Germany | BCH-LAW-DE-262242 | Biosafety Law, Regulation, Guidelines and Agreements | Biosafety Clearing-House

BCH-LAW-DE-262242-1   |   PDF   |   Print   |  

Biosafety Law, Regulation, Guidelines and Agreements (LAW)

last updated: 01 Nov 2022
General Information
Position statement of the ZKBS on the risk assessment of the recombinant vaccinia virus MVA
Legislative details
National / Federal
The modified vaccinia virus Ankara (MVA) arose from the wild-type vaccinia virus Ankara (CVA, risk group 2). Numerous mutations occurred in the genome of MVA and six large deletions totaling 31 kbp were created. MVA exhibits a highly attenuated phenotype and was assigned to risk group 1.
In this statement, the ZKBS gives recommendations for the risk assessment of recombinant MVA. The allocation of rMVA to risk groups is based on the hazard potential of the transferred nucleic acid segments. 
01 Nov 2018
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.