Considerations on COM(2013)343 - Amending Directive 2009/71/EURATOM establishing a Community framework for the nuclear safety of nuclear installations

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(1) 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.

(2) 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.

(3) 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 radiation[26] 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.

(4) The Court of Justice of the European Union has recognised in its case-law[27] that the Community shares competences, together with its Member States, in fields covered by the Convention on Nuclear Safety[28].

(5) Council Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations[29] 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 Safety[30] and the Safety Fundamentals[31] 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.

(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[32] imposes obligations on the Member States to establish and maintain a national framework for spent fuel and radioactive waste management.

(7) Council Conclusions of 8 May 2007 on nuclear safety and safe management of spent nuclear fuel and radioactive waste[33] 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”.

(8) 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 Management[34] to contribute to the achievement of the Community objectives in the field of nuclear safety.

(9) 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 2011[35], 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 tests'). The results identified a number of improvements which could be implemented in nuclear safety approaches and industry practices in the participating countries[36].

(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 Union[37] 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 activities[38].

(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 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 environment[39] 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 Protection Mechanism[40] 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 emergency[41] 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[42] 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.

(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).

(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 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.

(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) 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.

(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 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.