EN    EN 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 PARLIA MENT AND OF THE COUNCIL on the 
control of major-accident hazard s involving dangerous substances 
   
COM(2010) 781 final 
SEC(2010) 1590 final 
EN 2   EN TABLE OF CONTENTS 
1. Problem definition........................................................................................................ 2 
2. Analysis of subsidiarity................................................................................................ 3 3. Objectives.................................................................................................................. ... 3 
4. Policy options, including analys is of impacts and comparison.................................... 4 
5. Monitoring and evaluation ......................................................................................... 10 
EN 3   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 co st up to billions of euro. The Seveso 
legislation addresses accide nt prevention and preparedness and lessons learned from 
such accidents. The current Seveso II Di rective 96/82/EC was adopted in 1996 and 
amended by Directive 2003/105/EC. Its main objective is to prev ent major accidents 
involving large quantities of dangerous substa nces (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 cha nges in the EU system of classification of 
dangerous substances to which Annex I refe rs. That system has been replaced by the 
Regulation (EC) No. 1272/2008 on classifi cation, labelling and packaging of 
substances and mixtures (CLP), whic h 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 adap ting Annex I in the futu re (policy issue 3) 
to specific cases requiring more flexible so lutions 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 esse ntially unchanged since its adoption. While 
the review has confirmed that the Directiv e has been instrument al in reducing the 
likelihood and consequences of chemical acci dents and the existing provisions are fit 
for purpose, a number of areas were iden tified where limited amendments would be 
appropriate to clarify and update certain provisions. Th e 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 provisi ons which could usefully be clarified or updated (policy 
issue 6). 
2. A
NALYSIS OF SUBSIDIARITY  
Action at EU level is needed to amend the Directive, to ensure that existing high 
levels of protection of human heath a nd the environment throughout the EU are 
maintained, and to promote greater harmoni sation 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 4   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 im proving existing levels  of protection. In 
line with the Commission's strategic objective s and better regulati on principles, this 
should be achieved by improving the regu latory provisions to make them more 
effective and efficient, and where possi ble reducing unnecessa ry administrative 
burdens. The Directive should al so 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 specif ic aims are to clarif y certain provisions 
to improve implementation and enforceability. Other provisions should be updated to take account of technological and regulat ory developments since the current 
Directive's adoption. In addition, where pos sible requirements should be streamlined 
or simplified to reduce the administrative burden for operators and competent authorities without compromising safety. 
4. P
OLICY 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 seri es of hazard classification categories of 
dangerous substances, but is only problematic fo r toxicity. This is due to the fact that 
the CLP Regulation introduces three new toxi city categories that do not completely 
correspond to the previous two categories that  they replace, with different thresholds 
or cut-off values. Moreover the new toxi city categories are divided into three 
exposure routes (oral, dermal, inhalation) . Therefore the options considered vary 
with respect to which categories and e xposure routes are taken into account. 
Although there is some uncertainty as re gards 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 th e scope of the Directive. Depending on the 
option, up to 405 of the establishments curr ently 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 imp act 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 al so 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 5   EN estimated total administrative costs of th e Directive for industry of about 52 million 
EUR per year for industry and authorities t ogether of at least 100 million EUR. Other 
aspects evaluated qualitatively, which re late 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 ot her options, it mainta ins a high level of 
protection taking into ac count the most likely exposure r outes in the event of a major 
accident.. 
Policy issue 2: other techni cal 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 stat us quo to defining 
specific higher thresholds for the substan ces 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 maintaini ng 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 s ubstances and mixtures in the future. This 
suggests a need to be able to adapt Anne x I as necessary via delegated acts. The 
option is a package of tools includi ng EU-wide substance derogations and 
establishment-specific derogations at Memb er State level, with  as a counterpart a 
safeguard clause enabling the in clusion 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/e xcluded under the Dir ective that do/do not 
present a major-accident hazard. This woul d 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 pub lic and information management systems 
The aim is to improve the information provi ded to the public, incl uding that reported 
to the competent authorities. This would be in the interest of transparency and ensure 
that the public is aware of th e dangers and appropriate actio n 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 informati on 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 6   EN that the more information has to be made available, the greater the costs. However 
the more the level of the information is im proved, the greater the potential benefits in 
terms of protection levels. Similarly, the more information management is improved, 
the greater would be th e costs and benefits. 
On the basis of cost benefit considerati ons, the preferred opti ons are those improving 
the availability of relevant information le vel 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 re quirements that Member States should 
control the siting of new establishments, m odifications to existing establishments and 
new developments in their vi cinity through appropriate sa fety distances or, in the 
case of existing establishments, additional te chnical measures. Further clarifications 
and improvements may warrant consideration. Options are to maintain but clarify the 
existing provisions, emphasising environmen tal protection and ma king references to 
possible integration of procedures with thos e 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 protec tion 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 pr eferred. 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 coordinati on between different authoritie s, better integration of 
information and procedures to facilita te more consistent implementation and 
streamlining and simplification to reduce admi nistrative 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, et c are likely to have a positive overall 
impact in terms of implementation, simp lification and reduction of administrative 
burdens (although it is difficult to quantify this), with possibl y some improvements 
in existing levels of protection. Likewise , the elements aimed at clarifying and 
improving certain provisions will lead to clearer and better re gulation, and improve 
protection levels without imposing significant additional costs. 
The sub-options retained in this packag e include (1) the s ub-options potentially 
providing savings with no reduction of protection, and (2 ) the sub-options providing 
an increase in protecti on at the lowest cost. 
General observations on the impacts 
Overall, the potential changes considered represent a moderate adaptation of the 
Directive and would not signifi cantly affect the level of protection or the Directive's 
costs. The costs of the various differe nt options are low compared with the 
Directive's total costs. 
EN 7   EN The Seveso approach addressing major h azards of large quantities of chemicals, 
which are predominantly present in larger companies, limits the possible impacts on SMEs. This is reflected in the Direct ive'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 w ould 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 SM Es. 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 se nsitive 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/im pacts and benefits. The following table 
summarises the preferred options.  
Option component Economic  
impacts, inc change 
of scope for policy issue 1
1 Protection level2  Other impacts 
including 
simplification, administrative 
efforts, etc 
Policy Issue 1: Alignment of 
Annex I    
E* 
Costs up to 2.4 
million EUR per 
year Small decrease 
(exclusion of oral 
exposure route for Acute Toxic 3 
category) Slightly higher due 
to differentiated 
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 Economic impacts are administra tive costs. Non-administrative comp liance 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.  
2 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 8   EN Option component Economic  
impacts, inc change 
of scope for policy 
issue 11 Protection level2  Other impacts 
including 
simplification, 
administrative efforts, etc 
possible effect by listing as 
named substance with other 
petroleum products 
Aerosols: a) the CLP approximation proposal of 
150/500) + 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  Potential savings 
for industry and CAs No or low impact 
(condition for derogation) Potential risk of 
market distortion  
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 increase 
in scope  Potential increase Allows flexibility in 
light of CLP  
Policy Issue 4A – Type of information to the public
3    
c) Additional information on 
basic data for all sites plus 
accident scenarios and key information from external 
emergency plan for upper tier 
(revised Annex V) on line One-off costs 
around 2-4 million 
EUR 
Annual costs up 
0.5 million EUR Increase. 
Improvement in 
information available  
 Better access to 
information. Less 
consequences in event of accident 
Aids lessons-
learning and 
exchange of best 
practices, monitoring of actual 
implementation etc. 
Improved, transparency.  
                                                 
3 Confidentiality issues will be considered 
EN 9   EN Option component Economic  
impacts, inc change 
of scope for policy 
issue 11 Protection level2  Other impacts 
including 
simplification, 
administrative efforts, etc 
Policy issue 4B: management 
of information     
c) Simple website with links to 
documents either directed uploaded on the EU site or 
links to Member States 
websites with the 
information/documents 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 Increase. Significant 
Improvement in information available 
 As above. Plus more 
harmonisation, less fragmentation, 
streamlining and 
simplification  
Policy issue 5: land-use planning    
b) minor clarifications No costs or 
potential savings  Limited impacts  
Policy issue 6A: Closer 
coordination, integration of 
information and procedures, etc Cost savings of 
approx 0.5 million 
EUR per year (coordination of 
inspections). No 
additional costs No impact or slight 
increase in protection 
level Simplification. 
Greater efficiency. 
More harmonised implementation 
Policy issue 6B: other improvements/clarifications    
Safety performance indicators    
b)Include reference to the use 
of SPI for internal safety No significant 
additional costs Potential increase  
c) Guidance  No additional costs Potential increase  
Safety management 
requirements for LT sites    
a) Clarify existing provisions No significant 
change/potential 
small savings No change  
Other clarifications (such as 
underground gas storage, 
domino effects, environmental 
aspects, deadlines for emergency plans, and deadlines 
and thresholds for accident 
reporting Limited additional 
costs (1.5 million 
EUR annual costs 
for underground gas storage)  Increase  

EN 10   EN 5. MONITORING AND EVALUATION  
Monitoring and evaluation of th e Directive at EU level will continue to be based on 
specific indicators. The main core indicator s include the number of major accidents 
reported, the number of establishments cove red by the Directive and the provision of 
plans and reports. Existing monitoring and reporting tools will be simplified and streamlined as outlined unde r policy issue 4. Monitori ng the impact of the CLP 
alignment of Annex I in practice and th e effectiveness of envisaged correction 
mechanisms, the indicators will be based on the number of lower-tier and upper-tier 
establishments, and information about th eir activities and the main dangerous 
substances concerned, plus the number of derogations granted and the reasons for 
these.