COMMON POSITION (EC) No 12/1999 adopted by the Council on 22 December 1998 with a view to adopting Council Directive 1999/.../EC amending for the second time Directive 90/394/EEC on the protection of workers from the risk related to exposure to carcinogens at work and extending it to mutagens
Date: 1998-12-22
Institutions: Council of the European Union
Subjects: carcinogenic substance, dangerous substance, occupational health, occupational safety, safety standard

25.2.1999

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C 55/39

COMMON  POSITION  (EC)  No  12/1999

adopted  by  the  Council  on  22  December  1998

with a view to adopting Council Directive 1999/. . ./EC amending for the second time Directive
90/394/EEC  on  the  protection  of  workers  from  the  risk  related  to  exposure  to  carcinogens  at
work  and  extending  it  to  mutagens

(1999/C 55/05)

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  (sixth
individual  Directive  within  the  meaning  of  Article  16(1)
of  Directive  89/391/EEC) (1),

(4) Whereas because of their mechanism of action germ
likely  to  have  carcinogenic

cell  mutagens  are 
effects;

(5) Whereas  vinyl  chloride  monomer  is  classified  as  a
category  1  carcinogen  under  Council  Directive
67/548/EEC of 27 June 1967 on the approximation
of  laws,  regulations  and  administrative  provisions
the  classification,  packaging  and
relating 
labelling  of  dangerous  substances (5);

to 

Having  regard  to  the  proposal  from  the  Commission (2),
submitted 
the  Advisory
Committee  on  safety,  hygiene  and  health  protection  at
work,

consultation  with 

after 

Having regard to the opinion of the Economic and Social
Committee (3),

Acting  in  accordance  with  the  procedure  referred  to  in
Article  189c  of  the  Treaty (4),

(1) Whereas  Article  118a  of  the  Treaty  provides  that
the  Council  shall  adopt,  by  means  of  Directives,
encouraging
minimum 
the  working
improvements, 
environment, 
level  of
protection  of  the  safety  and  health  of  workers;

requirements 
especially 

to  guarantee  a  better 

for 
in 

(2) 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;

(3) Whereas  germ  cell  mutagens  are  substances  that
can  cause  a  permanent  change  in  the  amount  or
structure  of  the  genetic  material  of  a  cell  resulting
in a change in the phenotypic characteristics of that
cell,  which  may  be  transferred  to  descendent
daughter cells;

the 

laws, 

(6) Whereas,  for  the  sake  of  consistency  and  clarity,
the  essential  provisions  of  Council  Directive
78/610/EEC of 29 June 1978 on the approximation
of 
regulations  and  administrative
provisions  of  the  Member  States  on  the  protection
of  the  health  of  workers  exposed  to  vinyl  chloride
monomer (6)  should  be  included  in  this  Directive,
without  reducing  the  level  of  protection  of  the
health  and  safety  of  workers;

(7) Whereas  Directive  78/610/EEC  can  be  repealed

after  implementation  of  this  Directive;

(8) Whereas the carcinogenicity of oak and beech dusts
has  been  confirmed  in  epidemiological  studies  on
workers exposed; whereas it is highly probable that
other types of hardwood dust can also cause cancer
in  humans;  whereas 
the  workers
concerned are exposed to a serious potential risk of
developing cancer;

therefore 

(9) Whereas  the  precautionary  principle  should  be
in  the  protection  of  workers’  health;
applied 
whereas  therefore  Directive  90/334/EEC  should  be
extended  to  cover  all  types  of  hardwood  dusts;

(10) Whereas  further  research  is  desirable  into  the
carcinogenicity  of  other  wood  dusts;  whereas  the
Commission  is  to  bring  forward  proposals  to
protect  the  health  of  workers  where  a  risk  is
identified;

(1) OJ  L  196,  26.7.1990,  p.  1.  Directive  as  last  amended  by

Directive  97/42/EC  (OJ  L  179,  8.7.1997,  p.  4).

(2) OJ  C  123,  22.4.1998,  p.  21.
(3) OJ  C  284,  14.9.1998,  p.  111.
(4) Opinion of the European Parliament of 22 October 1998 (OJ
C  341,  9.11.1998,  p.  132),  Council  common  position  of
22 December 1998 and Decision of the European Parliament
of  . . .  (not  yet  published  in  the  Official  Journal).

(11) Whereas Article 16 of Directive 90/394/EEC makes
provision  for  the  establishment  of  limit  values  in

(5) OJ  L  196,  16.8.1967,  p.  1.  Directive  as  last  amended  by

Directive  97/69/EC  (OJ  L  343,  13.12.1997,  p.  19).

(6) OJ  L  197,  22.7.1978,  p.  12.

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respect  of  all  those  carcinogens  for  which  that  is
possible,  on  the  basis  of  the  available  information,
including  scientific  and  technical  data;

apply  when  they  are  more  favourable  to  health  and
safety  at  work.

(12) Whereas  it  is  appropriate  to  fix  such  limit  values
for  hardwood  dusts;  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  maintaining  the  aim  of  ensuring  the
health  of  workers  at  work;

(13) Whereas  workers  must  be  effectively  protected
from  the  risks  of  developing  cancer  as  a  result  of
occupational  exposure  to  hardwood  dusts;  whereas
the aim of this Directive is not to restrict the use of
wood  either  by  replacing  it  with  other  materials  or
by  replacing  the  use  of  certain  types  of  wood  with
other  types  of  wood;

(*) OJ  L  263,  24.9.1983,  p.  25.  Directive  as  last
amended  by  Directive  98/24/EC  (OJ  L  131,
5.5.1998,  p.  11).’

2.

In  Article  2,  the  following  point  shall  be  inserted
after  (a):

‘(aa) “mutagen”  means:

(i) a  substance  which  meets  the  criteria  for
classification as a category 1 or 2 mutagen
set  out 
to  Directive
67/548/EEC;

in  Annex  VI 

(14) Whereas 

compliance  with 

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

(15) Whereas  a  consistent  level  of  protection  from  the
risks  related  to  carcinogens  has  to  be  established
for  the  Community  as  a  whole,  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;

(16) Whereas 

this
the  amendments  contained 
Directive  constitute  a  practical  aspect  of  the
realisation  of  the  social  dimension  of  the  internal
market;

in 

(ii) a  preparation  composed  of  one  or  more
substances  referred  to  in  (i)  where  the
concentration  of  one  or  more  of  the
the
individual 
requirements  for  concentration  limits  for
the  classification  of  a  preparation  as  a
category  1  or  2  mutagen  set  out  in  either:

substances 

meets 

— Annex  I  to  Directive  67/548/EEC,

or

— 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;’.

(17) Whereas,  pursuant  to  Decision  74/325/EEC (1),  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  is  hereby  amended  as  follows:

1. Article  1(4)  shall  be  replaced  by  the  following:

‘As regards asbestos, which is dealt with by Directive
83/477/EEC (*),  the  provisions  of  this  Directive  shall

(1) OJ  L  185,  9.7.1974,  p.  15.  Decision  as  last  amended  by  the

1994  Act  of  Accession.

3.

In  Article  1(1),  Article  3(1),  (2),  first  and  second
indents,  and  (4),  Article  5(5)(c),  (d),  (e)  and  (j),
Article  6(a)  and  (b),  Article  10(1),  introductory
wording,  and  point  (a),  Article  11(2),  Article  14(3),
Article  16(1) 
the  word
‘carcinogens’  shall  be  replaced  by  ‘carcinogens  or
mutagens’.

and  Article  17(2), 

4.

In  Article  2(b),  Article  4(1),  Article  5(2)  and  (5),
heading  and  point  (a),  the  word  ‘carcinogen’  shall  be
replaced  by  ‘carcinogen  or  mutagen’.

5.

In  Annex  I  the  following  section  shall  be  added:

‘5. Work  involving  exposure  to  hardwood  dusts (*).

(*) A  list  of  some  hardwoods  is  to  be  found  in
volume  62  of  the  Monographs  on  the
Evaluation of Carcinogenic Risks to Humans
“Wood  Dust  and  Formaldehyde”,  published
by  the  International  Agency  for  Research  on
Cancer,  Lyon  1995.’

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6.

In  Annex  III,  Part  A  shall  be  replaced  by  the  following:

‘A. LIMIT  VALUES  FOR  OCCUPATIONAL  EXPOSURE

Name  of
agent

No  Einecs (1)

No  CAS (2)

Limit values

mg/m3 (3)

ppm (4)

Notation

Transitional measures

Benzene

200-753-7

71-43-2

3,25 (5)

1 (5)

Skin (6)

Limit  value:  3  ppm
(=  9,75  mg/m3)  until
. . .  (three  years  after
date  in  Article  2(1)
of  Directive  97/42/
EC (*))

Vinyl
chloride
monomer

Hardwood
dusts

200-831

75-01-4

7,77 (5)

3 (5)

—

—

5,0 (5) (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).
(4) ppm = parts  per  million  by  volume  in  air  (ml/m3).
(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.
(7) Inhalable  fraction;  if  hardwood  dusts  are  mixed  with  other  wood  dusts,  the  limit  value  shall  apply  to  all  wood

dusts  present  in  that  mixture.

(*) OJ  L  179,  8.7.1997,  p.  4.’

Article  2

Directive  78/610/EEC  shall  be  repealed  with  effect  from
. . . (*).

Article  3

On  the  basis  of  the  latest  available  scientific  data,  the
Commission  may  within  two  years  of  the  date  of  the
adoption  of  this  Directive,  submit  a  proposal  to  the
Council  for  the  adoption  of  revised  limit  values  for  vinyl
chloride  monomer  and  hardwood  dusts  in  accordance
with  Article  118a  of  the  Treaty.

official  publication.  The  methods  of  making  such
reference  shall  be  laid  down  by  the  Member  States.

States 

2. Member 
the
shall 
Commission  the  text  of  the  provisions  of  domestic  law
which 
this
the 
Directive.

field  governed  by 

communicate 

they  adopt 

to 

in 

Article  5

This  Directive  shall  enter  into  force  on  the  day  of  its
publication  in  the  Official  Journal  of  the  European
Communities.

Article  4

Article  6

1. Member  States  shall  bring  into  force  the  laws,
regulations  and  administrative  provisions  necessary  to
comply  with  this  Directive  not  later  than  . . . (*).  They
shall  forthwith  inform  the  Commission  thereof.

When  Member  States  adopt  these  measures,  they  shall
contain  a  reference  to  this  Directive  or  shall  be
accompanied  by  such  reference  on  the  occasion  of  their

This  Directive  is  addressed  to  the  Member  States.

Done  at  . . .

For  the  Council

The  President

(*) Four  years  after  the  date  of  the  adoption  of  this  Directive.

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STATEMENT  OF  THE  COUNCIL’S  REASONS

I.

INTRODUCTION

1. On  19  March  1998,  the  Commission  forwarded  to  the  Council  the  abovementioned

proposal  for  a  Directive,  based  on  Article  118a  of  the  EC  Treaty.

The  European  Parliament  and  the  Economic  and  Social  Committee  delivered  their
opinions  on  22  October  1998  and  2  July  1998  respectively.

Following  the  opinion  from  the  European  Parliament,  the  Commission  submitted  an
amended  proposal  on  16  November  1998.

2. On  22  December  1998,  the  Council  adopted  its  common  position  pursuant  to

Article  189c  of  the  Treaty.

II. OBJECTIVE

The  aim  of  the  draft  Directive  is:

— to  extend  the  scope  of  Directive  90/394/EEC  to  mutagenic  substances  not  already

covered  by  that  Directive,

— to  extend  the  scope  of  Directive  90/394/EEC  to  cover  hardwood  dusts,

— to  consolidate  in  that  Directive  the  existing  Directive  78/610/EEC  relating  to  vinyl

chloride  monomer.

Exposure  limit  values  are  established  in  respect  of  the  last  two  categories  of  substances.

III. ANALYSIS  OF  THE  COMMON  POSITION

1. General  remarks

The  common  position  broadly  follows  the  Commission’s  amended  proposal;  in
particular, it takes up the principal amendment deriving from the European Parliament’s
opinion,  namely  the  extension  of  the  provisions  in  respect  of  beech  and  oak  dusts  to
hardwood  dusts  as  a  whole.

As  far  as  mutagens  are  concerned,  the  Council  considered  that,  as  it  had  not  been
proved  that  all  mutagenic  substances  were  necessarily  carcinogenic,  those  substances
should be taken up in the text in their own right and not simply included in Annex I of
Directive  90/394/EEC,  as  proposed  by  the  Commission.  For  the  same  reason,  it  was
considered  that  the  title  of  the  Directive  should  be  amended  accordingly.

2. Analysis  of  the  Articles

— Article  1

— paragraph  1:  this  paragraph 

is  unchanged  relative  to  the  Commission’s

proposal,

— paragraph  2:  this  paragraph  provides  for  a  definition  of  ‘mutagens’,

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— paragraphs  3  and  4:  these  paragraphs  extend  the  scope  of  the  Directive,  where

appropriate,  to  cover  mutagens,

— paragraph 5: in accordance with amendment 6 of the European Parliament, this

paragraph  adds  a  new  Item  5  to  Annex  I  in  respect  of  hardwoods.

In  order  to  assist  Member  States  in  the  implementation  of  the  Directive,  a
footnote is added containing a reference to the International Agency for Research
on  Cancer’s  monograph  on  ‘Wood  Dust  and  Formaldehyde’,  which  contains  a
list  of  the  most  commonly  encountered  hardwoods  and  tropical  hardwoods,

— paragraph  6:  this  paragraph,  which  corresponds  to  amendment  7  of  the
European  Parliament,  covers  the  inclusion  in  part  A  of  Annex  III  of  the  limit
values  in  respect  of  vinyl  chloride  monomer  and  hardwood  dusts.

The  annual  limit  value  for  vinyl  chloride  monomer,  which  was  included  in  the
Commission’s proposal, has been deleted as the Council considered that it could
not  be  applied  in  practice.

The  limit  value  for  hardwood  dusts  is  the  same  as  that  suggested  by  the
European  Parliament  and  it  is  also  made  clear  that  the  limit  value  should  apply
to  mixtures  of  wood  dusts.  Since  the  concept  of  the  ‘inhalable  fraction’  derives
from agreed international standards and practice, further definition in the present
text  was  considered  superfluous.

— Article  2

This  article  is  unchanged  relative  to  the  Commission’s  proposal.  Amendment  9  of
the European Parliament was not taken up as it was clear that the date for repeal of
Directive 78/610/EEC should correspond to the final date for implementation of the
present  Directive.

— Article  3

This  article  corresponds  to  the  text  to  be  found  in  the  Commission’s  amended
proposal  and  consequently  includes  the  two-year  review  period  for  the  limit  values
to  be  found  in  amendment  10  of  the  European  Parliament.

— Article  4

In  accordance  with  amendment  11  of  the  European  Parliament,  the  Commission’s
amended  proposal  provided  for  a  three-year  implementation  period.

The  Council  decided  that  this  period  should  be  extended  to  four  years,  principally
on  account  of  the  cost  implications  for  small  and  medium-sized  enterprises  of
complying  with  the  new  limit  value  in  respect  of  hardwood  dusts.

— Articles  5  and  6

Standard  provisions.

3. Preamble

The  preamble  has  been  adapted  to  reflect  changes  in  the  text  relative  to  that  of  the
Commission’s  amended  proposal.

Amendment 3 of the European Parliament is taken into account in the eighth, ninth and
tenth  recitals.

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Furthermore, the essence of amendment 5 of the European Parliament is reflected in the
eleventh,  twelfth  and  thirteenth  recitals.

4. Other  amendments  proposed  by  the  European  Parliament

Amendment  1: This  amendment  was  not  taken  up  by  the  Commission  in  its  amended
proposal.  In  any  event,  the  implementation  period  of  four  years
(Article  4)  provides  for  an  adequate  transitional  period.

Amendment  4: This  amendment  was  not  taken  up  by  the  Commission  in  its  amended

proposal.

IV. CONCLUSION

The Council considers that the text of the common position fulfils the essential aims of the
Commission’s  proposal,  notwithstanding  certain  relatively  minor  divergences  from  the  text
of  the  amended  proposal.