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.