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Country's Decision or any other Communication
Record information and status
Record ID
110968
Status
Published
Date of creation
2016-09-12 10:42 UTC (german_bch@bvl.bund.de)
Date of last update
2020-10-28 15:31 UTC (german_bch@bvl.bund.de)
Date of publication
2020-10-29 13:00 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
6786-01-0083 (adv. 42010.0083); Decision regarding the risk assessment of a deliberate release (field trial) of the genetically modified oilseed rape plants (Brassica napus L.), different independent lines with an altered storage lipid composition, issued by the German Competent Authority
Date of the decision
1998-04-29
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
DSV
Deutsche Saatveredelung AG (DSV)
Weissenburger Straße 5
59557 Lippstadt
Lippstadt
Germany, 59557
Phone:+49 2941 2960
Fax:+49 2941 296100
Email:info@dsv-saaten.de
Url:https://www.dsv-saaten.de/
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 and has to keep separately from non-transgenic plant material.
-  Machines that have been in contact with LMOs have to be cleaned after use
-  All remaining fertile plant material has to be destroyed by disruption of the germination capacity.
- The release site has to be surrounded by shelter-crops (3 m) with an isolation band of 50 m. Alternatively, the site has to be surrounded by an isolation band of 100 m if no shelter crops are used.
-  After harvest and in the following 2 years, no oilseed rape must be grown in the field site. The release site and surrounding area (5 m) have to be inspected regularly for oilseed rape volunteers. Emerging volunteers have to removed before flowering and destroyed by disruption of their germination capacity (incineration, chopping, squeezing).
-  No plant species must be cultivated on the release site that impairs the detection of transgenic oilseed rape volunteers.
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
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV Changes in quality and/or metabolite content - Lipid and fatty acids Resistance to antibiotics - Kanamycin
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV Changes in quality and/or metabolite content - Lipid and fatty acids Resistance to antibiotics - Kanamycin
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV Changes in quality and/or metabolite content - Lipid and fatty acids Resistance to antibiotics - Kanamycin
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV Changes in quality and/or metabolite content - Lipid and fatty acids Resistance to antibiotics - Kanamycin
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV Changes in quality and/or metabolite content - Lipid and fatty acids Resistance to antibiotics - Kanamycin
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV Changes in quality and/or metabolite content - Lipid and fatty acids Resistance to antibiotics - Kanamycin
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV Changes in quality and/or metabolite content - Lipid and fatty acids Resistance to antibiotics - Kanamycin
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV Changes in quality and/or metabolite content - Lipid and fatty acids Resistance to antibiotics - Kanamycin
Risk assessment
6786-01-0083 (adv. 42010.0083); Summary of the risk assessment of a deliberate release (field trial) of genetically modified oilseed rape (Brassica napus L.), different independent lines with an altered storage lipid composition, issued by the German Competent Authority
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV

Changes in quality and/or metabolite content - Lipid and fatty acids
Resistance to antibiotics - Kanamycin
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV

Changes in quality and/or metabolite content - Lipid and fatty acids
Resistance to antibiotics - Kanamycin
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV

Changes in quality and/or metabolite content - Lipid and fatty acids
Resistance to antibiotics - Kanamycin
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV

Changes in quality and/or metabolite content - Lipid and fatty acids
Resistance to antibiotics - Kanamycin
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV

Changes in quality and/or metabolite content - Lipid and fatty acids
Resistance to antibiotics - Kanamycin
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV

Changes in quality and/or metabolite content - Lipid and fatty acids
Resistance to antibiotics - Kanamycin
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV

Changes in quality and/or metabolite content - Lipid and fatty acids
Resistance to antibiotics - Kanamycin
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV

Changes in quality and/or metabolite content - Lipid and fatty acids
Resistance to antibiotics - Kanamycin
Additional Information
Additional Information
-  type of decision: field trial
-  LMO: differnt independent lines with various modified genes which are involved in the lipid acid metabolism
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 29 April 1998 to 31 December 2001
-  locations: 1 experimental field located in 1 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?)

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/97/83

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.