Germany | BCH-LAW-DE-262238 | Biosafety Law, Regulation, Guidelines and Agreements | Biosafety Clearing-House

BCH-LAW-DE-262238-1   |   PDF   |   Print   |  

Biosafety Law, Regulation, Guidelines and Agreements (LAW)

last updated: 01 Nov 2022
General Information
Recommendation of the ZKBS for the risk assessment of the recombinant Adenovirus ChAdOx1 nCoV-19 according to § 5 paragraph 1 GenTSV
Legislative details
National / Federal
The species Human mastadenovirus E includes several serotypes, including human adenovirus (Ad) 4, and is assigned to risk group 2. The isolate Chimpanzee adenovirus Y25 (ChAdY25) was isolated from chimpanzees and is closely related to human Ad4.
To produce the replication-defective vaccine vector, various deletions and mutations were made in ChAdY25. Finally, synthetically produced gene for the SARS-CoV-2 spike protein was introduced into the resulting vector ChAdOx1. According to § 5 paragraph 1 GenTSV in conjunction with the criteria in Annex I GenTSV, the recombinant adenovirus ChAdOx1 nCoV-19 is assigned to risk group 1 as a genetically modified organism.
01 Jul 2020
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.