l a w - srbatom.gov.rs 36-09.pdf · l a w Оn radiation protection and nuclear safety i. basic...

L A W

ОN RADIATION PROTECTION AND NUCLEAR SAFETY

I. BASIC PROVISIONS

Subject Matter

Article 1

This Law stipulates measures for protection of human life, health and environment from harmful effects of ionising radiation and nuclear safety measures regarding nuclear activities and regulates the conditions for practices with sources of ionising radiation and nuclear materials, as well as radioactive waste management.

The provisions hereof shall not apply to naturally occurring cosmic ionising radiation at the ground level, ionizing radiation from the Earth’s crust and human body unless such radiation has been modified by human activities.

The provisions hereof shall not apply to the nuclear facilities whose construction has been banned under a special legislation.

Bans

Article 2

It is forbidden to perform practices with sources of ionising radiation and nuclear materials without approval prior issued by the Serbian Radiation Protection and Nuclear Safety Agency.

Any research or activity aimed at the development, production and use of nuclear weapons, as well as the use of nuclear materials for the production of nuclear weapons and other explosive devices is forbidden.

Imports in the territory of the Republic of Serbia of radioactive waste and spent nuclear fuel of foreign origin are forbidden.

The installation of radioactive lightning rods is forbidden in the territory of the Republic of Serbia.

The installation of ionising smoke detectors with an ionising radiation source in gaseous state or an ionising radiation source whose decay products are in gaseous state is forbidden.

Meanings of Terms

Article 3

Certain terms used herein shall have the meanings as follows:

1) activity is the number of radioactive material decays per unit of time;

2) accident is an unexpected event, human error, equipment breakdown or other irregularity whose consequences or potential consequences are not negligible from the aspect of radiation protection, nuclear or radiation safety or security;

3) decommissioning is a set of technical and administrative activities performed by the user of a nuclear or radiation facility (except a radioactive waste disposal facility), following the permanent shut-down of such facility, achieving the release of such facilities from any further regulatory control;

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4) decontamination is a procedure for removal or reduction of contamination levels, including the measures for removal of immediate risk of contamination, measures for control of further spread of contamination, isolation and safe removal of sources of contamination, as well as actions related to the assessment of risk for contamination and analysis of environmental damage due to contamination;

5) permit is an official written document issued by the Serbian Radiation Protection and Nuclear Safety Agency for individual act of trade of one or several sources of ionising radiation, radioactive and nuclear materials;

6) environment is a set of natural and manmade values whose interactions make the surroundings that is the living space and life conditions;

7) environmental protection is a set of measures preventing harmful effects of ionising radiation in the environment and removing the consequences of such radiation;

8) radiation protection is a set of measures preventing harmful effects of exposure to ionizing radiation;

9) sources of ionising radiation are substances, devices and facilities that emit or may emit ionising radiation;

10) public exposures are exposures due to an accident or exposures due to authorized practices with sources of ionising radiation except the medical or occupational exposure and exposure to the basic level of naturally occurring radiation (background radiation);

11) ionising radiation exposure is act or conditions resulting in irradiation of a human body by ionising radiation;

12) intervention levels are the levels of expected irradiation which could occur as a result of an accident or chronic ionising radiation exposure when special protection measures shall be undertaken;

13) interventions are systematic, pre-planned measures reducing the existing level of ionising radiation exposure or the possibility of irradiation by ionising radiation as a consequence of an accident;

14) ionising radiation is electromagnetic or particle radiation which may produce ions and cause harmful effects on human life and health and the environment;

15) contamination is an unplanned and undesirable presence of a radioactive material, as well as the process towards its presence on surfaces or in solid, liquid or gaseous bodies (including the human organism), above prescribed limits;

16) use of sources of ionising radiation is possession, working with the sources, production, installation, servicing and storage;

17) licence is an official written document issued by the Serbian Radiation Protection and Nuclear Safety Agency to a legal person or entrepreneur as evidence that all required conditions for performing a radiation practice or nuclear activity have been met;

18) medical exposure is patient exposure and the exposure of persons assisting patients during the medical application of sources of ionising radiation, but not being occupationally exposed persons, as well as persons voluntarily involved in medical research programmes with the application of sources of ionising radiation;

19) radioactivity monitoring is a set of measurements, processing and interpretation of measurement results of radiation and other parameters related to the assessment and control of the public exposure levels;

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20) Illicit trafficking of nuclear and radioactive materials is any reception, possession, supply, use, transfer or disposal of a nuclear or radioactive material in the territory of the Republic of Serbia or on crossing the state border without adequate authorization of the Serbian Radiation Protection and Nuclear Safety Agency;

21) licensee for performing a radiation practice is a legal person or entrepreneur with a licence to perform a radiation practice;

22) licensee for performing a nuclear activity is a legal person with a licence to perform a nuclear activity;

23) nuclear safety is a set of measures ensuring the operational conditions of a nuclear facility, preventing nuclear accidents or alleviating their consequences, that is, reducing radiation risk to the required level;

24) nuclear activities are import, export, use and transport of a nuclear material, exploitation of ores containing a nuclear material, locating, designing, construction, trial run, commissioning, use, permanent shut-down and decommissioning of nuclear facilities and recovery of their sites, as well as radioactive waste management;

25) nuclear material is plutonium except if isotopic concentration of Pu-238 exceed 80%; uranium U-233; uranium enriched in isotopic content of U-235 or U-233; uranium with naturally-occurring composition, with its concentration higher than in the ores or processing residues, as well as the mixture of that materials;

26) nuclear facility is a facility where nuclear materials exist or are used, including the facilities for storage, treatment and disposal of radioactive waste;

27) radioactive waste disposal is a set of actions and activities for permanent storage of radioactive waste;

28) approval or authorisation is a set of operations and activities undertaken by the Serbian Radiation Protection and Nuclear Safety Agency under a prescribed procedure and based on an appropriate application submitted by a legal person or entrepreneur for issuing a licence, permission, certificate or decision on the fulfilment of required conditions for performing an activity or practice as provided for hereunder;

29) the basic level of naturally occurring radiation (background radiation) is total ionising radiation coming from natural sources or sources in the environment not subjected to control;

30) confirmation of notification is an official written document issued by the Serbian Radiation Protection and Nuclear Safety Agency to a legal person or entrepreneur performing practice of low radiation risk, that is, using low activity sources of ionizing radiation;

31) potential exposure is any exposure that is unexpected, and which may be a consequence of an accident at a radioactive source or series of uncontrolled events, including the errors occurring due to handing or equipment breakdown;

32) daughter is a nuclide produced as a result of radioactive decay;

33) registration or notification is an official written document submitted in a required form by a legal person or entrepreneur to the Serbian Radiation Protection and Nuclear Safety Agency in order to give the information on the type of sources of ionising radiation they use, possess or intend to use;

34) naturally occurring radionuclides are radionuclides that occur in the nature, not produced by human activity (uranium, radium, thorium, etc.);

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35) trade of sources of ionising radiation, radioactive and nuclear materials is procurement, sales, import, export, transit and any other means of trade of such materials;

36) occupationally exposed persons are persons working with sources of ionising radiation or who are in the ionizing radiation fields in the course of their work;

37) radiation practice is any activity (operation) with sources of ionising radiation that may cause increased levels of exposure to ionizing radiation of occupationally exposed persons and population;

38) radiation and nuclear security, that is, radioactive and nuclear material security or security of facilities where such materials are stored is a set of measures for preventing unauthorised access, damage, loss, theft and unauthorised trade of radiation and nuclear materials, or facilities where such materials are located;

39) radiation safety is a set of prescribed organizational and technical-technological measures providing the optimal planned exposure and optimal risk of potential exposure to ionising radiation, which is the consequence of using sources of ionising radiation, including radiation protection measures, accident prevention measures, as well as measures for remediation of accident consequences, if any;

40) radiation facilities are facilities where one or several sources of ionising radiation are located, whose irradiation risk is such that it may cause the occupational and public exposure above the required limits;

41) radiation risk is a threatening health effect during ionising radiation exposure, taking into account the probability of such exposure, any safety-related risk, including ecosystems in the environment, which may arise as a result of ionising radiation exposure, presence of radioactive materials, including radioactive waste or their discharge into the environment, loss of control over the nuclear reactor core, nuclear chain reaction, radioactive source or any other source of ionising radiation;

42) radioactive material is a material containing one or several radionuclides whose total and specific activities are above the prescribed limits;

43) radioactive waste is a radioactive material which is not intended for further use;

44) radioactivity is a physical phenomena where atoms spontaneously decay with emission of one or several types of ionising radiation, such as alpha, beta, neutron and gamma radiation;

45) radionuclide is a nuclide or atom with defined atomic number, atomic mass and energy state, which is radioactive;

46) decision is an official written document issued by the Serbian Radiation Protection and Nuclear Safety Agency to a legal person which meets the requirements for performing the radiation protection activity, radiation practice or nuclear activity, or to an entrepreneur who meets the requirements for performing a radiation practice in accordance with this Law;

47) radioactive waste storage is placing of radioactive waste at a location under control of an authorised legal person;

48) specific activity of radioactive material is the activity per unit mass of such material;

49) external exposure is the exposure arising due to the ionising radiation from the sources outside the human body;

50) internal exposure is the exposure arising due to the ionising radiation from the sources within the human body;

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51) radioactive waste management is a set of administrative and operational activities in waste handling, treatment, temporary storage, storage, transport (only within the designated location) and disposal, as well as effluent discharge.

II. RADIATION AND NUCLEAR SAFETY AND SECURITY PROGRAMMES AND RADIOACTIVE WASTE MANAGEMENT

PROGRAMME

Programme Types

Article 4

In order to provide the conditions for implementing the policy in the area of radiation and nuclear safety and security and the policy of radioactive waste management, the Government, at the proposal of the Serbian Radiation Protection and Nuclear Safety Agency, shall pass the Radiation Safety and Security Programme, Nuclear Safety and Security Programme and Radioactive Waste Management Programme in line with the regulation on the strategic assessment of environmental impact.

The Programmes under Paragraph 1 hereof serve to determine long-term plans and objectives regarding radiation protection, nuclear activities and radioactive waste management, as well as the system of control and physical protection of nuclear facilities and nuclear materials in accordance with the standards and principles of the international organizations in these areas, as well as international commitments.

The Serbian Radiation Protection and Nuclear Safety Agency shall deliver the annual report on implementation of Programmes under Paragraph 1 hereof to the Government and the ministry responsible for the radiation protection, the ministry responsible for the nuclear safety and radioactive waste management and the authority responsible for the national security.

III. SERBIAN RADIATION PROTECTION AND NUCLEAR SAFETY AGENCY

Foundation

Article 5

In order to provide the conditions for quality and efficient implementation of radiation protection measures and nuclear safety measures while carrying out radiation practices and nuclear activities, the Government shall found the Serbian Radiation Protection and Nuclear Safety Agency (hereinafter referred to as: Agency), as a by itself regulatory organization performing public authorizations in accordance with the law.

The founding and legal position of the Agency shall be subject to the provisions of the law governing public agencies.

The consent to the official document defining the amount of salaries and the number of employees in the Agency shall be given by the Government.

Agency’s Tasks

Article 6

The Agency is responsible for:

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1) passing the bylaws for implementing this Law;

2) passing the Programme of Systematic Environmental Radioactivity Examination;

3) passing the Programme for Additional Training and Qualification of Occupationally Exposed Persons and Persons Responsible for Radiation Protection;

4) passing the Programme of Early Warning of Emergency

5) preparing the draft Programmes under Article 4 hereof;

6) preparing the draft Action Plan in the Case of an Accident;

7) producing instructions and procedures required for implementing radiation and nuclear safety and security measures;

8) issuing, extending and revoking licences for performing a radiation practice or nuclear activity;

9) issuing and revoking permits for trade of radioactive and nuclear materials;

10) issuing, extending and revoking decisions for legal entities or entrepreneurs on performing radiation protection activities, a radiation practice or nuclear activity;

11) issuing confirmation of notification for sources of ionising radiation;

12) issuing certificates to persons responsible for radiation protection;

13) setting the amount of fees for issuing licenses, permits, decisions, confirmationof registration and other certificates;

14) keeping the registry of applications and issued licenses, permits, decisions, confirmation of notification and other certificates;

15) setting up and maintaining a database (centralised registry) on sources of ionising radiation and their users, occupationally exposed persons, and other data relevant for radiation protection, radiation and nuclear safety and security;

16) keeping the centralised records on nuclear facilities, nuclear materials and radioactive waste and running control over the records kept by users;

17) monitoring the radioactivity levels and their changes and assessing their impact on the population and the environment and in that relation ordering the implementation of required measures and monitoring their execution;

18) publishing the annual report on the exposure levels of the population to ionising radiation in the Republic of Serbia;

19) running the control of the fulfilment of conditions serving as the basis for issued licences, permits and decisions under Items 8), 9) and 10) hereof;

20) ensure the transparency in working on the enforcement of this Law and in the procedure for passing bylaws;

21) delivering to the media, responsible government authorities and the International Atomic Energy Agency the information of relevance for radiation and nuclear safety and security;

22) conducting the cooperation with responsible government authorities in its scope of activities;

23) conducting independently or in coordination with the responsible government authorities the cooperation with the International Atomic Energy Agency

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and other international bodies and the responsible authorities of other countries regarding the enforcement of this Law;

24) giving opinion at the request of the responsible government authorities regarding the joining to the international conventions and other agreements in the field of radiation and nuclear safety and security;

25) performing other operations provided for under the law.

The tasks under Paragraph 1, Items 1), 2), 3), 4), 8), 9), 10), 11), 12), 14), 15), 16), 17) and 21) hereof shall be performed by the Agency as entrusted tasks.

IV. RADIATION PROTECTION

Fundamental Principles

Article 7

Radiation protection in radiation practices, nuclear activities and radioactive waste management shall be based on the following principles:

1) justification of application – conditions and permissibility to perform the present and future radiation practices, nuclear activities and radioactive waste management activities shall be determined and assessed according to the economic, social and other benefit which their performance provides to the society as opposed to the radiation risks that may occur due to their performance, taking into account the best available data on their efficiency or consequences;

2) optimization of radiation protection – every activity must be performed so as to have exposure to ionizing radiation as low as it is objectively achievable given the economic and social factors;

3) individual exposure limitation – radiation practice must be planned so as to have individual exposures always below prescribed limits.

Radiation Protection Measures

Article 8

Radiation protection measures implemented for the purpose of the protection of human lives and health and the environmental protection from the harmful effects of ionising radiation are:

1) systematic environmental radioactivity examination;

2) determination of conditions for production, trade and use of sources of ionizing radiation;

3) provision and use of the equipment and radiation protection devices and control of such protection efficiency;

4) radioactivity monitoring, limiting or banning the production, trade and use of products and production ingredients which are contaminated by radionuclides above the required limits;

5) keeping records on sources of ionising radiation;

6) keeping records on materials and raw materials which in a technical-technological process increase the concentration of naturally occurring radionuclides above the prescribed limits;

7) keeping records on exposure to ionizing radiation of occupationally exposed persons, patients and population;

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8) determination of operational conditions and implementation of required safety measures against the harmful effects of ionising radiation at work;

9) control and monitoring of occupationally exposed persons health status;

10) providing training and qualifications of staff in the area of radiation protection;

11) personal and collective radiation protection of people;

12) implementation and application of measures from the Action Plan in the Case of an Accident;

13) collection, storage, treatment and disposal of radioactive waste;

14) set-up of quality management system for radiation protection measures;

15) radioactivity control of goods on import, export and transit;

16) prevention of the illicit trafficking of radioactive and nuclear materials;

17) decontamination of people, work and living environment.

Systematic Environmental Radioactivity Examination

Article 9

Systematic environmental radioactivity examination (hereinafter referred to as: radioactivity monitoring) shall be performed in order to determine the presence of radionuclides in the environment and to assess the level of public exposure to ionizing radiation in normal circumstances, in case of suspicion of an emergency and during the emergency.

The radioactivity monitoring under Paragraph 1 hereof shall be performed in line with the Programme of Systematic Environmental Radioactivity Examination passed by the Agency.

The Programme under Paragraph 2 hereof determines the places, time intervals, types and methods of systematic environmental radioactivity examination.

The Programme under Paragraph 2 hereof shall be subject to the Government consent.

Conditions for Performing Radioactivity Monitoring

Article 10

Radioactivity monitoring or some examinations within may be performed by a legal person which:

1) has an employee with university degree acquired at university studies in mathematics and natural sciences or technical-technological sciences, with three years of experience in measuring radioactivity in the environmental samples;

2) has an adequate laboratory space for processing, measuring and retention of samples;

3) has standard laboratory equipment for sample preparation;

4) has specific measuring equipment meeting the required metrological conditions;

5) has adequate computer hardware and software;

6) is accredited with the national or international accreditation body.

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The Agency shall stipulate detailed conditions to be fulfilled by the legal person performing operations under Paragraph 1 hereof.

The Radioactivity Monitoring Report

Article 11

The legal person performing radioactivity monitoring undertakes to deliver to the Agency the radioactivity monitoring report not later than 31 May of the current year for the previous year, or immediately in case of an accident or at the request of the Agency.

The assessment of the levels of public exposure to ionizing radiation is done based on the radioactivity monitoring under Article 9 hereof and other examinations at the request of the Agency.

Based on the results of radioactivity monitoring, the Agency shall monitor the public exposure, order urgent measures to be taken in case of increase of radioactivity and do assessment of the doses received by the population.

The Agency shall publish in particular expert publication the annual report on the levels of public exposure to ionizing radiation.

The funds for covering the radioactivity monitoring costs and the assessment of the level of public exposure, as well as the assessment of medical exposure are provided from the Agency’s revenues and the budget of the Republic of Serbia.

Limits of Radionuclide Content

Article 12

Drinking water, foodstuff, feeding stuffs, medicines, general use products, construction materials and other goods shall not be put on the market if they contain radionuclides above the prescribed limits.

The Agency shall stipulate the limits of radionuclide content for the products under Paragraph 1 hereof.

Conditions for Performing Measurements of Radionuclide Content

Article 13

The measurement of radionuclide content in products under Article 12 Paragraph 1 hereof may be performed by the legal person which:







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The Agency shall stipulate detailed conditions to be fulfilled by the legal person performing operations under Paragraph 1 hereof.

Increase of Naturally Occurring Radionuclides Concentrations in the Technical-Technological Process

Article 14

If the concentration of naturally occurring radionuclides increase in a technical-technological process above the limits set for the environmental contamination, the legal person or entrepreneur shall keep the records on the matter and deliver them to the Agency.

The Agency shall stipulate the content and periods for delivering the records under Paragraph 1 hereof and determine the list of legal entities and entrepreneurs who in a technical-technological process face the increases in the concentration of naturally occurring radionuclides above the limits set for the environmental contamination.

The Agency undertakes, based on the delivered records, to assess the degree of threat to human health and the environment and order implementation of the radiation protection measures.

The costs of implementing the radiation protection measures shall be borne by the legal person or entrepreneur under Paragraph 1 hereof.

Programme of Early Warning of Emergency

Article 15

For the purpose of early detection of an accident that threatens or may threaten the territory of the Republic of Serbia, a system for early warning of emergency shall be put in place to provide continual measurements of ambient dose equivalent rate, based on the Programme of early warning of emergency passed by the Agency.

The Programme under Paragraph 1 hereof shall be subject to Government consent.

Conditions for Performing Measurements for the Early Warning of Emergency

Article 16

Measurements for the early warning of emergency may be performed by the legal person which:






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The Agency shall stipulate detailed conditions to be fulfilled by the legal person performing measurements under Paragraph 1 hereof.

The funds for implementing the Programme under Article 15 hereof and measurement costs for early warning of emergency shall be provided from the Agency revenues and the budget of the Republic of Serbia.

Project of the Radiation Safety and Security Measures

Article 17

Project of the radiation safety and security measures is an integral part of technical documentation for facilities where sources of ionising radiation have been or are to be used, and the implementation of which ensures that such facilities meet the required level of protection for the occupationally exposed persons, population and environment from ionising radiation.

The Agency shall stipulate the content of project under Paragraph 1 hereof for each radiation practice.

The Agency shall give its consent to the Project of the radiation safety and security measures.

Conditions for Development of Project of the Radiation Safety and Security Measures

Article 18

Development of Project of the radiation safety and security measures may be performed by the legal person which:

1) has an employee with university degree acquired at graduate university studies in mathematics and natural sciences or technical-technological sciences, with three years of experience in designing radiation protection measures;

2) has an adequate space for computer hardware and project documentation;

3) has computer hardware and software for data evaluation and processing and relevant standardised programmes for designing and calculation for radiation protection measures.

The Agency shall stipulate detailed conditions to be met by the legal person performing the design of radiation safety and security measures.

Measurements for Assessment of Exposure to Ionizing Radiation

Article 19

In order to assess the level of exposure to ionizing radiation of occupationally exposed persons, patients and population, the required measurements are performed in accordance with this Law.

The Agency shall stipulate the types, manner and time intervals of measurements in order to assess the level of ionising radiation exposure of occupationally exposed persons, patients and population.

Measurements to assess the level of ionising radiation exposure of occupationally exposed persons, patients and population are performed by the legal person which:

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1) has an employee with university degree acquired at graduate university studies in mathematics and natural sciences or technical-technological sciences, with three years of experience in measurements to assess the level of ionising radiation exposure;






The Agency shall stipulate detailed conditions to be fulfilled by the legal person performing measurements under Paragraph 1 hereof.

Exposure Assessment of the Occupationally Exposed Persons, Patients and Population

Article 20

The legal person under Article 19, Paragraph 3 hereof undertakes to perform the required measurements under Article 19 hereof and to keep records on performed measurements for purpose of assessment of the exposure level to ionizing radiation of occupationally exposed persons, patients and population and to deliver the report on such measurements to the Agency.

The Agency shall stipulate the content of the report on measurements under Paragraph 1 hereof, the manner of record-keeping, retention time for the records, as well as the notification procedure towards the responsible authorities.

Programme of Additional Training and Specialized Education

Article 21

In order to implement additional training and qualification in the area of radiation protection, the Agency shall pass the Programme of Additional Training and Specialized Education for occupationally exposed persons and people responsible for implementing radiation protection measures and shall publish it in the “Official Gazette of the Republic of Serbia”.

The Programme under Paragraph 1 hereof shall be subject to the Government consent.

Conditions for Providing Additional Training and Specialized Education

Article 22

The additional training and specialized education for occupationally exposed persons and people responsible for implementing radiation protection measures in accordance with the Programme under Article 21 hereof may be performed by the legal person which:

1) has an employee with university degree acquired at graduate university studies in mathematics and natural sciences or technical-technological sciences, with three years of experience in implementing radiation protection measures;

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2) has an adequate space, training aids and the equipment for practical work and conducting the training and education in accordance with the Programme under Article 21 hereof.

The Agency shall stipulate detailed conditions to be fulfilled by the legal person performing additional training and specialized education for occupationally exposed persons and people responsible for implementing radiation protection measures.

Measurements to Control the Quality Management System

Article 23

Measurements to control the quality management system of the radiation protection measures may be performed by the legal person which:

1) has an employee with university degree acquired at graduate university studies in mathematics and natural sciences or technical-technological sciences, with three years of experience in measurements to control the quality management system in terms of the implementation quality of radiation protection measures;





6) applies the accredited examination methods and quality management system.

The Agency shall stipulate detailed conditions to be fulfilled by the legal person performing activities under Paragraph 1 hereof.

Decontamination of Work and Living Environment

Article 24

Decontamination of work and living environment may be performed by the legal person which:


2) has an adequate laboratory decontamination space and space for temporary storage of radioactive waste materials;

3) has personal protection devices;

4) has specific portable measuring equipment meeting the required metrological conditions, as well as adequate decontamination means and equipment;

5) has special-purpose vehicle for transport of radioactive materials.

The Agency shall stipulate detailed conditions to be fulfilled by the legal person performing the decontamination of the work and living environment.

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Decontamination of Persons

Article 25

Decontamination of persons (hereinafter referred to as: human decontamination) may be performed by the legal person which:


2) has an adequate laboratory space for human decontamination and space for temporary storage of radioactive waste materials;


4) has adequate standardized means for human decontamination.

The Agency shall stipulate detailed conditions to be fulfilled by the legal person performing human decontamination.

Authorisation for Performing Radiation Protection Activities

Article 26

Based on the fulfilment of required conditions, the Agency shall authorise under its decision a legal person for performing the activities under Articles 10, 13, 16, 18, 19, 22, 23, 24, 25 and 70 hereof.

The decision on performing activities under Paragraph 1 hereof shall be issued within 30 days after filing the application and documentation proving that the required conditions have been fulfilled.

The decision shall be issued for the five-year period and it shall be non-transferable.

The legal person under Paragraph 1 hereof undertakes to report to the Agency any change in data on the fulfilment of conditions which served as the basis for issuing the decision.

The authorised legal person under Paragraph 1 hereof undertakes, 60 days before the termination of the decision, to file for an extension with the Agency.

The extension of the decision shall be granted for the same period and under the same conditions that served as the basis for issuing the previous decision.

Against the decision issued by the Agency to the legal person in the area of radiation protection, an appeal may be filed to the Minister responsible for radiation protection.

The decision by the Minister under Paragraph 7 hereof shall be final.

The list of authorised legal entities for performing the activities under Paragraph 1 hereof shall be published in the ‘’Official Gazette of the Republic of Serbia”.

The issued decisions shall be subject to record-keeping by the Agency.

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Revocation of Authorization prior to Expiration

Article 27

The Agency shall revoke the authorisation from the authorised legal person prior to expiration of the decision if:

1) the legal person ceases to fulfil any of the required conditions that served as the basis for issuing the decision;

2) the legal person fails to inform the Agency of the accident observed while doing activities in radiation protection;

3) the Agency establishes that the legal person does not perform activities in radiation protection in accordance with this Law, or if within a set time period the legal person fails to remove the faults and failures in their activities;

4) the legal person does not perform the required measurements or conceals the data or delivers false data, relevant for undertaking radiation protection measures.

Records on Performed Activities

Article 28

The authorised legal person under Article 26, Paragraph 1 hereof undertakes to keep records on performed activities in radiation protection and to deliver the records data to the Agency not later than 31 January of the current year for the previous year.

The form and content of the records under Paragraph 1 hereof shall be stipulated by the Agency.

Conditions for Performing a Radiation Practice

Article 29

The legal person or entrepreneur may perform a radiation practice if they fulfil the following conditions:

1) the buildings and premises where sources of ionising radiation are produced, stored or handled meet the technical, safety and other required conditions ensuring the protection of people and the environment from ionising radiation;

2) the people working with sources of ionising radiation are provided with adequate devices for radiation protection, as well as ionising radiation measuring equipment;

3) such employees should be engaged who, depending on the type of radiation practice performed, have the required professional qualification and fulfil the required health conditions for working with sources of ionising radiation;

4) such measures should be implemented which prevent radioactive waste to cause the environmental contamination;

5) radioactive material, x-ray devices and other devices generating ionising radiation should be secured and used and traded with in accordance with the required conditions;

6) other radiation protection measures should also be implemented for performing a radiation practice stipulated under this Law.

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The Agency shall stipulate the detailed conditions under Paragraph 1 hereof to be fulfilled by the legal person or entrepreneur for performing a radiation practice.

Licence for Performing a Radiation Practice

Article 30

Pursuant to the fulfilment of the required conditions under Article 29 hereof, the Agency shall issue to a legal person or entrepreneur the license for performing a radiation practice.

The legal person or entrepreneur may not commence the performance of a radiation practice if they have not previously obtained the licence for performing such radiation practice.

The licence for performing a radiation practice shall be issued under a decision within 30 days following the filing of an application with documentation proving that the required conditions have been met for performing the radiation practice.

The licence for performing a radiation practice shall be issued for the period of five years.

The legal person or entrepreneur undertakes to report to the Agency any change in data on the fulfilment of conditions that served as the basis for issuing the licence for performing a radiation practice.

The legal person or entrepreneur undertakes, 60 days before the expiration of the licence, to file for an extension with the Agency.

The extension of the licence for performing a radiation practice shall be granted for the same period and under the same conditions that served as the basis for issuing the previous licence.

Against the Agency decision on issuing or extension of the licence for performing a radiation practice, an appeal may be filed to the Minister responsible for radiation protection.

The decision of the Minister under Paragraph 8 hereof shall be final.

Person Responsible for Radiation Protection

Article 31

The legal person or entrepreneur having been granted the licence for performing a radiation practice undertakes to nominate a person responsible for radiation protection.

The person responsible for radiation protection undertakes to conduct internal monitoring over the application of radiation protection measures; take care of implementing personal dosimetry control and procurement of protection means; take care of implementing health control over occupationally exposed persons; take care of professional skills of employees for implementing radiation protection measures; take care of regular control over sources of ionising radiation within set timelines; organize that protection measures should be undertaken in case of an accident; ensure record-keeping; attends inspection control and performs other operations concerning sources of ionising radiation as determined by the Agency or that are required according to the provisions hereof.

The person responsible for radiation protection shall have at least the secondary school degree in the adequate profession, work experience in radiation

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protection and additional skills and training in accordance with the Programme under Article 21, Paragraph 1 hereof.

The Agency shall stipulate the professional qualification type and degree for the person responsible for radiation protection, work experience in radiation protection and additional skills and training, depending on the radiation practice.

Based on the fulfilment of the required conditions, the Agency shall issue a certificate to the person responsible for radiation protection.

Confirmation of Notification

Article 32

The legal person or entrepreneur performing a low-risk radiation practice, that is, using sources of ionising radiation with low-level activities does not undertake to obtain a licence for such type of practice, but undertakes to obtain from the Agency the confirmation of notification for such sources.

The Agency shall stipulate the sources of ionising radiation for the use of which the legal person or entrepreneur undertakes to obtain the confirmation of notification, as well as the sources of ionising radiation for the use of which the legal person or entrepreneur does not undertake to obtain the confirmation of notification.

Licensee’s Obligations for Performing a Radiation Practice

Article 33

The licensee for performing a radiation practice undertakes to:

1) regularly maintain and service sources of ionising radiation;

2) keep the required records on sources of ionising radiation;

3) report to the Agency all changes regarding the operation of sources of ionising radiation of relevance for radiation safety and security;

4) report to the Agency the discontinuation of use of sources of ionising radiation, as well as the manner of their temporary storage, storage and the possibility of permanent disposal;

5) report to the Agency any change versus the required conditions that served as the basis for issuing the licence for performing a radiation practice;

6) implement other radiation protection measures provided for under this Law.

Obligations towards Occupationally Exposed Persons

Article 34

The licensee for performing a radiation practice or the licensee for performing a nuclear activity undertakes to provide the occupationally exposed persons with personal dosimetry control, equip them with personal protection means, provide checks of proper operation of these means and their proper use, provide regular health checks as well as additional training and qualification in accordance with the Programme under Article 21 Paragraph 1 hereof.

The licensee under Paragraph 1 hereof undertakes, depending on the type of radiation practice or nuclear activity, to conduct the required measurements under Article 19, Paragraphs 1 and 2 hereof, in order to assess the level of ionising radiation exposure of occupationally exposed persons.

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Radioactive Waste Storing Obligations

Article 35

The licensee for performing a radiation practice or the licensee for performing a nuclear activity undertakes to store the radioactive waste generated as a result of operations in its own temporary storage as required depending on the type of radiation practice or nuclear activity, but not more than one year and not later than on the expiry of the term to hand it over to the licensee for radioactive waste storage facility management.

The Agency shall stipulate the manner of temporary storing of radioactive waste under Paragraph 1 hereof.

Record-Keeping Obligation

Article 36

The licensee for performing a radiation practice or the licensee for performing a nuclear activity undertakes to keep records and deliver to the Agency the required data on sources of ionising radiation, occupationally exposed persons and radioactive waste.

The licensee for performing a radiation practice or the licensee for performing a nuclear activity for medical purposes undertakes, in addition to the records under Paragraph 1 hereof, to keep records on patient exposure to ionising radiation.

The form and content of the records under Paragraphs 1 and 2 hereof shall be stipulated by the Agency.

The Agency shall keep the centralised registry on sources of ionising radiation, licensees, occupationally exposed persons and radioactive waste.

Quality Management Obligation

Article 37

The licensee for performing a radiation practice or the licensee for performing a nuclear activity and authorised legal entities undertake to set up and implement the quality management system for radiation protection measures.

Depending on the radiation practice or nuclear activity performed by the licensee or depending on activities in radiation protection performed by the authorised legal person, the Agency shall stipulate the manner, type and time intervals for measurements in order to control the quality management system for radiation protection measures.

Decontamination Obligation

Article 38

The licensee for performing a radiation practice or the licensee for performing a nuclear activity undertakes forthwith to conduct and bear the costs of decontamination of people, work and living environments which contamination has been caused by the radiation practice or nuclear activity, as well as to bear the administrative costs of establishing the immediate contamination hazard and/or the origin of contamination.

The licensee for performing a radiation practice or the licensee for performing a nuclear activity undertakes to reimburse the implementation costs for the activities

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under Paragraph 1 hereof if a responsible authority has undertaken and implemented them.

The Agency shall stipulate the contamination limits for people, work and living environments and the methods for performing decontamination.

The licensee under Paragraph 1 hereof who is responsible for decontamination, as well as the authorised legal person performing decontamination undertake to deliver the related report to the Agency forthwith.

The Agency shall inform the occupationally exposed persons and the public about potential harmful consequences of ionising radiation exposure due to contamination.

Liability for Incurred Damage

Article 39

The licensee for performing a radiation practice or the licensee for performing a nuclear activity shall be liable for the damage due to radiation practice or nuclear activity in accordance with the principle of objective liability.

In the event when the licensee responsible for contamination cannot be immediately determined, the costs of decontamination and incurred damage necessary to be covered forthwith, shall be borne by the Republic of Serbia.

The licensee established as responsible for contamination undertakes to pay the funds at the amount of decontamination costs into the budget account of the Republic of Serbia.

Working Conditions for Occupationally Exposed Persons

Article 40

Occupationally exposed persons shall have the required professional degree and skills for the work and for implementation of radiation protection measures.

Occupationally exposed persons shall fulfil health conditions and undertake to undergo a medical check prior to starting their employment, during the employment, in case of an accident and if necessary, after the termination of employment in a nuclear facility or working with sources of ionising radiation.

The medical checks of the people under Paragraph 2 hereof shall be performed in a healthcare institution meeting the required conditions in regulations governing healthcare.

The professional qualification degree, skills for the work and implementation of radiation protection measures and the health conditions of occupationally exposed persons shall be stipulated by the Agency.

Bans and Restrictions for Working with Sources of ionising radiation

Article 41

Working with sources of ionising radiation is banned for:

1) persons under 18 years of age;

2) women during pregnancy;

3) women during breast-feeding if they work with open sources of ionising radiation.

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Ionising radiation exposure is forbidden above the limits stipulated for population to persons under 18 years of age, except those older than 16 in the course of the required training during the regal schooling for work with sources of ionising radiation.

The licensee for performing a radiation practice or the licensee for performing a nuclear activity undertakes to provide such protection level so as to prevent the exposure above the limits stipulated for population:

1) of employed women during pregnancy;

2) of employed women during breast-feeding if they work with open sources of ionising radiation.

Exposure Limits

Article 42

Occupationally exposed persons, schooling persons and population shall not be exposed to ionising radiation above the prescribed limits.

The Agency shall stipulate ionising radiation exposure limits for occupationally exposed persons, schooling persons and population.

Radiation Practices and Nuclear Activities in Medicine

Article 43

Radiation practices and nuclear activities in medicine may be performed as required if a medical doctor of relevant specialty makes an assessment of medical justification and approves a diagnostic or treatment procedure with the application of radiation protection principles and measures.

The exposure limits for occupationally exposed persons and population shall not apply to patient exposure for medical purposes.

The conditions for performing a radiation practice or nuclear activity in medicine, as well as the manner of patient protection during medical exposure in order to conduct a diagnostic or treatment procedure shall be stipulated by the Agency.

Assessment of Medical Exposure Level

Article 44

In order to assess medical exposure level of ionising radiation, special measurements shall be performed at the request of the Agency.

The Agency shall stipulate the types and manner of measurement for assessing medical exposure level of ionising radiation.

Ban on Systematic X-Ray Scanning of Population

Article 45

Systematic x-ray scanning of population is forbidden except in special cases if such measure is stipulated by the Ministry responsible for healthcare including the obtained consent of the Agency regarding the fulfilment of radiation protection measures for systematic x-ray scanning of population.

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V. NUCLEAR SAFETY AND SECURITY

Nuclear Safety and Security Measures

Article 46

Nuclear safety and security measures undertaken for all activities regarding nuclear facilities, nuclear materials, radioactive waste, as well as in case of an accident are:

1) provision of the conditions for locating, designing, construction, trial run, commissioning, use, permanent shut-down and decommissioning of nuclear facilities;

2) fulfilment of the criteria for nuclear facility safety evaluation;

3) provision of the conditions for trade and use of nuclear materials;

4) provision and implementation of radiation protection measures in a nuclear facility and its vicinity;

5) stipulating the required conditions to be met by the people working in a nuclear facility;

6) provision of the conditions for collecting, recording, treating, storing and disposing of radioactive waste;

7) physical protection of a nuclear facility;

8) prevention of illicit trafficking of nuclear materials;

9) provision of the conditions for implementing the Action Plan in Case of an Accident.

Conditions for Locating, Designing, Construction, Trial Run, Commissioning, Use, Permanent Shut-down and Decommissioning of

Nuclear Facilities

Article 47

When locating, designing, construction, trial run, commissioning, use, permanent shut-down and decommissioning of nuclear facilities, the following nuclear safety and security measures are undertaken:

1) specifying the required conditions for locating, designing, construction, trial run, commissioning, use, permanent shut-down and decommissioning of a nuclear facility;

2) specifying the required criteria for nuclear facility safety evaluation;

3) specifying the required criteria for trade and use of nuclear materials;

4) specifying the required conditions to be met by the people working in a nuclear facility;

5) provision and implementation of radiation protection measures in a nuclear facility and its vicinity;

6) specifying the required conditions for collecting, recording, treating, storing and disposing of radioactive waste;

7) physical protection and other security measures for a nuclear facility and nuclear materials;

8) implementation and application of the required measures in case of a nuclear accident.

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The Agency shall stipulate the conditions, criteria and measures under Paragraph 1 hereof.

Locating and Construction of a Nuclear Facility

Article 48

A nuclear facility may be built only at the location for which a spatial and urban plans have been passed in accordance with the Programmes under Article 4 hereof, regulations governing planning and construction of facilities and regulations governing the environmental impact assessment procedure.

The Parliament, at the Government request, shall discuss the justification of building a nuclear facility and shall communicate its standpoint to the Government.

Nuclear Facility Management

Article 48а

Nuclear facility management in the Republic of Serbia is an activity of public interest.

To perform the activities under Paragraph 1 hereof, a public company shall be founded.

The funds for founding and operation of the public company under Paragraph 2 hereof shall be the state-owned assets from the institutions whose founder is the Republic of Serbia as follows: buildings, equipment and devices of the Vinča Institute of Nuclear Sciences and Institute for Technology of Nuclear and Other Mineral Raw Materials, which are in the function of performing nuclear facility management activities for which the public company is founded.

Licence for Performing a Nuclear Activity

Article 49

A nuclear facility may be located, designed, built, put into the trial run, commissioned, used, permanently discontinued and its decommissioning launched only with a previously obtained licence for performing a nuclear activity which is issued by the Agency.

The licensee for performing a nuclear activity undertakes to obtain the licence from the Agency for any change or modification during locating, designing, construction, trial run commissioning, commissioning, use, permanent shut-down and decommissioning of a nuclear facility.

The application for the licence under Paragraph 1 hereof and the required documentation shall be submitted by the legal person to the Agency.

With the application for the licence under Paragraph 1 hereof, the applicant shall also deliver the opinion of the authority responsible for the environmental protection regarding the environmental impact assessment for the nuclear facility.

The license under Paragraphs 1 and 2 hereof may be issued after it has been established that all required nuclear safety measures have been met, based on the nuclear safety report and other required documentation which for each and every nuclear activity shall be stipulated by the Agency.

The license under Paragraphs 1 and 2 hereof shall be issued under a decision within 90 days following the license application.

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The license under Paragraph 1 hereof shall be issued for the period of three years.

The decision under which a licence is issued shall be published in the “Official Gazette of the Republic of Serbia”.

The legal person undertakes to report to the Agency any change in data on the fulfilment of conditions that served as the basis for issuing the license for performing a nuclear activity.

The legal person undertakes, not later than 60 days before the expiration of the license for performing a nuclear activity, file for extension with the Agency.

The extension of the license for performing a nuclear activity shall be done for the same time period and under the same conditions that served as the basis for issuing the previous licence.

Against the Agency decision on issuing or extension of the licence, an appeal may be field to the Minister responsible for nuclear safety and radioactive waste management.

The decision of the Minister under Paragraph 12 hereof shall be final.

Nuclear Safety Analysis Report

Article 50

The nuclear safety analysis report under Article 49, Paragraph 5 hereof shall contain:

1) the assessment of potential environmental impact of the nuclear facility and potential environmental event impact on that facility;

2) the description of the nuclear facility under construction or the description of the present state of the nuclear facility (as built drawings);

3) the data on the quality of installed equipment and construction materials, as well as other technical documents about the nuclear facility relating to its current state;

4) the assessment of potential accidents and measures necessary for their prevention, as well as the rehabilitation measures for the consequences in case of an accident;

5) the radioactive waste management plan;

6) the description of physical protection system for the nuclear facility and other security measures;

7) other required documentation.

The nuclear safety analysis report shall be supplemented in line with the changes occurring in the project during construction, trial run, commissioning, use and permanent shut-down of a nuclear facility so that the report always addresses the current state of the nuclear facility.

The nuclear safety report for nuclear facility decommissioning shall be continually review and supplemented in line with the changes at the location and nuclear facility, changes in the technology or required procedures arising in the decommissioning process.

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Application of Standards and Technical Regulations

Article 51

A nuclear facility is designed, built, put into trial run, commissioned, used, maintained and permanently shut-downed according to the required standards, technical regulations and product and service quality codes ensuring the required nuclear safety and security of the facility.

The materials and equipment for construction and maintenance of the nuclear facility shall correspond in terms of quality to required standards, technical regulations and quality codes, and service quality during construction and maintenance of such facilities shall correspond to the required regulations.

Trial run, Commissioning and Use of a Nuclear Facility

Article 52

The operation of a nuclear facility shall run according to the operational and other technical instructions applying to all operational regimes, nuclear material handling and their transport, maintenance and monitoring of the technical systems, internal control and procedures in case of an accident.

The licensee for performing a nuclear activity undertakes, as provided for under this Law, to pass and apply the instructions and other official documents relating to the nuclear facility operation, in particular:

1) the operation and procedures during commissioning, regular operations and stopping the operation of the nuclear facility or its parts;

2) the operation and procedures during maintenance, repairs, inspections, and technical inspections of equipment;

3) the operation and procedures for handling radioactive waste materials;

4) the monitoring procedures for radioactivity in the nuclear facility and its vicinity;

5) the organization, operation and radiation protection measures in the nuclear facility and the first aid department;

6) the programme for providing quality works and equipment for safe operation of the nuclear facility;

7) the plan and programme of measures in case of a nuclear accident and other accidents in the nuclear facility;

8) the programme of measures and procedures in case of permanent shut-down of the nuclear facility;

9) the employee training programme.

For the instructions and other official documents under Paragraph 2 hereof the licensee undertakes to obtain a prior consent from the Agency.

Reporting Obligation towards the Agency

Article 53

The licensee for performing a nuclear activity undertakes to deliver o the Agency the reports on:

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1) any change in procedure intended or made under Article 52 Paragraph 2 Item 1) hereof, for the equipment or ways of work for which the conditions or operational restrictions have been stipulated;

2) equipment breakdowns and accidents on the nuclear facility and undertaken measures to remove the consequences of the accident;

3) human error in nuclear facility management;

4) exceeding the required quantities and discharges of gaseous or liquid radioactive waste materials or on deviating from the required conditions under which such materials may be discharged;

5) other circumstance of relevance for the nuclear facility safety and security.

The licensee under Paragraph 1 hereof undertakes to deliver to the Agency regular reports on the nuclear facility operation within the timelines and as stipulated by the Agency.

The licensee under Paragraph 1 hereof undertakes, at the Agency request, to deliver any information on undertaken nuclear safety measures and all other activities regarding the enforcement of this Law.

Permanent shut-down and Decommissioning of a Nuclear Facility

Article 54

In case of permanent shut-down and decommissioning of the nuclear facility, the licensee for performing a nuclear activity undertakes, within the period as set by the Agency, to perform adequate rehabilitation measures at the location and facility and its vicinity.

Radiation protection Service

Article 55

The licensee for performing a nuclear activity undertakes to set up the radiation protection service.

Systematic Environmental Radioactivity Examination in the Vicinity of a Nuclear Facility

Article 56

The licensee for performing a nuclear activity undertakes, in the required manner and according to the required conditions, to perform systematic environmental radioactivity testing in the vicinity of the nuclear facility.

The Agency shall stipulate the manner and conditions for systematic environmental radioactivity testing in the vicinity of the nuclear facility.

Systematic environmental radioactivity testing in the vicinity of the nuclear facility shall be funded by the owner of the nuclear facility.

Conditions for Persons Handling Nuclear Materials

Article 57

Nuclear materials may be handled only by the persons qualified to handle such materials.

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The Agency shall stipulate the conditions to be met by the persons under Paragraph 1 hereof.

The persons who are not qualified to handle nuclear materials or radioactive waste may under the supervision of the qualified persons only transfer, load, unload and store such materials and only if they have been previously made aware of the ways of work, hazards and protection measures.

Nuclear Material Records and Control

Article 58

The licensee producing, reprocessing, using or storing nuclear materials undertakes to keep the required records on such materials in accordance with the ratified international agreements and to deliver the records data to the Agency.

The Agency shall stipulate the manner of keeping the records on nuclear materials under Paragraph 1 hereof.

The Agency shall keep the centralised records on nuclear materials and control the records kept by the licensee under Paragraph 1 hereof.

Control and Supervision by the International Atomic Energy Agency

Article 59

The licensee for performing a nuclear activity undertakes to allow the representatives of the International Atomic Energy Agency, in accordance with the international agreements, to conduct the control and supervision over the nuclear materials under Article 58 hereof.

For the purpose of conducting the control and supervision under Paragraph 1 hereof, the license for performing a nuclear activity undertakes to provide:

1) the place and installations for set-up and smooth operation of the required equipment for nuclear material control;

2) placing seals and other required equipment for the control and supervision over nuclear materials.

The licensee under Paragraph 1 hereof undertakes to provide the integrity of the seal and the conditions for smooth operation of the equipment for nuclear material control and supervision.

Integrated Quality Management System

Article 60

The licensee for performing a nuclear activity shall put in place and implement an integrated quality management system.

The licensee under Paragraph 1 hereof undertakes methodically and systematically to apply the measures of the integrated quality management system to ensure that all technical, construction, organizational and human factors are under control, from the identification of safety requirements to the assessment of the fulfilment of such requirements.

The Agency shall stipulate the manner, types and time intervals for conducting the control of measures under Paragraph 2 hereof.

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Nuclear Facility Security

Article 61

The nuclear facility owner undertakes to provide physical protection and other security measures for the nuclear facility, nuclear material and radioactive waste, including the security measures during transport of nuclear materials.

The licensee for performing a nuclear activity undertakes to pass an official general document on the security measures for the nuclear facility, nuclear material and radioactive waste.

The Government shall stipulate the security measures for nuclear facilities and nuclear materials and monitor their implementation in accordance with the Radiation and Nuclear Safety and Security Programmes.

VI. PROCEDURE IN CASE OF AN ACCIDENT

Action Plan in Case of an Accident

Article 62

To protect the human lives and health and the environment in case of an accident, the Government shall pass the Action plan in case of an accident.

The Plan under Paragraph 1 hereof shall stipulate intervention and derived intervention levels of ionising radiation exposure and protection measures for population and the environment from harmful effects of ionising radiation, the manner of public notification, as well as an operational programme for implementing the whole plan or its parts.

The accident threatening the territory of the Republic of Serbia shall be declared by the Government, as proposed by the Agency.

The protection of human lives and health and the environment from ionising radiation in an accident shall be implemented according to the required measures for prevention and removal of the consequences caused by such event.

If it is established that there is a contamination spreading hazard from the territory of the Republic of Serbia to the neighbouring countries, the Government shall inform of such hazard the International Atomic Energy Agency and the responsible authorities of the neighbouring countries.

The Action plan in case of an accident and activities undertaken shall be implemented in line with the Convention on Early Notification of a Nuclear Accident and Convention on Assistance in the case of a Nuclear Accident or Radiological Emergency.

The Government shall decide on accepting the assistance from other countries and the International Atomic Energy Agency and on providing assistance to other countries in case of an accident.

VII. RADIOACTIVE WASTE MANAGEMENT

Procedure with Radioactive Waste

Article 63

The licensee for performing a radiation practice or licensee for performing a nuclear activity undertakes to collect, keep, record and store radioactive waste in the

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required manner and according to the required conditions. The licensee undertakes to:

1) ensure that the buildings and premises where radioactive waste is collected, kept, recorded and stored meet the technical, safety and other required conditions ensuring the protection of people and the environment from ionising radiation;

2) implement the measures preventing radioactive waste to cause the environmental contamination;

3) secure the stored radioactive or nuclear material.

The Agency shall stipulate detailed manner and conditions for keeping, collecting, recording, storing, treating and disposing of radioactive waste.

Radioactive Waste Storage

Article 64

The Republic of Serbia takes care of temporary storage and permanent disposal of radioactive waste.

Radioactive waste, until the conditions have created for its permanent disposal, shall be temporarily stored with a legal person with the license for radioactive waste storage facility management.

The licensee for radioactive waste storage facility management undertakes to keep records on radioactive waste and deliver the records data to the Agency within the periods and as stipulated by the Agency.

The licensee under Paragraph 2 hereof shall take part in the costs of permanent disposal of radioactive waste.

The amount of costs under Paragraph 4 hereof shall be stipulated by the Government.

VIII. TRADE OF SOURCES OF IONISING RADIATION, RADIOACTIVE AND NUCLEAR MATERIALS

License for Performing the Activity of Trade of Sources of Ionising Radiation, Radioactive and Nuclear Materials

Article 65

The activity of trade of sources of ionising radiation, radioactive and nuclear materials may be performed by the legal person or entrepreneur meeting the conditions under Article 29 hereof and who owns the licence for performing the activity of trade of sources of ionising radiation, radioactive and nuclear materials.

The license under Paragraph 1 hereof shall be issued in the manner and according to the procedure for issuing the license for performing a radiation practice.

Permit for Trade of sources of ionising radiation, Radioactive and Nuclear Materials

Article 66

The trade of one or several sources of ionising radiation, radioactive and nuclear materials may be performed only with a prior permit obtained from the Agency.

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The Agency shall issue the permit for trade of one or several sources of ionising radiation, radioactive and nuclear materials only if the trade is performed for the user with the license for performing a radiation practice, or nuclear activity in accordance with the international standards and in accordance with the Law on Ratification of Vienna Convention on Civil Liability for Nuclear Damage.

With the application for the circulation permit under Paragraph 2 hereof, the legal person or entrepreneur undertakes to submit the documentation stipulated by the Agency.

The trade of sources of ionising radiation, radioactive and nuclear materials imported in the free zones of the Republic of Serbia shall be subject to the provisions of Paragraphs 1 to 3 hereof.

Import, Export and Transit of Sources of ionising radiation, Radioactive and Nuclear Materials

Article 67

The Agency shall issue the permit to the legal person or entrepreneur performing import, export or transit of one or several sources of ionising radiation, radioactive and nuclear materials if measures required under this Law have been undertaken and if such trade is done in line with the adopted international conventions.

The Agency shall issue the permit to the legal person or entrepreneur performing export of one or several sources of ionising radiation, radioactive and nuclear materials only if the importer has obtained the consent from the responsible government authority of the importing country for such import.

If the exporter under Paragraph 2 hereof must make a return of one or several sources of ionising radiation, radioactive and nuclear materials at the request of the responsible government authority of the importing country, the Agency shall issue them a permit for such type of trade.

Import, export or transit of one or several sources of ionising radiation, radioactive and nuclear materials may be performed only through the customs checkpoints with organized inspection control.

The importer of one or several sources of ionising radiation, radioactive and nuclear materials undertakes to inform the Agency on the shipment arrival at least 60 days prior to the shipment reaching the customs checkpoint.

The customs authorities may custom clear one or several sources of ionising radiation, radioactive and nuclear materials only with the consent of an inspector for radiation protection, or inspector for nuclear safety and radioactive waste management.

Transport

Article 68

The transport of sources of ionising radiation, radioactive and nuclear materials in the territory of the Republic of Serbia is performed in accordance with the regulations governing the transport of hazardous substances and international conventions or agreements regarding transport of hazardous substances.

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Bans on Import, Export and Transit of Goods

Article 69

The import of food, drinking water, feed, fertilizers, drugs, general use products, construction materials, ores, primary metal products, mineral raw materials, secondary raw materials and other goods is forbidden if they contain radionuclides above the prescribed limits.

The export of secondary raw materials is forbidden if they contain radionuclides above the required limits.

The transit of secondary raw materials and metal goods through the territory of the Republic of Serbia is forbidden if they contain radionuclides above the required limits.

Radioactivity Control of Goods

Article 70

The Agency shall stipulate the methods and manner of controlling radioactivity of the goods under Article 69 Paragraph 1 hereof.

The determination of radionuclide content in the goods under Article 69 hereof may be performed by the legal person which meets the conditions under Article 10 hereof.

Detailed conditions for performing the activities under Paragraph 2 hereof shall be stipulated by the Agency.

The customs clearance of the goods under Article 69 hereof may be performed only if the responsible inspector establishes that such goods meet the required conditions.

Exceptionally, the customs clearance of some goods under Article 69 hereof (construction materials, ores, primary metal products, mineral raw materials, secondary raw materials, and other goods) may be performed against a delivered report by the authorised legal person on radioactivity control of such goods if the measured content of radionuclides is below the required limits.

The goods imported into free zones or stored into storage facilities in the Republic of Serbia shall be subject to the provisions under Paragraphs 4 and 5 hereof.

Measures for Detecting and Preventing Illicit Trafficking with Radioactive and Nuclear Materials

Article 71

In order to detect and prevent illicit trafficking with radioactive and nuclear materials over the borders of the Republic of Serbia, the monitors shall be placed at border crossings for measuring ionising radiation (hereinafter referred to as: monitors).

The Agency shall stipulate a procedure for using the monitors and a procedure for intervention in case of illicit trafficking with radioactive and nuclear materials over the borders of the Republic of Serbia.

The procurement, installation, use and maintenance of the monitors shall be funded from the budget of the Republic of Serbia.

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IX. LIABILITY FOR NUCLEAR DAMAGES

Nuclear Damage

Article 72

The licensee for performing a nuclear activity shall be liable for nuclear damage caused in a nuclear accident in accordance with the Law on Ratification of Vienna Convention on Civil Liability for Nuclear Damage and this Law.

Nuclear Damage Insurance

Article 73

The licensee for performing a nuclear activity shall conclude and maintain the insurance coverage for its nuclear damage liability.

The insurer shall not suspend or cancel the insurance unless they have informed the licensee for performing a nuclear activity in writing at least six months before such insurance suspension or cancelation.

Indemnification Periods

Article 74

The right to indemnification of nuclear damage shall cease after the ten-year period has expired from the day of a nuclear accident.

If the nuclear damage was caused by a nuclear accident in connection to a nuclear material which at the time of the nuclear accident was stolen, lost, thrown overboard or abandoned, the period under Paragraph 1 hereof shall run as of the day of the nuclear accident and last for 20 years as of the day the material was stolen, lost, thrown overboard or abandoned.

Claim for Nuclear Damage and Court Jurisdiction

Article 75

The claim for nuclear damage may be lodged within three years as of the day when the legal person or natural person having suffered the nuclear damage discovered or should have discovered the nuclear damage and the licensee for performing a nuclear activity that is responsible for it, but not later than until the expiration of periods under Article 74 hereof.

The decision on the indemnification for a nuclear damage shall be subject to the territorial jurisdiction of the court in whose area the nuclear facility is located.

If a nuclear damage occurs during the transport of a nuclear material it shall be subject to the territorial jurisdiction of the court in whose area the nuclear accident occurred.

X. CONTROL

Control Competence

Article 76

Inspection control over implementing radiation protection measures shall be performed by the Ministry responsible for radiation protection through the inspector for radiation protection.

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Inspection control over implementing nuclear safety measures shall be performed by the Ministry responsible for nuclear safety and radioactive waste management through the inspector for nuclear safety and radioactive waste management.

Control over Performing Entrusted Operations

Article 77

The control over the Agency work in performing the entrusted tasks under Article 6 Paragraph 2 hereof shall be performed, within its scope, by the Ministry responsible for radiation protection and the Ministry responsible for nuclear safety and radioactive waste management, in accordance with the regulations governing the government administration.

Rights and Obligations of the Inspector for Radiation protection

Article 78

In performing inspection control over implementing radiation protection measures the inspector for radiation protection has the right and obligation to establish:

1) whether the conditions have been met for performing a radiation practice;

2) whether the conditions have been met for performing activities in radiation protection;

3) whether the required radiation protection measures have been implemented for occupationally exposed persons, population and the environment;

4) whether the required radiation safety and security measures have been implemented;

5) whether other measures provided for under this Law have been implemented.

Authorisations of the Inspector for Radiation protection

Article 79

In performing the operations under Article 78 hereof the inspector for radiation protection is authorised to:

1) order that the faults regarding the work with sources of ionising radiation

should be removed

2) suspend the work with sources of ionising radiation until the required

conditions have been met

3) forbid the production, trade of and use of sources of ionising radiation until

the required conditions have been met

4) forbid the work with sources of ionising radiation for the people not meeting the required conditions;

5) order that the established faults should be removed and the required conditions should be met by the legal entities performing activities in radiation

protection

6) forbid that the authorised legal person should perform activities in

radiation protection until they have removed faults or met the required conditions

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7) forbid the trade of sources of ionising radiation over the border of the

Republic of Serbia until the required conditions have been met

8) order that the established faults should be removed and the required conditions should be met for the radioactivity control of goods;

9) forbid that the authorised legal entities should control the radioactivity of goods;

10) forbid the import, export and transit of the goods which are established to contain radionuclides above the prescribed limits and order that they should be returned to the sender;

11) order decontamination of work and living environments, as well as human

decontamination

12) order that the required records should be kept

13) order the required storage of radioactive waste;

14) order that the required conditions should be met and other faults removed for which is established that they may cause harmful consequences to the human health, work or living environment;

15) order other measures in case of failure to meet radiation safety and security measures.

Rights and Obligations of the Inspector for Nuclear Safety and Radioactive Waste Management

Article 80

In performing the inspection control over implementing nuclear safety measures, the inspector for nuclear safety and radioactive waste management has the right and obligation to establish:

1) whether the conditions have been met for performing a nuclear activity;

2) whether the required nuclear safety and security measures have been implemented;

3) whether other measures provided for under this Law have been implemented.

Authorisations of the Inspector for Nuclear Safety and Radioactive Waste Management

Article 81

In performing the operations under Article 80 hereof, the inspector for nuclear safety and radioactive waste management is authorised to:

1) forbid the designing, construction, trial run, commissioning, use, permanent shut-down and decommissioning of a nuclear facility if the required nuclear safety and security measures have not been met;

2) forbid the trade of nuclear materials if the required conditions have not been met;

3) forbid the work of persons in a nuclear facility if they have not met the required conditions;

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4) order that the required conditions should be met and other faults removed for which is established that they may cause harmful consequences to the human health, work or living environment;

5) order that faults should be removed regarding radioactive waste management;

6) order that faults should be removed regarding the measures for physical protection and technical protection and security of nuclear facilities;

7) control the implementation and application of required measures in case of an accident;

8) order other measures in case of the failure to meet nuclear safety and security measures.

Undertaking Measures in Inspection Control

Article 82

The licensee for performing a radiation practice or licensee for performing a nuclear activity undertakes to allow the inspector for radiation protection or the inspector for nuclear safety and radioactive waste management without delay to look into the documentation, smooth operation and to provide them with the data and material necessary for conducting inspection control.

The measures which during inspection control are ordered by the inspector for radiation protection or the inspector for nuclear safety and radioactive waste management shall be stipulated under a decision.

Against the decision of the inspector for radiation protection, an appeal may be lodged to the Minister responsible for radiation protection.

Against the decision of the inspector for nuclear safety measures and radioactive waste management, an appeal may be lodged to the Minister responsible for nuclear safety and radioactive waste management .

The decision of the Minister under Paragraphs 3 and 4 hereof shall be final.

The appeal to the decision shall not suspend its execution.

Inspector’s ID

Article 83

The inspector for radiation protection or the inspector for nuclear safety and radioactive waste management shall have an official ID.

The Minister responsible for radiation protection shall stipulate the form and appearance of the official ID for the inspectors for radiation protection.

The Minister responsible for nuclear safety and radioactive waste management shall stipulate the form and appearance of the official ID for the inspectors for nuclear safety and radioactive waste management.

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XI. PENALTY PROVISIONS

Economic Offences

Article 84

The fine amounting from RSD 1,500,000 to 3,000,000 shall be imposed for an economic offence on a legal person if such legal person:

1) performs an activity with sources of ionising radiation and nuclear materials without a prior approval issued by the Agency (Article 2, Paragraph 1);

2) conducts research for the development, production and use of nuclear weapons or if uses a nuclear material for the production of nuclear weapons and other explosive devices (Article 2, Paragraph 2);

3) imports into the territory of the Republic of Serbia radioactive waste or spent nuclear fuel of foreign origin (Article 2, Paragraph 3);

4) installs a radioactive lightning rod or ionising smoke detectors with an ionising radiation source in gaseous state or an ionising radiation source whose decay products are in gaseous state (Article 2, Paragraphs 4 and 5);

5) puts into the market drinking water, foodstuffs, feeding stuffs, medicines, general use products, construction materials and other goods containing radionuclides above the prescribed limits (Article 12, Paragraph 1);

6) commences performing a radiation practice without a previously obtained license from the Agency (Article 30, Paragraph 2);

7) causes contamination of people, work or living environments, without conducting an immediate decontamination and immediately report on the matter to the Agency (Article 38, Paragraphs 1 and 4);

8) exposes occupationally exposed persons, schooling persons or population to ionising radiation above the prescribed limits (Article 42, Paragraph 1);

9) locates, designs, constructs, starts a trial run, commissions, uses, permanently shuts down nuclear facility or decommissions the nuclear facility without a prior licence obtained from the Agency (Article 49, Paragraph 1);

10) in case of shut-down and decommissioning of the nuclear facility fails to conduct adequate remediation measures at the location and nuclear facility and its vicinity (Article 54) within the set time interval;

11) fails to keep the required records on the nuclear materials produced, reprocessed, used or stored or fails to deliver the records data to the Agency (Article 58, Paragraph 1);

12) fails to allow the control and supervision over its nuclear materials to the representatives of the International Atomic Energy Agency in accordance with the international agreements (Article 59, Paragraph 1);

13) for the purpose of conducting the control and supervision over nuclear materials fails to provide the place and installations for set-up and smooth operation of the required equipment for the control of nuclear materials and placing a seal and other required equipment for the control and supervision of nuclear materials and fails to provide the conditions for the seal integrity and smooth operation of the equipment (Article 59, Paragraphs 2 and 3);

14) fails to provide physical protection and other security measures for the nuclear facility, nuclear material or radioactive waste or fails to pass an official

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general document on security measures for the nuclear facility, nuclear material and radioactive waste (Article 61, Paragraphs 1 and 2);

15) collects, treats, stores or disposes radioactive waste contrary to the required manner and required conditions (Article 63, Paragraph 1);

16) performs the practice of trade of sources of ionising radiation, radioactive and nuclear materials without the previously obtained license for performing the trade of sources of ionising radiation, radioactive and nuclear materials (Article 65, Paragraph 1);

17) for trade of the one or several sources of ionising radiation, radioactive and nuclear materials has failed to obtain the license for performing the trade of one or several sources of ionising radiation, radioactive and nuclear materials (Article 66, Paragraph 1).

For the economic offence under Paragraph 1 hereof, a fine may be imposed proportional to the amount of damage, non-performance of obligation or value of goods or other item subject to the economic offence, but up to twenty times the amount of the damage, non-performance or value of goods or other item subject to the economic offence.

For the economic offence under Paragraph 1 hereof, the responsible person of the legal person shall be also fined the amount from RSD 100,000 to 200,000.

Article 85

The fine amounting from RSD 1,000,000 to 2,000,000 shall be imposed for an economic offence on the legal person – the licensee for performing a nuclear activity if they fail to conclude and maintain the insurance coverage for its nuclear damage liability.

For the economic offence under Paragraph 1 hereof, the responsible person of the legal person - the licensee for performing a nuclear activity shall be also fined at the amount from RSD 80,000 to RSD 150,000.

Violations

Article 86

The fine amounting from RSD 500,000 to 1,000,000 shall be imposed for a violation on a legal person if such legal person:

1) fails to deliver to the Agency the environmental radioactivity monitoring report within the require period, or immediately in case of an accident or at the request of the Agency (Article 11, Paragraph 1);

2) fails to keep the records on naturally occurring radionuclides whose concentration increases during the technical-technological process of production above the required limits and fails to deliver such records to the Agency (Article 14, Paragraph 1);

3) fails to conduct the required measurements for assessing the level of ionising radiation exposure of occupationally exposed persons, patients and population and fails to keep the records on performed measurements for assessing the level of ionising radiation exposure of occupationally exposed persons, patients and population and fails to deliver the report on these measurements to the Agency (Article 20, Paragraph 1);

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4) fails to keep the records on performed activities in radiation protection and fails to deliver the records data to the Agency within the required period (Article 28, Paragraph 1);

5) fails to report to the Agency any change in data on the fulfilment of conditions that served as the basis for issuing the licence for performing a radiation practice (Article 30, Paragraph 6);

6) fails to obtain from the Agency the certificate of registration for low-level sources and low-radiation risk (Article 32, Paragraph 1);

7) fails to provide personal dosimetry control to occupationally exposed persons or provide them with personal protection means and their proper use or fails to address them to regular medical checks, training and periodical renewal of knowledge (Article 34);

8) fails to retain in its temporary store and in the required manner the radioactive waste as a result of performing a radiation practice or nuclear activity or fails until the expiration of the required period to hand it over to the licensee for radioactive waste storage facility management (Article 35, Paragraph 1);

9) fails to keep the required records on sources of ionising radiation, occupationally exposed persons, patient exposure, and radioactive waste and fails to deliver to the Agency the required data on sources of ionising radiation, occupationally exposed persons and radioactive waste (Article 36, Paragraphs 1 and 2);

10) fails to put in place and implement the quality management system for radiation protection measures (Article 37, Paragraph);

11) employs a occupationally exposed person who does not have the required professional qualification or who is not skilled for the work or implementing radiation protection measures or if such person does not meet health conditions, or if for operations or tasks in production process management in a nuclear facility or for operations or tasks in the production process monitoring such legal person employs a person who does not have the required professional qualification and work experience (Article 40, Paragraphs 1, 2 and 3);

12) fails to ban the exposure of the people under Article 41 hereof to ionising radiation or fails to prevent ionising radiation exposure above the prescribed limits for population (Article 41);

13) conducts systematic x-ray screening of population without an approval from the Ministry responsible for healthcare (Article 45);

14) fails to pass or apply the instructions or other official documents pertaining to the nuclear facility operation and fails to obtain the consent from the Agency for such instructions and official documents (Article 52, Paragraphs 2 and 3);

15) fails to deliver to the Agency the timely reports under Article 53 hereof or fails at the Agency request to deliver all information on undertaken nuclear safety measures and all other activities regarding the enforcement of this Law (Article 53);

16) fails to set up the radiation protection department (Article 55);

17) fails to perform in the required manner and according to required conditions the systematic environmental examination on radionuclide presence in the vicinity of the nuclear facility (Article 56, Paragraph 1);

18) assigns to the tasks and operations in nuclear material handling the people who do not have the required special skills (Article 57, Paragraph 1);

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19) fails to put in place and implement the integrated quality management system or fails to apply the integrated quality management system measures (Article 60, Paragraphs 1 and 2);

20) fails to keep the records on radioactive waste and to timely deliver the records data to the Agency (Article 64, Paragraph 3);

21) fails to timely report to the Agency on the arrival of the shipment of one or several sources of ionising radiation, radioactive or nuclear materials (Article 67, Paragraph 5);

22) fails to provide to the inspector for radiation protection or the inspector for nuclear safety and radioactive waste management the performance of inspection control, smooth operation and looking into the documents and fails to provide such inspector with the data and materials required for performing inspection control (Article 82, Paragraph 1);

23) fails to report in the required form and within the required period to the Agency all sources of ionising radiation it owns or uses (Article 91).

For the violation under Paragraph 1 hereof, a fine may be imposed proportional to the amount of damage, non-performance or value of goods or other item subject to the violation, but up to twenty times the amount of the values.

For the violation under Paragraph 1 hereof, the responsible person of the legal person shall be also fined at the amount from RSD 25,000 to 50,000.

Article 87

The fine amounting from RSD 250,000 to 500,000 shall be imposed for a violation on an entrepreneur if they commit the acts under Article 84, Paragraph 1, Items 1), 2), 3), 4), 5), 6), 7), 8), 16) and 17) and Article 86, Paragraph 1, Items 2), 5), 6), 7), 8), 9), 10), 11), 12), 13), 21), 22) and 23) hereof.

XII. TRANSITORY AND FINAL PROVISIONS

Passing Bylaws

Article 88

The regulations for enforcing this Law shall be passed within two years as of the day of coming into force of this Law.

Until the regulations under Paragraph 1 hereof have been passed, such regulations shall apply which were passed for the enforcement of the law in force until the day of coming into force of this Law if they are not contrary to the provisions hereof.

Period for Founding the Public Company

Article 88а

The public company under Article 48а hereof shall be founded by the Government within three months as of the day of coming into force of this Law.

Resolution of Previously Filed Applications

Article 89

The applications filed until the day of coming into force of this Law shall be resolved according to the regulations in force at the time of filing such application.

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Harmonization with this Law

Article 90

Legal entities and entrepreneurs undertake to harmonize their operations with the provisions hereof within three years as of the day of coming into force of this Law.

The sources of ionising radiation under Article 2, Paragraphs 4 and 5 hereof shall be removed within five years as of the day of coming into force of this Law.

The removal costs for the sources of ionising radiation under Paragraph 2 hereof shall be borne by the legal person or entrepreneur who owns or uses them.

Reporting Sources of Ionising Radiation

Article 91

The legal entities and entrepreneurs performing a radiation practice undertake to report to the Agency in the required form all sources of ionising radiation they own or use within one year after the Agency starts its operation.

The Agency shall stipulate the form and content of the report under Paragraph 1 hereof within three months after the Agency starts its operation.

Permanent Disposal of Radioactive Waste

Article 92

The Republic of Serbia shall provide the conditions for permanent disposal of radioactive waste within ten years as of the day of coming into force of this Law.

Cessation of the Law

Article 93

On the day of coming into force of this Law, the Law on Radiation protection (“Official Gazette of the FRY”, no. 46/96 and “Official Gazette of the RS”, no. 85/05 – other law and 101/05 – other law) shall cease.

Coming into Force of the Law

Article 94

This Law shall come into force eight days following its publication in the “Official Gazette of the Republic of Serbia”.

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