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Law No. 111 Of 10 October 1996 * Republished On Conducting Activities In Nuclear Safety

Original Language Title:  LEGE nr. 111 din 10 octombrie 1996 *** Republicată privind desfăşurarea în siguranţa a activităţilor nucleare

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LEGE no. 111 of 10 October 1996 (** republished) (* updated *) on the safe conduct, regulation, authorisation and control of nuclear activities ((updated on 31 December 2015 *)
ISSUER PARLIAMENT




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** **) Republicated pursuant to the provisions art. II of Law no. 63/2006 to amend and supplement Law no. 111/1996 on the safe conduct of nuclear activities, published in the Official Gazette of Romania, Part I, no. 301 of 4 April 2006, giving the texts a new numbering.
Law no. 111/1996 on the safe conduct of nuclear activities was republished in the Official Gazette of Romania, Part I, no. 78 78 of 18 February 1998 and has been amended by:
- Government Emergency Ordinance no. 204/2000 for amendment art. 8 8 of Law no. 111/1996 on the safe conduct of nuclear activities, published in the Official Gazette of Romania, Part I, no. 589 of 21 November 2000, approved with amendments and additions by Law no. 384/2001 , published in the Official Gazette of Romania, Part I, no. 400 of 20 July 2001 (corrected in the Official Gazette of Romania, Part I, no. 443 443 of 23 May 2006);
- Government Emergency Ordinance no. 90/2003 for amendment Law no. 141/1997 on the Customs Code of Romania and art. 16 of Government Emergency Ordinance no. 64/2003 for the establishment of measures regarding the establishment, organization, reorganization or functioning of structures within the working apparatus of the Government, ministries, other specialized bodies of the central public administration and some public institutions, published in the Official Gazette of Romania, Part I, no. 712 of 13 October 2003, approved with amendments by Law no. 39/2004 , published in the Official Gazette of Romania, Part I, no. 238 238 of 18 March 2004;
- Law no. 193/2003 to amend and supplement Law no. 111/1996 on the safe conduct of nuclear activities, published in the Official Gazette of Romania, Part I, no. 343 343 of 20 May 2003;
- Law no. 549/2004 for amendment art. 41 41 of Law no. 111/1996 on the safe conduct of nuclear activities, published in the Official Gazette of Romania, Part I, no. 1.164 1.164 of 8 December 2004.
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+ Chapter I General provisions + Article 1 The object of this law is the regulation, authorization and control of nuclear activities carried out for exclusively peaceful purposes, so as to meet the requirements of nuclear safety, protection of professional exposed personnel, of the patient, of the environment, of the population and of the property, with minimal risks in accordance with the regulations and in compliance with the obligations arising from the agreements and conventions to which Romania is a party. + Article 2 The provisions of this law apply to the following activities and sources a) research, design, possession, location, construction, installation, commissioning, trial operation, operation, modification, conservation, decommissioning, import and export of nuclear installations; b) design, possession, location, construction-assembly, commissioning, operation, preservation and decommissioning of mining and uranium ore mining and thorium ores and waste management facilities at the end of the year. mining and preparation of uranium and thorium ores; c) production, location and construction, supply, rental, transfer, handling, possession, processing, treatment, use, temporary or definitive storage, transport, transit, import and export of radiological installations, nuclear and radioactive materials, including nuclear fuel, radioactive waste and ionising radiation-generating devices; d) the production, supply and use of the dosimetric control apparatus and the ionizing radiation detection systems, materials and devices used for the protection against ionizing radiation, as well as the means of containerisation or transport of radioactive materials, specially designed for this purpose; e) the production, supply, rental, transfer, possession, export, import of materials, devices and equipment set out in Annex no. 1 to this Law; f) the possession, transfer, import and export of unpublished information, related to materials, devices and equipment pertinent to the proliferation of nuclear weapons and other explosive nuclear devices, set out in Annex no. 1 to this Law; g) the realization of products and services for nuclear installations; h) the realization of products and services for radiation sources, dosimetric control equipment, ionizing radiation detection systems, materials and devices used for the protection against ionizing radiation; i) orphan sources, from their detection to final storage as radioactive waste. + Article 3 The terms and expressions used in the law are defined in Annex no. 2 to the present law. + Article 4 (1) The national nuclear power authority, which exercises the regulatory, authorization and control powers provided for in this Law, is the National Commission for the Control of Nuclear Activities, a public institution of national interest, with legal personality, based in Bucharest, led by a president with the rank of secretary of state, coordinated by the Prime Minister, through the Prime Minister's Chancellery. (2) The Regulation on the organization and functioning of the National Commission for the Control of Nuclear Activities, hereinafter referred to as the Commission, is hereby approved by the Government. ----------- Alin. ((3) of art. 4 4 was repealed by letter e) a art. 14 of EMERGENCY ORDINANCE no. 1 1 of 25 January 2010 , published in MONITORUL OFFICIAL no. 62 62 of 27 January 2010. (4) The authorization fees of the activities referred to in art. 2 are made income to the state budget. ----------- Alin. ((5) of art. 4 4 was repealed by letter e) a art. 14 of EMERGENCY ORDINANCE no. 1 1 of 25 January 2010 , published in MONITORUL OFFICIAL no. 62 62 of 27 January 2010. (6) The Commission may have in subordinate technical-support institutes, established by Government decision. + Article 5 (1) The Commission shall be empowered to issue regulations for the breakdown of general nuclear safety requirements, protection against ionising radiation, quality assurance, non-proliferation of nuclear weapons, physical protection, transport of radioactive materials, radioactive waste management and nuclear fuel, intervention in the event of a nuclear accident, including procedures for the authorisation and control, achievement of the intended products and services nuclear installations as well as any other regulations necessary for the activity of authorization and control in the nuclear field. (. The Commission shall develop the strategy and policy of regulatory, security clearance and control, protection against nuclear radiation, control of non-proliferation of nuclear weapons, physical protection of nuclear materials and installations, transport of radioactive materials and nuclear safety of radioactive waste management and nuclear fuel, as part of the National Strategy for the development of the nuclear field, and shall be approved by Government Decision. (3) The Commission may also issue regulations, in consultation with ministries and other stakeholders, according to their specific responsibilities. (4) I am an exception to the provisions of para. (1) the regulations and powers of authorization and control for which this law contains express provisions for the empowerment of other ministries and specialized bodies of the central public administration. (5) The Commission, by the regulations issued and by the measures ordered in the framework of the authorisation and control procedures, must ensure the appropriate framework in which the natural person or legal person carries out, safely, activities subject to provisions of this law (6) The Commission will review the regulations whenever necessary, in relation to international standards and international conventions ratified in the field and will have the necessary measures to apply them. (7) The Commission shall develop the Regulation of fees and charges for the authorization and control of nuclear activities, whenever necessary, with the opinion of the Ministry of Public Finance and the Ministry of Economy and Trade, which shall be approved by decision of Government. + Article 6 Research, experimentation, development, manufacture, import, export, transit, possession or detonation of a nuclear weapon or of any nuclear explosive device are prohibited on the territory of Romania. + Article 7 The import of radioactive waste and burned nuclear fuel shall be prohibited, except where the import flows directly from the processing, outside the territory of Romania, of an export, previously authorised, of radioactive waste or nuclear fuel burned, based on the provisions of international agreements or contracts concluded with commercial partners based abroad, under the conditions provided for by this Law. + Chapter II Authorisation regime + Section 1 Authorisations and permits for the exercise of nuclear activities for exclusively peaceful purposes + Article 8 (1) The activities and sources provided for in art. 2 2, with the exception of the transport activities of the ionizing radiation generating devices, the use of the dosimetric control equipment and the ionizing radiation detection systems, as well as those provided in lett. h) of the same article, requires authorization issued by the Commission, in compliance with the authorization procedure specific to each kind of activity or sources, in accordance with the provisions of art. 5. (2) The authorization shall be issued to legal entities, at their request, if they prove that they comply with the provisions of this law (3) The authorization may also be issued to units without legal personality, established according to the law, nominated in Annex no. 4 to this law, if they prove that they comply with the provisions of this law (4) The authorization issued by the Commission shall be made on levels of exigency, depending on the associated risks of the activity carried out in accordance with the specific regulations developed by the Commission under the provisions of art. 5. (5) The authorization may be used only for the purpose for which it has been issued, in compliance with the limits and conditions specified therein. (6) The authorizations provided in par. ((1) is requested and, respectively, shall be issued, simultaneously or successively, separately for each type of activity or for each nuclear or radiological installation with its own functionality, of the applicant's patrimony, or for each type distinct from radioactive material, ionising radiation generator, dosimetric control apparatus of ionising radiation or the degree of radioactive contamination, material or device used for the purpose of protection against ionising, means of containerisation or transport radiations specially arranged in this purpose, which the applicant for the production authorisation intends to carry out, for use or marketing. ((7) The authorization of a phase of implementation or operation of any nuclear or radiological installation can only be done if the previous phases have received all the necessary types of permits. (8) Within the meaning of paragraph ((7), the phases of authorisation of nuclear or radiological installations are, where appropriate, the following: a) design; b) location; c) production; d) construction and/or assembly; e) commissioning; f) probationary operation; g) exploitation; h) repair and/or maintenance; i) modification; j) conservation; k) decommissioning. (9) Partial authorisations may be issued for the phases of implementation or operation of nuclear and radiological installations. (10) Partial authorizations, which shall be issued, simultaneously or successively, for one and the same phase of those referred to in par. ((8), may be the provisional decision of the Commission, if the petitioner so requests. In this case they have validity until the issuance of the definitive authorization of that type, but not more than 2 years, with the right of extension, on request, for another 2 years, when all necessary information is not available in due time. (11) The Commission will withdraw the partial authorisation whenever it ascertains the lack of concern of the holder of the authorisation to complete the necessary information in support of the application for the authorisation. + Article 9 (1) The holder of the authorization provided in art. 8 will use in the activities provided in art. 2 lit. a)-c) only personnel who are the holder of an exercise permit, valid for these activities. (2) The exercise permit shall be issued on the basis of the regulations issued according to art. 5. (3) The exercise permit shall be issued, on the basis of an assessment and examination, by the Commission or by the authorisation holder, only for its own staff, in accordance with the provisions of the specific regulations issued by the Commission according to the art. 5. (4) A condition prior to issuing the exercise permit is obtaining the specific medical opinion, based on the regulations issued by the Ministry of Health in accordance with the provisions of art. 5 5 para. ((4). ((5) The opinion of the competent national safety bodies for staff to carry out professional activities, whether permanent or temporary, in the vital work points of the nuclear facilities or having access to the secret documents are required in accordance with the legal provisions in the field and the specific regulations issued by the Commission according to the provisions of art. 5. + Article 10 (1) The authorization and the exercise permit shall be issued for a period determined by the regulations issued according to the provisions of art. 5. (. In the authorisations issued by the Commission for the owner, the user or the operator of the nuclear installations shall explicitly mention its quality. (3) The right acquired on the basis of the authorization and the exercise permit cannot be transmitted without the consent of the issuer. (. In order to issue the authorization or the exercise permit, the applicant shall: a) to pay in the account of the Commission the tariffs for the authorization and control of nuclear activities, in accordance with the regulation provided for in 5 5 para. ((7); b) to pay at the State Treasury the authorization fees, in accordance with the regulation provided in art. 5 5 para. ((7). + Article 11 The authorisations provided for in art. 8 shall be suspended or withdrawn, in part or in full, by the issuer, on its own initiative or upon referral to any natural or legal person, in all cases where the Commission finds that: a) the holder of the authorization did not comply with the provisions of the present law and the specific regulations or limits and conditions b) the measures ordered according to the head are not fulfilled, in full and at the deadline. IV of control bodies empowered by this law; c) new situations arise from a technical or other point of view, unknown at the date of issuance of the authorization, which may affect the safe conduct of nuclear activities; d) the holder of the authorization does not fulfill his legal obligations regarding the establishment of financial sources for the permanent management and storage of radioactive waste and spent nuclear fuel and the decommissioning of nuclear facilities or liability insurance for damages to third parties in the event of a nuclear accident; e) the holder of the authorization ceases to be legally constituted; f) the holder of the authorization loses legal capacity + Article 12 The exercise permit provided for in art. 9 shall be suspended or withdrawn by the issuer, on its own initiative or at the referral of other institutions with control powers, according to this law, or of specialized persons, in all cases where the issuer finds that: a) the holder of the exercise permit did not comply with the provisions mentioned in the regulations issued according to art. 5 5; b) the holder of the exercise permit ceases his or her legal capacity. + Article 13 (. The Commission may supplement, revise or amend, reasoned, the limits and the conditions specified in the authorizations or the exercise permits. (2) If the new conditions imposed according to par. ((1), the provisions of art. 11 11 and 12. + Article 14 The extension of the period of validity of the authorization or the permits to exercise, reauthorize or issue a new permit shall be made under the conditions provided in art. 8 8-10 and in art. 13. + Article 15 (1) The withdrawal, exceptionally, of the authorization provided for in art. 8 8 entitles the holder of the authorisation to receive compensation from the authority which ordered the withdrawal of the authorisation. The amount of the compensation shall be determined taking into account both the public interest and the holder of the withdrawn authorisation and the reasons for the withdrawal of the authorisation. The amount of compensation shall be determined by the agreement of the parties or, in case of misunderstanding, by the court. (. The authorization shall be withdrawn without compensation in the following situations: a) the authorization holder has obtained the authorization making use of false statements; b) the holder of the authorization violated the provisions of this law, the provisions of the authorization and control bodies in the matter or limits and conditions provided for in c) the withdrawal of the authorization was ordered due to the fact that the staff of the holder, third party, population or environment were exposed to risks above the regulated limits, generated by the authorized activity. (3) The provisions of this Article shall also apply under the conditions established according to art. 13. + Article 16 ((1) Activities in which materials with total activity or low mass concentration are used, ionising radiation generators of the type approved by the Commission and any electronic tubes meeting the exemption limits and criteria provided in international standards, so that the risks related to the activity or source are at least accepted, shall be exempted, in part or in full, from the application of the authorization regime provided for in this Law. (2) The limits and detailed criteria for partial or total exemption from the application of the authorization regime will be established by the regulations issued in accordance with the provisions of art. 5. ((3) The exemption from the application of the authorization regime, provided in par. ((1), does not exempt the holder of radioactive sources and materials exempted from their surrender as radioactive waste after the end of use, if the instructions for use of the manufacturer, importer or supplier make it compulsory compliance with this requirement + Article 17 (. Legal persons may request, for the activities they intend to carry out, a preliminary opinion from the Commission, from which, on the basis of the information submitted by the applicant, the classification within the exemption limits provided for in art. 16. (2) If the preliminary opinion does not confirm the classification within the exemption limits, the applicant is obliged to ask for the authorization of the respective activities, in accordance with the provisions of art. 8. ((. The liability for the correctness of the information submitted in support of the request for a preliminary opinion shall be + Section 2 Conditions of authorisation + Article 18 (1) The authorizations provided for in art. 8 8 shall be issued only if the applicant for the authorisation fulfils the following conditions, a) is able to demonstrate the professional qualification, by functions, of its own staff, its knowledge of the requirements of the regulations on nuclear safety and the protection against ionizing radiation, as well as the probity persons having decision-making authority in the management of the works during the construction and operation of the nuclear and radiological installation or in the management of other nuclear activities, of those mentioned in that Article b) respond that personnel who carry out professional activities, of a permanent or temporary nature, in the vital working points of nuclear facilities or who have access to documents of a secret nature to be trustworthy and endorsed according to the law on national security bodies; c) it is able to demonstrate that it has the technical facilities, technologies and material means necessary to carry out the activities; d) show organizational capacity and responsibility in preventing and limiting the consequences of damage, with possible effects with negative impact on the life and health of its own staff, population, environment, property of third parties or on own heritage; e) responds that the rest of its staff, who ensure the operation of the facility, have the necessary level of knowledge specific to the function it performs, on the operation of the nuclear safety facility, the associated risks and the applicable nuclear safety measures; f) take all necessary measures, at the level of the technological and scientific rules in force, in order to prevent the damage resulting from the construction and operation of the nuclear or radiological installation; g) establish an insurance or other financial guarantee covering its liability for nuclear damages, the amount, nature and conditions of the insurance or guarantee being in accordance with the law and international conventions to which Romania is part; h) is responsible for taking the necessary measures to prevent interference of any nature or to remove disturbances due to any third parties in the decision-making process, during construction and during the operation of the nuclear facility; i) proposes a site of the nuclear or radiological installation that does not contravene the legal provisions and priority public interests, regarding the non-compliance of water, air and soil, and does not affect the operation of other installations located in Neighborhood; j) has adequate and sufficient material and financial arrangements for the collection, transport, treatment, conditioning and storage of radioactive waste generated from its own activity, as well as for the decommissioning of the plant nuclear, when it finally ceases the authorized activity, and has paid the contribution for the establishment of financial sources for the permanent management and storage of radioactive waste and spent nuclear fuel and decommissioning nuclear installations; k) establish and maintain a system according to the specific regulations of protection against ionizing radiation; l) establish and maintain a system in accordance with the specific regulations for the physical protection of nuclear fuel, nuclear and radioactive materials, radioactive products and waste, and nuclear installations, including stockpiles nuclear fuel, nuclear and radioactive materials, radioactive products and waste; m) establishes and maintains in its own activity a controlled quality management system, authorised by the Commission, and ensures that both its suppliers of products and services, and their sub-suppliers, in the chain, establish and maintain their own controlled quality management system; n) establish and maintain a system of its own, approved, preparation of the intervention in case of nuclear accident; o) establish and maintain a system in accordance with the regulations for the application of nuclear safeguards; p) holds all other agreements, authorizations and opinions provided by law; q) establishes and maintains an information system of the public in accordance with legal regulations. (2) Establishment and maintenance of the systems provided in par. (1) may also be made by contracting the respective services with other holders, if they are authorized under this law. (3) The conditions of authorization provided in par. (1) and (2) will be detailed in the regulations issued according to art. 5. + Article 19 (1) Nuclear fuel may only be held by legal persons. It is prohibited to hold nuclear fuel without possessing for it the authorization of possession, as well as one of the following authorizations: production, storage, treatment, processing, use, transport, import or export, in agreement with the activities they carry out, issued in accordance with the provisions of art. 18 18 and art. 20-22. (2) The illegally held nuclear fuel is confiscated, becomes public property of the state and surrenders to a custodian, specially designated for this purpose. (3) If the economic operator, holder of the nuclear fuel, is bankrupt declared, the Government may decide, under the present law, to transfer it to an economic operator authorized by the Commission. (4) If the economic operator, holder of radiation sources, nuclear materials or ionizing radiation generators, is in declared bankruptcy, the Commission may order, under the present law, their free takeover. by an economic operator authorised by the Commission with a view to their holding, use, scrapping, processing and disposal, as appropriate. (5) The designation of a holder of authorization as custodian of nuclear fuel shall be made by the issuer of the authorization by express provision in authorization of the obligation to accept nuclear fuel in custody, on behalf of the state. ((6) Obligations concerning retention in custody shall also apply to nuclear fuel burned and to other nuclear materials, with the exception of radioactive waste. (. Nuclear fuel in custody or in authorized storage may be released only if: a) the holder has in advance one of the authorizations provided in par. ((1); b) the nuclear fuel is to be entrusted to an authorized caraus, in order to carry out an authorized transport to an authorized consignee. (8) The custody expenses of the authorization holder will be borne by the holder of the property documents on the nuclear fuel deposited in custody, under a contractual arrangement or, in case of misunderstanding, on the basis of a court decisions. (9) Unevened nuclear fuel through property documents becomes, at the time of the finding, public property of the state. + Article 20 ((1) The transport of nuclear fuel outside the premises of nuclear installations or outside the places where nuclear fuel is kept in custody shall be carried out only by transport agents or carauses authorised for that purpose, in compliance with art. 8 8 and 18. (2) The authorizations provided in par. ((1) shall be issued only if the following conditions are met: a) nuclear fuel is transported in accordance with the national regulations on the transport of radioactive materials, issued according to the provisions of 5 5, and international ones concerning the transport of dangerous goods; b) the choice of mode, time and transport route is not contrary to the public interest. ((. The provisions of this Article shall also apply to nuclear fuel burned, radioactive products and waste and to other nuclear or radioactive materials. + Article 21 The use of means of transport specifically designed for the transport of nuclear fuel, nuclear materials, radioactive products or radioactive waste is only permitted when the authorised carcass is in possession of a authorisations for the means of transport, issued by the Commission. + Article 22 (1) The import, export or transit authorization provided for in art. 8, shall be issued only under the following conditions, as applicable: a) in the activity of decision-making control over import, export or transit operations, for which the authorization is requested, the applicant for the authorization will use persons who prove competence and probity, in accordance with regulations in force; b) in the case of import, the applicant shall undertake to ensure compliance with the provisions of this law, of the regulations issued in accordance with the provisions of 5 and the international commitments made by Romania in the field of nuclear energy, to deliver the products and information only to beneficiaries authorized for this purpose, in accordance with the provisions of art. 8 8 and 18, and to report immediately to the Commission on the entry into the country of imported products and information; c) in the case of export, the applicant for authorization shall obtain from its external partners the necessary guarantees showing that they will not use the products or information exported for purposes that harm the international obligations assumed Romania or national security. It will also demonstrate that the export meets the provisions of this law and other specific regulations. (. The exporter and the importer shall immediately report to the Commission on the exit from, respectively, the entry into the country of the products and information exported or imported. (. The holder of the transit authorization shall immediately report to the Commission both on the entry and on the exit from the country of the transited products. + Article 23 (1) The production, supply or import of those provided in art. 8 8 para. (6) requires, in advance, of a product, model or type authorisation issued by the Commission. The authorization of the product, model or type is not mandatory for those provided in art. 8 8 para. ((6), manufactured and/or lawfully marketed in a Member State of the European Union or legally manufactured in a State which is a signatory of the Agreement on the European Economic Area or in a State with which Romania has concluded an agreement recognition in this regard, if the requirements applicable to them in that State present guarantees equivalent to those on the basis of which the product authorization is granted in Romania. (2) The sursele-yardstick of radiation and measuring instruments in the field of ionizing radiation must have model approval, issued by the Romanian Bureau of Legal Metrology, and be metrologically verified, in accordance with the legal provisions. For the dosimetric equipment produced in the European Union, the calibration and metrological verification carried out by the manufacturer will be accepted. (3) The design, realization, use, possession and verification of measuring instruments in the field of ionizing radiation for the needs of the military shall be authorized by the Ministry of National Defence. + Article 24 (1) It is mandatory to authorise quality management systems in the nuclear field of design, location, procurement, construction, assembly, commissioning, operation, decommissioning or conservation activities for products, services and systems that are classified as important to the security of the nuclear facility. (. The authorization shall be issued by the Commission in accordance with the provisions of art. 8 8 and 18 and with the specific regulations relating to the suppliers of products and services in these categories, as well as to their sub-suppliers, in the chain. (3) The authorization provided in par. ((1) and (2) shall be issued only if the applicant for authorisation meets the following conditions, as applicable: a) is able to demonstrate the professional qualification, function, of its own staff, its knowledge of nuclear safety requirements, as well as the probity of persons who have decision-making authority in the management of the activities that compete in the production of the products, services and systems subject to authorisation; b) responds that the rest of its staff, engaged in the activities that compete in the realization of these products, services or systems, have the necessary level of knowledge regarding the effects of the quality deviations of these products, services or systems on the security of the nuclear facility to be incorporated; c) is responsible for taking the necessary measures to prevent interference of any nature or to remove disturbances due to any third parties in the decision-making process and in carrying out the authorized activities; d) establish and maintain a controlled nuclear quality management system in its own business and ensure that its suppliers of products and services, as well as their sub-suppliers, in the chain, establish and maintain their own system controlled quality management. (4) The conditions of authorization provided in par. (3) will be detailed in the regulations issued in accordance with the provisions of art. 5. + Chapter III Obligations of the authorisation holder and other natural or legal persons + Article 25 (1) Holder of the authorization issued according to art. 8 has the obligation and liability to take all necessary measures to: a) ensuring and maintaining: -nuclear safety, protection against ionising radiation, physical protection, own intervention plans in the event of a nuclear accident and quality assurance for the activities carried out or their associated sources; -strict record of nuclear and radioactive materials, as well as all sources used or produced in its own activity; b) compliance with the limits and technical conditions provided for in the authorization and reporting of any overruns, according to the c) limitation only to the activities for which it was authorized; d) development of its own system of requirements, regulations and instructions that ensure the conduct of authorized activities without unacceptable risks of any nature. ((2) The liability for nuclear damage, caused during or as a result of accidents that may occur by carrying out the activities provided for in the authorization or other activities that have resulted in death, injury to bodily integrity or the health of a person, the destruction, degradation or temporary impossibility of using any good, lies entirely with the holder of the authorization, under the conditions established by law and by the international commitments to which Romania is a party. + Article 26 The holder of the authorisation for carrying out a nuclear activity generating or generating radioactive waste shall be obliged: a) to answer for the management of radioactive waste generated by its own activity; b) to bear the expenses related to the collection, handling, transport, treatment, conditioning and temporary or definitive storage of such waste; c) to pay the legal contribution to the establishment of financial sources for the permanent management and storage of radioactive waste and spent nuclear fuel and the decommissioning of nuclear installations. + Article 27 Holder of the authorization referred to in 8 8 is obliged: a) develop a decommissioning preparation programme and submit it for approval to the Commission; b) to provide proof of payment of the legal contribution to the establishment of financial sources for the permanent management and storage of radioactive waste and spent nuclear fuel and decommissioning of nuclear installations. + Article 28 (1) The expiry of the validity, suspension or withdrawal of the authorisation shall not exempt the holder of the authorisation or who has taken ownership of the materials, nuclear or radiological installations, which have been specified in the authorization, of the obligations provided in art. 25 25-27 times those arising from the conditions laid down in the authorization. ((2) On the cessation of the activity or the decommissioning of nuclear or radiological installations, as well as the transfer, in part or in full, of nuclear and radiological installations, radioactive products or nuclear materials, the holder the authorization is obliged, in advance, to request and obtain, under the conditions provided by law, the authorization of possession, preservation, decommissioning or transfer, as the case may be. (3) The authorization or exercise permit, issued on the basis of the provisions of this law, does not exempt the holder from compliance with the provisions of the legislation in force. (4) The cessation of nuclear activities shall be done in accordance with the provisions of the specific regulations elaborated by the Commission, according to 5. (5) The Commission shall establish, by means of a specific regulation issued in accordance with the provisions of art. 5 5 para. (3), the concrete ways of applying this law whenever its provisions cannot be applied simultaneously with the legal provisions of another nature, in consultation with the public administration authorities in the matter, giving priority to compliance the conditions for the safe deployment of nuclear activities. + Article 29 (1) Individuals and legal persons who extract or process mineral substances associated with uranium or thorium deposits or substances that in the processing technological flow are likely to contain radioactive material shall be required to take measures to check materials and machinery throughout the production cycle, handling, transport and storage, to ascertain whether they present a concentration of radioactive substances or a radioactivity which exceeds, at a time given, the limits of exemption from the regulations provided in art. 16. (2) Natural and legal persons who carry out activities other than those mentioned in par. ((1), in which workers or the population are exposed to radon, toron, their offspring or other ionising radiation, due to the natural environment, and natural or legal persons exploiting aeroplanes are required to take assessment measures to notes whether the activities carried out lead at a time to the irradiation of workers or of the population beyond the limits allowed for the respective activities, according to the specific regulations issued by the Commission according to 5. (3) If the results of the assessments referred to in ((1) and (2) show exceeding the limits or criteria for exemption from the regulations provided in art. 16 16, respectively of the limits provided in par. (2), that activity is subject to the authorization and control regime provided for by this law. + Chapter IV Control regime + Article 30 (1) Preventive, operational and subsequent control of compliance with the provisions of this law and regulations issued in accordance with art. 5 5 shall be carried out by the representatives of the Commission, namely the power of attorney, the applicants or holders of authorisations. The control shall be carried out on the premises where they carry out activities subject to the authorisation regime, in any other place which may relate to these activities or to any other natural or legal person who may carry out activities, holds nuclear or radiological installations, materials, other sources or information provided in art. 2, in any of the following situations: a) in order to issue the requested authorization b) during the period of validity of the authorization, periodically or unannounced; c) on the basis of the notification d) when there could be nuclear or radiological installations, materials, other sources or information or it could be carried out activities between those provided in art. 2. (. The Commission may, where appropriate, order the suspension of the work carried out and the freezing of nuclear and radiological installations, radioactive materials, nuclear materials, materials of nuclear interest or other materials, devices, equipment and information pertinent to the proliferation of nuclear weapons or of other explosive, unauthorised or dangerous nuclear devices in operation or possession. + Article 31 (. Representatives of the Commission, when exercising their control mandate, shall have the following rights: a) have access to any place in which to carry out the activities subject to control; b) carry out the measurements and install the necessary surveillance equipment; c) to request the collection and to receive samples of the materials or products subject, directly or indirectly, to the control; d) to oblige the natural person or the legal person controlled to ensure the fulfilment of the provisions mentioned in a)-c) and to intercede the extension of the control to its suppliers of products and services or to their sub-suppliers; e) have access to all information, technical and contractual data, in any form, necessary to meet the objectives of the control, established in art. 30, in compliance with confidentiality, if the holders so request; f) compel the holder of the authorization to transmit reports, information and notifications, in the form required by the regulations; g) to oblige the holder of the authorization to maintain records, in the required form of regulations, of materials, other sources and activities subject to control and to control these records; h) receive, through the care of the applicant or the holder of the authorization, the necessary protective equipment. (2) Provisions of para. ((1) shall apply, in so far as the international agreements to which Romania is a party provide, and to persons approved by the Government of Romania, who carry out, in the presence of the representatives appointed by the Commission, the controls provided for international. (3) The staff of the Commission who by the nature of the activity is exposed to the action of ionizing radiation is considered personally exposed professionally and benefit from the bonuses granted for working conditions according to the law. The list of staff meeting the conditions of professional exposed personnel, according to the law, is proposed by the Commission and is endorsed by the Ministry of Public Health and the Ministry of Labour, Social Solidarity and Family. + Article 32 ((. Representatives of the Commission shall, for the duration of the check, comply with the applicable conditions of approval as required by the staff of the holder of the authorization. (. After the end of the check, the representatives of the Commission shall a) to conclude a control report in which to record the results of the control, the corrective actions ordered and the deadlines for their resolution; b) to propose the suspension or withdrawal of the authorization or the exercise permit, under the conditions provided by law; c) to propose the complaint of judicial prosecution bodies, in the cases and for the facts provided for in this law; d) order the holder of the authorization the disciplinary sanction of the guilty personnel, under the conditions provided by this law; e) to apply to the holder of the authorization, through persons who, according to his status, represent him in relation to the public authorities, the contravention sanctions provided for in this law for individuals or legal entities; f) to apply the contravention sanctions provided in this law to the personnel who are guilty for committing these contraventions. + Article 33 For the duration of the control, natural persons and legal persons subject to control have the obligation to take all necessary measures to allow the fulfilment in good conditions of the provisions of art. 31 31 and 32. + Article 34 (1) In the exercise of their mandate, the bodies with the right to control nuclear activities, set out in Annex no. 3, have the rights provided in art. 31 31 para. (1) and the obligations and duties provided for in art. 32, within the limits of the powers established by law ((. In the event of disobedience or disobedience to nuclear-related provisions, the Commission may require the competent authorities either to proceed with enforcement or to undertake an investigation. The Commission may request the intervention of representatives of the General Inspectorate of the Romanian Police and its subordinate units to ensure the exercise of the control mandate provided in 31 31 para. ((1). ---------- Alin. ((2) of art. 34 34 has been amended by section 1 1 of art. unique from LAW no. 243 243 of 7 December 2010 published in MONITORUL OFFICIAL no. 828 828 of 10 December 2010. ((3) In the event of an emergency, the Commission may undertake on its own initiative nuclear safety precautionary measures, the expenditure related to this activity to be borne by the Commission budget and to be reimbursed by the holder of the authorisation or the legal or natural person provided for in Annex no 4, which holds the radiological installation or the source of radiation involved, willingly or by forced execution. + Chapter V Duties and liabilities + Article 35 The Commission shall carry out the following a) initiates draft normative acts in its field of competence and issues its own and common regulations with other competent authorities, according to the law; b) endorses all draft normative acts that have implications for the nuclear field; c) approve, according to the law, the intervention plans for nuclear accident cases and participate in the intervention; d) collaborate with the central authority for environmental protection and control the activities of the environmental radioactivity surveillance network; e) require the competent bodies in the field of national security to verify persons with responsibilities in the field of nuclear activities, in accordance with the specific regulations issued according to 5 5; f) in its field of competence may initiate, with the opinion of the Ministry of Foreign Affairs, cooperation actions with the International Atomic Energy Agency (A.I.E.A.), the Nuclear Energy Agency (A.E.N.) and other international organizations specialised; f ^ 1) make the payment of financial obligations to international bodies and organizations, in its field of competence, in accordance with the legal provisions; ---------- Lit. f ^ 1) of art. 35 35 was introduced by art. I of LAW no. 343 343 of 22 December 2015 published in MONITORUL OFFICIAL no. 970 970 of 28 December 2015. g) cooperate, under the law, with similar institutions in other states; g ^ 1) initiates, under the law, the necessary steps to conclude treaties at governmental level, in its field of competence; ----------- Lit. g ^ 1) of art. 35 35 was introduced by art. unique from LAW no. 200 200 of 22 October 2010 , published in MONITORUL OFFICIAL no. 720 720 of 28 October 2010. g ^ 2) conclude treaties, under the law, at a departmental level, in its field of competence; -------- Lit. g ^ 2) of art. 35 35 was introduced by art. unique from LAW no. 200 200 of 22 October 2010 , published in MONITORUL OFFICIAL no. 720 720 of 28 October 2010. h) controls, according to the law, the application of the provisions of international treaties and of the national regulations in force on the control of guarantees, physical protection, illicit trafficking, transport of nuclear and radioactive materials, protection against radiation, nuclear quality assurance, nuclear safety of nuclear and radiological installations, nuclear fuel burning and radioactive waste management and nuclear accident intervention; i) establish and coordinate the national system of record and control of nuclear materials, the national system of record and control of radiation sources and nuclear and radiological installations and the register of radiation doses received by personnel professionally exposed; j) cooperate with other bodies that have, according to the law, attributions in the field of safe operation of nuclear and radiological installations, in correlation with the requirements of environmental protection and of the population; k) ensure that the public is informed of the Commission's l) organize public debates in its field of competence, according to the law; m) constitutes a national contact point for nuclear safeguards, for the physical protection of materials, nuclear and radiological installations, for the prevention and combating of illicit trafficking of nuclear and radioactive materials and for emergencies radiological; n) order the recovery of orphan sources and coordinate recovery activities; o) authorizes the execution of nuclear-specific constructions and exercises state control over the quality of construction within nuclear facilities, as an exception to Law no. 50/1991 on the authorization of the execution of construction works, republished, with subsequent amendments and completions, and Law no. 10/1995 on quality in construction, as amended, which will not apply to nuclear installations; p) performs any other duties, provided by law, in the field of regulations and control of nuclear activities. + Article 36 The procedure for the authorisation and control of nuclear and radiological pressure installations shall be established by specific technical prescriptions, issued by the national boiler and installation authority, with the opinion of the Commission, taking into account the criteria general safe deployment of nuclear activities. + Article 37 (1) The central authority for environmental protection organizes, according to the law, the network of surveillance of environmental radioactivity on the territory of Romania, ensuring the necessary information flow to the integrated system of monitoring the environment (2) The environmental agreements and permits, provided by law, will be issued by the central authority for environmental protection, based on the authorization and control criteria provided by law, supplemented by the authorization and control criteria specific, contained in the regulations issued by this authority, according to art. 5 5, in consultation with the Commission and the Ministry of Public Health, on the surveillance and reporting of discharges of radioactive effluents in the environment, as well as the radioactive contamination of environmental factors. (3) The environmental agreement, provided in par. ((2), is a prerequisite for the issuance by the Commission of the location authorization provided for in art. 8. The environmental authorization provided in par. (2) will be issued after obtaining from the Commission the authorization of trial operation, respectively after the issuance of the operating authorization provided for in art. 8, for situations where the Commission issues an operating licence without having previously issued a probationary authorisation. (4) The central environmental protection authority shall inform, whenever necessary, the Commission and the Ministry of Administration and the Interior of those found in the supervisory activity exercised and cooperate with them in order to establishing the necessary measures + Article 38 (1) The Ministry of Public Health allows a) introduction into the economic and social circuit, with a view to the use or consumption by the population, of products that have undergone irradiation or containing radioactive materials; b) introduction into the medical field, for medical diagnosis and treatment, of closed, open sources of devices generating ionizing radiation and pharmaceutical products containing radioactive materials. (2) The application for authorization shall be made by natural or legal persons who carry out the activities referred to in par. ((1). (3) The Ministry of Public Health shall develop its own authorization and control regulations for this purpose, in compliance with the provisions of art. 5 5 and in consultation with the Commission and the Ministries concerned. + Article 39 (1) The Ministry of Public Health organizes a) according to the law, the network of surveillance of contamination with radioactive materials of food products, on the entire food circuit, including drinking water sources, as well as other goods intended for use by the population. This will ensure the activity of surveillance of the radioactive contamination of these goods and products from the country or from import, intended for use on the territory of Romania; b) the epidemiological system for the surveillance of the health status of the professionally exposed personnel and the hygiene conditions in the units where the nuclear activities are carried out. It also follows the influence of these activities on the health of the population and issues the opinions provided by the regulations in force (2) The Ministry of Public Health shall inform, whenever necessary, the Commission and other ministries concerned of those found in the supervisory activity and shall collaborate with them in order to establish the necessary joint measures. + Article 40 (1) Coordination of intervention preparations in case of nuclear accident, in compliance with the provisions of this law, shall be ensured, according to the law, by the Ministerial Emergency Committee of the Ministry of Administration and Interior, with the cooperation of all specialized bodies of the central and local public administration with powers in the matter. (2) The nuclear accident intervention plan for the site of nuclear installations shall be drawn up by the user, the holder of the authorization, together with all the central and local public authorities and the organizations involved in the preparation and in conducting the intervention in case of nuclear accident, in accordance with the requirements of the regulations issued according to 5. ((3) The intervention plans in case of radiological emergencies caused by nuclear accidents in nuclear installations located on the territory of other states, which may affect through cross-border effects-the territory of Romania, as well as the general plans of Intervention outside the site of nuclear installations on the territory of Romania is elaborated through the care of the General Inspectorate for Emergency Situations of the Ministry of Administration and Interior. (4) The central and local public authorities responsible for the preparation and conduct of the intervention in the event of a nuclear accident shall develop their own plans, correlated with the general intervention plan. (5) The intervention plan provided for in par. (2) shall be approved by the Commission, as referred to in paragraph (3) is approved by the Ministerial Committee for Emergency Situations of the Ministry of Administration and Interior, and those provided in par. (4) is approved by the heads of the central and local public authorities, with the opinion of the General Inspectorate for Emergency Situations of the Ministry of Administration and Interior. (6) The applicability of the intervention plan shall be checked and evaluated periodically: the one referred to in par. (2), by the Commission, and those provided for in par. (3) and (4), by the General Inspectorate for Emergency Situations of the Ministry of Administration and Interior. + Article 41 Import and export operations with dual-use nuclear products and technologies set out in Annex no. 1, it is approved, under the law, by the National Export Control Agency, the national authority in the field of export control of dual-use products and technologies, provided that the import/export authorization issued by the National Commission for the Control of Nuclear Activities. + Article 42 The National Customs Authority of the Ministry of Public Finance will control and admit the entry into the country or exit from the country, based on the authorization issued by the Commission, of the goods for which this law requires authorization. + Chapter VI Sanctions + Article 43 The violation of the provisions of this law attracts material, disciplinary, administrative, criminal or civil liability, as appropriate. + Article 44 (1) Perform an activity between those provided in art. 2, in art. 24 24 para. (1), in art. 28 28 para. ((2) and in art. 38 38 para. (1), without having the appropriate authorization provided for by law, constitutes a crime and is punishable as follows: a) with imprisonment from 6 months to 2 years or with a fine, the activities provided for: art. 2 lit. a) regarding the research, design, possession, location, construction or assembly, preservation of nuclear installations; art. 2 lit. b); art. 2 lit. d) regarding the means of containerization or transport of radioactive materials, specially arranged for this purpose; art. 2 lit. g); art. 24 24 para. ((1) and in art. 38 38 para. ((1); b) with imprisonment from 2 to 7 years and the prohibition of some rights, for the unauthorized performance of some activities provided for in: art. 2 lit. a) regarding the commissioning, test operation, operation, modification, decommissioning, import and export of nuclear installations; art. 2 lit. c), if radiological installations, nuclear or radioactive materials, radioactive waste and radiation generators present a particular nuclear or radiological risk; art. 2 lit. e) and f) and art. 28 28 para. (2), if nuclear or radioactive materials, radioactive waste and radiation generators present a particular nuclear or radiological risk. ---------- Lit. b) a par. ((1) of art. 44 44 has been amended by section 4.2 1 1 of art. 61 of LAW no. 187 187 of 24 October 2012 , published in MONITORUL OFFICIAL no. 757 757 of 12 November 2012. (2) Attempted to the crimes provided in par. ((1) lit. b) is punishable. + Article 45 (1) The removal from operation, in whole or in part, of the surveillance and control equipment installed under the conditions of art. 31 31 para. ((1) lit. b) and para. (2), without having reasons arising from nuclear safety or radiation protection requirements, if the act does not constitute a more serious crime, it is punishable by imprisonment from 3 months to 2 years or a fine. (2) If the act provided in par. (1) is committed at fault, the sentence is imprisonment from one month to one year or fine. (3) The prevention by any means of the access of the representatives of the Commission to any place in which the activities subject to control are carried out constitutes a crime and is punishable by imprisonment from one year to 5 years and the prohibition of some rights. (4) The prevention, without right, in the event of a nuclear accident, of the penetration of intervention personnel in the perimeter of the areas where nuclear activities are carried out constitutes a crime and is punishable by imprisonment from 2 to 7 years and the prohibition of some rights. ((5) The penetration without right, in any way, in a space, room or area delimited and marked in which the nuclear activities referred to in art. 2 lit. a)-f), without the consent of the person who uses them, or the refusal to leave them at their request constitutes a crime and is punishable by imprisonment from one year to 5 years. ---------- Article 45 has been amended by section 6.6. 2 2 of art. 61 of LAW no. 187 187 of 24 October 2012 , published in MONITORUL OFFICIAL no. 757 757 of 12 November 2012. + Article 46 (1) The development, manufacture, possession, import, export, transit or detonation of nuclear weapons or of any nuclear explosive devices shall be punishable by imprisonment from 10 to 25 years and the prohibition of some rights. (2) The attempt is punishable. ---------- Article 46 has been amended by section 6.6. 3 3 of art. 61 of LAW no. 187 187 of 24 October 2012 , published in MONITORUL OFFICIAL no. 757 757 of 12 November 2012. + Article 47 Repealed. ---------- Article 47 was repealed by point (a). 4 4 of art. 61 of LAW no. 187 187 of 24 October 2012 , published in MONITORUL OFFICIAL no. 757 757 of 12 November 2012. + Article 48 The following facts are contraventions: a) non-compliance with the reporting obligations provided for in 25 25 para. ((1) lit. b) and art. 31 31 para. ((1) lit. f); b) non-compliance with the limits and conditions provided in the permits issued in accordance with the provisions of 8 8; c) failure to carry out, within the prescribed period, the provisions given in writing, with acknowledgement of receipt, by the Commission, or by the minutes of control, by its representatives; d) use in the activities provided in art. 2 personnel who do not have the necessary training, unchecked personnel or rejected at regular exams or personnel who do not possess the appropriate exercise permit, provided in art. 9 9; e) the use of personnel who do not prove the necessary knowledge and skills or do not apply them in the work carried out, with implications for the operation of nuclear or radiological nuclear safety installation, on risks associated with or on the applicable nuclear safety measures; f) violation of the provisions of art. 25 25 para. ((1) lit. a) by persons who have the right of decision-making control in the management of the works, during the realization, operation or decommissioning of the nuclear or radiological installation; g) non-compliance with the obligations provided 25 25 para. ((1) lit. d) if unacceptable risks of any kind are generated; h) the use by authorized persons of radioactive materials, ionizing radiation generating devices or nuclear installations entrusted for other purposes or for operations other than those established for the fulfilment of service tasks; i) the exercise of nuclear activities without the appropriate exercise permit provided for in art. 9 9; j) non-solicitation of reauthorization, at the deadline set by specific regulations, before the expiry of the old authorization; k) the unauthorised production and supply of the metering control equipment of the ionizing radiation and of the materials and devices used for the protection against ionizing radiation; l) failure to notify the Commission, at the time limit laid down by the specific regulations, of the theft, the removal of radiological installations, nuclear and/or radioactive materials or of the incident or of the nuclear accident in the nuclear facility; or radiological; m) unauthorized performance of an activity provided in art. 2 lit. c) where the Commission finds that nuclear or radioactive materials, radioactive waste and radiation generators do not pose a particular nuclear or radiological risk; n) violation of art. 16 16 para. ((3); o) violation of art. 25 25 para. ((1) lit. c), of art. 26 26 and 27; p) violation of art. 28 28 para. (2), in cases where the Commission finds that nuclear or radioactive materials, radioactive waste and radiation generators do not pose a particular nuclear or radiological risk; q) non-compliance with 29 29; r) non-compliance with the obligations provided 31 31 para. ((1) lit. e) granting access to Commission representatives. + Article 49 (1) Contraventions provided in art. 48 lit. i) and k) are sanctioned with a fine of 100 lei to 3,000 lei. (2) Contraventions provided in art. 48 lit. a), c), d), e), n) and r) are sanctioned with a fine of 3,000 lei to 10,000 lei. (3) Contraventions provided in art. 48 lit. b), f), g), h), j), l), m), o), p) and q) shall be sanctioned with a fine of 2,000 lei to 20,000 lei. (4) The limits of contravention fines are updated by Government decision. + Article 50 The finding and application of the contraventions shall be made by the representatives of the Commission. + Article 51 Provisions Government Ordinance no. 2/2001 on the legal regime of contraventions, approved with amendments and additions by Law no. 180/2002 , with subsequent amendments and completions, except for the provisions of art. 28 28 para. ((1) and (3), as well as of art. 29, are applicable to the contraventions provided by this law. + Article 52 Nuclear and radiological installations, their components, nuclear fuel, radioactive products, including radioactive waste, explosive nuclear devices or their components, which have been subject to confiscation under the conditions laid down in of the Criminal Code, must be kept in a safe place, under the seal of public authorities, in compliance with the requirements of nuclear safety until the disposition of legal measures on them. ---------- Article 52 has been amended by section 4.2. 5 5 of art. 61 of LAW no. 187 187 of 24 October 2012 , published in MONITORUL OFFICIAL no. 757 757 of 12 November 2012. + Chapter VII Transitional and final provisions + Article 53 Whenever necessary, for state reasons, nuclear fuel and radioactive products can be requisitioned according to the law. + Article 54 Any natural or legal person who has suffered an injury as a result of abuses committed by the Commission or other body provided by this law may complain, within 30 days, to the administrative court. + Article 55 (1) The authorization and permits issued before the entry into force of this Law shall maintain their validity until the stipulated period. (2) The provisions of this Law shall also apply to applications for authorization pending on the date of its entry into force. (3) Any person who on the date of entry into force of this Law carries out activities for which the authorization and control regime provided for the head is applied. II, IV and V of this law, is obliged to apply for authorization, within 6 months from the entry into force of the law, if this was not necessary prior to the entry into force of this law. + Article 56 (1) At the time of Romania's accession to the European Union, the provisions of 2 lit. a), c), e) and f) and art. 8 of this law on import, export and transit to and from European Union states. (2) At the time of Romania's accession to the European Union, the control of nuclear safeguards will be carried out under the EURATOM + Article 57 (1) Until the entry into force of the regulations issued under the provisions of art. 5, the provisions of the regulations issued before the entry into force of this law will apply. (2) The regulations issued under this law shall be published in the Official Gazette of Romania, Part I. + Article 58 Annexes no. 1-4 are an integral part of this law. + Article 59 This law shall enter into force 60 days after its publication in the Official Gazette of Romania, Part I. + Article 60 Law no. 61/1974 on the pursuit of nuclear activities in Romania and Law no. 6/1982 on the quality assurance of nuclear objectives and installations, and any other provisions contrary to this Law, shall be repealed, except for the provisions relating to the promotion and conduct of scientific research in the field of nuclear. + Annex 1 LIST materials, devices, equipment and information pertinent to the proliferation of nuclear weapons and other explosive nuclear devices 1. materials of nuclear interest pertinent to the proliferation of nuclear weapons and other explosive nuclear devices; 2. equipment and related components specially designed or manufactured for nuclear reactors; 3. related equipment specially designed and manufactured for burned fuel reprocessing plants; 4. equipment specially designed or prepared for plutonium conversion plants; 5. related equipment specially designed or manufactured for nuclear fuel factories; 6. related equipment specially designed or manufactured for uranium isotope separation plants; 7. related equipment for plants or plants for the separation of lithium isotopes; 8. related equipment specially designed for plants, for the production or concentration of heavy water, deuterium, tritium and their compounds; 9. test and measurement equipment used to produce explosive nuclear devices; 10. components for explosive nuclear devices; 11. industrial equipment specially designed and prepared for use in the manufacture of materials, devices and equipment referred to in point 1-10 1-10, including nuclear materials; 12. Unpublished specific information referring to the materials, devices and equipment referred to in point (a) 1-11. The detailed list of materials, devices, equipment and information pertinent to the proliferation of nuclear weapons and other explosive nuclear devices, set out in this Annex, shall be determined by Government Decision, with compliance with the provisions of the treaties, agreements, conventions and international agreements to which Romania is a party. + Annex 2 DEFINITIONS to which reference is made in art. 3 3 of law 1. nuclear accident-the nuclear event that affects the installation and causes irradiation or contamination of the population or environment beyond the limits allowed by the regulations in force; 2. nuclear activity-any human practice that introduces additional sources or routes of exposure, extends exposure to a greater number of persons or changes the network of exposure pathways, starting from existing sources, thus increasing the exposure or the likelihood of exposure of persons or the number of 3. competent national authority in the field of nuclear activities for exclusively peaceful purposes-the authority, established by law, with legal competence to regulate nuclear activities for exclusively peaceful purposes, authorizing these activities and control of their deployment; 4 4. authorization-document issued by the national competent authority in the field of nuclear activities, for exclusively peaceful purposes, on the basis of a nuclear safety and control assessment, to a legal person, at its request, for carrying out a nuclear activity; 5. nuclear fuel cycle-the whole of operations comprising the extraction and processing of ores and the enrichment of uranium and thorium, the manufacture of nuclear fuel, the operation of nuclear reactors, the retreatment of nuclear fuel, decommissioning, any management activity of radioactive waste or any research and development activity associated with one of the above-mentioned operations; 6. nuclear fuel-material or a mechanical assembly containing raw material or special fissile material, specially designed for use in a nuclear reactor, for the purpose of nuclear energy; 7. radioactive waste-those materials resulting from nuclear activities, for which no use was provided, containing or being contaminated with radionuclides in concentrations above the exemption limits; 8. devices generating ionizing radiation devices that produce X-rays, neutrons or charged particles; 9. radiological installation-ionizing radiation generator, installation, apparatus or device that extracts, produces, processes or contains radioactive materials, other than those defined in section 1. 10 10; 10. nuclear installation: a) any nuclear reactor, with the exception of the one with which a means of maritime or air transport is equipped to be used as a source of power, whether for propulsion or for any other purpose; b) any plant using nuclear fuel for the production of nuclear materials, including any irradiated nuclear fuel retreatment plant; c) any installation in which nuclear materials are stored, with the exception of depositaries for the transport of nuclear materials. Nuclear installations belonging to a single operator, which are located on the same site, will be considered as a single nuclear facility; 11. technical-support institute-unit with expertise, studies on nuclear installations sites, reactors physics, non-destructive examinations, nuclear safety analyses and assessments, decommissioning of nuclear installations, nuclear quality management, assessments of radioactive waste facilities, as well as research and development studies in the field of nuclear safety, radiation protection, radioactive waste management, natural radioactivity and induced environmental, radioecology and radiobiology, emergencies radiological in case of nuclear accident, in accordance with national and international requirements; 12. nuclear-uranium raw material containing a mixture of isotopes in nature; depleted uranium in isotope 235; thorium; any form thereof, metal, alloy, chemical composition or concentration; 13. materials of nuclear interest-heavy water, graphite, zirconium and other materials which, due to specific nuclear properties, are of particular interest to the nuclear field; 14. Special fissile material-plutonium, uranium 233, uranium enriched in the isotope 233 or in isotope 235; any artificially enriched material in any of the above mentioned isotopes; 15. radioactive material-any material, in any state of aggregation, showing the phenomenon of radioactivity, including radioactive waste; 16. nuclear material-any nuclear raw material and any special fissile material; 17. uranium and thorium ore-mineral substance in the deposit or extracted by mining methods which has a uranium content and/or thorium of more than 0,004%; 18. uranium and thorium mining-prospecting, exploration, opening, preparation and exploitation of uranium and thorium ore, conservation and decommissioning of uranium and thorium mines, including restoration of the environment contaminated by uranium mining and torium; 19. intervention plan-all measures to be applied in the event of a nuclear accident; 20. preparation of uranium and thorium ores-processing of uranium and thorium ores in laboratories of physico-chemical analysis, technological laboratories, pilot plants and industrial plants, conservation and decommissioning of plants processing, including final storage of radioactive waste and restoration of the contaminated environment; 21. radioactive product-any radioactive material obtained during the production or use of a nuclear fuel or any material that has become radioactive by exposure to radiation, except for the radioisotopes that have reached the final stage of preparation and are likely to be used for scientific, medical, special, social, commercial or industrial purposes; 22. vital point of work-an area where nuclear materials, equipment, devices or systems that may be vulnerable to sabotage or theft actions are located; 23. ionizing radiation-any of the following radiation: alpha, beta, gamma, X, neutrons, electrons, protons or other charged particles (not including radio waves, visible, infrared, ultraviolet radiation, as well as laser radiation, ultrasound, etc.); 24. regulations-technical, methodological norms, guidelines, instructions, procedures or technical-organizational conditions regarding the authorization and control of nuclear activities, mandatory in the nuclear field, issued by the competent authority according to art. 5 of the law; 25. Special radiological risk of a nuclear facility, nuclear material, radioactive material, radioactive waste or radiation generator-the possibility that in case of loss of control, a single event of this kind can be collected individual higher than the annual dose limit for a person in the population or a collective dose ten times the annual dose limit for a person in the population; 26. The particular nuclear risk of nuclear material-a nuclear material is considered to have a nuclear risk if it is in total quantities exceeding ten times the exemption values from the authorisation provided for by the Fundamental Security Rules radiological; 27. Nuclear safety-the set of technical and organisational measures intended to ensure the safe operation of nuclear facilities, to prevent and limit their deterioration and to ensure the protection of occupied personnel professional, population, environment and material goods against irradiation or radioactive contamination; 28. controlled quality management system-the quality management system established and maintained in accordance with the specific regulations issued by the commission and which is controlled by it; 29. sources-the ionizing radiation emitter and any radioactive material; 30. orphan sources-sources arising from past practices, illicit or lost traffic, which are not under the control of an authorisation holder; 31. mining plant-the totality of mining works and installations on the surface and underground, through which the extraction and transport of ore and sterile, the aeration and evacuation of waters, including the household installations, are ensured. associated waste, which together make up a mine or a quarry; 32. preparation plant-the totality of the existing constructions and installations on the technological flow, which contribute to the preparation of ores, including the associated waste management facilities; 33. plant for the management of radioactive waste from the mining and preparation of uranium and thorium ores-the totality of the constructions and installations through which the collection, transport, processing, conditioning and final storage of radioactive waste, including: a) the halde or the group of hales belonging to a geological research mine or to an extraction mine of uranium and thorium; b) the radioactive depollution plant of liquid effluents from mining and preparation of uranium and thorium ores; c) final storage pond or other premises specially designed and arranged for the final storage of radioactive waste from the preparation of uranium and thorium ores; 34. uranium ore-substance in the deposit or extracted by mining methods, which has a uranium content of more than 0,004%; 35. Torium ore-substance in the deposit or extracted by mining methods, which has a torium content of more than 0,012%; 36. illicit trafficking-any action involving an unauthorized nuclear activity of possession, transfer, import and export for nuclear materials, of nuclear interest, radioactive materials, equipment and devices pertinent to proliferation nuclear weapons, as well as nuclear and radiological installations. + Annex 3 ORGANS control of nuclear activities 1. National Commission for the Control of Nuclear Activities. 2. The county public health authorities and the city of Bucharest. 3. National Environmental Guard. 4. State Inspection for the Control of Boilers, Recipents under Pressure and Lifting Installations-ISCIR within the Ministry of Economy and Trade. 5. Ministerial Emergency Committee of the Ministry of Administration and Interior. 6. General Inspectorate of the Romanian Police and its subordinate units. ---------- Section 6 of Annex 3 has been amended by section 6.6. 2 2 of art. unique from LAW no. 243 243 of 7 December 2010 published in MONITORUL OFFICIAL no. 828 828 of 10 December 2010. 7. Labour Inspection of the Ministry of Labour, Social Solidarity and Family. 8. National Export Control Agency. 9. National Customs Authority of the Ministry of Public Finance. 10. Romanian Bureau of Legal Metrology. + Annex 4 LIST comprising units without legal personality that may be authorized under the conditions of art. 8 8 para. ((3) 1. Medical offices constituted according to Government Ordinance no. 124/1998 on the organization and functioning of medical offices, republished, with subsequent amendments and completions 2. Free practices for public services related to the medical act, constituted according to Government Emergency Ordinance no. 83/2000 3. Legal units constituted, subordinated to ministries with the prior consent of the legal person to which they belong 4. The legally constituted units of the autonomous regions, national companies or large companies, which have obtained in advance the consent of the legal person to which they belong This list can be completed by Government decision. ___________