1 Division of Toxicology and Risk Assessment, National Food Institute, Technical University of Denmark2 National Food Institute, Technical University of Denmark3 Technical University of Denmark4 unknown
Background This project proposal deals with the development of a sensitive and specific animal test which is necessary for safety analysis of genetically modified plants according to the Opinion of the Scientific Committee for Food on the assessment of novels foods. The test will be based on the OECD 90 day rodent study supplemented with sensitive and specific markers for potential toxicity of the products encode by the inserted genes in the tested food item, the use of a semisynthetic diet with interchangeable constituents and the extensive use of initial chemical and in-vitro testing for guiding the precise design of the animal study. The genetically modified food plants to be used for this test development will be 3 transgenic rice varieties (2 types of lectins and the Bt toxin). Objectives The overall objective of this project is to develop and validate the scientific methodology which is necessary for assessing the safety of foods from genetically modified plants in accordance with the EU Regulation 258/97 of 27 January 1997 concerning novel foods and novel food ingredients. The project is designed to meet the urgent need for a sensitive and specific testing strategy for GM foods in a scientifically valid and economically feasible manner. The specific objectives are to: improve the sensitivity and specificity of standard OECD guideline toxicity tests towards detection of specific chemical entities in the GM food matrix by the measurement of additional biological endpoints based on prior knowledge. improve the quality of this prior knowledge through precise information regarding the gene construct, its site of insertion and the chemical and toxicological characteristics of the gene product based upon chemical analytical studies and short term in vivo and in vitro studies. improve the quality of this prior knowledge through precise information regarding unintended secondary changes in the GM food item, which may alter the nutritional-toxicological properties of that food. (expected) Results and achievements The results of the project will be evaluated at a final workshop and the recommendations will be used to guide future test requirement for the safety assessment of genetically modified food plant within EU and worldwide.