Scientific risk assessments are evidence based and consider both hazard and consumer exposure in assessing whether there may be unacceptable risks to health. Safety factors are typically applied to extrapolate the hazards to humans once they are identified.
For nutritional constituents of the diet, additional risk assessment approaches such as substantial equivalence, weighing risk-benefit and history of safe use can be considered.
The diversity of questions now being asked in food safety (e.g., combined exposures, process intermediates, environmental degradates), together with rapid advances in scientific knowledge and challenges to the reliability of animal testing, is resulting in a paradigm shift in toxicology where new approaches involving MIE (molecular initiating events) and AOPs (adverse outcome pathways) are being developed. The challenge is for these new approaches to be robust enough to assure product safety and for them to be accepted by regulatory agencies.