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Country's Decision or any other Communication (DEC)
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BCH-DEC-DE-102766-4   |   PDF   |   Print   |  
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published: 27 Oct 2011 last updated: 03 Jan 2024
Amendment
No
General Information
6786-01-0203 (adv. 42010.0203); Decision regarding the deliberate release (field trial) of genetically modified petunia (Petunia hybrida) T16, issued by the German Competent Authority
EN
27 Jul 2009
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.
- Fertile plant material has to be stored in closed and clearly labelled repositories for transport and storage at any time outside the release site and laboratory.
- Inspection of release site on unexpected biological traits of the LMO and on reciprocal effects between LMO and other organisms has to be accomplished weekly during the experimental release and monthly after the experimental release.
- Monthly inspection of the surrounding area (10 m) of the release site for transgenic petunia volunteers and their removal and disposal.
- After completion of the field trial, monthly inspection of the release site and surrounding area (10 m) for transgenic petunia volunteers, their documentation and removal and disposal has to be accomplished for one year or longer if volunteers were observed. No plant species must be cultivated on the release site that impairs the detection of transgenic petunia volunteers.
- After completion of the field trial an appropriate land management via harrowing and grubbing is intended to support fast germination of seeds so that transgenic petunia volunteers can be easily destroyed by application of an herbicide.
- 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.
EN
To comply with requirements of directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of LMO spread/establishment.
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-102617-7 Living Modified Organism Petunia modified for antibiotic resistance
    University of Rostock | Resistance to antibiotics (Streptomycin), Selectable marker genes and reporter genes
  • BCH-RA-DE-102765-4 Risk Assessment generated by a regulatory process 6786-01-0203 (bzw. 42010.0203); Summary of the risk assessment of a deliberate release (field trial) of genetically modified petunia (Petunia hybrida) T16, issued by the German Competent Authority
    Petunia modified for antibiotic resistance | Petunia, PETHY, Resistance to antibiotics, Selectable marker genes and reporter genes
Document on the decision, communication, notification or declaration
Additional Information
type of decision: field trial
LMO: petunia (Petunia hybrida) T16
legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
scope: test for out-crossing of genetically modified material  from transplastomic petunias to wildtype petunias
authorization valid from 27th July 2009 to 31st December 2012
locations: one experimental field located 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: 477 m²/Klein Lüsewitz/2009 (13 plants/m²); 208 m²/Klein Lüsewitz/2010 (13 plants/m²)

- There is a Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/08/203
EN