Germany | BCH-LAW-DE-261456 | Biosafety Law, Regulation, Guidelines and Agreements | Biosafety Clearing-House

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BCH-LAW-DE-261456-2   |   PDF   |   Print   |  

Biosafety Law, Regulation, Guidelines and Agreements (LAW)

last updated: 17 Nov 2022
Amendment
No
General Information
General statement of the ZKBS on genetic engineering work carried out frequently with the underlying criteria of comparability: Genetic engineering work with RNA viruses derived from Minigenomes, replicons and virus-like particles for introduction into human or animal cells
EN
Legislative details
Guidelines
National / Federal
This ZKBS statement describes various systems for the production of viral minigenomes, viral replicons and virus-like particles derived from RNA viruses. These systems are intended to be introduced into human or animal cells and to be able to study the RNA viruses without having to work with the often very pathogenic wild-type viruses themselves.
The replication-defective systems each represent only individual aspects of the viral life cycle; infectious viruses are not produced in the process, which is why it is possible to work with these systems with significantly reduced safety measures.
The statement summarises the relevant criteria for the safety classification of genetic engineering work with viral minigenomes, viral replicons and virus-like particles and then specifically names criteria that enable a safety classification of genetic engineering work based on comparability.
EN
01 Feb 2021
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. 
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