Activities involving radiation sources subject to authorisation

General information

Practices involving radiation sources require a licence in accordance with the Strahlenschutzgesetz (Radiation Protection Act – StrSchG). According to section 3 (73) of the StrSchG "practice" is defined as "a human activity that may increase the exposure of persons to radiation from a radiation source and is treated as a planned exposure situation".

Companies that carry out activities with naturally occurring radioactive materials are also subject to the licensing or reporting requirement in accordance with the StrSchG, unless an exception provision under the Allgemeine Strahlenschutzverordnung (General Radiation Protection Ordinance – AllgStrSchV) applies.

Depending on the type and hazard potential of the intended practice, radiation protection law provides for different licensing procedures:

• Two-stage licensing procedure: If radiation protection measures are required already at the time of the setting up of facilities, a two-stage procedure is to be applied (sections 15, 16, 17 of the StrSchG). The first step is to obtain a construction licence and the second step is to obtain a licence to carry out the practice.
• One-stage licensing procedure in accordance with sections 15, 17 of the StrSchG

For X-ray facilities with a nominal voltage of up to 100 kilovolts, the following applies. Provided that the necessary structural radiation protection measures are available, a two-stage licensing procedure can be dealt with in a joint authority procedure (section 9 of the AllgStrSchV).

Any modification of a practice or of structural radiation protection measures is also subject to authorisation (section 18 of the StrSchG). Such an application must be submitted to the licensing authority. The procedure is similar to an initial licence.

A central prerequisite for a licence according to sections 15 to 17 of the StrSchG is radiation protection expertise in the company. For this purpose, the company must appoint a "radiation protection officer" with respect to the authorities. This person must have received radiation protection training from an officially authorised training centre in addition to the relevant education. The central tasks of the radiation protection officer are defined in section 64 paragraph 1 of the StrSchG. It is important to note that it is the licence holder who is responsible to the radiation protection authority for compliance with the provision of radiation protection law, not the radiation protection officer.

A special case is an approval according to section 77 of the StrSchG for companies whose employees carry out work as so-called "outside workers". This is the case if the workers do not carry out work in their own company but in other companies in controlled or supervised areas and are to be classified as workers exposed to radiation. In such cases, both companies are responsible for the protection of the workers; additional regulations apply, such as the keeping of a radiation protection pass for external workers working abroad (section 81 of the StrSchG and section 118 of the AllgStrSchV).

Also, there is the special case of approval of a certain type of equipment, which is used in larger quantities, within the scope of type approval. If a device has such a type approval, the company that wishes to use such a device is not required to obtain a permit in accordance with sections 15 to 17 of the StrSchG. However, there is an obligation to notify the competent radiation protection authority, for example, before the device is used for the first time (section 35 paragraph 4 of the StrSchG and section 25 of the AllgStrSchV).

Enterprises affected

Concerned are those companies that carry out practices with radiation sources (unless an exception from the licensing requirement according to section 7 of the AllgStrSchV has been granted). Companies that carry out practices involving naturally occurring radioactive materials are also subject to the licensing requirement, unless an exception applies.

Deadlines

There are no specific deadlines to be observed.

Competent authority

In principle, the application must be submitted to the respective office of the provincial government. In the case of licences in process concentration with a commercial operating licence, the application must be submitted to the competent district administrative authority.

Procedure

The licensing procedure is carried out upon written application by the company. The application must contain all documents that enable the authority to verify whether the conditions for the safe performance of the practice are fulfilled.

After positive completion of the assessment, the authority issues a notice of decision containing the official authorisation within six months of the application. For diagnostic X-ray facilities, the authority must issue a notice of decision within three months of the application being submitted. The notice has to contain the necessary requirements and conditions that must be met by the company.

Required documents

The documents that have to be submitted for what type of practice is specified in section 10 of the AllgStrSchV. In the case of highly radioactive sealed sources, proof of insurance for the safe disposal of the source and a take-back agreement with the supplier is also required. An application for the licensing of a practice with artificial radiation sources shall include the following documents:

1. an exact description of the intended practice;
2. technical and other information on the radiation source for which radiation protection is to be ensured;
3. where applicable, a schematic plan showing the site at which the radiation source has been set up and the constructional radiation protection measures;
4. where applicable, security measures for radioactive sources;
5. where applicable, information on discharges;
6. where applicable, information on radioactive waste with respect to
   1. type and average amount per year,
   2. the radionuclides contained and their activity concentrations,
   3. the intended management and/or disposal,
   4. any temporary storage;
7. training certificates of the designated radiation protection officer;
8. anticipated occupational and public exposures in normal operation, unless sufficient experience has already been gained for the relevant practice;
9. all other information necessary for an evaluation of the application.

An application for the licensing of a practice involving naturally occurring radioactive material shall include the following documents:

1. type of practice pursuant to section 11 of the AllgStrSchV or, as the case may be, type of practice pursuant to section 27 StrSchG;
2. an exact description of the intended practice, especially technical and other information that is relevant for radiation protection on the relevant work processes, where necessary with the enclosure of schematic illustrations;
3. where applicable, a schematic plan showing the constructional radiation protection measures taken;
4. estimated occupational and public exposures in normal operation;
5. where applicable, information on discharges;
6. where applicable, information on residues with respect to
   1. type and average amount per year,
   2. the radionuclides contained and their activity concentrations,
   3. the intended management and/or disposal,
   4. any temporary storage in the undertaking;
7. training certificates of the designated radiation protection officer;
8. all other information necessary for an evaluation of the application.

In addition, the application shall enclose a copy of the report provided by the certified monitoring service pursuant to section 13 paragraph 1 of the AllgStrSchV.

Costs and fees

The costs are based on Appendix 1 − Section VII of the Bundesverwaltungsabgabenverordnung (Federal Administrative Charges Ordinance) and section 14, tariff items (5) and (6) of the Gebührengesetz (Fees Act).

Further information

Authorisation of the work performed by outside workers exposed to radiation

Legal bases

• sections 7, 9, 10, 25, 81, 118 of the Allgemeine Strahlenschutzverordnung
  (General Radiation Protection Ordinance^{Unofficial English translation} – AllgStrSchV)
• sections 3, 15 to 18, 35, 61, 64, 77, 81 of the Strahlenschutzgesetz
  (Radiation Protection Act^{Unofficial English translation} – StrSchG)