Proposal for a COUNCIL DIRECTIVE on the control of major- accident hazards involving dangerous substances (COMAH)
Date: 1994-01-26
Institutions: European Commission
Subjects: dangerous substance, environmental risk prevention, exchange of information, industrial hazard, public health, safety standard

COMMISSION  OF THE EUROPEAN  COMMUNITIES 

COM(94)  4  final 

Brussels,  26.01.1994 

94/0014  (SYN) 

Proposal  for  a 
COUNCIL  DIRECTIVE 
on  the  control  of  major-accident  hazards  involving  dangerous  substances  (COMAH) 

:  '.-H? 

(presented  by  the  Commission) 

*  ••'%&! 

••%m 
F  Vï:f? 

•iJM 

EXPLANATORY  MEMORANDUM 

INTRODUCTION 

1- 

Community  Policy  Context 

Council  Directive  82/501/EEC  of  24  June  1982  on  the  Major  Accident  Hazards  of  Certain 
Industrial  Activities(1) was introduced  in response to  accidents like Flixborough  in  1974, Beek in 
1975  and  Seveso  and  Manfredonia  in  1976.  The  action  taken  by  Member  States  in  the  field  of 
industrial  risks  up  to  then  was  fragmented.  Furthermore,  Community  action  was  required  to 
ensure  equal  treatment  of  the  problem  in  all  Member  States. 

The aim of the Directive was to ensure that  all Member  States introduced  legislation  in this area 
in accordance with the objectives of the Directive, and that the Competent  Authorities  established 
procedures  to  implement  its  provisions.  The  detailed  requirements  under  the  Directive  covered 
measures relating to prevention, preparedness and response to Major  Accidents as they affect  man 
and the  environment  both  inside  and  outside  the  establishments  concerned. 

The Council  in its accompanying  resolution  concerning the Fourth European  Community  Action 
Programme  on  the  Environment^  called  for  more  effective  implementation  of  the  Directive, 
greater  exchange  of  information  between  Member  States  and  review,  including  a  possible 
widening  of  the  scope. 

The  Council,  on  24  November  I986(3),  invited  the  Commission  to  review  the  Community 
measures for  the prevention  of Major  Accidents  and the  limitation  of their  consequences  and, if 
necessary,  to present  appropriate  proposals. 

During the adoption procedure for the first amendment^ (87/216/EEC) the Commission gave the 
assurance  that  it  intended  to  propose  a fundamental  revision  of  Annexes  I,  II  and  III. 

Furthermore  during  the  adoption  of  the  second  amendment  of  the  Directive  (88/610/EEC)  on 
24 November  1988(5) the  Council  in  its accompanying  statement  asked  the  Commission  to  give 
priority  to  a re-examination  of  the  Directive,  particularly  the  application  Annexes. 

In its Resolution  of  16 October  1989(6) on guidelines to reduce technological  and natural  hazards 
the Council invited the Commission to consider ways of including land use planning controls into 
the  Directive  taking  into  account,  particularly,  the  consequences  of  the  accident  at Bhopal,  and 
the means towards achieving mutual  understanding  and harmonization  of national principles  and 
practices  regarding  safety  reports. 

0) 

(2) 

(3) 

(4) 

(5) 

(6) 

O J N o L 2 3 0,  5.8.1982,  p.  1. 
OJNo  C  328,  7.12.1987,  p. 3. 
1121st  Session  of  the  Council  (Environment). 
O J N oL  85, 28.3.1987, p. 36. 
O J N o L 3 3 6,  7.12.1988,  p.  14. 
O J N oC  273, 26.10.1989, p.  1. 

The  5th  Environmental  Action  Programme,  "Towards  Sustainability:  A  European  Community 
Programme of Policy and Action in Relation to the Environment and Sustainable Development"(7), 
proposes  that, for  the period  1993-2000, two  common  features  of  the programme,  including  the 
control  of  industrial  risks, are: 

the  involvement  of  all  levels  of  society  in  the  spirit  of  shared  responsibility,  and, 

in  order  to  ensure  that  Community  measures  on  the  environment  are  more  effectively 
implemented,  cooperation  procedures  between  the  Commission  and  the  Member  States 
should  be  further  improved. 

2. 

Need  for  action  at  Community  level 

2.1.  What  are  the  objectives  of  the  action  envisaged  in  relation  to  the  Community's 

obligations? 

The objective  of this proposal  is to improve the effectiveness  of the current legislative  framework 
regarding  the  prevention  of  major  accidents  and  thus  ensure  a higher  level  of  protection  of  man 
and  the  environment.  To  achieve  this  objective  the  proposal  seeks  to  replace  Directive 
82/501/EEC  with  a new  Directive  which  carries  forward  the  essential  principles  of  the  existing 
Directive,  but  also  incorporates  additional  measures  which  reflect  current  good  practice  in  risk 
management,  as  well  as provisions  to  improve  the  effectiveness  of  implementation. 

The provisions  of  the  original  Directive  have  proved  successful,  particularly  with  respect  to  the 
technical  aspects  of  prevention,  preparedness  and  response.  Nevertheless,  since  the  adoption  of 
the Directive,  over  130  major  accidents  have  occurred  in  the  Community  and  many  more  have 
occurred  around  the  world. 

The  primary  need  when  the  original  Directive  was  adopted  was  to  stimulate  action  by  Member 
States  on  the  basic  aspects  of  a  major  hazard  risk  control  policy.  The  purpose  of  this  proposal 
is  to  refine  and  supplement  this  policy  in  the  light  of  experience  and  developments,  and  to 
provide  tools  and  guidance  to  increase  the  consistency  of  implementation  of  the  Directive. 

The proposal  contributes  to  the realization  of  Article  130r  of  the Treaty  which  contains  specific 
provisions  on  the  Community's  role  in  environmental  protection;  in  particular  the  preservation 
and protection  of the quality  of the environment  and the protection  of human  health. It  is based 
on  the  principles  of  precautionary  and  preventive  action,  that  environmental  damage  should  be 
rectified  at source and that the polluter  should pay. It aims at a high  level  of protection  and takes 
account  of  the  diversity  of  situations  in  the  various  regions  of  the  Community. 

(7) 

COM(92)  23  final. 

2.2. 

Is  the  action  envisaged  an  exclusive  competence  of  the  Community  or  a  shared 
competence  with  the  Member  States? 

The  envisaged  action  is  not  within  the  exclusive  competence  of  the  Community.  However,  the 
proposal  respects  the  principle  of  subsidiarity  contained  in  Article  3b  of  the  Treaty.  The  text 
proposes  the  measures  necessary  to  prevent  major  accidents,  i.e.  those  potentially  capable  of 
having  significant  and  wide  effects;  minor  accidents  with  only  limited  local  effects  are  not 
addressed.  The  essential  policy  provisions  for  the  control  of  major  hazard  risks  are  defined  at 
Community  level,  but  the  choice  of  the  means  for  implementing  these  provisions  is  left  to  the 
relevant  national  and  local  authorities  in  Member  States. 

2.3.  What  is the Community  dimension  of the problem? What  solution  has been  in force  until 

now? 

This  proposal  is  primarily  concerned  with  the  prevention  of  low  frequency,  high  consequence 
accidents.  Major  accidents  such  as  Seveso,  Flixborough  and,  more  recently,  Bhopal  and  Basel 
have  shown  that  the  costs,  both  economically  and  environmentally,  of  only  one  such  major 
accident  are  significant,  not  just  for  the  industrial  establishment  concerned,  but  also  for  the 
Authorities  of  the  State  and  on  a  wider  scale  for  the  International  Community.  Indeed  the 
potential  severity  of  accidents  arising  from  the  sites  concerned,  is  such  that  they  could  have 
transboundary  implications  and  thus  affect  the  environment  in  adjacent  Member  States. 

It  is often  difficult  to  assess the  actual  costs of the  type  of  incidents  addressed  by  this  proposal. 
The  calculations  need  to  consider,  amongst  other  things,  the  loss of  lives,  long  term  damage  to 
health  (of  man  and the  environment), property  damage, loss of  production,  loss of  amenity,  cost 
of  response  and  remedial  action.  Nevertheless  cost  estimates  have  been  made  for  some  of  the 
high  profile  incidents.  The  cost of property  loss  alone  for  three of  the  major  incidents that  have 
shaped  Community  policy  are  estimated  (at  1989  costs)  as: 

Flixborough  explosion  (UK  -  1974) 

ECU  110  million 

Seveso  explosion  (Italy  -  1976) 

ECU  72  million 

Basle  warehouse  fire  (Switzerland  -  1986) 

>ECU  26  million 

Major  hazard  premises  are  found  in  all  Member  States.  The  figures  given  below  are  the  latest 
available  to  the  Commission  and  represent  the  numbers  of  establishments  covered  by  the  more 
stringent requirements of  Directive 82/501/EEC which require the production  of a detailed  safety 
report. 

Limited  information  is available  from  the Member  States on  the  current  state of  implementation 
of  Council  Directive  82/501/EEC  as  amended.  This  is  mainly  due  to  the  fact  that  the  original 
powers  granted  to  the  Commission  were  not  sufficient  to  require  the  information  needed  to 
effectively  monitor  the practical  implementation  of the  Directive.  This is rectified  in the  current 
proposal. 

The  state  of  transposition  of  Directive  82/501/EEC  (as  amended)  within  the  Community  is  as 
follows: 

BELGIUM 

The  second  amendment  to  Council  Directive  82/501/EEC,  Directive  88/610/EEC  has  been 
transposed  into  law  by  Royal  Decrees  of  7  February  1990  and  16  May  1990.  Information 
available  for  the  end  of  1992  indicated  that  a  total  of  87  enterprises  were  covered  by  the 
provisions  made  as  a  result  of  Article  5  of  Council  Directive  82/501/EEC  as  amended.  Public 
information  campaigns  have been  carried  out. 

DENMARK 

Transposition  of  the  second  amendment  is  complete  by  virtue  of  Statutory  Order  No  520  of 
5 July  1990. Information  available up to June  1993 indicated that 38 establishments were covered 
by  the  requirements  of  the  amended  Directive. 

FRANCE 

Transposition  of the second amendment has been carried out by administrative  instruction.  Public 
information  is already  freely  available  and the public have  access to the  safety  report  produced, 
with  the  exception  of  certain  confidential  information.  Information  to  June  1993  indicated  that 
377 establishments were covered by the provisions of Article  5 of Council Directive  82/501/EEC 
including  the  additional  establishments  covered  as  a  result  of  the  second  amendment. 

FEDERAL  REPUBLIC  OF  GERMANY 

Transposition  of  the  second  amendment  has  been  carried  out  by  the  amended  version  of  the 
Twelfth  Order  implementing  the  Federal  Emission  Control  Act  (Hazardous  Incidents  Order)  of 
20  September  1991.  Approximate  information  received  up  to  July  1990  indicated  283 
establishments  were  covered  by  the  provisions  of  Article  5  of  Council  Directive  82/501/EEC. 
Since  implementation  of  the  second  amendment  and  re-unification  of  Germany,  up  to  date 
information  is not  available. 

GREECE 

No  up to  date information  is  currently  available  on  the  transposition  of  the  second  amendment. 
Information  available up to the end of  1992 indicates that 34 establishments  were covered by the 
provisions  of  Article  5 of  Council  Directive  82/501/EEC. 

IRELAND 

The transposition of the second amendment was completed in January  1992. Information  received 
for  the  end  of  1992  indicated  that  20  establishments  were  covered  by  the  requirements  of 
Article  5 of  Council  Directive  82/501/EEC  (as  amended). 

ITALY 

Work  to  prepare  for  the  transposition  of  the  second  amendment  has  been  underway  for  some 
time  but  no  up  to  date  information  is  available.  Information  received  for  the  end  of  1992 
indicated  that  329  establishments  were  covered  by  the  requirements  of  Article  5  of  Council 
Directive  82/501/EEC. 

LUXEMBOURG 

Work  is  completed  to  transpose  the  requirements  of  the  second  amendment  via  a Regulation  of 
19 July  1991. Information  received  for  the  end  of  1992  indicates  that  four  establishments  were 
covered  by  the  requirements  of  Article  5  of  Council  Directive  82/501/EEC.  No  further 
establishments  have  been  notified  as  a  result  of  the  second  amendment. 

NETHERLANDS 

Transposition  of  the  second  amendment  has  already  been  carried  out  by  changes  to  law  and 
guidelines  issued to  local  and  regional  authorities. Information  to the  end of  July  1990  indicated 
79  establishments  were  covered  by  Article  5  of  Council  Directive  82/501/EEC.  No  further 
information  was  available  on  the  number  of  establishments  brought  in  as  a  result  of  the  second 
amendment. 

PORTUGAL 

Transposition  of the second amendment has begun. Information  for  the end of  1992 indicated that 
45 establishments  were  covered by  Article  5 of  Council  Directive  82/501/EEC. No  further  up to 
date  information  is  available. 

SPAIN 

Transposition  of  the second  amendment  was completed  by Royal  Decree  952/1990.  Information 
for  the  end  of  1992  indicated  approximately  270  establishments  were  covered  by  Article  5  of 
Council  Directive  82/501/EEC. 

UNITED  KINGDOM 

Transposition  of  the  second  amendment  was  completed  by  the  Control  of  Major  Hazards 
(Amendment)  Regulations  1990  which  came  into  force  on  31  December  1990. Information  for 
the end of  1992 indicated  that 298 establishments  were covered by Article 5 of Council  Directive 
82/501/EEC  (as  amended). 

Currently  the  major  hazard  risks  in  these  establishments  are addressed  by  the implementation  of 
Directive  82/501/EEC  supplemented  by  other  provisions  introduced  at the  initiative  of  Member 
States. 

It  is  clear  from  the  information  provided  voluntarily  by  Member  States,  exchanges  at  the 
Committee  of  Competent  Authorities  and  other  studies,  that  because  the  original  Directive  was 
framework  in nature it has resulted in variable approaches with unacceptable differences  between 
Member  States  in  the  level  of  protection  for  man  and  the  environment  against  major  hazard 
risks. 

Issues  where  this  is  the  case  include  the  contents  of  Safety  Reports  (and  the  response  by  the 
Competent  Authorities  to  their  receipt)  and  the  inspection  regime  established  to  regulate  major 
hazard  sites. 

The  terrible  accident  at Bhopal  confirmed,  to  all  those  involved  with  Major  Accident  controls, 
the  possible  dangers  to  man  and  the  environment  simply  because  of  the  proximity  of  the 
establishments  concerned  to  sensitive  areas.  It  led  to  the  Council  Resolution  of  1989  calling  on 
the  Commission  to  consider  ways  of  including  land  use  planning  controls  in  the  Directive. 
Several  studies  of  Siting  and  Land  Use in  individual  Member  States  and  around  the  world  have 
concluded  that  specific  land  use  measures  are justified  even  from  a  purely  economic  point  of 
view  by  the  prevention  of  major  accidents  with  their  high  resulting  social  and  industrial  costs. 

The long term  aim of any siting and land use policy  is obviously  the separation  of major  accident 
hazards and centres of population  or sensitive environments. The industrial  growth  of Europe has 
resulted in many areas where existing industry  is in close proximity  to such sensitive areas. Some 
Member  States  have  existing  siting  and  land  use  legislation.  They  use  a  number  of  different 
approaches  to  the  problem  and  this  proposal  addresses  these  differences  by  concentrating  upon 
the  common  features  found  in  existing  requirements, policy  creation,  and  information  exchange. 
This  is backed  up  with  a provision  for  the  development  of  Community  guidelines  if  necessary. 

Analysis of the major  accidents  reported  in the  Community  indicates that, in the majority  (90%) 
of  cases,  management  error  was  the  underlying  cause.  This  error  can  manifest  itself  as 
deficiencies  of  organization,  inadequate  training,  or  simply  failing  to  take  into  account  the 
possibility  of  human  error. 

The  existing  Directive  concentrates  on  the  technical  aspects  of  risk  control  and  does  not 
adequately  deal  with  the  management  and  human  factors  issues.  This  emphasis  is  reflected  in 
Member  States  legislation  in  this  area. 

In  recognition  of this the proposal  includes  improved  consideration  of  management  systems  and 
human  factors.  The  main  changes  relate  to  the  new  concept  of  an  internal  Major  Accident 
Prevention Policy (MAPP) for all establishments covered by the Directive. This policy now forms 
the  basis  of  the  requirements  for  any  establishment  where  the  lower  threshold  is  exceeded  and 
is  enhanced  by  a  requirement  to  implement  management  systems  as  appropriate  to  control  the 
major  accident  hazards  identified  by  the  operator. 

A  key  requirement  of  the  proposal,  as  in  the  existing  Directive,  lies  in  the  production,  by  the 
larger  establishments  covered  by  the  proposal,  of  a  Safety  Report  and  its  submission  to  the 
Competent  Authorities.  However  this  will  in  addition  have  to  include  consideration  of 
management  systems  and  organization  of  the  establishment. 

Based  on  the  experience  of  Member  States  the  contents  of  the  Report  have  been  more  clearly 
defined  although  its  presentation  is  made  more  flexible  to  take  into  account  the  different  types 
of industry  covered by the Directive  and other legislation  which  may  require  similar  information 
to  be  provided  to  the  Authorities  in  the  Member  States.  To  take  these  factors  into  account  the 
operator  will be able to present the safety  report in the most  appropriate  format  for the particular 
establishment  concerned,  combining  other  reports  or  parts  of  other  reports,  provided  a  clear 
description  of  the  establishment  is presented,  and  the  objectives  of  the  report  are  maintained. 

A fundamental  tenet of the Community's  environmental  policy  is the provision  of information  to 
the  public  to  enable  them  to  both  understand  and,  if  necessary  influence  the  action  and 
performance  of  companies.  The  existing  Directive  does  not  actively  contribute  to  this.  The 
provision  of  information  is limited  to  a "need  to know"  basis  - in the  event  of  a major  accident. 
This gap is addressed in the current proposal by requiring the  Safety  Report to be made available 
to  the  public.  There  are  also  new  rights  for  the  public  to  participate  in  relevant  procedures  and 
debate on siting and land use, and control policies produced by the authorities. However the need 
to  keep  certain  information  confidential  is  recognised  in  an  identical  fashion  to  Directive 
90/313/EEC(8). 

inspection  practices  by  introducing  clear 
The  proposal  addresses  the  issue  of  unequal 
responsibilities  and  duties  of  the  inspection  system  created  by  the  Competent  Authority  backed 
up by new duties and powers to prohibit  establishments  if necessary,  and minimum  standards  for 
the  inspections  themselves. 

Under  the present  Directive  82/501/EEC  no  specific  procedure  is  established  for  easy  evolution 
of  the  control  measures  required  or  the  harmonization  of  criteria  for  the  key  elements  of  the 
Directive.  This  is  addressed  in  the  proposed  text  by  providing  for  the  adoption  of  Community 
criteria  for  the  essential  parts  of  the  control  system.  These  requirements  or  guidance,  it  is 
foreseen,  could  be  developed  by  the  Commission  assisted  by  a Committee  of  representatives  of 
Member  States. 

The procedure  proposed  is  designed  to  produce,  where necessary,  greater  harmonization  at high 
levels  of  protection. 

Studies  undertaken  by  the  Commission  indicate  that  only  47% of  the  chemicals  currently  listed 
in  Annex  III  of  the  Directive  are  in  use  in  the  Community  industries  covered  by  the  Directive. 
Changes to industrial  processes have resulted  in the need to re-examine the use of lists of  specific 
industrial  activities  and  chemicals  as  the  basis  for  application.  Such  a  system  is  inflexible  in 
dealing  with  both  the  elimination  of  redundant  processes  and  chemicals  and  the  introduction 
of new ones. Further, the use of  a specific  list of industries  and the exclusion  of others where the 
hazards  are  identical  is not justifiable  in  technical  or  policy  terms. 

(8) 

O J N oL  158, 23.6.1990, p.  56. 

The  method  of  application  in  the  proposed  new  Directive  has  therefore  been  amended  to  apply 
the provisions wherever dangerous substances are present in sufficient  quantities to create a Major 
Accident  Hazard.  This  is  more  flexible  and  removes  any  distortions.  The  remaining  exemptions 
apply  only  to  areas  where  existing  legal  provisions  are  equal  to  the  current  proposals  or,  where 
the industry  concerned has special problems or needs with  respect to major  accident controls (e.g. 
in  the  case  of  pipelines,  transport  and  the  extractive  industries). 

2.4.  What  is the  most  effective  solution,  comparing  the  means  of  the  Member  States  and  the 

Community? 

Industry  is subject  to various pressures to improve  environmental  performance  and  control of the 
hazards  and  risks  it  inevitably  creates.  These  pressures  include  industry's  own  sense  of 
responsibility  (as illustrated  by the chemical  industry's Responsible  Care programme)  as well  as 
a variety  of stakeholders  including,  amongst  others, employees, neighbours,customers,  suppliers, 
shareholders  and  financiers.  In  recent  years  the  insurance  industry,  in  particular,  has  begun  to 
take  a more  active  and  influential  role  in  this  area. 

However  pressure  from  such  sources  is not  equally  applied  across  the  Community  and  is not  in 
Indeed  the  awareness  of  active 
itself  sufficient  to  give  public  reassurance  in  this  area. 
stakeholders 
legislation  or  more  effective 
implementation  of  existing  legislation. 

through  calls  for  more 

is  often  expressed 

As  far  as  Major  Hazards  are  concerned  the  most  effective  solution  is  an  action  taken  at 
Community  level. Only the Community  can alter the approach followed  to date by modifying  and 
complementing  the  existing  legislation  covering  industrial  risk,  particularly  by  emphasising  the 
policy of prevention of major  accidents by a more active system of management  and  organization 
in  relevant  establishments,  and  the  development  of  Community  criteria  for  the  most  important 
aspects  of  the  control  system.  This  approach  has  been  endorsed  by  the  Council  in  the  various 
resolutions  which  initiated  this  review  (referred  to  above)  calling  on  the Commission  to  modify 
Directive  82/501/EEC  as  appropriate  and  to  improve  the  effectiveness  of  its  implementation. 

2.5.  What  is  the  value  added  brought  about  by  the  action  envisaged  to  the  Community  and 

what  would  be  the  cost  of  inaction? 

The  action  envisaged  in  the proposal  is  to  further  improve  the  systems  in  place  in  industry  and 
the  competent  authorities  to  control  major  accident  hazards  and  thus to  reduce  the  likelihood  of 
their  occurance,  and,  where  they  do  occur, 
to  minimise  their  consequences  for  man  and  the 
environment.  It  also  seeks  to  simplify  the  Directive's  application  criteria  and  make  it  more 
flexible  in  response  to  the  changing  nature  of  industry.  Failure  to  do  this  would  result  in  an 
unacceptably  different  level  of  protection  in  Member  States  and  would  mean  that  best  risk 
management  principles  are  not  applied  equally  across  the  Community. 

2.6.  What  action 

is  available  to  the  Community  (recommendation,  financial  support, 

legislation,  etc.)? 

In  order  to  modify  or  repeal  an  existing  Directive,  legislation  at  Community  level  is  necessary. 

2.7. 

Is uniform  regulation  necessary  or is a Directive setting out the general  objectives  leaving 
the  detailed  execution  to  the  Member  States  enough? 

The  initiative  for  the  review  of  Directive  82/501/EEC  lay  inter  alia  in  concerns  about  the 
effectiveness  of  its  implementation.  However  the  principles  of  subsidiarity  and  proportionality 
suggest  that  a modified  Directive  is preferrable  to  a  regulation. 

Throughout  the  proposal  these  principles  have  been  met  as  follows: 

-  the  proposal  sets  out  the  objectives  and  requirements  needed  for  harmonization,  where 
necessary,  to  achieve  a  high  level  of  protection  for  the  environment,  whilst  maintaining 
implementation  at  the  appropriate  lower  level,  adapted  for  national  conditions; 

-  the  objectives  to  be  achieved  and the  matters  to  be  considered  are  clearly  identified  for  such 
things  as  safety  reports,  emergency  planning,  and  inspection  systems,  whilst  responsibilities 
for  the practical  implementation  remain  at  the  lowest  appropriate  level; 

-  the  concrete  application  and  management  of  the  requirements  are  left  to  the  national  or  even 
local  level;  in  particular,  safety  reports  are  produced  by  the  operator  and  assessed  by  the 
Competent  Authority,  Emergency  Plans  are produced  by  the  operator  or  local  authority  and 
assessed by the Competent  Authority,  and information  of the public is the responsibility  of the 
local  authorities; 

3.  International  situation 

The Commission  and the Member  States have been  actively  involved  in many  international  fora, 
including  the  OECD,  Rhine  Commission,  International  Labour  Office  and  United  Nations, 
developing  codes  of  practice,  conventions,  and  recommendations  relating  to  major  accident 
controls. In these  fora the original  format  of the  Council  Directive  of 24 June  1982 on the  major 
accident  hazards  of  certain  industrial  activities  has  been  an  important  reference  as  well  as  the 
emerging proposals from  the review of that Directive. However in order to remain at the  forefront 
of  industrial  risk  policy,  the  Community  now needs  to update  the Directive  to  take into  account 
the experience in Member States in implementing Directive 82/501/EEC and other developments, 
internationally  and  within  the  Community,  dealing  with  major  hazard  risk  management. 

The  most  active  international  fora  in  the  field  have  been  the  United  Nations  Economic 
Commission  for  Europe  (UNECE),  the  International  Labour  Office  (ILO)  and  the  Organization 
for  Economic  Cooperation  and  Development  (OECD). 

In  1992  the  UNECE  completed  work  on  a  Convention,  signed  in  Helsinki,  covering 
Transboundary  Major  Accidents.  Although  the  Convention  is  without  prejudice  to  other  more 
stringent  measures  taken  by  signatories,  it  does  include  such  matters  as Land  Use  Planning  and 
increased  emphasis  on  Safety  Management  Sytems  all  of  which  will  be  implemented  by  the 
equivalent  provisions  contained  in  this  proposal. 

10 

The  ILO  published  a  Code  of  Practice  on  Major  Accidents  in  1991.  Member  States  and  the 
Commission  were  also  involved  in  consultation  a negotiations  on  a proposed  Convention  which 
was  adopted  in  June  1993. The  Convention  covers pipelines  and the  extractive  industries,  which 
are  not  part  of  this  proposal. 

The  OECD  has  recently  completed  a  programme  of  work  on  major  accidents  including  the 
publication  of  a  number  of  Environment  Monographs  following  workshops  and  the  conclusion 
of  a  Recommendation.  The  Commission  and  Member  States  have  actively  participated  in  this 
programme.  Subjects  covered  included  "the  role  of  human  factors  in  plant  operations",  "good 
management  practice",  "information  to the public  and  the role  of  workers  in  accident  prevention 
and  response",  and  "the  role  of  public  authorities  in  preventing  major  accidents  and  in  major 
accident  land  use planning". Information  from  this work  is included  in this proposal,  particularly 
those  aspects  relating  to  management  systems  and  human  factors. 

The  USA,  Canada,  Sweden,  and  Japan  have  been  particularly  active  in  these  fora,  notably  the 
OECD,  and have  all  agreed  to  adopt  approaches  to  major  accident  control  based  upon  the  ideas 
expressed  in  the  documents  produced.  The  legislation  in  the  Nordic  States  is  comparable  to  the 
current Council Directive 82/501/EEC whilst the USA, Canada and Japan traditionally  take a less 
regulatory  approach  - although  the former  have recently  proposed  Federal  Regulations  modelled 
on Directive  82/501/EEC. Many  of  the countries  in Eastern  Europe  with  economies in  transition 
have  also  looked  to  the  Community  framework  when  developing  proposals  for  major  accident 
controls. 

CONSULTATION  ON  PROPOSED  REVISION 

the  Mines  Safety 

and  Health  Commission 

The organizations  consulted  by the Commission  during the development  of this proposal  include 
the  Advisory  Committee  on  Safety,  Hygiene  and  Health  Protection  at  Work  set  up  by 
Decision  74/325/EEC(9), 
by 
Decision  74/326/EEC(10), the European Council of Chemical Manufacturers' Federations (CEFIC), 
the  Oil  Companies'  European  Organization 
for  Environmental  and  Health  Protection 
(CONCAWE),  the  Oil  Industry  International  Exploration  and  Production  Forum  (E  &  P 
FORUM),  the  European  Liquefied  Petroleum  Gas  Association  (AEGPL),  the  Union  of  the  Gas 
Industries  of the  Common  Market  (MARCOGAZ),  the  European  Federation  of  Chemical  Trade 
(FECC), the European Petroleum Industry Association (EUROPIA), the European Industrial Gases 
Association  (EIGA),  the  International  Group  of  National  Associations  of  Manufacturers  of 
Agrochemical  Products  (GIFAP),  EUROMETAUX,  the  Federation  of  European  Explosives 
Manufacturers (FEEM), the European Fertilizer Manufacturers Association (EFMA), the European 
Crop Protection Association  (ECPA), the European Trade Union Technical Bureau for Health and 
Safety,  and  the  European  Trade  Union  Institute  (ETUI). 

set 

up 

All  Competent  Authorities  of  the  Member  States  have  been  involved  in  detailed  discussions  at 
five meetings of national  experts to discuss the work  and two special working groups to  elaborate 
the  application  Annex  and  the  system  of  accident  reporting. 

(9) 
(10) 

OJNo  L  185, 9.7.1974,  p.  15. 
OJ  No  L  185,  9.7.1974,  p.  18. 

11 

LEGAL  BASIS 

The legal  basis of this proposed  Directive is Article  130s, paragraph  1, of the Treaty  on European 
Union.  Its main objective  is to ensure high  levels of protection  throughout  the Community  in the 
prevention  of major  accidents involving  dangerous substances and thus preserving  and protecting 
the quality of the environment  and protecting human health. The implementation  of the  Directive 
by  Member  States  can  also  have  implications  for  the  conditions  of  competition  inside  the 
Community  but  these  issues  are  of  a  secondary  nature  and  have  also  been  addressed  in  the 
proposal. 

Since the adoption of Council Directive 82/501/EEC and its amendments various Directives under 
Article  118A  have  been  adopted,  notably  Council  Directive  89/391/EEC0 ])  on  the  introduction 
of measures to encourage improvements in the safety  and health  of workers at work. Even though 
the provisions of Council Directive 82/501/EEC were not amended by 89/391/EEC, the provisions 
of these various Directives complement the provisions to manage major accident hazards. Because 
of their  complex nature  Major  Accident  controls  can  only  be  dealt  with  in  an  integrated  fashion 
addressing  both  the  environment  and  man,  inside  and  outside  the  establishment,  so  in  order  to 
show  the  complementary  nature  of  these  proposals  a  cross  reference  to  the  Directives  adopted 
under  Article  118A has  been  made. 

Some  of  the  establishments  covered  by  this  proposal  will  also  be  within  the  scope  of  the 
proposed Directive on integrated pollution prevention  and control(12), and Directive 85/337/EEC(13) 
on  the  assessment  of  the  effects  of  certain  public  and  private  projects  on  the  environment. 
However  in  neither  case  does  this  cause  any  conflict  with  this  proposal  as  they  have  different 
objectives. 

The  proposed  Directive  on  integrated  pollution  prevention  and  control  is  concerned  with 
emissions produced  as part of the normal  operation  of the installation.  This should be  contrasted 
with the present proposal  which  is concerned  with  adventitious  emissions during  an  uncontrolled 
incident.  Directive  85/337/EEC  applies  to  a  very  wide  range  of  projects.  As  far  as  it  would 
cover  establishments  within  the  scope  of  this  proposal,  it  addresses  the  evaluation  of  the  likely 
environmental  impact of a planned establishment  and public participation  in the decision-  making 
process.  Whilst  the  safety  of  the  establishment  may  be  a  relevant  issue,  the  focus  of  that 
Directive  is  on  deciding  whether  it  should  be  built.  The  present  proposal  will  only  come  into 
play  once  that  decision  has  been  taken. 

It  is however  recognized  that,  despite the  differing  objectives  of these  two  instruments,  some of 
the  documents  (or parts  of  documents)  produced  to  comply  with  them  could  also  be  relevant  to 
the  Safety  Report  required  for  this  proposed  Directive.  To  reduce  unnecessary  duplication  of 
effort  in  such  circumstances  the  text  specifically  allows  for  the  use  of  such  documents  for  the 
purposes  of  the  Safety  Report. 

( n) 
(12) 
(,3) 

O J N oL  183, 29.6.1989,  p.  1. 
COM  (93)  423  final. 
OJ  No  L  175,  5.7.1985,  p. 40. 

12 

PRESENTATION  OF  THE  ARTICLES 

Articles  1 and  2 

These  Articles  define  the  application  of  the  Directive,  and  outline  its  objectives. 

Application  will be based  upon  any establishment  where  dangerous  substances  are present  above 
a  certain  threshold  set  out  in  Annex  I.  The  requirements  with  respect  to  smaller  establishments 
are  linked  to  column  2 of  Parts  1 and  2 of  Annex  1. Requirements  for  larger  establishments  are 
linked  to  column  3 of  Parts  1 and  2  of  Annex  1. 

Article  3 

The Article  defines  the basic terms used in the Directive.  Only  the terms used  in  a specific  sense 
in  this  proposal  are  defined. 

Establishment 

This is the whole area under the control  of the operator to which the Directive applies. It includes 
not only  those installations  or storage  areas where dangerous  substances  are present  but  all  other 
activities at that place. This is a crucial  concept  in the system  of  application,  in that it  recognises 
that  all  aspects  of  the  establishment  can  be  affected  by  or  indeed  affect  a Major  Accident.  It  is 
especially  important to consider the establishment  as a whole if the concept of good  management 
practice  is to  be promoted  and  an  integrated  approach  to  the  control  of  major  accidents  is to  be 
maintained. 

Installation  and  Storage 

This  is  the  plant  or  equipment  at  an  establishment  involved  in  the  processing  of  dangerous 
substances  and,  together  with  those  storage  areas  used  for  the  purpose  of  storing  dangerous 
substances,  is the  place  where  a major  accident  is  likely  to  occur.  It  is  therefore  the  area  about 
which  the  operator  is  required  to  provide  specific  details. 

Operator 

This  is  the  individual  who  or  the  organization  which  is  in  charge  of  the  establishment  and  is 
therefore  responsible  for  compliance  with  the  Directive. 

Dangerous  Substance 

A dangerous substance as defined  is any  substance present on site, even those liable to be present 
as a result of  an accident,  and  either  listed in Part  1 of  Annex  1 or fulfilling  the criteria of Part  2 
of  Annex  1. For  the  purposes  of  this  Directive  only,  it  includes  mixtures  and  preparations. 

13 

Major  Accident 

A  major  accident  is the  type  of  event  which  the  proposal  is  designed  to  control.  The  definition 
given  is  identical  to  that  given  in  Council  Directive  82/501/EEC. 

Hazard  and  Risk 

These  terms  are  used  extensively  in  many  areas  of  major  accident  control.  They  are  often  used 
in  ways  which  have  caused  confusion  and  misunderstanding.  By  providing  simple  definitions 
based  upon  those  used  by  the  Institute  of  Chemical  Engineers  harmonized  Community 
requirements  can  be  developed  in  a  consistent  fashion. 

Article  4 

This  Article  outlines  the  exemptions  to  the  proposal.  Military  exemptions  are  maintained  from 
the  current  Council  Directive  82/501/EEC,  whilst  the  hazards  created  by  ionizing  radiation  are 
an  amended  form  of the current  exemption  in recognition  of the fact  that these hazards  are  dealt 
with  by  specific  specialized  legislation.  The  remaining  exemptions  are in  recognition  of the  fact 
that, although  each  of these areas presents major  accident potential, they  do not fall  easily  within 
the  framework  of  this  proposal  given  special  needs  or  special  hazards. 

Article  5 

This  Article  repeats  the  existing  requirements  of  Article  3 of  Council  Directive  82/501/EEC. 

In  the  case  of  establishments  in  mixed  ownership,  the  operators  will  be  required  to  cooperate 
together  to  achieve  compliance  with  the  Directive. 

Article  6 

This  Article  introduces  the  concept  of  a  Major  Accident  Prevention  Policy  (MAPP)  for  all 
establishments  where  dangerous  substances  are present  above  the  first  threshold  quantity,  given 
in  column  2  of  Annex  1 Parts  1 and  2.  The  MAPP  is  a  management  tool  to  ensure  operators 
begin the process of considering major  accidents and introduce appropriate management systems. 
It  is  designed  to  set  out  the  operator's  aims  and  objectives  and  to  ensure  that  these  are 
periodically  reviewed. 

Operators of establishments  covered  by this Article  will  also be required to notify  the  Competent 
Authorities  of  their  existence,  giving  only  basic  details,  such  as  name,  address,  dangerous 
substances  present  etc.  This  is  to  enable  the  Competent  Authority  to  manage  its  programme  of 
inspections  more effectively,  identify  possible domino  effects  and to monitor implementation  by 
operators. 

14 

Article  7 

This  Article  updates  the  requirement  of  Article  4  of  Council  Directive  82/501/EEC  by  relating 
it to the current proposal  and in particular the MAPP. The proposal  does not include  requirements 
formerly  contained  relating  to  worker  training,  and  protective  equipment  since  this  is  now 
extensively  covered by the requirements of Council Directive  89/391/EEC on the introduction  of 
measures to encourage  improvements  in the health  and  safety  of  workers  at work  and its  various 
daughter  Directives. 

Article  8 

This  Article  covers  so  called  Domino  effects.  It  requires  the  Competent  Authority  to  identify 
those  establishments  which  are  so  close  together  that  the  probability  and/or  consequences  of  a 
major  accident  are increased. The Competent  Authorities  shall  act on the basis of the  information 
provided  by  the  operators.  The  provisions  of  Article  9  shall  apply  to  all  the  establishments 
identified,  and the operators  of those establishments will have to exchange information  necessary 
for  compliance  with  the  provisions  of the  Directive.  This  approach  is technically justifiable,  in 
that  it is based  upon  the  information  received  by  the  Competent  Authority  and  the  professional 
judgment  of  that  Authority. 

The  approach  proposed  removes  the  "500  metre  rule"  which  applied  under  the  provisions  of 
Council  Directive  82/501/EEC  and  provides  for  establishments  presenting  the  increased  risk  of 
domino  effects  to  be  dealt  with  effectively  even  if they  are  more than  500m  apart.  Harmonized 
criteria  concerning  the  domino  effect  will  be  established  if  necessary  by  the  Commission. 

Article  9 

This  Article  contains  the  core  requirement  to  prepare  a  safety  report,  previously  contained  in 
Article  5 of Council  Directive  82/501/EEC.  Clear objectives  for  the report  are given  and the link 
between  the  management  systems  used  by  the operator  and  the  report  itself  is  emphasised.  The 
requirement  will  apply  to  all  establishments  where  dangerous  substances  are  present  above  the 
quantities  given  in  column  3 of  Parts  1 or  2  of  Annex  1. 

The  content  of the  safety  report  in technical  terms  remains the  same  as the content  of the  report 
required  under  Council  Directive  82/501/EEC  with  the  important  addition  of  management  and 
organizational  factors,  detailed  in  Annex  2. 

Management  review  is  encouraged  by  the  requirement  to  carry  out  internal  safety  audits  and  to 
review  the  safety  report  periodically,  at  least  every  five  years.  A  flexible  presentation  of  the 
report is allowed to take into account that certain information  is likely to be common to a number 
of  establishments  owned  by  the  same  operator,  or  may  have  been  prepared  in  response  to  other 
legislation.  Harmonized  criteria concerning  safety  reports will be established  if necessary  by the 
Commission. 

15 

Article  10 

This  Article  requires  operators  to update  their  management  systems, particularly  the MAPP  and 
Safety  Report, as a result of  significant  modifications.  It is similar to the requirements  previously 
contained  in  Article  6  of  Council  Directive  82/501/EEC,  amended  to  take  into  account  the 
changes  as  a result  of  this  proposal. 

Article  11 

This Article contains the requirements relating to emergency planning previously  contained within 
Article  5  of  Council  Directive  82/501/EEC  updated  and  separated  from  the  requirement  to 
produce  a  safety  report.  The  Article  contains  clear  objectives  for  the  plans  and,  in  Annex  3, 
details  the  content  of  the  relevant  plans  for  internal  or  external  emergency  response.  The 
responsibility  for  drafting  the internal  plan  rests with the  operator,  whilst the external  plan  is the 
responsibility  of  an  authority  designated  by  the  Member  State.  The  duty  of  the  operator  to 
provide  sufficient  information  to  the  Authorities  to  enable  them  to  produce  the  external 
emergency  plan  is  carried  over  from  the  existing  requirements  of  Directive  82/501/EEC. 

Review,  test  and  implementation  of  the  emergency  plans  are  ensured  by  specific  requirements 
on  the  relevant  party. 

An important new feature  to be incorporated  is the potential  for  the Competent  Authority, on the 
basis of the  information  provided  by the  occupier,  to  assess that  there is no  need  for  an  external 
emergency  plan.  This,  in  practice,  prevents  the  preparation  of  unnecessary  external  emergency 
plans  and  ensures  that  resources  of  the  Member  State  are  thereby  released  for  other  work.  A 
procedure to confirm  decisions taken  under this Article using the Committee procedure  proposed 
under  Article  22  prevents  the  procedure  being  used  inconsistently 
across  the  Community. 
Harmonized  criteria  concerning  this  particular  aspect  can  be  established  if  necessary  by  the 
Commission. 

Article  12 

This  Article  contains  the  provisions  relating  to  siting  and  land  use  planning.  The  approach 
proposed  concentrates upon the essential  elements in the creation of a Community  siting and land 
use  planning  policy,  particularly  the  requirement  for  Member  States  to  produce  individual 
policies, the  exchange  of  information  between  relevant  authorities,  and  the  possibility  to  create 
harmonizd  Community  requirements. 

The proposal  recognizes that major-accident  hazards are only one element to be considered in the 
process  of  land  use  planning  controls.  It  further  recognizes  the  long-term  nature  of  land  use 
planning  policies,  particularly  to  achieve  the  aim  of  separation  of  major  accident  hazards  and 
residential  areas, areas of public occupancy, and natural  areas of particular interest or  sensitivity. 
Guidelines  concerning  land  use  planning  criteria  will  be  established  if  necessary  by  the 
Commission. 

16 

Article  13 

This  Article  retains  the  requirement  to  provide  information  of  a  simple  nature  to  persons  liable 
to  be  affected 
in  the  case  of  a  Major  Accident,  currently  contained  in  Article  8  of 
Directive  82/501/EEC. 

The  policy  of  freedom  of  access  to  information,  begun  in  Council  Directive  90/313/EEC,  is 
however  continued  by  making  the  Safety  Report,  produced  in  response  to  Article  9,  a  public 
document,  and  by  involving  the  public  in  procedures  and  debate  relating  to  siting  and  land  use 
planning  specifically  and major  accident  control  policies  of the  Competent  Authority  in  general. 

The requirement  to provide  information  to neighbouring  States  is carried  over  from  the  existing 
Directive  82/501/EEC and  extended to the  exchange  of  criteria  regarding  decisions  taken by  the 
Competent  Authority. 

The  confidentiality  of  information  is  ensured,  where  necessary,  by  reference  to  the  same 
principles  used  within  Council  Directive  90/313/EEC. 

The  Article  further  requires  the  operator  to  produce  an  inventory  of  the  dangerous  substances 
present  at  the  establishment,  above  the  higher  threshold  quantity,  to  provide  a  copy  to  the 
Competent  Authority,  and  to  make  it  available  to  the  public. 

Articles  14 and  15 

These Articles provide for  the reporting  of major  accidents. Article  14 relates to the reporting by 
the  operator  to  the  Competent  Authority,  and  Article  15  by  the  Competent  Authority  to  the 
Commission. 

Examination  of the major  accidents  reported  to the  Commission  over the  10 years of  experience 
under  the  requirements  of  Council  Directive  82/501/EEC  shows  that  the  deficiencies  of  the 
existing system relate to the lack of harmonized  criteria and long periods before  reports are made. 
Both these deficiencies  are addressed in the present proposal  with the mechanism  for  developing 
criteria  and  a  two  stage  reporting  system,  which  ensures  that  essential  information  is  rapidly 
available. 
In  addition,  provision  is  made  for  the  drawing  up  by  the  Commission  of  a 
questionnaire  for  the  transmission  to  it  of  the  information  required. 

Articles  16.  17 and  18 

These Articles maintain  and build  upon the responsibilities  and  duties of  Competent  Authorities. 
Study  of  the  existing  requirements  of  Council  Directive  82/501/EEC  shows  that  one  of  the 
greatest  harmonizing  factors  in  the  legislation  relating  to  major  accident  control  is the  practical 
implementation, achieved by the Competent Authorities, and their inspection of the establishments 
covered. 

17 

The  details  included  within  the  inspection  requirements  contained  in  the  Article  are  designed  to 
improve  the management  of  the inspection  process  by  the Competent  Authorities  and to  provide 
for sufficient  information  and resources to ensure harmonized implementation  at a practical level. 
The  Commission  will  if  necessary  establish  the  harmonized  criteria  applicable  to the  inspection 
programmes  and  procedures. 

Articles  19  and  20 

These  Articles  relate  to  the  availability  of  information  on  Major  Accidents,  and  particularly  the 
duties  of  the  Commission  to  ensure  access  to  information.  The  most  successful  action  taken  by 
the  Commission  in  the  past  ten  years  in  this  field  has  been  the  creation  and  operation  of  the 
Community  Documentation  Centre  on  Industrial  Risk  (CDCIR)  and  the  creation  and  operation 
of the  Major  Accident  Reporting  System  (MARS).  These  activities  have been  used  as the  basis 
for  the  proposals  contained  within  these  Articles  and  emphasize  the  essential  role  information 
exchange  plays  in  the  control  of  major  accident  hazards. 

The  proposals  forming  the  basis  of  Article  20  are  modelled  closely  upon  the  phrasing  used  in 
Council  Directive  90/313/EEC  on  freedom  of  access  to  information  on  the  environment. 

The  role  the  Commission  plays  to  ensure  harmonized  implementation  of  the  Directive  is 
emphasized  by  the  requirement  to  request  information  from  the  Member  States,  and  to  receive 
an  annual  report  giving  basic  information  on  the  action  taken. 

Articles  21  and  22 

These Articles  contain  provisions  relating to the adaptation  of the Annexes to technical  progress, 
and  the  development  of  harmonized  Community  requirements. 

Articles  23  to  25 

These Articles concern the entry into force of the new Directive and revoke the existing Directive 
82/501/EEC,  as  amended.  The  dates  chosen  for  revocation  and  implementation  are the  same  to 
prevent  any  overlap  and  consequent  confusion  due  to  differences  between  the  regimes. 

Annex  1 

This  Annex  determines  the  application  of  the  relevant  Articles  of  the  Directive  and  covers  all 
relevant  establishments.  There  is no  differentiation  made  between  storage  and  use  of  dangerous 
substances  since  the  application  of  the  Directive  is based  clearly  upon  the  potential  to  create  a 
major  accident,  i.e.  hazard,  which  is  identical  for  the  same  quantity  of  dangerous  substance 
wherever  it  occurs. 

The  differentiation  between  the  likelihood  of  a major  accident  occurring,  i.e.  risk,  is  dealt  with 
in  terms  of  the  specific  measures  taken  by  each  establishment,  and  so  is  best  dealt  with  in  the 
specific  areas  of  concern,  such  as Land  Use  Planning,  or  specific  technical  requirements. 

18 

Part  1 of  the  Annex  contains  a  list  of  named  substances  which  are  in  most  cases  carried  over 
from  Annexes II and III of Directive  82/501/EEC with identical  qualifying  quantities for both the 
requirements  of  Articles  6,  7  and  9.  The  number  of  named  substances  listed  in  Part  1  is 
significantly  reduced  from  the  number  currently  listed  in  Part  1 of  Annex  II  and  Annex  III  of 
Directive  82/501/EEC  since  study  of  the  current  situation  in the  Community  indicates  that 53% 
of  the  substances  listed  in  the  those  Annexes  are  not  used  in  the  establishments  covered  (84 
substances  used out of  180 listed), and those remaining  substances  which  are currently  listed  can 
be  further  reduced  by  their  inclusion  into  the  categories  given  in  Part  2  of  the  proposal.  The 
effect  of this is to produce  a significantly  shorter  list of named  substances  which  are listed  since 
they  have  significantly  different  qualifying  quantities  to  categories  covered  in  Part  2. 

Part  2 of the  Anex  contains  a set of  categories  similar  to  the  format  used  in Part  2 of  Annex  II 
of Directive  82/501/EEC. Each category  is given  a specific  listing and a category  "dangerous  for 
the  environment"  as  well  as  a  category  covering  special  hazards  are  introduced.  A  substance  is 
covered  by  a  category,  where  it  is  not  already  covered  under  Part  1,  when  it  is  classified 
according  to the relevant  Council  Directive, listed  in note  1 of the Annex.  Special  notes  relating 
to  explosives  and  the various  flammable  categories  provide  further  technical  clarification  based 
upon  the  major  accident  hazard  of  the particular  categories  involved.  A  simplified  rule  is  given 
to permit the  addition  of  certain  categories.  This rule,  although  simplified,  allows  for  situations 
where  establishments  have  a large  number  of  different  substances  present,  with  the  potential  to 
create,  in  combination,  a major  accident. 

Annex  2 

This  Annex  contains  the  items  to  be  considered  in  the  safety  report  required  by  Article  9.  The 
content  of  Parts  1, 2, 3, and  4 of the  Annex  correspond  to the  requirements  of  the  safety  report 
contained  within  the  Article  5 of  Council  Directive  82/501/EEC.  Part  5 is  completely  new  and 
requires consideration  of management  systems and organizational  factors.  The inclusion  of these 
matters  into  the  safety  report  underlines  the  fact  that  95%  of  all  major  accidents  have 
management  error  as their  underlying  cause. By  addressing  this  issue  directly  within  the  safety 
report,  the  core  requirement  of  the  Directive,  the  proposal  emphasizes  its  commitment  to 
preventing  and  controlling  major  accidents. 

Annex  3 

This Annex  contains the items to be included  in the  emergency  plans required  under  Article  11. 
The  detail  required  for  internal  and  external  emergency  plans  is  outlined  and  the  link  between 
the  management  of  the  establishment  and  the  emergency  services  emphasized.  Information 
exchange  with  respect  to  accidents  with  possible  transboundary  consequences  is  also  covered 
within  the  context  of  the  external  emergency  plan. 

Annex  4 

This Annex lists the information  to be given to the public in terms of  Article  13.1. It is identical 
to  the  requirements  contained  within  the  current  Council  Directive  82/501/EEC  Annex  VII. 

19 

Proposal  for  a 
COUNCIL  DIRECTIVE 
on  the  control  of  major-accident  hazards  involving  dangerous  substances  (COMAH) 

THE  COUNCIL  OF  THE  EUROPEAN  UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular  Article 
130s(l)  thereof, 

Having  regard  to  the  proposal  from  the  Commission, 

In  cooperation  with  the  European  Parliament, 

Having  regard  to  the  opinion  of  the  Economic  and  Social  Committee, 

Whereas Council Directive  82/501/EEC of 24 June  1982 on the major-accident  hazards of certain 
industrial  activities0},  as  last  amended  by  Directive  91/692/EEC(2),  is  concerned  with  the 
prevention  of major  accidents which  might  result  from  certain  industrial  activities  and  with  the 
limitation  of  their  consequences  for  man  and  the  environment; 

Whereas  the  objectives  and  principles  of  the  Community's  environment  policy,  as  set  out  in 
Article  13 0r( 1 )  and  (2)  of  the  Treaty  and  detailed  in  the  European  Community's  Action 
Programmes on the Environment^, aim, in particular,  at preserving  and protecting the quality  of 
the  environment,  and  protecting  human  health,  through  preventive  action; 

the  Environment^  highlighted 

Whereas  the  Council  in  its  accompanying  resolution  concerning  the  Fourth  Action  Programme 
implementation  of 
on 
Directive  82/501/EEC,  and  called  for  the  review  of  the  Directive,  if  necessary,  to  include 
inter  alia  a possible  widening  of  its scope, and  a greater  exchange  of  information  on  the  matter 
between  Member  States; 

for  more  effective 

the  need 

Whereas the  Council  Resolution  of  16 October  1989(5) invited  the Commission  to  consider  ways 
of including in the Directive planning controls on land use, taking into account, in particular, the 
consequences  of  the  accident  at  Bhopal,  and  the  means  of  seeking  mutual  understanding  and 
harmonization  of  national  principles  and  practices  regarding  safety  reports; 

(i) 

(2) 

(3) 

(4) 

(5) 

O J N o L 2 3 0,  5.8.1982,  p.  1. 
O J N oL  377, 31.12.1991, p. 48. 
OJNo  C  112, 20.12.1973, p. 1 
O J N oC  139,  13.6.1977, p. 1 
O J N o C 4 6,  17.2.1983, p. 1 
OJNo  C 70,  18.3.1987, p.  1. 
O J N oC  138,  17.5.1993, p.l 
O J N oC  328,  7.12.1987,  p. 3. 
O J N oC  273, 26.10.1989, p.  1. 

20 

Whereas Directive  82/501/EEC constitutes a first  stage in the harmonization  process; whereas the 
measures  taken  by  the  Member  States  to  implement  that  Directive  have  resulted  in  differing 
levels  of  protection  of  man  and  the  environment; 

Whereas major  accidents can have repercussions beyond frontiers;  whereas the environmental  and 
economic  cost  of  an  accident  is  borne  not  only  by  the  establishment  affected  but  also  by  the 
competent  authorities  of  the Member  States concerned;  whereas  it is therefore  necessary  to take 
measures  ensuring  a high  level  of  protection  throughout  the  Community; 

Whereas  action  at Community  level  is necessary  in order  to modify  and to supplement  Directive 
82/501/EEC;  whereas  the  present  harmonization  is  limited  to  the  measures  which  are  necessary 
to put in place a more effective  system  for preventing  major  accidents having widespread  effects 
and  for  limiting  their  consequences  by  improving  safety  management,  land-use  policies,  the 
provision  of  information  to the public  and  inspection  systems  in  order  to  ensure  a high  level  of 
protection  for  man  and  the  environment  throughout  the  Community. 

Whereas  in  order  to  take  account  of  the  significant  changes  that  have  occurred  in  industrial 
practice regarding risk management and the prevention  of major  accidents, Directive  82/501/EEC 
should be replaced by more extensive provisions seeking to ensure that those in control of  major-
hazard  plants  throughout  the  Community  provide  a high  level  of  safety; 

Whereas  the  use  of  a  list  specifying  certain  undertakings  and  excluding  others  with  identical 
hazards  is inflexible  and  technically  unsound,  and  allow  potential  sources  of  major  accidents  to 
escape  regulation;  whereas  the  scope  of  the  Directive  should  be  altered  in  order  to  make  the 
provisions applicable to all establishments where dangerous substances are present in  sufficiently 
large  quantitites to  create  a major-accident  hazard; 

Whereas  analysis  of  the  major  accidents  reported  in  the  Community  indicates  that  the  majority 
of  them  are the  result  of  managerial  and/or  organizational  shortcomings;  whereas  it  is  therefore 
necessary to lay down at Community level  essential requirements for management systems, which 
must  be  suitable  for  controlling  major-accident  hazards; 

Whereas  differences  in  the  arrangements  for  the  inspection  of  establishments  by  the  competent 
authorities  may  give rise to differing  levels  of protection;  whereas  it is necessary  to  lay  down  at 
Community  level  the  essential  requirements  with  which  the  control  systems  established  by  the 
Member  States  must  comply; 

Whereas in order to prevent  major  accidents, the operator  must, for  every  establishment  at which 
dangerous  substances  are  present  and  where,  in  the  event  of  a  major  accident,  there  may  be 
serious  consequences  for  man  and  the  environment,  take  all  measures necessary  to prevent  such 
accidents  and  to  limit  the  consequences  thereof; 

Whereas,  in  order  to  improve  management  systems  and  reduce  human  error,  in  the  case  of 
establishments where dangerous substances are present in certain  quantities it is necessary  for  the 
operator to introduce a major-accident  prevention policy and systems to improve the management 
of safety  in the establishment  and  to provide the competent  authority  with information  sufficient 
to  enable  it  to  identify  the  establishment,  the  dangerous  substances  present  and  the  potential 
dangers,  in  order  that  it  may  manage  its  resources  and  responsibilities  adequately; 

21 

Whereas,  in  order  to  demonstrate  the  preventive  measures,  contingency  plans  and  response 
measures  taken,  the  operator  should,  in  the  case  of  establishments  where  dangerous  substances 
are present in significant  quantities, provide the competent authority  with information  in the  form 
of  a  safety  report  containing  details  of  the  establishment,  the  dangerous  substances  present,  the 
installation  or storage facilities,  possible  major  accidents  and the management  systems  available, 
in  order  to  reduce  the  risk  of  major  accidents  and  to  enable  the  necessary  steps  to  be  taken  to 
reduce  the  consequences  thereof; 

Whereas  in  order  to  reduce  the  risk  of  domino  effects,  the  operators  should,  in  the  case  of 
establishments  which  are  so  close  together  that  the  probability  of  a  major  accident  may  be 
increased, or its consequences  aggravated, cooperate in  devising measures to prevent, prepare  for 
and  respond  to  major  accidents; 

Whereas, in order to provide against emergencies, in the case of establishments where  dangerous 
substances  are  present  in  significant  quantities  it  is  necessary  to  establish  external  and  internal 
emergency  plans  in  response  to  major  accidents  and  to  create  systems  to  ensure  those  plans  are 
tested  and  revised  as  necessary  and  implemented  in  the  event  of  a  major  accident  or  threat 
thereof; 

Whereas,  where  an  external  emergency  plan  is  not  prepared  within  the  period  fixed,  it  is 
necessary  to  make  authorities  responsible  for  the  creation  of  the  external  emergency  plan  liable 
for  any  costs  incurred  by  the  operator  owing  to  his  being  unable  to  operate  his  establishment; 

Whereas,  in  order  to promote  access  to  information  on  the  environment  the  public  should  have 
access to the safety  report produced by the operator,  and persons  liable to be affected  by  a  major 
accident  should  be given  information  sufficient  to  inform  them  of the  correct  action  to be taken 
in  the  event  of  a major  accident; 

Whereas,  in  order  to  provide  greater  protection  from  major-accident  hazards  for  centres  of 
population  and natural  areas of particular interest or sensitivity, it is necessary  for Member States' 
land-use  policies  to  take  account  of  the  need  for  adequate  separation  between  such  areas  and 
establishments  presenting  such  hazards.  Such  policies  should  include  consultation  procedures 
between  competent  authorities  and  planning  authorities; 

Whereas, in order to ensure that adequate response measures are taken if a major  accident occurs, 
the operator must immediately inform the competent authorities and communicate the  information 
necessary  for  assessing  the  impact  of  that  accident; 

Whereas,  in  order  to  provide  for  an  information  exchange  and  to  prevent  future  accidents  of  a 
similar  nature,  Member  States  should  forward  information  to  the  Commission  regarding  major 
accidents occurring in their territory, so that the Commission  can analyse the hazards from  major 
accidents, and operate an information  system for the distribution  of information  on any particular 
major  accident,  and  the  lessons  learned  from  it; 

Whereas in the establishment of management systems in the field of preventing, preparing  against 
and  responding  to  major  accidents  involving  dangerous  substances  it  is  necessary  to  ensure 
appropriate participation  by workers in the establishment, in order to contribute to the prevention 
of  occupational  risks  and  to  promote  protection  of  the  health  and  safety  of  workers; 

22 

Whereas  the  requirements  of  this  Directive  should  not  prejudice  Community  requirements 
concerning  the  working  environment  as  regards  the  health  and  safety  of  workers, 

HAS  ADOPTED  THIS  DIRECTIVE: 

Article  1 

the  prevention  of  major  accidents  which  involve  dangerous 
This  Directive  is  aimed  at 
substances,  and  the  limitation  of  their  consequences  for  man  and  the  environment,  with  a  view 
to  ensuring  high  levels  of  protection  throughout  the  Community. 

Article  2 

1. 

2. 

The  Directive  will  apply  to  any  establishment  where  dangerous  substances  are  present, 
or  likely  to  be produced  as  a result  of  an  accident,  in  quantities  equal  to  or  in  excess of 
the quantities  listed  in Annex  1, Parts  1 and  2, column  2, with the  exception  of Article  9, 
which  will  apply  to  any  establishment  where  dangerous  substances  are present,  or  likely 
to  be  produced  as  a  result  of  an  accident,  in  quantities  equal  to  or  in  excess  of  the 
quantities  listed  in  Annex  1, Parts  1 and  2,  column  3. 

The  requirements  of  this  Directive  shall  apply  without  prejudice  to  Community 
requirements  concerning  the  working  environment,  and,  in  particular,  without  prejudice 
to  Council  Directive  89/391/EEC(6). 

For  the  purposes  of  this  Directive: 

Article  3 

(a) 

(b) 

(c) 

(d) 

'Establishment'  means  the  whole  area  under  the  control  of  an  operator  where  dangerous 
substances are present in any installation or any storage facility  and all the remaining  area 
under the control of the operator at that place, including administrative buildings, ancillary 
equipment,  pipework,  storage,  process  and  production  equipment,  marshalling  yards, 
docks, piers, jetties,  depots,  or  similar  structures,  whether  floating  or  not. 

'Installation'  means  the  equipment,  building,  pipework,  machinery,  tools  and  all  other 
appliances,  whether  fixed  or  not,  at  an  establishment  for  the  chemical,  physical  or 
biological  processing  of  a  dangerous  substance. 

'Operator'  means  any person  (including  individuals  and corporate bodies), responsible  for 
the  control  of  an  establishment  covered  by  this  Directive. 

'Dangerous substance' means a substance, mixture or preparation  listed in Annex  1, Part  1, 
or  fulfilling  the  criteria  laid  down  in  Annex  1,  Part  2,  and  present  as  a  raw  material, 
product,  by-product,  residue, or intermediary,  including those substances produced  in the 
course  of  an  accident. 

(6) 

O J N oL  183, 29.6.1989,  p.  1. 

23 

(e) 

(f) 

(g) 

(h) 

'Major  accident'  means  an  occurrence  such  as  a  major  emission,  fire,  or  explosion 
resulting  from  uncontrolled  developments  in  the  course  of  the  operation  of  any 
establishment  covered  by  this  Directive,  and  leading  to  serious  danger  to man  and/or  the 
environment, immediate or delayed, inside or outside the establishment, and involving one 
or  more  dangerous  substances. 

'Hazard'  means the intrinsic property  of  a dangerous  substance  or physical  situation  at an 
establishment,  with  a potential  for  creating  damage. 

'Risk'  means  the  likelihood  of  a  specific  effect  occurring  within  a  specified  period  or  in 
specified  circumstances. 

'Storage'  means  the  presence  of  a  quantity  of  dangerous  substances  for  the  purposes  of 
warehousing,  depositing  in  safe  custody  or  keeping  in  stock  for  trading  purposes. 

Article  4 

This  Directive  shall  not  apply  to  the  following: 

(a) 

military  installations  or  storage  facilities; 

(b) 

hazards  created  by  ionizing  radiation; 

(c) 

(d) 

(e) 

1. 

2. 

the  transport  of  dangerous  substances  by  road,  rail,  water,  or  air,  outside  the 
establishments  covered  by  this  Directive; 

the  transmission  of  dangerous  substances  in  pipelines  outside  the  establishment  covered 
by  this  Directive; 

The  activities  of  the  extractive  industries  concerned  with  exploration  for,  and  the 
exploitation  of,  minerals  in  mines  and  quarries  or  by  means  of  boreholes,  including  the 
preparation  of  extracted  materials  for  sale. 

Article  5 

Member  States  shall  ensure that the operator  is obliged  to take  all  measures  necessary  to 
prevent  major  accidents  and  to  limit  their  consequences  for  man  and  the  environment. 

In the  case of  establishments  where  there  is more than  one operator,  owing  to the  mixed 
ownership  or control  of the  establishment  concerned,  Member  States  shall  ensure that  all 
the  operators  are  collectively  responsible  for  compliance  with  this  Directive  and  in 
particular  the  production  of  the  safety  report  required  by  Article  9(1). 

24 

Article  6 

1. 

Without  prejudice  to  Article  5,  Member  States  shall  require  operators  to  draw  up  a 
document  setting  out  their  Major  Accident  Prevention  Policy  and  in  particular  a 
management  system  and  procedures.  That  document  shall  cover  the  following  elements: 

(a) 

(b) 

the  overall  aims, approach  and  specific  objectives  of  the  operator  in  the  control  of 
major  accidents; 

the  principles  and  criteria  on  which  action  to  prevent,  and  respond  to  major 
accidents  is  based; 

(c) 

the  identification  of  major-accident  hazards; 

(d) 

the  measures  identified  as necessary  to  prevent  major  accidents; 

(e) 

(f) 

(g) 

(h) 

the  measures  identified  as necessary  to  limit  the  consequences  of  major  accidents 
for  man  and  the  environment; 

the  organization  and  procedures  necessary  for  implementing  and  managing  the 
Major-Accident  Prevention  Policy  including  the  appointment  of  suitably  qualified 
and  trained  personnel; 

the programme for  implementation,  assessment of effectiveness  and introduction  of 
improvements; 

the  periodic  review  of  the  Major-Accident  Prevention  Policy  and  management 
system  by  senior  management  of the  establishment,  in order  to  check  performance 
against  relevant  standards. 

2. 

Member  States  shall  require  the  operator  to  send  the  competent  authority  specified  in 
Article  16 a notification  in  writing  within  the  following  time-limits: 

for  new  establishments,  between  four  and  eight  months  before  commencing 
construction  or  operation; 

for  existing  establishments,  a  period  of  time  between  eight  and  twelve  months 
after  the  date  referred  to  in  Article  24(1); 

3. 

The  notification  required  by  paragraph  2  shall  contain  the  following  details: 

(a) 

the name  or trade name of  the  operator  and  complete  address of  the  establishment 
concerned; 

(b) 

the  registered  place  of  business  of  the  operator  and  complete  address; 

25 

(c) 

(d) 

the  name  of  a  director  or  person  in  charge  of  the  establishment,  if  different 
from  (a); 

information  sufficient  to identify  the dangerous substance or category  of substances 
involved; 

(e) 

the  quantity  and physical  form  of  the  dangerous  substance  or  substances  involved; 

(f) 

the  activity  or  proposed  activity  of  the  installation  or  storage. 

4. 

5. 

In the case of  existing  establishments  for  which  the operator  has  already  provided  all  the 
information  under  paragraph  3  to  the  competent  authority  under  the  requirements  of 
national  law  at  the  date  of  entry  into  force  of  this  Directive,  notification  under 
paragraph  2 is not  required. 

In  the  event  of  any  significant  change  to the  maximum  quantity  or  physical  form  of  the 
dangerous  substance  present,  as  indicated  in  the  notification  provided  by  the  operator 
pursuant  to  paragraph  2, or  in  the  event  of  the permanent  closure  of the  installation,  the 
operator  shall  immediately  inform  the  competent  authority  of  the  change. 

Article  7 

Member  States  shall  ensure that  all operators are required to prove to the  competent  authority  at 
any  time, in particular  for  the purposes  of the  inspections  and  controls  referred  to  in  Article  18, 
that  they  have  taken  all  the  measures  necessary  as  specified  in  this  Directive. 

Article  8 

1. 

Member  States  shall  ensure  that  the  competent  authority  using  the  information  received 
from  operators  in  compliance  with  this  Directive  and  taking  into  account  inter  alia  the 
location, proximity  and total quantities of dangerous substances present, identifies  groups 
of  establishments  where  the  likelihood  of  a major  accident  may  be  increased. 

For  the  purposes  of  this  Article  the  competent  authority  shall  identify  those  groups  of 
establishments  where  the  total  quantity  of  dangerous  substances  is  equal  to  or  in  excess 
of  the  relevant  quantity  listed  in  Annex  1, Parts  1 and  2,  column  3. 

2. 

Member  States  shall  ensure  that,  whenever  an  increased  likelihood  or  an  aggravation  of 
major  accidents  is  identified  under  paragraph  1 in  a group  of  establishments: 

(a) 

the  provisions  of  Article  9  are  extended  to  all  the  establishments  thus  identified; 

(b) 

the  operators  of  all  the  establishments  identified  shall  exchange  such  information 
to  take  account  of  the  overall  major-accident 
as  is  necessary  to  enable  them  all 
hazard; 

in  their  Major-Accident  Prevention  Policy, 

in  their  management  systems, 

26 

in  their  management  systems, 

in  the  safety  report, 

(c) 

the  operators  of  all  the  establishments  identified  are  required  to  cooperate  in  the 
preparation  of  emergency  plans  and  the  provision  of  information  to  the  public. 

3. 

Member  States  shall  inform  the  Commission  of  the  criteria  which  they  apply  in 
determining  the  conditions  under  which  the  provisions  of  Article  9  are  to  be  applied  to 
all  the  establishments  of  a  group.  The  Commission  shall,  if  necessary,  establish 
harmonized  criteria,  in  accordance  with  the  procedure  laid  down  in  Article  22. 

1. 

Without  prejudice  to  Articles  5,  6  and  7,  Member  States  shall  require  the  operator  to 
produce  a  safety  report  for  the  purposes  of: 

Article  9 

(a) 

(b) 

(c) 

(d) 

demonstrating  the  establishment  and  implementation  of  the  Major-Accident 
in 
Prevention  Policy  and  mnagement  systems  and  procedures,  as  specified 
Article  6(1); 

demonstrating  the  safety  and  reliability  incorporated  into  the  design,  construction, 
and  covering,  where  appropriate,  the  abandonment  of  the  installation,  storage  or 
establishment; 

demonstrating  the  safe  operation  and  maintenance  of  the  installation  or  storage 
facility; 

detailing  the  operational  requirements  and  limitations  of  the  establishment  with 
respect  to  technical,  organizational  and  managerial  matters  used  to  prevent  major 
accidents; 

(e) 

providing  for  continuing  safety  assurance  by  means  of  regular  review; 

(f) 

(g) 

providing  for  emergency  preparedness  and for  the response in the event of  a  major 
accident; 

providing sufficient  information  to the relevant authorities to enable decisions to be 
made  in terms of the  siting  and  land  use for  new  establishments  and  developments 
around  existing  establishments. 

27 

The  safety  report,  as  an  integral  part  of  the  safety  management  systems  of  the 
establishment,  shall  contain  the  data  and  information  listed  in  Annex  2. 

Internal  safety  audits  shall  be  carried  out  as an  integral  part  of the  management  system 
of  the  establishment.  The  results  of  these  shall  be  made  available  to  the  competent 
authorities  at  the  time  at  which  inspections  are  carried  out  under  Article  18. 

The  report  presented  to  the  competent  authority  shall  provide  a  clear  description  of  the 
installation  or  storage  concerned,  and  meet  the  objectives  outlined  in  this Article.  Safety 
reports, or  parts of  reports, or  any  other  equivalent  reports produced  in  response  to  other 
legislation,  may  be  combined  to  form  a  single  safety  report  for  the  purposes  of  this 
Article, where such  a format  obviates  the unnecessary  duplication  of information  and the 
repetition  of  work  by  the  operator  or  competent  authority,  on  condition  that  all  the 
requirements  of  this  Article  are  complied  with. 

The  safety  report  or  details  of  the  content,  conclusions  and  any  changes  resulting  from 
the  review  specified  in  paragraph  5,  shall  be  sent  to  the  competent  authority  within  the 
following  time-limits: 

2. 

3. 

for  new  establishments,  between  four  and  eight  months  before  commencing 
construction  or  operation; 

for  existing establishments, within two years of the date referred  to in Article 24(1); 

without  delay  following  periodic  review  under  paragraph  5. 

4. 

Before  the  operator  commences  construction  or  operation,  or,  in  the  cases  referred  to  in 
the  second  and  third  indents  of  paragraph  3,  within  one  year  of  the  submission  of  the 
safety  report,  the  competent  authority  shall: 

write  to  the  operator  expressing  satisfaction  with  the  report;  or 

ask  for  further  information,  to  be  supplied  within  three  months;  or 

prohibit the bringing into use, or the continued use, of the establishment  concerned, 
in  accordance  with  the  powers  and  procedures  laid  down  in  Article  17. 

Where  the  competent  authority  requests  further  information,  the  conclusions  of  its 
examination  of  the  report  must  be  communicated  to  the  operator  within  six  months  of 
submission  of  the  information  required. 

28 

5. 

The safety  report shall be reviewed  and where necessary  updated periodically, as follows: 

at  least  every  five  years; 

at  any  time,  at the  explicit  request  of  the  competent  authority; 

at  any  other  time  to  take  account  as  necessary  of  new  technical  knowledge  about 
safety  matters  and  of  developments  in  knowledge  concerning  the  assessment  of 
hazards. 

6. 

7. 

Where  it  is  demonstrated  to  the  satisfaction  of  the  competent  authority  that  particular 
substances present at the establishment,  or on any  part thereof,  are in a state incapable  of 
creating  a  major-accident  hazard,  then  the  Member  State  may  limit  the  information 
required  in  safety  reports  to  those  matters  which  are  relevant  to  the  prevention  of  those 
residual  major-accident  hazards  and the  limitation  of their  consequences  for  man  and the 
environment. 

Member  States  shall  ensure that  the  competent  authority  publishes  the  criteria  it  intends 
to  use in  reaching  a decision  that  a substance or  establishment  are in  a state incapable  of 
creating  a major-accident  hazard  under  paragraph  6  and  that  it  communicates  a  copy  of 
the  said  criteria  to  the  Commission.  The  Commission  shall,  if  necessary,  establish 
harmonized  criteria  in  accordance  with  the  procedure  laid  down  in  Article  22. 

8. 

Member  States  shall  inform  the  Commission  of  the  criteria  they  use  for: 

risk  analysis  and  risk  evaluation  methods  and  procedures; 

safety  management  systems,  including  safety  audit  methods  and  procedures; 

assessing  the  reliability  of  technical  systems  and  arrangements  for  accident 
prevention. 

The  Commission  shall  if necessary,  establish  harmonized  criteria  in  accordance  with  the 
procedure  laid  down  in  Article  22. 

Article  10 

In  the event  of  the  modification  of  an  installation,  storage  facility  or  establishment  which  could 
have significant  repercussions on major-accident hazards, the Member States shall ensure that the 
operator. 

-  reviews  and where necessary  revises the Major-Accident  Prevention  Policy,  and  management 

systems  and  procedures  referred  to  in  Article  6(1); 

-  reviews,  and  where  necessary  revises,  the  safety  report  and  informs  the  competent  authority 

of  the  details  of  such  revision  in  advance  of  such  modification. 

29 

Article  11 

Member  States  shall  ensure  that,  for  all  establishments  to  which  Article  9  applies: 

(a) 

an  Internal  Emergency  Plan  is  drawn  up  by  the  operator  for  action  inside  the 
establishment,  as  follows: 

for  new  establishments,  prior  to  commencing  operation; 

for  existing  establishments not previously  covered  by Directive  82/501/EEC, 
one  year  from  the  date  referred  to  in  Article  24(1); 

for  other  establishments,  by  the  date  referred  to  in  Article  24(1). 

(b) 

the  necessary  information  is supplied  by  the  operator  to  the  authorities  designated 
by  the  Member  State  for  establishing  External  Emergency  Plans,  so  as  to  enable 
External  Emergency  Plans  to  be  produced,  as  follows: 

for  new  establishments,  between  four  and  eight  months  before  commencing 
construction  or  operation; 

for  existing establishments not previously  covered  by Directive  82/501/EEC, 
two  years  from  the  date  referred  to  in  Article  24(1); 

for  other  establishments,  by  the  date  referred  to  in  Article  24(1). 

(c)  an  External  Emergency  Plan  is  drawn  up  by  the  authorities  designated  for  that 
purpose  by  the  Member  State  for  implementation  outside  the  establishment,  as 
follows: 

for  new  establishments,  prior  to  commencing  operation; 

for  existing establishments  not previously  covered by Directive  82/501/EEC, 
not  more  than  six  months  from  receipt  of the  information  deemed  necessary 
by  the  competent  authority  under  this  Article; 

for  other  establishments,  by  the  date  referred  to  in  Article  24(1). 

The Emergency  Plans  must  be  established  with  the  objectives  of: 

-  containing and controlling incidents so as to minimize the effects,  and to limit damage 

to  man  and  the  environment; 

- 

implementing  response measures to protect man and the environment from  the  effects 
of  major  accidents; 

-  communicating  relevant  information  to  the  public  and  other  services  or  authorities 

concerned  in  the  area; 

30 

-  providing  for  the  restoration  and  clean-up  of  the  environment  following  a  major 

accident. 

Emergency  Plans  shall  contain  the  information  set  out  in  Annex  3. 

3. 

4. 

Member  States  shall  ensure  that,  without  prejudice  to  the  obligations  of  the  competent 
authorities,  the opportunity  of contributing to the preparation  of Emergency Plans under 
this  Directive  is  afforded: 

- 

in  the  case  of  Internal  and  External  Emergency  Plans,  to  personnel  inside  the 
establishment;  and, 

- 

in  the  case  of  External  Emergency  Plans, to  the  public  liable  to  be  affected. 

Member  States  shall  ensure  that  Internal  and  External  Emergency  Plans  are  reviewed, 
tested,  and  where  necessary  revised  and  updated  by  the  operators  and  designated 
authorities  at  suitable  intervals  no  longer  than  three  years.  The  review  shall  take  into 
account  changes  occurring  in  the  establishments  concerned  or  within  the  emergency 
services  concerned,  new  technical  knowledge,  and  knowledge  concerning  the  response 
to  major  accidents. 

5. 

Member  States  shall  ensure  that  Emergency  Plans  are put  into  effect  without  delay  by 
the  person  nominated  or  by  the  designated  authority,  whenever: 

-  a  major  accident  occurs;  or 

-  an uncontrolled event occurs which by its nature could reasonably  be expected to lead 

to  a  major  accident. 

6. 

7. 

Where a safety  report demonstrates to the satisfaction  of the competent  authority that the 
establishment  is incapable  of  creating  a major-accident  hazard beyond  its boundary,  the 
requirements  to  produce  an  External  Emergency  Plan  in  terms  of  Article  11(1)  shall 
not  apply. 

Member  States  shall  ensure  that  the  competent  authority  publishes  the  criteria  which  it 
intends  to  use  in  reaching  a  decision  that  an  establishment  is  incapable  of  creating  a 
major-accident  hazard  beyond  its  boundary  under  of  paragraph  6  and  that  it 
communicates  a copy  of the  said  criteria  to  the  Commission.  The  Commission  shall,  if 
necessary,  establish  harmonized  criteria,  in  accordance  with  the procedure  laid  down  in 
Article  22. 

31 

Article  12 

1. 

Member  States  shall  ensure that their  land-use  policy  includes  among  its objectives  the 
prevention  of  major  accidents  and  the  limitation  of  their  consequences.  They  shall 
accomplish  this  objective  through  controls  on: 

(a) 

the  siting  of  new  establishments; 

(b)  modifications  to  existing  establishments  covered  by  Article  10; 

(c)  new  developments  surrounding  such  existing  establishments  where  the  siting  or 
developments  may  be  liable  to  increase  the  risk  or  consequences  of  a  major 
accident. 

Member  States  shall  ensure  that  their  land-use  policy,  and  the  procedures  for 
implementing  it,  take  account  of  the  need,  in  the  long  term,  to  separate  establishments 
covered by this Directive from  residential  areas, areas of substantial public use, and areas 
of particular  natural  sensitivity  or  interest,  and  also  of  the need  to  facilitate  emergency 
planning  in  the  event  of  a major  accident. 

Member  States  shall  ensure  that  all  competent  authorities  and  planning  authorities 
responsible  for  decisions  on  siting  and  land  use  set  up  appropriate  consultation 
procedures  to facilitate  the implementation  of the policy  established  under  paragraph  1. 
The  procedures  shall  be  designed  to  ensure  that  technical  advice  on  the  risks  arising 
from  the establishment  is available, either  on  a case-by-case  or on  a generic basis, when 
decisions  are  taken. 

Member  States shall  inform  the Commission  of  the siting and land-use planning  criteria 
which  they  apply  for  the  purpose  of  paragraph  1. The  Commission  shall,  if  necessary, 
establish  guidelines  on  such  criteria  in  accordance  with  the  procedure  laid  down  in 
Article  22. 

Article  13 

Member  States  shall  ensure  that  information  on  safety  measures  and  on  the  requisite 
behaviour  in the  event  of  an  accident  is  supplied,  without  their  having  to  request  it, to 
persons liable to be affected  by a major  accident originating  in an establishment  covered 
by  Article  9.  The  information  shall  be  reviewed  every  two  years,  and  where  necessary 
repeated  and  updated,  at  least  if  there  is  any  modification  within  the  meaning  of 
Article  10.  It  shall  also  be  made  permanently  available  to  the  public.  The  maximum 
period  between  the  repetition  of  the  information  to  the  public  shall,  in  any  case,  be  no 
longer  than  four  years. 

Such  information  shall  contain,  at  least,  the  information  listed  in  Annex  4. 

The  Member  States  concerned  shall,  at  the  same  time,  make  available  to  the  other 
Member  States  liable  to  be  affected  in  the  event  of  a  major  accident  originating  in  an 
establishment  under  Article  9  sufficient  information  to  enable  emergency  plans  to  be 
prepared where necessary, and the same information  as is disseminated  at national level. 

32 

2. 

3. 

1. 

2. 

Such  information  shall  be  reviewed,  repeated  and  updated  at  the  same  intervals  as  are 
laid  down  under  paragraph  1. 

3. 

4. 

Where the Member  State  concerned  has decided  that  an  establishment  close to  a border 
with  another  Member  State  is incapable  of  creating  a major-accident  hazard  beyond  its 
boundary  for  the  purposes  of  Article  11(6)  and  is not  therefore  required  to  produce  an 
External Emergency  Plan  under Article  11(1), it shall  so inform  the other Member  State. 

Member  States  shall  ensure  that  the  safety  report  is  made  available  to  the  public.  The 
operator  may  ask  the  competent  authority  not  to  disclose  to  the  public  certain  parts  of 
the  report,  for  reasons  of  industrial,  commercial  or  personal  confidentiality,  public 
security  or national  defence.  In  such  cases, on  the  approval  of  the  competent  authority, 
the operator  shall  supply to the authority,  and make  available to the public, an  amended 
report  excluding  those  matters. 

5. 

Member  States  shall  ensure  that  the public  is  able  to  participate  in  relevant  procedures 
and  debates,  relating  to: 

planning  for  new  establishments  covered  by  Article  9,  modifications  to  existing 
establishments under Article  10, where such modifications  are subject to obligations 
provided  for  in  this  Directive  as  to  planning,  and  developments  around  such 
existing  establishments; 

the  major-accident  hazard  control  policies  and  criteria  of  the  competent  authority 
and  development  policies  and procedures  regarding  siting  and  land-use,  developed 
to  implement  this  Directive. 

6. 

In the  case of  establishments  subject  to the provisions of  Article 9, Member  States shall 
ensure  that  the  operator  provides  the  competent  authority  with  an  inventory  of  all 
dangerous  substances  present  which  attain  or  exceed  the  quantity  listed  in  Annex  1, 
Parts  1  and  2,  column  3,  at  the  establishment;  the  operator  shall  give  the  following 
details: 

information  sufficient  to identify  either  the  dangerous  substance  or the category  of 
dangerous  substance; 

an  indication  of  the  total  quantity  present;  and 

the  source  of  any  additional  information. 

This  inventory  shall  be  updated  annually  and  shall  be  made  available  to  the  public,  on 
the  premises  of  the  establishment. 

33 

Article  14 

1. 

Member  States  shall  take  the  necessary  measures  to  ensure  that,  as  soon  as  practicable 
following  a  major  accident,  the  operator  shall  be  required,  using  the  most  appropriate 
means: 

(a) 

to  inform  the  competent  authorities; 

(b) 

to  provide  them  with  the  following  information  as  soon  as  it  becomes  available: 

the  circumstances  of  the  accident; 

the  dangerous  substances  involved; 

the  data  available  for  assessing  the  effects  of  the  accident  on  man  and  the 
environment;  and 

the  emergency  measures  taken; 

(c) 

to  inform  them  of  the  steps  envisaged: 

to  alleviate  the  medium  and  long-term  effects  of  the  accident; 

to  prevent  any  recurrence  of  such  an  accident; 

(d) 

to  update  the  information  provided  if  further  investigation  reveals  additional  facts 
which  alter  that  information  or  the  conclusions  drawn. 

2. 

The  Member  States  shall  require  the  competent  authorities: 

(a) 

to  ensure  that  any  urgent,  medium  and  long-term  measures  which  may  prove 
necessary  are  taken; 

(b) 

to  collect,  by  inspection,  investigation  or  other  appropriate  means, the  information 
necessary  for  a full  analysis of the technical, organizational  and managerial  aspects 
of  the  major  accident; 

(c) 

to  take  appropriate  action  to  ensure  that the  operator  takes  any  necessary  remedial 
measures;  and 

(d) 

to  make  recommendations  on  future  preventive  measures. 

3. 

Member  States  shall  inform  the Commission  of  the  criteria  they  apply  for  the  reporting 
of  major  accidents  under  Articles  14  and  15.  The  Commission  shall,  if  necessary, 
establish  guidelines concerning such criteria in accordance with the procedure laid down 
in  Article  22. 

34 

Article  15 

1. 

For  the  purposes  of  prevention  and  mitigation  of  major  accidents,  Member  States  shall 
inform  the  Commission  as soon  as practicable  of  major  accidents  which  have  occurred 
within  their  territory  and  shall  provide  it  with  the  following  details: 

(a) 

the Member  State, the name and address of the authority  responsible  for  the  report; 

(b) 

the  date,  time  and  place  of  the  major  accident,  including  the  full  name  of  the 
operator  and  address  of  the  establishment  involved; 

(c)  a  brief  description  of  the  circumstances  of  the  accident,  including  the  dangerous 
substances  involved,  and  the  immediate  effects  on  man  and  the  environment; 

(d)  a  brief  description  of  the  emergency  measures  taken  and  of  the  immediate 

precautions  necessary  to  prevent  recurrence. 

Member  States  shall,  as  soon  as  the  information  is  collected  in  accordance  with 
Article  14, inform  the  Commission  of the  result  of  their  analysis  and  recommendations 
using a report-form  established  and kept under  review through  the procedure  referred  to 
in  Article  22. 

Reporting  of  this  information  by  Member  States  may  be  delayed  only  to  allow  for  the 
those 
completion  of  legal  proceedings  where  such  reporting  is  liable  to  affect 
proceedings. 

the  Commission  of  the  name  and  address  of  any 
Member  States  shall  inform 
organization which might have relevant information  on major accidents and which is able 
to  advise  the  competent  authorities  of  other  Member  States  which  have  to  intervene  in 
the  event  of  such  an  accident. 

Article  16 

2. 

3. 

Member  States  shall  set  up  or  appoint  the  competent  authority  or  authorities  responsible  for 
planning, organizing, authorizing  and supervising  the activities of  establishments  covered by this 
Directive. 

Article  17 

1. 

Member  States  shall  prohibit  the  use  or  bringing  into  use  of  any  establishment, 
installation  or  storage  facility,  or  any  part  thereof  if  its  or  their  continued  use  will 
involve  an  imminent  risk  of  a major  accident. 

35 

2. 

1. 

Member  States  may  prohibit  the  use  or  bringing  into  use  of  any  establishment, 
installation  or  storage  facility,  or  any  part  thereof  under  this  Article  if: 

- 

the  operator  has  not  submitted  the notification,  reports  or  other  information  required 
by  the  Directive  within  the  specified  period; 

-  an  external  emergency  plan  has  not  been  prepared  within  the  specified  period. 

In  accordance  with  their  own  legal  systems  Member  States  shall  ensure  that  if  the 
competent  authority  prohibits  the  use  or  bringing  into  use  of  any  establishment, 
installation  or  storage  facility,  or  any  part  thereof  because  an  external  emergency  plan 
has  not  been  prepared  within  the  specified  period,  the  operator  is  entitled  to  seek 
compensation  from  the  authorities  responsible  for  the preparation  of  such plans  for  any 
costs  incurred  due to  the  prohibition. 

Member  States  shall  ensure  that  operators  may  appeal  against  the  prohibition  by  a 
competent authority mentioned in paragraph  1, according to national law and procedures, 
to  an  appropriate  body.  On  such  an  appeal  the  prohibition  may  be  cancelled,  amended 
or  confirmed.  During  such  appeal  the  prohibition  imposed  by  the  competent  authority 
shall  remain  in  force. 

Article  18 

Member  States  shall  ensure  that  the  competent  authorities  organize  a  system  of 
inspections, or other  measures  of  control  proper  to the type of  establishment  concerned. 
Those inspections or  control  measures  shall  not be dependent  upon  receipt of the  safety 
report or any other report submitted.  Such inspections or other  control measures shall be 
sufficient  for  a  planned  and  systematic  examination  of  the  systems  being  employed  at 
the  establishment,  whether  of  a technical,  organizational  or  managerial  nature,  so as to 
ensure  in  particular: 

- 

- 

- 

that  the  operator  can  demonstrate  that  he  has  taken  appropriate  measures,  in 
connection  with the various  activities involved  in the establishment,  to prevent  major 
accidents; 

that the operator  can  demonstrate that he has provided  appropriate  means for  limiting 
the  consequences  of  major  accidents, on  site  and  off  site; 

that the data and  information  contained  in the  safety  report  specified  in  Article  9(1), 
or any other report submitted, adequately  reflects  the conditions in the  establishment; 

- 

that  information  has  been  supplied  to  the  public  pursuant  to  Article  13(1). 

36 

2. 

The  system  of  inspection  specified  in  paragraph  1  shall  comply  with  the  following 
conditions: 

(a) 

It  shall  be  conducted  by  a  suitably  qualified  and  trained  person  employed  by  the 
competent  authority. 

(b)  Inspections  shall  be  undertaken  by  suitably  qualified  and  trained  persons.. 

(c)  A programme  of inspections for  all establishments. Unless the competent  authority 
has  established  a  programme  of  inspection  which  provides  for  a  longer  period 
between  inspections  based  upon  a  systematic  appraisal  of  the  major-accident 
hazards  of  the  particular  establishment  concerned,  the  programme  shall  entail  at 
least  one  on-site  inspection  made  by  the  competent  authority  every  12 months  to 
each  establishment  covered  by  Article  9. 

(d)  Following  each  inspection  a  report,  including  conclusions  and  follow-up  action, 
shall  be prepared  by  the person  carrying  out  the  inspection,  for  submission  to  and 
consideration  by  the  manager  appointed  by  the  competent  authority. 

(e)  Every  inspection  carried  out  by  the  competent  authority  shall  be  followed  up with 
the  management  of  the  establishment,  no  later  than  three  months  following  the 
inspection. 

The competent  authority  may  require the operator to provide any  additional  information 
necessary  to  allow  the  authority  fully  to  assess  the  possibility  of  a major  accident  and 
to  determine  the  scope  of  possible  increased  probability  and/or  aggravation  of  major 
accidents,  to  permit  the  preparation  of  an  external  emergency  plan,  to  provide 
information  concerning  siting  and  land  use,  and  to  take  substances  into  account  which, 
due  to  their  physical  form,  particular  conditions  or  location,  may  require  additional 
consideration. 

Member States shall ensure that sufficient  and appropriate resources, including  financial, 
technical  and  human  resources,  are  put  at  the  disposal  of  the  competent  authority,  the 
authority designated for the establishment of the External Emergency Plans and any other 
authority  designated  by the Member  State  to  achieve the objectives  of,  and to  carry  out 
an  activity  required  by, this  Directive. 

Member  States  shall  inform  the  Commission  of  the  criteria  they  apply  for  the 
establishment  and  management  of 
inspection  programmes  and  procedures.  The 
Commission  shall adopt, if necessary, harmonized criteria under the procedure laid down 
in  Article  22. 

3. 

4. 

5. 

37 

Article  19 

1. 

The  Commission  shall  set  up  and  keep  at the  disposal  of  Member  States  a register  and 
information  system  containing,  in  particular,  details  of  the  major  accidents  which  have 
occurred  within  the  territory  of  Member  States,  for  the  purpose  of: 

(a) 

the  rapid  dissemination  of  the  information  supplied  by  Member  States pursuant  to 
Article  15(1) among  all  competent  authorities; 

(b)  distribution  to competent authorities of an analysis of the causes of  major  accidents 

and  the  lessons  learned  from  them; 

(c)  supply  of  information  to  competent  authorities  on  preventive  measures; 

(d)  provision  of  information  on  organizations  able  to  provide  advice  or  relevant 
information  on  the  occurrence,  prevention  and  mitigation  of  major  accidents. 

The  register  and  information  system  shall  contain,  at  least: 

(a) 

the  information  supplied  by  Member  States  in  compliance  with  Article  15(1); 

(b)  an  analysis  of  the  causes  of  the  accidents; 

(c) 

the  lessons  learned  from  the  accidents; 

(d) 

the  preventive  measures  necessary  to  prevent  a  recurrence. 

2. 

3. 

Access to the register  and information  system  shall  be open  to government  departments 
of  the  Member  States,  industry  or  trade  associations,  trade  unions,  non-governmental 
organizations  in  the  field  of  the  protection  of  the  environment,  and  other  international 
or  research  organizations  working  in  the  field. 

Member  States shall provide the Commission  with  an annual  report on the numbers  and 
types  of  establishments  covered  by  Articles  6  and  9,  the  number  of  safety  reports 
received,  the  number  of  Internal  and  External  Emergency  Plans  produced,  and  the 
number  of  inspections  made.  The  Commission  shall  publish  a  summary  of  this 
information  every  year. 

Article  20 

1. 

Information  obtained by the competent  authorities  and by the Commission  in  pursuance 

of  this  Directive  is confidential  only  so  far  as  it  affects: 

- 

the confidentiality  of the proceedings of competent authorities and of the Commission; 

- 

the  confidentiality  of  international  relations  and  national  defence; 

38 

-  public  security  or other security  aspects; 

-  matters  which  are  or  have  been  sub  judice.  or  under  investigation  (including 
investigation 

disciplinary  inquiries),  or  which  are  the  subject  of  preliminary 
proceedings; 

-  commercial  and industrial  confidentiality,  including  intellectual  property; 

-  the  confidentiality  of  personal  data and/or  files; 

-  material  supplied by  a third party without that party's being  under a legal  obligation 

to  do so. 

2. 

This Directive  shall not preclude the conclusion by a Member State of agreements  with 
third countries on the exchange of information to which it is privy at internal level other 
than that obtained through the  Community  procedures for the exchange of  information 
set up by mis Directive. 

Article 21 

The procedure specified  in Article 22 shall be used for the adaptation of the Annexes to technical 
progress  and for  establishing:  the  harmonized  Community  criteria referred  to  in  Articles  8(3), 
9(8),  11(7),  14(3)  and  18(5);  the  guidelines  referred  to  in  Article  12(3)  and  the  report  form 
referred to in Article  15(2). 

Article  22 

Wherever  reference  is  made to this Article, the following  procedure  shall  be applied: 

The  Commission  shall  be  assisted  by  a  committee  of  an  advisory  nature  composed  of  the 
representatives  of  the Member  States and chaired by  the representative  of  the  Commission. 

The representative  of  the  Commission  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, if necessary  by taking a vote. 

The opmion shall be recorded in the minutes; in addition, each Member State shall have the  right 
to  ask to have  its position  recorded  in the minutes. 

The Commission shall take the utmost account of the opinion delivered by the committee. It shall 
inform  the committee  of the manner in which  its opinion  has been taken into account. 

Directive  82/501/EEC  is hereby  repealed with  effect  from  1 January  1996. 

Article  23 

39 

Article  24 

1.  Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative  provisions 
necessary  to  comply  with  this  Directive  on  1 January  1996.  They  shall  forthwith  notify  the 
Commission  thereof. 

When  Member  States adopt these provisions, these  shall  contain  a reference  to this  Directive 
or  shall  be  accompanied  by  such  reference  at  the  time  of  their  official  publication.  The 
procedure  for  such  reference  shall  be  adopted  by  Member  States. 

2.  Member  States  shall  communicate  to  the  Commission  the  provisions  of  national  law  which 

they  adopt  in  the  field  covered  by  this  Directive. 

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

Article  25 

This Directive  is  addressed  to  the  Member  States. 

Article  26 

Done  at Brussels, 

For  the  Council 
The  President 

40 

ANNEX  1 

APPLICATION  OF  THE  DIRECTIVE 

This Annex  applies to the presence  of Dangerous  Substances  at any  establishment  as defined  by 
this  Directive,  and  determines  the  application  of  the  relevant  articles. 

The  presence  of  Dangerous  Substances  in  the  context  of  this  Directive  includes  where  their 
presence,  above  the  relevant  threshold  quantity,  is provided  for  or  when  Dangerous  Substances 
are  likely  to  be  present  above  threshold  quantities  as  a  result  of  an  accident. 

Mixtures  and  preparations  shall  be  treated  in  the  same  way  as  pure  substances  provided  they 
remain  within  concentration  limits  set  according  to  their  properties  under the  relevant  Directive 
or  latest  adaptation  to  technical  progress  given  in  note  1,  unless  a  percentage  composition  or 
other  description  is  specifically  given. 

The  qualifying  quantities  set  out  below  relate to  each  establishment. 

The  quantities  to  be  considered  for  the  application  of  the  rélevant  articles  are  the  maximum 
quantities  which  are  present  or  are  liable  to  be  present  at  any  one  time.  Dangerous  substances 
present  at an establishment  solely  in an isolated  quantity  equal  to or less than  2% of the relevant 
qualifying  quantity  shall be ignored for  the purposes of calculating the total  quantity  present.  An 
isolated  quantity  refers  to  a quantity  of  dangerous  substance  itself  incapable  of  causing  a  major 
accident,  and  located  within  an  establishment  such  that  it  cannot  act  as  an  initiator  of  a  Major 
Accident  elsewhere  on  the  site. 

The  rules  given  in  note  4  governing  the  addition  of  Dangerous  Substances,  or  categories  of 
Dangerous  Substance  shall  apply  where  appropriate. 

41 

PART  1: Named  Substances 

Where  a substance  or  group  of  substances  listed  in  Part  1 also  falls  within  a category  of  Part  2, 
the  qualifying  quantities  set  out  in  Part  1 must  be  used. 

COLUMN  1 

COLUMN  2 

COLUMN  3 

Dangerous  Substances 

Qualifying  quantity  (tonnes) 
for  the  application  of 

Ammonium  nitrate0) 

Ammonium  nitrate(2) 

Articles  6/7 

350 

1  250 

Arsenic  pentoxide, 
Arsenic(V)  acid  and/or  salts 

0.5 

Arsenic  trioxide, 

Arsenious  (III)  acid  and/or  salts 

0.1 

Bromine 

Chlorine 

Dinickel  trioxide 

Dioxins 

(excluding  TCDD) 

Ethyleneimine 

Fluorine 
Formaldehyde(>90%) 
Hydrogen 

20 

10 

1 

0.1 

10 

10 
5 
5 

Article  9 

2  500 

5  000 

0.5 

0.1 

100 

25 

1 

0.1 

50 

25 

50 

50 

0) 

(2) 

This  applies  to  ammonium  nitrate  and  mixtures  containing  ammonium  nitrate  where  the 
nitrogen  content  derived  from  the  ammonium  nitrate  is  greater  than  28% by  weight  (other 
than  those  covered  by footnote  No 2) and  aqueous  solutions of  ammonium  nitrate where  the 
concentration  of  ammonium  nitrate  is greater  than  90% by  weight. 
This  applies  to  straight  ammonium  nitrate  fertilizers  which  comply  with  Directive 
80/876/EEC, and to compound fertilizers, where the nitrogen content derived from  ammonium 
nitrate  is  greater  than  28%  by  weight  (a  compound  fertilizer  contains  ammonium  nitrate 
together  with  phosphate  and/or  potash). 

42 

COLUMN 1 

COLUMN  2 

COLUMN 3 

Dangerous  Substances 

Qualifying  quantity  (tonnes) 
for the  application  of 

Articles  6/7 

Article  9 

Hydrogen  chloride 
(liquefied  gas) 

Hydrogen  fluoride  (50%) 

Hydrogen  sulphide 

Lead Alkyls 

Liquefied  Petroleum  Gas 
(including  propane  and butane) 

4,  4'  Methylenebis(2-chloraniline) 

and/or salts 

Methylisocyanate 

Natural  gas or other 

combustible  gases 

Nickel  monoxide 

Nickel  dioxide 

Nickel  sulphide 

Oxygen 

Sulphur dichloride 

Sulphur trioxide 

25 

5 

5 

5 

50 

0.01 

0.15 

50 

1 

1 

1 

200 

1 

15 

Tetrachlorodibenzodioxine 

0.001 

Triniçkel  disulphide 

1 

43 

250 

50 

50 

50 

200 

0.01 

0.15 

200 

1 

1 

1 

2 000 

1 

75 

0.001 

1 

COLUMN  1 

COLUMN  2 

COLUMN  3 

Dangerous  Substances 

Qualifying  quantity  (tonnes) 
for  the  application  of 

Articles  6/7 

Article  9 

The  following  CARCINOGENS: 

0.001 

0.001 

4-Aminobiphenyl  and/or  its  salts, 
Benzidine  and/or  salts, 
Bis(chloromethyl)  ether, 
Chloromethyl  methyl  ether, 
Dimethylcarbamoyl  chloride, 
Dimethylnitrosomine, 
Hexamethylphosphoric  triamide, 
2-Naphthylamine  and/or  salts,  and 
1, 3  Propanesultone 
4-nitrodiphenyl 

44 

PART  2:  Categories  of  substances  and  preparation  not  specifically  named  in  Part 1 

COLUMN  I 

COLUMN  2 

COLUMN  3 

Categories  of  dangerous 
substances,  classified 

Qualifying  quantity  (tonnes) 
for  the  application  of 

Articles  6/7 

Article  9 

1. VERY  TOXIC 

2.  TOXIC 

3.  OXIDISING 

4.  EXPLOSIVE  (where  the  substance 
or  preparation  falls  within  the 
definition  given  in  note  2 a) 

5.  EXPLOSIVE  (where  the  substance 
or  preparation  falls  within  the 
definition  given  in  note  2 b) 

6.  FLAMMABLE  (where 
the  substance  or  preparation 
falls  within  the  definition 
given  in  note  3 a) 

7a. HIGHLY  FLAMMABLE  (where 
the  substance  or  preparation 
falls  within  the  definition 
in  given  note  3b) 

7b.  HIGHLY  FLAMMABLE  liquids 
(excluding  substances  or 
preparations  covered  by  7a) 

5 

50 

50 

50 

10 

20 

200 

200 

200 

50 

5 000 

50 000 

50 

200 

5 000 

50 000 

8. EXTREMELY  FLAMMABLE  (where 
the  substance  or  preparation 
falls  within  the  definition 
given  in  note  3 c) 

10 

50 

45 

COLUMN  1 

COLUMN  2 

COLUMN  3 

Categories  of  dangerous 
substances,  classified 

Qualifying  quantity  (tonnes) 
for  the  application  of 

Articles  6/7 

Article  9 

9.  DANGEROUS  FOR  THE  ENVIRONMENT 

in  combination  with  risk  phrases: 

i)  R50  "Very  Toxic  to  aquatic 

organisms" 

ii)  R51  "Toxic  to  aquatic 
organisms";  and 
R53  "May  cause  long  term 
adverse  effects  in  the 
aquatic  environment" 

10.  Any  classification  not 
covered  by  those  given 
above  in  combination  with 
risk  phrases 

i)  R14  - Reacts  violently 

with  water  (including  R14/15) 

ii)  R29  -  Contact  with  water 

liberates  toxic  gas 

500 

2 000 

5 000 

20 000 

100 

50 

500 

200 

46 

NOTES 

1.  Substances and Preparations are classified  according to the following  Directives (as amended) 

and  their  current  Adaptation  to  Technical  Progress: 

Council  Directive  67/548/EEC  on  the  approximation  of  the  laws,  regulations  and 
administrative  provisions  relating  to  the  Classification,  Packaging  and  Labelling  of 
Dangerous  Substances; 

Council  Directive  88/379/EEC  on  the  approximation  of  the  laws,  regulations  and 
administrative provisions  of the Member  States  relating to the  Classification,  Packaging 
and  Labelling  of  Dangerous  Preparations; 

Council  Directive  78/631/EEC  on  the  approximation  of  the  laws  of  the  Member  States 
relating  to  the  Classification,  Packaging  and  Labelling  of  Dangerous  Preparations 
(pesticides). 

In  the  case  of  substances  and  preparations  which  are  not  classified  according  to  any  of  the 
above  Directives  but  which  nevertheless  are  present,  or  are  liable  to  be  present,  in  an 
establishment  and  which  possess  or  are  liable  to  possess,  under  the  conditions  found  at  the 
establishment,  equivalent  properties  in  terms  of  major  accident  potential, the procedures  for 
provisional  classification  shall be followed  according to the relevant article of the  appropriate 
Directive. 

In  the  case  of  Substances  and  Preparations  with  properties  giving  rise  to  more  than  one 
classification,  for  the  purposes  of  this  Directive,  the  lower  thresholds  shall  apply. 

For the purposes of this Directive a list providing information  on Substances and Preparations 
shall  be established,  kept  up to  date, and  approved  by the procedure  set up  under  Article 22. 

2.  An  EXPLOSIVE  means: 

(a)  a  solid  or  liquid  substance  or  mixture  of  solid  or  liquid  substances  or  both,  which  is 
capable  of  detonation,  that  is  the  production  of  a  large  volume  of  gas  at  supersonic 
velocity  from  a  small  volume  of  solid  or  liquid;  or 

a  solid  or  liquid  substance  or  mixture  of  solid  or  liquid  substances  or  both  which  is 
designed  to produce  a propellant  effect  by  releasing  a large  quantity  of  gas  at  subsonic 
velocity  from  a  small  volume  of  solid  or  liquid; 

(b)  notwithstanding  substances or preparations covered by the definition  given  in 2(a), those 
substances  and  preparations  classified  as  EXPLOSIVE  according  to  note  1  in 
combination  with  risk  phrase  R3  "Extreme  risk  of  explosion  by  shock,  friction,  fire  or 
other  sources of  ignition",  and  all other  substances  and preparations  which  can  produce 
an  effect  by  explosion. 

47 

3.  FLAMMABLE, HIGHLY  FLAMMABLE  and EXTREMELY  FLAMMABLE  in  categories 

6, 7 and 8 mean: 

(a)  FLAMMABLE liquids; 

substances and preparations having a flash  point equal to or greater than  21°C and less 
than or equal to  55°C, supporting  combustion; 

(b)  HIGHLY FLAMMABLE liquids; 

substances and preparations which may become hot and finally  catch fire in contact with 
air  at  ambient  temperature  without  any  input of  energy,  and  substances  which  have a 
flash  point  lower than  55°C and which  remain  liquid  under pressure, where particular 
processing  conditions,  such  as high  pressure  and  high  temperature,  may  create  major 
accident hazards; 

(c)  EXTREMELY  FLAMMABLE  gases and liquids; 

liquid  substances  and  preparations  which  have  a  flash  point  lower  than  0°C  and  the 
boiling  point  (or  in  the  case  of  a  boiling  range  the  initial  boiling  point)  of  which  at 
normal  pressure  is  less than  or  equal  to  35°C, EXCLUDING  gasoline  and  petroleum 
spirits which  shall be covered by category  7b; and 

gaseous substances and preparations which are flammable  in contact with air at ambient 
temperature  and  pressure  whether  or  not  kept  in  the  gaseous  or  liquid  state  under 
pressure, EXCLUDING Liquefied  Petroleum Gas (including propane and butane) which 
shall be treated  according to their listing in Part  1. 

4.  The addition of Dangerous Substances to determine the quantity present at an establishment 

shall be carried out according to the following  rule: 

If the sum: 

Qi/Q  +  q2/Q  +  q3/Q  +  q4/Q  +  q5/Q  + 

> 

i 

where o^ = 

the  quantity  of  dangerous  substance  or  category  of  dangerous  substance 
falling  within Parts  1 or 2 of this Annex, x present 

Q  = 

the relevant threshold  quantity  from  Parts  1 or 2. 

then the establishment  is covered by the relevant  requirements  of the Directive. 

48 

This  rule  will  apply  for  the  following  circumstances: 

(a) 

for substances and preparations appearing in Part  1  at quantities less than their individual 
qualifying  quantity  present  with  substances  having  the  same  classification  from  Part  2, 
and the addition of substances and preparations with the same classification  from  Part  2; 

(b)  for  the  addition  of  categories  1, 2,  and  10 present  at  an  establishment  together; 

(c) 

for  the  addition  of  categories  3,  4,  5,  6,  7a,  7b,  and  8,  present  at  an  establishment 
together. 

49 

ANNEX  2 

DATA  AND INFORMATION  TO BE CONSIDERED IN THE  SAFETY  REPORT  SPECIFIED 
IN  ARTICLE  9 

1.  Information  relating  to  the  establishment  including: 

(a) 

the geographical location of the establishment and predominant meteorological  conditions 
and  sources  of  danger  arising  from  its  location; 

(b) 

the  maximum  number  of  persons  working  at  the  establishment  and  particularly  those 
persons  exposed  to  the  Major  Accident  hazard,  and  an  indication  of  the  maximum 
number  of  persons  likely  to  be  present  at  the  establishment  at  any  one  time; 

(c)  a general  description  of  the  technological  processes  for  each  installation; 

(d)  a  description  of  the  sections  of  the  establishment  which  are  important  from  the  safety 
point  of  view, the  sources  of  Major  Accident  hazard  and  the  conditions  under  which  a 
major  accident  could  occur,  together  with  a  description  of  the  preventative  measures 
planned; 

2.  Information  relating  to  the  Dangerous  Substances  at  each  installation  or  storage  or  present 
elsewhere  at  the  establishment  and  liable  to  be  significant  in  creating  a  Major  Accident 
Hazard: 

(a)  composition  of  the  Dangerous  Substances  present  in  significant  quantities,  including, 
chemical  name,  CAS  number,  name  according  to  IUPAC  nomenclature,  other  names, 
empirical  formula,  degree  of  purity  and  the  main  impurities  and * their  relative 
percentages; 

(b) 

the  quantity  (order  of  magnitude),  of  the  dangerous  substance,  or  substances,  present; 

(c)  methods and precautions laid down by the operator  in connection  with handling,  storage 

and  fire; 

(d)  methods  available  to  the  operator  for  rendering  the  substance  harmless; 

(e)  an indication  of the hazards, both  immediate  and  delayed for  man  and the  environment; 

(f) 

the  chemical  and/or  physical  behaviour  under  normal  conditions  of  use  during  the 
process; 

(g) 

the forms  in which the substances  may  occur  or into  which they  may  be transformed  in 
the  case  of  abnormal  conditions  which  can  be  foreseen. 

50 

3. 

Information  relating  to  the  installation  or  storage: 

(a) 

(b) 

(c) 

(d) 

detection  and  determination  methods  available,  including  a  description  of  the 
methods  used  or  the  references  in  the  scientific  literature; 

the  stage  at  which  the  dangerous  substances  are  or  may  be  involved  in  the 
installation; 

if  necessary,  other  dangerous  substances  whose  presence  could  have  an  effect  on 
the  potential  Major  Accident  hazard  presented; 

the  arrangements  made  to  ensure  that  the  technical  means  necessary  for  the  safe 
operation  of the installation  or  storage  and to  deal  with  any  malfunctions  that  arise 
are  available  at  all  times. 

4. 

Information  relating  to  possible  major  accidents: 

(a) 

(b) 

(c) 

details  of  the  main  possible  major  accident  scenarios  including  consideration  of 
knock-on  effects  involving  adjacent  installations, storage, or  establishments  and an 
assessment, in general terms, of the likelihood  of its happening, taking into  account 
the  preventative  and  mitigatory  actions  taken; 

a  summary  of  the  events  which  could  be  significant  in  bringing  about  each  of 
these  scenarios  together  with  an  assessment  of  the  extent  and  severity  of  the 
consequences; 

emergency  measures  laid  down  by  the  operator  in  the  event  of  accidental 
dispersion,  including  the  internal  emergency  plan  prepared  in  compliance  with 
Article  11. 

5. 

Information  relating  to  the  management  system  and  organization  of  the  establishment,  as 
it  relates  to  Major  Accident  prevention,  preparedness  and  response: 

(a) 

(b) 

(c) 

(d) 

a  summary  of  the  operator's  Major-Accident  Prevention  Policy  as  required  by 
Article  6; 

a summary  of the organizational  structure for implementing the aims and  objectives 
of the Major-Accident  Prevention Policy, including the position  and names of those 
persons  with  significant  responsibilities  and  their  relevant  duties; 

the  management  systems  used  to  monitor,  audit  and  review 
the  content  and 
implementation  of  the Major-Accident  Prevention  Policy,  including  the  evaluation 
of  safety  performance; 

analysis of the training needs of the individuals  responsible  for  the  implementation 
and  monitoring  of  the  Major-Accident  Prevention  Policy; 

51 

(e) 

(f) 

(g) 

(h) 

a  summary  of  the  safety  critical  procedures,  including  an  assessment  of  possible 
human  error,  for  the  operation,  maintenance,  and  emergency  preparedness  of  the 
establishment  and  individual  installations  or  storage; 

the  procedures  adopted  for  planning  modifications  to  the  existing  installations  or 
storage  or  the  design  of  a new  installation  or  storage; 

the  involvement  of  the  workforce,  including  that  of  any  contractors,  in  the  Major-
Accident  Prevention  Policy,  its  implementation  and  assessment; 

the internal  system  for  reporting  major  accidents or  near  misses, particularly  those 
involving  failure  of  protective  measures,  and  their  investigation  and  follow  up. 

52 

ANNEX  3 

DATA AND INFORMATION TO BE INCLUDED IN THE EMERGENCY PLANS  SPECIFIED 
UNDER  ARTICLE  11 

1. 

INTERNAL  EMERGENCY  PLANS. 

(a) 

(b) 

(c) 

(d) 

(e) 

Names  or  positions  of  persons  authorised  to  set  emergency  procedures  in  motion 
and  the  person  in  charge  of  and  coordinating  the  on  site  mitigatory  action. 

Name  or  position  of  the  person  with  responsibility  for  liaising  with  the  authority 
responsible  for  the  external  emergency  plan. 

For  foreseeable  conditions  or  events  which  could  be  significant  in  bringing  about 
a  major  accident,  a description  of  the  action  which  should  be  taken  to  control  the 
conditions or events and to limit their  consequences, including  a description  of the 
safety  equipment  and  the  resources  available. 

Arrangements  for  limiting the  risks  to persons  on  site including  how  warnings  are 
to  be  given  and  the  actions persons  are  expected  to  take on  receipt  of  a  warning. 

Arrangements  for  providing  early  warning  of  the  incident  to  the  authority 
responsible  for  setting  the  external  emergency  plan  in  motion,  the  type  of 
information  which  should  be contained  in  an  initial  warning  and the  arrangements 
for  the provision  of  more  detailed  information  as  it becomes  available. 

(f) 

Arrangements  for  training  staff  in the duties they  will be  expected  to perform,  and 
where  necessary  coordinating  this  with  off  site  emergency  services. 

(g) 

Arrangements  for  providing  assistance  with  off  site  mitigatory  action. 

2.  EXTERNAL EMERGENCY PLANS. 

(a) 

(b) 

(c) 

Names  or  positions  of  persons  authorised  to  set  emergency  procedures  in  motion 
and  of  persons  authorised  to  take  charge  of  and  coordinate  off  site  action. 

Arrangements  for  receiving  early  warning  of  incidents,  and  alert  and  call  out 
procedures. 

Arrangements  for  coordinating  resources  necessary  to  implement  the  external 
emergency  plan. 

(d) 

Arrangements  for  providing  assistance  with  on  site  mitigatory  action. 

53 

(e) 

Arrangements  for  off  site  mitigatory  action 

(f) 

(g) 

Arrangements  for  providing  the  public  with  specific  information  relating  to  the 
incident  and  the  behaviour  which  it  should  adopt. 

Arrangements  for  the provision  of  information  to  the  emergency  services  of  other 
Member  states  in  the  event  of  a  major  accident  with  possible  transboundary 
consequences. 

54 

ANNEX  4 

ITEMS OF INFORMATION  TO BE COMMUNICATED  TO THE PUBLIC IN  APPLICATION 
OF  ARTICLE  13(1) 

1 

2 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

Name  of  occupier  and  address  of  the  establishment. 

Identification,  by  position  held,  of  the person  giving  the  information. 

Confirmation  that  the  establishment  is  subject  to  the  regulations  and/or  administrative 
provisions implementing  the Directive  and that the notification  referred  to in Article 6(3), 
or  the  Safety  Report  referred  to  in  Article  9(1)  has  been  submitted  to  the  Competent 
Authority. 

An explanation in simple terms of the activity or activities undertaken  at the  establishment. 

The common names or, in the case of dangerous substances covered by Part 2 of Annex  1, 
the  generic  names  or the  general  danger  classification  of  the  substances  and  preparations 
involved at the establishment which  could give rise to a major  accident, with  an indication 
of  their  principal  dangerous  characteristics. 

General  information  relating  to  the nature  of  the  major-accident  hazards,  including  their 
potential  effects  on  the  population,  and  the  environment. 

Adequate information  on how the population  concerned  will be warned and kept  informed 
in  the  event  of  a  major  accident. 

Adequate  information  on  the  actions  the  population  concerned  should  take,  and  on  the 
behaviour  they  should  adopt,  in  the  event  of  a  major  accident. 

Conformation  that  the  operator  is  required  to  make  adequate  arrangements  on  site, 
including  liaison  with  the  emergency  services,  to  deal  with  major  accidents  to  minimise 
their  effects. 

10.  A reference to the external emergency plan drawn up to cope with any off-site  effects  from 
an accident. This should include advice to cooperate with any instructions or requests  from 
the  emergency  services  at  the  time  of  an  accident. 

11.  Details of where  further  relevant  information  can  be obtained, subject  to the  requirements 

of  confidentiality  laid  down  in  national  legislation. 

55 

IMPACT ASSESSMENT  FORM 

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 CONTROL  OF  MAJOR 
ACCIDENT  HAZARDS  INVOLVING  DANGEROUS  SUBSTANCES  (COMAH) 

The  Proposal 

1. Why  is Community  Legislation necessary  in this area ? 

Following  ten  years  of  experience  with  the  provisions  of  Council 
Directive  82/501/EEC  on  the  major  accident  hazards  of  certain 
industrial  activities,  study  of  the  situation  in  the  Community  has 
shown  that  a  fundamental  revision  of  the  directive  is  now  necessary. 
The  Council  in  its  accompanying  resolution  to  the  Fourth  European 
Community  Action  Programme  on  the Environment  called  for more  effective 
implementation  of  the  directive,  greater  exchange  of  information 
between  Member  States  and  review,  including  possible  widening  of  the 
scope. 

In the 5th  Environmental  Action  Programme,  "Towards  SustainabiIity, The 
European  Communities  Programme  of  Policy  and  Action  in Relation  to  the 
Environment  and  Sustainable  Development",  two  common  features  of  the 
programme,  including  the control  of  industrial  risks, are: 

- 

the  involvement  of  all  levels  of  society  in  the  spirit  of 
shared  responsibility, and, 

in order  to  ensure  that  Community  measures  on  the  environment 
are  more  effectively 
implemented,  cooperation  procedures 
between  the  Commission  and  the Member  States  should  be  further 
improved. 

The  Commission  services  have  examined  the  provisions  of  Council 
Directive  82/501/EEC,  as  amended,  and,  in  consultation  with  experts 
from  Member  States,  industry  and  other  interested  parties  investigated 
ways  in which  the existing  provisions  should  be  revised. 

56 

The  examination  of  the  existing  provisions,  in particular  the  practical 
application  of  the  provisions  in  the  Member  States,  and  the  major 
accidents  which  have  occurred  in  the  Community  over  the  past  ten  years, 
shows  that  certain  elements  were  missing  from  the  original  directive 
and  that  certain  other  requirements  require  revision  in  the  light  of 
changing  technology. 

The  main  aim  of  the  proposal  is  to  provide  for  a  high  level  of 
and  the  public 
protection  for  health,  safety,  the  environment 
("consumers"). 

This  aim  is  achieved  in  the  proposal  by  the  introduction  of  the 
following  three  elements  throughout  the  text; 

a)  A  single  application  system  based  upon  one  application  annex  and 
thresholds  for  all  establishments  where  dangerous  substances  are 
present. 

b)  The  inclusion  of  provisions  on  land  use  planning  as  it  relates  to 
Major  Accidents. 

c) The  inclusion  of  Management  systems  and  human  factors  throughout  the 
text  particularly  by  the  introduction  of  a  Major  Accident  Prevention 
Policy,  and  greater  consideration  of  these  matter  in  the  Safety  report 
required  under  Article  9. 

The  Impact  on  Business 

2.  Who  will  be  affected  by  the  proposal  and  what  will  they  have  to  do  ? 

The  Directive  will  apply  to  all  occupiers  of  establishments  where 
dangerous  substances  are  present  (including  dangerous  substances 
present  as  a  result  of  an  accident)  above  a  defined  threshold. 
Establishments  are  defined  therefore  in wider  terms  than  the  activities 
covered  under  the  provisions  of  Council  Directive  82/501/EEC.  The 
establishment  includes  installations  and  storage  facilities  covered 
under  the  existing  requirements  and  could  also  add  other  types  of 
premises  where  dangerous  substances  are  present 
in  sufficient 
quantities  to  create  a  major  accident  hazard,  such  as  laboratories, 
large  agricultural  stores  etc. 

The  concerns  expressed  by  some  sections  of  industry  and  other 
interested  parties  about  the  inclusion  of  these  types  of  establishment 
were  considered  in  the  proposal  by  the  use  of  sufficiently  high 
thresholds  in  annex  1  so  as  to  prevent  very  small  enterprises  being 
covered  where  a  major  accident  hazard  clearly  does  not  exist,  whilst 
maintaining  equal  treatment  for  all  parts  of  industry  which  create  an 
equal  major  accident  hazard. 

57 

All  establishments  covered  by  the  proposal  will  have  a  general 
requirement  to  prevent  major  accidents.  This  will  therefore  be 
applicable  equally  to  multinational 
businesses  and  SMEs.  The 
requirement  is  identical  to  the  existing  requirement  of  Council 
Directive  82/501/EEC  Article  3  except  that  whereas  in  the  original 
directive  it  applied  without  a  lower  threshold  in  the  new  proposal  it 
only  applies  to  establishments  above  the  article  6/7  threshold.  This 
is  in  recognition  of  the  requirements  of  the  various  directives  made 
under  Article  118A of  the Treaty  and  to better  target  the  directive  at 
major  hazard  installations. 

There  are essentially  two  levels of more  specific  requirements  proposed 
in the  revised  Directive. 

The  first  requirement  under  Articles  6  and  7  will  apply  to 
establishments  where  dangerous  substances  are  present  in  quantities 
greater  than  the  thresholds  given  in column  2 of  either  parts  1 or  2 of 
Annex  1. 
Occupiers  of  these  establishments  will  have  to  produce  an 
internal  Major  Accident  Prevention  Policy  (MAPP)  and  provide  a  simple 
notification  to  the  Competent  Authorities.  The  thresholds  chosen  for 
the  application  of  these  requirements  are,  in  the  majority  of  cases, 
identical  to  the  thresholds  previously  used  in  Council  Directive 
82/501/EEC  for  isolated  storage.  It will  be applicable  to multinational 
businesses  and  some SMEs. 

The  second  level  of  application,  based  upon  Article  9,  will  apply  to 
establishments  where  dangerous  substances  are  present  in  quantities 
greater  than  the  thresholds  given  in column  3 of  either  parts  1 or  2 of 
Annex  1.  It  will  be  applicable  mostly  to  the  larger  businesses  and 
multinational  companies.  Occupiers  of  these,  Article  9,  establishments 
will  have  to  produce  a  safety  report,  which  is  submitted  to  the 
Competent  Authority,  and  an  internal  emergency  plan.  They  are  also 
subject  to  external  emergency  planning,  siting  and  land  use  planning 
requirements  and  requirements  relating  to  the  provision  of  information 
to  the  public. The  requirements  of  the  safety  report  have  been  updated 
to  include management  systems  and  human  factors.  In other  respects  the 
requirements  are  identical  to  those under  Council  Directive  82/501/EEC. 

The  requirement  on  siting  and  land  use  planning  is new  and  based  upon 
the  common  aspects  of  land  use  planning  currently  used  by  some  Member 
States. 

Under  the  current  requirements  of  article  5  of  Council  Directive 
82/501/EEC  approximately  2500  establishments  in  the  Community  are 
subject  to  the  requirement  to  produce  a  safety  report.  The  thresholds 
chosen  for  the  application  of  Article  9  of  this  proposal  are  in  the 
majority  of  cases  identical  to  the  thresholds  used  previously,  and 
therefore  the  Commission  services  do  not  expect  a significant  increase 
in the number  of  businesses  covered. 

Certain  concerns  were  expressed  by  industry  and  other  interested 
parties  regarding  the  inclusion  of  "DANGEROUS  FOR  THE  ENVIRONMENT"  and 
"CARCINOGENS"in  the  application  annex,  and  the  inclusion  of  management 
systems  and  sanctions  for  inspectors.  There  were  also  some  concerns 
regarding  the overlap  of  this proposal  with  other  Community  initiatives 
or  legislation.  All  these  concerns  have  been  addressed,  in  a  balanced 
way,  in the proposal. 

58 

The new category  of  "DANGEROUS  FOR  THE  ENVIRONMENT"  has been  introduced 
in part  2 of  annex  1 of  the proposal  but  thresholds  have  been  proposed 
for  this  category  which  are  high  enough  to  effectively  eliminate  all 
except  the  largest  establishments,  until  such  time  that  further 
information  on  the  major  accident  hazards  of  substances  classified  as 
Dangerous  for  the Environment  is available. 

CARCINOGENS  have  been  included  in  the  proposal  in an  identical  fashion 
to  the  existing  requirements  of  Council  Directive  82/501/EEC  by  naming 
certain  category  1 and  2 carcinogens  in part  1 of  annex  1. 

The  inclusion  of  management  systems  is  an  essential  feature  of  the 
proposal  since  study  of  major  accidents  occurring  in  the  Community 
indicates  that  95% of  these  accidents  have,  as  their  underlying  cause, 
management  error.  The  proposal  does  not,  however,  seek  to  impose 
particular  methods  of  management,  rather  it  emphasises  the  need  for 
good management  in all  its forms. 

The  inclusion  of  sanctions  for  inspectors  has  been  proposed  given  the 
need  to ensure  equivalent  practical  implementation  across  the  Community 
and  to prevent  establishments  creating  an  unacceptable  risk  of  a major 
accident  occurring. The proposal  also  addresses  the question of  overlap 
between  various  Community  requirements  by  providing  a  flexibility  in 
the  production  of  the  safety  report.  This  flexibility  allows  occupiers 
to  used  reports  prepared  for  other  purposes  as  part  of  the  safety 
report, provided  the objectives of  the  report  are  maintained. 

3. What  Economic  Effects  is the Proposal  Likely  to have ? 

The harmonisation of measures  to provide  a high  level  of  protection  for 
health,  safety,  the environment  and  the public  (consumers)  in the  field 
of  major  accident  hazards  is  difficult  quantify.  However  various 
studies  have  demonstrated  that  the  costs  both  to  industry  and  society 
in  general  of  one  major  accident  such  as  Bhopal  can  be  very 
signi f icant. 

The  measures  proposed  in  this  directive,  in  addition  to  the  measures 
already  required  under  the  provisions  of  Council  Directive  82/501/EEC, 
include  the  requirement  to  prepare  an  internal  Major  Accident 
Prevention  Policy  (MAPP),  to  improve  management  systems  generally  and 
to  include  new  information  on  these  systems  within  the  safety  report 
produced  by  the  largest  establishments  covered.  Since  the  measures 
proposed  reflect,  to  a  large  extent,  the  practices  of  the  best 
companies  in  this  field  who  find  that  there  are  often  production 
benefits  from  introducing  good  management  systems  the  calculation  of 
the cost  to  industry  is further  complicated. 

The  current  average  cost  to  industry  to  produce  a  safety  report  under 
Council  Directive  82/501/EEC  has  been  estimated  to  be  between  50  000 
and  125  000  ECUS  depending  upon  the  size  of  the  establishment. 
Estimates  for  the  inclusion  of  the  additional  matters  relating  to 
management  systems  and  human  factors  range  between  5  000  and  25  000 
ECUS.  However  this  increase  can  be  offset  by  the  potential  savings 
produced  from  the  prevention  of  Major  Accidents.  This  is  particularly 
relevant  following  the  study  of  the  Major  Accidents  indicating  the 
underlying  cause was management  error. 

59 

Given  the  potential  advantages  to  society,  the  environment,  the 
economy,  and  specifically  to  the  business  concerned  of  the  prevention 
of  even  one  major  accident,  and  the  additional  harmonising  measures 
proposed  in  the  directive  there  should  be  a  considerable  advantage  to 
all  interested  parties. There  may  be  some  additional  costs  for  certain 
sectors  of  industry  primarily  in  those  Member  States  which  presently 
have  less  stringent  standards  of  practical  implementation  of  the 
current  requirements.  However  these  additional  costs  are  offset  by  a 
certain  flexibility  in  the  requirements  for  businesses  able  to 
demonstrate  to  the  satisfaction  of  the  Competent  Authority  that  they 
have  adequately  dealt  with  the  particular  hazard  or  it  is  of  no 
relevance  to  them.  Those  businesses  will  be  able,  for  example,  to 
reduce  the amount  of  information  presented  in future  safety  reports. 

4.  Does  the  Proposal  Contain  measures  to  take  account  of  the  specific 
situât ion of  SMEs ? 

The  proposal  is  targetted  at  high  hazard  establishments.  Normally 
these  will  be  managed  by  large  multinational  companies  and  so  the 
specific  situation  of  SMEs  is  naturally  taken  into  account.  However 
those  SMEs  that  might  be  covered  will  need  to  adhere  to  the  same  basic 
principles  given  the  nature  of  the  hazard.  However  the  implementation 
of  control  measures will  be proportional  to  risk  and  the  sophistication 
of  the  management  systems  proportional  to  the  size  and  management 
structure. 

5.  Consultations. 

The  industrial  organisations  consulted  by  the  Commission  during  the 
development  of  this  proposal  between  October  1990  and  December  1991 
include,  The  European  Council  of  Chemical  Manufacturers'  Federations 
(CEFIC),  The Oil  Companies'  European  Organization  for  Environmental  and 
Health  Protection  (CONCAWE),  The Oil  Industry  International  Exploration 
and  Production  Forum  (E  &  P  FORUM),  The  European  Liquefied  Petroleum 
Gas  Association  (AEGPL),  Union  of  the  Gas  Industries  of  the  Common 
Market  (MARCOGAZ),  The  European  Federation  of  Chemical  Trade  (FECC), 
The  European  Petroleum  Industry  Association  (EUROPIA),  The  European 
Industrial  Gases  Association  (EIGA),  The  International  Group  of 
National  Associations  of  Manufacturers  of  Agrochemical  Products 
(GIFAP),  EUROMETAUX,  and  The  Federation  of  European  Explosives 
Manufacturers  (FEEM). 

Other  consultations  have  included  The  European  Trade  Union  Technical 
Bureau  for  Health  and  Safety,  and  The  European  Trade  Union  Institute 
(ETUi). 

The  majority  of  consultations  have  been  constructive  and  have  resulted 
in  improvements  to  the  proposal. 

60 

ISSN 0254-1475 

COM(94)4finaI 

DOCUMENTS 

EN 

10  14 

Catalogue number : CB-CO-94-016-EN-C 

ISBN 92-77-64566-0 

Office  for Official  Publications of the European Communities 
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