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.
The project will examine a two step safety testing procedure for GM plant food, having chemical analysis and short term in vivo and in vitro testing in the first step and the core 90 day rat study in the second step. The test design will be evaluated through the testing of 3 transgenic rice varieties (gene inserts: GNA lectin, PHA-E lectin, Bt-toxin) measured against the testing of spiked rice. The test design and the results obtained through the proposed study will be evaluated at a workshop and recommendations for the future testing procedures to be applied to GM plant food for the European market will be given. The results from these studies will be published in the scientific literature, and conclusions and recommendations will be made available to the general public.
Creation of scientific evidence to match the demands from consumers regarding scientific data of good quality in support or denial of claims regarding safe and nutritious foods for the European consumer.
Creation of scientific support for the importers in their choices for safe and wholesome novel food plants from outside EU for the European consumer.
Formulation of a combined nutritional-toxicological basis for the introduction of a variety of safe and wholesome foods necessary to meet increasing demands for high quality foods beyond year 2000.
Formulation of scientific advice to guiding the improvement of traditional food plants in a safe and wholesome manner by modern agricultural biotechnology.
Improving possibilities for the food industry to develop safe and wholesome novel and unique food products.
Reducing the cost for product development by the introduction of wide range short-term safety testing methods leading to the use of fewer tests each addressing more endpoints.
Formulation of the scientific background for updating regulations issued by national governments and the EU Commission on safety assessments of novel food and novel food ingredients.