This website or its third-party tools use cookies, which are necessary to its functioning and required to achieve the purposes illustrated in the cookie and privacy policy.
The GES consolidates the relevant Exposure Scenario (ES) information and presents it in a concise, understandable format that reflects the whole mixture. In doing so, it moves the responsibility for interpreting the often complex and confusing information received on to the formulator. Several GESs have been developed to cover the range of identified lubricant use groups for industrial and professional applications.
An additional benefit is that the attachment of a mixture GES, as an annex to the SDS, makes it clear to customers (and potentially REACH inspectors) that formulators have met their legal obligation to pass on safe use information.
This ATIEL/ATC approach also aims to ensure that consistent ES information for classified lubricant mixtures is passed to industrial and professional customers, regardless of whether a Downstream User (DU) Chemical Safety Assessment (CSR) has been completed or not.
Q1: Am I obliged to register all uses identified by my downstream user?
Q2: If I am a manufacturer of a component used in the identified applications what do I need to do?
The Generic Exposure Scenarios (GES), developed by ATIEL/ATC, consolidate various ES information relating to the constituent substances of the mixture. This avoids the requirement for repeated updates of SDSs when new substance ESs are received by the formulator, as the need for the attached mixture GES to change is minimised. This GES approach has been developed over several years with input from experienced experts in the additive and lubricants industries.
If the formulator, as a Downstream User (DU), is required to prepare his own Chemical Safety Report (CSR) and ES for a constituent substance (according to REACH Article 37), this ES is required to be placed in an Annex to the SDS. This requirement may arise, for instance, if the substance ES for one of the mixture components does not cover the use of the substance in lubricants or does so in a way that the risk management measures or operational conditions are unrealistic.
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).
Therefore the controls identified within each GES are expected to be sufficient to address the risks associated with typical components. It is the expectation of the working group that most Lubricant products should fit within the boundary conditions of the relevant GES specified in this process. However, for products that do not fit into the boundary conditions matrix, it will be necessary to develop an exposure scenario specific to that product, and the GES provides a starting point.
The application of the GES process is not considered to require a DU CSA notification to ECHA. However, for products that do not fit into the boundary conditions matrix, it will be necessary to develop an exposure scenario specific to that product, and the GES provides a starting point.
Fuel Additives - ATC
Process oils - CONCAWE
Asphalts - CONCAWE
Solvents - ESIG
Cleaning agents - AISE
Paints & coatings – CEPE
Please also refer to Q & A number 9 as options 1 and 3 may also provide a solution for a downstream user in these circumstances.
Automotive manufacturing site |
Car dealer / workshop or local garage |
D-I-Y Oil change |
Industrial | Professional | Consumer |
If your use is not covered by your supplier's registration you have the following options:
1. Adapt your conditions of use to those operating conditions and risk management measures described in the supplier’s eSDS.
2. Perform your own chemical safety assessment for that particular use and record it in a Chemical Safety Report - CSR (if the total amount used is 1 tonne/year or more). This CSR has to be made available to local REACH enforcement authorities on request and ECHA has to be notified. The notification to ECHA needs to indicate the name of the substance, the use for which an assessment has been carried out, and the identity of the supplier. ECHA should be notified within six months following the receipt of a registration number from your supplier that you have prepared your own CSA. There is no requirement to send the CSA you have prepared to ECHA.
3. Switch to another supplier of the substance if that supplier covers your specific use in his eSDS.
- The CAS number may relate to a substance which does not have a 2010 registration deadline in which case the SIEF may not yet be active.
- There is no legal requirement for a Lead Registrant to advise ECHA of their status and so the SIEF maybe active but ECHA have not been advised.
- As a result of REACH activities, especially substance sameness discussions, some pre-SIEFS split or merged resulting in changes to substance identities. If this is the case it will become clear when an updated Safety Data Sheet is issued by your supplier.
- Your supplier may be using generic identifiers in section 3 of the Safety Data Sheet which satisfies the product stewardship obligations to report hazardous substances but for REACH registration purposes more precise identifiers are required. If you remain concerned then you should contact your supplier directly for further information.
If you have any queries relating to the ATIEL/ATC Generic Exposure Scenarios or the process for applying them please contact: This email address is being protected from spambots. You need JavaScript enabled to view it.