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Country's Decision or any other Communication (DEC)
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BCH-DEC-DE-110970-3   |   PDF   |   Print   |  
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published: 13 Sep 2016 last updated: 28 Oct 2020
Amendment
No
General Information
6786-01-0057 (adv. 42010-0057); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified oilseed rape plants (Brassica napus L.), different independent lines with an altered storage lipid composition, issued by the German Competent Authority
EN
27 Mar 1997
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 be kept separately from non-transgenic plant material.
-  All remaining fertile plant material has to be destroyed by disruption of their germination capacity.
-  Machines that have been in contact with LMOs have to be cleaned after use.
-  The release site has to be surrounded by shelter-crops.
-  Plant material that remains on the release site after the harvest has to be removed and destroyed by chopping or chemical treatment.
-  After completion of the field trial the release site and a surrounding area of 10 m have to be inspected for transgenic oilseed rape volunteers.
-  The inspection period has to be extended for another year if transgenic oilseed rape volunteers were observed in the last year of the inspection period.
-  No plant species must be cultivated on the release site that impairs the detection of transgenic oilseed rape 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-101385-4 Living Modified Organism Brassica napus modified for altered fatty acid metabolism
    Bundesanstalt für Züchtungsforschung an Kulturpflanzen(BAZ) | Changes in quality and/or metabolite content (Lipid and fatty acids), Resistance to antibiotics (Kanamycin)
  • BCH-LMO-SCBD-110919-1 Living Modified Organism Oilseed rape modified for an altered fatty acid metabolism in the seeds
    Deutsche Saatveredelung AG(DSV) | Changes in quality and/or metabolite content (Lipid and fatty acids), Resistance to antibiotics (Kanamycin)
  • BCH-LMO-SCBD-110940-2 Living Modified Organism Oilseed rape modified for increased myristic acid content in the seeds
    Deutsche Saatveredelung AG(DSV) | Changes in quality and/or metabolite content (Lipid and fatty acids), Resistance to antibiotics (Kanamycin)
  • BCH-LMO-SCBD-110922-1 Living Modified Organism Oilseed rape modified for increased oleic acid content in the seeds
    Deutsche Saatveredelung AG(DSV) | Changes in quality and/or metabolite content (Lipid and fatty acids), Resistance to antibiotics (Kanamycin)
  • BCH-RA-DE-110969-3 Risk Assessment generated by a regulatory process 6786-01-0057 (adv. 42010.0057); Summary of the risk assessment of a deliberate release (field trial) of genetically modified oilseed rape (Brassica napus L.), different independend lines with an altered storage lipid composition, issued by the German Competent Authority
    Brassica napus modified for altered fatty acid metabolism | Turnip, Rapeseed, Canola Plant, Oilseed Rape, Rape, BRANA, Resistance to antibiotics, Changes in quality and/or metabolite content | Oilseed rape modified for an altered fatty acid metabolism in the seeds | Turnip, Rapeseed, Canola Plant, Oilseed Rape, Rape, BRANA, Resistance to antibiotics, Changes in quality and/or metabolite content | Oilseed rape modified for increased myristic acid content in the seeds | Resistance to antibiotics, Changes in quality and/or metabolite content | Oilseed rape modified for increased oleic acid content in the seeds | Turnip, Rapeseed, Canola Plant, Oilseed Rape, Rape, BRANA, 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: different independent lines transformed with pNBM99-ClFatB4, pNBM99-EnClFatB4, pRE1-E12, pRESS and/or pNAT4
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 27 March 1997 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?)

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/97/57

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