Draft proposal for a COUNCIL DIRECTIVE amending Directive 2009/71/EURATOM establishing a Community framework for the nuclear safety of nuclear installations Draft presented under Article 31 Euratom Treaty for the opinion of the European Economic and Social Committee
Date: 2013-06-13
Institutions: European Commission
Subjects: International Atomic Energy Agency, environmental risk prevention, harmonisation of standards, nuclear law, nuclear power station, nuclear safety, occupational safety, radioactive waste, safety standard

EUROPEAN 
COMMISSION 

Brussels, 13.6.2013  
COM(2013) 343 final 

Draft proposal for a 

COUNCIL DIRECTIVE 

amending Directive 2009/71/EURATOM establishing a Community framework for the 
nuclear safety of nuclear installations 

Draft presented under Article 31 Euratom Treaty for the opinion of the European 
Economic and Social Committee 

{SWD(2013) 199 final} 
{SWD(2013) 200 final} 
{SWD(2013) 201 final} 

EN 

   EN 

 
 
 
 
  
 
 
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

1.1. 

General context 

The  accident  at  the  Fukushima  Daiichi  nuclear  power  plant  (NPP)  in  2011  resulted  in 
significant  environmental,  economic  and  social  damage,  and  raised  concerns  about  possible 
health  effects  in  the  affected  population  in  Japan.  Although  triggered  by  an  earthquake  and 
tsunami of an immense magnitude, investigations of the causes of the accident reveal a range 
of foreseeable factors which combined to produce a catastrophic outcome. The analysis of the 
Fukushima nuclear accident reveals quite substantial and recurring technical issues as well as 
persistent  institutional  failures  similar  to  the  ones  from  the  post-accident  evaluations  of  the 
Three Mile Island and Chernobyl nuclear accidents decades ago. This latest nuclear accident 
once again undermined public confidence in the safety of nuclear power; and particularly so 
at a time when the use of nuclear power is being debated as a possible option to meet global 
energy demands in a sustainable manner.  

The Fukushima nuclear accident renewed attention on the paramount importance of ensuring 
the most robust levels of nuclear safety in the EU and worldwide. 

Nuclear energy currently generates close to 30% of all electricity in the EU and about two-
thirds  of  its  low-carbon  electricity.  The  EU  has  132  operating  reactors,  representing  about 
one-third  of  the  437  operating  nuclear  power  reactors  in  the  world.  Many  of  the  EU  NPPs 
were  constructed  already  three  to  four  decades  ago,  and  are  based  on  designs  and  safety 
provisions that were continuously updated since then.  

Nuclear  safety  is  of  the  utmost  importance  to  the  EU  and  its  people.  The  effects  of  nuclear 
accidents do not stop at national borders and can entail potential harmful consequences for the 
health  of  workers  and  citizens  but  also  wide-ranging  economic  implications.  It  is  therefore 
essential  for  society  and  the  economy  to  reduce  the  risk  of  a  nuclear  accident  in  an  EU 
Member  State  by  applying  high  nuclear  safety  standards  and  guaranteeing  a  high  quality  of 
regulatory oversight.  

In  the  aftermath  of  the  Fukushima  nuclear  accident,  the  EU  response  to  the  events  was 
immediate. 

Based upon a mandate from the European Council at its meeting of 24-25 March 20111, the 
European  Commission,  together  with  the  European  Nuclear  Safety  Regulators  Group 
(ENSREG),  launched  EU-wide  comprehensive  risk  &  safety  assessments  of  nuclear  power 
plants ('Stress Tests'). The Stress Tests were defined as a targeted reassessment of the safety 
margins  of  NPPs  in  the  light  of  the  events  in  Fukushima  related  to  extreme  natural  events 
challenging the plants safety functions. All fourteen EU Member States that operate nuclear 
power  plants2  plus  Lithuania3  participated  in  these  assessments.  Switzerland,  Ukraine  and 

1 
2 

3 

European Council Conclusions EUCO 10/1/11  
Belgium,  Bulgaria,  Czech  Republic,  Finland,  France,  Germany,  Hungary,  Netherlands,  Romania, 
Slovak Republic, Slovenia, Spain, Sweden, United Kingdom 
The Ignalina NPP is being decommissioned 

2 

 
 
                                                 
Croatia  participated  fully  in  the  EU  Stress  Tests  and  the  peer  review  process,  while  other 
neighbouring  countries  (e.g.  Turkey,  Belarus  and  Armenia)  that  agreed  to  use  the  same 
methodology,  are  working  within  different  timetables.  Stress  Tests  were  started  in  2011  by 
self-assessments  carried  out  by  nuclear  operators  and  the  preparation  of  national  reports  by 
national regulators. Preliminary findings were presented in a Commission Communication on 
an  Interim  Stress  Tests  Report4  in  November  2011  and  an  extensive  EU-wide  peer  review 
process was carried out from January to April 2012. An overview report was produced by the 
ENSREG Peer Review Board5 and endorsed by ENSREG. In addition, ENSREG also agreed 
on an Action Plan6 to follow up the implementation of the peer review recommendations. In 
October  2012,  the  Commission  issued  a  Communication  on  the  Final  Stress  Tests  Report7. 
Currently, in line with the requirements of the ENSREG Action Plan, National Action Plans8 
associated with post-Fukushima lessons learned and Stress Test peer review recommendations 
have been prepared and were reviewed in terms of contents and status of implementation in 
the  framework  of  a  Workshop  in  April  2013.  The  Summary  Report  of  the  Workshop  is 
intended  to  be  presented  at  the  2013  Second  ENSREG  Conference  on  Nuclear  Safety  in 
Europe9.  Furthermore  in  the  process  of  ensuring  a  proper  follow-up  of  the  Stress  Tests,  the 
Commission will elaborate, in close cooperation with ENSREG, a consolidated report on the 
status of the implementation of the Stress Tests recommendations, envisaged to be issued in 
June 2014 and transmitted to the European Council.  

In  the  legislative  domain,  the  European  Commission  received  a  clear  mandate  from  the 
European Council in March 2011 "to review the existing legal and regulatory framework for 
the safety of nuclear installations" and propose any improvements that may be necessary.  

The European Parliament has also encouraged a legislative review. In the 2011 Resolution on 
energy  infrastructure  priorities  for  2020  and  beyond10,  it  stated  that  "future  legislative 
initiatives  to  set  up  a  common  framework  for  nuclear  safety  are  essential  in  order  to 
continuously improve safety standards in Europe". Furthermore, in the 2011 Resolution on the 
Commission  Work  Programme  201211,  the  Parliament  called  for  "an  urgent  revision  of  the 
Nuclear Safety Directive with a view to its strengthening, namely by taking into account the 
results  of  the  Stress  Tests  implemented  in  the  aftermath  of  the  Fukushima  accident".  More 
recently, in the 2013 Resolution on Stress Tests12, it called on the revision to be "ambitious in 
nature", including major improvements in areas such as "safety procedures and frameworks – 
in  particular  through  the  definition  and  implementation  of  binding  nuclear  safety  standards 
that reflect state-of-the-art practices in the EU in technical, regulatory and operational respects 
– as well as in the role and resources of the nuclear regulatory authorities and, in particular, 
should  boost  the  latter's  independence,  openness  and  transparency,  while  also  strengthening 
monitoring and peer review". 

4 
5 
6 

7 
8 
9 
10 
11 
12 

COM 784 final 
Peer review Report – Stress Tests performed on European nuclear power plants www.ensreg.eu 
ENSREG  Action  Plan  regarding  the  follow-up  of  the  peer-review  of  the  stress  tests  performed  on 
European nuclear power plants 
COM (2012) 571, 04.10.2012 
17 National Action Plans are available on the ENSREG website www.ensreg.eu 
http://www.ensreg.eu/ensreg-conferences 
P7_TA(2011)0318 
P7_TA(2011)0327 
P7_TA(2013)0089 

3 

 
 
                                                 
The  European  Economic  and  Social  Committee  expressed  in  the  2012  Opinion  on  the 
Commission  Communication  on  a  Final  Stress  Tests  Report13  its  support  for  the 
"Commission's intention to undertake an ambitious revision of the Nuclear Safety Directive". 

In  response  to  the  mandate  from  the  European  Council  and  the  calls  from  the  other  EU 
institutions and bodies, the Commission engaged in a comprehensive process of analysis and 
opinion  gathering,  to  identify  the  appropriate  areas  and  mechanisms  for  legislative 
intervention.  This  process  included  an  open  on-line  public  consultation  (December  2011  – 
February 2012), complemented by an extensive dialogue with the stakeholders. 

The 2011 and 2012 Stress Tests Communications contain indications on the potential areas of 
legislative  improvement.  In  this  context,  with  reference  to  the  existing  Council  Directive 
2009/71/Euratom  establishing  a  Community  framework  for  the  nuclear  safety  of  nuclear 
installations14 
latter 
Communication highlights the areas of safety procedures and frameworks, role and means of 
nuclear regulatory authorities, openness and transparency, monitoring and verification.  

to  as  "Nuclear  Safety  Directive"), 

(hereinafter 

referred 

the 

Moreover, the Commission services developed in the course of 2012 an Impact Assessment, 
based on a wide range of information sources and taking into account the post-Fukushima EU 
and international developments in the nuclear domain. 

On this basis, a draft proposal for a Directive amending the Nuclear Safety Directive has been 
developed, benefiting from the input and expertise of the Euratom Treaty Article 31 Group of 
scientific  experts,  as  well  as  an  extensive  consultation  process  with  the  high-level 
representatives of the national nuclear regulatory authorities reunited in ENSREG. 

1.2. 

Grounds and objectives of the proposal 

The current Nuclear Safety Directive has been a key advancement. However, in the spirit of 
nuclear  safety's  philosophy  of  continuous  improvement,  and  thus  with  the  intention  to  take 
account  inter  alia  of  the  lessons  learned  from  the  Fukushima  nuclear  accident  and  of  the 
outcomes of the subsequent Stress Tests, it was necessary to reconsider the sufficiency of the 
existing provisions.  

The Fukushima nuclear accident has shown that well-known lessons learned from accidents 
decades  ago  have  not  been  taken  up  voluntarily  by  parts  of  the  industry  and  not  been 
sufficiently  enforced  by  regulators,  even  in  a  nation  –  Japan  –  that  was  assumed  to  have 
particularly high standards of industrial and nuclear safety. The technical and organisational 
issues arising from the analysis of this accident are therefore relevant for wider consideration. 

In  Europe,  the  Stress  Tests  have  confirmed  that  there  are  continued  differences  between 
Member States in ensuring comprehensive and transparent identification and management of 
key safety issues. Moreover, the Stress Tests clearly showed the benefits of cooperation and 
coordination mechanisms between all parties having responsibilities for nuclear safety, such 
as peer reviews.  

13 
TEN/498 
14  OJ L 172, 2.7.2009 

4 

 
 
                                                 
In  addition,  in  the  course  of  the  public  meetings  held  in  the  framework  of  the  Stress  Tests, 
demands  have  emerged  to  extend  the  assessment  to  emergency  preparedness  and  response 
arrangements. 

The Commission considers it therefore appropriate to amend, strengthen and supplement the 
Nuclear Safety Directive, by combining technical improvements with wider safety issues such 
as governance, transparency and on-site emergency preparedness and response. 

The proposed amendments aim at enhancing  the regulatory framework for nuclear safety in 
the EU, in particular by: 

– 

– 

– 

– 

– 

Strengthening  the  role  and  effective  independence  of  the  national  regulatory 
authorities; 

Enhancing transparency on nuclear safety matters; 

Strengthening  existing  principles,  and  introducing  new  general  nuclear  safety 
objectives  and  requirements,  addressing  specific  technical  issues  across  the 
entire lifecycle of nuclear installations, particularly NPPs; 

Reinforcing  monitoring  and  exchange  of  experiences,  by  establishing  a 
European system of peer reviews; 

Establishing a mechanism for developing EU-wide harmonised nuclear safety 
guidelines. 

1.3. 

Existing EU legislation in the nuclear safety area 

Following the recognition by the Court of Justice of the EU in the Case 29/9915 of the intrinsic 
link  between  radiation  protection  and  nuclear  safety  and,  thus,  of  the  competence  of  the 
Euratom Community to legislate in the area of nuclear safety, the Nuclear Safety Directive is 
the first EU-wide topical legally binding instrument16. The Directive sets up a legally binding 
framework  based  upon  recognised  principles  and  obligations  of  the  main  international 
instruments  available,  namely  the  Convention  on  Nuclear  Safety17  and  the  Safety 
Fundamentals18 established by the International Atomic Energy Agency (IAEA).  

1.4. 

Consistency with other policy areas 

The Euratom nuclear safety legislation, due to the fact that it ultimately aims at ensuring the 
protection of the workers and the general public against the dangers of ionising radiation, is 
mainly linked to the Euratom radiation protection corpus of legislation, whose main pillar is 
the Basic Safety Standards Directive19. It is not possible to achieve the protection of workers 
and  the  general  public  from  the  dangers  of  ionising  radiation  without  controlling  the 
potentially harmful sources of that radiation. 

15 
16 

17 
18 
19 

Judgment of the Court of Justice of 10 December 2002 [2002] ECR I-11221 
Only  two  legally  non-binding  Council  Resolutions  of  22 July 1975  and  18 June 1992  on  the 
technological problems of nuclear safety existed beforehand 
INFCIRC/449 of 5 July 1994 
IAEA Safety Standard Series no SF-1 (2006) 
Council Directive 96/29/Euratom laying down basic safety standards for the protection of the health of 
workers and the general public against the dangers arising from ionising radiation  

5 

 
 
                                                 
Nuclear  safety  is  also  of  paramount  importance  for  the  overall  prevention,  preparedness  for 
and  response  to  disasters  in  the  Member  States.  The  nuclear  safety  directive  is  thus  closely 
linked to the Union Civil Protection Mechanism20 which provides the framework for the EU 
cooperation in this area, including the response to radiological emergencies inside and outside 
the Union. 

2. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENTS 

2.1. 

Consultation of interested parties 

In the period following the Fukushima nuclear accident, the Commission has engaged in an 
extensive  and  transparent  dialogue  process  with  the  various  stakeholders  and  the  public, 
which included launching an open consultation via the Internet, in line with the Commission's 
minimum consultation standards21.  

In  response  to  the  on-line  public  consultation  seeking  views  on  areas  of  reinforcing  the 
existing  Euratom  nuclear  safety  legislative  framework,  contributions  were  received  from 
nuclear  regulatory  authorities,  other  public  authorities,  companies,  non-governmental 
organisations,  as  well  as  individuals.  This  consultation  offers  insights  into  a  large  range  of 
stakeholder opinions. The broad outcome shows that more than 90% of respondents agree on 
the  importance  of  a  Euratom  nuclear  safety  framework,  setting  up  common  rules  for  EU 
Member  States,  whilst  76%  agree  with  the  need  to  reinforce  the  existing  safety  legislative 
framework.  

The  Commission  also  received  both  written  and  meeting-based  contributions  from  various 
individual 
stakeholders,  e.g.  nuclear  regulatory  authorities,  other  public  authorities, 
companies,  industry  associations  and  non-governmental  organisations.  In  addition,  the 
Commission  has  organised  with  ENSREG  conferences  and  public  debates  involving  a  wide 
range  of  stakeholders,  including  non-governmental  organisations,  on  the  process,  the 
intermediate and final results of the Stress Tests22.  

The  European  social  partners  from  the  Electricity  Sectoral  Social  Dialogue  Committee 
industry have also been consulted. In their response, the social partners underline the role of a 
Euratom nuclear safety legislative framework in setting up common rules for Member States.  

A special role was given to ENSREG, which represents a unique focal point of expertise, as it 
reunites  high-level  representatives  of  the  national  competent  nuclear  regulatory  authorities 
from  all  the  EU  Member  States,  nuclear  and  non-nuclear  alike.  A  detailed  contribution  of 
ENSREG was received and taken into account.  

20 

21 
22 

Commission proposal for a Decision of the European Parliament and of the Council on a Union Civil 
Protection  Mechanism  (COM/2011/934  final),  intending  inter  alia  to  replace  Council  Decision 
2007/779 of 8 November 2007 establishing a Community Civil Protection Mechanism (recast). 
COM(2002) 704 final 

For  instance,  the  first  ENSREG  Conference  on  28-29  June  2011,  a  Stakeholders  Conference  on  Peer 
Reviews on 17 January 2012, a Public Debate on Stress Tests and Peer Review Results on 8 May 2012. 
The second ENSREG Conference is scheduled for June 2013. 

6 

 
 
                                                 
Finally, as part of the procedure laid out in the Euratom Treaty, the Commission consulted the 
Article 31 Group of scientific experts. In their opinion, the experts welcomed the Commission 
proposal  for  amending  the  Nuclear  Safety  Directive  and  make  several  suggestions  for 
enhancing the link with radiation protection legislation.  

2.2. 

Impact Assessment 

In  2012,  an  Impact  Assessment  was  developed.  The  document  analyses  the  challenges  of 
ensuring  sufficient  levels  of  nuclear  safety  in  the  EU.  It  defines  the  general  and  specific 
objectives  for  enhancing  the  prevention  and  mitigation  of  nuclear  accidents.  A  number  of 
policy  options  are proposed  and  analysed, ranging  from  maintaining  the current situation to 
more  profound  reforms.  Each  option  has  been  assessed  for  its  estimated  safety,  economic, 
environmental and social impacts. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

3.1. 

Legal Basis 

Any  legislative  amendment  should  build  upon  and  enhance  the  approach  of  the  current 
Nuclear  Safety  Directive.  The  legal  basis  remains  thus  Articles  31  and  32  of  the  Euratom 
Treaty. 

3.2. 

Subsidiarity and proportionality 

The proposal aims at strengthening even further the role and independence of the competent 
regulatory authorities, as it is clear that only strong regulators endowed with all the necessary 
powers  and  independence  guarantees  can  oversee  and  ensure  the  safe  operation  of  nuclear 
installations in the EU. Close cooperation and information-sharing between regulators, taking 
into account the potential cross-border impacts of a nuclear accident, is encouraged.  

Given  the  wide  consequences  of  a  nuclear  accident  and  particularly  the  public  need  for 
information in such a case, an EU-wide approach on transparency issues is essential. This can 
ensure  that,  irrespective  of  state  borders,  the  public  is  properly  informed  on  all  relevant 
nuclear safety matters. The existing provisions of the Directive are amended in this sense. 

In  Europe,  the  Stress  Tests  have  confirmed  that  there  are  not  only  continued  differences 
between the EU Member States in ensuring comprehensive and transparent identification and 
management  of  key  safety  issues,  but  that  also  gaps  remain.  Therefore,  the  Nuclear  Safety 
Directive is strengthened to include a set of shared objectives aiming at harmonising the EU 
approach  to  nuclear  safety.  Moreover,  the  experience  from  the  Fukushima  nuclear  accident 
and the valuable insights coming from the Stress Tests have clearly shown that exchange of 
information and peer-reviews are an essential element to ensure the effective and continuous 
implementation of any safety regime.  

In accordance with the proportionality principle, the proposed legislative action does not go 
beyond  what  is  necessary  to  achieve  the  objectives.  Furthermore,  taking  into  account  the 
different situations in the Member States, a flexible and proportionate approach as regards the 
level of applicability is defined. A mechanism of joint development by the Member States of 

7 

 
 
EU-wide technical guidelines is defined with special regard to the principle of proportionality, 
by using the knowledge and practical experience of the regulatory experts.  

The applicability and the extent of the provisions of the proposal vary according to the type of 
nuclear  installation.  Therefore,  when  implementing  these  provisions,  Member  States  should 
follow a proportionate approach, taking account of the risks from the specific types of nuclear 
installations. 

3.3. 

Legal elements of the proposal 

The  proposal  introduces  new  or  strengthens  the  existing  provisions  of  the  Nuclear  Safety 
Directive with the overall aim of continuously improving nuclear safety and its regulation at 
EU  level.  Specific  information  on  the  main  proposed  amendments  of  the  Nuclear  Safety 
Directive is presented below. 

Objectives 

Article  1  is  complemented  with  a  new  objective  aiming  at  ensuring  the  avoidance  of 
radioactive  releases  during  all  stages  of  the  lifecycle  of  nuclear  installations  (siting,  design, 
construction, commissioning, operation, decommissioning). 

Definitions 

In  Article  3,  new  definitions  are  introduced  corresponding  to  terms  used  in  the  new 
provisions,  such  as  "accident",  "abnormal  event",  "design  basis",  "design  basis  accident", 
"beyond design basis accident", "periodic safety review". These definitions are aligned with 
the international terminology, such as the IAEA Safety Glossary. 

Legislative, regulatory and organisational framework 

Article 4 is amended in order to further clarify the main elements of the national framework. 
For instance, it is specified that the national safety requirements mentioned in Article 4(1)(a) 
should cover all stages of the lifecycle of nuclear installations.  

Competent regulatory authority (effective independence, regulatory role)  

The Nuclear Safety Directive contains only minimal provisions underlying the independence 
of  the  national  competent  regulatory  authority  in  Article  5(2).  These  provisions  are 
strengthened  in  line  with  latest  international  guidance23,  by  defining  strong  and  effective 
benchmark  criteria  and  requirements  to  guarantee  the  effective  independence  of  regulators. 
New  requirements  include  ensuring  effective  independence  in  decision-making,  own 
appropriate  budget  allocations  and  autonomy  in  implementation,  clear  requirements  for  the 
appointment  and  dismissal  of  staff,  avoidance  and  resolution  of  conflicts  of  interests,  and 
staffing levels with the necessary qualifications, experience and expertise. 

The Nuclear Safety Directive enumerates in a general manner the main competencies of the 
competent regulatory authority in Article 5(2). Through the amendment, these provisions are 
further detailed to ensure that regulators possess the appropriate powers to carry out a strong 

23 

e.g. Governmental, Legal and Regulatory Framework for Safety - General safety requirements - IAEA 
safety standards series no. GSR part 1 

8 

 
 
                                                 
regulatory oversight. For this purpose, the core task of the competent regulatory authority to 
define  national  nuclear  safety  requirements  is  added  to  the  existing  catalogue  of  regulatory 
competencies.  

Transparency  

The  existing  provisions  of  Article  8  of  the  Nuclear  Safety  Directive  are  limited  to  generic 
requirements on public information. Moreover, this Article does not impose any obligation on 
the licence holder, who has the prime responsibility for nuclear safety. To fill these gaps, in 
the proposed amendment, the existing provisions are extended and specified. Thus, both the 
competent regulatory authority and the licence holder are required to develop a transparency 
strategy,  which  covers  information  provision  under  normal  operating  conditions  of  nuclear 
installations as well as communication in case of accident or abnormal event conditions. The 
role of the public is fully acknowledged through the requirement that it effectively participates 
in the licensing process of nuclear installations. Recently organised exchanges with experts24 
in the field have confirmed that the public has a very important role to play by being involved 
effectively  in  the  decision-making  procedures  and  that  their  views  should  be  considered, 
taking into account the provisions of the Aarhus Convention25.  

Nuclear Safety Objectives  

The current Nuclear Safety Directive does not include specific requirements for the different 
stages of the lifecycle of nuclear installations. Therefore, for example the type of risks related 
to  the  issues  identified  in  the  analysis  of  the  Fukushima  accident  and  the  subsequent  Stress 
Tests are not sufficiently identified and addressed by the provisions of the current Directive, 
e.g.:  

• 

• 

• 

The  need  to  evaluate  the  appropriateness  of  the  siting  of  nuclear  installations 
based on considerations on how to prevent, where possible, and minimise the 
impact from external hazards; 

The  need  to  continuously  re-assess  the  probability  of  such  hazards  and  their 
impacts in the course of periodic safety reviews and perform a corresponding 
design basis review for each nuclear installation, including for the purpose of 
possible lifetime extension; 

The  need  to  base  risk  assessments,  including  those  for  external  events,  on 
methods reflecting progress in scientific development and thus enable effective 
continuous improvement of safety.  

In  line  with  the  principle  of  continuous  improvement  of  nuclear  safety  the  amendment 
introduces  general  safety  objectives  for  nuclear  installations  (Article  8a)  which  reflect  the 
progress achieved at the level of WENRA in developing safety objectives for new NPPs.  

24 

25 

Series  of  international  workshops  between  2009-2013  with  the  participation  of  DG  ENER,  DG  ENV 
from the Commission side and National Association of Committees and Commission of Information - 
French “Local Commissions of Information” (CLIs) and their national federation (ANCCLI)  
Convention on  access  to  information,  public  participation  in  decision-making  and  access  to  justice  in 
environmental matters, ratified on 17 February 2005 by Council Decision 2005/370/EC 

9 

 
 
                                                 
For achieving these  high level safety objectives,  more  detailed  provisions  are  laid  down  for 
different life-cycle phases of nuclear installations (Article 8b).  

In addition, in order to support their consistent implementation, methodological requirements 
concerning  the  siting,  design,  construction,  commissioning,  operation  and  decommissioning 
of nuclear installations, are laid out in Article 8c. 

This  approach  provides  flexibility  to  the  national  frameworks,  by  assigning  high  level 
objectives  that  have  to  be  fulfilled  by  national  legislation  in  line  with  the  principle  of 
continuous  improvement  of  nuclear  safety.  For  example,  this  leaves  to  Member  States  the 
choice  of  selecting  among  the  available  engineering  solutions  to  upgrade  their  nuclear 
installations  when  addressing  safety  issues  based  on  lessons  learned  from  severe  accidents, 
such as the need to allow safe depressurizing of a reactor containment in case of an accident 
(e.g. by means of containment filtered venting).  

On-site emergency preparedness and response 

The amendment includes provisions regarding on-site emergency preparedness and response 
as  the  current  Directive  does  not  provide  for  such  measures.  The  new  provisions  include 
indications  on  the  planning  and  organisational  measures  that  should  be  provided  by  the 
licence  holder  (Article  8d).  As  an  example  of  new  requirements,  the  amendment  prescribes 
that  an  on-site  emergency  response  centre  is  required  for  a  nuclear  installation,  sufficiently 
protected against the effects from external events and severe accidents, including radiological 
ones, and equipped with the necessary material to mitigate the effects of severe accidents.  

Peer Reviews 

The existing provisions of the Nuclear Safety Directive of Article 9(3) include a requirement 
for  periodic  self-assessment  of  the  Member  States  national  framework  and  competent 
regulators authorities, combined with the obligation to invite an international peer review on 
relevant segments. This concept remains unchanged in the proposal, in Article 8e(1). 

The  amendment  introduces  new  provisions  on  self-assessments  and  peer-reviews  of  nuclear 
installations based on nuclear safety topics selected by the Member States jointly and in close 
coordination with the Commission across the entire lifecycle of nuclear installations (example 
could  be  the  above-mentioned  containment  depressurisation  in  case  of  severe  accident  in 
order  to  avoid  hydrogen  explosion).  Should  Member  States  fail  to  jointly  select  at  least  a 
topic,  the  European  Commission  should  select  the  topics  to  be  subject  to  the  peer  reviews. 
Further,  each  Member  State  has  to  define  a  methodology  for  the  implementation  of  the 
technical  recommendations  from  the  peer  review  process.  Should  the  Commission  identify 
substantial deviations or delays in the implementation of the technical recommendations from 
the peer review process, the Commission should invite the competent regulatory authorities of 
Member  States  not  concerned  to  organise  and  carry  out  a  verification  mission  to  get  a  full 
picture  of  the  situation  and  inform  the  Member  State  concerned  about  possible  measures  to 
remedy any identified shortcomings. 

In case of an accident with off-site consequences, a special peer review should be arranged.  

This new compulsory and regular mechanism of EU peer reviews (Article 8e(2) to (5)) aims 
at verifying the level of technical compliance with the safety objectives in each Member State. 

10 

 
 
These  new  provisions  setting  out  the  peer-review  mechanism  are  without  prejudice  to  the 
rules governing the infringement procedure in case a Member State fails to fulfil an obligation 
under the Treaties, as laid out in Articles 258, 259 and 260 of the Treaty on the Functioning of 
the European Union (TFEU). 

Proportionate implementation of the amended Directive 

The  amendment  acknowledges  that  the  applicability  and  the  extent  of  the  provisions  of  the 
amended  Directive  vary  according  to  the  type  of  nuclear  installation.  Therefore,  when 
implementing  these  provisions,  Member  States  should  follow  a  proportionate  approach, 
taking  account  of  the  risks  posed  by  the  specific  types  of  nuclear  installations  they  plan  or 
operate. 

Reporting on practical implementation of the amended directive 

The provisions of the Nuclear Safety Directive on reporting are not changed by this proposal, 
leaving  the  date  for  the  first  reporting  on  22  July  2014  at  which  the  Member  States  are 
expected to submit a report on the implementation of the existing provisions of the Directive. 
At  the  time  of  the  second  reporting  on  the  implementation  however,  by  22  July  2017,  the 
Member  States  should  report  on  the  implementation  of  the  Nuclear  Safety  Directive  as 
amended by this proposal. 

4. 

BUDGETARY IMPLICATION  

The proposal has no budgetary implications for the EU budget. 

5. 

EXPLANATORY DOCUMENTS 

In accordance with the Joint Political Declaration of Member States and the Commission on 
explanatory  documents  of  28  September  2011,  Member  States  have  undertaken  to 
accompany,  in  justified  cases,  the  notification  of  their  transposition  measures  with  one  or 
more  documents  explaining  the  relationship  between  the  components  of  a  directive  and  the 
corresponding parts of national transposition instruments. 

With regard to this Directive, the Commission considers the transmission of such documents 
to be justified for the following reasons: 

• 

The complexity of the transposition of the amended Nuclear Safety Directive at 
national level 

The existing provisions of the Nuclear Safety Directive are significantly strengthened by this 
proposal which also introduces new substantial provisions in several areas. The complexity of 
transposition of the amended directive is therefore determined by the fact that is covers many 
different issues, including requirements on national framework for nuclear safety of nuclear 
installations,  role  and  independence  of  national  regulatory  authorities,  obligations  of  the 
licence  holders,  skills  in  nuclear  safety,  transparency  on  nuclear  safety  matters,  technical 
objectives  and  requirements  on  nuclear  safety  of  nuclear  installations,  on-site  emergency 
preparedness and response and provisions on national assessments of nuclear installations and 

11 

 
 
related  topical  peer-reviews.  Moreover,  the  directive  places  requirements  on  different 
Member States' bodies as well as private actors. 

The  different  obligations  inherent  to  the  amended  directive  are  therefore  likely  to  lead  to  a 
complex  transposition  at  national  level.  The  existing  provisions  of  the  Nuclear  Safety 
Directive have already been transposed in general by several national transposition measures 
per Member State, the number is however exceeding 15 transposition measures in some cases. 
The number of notified transposition measures can be legitimately expected to rise with the 
new  provisions  brought  to  the  existing  directive  by  this  proposal.  Furthermore,  due  to  the 
specificity  of  nuclear  safety,  various  transposition  measures  are  used  and  notified  to  the 
Commission,  ranging  from  laws,  government  decrees  and  ministerial  orders  to  instructions 
and decisions of national nuclear regulatory authorities.  

The need for explanatory documents explaining the relationship between the provisions of the 
amended  Nuclear  Safety  Directive  and  the  corresponding  parts  of  national  transposition 
measures seems to be obvious under these circumstances. 

• 

Pre-existing national legislation  

In  some  Member  States,  some  legislation  is  already  in  place  in  the  area  of  amendments 
brought  by  this  proposal.  The  transposition  of  the  amended  Directive  is  therefore  likely  to 
result  in  a  combination  of  amendments  to  existing  national  legislation  and  adoption  of  new 
legislation.  In  such  a  situation,  the  explanatory  documents  would  be  necessary  to  obtain  a 
clear and comprehensive picture of the transposition. 

• 

Framework directive 

The  proposed  amendments  do  not  fundamentally  change  the  'framework'  character  of  the 
Nuclear Safety Directive. The amended directive continues to include general principles and 
requirements. 

It is important for the Commission and its monitoring of transposition and implementation to 
know  which  national  provisions  transpose  the  general  principles  and  requirements  that  the 
amended directive lays down. For instance, the proposal introduces general safety objectives 
and  requirements  for  all  types  of  nuclear  installations.  Given  the  very  broad  scope  of  these 
new  safety  objectives  and  requirements,  it  is  of  utmost  importance  for  the  Commission  but 
also the public to be able to ascertain how they are transposed at national level. 

PROPORTIONALITY PRINCIPLE 

The  requirement  to  provide  explanatory  documents  can  create  an  additional  administrative 
burden  on  the  Member  States.  This  burden  is  however  not  disproportionate  considering  the 
objectives of the amended Nuclear Safety Directive and the complexity of its subject matter. 
It  is  furthermore  necessary  for  the  Commission  to  allow  effective  verification  of  correct 
transposition.  There  are  no  less  burdensome  measures  to  allow  efficient  verification, 
considering the likely complexity of transposition at national level which may result in new or 
amended legislation. It is also to be mentioned that a relevant number of Member States have 
already been notifying useful explanatory documents to the Commission on their transposition 
of  the  existing  Euratom  legislation  such  as  the  existing  Nuclear  Safety  Directive  or  other 
pieces of legislation. 

12 

 
 
Draft proposal for a 

COUNCIL DIRECTIVE 

amending Directive 2009/71/EURATOM establishing a Community framework for the 
nuclear safety of nuclear installations 

Draft presented under Article 31 Euratom Treaty for the opinion of the European 
Economic and Social Committee 

THE COUNCIL OF THE EUROPEAN UNION, 

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

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

Having regard to the opinion of the European Parliament,  

Having regard to the opinion of the European Economic and Social Committee,  

Whereas: 

(1) 

(2) 

(3) 

Article  2(b)  of  the  Treaty  establishing  the  European  Atomic  Energy  Community 
('Euratom  Treaty')  provides  for  the  establishment  of  uniform  safety  standards  to 
protect the health of workers and of the general public. 

Article  30  of  the  Euratom  Treaty  provides  for  the  establishment  of  basic  standards 
within  the  European Atomic Energy Community ('Community') for the protection of 
the health of workers and the general public against the dangers arising from ionizing 
radiations. 

Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards 
for the protection of the health of workers and the general public against the dangers 
arising from ionizing radiation1 establishes the basic safety standards. This Directive 
establishes requirements for a system of radiation protection including the justification 
and  optimisation  of  radiation  exposures  and  dose-limitation  for  public  and 
occupational exposure. It specifies requirements for the control of radiation exposures 
to the public and to workers under both normal operations and emergency situations. 
The provisions of Directive 96/29/Euratom have been supplemented by more specific 
legislation. 

1 

OJ L 159, 29.6.1996, p. 1. 

13 

 
 
 
 
                                                 
(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

2 
3 
4 
5 
6 

7 
8 

9 
10 

The  Court  of  Justice  of  the  European  Union  has  recognised  in  its  case-law2  that  the 
Community shares competences, together with its Member States, in fields covered by 
the Convention on Nuclear Safety3. 

Council  Directive  2009/71/Euratom  of  25  June  2009  establishing  a  Community 
framework  for  the nuclear  safety of  nuclear installations4 imposes obligations on the 
Member States to establish and maintain a national framework for nuclear safety. That 
Directive  reflects  the  provisions  of  the  main  international  instruments  in  the  field, 
namely the Convention on Nuclear Safety5 and the Safety Fundamentals6 established 
by the International Atomic Energy Agency ('IAEA'). The deadline for Member States 
to bring into force and notify the Commission the laws, regulations and administrative 
procedures to comply with, Directive 2009/71/Euratom expired on 22 July 2011. 

Council  Directive  2011/70/Euratom  of  19  July  2011  establishing  a  Community 
framework  for  the  responsible  and  safe  management  of  spent  fuel  and  radioactive 
waste7 imposes obligations on the Member States to establish and maintain a national 
framework for spent fuel and radioactive waste management. 

Council Conclusions of 8 May 2007 on nuclear safety and safe management of spent 
nuclear  fuel  and  radioactive  waste8  highlighted  that  “nuclear  safety  is  a  national 
responsibility exercised where appropriate in an EU-framework. Decisions concerning 
safety  actions  and  the  supervision  of  nuclear  installations  remain  solely  with  the 
operators and national authorities”. 

Following up on the Council’s invitation to set up a High Level Group at EU level, as 
recorded  in  its  above  mentioned  Conclusions  of  8  May  2007,  the  European  Nuclear 
Safety  Regulators  Group  (ENSREG)  was  established  by  Commission  Decision 
2007/530/Euratom of 17 July 2007 on establishing the European High Level Group on 
Nuclear  Safety  and  Waste  Management9  to  contribute  to  the  achievement  of  the 
Community objectives in the field of nuclear safety. 

The Fukushima nuclear accident in Japan in 2011 renewed attention worldwide on the 
measures needed to minimise risk and ensure the most robust levels of nuclear safety. 
Based  on  a  mandate  from  the  European  Council  in  March  201110,  the  Commission, 
together with the European Nuclear Safety Regulator Group ('ENSREG'), carried out 
Union wide comprehensive risk and safety assessments of nuclear power plants ('stress 

C-187/87 (1988 ECR p. 5013), C-376/90 (1992 ECR I-6153) and C-29/99 (2002 ECR I-11221). 
OJ L 172, 6.5.2004, p. 7.  
OJ L 172, 2.7.2009. p. 18. 
OJ L 318, 11.12.1999, p. 20. 
IAEA  Safety  Fundamentals:  Fundamental  safety  principles,  IAEA  Safety  Standard  Series  No  SF-1 
(2006). 
OJ L 199, 2.8.2011. p. 48. 
Adopted by the Coreper on 25 April 2007 (doc. Ref. 8784/07) and the Economic and Financial Affairs 
Council on 8 May 2007. 
OJ L 195, 27.7.2007, p. 44. 
European Council, EUCO 10/1/11.  

14 

 
 
                                                 
tests'). The results identified a number of improvements which could be implemented 
in nuclear safety approaches and industry practices in the participating countries11. 

(10)  Moreover, the European Council also mandated the Commission to review the existing 
legal and regulatory framework for the safety of nuclear installations and propose any 
improvements  that  may  be  necessary.  The  European  Council  also  stressed  that  the 
highest  standards  for  nuclear  safety  should  be  implemented  and  continuously 
improved in the EU. 

(11)  The Commission included initial views on potential areas of legislative improvement 
in  its  Communication  on  the  Interim  Report  on  the  Comprehensive  Risk  and  Safety 
Assessments  ("stress  tests")  of  Nuclear  Power  Plants  in  the  European  Union12  of  24 
November 2011.  

(12) 

In line with its general principles of consultation and dialogue, the Commission also 
conducted an on-line public consultation, between December 2011 and February 2012, 
seeking views on areas of reinforcing the Community nuclear safety framework. 

(13)  The  Commission  identified  a  number  of  areas  for  revising  the  current  Directive 
2009/71/Euratom,  as  outlined  in  its  4  October  2012  Communication  from  the 
Commission to the Council  and  the European Parliament on the comprehensive risk 
and safety assessments ("stress-tests") of nuclear power plants in the EU and related 
activities13. 

(14) 

In identifying the relevant areas for improvement, the Commission took into account 
technical  progress  achieved  at  European  and  international  level,  the  experience  and 
results  gained  from  the  stress  tests,  the  findings  of  the  various  reports  into  the 
Fukushima nuclear accident, the views expressed in the public consultation on areas of 
reinforcing  the  Community  legislative  framework,  the  views  expressed  by  different 
stakeholders  including  national  competent  regulatory  authorities,  industry  and  civil 
society, and the results of the preliminary assessment of the transposing measures of 
the Member States. 

(15)  A  strong  and  independent  competent  regulatory  authority  is  a  fundamental  condition 
of  the  European  nuclear  safety  regulatory  framework.  Its  independence  and  the 
exercise of its powers impartially and transparently are crucial factors to ensure a high 
level of nuclear safety. Objective regulatory decisions and enforcement actions should 
be  established  without  any  undue  external  influence  that  might  compromise  safety, 
such as pressures associated with changing political, economic or societal conditions, 
or pressures from government departments or any other public or private entities. The 
negative  consequences  of  the  lack  of  independence  were  evident  in  the  Fukushima 
accident.  The  provisions  of  Directive  2009/71/Euratom  on  functional  separation  of 
competent  regulatory  authorities  should  be  strengthened  to  ensure  the  regulatory 
authorities'  effective  independence  and  to  guarantee  that  they  are  provided  with  the 
appropriate means and competencies to properly carry out the responsibilities assigned 

11 

12 
13 

ENSREG  Peer  review  Report  –  Stress  Tests  performed  on  European  nuclear  power  plants,  25  April 
2012. 
COM(2011) 784 final. 
COM (2012) 571 final. 

15 

 
 
                                                 
to  them.  In  particular,  the  regulatory  authority  should  have  sufficient  legal  powers, 
sufficient  staffing  and  sufficient  financial  resources  for  the  proper  discharge  of  its 
assigned  responsibilities.  The  strengthened  requirements  aiming  at  ensuring 
independence in carrying out the regulatory tasks should be however without prejudice 
to  close  cooperation,  as  appropriate,  with  other  relevant  national  authorities  or  to 
general  policy  guidelines  issued  by  the  government  not  related  to  the  regulatory 
powers and duties. 

(16)  The independence of the regulatory authority's decision making further depends on the 
competence  of  its  staff.  Therefore  the  regulatory  authority  should  employ  staff  with 
the  necessary  qualifications,  experience  and  expertise  to  be  able  to  undertake  its 
functions and responsibilities. Given the specialised nature of the nuclear industry and 
the  limited  availability  of  persons  with  the  required  expertise  and  competence, 
resulting in the possible rotation of persons with executive responsibility between the 
nuclear  industry  and  the  regulators,  special  attention  should  be  given  to  avoiding 
conflicts of interest. Moreover, arrangements should be made to ensure that there is no 
conflict of interest for those organisations that provide the regulatory body with advice 
or services.  

(17)  When undertaking infrastructure projects that could affect the nuclear safety of nuclear 
installations,  the  appropriate  national  mechanisms  of  consultation  with  national 
regulatory  authorities  and  the  public  should  be  in  place  and  full  account  should  be 
taken of the opinions expressed by them. 

(18)  Directive  2011/92/EU  on  the  assessment  of  the  effects  of  certain  public  and  private 
projects  on  the  environment14  is  relevant  for  nuclear  installations.  This  Directive 
provides  that  the  Member  States  must  ensure  that,  before  development  consent  is 
given,  projects  likely  to  have  significant  effects  on  the  environment  by  virtue,  inter 
alia,  of  their  nature,  size  or  location  are  made  subject  to  an  assessment  of  the 
environmental  effects.  In  this  regard,  it  is  a  tool  for  ensuring  that  environmental 
considerations are integrated in the licensing process of nuclear installations. 

(19)  Any  assessment  under 

this  Directive 

is  without  prejudice 

to  any  relevant 

environmental assessment. 

(20)  For  nuclear  installations  for  which  the  obligation  to  carry  out  assessments  of  the 
effects on the environment arises simultaneously from this Directive and other Union 
legislation, Member States may provide for coordinated or joint procedures fulfilling 
the requirements of the relevant Union legislation. 

(21)  The  consequences  of  a  nuclear  accident  can  go  beyond  national  borders,  therefore 
close  cooperation,  coordination  and  information  exchange  between  regulatory 
authorities of neighbouring countries or of countries in the same region, irrespective of 
whether  they  operate  nuclear  installations  or  not,  need  to  be  encouraged.  In  this 
respect,  Member  States  should  ensure  that  appropriate  arrangements  are  in  place  to 
facilitate  such  cooperation  on  nuclear  safety  matters  with  cross-border  impacts, 
including  with  third  countries.  Synergies  should  be  sought  with  the  Union  Civil 

14 

OJ L 26, 28.01.2012, p.1 - codified version of Directive 85/337/EEC on the assessment of the effects of 
certain public and private projects on the environment, as amended. 

16 

 
 
                                                 
Protection  Mechanism15  which  provides  an  EU  framework  for  cooperation  between 
the  Member  States  in  the  field  of  civil  protection  in  improving  the  effectiveness  of 
systems  for  preventing,  preparing  for  and  responding  to  natural  and  man-made 
disasters. 

(22) 

In  order  to  ensure  that  the  proper  skills  are  acquired  and  that  adequate  levels  of 
competence  are  achieved  and  maintained,  all  parties  should  ensure  that  all  staff 
(including  sub-contractors),  having  responsibilities  relating  to  the  nuclear  safety  of 
nuclear  installations  and  to  the  on-site  emergency  preparedness  and  response 
arrangements,  undergo  a  continuous  learning  process.  This  can  be  achieved  through 
the establishment of training programmes and training plans, procedures for periodic 
review  and  updating  of  the  training  programmes  as  well  as  appropriate  budgetary 
provisions for training. 

(23)  Another key lesson learned from the Fukushima nuclear accident is the importance of 
enhancing  transparency  on  nuclear  safety  matters.  Transparency  is  also  an  important 
means to promote independence in regulatory decision making. Therefore, the current 
provisions  of  Directive  2009/71/Euratom  on  the  information  to  be  provided  to  the 
public should be more specific as to which type of information should be provided, as 
a  minimum  by  the  competent  regulatory  authority  and  by  the  licence  holder,  and 
within which time frames. To this purpose, for example, the type of information that 
should be provided, as a minimum by the competent regulatory authority and by the 
licence  holder  as  part  of  their  wider  transparency  strategies,  should  be  identified. 
Information  should  be  released  in  a  timely  manner,  particularly  in  case  of  abnormal 
events and accidents. Results of periodic safety reviews and international peer reviews 
should also be made public.  

(24)  The requirements of this Directive on transparency are complementary to those of the 
existing Euratom legislation. Council Decision 87/600/Euratom of 14 December 1987 
on Community arrangements  for  the  early exchange of information in the event of a 
radiological emergency16 imposes obligations on Member States to notify and provide 
information to the Commission and to other Member States in case of a radiological 
emergency on its territory, whilst Council Directive 89/618 Euratom of 27 November 
198917  includes  requirements  on  Member  States  to  inform  the  public  about  health 
protection measures to be applied and steps to be taken in the event of a radiological 
emergency,  and  to  provide  advance  and  continuing  information  to  the  population 
likely to be affected in the event of a such an emergency. However, in addition to the 
information  to  be  provided  in  such  an  event,  Member  States  should  under  this 
Directive arrange for appropriate  transparency provisions,  with  prompt  and regularly 
updated release of information to ensure that workers and the general public are kept 
informed about all nuclear safety related events, including abnormal events or accident 
conditions.  Moreover,  the  public  should  be  given  opportunities  to  participate 
effectively  in  the  licencing  process  of  nuclear  installations  and  the  competent 
regulatory  authority  should  provide  any  safety-related  information  independently, 
without need for prior consent from any other public or private entity.  

15 

16 
17 

Commission proposal for a Decision of the European Parliament and of the Council on a Union Civil 
Protection Mechanism (COM/2011/934 final). 
OJ L 371, 30.12.1987, p. 76. 
OJ L 357, 7.12.1989, p.31. 

17 

 
 
                                                 
(25)  The  Directive  2009/71/Euratom  sets  up  a  legally  binding  Community  framework 
underlying  a  nuclear  safety  legislative,  administrative  and  organisational  system.  It 
does  not  include  specific  requirements  for  nuclear  installations.  In  view  of  the 
technical  progress  achieved  by  the  IAEA,  and  the  Western  European  Nuclear 
Regulators  Association  ('WENRA')  and  other  sources  of  expertise,  including  the 
lessons 
the  Fukushima  nuclear  accident 
tests  and 
investigations, Directive 2009/71/Euratom should be amended to include Community 
nuclear  safety  objectives  covering  all  stages  of  the  lifecycle  of  nuclear  installations 
(siting, design, construction, commissioning, operation, decommissioning). 

learned  from 

the  stress 

(26)  Risk-informed  methods  examine  the  probability  of  each  event  in  an  event  sequence 
likely  to  lead  or  contribute  to  an  accident  as  well  as  its  possible  consequences.  The 
answers  can  be  used  to  provide  insights  into  the  strengths  and  weaknesses  of  the 
design  and  operation  of  a  nuclear  installation  and  can  thus  guide  requirements  and 
regulatory attention to the issues where the largest benefit for the safety of a nuclear 
installation  can  be  obtained.  Having  invested  over  the  last  decades  considerable 
resources  in  developing  Probabilistic  Safety  Assessments  for  nuclear  installations, 
particularly  for  nuclear  power  plants  and  research  reactors,  licence  holders  and 
competent  regulatory  authorities  worldwide  are  now  in  a  position  to  use  the  insights 
derived  to  enhance  the  safety  of  nuclear  installations  on  a  risk-informed  basis  while 
operating them in the most efficient manner. 

(27)  Ageing  of  the  safety  related  structures,  systems  and  components  of  a  nuclear 
installation, and especially embrittlement of components which are difficult to replace 
in  practice,  such  as  reactor  pressure  vessels,  puts  a  natural  limit  to  its  acceptable 
continued operation. From both a safety and an economical point of view, the limit of 
operational  lifetime  is  typically  40  years  after  the  start  of  commercial  operation 
therefore  Member  States  should  ensure  that  possible  lifetime  extension  of  existing 
nuclear  power  plants  does  not  expose  the  workers  and  the  public  to  additional  risks. 
To  this  end,  Directive  2009/71/Euratom  should  be  amended  to  include  new 
Community  wide  safety  objectives  to  be  complied  with  by  the  regulatory  authorities 
and the licence holders in case of a lifetime extension of existing nuclear power plants. 

(28)  For  new  reactor  design,  there  is  a  clear  expectation  to  address  in  the  original  design 
what  was  beyond  design  for  previous  generations  of  reactors.  Design  extension 
conditions  are  accident  conditions  that  are  not  considered  for  design  basis  accidents, 
but  are  considered  in  the  design  process  of  the  installation  in  accordance  with  best 
estimate methodology, and for which releases of radioactive material are kept within 
acceptable  limits.  Design  extension  conditions  could  include  severe  accident 
conditions. 

(29)  Application  of  the  concept  of  defence-in-depth  in  organisational,  behavioural,  or 
design activities related to a nuclear installation, ensures that safety related activities 
are subject to independent layers of provisions, such that if a failure were to occur, it 
would  be  detected  and  compensated  by  appropriate  measures.  The  independent 
effectiveness of each of the different layers is an essential element of defence in depth 
to prevent accidents and mitigate the consequences if they do occur. 

(30)  After  the  nuclear  accidents  at  Three  Mile  Island  and  Chernobyl,  the  Fukushima 
nuclear  accident  highlighted  once  again  the  critical  importance  of  the  containment 

18 

 
 
function,  which  is  the  last  barrier  to  protect  people  and  the  environment  against 
radioactive  releases  resulting  from  an  accident.  Therefore  the  applicant  for  a  licence 
for  the  construction  of  a  new  power  or  research  reactor  should  demonstrate  that  the 
design  practically  limits  the  effects  of  a  reactor  core  damage  to  within  the 
containment, i.e. he has to prove that a radioactive release outside the containment is 
physically impossible or can be considered extremely unlikely with a high degree of 
confidence for such release to occur. 

(31)  Directive  2009/71/Euratom  does  not  include  measures  regarding  on-site  emergency 
preparedness and response, which, as the Fukushima nuclear accident highlighted, are 
crucial  to  mitigate  the  consequences  of  a  nuclear  accident.  Council  Directive 
96/29/Euratom  foresees  that,  in  case  of  radiological  emergencies,  it  is  necessary  to 
organise appropriate intervention to stop or reduce the emission of radionuclides, and 
to assess and  record the consequences of the emergency and the effectiveness of the 
intervention. Measures should also be in place for the protection and monitoring of the 
environment  and  population.  However,  more  specific  provisions  regarding  on-site 
emergency  preparedness  and  response  are  needed  in  order  to  assess  situations  that 
might  require  on-site  protective  measures,  to  have  an  organisational  structure  and 
coordination  among  response  bodies,  and  to  ensure  that  sufficient  resources  are 
available to apply those appropriate protective measures even in extreme cases. 

(32)  The stress tests demonstrated the key role of enhanced cooperation and coordination 
mechanisms  between  all  parties  having  responsibilities  for  nuclear  safety.  The  peer-
reviews  have  proved  to  be  a  good  means  of  building  confidence,  with  the  aim  of 
developing and exchanging experience and ensuring the common application of high 
nuclear safety standards. The scope of the provisions of Directive 2009/71/Euratom is 
however  limited  only  to  self-assessments  and  international  peer-reviews  of  Member 
States'  legislative,  regulatory  and  organisational  infrastructure  and  therefore  the 
Directive should be widened to include peer reviews of nuclear installations. 

(33)  This  Directive  introduces  new  provisions  on  self-assessments  and  peer-reviews  of 
nuclear  installations  based  on  selected  nuclear  safety  topics  covering  their  entire 
lifecycle.  At  an  international  level,  there  is  already  confirmed  experience  with 
conducting such peer-reviews on nuclear power plants. At the EU level, the experience 
from the stress tests process shows the value of a coordinated exercise to assess and 
review  the  safety  of  EU  nuclear  power  plants.  A  similar  mechanism,  based  on 
cooperation  between  the  Member  States'  regulatory  authorities  and  the  Commission, 
should be applied here. Therefore, competent regulatory authorities coordinating in the 
context  of  expert  groups  such  as  ENSREG,  could  contribute  with  their  expertise  to 
identifying  the  relevant  safety  topics  and  in  carrying  out  these  peer  reviews.  If 
Member  States  fail  to  jointly  select  at  least  one  topic  the  Commission  should  select 
one  or  more  topics  to  be  subject  to  the  peer  reviews.  Participation  of  other 
stakeholders, such as Technical Support Organisations, international observers or non-
governmental Organisations could bring added value to the peer reviews.  

(34) 

In order to guarantee the rigour and the objectivity of the peer reviews, Member States 
should  provide  access  to  all  necessary  information,  subject  to  the  required  security 
clearance procedures, to staff and to the nuclear installation concerned.  

19 

 
 
(35)  An appropriate follow-up mechanism should be established to ensure that the outcome 
of these peer-reviews is properly implemented. Peer reviews should help improve the 
safety  of  individual  nuclear  installations  as  well  as  help  formulate  generic  technical 
safety recommendations and guidelines valid across the Union. 

(36) 

the  Commission 

identifies  substantial  deviations  or  delays 

In  case 
the 
implementation  of  the  technical  recommendations  from  the  peer  review  process,  the 
Commission should invite the competent regulatory authorities of Member States not 
concerned  to  organise  and  carry  out  a  verification  mission  with  the  aim  of  getting  a 
full picture of the situation and informing the Member State concerned about possible 
measures to remedy any identified shortcomings. 

in 

(37)  The  provisions  setting  out  the  peer-review  mechanism  of  this  Directive  are  without 
prejudice to the rules governing the procedure in case a Member State fails to fulfil an 
obligation under the Treaties, as laid out in Articles 258, 259 and 260 of the Treaty on 
the Functioning of the European Union (TFEU). 

(38)  The  periodicity  of  the  peer  reviews  and  the  reporting  under  this  Directive  should  be 

aligned with the review and reporting cycles of the Convention on Nuclear Safety. 

(39) 

In  line  with  the  principle  of  proportionality,  the  applicability  of  the  provisions  of 
Chapter  2,  Section  2  "Specific  Obligations"  of  this  Directive  depends  on  the  type  of 
nuclear installations on the territory of a Member State. Therefore, when implementing 
these provisions in national law, Member States should take account of the risks posed 
by  the  specific  types  of  nuclear  installations  they  plan  or  operate.  In  particular,  the 
proportionality  principle  will  concern  those  Member  States  that  keep  only  a  small 
inventory of nuclear and radioactive materials, e.g. linked to the operation of smaller 
research  reactor  facilities,  which  in  case  of  a  severe  accident  would  not  engender 
consequences comparable to those generated by nuclear power plants. 

(40)  The  provisions  of  this  Directive  which  are  intrinsically  linked  to  the  existence  of 
nuclear installations, namely those concerning the licence holder's obligations, the new 
specific  requirements  for  nuclear  installations  and  the  provisions  concerning  the  on-
site  emergency  preparedness  and  response  are  not  applicable  to  Member  States 
without nuclear installations as defined by this Directive. These Member States need 
not transpose and implement the requirement to impose penalties on those who do not 
comply  with  this  Directive.  The  other  provisions  of  this  Directive  should  be 
transposed  and  implemented  in  a  proportionate  manner  in  accordance  with  national 
circumstances and taking into account the fact that these Member States do not have 
nuclear installations, whilst ensuring that nuclear safety receives appropriate attention 
by the government or by the competent authorities. 

(41)  According  to  Directive  2009/71/Euratom,  the  Member  States  have  to  establish  and 
maintain  a  national  legislative,  regulatory  and  organisational  framework  ('national 
framework') for nuclear safety of nuclear installations. The determination on how the 
provisions of the national framework are adopted and through which instrument they 
are applied rests with the competence of the Member States. 

(42) 

In  accordance  with  the  Joint  Political  Declaration  of  Member  States  and  the 
Commission  on  explanatory  documents  of  28  September  2011,  Member  States  have 

20 

 
 
undertaken  to  accompany,  in  justified  cases,  the  notification  of  their  transposition 
measures  with  one  or  more  documents  explaining  the  relationship  between  the 
provisions  of  a  directive  and  the  corresponding  parts  of  national  transposition 
instruments. With regard to this Directive, the legislator considers the transmission of 
such documents to be justified. 

(43)  Directive 2009/71/Euratom should therefore be amended accordingly, 

HAS ADOPTED THIS DIRECTIVE: 

Article 1 

Directive 2009/71/Euratom is amended as follows: 

(1) 

The heading of Chapter 1 is replaced by the following:  

"OBJECTIVES, SCOPE OF APPLICATION AND DEFINITIONS". 

(2) 

In Article 1, the following point (c) is added: 

"(c) to ensure that Member States shall provide for appropriate national arrangements 
so that nuclear installations are designed, sited, constructed, commissioned, operated 
or decommissioned so as to avoid unauthorised radioactive releases." 

(3) 

Article 2 is amended as follows: 

(a)  paragraph 1 is replaced by the following: 

"1. This Directive shall apply to any civilian nuclear installation subject to a licence 
as defined in Article 3(4) at all stages covered by this licence.";  

(b)  paragraph 3 is replaced by the following: 

(4) 

"6. 

"3.  This  Directive  supplements  the  basic  standards  referred  to  in  Article  30  of  the 
Treaty as regards the nuclear safety of nuclear installations and is without prejudice 
to the existing Community legislation for the protection of the health of the workers 
and  the  general  public  against  the  dangers  arising  from  ionising  radiation,  and  in 
particular Directive 96/29/Euratom.".  

In Article 3, the following paragraphs 6 to 17 are added: 

‘defence-in-depth’  means  a  hierarchical  deployment  of  different  levels  of  diverse 
equipment  and  procedures  to  prevent  the  escalation  of  anticipated  operational 
occurrences and to maintain the effectiveness of physical barriers placed between a 
radiation  source  or  radioactive  material  and  workers,  members  of  the  public  or  the 
air,  the  water  and  the  soil,  in  operational  states  and,  for  some  barriers,  in  accident 
conditions; 

21 

 
 
7. 
‘abnormal  event’  means  any  unintended  occurrence  the  consequences,  or 
potential  consequences  of  which  are  not  negligible  from  the  point  of  view  of 
protection or nuclear safety;  

'accident'  means  any  unplanned  event,  including  operating  errors,  equipment 
8. 
failures and other mishaps, the consequences or potential consequences of which are 
not negligible from the point of view of protection or nuclear safety; 

'early  releases'  means  situations  that  would  require  off-site  emergency 

9. 
measures but with insufficient time to implement them;  

'large releases' means situations that would require protective measures for the 

10. 
public that could not be limited in area or time; 

11. 
'practically  eliminating'  means  that  it  is  physically  impossible  or  it  can  be 
considered  extremely  unlikely  with  a  high  degree  of  confidence  for  a  condition  to 
occur; 

12. 
'reasonably achievable' means that, in addition to meeting the requirements of 
good practice in engineering, further safety or risk reduction measures for the design, 
commissioning,  operation  or  decommissioning  of  a  nuclear  installation  should  be 
sought and that these measures should be implemented unless it can be demonstrated 
that  they  are  grossly  disproportionate  with  regard  to  the  safety  benefit  they  would 
confer; 

13. 
'design  basis'  means  the  range  of  conditions  and  events  taken  explicitly  into 
account in the design of an installation, according to established criteria, so that the 
installation  can  withstand  them  without  exceeding  authorised  limits  by  the  planned 
operation of safety systems; 

14. 
'design basis accident' means accident conditions against which an installation 
is  designed  according  to  established  criteria,  and  for  which  the  damage  to  the  fuel 
and the release of radioactive material are kept within authorised limits; 

'beyond  design  basis  accident'  means  an  accident  which  is  possible,  but  was 

15. 
not fully considered in the design because it was judged to be too unlikely; 

16. 
'design extension analysis' means a set of design extension conditions derived 
on  the  basis  of  engineering  judgement,  deterministic  assessments  and  probabilistic 
assessments  for  the  purpose  of  further  improving  the  safety  of  the  nuclear  power 
plant  by  enhancing  the  plant’s  capabilities  to  withstand,  without  unacceptable 
radiological  consequences,  accidents  that  are  either  more  severe  than  design  basis 
accidents  or  that  involve  additional  failures.  These  design  extension  conditions  are 
used to identify the additional accident scenarios to be addressed in the design and to 
plan practicable provisions for the prevention of such accidents or the mitigation of 
their consequences if they do occur. 

17. 
'periodic  safety  review'  means  a  systematic  reassessment  of  the  safety  of  an 
existing installation carried out at regular intervals to deal with the cumulative effects 
of  ageing,  modifications,  operating  experience,  technical  developments  and  siting 

22 

 
 
aspects and aimed at ensuring a high level of safety throughout the service life of the 
installation.". 

(5) 

In Chapter 2, the following title is inserted after the heading ‘OBLIGATIONS’: 

"SECTION 1 

General obligations".  

(6) 

Article 4, paragraph 1 is amended as follows: 

(a) 

the introductory part is replaced by the following: 

"1. Member States shall establish and maintain a national legislative, regulatory 
and  organisational  framework  (hereinafter  referred  to  as  the  ‘national 
framework’)  for  nuclear  safety  of  nuclear 
that  allocates 
responsibilities  and  provides  for  coordination  between  relevant  state  bodies. 
The national framework shall provide in particular for:"; 

installations 

(b)  point (a) is replaced by the following: 

national  nuclear  safety  arrangements,  covering  all  stages  of  the 

"(a) 
lifecycle of nuclear installations referred to in Article 3(4);";  

(c)  point (b) is replaced by the following: 

a  system  of  licensing  and  prohibition  of  operation  of  nuclear 

"(b) 
installations without a licence;"; 

(d)  point (c) is replaced by the following: 

"(c) 

a system of nuclear safety supervision;". 

(7) 

In Article 5, paragraphs 2 and 3 are replaced by the following: 

"2.  Member  States  shall  guarantee  the  effective  independence  of  the  competent 
regulatory authority from undue influence in its decision making, in particular when 
carrying  out  the  regulatory  tasks  set  out  in  paragraph  3,  ensuring  that  safety  is  not 
subordinated  to  political,  economic  or  societal  interests.  For  this  purpose,  Member 
States shall ensure that the national framework requires that the competent regulatory 
authority: 

(a) is functionally separate from any other public or private entity concerned with the 
promotion or utilisation of nuclear energy or electricity production; 

(b)  does  not  seek  or  take  instructions  from  any  other  public  or  private  entity 
concerned  with  the  promotion  or  utilisation  of  nuclear  energy  or  electricity 
production, when carrying out its regulatory tasks; 

(c)  takes  regulatory  decisions,  founded  on  objective  and  verifiable  safety-related 
criteria; 

23 

 
 
(d) has its own appropriate budget allocations, with autonomy in the implementation 
of the allocated budget. The financing mechanism and the budget allocation process 
shall be clearly defined in the national framework; 

(e)  employs  an  appropriate  number  of  staff  with  the  necessary  qualifications, 
experience and expertise; 

(f) establishes procedures and criteria for the appointment and dismissal of staff, and 
for the prevention and resolution of any conflicts of interest; 

(g)  provides  safety-related  information  without  review  or  clearance  from  any  other 
public or private entity in accordance with Article 8(2). 

3.  Member States shall ensure that the competent regulatory authority is given the 
legal  powers  necessary  to  fulfil  its  obligations  in  connection  with  the  national 
framework  described  in  Article  4(1)  with  due  priority  to  safety.  For  this  purpose, 
Member  States  shall  ensure  that  the  national  framework  provides  for  the  following 
main regulatory tasks: 

(a) 

to define national nuclear safety requirements;  

to  require  the  licence  holder  to  comply  with  national  nuclear  safety 

(b) 
requirements and the terms of the relevant licence; 

to require demonstration of this compliance, including the requirements under 

(c) 
paragraphs 2 to 5 of Article 6 and Articles 8a to 8d;  

(d) 

to verify this compliance through regulatory assessments and inspections; 

(e) 
to  carry  out  enforcement  actions,  including  suspending  the  operation  of  a 
nuclear  installation  in  accordance  with  the  conditions  defined  by  the  national 
framework referred to in Article 4(1).". 

(8) 

Article 6 is amended as follows: 

(a) paragraph 1 is replaced by the following: 

"1.  Member States shall ensure that the national framework requires that the prime 
responsibility  for  the  nuclear  safety  of  a  nuclear  installation  rests  with  the  licence 
holder. This responsibility cannot be delegated."; 

(b) paragraph 2 is replaced by the following: 

"2. Member States shall ensure that the national framework requires licence holders, 
under the supervision of the competent regulatory authority, to regularly assess and 
verify, and continuously improve, as far as reasonably achievable, the nuclear safety 
of their nuclear installations in a systematic and verifiable manner.";  

(c) paragraph 3 is replaced by the following:  

24 

 
 
"3.  The  assessments  referred  to  in  paragraph  2  shall  include  verification  that, 
based  on  a  comprehensive  safety  assessment,  measures  are  in  place  for  the 
prevention  of  accidents  and  mitigation  of  the  consequences  of  accidents,  including 
verification of the sufficiency of defence-in-depth provisions and the licence holders' 
organisational measures of protection that would have to fail before workers and the 
general public would be significantly affected by ionising radiations."; 

(d) paragraph 4 is replaced by the following: 

"4.  Member  States  shall  ensure  that  the  national  framework  requires  licence 
holders to establish and implement management systems which give due priority to 
nuclear safety and are regularly verified by the competent regulatory authority."; 

(e) the following paragraph 4a is inserted: 

"4a.  Member  States  shall  ensure  that  the  national  framework  requires  that  when 
applying for a licence, the applicant is required to submit a detailed demonstration of 
safety.  Its  scope  and  level  of  detail  shall  be  commensurate  with  the  potential 
magnitude and nature of the hazard presented. It shall be reviewed and assessed by 
the competent regulatory authority in accordance with clearly defined procedures."; 

(f) paragraph 5 is replaced by the following: 

"5.  Member  States  shall  ensure  that  the  national  framework  requires  licence 
holders  to  provide  for  and  maintain  adequate  financial  and  human  resources,  with 
appropriate qualifications, expertise and skills, to fulfil their obligations with respect 
to  nuclear  safety  of  a  nuclear  installation,  laid  down  in  paragraphs  1  to  4a  of  this 
Article  and  Articles  8a  to  8d  of  this  Directive.  These  obligations  also  extend  to 
subcontracted workers.". 

(9) 

Articles 7 and 8 are replaced by the following: 

"Article 7 

Expertise and skills in nuclear safety 

Member States shall ensure that the national framework requires all parties to make 
arrangements  for  education, 
their  staff  having 
responsibilities  relating  to  the  nuclear  safety  of  nuclear  installations  and  to  on-site 
emergency  preparedness  and  response  arrangements,  in  order  to  build  up,  maintain 
and  to  further  develop  up-to-date  and  mutually  recognised  expertise  and  skills  in 
nuclear safety.  

training  and  exercise  for 

Article 8 

Transparency 

1.  Member  States  shall  ensure  that  up  to  date  and  timely  information  in  relation  to 
nuclear safety of nuclear installations and related risks is made available to workers 
and the general public, with specific consideration to those living in the vicinity of a 
nuclear installation. 

25 

 
 
The  obligation  established  in  the  first  subparagraph  includes  ensuring  that  the 
competent  regulatory  authority  and  the  licence  holders,  within  their  fields  of 
responsibility,  develop,  publish  and  implement  a  transparency  strategy  covering, 
inter  alia,  information  on  normal  operating conditions  of  nuclear  installations,  non-
mandatory  consultation  activities  with  the  workers  and  the  general  public  and 
communication in case of abnormal events and accidents. 

2.  Information  shall  be  made  available  to  the  public  in  accordance  with  applicable 
Union and national legislation and international obligations, provided that this does 
not  jeopardise  other  overriding  interests,  such  as  security,  recognised  in  national 
legislation or international obligations. 

3.  Member  States  shall  ensure  that  the  public  shall  be  given  early  and  effective 
opportunities  to  participate  in  the  licensing  process  of  nuclear  installations,  in 
accordance  with  relevant  Union  and  national 
international 
obligations.".  

legislation  and 

(10) 

The following Section 2 is inserted after Article 8: 

"SECTION 2 

Specific obligations 

Article 8a 

Safety objective for nuclear installations 

1.  Member  States  shall  ensure  that  the  national  framework  requires  that  nuclear 
installations  are  designed,  sited,  constructed,  commissioned,  operated  and 
decommissioned with the objective of avoiding potential radioactive releases by: 

(a)  practically  eliminating  the  occurrence  of  all  accident  sequences  which  would 

lead to early or large releases; 

(b) 

for  accidents  that  have  not  been  practically  eliminated,  implementing  design 
measures so that only limited protective measures in area and time are needed 
for the public and that sufficient time is available to implement these measures, 
and that the frequency of such accidents is minimised. 

2. Member States shall ensure that the national framework requires that the objective 
set out in paragraph 1 applies to existing nuclear installations to the extent reasonably 
achievable. 

Article 8b 

Implementation of the safety objective for nuclear installations 

In  order  to  achieve  the  safety  objective  set  out  in  Article  8a,  Member  States  shall 
ensure that the national framework requires that nuclear installations are: 

26 

 
 
sited  so  that  due  consideration  is  provided  to  avoid,  where  possible, 

(a) 
external natural and man-made hazards and minimise their impact; 

designed,  constructed,  commissioned,  operated  and  decommissioned 

(b) 
based on the defence-in-depth concept so that: 

(i)  radiation  doses  to  workers  and  the  general  public  do  not  exceed 
prescribed limits and are kept as low as reasonably achievable; 

(ii) the occurrence of abnormal events is minimised; 

(iii)  the  potential  for  escalation  to  accident  situations  is  reduced  by 
enhancing the nuclear installations’ capability to effectively manage and 
control abnormal events; 

(iv)  harmful  consequences  of  abnormal  events  and  design  basis 
accidents, should they occur, are mitigated to ensure that they induce no 
off-site radiological impact, or only minor radiological impact; 

(v) external natural and man-made hazards are avoided, where possible, 
and their impact is minimised. 

Article 8c 

Methodology for siting, design, construction, commissioning, operation and 
decommissioning of nuclear installations 

1. Member States shall ensure that the national framework requires that the licence 
holder, under the supervision of the competent regulatory authority: 

(a) 

regularly evaluates the radiological impact of a nuclear installation on workers, 
the general public and air, water and soil, in both normal operating and in both 
operating and accident conditions; 

(b)  defines,  documents  and  re-assesses  regularly  and  at  least  every  ten  years,  the 
design  basis  of  nuclear  installations  through  a  periodic  safety  review,  and 
supplements  it  by  a  design  extension  analysis,  to  ensure  that  all  reasonably 
practicable improvement measures are implemented; 

(c) 

(d) 

(e) 

ensures  that  the  design  extension  analysis  covers  all  accidents,  events  and 
combination  of  events,  including  internal  and  external  natural  or  man-made 
hazards and severe accidents, leading to conditions not included in the design 
basis accidents; 

establishes and implements strategies to mitigate both design basis and beyond-
design basis accidents; 

implements  Severe  Accident  Management  Guidelines  for  all  nuclear  power 
plants  and,  if  appropriate,  other  nuclear  installations,  covering  all  operational 
conditions, accidents in the spent fuel pools and long-duration events; 

27 

 
 
(f) 

carries  out  a  specific  safety  review  for  nuclear  installations  which  the 
competent  regulatory  authority  considers  to  be  close  to  the  limit  of  their 
operating  lifetime  as  originally  foreseen,  and  for  which  an  extension  of  the 
lifetime is requested. 

2. Member States shall ensure that the national framework requires that the granting 
or the review of a licence to construct and/or operate a nuclear installation should be 
based upon an appropriate site- and installation-specific safety assessment. 

3.  Member  States  shall  ensure  that  the  national  framework  requires,  for  nuclear 
power  plants  and,  if  applicable,  for  research  reactor  facilities,  for  which  a 
construction  licence  is  sought  for  the  first  time,  that  the  competent  regulatory 
authority  obliges  the  applicant  to  demonstrate  that  the  design  practically  limits  the 
effects of a reactor core damage to within the containment.  

Article 8d 

On-site emergency preparedness and response 

Member  States  shall  ensure  that  the  national  framework  requires  that  the  licence 
holder, under the supervision of the competent regulatory authority: 

(a)  prepares and regularly updates an on-site emergency plan which shall: 

(i)  be  based  on  an  assessment  of  events  and  situations  that  may  require 

protective measures on-site or off-site; 

(ii)  be  co-ordinated  with  all  other  bodies  involved  and  shall  draw  on  lessons 
learned from the feedback of experience from severe events, should they 
occur; 

(iii)  address  in  particular  events  that  could  impact  multiple  units  of  a  nuclear 

installation; 

(b) 

establishes  the  necessary  organisational  structure  for  clear  allocation  of 
responsibilities and ensures the availability of necessary resources and assets; 

(c)  puts in place arrangements for co-ordinating on-site activities and co-operating 
with  authorities  and  agencies  responsible  for  emergency  response  throughout 
all phases of an emergency, that should be regularly exercised; 

(d)  provides  for  preparedness  measures  for  the  workers  on-site  with  regard  to 

potential abnormal events and accidents; 

(e)  provides  arrangements  for  cross-border  and 

international  cooperation, 
including pre-defined arrangements for receiving on-site external assistance, if 
needed; 

(f) 

arranges  for  an  on-site  emergency  response  centre,  sufficiently  protected 
against natural hazards and radioactivity to ensure its habitability; 

28 

 
 
(g) 

takes  protective  measures  in  case  of  an  emergency  in  order  to  mitigate  any 
consequences for human health and for air, water and soil.". 

(11) 

The following Chapter 2a is inserted after Chapter 2: 

"CHAPTER 2a 

PEER REVIEWS AND GUIDELINES 

Article 8e 

Peer Reviews 

1. Member States shall at least every ten years arrange for periodic self-assessments 
of  their  national  framework  and  competent  regulatory  authorities  and  invite  an 
international  peer  review  of  relevant  segments  of  their  national  framework  and 
competent  regulatory  authorities  with  the  aim  of  continuously  improving  nuclear 
safety. Outcomes of any peer review shall be reported to the Member States and the 
Commission, when available. 

2.  Member  States,  with  the  support  of  the  competent  regulatory  authorities,  shall 
periodically  arrange,  and  at  least  every  six  years,  a  system  of  topical  peer  reviews 
and  agree  on  a  time-frame  and  the  modalities  for  implementation.  For  this  purpose 
Member States shall: 

(a) 

jointly  and  in  close  coordination  with  the  Commission  select  one  or  more 
specific  topics  related  to  the  nuclear  safety  of  nuclear  installations.  Should 
Member  States  fail  to  jointly  select  at  least  a  topic  within  the  time  frame 
specified  in  this  paragraph,  the  Commission  shall  select  the  topics  to  be  the 
subject of the peer reviews; 

(b)  based  on  these  topics,  perform  in  close  collaboration  with  licence  holders, 

national assessments and publish the results; 

(c) 

jointly define a methodology, arrange and carry out a peer review of the results 
of the national assessments referred to in point (b), to which the Commission is 
invited to participate; 

(d)  publish the results of the peer reviews referred to in point (c). 

3.  Each  Member  State  subject  to  the  peer  review  referred  to  in  paragraph  2  shall 
arrange  for  the  planning  and  mode  of  implementation  on  its  territory  of  relevant 
technical recommendations resulting from the peer-review process and shall inform 
the Commission thereof. 

4.  Should  the  Commission  identify  substantial  deviations  or  delays  in  the 
implementation  of  the  technical  recommendations  resulting  from  the  peer  review 
process, the Commission shall invite the competent regulatory authorities of Member 
States  not  concerned  to  organise  and  carry  out  a  verification  mission  to  get  a  full 
picture  of  the  situation  and  inform  the  Member  State  concerned  about  possible 
measures to remedy any identified shortcomings. 

29 

 
 
5. In case of an accident which leads to an early or large release or an abnormal event 
leading  to  situations  that  would  require  off-site  emergency  measures  or  protecting 
measures for the public, the Member State concerned shall invite within six months a 
peer  review  of  the  installation  concerned  in  accordance  with  paragraph  2,  and  to 
which the Commission shall be invited to participate. 

Article 8f 
Guidelines for the improvement of nuclear safety 

Based on the results of the peer reviews performed in accordance with Article 8e(2) 
and  the  resulting  technical  recommendations,  in  line  with  the  principles  of 
transparency  and  continuous  improvement  of  nuclear  safety,  Member  States  shall, 
with  the  support  of  the  competent  regulatory  authorities,  jointly  develop  and 
establish guidelines on the specific topics referred to in Article 8e(2)(a).". 

(12) 

The following title is inserted after Chapter 2a:  

"CHAPTER 2b 

GENERAL PROVISIONS". 

(13) 

In Article 9, paragraph 3 is deleted. 

(14) 

The following Article 9a is inserted after Article 9: 

"Article 9a 
Penalties 

The Member States shall lay down the rules on penalties applicable to infringements 
of  the  national  provisions  adopted  pursuant  to  this  Directive  and  shall  take  all 
measures necessary to ensure that they are implemented. The penalties provided for 
must  be  effective,  proportionate  and  dissuasive.  The  Member  States  shall  notify 
those provisions to the Commission by [insert date –this date must correspond to the 
deadline for transposition set out in article 2 of this proposal] at the latest and shall 
notify it without delay of any subsequent amendment affecting them.". 

(15) 

In Article 10, the following paragraph 1a is inserted after paragraph 1: 

"1a. The obligations of transposition and implementation of Articles 6, 8a, 8b, 8c, 8d 
and 9a of this Directive shall not apply to Cyprus, Ireland, Luxembourg and Malta, 
unless they decide to develop any activity related to nuclear installations subject to a 
licence under their jurisdiction.". 

Article 2 

1. 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 
provisions necessary to comply with this Directive by [deadline for transposition to 
be inserted in the course of the legislative process] at the latest. They shall forthwith 
communicate to the Commission the text of those provisions. 

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

2. 

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

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

Article 3 

Article 4 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the Council 
The President 

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