REACH Update: Exposure Assessment Elements

By: Annelie Struessmann, PhD, CONUSBAT

Posted: August 19, 2009

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Key Summary:
• A chemical safety report (CSR) is required for the registration of substances manufactured or imported in quantities of 10 tonnes or more.
• The CSR must contain a chemical safety assessment (CSA) consisting of a minimum of four steps.
• When substances are identified during the initial CSA as meeting the criteria for classification as "dangerous," additional steps for exposure assessment are requested for the CSR.
• The main element of the exposure assessment is an exposure scenario (ES).
• With the ES, the registrant must demonstrate the control of risks during manufacture for a substance and for all its identified uses.
• The ES must communicate operational conditions and risk management measures.
• When a substance is used in a preparation or in an article, it should be determined whether this is an identified use that must be included in the ES.
• The ES must be annexed to the SDS developed in accordance with Article 14 of the REACH Regulation—i.e., for substances manufactured or imported in quantities of 10 tonnes or more.

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