Germany | BCH-LAW-DE-262240 | Biosafety Law, Regulation, Guidelines and Agreements | Biosafety Clearing-House

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Biosafety Law, Regulation, Guidelines and Agreements (LAW)

last updated: 01 Nov 2022
Amendment
No
General Information
Recommendation by the ZKBS on the risk assessment of poliovirus as a donor or recipient organism according to § 5 para. 1 GenTSV
EN
Legislative details
Guidelines
National / Federal
Poliovirus (PV) is the causative agent of the long-known disease poliomyelitis, also called polio. The virus belongs to the Picornaviridae family and is assigned to the Enterovirus C species. Three serotypes are distinguished. A well effective vaccination is available. The poliovirus has been assigned to risk group 2.
The World Health Organisation has set itself the goal of widespread PV eradication, which is why work with PV must be carried out under special safety precautions and, in the long term, there are plans to upgrade all PV serotypes to risk group 3.
The current classification of the ZKBS assigns the poliovirus serotypes 1 and 3 as donor and recipient organisms for genetic engineering work to risk group 2. Poliovirus serotype 2 (wild-type and vaccine strains) was assigned to risk group 3
EN
01 Dec 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. 
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