DEFINITION
The risk characterisation evaluates whether the estimated exposure remains below the derived values considered safe (e.g. DNEL/PNEC) and whether risks are thus adequately controlled. It is a core component of the CSA and CSR.
DeclarationRisk Characterisation
Results are documented as quotients or qualitative statements and direct the selection of risk management measures. In the event of exceedances, conditions of use must be adjusted, measures tightened, or alternatives evaluated.
In practice: Ensure transparent calculations, uncertainty analyses, and a clear derivation of measures. Link the results to exposure scenarios and reflect adjustments in the SDS in a timely manner.
Key Points
- Comparison of exposure and derived limit values.
- Completion of the CSA under REACH.
- Documentation in the CSR required.
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