90/394/EEC - - - I
1This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
COUNCIL DIRECTIVE
of 28 June 1990
on the protection of workers from the risks related to exposure to carcinogens at work (Sixth
individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC)
(90/394/EEC)
(OJ No L 196, 26. 7. 1990, p. 1)
Amended by:
Official Journal
No page date
Council Directive 97/42/EC of 27 June 1997 L 179 4 8. 7. 1997
90/394/EEC - - - I
ICOUNCIL DIRECTIVE
of 28 June 1990
on the protection of workers from the risks related to exposure to carcinogens at work (Sixth
individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC)
(90/394/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the T reaty establishing the EuropeanEconomic Community, and in particular Article 118a
thereof,
Having regard to the proposal from the Commission (
1),
drawn up following consultation with the Advisory Com-
mittee on Safety, Hygiene and Health Protection at Work,
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social
Committee (3),
Whereas Article 118a of the T reaty provides that the
Council is to adopt, by means of Directives, minimum re-
quirements in order to encourage improvements, especially
in the working environment, so as to guarantee better
protection of the health and safety of workers;
Whereas, according to that Article, such directives must
avoid imposing administrative, financial and legal con-
straint in a way which would hold back the creation and
development of small and medium-sized undertakings;
Whereas the Council resolution of 27 February 1984 on a
second action programme of the European Communities
on safety and health at work (4)p r o v i d e sf o rt h ed e v e l o p -
ment of protective measures for workers exposed to carci-
nogens;
Whereas the Commission communication on its pro-
gramme concerning safety, hygiene and health at work (5)
provides for the adoption of Directives to guarantee the
health and safety of workers;
Whereas compliance with the minimum requirements de-
signed to guarantee a better standard of health and safety
as regards the protection of workers from the risks related
to exposure to carcinogens at work is essential to ensure
the health and safety of workers;
(1) OJ No C 34, 8. 2. 1988, p. 9.
(2) OJ No C 158, 26. 6. 1989, p. 121 and
OJ No C 149, 18. 6. 1990.
(3) OJ No C 208, 8. 8. 1988, p. 43.
(4) OJ No C 67, 8. 3. 1984, p. 2.
(5) OJ No C 28, 3. 2. 1988, p. 1.
90/394/EEC - - - I
IIWhereas 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 measures to en-
courage improvements in the health and safety of workers
at work (1) ; whereas therefore the provisions of that Di-
rective are fully applicable to the exposure of workers to
carcinogens, without prejudice to more stringent and/or
specific provisions contained in this Directive;
Whereas Council Directive 67/548/EEC of 27 June 1967
on the approximation of laws, regulations and administra-
tive provisions relating to the classification, packaging and
labelling of dangerous substances (2), as last amended by
Directive 88/490/EEC (3), contains a list of dangerous sub-
stances, together with particulars on the classification and
labelling procedures in respect of each substance;
Whereas Council Directive 88/379/EEC of 7 June 1988 on
the approximation of the laws, regulations and administra-tive provisions relating to the classification, packaging and
labelling of dangerous preparations (
4), as last amended by
Directive 89/178/EEC (5), contains particulars on the
classification and labelling procedures in respect of such
preparations;
Whereas the plan of action 1987 to 1989 adopted under
the ‘Europe against cancer’ programme provides for sup-
port for European studies on the possible cancer risks of
certain chemical substances;
Whereas, although current scientific knowledge is not such
that a level can be established below which risks to health
cease to exist, a reduction in exposure to carcinogens will
nonetheless reduce those risks;
Whereas nevertheless, in order to contribute to a reduction
in these risks, limit values and other directly related provi-
sions should be established for all those carcinogens for
which the available information, including scientific and
technical data, make this possible;
Whereas preventive measures must be taken for the
protection of the health and safety of workers exposed to
carcinogens;
Whereas this Directive lays down particular requirements
specific to exposure to carcinogens;
Whereas this Directive constitutes a practical aspect of the
realization of the social dimension of the internal market;
(1) OJ No L 183, 29. 6. 1989, p. 1.
(2) OJ No 196, 16. 8. 1967, p. 1.
(3) OJ No L 259, 19. 9. 1988, p. 1.
(4) OJ No L 187, 16. 7. 1988, p. 14.
(5) OJ No L 64, 8. 3. 1989, p. 18.
90/394/EEC - - - I
IIIWhereas, pursuant to Decision 74/325/EEC (1), as last
amended by the 1985 Act of Accession, the Advisory Com-
mittee on Safety, Hygiene and Health Protection at Work
is to be consulted by the Commission with a view to draw-
ing up proposals in this field,
HAS ADOPTED THIS DIRECTIVE:
(1) OJ No L 185, 9. 7. 1974, p. 15.
90/394/EEC - - - I
1SECTION I
GENERAL PROVISIONS
Article 1
Objective
1. This Directive, which is the sixth individual Directive
within the meaning of Article 16 (1) of Directive
89/391/EEC, has as its aim the protection of workers
against risks to their health and safety, including the pre-
vention of such risks, arising or likely to arise from expo-
sure to carcinogens at work.
It lays down particular minimum requirements in this area,
including limit values.
2. This Directive shall not apply to workers exposed only
to radiation covered by the T reaty establishing the Euro-
pean Atomic Energy Community.
3. Directive 89/391/EEC shall apply fully to the whole
area referred to in paragraph 1, without prejudice to more
stringent and/or specific provisions contained in this Direc-
tive.
4. As regards asbestos and vinyl chloride monomer,which are dealt with by specific Directives, the provisions
of this Directive shall apply when they are more favour-
able to safety and health at work.
Article 2
For the purposes of this Directive,
(a) “carcinogen” means:
(i) a substance which meets the criteria for classi-
fication as a category 1 or 2 carcinogen set out
in Annex VI of Directive 67/548/EEC;
(ii) a preparation composed of one or more sub-
stances referred to in point (i) where the con-
centration of one or more of the individual sub-
stances meets the requirements for concentration
limits for the classification of a preparation as a
category 1 or 2 carcinogen set out either:
— in Annex I to Directive 67/548/EEC, or
— in Annex I to Directive 88/379/EEC where
the substance or substances do not appear
in Annex I to Directive 67/548/EEC or ap-
pear in it without concentration limits;
(iii) a substance, preparation or process referred to in
Annex I as well as a substance or preparation
released by a process referred to in Annex I;90/394/EEC
97/42/EC
90/394/EEC - - - I
2(b) “limit value” means, unless otherwise specified, the
limit of the time-weighted average of the concentra-
tion for a “carcinogen” in the air within the breathing
zone of a worker in relation to a specified reference
period as set out in Annex III.
Article 3
Scope — determination and assessment of risks
1. This Directive shall apply to activities in which
workers are or are likely to be exposed to carcinogens as a
result of their work.
2. In the case of any activity likely to involve a risk of
exposure to carcinogens, 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.
The assessment must be renewed regularly and in any
event when any change occurs in the conditions which may
affect workers’ exposure to carcinogens.
The employer must supply the authorities responsible at
their request with the information used for making the
assessment.
3. Furthermore, when assessing the risk, account shall betaken of all other routes of exposure, such as absorption
into and/or through the skin
4. When the assessment referred to in paragraph 2 iscarried out, employers shall give particular attention to any
effects concerning the health or safety of workers at par-
ticular risk and shall, inter alia , take account of the desir-
ability of not employing such workers in areas where they
may come into contact with carcinogens.
SECTION II
EMPLOYERS’ OBLIGATIONS
Article 4
Reduction and replacement
1. The employer shall reduce the use of a carcinogen at
the place of work, in particular by replacing it, in so far as
is technically possible, by a substance, preparation or pro-
cess which, under its conditions of use, is not dangerous or
is less dangerous to workers’ health or safety, as the case
may be.
2. The employer shall, upon request, submit the findings
of his investigations to the relevant authorities.97/42/EC
90/394/EEC
97/42/EC
90/394/EEC
90/394/EEC - - - I
3Article 5
Prevention and reduction of exposure
1. Where the results of the assessment referred to in Ar-
ticle 3 (2) reveal a risk to workers’ health or safety,
workers’ exposure must be prevented.
2. Where it is not technically possible to replace the
carcinogen by a substance, preparation or process which,
under its conditions of use, is not dangerous or is less dan-
gerous to health or safety, the employer shall ensure that
the carcinogen is, in so far as is technically possible, manu-
factured and used in a closed system.
3. Where a closed system is not technically possible, the
employer shall ensure that the level of exposure of workers
is reduced to as low a level as is technically possible.
4. Exposure shall not exceed the limit value of a carci-nogen as set out in Annex III.
5. Wherever a carcinogen is used, the employer shall
apply all the following measures:
(a) limitation of the quantities of a carcinogen at the
place of work;
(b) keeping as low as possible the number of workers ex-
posed or likely to be exposed;
(c) design of work processes and engineering control
measures so as to avoid or minimize the release of
carcinogens into the place of work;
(d) evacuation of carcinogens at source, local extraction
system or general ventilation, all such methods to be
appropriate and compatible with the need to protect
public health and the environment;
(e) use of existing appropriate procedures for the
measurement of carcinogens, in particular for the
early detection of abnormal exposures resulting from
an unforeseeable event or an accident;
(f) application of suitable working procedures and
methods;
(g) collective protection measures and/or, where exposure
cannot be avoided by other means, individual protec-
tion measures;
(h) hygiene measures, in particular regular cleaning of
floors, walls and other surfaces;
(i) information for workers;90/394/EEC
97/42/EC
90/394/EEC - - - 97/42/EC
90/394/EEC - - - I
4(j) demarcation of risk areas and use of adequate warn-
ing and safety signs including ‘no smoking’ signs in
areas where workers are exposed or likely to be ex-
posed to carcinogens;
(k) drawing up plans to deal with emergencies likely to
result in abnormally high exposure;
(l) means for safe storage, handling and transportation,
in particular by using sealed and clearly and visibly
labelled containers;
(m) means for safe collection, storage and disposal of
waste by workers, including the use of sealed and
clearly and visibly labelled containers.
Article 6
Information for the competent authority
Where the results of the assessment referred to in Article
3 (2) reveal a risk to workers’ health or safety, employers
shall, when requested, make available to the competent
authority appropriate information on:
(a) the activities and/or industrial processes carried out,
including the reasons for which carcinogens are used;
(b) the quantities of substances or preparations manufac-
tured or used which contain carcinogens;
(c) the number of workers exposed;
(d) the preventive measures taken;
(e) the type of protective equipment used;
(f) the nature and degree of exposure;
(g) the cases of replacement.
Article 7
Unforeseen exposure
1. In the event of an unforeseeable event or an accident
which is likely to result in an abnormal exposure of
workers, the employer shall inform the workers thereof.
2. Until the situation has been restored to normal and
the causes of the abnormal exposure have been eliminated:
(a) only those workers who are essential to the carrying
out of repairs and other necessary work shall be per-
mitted to work in the affected area;90/394/EEC
90/394/EEC - - - I
5(b) the workers concerned shall be provided with protec-
tive clothing and individual respiratory protection
equipment which they must wear; the exposure may
not be permanent and shall be kept to the strict mini-
mum of time necessary for each worker;
(c) unprotected workers shall not be allowed to work in
the affected area.
Article 8
Foreseeable exposure
1. For certain activities such as maintenance, in respect
of which it is foreseeable that there is the potential for a
significant increase in exposure of workers, and in respect
of which all scope for further technical preventive
measures for limiting workers’ exposure has already been
exhausted, the employer shall determine, after consultation
of the workers and/or their representatives in the under-
taking or establishment, without prejudice to the
employer’s responsibility, the measures necessary to reduce
the duration of workers’ exposure to the minimum possible
and to ensure protection of workers while they are en-
gaged in such activities.
Pursuant to the first subparagraph, the workers concerned
shall be provided with protective clothing and individual
respiratory protection equipment which they must wear as
long as the abnormal exposure persists; that exposure may
not be permanent and shall be kept to the strict minimum
of time necessary for each worker.
2. Appropriate measures shall be taken to ensure that
the areas in which the activities referred to in the first sub-
paragraph of paragraph 1 take place are clearly demar-
cated and indicated or that unauthorized persons are pre-
vented by other means from having access to such areas.
Article 9
Access to risk areas
Appropriate measures shall be taken by employers to en-
sure that access to areas in which the activities in respect
of which the results of the assessment referred to in Ar-
ticle 3 (2) reveal a risk to workers’ safety or health take
place are accessible solely to workers who, by reason of
their work or duties, are required to enter them.
Article 10
Hygiene and individual protection
1. Employers shall be obliged, in the case of all activities
for which there is a risk of contamination by carcinogens,
to take appropriate measures to ensure that:90/394/EEC
90/394/EEC - - - I
6(a) workers do not eat, drink or smoke in working areas
where there is a risk of contamination by carcinogens;
(b) workers are provided with appropriate protective
clothing or other appropriate special clothing;
separate storage places are provided for working or
protective clothing and for street clothes;
(c) workers are provided with appropriate and adequate
washing and toilet facilities;
(d) protective equipment is properly stored in a well-de-
fined place;
it is checked and cleaned if possible before, and in
any case after, each use;
defective equipment is repaired or replaced before
further use.
2. Workers may not be charged for the cost of these
measures.
Article 11
Information and training of workers
1. Appropriate measures shall be taken by the employer
to ensure that workers and/or workers’ representatives in
the undertaking or establishment receive sufficient and ap-
propriate training, on the basis of all available information,in particular in the form of information and instructions,
concerning:
(a) potential risks to health, including the additional risks
due to tobacco consumption;
(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, including rescue
workers, in the case of incidents and to prevent inci-
dents.
The training shall be:
— adapted to take account of new or changed risk, and
— repeated periodically if necessary.
2. Employers shall inform workers of installations and
related containers containing carcinogens, ensure that all
containers, packages and installations containing carci-
nogens are labelled clearly and legibly, and display clearly
visible warning and hazard signs.90/394/EEC
90/394/EEC - - - I
7Article 12
Information for workers
Appropriate measures shall be taken to ensure that:
(a) workers and/or any workers’ representatives in the un-
dertaking or establishment can check that this Direc-
tive is applied or can be involved in its application, in
particular with regard to:
(i) the consequences for workers’ safety and health
of the selection, wearing and use of protective
clothing and equipment, without prejudice to the
employer’s responsibility for determining the ef-
fectiveness of protective clothing and equipment;
(ii) the measures determined by the employer which
are referred to in the first subparagraph of Ar-
ticle 8 (1), without prejudice to the employer’s
responsibility for determining such measures;
(b) workers and/or any workers’ representatives in the un-
dertaking or establishment are informed as quickly as
possible of abnormal exposures, including those re-
ferred to in Article 8, of the causes thereof and of the
measures taken or to be taken to rectify the situation;
(c) the employer keeps an up-to-date list of the workers
engaged in the activities in respect of which the re-
sults of the assessment referred to in Article 3 (2)
reveal a risk to workers’ health or safety, indicating, if
the information is available, the exposure to which
they have been subjected;
(d) the doctor and/or the competent authority as well as
all other persons who have responsibility for health
and safety at work have access to the list referred to
in subparagraph (c);
(e) each worker has access to the information on the list
which relates to him personally;
(f) workers and/or any workers’ representatives in the un-
dertaking or establishment have access to anonymous
collective information.
Article 13
Consultation and participation of workers
Consultation and participation of workers and/or their
representatives in connection with matters covered by this
Directive, including the Annexes hereto, shall take place in
accordance with Article 11 of Directive 89/391/EEC.90/394/EEC
90/394/EEC - - - I
8SECTION III
MISCELLANEOUS PROVISIONS
Article 14
Health surveillance
1. The Member States shall establish, in accordance with
national laws and/or practice, arrangements for carrying
out relevant health surveillance of workers for whom the
results of the assessment referred to in Article 3 (2) 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 ap-propriate, relevant health surveillance:
— prior to exposure,
— at regular intervals thereafter.
Those arrangements shall be such that it is directly poss-
ible to implement individual and occupational hygiene
measures.
3. If a worker is found to be suffering from an abnor-
mality which is suspected to be the result of exposure to
carcinogens, the doctor or authority responsible for the
health surveillance of workers may require other workers
who have been similarly exposed to undergo health surveil-
lance.
In that event, a reassessment of the risk of exposure shall
be carried out in accordance with Article 3 (2).
4. In cases where health surveillance is carried out, an
individual medical record shall be kept and the doctor or
authority responsible for health surveillance shall propose
any protective or preventive measures to be taken in re-
spect of any individual workers.
5. Information and advice must be given to workers re-
garding any health surveillance which they may undergo
following the end of exposure.
6. In accordance with national laws and/or practice:
— workers shall have access to the results of the health
surveillance which concern them, and
— the workers concerned or the employer may request a
review of the results of the health surveillance.
7. Practical recommendations for the health surveillance
of workers are given in Annex II.
8. All cases of cancer identified in accordance with
national laws and/or practice as resulting from occupationalexposure to a carcinogen shall be notified to the compet-
ent authority.90/394/EEC
90/394/EEC - - - I
9Article 15
Record-keeping
1. The list referred to in Article 12 (c) and the medical
record referred to in Article 14 (4) shall be kept for at
least 40 years following the end of exposure, in accordance
with national laws and/or practice.
2 . T h o s ed o c u m e n t ss h a l lb em a d ea v a i l a b l et ot h er e -
sponsible authority in cases where the undertaking ceases
activity, in accordance with national laws and/or practice.
Article 16
Limit values
1. The Council shall, in accordance with the procedure
laid down in Article 118a of the T reaty, set out limit values
in Directives on the basis of the available information, in-
cluding scientific and technical data, in respect of all those
carcinogens for which this is possible, and, where necess-
ary, other directly related provisions.
2. Limit values and other directly related provisions shall
be set out in Annex III.
Article 17
Annexes
1. Annexes I and III may be amended in accordance
only with the procedure laid down in Article 118a of the
Tr e a t y .
2. Purely technical adjustments to Annex II in the light
of technical progress, changes in international regulations
or specifications and new findings in the field of carci-
nogens shall be adopted in accordance with the procedure
laid down in Article 17 of Directive 89/391/EEC.
Article 18
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 (8).90/394/EEC
90/394/EEC - - - I
10Article 19
Final provisions
1. Member States shall bring into force the laws, regula-
tions and administrative provisions necessary to comply
with this Directive not later than 31 December 1992.
Should Directives 67/548/EEC or 88/379/EEC be amended
by amending Directives after notification of this Directive
with respect to the substances and preparations referred to
in Article 2 (a) and (b), Member States shall bring into
force the laws, regulations and administrative provisions
necessary to introduce the amendments in question into
the provisions referred to in the first subparagraph by the
deadlines laid down for implementation of such amending
Directives.
Member States shall forthwith inform the Commission that
the provisions referred to in this paragraph have been
brought into force.
2. Member States shall communicate to the Commission
the provisions of national law already adopted or which
they adopt in the future in the field governed by this Di-
rective.
Article 20
This Directive is addressed to the Member States.90/394/EEC
90/394/EEC - - - I
11ANNEX I
List of substances, preparations and processes
(Article 2 (c))
1. Manufacture of auramine.
2. Work involving exposure to polycyclic aromatic hydrocar-
bons present in coal soot, coal tar or coal pitch.
3. Work involving exposure to dusts, fumes and sprays pro-
duced during the roasting and electro-refining of cupro-
nickel mattes.
4. Strong acid process in the manufacture of isopropyl alcohol.90/394/EEC
97/42/EC
90/394/EEC
90/394/EEC - - - I
12ANNEX II
Practical recommendations for the health surveillance of workers
(Article 14 (7))
1. The doctor and/or authority responsible for the health
monitoring of workers exposed to carcinogens must be fam-
iliar with the exposure conditions or circumstances of each
worker.
2. Health monitoring of workers must be carried out in ac-
cordance with the principles and practices of occupational
medicine; it must include at least the following measures:
— keeping records of a worker’s medical and occupa-
tional history,
— a personal interview,— where appropriate, biological monitoring, as well as
detection of early and reversible effects.
Further tests may be decided upon for each worker when he
is the subject of health monitoring, in the light of the most
recent knowledge available to occupational medicine.90/394/EEC
90/394/EEC - - - I
13ANNEX III
Limit values and other directly related provisions
(Article 16)
A. LIMIT VALUES FOR OCCUPATIONAL EXPOSURE
Name ofEinecs(1) CAS(2)Limit values
Notation TransitionalmeasuresNameof
agentEinecs(1) CAS(2)
mg/m3(3) ppm (4)Notation Transitional measures
Benzene 200- - -753- - -7 7 1 --- 4 3 --- 2 3,25 (5)1(5) Skin Limit value: 3 ppm (= 9,75
mg/m3)u n t i l( 3y e a r sa f t e r
date in Article 2 (1) of Di-
rective 97/42/EC (*))
(1) EINECS: European Inventory of Existing Chemical Substances.
(2) CAS: Chemical Abstract Service Number.
(3)m g / m3= milligrams per cubic metre of air at 20 °C and 101,3 KPa (760 mm mercury pressure).
(4) ppm = parts per million by volume in air (ml/m3).
(5) Measured or calculated in relation to a reference period of eight hours.
(6) Substantial contribution to the total body burden via dermal exposure possible.
(*) OJ No L 179, 8. 7. 1997, p. 4.
B. OTHER DIRECTL Y RELATED PRIVISIONS (SIC! PROVISIONS)
p.m.90/394/EEC
97/42/EC
90/394/EEC