A. Graded approach to regulatory control
Based on
the Protection against Ionising Radiation and Nuclear and Radiological Safety and Security Law of 2018, all practices, sources and installations falling within the scope of the Law are subject to regulatory control for the purpose of radiation protection and radiological or nuclear safety and security, by way of
notification or
authorisation, and appropriate
inspections and, where necessary,
enforcement actions.
B1. Notification
The
notification to the Radiation Inspection and Control Service (RICS) for the commence of a practice that falls within the scope of application of the Law is the first level of regulatory control in the implementation of a graded approach. The
notification shall be made to RICS
prior to the practice commencing. Any commence of such a practice without it being notified to RICS is an offense under the above Law and is subject to appropriate enforcement actions.
For practices subject to notification, RICS has determined the format of the notification and the information to be provided with this notification.
The notification form submitted to RICS is available under the Forms and Applications section. Notifications not submitted using this form will not be considered.
The practices for which a notification is required, the procedures applied and the requirements and supporting documents to be submitted with the notification are set out in the Notification of the Chief Inspector titled “The Protection against Ionising Radiation and Nuclear and Radiological Safety and Security (Specifications for practices, procedures and requirements of regulatory control relating to the notification or the granting of authorization through registration or licensing) Notification of 2019” (R.A.A. 153/2019), which was published in the Official Gazette of the Republic on 10 May 2019, pursuant to article 63 of the Protection against Ionising Radiation and Nuclear and Radiological Safety and Security Law of 2018, pursuant to sections 13 and 14 of this Law.
B2. Practices subject to notification
In summary, the practices subject to notification are as follows:
1. Practices in workplaces where the average annual radon concentration continues to exceed the national reference level of 300 Bq m-3 as an annual average, as defined in the Regulations, despite the action taken in accordance with the principle of optimisation referred to in section 10(2) of the Law and described in the Regulations
2. Existing exposure situations which are of concern from a radiation protection point of view, for which legal responsibility can be assigned in accordance with section 57(3) of the Law and which are managed as planned exposure situations
3. Practices identified in accordance with section 19 of the Law which, notwithstanding the exemption criteria laid down in section 16 of the Law, may lead to the presence of naturally-occurring radionuclides in water liable to affect the quality of drinking water or other exposure pathways, so as to be of concern from a radiation protection point of view
4. Practices involving naturally occurring radioactive materials, the activity concentration of which is up to 10 times greater than the values laid down in the Law (Third Schedule, Part II, Section B)
5. Human activities involving radioactively contaminated materials which do not fall under authorised releases or materials cleared in accordance with section 18 of the Law which must therefore be managed as planned exposure situations:
- recycling of residues from industries processing naturally occurring radioactive material into building materials
- disposal, recycling, or reuse of naturally occurring radioactive materials arising from any activity that falls under the provisions of section 19 of the Law
6. Transport of:
- excepted packages of radioactive material (UN 2908, UN 2909, UN 2910, UN 2911 and UN 3507)
- low specific activity radioactive material (LSA I, LSA II and LSA III) which are not fissile, or which are fissile-excepted (UN 2912, UN 3321 and UN 3322)
- surface contaminated objects where the radioactive material is not fissile or is fissile-excepted (SCO I, SCO 2) (UN 2913)
as defined:
- regarding the definition and description of radioactive materials: by the International Atomic Energy Agency in the Standard Series “IAEA Safety Standards for protecting people and the environment, Specific Safety Requirements No SSR 6 (Rev. 1): Regulations for the Safe Transport of Radioactive Material (2018 Edition)”
- regarding the categorisation of the materials or packages containing radioactive materials: by the UN in the “Recommendations on the Transport of Dangerous Goods, Model Regulations, Volume I, Nineteenth revised edition, United Nations, New York and Geneva, 2015”
or the amended or new versions thereof.
C1. Authorisation (through registration or licensing)
Notified practices which are not exempted from authorisation are subject to regulatory control through registration or licensing.
Where an application for an authorisation is submitted, no separate notification is needed.
RICS is responsible for determining the procedures and requirements for authorisation by way of registration or licensing for sources of, and practices involving, ionising radiation.
The practices that are subject to authorisation through registration or authorisation through licensing, as well as the procedures to be followed and the requirements and supporting documents required for granting an authorisation through registration or licensing for sources of, and practices involving, ionising radiation, are also set out in the Notification of the Chief Inspector titled “The Protection against Ionising Radiation and Nuclear and Radiological Safety and Security (Specifications for practices, procedures and requirements of regulatory control relating to the notification or the granting of authorization through registration or licensing) Notification of 2019” (R.A.A. 153/2019).
Authorisation through registration or licensing is granted to the undertaking by RICS at a written request of the undertaking to RICS which, in the case of authorisation through licensing, is subject to, or may be subject to, terms, requirements and conditions (section 20 of the Law).
Any undertaking requesting authorisation through licensing is required to demonstrate and substantiate adequately that it ensures adequate levels of nuclear or radiological safety and security and radiation protection in its installation and during the conduct of any practice.
For the practices for which authorisation is required, RICS has determined the format of the authorisation and the information to be provided with the application for authorisation.
The authorisation form submitted to the RICS is available under the Forms and Applications section. Applications not submitted using this form will not be considered.
Part III (“Procedures concerning Authorisation”) of Chapter ΙV (“Prohibition and Regulatory Control of Practices”) of the Law refers to procedures relating to authorisations, including the terms, requirements, and conditions for authorisation through licensing.
Except where authorisations are granted for the transport, import, export, shipment or supply of radioactive sources or radiation generators or accelerators, before setting, modifying, preparing or taking a decision on terms, requirements and conditions in relation to the granting of authorisation through licensing, RICS consults the Technical Licensing Committee provided for in the Law.
The competent authority may set fees for various offered services (including the above services) and the undertaking, employer, person, or other body is required to pay these fees in advance within a specified period.
C2. Practices subject to authorization through registration
1. Practices using radiation generators for dental applications and measuring bone mass
2. Practices using radiation generators for non-medical imaging purposes which operate at a potential difference of less than 200 kV, excluding computerised tomography (CT) practices
3. Practices using unsealed radioactive sources with a maximum total annual activity concentration of 100 MBq for the purpose of in vitro medical or non-medical applications
4. Practices using Category 5 sealed radioactive sources (see International Atomic Energy Agency Safety Standard Series RS G 1.9 “Categorisation of Radioactive Sources”, Vienna, 2005, as amended or replaced)
5. Practices which include natural radioactive materials, the activity concentration of which is at least 10 times greater than the values laid down in the Law (Third Schedule, Part II, Section B)
6. Import, export, supply, transport and any other practice using radiation generators for medical or non-medical exposures, whatever the potential difference applied, which is carried out before the stage at which the generator is installed and put into operation such that it may result in exposure
7. Transport of:
- radioactive material in Type A packages (whether it is fissile or fissile-excepted) (UN 2915, UN 3327, UN 3332 and UN 3333)
- radioactive material of low specific activity (LSA-II and LSA-III) which is fissile (UN 3324 and UN 3325)
- objects surface contaminated with radioactive material which is fissile (SCO 1 or SCO 2) (UN 3326),
as defined:
- regarding the definition and description of radioactive materials: by the International Atomic Energy Agency in the Standard Series ‘IAEA Safety Standards for protecting people and the environment, Specific Safety Requirements No SSR 6 (Rev. 1): Regulations for the Safe Transport of Radioactive Material (2018 Edition)’;
- regarding categorisation of the materials or packages containing radioactive materials: by the UN in the ‘Recommendations on the Transport of Dangerous Goods, Model Regulations, Volume I, Nineteenth revised edition, United Nations, New York and Geneva, 2015’,
or the amended or new versions thereof.
C3. General Conditions concerning the granting of approvals through registration
The competent authority has issued General Conditions concerning the practices subject to, and for which it grants, authorisations through registration. These General Conditions are:
C4. Practices subject to authorization through licensing
1. The deliberate administration of radioactive substances to persons and, in so far as the radiation protection of human beings is concerned, animals for the purpose of medical or veterinary diagnosis, treatment or research
2. The operation and decommissioning of any nuclear facility and the exploitation and closure of uranium mines
3. The deliberate addition of radioactive substances in the production or manufacture of consumer products or other products, including medicinal products (radiopharmaceutical products), and the import or export of such products
4. Practices involving high-activity sealed sources
5. The operation, decommissioning and closure of any facility for the long-term storage or disposal of radioactive waste, including facilities managing radioactive waste for this purpose
6. Practices resulting in the discharge of significant amounts of radioactive material with airborne or liquid effluent into the environment
7. Practices using radiation generators for medical exposures other than those specified in paragraph 1 of the Second Schedule in the Notification R.A.A. 153/2019
8. Practices using radiation generators for non-medical imaging purposes other than those specified in paragraph 2 of the Second Schedule in the Notification R.A.A. 153/2019, i.e. which operate at a potential difference more than 200 kV, including computerised tomography (CT) practices
9. Practices using all manner of accelerators for medical exposures or for non-medical imaging purposes except electronic microscopes
10. Practices using sealed or unsealed radioactive sources other than those specified in paragraphs 3 and 4 of the Second Schedule in the Notification R.A.A. 153/2019, provided that those radioactive sources include all manner of nuclear fissile material
11. Transport of:
- Radioactive sources that fall under the types of practices listed in paragraph 4 of Part I of the Third Schedule of the Notification R.A.A. 153/2019
- Radioactive materials or packages of any type other than Type A (Type B(U), B(M) or C) (UN 2916, UN 3328, UN 2917, UN 3329, UN 3323 and UN 3330)
- Radioactive materials subject to special arrangement (UN 2919 and UN 3331)
- Uranium hexafluoride (UN 2977, UN 2978 and UN 3507)
as defined:
- with regard to the definition and description of radioactive materials: by the International Atomic Energy Agency in the Standard Series “IAEA Safety Standards for protecting people and the environment, Specific Safety Requirements No SSR 6 (Rev. 1): Regulations for the Safe Transport of Radioactive Material (2018 Edition)”
- with regard to categorisation of the materials or packages containing radioactive materials: by the UN in the “Recommendations on the Transport of Dangerous Goods, Model Regulations, Volume I, Nineteenth revised edition, United Nations, New York and Geneva, 2015”
or the amended or new versions thereof.
D. Special requirements, standards and specifications for practices that fall within the scope of the Law
The competent authority has issued a series of Regulatory Administrative Acts (special requirements, standards, specifications and codes of practice) in the form of Notifications in the Official Gazette of the Republic. These Notifications cover issues such as:
- Education and Training in Radiation Protection and Nuclear and Radiological Safety and Security
- Control and Recovery of Orphan Radioactive Sources and Emergency Response due to Orphan Sources
- Radiation Protection of the Members of the Public
- Classification of Controlled and Supervised Areas
- Role, Responsibilities and Practices as regards appointment of a Radiation Protection Officer
- Definition and Application of Diagnostic Reference Levels for Radiodiagnostic Examinations
- Individual Radiological Monitoring
- Implementation of a Management System by the Undertaking or the Employer
- Conducting a Risk Assessment
- Application of Local Rules, Supervision of Classified Areas and Application of Additional Requirements for Classified Areas
- Safety and Security in Transport of Radioactive Materials.
The texts of these Notifications are available in the path Legislation >
Regulations.
DEPARTMENT OF LABOUR INSPECTION
Last update 19.7.2023