ENSI is the licensing authority for the transport of radioactive substances from and to nuclear installations unless these licenses are subject to nuclear energy legislation (nuclear materials and radioactive waste). For all other transports of radioactive substances (in the medical, industrial and research sectors), the licensing authority is the Federal Office of Public Health (FOPH) (Article 11 of the Radiological Protection Ordinance (RPO) of 26 April 2017).
The various licensing authorities issue transport licenses pursuant to the RPA applying a coordinated procedure. In response to an application, an existing license issued by one authority will simply be approved without additional checks by the other authority for the corresponding area of responsibility. For new applications, this takes place without a separate application, provided that this has already been requested in the application.
“Swiss nuclear installations” are facilities with a license according to the Swiss Nuclear Energy Act. Currently these are the nuclear power plants at Mühleberg, Gösgen, Beznau and Leibstadt , the central interim storage facility (Zwilag AG), various facilities of the Paul Scherrer Institute (PSI) and facilities of the Swiss Federal Institute of Technology, Lausanne (EPFL) and the University of Basel. CERN (the European Council for Nuclear Research) is not a nuclear installation, but an extra-territorial research facility.
For transport of exempted packages (UN 2908 to 2911) no license is required.
ENSI examines whether the requirements for the issuance of a license as per Article 31 RPA are fulfilled for each individual application. The license is issued for a maximum of 10 years and a fee is payable for it. ENSI links licenses to standardised requirements that facilitate the supervision of licensee , such as specified notification and reporting obligations (see below).
For trans-boundary shipments to or from nuclear installations, the nuclear installation that ships or receives the substances must have an applicable import or export license; this also applies to radioactive substances in exempted packages. For the import and export of sources of categories 1 and 2 (activity of more than 10 times the values stated in Annex 9 to the RPO) ENSI requires a specific application to be submitted.
Submission of applications, reporting and notification obligations
To assist the applicants ENSI provides a form stating which documents must be submitted. This form may also be used to notify changes to the licensee’s qualifying conditions for the license during the validity period of the license and to submit copies of updated certificates.
According to Article 11b of the Administrative Procedure Act (APA), official decrees, such as a transport license, must be delivered to a postal address in Switzerland. For this reason, foreign applicants shall notify to ENSI a delivery address in Switzerland.
The licensee must submit annual reports on the transport operations it has undertaken according to its license. If the licensee is simultaneously the operator of a nuclear installation, this reporting is included in the annual report as per Guideline ENSI-B02. Licensees who do not report in this way are obliged to submit a separate annual notification in accordance with the requirement stated in their license. This also applies, if no transport operations were undertaken under the terms of the license. The following form is intended to provide assistance with this reporting. The form can also be used to notify to ENSI changes of the qualifying conditions for the license including amendments and updates in particular.