Risk characterisation of chemicals in food.

Information on hazard identification, hazard characterisation (including dose-response assessment) and exposure assessment are brought together under risk characterisation in order to provide advice to risk managers. Hazard identification and characterisation define the adverse effects produced by the chemical and are used to determine a health-based guidance value, such as an acceptable daily intake for threshold effects, or an estimate of the intake associated with a predefined level of risk for non-threshold effects. Exposure assessment aims to define average and high intakes, and has to take into account different dietary patterns. Hazard characterisation and exposure data need to be closely inter-related, for example the data should relate to the same life-stages and durations of exposure. Risk characterisation has to be an iterative process in which information on hazard and exposure are matched and any discrepancy taken into account where necessary by the generation of additional data. There is an established method of quantitative risk characterisation for non-threshold effects. A population distribution model is proposed that is applicable to estimate the risk associated with exposure to compounds producing threshold effects.

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