REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT on the progress made with the implementation of Directive 2009/71/Euratom establishing a Community framework for the safety of nuclear installations amended by Directive 2014/87/Euratom
Date: 2022-04-21
Institutions: Directorate-General for Energy, European Commission
Subjects: access to information, application of EU law, exchange of information, nuclear law, nuclear policy, nuclear power station, nuclear safety, professional qualifications

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 21.4.2022  COM(2022) 173 final  REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT on the progress made with the implementation of Directive 2009/71/Euratom establishing a Community framework for the safety of nuclear installations amended by Directive 2014/87/Euratom {SWD(2022) 107 final}  
 
 
I.  

INTRODUCTION  

Council  Directive  2009/71/Euratom  establishing  a  Community  framework  for  the  safety  of 
nuclear  installations1  was  a  major  step  towards  achieving  a  legally  binding  nuclear  safety 
framework within the European Union.  

In the aftermath of the 2011 Fukushima nuclear accident, Council Directive 2014/87/Euratom 
amending  Council  Directive  2009/71/Euratom2  (the  2009  Directive,  as  amended  in  2014,  is 
hereinafter referred to as ‘Directive’) strengthened the EU nuclear safety legal framework in 
response  to  a  mandate  given  by  the  European  Council3.  It  consolidated  existing  provisions 
and  introduced  new  requirements,  focusing  on  regulatory  independence  and  an  EU-wide 
high-level nuclear safety objective aiming at:  

-  Strengthening  the  powers  and  independence  of  the  competent  regulatory 
authorities4,  for  instance  through  provisions  on  adequate  human  and  financial 
resources or prevention and resolution of conflicts of interest. 

-  Preventing accidents and, should accidents occur, mitigating their consequences and 

avoiding early and large radioactive releases. 

In addition, the amendments also cover: 

- 

Increasing transparency by providing public information from regulatory authorities 
and licence holders5 on normal operating conditions,  on incidents and accidents, and 
enhancing cooperation between regulators. 

-  Providing opportunities for public participation in the decision-making related to the 

licensing of nuclear installations. 

- 

Implementing the nuclear safety objective through defence-in-depth and measures to 
promote and enhance an effective nuclear safety culture. 

-  Performing  an  initial  installation-specific  assessment,  supplemented  by  Periodic 

Safety Reviews (PSRs), at least every ten years. 

-  Enacting  specific  requirements  for  accident  management  and  on-site  emergency 

preparedness and response (EP&R). 

-  Setting  up  a  European  system  of  Topical  Peer  Reviews  (TPR)  carried  out  at  least 

every six years.  

The  Directive  required  Member  States  to  submit  to  the  Commission  the  second  and  final 
round of national reports by 22 July 2020; all Member States complied with this obligation by 

1   OJ  L  172,  2.7.2009,  p.  18–22.  The  Nuclear  Safety  Directive  was  adopted  under  Chapter  3  “Health  and 
Safety” of the Euratom Treaty, aiming to contribute to the protection of the health of workers and the general 
public against the dangers arising from ionising radiations. 

2   Council Directive of 8 July 2014 amending Directive 2009/71/Euratom establishing a Community framework 

for the nuclear safety of nuclear installations, OJ L 219, 25.7.2014, p. 42–52. 

3   European Council Conclusions (24/25 March 2011), EUCO 10 1/11. 

4   Referred to in the report as ‘regulatory authorities’ or ‘regulators’. 

5   Referred to in the report as ‘licensees’. 

1 

 
 
                                                 
the  end  of  20206.  This  second  progress  report  to  the  Council  and  European  Parliament  is 
adopted by the Commission pursuant to Article 9(2) of the Directive. 

This  second  progress  report7,  more  than  ten  years  after  the  Fukushima  nuclear  accident, 
acknowledges  the  advances  made  by  the  Member  States  with  the  implementation  of  the 
Directive.  At  the  same  time,  it  identifies  areas  where  the  step  change  in  the  regulatory 
framework  and  practice,  envisaged  by  the  Directive,  has  not  yet  been  fully  accomplished. 
Further  improvements  in  these  areas  are  desirable  and  in  this  respect  the  current  report 
presents a number of observations addressed to Member States (sections II and III on nuclear 
safety  governance  and  safety  of  nuclear  installations,  respectively),  resulting  from  the  good 
practices  and  challenges  identified  in  the  evaluation  and  corresponding  to  the  Directive’s 
thematic  areas8,  with  due  consideration  of  national  specificities9.  Taking  account  of  these 
observations, the report makes specific key recommendations (section IV on conclusions and 
way  forward)  where  there  is  scope  for  future  action  at  EU  level  to  continuously  improve 
nuclear safety in the EU. 

The  report  relies  primarily  on  the  Commission  services’  assessment  of  the  2020  national 
reports. However, to ensure a broad picture of nuclear safety in the EU, the report also takes 
into  account  additional  sources,  particularly  the  national  measures  taken  by  the  Member 
States  to  transpose  the  Directive;  the  outcomes  of  the  comprehensive  risk  and  safety 
assessments (‘EU Stress Tests’) of nuclear power plants (NPPs) in the EU10 and of the first 
TPR11; the findings of international peer-reviews; issues raised by EU citizens and other EU 
institutions through complaints, petitions and questions; findings of commissioned studies.  

A Staff Working Document accompanies and supports the report. It specifies in more details 
the  thematic  assessments  of  the  national  approaches  carried  out  (and  synthesised  in  the 
Report) and  gives an overview of the types  of nuclear installations, as reported by  Member 
States. 

II.  NUCLEAR SAFETY GOVERNANCE (Articles 4, 5, 7 and 8 of the Directive) 

2.1.  LEGISLATIVE,  REGULATORY  AND  ORGANISATIONAL  FRAMEWORK 

(Article 4)  

All Member States have in place national frameworks to carry out the activities covered by 
the  Directive,  whose  scope  and  level  of  detail  vary  significantly  depending  on  the  national 
nuclear profiles.  

6   https://ec.europa.eu/energy/topics/nuclear-energy/nuclear-safety_en 

7   The  first  Commission  progress  report  on  the  implementation  of  the  2009  Directive  was  issued  in  2015 

(COM/2015/0573 final). 

8   The numbering of the articles from the consolidated version of the Nuclear Safety Directive (2009 Directive 

as modified in 2014) is used throughout the report. 

9   Concerning Member States without nuclear installations, considering that the obligations of transposition and 
implementation of Articles 6, 8a, 8b, 8c and 8d of the Directive do not apply to them, the information on the 
above articles, if voluntarily included in their reports, was not reflected in the overall evaluation. 

10   http://www.ensreg.eu/EU-Stress-Tests 

11   https://www.ensreg.eu/eu-topical-peer-reviews 

2 

 
 
 
                                                 
A review of the allocation of responsibilities reveals that while a single regulatory authority 
concentrates  the  nuclear  safety  competencies  in  the  majority  of  Member  States,  in  some 
others  core  regulatory  competences  (rule-making,  licensing,  assessment,  inspection  and 
enforcement)  are  shared  by  more  than  one  entity.  Moreover,  the  regulators  work  in 
coordination with ministries and other authorities, as well as cooperate with regional or local 
authorities.  However,  the  clear  allocation  of  nuclear  safety  responsibilities  between  the 
different national bodies is not entirely evident in some national reports. 

The  Member  States  have  national  nuclear  safety  requirements,  either  self-standing  or 
linked to radiation protection provisions. In most cases, these requirements are incorporated in 
legally  binding 
(e.g. 
recommendations,  guidelines)  usually  play  a  role  in  providing  additional  detail  and 
implementation  guidance.  Generally,  these  requirements  address  all  lifecycle  stages  of  the 
nuclear installations as required by the Directive. 

subsequent  non-legally  binding 

acts,  while 

instruments 

All Member States have licensing systems in place, and the operation of nuclear installations 
without a licence is prohibited. The licensing processes vary between countries, with the main 
differences  concerning  the  role  of  the  regulatory  authority,  the  types  of  documents  required 
for the application and the lifecycle stages covered by the licence(s). Procedures for licence 
modifications and renewals are also described. 

The  Member  States  have  systems  of  regulatory  control,  performed  by  the  regulatory 
authorities  on  a  continuous  basis,  supported  by  procedures,  strategies,  plans,  and  follow-up 
arrangements.  This  monitoring  is  supported  by  enforcement  mechanisms  addressing 
identified breaches. In addition to regulators, other law enforcement bodies may be involved. 
As regards sanctions, most Member States follow a graded approach, ranging from issuing a 
warning  to  the  suspension  or  revocation  of  the  licence  or  even  fines  or  criminal  sanctions, 
depending on the severity of the breach.  

Observations  

  Where several authorities are involved in the implementation and enforcement of the 
Directive’s  requirements,  a  clear,  streamlined  and  well-documented  allocation  of 
responsibilities  would  enhance  clarity  on  how  the  tasks  are  divided  to  avoid  any 
omissions or undue duplications. 

  Strengthened  collaboration  amongst  regulatory  authorities  on  licensing  practices, 
while not explicitly required by the Directive, could bring benefits to all by identifying 
potential commonalities to promote consistency and best use of resources. 

2.2.  COMPETENT REGULATORY AUTHORITY (Article 5) 

A  strong  regulatory  authority  with  effective  independence  from  undue  influence  in  the 
regulatory decision-making is a fundamental requirement for achieving a high level of nuclear 
safety.  The  Directive  requires  that  regulatory  independence  is  ensured  through  functional 
separation,  absence  of  external  instructions,  robust  and  transparent  decisions,  appropriate 
financial and human resources, and avoidance of conflicts of interest. 

The  legal  status  and  structure  of  the  regulatory  authorities  differ  among  Member  States, 
with  three  main  organisational  schemes  being  identified,  namely  regulators  as  independent 
authorities with  legal  personality and  reporting channels  to  the Government/President/Prime 
Minister;  regulators as independent  authorities supervised by a Ministry  not  concerned with 
the promotion or utilisation of nuclear energy; and regulators as integral parts of a Ministry 

3 

 
 
not concerned with the promotion or utilisation of nuclear energy, having a precise mandate 
and distinct responsibilities. It follows from the above that those Member States that opted for 
the  first  scheme  saw  the  benefits  not  only  of  functional  separation,  but  also  of  legal 
separation from any other government structure. 

The  absence  of  instructions  either  results  from  express  prohibitions  in  this  sense  or, 
implicitly, from the overall regulatory architecture. 

The regulatory decisions are based on nuclear safety provisions that incorporate international 
and  European  requirements,  as  well  as  lessons  from  operating  experience.  Transparency  is 
ensured  through  a  wide  array  of  communication  tools,  such  as  websites;  annual  activity 
reports; publications of safety-related documents, such as regulatory decisions and inspection 
reports; social media; press releases; meetings with stakeholders, including local authorities, 
and public consultations. 

On  the  regulators’  financial  resources,  two  main  financing  models  are  identified,  either 
relying on state budget or on a combination of budgetary funds and recovery of incurred costs 
from  operators.  The  involvement  of  the  regulators  occurs,  mainly,  during  the  phase  of 
planning of needs and in the autonomous implementation of the allotted funds. The majority 
of  the  Member  States  rely  on  the  general  national  budgetary  procedures.  Possibilities  of 
requesting  additional  resources  or  flexibility  clauses  are  sometimes  specified.  Transparency 
on  the  budget’s  expenditure,  through  publication  of  annual  reports  or  audit  conclusions,  is 
reported  in  some  cases.  However,  only  a  few  Member  States  lay  down  specific  provisions 
requiring that the allocated financial resources are appropriate to fulfil the regulatory duties. 
Further follow-up on this issue is therefore needed to ensure effective implementation of the 
Directive’s provisions. 

With  regard  to  the  regulators’  human  resources,  regulators  generally  play  a  key  role  in 
evaluating  their  own  needs  and,  if  necessary,  requesting  additional  resources.  Concerning 
staff  qualifications,  several  common  trends  could  be  identified,  such  as  education  and 
expertise conditions upon recruitment, initial training for newcomers, and continuous training 
through a combination of in-house and external sources. Commonly, outside expertise is used 
to support regulatory decisions. Several Member States highlight difficulties in attracting and 
maintaining  sufficient  and/or  qualified  staff.  Similarly  to  the  financial  resources,  the 
requirements that regulators should have a sufficient number of staff, adequately qualified and 
trained, could be better specified in some Member States and their implementation therefore 
warrants  further  follow  up.  Promoting  an  increased  attractiveness  of  the  employment 
conditions  at  the  regulatory  authorities  could  improve  the  situation  in  recruiting  and 
maintaining staff with adequate qualifications and expertise.  

The  Member  States  have,  in  general,  rules  on  the  prevention  and  resolution  of  conflicts  of 
interest  included  in  the  general  framework  measures  for  all  civil  servants.  Although  many 
Member  States  adopted  more  specific  requirements  applicable  to  the  regulatory  authorities, 
the legal force and level of detail of these requirements varies. In particular, the situations of 
the  rotation  of  staff  with  executive  responsibility  between  the  nuclear  industry  and  the 
regulators,  and  the  use  of  external  expertise  are  often  not  specifically  addressed  by  the 
dedicated rules.  

The dissemination of nuclear safety-related information by the regulatory authorities without 
clearance from other bodies is either explicitly spelled out in the national legislation or it can 
be inferred from the institutional setup. 

4 

 
 
Concerning their main regulatory tasks, the regulators are involved, to a different extent, in 
the formulation of national nuclear safety requirements, depending on the architecture of the 
national  legal  system.  The  regulators  are  responsible  for  overseeing  the  implementation  of 
these  requirements  on  the  ground  by  exercising  their  powers  to  perform  regulatory 
assessments and take enforcement actions. 

Observations   

  Regulatory authorities as self-standing legal entities, legally separated from any other 
public  or  private  bodies,  where  not  yet  the  case,  would  represent  a  further  step  in 
strengthening regulatory independence. 

  Specific legal provisions requiring that adequate and dedicated financial and human 
resources (for the latter, both in terms of numbers and qualifications) are available to 
regulators,  supported  by  effective  mechanisms,  criteria  and  procedures,  would 
enhance their regulatory capacities. Such measures could be further strengthened by 
flexibility mechanisms allowing the regulators to receive additional resources in cases 
of supplementary workload or due to unforeseen circumstances, such as responses to 
nuclear safety events or to non-nuclear emergencies. 

  Clear  legal  requirements  defining  the  conditions,  procedures  and  reasons  for  the 
appointment, suspension and dismissal of persons with executive responsibility within 
the  regulators  would  enhance  transparency  and  independence  of  the  regulatory 
authorities. 

The  appointment  of  persons  with  executive  responsibility  from  the  regulators,  as 
representatives  in  the  management  or  supervisory  entities  of  licensees  could  be 
reconsidered; if such approaches are maintained, they would benefit from a dedicated 
set of rules covering conflicts of interest. 

  Specific  conflict  of  interest  rules  and  procedures,  tailored  to  the  regulatory 
authorities,  such  as  addressing  the  rotation  of  staff  with  executive  responsibility 
between  the  nuclear  industry  and  the  regulators  (both  directions),  and  the  use  of 
external  expertise,  would  help 
the  regulators’  autonomy  and 
to  strengthen 
accountability in decision-making. 

2.3.  EXPERTISE AND SKILLS IN NUCLEAR SAFETY (Article 7) 

The  Member  States  lay  down  requirements  on  education  and  training  mainly  for  the 
regulatory authorities and the licensees (including contractors and subcontractors) through in-
house,  national  and  international  training  programmes;  this  includes  the  topic  of  on-site 
EP&R. A number of Member States highlight the challenge of the ageing and retirement of 
the  current  nuclear  workforce  and  difficulties  to  recruit  new  personnel;  solutions  to  address 
this situation are sought, including public-private partnerships and development of university 
curricula. 

Observation   

 

In the context of the ageing workforce in the nuclear area, implementing a long-term 
systematic  human  resources  planning,  driven  by  an  evaluation  of  the  current  and 
future  needs  of  the  nuclear  programme,  supported  by  activities  to  retain  and  attract 
new  talent,  as  well  as  education  and  training  partnerships,  would  contribute  to 
preserving and transferring nuclear safety-related knowledge. 

5 

 
 
 
 
2.4.  TRANSPARENCY (Article 8)  

In  most  cases,  Member  States  enacted  specific  legal  provisions,  enabling  the  regulatory 
authorities and licensees to disseminate nuclear safety-related information, complementary 
to the general legislation on the right of free access to information. 

Both  actors  use  a  wide  range  of  methods  to  disseminate  information,  both  in  normal 
operation  conditions,  and  in  case  of  incidents  or  accidents,  using  national  arrangements, 
complemented by international, regional and bilateral cooperation agreements.  

Some  regulatory  authorities  engage  in  enhanced  regulatory  cooperation,  such  as  cross-
border exercises, joint inspections, exchanges of personnel, mutual participation of experts in 
national emergency planning exercises, common training activities. 

All Member States with nuclear installations have procedures in place to  consult the public 
during the main licensing phases, particularly for siting, construction and decommissioning. 
However, these consultations are generally conducted in the context of the EU environmental 
legislation on Environmental Impact Assessments12 or international “environmental” treaties, 
such as the Espoo13 and Aarhus14 conventions. This situation may lead to a lack of certainty as 
to  whether  all  safety-significant  aspects  are  covered.  A  small  number  of  Member  States 
conduct  specific  nuclear  safety-related  public  consultations,  including  in  relation  to  major 
operational changes or long-term operation (LTO) decisions.  

Member States developed various consultation modalities, for instance, announcements in the 
press  inviting  replies  within  clear  deadlines,  non-technical  summaries,  public  hearings, 
independent  expert  panels,  dedicated  organisations  to  provide  information  to  the  public  and 
reports on how the public’s comments were taken into account. 

Observations   

  Enhanced  cooperation  between 

in  particular  of 
neighbouring  countries,  by,  inter  alia,  organising  regular  joint  exercises  covering 
information exchange and operational arrangements, would further contribute to the 
consistency and coherence of the regulatory measures, including in case of incidents 
and accidents. 

the  regulatory  authorities 

  A  self-standing  public  consultation  process  on  the  licensing  of  nuclear  installations 
from  the  perspective  of  nuclear  safety  would  strengthen  the  effectiveness  of  public 
participation on nuclear safety matters.  

III.  SAFETY OF NUCLEAR INSTALLATIONS (Articles 6, 8a – 8e of the Directive) 

3.1.  LICENCE HOLDERS (Article 6)  

While  all  Member  States  with  nuclear  installations  confirm  that  their  national  frameworks 
assign the prime responsibility for nuclear safety to the licensee, less detail is provided as 

12   Directive  2011/92/EU  of  the  European  Parliament  and  of  the  Council  of  13  December  2011  on  the 

assessment of the effects of certain public and private projects on the environment, as amended. 

13   Convention on Environmental Impact Assessment in a Transboundary Context. 

14   Convention  on  Access  to  Information,  Public  Participation  in  Decision-making  and  Access  to  Justice  in 

Environmental Matters. 

6 

 
 
                                                 
regards  the  licensees’  responsibility  for  the  activities  of  contractors  and  subcontractors, 
whose activities might affect the nuclear safety of a nuclear installation. 

The Member States with nuclear installations have various processes in place for licensees to 
regularly  assess  and  continuously  improve  safety,  for  example  through  systematic 
inspection  and  maintenance  of  safety-related  equipment,  implementation  of  ten-year  PSRs, 
systematic  evaluation  of  events,  operational  experience  feedback,  regulatory  review,  and 
compliance monitoring. The application of the defence-in-depth principles is an integral part 
of  the  safety  demonstration.  Implementation  of  the  Western  European  Nuclear  Regulators 
Association  (WENRA)  reference  levels,  outcomes  from  European  peer  reviews  (EU  Stress 
Tests  and  TPRs),  international  peer  reviews  (e.g.  World  Association  of  Nuclear  Operators 
(WANO), Safety Aspects of Long Term Operation (SALTO)) are also mentioned in some of 
the reports.  

Several  Member  States  set  out  regulatory  guides  or  instructions  addressed  to  the  licensees 
covering  associated  topics  such  as  verification  of  plant  conditions,  ageing  management  of 
components,  PSRs,  probabilistic  and  deterministic  safety  assessments,  Design  Extension 
Conditions, evaluation of internal and external hazards, as well as risks of core damage and 
release of radioactive substances. However, methodological differences exist. 

Concerning  the  licensees’  financial  and  human  resources,  the  measures  adopted  by  the 
Member States  are diverse and  include checks on  the financial  viability  of licensees,  before 
the granting of a licence and on a regular basis; definition of safety-critical functions and the 
level  of  education  and  training  required;  specific  licence  conditions  for  both  human  and 
financial  resources;  requirements  on  licensees’  management  systems;  review  of  staff  / 
organisational  changes  that  could  affect  safety;  requirements  on  contractors.  Some  Member 
States indicated that they earmark financial resources to cover all stages of the lifecycle of an 
installation. 

Observations 

  Clear  definition  of  the  licensees’  responsibility  for  the  activities  of  the  related 
contractors  and  subcontractors  would  provide  clarity  on  the  accountability  and 
responsibility for safety and improve implementation on the ground when contracting 
is involved. 

  Sharing  experience  amongst  regulatory  authorities  on  the  national  practices  of 
carrying  out  safety  assessments  and  developing  regulatory  guides  and  instructions 
based on identified good practices would be beneficial.  

  Exchanging  information  and  experience  between  regulatory  authorities  on  their 
approaches to checking the adequacy of the licensees’ financial resources would help 
increase their assessment capabilities on this topic. 

3.2.  NUCLEAR SAFETY OBJECTIVE AND ITS IMPLEMENTATION 

(Articles 8a and 8b)  

In view of the technical progress achieved at international level through the provisions of the 
International  Atomic  Energy  Agency  (IAEA)  and  WENRA,  and  responding  to  the  lessons 
learned  from  the  Fukushima  nuclear  accident  and  the  EU  Stress  Tests,  the  nuclear  safety 
objective  requires  that  nuclear  installations  are  designed,  sited,  constructed,  commissioned, 
operated  and  decommissioned  to  prevent  accidents  and,  should  accidents  occur,  to 
mitigate their consequences and avoid early and large radioactive releases. This objective 

7 

 
 
 
fully applies to all new nuclear installations and is to be used as a reference for existing ones, 
through  the  timely  implementation  of  reasonably  practicable  safety  improvements15.  An 
effective  nuclear  safety  culture  of  both  regulators  and  licensees,  together  with  the 
application  of  defence-in-depth,  are  fundamental  in  implementing  the  safety  objective,  and 
thus achieving a high level of nuclear safety and its continuous improvement. 

In  general,  the  Member  States  with  nuclear  installations  have  adopted  the  requirements 
corresponding  to  the  nuclear  safety  objective  at  a  high  level,  reflecting  the  Directive’s 
wording.  However,  the  Member  States’  implementing  approaches  differ,  with  some  cases 
where implementation is supported by more detailed regulations and regulatory guidance that 
lay  down  quantitative  interpretation  of  the  terms  or  define  regulatory  criteria  for  their 
demonstration. Some countries – particularly those pursuing the construction of new NPPs – 
point  to  their  transposition  into  national  regulations  of  the  safety  objectives  for  new  NPPs 
established by WENRA, which explicitly call for the “practical elimination” of accidents with 
core melt which would lead to early or large releases. 

The approaches vary in respect to the interpretation and quantification of accident prevention 
and the avoidance of early and large releases. While some countries focus on the avoidance of 
accident  sequences  that  lead  to  early  or  large  releases,  others  refer  to  the  avoidance  of  the 
consequential  radioactive  releases.  Still  others  use  much  earlier  versions  of  the  practical 
elimination  concept,  which  primarily  addressed  early-large  releases. 
terms  of 
quantification, some Member States define criteria in terms of the radioactive release limits, 
whilst  others  require  analysis  to  show  that  risk  criteria  and  consequential  radiological  dose 
limits  are  met.  From  a  legal  technique  perspective,  in  some  cases,  the  relevant  provisions 
transposing  the  nuclear  safety  objective  are  included  in  a  large  number  of  different 
instruments, creating a fragmentation impacting the clarity and certainty of how the objective 
is to be applied nationally. 

In 

According to Member States’ reports, the new generation of power reactors currently being 
licensed for construction in the EU are designed with a robust set of safety features to prevent 
severe accidents and to mitigate their effects and thus avoid significant radioactive releases. 

Concerning  the  over  100  existing  power  reactors,  the  Member  States  indicate  that 
reasonably  practicable  safety  improvements  have  been  identified  and  implemented,  as 
required by the Directive16. Examples of measures include the use of bunkered safety systems, 
passive  hydrogen  recombiners,  filtered  containment  venting,  and  accident  management 
procedures. The use of additional fixed and mobile equipment and procedural measures based 
on the EU Stress Test findings and resulting from recent PSRs have increased the robustness 
of installations even further. 

Some  Member  States  explain  that  it  is  not  possible  to  formulate  comprehensive  and 
unambiguous  criteria  for  determining  reasonably  practicable  safety  improvements,  and  that 
such improvements and their timeliness have to be evaluated on a case by case basis. Only a 
few  Member  States  have  chosen  to  go  further  and  develop  more  detailed  regulatory 

15   The Directive distinguishes between ‘new’ installations (understood as those granted a construction licence 
for  the  first  time  after  14  August  2014)  and  ‘existing’  installations  (understood  as  those  granted  a 
construction licence before 14 August 2014). 

16   In a few cases, Member States report that they took a more stringent approach than required by the Directive, 

by fully applying the nuclear safety objective even to existing installations. 

8 

 
 
                                                 
requirements  or  guidance,  often  incorporating  quantitative  targets  or  design  criteria. 
Therefore,  differences  in  Member  States’  approaches  to  the  implementation  of  safety 
improvements,  and  development  of  more  systematic  approaches  for  assessing  what  is 
reasonably practicable, could be the topics of further work. 

Defence-in-depth measures and the minimisation of impacts of extreme external natural and 
unintended  man-made  hazards,  are  implemented  according  to  the  standards  and  guidance 
developed by the IAEA and WENRA, with a more advanced concept applying to new reactor 
designs. 

The  Member  States  demonstrate  commitment  to  develop,  strengthen  and  monitor  safety 
culture, thus  acknowledging the importance of  organisational and human  factors in  nuclear 
safety.  Typically,  relevant  requirements  are  detailed  in  internal  procedural  documents, 
supported  by  practical  tools.  However,  as  regards  management  systems,  less  detailed  rules 
have  been  identified  concerning  regulatory  authorities  as,  in  some  cases,  the  information 
provided  refers  solely  to  the  licensees.  Clear  processes  are  in  place  for  the  internal  and 
external  safety-significant  operating  experience  and  reporting  of  safety-significant  events, 
complemented by regulatory oversight and follow-up. The safety culture is also underpinned 
by education and training arrangements.  

Progress with the post-Fukushima EU Stress Tests implementation 

Some 11 years after the Fukushima accident several Member States have not yet reported the 
completion of their post-Fukushima National Action Plans. Some of the open actions concern 
significant safety improvements, e.g. emergency control centre, additional cooling measures, 
prevention  of  containment  overpressure,  emergency  power  supply,  seismic  reinforcement, 
spent  fuel  storage  facility.  The  concerned  Member  States  reported  to  the  European  Nuclear 
Safety  Regulators  Group  (ENSREG)  at  the  end  of  2021  on  the  progress  made  to  resolve 
outstanding actions. ENSREG will issue a status report in 2022. 

Observations   

 

Increasing the mutual understanding amongst regulatory authorities of the methods to 
demonstrate  the  avoidance  of  early  and  large  releases  by  sharing  the  different 
national approaches, in particular by exchanging information on the quantitative and 
qualitative  approaches  to  demonstrate  avoidance  of  such  releases,  focusing  first  on 
the 
the  consistent 
implementation of the nuclear safety objective. 

radiological  acceptance  criteria,  would  contribute 

to 

  Exchanging  experience  amongst  regulatory  authorities  on  the  similarities  and 
differences  of  the  case  by  case  analyses  for  the  application  of  the  nuclear  safety 
objective,  focusing  on  the  decision-making  for  identifying  reasonably  practicable 
safety improvements, would strengthen consistency and transparency in the regulatory 
approaches.  These  exchanges  could  take  into  account  the  national  approaches  for 
implementing safety improvements in response to the EU Stress Tests findings. 

  Developing  and 

the  regulatory 
formalising  specific  management  systems  of 
authorities,  alongside  the  licensees’  systems,  would  contribute  to  enhancing  the 
regulators’ safety culture. 

3.3.   INITIAL ASSESSMENTS AND PERIODIC SAFETY REVIEWS (Article 8c) 

9 

 
 
As regards the initial assessment, most Member States inform on the elements that have to be 
provided  in  the  safety  analyses  reports  associated  with  a  construction  or  operation  licence 
application. 

On the PSRs, all Member States with nuclear installations report that ten-yearly reviews are 
conducted  systematically,  taking  into  account  new/revised  standards,  and  technical  and 
scientific developments. Some Member States provide examples of measures taken at NPPs, 
including  reinforcement  of  defence-in-depth.  Although  the  safety  factors  laid  down  in  the 
IAEA  standards  and  the  WENRA  reference  levels  are  frequently  cited,  few  details  are 
provided  on  the  methodology  of  the  review  process,  and,  in  particular,  on  how  the  safety 
objective is  used as a reference  to  identify safety improvements, including in  the context  of 
LTO.  Few  Member  States  report  on  measures  taken  at  other  installations,  such  as  research 
reactors. 

Observation   

  Exchange  of  information  amongst  regulatory  authorities  on  the  regulatory  practices 
concerning the scope and methodologies of the ten-year PSRs, and specifically on how 
the nuclear safety objective is taken into account systematically, would be beneficial 
for  enhancing  the  effectiveness  of  national  processes  and  increase  consistency 
between national approaches. 

3.4.  ON-SITE  EMERGENCY  PREPAREDNESS  AND  RESPONSE  (Article  6(e)  and 

8d) 

Member States  highlighted that  on-site EP&R procedures17 cover all operating modes  and 
accidents. Several measures for emergency situations were put in place in the aftermath of the 
Fukushima nuclear accident, such as additional capacities to cope with extreme natural events 
leading  in  particular  to  station  blackout  and/or  loss  of  cooling,  protocols  organising  mutual 
assistance between units on the same site or rapid reaction teams. However, not all Member 
States report explicitly on how they address situations affecting simultaneously several units, 
which was a key lesson from the Fukushima nuclear accident. 

The countries also report that the on-site emergency plans as well as their coordination and 
consistency with the national off-site EP&R arrangements are regularly tested and verified 
by  relevant  authorities  to  ensure  adequate  interfaces,  the  suitability  of  the  emergency 
equipment  and  its  redundancy,  the  competency  of  the  staff,  and  the  effectiveness  of  the 
response. 

Observation 

  Further  developing  on-site  EP&R  procedures  and  arrangements,  taking  account  of 
sites  with  multiple  units  would  respond  to  one  of  the  lessons  learned  from  the 
Fukushima nuclear accident. 

3.5.  PEER-REVIEWS (Article 8e) 

The  requirement  to  invite  every  ten  years  an  international  peer-review  on  the  national 
framework  and  regulatory  authority  started  from  the  transposition  deadline  of  the  2009 

17   The  Nuclear  Safety  Directive  covers  exclusively  on-site  arrangements,  while  the  Basic  Safety  Standards 
Directive (Directive 2013/59/Euratom) addresses both on-site and off-site arrangements. In this respect, this 
Report covers only on-site aspects and their consistency and continuity with off-site aspects at national level. 

10 

 
 
                                                 
Directive  i.e.  22  July  2011  and  was  agreed  to  be  implemented  via  the  IAEA  Integrated 
Regulatory Review Service (IRRS), for which the Commission provides financial support. In 
the ten-year period to 22 July 2021 all Member States should, as a minimum, have performed 
an  initial  IRRS  mission.  By  March  2022,  all  Member  States  have  hosted  an  initial  IRRS 
mission, though two Member States postponed their initial IRRS missions from 2020 to 2021 
and 2022 respectively, due to the Covid-19 pandemic. Furthermore, almost all Member States 
–  with  the  exception  of  three  –  have  organised  IRRS  follow-up  missions,  recommended  to 
take place no later than four years after the initial mission. While the peer review reports are 
systematically published on the IAEA website, their communication to the Commission does 
not take place consistently. The 28 IRRS missions carried out from 2015-2019 in EU Member 
States  resulted  in  recommendations,  suggestions  and  good  practices  on  themes,  such  as 
coordination  and  cooperation  among  authorities,  regulatory  body  staffing  and  competence, 
establishment of the regulatory body’s management system. Follow-up missions showed good 
progress in implementing the recommendations and suggestions showing the value of the peer 
review approach in increasing the overall level of nuclear safety. 

Concerning  TPRs,  ENSREG  identified  ageing  management  of  NPPs  and  large  research 
reactors as the subject for the first TPR held in 2017-2018. 16 EU Member States as well as 
Norway, Switzerland and Ukraine took part in the exercise; the public had also opportunities 
to participate. ENSREG drew up an Action Plan18 setting out the follow-up required, both at 
the EU level and by individual Member States. Accordingly,  Member States published their 
TPR  National  Action  Plans  by  September  2019,  and  updated  them  in  2021,  progress  made 
being  described  in  the  ENSREG  summary  report  in  November  2021.  The  next  update  of   
National Action Plans is due at the end of 2023, followed by an ENSREG summary report by 
May  2024.  TPR  findings  and  recommendations  addressed  licensees’  ageing  management 
programmes  and  more  specifically  the  ageing  effects  on  reactor  pressure  vessels,  electrical 
cables, concealed pipework and concrete containment structures. 

ENSREG has chosen fire-protection at nuclear installations as the topic for the 2nd TPR, due 
to take place in 2023-2024. The Terms of Reference and Technical Specifications should be 
adopted in the first half of 2022. 

Observations 

  Based  on  the  lessons  learned,  improving  the  methodology  of  the  TPR  exercise  by 
enhancing  the  consistency  in  identifying  technical  findings,  and  by  formulating 
challenging  recommendations  to  respond  to  the  peer  review  observations,  would 
strengthen the effectiveness of the peer-review process. 

  The participation in the TPR process of Member States without relevant installations 
is essential, considering that nuclear safety is an EU-wide concern and its impact does 
not stop at national frontiers. 

IV.  CONCLUSIONS AND WAY FORWARD 

The Commission concludes that there is, overall, a good level of implementation of the 
Directive’s  obligations  although  there  is  room  for  improvement,  as  described  in  the 
previous sections of this report and summarised below. 

Tangible progress 

18  HLG_p(2019-39)_163 ENSREG 1st TPR Action Plan 

11 

 
 
                                                 
Member  States  have  enhanced  their  nuclear  safety  legislative,  organisational  and  regulatory 
arrangements  by  strengthening  nuclear  safety  governance,  and  implementing  measures  for 
preventing  and  mitigating  accidents  at  their  nuclear  installations.  The  independence  and 
powers of the regulatory authorities were reinforced. Transparency on nuclear safety matters 
was improved, as reflected in the Member States’ information and cooperation arrangements. 

The construction of new reactors in the EU benefits from more robust design features aiming 
to prevent severe accidents and mitigate their effects,  while existing NPPs, which constitute 
the  majority  of  operating  nuclear  installations  in  the  EU,  are  subject  to  continuous  safety 
improvements  as  required  by  the  Directive.  Nuclear  installations  are  subject  nationally  to 
PSRs, with the aim to assess, verify and improve nuclear safety throughout their lifetime. 

The  first  TPR,  focusing  on  ageing  management  of  reactors  demonstrated  the  benefits  of 
cooperation to share knowledge and exchange good practices. There was also a commitment 
shown by the Member States to invite international peer-reviews of their national frameworks. 

To  respond  to  the  lessons  learned  from  the  Fukushima  nuclear  accident  and  from  the  EU 
Stress  Tests  exercise,  Member  States  have  generally  implemented  significant  safety 
improvements. However, some 10 years after the Fukushima accident, the implementation of 
some  safety  improvements  has  not  yet  been  completed  in  some  Member  States;  these 
outstanding improvements should therefore be implemented as a matter of priority. 

Challenges ahead 

Whilst the Directive resulted in  nuclear safety  enhancements in  the Member States, there is 
still  room  to  improve  its  implementation  in  a  number  of  key  areas,  in  line  with  the 
observations presented in sections II and III of the report. 

In  particular,  the  high-level  nature  of  the  provisions  of  the  Directive  leaves  room  for 
interpretation,  leading  to  differing  regulatory  approaches  in  identifying  the  necessary  safety 
improvements. Nuclear safety in  the EU would  benefit from a more coherent  application of 
the  nuclear  safety  objective  based  on  a  more  systematic  approach  for  assessing  what  is 
reasonably  practicable.  Consistency  between  national  approaches  and  effectiveness  of 
national  processes  could  be  enhanced  through  a  more  coherent  implementation  of  safety 
assessments and in particular the PSRs, including in the context of LTO. 

There  is  also  scope  for  further  enhancing  the  effective  independence  of  the  competent 
regulatory authority from undue influence in its regulatory decision-making by improving the 
effectiveness  of  national  arrangements  currently  in  place  in  a  number  of  areas,  such  as 
functional  separation,  financial  and  human  resources,  and  conflicts  of  interest.  Public 
participation in the decision-making process related to the relevant lifecycle stages of nuclear 
installations  could  be  strengthened,  as  well  as  the  formal  introduction  of  safety  culture 
provisions  in  the  documentation  of  management  systems  at  some  regulatory  authorities. 
Further efforts should also be made to ensure sustainability and development of expertise and 
skills in nuclear safety. 

Recommendations for future action at EU level 

To  enhance  the  effectiveness  and  consistency  of  the  national  approaches,  some  of  the 
observations  presented  in  sections  II  and  III  of  the  report  can  be  supported  by  a  more 
coordinated and collaborative action at EU level based on a structured exchange of views and 
experiences.  

12 

 
 
The  following  recommendations  are  therefore  made  to  the  Member  States  to  work  together 
towards developing common approaches at EU level: 

  Enhance the independence of the regulatory authorities from undue influence in 
their  regulatory  decision-making  by  elaborating  a  set  of  common  guiding 
principles underlying essential features, such as: 

o  effective separation from any other body or  organisation concerned with 

the promotion or utilisation of nuclear energy;  

o  dedicated and appropriate budget allocations;  

o  appropriate number of staff with qualifications, experience and expertise, 

and preservation of knowledge;  

o  prevention and resolution of conflicts of interest. 

  Strengthen  the  capabilities  of 

their  prime 
responsibility  for  nuclear  safety  by  elaborating  a  set  of  common  guiding 
principles underlying essential features, such as: 

licence  holders  to  exercise 

o  preservation of knowledge and attracting qualified staff;  

o  adequacy of the financial resources; 

o  management of the activities of contractors and subcontractors. 

  Promote  and  enhance  an  effective  nuclear  safety  culture  by  exchanging 
information on national policies and arrangements and developing best practices, 
in particular on the regulators’ own safety culture and management systems. 

  Strengthen  transparency  by  drawing  up  guidelines  on  effective  public 
participation  in  the  decision-making  process  related  to  the  relevant  lifecycle 
stages of nuclear installations, from a nuclear safety viewpoint. 

  Support the implementation of the nuclear safety objective by: 

o  developing a common understanding of the underlying technical basis and 
its  application  in  practice,  including,  in  particular,  implementation 
approaches  for  the  avoidance  of  ‘early’  and  ‘large’  radioactive  releases, 
and  determination  of  reasonably  practicable  safety  improvements  for 
existing installations, which are increasingly being identified for LTOs. 

o  enhancing  coherence  in  implementing  safety  assessments,  in  particular 
PSRs,  by  developing  guidance  on  the  scope  and  methodologies  of  the 
process;  it  should  also  address  the  systematic  use  of  the  nuclear  safety 
objective as a reference. 

  Improve  the  effectiveness  of  the  TPR  exercise  by  strengthening  consistency  in 
identifying technical findings and drawing more challenging recommendations to 
respond to the peer review observations. 

The Commission will seek the views of Member States and their regulatory authorities, in the 
frame  of  ENSREG,  of  licensees,  as  well  of  other  stakeholders,  including  civil  society  to 
define  the  concrete  processes  and  timetables  for  initiating  the  above  EU-level  actions.  As  a 
result of this initial consultation process, the Commission will facilitate the implementation of 
these recommendations, including through organising workshops, conferences, meetings and 
studies. The Commission will take into account the views of the European Parliament and the 
Council in this process. 

13 

 
 
In view of the areas where further actions have been identified at the national level and at the 
EU  level,  Member  States  are  encouraged  to  further  report  on  progress  with  the  Directive’s 
implementation. This would further improve citizens’ understanding of current nuclear safety 
issues,  help  in  public  engagement  and  participation,  and  enhance  public  confidence  in  the 
responsibilities and activities of licensees and national safety authorities. 
In line with the EU Better Regulation19 principles, the Commission intends to conduct in due 
course  a  standard  evaluation  of  the  Directive  to  assess  to  what  extent  it  was  successful  in 
achieving its goals or whether there is scope for a future reform of the legislative framework 
to  improve  its  effectiveness,  relevance  or  coherent  application,  also  taking  into  account  the 
progress with the actions proposed in this report. 

19   See  in  detail  the  Commission's  "Better  Regulation  Guidelines":  https://ec.europa.eu/info/law/law-making-

process/planning-and-proposing-law/better-regulation-why-and-how/better-regulation-guidelines-and-
toolbox_en    

14