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Country's Decision or any other Communication
Record information and status
Record ID
103662
Status
Published
Date of creation
2012-06-28 11:07 UTC (german_bch@bvl.bund.de)
Date of last update
2017-05-31 13:08 UTC (german_bch@bvl.bund.de)
Date of publication
2017-07-13 15:46 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
6786-01-0183; Decision regarding the deliberate release (field trial) of genetically modified potatoes (Solanum tuberosum, cultivars P800, P763, P698, P835, P880) transformed with pAP2, pAP4, pHAS3, VCPMA16 or VCPMA19 issued by the German Competent Authority"
Date of the decision
2007-04-19
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
BASF Plant Science GmbH
Carl-Bosch-Str. 38
Ludwigshafen
Germany, 67056
Phone:+49 621 60-0
Fax:+49 621 60-42525
Email:global.info@basf.com
Url:BASF AG - Pflanzenbiotechnologie
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
- Fertile plant material (potato tuber) has to be transported and stored in closed and clearly labelled repositories at any time outside the release site and laboratory and has to kept separately from non transgenic potatoes. The label need to distinctively describe the LMO and it needs to be noted that this potato is unfit for consumption (food and feed). All remaining fertile plant material has to be destroyed by disruption of their germination capacity.
- Inspection of release site on unexpected biological traits of the LMO and reciprocal effects between LMO and other organisms has to be accomplished weekly during the experimental release and if required sufficient risk measures have to be performed.
- During and after the field trial monthly inspection of the surrounding area [10 m] of the release site for transgenic potato volunteers and their manual removal and disposal has to be accomplished.
- All transgenic potatoes that are not intended to be used for further cultivation or analysis as well as transgenic potatoes that are found when cleaning the working equipment have to be disposed by disruption of their germination capacity.
- After harvest and in the following spring the first 20 cm of the soil of the release site has to be loosen up and uncovered potatoes as well as potatoes that are found on the working equipment have to be collected and disposed by disruption of their germination capacity. The release site must not be ploughed.
- After completion of the field trial an inspection of the release site for one year on transgenic potato volunteers, their removal and disposal has to be accomplished during the growing season every 4 weeks. If experimental release involved overwinter survival trials inspection of the release site has to be performed from May to December after harvest. The inspection period has to be extended for another year if potato volunteers were observed. The release site must not be cultivated with plants impairing the detection of transgenic volunteers. 
- A sign indicating "Versuchspflanzen, nicht zum Verzehr oder zur Verfütterung geeignet" (test plants, unfit for use as food and feed) has to be put up at the release site.
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
Potato with altered starch content
BASF Plant Science GmbH altered carbohydrate composition: increased amylopectin content Resistance to herbicides - Imidazolinone, Sulfonylurea
Potato modified for altered starch content
BASF Plant Science GmbH altered carbohydrate composition: increased amylopectin content Resistance to herbicides - Imidazolinone, Sulfonylurea
Potato with modified starch composition
BASF Plant Science GmbH altered carbohydrate composition: increased amylopectin content Resistance to herbicides - Imidazolinone, Sulfonylurea
Show detection method(s)
Potato modified for resistance to Phytophthora infestans
BASF Plant Science GmbH Resistance to diseases and pests - Fungi Resistance to herbicides - Imidazolinone, Sulfonylurea
Show detection method(s)
Potato modified for resistance to Phytophthora infestans
BASF Plant Science GmbH Resistance to diseases and pests - Fungi Resistance to herbicides - Imidazolinone, Sulfonylurea
Show detection method(s)
Risk assessment
6786-01-0183; Summary of the risk assessment of a deliberate release (field trial) of genetically modified potatoes (Solanum tuberosum, cultivars P800, P763, P698, P835, P880) transformed with pAP2, pAP4, pHAS3, VCPMA16 or VCPMA19 issued by the German Competent Authority
Potato with altered starch content
BASF Plant Science GmbH

altered carbohydrate composition: increased amylopectin content
Resistance to herbicides - Imidazolinone, Sulfonylurea
Potato modified for altered starch content
BASF Plant Science GmbH

altered carbohydrate composition: increased amylopectin content
Resistance to herbicides - Imidazolinone, Sulfonylurea
Potato with modified starch composition
BASF Plant Science GmbH

altered carbohydrate composition: increased amylopectin content
Resistance to herbicides - Imidazolinone, Sulfonylurea
Potato modified for resistance to Phytophthora infestans
BASF Plant Science GmbH

Resistance to diseases and pests - Fungi
Resistance to herbicides - Imidazolinone, Sulfonylurea
Potato modified for resistance to Phytophthora infestans
BASF Plant Science GmbH

Resistance to diseases and pests - Fungi
Resistance to herbicides - Imidazolinone, Sulfonylurea
Additional Information
Additional Information
- type of decision: field trial
- LMO: potatoes (Solanum tuberosum, cultivars P800, P763, P698, P835, P880) transformed with pAP2, pAP4, pHAS3, VCPMA16 or VCPMA19
- legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
- scope: test of field performance of LMO
- authorization valid within the vegetation periods between 2007 and 2011
- locations: 10 experimental fields located in 10 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: overall 147 ha with ca. 45,000 plants/ha