The Annex to the SDS is currently only required for substances which have been registered under REACH at 10 tonnes per annum or above, including where a use has been registered separately from the main registration, where a Chemical Safety Report has been produced. ECHA provide a free software tool, CHESAR, to help you write a CSR, see https://chesar.echa.europa.eu/ .
The Chemical Safety Report includes the Exposure Scenarios for each registered use for the substance, which is the set of conditions that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These sets of conditions contain a description of both the risk management measures and operational conditions which the manufacturer or importer has implemented or recommends to be implemented by downstream users.
An Exposure Scenario is in two parts:
- Operational conditions
- the processes involved, including the physical form in which the substance is manufactured, processed and/or used,
- the activities of workers related to the processes and the duration and frequency of their exposure to the substance,
- the activities of consumers and the duration and frequency of their exposure to the substance,
- the duration and frequency of emissions of the substance to the different environmental compartments and sewage treatment systems and the dilution in the receiving environmental compartment.
- Risk Management Measures
- the risk management measures to reduce or avoid direct and indirect exposure of humans (including workers and consumers) and the different environmental compartments to the substance,
- the waste management measures to reduce or avoid exposure of humans and the environment to the substance during waste disposal and/or recycling.
The Exposure Scenarios for all the registered end uses you are supplying should be taken out of the CSR and placed in the Annex.
If you receive an SDS with Exposure Scenarios, you must pass this information down the supply chain. Where there are many possible uses for a substance, the Annex can become very large and unwieldy. If you are selling on the substance for only some uses, it is sensible to only include those uses in the Annex, rather than duplicating un-necessary information.
SDS Annex and Mixtures
The SDS Annex can be used for mixtures in two ways:
- either use it for the Safe Use of Mixture Information document, which is being brought in
- or use it to attach relevant exposure scenarios for component substances
However, if the author of the SDS considers that all of the safe use information has already been incorporated in the main body of the SDS (mainly in Section 8), then the Annex is not required.
For more information on the SUMI format, which consolidates safety information for the mixture as a whole, see the DUCC website at http://www.ducc.eu/Publications.aspx .