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Country's Decision or any other Communication (DEC)
  |  
BCH-DEC-DE-110834-5   |   PDF   |   Print   |  
published: 22 Aug 2016 last updated: 15 Dec 2023
Amendment
No
General Information
6786-01-0061 (adv. 42010.0061); Decision regarding the risk assessment of a deliberate release (field trial) of the genetically modified oilseed rape plants (Brassica napus L.), offspring of the F1 hybrid 23-198, issued by the German Competent Authority
EN
25 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.
-  The release site has to be surrounded by shelter-crops (6 m) and a 50 m isolation area, or a 100 m isolation area without 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
-  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-14782-5 Living Modified Organism CGN-89465-2 - High oleic acid canola
    Monsanto (Calgene) | Production of medical or pharmaceutical compounds (human or animal) (Omega-3 fatty acids (e.g. DHA)), Resistance to antibiotics (Kanamycin)
  • BCH-RA-DE-110832-3 Risk Assessment generated by a regulatory process 6786-01-0061 (adv. 42010.0061); Summary of the risk assessment of a deliberate release (field trial) of the genetically modified oilseed rape (Brassica napus L.), offspring of the F1 hybrid 23-198 (Event 23), issued by the German Competent Authority
    CGN-89465-2 - High oleic acid canola | Turnip, Rapeseed, Canola Plant, Oilseed Rape, Rape, BRANA, Resistance to antibiotics, Production of medical or pharmaceutical compounds (human or animal)
Document on the decision, communication, notification or declaration
Additional Information
The LMO released here is the offspring of a F1 hybrid of 23-198 (Event 23, UID: CGN-89465-2; see BCH record 14782). While the original transformant (Event 23) was estimated to have 15 copies of the T-DNA integrated at 5 independent loci in the genome, the F1 hybrid only has integrated 4 to 6 copies.

-  type of decision: field trial
-  LMO: progeny of the F1 hybrid 23-198
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 25 March 1997 to 31 December 2002
-  locations: 10 experimental fields located in 9 villages in Germany; for details see German LMO/GMO location register ( http://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
-  size: 34000 m²/site/year
-  max. 1 million LMO/site/year

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/97/61
EN