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Risk Assessment generated by a regulatory process
(RA)
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published: 28 Feb 2005
last updated: 25 Sep 2012
Application for the release into the environment of potato event EH92-527-1 under 2001/18/EC part B
EN
07 Apr 2004
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Competent National Authority:Ministry of Infrastructure and Watermanagement ()Rijnstraat 8 2515 XPThe Hague, South Holland
P.O.Box 20901, Netherlands (Kingdom of the)Phone: +316 21463694,Fax:Email: terrens.saaki@minienw.nl,
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BPS-25271-9 - Amflora™Potato| Reduced amylose in starch content, Resistance to antibiotics (Kanamycin)
- SNIF B/NL/03/09 [ English ]
EN
Potato has no wild relatives in Northwest Europe, outcrossing to those relatives is therefore irrelevant. Due to the combination of the climatic conditions in Northwest Europe and the Good Agricultural Practice potato is biologically contained.
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The risk of any adverse effect is considered to be neglilible.
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The field trials will be conducted in the northeast part of the Netherlands. Under these conditions potato is biologically contained.
In this region commercial cultivation of (starch)potatoes occurs also.
EN
In this region commercial cultivation of (starch)potatoes occurs also.
The event EH92-527-1 can be identiefied and detected either via a PCR based method or via iodine staining using diluted (1:2) Lugols solutions (2 g KI, 1 g I2 in 300 ml water) of the cut potato tuber surface. Conventional starch potatoes turn blue or blue-violet when stained with iodine. Amylopectin potatoes turn either brown or reddish-brown in colour. Tissue cab be scraped off and starch granules viewed under a microscope.
The PCR based method may be used as a reliable unique identification method. (See for more details notification C/SE/96/3501 at the JRC website.)
EN
The PCR based method may be used as a reliable unique identification method. (See for more details notification C/SE/96/3501 at the JRC website.)
The genetically modified potato line shows a shift of the tuber starch composition to amylopectin. No difference regarding persistence in agricultural habitats or invasiveness in natural habitats compared to conventional potato varieties is expected. Nor is it expected that a selective advantage or disadvantage is conferred to the GM lines via the introduced traits. Interactions of the GM potato lines with non-target species and resulting effects will be comparable to those of conventional potato varieties. No toxic or allergenic effects are expected from elevated levels of amylopectin starch, nor from the neomycin phosphotransferase. Measures in place under current field trial practice will protect the trial from damage by animals as well as safeguard that all seed and plant material is properly managed, harvested, stored, transported or disposed of to minimize or prevent contact to humans or animals. No effects are expected on biogeochemical processes. The GM potato lines will be cultivated under conventional agricultural practices.
Comprehensive data from previous releases have shown that potato clone EH92-527-1 is compositionally – with the exception of the modified starch structure - as well agronomically equivalent to the parent variety Prevalent. There is no evidence that insects associated with the GM clone are more or less abundant compared with the non-GM parent. The GM clone is no more susceptible or resistant to aphids, leafhoppers, larvae, worms, snails or potato cyst nematodes than the parent variety. Similarly there is no evidence for modified susceptibility to Phytophthora, Erwinia, Alterniaria and the viruses PVP, PLRV, PMTV and TRV. No adverse impacts on the environment and human health were observed during any field trials carried out so far.
The release is foreseen as part of the application process for variety registration and variety protection of potato event EH92-527-1.
An English summary of the notification including the risk assessment is available at the EU WebSNIF internetsite EC-JRC GMO Register under notification number B/NL/03/09.
The consent is available at
http://www.ggo-vergunningverlening-zoeken.nl (notification number IM 03-009) (only in Dutch).
The same event is also notified for placing on the market. Information concerning the placing on the market is also available at the WebSNIF internetsite (http://gmoinfo.jrc.it) under notification number C/SE/96/96/3501.
EN
Comprehensive data from previous releases have shown that potato clone EH92-527-1 is compositionally – with the exception of the modified starch structure - as well agronomically equivalent to the parent variety Prevalent. There is no evidence that insects associated with the GM clone are more or less abundant compared with the non-GM parent. The GM clone is no more susceptible or resistant to aphids, leafhoppers, larvae, worms, snails or potato cyst nematodes than the parent variety. Similarly there is no evidence for modified susceptibility to Phytophthora, Erwinia, Alterniaria and the viruses PVP, PLRV, PMTV and TRV. No adverse impacts on the environment and human health were observed during any field trials carried out so far.
The release is foreseen as part of the application process for variety registration and variety protection of potato event EH92-527-1.
An English summary of the notification including the risk assessment is available at the EU WebSNIF internetsite EC-JRC GMO Register under notification number B/NL/03/09.
The consent is available at
http://www.ggo-vergunningverlening-zoeken.nl (notification number IM 03-009) (only in Dutch).
The same event is also notified for placing on the market. Information concerning the placing on the market is also available at the WebSNIF internetsite (http://gmoinfo.jrc.it) under notification number C/SE/96/96/3501.
- Dutch National GMO Register (in Dutch) [ English ]
- EC-JRC GMO Register [ English ]