Extended safety data sheets
Safety data sheets
Safety data sheets include information about the properties of the substance or mixture, its hazards and instructions for handling, disposal and transport and also first-aid, fire-fighting and exposure control measures. The format and content of the safety data sheets are specified in REACH. A safety data sheet should be provided to downstream users for:
- A substance or mixture that is classified as hazardous according to CLP.
- A substance that is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), or
- A substance that is included in the Candidate List of substances of very high concern (SVHCs).
However, if the substance or mixture is also sold to the general public, an SDS does not need to be provided unless requested by a downstream user or distributor.
For mixtures which are not classified as hazardous but which contain certain hazardous substances, an SDS should be provided if requested by downstream users or distributors.
The safety data sheet should be updated without delay if new information becomes available on the hazards or the need for more stringent risk management measures.
When downstream users receive a safety data sheet, they need to identify and apply appropriate measures to adequately control the risks. Suppliers and recipients of SDSs are encouraged to check that the required information is provided. A checklist was developed by ECHA and enforcement authorities and is available for this purpose. Downstream users are encouraged to inform their suppliers about inaccuracies or inconsistencies in the SDS received.
When safety data sheets are not required, the supplier must still provide sufficient information for safe use. If restriction or authorisation applies to any substance, the necessary details should be provided. Suppliers of articles that contain more than 0.1% w/w of a substance on the Candidate List have to provide enough information to allow the safe use of the article to downstream users and distributors.
Exposure scenarios provide information on how the exposure of workers, consumers and the environment to hazardous substances can be controlled during use. Relevant exposure scenarios should be included as an annex to the safety data sheet of a substance when a company in the supply chain has carried out a chemical safety assessment under REACH.
Harmonisation and automation are essential elements for efficient communication. To support this, a common layout format for the exposure scenarios was agreed and the ESCom catalogue of standard phrases and IT format (ESComXML) were developed. This allows an automated exchange of harmonised information on the safe use of chemicals between various actors in the supply chain and their own systems.
When downstream users receive exposure scenarios, they must check that they cover their own use of the substance and their conditions of use or take alternative action.
The formulator of hazardous mixtures must identify the relevant information from the exposure scenarios to communicate , and also how best to communicate this information
Two approaches have been developed by industry to identify the information to communicate. One approach, called "safe use of mixtures information" (SUMI), is where sector organisations identify the risk management measures for typical products and uses within the sector. They generate SUMIs giving this advice in a user-friendly way and based on an agreed template.
The formulators select the appropriate SUMI for their product, and check that it is consistent with the exposure scenarios received from their suppliers. An explanatory document has been published by DUCC, the Downstream Users of Chemicals Coordination group.
The second approach, called the "lead component identification" (LCID), is intended for situations when a suitable SUMI is not available. The formulator identifies the lead components in a mixture and derives safe use information for the mixture from the risk management measures for the lead components. Cefic has published a practical guide on the LCID methodology.
Formulators can choose to communicate the relevant information from the exposure scenarios of the ingredient substances in a number of ways:
This is suitable when the recipients are end users and when there are a relatively small number of identified uses and/or consistent conditions of use and risk management measures.
This is suitable when there are a range of uses with different conditions of use. A harmonised format has been agreed among sector organisations, called SUMI template.
This is suitable when the recipients are also formulators, and generate safety data sheets for their own mixtures. It may also be suitable for end users of the mixture when the appropriate risk management measures for an identified use are clearly specified in one exposure scenario for each identified use. When there are multiple suppliers of the same substance, a consolidated exposure scenario may be generated.
For more information on the different options and their applicability, see section 7.2 of ECHA's Guidance for Downstream Users.
Safety data sheets guide
- Guidance on the compilation of safety data sheets [PDF] [EN]
- Languages required for labels and safety data sheets [PDF] [EN]
- SDS checklist
- PG 13 - How downstream users can handle exposure scenarios [PDF][EN]
- Annotated template
- Factsheet on communication obligations [PDF][EN]
- Factsheet on safety data sheets and exposure scenarios [PDF][EN]
- Examples of exposure scenarios
- Questions and answers on safety data sheets