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Biosafety Law, Regulation, Guidelines and Agreements
(LAW)
last updated: 10 Sep 2026
No
ZKBS position statement on the risk assessment of viruses from bacteria and archaea as donor and recipient organisms and of propagated phage particles in phage preparations in accordance with § 5 (1) GenTSV
EN
Guidelines
National / Federal
In the position statement of the German Central Committee on Biological Safety (ZKBS) the risk of viruses from bacteria and archaea as donor and recipient organisms and of propagated phage particles in phage preparations is assessed in accordance with § 5 (1) of the German Genetic Engineering Act.
Bacteriophages (phages for short) continue to be classified in Risk Group 1 if their genome does not contain virulence factor genes. The decisive factor in the assessment of phage preparations is whether the phages are capable of general transduction and whether bacteria belonging to Risk Group 2 were used to propagate the phages.
Preparations of archaeal viruses are classified as Risk Group 1.
05 May 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.
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