Methodological Approaches for Risk Assessment of Tobacco and Related Products.

Health risk assessment of tobacco and related products (TRPs) is highly challenging due to the variety in products, even within the product class, the complex mixture of components in the emission and the variety of user behaviour. In this paper, we summarize methods that can be used to assess the health risks associated with the use of TRPs. The choice of methods to be used and the data needed are dependent on the aim. Risk assessment can be used to identify the emission components of highest health concern. Alternatively, risk assessment methods can be used to determine the absolute risk of a TRP, which is the health risk of a product, not related to other products, or to determine the relative risk of a TRP, which is the health risk of a TRP compared to, for example, a cigarette. Generally, health risk assessment can be based on the effects of the complete mixture (whole smoke) or based on the (added) effects of individual components. Data requirements are dependent on the method used, but most methods require substantial data on identity and quantity of components in emissions and on the hazards of these components. Especially for hazards, only limited data are available. Currently, due to a lack of suitable data, quantitative risk assessment methods cannot be used to inform regulation.