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Biosafety Law, Regulation, Guidelines and Agreements (LAW)
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BCH-LAW-DE-103673-3   |   PDF   |   Print   |  
published: 06 Jul 2012 last updated: 14 Apr 2022
Amendment
No
General Information
Position statement of the Central Committee on Biological Safety (ZKBS) on the risk assessment of influenza viruses
EN
Legislative details
Guidelines
National / Federal
Position statement of the Central Committee on Biological Safety (ZKBS) on the risk assessment of influenza viruses. In general, Directive 2000/54/EC of the European Parliament and the Council allocates influenza viruses (genus A, B and C) to risk group 2. Contrarily, the ZKBS recommends to assign the following subtypes and strains of influenza-A-viruses to risk group 3 since these are associated with a severe course of disease in humans or fowl, or with an increased pandemic potential due to the lack of immunity in the population:
- the variant of subtype H1N1 that caused the Spanish Flu in 1918
- highly pathogenic avian influenza viruses (HPAIV)
- novel avian influenza A virus of subtype H7N9
- non-contemporary influenza A viruses of the subtype H2N2
Moreover, the ZKBS recommends some additional safety measures for genetic engineering operations with these viruses.
EN
30 Nov 2015
Document details
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 office is 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, agriculture and Consumer Protection (BMELV) 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.