Loading...
Country's Decision or any other Communication (DEC)
  |  
BCH-DEC-DE-103120-4   |   PDF   |   Print   |  
published: 20 Feb 2012 last updated: 03 Jan 2024
Amendment
No
General Information
6786-01-0176 (adv. 42010.0176); Decision regarding the deliberate release (field trial) of genetically modified potatoes (Solanum tuberosum, varieties Albatros and Desirée) VP60, PsbY-cyeI, 35SctxBSEK and 35S-nptII, issued by the German Competent Authority
EN
21 Nov 2005
No
Subject of the decision, notification, communication or declaration
  • Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)
LMOs for intentional introduction into the environment
No
No
Yes
No
No
Result of the decision
Approval of the import and/or use of the LMO(s) with conditions
- Fertile genetically modified plant material has to be stored in closed and clearly labelled repositories for transport and storage at any time outside the release site and laboratory. On the labels it needs to be noted that these potatoes are unfit for consumption. Remaining potato tubers have to be disposed by chopping, squeezing or autoclaving.
- To prevent entering of the release site by wild animals (including rabbits) a fence has to surround the release site.
- Inspection of the release site on unexpected biological traits of the LMO and reciprocal effects between LMO and other organism has to be accomplished weekly during the experimental release and monthly after the experimental release.
- Monthly inspection of the surrounding area [20 m] of the release site for transgenic potato volunteers and their removal and disposal.
- After completion of the field trial the soil needs to be loosen up to uncover remaining potato tubers in the field site which have to be removed and disposed.
- Machines that have been in contact with LMOs have to be cleaned after use.
- After completion of the field trial an inspection of the release site and the surrounding area for transgenic potato volunteers, their documentation and removal and disposal has to be accomplished monthly for one year. if volunteers were observed the inspection period has to be extended for another year. Thereby the release site must not be cultivated with plants impairing the detection of transgenic volunteers.
EN
To comply with requirements of Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-102032-8 Living Modified Organism Potato modified for the expression of synthetic VP60 for vaccine production against RHDV
    University of Rostock | Production of medical or pharmaceutical compounds (human or animal) (Vaccines), Resistance to antibiotics (Kanamycin)
  • BCH-LMO-SCBD-103103-4 Living Modified Organism Potato producing vaccine against cholera
    University of Rostock | Production of medical or pharmaceutical compounds (human or animal) (Vaccines), Resistance to antibiotics (Kanamycin)
  • BCH-LMO-SCBD-103098-6 Living Modified Organism Potato synthesizing cyanophycin biopolymer
    University of Rostock | Resistance to antibiotics (Kanamycin, Neomycin), Use in industrial applications
  • BCH-LMO-SCBD-103099-4 Living Modified Organism Potato resistant to aminoglycoside antibiotics
    University of Rostock | Resistance to antibiotics (Kanamycin, Neomycin)
  • BCH-RA-DE-103118-4 Risk Assessment generated by a regulatory process 6786-01-0176 (adv. 42010.0176); Summary of the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum, varieties Albatros and Desirée) VP60, PsbY-cyeI, 35SctxBSEK and 35S-nptII, issued by the German Competent Authority
    Potato modified for the expression of synthetic VP60 for vaccine production against RHDV | Potato, SOLTU, Resistance to antibiotics, Production of medical or pharmaceutical compounds (human or animal) | Potato resistant to aminoglycoside antibiotics | Potato, SOLTU, Resistance to antibiotics | Potato producing vaccine against cholera | Potato, SOLTU, Resistance to antibiotics, Production of medical or pharmaceutical compounds (human or animal) | Potato synthesizing cyanophycin biopolymer | Potato, SOLTU, Resistance to antibiotics, Use in industrial applications
Document on the decision, communication, notification or declaration
Additional Information
type of decision: field trial
LMO: VP60, PsbY-cyeI, 35SctxBSEK and 35S-nptII
legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
scope: test of field performance of LMO
authorization valid within the vegetation periods of the years 2006, 2007 and 2008
locations: One experimental field in Germany; for details see German LMO/GMO location register (http://apps2.bvl.bund.de/stareg_web/showflaechen.do)
size: Including the surrounding area the release site covers 5,378 m² that contain 28 agricultural holdings of 3 x 3.6 m² each. Approximately 5 plants/m² will be planted

- There is a Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/05/176
EN