Ekotox Centers are providing consultancy services and customers support in the area of EU chemicals legislation – REACH Registration, Only Representative, REACH Authorisation, REACH/CLP Screening, Safety Data Sheets, Legal Compliance Services.
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.
A manufacturer or importer of a substance in quantities of 10 tonnes or more per year needs to prepare a chemical safety assessment (CSA) and needs to document this assessment in his chemical safety report (CSR) as part of his registration dossier.
The Chemical Safety Report(CSR) submitted to the Agency as part of the registration dossier must document the results of the CSA. The CSR template is structured according to section 7, Annex I of REACH and provides a more detailed breakdown. Further guidance on how to report the information in a CSR can be found in Part F of the Guidance on information requirements and chemical safety assessment.
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 the criteria for classification as dangerous, or meets the 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). An exposure estimation of humans and the environmental compartments to the substance is performed from the conditions defined in the exposure scenarios.
- ® A risk characterization which is the final step in the chemical safety assessment. The risk characterisation identifies if the risks arising from manufacture/import and uses of a substance are adequately controlled.
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 have to be documented in the Chemical Safety Report (CSR) and communicated to the downstream users as annexes to the Safety Data Sheets.
An exposure scenario is a set of conditions that describe how a substance (as such, in a preparation or in an article) is manufactured or used during its life-cycle and how the manufacturer or importer or downstream user controls or recommends controlling exposure of humans and the environment.
An exposure scenario must include the appropriate risk management measures and operational conditions that, when properly implemented, ensure that the risks from the uses of the substance are adequately controlled.
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. For specialist uses, or if the use is considered confidential, 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