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Risk Assessment
Record information and status
Record ID
101210
Status
Published
Date of creation
2010-06-02 07:27 UTC (german_bch@bvl.bund.de)
Date of last update
2020-06-11 14:29 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
Country
  • Germany
Title of risk assessment
6786-01-0186 (adv. 42010.0186); Summary of the risk assessment of a deliberate release (field trial) of genetically modified potatoes (Solanum tuberosum) "EH92-527-1" (BPS-25271-9), issued by the German Competent Authority
Date of the risk assessment
2007-05-25
Competent National Authority(ies) responsible for the risk assessment
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)
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
3 field site in Germany, details see German LMO/GMO location register ( https://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
LMO detection and identification methods proposed
PCR-based method, event-specific, submitted with a notification for placing on the market under Regulation (EU) Nr. 1829/2003, available at: http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
Additional Information
Additional Information
In this genetically modified potato the endogenous transcript of the gbss gene is inactivated, thereby inhibiting the pro-duction of the GBSS enzyme.
Due to the decreased amount of GBSS protein, a starch with reduced amylose content (amy-lopectin starch) is synthesised in the tubers.

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

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 starch composition 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 the multiplication of seed potatoes for the expected authorisation of cultivation in the European Union.

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/06/186 (see below)

This LMO is authorised for placing on the market in the EU for cultivation, food, feed and processing purposes, too. Further information is available at the internet-page of the European Commission (http://ec.europa.eu/food/dyna/gm_register/index_en.cfm)

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