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Country's Decision or any other Communication
Record information and status
Record ID
101531
Status
Published
Date of creation
2011-01-20 14:13 UTC (german_bch@bvl.bund.de)
Date of last update
2017-05-22 14:37 UTC (german_bch@bvl.bund.de)
Date of publication
2017-07-13 15:38 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
6786-01-0171 (adv. 42010-0171); Decision regarding the delliberate release (field trial) of genetically modified oilseed rape (Brassica napus) transformed with plasmids pPSty5, pLH-BnSGT-GUS and pLH7000-SGT/SCT or combinatons thereof, issued by the German Competent Authority.
Date of the decision
2006-05-10
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
FINAB e. V.
Vereins zur Förderung Innovativer und Nachhaltiger AgroBiotechnologie Mecklenburg-Vorpommern e. V. (FINAB e. V.)
Thünenplatz 1
Groß Lüsewitz, Mecklenburg-Vorpommern
Germany, 18190
Phone:+49 (0)381 498 30-81
Email:webmaster@finab.de
Url:FINAB e. V.
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
some confinement measures:
• fertile plant material must be carried in closed and clearly marked repositories; during transport any loss and spillage shall be avoided
• genetically modified oilseed rape seeds may be stored outside a laboratory only if stored in a closed and marked container. Inspection and control authorities must be informed about the storage site.
• during the field trial, control of release site and surrounding area at least once a week, irregularities shall be documented
• pollen compatible plants with a overlapping flowering period compared to the genetically modified oilseed rape plants must be eliminated within an distance of 50 m before seed maturity
• no cultivation of Cruciferae on this site for at least 5 years. In case of more than 5 gm-plants per 150 qm cultivated area in the last year of monitoring, the oilseed cultivation is interrupted for another year.
note: not for food or feed purposes
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
Brassica napus modified for the synthesis of resveratrol
FINAB e. V. Changes in quality and/or metabolite content - Antioxidants, Flavonoids (e.g. anthocyanin) Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Fungi Tolerance to abiotic stress
Brassica napus modified for reduced sinapine content (pLH-BnSGT-GUS)
FINAB e. V. Changes in quality and/or metabolite content - Protein and amino acids Resistance to herbicides - Glufosinate
Brassica napus modified for the synthesis of resveratrol and reduced sinapine content
FINAB e. V. Changes in quality and/or metabolite content - Antioxidants, Flavonoids (e.g. anthocyanin), Protein and amino acids Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Fungi Resistance to herbicides - Glufosinate Tolerance to abiotic stress
Brassica napus modified for reduced sinapine content (pLH7000-SGT/SCT)
FINAB e. V. Changes in quality and/or metabolite content - Protein and amino acids Resistance to herbicides - Glufosinate Selectable marker genes and reporter genes
Risk assessment
6786-01-0171; Summary of the risk assessment of a deliberate release (field trial) of 4 lines of genetically modified oilseed rape (Brassica napus) transformed with plasmids pPSty5, pLH-BnSGT-GUS and pLH7000-SGT/SCT or combinatons issued by the German Competent Authority.
Brassica napus modified for the synthesis of resveratrol
FINAB e. V.

Changes in quality and/or metabolite content - Antioxidants, Flavonoids (e.g. anthocyanin)
Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Fungi
Tolerance to abiotic stress
Brassica napus modified for reduced sinapine content (pLH-BnSGT-GUS)
FINAB e. V.

Changes in quality and/or metabolite content - Protein and amino acids
Resistance to herbicides - Glufosinate
Brassica napus modified for the synthesis of resveratrol and reduced sinapine content
FINAB e. V.

Changes in quality and/or metabolite content - Antioxidants, Flavonoids (e.g. anthocyanin), Protein and amino acids
Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Fungi
Resistance to herbicides - Glufosinate
Tolerance to abiotic stress
Brassica napus modified for reduced sinapine content (pLH7000-SGT/SCT)
FINAB e. V.

Changes in quality and/or metabolite content - Protein and amino acids
Resistance to herbicides - Glufosinate
Selectable marker genes and reporter genes
Additional Information
Additional Information
type of decision: field trial
LMO: Brassica napus, different independent lines transformed with plasmids pPSty5 (line 1104.3.6), pLH-BnSGT-GUS (1501.24) and pLH7000-SGT/SCT (1505.1d) or combinatons thereof (1502.15.7)
legal basis: Directive 2001/18/EC, Gentechnikgesetz [German Gene Technology Act]
scope: test of field performance of LMO
authorization valid from 10 March  2006 to 31 December 2007
location: 1 experimental field located in Germany; for details see German LMO/GMO location register ( https://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showmeldungen.do?flaecheId=392)
size: 480m²/year
app. 48.000 LMO/site

There is a Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/05/171

   
   
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