Commission staff working document - Accompanying document to the proposal for a Council directive (Euratom) setting up a Community framework for Nuclear Safety - Summary of the impact assessment {COM(2008) 790 final} {SEC(2008) 2892}
Date: 2008-11-26
Institutions: European Commission
Subjects: EU aid, EU financing, cooperation policy, nuclear safety, technical cooperation

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 26.11.2008 
SEC(2008) 2893 

COMMISSION STAFF WORKING DOCUMENT 

Accompanying document to the 

Proposal for a 

COUNCIL DIRECTIVE (Euratom) 

setting up a Community framework for Nuclear Safety 

SUMMARY OF THE IMPACT ASSESSMENT 

{COM(2008) 790 final} 
{SEC(2008) 2892} 

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1. CONSULTATION AND EXPERTISE 

The  Impact  Assessment  relates  to  the  agenda  planning  item  2008/TREN/003  -  Revised 
legislative proposal on nuclear safety. It accompanies the draft revised Directive setting up a 
Community framework for Nuclear Safety which aims to re-start the process of establishing a 
common  EU  framework  on  nuclear  safety,  by  replacing  the  proposed  Directive  setting  out 
basic obligations and general principles on the safety of nuclear installations1 presented by the 
Commission in 2003.  

This new proposal is the result of an extensive and continuous consultation process, initiated 
in 2004 during the Irish Presidency of the Council. Subsequently, the Council Working Party 
on Nuclear Safety (WPNS), the High Level Group on Nuclear Safety and Waste Management 
(HLG) and the European Nuclear Energy Forum continued work on this issue. 

The  consultation  process  that  started  in  2004  has  resulted  in  a  thorough  revision  of  the 
approach taken in the 2004 proposal for a safety Directive, which at the time faced a blocking 
minority of Member States. The main arguments were a too detailed prescription of binding 
legislation,  as  well  as  doubts  whether  the  proposal  would  fully  respect  the  subsidiarity 
principle.  

The  revised  legislative  proposal  on  nuclear  safety  builds  on:  a)  the  technical  work  of  the 
Western European Nuclear Regulators Association (WENRA) completed in 2006 for existing 
nuclear  installations,  with  the  participation  of  all  European  nuclear  safety  regulators;  b)  the 
principle that only strong and independent regulators can ensure the continued safe operation 
of nuclear power plants in the EU; c) enshrining in the European legislation the principles of 
the main international instruments available, namely the Convention on Nuclear Safety2 and 
the safety work carried out by the International Atomic Energy Agency (IAEA), particularly 
its safety fundamental principles3. In addition, the technical background supporting the basic 
principles  proposed  in  the  draft  revised  Directive  setting  up  a  Community  framework  for 
Nuclear  Safety  was  provided  by  the  outcome  of  the  activity  of  the  different  expert  groups 
dealing with nuclear safety matters.  

The European Parliament has constantly supported the setting up of European nuclear safety 
legislation  establishing  reference  levels,  as  illustrated  over  the  years  in  its  Reports4. 
Additionally, as reflected in the Conclusions of the 2nd European Nuclear Energy Forum, the 
industry is now a firm supporter of EU nuclear safety legislation.  

Finally,  for  the  purpose  of  finalising  the  Impact  Assessment,  a  Steering  Group  was  set  up, 
involving representatives of all the interested services of the Commission. 

The draft Impact Assessment has been submitted to the evaluation of the Impact Assessment 
Board, which has issued its initial opinion on 9 September 2008, followed by a final opinion 
on  14  October  2008  on  a  resubmitted  revised  document.  The  final  comments  of  the  Impact 
Assessment Board have been fully taken into account. 

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Initial  2003  Commission  proposal  (reference  doc.  COM(2003)  32  final)  and  revised  2004  version 
(reference doc. COM (2004)526 final) 
IAEA INFCIRC 449 of 5 July 1994 
IAEA  Safety  Fundamentals:  Fundamental  safety  principles,  IAEA  Safety  Standard  Series  No.  SF-1 
(2006) 
The latest were the Maldeikis report on the occasion of 50 years of the Euratom Treaty (reference doc. 
A6-0129/2007) and the Reul report on conventional energies (reference doc. A6-0348/2007). 

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2. PROBLEM DEFINITION 

The  renewed  interest  in  nuclear  power  expressed  by  a  number  of  Member  States,  with  the 
perspective  of  numerous  life  extensions  and  new  build,  makes  the  timing  of  this  revised 
proposal particularly appropriate. It is evident that the effects of radiological incidents do not 
stop at borders, with potential consequences both for the health of workers, citizens at large, 
but  also  wide  ranging  economic  implications  for  the  energy  generating  industry.  As  the 
protection  of  the  EU  public  is  one  of  the  main  political  objectives  of  the  EU,  a  legal 
framework  aiming  to  achieve,  maintain  and  continuously  improve  nuclear  safety  and  its 
regulation  in  the  Community,  as  well  as  enhance  the  role  of  the  Member  States'  regulatory 
bodies would create an additional level of guarantee for the public in the EU.  

Public acceptance is a prerequisite for the further development of nuclear energy and so far 
the  Community  has  been  consistently  active  in  promoting  nuclear  safety,  as  yet  there  is  no 
Community legal framework establishing common safety standards for the new and existing 
nuclear installations in the EU. However, the European citizens’ concerns about the safety of 
nuclear  installations  must  be  properly  addressed  by  the  Community.  One  of  the  main 
conclusions of the 2007 nuclear safety-related survey5 was that even if Europeans on average 
have a fair level of knowledge of nuclear issues, in particular whether or not there are nuclear 
power  plants  (NPPs)  in  their  countries,  they  feel  unfamiliar  with  the  issue  of  nuclear  safety 
(ranging from 56% to 90%). 

3. EU RIGHT TO ACT 

The  Community's  competence  to  set  up  basic  safety  standards  at  EU  level  is  explicitly 
regulated  in  the  Euratom  Treaty.  According  to  Art.  2,  letter  b)  of  the  Treaty,  "In  order  to 
perform  its  task,  the  Community  shall,  as  provided  in  this  Treaty:…establish  uniform  safety 
standards to protect the health of workers and of the general public and ensure that they are 
applied." Title Two, Chapter 3 "Health and Safety", sets up a number of detailed provisions 
intended to establish, give effect and apply the basic standards mentioned in Article 2(b) of 
the  Euratom  Treaty.  Chapter  3  of  the  Euratom  Treaty  has  been  used  mainly  for  radiation 
protection purposes until the recognition by the European Court of Justice of the intrinsic link 
between  radiation  protection  and  nuclear  safety  and  of  the  Community  competence  in  the 
field  of  nuclear  safety  (in  its  Ruling  in  Case  C-29/996,  the  Court  stated  that  “it  is  not 
appropriate,  in  order  to  define  the  Community’s  competencies,  to  draw  an  artificial 
distinction between the protection of the health of the general public and the safety of sources 
of ionising radiation.”). Therefore, this Ruling acknowledges the fact that the existing safety 
standards aiming to protect the health of workers and the general public against the dangers 
arising  from  ionizing  radiations  have  to  be  complemented  with  safety  standards  for  nuclear 
installations.  The  technical  competence  of  the  national  authorities  with  responsibility  for 
safety does not preclude the Community from legislating in this connection. 

4. SOURCES OF THE IMPACT ASSESSMENT  

The  Impact  Assessment  updates  the  2003  Impact  Assessment  related  to  the  initial  nuclear 
safety  proposal7,  having  as  technical  background  the  conclusions  and  recommendations 
identified  in  the  Final  Report  of  the  WPNS8,  approved  by  the  Council  Working  Party  on 

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Special Eurobarometer no 271 "Europeans and nuclear safety", Fieldwork Oct-Nov 2006, Publication 
Feb 2007 http://ec.europa.eu/public_opinion/archives/ebs/ebs_271_en.pdf 
Commission of the European Communities v Council of the European Union (Case C-29/99) 
Included in doc. COM(2003) 32 final 
doc. 15475/2/06 REV2 (http://register.consilium.europa.eu/pdf/en/06/st15/st15475-re02.en06.pdf) 

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Atomic Questions (WPAQ) on 13 December 2006 and complemented with the findings of the 
WPNS subgroups' reports9.  

In this context, a special emphasis should be put on the activity carried out in the framework 
of WENRA, an organisation comprising the Heads and senior staff members of the Nuclear 
Regulatory  Authorities  from  17  European  Countries10,  whose  members  have  defined  many 
common safety reference levels for power reactors with a view to align national requirements 
by the year 2010. 

Secondly, the Impact Assessment is based on the obligations and requirements of the IAEA 
Convention  on  Nuclear  Safety,  which  constitutes  an  internationally  recognised  platform  for 
nuclear  safety  development,  as  well  as  on  the  principles  of  the  IAEA  Safety  Fundamentals. 
The Convention does not contain detailed technical rules; however, it sets up a precise legal 
framework aiming to the continuous improvement of safety. Euratom and all the EU Member 
States are Contracting Parties to the Convention on Nuclear Safety. The IAEA fundamentals 
constitute  a  framework  of  practices  on  which  national  safety  requirements  are  based  and  to 
the improvement of which Member States have made considerable contributions. 

5. POLICY OPTIONS 

The Impact Assessment considers four policy options:  

–  Policy option 0 consists in keeping the current situation unchanged; 

–  Policy option 1 envisages the elaboration of Community legislation establishing common 

safety standards for existing nuclear installations;  

–  Policy  option  2  consists  in  the  elaboration  of  Community  legislation  that  sets  up  only  a 
common framework aiming at achieving and maintaining a high uniform level of nuclear 
safety throughout the Community by recalling widely recognised nuclear safety principles, 
the subsequent implementing measures will be prepared within the HLG; 

–  Policy  option  3  is  built  upon  a  set  of  internationally-recognised  nuclear  safety  principles 
(approach proposed by Policy option 2), supplemented with additional safety requirements 
for  new  nuclear  power  reactors,  which  Member  States  are  encouraged  to  develop  in  line 
with  the  principle  of  continuous  improvement  of  safety,  on  the  basis  of  the  safety  levels 
developed by WENRA and in close collaboration with the HLG11, comprising high-level 
representatives of the regulatory and safety authorities from all the EU Member States. 

6. COMPARING THE OPTIONS – PROPOSED EU ACTION 

The  assessment  of  the  options  showed  that  the  most  efficient  solution  for  setting  up  a 
Community  nuclear  safety  framework  is  the  one  envisaged  by  Policy  option  3.  Hence,  the 
basic approach of the current proposed revised Directive is that the Community sets up only a 
set  of  common  principles  in  the  field  of  nuclear  safety,  already  included  in  the  IAEA 
Convention on Nuclear Safety (enhancing the role of national regulators, prime responsibility 
of  the  licence  holder  for  safety  under  the  control  of  the  regulatory  body,  reinforcing  the 
independence of the regulatory body, ensuring a high level of transparency on issues related 

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2  ADD 

15475/2/06  REV 

1(http://register.consilium.europa.eu/pdf/en/06/st15/st15475-
doc. 
re02ad01.en06.pdf)  doc.  15475/2/06  REV  2  ADD  2 
(http://register.consilium.europa.eu/pdf/ 
en/06/st15/st15475-re02ad02.en06.pdf)  doc.  15475/2/06  REV  2  ADD  3  (http://register.consilium. 
europa.eu/pdf/en/06/st15/st15475-re02ad03.en06.pdf) 
Belgium, Bulgaria, Czech Republic, Finland, France, Germany, Hungary, Italy, Lithuania, Netherlands, 
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, and UK. 
established by the Commission Decision 2007/530/Euratom of 17 July 2007 (O.J. L 195 , 27/07/2007) 

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to the safety of nuclear installations, implementation of management systems, regular safety 
supervision,  availability  of  nuclear  safety  expertise,  priority  to  safety),  supplemented  with 
additional  safety  requirements  for  new  nuclear  power  reactors,  which  Member  States  are 
encouraged to develop in line with the principle of continuous improvement of safety, on the 
basis  of  the  safety  levels  developed  by  WENRA  and  in  close  collaboration  with  the  HLG. 
Based on the ten principles for the regulation  of nuclear safety adopted by it, the HLG will 
become the focal point for cooperation between the regulatory bodies charged with the safety 
of nuclear installations in the Member States and will contribute to the development of the EU 
nuclear safety framework. 

Member States are bound to respect the IAEA Safety Fundamentals, as well as the obligations 
and requirements as incorporated in the Convention on Nuclear Safety. 

7. ADDED VALUE 

With  the  renewed  interest  in  nuclear  energy  in  Europe  and  elsewhere,  it  is  important  to 
maintain a high degree of nuclear safety within the EU, to establish a set of binding rules and 
common  EU  safety  standards.  The  recent  announcement  of  new  build  of  NPPs  in  the  EU 
makes  convergence  rules  at  EU  level  even  more  necessary  in  order  to  support  the  Member 
States in their efforts to harmonise safety practices. Despite the existence of cross-border risks 
in the operation of nuclear installations, there has been only limited standardisation between 
countries in the past.  

Within this framework, the fundamental added value of the chosen policy option is that an 
EU  binding  legislative  framework  defining  basic  obligations  and  general  principles  on  the 
safety  of  nuclear  installations,  would  lead  to  the  attainment  of  the  objective  of  achieving, 
maintaining  and  continuously  improving  nuclear  safety  in  the  Community,  a  result  whose 
fulfillment at purely national level would not be as efficient. This approach also presents the 
clear  advantage  of  an  increased  certainty  of  regulation  at  Community  level.  Consequently, 
under  the  institutional  provisions  of  the  Euratom  Treaty,  Euratom  possesses  its  own 
mechanisms  to  ensure  the  compliance  of  the  national  laws  of  the  Member  States  with  the 
Directive's  provisions,  thus  exercising  its  role  of  safeguarding  the  correct  application  of  the 
Community acquis. Moreover, it should be highlighted that EU legislation confers rights and 
obligations not only for the authorities from each Member State, but as well as for individuals 
and  businesses.  The  authorities  in  each  Member  State  are  responsible  for  implementing  EU 
legislation  into  national  law  and  enforcing  it  correctly,  and  they  must  guarantee  citizens’ 
rights under these laws.  

In the absence of an EU legal framework, the IAEA Convention on Nuclear Safety would be 
applicable for Member States. However, the membership to the IAEA Convention on Nuclear 
Safety has only a voluntary character, as this Convention represents an incentive instrument 
and thus can not entail any sanctions for non-compliance. The Convention is not designed to 
ensure  the  fulfilment  of  obligations  by  Parties  through  control  and  sanction  but  is  based  on 
their  common  interest  to  achieve  higher  levels  of  safety,  which  will  be  developed  and 
promoted 
two  basic 
commitments for each Contracting Party: to prepare and make available a National Report for 
review and to subject its National Report to a peer review by the other Contracting Parties.  

the  Parties.  Membership  entails 

through  regular  meetings  of 

The elaboration of EU legislation on the basis of the principles of the Convention on Nuclear 
Safety  and  taking  full  advantage  of  the  safety  work  already  carried  out  by  the  IAEA  in 
defining Safety Fundamentals recognises the value of the international progress in the nuclear 
safety  area  and  offers  European  civil  society  a  possibility  to  become  more  involved  in  this 
field.  

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Finally,  the  proposal  also  aims  to  reinforce  the  role  and  the  independence  of  the  national 
regulatory  bodies  thereby  building  on  their  competencies,  rather  than  creating  a  top-down 
approach,  as  in  the  initial  nuclear  safety  proposal.  It  also  reinforces  the  role  of  the  national 
bodies  in  the  implementation  of  the  agreed  measures,  solution  which  is  in  full  compliance 
with the principle of subsidiarity.  

8. SUBSIDIARITY 

The EU Member States have already implemented measures enabling them to achieve a high 
level  of  nuclear  safety  within  the  EU.  However,  because  of  the  different  historical 
backgrounds,  legal  frameworks,  type  and  number  of  reactors  and  different  approaches  to 
regulation,  common rules in the field  of nuclear safety to  be applied  across the Community 
have not yet been established, although this would lead to a further improvement of nuclear 
safety, which could not be achieved exclusively at national level.  

The new proposal reverses the top-down approach of the 2003/2004 proposal to a bottom-up 
one,  as,  for  the  safety  of  new  nuclear  power  reactors,  Member  States  are  encouraged  to 
develop additional safety requirements, in line with the continuous improvement of safety on 
the basis of the safety levels developed by WENRA and in close collaboration with the HLG. 
In addition, Member States retain the right to impose at national level more stringent safety 
measures than those provided for in the Community legal framework. 

Secondly,  at  the  level  of  principles  proposed,  the  revised  Directive  is  anchored  on  the 
competence  existing  in  the  Member  States'  regulatory  authorities,  as  well  as  on  the 
internationally  accepted  principles  of  the  Convention  on  Nuclear  Safety  and  of  the  IAEA 
Safety  Fundamentals,  thus  not  imposing  any  additional  burden  on  the  Member  States' 
authorities.  

EU binding legislation also provides legal certainty by opening the possibility for citizens to 
turn to the European institutions in case they feel unsafe about nuclear energy. 

Moreover, it should be mentioned that the new proposal takes fully into account the Member 
States'  views  expressed  during  the  examination  of  the  2003/2004  package,  by  decoupling 
safety  from  nuclear  waste  and  financial  issues,  as  well  as  by  removing  the  idea  to  create  a 
Community  body  of  safety  inspectors  and  leaving  the  responsibility  of  nuclear  safety 
supervision solely to the national regulators. 

9. MONITORING AND EVALUATION 

The  indicators  of  progress  towards  meeting  the  objectives  will  be  set  up  at  the  level  of  the 
Member States. 

10. CONCLUSION 

In  the  framework  of  the  above  considerations,  the  chosen  policy  option  appears  to  be  the 
preferred  approach,  as  it  presents  the  highest  range  the  technical,  economical  and  security 
benefits, by going beyond the level of principles and actually encouraging Member States to 
define additional safety requirements. 

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