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Opinion of the Scientific Panel on genetically modified organisms [GMO] on an application (Reference EFSA-GMO-UK-2004-05) for the placing on the market of insect-protected and glufosinate and glyphosate-tolerant genetically modified maize 1507 x NK603, for food and feed uses, and import and processing under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred and Mycogen Seeds
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This document provides an opinion of the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) on genetically modified maize 1507 x NK603 (Unique Identifier DAS?Ø15Ø7?1 x MON?ØØ6Ø3?6) developed to provide protection against specific lepidopteran pests and tolerance to the herbicides glufosinate and glyphosate.
In delivering its opinion the Panel considered the application EFSA-GMO-UK-2004-05, additional information provided by the applicant and the scientific comments submitted by the Member States. Further information from applications for placing the single events maize 1507 and maize NK603 on the market under EU regulatory procedures was taken into account, when appropriate.
The GMO Panel assessed 1507 x NK603 maize with reference to the intended uses and the appropriate principles described in the guidance document of the Scientific Panel on Genetically Modified Organisms for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed. The scientific assessment included molecular characterisation of the inserted DNA and expression of target proteins. A comparative analysis of agronomic traits and composition was undertaken and the safety of the new proteins and the whole food/feed was evaluated with respect to toxicity and allergenicity. Both a nutritional and an environmental assessment were undertaken, the latter including an environmental monitoring plan.
The single events maize 1507 and NK603 have been the subjects of earlier assessments. Maize 1507 was developed to be tolerant to the herbicide glufosinate by the introduction of a gene encoding phosphinothricin?N?acetyltransferase (PAT) from Streptomyces viridochromogenes and to provide protection against certain lepidopteran pests such as the European corn borer (Ostrinia nubilalis) and species belonging to the genus Sesamia by the introduction of a truncated cry1F gene from Bacillus thuringiensis ssp. aizawai. Maize 1507 was assessed previously for import and processing under Part C of Directive 2001/18/EC. It was also assessed for import, feed and industrial processing and cultivation, under Part C of Directive 2001/18/EC and for food use, under Regulation (EC) No 1829/2003. It was approved for import, processing and feed uses under Directive 2001/18 by Commission Decision 2005/772/EC and for food uses under Regulation 1829/2003 by Commission Decision 2006/197/EC. NK603 was developed to be tolerant to the herbicide glyphosate by the introduction of a gene coding for 5?enolpyruvylshikimate?3?phosphate synthase from Agrobacterium sp. strain CP4 (CP4 EPSPS). NK603 has received EFSA opinions in favour of its authorisation and was authorised under Directive 2001/18/EC by Commission Decision 2004/643/EC. The use of food and food ingredients from NK603 maize was authorised under Regulation (EC) No 258/97 by Commission Decision 2005/448/EC.
Maize 1507 x NK603 is produced by crosses between maize inbred lines containing maize events 1507 and NK603 to combine the lepidopteran resistance trait and glufosinate tolerance in maize 1507 with glyphosate tolerance in maize NK603. No new genetic modifications were introduced.
Molecular analysis of the DNA inserts present in maize 1507 x NK603 confirmed that both maize event 1507 and maize event NK603 are present and the structure of their inserts is retained.
Cry1F and CP4 EPSPS protein levels in kernels of maize 1507 x NK603 were comparable with the levels in the parental maize lines 1507 and NK603, previously assessed. PAT was expressed below the lower limit of quantification of the assay both in kernels of maize 1507 and in kernels of maize 1507 x NK603. The safety of the Cry1F, PAT and CP4 EPSPS proteins has previously been assessed and positive opinions on the single 1507 and NK603 maize events have been given by EFSA. The Panel found no evidence of any interactions between the newly expressed Cry1F, PAT and CP4 EPSPS proteins.
Maize 1507 x NK603 contains transgenic proteins resulting in an insect? resistant and herbicide? tolerant phenotype. Besides these deliberate changes, this maize neither showed marked alterations in composition, agronomy and phenotype compared with a non-GM hybrid maize with a genetic background similar to the maize 1507 x NK603, nor with several non-GM reference lines. The Panel therefore concludes that except for the introduced traits, maize 1507 x NK603 is compositionally and phenotypically equivalent to conventional counterparts.
A feeding study conducted with maize 1507 x NK603 on broilers confirmed the nutritional wholesomeness. The Panel considers that the nutritional properties of this maize would be no different from those of conventional counterparts.
The application EFSA?GMO?UK?2004?05 concerns food and feed uses, import and processing. There is therefore no requirement for scientific information on possible environmental effects associated with the cultivation of the maize lines. The GMO Panel agrees that unintended environmental effects due to the establishment and spread of GM maize will not be different from that of conventionally bred maize. The monitoring plan provided by the applicant is in line with the intended uses for the GMO.
In conclusion, the Panel considers that the information available for maize 1507 x NK603 addresses the scientific comments raised by the Member States and that the GM maize 1507 x NK603 is as safe as its conventional counterparts with respect to effects on human and animal health and the environment. Therefore the Panel concludes that this maize is unlikely to have any adverse effect on human and animal health and the environment in the context of its intended uses.
GMOs, maize, 1507, NK603, 1507 x NK603, insect protection, DAS-Ø15Ø7-1 x MON-ØØ6Ø3-6, gluphosinate tolerance, glyphosate tolerance, Cry1F, PAT, CP4 EPSPS, food/feed safety, human health, environment, import, Regulation (EC) No 258/97, Directive 2001/18/EC, Regulation (EC) No 1829/2003