Last reviewed 11 July 2019
In this special report, Christine Lepisto of Chemical Safety Consulting, Germany, explains the background to, and the development of, Safe Use of Mixtures Information (SUMIs) documents. She also discusses how they differ from workplace safety information cards, the time frames and the next steps.
The exposure scenarios (ESs) from your suppliers are starting to pile up — after longer than expected delays as companies already through the 2010–2013 registration deadline “starting gates” have struggled and juggled to get their extended safety data sheets (eSDSs) out into the supply chain.
You have been checking that your uses are covered, and that your operations comply with the operating conditions (OCs) and risk management measures (RMMs) described by your supplier (or you have started your own chemical safety assessment (CSA) in case you cannot see eye to eye with your supplier on these points). Articles 37 and 38 of the EC Regulation 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) establish clear timelines: 12 months to comply and 6 months to notify the European Chemicals Agency (ECHA) if you do your own CSA.
You know you also have to communicate your suppliers’ safe use information for your mixtures to your downstream users. However, what does this mean, really? When does it have to be done?
The ECHA Exchange Network on Exposure Scenarios (ENES) offers a good place to start. This collaborative network established by ECHA together with sector associations European Chemical Industry Council (Cefic), Concawe, Eurometaux, Fecc, AISE and Downstream Users of Chemicals Co-ordination (DUCC) has developed guidance on how to comply with obligations for safe use information for mixtures. Two important sets of documents released recently outline the top-down and bottom-up approaches to the issue of communication of safe use information.
In this article, after a short refresher on the topic of ESs and SDSs and an overview of the obligations established by REACH, we will discuss all of the options for compliance in order to get some context on when to use which approach and then will delve deeper into the bottom-up approach now being called Safe Use of Mixture Information (SUMI).
Extended safety data sheets?
First, a short reminder on eSDSs and ESs?
An eSDS consists of the usual 16-section format with an annex added onto it. The annex contains “exposure scenarios”.
An Exposure Scenario means “a set of conditions, including operational conditions and risk management measures, that describe how a 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 exposures scenarios may cover one specific process or use or several processes and uses as appropriate”
— REACH Article 3.37
These ESs include a substance when in a mixture or article.
The ESs summarise the approved uses, OCs and RMMs that were determined by the manufacturer or importer of a substance in the CSA conducted in accordance with REACH.
A CSA is required in REACH only for substances at thresholds ≥ 10t/year/legal entity and only if the substance meets one or more of the following criteria.
Hazardous in accordance with the EC Regulation 1272/2008 (CLP), as amended, classification scheme.
Persistent, bioaccumulative and toxic (PBT).
Very persistent and very bioaccumulative (vPvB).
There are valid reasons why you may not receive an eSDS for a raw material.
Substance is exempted from REACH registration.
REACH registration deadline is in 2018.
Substance is not hazardous or PBT/vPvB.
Substance does not exceed 10t/year/legal entity supplying it.
SDS supplied voluntarily (hazardous substance concentration below classification thresholds).
Communication in the supply chain
REACH requires that the safety information developed for substances must be passed down the entire supply chain. The requirement technically stems from Article 31, paragraph 7 of REACH:
“Any actor in the supply chain who is required to prepare a chemical safety report according to Articles 14 or 37 shall place the relevant exposure scenarios (including use and exposure categories where appropriate) in an annex to the safety data sheet covering identified uses and including specific conditions resulting from the application of section 3 of Annex XI.
Any downstream user shall include relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for identified uses.
Any distributor shall pass on relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheets for uses for which he has passed on information according to Article 37(2).”
— REACH Article 31(7)
ECHA has clarified in its Guidance on the Compilation of Safety Data Sheets (Version 3.1, p. 26, footnote 27) that this article requires manufacturers and importers, who must perform a Chemical Safety Report (CSR), to attach all relevant ESs in an annex to the SDS. However, downstream users (who are not themselves doing a CSR) have other options available, including:
integrate the information into the main body of the SDS
append safe use information for the mixture to the SDS
attach the relevant ESs for the substances in the mixture as an annex.
In the best case, a supply chain consists of one company manufacturing a substance and one “downstream user” that consumes the substance entirely. In most cases, though, supply chains are substantially more complex, with the manufactured or imported substance being added to mixtures which continue down the supply chain, where mixtures become raw materials for further mixtures or reaction processes. As long as a professional or industrial user purchases the product, the supply chain remains subject to the REACH Regulation.
Deciding which option to use to communicate safe use information for mixtures depends on the nature of the supply chain. Different approaches may be necessary at different points along the supply chain.
Pass it on
Option 3 offers the easiest route to meet the REACH requirement. You can simply put all of the annexes of all of the substances in your product together and send them on to your customer. Since these annexes can run to a thousand pages for a single substance, that might not make your customer very happy. One should ask whether the option used effectively communicates the information.
There is one case in which option 3 is exactly, in the author’s view, the right thing to do though — regardless of how many pages of annex to an eSDS end up attached to a particular mixture. If your customer is going to formulate (blend) your mixture into yet another mixture, then it is best for them to treat every substance in your mixture as if they bought the substance itself. When they decide the best method for communicating the safety information relevant to their mixture, they need to have access to the safety information for all of the substances in their own product.
It is still important in this case to ensure that the information in the annexes passed on is consistent with the SDS that accompanies the package.
For simpler mixtures, it may be possible to capture the key safety information covered in ESs and integrate it into the body of the SDS — mostly into sections 7 (Handling and Storage) and 8 (Exposure Controls/Personal Protection). This is especially true if the product in question has a market for specific and limited uses but may be done also for products where multiple ESs can be outlined within the body of the SDS.
Selecting this option will not get your company experts out of familiarising themselves with the SUMI and Lead Component Identification (LCID) approaches discussed further below, because deciding what information to communicate for a mixture of substances with competing and redundant advice presents the true challenge, regardless of whether the resulting information is integrated or annexed.
SUMIs v LCID
In order to reduce the complexity of safety advice for mixtures and to set out this ES information clearly, most companies will probably choose the middle option: append safe use information for the mixture to the SDS.
Two approaches to identify the correct information to append have arisen out of industry’s collaborative efforts to define new processes for meeting these new obligations. The first option has been described as bottom-up because it starts with the users at the bottom of the supply chain. These users are not formulating products, but using chemical mixtures — for example, as inks and coatings, for industrial maintenance or professional cleaning, or to manufacture articles.
The bottom-up approach takes its name, SUMI, from the name of the document that is created to serve as the annex. The DUCC led the development of this approach. We will look into the SUMI in more detail, but not until after mentioning the LCID.
The LCID approach starts with the data from the substance supplier at the top of the supply chain. In situations where no SUMI is available, the LCID method calculates the components in a mixture that contribute the greatest hazards. These are the so-called “lead components”.
The assumption underlying LCID postulates that if a worker is protected from the lead component hazards, the OCs and RMMs that ensure adequate protection will also protect against the lesser component hazards.
The LCID method involves some complex algorithms and calculations. More information is available from chemical supplier sector associations, Cefic and VCI, but we will not go into further detail on LCID here.
The first hurdle: SWEDs
On the way to developing SUMIs, representatives of the DUCC Mixtures Task Force identified a key need: in order to accurately communicate information on the safe downstream uses, the upstream suppliers need to know what these uses are. So the SUMI effort actually starts with a template for facilitating this communication: the Sector-specific Workers Exposure Description (SWED). SWEDs describe the average or standard conditions of use of chemical products by downstream users. This description of the workers’ exposure must be plugged into the upstream supplier’s CSA, ensuring that the ESs for each substance will cover the end-uses in the supply chain.
In addition to telling upstream suppliers the use descriptors of the downstream users, these SWEDs also provide clues on the OCs and RMMs currently in use. REACH requires that these OCs and RMMs be evaluated with the intent of proving, quantitatively if possible, that workers will not suffer harmful effects from chemicals.
Similarly, specific consumer exposure determinants (SCEDs) and Specific Environmental Release Categories (SpERCs) contribute to ensuring that the public and the environmental exposures are within safe limits.
For each SWED, one SUMI will be developed. In simple English: for each worker use or activity, a safe use information document will be developed. The SUMI documents follow a prescribed format. The language in the SUMI should be relevant to and understandable by the worker using the product.
The SUMIs include five mandatory/common chapters.
General description of the process covered.
Two optional chapters may be included, to be adapted to the needs of each sector.
Additional good practice advice.
Additional information depending on product composition.
It is important to note the function of the disclaimer includes highlighting the fact that the SUMI is not a replacement for the SDS.
More details on the SUMI template, format and content can be found in the DUCC document Sector-specific Approaches Towards Developing and Communicating Information for the Safe Use of Mixtures available on the DUCC website.
Although there is one SUMI to each SWED, there may be many SUMIs to one SDS, since each of the SWEDs describe just one activity within a range of possible activities involving the same product. For example, one SWED may describe use of a product by wiping but another SWED may describe the use of the same product by spraying. The two SUMIs corresponding to both SWEDs would be annexed to the same SDS.
There may also be situations where one SUMI is attached to many SDSs, in the case that one set of OCs and RMMs suffices to cover the hazards for a range of similar products.
When to use a SUMI
A simple flow chart (see Figure 1 below) helps downstream users to decide when it is appropriate to use a SUMI. In the first step, the downstream user’s mixture is classified in accordance with the CLP. If a mixture is not classified, the downstream user has no further obligations.
If the product is classified as hazardous, then the user should determine if the SUMI approach can apply. In practice, this will become easier as “libraries” of SUMIs become available on the websites of sector associations working to create standardised communication tools.
In the early phrases of implementation, this represents more of a strategic question: “should my company be working with, or tracking the work of, our sector association, in the anticipation that a SUMI appropriate for this product will be developed?”
Validating the SUMI
Once the appropriate SUMI is located or developed, the user will have to validate that the SWED upon which the SUMI is based correlates appropriately with its actual conditions of intended use of the product. This will consist, at a minimum, of verifying that the OCs and RMMs correspond with the intended use. Depending on the product and sector, it may be necessary to check other factors such as the concentration, minimum tolerable derived no-effect level (DNEL), etc.
In case the formulator discovers the SUMI cannot be validated, there are several options that can be followed.
Develop a SWED representing the actual intended use/activity, and the corresponding OCs and RMMs in current use. Send this upstream with a request that the supplier should address the use described in the new SWED in the ESs supplied.
Apply the Cefic/VCI LCID methodology. This assumes that the uses are covered in the supplier’s ESs, so that the safety information resulting from the LCID method can be validated for the intended use.
Perform their own CSA using the actual SWED.
In this case, the formulator will obtain an ES for the mixture and the exposure scenario must be appended to the SDS. The SUMI approach is no longer applicable. Also note that the downstream user intending to perform its own CSA is under obligation to notify ECHA within six months.
The essentials of SWEDs and SUMIs
The DUCC guide Sector-specific Approaches Towards Developing and Communicating Information for the Safe Use of Mixtures offers the following overview of the essentials.
Communication format for upstream communication
Communication format for downstream communication
Contain the input parameters for a CSA — Workers Exposure (provide the exposure determinants)
The output of the sectorial “bottom-up” approach, tailored-made for the end user
Mixtures (uses of)
Mixtures (uses of)
Content based on
Sectorial information about workers use of the mixtures/sector use maps
CSA — workers’ exposure assessment (by registrants)
Communication downstream — append to or integrate the SUMIs within the SDS of the mixture (by formulators)
Validation of the incoming ES for substances — to check if the conditions described in the ES for each substance in the mixture are covered by the conditions described in the SWEDs (by formulators)
Providing safe use information — professional and industrial end-users (workers) to follow the conditions described
Where to be found
On the sector website
On the sector website
In the Cefic “Overview table of the associations activities” 15
In the Cefic “Overview table of the associations activities” 16
“Specific” to a sector
“Specific” to a sector
They are not substance-based
They are not substance-based
They may be complemented with a SpERC for full description of the use, since they do not address the environmental exposure
They need to be supplied together with an SDS
The publication of the guidance documents outlining the work of the task forces delegated to design the top-down and bottom-up approaches to communicating safe use information for mixtures is a major step towards continuing the flow of information down the supply chain. However, the mixtures situation remains confusing as the kinks in the practical application of this guidance come to light.
What happens before 2018?
The final deadline for registration of substances does not close until 2018. This means that for any given mixture, some substances may have an eSDS while others do not yet have any information. Even if the SUMIs will be developed by a consortium of industry users, they will still need to use their expert knowledge to decide which substances in the mixtures will have safety information that is relevant to communicate, which will be difficult without all of the relevant information available.
Even if a decision is made that the key components have information available and a SUMI is developed accordingly, this decision will have to be revisited as the ESs for the remaining substances are received.
What if some uses have been missed?
The eSDS may not have ESs that cover all of the necessary uses. Even if the eSDS has arrived for every substance in a mixture, it is likely that miscommunications or disconnects between actual uses and uses covered in ESs will be found. At this point, should the SUMI be developed to the best extent possible based on the information already available? Does that in any way resemble conducting an own safety assessment, thus triggering ECHA notification obligations? Or can the creation of the SUMI be deferred until the information availability is complete?
Will SUMIs be available only as a library of portable format documents?
Probably the question I have heard loudest when training or raising awareness of this new guidance is: Will the documents be a library of documents in a portable document format or will these be created in a format capable of being loaded into automated SDS authoring systems? Companies accustomed to managing SDS distribution with software designed for this purpose would like to see the concept more integrated. This is particularly important due to the need to provide these documents in a language that is understood by the workers using the product.
What is the difference between a SUMI and a workplace safety information card?
At first glance, the documents appear similar. In approximately one to two pages, a SUMI describes the required personal protective equipment (PPE), the safe handling and storage, and the approved OCs. Yet a SUMI does not contain many of the elements of the workplace information cards that are required or encouraged by national regulations throughout the EU.
Where a workplace information card is required, the SUMI introduces an extra step for the safety team at the company using the chemical product, because the information in both documents must be compared to ensure it is consistent. Additionally, it is required to communicate the SUMI to the worker, so the worker ends up getting two documents that may be largely redundant.
Surely good solutions for these issues will be developed, but as every professional involved in this work knows the transition periods until processes are smoothed out can be stressful.
Who ensures that the documents really are understood by the workers?
Some of the first examples of SUMIs are being shown in training sessions around the EU now. Attendees who look closely may see that there are weaknesses still to be resolved. For example, if the SUMI for professional use of a drain unblocker tells a professional custodial worker to “prevent that the undiluted product reaches surface waters”, what is to stop them from thinking that it is fine to dilute the product before disposing of it in the lake?
Summary — the benefits outweigh the drawbacks
In spite of the questions, in the view of the author, the SUMI approach offers a lot of advantages.
It will help to clarify and promote the communication from the bottom of the supply chain towards the top-level manufacturers and importers, which is a new way of thinking for many and a difficult process to get running smoothly, especially for small and medium-sized enterprises (SMEs).
It will also help ensure that the safety advice “recommended” by suppliers is not too far off from the actual current practices — industry needs the REACH activities to confirm that their existing safety measures are adequate and identify the unusual cases where they are not. Companies cannot support an outcome in which suppliers create costly requirements for new safety and environmental protection equipment, or significantly upset efficient manufacturing processes, unless there is a real hazard being avoided by the effort.
The support and co-ordination of the sector associations will promote consistent messages and help alleviate the burden of compliance with what amounts to a tremendous amount of new requirements for SDS authors.
End-users will benefit by getting a limited library of SUMIs that are consistent for similar products with similar uses, even if there are multiple suppliers of these products. End-users will also get information that is simple and concise.
Co-ordination by sector associations will promote the use of standardised phrases which can be added to the ESCom standard phrase catalogue. This will facilitate provision of the SUMI documents in all languages necessary.
REACH does not set a specific time frame for when the information from eSDSs must be incorporated in the communications of actors down the supply chain. Worryingly, the REACH requires that SDSs be updated “without delay”.
Suppliers shall update the safety data sheet without delay on the following occasions:
(a) as soon as new information which may affect the risk management measures, or new information on hazards becomes available;
— REACH Article 31(9)
In practice, companies receive most new information on supplier SDSs. Some delay occurs inherently as the person responsible to type this data into their own company’s database(s) works through backlogs and makes the new information available for SDS authoring. Further delay is inevitable as the authors review the new information, trying to make sense of it or contacting suppliers for more information.
There is also a question of the feasibility for users to manage the change if updates are made with every bit of new information that dribbles in. For example, a complex mixture may contain dozens of substances. “New information” can arrive daily or weekly due to regulatory updates, supplier eSDS updates and more. Imagine the company that purchases this complex mixture getting two or three revisions of its SDS each week.
In fact, the text stating “without delay” needs to be taken with at least a small dose of “efficient, proportionate and relevant”. Most companies establish written procedures ensuring that new information channels are actively managed, that the data gets to the right place efficiently, and that SDS updates occur based on a combination of reasonable update frequency and evaluation of the urgency of communicating the new information. Significant information, like new recommendations following a significant industrial incident, may even rate a “bulletin” approach while continuous improvement recommendations will be managed “without delay” in accordance with the normal update process.
Companies should now evaluate their procedures to ensure that they are addressing the new flows of information in the eSDSs as well as in the annexes or SUMIs that their suppliers provide. Enforcement authorities continue to demonstrate tolerance regarding timeline obligations of REACH as it is evident that industry is making good progress and working diligently towards implementing new processes for compliance with this very complex new set of requirements.
The sector associations will push their efforts forward, with the development of Chesar input files and the selection of phrases to be proposed for the ESCom phrase catalogue. Keep an eye on your sector association’s website for progress in the development of SUMIs covering the typical products and uses in your industry.
Most of all, roll up your sleeves because it is time to get to work.