Activities involving radiation sources subject to authorisation

General information

In most cases, practices involving radiation sources (referred to as "handling" in previous radiation protection law) require a licence in accordance with the Strahlenschutzgesetz 2020 (Radiation Protection Act 2020 – StrSchG 2020). According to section 3 (73) of the StrSchG 2020 "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".

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 to 17 of the StrSchG 2020). 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 and 17 of the StrSchG 2020

For X-ray facilities with a nominal voltage of up to 100 kilovolts, there is an innovation with regard to licensing procedures. 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 Allgemeine Strahlenschutzverordnung 2020 – Radiation Protection Ordinance 2020 – AllgStrSchV 2020).

Any modification of a practice or of structural radiation protection measures is also subject to authorisation (section 18 of the StrSchG 2020). 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 2020 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 2020. It is important to note that it is the licence holder who is responsible to the radiation protection authority for compliance with radiation protection law, not the radiation protection officer.

A special case is an approval according to section 77 of the StrSchG 2020 for companies whose employees carry out work as so-called "external 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 2020 and section 118 of the AllgStrSchV 2020).

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 2020. 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 2020 and section 25 of the AllgStrSchV 2020).

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 2020 has been granted). In contrast to the previous radiation protection law, 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 may contain 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 2020. 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.

Costs and fees

The costs are based on Appendix 1 − Section VII of the Bundesverwaltungsabgabenverordnung 1983 (Federal Administrative Charges Ordinance 1983) and section 14, tariff items (5) and (6) of the Gebührengesetz 1957 (Fees Act 1957).

Legal bases

• sections 3, 15 to 18, 35, 61, 64, 77, 81 of the Strahlenschutzgesetz 2020
  (Radiation Protection Act 2020^{Unofficial English translation} – StrSchG 2020)
• sections 7, 9, 10, 25, 81, 118 of the Allgemeine Strahlenschutzverordnung 2020
  (General Radiation Protection Ordinance 2020^{Unofficial English translation} – AllgStrSchV 2020)

Expert information

No expert information is available.