W1 AM Nuts and Bolts of Logistics and Data Management for Data-Intensive Programs
Wednesday, 16 November 2005: 8:00 AM - 11:40 AM in Ballroom 1

(PAT-1117-034638) Data, Databases and QSARs within the European Union.

PATLEWICZ, G¹, NETZEVA, T¹, GALLEGOS, A¹, PAVAN, M¹, WORTH, A¹, ¹ European Chemicals Bureau, JRC, ISPRA, VARESE

ABSTRACT- In the context of current chemicals legislation within the European Union, the regulatory use of structure-activity relationships (SARs) and quantitative structure-activity relationships (QSARs), collectively referred to as (Q)SARs, has been limited. However, a legislative proposal for a new system for managing the risks of industrial chemicals is being debated at a political level. The new system, called REACH (Registration, Evaluation, and Authorisation of Chemicals), calls for equivalent information requirements to be applied to New and Existing Chemicals. Furthermore, for reasons of practicality, cost-effectiveness and animal welfare, it is envisaged that (Q)SARs and related approaches will play an important role in the assessment of approximately 30,000 existing chemicals for which further information is likely to be required under the REACH system. The European Commission′s Joint Research Centre (JRC) has a well-established role in providing independent scientific and technical advice to European policy makers. Within the JRC, policy support for the chemicals legislation is provided by the European Chemicals Bureau (ECB), which is also carrying out the scientific and technical work required for the eventual implementation of REACH. The ECB is also the focal point for the development, validation and implementation of (Q)SARs within the EU and in collaboration with OECD Member Countries. This presentation will describe the contribution of the ECB to the development and implementation of (Q)SARs, in terms of the models themselves, the depth of data underpinning them and a framework by which they can be effectively distributed for regulatory use.

Key words: (q)sars, REACH, databases