ASN Report 2015

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The following are now subject to the Public Health Code
system:
• establishmentsholdingor using sealed radioactive sources
subject to notification or licensing on account of section
1715 of the ICPE nomenclature;
• establishments holding unsealed radionuclides in
quantities of less than 10 m 3 previously subject to
notification or licensing under section1715 of the ICPE
nomenclature.
The prescriptions applicable to these installations are now
those of the Public Health Code and the Labour Code.
However, Article 4 of the abovementioned Decree
provides that the license or notification delivered under
section 1715 shall continue to be valid as a license or
notification under the Public Health Code until a new
license is obtained under the Public Health Code or,
failing this, for a maximum period of five years, that
is to say until 4th September 2019 at the latest. Any
change relating to the license shall either be notified to
ASN or form the subject of a new license application,
depending on the case.
Only the establishments holding unsealed radioactive
substances in quantities exceeding 10m3 are henceforth
subject to the system for classified installations (excluding
the medical sector and particle accelerators). Any sealed
radioactive sources also possessed or used by these
establishments are regulated by ASN under the Public
Health Code.
Nuclear materials are subject to specific regulations
provided for in Article L. 1333-2 of the Defence Code.
Application of these regulations is overseen by theMinister
of Defence with regard to nuclear materials intended for
defence needs, and by the Minister in charge of Energy
with regard to nuclearmaterials intended for any other use.
4.2 Licensing and notification
of ionising radiation sources used
for non-medical purposes
4.2.1 Integration of the principles of radiation
protection in the regulation of non-medical activities
ASN verifies application of the three major principles
governing radiation protection and which are written
into the Public Health Code (Article L. 1333-1), namely
justification, optimisation of exposure and dose limitation
(see chapter 2).
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 a generic prohibition is
declared, or the license required on account of radiation
protection is not issued or is not extended. For existing
activities, justification is reassessedwhen license renewal
applications are made if the current state of knowledge
and technology warrants it.
Optimisation is a notion that must be considered in the
technical and economic context, and it requires a high
level of involvement on the part of the professionals. ASN
considers in particular that the suppliers of devices are
at the core of the optimisation approach (see point 3).
They are 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 optimisationwhen
examining the license application files, when conducting
its inspections, andwhen analysing the various significant
events notified to it.
4.2.2 Applicable licensing and notification systems
Applications relating to the holding and use of ionising
radiation sources are reviewed by the regional divisions
of ASN. License applications for the manufacture and
distribution of sources or devices containing sources are
examined at a central, national level.
The licensing system
As part of a simplificationprocesswith a graded approach
based on the radiological risks and implications, ASN
has produced and deployed licensing application forms
adapted to each activitywhich are available on
Several formswere revised in2015 to incorporate changes
in regulations and experience feedback.
To better integrate the true situation of responsibilities in
the non-medical sectors, where the radioactive sources
and devices are often managed more by an entity than
by an individual, these new forms allow representatives
of artificial persons to apply for a license, pursuant to
ArticleR. 1333-24of the PublicHealthCode. They also list
the documents thatmust be enclosedwith the application.
All the other documents listed in the appendix to ASN
resolution 2010-DC-0192 of 22nd July 2010 must of
course be held by the applicant and kept at the disposal
of the inspectors in the event of verification. It ismoreover
possible that ASNwill request further informationduring
its examination of the license application.
Small-scalenuclear activities standout by their considerable
diversity and the large number of licensees involved.
ASN must therefore adapt its efforts to their radiation
protection implications to ensure effective oversight of
these activities. In this perspective, it is continuing to
implement its graded approachwhich consists in adapting
the regulatory constraints and the level of oversight to the
risks that the nuclear activity presents. Furthermore, as
part of the transposition of Directive 2013/59/Euratomof
5th December 2013, ASN has started an overall revision
of the regulatory provisions (see chapter 3).
333 CHAPTER 10: INDUSTRIAL, RESEARCH AND VETERINARY USES AND SOURCE SECURITY
ASN report on the state of nuclear safety and radiation protection in France in 2015