Exposure Scenarios: Chemical Safety Assessment

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Exposure Scenarios: Chemical Safety Assessment

Exposure Scenarios: Chemical Safety Assessment

16.04.2024

Exposure Scenarios and Chemical Safety Assessment

Exposure scenarios play a significant role in the safe use and management of chemicals, ensuring they do not harm human health or the environment. This article will discuss what chemical exposure scenarios are, how they function, and their relationships with KKDIK and the Extended Safety Data Sheets (eSDS – gGBF in Turkish).

What is an exposure scenario?

An exposure scenario (ES) is a document designed to manage the exposure of humans and the environment to a specific substance. According to the KKDIK Regulation, exposure scenarios can cover specific processes or uses of a substance or several processes or uses. These scenarios include information on how the substance is manufactured, how it is used throughout its life cycle, exposure controls, related recommendations, operating conditions, and risk management measures.

With exposure scenarios, exposure estimation and associated risk characterization are provided throughout the entire life cycle of the substances that require chemical safety assessment, in other words, in the processes from manufacturing to disposal or in all defined uses. This helps to define under which conditions the substance should be used to ensure its safe application.

Chemical Safety Assessment

It is well known that chemicals are widely used in everyday life. If not effectively managed—that is, if their risks are not accurately assessed—serious health problems, environmental pollution, and risks of unsafe use could arise. Therefore, chemical safety assessment is crucial.

Chemical safety assessment involves evaluating the intrinsic properties of the substance, its harmful characteristics, usage conditions, and risk management measures to ensure safe usage throughout its defined life cycle.

Exposure Scenarios and REACH

As is known, the purpose of the REACH Regulation is also to protect human health and the environment from the adverse effects of chemicals. The regulation published for the adaptation of this Regulation to Turkish legislation is the KKDIK Regulation. According to the KKDIK Regulation, one of the critical points in chemical safety assessments is the exposure scenarios. Under the KKDIK Regulation, a chemical safety report must be prepared for all substances registered in quantities of ten tons or more per year (CSR), and for substances classified as hazardous or as PBT or vPvB according to the SEA Regulation, exposure scenarios must also be included.

Exposure Scenarios and eSDS

Another important tool for ensuring the safe use of chemicals is the Extended Safety Data Sheets (eSDS). These forms include information such as the physical and chemical properties of the chemical substance, hazard classifications, protective measures, emergency procedures, and appropriate personal protective equipment. The purpose of safety data sheets is to ensure access to relevant information about the substance for downstream users, and consumers if applicable. According to the KKDIK Regulation, an exposure scenario might need to be added to the safety data sheet under certain conditions. In such cases, the relevant scenario is presented as an annex to the safety data sheet.

The extended safety data sheets aim to maximize the safe use of chemicals. Exposure scenarios define the conditions under which a specific chemical can be safely used in all defined uses and all processes and guide the determination and implementation of safety measures in the workplace. All downstream users are required to comply with the usage conditions specified in the exposure scenario.

Conclusion

In summary, exposure scenarios are documents that must be prepared according to the KKDIK regulation, included in the chemical safety report, and provided to downstream users in the annex of eSDS. The purpose of preparing these scenarios is to ensure safe use conditions throughout all life cycle stages of a chemical and to secure the safe usage of all downstream users by ensuring the flow of information. However, it should be noted that not every registrant is required to prepare an exposure scenario. A registrant might be obligated to prepare a chemical safety assessment and chemical safety report but might not be required to prepare an exposure scenario. Therefore, the relevant regulations should be carefully reviewed to determine the requirements and take appropriate action. To ensure the maximum safe use of chemicals, all requirements should be considered, and a holistic approach should be adopted.

To learn about your obligations related to exposure scenarios and to benefit from our related services, please contact us.

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