EN

Official Journal of the European Communities

L 262/31

BACTERIA

and similar organisms

NB: For biological agents appearing on this list, ‘spp.’ refers to other species which are known pathogens in humans.

Biological agent

Classification

Notes

Actinobacillus actinomycetemcomitans

Actinomadura madurae

Actinomadura pelletieri

Actinomyces gerencseriae

Actinomyces israelii

Actinomyces pyogenes

Actinomyces spp.

Arcanobacterium haemolyticum (Corynebacterium haenolyticum)

Bacillus anthracis

Bacteroides fragilis

Bartonella bacillifonnis

Bartonella quintana (Rochalimaea quintana)

Bartonella (Rochalinea) spp.

Bordetella bronchiseptica

Bordetella parapertussis

Bordetella pertussis

Borrelia burgdorferi

Borrelia duttonii

Borrelia recurrentis

Borrelia spp.

Brucella abortus

Brucella canis

Brucella melitensis

Brucella suis

Burkholderia mallei (Pseudomonas mallei)

Burkholderia pseudomallei (Pseudomonas pseudomallei)

Campylobacter fetus

Campylobacter jejuni

Campylobacter spp.

Cardiobacterium hominis

Chlamydia pneumoniae

Chlamydia trachomatis

Chlamydia psittaci (avian strains)

Chlamydia psittaci (other strains)

Clostridium botulinum

Clostridium perfringens

Clostridium tetani

Clostridium spp.

Corynebacterium diphtheriae

Corynebacterium minutissimum

Corynebacterium pseudotuberculosis

Corynebacterium spp.

Coxiella burnetii

Edwardsiella tarda

Ehrlichia sennetsu (Rickettsia sennetsu)

Ehrlichia spp.

Eikenella corrodens

2

2

2

2

2

2

2

2

3

2

2

2

2

2

2

2

2

2

2

2

3

3

3

3

3

3

2

2

2

2

2

2

3

2

2

2

2

2

2

2

2

2

3

2

2

2

2

V

T

T, V

T, V

L 262/32

EN

Official Journal of the European Communities

17.10.2000

Biological agent

Classification

Notes

Enterobacter aerogenes/cloacae

Enterobacter spp.

Enterococcus spp.

Erysipelothrix rhusiopathiae

Escherichia coli (with the exception of non-pathogenic strains)

2

2

2

2

2

Escherichia coli, verocytotoxigenic strains (e.g. O157:H7 or O103)

3 (**)

Flavobacterium meningosepticum

Fluoribacter bozemanae (Legionella)

Francisella tularensis (Type A)

Francisella tularensis (Type B)

Fusobacterium necrophorum

Gardnerella vaginalis

Haemophilus ducreyi

Haemophilus influenzae

Haemophilus spp.

Helicobacter pylori

Klebsiella oxytoca

Klebsiella pneumoniae

Klebsiella spp.

Legionella pneumophila

Legionella spp.

Leptospira interrogans (all serovars)

Listeria monocytogenes

Listeria ivanovii

Morganella morganii

Mycobacterium africanum

Mycobacterium avium/intracellulare

Mycobacterium bovis (except BCG strain)

Mycobacterium chelonae

Mycobacterium fortuitum

Mycobacterium kansasii

Mycobacterium leprae

Mycobacterium malmoense

Mycobacterium marinum

Mycobacterium microti

Mycobacterium paratuberculosis

Mycobacterium scrofulaceum

Mycobacterium simiae

Mycobacterium szulgai

Mycobacterium tuberculosis

Mycobacterium ulcerans

Mycobacterium xenopi

Mycoplasma caviae

Mycoplasma hominis

Mycoplasma pneumoniae

Neisseria gonorrhoeae

Neisseria meningitidis

Nocardia asteroides

Nocardia brasiliensis

Nocardia farcinica

Nocardia nova

2

2

3

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

3

2

3

2

2

2

3

2

2

3 (**)

2

2

2

2

3

3 (**)

2

2

2

2

2

2

2

2

2

2

V

V

V

V

17.10.2000

EN

Official Journal of the European Communities

L 262/33

Biological agent

Classification

Notes

Nocardia otitidiscaviarum
Pasteurella multocida
Pasteurella spp.
Peptostreptococcus anaerobius
Plesiomonas shigelloides
Porphyromonas spp.
Prevotella spp.
Proteus mirabilis
Proteus penneri
Proteus vulgaris
Providencia alcalifaciens
Providencia rettgeri
Providencia spp.
Pseudomonas aeruginosa
Rhodococcus equi
Rickettsia akari
Rickettsia canada
Rickettsia conorii
Rickettsia montana
Rickettsia typhi (Rickettsia mooseri)
Rickettsia prowazekii
Rickettsia rickettsii
Rickettsia tsutsugamushi
Rickettsia spp.
Salmonella arizonae
Salmonella enteritidis
Salmonella typhimurium
Salmonella paratyphi A, B, C
Salmonella typhi
Salmonella (other serovars)
Serpulina spp.
Shigella boydii
Shigella dysenteriae (Type 1)
Shigella dysenteriae, other than Type 1
Shigella flexneri
Shigella sonnei
Staphylococcus aureus
Streptobacillus moniliformis
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus suis
Streptococcus spp.
Treponema carateum
Treponema pallidum
Treponema pertenue
Treponema spp.
Vibrio cholerae (including El Tor)
Vibrio parahaemolyticus
Vibrio spp.
Yersinia enterocolitica
Yersinia pestis
Yersinia pseudotuberculosis
Yersinia spp.

(**) See paragraph 8 of the introductory notes.

2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
3 (**)
3 (**)
3
3 (**)
3
3
3
3
2
2
2
2
2
3 (**)
2
2
2
3 (**)
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
3
2
2

V
V

T

V

L 262/34

EN

Official Journal of the European Communities

17.10.2000

VIRUSES (*)

Biological agent

Classification

Notes

Adenoviridae
Arenaviridae

LCM-Lassa-virus complex (old world arena viruses):

Lassa virus
Lymphocytic (strains)
Lymphocytic choriomeningitis virus (other strains)
Mopeia virus
Other LCM-Lassa complex viruses

Tacaribe-Virus-complex (new world arena viruses):

Guanarito virus
Junin virus
Sabia virus
Machupo virus
Flexal virus
Other Tacaribe complex viruses

Astroviridae
Bunyaviridae

Belgrade (also known as Dobrava)
Bhanja
Bunyamwera virus
Germiston
Oropouche virus
Sin Nombre (formerly Muerto Canyon)
California encephalitis virus
Hantaviruses:

Hantaan (Korean haemorrhagic fever)
Seoul virus
Puumala virus
Prospect Hill virus
Other hantaviruses

Nairoviruses:

Crimean-Congo haemorrhagic fever
Hazara virus

Phleboviruses:

Rift Valley fever
Sandfly fever
Toscana virus
Other bunyaviridae known to be pathogenic

Caliciviridae

Hepatitis E virus
Norwalk virus
Other Caliciviridae

Coronaviridae
Filoviridae

Ebola virus
Marburg virus

Flaviviridae

Australia encephalitis (Murray Valley encephalitis)
Central European tick-borne encephalitis virus
Absettarov
Hanzalova
Hypr
Kumlinge
Dengue virus type 1-4
Hepatitis C virus

2

4
3
2
2
2

4
4
4
4
3
2
2

3
2
2
2
3
3
2

3
3
2
2
2

4
2

3
2
2
2

3 (**)
2
2
2

4
4

3
3 (**)
3
3
3
3
3
3 (**)

V

V

D

17.10.2000

EN

Official Journal of the European Communities

L 262/35

Biological agent

Classification

Notes

Hepatitis G virus
Japanese B encephalitis
Kyasanur Forest
Louping ill
Omsk (a)
Powassan
Rocio
Russian spring-summer encephalitis (TBE) (a)
St Louis encephalitis
Wesselsbron virus
West Nile fever virus
Yellow fever
Other flaviviruses known to be pathogenic

Hepadnaviridae

Hepatitis B virus
Hepatitis D virus (Delta) (b)

Herpesviridae

Cytomegalovirus
Epstein-Barr virus
Herpesvirus simiae (B virus)
Herpes simplex virus types 1 and 2
Herpesvirus varicella-zoster
Human B-lymphotropic virus (HBLV-HHV6)
Human herpes virus 7
Human herpes virus 8

Orthomyxoviridae

Influenza viruses types A, B and C
Tick-borne orthomyxoviridae: Dhori and Thogoto

Papovaviridae

BK and JC viruses
Human papillomaviruses

Paramyxoviridae

Measles virus
Mumps virus
Newcastle disease virus
Parainfluenza viruses types 1 to 4
Respiratory syncytial virus

Parvoviridae

Human parvovirus (B 19)

Picomaviridae

Acute haemorrhagic conjunctivitis virus (AHC)
Coxsackie viruses
Echo viruses
Hepatitis A virus (human enterovirus type 72)
Polioviruses
Rhinoviruses

Poxviridae

Buffalopox virus (e)
Cowpox virus
Elephantpox virus (f)
Milkers' node virus
Molluscum contagiosum virus
Monkeypox virus
Orf virus
Rabbitpox virus (g)
Vaccinia virus
Variola (major and minor) virus

3 (**)
3
3
3 (**)
3
3
3
3
3
3 (**)
3
3
2

3 (**)
3 (**)

2
2
3
2
2
2
2
2

2
2

2
2

2
2
2
2
2

2

2
2
2
2
2
2

2
2
2
2
2
3
2
2
2
4

D
V
V

V

V

V

V, D
V, D

D

V (c)

D (d)
D (d)

V
V

V
V

V

V

L 262/36

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Official Journal of the European Communities

17.10.2000

Biological agent

Classification

Whitepox virus (‘Variola virus’)
Yatapox virus (Tana & Yaba)

Reoviridae

Coltivirus
Human rotaviruses
Orbiviruses
Reuviruses

Retroviridae

Human immunodeficiency viruses
Human T-cell lymphotropic viruses (HTLV), types 1 and 2
SIV (h)
Rhabdoviridae

Rabies virus
Vesicular stomatitis virus

Togaviridae

Alphaviruses

Eastern equine encephalomyelitis
Bebaru virus
Chikungunya virus
Everglades virus
Mayaro virus
Mucambo virus
Ndumu virus
O'nyong-nyong virus
Ross River virus
Semliki Forest virus
Sindbis virus
Tonate virus
Venezuelan equine encephalomyelitis
Western equine encephalomyelitis
Other known alphaviruses

Rubivirus (rubella)

Toroviridae
Unclassified viruses

Equine morbillivirus
Hepatitis viruses not yet identified

Unconventional agents associated with the transmissible spongiform
encephalopathies (TSEs)

Creutzfeldt-Jakob disease
Variant Creutzfeldt-Jakob disease
Bovine spongiform encephalopathy (BSE) and other related animal TSEs (i)
Gerstmann-Sträussler-Scheinker syndrome
Kuru

4
2

2
2
2
2

3 (**)
3 (**)
3 (**)

3 (**)
2

3
2
3 (**)
3 (**)
3
3 (**)
3
2
2
2
2
3 (**)
3
3
2
2
2

4
3 (**)

3 (**)
3 (**)
3 (**)
3 (**)
3 (**)

Notes

V

D
D

V

V

V
V

V

D

D (d)
D (d)
D (d)
D (d)
D (d)

(*) See paragraph 7 of the introductory notes.
(**) See paragraph 8 of the introductory notes.
(a) Tick-borne encephalitis.
(b) Hepatitis D virus is pathogenic in workers only in the presence of simultaneous or secondary infection caused by hepatitis B virus.
Vaccination against hepatitis B virus will therefore protect workers who are not affected by hepatitis B virus against hepatitis D virus
(Delta).

(c) Only for types A and B.
(d) Recommended for work involving direct contact with these agents.
(e) Two viruses are identified: one a buffalopox type and the other a variant of the Vaccinia virus.
(f) Variant of cowpox virus.
(g) Variant of Vaccinia.
(h) At present there is no evidence of disease in humans caused by the other retroviruses of simian origin. As a precaution containment

level 3 is recommended for work with them.

(i) There is no evidence in humans of infections caused by the agents responsible for other animal TSEs. Nevertheless, the containment
measures for agents categorised in risk group 3 (**) are recommended as a precaution for laboratory work, except for laboratory work
relating to an identified agent of scrapie where containment level 2 is sufficient.

17.10.2000

EN

Official Journal of the European Communities

L 262/37

PARASITES

Biological agent

Classification

Notes

Acanthamoeba castellani

Ancylostoma duodenale

Angiostrongylus cantonensis

Angiostrongylus costaricensis

Ascaris lumbricoides

Ascaris suum

Babesia divergens

Babesia microti

Balantidium coli

Brugia malayi

Brugia pahangi

Capillaria philippinensis

Capillaria spp.

Clonorchis sinensis

Clonorchis viverrini

Cryptosporidium parvum

Cryptosporidium spp.

Cyclospora cayetanensis

Dipetalonema streptocerca

Diphyllobothrium latum

Dracunculus medinensis

Echinococcus granulosus

Echinococcus multilocularis

Echinococcus vogeli

Entamoeba histolytica

Fasciola gigantica

Fasciola hepatica

Fasciolopsis buski

Giardia lamblia (Giardia intestinalis)

Hymenolepis diminuta

Hymenolepis nana

Leishmania brasiliensis

Leishmania donovani

Leishmania ethiopica

Leishmania mexicana

Leishmania peruviana

Leishmania tropica

Leishmania major

Leishmania spp.

Loa loa

Mansonella ozzardi

Mansonella perstans

Naegleria fowleri

Necator americanus

Onchocerca volvulus

Opisthorchis felineus

Opisthorchis spp.

Paragonimus westermani

A

A

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

3 (**)

3 (**)

3 (**)

2

2

2

2

2

2

2

3 (**)

3 (**)

2

2

2

2

2

2

2

2

2

3

2

2

2

2

2

L 262/38

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Official Journal of the European Communities

17.10.2000

Biological agent

Classification

Notes

Plasmodium falciparum

Plasmodium spp. (human and simian)

Sarcocystis suihominis

Schistosoma haematobium

Schistosoma intercalatum

Schistosoma japonicum

Schistosoma mansoni

Schistosoma mekongi

Strongyloides stercoralis

Strongyloides spp.

Taenia saginata

Taenia solium

Toxocara canis

Toxoplasma gondii

Trichinella spiralis

Trichuris trichiura

Trypanosoma brucei brucei

Trypanosoma brucei gambiense

Trypanosoma brucei rhodesiense

Trypanosoma cruzi

Wuchereria bancrofti

(**) See paragraph 8 of the introductory notes.

3 (**)

2

2

2

2

2

2

2

2

2

2

3 (**)

2

2

2

2

2

2

3 (**)

3

2

17.10.2000

EN

Official Journal of the European Communities

L 262/39

FUNGI

Biological agent

Classification

Notes

Aspergillus fumigatus

Blastomyces dermatitidis (Ajellomyces dermatitidis)

Candida albicans

Candida tropicalis

Cladophialophora bantiana (formerly: Xylohypha bantiana, Cladosporium

bantianum or trichoides)

Coccidioides inunitis

Cryptococcus neoformans var. neofonnans (Filobasidiella neofonnans var. neofonnans)

Cryptococcus neoformans var. gattii (Filobasidiella bacillispora)

Emmonsia parva var. parva

Emmonsia parva var. crescens

Epidermophyton floccosum

Fonsecaea compacta

Fonsecaea pedrosoi

Histoplasma capsulatum var. capsulatum (Ajellomyces capsulatus)

Histoplasma capsulatum duboisii

Madurella grisea

Madurella mycetomatis

Microsporum spp.

Neotestudina rosatii

Paracoccidioides brasiliensis

Penicillium marneffei

Scedosporium apiospermum (Pseudallescheria boydii)

Scedosporium prolificans (inflatum)

Sporothrix schenckii

Trichophyton rubrum

Trichophyton spp.

2

3

2

2

3

3

2

2

2

2

2

2

2

3

3

2

2

2

2

3

2

2

2

2

2

2

A

A

A

A

A

A

A

A

L 262/40

EN

Official Journal of the European Communities

17.10.2000

ANNEX IV

PRACTICAL RECOMMENDATIONS FOR THE HEALTH SURVEILLANCE OF WORKERS

(Article 14(8))

1. The doctor and/or the authority responsible for the health surveillance of workers exposed to biological agents must

be familiar with the exposure conditions or circumstances of each worker.

2. Health surveillance of workers must be carried out in accordance with the principles and practices of occupational

medicine:

it must include at least the following measures:

— keeping records of a worker's medical and occupational history,
— a personalised assessment of the worker's state of health.
— where appropriate, biological monitoring, as well as detection of early and reversible effects.

Further tests may be decided on for each worker when he is the subject of health surveillance, in the light of the most
recent knowledge available to occupational medicine.

17.10.2000

EN

Official Journal of the European Communities

L 262/41

ANNEX V

INDICATIONS CONCERNING CONTAINMENT MEASURES AND CONTAINMENT LEVELS

(Articles 15(3) and 16(1)(a) and (b))

Preliminary note

The measures contained in this Annex shall be applied according to the nature of the activities, the assessment of risk to
workers, and the nature of the biological agent concerned.

A. Containment measures

B. Containment levels

2

3

4

1. The workplace is to be separated from any other activities in the

No

Recommended

Yes

same building

2. Input air and extract air to the workplace are to be filtered using

No

Yes, on extract air

(HEPA) or likewise

Yes, on input and extract
air

3. Access is to be restricted to nominated workers only

Recommended

Yes

Yes, via airlock

4. The workplace is to be sealable to permit disinfection

5. Specified disinfection procedures

No

Yes

Recommended

Yes

6. The workplace is to be maintained at an air pressure negative to

No

Recommended

atmosphere

7. Efficient vector control, for example rodents and insects

Recommended

8. Surfaces impervious to water and easy to clean

Yes, for bench

9. Surfaces resistant to acids, alkalis, solvents, disinfectants

Recommended

10. Safe storage of a biological agent

Yes

Yes

Yes,
floor

Yes

Yes

Yes

Yes

Yes

Yes

11. An observation window, or, alternative, is to be present, so that

Recommended

Recommended

occupants can be seen

12. A laboratory is to contain own equipment

No

Recommended

13. Infected material

including any animal
safety cabinet or isolation or other suitable containment

is to be handled in a

Where appropriate

Yes, where infection is
by airborne route

Yes

Yes, secure storage

Yes

Yes

Yes

for bench and

for bench, walls,

Yes,
floor and ceiling

14. Incinerator for disposal of animal carcases

Recommended

Yes (available)

Yes, on site

L 262/42

EN

Official Journal of the European Communities

17.10.2000

ANNEX VI

CONTAINMENT FOR INDUSTRIAL PROCESSES

(Article 4(1) and Article 16(2)(a))

Group 1 biological agents

For work with group 1 biological agents including life attenuated vaccines, the principles of good occupational safety and
hygiene should be observed.

Groups 2, 3 and 4 biological agents

It may be appropriate to select and combine containment requirements from different categories below on the basis of a
risk assessment related to any particular process or part of a process.

A. Containment measures

B. Containment levels

2

3

4

1. Viable organisms should be handled in a system which physi-

yes

yes

yes

cally separates the process from the environment

2. Exhaust gases from the closed system should be treated so as to: minimise release

prevent release

prevent release

3. Sample collection, addition of materials to a closed system and
transfer of viable organisms to another closed system, should be
performed so as to:

minimise release

prevent release

prevent release

4. Bulk culture fluids should not be removed from the closed

system unless the viable organisms have been:

Inactivated by validated
means

Inactivated by validated
chemical or physical
means

Inactivated by validated
chemical
physical
or
means

5. Seals should be designed so as to:

minimise release

prevent release

prevent release

6. Closed systems should be located within a controlled area

optional

optional

yes, and purpose-built

(a) Biohazard signs should be posted

optional

(b) Access should be restricted to nominated personnel only

optional

(c) Personnel should wear protective clothing

yes, work clothing

(d) Decontamination and washing facilities should be provided

yes

for personnel

(e) Personnel should shower before leaving the controlled area

(f) Effluent from sinks and showers should be collected and

inactivated before release

no

no

(g) The controlled area should be adequately ventilated to mini-

optional

mise air contamination

(h) The controlled area should be maintained at an air pressure

no

negative to atmosphere

(i)

Input air and extract air to the contolled area should be
HEPA filtered

no

(j) The controlled area should be designed to contain spillage of

no

the entire contents of the closed system

(k) The controlled area should be sealable to permit fumigation

no

yes

yes

yes

yes

optional

optional

optional

optional

optional

optional

optional

yes

yes, via an airlock

a complete change

yes

yes

yes

yes

yes

yes

yes

yes

(l) Effluent treatment before final discharge.

Inactivated by validated
means

Inactivated by validated
chemical or physical
means

Inactivated by validated
chemical
physical
or
means

17.10.2000

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Official Journal of the European Communities

L 262/43

ANNEX VII

RECOMMENDED CODE OF PRACTICE ON VACCINATION

(Article 14(3))

1. If the assessment referred to in Article 3(2) reveals that there is a risk to the health and safety of workers due to their
exposure to biological agents for which effective vaccines exist, their employers should offer them vaccination.

2. Vaccination should be carried out in accordance with national

law and/or practice.

Workers should be informed of the benefits and drawbacks of both vaccination and non-vaccination.

3. Vaccination must be offered free of charge to workers.

4. A vaccination certificate may be drawn up which should be made available to the worker concerned and, on request,

to the competent authorities.

ANNEX VIII

PART A

R e p e a l e d D i r e c t i v e w i t h i t s s u c c e s s i v e a m e n d m e n t s

(referred to in Article 21)

Council Directive 90/679/EEC (OJ L 374, 31.12.1990, p. 1)

Council Directive 93/88/EEC (OJ L 268, 29.10.1993, p. 71)

Commission Directive 95/30/EC (OJ L 155, 6.7.1995, p. 41)

Commission Directive 97/59/EC (OJ L 282, 15.10.1997, p. 33)

Commission Directive 97/65/EC (OJ L 335, 6.12.1997, p. 17)

PART B

D e a d l i n e s f o r

t r a n s p o s i t i o n i n t o n a t i o n a l

l a w

(referred to in Article 21)

Directive

Deadline for transposition

90/679/EEC

93/88/EEC

95/30/EC

97/59/EC

97/65/EC

28 November 1993

30 April 1994

30 November 1996

31 March 1998

30 June 1998

L 262/44

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Official Journal of the European Communities

17.10.2000

ANNEX IX

CORRELATION TABLE

Directive 90/679/EEC

This Directive

Article 1

Article 2, point (a)

Article 2, point (b)

Article 2, point (c)

Article 2, point (d)

Article 3(1)

Article 3(2)(a)

Article 3(2)(b)

Article 3(2)(c)

Article 3(2)(d)

Article 3(3), first indent

Article 3(3), second indent

Article 3(3), third indent

Article 3(3), fourth indent

Article 3(3), fifth indent

Article 4

Article 5

Article 6

Article 7(1), first indent

Article 7(1), second indent

Article 7(1), third indent

Article 7(1), fourth indent

Article 7(1), fifth indent

Article 7(1), sixth indent

Article 7(2)

Article 7(3)

Article 8(1)(a) to (e)

Article 8(2)(a)

Article 8(2)(b)

Article 8(3)

Article 9(1)(a) to (e)

Article 9(2), first indent

Article 9(2), second indent

Article 9(2), third indent

Article 10(1), first indent

Article 10(1), second indent

Article 10(2) to (6)

Article 11(1)

Article 1

Article 2, first paragraph, point (a)

Article 2, first paragraph, point (b)

Article 2, first paragraph, point (c)

Article 2, second paragraph

Article 3(1)

Article 3(2), first subparagraph

Article 3(2), second subparagraph

Article 3(2), third subparagraph

Article 3(2), fourth subparagraph

Article 3(3)(a)

Article 3(3)(b)

Article 3(3)(c)

Article 3(3)(d)

Article 3(3)(e)

Article 4

Article 5

Article 6

Article 7(1)(a)

Article 7(1)(b)

Article 7(1)(c)

Article 7(1)(d)

Article 7(1)(e)

Article 7(1)(f)

Article 7(2)

Article 7(3)

Article 8(1)(a) to (e)

Article 8(2), first subparagraph

Article 8(2), second subparagraph

Article 8(3)

Article 9(1)(a) to (e)

Article 9(2)(a)

Article 9(2)(b)

Article 9(2)(c)

Article 10(1)(a)

Article 10(1)(b)

Article 10(2) to (6)

Article 11(1)

Article 11(2), second subparagraph, first indent

Article 11(2), second subparagraph, (a)

Article 11(2), second subparagraph, second indent

Article 11(2), second subparagraph, (b)

Article 11(2), second subparagraph, third indent

Article 11(2), second subparagraph, (c)

Article 11(2), second subparagraph, fourth indent

Article 11(2), second subparagraph, (d)

Article 11(2), second subparagraph, fifth indent

Article 11(2), second subparagraph, (e)

Article 11(3)

Article 12

Article 13(1), first indent

Article 13(1), second indent

Article 11(3)

Article 12

Article 13(1)(a)

Article 13(1)(b)

17.10.2000

EN

Official Journal of the European Communities

L 262/45

Directive 90/679/EEC

This Directive

Article 13(1), third indent

Article 13(2) to (4)

Article 14(1)

Article 14(2), first indent

Article 14(2), second indent

Article 14(3) to (6)

Article 14(7), first indent

Article 14(7), second indent

Article 14(8)

Article 14(9)

Article 15

Article 16(1)

Article 16(2)(a)

Article 16(2)(b)

Article 16(2)(c)

Article 17

Article 18(1)

Article 18(2)

Article 18(3)

Article 18(4)

Article 19

Article 20(1)

Article 20(2)

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—

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Annex I

Annex II

Annex III

Annex IV

Annex V

Annex VI

Annex VII

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—

Article 13(1)(c)

Article 13(2) to (4)

Article 14(1)

Article 14(2)(a)

Article 14(2)(b)

Article 14(3) to (6)

Article 14(7)(a)

Article 14(7)(b)

Article 14(8)

Article 14(9)

Article 15

Article 16(1)

Article 16(2)(a)

Article 16(2)(b)

Article 16(3)

Article 17

—

Article 18(1)

Article 18(2)

Article 18(3)

Article 19

—

Article 20

Article 21

Article 22

Article 23

Annex I

Annex II

Annex III

Annex IV

Annex V

Annex VI

Annex VII

Annex VIII

Annex IX