Chemical Safety Assessment (CSA)
Last updated:
05 December 2025
•
3 min read
DEFINITION
The Chemical Safety Assessment (CSA) is a central requirement of the REACH Regulation for the systematic evaluation of health and environmental risks associated with chemical substances. It comprises hazard assessment, exposure assessment, the derivation of DNEL (Derived No-Effect Level) and PNEC (Predicted No-Effect Concentration), and the final risk characterisation for human health and the environment.
DeclarationChemical Safety Assessment (CSA)
The chemical safety assessment (CSA) forms the scientific basis for the Chemical Safety Report (CSR) and the exposure scenarios contained within it. It links intrinsic substance properties with realistic conditions of use along the supply chain and describes effective risk management measures (RMMs).
Manufacturers and importers with an annual volume of 10 tonnes or more must conduct and document the CSA. The evaluation is carried out in stages: first, hazardous properties are identified according to CLP criteria, and subsequently, exposure is estimated under normal and reasonably foreseeable conditions of use. This determines whether the use is safe or if additional protective measures are required.
Operationally, compliance officers should consider the following aspects during the CSA: identifying data gaps for targeted testing strategies, properly applying QSAR models and read-across approaches, and updating the assessment in light of new scientific findings or altered uses. Consistency between the CSA, CLP classification, and safety data sheets (SDSs) is a regulatory requirement — discrepancies lead to complaints from the ECHA or national authorities.
For downstream users, the following applies: if your own use falls outside the exposure scenarios communicated by the supplier, you must prepare your own CSA or report the use to the supplier. Automated tools for managing exposure scenarios significantly reduce manual effort and ensure the correct assignment of RMMs to specific activities.
Key Points
- Mandatory for manufacture or import volumes ≥10 tonnes per year under REACH registration
- Includes hazard assessment, exposure assessment, DNEL/PNEC derivation, and risk characterisation
- Results are integrated into Chemical Safety Reports (CSR) and extended Safety Data Sheets (eSDS)
- Must be updated in the event of new uses, altered volumes, or new hazard data
- Consistency with CLP classification and supply chain information is a regulatory requirement
- Downstream users must verify whether their use is covered by the supplier's exposure scenarios
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