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Country's Decision or any other Communication
Record information and status
Record ID
102933
Status
Published
Date of creation
2011-12-07 10:39 UTC (german_bch@bvl.bund.de)
Date of last update
2017-05-23 13:26 UTC (german_bch@bvl.bund.de)
Date of publication
2017-07-13 15:41 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
6786-01-0178 (adv. 42010.0178); Decision regarding the deliberate release (field trial) of genetically modified wheat (Triticum aestivum) HOSUT,  XAP, SUTAP60, SUTAP69 and SUTAP78 issued by the German Competent Authority
Date of the decision
2006-11-23
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
Institut für Pflanzengenetik und Kulturpflanzenforschung
Corrensstrasse 3 
Gatersleben
Germany, 06466
Phone:+49 (0)39482 5-0
Fax:+49 (0) 39482 5139
Email:info@ipk-gatersleben.de
Url:IPK Gatersleben
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
- The release site has to be surrounded by Phacelia shelter-crops.
- To repel small mammals the field site has to be surrounded by a fine-meshed fence in the time periods from sowing to young plants that have at least one leaf and from dough-ripe stage to harvest.
- Inspection of the release site on unexpected biological traits of the LMO and on disturbance by wildlife has to be accomplished weekly during the experimental release and sufficient risk measures have to be performed.
- 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. On the labels it needs to be noted that this wheat is unfit for consumption.
- Not used LMO material has to be destroyed by autoclaving; straw by burning on the release site.
- After completion of the field trial, the release site and the surrounding shelter-crops have to be shallowly dug under the soil.
- For two years, the release site must not be cultivated with plants impairing the detection of transgenic volunteers. 
- After completion of the field trial an inspection of the release site and the surrounding area for transgenic wheat volunteers, their documentation and removal and disposal has to be accomplished every two weeks for two years or if volunteers were observed for one year longer.
- Machines that have been in contact with LMOs have to be cleaned after use.
- 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 GMO spread/establishment.
Does the decision involve field trials?
Yes
Does the decision involve commercial release?
No
LMO identification
High-protein, herbicide resistant wheat HOSUT
Changes in physiology and/or production - Yield Changes in quality and/or metabolite content - Carbohydrates Resistance to herbicides - Glufosinate
High-protein, antibiotic and herbicide resistant wheat SUTAP60
Changes in quality and/or metabolite content - Protein and amino acids Resistance to antibiotics - Ampicillin Resistance to herbicides - Glufosinate
High-protein, antibiotic and herbicide resistant wheat SUTAP69
Changes in quality and/or metabolite content - Protein and amino acids Resistance to antibiotics - Ampicillin Resistance to herbicides - Glufosinate
High-protein, antibiotic and herbicide resistant wheat SUTAP78
Changes in quality and/or metabolite content - Protein and amino acids Resistance to antibiotics - Ampicillin Resistance to herbicides - Glufosinate
Wheat modified for increased protein content
Changes in quality and/or metabolite content - Protein and amino acids Resistance to antibiotics - Ampicillin Resistance to herbicides - Glufosinate
Risk assessment
6786-01-0178; Summary of the risk assessment of a deliberate release (field trial) of genetically modified wheat (Triticum aestivum) HOSUT, XAP, SUTAP60, SUTAP69 and SUTAP78 issued by the German Competent Authority
High-protein, herbicide resistant wheat HOSUT
Changes in physiology and/or production - Yield
Changes in quality and/or metabolite content - Carbohydrates
Resistance to herbicides - Glufosinate
High-protein, antibiotic and herbicide resistant wheat SUTAP60
Changes in quality and/or metabolite content - Protein and amino acids
Resistance to antibiotics - Ampicillin
Resistance to herbicides - Glufosinate
High-protein, antibiotic and herbicide resistant wheat SUTAP69
Changes in quality and/or metabolite content - Protein and amino acids
Resistance to antibiotics - Ampicillin
Resistance to herbicides - Glufosinate
High-protein, antibiotic and herbicide resistant wheat SUTAP78
Changes in quality and/or metabolite content - Protein and amino acids
Resistance to antibiotics - Ampicillin
Resistance to herbicides - Glufosinate
Wheat modified for increased protein content
Changes in quality and/or metabolite content - Protein and amino acids
Resistance to antibiotics - Ampicillin
Resistance to herbicides - Glufosinate
Additional Information
Additional Information
- type of decision: field trial
- LMO: HOSUT, XAP, SUTAP60, SUTAP 69, SUTAP78
- legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
- scope: test of field performance of LMO
- authorization valid from 23 November 2006 to 31. December 2008
- locations: 1 experimental field located in Germany; for details see German LMO/GMO location register  (http://apps2.bvl.bund.de/stareg_web/showflaechen.do)
- size: Two sites of 150 m² and 1050 m² at one field were cultivated between 2006 and 2008

- There is a Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/06/178