Ekotox Centers offer consultancy for EU chemicals law: REACH Registration, Only Representative, Authorisation, REACH/CLP Screening, Safety Data Sheets, Legal Compliance.
We offer to you advisory as follows:
- Elaboration of Chemical Safety Report (CSR)
- Elaboration of Exposure Scenario (ES)
Chemical Safety Reports (CSR) are the main end point for data assessment under REACH in which hazard and exposure data are considered together to assess the risk of a substance.
Manufacturers or importers handling substances over 10 tonnes annually must complete a chemical safety assessment (CSA). This assessment is documented in their chemical safety report (CSR) as part of the registration process.
The Chemical Safety Report (CSR), part of the registration dossier, should detail CSA results. Additional reporting guidance is in Part F of the chemical safety assessment instructions.
Chemical Safety Assessment includes the following steps:
- human health assessment
- physicochemical hazard assessment
- environmental hazard assessment
- Persistent, Bioaccumulative and Toxic (PBT) and very Persistent and very Bioaccumulative (vPvB) assessment (or substances of similar concern)
If the substance meets dangerous classification or PBT/vPvB criteria, the CSA shall also include:
- ® An exposure assessment for all identified and relevant uses of the substance and resulting life cycle steps, including the generation of exposure scenario(s).
- ® A risk characterization which is the final step in the chemical safety assessment.
It consists of a comparison of the derived no effect levels (DNELs) and predicted no effect concentrations (PNECs) with calculated exposure concentrations respectively to human and the environment.
The output of the CSA will be exposure scenarios with operational conditions and risk management measures for adequate risk control.
Exposure scenarios
An exposure scenario defines conditions for substances (in products) and how users control exposure to humans and the environment.
An exposure scenario must have risk management measures and conditions to control associated risks effectively.
To prepare the ES, suppliers will need to liase closely with their customers to ensure that the scenario for exposure is realistic and conversely. Once prepared, the user must not deviate from conditions used for the ES. The user will need to prepare an ES and perhaps even a new CSR to cover their particular use.
More information you can find in the Guidance on Information Requirements and Chemical Safety Assessment: Part D, which provides also links to more in-depth guidance on exposure assessment, in particular how to describe uses, how to collect information on operational conditions and risk management measures, and how to carry out exposure estimates and Part G, which contains the guidance on preparing the extensions to the safety data sheet (SDS) and information how the exposure scenario information is communicated and implemented within the supply chain.
If you have questions please contact us by phone +421 2 45943712, or e-mail to ekotox(at)ekotox.sk