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

June 30, 2009 | Contact Author | By: Annelie Struessmann, PhD, CONUSBAT
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Under REACH, the Safety Data Sheets (SDS) remain the key element for communicating information on hazard and risk management of a chemical substance or preparation within a supply chain. When it entered into force on June 1, 2007, Regulation (EC) No 1907/2006 (REACH) overtook the EU’s provisions for SDSs; therefore, Directive 91/155/EEC, the SDS directive, was repealed. The statutory basis for SDSs is laid down in Article 31 of REACH, and Annex II details the requirements for the compilation of an SDS in accordance with this article.

In comparison to the old legislative framework, the provisions under REACH are widely the same. Similar to the previous legislation, SDSs must be provided for substances or preparations that meet the criteria for being classified as dangerous. However, with the implementation of Regulation (EC) No 1272/2008 on the Classification, Labelling and Packaging (CLP) of Substances and Mixtures, on Jan. 20, 2009, the new classification criteria and the respective deadlines for reclassification given in the CLP regulation apply.

The segmentation of an SDS into 16 sections remains unchanged; however, there are minor modifications and additional information has been requested, including:
▪ a change in sequence for section two on hazards identification and section three on information on ingredients; this new sequence is consistent with the agreements for the UN Globally Harmonized System (GHS);
▪ the headline in section 12 has been changed from "Environmental Information" to "Ecological Information"; and 
▪ additions have been made to section one on the identification of the substance/preparation and of the company undertaking. The registration number for substances subject to registration must be added, along with the identified uses where a Chemical Safety Report is required. In addition, the e-mail address of the competent person responsible for the Safety Data Sheet must be provided. 

These format changes for SDSs were to have been implemented by June 1, 2007, when REACH took effect. However, according to Article 31(9), the SDS should be updated without delay and the new format should be used at that moment, when new information such as hazards or risk management measures, becomes available.

A major change implemented with REACH includes that additional SDSs are required for:

▪ 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 .

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.