Proposal for a Council Directive (Euratom) setting up a Community framework for nuclear safety {SEC(2008) 2892} {SEC(2008) 2893}
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 
COM(2008) 790 final 

2008/0231 (CNS) 

Proposal for a  

COUNCIL DIRECTIVE (Euratom) 

setting up a Community framework for nuclear safety 

{SEC(2008) 2892} 
{SEC(2008) 2893} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

1.1. Grounds for and objectives of the proposal  

The present draft Directive setting up a Community framework on Nuclear Safety aims at re-
starting the process of establishing a common EU framework on nuclear safety, by updating 
and  replacing  the  Commission  proposal  for  a  Council  (Euratom)  Directive  setting  out  basic 
obligations and general principles on the safety of nuclear installations1, included in the initial 
Nuclear Safety Package.  

The  renewed  interest  in  nuclear  power  expressed  by  a  number  of  Member  States,  with  the 
perspective of numerous life extensions and construction of new plants, 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 
and citizens, but also wide ranging economic implications for the energy generating industry. 
Enacting in binding Community legislation internationally endorsed nuclear safety principles 
would ensure an additional level of guarantee for the public in the EU at large, by providing 
legal certainty. 

In  this  framework,  the  revised  legislative  proposal  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  the  nuclear  power  plants  in  the  EU;  c)  enshrining  in  the  Community  legislation  the 
principles of the main international instruments available, namely the Convention on Nuclear 
Safety  (CNS)2,  concluded  under  the  auspices  of  the  International  Atomic  Energy  Agency 
(IAEA), and the safety work carried out by the IAEA3.  

Its  basic  approach  is  that  a  set  of  common  principles  in  the  field  of  nuclear  safety,  already 
included in the CNS, are regulated at Community level, 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 European High Level 
Group on Nuclear Safety and Waste Management (HLG). Based on the ten principles for the 
regulation  of  nuclear  safety  adopted  by  it,  the  group  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. 

The  general  objective  of  the  proposal  is  to  achieve,  maintain  and  continuously  improve 
nuclear safety in the Community and to enhance the role of the regulatory bodies. Its scope of 
application is the design, siting, construction, maintenance, operation and decommissioning of 
nuclear  installations,  for  which  consideration  of  safety  is  required  under  the  legislative  and 

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COM(2003)32 final and COM(2004)526 final 
INFCIRC/449 
IAEA  Safety  Fundamentals:  Fundamental  safety  principles,  IAEA  Safety  Standard  Series  No.  SF-1 
(2006) 

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regulatory  framework  of  the  Member  State  concerned.  The  right  of  each  Member  State  to 
decide to use nuclear energy or not is recognised and fully respected. 

By  means  of  this  Community  nuclear  safety  framework,  several  operational  objectives  are 
envisaged  to  be  achieved,  namely  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 to the safety of nuclear installations, implementation of management systems, 
regular safety supervision, availability of nuclear safety expertise, priority to safety. 

1.2. General context 

At present, the interest in nuclear energy is undergoing a revival phase, due to a number of 
driving factors.  

The  EU  is  the  largest  nuclear  electricity  generator  in  the  world,  having  a  mature  nuclear 
industry,  spanning  the  entire  fuel  cycle  with  its  own  technological  base  and  highly  skilled 
workforce.  Nuclear  energy  is  currently  the  main  low-carbon  source  in  many  EU  Member 
States,  providing  more  than  a  third  of  the  EU  electricity,  and  it  has  proven  to  be  a  stable, 
reliable source, relatively shielded from price fluctuations when compared to the oil and gas 
markets. Continued use of nuclear energy therefore would contribute to the EU energy supply 
security  as  well  as  to  the  limitation  of  CO2  emissions,  but  it  is  also  still  confronted  with  a 
number of outstanding issues that need to be resolved. Nuclear energy plays an important role 
in  the  EU  energy  mix,  supported  by  a  firm  commitment  in  research  and  promotion  of 
technological developments, aimed at further enhancing its safety and security. 

The  continuous  improvement  of  the  safety  of  nuclear  installations  is  a  prerequisite  for  the 
acceptance of nuclear energy. Building on the existing work carried out under the auspices of 
the IAEA and bringing it within the Community framework would add value to the national 
approaches. Interlinking the national systems  and  the  Community  system  will  guarantee  the 
maintenance of a high level of safety for nuclear installations in the EU and will enhance the 
transparency of the EU regulatory mechanisms. In a long-term perspective, this shall result in 
an improved public confidence in the EU decision-making process on nuclear safety matters 
and bring legal certainty. 

1.3.  Existing  Community  instruments  advocating  for  nuclear  safety  harmonization  at 
EU level 

With  the  development  of  the  European  nuclear  industry,  convergence  at  Community  level 
became necessary in order to support the Member States in their efforts to harmonise safety 
practices. The Council Resolution of 22 July 1975 on the technological problems of nuclear 
safety4 recognised that it was the Commission's responsibility to act as a catalyst in initiatives 
taken at international level in the field of nuclear safety. This Resolution, while "taking into 
account  the  prerogatives  and  responsibilities  assumed  by  national  authorities",  makes 
reference  to  the  alignment  of  safety  requirements  in  the  context  of  a  desirable  harmonised 
approach at Community level. 
Against  this  background,  a  second  Council  Resolution  was  adopted  in  19925,  in  which  the 
Council  reaffirmed  the  intentions  of  the  1975  Resolution  and  invited  Member  States  to 
continue and intensify concerted efforts towards harmonization of safety issues. 

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OJ No C 185 of 14 August 1975, p. 1. 
OJ No C 172 of 8 July 1992, p. 2. 

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In addition, the support for the elaboration of Community nuclear safety legislation has been 
constantly  reflected  over  the  years  in  the  Council  Conclusions6  and  in  the  European 
Parliament  Reports7.  However,  binding  Community  legislation  in  the  area  of  nuclear  safety 
has not been adopted until present. 

1.4. Consistency of the proposal with other policies and objectives of the Union 

The  intrinsic  link  between  radiation  protection  and  nuclear  safety  was  recognised  by  the 
European  Court  of  Justice  in  its  ruling  in  the  Case  C-29/99,  according  to  which  “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". The Court has also confirmed that the Commission has competence to 
make recommendations for harmonising the measures required by Articles 18 and 19 of the 
CNS concerning the design, construction and operation of nuclear installations which can be 
the subject of the provisions which the Member States lay down to ensure compliance with 
the basic standards. The development of a Community approach in the field of nuclear safety 
would contribute to the full achievement of the objectives of the community acquis in the area 
of  radiation  protection,  namely  protecting  the  workers  and  the  general  public  against  the 
dangers  of  ionising  radiation  without  unduly  limiting  the  beneficial  uses  of  the  practices 
giving rise to radiation exposure. 

1.5. Initial Nuclear Safety Package 

On 30 January 2003, after receiving the opinion of the Group of Experts set up by Article 31 
of  the  Euratom  Treaty,  the  Commission  adopted  two  proposals  of  Directives  dealing 
respectively  with  the  safety  of  nuclear  facilities  and  the  management  of  spent  fuel  and 
radioactive waste8. 

After the European Economic and Social Committee gave its opinion on 26 March 2003, both 
proposals were forwarded to the Council. In accordance with the procedure in Article 31 of 
the  Euratom  Treaty,  the  Council  requested  the  opinion  of  the  European  Parliament,  which 
adopted opinions on the proposals in its plenary session on 13 January 2004. 

At  the  same  time,  both  proposals  were  discussed  in  the  Council,  under  the  Italian  and  Irish 
Presidencies. As a majority allowing the adoption or the rejection of both proposals was not 
possible  to  be  obtained,  it  was  agreed  that  Council  conclusions  would  be  worked  out  by 
consensus. Draft Conclusions on nuclear safety and on the safety of the management of spent 
nuclear fuel and radioactive waste were adopted by the Council in June 20049, leading to the 
creation of the Council Working Party on Nuclear Safety (WPNS). A detailed presentation of 
the  procedural  aspects  related  with  the  initial  Nuclear  Safety  Package  is  included  in  the 
Impact Assessment Report10 accompanying the present initiative. 

The  existing  proposal  of  a  Directive  dealing  with  the  safety  of  nuclear  facilities  will  be 
withdrawn and replaced by the new proposal. 

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Council Conclusions on nuclear safety and on the safety of the management of spent nuclear fuel and 
radioactive waste  (10823/04);  Council  Conclusions on Nuclear Safety and  Safe  management  of spent 
nuclear fuel and radioactive waste (8784/07) 
Maldeikis  report  on  the  50  years  of  the  Euratom  Treaty  (A6-0129/2007)  and  Reul  report  on 
conventional energies (A6-0348/2007) 
COM(2003) 32 final 
10823/04 
SEC(2008) 2892. 

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2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

2.1.  Stakeholders  consultations  on  the  necessity  of  a  Community  nuclear  safety 

legislative framework  

The  current  revised  legislative  proposal  is  the  result  of  an  extensive  and  continuous 
consultation process, initiated in 2004 during the Irish Presidency. The WPNS, the HLG and 
the European Nuclear Energy Forum continued work on this issue. 

Throughout the elaboration process of the initial Nuclear Safety Package, a wide consultation 
with the stakeholders on the opportunity of setting up a nuclear safety legislative framework 
was carried out at the initiative of the Commission, supplementing the consultations resulting 
from the legislative procedure provided for in the Euratom Treaty (the opinions of the Group 
of  experts  set  up  by  Article  31  of  the  Treaty  and  of  the  European  Economic  and  Social 
Committee). Consultations were also undertaken with international organizations, such as the 
IAEA and the OECD Nuclear Energy Agency (NEA). The Commission took also advantage 
of its participation in various international meetings to present its plans for EU regulation in 
the field of nuclear safety.  

The European Nuclear Energy Forum, established in 2007 and involving key decision-makers 
and organizations from national and EU levels, has already contributed to enhancing a better 
understanding  on  common  approaches  that  are  required  in  the  further  development  of  the 
safety  of  nuclear  installations.  The  Conclusions  of  the  Prague  and  Bratislava  2008  Forum 
meetings emphasised the Forum's strong support for the adoption of EU legislation on nuclear 
safety, based on "common fundamental safety principles for nuclear installations". 

In addition, the technical background supporting the basic principles proposed in the current 
draft  revised  Directive  was  provided  by  the  outcome  of  the  activity  of  the  different  expert 
groups  dealing  with  nuclear  safety  matters.  Several  different  levels  and  types  of  activities 
have  been  developed  at  EU  level,  with  the  involvement  of  expert  groups  comprising 
representatives of the safety authorities of the Member States, which have actively contributed 
to the harmonisation of nuclear safety practices.  

2.2.  Overview  of  the  expert  groups  in  the  field  of  the  harmonization  of  nuclear  safety 

approaches at EU level 

2.2.1.  Nuclear  Regulators’  Working  Group  (NRWG)  and  Reactor  Safety  Working  Group 

(RSWG) 

In  order  to  pursue  the  objectives  of  the  1975  Council  Resolution  on  the  technological 
problems  of  nuclear  safety,  the  Commission  set  up  two  expert  groups  dealing  with  nuclear 
installation  safety.  The  NRWG,  which  met  last  in  June  2005,  includes  representatives  of 
nuclear  regulatory  authorities  from  EU  Member  States  and  Candidate  States  of  Central  and 
Eastern Europe. The RSWG, which included all the EU regulatory bodies and industry, was 
discontinued in 1998.  

2.2.2. CONCERTation on European Regulatory Tasks (CONCERT) 

The CONCERT Group, formed in 1992, was a forum that brought together EU, Central and 
Eastern  European  Countries  and  Newly  Independent  States  nuclear  regulators  to  share 
experience and to enhance the progress of assistance and co-operation programmes in general. 
The group held its last meeting in 2005. 

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2.2.3. WENRA 

Special  emphasis  should  be  put  on  the  activity  carried  on  by  WENRA,  an  organisation 
comprising  the  Heads  and  senior  staff  members  of  nuclear  regulatory  authorities  from  17 
European Countries. 

In order to harmonise safety approaches, two working groups were launched with the mandate 
to  analyse  the  current  situation  and  the  different  safety  approaches,  compare  individual 
national  regulatory  approaches  with  the  IAEA  Safety  Standards,  identify  differences  and 
propose  a  way  forward  to  possibly  eliminate  the  differences  without  impairing  the  final 
resulting level of safety. 

In January 2006, reports on safety reference levels were published and subsequently revised 
in  2007  and  200811.  WENRA  members  have  defined  many  common  safety  reference  levels 
for  power  reactors  with  a  view  to  align  national  requirements  by  the  year  2010.  Any 
Community  initiative  in  the  field  of  nuclear  safety  should  take  advantage  of  the  technical 
progresses achieved within WENRA. Moreover, the WENRA reports on the harmonization of 
safety  approaches  for  nuclear  power  reactors  were  assessed  by  the  WPNS  which  concluded 
that  "WENRA  methodology 
to 
harmonisation".  

is  a  systematic,  documented  and 

logical  approach 

2.2.4. WPNS  

Following the 2004 Council Conclusions on nuclear safety and safe management of spent fuel 
and  radioactive  waste,  which  call  for  an  “extensive  consultation”  with  stakeholders,  a  wide 
ranging  consultation  process  was  initiated,  aiming  to  identify  new  instrument(s)  that  can 
contribute  more  effectively  to  further  improving  nuclear  safety  and  the  safety  of  the 
management of spent fuel and radioactive waste, in the framework of the Euratom Treaty and 
in line with the principles of better law making. As a result, the WPNS was established12. 
The  final  WPNS  Report13,  comprising  overall  conclusions  and  recommendations,  was 
approved  by  the  Council  on  13  December  2006.  The  detailed  methodology,  organisation  of 
work and data collection, detailed results from data collection and analysis, and justification 
for the conclusions and recommendations are presented in the reports produced by the three 
established subgroups14. 70 experts from Member States and the Commission participated at 
the work of the WPNS. The conclusions of these Reports offer a sound technical background 
for the approach envisaged by the current draft Directive setting up a Community framework 
for Nuclear Safety. 

2.2.5. HLG 

In  10  January  2007,  the  Commission  adopted  a  draft  Nuclear  Illustrative  Programme  that 
proposed the establishment of a High Level Group on nuclear safety, waste management and 
decommissioning.  Subsequently,  this  proposal  has  been  endorsed  and  supported  by  all  the 
highest  EU  fora  (as  reflected  in  the  Conclusions  of  the  Brussels  European  Council  from 
March  200715,  the  Council  Conclusions  of  May  2007  on  Nuclear  Safety  and  Safe 

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http://www.wenra.org 
WPNS has been activated by the Working Party on Atomic Questions (WPAQ) as a consequence of the 
Council  conclusions  on  Nuclear  Safety  and  Safe  management  of  spent  fuel  and  radioactive  waste 
(10823/04) 
15475/2/06 REV2 
15475/2/06 REV 2 ADD 1, 15475/2/06 REV 2 ADD 2, 15475/2/06 REV 2 ADD 3 
7224/1/07 REV 1 

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Management  of  Spent  Nuclear  Fuel  and  Radioactive  Waste16  and  in  the  2007  European 
Parliament Report on 50 years of European nuclear energy policy17).  
The HLG was formalised by the Commission Decision 2007/530/Euratom18 in July 2007. The 
Decision mandates the HLG to assist the EU institutions in progressively developing common 
understanding and eventually additional European rules in the fields of the safety of nuclear 
installations and the safety of the management of spent fuel and radioactive waste.  

The HLG comprises the Heads of the national regulatory or nuclear safety authorities of the 
27 Member States. By setting up the HLG, the technical work of WENRA will be widened in 
a more formal framework, in association with representatives of the EU non nuclear energy 
countries. 

The proposed draft Directive includes specific provisions on the actions to be implemented by 
the HLG, which will have a key role by supporting the definition of instruments to maintain 
and  further  improve  nuclear  safety  throughout  the  Community.  For  this  purpose,  upon  the 
adoption by the Council of the current Directive, the initial mandate of the Group, as set up in 
the Commission Decision 2007/530/Euratom will be amended by the Commission, in order to 
properly reflect its responsibilities in connection with the implementation of the Directive. 

2.3. Impact Assessment  

The accompanying Impact Assessment updates the Impact Assessment related to the previous 
nuclear  safety  proposal  included  in  the  Nuclear  Safety  Package19,  and  it  is  based  on  the 
technical conclusions and recommendations identified in the WPNS Reports, as well as on the 
obligations  and  requirements  set  up  in  the  CNS  and  on  the  principles  of  the  IAEA  Safety 
Fundamentals. 

The Impact Assessment analyses 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  enacting  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  being  elaborated  by  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 HLG. As a  result, the assessment of the options showed 
that the most efficient solution for setting up a Community nuclear safety common approach 
is  the  one  envisaged  by  Policy  option  3.  The  Impact  Assessment  Report  is  accessible 
on………. 

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8784/07 
A6-0129/2007 
O.J. L 195, 27/07/2007 P. 0044 - 0046 
COM 2003/32  

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3. 

LEGAL ELEMENTS OF THE PROPOSAL 

3.1. Summary of the proposed action 

The present proposal aims at re-starting the process of establishing a common EU framework 
on nuclear safety with the objective of achieving and maintaining a high comparable level of 
nuclear  safety  throughout  the  Community,  by  replacing  the  corresponding  initial  proposal 
included  in  the  Nuclear  Safety  Package.  The  proposal  is  anchored  on  the  provisions  of  the 
CNS,  which  sets  up  a  precise  legal  framework  representing  the  foundation  of  a  harmonised 
nuclear safety  system  and  to which Euratom and all the EU Member States are Contracting 
Parties. 

3.2. Legal basis 

The  legal  basis  for  this  proposal  is  Article  31  of  the  Euratom  Treaty,  in  connection  with 
Article  32  thereof.  Article  31  defines  the  procedure  for  the  adoption  of  the  basic  safety 
standards provided for in Article 30 for the protection of the health of workers and the general 
public against the dangers arising from ionising radiation. Article 32 explicitly states that the 
basic standards might be supplemented in accordance with the procedure laid down in Article 
31. 

3.3. Subsidiarity and proportionality  

Nuclear energy plays an important role in the transition to a low carbon economy and reduces 
EU external supply dependency. The choice to include nuclear energy in the energy mix lies 
with  the  Member  States.  The  role  of  the  European  Union  is  to  ensure  that  this  source  of 
energy is developed while meeting the highest level of safety. 

All  the  EU  Member  States  are  Contracting  Parties  to  the  CNS,  which  constitutes  an 
internationally recognised common platform for nuclear safety development. 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  been  yet 
established.  

The  approach  of  the  current proposal  allows Member States to fully exploit the subsidiarity 
principle as it creates a legislative framework for nuclear safety without being prescriptive as 
regards details. Moreover, the draft Directive aims to reinforce the role and the independence 
of the national regulatory bodies thereby building on their competencies, as well as the role of 
the national bodies in the implementation of the agreed measures. By means of the Directive, 
the principle of national responsibility for the safety of nuclear installations is fully adhered 
to, 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 draft Directive. 

4. 

MAIN PROVISIONS OF THE PROPOSAL 

4.1. Responsibility and framework for the safety of nuclear installations (Article 3) 

The  article  on  responsibility  for  the  safety  of  nuclear  installations  reflects  one  of  the 
fundamental  principles  of  nuclear  safety,  also  enshrined  in  Article  9  of  the  CNS:  the  prime 

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responsibility  for  the  safety  of  nuclear  installations,  throughout  their  lifetime,  rests  with  the 
holder  of  the  license  under  the  control  of  the  regulatory  body.  Furthermore,  the  safety 
measures and controls to be implemented in a nuclear installation shall be decided only by the 
regulatory body and realised by the licence holder.  

The  second  paragraph  requires  Member  States  to  establish  and  maintain  a  legislative  and 
regulatory framework for nuclear safety. This provision is already adhered to by all Member 
States and should not pose any difficulty for implementation. 

4.2. Regulatory bodies (Article 4) 

The text reinforces the role and the independence of the national regulatory bodies, building 
on their competencies. In order to facilitate autonomous decisions giving  priority to nuclear 
safety,  the  effective  independence  of  the  regulatory  body  from  all  organizations  tasked  to 
promote, operate nuclear installations or justify societal benefits, as well as its freedom from 
undue  influence  must  be  ensured.  A  similar  provision  already  exists  in  the  CNS  (Article  8 
paragraph  2).  The  regulatory  body,  provided  with  adequate  authority,  competence  and 
financial and human  resources  to fulfil its responsibilities  and  duties, will  be entrusted with 
the supervision and regulation of the safety of nuclear installations, as well as with ensuring 
of the implementation of safety requirements, conditions and regulations. 

The  regulatory  body  will  have  the  responsibility  of  granting  licences  and  monitoring  their 
application on siting, design, construction, commissioning, operation or decommissioning of 
nuclear installations.  

The regulatory body will have the duty to ensure that licence holder have staff in sufficient 
numbers and level of qualification to run the installations. 

In  order  to  continuously  improve  the  regulatory  infrastructure,  the  regulatory  body  and  the 
national regulatory structure will be subject to periodic international peer reviews. 

In the framework of this provision, the national regulatory bodies and the regulatory systems 
will  be  subject  to  regular  international  peer  review  missions  by  the  IAEA  International 
Regulatory  Review  Service  (IRRS)  missions,  and  subscribe  to  prepare  at  least  a  self 
assessment every ten years. 

4.3. Transparency (Article 5) 

The provisions of Article 5 respond to the necessity ensure access to reliable information and 
to allow the public to participate to a transparent decision-making process.  

4.4. Safety requirements and regulations for nuclear installations (Article 6) 

Article  6  reiterates  and  reinforces  Member  States'  obligation  to  respect  the  IAEA  safety 
fundamentals20 as well as to observe the internationally agreed obligations and requirements 
of the CNS. 

In  addition,  as  regards  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. 

20 

IAEA  Safety  Fundamentals:  Fundamental  safety  principles,  IAEA  Safety  Standard  Series  No.  SF-1 
(2006). 

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In  this  context,  it  should  be  underlined  that,  once  the  Council  has  agreed  on  the  text  of  the 
Directive, the Commission will adapt accordingly the mandate of the HLG as established by 
its founding Commission Decision.  

4.5. Obligations of licence holders (Article 7) 

This article sums up the obligations of licence holders for fulfilling the requirements set up in 
Article  6  and  emphasises  their  duties  to  establish  and  implement  management  systems  and 
possess adequate financial and human resources for nuclear safety. 

4.6. Supervision (Article 8) 

The  nuclear  safety  assessments,  investigations,  control  and  enforcement  actions  of  the 
regulatory body must be carried out throughout the whole lifetime of installations, including 
during decommissioning. This is another commonly agreed principle. In order to strengthen 
the  powers  of  European  regulators,  the  present  Directive  provides  for  extended  regulatory 
powers  in  the  interest  of  safety.  In  case  of  serious  or  repeated  safety  rules  breaches,  the 
regulatory  body  shall  have  the  power  to  withdraw  the  operating  licence  and  order  the 
suspension  of  operations  of  any  plant  if  it  deems  that  safety  is  not  fully  guaranteed.  The 
obligation of the assessment and verification of safety is also set up in Article 14 of the CNS. 

4.7. Nuclear safety expertise (Article 9) 

The availability of nuclear safety experts is an extremely important issue which comes up at 
every international meeting concerned with nuclear safety. The past decades have not trained 
enough  specialists,  so  that  there  is  also  the  problem  of  aging  of  safety  personnel  and 
inspectors, of which many are approaching retirement. This is an area where the Community 
can assist with encouraging trans-national cooperation and training. The obligation to ensure 
the availability of sufficient and qualified staff is also recognised in Article 11 paragraph 2 of 
the CNS.  

4.8. Priority to safety (Article 10) 

In line with the principle of priority of safety, Member States have the possibility to impose at 
national level more stringent safety measures than those provided for in the draft Directive. 

5. 

CONCLUSION 

The Council is, therefore, requested to: 

approve  the  attached  proposal  for  a  Council  Directive  (Euratom)  setting  up  a  Community 
framework for Nuclear Safety. 

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2008/0231 (CNS) 

Proposal for a  

COUNCIL DIRECTIVE (Euratom) 

setting up a Community framework for nuclear safety 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Atomic  Energy  Community,  and  in 
particular Articles 31and 32 thereof, 

Having regard to the proposal from the Commission, drawn up after obtaining the opinion of 
a  group  of  persons  appointed  by  the  Scientific  and  Technical  Committee  from  among 
scientific experts in the Member States21, 

Having regard to the opinion of the European Parliament22, 

Having regard to the opinion of the Economic and Social Committee23, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

Article 2(b) of the Treaty stipulates that the Community is to establish uniform safety 
standards  to  protect  the  health  of  workers  and  of  the  general  public  and  ensure  that 
they are applied. 

Article 30 of the Treaty provides that basic standards are to be laid down within the 
Community for the protection of the health of workers and the general public against 
the dangers arising from ionising radiations.  

For that purpose Council Directive 96/29/Euratom of 13 May 1996 laying down basic 
safety  standards  for  the  protection  of  the  health  of  workers  and  the  general  public 
against  the  dangers  arising  from  ionising  radiation24  establishes  the  basic  safety 
standards.  The  provisions  of  that  Directive  were  supplemented  by  more  specific 
legislation. 

Council Decision 87/600/Euratom of 14 December 1987 on Community arrangements 
for the early exchange of information in the in the event of a radiological emergency25 
established  a  framework  for  notification  and  provision  of  information  to  be  used  by 
the  Member  States  in  order  to  protect  the  general  public  in  case  of  a  radiological 
emergency. Council Directive 89/618/Euratom of 27 November 1989 on informing the 

21 
22 
23 
24 
25 

OJ C […], […], p. […] 
OJ C […], […], p. […] 
OJ C […], […], p. […] 
OJ L 159, 29.6.1996, p. 1. 
OJ L 371, 30.12.1987, p. 76. 

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general public about health protection measures to be applied and steps to be taken in 
the event of a radiological emergency26 imposed obligations on the Member States to 
inform the general public in the event of a radiological emergency. 

(5) 

Although  the  system  of  radiation  protection  established  by  the  existing  basic  safety 
standards, taking into account the current scientific knowledge, ensures a high level of 
protection for the health of the population, it should be further supplemented to ensure 
that  a  high  level  of  safety  of  nuclear  installations  is  maintained,  developed  and 
continuously  improved.  Keeping  up  a  high  level  of  safety  from  design  to 
decommissioning is a sine qua non condition in order to fully attain the objectives of 
health  protection  set  out  in  Article  2(b)  of  the  Treaty.  For  this  purpose  effective 
defences  against  radiological  risks  should  be  maintained  and  accidents  which  could 
have radiological consequences should be prevented. 

(6)  While  each  Member  State  is  free  to  decide  on  its  energy  mix,  after  a  period  of 
reflection,  interest  in  the  construction  of  new  plants  has  grown  and  some  Member 
States  decided  to  licence  new  plants.  Furthermore,  requests  for  nuclear  power  plant 
life extensions are expected to be presented by licence holders in the years to come. 

(7) 

(8) 

(9) 

For this purpose best practices should be developed to guide the regulatory bodies in 
their decisions on the lifetime extension of nuclear installations. 

The  Member  States  have  already  implemented  measures  enabling  them  to  achieve  a 
high level of nuclear safety within the Community. 

The continuous improvement of nuclear safety requires that the management systems 
established  and  the  licence  holders  ensure  the  high  level  of  safety  for  the  general 
public. 

(10)  Fundamentals  and  requirements  set  by  the  International  Atomic  Energy  Agency 
(IAEA)  constitute  a  framework  of  practices  on  which  national  safety  requirements 
should  be  based.  Member  States  have  made  considerable  contributions  to  the 
improvement of those fundamentals and requirements.  

(11)  The national safety authorities of the Member States having nuclear power plants on 
their  territory  have  worked  together  in  the  context  of  Western  European  Nuclear 
Regulators' Association (WENRA) and have defined many common safety reference 
levels for power reactors with a view to align national requirements by the year 2010. 

(12)  Despite existing harmonisation, the nuclear safety procedures and practices still vary 
from  one  Member  State  to  another.  At  present,  the  diversity  of  measures  does  not 
ensure that the health protection requirements of Article 2(b) of the Treaty are applied 
in  the  most  coherent  way  in  the  Community.  The  European  Atomic  Energy 
Community by joining the Convention on Nuclear Safety, which entered into force on 
24  October  1996,  committed  itself  to  observing  an  internationally  recognised  high 
level of nuclear safety27. In order for the Community to ensure that the principles of 

26 
27 

OJ L 357, 7.12.1989, p. 31. 
The  Interinstitutional  Agreement  on  inter-institutional  co-operation  in  the  framework  of  international 
Conventions  to  which  the  European  Atomic  Energy  Community  and  its  Member  States  are  parties 
applies in this context. 

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this Convention are given effect at Community level and that uniform safety standards 
as required by Article 2(b) of the Treaty are applied, the basic standards for radiation 
protection should be supplemented by common safety principles. 

(13)  The  provision  of  information  to  the  public  in  an  accurate  and  timely  manner  about 
important  nuclear  safety  matters  should  be  based  on  high  level  of  transparency  on 
issues relating to the safety of nuclear installations. 

(14)  National responsibility of Member States for the safety of nuclear installations is the 
fundamental  principle  on  which  nuclear  safety  regulation  has  been  developed  on  the 
international level, as endorsed by the Convention on Nuclear Safety. This principle of 
national responsibility as well as the principle of prime responsibility for the safety of 
a  nuclear  installation  which  rests  with  the  licence  holder  under  the  control  of  its 
national regulatory body should be enhanced by this Directive. 

(15) 

In  order  to  ensure  the  effective  implementation  of  safety  requirements  for  nuclear 
installations,  Member  States  should  establish  regulatory  bodies  as  independent 
authorities.  Regulatory  bodies  should  be  provided  with  adequate  competence  and 
resources in order to be able to discharge their duties. 

(16) 

In order to ensure an effective implementation of this Directive, Member States should 
report to the Commission at regular intervals. Intervals of three years are appropriate 
in the light of the requirements of the Convention on Nuclear Safety. 

(17) 

In order to continuously improve nuclear safety the Commission, if appropriate, may 
present proposals for adoption by the Council. 

(18)  The  European  High  Level  Group  on  Nuclear  Safety  and  Waste  Management  was 
created28 to contribute to the achievement of the Community objectives in the field of 
nuclear safety. For this purpose it should support the development of instruments that 
are necessary to maintain and continuously improve nuclear safety and that should be 
siting,  construction,  maintenance,  operation  and 
applied 
decommissioning  of  nuclear 
installations,  for  which  compliance  with  safety 
requirements  is  required  under  the  legislative  and  regulatory  framework  of  the 
Member State concerned.  

the  design, 

to 

(19)  The regulatory bodies charged with the safety of nuclear installations in the Member 
States  should  mainly  cooperate  through  the  European  High  Level  Group  on  Nuclear 
Safety and Waste Management which has developed ten principles for the regulation 
of  nuclear  safety.  The  European  High  Level  Group  on  Nuclear  Safety  and  Waste 
Management should contribute to the Community nuclear safety framework with the 
aim of continuously improving it. 

28 

O.J. L 195, 27/07/2007 P. 0044 - 0046 

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HAS ADOPTED THIS DIRECTIVE: 

Article 1 
Objective and scope 

1. This Directive aims at achieving, maintaining and continuously improving nuclear safety in 
the Community and to enhance the role of the national regulatory bodies. 

the  design,  siting,  construction,  maintenance,  operation  and 
2.  It  shall  apply 
decommissioning of nuclear installations, for which consideration of safety is required under 
the legislative and regulatory framework of the Member State concerned. 

to 

3. This Directive is without prejudice to the Council Directive 96/29/Euratom. 

4. This Directive is without prejudice to the right of each Member State to decide whether to 
operate its own civil nuclear programme or not . 

Article 2 
Definitions 

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

"nuclear  installation”  means  a  nuclear  fuel  fabrication  plant,  research  reactor 
(1) 
(including subcritical and critical assemblies), nuclear power plant, spent fuel storage facility, 
enrichment plant or reprocessing facility; 

“nuclear  safety”  means  the  achievement  of  proper  operating  conditions  through 
(2) 
measures  taken  with  a  view  to  the  prevention  of  accidents  or  mitigation  of  accident 
consequences,  resulting  in  protection  of  workers,  general  public  and  the  air,  water  and  soil 
from undue radiation hazards arising from nuclear installations; 

(3) 
“radioactive  material”  means  any  material  containing  one  or  more  radionuclides  the 
activity  or  concentration  thereof  cannot  be  disregarded  as  far  as  radiation  protection  is 
concerned; 

(4) 
"decommissioning"  means  administrative  and  technical  actions  taken  to  allow  the 
removal  of  some  or  all  of  the  regulatory  controls  from  a  nuclear  installation,  except  for  a 
repository  or  for  certain  nuclear  facilities  used for  the  disposal  of  residues  from  the  mining 
and processing of radioactive material, which are closed and not decommissioned; 

"radioactive  waste"  means  radioactive  material  in  gaseous,  liquid  or  solid  form  for 
(5) 
which no further use is foreseen by the Member State, and which is controlled as radioactive 
waste  by  a  regulatory  body  under  the  legislative  and  regulatory  framework  of  a  Member 
State; 

(6) 
"spent fuel" means nuclear fuel that has been irradiated in and permanently removed 
from  a  reactor  core;  spent  fuel  may  either  be  considered  as  usable  resource  that  can  be 
reprocessed  or  be  destined  for  final  disposal  with  no  further  use  foreseen  and  treated  as 
radioactive waste; 

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(7) 
“ionising  radiation”  means  the  transfer  of  energy  in  the  form  of  particles  or 
electromagnetic waves of a wavelength of 100 nanometer or less or a frequency of 3 x 1015 
Hertz or more capable of producing ions directly or indirectly;  

”regulatory body" means any body or bodies authorised by the Member State to grant 
the  siting,  design,  construction, 
to  supervise 

(8) 
in 
licences  and 
commissioning, operation or decommissioning of nuclear installations; 

that  Member  State 

"licence" means any authorisation granted by  the regulatory body to the applicant to 
(9) 
confer  the  responsibility  for  the  siting,  design,  construction,  commissioning,  operation  or 
decommissioning of nuclear installations; 

“new power reactors” mean nuclear power reactors licensed to operate after the entry 

(10) 
into force of this Directive. 

Article 3 
Responsibility and framework for the safety of nuclear installations 

1. The prime responsibility for the safety of nuclear installations shall rest with the holder of 
the license under the control of the regulatory body. The safety measures and controls to be 
implemented in a nuclear installation shall be decided only by the regulatory body and applied 
by the licence holder. 

The licence holder shall have the prime responsibility for safety throughout the lifetime of the 
nuclear installations until its release from regulatory control. This responsibility of the licence 
holder cannot be delegated. 

2.  Member  States  shall  establish  and  maintain  a  legislative  and  regulatory  framework  to 
govern  the  safety  of  nuclear  installations.  This  shall  include  national  safety  requirements,  a 
system of licensing and control of nuclear installations and the prohibition of their operation 
without a licence and a system of regulatory supervision including the necessary enforcement. 

Article 4 
Regulatory bodies 

1. 
Member States shall ensure that the regulatory body is effectively independent of all 
organisations  whose  task  is  to  promote,  operate  nuclear  installations  or  justify  societal 
benefits and free from any influence that may affect the safety. 

2. 
The  regulatory  body  shall  be  provided  with  adequate  authority,  competence  and 
financial  and  human  resources  to  fulfil  its  responsibilities  and  discharge  its  duties.  It  shall 
supervise  and  regulate  the  safety  of  nuclear  installations  and  ensure  the  implementation  of 
safety requirements, condition and safety regulations. 

The  regulatory  body  shall  grant  licenses  and  monitor  their  application  on  siting, 

3. 
design, construction, commissioning, operation or decommissioning of nuclear installations. 

Regulatory bodies shall ensure that licence holders have at their disposal appropriate 

4. 
staff in terms of numbers and qualifications. 

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5. 
At  least  every  ten  years  the  regulatory  body  shall  submit  itself  and  the  national 
regulatory  system  to  an  international  peer  review  aimed  at  continuously  improving  the 
regulatory infrastructure. 

Article 5 
Transparency 

Member States shall inform the public about the procedures and the results of the surveillance 
activities  on  nuclear  safety.  They  shall  also  ensure  that  the  regulatory  bodies  effectively 
inform the public in the fields of their competence. Access to information shall be ensured, in 
accordance with relevant national and international obligations. 

Article 6 
Safety requirements and regulations for nuclear installations 

Member  States  shall  respect 

1. 
the  IAEA  safety  fundamentals  (IAEA  Safety 
Fundamentals: Fundamental safety principles, IAEA Safety Standard Series No. SF-1 (2006)). 
They  shall  observe  the  obligations  and  requirements  incorporated  in  the  Convention  on 
Nuclear safety (IAEA INFCIRC 449 of 5 July 1994). 

They  shall  in  particular  ensure  that  the  applicable  principles  laid  down  in  the  IAEA  safety 
fundamentals  are  implemented  to  ensure  a  high  level  of  safety  in  nuclear  installations, 
including  inter  alia  effective  arrangements  against  potential  radiological  hazards,  accident 
prevention  and  response,  ageing  management,  long  term  management  of  all  produced 
radioactive  materials  and  information  of  the  population  and  the  authorities  of  neighbouring 
States. 

2. 
As  regards  the  safety  of  new  nuclear  power  reactors  Member  States  shall  aim  to 
develop additional safety requirements, in line with the continuous improvement of safety on 
the  basis  of  the  safety  levels  developed  by  the  Western  European  Nuclear  Regulators' 
Association  (WENRA)  and  in  close  collaboration  with  the  European  High  Level  Group  on 
Nuclear Safety and Waste Management. 

Article 7 
Obligations of licence holders 

Licence  holders  shall  design,  construct,  operate  and  decommission  their  nuclear 

1. 
installations in accordance with the provisions set out in Article 6(1) and (2). 

Licence  holders  shall  establish  and  implement  management  systems  which  shall  be 

2. 
regularly verified by the regulatory body. 

Licence  holders  shall  allocate  adequate  financial  and  human  resources  to  fulfil  their 

3. 
obligations. 

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Article 8 
Supervision 

Nuclear  safety  assessments, 

1. 
investigations,  controls  and,  where  necessary, 
enforcement  actions  shall  be  carried  out  by  the  regulatory  body  in  nuclear  installations 
throughout their lifetime, including during decommissioning. 

The regulatory body shall have the power to withdraw the operating licence in case of 

2. 
serious or repeated safety rules breaches in the nuclear installation. 

The regulatory body shall have the power to order the suspension of operations of any 

3. 
nuclear plant if it deems that safety is not fully guaranteed. 

Article 9 
Nuclear safety expertise 

Appropriate  education  and  training  opportunities  for  continuous  theoretical  and  practical 
training  in  nuclear  safety  shall  be  made  available  by  Member  States  separately  and  through 
trans-national cooperation. 

Article 10 
Priority to safety 

Member  States  may  lay  down  more  stringent  safety  measures  than  those  laid  down  in  this 
Directive. 

Article 11 
Reporting 

Member  States  shall  submit  a  report  to  the  Commission  on  the  implementation  of  this 
Directive  by  [three  years  after  the  entry  into  force]  at  the  latest,  and  every  three  years 
thereafter.  On  the  basis  of  the  first  report,  the  Commission  shall  present  a  report  to  the 
Council  on  progress  made  with  the  implementation  of  this  Directive,  accompanied,  if 
appropriate, by legislative proposals. 

Article 12 
Transposition 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative  provisions 
necessary to comply with this Directive by [two years after the date referred to in Article 13] 
at the latest. They shall forthwith communicate to the Commission the text of those provisions 
and a correlation table between those provisions and this Directive. 

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

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

Article 13 
Entry into force 

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

Article 14 
Addressees 

This Directive is addressed to the Member States. 

Done at Brussels, 

For the Council 
The President 

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