COMMISSION STAFF WORKING DOCUMENT SUMMARY OF THE 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) 1590 final
Date: 2010-12-21
Institutions: European Commission
Subjects: accident prevention, dangerous substance, environmental risk prevention, industrial hazard, public health

EN 

EN 

   EN 

 
EUROPEAN COMMISSION  

Brussels, 21.12.2010 
SEC(2010) 1591 final 

COMMISSION STAFF WORKING DOCUMENT 

SUMMARY OF THE 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) 1590 final 

EN 

   EN 

 
 
  
 
 
 
 
 
TABLE OF CONTENTS 

1. 

2. 

3. 

4. 

5. 

Problem definition........................................................................................................ 2 

Analysis of subsidiarity................................................................................................ 3 

Objectives..................................................................................................................... 3 

Policy options, including analysis of impacts and comparison.................................... 4 

Monitoring and evaluation ......................................................................................... 10 

EN 

2 

   EN 

1. 

PROBLEM DEFINITION 

Problem addressed by the Seveso Directive 

Chemical accidents often have serious, even devastating, consequences. Some well-
known  major  accidents  like  Seveso,  Bhopal,  Schweizerhalle,  Enschede,  Toulouse 
and  Buncefield  have  taken  many  lives  and  cost  up  to  billions  of  euro.  The  Seveso 
legislation addresses accident prevention and preparedness and lessons learned from 
such accidents. The current Seveso II Directive 96/82/EC was adopted in 1996 and 
amended by Directive 2003/105/EC. 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 human health 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 frequency of major accidents has fallen by some 20% between 2000 and 2008. 
This suggests that the Directive is meeting its objectives. Furthermore, the fact that 
the Seveso approach has been copied worldwide attests to its success. 

Problem addressed by this Impact Assessment Report 

The Directive has to be amended due to changes in the EU system of classification of 
dangerous substances to which Annex I refers. That system has been replaced by the 
Regulation  (EC)  No.  1272/2008  on  classification,  labelling  and  packaging  of 
substances  and  mixtures  (CLP),  which  becomes  definitive  on  1  June  2015.  The 
alignment to the CLP Regulation raises three main issues. The key issue is how the 
alignment of Annex I to the CLP Regulation is implemented (policy issue 1). Related 
to that issue are possible other technical amendments to Annex I defining the scope 
(policy issue 2) and the procedures for adapting Annex I in the future (policy issue 3) 
to specific cases requiring more flexible solutions than are offered by the reference to 
the CLP Regulation. 

Given the need to make this amendment, it was decided to undertake a wider review 
of the Directive since it has remained essentially unchanged since its adoption. While 
the  review  has  confirmed  that  the  Directive  has  been  instrumental  in  reducing  the 
likelihood and consequences of chemical accidents and the existing provisions are fit 
for purpose, a number of areas were identified where limited amendments would be 
appropriate  to  clarify  and  update  certain  provisions.  The  most  significant  of  these 
relate  to  information  to  the  public  and  information  managements  systems  (policy 
issue  4)  and  land-use  planning  (policy  issue  5),  where  some  opportunities  for 
improvements  may  exist.  The  other  issue  relates  to  relatively  minor  changes  to  a 
number  of  detailed  provisions  which  could  usefully  be  clarified  or  updated  (policy 
issue 6). 

2. 

ANALYSIS OF SUBSIDIARITY 

Action  at  EU  level  is  needed  to  amend  the  Directive,  to  ensure  that  existing  high 
levels  of  protection  of  human  heath  and  the  environment  throughout  the  EU  are 
maintained, and to promote greater harmonisation in implementation. This will help 
to avoid significantly different levels of protection in the Member States and possible 
distortions  to  competition  that  could  result.  The  subsidiarity  principle  is  respected 

EN 

3 

   EN 

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.  

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. 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. The Directive should also be clear, coherent and easy to understand to help 
increase consistency of implementation. 

The  main  specific  objective  is  to  align  Annex  I  to  the  CLP  while  maintaining 
existing levels of protection. The other specific aims are to clarify certain provisions 
to improve implementation and enforceability. Other provisions should be updated to 
take  account  of  technological  and  regulatory  developments  since  the  current 
Directive's adoption. In addition, where possible requirements should be streamlined 
or  simplified  to  reduce  the  administrative  burden  for  operators  and  competent 
authorities without compromising safety. 

4.  POLICY OPTIONS, INCLUDING ANALYSIS OF IMPACTS AND COMPARISON 

Policy issue 1: alignment of Annex I to the CLP Regulation 

This is the core of the impact assessment. 

This  alignment  must  be  made  for  a  series  of  hazard  classification  categories  of 
dangerous substances, but is only problematic for toxicity. This is due to the fact that 
the CLP Regulation introduces three new toxicity categories that do not completely 
correspond to the previous two categories that they replace, with different thresholds 
or  cut-off  values.  Moreover  the  new  toxicity  categories  are  divided  into  three 
exposure  routes  (oral,  dermal,  inhalation).  Therefore  the  options  considered  vary 
with respect to which categories and exposure routes are taken into account. 

Although  there  is  some  uncertainty  as  regards  the  impacts  over  time,  the  overall 
assessment is that the impact of all of the options, as well as the difference of impacts 
between them, is limited. 

The impact would be to slightly modify the scope of the Directive. Depending on the 
option, up to 405 of the establishments currently covered could fall out of the scope 
(-4.2%)  and  up  to  342  new  establishments  could  be  caught  (+3.4%).  This  would 
cause impacts of a comparable magnitude on administrative compliance costs and the 
protection  level.  The  overall  cost  impact  is  low  compared  with  the  overall 
administrative costs of the Directive. There would be one-off costs for adjustment to 
the  CLP  (which  all  operators  would  have  to  make  whatever  option  is  chosen) 
estimated as 1.7 million EUR. There would also be option-related costs (or savings) 
for industry ranging from a cost increase of 4.9 million EUR per year to cost savings 
of 1.1 million EUR depending on the option chosen. The cost impact for authorities 
is  estimated  at  about  10%  of  the  costs/savings  to  industry.  This  compares  with 

EN 

4 

   EN 

estimated total administrative costs of the Directive for industry of about 52 million 
EUR per year for industry and authorities together of at least 100 million EUR. Other 
aspects  evaluated  qualitatively,  which  relate  to  practical  implementation  and 
administrative  complexity/effort  and  will  run  beyond  the  initial  alignment  exercise, 
also need to be taken into account. 

In  the  light  of  this  assessment  one  option  is  preferable  as,  in  addition  to  having  a 
limited  impact  on  scope,  shared  with  other  options,  it  maintains  a  high  level  of 
protection taking into account the most likely exposure routes in the event of a major 
accident.. 

Policy issue 2: other technical amendments to Annex I 

The  options  relate  to  whether  specific  product  categories  or  substances  are 
appropriately  covered  by  the  Directive,  including  certain  products/substances 
affected by the CLP. The options range from maintaining the status quo to defining 
specific higher thresholds for the substances concerned or derogations for packaged 
products. 

The different options are likely to have marginal overall impact.  Options involving 
increased thresholds, etc could bring limited costs savings for the affected industries, 
but could reduce the protection levels. 
The preferred options are those maintaining or increasing the level of protection. 

Policy issue 3: future adaptation of Annex I 

As  mentioned  under  policy  issue  1,  there  are  uncertainties  about  the  longer  term 
impacts of the initial alignment of Annex I, and in particular its automatic adaptation 
to  future  changes  in  classifications  of  substances  and  mixtures  in  the  future.  This 
suggests  a  need  to  be  able  to  adapt  Annex  I  as  necessary  via  delegated  acts.  The 
option  is  a  package  of  tools  including  EU-wide  substance  derogations  and 
establishment-specific  derogations  at  Member  State  level,  with  as  a  counterpart  a 
safeguard clause enabling the inclusion of non-captured hazards.  

Such  a  package,  together  with  the  use  of  delegated  acts  to  amend  Annex  I,  would 
provide  the  necessary  flexibility  to  deal  with  situations  arising  from  the  CLP 
alignment where substances are included/excluded under the Directive that do/do not 
present  a  major-accident  hazard.  This  would  have  a  positive  effect  on  protection 
levels and a net positive effect on costs. 

The options assessed under this policy issue are all complementary and are preferred 
options. 

Policy issue 4: information to the public and information management systems 

The aim is to improve the information provided to the public, including that reported 
to the competent authorities. This would be in the interest of transparency and ensure 
that the public is aware of the dangers and appropriate action to take in the event of 
an accident. The different options represent a scaled approach, starting from business 
as usual to including much more detailed information. 

It  is  also  important  that  the  information  is  collected,  managed  and  shared  in  an 
efficient  and  streamlined  way,  thereby  facilitating  reporting  and  monitoring  of 
implementation.  The  options  for  this  range  from  the  establishment  of  databases  at 
Member State level to a fully integrated central EU database. The assessment shows 

EN 

5 

   EN 

that the more information has to be made available, the greater the costs. However 
the more the level of the information is improved, the greater the potential benefits in 
terms of protection levels. Similarly, the more information management is improved, 
the greater would be the costs and benefits. 

On the basis of cost benefit considerations, the preferred options are those improving 
the availability of relevant information level whilst entailing only moderate costs.  

Policy issue 5: land-use planning 

The  aim  is  to  consider  how  major-accident  hazards  could  be  better  considered  in 
land-use  planning.  The  Directive  includes  requirements  that  Member  States  should 
control the siting of new establishments, modifications to existing establishments and 
new  developments  in  their  vicinity  through  appropriate  safety  distances  or,  in  the 
case of existing establishments, additional technical measures. Further clarifications 
and improvements may warrant consideration. Options are to maintain but clarify the 
existing provisions, emphasising environmental protection and making references to 
possible integration of procedures with those under similar legislation; or to extend 
the provisions in relation to new establishments to existing sites. 

The  latter  option  could  have  significant  cost  implications,  but  would  also  lead  to 
significant increases in protection levels. However there is too little experience with 
practical implementation of such an approach to support a concrete proposal at this 
stage. 

Therefore the first option is preferred. This is not expected to have any major impacts 
on costs, but may improve protection levels. 

Policy issue 6: other clarifications 

The  aim  is  closer  coordination  between  different  authorities,  better  integration  of 
information  and  procedures  to  facilitate  more  consistent  implementation  and 
streamlining and simplification to reduce administrative burdens. The aim is also to 
clarify  a  number  of  provisions  to  improve  enforceability  and  the  effectiveness  of 
implementation. A raft of possible option components is assessed. Those that would 
contribute  towards  closer  coordination,  etc  are  likely  to  have  a  positive  overall 
impact  in  terms  of  implementation,  simplification  and  reduction  of  administrative 
burdens (although it is difficult to quantify this), with possibly some improvements 
in  existing  levels  of  protection.  Likewise,  the  elements  aimed  at  clarifying  and 
improving certain provisions will lead to clearer and better regulation, and improve 
protection levels without imposing significant additional costs. 

The  sub-options  retained  in  this  package  include  (1)  the  sub-options  potentially 
providing savings with no reduction of protection, and (2) the sub-options providing 
an increase in protection at the lowest cost. 

General observations on the impacts 

Overall,  the  potential  changes  considered  represent  a  moderate  adaptation  of  the 
Directive and would not significantly affect the level of protection or the Directive's 
costs.  The  costs  of  the  various  different  options  are  low  compared  with  the 
Directive's total costs. 

EN 

6 

   EN 

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  Directive's  tiered  approach,  with  only  basic 
requirements  for  lower-tier  establishments,  which  take  into  account  SMEs' 
capacities.  

The available information suggests that the proportion of the establishments that are 
SMEs  that  would  newly  fall  under  the  scope  of  the  Directive  as  a  result  of  the 
alignment  to  CLP  would  not  be  different  from  the  proportion  of  establishments 
currently  covered  by  the  Directive  that  are  SMEs  –  however,  uncertainties  remain 
due  to  the  limited  information  available  for  mixtures.  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.  However  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, as SMEs are by their nature more sensitive to an increase in costs than larger 
businesses. However, the options considered under policy issue 3 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. 

Sections 5 and 6 of the main report compare all the main options within the different 
policy  issues,  including  their  costs/impacts  and  benefits.  The  following  table 
summarises the preferred options.  

Option component 

Protection level2  

Economic  
impacts, inc change 
of  scope  for  policy 
issue 11 

impacts 

Other 
including 
simplification, 
administrative 
efforts, etc 

Policy  Issue  1:  Alignment  of 
Annex I 

E* 

Costs  up 
to  2.4 
million  EUR  per 
year 

Small 
(exclusion 
exposure 
Acute 
category) 

decrease 
oral 
of 
for 
route 
3 
Toxic 

Slightly  higher  due 
differentiated 
to 
exposure routes 

Policy  Issue  2:  other  technical 
amendments to Annex I 

Hydrogen: a) do nothing 

Neutral 

Unchanged 

Heavy  fuel  oil:  b)  avoid  the  Neutral 

Unchanged 

1 

2 

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.  
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 

7 

   EN 

 
 
 
 
 
 
 
 
                                                 
Option component 

Protection level2  

Economic  
impacts, inc change 
of  scope  for  policy 
issue 11 

impacts 

Other 
including 
simplification, 
administrative 
efforts, etc 

possible  effect  by  listing  as 
named  substance  with  other 
petroleum products 

a) 
Aerosols: 
approximation 
150/500) 

the 
proposal 

CLP 
of 

+ App. 0. 5 million 
EUR per year 

Unchanged/ 
slightly increased 

Sodium hypochlorite: a) accept 
CLP  re-classification  effect  for 
mixtures 

+  Up  to  3.5  to  4 
million  EUR  per 
year 

Increased 

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

savings 
industry  and 

Potential 
for 
CAs 

low 

No  or 
(condition 
derogation) 

impact 
for 

Potential 
market distortion  

risk 

of 

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

Potential 
significant  savings 
for 
industry  and 
CAs 

No  impact  (condition 
for derogation) 

Allows  flexibility  in 
light of CLP  

3 e) Introduce Safeguard clause  Potential 
in scope  

increase 

Potential increase 

Allows  flexibility  in 
light of CLP  

Policy  Issue  4A  –  Type  of 
information to the public3 

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

from 

One-off 
costs 
around  2-4  million 
EUR 

Increase. 
Improvement 
in 
information available  

Annual  costs  up 
0.5 million EUR 

access 

Better 
to 
information. 
Less 
in 
consequences 
event  of  accident 
lessons-
Aids 
learning 
and 
exchange  of  best 
practices, monitoring 
of 
actual 
implementation  etc. 
Improved, 
transparency.  

3 

Confidentiality issues will be considered 

EN 

8 

   EN 

 
 
 
 
 
 
                                                 
Option component 

Protection level2  

Economic  
impacts, inc change 
of  scope  for  policy 
issue 11 

impacts 

Other 
including 
simplification, 
administrative 
efforts, etc 

Policy  issue  4B:  management 
of information  

either 

c) Simple website with links to 
directed 
documents 
uploaded  on  the  EU  site  or 
States 
links 
to  Member 
websites 
the 
information/documents 

with 

Increase.  Significant 
in 
Improvement 
information available 

As above. Plus more 
less 
harmonisation, 
fragmentation, 
streamlining 
simplification  

and 

50,000-100,000 
EUR  per  year  in 
maintenance  plus 
some 
Member 
State costs 

One-off  costs  of  1 
million  EUR  to  set 
up 
link/upload 
documents 

Policy 
planning 

issue 

5: 

land-use 

b) minor clarifications 

issue 

Policy 
6A:  Closer 
integration  of 
coordination, 
information and procedures, etc 

costs 

No 
potential savings  

or 

Limited impacts 

Cost 
savings  of 
approx  0.5  million 
year 
EUR 
per 
(coordination 
of 
inspections).  No 
additional costs 

No  impact  or  slight 
increase  in  protection 
level 

Simplification. 
Greater 
More 
implementation 

efficiency. 
harmonised 

Policy 
improvements/clarifications 

issue 

6B: 

other 

Safety performance indicators 

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

No 
additional costs 

significant 

Potential increase 

c) Guidance  

No additional costs  Potential increase 

Safety 
requirements for LT sites 

management 

a) Clarify existing provisions 

gas 

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

deadlines 

No change 

Increase 

significant 

No 
change/potential 
small savings 

Limited  additional 
costs  (1.5  million 
EUR  annual  costs 
for 
underground 
gas storage)  

EN 

9 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5. 

MONITORING AND EVALUATION 

Monitoring and evaluation of the Directive at EU level will continue to be based on 
specific indicators. The main core indicators include the number of major accidents 
reported, the number of establishments covered by the Directive and the provision of 
plans  and  reports.  Existing  monitoring  and  reporting  tools  will  be  simplified  and 
streamlined  as  outlined  under  policy  issue  4.  Monitoring  the  impact  of  the  CLP 
alignment  of  Annex  I  in  practice  and  the  effectiveness  of  envisaged  correction 
mechanisms, the indicators will be based on the number of lower-tier and upper-tier 
establishments,  and  information  about  their  activities  and  the  main  dangerous 
substances  concerned,  plus  the  number  of  derogations  granted  and  the  reasons  for 
these. 

EN 

10 

   EN