Lastly, to supplement the information for professionals, a brochure intended for RNAs who only possess category D sources (for which the number of regulatory obligations is limited) is also available on asn.fr. 2.4 LICENSING, REGISTRATION AND NOTIFICATION OF IONISING RADIATION SOURCES USED FOR INDUSTRIAL, RESEARCH OR VETERINARY PURPOSES 2.4.1 Integration of the principles of radiation protection in the regulation of non‑medical activities With regard to radiation protection, ASN verifies application of the three major principles governing radiation protection which are written into the Public Health Code (Article L. 1333‑2), namely: justification, optimisation of exposure and dose limitation. Assessment of the expected benefit of a nuclear activity and the corresponding health drawbacks may lead to prohibition of an activity for which the benefit does not seem to outweigh the risk. Either generic prohibition is declared, or the license required for radiation protection purposes is not issued or is not extended. For the existing activities, the elements supporting implementation of the justification principle are recorded in writing by the person RNA, and are updated every five years and whenever there is a significant change in available knowledge or techniques. Optimisation is a notion that must be considered in the technical and economic context, and it requires a high level of involvement of the professionals. ASN considers in particular that the suppliers of devices are at the core of the optimisation approach (see point 4). They are effectively responsible for putting the devices on the market and must therefore design them such that the exposure of the future users is minimised. ASN also checks application of the principle of optimisation when examining the license applications, when conducting its inspections, and when analysing reported significant events. 2.4.2 The licensing, registration and notification systems Applications relating to the possession and utilisation of ionising radiation are examined by the ASN regional divisions, while those concerning the manufacture and supply of sources or devices containing sources are examined at the ASN head office by the Department of Transport and Sources (DTS). The entry into effect on 1 July 2018 of Decree 2018‑434 of 4 June 2018, introducing various provisions in the nuclear field, has introduced a third administrative system lying between the notification system and the licensing system: it is a simplified authorisation system called the “registration system”. ASN has prepared a classification system to allocate the various categories of nuclear activities to one of these three systems, whose implementation began on 1 January 2019 with the entry into effect of the ASN resolution extending the notification system to additional nuclear activities which until then were subject to licensing, and continued on 1 July 2021 with the entry into effect of the resolution concerning the registration system. The licensing system Small‑scale nuclear activities in the industrial sector stand out by their considerable diversity and the large number of licensees involved. The licensing system is designed to regulate the nuclear activities involving the greatest radiation protection implications, for which ASN checks, when examining the license application, that the applicant has identified the risks and that the measures intended to limit their effects have been studied and planned for. To support this process, licensing application forms adapted to each activity are available on asn.fr. These forms are designed for the licensing applications to be formulated by the representative of a legal person, although it is possible for a physical person to apply for a license. These forms list the documents that must be enclosed with the application. All the other documents listed in the appendix to ASN resolution 2010‑DC‑0192 of 22 July 2010 must be held by the applicant and kept at the disposal of the inspectors in the event of inspection. On completion of the examination, and provided that the measures described by the applicant are satisfactory, a limited‑term (usually five years) license is issued for the exercise of the nuclear activity. To further the implementing of a graded approach in the oversight of the nuclear activities coming under the Public Health Code, ASN continued revising the above-mentioned resolution, which started in 2022. This will complete the work started in 2018 which has already led to revising of the notification system and creation of the registration system (see below). The notification system As part of the overhaul of the classification of nuclear activities into the three administrative systems introduced by the above‑mentioned 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, those RNA 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 7,000 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‑DC‑0703 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 ASN Report on the state of nuclear safety and radiation protection in France in 2023 253 • 08 • Sources of ionising radiation and their industrial, veterinary and research applications 08 05 15 11 04 14 06 07 13 AP 03 10 02 09 12 01
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