—

Having regard to the Aarhus Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters, which was signed by the European Community and all the EU Member States in 1998,

—

Having regard to the implementation of the Aarhus Convention in the context of nuclear safety, as brought about by the ‘Aarhus Convention and Nuclear’ initiative, which requires Member States to publish key information concerning nuclear safety and to involve the public in the decision-making process,

(6)

Council Directive 2011/70/Euratom of 19 July 2011 establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste (33) imposes obligations on the Member States to establish and maintain a national framework for spent fuel and radioactive waste management.

(6)

Council Directive 2011/70/Euratom of 19 July 2011 establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste (33) imposes obligations on the Member States to establish and maintain a national framework for spent fuel and radioactive waste management. The European Parliament resolution of 14 March 2013 on risk and safety assessments (‘stress tests’) of nuclear power plants in the European Union and related activities  (33a) recalled that the hazards of nuclear waste were once again highlighted by the Fukushima nuclear accident.

(7)

Council Conclusions of 8 May 2007 on nuclear safety and safe management of spent nuclear fuel and radioactive waste (34) 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’.

(7)

Council Conclusions of 8 May 2007 on nuclear safety and safe management of spent nuclear fuel and radioactive waste (34) 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’. However, in its resolution of 14 March 2013 on risk and safety assessments (‘stress tests’) of nuclear power plants in the European Union and related activities, the European Parliament took note of the cross-border relevance of nuclear safety, for example by recommending that periodic safety reviews should be based on common safety standards or that cross-border safety and supervision should be ensured. That resolution called for the definition and implementation of binding nuclear safety standards.

(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 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.

(15)

A strong and independent competent regulatory authority is a fundamental condition of the European nuclear safety regulatory framework. Its legal 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 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 and the Commission or to general policy guidelines issued by the government that do not undermine the national authority's regulatory powers and duties.

(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.

(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 and by exchanges of knowhow between countries within and outside the Union 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.

(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 incidents and accidents. Results of periodic safety reviews and international peer reviews should also be made public. In its resolution of 14 March 2013 on risk and safety assessments (‘stress tests’) of nuclear power plants in the European Union and related activities, the European Parliament called for the Union’s citizens to be fully informed and consulted on nuclear safety in the Union.

(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 emergency (42) 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 1989 (43) 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.

(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 emergency (42) 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 1989 (43) 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 incidents or accident conditions.

(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 learned from the stress tests and the Fukushima nuclear accident 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).

(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 learned from the stress tests and the Fukushima nuclear accident investigations, Directive 2009/71/Euratom should be amended to include legally binding Community nuclear safety objectives covering all stages of the lifecycle of nuclear installations (siting, design, construction, commissioning, operation, decommissioning).

(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.

(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 should 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.

(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 or corrected by appropriate measures. The independent effectiveness of each of the different layers is an essential element of defence in depth to prevent accidents , detect and control deviations and mitigate the consequences if they do occur.

(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.

(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 within the framework of ENSREG , 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.

(33a)

Considering the risks of duplication with existing international peer review processes and the risk of interference in the work of independent national regulatory authorities, topical peer reviews should build on the experience gained by ENSREG and WENRA during the European safety reassessments after Fukushima. ENSREG should be entrusted by Member States with the choice of topics, the organisation of the topical peer review, its implementation, and follow-up actions.

(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.

(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 in the context of different applications as well as help formulate generic technical safety recommendations and guidelines valid across the Union.

(36)

In case the Commission identifies 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 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.

(36)

In case the Commission , in close coordination with ENSREG, identifies substantial deviations or delays in the implementation of the technical recommendations from the peer review process, the Commission should invites 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.

(42a)

ENSREG, which has the experience of the European stress tests exercise and is composed of all Union nuclear safety regulators and the Commission, should be closely involved in the selection of the topics subject to regular peer reviews, in the organisation of those topical peer reviews and in ensuring their follow-up, in particular regarding implementation of the recommendations.

(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.

(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 limit unauthorised radioactive releases to a minimum .

(2a)

7.

7a.

8.

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

8.

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

8a.

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;

12.

‘reasonably practicable ’ 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 the national regulatory authority accepts that they are demonstrated to be 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;

13.

‘design basis’ means the range and cumulative effect 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;

14.

‘design basis accident’ means an accident causing accident conditions for which a facility is designed in accordance with established design criteria and conservative methodology, and for which releases of radioactive material are kept within acceptable limits;

15.

16a.

17a.

17b.

(a)

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

(a)

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

(c)

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

(c)

establishes a transparent regulatory decision-making process , founded on objective and verifiable safety-related criteria;

(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;

(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 and should include provisions for the adequate generation of new and management of existing knowledge, expertise and skills ;

(e)

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

(e)

employs an appropriate number of staff , all of whom, in particular politically appointed board members, possess the necessary qualifications, experience and expertise to fulfil its obligations and that have access to external scientific and technical resources and supporting expertise as far as considered necessary in support of its regulatory functions and in accordance with the principles of transparency, independence and integrity of regulatory processes ;

(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).

(e)

to carry out enforcement actions, including penalties in accordance with Article 9a and suspending the operation of a nuclear installation in accordance with the conditions defined by the national framework referred to in Article 4(1);

(f)

to provide appropriate conditions for the research and development activities needed to develop the necessary knowledge base and to support the management of expertise for the regulatory process.

(a)

practically eliminating the occurrence of all accident sequences which would lead to early or large releases;

(a)

practically eliminating the occurrence of all accident sequences which would lead to early or large releases to a level as low as reasonably practicable ;

(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.

(b)

in the event of an accident , 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.

(a)

sited so that due consideration is provided to avoid , where possible, external natural and man-made hazards and minimise their impact;

(a)

sited so that due consideration is provided to prevent external natural and man-made hazards and minimise their impact;

(b)

designed, constructed, commissioned, operated and decommissioned based on the defence-in-depth concept so that:

(b)

designed, constructed, commissioned, operated and decommissioned based on the defence-in-depth concept so that:

(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;

(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;

(b)

defines, documents and re-assesses regularly and at least every eight 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)

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;

(c)

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;

(d)

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

(d)

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

(e)

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;

(e)

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;

(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.

(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. Any measures mandated by the regulatory authority to prevent beyond-design basis accidents shall be implemented before an extension of lifetime is authorised.

(a)

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

(a)

prepares and regularly updates , at least every eight years, an on-site emergency plan which shall:

(b)

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

(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;

(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;

(d)

provides for preparedness measures for the workers on-site with regard to potential incidents and accidents;

(e)

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

(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;

(f)

arranges for an on-site emergency response centre, sufficiently protected against natural hazards and radioactivity to ensure its habitability in the event of and throughout potential crisis management situations ;

(g)

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

(g)

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

(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;

(a)

jointly 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;

(b)

assess to what extent these topics have been addressed and, where needed , perform in close collaboration with licence holders, national assessments of the installations, to be evaluated by the competent regulatory authority 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;

(c)

jointly define a methodology, arrange and carry out a peer review of the results of the national assessments referred to in point (b),

(d)

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

(d)

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