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Notification report


General information

Notification Number
B/CZ/13/01

Member State to which the notification was sent
Czech Republic

Date of acknowledgement from the Member State Competent Authority
04/11/2013

Title of the Project
Deliberate release of NK603 maize for field trials - continuation of the project B/CZ/06/04 on one site

Proposed period of release:
01/01/2014 to 31/12/2015

Name of the Institute(s) or Company(ies)
Czech University of Life Sciences, ;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Denmark; Spain; Slovak Republic; Romania;

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

If yes, notification number(s):
B/CZ/06/04; B/CZ/07/02;

Other notifications
NK603 has been notified for field-testing in the E.U. since 1999, in CZ B/CZ/06/04, B/CZ/07/02.
In addition, many field trials have already been conducted across maize growing
regions in North and South America and other world areas. NK603 has been
commercially released for cultivation in the US. And Canada, since 2001. In 2004, NK603 varieties were commercialised for the first time in Argentina and since 2009 it can be planted in Brazil. Sice 2010 several countries in the Americas (US, Canada, Colombia, Honduras, Brazil, Argentina), Asia (China, the Philippines) and Africa (South Africa) have cultivated this maize.


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:
The expression of CP4 EPSPS proteins in NK603 Roundup Ready maize plants imparts tolerance to glyphosate (N-phosphonomethyl-glycine), the active ingredient in the non-selective, foliarapplied, broad-spectrum, post-emergent herbicide Roundup®. EPSPS is an enzyme involved in the shikimic acid pathway for aromatic amino acid biosynthesis in plants and micro-organisms. CP4 EPSPS enzymes have been shown to have significantly reduced affinity for glyphosate when compared with the wild-type maize enzyme, and to retain
catalytic activity in the presence of the inhibitor glyphosate. Therefore, when maize plants expressing the CP4 EPSPS proteins are treated with glyphosate, the plants are unaffected since the continued action of the tolerant CP4 EPSPS enzymes provides for the plant’s need for aromatic amino acids.


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:
CS4-cp4 epsps DNA sequence coding for the native CP4 EPSPS protein
T5-nos 3' transcript termination sequence of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation
P-e35S Promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA containing the duplicated enhancer region
I-Hsp70 Intron from the maize heat-shock protein 70 gene
TS-CTP2 DNA sequence coding for the N-teminal chloroplast transit peptide
CS-cp4 epsps l214p DNA sequence coding for the CP4 EPSPS L214P protein
T-nos 3' transcript termination sequence of the nopaline
synthase (nos) coding sequence from Agrobacterium


6. Brief description of the method used for the genetic modification:
NK603 parental maize line was genetically modified using a particle acceleration method.

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:
NK603 will be planted in field trials for assessment of the following criteria: weed treatment strategies in maize, insect abundance under different soil tillage conditions and different herbicide treatments and biological efficacy.

2. Geographical location of the site:
Odrepsy, Stredocesky Region

3. Size of the site (m2):
Maximum 30 000 m2 will be sown with GM maize.

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:
Post-release general surveillance from environments inside and outside the
E.U. has shown that NK603 maize is unlikely to pose any risk of adverse effects
to human or animal health or to the environment.
NK603 maize was approved on 19 July 2004 for import, feed use and processing in the EU under Directive 2001/18/EC (Commission Decision 2004/643/EC). Food and food ingredients derived from NK603 were approved under Regulation (EC) No. 258/97 (Commission Decision 2005/448/EC) and existing feed materials, feed additives and food additives produced from NK603 were listed in the Community Register, according to Regulation (EC) No. 1829/2003 . An application for cultivation of varieties of NK603 in the European Union was submitted under Regulation (EC) No. 1829/2003 and EFSA adopted a favourable scientific opinion (published on 11 June 2009) concluding that NK603 is as safe as its conventional counterpart with respect to potential direct effects on human and animal health and 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 maize, especially in comparison with extensive experience with cultivation of traditional maize within the EU, has shown that the risk for potential adverse effects on human and animal health and the receiving environment, resulting from the planned field trials with NK603 maize, is acceptable because:
- The risk of the introduced trait in NK603 maize to be the cause of any meaningful competitive advantage or disadvantage in natural environments has not been found. 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 are unaltered compared to traditional maize.
- Potential exposure of non-target organisms to CP4 EPSPS presents no conceivable mechanism to cause adverse effects because of its properties.
- Any occupational health aspect of handling NK603 maize is no different from traditional maize, and this maize was shown to be as safe and as nutritious as any other maize.
- The environmental impact of the cultivation, management and harvesting techniques applied in the planned trials is considered no different from the farming practices for traditional maize.


Brief description of any measures taken for the management of risks:
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 maize crop and that of its
receiving environment.
In case any adverse environmental effects, linked to the deliberate release of
NK603 maize, are observed during the period of release, these will be reported immediately to the Competent Authority.
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

Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
18/03/2014 00:00:00
Remarks: