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).