EN    EN EN 
 
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 26.11.2008 
SEC(2008) 2892 
  
COMMISSION STAFF WORKING DOCUMENT 
Accompanying document to the 
 
Proposal for a 
 
COUNCIL DIRECTIVE (Euratom) 
 
setting up a Community framework for Nuclear Safety 
 
IMPACT ASSESSMENT   
{COM(2008) 790 final} 
{SEC(2008) 2893} 
 
EN 2   EN TABLE OF CONTENTS 
Executive summary .............................................................................................................. ...... 3 
Section 1: Procedural issues and c onsultation of interested parties ........................................... 6 
Section 2: Problem definition.................................................................................................. ... 9 
Section 3: Objectives.......................................................................................................... ...... 20 
Section 4: Policy options...................................................................................................... .... 21 
Section 5: Analysis of impacts................................................................................................. 22 
Section 6: Comparing the options ............................................................................................ 33 Section 7: Monitoring and evaluation ...................................................................................... 36 ANNEX Overview of the consultations and techni cal expertise supporting the approach of the 
proposed Directive setting up a Commun ity framework for Nuclear Safety........................... 36 
1. Consultations within the framework of the first Nuclear Safety Package ........................... 36 2. Overview of the activity of expert groups in the field of the harmonization of nuclear safety 
approaches.................................................................................................................. 38 
 
EN 3   EN EXECUTIVE SUMMARY  
This Impact Assessment re lates to the agenda pl anning item 2008/TREN/003 - Revised 
legislative proposal on nuclear safety . It accompanies the draft revised Directive setting up a 
Community framework for Nuclear Safety. This re vised initiative in the area of nuclear safety 
aims to re-launch the process of establishi ng a common EU framewor k on nuclear safety, by 
replacing the proposed Directive setting out basi c obligations and general principles on the 
safety of nuclear installations1 presented by the Commission in  2003 (the chronology of the 
procedural steps undertaken in the framework of the initial nuclear safety legislative package 
is presented under Section 2.5.5.). This new proposal is the re sult of an extensive and 
continuous consultation process, initiated in  2004 during the Irish Presidency. The Council 
Working Party on Nuclear Safety (WPNS) , the European High Level Group on Nuclear 
Safety and Waste Management  (HLG) and the European Nuclear Energy Forum continued 
work on this issue. 
The HLG, created by the Commission in 2007, as  well as the European Nuclear Energy 
Forum, have already contributed to enhanc ing a better understanding  on common approaches 
that are required in the further development of the safety of nuclear installations. This will 
lead to an improved transparency to revi ew and communicate nuc lear issues, involving 
market participants, European institutions, Member States' representatives and other 
stakeholders of the civil society (e.g. NGOs). 
The consultation process that started in 2004 ha s 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 present revised proposal build s on: a) the technical work of the Western 
European Nuclear Regulators Association (WEN RA) 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 European legislation the principles of the 
main international instrume nts available, namely the Convention on Nuclear Safety
2 and the 
safety work carried out by the International At omic Energy Agency (IAEA), particularly its 
safety fundamental principles3. In relation to the Member States' support for re-launching a 
revised nuclear safety legislativ e proposal, it should be noted th at this new proposal benefits 
from the solid support of the current Council Pr esidency. A number of Member States which 
were initially opposed to the 2004 initiative, due to their concerns on enacting Community 
rules in this area, have now openly changed their position. The European Parliament has 
constantly supported the setting up of European nuclear safety legislation establishing reference levels, as illustrated over the years in its Reports
4. 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.  
                                                 
1 Initial 2003 Commission proposal (COM 2003/32 fi nal) and revised 2004 version (COM (2004)526 
final) 
2 IAEA INFCIRC 449 of 5 July 1994 
3 IAEA Safety Fundamentals: Fundamental safety pr inciples, IAEA Safety St andard Series No. SF-1 
(2006) 
4 See Section 2.5.4. for details. The latest were th e Maldeikis report on the occas ion of 50 years of the 
Euratom Treaty and the Reul report on conventional energies. 
 
EN 4   EN This revised proposal creates a legislative framework for nuc lear safety without being 
prescriptive as regards details. Within this framework, which recognises their sovereign right 
to use nuclear energy or not, Member States are fr ee to fully exploit the subsidiarity principle. 
The renewed interest in nuclear power expres sed by a number of Member States, with the 
perspective of numerous life extensions and new build, make s 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 implicati ons for the energy generating industry.  
Public acceptance is a prerequi site for the further developmen t of nuclear energy and so far 
the Community has been consistently active in promoting nuclear safety, as yet there is no 
Community legal framework govern ing the safety of nuclear installations. However, the 
European citizens’ concerns about the safety  of nuclear installations must be properly 
addressed by the Community, based on its recognis ed competencies in the field, as 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 wh ether 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%). As the prot ection of the EU public is one of the main 
political objectives of the EU, a legal framework aiming to the achievement of a high level of 
nuclear safety in the Community, as well as to  its permanent developm ent, would create an 
additional level of guarantee for the public in the EU, by providing legal certainty.  
The Impact Assessment updates the 2003 Impact Assessment related to the initial nuclear 
safety proposal6, having as technical background the conclusions and recommendations 
identified in the Final Report of the WPNS7, approved by the Council Working Party on 
Atomic Questions (WPAQ) on 13 December 2006 and complemented with the findings of the 
WPNS subgroups' reports8. The WPNS comprised 70 experts fr om the EU Member States and 
from the Commission.  
In this context, a special emphasis should be put  on the activity carried on in the framework of 
WENRA, an organisation comprising the Heads and senior staff members of the Nuclear 
Regulatory Authorities from 17 European C ountries, whose 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 this field should take advantage of the 
technical progresses achie ved within WENRA.  
Secondly, the Impact Assessment is based on the obligations a nd requirements of the IAEA 
Convention on Nuclear Safety, wh ich constitutes an internati onally 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 se ts up a precise legal 
framework aiming to the continuous improvement of safety. Euratom and all the EU Member 
States are Contracting Parties to the Conven tion on Nuclear Safety. The IAEA fundamentals 
                                                 
5 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 
6 COM 2003/32 final 
7 15475/2/06 REV2 (http://register.consilium.eu ropa.eu/pdf/en/06/st15/st15475-re02.en06.pdf) 
8 15475/2/06 REV 2 ADD 1 ( http://register.consilium.europa.eu/pdf/en/06/st15/st15475-
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) 
 
EN 5   EN constitute a framework of practices on which national safety requirements are based and to 
the improvement of which Member States have made considerable contributions. 
The above-mentioned documents have already c onfirmed and provided an  in-depth technical 
background for the basic principles included in the proposed revised Directive, whose general 
objective  is to set up a framework aiming to ach ieve, maintain and continuously improve 
nuclear safety and its regulati on in the Community, as well as to enhance the role of the 
Member States' regulatory bodies. 
The Impact Assessment considers four policy options : Policy option 0  consists in keeping the 
current situation unchanged; Policy option 1  envisages the elabor ation of Community 
legislation establishing comm on safety standards for existing nuclear installations; Policy 
option 2  consists in the elaboration of Commun ity legislation that sets up only a common 
framework aiming at achieving and maintaini ng a high uniform level of nuclear safety 
throughout the Community by reca lling widely recognised nucle ar safety principles; the 
subsequent implementing measures will be prepared within the HLG. Policy option 3  is built 
upon a set of internationa lly-recognised nuclear safety principles (a pproach 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, co mprising high-level representatives of the 
regulatory and safety authorities from all the EU Member States. 
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 nu clear safety, already included in the IAEA 
Convention on Nuclear Safety (enha ncing the role of national regu lators, prime responsibility 
of the licence holder for safety under the co ntrol of the regulatory body, reinforcing the 
independence of the regulatory body, ensuring a hi gh level of transparency on issues related 
to the safety of nuclear installations, implemen tation of management systems, regular safety 
supervision, availability of nuclear safety expe rtise, priority to safety), supplemented with 
additional safety requirements for new nuclear  power reactors, which Member States are 
encouraged to develop in line w ith the principle of continuous improvement of safety, on the 
basis of the safety levels de veloped 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 th e regulatory bodies charged with the safety 
of nuclear installations in the Member States a nd will contribute to the development of the EU 
nuclear safety framework. Member States are bound to respect the obligations and 
requirements as incorporated in  the Convention on Nuclear Safety  and the principles of the 
IAEA Safety Fundamentals. 
This approach marks a complete reversal of th e line put forward in the initial Nuclear Safety 
draft Directive, as it aims to reinforce the role and the indepe ndence of the national regulatory 
bodies thereby building on their co mpetencies, as well as to stre ngthen the role of the national 
bodies in the implementation of the agreed measures. 
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, establishing a set of binding rules. 
Despite the existence of cross-border risks in the operation of nuclear installations, there has 
been only limited harmonization between countrie s in the past. Within this framework, the 
fundamental added value  of this policy option is that an  EU binding legislative framework 
 
EN 6   EN defining basic obligations and general principles  on the safety of nuclear installations, would 
lead to the attainment of th e objective of achievi ng, maintaining and continuously improving 
nuclear safety in the Community, a result whos e 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 Dir ective'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 a nd obligations not only fo r the authorities from 
each Member State, but as well as for individuals and businesses. The authorities in each Member State are responsible for implemen ting EU legislation into national law and 
enforcing it correctly, and they must gua rantee citizens’ rights under these laws.  
In the absence of an EU legal framework, th e IAEA Convention on Nuclear Safety would be 
applicable for Member States. However, the me mbership to the IAEA Convention on Nuclear 
Safety has only a voluntary char acter, as this Convention repr esents an incentive instrument 
and thus can not entail any sanctions for non- compliance. The Convention is not designed to 
ensure the fulfilment of oblig ations by Parties through contro l and sanction but is based on 
their common interest to achieve higher levels  of safety, which will be developed and 
promoted through regular meetings of the Partie s. The Membership to this Convention entails 
two basic commitments for each Contracting Part y: to prepare and make available a National 
Report for review and to subjec t its National Report to a peer review by the other Contracting 
Parties. Being a Contracting Party to this C onvention implies including in the National Report 
a self-assessment of the steps and measures al ready taken and in progress to implement the 
Convention's obligations, taking an  active part in the review of  its National Report and the 
Reports of other Contracting Pa rties and a commitment to a continuous improvement process.  
The elaboration of EU legisla tion on the basis of the principl es 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 valu e of the international progress in the nuclear 
safety area and offers European civil society a possibility to become more involved in this 
field.  
Finally, the proposal also aims to reinforce the role and the indepe ndence of the national 
regulatory bodies and the role of the nationa l bodies in the implementation of the agreed 
measures, solution which is in full compliance with the principle of subsidiarity.  
S
ECTION 1: PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES  
1.1. Organisation and timing 
The elaboration of a revised legislative proposal on nuclear safety  is included in the 
Commission's  agenda planning 2008 – Commission actions  expected to be adopted in the 
period 01/02/2008 - 31/12/2008 (item 2008/TREN/003).  For the purpose of finalising the 
current accompanying Impact Assessment, a Steering Group was set up, composed of representatives of all the interested services  (DG ENV, DG ECFIN, DG RTD, JRC, SJ, SG). 
The Impact Assessment Board has assessed the draft Impact Assessment submitted to their 
attention in August 200 8 and issued an initial opinion on 9 September 2008, which included 
the following general recommendations:  
– The report should strengthen the rationale for this initiative by better explaining its 
European dimension and added value. This  should be done, on the one hand, by assessing 
more clearly how this initiati ve could contribute to the implementation of the Member 
States' commitments under the Convention on Nuclear Safety; on the other hand, by 
 
EN 7   EN presenting the potentially negative effects of the current differences between the national 
safety standards of the Member States on the overall level of nuclear safety in the EU and on the smooth functioning of the internal market.  
– Secondly, the report should explain the division of regulatory competences in the field of 
nuclear safety between the EU, HLG and Member  States. The role of the HLG as regards 
the adoption of implementing measures  in future should be clarified.  
– Thirdly, the overall coherence of the report should be stre ngthened by providing stronger 
links between problems, objectiv es, options and monitoring.  
– Finally, the political context of  this initiative should be be tter explained. The report should 
clarify how the current initiative differs from the nuclear  safety proposals that were put 
forward in 2003/2004. In that context, the repo rt should explain why a public consultation 
on this initiative was not considered necessary. 
Based on these main remarks, the Board requested  to receive a revised draft of the Report, on 
which it will then i ssue another opinion.  
As a follow-up, the Impact Assessment has been  revised accordingly, in order to respond to 
the aspects raised by the Board. In relation to th e previous version, additional information was 
included in the Executive Summary, as well as in  the Sections 2, 3, 4 and 5 of the document. 
The added information strengthens mainly the following aspects: 
– the political context of th e current revised proposal; 
– the description of the consultation with the stakeholders on a legislative framework on 
nuclear safety, in line with the Commi ssion minimum standards for consultation; 
– the main differences of the current revised approach in relation to the previous draft 
Directive dealing with the safety of nuclear installations included in the Nuclear Safety Package; 
– the added value of the proposed revised Di rective and its relation with the IAEA 
Convention on Nuclear Safety; 
– the envisaged division of regulatory competen cies between the EU institutions, the HLG 
and the Member States; 
– the definition of the concept "nuclear safety"; 
– the update of the estimations with the re sults of the latest 2007 DGTREN forecasts; 
– the coverage of the proposed Eur opean safety reference levels. 
After the re-submission of the revised draft Im pact Assessment, the Impact Assessment Board 
has issued its final opinion on 14 Octobe r 2008, which included the following general 
recommendations for improvement: 
– The report should, as a general comment, bette r explain the added value of the initiative 
and provide greater clarity on the procedure envisaged for adopting new safety reference 
levels. Specifically for explaining the added va lue, the report should be more explicit on 
whether the varying standards have an impact on the functioning of the internal market or 
raise safety concerns. 
– The links between problems, objectives, options  and monitoring should be more coherent. 
– The definition of regulatory competences be tween the EU, the HLG and Member states 
should be explained better. 
 
EN 8   EN – The executive summary should be more conc ise and the report should refrain from 
concluding on the actions needed in  the problem definition section. 
In the light of these recommendations, the draft Impact Assessment has been revised 
accordingly, in order to respond to the issues raised by the Board. In relation to the first 
version, the Executive Summary was shortened a nd changes were made mainly in Section 2 
of the document. The added information stre ngthens especially the following aspects: 
– the added value of the initiative; 
– the analysis of the compliance wi th the subsidiarity principle; 
– the procedural aspects related with the future implementing measures. 
As a result of the comments received from the Commission services on the text of the draft 
Nuclear Safety Directive and on the accomp anying Impact Assessment within the Inter-
Service consultation, the text of  the present document has been further amended accordingly. 
1.2. Consultation and expertise  
The current draft Directive sett ing up a Community framework for Nuclear Safety aims to re-
launch the Commission's initiative of enacting bi nding legislation in the field, by updating and 
replacing the corresponding proposal fr om the Nuclear Safety Package. 
Throughout the elaboration process of the initial Nuclear Safety Package in 2003 and 2004, 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 pr ocedure provided for in the Euratom Treaty (the 
opinions of the Group of experts set up by Ar ticle 31 of the Euratom Treaty and of the 
European and Social Committee).  
The Commission proposal to have an exchange of  views on the contributi on of nuclear energy 
in meeting the growing concerns about secur ity of energy supply, reduc tion of CO2 emissions 
and competitiveness, while taking fully into a ccount nuclear safety and security aspects was 
endorsed by the Heads of State and Government  reunited in the European Summit of 8 and 9 
March 20079. As a concrete follow-up, the European  Nuclear Energy Forum was established, 
to which high representative s from Governments, several Members of the European 
Parliament representing differe nt political groups and the European Economic and Social 
Committee participated actively, as well as the Presidents and CEOs of major companies, 
representatives from energy in tensive consumers, NGOs and Trade Unions, and other key 
decision makers and organisati ons at national and EU level. The Conclusions of the 2nd 
Prague Forum emphasised the Forum's strong s upport for the adoption of EU legislation on 
nuclear safety based on "common fundamental safety principles for nuclear installations"  
stating furthermore that "if it succeeds in adopting such a legal framework, Europe can 
become a real model also for possible nuclea r newcomers, ensuring that they take all 
necessary measures for ensuring the highest sa fety and security levels before developing 
nuclear infrastructure". 
In addition, the technical backgr ound supporting the basic principl es proposed in the current 
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. Several different levels and types of activ ities have been developed at EU level, with 
the involvement of expert gr oups. These groups, comprising re presentatives of the safety 
                                                 
9 Presidency conclusions (7224/1/07 REV 1) 
 
EN 9   EN authorities of the Member States, have activel y contributed to the ha rmonisation of nuclear 
safety practices.  
A detailed report on the consulta tions undertaken in the framew ork of the previous Nuclear 
Safety Package, as well as on the work of th e various expert working groups in the field of 
harmonization of nuclear safety approaches within the EU is presented in the Annex  of the 
Impact Assessment. These extensive consultati ons are in line with the Commission minimum 
standards for consultation, allo wing the public to be informed and actively involved in the 
preparation of the legislative initiative. 
SECTION 2: PROBLEM DEFINITION  
2.1. The problem that requires action 
The main purpose of the Euratom Treaty was to supervise the secure management of nuclear 
installations, including a high sta ndard of health protection. A br oad set of specific measures, 
distinct from those which had evolved under the auspices of the IAEA, has been developed in 
the field of radiation protection.  
Nuclear Safety can be defined as the achieve ment of proper operating conditions through 
measures taken with a view to the prevention of accidents or mitigation of accident consequences, resulting in the pr otection of workers, the public an d in the air, water and soil 
from undue radiation hazards aris ing from nuclear installations . Paradoxically, the safety of 
nuclear installations has not de veloped in the same way as ra diation protecti on, although it is 
supposed to provide concrete gua rantees for protecting population against ionising radiation, 
an area in which the Commission has, for a nu mber of years, had undeniable technological 
expertise through the Joint Research Centre  (JRC) and the Framework Programme for 
research and technological development. However,  the Community has actively intervened in 
connection with the harmonisation of nuclear safety practices fo r over 25 years, in particular 
under the Council Resolutions of 22 July 1975
10 and 18 June 199211 on the technological 
problems of nuclear safety. Although the establis hed system of radiation protection 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 main tained, developed and 
continuously improved. However, binding Community legislation in the area of nuclear safety 
has not been adopted until present.  
At present, the interest in nuclear energy is  undergoing a revival phase, due to a number of 
driving factors.  
Energy efficiency, renewables a nd sustainable biofuels all have  a very important and growing 
contribution to a sustainable energy policy. However, for the production of ba se-load energy 
at competitive prices, nuclear energy is cu rrently the main low-carbon source in many EU 
Member States. 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. Nuclea r energy provides more than a th ird 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. Con tinued use of nuclear energy therefore would 
increase the EU energy independence and secur ity of supply as well  as contribute to the 
limitation of CO
2 emissions, but it is also still confronted with a num ber of outstanding issues 
that need to be resolved. Provi ded an adequate level of safety  is ensured, nuclear energy can 
                                                 
10 OJ No C 185 of 14 August 1975, p. 1. 
11 OJ No C 172 of 18 June 1992, p. 2. 
 
EN 10   EN continue to play an important role in the EU, supported by a firm  commitment in research and 
promotion of technological developments, aimed at further enhancing its safety. 
Safety infrastructure includes many compon ents, including the legal framework and 
regulatory capability, emergency preparedness and response,  educated and trained manpower, 
a stable electrical grid, ade quate financial and industrial re sources, and the nurturing of an 
appropriate safety culture in the generating ent ity. Therefore, there are many responsibilities 
that arise from the commitment to using nuclear energy and the new and expanding 
programmes must take appropriate and timely ac tions to fulfil those responsibilities. The 
Member States must remain mindful of the fact that the prime responsibility for safety always 
rests with the operator and that an appropriate  safety infrastructure, independent of any 
contractual arrangements is neces sary. All these aspects are for th e time being regulated at the 
level of Member States, which crea tes a too heterogeneous situation. 
Replacement and/or life extension of ageing nu clear power plants (NPPs) deserve special 
attention, since a large number of currently opera ting plants in the EU will come to the end of 
their originally foreseen lifetime before 2030, leading to a substan tial decrease in the 
contribution of nuclear energy, unless new plants are built or older ones  are upgraded, so that 
they can safely operate for an extended period. Also, a high level of nuclear safety in the EU 
requires ensuring the safe closure and decommi ssioning of those nuclear reactors reaching the 
end of their lifetime, or for wh ich safety cannot be upgraded at an appropriate high level in an 
economical manner. According to recent forecasts12, as a result of political decisions on 
nuclear phase-out in certain old Member-States a nd the closure of plants with safety concerns 
in some new Member-States, nuclear energy outpu t will be 20% smaller in 2030 than it was in 
2005. As a consequence, in order to maintain th e share of nuclear energy in the energy mix, 
new investments are expected to  replace or upgrade aging ge neration capacities. In the EU, 
currently two new nuclear installations are under construction (1 in Finland and 1 in France). 
Several others are planned or  firmly decided in some Me mber States (e.g. Mochovce 
(Slovakia), Belene (Bulgaria), Cernavoda (Romania), Ignalina (Lithuania), as  well as an 
indefinite number of installati ons especially in France and the UK). In addition, other types of 
installations are under co nstruction (e.g. enrichment plants). The absence of an EU framework 
establishing fundamental safety  principles and requirements creates uncertainties for the 
investors. Therefore, in the current context it is the right time to reconsider the project of 
setting up a Community nuclear safety approach that would create a legal reference and a 
level playing field throughout the EU, as currently  there is a different system in each Member 
State, leading to a certain degree of fragmentation. 
Moreover, this exercise would also reflect externally, by ensuring the existence of a 
comparable basis for discussions in the proce ss of negotiation of nuclear-related International 
Agreements between the Community and third parties. 
Another aspect that has to be highlighted is that, even if fo llowing the Chernobyl accident, no 
major accidents have occurred within the EU or in its neighbourhood, nevertheless several incidents on a low INES scale of 0-2 have been  reported. This sporadic recurrence of events 
of concern make clear that the promotion of a strong safety culture at EU level — for both 
operators and regulators — supported by appropri ate legal instruments, should represent a 
priority. 
                                                
 
12 European Energy and Transport - Trends to 2030 Update 2007  
(http://ec.europa.eu/dgs/energy_transport/figures/trends_2030_update_2007/energy_transport_trends_2
030_update_2007_en.pdf ) 
 
EN 11   EN The nuclear sector is also confronted with the problem of the ageing of qualified human 
resources dealing with technical matters. Efforts are needed to establish an effective process 
for the development and transfer of knowledge  areas and to ensure the preservation and 
availability of resources.  
Finally, public acceptance should be considered, as it is one of the driving factors of the future 
development of nuclear energy. Th e existence of different nati onal regulatory systems will 
only perpetuate the current lack of information in the field, illustrated by the results of the opinion polls carried on by the Commission with the participat ion of respondents from the 
Member States. Information on the measures a dopted by the Member States on nuclear safety 
matters should be openly made available to th e public in a timely and accurate manner. 
2.2. Underlying drivers of the problem 
Following the Chernobyl accident in 1986 - undoubted ly the most serious accident in the 
history of atomic energy, and the G-7 Summit in Munich in 1992, the EU began to concern 
itself with the safety of nuclear installations in the Central and East ern European countries 
and the Republics of the former Soviet Union. 
Nuclear safety is still a centra l issue in the context of the r ecent enlargements of the EU. The 
work carried out in the Community framework in  order to bring nuclear installations in the 
former candidate countries up to  a high level of safety allowe d a European perspective to 
emerge in this context.  
Four first generation Soviet-design nuclear reactors (Ignalina 1 and 2 in Lithuania and 
Bohunice 1 and 2 in Slovakia) are being shut down in predetermined stages in compliance 
with the 2004 Accession Treaty. The EU is providi ng financial assistance, subject to certain 
conditions, to various projects on decommissioni ng and replacement of electricity generation 
capacity. Similar arrangements are in place for four of the six reactor s at Kozloduy, two of 
which were already closed prior to Bulgaria 's accession to the EU and another two were 
closed by the end of 2006 as part of Bu lgaria's EU Accession Treaty. Two Regulations
13 were 
adopted, providing for continued financial a ssistance to Lithuania and Slovakia until 2013, 
guaranteeing at least the same  level of funding as agreed  for the period 2004-2006. Euratom 
loans have been provided to Kozloduy 5 and 6 in Bulgaria (€212.5 million in 2000 to improve 
safety-related equipment), Cernavoda 2 in Romania (€223.5 million in 2004 for construction). 
Also, the extension of plant lifetime where safe ly possible and/or new construction aiming at 
meeting the electricity demand, is necessary in order to maintain the share of nuclear energy 
in the current energy mix.  
Evidence of widely differing safety and secur ity measures were observed by the Commission 
when giving its point of view on the built  of new plants proposed since 2004. Such 
differences not only impact on the overall safe ty of the workers and the population, but may 
entail cost differences for the cons truction and operation of the plants. 
Protection from ionising radi ation is also a concern after the end of the active life of a nuclear 
installation. In practice, final shutdown of a nuclear installati on marks the start of a new phase 
with the objective of lifting the radiological pr otection restrictions imposed while it was in 
operation. These restrictions are due to the presence of large quant ities of radioactive 
materials in the form of structural materials, equipment, operational waste and spent fuel. It is 
therefore necessary to re move these materials and to subject them to the treatment appropriate 
                                                 
13 Council Regulation (EC) No 1990/2006 (OJ L 411, 30.12.2006, p. 10–17)  
Council Regulation (Euratom) No 549/2007 (OJ L 131, 23.5.2007, p. 1–4) 
 
EN 12   EN to their physical characteristics and their levels  of radioactivity, in accordance with safety 
standards in force. 
Also, the climate change issue has revamped the public debate on nuclear power. Public 
opinion constantly requires the hi ghest possible level of nuclear safety and information on it, 
because of the keen public awareness of the risks for human health and the environment, 
linked to the operation of NPPs. Concerns about the safety of NPPs, management of 
radioactive waste, security, pr oliferation and terrorism have all had an influence on public 
opinion. 
2.3. Who is affected, in what ways, and to what extent? 
Euratom legislation in force does not address th e particular aspects of nuclear installation 
safety. The primary responsibility for the safety of nuclear installations rests with the holders 
of the relevant licence, under th e control of the national regula tory authority of each Member 
State.  
Along the lines of the existing national systems, it is necessary to consider nuclear safety in a 
Community perspective. Enshrining in Co mmunity legislation the obligations and 
requirements of the Convention on Nuclear Safety  and the principles laid down in the IAEA 
Safety Fundamentals will make it possible to reconcile efficiency and speed of 
implementation. Interlinking the national system s and the Community system will guarantee 
the maintenance of a high level of safety for nuclear installations in the enlarged 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 decision-making pr ocess applied at EU 
level on nuclear safety matters.  
The nuclear safety Directive will benefit EU citizens by enhancing their safety and giving 
them legal certainty. It would al so benefit Member States, as it would give them a reference 
for their national nuclear safety systems. It w ould benefit the national nuclear safety control 
bodies as it would ensure that they get enough m eans for their work and give them the driving 
role in implementing the common EU rules. 
Also, the establishment of a common approach in  the field of nuclear safety will lead to the 
increase of the nuclear energy's competitiveness. 
2.4. The evolution of the prob lem all things being equal 
At present, EU is facing major challenges linked with climate change, increasing import 
dependence and higher energy pri ces, in the overall context of a growing interdependence of 
EU Member States in energy aspects.  
Under the New Energy Policy projections
14, total EU-27 energy requirements continue to 
increase slightly (1.5%) by 2020 in case of moderate oil prices and to decrease slightly (-2%) 
in case of high oil prices15. Under these projections, only rene wable energy sources increase 
their market share. The share of nuclear in total energy consumption drops slightly, from 14% 
in 2005 to between 12 and 14 % by 2020. In tota l the share of indigenous and low carbon 
energy sources rises from 21% in 2005 to 30% in 2020. 
                                                 
14 The figures under this section have been updated in line with the Commission's Second Strategic 
Energy Review adopted on the 13 November 2008. Fi gures presented elsewhere in the graphs are based 
on the Nuclear Illustrative Programme adopted in 2007. 
15 Commission staff working document: Europe's current and future energy position, Demand – resources 
– investments, COM(2008) 744 
 
EN 13   EN Import dependence continues to grow even und er the New Energy Policy projections, from 
around 52% in 2005 to between 56 and 58% in 2020. Import dependence fo r oil continues to 
be the highest, reaching 92% in 2020. Gas import  dependence rises substantially, from 58% at 
present to between 71 and 73% in 2020. Simila rly, solid fuel supply will be increasingly 
based on imports, reaching around 50% in 2 020 (up from just under 40% today). EU-27 
energy related CO2 emissions are expected to remain below the 1990 level and to decline another 18 to 20% by 2020 under th e New Energy Policy scenario. 
 
Currently, NPPs generate approximately one thir d of the electricity and 14% of the energy 
consumed in the EU. Nuclear power is curren tly the largest source of low-carbon dioxide 
(CO2) production of energy in the EU. Also, it is less vulner able to fuel price changes than 
coal or gas-fired generation, as  uranium represents a limited part of the total cost of 
generating nuclear electricity and is based on sources which are sufficient for many decades 
and widely distributed around th e globe, being as well one of the cheapest sources of low 
carbon energy that is presen tly produced in the EU. 
To meet the expected energy demand and to  reduce European dependency on imports, 
decisions are expected to be made on new invest ments or on the life extension of some plants. 
Having in view the fact that a significant numbe r of NPPs are due to close down within the 
next 20 years, construction of new plants and/or extension of the current operating lifetimes of 
existing reactors will be required if the Member States choose to keep the low CO2 option and maintain or even increase the current shar e of nuclear power in the overall energy mix.  
While each Member State and energy utility chooses its own energy mix, individual national 
decisions relating to nuclear energy can have more  general impacts in terms of the electricity 
market, the EU's overall dependence on im ported fossil fuels, CO2 emissions, and 
competitiveness, but also in terms of the envi ronment and safety. In particular, a serious 
incident at a NPP could affect neighbourin g Member States. Cross-border impacts are 
possible also in managing the back-end of the fu el cycle (radioactive waste, including from 
decommissioning). In addition, it should be menti oned that some companies intend to invest 
in the EU in the construction of NPPs in different Member States. 
Experience of managing industrial risks has already shown the possible trans-boundary 
environmental consequences. There are already similar provisions foreseen in the Euratom 
Treaty in Article 37 in the fi eld of radioprotection, that provide the obligation of each 
Member State to notify to the Commission any plan s for the disposal of radioactive waste that 
would result in the radioactive contamination of the water, soil or airspace of another Member 
State. 
Therefore, at present it is no longer possible to consider nucl ear safety from a purely national 
perspective. Only a common approach can gua rantee the continuous im provement of nuclear 
safety in an enlarged Union of 27-Member States. 
2.5. Community competence 
2.5.1. Euratom Treaty legal basis 
Civil nuclear activities are regulated in the European Union by the Euratom Treaty, signed in 
1957. The Euratom Treaty contains provisions allo wing the Community to regulate the use of 
nuclear energy by the Member States, in particul ar those governing health  protection (Chapter 
3) and nuclear safeguards (Chapter 7).  
The competence of the European Atomic Energy Community to regulate in the field of the 
health protection against ionizing radiation is  explicitly recognised by the Euratom Treaty. 
Accordingly, in the Treaty's Preamble, th e Member States declare that they are "resolved to 
 
EN 14   EN create the conditions necessa ry for the development of a strong nuclear industry"  and also  
"anxious to create conditions of safety necessa ry to eliminate hazards to the life and health of 
the public". In addition, pursuant to Article 2(b) of the Treaty, the Community is mandated to 
"establish uniform safety standards to protect th e health of workers and of the general public 
and ensure that they are applied." Title II, Chapter 3 "Health and Safety", sets up a number of 
detailed provisions intended to establish, give  effect and apply the basic safety standards 
mentioned in Article 2(b) of the Euratom Treaty. Article 30 paragraph 1 of the Euratom 
Treaty establishes that " Basic standards shall be laid down within the Community for the 
protection of the health of workers and the general public against the dangers arising from 
ionizing radiations ." Article 32 provides that the basic standard s may be revised or 
supplemented. A substantial corpus of Euratom le gislation in the field has been adopted and 
updated during the years and is completed by a set of legal instruments of different binding 
nature, covering a wide range of aspects such as operational protection of workers (including 
outside workers) and population, natural radioactive sources, high activity sealed sources and 
orphan sources, emergency preparedness, medical  applications, contro l and supervision of 
shipments of spent fuel and radioactive waste, as  well as a number of regulations establishing 
provisions on the conditions governing imports of  agricultural products originating in third 
countries following the accident at the Chernobyl NPP, aimed at safeguarding the health of 
consumers of such products. The central element of this legislation is the Council Directive 
96/29/Euratom laying down basic safety standard s for the health protection of the general 
public and workers against the dangers of i onising radiation (Basic  Safety Standards 
Directive)16. 
Chapter 3 of the Euratom Treaty has been us ed so far mainly for radiation protection 
purposes. It is, however, undeniable that health  protection covers both  radiation protection 
and nuclear safety, two closely linked concepts serving a common health protection objective.  
This approach has been confirmed by the jurispr udence of the European Court of Justice. In 
its judgement from 10 December 2002 in the Case C-29/99, the Court stated17 that “ it is not 
appropriate, in order to defi ne the Community’s competen cies, 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 confirms on the other hand the technical competence of 
national safety authorities to authorise the co nstruction or operation of  nuclear facilities. 
However, the Court recognises that this technical competence do es not prevent the 
Community from legislating in  this field. The Court judgeme nt is on this point explicit18: 
“Even though the Euratom Treaty does not grant  the Community competence to authorise the 
construction or operation of nuclear installa tions, under Articles 30 to 32 of the Euratom 
Treaty the Community possesses legislative compet ence to establish, for the purpose of health 
protection, an authorisation system which must  be applied by the Member States. Such a 
legislative act constitutes a measure supplemen ting the basic standards referred to in that 
article .”  
In the conclusions of the Advocate-General Jacobs delivered on 13 December 2001 in the 
Case C-29/99 it is concluded  that "In the light of the current scie ntific knowledge, it is neither 
possible nor desirable to maintain artificia l boundaries between radi ation protection and 
nuclear safety. From a legal perspective it is also evident that mode rn radiation protection 
systems such as the Basic Standards Directive are increasingly source-oriented and therefore 
                                                 
16 OJ L 159, 29.6.1996. 
17 Commission of the European Communities v Council of the European Union (Case C-29/99)- 
paragraph 82 
18 paragraph 89 
 
EN 15   EN necessarily also regulate aspects of the safety of installations."19 Furthermore, the Advocate-
General states that "The fact that the Member States retain exclusive competence over the 
technological aspects of nuclear safety does not prevent the Community from adopting 
legislation which establishes certain safety  requirements, authorisation requirements, 
inspection and assessment requireme nts or enforcement mechanisms."20 
2.5.2. Competence recognised by the Council of the European Union 
With the development of the European nucl ear 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 
safety recognised that it was th e Commission's responsibility to ac t as a catalyst in initiatives 
taken at international level in the field of nuclear safety. This Resolution, while "taking into 
account the prerogatives and responsibil ities assumed by national authorities" , makes 
reference to the alignment of safety requireme nts in the context of a desirable harmonised 
approach at Community level. It  calls for effective collabora tion among Member States at EC 
level and specifically requires the "progressive harmonization of safety requirements and 
criteria in order to provide an equivalent and satisfactory degree of protection of the 
population and of the environment against the ri sks of radiation resulting from nuclear 
activities and at the same time to assist the development on trade on the understanding that 
such harmonization should not involve any lowering of the safety level already attained" . As a 
result of this Resolution, the Commission set up several expert group s dealing with nuclear 
safety matters.  
Against this background, a s econd Council Resolution was adopted in 1992. In this 
Resolution, the Council reaffirm ed the intentions of the 1975 Resolution and invited Member 
States to continue and intensif y concerted efforts towards harm onization of safety issues. In 
this context, the Council "requests the Member States to  continue - with an active 
contribution from the Commission - to ensure gr eater concerted effort between the national 
safety authorities in the Community on sa fety criteria and requirements and on the 
incorporation of the conclusions reached into the practice followed in the Member States, in 
order to arrive at a system of safety crit eria and requirements recognized throughout the 
Community ." and "encourages the Member States and the Commission to act in a coordinated 
manner in international fora on the basis of the achievements reached in the Community 
towards a system of internationally accepted nu clear safety criteria and requirements, in 
particular in the framework of the Inte rnational Atomic Energy Agency (IAEA)."  The 
European Council has regular ly recalled the 1992 Resolution in the context of the 
enlargement process and the importance of deve loping high standards of nuclear safety in 
Central and Eastern Europe. Following this Reso lution, participation in the expert groups was 
extended to representatives of the Central and Eastern Europ ean Countries and the Republics 
of the former Soviet Union (NIS). 
In the framework of the discussions on Commission proposals for Council Directives 
(Euratom) setting out the basic obligations and general principles on the safety of nuclear 
installations and on the management  of spent nuclear fuel and ra dioactive waste, in the June 
2004 Council Conclusions on nuclear safety and on the safety of the management of spent nuclear fuel and radioactive waste
21, the following statements were made: 
“(the Council) urges Member States  together with the Commission: 
                                                 
19 paragraph 166 
20 paragraph 167 
21 10823/04 
 
EN 16   EN to avail themselves in particul ar of the possibilities offered by  the review meetings under the 
Convention on Nuclear Safety and the Joint Convention on the Safety of Spent Fuel 
Management and on the Safety of Radi oactive Waste Management in 2005 and 2006 
respectively, 
to assess the results achieved under these Conventions, including at previous Conferences of 
the Parties,  
to take stock of the outcome of the work c onducted by national nuclear regulatory authorities 
in multinational fora, including in the WENRA framework,  
and on that basis to engage in a wide ranging consultation process facilitating the choice of instrument(s), in 
the framework of the Euratom Treaty, that c an contribute more eff ectively to achieving 
nuclear safety and the safe management of spent fuel and radioac tive waste, without 
excluding any instrument and in line with the principles of better law making.” 
The importance of an EU action in  the field of nuclear safety is also emphasised in the May 
2007 Council Conclusions on Nuclear Safety and Sa fe management of spent nuclear fuel and 
radioactive waste
22. In the Preamble of the Conclusions, it is stated that "Bearing in mind that 
nuclear safety is a national re sponsibility exercised where a ppropriate in an EU-framework. 
Decisions concerning safety actions and the superv ision of nuclear instal lations remain solely 
with the operators and national authorities."   
2.5.3. Competence recognised by the European Council 
The Cologne European  Council in June 199923 asked the Commission to  ensure that high 
nuclear safety standards are a pplied in Central and Eastern Europe. Following on from this 
request, the safety of nuclear installations in  the candidate countries was evaluated by the 
Commission and the Council in 2001, making it possi ble to arrive at a European perspective 
on nuclear safety, agreed by the fifteen  Member States and the Commission. 
The Laeken European Council in December 2001 marked the transition from reflection 
conducted in the perspective of en largement to that of a global political vision at the level of 
the enlarged EU. One of the conclusions24 of this meeting was that "the European Council 
undertakes to maintain a high level of nuclear sa fety in the Union. It stresses the need to 
monitor the security and safety of nuclear power  stations. It calls for regular reports from 
Member States' atomic energy experts, w ho will maintain close contacts with the 
Commission". The Conclusions of the Laeken Council apply the Cologne Conclusions within 
the EU, the objective of both sets of conclusion s being to maintain a high level of nuclear 
safety.  
In the Presidency Conclusions25 of the Brussels European Council from March 2007, it is 
stated that the European Council "confirms that it is for each  and every Member State to 
decide whether or not to rely on nuclear energy  and stresses that this has to be done while 
further improving nuclear safety  and the management of radioacti ve waste, and to that effect 
it…can envisage the creation of a high-level gr oup on nuclear safety and waste management."  
                                                 
22 Adopted at the 2798th meeting of the Council of the European Union (Economic and Financial Affairs) 
- 8784/07 
23 150/99 REV 1 
24 SN 300/1/01 REV 1 
25 7224/1/07 REV 1 
 
EN 17   EN 2.5.4. Competence underlined by the European Parliament Reports  
The Committee on Industry, External Trade, Rese arch and Energy of the European Parliament 
published in 2002 a report on the Commission Communication on the Operation of the 
Euratom Safeguards Office in 1999-2000, with Paul Rübig as a rapporteur26. In this report, the 
European Parliament encourages the Commission " to propose a Directive to fix a reference 
framework for all activities of auditing and certification in the field of Nuclear Safety, 
Security and Safeguard ". 
In the 2007 Report on Assessing  Euratom – 50 Years of European nuclear energy policy27, 
published by the Committee on Industry, Research  and Energy, with Eugenijus Maldeikis as a 
rapporteur, one of the gaps identified by the European Parliament was exactly "the absence of 
a legislative corpus on harmonised standards with real added value, particularly in 
comparison with the exis ting international framework, for nuclear safety, the management of 
radioactive waste and the decommi ssioning of nuclear plants" . In this context, the Report 
reiterates the Commission's co mpetence to regulate in the area of nuclear safety under 
Euratom Treaty, as confirmed by the judgment of  the Court of Justice in the Case C-29/99. 
Furthermore, it is pointed out that "in the context of a need to adapt European energy policy 
and extend the working lives of power stations, th ere is an urgent need to draw up robust 
legislation and adopt concrete measures at Commun ity level in the fields of nuclear safety, the 
management of radioactive waste and th e decommissioning of nuclear plants".  For that 
matter, the Parliament " invites the Commission to review the re levant drafts of  its legislative 
proposal and submit new proposals for directives on the safety of nuclear facilities, on waste 
management, and on closure and decommissioning of nuclear facili ties taking into account 
the ‘polluter-pays’ principle ". It also "urges the Commission and Counc il to look into this 
question with all due speed"  and asks to be consulted in this work. 
A similar position is reflected in the Report on Conventional energy sources and energy 
technology28, published by the Committee on Industry, Research and Energy, having Herbert 
Reul as rapporteur, which "welcomes the Commission's call for the imposition in the EU of 
common reference levels for nuclear safety; in that connection, urges th at, on the basis of a 
best practice peer review, these reference le vels should reflect the highest possible safety 
standards" . Moreover, the report "recalls that dozens of nucle ar power plants are planned or 
being built worldwide, and that it is vital for th e EU to be involved in their construction, both 
from the point of view of industrial strategy  and in order to promote the most stringent 
possible safety principles throughout the world" . This approach is in line with the Nuclear 
Illustrative Programme29, adopted in accordance with Artic le 40 from the Euratom Treaty. 
2.5.5. Initial Nuclear Safety Package 
On 30 January 2003, after receiving in Decem ber 2002 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 waste30. The legal bases of these tw o proposals are included in 
Chapter 3 of Title II of the Eu ratom Treaty, which c oncerns health protect ion. The initial draft 
Directive setting out basic obligations and ge neral principles on the safety of nuclear 
installations proposed common sa fety standards and verification mechanisms to guarantee the 
                                                 
26 A5-0196/2002 
27 A6-0129/2007 
28 A6-0348/2007 
29 COM(2007) 565 final 
30 COM 2003/32 final  
 
EN 18   EN application of common methods and criteria with regard to nuclear safety throughout the 
enlarged EU.  
After the European Economic and Social Co mmittee gave its opinion on 26 March 2003, both 
proposals were forwarded to the Council. In acco rdance with the procedure in Article 31 of 
the Euratom Treaty, the Council requested the opi nion of the European Parliament. Debates 
took place within the ITRE subcommittee. The European Parliament adopted opinions on the 
proposals in its plenary session on 13 January 2004. The opinion of the European Parliament 
supports the approach taken by the Commission of endowing the enlarged EU with binding 
legislation in the field of safe ty of nuclear facilities and of  radioactive waste management. 
Parliament adopted a number of amendments, the majority of which were acceptable to the 
Commission. Subsequen tly, revised proposals31 were elaborated taking into account certain 
amendments brought by the European Parliament , but also the develo pments of the texts 
following the discussions within the Council. Th e main request of the European Parliament 
concerned the financing of the decommissi oning of nuclear facilit ies. The European 
Parliament pointed out that there existed am ong Member States a diversity of methods to 
finance decommissioning operations which could lead to distortions of competition and to 
discriminations between the producers of nucl ear power. The Commissi on had stressed during 
the debates in the European Parliament the impor tance of this question in the context of the 
internal market of electric ity. In October 2006 the Commissi on adopted a recommendation on 
the use of decommissioning funds32 which is the basis of annua l reports to the European 
Parliament on the subject. 
At the same time, both proposal s were discussed in the Counc il, under the Italian and Irish 
Presidencies. One of the problems encountered by  delegations was the absence of clear safety 
standards to be used in conjunction with the directive. This obstacle is removed since 2006, 
when WENRA finalized the publication of safe ty reference levels for existing nuclear 
reactors, which can be used by the Member States  as a reference. An additional major concern 
expressed by the Council was the intention of  the Commission to cr eate a body of safety 
inspectors, removing such competence from the national regulators. The budgetary provisions 
in the safety directive were designed for such purpose. It should be remarked that the current approach reverses this point completely, leaving the nuclear safety inspections solely to the national regulators. The Atomic Questions Grou p (AQG) referred the matter to the Permanent 
Representatives Committee in November 2003 and May 2004. As a ma jority allowing the 
adoption or the rejection of both proposals for Di rectives was not possible to be obtained at 
the Coreper II meeting of 13 May 2004, it was agreed that Council conclusions would be worked out by consensus.  
Draft conclusions on nuclear safety and on the safe ty of the management of spent nuclear fuel 
and radioactive waste were agreed by Member  States within the AQG and were adopted by 
the Council on 28 June 2004
33. Subsequently, as a consequence of the June 2004 Council 
Conclusions, the WPNS  was activated.  
In addition, in 2007, the Commission launched two initiatives to fu rther debate the future of 
nuclear energy and to identify requirements for its  development. The first is the HLG focusing 
on identifying safety issues for priority hand ling and recommending actions  to be taken at EU 
                                                 
31 COM(2004) 526 final 
32 Commission Recommendation of 24 October 2006 on the management of financial resources for the 
decommissioning of nuclear insta llations, spent fuel and radioactive waste, OJ L330, 28.11.2006. 
33 10823/04 
 
EN 19   EN level. The second, the European Nuclear Energy Forum, intends to provide a platform for a 
broad and transparent stakeholder discussion on the opportunities and ri sks of nuclear energy. 
2.6. Subsidiarity  
The EU Member States have already implemen ted measures enabling them to achieve a high 
level of nuclear safety within the EU. Howe ver, because of the different historical 
backgrounds, legal frameworks, type and number of reactors and differe nt approaches to 
regulation, common rules in the field of nuclear  safety to be applied across the Community 
have not yet been established, although this wo uld lead to a further improvement of nuclear 
safety, which could not be achieved exclusively at national level.  
The Community's competence to set up basic safe ty standards at EU level is explicitly 
regulated in the Euratom Treaty. Accordi ng 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 Eu ropean 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-29/99, the Court stated that “ it is not 
appropriate, in order to defi ne the Community’s competen cies, 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 the protecti on of the health of workers a nd the general public against the 
dangers arising from ionizing radi ations have to be complemented with safety standards for 
nuclear installations, as well as that the techni cal competence of the national authorities with 
responsibility for safety does not preclude the Community from legislating in this connection. 
After the Chernobyl accident in  1986, the problem of ensuring nuclear safety worldwide was 
addressed with new vigour, especially within  the IAEA, under whose auspices the Convention 
on Nuclear Safety has been enacted. However, this Convention is a voluntary mechanism that does no allow to verify the Contracting Parties' compliance with its rules. In the current context of the expansion of the global dema nd for nuclear generatio n which has a trans-
national impact, enacting Community legislati on recognising internati onally endorsed nuclear 
safety principles and aiming to achieve and mainta in a high level of nuclear  safety at EU level 
becomes a prerequisite of the future developm ent of nuclear energy. Over the years, the 
support for the elaboration of EU nuclear safety legislation has been constantly reflected by 
the Council and the European Parliament, and mo re recently by the European Nuclear Energy 
Forum. A revised proposal would also respond to the expectati ons of citizens that consider 
nuclear safety an essential matter to be handled at EU level, as demonstrated by the 2007 Eurobarometer. Despite this support and desp ite a previous proposal  in the area, no EU 
nuclear safety legislatio n is in force today.  
The new proposal reverses the top-down appr oach of the 2003/2004 proposal to a bottom-up 
one and encourages Member States' cooperati on, as for the safety of new nuclear power 
reactors, Member States are encouraged to de velop 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, Memb er States retain the right 
to impose at national level more stringent safety measures than those provided for in the Community legal framework. 
 
EN 20   EN Secondly, at the level of prin ciples proposed, the revised Di rective is anchored on the 
competence existing in the Member States' re gulatory authorities, as well as on the 
internationally endorsed princi ples of the Convention on Nucl ear Safety and of the IAEA 
Safety Fundamentals, thus not imposing a ny additional burden on the Member States' 
authorities. All the EU Member States and Eura tom are Contracting Parties to the Convention 
on Nuclear Safety. The IAEA safety standard s, comprising Safety Fundamentals, Safety 
Requirements and Safety Guides, are binding on the IAEA for its own operations, are applied 
by other sponsoring organizations for their ow n operations, and are recommended for use by 
States and national authorities in relation to their own activities.  
EU binding legislation also prov ides legal certainty by opening th e possibility for citizens to 
turn to the European institutions in case they  feel unsafe about the sa fety of nuclear energy. 
Moreover, it should be mentioned that the new proposal takes fully into account the Member 
States' views expressed during the examina tion 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 leav ing the responsibility of nuclear safety 
inspections solely to the national regulators. 
SECTION 3: OBJECTIVES  
3.1. General objective 
The general objective of the proposed Directive is to achieve, maintain and continuously 
improve nuclear safety and its regulation in th e Community and to add value by enhancing the 
role of the regulatory bodies. This  would lead to the increase of  the safety of the operation of 
NPPs, the  sustainable contribution of nuclear ener gy to the EU's growing energy demands, 
ensuring a level playing field for new investme nt in NPPs, tackling the trans-boundary effects 
of eventual nuclear incident s by creating the premises of a unitary and coordinated EU 
response, increasing the level of public acceptance of nuclear energy.  
Its scope of applicatio n is the design, siting , construction, maintenance, operation and 
decommissioning of nuclear insta llations, for which consideration of safety is required under 
the legislative and regulatory framework of  the Member State concerned. Nuclear 
installations cover nuclear  fuel fabrication plants, research reactors (including sub-critical and 
critical assemblies), nuclear power  plants, spent fuel storage fac ilities, enrichment plants or 
reprocessing facilities. 
In this context, it should be clarified that the transport of radioactive material falls outside the 
scope of the revised Directive on nuclear safety. The recast  of the Community regulatory 
framework on the transport of radioactive mate rial is a separate it em on the Commission 
legislative agenda. 
3.2. Operational objectives/ principles 
Through creating a Community framework for Nuclear Safety the following operational 
objectives should be achieved: 
– Enhancing the role of  national regulators; 
– Prime responsibility of the licence holder for safety under th e control of the regulatory 
body;  
– Reinforcing the independen ce of the regulatory body; 
– Ensuring a high level of transparency on issues re lated to the safety of nuclear installations;  
– Implementation of management systems; 
 
EN 21   EN – Regular safety supervision;  
– Availability of nuclear  safety expertise; 
– Priority to safety. 
3.3. The consistency of these objectives with other EU policies  
The development of a Community approach in  the field of nuclear  safety, supported and 
complemented by national legislation, will have as  a result the achievement of an increased 
level of protection of the health of workers and public, as well as of the environment, against 
radiation hazards. Therefore, it would contribute to the full achie vement of the objectives of 
the Basic Safety Standards Directive, as well as of all the legislation in the area of radiation 
protection, namely protecting the workers and the general public against the dangers of 
ionising radiation without unduly limiting the benefi cial uses of the practices giving rise to 
radiation exposure. 
SECTION 4: POLICY OPTIONS  
Policy option 0  assumes that no additional rules in the field of nuclear safety are established 
at Community level, in order to harmonise the existing approaches. Option 0 would leave 
things as they are. This is the business-as-usual scenario. 
Policy option 1  assumes the elaboration of Community legislation that has the objective of 
establishing common safety standa rds for existing nuclear installa tions. This was the approach 
envisaged in the process of elaboration an d negotiation of the Co mmission proposal for 
Council (Euratom) Directive setting out basic oblig ations and general principles on the safety 
of nuclear installations. 
Policy option 2 assumes the elaboration of Community  legislation that sets up only a 
common framework aiming at achieving and main taining a high uniform level of nuclear 
safety throughout the Community, by recalling widely recognised principles analysed and 
confirmed at international level. The implem enting guidelines and arrangements will be 
prepared at the level of the HLG that comprise s high – level representatives of the regulatory 
and safety authorities from the EU Member States.  
Policy option 3  is built upon a set of in ternationally-recognised nu clear safety principles 
(approach proposed by Policy option 2), supplemen ted 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 collabo ration with the HLG.  
 
EN 22   EN A presentation of the envisaged sharing of competencies between the EU, Member States and 
the HLG under this policy option is included in the table below.  
EU Member States HLG 
– Setting basic nuclear safety 
principles in the Directive; 
– HLG secretariat; 
– Supervising the implementation 
of the Directive, including non 
compliance cases. – Transposing the Directive in 
national law; 
– Fulfilling the obligations and 
requirements set up in the 
nuclear safety EU legislation 
(e.g. establishing and maintaining a legislative and 
regulatory system, ensuring the 
independence of the regulatory body, informing the public on 
the issues related to nuclear 
safety, respecting the principles of the IAEA Safety 
Fundamentals and the 
obligations and principles of the Convention on Nuclear Safety, 
developing, if considered 
appropriate, additional safety 
requirements);  
– Sending HLG delegates; 
– Cooperating with the HLG in 
the process of defining 
additional safety requirements; 
– Collaborating within WENRA. – Focal point for the cooperation 
of the national regulators; 
– Cooperate with  the Member 
States in the process of defining 
additional safety requirements; 
– Upon the adoption of a EU 
Directive on nuclear safety, the 
initial mandate of the HLG will 
be revised in line with the new legal framework.
 
 
SECTION 5: ANALYSIS OF IMPACTS  
5.1. Policy option 0  – no policy change.  
a) Safety-related impact   
At the end of 2007, in EU-27 a total of 146 nuclear reactors ar e in operation in 15 Member 
States, totalling a capacity of 132 GWe. The averag e age of NPPs is approaching 25 years. In 
France, which has the largest fleet (59) of nuc lear reactors accounting for nearly 80% of its 
electricity generation, and Lithuania, with only one NPP yet accounting for 70%, the average 
age is around 20 years. The UK fleet of 19 NPPs  has an average age approaching 30 years, 
while in Germany the average age of their fleet  of 17 operational NPPs is nearly 27 years34. 
Also, within the EU, some Member States have  decided or planned to construct new nuclear 
reactors. For those EU countries that choose to  continue or to start making use of nuclear 
energy generation, Member States' Governments need  to take the necessary decisions. In the 
current context, as nuclear safety is paramount in Member States' decision on whether to continue to use nuclear energy, being al so the foundation upon which a nuclear power 
programme must be built upon, a Community nuclear safety approach represents an essential 
element for developing a sustainable safety infr astructure at the nation al level. It requires 
common or shared approaches, bu ilt on solid national and intern ational experience. The lack 
of such a common framework will have negativ e effects for the sustainability of nuclear 
energy at EU level. 
                                                
 
34 source: update of COM (2007) 565 final data 
 
EN 23   EN The distribution of operational an d planned shutdown for NPPs in the enlarged EU as well as 
potential new build, and the distribution of age of  NPPs in the EU are presented in the figures 
below, as adopted by the Commission in October 2007. 
Figure 6 : EU 27 Operational & Shutdown NPPs by age
04812162024
0 5 10 15 20 25 30 35 40 45
Age (at 1/11/06 or at SD)Nr152 operational NPP 
(-3 from 31/12/06)
operational and to shutdown before2025 in a 40y lifetime scenario
2 Under Construction (FI, RO)
67 actually Shutdown NPP (+3 from 31/12/06)
Source TREN, PRIS 
source: COM(2007) 565 final 
Figure 7 : Age (on 01/04/06) of NPPs in the EU
051015202530354045
RO (1)
BG (4)
CZ (6)
SK (6)
LT (1)
HU (4)
SI (1)
EU-10 (23)
EU-15 (129)
FR (59)
SP (8)
GE (17)
BE (7)
FI (4)
SE (10)
UK(23)
NL (1)
EU-25 (148)
EU-27 (152)Source PRISyOldest
Mean Age
Youngest
<———— —NPP in EU-15 ———— > <————NPP in EU10+2———— > more recent 
Plantsin NEW MS
 
source: doc. COM(2007) 565 final 
b) Competitiveness impact 
Since legislation on the liberalis ation of the energy market ha s been enacted, the role of 
governments has evolved towards creating the appropriate framework for competition. On 
liberalised markets, investment decisions ar e taken by investors and not by governments.  
 
EN 24   EN Cost and investment risks are important issues when consid ering construction of nuclear 
reactors. Nowadays a new NPP involves an invest ment in the range of € 2 to 3.5 billion (for 
1000 MWe to 1600 MWe respectively)35. It is essential that  plans for both new and 
reinvigorated nuclear power development and other uses of nuclear technology are 
complemented with equally ambitious plans for the establishment and enhancement of 
sustainable safety infrastructures.  
Investments in new nuclear facili ties require a stable legislativ e and political framework given 
the time lag between the initial investment a nd sizeable returns. Uncertainty about future 
electricity prices, market struct ure and conditions and about futu re energy and climate change 
policies poses a major risk to long-term investme nt in the energy sector. This is particularly 
important for nuclear energy, due to the high cap ital investment associat ed with construction 
of a new NPP and the relatively long period befo re any such investment starts to show a 
profit. In practical  terms, investments of approximately 900 billion euros are estimated in the 
EU energy generation with a 2030 horizon. As far as nuclear construction, currently, two 
1600 MWe European Pressurized Reactor (EPR) reactors are being built: in Finland (3rd Unit 
of the Olkiluoto NPP) and at Flamanville, France; expected to be operational by 2012. 
Finland is also starting the procedure for the possi ble construction of a 6th reactor, and EDF 
(France) is planning more EPR reactors by 2020- 30. Other on-going, or firmly planned, new 
build in the EU are the two units of the Bele ne AES-92 VVER in Bulgaria, Units 3 and 4 of 
the Mochovce VVER in Slovakia, and Units 3 and 4 of the Cernavoda CANDU NPP in 
Romania (unit-2 connected to the grid in 2007 ). In January 2008 the UK government gave the 
go ahead for new nuclear build, stating that nucl ear power should play a role in providing the 
UK with clean, secure and affordable energy. Ital y has also taken a deci sion in principle to 
reconsider nuclear power as a possible energy source. It is th erefore important to try to 
establish firm policy frameworks so that th e conditions are clear and predictable for new 
investments. The absence of an EU legisla tive framework creates uncertainties for the 
investors.  
c) Social impact 
A factor to be taken into account, which influences the debate on the future of nuclear power, 
is the issue of public opinion, because of its imp act on the political decisions to be taken and 
of the legitimate right of population to be i nvolved. Public opinion and perception of nuclear 
power is paramount to the future of nuclear polic y. It is essential that the public has access to 
reliable information and can participate in a transparent decision-ma king process. Public 
confidence and acceptance are inextricably tied to  safety which itself has a direct impact on 
operating the facility without incidents. The ac tive participation of al l stakeholders in all 
appropriate phases of a NPP project  is essential. They are very visible activities that need 
strong involvement from all stakeh olders, especially c itizens who are direc tly affected. It is 
essential that this involvement is established in a transparent way and that public trust in the project is established at  the earliest stage.  
Until now, even though the safety and reliability record of EU nuclear power is excellent, 
nevertheless the public does not have the highest confidence in nuclear safety. According to 
the Eurobarometer on nuclear safety
36, most citizens think that they are not well informed 
about nuclear safety. Even if Europeans on averag e have a fair level of knowledge of nuclear 
issues, in particular whether or not  there are NPP in their countries, they feel unfamiliar with 
                                                 
35 COM(2007) 565 final 
36 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  
 
EN 25   EN the issue of nuclear safety (ranging from 56% to 90%) . In this context, it should be 
underlined the fact that even in countries with  a high share of electri city produced from NPPs, 
the percent of citi zens who do not feel inform ed about nuclear safety-r elated issues is high 
(e.g. France – 84%, Lithuania - 82%). 
 
source: Eurobarometer no 271 "Europeans and nuclear safety" 
In the light of the above considerations, an en larged EU needs a common approach in the field 
of nuclear safety as the current system of each  Member State operating its own set of safety 
rules is too complicated and confuses the publ ic’s understanding of how nuclear safety is 
regulated. The lack of a common nuclear safety  framework at EU level can have negative 
effects on the public confidence in nuclear safety matters.  
5.2. Policy option 1  - Community legislation setting up comm on safety standards for existing 
nuclear installations 
The impact of this approach was already de tailed in the Impact Assessment accompanying the 
previous Nuclear Safety proposal37 . As presented in 2004, this option was not acceptable to 
the Council. Therefore, only a s hort summary is given below. 
a) Safety-related impact   
The Commission has actively intervened in co nnection with the harmonisation of nuclear 
safety practices for over 25 years. Despite its efforts, nuclear safety measures differ 
considerably from one Member State to another. It  is necessary to consider nuclear safety in a 
Community perspective. The Commission c oncluded that only a common approach can 
guarantee the maintenance of a high level of nuclear safety in an enlarged EU. This 
conclusion is still valid, while the implementati on needs to be tailored to the existing safety 
arrangements in place in the Member States, in line with the subsidiarity principle. 
b) Competitiveness impact 
The beneficiaries of the proposed actions will be the operators of nuclear  installations and the 
national safety authorities, as th e objective of the proposal is to introduce basic obligations 
and general principles for the sa fety of nuclear installations. 
                                                 
37 included in COM 2003/32 final  
 
EN 26   EN c) Social impact 
The public acceptance of nuclear energy may increas e, in particular in Member States which 
have no nuclear industry or in which public conf idence in national safety regulation is low.  
d) Environmental impact 
Policy option 1 has no direct environmental impact.  
e) Impact on the EU budget  
The financial impact is detailed in the 2003 Impact Assessment which estimated the following 
overall multi-annual estimate of expenditure at 247 000 euros, excluding staff costs. 
5.3. Policy option 2  – Community legislation set ting up a common framework of 
internationally recognised principles, supplem ented by implementing measures prepared by 
the HLG 
a) Safety-related impact  
All the technical analysis supporting the proposed  reference principles and highlighting their 
role for the improvement of the safety culture ha s already been done at different expert levels 
(for a detailed descriptio n of their activity – see Annex of  the present Impact Assessment).  
Also, these fundamental nuclear safety prin ciples have already been recognised at 
international level, within the Convention on Nuclear Safety, to which Euratom and all the 
EU Member States are Contr acting Parties and consequently, submit National Reports on the 
implementation of their obligations for the Re view Meetings of the Parties. Therefore, 
binding Community legislation r ecalling principles already unan imously endorsed at EU level 
would only add value to the existing cooperati on between the Member States within the 
Review Meetings that provide a forum for the exchange of good practices and information in 
the field. This approach is also endorse d by the Council in the WPNS SG 1 Report38, 
according to which " The CNS process is an incentive approach for improving regulatory and 
safety practices in a general sense through positive examples, questions and peer review 
comments. In this way the CNS promotes harm onisation in the broad sense of the regulatory 
and safety issues covered. Especially it seems to have been an efficient driving force for 
improvements of the legal basis and the re gulatory framework. The CNS is the only 
international convention obliging parties to repo rt on the status of nuclear power plant safety 
in their countries. As such the CNS has a very important role for improvement of nuclear safety worldwide, enhanced by the fact that all states with operating nuclear power plants 
now have ratified it." 
This approach is also supported by the May 2007 Council Conclusions on Safe management 
of spent nuclear fuel and radioactive waste,  which identify amongst the actions related to 
harmonised approaches, shared knowledge and joint e fforts in the area of the safety of nuclear 
installations, the "Promotion of the practical use of  current international contexts 
(Convention on Nuclear Safety, Joint Convention,  IAEA, OECD/NEA, WENRA) at EU-level in 
terms of common approaches and good practices to the safety of nuclear installations and 
how the results are used, also taking into ac count the interaction between the different 
contexts. The work at EU-level has to build on the existing high level of cooperation which 
shall be maintained and encouraged by EU Member States and the Commission." The same 
solution is also proposed in the Maldeiki s Report on Assessing Euratom – 50 Years of 
European nuclear energy policy, where the Eu ropean Parliament, after underlining the 
                                                
 
38 15475/2/06 REV 2 ADD 1 
 
EN 27   EN absence of appropriate EU legislatio n in the field of nuclear safety, " calls on the Commission 
to draw on the experience gained from implem enting the conventions governed by the IAEA 
(Convention on Nuclear Safety and the Joint Convention on the Safety of Spent Fuel 
Management and on the Safety of Radioactive Waste Management) and to take account of the 
assessments, conducted by the OECD’s Nuclear Energy Agency (NEA), of the most advanced 
national practices in the field of radioac tive waste management; not es that concerted 
initiatives, such as those carried out by the Western Europe Nuclear Regulators Association 
(WENRA), to develop a joint approach to nuclea r safety, are likely to help with drawing up a 
basis for legislation ". Also, in its Opinion on the Nuclear Illustrative Programme39, the 
European Economic and Social Committee states that it  "agrees with the Commission's 
present view that the common nuclear safety  reference levels and their appropriate 
implementation should be built on the extensive exp ertise of Member States' national nuclear 
safety authorities in collabor ation within WENRA. Any othe r approach could possibly put in 
some member states the present hi gh safety performances at risk ".  
Moreover, the approach under review recognises the principle of natio nal responsibility for 
the safety of nuclear installations in a Co mmunity framework. This is why the detailed 
implementing rules necessary for putting into practice the Community framework will be 
prepared within a formalised forum, the HLG,  comprising representatives of the regulatory 
and safety authorities from all the EU Member States, on a “as needed” basis. This solution is 
fully in compliance with the principle of subsidiarity that requests the EU not to take action unless Community action is more effective than action taken at national, regional or local 
level. 
b) Competitiveness impact 
Nuclear power has traditionally shown a combination of higher construction and lower 
operating costs than fossil-fuel-based energy production, which exhibits lower capital costs 
but higher and potentially fluctuating fuel and, hence, operating costs.  
Nuclear construction lead times are, for engine ering and licensing reason s, much longer than 
for combined cycle gas turbines ( CCGT) or renewable energy sources. 
The economic competitiveness of nuclear power depends on several factor s, with construction 
times, capital costs, waste disposal, decomm issioning and the operational capacity factor 
playing a key role. The private sector will be ultimately resp onsible for proposing, developing 
and operating new NPPs. Hence, it will be the private sector, including developers and financial institutions, which will bear many of the procedural risks involved in furthering the 
nuclear option. Both private and pu blic institutions woul d release loans only if  safety features 
are accomplished by the applicant. Setting up a Community approach on nuclear safety, while 
maintaining rigorous safety and quality standards,  will increase the competitiveness of nuclear 
energy, by allowing shorter and more predic table licensing processes, thus mitigating 
construction risks.  
The range of levelised costs of  generating electricity, with 10 % discount rates and C costs at 
30$/tCO2 (1€ = 1.25 $) is presented in the figure below.  
                                                
 
39 2007/C 256/11 
 
EN 28   EN –  
source: COM(2007) 565 final 
c) Social impact 
The elaboration of a common nuclear safety EU framework will have as a result the increase 
of the degree of public acceptance towards nuclear  energy by efficiently addressing societal 
expectations on public access to information and public participation to the decision-making 
process, in the context of nuclear activities . Such an approach will ensure an open and 
transparent communication of the Community with the public in the field of nuclear safety, 
especially having in view the results of the 2007 Eurobarometer on nuclear safety (for details, 
see the assessment of the soci al impact of Policy option 0).  
d) Environmental impact 
Within the concept of the European Atomic Energy Community, human beings (“workers and 
the general public”) are protected  against the dangers arising from ionising radiation and 
aspects of the environment (water, air, soil) in so far as this is  necessary to protect the human 
health. In this context, the intrinsic link betw een radiation protection and nuclear safety is 
confirmed in the European Cour t of Justice judgement from 10 December 2002 in the Case C-
29/99, according to which “ it is not appropriate, in order to define the Community’s 
competencies, to draw an artific ial distinction between the prot ection of the health of the 
general public and the safety of sources of ionising radiation. ” 40 
In the area of nuclear safety, important as pects of environmental protection go beyond the 
scope of the Euratom Treaty. However, ther e is a major environmental dimension.  
Nuclear installations and their operation present potential hazards and have to be managed in 
ways that ensure the protection of people and the environment, now and in the future, against 
the dangers arising from the ioni sing radiation which they emit. 
Technical solutions exist that meet these objectives and are based on shared common 
principles of a high level of safety. The cont inuing improvement and implementation of these 
                                                 
40 paragraph 82 Figure 11b:  Electricity Generation Costs in High Discount rate Case
01020304050607080
On Shore 
Wind Nuclea r CCGT Coal Steam IGCC7080
60
50
40
30
20
10
0Nuclear High 
Nuclear Low 
CO2 
Range 
Fuel 
O&M 
C&C range on 
Capacity facto r
 
EN 29   EN solutions and principles by Member States sh ould ensure that a uniformly high level of 
protection within their respect ive territories is reached. 
However, policy option 2 has no direct environmenta l impact at this stage, as it proposes only 
a set of Community nuclear safety principles. Nevertheless, the environmental impacts of the 
future implementing measures prepared by the HLG will be further assessed when appropriate.  
e) Impact on the EU budget  
No impact on the EU budget can be foreseen, as this policy option proposes only a set of 
Community nuclear safety principles. Neverthele ss, the HLG has in principle the possibility 
to propose implementing measures with a financial impact on both the national administrations and/or the utilities operating N PPs or willing to put forward new investments. 
Such cases will be assessed on a case by case basis if and when specific measures are put forward.  
5.4. Policy option 3  
- Community legislation set ting up a common framework of 
internationally recognised pr inciples, obligations and requi rements, supplemented with 
additional safety requirements for new nuclear power reactors,  that Member States are 
encouraged to develop. 
The main differences of this proposed approach from the 2003/ 2004 proposals are the 
following:  
– Decoupling from waste issues. One of the major political obstacles of the previous 
proposals, the regulation of decommissi oning funds, is not there anymore. 
– Very strong powers of the regulators have been  written down clearly, e .g. the power to shut 
an installation down. This will strengthen the position of regulators in the EU. 
– The HLG did not exist at the time of the old proposals. In the new draft, it will become a 
focal point of cooperation between national regulators; also, if deciding to define 
additional safety requirements for new nuclear  power reactors, Memb er States should us 
use the expertise of the HLG and work in cl ose cooperation with it.. This upgrading of the 
HLG will closely involve the Member States and strengthen the national regulators, as the members come from the na tional regulatory bodies. 
a) Safety-related impact   
This policy option  has as a foundation  the conceptual structure of Policy option 2 
(establishing at EU level a framework of basic internationally recognised and endorsed 
nuclear safety principles). The considerations  presented for the assessment of the safety 
impact of Policy option 2 apply mutatis mutandis  for Policy option 3.  
The proposed Community framework on nuclear safe ty should aim to the achievement of the 
following internationally endorsed fundamental principles : 
Enhancing the role of the national regulators 
The regulatory body should be provided with ad equate authority, comp etence and financial 
and human resources to fulfil its  responsibilities (e.g. supervisi on and regulation of the safety 
of nuclear installations, ensuring of the implem entation of safety requirements, conditions and 
regulations, granting licences and monitoring thei r application). This principle is already 
endorsed in Article 8, paragraph 1 of the Co nvention on Nuclear Safety, as well as in 
Principle 2 of the IAEA Safety Fundamentals. 
 
EN 30   EN In this context, the safety measures and contro ls to be implemented in a nuclear installation 
shall be decided only by the regulatory body and subsequently realised by the licence holder.  
Also, in order to continuously improve the re gulatory infrastructure , the regulatory body and 
the national regulatory structure should be subj ect to periodic interna tional peer reviews.  
Enshrining in Community legisl ation such provision would only add value by supporting and 
strengthening the already ex isting competencies of the national regulatory bodies.  
Prime responsibility of the li cence holder for safety under th e control of the regulatory 
body  
The principle of the responsibility of the licence  holder for the safety of a nuclear installation 
has already been widely accepted, as it is al ready recognised by the Convention on Nuclear 
Safety (Article 9) and by th e IAEA Safety Fundamentals (P rinciple 1). The WPNS SG1 
Report also concludes that "While the prime responsibility for implementing the defence-in-
depth rests with the licence hol ders (operators), the implementati on has to be ensured by an 
effective national regu latory framework for nuclear safety."  
Reinforcing the independence of the regulatory body 
In order to facilitate autonom ous decisions giving priority to  nuclear safety, the independence 
of the regulatory body, effectively separated from  any other organization 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) and in the IAEA Safety Fundamentals (Principle 2). 
One of the conclusions highlighted in the WPNS  SG1 Report, in the se ction dedicated to the 
Convention on Nuclear Safety and to the asse ssment of its review meetings, was that "the 
CNS process is providing incentiv es to improve national practices , and thus to harmonise at a 
high level" . Furthermore, it is stated that "a development has taken place during the three 
review processes towards a common unde rstanding of safety issues, to broaden 
implementation of evolving safety concepts, e.g. safety management, and to further develop 
conceptual issues, e.g. independence of regulat ory bodies. The CNS has been a major driving 
force to harmonize the legal bas is and the regulatory framewor k of the Contracting Parties 
(articles 7, 8,  9) and to provide adequate resources for the regulatory bodies and operators 
(article 11)." 
A revised nuclear safety proposal should follow the same approach and aim 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 2004 directive proposal.  
Ensuring a high level of transparency on issues related to the safety of nuclear 
installations 
A high level of transparency on is sues relating to the safety of nuclear installations should 
consist in the provision of inform ation to the public in an ac curate and timely manner about 
important nuclear safety matters.  
Implementation of management systems 
A future EU framework should establish princi ples governing the licence holders' obligations. 
One of these principles is their obligation to put in place management systems, concept which 
is included in Principles 1 on the responsibilit ies of the licence holder and explained more in 
detail in Principle 3 of the IAEA Safety Fundamentals, according to which it "has to integrate 
all elements of management so that require ments for safety are established and applied 
coherently with other requirements, incl uding those for human performance, quality and 
 
EN 31   EN security, and so that safety is not compro mised by other requirements or demands. The 
management system also has to ensure the promotion of a safety culture, the regular 
assessment of safety performance and the applic ation of lessons learned from experience". 
Such management systems should be re gularly verified by the regulatory body  
Regular safety supervision 
Nuclear safety supervision (assessments, inve stigations, control and enforcement actions) 
carried out by the regulatory body throughout the w hole lifetime of installations responds to 
the obligation of assessment and verification of safety set up in Article 14 of the Convention on Nuclear Safety. In order to strengthen the po wers of European regulators, a EU Directive 
should provide for extended regulatory powers in th e interest of safety, by clearly spelling that 
in case of serious or repeated safety rules breaches, the regulatory body shall have the power 
to withdraw the operating licence, to order the st op of operations of any pl ant if it deems that 
safety is not fully guaranteed as well as to allow the restart of operation.  
Availability of nuclear safety expertise 
The availability of nuclear safety experts is an extremely important issue which comes up at 
every international meet ing concerned with nuclear safety. The past decades have not trained 
enough specialists, so that there is also th e problem of aging of safety personnel and 
inspectors, of which many are approaching reti rement. This is an area where the Community 
can assist with helping trans-national cooperati on and training. The obli gation to ensure the 
availability of sufficient and qua lified staff is also recognised in  Article 11 paragraph 2 of the 
CNS.
 WPNS SG1 Report noted on human resources that  "To develop and maintain an 
effective defence-in-depth of a nuclear facil ity, an appropriate operating organisation with an 
effective management syst em has to be in plac e, providing a strong management commitment 
to safety and a strong safety culture. This means e.g. that…sufficient number of adequately 
trained staff is available". 
Priority to safety 
The main aim of the Member States' legisl ative and regulatory systems should be the 
achievement of the highest level of safety in nuclear installations. This objective is also provided for in Article 10 of the Convention on Nuclear Safety. 
Moreover, the possibility of Member States to impose at national level more stringent safety 
measures should be provided in the Community legislation. A similar le gal provision is also 
included in Article 54 of the Basic Safety Standards Directive, "If a Member State is to adopt 
dose limits which are stricter t han those laid down in this Di rective, it shall inform the 
Commission and the Member States"  
Until now, the safety and reliability record of EU NPPs is excellent. Nevertheless, since 
nuclear power provides one third of Europe’s elect ricity and the typical initial design life of 
an NPP is currently 40 years, cu rrently, decisions are required on extension of the life of some 
plants, where safely possible, or on new investments, in orde r to meet the expected demand 
and to replace ageing infrastruc ture over the next 20 years. A significant number of NPPs are 
indeed due to close down within the next 20 y ears. Taking into account the current EU energy 
mix, if the planned phase-out policy in some EU Member States is maintained, without 
extending plant lifetime and/or new construc tion, nuclear energy's share of electricity 
production will be significantly reduced. In this  context, policy option 3 aims to go further 
than setting up a set of nuclear safety principles and it encourages Member States to establish additional safety requirements for the safety of the  new power reactors, taking as a basis the 
WENRA safety levels and in close cooperati on with the HLG. The WENRA Reactor Safety 
safety levels cover a wide range of fields covering Safety Policy, Operating Organisation, 
 
EN 32   EN Management System, Training and Authorizatio n of NPP staff, Desi gn Basis Envelope for 
Existing Reactors, Design Extension of Existing Reactor, Safety Classification of Structures, 
Systems and Components, Operational Limits  and Conditions, Ageing Management, System 
for Investigation of Events and Operational Experience Feedback, Maintenance, In-service 
inspection and Functional Testing, Emergency Op erating Procedures and Severe Accident 
Management Guidelines, Conten ts and updating of Safety Analysis Report, Contents and 
updating of Safety Analysis Repor t, Probabilistic Safety Analys is, Periodic Safety Review, 
Plant Modifications, On-site Emergency Prepare dness, Protection against Internal Fires.  
A projection of the exp ected nuclear capacity to provide the nuclear share of electricity 
generation in the EU assuming planned closedow n of reactors and potential lifetime extension 
or/and new build is presented below. 
Figure 5 : Evolution of nuclear production capacity  vs 
forcasted nuclear share of the primary energy demand (EU-25)
020406080100120140
1990 2000 2010 2020 2030Installed capacity, GW(e )
0%2%4%6%8%10%12%14%16%
Nuclear shar e
Existing, calculated from PRIS (IAEA)
data w ith 40 Y lifetime*
World Nuclear Outlook 2006 (WNO'06)
With lifetime extention and/or new  build
Nuclear share in Primary Energy demand
Sources PRIS; European Energy & Transport, Trends to 2030, update 2005 (L Mantzos & P Capros) and World Energy Outlook 2006WNO'06  
APS scenario
* from PRIS data, considering actual constructions + Life Extention when applicable, and 32Y German Phasing out
 
source: COM(2007) 565 final 
b) Competitiveness impact   
The considerations presented for the assessment of the safety impact of Policy option 2 also 
apply mutatis mutandis  for Policy option 3.  
c) Social impact 
The considerations presented for the assessment of the safety impact of Policy option 2 also 
apply for Policy option 3.  
d) Environmental impact 
The considerations presented for the assessment of the safety impact of Policy option 2 also 
apply for Policy option 3.  
e) Impact on the EU budget  
No additional financial burden for the EU budget, as the licence holder should possess the 
adequate financial resources for fulfi lling its nuclear safe ty obligations.  
 
EN 33   EN SECTION 6: COMPARING THE OPTIONS  
By comparing the individual impacts per option, the following conclusion s can be drawn from 
the Impact Assessment: 
Policy option 0  can not be accepted, taking into consider ation the fact that the absence of 
Community legislation would be prejudicial to Community citizen s and to the interest of the 
enlarged EU. Despite a certain degree of harm onisation, today the nuclear  safety procedures 
and practices still vary from one Member State to another and this diversity of measures does 
not allow the Community to satisfy itself that the health protection requirements of Article 
2(b) of the Euratom Treaty are applied in th e most effective way. Therefore, Community 
intervention is indispensable to  guarantee the maintenance of a high level of nuclear safety 
within the EU. 
Policy option 1  was considered for the elaboration of  the proposal of Directive setting out 
basic obligations and general principles on the sa fety of nuclear installa tions. Having in view 
the fact that the proposals of the Nuclear Safety Package have not been adopted by the 
Council until present, this Policy option has not pr oved to be a feasible one in the light of the 
necessity to achieve a progress in developing an EU harmonise d approach in the area of 
nuclear safety. Nevertheless, it should be unde rlined the fact that, although not yet adopted, 
those proposals have set in motion a process l eading to greater awareness of the need to 
establish a Community framework linking the work of national safety authorities. 
Policy option 2  is completely in line with the conc lusions adopted by the Council of EU, as 
well as by the European Council, requesting that nuclear safety should be exercised in an EU-
framework (see Section 2.5). However, in order to achieve a progress in developing nuclear 
safety at EU level, the proposed Community fra mework should not be restricted simply to 
taking over a set of basic principles. 
In the framework of the above considerations, Policy option 3  appears to be the preferred 
approach, as it presents the highest range the be nefits, by going beyond the level of principles  
A comparative overview of the impacts is presented in the table below.  
Table: Impact Assessment: Overview of the impacts 
Policy 
option Safety impact Competitiveness 
impact Social impact Environmental 
impact Impact on 
the EU 
budget 
Option 0 
Business as 
usual (no policy 
change)  
 - Absence of a 
harmonised nuclear 
safety Community framework. 
- The safety of 
nuclear installations 
is the responsibility 
of the nuclear operators under the 
supervision of their 
national authorities. 
- Different national 
regulatory systems. - 
Member States' measures differ 
considerably from 
one MS to another. -The most crucial 
factor affecting the 
prospect of growth of nuclear power is its 
underlying economics 
as a NPP involves an 
up front investment 
ranging from €2 to €3.5 billion. 
-The EU recognises 
the importance of maintaining a 
technological lead in 
the field of nuclear energy 
- The absence of an 
EU framework establishing a - One of the 
driving factors of 
the future development of 
nuclear energy is 
public 
acceptance. 
- According to the 
2007 survey on 
nuclear safety, the 
European citizens feel unfamiliar 
with the issue of 
nuclear safety (ranging from 
56% to 90%) . 
- The existence of 
national - - 
 
EN 34   EN Policy 
option Safety impact Competitiveness 
impact Social impact Environmental 
impact Impact on 
the EU 
budget 
- To meet the increasing energy 
demand and to 
reduce European dependency on 
imports, decisions 
should be made on new investments or 
on the life extension 
of some plants. 
- The lack of a 
common nuclear 
safety approach will have a negative 
effect on the long 
term on the future development of 
nuclear energy at 
EU level. 
 comparable level of 
nuclear safety 
between the Member 
States will create uncertainties for the 
investors.  
 regulatory 
systems will only 
perpetuate the  
current lack of information in the 
field. 
Option 1 
Community 
legislation 
aiming to 
establish common 
safety 
standards for existing 
nuclear 
installations 
 -Nuclear safety 
measures differ considerably from 
one Member State 
to another.  
-It is necessary to 
consider nuclear 
safety in a Community 
perspective.  
-Implementation 
needs to be tailored 
to the existing 
safety arrangements in place in the 
Member States, in 
line with the 
subsidiarity 
principle. -The beneficiaries of 
the proposed actions will be the operators 
of nuclear installations 
and the national safety authorities, as the 
objective of the 
proposal is to introduce basic 
obligations and 
general principles for the safety of nuclear 
installations. -The public 
acceptance of nuclear energy 
may increase, in 
particular in Member States 
which have no 
nuclear industry or in which public 
confidence in 
national safety regulation is low.  
 -Policy option 
1 has no direct environmental 
impact at this 
stage, as it proposes only 
a set of 
Community nuclear safety 
principles.  
-Nevertheless, 
there may be a 
substantial 
beneficial impact 
resulting from 
the future 
implementing 
measures prepared by 
the HLG. - 
Estimations 
of the 
overall 
multi-annual 
estimate of 
247 000 euros, 
excluding 
staff costs. 
 
Option 2 
Community 
legislation 
setting up a 
common nuclear 
safety 
framework (widely 
recognised 
principles) + implementin- Set of widely 
recognised nuclear safety principles, 
enshrined in the 
IAEA Convention on Nuclear Safety: 
- Euratom and all 
the Member States are Contracting 
Parties to the 
Convention (subsequently, they - The establishment of 
a common approach in the field of nuclear 
safety will lead to the 
increase of the nuclear energy' 
competitiveness, by 
reducing the industry's investment risks The elaboration 
of a common nuclear safety EU 
framework will 
have as a result the increase of 
the degree of 
public acceptance towards nuclear 
energy - No direct 
environmental impact (this 
Policy option 
proposes only a set of 
Community 
nuclear safety principles).  
-The 
environmental impacts of the - No impact 
on the EU budget can 
be foreseen, 
as this policy 
option 
proposes only a set of 
Community 
nuclear safety 
 
EN 35   EN Policy 
option Safety impact Competitiveness 
impact Social impact Environmental 
impact Impact on 
the EU 
budget 
g measures prepared by 
the HLG 
 elaborate National 
Reports and 
participate at the 
regular Review Meetings). 
- Implemented rules 
prepared by the HLG (comprising 
high-level 
representatives of the regulatory and 
safety authorities 
from all the EU Member States) → 
subsidiarity 
principle. 
 future 
implementing 
measures 
prepared by the HLG will 
be further 
assessed when appropriate.  
 principles.  
- 
Nevertheles
s, the HLG has in 
principle 
the possibility 
to propose 
implementing 
measures 
with a financial 
impact on 
both the national 
administrati
ons and/or 
the utilities 
operating NPPs or 
willing to 
put forward new 
investments
. Such cases will be 
assessed on 
a case by case basis if 
and when 
specific measures 
are put 
forward.  
 
Option 3 
Community 
legislation 
setting up a 
common framework 
of 
internationally 
recognised 
principles, obligations 
and 
requirements, 
supplemente
d with additional -See the 
considerations from Policy option 2. 
-Additional 
element: Member States are 
encouraged to 
define additional safety requirements 
for new nuclear 
power reactors, using as a basis the 
WENRA safety 
standards and in cooperation with 
the HLG. 
 - See the 
considerations from Policy option 2. 
-  - See the 
considerations from Policy 
option 2. - See the 
considerations from Policy 
option 2. No 
additional 
financial 
burden for 
the EU 
budget, as 
the licence 
holder should 
possess the 
adequate financial 
resources 
for fulfilling its 
nuclear 
safety obligations 
 
EN 36   EN Policy 
option Safety impact Competitiveness 
impact Social impact Environmental 
impact Impact on 
the EU 
budget 
safety requirement
s for new 
nuclear power 
reactors, that 
Member States are 
encouraged 
to develop.  
 
SECTION 7: MONITORING AND EVALUATION  
The indicators of progress towards meeting the objectives will be set up at the level of the 
Member States, solution which is in full complian ce with the principle of subsidiarity and it 
does not hamper the principle of the na tional responsibility for nuclear safety. 
An additional monitoring of the Directive's results will be achieved by means of the HLG 
obligation set up in its founding Commission Decisi on to regularly submit to the Commission 
a report of its activities. Furthermore, the Commission shall transmit this report to the 
European Parliament and the Council. 
As an additional remark, it should be noted that the reporting of the h ealth protection of the 
public and workers falls outside the scope of the current revised Directive, as it is covered by 
the radiation protection acquis. Also, there ar e health-related reporti ng mechanisms under the 
International Nuclear Event Scal e (INES scale) which represents  a means for promptly 
communicating to the public in consistent terms the safety significance of events reported at 
nuclear installations. Events are classified on the Scale at 7 levels ; the upper levels (4 −7) are 
termed accidents and the lower levels (1 −3) incidents. In addition,  monitoring of air, water 
and soil are established in Articles 35-36 of th e Euratom Treaty and regularly carried out by 
the Commission services. 
ANNEX 
Overview of the consultations and technica l expertise supporting the approach of the 
proposed Directive setting up a Comm unity framework for Nuclear Safety 
1. CONSULTATIONS ON THE NECESSITY OF A COMMUNITY NUCLEAR SAFETY LEGISLATIVE 
FRAMEWORK  
1.1 Consultations under Article 31 of the Euratom Treaty 
Article 31 of the Euratom Treaty defines the procedure for the adoption of the basic safety 
standards provided for in Article 30 for the protec tion of the health of workers and the general 
public against the dangers arising from ionising  radiation. According to the Treaty, these 
standards shall be worked out by the Commissi on after it has obtained the opinion of a group 
of persons appointed by the Scientific an d Technical Committee from among scientific 
experts, and in particular public health expert s in the Member States. Also, the Commission 
shall obtain the opinion of the Economic and Social Committee on these basic standards. 
 
EN 37   EN In relation to the first consultation, the Co mmission submitted in 2002 its draft legislative 
proposals to the Article 31 Group of experts. The Group of experts s upported the Commission 
initiatives and urged it to continue its efforts as regards harmonisation. The discussions within 
the group made it possible to clarify some in accuracies. Texts were therefore amended in 
order to take into account constructive cri ticisms formulated by the Group of experts. 
Subsequently, the 2003 opinion of the European  Economic and Social  Committee concluded 
that the Committee "reaffirms the basic obligation of the Member States and the Community 
to guarantee the safety of nuc lear installations and the dis posal of radioactive waste; 
fundamentally endorses the Commission's initiative to  achieve this, in particular also with a 
view to harmonising regulatory systems and in anticipation of enlargement". 
1.2. Stakeholders consultation 
In addition to the consultations resulting from the legislative procedure provided for in the 
Euratom Treaty, the Commission carried out numer ous consultations, with both the national 
authorities and industry, individu ally or collectively through various fora. Consultations were 
also undertaken with international organiza tions, such as the IAEA and the NEA. The 
Commission took also adva ntage of its participation in va rious international meetings to 
present its plans for EU regulation in the field of nuclear safety. On this point, the following 
events should in particular be rated:  
– European Nuclear Society Conference (France, October 2002);  
– International Conference on issu es and trends in radioactiv e waste management (Austria, 
December 2002);  
– International conference on wa ste disposal in geological formations (France, January 
2003);  
– International waste management symposiu m (the United States, February 2003);  
– Nuclear waste, second parliamentar y meeting (France, March 2003);  
– Meeting with the Group of European municipa lities with nuclear facilities (Belgium, 
March 2003);  
– Conference organized by the “Consejo de se guridad nuclear” in San Lorenzo de El 
Escorial (Spain, July 2003);  
– General assembly of the World associati on of Nuclear Operators –WANO - (Germany, 
October 2003);  
– International symposium on the harmonization of nuclear safety approaches (Germany, 
October 2003);  
– Eurosafe 2003 (France, November 2003);  
– The European discussions: nuclear wast e management (France, November 2003);  
– International conference on geological repositories (Sweden, December 2003);  
– Energy choices for Europe 2004 (Belgium, March 2004);  
– Euradwaste (Luxembourg, March 2004);  
– First parliamentary meeting on nucl ear energy (Belgium, April 2004);  
– Meetings of WPNS (2004-2006); 
 
EN 38   EN – Meetings of the Nuclear Regulators’ Work ing Group (NRWG), Reactor Safety Working 
Group (RSWG) and CONCERTation on Eur opean Regulatory Tasks (CONCERT), 
presented below (2005-2006); 
– 4 meetings of the HLG (2007-2008); 
– 3 meetings of the European Nuclear Energy Forum (2007-2008). 
These various meetings made it possible to pr esent the legislative proposals and to follow 
their development throughout th e discussion process with the European Parliament and the 
Council.  
2. OVERVIEW OF THE ACTIVITY OF EXPERT GROUPS IN THE FIELD OF THE HARMONIZATION 
OF NUCLEAR SAFETY APPROACHES  
2.1. NRWG and RSWG 
The Commission has worked with the support of  expert groups for more than 30 years and 
has launched many studies and initiatives in the fi eld of nuclear safety. 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 dea ling with nuclear inst allation safety. The 
NRWG, which met last in June 2005, include s representatives of nuclear regulatory 
authorities from EU Member St ates and Candidate States of Central and Eastern Europe. The 
RSWG, which included all the EU regulatory bodies and industry, wa s discontinued in 1998. 
Their approach to harmonisation consisted in a comparison of national practices, 
identification of common features, and analysis  of the safety relevance of differences. 
Common technical opinions were expressed on certain safety issues, and, while these were 
not safety "standards", they were expected to promote good practi ces. Activities of both 
Groups included safety aspects of ageing, a pplications of risk-b ased approaches and 
innovative technologies. These activities were  widely documented and published either as 
technical publications, or as Communications to the Council and the European Parliament. 
The outcome of the work of these expert groups has provided a sound technical background, 
which can be fully valorised by setting up a fr amework at EU level,  establishing a common 
approach in the field of nuc lear safety regulation.  
2.2. CONCERT 
The CONCERT Group, formed in 1992, was a foru m that brought together EU, Central and 
Eastern European Countries and Newly Indepe ndent States nuclear regulators to share 
experience and to enhance the pr ogress of assistance and co-ope ration programmes in general. 
Among its other activities, the discussions with in this group significantly contributed to 
achieving the objectives of the Conventio n on Nuclear Safety, by forming a common 
regulatory view on nuclear safety issues and de veloping the safety culture. The group held its 
last meeting in 2005. 
2.3. WENRA  
In February 1999, the heads of the Nuclear Regulatory Author ities of Western European 
countries with NPPs decided to create WENRA.  The aim of WENRA wa s to improve nuclear 
safety, thus pursuing, among others , the objective of developing a "harmonised approach to 
selected nuclear safety and radi ation protection issues and th eir regulation, in particular 
within the European Union"41. The terms of reference of WENRA were signed by the chief 
nuclear regulators of Belgiu m, Finland, France, Germany, It aly, the Netherlands, Spain, 
                                                 
41 WENRA Policy Statement, signed in Stockholm in December 2005 
 
EN 39   EN Sweden, Switzerland and the United Kingdom. The main objectives of WENRA at that time 
were to develop a common approach to nucl ear safety and to provide an independent 
capability to examine nuclear safety in the applicant countries. 
In March 2003, WENRA extended its membership to the heads of the Regulatory Authorities 
of all the then EU Candidate Countries with nuclear power programmes. The revised terms of 
reference were signed by the chief regulat ors of Bulgaria, Czech Republic, Hungary, 
Lithuania, Romania, Slovakia and Slovenia, in  addition to the earlier members. After 2003, 
the objectives of the co-operation within WENR A were extended, so that it would become a 
network of chief nuclear safety regulators in  Europe, exchanging experience and discussing 
significant safety issues. 
In order to harmonise safety approaches, tw o working groups were launched. The mandate of 
the working groups was to analyse the current s ituation and the different  safety approaches, 
compare individual national regulat ory approaches with the IAEA Safety Standards, identify 
any differences and propose a way forward to  possibly eliminate the differences without 
impairing the final resu lting level of safety. 
The Reactor Harmonisation Working Group (R HWG), consisting of experts from the 
WENRA organisations, was es tablished in 2000. During 20 00-2002, the group carried out a 
pilot study to develop and test a methodology fo r making systematic comparisons of national 
requirements on selected reactor safety issues and to arrive at conclusions about what needs to be addressed at the national levels in order to reach common safety levels. A main study 
started in 2003 with basically the same me thodology as the pilot study and with additional 
issues to be covered. 
Another WENRA working group, the Work ing Group on Waste and Decommissioning 
(WGWD), has looked into harmonisa tion of the areas of nuclear waste and spent fuel storage 
and decommissioning of nuclear facilities. 
In January 2006, two reports on reference levels  in these areas were published. In connection 
with publishing, WENRA invited stakehol ders to comment on the reports. 
As a result, WENRA members have defined many common safety reference levels for power 
reactors with a view to align national requirements by the year 2010. 
A first revision of the reference levels rela ted to reactor safety has been published by 
WENRA in January 2007, as a re sult of comments by stakehol ders on the report published in 
January 2006. 
The RHWG has given further cons ideration to some issues raised by the stakeholders. As a 
result of this work, WENRA memb ers have decided to slightly modify some reference levels 
to further clarify their intent . A revision of the RHWG Safety  Reference Levels was published 
in March 2007. 
In January 2008, WENRA published a new revision of the reference levels applicable to 
reactor safety, reflecting the work of the RHWG  to propose a revised set of reference levels 
on issue C- "Management Systems" as well as  the commitment of WENRA to revise the 
reference levels when new knowledge  and experience are available. 
One of the tasks entrusted to the WPNS was to asses the WENRA reports and action plans. In 
this context, SG1 analysed the WENRA Report on Harmonisation of safety approaches for Nuclear Power Reactors while SG2 evalua ted the WENRA Report on Harmonisation of 
safety approaches for Waste and Decommissi oning. The issues investigated covered the 
extent of harmonised approaches to safety re quirements and implementation, indicated by the 
benchmarking results for the studied issues, and the measures to accomplish harmonised 
 
EN 40   EN approaches for the issues presented in the WE NRA studies that are in cluded in the agreed 
action plans. As a result, one of the conclusions of the WP NS – SG1 Report is that the 
"WENRA methodology is a systematic, docum ented and logical approach to harmonisation" .  
2.4. WPNS  
Following the Council Conclusions on Nuclear Safety and Safe ma nagement of spent fuel and 
radioactive waste, reached in June 2004, a wide  ranging consultation pr ocess was initiated, 
aiming to identify new instrument(s) that can cont ribute more effectively to further improving 
nuclear safety and the safety of the management  of spent fuel and radioactive waste, without 
excluding any instrument, in the framework of the Euratom Treaty and in line with the principles of better law making. 
Subsequently, as a consequen ce of the June 2004 Council Conclu sions, after long negotiations 
on the Commission's proposals for Council (Euratom ) Directives setting out basic obligations 
and general principles on the sa fety of nuclear installations and on the management of spent 
fuel and radioactive waste, WP NS was activated by the WPAQ.  
The Council Conclusions call for an “ extensive consultation ” with stakeholders before any 
instruments in these fields are developed in the framework of the Eu ratom Treaty. According 
to the Conclusions, a basis needs to be develope d for the consultation process, in particular 
taking into account the work conducted by nationa l nuclear regulatory authorities to reach 
harmonised safety approaches. Furthermore, the Conclusions request Memb er States together 
with the Commission " to engage in a wide ranging cons ultation process facilitating the 
choice of instrument(s), in th e framework of the Euratom Trea ty, that can contribute more 
effectively to achieving nuclear  safety and the safe management of spent fuel and radioactive 
waste, without excluding any instrument and in line with the principles of Better law making ."  
On 3 December 2004, the WPAQ agreed on an Action Plan
42 for following up on the Council 
Conclusions. This Action plan iden tified three main action areas: 
– Actions in relation with the safety of nuclear installations; 
– Actions in relation with safety  of the management of spent fuel and radioactive waste; 
– Actions in relation with the financing of th e decommissioning of nuclear installations and 
safe management of spent fuel and radioactive waste. 
The Work Programme43 of WPNS established three subgroup s to address the tasks identified 
therein. The subgroups were assessing the following fields: 
Subgroup 1 (SG1) was assigned the area of Nuclear Installation Safety. 
Subgroup 2 (SG2) was assigned the area of safety of the management of spent fuel and 
radioactive waste (inc luding decommissioning). 
Subgroup 3 (SG3) was assigned the area of  financing of the decommissioning and 
dismantling of nuclear installations and financ ing the safe management of spent fuel and 
radioactive waste.  
The final WPNS Report, comprising overall c onclusions and recommendations, was approved 
by the WPAQ on 13 December 2006. The detailed  methodology, organisation of work and 
data collection, detailed results from data co llection and analysis, an d justification for the 
                                                 
42 15955/04 
43 5574/2/05 REV 2 
 
EN 41   EN conclusions and recommendations are presente d in the attached reports produced by the 
established subgroups. The main sources  of the Reports are the following: 
– International Conventions (Convention on Nucl ear Safety, Joint Convention on the Safety 
of Spent Fuel Management and on the Safety  of Radioactive Waste Management) review 
process; 
– WENRA44 reports and action plans; 
– National use of the IAEA Safety Requirements; 
– Harmonised approaches to nuclear safety, safe  management of spent fuel and radioactive 
waste reached within the work of NEA45/CNRA46, RWMC47, CSNI48; 
– Harmonised approaches to nuclear safety, safe  management of spent fuel and radioactive 
waste reached as a result of Community activities; 
– Study of financial arrangements for decommissioning and the management of spent fuel 
and radioactive waste. 
2.5. HLG 
In 10 January 2007, the Commission adopted a dr aft Nuclear Illustrative Programme that 
proposed the establishment of a High Level Gr oup on nuclear safety, waste management and 
decommissioning. The Brussels European Council from March 2007 endorsed the 
Commission's proposal to establish an EU Hi gh Level Group on Nuclear Safety and Waste 
Management. The Council Conclusions of  May 2007 on Nuclear Safety and Safe 
Management of Spent Nuclear Fuel and Radioa ctive Waste paved the way for the creation of 
the HLG. The conclusions were adopted base d on the results of the work carried by the 
WPNS; they set out a list of possible actions , acknowledging that any new initiatives at the 
EU level should be assessed ag ainst their potential contribu tion to the whole system of 
existing efforts. The actions are connected with the safety of nuclear installations, the safety 
of the management of spent fuel and radioac tive waste as well as the financing of the 
decommissioning of nuclear inst allations and the safe mana gement of spent fuel and 
radioactive waste. The European  Parliament subsequently adopt ed the 50 years of European 
nuclear energy policy report, wherein it regrette d the absence of binding legislation in the 
nuclear safety domain and urged the Commission and the Council to take the necessary steps 
for it, taking note of the initiative to es tablish a High Level Group. On 12 July 2007, the 
European Economic and Social Committee also adopted a favourable Opinion on the content 
of the Nuclear Illustrative Programme. 
The HLG was established by the Commission Decision of 17 July 2007 
(2007/530/Euratom49). According to the Commission Deci sion, the HLG shall 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 wa ste. The HLG may set up working groups or 
subgroups to study specific subjects and it shall every two years submit a report of its activities to the Commission, the European Parlia ment and the Council. With its actions, the 
                                                
 
44 http://www.wenra.org 
45 Nuclear Energy Agency (of the OECD) 
46 Committee on Nuclear Regulatory Activities (NEA) 
47 Radioactive Waste Management Committee (NEA) 
48 Committee on the Safety of Nuclear Installations (NEA) 
49 O.J.  L 195 , 27/07/2007 P. 0044 - 0046 
 
EN 42   EN HLG shall optimise the efforts and results wh ich Euratom and its Me mbers States achieve, 
inter alia , at the IAEA and the OECD NEA. The HLG comprises the Heads of the national 
regulatory or nuclear safety author ities of the 27 Member States.  
By setting up the HLG, the technical work of WENRA in the field of harmonization will be 
widened in a more formal framework, in associ ation with representati ves of the non nuclear 
countries of the EU. The importance of the activ ity carried on at WENRA level is recognised 
and stressed in the May 2007 Council Conclusions on Safe management of spent nuclear fuel 
and radioactive waste. In this framework, the ro le of WENRA is underlined as a reference for 
the future work of the HLG in the fields of sa fety of nuclear installa tions and safety of the 
management of spent fuel and radioactive waste (" Building on the WENRA process with 
regard to further development of Safety Refe rence levels and to how WENRA States, being 
also Member States of the EU, implement the WENRA national action plans, thereby including those countries that  do not operate any nuclear po wer plants and the Commission. 
While the work at EU level shall not duplicat e the WENRA process, all the Member States 
should have the possibility of being informe d, putting questions and further contributing to 
the process done so far."  and " Building on the WENRA activitie s and consideration of its 
relevance to the safety of spent fuel, radioactive waste and decommissioning management in 
the EU. While the work at EU level shall not duplicate the WE NRA process, all the Member 
States should have the possibility of be ing informed, putting questions and further 
contributing to the process done so far" ). 
The HLG met for the first time in October 2007. Three subgroups were established, dealing 
with the following topics: 
– Improvements of nuclear safety arrangements; 
– Improvements in the decommissioning, radi oactive waste management and spent 
fuel arrangements; 
– Improvements in transparency arrangements. 
As far as nuclear safety is concerned, HL G has already concluded that any EU legal 
instrument on nuclear safety should be base d upon the Convention on Nuclear Safety as well 
as on the IAEA Safety Fundamentals. Also, mo st of the members of the HLG actually support 
the revised approach currently proposed. 
The proposed revised Community legislation on nuclear safety should r ecognise the key role 
to the HLG, which will act as a focal point of  cooperation between nuclear regulators and will 
be consulted by the Member States when de fining additional safety requirements for new 
power reactors. For this purpose, its initial ma ndate will be amended accordingly, in order to 
properly reflect its competencies under the Directive.