Proposal for a Council Directive amending for the second time Directive 90/394/EEC on the protection of workers from the risks related to exposure to carcinogens at work
Date: 1998-03-18
Institutions: European Commission
Subjects: cancer, carcinogenic substance, health control, health risk, occupational safety

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 18.03.1998 
COM(1998) 170  final 

98/0093 (SYN) 

Proposal for a 

COUNCIL DIRECTIVE 

amending for the second time Directive 90/394/EEC 
on the protection of workers from the 
risks related to exposure to carcinogens at work 

(presented by the Commission) 

Proposal for a Council  Directive 
amending for the second time Directive  90/394/EEC 
on the protection of workers from the 
risks related to exposure to carcinogens at work 

(98/. 

) 

(Text with EEA  relevance) 

EXPLANATORY  MEMORANDUM 

1. 

Introduction 

a)  Reason for Community  action 

When  adopting  its  common  position  3/97/EC1  with  a  view  to  adopting  the 
Council  Directive  amending  for  the  first  time  Directive  90/394/EEC2  on  the 
protection  of  workers  from  the  risks  related  to  exposure  to  carcinogens  at 
work  (which  was adopted  as Council  Directive  97/42/EC3  on  27 June  1997), 
the Council invited the Commission to  submit  a proposal  to further  amend the 
existing Directive 90/394/EEC. 

This was in order to: 

• 

• 

provide appropriate  standards against the risk from  mutagenic  substances 
not  already  covered  by  that  Directive,  but  which  were  likely  to  show 
carcinogenic  effects, 

bring  forward  measures  addressing  the  question  of  carcinogenicity  of 
wood  dusts  with  a view to  their  inclusion  in that  Directive  and  to  clarify 
how  the  provisions  of  Directive  90/394/EEC  could  be  applied  to  wood 
dusts, 

• 

consolidate  in that  Directive the existing Directives  on carcinogens  at the 
workplace, in particular vinyl chloride monomer and asbestos. 

O J N 0 C 6,  9.1.1997, p. 1 
OJ No L  196, 26.7.1990, p. 1 
OJNoL  179, 8.7.1997,  p. 4 

The  purpose  of  this  proposal  for  the  second  amendment  to  Directive 
90/394/EEC is to reply to this request from the Council. 

b) 

Subsidiarity 

The proposal  does not breach the principle of subsidiarity, because it is only by 
Community  action  that  a  minimum  level  of  protection  for  workers  from  the 
risks related  to  exposure  to  carcinogens  can be assured  in  all  member  States. 
This  action  will  also  avoid  any  distortion  in  the  area  of  competitiveness  by 
preventing  the  unequal  application  of  minimum  standards  for  worker 
protection in one or other Member States. 

Moreover  this  proposal  will  encourage  more  flexibility  in  cross  border 
employment  because  workers  can be  reassured  that  they  will  find  at  least  the 
minimum  level  of  protection  of  their  health  and  safety  in  all  Member  States. 
Employers  will  also  be  reassured  that  the  costs  of  production  will  not  be 
unduly  distorted  as a result  of differences  in the  levels  of protection  of  health 
and safety  at work. 

2.  Mutagens 

Most  mutagens,  because  of  the  nature  of  their  interaction  with  DNA  can  be 
expected  to be carcinogenic. This strong presumption  of carcinogenicity  has led  the 
Scientific  Committee  for  Occupational  Exposure  Limits  to  Chemical  Agents 
established  by  Commission  Decision  95/320/EC(4) 
that  for  risk 
management purposes at workplace it is appropriate to treat  germ cell mutagens and 
genotoxic  carcinogens  in  a  similar  manner,  because  of  the  seriousness  of  their 
effects,  the uncertainty  about  their dose-response  characteristics  and  the  inability  to 
reliably identify  a dose threshold for their actions. 

to  advise 

-  In  scientific  terms  a  mutagenic  substance  is  defined  as  one  that  can  alter  the 

information  content of DNA in exposed organisms. 

A mutation  is  a  change  in  the  information  content  of  DNA  in  a  cell.  When  the 
mutation is in a germ cell then there is a risk that the mutation  can be transmitted 
to  future  generations.  If the  mutation  affects  a  somatic  cell,  then  there  is  a risk 
that the individual may develop cancer. 

OJNoL  188, 9.8.1995, p. 14 

At  Community  level  mutagens  are classified  according  to  the  Council  Directive 
67/548/EEC  on  the  approximation  of  the  laws,  regulations  and  administrative 
provisions  relating  to  the  classification,  packaging  and  labelling  of  dangerous 
substances5  into  three  categories.  Only  categories  1 and  2  are  relevant  for  the 
present  amendment;  these  are  labelled  with  the  risk  phrase  R46-May  cause 
heritable genetic damage. 

Category  1 

Substances known to be mutagenic to man. 
There  is  sufficient  evidence  to  establish  a  causal  association  between  human 
exposure to substance and heritable damage. 

Category 2 

Substances which should be regarded as if they are mutagenic to man. 
There is sufficient  evidence to provide a strong presumption that human exposure 
to  the  substance  may  result  in  the  development  of  a  heritable  genetic  damage, 
generally on the basis of: 
- appropriate animal studies, 
- other relevant information. 

Most  chemical  germ cell  mutagens  act via the alkylation of DNA  in germ cells. 
The  difference  in  comparison  to  the  DNA-damaging  action  of  genotoxic 
carcinogens  is  mainly  the  different  target  cell/tissue.  For  chemical  germ  cell 
mutagens following this mechanism there is no commonly accepted safe threshold 
and furthermore, for substances which cause heritable genetic damage there is no 
commonly agreed model for a quantitative risk assessment. 

For all these reasons there is a general consensus that as a precaution this type of 
mutagen should be treated as carcinogens for the purpose of the Directive. 

Therefore  Article  1.1  as  well  as  Annex  I  of  Directive  90/394/EEC  should  be 
amended accordingly. 

OJNoL196,  16.8.1967, p. 1 

3.  Wood dusts 

Following  the  request  from  the  Council,  the  Commission  requested  the  Scientific 
Committee  on  Occupational  Exposure  Limits to  advise  whether  all  wood  dusts,  or 
dusts of specific types of wood, should be considered  as carcinogenic to human. The 
committee  was  also  asked  to  advice  on  an  a  proposal  for  occupational  exposure 
limits for wood dusts, taking into account all possible health  effects. 

The  committee  unanimously  agreed  that  there  is  conclusive  evidence  that  dusts  of 
oak  and  beech  are  carcinogenic  to  humans,  particularly  with  respect  to  nasal 
adenocarcinomas. The evidence for other types of wood is less compelling. 

The  committee  has  not  yet  been  able  to  provide  a  detailed  risk  assessment  which 
could  allow  the  Commission  to  propose  a  scientifically  based  figure  which  would 
reflect the lowest acceptable risk. 

The committee based its opinion on the following elements: 

-  The  IARC  Monograph  on  wood  dust  (Vol.  62.  1995)  concluded  that 
occupational  exposure  to  wood  dust  is  causally  related  to  adenocarcinoma  of 
the nasal cavities and paranasal  sinuses. The excess appears to be attributable to 
wood  dust  per  se,  rather  than  to  other  exposure  in  the  workplace.  The 
adenocarcinoma  increased  risk  is  clearly  associated  with  the  exposure  to 
hardwood  dust but occupational  exposure to a single type of wood  is rare, with 
most  occupations  involving  exposure  to  many  species.  No  sufficient  studies 
exist to evaluate cancer risks attributable to exposure to softwood  alone. 

-  More recent publications confirming this primary hypothesis. 

-  The definition  of woods as hard and soft  is not universally agreed.  According to 
IARC (1995), there are about  12000 species of wood,  of which the majority  are 
deciduous or hardwood,  and only about 800 are coniferous  or  softwood. 

-  There  are  no  recognised  biological  or  physical  differences  between  hardwood 
dusts  and  softwood  dusts.  Dust  size  is  determined  by  the  moisture  content  of 
the wood  and the process in which the dust  is generated,  not  by the  species  of 
wood. 

-  It was noted that in many types of working environment,  possible contamination 
of softwood  dust by hardwood dust cannot be excluded.  Also, exposure occurs 
not just  to  dusts  from  mixtures  of  woods,  but  also  to  many  chemical  agents, 
such as additives, adhesives,  stains, etc. Wood dust could be a carrier for these 
other agents. The nature of the concomitant exposures varies but the wood dust 
is  a  common  link  in  the  positive  epidemiological  studies.  Experiments  in 
progress at the German Institute for Cancer Research might  help to  clarify this 
issue. 

-  Extracts of hardwood dust, but not softwood  dust, are reported to be genotoxic, 
but  the  committee  recognised  the  limitations  of  results  of  studies  involving 
fractionation and extraction of complex materials. 

The  Committee  therefore  concludes  that the  carcinogenicity  of  dusts  of beech and 
oak  has  been  confirmed.  That  the  dusts  of  other  hardwoods  likewise  have  a 
carcinogenic  potential  in  humans  is  probable but  not  conclusively  proven  There  is 
evidence, although limited, that softwood  dusts may also be carcinogenic to humans. 

For  all  these  reasons  the  Commission  concludes  that  the  provisions  of  Directive 
90/394/EEC as modified  ought to  apply to  dusts of beech and oak,  and may in the 
future  also  apply to  other types  of wood  when further  scientific  evaluation  of new 
data has taken place. 

For  clarity,  therefore  Annex  I of  Directive  90/394/EEC  shall  be  amended  with an 
item covering occupational exposure to dusts of beech and oak. 

The Commission  recognizes  that  it  cannot  on the basis  of  current  scientific  advice 
set a scientifically based occupational exposure limit which could provide a validated 
level  of  protection.  Nevertheless  it  believes  that  modern  technological  practices 
should be applied. On the basis of current advice from Member States experts levels 
have been fixed nationally which vary between  2  and  10 mg/m3,  depending  on the 
nature of the national corresponding controls. 

The  Commission  believes  that  5  mg/m3  is  an  appropriate  indication  of  minimum 
standards  for  good  technological  practice  level  but  this  figure  should  be  reviewed 
within five years in order to align it with the most recent scientific data on health and 
safety of workers. 

4.  Consolidation  into  Directive  90/394/EEC  of  existing  Council  Directives  on 

protection  of workers against specific  carcinogens 

The adoption by the Council of Directive 90/394/EEC  on the protection  of workers 
from  the  risks  related  to  carcinogens  at  work  was  a  major  step  forward  in  the 
improvement  of protection of the health and safety  of workers against  carcinogenic 
agents. However it has become clear that the legislation should be further  simplified. 
The question was raised as to the opportunity of including the provisions of Council 
Directives on vinyl chloride monomer6 and on asbestos7 into Directive 90/394/EEC. 

Taking  into  account  the  general  principles  of  protection  provided  for  in  this 
Directive,  and  following  an  in-depth  analysis  of  the  Directive  78/610/EEC,  it  has 
been  concluded  that  the  important  provision  of  Directive  78/610/EEC,  with  the 
exception  of  the  limit  value,  are  already  subsumed  in  Directive  90/394/EEC. 
Therefore the Commission proposes that limit values shall be added to the Annex III 
of Directive 90/394/EEC and that Directive 78/610/EEC shall be repealed. 

Nevertheless,  it was considered  appropriate,  due to the long period passed from the 
adoption  of Directive  78/610/EEC,  to  propose  revised  lower  limit  values  based  on 
best  technological  practice  reported  from  recent  available  literature  and  the  legal 
situation  in Member  States.  However  a review  of  these  values  is  proposed  within 
five years on the basis of available scientific  data relating to the safety  and health of 
workers to determine whether further reduction are required. 

As far as the Directive on asbestos is concerned the situation is somewhat  different 
owing  to  the  specificity  of  this  agent  and  prohibitions  and  specific  detailed 
provisions  contained  in  Directive  83/477/EEC  which  has  been  considered  to  be 
supplemented by Directive 90/394/EEC. 

Furthermore  the  Commission  has  recently  adopted  a  Communication  on  the 
provisions  of  Directive  83/477/EEC8  and  reactions  are  awaited  from  Council  and 
European  Parliament  in  order  to  evaluate  either  which  existing  measures  shall  be 
amended or which are new provisions to be included. 

For the  above  reasons,  it  has been  considered  more  appropriate  to  delay  decision 
relating  to  the  inclusion  of  the  provisions  related  to  occupational  exposure  to 
asbestos in the framework of this Directive. 

OJNoL197, 22.7.1978, p.  12 
OJ No L 206, 29.7.1991, p.  16 
COM(96) 426 final, 5.9.1996 

Proposal for a Council Directive 
amending for the second time Directive 90/394/EEC 
on the protection of workers from the 
risks related to exposure to carcinogens at work 

(98/. 

) 

(Text with EEA  relevance) 

(Submitted  by the Commission on 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European  Community,  and in particular Article 
118a thereof, 

Having  regard  to  Council  Directive  90/394/EEC  of  28  June  1990  on  the  protection  of 
workers from the risks related to  exposure to  carcinogens  at work^  ,  as amended  for  the 
first  time by Directive 97/42/EC(10), 

Having  regard  to  the  proposal from the  Commission(n),  drawn  up  following  consultation 
with the Advisory Committee on Safety, Hygiene and Health Protection at Work, 

Having regard to the opinion of the Economic and Social Committee(12), 

Acting in accordance with the procedure referred  to in Article  189c of the Treaty(13), 

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; 

9 
10 

OJL 196, 26.7.1990, p.  1 
OJL 179, 8.7.1997, p. 4 

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 germ cell mutagens are substances which can cause a permanent  change in the 
amount  or structure of the genetic  material  of a germ cell,  which  may in turn lead  to a 
change  in the  phenotypic  characteristics  of  that  cell,  and  which  may  be  transmitted  to 
future generations of offspring. 

Whereas because  of their  interaction  with  DNA  germ  cell  mutagens  are  likely  to  have 
carcinogenic effects; 

Whereas vinyl  chloride monomer is classified  as a category  1 carcinogen under Council 
Directive 67/548/EEC; 

Whereas,  for  the  sake  of  consistency  and  clarity,  the  essential  provisions  of  Council 
Directive  78/610/EEC on the approximation  of the laws,  regulations  and  administrative 
provisions  of  the  Member  States  on  the  protection  of  health  and  safety  of  workers 
exposed  to  vinyl  chloride  monomer  should  be  included  in  this  Directive,  without 
reducing the level of protection of the health and safety of workers; 

Whereas Council Directive 78/610/EEC can be repealed after the entry into force of this 
Directive; 

in 
Whereas  the  carcinogenicity  of  oak  and  beech  dusts  has  been  confirmed 
epidemiological  studies  on  workers  exposed;  whereas,  a  large  number  of  workers  are 
exposed to a potential health risk; 

Whereas Article  16  of  Directive  90/394/EEC  makes  provision  for  the  establishment  of 
exposure limit values in respect of all carcinogens for which this is possible,  on the basis 
of the available information, including scientific and technical data; 

Whereas it is appropriate to fix such limit values for wood dust; whereas the current limit 
values for vinyl chloride monomer should be reduced to reflect  best minimum standards 
for  technological  practices  which  reflect  feasibility  factors  while  maintain  the  aim  of 
ensuring the health of workers at work; 

Whereas the respect of the minimum requirements on the protection of health and safety  of 
workers from the specific risks related to carcinogens aims not only to ensure the protection 
of the health and safety  of each individual worker but also to  provide a level  of minimum 
protection of all workers in the Community; 

Whereas  a consistent  level  of  protection from the risks related  to  carcinogens  has  to  be 
established for the Community as a whole and whereas that level of protection has to be set 
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/EEC(14), 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, 

HAS ADOPTED THIS DIRECTIVE: 

Article 1 

Directive  90/394/EEC,  as  amended  for  the  first  time  by  Directive  97/42/EC,  is  hereby 
amended as follows: 

Article  1.4  shall be replaced by the following: 

"As regards asbestos, which is dealt with by a specific Directive, the provisions of 
this Directive shall apply when they are more favourable  to safety  and health at 
work". 

Items 5 to 7 shall be added to Annex I 

"5.  Work involving exposure to wood dusts from  the following  species: beech 

and oak. 

6.  A substance which meets the criteria for classification  as a category  1  or 2 

mutagen  set out in Annex VI to Directive 67/548/EEC; 

7.  A preparation  composed  of one or more substances referred  to in point  (6) 
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 mutagen set out either: 

M 

OJ No L 185, 9.7.1974, p. 15. Decision as last amended as a result of the 1994 Acto of 
Accession 

10 

in Annex I to Directive  67/548/EEC,  or 

in Annex I to Directive  88/379/EEC where the  substance  or  substances 
do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it 
without  concentration limits;" 

3. 

In part A of Annex  III the following  agent  shall be added: 

Name of agent  EINECSO  CAS(2) 

Vinyl chloride 
monomer 

200-831 

75-01 -4 

Wood (oak and beech) dust 

Limit values 

mg/m3 0 

ppm(4) 

Notation 

Derogations 

— 

— 

3(5) 
1  5(6) 

7.77(5) 
3.88(6) 

5.0(7) 

(1)  EINECS: European Inventory of Existing Chemical Substances 
(2)  CAS: Chemical Abstract Service Number 
(3)  mg/m3 = milligrams per cubic metre of air at 20°C and  101,3 KPa (760 mm 

mercury pressure) 
ppm = parts per million by volume in air (ml/m3). 

(4) 
(5)  Measured or calculated in relation to a reference period of eight hours. 
(6)  Overriding annual exposure limit measured or calculated as average value for 

one year. 

(7)  Wood dust as total dust; it refers to that portion of dust that can possibly be 

inhaled. It is collected by a sampling device operating at an air intake velocity of 
1.25 m/s+ 10% 

Article  2 

Directive  78/610/EEC on the approximation  of the laws, regulations and  administrative 
provisions on the protection of health of workers exposed to vinyl chloride  monomer 
shall be repealed with effect  from  .... 

Article 3 

On the basis  of the latest  available  scientific  data,  the  Commission  may within  five  years 
of the date of this Directive  present  a proposal  to the Council  for the  adoption  of  revised 
limit  values  for  vinyl  chloride  monomer  and  wood  (oak  and  beech)  dust  in  accordance 
with Article  118A of the Treaty. 

11 

Article 4 

1.  Member  States shall bring into force the laws, regulations and  administrative  provisions 
They  shall  forthwith 

necessary  to  comply  with  this Directive  not  later  than 
inform the Commission thereof. 

When  Member  States  adopt  these  provisions,  they  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 

Article 5 

This Directive is addressed to the Member States. 

Done at 

For the Council 
The President 

12 

IMPACT ASSESSMENT FORM 

THE IMPACT OF THE PROPOSAL ON BUSINESS 
with special reference to small and medium sized 
enterprises (SMEs) 

Title of proposal  :  Proposal  for  a  Council  Directive  amending  for  the  second  time 
Directive  90/394/EEC  on  the  protection  of  workers  from  the  risks 
related to exposure to carcinogens at work 

Document reference  number : 98002 

The proposal 

1.  Taking account  of  the principle  of  subsidiarity,  why  is  Community legislation 

necessary in this area and what are its main aims ? 

A Council Directive on carcinogens has existed since 1990 (90/394/EEC) 

During  discussion  at  the  Council  on the first  amendment  of  Directive  90/394/EEC, 
the  Commission  was  called  upon  to  submit  a  proposal  to  further  amend  that 
Directive in order 

to  consolidate  in that  Directive  the  existing  Directives  on  specific  carcinogens 
(i.e. vinyl chloride monomer and asbestos). 

to deal with specific matters such as mutagens and wood dusts, 

It is to cater with these requests that the Commission  is now  submitting this text  to 
the Council. 
It is also envisaged  that the texts of the Directive and its amendments will be issued 
in  due  course  in  codified  form  to  assist  employers  (SMEs)  in  identifying  the 
requirements in a clear simple way to avoid cumulation of costs. 

For reasons outlined  in the explanatory  memorandum  no change will be made at the 
moment to the asbestos Directive. 

13 

The principle of  subsidiarity  is complied  with  as indicated  in the  introduction  to  the 
explanatory  memorandum,  it is only by Community  action  that  a minimum  standard 
level of protection  of workers from  the risks related  to  exposure to  carcinogens can 
be assured  in all Member States. 

The impact on business 

2.  w/io will be affected by the proposal  ? 

which sectors of business 

The term "mutagen"  means a substances  which  is able to  produce  an  effect  on 
cell  which  is called  "mutation".  Up to  now  most  of the  mutagens  are  chemical 
agents.  It  is  impossible  define  up  which  industries  may  be  concerned  by  this 
amendment  to  Directive  90/394/EEC,  but  they  are  concentrated  on  producers 
and users of chemicals. 

As far  as wood  dust (limited to oak and beech) is concerned,  workers in a wide 
variety  of industries may be exposed.  The main woodworking  processes can be 
found  in the sawmill, furniture  and construction  industries. 

The  existing  Directive  on  vinyl  chloride  monomer  concerns  about  15  major 
chemical plants in the UE. 

size of business 

For mutagens and vinyl chloride monomer see above. 

Concerning wood  dust,  information  from  industry  indicates the existence in the 
EU  of  about  42.000 firms, to  which  has  to  be  added  an  unknown  number  of 
SMEs employing less than  20 workers.  It was  roughly  considered  that  about  2 
million  of  workers  are  employed  in  this  sector.  Because  this  proposal  for 
amendment  of  Directive  makes  reference  only  to  two  kind  of  woods  (oak  and 
beech), it may be appropriate to consider  1/3 of the above figures. 

particular geographical  areas 

No specific geographical  distribution  does exist for  mutagens and vinyl  chloride 
monomer. 
Countries  other  than  the  Scandinavian  countries  are  mainly  concerned  by  the 
kinds of wood  considered. 

14 

3.  What will business have to do to comply with the proposal  ? 

Almost  100 %of substances which have been tested as mutagens have also been 
shown to be carcinogens; up to  now  all but one of the  substances  classified  as 
mutagen in Annex I of Directive  67/548/EEC,  are also  classified  as category  2 
carcinogens. 
For  these  reason  users  of  mutagens  already  treat  them  as  carcinogens  by 
applying  the  general  provision  in  Directive  89/391/EEC  and  on  chemicals  in 
Directive 80/1107/EEC in a excessively strict way. 
Therefore  the  régularisation  of  this  situation  by  modifying  the  scope  of 
carcinogen Directive will not add supplementary costs to the user industry. 
The  inclusion  of  mutagens  in  Directive  90/394/EEC  would  mean  in  practice 
cost  saving  to  chemical  producers  industries  because  for  evaluation  purposes 
mutagenesis tests for substances are far less expensive then carcinogenesis tests. 
This view is widely supported by representatives of employers in the context for 
the Advisory Committee for Safety, Hygiene and Health Protection at work. 

Wood  dust  is  not  classified  as  carcinogen  in  accordance  with  Directives 
67/548/EEC  and  88/379/EEC.  However  Annex  I  of  Directive  90/394/EEC 
contains  a  list  of  substances,  preparation  and  processes  which,  although  not 
classified  according  to  the above  Directives  on  classification,  meet  the  criteria 
for carcinogen. Wood dust falls into this category. 
In practice Member States already apply the preventative measures of Directive 
90/394/EEC to  some kinds of wood  dusts (from  oak  and beech  namely) which 
are already considered  by relevant  Agencies  (like the  International  Agency  for 
Research  on  Cancer -  IARC) and by  some  Member  States  as  carcinogenic  to 
humans, because of sufficient  evidence of carcinogenicity. 
The  inclusion  of  work  exposing  to  involving  wood  (oak  and  beech)  dusts  in 
Annex I of the Directive 90/394/EEC and the fixing of a limit value in Annex III 
is therefore appropriate. 
Some  indication  from  the  wood  industries  estimates  costs  for  enterprises  of 
complying with a limit values of 5 mg/m3 as of the order of an average of 7000 
ECU,  for  each  workplace,  varying  from  3600  to  9000  according  to  the 
measures needed.  There are no reliable estimates of actual  costs to  industry  of 
application  of  other  provisions  in  the  Directive,  such  as  demarcation  of risk 
areas,  safe  storage  and collection,  etc.  These  must  not  be  underestimated,  but 
should not pose excessive costs if considered in pragmatic light. 
Comparison with existing national legislation demonstrates that the Commission 
proposal is a minimum which is less stringent then legislation in several Member 
States.  The aim of the current text  is to  set  a minimum  to  be  respected  by all 
Member  States,  although  it  may  be  supposed  that  as  further  scientific  data 
reinforce the conclusion on carcinogenicity  of other wood  dusts,  progressively, 
taking due account of the nature of the industry, further restrictions will need to 
be introduced in subsequent amendments which could be more expensive. 

15 

The protection  of workers against  cancer  must be considered  as a target to be 
achieved. However the nature of the woodworking industry as a "craft" industry 
must  not  be  underestimated  when  introducing  relevant  legislative  provisions. 
Clear  definition  of  the  processes  to  be  covered  now  and  later  must  be 
adequately provided for in the text to avoid unnecessary bureaucracy and costs 

Concerning  vinyl  chloride  monomer,  the  reduction  of  the  limit  values  and the 
simplification  of  their  expression  have  been  made  merely  to  cater  for  existing 
current  technological  practices  and  situation  in  the  Member  States,  and  will 
have insignificant  consequences to industry. The revocation of the Directive will 
simplify  application  of  provisions,  which  have  been  up  to  now  included  in 
several Directives. 

What economic effects is the proposal  likely to have ? 

- employment 

The advantages of improved working conditions will result in a lowering of the 
number  of  cases  of  cancer,  as  has  also  been  stressed  (and  evaluated)  by  the 
committee of scientific experts. 

These benefits will be felt not only by individual  workers as members of society 
but  also  by  the  companies  themselves,  for  which  the  cost  advantages  will  be 
expressed as: 

fewer absences through illness 
lower retraining costs, and, 
fewer cases of persons having to be pensioned off because of invalidity. 

Thus the employability  of the workforce  and its flexibility of  operation  will he 
enhanced. 

investment 

Two  types  of  additional  expenditure  will  have  to  be  incurred,  the  first 
concerning  the  measuring  of  the  limit  value  for  exposure  and,  the  second, 
arising from modifications  on the older plant and equipment to the  systems for 
preventing the release of substances into the ambient air. 

The costs as regards the first provision may obviously be comparatively low as 
there  is  no  absolute  need  for  companies  to  have  their  own  measuring 
instruments.  The  second  aspect  will  undoubtedly  weigh  more  heavily, 
particularly  in the  older  installations,  although the  actual  scale  of  intervention 
can  be  limited  in  this  case,  too,  to  those  work  stations  where  the  worker 
actually carries out his tasks. 

16 

As far  as vinyl chloride is concerned  industry  already  is in  compliance  with  the 
new provisions and will benefit  from  the simplification  of the text. 

Nevertheless,  as these arrangements  are designed  to  protect  the worker  against 
the risks of the onset of cancer, the benefits  should not be under  estimated. 

competitive position of business 

Industry  has requested  the inclusion  of mutagens  in the text  to  avoid  distortion 
to  competition  between  manufacturers  and  to  reduce  (indirectly)  the  costs  of 
testing for the evidence of carcinogenicity. 

The case of wood dust is more complicated. 
As comparable  rules  exist  in many  countries  the  modern  wood  industry  is  in  a 
position to comply. 
Smaller,  or  older types of manufacturers  may have to  introduce  new  extraction 
equipment or other forms of protection. 
Some  consultation  have  pointed  out  the  possibilities  of  competition  between 
hard woods (other than oak and beech) or between  hard or soft  woods. There is 
undoubtedly  scope  for  temporary  differences  but  the  proposal  in  designed  to 
align  the  differences  on  the  basis  of  new  scientific  data  within  5  years.  The 
disadvantages  for  individual firm in the  intervening  period  have  to  be  balanced 
against  the  advantages  to  society  as  a  whole  where  costs  of  ill  health  will  be 
reduced  and productivity enhanced. 

5.  Does  the proposal  contain measures to  lake account  of  the  specific  situation  of 

small and medium sized firms  (reduced or different requirements etc) ? 

The proposal  does not contain any specific  requirements for  SMEs in order to  avoid 
discrimination on health and safety matters among workers. 

Consultation 

6.  List of the organisations which have been consulted about the proposal  and outline 

of their main views. 

As  described  in  the  text,  the  Commission  consulted  the  Scientific  Committee  for 
Occupational  Exposure  Limits  concerning  scientific  aspects  of  its  proposal  and  the 
text is in conformity with the advice of the Committee. 

Consultations with governments, workers and employers have taken  place bilaterally 
and  officially  within the framework  of the tripartite  Advisory  Committee  for  Safety, 
Hygiene and Health Protection at work. 

The  Advisory  Committee  unanimously  accepted  the  approach 
Commission with respect to mutagens, vinyl chloride monomer and asbestos. 

taken  by  the 

17 

A majority also accepted the approach on wood dust. 
Workers agreed with the limitation to oak and beech dust, but would have preferred 
to include other types of wood in the Directive. 

Employers  did  not  contest  the  carcinogenicity  of  wood  dusts  (oak  and beech) but 
were  concerned  that  some  of  the  consequences  of  treating  these  dusts  as  a 
carcinogen  and thus  subject  to  the  Directive  90/394/EEC  would  be  unpractical  if 
rigidly  enforced. 

The  Commission  considers  that  in  any  event  the  employer  is  already  responsible 
under the "Framework" Directive 89/3 91/EEC to adequately protect workers and in 
this  sense  the  inclusion  in  Directive  90/394/EEC  helps  to  identify  the  kind  of 
provisions which integrate the general obligations (e.g.  risk assessment,  replacement 
of  the  dangerous  substance  by  the  less  dangerous,  etc).  Many  Member  States 
already  apply  specific  provisions  on  wood  dust  as  or  more  rigorous  than  the 
Commission text. 

Employers  were  also  concerned  that  training  efforts  could  be  prejudiced.  The 
Commission  believes  that  protection  of  young  people  against  carcinogenic  agents 
which may affect workers' health in late life should take precedence. 

Concerns  were  also  expressed  by  employers  that  the  application  of  Directive 
90/394/EEC to wood dust from oak and beech would  lead to the disappearance  of 
oak and beech products. The Commission stressed that oak and beech,  as such, are 
not  the  cause  of  nasal  cancer; it  is the  dust  which  is  implicated  and thus avoiding 
exposure to the dust will protect workers. 

Furthermore, the scientific  advice is such that it is possible that in the future,  if new 
data become available, a general solution for all woods will be required. 

It has also been put to the Commission that its proposal to fix a technical  guidance 
limit  value  will  make  easier  the  practical  application  of  the  above  mentioned 
provisions by employers, in anticipation of the five years scientific review. 

Government  representatives  in  the  Committee  and  in  specialised  expert  groups 
convened to address practical and technical  issues raised in particular by employers, 
could  accept  the  Commission  proposal,  but  some  Member  States  would  have 
preferred further restrictions on other hard woods, and in some cases, soft woods. 

Member States experts believed that the practical issues raised by employers could 
be addressed without changing the principles enshrined in the Directive. 

/1% 

ISSN 0254-1475 

COM(98)  170 final 

DOCUMENTS 

EN 

04  05  15 

Catalogue  number  :  CB-CO-98-169-EN-C 

ISBN  92-78-32121-4 

Office  for  Official  Publications  of  the  Ruropcan  Communities 

L-2985  Luxembourg