Assessment of the CEA Saclay site ASNR considers that the CEA Saclay site BNIs are operated under suitably safe conditions on the whole, and observes that the operations to reduce the radiological inventory stored in the BNIs – which have been in progress for several years now – continued in 2025. The decommissioning preparation operations and the decommissioning work are continuing for the facilities concerned. Managing their progress and controlling the associated schedules remain major challenges for CEA Saclay and are the subject of regular inspections and discussions with ASNR. On another note, further to the Fukushima Daiichi NPP accident (Japan), ASN had ordered the creation on the Saclay site of new emergency management facilities capable of withstanding extreme conditions. The project has suffered significant delays due to civil engineering faults, resulting in failure to meet the initial commissioning deadline of the end of 2021. Given the reduction in nuclear risk at the Saclay site following the shutdown of the Orphée (BNI 101) and Osiris (BNI 40) reactors, a requirement to complete the construction of new emergency management facilities set a new deadline of the end of 2024. Their commissioning was observed by ASNR in 2025, during an unannounced inspection that included an emergency response exercise. However, further information is still required on the identification of items important for the protection of interests, and on the premises organisation protocol. In addition, CEA’s on-site emergency plan has been updated, in particular to incorporate the new premises. In 2026, ASNR will keep a close eye to the emergency organisation and resources in place. As part of the operational experience feedback from significant events involving temperature sensors used for fire detection, ASNR carried out an inspection to examine the inspection and maintenance procedures for this equipment in the BNIs at CEA Saclay site. Clarifications are still needed on the specified requirements, as well as on the methods for maintaining and qualifying the sensors. Finally, in 2025, ASNR carried out a tightened inspection on the supervision of outside contractors, involving the technical departments of CEA Saclay site and six of the seven BNIs, in order to verify the implementation of the commitments made following the in-depth inspection carried out by the ASN in 2024. An overall improvement in CEA’s practices was noted, although the momentum needs to be maintained in terms of the BNIs. However, there are still shortcomings in the management of regulatory requirements, particularly in terms of formalisation and traceability of supervision, as well as in the technical control of protection important activities. CEA is expected to pay particular attention to these issues and to invest heavily in them. Artificial Radionuclide Production Plant of CIS bio international The Artificial Radionuclides Production Facility (UPRA) constitutes BNI 29. It was commissioned in 1964 on the Saclay site by CEA, which in 1990 created the CIS bio international subsidiary, the current licensee. In the early 2000s, this subsidiary was bought up by several companies specialising in nuclear medicine. In 2017, the parent company of CIS bio international acquired Mallinckrodt Nuclear Medicine LCC, now forming the Curium group, which owns three production sites (in the United States, France, and the Netherlands). The Curium group is an important player on the French and international market for the production and development of radiopharmaceutical products. The products are mainly used for the purposes of medical diagnoses, but also for therapeutic uses. They are manufactured using a cyclotron installed on the site or using radionuclides produced by outside suppliers or other facilities of the Curium group. Until 2019, the role of BNI 29 was also to recover disused sealed radioactive sources which were used for radiotherapy and industrial irradiation. Removal of these sources, which were stored in the facility, was completed in 2024. In 2025, in view of the conclusions of the periodic safety review of BNI 29, ASNR regulated its continued operation through a resolution in 25 September 2025 setting technical requirements. These requirements focus in particular on reducing the radiological inventory, as well as controlling the risks associated with fire, exposure to ionising radiation and the spread of radioactive materials. CIS bio international moreover decided to stop its iodine-131-based productions on the Saclay site at the end of 2019, which has significantly reduced the potential consequences of accident situations on the site. In 2025, the shutdown of the technetium generator production and packaging line has also led to a reduction in the radiological inventory present in certain buildings on the site. ASNR has finalised the review for updating the study of the radiological consequences for the population in an accident situation. This study takes into account changes in the site’s activities, as well as waste disposal planned by the licensee for the end of 2026. In this context, the work undertaken at the request of CIS bio international to obtain reduced-risk facility status will continue in 2026. In 2024 and 2025, as part of CIS bio international’s strategy to develop the production of new radiopharmaceuticals at the Saclay site, ASNR has authorised the manufacture of new products labelled copper-64 and lutetium-177. Since the deterioration in the overall level of safety at the facility observed in 2023, ASNR notes that CIS bio international has been working hard in 2025 on a number of issues considered to be priorities by ASNR. The time taken to send responses to follow-up letters from ASNR and reports of significant events has improved, while maintaining the quality of the information provided. In addition, the operator provided several safety-related files that had been awaited for several years, such as the analysis of human and organisational factors, the update of the safety report and general operating rules following the periodic safety review, the update of the On-site Emergency Plan (PUI), and requests for waste storage extensions. Nevertheless, as in previous years, ASNR notes from the inspections carried out in 2025 that CIS bio international is experiencing difficulties in meeting its commitments, with a significant number of postponements of deadlines associated with actions decided following inspections or significant events. With regard to waste, CIS bio international has complied with the formal notice issued by ASN in 2024 concerning the disposal of certain nuclear waste stored beyond the deadlines set out in the facility’s repository before the end of January 2025. ASNR also noted improvements in staff training in radiation protection, the receipt of packages of radioactive substances and the management of active effluents. However, improvements are expected in the supervision of outside contractors, the supervision of gaseous iodine emissions, the intervention procedures of the radiation protection centre of expertise and the management of emergency situations. The number of significant events reported to ASNR was stable compared with 2024. Nevertheless, human and organisational factors continue to predominate in the causes identified, and ASNR notes recurring problems relating to radiation protection of personnel, management of the last filtration levels and the identification and in-service monitoring of pressure equipment. Particular attention must be paid to these points. In addition, although the preventive and corrective maintenance actions undertaken in 2025 have led to an improvement in the leakage rate of certain enclosures and glove boxes, there are still significant gaps in a number of items of equipment. CIS bio international also continued to investigate the technical causes of the regularly observed Île‑de‑France 68 ABSTRACTS – ASNR Report on the state of nuclear safety and radiation protection in France in 2025
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