CELEX: 51976PC0556
Language: en
Date: 1976-11-16
Title: Proposal for a COUNCIL DIRECTIVE on the approximation of Member States' laws, regulations and administrative provisions on the protection of the health of workers occupationally exposed to vinyl chloride monomer (submitted to the Council by the Commission)

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COM (76) 556
Vol. 1976/0171
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                             COM(76)556 final
                                             Brussels , 16th November 1976
                                Proposal for a
                              COUNCIL DIRECTIVE
      (- : L
                on the approximation of Member States' laws ,
             ^•regulations and administrative provisions on
             -   the protection of the health of workers occu­
               pationally
             "•Rationally exposed to vinyl chloride monomer
                  ( submitted to the Council by the Commission )
  C0MC76 ) 556 final
 ---pagebreak---                      MEMORANDUM
        on the draft proposal for a Council Directive on the
        approximation of Member States' laws , regulations and
        administrative provisions on the protection of the
        health of workers occupationally exposed to vinyl
        chloride monomer .
          Chi oro ethylene or vinyl chloride monomer (VCM ) is a
gaseous product and has been known for almost 150 years .
          Its polymer ( PVC ), which has been manufactured on a
commercial scale for over 40 years , forms together with
polyethylene a major sector of the chemical industry .
          In 1975 29 chemical companies in the countries of the
European Community produced 5 million tonnes of vinyl chloride
( YCM ) in 26 different factories and 4.5 million tonnes of the
polymer ( PVC ) in 35 factories . Of the persons employed in these
chemical plants some 10 000 are exposed to vinyl chloride
monomer .
          Processing into semi - fabricated and finished products
is done in some 5 700 plants by approximately 350 000 workers
who in 1973 produced goods worth 4 520 million u.a .
          Since the commercial production of vinyl chloride (VCM)
commenced around 1930 , we have known that gaseous vinyl chloride
has a narcotic effect . However , only very few cases of acut#
intoxication have been recorded .
2096/7 /75 e
 ---pagebreak---                            - II -
         Up to 1966 its chronic toxicity was thought to be low,
but since then an increasing number of publications have
appeared with reports of health impairment caused by VCM ex­
posure . The first reports were of a narcotic syndrome manifested
by asthenic and neurotic symptoms . These were accompanied by
digestive and liver troubles or neurovascular and skin diseases .
In 1967 cases were reported of acro-osteolysis in connection
with Raynaud 's syndrome .
         This was followed by a marked increase in animal ex­
periments and industrial hygiene monitoring on an international
scale . The malignant tumours found in both humans and animals ,
particularly liver tumours , brought worldwide reaction .
         Both national parliaments and the European Parliament ,
as well as employer and worker organizations held discussions
on the problems . The World Health Organizaion dealt with the
risk of cancer presented by VCM at a meeting of the International
Agency for Research of Cancer held in Lyon on 23-25 June 1974 .
The same problem was also debated by international experts at
the conference on cancer held in Florence in October 197 ^. At
the same time MEDICHEM added the carcinogenicity and genetic
effects of this substance to the agenda of its seminar in Milan .
Research contracts were awarded by the Ministries of Labour and
Social Affairs in the countries concerned with the aim of de­
fining the extent of the hazard and adopting more stringent
safety measures .
         Various meetings and one seminar were organized by the
departments of the Commission during 197 ^- and. 1975 .
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 ---pagebreak---                                    - III  -
               During this seminar at these meetings , the following
  areas were defined and correspond to the different health
  aspects :
                                            1 ) Production of the base
                                                product : VCM
                                                Production of its polymer : PVC
  A. Workplace
                                            2 ) Transformation of the polymeri
                                                sation products
  B. Environmental protection
  C. Consumer protection +
  D. Waste disposal
               The conclusions of these meetings and. of other work carried out
    in parallel have led the Commission to propose a directive which the
    Council has adopted on the 27th July 1976 with regard to the harmonization
    of the legislation in Member States relative to the limitation of the
    marketing and use of certain dangerous substances and preprations . (+)
                This directive represents the first Community measure aimed at
     the prohibition of the use of vinyl chloride monomer (VCM) as an aerosol
     propellent for any purpose .
               This Directive also answers the requests made by the
  European Parliament in the form of two written questions .
  It is the result of extensive discussions with independent
   experts and of two meetings with government experts ( 19 No­
   vember 1975 and 8-8 December 1975 ). Its aim is to define
   preventive measures in terms of both technology and Industrial
   hygiene which are geared to health protection at work .
   Directive 76/769/EEC , OJ L 262 of 27.9*1976 .             „ . _    , aQ . Mç.
■H- European Parliament : written questions Nos 178/75 and 68l/75
      2096 / 7 / 75 e
 ---pagebreak---                               - 1 -
The Council of the European Communities ,
- Having regard to the Treaty establishing the European Economic
    CorMiuwity , and in particular Article 100 ,
- Having regard to the Proposal from the Commission ,
- Having regard to the Opinion of the European Parliament ,
- Having regard to the Opinion of the Economic and Social Committee
Whereas in the past VCM has been recognized only as the cause of the generally
  reversible syndrome known as 'occupational acro-osteolysis * ;
    whereas      more recent evidence from epidemiological studies and
animal experimentation indicates that prolonged and/or repeated
exposure to high concentrations of VCM in the atmosphere may cause
a 'VCM' syndrome encompassing , in addition to occupational acro-
osteolysis , skin diseases such as scleroderma , and liver disorders ;
Whereas VCM should also be regarded as a carcinogen which may cause
angiosarcoma , a rare malignant tumour which can aLso occur
without any known cause ;
Whereas although present-day working conditions are considerably
better than those under which the above syndrome formerly occurred ,
        a comparison of protective measures taken by each Member
State reveals certain differences and therefore , in the interests
of developing      an economic and social balance , these national
laws , which have a direct effect on the functioning of the com­
mon market , should be harmonized and improved ;
Whereas the first action should be to take preventive and
protective measures based on the latest scientific knowledge ,
so that the internal concentrations of VCM in the atmosphere in both
 existing and future factories can be reduced to minimal values ;
2096/7/75 e
 ---pagebreak---                                                                                s
                             - 2 -
Whereas medical surveillance of workers in the VCM/PVC industry
should be carried out on the basis of the latest medical know­
ledge in order that the health of workers in this important
economic sector of the chemical industry may be protected ;
Whereas the urgency of the harmonization of laws in this field
is recognized by both sides of industry , both of which took
part in the discussion on this specific - problem ;         whereas efforts
 must therefore be made towards the upward harmonization of t-ews , regulations
 and administrative provisions as envisaged in Article 117
of the Treaty ;
Whereas it might prove necessary to revise the health protection
standards contained in this Directive ;
Whereas , to make it easier to adopt the necessary measures ,
there should be a procedure to ensure close cooperation between
the Member States and the Commission within a Committee to
amend this Directive in the light of technical progress ,
 2096/7/75 e
 ---pagebreak---                                                                           τ
                            - 5 -
HAS ADOPTED THIS DIRECTIVE :
                         Article 1
1.1 . The object of this Directive is the protection of workers
        employed in works in which
        - vinyl chloride monomer , hereinafter referred to as VCM,
          is produced , reclaimed , stored , discharged into containers ,
      |    transported or used in some other way,
        - vinyl chloride monomer is converted into unformed vinyl
           chloride polymers , hereinafter referred to as PVC ,
        who are exposed to the effects of VCM in their working
        area .
1.2 . This protection shall be ensured by the establishment of :
        - limit values for the atmospheric concentration of VCM
          in the working area ;
        - measuring and monitoring techniques necessary for this
          purpose , as well as other preventive measures ;
        - guidelines for medical surveillance .
                       Article 2
For the purposes of this Directive :
2.1 .. The 'working area 1 means a section of a works with defined
        boundaries which may comprise one or more workplaces . It
        is characterized by the fact that the individual worker
        spends irregular periods of time within it at various
         workplaces in the course of his duty or duties , that the length
        of time spent at these individual workplaces cannot be
     | more closely defined, and that further subdivision of the
        working area into smaller units cannot be made . It is assumed
        that the individual worker is normally employed in one
        working area only .
2096/7/75 e
 ---pagebreak---                                - il -
2.2 . The    technical long-term limit value 1 means the mean con­
       centration of VCM , measured over 1 year , in the atmosphere
       of a working area which may not be exceeded during exposure
       to it for 8 hours a day or 40 hours a week .
       For practical purposes , limit values for shorter reference
       periods ( i.e. 1 month, week , shift or hour ), corresponding tjo the
       technical long-term limit value , are given in Annex I.
                            Article 3
3.1 . The fundamental aim of technical monitoring shall be to
       reduce to below measurable levels the atmospheric concentrations of
       VCM to which workers are exposed . All working areas in works . referred
       to in Article 1.1. shall therefore be monitored for the presence of VCM .
3.2 . For new VCM/PVC works , a maximum atmospheric concentration
       of 5 ppm , which may not be exceeded , shall be laid down
       as the technical long-term limit value for VCM .
3.3 . For existing VCM/PVC works , a maximum atmospheric concen­
       tration of 10 ppm , which may not be exceeded , shall be laid
       down as the te clinical long-term limit value for VCM .
 3.4 • The necessary -technical measures with respect to the limiting technical
       values given under 3.2 . and 3.3 . shall not in any case result in VCM
       pollution of the environment outside the works .
                            Article 4
 The atmospheric concentration of VCM in the working area may
 be monitored by continuous and/or discontinuous methods .
 4.1 . The technical long-term limit values shall be considered
        to be complied with if the annual arithmetic mean concen­
        tration is found not to exceed this value , with a confidence
        coefficient of 95# (one-sided test ).
 2096/7/75 e
 ---pagebreak---                              - 5 -
4.2 . Any measuring system giving a reliable analysis at one-
        third at least of the technical long-term limit value
        concentration shall be regarded as suitable .
4.3 * If non-selective systems are used for measuring VCM , the
        total measurement recorded shall be taken as the VCM
        concentration value .
4.4 . Measuring instruments must be calibrated adequately at
        regular intervals .
4.5 * Pending the approval at Community level of a standard
           method    for checking VCM measuring techniques , suitable
        methods based on the latest state of the art shall be
    ij used for calibrating the measuring instruments .
                                Article 5
One or more measuring points may be set up in a working area ,
depending on its size .
5.1 . Measuring points mu^ be chosen in accordance with the particular
        characteristics of the works and so designed that the
        results indicate as accurately as possible the individual
      • VCM level of exposed persons .
        This does not necessarily mean that measurements must always
        be taken with devices worn by exposed persons . Fixed position
        instruments may also be used provided that the results ob­
        tained thereby5 are representative of the concentration throughout
        the working area .
5.2 . If a number of fixed position measuring points are provided
        in one working area , the mean of the values from all the
        points may be regarded as the measurement for the whole
        workino area .
2096/7/75 e
 ---pagebreak---                              - 6 -
5.3 . In all cases of doubt as to whether the results obtained by
       fixed position measuring instruments are represent             . ve
      of the concentration in the working area , the measuring
      point for the technical long-term limit value in the
      working area shall be that point where the risk is greatest .
      Personal dosimeters may be        used for comparative measurements
      where appropriate , the arrangement of the measuring points may be
      modified .
                            Article 6
A monitoring system which gives continuous mean values for at
least one hour shall be provided to detect abnormal increases
in concentration levels caused by technical failures in wor­
king areas in works producing VCM/PVC .
6.1 . The threshold . concentration at which the alarm is triggered
       shall depend on the measuring system and on operating con­
       ditions .
6.2 . An increase in VCM concentration shall be regarded as abnor­
       mal when     it exceeds approximately five times the mean
       weekly value . In such an event , technical                       __
       measures to discover the causes shall be taken without
       delay .
6.3 . The alarm threshold shall not , however , be greater than
       40 ppm. If this value is exceeded , technical and personal
   S   protective, measures shall be taken without delay .
                          Article 7
Appropriate personal protection shall be provided for certain
 operations ( e.g. cleaning of autoclaves , servicing and repairs ),
 during which it cannot be guaranteed that concentrations will be kept
 below the permitted limit values by means of operational or ventilation
 measures .
 2096/7/75 e
 ---pagebreak---                                                                   */5
                             - 7 -
                           Article 8
Workers shall be informed at regular intervals of the health
hazards involved and of the appropriate protective measures to be
 taken when handling VCM .
                         Article 9
A register shall be kept of workers employed on operations de­
scribed in Article 1.1.' , with particulars of the type and duration
of work , and the resulting exposure . A copy of this register
shall be given to the industrial medical officer responsible
for surveillance , unless the register is kept by the officer
himself .
                           Article 10
Workers employed in working areas referred to in Article 1.1 .
shall undergo a medical examination by a qualified industrial
medical officer on recruitment and also subsequently.
10.1 . Without prejudice to national regulations , the industrial
       medical officer shall determine the frequency and the type
       of examination to be carried out in each individual case .
       The necessary guidelines are given in Annex II .
10.2 . Medical records and the register provided for in Article 9
         shall be kept until the possibility of occupational disease
        caused by VCM exposure can be excluded .
       These records shall form the basis for further prognostic
        epidemiological surveys which prove necessary , the results
        of which shall be reported by the Member States to the
        Commission at three-yearly intervals .
2096 /7 /75 e
 ---pagebreak---                              -δ­
                                                                    ι
                         Article 11
11»1 » This Directive shall be reviewed at least every two years
        in the light of developments in technology and occupational
        medicine .
11.2 . A Committee consisting of representatives of the Member
        States , with a representative of the Commission as
        Chairman , shall be set up for this purpose .
11.3 . The Committee shall draw up its own Rules of Procedure .    *
  |                       Article 12
12.1 . Where the procedure laid down in the preceding Article,     ^
        is to be followed , the Chairman . shall refer the matter
        to the Committee , either on his own initiative or at
        the request of a representative of a Member State .
12.2 . The representative of the Commission shall submit to
        the Committee a draft of the measures to be adopted .
        The Committee shall deliver its Opinion on such measures
        within a time limit set by the Chairman . according to the
        urgency of the matter . Forty-one votes shall be required
        to constitute a majority , the votes of the Member States
        being weighted in accordance with Article 148(2 ) of the
        Treaty . The Chairman , shall not vote .
12.3 . The Commission shall adopt the measures where they are
        in accordance with the Opinion of the Committee .
12.4 . Where they are not in accordance with the Opinion of the
        Committee , or if no Opinion is delivered , the Commission
         shall forthwith propose to the Council the measures to be
    |    adopted . The Council shall act by a qualified majority.
 12.5 . If the Council has not acted within three months of the date
         of the submission o<f the proposal , the Commission shall
         adopt the proposed measures .
 ---pagebreak---                      - 9 -
                 Article 13
13.1 . Member States shall bring into force the laws , regulations
       and administrative provisions needed in order to comply
   }   with this Directive within 18 months of its notification
       and shall forthwith inform the Commission thereof .
13.2 . Member States shall communicate to the Commission the
       texts of the main provisions of national law which they
       adopt in the field covered by this Directive .
                Article 14
This Directive is addressed to the Member States .
2096/7/75 e
 ---pagebreak---                                                      ANNEX I
                      - 1 -
Statistical basis for the technical long-term limit value
1 . Owing to differences in definition the recommended values
      for the permissible concentration of hazardous substances
      in the air at the workplace currently vary from country
     to country .
    This Directive is therefore concerned with a new, statistically
     defined reference value - the technical long-term limit value ,,
     which should be regarded as a mean annual value (Article 2.2 .)*
2 . The limit values for shorter reference periods are based on
     data obtained by extensive measurement of VCM concentrations
     in the PVC industry . These results coincide with data for
     other harmful substances and for other sectors of industry .
    This information can be summarized as follows :
     a ) the concentrations distribution of harmful substances can
    |     be represented log normally.
      b ) the logarithmic variance        T ) is dependent on the mean
          time for the individual values T^and the assessment period T
          during which the individual values are obtained .
5 . This relationship can be expressed by the following equation :
                 «^cr, T > = /hog t?/D .
      Given these conditions , a mean ratio of the limit values for
      shorter reference periods to the long-term limit value can be
      established :
 2096/7 /75 e
 ---pagebreak---                                                      ANNEX I
                    - 2 -
                    Table 1
  4 . Limit values for shorter reference periods shall be regarded
      as being within the permitted limits if at least 95 $ of the
      measurement values established over a total period of one
      year are below the limit values given in Table 1 .
                                                               f
2096/7/75 e
 ---pagebreak---                                                             ANNEX II //
                           - 1 -
               Guidelines for medical surveillance
      .1
      I
1 . Current knowledge indicates that over-exposure to VCM can give
    rise to the following disorders and diseases :
          - sclerodermatous skin disorders
          - circulatory disorders in the hands and feet ( similar
             to Raynaud 's syndrome )
          - acro-osteolysis ( in the region of various bone structures
             and affecting particularly the hand phalanges )
          - liver and spleen fibroses ( similar to perilobular
             fibrosis , known as Banti 's syndrome )
          - lung function disorders
          - thrombocytopenia and
          - hepatic angiosarcoma .
2 . Medical surveillance should take account of all symptoms and
    syndromes , with particular emphasis on the area of greatest
    risk . As far as is known , no symptoms , occurring separately or
    in combination have been identified as precursors or transition­
    al stages of hepatic sarcoma . As no specific methods of preven­
    tive analysis are known for this disease , medical action must
    include at least the following measures as minimum requirements :
          l ) records of the worker 's medical and occupational history
        • 2 ) clinical examination of the extremities , the skin and
              the abdomen
          3 ) X-ray of the hand bones ( every two years ).
    Further tests , particularly laboratory tests , are desirable .
    These should be decided by the medical officer in the light of
    the most recent developments in industrial medicine .
    The following laboratory tests are suggested at present for
     prognostic epidemioxogical surveys :
           - urinalysis ( glucose , proteins , salts , bile pigments ,
             urobilinogen ) ;
           - erythrocyte sedimentation rate ;
           - blood platelet count
 2096 /7/75 e
 ---pagebreak---          - determination of total bilirubin level
         - determination of transaminase levels ( SGOT , SGPT )
         - thymol turbidity test
         - alkaline phosphatase level
         - determination of cryoglobulin .
3 . As in the case of all biological examinations , the results
    of the tests must be interpreted in the light of the labora­
    tory techniques used and their nornial results . Generally
    speaking , the significance of a functional disorder is
    revealed by Joint consideration of the results obtained with
    the various methods and by developments in tho anomalies
    observed . As a general rule , abnormal results must bo further
    investigated and , if necessary , additional specialist;
    examinations carried oub .
4L The industrial medical officer shall decide in each case
    whether a worker is suitable for a particular working area .
    The industrial medical officer shall also be competent to
    decide what con era - Lnd .L <! ations apply .
    The most important of these are :
        - typica.l vascular ana neuro vascular lesiona ,
        - lung function disorders ,
        - clinical or biological hepatic Insufficiency ,
        - diabetes ,
        - chronic renal insufficiency ,
        - thrombocytopenia and hemorrhagic disorders ,
        - certain chronic skin diseases such as . scleroderma *
        - abuse of alcohol and/or addiction to drug;>.
    This list , which Is Intended merely for guidance , has been
    drawn up using pathological data obtained from previous
    retrospective studies .
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