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Country's Decision or any other Communication
Record information and status
Record ID
102766
Status
Published
Date of creation
2011-10-27 08:58 UTC (german_bch@bvl.bund.de)
Date of last update
2017-05-23 12:39 UTC (german_bch@bvl.bund.de)
Date of publication
2017-07-13 15:40 UTC (ursula.monnerjahn@bmel.bund.de)

This document is also available in the following languages:
General information
Country submitting the decision or communication
  • Germany
Competent National Authority(ies) responsible for the decision or communication
Federal Office of Consumer Protection and Food Safety
Mauerstrasse 39-42
Berlin
Germany, 10117
Phone:+49-(0)3018-445-6500
Fax:+49-(0)3018-445-6099
Email:german_bch@bvl.bund.de
Url:http://www.biosafety-bch.de (english language),BVL Homepage (English)
Title / Reference number of the decision or communication
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
Date of the decision
2009-07-27
Is the decision taken prior to entry into force of the Protocol?
No
Jurisdiction
  • Germany
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
  • Decision on LMOs for intentional introduction into the environment (according Article 10 or domestic regulatory framework)
Was the decision triggered by a request for a transboundary movement of LMOs into the country?
No
Does the decision apply to transboundary movements of LMO(s) into the country?
No
Importer’s or Applicant’s contact details
Universität Rostock
Agrobiotechnology - Faculty of Agricultural and Environmental Sciences
Justus-von-Liebig-Weg 6

Rostock, Mecklenburg-Vorpommern
Germany, 18059
Phone:+49 381 498 ext 3080
Fax:+49 381 498 ext 3082
Email:dekan.auf@uni-rostock.de
Url:Rostock University,Agrobiotechnology - Rostock University
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
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.
Reasons
To comply with requirements of directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of LMO spread/establishment.
Does the decision involve field trials?
Yes
Does the decision involve commercial release?
No
LMO identification
Petunia modified for antibiotic resistance
Universität Rostock Resistance to antibiotics - Streptomycin Selectable marker genes and reporter genes
Show detection method(s)
Risk assessment
6786-01-0203; 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
Universität Rostock

Resistance to antibiotics - Streptomycin
Selectable marker genes and reporter genes
Additional Information
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