REACH (Registration, Evaluation and Authorisation of Chemicals)
RCL has the necessary level of expertise and is well placed to provide a range of services, either to individual companies or consortia, to ensure compliance with the requirements of REACH. These can include:
Pre-Registration Activities
- Representing non-European companies as their "only representative"
- Assistance with the preparation of chemical inventories
- Liaison with suppliers and downstream users
- Check chemical characteristics and identifiers of candidate substances
- Review potential for use of (Q)SARs or read-across
- Preparation of Pre-Registration submissions
Representation/Management
- Representation and project management for individual companies when members of SIEFs or consortia
- Consortium and SIEF management
- Agree use patterns and negotiation of access to existing data
- Establishment and maintenance of working relationships with the ECHA, the Competent Authorities, ECB and Commisssion
Registration Strategies
- Data gap analysis - assessment and validity of existing data from one or more sources
- Potential for use of waiver requests, (Q)SARs, read-across and public domain data
- Where new data are required, recommend options, source CROs and the monitoring of new studies
- Review classification and labelling of substances
- Development of data waivers
Document Development
- Preparation and submission of complete registration dossiers
- Preliminary and full risk assessments
- Preparation of IUCLID datasets
- Changes to Safety Data Sheets
- Searching databases
- Chemical Safety Reports and Chemical Safety Assessments
Post-Submission Monitoring
- Representation of individual companies and consortia at meetings with the regulatory authorities
- Monitoring progress of registration submissions
Where a substance is nominated for evaluation, RCL can provide the necessary support throughout the evaluation procedure.
Through close collaboration with a network of associates, RCL can provide specific toxicological analysis, preparation of consortium agreements and, where necessary, legal support.