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Biosafety Law, Regulation, Guidelines and Agreements (LAW)
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BCH-LAW-DE-301358-1   |   PDF   |   Print   |  
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last updated: 07 Oct 2026
Amendment
No
General Information
Synthetic Biology 4th Report of the Central Committee on Biological Safety (ZKBS)
EN
Legislative details
Regulatory summary / National Biosafety Framework
National / Federal
In this fourth report on synthetic biology the Central Committee on Biological Safety (ZKBS) summarizes the publications from 2022 to 2025 in the individual research fields of synthetic biology. It comes to the concluding assessment that all research approaches considered here still fall under existing regulations, in particular the GenTG.
EN
01 Sep 2026
Regulatory contact information
Additional Information
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 office is 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.