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Biosafety Law, Regulation, Guidelines and Agreements (LAW)

last updated: 27 May 2022
General information
Synthetic Biology 2nd Interim Report of the German Central Committee on Biological Safety (ZKBS)
Legislative details
Regulatory summary / National Biosafety Framework
National / Federal
In this second report on Synthetic Biology, the Central Committee on Biological Safety (ZKBS) summarizes recent activities and the most important developments in Synthetic Biology research worldwide and conducts an assessment on whether these activities and their products pose a threat for biological safety. It shall serve as a basis for ongoing, continuous monitoring of advancements in Synthetic Biology.
The different subfields of Synthetic Biology are analyzed separately with a special focus on essentially two questions:
- Does the respective subfield pose potential risks to biosafety?
- Are the current risk assessment methods for GMOs in Germany/ the European Union applicable or are new specific regulations for one or more of the subfields needed?
The report is addressed to the German Federal Ministry of Food and Agriculture as well as to other risk assessors and interested stakeholders. It assesses Synthetic Biology in the first place on the basis of the German GenTG, which is an implementation of the European Directives 2001/18/EC and 2009/41/EC. The conclusions drawn are thus likely to be valid for the European regulations as well.
26 Jun 2018
Regulatory contact information
Additional Information
The Central Committee of 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 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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