1. On 5 December 2024, Royal Decree 1217/2024, of 3 December, approving the Regulation on nuclear and radioactive facilities and other activities related to exposure to ionising radiation (vid. BOE-A-2024-25205 ) entered into force, with the aim of completing the transposition of the Council Directive 2013/59/Euratom of 5 December 2013.
2. Content: The Regulation covers from nuclear and radioactive installations to occupational activities with exposure to natural and cosmic radiation sources (introduction of clear limits, such as 300 Bq/m³ for radon concentration).
3. Focusing on radioactive facilities, they are defined (insofar as their classification as nuclear facilities is not appropriate) as: (a) facilities of any kind where radioactive materials are produced, used, possessed, handled, processed, handled or stored for the purpose of exploiting their radioactive, fissile or fertile properties, except incidental storage during transport; and (b) ionising radiation generating equipment operating or accelerating electrical charges with a potential difference of more than 5 kV.
4. Depending on their hazard, they are classified into: (a) 1st Category: Uranium plants, industrial irradiation and large quantities of radioactive substances; (b) 2nd Category: Facilities with radionuclides ≥1,000 times the exemption values, X-rays >200 kV, and accelerators >1 MeV; and (c) 3rd Category: Radionuclides between the exemption values and 1,000 times those values, X-rays ≤200 kV and accelerators ≤1 MeV.
5. Competent authorities: Application of the regulation falls to the Ministry for Ecological Transition and Demographic Challenge (MITECO), the Nuclear Safety Council (CSN) and the autonomous communities with transferred competences, without prejudice to the attributions of other ministries and public administrations. The Autonomous Communities, after assuming the functions by means of transfer, will manage 2nd and 3rd category radioactive facilities. The operating permits for these facilities are valid throughout the national territory, but the licensee must communicate its activity prior to initiating operations.
Furthermore, the public administrations may not refuse or condition authorisations for reasons of nuclear safety or radiation protection, since these assessments are exclusive to the CSN.
6. Regarding the radioactive nuclear fuel cycle facilities (uranium concentrate production plants, including those areas of the site where the disposal of radioactive waste generated therein is carried out):
a) Decommissioning and closure authorisation and closure statement and, where applicable, modification authorisation and authorisation for change of ownership may be requested.
b) Facilities declared closed are included in an official register managed by the Directorate General for Energy Planning and Coordination (DGPCE), which documents their location, inventory and characteristics of the waste stored.
c) They will be staffed by operating personnel holding a specific CSN licence.
d) They will have a Radiation Protection Service, for which a person accredited for this purpose with a diploma as Head of Radiation Protection Service issued by the CSN will be responsible.
7. Regarding separate radioactive facilities:
a) They require an operating authorisation, a declaration of closure and, where applicable, authorisation for modification and authorisation for change of ownership.
b) All authorised 2nd and 3rd category radioactive installations will be included in the Register of Radioactive Installations attached to the DGPCE.
c) Subject to certain exceptions, personnel handling radioactive material or equipment generating ionising radiations and personnel directing such activities must hold a specific licence issued by the CSN.
8. The holder of an authorisation is responsible for ensuring the safe operation of the installation in accordance with the regulations, keeping documentation up to date and informing the authorities of matters that may affect nuclear or radiological safety, as well as managing emergency situations.
9. The licensee must also implement systems for internal and external staff to report deficiencies that compromise safety, as well as the obligation to keep detailed records and submit annual reports.
10. The regulation also establishes the need for mandatory training programmes for all exposed personnel.
11. It is not permitted to operate, transport or admit nuclear material without liability cover for possible damage.
12. The licensee of high activity encapsulated sources is required to register each source under his responsibility in the Register maintained by the CSN. Furthermore, the licensee is obliged to perform annual and post-incident tests to guarantee tightness and to verify the status of the source and associated equipment on a monthly basis.
13. Furthermore, it is important to note that solid waste materials with radioactive contents generated in the practices may be declassified for management by conventional means and not as radioactive waste, subject to authorisation by the DGPCE, following a report by the CSN.
14. Deadline for adaptation: Operators with authorisations in force or granted after 5 December 2024, but initiated under previous regulations, have until 5 June 2025 to submit the necessary applications to the DGPCE and comply with the new requirements of the Regulation. Likewise, operators of installations which category is modified by the Regulation must adapt their situation with MITECO before 5 June 2025.