The OSIRIS Project

The new regulation concerning the registration, evaluation, authorisation and restriction of chemicals (REACH) requires demonstration of the safe manufacture of chemicals and their safe use throughout the supply chain.
While REACH is based on the precautionary principle, it includes also the aim to reduce animal testing where possible.

The goal of the project OSIRIS is to develop integrated testing strategies (ITS) fit for REACH that enable to significantly increase the use of non-testing information for regulatory decision making, and thus to minimise the need for animal testing. To this end, operational procedures are developed, tested and disseminated that guide a transparent and scientifically sound evaluation of chemical substances in a risk-driven, context-specific and substance-tailored manner.

The envisaged decision theory framework includes alternative methods such as chemical and biological read-across, in vitro results, in vivo information on analogues, qualitative and quantitative structure-activity relationships, thresholds of toxicological concern and exposure-based waiving. OSIRIS takes into account cost-benefit analyses, and it aims to close the gap between risk and societal risk perception. It is based on the new REACH paradigm to move away from extensive standard testing to a more intelligent, substance-tailored approach.

The work is organised in the five interlinked research Pillars

- Chemical Domain,
- Biological Domain,
- Exposure,
- Integration Strategies and Tools,
- Case Studies,

with a particular focus on more complex, long-term and high-cost endpoints. Case studies will demonstrate the feasibility and effectiveness of the new ITS methodologies, and provide guidance in concrete form.

To ensure optimal uptake of the results obtained in this project, end-users in industry and regulatory authorities are closely involved in monitoring and in providing specific technical contributions to this project.