ABSTRACT
Legislation on the control of chemicals requires assessment of their inherent
properties in order to predict risks for human health and the environment. In the
European Union (EU), chemicals legislation is based on the “Dangerous Substances
Directive” of 1967 (Directive 67/548/EEC) and its subsequent amendments (1).
While legislative requirements for hazard assessment are clear, efforts to harmonize
ideas between industry and the member states with respect to risk assessment have
been slow for some end points. Therefore, in the EU, these initiatives are described
in the White Paper on a Strategy for a Future Chemicals Policy as a framework for the
Registration, Evaluation, and Authorization of Chemicals (REACH) (2). This new
EU policy underlines the needs for the development of valid in vitro and
(quantitative) structure-activity relationship [(Q)SAR] models for toxicological
assessment of all untested chemicals that are already on the market. This policy
makes use of all available information on a chemical prior to any considerations on
further testing, especially prior to any in vivo testing. The REACH text has now
been outlined (3).