REACH Update: Exposure Scenario Annexes and Other Changes to the SDS
By: Annelie Struessmann, PhD, CONUSBAT
Posted: June 30, 2009
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No 1907/2006 (REACH) overtook the EU’s provisions for SDSs; therefore, Directive 91/155/EEC, the SDS directive, was repealed.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: