OPINION OF THE COMMISSION on the amendments proposed by the European Parliament to the Council' s common position on the proposal for a COUNCIL DIRECTIVE on the protection of workers from the risks related to exposure to carcinogens at work
Date: 1996-07-24
Institutions: European Commission
Subjects: carcinogenic substance, health risk, hydrocarbon, occupational health, occupational safety

COMMISSION  OF THE  EUROPEAN  COMMUNITIES 

Brussels,  24.07  1996 
COM(96) 414  final 

95/0229  (SYN) 

OPINION  OF THE  COMMISSION 
on the amendments proposed  by the European  Parliament 
to the Council's common  position  on the 

proposal  for  a 
COUNCIL  DIRECTIVE 

on the protection  of workers from  the risks related  to 

exposure  to carcinogens  at work 

(presented  by the Commission  pursuant to Article  189 c (d) of the EC Treaty) 

EXPLANATORY  MEMORANDUM 

The  initial  proposal  for  this  amendment  to  the  Directive  was  presented  by  the 
Commission  to the Council  on  14 September  19951. 

The main aims are the removal  of the existing  exclusion  in Directive 90/394/EEC of a 
whole series of preparations containing carcinogens and the laying down of a limit value 
for occupational  exposure to benzene,  a well-known  carcinogen. 

The European Parliament  and the Economic  and Social  Committee  gave  their opinion 
on 20 June  19962 and 31 January  19963 respectively. 

In drawing up this amended  proposal,  the Commission  took  into account  for  the most 
part the amendments from the European Parliament and suggestions put forward by the 
Economic  and Social  Committee,  and in particular: 

a) 

b) 

c) 

d) 

the role of biological  monitoring in health surveillance  for exposed workers; 

the need for coherence with other Community  acts on the same subject; 

the  advisability  of  having  a  uniform  method  for  measuring  benzene 
concentrations in air and for analysis; 

the advisability  of including the derogation concerning primary  synthesis in the 
production of materials for perfumes among the temporary  derogations relating 
to limit values for benzene. 

This amendment is presented by the Commission under the terms of Article  189a(2) of 
the Treaty. 

1 

OJ C 317, 28.11.1995, p.16. 
OJ 
OJ C 97,  1.04.1996,  p.25. 

A 

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

(Text  with  EEA  relevance) 

COMMISSION PROPOSAL 

AMENDED  COMMISSION 
PROPOSAL 

THE COUNCIL OF THE EUROPEAN 
UNION, 

THE COUNCIL  OF THE EUROPEAN 
UNION, 

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

to  Council  Directive 
Having  regard 
90/394/EEC  of  28  June  1990  on  the 
protection of workers from the risks related 
to exposure to carcinogens at work(1), and 
in particular Article  16, 

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

cooperation  with 

In 
Parliament(3), 

the  European 

1 

Having  regard  to  the  opinion  of  the 
Economic  and Social  Committee(4), 

of 

Whereas  Article  118a  of  the  Treaty 
provides  that  the  Council  shall  adopt,  by 
directives,  minimum 
means 
requirements 
encouraging 
for 
improvements,  especially  in  the  working 
environment,  to  ensure  a  better  level  of 
protection  of  the  safety  and  health  of 
workers; 

Whereas,  under  the  terms  of  that Article, 
such  directives  are  to  avoid  imposing 
administrative, 
legal 
constraints  in  a  way  which  would  hold 
back  the  creation  and  development  of 
small  and medium-sized undertakings, 

financial 

and 

Whereas the Commission's communication 
on  its  programme  in  the  field  of  safety, 
hygiene and health at the workplace (1996-
2000)(5)  provides  in  particular  for  the 
continuation  of  work  on  setting  limit 
values for exposure  at the workplace; 

Whereas  Commission  Directive 
91/325/EEC(6)  of  1 March  1991  adapting 
to  technical  progress  for  the  twelfth  time 
Council  Directive  67/548/EECO  on  the 
approximation of the laws, regulations and 
administrative  provisions  relating  to  the 
classification,  packaging  and  labelling  of 
dangerous substances introduces in Annex 
in  new risk phrases to indicate the health 
hazards resulting from prolonged exposure 
and the risk of cancer through inhalation; 

Whereas  in  all  work  situations  workers 
must  be  protected 
respect  of 
preparations  containing  one  or  more 
carcinogens 
carcinogenic 
compounds arising at work; 

from 

and 

in 

Whereas  in  all  work  situations  workers 
respect  of 
must  be  protected 
preparations  containing  one  or  more 
carcinogens; 

in 

Whereas, for some agents it is necessary to 
consider all absorption pathways, including 
the  possibility  of  penetration  through  the 
skin,  in  order  to  ensure  the  best  possible 
level  of protection; 

Whereas the wording of point 2 of Annex 
I  to  Directive  90/394/EEC  relating  to 
polycyclic  aromatic  hydrocarbons  has 
posed  problems  of  interpretation  in many 
Member States;  whereas, therefore, a new, 
more precise wording is called for; 

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

including 

exposure 

Whereas  occupational 
limit 
values  must  be  regarded  as  an  important 
component of the general arrangements for 
the  protection  of  workers;  whereas  such 
limit values must be revised whenever this 
becomes  necessary  in  the  light  of  more 
recent scientific data; 

Whereas benzene is a carcinogen  which is 
present  in  many  work  situations whereas, 
therefore,  a large  number  of  workers  are 
exposed to a potential health risk; whereas, 
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  benzene  will 
nonetheless reduce these  risks; 

Whereas  the  respect  of  the  minimum 
requirements  on  the  protection  of  health 
and  safety  of  workers  from  the  specific 
risks  related  to  carcinogens  ensures  not 
only the protection of the health and safety 
of each individual worker but also provides 
a  level  of  minimum  protection  of  all 
workers  in  the  Community  which  avoids 
any  possible  distortion  in  the  area  of 
competitiveness; 

Whereas benzene is a carcinogen which is 
present in many work  situations; whereas, 
therefore,  a  large  number  of  workers  are 
exposed to a potential health risk; whereas, 
although  current  scientific  knowledge 
classifies  benzene  among  the  substances 
for  which  a  level  cannot  be  established 
below which risks to health cease to exist, 
a  reduction  in  exposure  to  benzene  will 
nonetheless  reduce these  risks; 

Whereas  it  is  important  to  set  biological 
limit  values  to  carcinogens  in  order  to 
estimate  the  level  of  absorption  of  other 
routes  than  the  breath.  Because  bio-
monitoring  is  an  important  procedure  for 
the 
assessing  benzene 
Commission  should  propose  a  biological 
limit value for benzene without delay; 

exposure, 

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  which 
avoids  any  possible  distortion  in  the area 
of competitiveness; 

Whereas  all  the  directives  concerning 
protection  of  the  health  of  workers  at the 
the  directives 
place  of  work  and 
concerning protection of public health and 
of the general  environment  must reflect  a 
single  overall  vision  of  socio-economic 
development  in the European  Community 
whereas  the  measures  taken  concerning 
benzene  under the  present  Directive  must 
therefore  be  consistent  with  the  aims and 
provisions of Directive 94/63/EC(*) on the 
control  of  volatile  organic  compound 
emissions (and thus of benzene emissions) 
resulting from the storage of petrol  and its 
distribution  from  terminals  to  service 
stations; 

Whereas  provision  should  be  made  to 
ensure  the  protection  of  the  health  and 
safety of workers concerned, in the case of 
derogations 
specified 
activities  or  sector  of  activity  where  the 
implementation of the limit value proposed 
for  benzene  may  be  difficult  to  meet 
within the date proposed; 

provided 

for 

Whereas in most small  and medium  sized 
enterprises where the main use of benzene 
might be as a solvent,  provisions to lower 
exposure  will  not  be  required  as  legal 
provisions  already  exist  in  nearly  all  the 
member  States  to  restrict  or  prohibit  its 
use. 

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  not  by  detailed  prescriptive 
requirements  but  by  a  framework  of 
general principles to enable Member States 
to  apply 
the  minimum  requirements 
consistently; 

Whereas  this  amendment  constitutes  a 
practical  aspect  of  the  realisation  of  the 
social  dimension  of the internal market; 

pursuant 

Whereas, 
to  Decision 
74/325/EECO,  as  last  amended  by  the 
1985  Act  of  Accession,  the  Advisory 
Committee on Safety,  Hygiene and Health 
Protection  at  Work  is  to  be  consulted  by 
the Commission with a view to drawing up 
proposals in this field, 

HAS ADOPTED  THIS  DIRECTIVE: 

Article  1 

Article 1 

Directive  90/394/EEC  is  hereby  amended 
as  follows: 

1.  Article  2  shall  be  replaced  by  the 

following: 

"For the purposes  of this Directive, 

(a) 

"carcinogen" means: 
i) 

a  substance  which  meets  the 
requirements for classification  as 
category  1  or  2  carcinogen 
the  criteria  of 
according 
to 
of  Directive 
Annex  VI 
67/548/EEC(7). 

ii)  a  preparation  composed  of  one 
or more substances referred  to in 
point 
the 
(a)i)  where 
concentration  of  one or  more of 
the  individual  substances  meets 
for 
t he 
r e q u i r e m e n ts 
the 
concentration 
classification  of a preparation  as 
a category  1  or 2 carcinogens set 
out  either: 

limits 

for 

in  Annex  I  to  Directive 
67/548/EEC 
or 

in  Annex  I  of  Directive 
88/379/EEC(10)  where  the 
substance  or  substances  do 
not  appear  in  Annex  I  to 
Directive  67/548/EEC  or 
appear 
it  without 
in 
concentration limits. 

iii)  a  substance,  preparation  or 
process referred to in Annex I as 
well 
or 
preparation released by a process 
referred  to in Annex I. 

substance 

as 

a 

(b)  "limit value" means, unless otherwise 
specified,  the  limit  of  concentration 
for  a  "carcinogen"  in  the  air within 
the breathing zone of a worker." 

(b)  "limit value" means, unless otherwise 
specified,  the  limit  of  concentration 
for  a  "carcinogen"  within 
the 
breathing  zone  of  a  worker  in 
relation  to  an  appropriate  reference 
period.  Breathing  zone  is  the  space 
from  where  he  takes  his  breath.  It 
shall  be  forbidden  to  exceed  this 
value. 

(c)  "biological  limit  value"  means  the 
limit  of 
the 
concentration 
appropriate biological medium, of the 
relevant  agent,  its  metabolite,  or an 
indicator  of  effect.  It  shall  be 
forbidden to exceed this value. 

in 

2.  Article 3(3)  shall  be replaced by the 

following: 

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

3. 

In  Article 
paragraph shall be added: 

the 

16, 

following 

"3. In the case of derogations provided 
for  in  Annex  m,  the  Member  States 
to  ensure  that 
shall  be  obliged 
employers  comply  with  procedures 
and measures in order to take adequate 
precautions  to  protect  the  health  and 
safety  of the workers concerned." 

4. 

Item 2 of Annex I shall be replaced by 
the following: 

exposure 

involving 

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

5.  Part A  of Annex III shall  be replaced 

by the following: 

10 

"A.  LIMIT VALUES FOR 
OCCUPATIONAL  EXPOSURE 

Nome 
of agent 

Elnecs  CAS 
(1) 

(2) 

Limit values 
nag/m1 (3)  ppm  (4) 

Notation 

Derogations 

Benzene  200-753-7  71-43-2 

3.25(5) 

1(5) 

Skin (6) 

Limit value:  3 ppm 
(-9.75  mg/m')  until  31 
December 2000 for the 
following  activities or 
sector of activity: 

Selected sites in coke 
plants (primary coolers, 
benzol/suiphatehouses, 
benzol storage and 
loading) 
-  cleaning and 

maintenance of tanks 
loading and unloading 
of tanker 
vessels and lorries 

•  marine transport 
•  motor vehicle repair 

shops 

-  service  station with 

filling 
-  attendant 

Nome 
of agent 

Elnecs  CAS 
(1) 

(2) 

Limit values 
mg/m1 (3)  ppm (4) 

Notation 

Derogations 

Benzene  200-753-7  71-43-2 

3.25  (5)  1  (5) 

Skin (6) 

Limit value:  3 ppm 
(-9.75  mg/m1)  until  31 
December  2000 for the 
following  activities or sector 
of activity: 
•  Selected  sites in coke 

plants (primary coolers, 
benzol/sulphate houses, 
benzol storage and 
loading) 

•  cleaning and maintenance 

• 

of tanks 
loading and unloading of 
tanker 

-  vessels  and lorries 
-  marine transport 
-  motor vehicle repair 

shops 

•  service station with 

filling 
attendant 

-  primary synthesis in 
fragance material 
production 

(1) 
(2) 
(3) 
(4) 
(5) 
(6) 

EINECS: European  Inventory  of  Existing  Chemical  Substances 
CAS: Chemical  Abstract  Service  Number 
mg/m* -  milligrams  per cubic metre  of air at  20 C and  101J  KPa (760 mm mercury  pressure) 
ppm -  parts per million  by volume  in air (ml/m*). 
Measured  or calculated  in  relation  to a  reference  period  of  eight  hours. 
Substantial  contribution  to the total  body  burden  via  dermal  exposure  possible." 

Biological 
limit 
value<s) 

p.m. 

11 

Part  B  of  Annex  III  shall  be  replaced by 
the following: 

"B.  OTHER  DIRECTLY  RELATED 
PROVISIONS 

Benzene 

the  measuring  procedure,  CEN 

For 
689:1995  should be used  preferentially. 

In  the  absence  of  a  uniform  analytical 
method,  at  Community  level,  Member 
States shall provide the method to be used. 

Article 2 

1.  Member  States  shall  bring  into  force 
the laws, regulations and administrative 
provisions  necessary  to  comply  with 
this  Directive  not 
later  than  31 
December  1998.  They  shall  forthwith 
inform  the Commission  thereof. 

When  Member  States  adopt  these 
these  shall  contain  a 
provisions, 
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 

12 

Article  3 

This Directive is addressed to the Member 
States. 

1.  OJNoL  196, 26.7.1990, p. 1 

2.  OJC317,  28.11.1995, p. 16 

3.  OJ 

4.  OJ C 97, 01.04.1996, p. 25 

5.  COM(95) 282  final 

6.  OJNoL  180, 8.7.1991, p. 1 

7.  OJNoL  196,  16.8.1967, p. 1 

8.  OJ No L 365, 31.12.1994, p. 24 

9.  OJ No L  185, 9.7.1974, p. 15 

10. OJ No L  187,  16.7.1988, p. 14 

U 

ISSN 0254-1475 

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