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Biosafety Law, Regulation, Guidelines and Agreements
(LAW)
last updated: 21 Jan 2026
No
Position statement of the ZKBS on the risk assessment of genetically modified baculoviruses according to § 5 paragraph 1 GenTSV
EN
Guidelines
National / Federal
This position statement by the Central Committee on Biological Safety (ZKBS) is dedicated to the risk assessment of genetically modified baculoviruses.
Baculoviruses are generally classified as donor and recipient organisms for genetic engineering work in risk group 1 in accordance with § 5 (1) and (6) in conjunction with Annex 1 No. 1 GenTSV.
Baculoviruses are generally classified as donor and recipient organisms for genetic engineering work in risk group 1 in accordance with § 5 (1) and (6) in conjunction with Annex 1 No. 1 GenTSV.
However, the risk potential of genetically modified baculoviruses may be increased as a result of a genetic modification. The risk potential of genetically modified baculoviruses is determined by the hazard potential of the inserted genes and by the host range of the viruses, defined by the unmodified or pseudotyped envelope. If the baculoviruses encode a gene with hazard potential for insects under the control of an insect-specific promoter, the risk potential also depends on the presence of the baculoviral virulence factor genes chiA, v-cath, p10 and ph.
In this statement, the ZKBS now defines the criteria according to which genetically modified baculoviruses are allocated to risk group 1 or 2 and in which cases an individual case assessment by the ZKBS is necessary.
In this statement, the ZKBS now defines the criteria according to which genetically modified baculoviruses are allocated to risk group 1 or 2 and in which cases an individual case assessment by the ZKBS is necessary.
In addition, the ZKBS recommends additional safety measures when handling baculoviral vectors that transfer genes with neoplastic transforming potential.
01 Jul 2025
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 the Federal Ministry for 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 ]
- ZKBS Homepage [ English ]
