ECHA and industry guidance documents recognise that there are three ways for formulators to convey ES information for their mixture component substances, which must be done via the SDS for the mixture:
1. Attach the substance Exposure Scenarios (received from suppliers) for all relevant substances in the mixture.
2. Attach a “Mixture Exposure Scenario” which consolidates relevant ES information about the constituent substances.
3. Embed into the main body of the mixture SDS (in sections 7, 8 and/or 13) consolidated and relevant ES information about the constituent substances.
Note that none of the above options allows the formulator to avoid the need to pass on pertinent information to the customer.
End users have a legal duty to act on the information received. We strongly believe that the ATIEL/ATC approach (using option 2 above for classified mixtures) is the best option to take into account the composition, uses and supply chain of lubricant mixtures and can provide practical benefits for the end-user, for the following reasons:
• The combination and consolidation of substance ES information allows understandable, relevant & consistent information that properly reflect the whole mixture to be passed to customers in a succinct manner.
• It moves the responsibility for interpreting complicated and often contradictory information in substance ESs on to the formulator.
• The attachment of a mixture GES makes it clear (to customers and REACH inspectors) that the formulator has discharged its legal obligation to pass on information and the format allows this information to be easily found by the customer.
• The ATIEL/ATC approach ensures consistency in ES information passed to industrial and professional customers, regardless of whether a DU CSR has been completed or not.
In contrast, although option 1 looks like the easiest option, it may have the following drawbacks:
• Information from substance registrants is often confusing and received in different formats.
• There can be contradictions between the OCs and RMMs in the ESs for different substances in the same mixture which the formulator is best placed to resolve.
• The substance ES may have been developed based on its presence at a higher concentration than is actually used in the mixture, suggesting more stringent controls than are actually required.
• The information may generate a large document which could be difficult for end-users to interpret.
• The mixture SDS will need to be updated every time a new ES for a constituent substance that appears in Section 3 is received.
Option 3 (embedded information in the main body of the SDS) has the drawbacks that:
• It may not be clear to the customer or inspector if and how the legal duty to pass relevant ES information down the supply chain has been discharged by the formulator and acted upon by the customer.
• It may lengthen considerably the main body of the SDS (by embedding all the ES information) and not separate out ES information that is aimed at a potentially different target reader (e.g. industrial hygienist or environmental engineer vs. user of the mixture).