> Activities > TPL Sources Ionizing R. > Regulation

 

1. General Provisions


The articles L. 1333-4 and R. 1333-26 of the French Public Health Code (PHC) provide that nuclear activities are submitted to a regime of authorisation or declaration.
In France, two entities are entitled to issue authorisations and/ or register declarations.
The Nuclear Safety Authority (ASN) is competent in the entire medical field and also in the industrial field for installations which are not classified as “ICPE” (Classified Installations with regard to the environmental protection).
The “Préfets” are competent for ICPE installations (Article L. 511-1 of the PHC) of the industrial field.
There are 3 regimes applying to ionising radiation sources:


2. Medical field

This concerns ionising radiations for activities involving medicine, human biology and veterinary, medical and biomedical research, as well as import, distribution and export activities of radioactive substances or the use of X-ray apparatuses.
Such activities are only subject to the regimes of "Declaration" and "Authorisation". Up to now, the "Exemption" regime is not applicable to the medical field.
The ASN is the entitled authority for the entire medical field.


3. Industrial field

The three following regimes, exemption, declaration and authorisation apply to the Industrial field.

The proper regime is determined by the value of a factor Q obtained as follows:    

Q is function of the activity of the ionising radiation source (Ai) in Bq compared to the regulatory threshold (Aref i) in Bq.

Domaine Industriel

Statut du site

Regime of the ionising radiation so

Entitled authority

ICPE

Non ICPE

Q < 1

 

Exemption

N/A

1 < Q < 104

 

Declaration

Préfet

Q > 104

 

Authorisation

Préfet

 

Q > 1

Authorisation

ASN


An ionising radiation source stored within an ICPE but which can be used outside the ICPE will require on the one hand an authorisation / declaration from the Préfet and on the other hand an authorisation from the ASN.


4. Procedure

The authorisations and declarations have currently a 5 year validity period but the ASN is contemplating to extend the validity duration up to a maximum of 10 years.
Hard copies relating to the declarations and authorisation requests are available on the web-site of the ASN:http://www.asn.fr/index.php/Les-activites-controlees-par-l-ASN/Autres-activites-industrielles/Formulaires.


5. Relevant criteria for the distribution of ionising radiation source policies between the Nuclear Risk Insurance and the conventional market.

La nature du régime détermine la répartition entre le marché conventionnel et Assuratome.

REGIME

INTERVENTION

Exemption

Conventional insurance market

Declaration

Authorisation

Assuratome