96 ASN report on the state of nuclear safety and radiation protection in France in 2017 Chapter 03 - Regulations 1.2.4 Protection of the general public in a long-term exposure situation As defined in the French regulations, situations of lasting exposure to ionising radiation cover the situations following a radiological emergency situation which led to long-term contamination of the environment or property by radioactive substances on the one hand (post-accident situations) and any other situation of contamination by radioactive substances on the other (contaminated sites and soils). For post-accident situations, the regulations set a reference effective dose level of 20 mSv for the first year after the end of the radiological emergency situation for anyone exposed to radioactive substances as a result of the situation, in order to define the initial management strategy for the contaminated land, which is then reassessed yearly, with the eventual aim of reaching a reference effective dose level over one year of 1 mSv added to the background level predating the situation. For the other cases, the contamination of sites by radioactive substances is the result of a nuclear activity in the remote or more recent past (use of unsealed sources, radium industry, etc.) or an industrial activity utilising raw materials containing non-negligible quantities of natural radionuclides of the uranium or thorium family (activity generating exposure to “enhanced” natural radiation, see point 2.3.2). Most of these sites are listed in the inventory updated periodically and published by the French National Agency for Radioactive Waste Management (Andra). The contamination of the sites can also be the result of accidental releases of radioactive substances into the environment (see chapter 5). For these situations, in accordance with the international texts, no population exposure limit is set by the regulations: management of these sites is primarily based on a case by case application of the optimisation principle, taking account of a reference level of 1 mSv/year. A guide on the management of sites potentially contaminated by radioactive substances (published in December 2011), drafted under the coordination of ASN and the Ministry of the Environment, assisted by IRSN, describes how to deal with the various situations that could be encountered in the framework of the remediation of sites contaminated by radioactive substances. 2. Regulatory requirements applicable to small-scale nuclear activities The expression “small-scale nuclear” refers to medical, industrial and research activities utilising sources of ionising radiation when not covered by the BNI or ICPE Systems. They in particular concern the manufacture, possession and utilisation, distribution of radioactive sources and devices containing said sources, as well as electrical devices emitting ionising radiation. They also concern import and export, as well as transport. 2.1 Procedures and rules applicable to small-scale nuclear activities The procedures and rules applicable to small-scale nuclear activities, when they are not the beneficiaries of an exemption, are described in sections 6, 7 and 8 of Chapter III of Title III of Book III of the first part of the Public Health Code. ASN issues licenses and authorisations, carries out registration and receives notifications. 2.1.1 The existing licensing system and its changes The licensing system applies to companies or facilities which have and use sources of ionising radiation, but also to those that trade in them or use them but without directly possessing them. The ASN license may be issued for a limited period. In this case it can be renewed. The license application or notification is made with a form that can be downloaded from the www.asn.fr website or obtained from the ASN regional divisions. The conditions for filing license applications, established by Articles R. 1333-119 to R1333-124 of the Public Health Code, are set out by ASN resolution 2010-DC-192 of 22nd July 2010, which establishes the content of the files enclosed with the license application. The requirements applicable to the medical and non-medical fields are harmonised. It should be noted that the nuclear activities carried out in BNIs, ICPEs and facilities regulated under the Mining Code are not subject to the authorisation system of the Public Health Code (see chapter 10) but are however subject to the general regulations applicable to nuclear activities described in the Public Health Code. Licenses in the medical field ASN issues licenses for the use of radionuclides, products or devices containing them, used in nuclear medicine, FOCUS Update of the system of procedures applicable to small scale nuclear activities The decree under preparation provides the clarifications necessary for the implementation of the new system of procedures applicable to small-scale nuclear activities, pursuant to Article L. 1333-7 of the Public Health Code. A more graded approach to regulation will make it possible to implement a third system, between notification and authorisation: this is a simplified authorisation system called the “Registration System”. ASN is working on a breakdown of the various categories of nuclear activities among these three systems, on drafting the general requirements applicable to some of these activities and on defining the content of the notification and registration application files (justification of compliance with the general requirements) or authorisation application files (demonstration of protection of interests). This new breakdown will be gradually implemented as of 2018.