Improving the workability and quality of extended Safety Data Sheets

Date: 18 December 2018

In the course of the recent meeting of the competent authorities for REACH and CLP (CARACAL) the member states, the Commission, ECHA and stakeholders discussed how to improve the workability and quality of extended Safety Data Sheets.
The Safety Data Sheet is a mandatory tool for suppliers of hazardous chemicals (substances and mixtures) to provide the users with safety-relevant information. For substances that require a Chemical Safety Report to accompany the registration dossier, the corresponding Exposure Scenarios (ESs) extend the traditional Safety Data Sheet (SDS) to an extended SDS (eSDS), with information on use- or task-specific conditions of safe use.
ECHA has identified a number of root causes that affect the workability and quality of the extended safety data sheet.

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  • The legal text and ECHA guidance leave it open how exposure scenarios of substances are to be included into the mixture safety data sheet (SDS).
  • There is no common understanding whether an SDS for a mixture should have an exposure scenario (ES) Annex like the substance-related SDS, and whether users of mixtures have downstream users’ duties under REACH.
  • Similarly, the relationship between the ES Annex and Sections 7 and 8 of the SDS is not clearly described in Annex II of REACH, and thus leads to difficulties for recipients of an SDS to identify the information needed for checking their conformity.

The lack of harmonisation/standardisation regarding the data format of the extended SDS prevents the transfer of data in a way that IT systems could directly process the information received. As a consequence, at the moment, all information is to be uploaded manually into tools for processing (when they exist), which consumes a lot of resources and is error prone.

In addition, there is no common assessment standard supporting all the expected processing of safe use information through the supply chain by the various actors. IT providers have developed a variety of solutions for some of the tasks (mainly based on the clearly enforceable duties). The language of the Annex to the safety data sheet is an illustrative example, easy to check for inspectors but coherent translation is very challenging for IT providers.

The Commission (COM) and ECHA thus called for feedback regarding the experience with current (harmonised) formats and IT tools. Afterwards COM and ECHA will organise a workshop to make proposals for follow on work. The Commission considers including minimum requirements for the exposure scenarios for substances and mixtures in Safety Data Sheets and requesting ECHA to develop a methodology for Safety Data Sheets for mixtures. The results thereof and possible implementation in the legal text may require years. Until then the current status remains.

The Exchange Network on Exposure Scenarios (ENES) has developed harmonised formats and IT tools (e.g the EuPhraC catalogue for standard phrases). However, uptake and use of the ENES tools remains limited.
Within this context please refer to our news item regarding eSDS translation.