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Notification of changes regarding the 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. To this end, 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 are obliged to submit notifications in accordance with Section 21 and Section 9 (4a) of the GenTG to Department 57 - Genetic Engineering Supervision at the Regional Council of Tübingen. The following notifications must be made:
- in advance of any change in the assignment of the project leader, the Biosafety Officer or a member of the Biosafety Committee,
- the cessation of operation of the genetic engineering facility,
- in advance of the intended modification of the safety-relevant facilities and precautions of a genetic engineering facility,
- immediately any incident that does not correspond to the expected course of the genetic engineering work or the release or placing on the market and which is suspected of jeopardising the legal interests specified in § 1 number 1 of the GenTG,
- new information on risks to human health or the environment without delay,
- in advance if genetic engineering work of safety levels S2 and S3 that has already been notified, registered or authorised is to be carried out in another of your already registered or authorised genetic engineering facilities.
Responsible authority
The Tübingen Regional Council is responsible for the entire state.
Details
Prerequisite
The requirements depend on the specific notifications to be made.
Procedure
As the operator, please inform your responsible contact person at Department 57 (Genetic Engineering Supervision) at the Regional Council of Tübingen of your planned changes. Depending on the change, you will receive confirmation of your notification.
If you report an incident that does not correspond to the expected course of genetic engineering work and where there is a suspicion of a hazard or if you receive new information about risks to human health or the environment, you will receive a confirmation of receipt and, if necessary, additional requests for information. If necessary, the Central Commission for Biological Safety must be informed by your contact persons.
Deadlines
You must submit the notification before implementing the planned change. The notification must be submitted immediately in the event of an incident that does not correspond to the expected course of the genetic engineering work and where there is a suspicion of a hazard or if new information on risks to human health or the environment is received.
Required documents
The required documents depend on the type of notification. These can be found in detail on Form E, which can be found in the collection of forms of the Tübingen Regional Council.
Costs
None, however, depending on the notification, there may be subsequent chargeable facts for which fees are levied in accordance with number 4 of the Ministry of the Environment's schedule of fees (GebVerZ UM).
Miscellaneous
If you have any further questions or require advice, please contact your regional contact person.
You can submit your notification informally, by e-mail or by using form E to your contact person.
Legal basis
Gesetz zur Regelung der Gentechnik (Gentechnikgesetz – GenTG):
- § 21 Mitteilungspflichten
- § 9 Absatz 4a Weitere gentechnische Arbeiten
Release note
Machine generated, based on the German release by: Umweltministerium Baden-Württemberg, 11.08.2025
