The new system of licensing or notification, which covers all sources of ionising radiation, is now described in full in section 3 of chapter III of part III of book III of the Public Health Code. All medical, industrial and research applications are concerned by these measures. This more specifically concerns the manufacture, possession, distribution - including import and export, and use of radionuclides or products and devices containing them. The use of X-ray equipment is subject to notification for medical radio-diagnostic (except for very large systems) or to licensing in all other cases.

It should be noted that the licensing system applies irrespectively to companies or facilities which have radionuclides on-site, as well as to those which trade in them without directly possessing them. This is in conformity with directive 96/29/Euratom which explicitly mentions both import and export. From the public health and safety viewpoint, this obligation is essential to close monitoring of source movements and to prevent accidents as a result of stray sources.

It should be remembered that, in accordance with article L. 1333-4 of the Public Health Code, licences for industries subject to the Mining Code, for BNIs and for ICPEs, replace the radiation protection licence. However, this exception does not concern ionising radiation applications for medical purposes or for biomedical research.

The modalities for submitting licensing or registration applications were specified in the order of 14 May 2004.

a) The medical, biomedical research and medico-legal fields

For medical and biomedical research applications, the licensing system contains no exemptions:

• the licences required for the manufacture of radionuclides, or products and devices containing them, as well as for their distribution, import or export, are issued by the French Health Products Safety Agency (AFSSAPS);

• the licences required for the use of radionuclides, products or devices containing them, are issued at a national level by the ASN;

• X-ray generators, which hitherto were subject to technical approval by OPRI, are now subject to notification to the Prefect if they are of low-intensity (radiology or dental surgery), while a system of licences issued by the ASN applies to sophisticated equipment (scanners).

X-ray installations used for medico-legal procedures are subject to a system of licensing or notification applicable to medical installations, whenever their operation involves exposing persons to ionising radiation.

Furthermore, to be able to carry out biomedical research, the "researcher" must obtain a premise licence (article L.1124-6 of the Public Health Code). The licence is issued by the Director General of AFSSAPS with regard to medical devices, drugs and cosmetics, or by the Minister for Health (General Directorate for Health) with regard to physiology, physiopathology, epidemiology and genetics research.

b) The industrial and non-medical research fields

The ASN is also responsible for issuing licences for industrial and non-medical research applications, on behalf of the Minister for Health. In these fields, this concerns:

• the import, export and distribution of radionuclides and products or devices containing them;

• the manufacture of radionuclides, products or devices containing them, the use of devices emitting X-rays or of radioactive sources, the use of accelerators other than electron microscopes and the irradiation of products of whatsoever nature, including foodstuffs, with the exception of activities which are licensed under the terms of the Mining Code, the BNI system or that applicable to ICPEs.

New criteria for licensing exemption incorporated in directive 96/29/Euratom (Appendix 1, table A) have been introduced into and appended to the Public Health Code (table A, appendix 13-8). Values for additional radionuclides were introduced in the order of 2 December 2003. These criteria replace those given in decree 66-450 of 20 June 1966 concerning the general principles of protection against ionising radiation. Exemption will be possible if one of the following conditions is met:
- the total quantity of radionuclides possessed is less than the exemption values in Bq;
- the radionuclide concentrations are less than the exemption values in Bq/kg.

For this latter criterion, the decree introduces an additional mass restriction criterion (the mass of material used must be less than 1 tonne). This reference criterion was used when preparing the scenarios used to define the exemption values. The transposition into French law is thus stricter than directive 96/29/Euratom which does not introduce this mass limit. Introduction of this restrictive criterion should avoid the risk of the radioactive material being diluted in order to fall below the exemption threshold.

The way this system of licences, issued according to the Public Health Code, interfaces with the system of classified installations was clarified by a circular from the Minister for Ecology and Sustainable Development on 19 January 2004.

c) Technical supervision of radiation protection

Technical supervision of the radiation protection organisation, including supervision of the management of radioactive sources and any associated waste, is entrusted to approved organisations (R. 1333-44 of the Public Health Code). The type and frequency of the inspections were defined by the order of 26 October 2005, mentioned in point 1.2.1.