Pros and cons of hazard- versus risk-based approaches to food safety regulation

Legislation and regulations around the globe currently use a mixture of hazard- and risk-based approaches for ensuring the safety of food. This chapter focusses on the pros and cons of hazard- versus risk-based approaches to food safety regulation providing examples to illustrate the concepts and arguments provided. Hazard-based approaches only perform the first of the four steps that are part of risk assessment including hazard identification, hazard characterization, exposure assessment, and risk assessment. Hazard-based approaches are, for example, common practice in the field of allergenicity or genotoxicity, and also show a tendency to be increasingly applied as a result of the need for the replacement, reduction, and refinement (3Rs) of animal testing, resulting in use of a wide range of in vitro assays elucidating hazards but not risks. Recent developments, however, indicate a need for risk-based approaches even in the field of genotoxicity testing and allergenicity, while physiologically-based kinetic modeling is able to translate in vitro data to the in vivo situation enabling a risk rather than a hazard-based approach. Risk management and risk communication based on hazard assessment lead to unnecessary risk mitigation actions and consumer fear. Risk perception and the impact of globalization are key considerations for the future. It is concluded that future developments should be directed at moving away from hazard- toward risk-based evaluations and educating the risk assessors, risk managers, and the public on the fact that a hazard does not translate into a risk at certain levels of exposure, even for genotoxic carcinogens or allergens.