The safety data sheet (SDS) is the main tool for hazard communication and risk management measures (RMMs) in the supply of chemical products. A SDS shall be supplied on paper or electronically at the latest at the time of the first delivery of a chemical substance. Suppliers shall update it without delay on the following occasions: - As soon as new data which may be necessary to enable appropriate risk management measures to be identified and applied become available
- Once the substance has been registered
- Once an authorization has been granted or refused
- Once a restriction has been imposed
The new, dated version of the information, identified as the revision date shall be provided free of charge to all former recipients to whom they have supplied the chemical substance or preparation within the preceding 12 months. REACH has introduced some major changes in the format for compilation of SDS to be submitted to ECHA by a company, to ensure safe use of chemicals and to adequately manage any risk arising out of a chemical accident.
Section 2 of the SDS to be prepared within REACH will be the ‘hazards identification’ and Section 3 deals with ‘composition/information on ingredients’. This constitutes a reversal of these Sections compared to the current practice. This re-formatting is to bring the EU SDS in line with international SDS requirements under the United Nations Globally Harmonised System (GHS). The GHS will replace the current system of classification and labelling and will introduce new hazard symbols. The biggest change to the SDS under REACH is the addition of an Annex containing the exposure scenario(s) (ES) derived from the Chemical safety report (CSR), to give the so-called extended SDS (ext-SDS). An ext-SDS is required only for chemicals exported over 10 tons per annum and persistent, bio-accumulative and toxic (PBT)/ very persistent, very bio-accumulative (vPvB) substances. The ES will prescribe the operational conditions and RMMs necessary for safe use. The main changes for the new SDS under REACH are given below:
Section 1: E-mail of competent person responsible for the SDS should be added. Registration number added. It is recommended that the use heading in Section 1 should be generic use conditions (closed systems, open systems operated by trained staff, etc) and application conditions (use in textiles, printing inks, etc.)
Sections 2 and 3 are reversed, compared to current practice.
Section 3: (Information on ingredients). PBTs and vPvBs should be mentioned if present in quantities greater than 0.1%. Registration numbers should also be given, when available.
Section 8: Where a chemical safety report is required, the relevant derived no-effect levels (DNELs) (health) and predicted no-effect concentrations (PNECs) (environment) for the substance shall be given for the exposure scenarios set out in the annex to the SDS. Summary of the RMMs for both health and the environment are required here too, for the ESs given in the annex to the SDS. For preparations, it is useful to provide values for those constituents which are required to be listed in the SDS in Section 3.
Section 11: Information on toxicokinetics, metabolism and distribution. Statement on the CMR category 1 or 2 status of the substance or preparation.
Section 12: Results of the PBT/vPvB assessment, and the emission characterization (only required if the PBT and vPvB conditions are met) shall be summarized in Section 12 of the SDS. Effects such as ozone depletion, photochemical ozone creation potential, and strong odour and tainting should be summarized in the SDS for substances with chemicals with a CSR. Information, if available, on endocrine disrupting potential should be included.
Section 15: Indicate if a Chemical Safety Assessment (CSA) has been carried out for the substance, or a substance in the preparation. Authorisation under Title VII of REACH and restriction under Title VIII of REACH and relevant national measures applied to the substance should be mentioned here.
Section 16: Full risk (R) and safety (S) phrases as usual, but also reasons for inclusion in Section 3 if appropriate (i.e. PBT or Community workplace exposure limit). Uses advised against (recommended restrictions on use; non-statutory recommendations by the supplier).
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Safety Data Sheet (SDS)