Germany | BCH-LAW-DE-262234 | Biosafety Law, Regulation, Guidelines and Agreements | Biosafety Clearing-House

BCH-LAW-DE-262234-1   |   PDF   |   Print   |  

Biosafety Law, Regulation, Guidelines and Agreements (LAW)

last updated: 01 Nov 2022
General Information
Position statement of the ZKBS on the classification of genetic engineering operations, in which genes for immunomodulating proteins are inserted into the genome of replication-competent microorganisms
Legislative details
National / Federal
Due to their pleiotropic and redundant mode of function as well as the strong context dependence of their properties, immunomodulatory proteins, such as cytokines or chemokines, can sometimes exert opposite effects on certain immune responses, i.e. either stimulate or suppress the defence against a pathogen.
For genetic engineering work in which immunomodulating proteins are expressed by replication-competent microorganisms, a statement about the mode of action of these proteins cannot be made on the basis of general criteria. Thus, a case-by-case evaluation of genetic engineering work in which genes for immunomodulatory proteins are inserted into the genome of replication-competent microorganisms is fundamentally required by the ZKBS. 
01 Feb 2022
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.