The key to successful Registration of substances under REACH lies in logical step-wise progression through the entire process. Most aspects of REACH are interlinked and the omission of a key aspect in the early stages could jeopardise a successful Registration.
wca has developed a 5-phase programme that covers the entire substance Registration process. While we are currently undertaking the full programme for a number of clients, one or more of the modules can be chosen individually, where a particular resource or expertise is needed by a client.
Phase I: Literature Review & Data Gap Analysis
Publicly available and client data are reviewed. The output from this phase is a data matrix which identifies endpoints where there are either no data, valid data exist, or other relevant toxicity data are available (e.g. QSAR and Read-Across). Where necessary, substance groups or categories can also be proposed.
Phase II: Test Programme Derogation
Relevant data from Phase I are scored for quality (Klimisch scores) and the data gap analysis is completed. The potential for test derogation and read-across between grouped substances is considered and reported in detail.
Phase III: Test Programme Design
A test programme is designed, based on derogations from Phase II, comprising the minimum number of tests to establish valid endpoint data. For substance categories we design a programme to maximise the read-across potential. We have the expertise to initiate and monitor the physico-chemical, toxicity, ecotoxicity and environmental studies in appropriate GLP-accredited Contract Research Organisations on behalf of a client.
Phase IV: Chemical Safety Assessment & Report
A Chemical Safety Report (CSR) detailing the results of a Chemical Safety Assessment (CSA) must be submitted with the Registration dossier for substances manufactured/imported above 10 tonnes per annum. Any CSA/CSR undertaken by wca complies with the format and content detailed in Annex 1 of the REACH regulations. It includes the relevant Exposure Scenarios developed for the use of the substance(s) together with the substance CLP/GHS classification.
Phase V: IUCLID File Compilation & Registration Dossiers
All submission to ECHA must be electronic, using the latest IUCLID file format. We populate the relevant sections of the file with the data either provided to us or generated during the course of the Phases III/IV. This also includes, where necessary, and proposals for further relevant testing. For Consortia in particular, we are able to host IUCLID files on our secure server for ease of access by member companies.