Nordic Project on Information Strategies (NOIS) for Fulfilling Data Requirements under REACH

In 2004 the EU Commission initiated several REACH Implementation Projects (RIP) for development of technical guidance documents in support of the new EU Chemicals Legislation (REACH). The Nordic countries have worked on Information strategies in order to provide an early input to the RIP on information strategies that will prepare guidance documents to Industry regarding testing of chemicals. Guidance is needed on how the information should be generated, in a manner integrating different kinds of data by a weight of evidence approach (e.g., (Q)SAR, in vitro, in vivo data). The information strategies are stepwise procedures, where a higher level of data corresponds to more relevant, certain and accurate test data. The strategies should assist in deciding when sufficient data is available for the regulatory needs (e.g., classification and labelling, PBT-assessment, and risk assessment), considering the tonnage-based requirement set out by REACH. As the basis for elaboration of information strategies for selected environmental and human health end-points (to be published as part 2), some of the currently available testing and information requirements have been reviewed, e.g., the EU TGD, OECD guidance documents, and the REACH proposal. It has also been considered how data can be used for classification according to the GHS system. The analysis covers all environmental endpoints, and several human health endpoints. It is published in this report as part 1 of the Nordic project.