Let’s take it from the top?
While this is often a great approach to trying something again in hopes of getting better—especially during a rehearsal—it is not necessarily the only approach available when you’re dealing with mixtures.
As Martina Frenette, Sphera’s senior regulatory analyst, explains in her new e-book titled “Bottom’s Up: SUMI Offers Substantive Changes on Dealing With Mixtures,” there are now two methodologies in play for how formulators must convey safe-use information down the supply chain for mixtures: the “top down” and the “bottom up” approaches.
The “top down” approach is also known as the Lead Component Identification (LCID) methodology, which follows the theory that if exposure risks are controlled for the most hazardous substances in a mixture, then all risks will be under control as well. However, as Frenette writes: “This is at best a haphazard way for subject-matter experts, who might not have the skills or time to complete these tasks, to operate.”
Alternatively, there’s a new methodology in town: the “bottom up” approach or Safe Use Mixture Information (SUMI) that focuses on understanding the end use of the mixture for a specific sector. As Frenette writes, “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.”
SUMIs, themselves, are concise one- or two-page summaries that include information like respiratory, eye and hand risks as well as “Contributing Activity,” “Process Category” and “Maximum Duration.”
To stay in compliance through SUMI, formulators must embrace automation. This is why Sphera worked with our clients to create the best approach possible. It is based on the European Centre for Ecotoxicology and Toxicology of Chemicals Targeted Risk Assessment (ECETOC TRA) tool.
“The Sphera software solution will be all-encompassing,” Frenette writes, “introducing an editor for relevant use map and SWED [sector-specific worker exposure description] data, validation check logic, audit, SUMI template and much more.”