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Country's Decision or any other Communication (DEC)
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BCH-DEC-DE-110682-4   |   PDF   |   Print   |  
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published: 13 Jul 2016 last updated: 15 Mar 2024
Amendment
No
General Information
6786-01-0150 (adv. 42010.0150); Decision regarding the risk assessment of a deliberate release (field trial) of the genetically modified potato (Solanum tuberosum L.) B33-LegHg-3'OCS 13, B33-LegHg-3'OCS 45, B33-LegHg-3'OCS 54 and B33-LegHg-3'OCS 57, issued by the German Competent Authority
EN
18 Mar 2004
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 plant material has to be transported and stored in closed and clearly labelled repositories at any time outside the release site and laboratory and has to be keept separately from non transgenic plant material. The label needs to distinctively describe the LMO and it needs to be noted that this potato is unfit for consumption (food and feed). All remaining fertile plant material has to be destroyed by disruption of their germination capacity.
- Inspection of the release site on unexpected biological traits of the LMO and reciprocal effects between LMO and other organisms has to be accomplished regularly, at least once every four weeks, during the experimental release.
-   Monthly inspection of the surrounding area (10 m) of the release site for transgenic potato volunteers and their removal and disposal.
-  After harvest the first 15-20 cm of upper soil of the release site have to be loosen up. Potato tubers that emerge during that procedure have to be manually collected, removed, and destroyed by disruption of their germination capacity (steaming or autoclaving).
- After completion of the field trial monthly inspection of release site and surrounding areas (10 m) for transgenic potato volunteers, their documentation and removal and disposal has to be accomplished for one year, or longer if volunteers were observed. No plant species must be cultivated on the release site that impairs the detection of transgenic potato volunteers.
-     A distance of no less than 10 m to other release sites with potatos has to be kept.
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-110680-2 Living Modified Organism Potato modified for increased oxygen supply to tubers
    Max Planck Institute of Molecular Plant Physiology(MPIMP) | Changes in quality and/or metabolite content (Carbohydrates), Resistance to antibiotics (Kanamycin)
  • BCH-RA-DE-110681-3 Risk Assessment generated by a regulatory process 6786-01-0150 (adv. 42010.0150); Summary of the risk assessment of a deliberate release (field trial) of the genetically modified potato (Solanum tuberosum L.) B33-LegHg-3'OCS 13, B33-LegHg-3'OCS 45, B33-LegHg-3'OCS 54 and B33-LegHg-3'OCS 57, issued by the German Competent Authority
    Potato modified for increased oxygen supply to tubers | Potato, SOLTU, Resistance to antibiotics, Changes in quality and/or metabolite content
Document on the decision, communication, notification or declaration
Additional Information
-  type of decision: field trial
-  LMO: B33-LegHg-3‘OCS 13, B33-LegHg-3‘OCS 45, B33-LegHg-3‘OCS 54 and B33-LegHg-3‘OCS 57
-  legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 18 March 2004 to 31 December 2008
-  locations: 1 experimental field located in 1 village in Germany; for details see German LMO/GMO location register (http://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
-  size: 620 m²/site/year
-  max. 800 LMO/site
EN