Preparation of the Chemical Safety Report (CSR, if > 10 t/y)
REACh ChemConsult GmbH prepares the technical dossiers. If the yearly volume exceeds 10 t the chemical safety report (CSR) including the chemicals safety assessment (CSA) will be prepared. The chemical safety report is part of the submission dossier created in IUCLID 5 software. If a substance fulfils criteria according to Art. 14 (4) the chemical safety assessment shall include the exposure assessment and risk assessment. Within the CSR the following steps will be performed by our expert team.
- Hazard assessment
"Hazard assessment" comprises the following:
- The „predicted no effect concentrations“ (PNECs) are estimated for each relevant environmental compartment. This service includes a detailed rationale.
- The "derived no effect levels" (DNELs) are estimated for human (workers, consumer, man via environment) including a detailed rationale.
- Classification and labelling of substances
- Exposure assessment:
The exposure assessment comprises the following services (for dangerous and PBT or vPvB substances):
- exposure assessment including the generation of exposure scenario(s) (or the identification of relevant use and exposure categories if appropriate), which includes
- exposure estimation for each relevant exposure scenario using appropriate tools for exposure estimation and/or exposure monitoring
- Risk characterisation:
The outcome of a risk characterisation within the chemical safety assessment is fundamentally dependent on the intrinsic properties of the substance and the exposure levels for its use. We carry out the risk characterisation within the CSA. Integrated test strategies will be used in case risks are not adequately controlled according to the 1st CSA. This tiered approach comprises either more testing in order to reduce uncertainty (and thus applying lower uncertainty factors), or more precisely exposure estimation using more specified estimation models and/ or application of further risk reduction measures (RMM).
For a quotation on our competent Chemical Safety Assessment service please contact us.