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Country's Decision or any other Communication
Record information and status
Record ID
112109
Status
Published
Date of creation
2017-04-18 09:57 UTC (german_bch@bvl.bund.de)
Date of last update
2020-11-23 12:40 UTC (german_bch@bvl.bund.de)
Date of publication
2020-11-24 12:28 UTC (nina.opitz@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
6786-01-0090 (adv. 42010.0090); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified oilseed rape (Brassica napus L. ssp. oleifera) Ms8, Rf3 and Ms8 x Rf3, issued by the German Competent Authority
Date of the decision
1998-07-22
Is the decision taken prior to entry into force of the Protocol?
Yes
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
Bayer CropScience
Bayer CropScience Deutschland GmbH
Bayer CropScience AG
Alfred-Nobel-Str. 50
40789 Monheim am Rhein
Monheim am Rhein
Germany, 40789
Phone:+49 21 73 - 38-0
Url:Bayer CropScience
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 laboratory. The label needs to distinctively describe the LMO. Especially during transport, the dispersal of seeds of the transgenic oilseed rape has to be prevented.
Tools used for sowing, harvesting and inactivation have to be cleaned after use in order to minimize the unintended dispersal of genetically modified seeds.
Reasons
To comply with requirements of Directive 90/220/EEC, 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
ACS-BNØØ3-6 - InVigor™ canola
Changes in physiology and/or production - Fertility restoration Resistance to herbicides - Glufosinate
Show detection method(s)
ACS-BNØØ5-8 - InVigor™ canola
Changes in physiology and/or production - Reproduction - Male sterility Resistance to herbicides - Glufosinate
Show detection method(s)
ACS-BNØØ5-8 x ACS-BNØØ3-6 - InVigor™ canola
Changes in physiology and/or production - Reproduction - Male sterility Resistance to herbicides - Glufosinate
Show detection method(s)
Risk assessment
6786-01-0090 (adv. 42010.0090); Summary of the risk assessment of a deliberate release (field trial) of genetically modified oilseed rape (Brassica napus L. ssp. oleifera) Ms8, Rf3 and Ms8 x Rf3, issued by the German Competent Authority
ACS-BNØØ3-6 - InVigor™ canola
Changes in physiology and/or production - Fertility restoration
Resistance to herbicides - Glufosinate
ACS-BNØØ5-8 - InVigor™ canola
Changes in physiology and/or production - Reproduction - Male sterility
Resistance to herbicides - Glufosinate
ACS-BNØØ5-8 x ACS-BNØØ3-6 - InVigor™ canola
Changes in physiology and/or production - Reproduction - Male sterility
Resistance to herbicides - Glufosinate
Additional Information
Additional Information
-  type of decision: field trial
-  LMO: Ms8, Rf3 and Ms8 x Rf3
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 22 July 1999 to 31 December 2007
-  locations: 8 experimental fields located in 8 village in Germany, for details refer to the German LMO/GMO location register ( https://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
-  total size: 95.920 m²/year;
-  max. 11.510.400 LMO in total

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/98/90

The decision on this deliberate release was made by the Robert Koch Institute (RKI).
The RKI was the competent national authority for the German Gene Technology Act before the competences were transferred to the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL) on April 1st 2004. Deliberate releases that were authorized by the RKI prior to this date are now handled by the BVL.