Amended proposal for a Directive of the European Parliament and of the Council on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (presented by the Commission in accordance with Article 250(2) of the EC Treaty) (Codified version)
Date: 2003-03-20
Institutions: European Commission
Subjects: carcinogenic substance, codification of EU law, occupational health, occupational safety

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 20.03.2003
COM(2003) 127 final

1999/0085 (COD)

Amended proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the protection of workers from the risks related to exposure to carcinogens or
mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of
Council Directive 89/391/EEC)

(presented by the Commission in accordance with Article 250(2) of the EC Treaty)

(Codified version)

1.

2.

3.

3.1.

3.2.

3.3.

3.4.

3.5.

3.6.

1

2

3

EXPLANATORY MEMORANDUM

On  8  April  1999,  the  Commission  presented  a  proposal  for  a  Council  Directive
codifying  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.

In its opinion of 11 May 1999 the Consultative Working Party of the legal services
set up under the Interinstitutional Agreement of 20 December 1994 on an accelerated
working method for official codification of legislative texts2 has stated that the above
proposal  does  indeed  confine  itself  to  straightforward  codification,  without  any
substantive changes to the acts covered by it.

In view of the work already carried out in the Council on the proposal referred to at
point 1, the Commission has decided to present - in accordance with Article 250(2)
of the EC treaty - an amended proposal for codification of the Directive in question.

This  amended  proposal  also  takes  account  of  the  purely  formal  or  editorial
amendments proposed by the Consultative Working Party of Legal Services, where
these are considered justified3.

The changes made in this amended proposal, compared with the initial proposal, are
the following:

In the title of the Directive (which becomes a “DIRECTIVE OF THE EUROPEAN
PARLIAMENT  AND  OF THE  COUNCIL”),  the  words  ‘or  mutagens’  are  inserted
after  the  word  ‘carcinogens’  and  the  word  “Council”  is  inserted  before  the  words
“Directive 89/391/EEC”.

The  reference  to  the  name  of  the  author  is  replaced  by  “THE  EUROPEAN
PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION”.

In the first citation, ‘Article 118A’ is replaced by ‘Article 137(2)’.

After  the  third  citation,  a  the  following  new  fourth  citation  is  inserted:  “Having
regard to the opinion of the Committee of the Regions2”; the corresponding footnote
is inserted: ‘OJ C […], […], p. […]’.

The  last  part  of  the  former  fourth  citation  becomes  “procedure  laid  down  in
Article 251 of the Treaty3” and the following footnote is inserted: ‘OJ C […], […], p.
[…]’.

Former footnote no. 3 becomes footnote no. 4 and the following phrase is added to
the  text  of  the  footnote:  ‘Directive  as  last  amended  by  Directive  1999/38/EC
(OJ L 138, 1.6.1999, p.66)’.

COM(1999) 152 final of 8.4.1999.
OJ C 102, 4.4.1996, p. 2.
See the opinion of the Consultative Working Party of 11.5.1999 transmitted to the European Parliament,
the Council and the Commission on 21.6.1999.

2

                                                
3.7.

In  recital  (1)  the  words  ‘several  times’  are  added  after  ‘has  been  substantially
amended5’, and the following footnote is inserted: ‘See Annex IV, Part A’; the words
“by  Directive  97/42/EC”  and  former  footnote  no.  4  are  deleted.  In  the  following
sentence, the word “therefore” is deleted.

3.8.

In former recitals (2), (4) and (7), the words ‘or mutagens’ are inserted after the word
‘carcinogens’.

3.9.

Does not concern the English version.

3.10.

3.11.

3.12.

3.13.

3.14.

The  following  new  recitals  (5)  and  (6)  are  inserted:  ‘(5)  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; (6) Because of their
mechanism of action, germ cell mutagens are likely to have carcinogenic effects’.

Former  recital  (5)  becomes  recital  (7)  and  the  following  phrase  is  added  to  the
corresponding footnote: ‘Directive as last amended by Directive 1999/33/EC of  the
European Parliament and of the Council (OJ L 199, 30.7.1999, p. 57)’.

Former recital (6) becomes recital (8) and the words ‘Council Directive 88/379/EEC
of  7  June  1988’  are  replaced  by  the  words  ‘Directive  1999/45/EC  of  the  European
Parliament  and  of  the  Council  of  31  May  19998’.  The  corresponding  footnote  is
replaced by the following: ‘OJ L 200, 30.7.1999, p.1’.

Former recitals (7), (8) and (9) become recitals (9), (10) and (11) respectively and the
words  “or  mutagens”  are  inserted,  in  recitals  (9)  and  (11),  after  the  word
“carcinogens”.

Former  recital (10) becomes recital (12) and is replaced by the following: ‘(12)  ‘In
order to contribute to a reduction in these risks, limit values and other directly related
provisions should be established for all those carcinogens or mutagens for which the
available information, including scientific and technical data, make this possible.’

3.15.

Former recital (11) becomes recital (13).

3.16.

The  following  new  recitals  (14)  and  (15)  are  inserted:  “(14)  The  precautionary
principle  should  be  applied 
the  protection  of  workers’  health”  and
“(15) Preventive measures must be taken for the protection of the health and safety
of workers exposed to carcinogens or mutagens”.

in 

3.17.

Former recital (12) becomes recital (16).

3.18.

Former recital (13) becomes recital (17) and is replaced by the following text: ‘(17)
Pursuant to Council Decision 74/325/EEC10, the Commission consulted the Advisory
Committee  on  Safety,  Hygiene  and  Health  Protection  at  Work  with  a  view  to
drawing up proposals for the Council Directives codified in this Directive’.

3.19.

Former recital (14) becomes recital (18).

3.20.

The enacting formula ‘ HAS ADOPTED THIS DIRECTIVE’ is replaced by ‘HAVE
ADOPTED THIS DIRECTIVE’.

3

3.21.

Does not concern the English version.

3.22.

3.23.

In Article 1(1), Article 3(1), (2), first and second subparagraphs, and (4), Article 5(5)
(c), (d), (e) and (j), Article 6(a) and (b), Article 10(1), introductory wording, and (a),
Article  11(2),  Article  14(3),  Article  16(1),  Article  17(2)  and  Annex  II,  point  1,  the
word ‘carcinogens’ is replaced by the words ‘carcinogens or mutagens’.

Article 1(4) is replaced by the following: ‘4. As regards asbestos, which is dealt with
by  Council  Directive  83/477/EEC10,  the  provisions  of  this  Directive  shall  apply
whenever they are more favourable to health and safety at work’. The corresponding
footnote is worded as follows: ‘OJ L 263, 24.9.1983, p. 25’.

3.24.

In the second indent of Article 2(a)(ii), the words ‘Annex I to Directive 88/379/EEC’
are replaced by the words ‘Part B of Annex II to Directive 1999/45/EC.

3.25.

In Article 2, the following point (b) is inserted:

“(b) “mutagen” means:

(i)

(ii)

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;

a preparation composed of one or more substances referred to in point (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 mutagen set out in either:

– 

– 

Annex I to Directive 67/548/EEC, or

Part B of Annex II to Directive 1999/45/EC where the substance or
substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or
appear in it without concentration limits;”.

Former point (b) becomes point (c).

3.26.

3.27.

3.28.

In Article 2(c), Article 4(1), Article 5(2), and (5), introductory wording and point (a),
and  Article  14(8),  the  word  ‘carcinogen’  is  replaced  by  the  words  ‘carcinogen  or
mutagen’.

In Article 16(1) and Article 17(1), the words ‘118 A of the Treaty’  are  replaced by
the words ‘137(2) of the Treaty’.

In the first subparagraph of Article 20, the words ‘the Directive’ are replaced by the
words ‘the Directives’.

3.29.

The closing formula is completed.

3.30.

In Annex I, the following point 5 is added: ‘5. Work involving exposure to hardwood
dusts1’. The corresponding footnote is worded as follows: ‘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’.

4

3.31.

3.32.

3.33.

3.34.

3.35.

In  Annex  III,  the  reference  to  ‘(Article  16  (1))’  under  the  title  is  replaced  by  a
reference to ‘(Article 16)’ which was in Annex III to Directive 90/394/EEC.

In Part A of Annex III, the new amending act has added two names of agents (‘vinyl
chloride  monomer  and  hardwood  dusts’)  and  the  table  has  been  amended
accordingly.

In  Part  A  of  Annex  IV,  the  words  ‘and  its  amendment’  are  replaced  by  the  words
‘and  its  successive  amendments’  and  the  words  ‘Council  Directive  1999/38/EC
(OJ L 138, 1.6.1999, p. 66)’ are added. In part B of Annex IV, the following words
are  added:  ‘1999/38/EC’  (left-hand  column)  and  ’29  April  2003’  (right-hand
column).

The  ‘correlation  table’  (Annex  V)  has  been  amended  in  order  to  reflect  all  the
changes referred to above.

In Annex II, in the first line of paragraph 1, the first line of the first subparagraph of
paragraph 2 and the penultimate line of the second subparagraph of paragraph 2 the
word ‘surveillance’ is replaced by the word ‘monitoring’.

4.

To  facilitate  reading  and  examination,  the  full  text  of  the  amended  proposal  for
codification is also attached.

5

(cid:1) 90/394/EEC

Amended proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

(cid:1) 90/394/EEC (adapted)

on the protection of workers from the risks related to exposure to carcinogens (cid:1) or
mutagens (cid:2) at work (Sixth individual Directive within the meaning of Article 16(1) of
Council Directive 89/391/EEC)

(Text with EEA relevance)

(cid:1) 90/394/EEC

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular
Article 137(2) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee1,

Having regard to the opinion of the Committee of the Regions2,

Acting in accordance with the procedure laid down in Article 251 of the Treaty3,

Whereas:

(1) 

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)4  has  been  substantially  amended

(cid:1) 

1

2

3

4

OJ C […], […], p. […].
OJ C […], […], p. […].
OJ C […], […], p. […].
OJ  L  196,  26.7.1990,  p.  1.  Directive  as  last  amended  by  Directive  1999/38/EC  (OJ  L  138,  1.6.1999,
p. 66).

6

                                                
several times5. In the interests of clarity and rationality, Directive 90/394/EEC should
therefore be codified.

(cid:1) 90/394/EEC recital 5
(cid:2)1 97/42/EC recital 10
(adapted)+
1999/38/EC recital 14 (adapted)

(2) 

(3) 

Compliance with the  minimum  requirements  designed  to  guarantee  a  better  standard
of  health  and  safety  as  regards  the  protection  of  workers  from  the  risks  related  to
exposure  to  carcinogens  or  mutagens  at  work  is  essential  to  ensure  the  health  and
safety of workers (cid:2)1 and  is also intended to provide  a  level  of  minimum  protection
for all workers in the Community (cid:3) .

(cid:1) 90/394/EEC recital 6

This  Directive  is  an  individual  Directive  within  the  meaning  of  Article  16(1)  of
Council  Directive  89/391/EEC  of  12  June  1989  on  the  introduction  of  measures  to
encourage improvements in the safety  and health of  workers at work6.  Therefore the
provisions  of  that  Directive  are  fully  applicable  to  the  exposure  of  workers  to
carcinogens, without prejudice to more stringent and/or specific provisions contained
in this Directive.

(4) 

A consistent level of protection from the risks related to carcinogens or mutagens has
to be established for the Community as a whole and 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.

(cid:1) 97/42/EC recital 11

(5) 

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.

(cid:1) 1999/38/EC recital 3

(6) 

Because  of  their  mechanism  of  action,  germ  cell  mutagens  are  likely  to  have
carcinogenic effects.

(cid:1) 1999/38/EC recital 4

5

6

See Annex IV, Part A.
OJ L 183, 29.6.1989, p. 1.

7

                                                
(cid:1) 90/394/EEC recital 7 (adapted)
(7)  (cid:4) Annex  VI (cid:5)  to  Council  Directive  67/548/EEC  of  27  June  1967  on  the
approximation  of  laws,  regulations  and  administrative  provisions  relating  to  the
classification,  packaging  and  labelling  of  dangerous  substances7  contains  the
(cid:4) classification criteria and (cid:5) labelling procedures in respect of each substance.

(8) 

(cid:1) 90/394/EEC recital 8 (adapted)
Directive  (cid:4) 1999/45/EC  of  the  European  Parliament  and  of  the  Council  of
31 May 1999 (cid:5)  on  the  approximation  of  the  laws,  regulations  and  administrative
provisions of the Member States relating to the classification, packaging and labelling
of  dangerous  preparations8  contains  particulars  on  the  classification  criteria  and
labelling procedures in respect of such preparations.

(9) 

In all work situations workers must be protected in respect of preparations containing
one  or  more  carcinogens  or  mutagens  and  from  carcinogenic  (cid:4) or  mutagenic (cid:5)
compounds arising at work.

(cid:1) 97/42/EC recital 4 (adapted)

(10)  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.

(cid:1) 97/42/EC recital 5

(11)  Although current scientific knowledge is not such that a level can be established below
which  risks  to  health  cease  to  exist,  a  reduction  in  exposure  to  carcinogens  (cid:4) or
mutagens (cid:5) will nonetheless reduce those risks.

(cid:1) 90/394/EEC recital 10
(adapted)

(cid:1) 90/394/EEC recital 11
(adapted)

(12) 

In  order  to  contribute  to  a  reduction  in  these  risks,  limit  values  and  other  directly
related provisions should be established for all those carcinogens (cid:4) or mutagens (cid:5)
for which the available information, including scientific and technical data, make this
possible.

7

8

OJ  L  196,  16.8.1967,  p.  1.  Directive  as  last  amended  by  Directive  1999/33/EC  of  the  European
Parliament and of the Council (OJ L 199, 30.7.1999, p. 57).
OJ L 200, 30.7.1999, p. 1.

8

                                                
(13)  Occupational  exposure  limit  values  must  be  regarded  as  an  important  component  of
the  general  arrangements  for  the  protection  of  workers.  Such  limit  values  must  be
revised whenever this becomes necessary in the light of more recent scientific data.

(cid:1) 97/42/EC recital 8

(14)  The precautionary principle should be applied in the protection of workers’ health.

(cid:1) 1999/38/EC recital 9 (adapted)

(15)  Preventive  measures  must  be  taken  for  the  protection  of  the  health  and  safety  of

workers exposed to carcinogens (cid:4) or mutagens (cid:5) .

(cid:1) 90/394/EEC recital 12
(adapted)

(16)  This Directive constitutes a practical aspect of the realisation of the social dimension

of the internal market.

(cid:1) 90/394/EEC recital 14

(cid:1) 90/394/EEC recital 15
(adapted)+
97/42/EC recital 13 (adapted)+
1999/38/EC recital 17 (adapted)+
90/394/EEC 2nd citation
(adapted)+
97/42/EC 3rd citation (adapted)+
1999/38/EC 3rd citation (adapted)

(17)  Pursuant  to  Council  Decision  74/325/EEC9,  the  Commission  consulted  the  Advisory
Committee on Safety, Hygiene and Health Protection at Work with a view to drawing
up proposals for the Council Directives codified in this Directive.

(18)  This Directive is without prejudice to the obligations of the Member States concerning

the time limits for transposition set out in Part B of Annex IV,

(cid:1) 

9

OJ L 185, 9.7.1974, p. 15. Decision as last amended by the Act of Accession of Austria, Finland and
Sweden.

9

                                                
HAVE ADOPTED THIS DIRECTIVE:

(cid:1) 90/394/EEC

CHAPTER I

GENERAL PROVISIONS

(cid:1) 90/394/EEC

Article 1

Objective

1.

2.

3.

4.

(cid:1) 90/394/EEC
(cid:2)1 1999/38/EC Article 1 point 3

This  Directive  has  as  its  aim  the  protection  of  workers  against  risks  to  their  health
and  safety,  including  the  prevention  of  such  risks,  arising  or  likely  to  arise  from
exposure to (cid:2)1 carcinogens or mutagens (cid:3) at work.

(cid:1) 90/394/EEC

It lays down particular minimum requirements in this area, including limit values.

This  Directive shall not apply to  workers exposed  only  to  radiation  covered  by  the
Treaty establishing the European Atomic Energy Community.

Directive 89/391/EEC shall apply fully to the whole area referred to in paragraph 1,
without  prejudice  to  more  stringent  and/or  specific  provisions  contained  in  this
Directive.

As  regards  asbestos,  which  is  dealt  with  by  Council  Directive  83/477/EEC10,  the
provisions of this Directive shall apply whenever they are more favourable to health
and safety at work.

(cid:1) 1999/38/EC Article 1 point 1

10

OJ L 263, 24.9.1983, p. 25.

10

                                                
(cid:1) 97/42/EC Article 1 point 2,
Article 2

Article 2

Definitions

For the purposes of this Directive,

(a)

“carcinogen” means:

(i)

(ii)

a  substance  which  meets  the  criteria  for  classification  as  a  category  1  or  2
carcinogen set out in Annex VI to Directive 67/548/EEC;

a  preparation  composed  of  one  or  more  substances  referred  to  in  point  (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 carcinogen set out either:

– 

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

(cid:1) 97/42/EC Article 1 point 2
(adapted)

– 

in  Part  B  of  Annex  (cid:4) II  to  Directive  1999/45/EC (cid:5)  where  the
substance  or 
to
in  Annex 
Directive 67/548/EEC or appear in it without concentration limits;

substances  do  not 

appear 

I 

(iii) a substance, preparation or process referred to in Annex  I to this Directive as
well  as  a  substance  or  preparation  released  by  a  process  referred  to  in  that
Annex;

(b)

“mutagen” means:

(cid:1) 1999/38/EC Article 1 point 2

(i)

(ii)

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;

a  preparation  composed  of  one  or  more  substances  referred  to  in  point (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 mutagen set out in either:

– 

Annex I to Directive 67/548/EEC; or

11

(cid:1) 1999/38/EC Article 1 point 2
(adapted)

–  (cid:4) Part B of Annex II to Directive 1999/45/EC (cid:5) where the substance
or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or
appear in it without concentration limits;

(cid:1) 97/42/EC Article 1 point 2
(cid:2)1 1999/38/EC Article 1 point 4

(c)

“limit  value”  means,  unless  otherwise  specified,  the  limit  of  the  time-weighted
average of the concentration for a (cid:2)1 “carcinogen or mutagen” (cid:3) in the air within
the breathing zone of a worker in relation to a specified reference period as set out in
Annex III to this Directive.

(cid:1) 90/394/EEC
(cid:2)1 1999/38/EC Article 1 point 3

Article 3

Scope — determination and assessment of risks

1.

2.

This  Directive  shall  apply  to  activities  in  which  workers  are  or  are  likely  to  be
exposed to (cid:2)1 carcinogens or mutagens (cid:3) as a result of their work.

In the case of any activity likely to involve a risk of exposure to (cid:2)1 carcinogens or
mutagens (cid:3),  the  nature,  degree  and  duration  of  workers'  exposure  shall  be
determined  in  order  to make it possible  to assess any  risk  to  the  workers'  health or
safety and to lay down the measures to be taken.

The assessment shall be renewed regularly and in any event when any change occurs
in  the  conditions  which  may  affect  workers'  exposure  to  (cid:2)1 carcinogens  or
mutagens (cid:3).

The  employer  shall  supply  the  authorities  responsible  at  their  request  with  the
information used for making the assessment.

3.

When assessing the risk, account shall be taken of all other routes of exposure, such
as absorption into and/or through the skin.

(cid:1) 97/42/EC Article 1 point 3
(adapted)

12

(cid:1) 90/394/EEC
(cid:2)1 1999/38/EC Article 1 point 3

4.

When the risk assessment is carried out, employers shall give particular attention to
any  effects  concerning  the  health  or  safety  of  workers  at  particular  risk  and  shall,
inter  alia,  take  account  of  the  desirability  of  not  employing  such  workers  in  areas
where they may come into contact with (cid:2)1 carcinogens or mutagens (cid:3).

(cid:1) 90/394/EEC

CHAPTER II

EMPLOYERS' OBLIGATIONS

(cid:1) 90/394/EEC
(cid:2)1 1999/38/EC, Article 1 point 4

Article 4

Reduction and replacement

The employer shall reduce the use of a (cid:2)1 carcinogen or mutagen (cid:3) at the place of
work, in particular by replacing it, in so far as is technically possible, by a substance,
preparation or process which, under its conditions of use, is not dangerous or is less
dangerous to workers' health or safety, as the case may be.

The  employer  shall,  upon  request,  submit  the  findings  of  his  investigations  to  the
relevant authorities.

(cid:1) 90/394/EEC

Article 5

Prevention and reduction of exposure

Where  the  results  of  the  assessment  referred  to  in  Article  3(2)  reveal  a  risk  to
workers' health or safety, workers' exposure must be prevented.

Where it is not technically possible to replace the (cid:2)1 carcinogen or mutagen (cid:3) by a
substance, preparation or process which, under its conditions of use, is not dangerous

(cid:1) 90/394/EEC
(cid:2)1 1999/38/EC Article 1 point 4

13

1.

2.

1.

2.

or  is  less  dangerous  to  health  or  safety,  the  employer  shall  ensure  that  the
(cid:2)1 carcinogen  or  mutagen (cid:3)  is,  in  so  far  as  is  technically  possible,  manufactured
and used in a closed system.

3.

Where a closed system is not technically possible, the employer shall ensure that the
level of exposure of workers is reduced to as low a level as is technically possible.

4.

Exposure shall not exceed the limit value of a carcinogen as set out in Annex III.

(cid:1) 97/42/EC Article 1 point 4

(cid:1) 90/394/EEC
(cid:2)1 97/42/EC Article 1 point 4
(cid:2)2 1999/38/EC Article 1 point 4
(cid:2)3 1999/38/EC Article 1 point 3

(cid:2)1 5. (cid:3)Wherever a (cid:2)2 carcinogen or mutagen (cid:3) is used, the employer shall apply all the

following measures:

(a)

(b)

(c)

(d)

(e)

limitation of  the  quantities  of a (cid:2)2 carcinogen  or  mutagen (cid:3)  at  the  place  of
work;

keeping  as  low  as  possible  the  number  of  workers  exposed  or  likely  to  be
exposed;

design  of  work processes  and  engineering  control  measures  so  as  to  avoid  or
minimise the release of (cid:2)3 carcinogens or mutagens (cid:3) into the place of work;

evacuation  of  (cid:2)3 carcinogens  or  mutagens (cid:3)  at  source,  local  extraction
system  or  general  ventilation,  all  such  methods  to  be  appropriate  and
compatible with the need to protect public health and the environment;

use of existing appropriate procedures for the measurement of (cid:2)3 carcinogens
or  mutagens (cid:3),  in  particular  for  the  early  detection  of  abnormal  exposures
resulting from an unforeseeable event or an accident;

(f)

application of suitable working procedures and methods;

(g)

(h)

(i)

(j)

collective  protection  measures  and/or,  where  exposure  cannot  be  avoided  by
other means, individual protection measures;

hygiene  measures,  in  particular  regular  cleaning  of  floors,  walls  and  other
surfaces;

information for workers;

demarcation  of  risk  areas  and  use  of  adequate  warning  and  safety  signs
including “no smoking” signs in areas where workers are exposed or likely to
be exposed to (cid:2)3 carcinogens or mutagens (cid:3);

14

(k)

drawing up plans to deal with emergencies likely to result in abnormally high
exposure;

(l) means  for  safe  storage,  handling  and  transportation,  in  particular  by  using

sealed and clearly and visibly labelled containers;

(m) means for safe collection, storage and disposal of waste by workers, including

the use of sealed and clearly and visibly labelled containers.

(cid:1) 90/394/EEC
(cid:2)1 1999/38/EC Article 1 point 3

Article 6

Information for the competent authority

Where the results of the assessment referred to in Article 3(2) reveal a risk to workers' health
or  safety,  employers  shall,  when  requested,  make  available  to  the  competent  authority
appropriate information on:

(a)

(b)

(c)

(d)

(e)

(f)

(g)

the activities and/or industrial processes carried out, including the reasons for which
(cid:2)1 carcinogens or mutagens (cid:3) are used;

the  quantities  of  substances  or  preparations  manufactured  or  used  which  contain
(cid:2)1 carcinogens or mutagens (cid:3);

the number of workers exposed;

the preventive measures taken;

the type of protective equipment used;

the nature and degree of exposure;

the cases of replacement.

(cid:1) 90/394/EEC

Article 7

Unforeseen exposure

1.

In the event of an unforeseeable event or an accident which is likely to result in an
abnormal exposure of workers, the employer shall inform the workers thereof.

(cid:1) 90/394/EEC (adapted)

15

2.

Until  the  situation  has  been  restored  to  normal  and  the  causes  of  the  abnormal
exposure have been eliminated:

(cid:1) 90/394/EEC

(a)

(b)

only  those  workers  who  are  essential  to  the  carrying  out  of  repairs  and  other
necessary work shall be permitted to work in the affected area;

the  workers  concerned  shall  be  provided  with  protective  clothing  and
individual  respiratory  protection  equipment  which  they  must  wear;  the
exposure may not be permanent and shall be kept to the strict minimum of time
necessary for each worker;

(c)

unprotected workers shall not be allowed to work in the affected area.

Article 8

Foreseeable exposure

1.

2.

For certain activities such as maintenance, in respect of which it is foreseeable that
there is the potential for a significant increase in exposure of workers, and in respect
of  which  all  scope  for  further  technical  preventive  measures  for  limiting  workers'
the  employer  shall  determine,  after
exposure  has  already  been  exhausted, 
consultation  of  the  workers  and/or  their  representatives  in  the  undertaking  or
establishment,  without  prejudice  to  the  employer's  responsibility,  the  measures
necessary to reduce the duration of workers' exposure to the minimum possible and
to ensure protection of workers while they are engaged in such activities.

Pursuant  to  the  first  subparagraph,  the  workers  concerned  shall  be  provided  with
protective clothing and individual respiratory protection equipment which they must
wear as long as the abnormal exposure persists; that exposure may not be permanent
and shall be kept to the strict minimum of time necessary for each worker.

Appropriate measures shall be taken to ensure that  the  areas  in  which the activities
referred to in the first subparagraph of paragraph 1 take place are clearly demarcated
and indicated or that unauthorised persons are prevented by other means from having
access to such areas.

(cid:1) 90/394/EEC, art. 9 (adapted)

Article 9

Access to risk areas

Appropriate measures shall be taken by employers to ensure that access to areas in which the
activities in respect of which the results of the assessment referred to in Article 3(2) reveal a
risk to workers' safety or health take place are accessible solely to workers who, by reason of
their work or duties, are required to enter them.

16

(cid:1) 90/394/EEC
(cid:2)1 1999/38/EC Article 1 point 3

Article 10

Hygiene and individual protection

1.

Employers  shall be obliged, in the case  of  all  activities for  which there is  a  risk  of
contamination  by  (cid:2)1 carcinogens  or  mutagens (cid:3),  to  take  appropriate  measures  to
ensure that:

(a) workers  do  not eat,  drink  or  smoke  in  working  areas  where  there  is  a  risk  of

contamination by (cid:2)1 carcinogens or mutagens (cid:3);

(cid:1) 90/394/EEC

(b) workers are provided with appropriate protective clothing or other appropriate

special clothing;

(c)

separate storage places are provided for working or protective clothing and for
street clothes;

(d) workers  are  provided  with  appropriate  and  adequate  washing  and  toilet

facilities;

(e)

protective equipment is properly stored in a well-defined place and is checked
and cleaned if possible before, and in any case after, each use;

(f)

defective equipment is repaired or replaced before further use.

2.

Workers may not be charged for the cost of the measures set out in paragraph 1.

(cid:1) 90/394/EEC
(cid:2)1 1999/38/EC Article 1 point 3

Article 11

Information and training of workers

1.

Appropriate measures shall be taken by the employer to ensure that workers and/or
workers'  representatives  in  the  undertaking  or  establishment  receive  sufficient  and
appropriate  training,  on  the  basis  of  all  available  information,  in  particular  in  the
form of information and instructions, concerning:

(a)

potential  risks  to  health,  including  the  additional  risks  due  to  tobacco
consumption;

(b)

precautions to be taken to prevent exposure;

17

(c)

hygiene requirements;

(d) wearing and use of protective equipment and clothing;

(e)

steps to be taken by workers, including rescue workers, in the case of incidents
and to prevent incidents.

The training shall be:

– 

– 

adapted to take account of new or changed risk; and

repeated periodically if necessary.

2.

Employers  shall  inform  workers  of  installations  and  related  containers  containing
(cid:2)1 carcinogens  or  mutagens (cid:3),  ensure 
that  all  containers,  packages  and
installations  containing  (cid:2)1 carcinogens  or  mutagens (cid:3)  are  labelled  clearly  and
legibly, and display clearly visible warning and hazard signs.

(cid:1) 90/394/EEC

Article 12

Information for workers

(cid:1) 90/394/EEC (adapted)

Appropriate measures shall be taken to ensure that:

(a)

workers and/or any workers' representatives in the undertaking or establishment can
check that this Directive is applied or can be involved in its application, in particular
with regard to:

(i)

(ii)

the consequences for workers' safety and health of the selection, wearing  and
use of protective clothing and equipment, without prejudice to the  employer's
responsibility  for  determining  the  effectiveness  of  protective  clothing  and
equipment;

the  measures  determined  by  the  employer  which  are  referred  to  in  the  first
subparagraph of Article 8(1), without prejudice to the employer's responsibility
for determining such measures;

(b)

(c)

workers and/or any workers' representatives in the undertaking or establishment are
informed as quickly as possible of abnormal exposures, including those referred to in
Article 8, of the causes thereof and of the measures taken or to be taken to rectify the
situation;

the  employer  keeps  an  up-to-date  list  of  the  workers  engaged  in  the  activities  in
respect of which the results of the assessment referred to in Article 3(2) reveal a risk
to workers' health or safety, indicating, if the information is available, the exposure
to which they have been subjected;

18

(d)

(e)

(f)

the  doctor  and/or  the  competent  authority  as  well  as  all  other  persons  who  have
responsibility  for  health  and  safety  at  work  have  access  to  the  list  referred  to  in
point (c);

each worker has access to the information on the list which relates to him personally;

workers and/or any workers' representatives in the undertaking or establishment have
access to anonymous collective information.

(cid:1) 90/394/EEC (adapted)

Article 13

Consultation and participation of workers

Consultation  and  participation  of  workers  and/or  their  representatives  in  connection  with
matters  covered  by  this  Directive  shall  take  place  in  accordance  with  Article  11  of
Directive 89/391/EEC.

(cid:1) 90/394/EEC

CHAPTER III

MISCELLANEOUS PROVISIONS

(cid:1) 90/394/EEC Article 14
(adapted)
(cid:2)1 1999/38/EC Article 1 point 3
(cid:2)2 Corrigendum, OJ L 37
12.2.2000, p.35.

Article 14

Health surveillance

1.

2.

The Member States shall establish, in accordance with national laws and/or practice,
arrangements for carrying out relevant health surveillance of workers  for whom the
results of the assessment referred to in Article 3(2) reveal a risk to health or safety.

The arrangements referred to in paragraph 1 shall be such that each worker shall be
able to undergo, if appropriate, relevant health surveillance:

– 

– 

prior to exposure;

at regular intervals thereafter.

19

3.

4.

5.

6.

7.

8.

Those arrangements shall be such that it is directly possible to implement individual
and occupational hygiene measures.

If a worker is found to be suffering from an abnormality which is suspected to be the
result  of  exposure  to  (cid:2)1 carcinogens  or  mutagens (cid:3),  the  doctor  or  authority
responsible  for  the  health  surveillance  of  workers  may  require  other  workers  who
have been similarly exposed to undergo health surveillance.

In  that  event,  a  reassessment  of  the  risk  of  exposure  shall  be  carried  out  in
accordance with Article 3(2).

In cases where health surveillance is carried out,  an individual medical record shall
be kept and the doctor or authority responsible for health surveillance shall propose
any  protective  or  preventive  measures  to  be  taken  in  respect  of  any  individual
workers.

Information and advice must be  given to workers regarding  any  health  surveillance
which they may undergo following the end of exposure.

In accordance with national laws and/or practice:

– 

– 

workers  shall  have  access  to  the  results  of  the  health  surveillance  which
concern them; and

the workers concerned or the employer may request a review of the results of
the health surveillance.

Practical  recommendations  for  the  health  surveillance  of  workers  are  given  in
Annex II.

All  cases  of  cancer  identified  in  accordance  with  national  laws  and/or  practice  as
resulting from occupational exposure to a (cid:2)1 (cid:2)2 carcinogen or mutagen (cid:3) (cid:3) shall
be notified to the competent authority.

(cid:1) 90/394/EEC

Article 15

Record-keeping

The  list  referred  to  in  point  (c)  of  Article  12  and  the  medical  record  referred  to  in
Article 14(4) shall be kept for at least 40 years following the end of exposure, in accordance
with national laws and/or practice.

Those  documents  shall  be  made  available  to  the  responsible  authority  in  cases  where  the
undertaking ceases activity, in accordance with national laws and/or practice.

20

(cid:1) 90/394/EEC
(cid:2)1 1999/38/EC Article 1 point 3

Article 16

Limit values

1.

The Council shall, in accordance with the procedure laid down in Article 137(2) of
the Treaty, set out limit values in Directives on the basis of the available information,
including  scientific  and  technical  data,  in  respect  of  all  those  (cid:2)1 carcinogens  or
mutagens (cid:3) for which this is possible, and, where necessary, other  directly  related
provisions.

2.

Limit values and other directly related provisions are set out in Annex III.

(cid:1) 90/394/EEC
(cid:2)1 1999/38/EC Article 1 point 3

Article 17

Annexes

1.

2.

Annexes I and III may be amended in accordance only with the procedure laid down
in Article 137(2) of the Treaty.

Purely technical adjustments to Annex II in the light of technical progress, changes
in  international  regulations  or  specifications  and  new  findings  in  the  field  of
(cid:2)1 carcinogens  or  mutagens (cid:3)  shall  be  adopted  in  accordance  with  the  procedure
laid down in Article 17 of Directive 89/391/EEC.

(cid:1) 90/394/EEC

Article 18

Use of data

The Commission shall have access to the use made by the competent national authorities of
the information referred to in Article 14(8).

(cid:1) 90/394/EEC (adapted)

Article 19

Notifying the Commission

21

Member  States  shall  communicate  to  the  Commission  the  provisions  of  national  law  which
they adopt in the future in the field governed by this Directive.

(cid:1) 

Article 20

Repeal

Directive  90/394/EEC,  as  amended  by  the  Directives  referred  to  in  Annex  IV,  Part  A,  is
repealed, without prejudice to the obligations of the Member States concerning the time limits
for transposition set out in Annex IV, Part B.

References  to  the  repealed  Directive  shall  be  construed  as  references  to  this  Directive  and
shall be read in accordance with the correlation table in Annex V.

Article 21

Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.

Article 22

Addressees

This Directive is addressed to the Member States.

Done at Brussels, […]

For the European Parliament
The President
[…]

For the Council
The President
[…]

22

(cid:1) 90/394/EEC

ANNEX I

List of substances, preparations and processes

(Article 2(a)(iii))

1.

Manufacture of auramine.

Work involving exposure to polycyclic  aromatic hydrocarbons present in coal soot,
coal tar or coal pitch.

(cid:1) 97/42/EC Article 1 point 5

(cid:1) 90/394/EEC

Work  involving  exposure  to  dusts,  fumes  and  sprays  produced  during  the  roasting
and electro-refining of cupro-nickel mattes.

Strong acid process in the manufacture of isopropyl alcohol.

2.

3.

4.

5.

Work involving exposure to hardwood dusts1.

_____________

(cid:1) 1999/38/EC Article 1 point 5

1

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.

23

                                                
(cid:1) 90/394/EEC
(cid:2)1 1999/38/EC Article 1 point 3
(cid:2)2 Corrigendum, OJ L 37,
12.2.2000, p.35

ANNEX II

Practical recommendations for the health surveillance of workers

(Article 14(7))

1.

2.

The doctor and/or authority responsible for the health monitoring of workers exposed
to  (cid:2)1 (cid:2)2 carcinogens  or  mutagens (cid:3) (cid:3)  must  be  familiar  with  the  exposure
conditions or circumstances of each worker.

Health monitoring of workers must be carried out in accordance with the principles
and  practices  of  occupational  medicine;  it  must  include  at  least  the  following
measures:

– 

– 

– 

keeping records of a worker's medical and occupational history,

a personal interview,

where  appropriate,  biological  monitoring,  as  well  as  detection  of  early  and
reversible effects.

Further tests may be decided upon for each worker when he is the subject of health
monitoring,  in  the  light  of  the  most  recent  knowledge  available  to  occupational
medicine.

_____________

24

ANNEX III

Limit values and other directly related provisions

(Article 16)

(cid:1) 1999/38/EC Article 1 point 6
(adapted)

A. LIMIT VALUES FOR OCCUPATIONAL EXPOSURE

Name of
agent

EINECS1

CAS2

Limit values

Notation

mg/m3 3

ppm4

Transitional
measures

Benzene

200-753-7

71-43-2

3,255

15

Skin6

Limit value:

Vinyl
chloride
monomer

Hardwood
dusts

200-831

75-01-4

7,775

35

—

—

5,05 7

—

3 ppm (=9,75
mg/m3) (until 27
June 2003)

—

—

—

—

1

2

3

4

5

6

7

EINECS: European Inventory of Existing Chemical Substances.
CAS: Chemical Abstract Service Number.
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).
Measured or calculated in relation to a reference period of eight hours.
Substantial contribution to the total body burden via dermal exposure possible.
Inhalable fraction: if hardwood dusts are mixed with other wood dusts, the limit value shall apply to all
wood dusts present in that mixture.

25

(cid:1) 90/394/EEC

B. OTHER DIRECTLY RELATED PROVISIONS

p.m.

_____________

26

(cid:6)

ANNEX IV

Part A
Repealed Directive and its successive amendments
(referred to by Article 20)

Council Directive 90/394/EEC

(OJ L 196, 26.7.1990, p. 1)

Council Directive 97/42/EC

(OJ L 179, 8.7.1997, p. 4)

Council Directive 1999/38/EC

(OJ L 138, 1.6.1999, p. 66)

Part B
Deadlines for transposition into national law
(referred to by Article 20(1))

Directive

Deadline for transposition

90/394/EEC

97/42/EC

1999/38/EC

31 December 1992

27 June 2000

29 April 2003

_____________

27

ANNEX V

CORRELATION TABLE

Directive 90/394/EC

This Directive

Article 1

Article 2(a)

Article 2(aa)

Article 2(b)

Articles 3 to 9

Article 10(1)(a)

Article 10(1)(b), first sentence

Article 1

Article 2 (a)

Article 2(b)

Article 2 (c)

Article 3 to 9

Article 10(1)(a)

Article 10(1)(b)

Article 10(1)(b), second sentence

Article 10(1)(c)

Article 10(1)(c)

Article 10(1)(d)

Article 10(1)(d), first and second sentences

Article 10(1)(e)

Article 10(1)(d), third sentence

Article 10(1) (f)

Article 10(2)

Articles 11 to 18

Article 19(1) first subparagraph

Article 19(1) second subparagraph

Article 19(1) third subparagraph

Article 19(2)

––––––––

––––––––

Article 20

Annex I

Annex II

Annex III

––––––––

––––––––

Article 10 (2)

Articles 11 to 18

––––––––

––––––––

––––––––

Article 19

Article 20

Article 21

Article 22

Annex I

Annex II

Annex III

Annex IV

Annex V

28