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
Notification according to Directive 2001/18/EC, Part B, for the deliberate release of H7-1 sugar beet for the use in field trials in Sweden.

Proposed period of release:
01/04/2012 to 31/12/2016

Name of the Institute(s) or Company(ies)
Monsanto Crop Sciences Sweden AB, Monsanto Crop Sciences Sweden AB
Ekbacksvägen 28
Bromma S-168 69

On behalf of: Monsanto Europe SA, 270-272 Ave de Tervuren, 1150 Bryssel, Belgien;

3. Is the same GMPt release planned elsewhere in the Community?
Germany; Denmark; Czech Republic;

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

If yes, notification number(s):
B/BE/00/VSP2; B/BE/95/WSP4; B/CZ/10/2; B/DE/07/192; B/DE/10/211; B/DE/99/94; B/DK/11/01; B/ES/00/08; B/ES/06/01; B/ES/08/01; B/ES/08/35; B/ES/09/28; B/ES/10/01; B/ES/10/02; B/ES/10/20; B/ES/11/02; B/ES/11/04; B/ES/11/15; B/ES/99/03; B/FR/00/07/01; B/FR/97/10/11; B/FR/99/01/07; B/FR/99/11/02; B/GB/96/R22/7; B/GB/98/R22/11; B/IT/97/18; B/IT/99/03; B/IT/99/27; B/IT/99/36; B/NL/96/22; B/NL/96/22-EXT1; B/PL/09/02-06; B/RO/11/02; B/SE/04/7951; B/SE/10/129; B/SK/10/01;

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
sugar beetchenopodiaceaebetabeta vulgarisvulgaris var. saccharifera3S0057 (2n=18)

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
H7-1 expresses the CP4 EPSPS protein, derived from Agrobacterium sp. strain CP4, which provides tolerance to glyphosate.

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:
H7-1 contains the cp4 epsps gene which codes for the CP4 EPSPS protein derived from Agrobacterium sp. strain CP4. This protein confers tolerance to glyphosate.
A full description of the genetic elements in H7-1, including the approximate size, source and function is provided in Table 1.

Table 1. Summary of genetic elements inserted in H7-1

Genetic elements, Size(kb), Function,

Right border, 0.025, A 21-25 bp nucleotide sequence that acts as the initial point of DNA transfer into plant cells originally isolated from A. tumefaciens pTiT37

P-FMV, 0.672, The 35S promoter from a modified Figwort Mosaic Virus (FMV)

ctp2, 0.31, Sequences encoding the chloroplast transit peptide from the ShkG gene of Arabidopsis thaliana encoding EPSPS

cp4 epsps, 1.363, The 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) coding sequence from Agrobacterium sp. strain CP4

E9 3’, 0.63, 3' nontranslated sequence from the ribulose-1,5-bisphosphate carboxylase small subunit (rbcs2) E9 gene of pea (Pisum sativum)

Left border, 0.025, A 21-25 bp nucleotide sequence that delimits the T-DNA transfer into plant cells, originally isolated from A. tumefaciens plasmid pTi15955, a derivative of the octopine type plasmid pTiA6

6. Brief description of the method used for the genetic modification:
H7-1 was produced by Agrobacterium-mediated transformation of cotyledons of sterile sugar beet seedlings.

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

Experimental Release

1. Purpose of the release:
The objective of the field releases is to evaluate Roundup efficacy and agronomic performance in H7-1 RR sugar beet

2. Geographical location of the site:
The releases will take place in Kävlinge, Lund, Staffanstorp, Svedela och Kristianstad.

3. Size of the site (m2):
The total size per year will be maximum 30 000 m2

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:
H7-1 sugar beet has been notified in Belgium, United Kingdom, Italy, the Netherlands, France, Germany and Spain under Part B of Directive 90/220/EEC and 2001/18/EC (see Table 2). Furthermore, H7-1 has been released for field-testing at several locations in the U.S.A., Canada, Russia, Chile, Czech Republic and Poland since 1998. These field trials were conducted to produce material for the regulatory studies and to assess agronomic performance (efficacy, selectivity, yield assessment).
Following rigorous regulatory assessment, environmental authorizations have been received in the U.S.A. (2005), Canada (2005), and Japan (2007) for H7-1 sugar beet.
The results of the described field-testings and post-marketing experience in these countries showed no evidence that H7 1 is likely to cause any adverse effects to human or animal health and the environment. Except for its tolerance to glyphosate, H7-1 could not be distinguished from conventional sugar beet.

Table 2. List of previous notifications under Part B of Directive 90/220/EEC and 2001/18/EC
Year Country Notification Number

1995 Belgium B/BE/95/WSP4 (Monsanto)

1996 Belgium B/BE/95/WSP4 (Monsanto)
United Kingdom B/GB/96/R22/7 (96/R 22/7) (Monsanto)

1997 Belgium B/BE/95/WSP4 (Monsanto)
Italy B/IT/97/18 (Monsanto)
The Netherlands B/NL/96/22 (BGGO 96/22) (Monsanto)

1998 Belgium B/BE/95/WSP4 (Monsanto)
Italy B/IT/97/18 (Monsanto)
France B/FR/97/10/11 (Monsanto)
The Netherlands B/NL/96/22 (BGGO 96/22) (Monsanto)
United Kingdom B/GB/98/R22/11 (B/UK/98/R22/11) (Monsanto)

1999 Belgium B/BE/95/WSP4 (Monsanto)
France B/FR/99/01/07 (Monsanto/KWS)
France B/FR/99/11/02 (KWS)
Germany B/DE/99/94 (ZG2 6786-01-0094) (Monsanto)
Italy B/IT/97/18 (Monsanto)
Italy B/IT/99/03 (KWS)
Italy B/IT/99/27 (KWS)
Italy B/IT/99/36 (KWS)
Spain B/ES/99/03 (Monsanto)
The Netherlands B/NL/96/22-EXT1 (BGGO 96/22-01) (Monsanto)
United Kingdom B/GB/98/R22/11 (B/UK/98/R22/11) (Monsanto)

2000 Belgium B/BE/95/WSP4 (Monsanto)
Belgium B/BE/00/VSP2 (KWS)
France B/FR/99/01/07 (Monsanto/KWS)
France B/FR/00/07/01 (KWS)
Germany B/DE/99/94 (ZG2 6786-01-0094) (Monsanto)
Spain B/ES/00/08 (Monsanto)
The Netherlands B/NL/96/22-EXT1 (BGGO 96/22-01) (Monsanto)

2001 Belgium B/BE/95/WSP4 (Monsanto)
France B/FR/99/01/07 (Monsanto/KWS)
Germany B/DE/99/94 (ZG2 6786-01-0094) (Monsanto)
The Netherlands B/NL/96/22-EXT1 (BGGO 96/22-01) (Monsanto)

2002 Germany B/DE/99/94 (ZG2 6786-01-0094) (Monsanto)

2005 Sweden B/SE/04/7951 (Syngenta Seeds)

2006 Spain B/ES/06/01 (Monsanto)

2008 Germany B/DE/07/192 (Planta KWS)
Spain B/ES/08/01 (Monsanto)
Spain B/ES/08/35 (Syngenta Seeds)

2009 Spain B/ES/09/28 (Sesvanderhave)

2010 Czech Republic B/CZ/10/2 (Sesvanderhave)
Poland B/PL/09/02-06 (Wroclaw University)
Slovakia B/SK/10/01 (Sesvanderhave)
Spain B/ES/10/01 (KWS)
Spain B/ES/10/02 (Sesvanderhave)
Spain B/ES/10/20 (Syngenta)
Sweden B/SE/10/129 (Syngenta)

2011 Denmark B/DK/11/01 (Monsanto)
Germany B/DE/10/211 (Monsanto)
Romania B/RO/11/02 (Monsanto)
Spain B/ES/11/04 (Monsanto)
Spain B/ES/11/02 (KWS)
Spain B/ES/11/15 (Sesvanderhave)

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Analysis of the characteristics of H7-1 has shown that the risk of potential adverse effects on human health or the environment, resulting from the deliberate release of this sugar beet for field testing, is negligible:
• The risk of the introduced trait in H7-1 to be the cause of any meaningful competitive advantage or disadvantage in natural environments is negligible. The likelihood of unintended spreading of H7-1 in the non-agricultural environments is negligible, as sugar beet is neither persistent nor invasive and these parameters are unaltered when compared to conventional sugar beet.
• Outcrossing will be negligible since this application is for consent to cultivate H7-1 sugar beet for trial purposes, implying that sugar beet is grown for its vegetative root and the lifecycle is limited to the vegetative stage in agricultural production. Nevertheless, measures will be taken to avoid hybridization with other sugar beet plants and seed dissemination at harvest and during transportation (see Point E).
• As H7-1 sugar beet is herbicide tolerant it has no target organisms with which to interact, either directly or indirectly. Therefore, no characteristics that may cause any adverse environmental effects could be identified.
• Based on the well-characterised mode of action of the EPSPS enzymes and the confirmation through studies of no adverse effects found, it is highly unlikely that H7-1 sugar beet would be hazardous to non-target organisms. The ecological interactions with non-target organisms or the biochemical processes in soil are considered similar to the ones caused by conventional sugar beet.
• Any occupational health aspects of handling H7-1 are not different from conventional sugar beet. Additionally this sugar beet was shown not to cause any toxic or allergenic effects in humans or animals and to be as safe and nutritious as any other sugar beet without any consequences for the feed/food chain.
• The environmental impact of the cultivation, management and harvesting techniques applied in the planned trials is considered no different from the cultivation of any other sugar beet.
Since no characteristics of H7-1 could be identified that may cause adverse effects on human health or the environment, no risk management strategies are considered necessary.

Brief description of any measures taken for the management of risks:
The H7-1 sugar beet will not be allowed to flower and set seed. The trial will be visited regularly, and bolting plants will be 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 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:
Not applicable.
However, any possible unforeseen adverse effects to human health or the environment will immediately be reported to the competent authority.

Final report

European Commission administrative information

Consent given by the Member State Competent Authority:
04/04/2012 00:00:00