Data-Gap Analysis for REACH
One of the first steps in preparing a registration dossier is to determine what information is available in order to meet the data requirements set out in Annexes VII to X of REACH.
ReFaC can help potential registrants to collate and evaluate the available data and determine where (if any) data gaps may lie and propose a strategy to fulfil such gaps.
Typically ReFaC would perform the following tasks as part of this process:
- Literature search; including preparation of a detailed report and identification of key data for further review
- Data acquisition
- Evaluation of key data in terms of adequacy and reliability for REACH
- Preparation of report detailing recommendations for testing (where applicable to fill a data gap) or recommendations’ for data adaptations (data waiving).
In addition, ReFaC can organise for the data to be generated by testing (see Testing Services) or by using computational Quantitative Structure-Activity Relationship Q(SAR) models of the substance in order predict the (eco)toxicological properties without the need for testing.
For further information or for a quotation tailored to your needs; contact ReFaC now.
