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Notification report


General information

Notification Number
B/SE/15/4252

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
14/04/2015

Title of the Project
Field trial with Sugar beet H7-1

Proposed period of release:
01/06/2015 to 31/01/2019

Name of the Institute(s) or Company(ies)
Syngenta Seeds AB Sweden, on behalf of Syngenta Crop Protection AG, Basel Switzerland and all affiliated companies;


3. Is the same GMPt release planned elsewhere in the Community?
Not known

Has the same GMPt been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/CZ/10/3; B/ES/08/35; B/ES/09/45; B/ES/10/20; B/SE/04/7951; B/SE/10/129;

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
beetchenopodiaceaebetabeta vulgarisvulgaris

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
SB H7-1 is a genetically modified sugar beet that expresses the CP4 EPSPS enzyme which confers tolerance to glyphosate herbicides.

Genetic modification

3. Type of genetic modification:
Insertion;

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
H7-1 sugar beet:
a/ Vector component b/ Size (Kb) c/Function & source

1a/ Right Border 1b/ 0.025 1c/ A nucleotide sequence that acts as the initial point of DNA transfer into plant cells originally isolated from A. tumefaciens pTiT37

2a/ P-FMV 2b/ 0.672 2c/ The 35S promoter from a modified figwort mosaic virus (FMV) used to drive expression of cp4 epsps gene

3a/ ctp2 3b/ 0.31 3c/ The N-terminal chloroplast transit peptide sequence from the Arabidopsis thaliana epsps gene

4a/ cp4 epsps 4b/ 1.363 4c/ The 5-enolpyruvylshikimate-3-phosphate synthase (cp4 epsps) synthetic gene based on the sequence from Agrobacterium sp. strain CP4

5a/ E9 3’ 5b/ 0.63 5c/ The 3’ end of the Pisum sativum rbcS E9 gene which provides the polyadenylation sites for the cp4 epsps gene

6a/ Left Border 6b/ 0.025 6c/ A nucleotide sequence that delimits the T-DNA transfer into plant cells. It was originally isolated from A. tumefaciens pTiA6


6. Brief description of the method used for the genetic modification:
The sugar beet event was generated by standard Agrobacterium transformation techniques.

7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
Not applicable as the recipient or parental plant is not a forest tree species.

Experimental Release

1. Purpose of the release:
The objective of the field releases are to gain further information relating to the performance of H7-1 sugar beet under European conditions, to produce material for analysis and to study the agronomic performance as well as to gain further information relating to the performance against pest and diseases. They will also allow the further assessment of the event in the environment.

2. Geographical location of the site:
The release locations will be in Landskrona, Helsingborg, Svalöv, Simrishamn, Kävlinge, Lomma, Ystad, Eslöv, Lund and Kristianstad.

3. Size of the site (m2):
Per year, the maximal size will be 30.000 m2 this includes border rows.

4. Relevant data regarding previous releases carried out with the same GM-plant, if any, specifically related to the potential environmental and human health impacts from the release:
Evidence from previous field trials in the USA and EU indicates that the genetically modified line do not differ from the recipient plant in mode or rate of reproduction, dissemination or survivability of the plant. No environmental or human health negative impact has been reported from these trials or cultivations.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
An environmental risk assessment has been conducted for these small-scale field trials.
Sugar beet is non-invasive of natural habitats in Europe. Expression of the cp4 epsps in H7-1 sugar beet is very unlikely to result in any selective advantage or disadvantage when compared to conventional sugar beet, especially under the uses proposed in this application. These conclusions were based on the fact that (i) sugar beet is a highly domesticated plant and is unlikely to survive without human intervention and (ii) expression of the cp4 epsps protein could confer advantage to sugar beet plants when herbicide products containing glyphosate are applied; however this rarely happens outside agricultural environments. Therefore, expression of cp4 epsps is highly unlikely to confer selective advantage to sugar beet plants.
In addition, cross-pollination between H7-1 sugar beet and sexually compatible wild relatives or other sugar beet crops is unlikely to occur given the layout and the design of this small-scale field trials and because plants will not be allowed to flower and set seed. At the end of the trial any remaining plant materials will be destroyed so no GM sugar beet will be used for human food or animal feed. The following year any volunteer plants will be removed.
Field trials with H7-1 sugar beet have been conducted to date and no adverse effects on human or animal health effects have ever been reported.
H7-1 sugar beet has been approved for cultivation and food and feed use in countries like the US. It is also approved for food and feed use in the EU. No adverse effects on health have ever been reported.
No adverse effects of H7-1 sugar beet on human health or the environment as a results of these trials are therefore anticipated.
In summary, no immediate or delayed adverse effects as a result of the direct and indirect interaction of the genetically modified sugar beet with the environment when compared to non-modified sugar beet have been identified.


Brief description of any measures taken for the management of risks:
The GM sugar beet will not be allowed to flower and set seed. The trial will be visited regularly, and bolting plants will be mechanically removed, before any flowers are developed. This will prevent any spread of pollen.
The products from the trials may be used for analysis. Plant material remaining after sampling and harvest will be destroyed and will not be used for human food or animal feed.
The sites will be monitored for one year after the release and any volunteer sugar beet appearing will be eliminated before flowering. During this year, sugar beet will not be grown on the trial sites.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The trials have not been designed to specifically gain new data on the environment and human health impact of the release.
They will however allow the further assessment of the event in the environment.


Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
15/06/2015 00:00:00
Remarks:
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