Notification report

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
Field trial with SBVR111 x H7-1

Proposed period of release:
01/05/2013 to 31/12/2017

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

3. Is the same GMPt release planned elsewhere in the Community?

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

If yes, notification number(s):
B/CZ/10/3; B/ES/10/21-CON; B/ES/12/13; B/SE/07/12880;

Genetically modified plant

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

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
SBVR111xH7-1 sugar beet is a genetically modified sugar beet produced by conventional breeding crosses of SBVR111 and H7-1 sugar beet, which confer resistance to Rhizomania and tolerance to herbicide products containing glyphosate, respectively.

Rhizomania is a disease in sugar beet that is spreading rapidly and is induced by the Beet Necrotic Yellow Vein Virus (BNYVV). SBVR111 sugar beet expresses a gene (RZM) which confers resistance to the disease through interaction with the reproductive system of the virus that will lead to a reduction of the development of the virus in the plant. SBVR111 sugar beet also expresses a Phosphomannose Isomerase (PMI) protein, which acts as a selectable marker enabling transformed plant cells to utilize mannose as a primary carbon source.

H7-1 sugar beet expresses the CP4 EPSPS enzyme which confers the tolerance to glyphosate herbicides.

Genetic modification

3. Type of genetic modification:

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
SBVR111xH7-1 sugar beet is produced by conventional breeding crosses of SBVR111 and H7-1 sugar beet.
SBVR111 sugar beet was transformed with a plasmid carrying two genes:
- a gene that confers resistance to Rhizomania
- a gene that allows selection on media containing mannose.

DNA sequence Intended function Source
Ubiquitin 3 Promoter Arabidopsis thaliana
RZM Resistance to BNYVV BNYVV
Nos Terminator Agrobacterium tumefaciens
Hsp80 Promoter Brassica sp.
PMI Selectable marker E. coli
35S Terminator Cauliflower Mosaic Virus

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 single sugar beet events were 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 is to gain further information relating to the performance of SBVR111xH7-1 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 the target pest under European conditions. 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 lines 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.

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. Cross-pollination between SBVR111xH7-1 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. No adverse effects of SBVR111xH7-1 sugar beet on human health or the environment 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 flower is 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

European Commission administrative information

Consent given by the Member State Competent Authority:
17/04/2013 00:00:00