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

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

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The current regulation on nuclear and radioactive facilities was approved by Royal Decree 1836 / 1999 of 3 December. Since its entry into force, the implementation and lessons learned have been shown the existence of a number of areas for improvement and deficiencies that advise their review. Likewise, the laws that constitute the frame of reference, i.e. Act 25/1964 of 29 April, on nuclear energy, and the Act 15/1980 of 22 April, creation of the Consejo de Seguridad Nuclear, have been modified by law 24/2005, November 18, reforms to boost productivity, and the law 33/2007 , 7 November, Act 15/1980 of 22 April.
The liberalization of the electricity market has been shown the need to take into account their potential impact on the safety of nuclear installations related to power generation, so it has been included among the responsibilities of the proprietor the ensure continuously incorporate new techniques that allow to carry out the management under the most up-to-date security references.
Also, mechanisms of coordination with the competent administrations are established to authorize facilities and activities that by their characteristics and situation could cause an impact on nuclear or radioactive installation of first category.
The requirement of the establishment, by the holder of a procedure is foreseen so that installation personnel, as well as the of the contracted companies and the external ones who provide their services in the same complies with the duty to inform the owners any known fact that affects or may affect the safe operation of the same and the compliance with current legislation in the field of nuclear safety and radiation protection.
What the regime of authorizations are concerned, has developed the provisions of article 28 of the Act 25/1964, 29 April, on nuclear energy, which must be heard the autonomous communities with competence in the field of management of territory and environment.
In response to the growing importance that have gained in aspects related to the physical protection of nuclear materials and facilities, the demand for the inclusion of a physical protection plan is incorporated between the required documentation for the licensing of facilities.
It has streamlined the procedure for granting authorisations for radioactive facilities, regulates in greater detail the regime of granting of dismantling and decommissioning of nuclear facilities.
In connection with the Inspector function, expands the possibilities of action in other areas which have equipment or materials that require it and coverage is given to the action in exceptional situations on facilities not subject to the system of granting of the regulations on nuclear and radioactive facilities.
By regards to licensing of operator and supervisor, expands its regulation, especially in the case of licence in respect of nuclear facilities and the nuclear fuel cycle, both in operation such as when carry out dismantling, as well as the conditions of renewal and term of their validity.
As novel aspect, regulates the control of polluted areas, which is intended to give solution to the control of land or water resources that, not belonging to facilities regulated by the regulation on nuclear and radioactive facilities, have been affected by radiological contamination.
Finally, as another aspect worth highlighting of this modification, it should be refer to the regulation of the certification and recognition of new designs and models by the Consejo de Seguridad Nuclear.
The elaboration of this Royal Decree was started on a proposal of the Consejo de Seguridad Nuclear, as laid down in article 2.a) of their law of creation, Act 15/1980 of 22 April, having been given audience social and sectoral economic agents concerned, as well as consulted to the autonomous communities.
The Royal Decree which approves has its legal basis in Act 25/1964 of 29 April, on nuclear energy, in particular in its articles 28, 36, 37 and 94 as well as article 13 of the Act 15/1980 of 22 April, creation of the Consejo de Seguridad Nuclear, in the wording given in point 9 of the sole article of law 33/2007 , of 7 November, which the reform.
Finally, the content of available has been communicated to the Commission of the European Union, in accordance with article 33 of the Treaty establishing the European Atomic Energy Community (EURATOM).
In his virtue, a proposal from the Minister of industry, tourism and trade, with the prior approval of the Minister of public administration, in accordance with the Council of State and after deliberation by the Council of Ministers at its meeting of January 18, 2008, D I S P O N G O: article 1. Modification of title I of the regulation on nuclear and radioactive facilities, approved by Royal Decree 1836 / 1999 of 3 December.



Title I of the regulation on nuclear and radioactive facilities, approved by Royal Decree 1836 / 1999 of 3 December, is modified in the following terms: one. Article 2 is worded as follows: 'article 2. Competent authorities.



1. the application of the provisions of this regulation corresponds to the Ministry of industry, tourism and trade, and the Consejo de Seguridad Nuclear, without prejudice to the competences of other departments and the autonomous communities.



2. Executive functions that correspond to the Ministry of industry, tourism and commerce, in this regulation in relation to the second and third category radioactive facilities, shall be attributed to the autonomous communities when these have transferred those functions.
3 operating authorizations referred to second and third category radioactive facilities shall be valid for the entire Spanish territory. Notwithstanding the foregoing, holder that is going to carry out any of the activities for which has authorisation, in a specific part of the territory, shall notify reliably the relevant territorial administration, and can start business notification, which must attach copy certified authorization.
Means that there is no opposition to the above if the competent authority in that territory had not manifested this opposition by a reasoned ruling, within the period of three months from the date of notification."



Two. Added a new article 3 bis, with the following wording: «article 3 bis.» Duty to inform.



1. the competent authorities for the granting of an authorisation or significant modification of an installation or activity, that by their characteristics or situation could cause an impact on nuclear or radioactive installation of first category, prior to the issuance of approval or modification, will transfer to the Consejo de Seguridad Nuclear of the report of safety or sufficient information on the question so that by this public body is issued mandatory report, which shall be binding on the terms established by law 15/1980 of 22 April, creation of the Consejo de Seguridad Nuclear.



If evaluation of this information by the Consejo de Seguridad Nuclear, this organization concluded that an increase in the risk of nuclear or radioactive, installation as a result of the new facility or activity, or the modification of the installation or existing activity cannot be excluded, you can derive measures to implement, both in nuclear or radioactive installation the installation or non-nuclear activity.
2 where there is the communication provided for in the preceding paragraph, the Consejo de Seguridad Nuclear can go ex officio to the competent administration bodies and collect the necessary information for the elaboration of this report.
The concerned bodies, in collaboration with the Consejo de Seguridad Nuclear, will establish communication protocols that ensure that establishments thus determined and considered world-class nuclear and radioactive facilities, be exchanged properly data necessary to enable holders take into consideration the nature and the magnitude of the overall risk of accident fatal in serious accident prevention policies «, safety management systems, reports of security and internal emergency plans.»



3. Article 4 is drawn up as follows: «article 4. Submission of applications.



1. Requests for authorisations which grants the Ministry of industry, tourism and trade should be addressed to the same, meeting the requirements set out in article 70 of the law of the legal regime of public administrations and common administrative procedure, and shall be accompanied by the documentation prescribed in each case.



If the Ministry of industry, tourism and Commerce appreciated that the documentation submitted is incomplete or insufficient content, require the person concerned to complete, clarify, or expand, within the period of ten days.
2. the Ministry shall forward a copy of all documentation to the Consejo de Seguridad Nuclear, its mandatory report.

Also pursuant to article 28 of the Act 25/1964 of 29 April, on nuclear energy, shall be sent, where appropriate, a copy of all documentation to the autonomous communities with powers in the field of management of the territory and the environment in which is located the installation or the planning area provided for in the basic rules on radiological and nuclear emergency planning to the effects that make allegations in within a month, according to provisions of article 12.3 of this regulation.»



Four. Article 7 is worded as follows: «article 7. Granting of authorisations.



The Ministry of industry, tourism and trade, upon receipt of the report of the Consejo de Seguridad Nuclear, and previous decisions and reports that correspond, will take the appropriate decision. The maximum period in which such resolution shall be notified shall be six months, unless it is of application the suspension referred to in paragraph 2 of the preceding article, in which case the referred deadline would be extended with the period of suspension.



Authorisations granted shall contain: a) holder of the authorization.



(b) location of the installation.
(c) activities that empowers perform the authorization granted.
(d) term of validity and conditions for its renewal, as appropriate.
(e) order the installation and, where appropriate, of the same basic features.
f) when applicable, nuclear substances and other materials and equipment producing ionizing radiation whose possession or use is authorized.
(g) official documents under cover of which is granted authorization and necessary procedure for review.
(h) requirements for licensing of personnel for the operation of the installation.
(i) guarantees that the owner has to conclude regarding the 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 be appropriate for the case.»



5. Article 8 is worded as follows: «article 8. Responsibility of the owner.



1. the holder of each authorization shall be responsible for operation of the installation or activity safely and always within the provisions of official documents under cover of which the authorization is granted. It corresponds to apply and keep updated the documentation, report to the Ministry of industry, tourism and trade and the Consejo de Seguridad Nuclear of many issues can affect the conditions of the authorisation or to nuclear safety and radiation protection and, in general, comply with the regulations. It also lies with the holder responsible for installation in emergency situations that may occur.



The holder shall ensure that all persons or legal entities involved as contractors or subcontractors also meet the requirements of the preceding paragraph, in those cases which they are entitled.
2. in the field of safeguards and physical protection of nuclear materials, the holder is obliged to perform the activities of monitoring, control and custody of such materials, to allow the inspections and checks that were precise, when these are commitments made by the Spanish State or derived from own domestic, and to inform the authorities of any relevant fact , in accordance with the specific rules in this matter.
3. the owner must ensure continuously improving the conditions of nuclear safety and radiological protection of your installation. To do this, you must analyze techniques and practices, in accordance with the requirements that establish the Consejo de Seguridad Nuclear, and implement which are suitable in the opinion of the Agency.
The Consejo de Seguridad Nuclear may require at any time the analysis of the holder for the implementation of improvements in nuclear safety and radiological protection.»



6. Added a new article 8 bis, with the following wording: «article 8 bis.» Communication deficiencies.



In accordance with article 13 of the Act 15/1980 of 22 April, creation of the Consejo de Seguridad Nuclear, for the purpose of the duty of people at the service of the nuclear and radioactive facilities to knowledge holders of any fact that may affect the safe operation of the same or to radiation protection (: a) the licensee shall establish a procedure to ensure that all staff of the Organization of the installation, as well as the of the contracted companies and the external ones who provide their services in the same, informs the holder those deficiencies or dysfunctions which, according to the communicant, could affect nuclear safety or radiation protection, all without prejudice to General of citizen rights established in the relevant laws.



This procedure will be additional to the usual channels of communication, and may be used at the option of the caller. In addition, the caller must resort to this procedure if, after communicating a deficiency by the usual channels of communication, came to the conclusion that your complaint or claim not had been sufficiently dealt with.
In the procedure they must attend all communications, whether they come from communicating identified as anonymous, and such communications shall be included in a register numbered and dated copy of the communications received, and reference the information provided in response to them and the verification steps or measures taken by virtue. The radioactive facilities for purposes of scientific, medical, agricultural, commercial or industrial, as defined in title III of this regulation, may choose to record such communications and responses and verification proceedings or measures adopted in the daily of operation referred to in Title VI of this regulation.
The caller, if it has been identified, should receive answer in writing within 7 working days by the owner of the installation with information on the measures taken or planned.
Within that period unless the holder forward written response to the caller, it shall transmit to the Consejo de Seguridad Nuclear information concerned.
The procedure will ensure the existence of a procedure shortened for those cases that the communicant appreciate reasons of urgency, which will establish the obligation of the holder to reply to the caller immediately, can it transmit, if it deems it appropriate, information to the Consejo de Seguridad Nuclear at the moment in which warned the deficiency or dysfunction appreciated.
Without limiting the foregoing, in this matter will be of supplementary application the law 30/1992, of 26 November, legal regime of public administrations and common administrative procedure.
(b) the exercise of this right may not report adverse effects for the worker in his job, except in cases that proving bad faith in his performance.
Shall be deemed null and void the holder decisions made in detriment or prejudice to the labour rights of workers who have exercised the right provided for in this article.»



Second article. Amendment to title II of the regulation on nuclear and radioactive facilities, approved by Royal Decree 1836 / 1999 of 3 December.



Title II of the regulation on nuclear and radioactive facilities, approved by Royal Decree 1836 / 1999 of 3 December, is modified in the following terms: one. Article 11 is drafted as follows: "article 11. Definitions.



They are nuclear facilities: to) nuclear power plants: fixed any installation for the production of energy via a nuclear reactor.



(b) nuclear reactors: any structure containing nuclear fuel arranged so that within it can be a feedback process of nuclear fission without an additional source of neutrons.
(c) the factories that used nuclear fuel to produce nuclear substances and factories that are appropriate to the processing of nuclear substances, including treatment facilities or reprocessed nuclear fuel irradiated.
(d) storage facilities for nuclear substances, except the places in which these substances are stored incidentally during transport.
(e) the devices and installations using nuclear reactions of fusion or fission to produce energy or with a view to production or development of new energy sources.



Two. Article 12 is worded as follows: «article 12. Required authorizations.



1 nuclear installations will require, as the case may be, the following authorizations: to) authorization prior or site: is an official recognition of the proposed objective and the suitability of the chosen location, which empowers the holder for the authorization of construction of the installation and start the preliminary infrastructure construction which are authorised.
(b) construction authorization: authorizes the holder to start the construction of the facility and for the authorization of exploitation.

(c) authorization of exploitation: empowers the owner to load nuclear fuel or to introduce nuclear substances at the facility, to carry out nuclear testing programme and to operate the installation within the conditions laid down in the authorisation. It shall be first on an interim basis until the satisfactory completion of the nuclear tests.
Similarly, this authorization empowers the owner, once ceased operation for which the installation was conceived, to perform the operations that impose the Administration prior to the authorization of dismantling.
(d) authorization of modification: empowers the holder to make changes in the design of the installation or under conditions of exploitation, in cases in which alter the criteria, standards and conditions on the authorization of exploitation.
(e) authorization of execution and Assembly of modification: empowers the holder to start carrying out, execution and Assembly of those modifications which, by its powerful or because it involves works and significant assemblies, are considered necessary to authorize expressly, in the opinion of the Directorate-General of energy and mines and the Consejo de Seguridad Nuclear.
(f) authorization of dismantling: once extinguished the authorization of exploitation, empowers the holder to start the activities of decontamination, disassembly of equipment, demolition of structures and removal of materials, so that, ultimately, full or restricted release of the site. The dismantling process will end in a closing statement, it shall be released to the owner of a facility of your responsibility as a manager of the same and shall define, in the case of the restricted release of the site, the limitations of use that are applicable and responsible for maintaining and monitoring their compliance.
In addition, it must be authorized: g) the temporary storage of nuclear substances at a facility under construction that does not have authorization of exploitation.



(h) the change in ownership of nuclear plants. The new owner must provide proof of legal, technical and financial capacity to carry out the activities subject to the authorization.
The authorizations provided for in the preceding paragraphs shall be granted prior report by the Nuclear Safety Council as provided for in this regulation.



(2 nuclear facilities referred to in the letters b) and (d)) of article 11 of this regulation, except for the final storage of radioactive waste facilities, may simultaneously apply for prior authorization and construction.



3 prior to the granting of the authorisations referred to in paragraph 1 of this article, except those referring in letters e) and g) of that paragraph, will be transfer of documentation to the autonomous community, for the period of a month, for claims, pursuant to article 4(2) of this regulation.
«((4. Corresponde ael Ministro de Industria, Turismo y Comercio la concesión de las autorizaciones recogidas en el apartado 1 de este artículo, excepto las referidas en las letras d), e) and g), which correspond to the Director-General of energy and mines.»



3. Article 13 is worded as follows: «article 13. Committee on information.



1. during the construction, operation and decommissioning of nuclear power stations, will operate a Committee on information, which will be the character of the colleges provided for in article 40.3 of the law 6/1997, of 14 April, of organization and functioning of the General Administration of the State.



2. this Committee, whose members will be appointed by the Director-General of energy and mines, will be made by a representative of the Ministry of industry, tourism and trade, the owner of the installation, of the Consejo de Seguridad Nuclear, the delegations of the Government and the autonomous communities in whose territory it is located installation, the Directorate General of Civil protection and emergency and of the municipalities included in the zone 1 defined in the corresponding emergency plans foreign nuclear power plants.
The representative of the Ministry of industry, tourism and trade will chair it, and the Mayor of the municipality in whose territory the installation is located will hold the Vice-Presidency. An official of the Ministry of industry, tourism and trade, named, will act as Secretary of the Committee likewise, by the Director-General of energy and mines.
Other representatives appointed by the Director-General of energy and mines, either on its own initiative or on the proposal of the Committee may also be part of the same.
3 will be functions of this Committee report to different entities represented on the development of the activities regulated by the corresponding authorizations and jointly treat those other issues that are of interest to those entities."



Four. Article 20 is worded as follows: «article 20. Request.



The application for the authorization of exploitation shall be accompanied by the following documents, updated, where appropriate, the contents of those presented to the authorization of construction: to) safety study. It will contain the information needed to perform an analysis of the installation from the point of view of nuclear safety and radiological protection, as well as an analysis and assessment of risks arising from the operation of the facility, both normal and accident conditions. It will also contain detailed descriptions of security features, of all systems of safety and of structures, systems and components related to the safety of their bases of design and its performance in all States operating, including stop and accident conditions. It will also identify regulations, codes and standards applicable to the installation. In particular, the documents must relate to the following topics: 1 complementary data obtained during the construction on the site and its features.



2 description of the installation as has been built, and the process will take place in it. It will include the description of nuclear instrumentation and non-nuclear, systems of control and protection, buildings or structures of containment, the auxiliaries of the systems of collection and disposal of radioactive waste, and any other system or component that is significant for the safety of the installation.
3 analysis of foreseeable accidents resulting from malfunction of components and devices, operation, or errors of outsiders to the installation and its consequences.
4th analytical x-ray study of the installation.
5 operational environmental radiation monitoring program, in order to assess the impact derived from the operation of the same.



(b) Regulation of operation. This document will contain the following information: 1 jobs related to nuclear liability, since the Director or head of operation supervisors, operators, responsible for monitoring and performers of the nuclear tests.



2. Organization. Specify the Organization and responsibilities of the personnel assigned to the installation both in normal and emergency conditions. It will also describe deployed security management. Basic training and training programmes will be defined for staff with and without a license and technical competence for each specific mission, as well as programs of retraining that are considered appropriate will be established.
3rd operational standards in normal and accident conditions. These rules and procedures that develop them should refer to the entire system and the various systems that make it up.



(c) technical operating specifications. They will contain the limit values of the variables that affect the security, the limits of action of the automatic protection systems, minimum conditions of operation, program reviews, calibration and periodic inspections of systems and components, and operational control.



(d) internal emergency plan. It will detail the measures provided for by the holder and the assignment of responsibilities to deal with the conditions of the accident, in order to mitigate its consequences, protect the installation staff and report its occurrence immediately to the competent bodies, including the initial assessment of the circumstances and the consequences of the situation. In addition, it will establish the actions envisaged by the owner to assist in interventions of protection on the outside of the facility, in accordance with external emergency plans that establish competent bodies, when so determined by the Consejo de Seguridad Nuclear.
(e) programme of nuclear tests. It will describe such evidence, its object, specific techniques and the expected results. For each test the procedure must be reported to follow, data collected in its realization and the maximum and minimum values provided for the variables of interest during the execution of the tests. It will also include the applicable security criteria for these tests.
(f) quality assurance manual. It will establish the scope and content of the program of quality applicable to testing and exploitation of systems, structures and components related with security, as well as to design, manufacture, construction, testing and exploitation of the same modifications.

(g) radiation protection manual. This document shall include standards of radiation protection of the installation.
(h) the plan of management of radioactive waste and spent fuel, which incorporated where appropriate, contracts with management companies and include, among other things, a system for possible declassification of waste materials with radioactive contents.
(i) economic study final, which will analyze the fulfillment of economic and financial forecasts, and will express the total and effective amount of the installation.
(j) decommissioning and closure forecasts. Describe, among others, those concerning the final management of radioactive waste generated and the cost study and forecasts economic and financial to ensure the closure.
(k) physical protection plan. It will describe the organisational measures, equipment, systems and components, whose objective is to achieve a level of acceptable physical security. You will need a confidential treatment.»



5. Article 30 is worded as follows: «article 30. Request.



1 application for authorization of an dismantling shall be accompanied by the documentation indicated in the letters b), c), d), f), g), h) and k) article 20, adapting the contents to the dismantling of the installation situation.



In any case, must be complied with provisions of applicable environmental legislation.
In addition must be accompanied with the following documents: to) safety study, containing: 1 descriptive study of the current state of the installation, the location and its area of influence, containing radiological characterisation installation and its location before dismantling.



2nd overall project of dismantlement, that contains the scope of each phase of the project's proposed dismantling, if there were several, as well as the description of the planned State of the installation during and after the development of the same. You should specify, for the phase for which requested authorization, activities and significant works that could cause alterations in the conditions of nuclear safety and radiation protection.
3rd security analysis of the project of dismantling, containing the rules and the radiological criteria and applicable security, as well as an analysis of accidents, identifying the anticipated risks and the corresponding preventive measures.
4th environmental study of the radiological impact during the execution of the program of decommissioning and after completing the. It will also contain a plan of applicable environmental Radiological monitoring during the implementation of the programme of dismantling.



(b) control plan of desclasificables materials, which will include the description of the processes and equipment used for the verification of the compliance of the radiological criteria for declassification of waste materials generated.



(c) restoration plan of the site, which will include the proposal and justification of the methodology for the final radiological characterization of the site, in order to demonstrate compliance with the radiological criteria for total, partial release or with restrictions on the use of the site, and the media will be proposed that will establish and maintain institutional legal controls that ensure compliance with of the radiological criteria.
(d) economic study of the process of dismantling, financial investments and expected costs for dismantling operations until the close.



2. the Consejo de Seguridad Nuclear will define the scope, content or development of the documentation listed through instructions or guidelines of a technical nature or specific requirements.»



6. Article 33 is worded as follows: «article 33. Closing statement.



1. Once finished the dismantling activities, when you have been verified compliance with the forecasts of the plan of restoring the site, as well as the other technical conditions laid down in the programme of dismantling, the Ministry of industry, tourism and trade will be the closing statement, prior report of the Consejo de Seguridad Nuclear.



This Ministry, prior to the closing statement, will give transfer, for the purposes of formulating allegations within the period of one month, to the corresponding autonomous communities with powers in the field of management of the territory and the environment in which is placed the installation, in accordance with article 28 of the Act 25/1964 of 29 April , on nuclear energy.



2. in those cases where it is necessary, the Ministry of industry, tourism and trade, following a report of the Consejo de Seguridad Nuclear, may agree the establishment restrictions of use on the grounds that the nuclear facility closed, settled inventoried such land in accordance with article 81.»



Third article. Modification of title III of the regulation on nuclear and radioactive facilities, approved by Royal Decree 1836 / 1999 of 3 December.



Title III of the regulation on nuclear and radioactive facilities, approved by Royal Decree 1836 / 1999 of 3 December, is modified in the following terms: one. Article 34 is worded as follows: «article 34. Definitions.



1 radioactive facilities means: to) the installations of any kind containing a source of ionizing radiation.



(b) the apparatus producing ionizing radiation operating at a potential difference of more than 5 kV.
(c) the premises, laboratories, factories and facilities where occur, use, possess, try, handled or stored radioactive materials, except for the incidental storage during transportation.



2. the radioactive facilities are classified into three categories.
(a) first category radioactive facilities are: 1 the factories of production of uranium, thorium and its compounds.



2. the factories of production of natural uranium fuel elements.
3rd installations that use radioactive sources for the purpose of industrial irradiation.
4th complex facilities which are handled very high inventories of radioactive substances or produce beams of radiation of very high energy yield so that the potential radiological impact of the facility can be significant.



For the purposes of this regulation, are called radiation facilities of the cycle of nuclear fuel facilities defined in paragraphs 1 and 2 b) are 2nd category radioactive facilities, provided that appropriate classification as of first category: 1 facilities where are handled or stored radioactive nuclides which may be used for scientific, medical, agricultural, commercial or industrial purposes whose total business is equal to or more than thousand times the values of exemption set out in the instruction IS-05 of the Consejo de Seguridad Nuclear.



2. installations using generators equipment of x-ray that can operate with a voltage exceeding 200 kV peak.
3rd the accelerators of particles and the facilities where stored sources of neutrons.



(c) third category radioactive facilities are: 1 facilities where are handled or stored radioactive nuclides whose total activity is greater than the exemption values set out in the instruction IS-05 of the Consejo de Seguridad Nuclear and less than thousand times the same.



2. plants using x-ray generating apparatus whose peak voltage is less than 200 kV.»



Two. Article 38 is worded as follows: «article 38. Applications.



1 radioactive facilities for scientific, medical, agricultural, commercial or industrial purposes will be an operating license. The application shall contain, at least, the following documentation: a) specification of the installation. Describe the location and construction details of floors, walls, ventilation and other similar elements.



Be justified if the choice of radionuclides and radioactive sources that shall be used in the installation and management systems of solid, liquid and gaseous radioactive waste laid down for normal operation and in case of accident, including contracts with managing companies, re-export and other modalities, as appropriate in each case.
(b) safety study. It will consist in an analysis and assessment of risks which may arise from the operation in normal system installation or because of an accident. Sufficient data shall be included to carry with them a risk analysis of the installation, regardless of the one presented by the applicant.
(c) verification of the installation. Within the specifically applicable to each case, will include a description of tests that must be the installation and, where necessary, planned maintenance schedule.
(d) Regulation of operation. Working methods and handling rules that ensure the safe operation of the installation will be presented. The applicable radiation protection measures will be also described.
It will include the expected relationship between staff, the projected organization and definition of the responsibilities that correspond to each job, both in normal operation and in case of emergency.

(e) internal emergency plan. It will detail the measures provided for by the holder and the assignment of responsibilities to deal with the conditions of the accident in order to mitigate its consequences, protect the installation staff and report its occurrence immediately to the competent bodies, including the initial assessment of the circumstances and the consequences of the situation. In addition, it will establish the actions envisaged by the owner to assist in interventions of protection on the outside of the facility, in accordance with external emergency plans that establish competent bodies, when so determined by the Consejo de Seguridad Nuclear.
(f) provisions for decommissioning and planned economic coverage to ensure it safe.
(g) budget economic investment to be carried out, it shall consist of the total and effective value of the radioactive installation or modification for which authorization is sought, whereas including all those components which by their nature are subject to the operation of the same.



2 in first class facilities will be attached in addition: to) information about the site and surrounding land within the site description.



(b) as part of the regulation of operation: 1 Manual of quality assurance and organization provided by the applicant to ensure the quality during construction and operation.



2. radiation protection Manual with the rules and procedures of radiation protection of the installation.
3rd specifications techniques of operation containing the values limits the variables that affect security, the limits of action of the automatic protection systems and the minimum operating conditions.



(c) plan of physical protection, which will describe the organisational measures, components, equipment and systems, which aims to achieve a level of acceptable physical security. You will need a confidential treatment.»



3. Article 39 is worded as follows: «article 39. Granting and effects of the authorization.



1 corresponds to the Minister of industry, tourism and trade the granting of authorizations of operation, changes in ownership and the closing statements of the first category radioactive facilities regulated by this chapter. Such authorisations will transfer of documentation to the autonomous region, to formulate claims, in accordance with the provisions of paragraph 2 of article 4 within the period of one month.



The granting of the rest of authorisations for radioactive facilities regulated by this chapter corresponds to the Director-General of energy and mines.
2. the operating license of the radioactive installation empowers the owner to proceed with the Assembly and preparation of the operations to carry out, in accordance with existing regulations and the conditions of the authorisation.
3 when the installation is ready to start operations, the holder shall communicate the fact to the Consejo de Seguridad Nuclear so this may make a visit of inspection. Once the Nuclear Safety Council has estimated that the system can work in conditions of safety, will issue a notification for the start-up, which will be sent to the holder, giving account of it to the Ministry of industry, tourism and trade.
If the Consejo de Seguridad Nuclear inspection is filed that the installation does not meet sufficient guarantees nuclear safety and radiological protection and anomalies were not corrected by the holder of the authorization within the period which is designated, this body shall inform of the fact to the Ministry of industry, tourism and trade to the coming action.
4. No radioactive install regulated in this chapter will begin operation before the notification to start up, which will entitle the holder to the start of operations.»



Four. Article 40 is worded as follows: «article 40. Changes and modifications.



1 will require authorization from the Ministry of industry, tourism and trade, following the same procedure expressed in articles 38 and 39, changes and modifications that affect the following aspects: to) ownership of the installation.



(b) location of the installation.
(c) activities that empowers the authorization granted.
(d) the installation category.
(e) incorporation of new equipment accelerators of particles which generate ionizing radiation or modification of existing ones.
(f) incorporation of additional radioactive material, not pre-authorized, higher than 3.7 GigaBequerelios total activity; for lower activities shall apply the provisions of paragraph 2 of this article.
(g) changes in equipment and structural changes that require a substantial modification of the conditions of the authorization that may affect in a significant way to nuclear safety and radiation protection.



The Nuclear Safety Council will establish criteria to determine when the modification required a visit of inspection and issuance of notification for the implementation underway.



2. changes and modifications that affect other aspects of the design or the authorized operating conditions of the installation will require only the express acceptance of the Consejo de Seguridad Nuclear prior to implantation, informing the Agency to the Ministry of industry, tourism and trade.
3. the other changes and modifications will be free implementation by the headlines, which shall inform the Ministry of industry, tourism and trade and the Consejo de Seguridad Nuclear on them, the reports provided for in paragraph 2 of article 73.
4 in addition to the above, in all cases the holder shall forward to the Ministry of industry, tourism and trade and the Consejo de Seguridad Nuclear review the documents mentioned in article 38 that are affected by the modification.»



Fourth article. Amendment of title IV of the regulation on nuclear and radioactive facilities, approved by Royal Decree 1836 / 1999 of 3 December.



Title IV of the regulation on nuclear and radioactive facilities, approved by Royal Decree 1836 / 1999 of 3 December, is modified in the following terms: one. Article 44 is worded as follows: «article 44. Obligations of the holder.



1 the holder of a nuclear or radioactive installation will be obliged a: to) facilitate the access of inspectors to the parts of the system necessary for the performance of its work.



(b) facilitate the placement of the equipment and Instrumentation required to carry out necessary checks and tests.
(c) make available to inspectors the information, documentation and technical resources that are necessary for the fulfilment of its mission.
(d) allow the inspectors sufficient samples to perform analyses and relevant checks. At the request of the holder of the authorization witness duly sealed and marked must be in possession of the a sample.
(((e) facilitate the access of inspectors to workplaces of the suppliers of equipment and services related to the safety of the installation and its activities with the scope of the letters b), c)) and (d) above.



"(((2. Las obligaciones descritas en las letras a), b), c) and d) of paragraph 1 will be extended to the person in charge of any establishment or place where the generating equipment of ionizing radiation or radioactive materials can be found."



Two. Article 46 is worded as follows: «article 46. Actions in case of risk.



1. in cases of manifest danger, the Ministry of industry, tourism and trade, as well as the Nuclear Safety Council or its accredited inspectors, may require, in the field of their respective competencies, the immediate cessation of the works, operation or operations, informing thereof the Ministry of industry, tourism and trade, taking account of the causes which gave rise to such action.



2. in exceptional situations or emergency arise and which can affect nuclear safety and radiological protection, whenever in the judgment of the Consejo de Seguridad Nuclear have their origin in facilities, equipment, businesses or activities not subject to the regime of authorizations of the nuclear legislation and may affect nuclear safety and radiological protection shall apply the provisions of this chapter.



Fifth article. Amendment of title V of the regulation on nuclear and radioactive facilities, approved by Royal Decree 1836 / 1999 of 3 December.



Title V of the regulation on nuclear and radioactive facilities, approved by Royal Decree 1836 / 1999 of 3 December, is modified in the following terms: one. Article 47 is worded as follows: «article 47. Licenses.



1 that direct the operation and staff who operate devices for control and protection of a nuclear or radioactive facility of the nuclear fuel cycle must be fitted with a supervisor and operator license respectively, granted by the Consejo de Seguridad Nuclear.



In nuclear power plants operation means any maneuver that affects the reactivity, the reactor power level or the integrity of barriers against the release of radioactive material as recorded in operating procedures.

Alterations of the core, including the loading and unloading of fuel and their transfer only require supervision by a person licensed, which will not be assigned at the same time other tasks other than the supervision of such activities. Licenses exclusively limited to this purpose can be to do so.
2 is it excepted from the obligation to have licenses to those people that, in the presence and under the supervision of an operator or supervisor with license, carry out practical training, as part of a program of training of operators and supervisors.
3. in the case of installations in dismantling, Nuclear Security Council will define the activities of operation and monitoring systems, as well as handling of radioactive materials which must be performed or directed by licensed personnel. Throughout the development of each phase of the dismantling may be, depending on the remaining risks, the need for personnel licensed, as well as the type and number of necessary licenses.
4. in the case of other nuclear facilities, Nuclear Security Council will define the activities that should be performed by licensed personnel.
5. Additionally, nuclear installations and the radioactive nuclear fuel cycle will have a service of radiation protection, which will be responsible for a person accredited for this purpose with a diploma of head of radiological protection issued by the Consejo de Seguridad Nuclear. This requirement shall apply both in the phase of operation of these facilities during the development of the active phases of dismantling. The need for a radiological protection service in the inactive phases of decommissioning shall be determined, case by case, by the CSN, in view of the radiological implications of the work carried out in these phases.»



Two. Article 48 is drafted as follows: «article 48. Features of the licenses.



Licences of operator and supervisor for these installations will be personal and non-transferable, have a maximum validity period of six years and will be specific to the facility in question, unless they can be used in another, except for express clearance of the Consejo de Seguridad Nuclear.'



3. Article 50 is worded as follows: «article 50. Processing of requests.



The application for the licence operator or supervisor and head of radiological protection diploma should be addressed to the Consejo de Seguridad Nuclear and it shall contain the name, surname, nationality, national document of identity or, in the case of foreigners, number of identity, or, failing that, his passport number or travel document age and address of the applicant.



To request the following documents shall be accompanied: to) information on academic and professional training of the applicant and his experience.



(b) Declaration of the owner of the installation in which can be stated missions that will be allocated to the applicant and its favorable assessment on required suitability for the performance of the same.
(c) medical fitness certificate, issued by a service of prevention of labour risks, after having been analyzed the requirements of physical health and mental stability for own's work with license and those that involve risk of exposure associated with workplace activities.»



Four. Article 52 is worded as follows: «article 52. Renewal.



The operator and supervisor licenses be renewed for successive maximum periods of six years. For this purpose, stakeholders will request such renewals with at least two months before the date of expiry of which possess, attaching a statement of the owner of the installation stating that: to) have remained effectively and with the necessary competence to exercise the specific missions of each license, fulfilling the conditions of active tenure as are specified in the technical regulations approved by the Consejo de Seguridad Nuclear.



(b) they have followed with exploitation continued training program.
«c) continue being qualified suitable for the job with license, for a service of prevention of labour risks, in the terms established in the letter c) Article 50.»



5. Article 53 is hereby repealed.



6. Article 54 is hereby repealed.
7. Article 55 is worded as follows: «article 55. Licenses.



1. the personnel who handle material or radioactive equipment, and which direct such activities in a facility regulated in this section, must be equipped with a specific license granted by the Consejo de Seguridad Nuclear.



2 there will be two kinds of licenses: a) operator's license, which enables the manipulation of materials or equipment producing ionizing radiation in accordance with procedures and instructions preset to.



(b) license supervisor, that enables to manage and plan the operation of a radioactive installation and the activities of the operators.



3. the accreditation of staff to manage and operate facilities for the purpose of medical diagnosis x-ray are governed by provisions of the regulations which is specifically applicable to such facilities.



4. licences granted by the Consejo de Seguridad Nuclear have validity for the purposes of training in safety and radiological protection, without prejudice to the qualifications and requirements that are required, in each case, in the professional order and on the basis of applied techniques to recognize."



8. Article 56 is worded as follows: «article 56. Features of the licenses.



1. the operator and supervisor for this type of facility licenses have a minimum period of validity of five years, will be personal and non-transferable and specific field of application. The Nuclear Safety Council be established fields of application that should fit the activities of personnel with license, based on the different types of installation according to their purpose.



2. the Consejo de Seguridad Nuclear will maintain a register in which operator and supervisor licenses granted by field of application and installation to which it is applied shall be entered. For this purpose, the licensees must notify the Consejo de Seguridad Nuclear data from facilities that provide or which have a contract to provide services.'



9. Article 60 is worded as follows: 'article 60. Processing.



1. the request of licenses and diplomas should be addressed to the Consejo de Seguridad Nuclear, and it shall set forth the name, surname, nationality, national document of identity or the passport number, age and address of the applicant.



2 a request will accompany the following documentation: a) information on academic and vocational training of the applicant and on his experience, in accordance with modalities of accreditation provided for in the following article b) certified medical fitness, issued by a service of prevention of labour risks, after having analyzed the requirements of physical health and stability psychic to perform activities and work with license and those that involve risk of exposure associated with to the job."



10. Added a new 'Section 3rd term of validity and suspension of licences and diplomas' in title V, chapter I, comprising articles 63, 63 bis and ter 63, in the following terms: «section 3 term of validity and suspension of licences and diplomas article 63.» End of the term.



Licences and diplomas for all kinds of nuclear and radioactive facilities will no longer be in force for the following reasons: to) for revocation, if they have not been properly renovated.



(b) by reversal, after processing of the appropriate record, in the following cases, when they affect nuclear safety and radiological protection: 1 for loss or substantial reduction of physical health or psychological stability of the holder, accredited with the corresponding medical certificates.



2nd by not voluntarily submit to the tests indicated by the titular holder or of the Consejo de Seguridad Nuclear to verify their conditions of fitness.
3rd by action or serious, voluntary or negligent, omission in the performance of their duties.
4th by termination of the contractual relationship, in the case of licences to nuclear and radioactive nuclear fuel cycle facilities.



(c) with the closure of the facility, in the case of licences to nuclear and radioactive nuclear fuel cycle facilities.



(d) by resignation of the licensee.
(e) by disqualification for the corresponding disciplinary record.
(f) in any other circumstances in which, for safety reasons is deemed necessary, prior treatment of the corresponding dossier.



Article 63 bis. Suspension of licences and diploma.



El Consejo de Seguridad Nuclear may suspend licences in the following cases: a) for safety reasons.



(b) for loss of the technical qualifications for the performance of their duties.
(c) as precautionary measures after it has started a record penalties, if judged appropriate.
(d) by idle when not to perform work for which is empowered in the conditions and terms established the Consejo de Seguridad Nuclear.



Article 63 ter. Necessary communications.




Any alteration of the physical or psychological conditions of the holder of a licence of operator or supervisor or diploma that diminishes the ability and responsibility to work, must be communicated formally to the Consejo de Seguridad Nuclear in a period not exceeding fifteen days from the date in which it was detected. «This communication should be done, if possible, the person concerned.»



Eleven. Article 65 is worded as follows: «article 65. Supervisors and operators.



1. the supervisor is obliged to direct the operation serving the technical specifications of operation, operating rules, the internal emergency plan and any other document under cover of which has been granted the corresponding authorisation of the installation in relation to the operation of the same. In addition, you must faithfully follow operating procedures, of which a copy, updated, should be permanently preset instead. When there is a procedure to perform a certain operation of unforeseen nature and admitting no delay, the supervisor shall write it before his execution and will include it in the journal of operation. In case of emergency, it shall take measures deemed appropriate, leaving evidence of them in the newspaper.



2. the operator is obliged to operate devices of control and protection, under the direction of the supervisor, faithfully following operating procedures, the technical performance specifications, operating rules and any other official document installation, with regard to the operation of the same."



12. Article 66 is worded as follows: «article 66. Duties and powers.



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



2. the operator of a nuclear or radioactive facility is authorized to proceed in the same way if, in addition to the above circumstances, it is impossible to inform the supervisor promptly as required.
3 supervisors and operators are required to inform the owner of the installation defaults that, in its view, exist in official authorisation documents or procedures of operation or any other that may affect nuclear safety or radiation protection, through the procedure referred to in article 8 bis.
4 licensed personnel must know and authorize the work carried out at the facility, provided that they directly affect the operation of the same."



13. Article 67 is worded as follows: «article 67. Information workers.



Any person who works at a nuclear or radioactive facility must know and meet standards for protection against ionizing radiation and its action in case of emergency. Additionally, the staff that perform tasks related to nuclear safety and radiological protection, must have the necessary training to perform their functions adequately. To this end, the owner of the installation must clearly define the skills and expertise necessary and establish training programs that are needed, that they will be available for the inspection of the Consejo de Seguridad Nuclear.»



Article six. Amendment to Title VII of the regulation on nuclear and radioactive facilities, approved by Royal Decree 1836 / 1999 of 3 December.



Title VII of the regulation on nuclear and radioactive facilities, approved by Royal Decree 1836 / 1999 of 3 December, is modified in the following terms: one. The current "single chapter. Authorization of activities' happens to be his 'chapter I', with the same name current and integrated by articles 74 to 80.



Two. Article 74 is worded as follows: «article 74. Radioactive materials, equipment, appliances and accessories.



1 will require authorization from the Directorate-General for energy and mines, following a report of the Consejo de Seguridad Nuclear, without prejudice to the competences of other departments: to) the manufacture of appliances, equipment and accessories that incorporated radioactive materials or are generators of ionizing radiation, although the use of them is covered by the exemptions provided for in annex I.



((b) the introduction in the Spanish market of consumer products that incorporate radioactive materials, although the use of them is covered by the exemptions provided for in Annex i. c) radioactive materials and marketing of apparatus, equipment, accessories or other items that incorporate radioactive materials or are generators of ionizing radiation, although the use of them is covered by the exemptions provided for in annex I with the exception of consumer products considered in (b)).
(d) the transfer of radioactive without holder to any authorized entity. In this case, it is not necessary to accompany the documentation referred to in paragraph 2.
(e) the technical assistance of the radioactive devices and ionizing radiation equipment.



2 application for authorization shall be accompanied by the following documentation: a) identification of the company or entity: company name, tax identification number, address certification of registration in the commercial register and justification of the social object.



(b) annual report of the activities that are going to develop.
(c) where appropriate, experience of the business activities of the same nature.
(d) Organization of staff and rules of operation of the company.
(e) relation between the technical staff of template, expression of their qualification, qualification and professional experience.
(f) relationship of the facilities, equipment, and material resources available to the company or entity to develop their performances.
(g) where necessary, procedures for the radiological protection of workers exposed for tasks that are going to be developed.
3. the import, export and intra-Community movement of radioactive materials will be fulfilling the international commitments made by Spain on this matter.
4. the companies in manufacturing, marketing and technical assistance which, because of their activities, need to have a radioactive installation authorized, may apply for a single authorisation.»



3. Article 78 is worded as follows: «article 78. Registration of carriers.



1. carriers of radioactive materials in packages not excepted, should declare this activity enrolling in a record that, for that purpose, shall be established in the Directorate-General for energy and mines called "record carriers of radioactive materials". The development of the activity of transport of radioactive material must conform, the transportation of dangerous goods regulations as well as the regulation on health protection against ionizing radiation and other applicable nuclear legislation.



2 are exempted of registration when registering companies engaged in expeditions under hiring another company registered carrier, acting is as responsible for that the first conform to the legislation applicable to transport of radioactive material.
3 such carriers must apply for registration to the mentioned registry, attaching the following documents: to) registered office of the company.



(b) transport types, frequencies and usual routes.
(c) location and characteristics of facilities and units that can be used for the reception, distribution and storage in transit of radioactive materials.



4. carriers must notify the registry variations on reported data.



5. the Directorate-General for energy and mines shall communicate to the Nuclear Safety Council and the Ministry of public works any variation that occurs in this register, for their knowledge and effects."



Four. Article 80 is worded as follows: «article 80. Storage of spent fuel.



Containers used for storage of spent fuel will require that its design has been approved by the Directorate-General for energy and mines, prescriptive and binding report of the Consejo de Seguridad Nuclear."



5. Added a 'chapter II. Contaminated areas», composed of a single article, 81, with the wording that follows: "chapter II article 81 contaminated Areas. Control of contaminated areas.



1. public administrations or the owners of the facilities or activities, whether or not they are subject to the regime of authorizations provided for in this regulation, shall inform the Consejo de Seguridad Nuclear all event that potentially derived radiological contamination of land or water resources.



2 plans for mitigating effects or decontamination of the land or affected hydrological resources that may be developed, which will correspond to the owners thereof, shall be referred to the favourable opinion of the Consejo de Seguridad Nuclear. After corrective actions, the Consejo de Seguridad Nuclear shall inspect and re-evaluate the radiological conditions of the area, and may give an opinion to the appropriate effects, which will determine if come the corresponding limitations of use of land or resources affected, giving the same transfer to the corresponding autonomous community.

3. the Nuclear Safety Council will draw up an inventory of land or water resources that have knowledge that have been affected by radiological contamination, informing thereof the competent authorities for the appropriate purposes.»



6. Added a 'chapter III. Assessment, certification and validation of designs», which is worded as follows: «Chapter III assessment, certification and validation of designs article 82. Appreciation of new designs or models.



1. any person or entity may request the issuance of a statement of appreciation favorable over new designs, methodologies, models of simulation or verification protocols related to nuclear safety and radiation protection of the facilities or activities referred to in this regulation, of the Consejo de Seguridad Nuclear for presenting an application before the Agency, accompanied by the documents required to make this Declaration.



2. the Declaration of the Consejo de Seguridad Nuclear may be included as a reference in any further process of application for any of the authorisations provided for in this regulation, subject to the limits and conditions imposed in the Declaration.



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



1 a the purpose of this regulation means: to) attestation of conformity of a design: acceptance by the Consejo de Seguridad Nuclear of its use in Spain.



(b) recognition of a design: acceptance by the Consejo de Seguridad Nuclear of a certification of conformity or equivalent documentation issued by the competent authority in the field of nuclear safety and radiation protection in another country, whose technical rules compatible with the applied in Spain.



2 may certify or validate designs, generic or not, among others, of: a) nuclear fuel.



(b) safety analysis methodologies.
(c) simulation models.
(d) verification protocols.
(e) storage of spent fuel containers.



3. any natural or legal person may ask the Council for Nuclear safety certification or recognition of a design. The application for certification or validation will accompany the following documents: to) the description of the design that you want to certify or validate, justifying the intended use.



(b) studies that permit to guarantee the required safety conditions are met.
(c) in the case of validation, documents certifying the certification of conformity or equivalent documentation.
(d) any other which the applicant considers necessary in support of its application."



Seventh article. Modification of the final part and the annexes to the regulation on nuclear and radioactive facilities, approved by Royal Decree 1836 / 1999 of 3 December.



The final part and the annexes to the regulation on nuclear and radioactive facilities, approved by Royal Decree 1836 / 1999 of 3 December, are modified in the following terms: one. Amending the fourth additional provision, with the following wording.



«Fourth additional provision. Environmental impact assessment procedure.



The procedure of environmental impact assessment provided for in Royal Decree 1/2008 of 11 January, which approves the revised text of the law on evaluation of environmental impact of projects, incardinará substantive authorization procedures covered in this regulation.'



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



«Fifth transitional provision. Period of adaptation to the new requirements.



Holders of activities and facilities subject to the provisions of the regulation on nuclear and radioactive, facilities which the entry into force of this Royal Decree are in possession of a licence or authorization in force, as well as carriers of radioactive materials that are registered in the hitherto called register of carriers of nuclear substances and radioactive materials they will have six months to adapt to the new requirements set out in the same».



3. Annex I is worded as follows: ' Annex I radioactive facilities: classification and exemption 1.» For the purposes of this regulation will not have the consideration of radiation facilities those involving: a) radioactive substances, if the activity does not exceed in total the exemption values indicated in the second column of the table of the IS/05 statement to the Consejo de Seguridad Nuclear.



(b) radioactive substances, if the activity per unit mass does not exceed the exemption values indicated in the third column of table A of the instruction IS/05 of the Council of Nuclear Security.
((c) the use of equipment containing radioactive substances exceeding the values of activity per unit mass specified in letters a) or b or activities), provided correspond to a type approved by the Ministry of industry, tourism and trade, in accordance with annex II. The resolution of approval shall specify the conditions for their elimination.
(d) the use of any cathode ray tube intended to provide visual images, or other electrical appliance that works with a potential difference not exceeding 30 kV and electron microscopes, provided that do not present in normal operating conditions, a dose rate exceeding 1 µSv/h at any point located 0,1 m from the accessible surface of the apparatus.
e) the handling of devices emitting ionizing radiation, other than those referred to in point (d)), provided correspond to a type approved by the Ministry of industry, tourism and trade, in accordance with annex II.
(f) material contaminated with radioactive substances from authorized evacuations, that have been declared by the Ministry of industry, tourism and trade, following a report of the Consejo de Seguridad Nuclear, as not subject to further controls.
(g) the Ministry of industry, tourism and trade, following a report of the Consejo de Seguridad Nuclear, may exempt other practices when, even exceeding the values of table A of the IS/05 statement to the Consejo de Seguridad Nuclear, the following conditions are met: 1 the expected effective dose for any member of the public due to the exempted practice is of the order of 10 µSv per year or less , and 2 the collective effective dose committed by each year of the implementation of the practice is not more than 1 Sv person or an assessment of the optimization of radiation protection shows that exemption is the optimum condition.



2 the use of table A of the instruction IS/05 of the Council of Nuclear safety shall take into consideration the following rules: to) when necessary, the Nuclear Safety Council will assign values suitable for the activities and activities per unit of mass in the case of radionuclides that do not exist in the table A. The values assigned in this way will be complementary with respect to table A.



(b) the nuclides with the suffix ' + ' or 'sec' in table indicated A parents represent the nuclides in secular equilibrium with its nuclides for children listed in table B of the IS/05 statement to the Consejo de Seguridad Nuclear. In this case, the values given in the table A refer only to the parent nuclide, but already take into account the / the nuclide (s) son (s) present (s).
(c) in other cases of mixture of more than one nuclide, the exemption will be maintained only if the sum of the ratios of the total activity of each nuclide and the corresponding value listed in table A of the instruction IS/05 of the Council of Nuclear security is less than or equal to 1. This rule applies also to the activities per unit mass where the various nuclides concerned are contained in the same matrix.



3 a effects of radioactive installations in categories classification, provided for in article 34, shall be considered as activity reference exempt by nuclide contained in the second column of table A of the instruction IS/05 of the Council of Nuclear security, in a way that: to) will be the facilities that involved in an activity of exemption and less than thousand times this third category.



(b) they shall be second-rate those where activity is equal to or greater than a thousand times that of exemption.
«(c) in the case of mixture of isotopes, if the sum of the ratios of the activity of each isotope and the exemption is between one and thousand, the installation will be third-category and if it is equal to or greater than 1000, second.»



Four. Annex II is worded as follows: "annex II approval of types of radioactive equipment general conditions 1.» To approve the type of a device that incorporates radioactive substances or generator of ionizing radiation, with a view to their exemption as radioactive installation, this should provide sufficient safety against leakage of ionizing radiation, both in normal conditions of use, as in other that may accidentally occur, including possible incorrect uses.



2. the apparatus shall provide advantages that, in relation to their potential risk, justify its use.
3 case of containing radioactive substances must be arranged in the form of encapsulated source so as to ensure protection against any escape or escape of the radioactive substance.

4. the device will be in normal operating conditions a dose rate exceeding 1 µSv/h at any point located 0,1 m from the accessible surface of the same.
5 the type approval must be requested by the national manufacturer or, where appropriate, by the importer.
For the approval of type of a unit of foreign manufacture, manufacturing or distribution is authorized in the country of origin or that it complies with the legal requirements established, to be shown with the appropriate supporting documentation will be required.
6. the request of the type approval will be processed in accordance with article 4 of this regulation.
It may be coverage in a single type approval to devices that are from the same manufacturer and the same scope, not being able to include in the same passage, devices incorporating radioactive substances with those that are generators of ionizing radiation.
The application shall be accompanied by the following documents: to) supporting documentation that the applicant, if it is domestically, has authorization from radioactive installation.



(b) documentation that allows a full knowledge of the type approved. This documentation shall contain, as a minimum: 1 identification of the make and model of the device.



2. 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.
3rd supporting documentation stating the results of the trials tested the prototype, regarding the conditions of radiation safety.
4th planes of the appliance.
5 use for which it is intended and expected life-span.
6 supporting documentation that the device meets the purpose for which it is intended. In the case of new practices, justify the use of the device against non-radioactive alternatives and presented an analysis of its advantages against the potential risks it presents.
7th risk analysis in situations that may accidentally occur, including incorrect uses. In the case of devices supplied with radioactive material, analysis will consider access to the population by loss of control over it.
8 operation Manual, in Spanish, which will be delivered to the users and to collect their technical specifications and instructions for use, information about their risks and the basic radiation protection recommendations to consider during its use or, in its case, of emergency, breakdown or breakage.
9th maintenance program, in Spanish, including, if necessary, periodic verifications that the manufacturer recommended on systems or parameters that can affect the safety of appliances, expressly noting those which, based on their risk, not may be the user.



(c) for devices equipped with radioactive material a proposal for management of the same will be done at the end of its useful life. If this is the case, the proposal will be supported with an analysis of the risks that such management may involve the population. In the case that expected the withdrawal by supplier origin, an original document issued by the same, ensuring that withdrawal will be provided.



(d) supporting documentation of quality assurance standards applied by the manufacturer of the appliance producing of ionizing radiation.
(e) in the case of national manufacturing, manufacturing of ionizing radiation-producing equipment authorization.
(f) in the case of being imported merchandise, the Directorate-General for energy and mines or Nuclear Security Council may require the Spanish translation of the documentation that is deemed necessary, supported by the Consulate of Spain in the country of origin.



7. the Nuclear Safety Council, upon receipt of the copy of all documentation, shall give its technical opinion on safety, which may request of the petitioner, if deemed necessary, clarifications deemed necessary.



8. the opinion of the Consejo de Seguridad Nuclear, together with explanations, where appropriate, has provided the applicant, shall be forwarded by the Agency to the Directorate-General for energy and mines.
9 received the opinion of the Consejo de Seguridad Nuclear, the Directorate-General of energy and mines will adopt the resolution that is appropriate.
10. the Directorate-General for energy and mines, in approving resolutions of types, will describe the characteristics of the type, the use to which it is supported and conditions and obligations to which it is subjected and initials and number that correspond, reserves the right to impose new conditions. Approving resolutions above will be published in the "official bulletin of the State".
11. the Directorate-General for energy and mines, on the proposal of the Consejo de Seguridad Nuclear, may require the importer or manufacturer national trials or tests on certain units supplied, leading are carried out to check that they kept the safety conditions of the approved type. In the event that deviations are detected, the Directorate-General for energy and mines may cancel the type approval.
12 the Spanish manufacturer or the importer of a product with the approved type, are obliged to supply the following documentation with each copy: to) a certificate which is made to contain: 1 the serial number of the appliance and the date of manufacture.



2. Declaration of that type has been approved by the Directorate-General for energy and mines, pointing out the number of approval and the date of the resolution and of the "official bulletin of the State" which has been published.
3rd the device corresponds exactly to the approved type.
4th use for which it is approved.
5th treatment or target device and, where appropriate, of the radioactive substance containing, at the end of its useful life.
6 any other information established in the type approval.



(b) specifications and conditions laid down in the type approval.



(c) manual operation in Spanish.
(d) any other documents established in the type approval.



13 appliances producing ionizing radiation which may be provided shall be signposted as it is established in the corresponding type approval.



14. the user of the device is obliged to respect the conditions imposed by the Department of energy and mines in the resolution which approved the type.»



Sole repeal provision. Repeal legislation.



Many provisions of equal or lower rank is contrary to the provisions of this Royal Decree are repealed.



First final provision. Skill-related title.



This Royal Decree is issued under cover of the provisions of article 149.1.16. ª and 25.ª of the Constitution which attributed to the State competition over bases and coordination of health and bases of the regime and mining, respectively.



Second final provision. Entry into force.



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



Given in Madrid on January 18, 2008.



JUAN CARLOS R.



The Minister of industry, tourism and trade JOAN CLOS I MATHEU

Related Laws

1997 Atomic Act