Proposal for a COUNCIL DIRECTIVE on the protection of the health and safety of workers from the risks related to chemical agents at work
Date: 1993-05-14
Institutions: European Commission
Subjects: accident prevention, chemical product, dangerous substance, environmental risk prevention, occupational health, occupational safety

COMMISSION  OF THE EUROPEAN  COMMUNITIES 

C0M(93) 155 final - SYN 459 

Brussels, 14 May 1993 

Proposal for a 

COUNCIL DIRECTIVE 

on the protection of the health and safety of workers from the 

risks related to chemical agents at work 

(presented by the Commission) 

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EXPLANATORY  MEMORANDUM 

Legal base 

1. 

This proposal is  based  on  Article  118A of  the EEC Treaty  and  is  presented 

in  the  form  of  an  individual  Directive  under  Article  16  of  Council  Directive 

89/391/EEC  "on  the  introduction  of  measures  to  encourage  improvements  in  the 

health and safety at work" 0). 

Justification  for this proposal 

a) 

Reason for Community action 

2. 

Exposure  to  chemical  agents  occurs  in  every  aspect  of  daily  life.  Over 

100,000  chemicals  are  included  in  the  European  Inventory  of  Existing  Chemical 

Substances  (EINECS).  Many  of  these  chemicals  have dangerous  properties  which 

can adversely affect  the health and safety  of  workers at work.  It has been estimated 

that  accidents  and  ill  health  at  work  account  for  approximately  7%  of  all  social 

security  expenditure  within  the  EC,  affecting  10  million  workers  every  year  at an 

overall cost of 20 billion ECU.  It is clear from information  in Member States that a 

significant  proportion  of  the  ill-health  that  is  caused  by  work  activities  is  due  to 

(0 

O J. N' L183 of 29.06.1989, p. 1 

exposure  to  chemical  agents. 

It  is  therefore  important  that  suitable  precautions 

should be taken at the workplace to prevent these problems. 

3. 

In  Member  States  the  legal  provisions  concerning  protection  of  workers 

against  the risks related  to  chemical  agents  are divergent.  In  some  cases  they  are 

rudimentary and in others they are comprehensive;  some are more stringent than the 

present proposal  which is  designed  to ensure  that all  Member  States come  up to at 

least  the  minimum  level  considered  necessary.  In  line  with  Article  118A  of  the 

EEC  Treaty  the  proposal  is  couched  in  general  terms  with  general  principles 

covering  all  chemical  agents.  This  is  because  it  is  the  most  cost-effective  way  of 

providing  a general  framework,  which  will  avoid the need  for  specific  Community 

provisions for many individual chemicals on a case-by-case basis. 

b) 

Subsidiarity. 

4. 

The proposal does not breach the principle of  subsidiarity,  because it is  only 

by Community action that a minimum level of protection for workers from  the risks 

related  to exposure  to chemical  agents  can be assured  in all  Member States.  Such 

action will also avoid any distortion in the area of competitiveness by preventing  the 

unequal  application  of  minimum  standards  for  worker  protection  in  one  or  other 

Member States. 

5. 

Moreover  this  proposal  will  encourage  more  flexibility  in  cross  border 

employment  because  workers  can  be  reassured  that  they  will  find  at  least  the 

minimum  level  of  protection  of  their  health  and  safety  in  all  Member  States. 

Employers  will  also  be  reassured  that  the  costs  of  production  will  not  be  unduely 

distorted as a result of differences  in the levels  of  protection  of  health and  safety  at 

work. 

6. 

The  current  proposal  responds  to  the  above  needs.  It  is  also  one  of  the 

actions  aimed  at  achieving  the  social  dimension  of  the  internal  market.  The  text 

includes  measures  relating  to  information  on  dangerous  chemical  agents  as 

specifically  referred to in the programme on the Community Charter of Basic Social 

Rights for  workers.  Information  is one of  the pillars  on  which  effective  health and 

safety  practices  are  built;  it  forms  an  integral  part  of  this  text  and  aligns 

requirements  for  the labelling  of  containers  for  chemicals  at work with the  existing 

labelling  requirements  that apply  for the purpose of  placing  chemical  agents  on  the 

market. 

7. 

The  objectives  outlined  above  involve  a  number  of  different  areas  of 

Community  policy. 

It  is  unlikely  that  they  can  be  achieved  by  Member  States 

acting  individually  therefore  it  is  necessary  that  a  co-ordinated  action  is  taken  at 

Community  level. 

c) 

Proportionality 

8. 

Community  provisions  have  to be  framed  in  such  a  way  that  they  meet  the 

requirements  for  acceptable  minimum  standards  of  health  and  safety  without 

imposing  an  undue burden  on  employers;  in  particular  they  must  avoid  constraints 

which  would  hold  back  the  creation  and  development  of  small  and  medium-sized 

enterprises.  The present proposal is believed  to achieve those two requirements. 

9. 

In the first place  the proposal  is  an amplification  of  the requirements  of  the 

Framework  Directive  89/391/EEC  on  the  introduction  of  measures  to  encourage 

improvements  in  the safety  and health of  workers  at work  rather  than a  set  of  new 

and  unrelated  measures.  Requirements  on  employers  under  this  proposal  are 

therefore based on an assessment of risks made by  the employer in accordance with 

Article  6 (3)  of  Directive  89/391/EEC.  The  measures  to be  taken are therefore  in 

proportion  to  the risks incurred  from  the chemical  agents  being  used  at  work.  In 

the same  sense  that the  text  is  an  amplification  of  Directive  89/391/EEC  the  more 

specific  requirements  of  this  text  in  fact  render  the  framework  of  Directive 

89/391/EEC less onerous,  by the provision of guidance on its application. 

10. 

The  proposal  as  it  stands  covers  all  chemical  agents  without  prejudging 

whether or not they are hazardous.  This is important because even chemical  agents 

that are  nominally  harmless  may  interact  with  others  to  create  or  enhance  a risk. 

Chemical  agents  not  normally  considered  hazardous  in  daily  life  may  also  be 

hazardous when used in larger quantities at the workplace.  For example sand is not 

hazardous  unless  it  is  ground  to a fine powder when it can cause  lung  disease  such 

as  has  occured  in  foundries  and  potteries.  Also  hazardous  interaction  may  occur 

involving  chemicals  that are nominally  harmless on  their own.  For example  water 

may  react violently  with  other  chemicals  such  as  strong  acids  or  metals;  it  is  only 

when the combination of the water and the other chemical occurs together that a  risk 

exists. 

Therefore  it  is  only  by  taking  into  account  the  combined  action  of  all  chemical 

agents  that  a  proper  assessment  can  be  made  and  the  correct  measures  taken  to 

protect workers. 

If  it  can  be  shown  that  for  any  particular  chemical  there  are  no  foreseeable  risks 

from  the  chemical  or  its  interaction  then  no  further  action  is  required  once  the 

assessment has been completed. 

11. 

In amplifying  the requirements of Directive 89/391/EEC care has been taken 

to cast  the proposals  in  terms  of  objectives  to  be achieved,  rather  than  as  detailed 

and  prescriptive  requirements. 

The  employer  is  given  maximum  flexibility  in 

deciding  how  best  to  achieve  the  objectives  for  any  of  the  100,000  or  more 

industrial chemical agents that may be relevant in his particular circumstances.  It is 

only  in cases  of  particularly  dangerous  chemical  agents  e.g.  for  materials  that may 

be carcinogenic,  mutagenic or toxic  to reproduction,  that this  freedom  is  limited  by 

prescribing  which  measures  shall  have priority.  Other specific  measures  should  be 

established e.g.  limit values,  only when this is shown to be necessary. 

12. 

As  further  evidence  that  the  measures  required  by  this  proposal  are 

reasonable  in  proportion  to  the  risks  from  chemical  agents  it  should  be  noted  that 

they  follow  closely  the  Convention  on  Chemicals  adopted  by  ILO  in  1990  and 

therefore already have a substantial  measure of acceptance world-wide. 

d) 

The case for consolidation of existing provisions. 

13. 

The Council  Resolution  of  21.12.1987  (2) on the Commission's  programme 

concerning  safety,  hygiene  and  health  at  work  (3)  welcomed  the  intention  to  bring 

forward  further  proposals  concerning  dangerous  agents.  Moreover,  at  the  time  of 

the  adoption  of  the  Framework  Directive  89/391/EEC  the  Council, 

in  a 

Declaration,  invited  the  Commission  to  examine  coherence  between  the  new 

Directive  and  Directive  80/1107/EEC  on  chemical,  physical  and  biological  agents 

(4).  This is indispensable in order to bring the existing related individual  Directives 

on  specific  chemical  agents  into  conformity  with  Directive  89/391/EEC  and  in 

particular to remove ambiguities in existing requirements. 

14. 

The  further  need  for  consolidation  of  the requirements  relating  to  chemical 

agents  and  to  ensure  harmony  of  content  and  approach  in  relation  to  the  new 

Framework Directive  89/391/EEC was emphasised by the Council at the time of the 

(2> 
<3> 
<4> 

OJ. N* C28 of 03.02.1988, p. 1 
O.J. N'  C28 of 03.02.1988, p. 4 
OJ. N* L327 of 03.12.1980, p. 8 

adoption  of  Council  Directive  90/394/EEC  "on the protection  of  workers  from  the 

risks related to exposure to carcinogens at work" (5), 

15. 

The  current  proposal  responds  to  these  various  invitations.  However,  it  is 

proposed  that carcinogens  should  continue  to  be  covered  by  a  separate  text.  This 

exception  also  covers  asbestos  and  vinyl  chloride  monomer  both  of  which  are 

already  classified  as  human  carcinogens  (R  45)  and  which  are,  therefore,  already 

within  the scope of  Directive  90/394/EEC  on  carcinogens.  In the case  of  asbestos 

and  vinyl  chloride  monomer,  the  detailed  requirements  contained  in  Directives 

83/477/EEC  as amended  by  Directive  91/382/EEC  and Directive  78/610/EEC  will 

be  reviewed  separately  taking  account  of  the  more recent Directive  on  carcinogens 

covering all classified  R 45 substances. 

16. 

It  should  also  be  noted  that  biological  agents,  which  are  included  in  the 

coverage of  Directive  80/1107/EEC which covers physical,  chemical  and  biological 

agents  are  now  subject  to  a  specific  Directive  90/679/EEC  for  the  protection  of 

workers  from  the  risks  related  to  exposure  to  biological  agents  at  work  (6). 

Furthermore,  a  separate  proposal  is  in  preparation  to  deal  with  physical  agents. 

Thus the adoption of Directives on biological  agents and physical agents  will  render 

Directive  80/1107/EEC  obsolete  for  these  agents.  Therefore  the  present  proposal 

deals  only  with  chemical  agents.  At  the  same  time  as  the  Directive  on  chemical 

agents comes into force,  the outdated Directives will be repealed. 

17.  When  Directive  80/1107/EEC  was  modified 

in  1988  by  Directive 

88/642/EEC(7)  one of the amendments was to introduce a detailed Annex relating  to 

technical aspects concerning  the measurement of  exposure to chemical  agents.  This 

Annex  made reference  to the  use  of  CEN  standards.  Since  that  time  several  draft 

(5> 
<6) 
(7> 

OJ.  N'  L196 of 26.07.1990, p. 1 
O J.  N'  L374 of 31.12.1990, p. 1 
O J.  N'  L356 of 24.12.1988, p. 74 

CEN  standards  have  been  developed  as  part  of  the  standardisation  policy  of  the 

European  Community.  Such  standards  will  be  of  particular  relevance  to  chemical 

agents.  Three standards are in the process of adoption namely: 

1.  CEN standard on  "Guidelines for the assessment  of  exposure  to chemical  agents 

in the air at the workplace for comparison with Limit Values".  (Pr EN 689) 

2.  CEN  standard  on  "General  requirements  for  the performance  of  procedures  for 

workplace measurements".  (Pr EN 482) 

3.  CEN standard on  "Specifications  for conventions  for  measurement of  suspended 

matter in workplace atmospheres".  (Pr EN 481) 

18. 

The above-mentioned draft CEN standards will,  after  their adoption,  provide 

comprehensive  guidance  on  carrying  out  measurements  of  exposure.  For  this 

reason  detailed  guidance  on  measurement  methods  is  not included  in  the  Annex  of 

the current  text  and  some  of  the detailed  requirements  from  Directive  82/605/EEC 

on lead are being omitted without reducing the level of protection provided. 

Objectives  of  the  Current  Proposal 

19. 

This proposal has the following  objectives : 

(a) 

to establish  minimum requirements  for the protection  of  workers against 

risks to their health and safety arising from all chemical agents at work; 

(b) 

to  consolidate,  update  and  adapt  existing  provisions  in  relation  to 

chemical agents in the light of current knowledge and to align them with 

the measures established in Directive 89/391/EEC; 

(c) 

to  encorporate  into  the  new  text  the  individual  Directive  82/605/EEC 

relating  to exposure to metallic lead and its compounds and the Directive 

88/364/EEC  relating  to  the banning  of  certain  agents  and  certain  work 

activities; 

(d) 

to  establish  additional  requirements  with  respect  to  improving  the 

protection  of  workers  against  the risks arising  from  activities  involving 

chemical agents; 

(e) 

to  remove  ambiguities  in  the  requirements  of  existing  Directives  and 

uncertainty  in the extent of their application; 

(f) 

to clarify  the Community  provisions  relating  to  the health  and safety  of 

workers  exposed  to  chemical  agents,  and  to  provide  an  improved  basis 

for the provision of information  to workers; 

(g) 

to ensure  that all precautionary  measures at work  are based  on a proper 

assessment  of  risks  arising  from  the  way  chemical  agents  are  used and 

that  measures  to  afford  protection  take  account  of  the  features  of  the 

workplace,  the activity,  the circumstances and any  specific  risk.  In this 

way,  the  measures  taken  can  properly  reflect  the  scale  of  risk,  the 

appropriate  precautions  and  the  size  of  the  undertaking  without 

unnecessarily  imposing burdens on employers; 

(h) 

to render  more explicit  the existing  alignment  of  Community  provisions 

with 

the 

ILO  Convention  No. 

170 

(8)  and 

its  associated 

Recommendation  No.  177 on Chemical Agents at work; 

(8) 

Convention No  170 concerning safety in the use of chemicals at work, adopted by the 
International Labour Conference at its 77th session, Geneva, 25 June  1990 

10 

(i) 

to  ensure  that  the  Directive  on  Carcinogens  (90/394/EEC)  remains  in 

force,  and  is  excluded  from  this  text,  as  it  contains  specific  additional 

requirements for carcinogenic chemical agents. 

Description  of  this  proposal 

20. 

This proposal  comprises  a preamble,  three  parts and  an  Annex  which  sets 

out minimum health and safety  requirements: 

a) 

Contents of the proposal 

Proposal for a Council Directive on the protection of  the health and safety  of 

workers from the risks related to chemical agents at work 

Preamble 

Section I : General provisions 

Article  1 

Subject 

Article 2 

Definitions 

Section II : Provisions addressed to employers 

Article 3 

General obligations 

Article 4 

Specific  protection and prevention measures 

Article 5 

Communication,  warning and alarm systems 

3) 

11 

Article 6 

Keeping  workers informed 

Section III  : Miscellaneous provisions 

Article 7 

Prohibitions 

Article 8 

Occupational exposure levels 

Article 9 

Health surveillance 

Article  10 

Consultation and participation of  workers 

Article  11  Minimum  requirements for health and  safety 

Article  12 

Adjustments to the Annex 

Article  13 

Committee 

Article  14 

Revocation 

Article  15 

Final  Provisions 

Article  16 

Address 

Annex 

Minimum  Safety  and  Health  requirements  as  referred  to  in  Article  11  of  the 

Directive. 

b) 

Characteristics of  this proposal 

12 

1. 

Preamble 

2. 

Section I : General Provisions 

Article 1 

This  Article  establishes  the  Directive  as  an  individual  Directive  under 

the Framework  Directive  89/391/EEC,  its requirements  therefore  being 

minimum requirements under Article 118A of the Treaty. 

Article  2 

The  definition  of  'chemical  agent'  in  this  text  is  very  broad,  with  the 

aim  of  bringing within  its  scope all chemical agents,  while ensuring  in 

the text that the requirements  imposed  are commensurate  with  the risk. 

It covers all forms of chemical agents, such as fumes,  contaminants and 

wastes that may arise in the course of work activities as well as chemical 

agents that are produced or used intentionally. 

3. 

Section  II  : Provisions  addressed  to  employers 

Article  3 

This Article places an obligation on the employer to ensure that workers 

can  carry  out  their  work  without  endangering  themselves  or  others  at 

work. 

13 

Because  an  assessment  of  workplace  hazards  and  risks  is  an  important 

practical  contribution  to  the  actions  which  an  employer  must  take  to 

protect  health  and  safety,  this  Directive  adapts  the  requirements  laid 

down in Directive  89/391/EEC  so that assessments are made of  the risks 

incurred by  the workers in any activity  involving  chemical  agents.  The 

assessment has to cover all the chemical agents that are used or likely  to 

be used. 

For  chemical  agents  which  have  been  the  subject  of  specific  evaluation 

within the Community  as part of  the process of  authorisation  for placing 

on the market, e.g.  for plant protection products,  this evaluation and any 

related  labelling  or  safety  instructions  will  often  provide  the basis  for  a 

major part of  the work assessment  under this Directive.  What has to be 

done,  in  addition,  is  an assessment  of  the  way  in  which  the  hazards  of 

the chemical  agents interact with  other aspects of  the workplace and the 

methods of use. 

The  employer  is  also  required  to  ensure  supervision  of  the  workplace, 

that  competent  staff  are  employed  for  important  tasks  such  as  the 

assessments  and  work  involving  special  risks,  that  arrangements, 

including first-aid facilities,  are made to deal with emergencies,  and that 

clear instructions are given to workers. 

The  Article  also  establishes  the  principle  that  priority  is  given  to 

collective  protection  measures  in  preference  to  individual  protection 

measures. 

14 

Article 4 

This  Article  sets out general  requirements  for  the arrangements  of plant 

and equipment  so as to reduce risks to the  health  and  safety  of  workers 

at work. 

Article  5 

This Article places an obligation  on the employer  to  make arrangements 

to provide warning if there is an increased risk to health and safety. 

Article  6 

This  Article  is concerned  with  making  information  available  to workers 

about the chemical agents and precautions to be taken. 

Section  III  : Miscellaneous  provisions 

Article  7 

The  prohibitions  at  present  contained  in  Directive  88/364/EEC  on  the 

banning  of  certain  specific  agents and/or  work  activities  are included in 

this Article without  material change.  Provision  is made for new bans to 

be  added  by  Council  based  on  Article  118  A  of  the  Treaty,  whereas 

technical  amendments to existing provisions are  to be carried  out by the 

Commission  in accordance with the procedure referred  to in Article 13. 

15 

Article 8 

Co-operation  already  exists  between  Member  States  in  the  scientific 

process  leading  to  the  establishment  of  occupational  exposure  levels. 

The  text  lays  down  a  Community  framework  so  that  in  the  future  this 

co-operation can be developed in a systematic way at Community  level. 

The  concept  of  having  two  different  types  of  occupational  exposure 

levels,  of different  status, is retained. 

'Limit values'  under  this proposal  incorporate the  'binding  limit  values' 

under Directive  88/642/EEC  and the existing  limit  value  for  lead  under 

Directive 82/605/EEC.  Member States will be required to set a national 

occupational  exposure  level  once  a  Community  limit  value  has  been 

established which shall not be exceeded. 

For  'occupational  guidance values',  Member States are to be required  to 

take  them  into  account  if  they  set  or  revise  a  national  limit  for  a 

particular chemical agent. 

During  the  five  year  period  before  an  occupational  guidance  value  is 

reviewed,  all  interested  parties  will  have  the  opportunity  to  submit 

information arising from experience gained in its practical application. 

16 

Article  9 

This  Article  sets  out  general  arrangements  for  the  provision  of  health 

surveillance,  with  particular  reference  to  activities  involving  chemical 

agents. 

Article  10 

This  Article  adapts  the  general  arrangements  for  consultation  and 

participation  of  workers  set  out  in  Article  11  of  Directive  89/391/EEC 

to activities involving chemical agents. 

Employers  are obliged  to  involve  workers  in  appraising  the  workplace 

and  on  the  precautions  to  be  adopted  when  it  is  found  that  an 

occupational exposure level or biological  limit value is exceeded. 

Article  11 

This Article establishes the time scale in which employers  shall  meet the 

minimum  requirements  for  health  and  safety  which  are  set  out  in  the 

Annex.  For new  activities,  the  employer  shall  comply  at  the  time  this 

Directive  comes  into  force;  for  existing  activities  there  is  a  transition 

period of five years. 

Article  12 

This  Article sets out arrangements  for  technical  adjustments  to  be  made 

to the Annex and provides for the establishment of technical guidance. 

17 

Article  14 

The  Directives  listed  will  become  redundant  on  the  adoption  of  this 

Directive  and  are  therefore  to  be  repealed. 

It  is  to  be  noted  that 

Directive  80/1107/EEC covers chemical,  physical  and biological  agents. 

Of 

these,  biological  agents  are  already  covered  by  Directive 

90/679/EEC  and  physical  agents  are  the  subject  of  a  separate  proposal 

already  under discussion. 

The  three  individual  Directives  under  Directive  80/1107/EEC  can,  in 

principle,  stand  alone  even  if  80/1107/EEC  is  repealed.  However  the 

first  individual  Directive  on  lead  (82/605/EEC)  is  already  assimilated 

into  the  present  proposal  and  can  be  repealed  also.  The  second,  on 

asbestos  (83/477/EEC  as  amended  by  91/382/EEC)  will  be  the  subject 

of  a separate  review  to be carried out by 31  December  1995  persuant to 

Article  9(1)  of  Directive  83/477/EEC  as amended.  The  third,  on  noise 

(86/188/EEC)  will  be consolidated  into  the proposal  relating  to physical 

agents referred  to above.  The  fourth on banning  certain  specified  agents 

and/or  work  activities  (88/364/EEC)  is  already  assimilated  into  the 

current proposal  and can therefore  be repeated. 

18 

ANNEX 

1. 

Preliminary note 

The  Annex  sets  out  minimum  safety  and  health  requirements  which 

apply  whenever  appropriate  taking  account  of  the  features  at  the 

workplace,  the activity,  the circumstances or a specific risk. 

2. 

Supervisory  obligations 

The  text  sets  out  the  requirements  for  competence  of  the  person  in 

charge of  the workplace and those supervising  workers.  It explains that 

the  employer  may  personally  fill  these  roles  so  long  as  he  meets  the 

requirements for competence. 

3. 

Protective measures 

This  paragraph  is  concerned  with  the  concentration  in  air  of  chemical 

agents which might present a risk to the health and safety of workers. 

The  employer  is  obliged  to  ensure  that  the  exposure  of  workers  to  a 

chemical  agent for  which a limit value has been  set does  not exceed  the 

occupational  exposure 

limit. 

Arrangements  are  summarised 

for 

assessing and measuring the exposure of workers. 

4) 

19 

4. 

Protection from abnormal risks 

This  paragraph  requires  the  employer  to  give  special  consideration  to 

activities,  such  as  maintenance,  where  the  risks  may  be  increased 

because  the  normal  process  controls  cannot  be  applied.  It  also  covers 

situations  such  as  an  emergency  and  where  remedial  action  has  to  be 

taken  after  an  accident  or  incident  and  requires  the  employer  to  make 

arrangements as to how to deal with such events, if they occur. 

5. 

Derogation  information 

This  paragraph  states  the  information  to  be  provided  to  competent 

authorities where derogations is sought from the prohibitions. 

6. 

Safety equipment maintenance 

General requirements are set out. 

7. 

Health surveillance  measures 

For  some  chemical  agents  the  Commission  believes  that  specific 

provisions  on  health  surveillance  are  necessary.  These  agents  fall  into 

two categories: 

-  sensitisers; 

-  other specified  dangerous chemicals as referred to in this paragraph of 

the Annex. 

20 

For these agents,  health surveillance is to be provided. 

Biological  limit  values  and  related  requirements  are  to  be  observed  as 

part of health surveillance. 

8. 

Record keeping 

The  paragraph  sets  out  arrangements  to  be  made  by  an  employer  to 

maintain  a  record  of  the  safety  and  health  document.  It  also  provides 

for Member States to arrange for individual health records. 

9. 

Information on chemical agents 

This  paragraph  requires  the  employer  to  provide  the  worker  with  the 

information  that is  necessary  to  ensure  safe  working  practices.  Where 

appropriate  and 

in 

line  with  other  Community  Directives, 

the 

information is to be provided by signs,  labels and safety  sheets. 

An  obligation  is  placed  on  the  employer  to  ensure  that  containers  and 

pipes  used  for  chemical  agents  at the workplace are  labelled  or  marked 

in  line  with  Directive  92/58/EEC.  In  many  cases  the  products  bought 

by  the  employer  will  already  be  clearly  marked  with  their  identity  and 

hazards  according  to  other  legislation.  Where  the  original  labelling  is 

not  available  e.g.  when  the  chemical  is  transferred  in-plant  to  another 

container,  the employer  must  make other arrangements.  At  the  time  of 

the adoption of the 7th amendment to Directive 67/548/EEC  the Council 

specifically  invited  the  Commission  to  make  proposals  in  this  matter 

with respect to intermediates. 

21 

There are also obligations  to  make available  to workers  the  Safety  Data 

Sheets from the supplier and where these are not available to prepare an 

equivalent data sheet. 

10. 

limit Values and Biological Limit Values 

This paragraph sets out the limit  values  and biological  limit  values  that 

have been established.  At present there are the limit value for lead in air 

at  the  workplace,  and  the  biological  limit  value  (which  indicates 

absorption  of  lead by  the worker).  The list of  values  may  be  extended 

in due course. 

When  Directive  82/605/EEC  on  risks  related  to  exposure  to  lead  was 

adopted  there was a requirement  to review  the exposure  limit  value  for 

lead  and the biological  limit values  with a view  to  reducing  them.  The 

current  proposal  confirms  the  biological  limit  value  in  blood  of 

70fig/100  ml  as  a  minimum  requirement;  however  it  removes  the 

latitude set out in Directive 82/605/EEC  which permitted a lead in blood 

level of between 70 and 80/ig Pb/100 ml under certain circumstances. 

11. 

Special measures for lead. 

This paragraph sets out other means of biological  monitoring  for lead. 

22 

OPINION  OF  T HE  ADVISORY  COMMITTEE 

The opinion of the Advisory Committee on Safety,  Hygiene,  and Health 

Protection at Work has been obtained on the proposal.  The Commission 

has taken due note of the Committee's opinion in preparing the text now 

submitted  to  the  Council,  in  particular  in  relation  to  the  procedure  for 

setting  limit  values,  the requirements  for  the assessment  and  for  record 

keeping,  the  strengthening  of  the  provisions  relating  to  safety,  and  the 

limit  value  for  lead  in  air,  which  remains  unchanged  from  the  limit 

valuein Directive 82/605/EEC on lead. 

IMPACT  A S S E S S M E NT 

An  impact  study  has  been  carried  out  and  a  copy  of  the  summary 

assessment is attached as Annex A to this explanatory  note.  It should be 

noted  that as a result of  this impact  study  the list of  chemical agents  for 

which  health surveillance is required,  under Article 9,  has been reduced 

by  more  than  half  from  the  draft  on  which the study was based. 

2 3 

PROPOSAL FOR A COUNCIL DIRECTIVE ON THE PROTECTION OF 

THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS 

RELATED TO CHEMICAL AGENTS AT WORK 

THE COUNCIL OF THE EUROPEAN COMMUNITIES 

Having  regard  to  the Treaty  establishing  the European  Economic  Community,  and 

in particular Article  118A thereof^ 

Having regard  to the proposal from  the Commission^*, drawn  up after  consultation 

with the Advisory Committee on Safety,  Hygiene and Health Protection at Work, 

In co-operation with the European Parliament^), 

Having regard to the opinion of the Economic and Social CommitteeC3) 

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; 

Whereas,  pursuant 

to 

that  Article,  such  Directives  must  avoid 

imposing 

administrative, financial and  legal  constraints  which  would  hold  back  the  creation 

and development of small and medium-sized undertakings; 

œ 
(2) 
0) 

O.J. No.... 
OJ. No.... 
OJ. No.... 

Whereas  the  improvement  of  workers'  safety,  hygiene  and  health  at  work  is  an 

objective which should not be subordinated to purely economic considerations; 

Whereas  the respect  of  minimum  requirements  on  the protection  of  the  health  and 

safety  of  workers  from  the  risks  related  to  chemical  agents  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  a  consistent  level  of  protection  from  the  risks related  to  chemical  agents 

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  a  work  activity  involving  chemical  agents  is  likely  to  expose  workers  to 

particularly high levels of risk; 

Whereas Council Directive 80/1107/EEC of 22 November  1980 on the protection  of 

workers  from  the  risks  related  to  exposure  to  chemical,  physical  and  biological 

agents  at work(4  )  as  last  amended  by  Council  Directive  88/642/EEC  (5),  Council 

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)(6),  and 

Council  Directive  88/364/EEC  of  9  June  1988 on the protection  of  workers  by  the 

banning of certain agents and/or  certain work activities  (fourth  individual  Directive 

<4> 
<5> 
<6> 

OJ. No. L327 of 03.12.1980, p. 8 
OJ. No. L356 of 24.12.1988, p. 74 
O J. No. L247 of 23.08.1982, p. 12 

zs 
within  the  meaning  of  Article  8  of  Directive  80/1107/EEC)(7)  should,  for  the  sake 

of  consistency  and  clarity  as  well  as  for  technical  reasons,  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  involving  chemical  agents;  whereas 

these Directives can be repealed; 

Whereas  this  Directive  is  an  individual  Directive  within  the  meaning  of  Article 

16(1)  of  Directive  89/391/EEC  of  12 June  1989  on  the introduction  of  measures  to 

encourage improvements in the safety and health of workers at work (8) ; 

Whereas,  therefore  the  provisions  of  the  said  Directive,  apply  in  full  to  workers 

exposed  to  chemical  agents,  without  prejudice  to  more  stringent  and/or  specific 

provisions contained in this Directive; 

Whereas  Council  Directive  67/548/EEC  of  27  June  1967  on  the  approximation  of 

the  laws,  regulations  and  administrative  provisions  relating  to  the  classification, 

packaging  and  labelling  of  dangerous  substances(9),  as  last  amended  by  Council 

Directive 92/32/EEC of 30 April  1992(10),Council Directive of 26 June  1978 on the 

approximation  of  hte  laws  of  the  Member  States  relating  to  the  classification, 

packaging  and  labelling  of  dangerous  preparations  (pesticides)  (n)  and  Council 

Directive  88/379/EEC  of 7 June  1988 on the approximation of  the laws,  regulations 

and  administrative  provisions  of  the  Member  States  relating  to  the  classification, 

packaging  and  labelling  of  dangerous  preparations^2),  as  last  amended  by  Council 

Directive  90/492/EEC(13),  define  and lay  down  a system of  specific  information  on 

dangerous substances and preparations,  in the form of  safety  data sheets,  principally 

C7) 
<*> 
<9> 
<10) 
U U 
<12> 
<1 3) 

OJ. No. L179 of 09.07.1988, p. 44 
O J. No. L183 of 26.09.1989, p. 1 
O J.  No. L196 of 16.08.1967,  p. 1 
O J.  No. L154  of  05.06.1992,  p. 1 
O.  J.  No.  L206  of  29.07.1978,  P. 13 
OJ. No. L187 of 16.07J988, p. 14 
OJ. No. L275 of 05 J0.1990, p. 35 

(5) 

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  92/58/EEC  of  24  June  1992  on  the  minimum 

requirements  for the provision of safety  and/or health signs at work(14)  establishes a 

system  for  marking  containers  and  pipes  used  for  dangerous  substances  or 

preparations at work; 

Whereas  Council  Directive  82/501/EEC  of  24  July  1982,  on  the  major-accident 

hazards  of  certain  industrial  activities(15)  has  as  its  objective  the  limitation  of  the 

consequences  of  such  accidents  to  man  and  the  environment  and  to  ensure  high 

levels  of  protection  against  such  accidents  and  their  consequences  throughout  the 

Community; 

Whereas,  in  order  to complete  the information  available  to workers  so as  to ensure 

an  improved 

level  of  protection, 

it 

is  necessary  that  workers  and  their 

representatives 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  that  they  should  be  in  a  position  to  check  that  the  necessary  protective 

measures are taken; 

Whereas  employers  must  keep  abreast  of  new  developments  in  technology  with  a 

view  to  improving  the  protection  of  worker's  safety  and  health,  and  assess  on  a 

regular basis the implications for the safety  and health of workers; 

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 

<14) 
<15> 

O J. No. L245 of 26.08.1992, p. 23 
OJ  No L 230 of 05.08.1982, p.l 

29 

cease  to exist,  a reduction  in exposure  to chemicals  agents will  none the  less  reduce 

these risks: 

Whereas Commission  Directive 91/322/EEC of 29  May  1991,  establishes  indicative 

limit values as provided  for by Council  Directive  80/1107/EEC on the protection  of 

workers  from  the risks relating  to chemical,  physical  and biological  agents  at work 

and  whereas  the  former  Directive  should  be  maintained  as  part  of  the  current 

framework: 

Whereas  technical  implementing  measures  tor  the  application  of  this  Directive 

should be entrusted to the Commission  in close co-operation  with the Member States 

using the procedure provided  in Article  13: 

Whereas  this  Directive  is  a  practical  contribution  towards  creating  the  social 

dimension of  the internal  market. 

HAS ADOPTED THIS  DIRECTIVE : 

zt 

SECTION I 

GENERAL PROVISIONS 

Article 1 

Subject 

1.  This  Directive,  which  is  the  [  ]  individual  Directive  within  the  meaning  of 

Article 16(1)  of Directive 89/391/EEC, lays down minimum requirements  for 

the  protection  of  workers  against  risks  to  their  health  and  safety  arising,  or 

likely  to  arise,  from  the  effects  of  chemical  agents  that  are  present  at  the 

workplace or as a result of any work activity involving chemical agents. 

2.  The  requirements  of  this  Directive  apply  to  all  chemical  agents  at  work, 

without  prejudice 

to  other  Community  provisions  under  Directive 

82/501/EEC,  as amended,  on the major  accident hazards of  certain  industrial 

activities  and  the  provisions  for  chemical  agents  to  which  measures  for 

radiation  protection  apply  pursuant  to  Directives  adopted  under  the  Treaty 

establishing the European Atomic Energy Community. 

3. 

For carcinogens at work the provisions of Directive 90/394/EEC  apply  where 

these are more favourable to the safety and health of workers at work. 

4.  The provisions  of  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. 

g  ^ r vo 

5 • 

The  competent  authorities  shall  regularly  check  if  employers  have  taken  the 

appropriate  measures to protecdt the health and safety  of  workers at work and 

review  the risk assessment pursuant to Article 3(2). 

29 
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  by any  work  activity, 

whether  or  not  produced  intentionally  and  whether  or  not  placed  on  the 

market; 

(b)  "Activity  involving  chemical  agents"  means  any  work  in  which  chemical 

agents  are  used,  or  are  intended  to  be  used,  in  any  process,  including 

production,  handling,  storage,  transport  or  disposal  and  treatment,  or  which 

result from  such work. 

(c)  "Occupational  exposure  level  "  means,  unless  otherwise  specified 

,  the 

concentration  of  a  chemical  agent  at  the  workplace  in  the  air  within  the 

breathing  zone  of  a  worker  and  includes  "limit  value"  and  "  occupational 

guidance value"; 

(d)  "Biological  limit  value"  means  the  limit  of  concentration  in  the  appropriate 

biological  medium,  of  the  relevant  agent,  its  metabolite,  or  an  indicator  of 

effect; 

(e) 

"Hazard" means the intrinsic property of a chemical agent with the potential to 

cause harm; 

3o 

(f) 

"Risk"  means the likelihood that the potential  for  harm  will be attained  under 

the conditions of use and/or exposure; 

(g) 

"Competent  person"  means  any  person  who  has  the  necessary  knowledge, 

experience, practical ability and skills to perform  the task in question; 

(h) 

"Waste" means any chemical agent remaining after  a process, or any object or 

material contaminated by a chemical agent, which is intended for disposal; 

(i) 

"Health  surveillance"  means  the  assessment  of  an  individual  worker  to 

determine the state of health of this individual. 

SECTION II 

PROVISIONS ADDRESSED TO EMPLOYERS 

Article 3 

General obligations 

1.  To  safeguard  the  safety  and  health  of  workers  the  employer  shall  take  the 

necessary  measures including the assignation of specific  duties to a competent 

person to ensure that for activities involving chemical agents: 

a)  workers  can  perform  the  work  assigned  to  them  without  endangering 

their safety and health and/or those of other workers; 

31 

b) 

the operation of  workplaces when workers are present  takes place under 

the responsibility  of a person in charge; 

c)  work  involving  a  special  risk  is  entrusted  only  to  competent  staff  and 

carried out in accordance with the instructions given; 

d) 

effective  arrangements are made to deal with accidents and emergencies, 

including  any relevant safety  drills which are to be performed  at regular 

intervals; 

e) 

all  safety  and  health  instructions  are  comprehensible  to  the  workers 

concerned; 

f) 

appropriate first aid facilities are provided. 

2. 

The employer  shall be  in possession  of  an assessment  of  the risks concerning 

safety  and  health  drawn  up  in  a  Document,  hereinafter  referred  to  as  the 

"safety  and health document",  which shall be kept up-to-date. 

The  safety  and  health  document  shall  identify  any  risk  at  work  and 

record in particular: 

an  assessment  of  the  risks  incurred  by  the  workers  in  any  activity 

involving  chemical  agents,  and  that  a competent  person  has  carried  out 

this  assessment;  where  a  chemical  agent  has  been  subject  to  a  specific 

evaluation  concerning  the  risks  for  its  users  as  part  of  a  process  of 

authorisation  for  placing  on  the  market,  the  risk  assessment  shall  take 

into account the results of that evaluation; 

3^ 

that adequate  measures  will  be  taken  to attain  the  aim  of  the  Directive 

and  in  particular  any  precautionary  measures  to  protect  the  health  and 

safety of  workers provided for in other Community  legislation; 

that  the  design,  use  and  maintenance  of  the  workplace  and  of  the 

equipment involving chemical agents are safe; 

that an up-to-date list  has been  made of  the chemicals  used,  or intended 

to be used at work. 

The safety and health document  must be drawn up prior to the commencement 

of  work  and  shall  be  kept  up-to-date  in  particular  if  there  have  been  major 

changes which could render it out-of-date. 

The employer shall ensure that the workers are informed  of  the contents of the 

safety and health document whenever a major alteration at the workplace leads 

to a change in the document. 

3. 

The  employer  shall  ensure  that  the  risk  from  a  chemical  agent  to  the  safety 

and  health  of  workers  at  work  is  eliminated  or  reduced  in  particular  by 

eliminating  the risk at source or by seeking  to achieve the maximum  degree of 

reduction  of  risk  by  collective  protection  measures  in  particular  cleaner 

technologies  and  the  state  of  art  and  technology,  in  preference  to  individual 

protection measures. 

4. 

For certain  special  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  on  safety  and 

health for other reasons,  even after all technical measures have been taken, the 

33 

employer  shall  determine,  after  consultation  of  the  workers  or  their 

representatives in the undertaking or establishment,  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. 

The employer shall ensure that these activities take place only  in areas that are 

clearly  demarcated  and  indicated,  or  that  persons  not  specifically  authorised 

are prevented by other means from having access to such areas. 

5. 

The  measures  taken  by  the  employer  to  meet  the  requirements  of  this 

Directive  shall  be  consistent  with  the  need  to  protect  public  health  and  the 

environment 

Article 4 

Specific  protection and prevention  measures 

The employer shall take measures appropriate to the nature of the risk : 

to provide suitable and safe plant and process equipment; 

to limit the quantity  of  a  hazardous chemical agent at the workplace and 

to segregate incompatible chemical agents; 

to  avoid,  detect  and  combat  the  starting  and  spread  of  fires  and 

explosions, and 

to prevent the occurrence of explosive and/or hazardous atmospheres. 

3  if 

Article 5 

Communication, warning and alarm systems 

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  assistance,  escape  and  rescue  operations  to  be  launched 

immediately if the need arises. 

Article 6 

Keeping workers informed 

1.  Without prejudice to Article  10 of Directive 89/391/EEC workers and/or their 

representatives shall be provided with: 

information  on  chemical  agents,  as  referred  to  in  paragraph  9  of  the 

Annex,  in  a  comprehensible  form  and  adapted  to  the  needs  of  the 

individual worker; 

information  on appropriate precautions  and actions to be taken  in  order 

to safeguard  himself and other workers at the workplace; 

written information  where the assessment carried  out pursuant to Article 

3.2  shows it to be necessary and which is kept up-to-date. 

3-T 

2.  The  employer  shall  ensure  that  containers  used  for  chemical  agents  at  work 

are provided  with  safety  signs or are marked  with  the identity  and  the nature 

of  the  contents  and  their  hazards.  Where  a  safety  data  sheet  has  not  been 

provided  at  the  time  of  supply  the  employer  shall  obtain  the  relevant 

information from the supplier or other sources, and shall not use the chemical 

agent until such information  has been obtained and made available to workers. 

SECTION III 

MISCELLANEOUS PROVISIONS 

Article 7 

Prohibitions 

1.  The  production,  manufacture  or  use  at  work  of  chemical  agents  and  work 

activities set out below are prohibited  to the extent specified.  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. 

Z€ 

EINECS  (1) 
No 

CAS  (2) 
No 

Name of agent 

;  202-080-4 

;  202-177-1 

202-199-1 

•  202-204-7 

91-59-8 

92-67-1 

92-87-5 

92-93-3 

2-naphmylamine 
and its salts 
4-aminodiphenyl 
and its salts 
Benzidme and its 
salts 
4-nitrodipheiiyl 

Concentration 
Limit for 
exemption 
0.1  % w/w 

0.1  %  w/w 

0.1  %  w/w 

0.1  % w/w 

(1) EINECS : European Inventory of Existing Chemical Substances 

(2) CAS : Chemical Abstract Service 

2.  An  application  from  an  employer  Member  States  may  grant  specific 

derogations  from  the  requirements  of  paragraph  1  in  the  following 

circumstances: 

for  the  sole  purpose  of  scientific  research  and  testing,  including 

analysis; 

for  work  activities  intended  to  eliminate  the  prohibited  chemical 

agents; 

provided  that the production or use is  earned  out in  a  closed  system 

and  that  the  chemical  agent  no  longer  remains  at  the  end  of  the 

process. 

3.  :  Amendments required with regard to the chemical agents and work activities 

already  covered  by  this  Article  shall  be  determined  and  adopted,  in 

accordance with the procedure referred to in Article 13. 

3=? 

Article 8 

Occupational exposure levels 

1.  Occupational  exposure  levels  shall  be  drawn  up  taking account  of  available 

information,  including  scientific  and  technical  data  in  accordance  with  the 

procedure referred to in Article 13. 

2.  Eor  any  chemical  agent  for  which  a  limit  value  is  listed  in  the  Annex 

(paragraph  10),  Member  States  shall  establish  a  corresponding  occupational 

exposure level which shall not be exceeded. 

3.  Occupational  exposure  levels  established  as  indicative  limit  values  by 

Directive  91/322/EEC  shall  be  considered  as  occupational  guidance  values 

for the purpose of this Directive. 

4.  Member  States  shall  take  into  account  occupational  guidance  values  when 

setting occupational exposure levels on their own territories. 

5.  When a Member State introduces  or revises an occupational  exposure  level 

for  a  chemical  agent,  on  the  basis  of  new  data,  it  shall  inform  the 

Commission  and the other Member States thereof together with the relevant 

scientific and technical data. 

3% 

Article 9 

Health Surveillance 

Member  States  shall  establish  arrangements  to  ensure  that  workers  receive 

health  surveillance  appropriate  to  the  safety  and  health  risks  they  incur  at 

work, in accordance with Article  14 of Directive 89/391/EEC. 

Article 10 

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.  In particular  the employer  shall  make arrangements  to  facilitate 

the  participation  of  workers  and/or  their  representatives  in  appraising  their 

workplace and in the establishment of the precautions to be adopted when it is found 

that an occupational exposure level or biological limit value is exceeded. 

33 

Article 11 

Miriinmm requirements for health and safety 

1.  A  new  activity  involving  chemical  agents  for  the  first  time  after  the  date  on 

which  this  Directive  is  brought  into  effect  as  referred  to  in  Article  14,  must 

satisfy  the minimum safety and health requirements laid down in the-Annex. 

2.  An  activity  involving  chemical  agents  existing  on  the  date  on  which  this 

Directive  is  brought  into  effect  as  referred  to  in  Article  14,  must  satisfy  the 

: minimum  safety  and  health  requirements  laid  down  in  the  Annex  as  soon  as 

possible and at the latest five years after that date. 

Article 12 

Adjustments to the Annex 

1-  Technical adjustments to the Annex in line with : 

-the  adoption  of  Directives  in  the  field  of  technical  harmonisation  and 

standardisation  concerning chemical agents, 

and/or 

technical  progress,  changes  in  international  regulations  or specifications  and  new 
findings concerning chemical agents, 

shall be adopted in accordance with the procedure laid down in Article 13. 

Detailed  rules  on  technical  guidance  for  the  implementation  of  the  provisions 
contained  in  this  Directive  shall  be  adopted  in  accordance  with  the  procedure 
referred to in Article 13. 

Article 13 

Committee 

1. 

The Commission shall be assisted by the committee created in Article 17(1) of 
Directive 89/391/EEC. 

2.  Where reference is made to the procedure laid down in this Article the matter 
shall be referred to the Committee by Hie chairman either on his own initiative 
or at the request of the representative of a Member State. 

The representative of the Cornmission shall submit to the committee a draft of 
the measures to be taken.  The committee shall deliver its opinion on the draft 
within a time limit which the chairman may lay down according to the urgency 
of  the matter.  The opinion  shall be delivered by the majority laid  down in 
Article  148(2)  of  the  Treaty  in  the  case  of  decisions  which  the  Council  is 
required  to  adopt  on  a  proposal  from  the  Commission.  The  votes  of  the 
!  representatives of the Member States within the committee shall be weighted in 

the manner set out in that Article.  The chairman shall not vote. 

40  eu 

The tanirnission shall  adopt the measures  envisaged  if  they  are in  accordance 
with the opinion of the committee. 

If  the  measures  envisaged  are  not  in  accordance  with  the  opinion  of  the 
committee,  or if  no opinion is  delivered,  the Commission  shall,  without delay, 
submit  to  the  Council  a  proposal  relating  to  the  measures  to  be  taken.  The 
Council shall act by a qualified majority. 

If, on the expiry of three months from the date of the referral to the Council, the 
Council  has  not  acted,  the  proposed  measures  shall  be  adopted  by  the 
Commission. 

Article 14 

Revocation 

1.  The following Directives shall be repealed on the date this Directive comes into 

force : 

Directive  80/1107/EEC,  as  amended  by  Directive  88/642/EEC,  on  the 
protection of workers from the risks related to exposure to chemical, physical 
and biological agents at work; 

Directive 82/605/EEC on the protection of workers from the risks related 

to exposure to metallic lead and its ionic compounds at work; 

Directive  88/364/EEC  on  the protection  of  workers  by  the  banning  of 

certain specified agents and/or certain work activities. 

H4 

2. 

The reference in : 

Article  15(1)  of  Directive  83/477/EEC  and Article  1(5)  of  Directive 

91/382/EEC  amending  Directive  83/477/EEC  on  the  protection  of 

workers from the risks related to exposure to asbestos at work; 

Article  12(2)  of  Directive  867188/EEC on  the protection  of  workers 

from the risks related to exposure to noise at work; 

to the, procedure set  out Jn Article  10  of  Directive  80/1107/EEC  shall  be 

construed as a reference to the procedure laid down in Article 13. 

3.  Any other reference in : 

Directive  83/477/EEC,  as amended by Directive 91/382/EEC,  on the 

protection of workers from the risks related to exposure to asbestos at 

work; 

Directive  86/188/EEC  on  the  protection  of  workers  from  the risks 

related to exposure to noise at work; 

Directive  91/322/EEC  on  establishing 

indicative 

limit  values  by 

implementing  Council  Directive  80/1107/EEC  on  the  protection,  of 

workers  from  the risks related  to  exposure  to  chemical,  physical  and 

biological agents at work; 

to Directive 80/1107/EEC, as amended by Directive 88/642/EEC, is obsolete. 

Article 15 

Knal provisions 

1.  Member  States  shall  bring  into  fbrce  the  laws,  regulations  and  adrnimstrative 

provisions necessary to comply with this Directive not later man 30th June 1996. 

They shall forthwith inform the Cornrnission thereof. 

2.  When Member States adopt the provisions referred to in paragraph 1, these shall 

ccmtam-a_rfifecence to this Directive or shall be accompanied by such icfeBCfltc at 

the time of their official  publication.  The procedure for such reference  shall be 

adopted by Member States. 

3.  the  Member  States  shall  communicate  to  the  Qnnrmssion  the  texts  of  the 

provisions of national law which they have already adopted or which they adopt in 

me field governed by this Directive. 

4. :  Member States shall report to the Commission every five years on 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. 

•\3 

Article 16 

This Directive is addressed to the Member States. 

Done at 

For the Council 

The President 

MM 
ANNEX 

Minimum Safety and Health Requirements as 

referred  to in Article 11 of the Directive 

1.  Preliminary note : 

The  obligations  laid  down  in  this  Annex  apply  whenever  required  by  the 

features of the workplace, the activity, the circumstances or a specific risk. 

2. 

Supervisory  obligations 

2.2  Person in charge 

A responsible and competent person who has been appointed  by the employer 

in accordance  with  the national laws and/or  practices  must at all times be in 

charge of every workplace where chemical agents and workers are present. 

The employer may personally assume responsibility  for  the workplace  referred 

to in the first paragraph,  if  he has the skills and  competence required  for  the 

purpose in accordance with national laws and/or practices. 

2.3  Supervision 

To  ensure  workers'  health  and  safety  protection  during  all  operations 

undertaken,  the necessary supervision  must be provided by competent persons 

having  the  necessary  knowledge,  experience  and  skills  for  the  purpose,  in 

accordance with  national laws and/or  practices,  having  been  appointed  by the 

employer and acting on his behalf. 

The employer may personally undertake the supervision referred  to in the first 

paragraph  if  he  has  the  skills  and  competence  required  for  the  purpose,  in 

accordance with national laws and/or practices. 

3.  Protective measures 

3.1  Measures  must  be  taken  for  assessing  the  presence  of  harmful  and/or 

potentially  explosive  substances  in  the  atmosphere  and  for  measuring  the 

concentration of such substances. 

Where  required  by  the  safety  and  health  document  monitoring  devices 

measuring  gas  concentrations  at  specified  places  automatically  and 

continuously,  automatic  alarms  and  devices  to  cut  off  power  automatically 

from electrical installations and internal combustion engines must be provided. 

Where automatic measurements are provided for,  the values measured  must be 

recorded and kept as stipulated in the health and safety  document. 

3.2  The  employer  shall  ensure  that  any  chemical  agent  which  meets  the 

requirements  to  be  classified,  according  to  the  criteria  in  Annex  VI  of 

Directive 67/548/EEC, as a category  1 or 2 carcinogen,  mutagen  or chemical 

agent toxic to reproduction,  is as far  as is technically  possible,  eliminated  or 

replaced  by a chemical  agent  or  process  which  under  its  conditions  of  use is 

not dangerous, or is less dangerous,  to workers'  health and safety,  as the case 

may be.  Where it is not technically possible to replace the chemical agent by 

an agent or a process which  is not dangerous or is less dangerous  to workers' 

health  and  safety  the  employer  shall  reduce  risk,  giving  preference  to  the 

manufacture and use of the chemical agent in a closed system. 

3.3  The  employer  shall  ensure  that  exposure  of  workers  to  a  chemical  agent  at 

work  does  not  exceed  the  limit  value  set  for  that  chemical  agent  using  the 

procedure referred to in Article 8. 

3.4 

In  cases  where  exposure  occurs  simultaneously  to  more  than  one  chemical 

agent  for  which  limit  values  have  been  set,  the  effects  of  exposure  shall  be 

considered  as  additive,  unless  a  more  precise  evaluation  of  their  combined 

effect  is known. 

3.5  The  employer  shall  carry  out  such  periodic  measurements  of  chemical  agents 

at  the  workplace  as  are  necessary  in  particular  in  relation  to  limit  values, 

unless  by  other  means  the  employer  clearly  demonstrates  that  adequate 

protection  has  been  achieved.  Any  measurements  shall  be  made  by  a 

competent person,  using a valid technique. 

3.6  The  measurements  shall  be  carried  out  in  such  a  way  as  to  ensure  that  the 

result is  representative of  the exposure of  the worker to the agent or agents in 

question. 

4. 

Protection from abnormal  risks 

4.1 

In order to protect the health and safety  of  workers from an incident,  accident 

or  emergency  which  is  likely  to  result  in  abnormal  conditions  detrimental  to 

the  health  and  safety  of  workers,  the  employer  shall  establish  procedures 

(action plans) which can be put into effect  when any such event occurs,  so that 

appropriate action is taken. 

M> 

4.2 

In  case  of  the  occurrence  of  such  an  event  the  employer  shall  immediately 

inform  the  workers  thereof.  Until  the  situation  has  been  restored  to  normal 

and the cause of the abnormal conditions have been eliminated: 

the  employer  shall  identify  the  cause  without  delay  and  implement 

appropriate  measures to remedy the situation as soon as possible; 

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. 

4.3  The workers who are permitted  to work in the affected  area shall  be provided 

with  appropriate  protective  clothing,  personal  protective  equipment, 

specialised  safety  equipment  and  plant  which  they  must  use  so  long  as  the 

situation  persists;  that situation  shall  not be permanent.  Unprotected  persons 

shall not be allowed to remain in the affected  area. 

4.4.1 Where  harmful  substances  accumulate  or  may  accumulate  in  the  atmosphere 

appropriate  measures  must  be  taken  to  ensure  their  collection  at  source  and 

removal. 

Without  prejudice  to  provisions  for  the  protection  of  public  health  and  the 

environment  the  system  must  be  capable  of  dispersing  such  hazardous 

atmospheres in such a way that workers are not at  risk. 

4.4.2 Without prejudice to Directive  89/656/EEC  (16),  an appropriate and  sufficient 

breathing  and  resuscitation  equipment  must  be  available  in  areas  where 

workers may be exposed to atmospheres which are harmful to health. 

(16)  OJ No. L393, 30.12.1989, p. 18 

ws 

In  such  cases,  a  sufficient  number  of  workers  trained  to  use  such  equipment 

must be present at the workplace. 

The equipment must be suitably stored and maintained. 

4.4.3 Where toxic  gases are or may be present  in  the atmosphere,  a protection plan 

detailing  the protective equipment available and the preventive  measures taken 

must be kept and made available to the competent authorities. 

4.5  The  employer  shall  ensure  that  information  on  emergency  arrangements 

involving  chemical agents is made available on request to the relevant internal 

and external accident and emergency services.  It shall include the following: 

-  advance  notice  of  relevant  work  hazards,  hazard 

identification 

arrangements,  precautions,  and  procedures  so  that  the  emergency 

services  can  prepare  their  own  response  procedures  and  precautionary 

measures; and 

any available information concerning  specific  hazards arising, or likely to 

arise,  at the time of  an accident  or emergency,  including  information  on 

procedures prepared pursuant to paragraph 4.1 above. 

5.  Derogation  information 

5.1  When making an application  for a derogation  from a prohibition or restriction 

pursuant  to  Article  7(2),  an employer  shall  submit  the  following  information 

to the competent authority : 

V3 

the quantities to be used annually; 

the activities or reactions or processes to be carried out; 

the number of workers liable to be exposed; 

the  precautions  envisaged  to  protect  the  health  and  safety  of  workers 

concerned. 

the  technical  and  organisational  measures  to  be  taken  to  prevent  the 

exposure of workers. 

6. 

Safety equipment maintenance 

Adequate  safety  equipment  must  be  maintained  ready  for  use  and  in  good 

working order at all times. 

Maintenance must be undertaken with due regard to operations. 

7. 

Special health surveillance measures 

The employer shall ensure that any worker exposed to : 

a chemical known to cause sensitisation; 

the following chemical agents: 

Arsenic and its compounds; 

Beryllium; 

Cadmium and its compounds; 

Sa 

Carbon disulphide; 

Chromâtes (Cr6+); 

Cobalt; 

Lead and its compounds; 

Mercury and its compounds; 

Organophosphoric esters; 

Tetrachloroethane; 

shall, if he so wishes, undergo health surveillance. 

Where  biological  monitoring  is  carried  out  it  shall  form  part  of  health 

surveillance.  Where indicated  by the nature of  the risk, biological  monitoring 

shall  be  used  to  reveal  pre-clinical  effects  on  the  health  status  of  workers  in 

order  to  permit  intervention  to  prevent  clinical  deterioration.  The  result  of 

biological monitoring shall not be used to discriminate against the worker. 

Biological  limit values and related  requirements are to be observed  as  part of 

health surveillance. 

Where,  as  a  result  of  health  surveillance,  a  worker  is  found  to  be  suffering 

from  an  abnormality  which  is  considered  to  be  the  result  of  exposure  to  a 

chemical agent,  the employer shall: 

review the safety and health document,  prepared pursuant to Article 3; 

take  into  account  the  advice  of  the  doctor  or  medical  authority  and 

implement  specific  measures  to  eliminate  or reduce exposure,  including 

the possibility  of  assigning  the  worker  to alternative  work  with  a  lesser 

risk of exposure; 

S1 

arrange  continued  health  surveillance  and  provide  for  a  review  of  the 

health  status  of  any  other  worker  who  has  been  similarly  exposed.  In 

such  cases  the competent  doctor  or  medical  authority  may  propose  that 

exposed persons undergo a medical examination. 

The  doctor  or  medical  authority  shall  inform  the  worker  of  the  results  of 

health  surveillance  which  relate  to  him  personally,  including  information  and 

advice  regarding  any  health  surveillance  which  the  worker  should  undergo 

following  the end of exposure. 

8.  Record keeping 

8.1  The  employer  shall  ensure  that  the  safety  and  health  document  prepared 

pursuant to Article 3 contains  sufficient  detail about the information  on  which 

it is based and the risk assessment methods used for the competent authority to 

evaluate  the  assessment  and  the  measures  taken  to  eliminate  or  reduce  any 

risk. 

The safety and health document shall be kept for at least 5  years from  the date 

on which it is made or revised and shall be made available to workers or their 

representatives and to the competent authority on request. 

8.2  Member  States  shall  establish  arrangements  to  ensure  that  for  each  worker 

who  undergoes  health  surveillance  in  accordance  with  the  requirements  of 

Article 9  an individual health record  is  made and kept up-to-date.  The health 

record shall contain a summary of the results of health surveillance carried out 

and of any monitoring data representative of the exposure of  the individual.  It 

shall be  kept,  taking  into account  medical  confidentiality,  in accordance  with 

national laws and practice. 

sz 

The  health  records shall be retained  for  at least 40  years  from  the date of  the 

last  entry.  A  copy  shall  be  supplied  to  the  competent  medical  authority  on 

request.  In accordance with national  laws  and practice  the individual  worker 

shall,  at  his  request,  have  access  to  the  health  record  relating  to  him 

personally. 

In the  case  where an undertaking  ceases  to  trade,  the  health  records  shall  be 

made  available  to  the  competent  authority,  in  accordance  with  national  laws 

and practice. 

9. 

Information  on chemical agents 

9.1  The information on chemical agents to be provided to the worker shall include 

the following  : 

the identity of the agent or agents to which exposure may occur; 

risks to  health  and  safety  arising  from  the  work  activity  or  process  or 

arising from possible exposure at the workplace; 

the  precautions  which  the  employer  has  undertaken  in  order  to  reduce 

risks,  including  information  on  containment  facilities,  safe  storage  and 

handling,  transport and waste disposal within the enterprise; 

the precautions which the worker must take in order to reduce exposure, 

including use of personal protective equipment; 

relevant occupational exposure levels; 

^3 

the  consequence  of  any  foreseeable  abnormal  situation  including  over 

exposure and action to be taken; 

prepared action plans; 

first aid measures; 

fire fighting methods; 

action  taken,  or  to  be  taken,  in  the  case  of  a  spillage  or  an  incident, 

accident or emergency  involving a chemical agent; 

any  restrictions  on  use  of  agents  or  limitation  of  access  to  designated 

areas, including indications on how such areas may be recognised; 

up-to-date information giving the results of measurements of exposure. 

9.2  The  employer  shall  ensure  that  containers  and  pipes  for  chemical  agents  at 

work are : 

in  the  case  of  chemical  agents  covered  by  the  definition  of  dangerous 

substances  or  preparations  in  accordance  with  Directives  67/548/EEC 

and  88/379/EEC  as  amended,  provided  with  safety  signs  in  accordance 

with Directive 92/58/EEC.  Information  shall also be provided either by 

labelling  on  the  container,  or  by  other  suitable  means,  on  the  contents 

and  their  hazards,  the  identity,  and  the  risk  and  safety  phrases  in 

accordance  with  the  criteria  laid  down  in  Annex  VI  of  Directive 

67/548/EEC and in Directive 88/379/EEC; 

^  7 

in the case of  other chemical agents,  marked or otherwise provided  with 

an indication of the nature of the contents. 

9.3  The employer  shall ensure that containers used for chemical  agents  which are 

labelled  at  the  time  of  supply  to  the  employer  shall  retain  the  label  at  the 

workplace while any hazard from the chemical agent remains. 

9.4  The employer shall make available to workers, or workers'  representatives,  on 

request,  any  safety  data  sheet  provided  by  the  supplier  in  accordance  with 

Article  10  of  Directive  88/379/EEC  and  Article  27  of  Directive  92/32/EEC 

or,  where  these  Directives  do  not  apply,  with  a  data  sheet  of  similar  format 

and content containing relevant data. 

9.5  The competent  authority  shall  ensure  that employers  may  obtain  information 

on  chemical  agents  in  order  to  protect  the  safety  and  health  of  workers  at 

work. 

ss 

10.  Limit  Values and Biological  Limit  Values 

10.1  Limit Values (3) for occupational  exposure 

EINECS 

CAS 

Name of 

Limit  Value (6) 

No. 

(1) 

-

No. 

(2) 

Agent 

mg/m3 (4) 

ppm (5) 

-

metallic Lead 

0.15 

-

and its ionic 

compounds 

(1)  EINECS: 

European Inventory of Existing Chemical Substances. 

(2)  CAS: 

Chemical Abstract Service Number. 

(3) 

Measured or calculated in relation to a reference period of eight hours unless 

otherwise stated. 

(4)  mg/tar 

milligrams per cubic metre 

(5) 

ppm 

parts per million by volume in air (ml/m^) 

(6) 

at 20°C and 101,3  KPa (760 mm Mercury pressure) 

10.2  Biological Limit Values 

a)  Lead 

Biological  monitoring  shall,  apart from the exception  mentioned  in point 

l i b ),  include measuring the blood-lead level  (PbB); the biological  limit 

value is: 

SQ 

70 f*g Pb/100 ml blood 

The  method  to  be  used  for 

the  analysis  is  atomic  absorption 

spectroscopy. 

11.  Special Measures for Lead 

a) 

The  biological  monitoring  may  also  include  one  or  more  of  the 

following biological indicators: 

-  delta aminolevulinic acid in urine (ALAU); 

-  zinc protoporphyrin (ZPP); 

-  delta aminolaevulinic acid dehydratase in blood (ALAD). 

The related methods to be used for the analysis of samples are: 

-  ALAU: 

-  ZPP: 

-  ALAD: 

Davis or equivalent method 

Haematofluorimetry  or equivalent method 

European standardised method or equivalent method 

b)  The lead in blood (PbB) measurement may be replaced by that of ALAU 

when dealing with workers who have been subjected  for a period of less 

than one month to risks of high exposure. In this case the following  limit 

values shall be applied for ALAU: 

20 mg/g creatinine 

s ? 

c) 

Biological  monitoring  shall be carried out at least every  six  months; this 

frequency  may be reduced to once a year where at the same  time: 

- 

the  results  of  the  measurements  for  individuals  or  for  groups  of 

workers  have  shown,  on  the  previous  two  consecutive  occasions  on 

which  monitoring  was carried  out,  a  lead-in-air  concentration  higher 

than 0,075  mg/m^ and lower than 0,1  mg/vn?. 

- 

the PbB level of any «individual worker does not exceed 50 fig Pb/100 

ml blood. 

ANNEXA 

IMPACT ASSESSMENT 

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

Title of proposal: 

Proposal for a Council Directive on the protection 
of  the health and safety  of  workers  from  the risks 
related to chemical agents at work 

Document  reference  number: 

HK/seh/consoli/100.6 

The proposal 

1. 

Taking account  of the principle  of subsidiarity,  why is  Community  legislation 
necessary  in this area and  what are its main  aims? 

a) 

Reason for Community action 

Exposure to chemical  agents occurs in every  aspect of  daily  life.  Over 
100,00&hemicals are included in the European Inventory of Existing  Chemical 
Substances  (EINECS).  Many  of  these  chemicals  have  dangerous  properties 
which  can  adversely  affect  the  health  and  safety  of  workers  at  work.  It  has 
been estimated  that accidents  and ill  health at work account  for  approximately 
7%  of  all  social  security  expenditure  within  the  EC,  affecting  10  million 
workers  every  year  at  an  overall  cost  of  20  billion  ECU. 
It  is  clear  from 
information  in Member States that a significant  proportion of  the ill-health that 
It  is 
is  caused  by  work  activities  is  due  to  exposure  to  chemical  agents. 
therefore  important  that suitable  precautions  should  be  taken at  the  workplace 
to prevent these problems. 

The proposal does not breach the principle of  subsidiarity,  because it is 
only  by  Community  action  pursuant  to  Article  118A  of  the  Treaty  that  a 
minimum level  of  protection  for  workers  from  the risks related  to exposure  to 
chemical  agents  can  be  assured  in  all  Member  States.  Such  action  will  also 
avoid  any  distortion  in  the  area of  competitiveness  by  preventing  the  unequal 
application  of  minimum  standards  for  worker  protection  in  one  or  other 
Member States. 

se 

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

b) 

Objectives of the proposal 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

to  establish  minimum  requirements  for  the  protection  of  workers 
against  risks  to  their  health  and  safety  arising  from  all  chemical 
agents at work; 

to  consolidate,  update  and  adapt  existing  provisions  in  relation  to 
chemical  agents in  the light of  current knowledge  and  to align  them 
with the measures established in Directive 89/391/EEC; 

to incorporate into the new text the individual Directive  82/605/EEC 
relating  to  exposure  to  metallic  lead  and  its  compounds  and  the 
Directive  88/364/EEC  relating  to  the banning  of  certain  agents  and 
certain work activities; 

to  establish  additional  requirements  with  respect  to  improving  the 
protection  of  workers  against  the  risks  arising  from  activities 
involving chemical agents; 

to remove ambiguities in the requirements of  existing  Directives and 
uncertainty in the extent of their application; 

to clarify  the Community provisions  relating  to the health and  safety 
of  workers exposed  to chemical  agents,  and to provide an  improved 
basis for the provision of information to workers; 

to  ensure  that  all  precautionary  measures  at  work  are  based  on  a 
proper assessment of risks arising  from  the way  chemical  agents are 
used  and  that  measures  to  afford  protection  take  account  of  the 
features  of  the  workplace,  the  activity,  the  circumstances  and  any 
specific  risk.  In  this  way,  the  measures  taken  can  properly  reflect 
the  scale  of  risk,  the  appropriate  precautions  and  the  size  of  the 
undertaking without unnecessarily imposing burdens on employers; 

(h) 

to  render  more  explicit  the  existing  alignment  of  Community 
provisions  with  the  ILO Convention  No.  170  (*)  and  its  associated 
Recommendation No.  177 on Chemical Agents at work; 

(1) 

Convention No 170 concerning safety in the use of chemicals at work, adopted by the 
International Labour Conference at its 77th session, Geneva, 25 June 1990 

go 

(i) 

to ensure that the Directive on Carcinogens (90/394/EEC)  remains in 
force,  and  is  excluded  from  this  text,  as  it  contains  specific 
additional requirements for carcinogenic chemical agents. 

The impact on business 

2, 

Who will be affected  by the  proposal? 

•  which sectors of business 

•  which  sizes  of  business  (what  is  the  concentration  of  small  and  medium 

sized firms) 

•  are  there  particular  geographical  areas  of  the  Community  where  these 

businesses are found 

The proposal covers all enterprises  that  manufacture  or use chemicals.  It will 
apply  to  enterprises  in  manufacturing,  construction,  agriculture  and  to  some 
degree in services,  including public services. 

The impact on businesses will depend on the number of chemicals used and the 
number of exposed workers. 

Of the enterprises within the scope of  the Directive approximately  40-60%  are 
expected  to  be  SME's  (less  than  about  75  employees).  It  is  not  possible  to 
precise  about  the  number  and  proportion  of  SME's  because  the  data  on  their 
use of  chemicals  do not exist.  Consequently  it  is  not possible  to  say  whether 
the impact will be greater on SME's in general as opposed to larger firms. 

3. 

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

There  are  few  additional  obligations  on  employers  because  most  of  the 
requirements  have  already  been  established  by  previous  Directives  for  the 
protection  of  the  health  and  safety  of  workers  at  work.  This  text  amplifies 
these existing general provisions as they apply to chemical agents. 

Examples of  this amplification  of  the framework  Directive  89/391/EEC  are to 
be  found  in  these  parts  of  the  proposal  dealing  with  the  assessment  of  risk, 
protection and prevention  measures,  control  of  exposure,  plan of  action  in the 
case of  an emergency  and information  to and consultation  and participation  of 
workers. 

The provisions on Health surveillance too which specify  those chemical  agents 
where health  surveillance is considered  to be necessary are an amplification  of 
the framework Directive 89/391/EEC  in this case Article 14. 

el 

The  text  also  consolidates  some  specific  requirements  again  already  in 
existence,  e.g.  prohibition of  use of certain chemical agents or work activities, 
requirements concering lead and record keeping. 

The obligation to draw up an inventory of chemical agents used at work can be 
seen  as  an  amplification  of  the  requirement  in  the  framework  Directive 
89/391/EEC  for making a risk assessment at work.  It is a logical extension  of 
this  requirement  which  enables  the  Community  to  carry  forward  the 
requirements of ILO convention  170 and its associated recommendation  177 on 
chemicals at work. 

4. 

What economic  effects  is the proposal  likely to  have? 

•  on employment 

•  on investment and the creation of new businesses 

•  on the competitive position of businesses 

The provisions concerning  health surveillance  (Art.  9  and Annex  paragraph  7) 
are  in  addition  to  current  requirements  and  will  have  some  impact  in  all 
Member  States,  with  the possible  exception  of  France.  The  most  significant 
impact  is  expected  for  enterprises  in  Denmark,  Greece,  Ireland,  Netherlands 
and United Kingdom,  where few  such provisions exists today. 

(Health 
Financial  calculations  have  been  possible  for  Article  9  only 
surveillance).  A  partial  estimate,  based  on  current  costs  for  between  8-30 
chemical agents in each Member State have been made, covering  31 percent of 
the  Community's  employed  workers  (Denmark,  Ireland,  Netherlands,  United 
Kingdom).  This showed  additional costs of  at least  100-120  million  ECU per 
year for 22 originally listed agents on the basis of data from these five Member 
States.  With  the  reduction  in  the  size  of  the  list  from  22  to  10,  for  those 
chemical  agents  requiring  health  surveillance,  the  overall  cost  for  the 
implementation  of  Article 9  can be reduced  to approximately  50  million  ECU 
on a pro rata basis. 

The cost per health examination  varies  widely,  both according  to the agent in 
question  and  according  to  the  cost  level  in  Member  States.  The  lowest 
minimum cost reported  is 20 ECU per examination  the  highest  cost  130 ECU 
(both including biological  monitoring). 

The cost per worker is  likely  to be a little  higher in  small  enterprises  because 
larger  enterprises  may  be  able  to get  discounts  on  laboratory  tests,  etc.  The 
variation relative to the size of  the enterprise is expected  to be  much  narrower 
than the variation between Member State price levels.  The aggregate costs are 
unlikely  to  have  any  measurable  impact  on  employment,  investment  or  the 
creation of new businesses. 

G  Z, 

The requirement in Article 3(2)  for employers to keep a list of chemical  agents 
used is expected to have only a minor economic impact. 

5. 

Does  the proposal  contain  measures  to  take  account  of  the  specific  situation 
of small and  medium  sized firms  (reduced or different  requirements  etc.)? 

The  intention  behind  the  proposal  is  to  create  acceptable  minimum  level  of 
irrespective  of  the  size  of  the  employers 
protection  for  all  workers, 
undertaking. 

For chemical  agents  which  have been  the subject of  specific  evaluation  within 
the  Community  as  part  of  the  process  of  authorisation  for  placing  on  the 
market,  e.g.  for  plant  protection  products,  this  evaluation  and  any  related 
labelling  or  safety  instructions  will  often  provide the basis  for a  major part of 
the work assessment under this Directive.  What has to be done,  in addition,  is 
an assessment  of  the way  in  which  the hazards of  the chemical  agents  interact 
with other aspects of the workplace and the methods of use. 

Only  one  Article  (health  surveillance)  obliges  the  employer  to  use  a  specific 
method.  The remaining  Articles define  the goals to achieve,  but the employer 
can  choose  between  various  methods  to  reach  this  goal.  This  gives  him  the 
maximum  possibility  to  choose  the  methods  suited  to  the  workplace,  the 
technology  or the size of the undertaking. 

Consultation 

6. 

List  the  organisations  which  have  been  consulted  about  the  proposal  and 
outline  their  main  views. 

The  opinion  of  the  Advisory  Committee  on  Safety,  Hygiene  and  Health 
Protection  at Work  has been  obtained  on  the proposal.  The  Commission  has 
taken due note of  the Committee's opinion in preparing the text now  submitted 
to  the  Council,  in  particular  in  relation  to  the  procedure  for  setting  limit 
values,  the  requirements  for  the  assessment  and  for  record  keeping,  the 
strengthening  of  the provisions  relating  to  safety,  and  the limit  value  for  lead 
in air, which remains unchanged  from  the limit value in Directive  82/605/EEC 
on lead. 

ISSN 0254-1475 

COM (93) 155 final 

DOCUMENTS 

EN 

Catalogue number : CB-CO-93-179-EN-C 

ISBN 92-77-54601-8 

Office for Official Publications of tbe European Communities 

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