The Regulation on existing nuclear and radioactive installations was approved by Decree 2869/1972 of 21 July. Since that date, a number of rules have been published which have changed the frame of reference in which the various bodies of the administration were to act. In particular, the enactment of Law 15/1980 of 22 April establishing the Nuclear Safety Council, which is the only body responsible for nuclear safety and radiation protection, makes the revision necessary. full of the text approved in 1972.

The establishment of the State of the Autonomies and the transfer to these of functions and services, the incorporation of Spain to the European Communities, the enactment of Law 21/1992, of 16 of In July, Industry, Law 6/1997, April 14, Organization and Operation of the General Administration of the State, which integrates territorial services of the General Administration of the State in the delegations of the Government, as well as of the Law 30/1992, of 26 November, of the Legal Regime of the Public Administrations and of the Common Administrative Procedure, as amended by Law 4/1999 of 13 January, and the publication of the Royal Legislative Decree 1302/1986 of 28 June on environmental impact.

With respect to the nuclear facilities the main modifications introduced are the adequacy of the documentation required in the different phases of authorization, the replacement of the successive extensions of the permits provisional holding by means of holding authorisations subject to the deadline and the regulation of the processing of decommissioning and decommissioning authorisations.

The determination of the documentation required in the various authorizations has been made on the basis of the evolution of the security requirements in the years of validity of Decree 2869/1972 of 21 July, for which it is approved the regulation to be repealed, and which have been established on a case-by-case basis in the Resolutions of the Ministry of Industry and Energy and, since its constitution in 1981, by the Nuclear Security Council.

With regard to the replacement of successive extensions of provisional operating permits, the regulation to be repealed was a consequence of the lack of experience in the operation of nuclear power plants in our country. had in 1972. As a precaution, the legislator then introduced the provisional operating permit, as an alternative to the granting of the definitive operating permit, in order to allow the control bodies of the Administration to have a period of time which allow you to obtain the basic data to evaluate the security of the installation. Experience, national and international, in this field determines the desirability of replacing these permits with an operating authorisation, subject to a period of validity, which is only provisional during the time necessary for the execution of the nuclear test programme.

The Regulation that is repealed lacked forecasts for the decommissioning phase and the decommissioning of nuclear and radioactive installations, so it is appropriate to develop in the text that the entire procedure is approved and the documentation to be provided by the holders.

Another modification, which particularly affects waste storage facilities, nuclear reactors and critical assemblies for research, is the inclusion of the need to obtain authorization. prior to this, as it is obvious, from experience and as a result of the legislation on environmental impact statements, that these facilities are to be subject to the whole regulatory process, as well as the rest of the nuclear facilities.

With respect to radioactive installations, two have been the main modifications that have been introduced. One has been derived from the application of the European Union legislation, and in particular from Council Directive 96 /29/EURATOM of 13 May laying down the basic rules for the protection of the health of workers and workers. population against the risks arising from ionising radiation, in which the activities of radionuclides exempt from administrative control are updated, which affects the classification of these installations into categories and to the exempt facilities and activities.

The second amendment concerns the administrative procedure for these installations, which is now graduated in a different way from the one covered by the Regulation which is repealed. For the radioactive nuclear fuel cycle facilities, the same processing and documentation required for nuclear installations has been foreseen.

For all other radioactive installations, processing is greatly simplified by reducing to a single request that results in an operating authorization.

The need to obtain manufacturing authorization is reduced to those equipment that incorporate radioactive materials or are producers of ionising radiation.

With regard to the approval of types of ionising radiation producing apparatus for use as radioactive waste authorisation, in Annex II, the rules laid down in Annex II are updated and revised. in the Order of 20 March 1975, bringing it into line with the provisions of this type of exemption in the European Union Directive.

The text of the Regulation is incorporated into the text of the Regulation concerning the authorizations of the sales and technical assistance companies in the field of radioactive installations, extending the precepts established in Royal Decree 1891/1991, of 30 December, and the provisions which complement it, concerning the facilities for radiodiagnosis.

The need for registration is also incorporated in a Register to be established in the General Directorate of Energy for the carriers of nuclear substances and radioactive materials.

Finally, it should be noted that the draft of this provision has been communicated to the Commission of the European Union in accordance with Article 33 of the Treaty establishing the European Energy Community. Atomic (EURATOM).

In its virtue, on the proposal of the Minister of Industry and Energy, in accordance with the Regulations proposed by the Nuclear Security Council, with the prior approval of the Minister of Public Administrations, according to the Council of State, and after deliberation by the Council of Ministers at its meeting on 3 December 1999,

DISPONGO:

Single item. Regulation on nuclear and radioactive installations.

The Deputy Regulation on nuclear and radioactive installations is hereby approved.

REPEAL PROVISION

Unica. Regulatory repeal.

Decree 2869/1972 of 21 July 1972 on the approval of the Regulation on nuclear and radioactive installations; the Order of the Ministry of Industry of 20 March 1975 on the type-approval of equipment radioactive, as well as all standards of equal or lower rank in which they contradict or object to the provisions of this Royal Decree.

FINAL PROVISIONS

First. Development of the precepts.

The Minister of Industry and Energy is hereby authorised to approve the provisions necessary for the implementation and development of the provisions of this Regulation.

The Nuclear Safety Board may issue guidelines or technical standards to facilitate the implementation of this Regulation.

Second. Basic character.

This Regulation is of a basic standard and is dictated by the provisions of Article 149.1.16.a and 25.a of the Constitution.

Third. Entry into force.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Given in Madrid at December 3, 1999.

JOHN CARLOS R.

The Minister of Industry and Energy,

JOSEP PIQUE I CAMPS

REGULATION ON NUCLEAR AND RADIOACTIVE INSTALLATIONS

TITLE I

General provisions

ONLY CHAPTER

Application of the Regulation

Article 1. Object.

This Regulation aims to regulate the system of administrative authorisations for both nuclear and radioactive installations and for other specific activities related to the application of radiation. ionising. It also integrates the system of accreditation of staff, the obligations of the holders of such facilities and the inspection and control activities. All this in accordance with Law 25/1964 of 29 April on Nuclear Energy and Law 15/1980 of 22 April establishing the Nuclear Safety Council and with the provisions of the Community legislation and national legislation on nuclear safety. projects submitted for environmental impact assessment.

Article 2. Competent authorities.

1. The application of the provisions of this Regulation corresponds to the Ministry of Industry and Energy, and to 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 and Energy, in relation to the second and third category of radioactive installations, shall be understood to be attributed to the Autonomous Communities when they have the transferred these functions.

3. The operating authorisations referred to in the second and third category of radioactive installations shall be valid for the entire field of the State, but the holder who is to act or has a delegation in the territory of a Competent administration in respect of installations of the second and third categories other than the one authorized by the authorization shall notify the competent authority of that territory, and may, on the basis of that notification, initiate its activity. The notification shall be accompanied by a certified copy of the authorisation and conditional approval.

It is understood that there is no opposition to the foregoing if the competent authority in that territory did not manifest such opposition, by means of a reasoned decision, within three months from the date of notification.

Article 3. Recording of radioactive installations.

1. All authorized installations will be registered in the "Register of Radioactive Facilities" attached to the Directorate General of Energy. The Ministry of Industry and Energy shall regularly submit information on the content of the register to the competent bodies.

2. The Autonomous Communities shall communicate to the Ministry of Industry and Energy, at least once a month, the authorizations they have granted, and may, within their territory and within the scope of their powers, establish their own records.

Article 4. Submission of requests.

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

If the Ministry of Industry and Energy 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 forward a copy of all documentation to the Nuclear Safety Board for its mandatory report.

Article 5. Renewal of the authorizations.

1. The renewal of the authorisations shall be carried out by means of the same procedure for which they were granted, together with the updating of the supporting documents or, where appropriate, the documentation to be determined for each authorization.

2. In the case of renewal of authorisations for nuclear installations, the report of the Nuclear Safety Board shall be forwarded to the Ministry of Industry and Energy at least one month before the expiry date of the current authorisation.

Article 6. Mandatory reporting.

1. The reports of the Nuclear Safety Council for the granting of authorisations for nuclear and radioactive installations and for the manufacture of ionising radiation-generating equipment, equipment or accessories shall in any event be required and, in addition, binding when they have a negative or a refusal of a concession and, in addition, as regards the conditions which they lay down, if they are positive.

2. The procedures in which such reports are to be issued may be suspended by the body responsible for its resolution, exceptionally, for an indefinite period up to the issue of such reports or for the period of time considered. appropriate for these to be issued, justifying the suspension.

3. The authorisations or licences to be granted to any public administration may not be refused or conditioned for reasons of nuclear safety or radiation protection, the assessment of which corresponds to the Nuclear Safety Board.

4. The Nuclear Safety Board may, in the field of its powers, send directly to the holders of the authorisations additional technical instructions to ensure that the conditions and safety requirements of the Directive are maintained. the facilities and for the best compliance with the requirements set out in the relevant authorisations.

5. The Nuclear Safety Council may paralyse the works in the event of anomalies affecting nuclear safety and until these are corrected, and may propose the annulment of the authorization if the anomalies are not susceptible. to be corrected. Similarly, it has the authority to suspend, for reasons of nuclear safety and radiation protection, the operation of the facilities or the activities to be carried out.

6. The Nuclear Safety Board may require additional documentation which it considers necessary in relation to nuclear safety and radiation protection and, prior to the studies and assessments carried out, shall issue the relevant report. (a) security technician who shall forward to the Ministry of Industry and Energy.

Article 7. Granting of authorizations.

The Ministry of Industry and Energy, 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 that empower you to perform the granted authorization.

d) Term of validity and conditions for renewal, where applicable.

e) Purpose of the installation and, where appropriate, basic characteristics of the installation.

(f) Where applicable, nuclear substances and other material and equipment producing ionising radiation the possession or use of which is authorised.

g) Official operating documents on the basis of which the authorisation and processing necessary for their review are granted.

h) Requirements for personnel licenses for the operation of the installation.

i) Guarantees that the holder has to agree on civil liability for nuclear damage to third parties.

j) Limits and conditions in the field of nuclear safety and radiation protection.

k) Other conditions that might suit the case.

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 operating documents. It is responsible for the implementation and updating of such documentation, to inform the Ministry of Industry and Energy and the Nuclear Safety Council of how many issues may affect the conditions of the authorisation or of nuclear safety and radiation protection and, in general, to comply with existing regulations. The operator shall also be responsible for the installation in the emergency situations that may occur.

2. With regard to safeguards and the physical protection of nuclear materials, the holder shall be obliged to carry out the monitoring, control and custody activities of such materials, to allow for the inspections and checks to be carried out, 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.

Article 9. Risk coverage.

1. In no case shall the admission of nuclear or other radioactive materials or the operation of nuclear and radioactive installations be permitted without the guarantee of the coverage of nuclear risks, in accordance with the provisions of this Directive. in effect.

2. Pursuant to Article 57 of Law No 25/1964 of 29 April 1964 on Nuclear Energy, the second and third category of radioactive installations shall not require the provision of the risk cover referred to in that Article. This exemption shall also apply to X-ray producing devices for medical diagnosis purposes.

3. Any variation, suspension or cancellation of the nuclear risk coverage shall be communicated immediately by the operator to the Directorate-General for Energy and to the Nuclear Safety Board, the Directorate-General being the determine how to proceed in each case.

Article 10. Violations.

The infringements of the precepts contained in this Regulation shall be sanctioned in accordance with the provisions of Chapter XIV of Law 25/1964 of 29 April of Nuclear Energy, as amended by the additional provision fifth of Law 54/1997 of 27 November of the Electrical Sector.

TITLE II

Of Nuclear Facilities

CHAPTER I

Classification and authorizations

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 to produce nuclear substances and the factories in which the treatment of nuclear substances is carried out, including facilities for the treatment or reprocessing of fuels irradiated nuclear.

(d) Storage facilities for nuclear substances, except where such substances are stored incidentally during their transport.

Article 12. Required authorizations.

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 authorization: entitles the holder to begin construction of the facility and to apply for the operating authorization.

(c) Operating authorisation: entitles the holder to charge 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 established in the authorisation. It shall be granted on a provisional basis until the satisfactory completion of the nuclear tests.

Also, this authorization entitles the holder, after the operation for which the installation was conceived, to perform the operations that the Administration imposes prior to obtaining the authorization of decommissioning.

(d) Authorisation of modification: entitles the holder to make modifications to the design of the facility or its operating conditions, in cases where the criteria, rules and conditions on which the plant is based are altered. exploitation authorisation or involving a significant change of equipment.

e) Authorization of execution and assembly of the modification: it empowers the holder to initiate the realization, execution and assembly of those modifications which, by its great scope or because it involves significant works and assemblies, consider it necessary to expressly authorise, in the opinion of the Directorate-General for Energy or the Nuclear Safety Board.

(f) Decommissioning authorisation: after the authorisation of the holding has been extinguished, the holder shall have the right to initiate decontamination, disassembly of equipment, demolition of structures and removal of materials, for allow, ultimately, 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 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 nuclear facilities, in any case.

The authorisations provided for in the previous 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 paragraphs (b) and (d) of Article 11 of this Regulation may apply for prior and construction authorization at the same time. This will also apply to the generic designs of nuclear power plants approved by the Ministry of Industry and Energy, prior to the report of the Nuclear Safety Board.

3. It is for the Minister for Industry and Energy to grant the authorisations referred to in paragraph 1 of this Article, except those referred to in paragraphs (1) (d), (e) and (g), which correspond to the Director-General of Energy.

Article 13. Information committee.

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. The members of the Committee shall be appointed by the Director-General of Energy. He shall be chaired by a representative of the Ministry of Industry and Energy and shall be composed of a representative of the holder of the installation, the Nuclear Safety Board, the delegations of the Government, the Autonomous Communities and the Municipalities in the territory of which the installation is located. They may also be part of the same other representatives of public administrations, where the nature of the cases to be dealt with so requires.

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.

CHAPTER II

Prior authorization

Article 14. Request.

The prior authorization request will be accompanied by the following documentation:

a) Statement on the needs to be met, the justification for the installation and the location chosen.

b) Descriptive memory. This memory shall consist of a description of the key elements of the installation and shall, in general, include the basic information on the installation, the technology to be used, the previous supply plan and the forecast for the decommissioning.

c) Preliminary construction project. Phases and deadlines for implementation. Prior economic study on the expected financial investments and costs.

d) Study of site and influence area characterization of the facility, including sufficient data on site parameters that may have an impact on nuclear safety or protection radiological, including those of a demographic and ecological nature, as well as activities related to spatial planning.

e) Organization planned by the applicant to monitor the project and ensure quality during construction.

f) Description of the activities and preliminary works of infrastructure that are intended to be carried out after prior authorization has been granted and before applying for the construction authorization.

Article 15. Processing.

1. Upon receipt of the request for prior authorization, the Ministry of Industry and Energy shall transmit a copy thereof to the respective Government Delegation to open a period of public information, which shall be initiated with the publication in the "Bulletin". Official of the State " and in that of the corresponding Autonomous Community of an extract announcement in which the object and the main characteristics of the installation will be highlighted. The notice shall state that the persons and entities deemed to be affected by the project may submit, within 30 days, to the Delegation of the Government concerned, the written submissions they consider to have been made.

2. The processing of public information shall be carried out jointly with that provided for in the environmental impact study in its specific regulation.

3. After 30 days of public information has expired, the Government Delegation shall carry out the relevant checks, both as regards the documentation submitted and the written submissions, and shall issue its report in respect of one and others, sending the file to the Ministry of Industry and Energy and copies it to the Nuclear Security Council.

Article 16. Reports.

The Ministry of Industry and Energy, before granting the appropriate authorization, will seek to inform the other public administrations and institutions concerned, as well as other ministries, provided that the nature of the such authorization requires it.

CHAPTER III

Build Authorization

Article 17. Request.

The build authorization request will be accompanied by the following documentation:

a) General installation project.

b) Procurement programme, which shall contain a list of the elements and equipment and their source.

c) Budget, financing, execution time and technical collaboration regime.

d) Economic survey, which will be updated by the application for prior authorisation.

e) Preliminary security study, which you must understand:

1. Description of the site and its surrounding area, with current data on the parameters that have an impact on nuclear safety and radiation protection, including demographic, ecological and land and water uses, and how much data can contribute to a better understanding of the data, as well as the monitoring and verification plans of the site's representative basic parameters.

2. The installation description, including the criteria followed in the design of those components or systems that the installation security depends on.

3. th Analysis of foreseeable accidents and their consequences.

4. The radiological analytical study, which theoretically estimates the potential radiological impact of the installation on the population and the environment.

5. The organization's planned update to monitor project development and ensure quality during construction.

6. Organization planned for the future exploitation of the installation and preliminary training program of the operating personnel.

7. The pre-operational environmental radiological surveillance program, based on the conclusions obtained in the radiological analytical study, which allows the establishment of the reference level or radiological background of the area monitored.

8. Construction Quality Assurance Program.

f) Technological, economic and financing of decommissioning and decommissioning.

g) Administrative concessions and authorizations, to be granted by other Ministries and Public Administrations, or the supporting documents to have been requested with all the necessary requirements.

Article 18. Prenup tests.

During the construction and assembly of nuclear facilities, and before proceeding to the nuclear fuel load or to the admission of nuclear substances in the facility, the holder of the authorization is obliged to carry out a rolling test programme which shall include the tests, verifications and checks to be carried out on the different systems of the installation.

The aim of such a programme of practical tests is to demonstrate the appropriate behaviour of the equipment or parts of the installation, both in relation to nuclear safety and radiation protection and with the industrial and technical regulations applicable.

Article 19. Approval and execution.

1. The programme of prenuclare tests shall be proposed by the holder of the authorisation. This programme, as well as the technical conditions of each test, must be approved prior to its implementation by the Directorate-General for Energy, after the report of the Nuclear Safety Board.

2. The execution of the tests and verifications shall be carried out under the responsibility of the holder of the authorisation. The procedures to be carried out, as well as the results obtained, shall be duly documented. The Directorate-General for Energy, after the report of the Nuclear Safety Board, shall, within the framework of the programme of tests, indicate the tests and verifications to be carried out in the presence of the inspection of the Security Council. Nuclear and the Ministry of Industry and Energy.

3. The results of the prenup tests shall be submitted to the Directorate-General for Energy and to the Nuclear Safety Board for analysis before the exploitation authorisation can be granted.

CHAPTER IV

Operating authorization

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) Security 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 assessment of the risks arising from the operation of the facility, both under normal conditions and in conditions of accident. 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 to the security of the installation.

3. º Analysis of the foreseeable accidents arising 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 of the program.

b) Operating Regulation. This document will contain the following information:

1. The 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 the execution of the nuclear tests.

2. Organization. It shall specify the organisation and functions of the staff assigned to the facility, both under normal and emergency conditions. 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. Standard operating rules under normal conditions and in accident conditions. These standards and the procedures that develop them should refer to the set 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 program. 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 security 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, incorporating, where appropriate, contracts established with management companies and including, inter alia, a system for its possible declassification.

i) Final economic study, which will analyze the performance of economic and financial forecasts, and will express the total and effective amount of the facility.

j) decommissioning and decommissioning checks, where the intended final disposal of the generated waste will be exposed and the cost and economic and financial forecasts to be included in order to ensure the closure.

Article 21. Nuclear tests.

1. The operating authorisation shall be granted on a provisional basis for the time necessary to carry out the nuclear test programme and to analyse its results.

2. The nuclear test programme shall include the set of tests, verifications and checks to be carried out on each of the different systems consisting of the installation, from the time of the initial loading of the nuclear fuel or from the The introduction of nuclear substances into the same and to achieve full operability, including those that must be carried out in nuclear power plants and reactors to one hundred percent of the authorized thermal power.

It shall be applicable to the implementation of the nuclear testing programme as set out in Article 19.

3. The official representation of the Nuclear Security Council during the conduct of the tests is entitled to suspend at any time its execution when, in its judgment, its continuation is potentially dangerous. In such a case, the Nuclear Safety Board shall adopt the measures which it shall take, taking into account the Directorate-General for Energy.

Article 22. Test result.

After completion of the nuclear test program, the holder of the authorization shall forward to the General Directorate of Energy and the Nuclear Safety Board:

a) Results of the nuclear test program.

b) Proposal for amendments to the technical specifications of operation, if it is considered advisable to incorporate them as a result of the tests carried out.

Article 23. Grant.

The Nuclear Safety Board shall report to the Ministry of Industry and Energy, both on the results of the tests and the modifications which, if necessary, should be made, and on the conditions of the renewal of the operating authorisation for the period to be established.

The Ministry of Industry and Energy will then issue the new operating authorisation for the appropriate period.

Article 24. Modifications of the conditioned.

The Directorate-General for Energy, either on its own initiative or on a proposal from the Nuclear Safety Board, within the scope of its respective powers, may require the holder of an operating authorisation to introduce new conditions or the alteration of those already imposed in the condition of the current authorization.

CHAPTER V

Installation modifications

Article 25. Modification of installations.

1. Modifications to the design, or operating conditions, affecting the nuclear safety or radiation protection of an installation, as well as the testing of the installation, shall be analysed in advance by the operator for verify whether the criteria, rules and conditions on which the authorisation is based are still satisfied.

If the analysis carried out by the operator concludes that the requirements listed in the previous paragraph continue to be guaranteed, the latter may carry out the modification or tests, reporting periodically on its performance to the Ministry of Industry and Energy and the Nuclear Safety Council.

If the design modification involves an amendment of criteria, rules and conditions on which the operating authorisation is based, the operator shall ask the Ministry of Industry and Energy for an authorisation to modification, which will have to be effective prior to the entry into service of the modification or to the performance of the tests.

2. Irrespective of the authorization referred to above, where, in the opinion of the Directorate-General for Energy or the Nuclear Safety Board, the amendment is far-reaching or involves significant construction or assembly works, the General Energy will require the holder to request an authorization to execute and mount the modification. In no case shall it be possible to carry out assembly or construction activities of this type of modification prior to the granting of the corresponding authorisation.

3. The operator shall inform, at the intervals specified in Title VI of this Regulation, the Directorate-General for Energy and the Nuclear Safety Board of the proposed modifications, implemented or in course of implementation, and of the analyses security of the same.

Article 26. Request for authorization.

The modification authorization request will be accompanied by the following documentation:

a) A technical description of the modification identifying the causes that have motivated it.

b) The security analysis performed.

c) An identification of the documents that would be affected by the modification, including the proposed text for the safety study and the technical specifications of operation, when applicable.

d) Identification of pre-restart tests of the operation that are required to be performed.

Article 27. Documentation for the execution and mount authorization.

The application for authorisation for the execution and assembly of the amendment, where it is due pursuant to Article 25, shall be accompanied by the following documentation:

a) Overview of the modification, identifying the causes that have motivated it.

b) Regulations to be applied in the design, construction, assembly and testing of the modification.

c) The basic design of the modification.

d) Planned organization and quality assurance program for project implementation.

e) Identification of the scope and content of the analyses necessary to demonstrate the compatibility of the modification with the rest of the facility and to ensure that the safety levels of the plant are maintained. same.

f) The target of the equipment to be replaced, if any.

g) Acquisition and budget plan in case of major modifications.

Article 28. Cessation of operation.

1. The holder of an operating authorization shall communicate to the Ministry of Industry and Energy, at least one year before the date of the planned date, his intention to terminate the activity for which the installation was conceived. Both in this case, and when the cessation of the activity is due to some other circumstance, the Minister of Industry and Energy, prior to the report of the Nuclear Safety Council, will declare the final cessation of the operation and establish the the conditions to which the activities to be performed at the facility are to be adjusted until the decommissioning authorisation is obtained and the period within which such authorisation is to be requested.

2. The holder of the operating authorisation, prior to the granting of the decommissioning authorisation, shall:

(a) To have discharged the fuel from the reactor and the storage pools or, in the absence of the latter, that a plan of management of the spent fuel approved by the Ministry of Industry and Energy is available, Report of the Nuclear Safety Board.

b) Haber the waste generated during the operation.

CHAPTER VI

Decommissioning authorization and closing declaration

Article 29. Required authorizations.

The decommissioning of a nuclear facility will require decommissioning authorization and closing declaration.

For the purposes of this Regulation, the whole of the activities carried out after obtaining the corresponding authorisation, which allow the closing declaration to be requested and which will be the same, will be understood as dismantling. declassification of the installation and the total or restricted release of the site.

Article 30. Request.

The decommissioning authorization request will be accompanied by the following documentation:

a) Security study, which will contain:

1. A descriptive study of the current state of the facility, site and its area of influence.

2. General Decommissioning Project, containing the radiological characterization of the installation and site, the proposed decommissioning scope and the description of the intended state of the installation during and after the execution of the same.

3. Safety Analysis of the Decommissioning Project, which will contain the safety criteria, applicable regulations and an accident analysis, identifying the expected risks and prevention measures corresponding.

4. Study of the environmental radiological impact of the implementation of the decommissioning programme, which shall contain the applicable environmental radiological surveillance plan.

(b) Operating Regulation, which shall contain the organisation and the rules of action, both under normal conditions and in the event of an accident.

c) Technical specifications applicable during the decommissioning phase.

d) Quality Assurance Manual.

e) Radiological protection manual.

f) 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.

g) Plan for the management of radioactive waste that will contain its inventory, characterization, treatment, conditioning and storage as well as the criteria adopted for the declassification of materials.

h) The site restoration plan, which will include, where appropriate, plans for monitoring the levels of radiation and contamination of the site to be released.

i) Economic study of the decommissioning process and financial forecasts to address it.

Article 31. Ownership of the decommissioning.

If the holder of the decommissioning activities is to be different from the holder of the operating authorisation, it shall be the person who submits the relevant application. The transfer of ownership shall be authorised in conjunction with the decommissioning authorisation and, on a prior basis, the holder of the holding authorisation shall have complied with the conditions laid down in Article 28 of this Regulation.

Article 32. Content of the authorization.

The decommissioning authorisation shall include the general approach of the decommissioning authorisation and, if it is carried out at different stages, the decommissioning authorisation shall only regulate the activities envisaged in the implementation phase. immediate, with the holder requesting a new authorisation for the development of the successive phases.

Article 33. Closing statement.

Once the decommissioning activities have been completed, when the forecasts of the plan for the management of the radioactive waste generated have been met and the Nuclear Safety Council has been found to have reached the technical conditions set out in the decommissioning programme, the Minister for Industry and Energy shall issue the closing statement, following the report of the Nuclear Safety Board.

TITLE III

From radioactive installations

CHAPTER I

Defining, sorting, and authorizations

Article 34. Definitions.

1. It is understood by radioactive installations:

a) Facilities of any kind that contain a source of ionizing radiation.

(b) Producers of ionising radiation operating at a potential difference of more than 5 kV.

(c) premises, laboratories, factories and facilities where radioactive materials are produced, used, owned, processed, handled, handled or stored, except incidental storage during their transport.

2. The radioactive installations are divided into three categories, as provided for in the first provision of Law 15/1980 of 22 April of the creation of the Nuclear Safety Council, considering the activity exempted by the nuclide of the second column of Table A of Annex I to this Regulation for the second and third category installations.

For the purposes of this Regulation, radioactive installations of the nuclear fuel cycle shall be called:

a) The uranium production factories, thorium and their compounds.

b) Production factories of natural uranium fuel elements.

Radioactive nuclear fuel cycle facilities shall be of first class, and facilities for scientific, medical, agricultural, commercial or industrial purposes shall have the appropriate category, as appropriate. set out in paragraph 3 of Annex I, except for industrial irradiation, which shall be of the first category.

Article 35. Exemption as a radioactive installation.

For the purposes of this Regulation, the following shall not be considered to be radioactive installations covered by the assumptions in Annex I.

Article 36. Required authorizations.

1. The radioactive installations of the nuclear fuel cycle shall require the following authorisations: prior authorisation, construction authorisation, operating authorisation, decommissioning authorisation and closing declaration and, in their Case, modification authorization, and entitlement change authority.

2. Radioactive installations for scientific, medical, agricultural, commercial or industrial purposes shall require an operating authorisation, a closing declaration and, where appropriate, an authorisation for modification and change of ownership.

CHAPTER II

Radioactive nuclear fuel cycle installations

Article 37. Requests.

For the application, processing and granting of authorizations, prior to, construction, operation, modification, change of ownership, dismantling and closing declaration of the first class radioactive installations of the nuclear fuel cycle, the provisions of Title II of this Regulation governing the authorisations of nuclear installations shall be within the meaning of Title II of this Regulation, with the adaptation of the documents corresponding to the special characteristics of these facilities.

CHAPTER III

Radioactive installations for scientific, medical, agricultural, commercial or industrial purposes

Article 38. Requests.

1. Radioactive installations for scientific, medical, agricultural, commercial or industrial purposes shall apply for an operating authorisation. The application shall be accompanied by 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 risk 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) Operating Regulation. 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.

e) The expected staff relationship, the projected organisation and the definition of the responsibilities for each job, both under normal operating conditions and in case of emergency, will be included.

f) 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.

g) Forecasts for closure and planned economic coverage to ensure the same in security conditions.

2. For industrial irradiation installations with radioactive sources, the description of the site shall include information on the location and surrounding areas. In addition, the organisation planned by the applicant to ensure quality during construction and operation, including the quality assurance manual, shall be attached to these facilities.

Article 39. Granting authorization.

1. It is for the Director-General of Energy to grant the authorisations referred to in this Chapter, with the exception of those relating to the first category installations, which shall be granted by the Minister for Industry and Energy.

Authorised the radioactive installation, the holder, in accordance with the rules in force and in accordance with the limits and conditions of the authorization, may proceed to its construction and assembly.

2. Where the facility is in a position to commence operations, the holder shall communicate the fact to the Nuclear Safety Board in order to enable it to carry out an inspection visit. Once the Council has estimated that the facility may operate under security conditions, it shall inform the Ministry of Industry and Energy, in order to give it a notification for implementation.

If the inspection of the Nuclear Safety Council would lead to the installation not meeting sufficient nuclear safety or radiation protection guarantees and the anomalies would not be corrected by the holder of the authorization within the time limit specified, this body shall inform the Ministry of Industry and Energy in order to ensure that the appropriate measures are taken.

3. No radioactive installation, as regulated in this Chapter, may commence its operation before the notification is available for implementation, which shall entitle the operator to commence operations.

Article 40. Changes and modifications.

Changes in ownership and modifications in design, operating conditions, or affecting the conditioning of a radioactive installation will require authorization for the same procedure as the one granted by the operating authorization.

Article 41. Decommissioning and decommissioning.

It will be the responsibility of the holder of a radioactive installation to dismantle and close it.

The closing statement request will be accompanied by the following documentation:

a) Technical study of the decommissioning, carried out according to the characteristics of the installation, indicating the inventory of radioactive materials and residues and the equipment producing ionising radiation, as well as its target and the measures taken to dismantle and, where appropriate, decontaminate the installation.

(b) Economic report, including the cost of the closure and the estimates of funding for the closure.

Article 42. Closing statement.

Once the absence of radioactive substances or ionizing radiation producing equipment and the results of the contamination analysis at the facility has been verified by the Nuclear Safety Board, it will issue a report the Ministry of Industry and Energy to issue the relevant closing statement.

TITLE IV

Inspection of nuclear and radioactive installations

ONLY CHAPTER

Inspector Take Action

Article 43. Inspectors.

1. The optional staff of the Ministry of Industry and Energy and the Nuclear Safety Board appointed to carry out the inspection and verification of nuclear and radioactive installations shall be considered as an agent of the authority in all fields. on the exercise of his office.

In the exercise of its mission, such optional personnel may be accompanied by the accredited experts deemed necessary, and may access, without prior notice and after identification, the facilities subject to inspection.

2. The Nuclear Safety Board may, on a temporary or permanent basis, highlight in nuclear facilities an accredited staff to carry out inspection and control missions.

Article 44. Obligations of the holder.

The holder of a nuclear or radioactive installation shall be obliged to:

(a) Facilitate the access of the inspectors to the parts of the facility that 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) Make available to the inspectors the information, documentation and technical means that are accurate for the performance of their mission.

d) Allow inspectors to take sufficient samples to perform the relevant tests and checks. At the request of the holder of the authorisation, a duly sealed and marked witness sample shall be left to the authorisation holder.

(e) Facilitating the access of inspectors to the work centres of suppliers of equipment and services related to the security of the installation and the development of their activities within the scope of paragraphs (b), (c) and (d) above.

Article 45. Minutes.

1. The result of the inspections shall be recorded in the minutes, a copy of which shall be delivered to the Ministry of Industry and Energy and to the operator or person who, on his behalf, has witnessed the inspection.

In any case, the owner of the installation or dependent of the installation shall be invited to witness the inspection and sign the minutes. With your signature you can record any statements you consider relevant. The refusal to do so shall not affect the processing and conclusions to be drawn up subsequently, nor shall the manifestations which it has made without signing it be taken into consideration.

2. The inspection records which are raised enjoy the presumption of accuracy with regard to the facts which are established in the case, without prejudice to the evidence which the holder of the installation may provide in defence of his rights and interests.

The mere lifting of the act does not exempt the person from formalizing or extending it to include in the file how many elements of conviction allow to justify its claims and to clarify the facts that have been used, therefore, in addition to the minutes, how many test means are necessary or timely.

Article 46. Actions in case of risk.

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

TITLE V

From nuclear and radioactive facilities personnel

CHAPTER I

Staff licensing and accreditation

SECTION 1 NUCLEAR FUEL CYCLE NUCLEAR AND RADIOACTIVE FACILITIES

Article 47. Licenses.

1. Personnel handling devices for the control of a nuclear or radioactive installation of the nuclear fuel cycle or directing such handling shall be provided with a specific licence granted by the Security Council. Nuclear.

2. There will be two classes of licenses:

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

b) Operator license, which enables, under the immediate direction of a supervisor, for the manipulation of the control and protection devices of the installation.

3. In addition, the nuclear facilities and the radioactive nuclear fuel cycle shall have a radiation protection service, which shall be responsible for a person accredited to the effect with a diploma of Head of Service of Protection. Radiological, issued by the Nuclear Safety Board.

Article 48. Characteristics of the licenses.

Operator and supervisor licenses for these facilities will be personal and non-transferable, will have a validity period of three years and will be specific to the facility concerned, without being able to be used in another other than, unless expressly authorised by the Nuclear Safety Board.

Article 49. Requests.

1. The supervisor's licences may be applied for, depending on the type of installation and tasks assigned to them in the operation of the supervisor, by means of university graduates of average grade or equivalent qualification.

2. An operator's licence may be applied for, depending on the type of installation and tasks assigned to it, by university graduates with an average degree or equivalent qualification, or by those with training comparable and adequate in nuclear safety and radiation protection, which should be reasonably appreciated by the Nuclear Security Council.

3. The Diploma of Head of the Radiological Protection Service may be requested by university graduates of higher grade and adequate training in radiation protection.

Article 50. Processing of requests.

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 number of the applicant's passport, age and address.

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 operator of the installation in which the missions to be assigned to the applicant are recorded.

(c) Certificate of aptitude for the job to be performed by a qualified medical service authorized for this purpose. Such certificate shall include physical health and mental stability requirements.

Article 51. Licensing.

1. The Nuclear Safety Board shall extend the licences and diplomas to all persons who have passed, in the judgment of a court designated by it, the tests and practices established in the training programmes of personnel who, proposal of the operator, have been approved as part of the operating rules of the facility.

2. The court shall be composed of a chairman and four members, of whom three shall be experts in the type of facility for which the licence is sought, one of which shall be proposed by the operator, and the fourth vocal safety expert nuclear or radiation protection, which shall act as secretary.

3. The licensing and the diplomas shall include the limiting conditions which are deemed appropriate for each case.

Article 52. Refresh.

Operator and monitor licenses will be refreshed for periods equal to the first concession. To this end, the persons concerned shall apply for such renewals two months in advance of the expiry date of which they possess and prove that they have effectively carried out the specific missions of each licence during the half, when less, of the period of validity of the one that expires and continue to be qualified as suitable for the job, by a specialized medical service.

Article 53. Term of validity.

Licenses and diplomas will cease to be valid for the following reasons:

a) By expiration, if they have not been properly renewed.

b) By revocation of their concession in the following cases, when they affect nuclear safety or radiation protection:

1. Prior to the processing of the appropriate file, for loss or substantial decrease in the physical or mental capacity of the holder, accredited by a specialized medical service.

2. Prior processing of the appropriate file, by acting or serious omission, voluntary or negligent, in the performance of its functions.

3. º By closing the installation.

Article 54. Required communications.

Any alteration of the physical or mental conditions of the holder of an operator or supervisor's license that diminishes the capacity and responsibility for the work shall be formally communicated to the Nuclear Security Council. 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 himself, and in any case the operator of the facility.

SECTION 2 RADIOACTIVE INSTALLATIONS FOR SCIENTIFIC, MEDICAL, AGRICULTURAL, COMMERCIAL OR INDUSTRIAL PURPOSES

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 shall be governed by the provisions of the regulations that are specifically applicable to such facilities.

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.

Article 57. Other services.

In addition, the Nuclear Safety Board, considering the radiological risk, may require the operators of the radioactive facilities to have a radiation protection service, either own or contracted, at the head of the which must exist, at least, a person accredited to the effect by the Nuclear Safety Board.

Article 58. Exceptions.

The Nuclear Security Council may exempt from the obligation to obtain a license to persons who direct or manipulate material and equipment producing ionising radiation in those facilities which, in their opinion, do not offer significant risk.

Article 59. Requests.

1. Operator licences for installations referred to in this Section may be applied for by persons with at least compulsory secondary education or equivalent training.

2. A supervisor's licence may be applied for by persons with a university degree, at least half or equivalent.

3. The diplomas of Head of the Radiological Protection Service may be applied for by persons with a higher-grade university degree and with adequate training in radiation protection.

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) Certificate of aptitude for work at risk of exposure to ionising radiation issued by a specialised medical service authorised for this purpose.

Article 61. Concession.

1. The Nuclear Safety Board shall extend the licences, in their respective field of application, and register in the relevant register to whom:

(a) Credit for having passed the courses previously approved by the Nuclear Security Council for each type of license and field of application.

(b) Be in possession of academic qualifications whose programmes, in the opinion of the Nuclear Safety Board, contain the required knowledge for a type of licence and field of application.

2. In other cases, licences and diplomas shall be awarded by the Nuclear Safety Board on the proposal of a court appointed by the Council, who shall judge whether the applicants have training and experience in their field of application. sufficient for the performance of the job in question. That court shall consist of a chairman and four vocal experts in radiation protection and in one of the fields of application of the radioactive installations, one of which shall act as secretary.

Article 62. Refresh.

Operator and monitor licenses will be refreshed for periods equal to the first concession. To this end, the persons concerned shall apply for such renewals two months in advance of the date of expiry of which they hold, certifying that they are still qualified as fit for work in the presence of ionizing radiation for a service. Specialist physician.

Article 63. Revocation and suspension.

The Nuclear Safety Board may, after processing the appropriate file, revoke or temporarily suspend the operator's and supervisor's licenses for radioactive installations and the diplomas of the Head of the Protection Service. Radiological for the reasons set out in paragraphs (a) and (b) of Article 53 of this Regulation.

CHAPTER II

From the obligations of the operating staff

Article 64. Operation personnel.

1. In any nuclear or radioactive installation subject to the authorisation process described in the above titles, the licensed personnel to be established in the relevant authorisation shall be of service at least.

2. In the case of nuclear power plants, a permanent team shall be established, composed of at least one supervisor and one operator, from the moment the nuclear fuel load begins, irrespective of the state of the nuclear fuel. operation of the installation.

Article 65. Monitors.

The supervisor is obliged to ensure that the operation of the facility is carried out in compliance with the technical specifications of operation, the operating Regulation, the internal emergency plan and any other officially approved document.

You must also faithfully follow the operating rules contained in the operating manuals, of which a copy, updated, must be permanently in place.

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 security 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.

Article 67. Information for workers.

Any person who, without needing a licence, works 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. To this end, the knowledge and expertise required should be clearly defined by the operator of the installation. The training programmes shall be pre-approved by the Nuclear Safety Board.

Such persons shall act under the specific responsibility of the holder and under the supervision of the licensed personnel.

Article 68. Head of Radiological Protection Service.

The Head of the Radiological Protection Service is responsible for ensuring compliance with the officially approved standards in relation to radiation protection, informing the service supervisor of what is appropriate in each case. time as to its application.

In the event that those rules are not observed, you will be obliged to communicate it in writing to the owner of the installation, keeping the corresponding registration at the disposal of the inspection.

TITLE VI

From the operation journal, files, and reports

ONLY CHAPTER

Installation holder obligations

Article 69. Operation journal.

The holder of the authorization of a nuclear or radioactive installation is obliged to carry an operating journal where all the information concerning the operation of the installation is clearly and concretely reflected.

Article 70. Conditions.

1. The operation journal, numbered, must be authorized, sealed and registered by the Nuclear Security Council, to this end, the holder shall request this procedure from the Agency in good time.

The operation journal in use should be in place. The copies that have been completed shall be filed and shall remain in the custody of the holder of the authorisation. Their destruction or loss shall be communicated to the Nuclear Safety Board as soon as possible for the purposes of their destruction.

2. The daily of operation may be checked and reviewed by the optional staff referred to in Article 43, where they deem it appropriate, who, if necessary, shall record the relevant observations in the same way.

Article 71. Content.

1. Taking into account the nature of the installation, and without limitation, they must be included, with date and time: start up, power and operation level, stops, incidents of any kind, checks, maintenance operations, modifications, levels of activity, discharge of radioactive effluents to the outside and storage and disposal of solid radioactive waste.

The operation journal must include the name and signature of the supervisor or, where applicable, the service operator, noting the corresponding relays or substitutions.

2. Prior to initiating an operation which may leave out of the service a equipment, instrument or system affecting nuclear safety or radiation protection, such an operation shall be explicitly authorised by the service supervisor, who log into the journal the date and time the indicated operation starts and ends, and the name of the person responsible for the operation.

Article 72. Document file.

The holder of the authorization is obliged to file all documents and records required by this Regulation, in other applicable provisions and in the permits granted during the periods of time that, in each case, are set.

Article 73. Reports.

The holder of the authorization is obliged to present in the General Directorate of Energy and in the Nuclear Security Council the following reports:

1. Nuclear installations:

a) A monthly report, presented within the first fifteen days of the following month, describing the operation of the installation and the most remarkable activities.

(b) Reports on any event that causes an alteration in the normal operation of the facility or which may affect nuclear safety or radiation protection.

c) Annual reports, presented within the first quarter of each calendar year, on operational experience, design modifications; adequacy to the new requirements of Spanish legislation, to regulations (a) the activities of the staff training and retraining programme; the results of the environmental monitoring programme; and the results of the programme for the training and retraining of staff; the results of the programme for the training and retraining of staff; statistical results of the personal dose controls.

(d) In the case of nuclear power plants, and before each reloading or maintenance stop, a report with the forecast of activities to be carried out during the period. Also, prior to post-reload startup, a reload security report covering the next cycle of operation.

2. Radioactive installations.

(a) An annual report, presented within the first quarter of each calendar year, that should contain a summary of the operations journal and the statistical results of the personal dose controls.

(b) Reports on any anomaly that may affect the safety or radiation protection, as well as the occurrence of accidents, in which the circumstances of such accidents shall be detailed.

(c) For the first category radioactive installations of the nuclear fuel cycle, the annual report referred to in subparagraph (a) above shall be quarterly. These facilities will also present annual reports, in the first quarter of each year, concerning the results of the environmental radiological surveillance programmes and the adaptation to the new requirements of Spanish legislation or international rules applicable to them.

TITLE VII

Other regulated activities

ONLY CHAPTER

Authorization of other activities

Article 74. Equipment, apparatus and accessories.

1. They shall require authorization from the Directorate-General for Energy, 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 substances or generators of ionising radiation, even if the use of such equipment is included in the exceptions provided for in Annex I.

(b) The deliberate addition of radioactive substances in the production of consumer goods, with the prohibitions laid down in the regulation on health protection against ionizing radiation.

(c) Import, export, intra-Community movement, placing on the market and any transfer of radioactive materials and equipment, equipment and consumer goods described in paragraphs (a) and (b).

d) The technical assistance of radioactive devices and ionizing radiation generating equipment.

2. The application for authorisation 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 Commercial Registry and justification of the social object.

b) Memory of the activities to be developed.

c) Where appropriate, experience of the company in activities of the same nature.

d) Organization of personnel and operating rules of the company.

e) 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 develop its actions.

g) Where appropriate, procedures to ensure the radiation protection of exposed workers due to the tasks to be performed.

3. Manufacturing, marketing and technical assistance companies which, by reason of their activities, need to have an authorised radioactive installation, may apply for a single authorisation.

Article 75. Conditioned.

1. In those cases where it is deemed appropriate by the nature of the apparatus, equipment or accessories, manufacturers, traders and sales and technical assistance undertakings, the obligation to provide services may be placed in the respective authorization. to keep a record of the activities they carry out, with the obligation to send to the Directorate-General for Energy and to the Nuclear Safety Board a quarterly ratio of the variations produced on that record during such a period.

2. Radioactive materials and equipment for ionising radiation may not be supplied, where they require authorisation as a radioactive installation for possession or use, to entities which do not have such authorisation.

3. Where the authorised manufacturer or supplier is aware that a model, equipment or accessory on the market has a defect or non-conformity which may degrade the reliability of its function, it shall formally notify its clients and the Nuclear Security Council as soon as possible and, in any case, within thirty calendar days of the detection of the defect or non-compliance.

Article 76. Disposal and treatment of radioactive substances.

The disposal, recycling or reuse of radioactive substances or materials containing radioactive substances from any nuclear or radioactive installation shall be subject to authorisation by the Directorate-General of the Energy, prior to the report of the Nuclear Security Council.

However, the disposal, recycling or reuse of such substances or materials may be exempted from this requirement, provided that they contain or are contaminated with radionuclides in concentrations or levels of activity equal to or lower than those established by the Ministry of Industry and Energy in relation to the definition of radioactive waste referred to in the fourth additional provision of Law 54/1997 of 27 November 1997. Electrical Sector.

Article 77. Transport.

The transport of radioactive materials, as well as the approval or validation of packages for the transport of such materials or of radioactive sources in a special way, when required by the regulations specified in the field of the transport of dangerous goods, shall be subject to authorisation by the Directorate-General for Energy, subject to the mandatory and binding report of the Nuclear Safety Board.

Article 78. Carriers.

1. Carriers of nuclear substances and radioactive materials, in non-excepted packages, shall be subject to a declaration procedure for which they must be registered in a register which, for that purpose, shall be established in the Directorate-General for the Energy called 'Registration of Carriers of Nuclear Substances and Radiactive Materials'.

2. Such carriers must apply for registration in the Register, with the following documentation:

(a) Accreditations for having exceeded the recognition of the vehicles to be used for such transport and for the training of personnel and possession of the meat enabled for that purpose, with regard to persons who are to drive such vehicles. All in accordance with the current regulations on the transport of dangerous goods.

(b) Localization and characteristics of facilities and dependencies which may be used for the reception, distribution and storage of nuclear substances and radiation-producing equipment and equipment in transit ionising.

3. The Directorate-General for Energy shall communicate to the Nuclear Safety Board and to the Ministry of Public Works any variation in the said Register for its knowledge and effects.

Article 79. Statement.

Facilities where uranium or natural thorium chemical reagents or their compounds, in quantities not exempted and not more than three kilograms, are used for a declaration procedure before the Council of Nuclear Security.

This declaration shall contain the name of the holder, site of the installation, reagent used and quantity of the installation.

Article 80. Storage of irradiated fuel.

The manufacture of containers for the storage of irradiated fuel will require that its design has been approved by the General Energy Directorate, prior to the mandatory and binding report of the Nuclear Safety Board.

Article 81. 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 or radiation protection of the facilities or activities referred to in this Regulation, for which it shall submit an application to the Agency, 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 application process for any of the prior authorizations in this Regulation, provided that the limits and conditions imposed in the statement.

ADDITIONAL PROVISIONS

First. Permits and plans for the restoration of uranium mines.

The exploitation permits and the execution of the plans for the restoration of the uranium mines will require, prior to their granting by the competent authority, the mandatory and binding report of the Security Council. Nuclear in the field of radiation protection.

Second. Entities for the provision of radiation protection services.

The entities provided for in this Regulation or in others developing the Nuclear Energy Act, intended for the provision of services in the field of radiation protection, such as services or technical protection units Radiation, technical assistance undertakings or dosimetry services may be exempted from the consideration of the radioactive installation in relation to the radiolabelled sources of calibration incorporated in the measuring equipment whose possession and use require for the performance of their functions, which shall be specified in the resolution authorize them.

Third. Application of other provisions.

1. The application of the provisions set out in this Regulation is without prejudice to the fulfilment of the obligations arising out of the commitments entered into by Spain on non-proliferation as well as the provisions of the Royal Decree 158/1995 of 3 February 1995 on the physical protection of nuclear materials.

2. It will also apply the provisions of the current Health Protection Regulation against Ionising Radiation, as well as in Royal Decree 413/1997 of 21 March on the protection of external workers at risk of exposure to ionising radiation by intervention in a controlled area, in so far as this Regulation does not contradict this Regulation.

3. The forecasts contained in this Regulation shall be without prejudice to the compliance of radioactive installations with medical purposes, authorised in accordance with the provisions of this Regulation, with regard to their subsequent operation, specific rules to be applied in that sector.

4. Installations of X-ray apparatus for medical diagnosis purposes and accreditations of personnel to direct or operate such facilities shall be governed by the specific provisions of Royal Decree 1891/1991 of 30 December 1991, and additional provisions.

5. Nuclear and radioactive installations as a whole or in their parts, equipment and accessories shall also be subject to the applicable industrial and technical regulations, in so far as they are specifically concerned, in accordance with paragraph 4. Article 3 of Law 21/1992 of 16 July 1992 on Industry. For such purposes, it shall be for the competent authority where the facility is located to ensure compliance.

Fourth. Environmental impact assessment procedure.

The environmental impact assessment procedure provided for in Royal Decree 1131/1988 of 30 September 1988 approving the Regulation for the implementation of the Royal Decree of 28 June 1986 of 28 June 1986 on the assessment of the of Environmental Impact, will be entered into the substantive procedures for authorisation regulated in this Regulation.

TRANSIENT PROVISIONS

First. Installations currently with provisional operating permit.

As provided for in Article 20 (e), (i) and (j), it shall not apply to nuclear installations which have, in accordance with Decree 2869/1972 of 21 July 1972, a provisional holding permit at the date of entry into force of the

this Regulation shall apply.

Second. Previous procedures.

The procedures falling within the scope of this Regulation, which have been initiated prior to their entry into force, shall be in accordance with the procedures to be completed on the basis of this Regulation.

Third. Validity of authorization.

1. The validity of the authorisations in force for the entry into force of this Regulation shall be maintained until their expiry.

2. Within two years of the entry into force of this Regulation, the holders of radioactive installations whose category may be modified by the provisions of this Regulation shall regularise their situation with the Ministry of Industry. and Energy, in accordance with the determinations to be made pursuant to this Regulation.

Fourth. The validity of the licenses.

The current holders of operator or supervisor's licences or diplomas of Head of the Radiological Protection Service who, at the entry into force of this Regulation, lack the necessary qualifications to obtain them, as set out in Title V thereof, may continue in the exercise of their duties and, where appropriate, carry out their renewal in accordance with this Regulation, except as regards the new requirements for certification or qualification, which will not apply to them.

ANNEX I

Radioactive installations: classification and exemption

1. For the purposes of this Regulation, the following shall not be considered to be radioactive

:

a) Radioactive substances, if the activity does not exceed in total the exemption values indicated in the second column of Table A.

b) Radioactive substances, if the activity per mass unit does not exceed the exemption values indicated in the third column of Table A.

(c) The use of apparatus containing radioactive substances that exceed the activities or activity values per unit of mass specified in paragraphs (a) or (b), provided that they correspond to an approved type by the Ministry of Industry and Energy, as set out in Annex II. The approval resolution must specify the conditions for its removal.

(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, in normal operating conditions, a dose rate of more than 1 µ Sv/h at no point at 0,1 m of the accessible surface of the appliance.

(e) handling of equipment emitting ionising radiation, other than those referred to in paragraph (d), provided that they correspond to a type approved by the Ministry of Industry and Energy, in accordance with the provisions of the Annex II.

(f) Material contaminated with radioactive substances from authorised evacuations, which have been declared by the Ministry of Industry and Energy, prior to the report of the Nuclear Safety Board, as not subject to subsequent controls.

g) The Ministry of Industry and Energy, after reporting by the Nuclear Safety Board, may declare other practices exempt when, while exceeding the values in Table A, the following conditions are met:

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 will be considered in the use of Table A:

(a) Where necessary, the Nuclear Safety Board shall assign appropriate values for the activities and activities per unit of mass in the case of radionuclides not collected in Table A. The assigned values of this form will be complementary to those in table A.

(b) The nuclides with the suffix "+" or "sec" of Table A represent the nucleid parents in secular equilibrium with their corresponding nucleid children listed in Table B. In this case, the values given in Table A are refer only to the parent nuclide, but they already take into account the nuclide (s) present.

c) In other cases of mixing more than one nuclide, the exemption shall be maintained only if the sum of the ratios between the total present activity of each nuclide and the corresponding value in Table A is lower or equal to 1. This rule shall also apply to activities per unit of mass where the various affected nucleids are contained in the same matrix.

3. For the purposes of the classification of radioactive installations in categories, provided for in the additional provision of Law 15/1980 of 22 April of the establishment of the Nuclear Safety Council, it shall be deemed to be an exempt activity reference. by nuclide the contained in the second column of Table A of this Annex, instead of the activities per radiotoxicity group, so that:

a) The facilities in which an activity greater than the exemption activity and less than a thousand times are involved shall be third category.

b) They will be of the second category where the activity is equal to or greater than a thousand times the exemption.

c) In cases of isotope mixing, 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 of the third category and if it is equal to or greater than a thousand, second.

1. Table A:

Ar-37

10⁷

Sc-48

10⁶

10⁴

10

10⁷

10⁶

10⁸

10⁸

Ni-65

10⁶

Zn-69m

-76

10⁹

⁷

Zr-93 +

10⁵

10⁷

Ru-97

Rh-103m

Pd-109

Ag-108m +

⁶

Cd-115

Te-123m

⁷

10⁵

10⁶

10⁶

I-132

I-133

10⁶

10⁴

10⁵

Nd-147

Pm-147

Pm-149

Sm-153

10⁶

Eu-154

10⁷

Tb-160

Tm-170

10⁷

10⁷

Pt-197m

TI-200

10⁵

10⁶

10⁷

10⁵

Ra-226 +

10⁴

10⁴

10⁷

10

10⁴

10³

4

10⁴

10⁴

Am-243 +

10³

10⁴

10⁴

Cf-250

10⁴

10⁵

Fm-255

Core	Activity - (Bq)	Activity per mass unit - (kBq/kg)
H-3	9	106
Be-7	7	3
C-14	107	104
0-15	109	102
F-18	106	10
	Na-22	106	10
Na-24	5	10
Si-31	106	103
5	105	103
10		105
	S-35	108	105
Cl-36	106	104
5		10
105	108	106
9	109	102
K-40	106	102
	K-42	106	102
K-43	106	10
7		104
	Ca-47
106	10
Sc-46	106	10
6		102
	6
105	10
V-48	105	10
Cr-51	7	103
Mn-51	105	10
Mn-52	105	10
Mn-52m	5	10
Mn-53	109	104
	6
106	10
Mn-56	5	10
Fe-52	106	10
106
Fe-59	6	10
	Co-55	106	10
5	105
Co-57	106	102
Co-58	106	10
7	107	104
Co-60	105	10
Co-60m	106	103
Co-61	106	2
Co-62m	2 5	10
8
104
Ni-63	108	105
106	10
	6
106	102
Zn-65	106	10
Zn-69	106	104
6	102
Ga-72	105
Ge-71	108	104
	As-73	7	103
As-74	106
As-76	105	102
	As-77	6	103
Se-75	106
	Br-82	2	106	10
	9	109	102
Kr-76	109	2
	Kr-77	2 109	102
	Kr-79	5	103
Kr-81	107	104
Kr-83m		105
4	104	104	105
Kr-85m	1010
Kr-87	3	3 109	102
	9
109	109	102
Rb-86	105	2
	Sr-85	2 106	102
107	102
Sr-87m	106
	Sr-89	2	2 106	103
	Sr-90 +	4	102
Sr-91	105
Sr-92	106	10
Y-90
105	103
Y-91	106	103
Y-91m	106	102
	Y-92	5	105	102
Y-93	105	102
10	103
	Zr-95	6	10
Zr-97 +	105	10
Nb-93m	107	104
	Nb-94	6	10
Nb-95	106	10
Nb-97	106	10
Nb-98	105	10
Mo-90	106	10
Mo-93	108	103
	Mo-99	6	102
Mo-101	106
Tc-96	Tc-96	106	10
Tc-96m	107	103
Tc-97	108	10
Tc-97m	10	103
	7	107	104
Tc-99m	107	102
2 107	102
	6
106	102
Ru-105	106
Ru-106 +	105	102
8	104
Rh-105	107	2
Pd-103	2 108	103
6	103
Ag-105	106	102
106	10
106	10
Ag-111	106	103
Cd-109	106	104
6	102
Cd-115m	106
In-111	3	3 106	102
	In-113m	6	102
In-114m	106	102
In-115m	106	102
	Sn-113	7	103
Sn-125	105
Sb-122	Sb-122	10	102
	Sb-124	106	10
Sb-125	106	102
107	102
107	103
Te-127	106	103
Te-127m	107	103
	Te-129	6	106	102
Te-129m	106	103
Te-131	105	102
	Te-131m	6	10
Te-132	107	102
Te-133	105	10
Te-133m	105	10
Te-134	106	10
I-123	10	102
	6
103
I-126	106	2
	I-129	105	102
	6
10
I-131	106	2
I-132	105	10
106	10
I-134	105	10
I-135	106	10
Xe-131m	104	104
Xe-133	104
	Xe-135	10	103
	Cs-129	5	102
Cs-131	106
Cs-132	105	10
Cs-134m	105	103
Cs-134	104	10
Cs-135	107	104
	Cs-136	5	10
Cs-137 +	104	10
Cs-138		10
106	106	102
Ba-140 +	105	10
La-140	105	10
6	106	102
Ce-141	107	2
Ce-143	106	102
	Ce-144 +	5	102
Pr-142	105	102
Pr-143	106	104
6	102
Nd-149	106	102
107	104
6	103
Sm-151	108
4	4 106	102
	6
106	10
Eu-152m	106	102
106	10
	7	107	102
Gd-153	107	2
Gd-159	Gd-159	106	103
6	106	10
Dy-165	106
Dy-166	3 106	103
	105	105	103
Er-169	107	104
Er-171	106	102
6	103
Tm-171	108
Yb-175	Yb-175	107	103
	7
107	107	103
Hf-181	106
Ta-182	4	10
	7	107	103
W-185	107
W-187	4	4 106	102
	6
106	106	103
Re-188	105	2
Os-185	2 106	10
7	107	102
Os-191m	107	3
Os-193	3 106	102
Ir-190	106	106	10
Ir-192	104	10
Ir-194	105	102
	Pt-191	106	102
Pt-193m	107
Pt-197	106	103
6	102
Au-198	106	102
Au-199	2 106	102
	Hg-197	7	102
Hg-197m	106	2
Hg-203	105	102
6	106	10
TI-201	106	2
	TI-202	106	102
4	104	104
Pb-203	106	102
Pb-210 +	Pb-210 +		10
Pb-212 +	105	10
Bi-206	105	10
Bi-207	106	10
	6	106	103
Bi-212 +	105	10
Po-203	106	10
	6
106	10
Po-207	106	10
Po-210		10
	7
107	103
Rn-220 +	107
Rn-222 +	Rn-222 +	108	10
	Ra-223 +	105	102
Ra-224 +	105	10
Ra-225	105	102
4	10
Ra-227	106	2
Ra-228 +	105	10
		106	10
Th-226 +	107	103
Th-227		10
104	1
Th-229 +	103	1
Th-230		1
107	103
Th-232 sec	103	1
Th-234 +	105	103
	6
106	10
Pa-231	103	1
Pa-233	10	102
	U-230 +	5	10
U-231	107	2
	U-232 +	2	2	1
	4	104
U-234	104	10
U-235 +		10
4
104	10
U-237	106	102
U-238 +	4	10
	3	103	1
U-239	106	102
U-240	10	103
	U-240 +	6	10
Np-237 +	103	1
Np-239	10	102
	Np-240	106	106	10
Pu-234	107	102
Pu-235	2 107	102
	4
104	104	10
Pu-237	107	3
	3	3	1
104	1
Pu-240	103	1
Pu-241	105	102
	4
104	1
Pu-243	107	3
	3 4	1
	4	104	1
Am-242	106	103
Am-242m +	4	1
103	1
Cm-242	105	102
Cm-243		1
4
104	10
Cm-245	103	1
Cm-246		1
104	1
Cm-248	103	1
Bk-249	106	103
	Cf-246	6	103
Cf-248	104
Cf-249		1
104	10
Cf-251	103	1
Cf-252	4	10
	5	105	102
Cf-254	103	1
Es-253	105	102
	Es-254	4	10
Es-254m	106	2
Fm-254	10	104
6	103

2. Table B: List of nuclides in the secular balance referred to in paragraph 2.b) of this Annex.

Ce-144 +

Rn-222 +

Core	Children's Nucleids
Sr-80 +	Rb-80
Sr-90 +	Y-90
Zr-93 +	Nb-93m
Zr-97 +	Nb-97
Ru-106 +	Rh-106
Ag-108m +	Ag-108
Cs-137 +	Ba-137
Ba-140 +	La-140
Ce-134 +	La-134
Pr-144
Pb-210 +	Bi-210, Po-210
Pb-212 +	Bi-212, TI-208, Po-212
Bi-212 +	TI-208, Po-212
	Po-216
Po-218, Pb-214, Bi-214, Po-214
Ra-223 +	Rn-219, Po-215, Pb-211, Bi-211, TI-207, Rn-220, Po-216, Pb-212, Bi-212, TI-208
Ra-224 +	Po-212
Ra-226 +	Rn-222, Po-218, Pb-214, Bi-214, Pb-210, Bi-210, Po-210, Po-214
Ra-228 +	Th-226 +
	Ra-222, Rn-218, Po-214
	Th-228 +	Ra-224, Rn-220, Po-216, Pb-212, Bi-212, TI-208, Po-212
Th-229 +	Ra-225, Ac-225, Fr-221, At-217, Bi-213, Po-213, Pb-209
Th-232 sec.	Ra-228, Ac-228, Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208, Po-212
Th-234 +	Pa-234m
U-230 +	Th-226, Ra-222, Rn-218, Po-214
U-232 +	Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, TI-208, Po-212
U-235 +	Th-231
	U-238 +	Th-234, Pa-234m
U-238 sec	Th-234, Pa-234m, U-234, Th-230, Ra-226, Rn-222, Po-218, Pb-214, Bi-214, Pb-210, Bi-210, Po-210, Po-214
U-240 +	Np-240
Np-237 +	pa-233
am-242m +	am-242
am-243 +	Np-239

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, both under normal conditions of use, and in another that may be accidentally 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 shall be arranged 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 higher than μSv/h at no point at 0,1 m of the accessible surface of the apparatus.

5. The 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 set, 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 and 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 accredited documentation showing the results obtained in the tests verified with the prototype, with respect to the radiation safety conditions.

4. Planes of the apparatus.

5. The use to which it is intended and expected useful life.

6. "Documentation" that the apparatus meets 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 occur accidentally, 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 on their risks and the basic recommendations for radiation protection to be considered during use or, where appropriate, emergency, breakdown or break.

9. The maintenance program, in Spanish, which includes, if applicable, the periodic verifications that the manufacturer recommends to carry out on the systems or parameters that affect the safety of the devices, pointing out expressly those that, based on their risks, cannot be performed by the user.

(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 case where the withdrawal is provided for by the supplier of origin, an original document issued by the supplier shall be provided to ensure that withdrawal.

(d) Supporting documentation of the quality assurance standards applied by the manufacturer of the ionising radiation producing apparatus.

e) In the case of domestic manufacturing, the manufacturing authorization of the ionising radiation producing apparatus.

f) In the case of imported goods, the General Directorate of Energy 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, for the clarifications it considers required.

8. The opinion of the Nuclear Safety Council, together with the clarifications which the petitioner has provided, will be referred by the applicant to the Directorate-General for Energy.

9. Having received the opinion of the Nuclear Safety Board, the Directorate-General for Energy shall adopt the resolution as appropriate.

10. The Directorate-General for Energy, 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 and number corresponding to it, reserving the right to impose new conditions. The above resolutions shall be published in the Official Gazette of the State.

11. The Directorate-General for Energy, 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 conducive to verifying that they maintain the security conditions of the approved type. In the event that deviations are detected, the General Energy Directorate 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 in which it is stated:

1. º The serial number of the appliance and its date of manufacture.

2. º Declaration that the type has been approved by the Directorate General of Energy, pointing out the approval number and the date of the Resolution and the "Official State Gazette" in which it has been published.

3. º That the apparatus corresponds exactly to the approved type.

4. Use for which you have been authorized.

5. The treatment or destination of the apparatus and, where appropriate, the radioactive substance it contains, at the end of its useful life.

6. º Any other information set in type approval.

b) Specifications and conditions set in type approval.

c) Manual of operation in Spanish.

d) Any other documentation set in type approval.

13. The ionising radiation producing apparatus to be supplied shall be marked as set out in the relevant type approval.

14. The user of the apparatus is obliged to respect the conditions imposed by the Directorate-General for Energy in the resolution approving the type.