Germany | BCH-LAW-DE-262400 | Biosafety Law, Regulation, Guidelines and Agreements | Biosafety Clearing-House

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Biosafety Law, Regulation, Guidelines and Agreements (LAW)

last updated: 17 Nov 2022
Amendment
No
General Information
General position statement of the ZKBS on frequently carried out genetic engineering operations based on the criteria of comparability: Gene transfer with mastadenoviruses from primates
EN
Legislative details
Guidelines
National / Federal
This general statement of the ZKBS describes the adenoviral system and provides a summary of the relevant criteria for the safety classification of genetic engineering work with adenoviral vectors. In addition, general criteria of comparability for genetic engineering work with adenoviral vector particles are summarized.
EN
01 Apr 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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