French Public Health Code
In forceI.-Subject to the provisions of Article R. 1333-107, the following are exempt from the authorisation, registration or declaration provided for in Article L. 1333-8:
1° The possession, manufacture, use, distribution, import and export of radioactive sources and products or devices containing them if the value of the coefficient Q corresponding to the weighted sum of the radionuclide activities present at any time in the place where the activity is carried out or is the subject of the activity, divided by the exemption limit value set in the second column of table 2 of appendix 13-8 for each of these radionuclides is less than 1 ;
2° The possession, manufacture, use, distribution, import and export of radioactive sources and products or devices containing them if the value of the QM coefficient corresponding to the weighted sum of the radionuclide mass activities of each homogeneous or related assembly present at any time in the place where the activity is carried out or is the subject of the activity, divided by the exemption limit value set in Table 1 or in the third column of Table 2 of Annex 13-8 for each of these radionuclides is less than 1;
3° The nuclear activities mentioned in 2° of the I of Article R. 1333-104 when the components of the electrical apparatus operate at a potential difference less than or equal to 5 kV;
4° The nuclear activities mentioned in a and b of 2° of the I of Article R. 1333-104 and in c of this same 2° when the electrical device is an electron microscope, if the devices do not create, by design and under normal conditions of use, at any point located at a distance of 0.1 m from their accessible surface, a dose equivalent rate greater than 1 microSv. h-1 and meet one of the following two conditions:
a) The equipment is covered by an exemption certificate issued by a decision of the French Nuclear Safety Authority (Autorité de sûreté nucléaire) approved by the Minister responsible for radiation protection, because it provides effective protection for people and the environment against ionising radiation;
b) The electrical equipment used is a cathode ray tube for displaying images, or any other electrical equipment operating at a potential difference of 30 kV or less;
5° All or some of the activities mentioned in 1° of the I of Article R. 1333-104 for consumer goods and construction products that benefit from an exemption granted in application of Article R. 1333-4, when this exemption provides for such an exemption for this or these activities.
II.-For the application of I, the words :
1° By design means without taking into account the specific radiation protection improvements made by the user to a device ;
2° Normal conditions of use means the operating conditions laid down by the manufacturer or supplier of the equipment and incorporating the reasonably foreseeable hazards inherent in these conditions of use;
3° Accessible surface means any area accessible by all or part of a person (finger, hand, whole body, etc.), voluntarily or involuntarily, without dismantling or physically modifying the appliance or its accessories.
III - The provisions of 1° and 2° of I do not apply to the distribution, import and export of radioactive sources used for their radioactive, fissile or fertile properties.
IV - For radionuclides not listed in tables 1 and 2 of appendix 13-8, exemption limit values may be established by order of the minister responsible for radiation protection.
After examining the conditions of practice and the justification for a given category of activity, exemption limit values higher than those set in tables 1 and 2 of appendix 13-8 may be adopted by decision of the Nuclear Safety Authority approved by the Minister responsible for radiation protection provided that :
1° The performance of this activity does not require workers to be classified within the meaning of Article R. 4451-57 of the Labour Code;
2° The criteria mentioned in e of point 3 of Annex VII of Council Directive 2013/59/Euratom of 5 December 2013 are met.
