CELEX: 51987PC0641
Language: en
Date: 1987-12-10
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON THE PROTECTION OF WORKERS FROM THE RISKS RELATED TO EXPOSURE TO CARCINOGENS AT WORK ( SIXTH INDIVIDUAL DIRECTIVE WITHIN THE MEANING OF ARTICLE 8 OF DIRECTIVE 80/1107/EEC )

8. 2. 88                                   Official Journal of the European Communities                                  No C 34/9
                  Proposal for a Council Directive on the protection of workers from the risks related to exposure to
                  carcinogens at work (sixth individual Directive within the meaning of Article 8 of Directive
                                                             80/1107/EEC)
                                                           COM(87) 641 final
                                  (Submitted by the Commission to the Council on 21 December 1987)
                                                              (88/C 34/03)
 THE COUNCIL OF THE EUROPEAN COMMUNITIES,                               Whereas the proposal for a plan of action 1987 to 1989
                                                                        contained in the 'Europe against cancer' programme( 5 )
 Having regard to the Treaty establishing the European                  provides for Directives for the protection of workers against
 Economic Community, and in particular Article 118A                     carcinogenic substances;
 thereof,
                                                                        Whereas, although current scientific knowledge is not such
 Having regard to the proposal from the Commission, drafted             that a level can be established below which risks to health
 following consultation with the Advisory Committee on                  cease to exist, a reduction in exposure to carcinogens will
 Safety, Hygiene and Health Protection at Work,                         nonetheless reduce these risks;
 In cooperation with the European Parliament,                           Whereas employers must keep abreast of new developments
                                                                        in technology with a view to improving the protection of
                                                                        workers' health and safety;
 Having regard to the opinion of the Economic and Social
 Committee,
                                                                        Whereas preventive measures should be taken for the
                                                                        protection of the health and safety of workers exposed to
Whereas, pursuant to Article 118A of the Treaty, the                    carcinogens;
 Council shall adopt, by means of Directives, minimum
 requirements in order to encourage improvements, especially
                                                                        Whereas it is necessary, in order to ensure the highest degree
 in the working environment, as regards the health and safety
                                                                        of protection reasonably practicable, that workers and their
of workers;
                                                                        representatives be informed about the risks which
                                                                        carcinogens can pose for their health and about the measures
Whereas the Council resolution of 27 February 1984 on a                 necessary to lessen or eliminate those risks and that they
 second action programme of the European Communities on                 should be in a position to ensure that the necessary protective
safety and health at work (*) provides for the development of           measures are taken,
protective measures for workers exposed to carcinogens;
Whereas Council Directive 80/1107/EEC of 27 November
 1980 on the protection of workers from the risks related to            HAS ADOPTED THIS DIRECTIVE:
exposure to chemical, physical and biological agents at
work( 2 ) laid down such principles which have to be taken
into account for such protection;                                                                  OBJECTIVE
Whereas, under the terms of the said Directive, such                                                 Article 1
protection should as far as possible be ensured by measures to
prevent exposure or to keep it at as low a level as is                  1.     This Directive, which is the sixth individual Directive
reasonably practicable;                                                within the meaning of Article 8 of Directive 80/1107/EEC,
                                                                       has as its aim the protection of workers against risks to their
Whereas Council Directive 67/548 /EEC of 27 June 1967 on               health and safety, including the prevention of such risks,
the approximation of laws, regulations and administrative              arising or likely to arise from exposure to carcinogens at
provisions relating to the classification, packaging and               work.
labelling of dangerous substances(3) contains a list of
dangerous substances, together with particulars of the                  2.     This Directive shall not apply to workers:
classification and labelling procedures in respect of each
substance; whereas this list has been adapted in the light of          — engaged in sea transport and in air transport. For the
scientific and technical knowledge, most recently by                        purpose of this Directive 'workers engaged in sea
Directive 87/432/EEC( 4 );                                                  transport and in air transport' means personnel on
                                                                            board,
(»)  O J N o C 6 7 , 8. 3. 1984, p. 2.
(2)  OJ No L 327, 3. 12. 1980, p. 8.                                   — exposed only to ionizing radiations.
(3)  OJNo 196, 16. 8. 1967, p. 1.
(4)  OJ No L 239, 21. 8. 1987, p. 1.                                   (5) O J N o C 5 0 , 26. 2. 1987, p. 1.
 ---pagebreak--- No C 34/10                                 Official Journal of the European Communities                                      8. 2. 88
                          DEFINITION                                  (e) application     of  suitable   working    procedures    and
                                                                           methods;
                            Article 2                                 (f) collective protection measures;
For the purposes of this Directive, a carcinogen is:                  (g) individual protection measures, where exposure cannot
                                                                           reasonably be avoided by other means;
— a chemical agent as designated in Annex I by its number in
    the Chemical Abstracts Service register,                          (h) hygiene measures;
                                                                      (i) information for workers;
— an industrial process as designated in Annex II.
                                                                      (j) use of warning and safety signs including 'no smoking'
                                                                           signs in areas where workers are exposed or likely to be
                                                                           exposed to carcinogens;
                         ASSESSMENT
                                                                      (k) surveillance of the health of workers;
                            Article 3                                 (1) keeping of updated lists of workers exposed or likely to
                                                                           be exposed and of health surveillance records;
1.     This Directive shall apply to activities in which
                                                                      (m) emergency measures for abnormal exposures;
workers are or are likely to be exposed to carcinogens as a
result of their work.                                                 (n) means for adequate safe storage, handling and
                                                                           transportation, in particular by using sealed and properly
2.     In the case of any activity or sector of activity likely to         labelled containers;
involve a risk of exposure to carcinogens the risk must be
assessed in such a way as to determine the nature and degree          (o) means for safe collection, storage and disposal of waste,
of the workers' exposure.                                                  including the use of sealed and properly labelled
                                                                           containers.
                 PREVENTION OF EXPOSURE                                 INFORMATION FOR THE COMPETENT AUTHORITIES
                            Article 4                                                             Article 5
1.     In the case of any activity or sector of activity likely to    For every activity referred to in Article 3(1), employers shall,
involve a risk of exposure to a carcinogen the exposure of            when so requested, make available to the competent
workers shall be prevented in so far as is reasonably                 authorities appropriate information on:
practicable by ensuring that the production and use of that
carcinogen take place in a closed system.                             — the activities and/or industrial processes carried out,
                                                                          including the reasons for which carcinogens are used,
2.     Employers shall make the necessary arrangements to             — the quantities of substances or                  preparations
identify any activity or sector of activity in which it is not            manufactured or used which contain carcinogenic
reasonably practicable to use a closed system. In all case the            agents,
exposure of workers must be reduced to as low a level as is
reasonably practicable, in particular through the use of some         — the number of workers exposed,
or all of the following measures as appropriate:
                                                                      — the preventive measures taken,
(a) limitation of the use of a carcinogen at the place of work,
    in particular by its replacement by another agent or              — the type of protective equipment used.
    process which is less dangerous to workers' health;
(b) limitation of the number of workers exposed or likely to
    be exposed;                                                                          ABNORMAL EXPOSURES
(c) design of work processes and engineering control                                              Article 6
    measures so as to avoid or to minimize the release of
    carcinogens into the place of work;                               In the event of an unforeseeable event or an accident which is
                                                                      likely to result in an abnormal exposure of workers:
(d) use of adequate measurement procedures for
    carcinogenic agents, in particular for the early detection        (a) only those workers who are required to take remedial
    of abnormal exposures due to an unforeseeable event or                  action and carry out other necessary work shall be
    an accident;                                                            permitted to work in the affected zone;
 ---pagebreak--- 8. 2. 88                                  Official Journal of the European Communities                                No C 34/11
(b) the workers concerned shall be provided with protective          (d) protective equipment is properly stored in a well-defined
      clothing and individual respiratory protection                      place and is checked and cleaned if possible before, and
      equipment which they must wear as long as the                       in any case after, each use; defective equipment shall be
      abnormal exposure persists; that exposure may not be                repaired or replaced before further use.
      permanent and shall be kept to the strict minimum of
      time necessary for each worker;
                                                                     2.     Workers may not be charged for the cost of these
(c) unprotected workers shall not be allowed to work in the          measures.
      affected areas until the situation has been restored to
      normal, and the causes for the increase eliminated.
                                                                                    INFORMATION AND TRAINING
                            Article 7
                                                                                                Article 10
For certain activities such as maintenance, in respect of which
it is foreseeable that there will be a significant increase in       1.     Appropriate measures shall be taken by the employer
exposure of workers, and in respect of which further                 to ensure that workers and /or any workers' representatives
technical preventive measures for limiting workers' exposure         in the undertaking or establishment receive adequate
are not reasonably practicable, the employer shall determine         information, regular training and instructions concerning:
the collective measures intended to reduce the duration of
workers' exposure to the minimum possible and to ensure              (a) potential risks to health;
adequate protection of workers while they are engaged in
such activities.                                                     (b) the precautions to be taken to prevent exposure;
In particular, Article 6 (b) shall apply.                            (c) hygiene requirements;
                                                                     (d) wearing and        use  of    protective  equipment   and
                                                                          clothing;
                       ACCESS TO AREAS                               (e) steps to be taken by workers, including rescue workers,
                                                                          in the case of incidents and to prevent incidents.
                            Article 8
                                                                     2.     Employers shall ensure that workers are adequately
Appropriate measures shall be taken to ensure that access to         informed of installations and related containers containing
the places in which the activities referred to in Article 3(1)       carcinogens and that, where appropriate, such information
take place is restricted solely to workers who, by reason of         takes the form of suitable warning and hazard signs.
their work or duties, are required to enter them.
                                                                                                Article 11
         PROTECTIVE CLOTHING AND EQUIPMENT
                             Article 9                               Appropriate measures shall be taken to ensure that:
                                                                     (a) workers and/or any workers' representatives in the
1.      Appropriate measures shall be taken, where this is               undertaking or establishment can check that this
reasonably practicable, to ensure that:                                  Directive is applied or be involved in its application, in
                                                                         particular with the selection, wearing and use of
(a) workers do not eat, drink or smoke in working areas                  protective clothing and equipment;
      where there is a risk of contamination by
      carcinogens;                                                   (b) workers and/or workers' representatives in the
                                                                         undertaking or establishment are informed as quickly as
(b)    (i) workers are provided with appropriate protective              possible of abnormal exposure, of the causes thereof and
            clothing or other appropriate special clothing,              of the measures taken or to be taken to rectify the
      (ii) separate storage places are provided for working or           situation;
            protective clothing and for street clothes;
                                                                     (c) the employer keeps a list of the workers engaged in the
(c) workers are provided with appropriate and adequate                   activities referred to in Article 3 (1), indicating where
      washing and toilet facilities; including showers in the            appropriate the exposure to which they may have been
      case of dusty operations;                                          subjected;
 ---pagebreak--- No C 34/12                               Official Journal of the European Communities                                      8. 2. 88
(d) the doctor and/or the competent authority as well as all        6.    The workers concerned or the employer may request a
     other persons who have responsibility for health and           review of the assessment referred to in this Article, in
     safety at work have access to the list referred to at (c);     accordance with national laws and practice.
(e) each worker has access to the information in the list           7.    Practical recommendations for the health surveillance
     which relates to him personally;                               of workers is given in Annex III. Those recommendations
                                                                    may be adapted in the light of technical progress as provided
(f) workers and/or any workers' representatives in the              for in Article 10 of Directive 80/1107/EEC.
     undertaking or establishment have access to anonymous,
     collective information;
(g) workers and/or any workers' representatives in the
                                                                                         RECORD KEEPING
     undertaking or establishment can receive information on
     the potential risks to health from exposure to
     carcinogens.                                                                             Article 13
                                                                    The following measures shall be taken:
                                                                    1. The list referred to in Article 11 (c) and the health record
                  HEALTH SURVEILLANCE                                   referred to in Article 12 (4) shall be kept for at least 30
                                                                        years following the end of exposure, in accordance with
                          Article 12                                    national laws and practice.
                                                                    2. Those records shall be made available to the competent
1.     Special arrangements for carrying out the relevant               authority in cases where the undertaking ceases its
health surveillance of workers exposed to carcinogens shall             activity, in accordance with national laws and
be established by the Member States in accordance with                  practice.
national laws and practice.                         >
2.     The arrangements referred to in paragraph 1 shall be
such that each worker exposed to carcinogens shall be able to                          NATIONAL STATISTICS
undergo an assessment of his state of health:
                                                                                              Article 14
— prior to exposure,
                                                                    Member States shall keep national statistics of recognized
— at regular intervals thereafter.
                                                                    cases of occupational diseases due to carcinogens.
This assessment shall be such that it is directly possible to
implement hygiene and individual measures.
                                                                                         FINAL PROVISIONS
3.     If a worker is found to be suffering from an
abnormality which is suspected to be the result of exposure to                                Article 15
carcinogens, the doctor or the authority competent for the
health surveillance of workers may require other workers            1.    Member States shall adopt the laws, regulations and
who have been similarly exposed to undergo health                   administrative provisions necessary to comply with this
surveillance, and a reassessment of the risk of exposure shall      Directive by 31 December 1989. They shall immediately
be carried out in accordance with Article 3 (2).                    inform the Commission thereof.
4.     In cases where health surveillance is carried out, an        2.    Member States shall communicate to the Commission
individual health record shall be kept and the doctor or the        the provisions of national law which they adopt in the field
authority competent for health surveillance shall propose any       governed by this Directive.
protective or preventive measures to be taken in respect of
any individual worker.
5.     Information and advice must be given to workers                                        Article 16
regarding any health surveillance which they may undergo
following the end of exposure.                                      This Directive is addressed to the Member States.
 ---pagebreak--- 8. 2. 88                                  Official Journal of the European Communities                                No C 34/13
                                                                 ANNEX I
                                                 LIST OF CARCINOGENIC AGENTS
                                      (to which reference is made in Articles 2 and 3 (3) and (4))
                     CAS (>) No             EEC No                            Name of agent              Formula
                       of agent             of agent
              1     00107-13-1           608-003-00-4        Acrylonitrile                         C3H3N
              2     01327-53-3           033-003-00-0        Arsenic trioxide                      As 2 0 3
              3     00542-88-1           603-046-00-5        Bis (chloromethyl) ether              C 2 H 4 C1 2 0
              4     10108-64-2           048-008-00-3        Cadmium chloride                      CdCl 2
              5     13765-19-0           024-008-00-9        Calcium chromate                      CaCr0 4
              6     00107-30-2           603-075-00-3        Chloromethyl methyl ether             C 2 H 5 C10
              7     00096-12-8           602-021-00-6        1,2-dibromo-3-chloropropane           C 3 H s Br 2 Cl
              8     00091-94-1           612-068-00-4        3,3' -dichlorobenzidine               C 12 H 10 C1 2 N 2
              9           —              612-069-00-X        Salts of 3,3' -dichlorobenzidine      C 12 H 10 C1 2 N 2
             10     00064-67-5           016-027-00-6        Diethyl sulphate                      v^rllOW^
             11     00079-44-7           006-041-00-0        Dimethylcarbamoyl chloride            C 3 H 6 ClNO
             12     00057-14-7           007-012-00-5        N ,N-dimethylhydrazine                C2H8N2
             13     00077-78-1           016-023-00-4        Dimethyl sulphate                     C2H604S
         '   14     00106-89-8           603-026-00-6        Epichlorohydrin                       C 3 H S C10
             15     00106-93-4           602-010-00-6        Ethylene dibromide                    C 2 H 4 Br 2
             16     00075-21-8           603-023-00-X        Ethylene oxide                        C2H40
             17     00680-31-9           015-106-00-2        Hexamethylphosphoric triamide         C 6 H 1 8 N 3 OP
             18     00101-14-4           612-078-00-9        4,4' -methylene bis (2-chloroaniline) C 13 H 12 C1 2 N 2
             19     00602-87-9           609-037-00-2        5-nitroacenaphthene                   C12H9N02
            20     00581-89-5            609-038-00-8        2-nitronaphthalene                    C 1 0 H 7 NO 2
            21      00079-46-9           609-002-00-1        2-nitropropane                        C3H7N02
            22     00062-75-9            612-077-00-3        N-nitrosodimethylamine                C2H6N20
            23     00119-90-4            612-036-00-X        o-dianisidine                         C14H)6N202
            24            —              612-037-00-5        Salt of O-dianisidine                 C14H16N202 .
            25     01120-71-4            016-032-00-3        1,3-propanesultone                    C3H603S
            26     00057-57-8            606-031-00-1        Propanolide                           C3H402
            27     00075-55-8            613-033-00-6        Propyleneimine                        C3H7N
            28     07789-06-2            024-009-00-4        Strontium chromate                    Cr0 4 Sr
            29     00119-93-7            612-041-00-7        O-tolidine                            C14H16N2
            30            —              612-081-00-5        Salt of O-tolidine                    C 14 H 16 N 2
            31      13550-65-9           024-007-00-3        Zinc chromate                         Cr0 4 Zn
         (') Number in the register of the Chemical Abstract Service (CAS).
 ---pagebreak--- No C 34/14                                   Official Journal of the European Communities                                           8. 2. 88
                                                                 ANNEX II
INDUSTRIAL PROCESSES                                                       AGENTS PROBABLY CONCERNED
1. Auramine manufacture                                                    Auramine
2. Boot and shoe manufacture (certain occupations)                         Leather dust
3. Coal gasification (older processes)                                     Coal tar and coal tar fumes
                                                                           Certain hydrocarbons polynuclear aromatic
4. Coke production                                                         Coal tar and coal tar fumes
                                                                           Certain hydrocarbons polynuclear aromatic
5. Furniture manufacture (wood dust)                                       Certain wood dusts
6. Isopropyl alcohol manufacture (strong acid process)                     Isopropyl alcohol
7. Nickel refining                                                         Nickel subsulphide
                                                                           Nickel oxides
8. Rubber industry (certain occupations, such as milling, extruding        Certain aromatic amines
   and vulcanization)                                                      Certain organic solvents
                                                                 ANNEX III
               PRACTICAL RECOMMENDATIONS FOR THE HEALTH SURVEILLANCE OF WORKERS, AS
                                                    REFERRED T O IN ARTICLE 12 (7)
               1. The doctor and / or authority competent for the health surveillance of workers exposed to carcinogens must be
                   familiar with the exposure conditions or circumstances of each worker.
               2. Health surveillance of workers should be carried out in accordance with the principles and practices of
                   occupational medicine; it should 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 should be decided upon for each worker when he is the subject of health surveillance, in the light
                   of the most recent knowledge available to occupational medicine.