Germany | BCH-DEC-DE-108332 | 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-108332-4   |   PDF   |   Print   |  
published: 23 Jul 2015 last updated: 03 Jan 2024
Amendment
No
General Information
6786-01-0141 (adv. 42010.0141); Decision regarding the deliberate release (field trial) of genetically modified soybeans (Glycine max L. Merrill) GTS 40-3-2, issued by the German Competent Authority
EN
01 Dec 2003
No
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
- The specification of the exact release site.
- Closed and clearly labelled repositories have to be used to transport any fertile plant material to and from the release site. The label needs to distinctively describe the LMO.
- In the case of transport of seeds or seed-bearing plant material from the release site measures have to be taken to avoid spreading of seeds.
- Machines - where required also those used for inactivation of corn seeds - and transportation containers that have been in contact with LMOs have to be cleaned thoroughly after use to minimize unintended transfer of genetically modified seeds.
- If plant material will be stored outside a genetic engineering facility the national federal authority needs to be informed about location and expected period a priori. Closed and clearly labelled containers have to be used for storage of seeds.
- All genetically modified soybean seeds that are not needed as seeds or for further experimental analysis have to be inactivated by appropriate measures.
- After completion of the field trial the release site and its surrounding area has to be controlled for one year. During this time in the vegetation period a regular inspection of this area has to be conducted for transgenic soybean volunteers. Soybean volunteers have to be removed and destroyed before flowering. The inspection period has to be extended for another year if soybean volunteers were observed.
- Also for the period of post-control recognition of the release site has to be ensured by sufficient measures.
EN
To comply with requirements of Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-14796-14 Living Modified Organism MON-Ø4Ø32-6 - Roundup Ready™ soybean
    Monsanto | Resistance to herbicides (Glyphosate)
  • BCH-RA-DE-108331-3 Risk Assessment generated by a regulatory process 6786-01-0141 (adv. 42010.0141); Summary of the risk assessment of a deliberate release (field trial) of genetically modified soybeans (Glycine max L. Merrill) GTS 40-3-2, issued by the German Competent Authority
    MON-Ø4Ø32-6 - Roundup Ready™ soybean | Soybean, Soya bean, Soya, SOYBN, Resistance to herbicides
Document on the decision, communication, notification or declaration
Additional Information
- type of decision: field trial
- LMO: GTS 40-3-2
- legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
- scope: test of field performance of LMO (in lysimeter)
- authorization valid from 01/12/2003 to 31/12/2009
- locations: 1 experimental field located in 1 village 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: 4 x 1 m²/site/year
- max. 35 LMO/m²
EN