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Country's Decision or any other Communication
Record information and status
Record ID
108642
Status
Published
Date of creation
2015-09-04 11:49 UTC (german_bch@bvl.bund.de)
Date of last update
2017-04-12 13:37 UTC (german_bch@bvl.bund.de)
Date of publication
2017-05-16 11:17 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
6786-01-0208 (adv. 42010.0208); Decision regarding the deliberate release (field trial) of genetically modified maize (Zea mays) 1507, 59122, 98140, 1507x59122, 98140x59122, 98140x1507 and 98140x1507x59122 issued by the German Competent Authority
Date of the decision
2010-04-28
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
Pioneer Hi-Bred Northern Europe Sales Division GmbH
Apensener Str. 198
Buxtehude, Niedersachsen
Germany, 21604
Url:Pioineer Hi-Bred Northern Europe, Deutschland,Pioneer Hi-Bred International
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
- The specification of the exact release site.
- 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.
- 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 and it needs to be noted that this is a genetically modified maize that has not to be used as food or feed. In the case of transport of flowering plants or plant material from the release site to a genetic engineering facility transportation containers have to be used that avoid spreading of pollen. 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.
- Inspection of the release site on unexpected biological traits of the LMO and reciprocal effects between LMO and other organisms has to be accomplished weekly during the vegetation period. If required sufficient risk measures have to be performed.
- During the release period the surrounding area of the release site (10 m) has to be inspected monthly during the vegetation period for transgenic maize volunteers which have to be removed and disposed.
- After completion of the field trial no maize has to be planted on the release site, its surrounding area and further 10 m of marginal strip for one year. During this time in the vegetation period a monthly inspection of this area has to be conducted for transgenic maize volunteers. Maize volunteers have to be removed and destroyed before flowering. Also for the period of post-control recognition of the release site has to be ensured by sufficient measures.
- If genetically modified plants are not transferred to a genetic engineering facility the following measures have to be respected for disposal: All corn seeds that are not needed as seeds or for further experimental analysis or that were found by cleaning the working equipment have to be destroyed by disruption of the germination capacity. Silage maize might be chaffed, grain maize might be milled or dugged under the soil. The plant material might also be transferred to a biogas plant if it is fully inactivated during the process of biogas extraction. Temporary storage as silage is possible in closed and clearly labelled containers outside the release site. The label needs to distinctively describe the LMO and it needs to be noted that this is a genetically modified maize that has not to be used as food or feed. The national federal authority needs to be informed about location and expected period of a storage or about the location and date of transfer of genetically modified plant material to a biogas plant a priori.
- An isolation distance of at least 300 m to fields with non-transgenic maize needs to be respected. Maize cultivated within this isolation distance has not to be used as food or feed and needs to be disrupted (e.g. within a biogas plant). The isolation distance has to be adapted regarding the valid Gentechnik-Pflanzenerzeugungsverordnung (GenTPflEV, Ordinance on Good Practice in the Production of Genetically Modified Plants) if higher distances are demanded.
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
DAS-Ø15Ø7-1 - Herculex™ I maize
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate
Show detection method(s)
DAS-59122-7 - Herculex™ RW Rootworm Protection maize
Resistance to diseases and pests - Insects - Coleoptera (beetles) Resistance to herbicides - Glufosinate
Show detection method(s)
DP-Ø9814Ø-6 - Optimum™ GAT™ maize
Resistance to herbicides - Glyphosate, Sulfonylurea
Show detection method(s)
DAS-Ø15Ø7-1 x DAS-59122-7 - Herculex XTRA™ maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate
Show detection method(s)
DP-Ø9814Ø-6 x DAS-59122-7 - Maize modified for insect resistance and herbicide tolerance
Resistance to diseases and pests - Insects - Coleoptera (beetles) Resistance to herbicides - Glufosinate, Glyphosate, Sulfonylurea
Show detection method(s)
DP-Ø9814Ø-6 x DAS-Ø15Ø7-1 - Maize modified for insect resistance and herbicide tolerance
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate, Sulfonylurea
Show detection method(s)
DP-Ø9814Ø-6 x DAS-Ø15Ø7-1 x DAS-59122-7 - Maize modified for insect resistance and herbicide tolerance
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate, Sulfonylurea
Show detection method(s)
Risk assessment
6786-01-0208 (adv. 42010.0208); Summary of the risk assessment of a deliberate release (field trial) of genetically modified maize (Zea mays) 1507, 59122, 98140, 1507x59122, 98140x59122, 98140x1507 and 98140x1507x59122 issued by the German Competent Authority
DAS-Ø15Ø7-1 - Herculex™ I maize
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate
DAS-59122-7 - Herculex™ RW Rootworm Protection maize
Resistance to diseases and pests - Insects - Coleoptera (beetles)
Resistance to herbicides - Glufosinate
DP-Ø9814Ø-6 - Optimum™ GAT™ maize
Resistance to herbicides - Glyphosate, Sulfonylurea
DAS-Ø15Ø7-1 x DAS-59122-7 - Herculex XTRA™ maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate
DP-Ø9814Ø-6 x DAS-59122-7 - Maize modified for insect resistance and herbicide tolerance
Resistance to diseases and pests - Insects - Coleoptera (beetles)
Resistance to herbicides - Glufosinate, Glyphosate, Sulfonylurea
DP-Ø9814Ø-6 x DAS-Ø15Ø7-1 - Maize modified for insect resistance and herbicide tolerance
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate, Sulfonylurea
DP-Ø9814Ø-6 x DAS-Ø15Ø7-1 x DAS-59122-7 - Maize modified for insect resistance and herbicide tolerance
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate, Sulfonylurea
Additional Information
Additional Information
- type of decision: field trial
LMOs: 1507, 59122, 98140, 1507x59122, 98140x59122, 98140x1507 and 98140x1507x59122
- legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
- scope: test of field performance of LMO
- authorization valid from 28/04/2010 to 31/12/2014
- locations: experimental fields located in 2 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: 50000 - 70000 m²/site/year