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Biosafety Law, Regulation, Guidelines and Agreements
(LAW)
published: 11 Aug 2016
last updated: 14 Oct 2026
No
Monitoring of Synthetic Biology in Germany 1st Report of the Central Committee on Biological Safety
EN
Regulatory summary / National Biosafety Framework
Synthetic Biology is a research field that is associated with high expectations, but also with some concerns among the public. The ZKBS was entrusted with a monitoring regarding this subject.
Synthetic Biology aims to design biological units, such as enzymes, genetic circuits or cells, in a way they do not occur in nature. The main difference to conventional genetic engineering consists in the further development of molecular biological methods enabling significantly more extensive manipulations, the largescale use of bioinformatics enabling a modelled approach and the efforts to enhance the predictability of these manipulations via standardised components.
The present report briefly introduces the research field and provides a representative overview of the research activities in the field of synthetic biology in Germany. Furthermore, the presented subfields of Synthetic Biology are examined to determine whether they involve any risks to biological safety and whether the research projects are covered by the scope of the GenTG [Genetic Engineering Act], the German national law implementing directives 2009/41/EC on contained use of GMO microorganisms.
Synthetic Biology aims to design biological units, such as enzymes, genetic circuits or cells, in a way they do not occur in nature. The main difference to conventional genetic engineering consists in the further development of molecular biological methods enabling significantly more extensive manipulations, the largescale use of bioinformatics enabling a modelled approach and the efforts to enhance the predictability of these manipulations via standardised components.
The present report briefly introduces the research field and provides a representative overview of the research activities in the field of synthetic biology in Germany. Furthermore, the presented subfields of Synthetic Biology are examined to determine whether they involve any risks to biological safety and whether the research projects are covered by the scope of the GenTG [Genetic Engineering Act], the German national law implementing directives 2009/41/EC on contained use of GMO microorganisms.
01 Nov 2012
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.
- ZKBS Homepage [ English ]
- Internetseite der ZKBS [ German ]
