Proposal for a directive
Annex (new)
Annex SAFETY OBJECTIVE The fundamental safety objective is to protect workers and the general public from harmful effects of ionising radiation, which may be caused by nuclear installations. 1. To ensure the protection of workers and the general public, nuclear installations shall be operated so as to achieve the highest standards of safety that can reasonably be achieved taking into account economical and social factors. In addition to the measures concerning health protection, laid down in the Euratom Basic Standards (Directive 96/29/Euratom), the following measures shall be taken: - restriction of the likelihood of events that might lead to a loss of control over a nuclear reactor core, nuclear chain reaction, radioactive source and - mitigation of the consequences of such events if they were to occur. 2. The fundamental safety objective shall be taken into account for all nuclear installations and for all stages over the lifetime of the nuclear installation. SAFETY PRINCIPLES Principle 1: Responsibility for safety Each Member State shall ensure that the prime responsibility for the safety of a nuclear installation rests with the holder of the relevant licence and shall take the appropriate steps to ensure that all such licence holders meet their responsibility. 1.1 Each Member State shall ensure that the licensee has implemented provisions for: - establishing and maintaining the necessary competences; - providing adequate training and information; - establishing procedures and arrangements to maintain safety under all conditions; - verifying appropriate design and the adequate quality of nuclear installations; - ensuring the safe control of all radioactive material that is used, produced or stored; - ensuring the safe control of all radioactive waste that is generated to fulfil the responsibility for the safety of a nuclear installation. These responsibilities shall be fulfilled in accordance with applicable safety objectives and requirements as established or approved by the regulatory body, and their fulfilment shall be ensured through the implementation of a management system. Principle 2: Leadership and management for safety Effective leadership and management for safety must be established and sustained in all organisations concerned with nuclear safety. 2.1 Leadership in safety matters shall be demonstrated at the highest levels in an organisation. An effective management system shall be implemented and maintained, integrating all elements of management so that requirements for safety are established and applied coherently with other requirements, including those relating to human performance, quality and security, and so that safety is not compromised by other requirements or demands. The management system also shall ensure the promotion of a safety culture, the regular assessment of safety performance and the application of lessons learned from experience. 2.2 A safety culture that governs the attitudes and behaviour in relation to safety of all organizations and individuals concerned shall be integrated in the management system. Safety culture includes: - individual and collective commitment to safety on the part of the leadership, the management and personnel at all levels; - accountability of organisations and of individuals at all levels for safety; - measures to encourage a questioning and learning attitude and to discourage complacency with regard to safety. 2.3 The management system shall recognise the entire range of interactions of individuals at all levels with technology and with organisations. To prevent safety, significant human, and organisational failures, human factors shall be taken into account and good performance and good practices shall be supported. Principle 3: Assessment of Safety Comprehensive and systematic safety assessments shall be carried out before the construction and commissioning of a nuclear installation and throughout its lifetime. A graded approach shall be used taking in account the magnitude of the potential risks arising from the nuclear installation. 3.1 The regulatory body shall require an assessment on nuclear safety for all nuclear installations, consistent with a graded approach. This safety assessment shall involve the systematic analysis of normal operation and its effects, of the ways in which failures might occur and of the consequences of such failures. The safety assessments shall cover the safety measures necessary to control the hazard, and the design and engineered safety features shall be assessed to demonstrate that they fulfil the safety functions required of them. Where control measures or operator actions are called on to maintain safety, an initial safety assessment shall be carried out to demonstrate that the arrangements made are robust and that they can be relied on. An authorisation for a nuclear installation shall only be granted by a Member State once it has been demonstrated to the satisfaction of the regulatory body that the safety measures proposed by the licensee are adequate. 3.2 The required safety assessment shall be repeated in whole or in part as necessary later in the conduct of operations in order to take into account changed circumstances (such as the application of new standards or scientific and technological developments), the feedback of operating experience, modifications and the effects of ageing. For operations that continue over long periods of time, assessments shall be reviewed and repeated as necessary. Continuation of such operations shall be subject to these reassessments demonstrating that the safety measures remain adequate. 3.3 Within the required safety assessment precursors to accidents (an initiating event that could lead to accident conditions) shall be identified and analysed, and measures shall be taken to prevent the occurrence of accidents. 3.4 To further enhance safety, processes shall be put in place for the feedback and analysis of operating experience in own and other facilities, including initiating events, accident precursors, "near misses", accidents and unauthorised acts, so that lessons may be learned, shared and acted upon. Principle 4: Optimisation of safety Member States shall ensure that nuclear installations are optimised to provide the highest level of safety that can reasonably practicable be achieved without unduly limiting their operation. 4.1 The optimisation of safety shall require judgements to be made about the relative significance of various factors, including: - the likelihood of the occurrence of foreseeable events and the resulting consequences; - the magnitude and distribution of radiation doses received; - economic, social and environmental factors arising from the radiation risks. - The optimisation of safety also means using good practices and common sense as far as is practical in day to day activities. Principle 5: Prevention and mitigation Member States shall ensure that all practical efforts are made to prevent and mitigate nuclear incidents and accidents in its nuclear installations. 5.1 Each Member State shall ensure, that the licensees engage all practical efforts - to prevent the occurrence of abnormal conditions or incidents that could lead to a loss of control; - to prevent the escalation of any such abnormal conditions or incidents that do occur; and - to mitigate any harmful consequences of an accident. by implementing “defence in depth”. 5.2 The application of the defence in depth concept shall ensure that no single technical, human or organisational failure could lead to harmful effects, and that the combinations of failures that could give rise to significant harmful effects are of very low probability. 5.3 Defence in depth shall be implemented through the combination of a number of consecutive and independent levels of protection that would all have to fail before harmful effects could be caused to workers or the general public. The levels of defence in depth shall include: - an adequate site selection - an adequate design of the nuclear installation, consisting of High quality of design and construction High reliability of components and equipment Control, limiting and protection systems and surveillance features; - an adequate organisation with An effective management system with a strong management commitment to safety culture Comprehensive operational procedures and practices Comprehensive accident management procedures Emergency preparedness arrangements Principle 6: Emergency preparedness and response Members States shall ensure that arrangements are made for emergency preparedness and response for nuclear installations accidents according to Directive 96/29/Euratom.