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Country's Decision or any other Communication
Record information and status
Record ID
103121
Status
Published
Date of creation
2012-02-20 14:02 UTC (german_bch@bvl.bund.de)
Date of last update
2017-05-31 08:35 UTC (german_bch@bvl.bund.de)
Date of publication
2017-07-13 15:43 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
6786-01-0166 (adv. 42010.0132); Decision regarding the deliberate release (field trial) of genetically modified potato (Solanum tuberosum) transformed with pPGBzep and pPGBzep-antisense issued by the German Competent Authority"
Date of the decision
2006-05-30
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
TU München
Lehrstuhl für Pflanzenzüchtung, Wissenschaftszentrum Weihenstephan für Ernährung, Landnutzung und Umwelt, Technische Universität München
Technische Universität München
Alte Akademie 8


Freising, Bayern
Germany, 85354
Phone:+49 8161 71 -3422,+49 8161 71 -3258
Fax:+49 8161 71-3900
Email:chris.schoen@wzw.tum.de,bork@wzw.tum.de,manuela.hochschulte@wzw.tum.de
Url:TU München, Lehrstuhl Pflanzenzüchtung,TU München - Wissenschaftszentrum Weihenstephan für Ernährung, Landnutzung und Umwelt
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
1. 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. The label need to distinctively describe the LMO and it needs to be noted that this potato is unfit for consumption. Transgenic and non transgenic potatos have to be stored separately.
2. 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 monthly after the experimental release. In case of any risk sufficient risk measures have to be performed.
3. Monthly inspection of the surrounding area [30 m] of the release site for transgenic potato volunteers and their removal and disposal.
4. After harvest the first 15-20 cm of upper soil of the release site have to be loosen up. Potatoes that emerge during that procedure have to be manually collected, removed, and destroyed by disruption of their germination capacity (heat, chopping, squeezing).
5. All machines that have been used on the release site have to be thoroughly cleaned on the release site.
6. After completion of the field trial monthly inspection of release site and surrounding areas [30 m] for transgenic potato volunteers, their documentation and removal and disposal has to be accomplished for one year. The inspection period has to be extended for another year if volunteers were observed. The release site must not be cultivated with plants impairing the detection of transgenic volunteers. 
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 Modified for reduced expression of Zeaxanthin epoxidase
TU München Changes in quality and/or metabolite content - Pigmentation / Coloration Resistance to antibiotics - Kanamycin Tolerance to abiotic stress
Show detection method(s)
Potato Modified for reduced expression of Zeaxanthin epoxidase
TU München Changes in quality and/or metabolite content - Pigmentation / Coloration Resistance to antibiotics - Kanamycin Tolerance to abiotic stress
Show detection method(s)
Risk assessment
6786-01-0166; Summary of the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum) transformed with pPGBzep and pPGBzep-antisense issued by the German Competent Authority
Potato Modified for reduced expression of Zeaxanthin epoxidase
TU München

Changes in quality and/or metabolite content - Pigmentation / Coloration
Resistance to antibiotics - Kanamycin
Tolerance to abiotic stress
Potato Modified for reduced expression of Zeaxanthin epoxidase
TU München

Changes in quality and/or metabolite content - Pigmentation / Coloration
Resistance to antibiotics - Kanamycin
Tolerance to abiotic stress
Additional Information
Additional Information
- type of decision: field trial
- LMO: potato (Solanum tuberosum) transformed with pPGBzep and pPGBzep-antisense
- legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
- scope: test of field performance of LMO
- authorization valid in the vegetation periods of the years 2006 and 2007
- locations: 2 experimental fields located in 2 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?)
- On each field side 162 m² per transgenic line will be cultivated with 4.5 potato plants per m²

- Publications regarding this field trial:
Römer S, Lübeck J, Kauder F, Steiger S, Adomat C, Sandmann G (2002) Genetic engineering of a zeaxanthin-rich potato by antisense inactivation and co-suppression of carotenoid epoxidation, Metab Eng., 4(4),263-72

Weinert N, Meincke R, Gottwald C, Radl V, Dong X, Schloter M, Berg G, Smalla, K (2010) Effects of genetically modified potatoes with increased zeaxanthin content on the abundance and diversity of rhizobacteria with in vitro antagonistic activity do not exceed natural variability among cultivars, Plant and Soil, 326 (1), 437-452