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Law, Regulation or Guideline
Record information and status
Record ID
Date of creation
2018-06-26 11:32 UTC (german_bch@bvl.bund.de)
Date of last update
2018-07-13 07:37 UTC (german_bch@bvl.bund.de)
Date of publication
2018-07-13 07:56 UTC (ursula.monnerjahn@bmel.bund.de)

This document is also available in the following languages:
General Information
  • Germany
  • Germany
Title of document
Synthetic Biology 2nd Interim Report of the German Central Committee on Biological Safety (ZKBS)
Legislative details
Type of document
  • Regulatory summary / national biosafety framework
Subject areas
  • Public awareness and participation
  • Risk assessment and management
Types of LMOs addressed
  • All types of organisms
Brief description of the document including objective and scope:
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.
Date of entry into force
Document details
Document text
ZKBS-Bericht SynBio_2018.pdf (1 MB)
Synthetic Biology 2nd Interim Report of the German Central Committee on Biological Safety
Regulatory contact information
Contact person
Federal Office of Consumer Protection and Food Safety
Mauerstrasse 39-42
Germany, 10117
Url:http://www.biosafety-bch.de (english language),BVL Homepage (English)
Additional 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.