REACH Update: Exposure Scenario Annexes and Other Changes to the SDS

By: Annelie Struessmann, PhD, CONUSBAT

Posted: June 30, 2009

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▪ products containing substances classified as Persistent, Bioaccumulative and Toxic (PBT), and very Persistent and very Bioaccumulative (vPvB), according to the criteria of Annex XIII; and
▪ products containing substances included in the Candidate List of Substances of Very High Concern for potential inclusion in Annex XIV.

Another major new requirement from REACH is that Exposure Scenarios (ES), developed as a result of conducting a Chemical Safety Assessment (CSA), which are required for registrations of quantities of 10 tonnes or more, must be annexed to the SDS. This applies for all identified uses relevant to the recipients of the SDS. The ES must provide advice on how to control risks for the defined uses. It also must include consumer related measures for communication to downstream users manufacturing consumer goods.

Summaries of the risk management measures and the relevant "Derived No-Effect Levels" (DNELs) and "Predicted No-Effect Concentrations" (PNECs) must be given in section 8 of the SDS, which covers exposure controls/personal protection. Similarly, the summaries for technical measures should be included in section 7, which covers handling and storage. The results of the PBT assessment must be summarized in section 12, which covers ecological information. An update of other sections of an SDS, e.g., waste disposal measures, may become necessary based on further results obtained from a CSA. An SDS extended by an ES is often referred to as eSDS.

Key Summary:
• Under REACH, the key communication tool within a supply chain is the Safety Data Sheet (SDS).
• The SDS provides information on the hazard and risk management of a chemical.
• As under the old framework, SDSs under REACH must be provided for substances or preparations that meet the criteria for classification as dangerous.
• New requirements for the classification of chemicals resulted from the CLP regulation, effective since Jan. 20,  2009.
• New requirements from REACH include that the registration number must be revealed in an SDS.
• SDSs are now additionally required for products containing highly hazardous substances.
• The Exposure Scenarios (ES), developed as a result of conducting a Chemical Safety Assessment (CSA) under the provisions of REACH, must be annexed to the SDS.
• An ES must provide advice about how risks can be controlled for identified uses.

For further questions, visit C&T magazine'a online REACH Round Table .