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REACH Update: Downstream User Obligations, Identified Uses and Use Descriptors
By: Annelie Struessmann, PhD, CONUSBAT
Posted: September 22, 2009
If an ingredient supplier submits an extended safety data sheet (eSDS)—a safety data sheet (SDS) with an annexed exposure scenario (ES)—to a downstream user (DU), the recipient needs to comply with the conditions described in the attached ES. Additionally, if the DU's use is not covered, the DU will be responsibile to develop a chemical safety report (CSR). An eSDS will only be received if a REACH registration was filed for quantities of 10 tonnes or more of a substance and if the substance meets the criteria for classification as dangerous. For more information on ES annexes and other changes to the SDS, read the June REACH Update.
This responsibility for the DU to file a CSR applies when the amount of the substance as such or in a preparation as part of the DU's processes reaches one tonne per year or more, whereas the amount is not limited to the actual applied quantity but also includes the quantity stored.
When obtaining the eSDS, the DU must identify if the ES contains the specific operational conditions and risk management measures applied to that DU's uses and operations. In relation, the following criteria must be reviewed upon receiving an eSDS:
• Does the description of use(s) given in the first part of a standardized ES include the way in which the substance is used by the DU?
• Do the operational conditions as described in the ES cover the DU’s use? i.e., do the DU's operations assure human and environmental exposure at reduced or equal levels?
• Do the risk management measures of the ES match the procedures applied by the DU to protect workers, consumers, or the environment?
If the ES of the supplier does not cover the DU’s operational conditions and risk management measures, or the DU’s use of a substance or a preparation is not covered at all, various options exist for the DU, and a decision for the best approach has to be made on a case-by-case basis. Possible steps could include:
• Adjusting to the supplier's conditions of use described in the eSDS; i.e., changing work practices;
• Notifying the supplier of the new use with the aim of making it an identified use within the registrant’s chemical safety assessment;
• Performing a chemical safety assessment;
• Changing to a different supplier of the substance;
• Considering replacing the substance or preparation with those that are less hazardous.