Preparation of Technical Dossiers
The team of REACh ChemConsult GmbH prepares the technical dossiers for any potential registrants (manufacturer, importer, only representative, lead registrant, consortia). The technical dossier comprises the data as set out in Art. 10 of REACH. Data on intrinsic properties are needed according to the standard data requirements of Annex VII to XI of REACH. Our experts in the field of toxicology, ecotoxicology and (environmental) chemistry validate data on intrinsic properties and insert the data into the IUCLID 5 registration dossier. This comprises the following steps:
- Preparation of datasets as robust study summaries / study summaries from available studies (own studies or with Letter of access) or from publicly available data on:
- physicochemical properties
- environmental fate
- toxicity
- ecotoxicity - Data verification and classification of the studies reliability according to Klimisch et al. (1997)
- Validation of migrated IUCLID 4 datasets, and if necessary validation according to the original study report
- Determination of key studies for risk assessment
- Justification of Data waiving by expert judgement
- Preparation of Endpoint Study Summaries for each endpoint
- After data gap analysis different strategies comprising waiving, read across or performing of tests will be supposed to meet the standard information requirements
- Propose a qualified testing strategy that must be submitted to the ECHA (for substances of Ann. IX if >100 t/y, X if >1000 t/y)
If the yearly volume exceeds 10 t the chemical safety report (CSR) including the chemicals safety assessment (CSA) will be prepared. [See information on CSR Service]
For a quotation on our competent service on the preparation of Registration dossier please contact us.