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 trials continuation under official supervision with genetically modified maize tolerant to glyphosate, derived from NK603, for variety registration.

Proposed period of release:
01/02/2012 to 28/02/2012

Name of the Institute(s) or Company(ies)
Monsanto Europe, S.A., represented by Monsanto Agricultura España, S.L., ;

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

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

If yes, notification number(s):
B/CZ/06/04; B/DE/00/115; B/DE/03/148; B/DE/06/185; B/DK/07/01; B/DK/07/02; B/DK/07/03; B/DK/07/04; B/DK/08/01; 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/08/09; B/ES/09/04; B/ES/09/12; B/ES/09/19; B/ES/10/04; B/ES/10/09; B/ES/11/05; B/ES/11/07; B/FR/00/03/05; B/FR/01/01/01; B/FR/04/02/02; B/FR/06/01/01; B/FR/99/04/06; B/IT/99/17; B/PT/09/01; B/PT/10/01; B/RO/08/09; B/RO/09/07; B/RO/09/19; B/RO/10/03; B/SE/05/9831; B/SK/06/01; B/SK/08/03;

Other notifications
2-01/2007 (PL)
IM-07-008 (NL)
82/2008 (PL) (HU)
02-06/2006 (PL)
02-1/2009 (PL)

C/ES/00/01 and C/ES/03/01 Notifications according to Dir 2001/18/EC and EFSA-GMO-NL-2005-22 according to Regulation (EC) 1829/2003 on Genetically Modified Food and Feed.
In addition, many field trials have already been conducted across maize growing in several world areas. NK603 maize has been commercially released for cultivation in the U.S.A. And Canada, since 2001, in Argentina since 2004, in Brazil, other countries in the Americas (Colombia, Honduras), Asia (China, the Philippines) and Africa (South Africa) since 2009. NK603 has also been approved for import in the EU, Russia, Australia, Japan, Taiwan, New Zealand, Mexico, Korea, Singapore and Malaysia.

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysNK603 maize

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
NK603 maize expresses CP4 EPSPS proteins, which impart tolerance to glyphosate (N phosphonomethyl-glycine), the active ingredient in the non-selective herbicide Roundup. EPSPS is an enzyme involved in the shikimic acid pathway for aromatic amino acid biosynthesis in plants and microorganisms. CP4 EPSPS enzymes have been shown to have significantly reduced affinity for glyphosate herbicide 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:

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
Components of the inserted DNA fragment inherited from NK603 maize:

Genetic Element: Source. Size (kb). Function.

First cp4 epsps gene cassette

- P-ract1/ ract1 intron: Oryza sativa. 1.4kb. Contains promoter, transcription start site and first intron.

- Ctp 2: Arabidopsis thaliana. 0.2kb. Encodes chloroplast transit peptide, which directs the CP4 EPSPS protein to the chloroplast.

- cp4 epsps: Agrobacterium sp. strain CP4. 1.4kb. Encodes glyphosate-tolerant CP4 EPSPS protein.

- NOS 3’: Agrobacterium tumefaciens. 0.3kb. Ends transcription and directs polyadenylation of the mRNA.

Second cp4 epsps gene cassette

- e35S: Cauliflower mosaic virus. 0.6kb. Promoter.

- Zmhsp70: Zea mays L. 0.8kb. Stabilizes the level of gene transcription.

- Ctp 2: Arabidopsis thaliana. 0.2kb. Encodes chloroplast transit peptide, which directs the CP4 EPSPS protein to the chloroplast.

- cp4 epsps l214p: Agrobacterium sp. strain CP4. 1.4kb. Encodes glyphosate-tolerant CP4 EPSPS L214P protein*.

- NOS 3’: Agrobacterium tumefaciens. 0.3kb. Ends transcription and directs polyadenylation of the mRNA.

*The substitution of leucine by proline in the CP4 EPSPS encoded by the second cp4 epsps gene in the NK603 insert is indicated by the suffix L214P.

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:
The release of genetically modified maize derived from transformation event NK603, which confers tolerance to glyphosate, has the aim to collect regulatory data (DUS and Agronomic Value).

2. Geographical location of the site:
The selected sites are located in the following localities:
- Fuente Palmera (Córdoba)
- Dos Hermanas (Sevilla)
- Lebrija (Sevilla)
- Grañén (Huesca)
- Ejea de los Caballeros (Zaragoza)
- Daimiel (Ciudad Real)
- Calera y Chozas (Toledo)
- Alcarrás (Lleida)
- Valdetorres (Badajoz)

3. Size of the site (m2):
The potential surface occupied in every site by NK603 maize will be:
- Fuente Palmera (Córdoba): 2.500 m²
- Dos Hermanas (Sevilla): 2.500 m²
- Lebrija (Sevilla): 2.500 m²
- Grañén (Huesca): 2.500 m²
- Ejea de los Caballeros (Zaragoza): 2.500 m²
- Daimiel (Ciudad Real): 2.500 m²
- Calera y Chozas (Toledo): 2.500 m²
- Alcarrás (Lleida): 2.500 m²
- Valdetorres (Badajoz): 2.500 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:
Post-release general surveillance from environments inside and outside the EU has shown that NK603 behavior is similar to the conventional corn so it is unlikely to 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:
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.

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.

It is actually expected that the commercial production of NK603 maize 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 risk of this maize is no different from conventional maize and the favorable scientific opinion adopted by EFSA concluded that NK603 is as safe as its conventional counterpart with respect to potential direct effects on human and animal health and the environment. Therefore, strategies for risk management for NK603 maize would be the same as for traditional maize.

In addition to the scheduled observations of phenotypic and 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 environmental effects. This will be done by visual inspection of the status of the NK603 crop and that of its receiving environment. In case of any adverse environmental effects linked to the deliberate release of NK603, observed during the period of release, these will be reported immediately to the Competent Authority.

The spatial isolation distance (200 m) from other maize crops and the four rows of non transgenic maize surrounding the trials will prevent the risk of hybridization with other maize plants.

Seeds will be transported in sealed and labeled bags, and their management for setting the trial will be done by qualified staff, informed about preventive measures to avoid any spill. The equipments, especially the experimental drill and combine, will be cleaned on the experimental site, thus preventing seed dissemination.

Plant products from trials will be only used for studies intended by this notification and will be destroyed at their end. After completion of harvest, the stalks will be chopped and then incorporated into the soil. Harvested grain not used in further analysis or studies will be destroyed by burying.

Although regrowth in the rotation crops is unlikely because of poor winter survival, the site will be sown either with a crop different from maize or with experimental maize that will be destroyed and not used in any commercial, industrial or food application. Volunteer plants will be controlled by mechanical destruction or other non-selective herbicides.

At the end of the field-testing campaign, a report 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.

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:
20/04/2012 00:00:00