Germany | BCH-DEC-DE-110968 | Country's Decision or any other Communication | Biosafety Clearing-House

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Country's Decision or any other Communication (DEC)
  |  
BCH-DEC-DE-110968-3   |   PDF   |   Print   |  
published: 12 Sep 2016 last updated: 28 Oct 2020
Amendment
No
General Information
6786-01-0083 (adv. 42010.0083); Decision regarding the risk assessment of a deliberate release (field trial) of the genetically modified oilseed rape plants (Brassica napus L.), different independent lines with an altered storage lipid composition, issued by the German Competent Authority
EN
29 Apr 1998
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.
-  Machines that have been in contact with LMOs have to be cleaned after use
-  All remaining fertile plant material has to be destroyed by disruption of the germination capacity.
- The release site has to be surrounded by shelter-crops (3 m) with an isolation band of 50 m. Alternatively, the site has to be surrounded by an isolation band of 100 m if no shelter crops are used.
-  After harvest and in the following 2 years, no oilseed rape must be grown in the field site. The release site and surrounding area (5 m) have to be inspected regularly for oilseed rape volunteers. Emerging volunteers have to removed before flowering and destroyed by disruption of their germination capacity (incineration, chopping, squeezing).
-  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-110921-1 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-110914-1 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-110915-1 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-110916-1 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-110917-1 Living Modified Organism Oilseed rape modified for an altered fatty acid metabolism in the seeds
    Deutsche Saatveredelung AG(DSV) | Resistance to antibiotics (Kanamycin)
  • BCH-LMO-SCBD-110918-1 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-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-110920-1 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-RA-DE-110967-3 Risk Assessment generated by a regulatory process 6786-01-0083 (adv. 42010.0083); Summary of the risk assessment of a deliberate release (field trial) of genetically modified oilseed rape (Brassica napus L.), different independent lines with an altered storage lipid composition, issued by the German Competent Authority
    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 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 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 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 an altered fatty acid metabolism in the seeds | Turnip, Rapeseed, Canola Plant, Oilseed Rape, Rape, BRANA, Resistance to antibiotics | 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 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 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
Document on the decision, communication, notification or declaration
Additional Information
-  type of decision: field trial
-  LMO: differnt independent lines with various modified genes which are involved in the lipid acid metabolism
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 29 April 1998 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/97/83

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