Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on control of major-accident hazards involving dangerous substances
Date: 2010-12-21
Institutions: European Commission
Subjects: accident prevention, dangerous substance, environmental risk prevention, industrial hazard, public health, safety standard

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EUROPEAN COMMISSION 

Brussels, 21.12.2010 
COM(2010) 781 final 

2010/0377 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

on control of major-accident hazards involving dangerous substances 

SEC(2010) 1590 final 
SEC(2010) 1591 final 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

Grounds for and objectives of the proposal 

Directive  96/82/EC  on  the  control  of  major-accident  hazards  involving  dangerous 
substances  (hereinafter  the  Seveso  II  directive)  is  aimed  at  preventing  major 
accidents involving large quantities of dangerous substances (or mixtures thereof) as 
listed in its Annex I and to limit the consequences of such accidents for man and the 
environment. There is a tiered approach to the level of controls, with the larger the 
quantities of substances, the stricter the rules. 

The Directive has to be amended due to changes in the EU system of classification of 
dangerous substances to which the Directive refers. In the light of this, it was decided 
in  2008  to  launch  a  wider  review  since  the  basic  structure  of  the  Directive  and  its 
main requirements have remained essentially unchanged since its adoption. Although 
the review has shown that that overall the existing provisions are fit for purpose and 
that no major changes are required, a number of areas were identified where limited 
amendments  would  be  appropriate  in  order to  clarify  and  update  certain  provisions 
and  to  improve  implementation  and  enforceability  while  maintaining  or  slightly 
increasing the level of protection for health and environment. 

The proposal is intended to address these issues. 

General context 

Industrial  accidents  involving  dangerous  substances  often  have  very  serious 
consequences.  Some  well-known  major  accidents 
like  Seveso,  Bhopal, 
Schweizerhalle,  Enschede,  Toulouse  and  Buncefield  have  taken  many  lives  and/or 
damaged  the  environment  and  cost  up  to  billions  of  euro.  In  the  wake  of  these 
accidents, political awareness has sharpened towards recognising the risks and taking 
appropriate precautionary action to protect citizens and communities.  

The  Seveso  II  Directive,  which  covers  around  10,000  establishments  within  the 
European Union, has been instrumental in reducing the likelihood and consequences 
of chemical accidents. However there is continuing need to ensure that existing high 
levels of protection are maintained and if possible further improved. 

Existing provisions in the area of the proposal  

The current provisions are those established by the Seveso II Directive. The aim is to 
revise those provisions. 

Consistency with other policies and objectives of the Union 

The main reason for the revision of the Seveso II Directive is to align its Annex I to 
Regulation  (EC)  No.  1272/2008  on  classification,  labelling  and  packaging  of 
dangerous substances and mixtures (hereinafter the CLP Regulation), which amends 
and repeals Directives 67/548/EEC and 1999/45/EC to which the Seveso II Directive 
currently refers. The CLP rules become definitive with effect from 1 June 2015. 

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2. 

CONSULTATION  OF 
ASSESSMENT 

INTERESTED 

PARTIES  AND 

IMPACT 

Consultation of interested parties 

During  the  review  process  over  the  last  two  years,  stakeholders  (individual 
companies, industry associations, NGOs, Member State competent authorities) were 
consulted  in  a  number  of  ways,  including  web-base  questionnaires  available  for  all 
stakeholders; consultation of competent authorities in the Member States through the 
regular  meetings  of  the  committee  of  competent  authorities  (CCA)  and  related 
seminars;  on  the  Annex  I  alignment,  via  a  multi-stakeholder  technical  working 
group,  comprising  experts  from  Member  States,  industry  and  environmental  NGOs 
(the  technical  report  from  which  is  available  on  DG  ENV's  website);  and  a 
stakeholder consultation meeting held on 9 November 2009 in Brussels, attended by 
around  60  representatives  from  national  and  European  industry  and  environmental 
NGOs  as  well  as  individual  companies,  following  which  around  fifty  written 
submissions were received.  

There was general agreement that no major changes to the Directive are necessary. 
There  was  broad  support  in  principle  for  further  clarifying  and  updating  the 
provisions, although views varied on specifics. 

Further details can be found in the impact assessment and on DG ENV's website at 
http://ec.europa.eu/environment/seveso/review.htm). 

Collection and use of expertise 

As  part  of  the  review  process,  several  studies  were  carried  out  by  external 
contractors. These included two  studies assessing the effectiveness  of the  Directive 
and  two  studies  supporting  the  impact  assessment  of  the  economic,  social  and 
environmental impacts of the various policy options. 
The findings from the three-yearly implementation reports from Member States were 
also taken into account. 

Further details can be found in the impact assessment and on DG ENV's website at 
http://ec.europa.eu/environment/seveso/review.htm). 

Impact assessment 

The  main  problems  covered  in  the  impact  assessment  related  to  the  alignment  of 
Annex I to the CLP Regulation and the impact on the scope of the Directive, which 
was the key issue. Related to that issue were possible other technical amendments to 
Annex I and the procedures for adapting Annex I in the future. Other issues related to 
information  to  the  public  and  information  management  systems  and  land-use 
planning,  where  experience  of  implementation  to  date  indicates  that  some 
opportunities  for  improvements  or  new  requirements  may  exist;  and  other  detailed 
provisions  which  could  usefully  be  clarified  or  updated,  in  some  cases  to  more 
closely reflect existing practices. 

The  impact  assessment  assessed  a  number  of  policy  options  with  the  aim  of 
identifying  a  cost-effective  package  of  measures  to  address  these  issues.  The 
assessment has led the Commission to propose a number of amendments, of which 
the main ones are as follows. 

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As  regards  the  alignment  of  Annex  I,  a  simple  change  of  reference  or  one-to-one 
translation from the old classification system to the CLP Regulation is not possible, 
mainly because for health hazards the old hazard classification categories 'toxic' and 
'very  toxic'  do  not  correspond  to  the  new  CLP  'Acute  Toxicity'  1  to  3,  which  are 
moreover  divided  into  different  exposure  routes  (oral,  dermal  and  inhalation).  A 
further  complication  is  that  as  substances  are  classified  or  re-classified  under  the 
CLP Regulation over time, this will automatically impact on the scope of the Seveso 
legislation.  The  Commission  is  proposing  the  option  that,  in  addition  to  a  very 
limited  impact  on  scope  shared  with  other  options,  maintains  a  high  level  of 
protection  taking  into  account  the  most  likely  and  relevant  exposure  routes  in  the 
event  of  a  major  accident.  To  deal  with  situations  arising  over  time  from  the 
alignment where substances are included/excluded under the Directive that do/do not 
present a major-accident hazard, a package of corrective mechanisms to adapt Annex 
I via delegated acts is proposed.  

As  regards  information  to  the  public,  etc,  it  is  proposed  to  improve  the  level  and 
quality of information and how this is collected, managed, made available, updated 
and  shared  in  an  efficient  and  streamlined  way.  This  will  bring  the  Directive  more 
into line with the Aarhus Convention on access to information, public participation in 
decision-making  and  access  to  justice  in  environmental  matters,  update  its 
procedures to take account of advances in information management systems such as 
the internet and the ongoing efforts to improve the efficiency of such systems like the 
Shared  Environmental  Information  System  (SEIS)  initiative  and  the  INSPIRE 
Directive (2007/2/EC). 

The  remaining  amendments  proposed  are  relatively  minor  technical  adaptations  to 
existing provisions. 

Taken as a whole, the potential changes considered represent a moderate adaptation 
of the Directive and would not significantly affect the level of protection or the costs 
of the Directive. Overall, the costs of these are low compared with the total costs of 
the Directive. 

The impact assessment is submitted with this proposal. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

Summary of the proposed action 

The aim of the proposal is to revise the Directive to align it to the CLP Regulation 
and  also  to  clarify,  improve  or  add  certain  provisions  to  ensure  better,  more 
consistent  implementation  and  enforcement  of  the  legislation  with  the  aim  of 
achieving a high level of protection, while where possible simplifying legislation and 
reducing administrative burdens. 

Legal basis 

The  primary  objective  of  the  Directive  is  the  protection  of  the  environment.  This 
proposal is therefore based on Article 192(1) TFEU.320 

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Subsidiarity principle 

The  subsidiarity  principle  applies  insofar  as  the  proposal  does  not  fall  under  the 
exclusive competence of the Union.  

The objectives of the proposal cannot be sufficiently achieved by the Member States 
since the Seveso II Directive sets goals and objectives for the prevention and control 
of  major  accidents  throughout  the  European  Union.  This  principle  is  maintained  in 
the  current  proposal.  In  addition,  many  major  accidents  can  have  transboundary 
effects. All Member States could be affected by such accidents and therefore need to 
take measures in order that the risks to the population and the environment in each 
Member State can be reduced. XXXX 

Community action will better achieve the objectives of the proposal because of the 
need  to  avoid  significantly  different  levels  of  protection  in  the  Member  States, 
particularly  in  view  of  possible  distortions  of  competition  that  could  result.  The 
proposal leaves the detailed means of implementation, compliance and enforcement 
to be decided by the appropriate authorities.3 

The proposal therefore complies with the subsidiarity principle. 

Proportionality principle 

The  proposal  complies  with  the  proportionality  principle  for  the  following 
reasons.331It  follows  the  goal-setting  approach  of  the  Seveso  II  Directive,  leaving 
sufficient flexibility to the Member States to determine how to achieve the objectives 
laid down. The new provisions do not go beyond what is necessary and the current 
proportionate  approach,  with  the  level  of  controls  based  on  the  quantities  of 
dangerous substances present in establishments, is maintained. 
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Choice of instrument 

The  proposed  instrument  is  a  directive.34Given  the  fact  that  the  existing  legislation 
sets Community objectives while leaving the choice of measures for compliance to 
the Member States, the best instrument is a directive. Given the nature and extent of 
the changes compared with the current Directive, a revision of that in the form of an 
amending Directive or recast would not be appropriate. A new directive is therefore 
proposed. 

4. 

BUDGETARY IMPLICATION 

The proposal has no implication for the Community budget. 

5. 

ADDITIONAL INFORMATION 

Simplification 

Some  elements  of  the  proposal  should  help  to  reduce  unnecessary  administrative 
burden, in particular by encouraging, at Member State level, coordinated inspections, 
more integration in information and procedural requirements, and by simplifying and 
streamlining  implementation  reporting  requirements  through  moving  towards  an 

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extended  shared  information  system.  Clarifications  to  existing  provisions  will  also 
improve readability and give greater legal certainty. 

Repeal of existing legislation 

The adoption of the proposal will lead to repeal of the existing Directive. 
Correlation table 

The  Member  States  are  required  to  communicate  to  the  Commission  the  text  of 
national provisions transposing the Directive as well as a  correlation table between 
those provisions and this Directive.560 

European Economic Area 

The  proposed  act  concerns  an  EEA  matter  and  should  therefore  extend  to  the 
European Economic Area.570 

Detailed explanation of the proposal 

The  following  provides  information  about  the  specific  Articles.  Except  where 
indicated otherwise, the provisions are unchanged in substance from those set out in 
Directive 96/82/EC. 

Article 1 

This Article outlines the aim and objectives of the Directive. 

Article 2 

Article 2 defines the scope of the Directive, which applies to establishments where 
dangerous substances listed in Annex I are present above prescribed thresholds. The 
provisions of Article 2 are essentially unchanged from Directive 96/82/EC. However 
the order of Parts 1 and 2 of Annex I has been reversed so that Part 1 of Annex I lists 
categories  of  dangerous  substances  according  to  their  generic  hazard  classification 
(in  accordance  with  the  CLP  Regulation)  and  part  2  lists  named  dangerous 
substances  or  groups  of  substances  that,  notwithstanding  their  generic  hazard 
classification, warrant specific listing. 

The main differences in terms of content of the Annex are as follows. 

The  main  change  concerns  health  hazards.  The  former  category  "Very  Toxic"  has 
been aligned to the CLP category "Acute Toxic 1" and "Toxic" to "Acute Toxic 2" 
(all exposure routes) and "Acute Toxic 3" (dermal and inhalation routes).  

Several more specific CLP categories for physical hazards that did not exist before 
replace  the  more  general  old  categories  for  oxidizing,  explosive,  and  flammable 
hazards.  These,  together  with  the  environmental  hazard  categories,  represent  a 
straightforward translation and maintain the current scope in relation to such hazards 
as  closely  as  possible.  For  the  new  category  of  flammable  aerosols,  the  thresholds 
have  been  adapted  proportionately  to  those  that  apply  currently  based  on  their 

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flammable properties and components; and for reasons of consistency, the group of 
pyrophoric substances has been completed by the inclusion of pyrophoric solids.  

The new Annex I Part 2 retains the old Part 1 largely unchanged. The only changes 
are  an  updated  reference  to  the  CLP  Regulation  for  liquefied  flammable  gases;  the 
inclusion of anhydrous ammonia, boron triflouride, and hydrogen sulphide as named 
substances,  previously  covered  by  their  hazard  categories,  to  keep  their  thresholds 
unchanged;  the  inclusion  of  heavy  fuel  oil  in  the  entry  for  petroleum  products; 
clarifications to the notes in relation to ammonium nitrate; and an update of the toxic 
equivalency factors for dioxins. 

Furthermore the exclusions to the Directive previously listed in Article 4 of Directive 
96/82/EC are listed here. These are maintained, subject to the following changes: 

– 

– 

to  remove  any  possible  doubts,  the  exception  to  the  exclusion  for  the 
exploitation  of  minerals  in  mines  and  quarries  or  boreholes  is  amended  to 
include underground gas storage. 

the  possibility  to  exclude  substances  from  being  regarded  as  dangerous 
substances  for  the  purposes  of  the  Directive  because  they  do  not  present  a 
major-accident hazard (see Article 4). 

Among the excluded areas are the offshore exploration and exploitation of minerals, 
including  hydrocarbons.  As  announced  in  its  recent  communication  "Facing  the 
challenge of the safety of offshore oil and gas operations" in the light of the oil rig 
accident in the Gulf of Mexico, the Commission will assess the appropriate way to 
strengthen  environmental  legislation  with  provisions  that  may  be  necessary  to 
complement  existing  environmental  legislation  in  relation  to  pollution  control, 
inspection  and  accident  prevention  and  management  as  regards  individual  offshore 
installations, ensuring a high level of protection of the environment in such activities. 
Corresponding  legislative  proposals  will  include  either  extending  the  scope  of 
existing legislation to offshore oil and gas installations or a stand-alone initiative for 
such operations. 

Article 3 

This Article defines the basic terms used in the Directive. Compared with Directive 
96/82/EC, the following changes should be highlighted: 

– 

– 

– 

the definitions of "establishment" and "operator" have been clarified, with the 
latter  brought  more  into  line  with  the  definition  in  the  Industrial  Emissions 
Directive. 

the  reference  to  ‘presence  of  dangerous  substances’  in  Article  2  of  Directive 
96/82/EC is moved to this Article 

definitions are added for the different kinds of establishments falling within the 
Directive's  scope  and  "inspections".  Definitions  are  also  included  for  "the 
public"  and  "the  public  concerned",  in  line  with  the  EU  legislation 
implementing the Aarhus Convention. 

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– 

the  definition  of  "installation"  is  clarified  to  make  it  clear  that  underground 
installations are included. 

Article 4 

lead 

This new Article provides for correction mechanisms to adapt Annex I as necessary 
via delegated acts. This is needed in particular to address unwanted effects from the 
alignment  of  Annex  I  to  the  CLP  Regulation  and  subsequent  adaptations  to  that 
Regulation,  which  could 
to  substances  and  possibly  mixtures  being 
automatically included in or excluded from the Directive irrespective of whether or 
not  they  present  a  major  accident  hazard.  The  mechanisms  would  take  the  form  of 
EU-wide  substance  derogations  and  establishment-specific  derogations  at  Member 
State level on the basis of harmonised criteria for substances/mixtures that are caught 
but  should  be  excluded,  and,  as  a  counterpart,  a  safeguard  provision  enabling  the 
inclusion of non-captured hazards. The criteria for the derogations would be based on 
those  laid  down  in  Commission  Decision  98/433/EC  and  would  be  established  by 
delegated acts by 30 June 2013. 

Article 5 

This  Article  repeats  the  existing  requirements  of  Article  5  of  Directive  96/82/EC, 
which set out the general obligations on operators. 

Article 6 

This Article extends the information obligations in relation to notifications set out in 
Article  6  of  Directive  96/82/EC  to  include  information  about  neighbouring 
establishments, etc, whether or not they are covered by the Directive, needed for the 
purposes  of  Article  8  relating  to  domino  effects.  In  addition  operators  will  be 
required  to  update  their  notifications  at  least  every  five  years.  All  this  will  help 
competent authorities to manage implementation of the Directive more effectively. 

Article 7 

Article 7 of Directive 96/82/EC is amended to make it clear that all establishments 
must have a major-accident prevention policy (MAPP) proportionate to the hazards. 
The scope of the MAPP and its relationship with safety management systems (SMS) 
pursuant to Article 9 and Annex III is also clarified, by deleting the reference to the 
latter. 

New  provisions  are  introduced  requiring  that  the  MAPP  should  be  available  in 
writing  and  sent  to  the  competent  authority  and  that  it  should  be  updated  at  least 
every five years, in line with the proposed frequency for updating notifications under 
Article 6. 

Article 8 

This  Article  covers  so-called  domino  effects.  It  maintains  the  obligation  on 
competent authorities to identify those establishments that are so close together that 
the consequences of a major accident are increased. However the text is clarified to 
make it clear that the provisions apply to both upper- and lower-tier establishments 
and  that  the  key  aim  is  to  ensure  that  operators  exchange  information  with 

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neighbouring  establishments,  including  those  that  fall  outside  the  scope  of  the 
Directive. 

Article 9 

This Article maintains the core requirement for upper-tier establishments to prepare a 
safety  report,  previously  contained  in  Article  9  of  Directive  96/82/EC.  The  main 
change is to clarify the relationship with the MAPP and SMS, particularly in respect 
of  the  obligations  for  lower-tier  establishments  in  the  latter  regard.  The  need  for  a 
proportionate approach is also highlighted. 

The  content  of  the  safety  report  is  detailed  in  Annex  II  and  remains  largely 
unchanged (see below). The need for the report to demonstrate that possible major-
accident scenarios have been taken into account is also underlined. 

As regards the safety management system (SMS), changes are introduced in Annex 
III  (see  below)  to  remove  the  references  to  the  MAPP,  which  lower-tier 
establishments are required to have. At the same time it is underlined that the SMS, 
in particular for a lower-tier establishment, should a Member State so require, should 
be proportionate to the hazards and risks. 

The provisions for periodic updating of the safety report are maintained, but with an 
express requirement  for such updated reports to be communicated without delay to 
the competent authorities. 

Article 10 

This Article requires operators to update their managements systems and procedures 
and,  in  particular,  their  MAPP  and  safety  report  in  the  event  of  significant 
modifications within their establishment. Minor changes are introduced in line with 
changes made to related provisions. 

Article 11 

Article 11 maintains the requirements relating to emergency planning for upper-tier 
establishments previously set out in Article 11 of Directive 96/82/EC, subject to two 
minor modifications: to require that public consultation on external emergency plans 
is  in  line  with  the  principles  of  the  relevant  provisions  of  Directive  2003/35/EC 
implementing  the  Aarhus  Convention;  and  to  make  clearer  the  separation  of 
responsibilities between operators and competent authorities in relation to the review, 
testing and updating of internal and external emergency plans. In addition, to avoid 
significant  delays  in  the  completion  of  plans,  which  are  an  essential  in  terms  of 
adequate preparedness and response in the event of accidents, a new obligation is for 
the  competent  authority  to  draw  up  the  external  emergency  plan  within  12  months 
after receipt of the necessary information from the operator. 

Annex  IV  details  the  information  to  be  contained  in  the  plans  and  carries  over  the 
requirements  laid  down  in  the  corresponding  Annex  in  Directive  96/82/EC,  with 
certain amendments (see below). 

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Article 12 

This  Article  contains  the  provisions  relating  to  land-use  planning.  It  is  essentially 
unchanged from Directive 96/82/EC apart from minor changes such as to clarify that 
the aim is to protect the environment as well as human health and that it applies to all 
establishments; to provide for measures other than safety distances (which may not 
be  appropriate)  to  protect  areas  of  particular  natural  sensitivity  or  interest;  and  to 
provide  where  possible  for  integration  of  land-use  planning  procedures  with  those 
under the Environmental Impact Assessment Directive and similar legislation; and to 
provide the possibility for competent authorities to require lower-tier establishments 
to provide sufficient risk-related information for the purposes of land-use planning. 
These  changes  will  bring  the  text  more  into  line  with  its  aims  and  more  closely 
reflect existing practice. 

Article 13 

This  Article  retains  the  current  requirements  that  information  should  actively  be 
made  available  to  persons  liable  to  be  affected  by  a  major  accident  and  also  kept 
permanently  available.  It  leaves  open  who  is  responsible  for  the  provision  of  such 
information.  The  main  changes  are  to  extend  the  information  to  include  basic 
information for all establishments (name, address and activities), which is provided 
to the Commission under Article 19 of the current Directive, but is not made publicly 
available;  and  for  upper-tier  establishments,  a  summary  of  the  major-accident 
scenarios  and  key  information  from  the  external  emergency  plan;  and,  without 
precluding other forms of communication, to have this information kept permanently 
available  to  the  public  online  and  provided  to  a  central  database  at  Union  level  as 
provided for in Article 20. 

Confidentiality  of  information  is  ensured,  where  necessary  and  appropriate,  by 
Article 21. 

These changes will make it easier for the public to access relevant information and 
be better informed in the vent of an accident. It will also make it easier for competent 
authorities to monitor that information is available and kept up to date. 

Article 14 

This is a new Article that builds on and extends the requirements laid down in Article 
13(5)  of  the  current  Directive  requiring  that  the  public  should  be  able  to  give  its 
opinion  in  certain  cases  relating  to  land-use  planning,  modifications  to  existing 
establishments,  external  emergency  plans,  etc.  The  provisions  are  largely  based  on 
Directive 2003/35/EC, with the aim to bring the Seveso II Directive more into line 
with the corresponding provisions of the Aarhus Convention. 

Articles 15 and 16 

These  two  Articles  relate  to  the  reporting  of  major  accidents  by  operators  and 
competent authorities respectively. The main change is setting a 12 months deadline 
for the submission of reports to avoid lengthy delays in the reporting of accidents by 
Member  States.  This,  and  a  change  to  the  quantity  threshold  set  out  in  Annex  VI, 
which establishes the criteria for reportable accidents (see below), will aid prevention 
of  future  accidents  by  allowing  early  reporting  and  analysis  of  accidents  and  near-

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misses  involving  significant  high  quantities  of  dangerous  substances  so  that 
information and lessons learned can be shared. 

Articles 17,18,19 and 27 

These  Articles  maintain  and  build  upon  the  existing  provisions  relating  to  the  role 
and responsibilities of competent authorities with the aim of ensuring more effective 
implementation and enforcement. 

Article  17  introduces  a  requirement  for  Member  States  with  more  than  one 
competent authority to appoint one to take the lead in coordinating activities. It also 
sets  out  arrangements  for  cooperation  between  the  competent  authorities  and  the 
Commission in activities in support of implementation, using the existing committee 
of competent authorities ("the forum") and related technical working groups, such as 
development  of  guidance,  exchanges  of  best  practices  and  consideration  of 
notifications made pursuant to Article 4. 

Article 19 strengthens the existing requirements in relation to inspections. The new 
provisions  are  largely  based  on  Recommendation  2001/331/EEC  providing  for 
minimum  criteria  for  environmental  inspections  in  the  Member  States  and  the 
Industrial  Emissions  Directive.  The  importance  of  making  available  sufficient 
resources  for  inspections,  and  the  need  to  encourage  exchange  of  information,  for 
example  at  Union  level  through  the  current  Mutual  Joint  Visits  Programme  for 
inspections, is underlined. 

Articles 18 and 27 (which is new) set out the measures to be taken in the vent of non-
compliance, including prohibitions of use and other penalties. 

Article 20 

This  Article  relates  to  the  availability  of  information  on  establishments  and  major 
accidents held by the Commission. The main change is that provisions of the current 
Directive  are  improved  and  strengthened  by  extending  the  current  Seveso  Plants 
Information  Retrieval  System  (SPIRS  )  database  to  include  the  information  to  the 
public referred to in Article 13 and Annex V and to make that database open to the 
public. Access could be either through links to documents directly loaded on to the 
system  or  through  links  to  the  websites  of  Member  States  and/or  operators.  This 
sharing  of  information  would  help  to  ensure  that  the  public  has  the  necessary 
information and allow operators and competent authorities to draw lessons from the 
best practices of others.  

The database would also be used for the purposes of reporting on implementation by 
Member States, which would streamline and simplify the current arrangements.  

Article 21 

This sets out new rules on confidentiality, which are based on Directive 2003/4/EC 
implementing  the  provisions  of  the  Aarhus  Convention  relating  to  public  access  to 
environmental 
information,  which  place  greater  weight  on  openness  and 
transparency  while  providing  for  non-disclosure  of  information  in  duly  justified 
cases where confidentiality is required such as for security reasons. 

EN 

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Article 22 

This Article is a new provision, bringing the Directive more into line with the Aarhus 
Convention by requiring that Member States should ensure that the public concerned, 
including  interested  environmental  NGOs,  have  access  to  administrative  or  judicial 
review to challenge any acts or omissions that could breach their rights in relation to 
access  to  information  pursuant  to  Articles  13  and  21(1)  or  consultation  and 
participation in decision-making in relation to cases under Article 14. 

Articles 23 to 26 

Article  23  provides  that  Annexes  I  to  VII  will  be  adapted  to  technical  progress  by 
delegated acts (which will also be used to establish criteria for derogation pursuant to 
Article  4(4) and the granting  of derogations for substances to be listed in Part 3 of 
Annex  I).  The  other  Articles  are  standard  provisions  relating  to  the  exercise  of  the 
delegation  of  such  implementing  powers,  and  the  procedures  for  revocation  and 
objections. 

Articles 28 to 31 

These Articles concern transposition by Member States, entry into force of the new 
Directive and repeal of Directive 96/82/EC. The date on which Member States shall 
apply the Directive, 1 June 2015, is the date on which the CLP Regulation becomes 
definitive. 

Other Annexes 

Annex II contains the items to be considered in the safety report required by Article 
9. The  content  of  the  different  parts  of the Annex  are  largely unchanged compared 
with Annex II in Directive 96/82/EC. The main changes are additional requirements 
in relation to information about neighbouring establishments, in particular in view of 
possible domino effects, and other external risks and hazards, such as environmental 
risks  and  hazards  (point  C  of  Part  1  and  point  A  of  Part  4);  about  lessons  learned 
from past accidents (point C; Part 4); and about equipment to limit the consequences 
of major accidents (point A, part 5).  

Annex  III  relates  to  the  information  on  management  systems  and  organisational 
factors  to  be  covered  in  the  safety  report.  The  main  changes  are  to  remove  the 
references  to  the  MAPP,  to  clarify  that  the  safety  management  system  should  be 
proportionate  and  that  internationally  recognised  systems  such  as  ISO  and  OSHAS 
should  be  taken  into  account;  and  to  include  references  to  safety  culture.  Another 
change is a reference to the possible use of safety performance indicators, which can 
be  an  effective  tool  to  improve  safety  and  assist  in  monitoring,  assessment  and 
enforcement,  and  to  necessary  changes  to  be  made  following  audit  and  review  of 
safety management systems. 

Annex  IV  sets  out  the  information  to  be  included  in  the  internal  and  external 
emergency plans required under Article 11. It is identical to Annex IV in Directive 
96/82/EC  save  that  the  scope  of  the  external  emergency  plan  is  extended  to  make 
clearer  references  to  the  need  to  address  possible  domino  effects  and  off-site 
mitigatory actions to address major accident scenarios impacting on the environment. 

EN 

12 

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Annex V lists the information to be provided to the public in accordance with Article 
13. The main changes to the list of requirements are in Part 1, for all establishments, 
the inclusion of the following: details of information about major-accident hazards as 
set out in the MAPP or safety report (point 5), inspections carried out (point 6) and 
where  further  information  can  be  obtained  (point  7);  and  in  Part  2,  for  upper-tier 
establishments, the inclusion of the main types of major-accident scenarios (point 1), 
appropriate  information  from  the  external  emergency  plan  (  point  5)  and  where 
appropriate transboundary impacts (point 6). 

Annex VI is essentially the same as that in the current Directive, listing the criteria 
for  reporting  accidents.  The  only  change  is  to  bring  more  accidents  within  the 
reporting system by reducing the quantity threshold laid down in section 1.1 to 1% of 
the upper-tier threshold. 

Annex VII will list the criteria for granting derogations pursuant to article 4. In 
accordance with Article 4(4), these criteria shall be adopted by delegated act by 30 
June 2013. 

EN 

13 

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2010/0377 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

on the control of major-accident hazards involving dangerous substances 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 192(1) thereof, 

Having regard to the proposal from the Commission1, 

After transmission of the draft legislative act to the national parliaments, 

Having regard to the opinion of the European Economic and Social Committee2, 

Having regard to the opinion of the Committee of the Regions3, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

Council  Directive  96/82/EC  of  9  December  2006  on  the  control  of  major-accident 
hazards involving dangerous substances activities4 lays down rules for the prevention 
of  major  accidents  which  might  result  from  certain  industrial  activities  and  with  the 
limitation of their consequences for human health and the environment. 

(2)  Major accidents often have serious consequences, as evidenced by accidents like Seveso, 
Bhopal, Schweizerhalle, Enschede, Toulouse and Buncefield. Moreover the impact can 
extend  beyond  national  borders.  This  underlines  the  need  to  ensure  that  appropriate 
precautionary action is taken to ensure a high level of protection throughout the Union 
for citizens, communities and the environment.  

(3) 

Directive 96/82/EC has been instrumental in reducing the likelihood and consequences 
of such accidents thereby leading to better protection levels throughout the Union. A 
review  of  the  Directive  has  confirmed  that  overall  the  existing  provisions  are  fit  for 
purpose and that no major changes are required. However, the system established by 
Directive 96/82/EC should be adapted to changes to the Union system of classification 

1 
2 
3 
4 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L 10, 14.1.1997, p. 13. 

EN 

14 

   EN 

                                                 
(4) 

(5) 

of dangerous substances to which it refers. In addition, a number of other provisions 
should be clarified and updated. 

It  is  therefore  appropriate  to  replace  Directive  96/82/EC  to  ensure  that  that  existing 
levels  of  protection  are  maintained  and  further  improved,  by  making  the  provisions 
more effective and efficient, and where possible reducing unnecessary administrative 
burdens  by  streamlining  or  simplification  without  compromising  safety.  At  the  same 
time,  the  new  provisions  should  be  clear,  coherent  and  easy  to  understand  to  help 
improve implementation and enforceability. 

The  Convention  on  the  Transboundary  Effects  of  Industrial  Accidents  of  the  United 
Nations  Economic  Commission  for  Europe,  which  was  approved  on  behalf  of  the 
Union by 98/685/EC: Council Decision of 23 March 1998 concerning the conclusion 
of the Convention on the Transboundary Effects of Industrial Accidents5, provides for 
measures  regarding  the  prevention  of,  preparedness  for  and  response  to  industrial 
accidents  capable  of  causing  transboundary  effects  as  well  as  for  international 
cooperation in this field. Directive 96/82/EC implements the Convention within Union 
law. 

(6)  Major  accidents  can  have  consequences  beyond  frontiers,  and  the  ecological  and 
economic cost of an accident is borne not only by the establishment affected but also 
by the Member state concerned. It is therefore necessary to take measures ensuring a 
high level of protection throughout the Union. 

(7) 

(8) 

(9) 

The provisions of this Directive should apply without prejudice to provisions of Union 
law as regards health and safety at work. 

Certain industrial activities should be excluded from the scope of this Directive due to 
their specific characteristics. These activities are subject to other legislation at Union 
or  national  level  providing  an  equivalent  level  of  safety.  The  Commission  should 
however continue to ensure that there are no significant gaps in the existing regulatory 
framework, in particular as regards new and emerging risks from other activities, and 
take appropriate action where necessary. 

Annex I to Directive 96/82/EC lists the dangerous substances falling within its scope, 
inter  alia  by  reference  to  certain  provisions  of  Council  Directive  67/548/EEC  of  27 
June 1967 on the approximation of the laws, regulations and administrative provisions 
relating to the classification, packaging and labelling of dangerous substances6 as well 
as  Directive  1999/45/EC  of  the  European  Parliament  and  of  the  Council  of  31  May 
1999  concerning  the  approximation  of  the  laws,  regulations  and  administrative 
provisions of the Member States relating to the classification, packaging and labelling 
of dangerous preparations7. Those Directives have been replaced by Regulation (EC) 
No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures8, which implements 
within the Union the Globally Harmonised System of Classification and Labelling of 
Chemicals (GHS) that has been adopted at the international level, within the structure 

5 
6 
7 
8 

OJ L 326, 3.12.1998, p. 1. 
OJ 196, 16.8.1967, p. 1. 
OJ L 200, 30.7.1999, p. 1. 
OJ L 353, 31.12.2008, p. 1. 

EN 

15 

   EN 

                                                 
of the United Nations. That Regulation introduces new hazard classes and categories 
only partially corresponding to those used under the previous arrangements. Annex I 
to  Directive  96/82/EC  therefore  needs  to  be  amended  to  align  it  to  that  Regulation 
while maintaining the existing levels of protection of that Directive. 

(10)  Flexibility is needed in order to be able to amend Annex I to deal with any unwanted 
effects  from  the  alignment  to  Regulation  (EC)  No  1272/2008  and  subsequent 
adaptations  to  that  Regulation  having  an  impact  on  the  classification  of  dangerous 
substances. On the basis of harmonised criteria to be developed, derogations could be 
granted where notwithstanding their hazard classification, substances do not present a 
major accident hazard. There should also be a corresponding correction mechanism to 
deal  with  substances  that  need  to  be  included  within  the  scope  of  this  Directive 
because of their major accident hazard potential. 

(11)  Operators should have a general obligation to take all necessary measures to prevent 
major accidents and to mitigate their consequences. Where dangerous substances are 
present  in  establishments  above  certain  quantities  the  operator  should  provide  the 
competent  authority  with  sufficient  information  to  enable  it  to  identify  the 
establishment,  the  dangerous  substances  present  and  the  potential  dangers.  The 
operator  should  also  draw  up  and  send  to  the  competent  authority  a  major-accident 
prevention policy setting out the operator's overall approach and measures, including 
appropriate safety management systems, for controlling major-accident hazards. 

(12) 

(13) 

In order to reduce the risk of domino effects, where establishments are sited in such a 
way  or  so  close  together  as  to  increase  the  probability  and  possibility  of  major 
accidents, or aggravate their consequences, operators should cooperate in the exchange 
of  appropriate  information  and  in  informing  the  public,  including  neighbouring 
establishments that could be affected. 

In  order  to  demonstrate  that  all  that  is  necessary  has  been  done  to  prevent  major 
accidents, to prepare contingency plans and response measures, 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 accident scenarios and risks analysis, 
prevention and intervention measures and the management systems available, in order 
to prevent and reduce the risk of major accidents and to enable the necessary steps to 
be taken to limit the consequences thereof. 

(14)  To  provide  against  emergencies,  in  the  case  of  establishments  where  dangerous 
substances are present in significant quantities, it is necessary to establish internal and 
external  emergency  plans  and  to  create  systems  to  ensure  those  plans  are  tested  and 
revised  as  necessary  and  implemented  in  the  event  of  a  major  accident  or  the 
likelihood  thereof.  The  staff  of  an  establishment  should  be  consulted  on  the  internal 
emergency plan and the public must be consulted on the external emergency plan. 

(15) 

In order to provide greater protection for residential areas, areas of substantial public 
use and the environment, including areas of particular natural interest or sensitivity, it 
is  necessary  for  land-use  or  other  relevant  policies  applied  in  the  Member  States  to 
take  account  of  the  need,  in  the  long  term,  to  keep  a  suitable  distance  between  such 
areas  and  establishments  presenting  such  hazards  and,  where  existing  establishments 

EN 

16 

   EN 

(16) 

are  concerned,  to  take  account  of  additional  technical  measures  so  that  the  risk  to 
persons is not increased. Sufficient information about the risks and technical advice on 
these risks should be taken into account when decisions are taken. Where possible, to 
reduce administrative burdens, procedures should be integrated with those under other 
Union legislation. 

In order to promote access to information on the environment, in accordance with the 
Aarhus Convention on access to information, public participation in decision-making 
and access to justice in environmental matters, which was approved on behalf of the 
Union by Council Decision 2005/370/EC of 17 February 2005 on the conclusion, on 
behalf  of  the  European  Community,  of  the  Convention  on  access  to  information, 
public  participation  in  decision-making  and  access  to  justice  in  environmental 
matters9,  the  level  and  quality  of  information  to  the  public  should  be  improved.  In 
particular, persons likely to be affected by a major accident should be given sufficient 
information to inform them of the correct action to be taken in that event. In addition 
to  providing  information  in  an  active  way,  without  the  public  having  to  submit  a 
request, and without precluding other forms of dissemination, it should also be made 
available  permanently  and  kept  up  to  date  on  the  internet.  At  the  same  time  there 
should be appropriate confidentiality safeguards, to address security-related concerns, 
among others. 

(17)  The  way  information  is  managed  should  be  in  line  with  the  Shared  Environmental 
Information  System  (SEIS)  initiative  introduced  by  Communication  from  the 
Commission  to  the  Council,  the  European  Parliament,  the  European  Economic  and 
Social  Committee  and  the  Committee  of  the  Regions  -  Towards  a  Shared 
Environmental  Information  System  (SEIS)10.  It  should  also  be  in  line  with  Directive 
2007/2/EC  of  the  European  Parliament  and  of  the  Council  of  14  March  2007 
establishing  an  Infrastructure  for  Spatial  Information  in  the  European  Community 
(INSPIRE)11  and  its  implementing  rules,  aimed  at  enabling  the  sharing  of 
environmental  spatial  information  among  public  sector  organisations  and  better 
facilitating public access to spatial information across the Union. Information should 
be  held  on  a  publicly  available  database  at  Union  level,  which  will  also  facilitate 
monitoring and reporting on implementation. 

(18) 

In line with the Aarhus Convention, effective public participation in decision-making 
is necessary to enable the public to express, and the decision-maker to take account of, 
opinions and concerns that may be relevant to those decisions, thereby increasing the 
accountability  and  transparency  of  the  decision-making  process  and  contributing  to 
public  awareness  of  environmental  issues  and  support  for  the  decisions  taken. 
Members of the public concerned should have access to justice in order to contribute 
to  the  protection  of  the  right  to  live  in  an  environment  that  is  adequate  for  personal 
health and well-being. 

(19) 

In  order  to  ensure  that  adequate  response  measures  are  taken  if  a  major  accident 
occurs,  the  operator  should  immediately  inform  the  competent  authorities  and 
communicate the information necessary for them to assess the impact of that accident. 

9 
10 
11 

OJ L 124, 17.5.2005, p. 1. 
COM(2008) 46 final. 
OJ L107, 25.4.2007, p. 1. 

EN 

17 

   EN 

                                                 
(20) 

In  order  to  provide  for  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 
analyze the hazards involved, and operate a system for the distribution of information 
concerning,  in  particular,  major  accidents  and  the  lessons  learned  from  them.  This 
information exchange should also cover 'near misses' which Member States regard as 
being of particular technical interest for preventing major accidents and limiting their 
consequences. 

(21)  Member  States  should  determine  the  competent  authorities  responsible  for  ensuring 
that operators fulfil their obligations. Where necessary, one authority should take the 
lead in coordinating the different authorities or other bodies involved. The competent 
authorities  and  the  Commission  should  cooperate  in  activities  in  support  of 
implementation  such  as  the  development  of  appropriate  guidance  and  exchanges  of 
best  practice.  To  avoid  unnecessary  administrative  burden,  where  appropriate 
information  obligations  should  be  integrated  with  those  under  other  relevant  Union 
legislation. 

(22)  Member States should ensure that competent authorities take the necessary measures 
in  the  event  of  non-compliance  with  this  Directive.  In  order  to  ensure  effective 
implementation and enforcement, there should be a system of inspections, including a 
programme  of  routine  inspections  at  regular  intervals  and  non-routine  inspections. 
Where  appropriate,  inspections  should  be  coordinated  with  those  under  other  Union 
legislation. It is important that sufficient qualified inspectors are available. Competent 
authorities  should  provide  appropriate  support  using  tools  and  mechanisms  for 
exchanging experience and consolidating knowledge, including at Union level. 

(23)  The  Commission  should  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  290  of  the  Treaty  in  respect  of  the  adoption  of  criteria  for  derogations  and 
amendments to the Annexes of this Directive. 

(24)  Member States should lay down rules on penalties applicable to infringements of the 
national  provisions  adopted  pursuant  to  this  Directive  and  ensure  that  they  are 
implemented. The penalties should be effective, proportionate and dissuasive. 

(25)  Since  the  objectives  of  the  Directive,  namely  to  ensure  a  high  level  of  protection  of 
human health and the environment, cannot be sufficiently achieved by Member States 
and can, therefore, be better achieved at Union level, the Union may adopt measures in 
accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In 
accordance  with  the  principle  of  proportionality,  as  set  out  in  that  Article,  this 
Directive does not go beyond what is necessary in order to achieve those objectives, 

HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

Subject matter 

This Directive lays down rules for the prevention of major accidents which involve dangerous 
substances,  and  the  limitation  of  their  consequences  for  human  health  and  the  environment, 

EN 

18 

   EN 

with  a  view  to  ensuring  high  levels  of  protection  throughout  the  Union  in  a  consistent  and 
effective manner. 

Article 2  

Scope 

1. 

2. 

This Directive shall apply to establishments where dangerous substances are present 
in quantities equal to or in excess of the quantities listed in Parts 1 and 2 of Annex I.  

This Directive shall not apply to any of the following: 

(a)  military establishments, installations or storage facilities; 

(b)  hazards created by ionizing radiation; 

(c) 

(d) 

(e) 

the  transport  of  dangerous  substances  and  intermediate  temporary  storage  by 
road, rail, internal waterways, sea or air, outside the establishments covered by 
this  Directive,  including  loading  and  unloading  and  transport  to  and  from 
another means of transport at docks, wharves or marshalling yards; 

the transport of dangerous substances in pipelines, including pumping stations, 
outside establishments covered by this Directive; 

the exploitation (exploration, extraction and processing) of minerals in mines, 
quarries,  or  by  means  of  boreholes,  with  the  exception  of  underground  gas 
storage  in  natural  strata  and  disused  mines  and  of  chemical  and  thermal 
processing  operations  and  storage  related  to  those  operations  which  involve 
dangerous substances, as defined in Annex I; 

(f) 

the offshore exploration and exploitation of minerals, including hydrocarbons; 

(g)  waste  land-fill  sites,  including  underground  waste  storage,  with  the  exception 
of  operational  tailings  disposal  facilities,  including  tailing  ponds  or  dams, 
containing dangerous substances as defined in Annex I, in particular when used 
in connection with the chemical and thermal processing of minerals; 

(h) 

substances listed in Part 3 of Annex I. 

Article 3 

Definitions 

For the purposes of this Directive the following definitions shall apply: 

1. 

‘establishment’  means  the  whole  location  under  the  control  of  an  operator  where 
dangerous substances falling within the scope of this Directive are present in one or 
more installations, including common or related infrastructures or activities; 

EN 

19 

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2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

12. 

'lower-tier  establishment’  means  an  establishment  where  dangerous  substances  are 
present in quantities equal to or in excess of the quantities listed in column 2 of Part 
1 of Annex I and column 2 of Part 2 of Annex I, , but less than the quantities listed in 
column 3 of Part 1 of Annex I, and column 3 of Part 2 of Annex I; 

‘upper-tier  establishment’  means  an  establishment  where  dangerous  substances  are 
present in quantities equal to or in excess of the quantities listed in column 3 of Part 
1 of Annex I, and column 3 of Part 2 of Annex I; 

'new  establishment'  means  an  establishment  that  is  newly  constructed  or  has  yet  to 
enter into operation; 

'existing establishment' means an establishment that fell within the scope of Directive 
96/82/EC; 

'subsequent  establishment'  means  an  establishment  that  was  operating  prior  to  the 
entry  into  force  of  this  Directive  but  was  not  previously  covered  by  Directive 
96/82/EC and subsequently falls within the scope of this Directive; 

‘installation’  means  a  technical  unit  within  an  establishment  in  which  dangerous 
substances  are  produced,  used,  handled  or  stored,  including  underground,  and 
includes  all  the  equipment,  structures,  pipework,  machinery,  tools,  private  railway 
sidings,  docks,  unloading  quays  serving  the  installation,  jetties,  warehouses  or 
similar  structures,  floating  or  otherwise,  necessary  for  the  operation  of  the 
installation; 

‘operator’  means  any  natural  or  legal  person  who  operates  or  controls  an 
establishment or installation or, where this is provided for by national legislation, to 
whom decisive economic power over the technical functioning of the establishment 
or installation has been delegated; 

‘dangerous  substance’  means  a  substance  or  mixture  listed  in  Part  1  or  Part  2  of 
Annex 1 and present as a raw material, product, by-product, residue or intermediate, 
including those substances which it is reasonable to suppose may be generated in the 
event of accident; 

'mixture' means a mixture or solution composed of two or more substances; 

‘presence  of  dangerous  substances’  means  the  actual  or  anticipated  presence  of 
dangerous substances in the establishment, or the presence of dangerous substances 
which it is believed may be generated during loss of control of an industrial chemical 
process, in quantities equal to or in excess of the thresholds set out in Parts 1 and 2 of 
Annex I. 

‘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  human 
health,  property  or  the  environment,  immediate  or  delayed,  inside  or  outside  the 
establishment, and involving one or more dangerous substances; 

13. 

‘hazard’ means the intrinsic property of a dangerous substance or physical situation, 
with a potential for creating damage to human health or the environment; 

EN 

20 

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14. 

15. 

16. 

17. 

18. 

1. 

2. 

3. 

‘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; 

'the  public'  means  one  or  more  natural  or  legal  persons  and,  in  accordance  with 
national law or practice, their associations, organisations or groups; 

'the public concerned' means the public affected or likely to be affected, or having an 
interest  in  the  taking  a  decision  on  any  of  the  matters  covered  by  Article  14(1), 
including  non-governmental  organizations  promoting  environmental  protection  and 
meeting any applicable requirements under national law ; 

'inspection'  means  all  actions,  including  site  visits,  checks  of  internal  measures, 
systems  and  reports  and  follow-up  documents,  and  any  necessary  follow-up, 
undertaken  by  or  on  behalf  of  the  competent  authority  to  check  and  promote 
compliance of establishments with the requirements of this Directive. 

Article 4  

Derogation and safeguard clauses  

Where it is demonstrated, on the basis of the criteria referred to in paragraph 4 of this 
Article, that particular substances covered by Parts 1 or 2 of Annex I are incapable of 
creating a major accident hazard, in particular due to their physical form, properties, 
classification,  concentration  or  generic  packaging,  the  Commission  may  list  those 
substances in Part 3 of Annex I by delegated acts in accordance with Article 24.  

Where a Member State considers that a dangerous substance listed in Parts 1 or 2 of 
Annex  I  does not present a major accident hazard and may qualify for inclusion in 
Part 3 of Annex I in accordance with paragraph 1 of this Article, it shall notify the 
Commission. 

The  Commission  shall  inform  the  forum  referred  to  in  Article  17(2)  of  such 
notifications. 

Where it is demonstrated to the satisfaction of a competent authority, on the basis of 
the  criteria  referred  to  in  paragraph  4  of  this  Article,  that  particular  substances 
present at an individual establishment or any part thereof and listed in Parts 1 or 2 of 
Annex  I  are  incapable  of  creating  a  major  accident  hazard,  due  to  the  specific 
conditions  pertaining  in  the  establishment  such  as  the  nature  of  the  packaging  and 
containment  of  the  substance  or  the  location  and  quantities  involved,  the  Member 
State of the competent authority may decide not to apply the requirements set out in 
Articles 7 to 19 of this Directive to the establishment concerned.  

In the cases referred to in  the first subparagraph the Member State  concerned shall 
provide  to  the  Commission  a  list  of  the  establishments  concerned,  including  the 
inventory  of  dangerous  substances  concerned.  The  Member  State  concerned  shall 
give reasons for the exclusion.  

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4. 

5. 

1. 

2. 

The  Commission  shall  forward  annually  the  lists  referred  to  in  the  second 
subparagraph  of  this  paragraph  to  the  forum  referred  to  in  Article  17(2)  for 
information. 

By  30  June  2013,  the  Commission  shall  adopt  delegated  acts  in  accordance  with 
Article 24, to establish criteria to be used for the purposes of paragraphs 1 and 3 of 
this Article respectively, and to amend Annex VII accordingly. 

Where a Member State considers that a dangerous substance not listed in Parts 1 or 2 
of Annex I, presents a major-accident hazard, it may take appropriate measures and 
shall notify the Commission.  

The Commission shall inform the forum referred to in Article 17(2) of notifications 
made pursuant to the first subparagraph of this paragraph.  

Where  appropriate,  the  Commission  may  list  the  substances  referred  to  in  the  first 
subparagraph  of  this  paragraph  in  Part  1  or  Part  2  of  Annex  I  by  delegated  acts  in 
accordance with Article 24. 

Article 5  

General obligations of the operator  

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

Member  States  shall  ensure  that  the  operator  is  required  to  prove  to  the  competent 
authority referred to in Article 17 (hereinafter ‘competent authority’), at any time, in 
particular for the purposes of the inspections and controls referred to in Article 19, 
that the operator has taken all the measures necessary as specified in this Directive. 

Article 6 

Notification 

1. 

Member  States  shall  require  the  operator  to  send  the  competent  authority  a 
notification containing the following details: 

(a) 

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

(b) 

the registered place of business of the operator, with the full address; 

(c) 

(d) 

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

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

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22 

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(e) 

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

(f) 

the activity or proposed activity of the installation or storage facility; 

(g) 

the  immediate  environment  of  the  establishment,  elements  liable  to  cause  a 
major  accident  or  to  aggravate  the  consequences  thereof, including  details  of 
neighbouring  establishments,  whether  or  not  those  are  covered  by  this 
Directive, as well as other sites, areas and developments that could increase the 
risk or consequences of a major accident and of domino effects. 

2. 

The notification shall be sent to the competent authority within the following time-
limits: 

3. 

4. 

(a) 

(b) 

(c) 

for  new  establishments,  a  reasonable  period  of  time  prior  to  the  start  of 
construction or operation, 

for  existing  establishments,  one  year  from  the  date  laid  down  in  the  second 
subparagraph of Article 28(1), 

for  subsequent  establishments,  one  year  from  the  date  on  which  this  Directive 
applies to the establishment concerned. 

Paragraphs  1  and  2  of  this  Article  shall  not  apply  to  existing  establishments  if  the 
operator  has  already  sent  a  notification  to  the  competent  authority  under  the 
requirements  of  national  law  at  the  date  laid  down  in  the  second  subparagraph  of 
Article  28(1),  and  the  information  contained  therein  complies  with  paragraph  1  of 
this Article and remains unchanged. 

The  operator  shall  immediately  inform  the  competent  authority  of  the  following 
events: 

(a) 

any  significant  increase  in  the  quantity  or  significant  change  in  the  nature  or 
physical  form  of  the  dangerous  substance  present,  as  indicated  in  the 
notification provided by the operator pursuant to paragraph 1, or any change in 
the processes employing it,  

(b)  modification  of  an  establishment  or  an  installation  which  could  have 

significant repercussions on major accident hazards,  

(c) 

permanent closure of the installation. 

5. 

Without  prejudice  to  paragraph  4,  the  operator  shall  periodically  review  and  where 
necessary  update  the  notification,  at  least  every  five  years.  The  operator  shall  send 
the updated notification to the competent authority without delay. 

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Article 7  

Major-accident prevention policy 

1. 

Member  States  shall  require  the  operator  to  draw  up  a  document  setting  out  the 
major-accident  prevention  policy  (hereinafter:  "MAPP")  and  to  ensure  that  it  is 
properly  implemented.  The  MAPP  shall  be  established  in  writing.  It  shall  be 
designed  to  guarantee  a  high  level  of  protection  for  human  health  and  the 
environment. It shall be proportionate to the major-accident hazards. It shall include 
the  operator's  overall  aims  and  principles  of  action,  the  role  and  responsibility  of 
management  and  shall  address  safety  culture  with  respect  to  the  control  of  major-
accident hazards. 

2. 

The MAPP shall be sent to the competent authority within the following time-limits: 

(a) 

(b) 

(c) 

for  new  establishments,  a  reasonable  period  of  time  prior  to  the  start  of 
construction or operation; 

for  existing  establishments,  one  year  from  the  date  laid  down  in  the  second 
subparagraph of Article 28(1) 

for  subsequent  establishments,  one  year  from  the  date  on  which  this  Directive 
applies to the establishment concerned. 

Paragraphs  1  and  2  of  this  Article  shall  not  apply  to  existing  establishments  if  the 
operator  has  already  established  the  MAPP  in  writing  and  sent  it  to  the  competent 
authority under the requirements of national law at the date laid down in the second 
subparagraph of Article 28(1), and the information contained therein complies with 
paragraph 1 and remains unchanged. 

The  operator  shall  periodically  review  and  where  necessary  update  the  MAPP,  at 
least  every  five  years.  The  updated  MAPP  shall  be  sent  to  the  competent  authority 
without delay. 

Article 8  

Domino effect 

Member  States  shall  ensure  that  the  competent  authority,  using  the  information 
received  from  the  operators  in  compliance  with  Articles  6  and  9  or  through 
lower-tier  and  upper-tier 
inspections  pursuant 
establishments  or  groups  of  establishments  where  the likelihood  and  the  possibility 
or  consequences  of  a  major  accident  may  be  increased  because  of  the  location  and 
the proximity of such establishments, and their inventories of dangerous substances. 

to  Article  19, 

identifies  all 

3. 

4. 

1. 

2. 

Member  States  shall  ensure  that  operators  of  the  establishments  identified  in 
accordance with paragraph 1: 

a) 

exchange  suitable  information  in  an  appropriate  manner  to  enable  those 
establishments to take account of the nature and extent of the overall hazard of 

EN 

24 

   EN 

a  major  accident  in  their  MAPP,  safety  management  systems,  safety  reports 
and internal emergency plans; 

b) 

cooperate  in  informing  the  public  and  neighbouring  establishments  that  fall 
outside  the  scope  of  this  Directive,  and  in  supplying  information  to  the 
authority responsible for the preparation of external emergency plans. 

Article 9 

Safety report 

1. 

Member States shall require the operator of an upper-tier establishment to produce a 
safety report for the purposes of: 

(a) 

demonstrating that a MAPP and a safety management system for implementing 
it have been put into effect in accordance with the information set out in Annex 
III;  

(b)  demonstrating 

that  major-accident  hazards  and  possible  major-accident 
scenarios have been identified and that the necessary measures have been taken 
to prevent such accidents and to limit their consequences for human health and 
the environment; 

(c) 

demonstrating that adequate safety and reliability have been taken into account 
in  the  design,  construction,  operation  and  maintenance  of  any  installation, 
storage  facility,  equipment  and  infrastructure  connected  with  its  operation 
which are linked to major-accident hazards inside the establishment; 

(d)  demonstrating  that  internal  emergency  plans  have  been  drawn  up  and 

supplying information to enable the external emergency plan to be drawn up;  

(e) 

providing  sufficient  information  to  the  competent  authorities  to  enable 
decisions  to  be  made  regarding  the  siting  of  new  activities  or  developments 
around existing establishments. 

2. 

3. 

shall 

report 

safety 
contain 
in  Annex  II.  It  shall  name 

information 
The 
listed 
in 
involved 
the  drawing  up  of  the  report.  It  shall  also  contain  an  updated  inventory 
of the dangerous substances present in the establishment. 

at 
and 
the  relevant  organisations 

the  data 

least 

The safety report shall be sent to the competent authority within the following time-
limits: 

(a) 

(b) 

(c) 

for  new  establishments,  a  reasonable  period  of  time  prior  to  the  start  of 
construction or operation; 

for  existing  establishments,  one  year  from  the  date  laid  down  in  the  second 
subparagraph of Article 28(1) 

for  subsequent  establishments,  two years from the date on which this Directive 
applies to the establishment concerned.. 

EN 

25 

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4. 

5. 

6. 

7. 

Paragraphs  1,  2  and  3  of  this  Article  shall  not  apply  to  existing  establishments  if  the 
operator  has  already  sent  the  safety  report  to  the  competent  authority  under  the 
requirements of national law at the date laid down in Article 28(1), and the information 
contained  therein  complies  with  paragraphs  1  and  2  of  this  Article  and  remains 
unchanged. 

The operator shall periodically review and where necessary update the safety report 
at least every five years. 

The operator shall also review and where necessary update the safety report at any 
other time at the initiative of the operator or the request of the competent authority, 
where  justified  by  new  facts  or  by  new  technological  knowledge  about  safety 
matters, including knowledge arising from analysis of accidents or, as far as possible, 
'near  misses',  and  by  developments  in  knowledge  concerning  the  assessment  of 
hazards. 

The updated safety report shall be sent to the competent authority without delay. 

Before the operator commences construction or operation, or in the cases referred to in 
points (b) and (c) of paragraph 3 and in paragraph 5, the competent authority shall within 
a reasonable period of receipt of the report: 

(a) 

communicate  the  conclusions  of  its  examination  of  the  safety  report  to  the 
operator,  

(b)  prohibit  the  bringing  into  use,  or  the  continued  use,  of  the  establishment 

concerned, in accordance with Article 18. 

Member  States  may  require  lower-tier  establishments  to  implement  the  MAPP  by 
means of a safety management system proportionate to the major-accident hazards, 
and to the complexity of the organization or activities of the establishment.  

Article 10 

Modification of an installation, an establishment or a storage facility 

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

(a) 

(b) 

reviews and where necessary revises the MAPP; 

reviews,  and  where  necessary  revises,  the  safety  report  and  the  safety  management 
systems and procedures referred to in Article 9 and informs the competent authority 
of the details of that revision in advance of that modification. 

EN 

26 

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Article 11 

Emergency plans 

1. 

Member States shall ensure that, for all upper-tier establishments: 

(a) 

(b) 

(c) 

the operator draws up an internal emergency plan for the measures to be taken 
inside the establishment;  

the operator supplies the necessary information to the competent authorities, to 
enable the latter to draw up external emergency plans; 

the  authorities  designated  for  that  purpose  by  the  Member  State  draw  up  an 
external emergency plan for the measures to be taken outside the establishment 
within one year following receipt of the information from the operator pursuant 
to point (b). 

2. 

Operators shall comply with the obligations set out in points (a) and (b) of paragraph 
1within the following time limits: 

(a) 

for new establishments, prior to the start of operation; 

(b) 

for  existing  establishments,  one  year  from  the  date  laid  down  in  the  second 
subparagraph  of  Article  28(1)  unless  the  internal  emergency  plan  drawn  up 
under  the  requirements  of  national  law  at  that  date,  and  the  information 
contained therein, complies with this Article and remains unchanged. 

(c) 

for subsequent establishments, one year from the date on which this Directive 
applies to the establishment concerned.  

3. 

The emergency plans shall be established with the following objectives: 

(a) 

(b) 

(c) 

containing and controlling incidents so as to minimize the effects, and to limit 
damage to human health, the environment and property, 

implementing  the  measures  necessary  to  protect  human  health  and  the  envir-
onment from the effects of major accidents, 

communicating the necessary information to the public and to the services or 
authorities concerned in the area, 

(d)  providing  for  the  restoration  and  clean-up  of  the  environment  following  a 

major accident. 

Emergency plans shall contain the information set out in Annex IV. 

4. 

Without  prejudice  to  the  obligations  of  the  competent  authorities,  Member  States 
shall  ensure  that  the  internal  emergency  plans  provided  for  in  this  Directive  are 
drawn  up  in  consultation  with  the  personnel  working  inside  the  establishment, 
including  long-term  relevant  subcontracted  personnel,  and  that  the  public  is 
consulted  on  external  emergency  plans  when  they  are  established  or  updated. 

EN 

27 

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5. 

6. 

7. 

1. 

Member  States  shall  ensure  that  consultation  with  the  public  is  in  accordance  with 
Article 14.  

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 respectively at suitable intervals of 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. 

With regard to external emergency plans, Member States shall take into account the 
need  to  facilitate  enhanced  cooperation  in  civil  protection  assistance  in  major 
emergencies. 

Member States shall ensure that emergency plans are put into effect without delay by 
the operator and, if necessary, by the competent authority designated for this purpose 
when  a  major  accident  occurs,  or  when  an  uncontrolled  event  occurs  which  by  its 
nature could reasonably be expected to lead to a major accident. 

The  competent  authority  may  decide,  in  view  of  the  information  contained  in  the 
safety  report,  that  the  requirement  to  produce  an  external  emergency  plan  under 
paragraph 1 shall not apply.  

The competent authority shall give reasons for its decision. 

Article 12 

Land-use planning 

Member  States  shall  ensure  that  the  objectives  of  preventing  major  accidents  and 
limiting  the  consequences  of  such  accidents  for  human  health  and  the  environment 
are taken into account in their land-use policies or other relevant policies. They shall 
pursue those objectives through controls on: 

(a) 

the siting of new establishments; 

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

(c) 

new developments including transport links, locations frequented by the public 
and residential areas in the vicinity of existing establishments, where the siting 
or developments may increase the risk or consequences of a major accident. 

2. 

Member  States  shall  ensure  that  their  land-use  or  other  relevant  policies  and  the 
procedures  for  implementing  those  policies  take  account  of  the  need,  in  the  long 
term: 

(a) 

to  maintain  appropriate  safety  distances  between  establishments  covered  by 
this  Directive  and  residential  areas,  buildings  and  areas  of  public  use,  major 
transport routes as far as possible, and recreational areas; 

EN 

28 

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(b) 

(c) 

to  protect  areas  of  particular  natural  sensitivity  or  interest  in  the  vicinity  of 
establishments covered by this Directive, through appropriate safety distances 
or other appropriate measures where necessary;  

in the case of existing establishments, to take additional technical measures in 
accordance with Article 5 so as not to increase the risks to human health and 
the environment. 

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

Member States shall ensure that operators of lower-tier establishments provide, at the 
request  of  the  competent  authority,  sufficient  information  on  the  risks  arising  from 
the establishment necessary for land-use planning purposes.  

The  requirements  of  paragraphs  1,  2  and  3  shall  apply  without  prejudice  to  the 
provisions  of  Council  Directive  85/337/EEC12  and  Directive  2001/42/EC  of  the 
European Parliament and of the Council13. Member States shall where possible and 
appropriate  provide  for  coordinated  or  joint  procedures  in  order  to  fulfil  the 
requirements  of  this  Article  and  the  requirements  of  those  Directives,  inter  alia,  to 
avoid duplication of assessment or consultations.  

3. 

4. 

Article 13 

Information to the public 

1. 

Member  States  shall  ensure  that  the  information  referred  to  in  Annex  V  is 
permanently  available  to  the  public,  including  in  an  electronic  format.  The 
information shall be reviewed and where necessary updated at least once a year.  

2. 

For upper-tier establishments, Member States shall also ensure that:  

a) 

b) 

all persons liable to be affected by a major accident receive regularly and in the 
most appropriate form, without their having to request it, information on safety 
measures and requisite behaviour in the event of an accident;  

the safety report is made available to the public upon request subject to Article 
21(3);  where  Article  21(3)  applies,  an  amended  report  in  the  form  of  a  non-
technical summary, which shall include at least general information on major-
accident hazards, potential effects and the requisite behaviour in the event of an 
accident, shall be made available; 

12 
13 

OJ L 175, 5.7.1985, p.40 
OJ L 197, 21.7.2001, p.30 

EN 

29 

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c) 

the  inventory  of  dangerous  substances  is  made  available  to  the  public 
concerned upon request subject to Article 21(3). 

The information to be supplied under point (a) of this paragraph shall include at least 
the information referred to in Annex V. That information shall likewise be supplied 
to  all  establishments  serving  the  public,  including  schools  and  hospitals,  and  to  all 
neighbouring  establishments  in  the  case  of  establishments  covered  by  Article  8. 
Member States shall ensure that the information is supplied and that it is periodically 
reviewed and updated at least every five years.  

Requests for access to the information referred to in paragraph 2(a), (b) and (c) shall be 
handled  in  accordance  with  Articles  3  and  5  of  Directive  2003/4/EC  of  the  European 
Parliament and of the Council14. 

Member  States  shall,  with  respect  to  the  possibility  of  a  major  accident  with 
transboundary  effects  originating  in  an  establishment  under  Article  9,  provide 
sufficient  information  to the potentially  affected  Member  States  so  that  all  relevant 
provisions  contained  in  Articles  11,  12  and  this  Article  can  be  applied,  where 
applicable, by the potentially affected Member States. 

Where  the  Member  State  concerned  has  decided  that  an  establishment  close  to  the 
territory  of  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. 

3. 

4. 

5. 

6. 

This Article shall apply subject to the provisions of Article 21.  

Article 14 

Public consultation and participation in decision-making 

1. 

Member States shall ensure that the public is able to give its opinion on the following 
matters: 

(a) 

planning for new establishments pursuant to Article 12; 

(b)  modifications  to  existing  establishments  under  Article  10,  where  such 
modifications  are  subject  to  obligations  provided  for  in  this  Directive  as  to 
planning; 

(c) 

new  developments  around  existing  establishments  where  the  siting  or 
developments  may  increase  the  risk  or  consequences  of  a  major  accident 
pursuant to Article 12; 

(d) 

external emergency plans pursuant to Article 11(1)(c) 

14 

OJ L 41, 14.2.2003, p. 26. 

EN 

30 

   EN 

                                                 
2. 

The public shall be informed by public notices or other appropriate means, including 
electronic media where available, of the following matters early in the procedure for 
the taking of a decision or, at the latest, as soon as the information can reasonably be 
provided: 

(a) 

the matters set out in paragraph 1; 

(b)  where  applicable,  the  fact  that  a  decision  is  subject  to  a  national  or 
transboundary  environmental  impact  assessment  or  to  consultations  between 
Member States in accordance with Article 13(4); 

(c) 

details of the competent authority responsible for taking the decision, that from 
which  relevant  information  can  be  obtained,  that  to  which  comments  or 
questions  can  be  submitted,  and  details  of  the  time  schedule  for  transmitting 
comments or questions; 

(d) 

the nature of possible decisions or, where there is one, the draft decision; 

(e) 

an  indication of the times  and places where,  or  means  by  which,  the  relevant 
information will be made available; 

(g)  details  of  the  arrangements  for  public  participation  and  consultation  made 

pursuant to paragraph 5. 

3. 

Member  States  shall  ensure  that,  within  appropriate  time-frames,  the  following  is 
made available to the public concerned: 

(a) 

(b) 

in  accordance with national legislation,  the main reports  and  advice  issued to 
the  competent  authority  or  authorities  at  the  time  when  the  public  concerned 
was informed in accordance with paragraph 2; 

in  accordance  with  the  provisions  of  Directive  2003/4/EC  information  other 
than  that  referred  to  in  paragraph  2  which  is  relevant  for  the  decision  in 
question  and  which  only  becomes  available  after  the  public  concerned  was 
informed in accordance with paragraph 2. 

Member States shall ensure that the public concerned is entitled to express comments and 
opinions to the competent authority before a decision is taken and that the results of the 
consultations held pursuant to paragraph 1 are duly taken into account in the taking of a 
decision. 

The detailed arrangements for informing the public and consulting the public concerned 
shall be determined by the Member States.  

Reasonable  time-frames  for  the  different  phases  shall  be  provided,  allowing 
sufficient time for informing the public and for the public concerned to prepare and 
participate effectively in environmental decision-making subject to the provisions of 
this Article. 

4. 

5. 

6. 

Member  States  shall  ensure  that  when  the  relevant  decisions  are  taken,  the  competent 
authority shall make available to the public: 

EN 

31 

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(a)  the  content  of  the  decision  and  the  reasons  on  which  it  is  based,  including  any 

subsequent updates; 

(b)  the  results  of  the  consultations  held  before  the  decision  was  taken  and  an 

explanation of how they were taken into account in that decision. 

Article 15 

Information to be supplied by the operator following a major accident 

1. 

Member States shall 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: 

(i) 

the circumstances of the accident; 

(ii) 

the dangerous substances involved; 

(iii) 

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

(iv) 

the emergency measures taken; 

(c) 

to inform them of the steps envisaged: 

(i) 

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

(ii) 

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. 

Member States shall require the competent authority: 

(a) 

(b) 

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

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. 

EN 

32 

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Article 16 

Information to be supplied by the Member States following a major accident 

1. 

For the purpose of prevention and mitigation of major accidents, Member States shall 
inform the Commission as soon as practicable of major accidents meeting the criteria 
of  Annex  VI  which  have  occurred  within  their  territory.  They  shall  provide  it  with 
the following details: 

(a) 

(b) 

(c) 

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

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

a  brief  description  of  the  circumstances  of  the  accident,  including  the 
dangerous substances involved, and the immediate effects on human health and 
the environment; 

(d) 

a  brief  description  of  the  emergency  measures  taken  and  of  the  immediate 
precautions necessary to prevent recurrence. 

Member  States  shall  inform  the  Commission  of  the  result  of  their  analysis  and 
recommendations, as soon as practicable and at the latest within one year of the date 
of the accident, using the database referred to in Article 20(5).  

Reporting of the information referred to in the first subparagraph by Member States 
may  be  delayed  only  to  allow  for  the  completion  of  legal  proceedings  where  such 
reporting may affect those proceedings. 

The Commission shall establish a report form in close cooperation with the Member 
States.  Member  States  shall  use  that  report  form  when  providing  the  information 
referred to in paragraph 1 and paragraph 2.  

Member  States  shall  inform  the  Commission  of  the  name  and  address  of  any  body 
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 17 

Competent authority 

Without  prejudice  to  the  operator's  responsibilities,  Member  States  shall  set  up  or 
appoint the competent authority or authorities responsible for carrying out the duties 
laid down in this Directive and, if necessary, bodies to assist the competent authority 
or  authorities  at  technical  level. Member  States  which  set  up  or  appoint  more  than 
one competent authority shall appoint one competent authority to take responsibility 
for ensuring that the procedures for carrying out their duties are coordinated. 

2. 

3. 

4. 

1. 

EN 

33 

   EN 

2. 

3. 

1. 

2. 

1. 

2. 

The Commission shall regularly convene a forum composed of representatives of the 
competent  authorities  of  the  Member  States.  The  competent  authorities  and  the 
Commission  shall  cooperate  in  activities  in  support  of  implementation  of  this 
Directive. 

Member  States  shall  ensure  that  competent  authorities  accept  equivalent  information 
submitted by operators in accordance with other Union legislation, which fulfils any of 
the requirements of this Directive, for the purposes  of this Directive.  In  such cases  the 
competent  authority  shall  ensure  that  the  requirements  of  this  Directive  are  complied 
with. 

Article 18 

Prohibition of use 

Member  States  shall  prohibit  the  use  or  bringing  into  use  of  any  establishment, 
installation or storage facility, or any part  thereof where  the  measures  taken  by  the 
operator for the prevention and mitigation of major accidents are seriously deficient. 

Member  States  may  prohibit  the  use  or  bringing  into  use  of  any  establishment, 
installation  or  storage  facility,  or  any  part  thereof  if  the  operator  has  not  submitted 
the  notification,  reports  or  other  information  required  by  this  Directive  within  the 
specified period. 

Member States shall ensure that operators may appeal against a prohibition order by 
a  competent  authority  under  paragraph  1  to  an  appropriate  body  determined  by 
national law and procedures. 

Article 19 

Inspections 

Member  States  shall  ensure  that  the  competent  authorities  organise  a  system  of 
inspections.  

Inspections  shall  be  appropriate  to  the  type  of  establishment  concerned.  They  shall 
not  be  dependent  upon  receipt  of  the  safety  report  or  any  other  report  submitted. 
They  shall  be  sufficient  for  a  planned  and  systematic  examination  of  the  systems 
being  employed  at  the  establishment,  whether  of  a  technical,  organisational  or 
managerial nature, so as to ensure in particular that: 

(a) 

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

(b) 

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

EN 

34 

   EN 

(c) 

the  data  and  information  contained  in  the  safety  report,  or  any  other  report 
submitted, adequately reflects the conditions in the establishment; 

(d) 

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

3. 

Member States shall ensure that all establishments are covered by an inspection plan 
at national, regional or local level and shall ensure that this plan is regularly reviewed 
and, where appropriate, updated.  

Each inspection plan shall include the following: 

(a) 

a general assessment of relevant safety issues; 

(b) 

the geographical area covered by the inspection plan; 

(c) 

a list of the establishments and installations covered by the plan; 

(d) 

(e) 

(f) 

a  list  of  groups  of  establishments  with  possible  domino-effects  pursuant  to 
Article 8, taking into account neighbouring establishments outside the scope of 
this Directive; 

a list of establishments where particular external risks or hazard sources could 
increase the risk or consequences of a major accident; 

procedures  for  routine  inspections,  including  the  programmes  for  such 
inspections pursuant to paragraph 4; 

(g)  procedures for non-routine inspections pursuant to paragraph 6; 

(h)  provisions on the co-operation between different inspection authorities. 

4. 

Based  on  the  inspections  plans  referred  to  in  paragraph  3,  the  competent  authority 
shall  regularly  draw  up  programmes  for  routine  inspections  for  all  establishments 
including the frequency of site visits for different types of establishments.  

The  period  between  two  site  visits  shall  be  based  on  a  systematic  appraisal  of  the 
major-accident  hazards  of  the  establishments  concerned  and  shall  not  exceed  one 
year for upper-tier establishments and three years for lower-tier establishments. If an 
inspection has identified an important case of non-compliance with this Directive, an 
additional site visit shall be carried out within six months. 

5. 

The  systematic  appraisal  of  the  hazards  shall  be  based  on  at  least  the  following 
criteria: 

(a) 

the  potential  and  actual  impacts  of  the  establishments  concerned  on  human 
health and the environment taking into account the major-accident hazards, the 
sensitivity of the local environment and the risk of accidents; 

(b) 

the record of compliance with the requirements of this Directive; 

EN 

35 

   EN 

(c) 

participation  of  the  operator  in  the  Union  eco-management  and  audit  scheme 
(EMAS),  pursuant  to  Regulation  (EC)  No  1221/2009  of  the  European 
Parliament and of the Council15. 

Where  appropriate,  relevant  findings  of  inspections  under  other  Union  legislation 
shall also be taken into account. 

Non-routine inspections shall be carried out to investigate serious complaints, serious 
accidents and near-misses, incidents and occurrences of non-compliance as soon as 
possible. 

Within two months after each site visit, the competent authority shall communicate 
the  conclusions  of  the  visit  and  all  the  necessary  actions  identified  to  the  operator. 
The  competent  authority  shall  ensure  that  the  operator  takes  all  these  necessary 
actions within a reasonable period after receipt of the communication. 

Inspections  shall  whenever  possible  be  coordinated  with  inspections  under  other 
Union legislation and combined, where appropriate. 

Member  States  shall  ensure  that  sufficient  staff  are  available  with  the  skills  and 
qualifications  needed  to  carry  out  inspections  effectively.  Member  States  shall 
encourage the competent authorities to provide mechanisms and tools for exchanging 
experience  and  consolidating  knowledge,  and  to  participate  in  such  mechanisms  at 
Union level where appropriate. 

Member States shall ensure that operators provide the competent authorities with all 
necessary  assistance  to  enable  those  authorities  to  carry  out  any  site  visits  and  to 
gather any information necessary for the performance of their duties for the purposes 
of this Directive, in particular to allow the authority to fully assess the possibility of a 
major  accident  and  to  determine  the  scope  of  possible  increased  probability  or 
aggravation  of  major  accidents,  to  prepare  an  external  emergency  plan  and  to  take 
into  account  substances  which,  due  to  their  physical  form,  particular  conditions  or 
location, may require additional consideration. 

Article 20 

Information system and exchanges 

Member  States  and  the  Commission  shall  exchange  information  on  the  experience 
acquired with regard to the prevention of major accidents and the limitation of their 
consequences.  This  information  shall  concern,  in  particular,  the  functioning  of  the 
measures provided for in this Directive. 

Member States shall ensure that the information referred to in Annex V, or a summary 
thereof in the case of the information referred to in part 2 of Annex V, is made available 
in an electronic format to the Commission, and updated on a continuous basis. 

6. 

7. 

8. 

9. 

10. 

1. 

2. 

15 

OJ L 342, 22.12.2009, p.1 

EN 

36 

   EN 

                                                 
3. 

The Commission shall set up and keep up to date an electronic database containing the 
information supplied by the Member States pursuant to paragraph 2.  

4. 

5. 

The  Commission  shall,  in  close  cooperation  with  the  Member  States,  establish 
automated  data  exchange  systems  and  a  reporting  format  to  be  used  for 
communicating the information referred to in paragraph 2 by 1 January 2015. 

Member  States  shall  provide  the  Commission  with  a  three-yearly  report  on  the 
implementation of this Directive. They shall also provide a summary of the information 
referred  to  in  paragraph  2  in  electronic  format  or  identify  the  databases  where  that 
information can be accessed.  

The Commission shall make publicly available an overall summary of those reports 
every three years in electronic format. 

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

a) 

b) 

c) 

d) 

the rapid dissemination of the information supplied by Member States pursuant 
to Article 16(1) and (2) among all competent authorities; 

distribution  to  competent  authorities  of  an  analysis  of  the  causes  of  major 
accidents and the lessons learned from them; 

supply of information to competent authorities on preventive measures; 

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

6. 

The database shall contain, at least: 

a) 

the  information  supplied  by  Member  States  in  accordance  with  Article  16(1) 
and (2); 

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. 

7. 

The Commission shall make the databases referred to in paragraphs 3 and 5 available 
to the public.  

Article 21 

Confidentiality 

1. 

Member  States  shall  ensure,  in  the  interests  of  transparency,  that  the  competent 
authorities  are  required  to  make  information  received  pursuant  to  this  Directive 
available to any natural or legal person who so requests. 

EN 

37 

   EN 

2. 

3. 

1. 

2. 

3. 

Requests for information obtained by the competent authorities under this Directive may 
be refused where the conditions down in Article 4(2) of Directive 2003/4/EC are fulfilled.  

Access to the complete information referred to in Article 13(2)(b) and (c) obtained 
by  the  competent  authorities  may  be  refused  if  the  operator  has  requested  not  to 
disclose certain parts of the safety report or the inventory of dangerous substances for 
the  reasons  provided  for  in  points  (b),  (d),  (e)  or  (f)  of  Article  4(2)  of  Directive 
2003/4/EC.  

The competent authority  may  also decide for the same reasons that certain parts of 
the report or inventory shall not be disclosed. In such cases, and on approval of the 
competent authority, the operator shall supply to the authority, and make available to 
the public, an amended report or inventory excluding those parts. 

Article 22 

Access to justice 

Member States shall ensure that, members of the public concerned are able to seek a 
review in accordance with Article 6 of Directive 2003/4/EC of the acts or omissions 
of a competent authority in relation to any request for information pursuant to Article 
13  or  Article  21(1)  of  this  Directive.  Member States  shall ensure that,  in  accordance 
with the relevant national legal system, members of the public concerned have access to a 
review  procedure  before  a  court  of  law  or  another  independent  and  impartial  body 
established by law to challenge the substantive or procedural legality of decisions, acts or 
omissions relating to cases subject to Article 14 where: 

a) 

b) 

they have sufficient interest;  

they maintain the impairment of a right, where administrative procedural law of a 
Member State requires this as a precondition. 

Member States shall determine at what stage the decisions, acts or omissions may be 
challenged. 

What constitutes a sufficient interest and impairment of a right shall be determined 
by the Member States, consistently with the objective of giving the public concerned 
wide access to justice. To this end, the interest of any non-governmental organisation 
promoting  environmental  protection  and  meeting  any  requirements  under  national 
law shall be deemed sufficient for the purpose of paragraph 2(a). 

The organisations referred to in the first subparagraph shall also be deemed to have 
rights capable of being impaired for the purpose of paragraph 2(b). 

Paragraph  2  shall  not  exclude  the  possibility  of  a  preliminary  review  procedure 
before an administrative authority and shall not affect the requirement of exhaustion 
of administrative review procedures prior to recourse to judicial review procedures, 
where such a requirement exists under national law. 

EN 

38 

   EN 

4. 

The procedures provided for in paragraphs 1 and 2 shall be fair, equitable, timely and 
not prohibitively expensive. Injunctive relief shall be provided where appropriate. 

Member States shall ensure that practical information is made available to the public 
on access to those procedures. 

Article 23 

Amendment of Annexes 

Without prejudice to Article 4, in order to adapt Annexes I to VII to technical progress, the 
Commission shall adopt delegated acts in accordance with Article 24. 

Article 24 

Exercise of the delegation 

1. 

2. 

3. 

1. 

2. 

3. 

The  powers  to  adopt  the  delegated  acts  referred  to  in  Articles  4  and  23  shall  be 
conferred on the Commission for an indeterminate period of time. 

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council.  

The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  subject  to  the 
conditions laid down in Articles 25 and 26. 

Article 25 

Revocation of the delegation 

The delegation of powers referred to in Article 24 may be revoked at any time by the 
European Parliament or by the Council. 

The institution which has commenced an internal procedure for deciding whether to 
revoke the delegation of power shall endeavour to inform the other institution and the 
Commission within a  reasonable  time  before  the final  decision is  taken,  stating  the 
delegated  powers  which  could  be  subject  to  revocation  and  the  reasons  for  a 
revocation. 

The decision of revocation shall put an end to the delegation of the powers specified 
in that decision. It shall take effect immediately or at a later date specified therein. It 
shall  not  affect  the  validity  of  the  delegated  acts  already  in  force.  It  shall  be 
published in the Official Journal of the European Union. 

EN 

39 

   EN 

Article 26 

Objections to delegated acts 

1. 

2. 

3. 

The European Parliament and the Council may object to the delegated act within a 
period of two months from the date of notification. At the initiative of the European 
Parliament or the Council this period shall be extended by one month. 

If,  on  expiry  of  that  period,  neither  the  European  Parliament  nor  the  Council  has 
objected  to  the  delegated  act  it  shall  be  published  in  the  Official  Journal  of  the 
European Union and shall enter into force at the date stated therein.  

The  delegated  act  may  be  published  in  the Official Journal of the European Union 
and enter into force before the expiry of that period if the European parliament and 
the  Council  have  both  informed  the  Commission  of  their  intention  not  to  raise 
objections. 

If the European Parliament or the Council objects to a delegated act, it shall not enter 
into  force.  The  institution  which  objects  shall  state  the  reasons  for  objecting  to  the 
delegated act. 

Article 27 

Penalties 

Member  States  shall  determine  penalties  applicable  to  infringements  of  the  national 
provisions  adopted  pursuant  to  this  Directive.  The  penalties  thus  provided  for  shall  be 
effective,  proportionate  and  dissuasive.  Member  States  shall  notify  these  provisions  to  the 
Commission by 1 June 2015 at the latest and shall notify it without delay of any subsequent 
amendment affecting them. 

Article 28 

Transposition 

1. 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 
provisions  necessary  to  comply  with  this  Directive  by  31  May  2015  at  the  latest. 
They  shall  forthwith  communicate  to  the  Commission  the  text  of  those  provisions 
and a correlation table between those provisions and this Directive. 

They shall apply those measures from 1 June 2015. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

2. 

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

EN 

40 

   EN 

Article 29 

Repeal 

1. 

2. 

Directive 96/82/EC is repealed with effect from 1 June 2015. 

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

Article 30 

Entry into force 

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

Article 31 

Addressees 

This Directive is addressed to the Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

EN 

41 

   EN 

Annex I - List of dangerous substances 

List of Annexes 

Annex II - Minimum Data and information to be considered in the safety report specified in 
Article 9 

Annex  III  -  Information  referred  to  in  Article  9  on  the  management  system  and  the 
organisation of the establishment with a view to the prevention of major accidents 

Annex  IV  -  Data  and  information  to  be  included  in  the  emergency  plans  specified  under 
Article 11 

Annex V - Items of information to be communicated to the public as provided for in Article 
13(1) and (2)(a) 

Annex VI - Criteria for the notification of an accident to the Commission as provided for in 
Article 16(1) 

Annex VII - Criteria for derogations pursuant to Article 4 

Annex VIII - Correlation table 

EN 

42 

   EN 

ANNEX I 

List of dangerous substances 

PART 1  

Categories of substances and mixtures  

Annex I Part 1 covers all substances and mixtures falling under the hazard categories listed in 
Column 1: 

Column 1 

Column 2 

Column 3 

Categories of dangerous substances and mixtures 

Qualifying quantity (tonnes) 

of substances  
as referred to in 
Article 3(9)  
for the application of 

Lower-tier 
requirements 

Upper-tier 
requirements 

Section ‘H’ – HEALTH HAZARDS  

H1 ACUTE TOXIC Category 1, all exposure routes 

5 

20 

H2 ACUTE TOXIC  

- Category 2, all exposure routes 

50 

200 

- Category 3, dermal and inhalation exposure routes (see note 7) 

H3  STOT  SPECIFIC  TARGET  ORGAN  TOXICITY  – SINGLE 

EXPOSURE  

STOT Category 1 

Section ‘P’ - PHYSICAL HAZARDS 

P1a EXPLOSIVES (see note 8)  

- Unstable explosives or  

50 

200 

- Explosives, Division 1.1, 1.2, 1.3, 1.5 or 1.6, or 

10 

50 

-  Substances  or  mixtures  having  explosive  properties  according 
to method A.14 of Regulation (EC) No 440/2008 (see note 9) and 
do  not  belong  to  the  hazard  classes  Organic  peroxides  or  Self-
reactive substances and mixtures 

P1b EXPLOSIVES (see note 8) 

Explosives, Division 1.4 (see note 10) 

50 

200 

EN 

43 

   EN 

 
 
 
 
Column 1 

Column 2 

Column 3 

Categories of dangerous substances and mixtures 

P2 FLAMMABLE GASES 

Flammable gases, Category 1 or 2  

P3a FLAMMABLE AEROSOLS (see note 11.1) 

Qualifying quantity (tonnes) 

of substances  
as referred to in 
Article 3(9)  
for the application of 

Lower-tier 
requirements 

Upper-tier 
requirements 

10 

50 

“Extremely flammable” or “Flammable” aerosols, containing 
flammable gases Category 1 or 2 or flammable liquids Category 
1 

150 

500 

P3b FLAMMABLE AEROSOLS (see note 11.1) 

“Extremely flammable” or “Flammable” aerosols, not containing 
flammable gases Category 1 or 2 nor flammable liquids category 
1 (see note 11.2) 

5.000 

50.000 

P4 OXIDIZING GASES 

Oxidizing gases, Category 1 

P5a FLAMMABLE LIQUIDS 

- Flammable liquids, Category 1, or 

50 

200 

- Flammable liquids Category 2 or 3 maintained at a temperature 
above their boiling point, or 

10 

50 

-  Other  liquids  with  a  flash  point  ≤  60°C,  maintained  at  a 
temperature above their boiling point (see note 12) 

P5b FLAMMABLE LIQUIDS 

-  Flammable  liquids  Category  2  or 3  where  particular  processing 
conditions, such as high pressure or high temperature, may create 
major-accident hazards, or 

50 

200 

-  Other  liquids  with  a  flash  point  ≤  60°C  where  particular 
processing conditions, such as high pressure or high temperature, 
may create major-accident hazards (see note 12) 

EN 

44 

   EN 

Column 1 

Column 2 

Column 3 

Categories of dangerous substances and mixtures 

P5c FLAMMABLE LIQUIDS 

Flammable liquids, Categories 2 or 3 not covered by P5a and P5b 

 P6a  SELF-REACTIVE  SUBSTANCES  AND  MIXTURES  and 

ORGANIC PEROXIDES 

Self-reactive  substances  and  mixtures,  Type  A  or  B  or 
organic peroxides, Type A or B 

 P6b  SELF-REACTIVE  SUBSTANCES  AND  MIXTURES  and 

ORGANIC PEROXIDES 

Self-reactive substances and mixtures, Type C, D, E or F or  
organic peroxides, Type C, D, E, or F 

P7 PYROPHORIC LIQUIDS AND SOLIDS 

Pyrophoric liquids, Category 1 

Pyrophoric solids, Category 1 

P8 OXIDIZING LIQUIDS AND SOLIDS 

Oxidizing Liquids, Category 1, 2 or 3, or 

Oxidizing Solids, Category 1, 2 or 3 

Section ‘E’ – ENVIRONMENTAL HAZARDS 

E1 Hazardous to the Aquatic Environment in Category 

Acute 1 or Chronic 1  

E2 Hazardous to the Aquatic Environment in Category 

Chronic 2  

Qualifying quantity (tonnes) 

of substances  
as referred to in 
Article 3(9)  
for the application of 

Lower-tier 
requirements 

Upper-tier 
requirements 

5.000 

50.000 

10 

50 

50 

200 

50 

200 

50 

200 

100 

200 

200 

500 

EN 

45 

   EN 

 
 
 
Column 1 

Column 2 

Column 3 

Categories of dangerous substances and mixtures 

Qualifying quantity (tonnes) 

of substances  
as referred to in 
Article 3(9)  
for the application of 

Lower-tier 
requirements 

Upper-tier 
requirements 

Section ‘O’ – OTHER HAZARDS 

O1 Substances or mixtures with hazard statement EUH014 

O2  Substances  and  mixtures  which  in  contact  with  water  emit 

flammable gases, Category 1 

O3 Substances or mixtures with hazard statement EUH029 

100 

100 

50 

500 

500 

200 

EN 

46 

   EN 

 
 
PART 2 

Named substances 

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

Column 1 

CAS number 16

Column 2 

Column 3 

Qualifying  quantity  (tonnes)for 
the application of 

Lower-tier 
requirements 

Upper-tier 
requirements 

Dangerous substances 

Ammonium nitrate (note 13) 

Ammonium nitrate (note 14) 

Ammonium nitrate (note 15) 

Ammonium nitrate (note 16) 

Potassium nitrate (note 17) 

Potassium nitrate (note 18) 

- 

- 

- 

- 

- 

- 

5000 

1250 

350 

10 

5000 

1250 

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

1303-28-2 

1 

Arsenic  trioxide,  arsenious  (III)  acid
and/or salts 

1327-53-3 

Bromine 

Chlorine 

7726-95-6 

7782-50-5 

20 

10 

Nickel  compounds  in  inhalable  powder
form:  nickel  monoxide,  nickel  dioxide,
nickel  sulphide, 
trinickel  disulphide,
dinickel trioxide 

- 

Ethyleneimine 

Fluorine 

151-56-4 

7782-41-4 

Formaldehyde (concentration ≥ 90 %)  50-00-0 

Hydrogen 

1333-74-0 

10 

10 

5 

5 

16 

The CAS number is shown only for indication. 

10000 

5000 

2500 

50 

10000 

5000 

2 

0,1 

100 

25 

1 

20 

20 

50 

50 

EN 

47 

   EN 

 
 
 
 
 
                                                 
Hydrogen chloride (liquefied gas) 

7647-01-0 

Lead alkyls 

flammable  gases,  CLP-
Liquefied 
Category  1  or  2  (including  LPG)  and
natural gas 

Acetylene 

Ethylene oxide 

Propylene oxide 

Methanol 

- 

- 

74-86-2 

75-21-8 

75-56-9 

25 

5 

50 

5 

5 

5 

67-56-1 

500 

4-Methylenebis 
4, 
and/or salts, in powder form 

(2-chloraniline)

101-14-4 

Methylisocyanate 

624-83-9 

Oxygen 

7782-44-7 

200 

2,4 -Toluene diisocyanate  

2,6 -Toluene diisocyanate 

584-84-9 

91-08-7 

Carbonyl dichloride (phosgene) 

75-44-5 

Arsine (arsenic trihydride) 

7784-42-1 

Phosphine (phosphorus trihydride) 

7803-51-2 

10 

0,3 

0,2 

0,2 

Sulphur dichloride 

10545-99-0 

1 

Sulphur trioxide 

7446-11-9 

15 

and
Polychlorodibenzofurans 
(including
polychlorodibenzodioxins 
TCDD), calculated in TCDD equivalent
(note 19) 

- 

250 

50 

200 

50 

50 

50 

5000 

0,01 

0,15 

2000 

100 

0,75 

1 

1 

1 

75 

0,001 

EN 

48 

   EN 

 
 
 
 
 
The  following  CARCINOGENS  or  the
following
mixtures 
carcinogens at concentrations above 5%
by weight: 

containing 

the 

- 

its 

ether, 

and/or 

salts,
4-Aminobiphenyl 
and/or
Benzotrichloride,  Benzidine 
ether,
salts,  Bis 
(chloromethyl) 
1,2-
Chloromethyl  methyl 
Dibromoethane,  Diethyl 
sulphate,
Dimethyl  sulphate,  Dimethylcarbamoyl
chloride,  1,2-Dibromo-3-chloropropane,
1,2-Dimethylhydrazine, 
Dimethylnitrosamine, 
Hexamethylphosphoric 
triamide,
Hydrazine,  2-  Naphthylamine  and/or
salts, 
1,3
Propanesultone 

4-Nitrodiphenyl, 

and 

Petroleum products 

- 

(a) gasolines and naphthas, 

(b) kerosenes (including jet fuels), 

(c) gas oils (including diesel fuels, home 
heating  oils  and  gas  oil  blending
streams) 

(d) heavy fuel oil 

0,5 

2 

2500 

25000 

Anhydrous Ammonia 

7664-41-7 

50 

Boron trifluoride 

Hydrogen sulphide 

5 

5 

7637-07-2 

7783-06-4 

PART 3 

200 

20 

20 

Substances and mixtures excluded from this Directive pursuant to Article 2(2)(h) and 
Article 4(1) 

Name of 
substance/mixture 

CAS number 

Quantity (where 
applicable) 

Other conditions 
where applicable 

EN 

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NOTES TO ANNEX I 

Substances and mixtures are classified according to Regulation (EC) No 1272/2008 of 

1. 
the European Parliament and of the Council17. 

Mixtures  shall  be  treated  in  the  same  way  as  pure  substances  provided  they  remain 
2. 
within concentration limits set according to their properties under the Regulation given in Note 
1,  or  its  latest  adaptation  to  technical  progress,  unless  a  percentage  composition  or  other 
description is specifically given. 

3. 

The qualifying quantities set out below relate to each establishment. 

The quantities to be considered for the application of the relevant Articles are the maximum 
quantities which are present or are likely to be present at any one time. Dangerous substances 
present  at  an  establishment  only  in  quantities  equal  to  or  less  than  2  %  of  the  relevant 
qualifying quantity shall be ignored for the purposes of calculating the total quantity present if 
their location within an establishment is such that it cannot act as an initiator of a major accident 
elsewhere on the site. 

The  following  rules  governing  the  addition  of  dangerous  substances,  or  categories  of 

4. 
dangerous substances, shall apply where appropriate: 

In  the  case  of  an  establishment  where  no  individual  substance  or  mixture  is  present  in  a 
quantity  above  or  equal  to  the  relevant  qualifying  quantities,  the  following  rule  shall  be 
applied to determine whether the establishment is covered by the relevant requirements of this 
Directive. 

This Directive shall apply if the sum: 

q1/QU1 + q2/QU2 + q3/QU3 + q4/QU4 + q5/QU5 + . . . is greater than or equal to 1, 

where  qx  =  the  quantity  of  dangerous  substance  x  (or  category  of  dangerous 
substances) falling within Parts 1 or 2 of this Annex, 

and QUX = the relevant qualifying quantity for substance or category x from column 
3 of Parts 1 or 2. 

This Directive shall apply, with the exception of Articles 9, 11 and 13, if the sum: 

q1/QL1 + q2/QL2 + q3/QL3 + q4/QL4 + q5/QL5 + . . . is greater than or equal to 1, 

where  qx  =  the  quantity  of  dangerous  substance  x  (or  category  of  dangerous 
substances) falling within Parts 1 or 2 of this Annex, 

and QLX = the relevant qualifying quantity for substance or category x from column 2 
of Parts 1 or 2.  

17 

OJL 353, 31.12.2008, p.1 

EN 

50 

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This rule shall be used to assess the overall major accident hazards described in the 
three above sections: health hazards, physical hazards and environmental hazards. It 
must therefore be applied three times: 

(a) for the addition of substances and mixtures named in Part 2 that are classified as 
acute  toxicity  category  1,2  or  3,  together  with  substances  and  mixtures  falling  into 
section H: H1 to H3. 

(b) for the addition of substances and mixtures named in Part 2 that are classified as 
explosives,  flammable  gases,  flammable  aerosols,  oxidising  gases,  flammable 
liquids, self-reactive substances and mixtures, organic peroxides, pyrophoric liquids, 
oxidising  liquids  and  solids,  together  with  substances  and  mixtures  falling  into 
section P: P1 to P8. 

(c) for the addition of substances and mixtures named in Part 2 that are classified as 
hazardous  to  the  aquatic  environment,  acute  category  1,  chronic  category  1  or 
chronic category 2, together with substances and mixtures falling into section E: E1 
and E2. 

The relevant provisions of this Directive apply if any of the sums obtained by (a), (b) 
or (c) is greater than or equal to 1.  

5. 
In  the case of  substances and mixtures which are  not covered by  Annex I, including 
waste,  but  which  nevertheless  are  present,  or  are likely to be  present,  in  an  establishment  and 
which  possess  or  are  likely  to  possess,  under  the  conditions  found  at  the  establishment, 
equivalent  properties  in  terms  of  major-accident  potential,  Member  States  shall  provisionally 
assign  these  to  the  most  analogous  Seveso  category/named  substance  (pending  a  decision 
pursuant to Article 4(5) of this Directive). 

6. 
In  the  case  of  substances  and  mixtures  with  properties  giving  rise  to  more  than  one 
classification, for the purposes of this Directive the lowest qualifying quantities shall apply. 
However, for the application of the rule in Note 4, the qualifying quantity used shall always be 
the one corresponding to the classification concerned. 

7. 
In  the  case  of  substances  and  mixtures  falling  within  the  hazard  class  H2  ACUTE 
TOXIC, Category 3, dermal and inhalation exposure routes, where data for these route(s) are 
not  available,  extrapolation  from  other  route(s)  shall  be  performed  based  on  the  approach 
outlined  in  Regulation  (EC)  No.  1272/2008  on  classification,  labelling  and  packaging  of 
substances and mixtures (in particular point 3.1.3.6.2.1. (a) and table 3.1.2 in Annex 1) and 
Regulation  (EC)  No  1907/2006  concerning  the  Registration,  Evaluation,  Authorisation  and 
Restriction of Chemicals (REACH) (in particular Annex I, section 5.2 (exposure estimation)), 
as well as the related guidance, available at: 

http://guidance.echa.europa.eu/docs/guidance_document/clp_en.pdf (as of page 204). 

8. 
The hazard class Explosives includes explosive articles (see Section 2.1 of Annex I of 
the  CLP-Regulation).  If  the  quantity  of  the  explosive  substance  or  mixture  contained  in  the 
article  is  known,  that  quantity  shall  be  considered  for  the  purposes  of  this  Directive.  If  the 
quantity of the explosive substance or mixture contained in the article is not known, then, for 
the purposes of this Directive, the whole article shall be treated as explosive. 

EN 

51 

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9. 
Testing  for  explosive  properties  of  substances  and  mixtures  is  only  necessary  if  the 
screening procedure according to Appendix 6 (Part 3) of the UN Manual of Tests and Criteria 
18 identifies the substance/mixture as potentially having explosive properties.  

10. 
If Explosives of Division 1.4 are unpacked or repacked, they shall be assigned to the 
entry P3,  unless  the  hazard  is shown to still correspond to Division 1.4, in accordance  with 
Regulation (EC) No 1272/2008.  

11.1.  Flammable  aerosols  are  classified  in  accordance  to  the  Aerosol  Dispensers  Directive 
75/324/EEC19.  ‘Extremely  flammable’  and  ‘Flammable’  aerosols  of  Directive  75/324/EEC 
correspond  to  Flammable  Aerosols  Category  1  or  2  respectively  of  Regulation  (EC)  No 
1272/2008. 

In order to use this entry, it must be documented that the aerosol dispenser does not 

11.2. 
contain Flammable Gas Category 1 or 2 nor Flammable Liquid Category 1. 

According to 2.6.4.5 in Annex I to Regulation (EC) No 1272/2008, liquids with a flash 
12. 
point  of  more  than  35  °C  need  not  be  classified  in  Category  3  if  they  do  not  sustain 
combustion. This is however not valid under elevated conditions such as high temperature or 
pressure, and therefore such liquids are included in this entry. 

13. 

Ammonium nitrate (5000 / 10000): fertilisers capable of self-sustaining decomposition 

to 

applies 

ammonium 

This 
fertilisers 
nitrate-based 
(compound/composite  fertilisers  contain  ammonium  nitrate  with  phosphate  and/or  potash) 
which  are  capable  of  self-sustaining  decomposition  according  to  the  UN  Trough  Test  (see 
United  Nations  Recommendations  on  the  Transport  of  Dangerous  Goods:  Manual  of  Tests 
and  Criteria,  Part  III,  subsection  38.2),  and  in  which  the  nitrogen  content  as  a  result  of 
ammonium nitrate is 

compound/composite 

– 

– 

between 15,75 %20 and 24,5 %21 by weight, and either with not more than 0,4 % total 
combustible  /  organic  materials  or  which  fulfil  the  requirements  of  Annex  III-2  of 
Regulation (EC) No 2003/2003 of the European Parliament and of the Council22; 

15,75 % by weight or less and unrestricted combustible materials. 

14. 

Ammonium nitrate (1250 / 5000): fertiliser grade 

This  applies  to  straight  ammonium  nitrate-based  fertilisers  and  to  ammonium  nitrate-based 
compound  fertilisers  which  fulfil  the  requirements  of  Annex  III-2  to  Regulation  (EC)  No 
2003/2003 and in which the nitrogen content as a result of ammonium nitrate is 

18 

19 
20 

21 

22 

More  guidance  on  waiving  of  the  test  can  be  found  in  the  A.14  method  description,  see  Regulation  (EC)  No 
440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European 
Parliament  and  of  the  Council  on  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals 
(REACH) (OJ L 142, 31.5.2008, p. 1) 
OJL 147, 9.6.1975, p. 40 
15,75 % nitrogen content by weight as a result of ammonium nitrate corresponds to 45 % ammonium 
nitrate. 
24,5  %  nitrogen  content  by  weight  as  a  result  of  ammonium  nitrate  corresponds  to  70  %  ammonium 
nitrate. 
OJL 304, 21.11.2003, p. 1 

EN 

52 

   EN 

                                                 
– 

– 

– 

more than 24,5 % by weight, except for mixtures of straight ammonium nitrate-based 
fertilisers with dolomite, limestone and/or calcium carbonate with a purity of at least 
90 %; 

more  than  15,75  %  by  weight  for  mixtures  of  ammonium  nitrate  and  ammonium 
sulphate; 

more  than  28  %23  by  weight  for  mixtures  of  straight  ammonium  nitrate-based 
fertilisers with dolomite, limestone and/or calcium carbonate with a purity of at least 
90 %. 

15. 

Ammonium nitrate (350 / 2500): technical grade 

This  applies  to  ammonium  nitrate  and  mixtures  of  ammonium  nitrate  in  which  the  nitrogen 
content as a result of the ammonium nitrate is 

– 

– 

between  24,5  %  and  28  %  by  weight,  and  which  contain  not  more  than  0,4  % 
combustible substances; 

more  than  28  %  by  weight,  and  which  contain  not  more  than  0,2  %  combustible 
substances. 

It  also  applies  to  aqueous  ammonium  nitrate  solutions  in  which  the  concentration  of 
ammonium nitrate is more than 80 % by weight. 

Ammonium  nitrate  (10  /  50):  “off-specs”  material  and  fertilisers  not  fulfilling  the 

16. 
detonation test 

This applies to 

– 

– 

material  rejected  during  the  manufacturing  process  and  to  ammonium  nitrate  and 
mixtures  of  ammonium  nitrate,  straight  ammonium  nitrate-based  fertilisers  and 
ammonium  nitrate-based  compound/composite fertilisers referred to in Notes 2 and 
3,  that  are  being  or  have  been  returned  from  the  final  user  to  a  manufacturer, 
temporary  storage  or  reprocessing  plant  for  reworking,  recycling  or  treatment  for 
safe use, because they no longer comply with the specifications of Notes 2 and 3; 

fertilisers  referred  to  in  Note  1,  first  indent,  and  Note  2  which  do  not  fulfil  the 
requirements of Annex III-2 to Regulation (EC) No 2003/2003. 

17. 

Potassium nitrate (5000 / 10000) 

This  applies  to  those  composite  potassium-nitrate  based  fertilisers  (in  prilled/granular)  form 
which have the same hazardous properties as pure potassium nitrate. 

18. 

Potassium nitrate (1250 / 5000) 

This applies to those composite potassium-nitrate based fertilisers (in crystalline) form which 
have the same hazardous properties as pure potassium nitrate. 

23 

28  %  nitrogen  content  by  weight  as  a  result  of  ammonium  nitrate  corresponds  to  80  %  ammonium 
nitrate. 

EN 

53 

   EN 

                                                 
19. 

Polychlorodibenzofurans and polychlorodibenzodioxins 

The quantities of polychlorodibenzofurans and polychlorodibenzodioxins are calculated using 
the following factors:  

WHO 2005 TEF 

2,3,7,8-TCDD 

1,2,3,7,8-PeCDD 

1 

1 

2,3,7,8-TCDF 

2,3,4,7,8-PeCDF 

0,1 

0,3 

1,2,3,7,8-PeCDF 

0,03 

1,2,3,4,7,8-HxCDD 

0,1 

1,2,3,6,7,8-HxCDD 

0,1 

1,2,3,4,7,8-HxCDF 

0,1 

1,2,3,7,8,9-HxCDD 

0,1 

1,2,3,7,8,9-HxCDF 

0,1 

1,2,3,6,7,8-HxCDF 

0,1 

1,2,3,4,6,7,8-HpCDD  0,01 

2,3,4,6,7,8-HxCDF 

0,1 

OCDD 

0,0003 

1,2,3,4,6,7,8-HpCDF  0,01 

1,2,3,4,7,8,9-HpCDF  0,01 

OCDF 

0,0003 

(T = tetra, P = penta, Hx = hexa, Hp = hepta, O = octa) 

Reference  -  Van  den  Berg  et  al:  The  2005  World  Health  Organization  Re-
evaluation  of  Human  and  Mammalian  Toxic  Equivalency  Factors  for  Dioxins
and Dioxin-like Compounds 

EN 

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ANNEX II 

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

1. 

Information on the management system and on the organization of the establishment 
with a view to major accident prevention 

This information shall contain the elements given in Annex III. 

2. 

Presentation of the environment of the establishment 

description of the site and its environment including the geographical location, 

(a) 
meteorological, geological, hydrographic conditions and, if necessary, its history; 

identification  of  installations  and  other  activities  of  the  establishment  which 

(b) 
could present a major-accident hazard;  

(c) 
identification of neighbouring establishments, as well as other sites, areas and 
developments that could increase the risk or consequences of a major accident and of 
domino effects; 

(d)  description of areas where a major accident may occur. 

3. 

Description of the installation 

(a) 
description of the main activities and products of the parts of the establishment 
which are important from the point of view of safety, sources of major-accident risks 
and  conditions  under  which  such  a  major  accident  could  happen,  together  with  a 
description of proposed preventive measures; 

(b)  description of processes, in particular the operating methods; 

(c) 

description of dangerous substances: 

(i) 

inventory of dangerous substances including: 

- 

- 

the  identification  of  dangerous  substances:  chemical  name,  CAS 
number, name according to IUPAC nomenclature, 

the maximum quantity of dangerous substances present or likely to 
be present; 

(ii)  physical,  chemical,  toxicological  characteristics  and  indication  of  the 
hazards,  both  immediate  and  delayed  for  human  health  and  the 
environment; 

(iii)  physical and chemical behaviour under normal conditions of use or under 

foreseeable accidental conditions. 

4. 

Identification and accidental risks analysis and prevention methods 

EN 

55 

   EN 

(a) detailed description of the possible major-accident scenarios and their probability 
or the conditions under which they occur including a summary of the events which 
may  play  a  role  in  triggering  each  of  these  scenarios,  the  causes  being  internal  or 
external to the installation; including in particular 

(i) 

operational hazard sources;  

(ii) 

external  risks  and  hazard  sources,  from  domino  effects  and  from  other 
sites,  areas  and  developments 
the  risk  or 
consequences of a major accident; 

that  could 

increase 

(iii)  environmental  risks  and  hazard  sources,  for  example  earthquakes  or 

floods; 

(b) 
assessment of the extent and severity of the consequences of identified major 
accidents  including  maps,  images  or,  as  appropriate,  equivalent  descriptions, 
showing  areas  which  are  liable  to  be  affected  by  such  accidents  arising  from  the 
establishment, subject to the provisions of Articles 13(2) (b) and 21; 

(c) 
review of past accidents and incidents with the same substances and processes 
used, consideration  of  lessons learned from these, and explicit reference to specific 
measures taken to prevent such accidents; 

(d)  description  of  technical  parameters  and  equipment  used  for  the  safety  of 
installations. 

5. 

Measures of protection and intervention to limit the consequences of an accident 

(a) 
description of the equipment installed in the plant to limit the consequences of 
major  accidents  for  human  health  and  environment,  including  for  example 
detection/protection  systems,  technical  devices  for  limiting  the  size  of  accidental 
releases (including water spray; vapour screens, emergency catch pots or collection 
vessels, shut-of valves; inerting systems; fire water retention); 

(b)  organization of alert and intervention; 

(c) 

description of mobilizable resources, internal or external; 

summary of elements described in point (a), (b) and (c) necessary for drawing 

(d) 
up the internal emergency plan prepared in compliance with Article 11. 

EN 

56 

   EN 

ANNEX III 

INFORMATION REFERRED TO IN ARTICLE 9 ON THE MANAGEMENT 
SYSTEM AND THE ORGANISATION OF THE ESTABLISHMENT WITH A VIEW 
TO THE PREVENTION OF MAJOR ACCIDENTS 

For the purpose of implementing the operator's safety management system, account shall be taken 
of the following elements: 

the safety management system shall be proportionate to the hazards, industrial activities 
(a) 
and  complexity  of  the  organisation  in  the  establishment  and  be  based  on  assessment  of  the 
risks.  It  should  include  the  part  of  the  general  management  system  which  includes  the 
organizational  structure,  responsibilities,  practices,  procedures,  processes  and  resources  for 
determining and implementing the major-accident prevention policy. Other existing management 
systems including ISO, OSHAS, EMAS shall be taken into account; 

(b) 

the following issues shall be addressed by the safety management system: 

(i)  organisation  and  personnel  —  the  roles  and  responsibilities  of  personnel  involved  in  the 
management of major hazards at all levels in the organisation. The identification of training 
needs  of  such  personnel  and  the  provision  of  the  training  so  identified.  The  involvement  of 
employees and of subcontracted personnel working in the establishment; 

(ii)  identification  and  evaluation  of  major  hazards  —  adoption  and  implementation  of 
procedures  for  systematically  identifying  major  hazards  arising  from  normal  and  abnormal 
operation and the assessment of their likelihood and severity; 

(iii)  operational  control  —  adoption  and  implementation  of  procedures  and  instructions  for 
safe operation, including maintenance, of plant, processes, equipment, alarm management and 
temporary stoppages; 

(iv)  management  of  change  —  adoption  and  implementation  of  procedures  for  planning 
modifications to, or the design of new installations, processes or storage facilities; 

(v) safety culture — measures to assess and improve safety culture; 

(vi)  planning  for  emergencies  —  adoption  and  implementation  of  procedures  to  identify 
foreseeable emergencies by systematic analysis, to prepare, test and review emergency plans 
to respond to such emergencies and to provide specific training for the staff concerned. Such 
training  shall  be  given  to  all  personnel  working  in  the  establishment,  including  relevant 
subcontracted personnel; 

(vii) monitoring performance — adoption and implementation of procedures for the ongoing 
assessment of compliance with the objectives set by the operator's major-accident prevention 
policy  and  safety  management  system,  and  the  mechanisms  for  investigation  and  taking 
corrective action in case of non-compliance. The procedures shall cover the operator's system 
for reporting major accidents of near misses, particularly those involving failure of protective 
measures, and their investigation and follow-up on the basis of lessons learnt. The procedures 
could also include performance indicators such as safety performance indicators (SPIs) and or 
other relevant indicators; 

EN 

57 

   EN 

(viii) audit and review — adoption and implementation of procedures for periodic systematic 
assessment of the major-accident prevention policy and the effectiveness and suitability of the 
safety management system; the documented review of performance of the policy and safety 
management  system  and  its  updating  by  senior  management,  including  consideration  and 
incorporation of necessary changes indicated by the audit. 

EN 

58 

   EN 

ANNEX IV 

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

1. 

Internal emergency plans 

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

(a) 

(b) 

(c) 

(d) 

(e) 

2. 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

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. 

Arrangements for providing assistance with off-site mitigatory action. 

External emergency plans 

Names or positions of persons authorized to set emergency procedures in motion and of 
persons authorized to take charge of and coordinate offsite 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. 

Arrangements for providing assistance with on-site mitigatory action. 

Arrangements  for  off-site  mitigatory  action,  including  responses  to  major  accident 
scenarios  as  set  out  in  the  safety  report,  including  those  having  an  impact  on  the 
environment. 

Arrangements  for  providing  the  public  and  any  neighbouring  establishments  in 
accordance  with  Article  8  with  specific  information  relating  to  the  accident  and  the 
behaviour which should be adopted. 

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. 

EN 

59 

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ANNEX V 

ITEMS OF INFORMATION TO THE PUBLIC AS PROVIDED FOR IN ARTICLE 13 
(1) and (2)(a) 

Part 1  

For all establishments covered by this Directive: 

Name  or  trade  name  of  the  operator  and  the  full  address  of  the  establishment 
concerned. 

that 

the  establishment 

the  regulations  and/or 
Confirmation 
administrative  provisions  implementing  this  Directive  and  that  the  notification 
referred  to  in  Article  6(1)  or  the  safety  report  referred  to  in  Article  9(1)  has  been 
submitted to the competent authority. 

is  subject 

to 

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  1  of 
Annex  1,  the  generic  names  or  the  hazard  classification  of  the  substances  and 
mixtures  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,  as  set  out  in  major 
accident prevention policy or in the safety report. 

Summary details of the inspections carried out pursuant to Article 19 and of the main 
findings from the latest inspection conclusions, together with a reference or /link to 
the related inspection plan. 

Details  of  where  further  relevant  information  can  be  obtained,  subject  to  the 
requirements of Article 21 on confidentiality. 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

Part 2 

For upper-tier establishments, in addition to the information referred to in Part 1 of this 
Annex: 

1. 

2. 

3. 

Summary details of the main types of major-accident scenarios and the main types of 
events which may play a role in triggering each of these scenarios. 

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. 

EN 

60 

   EN 

4. 

5. 

6. 

Confirmation that the operator is required to make adequate arrangements on site, in 
particular  liaison  with  the  emergency  services,  to  deal  with  major  accidents  and  to 
minimize their effects. 

Appropriate  information  from  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. 

Where  applicable,  indication  whether  the  establishment  is  close  to  the  territory  of 
another  Member  State  with  the  possibility  of  a  major  accident  with  transboundary 
effects  under  the  UNECE  Convention  on  the  Transboundary  Effects  of  Industrial 
Accidents. 

EN 

61 

   EN 

ANNEX VI 

CRITERIA FOR THE NOTIFICATION OF AN ACCIDENT TO THE COMMISSION 
AS PROVIDED FOR IN ARTICLE 16 (1) 

I. Any accident covered by paragraph 1 or having at least one of the consequences described in 
paragraphs 2, 3, 4 and 5 must be notified to the Commission. 

1. 

Substances involved 

Any fire or explosion or accidental discharge of a dangerous substance involving a quantity of at 
least 1 % of the qualifying quantity laid down in column 3 of Annex I.  

2. 

Injury to persons and damage to real estate 

An  accident  directly  involving  a  dangerous  substance  and  giving  rise  to  one  of  the  following 
events: 

(a) 

a death; 

(b) 

six  persons  injured  within  the  establishment  and  hospitalized  for  at  least  24 
hours; 

(c) 

one person outside the establishment hospitalized for at least 24 hours; 

(d)  dwelling(s) outside the establishment damaged and unusable as a result of the 

accident; 

(e) 

(f) 

the  evacuation  or  confinement  of  persons  for  more  than  2  hours  (persons  × 
hours): the value is at least 500; 

the  interruption  of  drinking  water,  electricity,  gas  or  telephone  services  for 
more than 2 hours (persons × hours): the value is at least 1 000. 

3. 

Immediate damage to the environment 

(a) 

permanent or long-term damage to terrestrial habitats: 

(i) 

0,5 ha or more of a habitat of environmental or conservation importance 
protected by legislation, 

(ii)  10  or  more  hectares  of  more  widespread  habitat,  including  agricultural 

land, 

(b) 

significant or long-term damage to freshwater and marine habitats: 

(i) 

10 km or more of river or canal, 

(ii)  1 ha or more of a lake or pond, 

(iii)  2 ha or more of delta, 

(iv)  2 ha or more of a coastline or open sea, 

EN 

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(c) 

significant damage to an aquifer or underground water: 

(i) 

1 ha or more. 

4. 

Damage to property 

(a) 

damage to property in the establishment: at least 2 million euros, 

(b)  damage to property outside the establishment: at least 0,5 million euros. 

5. 

Cross-border damage 

Any  accident  directly  involving  a  dangerous  substance  giving  rise  to  effects  outside  the 
territory of the Member State concerned. 

II.  Accidents  or  'near  misses'  which  Member  States  regard  as  being  of  particular  technical 
interest for preventing major accidents and limiting their consequences and which do not meet 
the quantitative criteria above should be notified to the Commission. 

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ANNEX VII 

CRITERIA FOR DEROGATIONS PURSUANT TO ARTICLE 4 

EN 

64 

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ANNEX VIII 

CORRELATION TABLE 

Directive 96/82/EC 

Article 1 

Article 2(1) first subparagraph 

This Directive 

Article 1 

Article 2(1) 

Article 2(1) second subparagraph 

Article 3(11) 

Article 2(2) 

Article 3(1) 

Article 3(2) 

Article 3(3) 

Article 3(4) 

Article 3(5) 

Article 3(6) 

Article 3(7) 

Article 3(8) 

--- 

Article 4 

--- 

Article 5 

Article 6(1) 

Article 6(2)(a)-(g) 

--- 

Article 6(3) 

Article 6(4) 

--- 

Article 7(1) 

--- 

Article 3(1) 

Article 3(7) 

Article 3(8) 

Article 3(9) 

Article 3(12) 

Article 3(13) 

Article 3(14) 

Article 3(15) 

Article 3(2)-(6),(10)-(11) and (16)-(18) 

Article 2(2)(a)-(g) 

Article 4 

Article 5 

Article 6(2) 

Article 6(1)(a)-(g) 

Article 6(1)(h) 

Article 6(3) 

Article 6(4) 

Article 6(5) 

Article 7(1) 

EN 

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   EN 

--- 

Article 7(1a) 

Article 7(2) 

Article 7(3) 

--- 

--- 

Article 8 

Article 9(1) 

Article 9(2) first subparagraph 

Article 7(2)(a)-(b) 

Article 7(2)(c) 

--- 

--- 

Article7(3) 

Article 7(4) 

Article 8 

Article 9(1) 

Article 9(2) 

Article 9(2) second subparagraph 

--- 

Article 9(3) 

Article 9(4) 

Article 9(5) 

Article 9(6) 

--- 

Article 10 

Article 11(1)(a)-(b) 

Article 11(1)(c) 

Article 11(2) 

Article 11(3) 

Article 11(4) 

Article 11(4a) 

Article 11(5) 

Article 11(6) 

Article 12(1) first subparagraph 

Article 9(3) 

Article 9(6) 

Article 9(5) 

--- 

Article 9(4) and ((7) 

Article 10 

Article 11(1)(a)-(b) and 11(2) 

Article 11(1)(c) 

Article 11(3) 

Article 11(4) 

Article 11(5) first subparagraph 

Article 11(5) second subparagraph 

Article 11(6) 

Article 11(7) 

Article 12(1) 

Article 12(1) second subparagraph 

Article 12(2) 

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Article 12(1a) 

Article 12(2) 

--- 

--- 

Article 12(3) 

Article 12(4) 

Article 13(1) first subparagraph 

Article 13(2) first subparagraph (a) and second 
subparagraph 

Article  13(1)  second  subparagraph,  first  and 
third sentences 

Article  13(1)  and  Article  13(2)  second 
subparagraph last sentence 

Article  13(1)  second  subparagraph,  second 
sentence 

Article 13(1)  

Article 13(1) third subparagraph 

--- 

Article 13(2) 

Article 13(3) 

Article 13(4) 

Article 13(5)  

Article 13(6) 

--- 

--- 

--- 

Article 14 

Article 15 

Article 16 

--- 

Article 17 

Article 18(1) 

Article 18(2) (a) 

Article 18(2)(b)-(c) 

Article  13(1)  and  Article  13(2)  second 
subparagraph first sentence 

Article 13(1) second subparagraph 

Article 13(4) 

Article 13(5) 

Article 13(2)(b) 

Article 14(1) 

Article 13(2)(c) 

Article 13(3) 

Article 13(6) 

Article 14(2)-(7) 

Article 15 

Article 16 

Article 17(1) 

Article 17(2)-(3) 

Article 18 

Article 19(1)-(2) 

Article 19(4) 

Article 19(7) 

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Article 18(3) 

--- 

Article 19(1) 

Article 19(10) 

Article 19(3),(5),(6), (8) and (9) 

Article 20(1) 

Article 19(1a) first subparagraph 

Article 20(2) 

Article  19(1a)  second  subparagraph  first 
sentence 

Article 20(3) 

Article  19(1a)  second  subparagraph  second 
sentence 

--- 

Article 19(2) first subparagraph 

Article 20(5) 

Article 19(2) second subparagraph 

Article 20(6) 

Article 19(3) 

Article 19(4) 

Article 20(1) first subparagraph 

--- 

Article 20(4) 

Article 21(1) 

Article 20(1) second subparagraph 

Article 21(2) 

Article 20(2) 

--- 

--- 

Article 21 

Article 22 

Article 23 

Article 24 

Article 25 

Article 26 

--- 

--- 

Article 21(3) 

Article 22 

Article 23 

--- 

Article 29 

Article 28 

Article 30 

Article 31 

Articles 24-27 

Annex I, Introduction, paragraphs 1-5 

Annex I, Notes to Annex I, paragraphs 1-4 

Annex I, Introduction, paragraphs 6-7 

--- 

Annex I, Part 1 

Annex I, Part 2 

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Annex I, Part1, Notes 

Annex I, notes to Annex I, paragraphs 13-19 

Annex I, Part 2 

Annex I, Part 1 

Annex I, Part 2, Notes, paragraph 1 

Annex I, Notes to Annex I, paragraphs 1 and 5-
7 

Annex I, Part 2, Notes, paragraph 2 

Annex I, Notes to Annex I, paragraphs 8-10 

Annex I, Part 2, Notes, paragraph 3 

Annex I, Notes to Annex I, paragraphs 11-12 

Annex I, Part 2, Notes, paragraph 4 

Annex I, Notes to Annex I, paragraph 4 

--- 

Annex II, I-III 

Annex II, IV, A 

--- 

Annex II, IV, B 

--- 

Annex II, IV, C 

Annex II, V 

Annex I, Part 3 

Annex II, 1-3 

Annex II, 4, A 

Annex II, 4, A, first, second and third indents 

Annex II, 4, B 

Annex II, 4,C 

Annex II, 4,D 

Annex II, 5 

Annex  III,  introductory  paragraph  and  points 
(a)-(b) 

Annex III, introductory paragraphs 

Annex III, point (c), items (i)-(iv) 

Annex III, points (i)-(iv) 

--- 

Annex III, point (v) 

Annex III, point (c), items (v)-(vii) 

Annex III, points (vi)-(viii) 

Annex IV 

Annex V, point 1 

Annex V, point 2 

Annex IV 

Annex V, I, point 1 

--- 

Annex V, points 3-6 

Annex V, I, points 2-5 

--- 

Annex V, points 7-10 

Annex V, point 11 

Annex V, I, point 6 

Annex V, II, points 2-5 

Annex V, I, point 7 

EN 

69 

   EN 

--- 

Annex VI, I 

Annex VI, II 

--- 

--- 

Annex V, II, points I and 6 

Annex VI, I 

--- 

Annex VII 

Annex VIII 

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