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Risk Assessment
Record information and status
Record ID
Date of creation
2010-06-03 10:34 UTC (german_bch@bvl.bund.de)
Date of last update
2020-06-11 15:02 UTC (german_bch@bvl.bund.de)
Date of publication
2020-06-12 06:44 UTC (nina.opitz@bmel.bund.de)

This document is also available in the following languages:
General Information
  • Germany
Title of risk assessment
6786-01-0159 (adv. 42010.0159); Summary of the risk assessment of a deliberate release (field trial) of genetically modified potatoes (Solanum tuberosum) transformed with plasmids pBinAR-StSDD1 and pBinARHyg-AtSDD1, issued by the German Competent Authority
Date of the risk assessment
Competent National Authority(ies) responsible for the risk assessment
Federal Office of Consumer Protection and Food Safety
Mauerstrasse 39-42
Germany, 10117
Url:http://www.biosafety-bch.de (english language),BVL Homepage (English)
Risk assessment details
Methodology and points to consider
Potential adverse effects identified in the risk assessment
The execution of this field trial is not expected to have a negative impact on human or animal health, or on the environment.
Estimation of the overall risk
Adverse effects on human or animal health or on the environment are not expected.
Receiving environment(s) considered
1 field site in Germany, details see German LMO/GMO location register (German language only) (http://apps2.bvl.bund.de/stareg_web/showflaechen.do)
LMO detection and identification methods proposed
PCR-based method, construct-specific
Additional Information
Additional Information
In these genetically modified potatoes the guard cell density is altered. This influences the gas exchange and water consumption of the plants and hence their growth under given weather conditions.

The modified potato plants were selected using the nptII-gene product NPT or the hph-gene product hygromycin phosphotransferase. Hence the plants must be considered to be resistant against antibiotics like neomycin, kanamycin or hygromycin.

The genetically modified potatoes harvested in the field trials are not intended for use in the production of foodstuffs or animal feed. Within the scope of the proposed release the alteration of the gas exchange and/or water consumption of the genetically modified potato plants is not expected to pose any threat to human or animal health, or to the environment. No new proteins will be generated in the plant as a consequence of the genetic modification.

In Europe the establishment of potatoes in natural ecosystems has not been observed, since potatoes compete poorly against wild plants and they are not frost resistant. From time to time potato plants are found beyond the cultivated areas, but only on non-natural sites such as verges and other ruderal areas. Owing to the lack of frost hardiness the cultivated potato does not establish in these areas either.

Potato plants can blossom and bear fruit. However, under Central European climate conditions there is little likelihood that potato seeds will overwinter and produce plants.

Attempts to cross-breed potatoes with solanaceous plants found in Central Europe were not successful. In agricultural practice, potatoes are propagated vegetatively via tubers. The pollen of the potato plant can be transferred by insects or by wind. However, wind dispersal only takes place over short distances. Pollen transfer, therefore, would have no effect on the results of cultivation.

The mode of action of the inserted genes and of its products is not expected to have a negative impact on human or animal health, or on the environment.

Provisions to be adopted during the course of and after finishing the field trial will limit the possibility of interaction with other plant species and crops.

The genetically modified potatoes referred to in the proposed field trial are not intended for use in foodstuffs or animal feed.

The field trial aims at validating the expected effect of the genetic modificaion under field conditions.

Field trial, not for human consumption or for feed purposes

An English summary of the notification including the risk assessment of the notifier is available at the EU WebSNIF internet-page of Joint Research Centre under notification number B/DE/04/159 (see below)

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