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Country's Decision or any other Communication (DEC)
  |  
BCH-DEC-DE-110966-3   |   PDF   |   Print   |  
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published: 12 Sep 2016 last updated: 28 Oct 2020
Amendment
No
General Information
6786-01-0048 (adv. 42010.0048); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified Aspen (Populus tremula L. and P. tremula L. x P. tremuloides Michx.), different independent lines, issued by the German Competent Authority
EN
28 May 1996
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
- Prior to and during the flowering time, the field site has to be inspected twice a week for flowering aspen. Trees which are developing flower buds are to be removed before flowering.
- After completion of the field trial the release site and a surrounding area of 15 m have to be inspected for remaining roots for two years and developing basal shoots. Plant material that remains on the release site after the harvest has to be removed and destroyed by chopping or chemical treatment. If transgenic aspen volunteers emerge in the last year of inspection, the inspection period is to be extended for another year.
- No plant species must be cultivated on the release site that impairs the detection of transgenic aspen 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-110909-1 Living Modified Organism Hybrid Aspen, female, modified for an altered morphology and reduced growth
    Federal Research Centre for Forestry and Forest Products(BFH) | Changes in physiology and/or production (Growth rate), Changes in quality and/or metabolite content (Pigmentation / Coloration), Resistance to antibiotics (Kanamycin)
  • BCH-LMO-SCBD-110912-1 Living Modified Organism Hybrid Aspen, female, modified for an altered morphology
    Federal Research Centre for Forestry and Forest Products(BFH) | Changes in quality and/or metabolite content (Pigmentation / Coloration), Resistance to antibiotics (Kanamycin)
  • BCH-LMO-SCBD-110910-1 Living Modified Organism Aspen, female, modified for modified for an altered morphology and reduced growth
    Federal Research Centre for Forestry and Forest Products(BFH) | Changes in physiology and/or production (Growth rate), Changes in quality and/or metabolite content (Pigmentation / Coloration), Resistance to antibiotics (Kanamycin)
  • BCH-LMO-SCBD-110911-1 Living Modified Organism Aspen, male, modified for modified for an altered morphology and reduced growth.
    Federal Research Centre for Forestry and Forest Products(BFH) | Changes in physiology and/or production (Growth rate), Changes in quality and/or metabolite content (Pigmentation / Coloration), Resistance to antibiotics (Kanamycin)
  • BCH-RA-DE-110965-3 Risk Assessment generated by a regulatory process 6786-01-0048 (adv. 42010.0048); Summary of the risk assessment of a deliberate release (field trial) of genetically modified Aspen (Populus tremula L. and P. tremula L. x P. tremuloides Michx.), different independent lines, issued by the German Competent Authority
    Hybrid Aspen, female, modified for an altered morphology and reduced growth | Hybrid aspen, Resistance to antibiotics, Changes in physiology and/or production, Changes in quality and/or metabolite content | Hybrid Aspen, female, modified for an altered morphology | Hybrid aspen, Resistance to antibiotics, Changes in quality and/or metabolite content | Aspen, female, modified for modified for an altered morphology and reduced growth | European aspen, Aspen, Common aspen, Eurasian aspen, quaking aspen, POPTN, Resistance to antibiotics, Changes in physiology and/or production, Changes in quality and/or metabolite content | Aspen, male, modified for modified for an altered morphology and reduced growth. | European aspen, Aspen, Common aspen, Eurasian aspen, quaking aspen, POPTN, Resistance to antibiotics, Changes in physiology and/or production, Changes in quality and/or metabolite content
Document on the decision, communication, notification or declaration
Additional Information
-  type of decision: field trial
-  LMO: differnt independent lines expressing the rolC gene from Agrobacterium rhizogenes
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 28 May 1996 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: 1500 m²/site/year
-  max. 480 LMO/site

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/96/48

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.
EN