Germany | BCH-LAW-DE-262239 | Biosafety Law, Regulation, Guidelines and Agreements | Biosafety Clearing-House

BCH-LAW-DE-262239-1   |   PDF   |   Print   |  

Biosafety Law, Regulation, Guidelines and Agreements (LAW)

last updated: 01 Nov 2022
General Information
Recommendation by the ZKBS on the risk assessment for Mammalian 1 orthobornavirus as a donor and recipient organism according to § 5 para. 1 GenTSV
Legislative details
National / Federal
The Mammalian 1 orthobornavirus (previously Borna disease virus, BoDV) is an enveloped virus of the Bornaviridae family (genus Orthobornavirus). BoDV is the pathogen of the so-called Borna disease in horses and sheep. According to current knowledge, the Mammalian 1 orthobornavirus can also cause severe encephalitis in humans, which can lead to death. However, many years of experience in handling BoDV in laboratories show that level 2 safety measures sufficiently counteract the risk of BoDV infection.
According to § 5 para. 1 GenTSV in conjunction with the criteria in annex I GenTSV, Mammalian 1 orthobornavirus is further assigned to risk group 2 as a donor and recipient organism for genetic engineering operations. 
01 Feb 2019
Regulatory contact information
Additional Information
The Central Committee on 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.