CELEX: 51996PC0414
Language: en
Date: 1996-07-24
Title: Amended Proposal for a Council Directive amending for the first time Directive 90/394/EEC on the protection of workers from the risks related to exposure to carcinogens at work

COMMISSION OF THE EUROPEAN COMMUNITIES
                                                Brussels, 24.07 1996
                                                COM(96) 414 final
                                                95/0229 (SYN)
                      OPINION OF THE COMMISSION
          on the amendments proposed by the European Parliament
                   to the Council's common position on the
                                 proposal for a
                           COUNCIL DIRECTIVE
         on the protection of workers from the risks related to
                        exposure to carcinogens at work
(presented by the Commission pursuant to Article 189 c (d) of the EC Treaty)
 ---pagebreak---  ---pagebreak---                            EXPLANATORY MEMORANDUM
 The initial proposal for this amendment to the Directive was presented by the
 Commission to the Council on 14 September 19951.
 The main aims are the removal of the existing exclusion in Directive 90/394/EEC of a
 whole series of preparations containing carcinogens and the laying down of a limit value
 for occupational exposure to benzene, a well-known carcinogen.
 The European Parliament and the Economic and Social Committee gave their opinion
 on 20 June 19962 and 31 January 19963 respectively.
 In drawing up this amended proposal, the Commission took into account for the most
 part the amendments from the European Parliament and suggestions put forward by the
 Economic and Social Committee, and in particular:
 a)      the role of biological monitoring in health surveillance for exposed workers;
 b)      the need for coherence with other Community acts on the same subject;
 c)      the advisability of having a uniform method for measuring benzene
         concentrations in air and for analysis;
 d)      the advisability of including the derogation concerning primary synthesis in the
         production of materials for perfumes among the temporary derogations relating
         to limit values for benzene.
 This amendment is presented by the Commission under the terms of Article 189a(2) of
  the Treaty.
1
        OJ C 317, 28.11.1995, p.16.
        OJ
        OJ C 97, 1.04.1996, p.25.
 ---pagebreak---                                             A
                        Amended Proposal for a Council Directive
                    amending for the first time Directive 90/394/EEC
                          on the protection of workers from the
                     risks related to exposure to carcinogens at work
                                 (Text with EEA relevance)
       COMMISSION PROPOSAL                              AMENDED COMMISSION
                                                               PROPOSAL
THE COUNCIL OF THE EUROPEAN                       THE COUNCIL OF THE EUROPEAN
UNION,                                            UNION,
Having regard to the Treaty establishing
the European Union, and in particular
Article 118a thereof,
Having regard to Council Directive
90/394/EEC of 28 June 1990 on the
protection of workers from therisksrelated
to exposure to carcinogens at work(1), and
in particular Article 16,
Having regard to the proposal from the
Commission^), drawn up following
consultation with the Advisory Committee
on Safety, Hygiene and Health Protection
at Work,
In cooperation       with   the    European
Parliament(3),
 ---pagebreak---                                             1
Having regard to the opinion of the
Economic and Social Committee(4),
Whereas Article 118a of the Treaty
provides that the Council shall adopt, by
means of directives,             minimum
requirements for            encouraging
improvements, especially in the working
environment, to ensure a better level of
protection of the safety and health of
workers;
Whereas, under the terms of that Article,
such directives are to avoid imposing
administrative, financial and legal
constraints in a way which would hold
back the creation and development of
 small and medium-sized undertakings,
                                              Whereas the Commission's communication
                                              on its programme in the field of safety,
                                              hygiene and health at the workplace (1996-
                                              2000)(5) provides in particular for the
                                              continuation of work on setting limit
                                              values for exposure at the workplace;
 Whereas Commission              Directive
 91/325/EEC(6) of 1 March 1991 adapting
 to technical progress for the twelfth time
 Council Directive 67/548/EECO on the
 approximation of the laws, regulations and
 administrative provisions relating to the
 classification, packaging and labelling of
 dangerous substances introduces in Annex
 in new risk phrases to indicate the health
 hazards resulting from prolonged exposure
 and the risk of cancer through inhalation;
 ---pagebreak--- Whereas in all work situations workers       Whereas in all work situations workers
must be protected in respect of              must be protected in respect of
preparations containing one or more          preparations containing one or more
carcinogens;                                 carcinogens and from carcinogenic
                                             compounds arising at work;
Whereas, for some agents it is necessary to
consider all absorption pathways, including
the possibility of penetration through the
skin, in order to ensure the best possible
level of protection;
 Whereas the wording of point 2 of Annex
 I to Directive 90/394/EEC relating to
 polycyclic aromatic hydrocarbons has
 posed problems of interpretation in many
 Member States; whereas, therefore, a new,
 more precise wording is called for;
 Whereas Article 16 of the aforementioned
 Council Directive 90/394/EEC makes
 provision for the establishment of exposure
 limit values on the basis of the available
 information, including scientific and
 technical data, in respect of all those
 carcinogens for which this is possible;
 Whereas occupational exposure limit
 values must be regarded as an important
 component of the general arrangements for
 the protection of workers; whereas such
 limit values must be revised whenever this
 becomes necessary in the light of more
 recent scientific data;
 ---pagebreak--- Whereas benzene is a carcinogen which is      Whereas benzene is a carcinogen which is
present in many work situations whereas,      present in many work situations; whereas,
therefore, a large number of workers are      therefore, a large number of workers are
exposed to a potential healthrisk;whereas,    exposed to a potential healthrisk;whereas,
although current scientific knowledge is      although current scientific knowledge
not such that a level can be established      classifies benzene among the substances
below which risks to health cease to exist,   for which a level cannot be established
a reduction in exposure to benzene will       below which risks to health cease to exist,
nonetheless reduce these risks;               a reduction in exposure to benzene will
                                              nonetheless reduce these risks;
                                              Whereas it is important to set biological
                                              limit values to carcinogens in order to
                                              estimate the level of absorption of other
                                              routes than the breath. Because bio-
                                               monitoring is an important procedure for
                                              assessing benzene exposure, the
                                              Commission should propose a biological
                                               limit value for benzene without delay;
 Whereas the respect of the minimum           Whereas the respect of the minimum
 requirements on the protection of health     requirements on the protection of health
 and safety of workers from the specific      and safety of workers from the specific
 risks related to carcinogens ensures not     risks related to carcinogens aims not only
 only the protection of the health and safety to ensure the protection of the health and
 of each individual worker but also provides   safety of each individual worker but also
 a level of minimum protection of all         to provide a level of minimum protection
 workers in the Community which avoids         of all workers in the Community which
 any possible distortion in the area of        avoids any possible distortion in the area
 competitiveness;                              of competitiveness;
 ---pagebreak---                                             Whereas all the directives concerning
                                            protection of the health of workers at the
                                            place of work and the directives
                                            concerning protection of public health and
                                            of the general environment must reflect a
                                            single overall vision of socio-economic
                                            development in the European Community
                                            whereas the measures taken concerning
                                            benzene under the present Directive must
                                            therefore be consistent with the aims and
                                            provisions of Directive 94/63/EC(*) on the
                                            control of volatile organic compound
                                            emissions (and thus of benzene emissions)
                                            resulting from the storage of petrol and its
                                             distribution from terminals to service
                                             stations;
Whereas provision should be made to
ensure the protection of the health and
safety of workers concerned, in the case of
derogations provided for specified
activities or sector of activity where the
implementation of the limit value proposed
for benzene may be difficult to meet
within the date proposed;
Whereas in most small and medium sized
enterprises where the main use of benzene
might be as a solvent, provisions to lower
exposure will not be required as legal
provisions already exist in nearly all the
member States to restrict or prohibit its
use.
 ---pagebreak--- Whereas a consistent level of protection
from therisksrelated to carcinogens has to
be established for the Community as a
whole and whereas that level of protection
has to be set not by detailed prescriptive
requirements but by a framework of
general principles to enable Member States
to apply the minimum requirements
 consistently;
 Whereas this amendment constitutes a
 practical aspect of the realisation of the
 social dimension of the internal market;
 Whereas, pursuant to Decision
 74/325/EECO, as last amended by the
  1985 Act of Accession, the Advisory
 Committee on Safety, Hygiene and Health
 Protection at Work is to be consulted by
 the Commission with a view to drawing up
  proposals in this field,
 ---pagebreak---                             HAS ADOPTED THIS DIRECTIVE:
                  Article 1                             Article 1
Directive 90/394/EEC is hereby amended
as follows:
1. Article 2 shall be replaced by the
    following:
    "For the purposes of this Directive,
(a)    "carcinogen" means:
       i) a substance which meets the
           requirements for classification as
           category 1 or 2 carcinogen
            according to the criteria of
            Annex VI of Directive
            67/548/EEC(7).
       ii) a preparation composed of one
            or more substances referred to in
            point (a)i) where              the
            concentration of one or more of
            the individual substances meets
            the      requirements          for
            concentration limits for the
            classification of a preparation as
            a category 1 or 2 carcinogens set
            out either:
 ---pagebreak---               in Annex I to Directive
              67/548/EEC
              or
              in Annex I of Directive
              88/379/EEC(10) 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.
(b) "limit value" means, unless otherwise  (b) "limit value" means, unless otherwise
    specified, the limit of concentration      specified, the limit of concentration
    for a "carcinogen" in the air within       for a "carcinogen" within the
    the breathing zone of a worker."           breathing zone of a worker in
                                               relation to an appropriate reference
                                               period. Breathing zone is the space
                                               from where he takes his breath. It
                                               shall be forbidden to exceed this
                                               value.
                                           (c)  "biological limit value" means the
                                                limit of concentration in the
                                                appropriate biological medium, of the
                                                relevant agent, its metabolite, or an
                                                indicator of effect. It shall be
                                                forbidden to exceed this value.
 ---pagebreak--- 2.   Article 3(3) shall be replaced by the
     following:
     "Furthermore, when assessing the
     risk, account shall be taken of all
     other routes of exposure, such
     absorption into and/or through the
      skin".
3.    In Article 16, the following
      paragraph shall be added:
    "3. In the case of derogations provided
    for in Annex m, the Member States
    shall be obliged to ensure that
    employers comply with procedures
    and measures in order to take adequate
    precautions to protect the health and
    safety of the workers concerned."
 4. Item 2 of Annex I shall be replaced by
    the following:
    "Work involving exposure to
    polycyclic aromatic hydrocarbons
    present in coal soot, coal tar or coal
    pitch".
 5. Part A of Annex III shall be replaced
    by the following:
 ---pagebreak---                                                                 10
          "A. LIMIT VALUES FOR
      OCCUPATIONAL EXPOSURE
 Nome      Elnecs    CAS             Limit values       Notation                Derogations
 of agent (1)        (2)          nag/m1 (3) ppm (4)
 Benzene 200-753-7 71-43-2        3.25(5)    1(5)       Skin (6)      Limit value: 3 ppm
                                                                      (-9.75 mg/m') until 31
                                                                      December 2000 for the
                                                                      following activities or
                                                                      sector of activity:
                                                                          Selected sites in coke
                                                                          plants (primary coolers,
                                                                          benzol/suiphatehouses,
                                                                          benzol storage and
                                                                          loading)
                                                                      - cleaning and
                                                                          maintenance of tanks
                                                                          loading and unloading
                                                                          of tanker
                                                                          vessels and lorries
                                                                       • marine transport
                                                                       • motor vehicle repair
                                                                          shops
                                                                       - service station with
                                                                           filling
                                                                       - attendant
                             Nome      Elnecs     CAS           Limit values         Notation               Derogations         Biological
                             of agent (1)         (2)        mg/m1 (3) ppm (4)                                                     limit
                                                                                                                                 value<s)
                             Benzene 200-753-7 71-43-2       3.25 (5)   1 (5)        Skin (6)    Limit value: 3 ppm             p.m.
                                                                                                 (-9.75 mg/m1) until 31
                                                                                                 December 2000 for the
                                                                                                 following activities or sector
                                                                                                 of activity:
                                                                                                 • Selected sites in coke
                                                                                                     plants (primary coolers,
                                                                                                     benzol/sulphate houses,
                                                                                                     benzol storage and
                                                                                                     loading)
                                                                                                 • cleaning and maintenance
                                                                                                     of tanks
                                                                                                 • loading and unloading of
                                                                                                     tanker
                                                                                                 - vessels and lorries
                                                                                                 - marine transport
                                                                                                 - motor vehicle repair
                                                                                                     shops
                                                                                                 • service station with
                                                                                                     filling
                                                                                                     attendant
                                                                                                 - primary synthesis in
                                                                                                     fragance material
                                                                                                     production
(1)      EINECS: European Inventory of Existing Chemical Substances
(2)      CAS: Chemical Abstract Service Number
(3)      mg/m* - milligrams per cubic metre of air at 20 C and 101J KPa (760 mm mercury pressure)
(4)      ppm - parts per million by volume in air (ml/m*).
(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."
 ---pagebreak---                                             11
                                               Part B of Annex III shall be replaced by
                                               the following:
                                               "B. OTHER DIRECTLY              RELATED
                                               PROVISIONS
                                               Benzene
                                               For the measuring procedure, CEN
                                               689:1995 should be used preferentially.
                                                In the absence of a uniform analytical
                                                method, at Community level, Member
                                                States shall provide the method to be used.
                Article 2
1. Member States shall bring into force
   the laws, regulations and administrative
   provisions necessary to comply with
   this Directive not later than 31
   December 1998. They shall forthwith
   inform the Commission thereof.
   When Member States adopt these
   provisions, these shall contain a
   reference to this Directive or shall be
   accompanied by such reference at the
   time of their official publication. The
   procedure for such reference shall be
   laid down by the Member States.
2. Member States shall communicate to
   the Commission the texts of the
   provisions of national law which they
   adopt in the field covered by this
   Directive
 ---pagebreak---                                           12
                  Article 3
This Directive is addressed to the Member
States.
1. OJNoL 196, 26.7.1990, p. 1
2.    OJC317, 28.11.1995, p. 16
3. OJ
4. OJ C 97, 01.04.1996, p. 25
5. COM(95) 282 final
6. OJNoL 180, 8.7.1991, p. 1
7. OJNoL 196, 16.8.1967, p. 1
 8. OJ No L 365, 31.12.1994, p. 24
 9. OJ No L 185, 9.7.1974, p. 15
 10. OJ No L 187, 16.7.1988, p. 14
 ---pagebreak---                                                  U
                                                                    ISSN 0254-1475
                                                             COM(96) 414 final
                                              DOCUMENTS
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                                    Catalogue number : CB-CO-96-398-EN-C
                                                              ISBN 92-78-07688-0
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