Kiirgusseadus (KiS)

§ 1. Scope of application of Act

(1) This Act provides for:

1) the basic safety requirements for the protection of people and the environment against the adverse impact of ionizing radiation;

2) the rights and obligations of persons in using ionizing radiation;

3) the requirements for radiation practices;

4) the organisation of state supervision over compliance with the requirements provided for in this Act;

5) the liability for failure to comply with the requirements provided for in this Act.

(2) This Act regulates radiation practices and activities where natural radiation sources may cause a significant increase of the exposure incurred by workers or members of the public, and intervention in the case of accidental and existing exposure.

(3) This Act does not regulate exposures to radon in dwellings, exposure caused by cosmic radiation at ground level or overground exposure to radionuclides present in the undisturbed earth's crust untouched by human activity.

§ 2. Application of Administrative Procedure Act and General Part of the Environmental Code Act

(1) The Administrative Procedure Act shall apply to the administrative procedure provided for in this Act, taking account of the specifications provided for in this Act.

(2) Chapter 5 of the General Part of the Environmental Code Act applies the proceedings of radiation practice licences issued for radiation practices and of registration of radiation practices provided in this Act, taking account of the special rules provided in this Act.

§ 3. Radiation safety

Radiation safety is the protection of people and the environment against the adverse impact of ionizing radiation.

§ 4. Radiation practices

(1) Radiation practices are any activities which increase or may increase the exposure of people to radiation emanating from artificial or natural sources of radiation.

(2) Radiation practices inter alia include:

1) production, processing, use, possession, holding, storage, transportation, including import and export, and intermediate storage or final disposal of radioactive substances;

2) use of any electrical equipment emitting ionizing radiation and operating at a potential difference of more than 5 kilovolts;

3) operation of nuclear facilities.

(3) For the purposes of this Act, processing means chemical or physical operations on radioactive material including the mining, conversion, enrichment of fissile or fertile nuclear material and the reprocessing of spent fuel.

(4) Radioactive material means material incorporating radioactive substances.

§ 4¹. Radiation practitioner

For the purposes of this Act, a radiological practitioner is a legal person or a self-employed person holding a radiation practice licence or a registration of radiation practices.

§ 5. Ionizing radiation

Ionising radiation is the direct or indirect transfer of energy in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or less.

§ 6. Radioactive substance, radionuclide and activity and activity concentration

(1) Radioactive substance is any substance that contains one or more radionuclides and which activity or activity concentration is important from the radiation safety point of view.

(2) Naturally occurring radioactive material (NORM) is a radioactive substance which primarily contains the naturally occurring radionuclides potassium-40, thorium-232, uranium-235 or uranium-238 or the radionuclides which belong to their decay chain and which activity or activity concentration is important from the radiation safety point of view.

(3) Radionuclide is an atom with a nucleus that undergoes radioactive decay and which is characterized by a specific atomic mass and atomic number.

(4) Activity (A) is the activity per quantity of a radionuclide in a specific energy state at a given time: A = dN / dt, where dN is the expectation value of the number of spontaneous nuclear transformations from that energy state in the time interval dt.

(5) Activity concentration is the activity of a radionuclide uniformly distributed in the substance per unit mass, per unit area or per unit volume.

§ 7. Radiation source

(1) Radiation source is an apparatus, radioactive substance or installation capable of emitting ionizing radiation or radioactive substances.

(1¹) Electric radiation generator means a device capable of generating ionising radiation, such as X-rays, neutrons, electrons or other charged particles

(1²) Unsealed radiation source is a radiation source containing a radioactive substance that, when used for its intended purpose, is not permanently sealed in a capsule or does not form part of a solid substance.

(2) Sealed source is a source which structure prevents any discharge of radioactive substances into the environment under proper use.

(2¹) Source container means an assembly of components intended to guarantee the containment of a sealed source, where it is not an integral part of the source but is meant for shielding the source during its transport and handling.

(3) High-activity source is a sealed source which contains a radionuclide which known activity during the manufacture or the first placing on the market is equal to or exceeds the established activity level.

(4) The minister in charge of the policy sector shall establish by a regulation the levels of radionuclide activities at or above which value a radiation source is classified as a high-activity source.

(5) Disused source is a radiation source which is no longer used or no longer intended to be used for the purposes which comply with the radiation practice licence or radiation practice registration.

(5¹) Orphan source means a radiation source which is neither exempted from under regulatory control on the basis of § 8 of this Act or under regulatory control because it has never been under such control or because it has been abandoned, lost, misplaced, stolen or transferred without proper authorisation.

(6) Radiation source category is a risk level which is determined on the basis of the assessment of the potential exposure of a radiation source taking into account, where appropriate, the physical and chemical properties of the radioactive substance and the activity of the radionuclides contained in it.

(7) Recovery of a radiation source denotes all the activities which are necessary to render safe a dangerous radiation source upon termination of the radiation practices connected to the source.

§ 8. Exemption level and clearance level

(1) Exemption level is the value of activity or activity concentration of radioactive substances at the value equal to which or below which no radiation practice licence or radiation practice registration is required.

(2) Clearance level is the value of activity or activity concentration at or below which the radioactive substances or materials containing radioactive substances generated in the course of any radiation practice subject to the requirement of a radiation practice licence or radiation practice registration may be exempt, pursuant to the procedure established on the basis of subsection 3 of § 62 of this Act, from compliance with the requirements of this Act.

(3) The requirements for exemptions and exemption applications shall be established by a regulation of the minister in charge of the policy sector.

§ 9. Members of public

For the purposes of this Act, a member of the public is any natural person, except for people exposed to occupational or medical exposure.

§ 10. Exposed workers

An exposed worker is a person in an employment or service relationship with a radiation practitioner, including any outside worker, who is exposed at work in the course of radiation practices governed by this Act and whose radiation dose exceeds or may exceed the dose limits established for members of the public on the basis of subsection 6 of § 50 of this Act.

§ 11. Exposures

Exposure is irradiation of people with ionising radiation.

§ 12. Emergency and existing exposure situations and radiological emergencies

(1) Emergency exposure situation is an exposure situation developed as a result of a nuclear accident or radiological accident, an exposure situation incurred as a result of a crime or other unexpected event which controlling requires the implementation of urgent protective measures for the protection of human life and health, property and the environment.

(2) Existing exposure situation denotes natural exposures higher than the normal natural radiation or radiation resulting from past radiation practices or emergency exposure situations or other unusual exposure situations which do not require or no longer require implementation of urgent protective measures.

(3) Radiological emergency is an emergency exposure situation which involves or may involve exceeding of the intervention levels established on the basis of subsection 3 of § 105 of this Act.

§ 13. Emergency exposure and emergency worker

(1) Emergency exposure is an exposure of people incurred as a result of an emergency exposure situation which does not include emergency occupational exposure.

(2) For the purpose of this Act, emergency worker means any person who has a defined role in an emergency exposure situation and who might be exposed to radiation while executing the specified task.

§ 14. Public exposure, occupational exposure and emergency occupational exposures

(1) Public exposure is the exposure of members of the public, excluding any occupational or medical exposure.

(2) Occupational exposure is an exposure which an exposed worker incurs or may incur from radiation practices which are carried out on the basis of a radiation practice licence or radiation practice registration.

(3) Emergency occupational exposure means exposure received in an emergency exposure situation by an emergency worker.

§ 15. Planned exposure situation, normal exposure and potential exposure

(1) Planned exposure situation means an exposure situation that arises from the planned operation of a radiation source or from a human activity which alters exposure pathways so as to cause the exposure or potential exposure of people or the environment. Planned exposure situation may include both normal exposure and potential exposure.

(2) Normal exposure means exposure expected to occur under the normal operating conditions of a facility or activity, including maintenance, inspection and decommissioning, which includes minor incidents that can be kept under control.

(3) Potential exposure is exposure which is not expected to be delivered with certainty but the probability of which can be assessed in advance.

§ 16. Medical exposure

Medical exposure means exposure:

1) of individuals during diagnosis, treatment or early detection of a disease;

2) of helpers of individuals being exposed who assist patients incurring medical exposure in the course of any procedure relating to medical exposure if such assisting is not part of their professional activities and where such people are aware of the risks associated with exposure;

3) of individuals who have voluntarily agreed to participate in scientific research or clinical research.

§ 16¹. Potential exposure

Non-medical exposure means exposure of individuals during intended use of ionizing radiation for imaging purposes where the objective is not the diagnosis, treatment or early detection of a disease.

§ 17. Natural exposures

Natural exposures are exposures caused by natural ionising radiation sources of terrestrial or cosmic origin.

§ 18. Nuclear material

Nuclear material is plutonium, except for mixtures of plutonium isotopes with Pu-238 content greater than 80 per cent, uranium-233, uranium-235 and uranium enriched in the isotopes 233 or 235; uranium containing the mixture of isotopes as occurring in nature other than in the form of ore or ore-residue, thorium, and any material containing one or more of the above specified nuclear materials.

§ 19. Nuclear safety

Nuclear safety is the situation which is achieved by means of the activities related to radiation safety and which aim is to achieve proper operating conditions through compliance with the established operating requirements and to avert emergency exposures and mitigate the consequences of emergency exposures as a result of which the protection of workers and the other population against the dangers arising from ionizing radiation of nuclear facilities is improved.

§ 20. Nuclear facility, nuclear fuel cycle and spent fuel

(1) Nuclear facility is an enrichment plant, nuclear fuel manufacturing plant, nuclear power plant, processing plant and research reactor and facilities directly connected with these and located in the same place which is used for storing spent fuel, and facilities for storing radioactive waste which is directly connected to the above listed nuclear facilities and is located in the same place.

(2) Nuclear fuel cycle includes all operations related to the production of nuclear energy, including mining and processing of ores which contain nuclear materials, isotopic enrichment, manufacture, use and storage of nuclear fuel, reprocessing of spent fuel and processing, intermediate storage or final disposal of produced waste.

(3) Spent fuel is nuclear fuel irradiated in a reactor core and permanently removed therefrom which can be treated as usable resources if it is intended for reprocessing, or as radioactive waste if it is subject to final disposal.

§ 21. Justification of radiation practices

(1) Planned radiation practices have to be justified by proving that they are the best based on their economic, social or other benefits in relation to the potential health detriment they may cause.

(1¹) For the purposes of this Act, health detriment means reduction in length and quality of life occurring in people following exposure, including detriments arising from tissue reactions, cancer and major genetic disorders.

(2) The justification of radiation practices shall be reviewed whenever new and important evidence about the efficacy or consequences of existing types of radiation practices is acquired.

§ 22. Optimization of exposure

Any exposure shall be kept as low as reasonably achievable, taking into account the economic and social factors.

§ 23. Limitation of exposure doses

(1) The sum of exposure doses shall not exceed the limits established on the basis of subsection 6 of § 50 of this Act. This requirement does not apply to medical exposures and emergency occupational exposes.

(2) Effective dose is the sum of the equivalent doses multiplied by tissue weighting factors which characterise differences in sensitivities to radiation of human tissues and organs.

(3) Equivalent dose is the absorbed dose in human tissue or organ multiplied by radiation weighting factor of effective radiation.

(4) For the purposes of this Act, absorbed dose is the average dose for human tissue or organ of the energy of ionising radiation absorbed per unit mass of substance.

(5) Radiation weighting factor is a dimensionless factor which takes into account the different ability of types of radiation to cause health detriment.

(6) Tissue weighting factor is a dimensionless factor which takes account of the different sensitivity which organs and tissues have to radiation.

(7) Dose rate is an increase of dose per unit time.

(8) Dose limits are maximum values of exposure caused to exposed workers and the members of the public which are applied to the sum of doses incurred from external exposures and intake of radionuclides during a limited period of time. The dose incurred by intake of radionuclides during a year is totalled in 50 years (for children, up to 70 years).

(8¹) Dose constraint means a constraint set as a prospective upper bound of individual doses, used to define the range of options considered in the optimisation for a given radiation source in a planned exposure practices.

(9) Intake is the entry of radionuclides into the body via the respiratory tract, gastro-intestinal tract or skin.

§ 24. Addition of radioactive substances and import and export of foodstuffs and consumer products and animal feeds with such additions

(1) Deliberate addition of radioactive substances in the foodstuffs, animal feeds, toys, jewellery and cosmetic products, during their manufacture and the import and export of such goods which contain radioactive substances is prohibited.

(2) Activation of materials used in toys and jewellery upon manufacture thereof and import and export of products and materials which contain such radioactive substances is prohibited.

(3) Activation means a process through which a stable nuclide is transformed into a radionuclide by irradiating with particles or high-energy photons the material in which it is contained.

(4) For the purposes of this Act, consumer product means a product into which one or more radionuclides have deliberately been incorporated or produced by activation, or which generates ionising radiation, and which can be sold or made available to members of the public without surveillance or regulatory control after sale.

(5) The Environmental Board shall inform the competent authorities of the Member States of the European Union of authorisation or prohibition of manufacture and importation of the consumer products specified in subsection 4 of this section.

§ 24¹. Liability of radiation practitioner

A radiation practitioner is liable for fulfilling the obligations provided in this Act and in the conditions of the radiation practice licence or radiation practice registration to ensure radiation safety and protection of workers in all situations related to a radiation source in their possession or their radiation practices.

§ 25. Organisation of radiation safety activities

Radiation safety activities are organized by the Ministry of Climate within its area of competence through the Environmental Board by engaging other appropriate agencies for this purpose and by taking inter alia into account field-specific operational experience, results of decision making procedures, development of relevant technology and scientific researches.

§ 26. National development plan for radiation safety

(1) The national planning of implementation of the objective provided for in § 1 and the principles provided in §§ 8–13 of the General Part of the Environmental Code Act and the principles of radiation safety provided for in this Act is pursued through the national development plan for radiation safety (hereinafter development plan) drawn up by the Ministry of Climate.

(2) The development plan analyses the situation of radiation safety in the country, determines the measures for improvement of radiation safety and gives an assessment on how the development plan promotes pursuing of the objectives and principles provided for in subsection 1 of this section.

(3) Development plans are approved by a directive of the minister in charge of the policy sector.

§ 27. Content of development plan

The areas discussed in the development plan include in particular ensuring radiation protection and nuclear safety, radioactive waste management, responding to accidental and existing exposure situations, increasing radiation awareness and issues concerning natural and medical exposures.

§ 28. Action plans for implementation of development plans

(1) In order to implement development plans or achieve the objectives of organization and improvement of radiation safety, the Ministry of Climate may prepare development plans for the areas specified in § 27 of this Act.

(2) Development plans shall be approved by a directive of the minister in charge of the policy sector.

§ 29. State radiation safety audit and topical peer review

(1) State radiation safety audit is an audit organised for the purpose of increasing radiation safety in the course of which the legal and organisational arrangements of state radiation safety and the agencies ensuring radiation and nuclear safety are assessed. Internationally recognized radiation experts shall be involved in the audit.

(1¹) A topical peer review is a national assessment carried out for the purposes of ensuring nuclear safety and the report prepared on it shall be submitted for assessment to other Member States of the European Union and the European Commission. The results of topical peer reviews shall be taken into consideration in preparation of the development plan and action plans specified in §§ 26 and 28 of this Act.

(2) State radiation safety audits shall be organised by the Ministry of Climate at least every ten years and immediately when an emergency exposure situation occurs at a nuclear facility.

(3) Thematic peer reviews are organised by the Ministry of Climate in accordance with the guidelines of the European Commission.

§ 30. Radiation safety guidelines and information materials and communication of information

(1) The Environmental Board and the Health Board shall promote, within their area of competence, radiation awareness, use of good practice and compliance with radiation safety principles, and issue radiation and nuclear safety guidelines and information materials which are published on the website of the Environmental Board and the Health Board.

(2) The Environmental Board and the Health Board shall disseminate to relevant parties, including manufacturers and suppliers of radiation sources and, where appropriate, international organisations, protection and safety information based on experience learned from identification of radiation practices, inspections and from reported incidents and accidents and related findings.

§ 31. Paid services to ensure radiation safety

(1) The Environmental Board may provide paid radiation safety services related to its main activities unless this hinders the performance of its functions arising from the statutes.

(2) Minimum and maximum rates for paid services by types of services are the following:

1) measurement of radiation level in one metering point – 25 to 75 euros;

2) preparation of a radiation safety assessment for radiation practices and calculation of the radiation shielding – one hour EUR 10–30;

3) thermoluminescence dosimetry for personal dose determination - EUR 13-39;

4) laboratory testing of radioactivity level of substances – 50 to 320 euros;

5) measurement of radon concentration in indoor air – 45 to 135 euros.

(3) Taking into consideration the provisions of subsection 2 of this section, the minister in charge of the policy sector shall establish by a regulation a detailed list of paid services and the rates of fees on the basis of the labour, material, equipment and overhead costs required for the provision of the service.

§ 32. General obligations of the radiation practitioner

(1) A radiation practitioner is required to:

1) comply with the radiation safety principles;

2) ensure radiation safety and physical protection of the radiation sources in the holder’s possession and to verify at least annually that the radiation source or the equipment containing thereof is present at the place of use or storage and in apparently good condition;

3) ensure the safety of the radiation source by correct installation and placement of the radiation source in the premises, mark the radiation source and the premises and use protective equipment;

4) keep records of every radiation source and radioactive waste for which the holder is responsible, the location and transfer thereof, take annual inventories of radiation sources and radioactive waste;

5) prepare the rules necessary for carrying out radiation works and instructing exposed workers and ensure updating of these rules upon commissioning of new technology or equipment;

6) organise medical examination of exposed workers;

7) ensure regular control and calibration of measuring instruments used and be responsible for their fitness for use and professional use thereof;

8) at the request of competent authorities, prove the legality of possession of radioactive substances or radiation apparatuses containing radioactive substances;

9) ascertain that the recipient has an appropriate radiation practice licence or radiation practice registration before transfer of a radiation source;

10) render a radiation source harmless after its use is terminated pursuant to the plan for rendering the radiation source harmless;

11) ensure that radioactive waste is managed in such a manner that the estimated harmful effect on future generations will not exceed the effect permitted by this Act or legislation established on the basis thereof;

12) cover all expenses incurred in radioactive waste management;

13) ensure that the activity and quantities of generated radioactive waste and emissions are as low as possible;

14) alleviate the consequences of emergency exposure situations;

15) immediately inform the Environmental Board and the Emergency Centre by calling the emergency number 112 of any loss, theft or unauthorised use of radiation sources and of any incidents or accidents which took place during radiation practices and resulted in workers or members of the public receiving an equivalent or effective dose in excess of the dose limits established pursuant to subsection 6 of § 50 of this Act, and submit to the Environmental Board, after the incident, an analysis of the causes thereof and implementation of the remedial measures;

16) control the integrity of radiation sources after each incident if it may have damaged the radiation source and, if necessary, inform the Environmental Board of this incident and the measures implemented;

17) during procurement procedures for radiation sources, prefer manufacturers who agree to include a clause in the contract of sale regarding return of the radiation source to the producer;

18) not to offer proprietary and other benefits to workers for failure to comply with any radiation safety requirements.

(2) Upon high risk radiation practices, a holder of a radiation practice licence is obliged to:

1) prepare a response plan to emergency exposure situations;

2) ensure that a recognized radiation expert has approved the design documentation of the facilities of radiation practices and the commissioning of new radiation sources.

(3) A holder of a radiation practice licence must ensure that the holder has sufficient funds to cover the expenses of recovering radioactive substances, radiation sources containing radioactive substances and radioactive waste.

(4) The minister in charge of the policy sector shall establish by a regulation the requirements for premises where radiation sources are located, for marking the premises and radiation sources, and radionuclide activity levels.

§ 33. Obligations of persons in possession of nuclear material

(1) A person in possession of nuclear materials is required to keep records of the nuclear material used from the time of acquisition until the time of storage thereof as waste, recovery of the material or change of ownership, and to appoint a person responsible for keeping records of nuclear materials.

(2) A person in possession of nuclear materials shall immediately inform the Environmental Board of changes in the quantity of nuclear materials.

(3) Standard data formats which characterise radiation sources are used to keep lists of nuclear materials.

(4) The minister in charge of the policy sector shall establish by a regulation the lists of the data which characterise radiation sources .

§ 34. Radiation practice risk level

(1) A distinction is made between the following types of radiation practices:

1) very low-risk radiation practices;

2) low-risk radiation practices;

3) moderate-risk radiation practices;

4) high-risk radiation practices.

(2) The risk level of radiation practices is determined taking into account the following risk factors related to the radiation source and radiation practices:

1) radiation safety and physical protection risks;

2) infrastructure and resources;

3) safety culture;

4) the potential estimated doses to radiation practitioners and members of the public under normal working conditions and in emergency and continuous exposure situations;

5) other relevant factors.

(3) The procedure for determining the risk level of an radiation practices is established by the minister in charge of the policy sector by a regulation, taking into account the provisions of subsection 2 of this section.

(4) The Environmental Board determines the risk level in the procedure for granting a radiation practice licence and radiation practice registration in accordance with the procedure established pursuant to subsection 3 of this section.

(5) The following radiation practices are always regarded as high risk radiation practices:

1) radiation practices involving a high-activity radiation source;

2) operation of a nuclear facilities;

3) exploitation, closure and decommissioning of any nuclear fuel cycle facility;

4) intermediate storage and final disposal of radioactive waste.

(6) Radiation source categories of radiation sources and requirements for physical protection of radiation sources depending on the category of radiation source are established by a regulation of the minister in charge of the policy sector.

§ 35. Radiation safety quality management system

(1) A radiation practitioner is required to develop and implement a quality management system for radiation safety and other activities related thereto which ensures compliance with the requirements provided in this Act and legislation established on the basis of this Act and the requirements determined in the radiation practice licence or radiation practice registration.

(2) Radiation safety quality management systems cover:

1) planned and systematic activities which objective is to ensure radiation safety;

2) analysis of duties, and skills required for and requirements for use of radiation sources which include, in particular, description of radiation practice, guidelines for radiation practice, workers' training procedure;

3) requirements for procurement, use and disuse of materials and equipment;

4) description of radiation safety procedures implemented during radiation practices;

5) procedure for controlling the functioning and improvement of the radiation safety quality management system.

(3) In addition to the provisions of subsection 2 of this section, a nuclear facility radiation safety quality management system covers:

1) description of systematic activities conducted for the purpose of ensuring nuclear safety;

2) analysis of duties and requirements for competence required to operate nuclear facilities;

3) description of the control system for compliance with nuclear safety requirements;

4) plans for training and instructing the workers.

§ 37. Inventory report of radiation sources and radioactive waste

(1) A radiation practitioner is required to submit a report to the Environmental Board on the inventory provided in clause 4 of subsection 1 of § 32 of this Act by 1 March of the year following the accounting year.

(2) Unless the requirements of the radiation practice licence or radiation practice registration specify otherwise, the accounting documents must contain data on the radiation source which are required when applying for a radiation practice licence or radiation practice registration.

(3) The reports specified in subsection 1 of this section shall be submitted via the Information System for Environmental Decisions.

§ 38. Obligations of holders of radiation practice licences in case of high-activity radiation sources

In addition to the general obligations provided for in § 32 of this Act, a holder of a radiation practice licence is required to do the following in the case of radiation practices related to high-activity radiation sources:

1) ensure that written information is included with the radiation source which proves that the radiation source is identified by a unique number and includes photos of the source, container, transport packaging of the source and, if necessary, devices and equipment;

2) ensure that proper tests have been performed with the frequency determined by the issuer of the licence in order to check and maintain the integrity of the radiation source;

3) return every disused source immediately after discontinuing the use thereof to the manufacturer, transfer it to another holder of a radiation practice licence or to a radioactive waste management facility;

4) enter into a contract with manufacturer upon purchase of a radiation source according to which the manufacturer undertakes to take back the radiation source at the latest 15 years after the importation of the source if the activity of the source exceeds 10 MBq ten years after the importation thereof into the county.

§ 39. Obligations of holders of radiation practice licences related to radioactive waste

In addition to the general obligations provided for in § 32 of this Act, a holder of a radiation practice licence is required to do the following in the case of radiation practices related to radioactive waste management:

1) ensure safety of the radioactive waste storage premises during the entire of use thereof;

2) organise the management of radioactive waste if this is necessary for modifying the properties of the radioactive waste prior to the release thereof into the environment, or the conditioning and intermediate storage and final disposal thereof;

3) take into account other risks and various stages of generating radioactive waste and interaction of radioactive waste when planning activities and in the course of activities;

4) transfer radioactive waste to a final disposal facility for radioactive waste within five years from the generation thereof at the latest.

§ 40. Obligations of holders of radiation practice licences upon operation of nuclear facilities

In addition to the general obligations provided for in § 32 of this Act, a holder of a radiation practice licence is required to do the following in the case of operation of nuclear facilities:

1) ensure implementation of nuclear safety measures and compliance with relevant requirements;

2) ensure that the workers and subcontractors of the nuclear facility comply with the nuclear safety culture and nuclear safety quality management system implemented at the nuclear facility on the basis of their official duties;

3) assess nuclear safety at the nuclear facility at least with the same frequency as provided for in the requirements of the radiation practice licence.

§ 41. Transportation of radioactive substances and apparatuses containing radioactive substances

(1) Radioactive substances and apparatuses containing radioactive substances in which the activity or activity concentration of radionuclides exceeds the exemption level shall be transported by road, railway and air and waterway pursuant to the procedure provided for in legislation concerning hazardous loads.

(2) Transportation of radioactive substances and apparatuses containing radioactive substances over the state border shall comply with international agreement which have entered into force for the Republic of Estonia and on the basis of the legislation.

(3) Transportation of radioactive substances and apparatuses containing radioactive substances includes the operations related to transportation of radioactive substances from a point of departure to a point of destination, including loading and unloading.

§ 42. Medical radiological procedure

(1) For medical radiological procedures, the use of medical exposure must be justified and the expected benefit of the procedure for the individual or society must outweigh the individual detriment that it may cause.

(1¹) Medical radiological procedures must be performed optimally by keeping the radiation dose during the procedure as low as possible and reasonable in order to achieve the objective of the procedure.

(1²) Patients must be informed before any medical radiological procedures of any risks of ionizing radiation and the data of previous medical radiological procedures performed to the patient must have been ascertained on the basis of any available information.

(2) Medical radiological procedure is any procedure concerning medical exposure.

(2¹) Potential individual detriment due to medical exposure means any clinically observable deleterious effects in individuals or their descendants, the appearance of which is either immediate or delayed.

(4) Radiation safety requirements for medical radiological procedures shall be established by a regulation of the minister in charge of the policy sector.

§ 42¹. Use of medical exposure devices for non-medical procedures

(1) A holder of radiation practice licence shall ensure compliance, upon use of medical radiology devices for non-medical radiological procedures, with requirements equivalent to those for medical radiological procedures.

(2) Medical radiology devices are devices that emit or register ionizing radiation and are used for medical radiological procedures.

§ 43. Clinical audit of medical radiological procedures

(1) Holders of radiation practice licences shall ensure proper performance of the clinical audit of medical radiological procedures.

(2) A clinical audit of medical radiological procedures is a purposeful review of medical exposure practices for the purpose of improvement of clinical performance, safety and quality, and comparison thereof with best practice standards, as appropriate changing the relevant medical exposure practice, adapting the standards and organising training and instructing of exposed workers or other employees related to medical radiological procedures.

(2¹) Medical exposure practice means the performance of medical radiological procedures and performance of preceding and subsequent acts relating to the procedures.

(5) The requirements for clinical audits shall be established by a regulation of the minister in charge of the policy sector.

§ 44. Diagnostic reference level

(1) Diagnostic reference levels are used for optimisation of medical radiology procedures. If these are exceeded, measures for decreasing relevant patient doses have to be considered.

(2) Diagnostic reference level means a reference level of radiation doses incurred during medical radiology procedure or the activity of any radiopharmaceutical for a standard size patient.

(2¹) The Health Board shall ensure determination of diagnostic reference levels.

(3) Diagnostic reference levels and requirements for determination of diagnostic reference levels shall be established by a regulation of the minister in charge of the policy sector.

§ 45. Categories of exposed workers

Categories of exposed workers are:

1) exposed workers of category A who may incur an effective dose exceeding six millisieverts or exceeding three tenths of the equivalent dose limit for the lens of the eye, skin and extremities established on the basis of subsection 6 of § 50 of this Act;

2) exposed worker of category B who are exposed workers and who are not classified as exposed workers of category A.

§ 46. Radiation safety specialist

(1) A radiation safety specialist is a person technically competent in radiation protection matters related to the relevant practice, who may be appointed by the radiation practitioner as a radiation safety manager in the undertaking.

(1¹) Depending on the nature of the radiation practice, a radiation safety specialist may perform inter alia the following duties:

1) ensure that radiation works are performed in compliance with the requirements prescribed in the radiation work rules;

2) check the implementation of work place monitoring plans;

3) maintain records of relevant data relating to all sources of radiation;

4) regularly assess the operation of safety and warning systems;

5) check the implementation of plans for monitoring of individual doses of exposed workers;

6) check the implementation of plans for medical surveillance of exposed workers;

7) present the radiation work rules and instructions to new workers;

8) prepare work plans relating to radiation practices or participate in the preparation thereof;

9) submit reports to the management;

10) participate in prevention of any emergency exposure situation and in the arrangements for preparedness for responding to it;

11) instruct exposed workers and arrange their training;

12) co-operate with radiation experts.

(2) In the case of high risk radiation practices or where the radiation practitioner has more than ten exposed workers, designation of a radiation safety specialist is mandatory.

(3) Designation of a radiation safety specialist does not release a radiation practitioner of their responsibility to ensure radiation safety.

(4) The requirements for radiation safety training of radiation safety specialists shall be established by a regulation of the minister in charge of the policy sector.

§ 47. Age limits for radiation works

Persons under the age of 18 years shall not be designated to perform any radiation works.

§ 48. Radiation safety training and instructions of exposed workers

(1) A radiation practitioner is required to ensure that exposed workers receive radiation safety training and instructions which take into account the nature of work and the conditions at workplace.

(2) The requirements for radiation safety training of exposed workers shall be established by a regulation of the minister in charge of the policy sector.

§ 49. Medical surveillance of exposed workers

(1) When employing or classifying a category A exposed worker as a category A exposed worker, a radiation practitioner is required to ensure that the worker undergoes a medical examination before they commence work and at least once a year. Where the result of a pre-employment medical examination shows that a worker is not suitable for a particular position, they may not be classified as a category A worker or employed in that position.

(2) Where exposure exceeding established dose limits to a exposed worker is ascertained, the radiation practitioner immediately refers the exposed worker to medical examination.

(3) Medical examination of exposed workers takes place pursuant to the procedure provided for in the Occupational Health and Safety Act.

(4) Employers shall present the data of occupational exposure doses of exposed workers to occupational health doctors upon referral of exposed workers of category A to medical surveillance by means of filling these data in the form presented in Annex 2 to the regulation established on the basis of clause 8 of subsection 1 of § 13¹ of the Occupational Health and Safety Act. Occupational health doctors shall record the dose data of an exposed workers to the worker’s medical record.

(5) Occupational health service providers fill the dose data of category A workers in their medical records as long as the worker remain a worker of that category. Thereafter, the occupational health service provider shall retain it until the person in question has or would have attained the age of 75 years, but at least 30 years after termination of the work involving exposure to ionising radiation.

§ 50. Individual dose monitoring

(1) A radiation practitioner organises monitoring of individual doses incurred by exposed workers and submission of monitoring data to a dose register.

(1¹) A holder of radiation practice licence grants workers or outside workers, at their request, access to the results of their individual monitoring, including the results of measurements which may have been used in estimating these results, or to the results of the assessment of their doses made as a result of surveillance of the workplace.

(2) Individual doses of exposed workers of category A shall be continuously monitored at workplaces and verification of individual dose monitoring shall be performed at least once per month.

(3) Individual dose monitoring of exposed workers of category B must be sufficient to demonstrate that the workers are correctly classified in category B.

(4) Where an exposed worker may incur significant exposure due to intake of radionuclides, the monitoring of individual doses organised by the radiation practitioner must enable to assess or measure the individual doses incurred by intake of radionuclides.

(5) The measurements conducted during individual dose monitoring must be accredited.

(6) The limits for effective doses of exposed workers and members of the public and the limits for equivalent doses of the lens of the eye, skin and extremities shall be established by a regulation of the Government of the Republic.

§ 51. Outside worker

Outside worker means any exposed worker who is not employed by the person responsible for the supervised and controlled areas, but performs activities in those areas, including, apprentices and students.

§ 52. Ensuring radiation safety of outside workers

(1) A radiation practitioner ensures radiation safety for an outside worker which is equal to that of an exposed worker and training and instruction on radiation safety taking account of the specific nature of their work and the conditions on their workplaces.

(1¹) Before permitting an outside worker to work, a holder of radiation practice licence checks, based on the data recorded in the dose chart, that:

1) the outside worker is suitable for radiation work based on the data of the medical examination;

2) the outside worker’s anticipated occupational exposure doses of the previous and planned radiation practice does not exceed the dose limits in force;

3) the outside worker has passed radiation safety training.

(2) The data indicated in the dose card of an outside worker and the procedure for formalising dose cards and the standard format of dose cards shall be established by a regulation of the minister in charge of the policy sector.

§ 53. Control and surveillance areas

(1) Workplaces shall be divided into the following areas based on the type of premises and building in which the radiation source is located, category of the radiation source, and the radiation risk at the workplace:

1) control areas;

2) surveillance areas.

(2) Protection in control areas against ionizing radiation or prevention of spreading of radioactive contamination is ensured by establishment of appropriate rules. Access to control areas is controlled.

(3) Protection in surveillance areas against ionizing radiation is ensured through appropriate monitoring.

(4) The minister in charge of the policy sector establishes by a regulation the bases for formation of control and surveillance areas and the obligations applicable there.

§ 54. Monitoring in control and surveillance areas

(1) A radiation practitioner ensures monitoring of any control and surveillance area.

(2) Depending on the need, monitoring of controlled and supervised areas shall include:

1) monitoring of dose rates;

2) monitoring of levels of radioactive contaminants in the air or on surfaces together with determining the properties of the radioactive emissions and their physical and chemical state.

(3) A radiation practitioner registers the results of monitoring and preserves these results during the entire period of operation in the area of radiation practices.

§ 55. Additional measures to ensure radiation safety

Where any exposure to members of the public caused by radiation practices may exceed one-tenth of the dose limits for members of the public established on the basis of subsection 6 of § 50 of this Act per year, the radiation practitioner consults with a radiation expert with regard to the need to adopt possible additional measures in order to ensure radiation safety.

§ 56. Radioactive waste, NORM residues and NORM waste

(1) Radioactive waste is any substances or items which contain or are contaminated with radioactive substances and the activity concentration of which exceeds the clearance levels established on the basis of subsection 3 of § 62 of this Act and which are not intended to be used in the future.

(2) The classification of radioactive waste and the detailed requirements for registration, management and transfer of radioactive waste shall be established by a regulation of the minister in charge of the policy sector.

(3) NORM residues are substances which contain naturally occurring radioactive materials resulting from any activities or which are contaminated therewith and the activity or activity concentration of which exceeds the established clearance levels and which are intended to be used in the future.

(4) NORM waste is radioactive waste which contains naturally occurring radioactive materials, including NORM residues, which are not intended to be used in the future.

(5) The procedure for management of NORM residues, including storage, dispersion and release thereof, and intermediate storage or final disposal of NORM waste shall be determined by a radiation practice licence.

§ 57. Radioactive emissions

(1) Radioactive emissions are radioactive substances which are emitted in the course of radiation practices and released into the environment with the aim of their dispersion.

(2) The detailed requirements for management of emissions generated in the course of radiation practices shall be established by a radiation practice licence.

§ 58. Radioactive waste management

(1) Radioactive waste management includes pre-processing, processing, conditioning of radioactive waste, transportation thereof at the management facility, storage, decommissioning, intermediate storage or final disposal and other activities related to radioactive waste.

(2) Conditioning of radioactive waste includes all operations related to the production of packaging for radioactive waste which purpose is to make the packaging easy to handle.

(3) Packaging of radioactive waste must comply with the requirements for management, including conditioning, and it contains the form of waste and any containers and internal barriers.

(4) Decommissioning includes all the activities and measures which are implemented for partial of complete termination of the operation of any facility which poses a radiation risk to individuals and which includes deactivation and full or partial dismantling of the facility.

§ 59. Radioactive waste storage premises

Radioactive waste storage premises are premises for collection, storage, pre-processing or packaging of radioactive waste at the producer of radioactive waste which complies with the requirements established by a radiation practice licence.

§ 60. Radioactive waste management facility

Radioactive waste management facility is a facility intended for receipt of radioactive waste from the producers thereof, collection, processing and conditioning and intermediate storage or final disposal of radioactive waste.

§ 61. Radioactive waste storage facility

(1) Radioactive waste storage facility is a facility intended specifically for intermediate storage or final disposal of radioactive waste.

(2) Intermediate storage is placing of radioactive waste in a facility, which is technically equipped for this purpose, in order to ensure the isolation thereof with the intention to remove radioactive waste from the facility in the future for release, processing and conditioning or final disposal.

(3) Final disposal is placing of radioactive waste in storage facilities which conform to certain requirements or facilities which are prepared for such purposes without the intent to retrieve it later.

(3¹) The radioactive waste generated in Estonia shall be finally disposed in Estonia, except in the case at the time of export of waste for the purpose of final disposal an agreement has entered into force between Estonia and any other member state of the European Union or any third country for use of facilities intended for final disposal in that country.

(4) The intermediate storage and final disposal of radioactive waste shall be organised by the Ministry of Climate.

(5) The obligation specified in subsection 4 of this section may be transferred to a company in state ownership which principal activity is radioactive waste management and with which the minister in charge of the policy sector has entered into an administrative contract for this purpose in accordance with the rules provided in the Administrative Cooperation Act. Sections 6 and 14 of the Administrative Cooperation Act do not apply to entry into such administrative contract.

(6) The Ministry of Climate ensures the financial resources required for intermediate storage and final disposal of radioactive waste and implementation of the national radioactive waste action plan approved on the basis of § 28 of this Act.

§ 61¹. Dilution of radioactive material

(1) Intentional dilution of radioactive materials for the purpose of exemption from compliance with the requirements of the Radiation Act is not permitted.

(2) The Environmental Board may issue a radiation practice licence for dilution of radioactive materials using non-radioactive materials for the purpose of recovery or recycling, provided exemption is the best solution based on a radiation safety assessment taking into consideration the economic, social and environmental factors.

§ 62. Exemption from radiation safety requirements

(1) The Environmental Board may decide that the requirements of this Act shall not apply to radioactive substances generated during radiation practices and the holder thereof if the substance has so low activity or activity concentration that the processing and storing thereof as radioactive waste is not necessary for radiation safety.

(2) The Environmental Board may adopt the decision provided for in subsection 1 of this section on the basis of a reasoned application of a holder of radioactive substances.

(3) The clearance levels for radioactive substances and items contaminated with radioactive substances resulting from radiation practices and the requirements for their clearance, recycling and reuse shall be established by a regulation of the minister in charge of the policy sector.

§ 63. Cleared waste management

The Waste Act shall apply to management of the waste cleared pursuant to the requirements established on the basis of subsection 3 of § 62 of this Act.

§ 64. Delivery of radioactive waste to radioactive waste storage facilities

(1) In the cases where radioactive waste cannot be released into the environment with the aim of dispersion thereof or, within a period of five years after production thereof, cannot be exempted from the requirements of this Act or legislation established on the basis thereof, the person who produced the radioactive waste shall deliver the waste to radioactive waste storage facilities.

(2) Radioactive waste delivered to storage facilities must be packaged according to the compliance criteria of packaging.

(3) Compliance criteria of packaging are indicators or identifiers which characterise the suitability of packaging of radioactive waste for management.

(4) The compliance criteria for packaging shall be established by a regulation of the minister in charge of the policy sector.

§ 65. Taking possession of radioactive substances, equipment containing thereof and radioactive waste by state

(1) Where holding of radioactive substances, equipment containing thereof and radioactive waste is illegal or there is reasonable doubt in connection therewith that an emergency exposure situation may occur, or in the case of radiation sources without an owner or radioactive waste without an owner, the state shall take possession of these.

(1¹) Seizure of any radioactive substances specified in subsection 1 of this section, equipment containing thereof and radioactive waste by the state shall be decided by the Environmental Board.

(2) The sources of radiation and radioactive waste specified in subsection 1 of this section which possession is taken by the state shall be delivered to the radioactive waste manager appointed on the basis of subsection 5 of § 107 of this Act.

(3) In the case of illegal possession of radioactive substances, equipment containing thereof and radioactive waste or if an emergency exposure situation may occur in connection therewith, the owner shall cover the costs related to taking the possession thereof by the state and management thereof.

(4) The state shall cover the costs related to taking the possession and management of sources of radiation without an owner and radioactive waste without an owner.

§ 66. Closure of radioactive waste storage facilities

(1) A holder of a radiation practice licence shall collect and analyse data on the use of radioactive waste storage facilities and send such information to the Environmental Board for preservation.

(2) The Environmental Board may order a holder of a radiation practice licence to submit a new application for a radiation practice licence for closure of storage facilities on the basis of the information provided in subsection 1.

(2¹) Closure of a disposal facility means completion of all operations after the emplacement or spent nuclear fuel or radioactive waste in a facility intended for final disposal, including the final engineering or other work required to achieve a conditional that will be safe in the long term.

(3) Requirements for closing of storage facilities shall be established by a radiation practice licence.

§ 67. Safety of radioactive waste storage facilities after closure thereof

After closure of radioactive waste storage facilities, the Environmental Board shall:

1) preserve the documents concerning the location and design of the radioactive waste storage facilities and the inventory of radioactive waste for an indefinite time;

2) organise radiation monitoring and control the restriction of access, if necessary;

3) organise intervention if, based on monitoring results or upon inspection, release of radioactive substances into the environment is established.

§ 68. Radiation practice licence and radiation practice registration

(1) A radiation practice licence is required in the case of low, moderate and high risk radiation practices for:

1) operation, shutdown and decommissioning of any nuclear fuel cycle facility;

2) production, use, storage and transportation, including import and export of radioactive substances and products containing radioactive substances;

3) use and storage of electrical radiation apparatuses;

4) management and transportation of radioactive waste;

5) practices related to increased natural exposure where radiation caused by naturally occurring radionuclides is relevant from the point of view of radiation safety;

6) installation, repair and maintenance of a radiation source.

(2) In the case of a very low risk practice, a radiation practice registration must be applied for.

(3) The list of very low risk radiation practices is established by the minister in charge of the policy sector by a regulation.

(4) No radiation practice licence or radiation practice registration is required for:

1) practices with a radioactive radiation source where the activity or activity concentration of the radionuclides used is less than or equal to the exemption level;

2) for the storage, operation, installation, repair and maintenance of electrical radiating generator operating at a potential difference of up to 30 kilovolts, where the dose rate during operation of the generator does not exceed one microsievert per hour at a distance of 0.1 metre from the surface of the generator.

(4¹) It is prohibited to commence or carry out of radiation practices in radiation works requiring a radiation practice licence or radiation practice registration without a radiation practice licence or radiation practice registration.

(5) The bases for deriving exemption levels for radionuclides and exemption levels below or equal to which a radiation practice licence or radiation practice registration is not be required are established by the minister in charge of the policy sector by a regulation.

§ 69. Issuer of radiation practice licence and radiation practice registration

A radiation practice licence and radiation practice registration are issued by the Environmental Board (hereinafter issuer of licences or issuer of registrations).

§ 69¹. Application for registration of radiation practices

(1) The following data are submitted in an application for radiation practice registration:

1) the applicant's general data or name, registry code and contact details;

2) general data of a contact person;

3) the purpose, area and location of radiation practices;

4) radiation safety assessment;

5) data characterising the radiation source;

6) general data of exposed workers;

7) general data of a radiation safety specialist.

(2) Detailed requirements for an application for radiation practice registration and a more detailed data composition of the application are established by the minister in charge of the policy sector by a regulation.

(3) An application for radiation practice registration is submitted to the issuer of the registration via the environmental decisions information system, and the application is confirmed by a digital signature.

§ 70. Applications for radiation practice licences

(1) In addition to the provisions of subsection 1 of § 42 of the General Part of the Environmental Code Act, applications for radiation practice licences shall include:

1) data which characterise the radiation source and technology used and the equipment;

2) data on radioactive waste or emissions generated during radiation practices, the management thereof and waste packaging compliance criteria and radioactive waste storage premises;

3) recovery plan of radiation source after the termination of use of the radiation source;

4) upon application for a licence for management, intermediate storage and final disposal of radioactive waste, data on the management or methods of final closure of storage facilities;

5) radiation safety assessment, which gives an overview of the aspects of radiation practices which are related to the protections of people and safety of radiation sources, including of the protective and safety measures used, and of the potentially assessed doses of exposed workers and members of the public both under normal working conditions and in the cases of accidental and existing exposure situations, to which data on measures adopted to ensure radiation safety are appended;

5¹) in the case of moderate and high risk radiation practices, restrictions on annual equivalent or effective doses of exposed workers and effective doses of members of the public upon proposed radiation practices under normal working conditions;

6) emergency response plan to emergency exposure in the case of radiation practices involving high risk which is based on the assessment of potential exposures;

7) data on radioactive waste, equipment containing thereof and financial collaterals required for recovery of radioactive waste;

8) description of the radiation safety quality management system;

9) data on exposed workers and their professional training;

10) radiation work rules, which must contain activities for the use of a radiation source, discontinuation of the use thereof and activities related thereto depending on the specific character of the radiation work;

11) plan for radiation monitoring and data on the equipment used for radiation monitoring.

(2) Documents and data provided for in subsection 3 of § 42 of the General Part of the Environmental Code Act shall be appended to applications for radiation practice licences.

(3) If a radiation practice licence is applied for importation of radioactive substances into the Republic of Estonia from a country which is not a member state of the European Union, or for exportation from Estonia to a country which is not a member state of the European Union, the applicant for the licence shall submit the data provided for in clauses 1, 2, 5 and 6 of subsection 1 of § 42 of the General Part of the Environmental Code Act and the data characterising the radioactive substance.

(3¹) An application for a radiation practice licence together with the annexes thereto shall be submitted to the issuer of licences through the Information System for Environmental Decisions and the application shall be certified by digital signature.

(4) The minister in charge of the policy sector shall establish detailed requirements for applications for radiation practice licences and the data composition of applications by a regulation.

§ 70¹. Recognition of Contracting State’s radiation practice licence

Where an undertaking is registered in another Contracting Party to the European Economic Area and a radiation practice licence or any other document which proves their right to carry our radiation practices (hereinafter Contracting Party’s practice licence) has been issued to the undertaking there, then in order to provide services in Estonia, the undertaking submits to the Environmental Board an application for recognition of this practice licence in which the following information and documents are submitted depending on the specific character of radiation practices:

1) name, registry code and contact details of the applicant;

2) description of the proposed radiation practice;

3) copy of a radiation practice licence issued by a competent authority in the country of location which is legalized or authenticated by a certificate (Apostille), unless otherwise provided for in any international agreement;

4) translation of the radiation practice licence into Estonian made by a sworn translator or notarized;

5) extract from a registration card of the commercial register of the country of location;

6) location of the radiation practice and the time period thereof in Estonia;

7) contact details of the representative of the customer in Estonia;

8) information of radiation workers, their professional training and individual dose monitoring;

9) other information which is required in order to assess radiation safety.

§ 70². Term and validity of deciding on recognition

(1) The Environmental Board shall make a decision on recognition or refusal to recognize within 30 days after receipt of a proper application.

(2) A recognition is granted for the term of up to three years.

§ 70³. Refusal to recognize and revocation of recognition

(1) The Environmental Board refuses to recognize a Contracting Party’s practice licence where:

1) recognition is applied for any practices for which no Contracting Party’s practice licence has been issued in the country of location of the applicant;

2) recognition is applied for the time when the Contracting Party’s practice license issued in the country of location of the applicant is not valid;

3) the applicant for recognition does not have radiation workers with required professional qualifications or the monitoring of their individual doses is not ensured;

4) the location applied for the radiation practice or any other terms and conditions do not enable compliance with the radiation safety requirements.

(2) The Environmental Board shall revoke a recognition if:

1) it appears that the undertaking that has been granted the recognition has knowingly submitted false information in the application for recognition or falsified documents;

2) the circumstances listed in clauses 2 and 3 of subsection 3 of § 77 of this Act become evident.

§ 70⁴. Information subject to entry in recognition decision

The recognition decision shall include:

1) the name and registry code of the undertaking that received the recognition;

2) the address and contact details of the undertaking that received the recognition and its contact person;

3) the name of the radiation practice;

4) the location of the radiation practice;

5) the term of validity of the recognition;

6) the data on radiation workers;

7) the radiation safety and radiation monitoring requirements deriving from radiation practices and the specific characters thereof and other data characterising radiation practices.

§ 71. Application of open proceedings to review of applications for radiation practice licences

In the case of the radiation practices specified in clauses 1, 4 and 5 of subsection 1 of § 68 of this Act, open proceedings apply to issue or amendment of radiation practice licences.

§ 72. Opinion of local governments concerning applications for radiation practice licences

If an application for a radiation practice licence is applied for radiation practices specified in clauses 1, 4 and 5 of subsection 1 of § 68 of this Act, the issuer of licences must submit the application to the local government for its opinion.

§ 73. Time limit for deciding on issue of radiation practice licence and radiation practice registration

(1) Issue of radiation practice licences shall be decided within 90 days as of the receipt of a conforming application.

(2) If a radiation practice licence is applied for high risk radiation practices, the issuer of licences may extend the time limit provided for in subsection 1 of this section by up to 90 days.

(3) Issue of a radiation practice registration is decided within 30 days as of the receipt of a conforming application.

§ 74. Refusal to issue radiation practice licence and radiation practice registration

(1) The issuer of licences shall refuse to issue a radiation practice licence in addition to the cases provided for in § 52 of the General Part of the Environmental Code Act if:

1) the planned practice is not best practice for economic, social or other benefits with regard to potential health detriment caused by the radiation practice;

2) the practice for which the radiation practice licence is applied involves or may involve a risk to national or international security;

3) the applicant for radiation practice licence has no exposed workers with required professional training;

4) the location applied for radiation practice or other terms and conditions do not allow for compliance with radiation safety requirements;

5) the applicant for a radiation practice licence does not prove the existence of the collateral provided for in Chapter 6 of this Act in the amount and on the requirements determined by the issuer of radiation practice licences.

(2) The issuer of registrations refuses to issue a radiation practice registration where:

1) the applicant has knowingly submitted false data which affect the decision on registration of the practice;

2) the practice requires a radiation practice licence;

3) the applicant for a radiation practice licence does not employ exposed workers with required professional training;

4) the location applied for radiation practices and conditions do not allow the radiation safety requirements to be met;

5) the proposed practice does not comply with the requirements established by law.

§ 75. Data subject to entry in radiation practice licence

(1) In addition to the provisions of § 53 of the General Part of the Environmental Code Act, a radiation practice licence shall indicate:

1) number and date of issue of the radiation practice licence;

2) name of radiation practice;

3) data on and description of radiation sources;

4) methods of management of radioactive waste, maximum quantities and management and storage facilities thereof;

5) maximum quantities of radioactive emissions, and modes of release thereof into the environment;

6) requirements for radiation safety and radiation monitoring arising from radiation practice and the specific character thereof;

7) risk level of the radiation practice;

8) existence of financial collateral.

(2) A radiation practice licence issued for radiation practice related to high-activity sources contains the following information in addition to the provisions of subsection 1 of this section:

1) radiation protection competence of the workers, including informing and training of them;

2) requirements for the radiation source, container of the radiation source and additional equipment and their maintenance;

3) proper radiation safety management of disused sources until delivery thereof to a manufacturer, another person holding the radiation practice licence or radioactive waste storage facilities.

(2¹) A radiation practice licence and the decision on issue thereof shall be prepared via the Information System for Environmental Decisions and signed digitally.

(3) The data composition of radiation practice licences shall be established by a regulation of the minister in charge of the policy sector.

§ 75¹. Data subject to entry in radiation practice registration

(1) A radiation practice registration states the following:

1) the name or designation and personal identification code or registry code of the holder of the registration;

2) the exact location of the site and a site plan;

3) the registration application number;

4) the registration number and date of issue;

5) the name of radiation practices;

6) the data of radiation sources;

7) the requirements for radiation safety and radiation monitoring arising from the radiation practices and their specific character;

8) the obligations of the holder of a radiation practice registration.

(2) The more detailed data content of the radiation practice registration is established by the minister in charge of the policy sector by a regulation.

§ 76. Validity of radiation practice licences

(1) The term of validity of a radiation practice licence in the case of low risk radiation practices is determined according to subsection 2 of § 53 of the General Part of the Environmental Code Act.

(2) In the case of moderate and high risk radiation practices, a radiation practice licence is issued for a term of up to five years.

§ 76¹. Validity of registration of radiation practices

The radiation practice registration is issued without a term, unless a registration for a specified term is requested.

§ 77. Amendment and revocation of radiation practice licences

(1) A radiation practice licence is amended or revoked pursuant to the procedure provided for in §§ 59, 60 and 62 General Part of the Environmental Code Act.

(2) In the cases provided for in clauses 1, 3, 4, 5 and 7 of subsection 1 of § 78 of this Act, the Environmental Board shall decide on amendment of the radiation practice licence within 30 days as of receipt of the application.

(3) In addition to the provisions of § 62 of the General Part of the Environmental Code Act, a radiation practice licence is revoked if:

1) the holder of a licence does not ensure existence of a financial collateral;

2) the holder of a licence has repeatedly failed to ensure compliance with radiation safety principles, obligations and the requirements provided for in the licence involving a serious risk of radiation;

3) the holder of a licence, its representatives or employees have purposefully and in bad faith prevented the Environmental Board and its representatives from controlling the practice of the holder of the licence.

(4) The issuer of licences has the right to initiate a procedure for repeal of a radiation practice licence where all the radiation sources indicated in the radiation practice licence have been rendered safe.

§ 77¹. Modification and cancellation of registration of radiation practices

(1) A person who has registered their radiation practices is required to immediately inform the issue of licences of any changes in their designation, registry code, name, personal identification code or contact details, and change or termination of the radiation practices, and other circumstances which may affect the practices permitted on the basis of the registration, and to apply for the amendment of the registration or a new registration.

(2) Amendment of a radiation practice registration is decided within 30 days as of the receipt of a conforming application.

(3) The issuer of registrations revokes the radiation practice registration where:

1) the holder of the registration submits an application for this purpose;

2) the grounds for refusal of registration provided in subsection 2 of § 74 of this Act becomes evident.

(4) The issuer of registrations has the right to initiate proceedings for repeal of radiation practice registrations where all radiation sources indicated in the registration have been rendered safe.

§ 78. Changes in radiation practices

(1) A holder of a radiation practice licence shall submit an application to the issuer of licences via the Information System for Environmental Decisions, if the holder intends to:

1) commission new or additional radiation sources;

2) change the data of the radiation source indicated in the radiation practice licence or terminate the use thereof;

3) deliver the radiation source to another person or dispose of it as radioactive waste;

4) change the radiation practice, method of management, maximum quantities or storage facilities of produced radioactive waste determined in the radiation practice licence;

5) change the location, facilities or premises where the radiation practice is carried out;

6) employ a new radiation safety specialist;

7) significantly change the radiation practice described in the licence in any other manner.

(2) In the cases provided for in clauses 1, 4, 5 and 7 of subsection 1 of this section, if the amendment is significant from the point of view of radiation safety, the specified notices shall be treated as an application for a new radiation practice licence.

(3) A holder of a radiation practice registration submits an application to the issuer of registrations through the environmental decisions information system where they intend to:

1) introduce a new or additional radiation source;

2) amend the data of the radiation source indicated in the radiation practice registration or terminate its use;

3) amend the radiation practices specified in the radiation practice registration;

4) amend the place or premises where the radiation practices are carried out.

§ 79. Radiation practice licences for operation of nuclear facilities

A radiation practice licence for the operation of a new nuclear facility can be applied for after the Riigikogu has adopted a decision on commissioning of a nuclear facility.

§ 79¹. State fee for applying for and amending of radiation practice licence and registration practice registration

(1) When applying for a radiation practice licence or a radiation practice registration, the applicant pays a state fee in accordance with the rules provided in the State Fees Act.

(2) A state fee is paid for review of an application for amendment of a radiation practice licence and radiation practice registration at the rate provided in the State Fees Act.

§ 82. Application for transport permits

(1) Applications for transport permits are submitted separately for each transportation.

(2) An application for transport permits may be submitted for more than one transportation, provided that:

1) all radioactive waste for the transportation of which the application is submitted has similar physico-chemical and radioactive properties;

2) the transportation takes place from the same possessor of radioactive waste to the same recipient, and the transport documents have been approved and issued by the same competent authorities;

3) the transportation takes place through the same border checkpoints and the same transit countries.

(3) An application for a radiation practice licence for transportation of radioactive waste (hereinafter transport permit) shall be submitted to the Environmental Board in electronic form and signed digitally.

§ 83. Documents for importation, exportation or transit of radioactive waste

(1) Documents for importation, exportation or transit of radioactive waste include:

1) application for transport permit;

2) approval by competent authorities;

3) transport permit;

4) list of packagings;

5) notice on receipt of radioactive waste.

(2) The specifications of the procedure for processing of documents for importation, exportation or transit of radioactive waste and the time limits thereof based on the countries of origin and destination shall be established by a regulation of the minister in charge of the policy sector.

(3) The standard formats of documents for importation, exportation or transit of radioactive waste are set out in the Commission Decision 2008/312/Euratom of 5 March 2008 establishing the standard document for the supervision and control of shipments of radioactive waste and spent fuel referred to in Council Directive 2006/117/Euratom (OJ L 107, 17.04.2008, pp. 32-59).

§ 84. Approval of transport permits and transit

(1) The Environmental Board shall send applications for transport permits and transit to competent authorities of the country of destination and all countries of transit for approval.

(2) The Environmental Board shall issue a transport permit after receipt of approvals of all appropriate authorities.

§ 85. Validity of approvals of transport permits and transit

(1) Single transport permits and approvals of transit are issued for one carriage for a specified term.

(2) Multiple transport permits and approvals of transit shall be valid for the term of up to three years.

§ 86. Refusal to issue transport permits and approve transit

In addition to the provision of § 74 of this Act, the Environmental Board shall refuse to issue transport permits and approve transit of radioactive waste if:

1) the country of destination of the radioactive waste is south of 60° south latitude;

2) the country of destination is not a member state of the European Union but it has entered into a contract prohibiting importation or transit of radioactive waste with the European Union;

3) there is reason to believe that it is not possible to manage radioactive waste safely in the country of destination;

4) the radioactive waste is intended to be imported into Estonia for intermediate storage or final disposal.

§ 87. Returning of radioactive waste

If it is impossible to complete the transportation of radioactive waste or if the requirements for the transportation do not comply with the requirements set out in the application for the transport permit, the Environmental Board shall apply substitutional performance in the form of returning the radioactive waste to its initial owner pursuant to the procedure provided for in the Substitutional Performance and Non-Compliance Levies Act.

§ 88. Importation, exportation and transit of spent fuel

The provisions of this Subchapter also apply to importation, exportation and transit of spent fuel.

§ 89. Radiation experts

(1) A radiation expert is a person who consults holders of radiation sources and other persons to the extent of his or her knowledge and skills. Radiation experts consult, inter alia, in the following areas:

1) ) taking into account of radiation safety requirements when designing facilities intended for radiation practices;

2) classifying of jobs at the location of radiation practice into control and surveillance areas;

3) monitoring programmes for locations of radiation practices;

4) protective equipment and measuring equipment, including the selection and control thereof;

5) preparation of radiation safety quality management systems;

6) safe management of radioactive waste;

7) risk analyses and radiological emergency response plans;

8) training of radiation workers and radiation safety specialists;

9) taking into service of new or modified radiation sources.

(2) Any natural person holding a respective certificate or an authorised person may act as a radiation expert.

§ 90. Certificates of radiation experts

(1) Certificates of radiation experts are issued based on applications to persons who:

1) have higher education;

2) have passed radiation safety training which study programme includes radiation safety principles and the Republic of Estonian and European Union legislation and relevant international recommendations and subjects discussing ionizing radiation to such an extent that it allows to operate in the area specified in the certificate;

3) have at least five years of practical experience in the field of radiation safety;

4) have passed the examination for radiation experts;

(2) The certificates of radiation experts shall be issued by the Environmental Board.

(3) For review of an application for a certificate of radiation expert, the applicant shall pay a state fee in the rate provided for in the State Fees Act.

(4) The minister in charge of the policy sector shall establish by a regulation the curriculum for training of radiation experts, their professional skills requirements, the procedure for application for the certificate and the standard format of applications and certificates.

§ 91. Validity of certificates

A certificate shall be valid for the term of five years.

§ 92. Refusal to issue certificates

The Environmental Board shall refuse to issue a certificate if:

1) the person does not meet the requirements provided for in subsection 1 of § 90 of this Act;

2) the person has significantly violated the requirements of the Radiation Act and the legislation issued on the basis thereof with his or her earlier activities within three years before application for the certificate;

3) the certificate has been revoked within three years before the application for a new certificate.

§ 93. Revocation of certificate

The Environmental Board shall revoke the validity of a certificate upon notifying the holder thereof in writing in advance if:

1) the holder of the certificate has submitted inaccurate information about his or her education, passing of radiation safety training or work experience;

2) the holder of the certificate does not comply with the radiation safety principles.

§ 94. Recognition of foreign professional qualifications

(1) Persons who have acquired foreign professional qualifications may be employed as radiation experts if their professional qualifications have been recognised in accordance with the Recognition of Foreign Professional Qualifications Act.

(2) The competent authority according to subsection 2 of § 7 of the Recognition of Foreign Professional Qualifications Act is the Environmental Board.

§ 95. Medical physics expert

(1) A medical physics expert acts, consults and participates to the extent of his or her knowledge and skills in the medical field:

1) upon use of medical radiology devices in any issues relating to radiation physics;

2) in any issues relating to patient dosimetry;

3) upon optimization of medical exposure;

4) upon quality assurance of medical radiological procedure;

5) upon running approval tests of medical radiology devices;

6) in the process of procuring and assessment of medical radiology devices, protective equipment and measuring equipment;

7) upon preparation of the technical specification of medical radiology devices and facilities;

8) in the analysis of such events which involve or potentially involve accidental or unintended medical exposures;

9) in the training of exposed workers.

(2) Approval tests mean the tests of medical radiology devices immediately before the first use or after any reconstructions for checking the prescribed safety and performance characteristics of the device and determining the baseline values of performance characteristics.

(3) Any natural person who has a professional certificate of a biomedical technology engineer or equal thereto in the speciality of diagnostic radiology, nuclear medicine or radiation therapy may act as a medical physics expert.

§ 96. Increased natural exposures

(1) The Environmental Board shall ensure that by means of surveys or other appropriate methods all such actions are ascertained in the case of which natural radiation sources or naturally occurring radioactive materials may cause exposure to workers or members of the public in excess of the effective dose limits established for members of the public on the basis of this Act.

(1¹) Natural radiation source means a source of ionising radiation of natural, terrestrial or cosmic origin.

(2) The activities in the case of which natural radiation sources or naturally occurring radioactive materials may cause exposures to workers or members of the public in excess of the effective dose limits established for members of the public on the basis of this Act inter alia include:

§ 97. Measures to protect workers and members of public

(1) In the case of any activities in the case of which natural radiation sources may cause exposures to workers or members of the public in excess of the effective dose limits established for members of the public on the basis of this Act, the Environmental Board shall have the right to demand from the employer:

1) submission of radiation safety assessments;

2) organisation of monitoring of the doses resulting from exposures;

3) taking into account of the assessed exposure when organising work schedules;

4) informing of workers of the health risks related to their work and appropriate guidance;

5) implementation of special measures for the protection of the health of female workers during pregnancy and, if necessary, during breastfeeding;

6) taking of appropriate measures in order to prevent the opportunity that any workers and members of the public incur any doses which exceed the effective dose limit of members for the public established pursuant to this Act or minimize it.

(2) If, in the opinion of the Environmental Board, implementation of the measures provided for in subsection 1 of this section is insufficient and the workers may incur an annual effective dose which exceeds the effective dose limit for members of the public, the employer must apply for a radiation practice licence.

(3) The minister in charge of the policy sector shall establish by a regulation the reference levels for indoor radon concentrations in workrooms, the procedure for radon measurements and obligations of employers at workplaces with an increased radon risk.

§ 97¹. Measures for protection of cabin crews and spacecraft crews

(1) In order to protect flight crews in the case they may incur exposures to cosmic radiation in excess of the annual effective dose limit for members of the public established by this Act, the employer must:

1) organise monitoring of the doses caused by the exposures;

2) take into account the amount of doses when preparing work schedules;

3) inform the workers of the health risks related to their work;

4) apply special measures for the protection of the health of female workers during pregnancy.

(2) Where the radiation dose of a worker exceeds 6 millisieverts in a year, the employer must, in addition to the provisions of subsection 1 of this section:

1) have the measures implemented for the protection of workers by the Environmental Board;

2) ensure the medical examination of workers at least once a year.

(3) The measures implemented in order to protect spacecraft crews in the case they may incur exposures due to cosmic radiation in excess of the annual effective dose limit for exposed workers established pursuant to this Act shall be approved by the Environmental Board.

(4) For the purposes of this Act, a spacecraft is a manned vehicle designed to operate at an altitude of more than 100 km above sea level.

§ 98. Financial collateral

(1) The issuer of radiation practice licences may require that applicants for radiation practice licences have financial collaterals to recover radioactive substances, equipment containing thereof and radioactive waste (hereinafter collateral).

(2) The issuer of radiation practice licences shall decide on the need for collateral within 20 days as of registration of an application for a radiation practice licence or the amendment thereof. The importance of ensuring recovery of radioactive substances, equipment containing thereof or radioactive waste from the radiation safety point of view and the estimated cost of recovery shall be taken into account upon making the decision.

(3) The collateral must be only intended for recovery of radioactive substances, equipment containing thereof and radioactive waste and it must be immediately realizable, if appropriate.

(4) The amount of collateral shall be the estimated cost of recovery of radioactive substances, equipment containing thereof or radioactive waste on the basis of the data submitted by the applicant of a radiation practice licence and it shall be determined by the issuer of the radiation practice licence.

(5) The availability of collateral shall be certified by a guarantee of an Estonian or international credit or financial institution accepted by the issuer of radiation practice licences. The issuer of radiation practice licences has the right to refuse to accept any issuer of guarantees if there are reasons to doubt the reliability of the guarantee issued by such issuer on the basis of the former activities, financial status or reputation of the issuer of the guarantee.

(6) Collateral must be valid up to the end of the recovery of radioactive substances, equipment device containing thereof or radioactive waste.

§ 99. Increase of collateral

If the issuer of radiation practice licences establishes that the amount of the existing collateral no longer covers the costs of recovery of radioactive substances, equipment containing thereof or radioactive waste, it has the right to demand that the collateral is increased.

§ 100. Assessment of effective and equivalent doses of members of public and reference groups of population

(1) The Environmental Board shall ensure dose assessment for members of the public and reference groups of the population.

(2) A reference group of the population is a group of persons whose exposure incurred from any radiation practices is uniform and who represents the most exposed part of the population for this radiation practice.

(3) A holder of a radiation practice licence who holds a licence for radiation practices provided for in clauses 1, 4 or 5 of subsection 1 of § 68 shall ensure assessment of the doses incurred by reference groups of the population.

(4) The procedure for monitoring and assessment of effective doses of members of the public, the dose coefficient values for doses resulting from radionuclide intake and the procedure for measuring thereof and radiation and tissue weighting factor values shall be established by a regulation of the minister in charge of the policy sector.

§ 101. Assessment of effective and equivalent doses of exposed workers

(1) Holders of radiation practice licences shall ensure the assessment of effective and equivalent dose incurred by exposed workers.

(2) The procedure for monitoring and assessment of effective doses of exposed workers, the dose coefficient values for doses resulting from radionuclide intake and the procedure for measuring thereof and radiation and tissue weighting factor values shall be established by a regulation of the minister in charge of the policy sector.

§ 102. Dose register

(1) A national dose register of exposed workers shall be maintained for keeping records on occupational exposure doses incurred by exposed workers.

(2) The controller of the national dose register of exposed workers is the Environmental Board.

(3) The national dose register of exposed workers contains the personal data of exposed workers, data on their employers and incurred doses of occupational exposure.

(4) The data specified in subsection 3 of this section must be preserved in the national dose register of exposed workers during the entire time the exposed worker is engaged in radiation works. Thereafter the data shall be preserved until the time the person attains or would have attained 75 years of age but not for a shorter period than 30 years after the person no longer engages in radiation works.

(5) The following persons shall be enabled access to the results of the individual dose monitoring of exposed workers:

1) the exposed worker himself or herself with regard to the data concerning him or her;

2) the expert providing occupational health services to an exposed worker;

3) the holder of a radiation practice licence with regard to the information concerning the exposed workers of such holder;

4) the persons carrying out radiation safety inspection;

5) the persons carrying out scientific research on exposure and the influences thereof to the extent of the data which do not concern the person of any exposed worker.

(6) The national dose register of exposed workers and the statutes thereof shall be established by a regulation of the minister in charge of the policy sector.

§ 103. Intervention

Intervention is human activity directed to sources, exposure pathways and persons which is used to prevent or decrease human exposure in accidental and existing exposure situations.

§ 104. Exposure pathways

Exposure pathway is a route in the environment through which a radioactive substance moves to a person and causes exposure to the person.

§ 105. Intervention, action and reference levels

(1) An intervention level is the predicted dose value above which measures to protect members of the public must be considered.

(1¹) A predicted dose is a dose that is expected to be received in an emergency or existing exposure situation where no protective measures are taken.

(2) Action level is the value of dose rates or activity concentrations upon the exceeding of which protective measures are implemented.

(2¹) Reference level means in an emergency exposure situation or in an existing exposure situation the level of effective dose, equivalent dose or activity concentration above which taking of measures has to be considered for decreasing the radiation, even though it is not any limit that may not be exceeded.

(3) Intervention and action levels and reference levels of emergency exposure which constitute the basis for preparation of radiological emergency plans and implementation of measures for protecting the members of the public shall be established by a regulation of the Government of the Republic.

§ 106. Protective and remedial measures and principles of implementation thereof

(1) The method, extent and duration of implementation of protective measures shall be planned in a manner that the benefit of decreased health detriment of people is maximum compared to the damage caused by intervention.

(1¹) Protective measures mean measures, other than remedial measures, which are implemented for the purpose of avoiding or reducing doses that might otherwise be received in an emergency exposure situation or an existing exposure situation.

(1²) Remedial measures include removal of a radiation source or reduction of its power or interruption of exposure pathways or reduction of their impact for avoiding or reducing doses that might otherwise be received in an emergency or existing exposure situation.

(2) Preventive measures are implemented if the decrease in detriment is sufficient to justify the damage and costs of implementation of protective measures.

§ 107. Intervention in emergency exposure situations

(1) Participants in the intervention are the Rescue Board on the basis of and pursuant to the procedure provided for in the Rescue Act, the Police and Border Guard Board on the basis of and pursuant to the procedure provided for in the Police and Border Guard Act, the Environmental Board, the manager of radioactive waste participating in the intervention and, as appropriate, any other persons.

(2) The Environmental Board is competent to:

1) assess possible dispersion of radioactive substances in time and space and possible incurred exposures;

2) ascertain areas of increased exposure and organise radiation monitoring in these areas;

3) carry out measurements and provide an assessment on exceeding or not exceeding the criteria for radioactive contamination;

4) assessment and documentation of radiation doses of persons who stayed in an area of heightened radiation levels;

5) exchange of information on radiation with the European Commission and the International Atomic Energy Agency.

(4) Managers of radioactive waste who participate in intervention are legal persons holding a radiation practice licence for management of a radioactive waste storage facilities and transportation of radioactive substances and have capability for removal of contamination from radioactively contaminated areas.

(5) The minister in charge of the policy sector appoints by a directive a radioactive waste manager who participates in the intervention or enters into an administrative contract for the performance of the task of intervention under the conditions specified in subsection 5 of § 61 of this Act.

§ 109. Intervention in existing exposure situations

The Environmental Board shall ensure, by means of research or other relevant measures, that any existing exposure situation resulting from emergency expose or past activities and prepare situation management plans which contain at least the following:

1) specification of the existing exposure situation;

2) objectives of management of the existing exposure situation;

3) form, scale and duration of optimised remedial and protective measures;

4) obligations relating to implementation of remedial and protective measures;

5) environmental radiation monitoring programme;

6) relevant reference levels of the existing exposure situation which must be in the range of 1-20 millisieverts in a year;

7) terms and conditions for habitation and social and economic activities in areas with long-lasting residual contamination;

8) strategy of informing the public of implementation of remedial and protective measures, course of addressing the existing exposure situation, potential health risks and monitoring results.

§ 110. Medical examination of persons in areas affected by emergency exposure

(1) Where necessary, the Environmental Board ensures the assessment, monitoring of individual doses of emergency or emergency occupational exposure and submission of assessment results to a physician who performs the medical examination.

(2) The medical examination costs are covered by the state budget and are later collected from the person who caused the emergency exposure situation.

§ 111. Radiation hazard early notification system

The Environmental Board shall ensure the operation of the radiation hazard early notification system.

§ 112. State supervision

(1) The Environmental Board exercises state supervision over radiation safety.

(2) Supervision over the requirements of the regulation established pursuant to subsection 3 of § 97 of this Act shall be exercised by the Labour Inspectorate and the Environmental Board pursuant to the provisions of the regulation.

§ 114. Use of direct coercion

(1) The Environmental Board is authorized to use physical force, special equipment and service weapons on the grounds and in accordance with the rules provided in the Law Enforcement Act.

(2) The special equipment of the Environmental Board consist of handcuffs.

(3) The service weapons of the Environmental Board are a gas weapon and a cut-and-thrust weapon.

§ 115. Non-compliance levy rate

Upon failure to comply with a precept, the upper limit of non-compliance levy pursuant to the procedure provided for in the Substitutional Performance and Non-Compliance Levies Act is 32,000 euros.

§ 116. Obligations arising from international agreements

International inspectors who check the compliance with the terms and conditions of international agreements binding on the Republic of Estonia shall have access to all the objects in the scope of regulation of these international agreements and to relevant data, and they have the right to take samples.

§ 117. Operation without radiation practice licence or in violation of requirements of licence

(1) Operation without a radiation practice licence, if the licence is required, and in violation of the requirements of the licence

is punishable by a fine of up to 300 fine units.

(2) The same act, if committed by a legal person,

is punishable by a fine of up to 20,000 euros.

§ 117¹. Practice without or in breach of requirements for radiation practice registration

(1) Practice without a radiation practice registration, where the registration was required, or in breach of the registration requirements –

is punishable by a fine of up to 150 fine units.

(2) The same act, where committed by a legal person, –

is punishable by a fine of up to 10,000 euros.

§ 118. Violation of obligations of radiation practitioner

(1) Violation of obligations of a radiation practitioner provided in this Act –

is punishable by a fine of up to 300 fine units.

(2) The same act, if committed by a legal person,

is punishable by a fine of up to 20,000 euros.

§ 119. Manufacture of goods containing radioactive substances

(1) Addition of radioactive substances upon manufacture of foodstuffs, animal feed, toys or jewellery or activation upon manufacture of toys or jewellery the materials used therein

is punishable by a fine of up to 300 fine units.

(2) The same act, if committed by a legal person,

is punishable by a fine of up to 32,000 euros.

§ 120. Transportation of sources containing radioactive substances and radioactive waste and goods across state border

(1) Transportation of sources containing radiation substances, radioactive waste or goods listed in § 119 across the state border without an appropriate authorisation

is punishable by a fine of up to 300 fine units.

(2) The same act, if committed by a legal person,

is punishable by a fine of up to 20,000 euros.

§ 121. Delivery of radiation source containing radioactive substance and delivery of radioactive waste to person who does not hold radiation practice licence or have radiation practice registration

(1) Delivery of a radiation source containing a radioactive substance and delivery of radioactive waste to a person who does not hold a radiation practice licence or have a radiation practice registration –

is punishable by a fine of up to 300 fine units.

(2) The same act, if committed by a legal person,

is punishable by a fine of up to 20,000 euros.

§ 122. Proceedings

Extra-judicial proceedings concerning the misdemeanours provided for in this Chapter shall be conducted by the Environmental Board.

§ 123. Validity of low risk radiation practice licences

Low risk radiation practice licences issued for a specified term prior to the entry into force of this Act shall remain in force until the date of expiry set out therein.

§ 124. Proceedings for issue of low risk radiation practice licences

Proceedings for issue of low risk radiation practice licences commenced prior to entry into force of this Act shall be conducted pursuant to the General Part of the Environmental Code Act and this Act.

§ 124². Transition to registration of radiation practices

(1) A person who has been issued a radiation practice licence for a practice requiring radiation practice registration may submit an application to the Environmental Board for issue of a registration for the same practice.

(2) When submitting an application in accordance with subsection 1 of § 78 of this Act for amendment of a radiation practices licence issued prior to entry into force of this section, an application is also submitted for issue of a registration for a radiation practice indicated in the licence and requiring radiation practice registration.

(3) When satisfying an application radiation practice registration, the Environmental Board repeals the radiation practice licence to the extent in which the registration was issued.

(4) In the cases provided in this section, an applicant for radiation practice registration is exempt from payment of a state fee.

§ 124³. Processing of application for radiation practice licence and application for amendment of radiation practice licence prior to establishment of radiation practice registration

An application for a radiation practice licence and an application for amendment of a radiation practice licence submitted prior to establishment of the radiation practice registration is governed by the Act in force at the time of processing the application.

§ 125

–

§ 126

[Omitted from this text.]

§ 127. Entry into force of Act

This Act and the fifth chapter of the General Part of the Environmental Code Act enter into on 1 November 2016.