LES ACTIVITÉS NUCLÉAIRES : RAYONNEMENTS IONISANTS ET RISQUES POUR LA SANTÉ ET L’ENVIRONNEMENT 4 – Manufacturers and distributors of radioactive sources and their oversight by ASNR 4.1 The issues and challenges The aim of ASNR oversight of the suppliers of radioactive sources or devices containing them is to ensure the radiation protection of the future users. It is based on the technical examination of the devices and sources with respect to operating safety and radiation protection conditions during future utilisation and maintenance. It also allows the tracking of source transfers and the recovery and disposal of disused or end-of-life sources. Source suppliers also play a teaching role with respect to users. At present, only the suppliers of sealed radioactive sources (or devices containing them) and of unsealed radioactive sources are regulated in France (see point 2.3.1). ASNR lists just under 100 suppliers with high safety-significant business, including 38 low and medium-energy cyclotrons on 32 sites which are currently licensed under the Public Health Code. Among these 38 cyclotrons, 35 are in operation and produce radionuclides. Cyclotrons are used to produce positron-emitting radionuclides in unsealed sources (primarily fluorine-18). These radionuclides are used either for medical applications, especially in vivo diagnosis, or in clinical trial protocols (human subject research), or for research activities. Cyclotrons apart, the company Orano Med has established a production site for lead-212-based radiopharmaceutical drugs in the north of France. The centre’s purpose will be to manufacture and distribute these medicines for alphatherapy across Europe, particularly in connection with participation in clinical trials. The manufacturing process shall be carried out in shielded enclosures. In May 2025, ASNR authorised this site to carry out its validation tests. This authorisation is valid until the end of June 2026, and should be followed by a production authorisation as soon as the tests have been successfully completed. 4.2 Cyclotrons Operation As at 31 December 2025, one cyclotron was on standby, three shut down and 35 in service. Among the 35 cyclotrons in routine operation, 26 are used to produce radiopharmaceuticals intended, at the very least, for in vivo diagnosis, sometimes with medical or non-medical research as an additional end-purpose, eight produce radionuclides for medical or non-medical research purposes, and one produces radionuclides exclusively for non-medical research. A new cyclotron facility for producing radiopharmaceutical drugs, built in the inner suburbs of Rennes, is due to undergo qualification in 2025. ASNR authorisation to complete the tests is valid until the end of February 2026. By the end of this period, production of radiopharmaceuticals is expected to be up and running. In the medium term, this site is intended to replace the current facility located within the Rennes University Hospital complex. The application for the construction of a new cyclotron at the Toulouse cancer centre was submitted in June 2025, and the assessment process, which includes an expert review phase, has begun. Other projects, which are less advanced at this stage, could be the subject of authorisation applications in 2026, notably the installation of a cyclotron in Grenoble, and another in the Nantes region, which could also host a production site for astatine-211. Finally, plans to organise the distribution of radiopharmaceuticals to Corsica from the production sites in Marseille are also under consideration. LA RÉUNION MARTINIQUE GUADELOUPE Research (excluding medical) Research (medical and non-medical) Production for in vivo diagnosis (primarily) and for research (medical or non-medical) On standby Planned Stopped Location of cyclotrons in France 256 ASNR Report on the state of nuclear safety and radiation protection in France in 2025
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