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Biosafety Law, Regulation, Guidelines and Agreements (LAW)
BCH-LAW-DE-110745-2   |   PDF   |   Print   |  
published: 02 Aug 2016 last updated: 14 Apr 2022
General Information
Position statement of the ZKBS on the classification of genetic engineering operations for the production and use of higher organisms using recombinant gene drive systems
Legislative details
National / Federal
This position statement of the German Central Commission of Biological Safety (ZKBS) describes the latest scientific knowledge on the function of gene drive systems and provides advice on the safety assessment of such operations. This was initiated by of the extensive discussions and enquiries concerning their risk potential.
Gene drive systems are understood to be genetic elements or gene constructs that expedite their own spread in populations of sexually reproducing organisms by being inherited to more than 50% of the offspring. Because of their non-Mendelian inheritance, gene drive systems substantially differ from recombinant nucleic acid segments in genomes that are inherited conventionally. Gene drive systems can spread relatively rapidly in a population, even if they are associated with a selective disadvantage.
02 Feb 2016
Regulatory contact information
Additional Information
The Central Committee of Biological Safety (ZKBS) 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). Its members and deputy members are appointed by the Federal Ministry for Food and Agriculture (Bundesministerium für Ernährung und Landwirtschaft, BMEL)  for three years. The ZKBS evaluates 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.