1990L0394 — EN — 01.06.1999 — 002.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL DIRECTIVE
of 28June 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 L 196, 26.7.1990, p. 1)
Amended by:
Official Journal
No page date
►M1Council Directive 97/42/EC of 27 June 1997 L 179 4 8.7.1997
►M2Council Directive 1999/38/EC of 29 April 1999 L 138 66 1.6.1999
Corrected by:
►C1Corrigendum, OJ L 37, 12.2.2000, p. 35 (1999/38/EC)
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COUNCIL DIRECTIVE
of 28June 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 Treaty establishing the European Economic
Community, and in particular Article 118a thereof,
Having regard to the proposal from the Commission(1), drawn up
following consultation with the Advisory Committee 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 Treaty provides that the Council is to adopt,
by means of Directives, minimum requirements in order to encourageimprovements, especially in the working environment, so as toguarantee better protection of the health and safety of workers;
Whereas, according to that Article, such directives must avoid imposing
administrative, financial and legal constraint in a way which would holdback the creation and development of small and medium-sizedundertakings;
Whereas the Council resolution of 27 February 1984 on a second action
programme of the European Communities on safety and health atwork(
4) provides for the development of protective measures for
workers exposed to carcinogens;
Whereas the Commission communication on its programme 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 designed to
guarantee a better standard of health and safety as regards the protectionof workers from the risks related to exposure to carcinogens at work isessential to ensure the health and safety of workers;
Whereas 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 encourage improvements in the health andsafety of workers at work(
6); whereas therefore the provisions of that
Directive 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 administrative provisionsrelating to the classification, packaging and labelling of dangerous
substances(
7), as last amended by Directive 88/490/EEC(8), contains a
list of dangerous substances, together with particulars on the classifica-tion 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 administrative provisions1990L0394 — EN — 01.06.1999 — 002.001 — 2
(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.
(6) OJ No L 183, 29. 6. 1989, p. 1.
(7) OJ No 196, 16. 8. 1967, p. 1.
(8) OJ No L 259, 19. 9. 1988, p. 1.
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relating to the classification, packaging and labelling of dangerous
preparations(1), as last amended by Directive 89/178/EEC(2), 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 support 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 provisions should be establishedfor all those carcinogens for which the available information, includingscientific 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;
Whereas, pursuant to Decision 74/325/EEC(
3), as last amended by the
1985 Act of Accession, the Advisory Committee on Safety, Hygiene andHealth Protection at Work is to be consulted by the Commission with aview to drawing up proposals in this field,
HAS ADOPTED THIS DIRECTIVE:
SECTION 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 theprotection of workers against risks to their health and safety, includingthe prevention of such risks, arising or likely to arise from exposure to►
M2carcinogens or mutagens ◄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 Treaty establishing the European Atomic EnergyCommunity.
3. Directive 89/391/EEC shall apply fully to the whole area referred
to in paragraph 1, without prejudice to more stringent and/or specificprovisions contained in this Directive.
4. As regards asbestos, which is dealt with by Directive 83/477/
EEC(
4) the provisions of this Directive shall apply when they are more
favourable to health and safety at work.1990L0394 — EN — 01.06.1999 — 002.001 — 3
(1) OJ No L 187, 16. 7. 1988, p. 14.
(2) OJ No L 64, 8. 3. 1989, p. 18.
(3) OJ No L 185, 9. 7. 1974, p. 15.
(4) OJ L 263, 24.9.1983, p. 25. Directive as last amended by Directive 98/24/EC
(OJ L 131, 5.5.1998, p. 11).▼M2
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Article 2
For the purposes of this Directive,
(a) ‘carcinogen’ means:
(i) a substance which meets the criteria for classification as a
category 1 or 2 carcinogen set out in Annex VI of Directive67/548/EEC;
(ii) a preparation composed of one or more substances referred to
in point (i) where the concentration of one or more of theindividual substances 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 appear 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;
(aa) ‘mutagen’ means:
(i) a substance which meets the criteria for classification as a
category 1 or 2 mutagen set out in Annex VI to Directive 67/548/EEC;
(ii) a preparation composed of one or more substances referred to
in (i) where the concentration of one or more of the individual
substances meets the requirements for concentration limits forthe classification of a preparation as a category 1 or 2 mutagenset out in either:
— Annex I to Directive 67/548/EEC, or
— Annex I to Directive 88/379/EEC where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;
(b) ‘limit value’ means, unless otherwise specified, the limit of the
time-weighted average of the concentration for a‘►
M2carcinogen or mutagen ◄’ in the air within the breathing
zone of a worker in relation to a specified reference period as setout 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 ►
M2carcinogens or mutagens ◄as a result of
their work.
2. In the case of any activity likely to involve a risk of exposure to
►M2carcinogens or mutagens ◄, 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 themeasures 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►
M2carcinogens or mutagens ◄.
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 be taken of all
other routes of exposure, such as absorption into and/or through the skin1990L0394 — EN — 01.06.1999 — 002.001 — 4
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4. When the assessment referred to in paragraph 2 is carried out,
employers shall give particular attention to any effects concerning thehealth or safety of workers at particular risk and shall, inter alia , take
account of the desirability of not employing such workers in areas where
they may come into contact with ►
M2carcinogens or mutagens ◄.
SECTION II
EMPLOYERS' OBLIGATIONS
Article 4
Reduction and replacement
1. The employer shall reduce the use of a ►M2carcinogen or
mutagen ◄at the place of work, in particular by replacing it, in so far
as is technically possible, by a substance, preparation or process 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.
Article 5
Prevention and reduction of exposure
1. Where the results of the assessment referred to in Article 3 (2)
reveal a risk to workers' health or safety, workers' exposure must beprevented.
2. Where it is not technically possible to replace the
►
M2carcinogen or mutagen ◄by a substance, preparation or process
which, under its conditions of use, is not dangerous or is less dangerous
to health or safety, the employer shall ensure that the ►M2carcinogen
or mutagen ◄is, in so far as is technically possible, manufactured 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 alevel as is technically possible.
4. Exposure shall not exceed the limit value of a carcinogen as set out
in Annex III.
►
M15.◄Wherever a ►M2carcinogen or mutagen ◄is used,
the employer shall apply all the following measures:
(a) limitation of the quantities of a ►M2carcinogen or mutagen ◄at
the place of work;
(b) keeping as low as possible the number of workers exposed or likely
to be exposed;
(c) design of work processes and engineering control measures so as to
avoid or minimize the release of ►M2carcinogens or mutagens ◄
into the place of work;
(d) evacuation of ►M2carcinogens or mutagens ◄at source, local
extraction system or general ventilation, all such methods to beappropriate and compatible with the need to protect public health
and the environment;
(e) use of existing appropriate procedures for the measurement of
►
M2carcinogens or mutagens ◄, in particular for the early
detection of abnormal exposures resulting from an unforeseeableevent 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 protection measures;
(h) hygiene measures, in particular regular cleaning of floors, walls and
other surfaces;1990L0394 — EN — 01.06.1999 — 002.001 — 5
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(i) information for workers;
(j) demarcation of risk areas and use of adequate warning and safety
signs including ‘no smoking’ signs in areas where workers are
exposed or likely to be exposed to ►M2carcinogens or
mutagens ◄;
(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 ►M2carcinogens or mutagens ◄are used;
(b) the quantities of substances or preparations manufactured or used
which contain ►M2carcinogens or mutagens ◄;
(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 permitted to work in the affectedarea;
(b) the workers concerned shall be provided with protective clothing
and individual respiratory protection equipment which they must
wear; the exposure may not be permanent and shall be kept to the
strict minimum 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 inexposure of workers, and in respect of which all scope for furthertechnical preventive measures for limiting workers' exposure has alreadybeen exhausted, the employer shall determine, after consultation of the
workers and/or their representatives in the undertaking or establishment,
without prejudice to the employer's responsibility, the measuresnecessary to reduce the duration of workers' exposure to the minimumpossible and to ensure protection of workers while they are engaged insuch activities.1990L0394 — EN — 01.06.1999 — 002.001 — 6
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Pursuant to the first subparagraph, the workers concerned shall be
provided with protective clothing and individual respiratory protectionequipment 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 subparagraph of paragraph 1
take place are clearly demarcated and indicated or that unauthorized
persons are prevented by other means from having access to such areas.
Article 9
Access to risk areas
Appropriate measures shall be taken by employers to ensure that access
to areas in which the activities in respect of which the results of theassessment referred to in Article 3 (2) reveal a risk to workers' safety orhealth take place are accessible solely to workers who, by reason of theirwork 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 ►
M2carcinogens or mutagens ◄,
to take appropriate measures to ensure that:
(a) workers do not eat, drink or smoke in working areas where there is a
risk of contamination by ►M2carcinogens or mutagens ◄;
(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-defined 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 establish-
ment receive sufficient and appropriate training, on the basis of allavailable information, in particular in the form of information andinstructions, 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 incidents.
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 ►
M2carcinogens or mutagens ◄, ensure that1990L0394 — EN — 01.06.1999 — 002.001 — 7
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all containers, packages and installations containing ►M2carcinogens
or mutagens ◄are labelled clearly and legibly, and display clearly
visible warning and hazard signs.
Article 12
Information for workers
Appropriate measures shall be taken to ensure that:
(a) workers and/or any workers' representatives in the undertaking or
establishment can check that this Directive is applied or can beinvolved 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, withoutprejudice to the employer's responsibility for determining the
effectiveness of protective clothing and equipment;
(ii) the measures determined by the employer which are referred to
in the first subparagraph of Article 8 (1), without prejudice tothe employer's responsibility for determining such measures;
(b) workers and/or any workers' representatives in the undertaking or
establishment are informed as quickly as possible of abnormal
exposures, including those referred to in Article 8, of the causes
thereof and of the measures taken or to be taken to rectify thesituation;
(c) the employer keeps an up-to-date list of the workers engaged in the
activities in respect of which the results of the assessment referred toin 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 tothe 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 undertaking 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 theAnnexes hereto, shall take place in accordance with Article 11 of
Directive 89/391/EEC.
SECTION 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 healthsurveillance of workers for whom the results of the assessment referredto 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 appropriate, relevant healthsurveillance:
— prior to exposure,
— at regular intervals thereafter.
Those arrangements shall be such that it is directly possible to
implement individual and occupational hygiene measures.1990L0394 — EN — 01.06.1999 — 002.001 — 8
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3. If a worker is found to be suffering from an abnormality which is
suspected to be the result of exposure to ►M2carcinogens or
mutagens ◄, the doctor or authority responsible for the health
surveillance of workers may require other workers who have been
similarly exposed to undergo health surveillance.
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 forhealth surveillance shall propose any protective or preventive measuresto be taken in respect of any individual workers.
5. Information and advice must be given to workers regarding 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 occupational exposure to a►
M2►C1carcinogen or mutagen ◄◄shall be notified to the
competent authority.
Article 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. Those documents shall be made available to the responsible
authority in cases where the undertaking ceases activity, in accordancewith 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 Treaty, set out limit values in Directives on the basis
of the available information, including scientific and technical data, inrespect of all those ►
M2carcinogens or mutagens ◄for which this is
possible, and, where necessary, 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 Treaty.
2. Purely technical adjustments to Annex II in the light of technical
progress, changes in international regulations or specifications and newfindings in the field of ►
M2carcinogens or mutagens ◄shall be
adopted in accordance with the procedure laid down in Article 17 ofDirective 89/391/EEC.1990L0394 — EN — 01.06.1999 — 002.001 — 9
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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).
Article 19
Final provisions
1. Member States shall bring into force the laws, regulations 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 thesubstances and preparations referred to in Article 2 (a) and (b), MemberStates shall bring into force the laws, regulations and administrativeprovisions 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 thefuture in the field governed by this Directive.
Article 20
This Directive is addressed to the Member States.1990L0394 — EN — 01.06.1999 — 002.001 — 10
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ANNEX I
List of substances, preparations and processes
(Article 2 (c))
1. Manufacture of auramine.
2. Work involving exposure to polycyclic aromatic hydrocarbons present in coal
soot, coal tar or coal pitch.
3. Work involving exposure to dusts, fumes and sprays produced during the
roasting and electro-refining of cupro-nickel mattes.
4. Strong acid process in the manufacture of isopropyl alcohol.
5. Work involving exposure to hardwood dusts(1).1990L0394 — EN — 01.06.1999 — 002.001 — 11
(1) A list of some hardwoods is to be found in Volume 62 of the Monographs on the
Evaluation of Carcinogenic Risks to Humans ‘Wood Dust and Formaldehyde’, published
by the International Agency for Research on Cancer, Lyon 1995.▼M1
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ANNEX 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 ►M2►C1carcinogens or mutagens ◄◄must be familiar
with the exposure conditions or circumstances of each worker.
2. Health monitoring 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 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.1990L0394 — EN — 01.06.1999 — 002.001 — 12
ANNEX III
Limit values and other directly related provisions
(Article 16)
A. LIMIT VALUES FOR OCCUPATIONAL EXPOSURE
Name of agent EINECS (1) CAS (2)Limit values
Notation Transitional measures
mg/m3(3) ppm (4)
Benzene 200-753-7 71-43-2 3,25 (5)1 (5) Skin (6) Limit value:
3 ppm (= 9,75 mg/m3) until three years after date in Article 2(1) of
Directive 97/42/EC (*)
Vinyl chloride monomer 200-831 75-01-4 7,77 (5)3 (5)— —
Hardwood dusts — — 5,0 (5)(7)— — —
(1) EINECS: European Inventory of Existing Chemical Substances.
(2) CAS: Chemical Abstract Service Number.
(3) mg/m3= milligrams per cubic metre of air at 20 ºC 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.
(7) Inhalable fraction; if hardwood dusts are mixed with other wood dusts, the limit value shall apply to all wood dusts present in that mixture.
(*) OJ L 179, 8.7.1997, p. 4.
B. OTHER DIRECTLY RELATED PRIVISIONS (SIC! PROVISIONS)
p.m.▼B1990L0394 — EN — 01.06.1999 — 002.001 — 13▼M2
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