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Country's Decision or any other Communication
Record information and status
Record ID
101218
Status
Published
Date of creation
2010-06-03 10:34 UTC (german_bch@bvl.bund.de)
Date of last update
2017-05-22 12:49 UTC (german_bch@bvl.bund.de)
Date of publication
2017-07-13 15:37 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
6786-01-0159 (adv. 42010-0159); Decision regarding the risk assessment of a deliberate release (field trial) of the genetically modified potato plants (Solanum tuberosum L.) transformed with plasmids pBinAR-StSDD1 and pBinARHyg-AtSDD1 issued by the German Competent Authority
Date of the decision
2005-04-01
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
Max Planck Institute of Molecular Plant Physiology (MPIMP)
Max-Planck-Institut für Molekulare Pflanzenphysiologie
Am Mühlenberg 1
Potsdam
Germany, 14476
Phone:+49 331 567 - 80
Fax:+49 331 567 - 84 08
Email:contact@mpimp-golm.mpg.de
Url:Max-Planck-Institut für Molekulare Pflanzenphysiologie
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
some confinement measures:
• field trial takes place on a 12 ha fenced site
• storage of seed potatoes isolated from non-gmo potatoes
• isolation distance to non-gmo potato fields: minimum 20 m
• area 30 m surrounding the field trial must be controlled min. 1/month on occurrence of gentically modified potatoes, these must be destroyed.
• frequent control of the field trial minimum 1/week
• fertile plant material must be carried in closed and clearly marked repositories
• remaining fertile plant material must be destroyed in a way that impedes germination.
• after harvest and in spring of the following year the soil of the release site must be harrowed to 15-20 cm depth, appearing potato tubers must be collected manually and destroyed.
• control of release site and surrounding area for volunteers 1 year after end of experiments, volunteers and tubers have to be destroyed
note: not for food or feed purposes
Reasons
Conditions are set in order to comply with the requirements of Directive 2001/18/EC, Gentechnikgesetz [German Gene Technology Act], i. e. to reduce the possibility of GMO spread into the environment.
Does the decision involve field trials?
Yes
Does the decision involve commercial release?
No
LMO identification
Potato modified for increased Stomata Density
Resistance to antibiotics - Kanamycin Tolerance to abiotic stress - Drought
Potato modified for decreased Stomata Density
Resistance to antibiotics - Hygromycin Tolerance to abiotic stress - Drought
Risk assessment
6786-01-0159; Summary of the risk assessment of a deliberate release (field trial) of genetically modified potatoes transformed with plasmids pBinAR-StSDD1 and pBinARHyg-AtSDD1 issued by the German Competent Authority
Potato modified for increased Stomata Density
Resistance to antibiotics - Kanamycin
Tolerance to abiotic stress - Drought
Potato modified for decreased Stomata Density
Resistance to antibiotics - Hygromycin
Tolerance to abiotic stress - Drought
Additional Information
Additional Information
type of decision: field trial
LMOs: Solanum tuberosum lines #2,#6 and #12, transformed with plasmid pBinAR-StSDD1,
Solanum tuberosum lines #1, #2, #7, #9, #11, transformed with plasmid pBinARHyg-AtSDD1
legal basis: Directive 2001/18/EC, Gentechnikgesetz [German Gene Technology Act]
scope: test of field performance of LMO
authorization valid from 01 April 2005 to 31 December 2008
locations: experimental field located in Brandenburg (Germany); for details see German LMO/GMO location register ( http://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
up to 1000 LMO/year of pBinARHyg-AtSDD1-plants and
up to 800 LMO/year of pBinAR-StSDD1-plants

There is a Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/04/159