Insect-resistant and herbicide-tolerant maize (1507)

Two companies, Pioneer Hi-Bred and Mycogen Seeds, jointly presented a safety dossier for the genetically modified maize line 1507. This dossier contains molecular biological, nutritional and toxicological information. The reference is a conventional maize line with a history of safe use within the European Union. The modified maize line differs from a conventional line, due to the presence of the cry1F and pat genes and their expression products, the CRY1F and PAT proteins. The inserted genes, which are of bacterial origin, have been modified for optimal expression in the plant. This renders the maize plant resistant to damage by certain insect pests and tolerant to treatment with the herbicide glufosinate ammonium in the field. Molecular biological analysis of the new crop revealed that a single, complete copy of each of these genes is present at a single location in the DNA of 1507 maize. There are no indications that the new proteins are toxic or allergenic for humans in the concentrations at which they occur. The intended change is associated with unintended rearrangements of the DNA flanking the insertion, which have also been analysed in detail. There are no indications that the changes in the maize plant genome result in the unintended production of other new proteins. The modified maize line’s composition has been compared with that of a near isogenic, non-modified maize line by means of a chemical analysis of a large number of components: micronutrients, macronutrients, antinutrients and secondary metabolites. To this end, field trials were conducted at several locations, the results of which were processed for each location separately. Observed variations in the components investigated remained within the figures cited in the references and have no health-related consequences. Furthermore, in a subchronic toxicity study on animals, no adverse effects of the modification in 1507 maize were observed. The Committee is of the opinion that the information in the dossier provides sufficient basis for a safety assessment. The dossier contains a correct interpretation of the data submitted. Based on current scientific knowledge, the Committee’s opinion is that the consumption of 1507 maize, as well as foods and food ingredients derived from this, is just as safe for humans as the consumption of non-genetically modified maize and maize products.

Committee

• Prof. dr LM Schoonhoven, emeritus professor of entomology; Wageningen University and Research centre, chairman
• Prof. dr CAFM Bruijnzeel-Koomen, professor of dermatology/allergology; Academic Hospital Utrecht
• Ir EJ Kok, toxicologist; National Institute for Quality Control of Agricultural Products, Wageningen
• Dr CF van Kreijl, molecular biologist; National Institute of Public Health and the Environment, Bilthoven
• Prof. dr P van der Laan, professor of statistics; Technical University Eindhoven
• Dr FM Nagengast, gastro enterologist; Academic Hospital Nijmegen
• Dr ir JMA van Raaij, food physiologist; Wageningen University and Research centre
• Prof. dr ir G Schaafsma, professor of nutrition; TNO Nutrition and Food Research, Zeist
• Prof. dr EG Schouten, professor of epidemiology; Wageningen University and Research centre
• Dr GJA Speijers, toxicologist; National Institute of Public Health and the Environment, Bilthoven
• Prof. Dr WJ Stiekema, professor of bioinformatics; Wageningen University and Research centre
• Ir R Top, Ministry of Health, Welfare and Sport; The Hague, advisor
• Prof. dr WM de Vos, professor of microbiology; Wageningen University and Research centre
• Dr ir F van der Wilk, Committee on Genetic Modification, Bilthoven, advisor
• Dr RA Woutersen, toxicologist; TNO Nutrition and Food Research, Zeist
• Dr CMA van Rossum, Health Council of the Netherlands, The Hague, scientific staff member