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 NK603 maize for the use in field trials in Denmark

Proposed period of release:
01/04/2011 to 31/12/2015

Name of the Institute(s) or Company(ies)
Monsanto Company, Represented by Monsanto Crop Sciences Danmark A/S;

3. Is the same GMPt release planned elsewhere in the Community?
Germany; Denmark; Spain; France; Czech Republic; Poland; Slovak Republic; Romania;

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

If yes, notification number(s):
B/BE/00/WSP13; B/CZ/06/04; B/DE/00/115; B/DE/03/148; B/DK/07/01; B/DK/07/02; B/DK/07/03; B/DK/07/04; B/DK/09/02; B/DK/09/03; B/DK/09/04; B/ES/00/06; B/ES/01/05; B/ES/02/03; B/ES/04/17; B/ES/04/19; B/ES/06/06; B/ES/06/08; B/ES/07/05; B/ES/07/07; B/ES/08/06; B/ES/09/04; B/FR/00/03/05; B/FR/01/01/01; B/FR/04/02/02; B/FR/06/01/01; B/FR/06/12/09; B/FR/99/04/06; B/IT/99/17; B/PT/09/01; B/PT/10/01; B/RO/08/09; B/RO/09/19; B/RO/10/03; B/SE/05/9831; B/SK/06/01; B/SK/08/03; B/SK/10/04;

Other notifications
NK603 has been notified for field-testing in the E.U. since 1999 (see Monsanto Part B notification numbers)

Other notifications:

26OA/OER/GMO/02 (Czech Republic)
IM-07-008 (NL)
82/2008 (PL)
02-1/2009 (PL)

Genetically modified plant

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

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:

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:
Genetic Element Source Size (kb) Function
First cp4 epsps gene cassette

ract1 intron Oryza sativa 1,4 Contains promoter, trans
scription start site and
First intron

Ctp 2 Arabidopsis 0,2 Encodes chloroplast tran
thaliana sit peptide, which di-
rects the CP4 EPSPS pro-
tein to the cholorplast

cp4 epsps Agrobacterium 1,4 Encodes glyphosate-tole-
sp. strain CP4 rant CP4 EPSPS protein

NOS 3’ Agrobacterium 0,3 Ends transcription and
tumefaciens directs polyadenylation

Second cp4 epsps gene cassette

e35S Cauliflower 0,6 Promoter
mosaic virus

Zmhsp70 Zea mays L. 0,8 Stabilizes the
level of gene

Ctp 2 Arabidopsis 0,2 Encodes chloro-
thaliana plast transit peptide
which directs the CP4
EPSPS protein to the

cp4 epsps l214p Agrobacterium 1,4 Encodes glyphosate-
sp. strain CP4 tolerant CP4 EPSPS
L214P protein

NOS 3’ Agrobacterium 0,3 Ends transcrip-
tumefaciens tion and directs
0.3 polyadenylation
and directs

6. Brief description of the method used for the genetic modification:
NK603 maize was modified by insertion of a DNA fragment into the maize genome using a particle acceleration method.
The introduced DNA fragment consists of two adjacent plant gene expression cassettes, each containing a single copy of the cp4 epsps gene. The introduced cp4 epsps gene encodes a tolerant form of EPSPS, which confers glyphosate tolerance to the plant. This gene was derived from a common soil-borne bacterium, Agrobacterium sp. strain CP4. The source vector, plasmid PV-ZMGT32, containing this fragment, was developed by Monsanto Company.

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:
Test of maize varieties (of the type NK603) tolerant to the glyphosate herbicide Roundup® in order to obtain variety approval.

2. Geographical location of the site:
West Jutland

3. Size of the site (m2):
Up to 2 ha per year.

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:
Multi-year field-testing in the E.U. (see question A4) and post-marketing experience in other world areas since 2001 provided no significant evidence that NK603 could pose any risk of adverse effects to human or animal health or to the environment.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Analysis of the characteristics of NK603 has shown that the risk of potential adverse effects on human and animal health and the receiving environment, resulting from the deliberate release of this maize for field testing, is consistently negligible:
The risk of the introduced trait in NK603 maize to be the cause of any meaningful competitive advantage or disadvantage in natural environments is negligible. As for any other maize, the likelihood of this maize to spread into non-agronomic environments is negligible, as its persistence in agricultural habitats and its invasiveness into natural habitats is unaltered compared to conventional maize.
NK603 maize is herbicide-tolerant and, as such, has no target organisms. Potential exposure of non-target organisms to CP4 EPSPS presents no conceivable mechanism to cause adverse effects because of its properties. The interaction between this maize and non-target organisms is not different from conventional maize. Therefore, the environmental risk of adverse effects on biochemical processes, caused by the interaction of NK603 with decomposers and interacting detritivores in the soil compartment, is negligible. Additionally, as CP4 EPSPS proteins belong to a well-known, safe class of EPSPS proteins
that are commonly found in bacteria, fungi, algae and in all higher plants, soil microorganisms have historically been exposed to a diversity of naturally occurring EPSPS proteins.
Any occupational health aspects of handling NK603 maize are no different from conventional maize, and this maize was shown to be as safe and as nutritious as any other maize, 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 maize.
It is actually expected that the commercial production of NK603 will positively impact current agronomic practices in maize and provide benefits to farmers and the environment. The use of glyphosate in maize enables the farmer to take advantage of the herbicide’s favourable environmental and safety properties (see Annex I listing of glyphosate under Council Directive 91/414/EEC). Roundup-tolerant maize benefits the farmer by providing (1) an additional broad-spectrum weed control option in maize, (2) a new herbicidal mode of action for in-season maize weed control, (3) increased flexibility to treat weeds on an “as needed” basis, (4) cost-effective weed control and (5) an excellent fit with reduced-tillage systems. In turn, a number of environmental benefits arise from the use of conservation tillage including improved soil quality, improved water infiltration, reductions in erosion and sedimentation of water resources, reduced runoff of nutrients and pesticides to surface water, improved wildlife habitat, increased carbon retention in the soil, reduced fuel use and encouragement of sustainable agricultural practices.

Brief description of any measures taken for the management of risks:
The environmental risk assessment has indicated that the environmental risks of this maize are negligible. Therefore, strategies for risk management for NK603 would be the same as for traditional maize.
However, in addition to the scheduled observations of agronomic parameters that form the basis of the planned research, the trial site will be checked regularly during the period of the deliberate release for potentially occurring, direct or indirect, adverse effects. This will be done by visual inspection of the status of the NK603 crop and that of its receiving environment.
In case any adverse environmental effects, linked to the deliberate release of NK603, are observed during the period of release, these will be reported immediately to the Competent Authority.
At the end of the field-testing campaign, a report of will be made available by the notifier to the Competent Authority. This report will detail any unexpected adverse environmental effects that were observed during the general surveillance, if any, and further actions elicited as an effect of these findings, if applicable.
The field trials will be no less than 200 m from other unregulated maize fields, and will be surrounded by a border of conventional maize.
The products from the trials may be used for analysis and will not be used for human food or animal feed.
Volunteer surveillance program will be implemented. The year following the planned trial,
the site will be scouted for the presence of any maize volunteers that could contain the traits expressed in NK603, and any volunteer will be removed. The year following harvest of GM maize trial, maize will not be grown on the trial site.

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable.
However, any unanticipated adverse effects on human health or the environment would be reported immediately to the Competent Authority.

Final report

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known