COMMISSION STAFF WORKING PAPER IMPACT ASSESSMENT Accompanying document to the  Proposal for a  DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the control of major-accident hazards involving dangerous substances     COM(2010) 781 final SEC(2010) 1591 final
Date: 2010-12-21
Institutions: European Commission
Subjects: dangerous substance, environmental risk prevention, exchange of information, industrial hazard, public health, safety standard

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EUROPEAN COMMISSION 

Brussels, 21.12.2010 
SEC(2010) 1590 final 

COMMISSION STAFF WORKING PAPER 

IMPACT ASSESSMENT 
Accompanying document to the 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the 
control of major-accident hazards involving dangerous substances 

COM(2010) 781 final 
SEC(2010) 1591 final 

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COMMISSION STAFF WORKING PAPER 

IMPACT ASSESSMENT 
Accompanying document to the 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the 
control of major-accident hazards involving dangerous substances 

Lead DG:                               DG ENV 

Other involved services: 

DGs CLIMA, EMPL, ENER, ENTR, JRC, MOVE, SANCO, SJ, 
SG. 

Agenda planning: 

2010/ENV/006 

The report commits only the Commission's services involved in the preparation and the text is 
prepared as a basis for comment and does not prejudice the final form of any decision to be 
taken by the Commission 

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TABLE OF CONTENTS 

Procedural issues and consultation of interested parties .............................................. 6 

Overview ...................................................................................................................... 6 

Inter-Service Steering Group ....................................................................................... 6 

Expertise and information ............................................................................................ 6 

Stakeholder consultation .............................................................................................. 7 

The Impact Assessment Board..................................................................................... 7 

Problem definition........................................................................................................ 8 

Policy issue 1: Alignment of Annex I to the CLP...................................................... 10 

Policy issue 2: Other technical amendments to Annex I............................................ 11 

Policy issue 3: Procedures for adapting Annex I in the future................................... 11 

Policy issue 4: Information to the public and information management systems, 
including reporting ..................................................................................................... 12 

Policy issue 5: Land-use planning ............................................................................. 13 

Policy issue 6: Other areas where implementation could be improved ..................... 13 

Objectives................................................................................................................... 14 

Policy options............................................................................................................. 15 

Policy issue 1: Alignment of Annex I to the CLP...................................................... 15 

Policy issue 2: Other technical amendments to Annex I............................................ 16 

Policy issue 3: Procedures for adapting Annex I in the future................................... 16 

Policy issue 4: Information to the public and information management systems 
including reporting ..................................................................................................... 17 

Policy issue 5: Land-use planning ............................................................................. 18 

Policy issue 6: clarifications to facilitate effective implementation .......................... 18 

Analysis of impacts .................................................................................................... 18 

Policy issue 1: Alignment of Annex I to the CLP...................................................... 19 

Policy issue 2: Other technical amendments to Annex I............................................ 22 

Policy issue 3:  Procedures for adapting Annex I in the future.................................. 24 

Policy issue 4: Information to the public and information management systems 
including reporting ..................................................................................................... 26 

1. 

1.1. 

1.2. 

1.3. 

1.4. 

1.5. 

2. 

2.1. 

2.2. 

2.3. 

2.4. 

2.5. 

2.6. 

3. 

4. 

4.1. 

4.2. 

4.3. 

4.4. 

4.5. 

4.6. 

5. 

5.1. 

5.2. 

5.3. 

5.4. 

5.5. 

Policy issue 5: Land-use planning ............................................................................. 28 

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5.6. 

Policy issue 6: Clarifications to facilitate effective implementation ......................... 29 

6. 

6.1. 

6.2. 

6.3. 

6.4. 

6.5. 

6.6. 

6.7. 

6.8. 

6.9. 

Comparing the options ............................................................................................... 31 

Policy issue 1: Alignment of Annex I to the CLP...................................................... 31 

Policy issue 2: Other technical amendments to Annex I............................................ 33 

Policy issue 3: Procedures for amending Annex I in the future................................. 34 

Policy issue 4: Information to the public and information management systems 
including reporting ..................................................................................................... 35 

Policy issue 5: Land-use planning ............................................................................. 36 

Policy issue 6: Clarifications to facilitate effective implementation ......................... 36 

Summary Table .......................................................................................................... 37 

Effect on SMEs .......................................................................................................... 40 

The social impacts, effects on human health, environment, employment, and other 
effects ......................................................................................................................... 41 

6.10 

Simplification............................................................................................................. 41   

6.11. 

Subsidiarity and proportionality................................................................................. 41   

7. 

Monitoring and evaluation ......................................................................................... 42 

ANNEXES 

ANNEX I: REFERENCES ...................................................................................................... 44 

ANNEX II: POLICY OPTIONS - DETAILED DESCRIPTION, INCL. OPTIONS 
DISCARDED AT AN EARLY STAGE.................................................................................. 45 

ANNEX III:STAKEHOLDER CONSULTATION................................................................. 54 

ANNEX IV:BACKGROUND INFORMATION ON DIRECTIVE'S REQUIREMENTS..... 56 

ANNEX V: EXISTING INFORMATION OBLIGATIONS UNDER DIRECTIVE.............. 61 

ANNEX VI: POLICY ISSUE 6: CLARIFICATIONS TO FACILITATE EFFECTIVE 
IMPLEMENTATION .............................................................................................................. 62 

ANNEX VII:  ANNEX I  ISSUES........................................................................................... 68 

ANNEX VIII: COST ASSUMPTIONS................................................................................... 75 

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ANNEX IX: COSTS AND BENEFITS OF OPTIONS FOR POLICY ISSUE 3 ................... 91 

ANNEX X: COSTS AND BENEFITS OF OPTIONS FOR POLICY ISSUE 4..................... 93 

ANNEX XI: COSTS AND BENEFITS OF OPTIONS FOR POLICY ISSUE 6 ................... 97 

ANNEX XII SUMMARY TABLE OF OPTIONS (DETAILED VERSION) ...................... 103 

ANNEX XIII: GLOSSARY................................................................................................... 107 

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1. 

PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES 

1.1. 

Overview 

A review of the so-called Seveso II Directive 96/82/EC (1) on the control of major-
accident hazards involving dangerous substances has been ongoing for the last two 
years. The main driver for this is the need to amend the Directive due to changes in 
the  EU  system  of  classification  of  chemicals.  However  the  opportunity  has  been 
taken  to  examine  whether  any  other  amendments  to  the  Directive  would  also  be 
appropriate.  

A revision of the Directive is a catalogue item in the 2010 Commission Legislative 
and  Work  Programme  (CLWP)  with  an  accompanying  roadmap  as  set  out  at 
http://ec.europa.eu/governance/impact/planned_ia/roadmaps_2010_en.htm. 

It  is  also  included  in  the  Commission  strategy  for  simplifying  the  regulatory 
environment (3) and identified as a candidate in the list of simplification initiatives 
listed in Annex III to the CLWP 2010. 

A number of stakeholders, experts and competent authorities  of the  Member States 
have been consulted. An Inter-Service Steering Group to support the overall review 
process, including work on the related Impact Assessment, was established.  

1.2. 

Inter-Service Steering Group 

Within  the  Commission,  internal  consultation  has  been  pursued  through  an  Inter-
Service Steering Group (ISSG) for the GHS alignment set up in 2008, which met on 
23 October 2008, 16 September 2009 and 22 March 2010 and had a several informal 
contacts  during  the  same  period;  and  an  Inter-service  Co-ordination  Group, 
established  in  February  2010,  which  has  also  served  as  the  ISSG  for  the  overall 
review, and met on 9 March 2010, 1 June 2010, 1 July 2010, and 26 July 2010. The 
ISSG reviewed the two impact assessment studies on which this report is based. The 
final draft of this report was sent on 16 July to the members of the ISSG for written 
comment  and  their  comments  taken  into  account.  The  ISSG  was  led  by  the 
Directorate-General  Environment  with  the  participation  of  DGs  Climate  Action, 
Employment,  Energy,  Enterprise  and  Industry,  Health  and  Consumer  Protection, 
Home Affairs, Joint Research Centre, Mobility and Transport, the Legal Service and 
the Secretariat General.   

1.3. 

Expertise and information 

As  part  of  the  preparatory  work  of  the  review  process,  and  to  support  this  impact 
assessment, several studies were carried out by external contractors. The studies are 
listed in Annex I (4)-(8). The review has also taken into account experience gained 
on implementation of the Directive since its adoption, and in particular the findings 
from  the  three-yearly  reports  from  Member  States  on  implementation  of  the 
Directive, the latest of which, for the period 2006-2008, has recently been published 
on DG ENV's website, at:  
http://ec.europa.eu/environment/seveso/implementation.htm. 

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This report is mainly based on the information gathered in the context of this process. 
Wherever possible a quantitative assessment has been made of the economic, social 
and  environmental  impacts  of  the  various  policy  options  based  on  the  studies  and 
other inputs. Where such data, could not be obtained or is uncertain, the analysis of 
the  policy  options  is  more  qualitative  in  line  with  the  principle  of  a  proportionate 
level  of  analysis.  All  cost  and  other  data  are  based  on  those  contained  in  the  two 
impact assessment studies referred to in Annex I ((7) and (8)), conducted by COWI 
A/S. 

1.4. 

Stakeholder consultation 

the 

review  process,  stakeholders 

During 
industry 
associations,  NGOs,  Member  State  competent  authorities)  were  consulted  in  a 
number of ways:   

(individual  companies, 

•  Web-based  questionnaires    available  for  all  stakeholders  and  selected  follow-up 
interviews with a  representative  sample as  part  of  the  two    studies  assessing  the 
effectiveness of the Directive referred to in Annex I ((4) and (5); 

•  Consultation  of  competent  authorities  in  the  Member  States  through  the 
committee  of  competent  authorities  (CCA)  at  its  regular  six-monthly  meetings, 
and related seminars; 

•  On the GHS alignment, via 6 meetings of a technical working group, comprising 

experts from Member States, industry and environmental NGOs; 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.  

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

In the light of the above, the stakeholder consultation in the review process has been 
carried out according to the Commission's general principles and minimum standards 
for consultation (9). 

1.5. 

The Impact Assessment Board 

This  Impact  Assessment  was  submitted  to  the  Board  on  23  August  2010  and 
discussed  at  the  Board  meeting  of  22  September  2010.  The  Board  submitted  its 
opinion  on  24  September  2010  proposing  the  following  main  changes  to  the 
assessment: 

- strengthening the problem definition and providing a clearer explanation of current 
deficiencies in implementation 

-  providing  a  more  transparent  presentation  of  the  practical  implications  of  the 
options related to land-use planning and information to the public 

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-  providing  a  more  detailed  analysis  of  costs  and  benefits  of  the  proposed  policy 
options,  especially  with  regard  to  compliance  costs  and  possible  simplification 
benefits 

- improving the overall readability of the document.  

All these recommendations have been taken into account and relevant sections of the 
report revised accordingly. 

2. 

PROBLEM DEFINITION 

Policy Context/Background 

Accidents often have serious, even devastating, consequences: workers are killed; the 
public  is  exposed  to  chemicals  resulting  in  immediate  injury  or  long-term  health 
impacts;  rivers  and  underground  water  sources  are  polluted,  impacting  drinking 
water;  facilities  and  nearby  developments  suffer  significant  damage,  sometimes 
resulting  in  closure  of  companies.  Some  well-known  major  accidents  like  Seveso, 
Bhopal, Schweizerhalle, Enschede, Toulouse and Buncefield have taken many lives 
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  legislation  addresses  accident  prevention  and  preparedness  and  lessons 
learned  from  such  accidents.  The  current  Seveso  II  Directive  was  adopted  in  1996 
and amended by Directive 2003/105/EC (10). Its main objective is to prevent 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  main  requirements  are  that  all 
operators falling under the Directive must notify their activities and establish a major 
accident prevention policy. In addition, operators of 'upper tier' establishments have 
to  establish  a  safety  report,  and  put  in  place  a  safety  management  system  and  an 
internal emergency plan. There are also obligations on public authorities relating to, 
inter  alia,  external  emergency  plans  and  public  information  on  safety  measures  for 
upper-tier establishments, domino effects, land-use planning, accident reporting and 
inspections.  Further  background  information  is  provided  in  Annex  IV  of  this 
document. The frequency of major accidents has fallen by some 20% between 2000 
and 20081. This downward trend suggests that the Directive is meeting its objectives. 
Furthermore,  the  fact  that  the  goal-setting  Seveso  approach  has  been  copied 
worldwide attests to its success2. 

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,  and  taking 
into  account  implementation  reports  from  Member  States  that  identified  some 
deficiencies, it was decided to undertake a wider review since the basic structure of 

1  Trend  of  reported  Seveso  accidents  in  the  last  three  reporting  periods  per  1000  establishments:  2000-02:  >10,    03-05:  ~9,:  06-08:  ~  8 
(Seveso Implementation report 2006-2008).  
2 Examples: UNECE Convention on the Transboundary Effects of Industrial Accidents, UNEP Flexible Framework for addressing Chemical 
Accident Prevention and Preparedness 

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the Directive  and its main requirements  have remained  essentially  unchanged  since 
its  adoption.  This  review  has  focussed  on  the  effective  implementation  of  the 
Directive  and  on  whether  any  improvements  should  be  made  in  this  regard.  The 
review has shown that the Directive has been instrumental in reducing the likelihood 
and  consequences  of  chemical  accidents  thereby  leading  to  better  protection  of 
human health, the environment, and economic resources. It has also confirmed that 
overall  the  existing  provisions  are  fit  for  purpose  and  that  no  major  changes  are 
required.  

However, the review also confirmed that in a number of areas 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.  This  impact  assessment  focuses  only  on 
those  elements  of  the  existing  Directive  identified  as  warranting  consideration  for 
possible  amendment  and,  in  view  of  the  above,  mainly  on  the  cost  implications  of 
such additional action.  

In  all  the  areas  considered,  action  at  Community  level  is  needed  to  ensure  that 
existing  high  levels  of  protection  of  human  heath  and  the  environment  are 
maintained,  to  promote  greater  harmonisation  in  implementation  and  thereby  avoid 
significantly  different  levels  of  protection  in  the  Member  States  and  possible 
distortions  to  competition  that  could  result.  The  subsidiarity  principle  is  respected 
since the aim is to continue the existing approach of laying down harmonised goals 
and  objectives,  but  leave  detailed  practical  implementation  to  be  determined  by 
Member States since this can be done more effectively at national level.  

Industry,  competent  authorities  and  the  public  will  potentially  be  affected.  Seveso 
plants  are  evenly  spread  among  Member  States.  Dangerous  substances  are  widely 
used in many industries with the main sectors being chemicals manufacture, energy 
storage, and wholesale and retail storage (see Annex IV).  

As  regards  SMEs,  the  Directive  is  targeted  at  establishments  with  a  high  major-
accident hazard potential due to the large quantities of dangerous substances present. 
There is not necessarily a correlation between the quantities of dangerous substances 
present at an establishment and the size of the operator. However, storage sites are 
often SMEs as they are not labour-intensive. Any SMEs falling within the scope of 
the Directive have to adhere to the basic rules. However where possible due account 
has  been  taken  of  the  need  for  implementation  and  control  measures  to  be 
proportionate  to  risk,  size  and  management  structure,  and  this  approach  will  be 
maintained in the new Directive. 

The issues/problems that require actions  

As noted above, the key issue that requires action is the alignment of Annex I to the 
new chemicals legislation and the impact on the scope of the Directive (policy issue 
1). Related to that issue are possible other technical amendments to Annex I (policy 
issue 2) and the procedures for adapting Annex I in the future (policy issue 3). The 
remaining issues are less major. The most significant of these relate to information to 
the  public  and  information  management  systems  (policy  issue  4)  and  land-use 

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planning (policy issue 5), where experience of implementation to date indicates that 
some opportunities for improvements or new requirements may exist. The other issue 
relates  to  relatively  minor  technical  adaptations  to  a  number  of  detailed  provisions 
which could usefully be clarified or updated (policy issue 6). This is reflected in the 
level  of  analysis  provided,  with  the  assessment  focussing  mainly  on  the  most 
important issues in terms of possible impacts.  

2.1. 

Policy issue 1: Alignment of Annex I to CLP 

The Directive has to be amended due to changes in the EU system of classification of 
dangerous substances.  

The Directive has links and interactions with Regulation (EC) No 1907/2006 of the 
European  Parliament  and  of  the  Council  of  18  December  2006  concerning  the 
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)(10) 
and  Regulation  (EC)  No.  1272/2008  on  classification,  labelling  and  packaging  of 
substances and mixtures (CLP) (11)3.  

In brief, REACH is the system at EU level for registering, evaluating and authorising 
dangerous  substances  and  it  provides,  amongst  other  things,  information  about  the 
properties of dangerous substances. CLP uses information from REACH to classify 
substances  under  various  categories  of  hazard,  implementing  within  the  EU  the 
internationally- accepted GHS (Globally Harmonized System for Classification and 
Labelling of Chemicals), developed at UN level. EU 

The scope of the Seveso II Directive is defined by its Annex I listing substances (and 
mixtures thereof) and the relevant threshold quantities above which an establishment 
falls under the Directive. Part 1 of Annex I lists 'named substances'. Part 2 of Annex I 
lists 10 selected categories of hazard under the previous EU classification system as 
set  out  in  Directives  67/548/EEC  (Dangerous  Substances  Directive  -  DSD)  and 
1999/45/EC  (Dangerous  Preparations  Directive  -  DPD),  including  the  categories 
Very Toxic, Toxic, Oxidising, Explosive, Extremely Flammable, Highly Flammable, 
Flammable,  Dangerous  to  the  Environment,  and  further  hazards.  All  substances 
falling  within  these  hazard  classification  categories  automatically  fall  within  the 
SevesoII Directive's scope. This previous classification system will be repealed. The 
references  will  be  repealed  by  the  CLP  Regulation,  which  entered  into  force  20 
January  2009,  and  applies  to  all  substances  and  mixtures  on  the  EU  market. 
Substances  can  already  be  classified  under  the  new  system  as  from  1  December 
2010,  but  this  does  not  become  mandatory  until  1  June  2015,  when  the  CLP  rules 
become  definitive.  In  amendments  to  downstream  legislation  like  the  Seveso  II 
Directive, references to the old system have to be replaced by that date. To guarantee 
a  robust,  consistent  and  sustainable  approach,  all  relevant  EU  legislation  will  be 
converted to the new rules. Specific adjustments to other downstream legislation are 
also taking place, for example, by Directive 2008/112/EC (an omnibus directive on 
cosmetics,  toys,  VOC,  solvents,  some  waste  streams)  and  Regulation  (EC)  No 
1336/2008 relating to detergents.  

3 Many provisions of CLP are closely linked to provisions under Regulation 1907/2006 on the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH). However, as CLP is the new classification system for all chemicals and all downstream legislation like 
Seveso and REACH, Seveso will only refer to CLP and not to REACH.  

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In  the  future,  as  REACH  will  keep  generating  new  information  about  substances, 
additional  substances  may  be  classified  under  CLP,  which  would  in  turn 
automatically affect the scope of the Directive. 

The  issue  is  therefore  to  replace  the  old  hazard  classification  categories  by  1  June 
2015 by the new CLP categories. As explained above, it would be unworkable and 
make no sense to continue to refer to the old system once it no longer exists.  

A  change  to  the  new  system  can  not  simply  be  done  by  an  automatic  change  of 
reference  to  the  new  system.    A  downstream  legislation  study  (12),  accompanying 
the  impact  assessment  for  the  CLP  Regulation  confirmed  this.  As  a  result,  the 
Commission concluded already in its proposal (13) for the CLP Regulation that for 
the  Seveso  II  Directive  no  simple  one-to  one  "translation"  from  the  old  to  the  new 
categories  is  possible  and  that  the  CLP  Regulation  will  have  a  substantial  impact. 
Therefore,  necessary  measures  would  have  to  be  tailor-made  and  introduced  in  a 
separate amendment to the Directive. Against this background, "do-nothing" is not a 
valid option and will not be pursued further. 

2.2. 

 Policy issue 2: Other technical amendments to Annex I 

The Annex I review presents an opportunity to consider whether other amendments 
to  its  scope  are  necessary.  The  first  driver  for  such  amendments  is  lessons  learned 
from past accidents. The review process has not identified the need to modify Annex 
I due to accidents with specific substances. The second driver is to adapt the scope 
due  to  technical  progress,  especially  concerning  new  technologies,  new  energy 
carriers,  emerging  risks,  -  and  also  whether  specific  categories  or  substances  are 
appropriately  covered  by  the  scope  of  Seveso.  The  following  issues  have  been 
identified:  Carbon  dioxide  (CO2,),  on  which  there  were  concerns  from  some 
competent  authorities  about  possible  emerging  risks  in  the  filed  of  carbon  capture 
and storage; hydrogen (H2), on which industry expressed concern about the impact of 
the Directive on possible developments in the use of the substance as a major energy 
carrier,  and  three  substances/products  concerned  by  CLP  re-classification,  namely 
heavy fuel oil, aerosols and sodium hypochlorite.  

2.3. 

Policy issue 3: Procedures for adapting Annex I in the future  

This issue is linked to policy issue 1. It is difficult to judge with certainty at this stage 
what  will  be  the  impacts  of  the  initial  alignment  of  Annex  I,  and  in  particular  its 
automatic adaptation to future changes in classifications of substances and mixtures 
over time in the future as the CLP is gradually applied. This could lead to substances 
and  possibly  mixtures,  due  to  their  complex  classification  under  CLP,  being 
inappropriately  included  or  excluded  from  the  Directive  irrespective  of  whether  or 
not they present a major-accident hazard. 

The only correction mechanism under the present Directive is very limited. Member 
States may grant a lowering of the safety report information requirements for upper-
tier  establishments  when  it  can  be  demonstrated,  on  the  basis  of  harmonised  EU 
criteria  (as  laid  down  in  Commission  Decision  98/433/EC(14)),  that  the  substance 
does  not present  a major-accident  hazard. This derogation provision, which is  little 
used, is inadequate as a means to deal with the situation at EU level when it can be 
shown  that  a  substance  does  not  have  any  major-accident  hazard  potential  and 

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therefore  should  not  be  included  within  the  scope  of  the  Directive.  There  is  no 
counterpart  provision  such  as  a  safeguard  clause  to  deal  with  substances  that, 
notwithstanding  their  hazard  classification,  should  be  included  in  Annex  I  because 
they have a major accident hazard potential.  

Furthermore  the  current  procedure  for  amendments  to  Annex  I,  which  have  to  be 
adopted  via  the  normal  legislative  procedure  (co-decision),  does  not  facilitate  the 
necessary adaptations to deal with these kinds of situation. 

2.4. 

Policy  issue  4:  Information  to  the  public  and  information  management 
systems, including reporting 

The Directive's current requirements in this area are summarised in Annex V of this 
report.  It  is  important  that  the  public  is  informed  about  major  accident  issues.  The 
public  has  a  right  to  such  information  (subject  to  appropriate  confidentiality 
safeguards);  and  information  about  specific  sites  is  very  important  for  increasing 
awareness  and  ability  to  respond  appropriately  should  an  accident  take  place.  The 
Directive  requires  that  that  information  is  both  actively  made  available  to  affected 
members of the public without their having to request it and also kept permanently 
available  for  the  public.  It  is  silent  on  what  form  of  communication  is  used  and 
whether it is the operator or the competent authority responsible. 

The  latest  three-yearly  implementation  reports  from  Member  States  indicate  that 
there are uneven implementation and practices across Member States relating to the 
provision and use of information to potentially affected groups as well as the public 
more  generally.  Overall,  during  the  period  2004  to  2008  the  public  received 
information  for  about  only  around  80%  of  establishments  and  it  is  unclear  how 
frequently this was done. The two studies assessing the effectiveness of the Directive 
confirmed the shortcomings in performance and noted that there are information gaps 
(for example as regards external emergency plans) and a lack of monitoring that the 
information is being supplied. Furthermore the provisions pre-date and are not in line 
with  Directives  2003/4/EC  and  2003/35/EC  implementing  the  Aarhus  Convention. 
Member State reporting about Seveso plants and major accidents are also relevant in 
this context as these also contain information of interest to the public. At the same 
time  there  is  a  need  to  take  into  account  the  Directive's  provisions  as  regards  the 
confidentiality  of  such  information,  including  intellectual  property  rights,  and 
ensuring 
terrorist  attacks. 
Furthermore there is also the issue of whether more non-technical information would 
be helpful. For example, there is broad agreement that the safety report is not a very 
suitable way of informing the public; a non-technical summary in layperson's terms 
might be more appropriate. 

information  will  not  facilitate  possible 

that 

this 

In  the  light  of  the  continued  advances  in  information  management  systems  and 
procedures such as the Internet, which enable frequent updating of information, there 
is  also  a  need  to  consider  how  management  of  the  information  can  be  improved  to 
ensure that the necessary information is made /kept available to the public.  

Overall,  most  Member  States  operate  databases  for  internal  use  in  the  relevant 
competent authorities. These databases might include site-specific information from 
the  operator,  but  generally  there  is  limited  or  no  public  access.  Moreover  these 
databases  generally  do  not  contain  the  safety  information  that  has  to  be  made 

EN 

12 

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available to the public pursuant to Annex V of the Directive, since in most Member 
States responsibility for informing the public lies with the operator. There is thus a 
potential gap in collecting such information and ensuring that it is made available to 
the public. 

All  this  suggests  that  there  is  a  need  to  improve  both  the  level  and  quality  of  the 
information provided to the public, but also the way information is managed so that it 
can be made available in an efficient and streamlined way.  

2.5. 

Policy issue 5: Land-use planning  

Article  12  of  the  Directive  provides  that  Member  States  shall  control  the  siting  of 
new establishments, modifications to existing establishments and new developments 
in  the  vicinity  of  existing  Seveso  sites  where  this  could  increase  the  risk  or 
consequences of a major accident.  

Experience  to  date  indicates  that  the  current  provisions  are  working  satisfactorily, 
although the number of cases where the provisions take effect are limited. However 
although  the  existing  provisions  appear  to  be  effective  and  are  being  properly 
implemented, they do not make it clear that they apply to both upper- and lower-tier 
establishments and lack any clear reference to the need to protect the environment, 
which  could  potentially  give  rise  to  some  inconsistencies  in  implementation.  In 
addition,  there  is  a  risk  that  in  some  cases  the  land  use  planning  procedures  under 
Article 12 may overlap with those under the EIA and SEA Directives.  

Furthermore, although there have been no calls for major changes to the Directive in 
this  regard,  since  the  current  provisions  (controls  on  inappropriate  land  use,  in 
particular controlling the siting of new establishments and ensuring in the long-term 
appropriate  safety  distances)  have  remained  unchanged  for  a  long  time,  it  seems 
appropriate  to  consider  whether  the  time  is  ripe  to  extend  the  requirements.  For 
example,,  the  issue  of  existing  establishments  that  are  already  situated  in  the 
immediate  vicinity  of  residential  areas  and  other  areas  frequented  by  the  public, 
which is being addressed at national level by some Member States, is not covered at 
present.  

2.6. 

Policy issue 6: Other areas where implementation could be improved  

The  various  issues  can  be  grouped  under  two  broad  headings:  the  need  for  closer 
integration  of  information  and  procedural  requirements;  and  the  need  to  update  or 
clarify certain provisions to facilitate implementation and enforceability. 

A) Closer coordination, Integration of information and procedures, etc 

implementation,  conflicting  or  overlapping 

The  review  process  identified  some  concerns  about  shortcomings  in  coordination 
between  authorities,  both  within  and  between  Member  States  that  can  lead  to 
requirements  and 
inconsistent 
unnecessary  administrative  burdens  for  operators.  Specific  areas  identified  include 
inspections under the Directive and under other legislation; and possibly overlapping 
information and procedural requirements with other legislation applicable to Seveso 
establishments. There was widespread recognition of the value of existing activities 
undertaken to promote more consistent implementation of the Directive. There was 

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strong support for these to be maintained and further developed, such as support for 
inspections  through  exchanges  of  information  and  best  practices,  and  cooperation 
between  the  Commission  and  Member  States  on  implementation  issues,  including 
where  appropriate,  the  development  of  further  guidance.  Further  details  on  these 
issues are set out in Annex VI.  

B) Other areas where improvements are needed 

The review also identified a number of areas where the existing provisions lack the 
necessary clarity or precision to ensure greater consistency in implementation and its 
effectiveness.  The  issues  include:  the  lack  of  any  reference  to  the  use  of  safety 
performance indicators; the need to take into account non-Seveso establishments in 
the context of domino effects;  the need to clarify that underground gas storage sites 
fall  within  the  Directive's  scope;  the  need  for  clearer  references  to  environmental 
aspects  in  the  detailed  provisions  given  that  the  aims  of  the  Directive  include 
protection  of  the  environment;  possible  delays  in  the  completion  of  external 
emergency plans due to the lack of any clear deadline; and, as regards the reporting 
of  accidents,  the  threshold  for  reporting  results  in  potentially  important  accidents 
going  unreported  and  possible  delays  in  reporting  due  to  the  lack  of  any  specific 
deadline.  The  provisions  in  relation  to  safety  management  requirements  for  lower-
tier  establishments  (and  in  particular  the  relationship  between  an  operator’s  major-
accident prevention policy and safety management systems) are also unclear, leading 
to widely differing approaches in the Member States. Further details on these issues 
can also be found in Annex VI. 

3.  OBJECTIVES 

The  overall  aim  remains  the  prevention  of  major  accidents  and  mitigation  of  their 
consequences by maintaining and further improving existing levels of protection for 
human  health  and  the  environment.  In  line  with  the  Commission's  strategic 
objectives and better regulation principles, this should be achieved by improving the 
regulatory provisions to make them more effective and efficient, and where possible 
reducing unnecessary administrative burdens for Member States and industry. At the 
same  time  the  Directive  should  be  clear,  coherent  and  easy  to  understand  to  help 
increase consistency of implementation. 

In  order  to  achieve  the  general  objectives  and  address  the  different  issues  and 
problems described above, the following specific objectives have been identified: 

•  The main aim is to align Annex I to the CLP while maintaining existing levels of 

protection. 

•  The  other  aims  are  to  clarify  certain  provisions  to  improve  implementation  and 
enforceability, while maintaining the existing hazards-based two-tier approach of 
the  Directive  and  its  goal-setting  nature.  Other  provisions  should  be  updated  to 
take  account  of  technological  and  regulatory  developments  since  the  current 
Directive's adoption. 

•  Where  possible  requirements  should  be  streamlined  or  simplified  to  reduce  the 
for  operators  and  competent  authorities  without 

administrative  burden 
compromising safety. 

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4.  POLICY OPTIONS 

A  detailed  description  of  the  options  examined  is  included  in  Annex  II.  With  the 
exception of policy issue 1, the baseline scenario is business as usual, i.e. no changes 
to the Directive's existing provisions. 

4.1. 

Policy issue 1: Alignment of Annex I to the CLP 

The alignment to the CLP is straightforward for all categories of hazard (see Annex 
VII) except for toxicity. The options considered therefore only differ in the way they 
address toxicity. 

CLP  aligned  legislation  must  refer  to  the  new  categories  Acute  Toxic  1’,  ‘Acute 
Toxic  2’  and  ‘Acute  Toxic  3’  ,  but  these  do  not  completely  correspond  to  the  old 
categories ‘toxic ‘(T) and ‘very toxic’ (T+) which have different cut-off values for  
lethal  doses.  This  implies  changes  in  classification  that  could  significantly  increase 
or  decrease  the  Directive’s  scope.  Moreover  the  effects  are  further  complicated 
because the new toxicity categories are divided into the three exposure routes: oral, 
dermal and inhalation, and the classification of individual substances in accordance 
with this differentiation is often not known. 

In line with the objective of this alignment exercise, options with high impact on the 
scope or complexity of the directive were discarded at an early stage (See Annex II). 
In  particular  the  individual  screening  of  each  substance,  option  A,  would  be 
complicated to implement, both for business and for authorities, and option B would 
strongly reduce the scope.  

As  the  new  category  'Acute  Toxic  1’  is  included  in  ‘very  toxic’  (T+)  and  ‘Acute 
Toxic 2’ is mainly included in the old category ‘toxic ‘(T),  the difference between 
the  options  considered  is  for  which  exposure  routes  the  old  category  ‘toxic  ‘(T)  is 
aligned to ‘Acute Toxic 3’: 

Where marked by "X" old category ‘Toxic ‘(T) is aligned to new 
category ‘Acute Toxic 3’ 

Oral 

Dermal 

Inhalation 

Vapour  

Aerosol  

Gas 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

Option 

C 

D 

E 

E* 

Whichever alignment option is chosen, there is a degree of uncertainty of the impact 
over  time.  The  baseline  will  move  in  the  future  because  as  REACH  generates  new 

EN 

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information  in  a  dynamic  way,  additional  substances  may  be  classified  under  CLP 
and  thus  automatically  fall  within  the  scope  of  the  Directive.  Potential  correction 
measures are therefore necessary and are addressed in Policy issue 3. 

4.2. 

Policy issue 2: Other technical amendments to Annex I 

The policy options presented below deal with different issues where adaptation of the 
scope to technical progress may be appropriate, with alternative options as indicated. 
The  first  issue  arose  in  the  context  of  CCS  (Carbon  Capture  and  Storage) 
technologies,  the  second  about  energy  carriers  and  the  last  three  relate  to  the  first 
examples of specific substances/products directly affected by the new classification 
system. 

•  Possible inclusion of CO2: This option has been discarded given the early stage of 
development  of  Carbon  Capture  and  Storage  technologies  and  that  further 
experience  is  needed  to  better  understand  any  potential  risks.  At  the  same  time, 
Directive  2009/31/EC  on  the  geological  storage  of  CO2  establishes  a  legal 
framework for the environmentally safe geological storage of CO2. 

•  Hydrogen:  a)  do  nothing  (retain  in  the  list  of  named  substances  requiring 
lower/upper-tier 
thresholds  of  5/50 
individual 
establishments);  or  b)    grant  an  alleviation  by  doubling  the  lower-tier  threshold 
and classifying the substance according to its flammability) 

treatment  with 

tonnes  for 

•  Heavy fuel oil: a) do nothing (accept effect of possible re-classification as toxic to 
the  aquatic  environment  with  thresholds  of  200/500  tonnes  ();  or  b)  avoid  the 
possible  effect  by  giving  an  exemption  as  for  other  petroleum  products  by 
including it in the list of named substances with thresholds of 2500/25000 tonnes. 
•  Flammable Aerosols: a) CLP approximation proposal of 150/500 tons thresholds 
to cover approximately existing sites; or b) higher thresholds of 1300/5200 tonnes 
•  Sodium hypochlorite: a) do nothing (CLP for mixtures will apply, with thresholds 
of 100/200 tonnes); or b) exemptions (named substance with increased thresholds 
200/500 tonnes or a derogation for packaged products in limited quantities (inner 
pack up to 5 litres and combination pack up to 30kg).  

4.3. 

Policy issue 3: Procedures for adapting Annex I in the future 

The uncertainties caused by the new classification system suggest a need for flexible 
tools to be able to adapt Annex I as necessary via delegated acts. A precondition for 
using  such  tools  would  be  to  have  clear  criteria.  The  basic  act  would  include  the 
general criteria with detailed harmonised criteria to be adopted  by  the Commission 
through  delegated  acts.  The  latter  would  be  developed  in  parallel  to  the  legislative 
procedure in order to be ready for adoption immediately after the entry into force of 
the  new  directive.  This  would  thus  allow  ample  time  for  adopting  derogation 
decisions before 1 June 2015, when CLP rules become definitive. 

Options: 

(a) Do nothing. Any amendments to Annex I would continue to be via an amendment 
to  the  Directive  adopted  by  ordinary  legislative  procedure.  The  existing  derogation 
rule,  allowing  Member  States  to  grant  establishment-specific  exemptions  to  upper-
tier  establishments  based  on  the  existing  harmonised  criteria  limited  to  information 

EN 

16 

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requirements  related  to  safety  reports  for  upper-tier  establishments,  would  be  left 
unchanged. 

(b) Extend the scope of the existing derogation rule based on the current harmonised 
criteria  laid  down  in  Commission  Decision  98/433/EC  to  allow  Member  States  to 
grant  establishment-specific  exemptions  to  upper-tier  establishments  covering 
requirements  such  as  those  relating  to  safety  reports,  emergency  plans  and 
information to the public. 

(c)  Allow  EU-wide  substance  derogations  from  some  or  all  Seveso  requirements 
using harmonised criteria by further developing the existing harmonised criteria such 
as points 1 (criterion: physical form, properties) and 4 (criterion: classification)  . The 
derogations,  by  delegated  acts,  could  take  the  form  of  reduced  requirements  or 
complete exemption.  

(d):  General  establishment-specific  derogations  at  Member  State  level  using 
harmonised  criteria  based  on  points  2  (criterion:  containment  and  quantities)  and  3 
(criterion: location and quantities) of the existing harmonised criteria. The derogation 
would  apply  to  all  qualifying  establishments  and  could  take  the  form  of  reduced 
requirements or complete exemption. 

(e)  Introduce  a  'Safeguard  clause'  as  counterpart  to  options  c)  and  d),  to  deal  with 
situations  such  as  those  where,  notwithstanding  their  falling  outside  the  Directive's 
scope  due  classification  under  CLP  rules,  a  substance  presents  a  major  accident 
hazard potential and should be covered. 

4.4. 

Policy issue 4: Information to the public and information management systems 
including reporting 

These policy options address possible improvements as to how information of better 
quality can be made available more efficiently and effectively to the public. 

A) Options for type of information provided 

(a) Unchanged policy. The information would be as currently required by Annex V 
of the Directive. The means by which the information is made available, and whether 
it is the operator or the competent authority responsible, would remain a matter for 
the Member States. 

(b)  Annex  V  information  made  available  on-line.(c)  Annex  V  information  plus 
additional information for all establishments made available online as follows: 

- for all  establishments: basic information about each establishment (name, address 
and information about its activities);  

- for upper-tier establishments, a summary of the main major accident scenarios and  
key information from the external emergency plan in case of an accident. 

(d)  Option  (c)  plus  non-technical  summaries  of  the  safety  report  and  external 
emergency plan made available online. 

EN 

17 

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B) Options for information management 

(a)  Unchanged  policy.  Existing  arrangements  would  continue  with  Member  States 
deciding whether they operate databases and whether they allow public access. 

(b) Member States databases. Member States would be required to operate databases 
with  public  access  to  Annex  V  information.  Most  Member  States  already  operate 
something  similar  though  there  might  not  be  public  access  to  information  about 
individual sites.  

(c)  Central  EU-wide  database  with  links  to  Member  States  websites.  A  simple 
website with links to documents either directly uploaded onto an adapted version of 
the  database  managed  by  the  Commission  for  the  purposes  of  Article  19.1a  of  the 
Directive 
the 
information/documents.  

to  Member  States'  websites  with 

(SPIRS)  or 

links 

(d) Central EU database, fully integrated.  

4.5. 

Policy issue 5: Land-use planning  

The policy options are as follows: 

(a) Unchanged policy. The current system would be retained with no changes. 

(b) Minor modifications to Article 12 to clarify that the requirements apply to both 
upper- and lower-tier establishments and are aimed at the protection of both man and 
environment  (  which  currently  is  not  expressly  mentioned),  including  taking  into 
account  areas  of  particular  natural  sensitivity;  and  to  make  reference  to  procedures 
under the Environmental Impact Assessment Directive and similar legislation.  

(c) Extension of provisions in full to all upper-tier plants, including existing plants.  

4.6. 

Policy issue 6: clarifications to facilitate effective implementation 

The overall aim is to facilitate effective implementation and enforceability and at the 
same  time  where  possible  to  introduce  streamlining  and  simplification  to  reduce 
administrative  burdens.  The  option  components,  which  are  explained  in  Annex  VI, 
fall under the following headings: 

A) Closer Coordination/integration (inspections, etc.) and 
B)  Other  areas  where  improvements  are  needed  (clarifications,  use  of  safety 
performance indicators, Safety Management System required or not for Lower Tier 
Sites)  

5. 

ANALYSIS OF IMPACTS  

Most affected by all impacts assessed will be the operators of Seveso plants, but also 
competent authorities. SMEs represent a significant percentage of operators and are 

EN 

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much  more  sensitive  to  cost  impacts.  Especially  for  micro-enterprises,  for  example 
for  storage  or  surface  treatment  sites,  or  for  sites  with  variable  inventories,  costs 
represent  a  much  higher  impact  than  for  large  companies  (see  also  section  6.8  and 
Annex VIII). 

Policy  issues  1  to  3  have  an  impact  on  the  scope,  meaning  that  companies  would 
have  to  comply  newly  with  the  provisions  of  the  Directive,  or  that  Seveso 
establishments would not any more be subject to the Directive. The key indicator to 
assess this impact on scope is the change in the number of establishments.  

This and other impacts are predominantly presented as yearly costs for industry and 
authorities.  The  basic  cost  assumptions  and  limitations  on  which  this  analysis  is 
based are set out in Annex VIII. It should be noted that, unless indicated otherwise, 
the  estimated  costs  relate  to  net  additional  administrative  costs  for  industry  and 
authorities.  It  is  not  possible  to  quantify  costs  related  to  physical  compliance 
measures for establishments that will be directly affected by changes to the scope of 
the  Directive  (this  is  discussed  in  further  detail  in  section  5.1.4,  relating  to  policy 
issue 1, which is main issue where the question is relevant). The impact estimates are 
limited  to  impacts  arising  from  the  Directive  only.  It  would  be  disproportionate  to 
extend the analysis to any stricter requirements in Member States.  

Social impacts in terms of human health and employment are also assessed, but in a 
qualitative  way  (in  the  absence  of  data,  it  is  not  possible  to  quantify  the  impact  on 
employment levels (see also section 6.9)). Where possible, the expected benefits of 
the options in terms of simplification and reduction in administrative costs are also 
assessed in a qualitative way (see also section 6.10). 

5.1. 

Policy issue 1: Alignment of Annex I to the CLP 

5.1.1.  CLP adjustment 

Whatever option is chosen, all Seveso operators have to review their inventories in 
the  light  of  the  new  Annex  I  and  provide  information  about  the  CLP  adjusted 
substances,  mixtures  or  categories  to  the  authorities.  For  all  Seveso  establishments 
and  for  all  hazards,  the  total  one-off  Seveso-related  CLP  adjustment  costs  for 
reviewing inventories have been estimated for operators at around 1.7 Million EUR 
(7.6 Million annualised over 5 years at 4%), which represents an average of around 
200  EUR  per  establishment,  per  year.  In  addition  to  the  costs  for  industry,  the 
adjustment costs for authorities would be around 400.000 EUR per year (1.8 Million 
over 5 years).  

To put these costs in context, the administrative costs of the Seveso II Directive for 
industry have been estimated by the administrative burdens study to be about EUR 
52  million  per  year.  The  second  COWI  impact  assessment  study  has  estimated  the 
total administrative costs to both industry and authorities to be at least of the order of 
100 million EUR. 

5.1.2.  Mixtures  

The CLP Regulation changes rules for the classification of mixtures in comparison to 
the current rules for preparations under the Dangerous Preparations Directive (DPD) 

EN 

19 

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199/45/EC  to  which  Seveso  refers.  In  2006,  the  CLP  Impact  Assessment  on 
downstream  legislation  (12)  mentioned  concerns  that  combining  the  CLP  mixture 
approach with the Seveso volume-based approach might lead to a significant increase 
in the scope of the Seveso Directive.  

A  study  conducted  by  the  UK  HSE,  and  discussed  by  the  multi-stakeholder 
Technical Working Group, gave examples of both increases and decreases in scope 
and  concluded  that  the  CLP  mixture  classification  procedure  would  in  practice  not 
result in an increase in scope of Seveso, but rather may potentially reduce the scope 
of Seveso for some establishments. However, as for the whole issue of alignment to 
the  CLP  Regulation,  there  remains  some  uncertainty  concerning  mixtures  so 
unwanted effects cannot be excluded. This confirms the need for flexibility tools as 
considered under issue 3. 

5.1.3.  Costs and benefits of Option (C) to (E*):  

For the reasons already stated, an unchanged policy "0" is not a valid option. 

The  necessary  switch  to  the  new  system  with  different  Acute  Toxicity  Categories 
makes  it  inevitable  that  additional  substances  would  be  included  within  the 
Directive's scope or excluded. Depending on the choice of option this could lead to 
more or fewer establishments covered.  

The  data  sources,  the  methodology  and  assumptions  for  estimating  the  number  of 
possibly affected establishments, based on the classification of toxic substances, are 
explained in Annex VII. A more detailed assessment, including a list of substances 
potentially affected and figures for lower tier and upper tier sites, is included in the 
final report of the impact assessment study. 

The main question under the options (C) to (E*) is how many establishments will no 
longer  fall  under  the  Directive,  and  how  many  will  be  newly  included  within  the 
scope. Firstly, for all options the old 'Very Toxic' category has been aligned to 'Acute 
Toxic 1'. This leads for all options to a reduction estimated at 314 sites as (1) some 
substances currently captured by 'Very Toxic' will not be captured by 'Acute Toxic 1' 
and therefore the inventory of these sites falls under the Seveso Threshold for 'Acute 
Toxic 1' (5 tonnes), and (2) the inventory of these sites for 'Acute Toxic 1' and 'Acute 
Toxic 2' does not increase sufficiently to reach the applicable Seveso Threshold (50 
tonnes). Secondly, the options differ concerning the alignment from 'Toxic' to 'Acute 
Toxic 2 and 3 ' between -91 and +342 sites. In detail, the impact of the options C to 
E* on the number of Seveso establishments, is as follows:  

Option 

Change of number of establishments 

a) T+ 
alignment 

b) T alignment  
excluded sites 

b) T alignment 
newly 
included sites 

Net-effect 

% Change of 
establishment
s 

C 

D 

E 

E* 

-314 

-314 

-314 

-314 

-10 

- 

-101 

-91 

+131 

+342 

+10 

+221 

-193 

+28 

-405 

-184 

-2% 

+0.3% 

-4.2% 

-1.9% 

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Overall, the impact is quite limited. Although all options are intended to be close to 
the  current  scope,  the  number  of  establishments  affected  by  the  change  in 
classification  system  replacement  ranges  from  a  minimum  of  around  400  to  a 
maximum of 650 firms. A maximum of 350 new sites could be covered, and around 
400 could fall out of scope.  

The  cost  analysis  has  identified  two  different  types  of  costs  building  upon 
information presented in Annex VIII, as follows: 

(1) 

(2) 

For  establishments  affected  by 
the  annual 
administrative adaptation costs range between around 1.7 Million EUR to 2.9 
Million EUR (for more differentiated exposure routes, as in option C).  

the  alignment  options, 

Costs (or savings) related directly to the change in number of establishments 
falling  within  the  scope  range  from  savings  varying  between  2.5  and  3.3 
Million  EUR,  to  costs  for  new  sites  varying  between  0.2  and  5.7  Million 
EUR. 

These  alignment  option-related  administrative  costs  for  industry  are  summarised 
below (for more information and explanation on costs see Annex VIII): 

Option 

General 
adaptation (1) 

Change in scope costs (2) 

a) T+ 
alignment 

b) T alignment 
excluded sites 

b) T alignment  
newly included sites 

C 

D 

E 

E* 

2.9  

1.7  

2 

2 

-2.5 

-2.5 

-2.5 

-2.5 

-0.1 

- 

-0.8 

-0.8 

+2.2 

+5.7 

+0.2 

+3.7 

The above figures take into account that the cost savings for an establishment falling 
outside the scope of the Directive will be lower and not offset the additional costs for 
a new establishment since the former will have already incurred costs.  

The  change  of  scope  will  also  have  related  cost  impacts  for  authorities  and  are 
assumed to be around 10% of the costs to industry. 

5.1.4.  Non-administrative compliance costs 

It is very difficult to estimate non-administrative compliance costs for establishments 
that  would  fall  under  the  Directive.  The  Directive  is  goal-setting  in  nature 
establishing  a  process  for  operators  to  demonstrate  safety,  mainly  through  various 
information  obligations.    These  entail  administrative  costs.  There  are  no  specific 
requirements  in  relation  to  physical  measures  to  be  taken.  These  are  a  matter  for 
Member States to determine in order to ensure that all necessary measures have been 
taken to prevent accidents. 

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Such physical compliance costs are site- or substance- specific and are expected to be 
significantly impacted by other legislation such as that on worker protection, product 
safety,  industrial  emissions,  etc.  They  will  also  depend  on  the  policy  approach  in 
each Member State. 

 The  types  of  investment  needed  in  physical  measures  could  include  equipment  to 
monitor processes and facilities; storage capacity and containment infrastructure. A 
responsible operator would normally be making such investments anyway as part of 
their  normal  business  activity.  In  doing  so,  they  will  also  consider  the  risk  of 
accidents  and  the  costs  of  these  (production  losses,  clean-up  costs,  compensation 
costs,  etc).  Whether  they  alter  their  behaviour,  for  example  by  switching  to  safer 
chemicals,  reducing  stocks  to  fall  out  of  scope,  relocation  outside  EU,  etc,  will 
depend  on  the  costs  of  such  changes  of  behaviour  compared  with  the  costs  of 
compliance and how these impact on the overall costs of doing business.   

See Annex VIII for further details. 

5.1.5.  Other impacts 

Options  C,  E  and  E*  all  lead  to  a  decrease  in  scope  which  could  lead  to  a  small 
decrease in protection levels for human health and the environment. Option D could 
lead to a slight increase. This could include a positive impact on worker protection. 
There  could also be an effect on  employment levels  in  line with the  low  economic 
effects  of  the  option  arising  from  the  slight  increase  in  the  Directive's  scope. 
However it is difficult to quantify these. Option E* would maintain a high level of 
protection  taking  into  account  the  most  likely  and  relevant  exposure  routes  in  the 
event of a major accident. 

As  regards  simplification,  the  decrease  in  scope  arising  from  options  C,  E  and  E* 
would lead to a reduction in administrative costs, but they would be complicated to 
apply in practice. D would be clear and simple to apply, which could offset some of 
the  additional  administrative  costs  arising  from  the  increase  in  scope  (see  also 
comparison of the options in section 6.1).  

5.2. 

Policy issue 2: Other technical amendments to Annex I 

An  impact  assessment  on  options  addressing  the  following  issues  has  been  carried 
out: hydrogen, heavy fuel oil, aerosols, and sodium hypochlorite. Only the costs and 
benefits of options that represent possible changes are included. 

Hydrogen 

The  options  for  this  component  are  either  to  keep  the  existing  situation  with 
hydrogen  as  a  named  substance  with  5/50  tonnes  as  thresholds  or  to  delete  it  and 
leave it covered by the generic classification for extremely flammable gas with 10/50 
tonnes as thresholds. 

It  appears  that  currently  there  are  only  seven  installations  in  the  EU  that  employ 
hydrogen as an energy carrier and have inventories that exceed the existing Seveso 
threshold  quantities. There are  also a  number of small-scale  demonstration projects 
with  modest  capacities.  The  largest  of  hydrogen  compressed  gas  customers  have 
maximum inventories of about 800 kg.  

EN 

22 

   EN 

 
An increase of the lower-tier threshold from five to ten tonnes would have little or no 
impact on existing industrial establishments.  

If  hydrogen  were  to  become  a  major  energy  carrier  for  transport  systems  and  a 
network  of  filling  stations  established,  it  is  essential  that  safety  is  dealt  with  in  a 
standardised way similar to the existing situation with petrol stations, considering the 
specific hazards of this gas and the rich accident history of hydrogen. It is a question 
whether  the  option  of  deleting  hydrogen  as  a  named  substance,  so  that  the  lower 
threshold  is  increased  from  5  to  10  tonnes,  would  be  sufficient  to  cover  future 
quantities at filling stations.  

Choosing either option will have limited short term impact; increasing the threshold 
to  10  tonnes  would  at  least  postpone  the  need  for  further  adjustments  as  the  H2 
economy develops.  

Heavy fuel oil 

The impact of the no-change option (assuming heavy fuel oil were to be classified as 
Chronic  Aquatic  Toxicity  2  under  CLP  (classified  as  'toxic  to  the  aquatic 
environment according to DSD), would bring heavy fuel oil into Annex I Part 2 of 
Seveso with thresholds of 200/500 tonnes. The exact impact in terms of extension of 
scope  could  not  be  estimated,  but  it  is  likely  that  this  may  lead  to  the  inclusion  of 
some  large  energy  -  intensive  establishments  such  as  power  plants  and  cement 
producers currently not yet covered. If heavy fuel oil were to be included within the 
named  substances  listed  in  Annex  I  under  the  category  'petroleum  products',  with 
thresholds of 2500/25000 tonnes, there would very likely be no or nearly no impact 
as these thresholds  are above the amounts present in most storage sites. 

Aerosols 

Flammable  aerosols  are  a  new  CLP  category.  Currently  aerosols  are  classified  for 
Seveso  purposes  based  on  their  properties  and  quantities  of  their  flammable 
components  and  subject  to  those  thresholds.  The  estimated  number  of  aerosol  sites 
covered by Seveso is around 200 warehouses. 

The  option  assessed  is  the  setting  of  appropriate  thresholds  for  the  new  aerosols 
categories capturing the sites currently covered by the Seveso Directive, i.e. 150/500 
tonnes for aerosols containing flammable gases and 5,000/50,000 tonnes for aerosols 
not containing flammable gases. The impact on the scope of the thresholds proposed 
by  the  multi-stakeholder  Technical  Working  Group  is  unclear.  A  check  of  the 
thresholds by France confirmed their proportionality indicating a slight reduction of 
establishments  in  this  Member  State    The  analysis  of  this  proposal  for  the  EU 
suggests  that  potentially  20-40  new  sites  could  come  under  the  Directive,  which 
could amount to annual costs of around EUR 0.5 million for those sites.  

The  industry  has  raised  the  question  whether  aerosols,  due  to  their  specific 
characteristics  and  packaging,  need  to  be  covered  or  whether  establishments  with 
aerosols  present  should  be  excluded,  for  example  by  setting  higher  thresholds  to 
1300/5200  (and  5000/50000).  This  would  imply  that  the  +/-  200  establishments 
would be excluded from the Seveso Directive resulting in  cost savings of the order 
of EUR 3-4 million annually for the affected industries.  

EN 

23 

   EN 

 
In  this  context  it  is  noted  that  aerosols  have  to  comply  with  the  Aerosol  Dispenser 
Directive  (Council  Directive  75/324/EEC)  and  the  Pressure  Equipment  Directive 
(Directive 97/23/EC) as amended. This is especially important given the treatment of 
stored  and  packaged  consignments  of  aerosols  in  large  lots  of  dispensers  and 
pressure equipment in wholesale and retail storage and distribution.  

Sodium hypochlorite 

Sodium  hypochlorite,  frequently  used  in  several  Member  States  as  a  mixture 
(bleach),  has  been  reclassified  by  the  CLP  as  toxic  to  the  environment  without  the 
past  concentration  exemption  of  25%.  An  industry  survey  has  estimated  that  up  to 
about 200 or more sites, including warehouses, could consequently be caught by the 
current  Seveso  Directive,  of  which  a  significant  number  could  be  SMEs.  It  is 
estimated that the economic impact would be around 3.8 Million EUR (3.5 Million 
EUR for industry, 0.35 Million EUR for authorities see details in Annex VIII). The 
alternative  to  avoid  the  inclusion  of  such  sites  by  this  immediate  CLP  re-
classification effect would be to grant exemptions by including sodium hypochlorite 
in  the  list  of  named  substances,  with  higher  thresholds,  or  to  grant  derogations  for 
packaged products. The trade-off is therefore whether the inclusion of the additional 
sites results in improvement to the protection level that justifies the costs. 

Strictly  speaking,  the  inclusion  of  sodium  hypochlorite  already  under  the  current 
Directive is not an issue arising from the CLP alignment of Annex I itself. It is one 
example  where  a  reclassification  under  CLP  has  a  significant  impact  in  a  Seveso 
context. However  this case  raises the question whether the Directive should have a 
mechanism to mitigate undesired reclassification effects, especially for mixtures. As 
note above, one option (also for future similar cases in the future) could be to exempt 
the substance/mixture by including it as a named substance with high thresholds or to 
give an exemption for packages in small quantities.  

Other impacts 

The impact of the different options on protection levels for human health (both for 
workers and the public) and the environment will vary according to whether or not 
these lead to an increase or decrease in scope. Likewise, the impact on employment 
levels  will  also  vary.  Options  leading  to  a  decrease  in  scope  would  contribute 
towards simplification to the extent that there would be reductions in administrative 
costs. 

5.3. 

Policy issue 3:  Procedures for adapting Annex I in the future 

The main costs and benefits of the options are as follows (Annex IX provides further 
details). 

Option  (a)  (Unchanged  policy;  the  baseline)  could  lead  to  new  substances  being 
included in scope which present no major accident hazard. Given the limited scope of 
the  existing  derogation  rule  (see  below),  this  could  result  in  significant  additional 
costs,  although  it  is  difficult  to  quantify  these.  Assuming  the  number  of  new 
establishments  falling  into  scope  represented  a  5%  increase  in  the  total  number  of 
establishments,  the  total  annual  costs  would  be  around  8  million  EUR  for  industry 
(plus 800,000 EUR for competent authorities).   

EN 

24 

   EN 

 
Amendments  to  Annex  I  would  continue  to  be  via  co-decision,  which  could  entail 
significant  administrative  costs  for  Member  States,  the  Commission  and  the  co-
legislators.  In  cases  where  a  substance  should  be  added  to  Annex  I,  the  protection 
level (environmental, health and social) could be adversely affected due to the length 
of time needed for possible amendments to the Annex I to be adopted. 

Option  (b)  (Extending  the  scope  of  the  existing  derogation  rule)  would  lead  to 
increased  costs  for  industry  and  competent  authorities  in  dealing  with  derogation 
requests,  but  it  is  difficult  to  quantify  these.  The  benefits  in  terms  of  savings  for 
operators would depend on how far the scope of the derogation was extended beyond 
information  requirements  in  relation  to  the  safety  report,  but  would  be  less  than 
options (c) and (d). There would be no change in protection levels. 

There would need to be strict adherence to the harmonised criteria in order to ensure 
that operators are treated equitably so that there is no risk of possible distortions to 
competition. 

As  regards  option  (c)  (general  derogation  rule  at  EU  level),  the  costs  would  be  the 
administrative  costs  for  industry,  the  competent  authorities  and  the  Commission  in 
dealing  with  derogation  requests.  It  is  estimated  that  that  these  would  be  about 
300,000  EUR  per  annum.  However  such  costs  could  be  more  than  offset  by  the 
benefits  in  terms  of  savings  from  any  derogations  that  resulted  in  establishments 
being exempted. There would be no change in protection levels.  

For  option  (d)  (establishment-specific  derogations  at  Member  State  level)  the 
potential costs and benefits would be potentially greater than for option (b), but are 
difficult  to  estimate.  It  would  allow  greater  flexibility  in  the  application  of  the 
Directive  at  Member  State  level  but  the  risks  of  possible  distortion  to  competition 
would also be greater so there would need to be close monitoring to ensure that the 
criteria were being respected. 

As  regards  option  (e)  (safeguard  clause),  the  impacts  would  depend  on  how  often 
such a clause is used. If and when used, the benefit will be an increased protection 
level  for  human  health  and  the  environment.  The  costs  will  be  the  compliance  and 
administrative costs for industry and the competent authority.  

The benefits of using delegated acts to effect changes to Annex I from application of 
options (c) and (e) would be increased speed, flexibility and efficiency in amending 
Annex I. The administrative cost would be relatively limited since the task would be 
taken up by the Commission using existing consultation procedures. The protection 
level would remain the same or slightly increase. 

Other impacts 

This  package  of  correction  mechanisms  will  mitigate  the  effects  of  the  Annex  I 
alignment  (policy  issue  1,  also  to  some  extent  policy  issue  2)  without  jeopardising 
protection  levels  for  human  health  (both  for  workers  and  the  public)  and  the 
environment. The derogation possibilities in particular will also mitigate any effects 
on employment. 

EN 

25 

   EN 

 
The  package  will  also  lead  to  savings  in  administrative  costs  and  simplification  in 
terms of speedier and efficient decision-making through the use of delegated acts to 
amend Annex I. 

5.4. 

Policy issue 4: Information to the public and information management systems 
including reporting 

The costs and benefits of the various options are as follows (see Annex X for more 
details). 

A) Options for type of information provided 

The  baseline  or  unchanged  policy  option  (a)  would  impose  no  additional  costs  on 
operators or public authorities and bring no improvements in information provision. 
Indeed  current  deficiencies  in  implementation  would  remain,  resulting  in  different 
levels of protection across Member States, which could result in the public's 'right to 
know'  being  ignored,  and  in  particular  those  that  could  be  affected  by  accidents 
failing to be aware of what action to take in the event of a disaster. 

As  regards  option  (b)  (Annex  V  information  made  available  on  line)  since  all 
Member  States  can  be  assumed  to  have  governmental  websites  where  this 
information could be placed, and the information should be produced already, there 
should  be  no  significant  additional  costs  to  competent  authorities  or  operators.  For 
authorities, it is estimated that the total one-off costs would be about 1 million EUR. 
Maintenance costs would be limited. 

The benefit of this option would be that it would be easier for the public to access the 
information  and  easier  for  each  competent  authority  to  monitor  that  it  is  actually 
available and up to date.  

Option  (c)  would  extend  the  Annex  V  requirement  in  two  ways.  Firstly,  basic  data 
for all establishments would be included.  Secondly, for all upper-tier establishments, 
information  would  be  included  about  the  main  type  of  major  accident  scenarios  as 
well as appropriate information from the external emergency plan.  

The former would not entail any significant additional costs since this information is 
produced  already  and  submitted  to  the  Commission.  For  the  latter,  operators  of 
upper-tier establishments already have to provide details of major accident scenarios 
in their safety reports that they are required to submit to the competent authorities; 
and  competent  authorities  are  already  required  to  draw  up  an  external  emergency 
plan. It is estimated that the new requirements would result in total one-off costs of 
2-4 million EUR. The annual costs of updating the information would be about 0.5 
million EUR. 

In  addition  to  the  benefits  of  option  (b),  this  option  would  ensure  that  some  clear 
basic information about the nature of the accidents hazards and information on how 
to  behave  in  case  of  an  accident  is  provided.  This  is  likely  to  facilitate  a  more 
adequate  response  in  case  of  a  major  accident  taking  place  and  thereby  reduce  the 
impacts  of  such  accidents.  It  could  also  help  operators  and  competent  authorities 
draw lessons from the best practices of others. 

EN 

26 

   EN 

 
 
Option  (d)  would  add  to  option  (c)  by  requiring  also  addition  non-technical 
summaries of the key documents, the safety report and the external emergency plans, 
to be made publicly available. As noted in (c) above the full documents already have 
to be produced by the operator and competent authority respectively so the only new 
requirement would be to summarise these for public use. 

It  is  estimated  that  the  total  one-off  costs  for  all  upper-tier  establishments  could  of 
the  order  of  EUR  20  million  (of  which  EUR  3  to  4  million  would  be  costs  for 
competent authorities) assuming that no such documents are currently produced. On 
the assumption that the information would need to be updated every three years, the 
average  total  annual  costs  of  updating  the  material  would  be  around  EUR  2-5 
million. 

The additional benefit of this option is that more detailed information from the non-
technical summaries will further increase the population's awareness of the possible 
risk  scenarios  and  the  need  to  understand  and  follow  the  advice  included  in  the 
emergency  plans.  Furthermore,  it  will  generally  inform  the  interested  public  about 
major accident potential issues. 

Other impacts  

Options  (b)  to  (d)  would  not  preclude  other  methods  of  making  the  information 
available or impact on the operator's role and responsibilities.  

There  would  be  positive  impacts  on  protection  levels  for  human  health  (both  for 
workers and the public) and the environment. The impact on employment levels will 
also vary in line with the economic impact but should not be significant. Over time 
the  use  of  the  internet  will  lead  to  streamlining  and  simplification  in  making 
information available and keeping it updated. 

There  could  also  be  costs  arising  from  security  and  other  confidentiality  concerns. 
Article  20  of  the  Directive  (which  will  need  to  be  brought  into  line  with  Directive 
2003/4/EC  on  public  access  to  environmental  information)  provides  a  safeguard 
mechanism.  Defining in each case where the balance lies between transparency and 
for  competent 
confidentiality  could  potentially 
authorities.  It  is  very  difficult  to  estimate  these  costs  as  it  depends  on  how  many 
establishments  there  are  where  confidentially  and/or  security  issues  are  significant. 
Moreover  these  costs  are  not  necessarily  additional  costs  as  Member  Status  should 
already be making such assessments. 

increase  costs,  particularly 

B) Options for information management 

Option  (a),  the  baseline,  would  maintain  the  status  quo,  with  the  generally  fairly 
limited  on-line  systems.  It  thus  imposes  no  additional  costs  on  operators  or  public 
authorities and brings no improvements. 

Option  (b)  (Member  State  databases)  would  require  all  Member  State  to  have  a 
system  that  allows  public  access  to  relevant  information  for  each  establishment. 
Since  this  would  require  only  a  simple  website  structure  and  uploading  relevant 
documents and information for each establishment, this should not entail significant 

EN 

27 

   EN 

 
resources. It is estimated that the total one-off costs would be about 1 million EUR. 
Maintenance costs would be limited. 

The benefit of this option would be that it would facilitate the online availability of 
options (b) to (d) in part A) above in relation to the type of information to be made 
publicly available. Having to upload information for each establishment will make it 
easier  for  Member  States  to  monitor  that  this  information  (which  is  required  to  be 
publicly  available)  actually  exists  and  is  available.  In  principle  it  should  therefore 
help to reduce enforcement costs once the system is in place, though this benefit can 
not be quantified. 

Option  (c)  would  establish  a  central  EU  website  that  can  be  used  to  access 
information in all Member States either through links to documents directly uploaded 
on to it or links to Member State websites/databases.  

Such  a  central  database  would  not  be  very  costly  as  it  would  use  existing  IT 
to  be 
infrastructure  and  existing  databases.  If 
made/uploaded  for  all  establishments  the  total  set-up  costs  would  be  around  0.5  to 
one  million  EUR.  The  operation  and  maintenance  costs  would  be  about  50,000  to 
100,000 EUR per year. 

links  or  documents  need 

In addition to the benefits of option (b), this option has the added benefit that it will 
make sharing of relevant information more efficient. Not only will it provide easier 
public access to the information, it will also support the competent authorities in their 
activities. 

As regards option (d), this would be a centralised EU database with all information 
integrated  within  it.  This  would  be  a  more  resource  intensive  solution  and  would 
necessitate Member States adapting their existing systems.   

The  specific  costs  of  such  an  approach  cannot  be  estimated  without  a  detailed 
analysis of the system requirements, but are likely to be very substantial. 

The benefits of this option would be the same as option (c). 

Other impacts 

Modalities  for  putting  the  information  online  on  Member  States'  databases 
(integrated database at national level, or links to operators' websites, etc) would be a 
matter for Member States.  

For options (b) to (d) there would be positive impacts on protection levels for human 
health (both for workers and the public) and the environment. Since there would be 
no costs for operators, there would be no impacts on employment levels. Over time 
the  use  of  databases  will  streamline  and  simplify  the  management  of  information. 
They  would  also  provide  a  structure  that  could  help  to  facilitate  Member  States' 
implementation reporting pursuant to Article 19.4 of the Directive.  

5.5. 

Policy issue 5: Land-use planning  

The no-change baseline option (a) would have no impact on costs. There are only a 
limited  number  of  new  establishments  and  not  many  cases  where  the  full 

EN 

28 

   EN 

 
requirements  of  Article  12  have  been  applied.  The  existing  provisions  are  being 
properly  implemented  so  the  level  of  protection  they  provide  would  remain 
unchanged.  

Option  (b)  suggests  minor  clarifications.  The  additional  administrative  costs  would 
be  limited  and  indeed  there  could  be  savings  if  the  references  to  the  EIA/SEA 
Directives led to more coordinated consultation procedures.   It is difficult to assess 
whether more specific references to environmental aspects will have any significant 
impact  since  this  depends  on  current  practices  in  the  Member  States.  In  principle 
such  aspects  should  have  been  addressed  already  by  competent  authorities  and  in 
practical  terms  there  are  unlikely  to  be  major  changes  in  the  way  they  are  already 
working.  There  could  be  some  positive  impacts  in  terms  of  improving  protection 
levels, but these are unlikely to be significant. 

Option  (c)  would  extend  the  requirements  to  all  existing  upper-tier  establishments, 
This would require competent authorities to make an in-depth site-by-site analysis of 
the  situation  to  assess  whether  or  not  there  are  appropriate  safety  distances  and  to 
identify  what  remedial  land-use  measures  such  as  relocation  of  establishments  or 
neighbouring population might be needed after existing risk reduction measures have 
been  taken  into  account.  It  is  estimated  that  such  work  alone  would  result  in  total 
costs of more than EUR 130 million. The form these remedial measures could take 
would be a matter for the competent authorities. Physical modifications or relocation 
of plants could lead to very substantial additional one-off costs, but it is very difficult 
to quantify these. Data from one Member State indicate that if all its 420 upper-tier 
establishments  were  forced  to  relocate,  the  costs  would  be  about  2.3  billion  EUR. 
However it is difficult to extrapolate this since to the whole of the EU since it is not 
known  how  many  existing  sites  would  be  affected,  which  would  depend  on  their 
specific  characteristics,  the  surrounding  environment,  and  the  policy  approach 
followed  by  the  authorities.  More  details  are  included  section  5.10.1  of  the  Impact 
Assessment Study (7). The potential benefits in terms of protection levels could also 
be very significant, although again it is difficult to quantify these.  

Other impacts 

Options (a) and (b) would have no significant impacts on protection levels for human 
health  (both  for  workers  and  the  public)  and  the  environment  or  on  employment 
levels.  Option  (c)  could  have  significant  impacts  given  the  potentially  significant 
costs and benefits. 

Option  (b)  would  contribute  towards  better  regulation  by  making  the  existing 
provisions  clearer  and  minimising  possible  divergences  in  implementation.  In 
those  under  other 
addition 
environmental  legislation  like  the  EIA  and  SEA  Directives  should  help  to  reduce 
administrative costs.  

integration  of  procedures  with 

the  envisaged 

5.6. 

Policy issue 6: Clarifications to facilitate effective implementation 

A) Closer coordination, integration of information and procedures, etc 

This  option  takes  together  several  option  components  to  facilitate  effective 
implementation  and  enforceability.  The  no-change  option  would  have  no  impacts, 

EN 

29 

   EN 

 
positive  or  negative.  Overall  only  a  qualitative  assessment  of  the  impacts  of  the 
components is possible. The impact is likely to be positive in terms of simplification 
and  reduction  of  administrative  burdens  with  possibly  some  improvements  in 
existing levels of protection. 

Coordination of inspection requirements of different pieces of legislation may result 
in a more consistent assessment and reduce administrative burdens for the operator 
(estimated by the study on administrative burdens to amount to savings of around 0.5 
million EUR), but may have disadvantages and could be burdensome for competent 
authorities, make inspections much more general and thereby less effective and thus 
reduce protection levels.  

Integration of information requirements with those under other applicable legislation 
may result in some simplification and reduction of administrative burdens, although 
it  is  difficult  to  quantify  these  benefits.  Likewise,  integration  of  the  procedures  for 
land-use  planning  under  Article  12  with  those  under  the  EIA  and  SEA  Directives 
could lead to similar benefits without any impact on existing protection levels. 

As regards the possible options to further facilitate more consistent implementation, 
measures  like  codifying  the  Mutual  Joint  Visits  programme  for  inspections  and 
formalising cooperation between the Commission and  Member States in support of 
implementation  would  build  on  existing  information-sharing  and  exchange  of  best 
practices  and  would  entail  no  additional  costs.  Guidance  already  exists  for  certain 
aspects  such  as  for  the  preparation  of  safety  reports  and  guidelines  for  land-use 
planning.  However  the  development  of  additional  guidance  material  would  lead  to 
greater  consistency  in  implementation  and  enforcement,  with  positive  effects  on 
protection  levels.  There  would  be  no  direct  economic  impact  as  the  direct 
administrative  costs  would  remain  the  same  as  at  present.  Overall,  these  types  of 
action could indirectly reduce costs to both operators and competent authorities since 
guidelines  could  help  to  deal  with  implementation  issues  more  effectively  and 
efficiently. However, it is difficult to quantify these indirect effects. 

B) Other issues where improvements are needed 

The  no-change  option  has  no  impacts.  The  costs  and  benefits  of  the  different 
elements  are  described  in  Annex  XI.    In  summary,  overall  these  would  have  no 
significant impact on costs but would provide some increase in protection levels. The 
two  areas  where  various  sub-options  exist  which  could  lead  to  additional  costs  are 
summarised in the table below. 

EN 

30 

   EN 

 
Impacts of options under this heading 

Option component 

Economic  
impacts 

Safety performance 
indicators (SPI) 4 

Protection level 

Other impacts 

a) Mandatory 
requirements to use SPI 

Potential 
significant costs 

Potential increase 

SPIs still under 
development; some Member 
States lack knowledge and 
experience in their use: 

b) Include reference to 
the use of SPI    

No significant 
additional costs 

Potential increase 

c) Develop guidance 

No additional 
costs 

Potential increase 

Safety management 
requirements for 
lower-tier sites 

a) Clarify existing 
provisions 

Potential small 
savings 

Unchanged 

b) Increase safety 
management 
requirements for lower 
tier to include SMS 

Potential high 
costs for those 
establishments 
that do not have 
an SMS 

Some increase 

25 million EUR 
(one-off costs) 

Increase 

c) Require mini-safety 
report and internal 
emergency plan for LT 
sites 

d) Require SMS, mini-
safety report and IEP 

Removes variation across 
MS due to difference in 
national requirement, but 
undermines two-tier 
approach 

As above. Further 
undermines two-tier 
approach 

Significant increase 

As above. Effectively 
nullifies two-tier approach. 

> 25 million EUR 
(one-off costs) 

App. 1 million 
EUR per year 

6. 

COMPARING THE OPTIONS 

Before  comparing  the  options,  it  should  be  underlined  that  these  options  do  not 
represent new policies as such, rather technical adaptations to existing provisions.  

6.1. 

Policy issue 1: Alignment of Annex I to GHS 

In  summary,  a  comparison  with  the  current  situation  shows  that  the  impact  of  all 
options, as well as the difference of impacts between the various options, is limited. 
An increase in scope would result in increased compliance costs and an increase in 
the  level  of  protection.  Whilst  SMEs  are  particularly  sensitive  to  cost  impacts,  no 

4 SPIs: Indicators used to mean observable measures that provide insights into a concept – safety – that is difficult to measure directly 
(OECD SPI Guidance: http://www.oecd.org/dataoecd/7/15/41269639.pdf ) 

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31 

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evidence was found that SMEs would be more concerned by the potential change of 
scope than large businesses. 

The  Directive  currently  covers  about  10  000  establishments.  Whatever  the  option 
chosen,  the  scope  variation  would  be  limited  to  a  maximum  of  415  establishments 
currently  covered  falling  out  of  the  scope  of  the  Directive  (-4.1%)  and  342 
establishments newly falling under the scope of the Directive (+3.4%). It is common 
to all options that the particularities of the alignment of 'Very Toxic' to 'Acute Toxic 
1' leads to an exclusion of 314 establishments.  

Option  C,  contrary  to  options  E  and  E*,  would  include  oral  toxicity  which  would 
bring  under  the  scope  of  the  directive  131  additional  establishments.  The  overall 
scope  change  would  be  131  new  sites,  324  out.  This  option  suggests  treating  the 
three inhalation routes differently, which would be difficult to apply in practice as all 
three  inhalation  exposure  routes  use  the  same  hazard  labelling  statement  H331. 
Furthermore,  the  exclusion  of  dermal  toxicity  and  vapour  inhalation  which  are 
possible  exposure  routes  in  case  of  accident  could  weaken  the  protection  level. 
However  covering  substances  that  display  oral  toxicity  and  for  which  complete 
information on dermal and inhalation may not be available has a favourable effect on 
the protection level.  

Option D would include Acute Toxic 3 for all exposure paths. Contrary to option C, 
it would keep all inhalation routes together. Contrary to option E and E*, it includes 
oral toxicity since for many substances complete information is limited mainly to this 
exposure route, and a correlation between oral and other types of toxicity cannot be 
excluded,  as  observed  for  many  substances  for  which  information  is  available  for 
different  exposure  routes.  This  would  bring  under  the  scope  of  the  Directive  121 
additional facilities. Therefore the impact on the scope would be 342 new sites, 314 
out. The main advantages of this option would be (1) covering all exposure paths that 
are  relevant  in  case  of  accident,  (2)  covering  some  substances  that  display  oral 
toxicity  and  for  which  complete  information  on  dermal  and  inhalation  may  not  be 
available,  and  (3)  the  substances  covered  are  all  labelled  with  "danger"  and  the 
symbol "skull and crossbones" (all toxic substances of Acute Toxic 1, 2 and 3 carry 
this  label)  which  makes  implementation  by  businesses  and  public  administration 
simple. 

Option E is limited to inhalation toxicity. The scope impact would be 10 new sites, 
415  out.  Inhalation  exposure  is  an  important  exposure  route  in  case  of  accident. 
However, the level of protection would be lower because the dermal exposure route 
which  could  also  be  relevant  in  case  of  accident  is  excluded.  Furthermore,  as  oral 
toxicity is not retained in option E, and inhalation toxicity data is not available for all 
toxic  substances,  other  methods  would  need  to  be  applied  to  extrapolate  inhalation 
toxicity,  which  could  be  administratively  complicated.  Furthermore,  although  an 
identification  of  substances  covered  by  options  E  would  be  possible  by  using  the 
individual hazard labelling statements, an easy distinction is not possible just by the 
categories and the labelling. 

Option  E*  is  similar  to  E,  but  would  also  include  Acute  Toxic  3  dermal,  which 
would bring under the scope of the directive some 220 additional establishments. The 
impact on the scope would be 221 new sites, 405 out. As oral toxicity is not retained, 
and  complete  inhalation  and  dermal  toxicity  data  are  not  available  for  all  toxic 

EN 

32 

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substances,  other  methods  would  need  to  be  applied  to  extrapolate  dermal  and 
inhalation  toxicity..  Identification  of  substances  covered  by  option  E*  would  be 
possible by using the individual hazard labelling statements.  

The analysis of costs has further shown that the administrative CLP adaptation costs 
are  in  the  range  of  several  million  EUR.  Therefore,  practical  implementation  and 
administrative  burden  issues,  which  will  run  over  a  long  period  beyond  the  initial 
alignment to Annex I, should also be taken into account bearing in mind the general 
objective of simplification.  

In  the  light  of  this  assessment,  option  E*  is  the  preferred  option  as,  in  addition  to 
having  a  relatively  limited  impact  on  scope,  shared  with  other  options,  option  E* 
maintains  a  high  level  of  protection  taking  into  account  the  most  likely  exposure 
routes (dermal and inhalation) in the event of a major accident. 

6.2. 

Policy issue 2: Other technical amendments to Annex I 

Hydrogen 

The option to increase the lower-tier threshold quantity for hydrogen from five to ten 
tonnes would have little or no impact on existing industrial establishments. Choosing 
either  option  will  have  limited  short  term  impact;  increasing  the  thresholds  to  10 
tonnes would postpone the need for further adjustments as the H2 economy develops 
to a later date. At this stage the preferred option is to leave the threshold unchanged, 
although it should be recognised that appropriate risk management may be required 
should the H2  economy develop in the longer-term. 

Heavy fuel oil 

If  heavy  fuel  oil  were  to  come  under  the  scope  of  the  Directive  due  to  its  changed 
classification, this may bring some energy-intensive establishments using heavy fuel 
oils under the scope of the Directive. If heavy fuel oil were to be included within the 
named  substances  listed  in  Annex  I  under  the  category  'petroleum  products'  with 
thresholds  of  2500/25000  tonnes,  an  exemption  as  for  other  petroleum  products 
would effectively be granted and there would be very likely no or nearly no impact 
as the thresholds for petroleum products are so high. That is therefore the preferred 
option. 

Aerosols 

An  approximate  one-to-one  translation  from  the  CLP  would  keep  the  scope  nearly 
unchanged.  However,  the  option  to  effectively  exclude  aerosols  sites  by  setting 
higher thresholds would imply that about 200 establishments (mostly wholesale and 
retail  storage  and  distribution  establishments,  storing  packaged  consignments  of 
aerosols in large lots of dispensers and pressure equipment) would be excluded from 
the  scope.  The  economic  impact  would  be  of  the  order  of  up  to  EUR  3-4  million 
annually in cost savings for the affected industries. 

At  this  stage  the  preferred  option  is  the  one-to-one  translation  from  the  CLP  since 
this  would  be  consistent  with  the  Directive's  current  approach.  However  aerosols 
could  be  a  candidate  for  the  derogation  correction  mechanism  under  the  envisaged 

EN 

33 

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approach for policy issue 3 if it can be demonstrated that there is no major-accident 
hazard. 

Sodium hypochlorite 

The options to exempt this substance/mixture by including it as a named substance with 
high  thresholds  or  to  give  an  exemption  for  packages  in  small  quantities  could  lead  to 
cost savings of around 3 Million EUR. Following the CLP for this substance would be in 
line  with  the  Directive's  current  approach  and  is  the  preferred  option,  although  this  is 
another case where the derogation correction mechanism could come into play.. 

6.3. 

Policy issue 3: Procedures for amending Annex I in the future 

The assessment in section 5.3 shows that business as usual is not really an option and 
that mechanisms are needed to adapt Annex I to the Directive should its alignment to 
the  CLP  Regulation  lead  to  substances  being  included/excluded  that  do  not/do 
present a major-accident hazard. This situation could arise either as part of the initial 
alignment  to  the  CLP  (policy  issue  1)  or  subsequently  when  future  changes  to 
classification of substances via delegated acts under CLP will automatically impact 
on the scope of the Directive. 

The envisaged derogation and safeguard clauses, together with the use of delegated 
acts  to  amend  Annex  I,  would  provide  the  necessary  flexibility  to  deal  with  this 
situation.    These  are  not  separate  options,  but  necessary  elements  of  an  overall 
package, which should have a positive effect on protection levels and a net positive 
effect on costs. 

For the derogation clause, the two basic sub-options for a changed approach are: 1) to 
allow  Member  States  to  grant  establishment-specific  derogations  (sub-options  (b) 
and (d); and 2) to provide for EU-wide derogations for substances (sub-option (c)). In 
both cases, the derogations could apply to some or all of the Directive's requirements 
and would be based on harmonised criteria to be established.  

Derogations  at  establishment  level  granted  by  Member  States  could  lead  to  net 
potential cost savings for the establishments concerned. There should be no reduction 
in  protection  levels  provided  that  the  agreed  criteria  are  applied  correctly. 
Derogations  at  substance  level  throughout  the  EU  would  have  a  potentially  greater 
impact in terms of net cost savings and avoid any possible distortion that could arise 
from derogations at Member State level. Again, there would be no impact on existing 
protection  levels.  The  wider  the  scope  of  the  derogation,  the  greater  would  be  the 
cost savings. 

A  combination  of  both  sub-options  would  be  the  preferred  approach.  In  both  cases 
harmonised criteria would need to be clearly specified. 

The  safeguard  clause  (option  (e))  would  be  the  corollary  of  the  derogation  clause. 
The costs would be limited and protection levels would be increased. This could be a 
means to deal with any unwanted effects from substances falling out of scope due to 
the  alignment  of  T+  to  Acute  Toxic  1.  It  would  also  allow  for  the  coverage  of 
materials such as nanomaterials that form a potential risk.  

EN 

34 

   EN 

 
The  use  of  delegated  acts  to  amend  Annex  I  in  the  future  would  offer  a  relatively 
quick  and  efficient  way  of  making  the  necessary  changes  to  Annex  I  flowing  from 
the application of the EU-level derogation and safeguard clauses. 

6.4. 

Policy issue 4: Information to the public and information management systems 
including reporting 

A) Type of information provided 

The aim is to improve the level and quality of the information provided to the public. 
This would be in the interest of transparency and furthermore ensure that the public 
has the necessary information so to be aware of the dangers and appropriate action to 
take  in  the  event  of  an  accident.    Making  use  of  IT  tools  to  ensure  that  the 
information is readily available and kept up to date, without precluding other forms 
of  communication,  is  an  important  part  of  this.  The  different  options  for 
improvements  that  are  assessed  in  section  5.4  and  Annex  X  represent  a  scaled 
approach,  starting  from  business  as  usual  and  then  ranging  from  making  the 
information currently required available on line (option (b)) to including much more 
detailed information (option (d). The more information has to be made available, the 
greater the costs. Cost estimates mainly relate to the competent authorities since they 
are  responsible  for  setting  up  the  required  IT  tools  and  collecting  the  information 
(while   in most cases the operator will have the information). At the same time, the 
more  the  level  of  the  information  is  improved,  the  greater  the  potential  benefits  in 
terms of protection levels. 

Option (b) would have additional costs of €~1Million to make the information online 
available plus maintenance costs of the order of 50,000 to 100,000 € and would lead 
to better access to the information currently required. 

Option (c) would require additional information such as 1) basic data about all sites; 
and  2)  for  upper-tier  establishments  the  main  accident  scenarios  and  appropriate 
information from the external emergency plan; to be made available online. 1) would 
not entail any additional costs since the information exists and is already compiled in 
one way or another. 2) would entail one-off costs of 2-4 million EUR. Annual costs 
of updating the information would be 0.5 million EUR. 

Option (d) would go further and require in addition non-technical summaries of the 
safety  report  and  emergency  plans  to  be  made  available.  It  is  estimated  that  this 
option  would  entail  one-off  costs  of  around  20  million  EUR,  with  annual  costs  of 
around 2-5 million EUR for updating. 

Weighing  up  the  costs  and  benefits,  and  taking  into  account  the  need  for 
proportionality, option (c) is the preferred option. 

B) Information management 

The options under this heading represent a gradual increase in the stringency of the 
options aimed at ensuring that the information is collected, managed and shared in an 
efficient  and  streamlined  way,  thereby  also  facilitating  reporting.  Here  again,  the 
greater the scale of the improvements, the greater the costs and benefits. The various 
options are assessed in section 5.4 and Annex X. 

EN 

35 

   EN 

 
As far as improvements are concerned, option (b) would require the establishment of 
databases  at  Member  State  level.  These  databases/costs  are  one  and  the  same  as 
under option A) b). 

Option (c) would be a central EU-wide database using the existing SPIRS database 
run  by  the  Commission.  This  database  accesses  information  in  the  Member  States 
through links to documents directly uploaded on the system or with links to Member 
State websites/databases. It would have the added benefit of facilitating the sharing 
of  information  between  the  Member  States  (and  with  the  Commission).  The 
estimated additional one-off cost for setting up such a system is 1 million EUR with 
annual maintenance costs of 50,000-100,000 EUR. 

Option  (d)  would  be  a  centralised  EU-wide  database  with  all  information  fully 
integrated  within  it.  This  ambitious  option  would  involve  substantial  costs  to  adapt 
all existing systems to one database format. While this may be worth exploring in the 
longer term, it does not seem a very realistic approach at this time. 

Accordingly, option (c) is the preferred option. 

6.5. 

Policy issue 5: Land-use planning 

Apart from the no-change option, there are two options for amendments as follows. 

Option (b) the current rules would be retained with minor changes to clarify that the 
requirements  are  aimed  at  the  protection  of  the  environment  as  well  as  of  human 
health  and  to  make  reference  to  the  possible  integration  of  procedures  with  those 
under the EIA and SEA Directives (which is also relevant in the context of part A) of 
policy  issue  6).  This  is  not  expected  to  have  any  major  impacts  on  costs,  but  may 
improve protection levels. 

Option  (c)  would  extend  the  requirements  to  all  existing  upper-tier  establishments. 
As noted in section 5.5, this could have major cost implications, but would also lead 
to  significant  increases  in  protection  levels.  In  view  of  this,  and  given  the  limited 
experience with the practical implementation of such  an  approach  to date, it  would 
not be appropriate to make this policy change at this stage. 

Option (b) is therefore the preferred option. 

6.6. 

Policy issue 6: Clarifications to facilitate effective implementation 

A) Closer coordination and integration of information and procedures, etc  

It  is  difficult  to  quantify  the  impacts  of  the  options  set  out  in  section  4.6  and  5.6. 
Across all these options the impact is likely to be positive in terms of simplification 
and  reduction  of  administrative  burdens,  with  possibly  some  improvements  in 
existing levels of protection. 

Coordination  of  inspections  would  reduce  administrative  burdens  for  operators 
(estimated savings of around 500,000 EUR), facilitating sharing of information and 
harmonisation  of  inspection  practices,  although  it  is  not  clear  if  such  coordination 
would  be  more  effective  and  what  the  effects  on  the  protection  level  would  be  in 
practice. 

EN 

36 

   EN 

 
Measures  such  as  codifying  the  MJV  programme,  Commission/Member  State 
cooperation  in  support  for  implementation  and  the  development  of  guidance  would 
facilitate a more harmonised approach towards implementation and enforcement, and 
could lead to greater efficiency and effectiveness, with positive effects on protection 
levels. There would be no direct economic impact as the administrative costs would 
remain  the  same  as  at  present.  Indirectly,  support  to  implementation  in  the  above-
mentioned  forms  could  reduce  costs  to  both  operators  and  competent  authorities. 
More harmonised implementation could also reduce - if they exist - negative effects 
on competition and the internal market. The elements could therefore overall lead to 
cost  reductions  both  regarding  existing  obligations  and  new  obligations  as  part  of 
other possible amendments discussed in this report. This likely cost reduction effect 
can however not be quantified. 

B) Other improvements 

In general, the  options identified, presented and discussed in sections 4.6 and  5.6.4 
are elements that could be included in a package aimed at clarifying and improving 
certain provisions, which taken together will lead to clearer and better regulation, and 
improve protection levels without imposing significant additional costs. 

There  are  two  options  with  alternative  sub-options,  these  relate  to  1)  safety 
performance indicators; and 2) safety management requirements for lower-tier sites. 
These are discussed in Annex XI. 

On  1),  given  the  current  state  of  development  and  use  of  such  indicators  and  the 
potentially  significant  costs  involved,  making  their  use  mandatory  (sub-option  (a)) 
would  not  be  appropriate.  A  combination  of  sub-options  (b)  and  (c)  –  including  a 
reference  to  their  possible  use  and  developing  guidance  would  be  the  preferred 
option. This would entail no additional costs and still potentially increase protection 
levels. 

On 2), the sub-options are to: clarify the existing text without any substantive change 
(sub-option  (a))  or  a  range  of  graduated  sub-options  ((b)  to  (d)  that  would  increase 
the  requirements  for  lower-tier  sites.  Sub-option  (a)  could  lead  to  potential  small 
savings, with no impact on existing protection levels. As can be seen from the table 
in section  5.6.4,  for  sub-options (b)  to (d), the more stringent the  requirements,  the 
higher would be the protection levels. However there would be greater costs, which 
would increase commensurately according to which sub-option were to be followed, 
and the existing two-tier approach would be eroded. Sub-option (a) is therefore the 
preferred option. 

6.7. 

Summary Table 

The  table  below  presents  a  summary  of  the  comparison  of  the  main  options  within 
the six policy issues. A detailed table including a summary of costs/impacts, benefits 
and,  where  appropriate,  the  contribution  to  better  regulation  and  simplification,  is 
included in Annex XII.  

Explanation of the (+++, ++, +, 0, -, --, ---) summary table: 
•  "+" means increase, "0" means no effect, "-" means decrease; 
•  +, - low;  ++, -- medium,;  +++, --- strong impact; 

EN 

37 

   EN 

 
•  Preferred options are shaded in dark grey; 
Option component5 

Economic  
impacts6 
in Mio EUR 
per year 

Policy Issue 1: Alignment of Annex I 
(change of scope)8 

Protection 
level7  

Administrativ
e 
effort/comple
xity  

C 

D 

E 

E* 

Policy Issue 2: other technical amendments 
to Annex I 

Hydrogen: a) do nothing  

Hydrogen:  b)  to  grant  an  alleviation  by 
doubling the threshold 

Heavy  fuel  oil::  a)  accept  possible  re-
classification effect  

Heavy fuel oil:: b) avoid the possible effect by 
listing  as  named  substance  with  other 
petroleum products  

Aerosols: a) CLP proposal of 150/500 

Aerosols: b) higher threshold 

Sodium 
classification effect for mixtures 

hypochlorite: 

a) 

accept 

re-

Sodium hypochlorite: exemption 

Policy Issue 3:Procedure for changing 
Annex 1 

3 b)/d: Allow MS to grant derogations from 
some or all Seveso requirements based on 
harmonised criteria  

3 c): Allow EU wide substance derogations 
from some or all Seveso requirements based 
on harmonised criteria 

3 e) Introduce Safeguard clause 

+2.5 

+4.9 

-1.1 

+2.4 

0 

0- 

0+ 

0 

+ 0.5 

- 3 to 4 

+ 3.8 

- 

- 

- 

+ 

- 

+ 

-- 

- 

0 

0- 

0+ 

0 

0 

- 

+ 

- 

0 

0 

+ 

++ 

0 

+ 

+ 

0 

+ 

+ 

- 

- 

5 In this summary table, the "do nothing" options for policy issues 3,4,5,6 are not included to keep the table short and because they are no 
preferred options in line with the review objective in this regard to clarify and improve the text of the directive 
6 Economic impacts are administrative costs. Non-administrative compliance costs, for example related to such physical modifications have 
not been considered as they are very site specific, are influenced by other legislation, and it has not been possible to quantify these.  
7 The protection level aspect covers  protection against environmental damage, damage to  human health and  damage to public and private 

property. Therefore the environmental and part of the social impacts correlate directly the results regarding the protection level. 

8 In the summary tables in 6.7 and Annex XII, net figures for the Annex I alignment costs have been used. Chapter 5.1.3 and Annex VIII 

describe the alignment costs and change of scope costs and savings in more detail.  

EN 

38 

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Economic  
impacts6 
in Mio EUR 
per year 

Protection 
level7  

Administrativ
e 
effort/comple
xity  

Option component5 

Policy Issue 4A – Type of information to 
the public9 

b) Annex V information on-line 

c) Additional information on basic data for all 
scenarios  and  key 
sites  plus  accident 
information from external emergency plan for 
upper tier (revised Annex V) on line 

d)  Additional  information  plus  non-technical 
summaries of SR and EEP on line 

4B:  management 

of 

Policy 
information 

Issue 

b) MS databases 

links 

c)  Information  management:  Simple  website 
with 
to  documents  either  directed 
uploaded  on  the  EU  site  or  links  to  MS 
websites with the information/documents 

d) fully integrated central EU database  

Policy issue 5: land-use planning 

b) minor clarifications 

c) extend requirements 

Policy issue 6: clarifications 

+ 0.1 

+ 0.5 

+ 

++ 

+ 2 

+++ 

+ 0.1 

+ 0.1 

++ 

0 

billions 

+ 

+ 

+ 

0 

++ 

A)  Closer  coordination, 
information and procedures, etc 

integration  of 

- 0.5 

+ 

B) Other improvements 

Safety performance indicators 

a) mandatory requirement to use SPI 

b)Include  reference  to  the  use  of  SPI  for 
internal safety   

c) Guidance  

Safety management requirements for LT sites 

++ 

0 

0 

+ 

+ 

+ 

- 

- 

- 

- 

-- 

--- 

0 

+ 

- 

9 Confidentiality issues will be considered (see discussion in section 2.4) 

EN 

39 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
  
Option component5 

a) Clarify existing provisions 

b)  Increase  safety  management  requirements 
for lower tier to include SMS 

c)  Require  mini-safety  report  and  internal 
emergency plan for LT sites 

d) Require SMS, mini- safety report and IEP 

domino 

Other  clarifications  (such  as  underground gas 
storage, 
environmental 
aspects,  deadlines  for  emergency  plans,  and 
deadlines 
accident 
thresholds 
reporting 

effects, 

and 

for 

Economic  
impacts6 
in Mio EUR 
per year 
- 

++ 

+ 25 one-off 

+>25 one-off 

+ 1 
+ 1.5 

Protection 
level7  

Administrativ
e 
effort/comple
xity  

0 

+ 

+ 

++ 

+ 

- 

+ 

++ 

++ 

- 

It should be noted that the policy options in the six policy areas are compatible from 
the perspective of an overall policy package. There are few cross impacts where one 
option component would increase the costs of another option component. 

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

6.8. 

Effect on SMEs 

The  Seveso  approach  addressing  major  hazards  of  large  quantities  of  chemicals, 
which are predominantly present in larger companies, limits the possible impacts on 
SMEs. This is reflected in the tiered approach in the Directive's provisions, with only 
basic  requirements  for  operators  of  lower-tier  establishments,  which  take  into 
account  SMEs'  capacities.  As  this  approach  will  be  maintained,  the  impact  should 
continue to be relatively limited.  

There  are  limited  data  to  support  a  specific  assessment  of  the  impacts  on  SMEs. 
Nevertheless some indications were obtained (for example from industry in relation 
to sodium hypochlorite and from the metal finishing industry) and these are included 
in Annex VIII. Although there is not necessarily a correlation between the quantities 
of  chemicals  present  in  an  establishment  and  the  size  of  the  operator,  it  can  be 
assumed that lower-tier sites are more likely to be an SME. In the following, a rough 
assessment  is  made  of  whether  the  options  could  result  in  a  relatively  higher  cost 
burden for lower tier sites. 

In the context of the alignment of Annex I of the Directive to the CLP, it should be 
noted that SMEs and in particular smaller firms may have a lower capacity to incur 
the one-off implementation costs of the new CLP system. These costs will have to be 
incurred by these firms regardless of the alignment of Annex I to the CLP (since they 
will  occur  in  any  case  under  the  CLP).  Therefore  it  is  not  only  important  that  the 
Seveso hazard classification categories are switched to those in the CLP (as closely 
as  possible  to  a  one-to-one  translation),  but  also  that  the  necessary  changes  to  the 

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Seveso provisions are effected in time to link with the definitive entry into force of 
the CLP rules so as to ensure a smooth CLP/Seveso adaption.  

For SMEs the net benefits of the alignment of Annex I will coincide with the CLP 
benefits: a single classification system will reduce costs and administrative burdens 
as  the  future  system  will  use  the  same  classification  and  labelling  for  transport, 
storage,  and  Seveso  purposes.  The  new  system  will  reduce  the  burden  for  hazard 
identification, facilitate international trade and lead to cost savings in the long term.  

Most of the other proposed amendments to the Directive will lead to only moderate 
costs and would present only a limited proportion of existing costs. This would apply 
to  investment  as  well  as  to  administrative  costs  as  well  as  to  big  companies  and 
SMEs  alike.  If  some  of  the  more  ambitious  options  in  relation  to  imposing  further 
requirements  on  lower-tier  sites  were  to  be  included,  these  could  lead  to  more 
significant costs to SMEs.  

For  upper-tier  SMEs,  the  cost  burden  however  could  be  higher  and  some  of  the 
options have impacts on their business activity. However, apart from the example of 
the  metal  finishing  industry,  where  upper  tier  establishments  can  be  found  in  some 
MS,  there  is  limited  data  available  to  this  study  on  such  SMEs  within  the  EU. 
Therefore, no specific conclusions could be drawn. 

In  addition,  differences  in  Member  State  implementation  make  it  difficult  to  draw 
general  conclusions.  There  are  Member  States  that  have  imposed  additional 
requirements  on  lower-tier  establishments,  which  have  increased  the  administrative 
costs and hence the burden for lower-tier SMEs. In general, the approach in Member 
State  implementation (e.g. "gold-plating")  is an  important  factor in the costs facing 
any operator.  

The envisaged amendment in relation to derogations could lead to more flexibility in 
exempting  SMEs  if  it  can  be  demonstrated  that  there  is  no  major  accident  hazard 
potential related to their activity. Since this is likely to lead to reductions in costs to 
industry  overall  the  positive  effects  of  such  flexibility  provisions  could  be 
particularly important for SMEs. 

6.9. 

The  social  impacts,  effects  on  human  health,  environment,  employment,  and 
other effects 

Concerning the environment, human health and social impacts, including the effects 
on  employment,  as  explained  in  the  relevant  sections  the  impact  assessment  shows 
that  the  impact  of  the  different  policy  options  will  vary.  However  overall  the 
preferred  options,  which  are  really  modifications  to  existing  provisions,  will  not 
significantly  affect  the  current  high  level  of  environmental  and  human  health 
protection  (see  section  5),  while  they  may  have  limited  impacts  on  employment  in 
individual SMEs (see section 6.8 and Annex VIII). 

6.10. 

Simplification 

There are a number of elements in the preferred options that are identified in section 
5  that  will  contribute  towards  simplification  and  better  regulation.  It  is  difficult  to 
quantify  these  benefits  in  terms  of  savings in  administrative  costs;  in  some  areas  it 

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will  be  for  Member  States  to  decide  whether  and  to  what  extent  they  use  the 
possibilities  for  simplification  that  are  set  out.  These  are  mainly  to  be  found  under 
policy issues 4 (information to the public and management of that information) and 6 
(closer  coordination  of  inspections,  integration  of  information  and  procedural 
requirements  with  those  under  other  EU  legislation.  Option  D  for  policy  issue  1 
(alignment of Annex I) and the various clarifications to existing provisions elsewhere 
in the Directive will also contribute towards simplification. 

6.11. 

Subsidiarity and proportionality 

With respect to the subsidiarity principle, the options provide for action at EU level 
since only this will ensure that there are not significantly different levels of protection 
in  the  Member  States  or  possible  distortions  to  competition.  Member  States  will 
however retain their central role in the practical application and management of the 
Directive  and  its  implementation.  They  will  continue  to  determine  at  which  level- 
national,  regional  or  local,  action  should  be  taken  as  appropriate.  As  regards, 
proportionality,  the  preferred  options  do  not  go  beyond  what  is  necessary  what  is 
necessary to achieve the objectives. Overall there would be no impact on the existing 
Directive's proportionate approach, with the level of controls based on the quantities 
of dangerous substances present in establishments.  

7. 

MONITORING AND EVALUATION 

The  Seveso  II  Directive  has  several  monitoring  tools  to  check  its  level  of 
implementation  and  to  check  whether  the  overall  policy  objective  to  prevent  major 
accidents  and  to  mitigate  their  consequences  in  case  they  occur  is  being  achieved. 
The main indicators used are:  

a) 

the number of major accidents reported;  

b) 

the number of Seveso establishments; and  

c) 

the  provision  of  plans,  reports  and  other  information  required  from  operators 
and authorities. 

These indicators will also be valid in the future and are being derived from data that 
has to be reported by Member States to:  

a)  

an Accident database (MARS);  

b)  

a (restricted) database on establishments (SPIRS); and  

the three-yearly reporting exercise to the Commission with the Member States 

c)  
and Commissions reports published on the Commissions website.  

However, the existing monitoring tools will be simplified and streamlined as outlined 
under policy issue 4 e.g. information will only be collected once and then be made 
available  to  the  different  stakeholders  such  as  Member  States'  authorities,  the 
Commission and the public through appropriate formats. This will increase not only 
their effectiveness but also help reduce unnecessary administrative costs.  

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With  regard  to  the  specific  objectives,  set  out  in  section  3,  the  main  issue  in  the 
future will be to monitor the impact of the CLP alignment of Annex I in practice and 
the effectiveness of envisaged correction mechanisms. Indicators in this regard are: 

•  The  number  of  lower-tier  and  upper-tier  establishments,  including  information 

about their activities and the main dangerous substances concerned; and 

•  The number of derogations granted at EU and Member State level, and reasons for 
derogations including information about the activities, dangerous substances and 
hazards in the establishments concerned. 

On  the  basis  of  the  data  collected  and  the  three  yearly  implementation  reports,  the 
Commission  will  publish  overall  reports,  which  will  include  an  assessment  of  the 
progress made in implementing the changes made to the Directive and their impacts. 

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ANNEX I 

REFERENCES 

(1) 

OJ L10, 14.1.1997, p.13, as amended 

(2) 

COM(2010) 135 final, 31.3.2010 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

Commission working document-  Third progress report on the strategy for simplifying 
the regulatory environment COM(2009)17 final, 28.1.2009 

F-SEVESO – Study of the effectiveness of the Seveso II Directive, August 2008, 
conducted by EU-VRi, available at  
http://ec.europa.eu/environment/seveso/pdf/seveso_report.pdf 

Seveso II Directive – Study of the effectiveness of the requirements imposed on public 
authorities, conducted by ERM, available at  
http://ec.europa.eu/environment/seveso/review.htm 

Impact assessment study into possible options for adapting Annex I of the SEVESO II 
Directive into the GHS (final report submitted April 2010), conducted by COWI A/S, 
available at  
http://ec.europa.eu/environment/seveso/pdf/ghs_impact%20assessment.pdf 

Impact  assessment  study  into  possible  options  for  amending  the  Seveso  Directive  ( 
final  report  submitted  July  2010,  conducted  by  COWI  A/S;  when  approved,  will  be 
available at http://ec.europa.eu/environment/seveso/review.htm 

Final report (2009) Measurement data and analysis as specified in the specific contract 
5&6  on  Modules  3&4  under  framework  contract  No.  ENTR/06/61  Report  on  the 
Environment Priority Area, EU PROJECT ON BASELINE MEASUREMENT AND 
REDUCTION OF ADMINISTRATIVE COSTS 

'  Towards  a  reinforced  culture  of  consultation  and  dialogue  –  general  principles  and 
minimum  standards  for  consultation  of  interested  parties  by  the  Commission' 
(COM(2002)704 final) 

(10)  OJ L 345, 31.12.2003, p.97 

(11)  OJ L 353, 31.12.2008, p.1 

(12) 

 Analysis of the potential Effects of the proposed GHS Regulation on Its Downstream 
legislation (Commission services, August 2006). 

(13) 

 COM(2007)355 final 

(14)      OJ L 192, 8.7.1998, p.19 

(15)  Stakeholder meeting and follow-up feedback from various participants, see: 

http://ec.europa.eu/environment/seveso/review.htm 

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ANNEX II 

Detailed Description of Options as referred to in Chapter 4: 

Policy issue 1: Alignment of Annex I to the CLP 

As  noted  in  section  2.1,  the  scope  of  the  Directive  is  partly  defined  by  hazard 
classification categories which have to change to the new CLP categories. For most 
of  the  hazard  categories  listed  in  Part  2  of  Annex  I,  for  example  those  relating  to 
physical and environmental hazards, a one-to-one translation is more or less possible 
with negligible impacts. This translation work is explained in more detail in Annex 
VII.  

However,  no  such  one-to-one  translation  is  possible  with  regard  to  health  hazards. 
Substances with the health hazards ‘toxic ‘(T) and ‘very toxic’ (T+) are covered by 
the  Directive  above  the  related  quantity  thresholds  in  Annex  I.  This  hazard-based 
approach  ensures  that  all  toxic  and  very  toxic  substances  are  treated  equally 
according to their properties. To give an example, a substances is "very toxic" if its 
lethal dose is lower than 25 mg/kg. All substances with a classification value lower 
than 25 mg/kg are covered by the Directive. 

The CLP legislation includes new categories Acute Toxicity Category 1 to Category 
3 (hereinafter called ‘Acute Toxic 1’, ‘Acute Toxic 2’ and ‘Acute Toxic 3’). These 
categories  do  not  completely  correspond  to  the  old  categories  ‘toxic’  and  ‘very 
toxic’.  They  have  other  cut-off  values  for  the  lethal  doses.  To  illustrate  the 
differences,  a  substance  will  now  be  classified  Acute  Toxic  1  if  the  lethal  dose  is 
lower than 5 mg/kg, and Acute Toxic 2 if lower than 50 mg/kg. This means that both 
very  toxic  substances  (with  a  lethal  dose  between  5  and  25  mg/kg)  and  also 
substances  classified  as  toxic  (lethal  dose  between  25  and  50  mg/kg)  are  now 
allocated to one new category Acute Toxic 2.  

This  downward  (from  T+  to  Acute  Toxic  2)  or  upward  (from  T  to  Acute  Toxic  2) 
change  in  classification  could  impact  significantly  on  the  Directive’s  scope. 
Moreover unfortunately, the effects are further complicated because: 

•  The allocation from T to category Acute Toxic  2  or  3  is  more  complicated  than 

from T+ to Acute Toxic 1 or 2 (as used in the example); 

•  Acute Toxic 3 covers many non-toxic substances, which are outside scope of the 
current Directive and for which very limited reliable information is available; 

•  The  new  categories  are  divided  into  the  three  exposure  routes:  oral,  dermal  and 
inhalation,  with  the  latter  split  into  three  sub-routes  for  vapours,  aerosols,  and 
gases.  For  all  these  exposure  routes,  the  classification  cut-off  values  have 
changed.  Where  hazard  classes  are  differentiated  on  the  basis  of  the  route  of 
exposure, the substance must be classified in accordance with such differentiation. 
This  means  that  data  for  all  exposure  routes  must  be  available  to  classify 
according to the respective (strictest) class. 

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The following options have been developed to align from T+/T to Acute Toxic 1/2/3: 

Option ("0"): Unchanged policy 

This is not a valid option as set out in section 2.1. 

Option (A): Screening tool 

In  general,  it  would  be  possible  to  maintain  the  existing  scope  by  introducing  a 
screening  tool  approach.  This  option  would  introduce  a  screening  procedure,  to  be 
applied  to  groups  of  substances  or  individual  substances  that  would  enable  the 
current scope to be maintained. The procedure would apply criteria that would have 
to  be  developed  to  establish  firstly  whether  a  candidate  substance  poses  a  hazard 
based  on  its  physical  form  and  toxicity,  and  secondly  whether  the  substance  has  a 
major  accident  hazard  potential,  based  on  its  dispersive  energy  and  toxicity.  A 
technical committee would then determine whether the substance should be included 
in  Annex  I  as  a  named  substance,  using  expert  judgment  to  take  into  account  any 
additional relevant factors such as the extent of industrial use.  

Options (B) – (E*):  

All options use the alignment from T+ to Acute Toxic 1 and from T to Acute Toxic 
2, but as Acute Toxic 2 catches only a part of T, the options differ as regards which 
exposure routes of Acute Toxic 3 they include. 

Therefore the following options have been developed: 

Overview Table  

Option 

T+ 
aligned 
to 
Acute 
Toxic 1 

T 
aligned 
to  
Acute 
Toxic 2  

All exposure 
routes 

T aligned to the following Exposure Routes of  

Acute 
 Toxic 3 

Oral 

Dermal 

Inhalation 

vapour  

aerosol  

Gas 

B 

C 

D 

E 

E* 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

Option  B:  This  option  is  a  narrow  option  that  only  includes  Acute  Toxic  3  for 
inhalation aerosols.  

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Option C: This option is more inclusive than Option B as it covers Acute Toxic 3 for 
the  oral,  inhalation  aerosol  and  inhalation  gas  exposure  routes.  It  considers  that  T 
coincides for Inhalation vapour with Acute Toxic 2 and for Inhalation aerosol with 
Acute Toxic 3, representing an exact translation for these two sub-routes. This option 
was  preferred  by  the  majority  in  the  TWG  2009  where  competent  authorities  and 
stakeholders were represented. 

Option D: This option covers Acute Toxic 3 entirety. 

Option E: This option covers the three inhalation routes Acute Toxic 3. 

Option E*: This option covers the inhalation and dermal exposure routes for Acute 
Toxic 3, but excludes the oral route. 

A few additional remarks should be made. Options B-D were identified at an early 
stage  and  discussed  extensively  with  experts  and  stakeholders.  Options  E/E*  are 
possible  additional  options  that  were  subsequently  identified.  It  was  already  clear 
from  the  beginning  that  all  alignment  options  represent  for  the  T+  alignment  a 
reduction in scope as the cut-off values for two of the five exposure routes (oral and 
inhalation  aerosols)  are  lower  for  Acute  Toxic  1  than  for  T+,  whereas  for  the  T 
alignment is was unclear whether the options would lead to an extension or reduction 
in scope. A detailed analysis is in section 5.1.  

Apart from these options, many further combinations would be possible, as well as 
other  correction  measures,  possibilities  to  adapt  the  thresholds  for  the  three  Acute 
Toxic  categories,  etc.  For  this  analysis,  it  is  assumed  that  the  current  thresholds 
would be transferred to the new categories. For reasons that are explained further in 
section  5.1,  whichever  alignment  option  is  chosen,  there  is  a  degree  of  uncertainty 
over the impact over time. 

Policy issue 2: Other technical amendments to Annex I 

The policy options presented below deal with different issues where adaptation of the 
scope to technical progress may be appropriate, with alternative options as indicated. 
The  first  issue  arose  in  the  context  of  CCS  (Carbon  Capture  and  Storage) 
technologies, the second and third about energy carriers, and the last two relate to the 
first  examples  of  specific  substances/products  directly  affected  by  the  new 
classification system. 

CO2 

Under  option  (a)  -  Unchanged  policy,  CO2  would  remain  outside  the  scope  of  the 
Directive.  Under  Option  (b)  -  Include  with  appropriate  thresholds,  CO2  would  be 
included in Annex I as a named substance with 5000/10000 tonnes as lower/upper-
tier  thresholds;  or  with  lower  quantities  of  500/1000  tonnes  as  the  respective 
thresholds. 

Heavy fuel oil 

Under option (a) - Unchanged policy, Heavy fuel oil would fall within the scope of 
the  Directive  due  its  likely  classification  as  toxic  to  the  aquatic  environment,  with 
thresholds of 200/500 tonnes (lower/upper-tier). Under option (b) - Include as named 

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substance  with  appropriate  thresholds,  heavy  fuel  oil  would  be  included  within  the 
named  substances  listed  in  annex  I  under  the  category  'petroleum  products'  with 
thresholds of 2500/25000 tonnes (lower/upper-tier). 

Hydrogen 

Under option (a) - Unchanged policy, Hydrogen would remain as a named substance 
in  annex  I  with  thresholds  of  5/50  tonnes.  Under  option  (b)  -  Delete  as  named 
substance and increase threshold, Hydrogen would be deleted as a named substance, 
but would still be caught by its generic classification as an extremely flammable gas, 
for which the thresholds are 10/50 tonnes (lower/upper-tier). 

Aerosols 

Under  option  (a)  -  Unchanged  policy,  in  line  with  the  CLP  alignment  process,  the 
lower/upper-tier  thresholds  for  flammable  aerosols  containing  flammable  gases  or 
liquids  and  such  aerosols  not  containing  such  gases  and  liquids  would  be  150/500 
tonnes and 5000/50000 tonnes respectively. Under option (b) - Increase thresholds, 
the thresholds would be increased to 1300/5200 tonnes (lower/upper-tier). 

Sodium hypochlorite 

Under  option  (a)  -  Unchanged  policy,  Sodium  hypochlorite  and  mixtures  thereof 
would  fall  within  the  scope  of  the  Directive  based  on  the  CLP  classification  with 
thresholds  of  100/200  tonnes  (lower/upper-tier).  Under  option  (b)  -  Include  as  a 
named substance with appropriate thresholds or a derogation for packaged products, 
Sodium  hypochlorite  would  either  be  listed  in  annex  I  as  a  named  substance  with 
thresholds of 200/500 tonnes in line with those applicable to substances classified as 
very  toxic  to  the  aquatic  environment  up  until  the  2003  amendment  (when  these 
thresholds  were  lowered  to  100/200  tonnes);  or  alternatively  there  would  be  an 
exemption for mixtures when they are packaged in limited quantities (inner pack up 
to 5 litres and combination pack up to 30kg). 

Policy issue 3: Procedures for adapting Annex I in the future 

The uncertainties caused by the new classification system for policy issue 1 (and 2) 
suggest a need for flexible tools to be able to adapt Annex I as necessary. There are 
three  inter-related  aspects:  a  derogation  clause,  a  safeguard  clause  and  more 
generally  the  procedure  to  be  used  to  make  amendments  to  Annex  I  in  the  future. 
These  should  be  seen  as  one  overall  package.  Such  correction  mechanisms  could 
help solve the problems outlined above, including in particular subsequent changes 
to the classification of substances and mixtures under frequent updating of the CLP 
regulation  via  comitology  (equivalent  to  delegated  acts)  that  will  automatically 
impact on the scope of Annex I in a timely way by appropriate changes to Annex I. 
A pre-condition for to be effective would therefore be for adaptations of Annex I to 
be also made via delegated acts (namely options (c) and (e)).  

Derogation Rule 

Under option (a) - Unchanged policy, any amendment to Annex I would continue to 
be  via  an  amendment  to  the  Directive  adopted  by  ordinary  legislative  procedure. 
to  grant 
the  existing  derogation  rule,  allowing  Member  States 
Moreover 

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establishment-specific exemptions to upper-tier establishments based on the existing 
harmonised criteria limited to information requirements related to safety reports for 
upper-tier establishments, would be left unchanged. 

Under  option  (b)  -  Extend  scope  of  existing  derogation  rule,  the  rule,  based  on  the 
existing  harmonised  criteria  laid  down  in  Commission  Decision  98/433/EC,  would 
be  extended  to  allow  Member  States  to  grant  establishment-specific  exemptions  to 
upper-tier  establishments  covering  requirements  such  as  those  relating  to  safety 
reports, emergency plans and information to the public. 

Under option (c) - Introduce general derogation rule at EU level, there would be EU-
wide substance-specific derogations based on points 1 (criterion: physical form) and 
4 (criterion: classification) of the existing harmonised criteria which could be further 
developed, for example to covercriteria like physical form, properties, classification, 
concentration  or  generic  packaging.  The  derogations,  by  delegated  acts,  could  take 
the  form  of  reduced  requirements  or  complete  exemption  (which  could  be 
appropriate  in  cases  where  a  substance  falls  into  scope  due  to  its  generic 
classification  under  the  CLP  legislation  but  does  not  present  any  major  accident 
hazard).  The  means  could  also  vary,  for  example  by  separate  listings,  increased 
thresholds, etc. 

Under option (d): General establishment-specific derogations at Member State level, 
Member States would get the possibility to grant establishment-specific derogations 
based  on  points  2  (criterion:  containment  and  quantities)  and  3  (criterion:  location 
and quantities) of the existing harmonised criteria. The derogation would apply to all 
qualifying  establishments  and  could  take  the  form  of  reduced  requirements  or 
complete exemption. 

The policy options (b) to (d) are alternatives but certain elements of options (c) and 
(d) could be combined in various permutations.  

The basic act would include the general criteria with detailed harmonised criteria to 
be adopted by the Commission though delegated acts. The latter would be developed 
in parallel to the legislative procedure in order to be ready for adoption immediately 
after the entry into force of the amended directive. This would thus allow for ample 
time  for  adopting  derogation  decisions  before  1  June  2015,  when  CLP  rules  enter 
into effect. 

Safeguard clause 

This  option  (e)  –  Safeguard  clause,  would  complement  and  be  the  corollary  to 
options  (c)  and  (d).  It  would  deal  with  situations  such  as  those  where, 
notwithstanding  their  falling  outside  the  Directive's  scope  due  classification  under 
CLP  rules,  a  substance  presents  a  major  accident  hazard  potential  and  should  be 
covered. 

Policy issue 4: Information to the public and information management systems 
including reporting 

The  policy  options  presented  below  address  possible  improvements  as  to  how 
information of better quality can be made available more efficiently and effectively 
to the public. 

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The options presented are mutually exclusive. They all address the same problem and 
offer  different  solutions  to  it  (in  some  cases  by  including  components  from  other 
options).  They  relate  to  the  requirements  for  information  to  be  made  permanently 
available. Active dissemination of information (and the media used for disseminating 
that information and responsibility for this) would remain unaffected. 

A) Options for type of information provided 

Under option (a) - Unchanged policy, the information would be as currently required 
by Annex V of the Directive. 

Under option (b) – Annex V online, the information required by Annex V would be 
made available on-line.  

Under option (c) - Additional information, , the following information in addition to 
the  current  Annex  V  information  would  be  made  publicly  available,  including  on-
line: 

- for all establishments: basic information about each establishment similar to what is 
currently  contained  in  the  Seveso  Plants  information  Retrieval  System  (SPIRS) 
database  managed  by  the  Commission  (based  on  information  provided  by  Member 
States under Article 19.1a of the Directive); and  

-  for  upper-tier  establishments,  a  summary  of  main  major  accident  scenarios,  key 
recommendations for the public in case of an accident. 

Under  option  (d)  -  non-technical  summaries  of  key  documents,  the  additional 
information as in option (c) would be supplemented by non-technical summaries of 
the safety report and external emergency plan. 

B) Options for information management 

Under  option  (a)  -  Unchanged  policy,  existing  arrangements  would  continue  with 
Member  States  deciding  whether  they  operate  databases  and  whether  they  allow 
public access. 

Under  Option  (b)  -  Member  State  databases,  Member  States  would  be  required  to 
operate databases with public access to Annex V information. Most Member States 
already  operate  something  similar  though  there  might  not  be  public  access  to 
information about individual sites.  

Under  option  (c)  -  central  EU  wide  database  version1,  a  simple  website  would  be 
required with links to documents either directly uploaded on an adapted EU SPIRS 
site  managed  by  the  Commission  or  links  to  Member  States'  websites  with  the 
information/documents.  

Such an option would be in line with the ongoing efforts to improve the efficiency of 
information  management  -  the  Shared  Environmental  Information  System  (SEIS) 
initiative  and  the  INSPIRE  Directive  2007/2/EC  Directive  and  its  common 
Implementing  Rules  (Regulations  on  Metadata,  Data  Specifications,  Network 
Services,  Data  and  Service  Sharing  and  Monitoring  and  Reporting).  One  of  key 
principles  in  that  initiative  is  to  collect  information  only  once  and  then  share  it 

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among all relevant parties including the public. It is also about setting up IT systems 
that allow easy reporting of the necessary information. Doing this at EU level would 
bring increased benefits in terms of increased openness and transparency as well as 
greater efficiency and effectiveness. 

A  central  website  does  not  require  a  complicated  database  to  be  programmed.  It 
could be organised in various ways:  

• By Member State: Link to Member State website with relevant information - one 
link per Member State 

•  By  Member  State  and  list  of  establishments  -  each  with  a  link  to  relevant 
documents  (link  can  be  to  documents  uploaded  on  the  central  database  or  link  to 
Member States website where documents are uploaded).  

•  SPIRS  kind  of  database  with  basic  data  on  each  establishment  and  link  to 
documents  with  further  information  (will  allow  search  by  defined  parameters  - 
Member State, type of activity etc). 

Finally, Option (d) - central EU wide database version2, would be a fully integrated 
database. 

Policy issue 5: Land-use planning  

The  policy  options  set  out  below  are  alternatives  but  within  (b)  and  (c)  certain 
elements could be combined (see section 6.5 for more details). 

Under option (a) - Unchanged policy, the current system would be retained with no 
changes.  

Under  option  (b)  -  Minor  clarifications,  the  current  system  would  be  retained  with 
minor changes such as to clarify that the requirements are aimed at the protection of 
both man and environment (including taking into account areas of particular natural 
sensitivity;  and  to  make  reference  to  procedures  under  EIA  and  similar  legislation. 
Under option (c) - Extension of provisions, the obligations would be extended in full 
to all upper-tier plants, including existing plants, and it would be clarified that these 
also extend to new lower-tier plants. 

Policy issue 6: clarifications to facilitate effective implementation 

As noted in section 2.2.6, the overall aim is to clarify certain provisions to facilitate 
effective implementation and enforceability and at the same time where possible to 
introduce streamlining and simplification to reduce administrative burdens. 

A) Closer coordination, integration of information and procedures, etc 

The options would be to make no changes or to introduce measures that could reduce 
overlapping  requirements  and  unnecessary  administrative  burdens  for  operators. 
These  could  include,  for  example,  closer  coordination  of  inspections,  allowing  the 
use of reporting formats and information provided under other legislation in a Seveso 
context,  and  where  possible  integrating  procedures  such  as  those  under  land-use 
planning with those under other legislation such as the EIA and SEA Directives. 

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To further facilitate more consistent implementation, options could include codifying 
the existing arrangements for cooperation between the Member States in support of 
implementation,  including  the  Mutual  Joint  Visits  Programme  for  inspections,  and 
the  continued  development  of  tools  and  mechanisms  to  encourage  information 
exchange  and  sharing  of  best  practices  such  as  further  guidance  where  needed. 
Annex VI provides further details. 

B) Other areas where improvements are needed 

There is a raft of possible options, which could be pursued separately or combined in 
a  single  package,  to  address  the  kind  of  issues  outlined  in  section  2.2.6  where 
clarifications or greater precision would improve implementation and enforceability. 
For most those issues there is a choice of no action or minor clarifications to the text. 
However  for  some  issues,  there  is  graduated  range  of  possible  sub-options.  For 
example,  for  safety  performance  indicators  the  sub-options  range  from  introducing 
mandatory  requirements  to  softer  measures  such  as  guidance;  for  requirements  for 
lower-tier establishments around safety management, etc these range from clarifying 
the existing requirements to significantly increasing them. Annex VI provides further 
details of the kind of possible options that could be included. 

Options discarded at an early stage 

 Policy issue 1: Alignment of Annex I to the GHS 

Before options differentiating between different exposure routes were developed, and 
bearing  in  mind  that  in  addition  to  the  main  aim  of  maintaining  existing  levels  of 
protection, there was a wish to keep the new GHS categories as far as possible intact, 
two framing options were considered:  

o  a very simple alignment transferring T+ to Acute Toxic 1 and T to Acute Toxic 2, 

and 

o  a very precautionary alignment, transferring T+ to Acute Toxic 1 and 2 and T to 

Acute Toxic 3. 

However, as it was clear from the cut-off values that both options were far away from 
the current scope, they were discarded at an early stage from a detailed assessment. 

Furthermore, it should be noted that also options A and B, which were identified early 
in  the  process  and  assessed  in  detail  in  the  Impact  assessment  study,  have  not  been 
further  considered.  Option  A  has  not  been  pursued  as  the  procedures  to  apply  the 
screening tool would be complicated and it is doubtful whether a backwards-oriented 
approach  referring  to  the  current  Seveso  II  cut-off  values  would  be  sustainable  over 
time  when  the  whole  chemicals  classification  world  will  refer  to  the  new  CLP 
categories. Option B has been discarded because it would be a fourth option reducing 
the scope and reducing it more than other options by around 475 sites. 

Another option that could be used independently and also applied in combination with 
other options would be an approach based on named substances. There is already a list 
of named substances in Annex 1 Part 1. These are mainly substances whose specific 
characteristics  warrant  thresholds  different  from  those  applicable  to  the  relevant 
hazard  classification  category  under  which  they  would  fall.  Using  named  substances 

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could  be  useful  way  of  avoiding  a  reduction  in  scope.  In  particular,  in  cases  where 
there  are  only  few  substances  in  a  boundary  area,  they  could  easily  be  identified. 
However  such  an  approach  has  drawbacks.  It  is  difficult  to  identify  a  shortlist  of 
substances that should be included. Furthermore, using named substances would mean 
inequality of treatment between existing, known substances, which can be identified, 
and  new  substances  that  are  identified  subsequently.  It  has  not  therefore  been 
considered  further.  This  drop  of  the  named  substances  approach  which  had  been 
incorporated in the options B to D within the COWI study had the consequence that 
the compensation effect had to be abstracted in the options considered in this report. 

Policy issue 2: Other technical amendments to Annex I 

CO2 

The option to possibly include CO2 has been discarded due to the following reasons. 
CO2 is not classified as a dangerous substance. However, the review of the available 
data suggests that there could be a major accident hazard potential if CO2 is used in 
high quantities (for more details, see reference (7)). A preliminary analysis with two 
different upper-tier threshold limits of 1,000/10,000 tonnes found that this inclusion 
would  cover  about  10/100  existing  sites,  and  could  lead  to  administrative  costs  in 
order of EUR 0.5/2 million EUR annually, but this would not make any difference to 
the  protection  level  for  capture  and  transport  in  the  context  of  CCS.  For  storage, 
Directive 2009/31/EC on the geological storage of CO2 ('CCS-Directive') establishes 
a legal framework for the environmentally safe geological storage of CO2., and it was 
unclear  whether  Seveso  requirements  would  add  significantly  to  those  under  the 
CCS-Directive. As CCS schemes are only at an early stage, it is premature to judge 
whether  a  major  accident  hazard  would  emerge  should  the  technology  be  widely 
used in the future. Therefore, it has been decided not to include CO2 in the revised 
Seveso  Directive.  Further  development  of  the  technology  will  help  to  better 
understand any potential risks. The situation will be kept under review in the context 
of  the  CCSDirective.  As  part  of  the  review  of  the  CCS-Directive  the  Commission 
will assess and report by 31 March 2015 whether permanent containment of CO2 in 
such  a  way  as  to  prevent  and  reduce  as  far  as  possible  negative  effects  on  the 
environment  and  any  resulting  risk  to  human  health  and  the  environmental  and 
human safety of CCS has been sufficiently demonstrated. 

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Stakeholder consultation 

ANNEX III 

the 

review  process,  stakeholders 

During 
industry 
associations,  NGOs,  Member  State  competent  authorities)  were  consulted  in  a 
number of ways, as follows.  

(individual  companies, 

The  two  studies  undertaken  to  evaluate  the  effectiveness  of  the  current  Directive 
were  both  based  on  web-based  questionnaires  and  selected  follow-up  interviews, 
allowing  operators,  competent  authorities  and  NGOs  to  give  their  views.  The 
questionnaires  were  widely  publicised.  For  the  first  study  these  were  available  to 
interested  stakeholders  for  completion  from  February  to  April  2008;  and  for  the 
second  study  from  May  to  July  2009.  Both  studies  concluded  that  overall  the 
directive  is  fit  for  purpose.  Most  of  the  recommendations  related  to  guidance  and 
tools  to  support  implementation.  No  fundamental  changes  to  the  directive  in  the 
short-term were recommended (for further details see the study reports available at  

http://ec.europa.eu/environment/seveso/review.htm 

The  competent  authorities  have  been  further  consulted  through  the  committee  of 
competent  authorities  (CCA)  at  its  regular  six-monthly  meetings.    On  the  GHS 
alignment,  a  technical  working  group,  comprising  experts  from  Member  States, 
industry and environmental NGOs), was established to examine the issue and met on 
six  occasions  during  the  period  October  2008  to  November  2009.  (The  group's 
discussions  focussed  mainly  on  option  C.  Options  E  and  E*  were  identified 
subsequently  by  the  Commission  services).  The  results  of  this  work,  and  the 
accompanying impact assessment on the alignment options, were regularly discussed 
at the CCA meetings. On other subjects covered by this report, the results of the two 
evaluation studies referred to, as well an outline of the other possible amendments to 
the  Directive  that  are  envisaged,  have  also  been  presented  and  discussed  at  those 
meetings.  The  study  findings  were  broadly  accepted  as  a  good  basis  for  taking  the 
review  process  forward.  Several  seminars  held  in  conjunction  with  the  CCA 
meetings, such as those held on enforceability, on lower-tier sites and on emergency 
plans, have also provided useful inputs to the review process. 

From  these  consultations  it  can  be  concluded  that  there  is  general  agreement  that 
overall  the  Directive  is  achieving  its  objectives,  leading  to  a  recognisably  higher 
level  of  safety,  and  that  the  approach  is  appropriate  and  proportionate.  No 
fundamental changes to the Directive are required. In particular the flexibility of the 
Directive's  existing  approach,  including  the  two-tier  approach  and  the  goal-setting 
nature of the requirements, should be retained. However there was support for some 
modifications  to  clarify  and  update  several  provisions  to  improve  implementation 
and  enforceability,  while  at  the  same  time  not  unduly  adding  to  the  administrative 
burdens  on  operators.  Comments  subsequently  received  were  generally  supportive, 
although views differed on some of the details.  On policy issue 3, views varied on 
whether there was a need for extended derogations and whether Annex I should be 
amended  in  future  via  delegated  acts.  On  policy  issue  4,  Member  States  generally 
recognised the case of greater accessibility of information and that the public's right 
to  the safety report was important (but that a non-technical summary would be more 
useful). However some expressed concerns about any extension of level of detail of 

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information that should be provided and security aspects, as well as possible impact 
on existing databases at national level. The wish to retain the right to use other forms 
of communicating the information was also underlined. On policy issue 5, there was 
broad  agreement  that  no  major  changes  required,  but  that  the  provisions  could 
usefully be clarified to better reflect the aims of the provision and existing practice. 
On policy  issue 6 there was general support. 

So  far  as  other  stakeholders  are  concerned,  to  garner  further  input  a  stakeholder 
consultation meeting was also held on 9 November 2009 in Brussels. The meeting, 
which  was  publicised,  amongst  other  means,  through  'Your  Voice  in  Europe',  was 
attended  by  around  60  representatives  from  national  and  European  industry  and 
environmental  NGOs  as  well  as  individual  companies.  At  that  meeting  the 
Commission invited views on the findings of the two evaluation studies and a series 
of    questions  on  a  range  of  subjects  covered  by  this  report,  including  :  industry 
obligations  (major  accident  prevention  policy;  safety  management  systems;  safety 
reports and internal emergency plans); the public ( consultation with and information 
to  the  public;  emergency  planning  and  testing;  land-use  planning;  risk  assessment; 
reporting,  information  sources  and  data  bases)  and    application  of  the  Directive 
(scope, definitions, exclusions, readability, etc; and  review of Annex I, GHS). There 
was  also  an  opportunity  for  participants  to  give  their  general  views.  Subsequently 
around fifty written comments were received. 

The comments confirmed that no major changes to the directive are needed. Industry 
would welcome any measures that would improve coordination between authorities, 
reduce administrative burdens and lead to more consistent implementation. Many of 
the industry  comments  focussed on  the  possible extension of the Directive to other 
installations  such  as  railway  marshalling  yards  and  harbours  and  the  integration  of 
security  issues  (which  were  suggestions  made  by  EU-VRi  in  the  first  evaluation 
study referred to above) and the possible inclusion of CO2 in the context of carbon 
capture  and  storage  (which  is  addressed  further  in  this  impact  assessment).  Some 
industry  representatives  also  expressed  concern  about  any  changes  to  the  two-tier 
approach.    A  number  of  specific  sector  concerns  were  also  expressed  about  the 
impact  on  the  scope  of  the  Directive  of  the  GHS  alignment  (also  covered  in  this 
impact  assessment).  Views  of  environmental  NGOs  went  in  the  opposite  direction, 
arguing  for  extending  the  scope  of  the  Directive  and  its  requirements.  In  particular 
they called for the provisions on information to the public, etc to be brought into line 
with  the  Aarhus  Convention  on  access  to  information,  public  participation  in 
decision-making  and  access  to  justice  in  environmental  matters.  A  report  of  the 
stakeholder  consultation  meeting,  together  with  copies  of  the  presentations  made 
during the discussions and further comments, can be accessed on the Seveso review 
webpage. 

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ANNEX IV 

Background information 

The Seveso II Directive, which is based on Article 192 TFEU, was adopted in 1996.  

It  is  one  of  the  key  instruments  in  the  field  of  ‘industrial  risk  management’  and  applies  to 
fixed  industrial  sites  where  around  30  named  dangerous  substances  or groups  of  substances 
and  other  substances  falling  under  certain  EU  hazard  classifications  (very  toxic,  toxic, 
oxidising, explosive, flammable, highly flammable, extremely flammable, and dangerous for 
the  environment)  listed  in  its  Annex  I  are  present  in  large  quantities.  There  is  a  tiered 
approach to the level of controls, with the larger the quantities of substances, the stricter the 
rules. The main requirements are that all operators caught by the Directive must notify their 
activities  and  establish  a  major  accident  prevention  policy.  In  addition,  operators  of  'upper 
tier'  establishments  have  to  establish  a  safety  report,  a  safety  management  system  and  an 
internal emergency plan. There are also obligations on public authorities relating to, inter alia, 
external  emergency  plans  and  public  information  on  safety  measures  for  upper-tier 
establishments, domino effects, land-use planning, accident reporting and inspections.  

The Directive was amended by Directive 2003/105/EC, which extended its scope, mainly to 
cover  risks  arising  from  storage  and  processing  activities  in  mining,  from  pyrotechnic  and 
explosive substances and from the storage of ammonium nitrate and ammonium nitrate based 
fertilizers  following  several  major  accidents  involving  these  substances.  However  the  basic 
structure  of  the  Directive  and  its  main  requirements  have  remained  essentially  unchanged 
since its adoption. 

Currently,  the  Directive  covers  around  10,000  establishments  storing  or  using  dangerous 
substances,  mainly  in  the  chemicals,  petrochemicals,  storage,  and  metal  refining  sectors.  It 
does not apply to military establishments; nuclear safety; transport of dangerous substances; 
intermediate  temporary  storage  outside  establishments,  ports,  railway  yards;  offshore 
exploration and exploitation of minerals, including hydrocarbons; the transport of dangerous 
substances  by  pipelines;  or  (with  certain  exceptions)  mining  activities  and  waste  land-fill 
sites. 

EN 

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The breakdown of establishments by Member State is as follows: 

Country 

Germany 

UK 

Italy 

France 

Spain 

Netherlands 

Sweden 

Poland 

Belgium 

Romania 

Finland 

Czech Republic 

Greece 

Portugal 

Austria 

Hungary 

Bulgaria 

Denmark 

Ireland 

Slovakia 

Latvia 

Slovenia 

Lithuania 

Total 
number 
of plants 

Upper 
Tier 

Lower 
Tier 

Not 
known/ 
not 
applicable 

2119 

1147 

1117 

1106 

673 

384 

379 

366 

365 

277 

264 

190 

189 

164 

146 

144 

135 

121 

88 

78 

63 

60 

53 

1071 

1048 

411 

519 

553 

267 

221 

199 

158 

174 

115 

128 

115 

83 

57 

80 

64 

54 

31 

34 

41 

30 

23 

19 

736 

598 

553 

406 

163 

180 

208 

191 

162 

136 

75 

106 

107 

64 

80 

81 

90 

54 

37 

33 

37 

34 

2 

EN 

57 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Estonia 

Luxembourg 

Cyprus 

Malta 

50 

21 

16 

10 

25 

8 

10 

6 

25 

13 

6 

4 

TOTAL 

9725 

4496 

5227 

2 

•  Source: SPIRS (November 2009) 

Breakdown of Activities: 

IndustryType 
Fuel storage (including heating, retail sale, etc.)  
Wholesale and retail storage and distribution (excluding LPG)  
General chemicals manufacture (not included above)  
Power generation, supply and distribution  
LPG storage  
Production of basic organic chemicals  
Production, destruction and storage of explosives  
Processing of metals using electrolytic or chemical processes  
Chemical installations - other fine chemicals  
Chemical installations – Industrial gases  
Other activity (not included above)  
LPG production, bottling and bulk distribution  
Plastic and rubber manufacture  
Production and storage of pesticides, biocides, fungicides  
Petrochemical / Oil Refineries  
Production and storage of fertilizers  
Manufacture of food products and beverages  
Waste storage, treatment and disposal  
Handling and transportation centres  
Production of pharmaceuticals  
General engineering, manufacturing and assembly  
Production and storage of fireworks  
Processing of ferrous metals (foundries, smelting, etc.)  
LNG storage and distribution  
Production and manufacturing of pulp and paper  
Processing of non-ferrous metals (foundries, smelting, etc.)  
Agriculture  
Electronics & electrical engineering  
Water and sewage (collection, supply, treatment)  
Ceramics (bricks, pottery, glass, cement, etc.)  
Manufacture of glass  
Processing of metals  
Chemical installations - chlorine  
Medical, research, education (including hospitals, universities, etc.)  
Mining activities (tailings & physicochemical processes)  
Wood treatment and furniture  
Chemical installations - ammonia  

Percentage 
10.92% 
10.36% 
7.41% 
7.12% 
5.53% 
5.01% 
4.36% 
4.30% 
3.82% 
3.52% 
3.39% 
3.30% 
3.10% 
2.95% 
2.55% 
2.50% 
2.38% 
1.90% 
1.80% 
1.53% 
1.29% 
1.15% 
1.08% 
1.02% 
0.97% 
0.91% 
0.73% 
0.72% 
0.61% 
0.54% 
0.54% 
0.45% 
0.36% 
0.33% 
0.24% 
0.24% 
0.21% 

EN 

58 

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Shipbuilding, shipbreaking, ship repair  
Chemical installations - inorganic acids  
Manufacture of cement, lime and plaster  
Chemical installations - fluorine or hydrogen fluoride  
Chemical installations - hydrogen  
Building & works of engineering construction  
Textiles manufacturing and treatment  
Leisure and sport activities (e.g. ice rink)  
Chemical installations – carbon oxides  
Chemical installations - nitrogen oxides  
Chemical installations - sulphur oxides, oleum  

0.18% 
0.15% 
0.13% 
0.09% 
0.06% 
0.04% 
0.04% 
0.03% 
0.01% 
0.01% 
0.01% 

Total 

100.00% 

•  Source: SPIRS (May 2010) 

Every  three  years,  the  Member  States  submit  reports  to  the  Commission  on  the 
implementation  of  the  directive.  In  general,  the  Directive  is  being  correctly  transposed  and 
implemented  by  Member  States,  although  there  are  shortcomings  in  performance  in  some 
Member States; and the level of compliance by industry is good.  

Over the last 10 years or so there have on average been about 30 major accidents per year as 
can  be  seen  in  the  table  below.  It  is  very  difficult  to  derive  overall  conclusions  about  the 
accident rate trend. The reason for this difficulty is that accidents are sometimes reported late 
(so  that  numbers  in  more  recent  years  could  increase)  and  the  fact  that  the  population  of 
industrial sites is not constant. Apart for normal variation over time – industrial plants closing, 
changing  or  starting  operation  –  and  the  effect  of  2  EU  enlargements  during  this  period  (in 
2004 and 2007), there is also the effect of changes in the legislation defining the scope of the 
Seveso  II  Directive.  Following  the  2003  amendment  and  adaptations  to  EU  rules  on  the 
classification of dangerous substances many substances and establishments have entered the 
Seveso  regime.  Since  there  is  a  relatively  constant  number  of  accidents  per  year  over  an 
increasing population of establishments, this suggests that the accident rate (accidents per year 
per 1000 establishments) is declining over time. 

EN 

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35

30

25

20

15

10

5

0

.

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

EU-15 New MS + EEA

•  Source: MARS 

The costs, both economically and environmentally, of just one major accident can be 
significant,  not  just  for  the  industrial  establishment  concerned,  but  also  for  local, 
regional or national authorities in the Member State concerned, but also, in the case 
of  accidents  with  transboundary  effects,  other  countries.  It  is  often  difficult  to 
estimate the costs of such accidents, since these need to take into account, inter alia, 
the  loss  of  lives,  both  short  and  long  term  damage  to  human  health  and  the 
environment, damage to property, loss of production, loss of amenity, and the costs 
of  response  and  remedial  action.  Nevertheless  costs  estimates  have  been  made  for 
some of the more high profile accidents, which can run into EUR billions.  By way 
of example, the cost of one major accident, the explosion and fire at the Buncefield 
oil  depot  in  2005,  reached  £1  billion,  according  to  a  final  report  by  the  UK  Major 
Incident Investigation Board. This means that the overall impact of all Seveso safety 
requirements in Europe in terms of administrative costs is lower than the costs of one 
severe  accident,  and  the  costs  of  aligning  Annex  I  is  several  orders  of  magnitude 
lower.  

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Existing information obligations under the Directive 

ANNEX V 

The information obligations are closely linked to the various reporting obligations. Currently, 
there are the following information obligations and systems and reporting arrangements: 

Operators:  

To  CAs:  Notification  (Art  5),  Safety  reports  (Art  9),  Information  necessary  for  external 
emergency plans (Art 11(b)  

Information to the public: 

Directly to those around the site that could be affected (Art 13 and Annex V); and/or 

Via the CA for the use of public information (Art 13 and Annex V): adequate information on 
safety measures and requisite behaviour in "simple terms".  

The  responsibility  is  sometimes  with  operators  sometimes  with  CAs  -  the  Directive  is  not 
prescriptive. The Directive requires the information to the concerned population to be given 
regularly and without the population having to request the information (active information). It 
also  provides  that  the  information  should  also  be  kept  permanently  available  (passive 
information).  

Member State CAs: 

To  the  Commission:  Information  about  establishments  (Art19)  (information  held  in  SPIRS 
database) and three-yearly implementation report (Art 19 (4)) 

To the public: Information on safety measures (Art 13), Safety reports (13) 

Specifically in relation to Accidents: 

Operators to CA: Inform about accidents (Art 14) 

Member States to COM: Info about accident (Art 15) 

COM: Maintain database with accident info (MARS database) 

Public consultation:  

Member  States  to  undertake  public  consultation  in  case  of  new  upper  tier  establishment, 
modification of existing (Art 10) and development around existing establishments.  

Member  States  have  to  consult  the  public  in  relation  to  the  external  emergency  plans  both 
when they are first drawn up and at any later update. 

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Policy Issue 6: clarifications to facilitate effective implementation 

ANNEX VI 

The  various  issues  can  be  grouped  under  two  broad  headings:  the  need  for  closer 
integration  of  information  and  procedural  requirements;  and  the  need  to  update  or 
clarify certain provisions to facilitate implementation and enforceability. 

A) Closer coordination, Integration of information and procedures, etc 

The  review  process  identified  some  concerns  about  shortcomings  in  coordination 
between  authorities,  both  within  and  between  Member  States  that  can  lead  to 
requirements  and 
inconsistent 
unnecessary  administrative  burdens  for  operators.  The  specific  areas  concerned  are 
discussed below.  

implementation,  conflicting  or  overlapping 

Coordination of inspections 

The  Directive  requires  that  there  shall  be  a  programme  of  inspections  of  all 
establishments. Unless a programme is in place, based on a systematic appraisal of 
major  accidents  hazards  of  the  particular  establishment  concerned,  each  upper-tier 
establishment shall be subject to at least one on-site inspection every 12 months. It is 
estimated  that  around  half  of  the  installations  that  fall  under  the  Directive  also  fall 
under  the  IPPC  Directive.  Although  some  Member  States  coordinate  inspections 
performed by the various authorities involved, it has been widely suggested that such 
initiatives  should  be  extended  to  all  Member  States.    This  could  reduce  the 
administrative  burdens  for  operators  and  facilitate  the  sharing  of  information 
between IPPC and Seveso inspectors to minimise duplication. 

Mutual Joint Visits Programme 

The Commission’s support for inspection activities via the Technical Working Group 
on Inspections and the Mutual Joint Visit (MJV) Programme (established in 1999 to 
promote  technical  exchange  among  Seveso  inspectors  in  the  Member  States)  is 
widely appreciated. The Programme is currently a voluntary means to encourage the 
sharing  and  adoption  of  best  practices  for  inspections  through  a  system  of  regular 
information  exchange  with  the  aim  of  increasing  the  effectiveness  of  inspections 
practices  and  to  ensuring  a  consistent  approach  in  interpreting  and  applying  the 
Directive’s  requirements  through  inspections  across  the  Member  States.  Codifying 
this in some way in the Directive would help to that this important activity continues 
and develops further. 

Commission and Member State cooperation in implementation 

The Commission plays an active role in facilitating close coordination and sharing of 
experience  among  Member  States  and  supporting  effective  implementation  of  the 
Directive. This involves various activities, undertaken together with experts from the 
Member  States  and  other  stakeholders,  such  as  the  development  of  guidance  and 
guidelines,  preparing  answers  to  questions  on  interpretation  of  certain  provisions, 
etc;  as  well  as  the  development,  updating  and  management  of  the  Major  Accident 
Reporting  System  (MARS)  and  the  Seveso  Plants  Information  Retrieval  System 

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(SPIRS), required under Articles 15 and 19 respectively. Currently there is reference 
in  the  Directive  to  these  activities.  Including  such  a  provision  would  put  such  co-
operation on a firmer footing. 

Integration of information and procedural requirements with other legislation 

Although there is no clear evidence of significant overlaps between the Directive and 
other  legislation  such  as  the  IPPC  Directive  in  terms  of  information  requirements, 
some savings may be possible in administrative costs if these could be more closely 
integrated. For example, information used to meet the requirements in another piece 
of  legislation  could  be  re-used  to  (partly)  address  Seveso  requirements  if  these  are 
similar. Such a possibility already exists in the context of safety reports (Article 9) 
and could be extended to other provisions. 

Likewise integration of procedures under land-use planning and those under the EIA 
and SEA Directives could also help. 

Guidance 

There is general support for tools such as guidance, together with other mechanisms 
such  as  information  sharing  and  exchange  of  best  practices,  to  facilitate  more 
consistent implementation. Much has already been done in this area. However further 
guidance  could  be  considered  where  there  is  an  identified  need.  Specific  areas 
identified  in  the  review  process  have  included  safety  report  assessment  and 
emergency planning,  

B) Other issues where clarifications needed 

The issues are as follows. 

Safety performance Indicators (SPIs)  

SPIs  can  be  an  effective  tool  to  focus  on  safety  issues  and  thus  promote  a  safety 
culture  and  help  to  improve  safety  performance  levels.  Annex  III  of  the  Directive 
includes  requirements  where  SPIs  may  be  relevant  in  the  context  of  safety 
management systems. However there is no explicit reference to them.  

Some  Member  States  would  like  to  require  the  use  of  such  indicators  to  assist 
monitoring,  assessment  and  enforcement.  However  although  there  has  been 
substantial  progress  in  developing  such  indicators,  this  is  a  complex  area  and 
experience  in  using  and  analysing  them  is  relatively  limited.  Given  the  uncertainty 
whether  SPIs  are  sufficiently  mature  and  well-developed  to  form  the  basis  for  a 
mandatory tool, other options should also be considered.  

Domino effects 

A  domino  effect  occurs  when  a  Seveso  installation  is  impacted  by  an  external 
accident  in  another  installation.  In  accordance  with  Article  8,  Member  States  must 
identify  relevant  establishments  and  ensure  "a  suitable"  information  exchange 
between the two parties.  

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The  existing  provisions  are  rather  generally  worded.  As  regards  exchange  of 
information, a particular area of concern is the issue of non-Seveso establishments in 
the vicinity of Seveso establishments such as in industrial parks. It is clear that the 
Directive cannot impose obligations on operators of establishments falling outside its 
scope.  However  it  is  generally  recognised  that  it  is  important  that  Seveso 
establishments  take  into  account  the  risks  of  such  sites  in  their  notifications  and 
safety  reports  and  that  information  about  requisite  behaviour  in  the  vent  of  an 
accident is exchanged with them. 

Underground gas storage sites 

The Directive applies to natural gas if the quantity is above the thresholds laid down 
in Annex I (50/200t). However the language used in Article 4(e) about the exception 
to  the  exclusion  of  mining  activities  from  the  Directive  has  created  some  legal 
uncertainty  about  the  status  of  underground  gas  storage  sites  under  the  Directive, 
which  has  led  to  a  non-harmonised  approach  among  Member  States.  Following 
consultation with the Member States, it has been agreed that Article 4(e) needs to be 
amended to make it clear that such sites would only be excluded from the scope of 
the  Directive  if  they  fall  under  the  exploitation  (exploration,  extraction  and 
processing)  of  minerals  in  mines,  quarries  or  by  means  of  boreholes.  Since 
“exploitation”  must  be  seen  in  a  strict  sense,  this  means  that  storing  natural  gas  in 
natural strata and disused mines should thus fall within the scope of the Directive. 

Environmental aspects 

Although  the  Directive  refers  to  the  protection  of  both  human  heath  and  the 
environment,  there  are  a  few,  if  any  specific  references  to  the  latter  in  the  detailed 
provisions.  There  is  general  support  for  rectifying  this  omission.  Such  an  approach 
should apply in particular to the following provisions. 

In  Annex  II  relating  to  safety  reports,  it  would  be  advisable  that  external  accident 
causes  such  as  natural  disasters  are  taken  into  account  and  that  major  accident 
scenarios include an assessment of the  consequences for the environment and how 
these should be addressed.  

For  Annex  IV,  on  emergency  planning,  it  could  similarly  be  specified  that 
environmental  impacts  should  be  considered  and  that  appropriate  measures  to 
mitigate such impacts - typically on the aquatic environment - should be part of the 
plan.  

Including  specific  reference  to  environmental  aspects  in  Article  12  on  land  use 
planning, would also be appropriate.  

Deadlines for external emergency plans 

Emergency plans are a key tool of the directive I terms of preparedness and response 
to major accidents. In accordance with Article 11.1(c,) the competent authorities are 
obliged  to  draw  up  an  external  emergency  plan  for  each  upper-tier  establishment 
based on information provided by the operator. In the past in several Member States 
there have been significant delays in completing such plans, which has given rise to a 

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number of infringement proceedings. Setting a clear deadline could help to improve 
implementation. 

Reporting of major accidents 

Article 15 of the Directive requires that Member states shall inform the Commission 
'as  soon  as  practicable'  of  major  accidents  meeting  the  criteria  laid  down  in  Annex 
VI.  

There are two issues in this area that should be addressed.  First, there is currently no 
specific  deadline  for  when  a  Member  State  have  to  report  an  accident.  This  means 
that in some cases reports are only sent after a long delay. Secondly, section 1.1 of 
Annex VI requires the reporting of any fire or explosion or accidental discharge of a 
dangerous  substance  involving  a  quantity  of  at  least  5%  of  the  upper-tier  threshold 
laid  down  in  Annex  I.  This  means  that  an  accident  with  for  example  release  of  1 
tonne of chlorine (< 5 % of the upper tier threshold) would not require reporting. A 
reduction of the threshold to 5% of the lower tier threshold or some other threshold 
could  possibly  bring  more  accidents  with  significant  high  quantities  of  dangerous 
substances within the reporting system and improve its benefits. 

Safety management requirements for lower-tier establishments 

The safety management requirements for especially lower-tier establishments are not 
very  accurately  defined.  In  particular,  the  relationship  between  the  major-accident 
prevention  policy  (MAPP)  and  the  safety  management  system  (SMS)  is  not  very 
clear,  Article  7  stipulating  only  that  they  adhere  to  the  principles  laid  down  in 
Annex III. 

This has resulted in widely different practices among the Member States. As a result 
many  Member  States  require  lower-tier  establishments  to  require  an  SMS  in  one 
form  or  another.  Moreover  about  half  the  Member  States  go  further  and  impose 
additional requirements on lower-tier establishments such as a safety report (or mini- 
safety report) and internal emergency plans. The issue is therefore not only whether 
the  existing  provisions  should  be  clarified  (which  would  still  allow  those  Member 
States that wish to do so to impose stricter requirements) but also whether there is a 
case for the Directive’s requirements in relation to lower-tier establishments should 
be extended further bearing in mind the current two-tiered hazards-based approach. 

By way of illustration, the main options that could be pursued to address the issues 
outlined above include the following: 

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Issues/possible amendments 

Options  

A) Closer coordination/integration 

1) Unchanged policy in each area 

2) Separate options below, which could be combined in one 
package 

Coordination/  Integration of inspections  

1)  Encourage  coordination/integration 

Codify Mutual Joint Visits programme  

1)Underline  importance  of  MJV  as  means  to  encourage 
information exchange and sharing of best practices  

Member  State/Commission  cooperation  in 
implementation 

1)    Provide  a  legal  basis  for  the  Commission  to  cooperate 
with and to support Member States in developing tools and 
mechanisms to facilitate more consistent implementation  

Integration  of  information  and  procedural 
requirements 

1) Allow use of reporting formats and information provided 
under other legislation in Seveso context (e.g. information 
contained in an IPPC report); and 

Guidance  

B) other issues where clarifications are 
needed 

Safety Performance Indicators (SPIs) 

Domino effects  

2) Integrate procedures for land-us e planning cases under 
art.12 with those under the EIA and SEA Directives 

1) Develop guidance and exchange of best practices as 
regards  assessment  of  safety  reports,  emergency 
planning and in other areas if needs identified 

1) Unchanged policy in each area 
2)  Separate  options  below,  which  could  be  combined 
in  one  package  since  they  address  different  aspects 
(sub-options  for  each  aspect  are  alternatives  unless 
indicated otherwise) 

a) Mandatory requirements; or 
b) Non-binding requirements (make reference only; 
MS to decide whether to use); or  
c) Provide guidance on their use (can be combined 
with 1) or 2) 

1)  Include  requirement  for  exchange  of  information 
with  and  need  to  take  account  of  risks  from  non-
Seveso sites 

Underground gas storage sites 

1) Include within scope of Directive 

Environmental aspects 

External emergency plans 

1) Include more details in relation to the 
environmental aspects in Annex II, IV and LUP 

1)  Set  deadline  for  MS  to  complete  plans  (say  12 
months) 

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Issues/possible amendments 

Options  

Accident reporting 

Requirements 
establishments 
management, etc  

for 

lower-tier 

around 

(LT) 
safety 

1)  Set  deadline  for  MS  to  report  accidents  (say  12 
months); and 
2) Reduce reporting threshold in Annex VI 1.1 (say to 
5% of LT quantity threshold in Annex I) 
a) clarify existing requirements in annex III as regards 
MAPP (full SMS not required);or 
b) Extend full SMS to LT;or 
c) 
report(SR) 
safety 
emergency plan(IEP) for LT; or 
d)  Combination  of  2)  and  3)  :  require  SMS,  IEP  and 
mini SR 

including 

internal 

'Mini' 

The costs and benefits of these are assessed in Annex XI

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Annex I issues  

ANNEX VII 

Annex I Part 2 of the Directive contains health, physical, environmental and other hazards. 
The impacts on health hazards are explained first; further information on the other hazards 
and the translation work follows at the end of this Annex.  

Health Hazards Classification 

The CLP legislation includes new categories Acute Toxicity Category 1 to Category 
3 (hereinafter called ‘Acute Toxic 1’, ‘Acute Toxic 2’ and ‘Acute Toxic 3’). These 
categories do not completely correspond to the old categories ‘T toxic’ and ‘T+ very 
toxic’. They have other cut-off values for the lethal doses for all exposure routes. 

The  following  approach  has  been  followed  to  calculate  the  number  of  affected 
establishments: 

o  To  assess  the  differences  and  different  cut-off  values  between  the  old  very 
toxic  T+  and  toxic  T  category  and  the  new  CLP  categories,  especially  in 
between  a  narrowing  alignment  with  Acute  Toxic  2  and  the  widening 
alignment with Acute Toxic 3,  

o  To  define  the  "boundary"  areas  for  the  five  exposure  routes  around  the  old 
toxic  category  T,  one  part  of  these  areas  reduces  the  current  scope,  one  part 
widens it;  

o  To identify substances that have their determinating classification within these 

areas. 

As  the  first  step,  the  following  boundary  areas  and  108  substances  have  been 
identified: 

Table:Impact of substances in areas A1 to A7  

Area 

Number of substances 

Net effect 

A1 

A2 

A2b 

A3 

A4 

A5 

A6 

A7 

Total number of 
substances 

T+ 

2 

4 

21 

T 

9 

12 

1 

21 

6 

1 

87 

T+ 

-10% 

-19% 

T 

-10% 

14% 

-1% 

24% 

-7% 

1% 

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There  are  many  uncertainties  about  the  substances  included  in  these  areas.  Key 
uncertainties which limit the assessment include: 

•  Toxic  substances  shall  be  classified  in  accordance  with  the  differentiation  into 
different exposure routes. Often only the oral exposure data is available, however 
an available extrapolation approach for, e.g. mixtures, under CLP can be used to 
obtain  the  needed  information  for  the  other  exposure  routes,  i.e.  dermal  and 
inhalation. However, for Seveso purposes available information should be used as 
far  as  possible.  The  Seveso  attribution  of  substances  and  mixtures  should  not 
depend  on  and  delayed  by  the  application  of  methods  to  evaluate  hazard 
information.  

•  Many  substances  are  classified  and  counted  for  Seveso  due  to  their  physical  or 

environmental hazards, but the health hazards are not considered.  

•  The assessment does not include substances classified as Acute Toxic 3 Inhalation 
Vapour (Area A8, currently excluded), due to unavailability of data. Although the 
first impact assessment suggests that the number of substances in this area is low, 
this  underestimates  the  number  of  potential  new  establishments  that  could  be 
included. 

Spreading of the identified 87 toxic substances, details broken down for T:  

The results of the identified T substances 87 for the main areas:  

Net effect % 

Impact of substances in boundary areas 

Oral 

Dermal 

Inhalation 

Aerosol 
(currently 
totally 
included) 

vapour 
(currently 
totally 
excluded) 

T -> Acute 2 

-10 

T-> Acute 3 

+14 

-1 

+24 

- 

- 

- 

- 

Gas 

-7 

+1 

The second main step is to extrapolate from these lists of substances to the number 
of  sites  possibly  affected.  For  this  extrapolation,  the  following  assumptions  have 
been made: 

•  As no information on the share of establishments that fall within the scope due to 

the use of toxic substances is known, it is assumed that  

(cid:131)  The  share  of  substances  falling  into  the  scope  due  to  health 
hazards, roughly deduced from substances/activities reported to 
the SPIRS database, is 30% (sensitivity analysis: 50 per cent) 

(cid:131)  Of these, T+ accounts for 70% (low thresholds), and T for 30% 

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•  There  are  limited  data  on  why  companies  have  been  covered  by  Seveso  II  (e.g. 
how many currently fall within the scope due to health hazards is not known); 

•  The  effect  of  changes  in  substance  covered  depends  on  many  factors  (e.g. 
establishment  already  Seveso  II  site,  the  company  response,  replacement  of 
substances, reduced quantities on site);  

Below is a table with the number of affected establishments identified:10 

Absolute effect on no of establishments 

Relative effect in % 

A1 

A2 

A2b 

A3 

A4 

A5 

A6 

A7 

Lower tier 

Upper tier 

-60 

-49 

65 

-5 

114 

-119 

-32 

5 

-45 

-42 

56 

-5 

98 

-90 

-28 

5 

Total 

-105 

-91 

121 

-10 

211 

-209 

-60 

10 

Lower tier 

Upper tier 

-1.1% 

-0.9% 

1.2% 

-0.1% 

2.2% 

-2.3% 

-0.6% 

0.1% 

-1.0% 

-0.9% 

1.2% 

-0.1% 

2.2% 

-2.0% 

-0.6% 

0.1% 

As a third important step, the number of potentially affected establishments (+ or -) 
have now to be allocated to the options. 

COWI  has  calculated,  based  on  the  number  of  establishments  affected  within  the 
different areas, the effects for options A-D in detail. However, COWI factored in an 
adjustment for including in Annex I named substances to compensate for any change 
of scope, which is not followed in this IA report. Therefore the options in this report 
follow the same approach and have the same names, but the results are slightly below 
the  COWI  figures  as  they  do  not  take  into  account  the  named  substance 
compensation factor.  

Option 

Number of establishments 

% change in no of establishments 

Lower tier 

Upper tier 

Lower tier 

Upper tier 

Option A 

Option B 

Option ( C ) 

Option ( D ) 

0 

-206 

-54 

65 

0 

-136 

-34 

68 

0.0% 

-3.3% 

-1.1% 

1.1% 

0.0% 

-3.0% 

-0.9% 

1.4% 

To illustrate the differences: COWI identified for options C and D (sum of lines 3 and 4): -
88 / 133sites, whereas the unadjusted total number of establishments is -193/+28.  

10 For the hazard class Acute Toxic Inhalation Vapour Cat. 3, not assessed by the TWG (as beyond the current 
scope,  in  some  pictures  included  as  area  8)  no  substances  have  been  identified.  Substances  in  this 
hazard class would count for options D, E, E*  

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This report has calculated the following changes of number of establishments. All options 
C,D,E, E* align T+ to Acute Toxic 1. This reduces the scope by Areas A1 and A5 by 314 
sites. 

•  Option  C  adds  areas  A2b  (oral),  subtracts  A3  (dermal)  and  adds  (A7  inhalation 

gas) 

•  Option D adds areas A2b (oral), addsA4 (dermal) and adds (A7 inhalation gas) 

•  Option E subtracts areas A2 (oral), subtracts A3 (dermal) and adds (A7 inhalation 

gas) 

•  Option  E*  subtracts  areas  A2  (oral),  adds  A4  (dermal)  and  adds  (A7  inhalation 

gas) 

This leads to the following figures of establishments affected by Options C-E* used in this 
IA report: 

Option 

Change of number of establishments 

a) T+ 
alignment 

b) T alignment 
excluded sites 

C 

D 

E 

E* 

-314 

-314 

-314 

-314 

-10 

- 

-101 

-91 

b) T 
alignment  
newly 
included 
sites 

+131 

+342 

+10 

+221 

Net-effect 

-193 

+28 

-405 

-184 

% Change 
of 
establishm
ents 

-2% 

+0.3% 

-4.2% 

-1.9% 

All  options  maintain  the  current  approach,  transferring  the  current  threshold  levels 
with 5/20 and 50/200 tons to the new health hazard categories.  

Two other important aspects: 

1.) The following figure further illustrates which are the most important areas for the 
comparison of options: 

Importance of Acute Toxic 3 Oral and Dermal: 

Acute Toxic 3 

Included in Option: 

Exposure 
route 

% 
Establishments 
within Toxic 

% 
Establishments 
not within 
Toxic 

Sum/ 
total 
Number

C  

D 

E 

E* 

Oral1)  

43% 

57% 

212 

X 

X 

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Dermal 

5% 

95% 

221 

X 

X 

1)  This  exposure  route  is  less  important  for  major  accidents  where  inhalation  and 
dermal form the relevant exposure routes.   

The  analysis  shows  that  both  areas  each  have  a  similar  relevance  for  the  scope  of 
around 2% of establishments. A possible extension or reduction of scope is roughly 
equal for oral (+/- 1%), whereas it is predominantly an extension (+2%) for dermal.. 

2) The T+ Alignment to Acute Toxic 1 

The T+ alignment, which all options have in common, leads to a reduction in scope as 
the cut-off values for Acute Toxic 1 oral and inhalation aerosols are lower than before. 
An  additional  problem  for  this  alignment  is  that  there  is  a  "gap"  between  the 
thresholds  for  upper-tier  establishments  and  lower-tier  establishments  T+:  5/20t;  T: 
50/200t. Establishments with substances classified as T+ in quantities between 20 and 
50t could not only switch from upper- to lower-tier, but even fall completely fall out 
of  the  scope.  The  assessment  identified  for  the  inhalation  aerosol  exposure  route  for 
T+ an effect on the number of establishments that could be a decrease of up to two to 
three  percentage  points  or  more  within  the  EU).  However,  there  are  no  real 
alternatives  to  this  approach  given  the  need  to  keep  the  categories  as  far  as  possible 
intact and to keep as close as possible to the existing scope. 

A sensitivity analysis has been carried out for this approach. This sensitivity analysis, 
including  doubling  the  number  of  substances  by  a  factor  of  2,  show  that  the 
assumptions have to be radically changed to make a significant impact on the number 
of establishments. 

GHS" translatable" categories, physical, environmental and other hazards, etc 

For  all  Seveso  Annex  I  categories  preparatory  work  has  been  carried  out  by  a 
Technical  Working  Group  (TWG)  "Seveso  and  GHS”  chaired  by  the  Commission, 
which  reported  to  the  Committee  of  Competent  Authorities  established  under  the 
Directive.  The work was done in a transparent way, drafts and interim reports were 
publicly  available.    The  TWG  provided  suggestions  how  to  translate  the  old 
categories  to  the  new  ones.  In  cases  where  no  direct  technical  translation  was 
possible,  these  were  left  open,  especially  concerning  the  proposals  for  the  health 
hazards ‘toxic’ and ‘very toxic’. For these two important categories, separate impact 
assessment work is presented in the next section of this annex.  

For physical hazards, environmental hazards and other hazards, the TWG  not only 
provided a translation, but the group also always assessed whether the new categories 
cover  the  same  substances  as  before.  In  some  cases,  due  for  example  to  new  test 
methods,  modified  definitions,  changed  flashpoints,  etc,  the  new  categories  do  not 
match 100% the old scope. However the initial technical assessment by the technical 
experts ensured that the scope is as close as possible to the current one so that that for 
all suggested categories there is practically no impact. The results of the work will be 
summarised in a JRC Technical Report.  

The table below gives an overview of all the existing and proposed categories: 

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Hazard Class 

Existing Annex I Part 2Categories 

Proposed categories 

Health hazards  Very Toxic, Toxic 

Acute Toxic 1, 2, 3 (part of IA) 

Physical 
Hazards 

Oxidising,  Explosive,  Extremely 
Flammable,  Highly  Flammable, 
Flammable 

Environmental 
Hazards 

Other hazards 

Dangerous to the Environment 

in  combination 
Further  hazards 
with  the  R-phrases  R14  or  R14/15 
and R29.  

STOTs 

EXPLOSIVES,  FLAMMABLE 
GASES, 
FLAMMABLE 
,  OXIDISING 
AEROSOLS 
FLAMMABLE 
GASES, 
LIQUIDS, 
SELF-REACTIVES 
AND  ORGANIC  PEROXIDES, 
PYROPHORIC 
LIQUIDS, 
OXIDIZING  LIQUIDS  AND 
SOLIDS 

Hazardous 
Environment  

to 

the  Aquatic 

Other  hazards,  Hazard  statements 
EUH014,…,EUH029 

Only a few categories or groups of substances require a short additional explanation. 

- Pyrophoric solids 

Pyrophoric  solids  are  currently  not  included  in  the  Directive.  However,  to  have  a 
systematic  application  of  the  CLP  which  assigns  oxidizing  solids  and  liquids 
together,  and  also  because  they  are  subject  to  the  same  packaging  rules  under  the 
transport  of  dangerous  substances  legislation,  they  should  be  treated  the  same  as 
pyrophoric  liquids.  The  assessment  has  shown  that  only  a  few  substances  are 
expected to be affected, and that it is not possible to quantify this marginal impact. 

- STOT 

Several  very  toxic  and  toxic  substances  (with  the  labelling  risk  phrase  R39)  are 
aligned with a new category Specific target organ toxicity (single exposure) Category 
1 STOT-SE (Hazard labelling Statement H360). A comparison of substances covered 
has  shown  that  Category  1  is  the  most  appropriate.  The  alignment  covers  STOT 
single  exposure,  but  excludes  STOT  repeated  exposure  (Category  1,  H370).  Some 
substances that are currently covered as ‘toxic’ (R48), but only have chronic effects 
that  are  not  relevant  for  major  accident  hazards,  will  fall  out  of  the  scope.  The 
assessment  has  shown  that  only  a  few  substances  are  expected  to  be  affected,  and 
that it is not possible to quantify this marginal impact. 

- Other Hazards 

The current entry number 10 in Part 2 of annex I refers to “ANY CLASSIFICATION 
not covered by those given above” in combination with certain specified risk phrases. 
Since  these  risk  phrases  can  only  occur  in  combination  with  another  classification, 

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i.e.  they  are  not  ”stand  alone”  classifications  (CLP-Regulation,  Annex  II,  1.),  the 
wording ”in combination with” is superfluous. It is already inherent in the conditions 
for  assigning  these  two  risk  phrases  specified  that  they  occur  in  combination  with 
other risk phrases. Therefore, the words “in combination with” can be deleted. So far, 
this  entry  "other  hazards"  is  exceptionally  excluded  from  the  summation  rule  for 
health, physical and environmental hazards. However it could be split and referred to 
health and physical hazards which could slightly increase the scope. Data available 
indicate no significant impact on establishments covered.  

Overall  Impacts,  Costs  and  benefits  for  "translatable"  physical,  environmental  and 
other hazards 

The suggested translation by the TWG of the non-toxic hazards leads to a practically 
unchanged scope and therefore the costs relate mainly to the change in classification, 
labelling and the update of the Seveso notifications.  

Regarding  alternative  alignment  options  for  categories  related  to  the  physical 
hazards, the main issue is with aerosols. The analysis of has shown that the suggested 
approximate  one-to-one  translation  would  maintain  the  current  situation.  However, 
this issue is included in this Impact Assessment Report under policy issue 2. 

For environmental and other hazards, due to the one-to-one translation, no economic 
or other impacts have been found. 

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Cost assumptions 

ANNEX VIII 

This Annex sets out the basic cost assumptions on which the analysis in this study is based. 
They are drawn from the impact assessment studies undertaken. Although there is a degree of 
uncertainty over the impacts, the models and data used in the analysis are the best estimates 
we have based on the available data. In some areas only a qualitative assessment can be made. 
Moreover due to lack of data it is not possible to include in the impact assessment information 
concerning impacts on various types  of affected parties (large companies vs. SMEs,  UT vs. 
LT) and to show how benefits/costs evolve over time, except in a limited way 

Compliance Costs 
Costs of compliance include:  

•  Costs to establishments (divided on initial cost and recurring cost); 

-  Administrative costs 

- 

Investment and operational costs related to physical compliance measures 

•  Cost to competent authorities (administrative costs - measured in time usage (days). 

Any  establishment  facing  a  situation  where  it  is about  to  become  within  scope  of  the  Seveso  II 
Directive might have the option of either complying with the Seveso requirements or avoiding to 
become  within  scope  by supply  chain  adjustments  -  reducing  its  maximum  stocks  of  dangerous 
substances.  

One  would  assume  that  the  company  would  evaluate  the  two  alternatives  and  use  supply  chain 
measures to reduce stocks of dangerous substances if that option is cheaper than complying with 
the Seveso requirements. Thus, using the costs of complying with the Seveso requirements when 
assessing  the  impacts  of  scope  change  would  give  an  overestimation  of  the  total  costs,  as  some 
establishments  might  chose  to  apply  the  supply  chain  adjustments  to  avoid  becoming  within 
scope. 

It is not so simple to estimate the costs of physical modifications (infrastructure costs) as it is to 
estimate  the  administrative  costs.    A  company  that  looks  to  optimise  their  operations  could 
consider the risk of accident that they face: 

Identification of the events 

• 
•  Consequence (impacts of each event) 
• 
Probability of the event occurring 

For  each  event  they  might  assess  relevant  mitigation  measures  where  each  measure  will  reduce 
the consequence and/or the probability but will imply additional costs. There will be an optimum 
level of risk reduction based on the losses that the company will suffer if an accident will happen 
and  the  costs  of  reducing  or  eliminating  the  risk.  The  cost  of  an  accident  could  comprise 
production losses, clean up costs, compensation costs in case of injuries etc. In most cases some 
prevention  measures  such  as  monitoring  equipment,  leakage  detection  etc  will  be  profitable  to 

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invest  in  based  on  the  direct  financial  cost-benefit  assessment.  Not  directly  financial  elements 
such as safe working environment, reputation etc will provide further incentives to reduce risks. 
On  top  of  this,  legislation  on  worker  protection,  product/equipment  safety,  etc  might  require 
additional  measures  to  be  taken.  It  is  not  possible  to  generalise  about  whether  this  will  be 
sufficient to comply with any requirements for investment in physical measures stemming from 
the  Directive.ives  requirement  with  respect  to.  In  some  cases  it  might  be  sufficient  and  the 
company  will  only  face  the  administrative  costs  as  the  additional  costs  of  compliance  with  the 
Directive.  Even  if  physical  measures  are  required,  the  costs  of  such  measures    will  be  very  site 
specific.  

Each of the cost components are discussed in this section.  

Overall, the impact assessment should be based on the additional costs or savings compared 
to a baseline situation. It is therefore cost differences and marginal costs that are the focus. 

The  amendment  issues  being  investigated  can  result  in  either  scope  changes  (changes  to 
number  of  establishments  being  subject  to  the  Directive)  or  changes  in  the  specific 
requirements for those already in scope.  

This section describes the total costs per establishment - a figure used to estimate the marginal 
costs of changes to scope. It also includes unit costs for certain requirements of the Directive, 
and these unit costs support the assessment of changes to these requirements. A unit cost is 
for example the cost of a safety report that upper tier establishments are required to prepare. If 
an amendment option would imply that lower tier establishments had to do the same, this unit 
cost is applied to assess the marginal costs of such a possible change to the Directive.  

Administrative Costs 

The following studies include relevant information and data regarding the cost of becoming 
and being a Seveso II establishment. These include:  

•  EU-VRi (2008) Study of the effectiveness of the Seveso II Directive, August 2008; 

•  UK (2005) Regulatory Impact Assessment (final) of Seveso II; 

•  Nutek (2006) Näringslivets administrativa kostnader på miljöområdet; and 

•  The estimates presented by FEA at the 4th TWG meeting; 

•  Administrative burden study11; 

•  Data from European Committee for Surface Treatment - Plating section (CETS) 
regarding costs for the plating industry and in particular data on SME issues. 

•  Data from the International Association for Soaps, Detergents and Maintenance  Products 
(AISE) regarding costs for this industry branch related to SMEs, retailers ‘warehouses’ 
and Seveso II compliance cost issues. 

11 FINAL REPORT (2009) Measurement data and analysis as specified in the specific contracts 5&6 on Modules 
3&4under  the  Framework  Contract  n°  ENTR/06/61Report  on  the  Environment  Priority  Area,  EU 
PROJECT ON BASELINE MEASUREMENT AND REDUCTION OF ADMINISTRATIVE COSTS. 

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In particular, the study from EU-VRi (2008) presents estimates of the costs to industry based 
on  a  survey.  Estimates  here  suggest  that  costs  for  the  safety  report  are  'less  than  10  person 
months'  for  the  major  part  of  the  respondents  (62%).  On  average,  the  financial  costs  of  the 
safety report ranges from EUR 20-50 k 12. Implementation of the safety management systems 
are  for  the  major  part  of  respondents  (75%)  estimated  to  'less  than  10  person  months',  the 
same  goes  for  the  costs  of  emergency  plans  (81%  of  respondents).  The  major  part  of 
Competent  Authorities  (77%)  did  not  have  estimates  on  costs  of  administration.  A  general 
observation was that approximately half of the respondents have not estimated the costs of the 
Seveso II implementation. 

The  estimate  of  "less  than  10  person  months"  is  not  very  precise.  Assuming  that  the  other 
elements mentioned, the SMS and the IEP imply expenditure similar to the safety report, total 
costs would be about 60,000- 150,000 EUR. Though the costs of the SMS could be high, the 
IEP is less than the SR so this combined estimate of the total administrative costs is on the 
high side. As these are not annual costs, they should be annualised over  at least 5 years. In 
doing  so  the  annualised  costs  would  be  between  13,000  and  33,000  EUR  per  year.  The 
average  value  would  be  a  bit  more  than  20,000  EUR  and  would  be  for  an  upper  tier 
establishment.  

A  study  of  the  English  COMAH  estimates  'costs  to  business  …'  of  the  existing  Seveso  II 
requirements  at  GBP  42,000  (excl.  control  costs  (present  value  over  appraisal  period).  An 
appraisal period of five years (after which the safety report must be renewed), makes yearly 
costs at GBP 11,070, which equals roughly EUR 13,179. These numbers are for the lower tier 
of the COMAH - upper tier estimates range at GBP 255-268,000. The average GBP 261 500 
translated into Euro per year equals EUR 62,256. 13 

A Nutek study (2006) estimates the total costs of implementing Seveso II in Sweden at SEK 
2,203,44014. The report divides the costs on population and total hours. Although, the study 
does not reveal the number of establishments in Sweden, each cost of documentation demand 
can  be  divided  by  the  population,  and  subsequently  summarised  on  the  different  types  of 
documentation. The calculation estimates cost per establishment ranging from SEK 13,350 to 
SEK 239,972, this equals EUR 1,298 - 23,328.  

In sum, these three brief examples present an administrative compliance costs ranging from 
EUR 1,298 - 13,179 for the lower tier and EUR 23,328 - 62,256 for the upper tier per year. 

The FEA cost estimates are based on data from the survey conducted by Atkins on behalf of 
the  FEA.  The  costs  of  an  establishment  (not  manufacturing)  included  in  the  Seveso  II  are 
displayed in the following table. 

12 EU-VRi (2008) Study of the effectiveness of the SEVESO II Directive, August, pp.46-47 
13 UK (2005) Regulatory Impact Assessment (final) of SEVESO II 
14 Nutek (2006) Näringslivets administrativa kostnader på miljöområdet 

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Aerosol Industry estimate of Seveso II costs 

Lower tier 

Upper  tier 

Duty holder initial costs 

Competent authority costs 
(first five years) 

Duty holder ongoing costs 
(first five years) 

Total costs 

Total annual costs 

197,000 

10,000 

30,000 

237,000 

50,000 

Source: Atkins 2009 on behalf of FEA 

568,000 

61,000 

183,000 

812,000 

180,000 

As  the  table  shows,  the  costs  of  becoming  a  Seveso  II  establishment  are  EUR  227,000 
including  the  initial  costs  and  current  expenses.  In  addition,  the  costs  to  the  competent 
authority are EUR 10,000  over five  years. For the upper tier establishments these  are about 
three times higher, at EUR 751,000 for the establishments (including ongoing costs for five 
years), and EUR 61,000 for the Competent Authority over five years.  

The table indicates that administrative costs to the CA are about 4-8% of the industry costs. It 
is  generally  assumed  that  costs  to  the  CA  for  inspection  etc  are  10%  of  the  administrative 
costs to the industry.  

In July 2010, the International Association for Soaps, Detergents and Maintenance Products 
(AISE) has provided the Commission, in addition to an earlier information from March 2010, 
with data collected from countries where sodium hypochlorite mixtures are largely used: 

"Table 1 – SEVESO impact on SMEs and retailers' warehouses – 

Number of sites impacted:  

SMEs 

If  classification  N, 
R50 

SMEs 

applies  to  mixtures  ≥ 
4.9  %  hypochlorite 
(active chlorine) 

Country 

If  classification  N,  R50 
applies  to  mixtures  at  ≥ 
hypochlorite 
2.5  % 
(active chlorine) 

Retailers' warehouses 

France  4 

Italy 

3 

5 

7 

  No data available 

  No data available 

UK 

 No data available 

  No data available 

57* 

Spain 

5 

18 

  No data available 

*Pilot study from a multinational company for measuring impact on customers in UK: 

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The  company  collected  and  summarised  dispatch  volumes  of  all  sodium  hypochlorite-
containing -mixtures  over  the  last  3  months  of  2008.  Average  stock  holding  per  week  was 
determined,  which  was  then  extrapolated  (based  on  market  share)  to  the  total  market  stock 
level for 141 retailer warehouses across the UK.  

Out of these 141 retailer distribution centres:  

•  84 (60%) had less than 100 tonnes of sodium hypochlorite-containing-mixtures on site and 

will not be affected by Seveso directive, 

•  57 (40%) had on average above 100 tonnes of sodium hypochlorite-containing mixtures on 

site and would require low or high tier Seveso compliance. 

Table 2 – SEVESO compliance cost estimation - 

Data were collected from France. It should be borne in mind that the costs of compliance with 
the Seveso Directive may differ significantly from one country to another due to differences 
in implementation of the Seveso Directive.  

preliminary 
study 

investments  

investments  

annual costs  

annual costs  

Company 

lower tier 

lower tier 

upper tier 

lower  tier 

upper tier 

25 000 € 

50 000 € 

30 000 € 

? 

 ?  

? 

 > 12 000 €  

> 25 000 € 

 ? 

> 100 000 € 

A 

B 

Notes:  

-  Annual  insurance  fees  will  increase  dramatically  for  companies  falling  under  the  scope  of 
Seveso. 

-  Not  included  in  the  calculation:  safety  management  study,  safety  report,  emergency  plan, 
land-use planning. 

Table 3 – SEVESO tonnages in production sites– 

These  are  examples  showing  the  impact  of  either  sodium  hypochlorite  as  a  substance  or 
packaged products for Seveso classification. 

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Sodium 
hypochlorite 
tonnage 
material, N, R50) 

(raw 

Mixtures  packaged  in  limited 
quantities  if  classification    N, 
R50 
  ≥4.9  % 
applies 
hypochlorite  

Mixtures  packaged  in  limited 
quantities  if  classification  N, 
R50  applies  at  ≥2.5  % 
hypochlorite 

Company 

C 

D 

E 

F 

G 

100 tons 

490 tons 

100 tons 

190 tons 

65 tons 

110 tons 

410 tons 

55 tons 

115 tons 

460 tons 

1390  tons 

350 tons 

850 tons 

700 tons" 

AISE concludes in this paper that the above information is provided as a means to refine the 
impact  assessment.  AISE  points  out  that  the  above  information  is  based  on  their  current 
understanding of the classification threshold (2.5% being the concentration limit based on an 
M-factor  of  10  and  4.9%  being  the  concentration  limit  based  on  test  data  on  representative 
mixtures from the sector). 

Administrative burden study 

In January 2007, the EC launched an Action Programme to reduce the administrative burdens 
in the EU with a focus on the administrative cost from EU legislation. The Programme had 13 
priority areas of which one is the environment. Within environment the Seveso II Directive is 
one  of  the  Directives  selected  for  particular  attention.15    The  study  has  estimated  that  the 
Seveso II Directive has a yearly administrative cost of EUR 52 million in total16.   

The study covered the following main activities: 

Written update of safety report (one every five years) 

Written update of internal emergency plan (updated every three years) 

Cooperation with inspectors (frequency not indicated) 

Notification  of  presence  or  changes  in  presence  of  dangerous  substances  (5-10%  of 
establishments every year) 

Based on estimates of the time spent for each activity, the hourly salary for the relevant staff, 
consultancy  support,  and  the  number  of  occurrences,  the  total  costs  for  each  activity  were 
estimated. Update of safety reports is most expensive at 19.7 million per year. The cost per 
establishment  is  therefore  around  22,000  EUR.  Updating  of  internal  emergency  plans  is 
estimated to cost 13.9 million EUR. With the occurrence of once every three years, the cost 

15 http://ec.europa.eu/enterprise/policies/better-regulation/administrative-burdens/action-

programme/index_en.htm 

16  Conclusions  of  a  DG  ENTR  study  as  part  of  the  Commission's  programme  of  reducing  the  administrative 

burdens of EU legislation (which included the Seveso II Directive) 2009 

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per establishment is around 9,300 EUR. The estimated notification cost is around 8.1 million 
EUR and that is approximately 11,000 EUR per establishment. 

Updating  of  safety  reports  and  emergency  plans  are  required  by  upper-tier  establishments 
only, while notification applies to all Seveso establishments. Using these data to estimate the 
costs of a new establishment entering the scope of Seveso II means that the costs for a lower- 
tier establishment will be around 11,000 EUR, while the costs for an upper-tier establishment 
will be around 42,000 EUR. Annualising these initial costs, the lower-tier establishment will 
have annual costs of 2,200 EUR while the cost for upper-tier establishments can be estimated 
to 10,400 EUR.  

These costs are for update of plans, etc and therefore less than what a company will face when 
it first falls within the scope of the Directive.  

Costs from CETS – the metal finishing industry 

During the Commission's general stakeholder consultation on the Seveso II Directive review, 
the European Committee for Surface Treatment provided data on costs and other information 
related to the industry's coverage by the Seveso II Directive. 

Based  on  reporting  from  several  Member  States  the  CETS  have  collected  data  on  costs  of 
complying with the Seveso. Many of the companies within the industry are SMEs.  

The collected cost data are summarised in the table below. 

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Cost data from CETS  

Country 

Netherlands 

Examples of costs 
for compliance with 
Seveso II in '000 
EUR 

Type of costs and/or comments 

44 

49 

24 

21 

Annual costs from specific company 

Annual costs from specific company 

Annual costs from specific company 

Annual costs from specific company 

200-250 

One-off entry costs - general estimate 

25 

157 

178 

Annual costs from specific company 

One-off entry costs from specific company 

One-off entry costs from specific company 

1 to 5 million 

One-off entry costs for upper tier - no actual 
upper tier company currently 

30 

25 

Annual - one company 

Lower tier one-off (general estimates from 
study on costs of COMAH (2003) 

180 

Upper tier one-off (general as above) 

Italy 

France 

Germany 

UK 

Denmark 

24 -50 

One-off entry costs 

Source: European Committee for Surface Treatment (CETS) in undated paper (costs are from 2008 or 2009) 

It  is  indicated  in  the  table  whether  the  data  refer  to  upper  or  lower-tier  establishments, 
although this information is not known for some of the examples. It is assumed that the costs 
refer to upper tier.  

If  one  takes  the  average  of  the  annual  costs  provided,  the  result  is  a  value  of  32,000  EUR, 
while the simple average of the one-off costs is 163,000 EUR.17 From the reporting, it is not 
possible to identify exactly what is included in the stated costs. It seems that the main element 
is the administrative costs, though in some examples also physical modifications are included. 

17  This  assumes  that  the  1-5  million  costs  for  upper  tier  for  France  are  excluded.  The  figure  is  significantly 

higher than any other data.  

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In  terms  of  the  difference  between  the  one-off  entry  costs  and  the  annual  costs,  it  could  be 
assumed that annual costs do not include any "depreciation" of the one-off entry costs. If the 
entry costs that are one-off are annualised over 5 years and 4%, the average annualised cost is 
about  37,000  EUR.  Adding  the  two  elements  give  a  value  of  about  70,000  EUR  as  total 
annual costs for the first 5 years; thereafter the annual costs will be less - around 30,000 EUR.  

The data from CETS includes also other relevant observations. 

•  They present an example of an SME investing 40,000 EUR in reducing the vats used in 
their manufacturing process in order to go below the Seveso threshold. There is no 
information about possible loss of income caused by this behaviour, but the investment 
cost suggests that it is cheaper to reduce the qualifying quantities of the chemicals used 
rather the complying with Seveso.  

•  The CETS paper compares the estimated Seveso costs with the typical turnover values for 
SMEs in metal finishing industry. The comparison indicates that with turnover values 
from less than one million EUR to about 10 million EUR, the share of Seveso compliance 
costs range from 0.5% to about 3%.  

Summary of costs 

The table below presents an overview of the cost data by source and the resulting costs used 
in this impact assessment. The best estimate is the average of the identified sources (except 
the high industry estimate); the low estimate is 50 per cent of the best estimate, while the high 
estimate is three times higher. 

The  cost  estimates  includes  only  the  administrative  costs  for  industry.  The  extent  to  which 
companies will need to invest in protection measures and reorganising of storage facilities etc 
is not known. Therefore costs could  be higher for new  establishments  entering  the scope of 
the  Directive.  In  general,  the  costs  of  both  safety  plans  and  physical  measures  depend  on 
whether  safety  management  systems  already  existing  due  to  other  types  of  legislation,  for 
example protection of workers. However, the estimates presented here are the best available 
estimates of the Seveso costs.  

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Overview of cost estimates in '000 EUR - total annual administrative costs per establishment 

Source 

EU-VRi (2008) 

UK (200x) 

Nutek (2006) 

FEA (2009) 

CETS (2008/9) 

Administrative Burden study (2009)1 

Average used in IA 

Low 

Best  

High 

Lower tier 

Upper tier 

- 

13 

1.3 

50 

- 

2 

2-15 

2 

5 

15 

<20 

60 

23 

180 

≈70 

10 

15-100 

15 

30 

100 

•  Note 1) This is for updates of reports and plans 

Differences in cost estimates 

The  EU-VRI  report  observes  that  the  majority  of  respondents  recognise  that  Seveso  II 
implementation differs greatly across borders, and even within a given country (EU-VRI, p. 
9).  

The  EU-VRi  (2008)  and  the  Administrative  Burden  studies  are  based  on  surveys  or 
assessments covering in principle several Member States and industries and they are therefore 
likely to be more representative.  

The variations in costs can be caused by many factors: 

•  Differences  in  actual  implementation  where  some  Member  States  have  more 

demanding requirements than others; 

•  Cost and price level differences; and 

•  Cost  elements  included  -  though  the  above  data  in  principle  cover  the 

administrative costs there could be physical measures included. 

Cost differences between Member States 

There  are  some  data  on  country-specific  costs  from  the  Administrative  Burden  study.  They 
have based the cost estimation on data from six Member States (CZ, FR, IT, LV, SK and ES). 
The country specific data show that there are differences in the time estimate for the different 
requirements and the unit costs (salary level) vary across Member States. There is a factor of 
up to 10 in the unit costs while the time spends varies by a factor 2. 

The majority of the costs of Seveso II compliance are man-hour costs. They will vary with the 
price level in each Member State. It means that the relative burden is likely to be of the same 
order of magnitude across Member State measures as costs per GDP. 

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Cost assumption for specific requirements 

Based  on  the  Administrative  Burden  study,  where  data  on  time  consumption  and  other  cost 
elements  have  been  compiled  for  key  administrative  requirements,  the  following  cost 
assumption has been applied for the impact assessment.  

Unit cost assumptions for administrative requirements - EUR per event 

Low 

Best 

High 

Notification 

Notification of change 

          3,000  

          2,500  

Safety report – new 

       20,000  

        35,000  

        50,000  

Safety report – update 

       15,000  

        17,000  

        20,000  

IEP- new 

          6,000  

          8,000  

        10,000  

IEP – update 

          3,000  

          4,000  

           5,000  

Source: Final Report on Modules 3&4 for Environment Priority Area July 2009 - part of an EU (DG ENT) project on 

baseline measurement and reduction of administrative costs (which included the Seveso II Directive). 

It should be noted that the costs above are unit costs per event and therefore higher than the 
annual average unit costs displayed in the previous table. 

Non-administrative compliance costs 

Should an establishment become a Seveso II site they might need to undertake investments in 
changes  to  their  manufacturing  process  or  to  the  way  they  store  chemical  substances.  As 
discussed earlier, such costs are difficult to estimate 

Such costs are difficult to estimate due the following factors: 

•  They are very site-specific and they vary with an order of magnitude; 

•  There is other legislation, both at EU and Member State level, for example  regulations 
addressing worker protection, product/equipment safety, industrial emissions, etc, that 
might lead an establishment to invest in physical changes to equipment and installations 
to reduce the risk of a major accident. 

•  The level of safety systems in each Member State 

The kinds of modifications that a site might need to invest in could include: 

•  Equipment to monitor processes and storage facilities; 

•  Additional storage capacity; and 

•  Containment infrastructure to prevent liquids leaving the site. 

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The costs of such investments will depend on the size and complexity of the establishment, 
the nature of its operations, and the hazard potential.  

There  are  a  few  studies  that  have  looked  at  the  non-administrative  costs  under  the  heading  of 
control  costs.  These  studies  cover  the  costs  for  UK  industries  of  adapting  to  the  Seveso 
requirements as they are implemented in the UK's COMAH regulation.  

In the Regulatory Impact Assessment(RIA)18 - made when implementing the 2003 amendments to 
the  Seveso  Directive  -  it  is  argued  that  the  status  of  these  control  costs  are  uncertain  and  they 
show cost results both with and without the control costs. The main argument was that some of 
these costs in reality would have been incurred due to other legislation. 

The  control  costs  were  assessed  in  two  studies19  -  the  later  also  providing  a  review  of  the  data 
used in the first study. The combined results suggest that the costs for upper tier establishments 
are  in  the  same  order  as  the  administrative  costs.  For  lower  tier  establishments  there  is  a  large 
variation  in  the  results  of  the  two  surveys  and  they  could  vary  within  a  range  of  5%  of  the 
administrative costs to be at the same order as the administrative costs.  

The  above  discussed  control  costs  relate  the  UK  industry  adoption  of  the  Seveso  requirements 
around 10 years ago. If the level of health and safety management in the European industry has 
generally improved, the costs for a non-Seveso site to enter within scope of the Directive today 
might be less than it was 10 years ago. 

In addition to these factors making the data on physical compliance costs uncertain, there is also 
the  potential  financial  benefits  to  consider.  Savings  from  reductions  in  the  frequency  of  minor 
incidents that typically lead to loss of production would be such a benefit. This element has not 
been considered in detail in the studies on the control costs. 

On the basis of these data it is not possible to provide a sufficiently solid estimate to be used 
in  this  analysis.  However,  they  suggest  that  the  non-administrative  costs  would  be  at  the 
maximum the same as the administrative costs. 

It is also important to note that for nearly all of the specific amendment issues covered in this 
impact assessment study, the proposed changes will not affect the number of establishments 
and the options will have no or very limited impacts on the physical conditions at the sites and 
therefore not lead to physical compliance costs. 

Industry adaptation to threshold 

It is sometimes reported that companies adjust their stocks of substances to quantities below 
the  relevant  thresholds  and  thereby  avoid  coming  within  scope  of  the  Directive.    Such 
behaviour implies costs, but it is assumed that such downsizing only happens if the costs are 
less that the compliance costs of being within scope of the Directive. For options that could 
imply  a  change  in  scope,  no  adjustment  is  made  for  this  effect  that  could  lead  to  fewer 
changes  to  the  number  of  establishments  within  scope  of  the  Directive.  Therefore,  by  using 

18 UK (2005) Regulatory Impact Assessment (final) of the 2003 amendments to the SEVESO Directive 
19 HSE 2003 Safety report regime - evaluating the impact on new entrants to COMAH, study by Entec UK Ltd 

for HSE. 

HSE 2006, "Impact evaluation of the Control of Major Accident Hazards(COMAH) Regulations 1999" by Risk 

Solutions for the Health and Safety Executive 2006 

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the costs per establishments as presented above, the overall cost assessment will in principle 
overestimate the costs as some companies might find it cheaper to adjust stocks or production 
volumes. 

The effect on the protection level of such behaviour is difficult to assess. If it leads to overall 
fewer  sites  holding  dangerous  substance,  then  it  is  positive;  otherwise  it  could  lead  to  a 
decrease if sites are not taking the necessary measures to reduce the risk of major accidents. If 
such  behaviour  leads  to  more  transport  of  substances,  this  is  likely  also  to  decrease  the 
protection  level  though  transport  activity  is  also  subject  to  specific  legislation  regarding 
transport of dangerous goods.  

Adaption  through  supply  chain  management  to  the  Seveso  thresholds  can  have  unwanted 
effects, but it is difficult to avoid such behaviour as it is necessary to define thresholds in the 
Directive.  

SMEs 

The  impact  of  the  amendment  options  could  be  significantly  different  for  SMEs  compared 
with  other  operators.  The  general  situation  with  regard  to  impacts  of  Seveso  in  SMEs  is  as 
follows. 

There are no exact data on the share of SMEs out of the about 10,000 establishments currently 
covered by the Seveso II Directive. About half of the establishments are lower-tier, but this 
does not necessarily mean that a lower-tier site typically is an SME.  

An industry questionnaire as part of the EU-VRi study included respondents also from SMEs. 
Out  of  102  respondents  16  were  from  SMEs20.  As  this  was  a  web-survey,  it  is  not  a  very 
precise indicator for the share of SMEs.  

The  industry  survey  also  covered  the  question  of  specific  implementation  issues  for  SMEs. 
The results suggested that guidance and other forms of support to the implementation of the 
Directive are particularly important for SMEs. There were also references to the cost burden 
being high for SMEs, but there were no further data included in the study to assess or validate 
these statements.  

The  data  from  the  metal  finishing  industry  provides  an  example  of  SMEs  being  upper-tier 
establishments,  at  least  in  some  Member  States.  The  industry  association  argues  that  the 
Seveso  requirements  comprise  a  significant  burden  on  the  industry.  They  quote  numbers 
where the annual Seveso costs amount up to several percentage points of the annual turnover.  

Using the unit administrative costs as presented above, a rough assessment can be made. The 
estimated  annual  cost  is  the  order  of  5,000  EUR  for  lower-tier  sites  and  this  would  be 
equivalent to 0.5 % of total turnover for a company with a turnover of 1 million EUR. If the 
profit  rate  of  such  a  company  is  assumed  to  be  10%  of  turnover,  the  administrative  costs 
would be 5% of the profit. On its own, this not a high burden, but combined with many other 
pieces of legislation it could an issue for certain SMEs.  

20 EU-VRi (2008) Study of the effectiveness of the SEVESO II Directive, August, pp.44-45 

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If  the  SME,  as  in  the  case  of  the  metal  finishing  industry,  is  in  many  cases  upper-tier,  and 
using an average value of 30,000 EUR, the share of Seveso costs in turnover is around 3% as 
quoted by the industry and using the assumption of profit of 10% of turnover, the costs for an 
upper-tier SME could be of the order of 30% of the company profit. 

Total costs of the Seveso II Directive 

It  is  relevant  to  be  able  to  compare  the  changes  in  costs  that  could  results  from  the 
amendments being considered in this impact study to the total costs of the Directive. 

The  total  costs  have  not  been  subject  of  any identified  study.  Various  previous  assessments 
have addressed certain aspects. The Administrative Burden study provides an estimate of the 
administrative  costs  to  industry  (operators).  Compliance  costs  in  physical  modification  are 
very  difficult  to  assess  as  described  above.  The  Admin  Burden  study  estimates  the  total 
administrative costs of Seveso II to be in the order of 52 million EUR.  

The  costs  to  the  competent  authorities  have  not  been  directly  assessed.  The  study  on  the 
effectiveness  of  implementation21  includes  replies  a  number  of  respondents  on  the  average 
man-years  used  for  Seveso  in  the  organisation  they  represent.  In  most  Member  States  there 
are  several  organisations  that  have  a  formal  role  in  the  implementation  of  the  Seveso  II 
Directive.  By  assuming  an  average  number  of  organisations  with  responsibilities  in  the 
implementation,  it  is  possible  to  make  a  rough  estimate  of  the  total  costs  for  competent 
authorities in Member States.  

Based on ERM (2009), the average man-year per organisation can estimated to roughly 5 and 
assuming  that  there  are  3  organisations  involved  in  each  Member  State  the  total  number  of 
man-years  is  about  400.  Assuming  an  average  day  rate  for  experts  of  500  EUR,  the  total 
annual costs would be the order of 40 to 50 million EUR.  

The  UK  RIA  referred  to  above  also  includes  an  assessment  of  the  implication  to  the 
competent  authorities  authorities  involved  -  for  example  the  emergency  services.  The  data 
indicate costs per establishment of in the order of 10k EUR per year and 40k EUR per year 
respectively for lower and upper tier establishments. This suggests total costs for competent 
authorities  and  other  public  authorities  in  the  same  order  or  even  higher  than  the 
administrative  costs  for  the  operators.  Applying  these  estimates  to  provide  EU  wide  costs 
would  most  likely  be  an  overestimation  as  the  UK  costs  are  higher  than  the  EU  average.  It 
suggests though that the above estimate of 40-50 million EUR is at the lower end and that the 
costs to Member States competent authorities could be higher. 

This leads to an overall estimate of the total administrative costs to both industry and CAs to 
be at least in order of 100 million EUR.  Though it should be emphasised that this is only an 
order  of  magnitude  estimate,  it  provides  nevertheless  a  basis  for  assessing  the  cost  of  the 
various amendments.  

Administrative cost impacts estimates used for policy issue 1 (Seveso Annex I alignment)  

All estimates and assumptions are taken from the COWI Impact Assessment Studies. 

21  ERM  (2009)  Seveso  II  Directive  -  Study  of  the  Effectiveness  of  the  Requirements  Imposed  on  Public 

Authorities 

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COWI used the following general assumptions to calculate the cost impacts for industry: 

o  Establishments that are already Seveso II sites might not experience much cost savings as 
a result of the changed status. They have already invested in safety reports, safety systems 
and  emergency  plans  and  in  physical  modifications,  if  those  were  necessary.  They  will 
only save on future updates of the plans.  

o  Review notification/safety report: The costs of such reviews are difficult to estimate. Only 

purely illustrative calculations can be used with the following assumptions: 

o  The  reclassification  process  already  started  should  be  regarded  independently  from  the 

Seveso adaptation to the CLP and is not included in these cost estimates, 

o  Technical protection measures are in place and no investment in technology, construction 

etc. is necessary,  

o  Overall costs are incurred reviewing existing inventories, reviewing and understanding the 

new Annex 1 and notifying changes 

o  There is likely to be asymmetric effects so the cost savings for one establishment falling 
out  of  scope  will  not  offset  the  additional  costs  for  a  new  establishment  coming  into 
scope. The total aggregated costs could therefore increase, even if there is no net increase 
in the number of establishments falling within scope.   

o  Each  company  spends  one  to  three  days  on  reviewing  the  substance  and  mixture 

inventories (average 1.5 days) in addition to the CLP motivated reviews;  

o  The  number  of  non-Seveso  II  establishments  that  need  to  make  reviews  in  order  to 
determine if they might fall within scope is assumed to be 50% of the number of Seveso II 
establishments; 

o  The total number of Seveso II establishments is approximately 9725 and these will need to 

review their inventories; 

An average annual day costs is assumed to be EUR 350. 

For policy option 1, 3 types of costs have been considered: 
1) CLP adjustment costs for all establishments; 
2) General adaptation costs for such establishments using toxic/very toxic substances 
3) Change of scope costs/savings. 

1) All Seveso operators have to review their inventories in the light of the new Annex I and 
provide  information  about  the  CLP  adjusted  substances,  mixtures  or  categories  to  the 
authorities. For all Seveso establishments and for all hazards, the total one-off Seveso-related 
CLP adjustment costs for reviewing inventories have been estimated for operators at around 
1.7 Million EUR (7.6 Million annualised over 5 years at 4%), which represents an average of 
around  200  EUR  per  establishment,  per  year.  In  addition  to  the  costs  for  industry,  the 
adjustment costs for authorities would be around 400.000 EUR per year (1.8 Million over 5 
years).  

2)  The  costs  for  the  general  adaptation  have  been  taken  from  COWI's  Impact  Assessment 
Study.  COWI has estimated the general adaptation costs for option D as 1,700,000 Euro and 
for  B  and  C  (with  differentiation  of  exposure  routes)  as  2,900,000  Euro.  The  figure  for 
options C and D have been taken, and the figures for E and E* estimated as 2,000,000 Euro, 
in between C and D, but closer to D.  

3) The change of scope costs/savings in this assessment are based on the COWI figures, but 
had to be modified due to the following two reasons:  Firstly, COWI has not assessed in detail 
options  E  and  E*,  and  second  and  more  importantly  s  the  COWI  options  C  and  D  were 

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calculated with a compensation mechanism of named substances, leading to different numbers 
of establishments, and accordingly to different costs related to the change of scope.  

The costs for a change in scope have been calculated by COWI as follows, for  

•  A reduction of 88 sites (-54 lower tier, -34 upper tier) to -1,300,000 Euro, and  

•  An extension of 133 sites (65 lower tier, 68 upper tier) to +2,400,000 Euro. 

•  A reduction of -342 sites (-206 lower tier, -136 upper tier) to -5,100,000 Euro. 

The  costs  for  upper  establishments  coming  newly  under  Seveso  are  estimated  with  annual 
costs  of  around  30,000  EUR  and  for  lower  tier  establishments  of  around  5,000  EUR. 
Establishments already Seveso II sites might not experience much cost savings as they have 
already invested in safety reports, safety systems and emergency plans. They will only save 
future updates of plans. Therefore the cost savings are only estimated of around 50 % of the 
change of scope costs (15,000 EUR and 2,500 EUR respectively). The distribution between 
lower  and  upper  tier  sites  is  roughly  50/50;  the  exact  distribution  for  each  area  assessed  is 
included in Annex VII.  

Taking into account the similarities, this IA report comes to the following figures  

Option 

General 
adaptation (1) 

Change in scope costs (2) 

a) T+ 
alignment 
b) T alignment 

b) T alignment 
excluded sites 

b) T alignment  
newly included sites 

C 

D 

E 

E* 

2.9  

1.7  

2 

2 

-2.5 

-2.5 

-2.5 

-2.5 

-0.1 

- 

-0.8 

-0.8 

+2.2 

+5.7 

+0.2 

+3.7 

Short explanation per option:  

•  Option C: Adaptation costs: same as COWI; Scope change -2%, Annual savings 

for 324 sites, costs for 131 new sites; 

•  Option D Adaptation costs: same as COWI, Scope change +0.3 %: ~ 1/3 COWI 

option D, Annual savings for 314 sites, costs for 342 new sites; 

•  Option  E:  Adaptation  Costs  slightly  higher  than  D,  but  lower  than  C 
(differentiation exposure routes, but no differentiation within Inhalation); change 
in scope savings for 415 sites costs for 10 new sites; 

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•  Option E*: Adaptation Costs same as for E, change in scope savings for 405 sites, 

costs for 221 new sites. 

Competent Authorities 

Authorities  will  have  one-off  costs  of  adapting  to  a  revised  Annex  I  (review  notifications; 
update, control/translation of chemicals databases and IT). To estimate how much time each 
CA  will  use  on  such  a  one-off  review  of  the  implications  of  the  changes  to  the  Directive. 
Using the following assumptions, a rough estimate can be made: 

Each  Member  State  would  spend  about  50  days  to  review  the  necessary  changes  to 

• 
national implementation;  

The CAs would then use one day to review site-specific Seveso II permits for 40% of 

• 
all Seveso II establishments (i.e. about 3900); 

• 

An average annual day costs is assumed to be EUR 350. 

The  effort  that  the  transition  to  the  CLP  legislation  will  imply  could  possibly  be  reduced  if 
more tools were available. Harmonised translation tables or even electronic translation tools 
would  reduce  the  administrative  costs.  They  would  not  include  all  the  self  classified 
substances but still could be a useful measure to reduce the administrative burden.   

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ANNEX IX 

Costs and benefits of options for Policy Issue 3: Procedures for adapting Annex I in the 
future  

For more information about the basis for the cost calculations please refer to section 3.1 of the 
COWI impact assessment study (7). 

Costs and benefits of Option (a): Unchanged policy 

The no-change option could lead to new substances being included in scope which present no 
major  accident  hazard.  Given  the  limited  scope  of  the  existing  derogation  rule  (see  below), 
this could lead to significant additional costs, although it is difficult to quantify these. If it is 
assumed that there are 20 such substances, and their inclusion under the scope of the Directive 
would  increase  the  number  of  both  lower  and  upper  tier  establishments  by  5%,  this  would 
equate  to  about  250  lower  and  upper  tier  establishments.  Based  on  the  administrative  cost 
assumptions in Annex VIII and applying a cost of 5,000 and 30,000 EUR per lower/upper tier 
establishment per year as average administrative costs, the total annual costs would be around 
8  million  EUR  for  industry  (plus  800,000  EUR  for  competent  authorities).    However  this 
assumes  that  the  establishments  concerned  only  fall  into  scope  because  of  those  new 
substances  and  are  not  already  caught  because  of  other  substances  in  their  inventory.  There 
would be no impact on protection levels. 

The no-change option would also mean that amendments to Annex I would continue to be via 
co-decision,  which  could  entail  significant  administrative  costs  for  Member  States,  the 
Commission and the co-legislators. In cases where a substance should be added to Annex I, 
the protection level (environmental, health and social) could be adversely affected due to the 
length of time needed for possible amendments to the Annex I to be adopted. 

Costs and benefits of Option (b): Extend scope of existing derogation rule 

This  option  would  give  rise  to  increased  costs  for  industry  and  competent  authorities  in 
dealing with derogation requests, but it is difficult to quantify these. The benefits in terms of 
savings  for  operators  would  depend  on  how  far  the  scope  of  the  derogation  was  extended 
beyond  information  requirements  in  relation  to  the  safety  report,  but  would  be  less  than 
options (c) and (d). There would be no change in protection levels. 

There  would  need  to  be  strict  adherence  to  the  harmonised  criteria  in  order  to  ensure  that 
operators are treated equitably so that there is no risk of possible distortions to competition. 

Costs and benefits of Option (c):  general derogation rule at EU level 

The  costs  of  this  option  would  be  the  administrative  costs  for  industry,  the  competent 
authorities and the Commission in dealing with derogation requests. It is estimated that that 
these would be about 300,000 EUR per annum. However such costs could be more than offset 
by the benefits in terms of savings from any derogations that resulted in establishments being 
exempted.  The  option  would  bring  benefit  in  terms  of  bringing  greater  flexibility  to  the 
Directive’s application. There would be no change in protection levels.  

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Costs and benefits of Option (d):  general establishment specific derogations at Member State 
level 

The potential costs and benefits of this option would be potentially greater than for option (b), 
but  are  difficult  to  estimate.  It  would  allow  greater  flexibility  in  the  application  of  the 
Directive at Member State level but the risks of possible distortion to competition would also 
be greater so there would need to be close monitoring to ensure that the criteria were being 
respected. 

Costs and benefits of Option (e):  safeguard clause 

The  impacts  will  depend  on  how  often  such  a  clause  is  used.  In  any  specific  use  of  such  a 
clause, the benefit will be an increased protection level for human health and the environment. 
The  costs  will  be  the  compliance  and  administrative  costs  for  industry  and  the  competent 
authority.  

The benefits of using delegated acts to effct changes to annex I from application of options (c) 
and  (e)  would  be  increased  speed,  flexibility  and  efficiency  in  amending  Annex  I.  The 
administrative  cost  would  be  relatively  limited  since  the  task  would  be  taken  up  by  the 
Commission  using  existing  consultation  procedures.  The  protection  level  would  remain  the 
same or slightly increase. 

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ANNEX X 

Costs and benefits of options for Policy Issue 4: Information to the public and 
information management systems including reporting  

For more information about the basis for the cost calculations please refer to section 3.1 of the 
COWI impact assessment study (7). 

A) Options for type of information provided 

Costs and benefits of Option (a): Unchanged policy  

This  no-change  option  would  impose  no  additional  costs  on  operators  or  public 
authorities and bring no improvements in information provision. 

Costs and benefits Option (b): Annex V information made available on line 

This option goes beyond the existing situation by requiring that information currently 
covered by Annex V should be available online.  

As  all  Member  States  can  be  assumed  to  have  governmental  websites  where  this 
information could be placed, no further data management system would be needed. 
Moreover  since  this  information  should  be  produced  already  there  should  be  no 
significant additional costs to competent authorities or operators. For operators it  is 
estimated  that  the  total  one-off  costs  would  be  about  1  million  EUR.  Maintenance 
costs would be limited 

The benefit of this option would be that it would be easier for the public to access the 
information  and  easier  for  each  competent  authority  to  monitor  that  it  is  actually 
available.  

Costs and benefits Option (c): Additional information  

This would extend the Annex V requirement in two ways. Firstly, basic data such as 
name, location and activity for all establishments would be included.  Secondly, for 
all upper-tier establishments, information would be included about the main type of 
major accident scenarios and the events that could trigger each of these scenarios as 
well as appropriate information from the external emergency plan.  

The former would not entail any significant additional costs since this information is 
produced already and submitted to the Commission's SPIRS database. For the latter, 
it is estimated that there would be total one-off costs of 2-4 million EUR to produce 
such information for all upper-tier establishments. The annual costs of updating the 
information would be about 0.5 million EUR. 

In addition to the benefits of option b), this option would ensure that some clear basic 
information  about  the  nature  of  the  accidents  hazards  and  information  on  how  to 
behave in case of an accident is provided. This is likely to facilitate a more adequate 
response in case of a major accident taking place and thereby reduce the impacts of 
such  accidents. It could also help  operators  and competent authorities draw lessons 
from the best practices of others. 

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Costs and benefits Option (d): Additional information plus non-technical summaries 
of key documents 

This option would add to option c)  by requiring in addition non-technical summaries 
of  the  key  documents,  the  safety  report,  the  internal  and  the  external  emergency 
plans, to be made publicly available.  

It  is  estimated  that,  assuming  that  non-technical  versions  of  all  three  documents 
would cost around 10% of the costs to produce the full technical documents, the total 
one-off costs for all upper-tier establishments could of the order of EUR 20 million 
(of  which  EUR  3  to  4  million  would  be  costs  for  competent  authorities)  assuming 
that  no  such  documents  are  currently  produced.  On  the  assumption  that  the 
information  would  need  to  be  updated  every  three  years,  the  average  total  annual 
costs of updating the material would be around EUR 2-5 million. 

The  additional  benefit  of  this  option  compared  with  option  c)  is  that  this  more 
detailed  information  from  the  non-technical  summaries  will  further  increase  the 
population's  awareness  of  the  possible  risk  scenarios  and  the  of  the  need  to 
understand  and  follow  the  advice  included  in  the  emergency  plans.  Furthermore,  it 
will generally inform the interested public about major accident potential issues. 

Other impacts of options (b) to (d) 

Underlying these options is the need to ensure that the provisions, including those in 
Article  20  of  the  Directive  on  confidentiality,  are  brought  into  line  with  the 
provisions  of  Directive  2003/4/EC  on  public  access  to  environmental  information. 
(Likewise the provisions on public consultation in the context of the development of 
external emergency plans and land-use planning procedures need to be brought into 
line with Directive 2003/35/EC on providing for public participation in respect of the 
drawing  up  of  certain  plans  and  programmes  relating  to  the  environment).  At  the 
same time transparency and openness needs to be balanced against security and other 
confidentiality concerns. 

The  more  information  that  the  public  should  have  access  to,  the  more  effort  is 
required  in  defining  in  each  case  where  the  balance  lies,  which  could  potentially 
increase  the  costs,  particularly  for  competent  authorities.  It  is  very  difficult  to 
estimate  these  costs  as  it  depends  on  how  many  establishments  there  are  where 
confidentially  and/or  security  issues  are  significant.  Moreover  these  costs  are  not 
necessarily  additional  costs  as  Member  Status  should  already  be  making  such 
assessments. 

Another  possible  impact,  which  cannot  be  quantified,  is  that  detailed  information 
could reduce the prices or property neighbouring Seveso sites. It could also generate 
public pressure to reduce the risks or to re-locate certain establishments.  

B) Options for information management 

Costs and benefits of Option (a): Unchanged policy 

This  no-change  option  would  maintain  the  status  quo,  with  the  generally  fairly 
limited  on-line  systems.  It  thus  imposes  no  additional  costs  on  operators  or  public 
authorities and brings no improvements. 

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Costs and benefits of Option (b): Member State databases 

This  option  would  require  all  Member  State  to  have  a  system  that  allows  public 
access to relevant information for each establishment.  

Given  that  establishing  this  would  require  only  a  simple  website  structure  and 
uploading  relevant  documents  and  information  for  each  establishment,  this  should 
not  entail  significant  resources.  It  is  estimated  that  do  this  the  total  one-off  costs 
would be about 1 million EUR. Maintenance costs would be limited. 

The benefit of this option would be that it would facilitate the online availability of 
options (b) to (d) in part A) above in relation to the type of information to be made 
publicly available. Having to upload information for each establishment will make it 
easier  for  Member  States  to  monitor  that  this  information  (which  is  required  to  be 
publicly  available)  actually  exists  and  is  available.  In  principle  it  should  therefore 
help to reduce enforcement costs once the system is in place, though this benefit can 
not be quantified. 

If  such  a  database  also  included  information  relevant  for  the  purposes  of  Member 
States'  implementation  reports  pursuant  to  Article  19.4,  this  could  facilitate  and 
streamline such reporting. 

Costs and benefits of Option (c): central EU wide database version 1 

This option would establish a central website that can be used to access information 
in all Member States either through links to documents directly uploaded on to it or 
links to Member State websites/databases.  

Establishing a central database as described here would not be very costly as it used 
existing  it  infrastructure  and  existing  databases.  If  links  or  documents  need  to  be 
made/uploaded  for  all  10,000  establishments  and  it  will  take  an  hour  for  each 
establishment, the total set-up costs would be around 0.5 and one million EUR. The 
operation and maintenance costs would depend on how frequent the database should 
be checked - probably half to a full man year per year would sufficient which could 
cost about 50,000 to 100,000 EUR per year. 

In  addition  to  the  benefits  of  option  (b),  it  has  the  added  benefit  that  it  will  make 
sharing of relevant information more efficient. Not only will it provide easier public 
access  to  the  information,  it  will  also  support  the  competent  authorities  in  their 
activities. 

Costs and benefits of Option (d): central EU wide database version 2 

The option of centralised database with all information integrated within it would be 
a  more  resource  intensive  solution  and  would  necessitate  Member  States  adapting 
their existing systems.   

The  specific  costs  of  such  an  approach  cannot  be  estimated  without  a  detailed 
analysis of the system requirements, but are likely to be very substantial. 

The benefits of this option would be the same as option (c). 

EN 

96 

   EN 

 
Other impacts 

Options  (b)  to  (d)  would  provide  a  structure  that  could  help  to  simplify  and 
streamline  Member  States'  implementation  reporting  pursuant  to  article  19.4  of  the 
Directive. 

EN 

97 

   EN 

 
ANNEX XI 

Costs and benefits of options for Policy Issue 6: clarifications to facilitate effective 
implementation  

A)  Closer coordination, integration of information and procedures, etc 

See section 5.6.2 of this report 

B)  Other issues where clarifications are needed 

Safety performance indicators 

For further information about SPIs and the effects of using them, cots etc please refer 
to section 5.6.1 of the COWI impact assessment study (7). 

Costs and benefits of Option (a): Unchanged policy 

This  would  have  no  impact  on  costs  or  the  level  of  protection  compared  with  the 
current situation. 

Costs and benefits of Option (b): Mandatory requirements 

Making SPIs mandatory will lead to costs of developing and implementing the right 
SPIs at each site. If it is possible to define a standard set of the right SPI that can be 
immediately applied these costs for each site could be reduced but then there will be 
costs  for  CAs  and  the  Commission  in  developing  such  a  standard  set  of  the  right 
SPIs.  There  could  be  some  benefit  in  terms  of  improving  protection  levels,  by 
increasing the focus on safety culture and management. Costs and benefits of Option 
(c): Non-binding requirements 

This  option  would  be  less  costly  since  the  use  of  SPIs  would  be  optional.  It  could 
potentially  have  the  same  benefits  as  option  (b)  but  would  provide  flexibility  to 
Member States. 

Costs and benefits of Option (d): Guidance 

This  option  would  not  be  costly  as  the  work  could  be  contained  within  existing 
administrative  costs.  Guidance  could  help  to  improve  the  use  of  SPIs  and  help 
contribute towards improved protection levels 

Domino effects 

Costs and benefits of Option (a): Unchanged policy  

There  would  be  no  impact  on  costs  or  protection  levels,  which  would  however  be   
less than optimal. 

EN 

98 

   EN 

 
Costs and benefits of Option (b): Include additional requirements 

Under  this  option,  there  would  be  clearer  obligations  in  Article  13,  relevant    
provisions   in Article 6(notifications) and Annex II (safety report) to take account of 
external factors and possible domino effects.   

The  costs  are  likely  to  be  low  assuming  that  operators  already  consider  external 
factors.  Improved  dissemination  of  information  to  non-Seveso  sites  should  not  be 
resource demanding and will be part of the general improvement to the provision of 
information to the public. 

The  impact  on  the  protection  level  is  difficult  to  assess  due  to  the  lack  of  data  in 
relation to domino situations, but is likely to be positive. 

Underground gas storage sites 

Costs and benefits of Option (a): Unchanged policy  

The  no-change  option  would  have  no  impacts  in  terms  of  costs  or  benefits.  The 
present  uncertainty  over  whether  such  sites  are  caught  by  the  Directive  would 
remain, resulting in differences of treatment between Member States. 

Costs and benefits of Option (b): Include within scope of Directive 

According to a Commission survey in 2008, in total there are about 150 underground 
gas  sites  in  the  EU,  of  which  100  are  already  covered  national  legislation 
implementing the Directive. 

The economic impact of including the remaining 50 sites would be in order of EUR 
1.5 million annually assuming that all sites would become upper tier establishments. 
(Currently around 90 per cent of the sites qualify as upper tier establishments).      

The  benefits  of  this  option  are  there  would  be  a  level  playing  field  for  all 
establishments.  Furthermore  the  protection  level  would  be  increased  given  the 
significant major accident hazard potential associated with underground gas storage 
facilities. 

Environmental effects 

Costs and benefits of Option (a): Unchanged policy 

The  no-change  option  would  have  no  impact  on  costs  or  benefits.  There  would 
remain a potential gap in terms of the level of protection. 

Costs  and  benefits  of  Option  (b):  Include  more  details  in  Annex  II,  Annex  IV  and 
Article 12 (land-use planning) 

This  option  has  three  separate  components  involving  inclusion  of  more  specific 
references  to  environmental  aspects  as  follows:  in  the  safety  report  (Annex  II);  in 
emergency planning (Annex IV) and land-use planning (Article 12). 

These options are not alternatives and are assessed together. 

EN 

99 

   EN 

 
To the extent that environmental aspects are not already being addressed, there could 
be  slight  increases  in  costs  as  regards  developing  and  updating  safety  reports  and 
emergency  plans.  The  impact  on  costs  in  relation  to  land-use  planning  could  be 
higher  in  terms  of  additional  time  and  resources  needed  to  make  environmental 
assessments  and  possible  physical  mitigation  measures,  but  these  cannot  be 
quantified. 

All the components would increase the protection level in relation to environmental 
impacts. 

Deadlines for External emergency plans 

Costs and benefits of Option (a): Unchanged policy 

The  no-change  option  would  have  no  cost  implications  or  impact  on  the  existing 
level of protection. However the lack of any specific deadline for completion of the 
plans has give rise to delays which could have a major adverse impact on as a result 
of reporting. 

Costs and benefits of Option (b): Specify a 12 months deadline 

This would not involve any additional costs since external emergency plans have to 
be  developed  in  any  case.  There  would  be  a  positive  impact  on  the  level  of 
protection. 

Reporting of accidents 

Costs and benefits of Option (a): Unchanged policy 

No  clear  data  are  available  on  the  costs  to  operators  and  competent  authorities  of 
reporting accidents, but these are not significant. The no-change option would have 
no impact on these costs or the existing level of protection as a result of reporting. 

Costs and benefits of Option (b): Deadline for reports 

Since reports have to be submitted anyway, imposing a deadline would not have any 
impact  on  costs.  This  option  has  the  benefit  that  it  would  speed  up  reporting  and 
could  lead  to  improvements  in  the  protection  level  through  early  dissemination  of 
lessons learned from accidents. 

Costs and benefits of Option (c): Reduced reporting threshold 

If the current threshold were to be reduced to 5% of the lower tier thresholds or 1% 
of  the  upper  tier  thresholds,  it  would  reduce  the  threshold  by  a  factor  of  4-5.  For 
example, the difference between LT and UT thresholds varies by a factor of 2 to 10; 
for most hazard categories it is around 4. It is estimated that such a reduction could 
lead  to  an  additional  20  major  accidents  being  reported  (compared  with  an  annual 
average  of  around  30  at  present),  with  a  corresponding  increase  in  costs,  though 
overall these would remain moderate(according to the administrative burdens study 
the total annual costs for operators of reporting accidents is 47,000 EUR) 

EN 

100 

   EN 

 
The  benefit  of  this  option  is  that  if  more  accidents  are  being  reported,  this  will 
increase  knowledge  and  lessons  learned,  which  should  ultimately  help  to  improve 
prevention of similar accidents and lead to higher levels of protection. 

Safety management requirements for lower-tier establishments 

Costs and benefits of Option (a): Unchanged policy 

The  no-change  option  would  have  no  impacts  in  terms  of  costs  or  benefits.  The 
present  uncertainty  over  interpretation  of  Annex  III  would  remain,  resulting  in 
differences of treatment between Member States. 

Costs and benefits of Option (b): Clarify existing text of Annex III 

This option would clarify that an SMS should be proportionate to the hazards (and 
that this should be reflected in the underlying documentation and procedures). This is 
unlikely  to  have  much  impact  on  costs.  It  should  make  implementation  easier  and 
could  reduce  for  competent  authorities  and  industry  by  avoiding  questions  and 
clarifications  about  the  content  of  the  MAPP  and  its  relationship  to  the  SMS. 
However  it  would  also  allow  those  Member  States  who  impose  stricter  rules  to 
continue to do so. There is unlikely to be any impact on protection levels. 

Costs and benefits of Option (c): Require full safety management system  

There  are  no  data  available  on  the  specific  costs  of  introducing  a  SMS  so  it  is 
difficult  to  quantify  the  costs  of  this  option.  However  these  could  be  quite 
substantial. 

 It is estimated that about two thirds of the Member States already have requirements 
similar to SMS for lower tier establishments. However these requirements are often 
proportionate to the size of the establishment, degree of risks etc. Moreover the level 
of  safety  management  systems  varies  across  establishments.  This  means  that  those 
that  might  already  have  formulated  a  SMS  could  incur  limited  additional  costs, 
whereas  those  that  do  not  have  any  formalised  safety  system  would  need  to  set  up 
and document a SMS, which could take a lot of time and resources. 

The  benefit  of  this  option  is  that  protection  levels  would  increase  since  safety 
management  systems  make  a  significant  contribution  towards  enhancing  safety. 
However extending the requirements for lower-tier establishments in this way would 
undermine  the  principle  of  proportionality  in  the  existing  two-tier  approach  of  the 
Directive. 

Costs  and  benefits  of  Option  (d)  mini-safety  report,  including  internal  emergency 
plan 

Preparing a safety report is one of the most expensive administrative requirements. 
One  of  the  important  elements  of  the  safety  report  is  the  work  of  defining  and 
analysing major accidents scenarios, which can be a resource-intensive exercise.  

EN 

101 

   EN 

 
 
As a minimum, to be of use a min-safety report would need to be based on one or 
two major accident scenarios.  

It is roughly estimated that the costs of such "mini" safety report would be between 
25%  and  50%  of  the  costs  of  a  full  safety  report  (the  average  cost  of  which  is 
estimated as 35,000 EUR). If the lower percentage is used, the best estimate for the 
average  costs  of  preparing  a  mini  SR  is  about  8,750  EUR.  An  equivalent  "mini" 
internal emergency plan is estimated at EUR 2000. In total these administrative costs 
will  be  10,750  EUR  per  lower  tier  site.  Based  on  a  survey  of  existing  national 
requirements,  it  is  assumed  that  50%  of  the  Member  States  (and  establishments) 
already  have  similar  requirements  for  lower  tier.  So  the  estimated  total  additional 
one-off cots of this option are 25 million EUR. 

There would be increased benefits in terms of the level of protection compared with 
option  (c).  However  it  would  also  have  the  same  disadvantage  of  undermining  the 
existing two-tier approach. 

Costs and benefits of Option (e): Combination of options (c) and (d) 

This would imply significant additional costs compared with the other two options. 

Protection levels would be even further increased, but the existing two-tier approach 
would  be  completely  nullified,  there  being  effectively  no  longer  any  distinction 
between upper- and lower-tier sites. 

The following table summarises the impacts of alternative options (b) to (e): 

Overview of impacts of lower tier options  

Clarify the text in the Directive 

LT in %1 
of full 
Na 

Cost per lower 
tier in EUR 

Total costs in 
EUR 
Possible marginal 
savings 
Potentially high 

Protection level 

No impact 

100% 

Potentially  high 

Extend full SMS requirement (as described 
in Annex III) into LT 
Require 'Mini' safety report including IEP 
for LT 
Require SMS, IEP and mini SR for the LTs 
(combination of the second and third 
options). 
1  Note 1): The costs of the LT requirement in % of the costs of the upper tier requirement e.g. costs of "mini" 
SR in % of SR.  

25 million one- 
off 
 > 25 million one-
off 

> 11,000 

10,750 

25% 

25% 

Increased 

Increased 

Increased 

The  impact  on  the  protection  level  from  increasing  lower-tier  requirements  is  difficult  to 
quantify. There is no consensus among Member States experts about whether risks are less for 
lower tier - some see little difference. As for the economic impacts where it is assumed that 
about 50% of the Member States already have additional requirement, also for the protection 
level some of the effect should already be realised and impact will be less than if no Member 
States  had  additional  requirements.  Overall  an  increase  in  requirements  that  prompt  better 
safety culture and systems should have an impact on the risks of major accidents, though it 
can not be quantified. 

EN 

102 

   EN 

 
 
 
 
ANNEX XII 

Summary table options: 

Option component 

Protection level23  

Economic  
impacts, inc 
change of scope 
for policy issue 122 

Other impacts 
including 
simplification, 
administrative 
efforts, etc 

Policy Issue 1: Alignment of 
Annex I 

% Change of scope 
(economic impact) 

C 

D 

E 

E* 

-2% (Costs up to 
+2.5 million EUR) 

Small decrease 
(Exclusion of the 
dermal and inhalation 
vapour exposure 
routes) 

Higher 
administrative 
costs due to 
differentiated 
exposure routes  

+0.3% (Costs up to 
4.9  million  EUR 
per year) 

Small increase 
(Inclusion of Acute 
Toxic 3 complete)  

-4.2%  (Savings  up 
to 1.1 million EUR 
per year) 

Decrease 
(Exclusion oral and 
dermal exposure route 

Small decrease 
(Exclusion oral 
exposure route for 
Acute Toxic 3 )  

-1.9%  (Costs  up  to 
2.4  million  EUR 
per year) 

No change (Acute 
Toxicity categories 
1,2,3 intact)  

Slightly higher due 
to partly 
differentiated 
exposure routes  

Slightly higher  due 
to partly  
differentiated 
exposure routes  

Policy Issue 2: other technical 
amendments to Annex I 

Hydrogen: a) do nothing 

Hydrogen:  b) 
alleviation  by  doubling 
threshold 

to  grant  an 
the 

Heavy 
possible re-classification effect 

fuel  oil:  a)  accept 

Heavy  fuel  oil:  b)  avoid  the 
possible  effect  by 
listing  as 
named  substance  with  other 
petroleum products  

Neutral 

Unchanged 

Neutral/limited 
impacts 

Unchanged/slight 
decrease 

Neutral/limited 
impacts 

Unchanged/possible 
slight increase 

Neutral 

Unchanged 

22 Economic impacts are administrative costs. Non-administrative compliance costs, for example related to such 
physical  modifications  have  not  been  considered  as  they  are  very  site  specific  and  it  has  not  been 
possible to quantify these.  

23 The protection level aspect covers protection against environmental damage, against damage to human health 
and against damage to public and private property. Therefore the environmental and part of the social 
impacts follow directly the results regarding the protection level. 

EN 

103 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Option component 

a) 

Aerosols: 
approximation 
150/500) 

the 
proposal 

CLP 
of 

Aerosols: b) higher threshold 

Sodium  hypochlorite:  a)  accept 
CLP  re-classification  effect  for 
mixtures 

Protection level23  

Economic  
impacts, inc 
change of scope 
for policy issue 122 

+ App. 0. 5 million 
EUR per year 

Unchanged/ 
slightly increased 

Other impacts 
including 
simplification, 
administrative 
efforts, etc 

- 3 to 4 million 
EUR 

+ Up to 3.5 to 4 
million EUR per 
year 

Increased 

Sodium hypochlorite: b) 
exemption 

Neutral/limited 
impacts 

Unchanged 

Sets a precedent 

Policy Issue 3:Procedure for 
changing Annex 1 

3 a) Do nothing – no extension 
of existing derogation provision 

3 b)/d: Allow Member States to 
grant derogations from some or 
all Seveso requirements based 
on harmonised criteria  

3 c): Allow EU wide substance 
derogations from some or all 
Seveso requirements based on 
harmonised criteria 

3 e) Introduce Safeguard clause 

Policy Issue 4A – Type of 
information to the public24 

a) Do nothing – Information as 
currently required by Annex V 

b) Annex V information on-line 

No impact 

No impact 

Potential savings 
for industry and 
CAs 

No or low impact 
(condition for 
derogation) 

Unwarranted CLP 
effects not 
correctable 

Potential risk of 
market distortion  

Potential 
significant savings 
for industry and 
CAs 

Potential increase 
in scope  

No impact (condition 
for derogation) 

Allows flexibility 
in light of CLP  

Potential increase 

Allows flexibility 
in light of CLP  

No additional costs  No impacts 

Slight increase  

Better access to 
information 

One-off costs 
around 0.5 to 1 
million EUR  

50,000-100,000 per 
year in 
maintenance plus 
some Member 
State costs 

c)  Additional 
information  on 
basic  data  for  all  sites  plus 

One-off costs 
around 2-4  million 

Increase. 
Improvement in 

Better access to 
information.  Less 

24 Confidentiality issues will be considered (see discussion in section 2.4) 

EN 

104 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
  
Option component 

accident 
information 
emergency  planfor  upper 
(revised Annex V) on line 

scenarios  and  key 
external 
tier 

from 

Protection level23  

Economic  
impacts, inc 
change of scope 
for policy issue 122 

EUR 

information available  

Annual costs up 
0.5 million EUR 

d)  Additional  information  plus 
non-technical  summaries  of  SR 
and EEP on line 

One-off costs from  
up to 20 million 
EUR 

Increase. Significant 
Improvement of 
information available  

Annual costs of up 
to 2 million EUR 

Other impacts 
including 
simplification, 
administrative 
efforts, etc 

consequences in 
event of accident 
Aids lessons-
learning and 
exchange of best 
practices, 
monitoring of 
actual 
implementation 
etc. Improved, 
transparency.  

As above  

Policy  Issue  4B:  management 
of information 

a) Do nothing – continue with 
current Member States systems 

b)  Member  States  databases 
(same  databases/costs  as  in  4 
A)b), repetition) 

c) 
Information  management: 
Simple  website  with  links  to 
documents 
directed 
uploaded on the EU site or links 
to  Member  States  websites  with 
the information/documents 

either 

d)  fully  integrated  central  EU 
database  

5: 

land-use 

Policy 
planning 

issue 

a) do nothing 

No additional costs  No improvements in 

Member States 
provisions 

Slight increase 

Better access to 
information  

Increase. Significant 
Improvement in 
information available 

As above. Plus 
more 
harmonisation, less 
fragmentation, 
streamlining and 
simplification  

As above 

As above 

One-off costs 
around 0.5 to 1 
million EUR 

50,000-100,000 per 
year in 
maintenance plus 
some Member 
State costs  

50,000-100,000 per 
year in 
maintenance plus 
some Member 
State costs 

One-off costs of 1 
million to set up 
link/upload 
documents 

Substantial costs to 
adapt all existing 
systems to one 
database format 

No costs 

No impacts 

EN 

105 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
Option component 

b) minor clarifications 

c) extend requirements 

6A:  Closer 
issue 
Policy 
coordination, 
integration  of 
information  and  procedures, 
etc 

Economic  
impacts, inc 
change of scope 
for policy issue 122 

No costs or 
potential savings  

Potentially very 
costly with one-off 
costs of several 
hundred million or 
billions EUR  

Cost savings of 
approx 0.5 million 
EUR per year 
(coordination of 
inspections). No 
additional costs 

Other impacts 
including 
simplification, 
administrative 
efforts, etc 

Protection level23  

Limited impacts 

Significant  increase 

No impact or slight 
increase in protection 
level 

Simplification. 
Greater efficiency. 
More harmonised 
implementation 

Policy 
improvements/clarifications 

issue 

6B: 

other 

Safety performance indicators 

a) mandatory requirement to use SPI 

b)Include reference to the use of SPI 
for internal safety   

c) Guidance  

Safety management 
requirements for LT sites 

a) Clarify existing provisions 

b) 
Increase 
requirements 
include SMS 

safety  management 
to 
for 

lower 

tier 

Potential significant 
costs 

Potential increase 

No additional costs 

Potential increase 

No additional costs 

Potential increase 

No significant 
change/potential 
small savings 

No change 

Potential significant 
costs 

Some increase 

c)  Require  mini-safety  report  and 
internal emergency plan for LT sites 

 25 million EUR one-
off costs 

Increase 

Many Member States 
already have such 
requirements. two-
tier approach 

 As above.  Further 
undermines two-tier 
approach 

d) Require SMS, mini- safety report 
and IEP 

(such 

clarifications 

Other 
as 
underground  gas  storage,  domino 
aspects, 
environmental 
effects, 
deadlines  for  emergency  plans,  and 
deadlines 
for 
accident reporting 

thresholds 

and 

More than 25 million 
EUR one-off costs + 
app. 1 million EUR 
annually 

Limited additional 
costs (1.5 million 
EUR annual cots for 
underground gas 
storage)  

Increase 

EN 

106 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX XIII 

GLOSSARY: 

Acute Toxicity Estimates 

Competent Authority 

Committee  of  competent  authorities  for  the  implementation  of  the  Seveso  II 
Directive 

Carbon Capture and Storage 

Classification,  labelling  and  packaging,  stands  for  Regulation  (EC)  No. 
1272/2008  on  classification,  labelling  and  packaging  of  substances  and 
mixtures 

ATE 

CA  

CCA 

CCS 

CLP 

CLWP 

Commission Legislative and Work Programme  

CO2 

Carbon Dioxide 

COM   

European Commission 

COWI  

COWI A/S Consultancy, DK-2800 Kongens Lyngby, www.cowi.com  

DPD 

EEP 

EIA  

GHS 

H2 

HSE  

IEP 

IPPC 

Dangerous Preparations Directive (DPD)  

External Emergency Plan 

Environmental Impact Assessment 

UN  Globally  Harmonized  System  of  Classification  and  Labelling  of 
Chemicals 

Hydrogen 

Health and Safety Executive (UK authority) 

Internal Emergency Plan 

Integrated Pollution Prevention and Control Directive 

INSPIRE 

Infrastructure  for  Spatial  Information  in  the  European  Community  (Directive 
2007/2/EC) 

ISSG    

Inter-Service Steering Group  

KPI 

LPG  

LT 

Key Performance Indicator (CostKPI) 

Liquefied Petroleum Gas 

Lower Tier Seveso establishment (Article 6 and 7) 

EN 

107 

   EN 

 
 
 
 
 
 
 
 
 
 
MARS  

Major Accident Retrieval System (Seveso accidents database, 2009: eMARS) 

MAPP  

Major Accident Prevention Policy 

MJV 

MS  

REACH 

Mutual Joint Visits (Seveso Inspection Programme) 

Member State 

Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals 
(Regulation 1907/2006) 

SEA 

Strategic Environmental Assessment’ 

SEVESO 

Directive 96/82/EC (Seveso II Directive) 

SEIS    

Shared Environmental Information System  

SMEs   

Small and Medium sized Enterprises 

SMS 

SPI 

Safety Management System 

Safety Performance Indicator 

SPIRS  

Seveso Plants Information and Retrieval System (Seveso sites database)  

SR  

Safety Report (Article 9 Seveso obligation) 

TWG    

Technical Working Group, here TWG "Seveso and GHS" 

UT 

Upper Tier Seveso establishment (Article 9) 

EN 

108 

   EN