Human dietary exposure assessment to newly expressed proteins in GM foods

EFSA carries out the risk assessment of genetically modified organisms (GMOs) submitted under Regulation (EC) 1829/2003 and Regulation (EU) 503/2013. Dietary exposure is an essential element of the risk assessment on genetically modified (GM) foods. Dietary exposure estimations should cover average and high consumers across all the different age classes and special population groups and identify and consider particular consumer groups with expected higher exposure. This EFSA statement provides guidance on how human dietary exposure to newly expressed proteins in GM foods should be estimated using a deterministic model that makes use of the available information. Summary statistics of consumption of foods containing, consisting of and produced from crops relevant for the assessment of GMO applications are available in the EFSA website together with different factors to convert the reported consumption of processed foods into raw primary commodities. Guidance is also provided on how concentration data of newly expressed proteins, typically determined in raw primary commodities, should be used (materials to be analysed, growth stage, descriptive statistics to be used, etc.). An overview of the different uncertainties linked to the dietary exposure estimations is provided, informing on the strengths and limitations of the assessment. The document also describes the information applicants need to provide on human dietary exposure to allow EFSA doing an appropriate evaluation of the assessment provided as part of the application dossiers.