Radioaktive Stoffe; Beantragung einer Genehmigung für den Umgang

The handling of other radioactive substances or the significant modification of an activity requiring a license in connection with the handling of other radioactive substances is subject to licensing and must be applied for with the competent authority.

The handling of other radioactive substances (new approval) and the significant modification of a so-called "activity requiring approval" in connection with the handling of other radioactive substances (modification approval) requires approval.

The Bavarian State Office for the Environment (LfU), as the competent authority, issues the license for handling other radioactive substances upon application. The documents and evidence required for the application for approval are regulated in the Radiation Protection Act and must be provided in the course of the procedure.

"Other radioactive substances" are primarily radioactive substances that are not nuclear fuels. A license in accordance with the Atomic Energy Act is required for handling the latter. Exceptions are small quantities of nuclear fuels, which are considered other radioactive substances under certain conditions.

The term "handling" is defined as an activity in the Radiation Protection Act (StrlSchG). This refers to the extraction, storage, treatment, processing and other use or disposal of artificially produced and naturally occurring radioactive substances. A license for handling other radioactive substances is only required if the activity of the substances exceeds the exemption limits of the Radiation Protection Ordinance (StrlSchV).

• The following documents must be submitted:
  • Proof of liability insurance under radiation protection law
  • Proof of the applicant's reliability by means of a certificate of good conduct or form
  • Proof of acquisition of the required specialist knowledge in radiation protection
  • Current proof of updating the required specialist knowledge in radiation protection
  • License to practice medicine
  • Proof of registration with the medical or dental authority (for use on humans)
  • Extract from the commercial register or partnership register
  • Proof of a safety concept

Applications for authorization to handle other radioactive substances can be submitted to the LfU by legal entities and natural persons who plan to handle radioactive substances in Bavaria.

Important general licensing requirements:

• The handling site, for example the operating site where the radioactive substances or equipment are to be used or stored, must be located in Bavaria.
  If you wish to use radioactive substances in a mobile manner, you or your institution must have your habitual residence or registered office in Bavaria.
• There are no facts that give rise to concerns about the reliability of the applicant or the person authorized to represent them.
• Appointment of radiation protection officers with the necessary expertise to perform the tasks and in sufficient numbers
• A sufficient number of personnel to carry out the activities safely
• Evidence of state-of-the-art technology and measures to comply with the protection regulations

Important additional special requirements for activities in connection with use on humans:

• License to practice medicine or dentistry (or permission to temporarily practice medicine or dentistry)
• Ensuring the availability of medical physics experts in defined treatments in sufficient numbers
• Proof of ensuring the lowest possible exposure during examinations or the dose distribution required for the intended purposes during treatments
• Further requirements also apply to the authorization for teleradiology

Important additional special requirements for activities in connection with the use on animals in veterinary medicine:

• License to practice as a veterinarian, physician or dentist (or permission to temporarily practice as a veterinarian, physician or dentist)

All applicable application requirements are regulated in Sections 13 and 14 and Annex 2 Part B of the Radiation Protection Act (StrlSchG). In principle, the applicant is obliged to obtain information on the applicable legal requirements under the StrlSchG.

100.00 to 9,250.00 EUR

The necessary documents must be submitted to the LfU together with the application.

The application can be submitted informally by post and/or e-mail or electronically via the application for a license for the handling of other radioactive substances (see "Online procedure").

The LfU checks the completeness of the documents and the licensing requirements and, if necessary, requests the submission of missing evidence.

If necessary, the LfU may involve experts in the assessment process.

After a positive review of the application and all documents, the LfU issues the license for handling other radioactive substances.

The decision will be sent by post by the LfU.

6 weeks to 6 months

The application must be submitted in good time before the planned start of activities. The handling of radioactive substances may only take place once a permit has been issued.

The examination of the structural requirements for radiation protection as a prerequisite for approval is also examined by the LfU as part of the approval procedure. The LfU recommends contacting the authorities at an early stage and involving them in the planning process so that any necessary structural requirements can be included in the construction planning.

The fire and theft protection requirements for the storage of other radioactive materials must be assessed by qualified experts.

The required theft protection measures from the HRQ value in accordance with the Radiation Protection Ordinance Annex 4 Table 1 Column 4 require more far-reaching security concepts, which are described in the Guideline for Protection against Interference Measures and Other Effects of Third Parties when Handling and Transporting Other Radioactive Substances (SEWD Guideline for Other Radioactive Substances). The SEWD Guideline is subject to state secrecy and is therefore a non-public document. In this case, please contact the LfU at an early stage.

An appeal against the decision may be lodged with the competent administrative court within one month of notification.