Germany | BCH-DEC-DE-111113 | Country's Decision or any other Communication | Biosafety Clearing-House

Loading...
  |  

Country's Decision or any other Communication (DEC)

last updated: 05 Nov 2020
Amendment
No
General information
6786-01-0127 (adv. 42010.0127); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum L.), lines VR/T18; VR/T21; VR/T23 and amf/T85; amf/T103; amf/T121, issued by the German Competent Authority
EN
18 Sep 2002
Yes
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 keep separately from non transgenic plant material.
-  The field site needs to be labeled, stating that this potato is unfit for consumption.
-  All remaining fertile plant material has to be destroyed by disruption of their germination capacity.
-  All machines that have been used on the release site have to be thoroughly cleaned on the release site.
-  After harvest and in the following year, the first 15 - 20 cm of upper soil of the release site have to be loosened up. Potato tubers that emerge during that procedure have to be manually collected, removed, and destroyed by disruption of their germination capacity.
-  Following the deliberate release, the release site must be inspected for transgenic volunteer potatos at least once every four weeks. The inspection period has to be extended for another year if potato volunteers were observed. No plant species must be cultivated on the release site that impairs the detection of transgenic potato 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-111084-1 Living Modified Organism Potato modified for Potato Leaf Roll Virus resistance
    MPIPZ Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Viruses - Potato leaf roll virus (PLRV), Potato virus Y (PVY)
  • BCH-LMO-SCBD-111080-1 Living Modified Organism Potato modified for altered amylose content
    MPIPZ altered carbohydrate composition: increased amylopectin content Resistance to antibiotics - Kanamycin
  • BCH-RA-DE-111112-3 Risk Assessment generated by a regulatory process 6786-01-0127 (adv. 42010.0127); Summary of the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum L.), lines VR/T18; VR/T21; VR/T23 and amf/T85; amf/T103; amf/T121, issued by the German Competent Authority
    Potato modified for altered amylose content | Resistance to antibiotics, Changes in quality and/or metabolite content | Potato modified for Potato Leaf Roll Virus resistance | Resistance to diseases and pests, Resistance to antibiotics
Document on the decision, communication, notification or declaration
Additional Information
-  type of decision: field trial
-  LMO: lines VR/T18; VR/T21; VR/T23 and amf/T85; amf/T103; amf/T121
-  legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 18 September 2002 to 31 December 2003
-  locations: 1 experimental field located in 1 village in Germany, for details refer to the German LMO/GMO location register (https://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
-  size: 5000 m²/site/year
-  max. 1500 LMO/site/year

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/01/127

The decision on this deliberate release was made by the Robert Koch Institute (RKI).
The RKI was the competent national authority for the German Gene Technology Act before the competences were transferred to the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL) on April 1st 2004. Deliberate releases that were authorized by the RKI prior to this date are now handled by the BVL.
Records referencing this document Show in search
Record type Field Record(s)