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Biosafety Law, Regulation, Guidelines and Agreements
(LAW)
published: 01 Nov 2022
last updated: 01 Jun 2026
No
Position statement of the ZKBS on the classification of genetic engineering operations, in which nucleic acid fragments with immunomodulatory potential are inserted into the genome of replication-competent microorganisms
EN
Guidelines
National / Federal
Due to their pleiotropic and redundant mode of function as well as the strong context dependence of their properties, immunomodulatory proteins, such as cytokines or chemokines, can sometimes exert opposite effects on certain immune responses, i.e. either stimulate or suppress the defence against a pathogen.
For genetic engineering work in which nucleic acid fragments with immunomodulatory potential are inserted in replication-competent microorganisms, a statement about the impact on the hazard potential cannot be made on the basis of general criteria. Thus, a case-by-case evaluation of these genetic engineering work is required by the ZKBS. Exceptions, where a case-by-case evaluation for genetic engineering work with nucleic acid fragments with immunomodulatory potential is not necessary, are stated in this general statement.
03 Feb 2026
The Central Committee on Biological Safety (ZKBS – Zentrale Kommission für die Biologische Sicherheit) is an expert scientific committee made up of 20 members and 20 deputy members, who represent different specialist areas or spheres of corporate interest. Its offices are based at the Federal Office of Consumer Protection and Food Safety (BVL – Bundesamt für Verbraucherschutz und Lebensmittelsicherheit). Its members and deputy members are appointed by the Federal Ministry of Agriculture, Food and Regional Identity (BMLEH – Bundesministerium für Landwirtschaft, Ernährung und Heimat) for three years. The ZKBS evaluates genetically modified organisms (GMOs) for possible risk potential, assigns genetic engineering operations to a biosafety level and recommends suitable safety measures. The German federal states obtain ZKBS position statements for genetic engineering operations in safety categories 3 and 4 and for operations in a lower safety category, whose classification is not clear. The ZKBS also evaluates approval applications for releases and for the placing of GMOs on the market and also issues a report to the BVL. An activity report is published annually.
- Internetseiten der ZKBS [ German ]
- Homepage of the ZKBS [ English ]
