Germany | BCH-LAW-DE-262232 | Biosafety Law, Regulation, Guidelines and Agreements | Biosafety Clearing-House

Loading...
  |  
BCH-LAW-DE-262232-1   |   PDF   |   Print   |  

Biosafety Law, Regulation, Guidelines and Agreements (LAW)

last updated: 01 Nov 2022
Amendment
No
General Information
Recommendation of the ZKBS on the risk assessment of Middle East respiratory syndrome-related coronavirus as donor or recipient organism according to Article 5 paragraph 1 GenTSV
EN
Legislative details
Guidelines
National / Federal
The Middle East respiratory syndrome-related coronavirus (MERS-CoV) is assigned to the family Coronaviridae. MERS-CoV causes severe respiratory diseases in humans with a mortality rate of 35 %.
According to Article 5 paragraph 1 GenTSV in conjunction with the criteria in Annex I GenTSV, Middle East respiratory syndrome-related coronavirus is assigned to risk group 3 as donor and recipient organism for genetic engineering operations.
EN
01 Jan 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. 
Loading...