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) (submitted by the Commission)

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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                             COM(87) 641 final
                                              Brussels , 10 December 1987
                                    Proposai 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 )
                           ( submitted by the Commission )
                                          ΥΜ 18 η
   C0M(87 ) 641 final
                                           io 30
 ---pagebreak---                                                                    con-fy'i
                                       4
     PROPOSAL FOR A COUNCIL DIRECTIVE ON THE PROTECTION OF WORKERS
        FROM THE RISKS RELATED TO EXPOSURE TO CARCINOGENS AT WORK
EXPLANATORY MEMORANDUM
1.    Introduction
      The Communication of the Commission of the European Communities
      on its Programme concerning Safety , Hygiene and Health at Work
      ( 1 ) states that the Commission " intends to submit to the Council
      in late        19-87 a Directive laying down general and specific
      measures to deal with a list of occupational carcinogens ".
      Previously , pursuant to the Council Resolution of 27 February
      1984 on a Second Programme of Action of the European Communities
      on Safety and Health at Work ( 2 ), two proposals concerning
      carcinogens had been presented by the Commission to the Council .
      One was a proposal for the proscribing of specified agents and/or
      activities responsible for cancer of the bladder ( 3 ), and the
      other concerned benzene ( 4 ). These proposals represented a
      continuation of the strategy adopted in the past , which had led
      to the adoption by the Council of the two Directives on the
      protection of workers against vinyl chloride monomer ( 5 ) and
      asbestos ( 6 ) .
 (1)
 (2)  JO    No C 67 , 8.3.1984 , page 2
 (3)  JO    No C 270 , 10.10.1984 , page 3
 (4)  JO    No C 349 , 31.12.1985 , page 32
 (5)   JO   No L 197 , 22.7.1978 , page 12
 (6)   JO   No L 263 , 24.9.1983 , page 25
 ---pagebreak---                                  - 2 -
    A fresh impetus was provided by the Resolution of the Council and
    the representatives of the Governments of the Member States ,
    meeting within the Council , on a programme of action of the
    European Communities against cancer ( 7 ) and by the Proposal for a
    plan of action 1987-1989 , presented by the Commission to the
    Council as part of the " Europe against cancer " programme ( 8 ).
    In order to speed up progress towards the prevention of occup¬
    ational cancer it now seems appropriate to abandon the strategy
    of producing directives on individual agents and instead to use
    their contents in order to formulate a new approach directed
    towards the production of a general directive , with the aim of
    harmonizing the conditions existing in this field in the indi¬
    vidual Member States .
2.  Summary of legislation concerning occupational exposure to
    carcinogens in the individual Member States
    It has long been recognized in the industrialized countries that
    occupational cancer poses a serious risk to workers . The need to
    prevent and monitor this risk has led all Member States of the
    European Community to introduce legislation concerning either
    carcinogenic agents in general or specific carcinogenic agents .
    However , even when they are dealing with the same subject ,
    national regulations differ considerably from one another both in
    scope and in the importance which they attribute to the various
    aspects of the question .
    Most are based on the data obtained from cancer registers kept in
    certain countries and from epidemiological studies conducted in
    various parts of the world ; other basic sources are international
    organizations such as the International Labour Office and the
    World Health Organization , and in particular the International
    Agency for Research on Cancer ( IARC ) based in Lyon .
(7) JO No C 184 , 23.7.1986 , page 19
(8) JO No C 50 , 26.2.1987 , page 1
 ---pagebreak---                               3
     The latter Agency has been engaged since 1971 in evaluating the
     carcinogenic risks to man of individual chemical substances and
     certain of their compounds . As matters stand at present , of the
     107 substances , groups of products or industrial processes for
     which there have been epidemiological studies , 39 have been shown
     to be carcinogenic to man and a further 68 have been shown to be
     probably carcinogenic .
     The aim of the present draft Directive is to eliminate the
     differences which exist in Member States' legislation and to
     ensure greater protection for workers through the improvement of
     working methods and working conditions , of information and of
     human behaviour .
     The main laws and regulations currently in force in the Member
     States with regard to occupational exposure to carcinogens are
     described below .
Belgium
     Exposure of workers , whether by inhalation , ingestion or skin
     contact , is prohibited in respect of a certain number of
     substances or products containing these substances .
     A system of prior authorization exists for the use of these
     substances and a number of other substances , authorization being
     dependent on justification and on the existence of satisfactory
     working conditions .
     As regards asbestos and vinyl chloride , the EEC Directives have
     been assimilated into national legislation .
     There are restrictions on the use of benzene .
     Provisions also exist concerning medical surveillance , labelling ,
     and the information of workers .
 ---pagebreak---                                  4
     al Republie
Fédéral Rep. ib lie of Germany
     The manufacture and use of carcinogenic substances and prepara ¬
     tions are governed to a large extent by the Order on Dangerous
     Substances . The Order contains lists of carcinogenic substances ,
     broken down into three risk categories . The measures prescribed
     vary according to the risk category . The provisions cover the
     obligation     to  notify the authorities , substitute  substances ,
     restrictions on use , determination and assessment of the risk ,
     notably on the basis of the reference values , prohibition of
     exposure in the case of specific carcinogenic agents , adaptation
     of   working      methods to technical progress ,    provision   of
     information to workers , and choice of job assignment on the basis
     of medical surveillance . The list at present contains some 60
     substances . Mandatory reference values have been fixed for the
     most industrially important substances . These reference values
     take account of technical progress and are subject to regular re¬
     examination .
Denmark
     The National Inspection Services publish a list of substances
     regarded as carcinogenic to man in the list of Limit Values .
     In its present shape the list numbers about 200         substances ,
     listed alphabetically and identified by CAS codes .
     The substances require that there should be public information ,
     mandatory written handling instructions , and mandatory notifica¬
     tion to the Public Registry .
     Apart from this , limit values have been set , and there        are
     certain specific regulations , such as a ban on asbestos        and
     cytostatic drugs .
     There is at present no further general regulation on carcinogens .
 ---pagebreak---                                 5
Spain
      Legislation of a general nature includes :
           Royal Decree No of 23 October 1985 2216/85 ( the Presidency ).
           CHEMICAL PRODUCTS . Covers the notification of new substances
           and the classification , packaging and labelling of dangerous
           substances ( Spanish Official Gazette ( B.O.E. ) of 27.11.85 ).
           Defines the concepts of " carcinogenic ", " teratogenic " and
           " mutagenic " and    the   three   corresponding    categories
           identified by the IARC . Also defines the " R45 " risk ,
           although it is not applied to any substance . A three-year
           time-limit , starting from 1 March 1986 , is set for the
           enactment of specific provisions .
           Decree No 1995/ 78 of 12 May 1978 ( Ministry of Health and
           Social Security ). OCCUPATIONAL DISEASES . This decree lists
           16 types of cancerous diseases caused by chemical products
           and industrial processes .
      Regulations of a specific nature also exist ,   covering   benzene ,
      asbestos and vinyl chloride monomer .
France
      In addition to provisions of a general nature , such as the
      obligation to maintain proper standards of health and hygiene in
      work premises and working environments , specific legal provisions
      have been adopted in respect of ionizing radiation , benzene ,
      asbestos and vinyl chloride monomer . In these latter provisions ,
      prevention is based on observance of exposure limit values , these
      values being binding and subject to regular monitoring .
 ---pagebreak---                                6
     In addition , a circular on the prevention of occupationally
     induced cancer , issued on 14 May 1985 and updated periodically ,
     lists     certain products which are subject       to   appropriate
     preventive measures ; the list contains " not only products , agents
     or processes which are known to be carcinogenic to man , but also
     those which ,     in the absence of conclusive epidemiological
     evidence , have been adequately demonstrated to be carcinogenic to
     animals "; guideline exposure limit values are given in respect of
     certain of the agents or substances listed .
     Finally , the Order of 5 April 1985 lists substances liable       to
     cause a malignant lesion of the bladder .
Greece
     There is no specific legislation concerning the health and safety
     of workers with regard to carcinogens . However , Chapter 5 of Law
     No 1568/85 on Occupational Health and Safety lays down preventive
     measures and other general obligations for the protection of
     workers against chemical substances ( which naturally include
     carcinogens ). The Ministry of Labour is endeavouring to specify
     the general principles of prevention by laying down exposure
     limit values for chemical substances ( limit values had already
     been  laid down for certain chemical substances    in  Presidential
     Decree No 307 / 1986 ).
     At the same time , the question of the fixing of limit values for
     certain carcinogenic substances has been laid before the Council
     for Health and Safety at Work , but no final decisions have yet
     been taken .
     Finally ,    a number of specific provisions exist , including
     specific    decrees on the protection of workers against vinyl
     chloride , benzene and asbestos .
 ---pagebreak---                                  7
Ireland
     There is no law or regulation which lays down limit values .
     According to the legislation , persons covered by the Safety in
      Industry Acts 1955/1980 must not be exposed to dust or fumes at
      levels liable to be harmful to health . For the purpose of inter¬
     preting these provisions various sources may be used : either the
     values published by the ACGIH , or the workplace exposure limit
     values drawn up by the United Kingdom 's Health and Safety
     Executive , or the values adopted by the European Community .
     Dichloro-benzidine ,    however ,   is   covered by the Factories
      ( Carcinogenic Substances ) Processes Regulations , 1972 . According
      to these regulations , appropriate measures must be taken to
      protect personnel from any risk of inhalation , ingestion or other
      form of absorption of dichloro-benzidine .
Italy
      There   are no specific laws or regulations governing carcinogens .
      Technical prevention is governed 'by Articles 20 and 21 of
      Presidential   Decree  No 303 of 19 March 1956 ,   under  which  the
      employer is obliged to prevent or minimize the emission and
      dispersion of harmful pollutants of any kind .           The Labour
      Inspector adapts these regulations to specific cases , including
      carcinogens , exposure to which must be " zero or minimal ". As
      regards the carcinogenicity of substances , reference is made to
      the lists published by the international agencies , such as IARC ,
      and to the monographs published by the Ministry of Health 's
      National Consultative Committee on Toxicology .
      The same Presidential Decree provides for workers exposed to
      carcinogens    to be given six-monthly medical         examinations ,
      supplemented by various other examinations , which only the
      monitoring body , however , may make obligatory .
 ---pagebreak---                                 8
     There also exist provisions concerned specifically - and on a
     limitative basis - with prevention of the risks inherent in
     carcinogenic substances . These provisions , contained in Circulars
     No 49 of 12 June 1979 and No 61 of 4 June 1981 published by the
     Ministry of Labour , apply to a group of approximately 300
     aromatic amines which have been shown , in varying degrees , to be
     potentially carcinogenic . The provisions , which are very detailed
     and complex ,   apply three different levels of         stringency ,
     depending on the degree of carcinogenicity of each substance as
     evaluated by the National Committee on Toxicology .
Luxembourg
     Luxembourg has no specific legislation on carcinogenic substances
     at the workplace , nor is any such legislation being considered at
     present .
     Given that Luxembourg has no major chemical industry , the
     question of protection against dangerous substances is not as
     urgent as in other countries . Moreover , preference is given to
     regulations which are aimed at all dangerous substances and not
     limited to those with carcinogenic properties .
Netherlands
     On the basis of the opinion issued by the National MAC Committee
     the Directorate-General of Labour drew up a policy on carcino¬
     genic substances in 1984 .
     The policy is based on a general approach to groups of carcino¬
     genic substances , with a more specific approach to certain indi ¬
     vidual substances .
     In view of the fact that , unlike other toxic substances , no limit
     values can be given for most carcinogenic substances for which
     the health risk is zero , the measures will primarily aim to
     replace the substance with something less harmful . Where the
     substance cannot be replaced , in order to prevent or reduce
     exposure to carcinogens to minimize the health risk , measures are
     proposed .
 ---pagebreak---                                  9
     These measures are part of the general toxic substances policy .
     Other measures proposed for all of the carcinogen group include
     an obligation to label carcinogens , which will be in line with
     the EEC rules being prepared , and the registration of carcinogens
     by individual companies .
Portugal
     With the exception of legislation on ionizing radiation , there
     are no provisions in Portugal relating specifically to carcino¬
     genic substances at work . Exposure to carcinogens is still
     governed by general legislation on health and safety at work and
     occupational health .
     A law passed in 1985 contains a list of 28 substances             or
     industrial processes regarded as carcinogenic to man .
     An interministerial working party is at present preparing the
     draft regulations for a number of carcinogenic substances in a
     pure form .
     Council Directive 80 / 1107 /EEC and ILO Convention 139 are the main
     points of reference for this work .
United Kingdom
     The Carcinogenic Substances Regulations 1967 prohibit importation
     into the UK , and employment in the manufacture and use of four
     substances ( 2-naphthylamine , benzidine , 4-aminodiphenyl and 4 -
     nitrodiphenyl and their salts ).         In relation to six other
     carcinogenic substances       ( alphanaphthylamine , ortho-tolidine ,
     dianisidine , dichlorobenzidine and their salts , and auramine and
     magenta ) the Regulations require that all practicable steps be
     taken to prevent workers being exposed to them , that information
     be given to workers about the substances , that the substances be
     kept in properly closed and labelled containers , and that the
     workers be medically examined every six months .
 ---pagebreak---                                 10
    The     Patent Fuel Manufacture ( Health and Welfare )      Special
    Regulations 1946 are a limited set of regulations requiring
    control of exposure to coal dust ,          tar and pitch in the
    manufacture of fuel blocks , together with adequate washing
    facilities ,     protective    clothing and    six-monthly  medical
    examination .
    Otherwise , carcinogenic substances are treated as other toxic
    substances ( dusts , fume , vapour ) and all practicable measures
    have to be taken to prevent inhalation ( Section 63 , Factories Act
    1961 ); they are also subject to the general provisions of Section
    2 of the Health and Safety at Work etc . Act 1974 , which requires
    employers to protect workers' health so far as reasonably practi¬
    cable , in particular by use of proper plant , systems of work ,
    safe handling , storage and transport , provision of information ,
    instruction and training .
    The draft Control of Substances Hazardous to Health Regulations ,
    with its Approved Code of Practice for Carcinogens , will super¬
    sede the foregoing requirements .
3.  General principles of the proposai
    Since 1984 , following the adoption by the Council of the
    Directive adapting to technical progress for the fifth time
    Council Directive 67/ 548/EEC on the approximation of the laws ,
    regulations      and administrative provisions relating to      the
    classification , packaging and labelling of dangerous substances
     ( 9 ), the Commission of the European Communities has been working
    on the classification and labelling of chemical substances
    suspected of being carcinogenic .
    In order to speed up the work of classification , Member States
    which     have information justifying the classification of a
    substance as carcinogenic , whether submitted by the manufacturer
    or not ,      are required to forward such information to the
    Commission as soon as possible .
(9) OJ No L 257 , 16.9.1983 , page 1
 ---pagebreak---                           11
The classification decisions are then taken by the Commission ,
assisted by a national committee of experts . Substances are
divided into three categories :
" Category 1
Substances   known to be carcinogenic to man . There is sufficient
evidence to establish a causal association between human exposure
to a substance and the development of cancer .
Category 2
Substances which should be regarded as if they are carcinogenic
to man . There is sufficient evidence to provide a strong
presumption that human exposure to a substance may result in the
development of cancer , generally on the basis of :
      appropriate long-term animal studies ;
      other relevant information .
Category 3
Substances which cause concern for man owing to possible carcino¬
genic effects but in respect of which the available information
is not adequate for making a satisfactory assessment . There is
some evidence from appropriate animal studies , but this is
insufficient to place the substance in Category 2 .
The   following  specific risk phrases apply in respect  of  these
three categories :
Categories 1 and 2 :
R 45       May cause cancer .
 ---pagebreak---                               12
   Category 3
   R 40        Possible risk of irreversible effects ."
   In accordance with the aforementioned Proposal for a plan of
   action 1987-1989 presented by the Commission to the Council as
   part of the " Europe against cancer " programme ( 8 ), the work of
   classification and labelling will be speeded up in the years 1987
   to 1989 in order to achieve 50 evaluations per year . This means
   that by the end of 1989 approximately 200 substances will have
   been studied .
   In the light also of the opinion given by the Advisory Committee
   on Safety , Hygiene and Health Protection at Work concerning the
   strategy to be followed for the protection of workers against
   carcinogens , the Commission 's proposal relates to exposure to an
   initial list of carcinogenic agents already assigned to Catego¬
   ries 1 and 2 of the above-mentioned classification . This list
   will be added to as new substances are classified and labelled .
   The    industrial  processes  evaluated  by  IARC    and  at  present
   recognized as responsible for increasing the risk         to  workers
   involved in them are also covered by this proposal .
4. Description of the proposai
   Article    1 states that the aim of the Directive is to protect
   workers    against risks to their health arising from exposure at
   work .
   Article 2 defines the term " carcinogen ".
   Article 3 describes the scope of the Directive .      In the case  of
   any activity the risk must be assessed .
 ---pagebreak---                           13
Article 4 describes the measures to be taken to avoid exposure of
workers . Where such measures are not reasonably practicable ,
employers must take additional measures , such as limitation of
the number of workers exposed , optimum design of work processes ,
procedures for the early detection of abnormal           exposures ,
protective measures , provision of information for workers , health
surveillance of workers , emergency measures , and safe treatment
of stocks and waste .
Article 5 specifies the information which the employer must keep
available for the responsible authorities of the Member States .
Article 6 lays down the technical arrangements and personal
protective measures to be adopted in the event of an unfore¬
seeable occurrence which is likely to result in an abnormal
increase in the exposure of workers .
Article 7 obliges the employer to take all necessary measures for
the protection of workers involved in certain activities in
respect of which a significant increase in exposure is foreseeable .
Article    8 imposes restrictions on access to places         where
activities involving carcinogenic agents take place .
Article 9 describes the measures to be taken to provide workers
with rest and refreshment areas , washing and toilet facilities ,
and facilities for the storage of street clothes and working
clothes and personal protective equipment .
Article 10 stipulates that workers must receive adequate informa¬
tion and regular training concerning the potential risks to
health , hygiene requirements , the use of protective equipment and
the procedures to follow in the event of an incident .
Article 11 stipulates that measures shall be taken to ensure that
workers can check that the Directive is being properly applied
and that they receive information on the potential risks to
health from abnormal exposure .
 ---pagebreak---                              14
   The employer is obliged to keep a list of the workers exposed , to
   which the doctor and/or the responsible authority , and of course
   the worker himself , can have access .
   Article 12 sets out the requirements regarding health surveillan¬
   ce of workers and refers to the practical recommendations given
   in Annex III . The article also stipulates that individual records
   shall be established containing the worker 's health data , which
   may also be collected after the termination of exposure .
   Article   13 requires that the health records and the list of
   workers   exposed be kept for at least 30 years following the end
   of exposure .
   Article 14 concerns the keeping by Member States of statistics of
   recognized cases of occupational diseases due to carcinogens .
   Article   15  sets  out  the  time   limits and   the methods  for
   implementing this Directive in the Member States .
   Article 16 indicates to whom the Directive is addressed .
   Annex 1 lists the carcinogenic agents covered by the Directive ;
   the list also gives the numbers attributed by the CAS and/or the
   EEC , as well as the chemical formula of each agent .
   Annex 2 lists the industrial processes covered by the Directive .
   Annex 3 sets out practical recommendations for the health
   surveillance of workers exposed to the agents and processes
   listed in Annexes 1 and 2 .
5. Consultation
   In accordance with Article 21 of the Single European Act , which ,
   together with Article 118A , supplements the Treaty establishing
   the European Economic Community , the European Parliament and the
   Economic and Social Committee must be consulted .
 ---pagebreak---                                         Λ
                                   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 )
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having     regard  to   the Treaty establishing      the   European    Economic
Community , and in particular Article     118 A thereof ,
Having     regard to the proposal from the Commission , drafted
following consultation with the Advisory               Committee   on   Safety ,
Hygiene and Health Protection at Work ,
In cooperation with the European Parliament ,
Having     regard to the Opinion of the Economic and        Social    Committee ,
Whereas , pursuant to Article 118 A of the Treaty , the Council shall
adopt , by means of directives , minimum requirements in order to
 encourage improvements , especially in the working environment , as
regards the health and safety of workers ,
 ---pagebreak---                                              2
Whereas the Council resolution of 27 February 1984 on a second
action programme of the European Communities on safety and health at
work    (1 )   provides for the development of 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 exposure to
chemical , physical and biological agents at work ( 2 ) laid down such
principles which have to be taken into account for such protection ;
Whereas , under the terms of the said Directive , such protection
should as far as possible be ensured by measures to prevent exposure
or to keep it at as low a level as is reasonably practicable ;
Whereas      Council Directive 67/ 548/EEC of 27 June 1967 on the approximation of Laws,
regulations and administrative provisions relating to the classifi ¬
cation , packaging and labelling of dangerous substances contains a
list of dangerous substances , together with particulars of the
classification          and labelling procedures in respect                  of    each
substance ; whereas this list has been adapted in the light of
scientific and technical knowledge, most recently by Directive 87/432/EEC^;
Whereas the proposal for a plan of action 1987 to 1989 contained in
the " Europe against cancer " programme ( 5 ) provides for                  Directives
for the protection of workers against carcinogenic 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 th se
risks ;
Whereas employers must keep abreast of new developments in techno¬
logy with a view to improving the protection of workers' health and
safety ;
Whereas       preventive measures should be taken for the protection of
the health and safety of workers exposed to carcinogens ;
1)    OJ No C 67 , 8.3.1984 , p. 2 .
2)    OJ No L 327 , 3.12.1980 , p. 8 .
3 ) OJ No 196 , 16.8.1967 , p.1
4 ) OJ No L 239 , 21.8.1987, p.1
5 ) OJ No C 50 , 26.2.1987 , p.1
 ---pagebreak---                                     3
Whereas it is necessary , in order to ensure the highest degree of
protection reasonably practicable , that workers and their repre¬
sentatives be informed about the risks which carcinogens can pose
for their health and about the measures necessary to lessen or eliminate
those risks and that they should be in a position to ensure that the
necessary protective measures are taken ,
 ---pagebreak---                                  4
HAS ADOPTED THIS DIRECTIVE :
                               OBJECTIVE
                               Article 1
1.   This Directive ,   which is the sixth individual Directive within
     the meaning of Article 8 of Directive 80/1107/EEC , 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 carcinogens at work .
2.   This  Directive    shall  not apply to   workers
          engaged in sea transport       and in air transport . For the
          purpose     of this Directive "workers engaged in         sea
          transport and in air transport " means personnel on board .
          exposed only to ionizing radiations .
                               DEFINITION
                               Article 2
For the purposes of this Directive , a carcinogen is :
     a chemical agent as designated in Annex I by its number in the
     Chemical Abstracts Service register
     an industrial process as designated in Annex II .
 ---pagebreak---                               5
                           ASSESSMENT
                           Article 3
This Directive shall apply to activities in which workers are
or are likely to be exposed to carcinogens as a result of their
work .
In the case of any activity or sector of activity likely to
involve a risk of exposure to carcinogens the risk must be
assessed in such a way as to determine the nature and degree of
the workers ' exposure .
                         PREVENTION OF EXPOSURE
                           Article 4
In the case of any activity or sector of activity likely to
involve a risk of exposure to a carcinogen the exposure of
workers shall be prevented in so far as is reasonably practi¬
cable - by ensuring that the production and
use of that carcinogen take place in a closed system .
    Employers shall make the necessary arrangements to identify
    any activity or sector of activity in which it is not reaso¬
    nably practicable to use a closed system . In all case the
    exposure of workers must be reduced to as low a level as is
    reasonably practicable, in particular through the use of some
    or all of the following measures as appropriate :
 ( a)  limitation of the use of a carcinogen at the place of
       work , in particular by its replacement by another agent or
       process which is less dangerous to           workers' health ;
 (b)   limitation of the number of workers exposed or likely          to
       be exposed ;
 (c)         design  of  work processes        and engineering  control
       measures   so  as  to avoid or to minimize the       release   of
       carcinogens into the place of work ;
 ---pagebreak---                               6
(d)       use of adequate measurement procedures for carcino¬
     genic agents , in particular for the early detection of
     abnormal    exposures    due  to   an   unforeseeable      event  or an
     accident ;
(e)         application    of   suitable    working   procedures      and
     methods ;
(f)  collective protection measures ;
(g)  individual protection measures , where           exposure     cannot
     reasonably be avoided by other means ;
(h)  hygiene measures ;
(i)  information for workers ;
(j ) use of warning and safety signs including " no smoking "
     signs in areas where workers are exposed or likely to be
     exposed to carcinogens ;
(k)  surveillance of the health of workers ;
(l)        keeping of updated lists of workers exposed or likely
     to be exposed and of health surveillance records ;
(m)  emergency measures for abnormal exposures ;
(n)  means     for   adequate     safe     storage ,     handling     and
     transportation , in particular by using sealed and properly
     labelled containers .
(o)  means for safe collection ,      storage and disposal of waste ,
     including the use of sealed and properly labelled containers.
 ---pagebreak---                                          7
               INFORMATION FOR THE          COMPETENT  . AUTHORITIES
                                      Article 5
For   every    activity referred to in Article 3(1 ),           employers    shall ,
when so requested, make available to the competent             authorities appro­
priate information on :
      the    activities and/or industrial processes carried                     out ,
      including the reasons for which carcinogens are used ;
      the quantities of substances or preparations               manufactured     or
      used which contain carcinogenic agents ;
      the number of workers exposed ;
-     the preventive measures taken ;
      the type of protective equipment used .
                                 ABNORMAL EXPOSURES
                                      Article 6
In   the   event    of an unforeseeable event or an           accident    which   is
likely to result in an abnormal exposure of workers :
( a)  only those workers who are required to take remedial action and
      carry out other necessary work shall be permitted to work in
      the affected zone ;
(b)   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 ;
 (c)  unprotected      workers      shall    not   be allowed   to   work   in   the
      affected areas until the situation has been restored to normal ,
      and   the causes for the increase eliminated .
 ---pagebreak---                                        8
                                    Article 7
For certain activities such as maintenance , in respect of which it
is foreseeable that there will be a significant increase in exposure
of workers , and in respect of which further technical preventive
measures for limiting workers 1 exposure are not reasonably practi ¬
cable , the employer shall determine the collective measures intended
to reduce the duration of workers' exposure to the minimum possible
and to ensure adequate protection of workers while they are engaged
in such activities .
In particular , Article 6            . ( b ) shall apply .
                                ACCESS TO AREAS
                                    Article 8
Appropriate measures shall be taken to ensure that access to the
places in which the activities referred to in Article 3 (1) take place
is restricted solely to workers who , by reason of their work or
duties , are required to enter them .
                     PROTECTIVE CLOTHING AND EQUIPMENT
                                    Article 9
1.    Appropriate measures shall be taken ,          where this is reasonably
      practicable, to ensure that :
       (a) workers do not eat , drink or smoke in working areas where
           there is a risk of contamination by carcinogens ;
       (b)  (i)    workers are provided with appropriate protective
                   clothing or other appropriate special clothing ;
            ( ii ) separate storage places are provided for working        or
                   protective clothing and for street clothes ;
 ---pagebreak--- (c )  workers are provided with appropriate and adequate washing
      and toilet facilities , including showers in the case of
      dusty operations ;
(d)   protective equipment is properly stored in a well-defined
      place and is checked and cleaned if possible before , and
      in  any case after, each use ;   defective equipment shall be
      repaired or replaced before further use .
Workers may not be charged for the cost of these measures .
                   INFORMATION AND TRAINING
                            Article 10
Appropriate measures shall be taken by the employer to ensure
that workers and/or any workers' representatives in .the undertaking
or establishment          .                receive adequate infor-   infor­
mation , regular training and instructions concerning :
( a)  potential risks to health ,
(b)   the 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 .
Employers    shall ensure that workers are adequately informed of
installations and related containers containing carcinogens and
that , where appropriate , such information takes the form of
suitable warning and hazard signs .
 ---pagebreak---                               Artide 11
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 be involved in its application , in
     particular with the selection, wearing and use of protective
     clothing and equipment ;
(b)  workers and/or any workers' representatives in the undertaking
     or establishment .                   are informed as quickly as
     possible of abnormal exposure , of the causes thereof        and of
     the measures taken or to be taken to rectify the situation ;
(c ) the employer keeps a list of the workers engaged in the activi ¬
     ties referred to in Article 3(1 ), indicating where appropriate the
     exposure to which they may 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 at ( c );
(e)  each   worker  has access to the information in 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 ;
(g)  workers   and/or any workers' representatives in the undertaking
     or establishment                     can receive information       on
     the potential risks to health from exposure to carcinogens .
 ---pagebreak---                                  11
                          HEALTH SURVEILLANCE
                               Article 12
1. Special      arrangements for carrying out the relevant health
   surveillance       of workers exposed to carcinogens shall be
   established by the Member States in accordance with 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 undergo an
   assessment of his state of health :
         prior to exposure ;
   -     at regular intervals thereafter .
   This assessment shall be such that it is directly possible          to
   implement hygiene and individual measures .
3. If a worker is found to be suffering from an abnormality which
   is suspected to bei         the result of exposure to carcinogens ,
   the doctor or the authority competent, for the health surveillance
   of         workers may require other workers who have been
   similarly exposed to undergo health surveillance ,            and 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  indivi ¬
   dual   health     record shall be kept and the doctor or the authority competent
   for health surveillance shall propose any protective or preven¬
   tive measures to be taken in respect of any individual worker .
5.  Information and advice must be given to workers regarding any
   health surveillance which they may undergo following the end of
   exposure .
6. The   workers concerned or the employer may request a review        of
    the assessment referred to in this Article ,     in accordance with
    national lav/s and practice .
7.  Practical     recommendations   for  the  health  surveillance     of
   v/orkers    is   given in Annex III . Those recommendations may be
    adapted   in    the light of technical progress as provided for in
    Article 10 of Directive 80/ 1107 /EEC .
 ---pagebreak---                                 - 12
                              RECORD KEEPTNG
                                Article 13
The following measures shall be taken :
1.   The   list   referred to in Article 11(c ) and the   health    record
     referred    to  in Article 12(4 ) shall be kept for   at   least    30
     years following the end of exposure ,    in accordance with natio¬
     nal laws and practice .
2.   These   records   shall   be made  available  to   the competent
     authority in cases where the undertaking ceases its activity, in
     accordance with national laws and practice .
                           NATIONAL STATISTICS
                                Article 14
Member States shall keep national statistics of recognized cases of
occupational diseases due to carcinogens .
                             FINAL PROVISIONS
                                Article 15
1.   Member States shall adopt the laws , regulations and adminis­
     trative provisions necessary to comply with this Directive
     by       31 December 1989 . They shall immediately inform the
     Commission thereof .
2.   Member     States   shall   communicate  to  the   Commission      the
     provisions of national law which they        adopt   in   the    field
     governed by this Directive .
                                Artide 16
This Directive is addressed to the Member States .
                                           Done at Brussels
                                                  For the Council
                                                   The President
 ---pagebreak---                                             13
                                                                    ANNEX I
                               List of carcinogenic agents
     ( to which reference is made in Article 2 and Article 3(3)and ( 4 ))
   CAS1 No         !    EEC No                      Nome of agent             Formula
   of agent        ! of agent
                   1
                   1
                   1
 1 00107 - 13 -1 i 608 - 003 -00 -4    Acrylonitrile                        C3H3N
 2 01327 - 53 -3 1033-003 - 00 - 0     Arsenic trioxide                     AS203
                   1
 3 00542 -88 -1 1603 -046 -00 - 5      Bis ( chlorcmethyl ) ether           C2H4C12°
 4 10108-64 -2 1048-008 - 00 - 3       Cadmium chloride                     CdCl2
 5 13765 - 19 - 0 1024 - 008 - 00- 9   Calcium chromate                     CaCrO „
 6 00107 - 30- 2 ¡603 - 075-00 - 3     Chloromethyl methyl ether            C2H5CIO
 7 00096 -12 -8 1602 - 021- 00 - 6     1 , 2-dibromo-3-chloropropane        C3H5Br2Cl
 8 00091- 94 - 1 1612 - 068 - 00 -4    3,3' -dichlorobenzidine              C12H10C12N2
 9        -
                   1612 -069 - 00 -X   Salts of 3,3'-dichloro-              C12H10C12N2
                    1                  benzidine
                    1
10 00064 - 67 - 5 1016- 027 - 00 - 6   Diethyl sulphate                     C4H10°4S
11 00079 -44 - 7 ¡006 - 041 - 00 -0    Dimethylcarbamoyl chloride           COH,C1N0
                                                                             O O
12 00057 - 14 - 7 ¡007 -012 - 00 - 5   N, N-dimethylhydrazine               C2H8N2
13 00077 - 78- 1 1016 - 023 - 00 -4    Dimethyl sulphate                    C2H6°4S
14 00106 -89-8 1603 - 026-00 - 6       Epichlorohydrin                      C3K5C10
15  00106 - 93 -4 ¡602 - 010 -00 - 6   Ethylene dibromide                   C2H4Br2
16  00075 -21 -8 1603 - 023 - 00 -X    Ethylene oxide                       C2H4O
17  00580 -31 - 9 1015- 106 -00 -2     Hexamethylphosphoric triamide        C6H18N30P
18  00101- 14 -4 Í 612 - 078 - 00-9    4 , 4 ' -methylene bis
                      1                         ( 2-chloroaniline )         C13H12C12N2
                      !
19  00602 - 87 - 9 ! 609 - 037 -00 - 2  5-nitroacenaphthene                 C12H9N02
20  00581 - 89 - 5 1609 - 038-00-8      2-nitronaphthalene                  C10H il'°2
21  00079 -46 - 9 1609 -002 -00-1       2-nitropropane                      C3H7N02
22  00062 - 75 - 9 1612 - 077 -00-3    N-nitrosodimethylamine               C2H6N2°
 ---pagebreak---                                                  ' ’Ι
23 1 Coli 9 - 90-4     612 - ü.?6 - 0Q -X o-dian*?. IcLne            С,1-1 16^ N,.0..
                                                                                    2 2
     !
24    1     •
                       612 - 037 -C0 - 5  Sait of o-dianisidine       C.1«. H 1?
                                                                              , ,.Iïo0o
                                                                                    2 2
     I
25   I  01120 - 71 -4  OIS -C32 -00 - 3   1 , S-propane ultone        C,H.-0,S
                                                                        3 o _>
     !
26   !  00057 -57 -8   606 - 031- 00 - 1  F::opanolide                C H O
                                                                        3 4 '2
     !
27   !  00075 - 55 - 8 613 - 033 - 00 - 6 Propyleneimine              C3H?N
     !
28   1  07789 -06-2    024 -009 - 00-4    Strontium chromate          CrO.Sr
                                                                            4
     !
29   !  00119 - 93 - 7 612 -041-00 -7     o-tolidine                  C14H16N2
     Í
30   !      -
                       612 - 081-00 - 5   Sait of o-tolidine          C14H16N2
     !
31   !  13550- 65-9    024 -007 -00 -3    Zinc chromate               CrO^Zn
( 1 ) Number in the register of the Chemical Abstract Service ( CAS )
 ---pagebreak---                                     l<
                                                                ANNEX II
INDUSTRIAL PROCESSES                   AGENTS PROBABLY CONCERNED
1 . Auramine manufacture               Auramine
2 . Boot and shoe manufacture          Leather dust
    ( certain occupations )
3 . Coal gasification ( older          Coal tar and coal tar fumes
    processes )                        Certain hydrocarbons polynuclear
                                          aromatic
4 . Coke production                    Coal tar and coal tar fumes
                                       Certain hydrocarbonspolynuclear
                                          aromatic
5 . Furniture manufacture ( wood       Certain wood dusts
    dust )
6 . Isopropyl alcohol manufacture      Isopropyl alcohol
    ( strong acid process )
7 . Nickel refining                    Nickel subsulphide
                                       Nickel oxides
8 . Rubber industry ( certain          Certain aromatic amines
    occupations , such as milling ,    Certain organic solvents
    extruding and vulcanization )
 ---pagebreak---                                                         ANNEX III
   Practical recommendations for the health surveillance
        of workers , as referred to in Article 12 ( 7 )
The doctor and/or authority competent      for the health surveil­
lance of workers exposed to carcinogens must be familiar with the
exposure conditions or circumstances of each worker .
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 .
 ---pagebreak---                                   (>
              IMPACT STATEMENT ON COMPETITION AND EMPLOYMENT
I.    The main purpose of the proposed Council Directive is to protect
      workers in Member States against the risks related to exposure to
      carcinogens at work .
II .  The sectors of industry which are mainly affected by the    Directive
      are :
      Chemicals
      Fibre Manufacture
      Sterilising Agents
      Crystal Glass
      Wood Preservative
      Laboratories
III . This directive avoids imposing administrative financial and legal
      constraints in a way which would hold back the creation and
      development of small and medium sized undertakings . From the point
      of view of costs , the most important articles concern :
            elimination or reduction of workers' exposure ,
            storage of carcinogens ,
            specific   measures to be taken for workers        exposed   to
            carcinogens ,
            health surveillance .
      Of these , the most important direct costs are related to health
      surveillance . To reduce these costs to a minimum , the obligations
      concerning health surveillance have been modified to fit in as    far
      as possible with existing systems .
IV .  The benefits from improvements in working conditions result from a
      reduction in the numbers of cancers . These improvements will
      benefit not only individuals in society as a whole but also
      individual businesses . In the latter case reduced costs result from
            less sickness absence
            less rehabilitation costs , and
            fewer ill-health retirements
V.    The Advisory Committee for Safety Hygiene and Health Protection
      at Work , gave its opinion on 2 and 3 July 1987 , and was in
      favour of the contents of the proposal for a Directive .