EN    EN EN 
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 26.11.2008 
SEC(2008) 2893 
  
COMMISSION STAFF WORKING DOCUMENT 
Accompanying document to the 
 
Proposal for a  
 
COUNCIL DIRECTIVE (Euratom) 
 
setting up a Community framework for Nuclear Safety 
 
SUMMARY OF THE IMPACT ASSESSMENT  
{COM(2008) 790 final} 
{SEC(2008) 2892} 
EN 2   EN 1. CONSULTATION AND EXPERTISE  
The Impact Assessment relates to th e agenda planning item 2008/TREN/003 - Revised 
legislative proposal on nuclear safety . It accompanies the draft revised Directive setting up a 
Community framework for Nuclear Safety which ai ms to re-start the process of establishing a 
common EU framework on nuclear safety, by re placing the proposed Di rective setting out 
basic obligations and general principles  on the safety of nuclear installations1 presented by the 
Commission in 2003.  
This new proposal is the result of an extensive and continuous consultation process, initiated 
in 2004 during the Irish Presiden cy of the Council. Subsequen tly, the Council Working Party 
on Nuclear Safety (WPNS), the High Level Gr oup on Nuclear Safety and Waste Management  
(HLG) and the European Nuclear Energy Forum continued work on this issue. 
The consultation process that started in 2004 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 revised legislative proposal on nuclear safe ty builds on: a) the technical work of the 
Western European Nuclear Regulators Associ ation (WENRA) completed in 2006 for existing 
nuclear installations, with the participation of all European nuclear safety regulators; b) the principle that only strong and independent regulators can ensure  the continued safe operation 
of nuclear power plants in the EU; c) enshrining  in the European legislation the principles of 
the main international instruments availabl e, namely the Convention on Nuclear Safety
2 and 
the safety work carried out by the Internationa l Atomic Energy Agency (IAEA), particularly 
its safety fundamental principles3. In addition, the technical background supporting the basic 
principles proposed in the dr aft revised Directive setting up a Community framework for 
Nuclear Safety was provided by the outcome of  the activity of the different expert groups 
dealing with nuclear safety matters.  
The European Parliament has constantly supporte d the setting up of European nuclear safety 
legislation establishing refe rence levels, as illustrated over the years in its Reports4. 
Additionally, as reflected in  the Conclusions of the 2nd European Nuclear Energy Forum, the 
industry is now a firm supporter of EU nuclear safety legislation.  
Finally, for the purpose of finalising the Impa ct Assessment, a Steering Group was set up, 
involving representatives of all the in terested services of the Commission. 
The draft Impact Assessment has been submitted to the evaluation of the Impact Assessment 
Board, which has issued its initial opinion on 9 September 2008, followed by a final opinion 
on 14 October 2008 on a resubmitt ed revised document. The final comments of the Impact 
Assessment Board have been fully taken into account. 
                                                 
1 Initial 2003 Commission proposal (reference doc. COM(2003) 32 final) and revised 2004 version 
(reference doc. 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 The latest were the Maldeikis repo rt on the occasion of 50 years of  the Euratom Treaty (reference doc. 
A6-0129/2007) and the Reul report on conventional energies (reference doc. A6-0348/2007). 
EN 3   EN 2. PROBLEM DEFINITION  
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 implications  for the energy generating industry. As the 
protection of the EU public is one of the main political objectives  of the EU, a legal 
framework aiming to achieve, maintain and c ontinuously improve nuclear safety and its 
regulation in the Community, as well as enhan ce the role of the Member States' regulatory 
bodies would create an additional level of  guarantee for the public in the EU.  
Public acceptance is a 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 establishing common safety standards for the new and existing 
nuclear installations  in the EU. However, the European ci tizens’ concerns about the safety of 
nuclear installations must be properly ad dressed by the Community. One of the main 
conclusions of the 2007 nucle ar safety-related survey5 was that even if Europeans on average 
have a fair level of knowledge of nuclear issues, in particular whether or not there are nuclear 
power plants (NPPs) in their countries, they fe el unfamiliar with the issue of nuclear safety 
(ranging from 56% to 90%). 
3. EU RIGHT TO ACT  
The Community's competence to set up basic 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-29/996, 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 protect the health of work ers and the general public  against the dangers 
arising from ionizing radiations have to be complemented with  safety standards for nuclear 
installations. The technical competence of the national authorities with responsibility for 
safety does not preclude the Community from legislating in this connection. 
4. SOURCES OF THE IMPACT ASSESSMENT  
The Impact Assessment updates the 2003 Impact Assessment related to the initial nuclear 
safety proposal7, having as technical background the conclusions and recommendations 
identified in the Final Report of the WPNS8, approved by the Council Working Party on 
                                                 
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 Commission of the European Communities v Council of the European Union (Case C-29/99) 
7 Included in doc. COM(2003) 32 final 
8 doc. 15475/2/06 REV2 ( http://register.consilium.europa.eu/pdf/en/06/st15/st15475-re02.en06.pdf ) 
EN 4   EN Atomic Questions (WPAQ) on 13 December 2006 and complemented with the findings of the 
WPNS subgroups' reports9.  
In this context, a special em phasis should be put on the activity carried ou t in the framework 
of WENRA, an organisation co mprising the Heads and senior staff members of the Nuclear 
Regulatory Authorities fr om 17 European Countries10, whose members have defined many 
common safety reference levels for power reactors  with a view to align national requirements 
by the year 2010. 
Secondly, the Impact Assessment is based on the obligations 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 
constitute a framework of practices on which national safety requirements are based and to 
the improvement of which Member States have made considerable contributions. 
5. POLICY OPTIONS  
The Impact Assessment considers four policy options :  
– Policy option 0  consists in keeping the current situation unchanged; 
– Policy option 1  envisages the elaboration of Comm unity legislation establishing common 
safety standards for existing nuclear installations;  
– Policy option 2  consists in the elaboration of Comm unity 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 wi dely recognised nuclear safety principles, 
the subsequent implementing measures will be prepared within the HLG; 
– Policy option 3  is built upon a set of  internationally-rec ognised nuclear safety principles 
(approach proposed by Policy option 2), suppleme nted 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 clos e collaboration with the HLG11, comprising high-level 
representatives of the regulatory and safety authorities from all the EU Member States. 
6. COMPARING THE OPTIONS – PROPOSED EU ACTION  
The assessment of the options showed that the most efficient solution for setting up a 
Community nuclear safety fram ework 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 
                                                 
9 doc. 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) 
10 Belgium, Bulgaria, Czech Republic, Finland, France, Germany, Hung ary, Italy, Lithuania, Netherlands, 
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, and UK. 
11 established by the Commission Decision 2007/530/Euratom of 17 July 2007 (O.J.  L 195 , 27/07/2007) 
EN 5   EN 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 IAEA Sa fety Fundamentals, as well as the obligations 
and requirements as incorporated in  the Convention on Nuclear Safety. 
7. ADDED VALUE  
With the renewed interest in nuclear energy in Europe and elsewhere, it is important to 
maintain a high degree of nuclear safety within the EU, to establish a set of binding rules and 
common EU safety standards. The recent announcement of new build of NPPs in the EU makes convergence rules at EU level even more necessary in  order to support the Member 
States in their efforts to harmonise safety practices. Despite the existence of cross-border risks in the operation of nuclear installations, there has been only limited standardisation between countries in the past.  
Within this framework, the fundamental added value  of the chosen policy option is that an 
EU binding legislative framewor k defining basic obligations a nd general principles on the 
safety of nuclear installations, would lead to  the attainment of th e objective of achieving, 
maintaining and continuously improving nuclear  safety in the Community, a result whose 
fulfillment at purely national level would not be as efficient. This approach also presents the clear advantage of an increased certainty of regulation at Community level. Consequently, 
under the institutional provisions of the Euratom Treaty, Euratom possesses its own 
mechanisms to ensure the compliance of the na tional laws of the Member States with the 
Directive's provisions, thus exer cising its role of safeguarding the correct application of the 
Community acquis. Moreover, it should be highli ghted that EU legisla tion confers rights and 
obligations not only for the authorities from each Member State, but as well as for individuals 
and businesses. The authorities in each Memb er State are responsible for implementing EU 
legislation into national law and enforcing it correctly, and they must guarantee citizens’ 
rights under these laws.  
In the absence of an EU legal framework, 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 Parties. Membership entails two basic 
commitments for each Contracting Party: to pr epare and make available a National Report for 
review and to subject its Nationa l Report to a peer review by th e other Contracting Parties.  
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.  
EN 6   EN Finally, the proposal also aims to reinforce th e role and the independence of the national 
regulatory bodies thereby build ing on their competencies, rath er than creating a top-down 
approach, as in the initial nuclear safety proposal . It also reinforces the role of the national 
bodies in the implementation of  the agreed measures, soluti on which is in full compliance 
with the principle of subsidiarity.  
8. 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 new proposal reverses the top-down appr oach of the 2003/2004 proposal to a bottom-up 
one, as, for the safety of new nuclear power reactors, Member States are encouraged to 
develop additional safety requirements, in line with the continuous improvement of safety on the basis of the safety levels developed by WE NRA and in close collaboration with the HLG. 
In addition, Member States retain the right to impose at national level more stringent safety 
measures than those provided for in the Community legal framework. 
Secondly, at the level of 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 accepted principles of the C onvention on Nuclear Safety and of the IAEA 
Safety Fundamentals, thus not imposing a ny additional burden on the Member States' 
authorities.  
EU binding legislation also prov ides legal certainty by opening th e possibility for citizens to 
turn to the European institutions in ca se they feel unsafe about nuclear energy. 
Moreover, it should be mentioned that the new proposal takes fully into account the Member 
States' views expressed during the 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 
supervision solely to the national regulators. 
9.
 MONITORING AND EVALUATION  
The indicators of progress towards meeting the objectives will be set up at the level of the 
Member States. 
10. CONCLUSION  
In the framework of the above considerations , the chosen policy option appears to be the 
preferred approach, as it presents the highest  range the technical, ec onomical and security 
benefits, by going beyond the level of principles and actually encouraging Member States to 
define additional sa fety requirements.