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Country's Decision or any other Communication
Record information and status
Record ID
103567
Status
Published
Date of creation
2012-06-01 11:01 UTC (german_bch@bvl.bund.de)
Date of last update
2017-05-31 12:50 UTC (german_bch@bvl.bund.de)
Date of publication
2017-07-13 15:45 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
6786-01-0169; Decision regarding the deliberate release (field trial) of genetically modified maize (Zea mays) hybrid lines MON810, MON88017 and MON88017 x MON810 issued by the German Competent Authority
Date of the decision
2005-10-28
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
Monsanto Agrar Deutschland GmbH
Monsanto Agrar Deutschland GmbH
Vogelsanger Weg 91
Düsseldorf
Germany, 40470
Phone:+ 49 (0) 211 - 36 75-0
Fax:+ 49 (0) 2 11 - 36 75-333
Email:mon@monsanto.de
Url:Monsanto Agrar Deutschland GmbH
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
- Fertile plant material has to be transported and stored in closed and clearly labelled repositories at any time outside the release site and biogas plants. Flowering plants and plant material including blossoms have to be transported in containers that prevent the distribution of pollen from the plant material. Genetically modified maize and wild type maize has to be stored separately at any time.
- Repositories and containers for transport, seed drills, crop chopper and machines used for inactivation of the germination capacity of corn need to be thoroughly cleaned after usage to prevent accidental transfer of genetically modified seeds.
- The release site of the genetically modified maize has to be in the distance of at least 200 m to other maize cultivation areas or maize that is cultivated closer to the genetically modified maize has not to be used as food and feed and needs to be destroyed for instance within a biogas plant.
- After completion of the field trial, maize must not be cultivated on the release site for one year. During this period, the release site, the area where shelter crops were planted and further 10 m of surrounding area have to be inspected for transgenic maize volunteers. Volunteers have to be removed and disposed prior to inflorescence.
- Maize plants that are not transported to genetic engineering facilities have to be destroyed by destroying the germination capacity of corn kernels, inactivating plant material of the genetically modified maize and shelter crops through appropriate land management (chaffing of plant material and subsequent covering with soil) or by disposal in biogas plants (efficient inactivation needs to be assured) or by composting of all non-fertile plant material (leaves, petioles, cobs, bracts, silage maize) on the release site; this is also permitted for corn kernels that were inactivated through mechanical procedures.
- 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 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
MON-ØØ81Ø-6 - YieldGard™ maize
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths)
Show detection method(s)
MON-88Ø17-3 - YieldGard™ VT™ Rootworm/RR2™ Maize
Resistance to diseases and pests - Insects - Coleoptera (beetles) Resistance to herbicides - Glyphosate
Show detection method(s)
MON-88Ø17-3 x MON-ØØ81Ø-6 - YieldGard™ VT Triple
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths) Resistance to herbicides - Glyphosate
Show detection method(s)
Risk assessment
6786-01-0169; Summary of the risk assessment of a deliberate release (field trial) of genetically modified maize (Zea mays) hybrid lines MON810, MON88017 and MON88017 x MON810 issued by the German Competent Authority
MON-ØØ81Ø-6 - YieldGard™ maize
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths)
MON-88Ø17-3 - YieldGard™ VT™ Rootworm/RR2™ Maize
Resistance to diseases and pests - Insects - Coleoptera (beetles)
Resistance to herbicides - Glyphosate
MON-88Ø17-3 x MON-ØØ81Ø-6 - YieldGard™ VT Triple
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glyphosate
Additional Information
Additional Information
- type of decision: field trial
- LMO: hybride lines of MON810, MON88017 and MON88017 x MON810,
- legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
- scope: test of field performance of LMO
- authorization valid within the vegetation periods of the years 2006 to 2010
- locations: 5 experimental fields located in 5 different villages 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: release site 1: 5 ha, release site 2: 20 ha, release site 3: 29 ha, release site 4: 3.1 ha, release site 5: 9.2 ha
max. 100,000 LMO/site
- related publications:
De Schrijver A, Devos Y, Van den Bulcke M, Cadot P, De Loose M, Reheul D, Sneyers M (2007) Risk assessment of GM stacked events obtained from crosses between GM events, Trends in Food Science & Technology, 18, 2, 101-109
Taylor ML, Hartnell G, Nemeth M, Karunanandaa K, George B (2005) Comparison of Broiler Performance When Fed Diets Containing Corn Grain with Insect-Protected (Corn Rootworm and European Corn Borer) and Herbicide-Tolerant (Glyphosate) Traits, Control Corn, or Commercial Reference Corn-Revisited, Poultry Science, 84, 1893-1899