REACH Update: Exposure Assessment Elements

By: Annelie Struessmann, PhD, CONUSBAT

Posted: August 19, 2009

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Further elements of the exposure assessment are exposure estimations and risk characterizations, which must be conducted for each ES. They also must demonstrate the risks that are controlled. Estimates on the expected exposure to humans and the environment must be compared to the no effect levels determined in the initial steps of the CSA. WIth that, the registrant demonstrates that the risks are controlled.

The detail level for an ES depends upon the use of a substance, its hazardous properties and the amount of information available. The ES should describe all relevant factors determining the exposure using a standardized structure. An ES may summarize the information for several individual processes or uses of a substance. The REACH term for an ES covering a wide range of processes or uses is Use and Exposure Category (UEC), according to definition in Article 3(38).

When a substance is used in a preparation, an ES may need to be developed for this use, and manufacturers or downstream users may initiate this process. Also, the incorporation of the substance into an article may be an identified use, which should be included in the CSR.

An ES must be annexed to a safety data sheet (SDS). Also, summaries of the results from the exposure assessment have to be added to the various chapters of the SDS. For questions on the SDS, please refer to the REACH Update Exposure Scenario Annexes and Other Changes to the SDS.

If an agreement among the members of a SIEF is reached, the Chemical Safety Report (CSR) of the substance can be jointly submitted.