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REACH Update: Exposure Assessment Elements
By: Annelie Struessmann, PhD, CONUSBAT
Posted: August 19, 2009
page 3 of 3
• 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.
Readers are reminded that this free service provides basic answers to questions about REACH, but in-depth, consultative services are provided by CONUSBAT for a fee. CONUSBAT reserves the right to determine what information can be provided at no cost, and to refer readers to its services when detailed information is requested.