Germany | BCH-DEC-DE-112109 | Country's Decision or any other Communication | Biosafety Clearing-House

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BCH-DEC-DE-112109-2   |   PDF   |   Print   |  

Country's Decision or any other Communication (DEC)

published: 18 Apr 2017 last updated: 23 Nov 2020
Amendment
No
General Information
6786-01-0090 (adv. 42010.0090); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified oilseed rape (Brassica napus L. ssp. oleifera) Ms8, Rf3 and Ms8 x Rf3, issued by the German Competent Authority
EN
22 Jul 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. The label needs to distinctively describe the LMO. Especially during transport, the dispersal of seeds of the transgenic oilseed rape has to be prevented.
Tools used for sowing, harvesting and inactivation have to be cleaned after use in order to minimize the unintended dispersal of genetically modified seeds.
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-14755-7 Living Modified Organism ACS-BNØØ3-6 - InVigor™ canola
    Bayer CropScience | Changes in physiology and/or production (Fertility restoration), Resistance to herbicides (Glufosinate)
  • BCH-LMO-SCBD-14759-8 Living Modified Organism ACS-BNØØ5-8 - InVigor™ canola
    Bayer CropScience | Changes in physiology and/or production (Reproduction, Male sterility), Resistance to antibiotics (Kanamycin), Resistance to herbicides (Glufosinate)
  • BCH-LMO-SCBD-14760-9 Living Modified Organism ACS-BNØØ5-8 × ACS-BNØØ3-6 - InVigor™ canola
    Bayer CropScience | Changes in physiology and/or production (Reproduction, Male sterility), Resistance to herbicides (Glufosinate)
  • BCH-RA-DE-112108-2 Risk Assessment generated by a regulatory process 6786-01-0090 (adv. 42010.0090); Summary of the risk assessment of a deliberate release (field trial) of genetically modified oilseed rape (Brassica napus L. ssp. oleifera) Ms8, Rf3 and Ms8 x Rf3, issued by the German Competent Authority
    ACS-BNØØ3-6 - InVigor™ canola | Turnip, Rapeseed, Canola Plant, Oilseed Rape, Rape, BRANA, Resistance to herbicides, Changes in physiology and/or production | ACS-BNØØ5-8 - InVigor™ canola | Turnip, Rapeseed, Canola Plant, Oilseed Rape, Rape, BRANA, Resistance to herbicides, Resistance to antibiotics, Changes in physiology and/or production | ACS-BNØØ5-8 x ACS-BNØØ3-6 - InVigor™ canola | Canola plant, Resistance to herbicides, Changes in physiology and/or production
Document on the decision, communication, notification or declaration
Additional Information
-  type of decision: field trial
-  LMO: Ms8, Rf3 and Ms8 x Rf3
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 22 July 1999 to 31 December 2007
-  locations: 8 experimental fields located in 8 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?)
-  total size: 95.920 m²/year;
-  max. 11.510.400 LMO in total

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/98/90

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