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Home > Chemical safety assessment > Exposure assessment Exposure assessment |
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The exposure assessment consists of estimating the dose (or concentration) of the substance to which humans and the environment may be exposed. It concerns all the life-cycle of the substance, from the manufacture to the different identified uses. It entails two clear steps:
For substances placed on the market, the relevant exposure scenario(s) and a summary of the exposure estimation shall be included in an annex to the safety data sheet (SDS). There is a standard format for the exposure scenario(s) annexed to the SDS. Development of exposure scenarios Exposure scenarios describe how the substance is manufactured or used and how to control exposures of humans and the environment. It includes both the operational conditions and risk management measures implemented by the manufacturer, the importer or the downstream users. These later are the main recipients of ES and must check the compliance of their requirements with the described conditions of use. The required level of detail for an ES may substantially vary from case to case, depending on the use of a substance, its hazardous properties and the amount of available information. Exposure scenarios may describe the appropriate risk management measures for several individual processes or uses of a substance. In this case, they may be referred to as “Exposure Categories”. As the chemical safety assessment (CSA) process may be iterative, a first exposure scenario is developed thanks to initial assumptions about the operating conditions and risk management measures. The first assessment is based on available hazard information and on the exposure estimation corresponding to the initial scenario. If the initial risk characterisation indicates that risks are not adequately controlled, the assessment must be refined by iteration. Additional hazard information, an alteration of the operational conditions or of risk management measures or a more precise exposure estimation may be necessary to reach an adequate risk control. The scenario obtained after the last iteration, namely the “final exposure scenario”, shall be included in the chemical safety report (CSR). Exposure estimation The exposure estimation, carried out for each developed scenario and described in the CSR, entails the three following elements:
If measured exposure data are available and representative, they shall be specially considered. But appropriate models or relevant monitoring data from analogous substances may also help to the exposure assessment.
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