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Country's Decision or any other Communication
Record information and status
Record ID
108332
Status
Published
Date of creation
2015-07-23 12:54 UTC (german_bch@bvl.bund.de)
Date of last update
2017-04-12 13:33 UTC (german_bch@bvl.bund.de)
Date of publication
2017-05-16 10:14 UTC (222@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
6786-01-0141 (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
Date of the decision
2003-12-01
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
GSF - Forschungszentrum für Umwelt und Gesundheit GmbH
GSF - Forschungszentrum für Umwelt und Gesundheit GmbH
Ingolstädter Landstrasse 1
Neuherberg
Germany, 85674
Phone:+49 89 3187-0
Fax:+49 89 3187-3322
Email:info@helmholtz-muenchen.de
Url:Helmholtz Zentrum München - German Research Center for Environmental Health (formerly GSF - Research Center for Environmental Health GmbH)
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
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.
Reasons
To comply with requirements of Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
Does the decision involve field trials?
Yes
Does the decision involve commercial release?
No
LMO identification
MON-Ø4Ø32-6 - Roundup Ready™ soybean
Resistance to herbicides - Glyphosate
Show detection method(s)
Risk assessment
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
Resistance to herbicides - Glyphosate
Additional Information