Applications of ionizing radiation sources
Attention!
As of 15.06.2016, in view of the staff shortage faced by the Division for the Authorization of the Use of Ionizing Radiation, as well as the large volume of work, we are no longer able to process applications for authorization under the urgent procedure.In this context, until the organizational matters are resolved, applications and documentation for the issuance of authorizations under the urgent procedure will no longer be accepted.
As of 1 October 2015, authorization files shall be submitted only by post or by courier service, and not through natural persons (radiation protection experts or representatives of the authorization applicants), by e-mail or by fax.
The documentation shall be submitted in a file folder with a fastener, containing the list of documents relevant to the specific type of authorization, as well as an electronic medium (CD) with the scanned documents.
Nuclear activities involving radiation sources that do not involve criticality - installations with sealed or unsealed sources, radioactive materials, ionizing radiation generating devices, dosimetric control equipment, materials and equipment for protection against ionizing radiation, means of containerization or transport - are controlled through the authorization process and the inspection regime applied to authorization applicants or holders, in accordance with the provisions of Law no. 111/1996, republished, and with the norms and regulations specific to the field of radiological safety drawn up by CNCAN.
Authorization system
Legal requirements
The activities and sources provided for in Article 2 of Law no. 111/1996, republished, require an authorization issued by the Commission, in compliance with the authorization procedure specific to each type of activity or source.
The following activities in the nuclear field and sources require an authorization issued by DASRI:
a) the research, design, siting, production, construction, assembly, commissioning, operation, supply, leasing, import and export of radiological installations;
b) the production, supply, leasing, transfer, handling, possession, processing, treatment, use, storage or disposal, transport, transit, import and export of radioactive materials, radioactive waste and ionizing radiation generating devices;
c) the supply and use of dosimetric control equipment for ionizing radiation, of materials and devices used for protection against ionizing radiation, as well as of means of containerization or transport specially designed for this purpose.
Exemption from the authorization regime for use is regulated by Articles 8, 9, 10 and 11 of the Fundamental Norms on Radiological Safety approved by Order no. 14/2000 of the President of the National Commission for Nuclear Activities Control, published in the Official Gazette of Romania, Part I, no. 404 bis of 29 August 2000
Activities and practices in the nuclear field must be carried out in compliance with the following requirements:
a) the working areas must be appropriately arranged, optimally sized and clearly delimited, including by physical barriers where applicable;
b) there must be an adequate signalling and information system;
c) there must be individual and collective radiation protection equipment in the necessary quantities and of appropriate quality;
d) there must be a system for the assessment of individual doses accepted by the Commission;
e) there must be adequate radiometric measuring equipment;
f) the management of the radioactive waste generated by the authorized activity must be organized;
g) the periodic verification of the radiological installations must be ensured, in accordance with the manufacturer's recommendations or with the Commission's requirements;
h) the leak testing of radioactive sources must be ensured at least once every 6 months or in accordance with the Commission's requirements;
i) a radiological safety officer must be designated for each controlled area;
j) the services of a radiation protection expert must be available, either through a consultancy contract or through direct employment;
k) a system of local rules in accordance with the principles of radiation protection must be implemented and maintained;
l) the work must be organized under a quality assurance system.
The authorization regime
The authorization system is implemented through one of two components: a) registration;
b) authorization.
Registration is the operation by which applicant legally established entities are authorized to possess, to site and construct, to use and to decommission, through authorized units, the radiation sources and radiological installations that are subject to registration, in compliance with the provisions of the law, of the specific regulations and of the instructions for use.
Registration is applied for by classes of radiation sources or radiological installations.
The rights acquired on the basis of registration may not be transferred without the consent of the Commission.
Registration may be applied for only for radiation sources and radiological installations that hold a radiological safety authorization for the product valid on the date of the initial registration.
The use of radiation sources and radiological installations that cannot be exempted from the authorization regime and that meet at least one of the following conditions is subject to registration:
a) they are classified and used as standard sources, calibration sources or test sources and the activity of each does not exceed 370 MBq;
b) radiological installations that contain alpha or beta emitting sources and do not require the presence of an operator;
c) radiological installations that contain gamma emitting sources whose activity does not exceed 3.7 GBq and that do not require the presence of an operator;
d) radiological installations that contain radiation generators and do not require the presence of an operator or, where the operator's presence is necessary, the operator does not have access, and access is not necessary, to the direct radiation beam during the normal working process;
e) radiological installations containing radiation generators that are used in intraoral dental X-ray diagnosis and in radiodiagnosis and whose X-ray tube high voltage does not exceed 80 kV;
f) they are classified as such in the radiological safety authorization for the product issued by the Commission.
Activities involving the presence of the natural radiation sources mentioned in Article 91 of the Fundamental Norms on Radiological Safety are subject to registration, if the Commission has so decided pursuant to Article 92 of the said Norms.
The registration certificate constitutes proof of the registration of the radiation source or radiological installation and represents the legal basis for carrying out the permitted nuclear activities.
The conditions and limits imposed in the certificate are equivalent to the conditions and limits imposed in an authorization.
The technical documentation on the basis of which the registration certificate was issued forms an integral part of the registration. Its unilateral modification by the applicant is prohibited and leads to the cancellation of the registration.
Registration precedes the performance of the activities in the nuclear field.
The authorization is the official document issued by the Commission whereby the holder is granted the right to carry out activities in the nuclear field, and it has the status of an official document. The rights obtained on the basis of the authorization may not be transferred without the consent of the Commission.
The authorization is the act that proves the legality of the activities in the nuclear field.
The authorization is valid only for the holder and only for the nuclear activities or practices for which it was issued.
Compliance with the limits, conditions and deadlines entered in the authorization or in the annexes accompanying it is mandatory.
The technical documentation on the basis of which the authorization was issued forms an integral part of the authorization. Its unilateral modification by the applicant is prohibited and leads to the cancellation of the authorization.
The authorization precedes the performance of the activities in the nuclear field.
Applying for registration or authorization
Applying for registration is mandatory within a maximum of 15 working days from the date on which the product subject to registration was acquired.
Applying for and obtaining authorization is mandatory before the start of the activity in the nuclear field; applying for authorization is mandatory within a maximum of 15 working days from the date on which the product subject to authorization was acquired.
The date of the application is proven by the date of the acknowledgement of receipt of the postal item or by the date of registration in the Commission's incoming correspondence register.
For practices that are authorized in a single stage, users must notify the Commission, no more than six months in advance, of their intention to use the respective radiological installations or radiation sources. The notification letter shall be completed in accordance with form no. 2 in Annex no. 1 to the Radiological Safety Norms – Authorization Procedures.
For practices that are authorized by registration, users must notify the Commission of their intention to use at least 15 days in advance. The notification letter shall be completed in accordance with form no. 1 in Annex no. 1 to the Radiological Safety Norms – Authorization Procedures.
The notification allows the procurement of the radiological installations and radiation sources, their assembly and testing, and the testing of the effectiveness of the protective shielding.
Registration or authorization is applied for by submitting or sending to the Commission an authorization file, in two copies, either for authorization or for registration, consisting of:
a) an application, completed in accordance with form no. 3, form no. 4 or form no. 5, respectively, in Annex no. 1 to the Radiological Safety Norms – Authorization Procedures;
b) proof of payment of the fees and tariffs (Regulation on fees and tariffs);
c) copies of the documents proving that the applicant is a legally established entity;
d) technical documentation for authorization;
e) copies of the authorizations or endorsements issued by other state bodies, required by law;
f) other information deemed necessary by the applicant in support of the application.
Technical documentation for registration
File for authorization by REGISTRATION
1. Application;
2. Copies of the documents proving that the applicant is a legally established entity;
3. Technical documentation;
4. Copies of the authorizations or endorsements issued by other state bodies, required by law;
5. Other information deemed necessary by the applicant in support of the application;
6. Proof of payment of the fee and tariff (Regulation on fees and tariffs).
· The technical documentation for registration shall specify, as applicable:
· The type of source or radiological installation;
· The design variant;
· The components;
· The maximum parameters;
· The identification data;
· The year of manufacture;
· The supplier
· The quantity
· The date on which the product was obtained;
· The uses to which it is put;
· The location within the legal person;
· The manner in which the instructions for use are complied with;
· The necessary radiation protection measures;
· The verification and testing interval.
· The documentation shall be accompanied by a copy of the invoice or of another document proving the origin and, where applicable, by a copy of the acceptance tests performed by the installer.
· The documentation shall contain the details of the responsible person, stating the practice permit, the general training and the training in the nuclear field.
- TYPES OF AUTHORIZATIONS
1. Radiological safety authorization for the product
The radiological safety authorization for the product is the document issued by the Commission on the basis of Law no. 111/1996, which certifies that the product complies with the requirements of the regulations in the nuclear field and may be the subject of authorized activities in the nuclear field, for the purpose for which it was designed and manufactured.
The radiological safety authorization for the product is applied for in respect of each distinct type of radioactive material, radiological installation, ionizing radiation generating device, equipment for the dosimetric control of ionizing radiation or of the degree of radioactive contamination, material or device used for the purpose of protection against ionizing radiation, or means of containerization or transport specially designed for this purpose, which the authorization applicant intends to manufacture or import with a view to its use or marketing.
The authorization is issued at the request of the legally established entity that intends to manufacture or import the respective product.
FILE for the authorization of the product - RADIOLOGICAL SAFETY AUTHORIZATION
1. Application;
2. Copies of the documents proving that the applicant is a legally established entity;
3. Technical documentation for authorization;
4. Copies of the authorizations or endorsements issued by other state bodies, required by law;
5. Other information deemed necessary by the applicant in support of the application;
6. Proof of payment of the fee and tariff (Regulation on fees and tariffs).
· The technical documentation for authorization required to obtain the radiological safety authorization for the product must contain, as applicable, sufficient information on:
· design and manufacture;
· the testing programme and its results;
· the quality assurance system;
· the purpose for which it was designed;
· installation, assembly, maintenance;
· operation / use;
· labelling, marking;
· servicing, repair;
· the accompanying documentation;
· the method of decommissioning or of disposal as waste;
· other hazards it may generate.
· The technical document characterizing the product may also be drawn up in English or in French.
· The applicant must submit, at the request of the Commission, copies of the international or national documents or regulations with which it claims to comply, in Romanian, English or French.
· The operating manual or the instructions for use must be drawn up in Romanian and submitted in the form in which they are supplied to users.
2. Radiological safety authorization for carrying out activities in the nuclear field
The radiological safety authorization for carrying out activities in the nuclear field covers:
a) the siting, production, construction, assembly, commissioning, operation, modification, decommissioning, import and export of radiological installations;
b) the production, supply, leasing, transfer, handling, possession, processing, treatment, use, storage or disposal, transport, transit, import and export of radioactive materials, radioactive waste and ionizing radiation generating devices;
c) the supply and use of dosimetric control equipment for ionizing radiation, of materials and devices used for protection against ionizing radiation, as well as of means of containerization or transport specially designed for this purpose.
The radiological safety authorization for carrying out activities in the nuclear field is the document issued by the Commission on the basis of Law 111/1996 whereby the holder is permitted to carry out nuclear activities within the limits and under the conditions stated in the document and in compliance with the provisions of the applicable regulations in the nuclear field.
The authorization is issued at the request of the legally established entity, for an activity in the nuclear field or for a practice, in which case the authorized activities included in that practice are specified.
The supply and use of dosimetric control equipment for ionizing radiation are permitted if such equipment holds the radiological safety authorization for the product.
Practices and activities that do not meet the conditions for exemption or registration are subject to authorization.
Separate authorizations are issued for each of the following practices and activities:
a) import, export;
b) leasing, supply;
c) transfer;
d) transit;
e) use;
f) production;
g) handling;
h) possession;
i) transport, shipment
3. Import – export authorization
The import or export authorization is issued for each shipment and/or class of products and permits the import or export operations and the supply operations for those products.
Only products that have obtained the radiological safety authorization for the product may be imported or exported.
The importer must meet the legal conditions for the possession of radiological installations or radiation sources. In the case of import on a commission basis, this condition must be met by the final consignee, who shall be named in the authorization.
In the case of radioactive sources or radiological installations containing radioactive sources, the importer or exporter must ensure, in advance, that the beneficiary meets the legal conditions for taking possession of the products.
Packages with radioactive sources or radiological installations containing radioactive sources that are not delivered to the beneficiaries within a reasonable period of time, regardless of the reason, must be returned to the consignor, at the expense of the importer or exporter, as applicable.
The import of radioactive sources for which the method of disposal as radioactive waste has not been established is prohibited.
By way of exception from the applicable provisions above, radiological installations and radioactive materials or radiation sources that have not obtained the radiological safety authorization for the product may be imported or exported in the following cases:
a) the radiation sources constitute the components of a radiological installation or the raw material for the manufacture of radiation sources that have obtained the radiological safety authorization for the product;
b) the import is made for the importer's own use, with the obligation to obtain the radiological safety authorization for the product within a maximum of six months from its entry into the country, failing which the product shall be returned to the manufacturer or scrapped;
c) temporary import for exhibitions, fairs, special examinations or testing under the conditions imposed by the Commission, or temporary use by an authorized user;
d) unsealed radioactive sources used under research contracts by authorized users, if the Commission accepts the need for them and the conditions for their safe use.
FILE for the authorization of the IMPORT / EXPORT activity
1. Application;
2. Copies of the documents proving that the applicant is a legally established entity;
3. Technical documentation for authorization;
4. Copies of the authorizations or endorsements issued by other state bodies, required by law;
5. Other information deemed necessary by the applicant in support of the application;
6. Proof of payment of the fee and tariff (Regulation on fees and tariffs).
· The technical documentation for authorization required to obtain the import - export authorization must contain all the information necessary to demonstrate compliance with the provisions of the applicable specific regulations and to allow the assessment of the degree to which radiological safety is achieved. The information shall cover, as applicable, at least the following:
· the sources and radiological installations, specifying the type, model, components, trade name, manufacturer and quantity;
· the number of shipments and the consignors, the types of transport containers, the company, the means of transport and the routes;
· the customs and border points in the country;
· the final consignees;
· the administrative unit responsible for import – export;
· the person responsible for import – export, and that person's general and specialized training;
· the import – export procedures, which must also clarify how situations in which the product cannot be delivered to the declared beneficiary are to be resolved;
· the time interval planned for each shipment
4. Leasing authorization
The leasing authorization is issued for each radiological installation, stating the legally established entity that is the lessee, and only for the purpose of its use.
The owner is obliged to hand over the installation in good working order and with all the related technical documentation only to a legally established entity that is the lessee and holds a lawful authorization for use.
Upon expiry of the authorization, the legally established entity that is the lessee must hand the radiological installation back to the owner, including the related technical documentation, if the leasing has not been re-authorized.
Leasing is permitted only for radiological installations for which their owner holds a valid possession authorization.
FILE for the authorization of the TRANSFER or LEASING activity
1. Application;
2. Copies of the documents proving that the applicant is a legally established entity;
3. Technical documentation for authorization;
4. Copies of the authorizations or endorsements issued by other state bodies, required by law;
5. Other information deemed necessary by the applicant in support of the application;
6. Proof of payment of the fee and tariff (Regulation on fees and tariffs).
· The technical documentation for authorization required to obtain the transfer or leasing authorization must contain, as applicable, at least the following information:
· the sources and radiological installations, specifying the type, model, components, trade name, manufacturer, quantity, and the serial and manufacturing number;
· the identity of the party to which they are leased or, as applicable, of the party to which they are transferred;
· copies of the most recent verification tests;
· the administrative unit responsible for these operations;
· the responsible person, and that person's general and specialized training;
· in the case of the leasing activity, a copy of the lease contract;
· the time interval within which the operations are carried out.
5. Supply authorization
The supply authorization permits the holder to procure from domestic manufacturers or from importers, to possess and to supply the radiological installations or radiation sources stated in the authorization.
Supply is permitted only to beneficiaries that directly use the respective radiological installations or radiation sources, or to manufacturers for which they constitute the raw material.
Supply is permitted only to beneficiaries that provide proof that they fall within the authorization system.
The supply authorization is issued for distinct classes of radiological installations or radiation sources to applicants that meet at least the following conditions:
a) they have an appropriate storage space;
b) they are able to repackage damaged packages;
c) they have qualified personnel;
d) they are able to ensure specialized transport;
e) they keep strict records of deliveries;
f) they ensure the possibility of returning disused radioactive sources to the manufacturer.
FILE for the authorization of the SUPPLY activity
1. Application;
2. Copies of the documents proving that the applicant is a legally established entity;
3. Technical documentation for authorization;
4. Copies of the authorizations or endorsements issued by other state bodies, required by law;
5. Other information deemed necessary by the applicant in support of the application;
6. Proof of payment of the fee and tariff (Regulation on fees and tariffs).
· The technical documentation for authorization required to obtain the supply authorization must contain, as applicable, at least the following information:
· the sources and radiological installations, specifying the type, model, components, trade name, manufacturer and importer;
· the administrative unit responsible for these operations;
· the responsible person, and that person's general and specialized training;
· the procedures under which the activity is carried out.
6. Transfer authorization
The transfer authorization is issued for each radiological installation or class of installations and radiation sources owned by the authorization holder.
Transfer is authorized only to beneficiaries that are authorized to use the radiological installations or radiation sources subject to the transfer.
The transfer of radiological installations that are defective or lack the related technical documentation is prohibited.
The following are not considered transfers and do not need to be authorized:
a) the relocation of radiological installations or radiation sources between the administrative units of the same legally established entity;
b) handing over as radioactive waste to the organizations specialized in the collection and treatment of radioactive waste;
c) temporary dispatch to an authorized workshop for repair or testing;
d) following the division of a legally established entity, where, in the legal instruments of division, the radiological installation or the radiation sources, including the related facilities, are recorded among the assets of the new legally established entities resulting from the division.
FILE for the authorization of the TRANSFER or LEASING activity
1. Application;
2. Copies of the documents proving that the applicant is a legally established entity;
3. Technical documentation for authorization;
4. Copies of the authorizations or endorsements issued by other state bodies, required by law;
5. Other information deemed necessary by the applicant in support of the application;
6. Proof of payment of the fee and tariff (Regulation on fees and tariffs).
· The technical documentation for authorization required to obtain the transfer or leasing authorization must contain, as applicable, at least the following information:
· the sources and radiological installations, specifying the type, model, components, trade name, manufacturer, quantity, and the serial and manufacturing number;
· the identity of the party to which they are leased or, as applicable, of the party to which they are transferred;
· copies of the most recent verification tests;
· the administrative unit responsible for these operations;
· the responsible person, and that person's general and specialized training;
· in the case of the leasing activity, a copy of the lease contract;
· the time interval within which the operations are carried out.
7. Transport or transit authorization
Transport or transit authorizations are issued in accordance with the provisions of the specific norms for the transport of radioactive materials.
For practices that involve the use of mobile laboratories or transport on public roads in order to carry out the practice, the authorization of the transport is included in the authorization of the practice.
The motor vehicle used must obtain the radiological safety authorization for the product and must be used exclusively for carrying out the authorized practice.
Compliance with the provisions of the Fundamental Norms for the Safe Transport of Radioactive Materials shall also be demonstrated.
FILE for the authorization of the TRANSPORT activity
1. Application;
2. Copies of the documents proving that the applicant is a legally established entity;
3. Technical documentation for authorization;
4. Copies of the authorizations or endorsements issued by other state bodies, required by law;
5. Other information deemed necessary by the applicant in support of the application;
6. Proof of payment of the fee and tariff (Regulation on fees and tariffs).
· The technical documentation for authorization required to obtain the transit or transport authorization must contain the information necessary to prove compliance with the provisions of the specific transport norms.
· Where mobile laboratories are used or transport takes place on public roads in order to carry out the practice, the technical documentation for authorization must contain at least the following information:
· the identification data of the means of transport;
· a description of the special adaptations made to the means of transport;
· a description of the activities that require the transport of radioactive sources;
· the persons responsible for the transport, and their general and specialized training;
· the transport procedure, including the handling of emergencies.
8. Possession authorization
The possession authorization is issued for radiological installations or radiation sources that are owned by the applicant, if the applicant meets at least the following conditions:
a) it has storage conditions that ensure physical security and radiological safety;
b) it provides guarantees that the radiation sources will be used, transferred or handed over as waste in accordance with the legal provisions within a reasonable time, but no longer than two years;
c) the radiological installations or radiation sources hold a radiological safety authorization for the product and were obtained by lawful means.
Applying for a possession authorization is mandatory for radiological installations or radiation sources that are the subject of a dispute or for which the legal authorization has expired, and the authorization is issued only after their legal status within the meaning of Law no. 111/1996 has been clarified, by a decision of the competent bodies or by payment of the fine imposed by the Commission.
FILE for the authorization of the POSSESSION activity
1. Application;
2. Copies of the documents proving that the applicant is a legally established entity;
3. Technical documentation for authorization;
4. Copies of the authorizations or endorsements issued by other state bodies, required by law;
5. Other information deemed necessary by the applicant in support of the application;
6. Proof of payment of the fee and tariff (Regulation on fees and tariffs).
· The technical documentation for authorization required to obtain the possession authorization must contain at least the following information:
· The sources and radiological installations, specifying the type, model, components, trade name, manufacturer or importer, maximum parameters and identification data;
· The manner of keeping them under conditions of physical security and radiological safety;
· The reasons for possession.
9. Authorization for use - operation and/or for practices
Practices involving the use of radiological installations and/or radiation sources are authorized by implementation stages, as applicable, namely:
a) siting;
b) construction, including assembly;
c) operation - use, including maintenance;
d) preservation;
e) decommissioning.
The implementation stages may be merged, or some of these stages may not be necessary for certain practices.
For the stage of use of a radiological installation, a partial authorization, for trial operation, may be issued under the conditions of Article 8, points 7 and 8 of Law no. 111/1996, for a period of no more than two years.
This type of authorization is issued only in cases where the Commission considers that additional information on the in-service behaviour of the installation is necessary or that measurements are necessary which can only be performed over a longer period of time.
Authorization by implementation stages is mandatory for the following practices:
a) medical fluoroscopy and radiography, except dental;
b) industrial radiography;
c) radiotherapy;
d) nuclear medicine - in vivo and therapy;
e) practices involving the use of unsealed radiation sources whose activity exceeds by at least 1000 times the exemption limit in Table 2-B, Annex no. 2 to the Fundamental Norms on Radiological Safety;
f) practices involving the use of installations equipped with sealed gamma radiation sources with an activity greater than 37 GBq or with neutron sources used for activation;
g) practices involving the use of accelerators.
Where the facilities are set up in existing buildings, the siting stage and the construction stage may be merged.
FILE for the authorization of the SITING-CONSTRUCTION activity
1. Application;
2. Copies of the documents proving that the applicant is a legally established entity;
3. Technical documentation for authorization;
4. Copies of the authorizations or endorsements issued by other state bodies, required by law;
5. Other information deemed necessary by the applicant in support of the application;
6. Proof of payment of the fee and tariff (Regulation on fees and tariffs).
Technical documentation for the authorization of the siting-construction activity
· The technical documentation for authorization required to obtain the authorization must contain all the information necessary to demonstrate compliance with the provisions of the applicable specific regulations and to allow the assessment of the degree to which radiological safety is achieved. The information shall cover, as applicable, at least the following:
· A description of the radiation sources and radiological installations;
· A description of the premises and buildings used;
· The dose limitation programme and the applicable constraints, the ALARA principle;
· The classification of workplaces into controlled areas and supervised areas, the site plans;
· The individual and collective radiation protection equipment;
· The impact on the public and the environment;
· Potential exposures and the countermeasures;
· The documentation shall contain the statement of expert review and acceptance thereof, signed by the radiation protection expert named in the application.
· The statements in the technical documentation shall be supported by copies of the supporting deeds and documents.
· The sketches or plans must be drawn up in accordance with the technical prescriptions in the field, be legible and be signed by the person who drew them up. The siting plans must be correlated with the accompanying descriptive text and be sufficiently detailed to allow verification that the prescriptions of the specific regulations are met.
· The technical documentation for siting must clarify the impact on the environment and on other human activities in the area, both for normal operation and in the event of potential exposures.
· The technical documentation for construction must present the solutions adopted to achieve the level of radiological safety proposed in the previous stage, including substantiation by means of calculations and specific design materials.
FILE for the authorization of the USE activity
1. Application;
2. Copies of the documents proving that the applicant is a legally established entity;
3. Technical documentation for authorization;
4. Copies of the authorizations or endorsements issued by other state bodies, required by law;
5. Other information deemed necessary by the applicant in support of the application;
6. Proof of payment of the fee and tariff (Regulation on fees and tariffs).
· The technical documentation for authorization required to obtain the radiological safety authorization for practices or for the use of radiological installations and/or radiation sources must contain all the information necessary to demonstrate compliance with the provisions of the applicable specific regulations and to allow the assessment of the degree to which radiological safety is achieved. The information shall cover, as applicable, at least the following:
· The justification, optimization and description of the practice;
· A description of the radiation sources and radiological installations;
· The management of radioactive waste and the release of radioactive effluents;
· A description of the premises and buildings used;
· The dose limitation programme and the applicable constraints, the ALARA principle;
· The classification of workplaces into controlled areas and supervised areas, the site plans;
· The classification of occupationally exposed workers into categories;
· Dose assessment, the monitoring system, the accredited dosimetry body;
· The training and authorization of personnel;
· The individual and collective radiation protection equipment;
· The radiological safety officers by area and the radiation protection experts;
· The impact on the public and the environment;
· Preservation and decommissioning;
· Potential exposures and the countermeasures;
· The internal documents governing the practice, including those of the quality system.
· The documentation shall contain the statement of expert review and acceptance thereof, signed by the radiation protection expert named in the application.
· The statements in the technical documentation shall be supported by copies of the supporting deeds and documents.
· The sketches or plans must be drawn up in accordance with the technical prescriptions in the field, be legible and be signed by the person who drew them up. The siting – assembly – installation plans must be correlated with the accompanying descriptive text and be sufficiently detailed to allow verification that the prescriptions of the specific regulations are met.
· For practices that are authorized in stages, the technical documentation must contain the relevant information for each stage. The documentation for the subsequent stage shall also demonstrate that the objectives of the previous stage have been achieved.
· The technical documentation for siting must clarify the impact on the environment and on other human activities in the area, both for normal operation and in the event of potential exposures.
· The technical documentation for construction must present the solutions adopted to achieve the level of radiological safety proposed in the previous stage, including substantiation by means of calculations and specific design materials.
FILE for the authorization of the DECOMMISSIONING activity
1. Application;
2. Copies of the documents proving that the applicant is a legally established entity;
3. Technical documentation for authorization;
4. Copies of the authorizations or endorsements issued by other state bodies, required by law;
5. Other information deemed necessary by the applicant in support of the application;
6. Proof of payment of the fee and tariff (Regulation on fees and tariffs).
· The technical documentation for authorization required to obtain the decommissioning authorization must contain at least the following information:
· a description of the installation subject to decommissioning;
· a description of the decommissioning process, with emphasis on decontamination, the optimization of radiation protection and the application of the ALARA principle;
· a presentation of the management of the resulting radioactive waste;
· the working procedures of the organization carrying out the decommissioning.
10. Construction authorization
The construction authorization permits the execution of the necessary construction and fitting-out works, the assembly of the radiological installations and their operation for a limited time solely in order to allow their adjustment and the performance of the acceptance tests and of the tests of the effectiveness of the protective shielding.
For practices that are authorized in a single stage, the assembly of the radiological installations and the performance of the acceptance tests and of the tests of the effectiveness of the protective shielding are permitted only if the beneficiary has notified the Commission of the intention to use these installations and provides proof of that notification.
The installer is obliged to take the necessary measures so that the radiological installation may be used by the beneficiary only after the authorization for use has been obtained.
FILE for the authorization of the SITING-CONSTRUCTION activity
1. Application;
2. Copies of the documents proving that the applicant is a legally established entity;
3. Technical documentation for authorization;
4. Copies of the authorizations or endorsements issued by other state bodies, required by law;
5. Other information deemed necessary by the applicant in support of the application;
6. Proof of payment of the fee and tariff (Regulation on fees and tariffs).
Technical documentation for the authorization of the siting-construction activity
· The technical documentation for authorization required to obtain the authorization must contain all the information necessary to demonstrate compliance with the provisions of the applicable specific regulations and to allow the assessment of the degree to which radiological safety is achieved. The information shall cover, as applicable, at least the following:
· A description of the radiation sources and radiological installations;
· A description of the premises and buildings used;
· The dose limitation programme and the applicable constraints, the ALARA principle;
· The classification of workplaces into controlled areas and supervised areas, the site plans;
· The individual and collective radiation protection equipment;
· The impact on the public and the environment;
· Potential exposures and the countermeasures;
· The documentation shall contain the statement of expert review and acceptance thereof, signed by the radiation protection expert named in the application.
· The statements in the technical documentation shall be supported by copies of the supporting deeds and documents.
· The sketches or plans must be drawn up in accordance with the technical prescriptions in the field, be legible and be signed by the person who drew them up. The siting plans must be correlated with the accompanying descriptive text and be sufficiently detailed to allow verification that the prescriptions of the specific regulations are met.
· The technical documentation for siting must clarify the impact on the environment and on other human activities in the area, both for normal operation and in the event of potential exposures.
· The technical documentation for construction must present the solutions adopted to achieve the level of radiological safety proposed in the previous stage, including substantiation by means of calculations and specific design materials.
11. Decommissioning authorization
The decommissioning authorization permits the dismantling of the radiological installations and the demolition of the related structures through an organization holding an appropriate handling authorization.
For the installations mentioned in Article 39(4) of the Radiological Safety Norms – Authorization Procedures, for which a decommissioning authorization is not required, decommissioning must be carried out through an organization holding an appropriate handling authorization.
FILE for the authorization of the DECOMMISSIONING activity
1. Application;
2. Copies of the documents proving that the applicant is a legally established entity;
3. Technical documentation for authorization;
4. Copies of the authorizations or endorsements issued by other state bodies, required by law;
5. Other information deemed necessary by the applicant in support of the application;
6. Proof of payment of the fee and tariff (Regulation on fees and tariffs).
· The technical documentation for authorization required to obtain the decommissioning authorization must contain at least the following information:
· a description of the installation subject to decommissioning;
· a description of the decommissioning process, with emphasis on decontamination, the optimization of radiation protection and the application of the ALARA principle;
· a presentation of the management of the resulting radioactive waste;
· the working procedures of the organization carrying out the decommissioning.
12. Handling authorization
The handling authorization is issued in a single stage.
The activities permitted within the authorized handling practice are stated in the annex to the authorization. These may be one or more of the following: assembly, installation, maintenance, repair, verification, modification, reconditioning, dismantling, treatment, processing or any other operation that falls within the definition.
It is prohibited to carry out activities within the handling practice at beneficiaries that are not authorized in accordance with Law no. 111/1996, or for radiological installations and radiation sources without a radiological safety authorization for the product.
The authorization holder may bring from beneficiaries, for a fixed period of time, to its own appropriately equipped workshops, radiological installations and radiation sources in order for them to be repaired, modified or verified, in accordance with a procedure for taking into custody approved by the Commission in the authorization process.
For as long as the radiological installations and radiation sources are in the custody of the holder of the handling authorization, the holder assumes all legal responsibilities for ensuring their physical security and radiological safety.
The use of radiological installations and radiation sources held in custody, or their transfer to third parties, is prohibited.
Radiological installations held in custody may be put into operation only for testing and verification.
In the course of the repair activity, it is prohibited to replace parts or subassemblies with ones that are not original or have not been recommended by the manufacturer, and to modify or remove the radiological safety features.
For installation – assembly activities, the beneficiary is considered to be authorized if it meets one of the following conditions:
a) for radiological installations subject to registration, the beneficiary provides proof that they were lawfully purchased and the installations hold a radiological safety authorization for the product;
b) for radiological installations that are authorized in a single stage, the beneficiary provides proof that the Commission has been notified and the installations hold a radiological safety authorization for the product;
c) for radiological installations that are authorized in stages, the beneficiary presents a valid construction authorization issued by the Commission;
d) the radiological installations were imported pursuant to Article 27, points b) and c) of the Radiological Safety Norms – Authorization Procedures.
The installer must comply with the installation–assembly instructions supplied by the manufacturer of the installation and with the limits and conditions imposed by the authorizations issued by the Commission, must train the beneficiary's personnel in the use of the installation and must not make any modifications to it, including to the labelling system.
The installer is authorized, during the assembly period, to put the radiological installation into operation only for the time necessary for adjustment, verification and testing, in accordance with its own procedure approved by the Commission in the authorization process. Two copies of the report containing the results of the acceptance tests shall be handed over to the beneficiary.
The commissioning of the installation and its handover to the user are permitted only after the authorization for use or the registration certificate has been obtained.
FILE for the authorization of the HANDLING / PRODUCTION activity
1. Application;
2. Copies of the documents proving that the applicant is a legally established entity;
3. Technical documentation for authorization;
4. Copies of the authorizations or endorsements issued by other state bodies, required by law;
5. Other information deemed necessary by the applicant in support of the application;
6. Proof of payment of the fee and tariff (Regulation on fees and tariffs).
· The technical documentation for authorization required to obtain the handling authorization must contain at least the following information:
· the types of radiological installations;
· a demonstration of technical capability;
· the personnel with responsibilities;
· the procedures under which the activities are carried out.
· The technical documentation for authorization required to obtain the production authorization must contain at least the following information:
· a description of the production process;
· the identification of the areas and operations involving a radiation hazard;
· the treatment of the areas involving a radiation hazard in accordance with the requirements for the use of radiation sources;
· the personnel with responsibilities;
· the quality system documents or a demonstration of its certification by a notified body.
13. Production authorization
The authorization of the practice of producing radiological installations and radiation sources permits the performance of production and processing, possession, storage and supply activities.
The holder of the production authorization is obliged to obtain the radiological safety authorization for the products it wishes to manufacture.
The supply of products that have not obtained the radiological safety authorization for the product is prohibited.
The production process must be organized under a quality assurance system certified by a notified body in the nuclear field.
FILE for the authorization of the HANDLING / PRODUCTION activity
1. Application;
2. Copies of the documents proving that the applicant is a legally established entity;
3. Technical documentation for authorization;
4. Copies of the authorizations or endorsements issued by other state bodies, required by law;
5. Other information deemed necessary by the applicant in support of the application;
6. Proof of payment of the fee and tariff (Regulation on fees and tariffs).
· The technical documentation for authorization required to obtain the handling authorization must contain at least the following information:
· the types of radiological installations;
· a demonstration of technical capability;
· the personnel with responsibilities;
· the procedures under which the activities are carried out.
· The technical documentation for authorization required to obtain the production authorization must contain at least the following information:
· a description of the production process;
· the identification of the areas and operations involving a radiation hazard;
· the treatment of the areas involving a radiation hazard in accordance with the requirements for the use of radiation sources;
· the personnel with responsibilities;
· the quality system documents or a demonstration of its certification by a notified body.
- THE AUTHORIZATION FILE
The authorization or registration file shall have numbered pages and shall include a table of contents.
All documents in the authorization file must be legible and printed - typewritten or produced on a printer. Documents sent by fax are not accepted.
Where copies of supporting documents are required, these shall be photocopies or typewritten copies, authenticated or confirmed under signature by the applicant. Copies made or sent by fax are not accepted.
The authorization documents shall be submitted in a file folder with a fastener.
The information contained in the authorization or registration files is confidential. The employees of the Commission are obliged to respect its confidentiality, or the secret nature of certain information if it has been declared as such by the applicant, subject to the penalties laid down by the laws in force.
Incomplete files, within the meaning of Article 49 of the Radiological Safety Norms – Authorization Procedures, do not enter the assessment process.
The Commission shall give notice, by letter, of the necessary additions within a maximum of 30 days. If these additions are not received within no more than one month from the date of the notice, the file is rejected without any further warning and the applicant may no longer make subsequent reference to it, claim the use of parts of it or claim back the fees and tariffs paid.
Complete files, within the meaning of Article 49 of the Radiological Safety Norms – Authorization Procedures, enter the assessment process, during which the Commission may request clarifications, evidence in support of the statements made, expert reports, the reworking of parts of the file and the direct participation of the qualified person representing the applicant, and may carry out inspections and set deadlines for the completion of the additions requested. Failure to meet these deadlines without the prior consent of the Commission leads to the rejection of the application for authorization.
For practices and activities that are authorized in stages, an inspection is mandatory at the commissioning stage.
Rejected files or parts of them may not be used subsequently for other applications for authorization on the grounds that they have already been submitted to the Commission.
The use of the technical documentation in the authorization file by another importer in order to obtain a radiological safety authorization for the product is permitted only with the written consent of the legally established entity that holds the file.
The assessment process lasts no more than two months and is concluded with the issuance of the authorization or with a letter giving notice of the reasoned rejection of the authorization, duly justified, where the conditions for authorization are not met.
Incomplete or rejected files are not returned.
The second copy of the authorization or registration file is returned to the applicant together with the authorization or registration certificate issued. These files shall bear a registration number and each page of the file shall bear the stamp of the Commission.
The authorization applicant may lodge a challenge, with duly documented arguments, by means of a written submission addressed to the President of CNCAN, within two months from the date of receipt of the letter giving notice of the rejection of the authorization.
- PERIOD OF VALIDITY OF THE AUTHORIZATION AND OF THE REGISTRATION
The authorization is issued for a limited period of time, which as a rule is 5 years. The Commission may establish, on a case-by-case basis, any period of validity shorter than 5 years for certain authorizations.
Import, export, transfer and transit authorizations are issued for a period of time considered by the applicant to be sufficient for carrying out the activity, but not more than one year.
The possession authorization for radiological installations that have been taken out of use or placed in storage is issued for a period of no more than two years.
The registration is valid for as long as the conditions under which it was obtained do not change, but not more than ten years.
The registration ceases to be valid if:
a) the rated service life of the product has expired;
b) the use of the product has changed;
c) the responsible person has been changed without the consent of the Commission;
d) the legally established entity holding the registration no longer legally exists or its registration details have changed.
- EXTENSION, RE-AUTHORIZATION AND MODIFICATION OF AUTHORIZATIONS
The extension of the validity of the registration is applied for within the 30-day period preceding the expiry of the registration.
The extension of the validity of the registration is applied for by sending to the Commission the documents and information provided for in Articles 49, 57 and 58(1) and (3) of the Radiological Safety Norms – Authorization Procedures.
The copy of the acceptance tests is replaced by a copy of the most recent verification of the installation and of the most recent CNCAN inspection report, which must not be more than one year old.
Re-authorization or extension of the period of validity of the authorization
Re-authorization is necessary if:
a) the extension of the period of validity of the authorization was not applied for before its expiry;
b) it is intended to introduce new practices, radiation sources or radiological installations;
c) it is intended to modify the technical facilities or the limits in the authorization;
d) the authorization has been withdrawn by the issuer, with the right to re-authorization.
The scrapping of installations or the handing over of radioactive sources as radioactive waste does not require an application for re-authorization.
Re-authorization is applied for in accordance with the provisions of Article 49 of the Radiological Safety Norms – Authorization Procedures. It is applied for 45 days before the activities provided for in Article 79, points b, c and d of the Radiological Safety Norms – Authorization Procedures are carried out.
The extension of the period of validity of the authorization is applied for within a period of 45 days before the expiry date of the authorization. This time limit is considered to have been met if the re-authorization file has entered the assessment process, as provided for in Article 52 of the Radiological Safety Norms – Authorization Procedures, before the expiry of the authorization.
If the provisions of Article 52 are complied with, the validity of the authorization for which the extension of the period of validity is applied for is automatically extended for the duration of the assessment process, but not for more than 2 calendar months. After this period of time, if a new authorization has not been issued, the authorization holder is obliged to cease its activity and to initiate the specific procedure for the cessation of activity, in accordance with Article 100 of the Radiological Safety Norms – Authorization Procedures.
Where the authorization holder considers that the failure to issue the authorization within the time limit provided for above is attributable to the Commission and is likely to cause it damage, it may request the application of the provisions of Article 53 of Law no. 111/1996.
The extension of the period of validity of the authorization is applied for by sending to the Commission a file, with numbered pages and containing a table of contents, consisting of:
a) an application;
b) proof of payment of the fees and tariffs (Regulation on fees and tariffs);
c) the technical documentation.
The technical documentation for re-authorization or for the extension of the period of validity of the authorization shall contain at least the following information:
a) the manner in which the conditions imposed by the authorization or the instructions given in the inspection reports have been fulfilled;
b) an extract from the records of radiation sources and radiological installations reflecting the up-to-date situation; the list of dosimetric equipment;
c) the improvements regarding radiation protection and radiological safety;
d) the up-to-date list of the personnel involved in the authorized activities, stating their qualifications;
e) copies of the most recent verification tests of the radiation sources or radiological installations;
f) the reporting of any events that merit analysis from the point of view of radiological safety.
The authorization may be modified:
a) by the Commission, on its own initiative, in accordance with the provisions of Article 13 of Law no. 111/1996;
b) at the request of the authorization holder.
The authorization holder is obliged to apply for the modification of the authorization in the following situations:
a) a change of name, a change of the company's registered office or other amendments to the company's articles of association that alter the information on which the issuance of the authorization was based;
b) a change of the personnel with responsibilities in the field of radiological safety;
c) modifications of the limits and conditions specified in the authorization;
d) other modifications that could affect the safety of the radiation sources or the radiation protection of exposed personnel, of the public or of the environment.
Modifications are applied for by sending to the Commission a modification file, with numbered pages and containing a table of contents, consisting of:
a) an application;
b) proof of payment of the fees and tariffs (Regulation on fees and tariffs);
c) documentation supporting the need for the modifications requested.
The modification of the authorization does not change its period of validity. If the Commission finds that the modifications made or proposed do not satisfy the radiological safety requirements, it shall withdraw the authorization or prohibit the modifications from being made.
- SANCTIONS REGIME
Suspension of the authorization and withdrawal of the authorization and of the registration
The authorization is suspended or withdrawn, in part or in full, and the registration is withdrawn, by the issuer, on its own initiative or upon a complaint from any natural or legal person, in all cases where the Commission finds that the conditions mentioned in Article 11 of Law no. 111/1996 are met.
The measure of suspension or withdrawal of the authorization is notified to the authorization holder by a letter signed by the President of the Commission. The notification shall state the legal basis and the reasons that led to this measure being taken. In the case of suspension, the period of suspension shall also be stated.
The suspension and the withdrawal of the authorization take effect as soon as they have been brought to the attention of the legally established entity. Signing for receipt of the correspondence constitutes proof that it has been informed.
The suspension of the authorization has the following effects:
a) the immediate cessation of the activities in the nuclear field;
b) the obligation of the holder to take measures to ensure the physical security and radiological safety of the radiation sources and radiological installations;
c) the obligation of the holder to submit, within a maximum of 5 working days, a plan of measures, with completion deadlines and responsible persons, for resolving the problems that gave rise to the suspension measure;
d) the obligation of the holder to return the original of the authorization to the Commission immediately.
The suspension measure is taken in cases which are considered capable of being resolved within a period of time not exceeding 4 calendar months. If this requirement cannot be met, the measure of withdrawal of the authorization is taken.
The suspension is lifted by notifying the holder on the basis of an inspection report in which it was found that all the reasons underlying the suspension measure have been removed.
The lifting of the suspension takes effect from the moment of receipt of the notification signed by the President of the Commission and of the original of the authorization.
The withdrawal of the authorization has the following effects:
a) the immediate cessation of the activities in the nuclear field;
b) the obligation of the holder to take measures to ensure the physical security and radiological safety of the radiation sources and radiological installations;
c) the obligation of the holder to return the original of the authorization to the Commission immediately;
d) the immediate commencement of the procedure for the cessation of activity in accordance with Article 28 of Law no. 111/1996.
Loss, theft or damage of the authorization or registration certificate
In the event of loss, theft or damage of the authorization or registration certificate, the authorization holder must apply for a duplicate, which is issued under the following conditions:
a) an application explaining the circumstances in which the event occurred;
b) proof of publication of a notice of cancellation of the authorization;
c) proof of payment of the tariff provided for the modification of the authorization
Loss of validity of the authorization
The authorization ceases to be valid in the following cases:
a) the period of validity stated on the authorization has been exceeded, subject to the exception provided for in Article 82 of the Radiological Safety Norms – Authorization Procedures;
b) the authorization holder has lost its status as a legally established entity;
c) the holder relinquishes the authorization, having fulfilled the conditions for the cessation of activity;
d) the authorized activity or practice has been abandoned or transferred to another party;
e) the authorizations have been withdrawn, cancelled or suspended.
- CESSATION OF ACTIVITY
Cessation of activity
Upon cessation of activity, the authorization holder is obliged to:
a) draw up and implement an authorized decommissioning plan, where applicable;
b) transfer the sources to authorized users, on the basis of a specific authorization, or treat them as radioactive waste;
c) transfer the radioactive waste to a treatment facility;
d) decontaminate the premises and equipment it has used, where applicable, down to the exemption limit.
The cessation of activity takes effect only after CNCAN has registered the letter giving notice of the cessation of activity, accompanied by the supporting documents, and, at least in cases where unsealed sources or sources presenting a contamination hazard were used, after the working area has been inspected by an authorized representative of the Commission.
The cessation of activity is notified using form no. 6 or form no. 7, as applicable, in Annex no. 1 to the Radiological Safety Norms – Authorization Procedures.
The Commission is obliged to keep the cessation of activity file for a period of 10 years.