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Biosafety Law, Regulation, Guidelines and Agreements
(LAW)
last updated: 27 Feb 2025
No
Position Statement of the ZKBS on the suitability of established laboratory strains of Komagataella phaffii as part of biological safety measures according to § 8 para. 1 GenTSV
EN
Guidelines
National / Federal
This general statement of the Central Committee on Biological Safety (Zentrale Kommission für die Biologische Sicherheit (ZKBS)) examines whether established laboratory strains of Komagataella phaffii (NRRL Y-11430 and NCYC 2543, including derivatives) can be recognized as part of biological safety measures (here: vector and recipient systems).
Section 8 para. 1 of the amended GenTSV specifies the requirements that must be met in order for established laboratory strains of Komagataella phaffii to be recognized 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.
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 recognizes established laboratory strains of Komagataella phaffii (NRRL Y-11430 and NCYC 2543, including derivatives) as part of a biological safety measure.
Information on the GenTSV is provided in BCH record #40587.
01 Feb 2025
Section 8, paragraph 1 of the amended GenTSV sets out the requirements for the approval of recipient organisms as part of biological safety measures.
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.
- Biosafety recipient strain database (german language only) [ English ]
- Datenbank der Empfängerstämme für biologische Sicherheitsmaßnahmen [ German ]
- ZKBS Homepage [ English ]
- Internetseite der ZKBS [ German ]
