The overall objective of this project is to develop and validate the scientific methodology, which is necessary for quantitative risk assessment of second generation of novel foods to be marketed in EU. The project is designed to address both the risk assessment (including hazard identification, hazard characterization, exposure assessment and risk characterization) and the risk/benefit equation. The project addresses the scientific challenge of developing state of the art approaches to assess the safety, nutritional adequacy and efficacy of novel foods in a comprehensive and interlinked set of studies. The novel approaches deployed will be tested on three model examples which are either already on, or may be introduced to, the market. The models selected are (i) genetically modified (GM) and conventionally bred potato tubers with altered content and balance of inherent toxicants (glycoalkaloids), (ii) a conventionally bred rice mutated line low in an anti-nutritional constituent (phytic acid), and (iii) functional food ingredients of natural origin (phytosterol and phytostanol esters). The proposed methodology takes us beyond the current state of the art since it aims at: Deploying precise genomic and non-targeted profiling approaches for comprehensive characterisation of the novel foods as the primary basis for subsequent in-vitro and in-vivo studies Performing sensitive in-vitro studies supported by profiling approaches to identify early biomarkers of toxicity and efficacy as additional tools for designing tailored in-vivo studies Introducing a de-minimis diet for sensitive in-vivo studies, supported by profiling approaches and addressing safety, nutritional adequacy, and efficacy in a common approach Conducting exposure assessment by innovative probabilistic techniques based on recipe databases on tailored software code Combining the outcomes of hazard/efficacy assessment, exposure assessment in a risk-benefit analysis Taking into account whether the risk/benefit evaluation carried out will sufficiently address the problems with the respective foods as understood by the general public Summarising the results of the project in an appropriate form for subsequent communication to the wider stakeholder audience The project is coordinated by the National Food Institute, Division of Toxicology and Risk Assessment.
|Period||01/01/04 → 31/03/07|