Food additives risk characterization

The degree of confidence in the final estimation of risk depends on variability, uncertainty, and assumptions identified in all previous steps. The nature of the information available for risk characterization and the associated uncertainties can vary widely, and no single approach is suitable for all hazard and exposure scenarios. In cases in which risk characterization is concluded before human exposure occurs, for example, with food additives that require prior approval, both hazard identification and hazard characterization are largely dependent on animal experiments. And exposure is a theoretical estimate based on predicted uses or residue levels. In contrast, in cases of prior human exposure, hazard identification and hazard characterization may be based on studies in humans and exposure assessment can be based on real-life, actual intake measurements. The influence of estimates and assumptions can be evaluated by using sensitivity and uncertainty analyses. - Risk assessment procedures differ in a range of possible options from relatively unso-... 

Hazard assessment and exposure assessment of chemicals are generally common stages performed similarly independent of the chemical use category (industrial chemical, pesticide, biocide, food additive, food contact material, etc.). However, variation occurs in the way in which the exposure assessment and hazard assessment information are integrated in the risk characterization step, depending on the regulation involved and the goal of the risk assessment. This wdl be addressed in more detail in the next section. 

In addition, current Food and Drug Administration (FDA) guidelines outline a series of short-term and in vitro tests for the safety assessment of bound residues together with their chemical characterization (5). A study of reversibility of adduct formation is also included and as with the Joint FAO/WHO Expert Committee on Food Additives (JECFA) recommendation, drugs are investigated in an individual manner. It seems likely that the JECFA and FDA approaches, at least in general terms, will become widely adopted in this particular area of hazard and risk assessment. 

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