The Importance of Method Validation for Risk Assessment of Exposure to Chemicals in Foods

Abstract

Risk assessment of chemicals in foods is the scientific principle, which consists of 4 steps: 1) hazard identification, 2) hazard characterization, 3) exposure assessment and 4) risk characterization. Step 1 and 2 require toxicity data from animal or human studies, and require measurements of biochemical concentrations that indicate the body's response to chemical exposure. Then, method validation is required for measurement method. In the step 3, it is the step to acquire the amount of food consumption and concentration of a chemical of interest. The sources of concentration data may be derived from the allowance maximum levels of contaminants and food additives or from laboratory analysis of the chemical of interest. Nevertheless, whether the acquired concentration will be reliable, method validation is needed to be performed to provide an information related to the method characteristics and performances. Because in the risk assessment there is no zero risk, the limit of detection and limit of quantitation of test methods are considered for calculating an exposure to chemicals of interest. The benefits of method validation do not only provide the efficiency and reliability of the method itself but also provide benefit in protecting consumer health.