ASN Report 2015

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2. REGULATORY REQUIREMENTS
APPLICABLE TO SMALL-SCALE NUCLEAR
ACTIVITIES
The expression “small-scale nuclear” refers to medical,
industrial and research applications of ionising radiation
when not covered by the BNI or ICPE systems. This
more specifically concerns the manufacture, possession,
distribution – including import and export – and use of
radionuclides or products and devices containing them.
2.1 Procedures and rules applicable
to small-scale nuclear activities
The procedures and rules applicable to small-scale
nuclear activities, if not the beneficiaries of an exemption,
are described in section 3 of Chapter III of Title III of
Book III of the first part of the Public Health Code.
ASN issues licenses and approvals and is responsible
for registration. Notifications are filed with the ASN
regional divisions.
2.1.1 The licensing system
The licensing system applies indiscriminately to
companies or facilities which have and use radionuclides
on-site, and to those which trade in them or use them
without directly possessing them.
The ASN license may be issued for a limited period and
may in this case be renewed. The license application or
notification is made with a form that can be downloaded
from the website or obtained from the ASN
regional divisions. The conditions for filing license
applications, established by Articles R. 1333-23 et
seq. of the Public Health Code, are set out by ASN
resolution 2010-DC-192 of 22nd July 2010, which
establishes the content of the dossiers enclosed with
the license application. The requirements applicable
to the medical and non-medical fields are harmonised.
The forms implementing the resolutions have been
available on-line since 2011 and are regularly updated.
It should be noted that the licenses issued under the
authorisation systems for BNI, ICPE and Mining Code
industries (for ICPE and Mining Code industries,
the license is issued by the Prefect) constitute the
authorisation for manufacturing or owning ionising
radiation sources (see chapter 10), but do not constitute
exemption from compliance with the provisions of the
Public Health Code.
Licensing of medical applications
and biomedical research
ASN issues licenses for the use of radionuclides, products
or devices containing them, used in nuclear medicine,
brachytherapy, and for irradiation of blood products,
as well as for the use of particle accelerators in external
radiotherapy and computed tomography devices. For
medical applications and biomedical research, owing to
specific patient radiation protection issues, the decision
was taken not to use the clearance levels given in the
Public Health Code; the licensing system thus comprises
no exemptions.
Licensing of non-medical activities
ASN is responsible for issuing licenses for industrial
and non-medical research applications. This concerns:
• the import, export and distribution of radionuclides
and products or devices containing them;
• the manufacture, possession and use of radionuclides,
products or devices containing them, devices emitting
ionising radiation, the use of accelerators other than
electron microscopes and the irradiation of products
of any nature, including foodstuffs, with the exception
of activities which are licensed under the terms of the
Mining Code, the BNI legal system or that applicable
to ICPEs.
The licence exemption criteria are given in the appendix
to the Public Health Code (table A, appendix 13-8).
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.
2.1.2 The registration system
The Ordinance transposing Directive 2013/59/Euratomof
5th December 2013 introduces a simplified authorisation
system known as “registration”. This system can be
utilised for nuclear activities representing serious risks
or detrimental effects for the interests mentioned in
Article L.1333-7, when these risks and detrimental
effects can, in principle and in the light of the
characteristics of these activities and the conditions of
their implementation, be prevented by compliance with
the general prescriptions. Utilisation of this new system
will require relevant regulations and, for the activities
concerned, the drafting of general prescriptions.
101 CHAPTER 03: REGULATIONS
ASN report on the state of nuclear safety and radiation protection in France in 2015