Procedure descriptions
Applying for a licence for the construction and operation of genetic engineering facilities
Genetic engineering comprises molecular biological methods for the targeted modification of genetic material. The handling of genetic engineering is governed by the Genetic Engineering Act (GenTG) and the associated ordinances, including the Genetic Engineering Safety Ordinance (GenTSV). Genetic engineering work is categorised into the four safety levels S1 to S4 according to its risk potential for human health and the environment. The overall risk assessment is based on the interaction of the properties of the following individual components in accordance with the criteria in Annex 1 of the GenTSV:
- Donor organism and nucleic acid segment intended for transfer,
- Recipient organism,
- Vectors (genetic engineering tools used to introduce foreign genetic material into a cell; these can be viruses, phages or plasmids),
- the resulting genetically modified organism (GMO).
Genetic engineering facilities of safety levels S1 to S4 are facilities in which genetic engineering work is carried out in a closed system in order to limit the contact of the organisms used with humans and the environment and to ensure a level of safety appropriate to the risk potential. For this purpose, genetic engineering facilities are equipped with different safety measures depending on the safety level, which are prescribed in Annexes 2 to 4 of the GenTSV.
As the operator of a genetic engineering facility, you must notify, register or obtain authorisation from the competent authority for the construction and operation of the facility as well as other genetic engineering work, depending on the safety level. There are corresponding application forms for this purpose. The competent authority will confirm receipt of your documents. In addition to the construction of a genetic engineering facility, every significant change to the facility is also subject to an official procedure corresponding to the safety level. Significant changes generally include changes to the scope or mode of operation of a genetic engineering facility. Whether the procedure involves notification, registration or authorisation depends on the safety level to which the planned genetic engineering work falls.
Responsible authority
The regional council in Tübingen is responsible for the entire state.
Regierungspräsidium Tübingen
Contact
Details
Prerequisite
- Reliability of the operator and other responsible persons (Project Manager (PL) and Biological Safety Officer (BBS)),
- Expertise of the above-mentioned persons,
- Fulfilment of duties,
- Risk assessment, safety classification and appropriate precautions so that no harmful effects on humans and the environment (Section 1 (1) GenTG) are to be expected,
- other regulations under public law and occupational health and safety concerns do not prevent the construction and operation of the genetic engineering facility.
Procedure
As the operator, depending on the safety level, you must notify the Department 57 - Genetic Engineering Supervision at the Regional Council of Tübingen or submit an application for authorisation before setting up and operating the genetic engineering facility. You will receive confirmation of receipt of your documents. Your documents will then be checked for completeness. Subsequent requests for missing documents and information may be made. It may be necessary to involve the Central Commission for Biological Safety (ZKBS) in the assessment of the genetic engineering work and the safety requirements for the genetic engineering facility. Once the opinion of the ZKBS has been received and processing has been completed, a corresponding decision will be issued depending on the procedure.
Deadlines
As the operator, you must notify, register or obtain authorisation from Department 57 - Genetic Engineering Supervision before setting up and operating the genetic engineering facility. The deadlines until the start of operation and genetic engineering work depend on the procedure.
The processing time depends on the procedure and the completeness of the documents. The deadlines are interrupted in the event of subsequent requests or involvement of the ZKBS.
Required documents
The procedure requires a written application. You must enclose all documents required for notification, registration or authorisation. This includes the relevant forms, as well as a site and room plan, operating instructions and a hygiene plan. Current forms for the various procedures can be found in the collection of forms of Department 57 - Genetic Engineering Supervision.
Costs
Any fees incurred are determined by the Fee Ordinance of the Baden-Württemberg Ministry of the Environment and depend on the amount of work involved.
Miscellaneous
If you have any further questions or require advice, please contact your regional contact person.
It is advisable to get in touch with the contact persons in advance and seek advice.
Legal basis
Gesetz zur Regelung der Gentechnik (Gentechnikgesetz – GenTG):
- § 8 Genehmigung, Anzeige und Anmeldung von gentechnischen Anlagen und erstmaligen gentechnischen Arbeiten
- § 9 Weitere gentechnische Arbeiten
- § 10 Genehmigungsverfahren
- § 11 Genehmigungsvoraussetzungen
- § 12 Anzeige- und Anmeldeverfahren
- Anlage 1 Allgemeine Kriterien für die Risikobewertung
- Anlage 2 Sicherheitsmaßnahmen für Labor- und für Produktionsbereiche
- Anlage 3 Sicherheitsmaßnahmen für Gewächshäuser
- Anlage 4 Sicherheitsmaßnahmen für Tierräume
Release note
Machine generated, based on the German release by: Umweltministerium Baden-Württemberg, 28.07.2025
Contact
Bürger- und Standesamt (Bürgeramt)
eMail buergeramt@heidenheim.de
Telefon (0 73 21) 3 27-33 42
Fax (0 73 21) 3 23-33 32