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Opinion of the Scientific Panel on genetically modified organisms [GMO] on an application (reference EFSA-GMO-NL-2004-02) for the placing on the market of insect-tolerant genetically modified maize 1507, for food use, under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International/Mycogen Seeds
No abstract available
This document provides an opinion of the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) on 1507 maize, genetically modified to provide protection against specific lepidopteran pests. The maize also contains a gene providing tolerance to the herbicide glufosinate.
In delivering its opinion the Panel considered the application, additional information provided by the applicant and comments submitted by the Member States. Further information from other applications for placing 1507 maize on the market under current regulatory procedures were taken into account where appropriate, as were comments from the Member States. The information from other applications were notification C/ES/01/01 for cultivation, import, processing and use as any other maize (excluding food uses) and notification C/NL/00/10 for import and processing. For regulatory reasons the latter applications resulted in separate opinions.
1507 maize was assessed with reference to its intended use employing the appropriate principles as 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 examination of the DNA inserted into 1507 maize and the nature and safety of the target proteins produced by the transgenic plants with respect to toxicology and allergenicity. Furthermore, a comparative analysis of agronomic traits and composition was undertaken and the safety of the whole food was evaluated. A nutritional and an environmental assessment, including monitoring plan, were both undertaken.
1507 maize has been developed for protection against specific lepidopteran pests such as the European corn borer (Ostrinia nubilalis) and Sesamia spp. and for tolerance to the herbicide glufosinate. Insect resistance is achieved by production of a truncated Cry1F protein from Bacillus thuringiensis ssp. aizawai and tolerance to the herbicide is conferred by a phosphinothricin-N-acetyltransferase (PAT) from Streptomyces viridochromogenes. Maize embryos were transformed by particle bombardment to transfer a DNA fragment containing these two genes. As a result of the genetic modification, the 1507 event contains an insert bearing both cry1F and pat genes, under the control of the maize ubiquitin and the 35S promoters, respectively.
Molecular analysis showed that 1507 maize contains one copy of the DNA fragment used for transformation and that this is present at a single locus in the nuclear genome of the GM plant. The complete DNA sequence of the insert was provided. In addition to the intact genes, the insert in 1507 maize includes DNA sequences originating from the fragment used for transformation as well as maize chloroplast and nuclear genome sequences at both ends of the inserted sequence. While these sequences may have resulted from the transformation process (insertional events), there were no indications that these additional fragments would result in the transcription of new RNA other than the mRNAs transcribed from the cry1F and pat genes. In the unlikely event that this does occur, bioinformatics analysis showed that any resulting peptides or proteins would have no homology to known toxins or allergens. Analysis of DNA sequences flanking both ends of the insert shows that they correspond to maize genomic DNA.
Analysis of kernel chemical composition from field trials in South America and Europe showed that 1507 maize was substantially equivalent to its non-GM comparator. Furthermore, appropriate animal feeding trials indicated that 1507 maize is nutritionally equivalent to its non-GM comparator.
Application EFSA-GMO-NL-2004-02 only concerns food uses for 1507 maize. Therefore, there is no requirement for scientific information on possible environmental effects associated with the cultivation of the GM maize. The GMO Panel agrees that unintended environmental effects due to the establishment and spread of GM maize will not be different from those of maize bred traditionally. The monitoring plan provided by the applicant is in line with the intended uses for the GMO.
In conclusion, the GMO Panel considers that the information available for 1507 maize addresses the outstanding questions raised by the Member States and considers that 1507 maize will not have an adverse effect on human and animal health or the environment in the context of its proposed use.
This scientific opinion corresponds to the risk assessment report requested under Article 6(6) of Regulation (EC) No 1829/2003 and will be part of the overall opinion as required by Regulation (EC) No 1829/2003.
GMO, maize, health, cultivation, environment, import, Regulation (EC) 258/97, Regulation (EC) 1829/2003, Directive 90/220/EEC, Directive 2001/18/EC. Zea mays, 1507, insect protection, Cry1F, PAT, food safety, human