Abstract

In this paper it is claimed that the health risk assessment process is influenced by (at least) four general factors, namely: the regulatory framework, the quality and availability of scientific data, general risk assessment principles, and case-by-case assumptions. Furthermore, the scientific basis of risk assessment relies on three overall types of methods for data generation: standardized animal experiments, epidemiology, and non-standardized mechanism data. In this paper, the use of the different types of data for risk assessment purposes are analyzed in the light of the factors claimed to influence the risk assessment process. It is concluded that the availability of pre-defined criteria for the interpretation and evaluation of data for regulatory health risk assessment purposes need to be further developed. Especially with the implementation of the new European chemicals legislation REACH.

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