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Royal Decree 35/2008 Of 18 January, Amending The Regulation On Nuclear And Radioactive Facilities, Approved By Royal Decree 1836 / 1999 Of 3 December.

Original Language Title: Real Decreto 35/2008, de 18 de enero, por el que se modifica el Reglamento sobre Instalaciones Nucleares y Radiactivas, aprobado por Real Decreto 1836/1999, de 3 de diciembre.

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TEXT

The Regulation on existing nuclear and radioactive installations was approved by Royal Decree 1836/1999 of 3 December. Since its entry into force, the application of the same and the experience gained have revealed the existence of a number of improvements and shortcomings which advise its review. Likewise, the laws which constitute its reference framework, that is, Law 25/1964 of 29 April on nuclear energy, and Law 15/1980 of 22 April of the creation of the Nuclear Safety Council, have been amended by Law 24/2005, November 18, reforms to boost productivity, and Law 33/2007, of November 7, of reform of Law 15/1980, of April 22. The liberalisation of the electricity market has shown the need to take into account its possible impact on the safety of nuclear installations related to electrical generation, and has therefore been included among the the responsibility of the holder to ensure that the new techniques are incorporated in order to carry out the management under the most up-to-date safety standards. Coordination mechanisms are also established with the competent authorities to authorise installations and activities which, due to their characteristics and situation, could have an impact on a first nuclear or radioactive installation. category. The requirement for the establishment, on the part of the holder, of a procedure for the staff of the installation, as well as that of the contracted companies and those of the external persons providing their services in the same, to comply with the duty of to make known to the holders any known facts affecting or likely to affect the safe operation of the holders and compliance with the existing rules on nuclear safety or radiation protection. As far as the system of authorizations is concerned, the provisions of Article 28 of Law 25/1964 of 29 April on nuclear energy, according to which the autonomous communities with competence in the field of nuclear power are to be heard, have been developed. management of the territory and the environment. In view of the increasing importance of the physical protection aspects of nuclear installations and materials, the requirement for the inclusion of a physical protection plan between the documentation is incorporated. required for the approval of the facilities. The procedure for granting authorisations for radioactive installations has been speeded up, and the system for granting authorizations for the decommissioning and decommissioning of nuclear installations is regulated in greater detail. In relation to the inspector's function, the possibilities for action in other areas with equipment or materials that require it and cover for action in exceptional situations on installations not subject to the scheme are extended. granting of authorisations to the Regulation on nuclear and radioactive installations. As far as the system of operator and supervisor licences is concerned, its rules are extended, in particular in the case of licences relating to nuclear installations and the nuclear fuel cycle, both in operation and in the case of The Commission has also been able to take the necessary steps to implement the measures. As a novel aspect, control of contaminated areas is regulated, which is intended to provide a solution to the control of land or hydrological resources, which does not belong to installations covered by the Regulation on nuclear installations and Radioactive contamination has been affected by radioactive contamination. Finally, as another aspect of this amendment, reference is made to the regulation of certification and validation of new designs or models by the Nuclear Safety Board. The preparation of this royal decree was initiated on the proposal of the Nuclear Safety Council, in accordance with the provisions of Article 2 (a) of its Law of Creation, Law 15/1980, of 22 April, having given a hearing to the sectoral economic agents and social stakeholders, as well as consulting the autonomous communities. The royal decree which is adopted has its legal basis in Law 25/1964 of 29 April on nuclear energy, particularly in its Articles 28, 36, 37 and 94, as well as in Article 13 of Law 15/1980 of 22 April of the creation of the Council of Nuclear Security, in the wording given in point 9 of the single article of Law 33/2007, of 7 November, that the reform. Finally, the content of the provision has been communicated to the Commission of the European Union in accordance with Article 33 of the Treaty establishing the European Atomic Energy Community (EURATOM). In its virtue, on the proposal of the Minister of Industry, Tourism and Trade, with the prior approval of the Minister of Public Administrations, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting of the 18 day of January 2008,

D I S P O N G O:

Article first. Amendment of Title I of the Regulation on nuclear and radioactive installations, approved by Royal Decree 1836/1999 of 3 December.

Title I of the Regulation on nuclear and radioactive installations, approved by Royal Decree 1836/1999 of 3 December, is amended as follows: Article 2 is worded as follows:

" Article 2. Competent authorities.

1. The application of the provisions of this Regulation corresponds to the Ministry of Industry, Tourism and Trade and the Nuclear Safety Council, without prejudice to the powers of other departments and the Autonomous Communities.

2. The executive functions of the Ministry of Industry, Tourism and Trade, in relation to the second and third category of radioactive installations, shall be construed as being attributed to the Autonomous Communities when they are have transferred these functions. 3. Operating authorisations for second and third category radioactive installations shall be valid for the entire Spanish territory. Without prejudice to the foregoing, the holder who is to carry out any of the activities for which he is authorized, in a particular part of the territory, must notify the competent territorial administration of the activity, which may be start its activity on the basis of the notification, which must be accompanied by a certified copy of the authorization. It shall be understood that there is no objection to the foregoing if the competent authority in that territory has not expressed such opposition by means of a reasoned decision within three months from the date of notification. '

Two. A new Article 3a is added, with the following wording:

" Article 3a. Duty to report.

1. The competent authorities for the granting of a significant authorisation or modification of an installation or activity, which because of its characteristics or situation could have an impact on a nuclear or radioactive installation of the first category, prior to the issuance of such authorisation or modification, shall transfer to the Nuclear Safety Board the security report or sufficient information on the matter, in order to be issued by this public body mandatory, which will be binding in the terms laid down in Law 15/1980 of 22 April, creation of the Nuclear Security Council.

If of the evaluation of this information by the Nuclear Safety Council, this body concludes that an increase in the risk of nuclear or radioactive installation cannot be ruled out, as a result of the new installation or activity, or the modification of the existing installation or activity, may result in measures to be implemented either in the nuclear or radioactive installation or in the non-nuclear installation or activity. 2. Where the communication provided for in the preceding paragraph does not take place, the Nuclear Safety Board may apply to the bodies of the competent authority on its own initiative and to obtain the information necessary for the preparation of such information. report. The bodies concerned, in collaboration with the Nuclear Safety Board, shall establish communication protocols ensuring that the establishments so determined and the first class nuclear and radioactive installations are considered. exchange the necessary data in an appropriate manner, in order to enable the holders to take into account the nature and magnitude of the general risk of serious accidents in their policies for the prevention of serious accidents, security, safety reports and internal emergency plans. "

Three. Article 4 is worded as follows:

" Article 4. Submission of applications.

1. Applications to obtain the authorizations granted by the Ministry of Industry, Tourism and Trade must be addressed to the Ministry, meeting the requirements set out in Article 70 of the Law on the Legal Regime of Public Administrations. of the Common Administrative Procedure, and shall be accompanied by the documentation set out in each case.

If the Ministry of Industry Tourism and Trade appreciates that the documentation submitted is incomplete or insufficient content, it will require the person concerned to complete, clarify or extend it within ten days. 2. The Ministry shall transmit a copy of all the documentation to the Nuclear Safety Board for its mandatory report. Furthermore, in accordance with Article 28 of Law 25/1964 of 29 April 1964 on nuclear energy, it shall, where appropriate, transmit a copy of all the documentation to the Autonomous Communities with powers in the field of management of the the territory and the environment in the territory of which the installation or planning area provided for in the basic rules on nuclear and radiological emergency planning is located, for the purpose of making claims within the time limit of a month, in accordance with Article 12.3 of this Regulation. "

Four. Article 7 is worded as follows:

" Article 7. Granting of authorisations.

The Ministry of Industry, Tourism and Trade, once received the report of the Nuclear Safety Council, and prior to the relevant opinions and reports, will adopt the appropriate resolution. The maximum period for the notification of such a decision shall be six months, unless the suspension referred to in paragraph 2 of the preceding Article applies, in which case the maximum period shall be extended by the period of suspension.

The authorizations to be granted shall consist of:

a) Holder of the authorization.

b) Localization of the installation. (c) Activities which enable the authorisation to be granted. (d) the term of validity and the conditions for its renewal, where appropriate. (e) The purpose of the installation and, where appropriate, the basic characteristics of the installation. (f) Where applicable, nuclear substances and other materials and equipment producing ionising radiation the possession or use of which is authorised. (g) Official documents under which the relevant authorisation and procedure for its review is granted. (h) Requirements regarding the licensing of personnel for the operation of the facility. (i) guarantees that the holder has to agree on civil liability for nuclear damage to third parties. (j) Limits and conditions in respect of nuclear safety and radiation protection. (k) Other conditions which may be relevant to the case. "

Five. Article 8 is worded as follows:

" Article 8. Responsibility of the holder.

1. The holder of each authorisation shall be responsible for the operation of the installation or activity under security conditions, and always within the framework of the official documents under which the relevant authority is granted. authorisation. It is up to him to apply and keep this documentation updated, to inform the Ministry of Industry, Tourism and Trade and the Nuclear Security Council of how many matters may affect the conditions of authorization or security. Nuclear safety and radiation protection and, in general, compliance with existing regulations. The operator must also be responsible for the installation in the emergency situations which may occur.

The holder shall ensure that all natural or legal persons acting as contractors or subcontractors also comply with the requirements of the preceding paragraph, in those cases that correspond to them. 2. In the field of safeguards and the physical protection of nuclear materials, the holder shall be obliged to carry out the activities of monitoring, control and custody of such materials, to allow inspections and checks to be carried out. precise, where these are derived from the commitments entered into by the Spanish State or the internal order itself, and to inform the authorities of any relevant facts, in accordance with the specific rules in this field. 3. The operator shall ensure continuous improvement of the nuclear safety and radiation protection conditions of its installation. To this end, it shall analyse the best existing techniques and practices, in accordance with the requirements established by the Nuclear Safety Board, and implement those that are suitable for the opinion of the Nuclear Safety Board. The Nuclear Safety Board may at any time require the analysis of the holder for the implementation of improvements in nuclear safety and radiation protection. "

Six. A new Article 8a is added, with the following wording:

" Article 8a. Communication of deficiencies.

According to the provisions of article 13 of Law 15/1980 of 22 April of the creation of the Nuclear Safety Council, for the purpose of the duty of persons to the service of nuclear and radioactive installations to put in knowledge of the holders of any event which may affect the safe operation of the operators or the radiation protection: (a) The operator shall establish a procedure to ensure that all staff in the organisation of the installation, as well as those of the contracted companies and the external staff providing their services, communicate to the holder those deficiencies or dysfunctions which, in the opinion of the communicant, could affect nuclear safety or radiation protection, without prejudice to the general rights of the citizen as set out in the relevant laws.

This procedure will be additional to the usual channels of communication and can be used at the choice of the communicant. The communicant must also have recourse to this procedure if, after failing to report any deficiencies in the usual channels of communication, it came to the conclusion that its complaint or complaint had not been sufficiently addressed. All communications must be addressed in the procedure, whether they come from communicants identified as anonymous, and such communications must be included in a numbered and dated record with copies of the communications received, and reference to the information provided in response to the information and to the measures taken to verify or the measures taken in its application. Radioactive installations for scientific, medical, agricultural, commercial or industrial purposes, as defined in Title III of this Regulation, may choose to register such communications and the replies and/or measures of verification or measures taken in the operation journal referred to in Title VI of this Regulation. The communicant, if identified, shall receive a written reply in less than 7 working days from the operator of the facility with the information on the measures taken or those envisaged. After that period without the holder referring the written reply to the communicant, the latter shall transmit to the Nuclear Security Council the information in question. The procedure will guarantee the existence of an abbreviated procedure for those cases in which the communicator appreciates urgent reasons, for which the obligation of the holder to respond to the communicant will be established immediately, If you consider it appropriate, the information to the Nuclear Security Council at the time it warns of the deficiency or dysfunction is transmitted. Without prejudice to the foregoing, in this matter, the Law 30/1992, of 26 November, of the Legal Regime of Public Administrations and of the Common Administrative Procedure, will be applicable. (b) The exercise of this right may not have adverse effects on the worker in his or her job, except in cases where bad faith in his/her performance is credited. The decisions of the holder taken to the detriment or prejudice to the employment rights of workers who have exercised the right provided for in this Article shall be construed as null and void. '

Article 2. Amendment of Title II of the Regulation on nuclear and radioactive installations, approved by Royal Decree 1836/1999 of 3 December.

Title II of the Regulation on nuclear and radioactive installations, approved by Royal Decree 1836/1999 of 3 December, is amended as follows: Article 11 is worded as follows:

" Article 11. Definitions.

They are nuclear facilities: (a) Nuclear power plants: any fixed installation for the production of energy by a nuclear reactor.

(b) Nuclear reactors: any structure containing nuclear fuels arranged in such a way that a nuclear fission process can take place without the need for an additional source of nuclear fission. neutrons. (c) factories using nuclear fuels for the production of nuclear substances and the factories in which nuclear substances are treated, including facilities for the treatment or reprocessing of irradiated nuclear fuels. (d) storage facilities for nuclear substances, except where such substances are stored incidentally during their transport. (e) devices and installations using fusion or fission nuclear reactions to produce energy or for the production or development of new energy sources. "

Two. Article 12 is worded as follows:

" Article 12. Required authorisations.

1. Nuclear installations shall, as appropriate, require the following authorisations:

(a) Prior or formal authorisation: it is an official recognition of the proposed objective and the suitability of the chosen site, the acquisition of which entitles the holder to apply for the authorisation of the construction of the installation and start the preliminary infrastructure works that are authorized. (b) Construction authorisation: entitles the holder to start the construction of the installation and to apply for the holding authorisation. (c) "operating authorisation": entitles the holder to charge the nuclear fuel or to introduce nuclear substances into the facility, to carry out the nuclear test programme and to operate the facility under the conditions laid down in the authorisation. It shall be granted on a provisional basis until the satisfactory completion of the nuclear tests. This authorisation also empowers the holder, after the operation for which the installation was conceived, to carry out the operations required by the Administration prior to obtaining the authorization to decommission. (d) Authorisation of modification: entitles the holder to make modifications to the design of the installation or to its operating conditions, in cases where the criteria, rules and conditions on which the authorisation is based are based exploitation. (e) Authorisation for the execution and assembly of the modification: entitles the holder to initiate the execution, execution and assembly of those modifications which, by their great scope or because they involve significant works and assemblies, are deemed necessary expressly authorise, in the opinion of the Directorate-General for Energy Policy and Mines or the Nuclear Safety Council. (f) Decommissioning authorisation: after the authorisation of the holding has been extinguished, the holder shall have the right to initiate the activities of decontamination, dismantling of equipment, demolition of structures and removal of materials, in order to permit term, the total or restricted release of the site. The decommissioning process shall end in a closing declaration, which shall release the holder of an installation of his or her responsibility as an operator of the decommissioning and shall define, in the case of restricted release of the site, the limitations (i) use that they are applicable and responsible for maintaining and monitoring compliance. Additionally, you must be authorized:

g) The temporary storage of nuclear substances in a construction phase facility that does not have an operating authorisation.

h) The change of ownership of the nuclear facilities. The new holder shall establish sufficient legal, technical and economic-financial capacity to carry out the activities covered by the authorisation. The authorisations provided for in the preceding paragraphs shall be granted on the basis of a report from the Nuclear Safety Board as provided for in this Regulation.

2. The nuclear installations referred to in Article 11 (b) and (d) of this Regulation, except for the disposal of radioactive waste disposal facilities, may at the same time apply for prior authorisation and for construction.

3. Prior to the granting of the authorisations referred to in paragraph 1 of this Article, with the exception of those referred to in points (e) and (g) of that paragraph, the documentation relating to the Autonomous Community shall be transferred by the a month, for claims, in accordance with the provisions of Article 4.2 of this Regulation. 4. It is for the Minister for Industry, Tourism and Trade to grant the authorisations referred to in paragraph 1 of this Article, except those referred to in points (d), (e) and (g), which correspond to the Director-General for Energy Policy and Mines. '

Three. Article 13 is worded as follows:

" Article 13. Committee for information.

1. During the construction, operation and dismantling of nuclear power stations, an Information Committee shall operate, which shall have the status of the collegiate bodies provided for in Article 40.3 of Law 6/1997 of 14 April of the Organization and Operation of the General Administration of the State.

2. This Committee, whose members shall be appointed by the Director-General for Energy Policy and Mines, shall be composed of a representative of the Ministry of Industry, Tourism and Trade, the holder of the installation, the Nuclear Safety Board, the delegations of the Government and the Autonomous Communities in whose territory the installation is located, the Directorate General for Civil Protection and Emergencies and the Municipalities included in Zone 1 defined in the corresponding Plans of External emergency to nuclear power stations. He will be chaired by the representative of the Ministry of Industry, Tourism and Commerce, and will be the vice president of the municipality in whose territory the facility is located. An official from the Ministry of Industry, Tourism and Trade, appointed by the Director-General for Energy Policy and Mines, will act as secretary of the Committee. Other representatives appointed by the Director-General for Energy Policy and Mines may also be included, either on their own initiative or on a proposal from the Committee. 3. It shall be the task of this Committee to inform the various entities represented on the development of the activities covered by the relevant authorisations and to deal jointly with those other issues which are of interest to them. entities. '

Four. Article 20 is worded as follows:

" Article 20. Request.

The application for the operating authorisation shall be accompanied by the following documents, which shall, where appropriate, update the content of the documents submitted when applying for the construction authorisation: (a) Safety study. It shall contain the information necessary to carry out an analysis of the installation from the point of view of nuclear safety and radiation protection, as well as an analysis and risk assessment resulting from the operation of the facility, both under normal conditions as in accident conditions. It shall also contain detailed descriptions of the security functions, all security systems and the safety-related structures, systems and components, of their design bases and their operation in all states. operations, including stop and accident conditions. It shall also identify the regulations, codes and rules applicable to the installation. In particular, the documents should refer to the following topics: 1. Additional data obtained during construction on the site and its characteristics.

2. Description of the installation as it has been built, and the processes that will take place in it. The description of nuclear and non-nuclear instrumentation, control and protection systems, buildings or containment structures, auxiliary systems, systems for the collection and disposal of waste shall be included. radioactive, and any other system or component that is significant for the security of the installation. 3. The analysis of the foreseeable accidents resulting from the malfunction of elements and apparatus, of errors of operation, or of agents external to the installation and its consequences. 4. The installation's radiological analytical study. 5. The operational environmental radiological surveillance program, in order to assess the impact of the operation.

b) Operating Regulation. This document shall contain the following information: 1. Relationship of positions with nuclear responsibility, from the Director or Head of operation to the supervisors, operators, who are responsible for the radiological surveillance and execution of the tests. nuclear.

2. Organization. It shall specify the organisation and functions of the staff assigned to the facility under both normal and emergency conditions. It shall also describe the security management implemented. Basic training and training programmes for staff with and without a licence shall be defined and technical competence shall be established for each specific mission, as well as retraining programmes deemed appropriate. 3. Rules of operation under normal conditions and in conditions of accident. These rules and the procedures that develop them must refer to the whole of the installation and the various systems that make it up.

c) Technical specifications for operation. They shall contain the limit values of the variables affecting the safety, the limits of the performance of the automatic protection systems, the minimum operating conditions, the programme of checks, calibration and periodic inspections of systems and components, and operational control.

d) Internal emergency plan. It shall detail the measures envisaged by the operator and the allocation of responsibilities for dealing with the conditions of accident, in order to mitigate its consequences, protect the staff of the facility and notify its occurrence in a manner immediate to the competent bodies, including the initial assessment of the circumstances and the consequences of the situation. In addition, it shall establish the actions provided for by the operator to assist in the protection of the outside of the facility, in accordance with the external emergency plans to be established by the competent bodies, if so is determined by the Nuclear Security Council. (e) Nuclear test programme. It shall describe these tests, their object, the specific techniques and the expected results. For each test, the procedure to be followed shall be indicated, data to be collected in its performance and the maximum and minimum values foreseen for the variables of interest during the execution of the tests. It shall also include the applicable safety criteria for the performance of these tests. (f) Quality assurance manual. It shall establish the scope and content of the quality programme applicable to the testing and operation of safety-related systems, structures and components, as well as the design, manufacture, construction, testing and operation of the modifications of the same. (g) Manual of radiation protection. This document must include the radiation protection rules of the installation. (h) Plan for the management of radioactive waste and spent fuel, including, where appropriate, contracts established with management companies and include, inter alia, a system for the possible declassification of waste materials with radioactive content. (i) final economic study, which shall analyse the performance of the economic and financial forecasts, and shall express the total and actual amount of the facility. (j) Decommissioning and decommissioning checks. It shall describe, inter alia, those relating to the final management of the radioactive waste generated and the study of the cost and economic and financial forecasts to ensure the closure. k) Physical protection plan. It shall describe the organisational measures, equipment, systems and components, the aim of which is to achieve an acceptable level of physical security. It will have a confidential treatment. "

Five. Article 30 is worded as follows:

" Article 30. Request.

1. The application for a decommissioning authorisation shall be accompanied by the documentation referred to in Article 20 (b), (c), (d), (f), (g), (h) and (k), by adapting the content of the application to the decommissioning situation of the installation.

In any case, the provisions of the applicable environmental legislation must be complied with. Additionally it will be accompanied by the following documents:

a) Safety study, which will contain: 1. a descriptive study of the current state of the installation, the site and its area of influence, containing the radiological characterization of the installation and its location before of the dismantling.

2. General Decommissioning Project, containing the scope of each phase of the proposed decommissioning project, if there were several, as well as the description of the planned state of the installation during and after the development of the same. Significant activities and works likely to result in changes in the conditions of nuclear safety or radiation protection shall be specified for the stage for which authorisation is sought. 3. Safety analysis of the decommissioning project, which will contain applicable regulations and radiological and safety criteria, as well as an accident analysis, identifying the expected risks and prevention measures corresponding. 4. Study of the environmental radiological impact during the implementation of the decommissioning programme and after the completion of the decommissioning programme. It shall also contain an environmental radiological surveillance plan applicable during the implementation of the decommissioning programme.

b) Unclassifiable material control plan, which shall include the description of the processes and equipment used for the verification of compliance with the radiological criteria for the declassification of the materials waste generated.

c) Site restoration plan, which will include the proposal and justification of the methodology for the final radiological characterization of the site, with the objective of demonstrating compliance with the criteria (a) to be established for the total release, partial or with restrictions on the use of the site, and the means shall be proposed for establishing and maintaining the institutional legal controls to ensure compliance with the criteria; Radiation. (d) Economic study of the decommissioning process, financial investments and expected costs for decommissioning operations until the decommissioning.

2. The Nuclear Security Council shall define the scope, content or development of the documentation listed through technical instructions or guidelines or specific requirements. "

Six. Article 33 is worded as follows:

" Article 33. Closing statement.

1. Once the decommissioning activities have been completed, when compliance with the forecasts of the site restoration plan has been verified, as well as the other technical conditions laid down in the decommissioning programme, the The Ministry of Industry, Tourism and Trade will issue the closing statement, following the report of the Nuclear Security Council.

This Ministry, prior to the closing declaration, shall, for the purpose of making representations within one month, transfer to the Autonomous Communities corresponding powers in the field of management of the the territory and the environment in the territory of which the plant is located, in accordance with Article 28 of Law 25/1964 of 29 April on nuclear energy.

2. In those cases where necessary, the Ministry of Industry, Tourism and Trade, after a report by the Nuclear Safety Council, may agree to establish restrictions on the use of land on which the facility was established. (i) the closure of the nuclear power plant in accordance with Article 81.

Article 3. Amendment of Title III of the Regulation on nuclear and radioactive installations, approved by Royal Decree 1836/1999 of 3 December.

Title III of the Regulation on nuclear and radioactive installations, approved by Royal Decree 1836/1999 of 3 December, is amended as follows: Article 34 is worded as follows:

" Article 34. Definitions.

1. Radioactive installations: (a) installations of any kind which contain a source of ionizing radiation.

(b) Producers of ionising radiation operating at a potential difference of more than 5 kilovolts. (c) premises, laboratories, factories and facilities where radioactive materials are produced, used, owned, processed, handled or stored, except incidental storage during their transport.

2. Radioactive installations are classified into three categories. (a) First category radioactive installations are: 1. The uranium production plants, thorium and their compounds.

2. The production factories of natural uranium fuel elements. 3. installations using radioactive sources for industrial irradiation purposes. 4. The complex installations in which very high inventories of radioactive substances are handled or radiation beams of very high energy flow so that the potential radiological impact of the installation is significant.

For the purposes of this Regulation, radioactive installations of the nuclear fuel cycle are referred to as installations defined in paragraphs 1 and

.

b) Second category radioactive installations are, provided that their classification as a first category does not apply:

1. The facilities where radioactive nucleids are handled or stored that can be used for scientific, medical, agricultural, commercial or industrial purposes, the total activity of which is equal to or greater than a thousand times the values The exemption is set out in the IS-05 Instruction of the Nuclear Security Council.

2. Facilities using X-ray generating devices that can operate with a peak voltage of more than 200 kilovolts. 3. The particle accelerators and the facilities where neutron sources are stored.

(c) Third-category radioactive installations are: 1. The facilities where radioactive nuclides are handled or stored for which the total activity exceeds the exemption values laid down in the IS-05 Instruction of the Nuclear Security Council and less than a thousand times the same.

2. Facilities using X-ray generating devices with a peak voltage of less than 200 kilovolts. "

Two. Article 38 is worded as follows:

" Article 38. Applications.

1. Radioactive installations for scientific, medical, agricultural, commercial or industrial purposes shall apply for an operating authorisation. The application shall be accompanied by at least the following documentation: (a) The description of the installation. The site and construction details of floors, walls, ventilation and other similar elements shall be described.

Where appropriate, the choice of radionuclides or radioactive sources to be used in the installation and management systems of the solid, liquid and gaseous radioactive waste intended for the installation shall be justified. normal operation and in the event of an accident, incorporating contracts with management companies, re-export and other modalities, as appropriate in each case. b) Safety study. It shall consist of an analysis and assessment of the risks which may arise from the normal operation of the plant or because of an accident. Sufficient data shall be included in order to carry out an analysis of the risks of the installation, irrespective of the one presented by the applicant. c) Verification of the installation. Within the specific case of each case, a description of the tests to be submitted shall be included and, where necessary, the planned maintenance plan. (d) Rules of Procedure. The working methods and handling rules to ensure the safe operation of the facility shall be submitted. The applicable radiation protection measures shall also be described. It shall include the intended staff ratio, the planned organisation and the definition of the responsibilities corresponding to each job, both under normal operating conditions and in the case of an emergency. e) The internal emergency plan. It shall detail the measures envisaged by the operator and the allocation of responsibilities to deal with the accident conditions in order to mitigate its consequences, protect the staff of the facility and notify its occurrence in a manner immediate to the competent bodies, including the initial assessment of the circumstances and the consequences of the situation. In addition, it shall set out the actions envisaged by the operator to assist in the protection of the outside of the facility, in accordance with the external emergency plans to be established by the competent bodies, where appropriate. is determined by the Nuclear Security Council. (f) Forecasts for the closure and planned economic coverage to ensure the same under security conditions. (g) the economic budget of the investment to be made, which shall be constituted by the total and effective value of the radioactive installation or modification for which authorisation is sought, including all components which are their nature is affected by the operation of the same.

2. In the first category installations, the following shall also be attached: (a) Information about the location and surrounding land within the description of the site.

b) As part of the Operating Regulation:

1. The quality assurance and organization manual provided by the applicant to ensure quality during construction and operation.

2. Manual of Radiological Protection with the standards and procedures for radiation protection of the installation. 3. Technical specifications of operation containing the limit values of the variables affecting the safety, the limits of the performance of the automatic protection systems and the minimum operating conditions.

(c) Physical protection plan, which shall describe the organisational measures, components, equipment and systems, the objective of which is to achieve an acceptable level of physical security. It will have a confidential treatment. "

Three. Article 39 is worded as follows:

" Article 39. Granting and effects of the authorisation.

1. It is up to the Minister for Industry, Tourism and Trade to grant the operating authorisations, changes of ownership and the closing statements of the first category radioactive installations regulated in this chapter. The documents relating to the Autonomous Community shall be transferred to those authorisations, so that, within one month, they shall make representations in accordance with the provisions of Article 4 (2).

The granting of the remaining authorisations for radioactive installations covered by this Chapter corresponds to the Director-General for Energy Policy and Mines. 2. The operating authorisation of the radioactive facility empowers to its holder to carry out the assembly and preparation of the operations to be carried out, in accordance with the provisions of the rules in force and the conditions of the authorization. 3. Where the facility is in the position to commence operations, the holder shall communicate the fact to the Nuclear Security Council in order to enable it to carry out an inspection visit. Once the Nuclear Safety Council has estimated that the facility can operate under security conditions, it will issue a notification for the implementation, which will send the holder, giving the same account to the Ministry of Industry, Tourism and Trade. If the inspection of the Nuclear Safety Board would lead to the failure of the facility to meet sufficient nuclear safety or radiation protection guarantees and the anomalies would not be corrected by the holder of the authorisation within the time limit set The Commission shall inform the Ministry of Industry, Tourism and Trade in order to ensure that the measures taken are taken. 4. No radioactive installation regulated in this Chapter may commence its operation before notification for implementation, which shall entitle the holder to commence operations. "

Four. Article 40 is worded as follows:

" Article 40. Changes and modifications.

1. They shall require the authorization of the Ministry of Industry, Tourism and Commerce, following the same procedure expressed in Articles 38 and 39, the changes and modifications affecting the following aspects: (a) Entitlement to the installation.

b) Localization of the installation. (c) Activities to which the authorisation granted may be granted. d) Installation category. (e) Incorporation of new equipment accelerators that generate ionising radiation or modification of existing ones. (f) Incorporation of additional radioactive material, not previously authorised, with a total activity exceeding 3,7 GigaBekerelios; for lower activities, the provisions of paragraph 2 of this Article shall apply. (g) Changes in equipment and structural changes requiring a substantial modification of the conditions of the authorisation which may significantly affect nuclear safety and radiation protection.

The Nuclear Security Council will establish the criteria for determining when the modification requires a prior inspection and notification visit for the commissioning.

2. Changes and modifications affecting other aspects of the design or the authorised operating conditions of the facility shall only require the express acceptance of the Nuclear Safety Board prior to its implementation, informing this body to the Ministry of Industry, Tourism and Trade. 3. The other changes and modifications shall be free of charge by the holders, who shall inform the Ministry of Industry, Tourism and Trade and the Council of Nuclear Safety on the same, in the reports provided for in Article 2 (2). 73. 4. In addition to the above, in all cases the holder shall forward to the Ministry of Industry, Tourism and Trade and the Nuclear Safety Board the review of the documents referred to in Article 38 which are affected by the amendment. "

Article 4. Amendment of Title IV of the Regulation on nuclear and radioactive installations, approved by Royal Decree 1836/1999 of 3 December.

Title IV of the Regulation on nuclear and radioactive installations, approved by Royal Decree 1836/1999 of 3 December, is amended as follows: Article 44 is worded as follows:

" Article 44. Obligations of the holder.

1. The holder of a nuclear or radioactive installation shall be obliged to: (a) Facilitate the access of the inspectors to the parts of the installation which they deem necessary for the performance of their work.

b) Facilitate the placement of equipment and instrumentation that is required to perform the necessary tests and checks. (c) to make available to the inspectors the information, documentation and technical means necessary for the performance of their tasks. (d) Allow inspectors to take sufficient samples to carry out the relevant tests and checks. At the request of the holder of the authorisation, a duly sealed and marked witness sample shall be left in the possession of the authorisation holder. (e) Facilitate the access of inspectors to the work centres of suppliers of equipment and services related to the safety of the installation and the development of their activities within the scope of points (b), (c) and (d) above.

2. The obligations described in paragraph 1 (a), (b), (c) and (d) shall be extended to the person responsible for any establishment or place where the equipment for ionising radiation or radioactive material may be found. "

Two. Article 46 is worded as follows:

" Article 46. Actions in case of risk.

1. In the case of danger, the Ministry of Industry, Tourism and Trade, as well as the Nuclear Safety Board or its accredited inspectors, may, in the field of their respective powers, require the immediate cessation of the works, operation or operations, informing the Ministry of Industry, Tourism and Trade, giving an account of the causes of such action.

2. In the event of exceptional or emergency situations which arise and which may affect nuclear safety or radiation protection, where the Nuclear Safety Council has its origin in installations, equipment, undertakings or activities the provisions of this Chapter shall apply, not subject to the system of authorisations of nuclear legislation and may affect nuclear safety or radiation protection. '

Article 5. Amendment of Title V of the Regulation on nuclear and radioactive installations, approved by Royal Decree 1836/1999 of 3 December.

Title V of the Regulation on nuclear and radioactive installations, approved by Royal Decree 1836/1999 of 3 December, is amended as follows: Article 47 is worded as follows:

" Article 47. Licenses.

1. The personnel conducting the operation and operating the control and protection devices of a nuclear or radioactive nuclear fuel cycle installation shall be provided with a supervisor and operator's licence respectively, granted by the Nuclear Security Council.

In nuclear power plants, every maneuver is understood to affect the reactivity, the power level of the reactor or the integrity of the barriers against the release of radioactive material as shown in the procedures for operation. Core alterations, including fuel loading and unloading, and their transfer will only require supervision by a licensed person, who will not be simultaneously assigned other tasks other than the supervision of such activities. To this end, licences may be obtained exclusively for this purpose. 2. Except for the obligation to license those persons who, in the presence and under the direction of a licensed operator or supervisor, perform training practices as part of an operator training program or of supervisors. 3. In the case of decommissioning facilities, the Nuclear Security Council shall define the operation and supervision of systems as well as the handling of radioactive materials to be carried out or directed by personnel with license. Throughout the development of each phase of decommissioning, it will be possible to determine, depending on the remaining risks, the need for licensed personnel, as well as the type and number of the necessary licenses. 4. In the case of other nuclear facilities, the Nuclear Security Council shall define the activities to be carried out by the licensed personnel. 5. In addition, the nuclear facilities and the radioactive nuclear fuel cycle shall have a Radiological Protection Service, of which a person accredited to the effect with a diploma of Head of Service shall be responsible. Radiation protection issued by the Nuclear Safety Board. This requirement shall apply both at the operating stage of those installations and during the development of the active phases of their decommissioning. The need for a Radiological Protection Service in the inactive stages of decommissioning shall be determined, on a case-by-case basis, by the CSN, in the light of the radiological implications of the work being carried out in those phases. "

Two. Article 48 is worded as follows:

" Article 48. Characteristics of the licenses.

Operator and supervisor licenses for these facilities shall be personal and non-transferable, shall have a maximum validity period of six years and shall be specific to the installation in question, without being able to be used. in a separate other, unless expressly authorised by the Nuclear Safety Board. '

Three. Article 50 is worded as follows:

" Article 50. Processing of applications.

The application for the operator's or supervisor's license and the Head of the Head of the Radiological Protection Service shall be addressed to the Nuclear Safety Board and shall include the name, surname, nationality, document national identity or, in the case of foreigners, number of foreign identity, or, failing that, number of his passport or travel document, age and address of the applicant.

The request will be accompanied by the following documentation:

(a) Information on the applicant's academic and professional training and on his/her experience.

(b) The declaration of the holder of the installation in which the tasks to be assigned to the applicant and their favourable assessment of the suitability necessary for the performance of the tasks shall be recorded. (c) a medical certificate of fitness, issued by a service for the prevention of occupational risks, after the physical health and mental stability requirements have been analysed to carry out the activities of the job with a licence and those that involve risk of exposure associated with the job. "

Four. Article 52 is worded as follows:

" Article 52. Renewal.

Operator and supervisor licenses will be renewed for successive maximum periods of six years. To this end, the persons concerned shall apply for such renewals at least two months in advance of the expiry date of which they have been issued, together with a statement from the holder of the installation stating that: (a) They have been in the effectively and with due competence the specific missions of each license, fulfilling the conditions of active permanence in the post that are established in the technical regulations approved by the Council of Nuclear Safety.

b) They have continued to take advantage of the continued training program. (c) They shall remain qualified for the job with a licence, for a service for the prevention of occupational risks, in accordance with the terms laid down in Article 50 (c). "

Five. Article 53 is deleted.

Six. Article 54 is deleted. Seven. Article 55 is worded as follows:

" Article 55. Licenses.

1. Personnel handling material or radioactive equipment and directing such activities in a regulated facility in this section shall be provided with a specific licence granted by the Nuclear Safety Board.

2. There will be two classes of licenses:

(a) Operator's license, which enables the handling of material or equipment producing ionising radiation in accordance with pre-established procedures and instructions.

b) Monitor license, which enables you to direct and plan the operation of a radioactive installation and the activities of the operators.

3. Accreditations of personnel to direct and operate X-ray facilities for medical diagnostic purposes will be governed by the provisions of the regulations that are specifically applicable to this type of facility.

4. Licences granted by the Nuclear Safety Board shall be valid for the purposes of recognising training in safety and radiation protection, without prejudice to the qualifications and requirements which may be required in each case. and for reasons of the techniques applied. "

Eight. Article 56 is worded as follows:

" Article 56. Characteristics of the licenses.

1. The operator and supervisor licences for this type of facility shall have a minimum validity period of five years, shall be personal and non-transferable and specific per field of application. The Nuclear Safety Board shall establish the fields of application in which the activities of the licensed personnel are to be covered, on the basis of the various types of installation according to their purpose.

2. The Nuclear Safety Board shall maintain a register in which the operator and supervisor licences granted by application field and the installation to which they apply shall be entered. To this end, licence holders shall communicate to the Nuclear Safety Board the data on the premises in which they provide or in which they have a contract to provide their services. "

Nine. Article 60 is worded as follows:

" Article 60. Processing.

1. The application for licences and diplomas shall be addressed to the Nuclear Safety Board and shall include the name, surname, nationality, national identity card or passport number, age and address of the applicant.

2. The application shall be accompanied by the following documentation:

(a) Information on the applicant's academic and professional training and on his/her experience, in accordance with the modalities of accreditation provided for in the following article

b) Medical certificate of aptitude, issued by a service for the prevention of occupational risks, after the physical health and psychological stability requirements have been analyzed to carry out the activities of the job with a license and those that involve risk of exposure associated with the job. "

Ten. A new "Section 3. Term of the validity and suspension of licences and diplomas" is added in Title V, Chapter I, consisting of Articles 63, 63a and 63b, in the following terms:

" Section 3. Term of validity and suspension of licenses and diplomas Article 63. Term of validity.

Licences and diplomas for all types of nuclear and radioactive installations shall cease to be valid for the following reasons: (a) For expiry, if they have not been duly renewed.

(b) By revocation, after processing of the appropriate file, in the following cases, when they concern nuclear safety or radiation protection:

1. No substantial loss or decrease in the physical health or psychic stability of the holder, accredited with the corresponding medical certificates.

2. No to voluntarily submit to the test that is indicated to you by the holder or the Nuclear Safety Board to check your fitness conditions. 3. º By acting or serious omission, voluntary or negligent, in the performance of its functions. 4. The completion of the contractual relationship, in the case of licenses relating to nuclear and radioactive nuclear fuel cycle facilities.

(c) For the closure of the installation, in the case of licenses relating to nuclear and radioactive nuclear fuel cycle facilities.

d) By resignation of the license holder. (e) By disqualification from the relevant sanctioning file. (f) For any other circumstances in which, for safety reasons, it is deemed necessary, after processing the relevant file.

Article 63a. Suspension of licences and diploma.

The Nuclear Security Council may suspend licenses in the following cases: (a) For security reasons.

b) By loss of technical qualifications for the performance of their duties. (c) as a precautionary measure, where a sanctioning dossier has been initiated, if deemed appropriate. (d) Inactivity where the place of work for which the Nuclear Safety Board is established does not take place.

Article 63 ter. Necessary communications.

Any alteration of the physical or mental conditions of the holder of an operator or supervisor's licence or diploma which reduces the capacity and responsibility for the work must be formally communicated to the Council of Nuclear safety within a period not exceeding 15 days from the date on which it was detected. This communication must be carried out, if possible, by the person concerned. "

Once. Article 65 is worded as follows:

" Article 65. Supervisors and operators.

1. The supervisor is obliged to conduct the operation in compliance with the technical specifications for operation, the operating rules, the internal emergency plan and any other document under which the operation has been granted. corresponding to the approval of the installation, as regards the operation of the installation. It must also follow the procedures of operation, of which a copy, updated, must be permanently in place. Where there is no procedure to carry out a given operation of an unforeseen nature and which does not allow for delay, the supervisor shall draw up the procedure before it is carried out and shall include it in the operation journal. In case of urgency, it shall take such measures as it deems appropriate, with a record in that journal.

2. The operator is obliged to operate the control and protection devices, under the direction of the supervisor, in accordance with the procedures of operation, the technical specifications for operation, the operating rules and any other official document of the installation as regards the operation of the installation. '

Twelve. Article 66 is read as follows:

" Article 66. Obligations and powers.

1. The supervisor of a nuclear or radioactive installation has an obligation to stop at any time its operation if it considers that the proper safety conditions of the facility have been reduced.

2. The operator of a nuclear or radioactive installation is authorised to proceed in the same way if, in addition to the circumstances indicated above, it is impossible for him to inform the supervisor as soon as required. 3. Supervisors and operators are required to make known to the owner of the installation the defects which they believe exist in the official documents of the authorization or in the operating procedures or any other that may to affect nuclear safety or radiation protection through the procedure provided for in Article 8a. 4. Licensed personnel shall be required to know and authorize the work carried out at the facility, provided that they directly affect the operation of the installation. "

Thirteen. Article 67 is worded as follows:

" Article 67. Information to workers.

Any person working in a nuclear or radioactive installation must know and comply with the rules for protection against ionising radiation and his/her performance in the event of an emergency. In addition, all personnel carrying out tasks related to nuclear safety or radiation protection shall have the necessary training to perform their duties properly. To this end, the operator must clearly define the necessary knowledge and expertise and establish the training programmes that are required, which will be available for inspection by the Nuclear Safety Board. "

Article 6. Amendment of Title VII of the Regulation on nuclear and radioactive installations, approved by Royal Decree 1836/1999 of 3 December.

Title VII of the Regulation on nuclear and radioactive installations, approved by Royal Decree 1836/1999 of 3 December, is amended as follows: The current " Single Chapter. Authorization of other activities "shall constitute its" Chapter I ", with the same current name and integrated by Articles 74 to 80.

Two. Article 74 is worded as follows:

" Article 74. Radioactive materials, equipment, apparatus and accessories.

1. They shall require authorization from the Directorate-General for Energy Policy and Mines, subject to the report of the Nuclear Safety Board, without prejudice to the powers of other departments: (a) the manufacture of equipment, equipment and accessories incorporating radioactive materials or are generators of ionising radiation, even if the use thereof is included in the exemptions provided for in Annex I.

(b) The introduction into the Spanish market of consumer products incorporating radioactive materials, even if the use of such products is included in the exemptions provided for in Annex I. c) The placing on the market of materials radioactive materials and equipment, equipment, accessories or any other elements incorporating radioactive materials or generating ionising radiation, even if the use thereof is included in the exemptions provided for in Annex I, derogation from the consumer products referred to in point (b). (d) the transfer of radioactive materials without the holder to any authorised entity. In this case, the documentation referred to in paragraph 2 shall not be accompanied. (e) the technical assistance of radioactive devices and equipment generating ionising radiation.

2. The application for authorization shall be accompanied by the following documentation: (a) Identification of the company or entity: social reason, number of tax identification, domicile, certification of registration in the Trade Register and justification of the social object.

b) Memory of the activities to be developed. (c) Where appropriate, experience of the undertaking in activities of the same nature. (d) Organization of personnel and operating rules of the company. (e) The relationship of the technical staff of staff, with the expression of their qualifications, qualifications and professional experience. (f) Relation of the facilities, equipment and material means available to the company or entity to carry out its actions. (g) Where appropriate, procedures to ensure the radiation protection of workers exposed to the tasks to be carried out. 3. The importation, exportation and intra-community movement of radioactive materials shall be carried out in compliance with the international commitments made by Spain in this field. 4. Manufacturing, marketing and technical assistance undertakings which, by reason of their activities, need to have an authorised radioactive installation, may apply for a single authorisation. "

Three. Article 78 is worded as follows:

" Article 78. Record of carriers.

1. Carriers of radioactive materials, in non-excepted packages, must declare this activity by registering in a register which, for this purpose, will be established in the Directorate-General for Energy Policy and Mines called " Register of Carriers of Radioactive Materials. ' The development of the activity of transport of radioactive material must be adjusted, both to the regulation on the transport of dangerous goods and to the regulation on health protection against ionizing radiation and other nuclear legislation. applicable.

2. The companies carrying out the shipments under the contract of another registered carrier, acting as the person responsible for the initial compliance with the legislation applicable to the company, are exempted from the registration in that register. transport of radioactive material. 3. Such carriers must apply for registration in the aforementioned registration, by attaching the following documentation:

a) The entity's registered office.

b) Common transport types, frequencies and routes. c) Localization and characteristics of the facilities and dependencies that can be used for the reception, distribution and storage of radioactive materials in transit.

4. Carriers shall notify the register of any variations in the data reported.

5. The Directorate-General for Energy Policy and Mines shall communicate to the Nuclear Security Council and to the Ministry of Public Works any variation in the said register, for their knowledge and effects. "

Four. Article 80 is worded as follows:

" Article 80. Storage of spent fuel.

The containers used for the storage of spent fuel will require that their design has been approved by the General Directorate of Energy Policy and Mines, prior to the mandatory and binding report of the Council of Nuclear Safety. "

Five. A ' Chapter II is added. Contaminated Areas ", consisting of a single article, 81, with the following wording:

" CHAPTER II contaminated areas Article 81. Control of contaminated areas.

1. Public administrations or owners of installations or activities, whether or not they are subject to the system of authorisations provided for in this Regulation, shall bring to the attention of the Nuclear Safety Board any event of which the radiological contamination of land or hydrological resources is potentially derived.

2. Plans for the mitigation of effects or decontamination of the affected areas or hydrological resources which may be considered, the preparation of which will be the subject of the same, shall be submitted to the favourable opinion of the Council of Nuclear Safety. Following the corrective actions, the Nuclear Safety Board shall inspect and reassess the radiological conditions of the area, and may issue an opinion for the appropriate purposes, in which it shall be determined if the limitations of use are corresponding to those areas or resources concerned, giving the same to the Autonomous Community concerned. 3. The Nuclear Safety Board shall draw up an inventory of the land or water resources of which it has knowledge which has been affected by radiological contamination, informing the competent authorities of the effects of the "

Six. A ' Chapter III is added. Assessment, certification and validation of designs ', which is read as follows:

" CHAPTER III Appreciation, Certification and Convalidation of Designs Article 82. Appreciation of new designs or models.

1. Any person or entity may request the Nuclear Safety Board to issue a favourable assessment statement on new designs, methodologies, simulation models, or safety-related verification protocols. (a) nuclear protection or the radiation protection of the installations or activities covered by this Regulation, for which it shall submit an application to that body, together with the documents necessary to make such a declaration.

2. The declaration of the Nuclear Safety Council may be included as a reference in any subsequent process of application for any of the authorisations provided for in this Regulation, provided that the limits and conditions imposed in the statement.

Article 83. Certification and validation of new designs or models.

1. For the purposes of this Regulation, it is understood as: (a) Certification of conformity of a design: acceptance by the Nuclear Safety Board of its use in Spain.

(b) Convalidation of a design: acceptance by the Nuclear Safety Board of a certification of conformity or equivalent documentation issued by the competent authority on nuclear safety and security (a) radiolabelling from another country, the technical regulation of which is compatible with that applied in Spain.

2. Designs, generics or not, inter alia, of: (a) Nuclear fuel may be certified or validated.

b) Security analysis methodologies. c) Simulation models. (d) Verification protocols. e) Spent fuel storage containers.

3. Any natural or legal person may ask the Nuclear Safety Board for certification of conformity or the validation of a design. The application for certification or validation shall be accompanied by the following documents: (a) The description of the design to be certified or validated, justifying the intended use.

(b) Studies to ensure that the security conditions are met. (c) in the case of validations, documents certifying the certification of conformity or equivalent documentation. (d) any other than the applicant considers necessary in support of his/her application. "

Item seventh. Amendment of the final part and the Annexes to the Regulation on nuclear and radioactive installations, approved by Royal Decree 1836/1999 of 3 December.

The final part and the annexes to the Regulation on nuclear and radioactive installations, approved by Royal Decree 1836/1999 of 3 December, are amended as follows: One. The fourth additional provision is amended, with the following wording.

" Additional provision fourth. Environmental impact assessment procedure.

The environmental impact assessment procedure provided for in the Royal Legislative Decree 1/2008 of 11 January, approving the recast text of the Environmental Impact Assessment Act, will be entered into the substantive authorisation procedures covered by this Regulation. "

Two. A fifth transitional provision is added, with the following wording.

" Transient Disposition fifth. Period of adaptation to the new requirements.

The holders of activities and installations subject to the provisions of the Regulation on nuclear and radioactive installations, which upon the entry into force of this royal decree are in possession of a license or authorization in The Commission will be able to take the necessary steps to ensure that the new Member States will be able to take the necessary steps to ensure that they do not comply with the requirements of this Directive. requirements set out therein. '

Three. Annex I is worded as follows:

" ANNEX I Radioactive installations: classification and exemption

1. For the purposes of this Regulation, the following shall not be considered to be radioactive installations: (a) radioactive substances, if the activity does not exceed in total the exemption values indicated in the second column of Table A the IS/05 Instruction of the Nuclear Security Council.

(b) radioactive substances, if the mass unit activity does not exceed the exemption values indicated in the third column of Table A of the IS/05 Instruction of the Nuclear Safety Board. (c) the use of apparatus containing radioactive substances which exceed the activities or activity values per unit of mass specified in (a) or (b), provided that they correspond to a type approved by the Ministry of Industry, Tourism and Trade, as set out in Annex II. The approval resolution shall specify the conditions for its disposal. (d) the use of any cathodic tube intended to provide visual images or other electrical apparatus operating with a potential difference not exceeding 30 kV and electron microscopes, provided they do not present, under conditions normal operation, a dose rate of more than 1 µ Sv/h at no point at 0,1 m of the accessible surface of the apparatus. (e) the handling of devices emitting ionising radiation other than those referred to in point (d), provided that they correspond to a type approved by the Ministry of Industry, Tourism and Trade, as set out in Annex II. (f) Material contaminated with radioactive substances from authorised evacuations, which have been declared by the Ministry of Industry, Tourism and Trade, prior to the report of the Nuclear Safety Board, as not subject to controls later. (g) The Ministry of Industry, Tourism and Trade, following the report of the Nuclear Safety Board, may declare other practices exempt when, while exceeding the values of Table A of the Council of Nuclear Safety (IS/05) Instruction, meet the following conditions:

1. º The effective dose expected for any member of the public due to the exempt practice of the order of 10 µ Sv per year or lower, and

2. º The effective collective dose committed for each year of the execution of the practice does not exceed 1 Sv person, or an assessment of the optimization of the radiation protection shows that the exemption is the condition optimal.

2. The following rules shall be considered in the use of Table A of the IS/05 Instruction of the Nuclear Security Council: (a) Where necessary, the Nuclear Security Council shall assign appropriate values for the activities and activities per unit of mass in the case of radionuclides not collected in that table A. The values assigned in this way shall be complementary in relation to those in Table A.

(b) The nuclides with the suffix "+" or "sec" of the indicated table A represent the nucleid parents in secular equilibrium with their corresponding nucleid children listed in Table B of the Council of Nuclear Safety. In this case, the values given in that table A refer only to the parent nuclide, but they already take into account the nuclei (s) present. (c) In the other cases of mixing more than one nuclide, the exemption shall be maintained only if the sum of the ratios between the total active activity of each nuclide and the corresponding value shown in Table A of the IS/05 Instruction of the Nuclear Security Council is less than or equal to 1. This rule shall also apply to activities per unit of mass where the various nucleids concerned are contained in the same matrix.

3. For the purposes of the classification of radioactive installations in categories, as provided for in Article 34, the reference to the reference of the nuclide-free activity contained in the second column of Table A of Council Instruction IS/05 shall be considered as a reference (a) The facilities in which an activity exceeds the exemption activity and less than a thousand times is involved shall be of the third category.

(b) The second category is those in which the activity is equal to or greater than a thousand times the exemption. (c) In the case of a mixture of isotopes, if the sum of the ratios between the present activity of each isotope and the exemption is between one and a thousand, the installation shall be a third category and if it is equal to or greater than a thousand, second. "

Four. Annex II is worded as follows:

" ANNEX II Approval of types of radioactive devices General conditions

1. In order to approve the type of apparatus incorporating radioactive substances or generating ionising radiation, with a view to its exemption as a radioactive installation, the latter must provide sufficient safety against the leakage of ionising radiation, under normal conditions of use, as well as in other conditions which may be presented, including possible incorrect uses.

2. The apparatus shall have advantages which, in relation to its potential risk, justify its use. 3. The case of containing radioactive substances must be in the form of an encapsulated source in such a way as to ensure protection against any escape or leakage of the radioactive substance. 4. The apparatus shall not present under normal operating conditions a dose rate greater than 1 µ Sv/h at no point at 0,1 m of the accessible surface of the apparatus. 5. Approval of the type must be requested by the national manufacturer or, where appropriate, by the importer. For the type approval of a foreign-made appliance, it shall be specified that its manufacture or distribution is authorised in the country of origin or that it complies with the legal requirements in the country of origin, which shall be demonstrated with the appropriate supporting documentation. 6. The application for approval of the type shall be processed in accordance with Article 4 of this Regulation. A single type approval may be provided for equipment which is of the same manufacturer and for the same field of application, not being included in the same approval, apparatus incorporating radioactive substances with those which are Ionising radiation generators. The application shall be accompanied by the following documents:

(a) A supporting documentation that the applicant, in the case of domestic manufacturing, has a radioactive installation authorisation.

b) Documentation to enable full knowledge of the type to be approved. Such documentation shall contain at least:

1. Brand identification and model of the device.

2. The detailed description of the device and its security systems. Where appropriate, characteristics of the radioactive material and its encapsulation, and the possibility of access to it. 3. The supporting documentation showing the results obtained in the tests verified with the prototype, with respect to the conditions of radiation safety. 4. º Planes of the apparatus. 5. The use to which it is intended and expected useful life. 6. "Documentation" that the apparatus complies with the purpose for which it is intended. In the case of new practices, the use of the apparatus for non-radioactive alternatives shall be justified and an analysis of its advantages shall be provided against the potential risks involved. 7. Risk Analysis in situations that may be accidentally presented, including incorrect uses. In the case of devices fitted with radioactive material, the analysis shall consider access to the population for loss of control over the population. 8. "Manual of operation", in Spanish, to be delivered to users and to collect their technical characteristics and instructions for use, information about their risks and the basic recommendations for radiation protection to be considered during their use or, in their case, emergency, breakdown or break. 9. The maintenance programme, in Spanish, which includes, if necessary, the periodic checks which the manufacturer recommends to carry out on the systems or parameters affecting the safety of the apparatus, expressly stating those which, in The user will not be able to perform the risks.

(c) A proposal for the management of radioactive material shall be made at the end of its useful life for devices fitted with radioactive material. If this is the case, the proposal shall be supported by an analysis of the risks that such management may entail for the population. In the event of the withdrawal by the supplier of origin, an original document issued by the supplier shall be provided to ensure that the withdrawal is made.

(d) Supporting documentation of the quality assurance standards applied by the manufacturer of the ionising radiation producing apparatus. (e) in the case of domestic manufacture, authorization for the manufacture of ionising radiation producing equipment. (f) In the case of imported goods, the Directorate General for Energy Policy and Mines or the Nuclear Safety Board may require the translation into the Spanish language of the documentation deemed necessary, endorsed by the consulate of Spain in the country of origin.

7. The Nuclear Safety Board, after receiving the copy of all the documentation, shall issue its technical opinion on security, for which it may request the petitioner, if it considers it necessary, any clarifications it deems necessary.

8. The opinion of the Nuclear Security Council, together with the clarifications that the petitioner has provided, will be referred by the agency to the Directorate General for Energy Policy and Mines. 9. Having received the opinion of the Nuclear Safety Board, the Directorate-General for Energy Policy and Mines shall adopt the appropriate resolution. 10. The Directorate-General for Energy Policy and Mines, in the resolutions approving rates, shall describe the characteristics of the type, the use for which it is accepted and the conditions and obligations to which it is submitted and the number of It is the right to impose new conditions. The abovementioned resolutions shall be published in the Official Gazette of the State. 11. The Directorate-General for Energy Policy and Mines, acting on a proposal from the Nuclear Safety Board, may require the importer or national manufacturer to carry out tests or tests on certain supplied units, which are intended to check which maintain the security conditions of the approved type. In the event that deviations are detected, the General Directorate for Energy Policy and Mines may cancel the approval of the type. 12. The Spanish manufacturer or the importer of an apparatus with the approved type shall supply the following documentation with each copy:

(a) A certificate stating: 1. The serial number of the apparatus and its date of manufacture.

2. º Declaration that the type has been approved by the Directorate General of Energy Policy and Mines, pointing out the approval number and the date of the resolution and the "Official State Gazette" in which it has been published. 3. ° The apparatus corresponds exactly to the approved type. 4. No. Use for which you have been authorized. 5. The treatment or destination of the apparatus and, where appropriate, of the radioactive substance it contains, at the end of its useful life. 6. º Any other information set forth in the type approval.

b) Specifications and conditions set out in the type approval.

c) Manual of operation in Spanish. (d) Any other documentation provided for in the type approval.

13. The devices producing ionising radiation to be supplied shall be marked as laid down in the relevant approval of the type.

14. The user of the apparatus is obliged to respect the conditions imposed by the General Directorate of Energy Policy and Mines in the resolution approving the type. "

Single repeal provision. Regulatory repeal.

As many provisions of equal or lower rank are repealed, they oppose the provisions of this royal decree.

Final disposition first. Competence title.

This royal decree is issued in accordance with the provisions of Article 149.1.16. and the 25th of the Constitution which attribute to the State the competence on the bases and general coordination of the health and bases of the mining and energy regime, respectively.

Final disposition second. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, on January 18, 2008.

JOHN CARLOS R.

The Minister of Industry, Tourism and Trade, JOAN CLOS I MATHEU