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Law, Regulation or Guideline
Record information and status
Record ID
Date of creation
2021-06-08 09:37 UTC (german_bch@bvl.bund.de)
Date of publication
2021-06-08 17:28 UTC (nina.opitz@bmel.bund.de)

This document is also available in the following languages:
General Information
  • Germany
  • Germany
Title of document
Statement of the ZKBS on the suitability of Escherichia coli K12-derived strains as part of biological safety measures according to § 8 para. 1 GenTSV
Legislative details
Type of document
  • Guidelines
Subject areas
  • Contained use
  • biological safety measures
Types of LMOs addressed
  • Bacteria
Brief description of the document including objective and scope:
This general statement of the Central Committee on Biological Safety (Zentrale Kommission für die Biologische Sicherheit (ZKBS)) examines, on the occasion of the entry into force of the amendment to the Genetic Engineering Safety Regulation (GenTSV) in March 2021, whether strains derived from the original Escherichia coli K-12 isolate (E. coli K12-derived strains) can be recognised as part of biological safety measures (here: vector and recipient systems). E. coli K12-derived strains have been recognised as a biological safety measure (recipient organism) since 1978.  In the decades of widespread use, they have proven to be safe without exception. Section 8 para. 1 of the amended GenTSV specifies the requirements that must be met in order for E. coli K12-derived strains to continue to be recognised as biological safety measures:
1. a scientific description and a taxonomic classification of the recipient organism must be available,
2. the recipient organism is not pathogenic to humans, animals or plants and does not exhibit environmentally hazardous properties,
3. the recipient organism can only be propagated under conditions that are rarely or never encountered outside genetic engineering facilities, and
4. the recipient organism engages in only minimal horizontal gene exchange with other species.

After consideration of these four criteria, the ZKBS recognises those E. coli K12-derived strains as part of a biosafety measure in which neither conjugative plasmids with wide host range and ability to mobilise nor generally transducing prophages with wide host range are present. Information on whether individual E. coli K12-derived strains are suitable as biosafety recipient strains according to the criteria set out in this statement will be collected and made available in the Biosafety Recipient Strain Database (see under Other relevant website address or attached documents), which is maintained by the ZKBS administrative office.

Information on the GenTSV is provided in BCH record #40587.
Date of entry into force
Document details
Document text
45270_E coli K12-abgeleitete Stämme als Teil biol Sicherheitsmaßnahmen_2021_de.pdf (188 KB)
45270 - Allgemeine Stellungnahme der Zentralen Kommission für die Biologische Sicherheit (ZKBS) zur Eignung von Escherichia coli K12-abgeleiteten Stämmen als Teil biologischer Sicherheitsmaßnahmen gemäß § 8 Absatz 1 GenTSV (German language)
45270_E coli K12-derived strains as part of biological safety measures_2021_en.pdf (186 KB)
45270_E coli K12-derived strains as part of biological safety measures_2021_en.pdf
Information about document text
A PDF of the statement of the ZKBS can be obtained at the ZKBS webpage; the respective link is provided under `Other relevant website address or attached documents´.
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 on Biological Safety (ZKBS - Zentrale Kommission für die Biologische Sicherheit) 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 - Bundesamt für Verbraucherschutz und Lebensmittelsicherheit). Its members and deputy members are appointed by the Federal Ministry for Food and Agriculture and (BMEL - Bundesministerium für Ernährung und Landwirtschaft) for three years. The ZKBS evaluates genetically modified organisms (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.