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Leyes, reglamentos, directrices y acuerdos en materia de seguridad de la biotecnología
(LAW)
published: 01 nov. 2022
last updated: 05 feb. 2025
No
Statement of the ZKBS on risk assessment of Adeno-associated viruses from primates and vectors derived therefrom
EN
Directrices
Nacional / Federal
Adeno-associated viruses (AAVs) are ubiquitously distributed in a variety of animals and humans, with a very narrow host range of individual serotypes. As a subgroup of the defective viruses (genus Dependoparvovirus), they belong to the family Parvoviridae.
According to Art. 5 Paragraph 6 of the German Genetic Engineering Safety Regulation (GenTSV), AAVs are assigned to risk group 1 as a donor or recipient organism for genetic engineering operations. The statement also provides an overview of AAV-derived vector systems and the criteria for their risk assessment.
According to Art. 5 Paragraph 6 of the German Genetic Engineering Safety Regulation (GenTSV), AAVs are assigned to risk group 1 as a donor or recipient organism for genetic engineering operations. The statement also provides an overview of AAV-derived vector systems and the criteria for their risk assessment.
01 nov. 2024
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.
- Internetseiten der ZKBS [ Alemán ]
- Homepage of the ZKBS [ English ]