Germany | BCH-DEC-DE-111631 | 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
6786-01-0095 (adv. 42010.0095); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum L.) DL10, DL11, DL12, DL13 and DC1, issued by the German Competent Authority
EN
27 Apr 1999
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
Yes
  • - Person: BAZ | BCH-CON-DE-101384-2
    Person
    BAZ
    , Institut für landwirtschaftliche Kulturen
    Erwin-Baur-Str. 27
    Quedlinburg,
    06484, Germany
    Phone: +49 (0)3946 47 701,
    Fax: +49 (0)3946 47 255,
    Email: zl@jki.bund.de,
    Related Organization
    Bundesanstalt für Züchtungsforschung an Kulturpflanzen (BAZ)
    Academic or research institute
    Erwin-Baur-Str. 27
    Quedlinburg,
    06484, Germany
    Phone: +49 (0)3946 47 701,
    Fax: +49 (0)3946 47 255,
    Email: zl@jki.bund.de,
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 kept separately from non transgenic plant material.
-  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 spring of following year, the first 15 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.
-  After the end of the field trial 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.
-  After the end of the field trial 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 90/220/EEC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-111611-1 Living Modified Organism Potato modified for a tolerance against bacterial pathogens
    BAZ Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Bacteria
  • BCH-RA-DE-111630-3 Risk Assessment generated by a regulatory process 6786-01-0095 (adv. 42010.0095); Summary of the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum L.), DL10, DL11, DL12, DL13 and DC1, issued by the German Competent Authority
    Potato modified for a tolerance against bacterial pathogens | Resistance to diseases and pests, Resistance to antibiotics
Document on the decision, communication, notification or declaration
Additional Information
-  type of decision: field trial
-  LMO:  DL10, DL11, DL12, DL13 and DC1
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 27 April 1999 to 31 December 2001
-  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: 3 ha/site/year
-  max. 4000 LMO/site

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/99/95 

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)