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THE PAST DECADE’S ROLLOUT of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulations has had a profound effect on the way companies do business in the European Union. While some organizations have turned to a “top-down,” or Lead Component Identification (LCID) approach, others have gravitated toward a separate “bottom-up” strategy.
The ‘Bottom-Up’ Approach
The “bottom-up” approach or Safe Use Mixture Information (SUMI) selection method was developed by sector organizations representing formulators (e.g., Downstream Users of Chemicals Co-ordination groups [DUCC] and associations, such as the International Association for Soaps, Detergents and Maintenance Products [AISE] and the European Council of the Paint, Printing Ink and Artists’ Colours Industry [CEPE], etc.).
The bottom-up approach is focused on understanding the end use of the mixture for a specific industry sector. In this approach, industry sectors are expected to develop safe-use information based on both the foreseen uses and the common mixture characteristics of their sector.
Concretely, the approach led to the creation of SUMIs, a concise one- or two-page document presenting safeuse information (risk management measures and operational conditions) for end users. SUMIs are generic and use short and clear standard phrases and pictograms to illustrate things such as what personal protective equipment is needed, thus minimizing the chances for mistranslation in multilingual Europe.
SUMI at first glance is simple. The difficulty is finding which SUMI or SUMIs apply to a formulator’s mixtures based on use and, more importantly, demonstrating that the information provided offers adequate guidance and protection that guarantees the safe use of a specific mixture for which it is assigned.
This approach is focused on understanding a mixture’s end use by specific industry sectors
The Burden of Proof
To understand how one can end up proving that generic SUMIs assigned to a mixture convey appropriate exposure and protection guidance to guarantee safe use, one must understand the process that led to the creation of SUMIs in the first place.
WARNING: When you first look at any regulation/ requirement, it can be unnerving. It means learning a whole new language and understanding how the terms fit together. This is no different with SUMI. There are many new terms, initialisms and acronyms to untangle.
Let’s begin with sector use maps.
The sector use maps, also known as “use-mapping tables,” were originally developed in 2009. The original intention was to streamline the use-map information shared between downstream users, including the formulators and registrants.
These use maps have been significantly improved as it pertains to the format and content to ensure consistent communication throughout the supply chain.
The use maps contain information that is pertinent to both the registrant and downstream users such as the use descriptors (i.e., sector of use, product category/ process category, etc.), operational conditions, Risk Management Measures (RMM) and any other additional information that might be of importance. To ensure accessibility to all parties involved in the supply chain, a central repository has been created on the European Chemicals Agency (ECHA) website to facilitate this effort, making them accessible to both registrants and downstream users.
The use maps address environmental, worker and consumer exposure, which are known as exposure assessment inputs. Regarding the use maps, templates have been established to facilitate the standardization of information by each industry sector. Even though the use maps cover these three exposure types, the SUMI approach currently only addresses worker exposure. Environmental and consumer exposure information can be included on the SUMI document but under “additional information” if deemed relevant for an industry sector.
The exposure assessment input for workers is known as a sector-specific worker exposure description (SWED). The other two exposure descriptions are specific environmental release category (SpERC) and specific consumer exposure determinants (SCED). Since the SUMI approach is based on worker exposure, let’s focus our discussion on SWEDs.
SWEDs are developed by industry sectors, using the template format, and contain all relevant information pertaining to worker exposure such as operational conditions, RMMs and any other relevant information of value to ensure worker protection. This information can be used by registrants as input into their chemical safety assessments (CSA). Also, formulators can use the SWED data to compare against the exposure scenario of the substances in the mixture. To facilitate this process, the goal is for the registrants to include the SWED code, an alphanumeric character set assigned by each industry sector, to the substance exposure scenarios simplifying the validation process that must be conducted by formulators. Unfortunately, this process was established after the bulk of substance registration had been completed.
To make things even more interesting, a SWED can cover the whole process that a worker would need to perform or cover only the individual tasks, i.e., only preparation, loading, etc. CEPE is an example of an industry sector that established SWEDs that include all activities that a worker would need to perform for a specific use, while AISE developed SWEDs for each individual activity.
Industry sectors may also develop SWEDs for different degrees of hazards such as different concentrations of a substance in a mixture, etc. Even though there is a template format to gather the data, the structure of information is dependent on each industry sector, which creates a challenge for those companies whose mixtures could be covered by several sectors.
Once the formulator has identified the appropriate industry sector applicable to the mixture, a validation process must be conducted to ensure that the SWEDs selected for the specific end use of the mixture are covered by the exposure scenario of the substances. As previously stated, the formulator will need to cross- check the operational conditions and RMMs listed in the SWED against the exposure scenarios of the substances in the mixtures. Depending on the industry sectors, additional validation checks might be required. In the case of CEPE, the formulator must validate that the risk from the use of the mixture is controlled in a way that the exposure estimation for the specific SWED does not exceed the derived no-effect levels (DNEL) of the relevant ingredients. Unfortunately, there is no standardization on the validation check, so formulators must familiarize themselves with the specific requirements of each industry sector.
The last piece of the puzzle for the bottom-up approach is selecting the appropriate SUMI to be appended to the mixture SDS in the same fashion as we would append an exposure scenario to the substance SDS. The format of the SUMI was developed by DUCCs to streamline the communication of safe-use information to downstream users. It only includes information from the SWED that is relevant to the end user in a language that can be easily understood.
Since the format and content of the SUMI is guidance and not prescribed by regulations, each industry sector has created its own flavor of the SUMI document, so standardization—as would be expected—is not the case.
The relationship between the SUMI and SWED is a 1-to-1 ratio. Subsequently, there could be multiple SUMIs for a given mixture. The reason for the multiple SUMIs for a given mixture is that the SWED could cover the whole process performed by a worker or just specific activities, which was addressed earlier. To go a step further, a SUMI is use-oriented; therefore, the same SUMI can be applicable for multiple mixtures. It may seem complicated, but that is not the case.
Each SWED has an alphanumeric character set assigned to it linking the SWED code to the SUMI. The most difficult task in the bottom-up approach is the SWED validation process.
The SUMI approach was designed for companies belonging to an industry sector. What about those that do not? The truth of the matter is that some of them may not want to pursue the top-down approach, or LCID, due to the data requirements. There is nothing stating that they cannot apply the bottom-up approach for their mixtures; however, realistically, another approach might need to be established to address this gap.
Another issue with the SUMI approach is the oversimplification of the supply chain. The assumption is that a formulator will append the SUMI to the mixture SDS for their downstream users. What if the mixture is sent from the formulator to another formulator? Is there sufficient information in the SUMI document for the second formulator to validate and append their SUMI for their downstream users?
This concern was raised at the 11th meeting of the Exchange Network on Exposure Scenarios (ENES) – ECHA in November 2017 but regrettably, there is no guidance on addressing this gap at this time.
Besides the need to streamline the distribution of the information in a usable format throughout the supply chain, formulators need automation where it brings the most value.
This is the process to validate that “safe use” can be somewhat proven if a user applies the risk-management measures and respects operational conditions and proper use conveyed in a SUMI. Use map and SWED data can be provided as content, but logic to validate if the SWED assigned to a mixture is safe for use is not an easy endeavor, especially since no standardization has been established.
Sphera worked jointly with clients to determine the best approach for a software solution, which is based on the European Centre for Ecotoxicology and Toxicology of Chemicals Targeted Risk Assessment (ECETOC TRA) tool. It is the tool used by most registrants for exposure assessment, which is a logical approach.
The solution incorporates various checks to ensure that the substance exposure scenarios are aligned with the SWEDs, such as risk characterization ratios (RCR), Minimum Tolerable DNELs, etc. Clients will also have flexibility to apply their own custom validation check to meet their business needs. The Sphera software solution will be all-encompassing, introducing an editor for relevant use map and SWED data, validation check logic, audit, SUMI template and much more.
The future is still not set in stone. As industry begins using the SUMI or LCID approach, “tweaks” to these methodologies are expected to address data and process gaps. Perhaps we will see the emergence of new approaches, but only time will tell.