a. Statements of Principle relating to the Role of Food Safety Risk Assessment
Health and safety aspects of Codex decisions and recommendations should be based on a risk assessment, as appropriate to the circumstances.
Food safety risk assessment should be soundly based on science, should incorporate the four steps of the risk assessment process, and should be documented in a transparent manner.
There should be a functional separation of risk assessment and risk management, while recognizing that some interactions are essential for a pragmatic approach.
Risk assessments should use available quantitative information to the greatest extent possible and risk characterizations should be presented in a readily understandable and useful form.
b. Definitions of Risk Analysis Terms related to Food Safety14
HAZARD: A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.
RISK: A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.
RISK ANALYSIS: A process consisting of three components: risk assessment, risk management and risk communication.
RISK ASSESSMENT: A scientifically based process consisting of the following steps : (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization.
HAZARD IDENTIFICATION: The identification of biological, chemical, and physical agents capable of causing adverse health effects and which may be present in a particular food or group of foods.
HAZARD CHARACTERIZATION: The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food. For chemical agents, a dose-response assessment should be performed. For biological or physical agents, a dose-response assessment should be performed if the data are obtainable.
DOSE-RESPONSE ASSESSMENT: The determination of the relationship between the magnitude of exposure (dose) to a chemical, biological or physical agent and the severity and/or frequency of associated adverse health effects (response).
EXPOSURE ASSESSMENT: The qualitative and/or quantitative evaluation of the likely intake of biological, chemical, and physical agents via food as well as exposures from other sources if relevant.
RISK CHARACTERIZATION: The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment.
RISK MANAGEMENT: The process of weighing policy alternatives in the light of the results of risk assessment and, if required, selecting and implementing appropriate control options, including regulatory measures.
RISK COMMUNICATION: The interactive exchange of information and opinions concerning risk among risk assessors, risk managers, consumers and other interested parties.
