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Country's Decision or any other Communication (DEC)
  |  
BCH-DEC-DE-103121-3   |   PDF   |   Print   |  
published: 20 Feb 2012 last updated: 31 Jul 2020
Amendment
No
General Information
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
EN
30 May 2006
No
Subject of the decision, notification, communication or declaration
  • Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)
LMOs for intentional introduction into the environment
No
No
Yes
No
No
Result of the decision
Approval of the import and/or use of the LMO(s) with 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. 
EN
To comply with requirements of Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-103102-3 Living Modified Organism Potato Modified for reduced expression of Zeaxanthin epoxidase
    Technische Universität München | accumulation of health improving secondary plant compounds (zeaxanthin), Changes in quality and/or metabolite content (Pigmentation / Coloration), Resistance to antibiotics (Kanamycin, Neomycin)
  • BCH-LMO-SCBD-103101-2 Living Modified Organism Potato Modified for reduced expression of Zeaxanthin epoxidase
    Technische Universität München | accumulation of health improving secondary plant metabolites (zeaxanthin), Changes in quality and/or metabolite content (Pigmentation / Coloration), Resistance to antibiotics (Kanamycin, Neomycin)
  • BCH-RA-DE-103119-4 Risk Assessment generated by a regulatory process 6786-01-0166 (adv. 42010.0166); 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 | Potato, SOLTU, Resistance to antibiotics, Changes in quality and/or metabolite content | Potato Modified for reduced expression of Zeaxanthin epoxidase | Potato, SOLTU, Resistance to antibiotics, Changes in quality and/or metabolite content
Document on the decision, communication, notification or declaration
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
EN