Health Risk Assessment
The EHC monographs are intended to provide critical reviews on the effect on human health and the environment of physical, chemical and biological agents. As such, they include and review studies that are of direct relevance for the evaluation. However, they do not describe every study that has been carried out. Worldwide data are used and are quoted from original studies, not from abstracts or reviews. Both published and unpublished reports are considered, but preference is always given to published data. Unpublished data are only used when relevant published data are absent or when the unpublished data are pivotal to the risk assessment. A detailed policy statement is available that describes the procedures used for unpublished proprietary data so that this information can be used in the evaluation without compromising its confidential nature.
In the evaluation of human health risks, sound human data, whenever available, are generally more informative than animal data. Animal and in vitro studies provide support and are used mainly to supply evidence that is missing from human studies. It is mandatory that research on human subjects be conducted in full accord with ethical principles, including the provisions of the Helsinki Declaration.
All studies, with either positive or negative effects, need to be evaluated and judged on their own merit, and then collectively evaluated and judged in a weight of evidence approach. It is important to determine how much a set of evidence changes the probability that exposure causes an outcome. Generally, studies must be replicated or be in agreement with similar studies. The evidence for an effect is further strengthened if the results from different types of studies (epidemiology or laboratory) point to the same conclusion.
The EHC monographs are intended to assist national and international authorities in making risk assessments and subsequent risk management decisions. They represent a thorough evaluation of risks and are not, in any sense, recommendations for regulation or standard setting. These latter are the exclusive purview of national and regional governments.