To further the implementing of a graded approach in the oversight of the nuclear activities coming under the Public Health Code, ASN continued working on the update of the abovementioned resolution. A first step will be completed at the beginning of 2025, with the on-line availability of the new application form for authorisation to possess and use sealed radioactive sources. This update will complete the work started in 2018 which has already led to revising of the notification system and creation of the registration system (see next page). The notification system As part of the overhaul of the classification of nuclear activities into the three administrative systems introduced by the abovementioned Decree of 4 June 2018, ASN decided to implement a more graded approach, proportionate to the risks. Its initial work focused on the notification system. Notification is a simple procedure which does not require the submission of any supporting documents. It is particularly suited to the nuclear activities that present the lowest risks for people and the environment. Since April 2018, RNAs in the industrial, research or veterinary sectors, that comes under the notification system, can carry out the notification procedure via the ASN “on-line services” portal. Through ASN resolution 2018-DC-0649 of 18 October 2018 amended, approved on 21 November 2018, ASN has extended the list of activities subject to notification. The notification system extension has to date concerned about 8,000 files which were previously subject to the licensing system. The new registration system (simplified authorisation) The new registration system came into effect on 1 July 2021, after approval on 4 March 2021 of ASN resolution 2021-DC0703 of 4 February 2021. This resolution governs nuclear activities in industry, research and veterinary applications, as nuclear activities for medical purposes that come under this system are governed by another resolution (see chapter 7). This system applies to certain sources of ionising radiation, whether in the form of sealed or unsealed radioactive sources, and X-ray generators, where the risks and drawbacks of possessing or using them can be prevented by complying with the specific general requirements set by the resolution. The resolution therefore defines, apart from the nuclear activities concerned, the content of the simplified authorisation application and the conditions for exercising (specific general requirements) the nuclear activity with which the licensees must comply. Its entry into effect marks the second stage – following that of extension of the notification system – of effective implementation of the reform of small-scale nuclear activity regulation, aiming to better materialise a graded approach to the risks. The resolution effectively implies significant alleviations in the administrative procedures compared with those for nuclear activities subject to licensing, such as: a simplified application (both in the information and the substantiation documents to provide), ten year registration validity by default (and even unlimited validity by default for certain nuclear activities), the possibility of applying for registration via the on-line registration service which is available on asn.fr, review and assessment by ASN within six months, with silence after six months being considered as acceptance of registration of the applicant nuclear activity. Entry into effect of the registration system should ultimately concern between 1,200 and 2,000 licensees in industry, research and veterinary applications, hitherto subject to the licensing system. However, the number will not be able to be accurately quantified until a five-year period has expired (1 July 2026). This is because, in accordance with the principle of grandfathering, the licenses issued before 1 January 2021 will act as registration until the license reaches term, on condition that in the interim there is no change in the nuclear activity. 2.4.3 Statistics for the year 2024 Suppliers In view of the fundamental role played by the suppliers of radioactive sources or devices containing them in the radiation protection of future users (see point 2.4.1), ASN exercises tightened oversight in this field. During 2024, 126 radioactive source supply license applications or license renewal applications were examined by ASN, and 35 inspections were carried out (all ionising radiation sources combined). Users The case of radioactive sources In 2024, ASN reviewed and issued 6 new licences, 202 license renewals or updates, 46 license cancellations, and 166 registration decisions. ASN also issued 426 notification acknowledgements for sealed radioactive sources in 2024. Graph 6 shows the regulatory acts issued by ASN for radio- active sources in 2024 and, where applicable, their development over the last five years. The entry into effect of ASN resolution 2018-DC-0649 of 18 October 2018 amended (see point 2.4.2) is the main reason for the very large drop in the number of licenses issued in favour of the issuance of notification acknowledgements, and illustrates the concrete application of the graded approach to risk control. This drop will become greater in the coming years as the new registration system (see point 2.4.3) applicable since 1 July 2021 gradually increases in scale. Once the license, registration or notification acknowledgement is obtained, the holder can procure sources. To do this, it receives supply request forms from IRSN, enabling IRSN to verify – as part of its duty to keep the national inventory of ionising radiation sources up to date – that the orders are in conformity with the license, registration or notification acknowledgement issued to the user and the license of its supplier. If the order is correct, the transfer is then recorded by IRSN, which notifies the interested parties that delivery can take place. In the event of difficulty, the transfer is not validated and IRSN refers the case to ASN (see box page above). As of 1 January 2025, further to the merging of ASN and IRSN, the entire process will be managed by the Authority for Nuclear Safety and Radiation Protection (ASNR), without this calling into question the verification and validation steps. Administrative tracking of radioactive sources Articles R. 1333‑154, 156 and 157 of the Public Health Code provide for the prior registration by IRSN of transfers of radioactive sources and Article R. 1333‑158 for administrative tracking of these sources. ASN resolution 2015-DC-0521 of 8 September 2015 relative to the tracking and methods of registering radionuclides in the form of radioactive sources and products or devices containing them details the methods of registering transfers and the rules for tracking radionuclides in the form of radioactive sources. This resolution, applicable as of 1 January 2016, takes into account the existing mode of functioning and supplements it as follows by: • grading source administrative tracking according to how dangerous the sources are; • confirming the non-registration of sources whose activity is below the exemption thresholds; • imposing deadlines between the registering of source transfer and the actual transfer; • making it an obligation for each source to be accompanied by a “source certificate” indicating all its characteristics and which must be transmitted to IRSN within two months after receiving the source. As of 1 January 2025, the missions ASN and IRSN are taken over by ASNR. 260 ASN Report on the state of nuclear safety and radiation protection in France in 2024 Sources of ionising radiation and their industrial, veterinary and research applications
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