Chemical Safety Report (KGR/CSR) is a comprehensive assessment documenting the risks and control methods of the substance, mandatory for substances recorded in quantities of 10 tonnes per year and above.
Preparatory stages: hazard assessment (human health and environment); PBT/vPvB assessment; exposure assessment and creation of scenarios for harmful substances; risk characterization. Exposure scenarios are reflected in the extended SDS (eSDS).
The quality of the KGR directly affects record acceptance and audit durability. ONAY Mühendislik Prepares KGR and makes it compatible with SDS.
When is a Report Required?
Chemical safety reporting is mandatory for substances above a certain tonnage threshold. The report is a document that evaluates the risks of the substance on human health and the environment and shows that these risks are under control. No report is required for substances below the threshold; However, when the tonnage band increases, the report must be prepared.
Stages of Evaluation
Report; It starts with human health hazard assessment, physicochemical hazard assessment, environmental hazard assessment and persistent, bioaccumulative, toxic substance assessment. If the substance is classified as hazardous, exposure assessment and risk characterization are included. These last two stages are the most labor-intensive parts of the report.
Determination of Derived No Effect Levels
The basis of risk characterization is the determination of derived no-effect exposure levels for humans and estimated no-effect concentration values for the environment. These values are derived by applying evaluation factors from existing test data. Justification of factor selection is the most critical point of the scientific defensibility of the report.
Generation of Exposure Scenarios
An exposure scenario is generated for each identified use of the substance. In the scenario, operational conditions and risk management measures are defined, the estimated exposure is calculated and proportioned to the derived no-effect level. A ratio below one indicates that the risk is under control. These scenarios are then transmitted to the supply chain as an annex to the extended safety data sheet.
Time Management in Report Preparation
Report preparation requires data gaps to be closed; Therefore, it goes hand in hand with testing processes. Additionally, it takes time to collect actual usage conditions from the field. Starting the report close to the registration deadline creates a document that is often based on assumptions and difficult to defend.
Link Between Chemical Safety Report and SDS
Exposure scenarios produced in the Chemical Safety Report are transmitted to the supply chain as an annex to the extended safety data sheet. In other words, the report is not only a document presented to the institution, but also the source of the information you send to your customers. These attachments must also be redistributed when the Chemical Safety Report is updated.
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Official full text of the regulation: KKDIK Regulation - Official Gazette.