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Country's Decision or any other Communication (DEC)
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BCH-DEC-DE-109237-5   |   PDF   |   Print   |  
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published: 21 Oct 2015 last updated: 03 Jan 2024
Amendment
No
General Information
6786-01-0210 (adv. 42010.0210); Decision regarding the deliberate release (field trial) of genetically modified tobacco (Nicotiana tabacum) Nt-pDK53, issued by the German Competent Authority
EN
25 May 2012
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
Some confinement measures:
- If any new information on the cultivated LMO emerges that might bear any risk for human health, animal health or the environment the national federal authority needs to be informed and sufficient risk measures have to be performed.
- 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. During transport any loss and spillage of seeds shall be avoided.
- Transgenic and non transgenic tobacco plants have to be stored separately.
- Inspection of release site on unexpected biological traits of the LMO and reciprocal effects between LMO and other organisms has to be accomplished weekly during the experimental release and monthly after the experimental release and sufficient risk measures have to be performed.
- All machines in contact with LMO that have been used on the release site have to be thoroughly cleaned on the release site in order to minimize the possibility of unintended loss and spillage of seeds. LMO plant material from cleaned machines and not used LMO material has to be destroyed by heat inactivation on the release site.
- Crossing compatible tobacco plants, which flower within a distance of 100 m to the release sites should be treated as genetically modified tobacco plants.
- After completion of the field trial monthly inspection of release site and surrounding areas (5 m) for transgenic tobacco volunteers, their documentation and removal and disposal has to be accomplished for one year. The inspection period has to be extended for another year if potato volunteers were observed. No plant species must be cultivated on the release site that impairs the detection of transgenic tobacco volunteers.
- A sign indicating "Versuch mit gentechnisch veränderten Tabakpflanzen, die nicht als Lebensmittel oder Futtermittel zugelassen sind. Eine Entnahme durch Unbefugte ist nicht gestattet." (test with genetically modified potatoes, not authorized for use as food and feed, unauthorized removal is not permitted) has to be put up at the release site.

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-109069-2 Living Modified Organism Tobacco modified for antibiotic resistance and GFP expression
    University of Rostock | Resistance to antibiotics (Streptomycin), Selectable marker genes and reporter genes
  • BCH-RA-DE-109236-3 Risk Assessment generated by a regulatory process 6786-01-0210 (adv. 42010.0210); Summary of the risk assessment of a deliberate release (field trial) genetically modified tobacco (Nicotiana tabacum) Nt-pDK53, issued by the German Competent Authority
    Tobacco modified for antibiotic resistance and GFP expression | Tobacco, TOBAC , Resistance to antibiotics, Selectable marker genes and reporter genes
Document on the decision, communication, notification or declaration