Re-examined proposal for a Council Directive on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
Date: 1998-03-10
Institutions: European Commission
Subjects: chemical product, dangerous substance, health risk, occupational health, occupational safety

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 10.03.1998 
COM(1998) 162 final -  SYN 459 

Re-examined proposal for a 

COUNCIL DIRECTIVE 

on the protection of the health and safety of workers from the risks related to chemical 
agents at work (fourteenth individual Directive within the meaning of Article 16(1) of 
Directive 89/391/EEC) 

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

1 

EXPLANATORY  MEMORANDUM 

The  initial  proposal  was  adopted  hy  the  Commission  on  14  May  1993 and  forwarded 
lo Council  on  17 May  I993(l). 

The  aim  of.the  proposal  is  to  lay  down  minimum  requirements  for  the  protection  of 
workers  from  risk  to their safety  and  health  arising  from  the effects  of chemical  agents 
that  are present  at the workplace  or as a result of any  work  activity  involving  chemical 
agents. 

Further  to  the  first  reading  at  the  European  Parliament,  the  Commission  forwarded  an 
amended  proposal  to the Council  on 9 June  1994(2). 

On  account  of significant  divergences  in  delegations'  positions,  work  on  the  amended 
proposal  was  suspended  in  1994 and  only  resumed  on  the  basis  of  a compromise  text 
put  forward  by  the  Irish  Presidency  in October  1996. 

On  7  October  1997  a  common  position'1'  was  adopted  by  the  Council  laying  down 
general  principles  covering  all  chemical  agents.  The common  position  reflected  most 
of  (he  principles  proposed  by  the  Commission  and  was  therefore  supported.  In 
particular  the  common  position  accepted  the  existence  of  two  kinds  of  occupational 
limit  values  (indicative  and  binding).  It confirmed  the  Commission's  proposal  that  in 
conformity  with  Directive  89/391/EEC,  the  employer  shall  assess  any  risk  to  the 
safety  and  health  of workers,  but  additionally  it defined  the  type of  risk  assessment  to 
be  undertaken  for the  hazardous chemical  agents at work.  It also  provided  more  details 
relating  lo  health  surveillance  for  workers  exposed  to  hazardous  chemical  agents  by 
introducing  in the text  requirements  mentioned  in the Annex  of the amended  proposal. 
On  the  other  hand  the  common  position  did  not  include  some  technical  requirements 
which  were  included  in  the  Annex  of  the  Commission's  amended  proposal,  e.g. 
requirements  in  respect  of  measuring  procedures,  and  in  respect  of  specific  protective 
measures. 

The  European  Parliament  at  its  second  reading  proposed  12  amendments  lo  the 
common  position  adopted  by  the Council. 

O JC  165,16.6.1993,  p. 4 
O.IC  191,  14.7.1994,  p.7 
O J C 3 7 5,  10.12.1997, p. 1 

tflL 

The  Commission  has  agreed  on  9  amendments  (plus  one  part  amendment),  which  it 
considers  improve  the  text  of  the  common  position.  The  amendments  draw  particular 
attention  to  the  training  of  and  information  to  workers,  to  the  need  to  make  cross 
reference  to  particular  Directives  such  as  Directive  89/654/EEC0  concerning  the 
minimum  safety  and  health  requirements  for  the  workplace,  directive  89/656/EEC(,)  on 
the  minimum  health  and  safety  requirements  for  the  use  by  workers  of  personal 
protective  equipment  at  the  workplace,  Directive  92/85/EEC(6)  on  the  introduction  of 
measures  to  encourage  improvements  in  the  safety  and  health  at  work  of  pregnant 
workers  and  workers  who  have  recently  given  birth  or  are  breastfeeding  and  Directive 
94/33/1 ;MC{1) on  (he  protection  of young  people at  work  and  to  appropriate  actions  to 
be  taken  by  the  Commission  for  closer  harmonization  in  the  field  of  occupational 
exposure  limits. 

The  legal  consistency  under  Article  8  the  Commission  has  also  inserted  reference  to 
Article  12 of Directive  89/39 l/EEC  to  align  the text  with  the title of the  Article. 

This  re-examined  proposal  contains  the  amendments  accepted  by  the  Commission  and 
is presented  by the Commission  under the terms of article  189 C(d) of the Treaty. 

(4) 
(5) 
(6) 
(7) 

OJ No L 393, 30.12.1989, p. 1 
OJ No L 393, 30.12.1989, p. 18 
OJ No L 348, 28.11.1992, p. 1 
OJ No L 216, 20.8.1994, p. 12 

It. 

Re-examined  proposal  for  a 

COUNCIL  DIRECTIVE 

on the protection  of the health  and  safety  of workers from  the risks related  to  chemical  agents 
at  work  (fourteenth  individual  Directive within  the meaning of Article  16(1) of  Directive 
89/391/EEC) 

(Text  with  EEA  relevance) 

PREVIOUS  TEXT 

AMENDED  TEXT 

THE  COUNCIL  OF  THE  EUROPEAN 
UNION, 

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

Having  regard  to  the  proposal  from  the 
Commission0',  drawn  up  after  consultation 
with  the  Advisory  Committee  on  Safety, 
Hygiene and  Health  Protection  at  Work, 

Having  regard 
to 
Economic  and  Social  Committee(2), 

the  Opinion  of 

the 

Acting  in  accordance  with  the  procedure 
laid  down  in Article  189c of the Treaty(3), 

( i) 

(2) 

(3) 

OJNoC  165,  16.6.1993, p.  4. 
OJNoC  34,  2.2.1994, p. 42. 
Opinion of the European  Parliament of 20 April  1994 (OJ NoC  128, 9.5.1994, p.  167), Council 
common position or 7 October  1997 (O.J. C 375,  10.12.1997, p.  1) and Decision of the European 
Parliament of 

(not yet published  in the Official  Journal). 

(1)  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  guarantee  a 
better  level  of  protection  of  the  safety  and 
health  of workers; 

to  that  Article, 
(2)  Whereas,  pursuant 
imposing 
avoid 
shall 
such  Directives 
administrative, 
legal 
financial 
constraints  in a way  which  would  hold  back 
the  creation  and  development  of  small  and 
medium-sized  undertakings; 

and 

the 

improvement 

of 
(3)  Whereas 
workers'  safety,  hygiene  and  health  at  work 
is  an  objective  which  should  not  be 
subordinated 
economic 
considerations; 

purely 

to 

(4)  Whereas 
the  respect  of  minimum 
requirements  on  the protection  of the  health 
and  safety  of workers  from  the  risks  related 
to  chemical  agents  aims  to  ensure  not  only 
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 
the  area  of 
any  possible  distortion 
competition; 

in 

a 

from 

level 
related 

consistent 
risks 

of 
(5)  Whereas 
protection 
to 
the 
chemical  agents  has  to  be  established  for 
the  Community  as  a  whole;  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 
the  minimum 
to  apply 
requirements  consistently; 

(6)  Whereas  a  work  activity 
involving 
chemical  agents  is  likely  to  expose  workers 
to  risk; 

Council 

(7)  Whereas 
Directive 
80/1107/EEC  of  27  November  1980 on  the 
protection  of workers  from  the  risks  related 
to  chemical,  physical  and 
to  exposure 
agents  at  work(4),  Council 
biological 
Directive  82/605/EEC  of  28 July  1982  on 
the  protection  of  workers  from  the  risks 
related  to  exposure  to  metallic  lead  and  its 
ionic  compounds  at  work  (first  individual 
Directive  within  the  meaning  of  Article  8  of 
Directive  80/1107/EEC)(5) 
and  Council 
Directive  88/364/EEC  of  9 June  1988  on 
the  protection  of workers  by the  banning  of 
certain  specific  agents  and/or  certain  work 
activities  (fourth  individual  Directive  within 
the  meaning  of  Article  8  of  Directive 
80/1107/EEC)(r,), 
of 
sake 
for 
consistency  and  clarity  as  well  as 
for 
technical  reasons,  should  be  revised  and 
included  in  a  single  Directive  laying  down 
minimum  requirements  for  the  protection  of 
the  health  and  safety  of  workers  in  work 
activities 
agents; 
whereas  these  Directives  can be  repealed; 

involving 

chemical 

the 

is 

16(1) 

this  Directive 

(8)  Whereas 
an 
individual  Directive  within  the  meaning  of 
of  Council  Directive 
Article 
the 
89/391/EEC  of 
introduction  of  measures 
to  encourage 
improvements  in  the  safety  and  health  of 
workers  at  work<7) ; 

12 June  1989  on 

(9)  Whereas  therefore  the  provisions  of 
the  said  Directive  apply 
the 
exposure  of  workers  to  chemical  agents, 
without  prejudice  to  more  stringent  and/or 
specific 
this 
Directive; 

provisions 

contained 

in  full 

to 

in 

14) 

(5) 

(6) 

17) 

OJ No L 327, 3.12.1980, p. 8.  Directive as last amended by DirecUve 88/642/EEC (OJ No L 356, 
24.12.1988, p. 74). 
OJ No L 247, 23.8.1982, p. 12. 
OJ No L  179,  9.7.1988, p. 44. 
OJ No L  183, 29.6.1989, p.  1. 

stringent 

(10)  Whereas  more 
and/or 
specific  provisions  relating  to  the  transport 
of  hazardous  chemical  agents  are  contained 
in  binding 
international  agreements  and 
conventions  incorporated  into  Community 
provisions  on  transport  of dangerous  goods 
by road,  rail, water  and  air; 

88/379/EEC(9)  on 

(11)  Whereas  in  Directive  67/548/EEC(8) 
the 
and  Directive 
approximation  of  the  laws,  regulations  and 
administrative  provisions  relating  to 
the 
classification,  packaging  and  labelling  of, 
substances  and 
respectively,  dangerous 
preparations, 
laid  down  a 
the  Council 
system  of  criteria  for  the  classification  of 
dangerous  substances  and  preparations, 

(12)  Whereas  the  definition  of  hazardous 
chemical  agent  should  include  any  chemical 
substance  which  meets  these  criteria  and 
also  any  chemical  substance  which  whilst 
not  meeting  these  criteria  may  because  of 
or 
its 
toxicological  properties,  and  the  way  it  is 
used  or  is present  in the  workplace,  present 
a  risk  to the safety  and  health  of workers; 

physico-chemical, 

chemical 

of 

specific 

information 

(13)  Whereas  in  Directive  90/492/EEC(,(,) 
the  Commission  defined  and  laid  down  a 
on 
system 
dangerous  substances  and  preparations,  in 
the  form  of  safety  data  sheets  principally 
intended  for  industrial  users  to  enable  them 
to  take  the  measures  necessary  to  ensure 
the  protection  of  the  safety  and  health  of 
workers;  whereas  Council  Directive 
the 
92/58/EEC  of  24 June 
minimum  requirements  for  the  provision  of 
safety  and/or  health  signs  at  work  (ninth 

1992  on 

(8) 

(3) 

(10) 

OJ No  196,  16.8.1967, p.  1.  Directive as last amended by Directive 96/56/EC (OJ No L 236, 
IH.9.1996, p. 35). 
OJ  No L  187,  16.7.1988, p.  14.  Directive as last amended by Commission  Directive %/65^EC 
(OJ  No L 265,  18.10.1996, p.  15). 
OJNoL275,  5.10.1990, p. 35. 

individual  Directive  within  the  meaning  of 
Article  16(1)  of  Directive  89/391/EEC)(,,) 
establishes  a system  for  marking  containers 
and pipes used  for  dangerous  substances  or 
preparations at work; 

(14)  Whereas  the  employer  should  assess 
any  risk  to  the safety  and  health of  workers 
arising  from  the  presence  of  hazardous 
chemical  agents  at  the  workplace,  in  order 
the  necessary  preventive  and 
to 
protective  measures 
this 
Directive; 

set  out 

take 

in 

the  preventive  measures 
(15)  Whereas 
identified  by  the  assessment  of  risk  and 
taken  by the  employer  should  be  consistent 
with  the  need  to  protect  public  health  and 
the environment; 

to 

and 

supplement 

(16)  Whereas, 
the 
information  available  to  workers  so  as  to 
ensure an improved  level  of  protection,  it is 
necessary 
their 
for  workers 
representatives  to  be  informed  about  the 
risks  which  chemical  agents  can  pose  for 
their  safety  and  health  and  about  the 
measures  necessary  to  reduce  or  eliminate 
those  risks, and for them to  be in a position 
to  check 
that  the  necessary  protective 
measures are taken; 

for  whom 

(17)  Whereas  the  health  surveillance  of 
workers 
the  results  of  the 
aforementioned  assessment  reveal  a  risk  to 
health,  can contribute  to  the prevention and 
protection  measures  to  be  undertaken  by 
the employer; 

(18)  Whereas  the  employer  must  on  a 
regular  basis  carry  out  evaluation  and 
measurements  and  be  aware  of  new 
developments  in  technology  with  a view  to 
improving  the  protection  of  workers'  safety 
and health; 

1111 

OJ No L 245, 26.8.1992, p. 23. 

the 
evaluated 

(19)  Whereas 
should 
scientists 
setting  occupational  exposure  limit  values; 

latest  scientific  data 
independent 
in 

the  Commission 

to  assist 

by 

be 

(20)  Whereas,  although 
in  some  cases 
scientific  knowledge  may  not  be such  that  a 
level  of  exposure  to  a  chemical  agent  can 
be  established  below  which  risks  to  health 
cease  to  exist,  a  reduction  in  exposure  to 
these  chemical  agents  will  nonetheless 
reduce these risks; 

indicative 

(21)  Whereas  in  Directive  91/322/EEC(,2) 
and  Directive 96/94/EC<l3)  the  Commission 
laid  down 
limit  values  as 
provided 
for  by  Directive  80/1107/EEC; 
whereas  the  former  Directives  should  be 
maintained 
current 
framework ; 

part 

the 

as 

of 

in 

by 

assist 

necessary 

to 
making 

technical 
(22)  Whereas 
to  this  Directive  should  be 
adjustments 
drawn 
in 
the  Commission 
up 
cooperation  with  the  Committee  set  up  by 
the 
Directive 89/391/EEC 
Commission 
technical 
individual  Directives 
to 
adaptations 
adopted  under 
that 
Directive;  whereas  the  Commission,  after 
first  seeking  the  advice  of  the  Advisory 
Committee  on  Safety,  Hygiene  and  Health 
Protection  at  Work 
in  accordance  with 
Decision  74/325/EEC<N),  should  also  draw 
up practical  guidelines  for  the application  of 
this  Directive; 

framework  of 

the 

the 

(23)  Whereas 
repeal  of  Directive 
80/1107/EEC  must  not  give  rise  to  the 
lowering  of the present  standards  of  worker 
from  chemical,  physical  and 
protection 
standards 
agents;  whereas 
biological 
resulting  from  the  existing  Directives  on 

,12) 
'13) 
(14) 

OJNoL  177,  5.  7.1991, p. 22 
OJ No L 338, 28.12.1996, p. 86 
OJ  No L 185, 9.7.1974, p.  15  Decision as last amended  by the  1994 Act of Accession. 

biological  agents,  the  proposed  Directive 
on  physical  agents,  this  Directive  and  any 
amendments  to  these  texts  should  rellect 
and  at  least  maintain  the  standards  laid 
down  in the said  Directive; 

(24)  Whereas  this  Directive  is  a  practical 
the  social 
towards  creating 
contribution 
dimension  of the internal  market 

HAS ADOPTED  TINS  DIRECTIVE: 

SECTION  I 
GENERAL  PROVISIONS 

Article I 

Objective  and  scope 

requirements 

I.  This  Directive,  which  is  the  fourteenth 
individual  Directive  within  the  meaning  of 
Article  16( I) of Directive  89/391/EEC,  lays 
down  minimum 
the 
protection  of  workers  from  risks  to  their 
safety  and  health  arising,  or  likely  to  arise, 
from  the  effects  of  chemical  agents  that  are 
present  at  the  workplace  or  as  a  result  of 
any  work 
chemical 
agents. 

involving 

activity 

for 

2.  The  requirements  of  this  Directive  apply 
where  hazardous  chemical  agents  are 
present  or  may  be present  at  the  workplace, 
without  prejudice 
the  provisions  for 
to 
chemical  agents  to  which  measures  for 
radiation  protection  apply  pursuant 
to 
the  Treaty 
Directives 
establishing  the  European  Atomic  Energy 
Community. 

adopted 

under 

this  Directive 

3  For  carcinogens  at  work  the  provisions 
of 
shall  apply  without 
prejudice  to  more  stringent  and/or  specific 
provisions  contained  in  Council  Directive 
90/394/EEC  of  28 June  1990  on 
the 
protection  of workers from the risks related 
to exposure  to carcinogens  (sixth  individual 
Directive  within  the  meaning  of  Article 
16(1) of Directive  89/39l/EEC)(,5). 

4.  The  provisions  of  Directive  89/391/EEC 
shall  apply  fully  to  the  whole  field  referred 
to in this Article,  without  prejudice  to  more 
provisions 
stringent 
contained  in this Directive. 

specific 

and/or 

Directive 

individual  directives, 

4  The  provisions  of  Directive  89/391/EEC 
and  subsequent 
in 
89/654/EEO"0 
particular 
concerning  the  minimum  safety  and  health 
requirements  for  the  workplace.  Directive 
89/656/EEC(17>  on  the  minimum  health  and 
safety  requirements  for  the  use  by  workers 
of  personal  protective  equipment  at  the 
workplace.  Directive  92/85/EEC(18)  on  the 
introduction  of  measures  to  encourage 
improvements  in  the  safety  and  health  at 
work  of  pregnant  workers  and  workers 
who  have  recently  given  birth  or  are 
breastfeeding  and  Directive  94/33/EEC(>9) 
on. the  protection  of young  people  at  work. 
shall  apply  fully  to  the  whole  field  referred 
to  in this Article,  without  prejudice  to  more 
stringent 
provisions 
contained  in this  Directive. 

specific 

and/or 

agents 

5.  As  far  as  the  transport  of  hazardous 
the 
is 
chemical 
provisions  of  this  Directive  shall  apply 
without  prejudice  to  more  stringent  and/or 
specific  provisions  contained  in  Directive 
94/55/EC (20),  in  Directive  96/49/EC (21),  in 

concerned, 

(15) 

(17) 

( I X) 

(20) 

OJNoL  196, 26.7.1990, p.  I. 
OJ No I. 393, 30.12.1989. p.  I 
OJ No I-393,  30.12.1989, p. 18 
OJ No L  348, 28.11.1992, p.  I 
OJ No L 216, 20.8.1994, p.  12 
Council  Directive 94/55/EC of 21 November  1994 on the approximation  of ihc laws of the Member 
Stales with  regard  to the transport  of dangerous goods by road 
(OJ No L 319,  12.12.1994, p. 7).  Directive as amended by Commission  Directive 96/86/EC (OJ No L 
335, 24.12.1996, p. 43). 

the 

IMDG  Code, 
the  provisions  of 
IBCCode  and  1GC  Code  as  defined 
in 
Article  2  of  Directive  93/75/EEC  (22),  in  the 
provisions  of 
the  European  Agreement 
concerning  the  International  Carriage  of 
Dangerous  Goods  by  Inland  Waterway  and 
the  Carriage  of 
of 
for 
Dangerous  Substances  on 
the  Rhine  as 
incorporated  in  Community  law  and  in  the 
technical  instructions  for  the  safe  transport 
of  dangerous  goods  issued,  at  the  date  of 
entry  into  force  of  this  Directive,  by  the 
International  Civil  Aviation  Organization. 

the  Regulation 

Article  2 

Definitions 

For  the  purpose  of  this  Directive,  the  terms 
used  shall  have the  following  meanings: 

(a)  "Chemical  agent"  means  any  chemical 
element  or  compound,  on  its  own  or 
admixed,  as  it  occurs  in  the  natural 
state  or  as  produced,  used  or  released, 
including  release as waste, by any  work 
activity,  whether  or  not  produced 
intentionally  and  whether  or  not  placed 
on  the  market; 

(b)  "Hazardous chemical  agent"  means: 

(i)  any  chemical  agent  which  meets 
the  criteria  for  classification  as  a 
dangerous  substance according  to 
to 
the  criteria 
Directive 67/548/EEC,  whether  or 
not 
is  classified 
under  that  Directive,  other  than 

in  Annex  VI 

that  substance 

(21) 

Council  Directive 96/49/EC of 23 July  1996 on the approximation of the laws of the Member States 
with  regard to the transport of dangerous goods by rail (OJ L No 235,  17.9.1996, p. 25).  Directive as 
amended by Commission  Directive 96/87/EC 
(OJ No L 335, 24.12  1996, p. 45). 
Council  Directive 93/75/HEC of  13 September  1993 concerning minimum  requirements for vessels 
bound  for or leaving Community  ports and carrying dangerous or polluting goods (OJ No L 247, 
5.10.1993, p.  19).  Directive as last amended by Commission Directive 97/34/EC (OJ No L 158, 
17.6.1997, p. 40). 

those  substances  which  only  meet 
the  criteria  for  classification  as 
dangerous  for  the  environment; 

(ii)  any  chemical  agent  which  meets 
the  criteria  for  classification  as  a 
dangerous  preparation  within  the 
meaning  of  Directive  88/379/EEC, 
whether  or  not  that  preparation  is 
classified  under 
that  Directive, 
preparations 
those 
other 
which  only  meet  the  criteria  for 
classification  as  dangerous  for  the 
environment; 

than 

the 
criteria 
as  dangerous 

(iii)  any  chemical  agent  which,  whilst 
not  meeting 
for 
in 
classification 
accordance  with  (i)  and  (ii),  may, 
because  of  its  physico-chemical, 
toxicological 
chemical 
properties  and  the way  it is used  or 
is  present 
the  workplace, 
present  a  risk  to  the  safety  and 
health  of  workers,  including  any 
chemical 
an 
occupational  exposure  limit  value 
under  Article 3. 

assigned 

agent 

or 

in 

(c)  "Activity 

involving  chemical  agents" 
means  any  work 
in  which  chemical 
agents  arc  used,  or  are  intended  to  be 
including 
used, 
production, 
storage, 
transport  or  disposal  and  treatment,  or 
which  result from  such  work; 

handling, 

process, 

any 

in 

(d)  "Occupational  exposure 

limit  value" 
means,  unless  otherwise  specified,  the 
limit  of  the  time-weighted  average  of 
the  concentration  of  a  chemical  agent 
in the air within  the  breathing  zone  of a 
worker 
specified 
reference  period; 

relation 

to  a 

in 

11 

(e)  "Biological  limit  value"  means  the  limit 
of  the  concentration  in  the  appropriate 
relevant 
biological  medium  of 
agent,  its  metabolite,  or  an  indicator  of 
effect; 

the 

(f)  "Health 

surveillance"  means 

the 
assessment  of  an  individual  worker  to 
determine  the  state  of  health  of  that 
individual,  as  related  to  exposure  to 
specific  chemical  agents at  work; 

(g)  "Hazard"  means  the  intrinsic  property 
of  a  chemical  agent  with  the  potential 
to cause  harm; 

(h)  "Risk"  means  the  likelihood  that  the 
potential  for  harm  will  be  attained 
under 
the  conditions  of  use  and/or 
exposure. 

Article 3 

Occupational  exposure  limit  values  and 
biological  limit  values 

shall  evaluate 

1.  The  Commission 
the 
relationship  between  the  health  effects  of 
hazardous  chemical  agents  and  the  level  of 
occupational  exposure  by  means  of  an 
independent  scientific  assessment  of 
the 
latest  available  scientific  data. 

2.  On  the  basis  of  the  evaluation  described 
in  paragraph  1,  the  Commission,  after  first 
consulting 
the  Advisory  Committee  on 
Safety,  Hygiene  and  Health  Protection  at 
Work,  shall  propose  European  objectives  in 
the 
occupational 
exposure  limit  values  for  the  protection  of 
workers  from  chemical  risks,  to  be  set  at 
Community  level. 

indicative 

form 

of 

12 

These  limit  values  shall  be  established  or 
revised,  taking  into  account  the  availability 
of  measurement  techniques,  in  accordance 
with  the  procedure  laid  down  in  Article  17 
of  Directive  89/391/EEC.  Member  States 
employers' 
shall  keep  workers' 
and 
organizations 
informed  of  occupational 
exposure  limit  values  set  at  Community 
level. 

These  limit  values  shall  be  established  or 
revised,  taking  into  account  the  availability 
of  validated  measurement  techniques,  in 
accordance with the procedure laid down in 
Article  17 
89/391/EEC. 
Member  States  shall  keep  workers'  and 
of 
employers'  organizations 
indicative  occupational 
limit 
values set at Community level. 

of  Directive 

exposure 

informed 

3.  For  any  chemical  agent  for  which  an 
indicative occupational  exposure limit  value 
is  established  at Community  level,  Member 
States 
national 
establish 
occupational  exposure  limit  value,  taking 
into  account  the  Community  limit  value, 
determining  its  nature  in  accordance  with 
national  legislation and practice. 

shall 

a 

to 

the 

in  addition 

limit 
4.  Binding  occupational  exposure 
values  may  be  drawn  up  at  Community 
factors 
level  and, 
considered  when  establishing 
indicative 
occupational  exposure  limit  values,  shall 
reflect  feasibility  factors  while  maintaining 
the aim of ensuring the health of workers at 
work.  Such limit values shall be established 
in  accordance  with  Article  118a  of  the 
Treaty  and  laid  down  in  Annex  I  to  this 
Directive. 

5  For  any  chemical  agent  for  which  a 
binding occupational  exposure  limit  value is 
established,  Member  States shall  establish a 
corresponding 
binding 
occupational  exposure  limit value based on, 
but  not  exceeding,  the  Community  limit 
value. 

national 

6.  Binding  biological  limit  values  may  be 
drawn  up  at  Community  level  on  the  basis 
of  the  evaluation  described  in  paragraph 1 
and  of  the  availability  of  measurement 
feasibility 
techniques,  and  shall  reflect 
the  aim  of 
factors  while  maintaining 
ensuring  the  health  of  workers  at  work. 

13 

Such  limit  values  shall  be  established  in 
accordance  with the procedure  laid down in 
Article  118a of the Treaty  and laid  down in 
Annex  II  to  this  Directive,  together  with 
other 
surveillance 
information. 

relevant 

health 

7.  For  any  chemical  agent  for  which  a 
binding  biological  limit  value  is  established, 
Member 
a 
corresponding  national  binding  biological 
limit value based  on,  but  not  exceeding,  the 
Community  limit value. 

establish 

States 

shall 

8.  Where  a  Member  State  introduces  or 
revises  a  national  occupational  exposure 
limit  value  or  a  national  biological  limit 
value  for  a  chemical  agent  on  the  basis  of 
new  data,  it  shall  inform  the  Commission 
and  other  Member  States  thereof  together 
with  the  relevant  scientific  and  technical 
data.  The  Commission  shall  undertake  the 
appropriate action. 

8.  Where a Member State introduces or, on 
the  basis  of  new  data,  revises  a  national 
limit  value  or  a 
occupational  exposure 
national  biological 
for  a 
the 
it 
chemical 
Commission  and  other  Member  States 
thereof together  with  the  relevant  scientific 
and  technical  data.  The  Commission  shall 
undertake the appropriate action. 

limit  value 

inform 

agent, 

shall 

8a.  On  the  basis  of  the  reports  provided 
by  the  Member  States  under  Article  15 the 
Commission  shall  carry  out  an  assessment 
of  the  way  in  which  Member  States  have 
indicative 
taken  account  of  Community 
lim i t_  values  when 
the 
corresponding 
occupational 
national 
exposure  limit  values.  If  this  assessment 
reveals  wide  differences  in  standards  the 
Commission  shall  undertake  appropriate 
action  with  a view  to  closer  harmonization 
in this area. 

establishing 

for 

methods 

9.  Standardized 
the 
measurement  and  evaluation  of  workplace 
to 
air 
occupational  exposure  limit  values  shall  be 
developed  in accordance  with Article  12(2). 

concentrations 

relation 

in 

14 

SECTION  II 
EMPLOYERS' OBLIGATIONS 

A Hide 4 

Determination  and assessment of risk of 
hazardous chemical  agents 

the  employer  shall 

I.  En carrying out the obligations laid down 
in  Articles  6(3)  and  9(1)  of  Directive 
89/391/EEC, 
first 
determine  whether  any hazardous  chemical 
agents are present  at the workplace.  If so, 
he  shall then  assess  any  risk  to  the  safety 
and  health  of  workers  arising  from  the 
presence  of  those  chemical  agents,  taking 
into consideration the following: 

- 

their hazardous properties; 

- 

information  on  safety  and  health  that 
shall  be  provided  by  the  supplier,  (e.g. 
in 
the  relevant 
the  provisions  of 
accordance  with 
Directive 
or 
Directive 88/379/EEC); 

safety  data  sheet 

67/548/EEC 

- 

the level, type and duration of exposure; 

- 

the  circumstances  of  work  involving 
such agents, including their amount; 

-  any  occupational  exposure  limit  values 
or  biological  limit  values established  on 
the  territory  of  the  Member  State  in 
question; 

- 

the  effect  of  preventive  measures  taken 
or to be taken; 

-  where  available,  the  conclusions  to  be 
drawn  from  any  health  surveillance 
already undertaken. 

I.s 

shall  obtain 

The  employer 
additional 
information  which  is  needed  for  the  risk 
assessment  from  the  supplier  or  from  other 
Where 
readily 
appropriate,  this  information  shall  comprise 
the  specific  assessment  concerning  the  risk 
the  basis  of 
to  users  established  on 
Community  legislation  on chemical  agents. 

available 

sources. 

2.  The  employer  must  be  in  possession  of 
an  assessment  of  the  risk  in  accordance 
with  Article  9  of  Directive  89/391/EEC, 
and  shall  identify  which  measures  have been 
taken  in  accordance  with  Articles  5  and  6 
of this  Directive.  The  risk  assessment  shall 
be documented  in a suitable  form  according 
to  national 
law  and  practice,  and  may 
include  a justification  by  the  employer  that 
the  nature  and  extent  of  the  risks  related  to 
chemical  agents  make  a further  detailed  risk 
unnecessary. 
risk 
assessment 
The 
assessment 
up-to-date, 
shall  be  kept 
particularly  if  there  have  been  significant 
changes  which  could  render  it  out-of-date, 
or  when  the  results  of  health  surveillance 
show  it to  be  necessary. 

2.  The  employer  must  be  in  possession  of 
an  assessment  of  the  risk  in  accordance 
with  Article  9  of  Directive  89/391/EEC, 
and  shall  identify  which  measures  have been 
taken  in  accordance  with  Articles  5  and  6 
of this  Directive.  The  risk  assessment  shall 
be  recorded  in  a  suitable  form  according  to 
national  law  and  practice,  and  may  include 
a  justification  by  the  employer  that  the 
nature  and  extent  of  the  risks  related  to 
chemical  agents make  a further  detailed  risk 
unnecessary. 
risk 
assessment 
The 
assessment 
up-to-date, 
shall  be  kept 
particularly  if  there  have  been  significant 
changes  which  could  render  it  out-of-date, 
or  when  the  results  of  health  surveillance 
show  it to be  necessary. 

3.  Certain  activities  within  the  undertaking 
or  establishment,  such  as  maintenance,  in 
respect  of  which  it  is  foreseeable  that  there 
is  a  potential  for  significant  exposure,  or 
which  may  result  in  deleterious  effects  to 
safety  and  health  for  other  reasons,  even 
technical  measures  have  been 
after  all 
risk 
taken, 
assessment. 

shall  be 

included 

the 

in 

the  case  of  activities 

4.  In 
involving 
to  several  hazardous  chemical 
exposure 
agents,  the  risk  shall  be  assessed  on  the 
basis  of  the  risk  presented  by  all  such 
chemical  agents  in  combination. 

16 

5.  In  the  case  of  a  new  activity  involving 
hazardous chemical  agents, work  shall only 
commence  after  an  assessment  of  the  risk 
of  that  activity  has  been  made  and  any 
preventive  measures  identified  have  been 
implemented. 

6.  Practical guidelines for the determination 
and assessment of risk, and for their review 
and, 
if  necessary,  adjustment,  shall  be 
developed  in accordance with Article  12(2). 

Article 5 

General principles for prevention of 
risks associated with hazardous chemical 
agents and application of this Directive 
in relation to assessment of risks 

1.  In carrying  out  his  obligation  to  ensure 
the  health  and  safety  of  workers  in  any 
involving  hazardous  chemical 
activity 
the 
the  employer 
agents 
necessary  preventive  measures  set  out  in 
of 
Article 6(1) 
the 
Directive 89/391/EEC  and 
measures set out in this Directive. 

and (2) 

include 

shall 

take 

2.  Risks to the health and safety  of workers 
involving  hazardous  chemical 
at  work 
agents  shall  be  eliminated  or  reduced  to  a 
minimum by: 

- 

- 

the  design  and  organization  of  systems 
of work at the workplace; 

the  provision  of  suitable  equipment  for 
work  with 
and 
chemical 
maintenance  procedures  which  ensure 
the  health  and  safety  of  workers  at 
work; 

agents 

17 

3.  Where  the  results  of  the  assessment 
referred  to  in  Article 4(1)  reveal  a  risk  to 
the  safety  and  health  of  workers,  the 
and 
specific 
monitoring  measures 
in 
Articles 6,  7 and  10 shall be applied. 

prevention 
laid 

protection, 

down 

-  reducing  to  a  minimum  the  number  of 
to  be 

likely 

workers  exposed  or 
exposed; 

-  reducing  to  a minimum  the  duration  and 

intensity of exposure; 

-  appropriate hygiene measures; 

-  reducing  the  quantity  of chemical  agents 
present at the workplace to the minimum 
required for the type of work  concerned; 

for 
transport  within 

suitable  working  procedures  including 
the  safe  handling, 
arrangements 
the 
and 
storage 
workplace  of  hazardous  chemical  agents 
and  waste  containing  such  chemical 
agents. 

Practical guidelines for preventive  measures 
to  control  risk  shall  be  developed 
in 
accordance with Article  12(2). 

3.  Where  the  results  of  the  assessment 
referred  to  in  Article 4(1)  reveal  a  risk  to 
the  safety  and  health  of  workers,  the 
specific  protection,  prevention,  monitoring 
and  information  measures  laid  down  in 
Articles 6,  7,  8 and  10 shall be applied. 

4.  Where  the  results  of  the  risk  assessment 
in  Article  4(1)  show  that, 
referred  to 
because  of  the  quantities  of  a  hazardous 
chemical  agent  present  in  the  workplace, 
there  is  only  a  slight  risk  to  the  safety  and 
health  of  workers,  and  the  measures  taken 
in  accordance  with  paragraphs  1  and  2  of 
this  Article  are  sufficient  to  reduce  that 
risk,  the  provisions  of  Articles 6,  7  and  10 
shall not apply. 

18 

Article  6 

Specific  protection  and  prevention 
measures 

1.  The  employer  shall  ensure  that  the  risk 
from  a  hazardous  chemical  agent  to  the 
safety  and  health  of  workers  at  work  is 
eliminated or reduced to a minimum. 

2.  In  applying  paragraph  1,  substitution 
shall  by  preference  be  undertaken,  whereby 
the  employer  shall  avoid  the  use  of  a 
hazardous  chemical  agent  by  replacing  it 
with  a  chemical  agent  or  process  which, 
under its condition  of  use,  is  not  hazardous 
or  is  less  hazardous  to  workers'  safety  and 
health, as the case may be 

Where  the  nature  of  the  activity  does  not 
permit  risk  to  be eliminated  by substitution, 
having  regard  to  the  activity  and  risk 
assessment  referred  to  in  Article 4,  the 
employer  shall  ensure  that  the  risk 
is 
reduced  to  a  minimum  by  application  of 
protection 
prevention  measures, 
consistent  with  the  assessment  of  the  risk 
made  pursuant  to  Article 4.  These  will 
include,  in order of priority: 

and 

(a)  design  of  appropriate  work  processes 
and  engineering  controls  and  use  of 
adequate  equipment  and  materials,  so 
as  to  avoid  or  minimize  the  release  of 
hazardous  chemical  agents  which  may 
present  a  risk  to  workers'  safety  and 
health at the place of work; 

(b)  application  of  collective  protection 
measures at the source of the risk,  such 
as adequate ventilation  and appropriate 
organizational  measures; 

(c)  where  exposure  cannot  be  prevented 
of 
measures 
protective 

protection 
personal 

other  means, 

application 

by 
individual 
including 
equipment. 

Practical  guidelines 
for  protection  and 
prevention  measures  to  control  risk  shall  be 
developed  in accordance  with  Article  12(2). 

3.  The  measures  referred  to  in  paragraph  2 
of  this  Article  shall  be  accompanied  by 
in  accordance  with 
health  surveillance 
Article  10  if  it  is  appropriate  to  the  nature 
of the  risk. 

the 

employer 

clearly 
4.  Unless 
demonstrates  by  other  means  of  evaluation 
that, 
in  accordance  with  paragraph  2, 
adequate  prevention  and  protection  have 
been  achieved,  the  employer  shall  carry  out 
on  a  regular  basis,  and  when  any  change 
occurs  in  the  conditions  which  may  affect 
workers'  exposure  to  chemical  agents,  such 
measurements  of  chemical  agents  which 
may  present  a  risk  to  workers'  health  at  the 
workplace  as  are  necessary,  in  particular  in 
relation  to  the  occupational  exposure  limit 
values. 

5.  The  employer  shall  take  into  account  the 
results  of  the  procedures  referred 
to  in 
paragraph  4  of  this  Article  in  carrying  out 
the  obligations  laid  down  in  or  resulting  as 
a consequence  of Article 4. 

In  any  event,  where  an  occupational 
exposure  limit  value  ellectively  established 
on  the territory  of a  Member  State  has been 
exceeded,  the  employer  shall  immediately 
take  steps, taking  into account  the  nature  of 
that 
the  situation  by 
carrying  out  preventive  and  protective 
measures. 

to  remedy 

limit, 

20 

technical 

6.  On  the  basis  of  the  overall  assessment  of 
and  general  principles  for  the  prevention  of 
risks  in  Articles  4  and  5,  the  employer  shall 
take 
organizational 
and/or 
measures  appropriate  to  the  nature  of  the 
operation,  including  storage,  handling  and 
segregation 
chemical 
agents,  providing  protection  of  workers 
against  hazards  arising  from  the  physico-
chemical  properties  of  chemical  agents.  In 
particular  he  shall  take  measures,  in  order 
of priority,  to: 

incompatible 

of 

technical 

6.  On  the basis  of the  overall  assessment  of 
and  general  principles  for  the  prevention  of 
risks  in  Articles  4  and  5,  the  employer  shall 
take 
organizational 
and/or 
measures  appropriate  to  the  nature  of  the 
operation,  including  storage  and  handling, 
providing  protection  of  workers  against 
hazards  arising  from  the  physico-chemical 
properties  of  chemical  agents.  In  particular 
he  shall  take  measures,  in  order  of  priority, 
to 

hazardous 

concentrations 

(a)  prevent  the  presence  at  the  workplace 
of 
of 
inflammable  substances  or  hazardous 
quantities 
unstable 
substances  or,  where  the  nature  of  the 
work  does  not  allow  that, 

chemically 

of 

(b)  avoid  the  presence  of  ignition  sources 
which  could  give  rise  to  fires  and 
conditions 
explosions,  or 
which  could  cause  chemically  unstable 
substances  or  mixtures of substances  to 
give  rise  to  harmful  physical  effects, 
and 

adverse 

(c)  mitigate  the  detrimental  effects  to  the 
health  and  safety  of  workers  in  the 
event  of  fire  or  explosion  due  to  the 
ignition  of  inflammable  substances,  or 
harmful  physical  effects  arising  from 
substances  or 
chemically  unstable 
mixtures  of substances. 

Work  equipment  and  protective  systems 
provided  by the employer  for  the  protection 
of  workers  shall  comply  with  the  relevant 
design, 
Community 
provisions 
to 
manufacture  and  supply  with  respect 
and/or 
health  and 
organizational  measures 
the 
employer  shall  take  account  of  and  be 
group 
the 
consistent  with 

taken  by 

equipment 

Technical 

safety. 

on 

21 

I  to  Directive 
in  Annex 
categorization 
94/9/EC  of  the  European  Parliament  and  of 
the  Council  of  23  March  1994  on 
the 
approximation  of  the  laws  of  the  Member 
States  concerning  equipment  and  protective 
systems 
in  potentially 
intended 
explosive  atmospheres  (23). 

for  use 

sufficient 

take  measures 
control 

to 
The  employer  shall 
provide 
plant, 
equipment  and  machinery  or  provision  of 
or 
equipment 
suppression 
explosion 
explosion  pressure  relief arrangements. 

of 

Article 7 

Arrangements  to  deal  with  accidents, 
incidents  and  emergencies 

I.  Without  prejudice  to  the  obligations  laid 
down  in Article  8 of  Directive  89/391/EEC, 
the  employer  shall,  in  order  to  protect  the 
safety  and  health  of  workers  from  an 
accident,  incident  or  emergency  related  to 
the  presence  of  hazardous  chemical  agents 
at 
the  workplace,  establish  procedures 
(action  plans)  which  can  be  put  into  effect 
when  any  such  event  occurs,  so 
that 
These 
action 
appropriate 
is 
arrangements  shall 
include  any  relevant 
safety  drills  which  are  to  be  performed  at 
regular 
the  provision  of 
appropriate  first  aid  facilities. 

intervals,  and 

taken. 

2.  In  the  case of the occurrence  of an  event 
such  as  is  mentioned  in  paragraph  1,  the 
employer  shall  immediately  take  steps  to 
mitigate  the  effects  of  the  event  and  to 
inform  the workers  concerned  thereof. 

In order to  restore  the situation  to  normal: 

- 

employer 
the 
appropriate  measures 
situation  as soon  as possible; 

shall 
to 

implement 
the 

remedy 

)i  No !,  100, 19.4. i 994, p. 1. 

22 

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

3.  The  workers  who  are  permitted  to  work 
in  the  affected  area  shall  be  provided  with 
appropriate  protective  clothing,  personal 
protective  equipment,  specialized 
safety 
equipment  and  plant  which  they must  use  as 
long  as  the  situation  persists;  that  situation 
shall  not be  permanent. 

Unprotected  persons  shall  not  be  permitted 
to  remain  in the aflectcd  area 

prejudice 

to  Article  8  of 
4.  Without 
Directive  89/391/EEC  the  employer  shall 
take  the  measures  necessary  to  provide  the 
warning  and  other  communication  systems 
required  to  signal  an  increased  risk  to  safety 
and  health, 
to  enable  an  appropriate 
response  and  to  launch  remedial  actions, 
assistance,  escape  and  rescue  operations 
immediately  if the need  arises. 

shall 

ensure 

employer 

that 
5.  The 
information  on  emergency  arrangements 
involving  hazardous  chemical  agents 
is 
available. 
internal  and 
external  accident  and  emergency  services 
shall  have  access  to  this  information. 
It 
shall  include  the  following: 

relevant 

The 

identification 

-  advance  notice of relevant  work  hazards, 
hazard 
arrangements, 
precautions  and  procedures,  so  that  the 
their 
emergency  services  can  prepare 
own 
and 
response 
precautionary  measures; and 

procedures 

23 

any  available  information  concerning 
specific  hazards  arising,  or  likely  to 
arise,  al  the  time  of  an  accident  or 
emergency,  including  information  on 
procedures  prepared  pursuant  to  this 
Article. 

Article 8 

Information  for  workers 

Information and training for workers 

3.  Without  prejudice 
to  Article  30  of 
Directive  89/391/EEC  the  employer  shall 
ensure 
their 
thai  workers 
representatives are provided with: 

and/or 

3.  Without  prejudice  to Articles  10 and  12 
of  Directive  89/391/EEC  the  employer 
shall  ensure  that  workers  and/or 
their 
representatives are provided with: 

- 

the  data  obtained  pursuant  to  Article 4 
of  this  Directive,  and  further  informed 
whenever  a  major  alteration  at  the 
workplace  leads  to  a  change  in  these 
data; 

information  on  hazardous  chemical 
agents,  such  as  the  identity  of  such 
agents,  the  risks  to  safety  and  health, 
relevant  occupational  exposure 
limit 
values and other legislative provisions; 

information  on  the  hazardous  chemical 
agents  in  the  workplace  and  hazardous 
chemical  agents  identified  in  the  risk 
assessment  made  pursuant  to  Article 
4( 1 ) such  as the identity of these agents, 
the  risks  to  safety  and  health,  relevant 
occupational  exposure  limit  values  and 
other legislative provisions; 

- 

information  on  appropriate  precautions 
and  actions  to  be  taken  in  order  to 
safeguard  themselves  and  other workers 
at the workplace; 

training  and  information  on  appropriate 
precautions  and  actions  to  be  taken  in 
order to safeguard  themselves  and  other 
workers at the workplace; 

the  supplier 

access  to any safely  dala sheet  provided 
by 
in  accordance  with 
Article  10 of  Directive  88/379/EEC and 
Article 27 of Directive 92/32/EEC "',); 

And that the information  is: 

OJNoI,  154, 5.6.1992, p. 1. 

24 

from  oral 

provided  in a  manner  appropriate  to  the 
outcome  of the  risk  assessment  pursuant 
to  Article 4  of  this  Directive.  This  may 
vary 
to 
training 
individual 
supported  by 
in  writing, 
depending  on  the  nature  and  degree  of 
the  risk  revealed  by  the  assessment 
required by the said Article; 

communication 
and 

information 

instruction 

-  updated  to  take  account  of  changing 

circumstances. 

containers 

and  pipes 

for 
2.  Where 
hazardous chemical agents used at work  are 
not  marked in accordance  with  the  relevant 
Community  legislation  on  the  labelling  of 
chemical  agents  and  on  safety  signs  at  the 
workplace,  the  employer  shall,  without 
prejudice to the derogations  provided  for in 
the above mentioned legislation,  ensure that 
the  contents  of  the  containers  and  pipes, 
together  with  the  nature  of  those  contents 
and  any  associated  hazards,  are  clearly 
identifiable. 

3.  Member  States  may 
take  measures 
necessary  to  ensure  that  employers  may, 
preferably  from  the  producer  or  supplier, 
obtain  on  request  all 
information  on 
hazardous  chemical  agents  needed  to  apply 
Article 4(1)  of  this  Directive,  insofar  as 
Directives 67/548/EEC  and 88/379/EEC  do 
not 
to  provide 
information. 

include  any  obligation 

2.S 

SECTION  m 
M I S C E L L A N E O US  PROVISIONS 

Article  9 

Prohibitions 

1.  To  prevent  the  exposure  of  workers  to 
health  risks  from  certain  chemical  agents 
and/or  certain  activities  involving  chemical 
agents,  the  production,  manufacture  or  use 
at  work  of  the  chemical  agents  and  the 
in  Annex  III  shall  be 
activities  set  out 
prohibited  to the extent  specified  therein. 

2.  Member  States  may  permit  derogations 
from  the  requirements  of paragraph  1 in  the 
following  circumstances: 

- 

- 

the 

for 
sole  purpose  of 
research  and  testing,  including  analysis; 

scientific 

eliminate 
intended 
for  activities 
chemical  agents  that  are  present  in  the 
form  of by-products  or  waste  products; 

to 

the  production  of 

for 
the  chemical 
agents  referred  to  in  paragraph  1 for  use 
as intermediates,  and  for  such  use. 

The  exposure  of  workers 
to  chemical 
agents  referred  to  in  paragraph  1  must  be 
prevented,  in  particular  by  providing  that 
the  production  and  earliest  possible  use  of 
such  chemical  agents  as  intermediates  must 
take  place  in  a  single  closed  system,  from 
which  the aforesaid  chemical  agents  may  be 
removed  only  to  the  extent  necessary  to 
monitor  the  process  or  service the  system. 

Member  States  may  provide  for  systems  of 
individual  authorizations. 

26 

derogations 

3.  When 
permitted 
pursuant  to  paragraph  2,  the  competent 
authority  shall  request  the  employer  to 
submit the following  information: 

are 

- 

the reason for requesting the derogation; 

- 

the  quantity  of  the  chemical  agent  to  be 
used annually; 

the  activities 
processes  involved; 

and/or 

reactions  or 

- 

the  number  of  workers 
involved; 

liable  to  be 

- 

- 

the  precautions  envisaged  to  protect  the 
safety and health of workers concerned; 

technical 

the 
organizational 
and 
measures  taken  to  prevent  the  exposure 
of workers. 

4.  The  Council,  in  accordance  with  the 
procedure  laid  down  in  Article  118a  of  the 
Treaty,  may  amend  the  list  of  prohibitions 
under paragraph  I of this Article,  to  include 
further chemical agents or activities. 

27 

A Hide  10 

Health  Surveillance 

I.  Without  prejudice 
to  Article  14  of 
Directive  89/391 /EEC,  Member  States  shall 
introduce  arrangements  for  carrying  out 
appropriate  health  surveillance  of  workers 
for  whom  the  results  of  the  assessment 
referred  to  in  Article 4  of  this  Directive 
reveal 
These 
to 
arrangements,  including  the  requirements 
specified  for  health  and  exposure  records 
and  their  availability,  shall  be  introduced  in 
accordance  with  national 
laws  and/or 
practice 

health. 

risk 

a 

Health  surveillance,  the  results  of  which 
in  applying 
shall  be  taken  into  account 
specific 
preventive  measures 
workplace,  shall be appropriate  where: 

the 

in 

- 

the  worker 

to  a 
the  exposure  of 
hazardous  chemical  agent  is such  that  an 
identifiable  disease  or  adverse  health 
effect  may  be  related  to  the  exposure; 
and 

- 

there  is  a  likelihood  that  the  disease  or 
effect  may  occur  under  the  particular 
conditions  of the worker's  work,  and 

the  technique  of  investigation  is  of  low 
risk  to  workers. 

Furthermore,  there  shall be valid  techniques 
for  detecting  indications  of  the  disease  or 
effect. 

Health  surveillance  procedures  shall  be 
agreed  with the worker  concerned. 

28 

a 

be 

shall 

Where  a  binding  biological  limit  value  has 
been  set  as  indicated  in  Annex  II,  health 
surveillance 
compulsory 
requirement  for  work  with  the  hazardous 
chemical  agent  in  question,  in  accordance 
that  Annex. 
with 
Workers 
this 
of 
requirement  before  being  assigned  to  the 
the 
involving  risk  of  exposure 
task 
hazardous  chemical  agent  indicated. 

in 
informed 

the  procedures 

shall 

be 

to 

shall 
that 

States 
to  ensure 

2.  Member 
establish 
for  each 
arrangements 
worker  who  undergoes  health  surveillance 
in  accordance  with 
the  requirements  of 
paragraph  I,  individual  health  and  exposure 
records are made and  kept  up-to-date. 

records 

carried  out 

3.  Health  and  exposure 
shall 
contain  a  summary  of  the  results  of  health 
and  of  any 
surveillance 
monitoring  data 
the 
Biological 
exposure  of  the 
monitoring  and  related  requirements  may 
form  part  of health  surveillance. 

representative  of 
individual. 

Health  and  exposure  records  shall  be  kept 
in  a  suitable 
to  permit 
consultation  at  a  later  date,  taking  into 
account  any  confidentiality. 

so  as 

form 

Copies  of  the  appropriate  records  shall  be 
to  the  competent  authority  on 
supplied 
request.  The  individual  worker  shall,  at  his 
request,  have  access  to  the  health  and 
exposure  records relating to  him  personally. 

Where  an  undertaking  ceases  to  trade,  the 
health  and  exposure  records  shall  be  made 
available  to  the competent  authority. 

4.  Where,  as a result  of health  surveillance. 

29 

the  worker  shall  be  informed  by  the  doctor 
or  other  suitably  qualified  person  of  the 
result  which  relates  to  him  personally, 
including  information  and  advice  regarding 
any  health  surveillance  which  he  should 
undergo  following  the  end  of the  exposure, 
and 

a  worker  is  found  to  have  an  identifiable 
disease  or adverse  health  effect  which  is 
considered  by  a  doctor  or  occupational 
health-care  professional  to  be  the  result 
of  exposure  at  work  to  a  hazardous 
chemical  agent; or 

a  binding  biological  limit  value  is  found 
to have been  exceeded, 

the  worker  shall  be  informed  of  the  result 
which  relates  to  him  personally,  including 
information  and advice  regarding  any health 
surveillance  which  he  should  undergo 
following  the end of the exposure, and 

the employer shall: 

-  review 

the 

risk  assessment  made 

pursuant to Article 4( I ); 

the  measures  provided 

review 
to 
eliminate  or  reduce  risks  pursuant  to 
Articles  5 and 6; 

take  into  account  the  advice  of  the 
occupational  health-care  professional  or 
other  suitably  qualified  person  or  the 
competent  authority in implementing any 
measures  required to eliminate or reduce 
risk 
in  accordance  with  Article 6, 
including  the  possibility  of  assigning  the 
worker  to  alternative  work  where  there 
is no risk of further exposure, and 

30 

arrange  continued  health  surveillance 
and  provide  for  a  review  of  the  health 
status  of any other  worker  who  has  been 
In  such  cases  the 
similarly  exposed. 
competent 
occupational 
the 
professional 
health-care 
competent  authority  may  propose  that 
exposed  persons  undergo  a  medical 
examination 

doctor 

or 

or 

Consultation  and  participation  of  workers 
and/or  their  representatives  shall  take  place 
in  accordance  with  Article  11  of  Directive 
89/39l/EEC  on  the  matters  covered  by  this 
Directive,  including  the  Annexes  hereto. 
Workcrs  and/or  their  representatives  shall 
in  particular_bje_consulted  in  relation  to  the 
outcome  of  the  risk  assessment ..referred  to 
in  Article  4(1)  and 
the  protection  and 
prevention  measures  referred  to  in  Articles 
5 and  6. 

Article  11 

Consultation  and  participation  of 
workers 

Consultation  and  participation  of  workers 
and/or  their  representatives  shall  take  place 
in  accordance  with  Article  11  of  Directive 
89/391/EEC  on  the  matters  covered  by  this 
Directive,  including the  Annexes  hereto. 

Article  12 

Adaptation  of the Annexes,  preparation 
and  adoption  of technical  guidance 

I.  Adjustments  of a strictly  technical  nature 
to the  Annexes  in line with: 

the  adoption  of  Directives  in  the  field  of 
technical 
and 
standardisation 
chemical 
agents,  and/or 

harmonization 
concerning 

progress, 

technical 
in 
international  standards  or  specifications 
and  new  findings  concerning  chemical 
agents, 

changes 

31 

shall  be  adopted  in  accordance  with  the 
in  Article  17  of 
laid  down 
procedure 
Directive  89/391/EEC. 

2.  The Commission  shall  draw  up  practical 
guidelines  of  a  non-binding  nature.  These 
guidelines  shall  address  the  topics  referred 
to  in  Articles  3,  4,  5  and  6,  and  Annex  II, 
section  I. 

The  Commission  shall  first  consult 
the 
Advisory  Committee  on  Safely,  Hygiene 
in 
at  Work 
Protection 
and  Health 
accordance  with  Decision  74/325/EEC. 

shall 
far  as  possible  of 

In  the  context  of  the  application  of  this 
take 
Directive,  Member  States 
account  as 
these 
guidelines 
in  drawing  up  their  national 
policies  for  the  protection  of  the  health  and 
safety  of  workers. 

Article  13 

Repeal  and  amendment  of earlier 
Directives 

1.  Directives  80/1107/EEC,  82/605/EEC 
and  88/364/EEC  shall  be  repealed  on  the 
date referred  to  in  Article  14(1). 

2.  Council  Directive  83/477/EEC  of  19 
September  1983  on 
the  protection  of 
workers  from  the  risks  related  to  exposure 
individual 
to  asbestos  at  work  (second 
Directive  within  the  meaning  of  Article X 
of  Directive  SO/I 107/EEC) ('S),  is  amended 
as  follows: 

OJ  No  L 263, 24.9.1983, p. 25.  Directive  as amended  by  Directive  91/382/EEC (OJ  No  I, 206, 
29.7.1991,  p.  16). 

32 

(a) 

in  the  first  sentence  of  Article  1(1), the 
following  words  shall  be  deleted: 
individual 
the 
"which 
second 
Directive  within 
the  meaning  of 
Article  X of  Directive  80/1 107/EEC"; 

is 

(b)  Article 9(2)  shall  be  replaced  by  the 

following: 

the  procedure 

"2. 
The  amendments  necessary  to 
adapt  the  Annexes  to  this  Directive  to 
technical  progress  shall  be  adopted  in 
accordance  with 
laid 
in  Article  17  of  Council 
down 
Directive  89/391/EEC of  12 June  1989 
on  the  introduction  of  measures  to 
encourage  improvements  in  the  safety 
the 
and 
workplace. 

of  workers 

health 

at 

(c) 

the 

second 

subparagraph 

of 
in 
Article  15(1) the  words  "in  accordance 
with  the procedure  set out  in Article  10 
of  Directive  80/1 107/EEC"  shall  be 
replaced  by  "in  accordance  with  the 
procedure  laid  down  in  Article  17  of 
Directive  89/39l/EEC". 

86/188/EEC 

of 
3.  Council  Directive 
12 May  1986  on  the  protection  of  workers 
from  the  risks  related  to  exposure  to  noise 
at work  (2f,) is amended  as  follows: 

(a) 

in  Article  1(1),  the  following  words 
shall  be  deleted:  "which  is  the  third 
the 
individual  Directive  within 
meaning  of Directive  80/1107/EEC"; 

(b)  in 

Article  12(2), 

second 
subparagraph  shall  be  replaced  by  the 
following: 

the 

(26) 

OJNoL  137, 24.5.1986, p. 28. 

33 

"Annexes  I  and  II  shall  be  adapted  to 
technical  progress  in  accordance  with 
the  procedure  laid  down  in  Article  17 
of Council  Directive  89/391/EEC  of  12 
June  1989  on 
introduction  of 
the 
measures  to  encourage  improvements 
in  the  safety  and  health  of  workers  at 
the  workplace. 

in  Directive 
reference 
4.  Any  other 
83/477/EEC  and  Directive  86/188/EEC  to 
Directive  80/1107/EEC  shall  be  obsolete 
the  said 
from 
Directive 

the  date  of 

repeal  of 

5.  Directives  91/322/EEC  and  96/94/EC 
remain  in  force. 

SECTION  IV 
Final  provisions 

Article  14 

and 

regulations 

1.  Member  States  shall  bring  into  force  the 
laws, 
administrative 
provisions  necessary  to  comply  with  this 
](  '.  They 
Directive  not  later  than  [ 
shall 
the  Commission 
inform 
thereof. 

forthwith 

adopt 

States 

When  Member 
these 
measures,  they  shall  contain  a  reference  to 
this  Directive  or  shall  be  accompanied  by 
such  reference  on  the  occasion  of  their 
official  publication. 
for 
making such  reference  shall be laid down  by 
Member  States. 

The  methods 

2.  Member  States  shall  communicate  to  the 
Commission  the  texts  of  the  provisions  of 
they  have  already 
national 
adopted  or  which  they  adopt  in  the  field 
governed  by this  Directive. 

law  which 

Three years aller publication  of this Directive in the Official  Journal of the European Communities. 

34 

Article  15 

shall 

to 
report 
five  years  on 

the 
Member  States 
Commission  every 
the 
practical  implementation  of  this  Directive, 
indicating  the  views  of  employers  and 
workers. 

The Commission  shall  inform  the  European 
Parliament,  the  Council  and  the  Economic 
and Social  Committee  thereof. 

Article  16 

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

that  of 

Article  17 

This  Directive  is  addressed  to  the  Member 
States. 

Done a I 

For the Council 

The President 

35 

ANNEX 1 

List  of binding occupational  exposure  limit  values 

Name ol" 

agent 

KINKCS 
( ' ) No 

CAS 
(2)  No 

()ccu pat i ona 1 exposu re 
limit  value  8 h (') 

Inorganic 
lead and its 
compounds 

mg/m' 

0,15 

pom 
O 

Occupational 
exposure  limit  value 
Short-term  f/) 

mg/m* 

ppm 

(')  EÎNECS:  European  Inventory of Existing Commercial  Chemical  Substances 
(2)  CAS:  Chemical  Abstracts Service 
C)  Measured or calculated  in relation  to a reference period of 8 hours, 

limc-wcightcd average 

C1)  A limit value above which exposure should  not occur, and which is related to 

a  15 minute period  uniess otherwise  specified 

C)  jiig/ni"*  =  milligrams per cubic metre of air at 20° C and  101,3 KPa 
(6)  ppm  =  parts per million  by volume in air (ml/m3) 

36 

ANNEX  H 

Binding biological  limit values and health surveillance 

measures 

I. 

Lead and its ionic  compounds 

1.1.  Biological  monitoring  must  include  measuring  the 
blood-lead 
absorption 
(PbB) 
spectrometry  or  a  method  giving  equivalent 
results.  The binding biological  limit value is: 

using 

level 

70ugPb/100mlblood 

1.2.  Medical  surveillance is carried out  if: 

exposure  to  a concentration  of  lead  in  air  is 
greater  than  0,075  mg/m3,  calculated  as  a 
time-weighted  average  over  40  hours  per 
week,  or 

blood-lead 

level 
a 
40  pg Pb/100 ml  blood 
individual workers. 

greater 
is  measured 

than 
in 

surveillance  must  be  developed 

1.3.  Practical  guidelines  for  biological  monitoring  and 
in 
medical 
accordance  with  Article  12(2). 
These  must 
include  recommendations  of  biological  indicators 
(e.g.  ALAU,  ZPP,  ALAD)  and  biological 
monitoring strategies. 

37 

ANNEX 111 

Prohibitions 

The  production,  manufacture  or  use  at  work  of the 
chemical  agents and activities  involving chemical  agents 
set out below  are prohibited.  The  prohibition  does not 
apply if the chemical agent is present in another chemical 
agent,  or  as a  constituent  of waste,  provided  that  its 
individual  concentration  therein  is  less  than  the  limit 
specified. 

(a) Chemical Agents 

EINECS (') No 

CAS (2) No 

Name of agent 

202-080-4 

91-59-8 

201-177-1 

92-67-1 

202-199-1 

92-87-5 

2-naphthylaminc 
and its salts 

4- aminodiphenyl 
and its salts 

Benzidine and its 
salts 

Concentration 
Limit for 
exemption 

0,l%w/w 

0.1%w/w 

0,l%w/w 

202-204-7 

92-93-3 

4-nitrodiphenyl 

0.1%w/w 

(')  EINECS: European  Inventory of Existing Commercial  Chemical 

Substances 

(2) 

CAS: Chemical  Abstracts Service 

(b) Work Activities 

None. 

28 

The  Commission  is unable  to  accept  the  following  amendments  proposed  bv the 
European  Parliament 

1.  part of Amendment N° 5 (concerning Article 4.2) 

This part  of the amendment  requires employers to  record  the risk assessment  in a 
suitable  form  taking  into account  national  law  and  practice.  This would  certainly 
weaken the common  position which requires the records to be made according to 
national law and practice, that is with full  respect of the national law. 

2.  Amendment N° 8 (concerning Article 6.5) 

The  amendment  requires  the  employers  always  to  adhere  to  the  occupational 
exposure  limit  value,  irrespective  of  the  nature  of  the  national  provision.  The 
Commission  considers  that  this  amendment  would  undermine  the  distinction 
between indicative and binding limit value. 

3.  Amendment N°  14 (concerning Article  12,  1, second indent) 

This  amendment  requires  deletion  of  "new findings" among  situations  requiring 
technical  adjustments  of  Annexes.  The  Commission  believes  that  "new findings" 
are  indeed  one  of  the  main  reasons  behind  a  need  for  technical  changes.  The 
procedure  presented  in the  common  position  gives the  Community  the possibility 
to  react  rapidly  with  technical  solutions  to  "new  findings";  the  use  of  this 
procedure is limited to strictly technical  adjustments. 

3.1 

ISSN 0254-1475 

COM(98)  162 final 

DOCUMENTS 

EN 

04  05  15 

Catalogue number  :  CB-C0-98-161-EN-C 

ISBN 92-78-32043-9 

Office  for Official  Publications of the European  Communities 

L-2985 Luxembourg