Germany | BCH-LAW-DE-104465 | Biosafety Law, Regulation, Guidelines and Agreements | Biosafety Clearing-House

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Biosafety Law, Regulation, Guidelines and Agreements (LAW)
  |  
BCH-LAW-DE-104465-2   |   PDF   |   Print   |  
published: 27 Nov 2012 last updated: 23 Apr 2022
Amendment
No
General Information
Position statement of the ZKBS on classifying genetic engineering operations with primary cells from vertebrates
EN
Legislative details
Guidelines
National / Federal
Position statement of the German Central Commission of Biological Safety (ZKBS) on classifying genetic engineering operations with primary cells from vertebrates into risk groups depending on their origin according to German Genetic Engineering Act.
EN
01 May 2010
Regulatory contact information
Additional Information
The Central Biosafety Commission (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 offices are 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 for Food and Agriculture (BMEL – Bundesministerium für Ernährung und Landwirtschaft) 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.